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Pro-choice forces have succeeded in stopping a Congressional provision that would have prevented Food and Drug Administration approval of mifepristone. Last June the U.S. House of Representatives voted to amend the House Agricultural Appropriations bill to include a provision prohibiting the use of funds by the FDA for the "testing, development, or approval (including approval of production, manufacturing, or distribution) of any drug for the chemical inducement of abortion." This amendment, introduced by Representative Tom Coburn (R-OK), would have derailed mifepristone approval and would have been the first time that Congress had dictated to the FDA which drugs it could and could not approve. On September 28, the majority of Senators on the joint Conference Committee negotiating differences between House and Senate versions of the agricultural appropriations committee stood firm against the anti-RU 486 provision. By October 2, Coburn withdrew his amendment because of the Senate's strong position and concerns about a certain presidential veto. Eleanor Smeal, President of the Feminist Majority, stated, "Anti-abortion leaders in Congress have failed in their last ditch effort to block the availability of mifepristone in the United States. However, this outrageous attempt to limit the FDA's ability to review new drugs exposes the true extremism of the anti-abortion movement. Hopefully, we have overcome the last political hurdle to the long-awaited introduction of mifepristone in this country. Now, we must continue to work to make sure this safe, effective method of early abortion becomes available here as soon as possible and that trials on its many possible medical uses move forward." Mifepristone has shown promise in the treatment of endometriosis, meningiomas, the most common brain tumor, some types of breast cancer, uterine fibroids, and Cushing's syndrome. Yet because mifepristone is not yet available in the U.S., few of the victims of these serious illnesses has access to the drug. Mifepristone also can be used as an emergency contraceptive and as a method of labor induction. A veto message from President Clinton clearly was critical to stopping the Coburn provision. Also key to defeat of the anti-RU 486 amendment were Senate Conferees Dale Bumpers (D-AR), Barbara Boxer (D-CA), Tom Harkin (D-IA), Patrick Leahy (D-VT), Herbert Kohl (D-WI), Robert Byrd (D-WV), Arlen Specter (D-PA), and Slade Gorton (R-WA) who refused to accept the House provision and Congresswoman Rosa DeLauro who led efforts on the House side to prevent the amendment from emerging from the Conference Committee. The Feminist Majority, along with Planned Parenthood Federation of America and the NARAL, galvanized the scientific and medical community to oppose the Coburn Amendment. The American Medical Association, American College of Obstetrics and Gynecology, American Psychological Association, American Women's Medical Association, Endocrine Society, and the National Association of Nurse Practitioners were among the organizations which signed a letter to Congress against the measure. Moved by concerns that the Coburn Amendment would further hinder testing and availability of mifepristone and other drugs for non-abortion uses as well, cancer organizations and women who may benefit from access to mifepristone for the treatment of other diseases organized against the anti-RU 486 provision. Abbie Sheloush and her daughter Lea, who has endometriosis and has tried for two years to gain access to the medication, sent letters urging Congress to oppose the Coburn Amendment. Studies have shown that as little as 5 milligrams mifepristone helps relieve the pain associated with endometriosis, and that 50 milligrams controls pain and decreases endometriotic implants. Recently published data from U.S. trials conducted by the Population Council, which owns the U.S. patent rights to mifepristone, show that women in the U.S. who used mifepristone are overwhelmingly in favor of the drug: 96% of women said they would recommend mifepristone to others, and 91% would choose it again. Even among women who did not successfully complete the abortion using mifepristone, most would recommend the drug to a friend. Two-thirds of the women felt their experience with mifepristone was better than they expected. The Population Council trials showed that 92% of women using mifepristone within the first 49 days of conception successfully had an abortion. These are similar to the results of the French trials, which had a 95% success rate. Increased provider experience is expected to increase the rate of success of mifepristone. The trials also found that the drug was safely administered in the U.S. setting involving a variety of clinic locations and a mix of economic and ethnic backgrounds among trial participants. All side effects were the same as those experienced by women in other countries, and are similar to a natural miscarriage, including bleeding, cramping, and nausea. The Population Council's commercial partner, the Danco Group, has arranged for the manufacture of mifepristone and is completing the necessary requirements for final approval by the FDA. Mifepristone could be available in the U.S. as early as next year. Mifepristone is currently available to women in France, Great Britain, and Sweden, and has been used by hundreds of thousands of women worldwide as a safe and effective form of early abortion. The drug will soon be available more widely because the worldwide patent rights (excluding the U.S.) are now owned by Dr. Edouard Sakiz, who developed the drug. Abortion Rights Mobilization is currently conducting the only U.S. early abortion trials on mifepristone, giving American women limited access to the drug. See side bar for clinic locations and phone numbers. Larry Lader, President of Abortion Rights Mobilization, is using privately-produced mifepristone pills for the trials. "Because we don't own the patent to mifepristone, we received an Investigative New Drug letter from the FDA which allows us to test the drug as long as we do not sell the pills," said Lader. "We will try to keep the trials going until mifepristone is on the market." Already 2,500 women have participated in the ARM trials, and Lader is hoping to add more clinics in order to treat at least 10,000 women. Mifepristone is currently available to U.S. women at the following Abortion Rights Mobilization trials sites:
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