Health Care: RU486,
Tested Locally, Shows
Pro-choice groups say the abortion-inducing drug RU486, which was trial-tested in San Diego in 1994, may hit the U.S. market by the end of March.
RU486, made by French drugmaker Roussel-Uclaf and approved for use in France in September 1988, was dubbed “approvable” by the U.S. Food and Drug Administration in 1996.
After a series of manufacturers backed out of the chance to market the drug, called mifepristone, in the United States, Roussel-Uclaf donated the rights to market it to the Population Council, a New York-based nonprofit research institution.
The New York-based pharmaceutical firm Danco Laboratories Inc. is the latest company to license the rights to manufacture mifepristone from the Population Council.
Mary Fjerstad, vice president of medical services at Planned Parenthood in Mission Valley, said her clinic conducted an eight-month, 300-patient trial with mifepristone combined with another drug six years ago.
The trial showed a 95 percent success rate in patients who took the drugs seven weeks following conception, she said.
“That mirrors the national findings,” she said.
The local study was part of a nationwide trial comprising 2,121 women in 17 sites.
Danco could not be reached for comment. However, Sandra Waldman, director of public information at the Population Council, said Danco and the council expect mifepristone to be approved within the next two months.
Labeling, Manufacturing Issues
The FDA is still in discussions with Danco and the council to resolve labeling and manufacturing issues, Waldman added.
Fjerstad said the approval of mifepristone marks a long-awaited alternative to a currently available, but less reliable medical abortion method , an injectable abortion-inducing drug called methotrexate.
Planned Parenthood’s anticipation that the drug will be approved soon prompted it to make plans for wide dissemination.
The nonprofit group plans to make mifepristone available at 123 centers in the nation within three months following approval. Within one year, 165 centers will use mifepristone, Planned Parenthood reported.
In San Diego, Fjerstad expects Planned Parenthood will make the drug available at most of its 12 centers.
She also expects mifepristone will likely replace methotrexate as the preferred choice of medical abortion.
Methotrexate, which has been approved by the FDA for treating arthritis, among others conditions, is less effective as an abortion-inducing drug than mifepristone, she said.
RU486 More Effective
Methotrexate has a 90 to 92 percent success rate within seven weeks of conception, Fjerstad said, significantly lower than the 95 percent success rate of mifepristone.
Methotrexate works as a one-time injection followed within two days by a vaginal suppository, called misoprostol, a prostaglandin that causes uterine contraction and shedding of the lining of the uterus.
The drug is problematic because it can take up to three weeks before an abortion occurs, Fjerstad said. According to her findings, about 50 percent of women abort the same day; 40 percent within one week.
Mifepristone, a one-time pill, is also followed up within two days with misoprostol, she said. Studies have shown that more than 50 percent of women using this method abort within four to six hours.
By the seventh day, 95 percent of women will have a complete abortion, Fjerstad explained.
Mifepristone can cause nausea and vomiting aside from the expected bleeding and cramping.
If medicinal abortion remains unsuccessful, surgical abortion will follow, Fjerstad said.
So far, about 2 percent of women seeking an abortion at Plant Parenthood chose the methotrexate method; 90 percent seek manual aspiration; 10 percent seek machine aspiration, Fjerstad said. The organization charges the same price for all methods, but Fjerstad declined to comment on costs.
Consumer Costs Still Unknown
The pricing of mifepristone will remain unknown until it is launched, but Fjerstad expects it’ll be higher than methotrexate.
She also expects that mifepristone , even though it can be taken in the privacy of one’s own home , will not replace surgical intervention.
“Most women prefer surgical abortion,” Fjerstad said. “You are two hours in a clinic and it’s done.”
Yet, the Kaiser Family Foundation estimated once RU486 is approved in the U.S., 50 percent of doctors who don’t provide abortion services will prescribe RU486.
Carlo Michelotti, chief executive officer at the California Pharmacists Association in Sacramento, and the association’s president, Christopher Woo, said it’s hard to say whether women would prefer the mifepristone method to surgical abortion.
Neither men offered to speculate on doctors’ choice once the drug becomes available. Either way, it’s a difficult topic, they said.
Other Methods Available
In the past, emergency contraception , the so-called morning-pill for which mifepristone would be approved , had created a crisis of conscience for some pharmacists who viewed it as a form of chemically induced abortion.
Pharmacy associations in Pennsylvania, New Jersey and other states reportedly had concerns about emergency drugs and the adoption of RU486 in the U.S.
At the California Pharmacists Association the issue hasn’t been heavily debated , yet.
Michelotti, a registered pharmacist, said it’s up to the individual pharmacists to decide whether they want to dispense the drug. He added, however, “the right to life groups try to paint the drug as the coming of the evil empire.”
The reality is that emergency methods, such as a mega-dose of oral contraceptives, have been around for a long time in the U.S., he said.
Planned Parenthood’s Fjerstad said a woman seeking either a medical or surgical abortion in San Diego doesn’t have to look far.
“She probably doesn’t have to drive more than 15 or 20 miles to get an abortion,” Fjerstad said.