RU-486: Killer Pills

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The FDA broke its own rules in the fast-track approval of the “abortion pill.” Sadly, women are paying with their lives. Most people assume that advances made in medicine and science are helpful—and save lives. Regrettably, that is not always true. In the case of the abortion pill, RU-486, women are not helped—and lives are certainly not saved. Yet in September of 2000, the Food and Drug Administration (FDA) approved RU-486, or Mifeprex, for sale in the United States—a drug whose only purpose is to kill human beings. POLITICS AND CONTROVERSY


      There are reasons this chemical abortion is controversial. In 1993,       President Bill Clinton overturned the ban on RU-486. He ordered the U.S.       Department of Health and Human Services (HHS) to review ways to test,       license, and manufacture the drug. HHS Secretary Donna Shalala compelled       Roussel-Uclaf, the French manufacturer of RU-486, to hand the patent       over—for free—to the Population Council, a pro-abortion group. The       Population Council used intense political pressure on the FDA to approve       the drug without the necessary testing or restrictions to ensure patients’


       The Population Council created Danco Laboratories to market and distribute       RU-486. Danco could not find a company in the United States willing to       manufacture the drug, due to the risk that healthy women would be injured       or have children born with abnormalities. So it contracted with a company       in China, which was previously cited by the FDA for tainted drugs.


      HOW RU-486 WORKS


      In their campaign to promote RU-486, pro-abortion activists claimed that       RU-486 makes abortion “easier,” “safer” and “more private.” But there is       nothing easy or safe about RU-486.


      The FDA limits RU-486 to women in the first seven weeks of pregnancy.       After taking three tablets in the abortion facility or doctor’s office,       the woman goes home. This drug blocks progesterone from getting to the       developing baby. Without this nutrient hormone, the baby starves to death.

      Thirty-six to 48 hours later, the woman returns to the doctor to take a       second drug, misoprostol, to expel the baby. Misoprostol is an ulcer drug       that the manufacturer, Searle, has warned doctors should not be used in       pregnancy-related conditions. It is at this time that the woman is most       likely to suffer complications.

      Seven days later, she returns for an exam to make sure the baby has been       expelled and to monitor her bleeding. If the procedure failed, the woman       then undergoes a surgical abortion.

      The procedure requires three clinical visits and access to emergency       medical facilities in the event of complications.


      Women who take RU-486 experience firsthand just how difficult it is.       Common side effects include painful contractions, nausea, vomiting,       diarrhea, pelvic pain and spasms, dizziness and headaches—as well as the       trauma of potentially seeing their aborted baby. Some women have been       hospitalized and required surgery and/or a blood transfusion. In most       cases, women endured prolonged bleeding, anywhere from nine to 30 days.

      It is not known what the potential long-term side effects might be on a       woman’s fertility, future pregnancies or immune system.

      Since its approval, one woman died from a ruptured ectopic pregnancy. Two       15-year old girls suffered life-threatening infections. One 21-year-old       had a heart attack. A woman in Canada died during the trials from       bacterial infection, which caused the trials to be suspended. These were       healthy women, who, after taking RU-486, ended up very unhealthy.

      Edouard Sakiz, former president of Roussel-Uclaf, described RU-486 as “not       at all easy to use.” He explained, “The woman must live with this for a       full week; this is an appalling psychological ordeal.”


      In June of 2000, the FDA notified the Population Council of the various       restrictions under which RU-486 would be approved—all intended to ensure       the safety of the patient. These restrictions reflected the limitations       used in the trials and how it is used in Europe. For example, ultrasound       must be used to determine the age and place of pregnancy, since the       complication rate for RU-486 increases dramatically if used after 7 weeks,       and it does nothing to treat an ectopic pregnancy, which has the same       symptoms as common RU-486 side effects—pain and bleeding.

      The Population Council leaked the list of restrictions to pro-abortion       groups and the media. The groups complained publicly and to the FDA that       the restrictions would limit the accessibility of the drug. Newspapers ran       editorials criticizing the FDA. The FDA buckled and dropped nearly all the       guidelines intended to protect patients.

      The remaining restrictions were weakened. For example, no longer could       only physicians trained in dating pregnancies, managing complications or       performing surgical abortions as a backup be allowed to administer RU-486.       Instead, FDA allows RU-486 to be “provided by or under the supervision of       a physician.” No qualifications were established as to who can work “under       the supervision of a physician.”


      Concerned Women for America, along with the American Association of       Pro-Life Obstetricians and Gynecologists and the Christian Medical       Association, filed a Citizen Petition with the FDA on August 20, 2002.       This legal document outlines the numerous violations the FDA committed in       its approval of RU-486 and how these violations resulted in the injury and       death of women.        RU-486 was approved under a special “restricted distribution” approval

        process known as “Subpart H,” reserved only for drugs that treat

          “severe or life-threatening illnesses.” Even the Population Council

        complained that approval under this provision was “unlawful, unnecessary

        and undesirable.” Pregnancy is not a severe or life-threatening illness.         Other drugs approved under Subpart H treat fatal diseases, such as         cancer or AIDS, and can have serious side effects —considered acceptable         when the alternative is death. However, Subpart H allows the FDA to         retain the right to oversee the drug’s use after approval, and the right         to pull the drug if it proves too dangerous or the manufacturer allows

        the drug to be used improperly.

         The clinical trials to test the safety and efficacy of RU-486 were         seriously defective. Neither the French nor the U.S. trials met FDA’s         standards. The data from the French trials suggest fraud, evidence         tampering and under-reporting of complications. No data from the U.S. or         French trials were obtained from blind testing, from randomized tests or         from comparisons with control groups—FDA requirements to ensure unbiased         trials. Yet even these biased trials are not reassuring about the safety         or efficacy of this drug: 99 percent of the U.S. test subjects suffered         some adverse event, and 23 percent of those were considered serious.

        Abortion was complete in only 92 percent of the test cases.


        Nearly all the safety precautions the FDA recommended to protect

          women from being injured or killed by RU-486 were dropped from the

          final approval. These precautions included ultrasound diagnosis to verify the         age and location of the pregnancy, and that the prescribing physician be         able to treat an incomplete abortion and to have admitting privileges at         a nearby hospital. These are all lower safety standards than required in

        other countries where RU-486 is used.


        FDA ordered that a second drug, misoprostol, be used in conjunction

          with RU-486, since RU-486 is not effective in completing an abortion

        alone. However, misoprostol is an ulcer medication and its manufacturer,

        Searle Laboratories, warned doctors it does not want it used for abortion.

        The FDA has, in effect, mandated an unapproved “off-label” use of a drug, an         action that is utterly without precedent or legal authority.


        The FDA waived the “pediatric rule” with no explanation. Any drug given         to adolescents must be tested on adolescents. Teenagers’ bodies go         through rapid hormonal maturation; their bodies are different from         adults. No one under 18 (or over 35) was allowed to participate in the         RU-486 clinical trials. Other countries have the same age restrictions.         Yet the FDA did not limit the age of females to whom RU-486 could be         given. Such prominent liberals as Sen. Hillary Rodham Clinton (D-New         York) and Rep. Henry Waxman (D-California) have avidly championed the         enforcement of the “pediatric rule” because they fear that         pharmaceutical companies might endanger the health of children by         cutting corners in the clinical trials.

        Complications reported to the FDA demonstrate that RU-486 is a

        serious threat to the health and safety of women. These include two

        fatalities and 20 other near-fatal complications including a heart attack, two         cases of systemic bacterial infection in 15-year olds and several         hospitalizations for hemorrhaging. The FDA and Danco sent a letter to         physicians in April 2002 warning of the complications reported since the         FDA approved RU-486. This alone would cause an ordinary drug to be

        removed from the market immediately.

         Danco, the distributor of RU-486, has a legal obligation to ensure that

        the drug be administered only in accord with the procedures approved

          by the FDA. Yet there are abortion providers who are advertising that they         will administer RU-486 up to nine weeks of gestation (instead of the         seven-week limit set by the FDA) and who have patients self-administer         misoprostol, the second drug, at home. It is obvious that Danco is

        failing to live up to its post-approval obligations.


      The Citizen Petition and related documents can be found at



       Abortion is a difficult, traumatizing procedure that has ended the lives       of millions of children and scarred the women who endured it. Chemical       abortions like RU-486 will not advance women’s health. They will only

      advance our national tragedy of abortion.

       The FDA violated its own safety regulations when it approved RU-486 and       put women’s lives and health at risk. To protect further women from being

      harmed, it must pull its approval for Mifeprex.

       Wendy Wright is senior policy director for Concerned Women for America.       Michael Schwartz and Marian Wallace contributed to the writing of this       paper. Used with permission.        Concerned Women for America       1015 Fifteenth St. N.W., Suite 1100       Washington, D.C. 20005       Phone: (202) 488-7000       Fax: (202) 488-0806       E-mail: