New Pill, Old Headaches

(Jim Rankin/Toronto Star/Getty Images)

Few drugs have arrived in Canada accompanied by more fanfare, delays, hope, controversy and politicking than Mifegymiso, the pregnancy-termination medication approved by Health Canada in 2015 after a two-and-a-half-year process. The drug began shipping to a handful of hospitals and health centres only last month.

At the very moment reproductive rights in the U.S. are coming under assault—with Canada upheld as a progressive bastion of abortion access—the Mifegymiso story reveals continuing barriers to reproductive health for Canadian women, as well as “abortion exceptionalism,” a double standard surrounding the procedure, even in a country where provincial insurance plans have covered surgical abortion for decades. In one grim detail, Health Canada took the rare step of removing the names of reviewers who approved the drug from its website due to threats against them.

Canada lags more than 60 countries in providing misoprostol, a medical abortion drug that induces miscarriage; France has offered it since 1988, the U.S. since 2000. It’s also on the World Health Organization’s essential medicines list. The reason was simple: no manufacturer had submitted an application until France-based Linepharma Inc. commenced talks with Health Canada in 2008. “It wasn’t seen as cost-efficient,” says Dawn Fowler, Canadian director of the National Abortion Federation. Others say the omission is telling of a historical lack of leadership on women’s health care, particularly abortion access. “Health Canada isn’t proactive,” says Sandeep Prasad, executive director of the Ottawa-based Action Canada for Sexual Health & Rights. “It doesn’t seek out needed drugs, which is why we don’t have access to contraceptive implants,” as are available in other developed countries.

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Mifegymiso is a two-drug regimen: mifepristone to block production of progesterone, which prepares the uterus for pregnancy, and misoprostol, taken 24 to 48 hours later. Its initial labelling in Canada signalled the sort of danger one associates with, say, handing asbestos to children. To be certified to prescribe it, doctors have to complete a six-hour online course; such certification has been limited in the past to select cancer drugs and methadone. Pharmacists were shut out: only certified doctors with access to ultrasound could prescribe and dispense to women up to 49 days of pregnancy; this included supervising the swallowing of the first pill, like overseeing a sick child. Dustin Costescu Green, a Hamilton, Ont.-based OB/GYN who co-chairs the training program run by the Society of Obstetricians and Gynaecologists of Canada (SOGC) says that’s unique, “the first time in women’s health we’ve had a product that required such rigorous training.”

Keeping the process in the hands of doctors can seem paternalistic but is crucial, says Costescu Green, “to prevent the potential for abuse, to ensure the patient receives the correct product and the product dispensed is given to the right patient.” Yet international examples of misoprostol abuse are rare, he says: “I don’t know if there are any in public literature.”
Response to these regulations, combined with outrage over the uninsured drug’s $300 price tag being just one barrier to access, revealed medical activism was alive and well. B.C. pharmacists successfully lobbied to dispense the drug, as is the case in Australia, under certain conditions. Other provinces are expected to follow suit.

Labelling has been modified; the drug can be taken at the discretion of a health care professional, which means women could take it at home. Distributor Celopharma Inc. has applied to Health Canada for permission for pharmacists to dispense directly to the patient if indicated by the prescriber, and to increase gestational limit to 63 days (the FDA extended the limit to 70 days in 2016). The company expects a response by the fall.

Women’s-health advocates express concern that the rules mean Mifegymiso won’t help expand access to abortion; instead, existing surgical abortion providers will just add it as a service. The first shipments have been sent to hospitals and health centres in B.C., Alberta and Ontario. And this is a problem in a country where abortion is centralized in the largest cities within 100 km of the U.S. border, with a dearth of providers in rural areas, says family physician Wendy Norman, an associate professor at UBC’s School of Population and Public Health. Yet the need exists. A 2012 study Norman authored found 31 per cent of Canadian woman have had at least one abortion.

The drug’s arrival will not transform physicians into abortion providers, says Costescu Green, citing international data: “Abortion rates don’t go up, but medical abortion rates go up.” It’s a choice many women make. Planned Parenthood in the U.S. reports that half of women seeking an abortion request medical abortions. In Europe, 80 per cent of abortions are medical. In Canada, some 300 doctors and pharmacists have enrolled in or taken the course, which began in January, the SOGC reports. Celopharma reports that 70 doctors, and “very few” pharmacists have completed it.

Expecting doctors to be drug dispensers is a disincentive for family doctors to prescribe, says Lianne Yoshida, the medical director of the abortion clinic at Halifax’s Victoria General Hospital: “They don’t have the same options as free-standing clinics to stock, nor are they set up to receive payment.” There is also the inconvenience for the patient. “I can see a patient, do evaluation and counselling. I can write her prescription, which she takes to the pharmacy, where the pharmacist has done the training; they accept the prescription, accept the payment, order the medication and have it delivered to my office. It’s silly.” Such hoops signal discomfort with abortion, says Prasad: “Those needing access have to work harder, and we don’t trust those seeking abortion care to responsibly take medication that will safeguard their health.” Others see a risk of restigmatizing abortion: “You’re defeating the access benefit by insisting on physician dispensation and observation,” says Jocelyn Downie, a Dalhousie University law professor specializing in health law. “You’re also making this seem like an exceptional intervention. And it’s not.”

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Supriya Sharma, chief medical advisor with Health Canada, calls Mifegymiso a unique product. “It’s not used in a standard way; it’s replacing a surgical procedure,” she says in an interview with Maclean’s. “Significant politics” exist around the drug, she says: “We got letters that were critical. We had marches focused on the product.” The agency ignored the fray, she says: “We made sure we were treating it as any other drug, and [the review] was based on science, evidence and law.”

Yet the Mifegymiso “facts vs. myths” page on Health Canada’s website isn’t standard practice (the other example offered by the agency is a page discussing naturopathic remedies). These “myths” include “The medication has lower risks than surgical abortion” and “Requiring the medication to be taken under supervision is unnecessarily restrictive.”

Yoshida questions posting such information, noting all drugs have potentially scary side effects. “It’s bizarre, considering how safe this medication is,” she says. (Repeated studies show misoprostol to be only slightly less safe and effective than surgical abortion, which has a better than 98 per cent success rate.) The messaging concerns her: “The delays, the training, the physician dispensing sends the clear message: ‘This is dangerous to women.’ ”

Research to discern how to make the drug more accessible is in the works. Norman’s UBC team received a Canadian Institutes of Health Research grant to investigate barriers faced by physicians and pharmacists, particularly in rural areas. Breaking through is key to access, says Downie. “If doctors can offer it in the privacy of their offices, they won’t feel vulnerable to stigmatization and ostracization that can be associated with a clinic.”

Adding nurse practitioners or midwives as providers, as is the case in the U.S., is seen as another strategy. Costescu Green says it’s up to nurses and midwives to express interest: “We depend on those organizations to come forward and be involved in the discussion and process.” Josette Roussel, senior nurse adviser with the Canadian Nurses Association, says they weren’t contacted by Health Canada about Mifegymiso until last year. Nurses serve as primary care providers for more than three million Canadians, she says. Members in New Brunswick have already expressed interest in providing the drug and have asked the association to advocate. (Celopharma also cites telemedicine as an option for medical supervision in remote areas.)

Insurance coverage is the next battle. The Canadian Agency for Drugs and Technologies in Health, which advises all the provinces except Quebec on drugs to cover, will review Mifegymiso in March (Quebec is reviewing coverage separately). Norman wants provincial governments to subsidize all women, as with surgical abortion, “not only those on social assistance.” Certainly the system is structured for surgical abortion, which can cost up to $1,500. “But medical abortion can help reduce demand for surgical time—and women get their care faster,” Fowler notes.
Speaking to doctors and activists, it’s clear that despite the frictions, Mifegymiso has forged new alliances. One upside, says Norman, is that medical groups, not industry, coordinated the training. Downie speaks of a more responsive Health Canada. After she was publicly critical of pharmacists not dispensing, a Health Canada official called her to discuss the issue: “I’m hopeful this is a sign of a new era of listening,” she says.

Anusa Sivalingam, board chair of Yellowknife Women’s Society, is also hopeful, noting women in the north don’t receive “the full suite of reproductive services.” It’s not clear yet how the drug will be distributed to more remote regions, “but we’re optimistic and think it was a good step it was approved.” Costescu Green expects to see disparities across the country: “In different provinces, there will be different practices.” And that means the fight for equitable reproductive health in Canada must rage on.

Source: Macleans