National Post

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Saturday, July 17, 1999

Jagged little pill changes the world of abortion
Ru-486: French drug likely coming to Canada after it reaches U.S.

Brad Evenson
National Post


The Associated Press
The French version of the RU-486 abortion drug

OTTAWA - She remembers only the small things. The endless flight of stairs to the clinic. The poster on the wall warning smoking can harm a fetus. The pill. "It tasted like chalk," she recalls.

She cannot remember the big things. How she found this particular doctor. What he said in the examining room. How she got pregnant -- "we were soooo careful." Her boyfriend's last name.

None of the memories of her misadventure in England last summer give her any pride. In fact, she still has recurrent dreams of a baby's face pressed against glass, like some haunted aquarium. But the 19-year-old Trent University student wakes up each day, free of anything but a muted sense of sadness. "Not regret," stresses Tessa, who wishes to keep her identity a secret.

"Taking the abortion pill was the only thing I can honestly say I did right."

Better known as RU-486, the little pill that has cut a jagged path across two continents could soon be coming to this country. Exelgyn, the Paris company that makes RU-486 and owns the Canadian patent rights, has steadfastly refused to market it to a country "where you kill people who do abortions." But some Canadian doctors who provide abortions suspect Exelgyn may relent before long.

Earlier this month, the company registered the drug in eight European Union countries, as well as Switzerland. It should be available for sale before the end of 1999.

"If they're allowing it in all of Europe, I suspect that [Exelgyn] are now not going to be so entrenched," says Dr. Ellen Wiebe, a Vancouver physician.

Furthermore, reports say RU-486 will be available in the United States by autumn, an arrival that will rattle the political landscape of abortion. Exelgyn spokeswoman Catherine Euvrard said on Friday the company will market the pill in Canada once it has arrived in the U.S. "Otherwise, you would have a lot of American tourists," she quipped.

If it comes to Canada, instead of only a few embattled clinics, family doctors across the country could offer medical abortions with relative anonymity.

It will probably not bring the shootings, bombings and weekly protests to an end. This, after all, is the medication the Pope deemed "the pill of Cain -- the monster that cynically kills its brothers." But the pill may embolden more doctors to offer a service that 70,000 women seek every year in Canada. Fewer than 5% of doctors now do abortions, but as many as 35% say they would be interested in prescribing RU-486.

Although most surgical abortions are not performed until the sixth week of pregnancy, women can take RU-486 any time in the first seven weeks.

Once a woman takes the pill, the chain of events cannot be stopped.

First, the drug blocks the hormone progesterone, which a fertilized egg requires to survive on the uterus wall. Two to three days later, she must insert four tablets of another medication called misoprostol into her vagina. This triggers contractions, causing the body to expel the uterine lining and the birth sac. In later weeks, this sac contains an embryo about the size of a dried pea.

None of this is painless.

In spite of arguments the drug will make abortion easier, the abortion rate in countries where RU-486 has become available --England, Sweden and France -- has not increased. Researchers say few women who have taken the pill consider it a casual procedure.

"I bled for a week afterward," says Tessa.

"My stomach felt like a twisting knot. I threw up constantly. It gives me nausea thinking about it. But every time I see an abortion protest on TV, or imagine those people waving those horrible fetus pictures in my face, I think, 'This was a better way.' "

Other women say they cannot bear the thought of instruments inside their wombs. "It seems less invasive to them," says Dr. Wiebe.

Such personal factors are what fuel the demand for RU-486, not medical concerns. Women over 35 and smokers are not advised to take it, following the 1991 death of a woman in France. The drug fails up to 5% of the time, requiring patients to have an emergency surgical abortion. In some cases, women using RU-486 have bled so profusely they needed blood transfusions.

"The follow-up is so important because it's not 100% effective," said Dr. Wiebe.

"If it's not effective, you could damage the fetus."

(Because of the fear of potential lawsuits and the need for follow-up visits, Dr. Wiebe believes most American doctors will not want to serve many Canadian patients, as they currently do when prescribing such drugs as Viagra.)

When the U.S. Food and Drug Administration swept aside any medical concerns in 1996 and declared RU-486 safe for use, all the pro-choice lobby needed was somebody willing to step forward and begin manufacturing the drug.

Of course, nothing in the drug's tortuous history has been quite so simple.

"This debate has been going on for nearly 20 years," sighs Marilyn Wilson, a spokeswoman with the Canadian Abortion Rights Action League.

Since its invention in France in 1982, the drug -- also known as mifepristone -- has been a scalding hot potato that few have wished to handle. In 1988, after a few turbulent years, the pharmaceutical company that owned the patent to RU-486, Roussel Uclaf SA, stopped selling the drug in France. It resumed only after the French health minister, Claude Evin, ordered the company to resume sales, calling RU-486 "the moral property of women." Today, roughly 25% of French women choose the drug over abortion by surgical aspiration.

However, Roussel's parent company, the giant German chemical firm Hoechst AG, was not anxious to sell the drug in the emotionally charged U.S. market out of fear it could damage the company's $6-billion in business there.

Opponents of abortion had already linked Hoechst's role in RU-486 production to its corporate history, when under the name I.G. Farben it manufactured Zyklon B, the gas used to exterminate Jews in the Nazi death camps. People have called the drug a "human pesticide."

In response, pro-choice groups began to pressure the U.S. government.

In 1992, a newly-elected Bill Clinton reversed a U.S. ban on RU-486 and pressured Hoechst into making the drug available. Instead, the company took an unusual step. In 1994, it donated the U.S. sales rights to a non-profit, New York-based organization called the Population Council.

Headed by a former Canadian health bureaucrat, Margaret Catley-Carlson, the Population Council is widely praised for its work promoting reproductive health. But it was sorely unprepared to run a drug company.

After being turned down by such major pharmaceutical companies as Johnson & Johnson, Abbott Laboratories and Merck, the council turned to a businessman named Joseph Pike to manufacture and market RU-486. But when news surfaced that Mr. Pike had been disbarred as a lawyer in North Carolina for forgery, the Population Council filed suit against him and turned to a small pharmaceutical company called the Danco Group.

Again, problems arose.

The Danco Group initially chose a Hungarian company called Gedeon Richter to synthesize the pill. But in 1997, the manufacturer decided not to go ahead. Again, lawsuits flew.

Several sources say the debacle left Ms. Catley-Carlson with little option but to resign.

"It was very unfortunate, because she was trying to do such good work, but things did not turn out well," according to Ms. Euvrard, who has frequent contact with the council.

Ms. Catley-Carlson could not be reached for comment this week.

Now Danco says it has found a group of laboratories willing to manufacture RU-486. A spokeswoman said the pill would be available by autumn, since the U.S. FDA has already given it safety approval.

To avoid the risk that doctors who prescribe RU-486 would be identified, Danco plans to ship it directly to their offices, sparing their patients the potential risk of a trip to the pharmacy.

Canadian doctors who offer abortions using the drug methotrexate already employ this technique, keeping their own stocks in their office dispensary. Curiously, while RU-486 has become a lightning rod for controversy, many women already opt for this lesser-known chemical technique. Given by needle, methotrexate "destabilizes" the placenta, which supplies nutrients and oxygen to the fetus, so the fetus stops growing.

Both methotrexate and RU-486 require some medical follow-up, and for this reason, up to 75% of women are likely to choose a surgical abortion, says Dr. Wiebe.

"They want to get it over with right away," she says.

If RU-486 is approved in Canada, it will almost certainly be covered by provincial drug plans, officials say. According to a source at the B.C. Ministry of Health, which has pushed strongly for the drug to be sold in Canada, "we think this would help a lot of young women overcome the emotional barriers that go with [abortion]."

Tessa would agree.

Now a volunteer with a charitable agency that counsels pregnant teens, she says abortion clinics offer safe medical service, but most young women would prefer to see their own doctors.

"Nobody wants to have an abortion," she says.

"But if you need one, [RU-486] is the best choice."

Copyright Southam Inc.