Canadians deserve to know about side effects in drug trials

Top researchers from Canadian universities have routinely broken drug testing rules.

It’s unnerving, unethical, and literally sickening.

Canadian doctors running clinical drug trials and failing to report serious side effects suffered by test subjects. Esteemed researchers routinely breaking rules designed to protect patients — and botching research of new treatments.

Even worse, Canadians would have no idea of the truth behind the flawed drug trials if it wasn’t for records from the U.S. Food and Drug Administration, Jesse McLean and David Bruser report in Tuesday’s Star. The agency examines experiments by Canadian doctors involving Canadian test subjects to see if the drugs are safe for the U.S. market — and posts results on its website.

Meanwhile, Health Canada keeps most of its inspections of drug trials secret — despite the potential dangers to patient safety of doing so.

This pattern of secrecy enables what U.S. inspectors’ findings suggest is a pervasive problem in Canadian clinical trials. The FDA found objectionable conditions — ranging from trivial to severe — in more than 60 per cent of 192 study sites they have visited since 1981.

Meanwhile, Health Canada began trial inspections only in 2002 and has never met its goal of inspecting 2 per cent of the country’s drug trials each year. When it does find problems, it takes as many as 142 days to inform the study leaders of deficiencies, according to a 2011 Auditor General report.

When Health Canada does report on inspections, it gives out so little information as to make its findings useless: in the reports it has published it did not identify the drugs, the doctors running the trials, or the name of the drug companies. Health Canada cites confidentiality concerns for the omissions, but somehow the FDA manages to include that information.

More worrisome, with Health Canada inspecting so few of the country’s clinical trials responsibility for oversight falls to the very drug companies sponsoring the trials, as well as research and ethics boards who may be kept out of the loop or be lax in their oversight, according to findings by the FDA.

In the end, some patients had horrible adverse reactions the doctors did not report. And the potential could be disastrous for patients taking drugs where serious side effects are not reported.

Shockingly, today’s story is just another example of a dangerous tendency to secrecy and evasiveness at Health Canada.

Last week Bruser and McLean reported that some pharmaceutical companies have sold drugs they knew were defective while others had destroyed test data that showed their products were tainted or potentially unsafe. Again, the information came not from Health Canada but from the FDA.

And in June, they 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 has been collecting information on the side effects for six years, it hadn’t made the findings public.

The FDA, of course, has.

The health of Canadians is being put at significant risk in all these instances, but Health Canada won’t share the information with the public.

Why not, as the FDA does, inspect regularly and fully publish the results to ensure Canadians can be informed of risks and wrong-doings?

The current negligent, secretive attitude endangers the health of Canadians and must end. Anything less breaks the doctors’ Hippocratic Oath: First, do no harm.

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source.Thestar.com