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Capital Reporting CompanyHomeopathic Product Regulation 04-20-2015
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Homeopathic Product Regulation:
Evaluating the Food And Drug Administration's
Regulatory Framework After a Quarter-Century
Part 15 Public Hearing
Day 1
Monday, April 20, 2015
9:00 a.m.
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg 31, Room 1503(A)
Silver Spring, Maryland 20993
Reported by: Michael Farkas Capital Reporting Company
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1 A P P E A R A N C E S
2 JANET WOODCOCK
3 JOHN WHYTE
4 EDWARD P. KRENZELOK
5 ADRIANE FUGH-BERMAN
6 MICHAEL DEDORA
7 WAYNE B. JONAS
8 LISA AMERINE
9 AMY ROTHENBERG
10 BRUCE H. SHELTON
11 JEANNINE RITCHOT
12 MELANIE GRIMES
13 MARCEL FRAIX
14 M'LOU ARNETT
15 ALISON TEITELBAUM
16 JANINE JAGGER
17 MARK LAND
18 MARK PHILLIPS
19 ERIC FOXMAN
20 BARBARA A. KOCHANOWSKI
21 PEGGY O'MARA
22 LUANA COLLOCA
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1 APPEARANCES CONTINUED:
2ALYSSE WOSTREL
3NANCY PEPLINSKY
4TANYA KELL
5ANTHONY VOZZOLO
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1 C O N T E N T S
2 SPEAKER: PAGE NUMBER:
3 John Whyte, Moderator 6
4 Janet Woodcock, Director, CDER, FDA 6
5 Edward Krenzelok, Rocky Mountain Poison and Drug Center 17
6Adriane Fugh-Berman,
7 Georgetown University Medical Center 35
8 Michael DeDora, Center for Inquiry 50
9 Wayne B. Jonas, Samueli Institute 62
10 Lisa Amerine, Homeopathic Academy of Naturopathic Physicians 87
11Dr. Bruce H. Shelton, Arizona Homeopathic
12 and Integrative Medical Association 131
13 Jeannine Ritchot, Health Canada 153
14 Melanie Grimes 173
15 Dr. Marcel Fraix, Western University of Health Sciences 179
16M'Lou Arnett, Matrixx Initiatives, Inc. 191
17Alison Teitelbaum,
18 Natural Center for Homeopathy 203
19 Janine Jagger, Familial Mediterranean Fever Found. 210
20Dr. Mark Land, Mark Phillips, Eric Foxman 218
21 American Assoc. of Homeopathic Pharmacists
22 Barbara A. Kochanowski, Consumer Healthcare Products Assoc. 248
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1Peggy O'Mara 259
2Luana Colloca, Univ. of Maryland, Baltimore 269
3Alyssa Wostrel,
4 Integrative Health Policy Consortium 287
5 Nancy Peplinsky, Holistic Moms Network 301
6 Tanya Kell, North American Society of Homeopaths 311
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1 P R O C E E D I N G S
2 DR. WHYTE: Well, good morning,
3 everyone. I'm Dr. John Whyte. I'm the Director of
4 Professional Affairs and Stakeholder Engagement
5 Group here at the Food and Drug Administration at
6 the Center for Drugs Evaluation and Research, and
7 I'll be serving as the moderator for today's
8 hearing.
9 We're on a strict timeline today so I
10 want to go ahead and get started, and I'm
11 delighted to present to you Dr. Janet Woodcock,
12 who is the Director of the Center for Drugs
13 Evaluation and Research.
14 DR. WOODCOCK: Thanks very much, John.
15 Good morning, everyone. Thank you very much for
16 coming to this. I'd like to welcome you to this
17 two day hearing on FDA's regulation on drug
18 products labeled as homeopathic.
19 We recognize that this topic is of great
20 importance and of interest to industry and other
21 stakeholders based on the number of presenters
22 scheduled to speak here today and tomorrow.
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1 I want to thank you for all your
2 interest in this topic and thank the people in the
3 webcast, and hope that they are able to access
4 this event.
5 By providing specific feedback to our
6 questions and our preliminary concepts, through
7 your oral testimony and written comments to FDA's
8 dockets, you will help us develop the appropriate
9 path forward.
10 The Federal Food, Drug, and Cosmetic
11 Act, and I'll refer to it as the ACT, recognizes
12 articles listed in the Homeopathic Pharmacopoeia
13 of the United States as drugs. FDA has clear
14 regulatory authority over drug products labeled as
15 homeopathic, just as it does with all products
16 that meet the definition of "drug" in the ACT.
17 And I know there's been a great deal of confusion
18 about this, but yes, FDA has authority over drugs
19 that are labeled as homeopathic.
20 However, under FDA's current enforcement
21 policies that were issued in something we call a
22 Compliance Policy Guide, in 1988 drug products
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1 labeled as homeopathic are marketed without pre-
2 market approval, provided those products are
3 marketed in accordance with certain conditions,
4 including ones related to labeling and
5 manufacturing.
6 So, it isn't that homeopathic drugs are
7 not regulated by the FDA, they are regulated as
8 drugs, it's simply they have a different structure
9 right now under this compliance policy guide
10 that's been in effect for a long time as far as
11 how they are regulated.
12 Today, prescription and non prescription
13 drugs labeled as homeopathic are a multi-billion
14 dollar industry in the United States.
15 A majority of drug products that are
16 labeled as homeopathic are marketed and sold
17 direct consumer through magazines, the internet,
18 and in both the big box retail establishments and
19 traditional pharmacy retail outlets.
20 Prescription drug products labeled
21 homeopathic also exist and are available through
22 both online pharmacies and through practitioners
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1 licensed to dispense prescription drug products.
2 So there are several outlets -- great over-the-
3 counter use, direct to consumer, and also
4 prescription use.
5 Typically drug products are brought to
6 the market through the new drug approval process,
7 or via an over-the-counter monograph, and these
8 are two regulatory structures that FDA has in
9 place to allow new drugs or traditional drugs to
10 be marketed.
11 In contrast, both prescription and non
12 prescription drug products that are labeled as
13 homeopathic are manufactured and distributed
14 without FDA approval, and without being subject to
15 any FDA monograph under the Agency's enforcement
16 policies that were set forth, as I mentioned, in
17 this compliance policy guide. So, that is the
18 regulatory -- currently regulatory regime for
19 these homeopathic products.
20 The public hearing, we hope, will allow
21 FDA to obtain information about such products in
22 an effort to better promote and protect the public
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1 health, which is what we do, which is our mission.
2 And we want to make sure that patients have the
3 necessary information to make informed choices
4 about products labeled as homeopathic, as well as,
5 of course, make sure that all those products are
6 appropriately safe for people to use.
7 FDA is seeking input on several
8 questions regarding products labeled as
9 homeopathic, that include various topic areas;
10 consumer and healthcare provider attitudes,
11 potential data sources that could be used to
12 assess the risks and benefits of the products, our
13 enforcement policies, and the evaluation processes
14 for over-the-counter products, and labeling.
15 These are just a few of the many items
16 that we hope to gain a great deal of information
17 and insight on over the next two days of this
18 meeting.
19 So, in closing, homeopathic products are
20 of interest and are used by many Americans. They
21 are available both by prescription and greatly
22 through over-the-counter sources. FDA has clear
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1 regulatory authority over these products, however,
2 under our Compliance Policy Guide, we basically
3 are mainly looking at instances where there's
4 reports of harm, or other reports, when we
5 regulate these products, and they're not subject
6 to the kind of premarket review or monograph that
7 all the other traditional drug products are
8 required to comply with.
9 So, we seek information. It's time for
10 an update. It's time to look at how we're
11 regulating this class of products, and we really
12 look forward to your input, and thank you very
13 much for being here. Thanks.
14 DR. WHYTE: Well, thank you, Dr.
15 Woodcock. So, as Dr. Woodcock said, this is being
16 webcast, so I thought I would give you the web
17 address if you want to take out any pen and paper.
18 It's www.collaboration.fda.gov/hprapril2015.
19 Again. www.collaboration.fda.gov/hprapril2015.
20 All right. Just a few housekeeping
21 rules before we get started because we're all
22 excited to have this discussion. I know a lot of
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1 you have travelled to come here and we have, as
2 you can see, a packed room.
3 This meeting will be held in accordance
4 with Part 15, and that's a special type of
5 hearing, part of the 21CFR, Part 15. I want to
6 remind you that the hearing is informal and the
7 rules of evidence do not apply.
8 I ask that no participant interrupt the
9 presentation of any other participant, only the
10 presiding officer and panel members may question
11 any person during or at the conclusion of each
12 presentation. This really is a listening session
13 on behalf of the Food and Drug Administration.
14 So, I'm going to call you up to the
15 podium by name when it's your turn and I'll ask
16 you to introduce yourself. I ask that you state
17 your name and organization for the record.
18 In anticipation of the hearing
19 presentation moving ahead on schedule, I really
20 encourage you to arrive early, so if any
21 colleagues or friends are coming, I do ask that
22 you have them come a couple of hours early because
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1 things can move quickly. If you're not present
2 when you're called upon, you actually may forfeit
3 your time. Those are the general rules of the
4 hearing.
5 If you have any financial interest
6 relevant to the meetings, such as a financial
7 relationship with any company or group that may
8 be affected by the topic of this meeting, the FDA
9 encourages you to state that interest when you
10 begin your presentation. If you don't have any
11 such interest, you may wish to state that for the
12 record as well.
13 And I must add, if you prefer not to
14 disclose your financial interest, you can still
15 give your presentation.
16 I do want to remind you that
17 presentations will be strictly limited to the time
18 allocated in the agenda, and hopefully all of you
19 have a copy of the agenda. There's a timer right
20 up here that you'll be able to see when you
21 present. It will turn yellow when there's 30
22 seconds remaining for each presentation.
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1 So, again, when it flashes yellow,
2 that's 30 seconds, and this will be your warning
3 to conclude your talk.
4 The light will turn red when your time
5 is up, and I'm told that the microphone will cease
6 to work. So hopefully we won't have to resort to
7 that and we can all be gentile and conclude our
8 time when the red light comes up. I don't want to
9 have to be a traffic cop.
10 And following each presentation, there
11 will be a period of five minutes, which will also
12 be strictly enforced, where the panel members
13 actually can ask any follow-up questions, or I may
14 have an opportunity to ask you to clarify
15 anything.
16 I do want to add, after the meeting,
17 because people always ask about -- you know, "I
18 didn't get a chance to talk at the meeting," or "I
19 wanted to make these other comments," if you do
20 have additional information, or you know other
21 folks that want to present information to the FDA,
22 you can still submit electronic comments regarding
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1 the public hearing to regulations.gov, and any
2 written comments to the Division of Dockets
3 Management, and I don't know if we'll have a slide
4 where we can put that, but I'll give it to you
5 just in case. It's 5630 Fishers Lane, Room 1061,
6 in Rockville, Maryland.
7 You can annotate and organize your
8 comments to identify specific questions on the
9 topic to which they refer, but I do want to
10 caution you that they must be received by June
11 22nd, 2015.
12 So, again, there is opportunity to make
13 any additional comments or opposing questions, and
14 you have until June 22nd, 2015.
15 One other housekeeping note, we will
16 have a break this morning prior to lunch, and
17 during that time I encourage you -- there is a
18 kiosk where you can preorder your lunch, so you
19 might want to do that because you will not be able
20 to enter other aspects of the building, such as
21 the FDA's cafeteria. So if you want to order
22 lunch, there will be a kiosk where you can
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1 preorder.
2 With that, I'll turn to the panel who
3 will have an opportunity to introduce themselves.
4 DR. BENT: Hello. Good morning. My
5 name is Dr. Kate Bent. I'm the Assistant
6 Commissioner for Compliance Policy in the Office
7 of Regulatory Affairs.
8 DR. IZEM: Good morning. I'm Dr. Rima
9 Izem. I'm a Team Leader in the Office of
10 Biostatistics.
11 MS. LIPPMANN: Good morning. My name is
12 Elaine Lippmann. I'm Regulatory Counsel in the
13 Office of Regulatory Policy.
14 DR. LOSTRITTO: Good morning. I'm Rick
15 Lostritto. I'm a Division Director in the Office
16 of Policy for Product Quality. I'm also the
17 acting Associate Director for Science in that
18 office.
19 MS. MICHELE: Good morning. I'm Teresa
20 Michele. I'm the Division Director of Non-
21 Prescription Drug Products in the Office of New
22 Drugs.
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1 DR. NELSON: I'm Dr. Robert Nelson. I'm
2 Deputy Director of the Office of Pediatric
3 Therapeutics in the Office of the Commissioner.
4 MR. PACE: Hi. I'm Brad Pace. I'm
5 Regulatory Counsel in the Office of Compliance in
6 the Center for Drugs.
7 MR. WU: Good morning. My name is
8 Charles Wu. I'm part of the review team of the
9 Office of Pharmaceutical Quality.
10 DR. WHYTE: I'll also introduce our
11 timekeepers for the day. I should caution, this
12 isn't their day job, so please indulge us. Dave
13 Boggs and Imo Zadezensky. So they will help us
14 also with any issues that you may be experiencing.
15 It does look very high tech when you get
16 up here, in front of you, but just use this little
17 gadget to advance your slides forward if you're
18 using any slides.
19 And with that, we'll go ahead and get
20 started. Our first speaker is Edward Krenzelok
21 from the Rocky Mountain Poison and Drug Center.
22 MR. KRENZELOK: Good morning. Thank
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1 you, Dr. Whyte, Dr. Woodcock, members of the
2 panel, members of the audience. It's certainly a
3 pleasure to be here. Here we are.
4 So, I'm Edward Krenzelok. I am a
5 consulting Clinical Toxicologist with the Rocky
6 Mountain Poison Center in Denver. I'm a former
7 Director of the Pittsburgh Poison Center, for
8 about 30 years, and I also hold the position and
9 title of Professor Emeritus (ph) at the University
10 of Pittsburgh School of Pharmacy.
11 This study, the data, that I'm going to
12 discuss this morning was funded by a grant to the
13 Rocky Mountain Poison Center by the Consumer
14 Healthcare Products Association, and I'm -- my
15 time is being compensated by the Rocky Mountain
16 Poison Center.
17 And I would like you just to pay
18 attention -- this is a very long disclaimer from
19 the AAPCC -- but as we get down here to the end,
20 "exposures do not necessarily represent poisoning
21 or overdose," and I think that's the key part of
22 this that I'd like you to remember during my
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1 presentation, if you would, please.
2 So, I don't know if you know a lot about
3 America's poison center system, but there are 55
4 Poison Centers in the U.S. They all belong to
5 the American Association of Poison Control
6 Centers. They are all connected via a universal
7 800 number, so if you have a poisoning, an
8 exposure, and adverse reaction, something of that
9 nature, call 1- 800-222-1222. It will route you
10 to the nearest poison center in any of the 50
11 states or any of the U.S. Territories.
12 These services are available every day
13 of the year, 24 hours a day, so it's a wonderful
14 emergency service.
15 Every case that comes in, every
16 exposure, every inquiry, is documented
17 electronically on a medical record. Those data
18 are then auto uploaded automatically to the
19 National Poison Data System at the AAPCC, so it's
20 a real time database of all exposures that are
21 reported.
22 Every year the AAPCC publishes its data
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1 and you can data and you can see a citation right
2 here, and at the conclusion of my slides are eight
3 references for the eight years of data that I'm
4 going to discuss. And so it discusses both
5 pharmaceutical and non pharmaceutical product
6 exposures.
7 Now, remember, every exposure is not a
8 poisoning. Every exposure is not associated with
9 an adverse event, and the data that I'm going to
10 be addressing today are from the eight year period
11 of 2006 to 2013, and they are single product
12 exposures.
13 So, these aren't multi-pharmaceutical
14 exposures where multiple substances have been
15 ingested. It's single product exposures, and we
16 gleaned all of the data, not from a special data
17 run, but from these publications that you have
18 full access to. If you go to AAPCC.org, all of
19 these data are available for you immediately.
20 I'd like to walk you through, just very
21 briefly, what a call might be coming in to a
22 poison center, and the intake methods.
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1 So, the call comes in to the poison
2 center. It's received by a specialist in poison
3 information who is a Pharmacist or a Nurse,
4 generally. They will then determine if this is an
5 intentional exposure, an unintentional exposure,
6 an adverse reaction, or some other reason for
7 people to call.
8 They'll ultimately issue some
9 recommendations and they'll do follow-up if at all
10 possible, and then report it all to the National
11 Poison Data System. So, again, that forms the
12 basis for the data that I will be discussion this
13 morning.
14 Now, as you can see, there were
15 19,037,967 exposures of all sorts, pharmaceutical
16 and non-pharmaceutical, reported over those eight
17 years to American Poison Centers.
18 If we follow down, we can see that there
19 were just over 12 million single product
20 exposures, and that's, again, what I'm focusing
21 on. Eight million of those were pharmaceuticals,
22 and then as we get down to homeopathic agents,
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1 which is the focus of my presentation, it's 80,456
2 exposures, so, that forms the basis for all the
3 data that I will be presenting to you. And,
4 again, just to reemphasize, these are single
5 product exposures.
6 This breaks down for you on an annual
7 basis as well how many exposures there are and
8 gives you a perspective. So basically, the
9 homeopathic exposures account for about one
10 percent of all exposures reported to American
11 poison centers as they relate to pharmaceutical
12 agents, single exposure, pharmaceutical agents.
13 And I also will be, then, discussing the
14 age of the victims -- of the people that had the
15 exposures -- basically why they were exposed,
16 their outcome, and then ultimately their
17 disposition as well -- were they hospitalized or
18 not -- in my brief presentation.
19 So, let's take a look at this first
20 data, and I'll be comparing those to all
21 pharmaceutical data so you have a perspective on
22 homeopathic products versus all pharmaceuticals.
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1 So, you can see that the vast majority
2 of the exposures as reported to American poison
3 centers involve children less than six years of
4 age. Very clearly -- you know, 92% -- and that's
5 quite different from what it is when we look at
6 all pharmaceutical products in general, whereas
7 all pharmaceutical account for just over half of
8 the exposures reported to poison centers.
9 And then you can see the disparity in
10 the age groups, in six to 19, and greater than 20
11 being adults, and these are the way the data are
12 broken down again in the annual reports. So,
13 there are more definitive data, but those data
14 have to be requested specifically from the AAPCC.
15 So, this gives you a perspective on age, so it is
16 a pediatric issue more than anything else.
17 And then as we look at the reason for
18 exposure -- remember I talked about unintentional,
19 intentional, adverse reactions, and so on --
20 unintentional, think of as accidental exposure.
21 It may be a child getting into a container, or
22 sampling some tablets that were left on a table,
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1 or whatever the exposure may be. Or someone
2 accidentally -- an adult picking up someone else's
3 medication. So those are the accidental or
4 unintentional exposures.
5 And you can see that intentional
6 exposures, which can be suicide, substance abuse,
7 and so on, are extremely low with this particular
8 group.
9 Now, when we compare that to all
10 pharmaceuticals, you can see, again, there's a
11 significant disparity, and the intentional
12 exposures are very significantly different
13 compared to the homeopathic agents, again,
14 probably because they have no abuse potential.
15 And we see a lot of these exposures as
16 being substance abuse -- and then you also will
17 look over here and see that there were some
18 adverse reactions and about twice as many adverse
19 reactions involving regular pharmaceutical
20 exposure as compared to the homeopathic agents.
21 And then, as we look outcome, which is
22 very important, let's look first at the affect.
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1 There is no affect. That basically means it's
2 pretty obvious -- no affect -- the child, the
3 adult, whoever was exposed suffered absolutely no
4 adverse event. And there were -- about 10% of
5 those exposures ended up having some type of a
6 minor event.
7 So, you can see that over 98% of the
8 exposures to the homeopathic agents resulted in
9 either no affect or only a minor affect.
10 Note also that there are a couple of
11 deaths reported. Unfortunately I can't provide
12 you with any information because I'm only
13 providing you with information that was published
14 information, and these data regarding the
15 specifics on these fatalities are sort of buried
16 in the AAPC database and have to be extracted
17 separately.
18 Comparing those to all pharmaceuticals,
19 again, you can see significant differences as in
20 each other slide that I've presented. A lot more
21 minor affects, a lot more moderate affects, major
22 affects -- and there's about a six times
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1 difference in fatality rates between and among all
2 pharmaceuticals versus the homeopathic agents.
3 And then finally, what happens? Where
4 are these people treated? What's their ultimate
5 disposition?
6 So, approximately 5.8% of all of the
7 homeopathic exposure patients end up in an
8 emergency department or seeking some type of
9 healthcare outside of just a call to the Poison
10 Center, versus about five times the number with
11 all pharmaceuticals.
12 And I must tell you that this isn't
13 necessarily because a poison center recommended
14 they go to an emergency department, this could be
15 people going to an emergency department on their
16 own, visiting a physician on their own, and then
17 the poison center receiving a call from that
18 healthcare professional, and that's the way it's
19 documented.
20 So, in summary, about nine to ten
21 thousand exposures, on average a year, over this
22 eight year period of time -- most of the exposures
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1 occurred in small children, 97% were
2 unintentional, and about 98% had no affect or only
3 a minor affect, so relative safety from that
4 standpoint.
5 Only two single substance fatalities --
6 and again, unfortunately I don't have more
7 detailed information to provide to you. There
8 could have been other substances involved somehow
9 that weren't identified.
10 Ninety-five percent were treated without
11 a healthcare facility referral, and there's
12 overall very low morbidity and mortality
13 associated with at least the calls that are
14 retrieved and managed by poison centers.
15 And then the final slide -- again, these
16 are the annual reports as presented -- or as
17 published by the American Association of Poison
18 Control Centers. And again, if you go to
19 AAPCC.org, look under National Poison Data System,
20 it's all available on the front part of their web
21 page.
22 So, with that I conclude my remarks.
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1 Thank you very much for your kind attention.
2 DR. WHYTE: Thank you. And now we'll
3 have five minutes of questions, if we have any
4 questions or follow-up.
5 DR. LOSTRITTO: Thank you.
6 Interesting presentation. I know you said that
7 the details of the data are limited, but in your
8 experience, do you have any indication if any of
9 the moderate or even minor affects that you were
10 seeing in these exposures to homeopathic products
11 could be due to the quality of the excipients
12 used, or to some aspect of the manufacturing
13 process?
14 MR. KRENZOLOK: And I wish I had an
15 answer for you. Thank you very much. As -- what
16 we do -- and some of these calls may have been
17 misrepresented. They may or may not have been
18 homeopathic calls, too.
19 All of the data for manufacturers are
20 submitted to the poison -- it's Micromedics (ph) -
21 - which is the database the poison centers use.
22 Each substance has a unique seven digit code, and
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1 therefore, that seven digit code -- when the
2 poison information specialist receives a call
3 about product "xyz," they put that code in for the
4 medical record and it goes into it. And so they
5 may not realize there's a homeopathic product
6 even. There may not even be full product
7 disclosure.
8 So, in my experience, I would say that
9 there are limited data available on the
10 composition of a lot of these products, and so I
11 don't have a better answer than that.
12 Thank you.
13 DR. NELSON: Thank you. Let me follow
14 that up with a clarifying question. Given the
15 process you just described, are you -- what's the
16 accuracy of the reporting of it being a
17 homeopathic product as opposed to some other type
18 of product that might not be a prescription
19 pharmaceutical?
20 MR. KRENZELOK: Um --
21 DR. NELSON: Can I just follow-up?
22 MR. KRENZELOK: Yeah.
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1 DR. NELSON: And I wonder how much of
2 the trend towards younger children is just based
3 on reporting and parental concern for that age
4 group, as opposed to, you know, to the older
5 children that might still ingest it, but they just
6 wouldn't call.
7 MR. KRENZELOK: Sure. The first
8 question, accuracy, all of the data,
9 unfortunately, that comes into poison centers --
10 you know, we're not out there in the home and
11 taking a look at -- this is the bottle, this is
12 the actual substance they ingested -- and so
13 accuracy is a relative thing, but it's relative to
14 all products, whether they're homeopathic or
15 whether they're OTC or prescription
16 pharmaceuticals.
17 And then with regard to pediatric
18 exposures, I was sort of quizzical about that
19 myself and why there are more pediatric exposures,
20 and the only rationale I can come up with is that
21 perhaps there are few of the homeopathic products
22 that have child resistant closures on them,
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1 therefore giving greater access to children then
2 say a conventional pharmaceutical agent may have
3 that's like an acetaminophen product or aspirin,
4 or something like that that's in a child resistant
5 closure.
6 DR. IZEM: I have a question about the
7 trends over time in what you showed -- is the data
8 aggregated over the whole time period? Did you
9 notice a change over time?
10 MR. KRENZELOK: There was a change over
11 time. You notice it started off kind of slowly,
12 and it peaked, and then it crescendoed, and then
13 it went down, and those numbers more or less
14 parallel call volume at poison centers, and what
15 we've seen, experienced, at poison centers over
16 the last few years is a decrease in call volume
17 because of a greater alliance of people on the
18 internet and parents searching out answers on
19 their own without calling the poison center.
20 That's our opinion, anyway, as to why those
21 numbers are going down. So they really parallel
22 actual poison center exposure numbers.
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1 DR. IZEM: Another question is, in your
2 report, do you separate between OTC versus
3 prescription in either "homeopathic" or "all
4 pharmaceuticals" categories?
5 MR. KRENZELOK: No. And the AAPC data
6 cannot separate and distinguish between OTC and
7 prescription because they're not a separate code
8 that identifies OTC versus prescription.
9 So -- as a matter of fact, we were
10 looking for those data, and I said it's just
11 impossible to really obtain those data, unless you
12 took, perhaps, a single substance, something like
13 antacids, for example, and compared homeopathic
14 products against antacids, or some class -- known
15 class of non-prescription drugs.
16 MR. PACE: You're presenting two kind of
17 classifications of pharmaceutical products with
18 different volumes of use. Can you clarify how
19 these rates may compare to compliment the raw
20 numbers in terms of, you, 80,000? Does that
21 represent a certain percent of the total kind of
22 homeopathic product use?
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1 MR. KRENZELOK: Well, those 80,000 are
2 the homeopathic exposures, and I don't know what
3 that is from a market share standpoint or
4 anything. I'm sorry, I just -- I'm familiar with
5 the poison center data -- if that's what you were
6 getting at.
7 DR. BENT: And can you help us
8 differentiate between the definitions of minor,
9 moderate, and major affects, and do you use the
10 same definitions for the homeopathic products and
11 other exposures?
12 MR. KRENZELOK: That's great, and I
13 meant to explain those and I apologize for not
14 doing that.
15 So, no affect speaks for itself. Minor
16 affect is a self-limiting affect. You know, maybe
17 a little irritation, an episode of, you know, eye
18 irritation or something of that nature. A
19 moderate affect is usually a bit more sustained
20 and it may be -- a minor affect might be vomiting
21 that occurred once. Moderate affect might be
22 multiple episodes of vomiting, and generally
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1 moderate effects are those that persist up to
2 eight hours.
3 Major affects are disfiguring or life
4 threatening, and that's the very clear definition
5 of that. And then fatality speaks for itself.
6 DR. WHYTE: That will be the last
7 question. Thank you.
8 MR. KRENZELOK: Thank you very much.
9 DR. WHYTE: We are -- despite what I
10 told you about this timer up here, we are having a
11 technical timer issue, so we might have to go old
12 school and use our watches, so we'll see.
13 And I apologize in advance if I
14 pronounced -- if I pronounce your name wrong. Mr.
15 Krenzelok and I had an opportunity to meet, so I
16 tested it out. So I apologize if it doesn't work.
17 So maybe we'll wait a second to see if
18 our timer is back functioning. That looks better,
19 although it's -- can we reset? So I beg your
20 indulgence for a minute.
21 I did get a note that some folks on the
22 webcast are having difficulty hearing, so -- I
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1 mean, I thought it was going well, so I do ask
2 that you all clearly speak into the mic. And they
3 did point out, especially on the part of our
4 panelists, to make sure that you talk clearly into
5 the mic so they can also hear.
6 So, it looks like the timer is resent,
7 and hopefully it will work this time, but I'll use
8 my watch as well to ensure fairness, and with
9 that, I'm delighted to introduce our next speaker,
10 Adriane Fugh-Berman from the Georgetown University
11 Medical Center.
12 MS. FUGH-BERMAN: Good morning. I'm
13 Adriane Fugh-Berman. I'm an Associate Professor
14 in the Department of Pharmacology and Physiology
15 and the Department of Family Medicine at
16 Georgetown University Medical Center, where I
17 teach about medicinal plants, dietary supplements,
18 and evidence based medicine. I also direct
19 PharmedOut, which is a project that promotes
20 rational prescribing.
21 I have no commercial conflicts of
22 interest, but I'm a paid expert witness in
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1 litigation regarding pharmaceutical marketing
2 practices.
3 I've authored two books on complimentary
4 medicine. I wrote the first chapter on
5 complimentary medicine in Harrison's (ph)
6 "Principles of Internal Medicine," and I've worked
7 for the Office of Alternative Medicine, which is
8 now known as the National Center for Complimentary
9 and Integrative Health.
10 Between 1998 and 2012, I was also a
11 consultant for the Federal Trade Commission on
12 dietary supplements.
13 I'm concerned about the current state of
14 labeling for homeopathic remedies, particularly
15 OTC preparations. Although the FDA has increased
16 its focus on the safety, quality, and claims,
17 regarding dietary supplements, the Agency has
18 continued to defer its regulatory oversight of
19 homeopathic drugs.
20 Now, in the U.S. we practice -- in the
21 U.S., both classical homeopathy and homeopathic
22 polypharmacy are practiced and the sequestered
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1 racks of individual homeopathic remedies that are
2 ordered or compounded by prescription and
3 administered by those with specialized knowledge
4 have not and should not be of regulatory concern.
5 What I'm most concerned about is the
6 stocking of homeopathic remedies that are labeled
7 for specific symptoms or conditions that are
8 alongside conventional OTC drugs in the pharmacy,
9 or on supermarket shelves.
10 This is innately misleading. Most
11 consumers have no idea what homeopathy is and they
12 may assume that these products or dietary
13 supplements are even conventional drugs.
14 Consumers, and probably most healthcare
15 professionals, are unaware that the FDA does not
16 review homeopathic drugs for safety or efficacy,
17 and while homeopathic drugs are supposed to comply
18 with federal requirements for good manufacturing
19 practices, it's my understanding that the FDA does
20 not routinely review these products for identity,
21 purity, potency, quality, or stability, prior to
22 marketing.
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1 It's generally believed that homeopathic
2 drugs are completely safe because they're highly
3 diluted. From a homeopathic perspective, less
4 diluted remedies are less potent and more diluted
5 remedies are more potent, thus high potency or
6 prescription homeopathic remedies represent the
7 most dilute forms, and these can be considered
8 safe because any homeopathic preparation diluted
9 to 30x or beyond -- that's 30/10 to one dilutions
10 -- is unlikely to have even a single molecule of
11 the original substance left in it.
12 However, most over the counter
13 homeopathic remedies are low potency preparations
14 because they're not highly diluted. These
15 preparations may contain measurable and
16 pharmacologically active levels of ingredients.
17 For example, Cold-EEZE contains 13.3
18 milligrams of zinc per lozenge. At recommended
19 six lozenges a day, that's about 80 milligrams of
20 zinc a day, or ten times the RDA for adult
21 females, or eight times the RDA for males.
22 A similar OTC cold remedy, Zicam, states
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1 that each lozenge contains zincum aceticum and
2 zincum gluconicum at 2x, which represents a
3 dilution of one to 100, or 1% concentration.
4 What consumer or healthcare professional
5 knows what this nomenclature or dose information
6 means? In this case the drug label provides no
7 useful information to the average consumer or
8 clinician, and those who can interpret the
9 concentration still won't know how many milligrams
10 of zinc are in this product.
11 Although zinc is an essential element,
12 excessive zinc can suppress copper and iron
13 absorption and cause other toxic effects.
14 Since any ingredient with a homeopathic
15 proving, that is listed in the homeopathic
16 pharmacopeia of the U.S., qualifies as a
17 homeopathic ingredient, homeopathic remedies can
18 contain snake venom, heavy metals, controlled
19 substances, glandular extracts, and other
20 ingredients that would be considered potentially
21 unsafe by usual drug standards. Even more
22 concerning are companies that sell homeopathic
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1 preparations containing prescription drugs.
2 For example, Guna Interleukin Remedies
3 contains several interleukins and alpha
4 interferon. These are prescription drugs that are
5 approved only for serious conditions. Each has
6 significant label warnings and precautions.
7 The homeopathic OTC version is labeled
8 for chronic pain relief, anti-inflammatory, good
9 for auto-immune. Guna Interleukin 12 is
10 advertised for anti-allergy immune support,
11 asthma, COPD, and bronchitis. The dangers of
12 selling prescription drugs as homeopathic remedies
13 are obvious.
14 It's misleading to sell homeopathic
15 remedies alongside conventional OTC drugs.
16 Allowing homeopathic remedies to sit side by side
17 with conventional drugs that have undergone FDA
18 scrutiny as over the counter drugs is inherently
19 misleading.
20 Consumers may assume that these
21 homeopathic products or phitomedicines (ph)
22 medicines are dietary supplements, and not only do
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1 these homeopathic remedies undergo none of the FDA
2 review that conventional drugs are subject to, but
3 they're not even regulated to the extent that
4 dietary supplements are regulated.
5 Disease claims are disallowed for
6 dietary supplements, but homeopathic remedies can
7 make the same disease treatment claims as
8 conventional drugs.
9 Perhaps homeopathic remedies should be
10 sequestered from other remedies and sold under a
11 banner or label that explains what homeopathy is,
12 with enough information so that a consumer can
13 make an educated decision about purchasing a
14 remedy that may contain no active compounds.
15 The evidence for homeopathy's
16 effectiveness is between scant and nil. This
17 picture has become much more clear over the past
18 20 years. Although there are some positive trials
19 of homeopathy, the benefits tend to disappear when
20 trial analysis is limited to high quality trials.
21 Just this year an assessment of 176
22 studies and 57 systematic reviews from Australia's
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1 National Health and Medical Research Council,
2 concluded that there are no health conditions for
3 which there is reliable evidence that homeopathy
4 is effective.
5 The inclusion of the homeopathic
6 pharmacopeia of the U.S. and the Food, Drug, and
7 Cosmetic Act of 1938, is often considered a
8 concession to Senator Royal Copeland, a Surgeon
9 and homeopathic physician.
10 But the FDA's own historian, Suzanne
11 Junod, has pointed out that that explanation is
12 actually pretty simplistic. At the time,
13 homeopathy was practiced by many physicians. The
14 medical profession was not hostile to the
15 practice. There were more homeopathic physicians
16 in the AMA than there were in the American
17 Institute of Homeopathy.
18 Junod suggests that the inclusion of a
19 physician prescribed class of therapies was an
20 effort to combat fraudulent therapies that were
21 widely sold. While physicians could be held to a
22 code of ethics, charlatans could not. Perhaps the
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1 belief that homeopathy was a dying specialty also
2 played a role in the AMA's passivity at the time.
3 In 1972, the FDA decided to exclude
4 homeopathic products from FDA drug review. The
5 market was considered trivial. The products
6 lacked safety concerns, and once again, homeopathy
7 was considered a dying specialty.
8 The reports of homeopathy's demise,
9 however, has been greatly exaggerated.
10 Ironically, the presence of quack remedies on the
11 market may have contributed to the inclusion of
12 the homeopathic pharmacopeia in the 1938 Act.
13 We need to invoke that spirit once more.
14 Homeopathic remedies should have to disclose their
15 ingredients using modern nomenclature and standard
16 dosing terms.
17 The FDA must reconsider its deferral of
18 regulation over homeopathic drugs. All OTC
19 preparations should have disclose ingredients on
20 the label and how much of each active ingredient
21 they contain.
22 I propose the following recommendations
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1 in order to improve the OTC homeopathic drug
2 label:
3 All active ingredients should be listed
4 using modern chemical scientific language, as FDA
5 currently requires for drugs, foods, and dietary
6 supplements.
7 For plant products, Latin binomial
8 nomenclature, common name, and plant part, should
9 be included.
10 All inactive ingredients should be
11 listed using the same principles as required for
12 conventional drugs.
13 Ingredient quantities should be
14 expressed in standard, scientific format. E.g.,
15 micrograms for tablet, milligrams for milliliter,
16 etcetera, not just homeopathic dilution formats.
17 And any use or indication that would
18 fall under prescription status should be submitted
19 under a new drug application and be reviewed and
20 approved by FDA for product consistency and
21 quality, safety and efficacy, using standard study
22 designs, prior to being marketed in the United
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1 States.
2 If the FDA decides to continue its
3 deferral of regulatory oversight on homeopathic
4 remedies, it's strongly recommended that a
5 disclaimer be added to the OTC homeopathic remedy
6 label to the effect, "This product is a
7 homeopathic remedy. As such, it has not undergone
8 review or approval by the FDA, and therefore has
9 not been documented to be safe or effective to
10 diagnose, treat, prevent, mitigate, or cure, any
11 condition or disease."
12 To date, the lack of regulation of
13 homeopathy has depended on its safety, but it is
14 not safe to have mislabeled, misleading products
15 on the shelves.
16 Thank you.
17 DR. WHYTE: Thank you. Let's restart
18 the timer at five minutes, if we can, and we'll
19 start our questions.
20 MS. LIPPMANN: Hi. You provide some
21 good, helpful detail about the recommendations you
22 have for what the labels should contain for these
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1 products. Do you have an opinion about whether
2 there should be information in those labels about
3 what homeopathy is, what it's based on?
4 MS. FUGH-BERMAN: Yes. Either that or
5 having them in a sequestered area where there
6 actually is an explanation of what homeopathy is.
7 It's very confusing to consumers the way that it
8 is now. They don't understand what homeopathy is.
9 DR. LOSTRITTO: Yes. Thank you. I want
10 to come back to a fundamental labeling issue, and
11 you mentioned that products like Zicam and others
12 are labeled as homeopathic.
13 And I wanted to ask you if you know
14 whether you -- or whether you consider that to be
15 a problem associated with the way conventional
16 over the counter products are allowed to be
17 labeled, or is it a problem associated with the
18 way homeopathic over the counter products are
19 labeled?
20 In other words, is that something that
21 should not have appeared on those over the counter
22 products containing functional levels of zinc?
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1 MS. FUGH-BERMAN: Right. So certainly
2 there are homeopathic products on the market that
3 contain as much of a particular substance that a
4 dietary supplement would contain, but my
5 understanding of the law is that it can be sold as
6 a homeopathic substance -- a homeopathic drug --
7 if the substance is in the U.S. homeopathic
8 pharmacopeia. So even if something is
9 pharmacologically active, it can still be sold as
10 a homeopathic drug.
11 So, for example, with plant products,
12 the homeopathic dilution starts with a mother
13 tincture, which is an herbal tincture that will
14 have pharmacologic levels of an herb in it. That
15 is then diluted into -- diluted many times -- but
16 the mother tincture is still considered a
17 homeopathic product.
18 So, apparently zinc and other compounds
19 can be considered a homeopathic product, even if
20 it has not yet been richly diluted.
21 MR. PACE: You spoke a little bit about
22 the differences in high and low potency
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1 homeopathic products. Can you comment on a
2 potential distinction in policy between the low
3 and high potency products? I mean, do you think
4 there should be one?
5 MS. FUGH-BERMAN: Well, in classical
6 homeopathy, where you're fitting somebody's
7 symptoms and personality, if you will, onto a
8 specific high potency homeopathic product that may
9 be even prescribed by a prescription from somebody
10 who's trained in this, there does not seem to be a
11 safety concern with those individual products.
12 So that's an interesting idea, making a
13 distinction between them. So the high potency,
14 more dilute products would be less likely to cause
15 problems. But I think that really they should all
16 be labeled.
17 If it's a high potency product, you
18 know, we can say, "This product has less than .01
19 nannograms" of a particular ingredient in it.
20 DR. BENT: Could you comment a little
21 on the variability of the pharmacologically active
22 substances in low dilution products?
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1 MS. FUGH-BERMAN: The variability of
2 what?
3 DR. BENT: The variability of the
4 pharmacologically active substance in the highly -
5 - or in the high and the low dilution products.
6 MS. FUGH-BERMAN: So if a product is 1x,
7 that means it's been diluted ten times once. If
8 it's 3x, it's been diluted three times. If it's
9 3c, it means it's been diluted a hundred times,
10 three times, so it's a hundred to the third.
11 So, by the time you've diluted something
12 30 times, even in a one to ten, the chances -- you
13 might be below Avogadro's number at that point, so
14 you probably won't have any molecules of the
15 original substance left in it.
16 MR. PACE: And when you speak about
17 listing quantity, would those products essentially
18 list zero?
19 MS. FUGH-BERMAN: Well, there certainly
20 should be a designation that is, you know, less
21 than -- less than .01 nannograms, or something
22 like that. Yeah. I think it would -- because it
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1 would be difficult to -- it would be difficult,
2 you know, to test it for exactly how much was in
3 it, but if it's a high dilution, it should say,
4 less than some very, very tiny number.
5 I think that would give more information
6 to consumers, and also healthcare providers.
7 Thank you.
8 DR. WHYTE: Okay. Next we will turn to
9 Michael DeDora from the Center for Inquiry -- or
10 is it Inquiry?
11 MR. DeDORA: Thank you. I speak today
12 as Director of Public Policy for the Center for
13 Inquiry, an educational and advocacy organization
14 that promotes reason and science in public
15 affairs.
16 My testimony, however, is not on behalf
17 of only our organization, its employees, and its
18 members, but also on behalf of dozens of doctors
19 and scientists associated with CFI and its
20 affiliate program, the Committee for Skeptical
21 Inquiry with whom we work on these matters.
22 Neither I nor the Center for Inquiry has any
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1 financial interest relevant to these matters.
2 We applaud the Food and Drug
3 Administration for holding this important meeting.
4 Given the tremendous growth in the sale of
5 homeopathic products in recent decades, a
6 reassessment of the FDA's regulation of these
7 products is clearly warranted.
8 Our goal is to briefly review the
9 scientific evidence that shows homeopathy is an
10 ineffective method to treat illnesses, illustrate
11 the harm caused by reliance on homeopathy instead
12 of actual medicine, and to propose actions the FDA
13 should take to hold homeopathic products to the
14 same standards as non homeopathic drugs in order
15 to fulfill its mandate to protect the American
16 public.
17 We could spend hours discussing the
18 extensive, decades long, scientific examination of
19 homeopathy, but suffice it to say, the empirical
20 evidence against homeopathy is overwhelming.
21 Aside from the placebo effect,
22 homeopathic products have no effect in treating
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1 illnesses.
2 Consider, for example, the most recent
3 findings released last month by the Australian
4 National Health and Medical Research Council.
5 This group conducted a meta study thoroughly
6 assessing more than 1,800 papers on homeopathy,
7 225 of which met the criteria for inclusion.
8 They conclude that, "There are no health
9 conditions for which there is reliable evidence
10 that homeopathy is effective."
11 Of course, this makes sense. By its own
12 definition, homeopathy cannot work. It's
13 centuries old principals sit at complete odds with
14 our modern understanding of biology, chemistry,
15 and physics -- the bodies of accepted knowledge
16 that form the basis of modern medicine.
17 Again, we need not spend much time on
18 this, as the federal government is well aware of
19 the scientific evidence against homeopathy.
20 As the National Center for Complimentary
21 and Integrative Medicine states on its website,
22 "There is little evidence to support homeopathy as
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1 an effective treatment for any specific
2 condition."
3 Furthermore, the FDA itself has
4 recognized that homeopathy is not effective
5 through its varies consumer warnings about the
6 health risks of relying on homeopathic products to
7 treat medical conditions. This includes the FDA's
8 March 19, 2015 warning against using homeopathic
9 products that claim to treat asthma, an often life
10 threatening condition.
11 Despite substantial empirical evidence
12 to the contrary, companies persist in marketing
13 ineffective homeopathic products as drugs that can
14 effectively treat illnesses, and consumers
15 continue to spend upwards of billions of dollars
16 each year believing that they will be helped. And
17 worse, even if these products might not be
18 effective, they are at the very least not harmful.
19 This should deeply concern the Agency
20 charged with protecting public health, especially
21 as the problem is in part caused by set Agency's
22 failure to regulate homeopathic products. Despite
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1 what many consumers believe, homeopathic products
2 can directly cause harm. Sadly, children often
3 bear the brunt of this harm.
4 For instance, in its 2012 report, the
5 American Association of Poison Control Centers
6 noted that there were a whopping 10,311 reported
7 cases of exposure related to homeopathic agents,
8 with 8,788 of those reported cases attributed to
9 children five years of age or younger. Of those
10 cases, 697 required treatment in a healthcare
11 facility.
12 Still, perhaps the greatest harm caused
13 by homeopathy is not necessarily caused by the
14 products themselves, which when properly prepared
15 rarely contain anything other than water and
16 inactive ingredients, such as sugars and binding
17 agents, but by the fact that people often rely on
18 homeopathic products to the exclusion of proven
19 scientific remedies.
20 As the Australian study states, "People
21 who choose homeopathy may put their health at risk
22 if they reject or delay treatments for which there
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1 is good evidence for safety and effectiveness."
2 The website "What's The Harm" details
3 many such cases. I will highlight just a few.
4 Lucille Craven of New Hampshire was diagnosed in
5 1997 with a small pea sized carcinomas breast
6 tumor. Although her doctor recommended
7 mastectomy and lumpectomy, Lucille treated her
8 cancer with homeopathy. She died less than 36
9 months later.
10 Diane Picha (ph) of Wisconsin was
11 diagnosed in late 1998 with lung cancer. After
12 successful surgery to remove her tumor, her cancer
13 grew back. Picha (ph) visited a homeopathic
14 clinic where she was advised to halt further
15 treatments. She died in April 2000.
16 Katie Ross of Nevada was diagnosed with
17 ulcerative colitis. Doctors recommended that she
18 have her colon removed. However, her mother
19 pursued homeopathic treatments. Katie dwindled
20 from 90 to 50 pounds and nearly died when her
21 colon perforated, but survived when her mother
22 finally approved surgery at the doctor's pleading.
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1 Lastly, Isabella Dinley (ph) of
2 Melbourne, Australia, was an epileptic toddler
3 prescribed anti-convulsent medication by her
4 Neurologist. Her parents, however, treated her
5 exclusively with homeopathic products. She died
6 at just 13 months old.
7 These examples clearly illustrate the
8 public's lack of knowledge regarding homeopathy,
9 the danger of homeopathic products, and thus, the
10 need for the FDA to take an active approach in
11 promoting accurate knowledge on homeopathy.
12 Proponents of homeopathy often argue
13 that homeopathic products should be available
14 because individuals have the right to freedom of
15 choice. We fully support the right to freedom of
16 choice, however, we also believe that true freedom
17 of choice is impossible unless one is fully
18 informed on the choices.
19 In fact, this is one of the fundamental
20 principles justifying FDA regulation. The public
21 needs the guidance of an expert agency when it
22 comes to buying drugs.
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1 Accordingly, we propose that the FDA
2 announce and implement strict guidelines that
3 require all homeopathic products to meet the same
4 standards as non homeopathic drugs.
5 In particular, we suggest the FDA take
6 three steps. One, testing for homeopathic
7 products -- as the FDA recognizes, the Federal
8 Food, Drug, and Cosmetic Act does not exempt
9 homeopathic products from meeting the same
10 standards of safety and efficacy as non
11 homeopathic drugs, nor does this Act prevent the
12 FDA from enforcing these standards.
13 In order to protect the public health,
14 we urge the FDA to mandate that all homeopathic
15 products on the market pass safety and efficacy
16 tests equivalent to those required of non
17 homeopathic drugs on the market.
18 Two, labeling for homeopathic products.
19 Labeling on homeopathic products needs to improve.
20 This is especially true if the FDA does not
21 require that they be tested for safety and
22 efficacy, as this would allow dangerous
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1 homeopathic products to remain on the market
2 without warning, marketed to a public that is
3 unaware homeopathic products are different in kind
4 from non homeopathic drugs.
5 Currently, many homeopathic products
6 boast that they are regulated by the FDA without
7 explaining that they are not subject to testing.
8 This is seriously misleading.
9 We, therefore, urge the FDA to ensure
10 that all homeopathic products prominently state
11 two things. One, the products claimed active
12 ingredients, in plain English, and two, that the
13 product has not been evaluated by the FDA for
14 either safety of effectiveness.
15 Third, regular consumer warnings. We've
16 been encouraged by the FDA's recent announcements
17 warning consumers that homeopathic products will
18 not treat their illnesses.
19 Given the lack of public knowledge on
20 homeopathy, we urge the FDA to continue making
21 such announcements on a regular basis, especially,
22 but not only, during times of illness outbreaks
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1 and public health crises.
2 In summary, homeopathy is unsupported by
3 scientific evidence, ineffective in treating
4 illnesses, and when relied upon instead of actual
5 medicine, dangerous and even deadly.
6 To ensure the protection of the American
7 public, the FDA should rely on its well
8 established regulatory system to require
9 homeopathic products to meet the same standards as
10 non homeopathic drugs, or at the least, mandate
11 labeling for homeopathic products which states the
12 products claimed active ingredients in plain
13 English, that the product has not been evaluated
14 by the FDA for safety or effectiveness.
15 The American public deserves as much
16 from the Agency tasked in protecting them. Thank
17 you.
18 DR. WHYTE: All right. We can reset the
19 timer for five minutes, and if we have any
20 questions for Mr. DeDora from the Center for
21 Inquiry?
22 MS. LIPPMANN: Yes. Do you have any
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1 data or information you can share with us about
2 the effectiveness of disclaimers in ensuring
3 consumer understanding generally and how that
4 might relate to homeopathic products?
5 MR. DeDORA: I think that's a fantastic
6 question. I don't have any data that I can think
7 of off the top of my head, but if it exists we
8 will be sure to include it in our written comments
9 that will be submitted later.
10 MS. LIPPMANN: Please do. Thanks.
11 MR. DeDORA: Thank you.
12 DR. LOSTRITTO: Hi. I was just
13 wondering if the Center for Inquiry, along the
14 commission of, you know, scientific elucidation,
15 has looked at the manufacturing methods or the
16 ingredient quality that's typically used in these
17 products, or if not?
18 MR. DeDORA: We, through our magazine,
19 Skeptical Inquirer, have done a number of reports
20 by doctors and scientists regarding the process by
21 which homeopathic products are made.
22 I think some of the comments that were
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1 made in the remarks before me highlighted that
2 problematically sometimes some things can get into
3 these products that shouldn't be in there and can
4 cause some health risks.
5 I'm not, unfortunately, well versed on
6 that specific area -- on this topic though -- and
7 again, it's something that I think we could
8 follow- up in our lengthier written comments.
9 MS. MICHELE: You commented that you are
10 requesting that all homeopathic products on the
11 market pass safety and effectiveness testing
12 equivalent to those required for non homeopathic
13 drugs.
14 So are you proposing that these products
15 be required to be tested, but still marketed under
16 enforcement discretion, such that the FDA would
17 not review those tests? Or are you proposing that
18 all of these products would come in under a new
19 drug application, as with other over the counter
20 and RX products that are not subject to the OTC
21 monogram?
22 MR. DeDORA: If I understand your
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1 question correctly, the way that we read the Food,
2 Drug, and Cosmetic Act is that currently the FDA
3 does have the authority to require homeopathic
4 products to pass the same tests as other non
5 homeopathic drugs on the market.
6 So, we're not sure that there needs to
7 be new legislative or other authority taken by the
8 Agency. I'm not sure if that's what your question
9 was about though.
10 MS. MICHELE: No, that's actually not
11 what I'm asking. So, you're asking about this
12 type of testing -- so are you suggesting that
13 these should fall under the same new drug
14 application regulatory pathway as other drug
15 products?
16 MR. DeDORA: Yes. Thank you.
17 DR. WHYTE: Okay. With that we will now
18 turn to Wayne B. Jonas, the President and CEO of
19 Samueli Institute. Did I say that correctly?
20 MR. JONAS: Yes.
21 DR. WHYTE: Okay.
22 MR. JONAS: Good morning. How are you?
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1 I think I'm the bridge here.
2 Thank you very much for having me and
3 giving me a few minutes to summarize the evidence
4 for homeopathy. I'm not going to talk about
5 labeling, but I'm really going to address what
6 research do we know? What does it mean? Where
7 are we in the state of research around homeopathy
8 -- identify some of the gaps, and hopefully shine
9 a light on why there is so much controversy around
10 these areas, and is there any evidence that there
11 should be controversy in those areas.
12 So, I am a physician and I run an
13 organization called the Samueli Institute. It's a
14 nonprofit, independently funded, research
15 organization.
16 We're interested in a variety of aspects
17 of non pharmacological approaches to healing, and
18 do research from basic science all the way up to
19 health services research, and I have no conflicts
20 of interest in this. We're not funded by any
21 company of any type, nor am I an expert witness
22 for anybody.
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1 So, I'm a family physician -- 35 years -
2 - 24 years of that in the military. During that
3 time I directed the Medical Research Fellowship at
4 Walter Reed Army Institute of Research, where I
5 taught research methods to physicians, and we
6 continue to do that at Samueli Institute as well
7 as other healthcare practitioners.
8 I also ran the NIH Office of Alternative
9 Medicine and homeopathy was one of the several
10 hundred types of practices we were charged with
11 trying to sort out the truth from the falsities,
12 and come up with the diversity of research methods
13 necessary.
14 I ran the WHO Traditional Medicine
15 Center, and I'm also currently a Professor of
16 Family Medicine at Georgetown and at the Uniform
17 Services University.
18 So I got interested in homeopathy when I
19 was running a clinic in Germany as a military
20 physician, and the German physicians that I had to
21 work with for our emergency transport were using
22 homeopathy regularly and claiming that it worked
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1 quite well, and that they could integrate it with
2 their conventional care.
3 So I became very curious about that,
4 especially since it didn't look like there was
5 anything in them, and began to try it out in my
6 own practice and then subsequently try to look at
7 the research to see what evidence there was in
8 those areas.
9 So, I and my colleagues, German
10 colleagues and others, published the first med
11 analysis, clinical med analysis, of homeopathy in
12 the Lancet in 1997, and we also published the
13 first laboratory med analysis of homeopathy in
14 1994, and then subsequently published the first
15 attempt to sort of look at the specific
16 indications and what evidence do we have around
17 its usefulness in particular clinical conditions
18 in the Anals (ph) of Internal Medicine in 2003.
19 When I retired from the military in 2001
20 and started the Samueli Institute, we continued to
21 work -- about half of our time is with DODVA (ph)
22 and other university labs. We do all of our
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1 research by finding the best quality scientists
2 around the world and then trying to set up teams,
3 and then funding those projects to make sure that
4 they're done rigorously.
5 We currently have several projects in
6 the field of homeopathy. We focus mostly on
7 laboratory research because that sort of gets at
8 this issue of the ingredient and the placebo
9 issue. So animal models, cell models, this type
10 of thing, and now have ongoing programs looking at
11 brain injury in laboratory and cell models,
12 defense agents, cancer, viral infection, and
13 environmental toxicology.
14 I won't have time to go over that
15 research with you, but it is available if -- and
16 most of it is published in journals if you'd like
17 to see them.
18 But let me just make a comment about
19 what research quality is. Good research is when
20 you match the question and the people that are
21 going to use the information that you get out of
22 the research, with high quality methodologies.
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1 And so there's no one single methodology
2 that is superior to all others. You have to match
3 it with a question. You have to know who is going
4 to use it.
5 So you have to first ask the question,
6 and this is the Methods Mandala that I've used for
7 years in teaching research methods to folks, and
8 it starts -- and if you look in the ring -- let's
9 see, right in the middle there -- those are the
10 sort of main questions that people ask.
11 What is it and how is it applied?
12 What's the current evidence for it? What impact
13 is it having in a particular session? How does it
14 work? Is it safe and effective? What does it
15 cost? How does it compare to other systems? Very
16 important recently with comparative effective
17 research that's gotten popular -- and then how can
18 it be translated to other practices?
19 These are the fundamental questions that
20 primarily biomedical research asks, and around the
21 outside ring are examples of methodologies that
22 are used to try to get that information.
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1 And so when you look -- when you talk
2 about high quality, it's important to make sure
3 you know you're using the right method for the
4 right question.
5 As illustrated by this cartoon, "You
6 know it's wrong -- maybe it's just unorthodox,"
7 you don't use unorthodox methodologies to get at
8 the truth. You have to use good science in these
9 areas. But those who don't know science, who are
10 not very well educated in this kind of
11 methodology, often misapply methodologies to try
12 to make statements that weren't meant to answer
13 the question in the beginning. And so this is
14 kind of category error is something that you have
15 to pay attention to.
16 So, in any of these methods you try to
17 get at something called validity, which is --
18 there's a variety of types of that. Here's an
19 example of different types of validity:
20 Internal validity, which is trying to
21 get at the efficacy question. Is the effect
22 actually due to what you think it is, your
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1 hypothesis? External validity, which is looking
2 at, you know, is this something that's real and
3 replicable out in the real world? Model validity,
4 which is, have you actually applied the approach
5 the way it adequately -- in order to actually test
6 it adequately?
7 There's other types of validity, but
8 they all are focused on trying to reduce bias and
9 improve our judgment management. It doesn't do
10 too much good to do a very rigorous study and then
11 just have someone dismiss it without actually
12 looking at the methods in those areas, which
13 unfortunately is what happens too often.
14 So, if we take these research standards
15 and then we just sort of do a broad brush of the
16 current research in homeopathy, the approaches
17 that one can look at for some of these questions
18 are systematic reviews and randomized controlled
19 trials for looking at efficacy, longitudinal
20 outcomes research for getting at effectiveness,
21 and laboratory research for getting at mechanisms
22 in those areas.
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1 In all of these cases, as I've
2 illustrated, it's very important to minimize bias,
3 and the bias reduction techniques that have been
4 developed over the last ten to -- ten years,
5 especially -- have markedly improved, but
6 unfortunately, most people don't apply that.
7 And we have developed and systematized,
8 and streamlined some of these systems. We call
9 them REAL and SEARCH processes -- applied a lot of
10 these to controversial areas to try to sort out
11 the wheat from the chaff.
12 We also use things like the GRADE
13 analysis and work closely with the Rand
14 Corporation. We actually have a chair and a
15 program, a joint program, at Rand in Santa Monica,
16 which looks at management of judgment issues
17 around science using approaches called
18 "appropriateness," which goes into the next step
19 in terms of looking at -- once you have the
20 evidence, how do you make determinations of what's
21 an appropriate practice and what's not? And
22 that's a whole process for doing that.
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1 So, I want to step back and do a -- talk
2 about meta-analyses (ph,) because it's a little --
3 it's instructive in terms of what's happened over
4 the last several decades.
5 This is the title of the Lancet med-
6 analysis that we published in 1997, and I'd just
7 point out that it did involve experts from the
8 Cochrane Collaboration, now -- more well known now
9 than it was back then -- and also Larry Hedges.
10 Larry Hedges is a Professor at the
11 University of Chicago, who literally wrote the
12 book on meta-analyses. It has all kind of really
13 interesting techniques for trying to find out if
14 your own methods that you're using are biased,
15 because sometimes those are hidden.
16 So, that meta-analyses took 98 studies at
17 that time in homeopathy, clinical trials,
18 randomized placebo control trials, and did a whole
19 series of attempts at getting at, you know, could
20 you get rid of the effect, if you saw an effect,
21 beyond placebo, in those areas?
22 And so we did a whole series of
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1 sensitivity analyses, including the high quality
2 components. We did something called the "worst
3 case" which is like applying all of the quality
4 components one could ever come up with to those
5 areas, and then we did subgroup analyses for
6 different types of homeopathy.
7 And this graph actually illustrates in a
8 single thing what we found. If it's on that side,
9 it favored homeopathy. If it's on this side it
10 favored placebo. And as you can see, the vast
11 majority of these things seemed to favor
12 homeopathy.
13 We had tried to eliminate that effect,
14 but we couldn't. We got close. We actually got
15 very close, so we said, "Well, maybe it just is
16 because of what's in the literature." There's
17 something called publication bias.
18 We know in meta-analyses positive studies
19 tend to get published more often than negative
20 studies, and so maybe that's what was going on.
21 So we did a funnel plot like this, and
22 we found out at that time that indeed positive
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1 studies were more in the literature than the
2 negative studies, and it looked like there was a
3 file drawer effect, that some of the negative
4 studies were just shuffled off.
5 Now, since this, it's been shown that
6 there's also reverse discrimination against
7 homeopathy, where positive studies tend not to get
8 in the top peer review journals that everybody
9 looks for, and that's been systematically
10 demonstrated by sending out peer review, changing
11 the labels, and finding out if you call it
12 homeopathy, the top journals won't publish it.
13 We sent our meta-analyses to many, many,
14 top journals before we could get it published in
15 the Lancet and it's still a problem in those
16 areas.
17 But Larry Hedges came up with a very
18 ingenious approach, which at that time was novel.
19 He said, "Well, what if you could estimate the
20 effects of the negative studies that were out
21 there somewhere, or might be out there some time
22 in the future, that would be required to eliminate
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1 this effect?"
2 And so we did something called the "trim
3 and fill." You can do this mathematically. This
4 is a graphical illustration of that, and if you
5 did have no publication bias in these areas -- and
6 you could set different sensitivities for that --
7 could you eliminate this effect? We could get it
8 almost to zero, but we couldn't quite eliminate
9 it.
10 But, the lesson that we learned from
11 this, that we said in the article -- and we made a
12 prediction actually -- that all subsequent
13 systematic reviews, if they're attempting to
14 answer the large question of whether homeopathy
15 works or not, you're not going to be able to
16 answer it.
17 All it's going to be is just one
18 selection bias after another, depending upon what
19 studies you pick out to put in your study, and we
20 showed that mathematically. We estimated there
21 was not nearly enough investment in research in
22 homeopathy to ever, ever answer that question in
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1 the next 100 years, unless a marked amounts of
2 money, more money, went into research in those
3 particular areas.
4 And so, if you look at the last couple
5 of decades of systematic reviews in these areas,
6 this is exactly what you see. These are the major
7 systematic reviews or meta-analyses done from 1991
8 until the Australian one, which was mentioned
9 already a couple of times this morning.
10 And, as you can see, it's exactly that.
11 One picks certain studies and says, gee, it's
12 positive, the other picks other studies, and says,
13 gee, it's negative, and you just sort of alternate
14 back and forth in these areas.
15 The latest one doesn't necessarily mean
16 it's the best one. In fact, the Australian study
17 was very poorly done if you use standard
18 systematic approach processes in those areas.
19 It's not the best study that's out there.
20 But this simply illustrates the
21 prediction that we made in 1997 around those
22 areas, that you can't answer that question. It's
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1 almost like saying, "Well, gee, does surgery
2 work?" Okay? So we'd have to look at all studies
3 of surgery and, you know, put them together.
4 You've got to be more discriminatory on
5 that and that means you have to select out
6 specific treatments for specific conditions, and
7 then do the kind of meta-analyses that you're
8 looking for around those treatments.
9 Here's one that actually was not
10 mentioned in the Australian study. In fact, they
11 missed three systematic reviews even though they
12 claimed to have everything in those areas. But it
13 shows you an example in a specific condition, like
14 arthritis, what the current state of the evidence
15 is around the efficacy of homeopathy.
16 We attempted to do this in an Annuals of
17 Internal Medicine article. That was in 2003. It
18 needs to be updated. My best guess, and this has
19 not been updated so don't take any of the fault --
20 the next slide is the gold standard -- is that
21 right now the current evidence seems to indicate
22 that there are a variety of things, if you use
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1 standard meta-analyses approaches, looking at two
2 or more randomized controlled placebo trails, that
3 it is effective for certain conditions, and using
4 the same criteria, that it's ineffective -- on the
5 right hand side.
6 I think if the FDA did anything, they
7 ought to actually invest in doing good assessment
8 of this literature using those kinds of --
9 investing and trying to sort out what we know.
10 Now, there's always the question of
11 replicability, and this is the problem. You do
12 studies over and over again, and they don't always
13 replicate itself.
14 Let me put that in context. Over the
15 last two years there's been a lot of discussions
16 about replicability, and it's not as easy as it
17 looks. Nature and JAMA (ph) both have published
18 extensive studies on that. John Iunodis (ph) from
19 Stanford University is probably the primary
20 scientist who's looked into these areas and he's
21 shown that even established studies, drug studies,
22 over 40% of them cannot be replicated. These are,
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1 again, peer reviewed publications.
2 We know in drug studies of
3 antidepressants, for example, it's very difficult
4 to show replication over a placebo, which is why
5 we spend hundreds of millions of dollars trying to
6 get them approved and show that they actually work
7 better than placebo in those areas. Psychological
8 and behavioral sciences are worse.
9 So, given my time is running down here,
10 I'm going to talk a little bit about a comparative
11 effective research, which is a recent area that's
12 gotten attention. This allows whole systems to be
13 compared and it allows observational studies or
14 randomized studies to be used in those areas.
15 Here's the best long-term observational
16 study of homeopathy. It doesn't look at the
17 specific effects or the mechanistic effects in
18 those areas, but it does show overall, in over
19 3,000 patients, that if you go see a homephath,
20 regardless of what they're doing, you know, you
21 seem to get better, and that improvement seems to
22 persist in those areas.
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1 The argument -- my last slide -- the
2 argument that you hear around the controversy is
3 because different people have different
4 hypotheses. The placebo hypothesis is what the
5 skeptics purport, and the other mechanisms that
6 are listed underneath here are ones that the
7 advocates support. There's very little data for
8 either of these hypothesis that isn't different
9 than what goes on in those areas.
10 So, I hope the FDA will actually do what
11 we just did for the DOD, and do a comprehensive,
12 systematic assessment of homeopathy for the
13 current evidence in these areas. We just
14 published this in Pain Medicine, looking at
15 integrative and non- pharmacological approaches to
16 pain. We're doing the same with the Rand
17 Corporation in Chiropractic right now, and that
18 kind of approach should be taken in homeopathy.
19 So, thank you.
20 DR. WHYTE: Thank you. And let's reset
21 the timer. You'll have five minutes for
22 questions.
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1 MR. LOSTIRITTO: Hi. Very comprehensive
2 overview. I would ask you if you know if any of
3 these studies looked at the use of homeopathy in
4 conjunction with what would be considered more
5 conventional therapy, and any change in outcomes
6 from that?
7 MR. JONAS: Yeah. A number of those --
8 a number of them have. I didn't have a chance to
9 show sort of the equivalent studies where they
10 were looking at homeopathy compared to, let's say,
11 an established, on the market, OTC. There's been
12 examples of that, for example, for vertigo and
13 other things.
14 Again, there's even fewer studies in
15 that area than there are -- and equivalent studies
16 require very special power calculations to
17 actually show that they are equivalent. Most of
18 the studies in those areas have shown that the
19 homeopathic remedy has about equivalent to the
20 standard drug in those areas.
21 A recent one came out on depression that
22 actually added a placebo arm to that, which then
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1 allows you to distinguish both of those. Very few
2 studies do that. Mostly they do that -- and if
3 all of them are getting improvement from the
4 placebo effect, then you don't know. Is it -- you
5 know, you just know that they're equal.
6 In comparative effectiveness research
7 they do quite a bit of that. I think you need to
8 actually add on treatment as usual, and/or a
9 placebo, in order to distinguish between those.
10 In comparative effectiveness research,
11 because of this phenomenon, they're going more and
12 more to costs, and saying, "Well, how much -- how
13 difficult is it to deliver and what does it cost,
14 and what are the side effects?" rather than trying
15 to answer the equivalence -- that equivalence
16 side. So I don't know if that answers your
17 question or not, but --
18 DR. IZEM: I have a question about your
19 main systematic reviews in meta-analyses that you
20 listed in one of your slides.
21 MR. JONAS: Yeah.
22 DR. IZEM: I was wondering, did these
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1 different meta-analyses include the same set of
2 trials? Were they starting from the same set of
3 trials? And if yes, were the differences that were
4 observed in the different meta-analyses just driven
5 by different methodologies that were used?
6 MR. JONAS: So over the years there has
7 been a gradual increase in the number of studies
8 published, and so the ones in 1997 did not include
9 all the same ones in 2014, although usually they
10 try to build on themselves, so they did try to
11 capture what was there before, and so you got
12 incremental growth in those areas. Not always,
13 sometimes there was -- they didn't capture them
14 all.
15 The methodologies were not the same. In
16 fact, the selection criteria -- for example, in
17 the Australia study -- very different than what
18 was done in most meta-analyses, where they went in
19 and actually picked out what they considered the
20 top meta-analyses and then used their quality
21 assessments to make judgments, for example.
22 Most meta-analyses do an independent
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1 quality assessment of that area, so there's an
2 example of two different kinds of methods that
3 were used. So the answer is, they don't use the
4 same method.
5 DR. IZEM: And some of the meta-analyses
6 that you mentioned put information from different
7 indications together, and also, was that true for
8 all of the systematic meta-analyses, or did they
9 restrict themselves to particular indications?
10 MR. JONAS: Most of them -- well, the
11 larger ones tried to catch -- who are trying to
12 answer the big question of homeopathy -- would try
13 to capture and then sub analyze the individual
14 ones.
15 Some of the meta-analyses preselected the
16 conditions they were looking at and then only
17 looked for studies in those areas, so they had a
18 much smaller subset of conditions.
19 DR. IZEM: So one last question.
20 MR. JONAS: Uh-huh?
21 DR. IZEM: Is it -- was most of the
22 homeopathic trials -- were they putting together
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1 OTC as well as prescription, or was it all
2 prescription?
3 MR. JONAS: So, the prescription varies
4 depending upon what country you're in, and so
5 there was no distinction in most of these as to
6 whether they were OCT or prescription items. They
7 were just lumping them together based on
8 indications and based on condition.
9 DR. NELSON: I think you rightly point
10 out some of the difficulties in meta-analyses, but
11 let me ask, what data would you then argue ought
12 to be brought to bear on showing the safety and
13 effectiveness of homeopathic products for specific
14 conditions?
15 MR. JONAS: Well, I think -- you know,
16 we run systematic reviews all the time for
17 different groups, and the first thing we do is we
18 sit down and try to define, what question is it
19 that the sponsor or the client wants to answer?
20 And out of that, then you can go through
21 a set of selection criteria that will get at that
22 particular question. You have to do that first.
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1 That allows you to determine what data
2 should be done, and then you have to do the bias
3 reduction approaches that I'm talking about. So
4 you have to apply bias reduction components on
5 those.
6 DR. NELSON: Let me follow-up with a
7 clarity question. I was asking what data ought to
8 be brought forward to show efficacy? That's the
9 question, and not what data one can get out of the
10 literature based on bias reduction of studies that
11 have already been performed.
12 MR. JONAS: I think if you're going to
13 try to show efficacy, and you're trying to test
14 whether the component within a homeopathic remedy
15 - - that's assuming one can figure out what that
16 is - - then you have to do -- I mean, we have a
17 gold standard for that. That's the randomized,
18 double blind, placebo controlled trial,
19 replicated, multi- center, preferably, if the
20 question is efficacy of the particular component
21 of the product.
22 If you're trying to get a comparative
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1 effectiveness -- a question that was asked before
2 about, you know, how does this work compared to
3 some other system of medicine? Because homeopathy
4 is a whole system. It's not just a remedy.
5 Then, I think the gold standard is to do
6 also randomization because you can then start at
7 the same finish line, but you can't do it -- you
8 can't really do placebo very easily in that if
9 you're doing very, very different systems. If
10 they're both drug systems, you can put in double
11 dummy and other kinds of things to try to get at
12 that in those areas.
13 So, if you're trying to get at
14 effectiveness, what happens when you put it out
15 into practice? I showed you the study that I
16 think is the kind of gold standard for that.
17 That's longitudinal, observational, large-scale,
18 big data at observational trials.
19 DR. NELSON: Thank you.
20 MR. JONAS: Uh-huh.
21 DR. WHYTE: So I do know they are having
22 a few issues with sound on the webcast -- not from
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1 the speakers -- but I asked my colleagues that are
2 the panelists -- I think what's happening is when
3 you're asking your questions you're being very
4 gentile and turning to the panelist, and actually
5 turning your face away from the mic, and I think
6 that's causing some of the issues in terms of the
7 sound.
8 So, if you could either talk straight
9 into the mic with your question and then turn, I
10 don't think anyone will get offended on the panel,
11 because they do want folks that are watching it
12 being able to hear the questions and the
13 discussion.
14 We do have one more speaker before
15 lunch. That is Lisa Amerine from the Homeopathic
16 Academy of Naturopathic Physicians.
17 DR. AMERINE: One more before break.
18 Thank you for the opportunity to speak today at
19 this public hearing. My name is Dr. Lisa Amerine.
20 I'm a Naturopathic Physician, and am board
21 certified by the Homeopathic Academy of
22 Naturopathic Physicians, with Diplomat status in
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1 homeopathy.
2 Since a very young age my life has been
3 committed to homeopathy, being raised using that,
4 and for the past 11 years I've maintained a highly
5 successful practice exclusively in homeopathy in
6 Lafayette, Colorado.
7 Currently, I also sit on the board for
8 the HANP. I am the HANP House of Delegates
9 representation for the American Association of
10 Naturopathic Physicians, in which I represent the
11 specialty field of homeopathy.
12 I am also a co-leader on what is known
13 as the Materia Medica Pura Project, a collective
14 30,000 plus hour project, with the purpose of
15 collecting any existing literature on homeopathic
16 medicine.
17 This literature includes proving
18 publications, toxicology reports, and cured cases,
19 for every homeopathic medicine. This information
20 is then compiled into one document known as the
21 Materia Medica Pura, and serves as the most up to
22 date information for homeopathic medicines. This
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1 ongoing project ensures there is up to date and
2 correctly referenced literature on every
3 homeopathic medicine.
4 The Homeopathic Academy of Naturopathic
5 Physicians is a specialty field recognized within
6 Naturopathic medicine. Naturopathic physicians
7 lead our community throughout the U.S. in natural
8 healthcare.
9 Physicians who specialize in homeopathy
10 go over and beyond the already vigorous training
11 received in homeopathy at naturopathic schools, by
12 undergoing further training in homeopathy. Upon
13 completion of this process, which includes an
14 additional board examination, they are awarded a
15 diplomat status.
16 Practicing homeopathy is a true
17 specialty in medicine and a diplomat status
18 recognition rewards and acknowledges physicians
19 who have worked to achieve this status, setting
20 them apart from any others who may be practicing
21 homeopathy, thus naturopathic physicians with
22 diplomat status in homeopathy are among the
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1 leading experts in the United States of
2 homeopathy.
3 The HANP also serves to further the
4 excellence and success of homeopathy by providing
5 continuing education to further sharpen the skills
6 of not only diplomats, but of other physicians
7 interested in homeopathy.
8 We are also committed to being an
9 education resource for general healthcare
10 providers and the general public who may have
11 questions regarding homeopathy.
12 So, the HANP would like to respond to
13 three particular questions posed by the FDA. The
14 first one is the question of the consumer health
15 care provider attitudes towards human drug and
16 biological products labeled as homeopathy.
17 The licensed homeopathic medical
18 professions have a vast knowledge of the Materia
19 Medica, which list the properties of medicines we
20 use.
21 This literature, when employed in
22 conjunction with consideration of the unique
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1 totality of symptoms with which a patient
2 presents, forms the basis for the accurate
3 prescription of homeopathic medicines. Well
4 trained homeopaths will only prescribe based on
5 these principals.
6 Therefore, medicines labeled as
7 homeopathic, regardless of their source, including
8 human drug and biological products, will not be
9 prescribed unless there's proper literature found
10 in the monographs to support the prescription.
11 The homeopathic healthcare
12 professionals, especially those with diplomat
13 status, have very, very busy practices.
14 Frequently, we will train our patients regarding
15 homeopathic medicines that they can purchase over
16 the counter to take care of simple, non dangerous
17 conditions, such as an acute cold.
18 The consumers love this because they can
19 try some basic things at home that are often very
20 effective, very safe, and inexpensive to use. The
21 healthcare provider likes this because it empowers
22 the patient and leaves time for the physician to
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1 treat more serious health conditions.
2 The next question is current areas --
3 are there areas of the current CPG that could
4 benefit from additional clarity? The HANP serves
5 to further the excellence of homeopathy by
6 providing a resource and continuing education for
7 providers in the community.
8 In an attempt to further the excellence
9 in homeopathy, the HANP believes that the FDA's
10 documentation, conditions under which homeopathic
11 drugs may be marketed, does need some
12 clarification.
13 For example, definition number two
14 states, "Drug products containing ingredients in
15 combination with non homeopathic active
16 ingredients are not homeopathic drug products."
17 While this definition is clear, there's
18 a loophole that many products are taking advantage
19 of. This loophole provides manufacturers the
20 opportunity to put a substance in the inactive
21 category list that would -- leaving the active
22 category list as HPUS (ph) homeopathic remedies
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1 that clearly meets the definition.
2 These inactive ingredients are not
3 always stabilizers, but often a dietary supplement
4 or herb, for example, such as tea tree oil or Aloe
5 Vera. This allows manufacturers to put products
6 on the market and make an OTC drug claim when
7 otherwise their product would be limited to a
8 dietary supplement status.
9 When this is done, the product should
10 not be considered a homeopathic drug, nor should
11 they be allowed to be marketed as such. The HANP
12 believes this is a good example of where
13 additional clarification would be helpful.
14 The last question, do consumers and
15 healthcare providers have adequate information to
16 make informed decisions about drug products
17 labeled as homeopathic?
18 The Homeopathic Academy of Naturopathic
19 Physicians serves to provide quality education,
20 not only to other healthcare professionals, but
21 also to the lay public. Physicians, in particular
22 those with diplomat status, are in the front lines
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1 of homeopathic healthcare, and daily field
2 questions from the consumer and from other
3 healthcare providers regarding homeopathic
4 products.
5 Every week I get people call us about a
6 product. What do you think about this? Is this
7 product safe? What can you tell me about this
8 product?
9 These experts, because of our knowledge
10 - - the extensive knowledge in homeopathy -- we
11 can easily provide information regarding products
12 which are labeled as homeopathic, and comment
13 knowledgeably as to the efficacy and safety.
14 However, I stated earlier there are many
15 healthcare providers and consumers who know very
16 little about homeopathy. As it's our goal within
17 the HANP to be able to provide these people with
18 quality information, we have a suggestion in terms
19 of -- for the HANP suggestion -- is to maintain a
20 team within the FDA that consists of experts in
21 drug regulation, the representatives of the
22 American Association of Homeopathic Pharmacists,
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1 the American Pharmacopeia Convention of the United
2 States, as well as an expert clinical physician
3 who's on the front lines, who's practicing
4 homeopathy and fielding these questions daily to
5 help better this team.
6 A team comprised of such experts in the
7 field is vital and will be able to help clarify
8 any questions as to homeopathic labeling, and most
9 importantly, to ensure the safety of the
10 consumers.
11 In closing today, I want to end with a
12 story. One hundred and fifty years ago, on a
13 journey across the country -- the Oregon Trail --
14 a group of explorers got stuck in the Cascade
15 Mountains because of bad weather.
16 They had to abandon their wagons, and in
17 the process they chose to bury their most valuable
18 possessions. So when the weather -- when the
19 conditions were more favorable they could return
20 to get them. Amongst these things buried, there
21 was a small book written by homeopathic physician,
22 Constantine Hering, titled The Homeopathic
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1 Domestic Physician, and a small homeopathic
2 medicine kit.
3 For these people, and people since then,
4 homeopathic medicines have been effective and safe
5 to use at home if their condition was not intense
6 enough to need attention, but -- or was intense
7 enough to need attention at home, but not sever
8 enough to seek the care of a physician.
9 There are many books such as this book
10 that still guide the consumers and the lay public
11 about making informed decisions regarding drug
12 products labeled as homeopathic.
13 Because homeopathy is safe and it's
14 fairly easy for the consumer to understand what to
15 buy should they have minor health ailments, the
16 HANP highly encourages that these homeopathic
17 medicines continue to be available over the
18 counter because they are so effective in helping
19 improve the health of the population.
20 Thank you so much for your time and
21 consideration.
22 DR. WHYTE: Thank you, Lisa. And we'll
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1 have five minutes of questions. The timer is
2 already set, and we'll start with Dr. Nelson.
3 DR. NELSON: Two quick questions. I'm
4 curious if this Materia Medica Pura will be a
5 collation of the data or is there an intent to
6 provide a critical evaluation of the data that
7 exists?
8 And the second question is -- I was
9 struck by your final comment about self limited
10 illness and noticed the previous speaker had
11 rheumatoid arthritis, for example, on his list,
12 and it seemed that you were giving a much more
13 narrow focus of where homeopathy may have a place.
14 I wondered if you could comment.
15 MS. AMERINE: Sure. So, the first
16 question in regards to the Materia Medica Pura is
17 it's really just a collective data, so we collect
18 all of the data that we can find in any literature
19 that would be in existence for homeopathic
20 medicine, and we compile it into one location, so
21 then we can go back and look and see, you know,
22 what was this case? Or what were the toxicology
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1 reports or the provings? Or the way that in
2 homeopathy we find the indications of a homeopathy
3 medicine. So it's all collected in one source.
4 The second question, if I understand the
5 question correctly, is in regards to -- like the
6 previous person was mentioning, rheumatoid
7 arthritis versus the common cold. This is where
8 the difference comes in between a specialty in --
9 a specialist in homeopathy who is practicing
10 homeopathy as a physician, who understands the
11 disease, versus something that's over the counter.
12 I think if -- a simple condition like an
13 acute cold, if there's something that's -- that is
14 like an acute cold or some acute condition -- an
15 injury that doesn't need some care -- a sting of
16 an animal or a bruise -- you fell -- or something
17 of that sort. I think it's great, at home, over
18 the counter.
19 When we cross the line into some of
20 these more diagnostic or more severe illnesses -
21 rheumatoid arthritis, other autoimmune diseases --
22 I really think that it's important to have
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1 somebody who really understands medicine,
2 understands the prognosis of disease, so then you
3 can understand, is what we're treating what we
4 would expect, or is the disease pathology going on
5 as if nothing is being treated? Because if that's
6 the case, we need to address that and do what's
7 appropriate for the patient.
8 MS. LIPPMANN: Do you think your
9 patients understand what homeopathy is, the
10 mechanism by which it purports to work? For
11 example, the dilutions, the concept of like treats
12 like, the provings?
13 Do your patients understand that? And I
14 would ask the same about over the counter. Do you
15 think that the general public, who might go into a
16 CVS and purchase an over the counter homeopathic
17 product, do you have a sense that they have that
18 understanding?
19 DR. AMERINE: Sure. A lot of times when
20 they come into my practice they don't know. They
21 know that I do natural medicine. They want
22 something else. They know that I -- they have
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1 these questions, and they don't know, so I have to
2 give a lot of time on education for them, and
3 explain to them what homeopathy is, and explain
4 the dilution series. I always explain that to all
5 of my patients.
6 The question about the consumer --
7 there's a lot of confusion in the general
8 practitioner, or in the general consumer world,
9 and you get all kinds of questions, all kinds of
10 different pronunciations, you name it, and it
11 comes in.
12 So they don't really have a good idea.
13 They see something labeled as homeopathic, and
14 they have no idea if they can -- to distinguish
15 something like Arnica Montana for bruising, versus
16 some combination piece that actually has some
17 inactive ingredients that are actually serving as
18 the active ingredient to make it.
19 They don't know the difference of that,
20 and so I work really hard to educate people in my
21 direct practice, but that's a small amount
22 compared to the vast consumers.
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1 And so, I think that clarifying that
2 out, or having some boundaries around that better
3 would be a good idea.
4 DR. BENT: I'm interested in some of the
5 data sources that you have that would allow us to
6 understand purity and the effect of safety that
7 would feed into your compendium of information.
8 Do you have a surveillance protocol or how are you
9 coming up with information about the ingredients,
10 about the supply, about the purity?
11 DR. AMERINE: In terms of the over the
12 counter combination? Like what remedies are in
13 there?
14 DR. BENT: No, for any of them. It's
15 actually -- the actual supply chain for the
16 medicines that you're making.
17 DR. AMERINE: Sure. Well, if I
18 understand the question correctly, the way that we
19 know originally is we gather proving symptoms --
20 so we know the effects of the medicine in a
21 healthy person.
22 All of that data is collected, and we
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1 collect all of that, but that's not enough by
2 itself. So then we need to see what happens when
3 somebody who is ill takes something of this?
4 So, we have the collection of all of the
5 data together in our proving, or we get them in
6 toxicology reports. We know that if somebody
7 overdoses on something -- what happens if a
8 healthy person takes too much -- this information.
9 So, when we then are applying it -- so
10 that's what a foundation is, and then we have to
11 rely on the principle of homeopathy, that we're
12 prescribing a medicine that would cause symptoms
13 if the person didn't already have those symptoms.
14 DR. BENT: I actually want to clarify.
15 I'm not -- I was thinking more about the specific
16 ingredients used in the manufacturing of the
17 product.
18 So you have the toxicology reports, but
19 do you have other data that talks about the purity
20 and the safety of the product?
21 DR. AMERINE: Really, other than that,
22 that's kind of our foundation, where we go for --
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1 as far as I understand the question. Yeah.
2 DR. LOSTRITTO: Briefly. I see we're
3 close to out of time. I want to follow-up on that
4 question.
5 For the Materia Medica Pura project, I'd
6 like to ask you if you are also collecting data,
7 not only on the purity of the ingredients, the
8 excipients (ph) as well as the actives that are
9 diluted, but also on the manufacturing process,
10 which we know varies by dilution approach, by
11 succession methodology, and so forth.
12 Is this important information being
13 gathered? If yes, great. If no, why not?
14 DR. AMERINE: It is important
15 information being gathered because different
16 amounts of any product will cause different
17 varying of kind of symptoms, so that is included
18 into all of that.
19 So we'll collect information. If
20 somebody has taken something that's been diluted,
21 you know, one to 30 dilution, or 30c, or if
22 somebody took it in a crude dose, or if someone
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1 took it further down diluted.
2 We collect all of that because we want
3 to see what happens when something is taken --
4 when medicine is taken by a healthy person, what
5 symptoms occur at different stages.
6 DR. WHYTE: Brad, did you have a
7 question?
8 MR. PACE: Yeah. Generally speaking,
9 how does a homeopathic practitioner decide on what
10 route of administration to use when they're
11 treating patients, and are there, you know, any
12 concerning routes of administration that you see
13 either on the OTC or prescription homeopathic drug
14 market?
15 DR. AMERINE: Sure. Generally the
16 homeopathic physician is going to prescribe
17 orally, either with little pellets that are
18 dissolved under the tongue, or with a medicine
19 that's been diluted into water a little bit and
20 they take it into water.
21 There's all kinds of routes of
22 administrations that I have seen, and to be
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1 honest, there's not necessarily one way or another
2 that has laid out -- something I've thought about
3 a lot, is different administration routes -- is
4 something sprayed nasally? You know, is something
5 oral? Is it topical?
6 For the most part, I'm not -- depending
7 on the ingredient and the amount of the
8 ingredient, I'm not super concerned. Some of
9 these homeopathic products that are on the market
10 that are at a 1x or 2x dilution that are being
11 sprayed in the nasal cavity, for example, that has
12 potential to create some problems, so there's not
13 -- it's a tough question to answer because there's
14 a lot of "if this, then that."
15 Thank you.
16 DR. WHYTE: Well, thank you. So at this
17 point in time we're going to take a 15 minute
18 break. It is, according to my clock, 10:42, so we
19 will try to arrive back at around five of 11:00.
20 So, again, we'll take 15 minutes and we'll resume
21 at five of 11:00. Thank you.
22 (Off the record at approximately 10:42
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1 a.m.)
2 (Recess.)
3 (Back on the record.)
4 DR. WHYTE: We'll get started at another
5 minute or two.
6 (Pause.)
7 DR. WHYTE: What we're talking about
8 here is, it turns out when the panelists -- more
9 than one of them -- put their mic on, it actually
10 cancels out the mic, so the people in the overflow
11 room as well as online, can't hear.
12 So what we're suggesting is maybe people
13 will put their tents sideways and that way
14 people's mics won't cancel out. And, you know,
15 it's actually hard for me to see down there when
16 people's lights are tents, so I'll allow all of
17 you to self police. You are all very cordial so
18 I'll do that.
19 So we're going to go ahead and get
20 started. We have a couple of speakers before our
21 lunch break, and I see Amy Rothenberg's notes
22 here, so in case -- okay, well good, you're here.
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1 So if you weren't here I was going to present your
2 notes.
3 So we'll start off with Amy Rothenberg
4 from the American Association of Naturopathic
5 Physicians.
6 MS. ROTHENBERG: Thank you very much.
7 You probably would have done a really good job.
8 The writing was very big and clear, and hopefully
9 would be understandable by anybody.
10 Thank you for the opportunity to
11 present. My name is Amy Rothenberg. I represent
12 the American Association of Naturopathic
13 Physicians. I am also the President of the
14 Massachusetts Society of Naturopathic Doctors in
15 Massachusetts. I have no conflict of interest
16 whatsoever.
17 I am certified by the HANP that Dr.
18 Amerine spoke about just before the break. I also
19 sat on the Board of Health in Amherst,
20 Massachusetts for six years, bringing a natural
21 medicine perspective to the public health arena.
22 I recently stepped down as Vice
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1 President of the Amherst Survival Center that
2 offers free medical care, food, and clothing to
3 people in need -- another public health interest
4 of mine.
5 The AANP is a national professional
6 organization representing 4,500 licensed
7 naturopathic doctors in this country. Our members
8 are physicians trained as experts in natural
9 medicine.
10 In the clinic we take comprehensive
11 patient histories from our patients. We do
12 appropriate physical exams as indicated. We -- in
13 the states where we're licensed. There are 20
14 states and municipalities that license
15 naturopathic physicians at this time.
16 We order laboratory tests and diagnostic
17 imaging, and other diagnostic tests, and like
18 medical colleagues, we diagnose and treat disease.
19 Naturopathic doctors work
20 collaboratively across all forms of medicine. I
21 often send out, both for support diagnostically
22 and treatment wise for my patients, when I need
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1 help, and I also accept referrals from all
2 different kinds of doctors in my community and
3 even around the country.
4 We attend four years in residence, full-
5 time naturopathic medical school, post graduate,
6 and there are currently seven such schools in the
7 United States. Each are recognized by the
8 regional accrediting bodies and those
9 organizations are recognized by the Federal
10 Department of Education.
11 Our foundational work is equivalent to
12 that done by ND's and DO's in terms of the basic
13 sciences -- anatomy, physiology, biochemistry,
14 histology, etcetera -- and our systems review
15 classes as well. Things like radiology,
16 neurology, gynecology, immunology, dermatology,
17 pediatrics, etcetera.
18 In addition, naturopathic doctors study
19 - - the naturopathic approach is emphasizing both
20 disease prevention and lifestyle modification and
21 whole person wellness through therapeutic,
22 nutrition, botanical medicine, and homeopathy.
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1 Degrees are awarded after extensive
2 classroom study and clinical training. In order
3 to be licensed to practice, the MD must also pass
4 extensive post-doctoral exams and fulfill annual
5 continuing education requirements.
6 We provide treatments that are safe and
7 effective, and we are extensively trained in
8 pharmacology so that we are kept abreast about
9 drug and nutrient interactions, drug herb
10 interactions, and the like, to try to keep our
11 patients as safe as possible. We work with
12 compounding pharmacists as well to ensure safe and
13 comprehensive care.
14 We have practiced and taught homeopathy
15 since naturopathic medicine was defined as a
16 profession. We have primary care providers fully
17 trained in homeopathic prescribing and integrating
18 homeopathy into our naturopathic school education,
19 out board examinations, and into our clinical
20 practices.
21 Aside from my current positions that I
22 mentioned, I also cofounded the New England School
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1 of Homeopathy with my husband, Paul Herscue (ph)
2 who is another naturopathic doctor in Mass's
3 public health, one of the largest and oldest
4 continuous post graduate study program in
5 homeopathy in the United States, training
6 providers and physicians in the art and science of
7 homeopathy.
8 I've lectured extensively at places like
9 -- in homeopathy -- at the American Medical
10 Student Association, the American Holistic Nurses
11 Association, the Retail Clinicians Education
12 Congress, which has nurse practitioners and
13 pharmacists on board, at the University of
14 Massachusetts Medical School where they like to
15 trot me out periodically to talk about homeopathy
16 and natural medicine.
17 This is a fairly representative example
18 of naturopathic doctors and homeopathy in and
19 around this country at this point in time.
20 I would like to respond to two
21 particular questions posed by the FDA. The
22 question number one, what are consumer and
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1 healthcare providers attitudes toward human drug
2 biological products labeled as homeopathics? And
3 again, I don't know if I said, but I have been in
4 private practice for 30 years just about -- coming
5 on 30 years.
6 Homeopathy is perceived favorably by
7 both naturopathic doctors and patients, both for
8 its efficacy, but particularly because of its
9 safety profile and its inexpensive cost, as well
10 as the quality of the product.
11 The consistency and quality are
12 preserved by the American Association of
13 Homeopathic Pharmacists, and the Homeopathic
14 Pharmacopeia of the United States, using the CGMP
15 (ph) -- and taught to physicians -- and over
16 decades of use, I have not personally found
17 problems with variability or the quality of
18 homeopathic products, or toxicity.
19 The experience of naturopathic
20 physicians who use homeopathic products is
21 consistent with other licensed physicians reports
22 of homeopathic use, specifically positive,
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1 reliable results, with low toxicity, an affordable
2 and easy to administer, well tolerated product.
3 I'd like to address question number
4 four. Are there areas of the current CPG that
5 could benefit from additional clarity? If so,
6 please explain.
7 We believe -- the AANP believes that the
8 CPG Section 400.00, conditions under which
9 homeopathic drugs may be marketed -- is sufficient
10 as written. That said, we believe that
11 enforcement of those guidelines could be clarified
12 in collaboration with the American Association of
13 Homeopathic Pharmacists, the Homeopathic
14 Pharmacopeia, and the AANBP.
15 We've identified two particular areas
16 that reflect a need for further clarification or
17 compliance. The first one is CPG Section 400.00.
18 The definition states, "Drugs and products
19 containing ingredients in combination with non
20 homeopathic active ingredients are not homeopathic
21 drug products."
22 While the definition is clear and
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1 appropriate and accurate, and I don't think it
2 needs to change, I think there could be more
3 robust enforcement here. We have found a number
4 of products that use several ingredients where the
5 homeopathic drug is only one part and the rest of
6 the active ingredients are not homeopathic.
7 The AANP agrees with the FDA that these
8 should not be marketed as homeopathic products,
9 and again, this comes back to labeling and care
10 and accuracy that needs to go into any labeling
11 that's done.
12 And the second point that I wanted to
13 make is that the CPG Section 400.00 background
14 states that those products that are offered for
15 treatment of serious conditions must be dispensed
16 under the care of a licensed practitioner.
17 People who suffer from potentially life
18 threatening illnesses or more chronic ailments
19 should be treated by healthcare providers, by
20 licensed healthcare providers.
21 Having over the counter drugs,
22 homeopathic or otherwise, labeled in a confusing
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1 manner for consumers, should be avoided at all
2 cost. We urge that no homeopathic product be
3 labeled with any potentially life threatening
4 diseases, such as asthma, as a prominent feature.
5 While this is already in the guidelines
6 and need not change, it would be wise to build in
7 more interactions, just like this one, between the
8 FDA, the AAHP, the HPCUS, and the AANP, to clarify
9 best practices with regard to accurate labeling
10 guidelines.
11 That said, this potential is only --
12 this is only a hazard -- a potential hazard -- and
13 for me personally, in decades of teaching and
14 practicing and prescribing, caring for many
15 thousands of patients in my practice over the
16 years, I have not seen adverse effects. So we are
17 not seeking change in the current policy, only
18 further clarification and enforcement.
19 Of particular import is having properly
20 labeled homeopathic products stay over the counter
21 so they remain a choice for the public for self
22 care of self limiting problems, as talked about by
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1 Dr. Amering.
2 The change that we are recommending is
3 more interaction between the FDA and these
4 organizations and to have better compliance.
5 I wanted to take a minute to share -- to
6 dovetail off of something that Dr. Jonas spoke
7 about earlier related to laboratory research on
8 mechanism and action with homeopathy. I had the
9 great and distinct pleasure of meeting Dr. Edward
10 Calabrese, who is a PhD researcher at UMASS in
11 Amherst, after he had published an article in
12 Toxicology in 2013 called Hometic Mechanisms From
13 Critical Reviews. I'm sorry, Hometic Mechanism --
14 the journal was Critical Reviews in Toxicology.
15 And he lays out his understanding of the
16 mechanisms that play in hormesis, which is defined
17 as a dose response phenomenon characterized by low
18 dose stimulation and high dose inhibition.
19 Historically, dose responses have been thought to
20 occur in a limited fashion from low to high dose.
21 A non-linear response, such as the
22 hermetic response, has potential application in
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1 most every field in science. I think we could all
2 agree. His paper, and many, many others that he
3 has written, offer the first wide reaching
4 documentation of mechanisms -- of hermetic dose
5 concentration responses.
6 In his paper he wrote, and this is a
7 quote -- I don't write this eloquently -- so,
8 "Regardless of the model, in vitro or in vivo,
9 inducing agent input, or receptor cell similarly
10 pathway mediated mechanism, the quantitative
11 features of the hermetic dose concentration
12 responses are similar, suggesting that the
13 magnitude of the response is a measure of biologic
14 plasticity within a broad range of biological
15 context. These findings represent an important
16 advance in the understanding of the hermetic dose
17 concentration response, its generalizability, and
18 potential biomedical applications, including drug
19 discovery, efficacy assessment, and the risk
20 assessment process."
21 As a Professor of Toxicology at UMASS --
22 I live in Amherst, Massachusetts -- I decided I've
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1 got to meet this guy. I've got to take him out
2 for lunch and just talk to him a little bit
3 because I feel like what he's proposing -- and his
4 studies are quite well done. He was awarded the
5 Mari Puri
6 (ph) prize in 2009 for his work on
7 homesis (ph.)
8 In any case, over the last 20 years he's conceived
9 and carried out hundreds of experiments to test
10 and reconfirm his findings. He continues his work
11 with both chemical toxins, radiation, drugs,
12 hormones, and other categories of molecules, on
13 cells, on plants, and on animals. Regardless of
14 the agents used, the organism exposed, the hometic
15 dose response was observed.
16 He shared with me his interest in dose
17 related response was first peaked in a biology
18 undergraduate class studying plant physiology.
19 While conducting an experiment using synthetic
20 growth inhibitor on peppermint plants, it was
21 observed that some plant growth was instead
22 stimulated, the opposite of what was expected.
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1 His professor asked, "Anybody interested in
2 further study?" He was the only guy to raise his
3 hand.
4 As it turned out, the group had made a
5 dilutional error by a factor of ten. With very
6 low dose of growth inhibitor, plants grew more
7 than expected. At the higher doses of the growth
8 inhibitor, indeed the plant growth was stunted, as
9 predicted.
10 His advisor urged Calabrese to do many
11 more experiments to see if his observation was
12 real and reproducible. In experiment after
13 experiment after experiment over his long career,
14 the hometic results was observed.
15 So I only bring this up so that perhaps
16 if those of you on the panel are interested in
17 further study related to mechanism of action, this
18 might be a place to start. I would be happy to
19 put you in touch with Calabrese.
20 I did also want to share a personal
21 story. I'm going to switch hats here and share a
22 personal story about myself. You know, sometimes
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1 the doctor is the doctor sitting in the doctor
2 seat, and sometimes the doctor has to move over --
3 bump over a couple of seats -- and sit in the
4 patient's seat.
5 Last year I was treated for breast and
6 ovarian cancer. Thank you for your prayers and
7 good wishes. I have an excellent prognosis and
8 I'm going to do very well.
9 I did every single thing that
10 conventional medical care could have offered, from
11 surgery to lots of chemotherapy, to radiation
12 treatments, and a few other things. I'm on
13 Tamoxifen. I probably will be for life.
14 That said, at every step of the way I
15 also used homeopathy, and sometimes that was over
16 the counter, sometimes that was by visiting with a
17 homeopathic physician, and all I can tell you is
18 that my providers -- and I was being treated at
19 Mass General with -- the head of every department
20 at Mass General -- I have a very interesting case,
21 apparently.
22 Every step of the way, what I was told
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1 was, "Whatever you're doing, keep doing it." Some
2 people asked me what I was doing and I of course
3 was happy to share it, and I did write extensively
4 on the Huffington Post about my experience using
5 natural medicines, including homeopathy, alongside
6 conventional cancer care.
7 So, I just -- I'm bringing that up
8 because for me to be able to do my cancer care in
9 a way that was in harmony and in sync with my very
10 pristine lifestyle, my excellent diet, my use of
11 natural medicines, including homeopathy, was one
12 of the greatest gifts, both because I feel that I
13 was able to enhance the efficacy of conventional
14 care, I was able to reduce the side effects that I
15 might have experienced.
16 If I did have any side effects, I was
17 able to treat them early, quickly, and
18 effectively, and I was also able to really
19 maintain an excellent quality of life.
20 I mean, I had my -- my breast chemo was
21 in January and I feel like I look good, I sound
22 good, my brain is good, and I just feel like to
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1 have access to natural medicines at times of need,
2 even when the disease is quite serious and life
3 threatening, is a right that we have in this
4 country, and I would really like to see that right
5 protected.
6 So, I think in conclusion I would just
7 like to circle back around. We feel the AANP
8 believes that the FDA's current regulatory
9 approach to homeopathic products is working well.
10 The low cost of the medicines as well as the
11 consistent quality of product make them appealing
12 to both physician and patient.
13 Over decades of use we have not found
14 problems or variability with the quality of
15 homeopathic products, and not much toxicity has
16 ever been reported.
17 They should remain available to the
18 public OTC. We do recommend certain
19 clarifications and closer working relationships
20 between the FDA, the AANP, AAHP, the HPCUS -- the
21 whole alphabet soup there.
22 Thank you very much for allowing us to
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1 present these ideas.
2 DR. WHYTE: See, you didn't even need
3 your notes. You did well without them. And I'll
4 use the presiding officer's indulgence and thank
5 you for sharing your personal story. I know that
6 can be very hard to do in a professional and
7 public setting, so thank you for sharing your
8 story.
9 And my one question -=- we start the
10 time yet -- is did you get to go to the lunch?
11 Did he agree to lunch?
12 MS. ROTHENBERG: He did. He did. Thank
13 you.
14 DR. WHYTE: Okay. Good. All right.
15 We'll have five minutes on our clock and we'll
16 start our questions.
17 DR. LOSTRITTO: Yes. Thank you. I
18 wanted to ask you a clarifying question based on
19 your academic experience with the New England
20 School of Homeopathy, and also based on your
21 longstanding clinical practice.
22 In terms of prescription homeopathic
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1 products, in your estimation what percentages of
2 them are commercially -- just transferred and
3 given to the patient from a commercial source that
4 somebody else makes them, versus a percentage that
5 is prescribed and compounded by a pharmacist?
6 And if you could clarify, because it's a
7 little -- it's a little unclear -- by compounding
8 pharmacist, do you mean any pharmacist or a
9 specifically trained homeopathic pharmacist?
10 MS. ROTHENBERG: When I made that
11 comment in my talk there I was talking about
12 compounding pharmacists outside of the realm of
13 homeopathy. There are a lot of naturopathic
14 physicians who work with compounding pharmacists,
15 perhaps on biodentical (ph) hormones.
16 My experience is I only use homeopathic
17 remedies that have been purchased or have my
18 patients purchase from recognized homeopathic
19 pharmacies, and I do believe that there are some
20 practitioners who might ask a homeopathic pharmacy
21 to create a homeopathic remedy for them from this
22 particular product.
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1 I personally have never done that so I'm
2 not a good person to ask about that, but I -- that
3 is a great question and really, I was referring
4 more toward botanicals as opposed to -- and
5 hormone replacement -- as opposed to homeopathy.
6 MR. PACE: Um, this is kind of a general
7 question, but how would you define a homeopathic
8 product, and how can you ensure that the products
9 that you're using in your practice are prepared
10 according to the tenants of homeopathy?
11 MS. ROTHENBERG: I love that question.
12 Thank you very much. Our homeopathic pharmacies
13 are awesome and I have perfect faith in them. I
14 have to just say it like that.
15 I am not -- I cannot be -- I'm an expert
16 in a number of things. I cannot be an expert in
17 everything. I have left that job to the
18 homeopathic pharmacies, and I trust them and I
19 have faith in them, and I have just built my
20 career around that, and I don't waiver there.
21 I'm not interested in somebody in the
22 back room somewhere mixing up something and then
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1 diluting it and shaking it. I'm not interested in
2 that. I want it coming from a reputable,
3 licensed, homeopathic pharmacy, and those are the
4 -- that's where we put all our faith, you know?
5 We really do.
6 I hope that doesn't sound, you know,
7 hokie, but that's -- I think there are a lot of
8 practitioners that, you know, they're not the
9 pharmacist and they're not the person making the
10 medicine, they're the person who is taking the
11 time to understand their patients in great detail
12 and prescribe for them an appropriate remedy for
13 them at that point in time. So -- yeah.
14 MR. PACE: How does that compare to what
15 is on the OTC drug market that are labeled as
16 homeopathic now?
17 MS. ROTHENBERG: Yes. I think that the
18 whole area of labeling is really at the heart of
19 this hearing, and I think that the things that are
20 labeled homeopathic that are just a single dose of
21 one remedy, that's what it would consider
22 homeopathic.
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1 And so the things that are mixed up
2 together with other things, supplements, herbs,
3 that's not homeopathic. That's something else.
4 For something to be homeopathic, it has
5 to have been proven on healthy people. Healthy
6 people had to take it over and over and over
7 again, and then we -- they were watched to see
8 what kind of symptoms, if any -- if they were
9 sensitive to that product that they would be
10 reactive to and develop symptoms from, and then
11 those symptoms are collated and that is what we
12 use to prescribe upon.
13 So, if something has lots of different
14 things in it, it's kind of like poly pharmacy,
15 it's not homeopathy. It's something, it's not
16 homeopathy.
17 So, for me -- for it to be homeopathic
18 it has to just be the homeopathic remedy, and I
19 think labeling an accurate -- really being
20 sticklers around accurate labeling is central.
21 DR. NELSON: Thank you. If I could
22 follow up. You mentioned in your talk the
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1 confidence you have in positive, reliable,
2 results, and I guess I'm curious -- separating out
3 the sort of proving -- and the single ingredient,
4 single dosage, just espoused -- how do you as a
5 practitioner then assess whether you've had
6 reliable, positive results when you've prescribed
7 one of these products?
8 MS. ROTHENBERG: That's a terrific
9 question. I personally really like outside,
10 objective, evidence. So if I can ever do anything
11 that's related to lab work, or related to the
12 assessments of other people with different
13 expertise than my own -- on a patient.
14 I'll give you an example. If I have a
15 child that I'm treating on the autistic spectrum,
16 and I'm using homeopathy with that family or that
17 child, I am not so much interested in the mom's
18 perception of how the child's doing, in terms of
19 you know, getting better at communicating, maybe
20 toileting, maybe learning the "ABC's," I'm
21 interested in their teacher's and their
22 therapist's reports because I fell like using
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1 other people's assessment tools are very
2 important.
3 And as a physician, I think any
4 physician has ways of telling if their patient is
5 better. It hurts less, it bothers them less, it
6 itches them less, it's less annoying, their mind
7 is clearer, their sleep is better, their energy is
8 better.
9 I mean, these are all guideposts that
10 all doctors use, naturopathic doctors, medical
11 doctors, homeopathy, pharmaceuticals, it doesn't
12 matter. We want to see that our patients are
13 improving, and so we try to do that by asking good
14 questions, taking a very good, detailed history
15 initially, so that we can back and we can refer to
16 that. What were we trying to hit here?
17 And then, also, really being sure
18 whenever possible to use more objective ways of
19 figuring out if what we're doing if effective.
20 DR. WHYTE: Dr. Nelson says he has just
21 a little bitty follow-up.
22 DR. NELSON: A little follow-up. You
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1 strike me as someone who uses a lot of tools in
2 giving your description.
3 So I'm curious, are you showing --
4 seeing these results as a result of only
5 prescribing homeopathic, or are you using all the
6 various tools that you have and then you see a
7 result? So can you actually attribute it to the
8 homeopathic product, or is it everything you do?
9 MS. ROTHENBERG: Thank you for that
10 question. I think that like a lot of
11 practitioners, we do what we need to do.
12 I have many patients for whom I only use
13 homeopathy because they have another naturopathic
14 doctor that they go to for everything else, and
15 they're just coming to me for homeopathy. I have
16 some patients who come to me who have no idea what
17 homeopathy is, and they really just want me to do
18 whatever I do.
19 And so the answer is, for some of the
20 patients, it's only homeopathy. In may practice
21 that's probably half of my patients, and for the
22 other half of my patients, it's things related to
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1 therapy, nutrition, botanical medicine.
2 I do work with lifestyle modification
3 with all of my patients, and I think most
4 practitioners worth their weight in anything are
5 going to try to get people to, you know, eat
6 better, move more, do relaxation kind of
7 techniques, have good relationships. I mean,
8 these seem like the bread and butter of a good
9 practitioner.
10 But in terms of, who do I see that's
11 just homeopathy, and I think that their
12 improvement or their progress, or maybe their lack
13 of that, is due to just homeopathy, it's probably
14 about half of my practice.
15 Does that answer your question?
16 DR. NELSON: Yes.
17 MS. ROTHENBERG: Thank you very much.
18 DR. WHYTE: Thank you. And now we will
19 turn to Mr. Bruce Shelton -- Dr. Bruce Shelton,
20 excuse me -- from the Arizona Homeopathic and
21 Integrative Medical Association.
22 DR. SHELTON: Good morning, everyone.
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1 My name is Dr. Bruce Shelton, MD, MDH. The MDH
2 means that I am licensed by the State of Arizona
3 to be a medical doctor, homeopath. Our state is
4 one of the three in the country that have such a
5 licensing board. The other two are Nevada and
6 Connecticut.
7 As such, our physicians in Arizona are
8 all graduates of MD and DO medical schools in the
9 United States. Oh, and I forgot to mention, I
10 earn the majority of my income from my private
11 practice in Phoenix and I'm a torturer of myself
12 for moonlighting. I work for homeopathic
13 manufacturers to teach other doctors how to use
14 products. I even helped develop some of them.
15 Okay?
16 We chose to answer this survey by
17 answering the questions that were posed by the
18 FDA, which we totally appreciate. Personally,
19 I've overseen 20,000 patient visits in practice
20 over the last 25 years since I became a
21 homeopathic, who have benefited from homeopathy.
22 It's critical to my personal success in helping
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1 patients, particularly those who haven't been
2 helped elsewhere.
3 I have a truly complimentary practice.
4 There are definitely times where you need to use
5 regular drugs and there are times when
6 homeopathics are more appropriate, and our
7 profession allows the use of both, and my training
8 allows me to chose in between them. Okay.
9 I've never experienced in my practice
10 any safety or quality issues that warrant major
11 trouble. In my 25 years of practice with these
12 20,000 patient visits, I've had very few, if any,
13 material adverse events reported by my patients,
14 and have helped many recover from symptoms that
15 didn't respond to other types of medical care. I
16 see a lot of people that have been to other
17 doctors who couldn't help them.
18 There are almost 100 AHIMA, the Arizona
19 Homeopathic Integrated Medical Association,
20 practitioners who we estimate over the last 15
21 years have each seen 1,500 to 2,000 patient
22 visits, leading to a conservative estimate of
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1 2,000,000 patient visits over this time period.
2 Now, I told you -- or I didn't tell you
3 - - I am the President of our licensing board.
4 I've served on it for about half of this time. We
5 only see three to six complaints a year on the
6 average from the public for adverse complaints,
7 none of which are ever related to the use of the
8 wrong homeopathic remedy.
9 We've seen complaints from doctors who
10 didn't pay their taxes and have gone to jail and
11 have been in danger of losing their licenses.
12 We've seen people allowing non-licensed
13 practitioners come in their offices, but the
14 majority of what we see at our board, where -- I'm
15 a regulator like all these nice people are, and we
16 help protect the public based upon the law that we
17 have in Arizona.
18 I understand it's a difficult job. I
19 don't envy you. I kind of, sort of, do the same
20 thing, and it's not easy sometimes. Okay.
21 The federal regulations are clear that
22 homeopathy should be available for use and
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1 regulated under the HPUS guidelines. It's
2 important for practitioners to be able to choose
3 the appropriate medical path for their patients,
4 especially in non life threatening situations, and
5 in areas where other medical options have failed
6 their patients.
7 The next question -- of the other
8 countries, what do they do there regarding
9 homeopathy and what should we say about the FDA's
10 thinking in this area?
11 We found in our research that no major
12 organization, country, or government in the world
13 has determined that homeopathy isn't safe. All
14 major countries allow homeopathics to be used as
15 one of the many available medical therapies.
16 According to the World Health
17 Organization in a report they had entitled, Legal
18 Status of Traditional Medicine and Complimentary
19 Alternative Medicine, a World War Review, only the
20 country of Honduras does not allow the practice of
21 homeopathy along with all the other kinds of
22 complementary medicine. One country in the whole
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1 word. Honduras. Don't go there -- go on vacation
2 and get sick. Sorry, Honduras. Never been there.
3 A homeopathy is recognized and utilized
4 as a system of medicine by most of the major
5 countries. The World Health Organization
6 published the 20 Top Ranked Healthcare Systems by
7 Country in the Year 2000, the latest year of a
8 report.
9 Of the top 20 countries worldwide, with
10 populations greater than 5,000,000, all 12 of the
11 top 20 countries on the list with populations
12 greater than 5,000,000 allow homeopathy to be
13 utilized. Nine of the 12 have officially
14 recognized homeopathy as a medical therapy.
15 Homeopathy is a material portion of the
16 medical systems in the countries throughout the
17 world that are considered first rate, such as
18 France, Germany, and Great Britain. Many doctors
19 in those countries use homeopathic therapies along
20 with non homeopathic drugs to a great effect.
21 France was rated the number one by the World
22 Health Organization.
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1 In 1997 it recognized homeopathy as a
2 medical therapeutic method. Thirty nine percent
3 of French physicians have prescribed homeopathics.
4 Multiple French medical schools offer a degree in
5 homeopathy and all pharmacy schools in France
6 teach homeopathic courses.
7 According to the British Medical Journal
8 in the Netherlands, 40% of the general
9 practitioners use homeopathy.
10 A five year comprehensive review
11 completed by the Swiss government examined
12 efficacy, real world effectiveness,
13 appropriateness, safety, and economy of medical
14 therapies. The review found that the individual
15 CAM interventions, especially homeopathy, were
16 effective -- under Swiss conditions -- safe, and
17 far as could be judged from the trial situation --
18 also cost efficient.
19 Homeopathy is a major source of
20 healthcare in India. A recent Lancet paper says
21 that 100 million Indians use it as their sole
22 source of healthcare, and according to the Journal
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1 Med India, there are 185 homeopathic colleges, and
2 11,000 homeopathic hospital beds.
3 Next question; are the policies of
4 enforcement under CPG appropriate to protect and
5 promote public health in light of the tremendous
6 growth in the homeopathic drug market?
7 In our opinion, there's no need to
8 change the guidelines. The public is currently
9 adequately protected by FDA regulatory authority.
10 The 400.400 CPG monograph totally outlines it and
11 the good companies that follow GMP practices do it
12 appropriately.
13 The Federal Trade Commission is there to
14 protect the public, and of course the legal
15 system, if there's ever a question. The FDA has
16 substantial regulatory authority right now to
17 ensure public safety. Homeopathics are
18 manufactured under strict GMP guidelines with the
19 homeopathic process as defined in the HBUS.
20 The current 400.400 provides substantial
21 guidance for the marketing of homeopathic
22 products. It effectively regulates all uses to
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1 ensure safety, product quality, labeling
2 guidelines, and the OTC indications for the
3 majority of these products. It ensures
4 homepathics are not used for non OTC indications.
5 The FTC monitors the healthcare industry
6 regularly, including homeopathics, focusing on
7 issues such as false advertising and unreasonable
8 claims.
9 The FDA and the FTC regularly work
10 together, jointly when they have to, using the
11 regulatory power that they currently have to
12 educate consumers, ensure proper messaging and
13 marketing to provide public safety and awareness.
14 The next question, the OTC question --
15 the products available have a wide variety of
16 indications and many of these have never been
17 considered for OTC use under the formal process.
18 Okay. Homeopathic indications have
19 always been regulated through the HPUS, and other
20 accepted monographs and scientific data. Don't
21 forget, science in the homeopathic world is the
22 proving, which is really a study, and the Materia
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1 Medica and the reparatory are the bibles that we
2 use in the homeopathic world to see if things are
3 fitting properly.
4 Any other regulation of indications
5 would mean that these substances would no longer
6 fall under the definition of a homeopathic.
7 Homeopathic principles, as directed by the HBUS,
8 dictate a specific method of determining correct
9 indications.
10 The current system of determining the
11 appropriate indications is fundamental and is a
12 core premise of homeopathy that has been safely
13 and effectively used since its inception.
14 The FDA has provided clear guidance that
15 OTC can only apply for conditions that a consumer
16 can self diagnose, self treat, and self manage.
17 Therefore, homeopathics are safe and appropriately
18 regulated for OTC conditions.
19 The FDA currently has ample regulatory
20 power to ensure that indications are appropriate
21 for OTC use. There's a clear standard for the FDA
22 to regulate current indications that fall outside
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1 these guidelines for non prescription products.
2 The FDA already provides appropriate
3 guidance and enforcement. The FDA regularly
4 issues warning letters. Talk to anyone who's ever
5 received one -- what -- the fear it strikes in
6 their hearts -- has -- regularly issues warning
7 letters to manufacturers or sellers of
8 homeopathics that are promulgated indications that
9 are outside the realm. You either change or you
10 close your business. A lot of businesses have.
11 Do consumers and healthcare providers
12 have adequate information to make informed
13 decisions about drug products labeled as
14 homeopathic? If not, what information, including,
15 for example, information on labeling?
16 The current labeling and available
17 resources provide substantial information to
18 support use of homeopathic products when consumers
19 -- with consumers -- and inform them about use of
20 the products.
21 There are detailed labeling guidelines
22 that must be followed that are robust and
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1 adequate. The indications provided are simple and
2 straightforward. The individual ingredient
3 information is readily available to the public
4 through multiple sources.
5 Healthcare providers have even greater
6 access to help them make informed patient
7 decisions. Doctors have access to textbooks,
8 educational courses, software programs, internet
9 compendiums, to provide further understanding of
10 homeopathics might best be used with an individual
11 patient.
12 In conclusion, therefore, homeopathics
13 are safe, effective, and crucial to our ability to
14 treat patients. The current regulatory structure
15 meets the needs of consumers and healthcare
16 providers, and ensures standards of quality by
17 homeopathic drug manufacturers. There are no need
18 for changes to the current regulations.
19 Thank you very much for letting me be
20 here.
21 DR. WHYTE: All right. Thank you, Dr.
22 Shelton. We now have five minutes of questions.
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1 Let's start at the front, closest to me, and we'll
2 just run down the list. Now Kate threw it in at
3 the end, but let's start with Kate and then we'll
4 just go down the row.
5 MR. WU: Dr. Shelton, you mentioned that
6 interestingly there's only one nation in the
7 world, Honduras -- they don't allow the
8 homeotherapy. Could you elaborate a little bit for
9 the why this nation, they are not allowed to --
10 DR. SHELTON: To be honest with you, I
11 don't know why Honduras feels the way it does. We
12 gave the reference in the little handout that goes
13 with my notes and we can ask the World Health
14 Organization. I don't know.
15 MR. WU: And also related to that -- so
16 you also mentioned other examples of countries
17 like France and Swiss. So how these countries
18 evaluate -- I'll say the effectiveness of the home
19 therapy?
20 DR. SHELTON: Listen, it's my
21 understanding that the United States of America
22 went through a period known as the Flexner Report,
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1 where homeopathy was thrown under the bus for
2 about 50 years, and the other countries never got
3 thrown under the bus, so they're ahead of us.
4 These countries are the home of where
5 Dr. Hahnemann lived. Dr. Hahnemann came from
6 Germany. He got remarried at the age of 80 to a 29
7 year old woman and moved to Paris where he
8 finished his life's work. He is buried in Paris.
9 I actually visited his monument here in
10 Washington yesterday. He's the only medical
11 doctor in the history of the United States that's
12 ever had a statue in Washington, and he never came
13 to this country.
14 The form of medicine in this country for
15 many years was homeopathy only, and the scientific
16 world of the drug companies helped stop the use of
17 it. We've woken up. We agree with it. We have
18 lived with it. But the people that use homeopathy
19 believe in it and it's coming back. The public
20 wants to have it.
21 I have a book with me right now. You
22 have no idea how many internet letters have come
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1 with these hearings of people and patients who
2 don't want anything done to take their
3 homeopathics away from them. They actually fear
4 that this hearing itself is going to do something
5 bad, and we've tried to explain to them, "They're
6 just reviewing the regulations. They are supposed
7 to. They need to, and we agree with the proper
8 safety of the public. Don't go off the wall yet."
9 I hope that answers your question.
10 MR. PACE: You indicated that consumers
11 make informed decision about homeopathic drug
12 products. How do you define an informed choice
13 for a person walking down an OTC pharmacy drug
14 aisle?
15 DR. SHELTON: Well, there's a lot of
16 people that are very frustrated with the regular
17 system. I mean, that's -- the majority of the
18 people that I see in my office -- and I have a
19 medical office that still does all the charting
20 the way the government wants us to do it right
21 now.
22 I'm outside of the insurance industry,
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1 which doesn't cover homeopathy. People are
2 willing to pay for it, they're so frustrated.
3 They walk down the aisle in the stores and they
4 see something labeled as homeopathic. They've
5 heard that it works. Maybe that might be the one
6 thing that you ought to be discussing, is how to
7 better clarify that.
8 But as far as I'm concerned, they're
9 looking for answers. This country is very
10 frustrated with the system as it currently exists,
11 and I'm sure you have to be aware of that, that
12 the change needs to be made in the education of
13 the public, that there are answers outside of the
14 current mainstream system.
15 DR. NELSON: So I'd like to just ask a
16 question of clarification of your argument. I
17 hope this is a simple answer, if I have it correct
18 or not. We'll see.
19 But I gather your argument about proving
20 and about the current regulatory process being
21 appropriate is that in fact once there is a
22 proving, that to require any other empirical
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1 evidence beyond a proving that that product works
2 in any way would be inconsistent with the
3 principles of homeopathy, and would violate
4 therefore the homeopathic pharmacopeia. Did I
5 hear that right?
6 DR. SHELTON: Well, listen, there's no
7 reason not add more information and knowledge to
8 anything that we do in the world, but we shouldn't
9 make it onerous to the point that it would put the
10 existing things out of business.
11 A homeopathic proving is a very exacting
12 method of knowing what's going on. It's not done
13 in a test tube, it's done between two individuals,
14 the patient and the doctor that's treating them,
15 and adequately writing down what their symptoms
16 are, and you assume that the supervisor of the
17 proving is an honest person that can properly
18 distill the information that they get.
19 I mean, those things are really double
20 blind to some degree. I mean, they're double
21 blind completely and they work. And that's what
22 makes up the HPUS.
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1 I mean, if you could -- if someone would
2 come along and win the Nobel Prize and tell us
3 what's actually happening in the energetic
4 solutions that we have, we're all in favor of
5 that. I'd like to volunteer to be part of writing
6 it up.
7 DR. WHYTE: Dr. Michele, do you have a
8 question?
9 DR. MICHELE: Yeah. So just to follow
10 up on that. Could you explain how the proving is
11 double blind in that you've got a practitioner and
12 you've got a patient, and they're writing it down?
13 So how is that double blind?
14 DR. SHELTON: There's three people
15 involved. There's a master supervisor that knows
16 what the proving is all about. The person who is
17 taking the symptoms from the patient is a
18 homeopath who doesn't know what the remedy was and
19 doesn't know what the outcome is supposed to be.
20 Of course, the patient doesn't know
21 anything until it's all over, until it's all
22 unsealed, and you have to trust the master
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1 supervisor that no one is going unnecessarily at
2 health risk.
3 I mean, the proving that I've watched
4 have been done in Phoenix at the American Medical
5 College of Homeopathy, under Dr. Todd Rowe, who I
6 consider one of the most ethical men I've ever
7 met, and nothing bad is allowed to go on, and
8 that's how it's double blind.
9 It would be triple blind if none of them
10 knew what was going on, but the master person
11 always knows what's going on.
12 DR. LOSTRITTO: I'll keep my -- I'll
13 bullet down my question to be more brief. In your
14 state, what is the relationship between the
15 practice of homeopathy and both homeopathic
16 pharmacies and so-called conventional pharmacies
17 that would do compounding of specific homeopathic
18 remedies for you?
19 DR. SHELTON: There aren't that many
20 compounding homeopathic pharmacies in our state.
21 I mean, we rely upon the manufacturers to sell
22 these products to the doctors and the patients,
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1 and it's my understanding that they're totally
2 looked over by the FDA in audits that could be
3 considered grueling to any business -- to have
4 someone come in and sit there and say, "What's
5 this? Why is that? Where is the data? Is it
6 clean? Is it not clean?"
7 The GMP standards that are followed by
8 these manufacturers are totally appropriate and
9 they're totally honest, and I would say further
10 about Arizona, Arizona has developed a unique
11 inter relationship between all the different
12 modalities.
13 I mean, we have a huge naturopathic
14 community that we work together -- you're going to
15 hear from the President of our homeopathic -- of
16 our naturopathic school. Even the AMA regularly
17 supports the things we do at the legislature.
18 I mean, even the AMA regularly supports
19 the things we do at the legislature. I mean, it's
20 surprising that once people start talking to each
21 other and understanding the other person's point
22 of view, what actually happens, and the prejudices
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1 seem to dissolve. It's my goal to help dissolve
2 those barriers, not increase them.
3 DR. WHYTE: We have time for one more
4 quick question.
5 MS. LIPPMANN: You said you are in favor
6 of there being as much information as possible,
7 but you don't want there to be so much need for it
8 that it's onerous on manufacturers. Can you
9 explain what specifically about FDA's scientific
10 process for establishing safety and efficacy is
11 inconsistent with homeopathy?
12 DR. SHELTON: Personally, I think the
13 FDA is doing is job properly to some degree. I
14 mean, you're overseeing the manufacturer, which is
15 really what you're supposed to do. You're
16 overseeing the labeling, and from what I
17 understand, you're doing a good job at that.
18 You're overseeing the enforcement, and I
19 know there are some businesses and customers that
20 are unhappy, but the net result is the community
21 always benefits.
22 I think you're doing fine right now.
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1 You don't need to do anymore. You've got enough
2 paper to deal with.
3 DR. WHYTE: Kate, did you have a quick
4 question you wanted to ask?
5 DR. BENT: You had observed that the
6 individual ingredient information is readily
7 available to the public and even more so to
8 providers, but many of the homeopathic products
9 actually have multiple ingredients.
10 So, is it sufficient that each
11 ingredient has a clinical trial, and if so, why?
12 DR. SHELTON: To be honest with you, it
13 needs to be tested as the group. I mean, I've
14 learned my homeopathy from Dr. Hans Heinrich
15 Reckeweg, who I never met, who is the father of
16 homotoxicology, which is the field where remedies
17 are mixed together to create newer remedies.
18 It's those mixtures that become a
19 different product, as opposed to the individual
20 ingredients, and taken as a single product,
21 studies on those would be great to have. I would
22 love to see someone spend the money to do that.
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1 DR. WHYTE: Thank you.
2 DR. SHELTON: Thank you. I appreciate
3 being here.
4 DR. WHYTE: Well, thank you, Dr.
5 Shelton. And that gives me an opportunity to
6 follow up on some Washington trivia, since he said
7 there was a statue of Samuel Hahnemann.
8 You won't have time at lunch to go see
9 it because it's at 18th and Massachusetts -- 16th
10 and Massachusetts -- in Washington, D.C., but
11 perhaps you can go this evening. And there's
12 actually a statue of Daniel Webster right next to
13 it, so a great American Revolutionist.
14 I don't know if Jeannine will know him
15 from Canada, but that is our next speaker. From
16 Ottawa, Canada, Jeannine Ritchot from Health
17 Canada.
18 MS. RITCHOT: Thank you very much for
19 having me. I am -- my name is Jeannine Ritchot,
20 and I'm the Acting Director General of the Natural
21 and Non-Prescription Health Products Director at
22 Health Canada.
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1 Full disclosure, I am about five and a
2 half weeks in to this new role, and so I do hope
3 that I will be able to answer any questions that
4 the panel has for me, and if not, I will endeavor
5 to bring back some answers for you.
6 I would like to take the opportunity --
7 oh, did I just hang up on somebody by any single
8 chance at all? I hope everybody on the webinar
9 can still hear me because I might have pressed a
10 button I shouldn't have pressed. My apologies.
11 I'm not technologically astute.
12 So, I would like to thank the FDA for
13 inviting me to come and provide an overview of how
14 homeopathic medicines are regulated in Canada.
15 Just, if you'll permit me, I think this is even
16 more important in this day and age that we work
17 together with our regulatory counterparts.
18 In an every evolving marketplace, when
19 products can cross borders much more easily than
20 they could have, I think these are important
21 conversations to have with one another and I'm
22 quite happy to be here. I'm also quite happy to
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1 have the opportunity, as I am so new, to meet so
2 many stakeholders aside from my FDA counterparts.
3 I am going to talk a little bit about
4 how we regulate in Canada. We do have a premarket
5 regulatory framework. And I'm also going to talk
6 just a little bit about some of our current
7 context, including some of our challenges as move
8 forward in this area.
9 So, let me begin by talking a little bit
10 about Health Canada's regulatory role. Our
11 mandate, of course, is to ensure that Canadians
12 stay safe and stay healthy, and we regulate a
13 variety of commodities, whether they be consumer
14 products, whether they be drugs, whether they be
15 food.
16 In my world, the Natural and Non
17 Prescription Health Products Directorate, we
18 regulate natural health products as well as non
19 prescription drugs, and we also regulate
20 disinfectants, which are considered -- in some
21 cases are considered drugs -- and some cosmetics,
22 as well, although that's not up on the slide.
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1 Our role is to ensure that Canadians
2 have access to these commodities -- in my world,
3 NHP's and non prescription and disinfectant drugs
4 -- that are safe, effective, and of high quality.
5 In the case of natural health products, in Canada
6 that does include homeopathic medicines.
7 So, what is a natural health product?
8 In Canada, a natural health product refers to a
9 range of products and you can see them up here on
10 the slide. Toothpaste, protein powder, minerals
11 and supplements, plant based remedies, and
12 homeopathic medicines. So the net is cast rather
13 wide with respect to natural health products.
14 In order to be authorized to see and
15 bring to market and manufacture a natural health
16 product in Canada, you do need to apply through
17 our framework, which we'll get into, and you know
18 -- consumers know that it has been authorized in
19 this premarket regulatory framework.
20 They know that it's been authorized
21 because a natural health product bears what we
22 call and NPN, or a natural product number, and a
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1 homeopathic medicine will bear a DINHM (ph,) or a
2 drug identification number homeopathic medicine,
3 on their label. These must be displayed
4 prominently so that Canadians have confidence that
5 these have indeed been approved by Health Canada.
6 There are currently over 80,000 NHP's
7 authorized for sale in Canada. I probably should
8 have asked somebody in my office what the number
9 of homeopathic medicines were, but I didn't think
10 to do that before coming here.
11 So, let's just talk a little bit about
12 how we regulate natural health products in Canada.
13 Natural health products do have their own set of
14 regulations underneath the Food and Drugs Act. In
15 this regulatory framework, the natural health
16 products regulation came in to being in 2004.
17 These cover -- as I said, there is a
18 premarket as well as a post market regime, so we
19 cover product licensing. In order to sell and
20 manufacture a product in Canada, you must have a
21 product license, so you must come to us for
22 approval.
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1 We also have a site licensing, so once
2 your product is approved, if you want to -- it's -
3 - for the manufacturing and the sale -- that's
4 where you also need to have your site where the
5 products are made -- licensed. And we also have
6 post market reporting requirements, as well as
7 compliance and enforcement.
8 Now, I should pause here and I should
9 just say that on the compliance and enforcement
10 side, our national compliance and enforcement
11 program is run by an organization within Health
12 Canada known as the Inspectorate, and it is
13 responsible for providing compliance and
14 enforcement, inspections, etcetera, across all
15 commodities.
16 As a result, we operate in a risk based
17 - - in a risk based way -- and it is fair to say
18 that natural health products as a category are not
19 what keeps our inspectorate the most busy, because
20 generally speaking, they are on the lower risk
21 side of all the commodities that we regulate under
22 the Food and Drugs Act.
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1 That's not to say that it's nonexistent.
2 In fact, last week, with my colleagues from the
3 Inspectorate, we issued a recall on a homeopathic
4 product containing male fern (ph,) which was found
5 to be in excess of -- which was found to be in
6 excess of the appropriate amounts for consumption
7 - - for safe consumption. So there is a
8 compliance and enforcement arm.
9 On the premarket side, in order to
10 become licensed we require companies to submit
11 information about the safety and efficacy of the
12 product, or to meet a monographed standard. And
13 I'm going to get into a bit more detail about the
14 evidentiary standards in a moment, but for now I
15 will just say that the regulations themselves are
16 not prescriptive as they pertain to the evidence,
17 the evidence is rather outlined in guidance
18 documents. So, the evidence is policy, not -- the
19 evidence requirements are policy and not
20 regulation.
21 Homeopathic medicines do have -- do fall
22 under the definition of a natural health product,
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1 and they are specifically referenced within the
2 regulations. They are in scope of this particular
3 regulation.
4 This was not always the case for
5 homeopathic medicines. Before the natural health
6 product regulations came into effect, homeopathic
7 medicines fell under the food and drug
8 regulations, so they were regulated as a non
9 prescription drug.
10 I should say that Health Canada -- while
11 Health Canada has always had a history of strong
12 relationships with its stakeholders -- and
13 throughout the 1990's there was a lot of
14 conversation with healthcare practitioners, with
15 industry associations, regarding whether or not
16 this regulation of homeopathic medicines as a non
17 prescription drug was appropriate, and we did hear
18 concerns from those sectors and we did work as a
19 Department with our stakeholders to try to address
20 some of those concerns.
21 One of the concerns that was raised in
22 the '90's, from particularly the homeopathic
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1 medicines industry, was that homeopathic medicines
2 should be allowed to use condition specific
3 product claims on their labels. So, "This is a
4 homeopathic remedy effective for the treatment of
5 symptom 'x" as opposed to just the general
6 homeopathic remedy that was on the label.
7 In 1997 we did update our policy to
8 allow specific health claims as we deemed them to
9 be appropriate in a self care setting. This is,
10 again, a policy decision. It's never been
11 enshrined in the regulation itself, but it does
12 remain in effect to this date.
13 So let's just talk briefly -- and I
14 believe this is my last slide. Let's talk briefly
15 about licensing and evidence requirements for
16 medicines in Canada.
17 So, as I said, there are two ways to
18 license homeopathic medicines. There's the non
19 specific claims route, which does remain open. So
20 a label would, in that case, simply bear words to
21 the effect of, "Homeopathic remedy," or "This is a
22 homeopathic medicine." And then we have a
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1 category for specific claims, so, "This is a
2 homeopathic remedy for the relief of 'xy'
3 symptom."
4 The licensing pathways for homeopathics,
5 there is one distinct licensing pathway for
6 homeopathics under our regulatory framework.
7 There are two others, which I'll just talk about
8 first maybe.
9 The first is the modern NHP licensing
10 pathway. So that is where evidence is stratified
11 based on the risk of that product that the
12 manufacturer wants to bring to market, and
13 depending on that risk, that will sort of lead you
14 to the type of evidence that we would require from
15 you.
16 So this can range from textbook
17 references to perhaps a positive decision from
18 another regulatory agency, or it can be clinical
19 trial data, so perhaps this is the more similar to
20 our OTC framework.
21 We also have a traditional NHP evidence
22 pathway or licensing pathway. So this is for the
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1 use of traditional Chinese medicine, Aurvedic (ph)
2 medicine, and the evidence must point to an
3 extended history of use, and it must come from an
4 appropriate reference text.
5 With homeopathic medicines -- and this
6 is the third pathway, so again, it is a distinct
7 licensing pathway under our framework -- evidence
8 must come from an accepted homeopathic reference.
9 So we've talked a lot about them today.
10 I won't spend too much time -- I won't spend too
11 much time talking about it now. I will just say
12 that there are some products where we might get
13 evidence from a clinical trial, and that's, of
14 course, very welcome.
15 The evidence that we ask -- particularly
16 when you want to make a specific claim, we ask
17 that you provide us with evidence that supports
18 the conditions of use, claims, dose, and route of
19 administration, and again, comes from proving or
20 from homeopathic pharmacopeia or Materia Medica,
21 which have been referenced today.
22 I would just like to end by maybe
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1 talking very briefly about the context in Canada
2 at this point today. First of all, I think it's
3 fair to acknowledge that Health Canada is a
4 science based organization, and there is a natural
5 tension that comes from a science based
6 organization working in this area.
7 That said, the Canadian government did
8 make a decision that it wanted to provide access
9 to these alternate sources of healthcare and the
10 treatments that come with them. It wanted to
11 provide access to those who have cultural or
12 philosophical, or whatever other reasons there may
13 be that they wish to have access to these as well
14 as the more traditionally pharmaceutical products.
15 So that means that we, in my role and my
16 team, are always striving to balance that natural
17 tension between the need for strong science as we
18 play our role regulators, and the need to allow
19 for access.
20 What that effectively means is that we
21 have to maintain really strong relationships with
22 our stakeholders, be they industry associations,
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1 be they practitioners. We have regular buy lots
2 with many of our stakeholders so that we can
3 understand the issues that they are seeing, so
4 that we can understand some of the challenges in
5 this area.
6 But also as a good regulator, we have an
7 obligation to review all of our regulatory
8 frameworks on a regular basis to make sure that we
9 have it right, so I'm particularly interested in
10 my new capacity in this role, in working with my
11 international counterparts, and continuing these
12 discussions with all of the relevant players,
13 because it would be -- it would be inappropriate
14 to say that we have everything right, that we have
15 struck the exact right balance in Canada -- and we
16 continue to work with our partners and our
17 counterparts to make sure that moving forward our
18 regulatory framework in this area remains strong.
19 So, I will leave it at that. Thank you
20 very much for your time.
21 DR. WHYTE: Thank you. So we will reset
22 the clock and we have minutes of questions, and
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1 we'll start with -- we'll start at the very -- you
2 know what? Last time we started at that end.
3 This time we'll start at this end.
4 DR. IZEM: Thank you for your
5 presentation. I have a few clarifying questions
6 for your last slide here. So the level of
7 evidence is the same for non specific claims or
8 for specific claims? And also -- yes, so that's--
9 MS. RITCHOT: In the review process, if
10 a company is making or a manufacturer is making a
11 non specific claim, then they would have to
12 provide us with evidence from -- with the specific
13 references, for example, to homeopathic
14 pharmacopeia, that state that yes, this has been
15 used to treat "xy or z" condition or symptom.
16 For specific -- for non specific claims,
17 they still have to -- they still have to point to
18 the same general references, the difference being
19 that they're not claiming that it's for something
20 specific. So the level of specificity of what
21 they point to is not quite the same.
22 DR. LOSTRITTO: Hi. Thank you. I have
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1 three questions, but two of them are very quick.
2 The licensing for homeopathic products, is it open
3 ended or what's the duration of it before
4 relicensing, if any has to occur?
5 Second, on this line right here, you
6 have listed three types of -- three pathways for
7 licensing homeopathic products. If you could
8 briefly describe how the consumer or the physician
9 knows about these pathways.
10 And thirdly, other than the inspectorate
11 situation, when you receive information for
12 licensing, do you require any CMC information,
13 such as the quality or purity of the ingredients,
14 stability, and so forth?
15 MS. RITCHOT: Yes, thank you. And I
16 hope I -- I didn't bring a pen, so I hope I
17 remember all three questions.
18 So, the second question is what I'm
19 going to start with because I'm looking at the
20 slide here. Thank you very much. To be clear,
21 those are three pathways for all natural health
22 products, not just for homeopathic medicines.
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1 So the first is the distinct pathway for
2 homeopathic medicines, and I should have made this
3 more clear on the slide. The second are not
4 pathways for homeopathic medicines, but for all
5 the other NHP's that come under the same
6 regulatory framework.
7 Your second question was CMC, which I
8 think might be the same as our good manufacturing
9 products. There is -- we call it GMP -- there is
10 an attestation process that is part of the
11 licensing, so manufacturers must attest to
12 upholding GMP standards.
13 On the compliance and enforcement side -
14 - in the world of mostly prescription drugs and
15 controlled substances -- for example, there's
16 mandatory inspections that doesn't exist here.
17 And I apologize because I didn't have
18 John's pen -- I do forget the first question.
19 DR. LOSTRITTO: Briefly, how long is the
20 licensing good for?
21 MS. RITCHOT: Thank you. It's open
22 ended.
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1 MS. MICHELE: So thank you for that
2 presentation. You noted that in -- prior to 2004,
3 these products in Canada were regulated as non
4 prescription drugs, and then it changed to natural
5 health products.
6 Could you comment on how the regulatory
7 requirements changed for these products at that
8 time?
9 MS. RITCHOT: Could I comment on that
10 five and a half weeks in? I'm not sure how useful
11 it will be, but I'd be happy to get back to you
12 afterward just as a general observation.
13 I'm also responsible for over the
14 counter -- for the regulation of over the counter
15 products now, and one of the reasons that it was
16 moved into the natural health product directorate
17 is because of the acknowledgement by Health Canada
18 that, generally speaking, the gamut of self care
19 products, by no means are they all low risk
20 products, but they are more alike in terms of
21 regulation than perhaps an over the counter and a
22 prescription drug.
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1 So they are still done rather
2 differently. There is a higher evidence standard,
3 for example, for over the counter products, but
4 they are being lumped together in one directorate
5 because of this general recognition that there's
6 more likeness between perhaps the natural health
7 product world and the over the counter, than there
8 is between prescription drug and over the counter.
9 But I would be happy to further that conversation
10 outside of this forum.
11 DR. NELSON: Thank you for your
12 presentation. I'm curious about the example you
13 gave of the enforcement action, and how that might
14 reveal thoughts about low concentration, which I
15 gather is high potency versus high concentration,
16 which is low potency, which to some might seem
17 counterintuitive, but I guess in homeopathy it's
18 not, and I appreciate that.
19 How one arrived at the potency or
20 concentration of which that product that you
21 decided was outside of the manufacturing limits
22 was in fact outside? In other words, are you
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1 trying to make judgments of the concentration and
2 perhaps getting towards where lower concentration
3 or higher potency products would be therefore of a
4 lower risk, and how did you find out about it?
5 How do you frame that?
6 MS. RITCHOT: Absolutely. It was not
7 outside of the manufacturing limits. It was
8 outside of what we understand, based on evidence
9 about this product in particular, to be the safe
10 level of consumption.
11 In this particular case we did receive -
12 - and this is an example of, if I may brag for a
13 moment, of what I think a good regulatory agency
14 should always be doing.
15 We received an application for a
16 product, not homeopathic, that contained this
17 ingredient, male fern, and in the process of
18 looking at this we had a few other products
19 containing this ingredient already on the market
20 and approved.
21 In the process of doing the review, new
22 evidence since the last time that we have
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1 regulated one of these products has come to light,
2 and our product application officer did what we
3 call a health risk assessment, and this caused
4 some concern with respect to levels that may be
5 existing in some of our other NHP's that we have
6 licensed.
7 So we took a look at the amounts that we
8 had previously licensed, and in this case we did
9 find in one homeopathic medicine that the dilution
10 factor was quite low. In this case I believe it
11 was possibly even the mother tincture, and as a
12 result, we removed it from the market.
13 So, it's in the process of reviewing
14 incoming product licenses, that we go back
15 sometimes and look at -- did we -- have we always
16 had it right? Or has there been new evidence that
17 comes up that makes us take a look at some of what
18 we may have already licensed?
19 MR. PACE: Are there distinctions
20 between prescription and OTC homeopathic products?
21 MS. RITCHOT: As far as I know, no,
22 there's no distinction. I'm not -- there's no
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1 distinct category of prescription homeopathic
2 products, if that's the question.
3 DR. WHYTE: Thank you. All right. And
4 our last speaker before lunch is Melanie Grimes.
5 Melanie has some concerns about the technical
6 issues, so we'll bear with her.
7 MS. GRIMES: Thank you so much. I've
8 edited homeopathic journals for the HANP and other
9 homeopathic organizations for over 30 years. I've
10 lectured internationally and been adjunct faculty
11 at Bastyr University, and currently receive a
12 million visits a year on my websites. I've also
13 conducted homeopathic provings.
14 My father was a Naval Officer in World
15 War II, who served as a cabinet member under two
16 Presidents, as Deputy Commissioner of Education,
17 so I have a great respect for the government and
18 the Administration, and I thank you all for your
19 efforts.
20 First, I'd like to address the FDA's
21 concerns about the safety of homeopathic remedies,
22 and I want to tell you about the homeopathic
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1 practice of Dr. Bastyr, the namesake of the
2 accredited medical university, Bastyr University.
3 Dr. Bastyr said, "I am a Homeopath," and
4 he treated 90% of his 70,000 -- 50,000 patients --
5 over five generations and seven decades with
6 homeopathy with no reported adverse events, and
7 Dr. Bastyr educated his patients in the proper use
8 of over the counter homeopathic remedies, as do
9 many of the students that he taught, and I know
10 this is something that is taught in the
11 naturopathic colleges as well.
12 Also, I want to -- secondly I want to
13 mention that I am a DES daughter. I was infertile
14 because of a damage to my uterus caused before I
15 was born by a pharmaceutical drug. I had a son
16 who died halfway through my pregnancy at 22 weeks
17 gestational age because of anatomical
18 abnormalities caused by diethylstilbestrol, an FDA
19 approved treatment against miscarriage that my
20 mother's OB prescribed, and she took dutifully
21 every day of her pregnancy. She was 24 years old
22 with no history of miscarriage.
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1 My son, Ivan, who would be 36 years old
2 this week, weighed less than one pound at his
3 birth. He has fused fingers and eyelids, and
4 suffocated being born, and to this day no preemies
5 born at 22 gestational weeks survive.
6 After my son died, my OB told me that
7 there was a 75% chance that every pregnancy I had
8 would terminate at 22 weeks because of the DES. I
9 consulted with Dr. Bastyr, who treated me with a
10 low potency homeopathic remedy, and enabled me to
11 carry two lovely sons to term births, and I am now
12 the proud mother and grandmother, and I have Dr.
13 Bastyr and homeopathy to thank.
14 I am one of the women about whom Dr.
15 Bastyr used to boast, "I got a lot of women
16 pregnant." That's -- my father and the family
17 that we have because of homeopathy. So, this is
18 the legacy of homeopathy.
19 And I want to tell you also about Marion
20 Belle Rood. Dr. Rood was a homeopathic practice
21 at the end of a dirt road for 50 years, from noon
22 until 1:00 o'clock in the morning, until she died
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1 at the age of 96 in 1995.
2 She testified when The Pharmacopeia was
3 reviewed in the 1980's, and she raised and
4 contributed $50,000.00 to fund the updating of the
5 U.S. Homeopathic Pharmacopeia. She charged $10.00
6 of her patients, and she raised it to $20.00, and
7 that's how she managed to do that.
8 So, over the next two days you'll hear
9 testimony from a dedicated group of homeopaths.
10 There are many more lucrative career choices than
11 homeopathy, in spite of its recent growth.
12 In my 40 years, I know of no one has
13 chosen this career for its financial gain. I know
14 of no one who has dedicated their lives to
15 dispensing placebo or sugar pills, right? I know
16 - - and I can tell you the American homeopathic
17 community is compassionate, hard working,
18 dedicated, as were their mentors like Dr. Bastyr
19 and Dr. Rood, and I know that if the FDA wants to
20 collaborate, that there are no better partners
21 than the manufacturers of the homeopathic remedies
22 and the homeopathic practitioners.
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1 Hahnemann's motto and his credo was odes
2 operas (ph) and it means in Latin, "to dare to
3 know," and to investigate the truth it takes great
4 bravery. So I thank you all for your time.
5 DR. WHYTE: Thank you. Now we'll have
6 five minutes of questions from the panel.
7 (No audible response.)
8 DR. WHYTE: All right.
9 MS. GRIMES: Well, then can I answer
10 some of the questions that were answered before?
11 DR. WHYTE: On -- we probably have about
12 40 seconds left, so if you want use 40 seconds.
13 MS. GRIMES: Okay. First of all, I
14 would like to say that when you talk about
15 proving, also in the Materia Medica, we also use
16 clinical data. It's important to understand that.
17 Hahnemann was the inventor of the
18 sterile field. He was a scientist quite revered
19 in his day and age. President McKinley was
20 attended by a homeopathic physician, and I believe
21 if you're trying to look for the cause -- the
22 method of action of homeopathy, that the field of
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1 epigenetics is going to start to show how
2 homeopathy works, and once we start to look at the
3 affect of these remedies on the genes, I think
4 we'll start to understand some of the ways that
5 homeopathy works.
6 DR. WHYTE: Great. Thank you. So now
7 we will break for lunch. We're running only about
8 five minutes behind schedule. If we can
9 synchronize our watches, it's 12:10, because it
10 doesn't seem like there's a clock in here. I
11 don't know. We will resume promptly at 1:10.
12 If you did not preorder your lunch, I'm
13 told you can still buy your lunch out there. So
14 see you all in one hour at 1:10.
15 (Off the record at approximately 12:10
16 p.m.)
17 (Recess.)
18 (Back on the record.)
19 DR. WHYTE: Well, good afternoon, again.
20 For those that were not here this morning, I am
21 Dr. John Whyte, the Director of the Professional
22 Affairs and Stakeholder Engagement Group here in
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1 the Food and Drug Administration.
2 I want to thank everyone for being so
3 prompt in sticking to your time. It helps all of
4 us have an opportunity to hear from each other, as
5 well as to leave before traffic gets way too busy
6 for all of you.
7 Just a housekeeping note, there are some
8 members of the press who are here. I do want to
9 remind them that panelists should not be
10 approached directly, but instead we have our press
11 officer here, Chris Kelly, and Chris is standing.
12 So any members of the media, feel free to direct
13 your questions or inquiries to Mr. Kelly and he
14 will refer you to the right person. So that's our
15 policy here at the FDA. That's the policy that we
16 adhere to for every type of meeting.
17 So we're now going to start our
18 afternoon session and we are going to start with
19 Marcel Fraix from the Western University of Health
20 Sciences and the College of Osteopathic Medicine
21 of the Pacific.
22 DR. FRAIX: Good afternoon, everyone.
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1 I'd like to just say thank you for being invited,
2 first of all, by the FDA, to speak on this
3 important matter. I know it's a challenge to
4 strike that balance between taking care of the
5 safety of our patients and the consumers, as well
6 as maintaining access to the things that can
7 potentially be of benefit to them.
8 So, my name is Marcel Fraix. I'm an
9 Osteopathic Physician. I actually came out here
10 from California. I am board certified in physical
11 medicine, rehabilitation, by the American Board of
12 Physical Medicine and Rehabilitation, as well as
13 the American Osteopathic Board of Physical
14 Medicine and Rehabilitation.
15 I am an Associate Professor at Western
16 University of Health Sciences, as well as the
17 Chair of that department, and I am clinically
18 active as well as -- performed research activity
19 at the University. About half of my time is spent
20 seeing patients.
21 In that regard, the patients that I
22 primarily see are in the context of pain
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1 management, and I will be speaking a little about
2 how I integrate clinical homeopathy in the
3 practice of pain management.
4 The other part of my activities at the
5 University involve, specifically, research
6 activity, and I want to be clear on that. I am
7 not researching homeopathy, and I will not be
8 specifically focusing on the research during my
9 presentation here.
10 My focus is really to give a clinical
11 perspective as a physician, in terms of how I've
12 seen homeopathy being integrated as well as
13 address some key questions by the FDA panel.
14 Lastly, I am a teacher for the Center
15 for Education Development of Homeopathy, which
16 I've been doing for approximately a decade.
17 So, I'd like to keep this presentation
18 to the point and be fairly succinct. I will
19 definitely answer any questions that come up
20 though.
21 The first question, what are consumer
22 and healthcare provider attitudes toward human
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1 drug and biological products labeled as
2 homeopathic? Now, again, as my perspective as a
3 clinician that integrates homeopathy into his
4 practice, I would say that amongst the patients
5 that come and see me, the vast majority are fairly
6 aware of what homeopathic medicines are. They're
7 aware of the limitations as well as the potential
8 benefits.
9 So, why is that important? Well, it's
10 important because in my clinical practice most
11 people seek me out because they know I integrate
12 this. Oftentimes they come to me because they are
13 receiving standard of care but they want more, or
14 they want an integration of standard of care and
15 using homeopathic medicines.
16 And it's important, and I really stress
17 this point, that I only treat patients with
18 clinical homeopathy when they are being provided
19 with management that is a standard of care in
20 terms of clinical practice.
21 That's a very important point, and often
22 times I see in the medical community that things
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1 become quite polarized, that it has to be either
2 or, and that is definitely not the case.
3 You can provide symptomatic relief with
4 homeopathic medicines while at the same time
5 provide standard of care that is generally
6 accepted by the medical community.
7 So, what is a practical example and what
8 would that look like in my practice? I see a fair
9 number of patients with, for example, back pain.
10 Now, oftentimes I am having not only to diagnose
11 and treat that -- that could involve
12 interventional procedures, it can involve
13 medicines, it can be referral to one of my
14 surgical colleagues, but they also may be --
15 patients may be also interested in saying, "Well,
16 how can I potentially reduce my pain with
17 homeopathic medicines and integrate that into the
18 context of other medicines that are being used?"
19 And that's a very useful tool to me as a
20 clinician, because as -- those of us who practice
21 clinically, we know that every medicine
22 potentially has risks and it has benefits, and I
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1 have to weigh those in the context of a specific
2 patient, and also see how the integration of
3 homeopathic medicine may avoid -- may help me
4 avoid some of the risks that I may face with more
5 conventional medicines. So, it's an integrated
6 process.
7 With regards to my colleagues and their
8 familiarity with clinical homeopathy, oftentimes I
9 find that once they are familiar with what I do
10 and we've had a conversation, especially in terms
11 of what evidence exists, the limitations and
12 benefits of homeopathic medicines, that they're
13 fairly receptive and comfortable with me since I
14 provide an integrative approach to the patients
15 that they are referring to me.
16 The second question, do consumers and
17 healthcare providers have adequate information to
18 make informed decisions about drug products
19 labeled as homeopathic?
20 Again, in the context of my clinical
21 practice, I would say that most of my patients are
22 fairly well informed of what that entails, and I
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1 think with the advent of the internet and the wide
2 array of information that is out there, oftentimes
3 they have a lot of information that we have to
4 sift through together and to say what is useful
5 and what's not.
6 But in general, they come very well
7 prepared, and I would dare say, most of the time
8 they are more informed about homeopathic medicines
9 than they are about the conventional medicines
10 that oftentimes they are prescribed. And I think
11 that's an important point to take into
12 consideration.
13 Now, with regards to healthcare
14 providers, I'd say amongst the clinicians that I
15 help teach in the Center for Education and
16 Development of Homeopathy, they are also fairly
17 well represented in terms of understanding the
18 limitations, benefits, of homeopathic medicines,
19 and the clinical indications.
20 Now, that's, again, a bit biased because
21 I am showing -- you know, talking about a specific
22 group of individuals, but amongst those people who
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1 make the effort and -- to understand what's going
2 on, they are fairly well versed in terms of what
3 clinical homeopathy entails.
4 So that concludes my discussion. I
5 tried to be distinct and brief and to the point,
6 but please ask me any questions.
7 DR. WHYTE: Okay. With that we'll start
8 with five minutes of questions and we'll start
9 with Kate and then we'll go from there.
10 DR. BENT: Thank you. You described to
11 us that your patients arrive well informed and
12 well prepared, and you also noted that every
13 medicine has both benefits and risks.
14 Can you tell us a little bit more about
15 what your patients understand about the risks of
16 their homeopathic treatments?
17 DR. FRAIX: I think the -- in terms of
18 risks of homeopathic medicines, I think the
19 biggest risk that they understand is that it
20 potentially may do nothing at all. That would be
21 if you want to define it as a risk. In terms of
22 there being adverse outcomes, usually they do not
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1 have any issues regarding that.
2 DR. LOSTRITTO: Hi. What role do you
3 think labeling plays in either the problem of
4 incomplete information transfer or what role do
5 you see it playing to mitigate that?
6 DR. FRAIX: You know, I think it's hard
7 to distill a large amount of information in a
8 small label. I guess a reality that we're all
9 faced with. And I think that goes for whether
10 we're talking about a conventional medicine or a
11 homeopathic medicine.
12 I think that having some type of
13 labeling system that potentially would refer
14 patients to a more comprehensive compendium of
15 information that would allow them to educate
16 themselves more and have a discussion with their
17 healthcare provider would be helpful.
18 But I scratch my head sometimes to think
19 that -- what could we potentially do better than
20 we're doing right now?
21 DR. LOSTRITTO: Quick follow. Do you
22 see a role for med guides?
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1 DR. FRAIX: Oh, what's that?
2 DR. LOSTRITTO: I'm sorry. Do you see a
3 role for medication guides?
4 DR. FRAIX: I'm sorry, I --
5 DR. LOSTRITTO: A role for medication
6 guides.
7 DR. FRAIX: Oh, do I see -- yes. I
8 think anything that helps the consumer or the
9 patient be more informed is an important -- would
10 be something that would be helpful.
11 DR. NELSON: I was struck by your
12 comments about patient motivation. I'm just
13 curious if you could tease that apart,
14 particularly for the new patient that arrives
15 perhaps dissatisfied, as you would say, or seeking
16 something else, and teasing apart whether they're
17 there because they just know your sort of a
18 holistic approach, or whether you're a natural --
19 you know, you do natural products of homeopathic.
20 I mean, how much do they really have an
21 understanding of each or those different
22 components, and how much of that actually emerges
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1 after your interaction with them over time?
2 DR. FRAIX: That's a good question. I'd
3 say, by and large, most of the time we find an
4 integrated approach, which means that I will
5 provide treatment that's generally accepted by the
6 medical community and used all of the time, and
7 I'll integrate that with homeopathic medicine.
8 Having said that, there are rare
9 circumstances where I do have patients that come
10 to me and for whatever reason -- maybe they had an
11 experience in the medical community that was
12 suboptimal and they're afraid of using standard
13 care, and I have to have an extensive discussion
14 with them to understand why that arose in the
15 first place.
16 And if they're not willing to, you know,
17 provide standard of care in a circumstance that is
18 truly indicated, I inform them that I can't be
19 treating them with only homeopathic medicines.
20 Does that help? Or please clarify
21 further if you'd like more.
22 DR. NELSON: Well, it helps. I guess I
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1 was interested in just unpacking the extent to
2 which they come into your setting with sort of
3 prior knowledge of these, at times, subtle
4 distinctions between homeopathic, naturopathic,
5 holistic, and so on and so forth, and all of the
6 various alternative complementary approaches,
7 whether that, in their mind, is clear, or is it
8 really only clear after you've had an opportunity
9 to go through it with them?
10 DR. FRAIX: Good question. Yeah. I
11 think there can be confusion that people may lump
12 homeopathic medicines into different categories,
13 let's say, like naturopathic medicine, or they may
14 have a confusion that maybe different
15 practitioners use homeopathic medicines, or who's
16 specific domain do they belong to?
17 I think at the end of the day, however,
18 we always end up -- they have a clear
19 understanding of how it potentially can be
20 integrated.
21 DR. WHYTE: Well, thank you. Our next
22 speaker is M'Lou Arnett. Hopefully I pronounced
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1 your name correctly, from Matrixx Initiatives,
2 Incorporated.
3 MS. ARNETT: Thank you, John. Nicely
4 done on the name. It's not an easy one.
5 (Inaudible.) Is this the button?
6 DR. WHYTE: Yes.
7 MS. ARNETT: Okay. Good afternoon. My
8 name is M'Lou Arnett, and I'm the CEO of Matrixx
9 Initiatives. Thank you for the opportunity to
10 speak this afternoon. This is an important public
11 hearing regarding homeopathic product regulation.
12 By way of background, Matrixx is a
13 consumer healthcare company engaged in the
14 development and marketing of over the counter
15 homeopathic and non homeopathic products to meet
16 the healthcare needs of busy consumers suffering
17 from common, self treatable, conditions.
18 It's best products, Zicam cold remedies,
19 have been established as safe and effective in
20 reducing the duration of the common cold.
21 Customer surveys repeated over many years report
22 an extremely high degree of satisfaction with
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1 Matrixx products, thereby confirming the public
2 interest in assuring continued ease of access to
3 these and other safe, effective, and affordable
4 homeopathic pharmaceutical products.
5 The FDA's current GPG is an appropriate
6 framework which enables companies to bring to
7 market homeopathic OTC products which are safe and
8 effective when treating minor medical conditions.
9 The CPG has served FDA and consumers well.
10 To that end, Matrixx is pleased to
11 provide its input as it concerns FDA's inquiry
12 regarding the appropriateness of the current
13 enforcement policies under the CPG, and to shed
14 light on what processes our company employs when
15 evaluating whether a drug is appropriate for
16 distribution as an OTC drug.
17 So, what makes a homeopathic product
18 appropriate for OTC use? Our company employs a
19 two-step process for establishing that a
20 homeopathic product is a appropriate for OTC use.
21 Our process is consistent with FDA's
22 compliance policy guide, 400.400, and these steps
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1 are: One, review of the proposed formulation to
2 confirm its safety for OTC use. And, two, review
3 of proposed uses or indications.
4 First we review the proposed product
5 uses and indications. We confirm that the product
6 indications are supportive in the homeopathic
7 literature, which includes Materia Medica as well
8 as other clinical literature involving homeopathic
9 drugs.
10 We then assess whether the indications
11 for use meet the FDA/CPG requirement, which
12 stipulates that an OTC homeopathic product must be
13 intended solely for self limiting disease, a
14 condition amenable to self-diagnosis and self-
15 treatment.
16 To that end, it is Matrixx's policy to
17 require that the medical condition be one that has
18 been deemed acceptable for self-treatment under
19 FDA's OTC monograph process. As FDA knows, under
20 the OTC monograph process, FDA establishes drug
21 ingredients as generally recognized as safe and
22 effective for OTC use to treat certain medical
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1 conditions.
2 The OTC monograph process reflects FDA's
3 determination that these medical conditions are
4 self-diagnosable, self-limiting, and self-
5 treatable, and thus appropriate for the OTC space.
6 For example, FDA has OTC drug monographs
7 for drug ingredients that can treat colds,
8 allergies, headaches, minor cuts, and indigestion.
9 Zicam Cold Remedy has indications for the common
10 cold and Zicam allergy relief has indications for
11 the relief of allergy symptoms. Both address
12 conditions acknowledged by FDA as appropriate for
13 treatment with an OTC product.
14 Second, with regard to ingredient
15 strength, the Homeophathic Pharmacopeia of the
16 United States includes a guideline that describes
17 potencies at or above which each homeopathic drug
18 ingredient may be offered for sale without a
19 prescription. That's the key step to confirm that
20 all active drug ingredients are at potencies
21 consistent with the HPUS OTC guideline for such
22 ingredients.
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1 By following these guidelines, we ensure
2 that our homeopathic products only address
3 conditions that have been determined by FDA to be
4 self-diagnosable, self-limiting, and self-
5 treatable, and therefore appropriate for OTC use.
6 Safety remains primary. Along with
7 aligning with the HPUS, OTC guideline for potency,
8 and its review of toxicological data prior to
9 marketing homeopathic products, Matrixx post-
10 marketing, third party (inaudible) efforts
11 regularly reaffirm the safety of its products.
12 The FDA's current CPG sets forth a
13 framework that allows consumers to have safe -- to
14 have access to safe homeopathic OTC products to
15 treat minor medical conditions.
16 While Matrixx has focused its comments
17 today on its policies for determining the
18 appropriate OTC indication for use, the company's
19 commitment to safety of its products remains first
20 and foremost. The CPG has served FDA consumers
21 in the homeopathic community well. Matrixx
22 believes the current CPG is adequate to advise the
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1 homeopathic industry on how to appropriately
2 identify products that can be marketed as OTC, and
3 that it provides FDA with an excellent guide to
4 take action where products do not comply.
5 Once again, thank you for the
6 opportunity to speak at this important meeting.
7 DR. WHYTE: And we'll start with
8 questions with -- from this side first, and we'll
9 start with -- Kate, do you have -- with Rima.
10 DR. IZEM: Thank you for the
11 presentation. You said in one of your earlier
12 slides that your products have been established as
13 safe and effective. Could you give us a little
14 bit more detail on what data was used to establish
15 the efficacy and the safety?
16 MS. ARNETT: Well, as homeopathic
17 products, we look to the HBUS for ingredients that
18 are available to us for use for the conditions we
19 intend to treat, and to the Materia Medica and
20 third party literature for information on safety
21 and efficacy. Also with certain of our products
22 we have independent clinical trials.
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1 MS. LIPPMANN: Hi. Good afternoon. I'm
2 interested in your thoughts about the placement of
3 homeopathic products on pharmacy shelves in close
4 proximity with allopathic counterparts.
5 I'm interested to know if you think that
6 there is an implication of equivalency in that
7 placement, and I'm wondering if you or others in
8 your position make any effort to clarify or make
9 clear the distinction between homeopathic products
10 and allopathic?
11 MS. ARNETT: That's an excellent
12 question. In my experience -- most of my career
13 has been spent in OTC pharmaceuticals and personal
14 care products, and in my experience, consumers
15 really want the product that works for the
16 condition they need to treat, regardless -- you
17 know, if they're somewhat agnostic as to exactly -
18 - some of the specificity in terms of regulatory
19 framework.
20 We label all of our homeopathic products
21 on many labels of the carton, including
22 prominently on the front principle display panel,
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1 "Homeopathic." So if a consumer is either seeking
2 a homeopathic product or seeking not to use a
3 homeopathic product, that's clear.
4 In the case of Zicam Cold Remedy, as an
5 example, it's a product that treats the common
6 cold, shortens the duration of a cold and treats
7 the symptoms.
8 A consumer coming into the store looking
9 for something because here she is suffering from a
10 cold will go to the cough/cold aisle and look at
11 the vast array of choices there, and choose from
12 among those based on what symptoms they -- you
13 know, what exactly they're suffering.
14 And so, it's completely appropriate to
15 have that along with allopathic medicines at the
16 same time because it gives the range of choices
17 and we label in order to give him or her the
18 information needed.
19 MS. LIPPMANN: And just to clarify. Do
20 you think then that there is currently sufficient
21 information in the label? You said that it's
22 marked as "homeopathic." Do you feel like that is
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1 sufficient information for the average consumer to
2 understand what a homeopathic product is, how it
3 purports to work, and what the difference is
4 between that and a regular product?
5 MS. ARNETT: Well, what I'd like to say
6 is that I don't know that the consumer is really
7 that focused on how it purports to work or not.
8 So, I'll take the example -- what I
9 consider to be a parallel example. We go to the
10 gastrointestinal category where we have antacids,
11 H2 antagonists, and proton pump inhibitors, and
12 consumers have indigestion, and so they would go
13 and see what's available to them for OTC use and
14 make a choice based on what the label says in
15 terms of treating, and what exactly their symptoms
16 are and what their experience is, and if it works
17 for them they'll go back again.
18 I'm pretty sure most consumers, unless
19 they've had an in depth conversation with their
20 doctor, would not be able to tell us the
21 difference between an H2 antagonists and a proton
22 pump inhibitor, and what a (inaudible) cell is.
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1 So, the -- we are very diligent about
2 making sure that if homeopathic status is
3 important, it's there. The labeling says it's a
4 self -- you know, how to use it, how long to use
5 it, how frequently to use it, active and inactive
6 are listed.
7 So, I think -- I really believe that all
8 of the information needed for a consumer with a
9 self-limiting, self-diagnosable, and self-
10 treatable condition, can pick up our product and
11 feel confident.
12 DR. LOSTRITTO: Hi. Thank you. In one
13 of your slides just a couple ago, you listed a two
14 step process and step two was, "review proposed
15 formulation to confirm safety for OTC use, and
16 that potencies meet the Homeopathic Pharmacopeia
17 of the United States.
18 Could you describe to the extent you
19 can, without disclosing proprietary information
20 perhaps, what exactly does Matrixx do to confirm
21 the quality of incoming ingredients, and to what
22 extent do you validate your processes?
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1 I understand that you're not going to
2 take a 30c product and be able to assay that, but
3 as a check on your sicussion (ph) and dilution
4 process, do you take intermediate steps and assay
5 for content where that is analytically feasible
6 perhaps?
7 I'm just -- in general, can you comment
8 on the quality stream you have and the quality
9 controls you have for incoming ingredients to
10 final product?
11 MS. ARNETT: Sure. I'm happy to do
12 that. So all of our manufactured -- all of our
13 products are manufactured under CGNP standards and
14 compliance, and in CGNP facilities. With the
15 diluted tinctures we -- so we have a certificate
16 of analysis from our source that documents each
17 and every step of the dilution.
18 At this level, this much was found, and
19 then diluted one more, and then this -- and so on
20 and so forth, and I can't speak quite as
21 eloquently as some of our scientific colleagues
22 could on exactly what the -- but we have the C of
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1 A (ph) for the incoming material.
2 We also have release testing for all of
3 our products. Now, our zinc products can be --
4 can and are assayed at the end for the amount of
5 zinc in them, but we have master batch records and
6 we do have release testing for all the products.
7 DR. WHYTE: We have time for one more
8 question. Dr. Michele?
9 DR. MICHELE: Thank you. So you
10 mentioned pharmacovigilance efforts. I was
11 wondering if you could elaborate a bit on what's
12 involved in those efforts and how and when you
13 might report adverse advents that you've observed
14 through those efforts to the FDA?
15 MS. ARNETT: Sure. All of our consumer
16 calls go in to SafetyCall in Minnesota, and once a
17 year we have an independent review, a complete
18 review, of absolutely every call into SafetyCall,
19 and an independent summary report written up, and
20 an evaluation investigation, a multi-step process
21 that takes -- goes down -- and they assign a
22 number of different levels, different numbers to
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1 them in terms of the severity of the incident and
2 classifies them and categorizes them, and then dig
3 even more deeply down to determine if any of the
4 case reports really are an indication or a signal.
5 And we do that on an annual basis.
6 There are no signals, so -- but that's our third
7 party, independent pharmacovigilance efforts.
8 DR. WHYTE: Thank you.
9 MS. ARNETT: Okay.
10 DR. WHYTE: I apologize to my colleagues
11 on the right side of the room who hear a lot of
12 outbursts. That's our Office of Strategic
13 Programs retreat over there, so clearly they're
14 having a lot of good retreating, I guess.
15 So, at this point we'll turn to our next
16 speaker, Allison Teitelbaum, from the National
17 Center for Homeopathy.
18 MS. TEITELBAUMN: Good afternoon. My
19 name is Allison Teitelbaum and I am the Executive
20 Director of the National Center for Homeopathy, or
21 NCH.
22 I am a Public Health Communications
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1 Specialist and have worked for more than a decade
2 with a variety of consumer facing organizations to
3 improve the health and lives of their
4 constituents.
5 Founded in 1974, NCH is a 501.C3, not
6 for profit organization, dedicated to promoting
7 health through homeopathy. We receive less than
8 three percent of our funding from the homeopathic
9 industry.
10 We are primarily a consumer facing
11 organization and provide general information to
12 consumers about homeopathy. We also offer some
13 more in-depth information to homeopathic
14 practitioners, however, the largest portion of our
15 mission is as a consumer facing organization, and
16 providing information to consumers.
17 Today I would like to address questions
18 one and eight as listed in the Federal Register,
19 and I'd like to start with question number one,
20 which is the question about consumer and
21 healthcare practitioner attitudes about
22 homeopathy.
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1 As we know, the homeopathic drug
2 industry has grown tremendously over the last 25
3 years, and there is a large and growing group of
4 consumers interested in exploring ways to care for
5 their health naturally, both at home and under the
6 care of professionals.
7 This interest in natural healthcare and
8 homeopathic products has been mirrored by an
9 increased consumer demand for information about
10 homeopathy, which is reflected in the tremendous
11 growth of the NCH community.
12 For example, over the past 18 months,
13 our supporter base, which is primarily comprised
14 of consumers, has increased by 40%. During that
15 same time period, the number of visits to our
16 website has increased by 300%, and our social
17 media following has increased by 314%.
18 We also maintain an online directory of
19 resources to assist consumers in finding
20 homeopathic practitioners, and its use has risen
21 by 150% in that same time period.
22 Additionally, in 2014, we launched a
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1 free bi-monthly webinar series for consumers
2 addressing basic homeopathic treatment for a
3 variety of self- limiting, acute care health
4 issues, such as coughs and colds, and have so far
5 welcomed more than 8,000 participants throughout
6 the series.
7 Furthermore, our interactions with
8 consumers indicate that consumer attitudes about
9 homeopathic products are very positive. We
10 receive daily testimonials from consumers about
11 how homeopathic remedies have improved their
12 health and lifestyles naturally, gently, safely,
13 and extremely cost effectively.
14 They express to us that they greatly
15 appreciate the opportunity for choice when
16 selecting over the counter remedies to use at
17 home, and when seeking treatment from a healthcare
18 professional.
19 They want the opportunity to make
20 informed decisions about healthcare that suit
21 their lifestyles and health needs, and the
22 accessibility of homeopathic remedies, over the
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1 counter, is a major factor in this level of
2 satisfaction.
3 Now I would like to address question
4 eight about consumer and healthcare providers
5 having adequate information to make informed
6 decisions. As I've already stated, NCH serves an
7 ever growing community of consumers interested in
8 making informed decisions about their healthcare,
9 including the use of homeopathic drug products.
10 We are the homeopathic organization most
11 visible to consumers in the U.S. and we interact
12 with consumers on a daily basis. We have more
13 than 30,000 visits to our website every month, and
14 receive nearly 400 phone and email communications
15 from our constituents each week.
16 In our experience, consumers are able to
17 make informed decisions about purchasing and using
18 homeopathic products, but there is clearly a
19 demand from consumers for more information about
20 homeopathy, as evidenced by the popularity of our
21 webinar series that I mentioned before, and the
22 consumer facing information on our website.
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1 The consumers we interact with are
2 interested in exploring the spectrum of healthcare
3 options available to them and their families.
4 They come to us for information about homeopathy
5 sometimes prior to using homeopathic remedies for
6 the first time, sometimes after having success
7 with homeopathic remedies.
8 In either case they are proactive in
9 seeking our health information and indicate that
10 we are providing them with the information they
11 are looking for.
12 I appreciate the opportunity to
13 participate in this hearing and I thank you for
14 your attention.
15 DR. WHYTE: Thank you. So we have five
16 minutes of questions.
17 DR. LOSTRITTO: Thank you. I appreciate
18 your comment regarding choice, and I'd like to
19 know what your opinion or feeling -- or your
20 organization's feeling on whether further
21 delineation via labeling and other things between
22 - - placement on product shelves and so forth --
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1 between homeopathic products and other products --
2 would that aid choice or hinder choice or hinder
3 choice selection -- proper choice selection, in
4 your opinion?
5 MS. TEITELBAUM: So, to make sure I
6 understand the question correctly, would there
7 need to be further distinction on labeling or
8 packaging so that people know that they're
9 purchasing a homeopathic product versus something
10 else?
11 DR. LOSTRITTO: Correct.
12 MS. TEITELBAUM: Okay. Well, I think to
13 echo the sentiment of the previous speaker, when
14 we talk to consumers and the people who are coming
15 to us for information, what they want is relief
16 from their symptoms, and they definitely want to
17 know -- you know, if they've seen that there's a
18 product labeled as homeopathic, or they've heard
19 of something that's homeopathic that can be
20 effective, that some of them want more
21 information.
22 But in terms of going into a store and
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1 making a decision about what product to choose,
2 what they're really looking for is something
3 that's going to relieve their symptoms, and so, to
4 them, at the time of making that decision, some
5 may be well informed about what product it is
6 they're choosing as homeopathic, but in the end,
7 what they want is relief and once they see that
8 relief, whether it be from a traditional
9 medication or from a homeopathic product, then
10 they may go back and purchase it again.
11 At that point, they may come to us for
12 additional information, saying, "Hey, this product
13 worked for me. I want to learn more about what
14 this is."
15 But, you know, in terms of them feeling
16 like they're able to make that decision, I don't
17 think that there needs to be further delineation
18 on packaging.
19 DR. WHYTE: Okay. Well, thank you. Our
20 next speaker is Janine Jagger from the Familial
21 Mediterranean Fever Foundation.
22 MS. JAGGER: Thank you. I really
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1 appreciate this opportunity to provide some input
2 on the medications provided by the homeopathic
3 practitioners.
4 I'm Janine Jagger, and I have no
5 conflict of interest, either financial or
6 otherwise. I am President of the Familial
7 Mediterranean Fever Foundation. I am also a
8 Professor of Medicine at the University of
9 Virginia.
10 The FMF Foundation represents patients
11 with a genetic inflammatory disease that, if
12 untreated, involves extreme pain in various forms.
13 FMF is life threatening for certain patients who
14 develop amyloidosis. Amyloidosis can be fatal,
15 but is preventable with treatment.
16 The discovery of colchicine -- Latin
17 term, colchicum autumnale -- as an effective anti-
18 inflammatory treatment for FMF, was introduced in
19 1972 and has saved thousands of lives of FMF
20 patients worldwide, and has dramatically eased the
21 suffering from extreme forms of pain.
22 Colchicine remains the gold standard of
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1 treatment for FMF worldwide, and is so specific to
2 FMF pathology that a positive response to it is
3 still the single criteria that confirms diagnosis
4 of FMF.
5 Let me state clearly that the efficacy
6 of colchicine has been unequivocally established
7 in a multitude of trials and scientific studies.
8 The dosage and drug interactions and safety
9 perimeters have been well established in the peer
10 review medical literature.
11 Unfortunately, over the counter
12 homeopathic products sold in the U.S. pose a
13 serious threat to patients with FMF. Over the
14 counter homeopathic products labeled, "colchicum
15 autumnale" in pill form are sold in the U.S. and
16 health food stores, and online.
17 There are multiple products available
18 with various homeopathic dilutions of colchicum
19 autumnale indicated as active ingredients on the
20 label. The various dilutions found in these
21 products include, in their terms, 6c, 9c, 12c,
22 15c, 30c, 200ck, 1 in 10, and 4x, 6x, 16x, 30x.
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1 All of these dilutions, according to homeopathic
2 theory, are purported to have different
3 therapeutic effects.
4 FMF patients see these products in
5 health food stores and believe that because the
6 label says, "colchicum autumnale," that these
7 products are an over the counter form of
8 colchicine, when in fact there is no therapeutic
9 colchicine in these products.
10 Clearly, the individuals who purchase
11 homeopathic colchicine do not know that, number
12 one, they are foregoing actual colchicine
13 treatment by taking homeopathic preparation of
14 colchicum autumnale. And two, homeopathic theory
15 is based on "like treats like," such that
16 conforming to the tenants of homeopathy, an anti-
17 inflammatory substance is the opposite of the
18 substance that would treat an inflammatory
19 condition.
20 Clearly, products are not being
21 purchased because patients understand and are
22 conforming to the theory of homeopathy. They see
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1 a product with a name on the label and they assume
2 they are buying that product.
3 FMF patients must be informed with an
4 explicit label warning of the danger of
5 substituting homeopathic colchicum autumnale for
6 FDA regulated colchicine.
7 There's a complacency about the
8 consequences when consumers take nothing in place
9 of a drug that has been proven effective, because
10 it's believed that nothing has no side effects and
11 no toxic dose, but I wish to make clear, in the
12 case of FMF, a genetic inflammatory disease, that
13 substituting nothing for prescription colchicine
14 is a very serious -- is very serious for the
15 patient who is deprived of a well documented,
16 effective, and life saving therapy.
17 When an FMF patient chooses homeopathic
18 colchicum autumnale over colchicine, they replace
19 an effective treatment with a deceptive illusion
20 of treatment.
21 The purveyors of homeopathic products
22 depend on the ignorance of consumers to maximize
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1 sales. When consumers do not understand the
2 homeopathic theory of "like treats like," they
3 simply select products by the name on the label.
4 I would ask that the FDA provide very
5 explicit labels to avoid this kind of mistake by
6 consumers. Thank you.
7 DR. WHYTE: Dr. Michele?
8 DR. MICHELE: Thank you so much for that
9 presentation. I'm just wondering if you are aware
10 of any adverse events in terms of disease
11 (inaudible,) of patients with Familial
12 Mediterranean Fever, who have taken the
13 homeopathic product in lieu of prescription
14 colchicine, and if so, if any of those have been
15 reported to the FDA on our MedWatch (ph) program?
16 MS. JAGGER: Um, the incidents that have
17 brought this to my attention have been cases where
18 patients have discussed purchasing this
19 homeopathic colchicum autumnale. In those cases,
20 I have very quickly told them that they are not
21 taking colchicine, so fortunately there's been no
22 long term -- that I know of -- no long term effect
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1 among patients -- discussing this matter in
2 patient forums.
3 However, whether this has occurred among
4 patients who do not bring this to the patient
5 community, I do not know. It's a question of
6 avoiding a serious potential consequence that
7 concerns me.
8 MR. PACE: You indicated that there was
9 some consumer confusion. Do you have any specific
10 recommendations for FDA to ensure that people have
11 adequate information to make an informed decision?
12 MS. JAGGER: Well, certainly in the case
13 of colchicum autumnale, there should be a warning
14 that this is not a product that should be taken
15 for the treatment of Familial Mediterranean Fever.
16 And I think that, you know, in cases
17 where there is a, you know, physician, as the
18 person here described before -- prescribing his
19 homeopathic medication in which they actually know
20 what the real treatment is -- and they prescribe
21 the appropriate treatment.
22 Under those conditions, this situation
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1 can be avoided. It's over the counter, where you
2 just pick what you see off the shelf, that leads
3 to this circumstance. I think there needs to be
4 true medical professional discrimination among
5 homeopathic products, and clinically demonstrated
6 and accepted treatments.
7 DR. LOSTRITTO: Hi. Thank you for
8 pointing out this very important problem. Maybe
9 you mentioned it and perhaps I missed it -- can
10 you give some indication of the scope of this
11 problem and the depth of it in terms of number of
12 patients and what outcomes occurred?
13 MS. JAGGER: Well, Familial
14 Mediterranean Fever is a rare disease, so there
15 are few cases of this disease at all -- so the
16 numbers are not large for a rare disease.
17 However, what I wish to say is to
18 provide an example of that, giving nothing in
19 place of an actual treatment is not necessarily
20 harmless, and I wish to demonstrate that with the
21 situation of Familial Mediterranean Fever.
22 But also, I have a responsibility to
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1 provide beneficial advice to the patients who have
2 FMF, and I would like to have help from the FDA.
3 I have to explain this over and over and over to
4 patients. "Don't take colchicum autumnale in
5 homeopathic preparation in place of colchicine."
6 And there are cases that I'll never have
7 the chance to explain that to, and unless there is
8 regulation or an explicit label on the product,
9 patients have no way of knowing.
10 DR. LOSTRITTO: Thank you.
11 DR. WHYTE: Next we have a trio of
12 panelists. I'm not sure how this is going to
13 work. I guess you will all be speaking
14 sequentially, or will you be speaking --
15 MR. LAND: Yes, sequentially.
16 DR. WHYTE: -- concurrently? I don't
17 know. So, we have Mark Land, Mark Phillips, and
18 Eric Foxman, from the American Assosication of
19 Homeopathic Pharmacists.
20 MR. LAND: Thank you. Good afternoon.
21 My name is Mark Land and I am presenting today in
22 my capacity as President of the American
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1 Association of Homeopathic Pharmacists.
2 I'm also a member of the Homeopathic
3 Pharmacopeia Commission of the United States. I
4 am Vice President of Operations and Regulatory
5 Affairs, (inaudible,) a manufacturer of
6 homeopathic drugs, and I've been in this industry
7 for 35 years with a focus on regulatory policy for
8 non prescription drugs.
9 I'd like to thank FDA for organizing
10 this hearing and for the opportunity to provide
11 information regarding the regulatory framework for
12 homeopathic drugs in the United States. I am
13 joined today by Eric Foxman and Mark Phillips,
14 also of the AAHP.
15 The AAHP is a leading trade association
16 for the homeopathic industry as has represented
17 U.S. manufacturers of homeopathic drugs since
18 1923. Our 29 members manufacture 90% of the
19 homeopathic drug products sold in the United
20 States.
21 The first operating principle of the
22 AAHP's mission statement is to encourage
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1 regulatory compliance among our members. Our
2 dedication to regulatory compliance underscores
3 AAHP's commitment to partner with FDA in its
4 healthcare mission.
5 As part of our regulatory compliance
6 mission, AAHP sponsors an education program
7 entitled Compliance Through Education, delivered
8 via webinars, seminars, white papers, and
9 technical articles. The goals of this program is
10 to inform audiences about compliance, regulatory
11 developments, and scientific information related
12 to homeopathic drugs.
13 These educational efforts reach members
14 and non members alike and amplify FDA's messages
15 regarding regulatory compliance.
16 The current compliance policy guide
17 conditions under which homeopathic drugs may be
18 marketed was developed collaboratively with FDA
19 officials. Discussions between FDA and industry
20 yielded a regulatory framework with a record of
21 effectiveness and efficiency guiding the work of
22 the industry and providing FDA with broad
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1 enforcement authority to protect and promote
2 public health.
3 For many years following the
4 implementation of the CPG, FDA had a point person
5 for issues regarding homeopathic drugs. This led
6 to proactive, two-way dialogue. FDA was an
7 information source for the AAHP, and AAHP made FDA
8 aware of potentially misbranded products.
9 At this time, AAHP recommends that FDA
10 and industry dedicate resources to work to
11 facilitate ongoing communications on homeopathic
12 issues. Safety is a hallmark of homeopathic
13 drugs. I would like to reinforce a few points --
14 important points made earlier in other
15 presentations today.
16 First, the term "exposure" is not
17 synonymous with adverse event. We also learned
18 from Dr. Krenzelok that total exposures to
19 homeopathic drugs in a given year are less than
20 one percent of all reports for pharmaceutical
21 products to poison centers. The rate of exposures
22 is generally below the rate of market share for
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1 homeopathic drugs in the United States. We are
2 not aware of any evidence suggesting safety
3 concerns for homeopathic drugs at this time.
4 In addition, like all pharmaceutical
5 drug products, labelers of homeopathic drugs are
6 required to report serious adverse events to FDA's
7 MedWatch program, and do so. FDA routinely
8 inspects our pharmicovigilence systems as well.
9 The size of the homeopathic industry in
10 the United States is subject to debate. FDA
11 reported three billion dollars annually in the
12 Federal Register announcement for this hearing,
13 however, AAHP estimates the market size to be
14 between eight hundred million and one billion
15 dollars based on commercial sales information
16 sources.
17 What is not in debate is the industry is
18 growing at a rate that closely follows the growth
19 of non prescription drugs in general. Similarly,
20 new product introductions are projected at less
21 than five percent per year.
22 At this time, I would like to answer
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1 some questions -- the questions specifically asked
2 by FDA in the Federal Register announcements for
3 this hearing.
4 Question one, what are consumer and
5 healthcare provider attitudes towards homeopathic
6 drugs? Consumers most likely to buy homeopathic
7 drugs are committed to their health and devote
8 considerable research effort in evaluating their
9 healthcare choices. Many consumers buy
10 homeopathic drugs based on the advice of
11 healthcare providers, friends, family members, and
12 internet research.
13 An online survey, a consumer survey,
14 shows advice from family and health related
15 websites were the primary sources of information
16 about homeopathic drugs, followed by doctors,
17 friends, magazines, and pharmacists.
18 Turning to healthcare professionals,
19 attitudes -- attitudes -- today, as many as 20,000
20 physicians incorporate homeopathic drugs into
21 their daily practice. Physicians rely on
22 manufacturers to produce high quality drugs when
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1 treating their patients, and physicians welcome
2 label information, such as warnings, to inform
3 consumers of signs of disease progression.
4 Question two, what data sources can be
5 identified and shared with FDA regarding risk
6 benefits of homeopathic drugs?
7 In addition to the Poison Center data
8 that we've talked about, the AAHP recommends that
9 the FDA look to websites, regulatory authorities
10 in ICH regions, as well as a number of homeopathic
11 organizations, for information regarding risks and
12 benefits for homeopathic drugs. These include the
13 AAHP's website, the Homeopathic Pharmacopeia
14 Commission of the United States, and the American
15 Institute for Homeopathy.
16 Moving to question three, are current
17 enforcement policies under the CPG appropriate to
18 protect public health?
19 The current compliance policy guide has
20 a successful 25 year record of providing FDA with
21 broad enforcement authority in industry with
22 appropriate guidance. Importantly, the CPG
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1 supports FDA's actions against misbranded
2 products.
3 Over the last ten years FDA has issued
4 43 general, non GNP, warning letters, often citing
5 misbranding due to non-OTC indications in
6 combinations of homeopathic and non homeopathic
7 ingredients. In all these misbranding letters,
8 FDA found adequate support within the CPG to
9 advance its arguments.
10 The FDA has taken swift and
11 comprehensive action when necessary to address
12 problem products in the marketplace with the
13 support of the CPG.
14 Homeopathic drugs are manufactured in
15 facilities registered with FDA and routinely
16 inspected by FDA. The current compliance policy
17 guide is working and is effective. AAHP
18 recommends that FDA maintain existing surveillance
19 and enforcement activities.
20 Question four, are there areas of the
21 current CPG that could benefit from additional
22 clarity?
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1 Although the current compliance policy
2 guide speaks at length regarding the indications
3 for use in prescription versus OTC status,
4 industry lacks clarity regarding the range of
5 symptoms, indications for use, and therapeutic
6 categories amenable to self diagnosis and
7 treatment. AAHP recommends that FDA engage
8 homeopathic medical experts in this area.
9 Question five, is there information
10 regarding the regulation of homeopathic products
11 in other countries that could inform FDA's
12 thinking in this area?
13 Homeopathic drugs are regulated as drugs
14 in most countries. In regions where premarket
15 authorization is required, regulatory authorities
16 require market authorization application dossiers
17 adapted to the unique nature of homeopathic drugs.
18 In European Union, application dossiers
19 are based on the CTD format. In general, market
20 authorization is granted based on the quality and
21 safety information, and efficacy information found
22 in the homeopathic literature.
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1 Premarket authorization processes are
2 resource intensive for regulatory authorities, and
3 backlogs of more than three years are common in
4 Europe. Individual premarket approval regimes are
5 burdensome, long, and costly, to both FDA and
6 industry.
7 What would be the appropriate regulatory
8 process for evaluating such indications for use?
9 The vast majority of homeopathic drugs, or drug
10 products, are appropriately labeled in compliance
11 with HPIS guidelines and FDA regulations.
12 Branded products at retail generally
13 fall into therapeutic categories established by
14 FDA through the OTC review, as amenable to self
15 diagnosis and treatment by lay persons.
16 AAHP supports FDA regarding responsible
17 labeling of OTC products, and we have acted
18 against mislabeled products and in support of FDA
19 action against OTC homeopathic products labeled
20 for the treatment of serious medical conditions,
21 including asthma and diabetes.
22 The AAHP supports enforcement action by
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1 FDA directed against these types of products. At
2 AAHP, we believe the Agency's current regulatory
3 approach embodied in the CPG is in fact the
4 appropriate approach for this regulatory process.
5 Throughout the world, the homeopathic
6 literature is generally the standard used by
7 regulatory bodies when evaluating homeopathic
8 drugs. We believe the current approach is the
9 shortest access to safe, high quality, and cost
10 effective drugs to consumers who want the choice
11 for homeopathic drugs.
12 At this time, I would like to turn the
13 presentation over to Eric Foxman, Secretary of the
14 AAHP, to provide more information regarding
15 question seven.
16 MR. FOXMAN: Thank you, Mark. I'm Eric
17 Foxman. I'm a licensed Pharmacist, and have been
18 for over 35 years. I'm on the Board of the
19 American Association of Homeopathic Pharmacists,
20 and have been so for over half of that time.
21 I'm also a member of the HPCUS, and I
22 provide consulting services to people who are
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1 interested in homeopathic drug products.
2 Thank you for giving me this opportunity
3 to address one of the specific issues raised by
4 the Agency. I will address FDA's question posed
5 in its Federal Register notice. What processes do
6 companies currently use to evaluate whether their
7 products, including indications, are appropriate
8 for marketing as an OTC drug?
9 To respond to this question, the AAHP
10 surveyed its membership. The survey shows that
11 the AAHP member firms follow a deliberate approach
12 when developing OTC indications. The majority
13 looked to FDA's tentative and final monographs
14 when establishing indications for use.
15 Let's take a look at this survey. It
16 was fielded just a few weeks ago in preparation
17 for this particular hearing. Twenty eight
18 companies, 97% of the voting membership of the
19 AAHP, responded to the survey. As Mr. Land has
20 already previously noted, we estimate this to be
21 approximately 90% of the OTC homeopathic market.
22 The first questions were simple "yes"
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1 and "no" questions to gauge the applicability of
2 the more detailed following questions. Of the
3 respondents, all but two companies market and
4 label products as OTC homeopathic drug products.
5 Those particular two exceptions market no
6 homeopathic products under their own label, they
7 only manufacture for other companies.
8 All of the respondents indicate that the
9 OTC products they manufacture or market meet the
10 guidelines for safe OTC attenuation levels found
11 in the HPUS. Approximately two thirds of the
12 respondents use the wording in the FDA's OTC
13 final, or tentative final monographs, as a guide
14 when evaluating label indications for their OTC
15 homeopathic drug products.
16 Several companies indicated that the
17 wording in the monographs is sometimes slightly
18 modified or simplified, without changing the
19 meaning, in order to meet label space constraints.
20 The balance of our survey consisted of
21 open ended questions to ascertain the methods or
22 processes used to determine that products are
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1 appropriate for OTC sale.
2 Respondents reported using an average of
3 four different methods to make their evaluations.
4 These methods include the use of indications,
5 which meet the definition in the Agency's
6 compliance policy guide for products that may be
7 marketed OTC. In other words, quote, "self-
8 limiting disease conditions amenable to self-
9 diagnosis;" comparison with non homeopathic or
10 allopathic OTC products that are presently
11 available in the U.S. market; review of warning
12 letters issued by the Agency to the wider
13 pharmaceutical and dietary supplement industry;
14 close adherence to indications listed in the
15 homeopathic literature when evaluating their OTC
16 label wording; and adherence to HPUS guidelines.
17 I need to take a little moment and point
18 out that this 21% adherence to HPUS guidelines
19 needs to be viewed in conjunction with the prior
20 question that revealed 100% compliance with HPUS
21 safe OTC attenuation levels.
22 These particular responses refer to the
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1 HPUS labeling guidelines, which in terms of OTC or
2 RX labeling, simply cross reference to existing
3 21CFR regulations. A redraft of that document has
4 recently completed its public comment period, but
5 it provides no additional information or
6 distinction regarding OTC indications. It merely
7 provides more detailed information.
8 Members take a number of additional
9 steps when considering the marketing of OTC
10 products. These include review of published
11 clinical, scientific, experience, and trials
12 information, consumer insight, and market research
13 surveys, toxicity studies or reviews, including
14 adverse event reporting, marketing authorization
15 for similar products in other countries, internal
16 formal corporate review and claim study, and legal
17 review.
18 The results clearly show that our
19 respondents are aware of the boundary between OTC
20 and prescription only indications. They make use
21 of both internal and independent outside
22 information sources when evaluating label
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1 indications, and they adhere to the guidelines
2 published in the HPUS and are guided by the OTC
3 monograph process.
4 The vast majority of homeopathic OTC
5 drug products are appropriately labeled in
6 compliance with both FDA regulations as published
7 in the CFR, and with the HPUS.
8 The AAHP wants to emphasize that
9 homeopathic drug products, those which are
10 intended for indications clearly requiring medical
11 intervention, but which are mislabeled as OTC
12 homeopathic drug products -- these products are
13 outlier products. The AAHP supports enforcement
14 action by the Agency, under the CPG, directed
15 against these outlier products.
16 I now turn the podium to Dr. Phillips
17 who will provide information on the final question
18 posed by the Agency.
19 DR. PHILLIPS: Thank you, Eric. My name
20 is Mark Phillips. I have been a licensed
21 Pharmacist for 35 years, focusing on the
22 manufacture of homeopathic drugs and consumer
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1 education on the use of homeopathic drugs.
2 I am presenting today in my capacity as
3 a Board Director of the American Association of
4 Homeopathic Pharmacists. I am a member of HPCUS,
5 and Vice Chairman of Standard Homeopathic Company
6 and Hyland's, a manufacturer of homeopathic drugs
7 in the United States since 1903.
8 FDA's final question centered on
9 information needed to make informed decisions
10 about homeopathic products. The current
11 compliance policy guide provides significant
12 guidance for labelers of homeopathic drugs, as
13 product labeling is pivotal to adequately inform
14 consumers.
15 Homeopathic drug products found at
16 retail are labeled with four cardinal categories
17 of information, including ingredients, uses,
18 directions for use, and warnings. Label
19 information is clearly presented in drug facts
20 format. The AAHP and HPUS labeling guidelines
21 require that products bear the words "
22 {homeopathic" or "homeopathic medicines."
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1 In August of 2012, to better inform
2 consumers about the homeopathic nature of these
3 products, the AAHP adopted revisions to its
4 longstanding advertising guideline. The revisions
5 require consumer advertising for an OTC
6 homeopathic drug to include, "These statements
7 have not been reviewed by the Food and Drug
8 Administration." The Association also urges
9 members to use the same wording on labels and
10 labeling. This was based on the disclaimer
11 enacted by Congress as part of the Dietary
12 Supplement Health and Education Act.
13 The advertising and labeling disclaimer
14 has been widely adopted by AAHP members and
15 appears on increasing number of ads and on labels
16 as existing packages sell through.
17 In addition to this important
18 information, I find that manufacturers are
19 increasing consumer access to pharmacists, nurses,
20 and other healthcare professionals trained in
21 homeopathic pharmacy to respond to their questions
22 through various mediums such as toll free consumer
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1 hotlines.
2 Poison Control Centers are also
3 increasing the breadth and depth of their
4 resources to provide information to consumers and
5 healthcare professionals, such as with the
6 expansion of homeopathic drug listings in the
7 poison deck system database.
8 Labeling is adequate to properly inform
9 consumers as they compare homeopathic as well as
10 allopathic OTC drug options to self-diagnose and
11 self-treat their self-limiting conditions,
12 including warnings when to discontinue use and
13 contract their healthcare practitioner.
14 Manufacturers serve their consumers by
15 making available an abundance of homeopathic drug
16 information. Consumers are able to understand
17 and make informed decisions about their healthcare
18 choices from this information.
19 Mr. Land will conclude for AAHP. Mr.
20 Land?
21 MR. LAND: Thank you, Mark. In
22 conclusion, I would like to reinforce a few
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1 points.
2 First, the Compliance Policy Guide
3 enjoys a record of success and continues to be a
4 workable platform for the regulation of
5 homeopathic drugs in the United States.
6 Homeopathic drugs are of high quality and labeled
7 clearly for consumer and healthcare provider use.
8 And finally, I would like to reiterate
9 AAHP's commitment, as the leading trade
10 association for the homeopathic drug industry, to
11 partner with FDA in its goal for protecting public
12 health. Thank you, and I would be glad to answer
13 any questions.
14 DR. WHYTE: Well, thank you, gentlemen.
15 I'm not sure how -- I'll let you guys decide how -
16 - who will answer what question -- and we'll start
17 the questions. Let's start again -- well, all
18 right, since you had your hand up, let's start
19 with Skip. Maybe we'll start with Skip and then
20 we'll move to Kate, and then we'll go down that
21 way.
22 MR. WU: Okay. Thank you very much for
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1 the nice presentation. I have a question
2 regarding the -- how the manufacturer ensures the
3 high quality of the product? This is also because
4 we are in the botanical team.
5 So, for some of the products, probably
6 the raw material comes from different plants or
7 botanicals. How do you control, you know, the
8 quality of these material used?
9 MR. PHILLIPS: Thank you for your
10 question. Homeopathic manufacturers manufacture
11 in accordance with CFR's and GMP's, just like any
12 other drug manufacturer.
13 We're manufacturing from ingredients in
14 the USP, as well as in the Homeopathic
15 Pharmacopeia of the United States. Within the
16 Homeopathic Pharmacopeia, there are experts that
17 look at starting materials as well as tinctures,
18 and identify identification tests, and where
19 necessary, assays to evaluate both quality and the
20 safety of the medicines.
21 MR. WU: Thank you.
22 DR. BENT: I have a similar type of
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1 question perhaps for Mr. Land and Mr. Foxman.
2 You both noted that your members produce
3 90% of the products. What percent of producers
4 are members, and are there differences in how
5 member and non members enforce, or ensure that
6 there's consistent safety and quality of their
7 materials, and are there difference in the
8 information available to you and your organization
9 about those practices?
10 MR. LAND: We represent 90% of the
11 products made or sold at retail in the United
12 States. That's our estimate based on what we
13 know, and based -- even with a certain uncertainty
14 factor that we added into the potentials that we
15 don't know about.
16 And we represent 29 manufacturing firms.
17 We have 35 members in total. We anticipate that
18 there are somewhere between 50 and 80 marketers of
19 homeopathic medicines in the United States, so
20 while we are 90% of the volume, we're slightly
21 less than 50% in terms of number, but those
22 remaining 50% represent 10% of the products sold
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1 in the United States.
2 We are reasonably sure that our members
3 commit to the policies of the AAHP. They
4 certainly benefit from our educational efforts.
5 Not only the efforts that I mentioned in terms of
6 educational outreach, but they also have an
7 opportunity to phone in and ask questions specific
8 -- that are of specific nature to their firm --
9 which we respond to with our scientific team.
10 With respect to other firms, I can't
11 speak to firms that are not part of the AAHP. I
12 can't speak to -- in exact terms -- to what the
13 quality of their products are, however, I, as a
14 person who surveys my local CVS from time to time
15 and observes what homeopathic products are there -
16 - I'm not often troubled by what I see there in
17 terms of mislabeled products or products of
18 suspect quality.
19 MR. NELSON: Thanks. Throughout your
20 presentation you mentioned reliance on the OTC
21 monograph for indication and the like, and I'd
22 like to just explore, or give you an opportunity
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1 to explore a bit, the depth of your reliance on
2 the OTC monograph.
3 If FDA did decide through rulemaking,
4 which would have to be the process, to make
5 revisions in one or more monographs that impacted
6 on the homeopathic products, would you also say
7 that those homeopathic products ought to be held
8 to those same changes and those same standards?
9 MR. LAND: Uh, the same changes --
10 standards -- as if to say the -- if FDA was to
11 make modifications to an OTC monograph, in terms
12 of warnings or indications for use, or one of
13 those perimeters, we -- I'll speak personally, but
14 I think I speak for Mark and Eric as well -- I
15 personally look at the OTC review and the data
16 that's found there, to be information that has
17 been developed over many years of experience on
18 the part of industry and FDA, and it is an
19 extremely valuable source of information for
20 labelers of over the counter medicines in general.
21 And to the extent that those monographs
22 would be changed, I think that that would be a
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1 very important piece of information for labelers
2 of homeopathic medicines as well.
3 MR. PACE: You stated in your
4 presentation that the definition of a homeopathic
5 drug needs clarification. So, one, why do you
6 think that? And two, how could it better be
7 defined?
8 MR. LAND: I specifically -- in the
9 slide, what I was referring to was the combination
10 of homeopathic active ingredients and in
11 combination with other ingredients or active
12 ingredients, and I think some of our presenters
13 earlier today spoke to the same thing.
14 And, there is a -- there are
15 opportunities to make combinations of products,
16 including homeopathic active ingredients, that I
17 think were not anticipated by the CPG when it was
18 developed, and it probably would be best I the
19 definition was amended to refer to those
20 particular conditions or address them in writing
21 so that it would be clear for labelers of our
22 products.
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1 MS. LIPPMANN: On that same slide you
2 suggest that there's a lack of clarity on the
3 range of symptoms, indications, and therapeutic
4 categories amenable to self-diagnosis and self-
5 treatment.
6 Are you saying that you would like FDA
7 to weigh in more on appropriate uses of
8 homeopathic products, and if so, how would you
9 foresee us doing that short of determining safety
10 and efficacy through an approval process?
11 MR. LAND: Uh, I think that we have
12 1,295 individual active ingredients included in
13 the Homeopathic Pharmacopeia of the United States,
14 and those ingredients can be used for a wide
15 variety of indications, as you can imagine.
16 The OTC Drug Review today, when we
17 include the original monographs, the tentative and
18 final monographs, as well as those substances or
19 those categories that have been created by OTC
20 switch, is about 80 categories.
21 There are probably -- within the
22 (inaudible) of Homeopathic Drugs, there are
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1 categories that could be addressed on a self
2 medication basis that are outside of those 80
3 categories.
4 MS. LIPPMANN: And one more quick
5 question. On an earlier slide you say that
6 consumers that are most likely to buy homeopathic
7 medicines do considerable research. Do you have
8 data to support that? And also what do you
9 consider to be considerable research?
10 MR. LAND: The data that I'm referring
11 to was a study that was actually performed by my
12 company several years ago, which was seeking to
13 identify the habits of consumers who are
14 interested in buying homeopathic medicines, and we
15 found in our research that those folks that are
16 most likely to buy these products tend to be very
17 active in their health.
18 They tend to be constantly looking for
19 new ways to promote their own health, and
20 therefore by nature, they're researching all the
21 time.
22 If I think about my wife, she goes to
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1 the store and she buys something off the shelf
2 that she was -- either her mother bought, or that
3 she discovered when she was in the store. That
4 would be -- I would term "0" research versus
5 someone who goes to a WebMD website and maybe
6 looks for opportunity -- or looks for information
7 regarding a particular medical product or a
8 particular medical condition. Maybe that's a
9 medium range.
10 And someone who actively engages in
11 alternative approaches, or multiple approaches to
12 treating a condition, that would probably be a
13 consumer that's more likely to use a homeopathic
14 medicine.
15 DR. LOSTRITTO: Thank you. I want to
16 shift gears a little bit and focus on new product
17 development that you touched on, and specifically,
18 is the CPG enough? So I've been waiting for some
19 pharmacists to come up here, and this may be the
20 only group of pharmacists we actually see today.
21 In terms of new product development, you
22 know it's possible to completely follow GNP, end
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1 up with a failed product, if development preceding
2 that hasn't been done scientifically and
3 effectively.
4 Specifically, when developing a new
5 product, what sorts of protocols do you take into
6 account to make sure that the dilutions are going
7 to be accurate, because some of these materials
8 can be surface active, they can absorb the glass,
9 they are normally manufacturing losses, and these
10 can be substantial in either under or overloading
11 a specific dilution with an amount of material,
12 and I'm just curious if you can summarize briefly
13 what do during development to ensure that you have
14 that quality aspect controlled?
15 MR. LAND: Well, I think that -- I'll
16 speak from maybe the experience of my own company.
17 We -- first of all, generally manufacture products
18 in dosage forms that we are familiar with, so
19 we're not going to novel an exotic dosage form,
20 and that serves the purpose of simplicity and
21 economics as well.
22 So, we're working with dosage forms and
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1 formulations that we're familiar with. We
2 formulate based on general principles of
3 formulation for drug products in general, and we
4 test and we validate based on pilot scale and then
5 industrial scale batches to make sure that we're
6 yielding the product that we anticipate, and
7 that's proven through finished product testing as
8 well as in process testing.
9 As far as the individual technique for
10 dilution is concerned, that process is also
11 validated and depending on the exact nature of the
12 processes being undertaken, it may involve the
13 original starting material or it may involve
14 surrogates.
15 DR. WHYTE: Thank you. So we are just a
16 minute behind schedule. The agenda has us
17 concluding at 2:25. It is 2:26. We will resume
18 in 15 minutes, so please come back at that time.
19 Thank you.
20 (Off the record at approximately 2:15
21 p.m.)
22 (Recess.)
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1 (Back on the record at approximately
2 2:25 p.m.)
3 DR. WHYTE: Okay. We're coming along
4 the home stretch. Our next speaker is Barbara
5 Kochanowski from the Consumer Healthcare Products
6 Association.
7 MS. KOCHANOWSKI: Thank you and good
8 afternoon. I'm Barbara Kochanowski, Vice
9 President of Regulatory and Scientific Affairs for
10 the Consumer Healthcare Products Association.
11 CHPA is the trade association
12 representing the manufacturers of over the counter
13 medicines and dietary supplements. We have more
14 than 80 manufacturer members and about 10% of
15 these market homeopathic medicines.
16 Our members include both branded and
17 private label companies, large and small, publicly
18 held and privately held. What brings them
19 together is a shared commitment to strengthen the
20 industry through science education and advocacy.
21 Today I'll be addressing four of the
22 questions FDA posed in the announcement for this
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1 meeting. I'll share some consumer data and
2 insights regarding OTC medicines, including
3 homeopathic products. I'll also comment on the
4 safety of homeopathic products and the current
5 regulatory framework.
6 Seen through a consumers eyes, a broad
7 range of products are helpful as people take care
8 of their own health needs. Consumers site many
9 reasons for OTC healthcare product usage,
10 including 24/7 availability, greater control of
11 their health, and cost savings.
12 Americans demand a range of options
13 among products used to self treat their health
14 conditions. Why? Individual preference for
15 ingredients, dose forms, and formulations vary.
16 We see individual variability in
17 response to treatments. Some medicines in a
18 product category may be contra indicated for
19 certain populations, while others are not.
20 All of these factors can lead to
21 differences in satisfaction with available
22 treatment options. Research shows consumers
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1 report very responsible attitudes towards OTC
2 medicines. Most take an active role in their
3 healthcare. They are confident in their ability
4 to use OTC medicines and know that the medicines
5 work for them.
6 And, most U.S. adults are comfortable
7 treating minor illnesses before seeking
8 professional care. In fact, they prefer self
9 treatment.
10 FDA has two questions about consumer
11 knowledge and attitudes about homeopathic
12 medicines. CHPA recently conducted some consumer
13 research to better understand consumer knowledge
14 about homeopathic products.
15 This was a telephone survey among 1,000
16 U.S. adults. We'll share the full results in our
17 written comments as they came in after the slides
18 were prepared. Key findings include that
19 consumers demand a range of treatment options.
20 Seventy-four percent of those surveyed agree that
21 when making a decision about what products to buy
22 to treat their conditions, they would like even
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1 more options, and 79% of consumers agree that
2 finding a product that works for them means they
3 need multiple choices.
4 When asked about familiarity with
5 homeopathic products, one quarter of respondents
6 were extremely or very familiar. One quarter were
7 somewhat familiar, and one half were a little or
8 not familiar. Thirty-eight percent of the
9 respondents said they had tried homeopathic
10 products, and not surprisingly, those who were
11 most familiar with homeopathic products were the
12 most frequent users.
13 Doctors and online websites are by far
14 the major sources of information about medical
15 treatments, with doctors being seen as the source
16 of the most reliable information.
17 We know from many research studies that
18 consumers shop by indications and the symptoms
19 they intend to treat. As such, it's unlikely that
20 consumers look specifically -- or that most
21 consumers look specifically -- for homeopathic
22 products, but rather look for products that give
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1 them a range of choices to treat their symptoms.
2 CHPA strives to provide consumers with
3 accurate information about all OTC medicines. Our
4 consumer facing website under the label of
5 KnowYourOTCs.org is one source of information for
6 consumers about OTC medicines, including
7 homeopathic products.
8 CHPA is also hosting a webinar, upcoming
9 soon, on homeopathy, with a focus on regulations
10 and compliance. This is available to our members
11 and non members. This material will be archived
12 for future viewing if anyone is interested in the
13 topic.
14 FDA asked about data sources to better
15 understand homeopathic products. The American
16 Association of Poison Control Centers, NPDS (ph)
17 database is one such source.
18 Dr. Krenzelok has already spoken about
19 these data earlier today, which covered the span
20 of 2006 to 2013. That research was funded by
21 CHPA. The data show that homeopathic products have
22 a very favorable safety profile, with low overall
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1 exposures, and with low or no health effects. As
2 is the case with all medicines, though, there's an
3 opportunity to reduce accidental and intentional
4 exposures.
5 And as a follow-up, I don't think it was
6 stated earlier -- Rocky Mountain Poison Center is
7 going to be purchasing the additional case level
8 data that they'll be able to do a much more in
9 depth analysis of the case reported in that data
10 system, and that report, we hope to be able to
11 submit by the June 22nd deadline. But regardless,
12 they will be doing that.
13 CHPA supports the regulatory framework
14 for homeopathic drug products, which are regulated
15 in many ways like allopathic OTC drugs. We
16 believe that the FDA compliance policy guide has
17 been successful in supporting FDA's public health
18 mission, and appreciate the opportunity to work
19 with FDA in reviewing it.
20 Homeopathic drugs have been subject to
21 regulation under the federal FTNC Act since 1938.
22 Manufacturers of homeopathic medicines are subject
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1 to routine inspections, and the CPG requires
2 manufacturers to register with the FDA and list
3 their drug products.
4 Controls like CGMP's serious adverse
5 event reporting, standardized labeling, and
6 compendia standards, are all in place to assure
7 quality and safe use.
8 In summary, to the consumer, homeopathic
9 medicines are one segment of OTC medicines.
10 Consumers see great value in OTC medicines for
11 treating minor ailments because they provide cost
12 effective, accessible solutions to self treatable
13 conditions.
14 Consumers demand a range of choices to
15 treat their conditions, and they select OTC
16 medicines based on indication and symptoms, not on
17 regulatory classification. Nearly 40% of
18 consumers report having tried homeopathic
19 medicines, and homeopathic products have a very
20 favorable safety profile.
21 The current regulatory framework meets
22 the needs of consumer access and ensures standards
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1 of quality and safety by homeopathic drug
2 manufacturers. Where products are not following
3 the CPG, FDA has the ability to act and to act
4 swiftly.
5 I thank the FDA for this opportunity to
6 present on behalf of our members.
7 DR. WHYTE: Thank you, Barbara. Barbara
8 noted she was here one of my first days I started,
9 so she said she was glad that I'm still here, so
10 thank you. Thank you, Barbara.
11 So, maybe we'll start the five minutes
12 of questions and we -- Kate just put -- at the
13 last minute. We'll start with Kate.
14 DR. BENT: Can you clarify what you mean
15 about standardized labeling? It's on your
16 slide 11.
17 MS. KOCHANOWSKI: I think you heard form
18 Mark Phillips. I'm not quite sure of the last
19 speaker, but he talked about having the
20 ingredients -- the warnings -- the drug facts type
21 labeling for categorization of the different
22 elements of a label on homeopathic medicines.
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1 DR. BENT: And are the label dilutions
2 standardized?
3 MS. KOCHANOWSKI: I'm sorry, I don't
4 know.
5 MS. LIPPMANN: Can you elaborate a bit
6 on what you believe to be the understanding that
7 consumers have about homeopathy and what it is?
8 So, for example, not just that a product
9 is homeopathic, but do they understand the issue
10 of dilutions and that there might not be any trace
11 of a pharmacologically active ingredient.
12 MS. KOCHANOWSKI: Good question. Our
13 research that we did very quickly in preparation for
14 the hearing was really the first opportunity we've
15 had to talk to consumers at all about homeopathic
16 products in recent times, and we gave a short
17 definition of homeopathic products as part of the
18 survey.
19 So when you see about 40% of consumers
20 responded they had tried them, they at least had
21 some information that we provided in the survey,
22 but we didn't do anything other than that to probe
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1 their knowledge level.
2 MS. LIPPMANN: So you don't know, for
3 example, if they understand homeopathy to be
4 different or the same as natural medicine, say?
5 MS. KOCHANOWSKI: We didn't test that in
6 the survey.
7 MS. LIPPMANN: Thanks.
8 DR. LOSTRITTO: I'm going to follow up
9 on that. Your organization deals with a number of
10 consumer healthcare products, and I assume your
11 organization has an interest as part of its
12 mission to facilitate choice through education and
13 clarity of labeling.
14 Having said that, what do you see as the
15 balance between labeling delineation by different
16 types -- I've been discussing here five
17 medicinals, RX, OT switches, um, homeopathic
18 products.
19 Product placement, labeling, and how you
20 would use that -- how do you envision that -- to
21 optimize choice of the right thing that the
22 patient is seeking?
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1 MS. KOCHANOWSKI: That's probably the
2 million dollar question, isn't it? That's a great
3 question, and I think what we're hearing at the
4 meeting is that there are opportunities to
5 potentially clarify labeling, but first to better
6 understand what consumers are actually looking
7 for, and how they're reading those labels.
8 All of our research, historically, has
9 shown they shop by symptoms, and they're looking
10 to treat a certain condition. Beyond that, we
11 need to answer some of those questions to be able
12 to say, "Does it make sense to change anything?"
13 MR. PACE: With respect to abuses of the
14 CPG, can you comment on whether you're aware of
15 firms or instances where firms may be using the
16 CPG to market a product as homeopathic when they
17 don't -- maybe not -- when they maybe don't need
18 an OTC monograph, or otherwise be legally
19 marketed.
20 MS. KOCHANOWSKI: You know, I think you
21 heard the former group talk about the outliers.
22 I'm not aware of any specific examples, and we
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1 would certainly not support that.
2 DR. WHYTE: Any other questions? All
3 right. We'll welcome now Peggy O'Mara to the
4 podium.
5 MS. O'MARA: How much can I do with
6 this? Okay. I'm short. All right. Let me get
7 this out of here. I'm sorry.
8 My name is Peggy O'Mara. Good afternoon
9 everyone -- and I have no financial interest
10 related to this hearing.
11 As an award winning journalist, I have
12 been covering natural family living for over 30
13 years. I was the editor and publisher of
14 Mothering Magazine from 1980 to 2011, and in 1995,
15 I founded Mothering.com, the largest online
16 community of naturally minded parents. In 2013, I
17 founded PeggyOMara.com, where I continue to cover
18 family health.
19 In these roles, I possess a broad
20 knowledge of consumer attitudes toward and use of
21 homeopathic products, especially as related to
22 pregnancy, birth, and child care.
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1 I serve on the advisory boards of
2 Attachment Parenting International, Best for
3 Babes, Holistic Mom's Network, Infant Massage
4 U.S.A., Intact American, and Oak Meadow. I'm a
5 mother of four adult children, and the grandmother
6 of three.
7 My own introduction in homeopathy
8 occurred in the early 1980's when as the editor of
9 Mothering Magazine I published an article by a
10 homeopathic physician. Soon thereafter I visited
11 a homeopathic pharmacy to look for over the
12 counter drugs to sooth the minor illnesses of my
13 four children.
14 As a natural living pioneer, I sought
15 out alternative healthcare for my family, not only
16 because of my inclination, but also because I am
17 of the first generation of parents to become aware
18 of the potential overuse of antibiotics.
19 Today I will address FDA's questions;
20 number one, about consumer attitudes, and number
21 eight about labeling.
22 I'll begin with question number one. In
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1 the early 2000's, Whole Foods Market did an
2 internal survey and determined it is women who buy
3 the majority of their products, both for
4 themselves and for their families, and that women
5 first become interested in natural products when
6 they start a family.
7 As new mothers, women become more
8 concerned about they put into their bodies and
9 what they put into their children's bodies. They
10 look for safe and gentle products and their
11 concerns lead them to become consumers of
12 homeopathy.
13 Homeopathic consumers respect allopathic
14 medicine, but not all symptoms require a visit to
15 the doctor's office or a prescription.
16 When I was the mother of four young
17 children, I wanted effective and affordable
18 products to sooth my children's minor ailments and
19 support their healing. Like young parents of
20 today, when I look for over the counter products,
21 I want ones that are not only pure and safe, but
22 also accessible and easy to use.
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1 There are several reasons that consumers
2 choose homeopathic products, and the first is that
3 homeopathic products are affordable. The cost,
4 for example, ranges from $7.00 to $15.00, and
5 homeopathic products are easily available online
6 at many websites, including Amazon.com, as well at
7 local natural grocery stores and pharmacies.
8 Mother's also find homeopathic drugs easy to use
9 because children like their taste and do not
10 resist taking them.
11 Certainly, the biggest reason that
12 parents use homeopathic products is because they
13 work. Young mothers of today, including my
14 daughter and my daughter-in-law, have great
15 enthusiasm for homeopathic teething tablets, for
16 example, and their use has steadily grown in
17 recent years through word of mouth.
18 Mothers recommend them to each other,
19 simply because they work so well. Mother's want
20 safe and gentle products. They worry when they
21 hear about product recalls of over the counter
22 cough and cold medicines for children, and many
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1 look to homeopathy as an alternative because they
2 trust homeopathic products to be safe and
3 effective and gentle.
4 Parents also look to homeopathy as a
5 safe and gentle first line of defense for upper
6 respiratory illnesses -- for upper respiratory
7 illnesses in their children, and they want to be
8 prudent about giving their children antibiotics
9 unless absolutely necessary.
10 Over the last several decades there has
11 been a profound shift in the ways consumers
12 participate in their healthcare. They are
13 increasingly taking a proactive and holistic
14 approach to health and wellness. In fact, the
15 concepts of health and healthcare are moving
16 toward the notion of personalized health
17 maintenance.
18 Consumers of homeopathy are interested
19 in this kind of participatory medicine because it
20 increases their sense of self-determination, and
21 by example, their children's.
22 As a young woman, I read the book,
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1 Homeopathic Medicine at Home, and through its use
2 became a better mother because I began to observe
3 the symptoms of my children in a more
4 comprehensive way.
5 For example, before I read the book I
6 thought that a cough was just a cough, but
7 homeopathy has taught me that there are many
8 different types of coughs, and in wanting to
9 differentiate between them I believe I have become
10 a better mother and more helpful to my children
11 because I provided them an example of home self
12 care -- of home self care that they have continued
13 with their own families.
14 U.S. Consumer's use of homeopathic
15 medicine has also been influenced by the fact that
16 we have become a world community. U.S. parents
17 know what parents in other countries are doing and
18 it gives them confidence to try new things.
19 They are influenced by the fact that
20 62.5% of French mothers use homeopathic drugs and
21 practice -- and pediatric homeopathy is very
22 popular, both in Germany, and in France, and in
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1 other parts of Europe. Because of their
2 fascination with Princess Kate Middleton, young
3 mothers in the U.S. are intrigued when they hear
4 that England's royal family has been using
5 homeopathy for generations.
6 Apparently, mothers all over the world
7 use homeopathic drugs to sooth their children's
8 acute conditions like colds, coughs, flu, fevers,
9 and teething. They find them helpful for minor
10 sports injuries, for occasional sleeplessness and
11 anxiety, for over stimulation, seasonal allergies,
12 and other every day ailments.
13 In addition, the internet has made it
14 easy for mothers to get information about
15 homeopathy. Mothering.com is the premiere website
16 for natural family living, and with over 240,000
17 members, the largest online community for
18 naturally minded parents.
19 On Mothering.com, for example, there are
20 over 100 links to articles and discussion threads
21 about homeopathy, and discussion threads include
22 conversations about homeopathy for ailments like
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1 morning sickness, teething, growing pains, cough,
2 sleeplessness, colds, nasal congestion, and fever,
3 among others.
4 As the Editor and Publisher of Mothering
5 Magazine for over 30 years, I have witnessed the
6 evolution of homeopathy from alternative medicine,
7 to complimentary medicine, to integrative
8 medicine.
9 When I was a young parent, there were no
10 health food stores or natural food grocery stores,
11 so we made our own alternative products. Today,
12 natural and organic food is the fastest growing
13 sector of the American food economy, and every
14 year the natural and organics product industry
15 grows in double digits. Along with natural
16 products and natural food, homeopathy has become
17 mainstream.
18 Next, I would like to address FDA's
19 question number eight. I find the labeling on
20 homeopathic products to be adequate. I appreciate
21 that the label lists the uses for the remedy
22 because it expands my knowledge, and in fact, I
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1 usually go into a store looking for a specific
2 remedy I have researched myself.
3 In my opinion, gaps in adequate product
4 information exists within some medical practices,
5 but not at the retail level, for the consumers. I
6 would appreciate it allopathic and other
7 healthcare practitioners were more versed in
8 homeopathy, because it is often an excellent
9 compliment to their care.
10 For example, I would have welcomed
11 recommendations for homeopathic drugs to ease my
12 pain when I recently had x-rays and follow-up
13 physical therapy for arthritis.
14 In conclusion, many consumers today are
15 interested in self care and leading a toxic free
16 lifestyle, so they look for a repertoire of
17 natural products to bring relief to themselves and
18 their loved ones. Parents want safe, effective,
19 affordable, and easily accessible products for
20 everyday ailments, and homeopathic products
21 provide this.
22 I hope that your deliberations will
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1 result in the continued ease of access to
2 homeopathy that three generations of my family,
3 and thousands of my readers and online community
4 members have enjoyed. Thank you very much for the
5 opportunity to speak to you today.
6 DR. WHYTE: Thank you, Peggy, for
7 sharing your story. I didn't think we'd hear
8 about Kate Middleton today.
9 MS. O'MARA: I had to throw her in.
10 She's very --
11 DR. WHYTE: That was interesting. I
12 forgot my question on her, but okay. So let's see
13 if the panelists have any questions. And Daddy's
14 care about safe medicines, too, so -- it's always
15 Mommy, Mommy, Mommy. Okay. All right. Let's --
16 yeah, Mommy and Me classes. There's Daddy and Me,
17 too. Okay. I have a young child at home.
18 (Laughter.)
19 DR. WHYTE: Any questions?
20 (No audible response.)
21 DR. WHYTE: All right. Well, thank you,
22 Peggy.
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1 MS. O'MARA: Thanks.
2 DR. WHYTE: All right. Next, we're
3 going to have Luana Colloca. Did I say your name
4 correctly? Colloca. I apologize. From
5 University of Maryland in Baltimore.
6 DR. COLLOCA: Good afternoon. I would
7 like to thank the FDA for the invitation, and it
8 is -- okay, a little bit about me. I am a
9 physician with a PhD in neuroscience and a
10 Master's in bioethics, and during the last two
11 decades I was working on mechanismal (ph) placebo
12 effects.
13 Today we were talking several times
14 about placebo effects, but never were mentioned
15 the mechanism that aligned this phenomenon, so
16 that is a great opportunity for me to show our --
17 it's important to see that expectancy, motivation,
18 and the placebo mechanism when we take into
19 account any interventions.
20 So, the goal will be to show a little
21 bit of neurobiology related to this mechanism, how
22 important clinically to consider if placebo
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1 effects, and finally discuss with you the
2 legitimacy of intervention that may work by virtue
3 of a placebo mechanism.
4 So, placebo. A placebo, per se, is a
5 term that comes from the Bible. Placebo
6 (inaudible) -- from Latin -- and the translation
7 means "I shall (inaudible.)"
8 But it's very important to distinguish
9 between placebo effects and placebo responses.
10 Placebo effects are related to a neurobiological -
11 - a clinically relevant phenomenon -- and we are
12 able to distinguish between placebo effects and
13 placebo responses when we have a (inaudible.)
14 So a placebo effect will be something different
15 from bias, a regulation to the mean, naturally
16 studied, co-intervention, and so on. Conversely,
17 the placebo response per se can be related to all
18 of these effects together because we don't have a
19 (inaudible.)
20 So, just to summarize, this is an example where we
21 are able to see that a proportion of any benefit
22 we observe in clinic can be related to different
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1 phenomenon and just a little bit of this benefit
2 eventually is related to placebo effects. And the
3 magnitude of this kind of phenomenon varies
4 tremendously across different conditions and
5 disease.
6 So, it's very important to consider that
7 when we talk about placebo effects we are not
8 talking about effects of sugar pills or saline
9 solution. Every time we use an intervention,
10 there is a placebo component related to the
11 (inaudible) and the (inaudible) around any
12 patient, and it's interesting that any time we use
13 an intervention that is conventional or
14 alternative, we have the combination of both the
15 effects.
16 And that is an example where we show
17 that -- for example, for pain, it's interesting
18 that any time we experience relief, this kind of
19 relief is derived by specific pharmecodenomic (ph)
20 component, and some other component that I call
21 here, expectancy driven effects.
22 And just an example, I was still
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1 (inaudible) the student, and we start to use this
2 model where morphine was delivered through a
3 different way. (Inaudible) administration versus
4 open administration. For (inaudible)
5 administration, you can see from the cartoon we
6 use a pump of infusion to (inaudible) deliver
7 morphine.
8 Conversely, for the open administration,
9 the patient would inform about the time of
10 delivering of our medication, and you can see from
11 these results that even the effects of morphine
12 changed dramatically when we use an (inaudible)
13 versus open administration.
14 So, we measure pain, in this case, in
15 patient in post-operative surgery, and we use a
16 medical rating scale, and you can see the broken
17 line shows the time of administration for ten
18 milligrams of morphine to manage post operative
19 pain.
20 In blue, I show the effects of an open-
21 administration of morphine. In red, the
22 (inaudible) administration of morphine. The
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1 difference in exactly the same dose of morphine is
2 related to expectancy and placebo effects.
3 It's also interesting that this
4 phenomenon -- it's true in the opposite way.
5 Where was negative expectancy driving adverse
6 event, or less if (inaudible) issues the drug.
7 So, in fact, when we look at morphine --
8 and in this case we showed interruption of
9 morphine by informing our patient, now we are
10 stopping, in blue, you can see that there is an
11 increase of pain.
12 Conversely, when we interrupt morphine
13 but patients are not aware about this because the
14 interruption was managed by a computer, there is
15 no change in pain perception. That is the power
16 of expectancy in managing our perception of
17 symptom like pain.
18 And this kind of effects are not true
19 only for morphine, we explored open administration
20 of different kind of pain killers. You can see
21 that both opiods and non-opiods, like (inaudible,)
22 tramadone (ph,) catorelcok(ph,) metamisone (ph,)
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1 are very strongly modulated by expectancy.
2 Again, in green we show the open
3 administration where there is the combination of
4 both the component, pharmocodenomic (ph) specific
5 component, plus placebo effects. And in red, when
6 the same dose was managed by a pump of infusion --
7 so we, in the lab or in the clinical setting,
8 silent expectancy.
9 It's also interesting that words, per
10 se, can modulate the perception of the symptoms.
11 In this case, women at term of their pregnancy and
12 ready for delivery were treated with epidural
13 anesthesia, and they were informed differently
14 during the procedure.
15 Randomization, through two different
16 disclosures -- group one was told, "You are going
17 to feel a big, big sting. This is the worst part
18 of the procedure." Group two was told, "We are
19 going to give you a local anesthetic that will
20 numb the area and you will be comfortable during
21 the procedure."
22 So, group two, slightly differently
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1 informed, you can see that there is a positive
2 component, an anticipation of the benefit related
3 to the administration of the anesthetic drug. And
4 in this case, when a blind clinician was entering
5 into the room and assessed the pain related to the
6 procedure, you can see that group two reports an
7 experience of less pain.
8 So, based on this observation, we
9 suggested to educate any practitioners and
10 patients about the possible effects of placebo
11 processes, but also tailoring the information
12 delivery process to the needs of the patient, and
13 frame the disclosure processes, and pay attention
14 to any kind of information we deliver to our
15 patient.
16 But, the goal of this part (inaudible) -
17 - who was first let you know that placebo effects
18 depend upon the activation of specific
19 physiological mechanisms, but most importantly for
20 today, I think that this kind of research may
21 provide a hint to reconsider the efficacy of any
22 intervention and treatment that may work primarily
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1 by placebo mechanisms.
2 And, you know, as we assess the
3 (inaudible) treatment, any kind of treatment, and
4 the question is, if an intervention lacks specific
5 efficacy, is it still appropriate to recommend it
6 in daily clinical practice?
7 And I'm not talking very much about
8 homeopathy, but I want to present three different
9 examples to show how placebo effects can be
10 relevant and our interest is to think about
11 efficacy based on this knowledge.
12 Let's start with supplemental.
13 Supplemental derives from (inaudible) -- and it's
14 mostly used to treat symptoms related to benign
15 (inaudible.) So, when we compare the effects of
16 this alternative treatment with conventional
17 treatment in a large population -- in this case
18 the researcher compared Saw Palmetto with
19 finasteride, and you can see that there is very
20 compatible efficacy for both of the treatments as
21 was when compared supplemental with tamsulosin.
22 So, when we look at cost, supplemental costs much
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1 less than both the conventional treatment.
2 And let's provide another example. Non-
3 invasive vertebroplasty -- for those of you who
4 are not familiar with the procedure, that is a
5 surgery that is suggested for a patient with
6 osteoporosis and pain related to fracture in the
7 spine.
8 So, interestingly, there have been
9 published very interesting paper related to this
10 procedure and I will show to you that they include
11 a sham (ph) surgery. So the sham surgery consists
12 in exactly the same procedure, but without
13 injecting (inaudible.)
14 The goal was to try to understand if
15 vertebroplasty per se can modulate pain perception
16 and manage pain over time.
17 Interestingly, two randomized clinical
18 trials published in New England Journal of
19 Medicine and one open label trial published in
20 Lancent show no difference between sham and true
21 surgery, but with is important, both are very good
22 in managing pain and report improvement of the
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1 pain measured at the time point. So, the question
2 is then, is it acceptable to recommend this
3 intervention based on what we have learned through
4 the clinical trial?
5 So, in this case, we can look at the
6 risk benefit cost to provide. In (inaudible) --
7 there are no complications related to the sham
8 surgery, and both groups show the same occurrence
9 of adverse events like fractures. In terms of the
10 benefit, both true and sham vertebroplasty reduced
11 pain in patients. In terms of cost, patients
12 treated with vertebroplasty gained on average 120
13 pain free days.
14 Now, a little bit of homeopathy. Is the
15 benefit of homeopathy a placebo effect? Well,
16 today we have learned a lot about this with
17 comprehensive talk about current knowledge. I
18 just would like to show two (inaudible) and to
19 review a delayed metanalysis (ph) actually. It
20 related to homeopathy.
21 The one published about ten years ago in
22 Lancet that we discussed already today show that
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1 large trials of higher quality, the observation
2 for homeopathy was 0.88 as compared to 0.58 for
3 conventional medicine.
4 However, if we look in a sort of
5 condition where the expectancy are quite small
6 because of the intrinsic nature of, you know,
7 these averages included in the metanalysis, like
8 animals, there was no robust evidence that
9 homeopathy is distinguishable from placebo
10 effects.
11 Therefore, there are at least three
12 questions of interest. At interventions, working
13 by virtue of placebo responses or effects,
14 clinically and medically acceptable, should the
15 clinician or any other health practitioner
16 recommend these interventions in addition, but not
17 instead of, conventional treatment.
18 If intervention with equal efficacy, and
19 usual care are not given, do we deprive our
20 patients of potential benefit?
21 They suggest three answers, but I'm open
22 to discuss with you -- it is acceptable to
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1 recommend an intervention with clear favorable
2 risk/benefit to cost/provide. In terms of
3 professional integrity, it may remain a potential
4 conflict of interest to the principle of evidence
5 based medicine, and ultimately patients deserve to
6 be informed about our current knowledge, and
7 eventually any lack of specific efficacy and a
8 potential for a specific placebo responses.
9 And I would like to thank you for your
10 attention, and those who are interested to learn
11 more about the neurobiology related to placebo
12 effects, we published during the last two years
13 these three books.
14 DR. WHYTE: Thank you very much, and
15 we'll start with our questions.
16 DR. LOSTRITTO: Thank you very much. I
17 have two questions. I think they're relatively
18 quick.
19 One, on the open versus the closed
20 administration of an analgesic, do you know if
21 there was a difference in healthcare contact at
22 the patient's bedside in the closed versus the
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1 open, or the hidden versus the open?
2 DR. COLLOCA: We didn't enforce exactly
3 the same amount of healthcare contact before the
4 treatment, but of course there is a difference
5 when we have the open scenario, where of course a
6 physician or a nurse informs the patient, and the
7 psychosocial context around the patient is then
8 researched.
9 However, this study has been duplicated
10 with (inaudible) and in this case normal
11 participants were receiving the (inaudible) with
12 open and even administration of the same drug, and
13 it's interesting that there is a different
14 modulation of a specific area of the brain related
15 to being aware of receiving the treatment versus
16 not.
17 DR. LOSTRITTO: You also showed some
18 very interesting examples of sham surgery versus,
19 you know, real surgery, and so forth, and you sort
20 of stopped short in your presentation. I'm going
21 to ask you to go a step further.
22 Are you implying, either implicitly or
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1 explicitly, that the placebo effect is the
2 operative mechanism for homeopathy, and if so, can
3 you explain where your conclusion is drawn from?
4 DR. COLLOCA: Sure. I have to do my
5 disclosure. I didn't do research with homeopathy.
6 What I did was a search of the literature to learn
7 more about this phenomenon.
8 But today we are talking, and in
9 general, people who work in this field know that
10 expectancy and motivation of a patient are
11 relevant, and my research and other colleagues who
12 work in this field show our expectancy can really
13 produce neurobiological change.
14 So, I expect that, like for surgery or
15 alternative treatment, tests for less conventional
16 medicine like morphine or (inaudible,) there must
17 be a placebo component, and I expect that this
18 placebo component is quite strong.
19 So, to be careful in addressing the
20 question that I tried to skip -- is homeopathy an
21 example of a placebo effect? It can be, but it's
22 very important to understand in which this is,
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1 which condition, and eventually to try to take
2 into account patient expectation and motivation.
3 DR. WHYTE: Dr. Nelson?
4 DR. NELSON: I'm going to take a risk
5 here. This may sound more like a comment than a
6 question, but I'll ask you to comment on my
7 comment then as the question.
8 I'm struck by the language that we're
9 all using in different ways. So, natural and
10 homeopathic, at times, seems to be lumped
11 together. I'm not surprised. If you look at the
12 history of the development of allopathic
13 medications, a lot of them come from natural
14 products. Digitalis would be a good example.
15 And so I'd -- you know, the Saw Palmetto
16 example is not surprising to me necessarily. I
17 wasn't aware of that research, and then I decided
18 since I'm sitting here with my laptop to Google
19 Saw Palmetto and homeopathy, and up comes -- and I
20 have no idea if this is reputable -- "mother
21 tincture, ten to 30 drops, third potency often
22 better for precisely the treatment of benign
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1 prosthetic hypertrophy."
2 And so, I guess, you know, these
3 categories -- we seem to be using them in
4 different ways that are often in my mind not clear
5 if we're being precise, and that bothers me.
6 You know, there is -- the reason we pick
7 -- I mean, a placebo is meant to be an inert
8 substance so I'm sitting here thinking, well, what
9 would be the placebo for a homeopathic trial?
10 Would it be, you know, the mother tincture?
11 DR. COLLOCA: A solution without any
12 component.
13 DR. LOSTRITTO: No, I -- well, but I
14 don't know what it is, and so that -- it would
15 really have to be specific. It's just -- I guess
16 the terminology -- I'm beginning to feel that
17 we're being a bit loose when we talk about natural
18 versus homeopathic versus allopathic.
19 We really need to be much more specific
20 in those details, and I guess I -- whatever
21 comment you have on my comment.
22 DR. COLLOCA: I can comment on this and
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1 say that from an epistemological -- you know,
2 toxonimy (ph) point of view, it's always helpful
3 to have very clear determination, but that is not
4 necessarily always easy.
5 And, from my perspective, homeopathy is
6 a good case where it's possible to understand the
7 placebo component quite well because, as compared
8 to other procedures like vertebroplasy or some
9 other more difficult intervention to -- you know,
10 in terms of cost or in terms of (inaudible) to
11 control.
12 Homeopathy, at least, I represent a case
13 where it is possible to study the placebo
14 component, and I agree with you that it's always
15 good to talk good terminology to try to narrow the
16 limits of research and knowledge.
17 DR. WHYTE: Kate, did you have a
18 question?
19 DR. BENT: I do. One of your concluding
20 remarks addressed transparency in communication
21 with patients about specific efficacy and
22 unspecific responses.
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1 So, are you aware of research that looks
2 at healthcare patient communication specifically
3 around placebo or around expectancy, and around
4 health literacy in homeopathic --
5 DR. COLLOCA: I had the opportunity to
6 work on this -- work on placebo effects and
7 ethical aspects when I was at NIH.
8 We were running a lot of research
9 looking at how disclosure can drive (inaudible) --
10 as well can drive adverse events and placebo
11 effects, and I really want to emphasize the need
12 to explain transparently to patients, you know,
13 our knowledge, and eventually the lack of
14 knowledge sometimes.
15 And, of course, this may create a sort
16 of reassessment of their expectancy, but I think
17 it's ethically and really important to inform
18 patients so that they can make a good decision and
19 progress.
20 DR. WHYTE: Thank you. Okay. Next we
21 will hear from Alyssa Wostrel from the Integrative
22 Health Policy Consortium.
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1 MS. WOSTREL: Thank you, Dr. Whyte and
2 panalists. Thank you for the opportunity to speak
3 today. My name is Alyssa Wostrel and I am the
4 Executive Director of the Integrative Health
5 Policy Consortium, or IHPC.
6 As background, IHPC is a national non-
7 profit, 501-C4, created in 2001 as requested by
8 Congressional members who saw a consensus voice in
9 complementary and integrative healthcare for
10 legislators, policy makers, and federal agencies.
11 Our mission is to advocate for an
12 integrative healthcare system with equal access to
13 the full range of health oriented, person
14 centered, regulated healthcare professionals.
15 IHPC represents 16 organizations and
16 educational institutions, over 400,000 licensed
17 and certified providers, including chiropractors,
18 acupuncturists, holistic nurses, certified
19 professional midwives, massage therapists,
20 naturopathic physicians, and conventional
21 physicians trained in integrative practice.
22 They provide clinical care services to
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1 millions of Americans each year. IHPC is here to
2 assure safety and quality in complementary
3 alternative medicine. With assured safety and
4 quality we expand the effective choices for
5 doctors and patients in healthcare.
6 Now, a quick word about my background.
7 Prior to joining IHPC as Executive Director, I
8 served as an Executive and a consultant with
9 several homeopathic manufacturing companies. I
10 interacted with thousands of licensed
11 practitioners who used homeopathic products for
12 their patients regarding product use and medical
13 education programming.
14 I coordinated with quality assurance and
15 quality control departments to assure product
16 labeling compliance with labeling regulations in
17 the compliance policy guide. I always consider
18 the FDA an important guide in promoting the safety
19 of the public health.
20 Today, issues about safety and quality
21 will inform the three key agenda questions that I
22 will address. Safety and quality of homeopathic
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1 products is a constant in our professions. Safety
2 and quality is a focus of advocacy by IHPC. It is
3 through the lens of safety and quality that I
4 deliver my remarks today.
5 To the question, what are consumer and
6 healthcare provider attitudes towards human drug
7 and biological products labeled as homeopathic?
8 IHPC has the following answer; positive consumer
9 attitudes about high quality, safe, homeopathic
10 products, can be seen through quantity and
11 frequency of use.
12 Homeopathic products accounted for an
13 estimated one billion dollars in out of pocket
14 expenditures in the U.S. in 2012, according to
15 research by Mintel (ph.) A 2008 NCAM (ph) survey
16 listed homeopathy in the top ten most utilized CAM
17 therapies.
18 A Stanford study of CAM use among the
19 fastest growing segment of the population found
20 that 5.8 percent of seniors surveyed use
21 homeopathy and experienced greater symptom relief
22 compared to other CAM options. A 2014 survey of
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1 homeopathic patients noted efficacy and safety as
2 the top two, quote, "best liked attributes of
3 homeopathy."
4 Providers that IHPC represents have
5 favorable attitudes toward both availability of
6 homeopathic services through trained and
7 credentialed practitioners and patient access to
8 homeopathic products.
9 These providers incorporate safe, high
10 quality, homeopathy in patient care during
11 consultations, and also for ongoing patient's
12 healthcare. Therefore, access to homeopathic
13 products is important as a therapeutic choice for
14 both the provider and the consumer.
15 Access to the licensed or certified
16 healthcare provider of one's choice is a central
17 tenant of Section 2706, the non discrimination
18 provision of the Affordable Care Act. IHPC
19 advocates for the full implementation of Section
20 2706 through Cover My Care, a consumer facing
21 initiative.
22 The FDA's effective guidance of a
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1 manufacturing, labeling, marketing, and sales of
2 homeopathic products has been in place since 1938.
3 Compliance requires that manufacturers must
4 register with the FDA and are subject to FDA
5 inspections. IHPC fully supports this guidance.
6 The healthcare providers represented by
7 IHPC, who practice homeopathy, and who refer to
8 homeopathic practitioners, understand that
9 individual homeopathic ingredients marketed for
10 sale in the U.S. have been thoroughly reviewed.
11 They have been reviewed for homeopathic
12 efficacy, toxicology, adverse effects, and
13 clinical use, by the Homeopathic Pharmacopeia
14 Convention of the U.S. This informs the attitudes
15 of these providers that utilization of homeopathic
16 products is in accordance with best practices for
17 safety and effectiveness.
18 This rigorous review by HPCUS, guided by
19 the FDA, has been an essential in safety and
20 quality of homeopathic products.
21 My professional experience in this field
22 assures me that the current regulatory system,
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1 based on the FDA compliance policy guide, has been
2 effective for safely regulating homeopathic
3 products.
4 To the question, "What data sources can
5 be identified or shared with FDA so that the
6 Agency can better assess the risks and benefits of
7 drug and biological products labeled as
8 homeopathic?"
9 IHPC has the following answer:
10 References from the World Health
11 Organization and the Swiss Government Report are
12 suggested. Both address similar question to those
13 the FDA is asking in this hearing. Links to
14 documents are provided in our submission.
15 The IHPC can be utilized by the FDA as
16 an information source to engage with the leaders
17 in complimentary and integrative healthcare in the
18 U.S. to access recommendations of data to review.
19 Such an information channel can create a center
20 for FDA discussions with providers about real time
21 safe usage of effective quality products in a
22 clinical or therapeutic setting. IHPC's consumer
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1 based site, Cover My Care, may also provide a
2 similar channel to patient populations.
3 In order to add to the FDA's already
4 substantial understanding of homeopathy, and to
5 foster clarity, the FDA could consider having a
6 homeopathic expert on staff to serve as a liaison
7 with the homeopathic community.
8 And finally, to the questions, "Do
9 consumers and healthcare providers have adequate
10 information to make informed decisions about drug
11 products labeled as homeopathic?" IHPC has the
12 following answer:
13 Regarding healthcare providers, the
14 breadth of licensed and certified providers and
15 their patients who safely use homeopathic products
16 have been well served for many decades. This
17 service is underpinned by the robust educational
18 standards of training, licensing, and certifying
19 bodies, in homeopathic education, and their
20 professional development, symposia, and
21 literature.
22 Licensing and certification boards for
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1 the practice of homeopathy have expressed
2 standards of ethics and informed consent for the
3 education of their clients and patients. It
4 assures the knowledge to make informed decisions.
5 It assures quality care.
6 Consumer educational outreach, as we
7 heard earlier, is the focus of the National Center
8 for Homeopathy, an IHPC member organization as a
9 partner for health, whose 5,000 plus members are
10 informed by a newsletter, magazine, webinars, and
11 annual conferences.
12 Media articles on homeopathic self care
13 are published in reputable wellness journals and
14 online sites, such as Mothering.com, as we just
15 heard, and Yoga Journal.
16 Homeopathic organizations and product
17 manufacturers also provide education and online
18 tools to prepare consumers to make informed
19 choices about homeopathic products for self
20 limiting conditions. Even before the recent new
21 world of consumer driven healthcare, our industry
22 has been educating consumers so they can make
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1 better informed decisions.
2 IHPC's member organizations that
3 represent providers and consumers of homeopathic
4 products are vigilant in ensuring that consumers
5 have safe and clearly identified homeopathic
6 products to choose for their healthcare needs, and
7 access to the providers of their choice.
8 In the end, safe, effective choices for
9 healthcare providers and their patients are about
10 assuring quality, quality products, quality care,
11 quality of life.
12 Thank you for your attention.
13 DR. WHYTE: Thank you.
14 MS. WOSTREL: Thank you.
15 DR. WHYTE: Kate, is that -- okay. All
16 right. Let's start with Kate and then we'll go to
17 Rima, and then we'll go down the row.
18 DR. BENT: Thank you. Can you talk a
19 little bit about what type of information about
20 the manufacturing preparation of any homeopathic
21 products would be of benefit, either to the
22 practitioners in your organization or the
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1 organizations in your organization?
2 MS. WOSTREL: I'm sorry, the
3 manufacturing?
4 DR. BENT: Any information about
5 manufacturing of the product that would be use to
6 the practitioners or to the organizations that you
7 represent?
8 MS. WOSTREL: The first thing that comes
9 to mind, of course, is the American Association of
10 Homeopathic Pharmacists as a resource for that
11 question as well, but we could also, for instance,
12 survey our practitioners of -- 400,000 plus
13 practitioners with those type of questions.
14 DR. IZEM: Hello. I have a question
15 related to your answer to question one. You seem
16 to make a distinction between single -- individual
17 homeopathic ingredient versus many ingredients.
18 Did I understand that correctly, that you have
19 that distinction?
20 And then a related question in response
21 to question two, when you cite sources of data on
22 risk benefit of homeopathic products, would that
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1 be for single ingredients only?
2 MS. WOSTREL: Well, I didn't make a
3 distinction between single or complex homeopathy
4 in my presentation, so we could attempt to address
5 that in our written comments if that would be
6 helpful.
7 DR. IZEM: I guess I was referring to
8 your statement, "We understand that individual
9 homeopathic ingredients marketed for sale in the
10 U.S. have been reviewed for homeopathic efficacy,
11 toxicology, adverse events," etcetera.
12 MS. WOSTREL: Uh-huh.
13 DR. IZEM: So I thought you were making
14 a distinction between one ingredient versus many
15 ingredients, but --
16 MS. WOSTREL: I see. Yes, I -- well, I
17 can certainly understand how that would be the
18 implication, but it's not -- I don't think it's
19 the main point that we were trying to address.
20 MS. MICHELE: You concluded by
21 suggesting that we need clearly identified
22 homeopathic products for consumers to choose, and
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1 I wonder if you could provide your recommendations
2 for how those products should be clearly
3 identified to differentiate them from non
4 homeopathic products?
5 MS. WOSTREL: Well, the label currently
6 is of any homeopathic product -- or products that
7 are labeled correctly, do state that they are
8 homeopathic or that they're labeled as homeopathic
9 medicine. That is appropriate, along with dose
10 information and the indication, so -- am I
11 answering your question?
12 MS. MICHELE: So, just to clarify, you
13 feel that if the product states somewhere on the
14 label that it has homeopathic, then that is
15 adequate labeling?
16 MS. WOSTREL: I think it's adequate
17 labeling to have it in typeface that is large
18 enough for the consumer to understand the
19 differentiation between a conventional OTC, and
20 that this is a homeopathic product.
21 And furthermore, other presenters had
22 indicated, and I agree, and IHPC would also be
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1 comfortable with this position, that more consumer
2 information through the National Center for
3 Homeopathy or other sources -- more consumer
4 information about homeopathy, the distinction of
5 what homeopathy is, will be helpful I think for
6 consumers to make informed choice decisions.
7 MS. MICHELE: So do you feel that should
8 be on the principal display panel, or should it be
9 elsewhere on the product label in the drug facts?
10 Where are you suggesting that that needs to be on
11 the --
12 MS. WOSTREL: No, what I'm saying is I
13 think the labeling, if it's labeled correctly with
14 homeopathic, or as homeopathic medicine, is
15 adequate, but that other sources of information
16 and channels of information for curious consumers,
17 who are wanting to make informed choices, would be
18 helpful.
19 So more of what we are already doing
20 would be helpful to more consumers to make these
21 different choices and to continue making these
22 choices. Thank you.
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1 DR. WHYTE: Dr. Nelson, do you have a
2 comment or --
3 DR. NELSON: A question.
4 DR. WHYTE: A question. Go right ahead.
5 DR. NELSON: I was struck by your phrase
6 "homeopathic efficacy," and so my question is, was
7 that just a turn of phrase as opposed to using
8 efficacy of homeopathic products, or did you mean
9 to imply that there's a different standard for
10 homeopathic versus non homeopathic efficacy?
11 MS. WOSTREL: Right. Thank you for that
12 question. No. I would say that that's in the
13 category of a turn of phrase.
14 DR. WHYTE: Any other questions?
15 (No audible response.)
16 DR. WHYTE: Okay. Well, thank you.
17 Next, I'd like to welcome Nancy Peplinsky from the
18 Holistic Mom's Network. You can say dad's, too.
19 MS. PEPLINSKY: It's dad's, too. I
20 promise you. We have many dad's in Holistic
21 Mom's.
22 Good afternoon. My name is Nancy
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1 Peplinsky, and I'm the founder and Director of the
2 Holistic Mom's Network, which also welcomes dads,
3 a national 501(c)3 non-profit organization
4 connecting parents and others interested in
5 holistic health and green living. We were founded
6 12 years ago and have more than 100 chapters
7 across the United States.
8 I am here today, sponsored by the AAHP,
9 but I am representing myself and the 13,000 highly
10 engaged moms and dads who are members of the
11 Holistic Mom's Network, as well as our more than
12 92,000 social media friends and followers.
13 I am also the mother of two boys who
14 have been raised according to holistic and natural
15 lifestyle options, and prior to my motherhood
16 journey, I worked in academia and also in non-
17 profit organizations here in the D.C. area, and I
18 earned both my second master's and PhD right
19 around the corner from here at the University of
20 Maryland.
21 I was first introduced to homeopathy as
22 a graduate student by a fellow graduate student
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1 who was using homeopathy to treat flu like
2 symptoms, and after I became a mom, I began
3 researching and using homeopathy with my family
4 with great success. That is my brief personal
5 background.
6 And I'd like to turn to a couple of the
7 questions set forth in the Federal Register
8 notice. The first concern I'd like to address is
9 the consumer and healthcare provider attitudes
10 toward homeopathic products.
11 My personal experience with homeopathy
12 is very reflective of the experiences of members
13 of the Holistic Mom's Network across the country.
14 For myself and for many of our members, homeopathy
15 has become one of our primary healthcare
16 modalities for several reasons.
17 First and foremost is safety. The high
18 quality and standards that currently apply to the
19 industry help to ensure that the products are
20 safe, reliable, and effective.
21 My older son has multiple allergies,
22 including those to dairy, soy, gluten, and corn,
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1 and has had severe reactions to some of these
2 ingredients over the past years. Many of these
3 substances are present in conventional medicines
4 and formulas, along with flavorings and coloring,
5 which he is also sensitive to, and make these over
6 the counter medications often unavailable to him
7 for use. Homeopathy gives him a mechanism to
8 treat common conditions, such as colds, seasonal
9 allergies, even bumps and bruises, without the
10 fear of an allergic reaction.
11 Homeopathy is equally important for my
12 younger son who has special needs. He has a
13 number of ongoing issues, and he has a very bad
14 gag reflex as a result of intubation as an infant,
15 and he is unable to swallow a lot of pills or any
16 other medications unless they're in liquid format,
17 which is a little bit hard to get in some cases.
18 Homeopathic remedies give him a simple option for
19 common conditions as well, and helps overcome
20 these issues that he has to deal with and face.
21 Homeopathy works in conjunction with a
22 wide range of conventional integrative therapies
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1 that I use with my family. They are not usually
2 exclusive from conventional medicine, but work
3 powerfully alongside of it.
4 Throughout the Holistic Mom's Network,
5 our members find homeopathic remedies are easy to
6 administer, they're easy to transport and have
7 available, they're easy to give because of their
8 sweet taste for children, and they're very useful,
9 and that they're not contraindicated with other
10 medicines.
11 Like many moms, and as a single mom, I
12 have limited time and a restricted budget. Having
13 access to homeopathic remedies helps empower me to
14 take care of my children effectively and
15 affordably, particularly for a wide range of
16 conditions that do not require prescriptions or a
17 doctor visit.
18 On a broader scale, homeopathy engages
19 parents by making them aware and responsive to
20 their children's symptoms. Homeopathy uses
21 individualized remedies specific to each child and
22 to each symptom, negating a "one size fits all"
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1 approach, and customizing it to your child.
2 In my home, because we use homeopathy,
3 my kids are very in tune with their symptoms and
4 can express them very clearly. When one of my
5 children has an illness or a symptom, sometimes as
6 simple as a headache, we discuss the details of
7 exactly how he is experiencing it, and come up
8 with the best remedy to match his condition.
9 I think over the long term this makes
10 children much more attuned to their symptoms,
11 their bodies, and their physical health, which
12 will serve them over their lifetime.
13 The efficacy, safety, and ease of use
14 are the biggest reasons that homeopathy is so
15 popular throughout the Holistic Mom's Network.
16 Many of us have had tremendous success with
17 homeopathy, especially where conventional
18 therapies were not successful.
19 Both in my personal experience and in
20 the experience of Holistic Moms Network members,
21 indicate that the current oversight labeling and
22 information provided about homeopathic remedies is
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1 adequate for consumers to make informed decisions
2 about the use of homeopathy.
3 Although homeopathy has been around for
4 over 200 years, many people in this country are
5 not familiar with its practice, and as a result,
6 education is a very important aspect of effective
7 use. Organizations like Holistic Moms Network
8 work with doctors of homeopathy to ensure that
9 parents understand the remedies and their uses.
10 To touch on another question posed in
11 the Federal Register, I believe that the
12 standardized packaging and labeling currently in
13 use makes these products very safe, even for the
14 novice consumer. Because the established makers of
15 homeopathic products have very high standards and
16 comply with the current regulations, their safety
17 concerns are very minimal.
18 As the voice of thousands of families
19 across the U.S., I find that parents do an
20 inordinate amount of research and consult with
21 healthcare professionals before using any wellness
22 product, either conventional or holistic.
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1 I am not an expert in the regulatory
2 framework, but the policies and standards that the
3 FDA has provided for homeopathic remedies allows
4 families like mine to access these important
5 medications.
6 I am open to any questions, and thank
7 you for the opportunity to speak.
8 DR. WHYTE: Thank you.
9 DR. LOSTRITTO: Hi. Thank you. It was
10 said earlier today that people select homeopathic
11 products largely by first going and looking at
12 symptoms and then seeing what's available and
13 making a choice from that.
14 I'd like to ask, in your experience,
15 since you're so interested in homeopathy, do you -
16 - when you have a child or a family member with a
17 set of symptoms, do you set out to seek a
18 homeopathic remedy for those symptoms and match
19 it, or do you shop by looking at what treatments
20 are available, say over the counter, for that set
21 of symptoms in the aisle of a pharmacy, and do you
22 see any benefit in segregating products by type,
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1 or by symptom?
2 MS. PEPLINSKY: Forgive me if I'm not
3 clear, but I think whether it's conventional or
4 holistic, most of us go with a set of symptoms in
5 mind. I mean, we definitely we're experiencing
6 flu like symptoms and so we'll go and look for
7 products that deal with that set of symptoms and
8 that protocol.
9 I specifically like to have all of the
10 options available in one place because it's not
11 just homeopathy that we use in our family. We
12 have found homeopathy to be extremely effective,
13 and so we do tend to choose homeopathic products,
14 but I am open to looking at all sorts of products
15 to find out which one is going to seemingly be the
16 best fit, and then also based on the ingredient
17 lists, because for me, as I said, with multiple
18 allergies I have to be very careful about label
19 reading, and so I have to know exactly what's in
20 the products that I'm going to then give to my
21 children.
22 DR. LOSTRITTO: Thank you.
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1 MS. MICHELE: So thank you for sharing
2 your story and that of your sons. Just to follow
3 up on what you heard from Dr. Lostritto, with
4 regards to ensuring that your products that you
5 are purchasing would not have any interaction with
6 your son's allergies, how do you find that for the
7 homeopathic products? How do you ensure that they
8 are not containing any of those elements?
9 MS. PEPLINSKY: Like many parents, I
10 think we take advantage of the wide range of
11 resources that are available to us today.
12 Technology has been a boon for all of us. We can
13 all go online and Google pretty much anything.
14 I like to rely on certain very well
15 established and credible manufacturers of
16 homeopathic remedies and seek out information from
17 them through their websites, through the
18 information ingredients list and product lists on
19 their website as well as even contacting them
20 directly to find out exactly if their products
21 contain any of the allergens that I need to be
22 careful about.
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1 And so I think as a parent, and as many
2 parents, especially with children with allergies,
3 we go through extraordinary lengths to ensure that
4 our children are safe using all of these and we
5 take that upon ourselves to do that.
6 It's always very helpful when a product
7 is labeled "allergen free" and lists that
8 allergens that it's free of. As a parent, I find
9 that incredibly useful, but if I need to go the
10 extra mile, I certainly will.
11 MR. PACE: When a mother or father comes
12 to you and asks what a homeopathic drug is, what
13 do you tell them?
14 MS. PEPLINSKY: I tell them that it's a
15 substance that works from a very small dilution of
16 a substance that works in the principles of "like
17 cures like" because that's how I understand
18 homeopathy in the most simplest form, and that it
19 stimulates a natural immune response to create
20 alleviation of symptoms.
21 That's my most simple explanation that I
22 can do for homeopathy, and I think it works for a
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1 lot of people.
2 DR. WHYTE: Up next we have Tanya Kell
3 from the North American Society of Homeopaths.
4 MS. KELL: Good afternoon. My name is
5 Tanya Kell and I am here in the interest of the
6 public. Neither I nor those whom I represent
7 stand to gain to or lose financially from any
8 outcome of this hearing.
9 I am the President of the North American
10 Society of Homeopaths, as he said, and our
11 professional society of homeopathic practitioners
12 is modeled after the registered society of
13 homeopaths in England.
14 We require extensive training in
15 homeopathy and a broad understanding of its unique
16 principles as well as peer review and adherence to
17 a code of ethics for membership. We are involved
18 in shaping policy, creating educational standards,
19 and protecting the rights of both the homeopathic
20 consumer and provider, nationally and
21 internationally.
22 Our members have specialized knowledge
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1 of homeopathic medicines and inform the public on
2 the use of those medicines according to standard
3 homeopathic indications for each particular
4 potentized (ph) drug.
5 We have a sincere concern for
6 maintaining an accurate and ethical reputation,
7 both for our members and for homeopathy as a
8 whole. It is our desire to aid the Food and Drug
9 Administration in evaluating and identifying the
10 veracity of the word "homeopathic" on any
11 particular drug label.
12 Almost all of the products labeled
13 homeopathic according to the FDA definition of the
14 term, that have generated FDA alerts and warning
15 letters over recent years, were not homeopathic
16 according to the principles of our profession and
17 of accepted homeopathic doctrine. Many of the
18 complaints currently filed under the heading,
19 "homeopathic products," would disappear if all of
20 the erroneous labeling were corrected.
21 It is still possible to enforce a
22 technically correct use of the word on drug
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1 labels, and we believe it is in the best interest
2 of the public to do so.
3 It is up to the FDA to establish, much
4 as the Department of Agriculture did for organic,
5 criteria for accurate label usage of the word
6 "homeopathic."
7 There is a long, established record of
8 both safety and efficacy in homeopathy.
9 Homeopathic practice is based on hundreds of years
10 of clinical experience by both physicians in this
11 country and around the world.
12 The Homeopathic Pharmacopeia of the
13 United States is an accurate document as to the
14 preparation, origins, potencies, of truly
15 homeopathic products.
16 The current regulatory structure is
17 adequate to meet the needs of the consumer, both
18 in assuring product safety and consumer access.
19 However, the homeopathic professions viewpoint
20 must be considered in the regulatory agencies
21 determination of which products are sold to the
22 public as homeopathic.
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1 According to the World Health
2 Organization, homeopathy is the second most widely
3 used form of medicine worldwide. It must remain
4 broadly accessible to an informed American public.
5 Thank you.
6 MR. LOSTRITTO: You make a very
7 passionate statement in the third paragraph. It
8 is up the FDA to establish, as much as the
9 Department of Agriculture did for organic, the
10 criteria for accurate label usage of the word
11 "homeopathic." What's your vision of how that
12 labeling would appear?
13 MS. KELL: That is in reference to the
14 linguistic drift that has been part of the
15 confusion that the word "homeopathic" means
16 natural, and the reputation of homeopathy has been
17 built on the good advice given by skilled,
18 trained, practitioners.
19 And so we want to ensure the good
20 reputation of homeopathy by not allowing that
21 linguistic drift to become entrenched.
22 MR. LOSTRITTO: I agree. As somebody
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1 who is involved in labeling, linguistic drift is
2 the bane of what we try -- of what we do. But can
3 you be specific in how you would remedy that, what
4 you would like to see a label look like?
5 MS. KELL: That's been addressed a
6 little bit by some of the pharmacies. There's a
7 broad range of commonly used remedies that have
8 indications that can be spelled out clearly in a
9 few words, and we have those in our health food
10 stores.
11 There's also -- we have nearly 5,000
12 homeopathic remedies in use around the world, and
13 some of them you can't put a three word
14 description on a small bottle, and we would
15 encourage the use of "use according to standard
16 homeopathic indications," and so that lets people
17 know that they need to consult with someone who
18 has studies in depth.
19 MS. LIPPMANN: A couple of questions,
20 one teeing off of that. Does your definition of
21 homeopathy differ from what you understand FDA's
22 definition to be?
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1 MS. KELL: No. The HPUS defines it
2 pretty well.
3 MS. LIPPMANN: Okay. And you say in -- I
4 guess it's your last paragraph -- that there's a
5 long, established record of both safety and
6 efficacy in homeopathy. Can you provide -- what
7 are the data sources for that long established
8 record, particularly with respect to efficacy.
9 What are you referring to?
10 MS. KELL: This is more a compilation of
11 anecdotal evidence, so when I studies social work
12 that was an accepted form of evidence, is just
13 compiling anecdotal stories.
14 Homeopathy has hundreds of millions of
15 those, and you know, as our reputation grows, so
16 does those anecdotal stories, and we feel that
17 they are a legitimate source of data.
18 MS. LIPPMANN: Okay. Thanks.
19 DR. WHYTE: So, I have some exciting
20 news to share. Our last speaker is not here.
21 That's not exciting. What is exciting is that
22 you're basically getting back 30 minutes of your
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1 day, and we will conclude early.
2 I do have a few closing comments.
3 Everyone will need to sign in again tomorrow, so
4 please be sure to come here a bit early so you
5 have plenty of time to sign in.
6 In case you can't be here and you want
7 to watch it online, again, that website is
8 Collaboration.gov/hprApril2015.
9 And finally, I want to thank everyone on
10 behalf of Dr. Woodcock and myself. I know there's
11 lots of things that you could be doing on a Monday
12 in Silver Spring -- rather than coming to Silver
13 Spring, Maryland in a windowless room that is
14 sometimes hot, for seven and a half, eight hours.
15 So, it's certainly very helpful to hear
16 people's stories, their personal stories, their
17 professional perspectives on this issue.
18 So we know that there are many things
19 that you could be doing with your day and we're
20 very appreciative of the time that you've taken to
21 come today, to stick to the timelines, to be
22 collegial, and we look forward to that tomorrow as
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1 well.
2 (Whereupon, at approximately 3:39 p.m.,
3 the hearing in the above matter was
4 concluded.)
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
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1 CERTIFICATE OF NOTARY PUBLIC
2 I, MICHAEL FARKAS, the officer before whom the
3 foregoing deposition was taken, do hereby certify
4 that the witness whose testimony appears in the
5 foregoing deposition was duly sworn by me; that
6 the testimony of said witness was recorded by me
7 and thereafter reduced to typewriting under my
8 direction; that said deposition is a true record
9 of the testimony given by said witness; that I am
10 neither counsel for, related to, nor employed by
11 any of the parties to the action in which this
12 deposition was taken; and, further, that I am not
13 a relative or employee of any counsel or attorney
14 employed by the parties hereto, nor financially or
15 otherwise interested in the outcome of this
16 action.
17
18
19 ___________________________ MICHAEL FARKAS
20 Notary Public in and for the DISTRICT OF COLUMBIA
21
22
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1 CERTIFICATE OF TRANSCRIPTION
2
3
4 I, ANNMARIE WASKO, hereby certify that I am not
5 the Court Reporter who reported the following
6 proceeding and that I have typed the transcript of
7 this proceeding using the Court Reporter's notes
8 and recordings. The foregoing/attached transcript
9 is a true, correct, and complete transcription of
10 said proceeding.
11
12
13 _____________________ ANNMARIE WASKO
14 Transcriptionist
15
16
17
18
19
20
21
22
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$$10.00 176:5
$15.00 262:4
$20.00 176:6
$50,000.00 176:4
$7.00 262:4
00 245:4
0.58 279:2
0.88 279:2
01 48:18 49:21
11 1:9 19:9 212:22
1% 39:3
1,000 250:15
1,295 243:12
1,500 133:21
1,800 52:6
1:00 175:22
1:10 178:11,14
10 212:22
10% 25:4 239:22248:14
10,311 54:6
10:42 105:18,22
100 39:3 75:1133:18 137:21265:20 301:6
100% 231:20
1061 15:5
10903 1:14
11 88:4 255:16
11,000 138:2
11:00 105:19,21
12 21:19 40:9136:10,13 301:6
12:10 178:9,15
120 278:12
12c 212:21
13 56:6
13,000 301:9
13.3 38:17
131 4:12
15 1:6 12:4,5105:17,20133:20 247:18
150% 205:21
1503(A 1:15
153 4:13
15c 212:22
16 287:15
16th 153:9
16x 212:22
17 4:5
173 4:14
176 41:21
179 4:15
18 205:12
185 138:1
18th 153:9
19 23:10 53:8
19,037,967 21:15
1903 234:7
191 4:16
1923 219:18
1938 42:7 43:12253:21 291:2
1972 43:3 211:19
1974 204:5
1980 259:14
1980's 176:3 260:8
1988 7:22
1990's 160:13
1991 75:7
1994 65:14
1995 176:1 259:14
1997 55:5 65:1271:6 75:21 82:8137:1 161:7
1998 36:10 55:11
1x 49:6 105:10
22,000 133:21
2,000,000 134:1
2:15 247:20
2:25 247:17 248:2
2:26 247:17
20 1:10 23:1041:18 108:13118:8 136:6,9,11
20,000 132:19133:12 223:19
200 306:4
2000 55:15 136:7
2000's 261:1
2001 65:19 287:7
2003 65:18 76:17
2004 157:16 169:2
2006 20:11 252:20
2008 289:15
2009 118:6
200ck 212:22
2011 259:14
2012 36:10 54:4235:1 289:14
2013 20:11 116:12252:20 259:16
2014 82:9 205:22289:22
2015 1:1015:11,14 53:8
203 4:18
20993 1:16
21% 231:18
210 4:19
218 4:20
21CFR 12:5 232:3
22 174:16 175:5,8
225 52:7
22nd 15:11,14253:11
24 19:13 64:2174:21
24/7 249:10
240,000 265:16
248 4:22
25 132:20 133:11205:2 224:20
259 5:1
269 5:2
2706 290:17,20
287 5:4
29 144:6 219:18239:16
2x 39:2 105:10
3
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3,000 78:19
3:39 318:2
30 13:21 14:2 18:849:12 103:21112:4,5 173:9259:12 266:5283:21 316:22
30,000 88:14207:13
30/10 38:9
300% 205:16
301 5:5
30c 103:21 201:2212:22
30x 38:9 212:22
31 1:15
311 5:6
314% 205:17
35 4:7 64:1 219:7228:18 233:21239:17
36 55:8 175:1
3c 49:9
3x 49:8
44,500 108:6
40 176:12 177:12
40% 77:22 137:8205:14 254:17256:19
400 207:14
400,000 287:16296:12
400.00 113:8,17114:13
400.400 138:10,20
192:22
43 225:4
4x 212:22
55,000 294:9
315:11
5,000,000136:10,12
5.8 289:20
5.8% 26:6
50 4:8 19:10 55:20144:2 175:21239:18
50% 239:21,22
50,000 174:4
501(c)3 301:3
501.C3 204:5
501-C4 287:7
55 19:3
5630 15:5
57 41:22
66 4:3,4
62 4:9
62.5% 264:20
697 54:10
6c 212:21
6x 212:22
770,000 174:4
75% 175:7
79% 251:1
88,000 206:5
8,788 54:8
80 38:19 144:6239:18 243:20244:2 248:14
80,000 32:20 33:1157:6
80,456 22:1
800 19:7
800-222-1222 19:9
87 4:10
99:00 1:11
90 55:20
90% 174:4 219:18229:21239:3,10,20
90's 160:22
92% 23:4
92,000 301:12
96 176:1
97% 27:1 229:18
98 71:16
98% 25:7 27:2
9c 212:21
Aa.m 1:11 106:1
AAHP 115:8122:20219:14,15 220:6221:7,9 222:13224:8 225:17226:7 227:16,22228:2,14
229:9,11,19233:8,13 234:20235:3,14 236:19240:3,11 301:8
AAHP's 219:22220:3 224:13237:9
AANBP 113:14
AANP 108:5113:7 114:7115:8 122:7,20
AAPC 25:16 32:5
AAPCC 18:1919:19,22 23:14
AAPCC.org 20:1827:19
abandon 95:16
ABC's 128:20
ability 142:13250:3 255:3
able 7:3 13:2015:19 74:1587:12 94:17 95:7121:8,13,14,17,18 135:2 154:3199:20 201:2207:16 210:16236:16 253:8,10258:11270:12,21
abnormalities174:18
abreast 110:8
absolutely 25:3171:6 202:18263:9
absorb 246:8
absorption 39:13
abundance 236:15
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abuse 24:6,14,16
abuses 258:13
academia 301:16
academic 123:19
Academy 4:1087:16,21 89:493:18
accept 109:1
acceptable 193:18278:2 279:14,22
accepted 52:15139:20 163:8183:6 189:5217:6 312:17316:12
access 7:3 20:1831:1 122:1142:6,7 156:2164:8,11,13,19180:6 192:2195:14 228:9235:19 254:22268:1 287:12290:7,12,15292:18 295:7304:13 307:4313:18
accessibility206:22
accessible 254:12261:22 267:19314:4
accidental 23:2024:3 253:3
accidentally 24:2
accordance 8:312:3 238:11291:16
according 105:18125:10 135:16
137:7,22 213:1289:14 301:14312:2,13,16314:1 315:15
Accordingly 57:1
account 22:9 23:7246:6 269:19283:2
accounted 289:12
accredited 174:2
accrediting 109:8
accuracy 29:1630:8,13 114:10
accurate 56:1191:2 114:1 115:9127:19,20 246:7252:3 312:6313:5,13 314:10
acetaminophen31:3
aceticum 39:1
achieve 89:19
acknowledge164:3
acknowledged194:12
acknowledgement169:17
acknowledges89:18
across 95:13108:20 158:14271:4 301:7302:13 306:19
act 7:11,16 42:743:12 57:8,1162:2 157:14158:22 235:12253:21 255:3
290:18
acted 227:17
acting 16:17153:20
action 116:8119:17 170:13177:22 196:4225:11227:19,22233:14319:11,16
actions 51:12225:1
activation 275:18
active 38:16 41:1443:20 44:3 47:948:21 49:4 56:1058:11 59:1292:15,21 100:18113:20 114:6180:18 194:20200:5 212:19242:10,11,16243:12 244:17246:8 250:2256:11
actively 245:10
actives 103:8
activities 181:4225:19
activity 180:18181:6
actual 30:12 31:2251:12 59:4101:15 213:12217:19
actually 13:214:13 42:12 46:662:10 68:2269:4,5,11 70:14
72:7,14 74:1276:9 77:7 78:679:10 80:17,2281:8 82:19 87:4100:16,17101:15 102:14106:9,15 130:7144:9 145:3148:3 150:22152:9 153:12180:9 188:22216:19 244:11245:20 258:6278:19
acupuncturists287:18
acute 91:1798:13,14 206:3265:8
adapted 226:17
add 13:13 14:1681:8 147:7 293:3
added 45:5 80:22239:14
addition 109:18222:4 224:7235:17 265:13279:16
additional 14:2015:13 89:14 92:493:13 113:5210:12 225:21232:5,8 253:7
Additionally205:22
address 11:1763:5 99:6 113:3160:19 173:20181:13 194:11195:2 204:17207:3 225:11229:3,4 242:20
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260:19 266:18288:22 292:12297:4,19 302:8
addressed 244:1285:20 315:5
addressing 20:10206:2 248:21282:19
adequate 93:15141:12 142:1184:17 195:22207:5 216:11225:8 236:8266:20 267:3293:9 298:15,16299:15 306:1313:17
adequately 69:5,6138:9 147:15234:13
adhere 179:16233:1
adherence231:14,16,18311:16
adjunct 173:10
administer 113:2304:6
administered 37:3
administration6:5 12:13 51:3104:10,12 105:3163:19 173:18179:1 235:8272:3,4,5,8,13,17,21,22 273:19274:3 275:3280:20 281:12312:9
administrations
104:22
Administration's1:4
adopted 235:3,14
Adriane 2:5 4:635:10,13
ads 235:15
adult 24:2 25:338:20 260:5
adults 23:11250:6,16
advance 17:1734:13 117:16225:9
advantage 92:18309:10
advent 185:1
advents 202:13
adverse 19:8 20:921:6 23:19 24:1825:4 115:16133:13 134:6174:6 186:22202:13 215:10221:17 222:6232:14 254:4273:5 278:9286:10 291:12297:11
advertised 40:10
advertising 139:7235:4,5,13
advice 218:1223:10,14314:17
advise 195:22
advised 55:14
advisor 119:10
advisory 260:1
advocacy 50:13248:20 289:2
advocate 287:11
advocates 79:7290:19
affairs 6:4 16:750:15 178:22219:5 248:9
affect 24:2225:1,2,9 27:2,333:15,16,19,20,21 178:3
affected 13:8
affects 25:21,2228:9 33:9 34:3
affiliate 50:20
affordable 113:1192:3 261:17262:3 267:19290:18
affordably 304:15
afraid 189:12
afternoon 178:19179:18,22191:7,10 197:1203:18 218:20248:8 259:8269:6 300:22311:4
afterward 169:12
against 32:1451:20 52:19 53:873:6 174:19225:1 227:18,19228:1 233:15
age 22:1423:4,10,15 30:354:9 88:2 144:6
154:16 174:17176:1 177:19
agencies 287:10313:20
agency 36:1753:19 56:2159:16 62:8162:18 171:13229:4 231:12233:14,18 292:6
Agency's 9:1553:21 228:2231:5
agenda 13:18,19247:16 288:21
agent 31:2 117:9
agents 21:22 22:1224:13,20 25:826:2 54:7,1766:12 118:14
aggregated 31:8
agnostic 197:17
ago 95:12 200:13229:16 244:12278:21 301:6
Agriculture 313:4314:9
ahead 6:10 12:1917:19 106:19144:3 300:4
AHIMA 133:18
aid 209:2 312:8
ailments 96:15114:18 254:11261:18265:12,22267:20
aisle 145:14 146:3198:10 307:21
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alerts 312:14
aligned 269:15
aligning 195:7
alike 169:20220:14
Alison 2:15 4:17
allergen 310:7
allergens 309:21310:8
allergic 303:10
allergies 194:8265:11 302:21303:9 308:18309:6 310:2
allergy 194:10,11
alleviation 310:20
alliance 31:17
Allison 203:16,19
allocated 13:18
allopathic197:4,10 198:15231:10 236:10253:15 261:13267:6 283:12284:18
allow 9:9,20 57:22101:5 106:16135:14,20136:12 143:7161:8 164:18187:15
allowed 46:1693:11 143:9149:7 161:2
allowing 40:16122:22 134:12314:20
allows 78:12,13
81:1 85:1 93:5133:7,8 195:13307:3
Aloe 93:4
alongside 37:840:15 121:5304:3
alpha 40:3
alphabet 122:21
already 75:9 85:1189:10 97:2102:13 115:5141:2 171:19172:18 207:6229:20 252:18278:22 293:3299:19
alternate 75:13164:9
alternative 36:764:8 135:19190:6 245:11260:15 263:1266:6,11 271:14276:16 282:15288:3
Alyssa 5:3 286:21287:3
ALYSSE 3:2
am 18:4 63:12,2187:20 88:8,12107:13,17125:15 128:17132:2 134:3153:19 154:1155:1,3 174:3,13175:11,14178:20180:10,15,17181:6,14 183:10185:21
203:19,22211:6,7 218:21219:4,12 234:2,4260:16 269:8287:3 298:10301:8,9,13307:1,6 308:14311:5,9 319:9,12320:4
AMA 42:16150:16,18
AMA's 43:2
Amazon.com262:6
amenable 193:14226:6 227:14231:8 243:4
amended 242:19
America 143:21
American 4:21 5:619:5 21:17 22:1023:2 27:17 42:1651:15 54:559:6,15 88:994:22 95:1107:4,12111:9,10 112:12113:12 149:4153:13 176:16180:11,13218:18,22224:14 228:19234:3 252:15260:4 266:13296:9 311:3,9314:4
Americans 10:20249:12 288:1
America's 19:3
Amerine 2:8 4:1087:15,17,19
97:15 99:19101:11,17102:21 103:14104:15 107:18
Amering 116:1
Amherst 107:19108:1 116:11117:22
among 26:1 89:22198:12 216:1,3217:4 220:1249:13 250:15266:3 289:18
amongst 95:20182:4 185:14,22
amount 100:21105:7 187:7202:4 246:11281:3 306:20
amounts 75:1103:16 159:6172:7
ample 140:19
amplify 220:14
Amy 2:9 106:21107:3,11
amyloidosis211:14
analgesic 280:20
Anals 65:18
analyses 72:1,5
analysis 41:2065:11,13 70:1371:6 201:16253:9
analytically 201:5
analyze 83:13
anatomical 174:17
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anatomy 109:13
and/or 81:8
anecdotal316:11,13,16
anesthesia 274:13
anesthetic 274:19275:3
animal 66:9 98:16
animals 118:13279:8
ANNMARIE320:4,13
annotate 15:7
announce 57:2
announcement222:12 248:22
announcements58:16,21 223:2
annoying 129:6
annual 22:6 23:1227:16 110:4203:5 294:11
annually 222:11
Annuals 76:16
answer 28:1529:11 68:1274:14,16,2275:22 81:1583:3,12 84:19105:13 130:19131:15 132:16146:17 154:3177:9 181:19222:22237:12,16258:11 289:8292:9 293:12296:15
answered 177:10
answering 132:17298:11
answers 31:1881:16 145:9146:9,13 154:5279:21
antacids 32:13,14199:10
antagonists199:11,21
ANTHONY 3:5
anti 211:17 213:16
anti-allergy 40:10
antibiotics 260:18263:8
anticipate 239:17247:6
anticipated242:17
anticipation 12:18275:2
anti-convulsent56:3
antidepressants78:3
anti-inflammatory40:8
anxiety 265:11
anybody 63:22107:9 119:1
anymore 152:1
anyone 87:10141:4 252:12
anything 14:1523:16 33:4 54:1565:5 77:6 128:10
131:4 145:2147:8 148:21188:8 256:22258:12 309:13
anyway 31:20
apart 89:20188:13,16
apologies 154:10
apologize 33:1334:13,16 168:17203:10 269:4
apparently 47:18120:21 265:6
appealing 122:11
appear 314:12
APPEARANCES3:1
appeared 46:21
appears 235:15319:4
applaud 51:2
applicability230:1
application 44:1961:19 62:14116:22 171:15172:2 226:16,18
applications117:18
applied 67:11 69:470:9
apply 12:7 70:685:4 140:15156:16 302:18
applying 72:3102:9
appreciate 132:18153:2 170:18
206:15208:12,17 211:1253:18 266:20267:6
appreciative317:20
approach 56:1069:4 73:18 75:1879:18 103:10109:19 122:9184:14 188:18189:4 228:3,4,8229:11 263:14305:1
approached179:10
approaches 63:1769:16 70:17 77:179:15 85:3 190:6245:11
appropriate 7:870:21 99:7108:12 114:1126:12 133:6135:3 138:4140:11,20 141:2146:21 150:8159:6 160:17161:9 163:4192:5,15,18,20194:5,12195:5,18 198:14216:21224:17,22 227:7228:4 229:7231:1 243:7276:5 298:9
appropriately10:6 138:12140:17 196:1227:10 233:5
appropriateness
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70:18 137:13192:12
approval 8:29:6,14 45:8157:22 227:4243:10
approved 40:544:20 55:22 78:6157:5 158:2171:20 174:19
approximately26:6 105:22178:15 181:16229:21 230:11247:20 248:1318:2
April 1:10 55:15
archived 252:11
area 46:5 61:678:11 80:15 83:1126:18 135:10155:8 164:6165:5,18226:8,12 274:20281:14 301:17
areas 10:963:10,11 65:868:9 69:12,2270:10 71:21 72:573:16 74:575:3,5,14,18,2276:12 77:2078:7,14,18,2279:9,13 80:18,2082:12 83:1786:12 92:2,3113:4,15 135:5225:20
arena 107:21
aren't 20:13149:19
argue 56:12 84:11
argument 79:1,2146:16,19
arguments 225:9
Arizona 4:11131:20 132:2,7133:18 134:17150:10
arm 80:22 159:8
Army 64:4
Arnett 2:14 4:16190:22 191:3,7,8196:16 197:11199:5 201:11202:15 203:9
Arnica 100:15
arose 189:14
array 185:2198:11
arrive 12:20105:19 186:11
arrived 170:19
arrives 188:14
art 111:6
arthritis 76:1497:11 98:7,21267:13
article 74:11 76:17116:11 260:9
articles 7:12 220:9265:20 294:12
ascertain 230:21
aside 51:21 110:21155:2
aspect 28:12246:14 306:6
aspects 15:20
63:16 286:7
aspirin 31:3
assay 201:2,4
assayed 202:4
assays 238:19
assess 10:12 128:5193:10 276:2292:6
assessed 275:5
assessing 52:6
assessment 41:2177:7 79:12 83:1117:19,20 129:1172:3
assessments 82:21128:12
assign 202:21
assist 205:19
Assistant 16:5
Assoc 4:21,22
Associate 16:1735:13 180:15
associated 20:827:13 46:15,1750:19
association 4:1218:14 19:5 27:1754:5 88:9 94:22107:4,12111:10,11112:12 113:12131:21 133:19219:1,15 228:19234:3 235:8237:10248:6,10,11252:16 296:9
associations
160:15 164:22
Assosication218:18
assume 37:1240:20 147:16214:1 257:10
assuming 85:15
assurance 288:14
assure 254:6288:2,15
assured 288:3
assures 291:22294:4,5
assuring 192:2295:10 313:18
asthma 40:11 53:9115:4 227:21
astute 154:11
Attachment 260:2
attempt 65:1592:8 297:4
attempted 76:16
attempting 74:13
attempts 71:19
attend 109:4
attended 177:20
attention 18:1828:1 68:15 78:1296:6,7 208:14215:17 275:13280:10 295:12
attenuation230:10 231:21
attest 168:11
attestation 168:10
attitudes 10:1090:15 112:1
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181:22 204:21206:8 223:5,19250:1,11 259:20260:20 289:6,9290:5 291:14302:9
attorney 319:13
attribute 130:7
attributed 54:8
attributes 290:2
attuned 305:10
audible 177:7268:20 300:15
audience 18:2
audiences 220:10
audits 150:2
August 235:1
Aurvedic 163:1
Australia 56:282:17
Australian 52:354:20 75:8,1676:10
Australia's 41:22
authored 36:3
authorities 224:9226:15 227:2
authority 7:14,1811:1 62:3,7138:9,16 221:1224:21
authorization226:15,16,20227:1 232:14
authorized156:14,18,20157:7
autistic 128:15
auto 19:18
autoimmune98:21
auto-immune 40:9
automatically19:18
autumnale 211:17212:15,19213:6,14214:5,18 215:19216:13 218:4
availability249:10 290:5
available 8:2110:21 19:1220:19 27:20 29:956:13 66:1596:17 122:17134:22 135:15139:15 141:16142:3 152:7196:18 199:13208:3 212:17231:11 236:15239:8 249:21252:10 262:5304:7 307:12,20308:10 309:11
Avenue 1:14
average 26:2139:7 134:6 199:1231:2 278:12
averages 279:7
Avogadro's 49:13
avoid 184:3,4215:5
avoided 115:1217:1
avoiding 216:6
award 259:11
awarded 89:14110:1 118:4
aware 52:18146:11 182:6,7215:9 221:8222:2 232:19258:14,22260:17 273:13281:15 283:17286:1 304:19
awareness 139:13
away 87:5 145:3
awesome 125:13
BBabes 260:3
background114:13 191:12287:6 288:6302:5
backlogs 227:3
bad 95:15 145:5149:7 303:13
balance 164:16165:15 180:4230:20 257:15
Baltimore 5:2269:5
bane 315:2
banner 41:11
Barbara 2:20 4:22248:4,8 255:7,10
barriers 151:2
base 205:13
based 6:21 30:235:18 46:3
84:7,8 85:1091:4 123:18,20134:16 156:11158:16,17162:11 164:4,5171:8 198:12199:14 213:15222:15 223:10226:19,20235:10239:12,13247:2,4 254:16275:8 276:11278:3 280:5292:1 293:1308:16 313:9
basic 63:18 91:19109:12 206:2
basically 11:222:8,15 25:1316:22
basis 21:12 22:2,752:16 58:21 91:2165:8 203:5207:12 244:2
Bastyr 173:11174:1,2,3,7175:9,13,15176:18
batch 202:5
batches 247:5
bear 54:3 84:12157:1 161:20173:6 234:21
bears 156:21
became 65:3132:20 264:2302:2
become 41:17152:18 159:10183:1 260:17
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261:5,7,11264:9,16 266:16302:15 314:21
beds 138:2
bedside 280:22
beg 34:19
begin 13:10 155:9260:22
beginning 68:13284:16
behalf 12:1350:16,18 255:6317:10
behavioral 78:8
behind 178:8247:16
belief 43:1
believe 54:1 56:16113:7,10 124:19144:19 161:14172:10 177:20200:7 213:5228:2,8 253:16256:6 264:9306:11 313:1
believed 38:1214:10
believes 92:993:12 113:7122:8 195:22
believing 53:16
Belle 175:20
belong 19:4190:16
beneficial 218:1
benefit 92:4 113:5180:7 225:21240:4 270:21271:1 275:2
278:6,10,15279:20 295:21296:22 307:22
benefited 132:21
benefits 10:1241:19 151:21182:8 183:22184:12 185:18186:13 224:6,12292:6
benign 276:14283:22
Bent 16:4,5 33:748:20 49:3101:4,14 102:14152:5 186:10238:22 255:14256:1 285:19295:18 296:4
best 66:1 75:16,1976:18 78:15115:9 142:10191:18 242:18260:2 290:2291:16 305:8308:16 313:1
better 9:22 29:1134:18 78:7,2195:5 101:2 116:4128:19 129:5,7,8131:6 146:7176:20 187:19235:1 242:6250:13 252:14258:5 264:2,10283:22 292:6295:1
beyond 38:9 71:2189:10 147:1258:10
bias 69:8 70:2,372:17 74:5,18
85:2,4,10 270:15
biased 71:14185:20
Bible 270:5
bibles 140:1
biggest 186:19262:11 305:14
billion 222:11,14289:13
billions 53:15
bi-monthly 206:1
binding 54:16
binomial 44:7
biochemistry109:13
biodentical 124:15
bioethics 269:10
biologic 117:13
biological 90:1691:8 112:2117:14 182:1289:7 292:7
biology 52:14118:17
biomedical 67:20117:18
Biostatistics 16:10
birth 175:3 259:22
births 175:11
bit 33:19 47:2178:10 81:7104:19 118:2143:8 155:3,6,9157:11 159:13185:20 186:14196:14 202:11241:1 245:16256:5 269:8,21
271:1 278:14284:17 295:19303:17 315:6317:4
bitty 129:21
Bldg 1:15
blind 85:18147:20,21148:11,13149:8,9 275:4
blue 272:20273:10
board 87:20 88:789:14 107:19110:19 111:13132:5 134:3,14180:10,11,13228:18 234:3
boards 260:1293:22
boast 58:6 175:15
bodies 52:15 109:8228:7 261:8,9293:19 305:11
Boggs 17:13
book 71:12 95:2196:9 144:21263:22 264:5
books 36:3 96:9280:13
boon 309:12
borders 154:19
born 174:15175:4,5
botanical 109:22131:1 238:4
botanicals 125:4238:7
bothers 129:5
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284:5
bottle 30:11315:14
bought 245:2
boundaries 101:2
boundary 232:19
box 8:18
boys 301:13
Brad 17:4 104:6
brag 171:12
brain 66:11121:22 281:14
branded 227:12248:16
bravery 177:4
bread 131:8
breadth 236:3293:14
break 15:16 87:17105:18 106:21107:18 178:7
breaks 22:6
breast 55:5 120:5121:20
bridge 63:1
brief 22:18 149:13186:5 302:4
briefly 20:21 51:8103:2 161:13,14164:1 167:8168:19 246:12
bring 119:15154:5 156:15162:12 167:16192:6 216:4267:17
bringing 107:20
121:7
brings 248:18
Britain 136:18
British 137:7
broad 69:15117:14 220:22224:21 249:6259:19 311:15315:7
broader 304:18
broadly 314:4
broken 23:12272:16
bronchitis 40:11
brought 9:5 84:1285:8 215:17
Bruce 2:10 4:11131:19 132:1
bruise 98:16
bruises 303:9
bruising 100:15
brunt 54:3
brush 69:15
budget 304:12
build 82:10 115:6
building 15:20
built 125:19314:17
bullet 149:13
bump 120:3
bumps 303:9
burdensome227:5
buried 25:1595:20 144:8
bury 95:17
bus 144:1,3
business 141:10147:10 150:3
businesses 141:10151:19
busy 91:13 158:19179:5 191:16
butter 131:8
button 154:10191:5
buy 96:15 165:1178:13 223:6,9244:6,16 250:21261:2
buying 56:22214:2 244:14
buys 245:1
Ccabinet 173:15
cafeteria 15:21
Calabrese 116:10119:10,19
calculations 80:16
California 180:10
CAM 137:15289:16,18,22
Campus 1:13
Canada 4:13153:15,16,17,22154:14 155:4156:5,8,16157:5,7,12,20158:12160:10,11161:16 164:1,3165:15 169:3,17
Canada's 155:10
Canadian 164:7
Canadians 155:11156:1 157:4
cancel 106:14
cancels 106:10
cancer 55:8,11,1266:12 120:6121:6,8
capacity 165:10218:22 234:2
Capital 1:19
capture 82:11,1383:13
carcinomas 55:5
cardinal 234:16
care 65:2 90:1591:16 96:8 98:15108:2 110:13,16114:9,16 115:22120:10121:6,8,14133:15 161:9169:18 180:4182:13,14,19183:5 189:13,17197:14 205:4,6206:3 249:7250:8 259:22264:12 267:9,15268:14 279:19287:22290:10,18,20293:1 294:5,12295:10 304:14
career 119:13125:20176:10,13197:12
careful 282:19308:18 309:22
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caring 115:14
carried 118:9
carry 175:11
carton 197:21
cartoon 68:5272:5
Cascade 95:14
case 15:5 19:1539:6 72:3 97:2299:6 106:22118:8 120:20156:5 160:4161:20 171:11172:8,10 183:2198:4 203:4208:8 214:12216:12 253:2,7,9272:14 273:8274:11 275:4276:17 278:5281:10 285:6,12317:6
cases 54:7,8,1055:3 70:1 88:18155:21215:17,19216:16 217:15218:6 303:17
cast 156:12
catch 83:11
categories 32:4118:12 190:12226:6 227:13234:16243:4,19,20244:1,3 284:3
categorization255:21
categorizes 203:2
category 68:14
92:21,22 158:18162:1 173:1199:10 249:18300:13
catorelcok(ph273:22
cause 39:13 48:1454:2 61:4 102:12103:16 177:21
caused 51:1153:21 54:12,13172:3 174:14,18
causing 87:6
caution 15:1017:11
cavity 105:11
CDER 4:4
cease 14:5
cell 66:9,11 117:9199:22
cells 118:13
center 4:5,7,8,186:6,12 17:6,2118:6,7,13,1619:3,10 20:2221:2 26:10,13,1731:19,22 33:535:11,16 36:850:9,12,22 52:2059:20 60:1364:15 85:19108:1 181:14185:15203:17,20 224:7253:6 292:19294:7 299:2
centered 234:8287:14
centers 19:4,621:17 22:11
23:3,8 27:14,1828:21 30:931:14,15 54:5221:21 236:2252:16
central 127:20290:16
centuries 52:13
CEO 62:18 191:8
certain 8:3 32:2175:11 77:3122:18 193:22196:21 211:13239:13 249:19258:10 309:14
certainly 18:247:1 49:19216:12 240:4259:1 262:11297:17 310:10317:15
certificate 201:15319:1 320:1
certification293:22
certified 87:21107:17 180:10287:17,18290:15 293:14
certify 319:3320:4
certifying 293:18
CFI 50:19
CFR 233:7
CFR's 238:11
CGMP 112:14
CGMP's 254:4
CGNP 201:13,14
chaff 70:11
chain 101:15
chair 70:14 180:17
Chairman 234:5
challenge 180:3
challenges 155:7165:4
chance 14:18 80:8154:8 175:7218:7
chances 49:12
change 31:9,1080:5 114:2115:6,17 116:2138:8 141:9146:12 258:12273:15 282:13
changed 169:4,7241:22 272:12
changes 142:18241:8,9
changing 73:10230:18
channel 292:19293:2
channels 299:16
chapter 36:4
chapters 301:6
characterized116:17
charged 53:2064:10 176:5
charlatans 42:22
Charles 17:8
charting 145:19
check 201:3
chemical 44:4
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118:11
chemistry 52:14
chemo 121:20
chemotherapy120:11
Chicago 71:11
child 23:21 25:230:22 31:4128:15,17259:22 268:17304:21 305:1307:16
children 23:3 27:130:2,5 31:154:2,9 260:5,13261:17 262:9,22263:7,8 264:3,10304:8,14305:5,10 308:21310:2,4
children's261:9,18 263:21265:7 304:20
child's 128:18
Chinese 163:1
Chiropractic79:17
chiropractors287:17
choice 56:15,16,17115:21 145:12199:14 206:15208:18 209:2,3228:10257:12,21290:13,16 295:7299:6 307:13
choices 10:3 56:18176:10198:11,16 223:9
236:18 251:3252:1 254:14288:4 294:19295:8299:17,21,22
choose 54:21135:2 198:11210:1 262:2295:6 297:22308:13
chooses 214:17
choosing 210:6
chose 95:17132:16 133:8
chosen 176:13
CHPA 248:11250:12252:2,8,21253:13
Chris 179:11
chronic 40:8114:18
circle 122:7
circumstance189:17 217:3
circumstances189:9
citation 20:1
cite 296:21
citing 225:4
claim 53:9 93:6163:16 166:11232:16
claimed 58:1159:12 76:12
claiming 64:22166:19
claims 36:16
41:5,7 139:8161:3,8,19 162:1163:18166:7,8,16
clarification 92:1293:13 113:16115:18 146:16242:5
clarifications122:19
clarified 113:11
clarify 14:1432:18 95:7102:14 115:8124:6 146:7189:20 197:8198:19 255:14258:5 298:12
clarifying 29:14101:1 123:18166:5
clarity 85:7 92:4113:5 225:22226:4 243:2257:13 293:5
class 11:1132:14,15 42:19118:18
classes 109:15268:16
classical 36:2148:5
classification254:17
classifications32:17
classifies 203:2
classroom 110:2
clean 150:6
clear 7:13 10:2234:4 41:17 92:17107:8 113:22134:21140:14,21167:20 168:3181:6 190:7,8,18197:9 198:3214:11 242:21280:1 284:4285:3 308:3
clearer 129:7
clearly 23:4 35:2,451:7 56:7 93:1203:13 207:18212:5 213:10,20232:18 233:10234:19 237:7295:5 297:21298:2 305:4315:8
client 84:19
clients 294:3
clinic 55:14 64:19108:10 270:22
clinical 18:565:11,17 71:1795:2 110:2,19123:21 152:11162:18 163:13177:16 181:2,10182:10,18,20184:8,20 185:19186:3 193:8196:22 232:11274:7 276:6277:17 278:4287:22 291:13292:22 313:10
clinically 180:17183:21 217:5269:22 270:11
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clinician 39:8182:3 183:20275:4 279:15
clinicians 111:11185:14
clock 105:18123:15 165:22178:10
close 72:14,15103:3 141:10197:3 231:14
closed 280:19,22
closely 70:13222:18
closer 122:19
closest 143:1
closing 10:1995:11 317:2
closure 31:5
closures 30:22
clothing 108:2
CMC 167:12168:7
Cochrane 71:8
code 28:22 29:1,332:7 42:22311:17
cofounded 110:22
co-intervention270:16
colchicine211:16,22 212:6213:8,9,11,12214:6,13,18215:14,21 218:5
colchicum 211:17212:14,18
213:6,14214:5,18 215:19216:13 218:4
cold 38:22 91:1798:7,13,14191:18,20194:9,10198:4,6,10262:22
Cold-EEZE 38:17
colds 194:7 206:4265:8 266:2303:8
co-leader 88:12
colitis 55:17
collaborate176:20
collaboration 71:8113:12
Collaboration.gov/hprApril2015317:8
collaboratively108:20 220:18
collated 127:11
collation 97:5
colleagues 12:2165:9,10 87:1108:18 159:2183:14 184:7201:21 203:10282:11
collect 97:17 102:1103:19 104:2
collected 98:3101:22
collecting 88:15103:6
collection 102:4
collective 88:1397:17
College 149:5179:20
colleges 138:1174:11
collegial 317:22
Colloca 2:22 5:2269:3,4,6 281:2282:4 284:11,22286:5
colon 55:18,21
Colorado 88:6
coloring 303:4
COLUMBIA319:20
combat 42:20
combination92:15 100:16101:12 113:19242:9,11 271:14274:3
combinations225:6 242:15
comes 14:8 19:1521:1 30:9 56:2298:8 100:11114:9 163:19164:5 172:17238:6 270:5283:19 296:8310:11
comfortable184:13 250:6274:20 299:1
coming 6:16 12:2120:21 101:9112:4 126:2130:15 144:19157:10 198:8
209:14 248:3317:12
comment 48:1,2066:18 94:1297:9,14 124:11169:6,9 201:7208:18 232:4249:3 258:14283:5,6,7284:21,22 300:2
commented 61:9
comments 7:714:19,2215:2,8,1360:8,22 61:8188:12 195:16250:17 297:5317:2
commercial 35:21124:3 222:15
commercially124:2
commission 36:1160:14 138:13219:3 224:14
Commissioner16:6 17:3 173:16
commit 240:3
commitment195:19 220:3237:9 248:19
committed 88:390:8 223:7
Committee 50:20
commodities155:13 156:2158:15,21
common 44:8 98:7191:17,20 194:9198:5 227:3
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303:8,19
commonly 315:7
communicating128:19
communication285:20 286:2
communications203:22 207:14221:11
community 89:792:7 109:2150:14 151:20176:17 182:22183:6 189:6,11195:21 205:11207:7 216:5259:16 264:16265:17 268:3293:7
companies 39:2253:12 138:11144:16 159:10192:6 229:6,18230:3,7,16248:17 288:9
company 1:1913:7 63:21166:10 191:13192:14,18 234:5244:12 246:16
company's 195:18
comparative67:16 78:1081:6,10 85:22
compare 24:932:19 67:15126:14 236:9276:15
compared24:13,20 32:1378:13 80:10 86:2
100:22276:18,21 279:2285:7 289:22
comparing 22:2025:18
comparison 231:9
compassionate176:17
compatible 276:20
compendia 254:6
compendium101:7 187:14
compendiums142:9
compensated18:15
compilation316:10
compile 97:20
compiled 88:20
compiling 316:13
complacency214:7
complaints134:5,6,9 312:18
complementary135:22 190:6287:9 288:2
complete 52:13202:17 320:9
completed 137:11232:4
completely 38:2147:21 198:14245:22
completion 89:13
complex 297:3
compliance 7:228:9 9:17 11:216:6 17:5 113:17116:4158:7,9,10,13159:8 168:13192:22 201:14220:1,2,5,7,10,15,16 224:19225:16 226:1227:10 231:6,20233:6 234:11237:2 252:10253:16288:16,17 291:3292:1
complications278:7
compliment 32:19267:9
complimentary36:3,5,8 52:20133:3 135:18266:7 292:17
comply 11:8 37:17196:4 306:16
component85:14,20271:10,20274:4,5 275:2282:17,18284:12 285:7,14
components72:2,4 85:4188:22
composition 29:10
compounded 37:2124:5
compounding110:12124:7,12,14
149:17,20
compounds 41:1447:18
comprehensive79:11 80:1108:10 110:13137:10 187:14225:11 264:4278:17
comprised 95:6205:13
computer 273:14
conceived 118:8
concentration39:3,9117:5,11,17170:14,15,20171:1,2
concept 99:11
concepts 7:6263:15
concern 30:3 37:448:11 53:19172:4 302:8312:5
concerned 36:1337:5 105:8 146:8247:10 261:8
concerning 39:22104:12
concerns 43:6160:18,20,21173:5,21 192:11216:7 222:3261:11 306:17
concession 42:8
conclude 14:3,727:22 52:8236:19 317:1
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concluded 42:2297:20 318:4
concludes 186:4
concluding 247:17285:19
conclusion 12:1120:2 122:6142:12 236:22267:14 282:3
concurrently218:16
condition 45:1153:2,10 76:1384:8 96:598:12,14 161:2166:15193:14,17197:16 200:10213:19 245:8,12258:10 279:5283:1 305:8
conditions 8:337:7 40:5 42:252:9 53:7 65:1776:6 77:383:16,18 84:1491:17 92:1,1095:19 113:8114:15 137:16140:15,18163:18 191:17192:8 194:1,3,12195:3,15 196:18216:22 220:17227:20 231:8236:11 242:20249:14 250:22254:13,15 265:8271:4 294:20303:8,19 304:16
conducted 52:5173:13 250:12
conducting 118:19
conferences294:11
confidence 128:1157:4 264:18
confident 200:11250:3
confirm 193:2,5194:19200:15,20
confirming 192:1
confirms 212:3
conflict 107:15211:5 280:4
conflicts 35:2163:19
conforming213:16,22
confusing 46:7114:22
confusion 7:17100:7 190:11,14216:9 314:15
congestion 266:2
Congress 111:12235:11
Congressional287:8
conjunction 80:490:22 231:19303:21
connected 19:6
Connecticut 132:6
connecting 301:4
consensus 287:8
consent 294:2
consequence
216:6
consequences214:8
conservative133:22
consider 46:1452:2 126:21149:6 199:9244:9 269:22271:6 288:17293:5
considerable223:8 244:7,9
consideration90:22 96:21185:12
considered 38:739:20 42:743:5,7 47:16,1980:4 82:19 93:10136:17 139:17150:3 155:20,21313:20
considering 232:9
consisted 230:20
consistency 44:20112:11
consistent 112:21122:11 192:21194:21 239:6
consists 94:20277:11
Consortium 5:4286:22 287:5
constant 289:1
Constantine 95:22
constantly 244:18
constituents 204:4207:15
constraints 230:19
consult 306:20315:17
consultant 36:11288:8
consultations290:11
consulted 175:9
consulting 18:5228:22
consumer 4:228:17 9:3 10:1018:13 39:4,741:12 53:5 58:1560:3 90:14 94:296:14 100:6,8111:22 140:15155:13 167:8181:21 188:8191:13 198:1,8199:1,6 200:8202:15204:2,10,15,20205:9 206:8207:4,22 216:9223:4,13 232:12233:22235:5,19,22237:7 245:13248:5,10 249:1250:10,12,13252:4 254:8,22257:10 259:20260:20 289:5,8290:14,20292:22 294:6,21298:18 299:1,3302:9 306:14311:20313:17,18
consumers37:11,14 40:20
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46:7 50:6 53:1454:1 58:17 91:1893:14 94:1595:10 96:10100:22 115:1139:12141:11,18,19142:15 145:10156:18 180:5184:16 191:16192:9 195:13,20197:14199:12,18204:12,16205:4,14,19206:1,8,10207:7,11,12,16,19 208:1 209:14214:8,22 215:1,6223:6,9 224:3228:10 234:14235:2236:4,9,14,16244:6,13249:6,8,22250:19251:1,18,20,21252:2,6254:10,14,18256:7,15,19258:6 261:11,13262:1 263:11,18267:5,14 293:9294:18,22295:3,4 297:22299:6,16,20306:1
Consumer's264:14
consumption159:6,7 171:10
contact 280:21281:3
contacting 309:19
contain 38:1539:18 41:1443:21 45:2247:3,4 54:15309:21
contained 171:16
container 23:21
containing 40:146:22 92:14113:19 159:4171:19 309:8
contains 38:1739:1 40:3
content 201:5
context 77:14117:15 155:7164:1 180:22183:18 184:1,20281:7
continue 45:253:15 58:20 64:696:17 165:16259:17 299:21
continued 3:136:18 65:20192:2 264:12268:1
continues 118:10237:3
continuing 90:592:6 110:5165:11
continuous 111:4
contra 249:18
contract 236:13
contraindicated304:9
contrary 53:12
contrast 9:11
contributed 43:11176:4
control 19:5 27:1854:5 71:18 236:2238:7 249:10252:16 285:11288:15
controlled 39:1869:18 77:2 85:18168:15 246:14
controls 201:9254:4
controversial70:10
controversy63:9,11 79:2
Convention 95:1291:14
conventional 31:237:8,13 40:15,1741:2,8 44:1246:15 65:2 80:5120:10 121:6,13149:16 184:5185:9 187:10271:13 276:16277:1 279:3,17282:15 287:20298:19 303:3,22304:2 305:17306:22 308:3
conversation160:14 170:9184:10 199:19
conversations154:21 265:22
Conversely270:16 272:8273:12
coordinated288:14
cop 14:9
COPD 40:11
Copeland 42:8
copper 39:12
copy 13:19
cordial 106:17
core 140:12
corn 302:22
corner 301:19
corporate 232:16
Corporation70:14 79:17
correct 140:8146:17 209:11312:22 320:9
corrected 312:20
correctly 62:1,1989:2 98:5 101:18191:1 209:6269:4 296:18298:7 299:13
Cosmetic 7:1042:7 57:8 62:2
cosmetics 155:21
cost 67:15 81:13112:9 115:2122:10 137:18206:13 228:9249:11 254:11262:3 276:22278:6,11 285:10
cost/provide 280:2
costly 227:5
costs 81:12 276:22
cough 262:22
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264:6 266:1
cough/cold 198:10
coughs 206:4264:8 265:8
Council 42:1 52:4
counsel 16:12 17:5319:10,13
counter 9:3 38:1240:1846:16,18,2161:19 91:1696:18 98:11,1899:14,16 101:12114:21 115:20120:16169:14,21170:3,7,8 174:8191:14 206:16207:1 212:11,14213:7 217:1241:20 248:12260:12 261:20262:21 303:6307:20
counterintuitive170:17
counterparts154:17 155:2165:11,17 197:4
countries 135:8,14136:5,9,11,16,19143:16,17144:2,4226:11,14232:15 264:17
country 84:495:13 108:7109:3 111:19122:4 132:4135:12,20,22136:7 144:13,14146:9 302:13
306:4 313:11
couple 12:2225:10 75:4,9106:20 120:3200:13 302:6315:19
course 10:5 52:11121:2 138:14148:20 155:11163:14 281:4,5286:15 296:9
courses 137:6142:8
Court 320:5,7
cover 146:1157:17,19259:17 290:20293:1
covered 252:19
covering 259:12
CPG 92:3113:4,8,17114:13 138:4,10192:9,13195:12,20,22221:4 224:17,22225:8,13,21228:3 233:14242:17 245:18254:1 255:3258:14,16
Craven 55:4
create 105:12124:21 152:17286:15 292:19310:19
created 243:19287:7
creating 311:18
credentialed
290:7
credible 309:15
credo 177:1
crescendoed 31:12
crises 59:1
criteria 52:7 77:482:16 84:21212:3 313:5314:10
critical 97:6116:13,14132:22
cross 98:19 154:19232:2
crucial 142:13
crude 103:22
CTD 226:19
cultural 164:11
cure 45:10
cured 88:18
cures 310:17
curious 65:3 97:4128:2 130:3170:12 188:13246:12 299:16
current 7:20 36:1367:12 69:1676:14,21 79:1392:2,3 110:21113:4 115:17122:8 138:20140:10,22141:16142:14,18146:14,20 155:6192:5,12195:12,22220:16224:16,19
225:16,21 226:1228:2,8 234:10249:4 254:21278:17 280:6291:22 305:21306:16 313:16
currently 9:1844:5 58:5 62:264:15 66:5 88:7109:6 138:8139:11 140:19146:10 157:6173:11 198:20229:6 298:5302:18 306:12312:18
Customer 191:21
customers 151:19
customizing 305:1
cuts 194:8
CVS 99:16 240:14
DD.C 153:10 301:17
Daddy 268:16
Daddy's 268:13
dads 301:2,10
dad's300:18,19,20
daily 94:1 95:4206:10 207:12223:21 276:6
dairy 302:22
damage 174:14
danger 56:9134:11 214:4
dangerous 57:2259:5 91:16
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dangers 40:11
Daniel 153:12
dare 177:2 185:7
data 10:11 18:1119:17,19,2220:1,3,9,16,1921:11,1222:3,20,2123:11,13 25:1427:19 28:7,1929:9 30:8 31:732:5,10,11 33:560:1,6 79:784:11 85:1,7,986:1897:5,6,17,18101:5,22102:5,19 103:6139:20 150:5162:19 177:16195:8 196:14224:4,7 241:15244:8,10 249:1252:14,19,21253:8,9 292:4,18296:21 316:7,17
database 19:2025:16 28:21236:7 252:17
date 45:12 88:2289:1 161:12
daughter 174:13262:14
daughter-in-law262:14
Dave 17:12
day 1:9 6:1717:11,1219:12,1338:19,20 154:16174:21 175:4177:19 190:17
265:12 317:1,19
days 10:17 176:8255:8 278:13
deadline 253:11
deadly 59:5
deal 7:17 10:16152:2 303:20308:7
deals 257:9
deaths 25:11
debate 222:10,17
decade 181:16204:1
decades 51:5,1871:4 75:5 112:16115:13 122:13174:5 263:10269:11 293:16
deceptive 214:19
decide 104:9237:15 241:3
decided 43:3117:22 170:21283:17
decides 45:2
decision 41:13145:11 161:10162:17 164:8210:1,4,16216:11 250:21286:18
decisions 93:1696:11 141:13142:7 184:18206:20207:6,8,17 234:9236:17 293:10294:4 295:1299:6 306:1
deck 236:7
decrease 31:16
dedicate 221:10
dedicated176:9,14,18204:6
dedication 220:2
dedora 2:6 50:1160:5,11,18 61:2262:16
DeDora 4:8 50:959:20
deemed 161:8193:18
deeply 53:19203:3
defense 66:12263:5
defer 36:18
deferral 43:1745:3
define 84:18 125:7145:12 186:21
defined 110:15116:16 138:19242:7
defines 316:1
definitely 133:4181:19 183:2209:16 308:5
definition 7:1634:4 52:1292:13,17 93:1113:18,22 140:6159:22 231:5242:4,19 256:17312:13315:20,22
definitions
33:8,10
definitive 23:13
degree 137:4147:20 151:13191:22
Degrees 110:1
delay 54:22
delayed 278:19
Delegates 88:8
deliberate 229:11
deliberations267:22
delighted 6:1135:9
delineation 208:21210:17 257:15
deliver 81:13272:6 275:14289:4
delivered 220:7272:2
delivering 272:10
delivery 274:12275:12
demand 205:9207:19 249:12250:19 254:14
demise 43:8
demonstrate217:20
demonstrated73:10 217:5
Denver 18:6
department26:8,14,1535:14,15 109:10120:19 160:19180:17 313:4
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314:9
departments288:15
depend 214:22275:18
depended 45:13
depending 74:1884:4 105:6162:13 247:11
deposition319:3,5,8,12
depression 80:21
deprive 279:19
deprived 214:15
depth 199:19217:11 236:3241:1 253:9315:18
Deputy 17:2173:16
derived 271:19
derives 276:13
dermatology109:16
DES 174:13 175:8
describe 167:8200:18
described 29:15186:10 216:18
describes 194:16
description 130:2315:14
deserve 280:5
deserves 59:15
designation 49:20
designs 44:22
desire 312:8
despite 34:953:11,22
detail 45:21126:11 159:13196:14
detailed 27:7129:14 141:21230:2 232:7
details 28:7 55:2284:20 305:6
determination194:3 285:3313:21
determinations70:20
determine 21:485:1 203:3230:22
determined135:13 195:3261:2
determining140:8,10 195:17243:9
develop 7:8127:10 132:14211:14
developed 70:4,7150:10 220:18241:17 242:18
developing 229:12246:4
development181:15 185:16191:14245:17,21246:1,13 283:12293:20
developments
220:11
devote 223:7
diabetes 227:21
diagnose 45:10108:18 140:16183:10
diagnosed55:4,11,16
diagnosis 212:3226:6 227:15231:9
diagnostic 98:20108:16,17
diagnostically108:21
dialogue 221:6
Diane 55:10
dictate 140:8
died 55:8,15,2056:5 174:16175:6,22
diet 121:10
dietary 35:1736:12,17 37:1240:22 41:4,644:5 47:4 93:3,8231:13 235:11248:13
diethylstilbestrol174:18
differ 315:21
difference 26:198:8 100:19166:18 199:3,21239:7 273:1277:20 280:21281:4
differences 25:1947:22 82:3 239:4
249:21
different 8:8 23:524:12 32:18 58:368:19 72:6 74:679:3,882:1,4,5,1783:2,6 84:1786:9 100:10103:15,16 104:5105:3 109:2127:13 128:12150:11 152:19188:21190:12,14202:22 213:2231:3 238:6255:21 257:4,15264:8 270:14,22271:4 272:3273:20 274:15276:8 281:13283:9 284:4299:21 300:9
differentiate 33:8264:9 298:3
differentiation298:19
differently 170:2274:13,22
difficult 50:1 78:381:13 134:18285:9
difficulties 84:10
difficulty 34:22
dig 203:2
digit 28:22 29:1
Digitalis 283:14
digits 266:15
diligent 200:1
dilute 38:7 48:14
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diluted 38:3,4,8,1447:15,2049:7,8,9,11103:9,20104:1,19201:15,19
diluting 126:1
dilution 39:344:16 47:1248:22 49:5 50:3100:4 103:10,21105:10 172:9201:3,17 246:11247:10 310:15
dilutional 119:5
dilutions 38:999:11 212:18,20213:1 246:6256:1,10
DINHM 157:1
Dinley 56:1
diplomat 87:2289:15,17,2291:12 93:22
diplomats 90:6
direct 8:17 9:335:18 100:21179:12
directed 64:3140:7 228:1233:14
direction 319:8
directions 234:18
directly 54:2179:10 309:20
Director 4:46:3,1216:15,17,20 17:218:7 50:12153:20,21
178:21 203:20234:3 287:4288:7 301:1
directorate 155:17169:16 170:4
directory 205:18
dirt 175:21
disallowed 41:5
disappear 41:19312:19
disclaimer 18:1845:5 235:10,13
disclaimers 60:2
disclose 13:1443:14,19
disclosing 200:19
disclosure 29:7154:1 275:13282:5 286:9
disclosures 274:16
discontinue236:12
discovered 245:3
discovery 117:19211:16
discretion 61:16
discrimination73:6 217:4290:17
discriminatory76:4
discuss 18:12 20:4270:1 279:22305:6
discussed 215:18278:22
discusses 20:4
discussing 22:1351:17 146:6216:1 257:16
discussion 11:2221:12 87:13186:4 187:16189:13265:20,21
discussions 77:15165:12 220:19292:20
disease 41:5,745:11 98:1199:2,4 108:18109:20 122:2193:13 211:11214:12 215:10217:14,15,16224:3 231:8271:5
diseases 98:21115:4
disfiguring 34:3
disinfectant 156:3
disinfectants155:20
dismiss 69:11
disparity 23:924:11
dispense 9:1
dispensed 114:15
dispensing 176:15
display 197:22299:8
displayed 157:3
disposition 22:1726:5
dissatisfied 188:15
dissolve 151:1
dissolved 104:18
distill 147:18187:7
distinct 116:9162:5 163:6168:1 173:1186:5
distinction 48:2,1384:5 172:22197:9 209:7232:6 296:16,19297:3,14 299:4
distinctions172:19 190:4
distinguish 32:681:1,9 100:14270:8,12
distinguishable279:9
distributed 9:13
distribution192:16
DISTRICT319:20
diversity 64:12
Division 15:216:15,20
dockets 7:8 15:2
doctor 55:6 111:2120:1,2 130:14132:3 144:11147:14 199:20304:17
doctors 50:1860:20 108:7,19109:2,18 111:18112:7 129:10,11132:13 133:17
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document 88:20232:3 313:13
documentation92:10 117:4
documented 19:1626:19 45:9214:15
documents 159:18201:16 292:14
DOD 79:11
DODVA 65:21
dollar 8:14 258:2
dollars 53:15 78:5222:11,15289:13
domain 190:16
Domestic 96:1
done 60:19 66:475:7,17 82:1885:2 93:9 107:7109:12 114:11118:4 125:1145:2 147:12,13149:4 170:1191:4 246:2
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dosage 128:4212:8246:18,19,22
dose 39:5 103:22116:17,18,19,20117:4,11,16118:15,16 119:6126:20 163:18214:11 249:15273:1 274:6298:9
doses 119:7
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dossiers 226:16,18
double 85:1886:10 147:19,20148:11,13 149:8266:15
dovetail 116:6
dozens 50:18
Dr 4:11,15,206:2,3,11,1411:14,1516:4,5,8,1417:1,10 18:128:2,5 29:13,2130:1 31:6 32:133:7 34:6,945:17 46:9 48:2049:3 50:8 59:1860:12 62:17,2179:20 81:18,2283:5,19,21 84:985:6 86:19,2187:17,19 96:2297:2,3 99:19101:4,11,14,17102:14,21103:2,14104:6,15 105:16106:4,7 107:17116:1,6,9123:2,14,17127:21129:20,22
131:16,18,19,22132:1 142:21143:5,10,20144:5 145:15146:15 147:6148:7,9,14149:5,12,19151:3,12152:3,5,12,14153:1,2,4 165:21166:4,22 168:19170:11 173:3174:1,3,7175:9,12,14,20176:18,19177:5,8,11178:6,19,21179:22186:7,10,17187:2,6,21188:1,2,4,5,7,11189:2,22190:10,21 191:6196:7,10 200:12202:7,8,9203:8,10208:15,17209:11 210:19215:7,8 217:7218:10,11,16221:18233:16,19237:14 238:22245:15 247:15248:3 252:18255:7,14 256:1257:8 259:2268:6,11,19,21269:2,6280:14,16281:2,17 282:4283:3,4284:11,13,22285:17,19286:5,20 287:1
295:13,15,18296:4,14297:7,13300:1,3,4,5,14,16 307:8,9 308:22309:3 311:2316:19 317:10
dramatically211:20 272:12
drawer 73:3
drawn 282:3
drift 314:14,21315:1
drive 286:9,10
driven 82:4271:21 294:21
driving 273:5
drops 283:21
drug 1:4 4:56:5,177:10,14,16,228:15,209:1,5,6,12 11:712:13 16:2117:21 39:6,2142:6 43:444:1,19 47:6,1051:2 57:8 61:1962:2,13,14 77:2178:2 80:20 86:1090:15 91:892:14,1693:6,10,16 94:2196:11 104:13110:9 112:1113:21 114:5117:18 126:15138:6 141:13142:17 144:16145:11,13 157:2160:7,9,17169:22 170:8
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221:5,13,19222:1,3,5,19223:6,7,10,16,20,22 224:6,12225:14226:13,17 227:9228:8,10,11233:22234:1,6,12237:5,6 243:22253:15,20260:12 262:8264:20 265:7267:11
due 28:11 68:22131:13 225:5
duly 319:5
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duplicated 281:9
duration 167:3191:20 198:6
during 12:1115:17 18:2258:22 64:2 181:8205:14 246:13269:10274:14,20280:12 290:10
dutifully 174:20
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ease 192:2 267:11268:1 305:13
eased 211:20
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economy 137:13266:13
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educate 100:20139:12 187:15275:9
educated 41:1368:10 174:7
educating 294:22
education 90:5,992:6 93:19 100:2109:10 110:5,18111:11 146:12173:16 181:15185:15 220:6,7234:1 235:12248:20 257:12288:13 293:19
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effectively 53:14121:18 138:22140:13 164:20206:13 246:3304:14
effectiveness41:16 55:1 58:1459:14 60:2 61:11
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efficacy 37:1644:2157:10,15,2268:21 69:1976:15 85:8,13,2094:13 112:8117:19 121:13137:12 151:10159:11196:15,21 212:5226:21 243:10275:21276:5,11,20279:18 280:7285:21 290:1291:12 297:10300:6,8,10305:13 313:8316:6,8
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eliminate 72:1373:22 74:7,8
eloquently 117:7201:21
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embodied 228:3
emergency 19:1426:8,14,15 64:21
emerges 188:22
Emeritus 18:9
emphasize 233:8286:11
emphasizing109:19
empirical 51:1953:11 146:22
employed 90:21319:10,14
employee 319:13
employees 50:17
employs 192:14,18
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enabled 175:10
enables 192:6
enacted 235:11
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encouraged 58:16
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endeavor 154:4
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energy 129:7
enforce 239:5281:2 312:21
enforced 14:12
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enforcing 57:12
engage 226:7292:16
engaged 191:13301:10
Engagement 6:4178:22
engages 245:10304:18
England 110:22123:19 277:18311:13
England's 265:4
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enjoyed 268:4
enjoys 237:3
enshrined 161:11
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enter 15:20
entering 275:4
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entitled 135:17220:7
entrenched314:21
environmental66:13
envision 257:20
envy 134:19
epidural 274:12
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epileptic 56:2
episode 33:17
episodes 33:22
epistemological285:1
equal 81:5 279:18287:12
equally 303:11
equivalence 81:15
equivalency 197:6
equivalent 57:1661:1280:9,15,17,19109:11
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espoused 128:4
essential 39:11291:19
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establish 196:14313:3 314:8
established 59:877:21 80:11191:19 196:12212:6,9 227:13306:14 309:15313:7 316:5,7
establishes 193:20
establishing151:10 192:19229:14
establishments8:18
estimate 73:19133:20,22229:20 239:12
estimated 74:20289:13
estimates 222:13
estimation 124:1
etcetera 44:16109:14,17
158:14 297:11
ethical 149:6286:7 312:6
ethically 286:17
ethics 42:22 294:2311:17
Europe 227:4265:1
European 226:18
evaluate 143:18229:6 238:19
evaluated 58:1359:13
evaluating 1:4192:15 223:8227:8 228:7230:14 231:15232:22 312:9
evaluation 6:6,1310:13 97:6202:20
evaluations 231:3
evening 153:11
event 7:4 20:925:4,6 221:17232:14 254:5273:6
events 133:13174:6 215:10222:6 278:9286:10 297:11
eventually 271:2280:7 283:1286:13
everybody 73:8154:8
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everyone 6:3,15131:22 179:2,22
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everything 76:12125:17 130:8,14165:14
evidence 12:735:18 41:15 42:351:9,2052:9,19,22 53:1155:1 59:363:3,10 65:7,1667:12 70:2076:14,21 79:13128:10 147:1159:16,17,18,19161:15162:10,14,21163:2,7,13,15,17166:7,12 170:2171:8,22 172:16184:11 222:2279:8 280:4316:11,12
evidenced 207:20
evidentiary159:14
evolution 266:6
evolving 154:18
exact 165:15240:12 247:11
exacting 147:11
exactly 50:275:6,10 197:17198:13 199:15200:20 201:22273:1 277:12281:2 305:7308:19 309:20
exaggerated 43:9
examination51:18 89:14
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example 32:1338:17 40:2 47:1152:2 68:19 76:1378:3 80:1282:16,21 83:292:13 93:4,1297:11 99:11105:11 111:17128:14 141:15166:13 168:15170:3,12 171:12183:7,9 194:6198:5 199:8,9205:12 217:18256:8 257:3262:4,16 263:21264:5,11 265:19267:10 270:20271:16,17,22277:2 282:21283:14,16
examples 56:767:21 80:12143:16 258:22276:9 281:18
exams 108:12110:4
excellence 90:492:5,8
excellent 120:7121:10,19 196:3197:11 267:8
exceptions 230:5
excess 159:5,6
excessive 39:12
excipients 28:11103:8
excited 11:22
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exclusion 54:18
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exclusively 56:588:5
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exempt 57:8
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existing 88:15147:10 172:5225:18 232:2235:16
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expands 266:22
expansion 236:6
expect 99:4282:14,17
expectancy 269:17271:21273:2,5,16274:1,8 279:5282:10,12286:3,16
expectation 283:2
expected 118:22119:7
expenditures289:14
experience 28:829:8 112:19121:4 123:19124:16 189:11197:12,14199:16 207:16232:11 241:17246:16 271:18275:7 291:21302:11305:19,20307:14 313:10
experienced 31:15121:15 133:9289:21
experiences302:12
experiencing17:14 305:7308:5
experiment118:19119:12,13
experiments 118:9119:11
expert 35:22 56:2163:21 95:2125:15,16 293:6307:1
expertise 128:13
experts 71:7 90:194:9,20 95:6108:8 226:8238:16
explain 33:13100:3,4 113:6145:5 148:10151:9 218:3,7282:3 286:12
explaining 58:7
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explanation 42:1146:6 310:21
explicit 214:4215:5 218:8
explicitly 282:1
explore 240:22241:1
explored 273:19
explorers 95:14
exploring 205:4208:2
exposed 22:1525:3 118:14
exposure 19:8,1620:7,8 21:522:12 23:18,2024:1,20 26:731:22 54:7221:16
exposures 18:2019:2020:6,12,14,1521:15,2022:2,5,7,9,10,1523:2,824:4,6,12,1525:5,8 26:21,2228:10 30:18,1933:2,11221:18,21253:1,4
express 206:14305:4
expressed 44:14294:1
extended 163:3
extensive 51:1877:18 94:10110:1,4 189:13
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extent 41:3 190:1200:18,22241:21
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extracted 25:16
extracts 39:19
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extreme 211:12,21
extremely 24:7191:22 206:13241:19 251:6308:12
eye 33:17
eyelids 175:3
eyes 249:6
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303:20
faced 187:9
facilitate 221:11257:12
facilities 201:14225:15
facility 27:1154:11
facing 204:2,10,15207:22 252:4290:20
fact 32:9 54:1756:19 75:1676:10 82:16146:21 159:2
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factor 119:5172:10 207:1239:14
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facts 234:19255:20 299:9
faculty 173:10
failed 135:5 246:1
failure 53:22
fair 158:17 164:3183:8
fairly 96:14111:17 181:18182:5 184:13,22185:16 186:2
fairness 35:8
faith 125:13,19126:4
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false 139:7
falsities 64:11
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familiar 33:4184:9 246:18247:1251:6,7,8,11277:4 306:5
familiarity 184:8251:4
families 208:3261:4 264:13306:18 307:4
family 35:1564:1,16 128:16175:16223:11,14259:12,18260:15 261:6265:4,16 268:2302:3 304:1307:16 308:11
fantastic 60:5
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fascination 265:2
fashion 116:20
fastest 266:12289:19
fatal 211:14
fatalities 25:1527:5
fatality 26:1 34:5
father 152:15173:14 175:16310:11
fault 76:19
favor 72:11 148:4151:5
favorable 95:19252:22 254:20280:1 290:5
favorably 112:6
favored 72:9,10
FDA 1:13 4:47:13,18 8:79:8,14,15,2110:7,22 13:814:21 36:15
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FDA/CPG 193:11
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fear 141:5 145:3303:10
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feeling 208:19,20210:15
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fever 4:19 210:21211:7 215:12216:15217:14,21 266:2
fevers 265:8
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field 66:6 88:1189:5 94:1 95:7117:1 152:16177:18,22282:9,12 291:21
fielded 229:16
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fill 74:3
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finally 26:3 55:22237:8 270:1293:8 317:9
financial 13:5,6,1451:1 176:13211:5 259:9
financially 311:7
319:14
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finding 66:1 73:11205:19 251:2
findings 52:3117:15 118:10250:18
fine 151:22
fingers 175:3
finish 86:7
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firm 240:8
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first 17:20 22:1924:22 30:7 36:465:10,13,14 67:584:17,22 90:1497:15 113:17117:3 118:17136:17 162:8,9164:2 168:1,18173:20 177:13180:2 181:21189:15 193:4195:19 196:8208:6 219:21221:16 229:22237:2 246:17255:8 256:14258:5 260:17261:5 262:2263:5 275:17296:8 301:21302:8,17 307:11
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flashes 14:1
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form 52:16 144:14212:15 213:7246:19 255:17310:18 314:3316:12
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formulation 193:1200:15 247:3
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forth 9:16 75:14103:11 167:14190:5 195:12201:20 208:22281:19 302:7
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Fraix 2:13 4:15179:19,22 180:8186:17 187:6188:1,4,7 189:2190:10
frame 171:5275:13
framework 1:5155:5 156:17,19157:15 162:6,20163:7 165:18168:6 192:6195:13 197:19219:11 220:20249:5 253:13254:21 307:2
frameworks 165:8
France 136:18,21137:5 143:17264:22
fraudulent 42:20
free 108:2 179:12206:1 235:22267:15 278:13310:7,8
freedom56:14,15,16
French 137:3,4264:20
frequency 289:11
frequent 251:12
frequently 91:14200:5
friends 12:21223:11,17301:12
front 17:16 27:2093:22 95:3 143:1197:22
frustrated 145:16
146:2,10
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FTNC 253:21
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fulfill 51:15 110:4
full 20:18 29:6109:4 154:1250:16 287:13290:19
fully 56:15,17110:16 291:5
functional 46:22
functioning 34:18
fund 176:4
fundamental46:10 56:1967:19 140:11
funded 18:1263:14,20 252:20
funding 66:3204:8
funnel 72:21
furthermore 53:3206:7 298:21
fused 175:3
future 73:22252:12
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gag 303:14
gain 10:16 176:13311:7
gained 278:12
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gamut 169:18
gaps 63:8 267:3
gastrointestinal199:10
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gathered103:13,15
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gee 75:11,13 76:1
general 13:3 23:690:9,10 99:15100:7,8120:19,20 125:6137:8 153:20161:5 166:18169:12 170:5185:6 201:7204:11 222:19225:4 226:19241:20 247:2,3282:9
generalizability117:17
generally 21:433:22 38:1 60:3104:8,15 158:20169:18 183:5189:5 193:21221:22 227:12228:6 246:17
generated 312:14
generation 260:17
generations 174:5265:5 268:2
genes 178:3
genetic 211:11214:12
gentile 14:7 87:4
gentle 261:10262:20 263:3,5
gentlemen 237:14
gently 206:12
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gestational 174:17175:5
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getting 23:21 33:669:20,21 71:1981:3 128:19171:2 316:22
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gives 22:8 23:15153:5 198:16264:18 303:7
giving 31:1 63:397:12 130:2217:18 229:2263:8
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glandular 39:19
glass 246:8
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150:7 168:9,12
GMP's 238:11
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goal 51:8 94:16151:1 237:11269:20 275:16277:14
goals 220:9
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gone 134:10
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government 52:18135:12 137:11145:20 164:7173:17 292:11
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GRADE 70:12
gradual 82:7
graduate 109:5111:4 301:22
graduates 132:8
grandmother175:12 260:5
grant 18:12
granted 226:20
graph 72:7
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greater 23:1031:1,17136:10,12 142:5249:10 289:21
greatest 54:12121:12
greatly 10:21 43:9206:14
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groups 23:1084:17 278:8
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grown 205:2262:16
grows 266:15316:15
growth 51:4 82:12118:20,21119:6,7,8 138:6176:11 205:11222:18
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grueling 150:3
guess 76:18 128:2170:17 187:8189:22 203:14218:13284:2,15,20297:7 316:4
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guide 7:22 8:99:17 11:2 96:10192:22 196:3220:16 224:19225:17 226:2230:13 231:6234:11 237:2253:16288:17,18 292:1
guided 233:2291:18
guideline194:16,21 195:7235:4
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guideposts 129:9
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guiding 220:21
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guy 118:1 119:2
guys 237:15
gynecology 109:16
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habits 244:13
Hahnemann144:5 153:7177:17
Hahnemann's177:1
half 23:7 65:21130:21,22131:14 134:4154:2 169:10180:19 228:20251:7 317:14
halfway 174:16
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halt 55:14
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hand 77:5 119:3237:18
handout 143:12
hang 154:7
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happened 71:3
happens 26:369:13 86:14102:2,7 104:3150:22
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121:3 154:22169:11 170:9201:11
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harm 11:4 51:1154:2,3,12 55:2
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hear 35:5 79:287:12 106:11147:5 150:15154:9 160:17176:8 179:4203:11 262:21265:3 268:7286:21 317:15
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helping 96:18132:22
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herb 47:14 93:4110:9
herbal 47:13
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highly 38:2,1449:4 88:4 96:16301:9
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histology 109:14
historian 42:10
historically116:19 258:8
histories 108:11
history 129:14144:11 160:11163:3 174:22283:12
hit 129:16
hokie 126:7
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187:11 188:19189:7,19190:4,12,15191:11,15192:4,7,17,20193:6,8,12194:17195:2,9,14,21196:1,16197:3,9,20198:1,2,3,22199:2 200:2,16204:8,13205:1,8,20206:2,9,11,22207:9,10,18208:5,7209:1,9,18,19210:6,9 211:2212:12,14,18213:1,11,13,14214:5,17,21215:2,13,19216:19 217:5218:5,19219:1,2,6,12,16,17,19 220:12,17221:5,11,12,19222:1,3,5,9223:5,6,10,16,20224:6,10,12,13225:6,14226:8,10,13,17,22 227:9,19228:5,7,11,19229:1,21230:4,6,15231:9,15233:4,9,12,22234:1,4,5,6,10,12,15,22235:2,6,21236:6,9,15237:5,6,10238:10,14,16
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homeopathy's41:15 43:8
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homeotherapy143:8
homepathics139:4
homephath 78:19
homesis 118:7
hometic 116:12,13118:14 119:14
homotoxicology152:16
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hope 7:3 9:2010:16 79:10126:6 145:9146:17 154:2,8167:16 253:10267:22
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hormone 125:5
hormones 118:12124:15
hospital 138:2
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HPIS 227:11
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huge 150:13
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hundred 49:9,1064:10 95:12222:14
hundreds 78:5
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IHPC's 292:22295:2
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inclusion 42:5,1843:11 52:7
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increase 82:7151:2 273:11
increased 36:15205:9,14,16,17
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increasingly263:13
incredibly 310:9
incremental 82:12
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individual 37:148:11 83:13137:14 142:2,10152:6,19 227:4243:12 247:9249:14,16 291:9296:16 297:8
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individuals 56:14147:13 185:22213:10
inducing 117:9
indulge 17:12
indulgence 34:20123:4
industrial 247:5
industry 6:20 8:14139:5 145:22160:15 161:1164:22 196:1204:9 205:2219:6,16220:19,22221:10 222:9,17224:21 226:4227:6 231:13237:10 241:18248:20 266:14294:21 302:19
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inherently 40:18
inhibition 116:18
inhibitor 118:20
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initially 129:15
initiative 290:21
Initiatives 4:16191:1,9
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injuries 265:10
injury 66:11 98:15
innately 37:10
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inquiries 179:13
inquiry 4:8 19:1650:9,10,13,21,2259:21 60:13192:11
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inspections 158:14168:16 254:1291:5
inspectorate158:12,19 159:3167:10
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instance 54:4296:11
instances 11:3258:15
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integrate 65:1181:2 182:11183:17 189:7
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integrative 4:125:4 36:9 52:2179:15 131:21184:14 266:7286:21287:4,9,12,21292:17 303:22
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intended 193:13233:10
intense 96:5,6
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intentional 21:523:19 24:5,11
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interactions110:9,10 115:7206:7 212:8
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intermediate201:4
internal 36:665:18 68:2076:17 232:15,21261:2
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internationally173:10 311:21
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intrigued 265:3
intrinsic 279:6
introduce 12:1616:3 17:10 35:9
introduced 211:18301:21
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introductions222:20
intubation 303:14
invasive 277:3
inventor 177:17
invest 77:7
investigate 177:3
investigation202:20
investing 77:9
investment 74:21
invitation 269:7
invited 180:1
inviting 154:13
invoke 43:13
involve 23:3 71:7181:5 183:11,12247:12,13
involved 27:8148:15 202:12311:17 315:1
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January 121:21
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job 17:12 107:7125:17 134:18151:13,17
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joint 70:15
jointly 139:10
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journal 116:14137:7,22 277:18294:15
journalist 259:11
journals 66:1673:8,12,14 173:8294:13
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judged 137:17
judgment 69:970:16
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June 15:10,14253:11
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labeled 6:187:14,198:1,13,16,209:12 10:4,8 37:640:7 46:12,17,1948:16 90:16 91:693:17 94:1296:12 100:13112:2 114:22115:3,20126:15,20141:13 146:4182:1 184:19209:18 212:14227:10,19 233:5234:16 237:6289:7 292:7293:11 298:7,8299:13 310:7312:12
labelers 222:5234:12 241:20242:1,21
labeling 8:4 10:1436:14 46:1057:18,19 59:1163:5 95:8114:9,10 115:9126:18127:19,20 139:1
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labels 45:22 46:273:11 161:3197:21 215:5235:9,15 258:7313:1
laboratory 65:1366:7,11 69:21108:16 116:7
labs 65:22
lack 45:12 56:858:19 131:12243:2 280:7286:13
lacked 43:6
lacks 226:4 276:4
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laid 105:2
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laptop 283:18
large 74:14 187:7189:3 205:3217:16 248:17276:17 279:1298:17
largely 307:11
larger 83:11
large-scale 86:17
largest 111:3204:14 259:15265:17
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last 31:16 34:652:3 70:4 71:475:4 77:15 79:183:19 93:14118:8 120:5132:20 133:20159:2 161:14166:2,6 171:22173:4 205:2225:3 255:13,18263:10 269:10280:12 316:4,20
Lastly 56:1 181:14
late 55:11
later 55:9 60:9
latest 75:15 136:7
Latin 44:7 177:2211:16 270:6
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leading 90:1133:22 219:15237:9 267:15
leads 217:2
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learned 74:10152:14 221:17278:3,16
learning 128:20
least 27:13 53:1859:10 256:20279:11 285:12
leave 165:19 179:5
leaves 91:22
leaving 92:21
lectured 111:8173:10
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legacy 175:18
legal 135:17138:14 232:16
legally 258:18
legislative 62:7
legislators 287:10
legislature150:17,19
legitimacy 270:2
legitimate 316:17
length 226:2
lengthier 61:8
lengths 310:3
lens 289:3
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let's 22:19 24:2245:17 67:8 79:2080:10 143:1,3157:11161:13,14190:13 229:15237:17,18268:12,15276:12 277:2295:16
letters 141:4,7144:22 225:4,7231:12 312:15
letting 142:19
level 166:6,20171:10 201:18207:1 253:7257:1 267:5
levels 38:16 46:2247:14 172:4202:22 230:10231:21
liaison 293:6
license 108:14157:21 161:18
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lieu 215:13
life 34:3 53:9 88:2114:17 115:3120:13 121:19122:2 135:4211:13 214:16295:11
life's 144:8
lifestyle 109:20121:10 131:2267:16 301:15
lifestyles206:12,21
lifetime 305:12
light 14:4,8 63:9138:5 172:1192:14
lights 106:16
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likeness 170:6
limitations 182:7184:11 185:18
limited 13:17 28:729:9 41:20 93:797:9 116:20304:12
limiting 115:22193:13 206:3231:8 294:20
limits 170:21171:7 285:16
line 86:7 98:19167:5 263:5272:17
lines 93:22 95:3
linguistic314:14,21 315:1
links 265:20292:13
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longer 140:5
longitudinal 69:1986:17
longstanding123:21 235:4
long-term 78:15
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lots 120:11 127:13165:1 317:11
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lovely 175:11
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lower 158:20171:2,4
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lozenges 38:19
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lucrative 176:10
lump 190:11
lumpectomy 55:7
lumped 170:4283:10
lumping 84:7
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magazines 8:17223:17
magnitude 117:13271:3
main 67:10 81:19297:19
mainly 11:3
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maintain 94:19121:19 164:21205:18 225:18
maintained 88:4
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manufacturers28:19 92:19 93:5132:13 141:7142:17 149:21150:8 151:8168:11 176:21219:17 223:22
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marked 75:1198:22
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marketers 239:18
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Mass 120:19,20
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massage 260:3287:19
Mass's 111:2
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master 148:15,22149:10 202:5
master's 269:10301:18
match 66:20 67:2305:8 307:18
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material 133:13136:15 202:1238:6,8 246:11247:13 252:11
materials 238:17239:7 246:7
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means 25:1 39:649:7,9 76:5132:2 164:15,20169:19 177:2189:4 251:2270:7 314:15
meant 33:13 68:12284:7
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mechanistic 78:17
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mediated 117:10
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medical 4:7,1219:17 29:435:11,16 42:1,1452:4 53:7 64:390:17 108:2,18109:5 111:9,14120:10 129:10131:21 132:3,8133:15,19135:3,5,15136:14,16137:2,4,7,13144:10 145:19
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medically 279:14
medication 24:356:3 188:3,5210:9 216:19244:2 272:10
medications 211:2283:13 303:6,16307:5
medicinal 35:17
medicinals 257:17
medicine 35:15,1836:4,5,6,7 51:1252:16,21 59:564:9,14,16 65:1876:17 79:14 86:388:16,1989:3,6,17 96:297:20 98:399:1,21 101:20102:12 104:4,18107:21 108:9,20109:22 110:15111:16 126:10131:1135:18,19,22136:4 144:14157:1,2 161:22163:1,2 172:9179:20180:11,12,14183:21 184:3186:13187:10,11 189:7
190:13 211:8245:14 257:4261:14 263:19264:1,15266:6,7,8 277:19279:3 280:5282:16 288:3298:9 299:14304:2 314:3
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Mediterranean4:19 210:21211:7 215:12216:15217:14,21
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mediums 235:22
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meeting 10:1812:3 13:814:16,18 51:357:9 116:9179:16 196:6249:1 258:4
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mention 132:9174:13
mentioned 9:1646:11 75:8 76:1083:6 110:22127:22 143:5,16202:10 207:21217:9 240:5,20269:14
mentioning 98:6
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micrograms 44:15
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microphone 14:5
mics 106:14
middle 67:9
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midwives 287:19
mile 310:10
military 64:2,1965:19
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milliliter 44:15
million 21:19,21137:21 173:12222:14 258:2
millions 78:5288:1 316:14
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miscarriage174:19,22
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missed 76:11217:9
mission 10:1204:15 219:22220:4,6 253:18257:12 287:11
mistake 215:5
mitigate 45:10187:5
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mixing 125:22
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modalities 150:12302:16
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non-OTC 225:5
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observation119:11 169:12275:8 279:1
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obvious 25:240:13
occasional 265:10
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occurrence 278:8
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organize 15:7
organizing 219:9
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original 38:1149:15 243:17247:13
originally 101:19
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outlined 159:17
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pharmaceuticals21:21 22:2224:10 25:1826:2,11 30:1632:4 129:11197:13
pharmacies 8:22124:19125:12,18149:16,20 262:7315:6
pharmacist 21:3124:5,8,9 126:9228:17 233:21
pharmacists 4:2194:22 110:12111:13 112:13113:13124:12,14218:19 219:1223:17 228:19234:4 235:19245:19,20296:10
pharmacologic47:14
pharmacological63:17 79:15
pharmacologically 38:16 47:948:21 49:4256:11
pharmacology35:14 110:8
pharmacopeia39:16 42:6 43:1247:8 95:1 112:14113:14 147:4163:20 166:14176:2,5 194:15200:16 219:3224:13238:15,16243:13 291:13313:12
Pharmacopoeia7:12
pharmacovigilance 202:10 203:7
pharmacy 8:1918:10 37:8124:20 126:3127:14 137:5145:13 197:3235:21 260:11307:21
pharmecodenomic 271:19
PharmedOut35:19
pharmicovigilence 222:8
pharmocodenomic 274:4
PhD 116:10 269:9301:18
phenomenon81:11 116:17269:15 270:11271:1,3 273:4282:7
Phillips 2:18 4:20218:17 219:13233:16,19,20238:9 255:18
philosophical164:12
phitomedicines40:21
Phoenix 132:11149:4
phone 207:14240:7
phrase 300:5,7,13
physical 108:12180:10,12,13267:13 305:11
physician 26:1642:9,19 63:1264:1,20 87:2091:22 95:2,2196:1,8 98:10104:16 120:17122:12 129:3,4167:8 177:20180:9 181:11216:17 260:10269:9 281:6
physicians 4:1042:13,15,2164:5,20 87:16,2288:1089:5,6,9,18,2190:6 93:19,21107:5,13108:8,15 111:6112:15,20,21124:14 132:7137:3 223:20,21224:1 287:20,21313:10
physics 52:15
physiological275:19
physiology 35:14109:13 118:18
Picha 55:10,13
pick 74:19 200:10217:2 284:6
picked 82:19
picking 24:2
picks 75:11,12
picture 41:17
piece 100:16 242:1
pill 212:15
pills 176:15 271:8303:15
pilot 247:4
pioneer 260:14
Pittsburgh18:7,10
pivotal 234:13
placebo 51:2166:8 71:18,2172:10 77:278:4,7 79:480:22 81:4,985:18 86:8176:15269:11,14,18,22270:3,4,5,9,10,12,13,14,17271:2,7,10 273:2274:5 275:10,17276:1,9 278:15279:9,13280:8,11282:1,17,18,21284:7,9 285:7,13286:3,6,10
placement 197:2,7208:22 257:19
places 111:8
plain 58:12 59:12
plant 44:7,8 47:11
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plants 35:17118:13,20 119:6238:6
plasticity 117:14
platform 237:4
play 116:16164:18
played 43:2
players 165:12
playing 187:5
plays 187:3
pleading 55:22
please 17:12 19:160:10 113:6186:6 189:20247:18 317:4
pleased 192:10
pleasure 18:3116:9
plenty 317:5
plot 72:21
plus 88:14 274:5294:9 296:12
pocket 289:13
podium 12:15233:16 259:4
point 35:3 49:1371:7 84:9 105:17111:19 114:12126:13 147:9150:21 163:2164:2 166:17,21181:18182:17,21185:11 186:5203:15 210:11
221:4 231:17278:1 285:2297:19
pointed 42:11
pointing 217:8
points 221:13,14237:1
poison 4:5 17:2118:6,7,13,1619:3,4,5,10,1920:2221:1,2,11,1722:11 23:2,826:9,13,1727:14,17,1928:20,21 29:230:931:14,15,19,2233:5 54:5 221:21224:7 236:2,7252:16 253:6
poisoning 18:2019:7 20:8
polarized 183:1
police 106:17
policies 7:21 9:1610:13 138:3192:13 195:17224:17 240:3307:2
policy 5:4 7:22 8:99:17 11:216:6,13,16 48:250:12 115:17159:18,19161:7,10 179:15192:22 193:16219:7 220:16224:19 225:16226:1 231:6234:11 237:2253:16 286:22
287:5,10 288:17292:1 311:18
poly 127:14
polypharmacy36:22
poorly 75:17
popular 67:17264:22 305:15
popularity 207:20
population 96:19276:17 289:19
populations136:10,11249:19 293:2
portion 136:15204:14
pose 212:12
posed 90:13111:21 132:17229:4 233:18248:22 306:10
position 18:8197:8 299:1
positions 110:21
positive 41:1872:18,22 73:775:12 112:22128:1,6 162:17206:9 212:2275:1 289:8
possess 259:19
possessions 95:18
possible 21:10110:11 129:18151:6 245:22275:10 285:6,13312:21
possibly 172:11
post 109:5 111:4121:4 157:18158:6 195:9272:18
post-doctoral110:4
post-operative272:15
potencies194:17,20200:16 313:14
potency 37:2138:5,13 47:2248:3,8,13,17170:15,16,19171:3 175:10195:7 283:21
potent 38:4,5
potential 10:1124:14 48:2105:12115:11,12116:22 117:18182:7 216:6260:18 279:20280:3,8
potentially 39:20114:17 115:3180:7 183:16,22186:20187:13,19190:19 221:8258:5
potentials 239:14
potentized 312:4
pound 175:2
pounds 55:20
powder 156:10
power 80:16139:11 140:20
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powerfully 304:3
practical 183:7
practice 36:2042:15 65:6 70:2186:15 88:5 99:20100:21 110:3112:4 115:15123:21 125:9130:20 131:14132:11,19133:3,9,11135:20 149:15174:1 175:20181:3182:4,10,20183:8,20 184:21223:21 264:21276:6 287:21291:7 294:1306:5 313:9
practiced 36:2242:13 110:14
practices 36:237:19 64:1067:18 91:13110:20 115:9138:11 239:9267:4 291:16
practicing89:16,20 95:398:9 115:14
practitioner 100:8104:9 114:16128:5 131:9148:11 204:21236:13 279:15
practitioners 8:2264:7 111:12124:20 126:8130:11 131:4133:20 134:13
135:2 137:9160:14 165:1176:22 190:15204:14 205:20211:3 267:7275:9 288:11290:7 291:8295:22296:6,12,13311:11 314:18
prayers 120:6
pre 8:1
precautions 40:6
preceding 246:1
precise 284:5
precisely 283:22
predicted 119:9
prediction 74:1275:21
preemies 175:4
prefer 13:13 250:8
preferably 85:19
preference 249:14
pregnancy174:16,21 175:7259:22 274:11
pregnant 175:16
prejudices 150:22
preliminary 7:6
premarket 11:6155:4 156:19157:18 159:9226:14 227:1,4
premiere 265:15
premise 140:12
preorder 15:1816:1 178:12
preparation 38:8213:13 218:5229:16 256:13295:20 313:14
preparations36:15 38:13,1540:1 43:19
prepare 294:18
prepared 54:14125:9 185:7186:12 250:18
prescribe 91:4104:16 126:12127:12 216:20
prescribed 42:1948:9 56:3 91:9124:5 128:6137:3 174:20185:10
prescribing 35:20102:12 110:17115:14 130:5216:18
prescription8:12,209:1,4,11,1210:21 16:2129:18 30:1532:3,7,8 37:238:6 40:1,4,1244:18 48:984:1,2,3,691:3,10 104:13123:22 141:1155:17,19 156:3160:9,17 168:14169:4,22 170:8172:20 173:1194:19 214:13215:13 219:8222:19 226:3232:20 261:15
prescriptions304:16
prescriptive159:16
preselected 83:15
presence 43:10
present 6:1113:1,21 14:21107:1,11 123:1255:6 276:8303:3
presentation12:9,12,1913:10,15,2214:10 19:122:1,18 28:6166:5 169:2170:12 181:9,17196:11 215:9228:13 238:1240:20 242:4281:20 297:4
presentations13:17 221:15
presented 25:2027:16 234:19
presenters 6:21242:12 298:21
presenting 22:332:16 218:21234:2
presently 231:10
presents 91:2
preserved 112:12
President 62:18107:13 108:1134:3 150:15177:19 211:6218:22 219:4248:9 311:9
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Presidents 173:16
presiding 12:10123:4
press 179:8,10
pressed 154:9,10
pretty 25:2 42:12199:18 309:13316:2
prevent 45:1057:11
preventable211:15
prevention 109:20
previous 97:1098:6 209:13
previously 172:8229:20
primarily 67:20180:22 204:10205:13 275:22
primary 77:19110:16 195:6223:15 302:15
Princess 265:2
principal 299:8
principals 52:1391:5
principle 102:11197:22 219:21280:4
principles 36:644:11 56:20140:7 147:3247:2 310:16311:16 312:16
prior 15:16 37:2144:22 169:2190:3 195:8208:5 231:19
288:7 301:15
pristine 121:10
private 112:4132:10 248:17
privately 248:18
prize 118:6 148:2
proactive 208:8221:6 263:13
probably 24:1437:14 49:1477:19 107:7120:13 130:21131:13 157:7177:11 238:5242:18 243:21245:12 258:1
probe 256:22
problem 46:15,1753:21 73:1577:11 187:3217:8,11 225:12
problematically61:2
problems 48:15105:12 112:17115:22 122:14
procedure274:14,18,21275:6277:4,10,12
procedures183:12 285:8
proceeding320:6,7,10
process 9:6 28:1329:15 60:2070:22 89:1395:17 103:9117:20 138:19139:17 146:20
151:10 166:9168:10171:17,21172:13 184:6192:19,21193:19,20 194:2200:14 201:4202:20 227:8228:4 233:3241:4 243:10247:8,10 275:12
processes 10:1370:9 75:18192:14 200:22227:1 229:5230:22 247:12275:11,13
produce 223:22239:2 282:13
producers 239:3
product 1:3 16:1620:5,11,15 21:1922:529:3,5,6,17,1831:3 32:22 39:1044:20 45:647:17,1948:8,17,18 49:658:13 59:1385:21 93:7,994:6,7,8 99:17102:17,20103:16 112:10113:2 115:2122:11 124:22125:8 127:9130:8 139:1147:1 152:19,20156:7,8,16,21,22157:19,20,21158:2159:4,12,22160:6 161:3
162:11 169:16170:7,20171:9,16172:2,14 191:11192:17,20193:4,5,12194:13 197:15198:2,3,5199:2,4 200:10201:2,10 208:22209:9,18210:1,5,9,12214:1,2 215:13216:14 218:8222:20 234:13238:3245:7,16,21246:1,5 247:6,7249:9,18 251:2256:8 257:19258:16 262:21266:14 267:3288:12,15294:16 296:5298:6,13,20299:9 306:22309:18 310:6313:18
products 4:226:18 7:14,15,228:2,15,209:1,5,12,19,2110:4,5,8,12,14,19 11:1,5,7,1116:21 18:1422:22 23:6 28:1029:10 30:14,2132:14,17 33:1037:12,20 40:2143:4,5 44:745:1446:1,11,16,18,2247:2,1148:1,3,11,14,22
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205:8 206:9207:9,18 209:1212:12,14,17,21213:4,7,9,20214:21 215:3217:5 219:19221:8,21 222:5225:2,12 226:10227:10,12,17,18,19 228:1 229:1,7230:4,6,9,15,22231:6,10232:10,15233:5,9,12,13,15234:10,15,21235:3 238:5239:3,11,22240:13,15,17241:6,7242:15,22 243:8244:16 246:17247:3 248:5,10249:3,4,7,13250:14,21251:5,10,11,22252:7,15,21253:14 254:3,19255:2 256:16,17257:10,18259:21261:3,5,10,18,20262:2,3,5,12,20263:2266:11,16,20267:17,19,20283:14 288:11289:1,7,10,12290:8,13291:2,16,20292:3,7,21293:11,15294:19295:4,6,10,21296:22 297:22298:2,4,6 300:8
302:10,19306:13,15307:11,22308:7,13,14,20309:4,7,20312:12,19313:15,21
profession 42:14110:16 133:7312:16
professional 6:426:18 39:4 108:5123:6 178:21206:18 217:4250:8 280:3287:19 291:21293:20 311:11317:17
professionals37:15 91:1293:20 205:6223:18 235:20236:5 287:14306:21
professions 90:18289:1 313:19
professor 18:935:13 64:1571:10 117:21119:1 180:15211:8
profile 112:9252:22 254:20
profit 204:6 287:7301:17
profound 263:11
prognosis 99:2120:7
program 50:2070:15 111:4158:11 215:15
220:6,9 222:7
programming288:13
programs 66:10142:8 203:13
progress 131:12286:19
progression 224:3
project 35:1988:13,14 89:1103:5
projected 222:20
projects 66:3,5
prominent 115:4
prominently58:10 157:4197:22
promise 300:20
promote 9:22138:5 221:1244:19
promotes 35:1950:14
promoting 56:11204:6 288:18
prompt 179:3
promptly 178:11
promulgated141:8
pronounce 34:14
pronounced 34:14190:22
pronunciations100:10
proper 91:9139:12 145:7174:7 209:3
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properly 54:14115:19 140:3147:17 151:13236:8
properties 90:19
Proponents 56:12
proportion 270:21
propose 43:2251:12 57:1
proposed193:1,3,4 200:14
proposing61:14,17 118:3
proprietary200:19
prosthetic 284:1
protect 9:22 51:1557:13 134:16138:4,14 221:1224:18
protected 122:5138:9
protecting 53:2059:16 237:11311:19
protection 59:6
protein 156:10
protocol 101:8308:8
protocols 246:5
proton 199:11,21
proud 175:12
proven 54:18127:5 214:9247:7
provide 25:1127:7 45:20 93:1994:11,17 97:6
110:6 139:13141:17 142:9154:13 163:17164:8,11 166:12183:3,5 184:14189:5,17 192:11204:11 211:1215:4 217:18218:1 219:10228:14,22233:17 236:4252:2 254:11267:21 275:21277:2 278:6287:22 293:1294:17 298:1316:6
provided 8:2140:14 142:1182:18 211:2256:21 264:11292:14 305:22307:3
provider 10:1090:15 91:21181:22 187:17223:5 237:7289:6 290:14,16302:9 311:20
providers 50:690:10 92:7 93:1594:3,15 110:16111:6 112:1114:19,20120:18 141:11142:5,16 152:8184:17 185:14207:4 223:11287:17 290:4,9291:6,15 292:20293:9,13,14295:3,7,9
provides 39:6
92:19 138:20141:2 196:3232:5,7 234:11
providing 7:525:13 90:4 92:6158:13 204:16208:10 220:22224:20
proving 39:1588:17 101:19102:5 128:3139:22146:19,22147:1,11,17148:10,16 149:3163:19 177:15
provings 98:199:12 173:13
provision 290:18
proximity 197:4
prudent 263:8
Psychological78:7
psychosocial281:7
public 1:6 9:20,2215:1 50:12,1451:16 53:2056:20 57:1358:2,1959:1,7,15 87:1990:10 93:2196:10 99:15107:21 108:3111:3 115:21122:18 123:7134:6,16138:5,8,14,17139:13 142:3144:19 145:8146:13 152:7191:10 192:1
203:22 221:2224:18 232:4237:11 253:17288:19 311:6312:1 313:2,22314:4 319:1,20
publication 72:1774:5
publications 20:1778:1 88:18
publicly 248:17
public's 56:8
publish 73:12
published 25:1327:1765:10,12,1466:16 71:6 72:1973:14 77:1779:14 82:8116:11 136:6232:10 233:2,6260:9277:9,18,19278:21 280:12294:13
publisher 259:13266:4
publishes 19:22
pump 199:11,22272:6 274:6
Pura 88:13,2197:4,16 103:5
purchase 91:1599:16 124:18210:10 213:10
purchased 124:17213:21
purchasing 41:13207:17 209:9215:18 253:7
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309:5
pure 261:21
Puri 118:5
purity 37:21101:6,10 102:19103:7 167:13
purport 79:5
purported 213:2
purports 99:10199:3,7
purpose 88:14246:20
pursued 55:19
purveyors 214:21
putting 83:22
Qquack 43:10
qualifies 39:16
quality 16:16 17:928:11 36:1637:21 41:2044:21 60:1666:1,19,22 68:272:1,3 82:2083:1 93:19 94:18112:10,11,17121:19122:11,14133:10 139:1142:16 156:4167:13 200:21201:8 223:22226:20 228:9237:6 238:3,8,19239:6 240:13,18246:14 254:7255:1 279:1288:2,4,14,15,20,22 289:2,3,9
290:10 291:20292:21 294:5295:10,11302:18
quantitative117:10
quantities 44:13
quantity 49:17289:10
quarter 251:5,6
Quarter-Century1:5
question 12:1029:14 30:8 31:632:1 34:7 60:662:1,8 66:2067:3,568:4,13,2174:14,22 75:2277:10 81:17,1883:12,1984:18,2285:7,9,20 86:187:9 90:14 92:293:14 97:8,1698:4,5 100:6101:18 103:1,4104:7 105:13111:22 113:3123:9,18125:3,7,11 128:9130:10 131:15135:7 138:3,15139:14 145:9146:16 148:8149:13 151:4152:4 167:18168:7,18 173:2181:21 184:16189:2 190:10197:12 202:8204:19,20 207:3209:6 216:5
223:4 224:4,16225:20 226:9228:15 229:4,9231:20 233:17234:8 237:16238:1,10 239:1244:5 256:12258:2,3 260:22266:19 268:12276:4 278:1282:20 283:6,7285:18 289:5292:4,12296:11,14,15,20,21 298:11300:3,4,6,12306:10
questions 7:6 10:814:13 15:8,1328:3,4 45:1959:20 67:10,1969:17 79:2287:3,12 90:11,1394:2 95:4,897:1,3 100:1,9111:21 123:16129:14 132:17142:22 154:3165:22 166:5167:1,17177:6,10 179:13181:13,19186:6,8 196:8204:17 208:16223:1 229:22230:1,2,21235:21237:13,17 240:7248:22 250:10255:12 258:11259:2 260:19268:13,19279:12280:15,17
288:21 293:8296:13 300:14302:7 307:6315:19
quick 97:3 151:4152:3 167:1187:21 244:4280:18 288:6
quickly 13:1121:17 215:20256:13
quite 23:5 65:174:8 81:7 118:4122:2 154:22166:21 172:10177:18 183:1201:20 255:18279:5 282:18285:7
quizzical 30:18
quote 117:7 231:7290:2
Rracks 37:1
radiation 118:11120:11
radiology 109:15
raise 119:2
raised 88:3 160:21176:3,6 229:3301:14
ran 64:8,14
Rand 70:13,1579:16
randomization86:6 274:15
randomized 69:1871:18 77:2 78:14
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85:17 277:17
range 117:14156:9 162:16198:16 226:4243:3 245:9249:7,12 250:19252:1 254:14287:13 303:22304:15 309:10315:7
ranges 262:4
Ranked 136:6
rare 189:8217:14,16
rarely 54:15
rate 136:17221:21,22222:18
rated 136:21
rates 26:1 32:19
rather 81:14156:12 159:17170:1 251:22317:12
rating 272:16
rational 35:20
rationale 30:20
raw 32:19 238:6
RDA 38:20,21
reach 220:13
reaching 117:3
reaction 19:8 21:6303:10
reactions 23:1924:18,19 303:1
reactive 127:10
readers 268:3
readily 142:3152:6
reading 258:7308:19
ready 274:12
reaffirm 195:11
real 19:20 69:2,370:9 119:12137:12 216:20281:19 292:20
reality 187:8
realize 29:5
really 11:1112:12,19 31:2132:11 48:15 63:571:12 86:8 97:1798:22 99:1100:12,20102:21 107:7121:18 122:4125:3 126:5,18127:19 128:9129:17 130:17139:22 147:19151:15 164:21181:10 182:16188:20 190:8197:15 199:6200:7 203:4210:2,22 256:14282:12284:15,19286:11,17
realm 124:12141:9
reason 21:6 23:1750:14 147:7189:10 262:11284:6
reasonably 240:2
reasons 164:12
169:15 249:9262:1 302:16305:14
reassessment 51:6286:16
recall 159:3
recalls 262:21
receive 167:11171:11 173:11204:7 206:10207:14
received 15:1021:2 89:11 141:5171:15
receives 29:2
receiving 26:17182:13281:11,15
recent 51:5 52:258:16 78:1180:21 137:20176:11 256:16262:17 294:20312:15
recently 67:16107:22 232:4250:12 267:12
receptive 184:13
receptor 117:9
Recess 106:2178:17 247:22
Reckeweg 152:15
recognition 89:18170:5
recognize 6:19
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starts 47:12 67:8
state 12:1613:9,11 36:1358:10 63:7 76:14132:2,3149:14,20166:14 212:5298:7
stated 94:14 207:6242:3 253:6
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statue 144:12
153:7,12
status 44:18 87:2289:15,17,19,2291:13 93:8,22135:18 200:2226:3
stay 115:20 155:12
steadily 262:16
step 70:18 71:1120:14,22194:19 200:14201:17 281:21
stepped 107:22
steps 57:6 192:22201:4 232:9
sterile 177:18
stick 317:21
sticking 179:3
sticklers 127:20
stimulated 118:22
stimulates 310:19
stimulation116:18 265:11
sting 98:15 274:17
stipulates 193:12
stocking 37:6
stop 144:16
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stopping 273:10
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streamlined 70:8
strength 194:15
strengthen 248:19
stress 182:16
stretch 248:4
strict 6:9 57:2138:18
strictly 13:1714:12
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strikes 141:5
strives 252:2
striving 164:16
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strongly 45:4274:1
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studies 41:2271:16 72:18,2073:1,2,4,7,2074:19 75:11,1276:2 77:12,18,2178:2,13,1480:3,9,14,15,1881:2 82:7 83:1785:10 118:4152:21 212:7232:13 251:17315:18 316:11
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sub 83:13
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subject 9:14 11:541:2 58:7 61:20222:10253:20,22 291:4
submission 292:14
submit 14:22159:10 253:11
submitted 28:2044:18 60:9
suboptimal189:12
subsequent 74:12
subsequently65:6,14
subset 83:18
substance 24:6,1627:5 28:22 30:1232:12 38:1147:3,6,7 49:4,1592:20 213:17,18
284:8 310:15,16
substances 20:1427:8 39:19 48:22140:5 168:15243:18 303:3
substantial 53:11138:16,20141:17 246:10293:4
substituting214:5,13
subtle 190:3
success 90:4132:22 208:6237:3 302:4305:16
successful 55:1288:5 224:20253:17 305:18
succession 103:11
succinct 181:18
suffer 114:17
suffered 25:3
suffering 191:16198:9,13 211:21
suffice 51:19
sufficient 113:9152:10 198:20199:1
suffocated 175:4
sugar 176:15271:8
sugars 54:16
suggest 57:5 243:2279:21
suggested 275:9277:5 292:12
suggesting 62:12
106:12 117:12222:2 297:21299:10
suggestion94:18,19
suggests 42:18
suicide 24:6
suit 206:20
summarize 63:3246:12 270:20
summary 26:2059:2 202:19254:8
super 105:8
superior 67:2
supermarket 37:9
supervisor 147:16148:15 149:1
supplement 47:493:3,8 231:13235:12
supplemental276:12,13,21,22
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supply 101:10,15
support 40:1052:22 56:15 79:791:10 108:21141:18 225:8,13227:18 244:8259:1 261:19
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suppress 39:12
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surprising 150:20283:16
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225:18
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surveyed 229:10250:20 289:20
surveys 191:21232:13 240:14
Survival 108:1
survive 175:5
survived 55:21
suspect 240:18
sustained 33:19
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sweet 304:8
swift 225:10
swiftly 255:4
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switch 119:21243:20
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symptom 161:5162:3 166:15273:17 289:21304:22 305:5308:1
symptomatic183:3
symptoms 37:7
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sync 121:9
synchronize 178:9
synonymous221:17
synthetic 118:19
system 19:3,1921:11 27:19 59:886:3,4 136:4138:15 140:10145:17146:10,14187:13 236:7253:10 287:12291:22
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136:6,16 222:8
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taking 30:11 92:18126:10 129:14148:17 180:4213:13 215:21262:10 263:13
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teacher 181:14
teacher's 128:21
teaching 67:7115:13
team 16:9 17:894:20 95:5,6164:16 238:4240:9
teams 66:2
tease 188:13
teasing 188:16
tech 17:15
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technically 312:22
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tenants 125:10213:16
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tents 106:13,16
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term 175:11211:17 215:22221:16 245:4270:5 274:11305:9 312:14
terminate 175:8
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terms 32:20 43:1670:19 71:3 87:694:18 101:11109:12 123:22128:18 131:10169:20 181:11182:20 184:10185:17186:2,17,21197:18 199:15203:1 209:22
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tested 34:16 57:2161:15 152:13
testified 176:2
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testimony 7:750:16 176:9319:4,6,9
testing 57:6 58:761:11 62:12202:2,6 247:7,8
tests 57:16 61:1762:4 108:16,17238:18 282:15
text 163:4
textbook 162:16
textbooks 142:7
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therapists 287:19
therapist's 128:22
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Thirty 137:2
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thoroughly 52:5291:10
thoughts 170:14197:2
thousand 26:21
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training 89:10,12110:2 111:5133:7 293:18311:14
tramadone 273:22
transcript 320:6,8
transcription320:1,9
Transcriptionist320:14
transfer 187:4
transferred 124:2
translated 67:18
translation 270:6
transparency285:20
transparently286:12
transport 64:21304:6
travelled 12:1
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treatable 191:17194:5 195:5200:10 254:12
treated 26:4 27:1055:7 56:4 99:5114:19 120:5,18174:4 175:9274:12 278:12
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trials 41:18,2069:19 71:17,1882:2,3 83:2286:18 196:22212:7 232:11277:18 279:1
tried 72:13 83:11145:5 186:5251:9 254:18256:20 282:20
trim 74:2
trio 218:11
triple 149:9
trivia 153:6
trivial 43:5
trot 111:15
trouble 133:11
troubled 240:16
true 56:16 57:2083:7 89:16 217:4273:4,18 277:20278:10 319:8320:9
truly 133:3 189:18313:14
trust 125:18148:22 263:2
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turned 119:4
turning 87:4,5223:18
turns 106:8
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twice 24:18
two-step 192:19
two-way 221:6
type 12:4 25:526:8 29:17 62:1263:21 66:9162:14 179:16187:12 238:22255:20 295:19296:13 307:22
typed 320:6
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types 64:1068:18,19 69:772:6 133:15167:6 228:1257:16 264:8
typewriting 319:7
typically 9:5 60:16
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ulcerative 55:17
ultimate 26:4
ultimately 21:822:16 280:5
um 29:20 125:6215:16 257:17
UMASS 116:10117:21
unable 303:15
unavailable 303:6
unaware 37:1558:3
uncertainty239:13
unclear 124:7
undergo 41:1
undergoing 89:12
undergone 40:1745:7
undergraduate118:18
underneath 79:6157:14
underpinned293:17
underscores 220:2
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unlikely 38:10251:19
unnecessarily149:1
unorthodox 68:6,7
unpacking 190:1
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unsafe 39:21
unsealed 148:22
unspecific 285:22
unsupported 59:2
untreated 211:12
upcoming 252:8
update 11:10161:7
updated 76:18,19
updating 176:4
upholding 168:12
uploaded 19:18
upon 13:2 59:474:18 84:4 89:12127:12 134:16149:21 275:18310:5
upper 263:5,6
upwards 53:15
urge 57:14 58:9,20115:2
urged 119:10
urges 235:8
usage 249:9292:21 313:5314:10
useful 39:7 169:10183:19 185:4304:8 310:9
usefulness 65:17
users 251:12
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usual 39:21 81:8279:19
usually 33:19 82:9186:22 267:1304:1
uterus 174:14
utilization 291:15
utilized 136:3,13289:16 292:15
Vvacation 136:1
validate 200:22247:4
validated 247:11
validity68:17,19,2069:1,3,7
valuable 95:17241:19
value 254:10
variability 48:2149:1,3 112:17122:14 249:16
varies 53:5 84:3103:10 271:3
variety 63:1668:18 76:22139:15 155:13204:2 206:3243:15
various 10:9 130:6190:6 211:12212:18,20235:22
vary 249:15
varying 103:17
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victims 22:14
view 150:22 285:2
viewed 231:19
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viewpoint 313:19
vigilant 295:4
vigorous 89:10
violate 147:3
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virtue 270:2279:13
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vision 314:11
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