Will Canada follow US lead on RU 486?

After 17 years of debate, mifepristone (RU 486), the controversial pill that induces early abortion, is for sale in the US. The drug's Canadian proponents hope this country will soon follow suit.

“It's amazing that they got it through,” says Bonnie Johnson, executive director of the Planned Parenthood Federation of Canada (www.ppfc.ca/). “It means women now have a choice. The big thing for us is it takes [abortion] off the streets — it becomes a private thing between a woman and her doctor.”

Health Canada has agreed to fast-track approval of the drug, but “[Canada's] problem isn't approval,” says Johnson, “it's getting a manufacturer, someone who is willing to take the risk of marketing and promoting it. They'll have to wear armour.”

Dr. André Lalonde, executive vice-president of the Society of Obstetricians and Gynaecologists of Canada (SOGC), agrees. “We're never going to get a company to bring it forward for approval,” he says. The program currently considers only those drugs presented by manufacturers. Lalonde says the key is to get the program to change and accept an application from another group as a “public health measure.”

That's exactly what happened in the US. The Population Council holds the US patent for mifepristone, while the manufacturer is Danco Laboratories.

Mifepristone, a progesterone blocker, can be used safely to induce abortion in women who are up to 8 weeks' pregnant. After confirming pregnancy and determining dates, mifepristone is prescribed. Two days later the woman takes misoprostol (unless the physician confirms that the pregnancy has terminated); this drug causes uterine contractions. In the US, the bill for the drugs, physicians' charges, counselling and other fees totals about $270. The main advantages of RU 486 is that it allows earlier, nonsurgical abortions.

Mifepristone, which was first approved for use in France in 1988, has been used by 620 000 women in Europe. The death rate among women using the pill is 1 per 200 000, almost the same as the rate for surgical abortions.

Canadian women may try to buy the drug in the US, says Dr. Ken Milne of the SOGC. He says some of his patients have bought combination birth control pills in the US. However, he warns that if Canadian women manage to get RU 486 across the border it is “essential that they confide in their physicians. To withhold may well jeopardize their well-being.”

In the US, 87% of counties don't have an abortion provider and studies indicate that the number of doctors providing abortions decreased by 14% between 1992 and 1996. US approval of RU 486 came with some restrictions: the drug must be administered by or under the control of a physician. This means that other health professionals, such as nurse practitioners, can administer the drug. The professional has to know how to date conception, rule out a tubal pregnancy and be able to perform or to arrange a surgical abortion if one is needed. Instead of being sold in pharmacies, the drug will be ordered directly from the manufacturer by physicians.

Detailed patient information is available and a patient agreement, which stipulates that the woman must return for a follow-up appointment, has to be signed before the drug can be administered. Physicians must also sign a form indicating that they understand the method.

The SOGC passed a resolution in 1992 supporting the “legal availability” of antiprogesterone steroids such as mifepristone in order to give “Canadian women access to treatment of proven efficacy.” Lalonde says withholding approval is an “insult to women — they're being treated like babies, being refused access to this and that when it comes to their health.”

Not everyone is as enthusiastic. Mary Ellen Douglas, national organizer for Canada's Campaign Life Coalition (www.lifesite.net), told CMAJ: “The result of taking this pill is a dead baby, and that's certainly not a drug we need here.” —