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Op-Ed: Health Canada under fire for serious public health risk issues

By Paul Wallis     Sep 15, 2014 in Health
Toronto - The Toronto Star has exposed major failures related to Health Canada’s conduct of its operations. A pattern of dysfunction, including "useless" information, a culture of hiding serious drug defects, and a lot more is emerging, and it's a sick picture.
The Star has run two articles so far detailing its discovery of FDA information related to a range of Canadian clinical trials and related matters. Information released so far includes dangerous human trials, defective drugs, and major side effects.
Health Canada’s approach to providing public information, which the Star describes as “useless,” could also be said to be truly bizarre by international standards. A culture of non-information, secrecy and general impotence is the image emerging from the reports thus far.
In its initial article, the Star reported:
1. Sales of drugs known to be defective.
2. “Hidden, altered, or destroyed” test data.
3,Non-reportage of side effects, including blood clots and other serious incidents, experienced by test subjects.
40 Canadian companies, including industry leader Apotex, have been implicated in these matters. 19 inspections of Apotex by the FDA since 2008 have recorded “objectionable” findings.
These are quotes from an extremely lengthy FDA letter to Apotex on public record which refers to just a couple of multiple issues raised in a previous inspection:
… Your firm’s practice of rejecting portions of drug product batches is an indication that your firm does not have well-controlled manufacturing processes. In addition, it raises concerns about the quality of the portions of those batches that you released.
… In the foregoing and many other investigations, you did not identify the true root cause(s) of the various deficiencies. Accordingly, the actions taken often did not prevent recurrence of the problems.
The letter details numerous deficiencies and unfulfilled promises by the manufacturer. (Apotex now states that it has in fact remedied the issues identified by the FDA.)
The second Star article reports systemic failure of the testing protocols, including failure to report and breaking rules designed to protect patients. In an even stranger but even less reassuring twist, the FDA checks test results because Canadians are carrying out research for drugs intended for the US market. Health Canada has yet to meet its 2002 target of inspecting 2 percent of trials, according to the Star.
Big Pharma strikes again? … Or is Health Canada crying for class actions?
The contribution of the pharmaceutical industry to the suffering and further misery of millions of sick people around the world is well-known. Defective drugs, dangerous side effects, and endless recalls are the symptoms of this irresponsible, money-mad, sociopathic, extension of the financial sector. Endless regulatory and civil actions costing enormous amounts of money in penalties have made no impression on the sector. The pharmaceutical industry, which apparently believes that mass murder at extortion rates is its main role, obviously couldn’t care less.
Knowledge and basic ethics also aren’t at a premium in an industry where the most astonishing lapses of basic product management can be settled out of court for a few spare billion dollars whenever they happen. The world knows that. Even regulators and a few politicians know that.
However-
When it’s the regulator falling down on the job, it’s a very different ball game.
If the duty of Health Canada is to protect the public interest and safeguard public health in its role as regulator, Health Canada could be held to be a party to the deficiencies of any regulated drug in Canada. This is a duty of care, and it’s not transferable.
If the Star’s findings are correct, this is potentially “unlimited liability” applying to the Canadian government. Negligence alone, let alone systematic, — and fully documented — total failure to carry out its statutory responsibilities, would be potential grounds for lawsuits and class actions.
The issues detailed in these reports are unbelievably dangerous and could directly impact the health of tens of millions of people. There is absolutely no excuse for the Canadian government not to act in regard to these failings of a major regulator. The US government, too, would be well within its statutory powers to take appropriate action penalizing Canadian manufacturers for serial breaches of law.
It’s bad enough that governments around the world can’t think of any particular reason why people should be healthy. It’s quite enough that the industry itself appears to be run by genocidal maniacs without the vaguest interest in public safety or health.
The difference is that there’s a lot of recourse against a regulator that doesn’t do its job. One test case is all that’s needed to put this situation in perspective in legal terms. If it should later emerge that there was any collusion with industry to hide information, so much the better for claimants.
It should also be noted that manufacturers can be de-licensed about as fast as a phone call. Any competent government should be well aware of that fact. So should manufacturers. This 30 year holiday for companies which seem to do nothing but break the law has to end sometime. Now would be appropriate.
This opinion article was written by an independent writer. The opinions and views expressed herein are those of the author and are not necessarily intended to reflect those of DigitalJournal.com
More about Health canada, Apotex, Fda, drug trial evidence tampering, Health Canada culture of secrecy
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