politicized science the manipulated approval of ru-486 and its dangers to women's health

7/29/2019 Politicized Science The Manipulated Approval of RU-486 and Its Dangers to Women's Health

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Politicized Science:The Manipulated Approval o RU-486

and Its Dangers to Womens Health

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Family Research Council

Politicized Science:The Manipulated Approval o RU-486

and Its Dangers to Womens Healthby christopher m. gacek

christopher m. gacek, j.d., ph.d. is Senior Fellow orRegulatory Aairs at the Family Research Council.

politicized science: the manipulated approval of ru-486 and its

dangers to womens health

by christopher m. gacek

suggested donation: $1.50

2007 family research council

all rights reserved.

printed in the united states

I. IntroductionSince the Food and Drug Administration (FDA)approved the abortion pill RU-486 on September28, 2000, an estimated 600,000 American RU-486

abortions have been perormed. RU-486s abilityto bring an end to a human lie developing in thewomb is known to all, but the drugs considerableharmul eects on womens health have been mini-mized or ignored completely. Instead, the majormedia have been ully engaged in deending RU-486 despite an American track record that includesdeaths and over a thousand reports o complica-

tions many o them serious or lie-threatening.

Since 2000, several organizations, including theFamily Research Council, have unearthed a vastamount o inormation regarding saety concernsabout the drug, as well as evidence documentingthe Clinton Administrations manipulation o theFDA approval process.1 This pamphlet provides

an overview o what we now know about the drugsapproval and the dangers posed by RU-486 towomens health.

Much o the inormation used or this report was obtainedthrough Freedom o Inormation Act requests led byConcerned Women or America (CWA) and Judicial

Watch. The author would like to thank the American

Association o Pro Lie Obstetricians and Gynecologists(AAPLOG), CWA, and the Christian Medical andDental Association or permission to extensively reerencetheir Citizen Petition led with FDA (Aug. 20, 2002)(located at: );and the Response (Oct. 10, 2003) to the Population

Council ound on the same webpage.


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II. What is RU-486?

Since ancient times there have been many ailedattempts to produce chemicals capable o abort-ing pregnancies.2 Two millennia would pass be-ore modern science could design such a drug.3That drug was RU-486 or miepristone (also,Mieprex). In 1988 France became the rst thenation to license RU-486, and eorts were soonunder way to bring miepristone to market in theUnited States.4

Progesterone is the most important chemical inhuman pregnancy.5 It prepares the uterus or the

implantation o the embryo and plays an essentialrole in maintaining a pregnancy thereater. RU-486 acts as a progesterone antagonist because itprevents progesterone rom binding to its receptors,which are located in critical cells o the uterine lin-ing (i.e., endometrium). Metaphorically, RU-486is like a blank key that ts into a key hole butcannot turn the lock; this useless key (RU-486)

prevents a working key (progesterone) rom enter-ing the key hole and turning the locks mechanism.RU-486s blockade o progesterone receptors leadsto the deterioration o the uterine lining in whichthe embryo is implanted. As this deteriorationworsens, the uterus is no longer able to sustain thepregnancy and the embryo is destroyed.

The FDA-approved regimen calls or 600 mg oRU-486 to be taken within 49 days o the onseto the womans last menstrual period (reerred toas days LMP below). However, RU-486 cannotreliably kill the embryo and cause uterine evacua-tion o the dead tissue.6 Accordingly, misoprostolmust be taken one to two days ater RU-486 totrigger the uterine contractions needed to expel theremaining products o conception. Misoprostol(Cytotec) is a prostaglandin approved by the FDAto prevent ulcers in patients who take non-steroi-dal anti-infammatory drugs, but powerul uterinecontractions commence ater a pregnant womaningests misoprostol.7

Even when taken together, the RU-486/misopros-tol regimen requently ails. The American clinical

trials demonstrated that this regimen, which theFDA would later approve, was only successul in92% o pregnancies within 49 days LMP, 83% at56 days LMP, and 77% at 63 days LMP.8 Becauseo this high ailure rate and concomitant need orsurgical ollow-up, the FDA only approved themiepristone-misoprostol regimen or use out to

RU-486 developer Dr. Etienne-Emile Baulieu holds RU-486pills on October 31, 1988 in Paris. The FDA announced onSeptember 28, 2000 that the controversial abortion pill hadbeen approved or sale in the U.S.


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49 days LMP, but this restriction was essentiallymeaningless given the liberal o-label prescrib-

ing characteristics o U.S. ood and drug law.9

III. The Clinton Administration Finds

a Worthy PartnerIn the late 1980s and 1990s the abortion move-ment pushed to bring RU-486 to the United Statesor several reasons. First, it was believed that RU-486 would bring abortion into mainstream medi-cal practice where it could be prescribed widely.10Second, the abortion movement aced a steep de-cline in the number o doctors willing to perormsurgical abortions, and RU-486 was intended tobe a means whereby general practitioners couldperorm abortions.11 Third, making it possibleor non-surgeons to chemically abort pregnancies

would expand the geographical area in which abor-tions could be perormed. Fourth, i abortions wereperormed in settings other than abortion clinics(i.e., doctors oces), groups like Operation Rescuecould not interere with the procedure.12

President and Mrs. Clinton needed no encourage-ment to do the bidding o the abortion movement.

Both were, and are, deeply committed proponentso abortion on demand, and the proo o this camequickly. In his second ull day in ofce, January 22,1993, President Clinton directed Department oHealth and Human Services (HHS) SecretaryDonna Shalala to assess initiatives to promotethe testing, licensing, and manuacturing oRU-486 or other antiprogestins in the United

States.13

Donna Shalala and the administrationsFDA Commissioner, David Kessler, immediatelylaunched a major eort to nd an American RU-486 marketer. The administration was assistedby a major well-unded eort to place externalpressure on the drugs manuacturers, Roussel-Ucla (Roussel) and its parent, Hoechst. Three

organizations Feminist Majority Foundation,Reproductive Health Technologies Project, andAbortion Rights Mobilization ocused on thistask and other eorts to marshal public support.14

Kessler and others in the administration pressuredRoussel to assign its American RU-486 rightsto the Population Council, a New York-basedpopulation control group. On May 16, 1994, thePopulation Council was given the U.S. commer-cial rights to RU-486.15 This step would not havebeen taken without receipt o President Clintonsletter to Dr. Eduard Sarkiz, Chairman o Roussels

Supervisory Board, on May 16, 1994, stating thatit was important or the health o women in theUnited States that they have access to the widestpossible range o sae and eective medical treat-ments.16

Clinton administration memos discovered andpublished by Judicial Watch in 2006 are reveal-ing. For example, on May 11, 1994, HHS Chie

o Sta Kevin Thurm wrote a lengthy memoto Carol Rasco, Assistant to the President orDomestic Policy, discussing the steps needed tobring miepristone to market. Thurm stipulatedthat i Roussel were to provide inormation andtranser its technology to the Population Council,

Former HHS Secretary Donna Shalala and ormer U.S.President Bill Clinton


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an application could be led at the FDA in six totwelve months.17 He then added: Many o the

scientic decisions on the proper use and distribu-tion o the drug have already been considered bythe FDA, based on inormation already providedto FDA by Roussel and the Population Council.Roussel would not need to nish its United Statesclinical trials beore ling a marketing applicationwith FDA; such trials could be used to rene theuse o the drug at a later time.

Thurms comments are disturbing because theyindicate that important decisions about RU-486had been made long beore a company existed thatcould have submitted the requisite lings on thedrug. Additionally, the U.S. data was not availableor review, and these determinations were beingmade in a haphazard ashion ar outside the nor-mal channels developed by the FDA or the con-sideration o drug applications.

Six years were needed to obtain FDA approval, butspace does not permit a detailed description o allthe missteps that caused the delay.18 Eventually,Danco Laboratories (Danco), a company char-tered in the Grand Cayman Islands, was createdto market and distribute RU-486 in the United

States. Interestingly, the Population Council didnot transer its RU-486 patent rights to Danco.Furthermore, Danco is a one trick pony. It makesno other drugs, nor will it develop any. Danco ex-ists only to make and sell RU-486, and its lack oa drug pipeline decreases the regulatory leveragethe FDA can exert over it.

Finally, nothing says more about Dancos supposedconcern or womens health than the character oits medical director, Dr. Richard Hausknecht. In1994, Hausknecht was using methotrexate andmisoprostol o label in reelance abortion clinicaltrials. Dr. Mitchell Creinin, a top RU-486 abor-tion advocate, characterized Hausknechts behav-

ior as downright unethical.19 The experimentsended in September 1994 when the FDA ordered

Hausknecht to stop perorming the abortions un-less he gets the backing o a medical institutionand submits his data and procedures to the FDAor review.20

IV. The FDA Considers and

Approves the RU-486 Application

(1996-2000)The Population Council led its New Drug Ap-plication (NDA) on March 18, 1996. The FDAsReproductive Health Drugs Advisory Committee(Advisory Committee) met on July 19, 1996, toconsider aspects o the application.21 The meetingwas noteworthy or several reasons.

First, the Advisory Committee approved o RU-486s saety and eectiveness based on French datasupplied to the applicant by Roussel. Preliminaryresults o the American trials were available, butthe American data was not sucient or approval.The FDA does not typically approve a drug basedprimarily on oreign data. Dr. Mary Jo OSullivan,a member o the Advisory Committee, asked whythe meeting was being held at this time when the[U.S.] data is not nalized.22 Not only was thedata not nalized, but the Advisory Committeewas never reconvened to consider the completedAmerican trial data. The American data present-ed a lower completed abortion rate than did theFrench data, and that data should have been pre-sented to the Committee.

Second, in June 1996 the FDA inspected the re-ports rom Roussel underlying the French data andound them to be marked by carelessness, raud,evidence tampering, and the systematic under-reporting o serious adverse events.23 The un-der-reporting consisted o accounts o a patient


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bleeding with two subsequent aspirations; convul-sions reported as ainting; and expulsion which was

actually a surgical evacuation; bleeding, nausea andcontractions, or bleeding and pelvic pain.24 TheFDA admonished the French investigator but stillaccepted the data. Worse yet, the FDA did not tellthe members o the Advisory Committee that thequality o the data was suspect and rule violationshad been ound.

Third, FDA Commissioner David Kessler, M.D.,chaired the Advisory Committee meeting. Givenhis aggressive actions to obtain rights to the drugor the Population Council, this should not surpriseus. However, later events revealed the extent o

Kesslers pro-abortion partisanship. On January 18,2005, David Kessler was given a lietime achieve-ment award by NARAL Pro-Choice America.25At the award dinner Kessler said, The threat to awomans right to choose concerns me gravely as acitizen and as a physician.26 Later, as Dean o theSchool o Medicine o a Caliornia university, Kes-

sler addressed NARALs Sixth Annual PeninsulaPower o Choice Luncheon, a undraiser held in

Palo Alto, Caliornia, on October 4, 2006.

Fourth, the Advisory Committee members weremarked by conficts o interest and bias. Eighto the 11 members were either aliated with anabortion organization or ha[d] made pro-choicestatements in the past.27 The committee chair-man, Ezra Davidson, served on Planned Parent-

hoods advisory board in 2002.

28

Jane Zones andDeborah Narrigan were members o the AdvisoryCommittee, and both had been board memberso the pro-abortion lobbying group, the NationalWomens Health Network.29 Finally, the AdvisoryCommittees executive secretary was Philip Cor-man, M.D., who served as an advisory committeemember or the pro-abortion Center or Repro-ductive Health Research and Policy, and currentlysits on the board o directors or the pro-abor-tion Reproductive Health Technologies, discussedabove, where his web bio boasts o his role in theRU-486 approval.30

Fith, the Population Council established a non-prot organization, American Health Technolo-gies (AHT), to market RU-486; Danco was

created later. AHTs president and CEO was Dr.Susan Allen, M.D. Allen was not an obstetrician-gynecologist.31 Her testimony beore the AdvisoryCommittee alarmed the doctors when she sug-gested that non-surgeons could be instructed in acouple o days at training seminars to saely per-orm D&Cs, the surgical procedure that cleans theuterus o its contents.

The Advisory Committees Decision

At the public hearing, the Advisory Committeevoted 6-2 that ecacy had been established. Twomembers (Henderson and OSullivan) voiced con-cerns about the data presented. OSullivan wanted

Former FDA Commissioner Dr. David Kessler


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to see the American data. An unnamed memberthought that worse U.S. data should prompt an-

other meeting to be held. The Committee voted7-0-1 (1 abstention) in avor o saety and 6-2 thatthe benets o the drug exceeded its risks.

The Home Stretch or RU-486(1999-2000)

By the late 1990s it was clear to the FDA that

RU-486/misoprostol abortions would not kill theembryo and evacuate the uterus in a signicantpercentage o cases.32 Such uterine contents wouldhave to be removed surgically.

There were other serious side eects that had to bemonitored as well (e.g., severe hemorrhage and themasking o ectopic pregnancies by the symptomsaccompanying a medical abortion). The FDA ap-

pears to have concluded in 1999 that additionalsaety requirements were needed or the drug tobe marketed saely. Nevertheless, the PopulationCouncil was largely uncooperative.33 In order togain greater regulatory leverage over the drug, theFDA appears to have decided to consider RU-486 under the restricted distribution provisions o

its accelerated approval regulationsknown asSubpart H.34

The FDAs Accelerated Approval orSubpart H Regulations

HIV/AIDS prompted the FDA to reconsider itsdrug approval process in the 1980s-1990s. Crit-ics argued that new drugs could be approved morequickly i they were tested not or their eect on

hard endpoints like morbidity and mortality buton endpoints that could act as their surrogates.35In December 1992 the FDA approved its SubpartH regulations to address this problem or certainnew drug products that have been studied or theirsaety and eectiveness in treating serious or lie-threatening illnesses . . .36 In addition to the sur-rogate endpoint eature just described,37 Subpart

H also contained a rule section dealing with theapproval o drugs whose distribution was restricteddue to hazards presented by the drug. Indeed, RU-486 was approved using this provision.38

Political Pressure OverturnsFDA Saety Precautions Proposed

in June 2000

Around June 1, 2000, the FDA privately proposeda list o Qualications or Physician Recipients.They were: (1) physicians prescribing RU-486would have to be licensed to practice medicine;(2) physicians would have to be trained to perormsurgical abortions; (3) the physician would have tobe trained to evaluate the age o the pregnancy us-ing ultrasound;39 (4) the physician would have tobe able to use ultrasound to conrm an intrauter-ine pregnancy (i.e., not ectopic); (5) the physicianwould have to have satisactorily completed train-ing certied by the distributor in the miepris-tone treatment procedure, including mechanismo action, appropriate use, proper administration,


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Scha, an RU-486 advocate and researcher, toldthe New York Times that such restrictions would

kill the drug i it cant be used by primary careproviders.45 Scha also pointed out the obvious:The whole idea o miepristone was to increaseaccess.46

Pro-abortion poli-ticians soon rearedtheir heads. For ex-ample, Senator Bar-bara Boxer (D-CA)wrote to Dr. Henneyon June 9, 2000:

According tonews reports, theFDA is consider-ing placing draco-

nian restrictionson the accessibil-ity o RU-486as a condition oits approval . . . In1996, the FDA ound RU-486 to be sae andeective. Thereore, it is a mystery to me whythe FDA would even consider restricting access

to it.47

On June 22, 2000, U.S. Representative LynnWoolsey (D-CA) wrote to Dr. Henney, statingthat she was deeply concerned about recent pressreports about proposed restrictions. 48 The PublicAdvocate or the City o New York, Mark Green,a long-time New York liberal politico, wrote to Dr.Henney on September 22, 2000. Green inormedher: Earlier this week Planned Parenthood oNew York City, NARAL-New York, the AccessProject and Physicians or Reproductive Healthand Choice joined me in convening a public hear-ing in New York City on pending action by [FDA]on miepristone He added that he was also

12

ollow-up, ecacy, adverse events, adverse eventreporting, complications, and surgical indications;

and (6) the physician must have continuing ac-cess (e.g., admitting privileges) to a medical acilityequipped or instrumental pregnancy termination,resuscitation procedures,40 and blood transusion atthe acility or [one hours] drive rom the treatmentacility.41

Items 1 and 2 attempted to ensure that licensedphysicians capable o perorming surgery wouldprescribe RU-486. Item 3 ocused on the act thatRU-486s ailure rate increases dramatically aterthe 49th day o pregnancy LMP; only ultrasoundevaluations can accurately indicate whether a preg-nancy is beyond Day 49. Item 4 refected the actthat giving RU-486 to a woman with an ectopicpregnancy is orbidden, and ultrasound is the stan-dard method used to locate a pregnancy. Item 5refected the act that a drug as dangerous as RU-486 should only be given by doctors trained in itsuse. Finally, Item 6 is most revealing. The FDAdetermined that it would be dangerous or a wom-an taking RU-486 not to be in the care o a physi-cian who could quickly admit her into a properlyequipped hospital.42 This list should make any butthe most biased observer realize that RU-486s use

is complicated and raught with dangers.

The reaction o the Population Council, the abor-tion industry, and the pro-abortion press came astand urious. The Population Council and Dancoobjected strenuously to the proposed restrictions,and leaked stories to the press claiming that theFDAs proposals regarding the labeling and dis-

tribution o miepristone would severely limitwomens access to the drug i and when it is ap-proved.43 The American Medical Association andthe American College o Obstetricians and Gyne-cologists (ACOG) aggressively acted to persuadethe acting FDA Commissioner, Jane Henney, toreverse the FDAs proposed restrictions.44 Dr. Eric

Barbara Boxer (D-CA)


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concerned about the restrictions on access to RU-486 that FDA is said to be considering.49

The nal shoe dropped at the FDA itsel. You mayrecall Susan Allen, described above, with regard toher 1996 testimony at the FDAs RU-486 hearing.In 1998 Allen was hired to work in the FDAs Re-productive and Urologic Drug Products Divisionin the FDAs Center or Drug Evaluation and Re-search (CDER). This division oversaw process-ing o the RU-486 application. She was promotedto team leader or reproductive drugs in 1999.Allenwho, as noted, was not an obstetrician-gynecologistbecame acting director o the Divi-sion in January 2000 and permanent director onJune 18, 2000.50 Even though Allen had to recusehersel rom direct involvement in the RU-486 ap-proval, it is hard not to conclude that she was giventhis position to send a career-dening message tothe division sta.

In any event, the FDA quickly abandoned its pro-posed physician qualications. The agency evengave ground on issues not even raised by the June1, 2000 proposal.51 By mid-July 2000 the FDAwas in ull retreat, and RU-486 was approved pur-suant to its Subpart H regulations on September

28, 2000.

V. The FDA Violates Its Rules in

Approving RU-486The FDA approval o RU-486 was problematic le-gally in several ways.

First, even though the Food, Drug & CosmeticAct prohibits approval o a drug application basedsolely on uncontrolled clinical trials, the FDAdid exactly that. The RU-486 trials were uncon-trolled because the drug was never compared to acontrol group o women having surgical abortion.Comparison o the test group with a control group

is needed to eliminate investigator (and agency)bias.

Second, RU-486 did not qualiy or Subpart Happroval because pregnancy is not a serious orlie-threatening illness. Additionally, the FDAsailure to conduct controlled comparisons o RU-486 and surgical abortions was especially egregious

because Subpart H explicitly requires a demonstra-tion o therapeutic benetover existing treat-ments.52 Subpart H provides these exampleso therapeutic benet: the ability to treat patientsunresponsive to, or intolerant o, available thera-py, or improved patient response over availabletherapy.53 Women who have standard RU-486abortions must be able to tolerate a D&C becausethe RU-486/misoprostol abortion regimen has asubstantial chance o ailure: a surgical procedureis the back-up or RU-486 users. Furthermore,a head-to-head comparison o abortion methodswould have shown RU-486 to be demonstrably


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less eective and less sae.54 In sum, RU-486 doesnot provide the requisite benets.

Third, the agency mandated a previously unap-proved use or misoprostol. Misoprostol was ap-proved by the FDA to prevent people who takenon-steroidal anti-infammatory drugs (e.g.,ibuproen) rom getting ulcers. When given topregnant women it causes uterine contractionsto commence. When it approved the RU-486regimen, the FDA mandated that a new, unre-

lated indication or misoprostol be placed on themiepristone label (i.e., the package insert). PeterBarton Hutt, a ormer FDA general counsel, ob-served that the agencys treatment o misoprostolsets an extra-ordinary precedent because theFDA [is] seemingly encouraging a drugs unap-proved use.55 The FDA has been adamant oryears in stopping pharmaceutical companies rom

promoting a drug or purposes other than thoseapproved by the agency. Thus, every copy o theRU-486 label distributed by Danco, approved bythe FDA, promotes a required o-label use o thedrug.

VI. RU-486 Endangers the

Lives and Health o the WomenWho Use It

Six years o RU-486 adverse event reports (AERs)have produced real world data not available be-ore the U.S. approval.56 The FDA reporting sys-tem or drug complications is voluntary, so thereis large-scale underreporting o drug side-eects.

The FDA has estimated that it receives reports oronly 1-10 percent o drug complications.57 In thecase o miepristone, providers agree to report com-plications to Danco. However, the AERs revealthat a sizable proportion o women with RU-486complications have to seek medical attention inemergency rooms. ER doctors have no obligation

to report RU-486 adverse events. A generous esti-mate would be that the FDA is receiving reports

on only 3-4 percent o RU-486 complicationsatmost.58

Nevertheless, the 1,000+ reports are signicantbecause they conrm that large numbers o mie-pristone patients require surgical intervention orinection, hemorrhage, complications rom ecto-pic pregnancy, and incomplete abortions. Suchcomplications could not be a surprise to the FDA,or they were well-known and documented by theearly 1990s.59 One recent article has been pub-lished by two obstetrician-gynecologists, PeggyGary and Donna Harrison, who analyzed 607 othe American AERsthe total then available.60Since the publication o that article, the FDA hasstopped releasing AERs pertaining to RU-486 a-talities that have been requested pursuant to theFreedom o Inormation Act.

Inection

To date there have been six North American deathsstemming rom the use o the RU-486 abortionregimen.61 Five Americans and one Canadianhave died rom septic shock stemming rom inec-

tion by the anaerobic bacteria Clostridium sordellii.One o those young women was Holly Patterson,18, o Livermore, Caliornia. Her death becameknown nationally, and her ather, MontgomeryPatterson, has been heroic in attempting to com-pel the FDA to recognize RU-486s saety prob-lems. Ater notiying the public o the third andourth septic shock deaths in July 2005, the FDA

took the unusual step o releasing an FDA PublicHealth Advisory on July 19, 2005.62 On that daythe FDA also announced that the PrescribingInormation, Medication Guide, and PatientAgreement or Mieprex (miepristone) have beenupdated to convey inormation concerning inec-tion with Clostridium sordellii.63


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In women o childbearing age lethal inectionscaused by C. sordellii were rare in the U.S. prior

to RU-486s approval. Aside rom blocking pro-gesterone receptors, two scientists have writtenindependently that RU-486 may impair the in-nate immune systemmaking possible the suddenonset o septic shock.64 In addition to the deaths,Gary and Harrison ound 66 inection cases in theirreview o FDA AERs.65 At least 46 were serious orlie-threateningtwo o these inections occurred

in girls age 13-17 years old. Four women whosurvived lie-threatening inections were in sep-tic shock at the time o presentation to the emer-gency room.66 Inection is a serious gynecologicalproblem because women oten develop pelvic in-fammatory disease (rom inection in the uterus,Fallopian tubes, and ovaries). Approximately onein our o these women will eventually be diag-

nosed with a blockage o the Fallopian tubes thatrenders them sterile.

18

On May 11, 2006, the Centers or DiseaseControl (CDC) in Atlanta hosted a conerence,

Emerging Clostridial Disease Workshop, whichocused, in part, on the C.sordelliideaths.67 A u-ture research agenda developed rom the coner-ence has yet to be announced. An important aspecto the conerence was the revelation that variousstudies, one involving the use o RU-486 in miceand published in 1992,68 have noted that the in-terruption o the innate immune system can cause

highly elevated rates o septic shock in selected labanimals. RU-486s cortisol-blocking propertiesgive the chemical this abilitywhich some likento removing the adrenal gland.

Hemorrhage

The FDA inormed Chairman Mark Souder that

116 cases o severe bleeding requiring transu-sions had been reported to the FDA by March 31,2006.69 Gary and Harrison reported that 237 otheir 607 AERs reported hemorrhage and that 42cases were lie-threatening.70 All o the patientswho experienced lie-threatening bleeding wouldhave died had they not received timely access tomedical and surgical services. One Swedish teen-ager did bleed to death. In December 2006 thedeath o a 31 year-old healthy Taiwanese mothero two, who used RU-486 as an abortiacient, wasreported. 71

The heavy bleeding produced by miepristone-prostaglandin abortions was well known in the1990s. 72 A British multi-center trial (1990) hadve o 579 women receive transusions and curet-

tage.73 One U.S. study participant wrote in theLos Angeles Times in 1990 that she continued tobleed or three months ater her abortion.74 In theU.S. clinical trial, excessive bleeding necessitatedblood transusions in our women (n=2015) andaccounted or 25 o 27 hospitalizations (includ-

19


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ing emergency-room visits).75 One participantrom Iowa almost bled to death and was saved only

by rapid surgical intervention and transusions.76

The FDAs Janet Woodcock nonchalantly told acongressional subcommittee that the agency ullyexpected this pattern o hemorrhage when it ap-proved the drug. In her testimony to ChairmanMark Souder in May 2006, Woodcock seemed tobelieve that the FDAs mere expectation and ap-parent prediction o such serious side eects made

the agencys judgment immune rom criticism.

Ectopic Pregnancies

Two percent o American pregnancies are ecto-pic. That is, they develop outside the uterususually in the allopian tubes. When an ectopicpregnancy ruptures, the woman will rapidly bleed

to death internally unless she undergoes immediatesurgery. The signs and symptoms o ectopic preg-nancy (e.g., cramping and bleeding) resemble thoseexperienced by a woman undergoing an RU-486abortion. An endangered RU-486 patient mightdelay treatment thinking her symptoms were dueto the RU-486 abortionnot an ectopic pregnan-cy. Gary and Harrison ound 17 AERs involvingectopic pregnancies including 11 ruptures and onedeath.

Surgical Abortionists on RU-486

RU-486s track record in the U.S. has come undercriticism even rom abortionists. E. Hakim-Elahi,M.D., looked at Planned Parenthoods 2003 re-ported complications and concluded in a letter to

Ob.Gyn News: I I were to receive such a reportrom a surgical abortion clinic, I would recom-mend to health authorities that the clinic be im-mediately shut down.77 Hakim-Elahi declaredfatly, Medical abortion with the present drugregimen is unsae.78

Following the announcement o another RU-486death in March 2006, aNew York Timesarticle car-

ried statements rom abortionists who expresseddoubt about the regimens saety.79

Dr. Warren Hern o Denver, Colorado, assertedthat using drugs [is] a lousy way to perorm anabortion.80 Additionally, the Times interviewedDr. Damon Stutes o Reno, Nevada who agreedwith Hakim-Elahi and Hern: The complicationsassociated with RU-486 ar exceed the complica-tions o surgical abortion.81 While admitting thathe was uncomortable in agreeing on anythingwith abortion opponents, he said, But the truthis the truth.

VII. ConclusionIn retrospect it is clear that those pushing or U.S.

approval o RU-486 lived under a set o delusionsabout the drugs potential political and proessionalimpact. RU-486 has produced none o the eectso normalizing abortion that were predicted or it.RU-486 is not accepted as a compromise politically,and it has not attracted doctors willing to use it. Tothe contrary, RU-486 has been a public relationsdisaster or the abortion movement as its maniest

dangers have had to be repeatedly explained away.

The Clinton administration twisted pharmaceuti-cal industry arms and broke rules to orce RU-486approval through the FDA. RU-486 and surgicalabortions were not compared in trialsas requiredby scientic standards. Sta concerns about RU-486s saety were crushed politically.

Despite the Clinton administrations Herculeaneight-year eort to bring the drug to market,RU-486 was just becoming widely available whenGeorge W. Bush assumed the presidency. Conse-quently, the overwhelming proportion o RU-486sadverse events and 600,000 deaths in the womb

20 21


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23

footnotes

1 RU-486 is not a morning ater pill or an emergencycontraceptive like Plan B. RU-486 destroys an embryoor etus already implanted in the uterus.

2 Bernard N. Nathanson, Drugs or the Production oAbortion: A Review, 25 Obstetrical and GynecologicalSurvey (1970, no. 8): 727-731, 728. For an encyclo-pedic discussion o the history o abortion techniques,seeJoseph W. Dellapenna, Dispelling the Myths o Abor-tion History (Durham, N.C.: Carolina Academic Press,2006): 29-56.

3 Methotrexate, a olic acid antagonist developed or usein chemotherapy, has been used o label to produceabortions since the 1970s. An o-label use constitutesa lawul but unapproved use. See O-label use at

Wikipedia (go to: ). On methotrexates use as an abortiacient, seeBernard N. Nathanson, M.D., The Abortion Cocktail,First Things 59 (January 1996): 23-26 (go to: ). SeeDellapenna, note 2 above, or a discussion othe toxicity and ineectiveness o abortiacients prior tothe advent o RU-486.

4 Lawrence Lader, A Private Matter: RU 486 and the Abor-tion Crisis (Amherst, NY: Prometheus Books, 1995):115-241.

5 I one breaks down progesterone, one sees in its roots

pro- and -gestation.6 Irving M. Spitz, M.D., C. Wayne Bardin, M.D., Lauri

Benton, M.D., and Ann Robbins, Early PregnancyTermination with Miepristone and Misoprostol in theUnited States, New England Journal o Medicine 338(Apr. 30, 1998): 1241-47, 1243 (Table 1). In the U.S.Clinical Trials, miepristone alone produced successulabortions in only 40% o pregnancies within 49 daysLMP, 12% at 56 days LMP, and 4% at 63 days LMP.

7 Misoprostol is now used in standard obstetrical practiceto induce labor in women whose pregnancies are at ullterm.

8 Spitzet al., 1242-1243 (incl. Table 1).

9 Soon ater the FDA approved RU-486, Planned Parent-

have occurred during President Bushs presidencyand his partys control o Congress. Both the GOP

president and Congress knew o the approval ir-regularities and dangers posed by RU-486, yet noserious eort was made to correct the situation. Oall the committees and subcommittees on the Hill,only Representative Mark Souders held a hearing(on May 17, 2006) to explore miepristones saety.

The President needs to remedy the threat towomens health posed by RU-486. Six years oAmerican RU-486 use have made clear that RU-486 doesnt just kill the unbornit endangers thelives o those who use it. President Bush shoulddo the right thing and reverse this approval basedon the abuse o process that gained its approvaland the dangerousness that characterizes RU-486.Respect or the law and concern or womens healthdemand no less.

Ater the septic shock deaths o several women who receivedRU-486 rom its clinics, Planned Parenthood adopted a newo-label RU-486 regimen on March 17, 2006.

22


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hood, the National Abortion Federation, and ACOGmoved to an o-label regimen in which 200 mg. RU-486

would be taken orally with 800 micrograms o misopros-tol administered vaginally. Planned Parenthood also ad-ministered the RU-486 out to 63 days LMP. However,Planned Parenthood abandoned that regimen on March17, 2006 and now administers RU-486 only to 56 daysLMP with oral misoprostol administration. NAF doesnot appear to have adopted the new Planned Parenthoodprotocol. SeeACOG Practice Bulletin, No. 67, Medi-cal Management o Abortion, Obstetrics & Gynecology(October 2005); 106: 871-82; see also, National Abortion

Federation, NAF Protocol or Miepristone/Misopro-stol in Early Abortion (Washington, D.C.: NationalAbortion Federation, March 2006).

10 Margaret Talbot, The Little White Bombshell, NewYork Times Magazine ( July 11, 1999): 39-43 (go to:). (One o my real hopes or this method, says Carolyn Westho, anOB-GYN at Columbia University medical school who

oers medical abortion as part o a clinical trial, is that itwill help get abortion back into the medical mainstreamand out o this ghettoized place its been in. And i thatis indeed the scenario were looking at a scenario in

which abortion is olded ar more seamlessly into regularmedical practice then it has implications not only or

womens experience o abortion but or the politics oabortion as well.)

11 Talbot, The Little White Bombshell, (Not only are

miepristone abortions, by nature, more discreet thantheir surgical equivalents (like vacuum aspiration), butthe practitioners who prescribe them will almost cer-tainly constitute a larger and a more varied group thanthe dwindling corps o OB-GYNs willing to do surgicalabortions.); also, David A. Grimes, M.D., Clinicians

Who Provide Abortions: The Thinning Ranks, Obstet-rics and Gynecology80 (October 1992): 719-723 (Accessto abortion services in the United States has become in-creasingly limited because o a decrease in rural hospital

providers and a growing shortage o clinicians willingto oer this service. As o 1988, 83% o United Statescounties had no identied provider.).

12 Lader,A Private Matter, 225.

13 Importation o RU-486, Memorandum or the Sec-retary o Health and Human Services, Public Papers o

the Presidents: Administration o William J. Clinton, 1993( Jan. 22, 1993), 11. As will be discussed below, anantiprogestin is a drug that blocks the unctioning oprogesterone.

14 For a detailed account o the Feminist Majority Founda-tions campaign to bring RU-486 to the United States,see Jennier Jackman, Anatomy o a Feminist Victory:

Winning the Transer o RU 486 Patent Rights to theUnited States, 1988-1994, Women & Politics, vol. 24(3): 81-99. Jackman served as Director o Policy andResearch or the Feminist Majority Foundation.

15 Judicial Watch, The Clinton RU-486 Files (Wash-ington, D.C.: 2006); go to: http://www.judicialwatch.org/printer_5769.shtml.

16 Judicial Watch, The Clinton RU-486 Files, Tab E.

17 Kevin Thurm, HHS Chie o Sta, Memo to CarolRasco, Assistant to the President or Domestic Policy(May 11, 1994); seeJudicial Watch, The Clinton RU-486 Files, Tab D.

18 Randy OBannon, Extensive Background Inormationon RU-486 (Washington, D.C.: National Right to Lie,2001) succinctly describes the complex nancial and cor-porate arrangements made to bring RU-486 to market(go to: ).

19 Carol Jouzaitis, Doctors Abortion-Drug TechniqueDraws Fire, Chicago Tribune(Sept. 12, 1994): 1, 14.

20 Ibid.

21 Hearings on New Drug Application or the Use o Miepris-tone or Interruption o Early Pregnancy (July 19, 1996),FDA Advisory Committee (FDA Miepristone HearingsTranscript). Transcript may be ound on the internetat: .

22 FDA Miepristone Hearings Transcriptat 37.

23 American Association o Pro Lie Obstetricians and Gy-necologists, Christian Medical and Dental Association,and Concerned Women or America, Citizen Petitionre: Request or Stay and Repeal o the Approval o Mieprex(miepristone) or the Medical Termination o IntrauterinePregnancy through 49 Days Gestation, beore the Depart-ment o Health and Human Services, Food and Drug

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Administration (August 20, 2002), 40-41 (cited asCitizen Petition).

24 Citizen Petition, 41.

25 David Brody, RU-486: The Uncontrolled Birth ControlPill, Christian Broadcasting Network (Feb. 28, 2005)(available at: ). NARAL, which stands or National

Abortion Rights Action League, was the organizationsprevious name. The group was ounded in 1969 by Ber-nard Nathanson, Larry Lader, and Betty Friedan.

26 Ibid.

27 Ibid.

28 Planned Parenthood is the largest abortion provider inthe United States.

29 Jones participated as consumer representative at themeeting but did not vote on the RU-486 questions; Nar-rigan did vote or approval o the RU-486 NDA.

30 Cormans biography reads: Philip Corman was therst Director o the Center or Population Research atNIH and subsequently held a similar position at the

World Health Organization in Geneva. Following this,he held leadership positions or the review o new drugsand devices or reproductive health at the FDA and was amajor participant in the FDAs eort to make emergencyhormonal contraceptives and miepristone available to

American women. This webpage may be ound at:

.

31 FDA Miepristone Hearings Transcriptat 317. Allen stat-ed during her testimony that she was not an OBGYNphysician. Id. at 321.

32 Spitz, et al., 1242-1243 (incl. Table 1).

33 Citizen Petition, 49-55.

34 The FDAs Accelerated Approval Regulations are setorth at 21 C.F.R. Part 314, Subpart H (Accelerated

Approval o New Drugs or Serious or Lie-Threaten-ing Illnesses) (Subpart H). See21 C.F.R. 314.500.Drugs approved under Subpart H may be ound at: http://

www.da.gov/cder/rdmt/accappr.htm#NDAsApprovedUnder Subpart H.

35 In the 1992 notice o rulemaking, the FDA describeda surrogate endpoint as a laboratory measurement orphysical sign that is used in therapeutic trials as a substi-tute or a clinically meaningul endpoint that is a directmeasure o how a patient eels, unctions, or survives andthat is expected to predict the eect o the therapy.

36 21 C.F.R. 314.500.

37 21 C.F.R. 314.510 (Surrogate Endpoints).

38 21 C.F.R. 314.520(a). The FDA rst used the re-stricted distribution provision o its rules in 1998 to ap-

prove the dangerous drug, thalidomide, to treat leprosy.

39 The only way that a pregnancys age can be determinedaccurately is to date the pregnancy using ultrasound.

40 Resuscitation procedures implies that the medical a-cility would have a crash cart and personnel trained in

ACLS (Advanced Cardiac Lie Support) and ATLS(Advanced Trauma Lie Support). The personnel atthe medical acility would be trained in rapidly starting

an IV, intubation, cardiac debrillation, and administra-tion o lie saving medications. Medical acilities withan Emergency Room routinely have a crash cart andpersonnel trained in working through a Code Blue.

41 Citizen Petition, 52-3, n.235.

42 Many abortionists do not have admitting privilegesat hospitals. For example, one Supreme Court justicenoted in 1999 that Leroy Carhart, M.D., a notorious

partial-birth abortionist, lack[ed] admitting privilegesat any hospital. Stenberg v. Carhart, 530 U.S. 914, 956(2000) (Kennedy, J., dissenting). One would want anRU-486 prescriber to have admitting privileges at anearby hospital to protect the health o the patient be-cause dumping the patient into the local emergencyroom is dangerous. In general, emergency room (ER)physicians are not trained to perorm D&Cs. Handlingemergency hemorrhage caused by retained productso conception or severe uterine inection requires theperormance o a D&C or, even, a hysterectomy. Thephysician would have to admit the patient to the hospital

where he/she would have operating privileges; however,the physician needs to have admitting privileges at thathospital. There would be a dangerous delay in havingthe ER physician locate an on-call OB/GYN to cometo the hospital to treat a bleeding emergency.

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43 Citizen Petition, 53, n. 237. Normally, such behavior bya drug company during the FDA approval process wouldget a companys drug application buried i not killed.

44 Citizen Petition, 53, n. 239.

45 Sheryl Gay Stolberg, F.D.A. Adds Hurdles in Approvalo Abortion Pill,New York Times( June 8, 2000). Notethe papers bias in characterizing the proposed restric-tions as hurdles rather than as saety precautions.

46 Ibid.

47 Citizen Petition, 54, n. 240 (seeLetter, Senator BarbaraBoxer to Dr. Jane Henney, Acting FDA Commissioner.

June 9, 2000: 1).

48 Ibid. (see Letter, U.S. Representative Lynn Woolsey toDr. Jane Henney, Acting FDA Commissioner, June 22,2000: 1).

49 Ibid. (seeLetter, Mark Green, Public Advocate or theCity o New York, to Dr. Jane Henney, Acting FDA

Commissioner, Sep. 22, 2000: 1).

50 Citizen Petition, 9, n. 24.

51 Citizen Petition, 54-57.

52 21 C.F.R. 314.500.

53 Ibid.

54 Citizen Petition, 21-22 (citing and quoting Jerey T.

Jensen, Susan J. Astley, Elizabeth Morgan, and MarkD. Nicols, Outcomes o Suction Curettage and Mie-pristone Abortion in the United States: A ProspectiveComparison Study, Contraception 59 (1999): 153-159).

Jensen et al. noted that RU-486 abortion patients re-ported signicantly longer bleeding and signicantlyhigher levels o pain . . . , nausea . . . , vomiting . . . , anddiarrhea than the surgical abortion patients. Ibid.

55 Rachel Zimmerman, Clash Between Pharmacia and

FDA May Hinder the Use o RU-486, Wall Street Jour-nal(Oct. 18, 2000): B1. Hutt added that the agency isin an embarrassing and uncomortable position.

56 All condential or patient-identiying inormation isstripped rom these reports by the FDA beore releaseunder the Freedom o Inormation Act.

57 Frontline, Dangerous Prescription, FAQs & Links,posted Nov. 13, 2003 (see How does the FDA nd outabout adverse events? at: http://www.pbs.org/wgbh/

pages/rontline/shows/prescription/etc/links.html ).

58 In May 2006, the FDAs Janet Woodcock testied beorea House subcommittee that, based on numbers providedby Danco, 575,000 women had been exposed to RU-486. At the time the FDA had received approximately1,000 unique AERs related to RU-486s use as an abor-tiacient. In a March 2004 ling Planned Parenthoodand the National Abortion Federation, responding to theCitizen Petition, admitted that ve per-cent o womenneeded surgical intervention to complete an RU-486abortion. Five per-cent o 575,000 equals 28,750. Onethousand (received reports) divided by 28,750 (expectedailures given total abortions) equals three and a halper-centa generous estimate. SeeStatement o Janet

Woodcock or the Souder Hearing (May 17, 2006). Dr.Woodcocks statement and other documents pertainingto the Souder Hearing except or the sta report areavailable at: ().

59 Janice G. Raymond, Renate Klein, and Lynette J.Dumble, RU 486: Misconceptions, Myths, and Morals(Cambridge, Mass.: Institute on Women and Technol-ogy, 1991), 31-47 (go to: ).

60 The AERs had been led with the FDA between Sep-tember 2000 and September 2004. See Margaret M.

Gary, M.D., and Donna J. Harrison, M.D., Analysiso Severe Adverse Events Related to the Use o Mie-pristone as an Abortiacient,Annals o Pharmacotherapy(published online Dec. 27, 2005) (www.theannals.com).

61 It appears that all o the women used a 200 mg RU-486 (oral), 800 mcg misoprostol (vaginal) regimen. TheCanadian died as part o a clinical trial or RU-486. TheCanadian miepristone trial was ended ater this 26 year-old womans death in August 2001. RU-486 has still not

been approved by Canadian drug authorities.

62 For the advisory, go to: (updated 11/04/05).

63 Go to: .

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64 Two scientists have independently oered similar analy-ses o a relationship between RU-486 and septic shock.R.P. Miech, M.D., Ph.D., Pathophysiology o Miepris-

tone-induced Septic Shock due to Clostridium sordellii,Annals o Pharmacotherapy39 (Sep. 2005): 1483-8; Letterto the Editor, James A. McGregor, M.D., Contraception72 (2005): 393.

65 Chairman Souder was told o 88 inection cases overa longer period o time. Letter rom David W. Boyer,

Assistant Commissioner or Legislation, FDA, to Hon.Mark E. Souder, Chairman, Subcommittee on Criminal

Justice, Drug Policy and Human Resources, Commit-tee on Government Reorm, House o Representatives(May 2, 2006), 8 (Boyer May 2, 2006 Letter).

66 Gary and Harrison, 2.

67 Inormation and papers related to the workshop may beound on the webpage: . Doctors Miech and Mc-Gregor gave presentations at the CDC workshop.

68 Lazar et al., Modication o Septic Shock in Mice bythe Antiglucocorticoid RU-38486, Circulatory Shock36(3): 180-4 (1992).

69 Boyer May 2, 2006 Letter, 8.

70 Lie-threatening cases were dened by active hemor-rhaging with hemoglobin less than 7 g/dL and thetransusion o 2 or more units o packed red blood cells(PRBCs).

71 Lo Woei Chung et al., Letter to the Editor, Thromboticthrombocytopenic purpura secondary to miepristone ina patient o medical termination in early pregnancy,Annals o Hematology(webposted Dec. 18, 2006) (DOI10.1007/s00277-006-0237-7). The patient died o ac-tive gastrointestinal tract and intracranial hemorrhage.

This death report may lend weight to the hypothesis thatmiepristone can produce excessive hemorrhage in somepatients.

72 In act, the FDAs Medical Ocer noted the resultso one methodologically poor but damaging study orRU-486. The Ocer observed that RU-486 abortionpatients experienced signicantly more blood loss thandid surgical patients. SeeSta Report, The FDA andRU-486: Lowering the Standard or Womens Health?

Hearing beore the Subcommittee on Criminal Justice,Drug Policy and Human Resources, Committee onGovernment Reorm, House o Representatives, Repre-

sentative Mark Souder, Chairman (October 2006): 14, n.68 (go to: ).

73 Raymond et al., 39. The prostaglandin used was geme-prost not misoprostol.

74 Ibid., 32.

75 Spitzet al., 1243.

76 FDA Miepristone Hearings Transcript, 223-7. Dr. MarkLouviere, M.D., told the panel at the 1996 FDA hearingo his encounter with a woman in his hospitals emer-gency room in November 1994. She had taken RU-486two weeks earlier and presented to the ER with hemo-globin equal to 5.8, hematocrit at 17.3, blood pressureat 90/60 and a pulse o 120. Ater receiving 2 units opacked red blood cells her hemoglobin level rose only to6.8, and she was given 2 more units. Louviere became

amous when he wrote a news story or the Des MoinesRegisterexposing blatant lying in a Planned Parenthoodpress release claiming no RU-486 complications in 238

women who took the drug in Iowa.

77 E. Hakim-Elahi, M.D., Letter to the Editor, Ob.GynNews(Feb. 15, 2005): 6.

78 Ibid.

79 Gardiner Harris, Some Doctors Voice Worry OverAbortion Pills Saety,New York Times(April 1, 2006).

80 Ibid.

81 Ibid.

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32

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politicized science the manipulated approval of ru-486 and its dangers to women's health

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