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Legislator-physician's last-minute amendment blocks FDA
BY Joseph Esposito
WASHINGTON—Pro-life forces scored a major congressional victory in the fight against the abortion pill RU-486 June 24. The House of Representatives adopted an amendment to the agriculture appropriations bill that would prevent the Food and Drug Administration (FDA) from proceeding with activities related to the drug.
The amendment, offered by Rep. Tom Coburn (R-Okla.), stipulates that no federal money would be made available to the FDA “for testing, development, or approval (including approval of production, manufacturing, or distribution) of any drug for the chemical inducement of abortion.” The initiative passed by a 223-202 vote.
Coburn, a practicing physician, said, “The federal government has no right to use taxpayer dollars to develop abortion drugs. We should be seeking alternatives to abortion rather than making abortion more accessible. This amendment helps this Administration keep one of its promises to make abortion rare.”
“The business of the FDA is to protect lives, not to facilitate death. Preserving consumer safety is the proper mission of the FDA. However, the FDA's practice of developing and approving abortion drugs helps kill unborn children and threatens the health of women,” he added.
According to Michael Schwartz, an aide to Coburn, the legislative strategy is to bypass the introduction of a similar amendment in the Senate. After conflicting versions of the appropriations bill are passed, it is then hoped that the House-Senate conference committee would approve a bill containing the Coburn language. If the resulting conference report is passed by both houses, it would then go to President Clinton for action.
Such efforts are likely to take place in September, after the summer congressional recess. The 1998-99 fiscal year for the federal government begins Oct. 1, so action needs to be taken before then. It is possible that the president, who has consistently supported pro-abortion measures, could veto a bill banning RU-486. A veto, should it occur, would come directly before the congressional elections and might be a political issue in some districts.
For now, however, pro-life supporters are enjoying what is an unexpected victory.
Helen AlvarÈ, director of planning and information for the National Conference of Catholic Bishops Pro-Life Secretariat, told the Register: “We're absolutely delighted and somewhat surprised. We knew only a day or so in advance that [Coburn] was going to introduce it. It went through pretty easily. It was a sign of hope to us that this drug, which is being sold as having the ability to make abortion even easier to get than it is now, could possibly be stopped.”
Philip Gray of Catholics United for the Faith, a Steubenville, Ohio-based lay apostolate organization, said, “We are encouraged by the efforts of the members of the House in their passing a bill prohibiting the use of the drug. Their efforts reflect support for married love, families, and the right to life. We pray the Senate and President Clinton will have the grace and courage to support these principles in their review of the bill.”
Although RU-486 (also known as mifepri-stone) is not now available in the United States, it has been used in France, Great Britain, and Sweden during the past decade. The drug, which was developed by French Dr. Etienne-Emile Baulieu, has been used to abort 200,000 children in Europe.
The drug traces its pharmaceutical company lineage to the infamous Zyklon B (cyanide) used in the gas chambers of Nazi concentration camps. Zyklon's manufacturer, the German firm I.G. Farben, was taken over by Hoechst AG, a large Swiss drug maker that has been the driving force behind RU-486.
The French drug company Roussel Uclaf, now allied with Hoescht, introduced RU-486 in France in 1988. Various U.S. pro-life organizations, including the National Right to Life Committee, launched boycotts of various products of Roussel Uclaf, Hoescht and, later, the merged firm of Hoechst Marion Roussel. The intent was to encourage the company to cease manufacturing the drug and to discourage entry into the large U.S. market.
The boycott began in 1994 and has included antihistamines Seldane and Allegra and a number of other drugs such as Topicort and Claforan. The boycott accounted for an 8% decline in U.S. sales for the portion of the year it was in effect in 1994 and a 16% decline for the full year of 1995.
To stem the negative publicity and the boycott, Hoescht Marion Roussel sought to disassociate itself from RU-486. Certain rights were given to a former Roussel official, Dr. Edouard Sakiz, and U.S. rights were “donated” to the Population Council, a pro-abortion organization based in New York City.
On Jan. 22, 1993, two days after taking office, Clinton directed the U.S. Department of Health and Human Services (HHS) to begin testing and evaluating the use of RU-486 in the United States. This action, taking place on the 20th anniversary of the Roe v. Wade decision, was referred to in an HHS news release—apparently with pride—as “one of [Clinton's] first official acts” as president.
Donna Shalala, secretary of Heath and Human Services, announced in May 1994 that U.S. rights were being transferred to the Population Council. At this point, Hoescht Marion Roussel tried publicly to wash its hands of the controversy. The company stated, “The transfer of Roussel Uclaf's rights to mifepristone [RU 486] is final and legally binding. Hoescht and its subsidiaries no longer own these rights.”
Exactly one year ago, in July 1997, a Food and Drug Administration (FDA) advisory committee recommended that RU-486 be approved in the United States. The process was relatively swift. Dr. Wanda Franz, president of the National Right to Life Committee, said at the time, “The FDAapproval process is moving at an unheard of pace to approve this deadly drug combination, leaving many concerns about safety unresolved.”
Dr. John Willke, president of Life Issues Institute and a leading expert on RU-486, contends that the FDA's endorsement is based on political, not medical considerations.
“Under normal circumstances,” he said, “it wouldn't have a ghost of a chance for approval.”
Americans United for Life (AUL), headquartered in Chicago, agreed. They told their membership in 1995, “Don't let the FDA put pro-abortion politics over science and medical safety.”
AULfiled a voluminous citizens petition with the FDA, detailing the medical consequences of the use of RU-486 and urging its disapproval.
The petition identified such side effects as cramping, pelvic pain, heart problems, extensive bleeding, and other problems.
U.S. tests seem to have affirmed the AUL's position and suggest the prudence of banning the chemical. In September 1996 the Family Research Council reported the following: “During the U.S. clinical trials earlier this year, four women required blood transfusions because they lost so much blood, 15 women required surgery, 21 required hospitalization, 13% required treatment for bleeding, and 5% of all women in the study required narcotics for the pain.”
The report continued: “All of these side effects happened in spite of the fact that the women who participated in the clinical trials were highly motivated, closely monitored, and underwent follow-up. We can expect that women will suffer results far worse that these when RU-486 becomes available to all U.S. women without the ideal conditions associated with clinical trials.”
Another serious concern associated with the RU-486 and a second chemical abortion pill, misoprostol, is the need to have a number of clinical visits to accomplish the objective of abortion. RU-486, for example, is the first step. It is taken between the fourth and seventh week of pregnancy.
To enhance—though not ensure—the likelihood of abortion, prostaglandin injections then are needed to expel the fetus. Sometimes several injections are required and ultrasounds are used to check the status of the pregnancy. Without proper follow-up procedures, which often don't take place, women are at considerable risk. In addition, the abortion may be unsuccessful, and pregnancies may continue with severely malformed children.
The May 30, 1998 issue of The Lancet, a British medical journal, published results of a study on the use of the prostaglandin drug misoprostol in unsuccessful RU-486 abortions. The research examined 42 children who were subjected to the drug during 1992-1997. The extent of deformities is significant: 27-30 of them had a clubfoot; 21 had cranial nerve defects with some degree of facial paralysis; 13 had deformed fingers or toes; eight had hydrocephalus or “water on the brain”; five had unusually small heads; and others had stunted muscle or bone development.
Dr. Claudette Gonzalez, who conducted the study, was quoted in a May 29 Reuters wire service story: “We hope that greater awareness of the widespread use of misoprostol to induce abortions will lead to new public-health measures to prevent these tragic consequences.”
The action taken by the House of Representatives is an effort in the direction of ending such tragedies. Pro-life advocates pledge to urge lawmakers to render judgments on such abortifacients based on rationality, not politics.
Gracie Hsu, a policy analyst on pro-life issues for the Family Research Council, said, “Indeed, we would all be outraged if the federal government ever issued an approval of Dr. Kevorkian's killing machine simply because he claims there are ‘therapeutic’ effects for his patient.
“We know otherwise. In the same way, the federal government should not give its imprimatur to RU-486 because no government should ever be responsible for the killing of innocent human beings or an accomplice to the mothers who would take the lives of their own children.”
Joseph Esposito writes from Springfield, Virginia.