Why isn’t the ‘gold standard’ of abortion drugs available in Canada?

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In Canada, there are about 100,000 abortions a year, most of them performed surgically in clinics or hospitals. Access to the procedure varies widely across the country. Wait times are short in the largest urban centres, though may still take several weeks, but options are extremely limited in Atlantic Canada and many rural communities. Even women in smaller cities must often travel hundreds of kilometres to access a clinic.

Medical abortions, experts suggest, are one way to improve earlier access to abortions, and protect privacy because patients could potentially go to their family doctors, and wouldn't need to visit a clinic – an important option for women from ethnic or religious groups that oppose abortion.

Currently, for medical abortions, Canadian women have access only to methotrexate, a chemotherapy drug, administered orally or by injection, that stops pregnancies. It can only be used in the first seven weeks of the pregnancy.

Another drug – Mifepristone – is considered the "gold standard" drug for medical abortion. The World Health Organization has declared it an "essential medicine" and, according to statistics cited in a recent editorial in the Canadian Medical Association Journal, it is now used in about 60 per cent of abortions in Europe and 20 per cent in the United States.

Taken orally, mifepristone blocks the production of progesterone which prevents the pregnancy from continuing. In other countries, it has been approved for use up to nine weeks.

Both drugs are taken with misoprostol, which causes contractions, and bleeding similar to a miscarriage. But having a medical abortion using methotrexate can involve a much longer process – patients typically wait three to seven days before taking the second drug. According to Dr. Wendy Norman, an assistant professor in the medical faculty at the University of British Columbia, who specializes in family planning, only about 60 per cent of women will have completed the abortion within a week, and some patients may wait several weeks. In up to 10 per cent of patients, women will have surgery – either because the pregnancy is still growing or to manage bleeding or because of the long wait.

By comparison, mifepristone usually works much faster, making it easier for physicians to monitor patients. The second drug, misoprostol, is usually taken within 48 hours, and research shows that two-thirds of women who have a medical abortion using mifepristrone will have a complete abortion within four hours after taking misoprostol, and 90 per cent within one day.

Mifepristone is the preferred option, medical experts say, because it works more quickly, has proven to be more effective and is less toxic. (In fact, as the CMAJ editorial pointed out, the World Health Organization does not recommend methotrexate for abortions because of the high risk of severe birth defects if the pregnancy continues.)

Concerns were raised about medical abortions around 2000, says Norman, when there was a cluster of cases in which women died from an infection – antibiotics are now prescribed as a precaution. Some groups have raised concerns about the use of medical abortion potentially isolating women when they have abortion, and preventing them from receiving counselling or support.

As the CMAJ reported, the issue is that Canadian women only have access to the second-best option. "There is no evidence to suggest that it isn't a very safe drug, and we have a lot of evidence to suggest that it is," says Dr. Sheila Dunn, research director of the Family Practice Health Centre at Women's College Hospital in Toronto and co-author of the CMAJ Editorial.

Norman agrees: "There is no scientific basis that can justify withholding the benefit of this medication from Canadian women. It's beyond logic and scientific evidence to try to explain the decisions that are being made."

According to Dunn, Health Canada received an application to approve mifepristone in October, 2012. "The results are pending," the editorial states. "It is important that this submission must not fail."