Canada’s soon-to-launch clinical trials database: how does it measure up?
By Julia Belluz - Monday, May 13, 2013 - 0 Comments
Neeta Lind / Flickr
Any day now, the Canadian government is going to announce a website that federal health minister Leona Aglukkaq is calling a coup for transparency and patient access. The soon-to-be-launched database of clinical trials happening in Canada will go live before the end of May (Health Canada could not confirm the date), which means Canadians will soon have a one-stop shop for information about what pharmaceutical products are being tested on humans in this country.
Before your eyes glaze over at what sounds like a regulatory snooze fest, know that how our government regulates clinical trials impacts anyone who uses or prescribes pharmaceuticals. It also affects all those brave souls who give their bodies over to science in the hope that they’ll not only get help with an ailment, but also contribute to the advancement of knowledge about treatments and human health.
Right now, it’s estimated that about half of all trials run globally never see the light of day. This is because scientists—both independent and those working for the pharmaceutical industry—are more inclined to publish studies about drugs that have positive results, a phenomenon known as publication bias. As Sir Iain Chalmers, a British researcher and one of the founders of the Cochrane Collaboration, asked, “How many (patients) would have agreed to participate (in a trial) if researchers had told them, ‘If the results of this trial don’t serve our academic or commercial interests we won’t make them public?’”
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Health Canada responds to questions about hidden clinical trial data
By Julia Belluz - Friday, November 2, 2012 at 12:24 PM - 0 Comments
(Jeffrey Coolidge/Getty Images)
In Canada, pharmaceuticals are one of the fastest-growing cost drivers in our health system. And we are gobbling up prescription drugs with increasing enthusiasm. Between 1997 and 2007, Canadians were second only to Americans when it came to increases in per capita drug spending.
Yet the data we collect from clinical trials about the drugs we take remains largely hidden from view: it’s not available for examination by independent researchers, and the information about drugs that is published tends to be positive, an unrepresentative sliver of all that’s known. As the editor of the British Medical Journal and other doctors around the world have pointed out, this means patients, doctors and governments can’t make fully informed decisions about treatments.
This is a problem that affects anyone who uses pharmaceuticals — or their loved ones who do. Because of this situation, jurisdictions around the world have been working to make the clinical trials process, the testing of drugs, more open and transparent.
Yet Canada lags here. As Science-ish noted in an open letter to the Federal Health Minister Leona Aglukkaq, and subsequently, letters from researchers, the recent announcement about the government’s intention to create “a web-based list” of clinical trials for Canadian patients seems to reflect what was known about this issue over a decade ago, and ignores the evidence that’s been gathered since then.
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Dear Leona Aglukkaq: Researchers write the health minister on clinical trials
By Julia Belluz - Tuesday, October 30, 2012 at 2:35 PM - 0 Comments
Andrew McCaul/Getty
Last week, Science-ish published a letter to the Honourable Leona Aglukkaq, Canada’s Federal Minister of Health, in response to an announcement she made about the government’s intention to create “a web-based list” of clinical trials for Canadian patients.
On the surface this sounded like a great idea—a way to improve patient access to and knowledge of clinical trials happening in this country. But like most things, the reality is a little more complicated. As Science-ish explained, such a listing hasn’t empowered patients in other jurisdictions, and it probably won’t here. It’s completely out of step with the evidence and it ignores on-going conversations that have been happening for about a decade regarding clinical trials registries and open data here, and around the world.
Science-ish has been steadfastly working on obtaining a comment from the minister about the plan. After numerous phone calls and emails, the minister’s press secretary, Cailin Rodgers, agreed to look into the issue. She did not respond by deadline.
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Saskatchewan goes rogue on CCSVI clinical trials
By Anne Kingston - Friday, January 13, 2012 at 12:58 PM - 0 Comments
Brad Wall: ‘It’s a good day in the province of Saskatchewan’
Yesterday Saskatchewan Premier Brad Wall left the Canadian Institute of Health Research (CIHR) and the MS Society of Canada in the dust when he announced his government has allocated $2.2 million for 86 multiple sclerosis patients in Saskatchewan to participate in Phase II clinical trials into chronic cerebrospinal venous insufficiency, or CCSVI, currently underway in Albany, NY. (Phase II trials consist of randomized treatment in a clinical setting, as opposed to Phase I trials, which research the safety and efficacy of a drug or procedure.) Applications, which will be accepted until Feb. 24 from patients who fit trial criteria, will be chosen randomly. Results from the lottery, one destined to be oversubscribed, could be announced as early as March. “It’s a good day in the province of Saskatchewan,” the premier said at a press conference, adding that very few residents of his province, which has one of the country’s highest incidence of MS per capita, have not been touched by the disease. He also noted the FDA has approved the Albany trial, the largest double-blinded study yet into the venous angioplasty treatment for MS pioneered by Italian vascular specialist Paolo Zamboni.
Anyone following the tortuous politics in the battle for CCSVI clinical trials in Canada over the past two years couldn’t help but read the comment as a not-so oblique reference to the fact the CIHR, which did an about-face on a previous decision not to fund clinical trials last year, has yet to announce its research team into Phase I trials (Phase II trials aren’t on the radar). Or that the MS Society, which allocated $700,000 into ongoing studies reviewing only the efficacy of CCSVI scanning, not treatment, has not exactly been a trailblazer on the issue, one that has dominated MS-patient activism in the past two years.
In sending Canadian MS patients to the U.S., after failing to get a home-grown trial off the ground, the premier is also debunking any myth that Canada is “a leader” in CCSVI research. Though the Albany trial is expected to take two years, Wall is already strategizing. While saying he didn’t want to get ahead of himself, the premier did allow that “if we find any symptom relief for MS, treatments that work for the many who suffer—the 3,500 plus in this province—I think it will be incumbent on the province of Saskatchewan to provide those proven and efficacious treatment to those patients.” Those are compassionate words. They’re also fighting words, suggesting that Saskatchewan, the home of once-universal Canadian health care, could also be ground zero for furthering CCSVI science—and possibly providing new treatment for a mysterious, incurable condition that afflicts so many Canadians.
