RU puzzled, fed up?

Dorothy Guellec

Last Thursday, September 28,2000, the landscape for abortion really changed. It has been a long time coming. The pill called RU-486 was developed in 1980. and in 1982 the first successful human testing was reported in France. After 10 long years of promises American women will surely benefit. “Finally, American women can benefit from this product,” said Edouard Sakiz, former head of the French drug company Roussel, which put the pill on the market in France. RU-486 is now widely available in Western Europe and even China, but 12 years after it appeared it is far from the method of choice in the countries where it is authorized, and it remains controversial in others. That being said 500,000 women have benefited from this non-invasive, private and relatively cheap method of inducing a mis-carriage, where the expelled matter would be the size of a grain of rice. It will probably cost $700 in the U.S. and some HMO's may not cover it. It is $66 in Spain and $200 in France fully reimbursed by their systems.

The history of RU-486 is a tortured one. In 1973 Roe v. Wade, followed by years of waiting until 1982 when Roussel Uclaf reported the first successful human testing. In 1983 the Population Council, set up almost 50 years ago by John D. Rockefeller III to address the problem of overpopulation, received the FDA approval to test the drug (mifepristone) in the U.S. During the next 6 years, more than 300 received RU 486 at the University of Southern California. September 1988 The French Health Ministry approved RU 486 combined with prostaglandin for medical abortion. The following month Roussel Uclaf suspended distribution because of pressure from antiabortion groups. After the Ministry ordered them back on the market the following year they became available. In May 1994 Roussel Uclaf donated the U.S. patent to the Population Council. In March 1996 the Population Council filed a new drug application with the FDA. February 1997 the Hungarian pharmaceutical company Geodeon Richter backed out of an agreement to make the drug.  April 9, 1997 Roussel UCLAF abandoned the pill to the researcher Edouard Sakiz for “zero franc zero centime.” The FDA approved the drug in September 2000. There is much more to the story but these details do not add very much.

The RU-486 3 pill regimen in my opinion is safer because it can be used within the first 49 days. In fact it can be used almost immediately after a woman discovers that her cycle is off. It is also non-surgical, private, and patients can avoid the emotional and psychological feelings associated with anti-abortionist zealots and their tactics that are often violent.

As to the ethical question that has plagued us for years, namely when does human life begin, there are many answers to that. Hospital ethicists define the beginning of life 1) at conception 2) at quickening or when the mother feels movement 3) when the unborn child is viable 4) at birth. Pro-life people do not subscribe to these definitions. For them life begins at conception which might be within 24 to 72 hours.

But survey after survey has found that most Americans (not so-called pro-life people) prefer early interventions and feel most comfortable with this idea. There is a sub-text to all this which may not emerge in the media. The very fact that horrible pictures no longer characterize abortions (with the use of RU-486 in early stages the embryo is barely the size of a grain of rice) will hopefully change the entire picture of abortion and wipe away both the stigma and guilt.

If one can believe the AP (Associated Press) they reported October 3rd “Health Insurers have generally agreed to cover the newly approved RU-486 abortion pill, according to a survey of leading managed care plans.” The price has not been set on Mifeprex (the brand name) though doctor visits and counseling are expected to run about $700. I would bet my life that this is cheaper at Planned Parenthood because they have a sliding scale. Covering new drugs is tricky and when the FDA approves a new drug there is a managed care review before deciding whether to cover it. This 3-pill regimen is different because it is dispensed directly from a physician's office and not through a pharmacy. Some managed care plans have decided to cover it and others are not sure as yet. It wouldn't be cool to try and second-guess their motives but I wouldn't rule out politics.

Is it a mere coincidence that 6 weeks before the Presidential elections RU-486 is approved and once again reappears on the horizon? Rhetorical question, bien sur but the political game continues infused with fresh blood (no pun intended). So 27 years after Roe v. Wade legalized it the U.S. remains the only so-called modern western country where the abortion question raises so much hatred and death threats.

I spoke with a CEO at Planned Parenthood for Westchester and Suffolk counties. She told me this morning (October 4th, 2000) that the pills would not be available before Thanksgiving, so other media reports of one month are really not valid at this time. In New Mexico Planned Parenthood said “about six months. In the meantime the FDA is trying to implement restrictions but The American College of Gynecologists and Obstetricians co-signed a letter written by the AMA last summer objecting to the restrictions, and requesting a meeting for July 24,2000. The letter said that restrictions imposed “inappropriate conditions on the practice of medicine and that the FDA has no authority to require such training for physicians who prescribe RU486.” If you go looking for this in the Federal Register or Congressional Record, there isn't much to be found, considering its “controversial” nature.

Right now it is too early to predict anything for sure. It seems that the total price will be the same as a so-called surgical AB (abortion) = for a long time = market power and the ability to affect prices = someone exerting power = OB/GYN types? Who knows? One cannot mysteriously have the price of the drug equal to the price of surgery.