By Cynthia L. Cooper<br />WeNews correspondent” align=”right”/></p>
<p><P>(WOMENSENEWS)–Broke, laid off from her job, without health insurance, and five weeks pregnant, Seattle resident Lee Knowlen understood with exceptional clarity what it meant to swallow the pills that the doctor handed to her.</P><P>“I was in no position to have a baby; there was no way,” said Knowlen (not her real name).</P><P>“Medicine is usually something done to us. But I,” and Knowlen emphasizes the ‘I,’ “I wastaking those pills. I took an active role in myabortion. It’s a lot more private. But it’s not something for everyone.”</P><P>The pills were RU-486 or mifepristone. Knowlen took them as part of the U.S. clinical trials that were conducted in 1996 to show that nonsurgial abortions are safe and effective. </P><P>Mifepristone blocks the hormone progesterone, which is necessary to sustain a pregnancy. Doctors prescribe the it in combination with another pill, misoprostol, which is taken two days later. The regimen causes a woman’s body to expel the fetal tissue, similar to a miscarriage. Common side effects include cramping and bleeding. </P><P>The U.S. Food and Drug Administration approved the pills in September 2000. Under the brand name Mifeprex, the pills are distributed by the New York-based Danco Laboratories LLC and sold only to doctors or other clinicians who are trained in their usage. They are now available through doctors’ offices or clinics in every state.</P><P>Since 2000, 280,000 women in the United States have made the same choice as Knowlen to have nonsurgical abortions in the first seven to nine weeks of pregnancy.</P><P>In the past few months, however, that choice has come under renewed attack by foes of RU-486, some of whom also successfully pressured the FDA to decide in early May to withhold approval for the over-the-counter sales of Plan B, the so-called emergency contraception or morning-after birth control pills.</P><P>The anti-choice American Association of Pro Life Obstetricians and Gynecologists wrote to the FDA on April 1, 2004, demanding that it “devote agency attention immediately” to “repeal of the approval of mifepristone (Mifeprex).” </P><P>In May, Concerned Women for America and the Christian Medical Association released a flurry of press releases and other published statements decrying the “profiteers” who support the abortion pill. </P><P>These groups would like to see the FDA suspend the approval of Mifeprex and return women to the days when surgery is the only option for women who choose to have an abortion. </P><P>In a counter move, the National Abortion Federation and Planned Parenthood Federation of America on May 20 filed a document with the FDA detailing the history, medical practice and safe track record of Mifeprex and called upon the FDA to reject attempts to withdraw the product. </P></p>
<h2>Charges of Hasty Approval</h2>
<p><P>Dr. Gene Rudd, associate executive director of the Christian Medical Association, said in an interview with Women’s eNews that the FDA acted hastily in its initial approval mifepristone.</P><P>Although Rudd opposes abortion of any sort, he said his only concern is for women’s care. A surgical abortion, he said, “only takes 10-to-15 minutes and is safe.” Given that, he doesn’t see why women need an option that involves bleeding and the passage of tissue. “I’d love to hear why this is a better choice,” he said</P><P>Mifepristone advocates, however, say the nonsurgical option is low risk and one that many women prefer. Planned Parenthood reports that, nationwide, 20 percent of its first-trimester abortion patients chose Mifeprex in 2003.</P><P>“There is nothing that has happened in the three years of having mifepristone on the market that shows it acts differently or is any more dangerous than when it was approved,” said Dr. Beverly Winikoff, an early researcher of mifepristone who is now president of Gynuity Health Projects, a research organization in New York. “An unpoliticized FDA would not see any reason to change the status of the drug. But, as we’ve seen, politics can trump everything.”</P></p>
<h2>Congressional Bill in Subcommittee</h2>
<p><P>In November 2003 the push to roll back availability of mifepristone turned legislative, as U.S. representatives Jim DeMint (R-SC) and Roscoe Bartlett (R-MD) introduced a bill–now in a health subcommittee–to suspend approval of mifepristone. </P><P>They call it “Holly’s Law” after Holly Patterson, an 18-year-old California woman who died of a severe infection one week after taking mifepristone in September 2003. </P><P>In December 2003, Danco, the drug’s distributor, released a statement saying “Childbirth, menstruation and abortion (whether spontaneous, surgical or medical) all create conditions that can result in infection, as appears to have happened in this case. There is no medical evidence that Mifeprex and misoprostol present a special risk of infection.”</P><P>Planned Parenthood clinics reported infections severe enough to require hospitalization in 7 of 43,153 cases in 2003, a small fraction of 1 percent of the users. </P><P>In addition, backers of the non-surgical abortion agent contest Rudd’s charges of hasty approval. They say the push against mifepristone is part of an effort to subordinate the scientific work of the FDA to anti-choice pressure groups.</P><P>“There is concern that the Bush administration ignores scientific and medical evidence and bases decisions strictly on politics,” said Vicki Saporta, president and chief executive officer of the National Abortion Federation. “Mifeprex approval was based on scientific evidence and research and there is no reason to remove or rescind its approval.”</P></p>
<h2>Adolescent Risks Raised</h2>
<p><P>Among other arguments against mifepristone, the groups assert that the FDA inappropriately failed to require clinical testing of mifepristone in an adolescent population when the drug was initially approved.</P><P>The FDA specifically addressed this issue when it approved mifepristone, saying “there is no biological reason to expect menstruating females under age 18 to have a different physiological outcome with the regimen.”</P><P>Raising the specter of adolescent health risks is the same tactic that ultimately prevailed in the case of Plan B, a product that is often confused with RU-486.</P><P>Unlike Mifeprex, which ends an early pregnancy, Plan B, known as “emergency contraception” or “morning-after” pills, consists of high-dose birth control pills that can be taken up to 72 hours after intercourse to prevent the establishment of a pregnancy. </P></p>
<h2>Longstanding Opposition</h2>
<p><P>The campaign against RU-486 is longstanding and, according to reproductive-rights activists, has helped propel some opponents of the drug into the FDA.</P><P>In 1991, Christian Medical Association, based in Bristol, Tenn., passed a resolution calling mifepristone morally unacceptable. </P><P>“We believe it violates the biblical principle of the sanctity of human life . . . The apparent ease and simplicity of pharmacological abortion further trivializes the value of life.” </P><P>In 2002, Concerned Women for America, the Christian Medical Association and the American Association of Pro Life Obstetricians and Gynecologists filed a still-pending petition to the FDA, asking for revocation of the approval of Mifeprex.</P><P>In December 2002, President George W. Bush appointed Christian Medical Association member Dr. W. David Hager to the FDA committee with oversight of mifepristone, despite a massive e-mail petition opposing the appointment.</P><P><I>Cynthia L. Cooper is an independent journalist in New York City who writes frequently about legal issues and reproductive rights.</I></P> <P>Women’s eNews welcomes your comments. E-mail us at <a href=[email protected].