Medical abortion options may advance in 1998
Look to 1998 for key developments in medical abortion for U.S. women, say those who are working toward that goal.
While details are being held close to vest, headway is being made on the following fronts:
• The New York City-based Population Council and its licensee, Advances/The NeoGen Group, is actively seeking companies around the world to manufacture mifepristone, says Council spokeswoman Sandra Waldman.
"We believe good progress is being made, and we continue to work with them to achieve Food and Drug Administration approval and introduction as quickly as possible," Waldman says.
• Mifepristone trials are under way in a number of U.S. cities as the New York City-based Abortion Rights Mobilization (ARM) studies the effectiveness of a 200 mg dosage of the drug. These trials will continue until there is a commercial product, reports project coordinator Eric Schaff, MD, associate professor of family medicine and clinical pediatrics in the Depart ment of Family Medicine at the University of Rochester (NY).
• Twenty-nine Planned Parenthood affiliates are actively recruiting women for its study of methotrexate and misoprostol, with information tentatively scheduled for publication next summer, says Michael Burnhill, MD, vice president for medical affairs for Planned Parenthood Federation of America in New York City.
"We will be publishing a detailed analysis that is first going to see daylight next July," he says.
No matter which drug regimen becomes available first, medical abortions with mifepristone or methotrexate, when combined with a prostaglandin, are now established as safe and effective, observes David Grimes, MD, in an article published in Obstetrics & Gynecology.1 Grimes, professor and vice chairman of the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of California, San Francisco, substantiates this claim with a review of all studies of medical abortions that included more than 100 women. Because of its technical simplicity, such drug regimens should enlarge the pool of abortion providers, he concludes.
Such an expansion in the provider pool may offset a trend of decreased access to abortion services. As of 1992, only 16% of U.S. counties had an abortion provider.2
Twists and turns slow drug debut
Mifepristone appeared to be on track for U.S. distribution after clearing legal wranglings with a California businessman (see Contraceptive Technology Update January 1997, p. 11, and April 1997, p. 51). However, it suffered a major blow in June when Hungarian pharmaceutical firm Gedeon Richter withdrew from its agreement with the Population Council and American distributor San Diego-based Danco Laboratories to manufacture the drug. (For more information, see CTU, August 1997, p. 103.) A lawsuit against Gedeon Richter is still ongoing, says Waldman.
"The basic message is that our licensee is trying to get the manufacturing end of this tied up so we can proceed with the FDA process," says Waldman.
While the quest continues for market availability of mifepristone, women in Rochester, NY; New York City; Burlington, VT; San Francisco; Atlanta; Seattle; and cities in Montana, Nebraska, and Maryland are participating in clinical trials of the drug conducted by ARM, says Schaff. Plans for a trial site in Dallas are pending, and two more sites in New York City are being recruited, he reports.
A total of 1,400 subjects have been recruited to date for the trial, with the protocol calling for 200 mg of mifepristone. The standard dosage in Europe is 600 mg of mifepristone, but the current U.S. trial shows more than 95% effectiveness with the lower dosage, says Schaff.
"We are now studying women up to 9 weeks gestation," says the physician. "Ninety percent of subjects find the process acceptable. Patients are recruited by referrals, yellow pages, and word of mouth."
Carolyn Westhoff, MD, MSc, associate professor in the Department of Obstetrics and Gynecology and School of Public Health Epidemiology at Columbia University in New York City, also is participating in the ARM studies. Westhoff spoke in support of mifepristone on behalf of the Washington, DC-based American College of Obstetricians and Gynecologists during the 1996 Food and Drug Administration hearing on the drug.
"I’m very pleased to be able to study this and to be able to offer it to women," she notes.
Planned Parenthood’s objective is to continue its trial of methotrexate/misoprostol into 1998 to prepare what will be the largest multicenter trial of the regimen, says Burnhill.
"At the present moment, all I can say is that we have recruited over a thousand women, and we haven’t had any serious complications," he notes. "The study is ongoing."
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