National Post

Page URL: http://www.nationalpost.com/home.asp?f=990717/31324

Saturday, July 17, 1999

Abortion pill headed for Canada
Called 'human pesticide': Company feared country where 'you kill people who do abortions'

Brad Evenson
National Post

OTTAWA - The controversial French abortion pill RU-486, which allows a woman to induce a termination as early as the day after conception, could be available in Canada within six months, says an official with the Paris-based company that manufactures the drug.

Until now, Exelgyn has refused to sell the pill in Canada, a country where, it contends, "you kill people who do abortions."

But now that another manufacturer has announced it will release the pill in the U.S. in October, Exelgyn has changed its mind about selling it in Canada. "As soon as [RU-486] is launched on the U.S. market, we will apply for registration, but not before," said Catherine Euvrard, an Exelgyn spokeswoman. "It would be very difficult to have it in Canada and not in the United States."

The abortion pill has sparked worldwide protests since it was developed in France in 1982. In Germany and Spain, anti-abortion groups have organized boycotts and protests. This week, the Roman Catholic Church condemned its use, and American opponents have termed it a "human pesticide."

Also known as mifepristone, RU-486 will dramatically change the way women obtain abortions.

Unlike surgical abortions, which are not usually performed before the sixth week of pregnancy, a woman can take RU-486 the moment she learns she's pregnant until the seventh week. Using sophisticated new home-pregnancy tests, it is possible to confirm a pregnancy after only a week. Anti-abortion groups fear that the drug may be used as a routine method of contraception, however.

The method could improve access to abortions across Canada and is far less invasive than the surgical procedure most commonly used.

Most Canadian doctors do not perform surgical abortions because they fear being a target of anti-abortion activists. Since 1994, four doctors in Canada and one in upstate New York have been shot by snipers. Abortion clinics are also frequent targets of bombs and demonstrations.

But with RU-486, women seeking early abortions could get the pill from their own obstetrician, gynaecologist or their family doctor.

More coverage, Page B1

Protesters would find it more difficult to choose targets.

See DRUG on A2

"It will not end the debate, but it will shift it," said Marilyn Wilson, a spokeswoman for the Canadian Abortion Rights Action League.

Women's groups have lobbied for more than 10 years to get RU-486 released in Canada.

However, Hoechst AG, the German chemical giant that owned the patent rights, refused to sell the drug outside of France for fear of a consumer backlash. In 1994, it relinquished the U.S. rights to a New York-based organization called the Population Council, which after a long series of setbacks is bringing the product to market this fall.

Exelgyn, a private company owned by one of RU-486's inventors, now holds the world rights.

The company has withheld the drug from Canada for years, saying it feels Ottawa has been cool to its introduction.

"We have repeated many times that we would appreciate receiving a kind of message of support from your federal government, but we have never got it," said Ms. Euvrard.

"We feel that they are not very excited about the idea of having [RU-486] on their market."

Officials in Health Minister Allan Rock's office say federal regulations prevent it from issuing such a statement, since it would put political pressure on Canada's drug approval process.

There's been no shortage of political pressure. In 1996, the B.C. government sought to fund clinical trials of the drug in Vancouver, and pushed Ottawa to make RU-486 a priority. Similarly, the Canadian Medical Association, the Society of Obstetricians and Gynecologists of Canada and various women's groups have publicly called for the release of RU-486 for testing.

Now, it appears Exelgyn is on a worldwide market expansion.

Beginning on July 6, the company registered with health authorities in eight European Union countries, as well as Switzerland and Russia. Ms. Euvrard said the company expects to begin shipping the drug in December.

"We have to prepare the packaging, the leaflets, documentation for the doctors in each of their national languages," she said.

"So we can expect [RU-486] on the German market before the end of this year, on the Spanish market before the end of this year, because these two countries are our top priority."

If Exelgyn applies to Health Canada in the fall, the drug could be approved as early as January if it is fast-tracked.

RU-486 works by cutting off hormones needed to sustain pregnancy.

A woman seeking to terminate a pregnancy takes three RU-486 pills, which block progesterone. Two to three days later, she inserts another drug, called misoprostol, into her vagina, which brings on contractions of the uterus, causing a miscarriage within four to 24 hours.

The drug is effective about 95% of the time. In case of failure, a woman is usually given a surgical abortion. The side effects include bleeding, stomach cramps and nausea.

According to Statistics Canada, roughly 70,000 abortions are performed each year.

More coverage, Page B1

Protesters would find it more difficult to choose targets.

"It will not end the debate, but it will shift it," said Marilyn Wilson, a spokeswoman for the Canadian Abortion Rights Action League.

Women's groups have lobbied for more than 10 years to get RU-486 released in Canada.

However, Hoechst AG, the German chemical giant that owned the patent rights, refused to sell the drug outside of France for fear of a consumer backlash. In 1994, it relinquished the U.S. rights to the New York-based organization Population Council, which, after a long series of setbacks, is bringing the product to market this fall.

Exelgyn, a private company owned by one of RU-486's inventors, now holds the world rights.

The company has withheld the drug from Canada for years, saying it feels Ottawa has been cool to its introduction.

"We have repeated many times that we would appreciate receiving a kind of message of support from your federal government, but we have never got it," said Ms. Euvrard.

"We feel that they are not very excited about the idea of having [RU-486] on their market."

Officials in the office of Allan Rock, the Health Minister, say federal regulations prevent it from issuing such a statement, since it would put political pressure on Canada's drug approval process.

There's been no shortage of political pressure. In 1996, the B.C. government sought to fund clinical trials of the drug in Vancouver, and pushed Ottawa to make RU-486 a priority. Similarly, the Canadian Medical Association, the Society of Obstetricians and Gynaecologists of Canada and various women's groups have publicly called for the release of RU-486 for testing.

Now, it appears Exelgyn is on a worldwide market expansion.

Beginning on July 6, the company registered with health authorities in eight European Union countries, as well as Switzerland and Russia. Ms. Euvrard said the company expects to begin shipping the drug in December.

"We have to prepare the packaging, the leaflets, documentation for the doctors in each of their national languages," she said.

"So we can expect [RU-486] on the German market before the end of this year, on the Spanish market before the end of this year, because these two countries are our top priority."

If Exelgyn applies to Health Canada in the fall, the drug could be approved as early as January if it is fast-tracked.

RU-486 works by cutting off hormones needed to sustain pregnancy.

A woman seeking to terminate a pregnancy takes three RU-486 pills, which block progesterone. Two to three days later, she inserts another drug, called misoprostol, into her vagina, which brings on contractions of the uterus causing a miscarriage within four to 24 hours.

The drug is effective about 95% of the time. The side effects include bleeding, stomach cramps and nausea.

If the drugs fail, a woman is usually given a surgical abortion. According to Statistics Canada, roughly 70,000 abortions are performed each year.

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