A SHAMEFUL CULT OF INSTITUTIONAL SECRECY
Star investigation reveals transparency is deplorably lacking at Health Canada.
It’s a prescription for disaster.
Some Canadian pharmaceutical companies have sold drugs they knew were defective — putting patients at possible risk.
Others have hidden, altered and in some cases destroyed test data that showed their products were tainted or potentially unsafe, or not reported side-effects suffered by consumers taking their drugs. That’s scary enough. But more worrisome is this: Star reporters David Bruser and Jesse McLean could not get this information from Health Canada. Instead, they had to rely on detailed notes from the American Food and Drug Administration’s inspections of Canadian companies.
That’s because in addition to conducting inspections of Canadian prescription drug manufacturing facilities around the world, the FDA also makes its findings available on its website for public scrutiny.
“The U.S. regulator has posted dozens of warning letters to Canadian companies online, many of which detail egregious conditions in drug manufacturing facilities,” Bruser and McLean wrote in Thursday’s Star.
That transparency is deplorably lacking at Health Canada — and typical of too many public agencies in Canada where a shameful cult of institutional secrecy prevails.
The federal health department does not give any details of problems it finds during inspections. Nor does it tell the public the number of times it has inspected a facility.
And it would not make public the names of 20-plus companies that it itself has cited since 2012 for severe manufacturing violations.
The department also said it would take months to decide whether it would release information about 30 drug inspections the FDA had conducted on Canadian company manufacturing sites that had resulted in objectionable findings.
In some cases, it said, it would have to consult with the inspected Canadian drug companies before publicly disclosing the information. Pardon? Canadian taxpayers, who pay for Health Canada inspections, don’t have the right to know the results — without the approval of the self-interested pharmaceutical companies? Or even be reassured that the drugs they are taking are safely manufactured, as American consumers can easily confirm? That attitude is shameful and dangerous. As University of Victoria drug policy researcher Alan Cassels notes: “Health Canada is giving the least amount of information they can . . . Instead of actually increasing people’s confidence in the system, this kind of secrecy is degrading it. What’s the reason for all the secrecy?” Well we might ask. In response to the Star’s questions, the department said: “Health Canada does not allow drug products to be sold, including those imported for sale, in Canada unless there is satisfactory evidence that (good manufacturing practices) standards are being met in the facility where the product is made.”
But how can Canadians confirm that if it is not reporting its findings?
It’s not the first time the Star has noted a lack of transparency at Health Canada that puts Canadian patients at risk.
In June, Bruser and McLean reported on the dangers of doctors prescribing “off-label” drugs — ones given for a reason other than their intended purpose. The practice can be highly dangerous, and even though Health Canada had been collecting information on the side effects of off-label prescribing for six years, it hadn’t made the findings public.
Its excuse at the time? Technical limitations with the database had prevented the public release, though it would consider publishing the information in future.
Contrast that, again, with the FDA database, where the Star found nearly 400 off-label cases detailed from 2010 to 2013 that involved a wide range of suspected side effects, including heart attacks, strokes, birth defects and organ failure.
Canada has a federal department tasked with protecting Canadians’ health. It can do that better by reporting all its findings to the public — and acting quickly on them.
It should do so.