FDA ConsumerThe Magazine of the U.S. Food and Drug Administration

March-Apri l2000 • Vol.34 No.2

Medical Milestones Of The Last Millenniu

Donna E. Shalola, Ph.D.Secretory of Heal andHumon Services

Jane E. Henney, M.D.CotTmiissioner of Food and Drugs

Lawrence Bnchorik, Ph.D.Interim Associate Commissioner for Public Affoirs

Isodorn Stehlin /Editor

Patricia N. Edwards / Art Director

Michael I. Herndon / Production Monoger

Carol I. Ballentine / Copy Editor

Cover courtesy of the Library, University of Bologna,through the Notional Library of Medicine, Bethesda,Maryland. This scene depicts a 15th century open-oirpharmacy.

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FM Comum (ISSN 00362-1332) is published bimonthly by theFood ond Drug Administration (HFI-40), 5600 Fishere Lane,Rockvllle, MD 20857, U.S. Public Health Service, Department ofHeoltb and Human Services.

Editorial Matters

Address for editoriol matters is FDi Consumer, Food and DrugAdministration (HFI-40), 5600 Flshere Lane, Rockville, MD 20857.Atticles in FM Consumer maf be tepublished without permission.Credit to FM Consumer as the souice is oppreciated. FDA Consumeris indexed in the Reader's Guide to Fenodicat Literature. The currentFDA Consumer Index IS available on FDA's Website at

wm.fda.gov/fdac/index/mnindex.litm.

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•4 Inside Front Cover Photo:

WkConsumerThe Magazlneof ttie U.S. Foocj ancJ Drug Administration

March-Apr i l 2000 • Vol . 34 No.2

M e d i c a l M i l e s t o n e s o f t h e L o s t M i l l e n n i u m 8Take o look bock to see how for the art of healing has progressecd from the dayswhen barbers often did double duty as surgeons and raging epidemics killedhuge segments of the population.

T h e D e a t h o f t h e P a r t y 1 4Young thrill seekers take GHB for an easy high. But what's really easy to get fromthe drug is an accidental overdose resulting in seizures, coma, or even death.

Tampon Safety: TSS Now Rare, But Women Still Should Take Care 20Though tampons were linked in 1980 to more than 800 cases of potentiallydeadly toxic shock syndrome, the suspect tampons were removed from the marketand TSS cases dropped drastically. But women still need to be vigilant and takesome basic care steps.

Your Medicine Cabinet Needs an Annual Checkup, Too 25Ever wonder what items should be in a well-stocked medicine cabinet? Contraryto the name, medicine isn't one of them. Check out FDA's list of cabinet must-haves(and must-nots).

Science at FDA: The Key to Making the Right Decisions 29FDA's scientific expertise is more important than ever as the agency sets policy andenforces lows in increasingly complex arenas such as molecular biology, nuclearphysics, and electrical engineering.

U p d a t e s 2

f d a . g o v 3 4

I n v e s t i g a t o r s ' R e p o r t s 3 5

Summar ies o f Cour t Ac t i ons 36

/ ; RUBBINi ALCOHd

FDA optical engineer Robert Faaiond monitors the agency's 1.5-watt Argon laser used to testand calibrate devices ranging from laser pointers to radiant scalpels. For more on FDA science,see page 29.

FDA Consumer / March-April 2000 / 1

Updates

Breast Cancer Drug Takes AimAt Advanced Lung Cancer

A drug previously approved to treatadvanced breast cancer has receivedadditional FDA approval for treatingnon-small cell lung cancer that does notrespond to chemotherapy with cisplatindrugs.

Taxotere (docetaxel) may be used totreat non-small cell lung cancer that islocally advanced or has spread to otherorgans. Typically, this type of cancer,when diagnosed, has spread beyond thelungs and cannot be cured. But two recent clinical trials showed that patientstreated with Taxotere had increased survival rates compared with those who received other treatments, such as thecisplatin-based drugs Navelbine(vinorelbine) or Ifex (ifosfamide).

Taxotere is made by Rhone-PoulencRorer, Collegeville, Pa.

Use Original MammogramsFor Image Comparisons

Women should get their originalmammograms rather than copies, whichare considered inferior, says FDA, whenthey need them for comparison withother mammograms or for follow-upclinical procedures. Facilities are required to transfer the original films under the Mammography Quality Standards Act (MQSA) final regulations,which became effective April 28, 1999.FDA also reminds women that fac i l i t ies

may not charge patients for copyingtheir original mammograms, unless thepatient requests copies or copies must bekept at the facility under state regulations. (For more information, see "FDASets Higher Standards for Mammography" in the January-February 1999 issueof FDA Consumer.)

Drug-Device Combo OK'd for Precancerous Skin LesionsTo treat certain skin lesions that may lead to skin cancer if left untreated, FDA

has approved a first-of-its-kind combined drug-device treatment.Levulan Kerastick (aminolevulinic acid HCl) was approved to treat precancerous

skin lesions called "actinic keratoses" (AK) on a patient's face and scalp.In a two-stage treatment process, a doctor first topically applies aminolevulinic

acid directly onto the individual AK lesions, then follows up 14 to 18 hours laterwith a special blue light.

AKs are rough, scaly red or brown patches on the skin that are found mostly onlight-complected individuals, including over 50 percent of elderly fair-skinnedpeople living in hot, sunny climates.

Approved Dec. 6, 1999, the Levulan Kerastick was designed to treat individuallesions, thereby reducing possible skin irritation of unaffected skin. It has not beenapproved for the treatment of AKs on the back or arms.

Other treatments for AKs include freezing or scraping the skin, electrosurgery,excision, laser surgery, and topicalchemotherapy.

But the best method for combatingskin cancer is still prevention, say medicalexperts. Commonsense measures such aswearing protective clothing, avoiding themidday sun, and wearing sunscreen with asun protection factor (SPF) of at least 15are still the best defenses.

The Levulan Kerastick, made byDUSA Pharmaceuticals Inc. of Valhalla,N.Y., will be marketed in combinationwith the light source BLU-U Blue LightPhotodynamic Therapy Illuminator.

Government urges safer needles ... Toprotect thousands of workers from dangerous infections received when theyaccidentally prick themselves with aused needle, federal health officials recommended last November that hospitalsand other health-care facil it ies use saferneedles and syringes. The national Centers for Disease Control and Prevention

says that some 600,000 to 800,000health workers accidentally stick them

selves each year, increasing their risk forinfections such as hepatitis and HIV. Therecommendations are voluntary and areintended to provide guidance for employers and workers. FDA has approvedthe sale of 50 types of specially protected needles and syringes, but theAmerican Nurses Association says thatonly 15 percent of hospitals are usingt h e m .

AIDS no longer a leading killer ... AIDS deaths have dropped to the lowest levelsince 1987, moving the disease off the list of the 15 leading causes of death in theUnited States. According to the National Center for Health Statistics, the age-ad-justed death rate linked to infection with the AIDS virus, dropped 21 percent to 4.6per 100,000 persons in 1998, following a 48 percent decline from 1996 to 1997.

2 /March-April 2000 / FDA Consumer

New Rule Expands Allowable Dietary Supplement ClaimsA final FDA rule defines statements now allowed on dietary supplements, ex

pands the number of acceptable product claims, and explains how FDA will distinguish allowable "structure/function" claims from disease claims.

The rule should help consumers choose appropriate dietary supplements without affecting the availability of these types of products.

Under the Dietary Supplement Flealth and Education Act of 1994, dietarysupplements may, without prior FDA review, carry claims about the product's effect on the structure or function of the body. Prior agency review is necessary,however, for claims that a product can prevent, treat, cure, mitigate, or diagnosedisease.

The final rule prohibits unreviewed disease claims that are either express, suchas "prevents osteoporosis," or implied, such as "prevents bone fragility in postmenopausal women." Also, the rule clarifies that unreviewed disease claims arenot allowed in the name of a product ("Carpaltum"), in a statement about theproduct's formulation ("contains aspirin"), or through the use of pictures, vignettes, or symbols (electrocardiogram tracings).

The new rule permits claims that do not relate to disease. Such claims includehealth maintenance claims ("maintains a healthy circulatory system"), claims forcommon, minor symptoms associated with life stages ("for common symptoms ofPMS," "for hot flashes"), and other nondisease claims ("for muscle enhancement," "helps you relax").

The rule permits structure/function claims about certain common conditionsassociated with aging, menopause and adolescence. However, osteoporosis andother serious conditions associated with aging, menopause or adolescence willstill be treated as diseases.

Although the rule, which went into effect 30 days after its Jan. 6 publication,allowed for structure/function claims associated with pregnancy, FDA announcedon Feb. 9 that it would review concerns recently raised about this issue. Until thereview is complete, the agency advises dietary supplement manufacturers not tomake any claims related to pregnancy on their products based on the Jan. 6 finalrule. As always, FDA urges all pregnant women to consult their health-care providers before taking any dietary supplements or medication.

Risky 'Weight Loss' ProductPrompts Warning from FDA

FDA is warning consumers not to buyor use a product sold for weight lossbecause it could cause serious health

problems.The product, Triax Metabolic Accelera

tor, contains a potent thyroid hormone thatcould cause heart attacks, strokes, andother serious health effects. It has beenmarketed in retail stores and on theInternet as a dietary supplement, but FDAconsiders it an unapproved drug.

Through its MedWatch reporting system, FDA learned of several people whohad abnormal thyroid function test results while using Triax. These individuals sought medical attention because ofsymptoms such as severe diarrhea,fatigue, drowsiness, and extreme loss ofweight after using the product.

The active ingredient in Triax Metabolic Accelerator is triiodothyroaceticacid (TRIAC). FDA urges consumers tostop using any product containing thatingredient and to seek medical attentionif they experience insomnia, nervousness, sweating, or diarrhea.

Syntrax Innovations Inc., CapeGirardeau, Mo., marketed Triax Metabo l i c Acce le ra to r. M issour i o f fic ia l s em

bargoed the product, preventing sale ofthe company's on-hand supply. Theproduct's manufacturer, Pharmatech,Linden, Utah, agreed to stop distributingany product containing TRIAC.

Women still falling short on folic acid ... Although the federal government announcedseven years ago that a type of birth defect is linked to a lack of folic acid, public health officials say that these birth defects are still occurring. According to the March of Dimes, asmany as 2,000 to 2,800 cases of neural tube birth defects (out of an estimated 4,000 peryear) could be avoided in the United States if women of reproductive age consumedenough folic acid. FDA last year mandated that cereal and grain products be fortified withfolic acid, but the fortification level was kept low (about 1,000 micrograms per day) because of a fear that too much folate can cause a dangerous blood disease, or can mask a vitamin Bi2 deficiency.

FDA Consumer / March-April 2000 / 3

M Updates (continued)

New Epilepsy Drug Works Well Combined with OthersWith the approval of a new drug for epilepsy that can be safely combined with

other anti-epilepsy medicines, adults with partial onset seizures—those that affectonly one area of the brain—may soon be able to better control the disorder.

Epilepsy affects some 2 million people in the United States, causing them to haveseizures with symptoms ranging from shaking of a single arm to loss of consciousness and generalized spasms. Brief disturbances in the brain's electrical activity occur when the nerves in the brain fire spontaneously, causing the seizures.

FDA approved the new therapy, Keppra (levetiracetam) in December after threemulticenter clinical studies involving some 900 patients demonstrated the drug's effectiveness as an adjunct therapy. Because it is not metabolized through the liver, asare most of the two dozen or so other antiepileptics, it is unlikely to cause interactions with the other epilepsy drugs or other commonly used prescription medications, such as oral contraceptives.

In clinical studies of Keppra in more than 1,300 epileptic patients, no seriousblood or liver-related toxicities were seen. The drug may, however, cause dizzinessand sleepiness. The new drug will be manufactured and distributed by UCB PharmaInc. of Smyrna, Ga.

Combination Anti-Stroke Drug May Be Better Protection for SomeA new drug that combines two anti-stroke treatments has been approved by FDA

after studies showed that it can reduce stroke risk for some patients more than either ingredient alone.

FDA approved Aggrenox—^which combines aspirin and dipyridamole—to reduce stroke risk in those who have already had a transient ischemic attack ("mini-stroke") or an ischemic stroke. Each year, 400,000 Americans suffer ischemicstrokes, caused when a blood clot reduces or blocks blood flow to the brain.

In the two-year "European Stroke Prevention Study 2," which included morethan 6,000 patients who had recently showed ischemic stroke-related symptoms,the combination drug reduced stroke risk by about 37 percent and the risk of strokeand death by about 24 percent, compared with a placebo.

Side effects linked to Aggrenox include headache, abdominal pain, dizziness,and nausea. Patients who are hypersensitive to any of the drug's ingredients shouldnot take the drug.

Aggrenox, approved by FDA last November, is marketed by BoehringerIngelheim Pharmaceuticals Inc., Ridgefield, Conn.

Meat irradiation can boost food safety ... The U.S. Department of Agriculture, which regulates the meat industry,now allows refrigerated or frozen raw meat and meat products, such as ground beef, steaks, and pork chops, to be exposed to high levels of radiant energy. This irradiation process can eliminate or greatly reduce deadly E. coli bacteriaand other hazardous microorganisms in raw meat. Irradiatedmeat and meat products must bear the international symbolfor irradiation, the radura, along with a statement of its use.FDA approved irradiation of red meat in 1997.

Keep on walking ... Women who walkbriskly for at least three hours a weekcould cut their heart attack risk by 30 to40 percent, says a long-term study of72,000 women aged 40 to 65. Briskwalking for five hours or more a weekcut heart attack risk by more than 40percent. And those who added another90 minutes a week doing vigorous exercise, such as aerobics, cut their risk almost in half. Even women who had been

sedentary most of their lives began tobenefit when they started exercising, andas little as an hour a week of brisk walk

ing helped reduce heart attack risk. Several studies have shown that the findingsapply equally to men. (New EnglandJournal of Medicine, August 1999)

Smoking cessation aids show similarresults ... In one of the first studies to

assess the effectiveness and ease of useof common nicotine replacement products, researchers at the Royal LondonSchool of Medicine and Dentistry foundno significant differences in abstinence,cravings or withdrawal symptomsamong 504 smokers. Participants, allover age 18, smoked an average of half apack a day, were in good health, and hadnot tried to quit in the previous threemonths by using a nicotine replacementproduct. They used nicotine gum, thepatch, a new nasal spray, and an inhalerin the study. Smokers were most likelyto use the patch at its recommendeddose. Some used the gum, inhaler orspray more sparingly than was recommended, possibly to save money. At theend of the 12-week period, about one infive people in each group had managedto stay off cigarettes. (Archives ofInternal Medicine, September 1999)

4 /March-April 2000 / FDA Consumer

First Post-Traumatic Stress Disorder Treatment ApprovedA drug previously OK'd by FDA for treating depression, obsessive-compulsive

disorder, and panic disorder has now become the first drug approved to help thosesuffering from another psychiatric condition: post-traumatic stress disorder (PTSD).

Two studies showed Zoloft (sertraline hydrochloride) to be effective in treatingadults diagnosed with PTSD, a condition marked by re-experiencing a traumaticevent that evoked feelings of intense fear, helplessness, or horror.

People with PTSD can relive the traumatic event in flashbacks or dreams, according to the American Psychiatric Association, and may experience symptomssuch as irritability and angry outbursts, sleep disturbance, impaired concentration,and loss of interest in significant activities. A PTSD diagnosis requires that thesymptoms last at least a month and significantly interfere with one's social life,work, or other activities.

In the two multicenter studies of Zoloft, women as a group seemed to benefitmost from Zoloft, with little effect seen in men. Scientists don't know why thisapparent gender difference exists.

Common side effects of Zoloft include dry mouth, stomach upset, and sleepin e s s .

The drug, marketed by Pfizer Inc., New York, was approved for PTSD lastDecember after an FDA advisory committee recommended its approval.

Life extended by kidney transplants ...People who receive kidney transplantslive an average of 10 years longer thanthose who continue on dialysis, says astudy by the University of Michigan etal. The study also showed that transplantpatients have a better quality of life byavoiding dialysis. Of the 43,584 peoplein the United States currently on thewaiting list for kidney transplants, theUnited Network for Organ Sharing reported that 12,166 received operationslast year. (New England Journal ofMedicine, December 1999)

Po ss i b l e l i n k i n A l zh e i me r ' s . . . An

enzyme thought to play a role in the formation of beta-amyloid, a protein associated with Alzheimer's disease, mayhave been isolated by California researchers, says a new study. Researchersat Amgen Inc. report that they found anenzyme called beta-secretase that isthought to start the process that leads tothe formation of beta-amyloid, whichcollects in the brains of Alzheimer's patients and kills neurons, the central feature in the disease process. Researchersbelieve that identifying the correct enzyme could lead to drugs that wouldblock beta-amyloid formation.Alzheimer's disease is a deadly disorderthat gradually destroys the brain, causing slow loss of memory and the abilityto reason. (Science, October 1999)

Serious Product Problem? Report ItHealth professionals can report serious adverse reactions or other product problems toFDA's MedWatch program by:• Mail: Use the postage-paid MedWatch form• Phone: 1-800-FDA-1088 (1-800-332-1088)• Fax: 1-800-FDA-0178 (1-800-332-0178)• Internet: www.fda.gov/medwatch/

Call the 800 number or visit the Website for forms or for further assistance.FDA encourages consumers to report through their doctors, but if they prefer, they

may submit the MedWatch form themselves.

FDA Consumer / Morch-April 2000 / 5

Updates (continued)

Rare Genet ic DisorderTreatable with Arthritis Drug

A prescription arthritis drug is nowalso approved for treating a much lesscommon disorder that can greatly increase young people's risk of colon andrectal cancer.

Celebrex (celecoxib), which is in aclass of drugs called COX-2 selectivenonsteroidal anti-inflammatory drugs,can help reduce the number of colorectalpolyps in those with the rare genetic disorder "familial adenomatous polyposis"(FAF). It has been approved since 1998to treat the symptoms of osteo- andrheumato id a r th r i t i s .

To treat the genetic disorder, Celebrexshould be used with other therapies—typically, surgical removal of all ormuch of the lower intestine (colon andrectum) by early adulthood and carefulmonitoring of any remaining lower int e s t i n a l t i s s u e .

The December 1999 approval ofCelebrex for the potentially life-threatening FA? was an accelerated approvalbased on the drug's ability to reduce thenumber of colorectal polyps. In a six-month study of Celebrex in 83 patients,sponsored in part by the National CancerInstitute, patients receiving the drug experienced a 28 percent reduction in thenumber of polyps, compared with a 5percent reduction in those getting a placebo. The most common side effectswere diarrhea and indigestion.

Because the ul t imate benefit to FA?

patients of reducing colorectal polyps isnot known, FDA is requiring the manufacturer, G.D. Searle & Co., Chicago, toconduct further studies to determine the

drug's clinical value, as well as to establish whether the effect of Celebrex wi l lcontinue after patients stop taking thedrug.

'Nail Polish' Is First to Treat Finger and Toe FungusThe first topical solution approved by FDA for treating fingernail and toenail fun

gus may offer relief to Americans sufferingfrom these sometimes painful types of infect i o n s .

Penlac Nail Lacquer (ciclopirox) TopicalSolution 8% is a synthetic antifungal agentthat inhibits the growth of dermatophytes, atype of fungus that grows on the skin, hairand nails. Infected nails can become white,thick and brittle and can cause people painwhen they walk or do other simple activities.

Penlac is applied to all affected nails andadjacent skin once a day with an applicator brush over the previous coat, and removed every seven days. Treatment consists of up to 48 weeks of daily applications,weekly trimmings by the patient, and monthly professional removal of the unattached, infected nail.

While approved just last December to provide topical therapy for nail fungus,Penlac's active ingredient has been marketed for other uses worldwide for 25 years,and in the United States since 1982.

The nail lacquer is manufactured by Aventis Pharma Deutschland GmbH, Frankfurt, Germany.

Is internal cleansing healthful? ... Using a product that's too strong for yourdigestive tract could cause several days'worth of diarrhea—with nausea, stomach cramps, and vomiting—FDA warns.Internal "cleansers" such as teas, powders, herbal capsules, and fiber pillsclaim to increase the body's performance by ridding the system of environmental toxins, unfriendly bacteria, orcrusted food waste that has lingered toolong in the intestine. But doctors at the

Human Nutr i t ion Research Center a tTufts University say that gastrointestinaltract cells turn over every three days,which is not enough time for food crusting to take place. The body also has itsown avenue of defense against such toxins, and the liver works nonstop to neutralize potentially harmful compounds.FDA has received several reports of serious adverse events associated with usingsuch cleansers.

Back pain treatments similar ... Conventional medicine appears to work about aswell as spinal manipulation at treating lingering back pain, says a three-monthstudy by doctors and osteopaths at the RushPresbyterian-St. Luke's Medical Center in Chicago. Other studies have shown that many backaches go away within a month, regardless of thetreatment. The new study involved patients whohad been in pain for at least three weeks but lessthan six months. There was no difference in howthe two groups felt at the end of three months,and pain had decreased by half in both. (NewEngland Journal of Medicine, November 1999)

6 /March-April 2000 / FDA Consumer

what's the Track Record of Implanted Devices? NIH Conference Focuses on Realities, ExpectationsFor more than 40 years, physicians

have implanted medical devices inpeople to save lives, restore function, orenhance the human form. Experts estimate that 8 to 10 percent of all Americans, some 20 million to 25 millionpeople, carry some form of implanteddevice, from complex machines like acomputerized heart pacemaker to structural supports such as an artificial jointto something as simple as the sliver ofplastic used to repair cataracts.

Yet, little information is availableabout the long-term safety and effectiveness of many implanted devices becauseno one—not the Food and Drug Administration, not the manufacturers, nor anyother organization—tracks an implantfrom cradle to grave. While estimatescan be made about the useful lifespan ofsome devices, the longevity or failurerate of many others is unknown. To startthe search for a solution, the National Institutes of Health hosted the TechnologyAssessment Conference on ImprovingMedical Implant Performance ThroughRetrieval Information in January.

"The idea of the conference is that if

you can learn about the devices, howthey age—how they wear, all the thingsthat can happen to a device—then youcan improve the next generation of devices," says David W. Feigal Jr., M.D.,director of FDA's Center for Devicesand Radiological Health. The only wayto gather that kind of information is tosystematically retrieve and analyzemedical devices after they have stoppedfunctioning, either because of failure orpatient death.

NIH's panel of independent experts,co-chaired by former Assistant Secretaryof Health Edward N. Brandt Jr., M.D.,and Julia R. Weertman, an engineer fromNorthwestern University, sifted throughthe available data to identify the impediments to collecting this kind of information. They discovered that significant

barriers include the costs associated withretrieval and "the fear of litigation affecting manufacturers, hospitals, physicians, and investigators."

Cost is a substantial problem. Insurance companies pay to have medical devices implanted to improve a patient'shealth, but do not pay to remove them,especially if the patient has died. Thereis l i t t le incent ive for medical devicemanufacturers to pick up the tab, eventhough the research would benefit them.

"We re-proposed that NIH fund a series of centers that would collect specimens of medical devices" that had beenremoved from patients, Feigal says. Theretrieved devices would then be ana

lyzed to determine what made them afailure or a success. For example, a patient might walk on a hip implant for 25years but die of a heart attack. The implant would be considered a success, anddevice designers would like to knowwhy it worked so well.

Even if the funding became available,legal concerns still get in the way. "TheAmerican public accepts the failure ofbiological implants," says Brandt. "Atransplanted heart or liver doesn't work.That's unfortunate but those things happen. But the public never seems to thinkthat a mechanical dev ice—an ar t i f ic ia l

hip or pacemaker—is going to wear out,though they have plenty of experience ofthat with their household appliances andautomobiles. They tend to think that it isa mechanical thing, and it is going to beO K . "

So when an implanted device fails, thesearch for the guilty begins. Concernabout litigation prevents physicians, hospitals and manufacturers from evengathering information on a failed or removed medical device because they fearthe information might be used againstthem in court . The committee recommended that FDA and NIH sponsor asecond "conference on the relationship

between (and possible adverse effectsof) litigation and medical innovation."

The risk of litigation may be increasedby the fact that "patient expectations ofthe benefits of medical implants are often unduly high," the committee concluded. This occurs, in part, because "information presented to the patients maybe poorly understood, misleading or inadequate." The committee recommendedthat FDA and NIH develop a multifac-eted education campaign to provide realistic information about implanted devices and the need for retrieval. The

campaign would include a Websitelinked to existing databases for devicesand provide background information toconsumers about implants and informedconsent, and even provide patients witha card that describes the device theycarry in their body. The card also couldserve as an implant "donor" consentform, analogous to an organ donor card,to simplify postmortem retrieval.

"There are some unique opportunitiesfor us to learn more, especially whenyou have the ability to look at a problemacross manufacturers," Feigal says," w h i c h F D A c a n d o . "

FDA Consumer / March-April 2000 / 7

WebtcafWifestones o'by Carol Lewis

The histOty of fnedicine has never been a particularlyattractive subject in medical education and one reason for this is thatit is so unbelievably deplorable ... bleeding, purging, cupping and theadministration of infusions of every known plant, solutions of everyknown metal, every conceivable diet including total fasting, most ofthem based on the weirdest imaginings about the cause of disease,

concocted out of nothing but thin air—this was the heritage ofmedicine until a little over a century ago.

- ^ e w i s T h o m a s

American physician1 9 1 3 - 1 9 9 3

A young boy chants rhythmically over a medallion hangingfrom his neck to ward off sickness. A man gets a haircut and acyst removed—both by his barber. Roses and mustardpounded together and mixed with purified oil—a small portionplaced on the tongue, the remainder blown through the nostrils—soothes a chronic cough and controls wheezing.

It matters not that the boy may be an Indian, the man a medieval prince, or that there was no scientific approach to this11th century cure for bronchitis. Every culture has its folkloreabout health and medicine, whether material or magical, depending on the particular stage of human evolution.

Historians say it seems probable that as soon as humanswere able to reason, they discovered by trial and error whichplants might be used as foods, which of them were poisonous,and which had some medicinal value. People found herbalremedies to deal with common discomforts, such as colds orconstipation. In fact, almost all the laxatives that appear on ourpharmacists' shelves today, according to John M. Riddle,alumni distinguished professor of history at North Carolina

State University, were used by ancient societies. And it wasdiscovered thousands of years ago that willow bark, whichcontains salicin, a substance related to the salicylates used tomake aspirin, relieves pain.

Primitive physicians showed their wisdom by treating thewhole person—soul as well as body. At times, treatments andmedicines that produced no physical effects, nevertheless,could make a patient feel better. Ironically, this so-called"placebo effect" remains applicable even in clinical medicinetoday. (See "The Healing Power of Placebos," January-February 2000 FDA Consumer.)

Other cultures made medicines from parts of animals andminerals, which were especially favored as antiseptics. Selecting the appropriate remedy was often guided by either theprinciple of "opposites" or "similars." For example, if theroasted brains of a fearful rabbit failed to cure excessive timid

ity, courage might be found in the blood of a ferocious animal.But while ancient Egyptian medical treatments were said to include ox spleen, pig's brain, and tortoise gall, historians be-

8 /March-April 2000 / FDA Consumer

t e ost ' tfcnium

The doctor

making a housecoll in the early1900s had verylittle available to

treat this family'sflu symptoms.(Source: FDA

History Office)

lieve that "ass's heads" and "pig's teeth" may have been nomore what they seemed than are "buttercups" cups of butter or"foxgloves" gloves worn by foxes.

Accounts of miraculous healing indicate that saints andtheir relics stood alongside home remedies and local medicalpractitioners to treat the ill. Sometimes prayer and anointingwith oil in the name of the Lord was the extent of treatment.

Diet, baths and exercises all have played their part in treatingillness, as well as drinkable gold and "temple sleep." Attemptsby the Chinese to understand a complex world by simple principles led to the notions of yin and yang—two complementarylife forces considered to be balanced in health but disturbed ins i c k n e s s .

Because early civilizations had a high rate of infant deathand an even higher rate of illness, life expectancy wasappallingly short. Many of today's common cancers rarely occurred simply because most people didn't live long enough forthe diseases to emerge. And the gnarled hands and painfuljoints associated with old age were not thought of as a disease

but as the natural condition of those who were blessed to havesurvived the major epidemics of their times.

Magic and Faith (A.D. 1000 to 1492)The medical system of the early part of the millennium

lacked experts trained in healing, as well as specialized medical institutions, because the institutions that trained or employed practitioners—the monasteries or courts—were not exclusively or even primarily medically knowledgeablethemselves. Virtually anyone could be a healer. There was nolicensing, and some patients drew on the services of practitioners holding radically different and contradictory beliefs. Self-help was widespread, and often illness was treated at home.

Medicine was still dominated by the ideas of Galen, an ancient Greek physician whose theoretical principles were basedon notions that human functioning was composed of mixedand blended elements (fire, water, air, and earth) and humors(blood, phlegm, yellow bile, and black bile), each with particular qualities, and all vital for life.

FDA Consumer / March-April 2000 / 9

Every culture has its folklore about health and medicine.

When someone fell ill without obvious cause, especiallywith such symptoms as fits, vomiting, confused speech, or delirium, there were three possible explanations: disease, fraud,or demonic possession. Along with animal remedies—including blood, bile, bone, and even excrement—magic symbols,faith healing, and sacred amulets became widely used tocombat d isease.

Drugs used were very simple, and most were extractionsfrom plants such as thyme, dandelion, St. John's wort, lavender, and poppy. The entire plant or just roots, leaves, or seeds,were used in the preparation. No precise details have survivedas to quantities or weights of such preparations, but instructions such as "a handful, a bundle, a cup" were recorded, andwafers were the preferred dosage form.

In the midst of a belief in magical powers to afflict and toheal, events of medical enormity began raging in the form ofepidemics. Lice and ticks carried typhus and other diseases associated with poor hygiene. Bacteria, mold and other contaminants in spoiled foods could cause convulsions or gangrene.Poor diet resulted in scurvy and other deficiency diseases.

While it was unthinkable that invisible parasites, transported by fleas to rats and then to humans, could be responsible for ravaging whole populations, some did recognize thelink between hygiene and health.

"Thou must not put either thy fingers into thine ears, or thyhands to thy head," wrote Fra Bonvicino da Riva in 1290, atime when hands, not forks, were the utensils of choice. "Theman who is eating must not be cleaning by scraping with hisfingers at any foul part." Although Brother Bonvicino failed todefine "foul part" in his courtesy books, later less-inhibitedwriters instructed their readers not to blow their noses with

A urine flask was the trademark of the physician during the earlycenturies of the last millennium. In later years, urine-gazing toidentify the source of an illness became the mark of the quack.(Source: NIH National Library of Medicine)

l O O O sFirst school of medicine establ ished

in Salerno, Italy

Highlights In Medical History

1 2 0 0 sFirst str ict measures for control of

public hygiene instituted

1 3 0 0 sFirst dissection of human corpse

1 4 0 0 sFirst recorded regulations for mid-

w i v e s

1 5 0 0 sFirst scientific study of human anatomy

published

1 6 0 0 sBlood c i rcu la t ion fi rs t descr ibedBacter ia d iscovered

10 /March-April 2000 / FDA Consumer ILLUSTRATIONS BY JACK PARDUE

iVlany of today's common cancers rarely occurred in early civilizations simplybecause most people didn't live long enough for the diseases to emerge.

their fingers and not to scratch at that segment of the maleanatomy generally known as the "codware."

But a 14th century German writer later recommended, "If ithappens that you cannot help scratching, then courteously takea portion of your dress and scratch with that. That is more befitting than that your skin should become soiled." Thescratcher's dinner partner, as it happened, was not as concerned with smudges on the scratcher's face as he was withthe possibility of having a louse transferred back to the bowlfrom which he ate.

Surgery and a Shave (1492 to 1776)As the Renaissance emerged out of the Middle Ages, a new

scientific spirit developed. The next few centuries showed aneagerness for discovery and a desire to escape from the limitations of tradition and explore new fields of thought and action.Even so, a layer of superstition still remained.

The physician prescribed and the apothecary dispensed. Before the 18th century, doctors were rarely present at childbirth.This was left to midwives, who relied on folklore and tradition. Giving birth was not a private event—rather, it was along, drawn-out public ritual.

Lower in status than the "physician" was the surgeon. Hiswas a craft, not a science, involving the hand not the head.Dubbed "Mr. Sawbones," the surgeon was likened to abutcher—because of his direct association with cutting andbleeding—but lumped together with barbering because bothprofessions involved arts of the knife. Barber-surgeons hadtheir own books on abdominal injuries, anal fistulae, bladderstones, and cataracts, and their treatments involved primarilycauterizing (burning) and bloodletting, a means of ridding the

body of poisons by opening a vein. (Some critics of this technique believed that George Washington was bled to death inhis last illness on Friday, Dec. 13, 1799.)

Laws against dissecting human corpses also began to relaxduring the Renaissance. As a result, the first truly scientificstudies of the human body began. Surgery rose in quality (andsurgeons in status) by the 18th century, largely due to this newoutlook towards anatomy. The painful practice of cautery tostop bleeding, for example, was replaced by ligatures anddressings.

While the 18th century witnessed advances in medicine,more importantly, it began to transform perceptions ofmedicine's place in society.

Addiction and Antitoxin (1800 to 1900)The industrial revolution created conditions for an explo

sion in both population and illness, including some new diseases brought on by filth, such as tuberculosis. Injectableopioids, such as opium, morphine, heroin, and cocaine,

The U.S. Postal Service is

sued this stamp, showing alate 1 9th century medicinelabel, in February 1998 tocommemorate the Pure Food

and Drugs Act of 1 906.(Source: FDA History Office)

1 7 0 0 sFirst law requiring licensed medical

practitionersObstetrics established as a separate

branch of medic ine

Vaccination against smallpox developed (1796)

1 8 0 0 sFirst practical anesthetic, ether, intro

duced (1842)Diagnostic tools, such as microscope,

thermometer and x-rays, inventedGerm theory introduced (1879)Rabies vaccine discovered (1885)

FDA Consumer / March-April 2000 / 11

Since its introduction in 1899, aspirin has been the mostpopular drug of all time.

brought addiction along with pain relief. The old family doctors gave morphine at the drop of a hat, and tales are rampantof patients whom these physicians casually addicted.

Opioids were sold without restriction, and labels on bottlesof elixirs and 'snake oil' gave no hint of addictive ingredients.At the same time, harmless and almost always useless preparations were touted for the cure of every disease and symptom.Tor example, typical products claimed to "renovate" the stomach, liver and kidneys, and to cure diabetes, gallstones, andweak hearts. According to the 1859 Family Medical Almanac,one medicine that was hailed as a cure-all for as many as eightdifferent illnesses in fact hurried thousands to a prematuregrave. Without lists of ingredients and warnings against misuse, what little information the public received came mostlyfrom bitter experience.

Federal controls over the drug supply didn't begin until1848, when Congress required the U.S. Customs Service tostop entry of adulterated drugs from overseas.

A sensation occurred in the late 19th century when an antitoxin for diphtheria was developed from the blood serum ofanimals injected with diphtheria toxin. Its introduction sharplyupgraded the doctor's image in the eyes of the public, becausefor the first time medicine was truly capable of curing an infectious disease that threatened the children of every home inthe nation.

Aspirin and Vaccines (1900 to 2000)Emil Corwin was one such child. Though his memory of

suffering from diphtheria in 1910 as a boy of about 7 is scantyat best, the now 96-year-old public affairs specialist, who re- Emil Corwin reflects on some medical milestones in his childhood.

1900sMajor blood types (0, A, B, and AB)

i d e n t i fi e d

First antibiotic drug, penicillin, discovered (1928)

First successful polio vaccine (1950s)Birth control pill introduced (1960)First successful heart transplant

(1967)First test-tube baby born (1978)AIDS first recognized by the Centers

for Disease Control and Prevent ion

(1981) {The first AIDS-like caseswere identified more than a centuryearlier, in 1872)

Scientists clone sheep (1997)

Highlights In Medical History

1 2 /March-April 2000 / FDA Consumer

Federal controls over the drug supply didn't begin until 1848, when Congressrequired the U.S. Customs Service to stop entry of adulterated drugs fromo v e r s e a s .

tired at the end of 1999 after nearly 30 years with the Food andDrug Administration, is grateful to have survived the horrorsof a once-raging epidemic.

"Lucky for me they had a vaccine when I got diphtheria,"Corwin reflects. "The number of deaths from this and otherepidemics, including the flu, was evident by the wreaths hanging on our neighbors' doors, and most of them had one." Ofthat experience, Corwin remembers only how sick he was atthe time, and the image of his doctor arriving at the house byhorse and buggy to administer his shot.

Corwin also remembers the relief stations that predated hospitals, a time when balanced diets were of no concern, andpharmacies of long ago, when "the guy behind the counter wouldcome around to the other side and take something from your eye,if you had a problem." The pharmacist, he says, thought nothingof providing these extra services at no extra fees.

The American doctor of the early 1900s carried few drugswhen he made housecalls, but according to the AmericanMedical Association, he knew the quality of each one of them.Calomel, opium, quinine, buchu (a diuretic to stimulate thekidneys), ipecac (an emetic), and Dover's powder (a laxative)made up his supply. At this time, medical therapeutics had notexperienced the same level of scientific revolution as medicaldiagnostics.

Since its introduction in 1899, aspirin (acetylsalicylic acid)has been the most popular drug of all time. By 1909, it rankedamong the 10 items most prescribed by American physicians,and the aspirin family had come to symbolize medicine's newtherapeutic accomplishments. (See "An Aspirin a Day... Just Another Cliche?" in the March-April 1999 issue of FDA Consumer.)

"In this century, medicine has seen the biggest change,"says John P. Swann, Ph.D., an FDA historian. "The history ofdrugs in the 20th century has completely changed the face oftherapeutics." Swann attributes the increase in overall life expectancy to improvements in surgery and medical technology,changes in nutrition and lifestyle, dedicated researchers, evolving sciences, committed institutions, economic and politicalcircumstances, and courageous practitioners and patients—allsocial, intellectual and technical links, he says, to good publich e a l t h .

In 1906, Congress passed the Food and Drugs Act in an effort to stop food adulteration and quack remedies—the twomajor evils and targets of a 25-year crusade for federal regulation of food and drugs. And the 1938 Federal Food, Drug, andCosmetic Act expanded the government's power to fight problems such as an upsurge of cheap, easy-to-get medical devices,which were promoted at the expense of reputable medicine.

The magnitude of changes that have occurred in the humanrace's relationship to infectious diseases during the 20th century is, according to historians, one of our biggest health successes. Vaccinations have essentially eradicated infectiouschildhood diseases in industrial ized countries. As a result of

improved health conditions, and particularly as a result of re-

The Electreat

Mechanical Heart

(shown at left) wasthe first medical

device seized un

der the 1938

Food, Drug, andC o s m e t i c A c t .

(Source: FDA History

Office)

duced infantile mortality, the average life expectancy, according to the national Centers for Disease Control and Prevention,increased in 1900 from 47 years to 67 years in 1950. And theU.S. Bureau of the Census projects that people born today canexpect to live well into their 70s.

Current advances in modern medicine may, to the laterskeptic, seem obsolete in the next millennium. HistorianRiddle, however, believes that medicine of the future will bean outgrowth of past and present medicine, but with the promise of even more effective remedies gleaned from new observations and experimentation.

"In the end," Riddle says, "we shall learn and marvel thatour ancestors were as intelligent and clever as we are." ■

Carol Lewis is a staff writer for FDA Consumer.

FDA Consumer / March-April 2000 / 13

The Death of the PartyAll the Rave, GHB's Hazards Go Unheeded

Caleb will sleep deeply for awhile, but then wake up and carry on.

Just check on him every so often to make sure he's positioned on his side

and still breathing, but don't bother calling 911 and incurring that huge

expense for nothing.

That, says Caleb Shortridge's stepmother, Anya, is what friends ad

vised Shortridge's roommate, Sarah, on April 30, 1998. On that hot San

Diego day, the thirsty Shortridge had taken a few chugs from a waterbottle his friend had set on the coffee table before realizing that the clear

liquid was not water, but GHB, or gamma hydroxybutyrate, says Anya.But, she adds, Shortridge and his friends weren't overly concerned about

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Caleb Shortridge was the last person friends thought would die from a GHB overdose.

the amount he drank of the euphoria-producing "party drug."

Shortridge was familiar with the drug,she explains, from the all-night "rave"dance parties that he and his friends frequented and where he sometimes performed as a disc jockey. In fact, sheadds, he was the person friends would goto for advice like "Which drugs can Itake safely?" and "Which shouldn't Imix together?"

So Shortridge's friends found it ironic,on top of tragic, Anya says, that he wasthe one who ended up dead at age 27from a drug overdose. "It gave them all awake-up call," she says.

Anya and Shortridge's father. Ken,now devote themselves to waking othersup to the life-threatening dangers of thedrug that took their son's life. Last Dec.3, they appeared on a "Leeza" talk showsegment on Sex, Drugs, and Death, sharing the stage with other families whoseloved ones were killed by party drugs.

Try as she might to alert people toGHB's dangers, Anya says, some peopleinevitably won't hear the message untilsomething terrible happens to them. "It'snaive people that are getting hurt," shesays. "We get letters saying, 'You don'tknow what you're talking about. If hehad done this properly ... If there wasthis circumstance ... If you know what

you're doing, this won't happen toyou.'"

But if you really do know what you'redoing, experts say, you know that anyone can accidentally overdose on GHB,also known on the street as %alty water,scoop, GBH, grievous bodily harm,Georgia home boy, liquid ecstasy, liquidX, somatomax, goop, or simply G.

By powerfully and rapidly depressingthe central nervous system, GHB canproduce an intoxicated feeling that hasearned it a reputation as a pleasure enhancer for thrill-seeking youngsters. Butits side effects can range from nauseaand vomiting to delusions, depression,vertigo, hallucinations, seizures, difficulty breathing, slowed heart rate, lowblood pressure, amnesia, and coma.

The U.S. Drug Enforcement Administration officially cites more than 45deaths and 5,500 emergency room overdoses associated with GHB. Since 1990,the Food and Drug Administration hasissued multiple warnings to consumersabout the drug's sometimes-deadlyeffec ts .

A C l e a r T h r e a t

GHB was first synthesized in 1960and, before its harmful potential becameknown, was sold at health food stores asa dietary supplement. In the '80s, GHB

was popular among bodybuilders because of its supposed ability to release agrowth hormone and stimulate musclegrowth.

But in 1990, based on more than 30reports of GHB-linked illness, FDA declared the product unsafe and illegal except in the carefully controlled environment of agency-approved drug studies.Still today, however, GHB continues tobe illegally promoted, not just for inducing an uninhibited high and buildingmuscles, but also for combating depression, aiding sleep, and fostering weightloss.

Last year, in response to renewedabuse of the drug, FDA reissued itswarning, telling consumers again aboutGHB's risks and reiterating that the drughas never been approved for sale as amedical product in the United States.

FDA has a lso warned consumersabout two potentially deadly "chemicalcousins" of GHB, which are precursorsof the drug that are converted into GHBin the body:• gamma butyrolactone, or GBL, whichis marketed under brand names such as

Renewtrient, Revivarant or RevivarantG, Blue Nitro or Blue Nitro Vitality, GHRevitalize!-, Gamma G, and Remforce.• 1,4 butanediol, abbreviated ED, achemical in products sold under brandnames like Revitalize Plus, Serenity, Enliven, GHRE, SomatoPro, NRG3, Thunder Nectar, and Weight Belt Cleaner.

Nationwide, the government's DrugAbuse Warning Network has tracked anincrease in GHB-related emergencyroom visits from 20 in 1992 to morethan 750 in 1997. (See page 19.) Butthese statistics are the "tip of the iceberg," warns rave drug specialist andformer narcotics detective TrinkaPorrata, who adds, "Kids are droppingl i ke fl i es . "

Two things help explain why officialreports under-represent the problem byfar, Porrata says: Emergency roomsoften can't detect or identify the drugbecause it leaves the body in about 12hours, and many doctors are not yet familiar with this relatively new drug ofa b u s e .

Despite the bleak statistics, youngpeople are freely experimenting withGHB. Cities reporting widespread use(Continued on page 18)

16 /March-April 2000 / FDA Consumer

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