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Editorial: Study on drug left unfinished

Why won’t the provincial Health Ministry complete a study of the smoking cessation drug Champix? That’s the question Heidi Clow’s mother is asking, and with good reason. Heidi was a 22-year-old navy steward from Colwood.

Why won’t the provincial Health Ministry complete a study of the smoking cessation drug Champix? That’s the question Heidi Clow’s mother is asking, and with good reason.

Heidi was a 22-year-old navy steward from Colwood. She had no history of anxiety or depression. Yet four months after being prescribed Champix, she killed herself.

The ministry began a review of the drug two years ago, but the work was halted after staffers were fired for allegedly mishandling data. Co-op student Roderick MacIsaac was researching files on Champix when he was dismissed. He took his own life three months later.

The ministry has since apologized for its treatment of MacIsaac, and some of the fired staff have been re-engaged. But the Champix study remains on ice.

Yet Heidi’s suicide is only one of several allegedly connected to this medication. According to the Toronto Star, 24 Canadians using the drug have killed themselves.

Champix has already been “black boxed” south of the border, meaning packages must carry the strongest health warning. The U.S. Food and Drug Administration cautioned “it appears increasingly likely that there is an association between Chantix [the American brand name] and serious neuropsychiatric symptoms.”

Then last week concerns were raised about another smoking-cessation drug, bupropion. The B.C. Drug and Poison Information Centre warned that 22 patients taking the medication had been admitted to critical care in the last year. One died.

We have to pause here and give the other side of this story. To date, there is no proof that Champix is to blame for any suicide. A large study in Britain found no clear evidence of such a link.

The manufacturer, Pfizer Canada, has co-operated with government agencies, and it’s entirely possible the drug is safe when used properly. Equally, there is no proof that bupropion is dangerous. People who give up smoking often experience withdrawal symptoms, and that is a possible explanation.

Nevertheless, there is a broader issue here. The drug-licensing process in Canada relies almost entirely on pre-market trials that are conducted in closely supervised conditions. Those trials are completed before any medication hits the shelves.

Yet it can take years for serious side-effects to become recognized, especially if they are relatively rare.

The arthritis drug Vioxx was introduced in the late 1990s and approved for use in Canada. But over the following five years, it was found that patients using the medication had a heightened risk of heart attacks. Vioxx was withdrawn in 2004.

The solution to this problem is to require follow-up studies at regular intervals. The Therapeutics Initiative, a research agency at the University of British Columbia, specializes in this work.

The agency was partway through an investigation of Champix when the provincial Health Ministry yanked its funding and halted the study.

The funding was later restored, but the ministry hasn’t allowed the Champix study to continue. Ironically, it was the Therapeutics Initiative that first raised questions about Vioxx.

The government’s response is that a federal agency is already reviewing Champix. However that study, once again, will build on pre-market trials.

In contrast, B.C. has the means to investigate how Champix performs in real-life situations after it is released.

The ministry has one of the most complete databases in North America. It might take as little as six months and $50,000 to see how patients are responding. Experts consider this form of review superior when health concerns arise.

Surely, this is knowledge worth gaining. If the drug is safe, users can rest easy. If not, the sooner we find out, the better.

All medications entail some degree of risk. But we’re not curing cancer here. We’re helping smokers kick the habit.

The ministry should finish the job it began.

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