Health Canada is holding its third and final “technical consultation” on proposals to “modernize” regulations governing prescription drugs and medical devices. The closed-door meetings will take place this week in Ottawa (Jan. 19-21).
The Canadian public is largely unaware of the proposed changes, let alone their profound implications. Health Canada is working behind the scenes with the drug industry and drug industry funded groups to lower the drug safety standards and speed new drugs to market, thereby increasing the likelihood that Canadians will be exposed to dangerous new drugs.
The proposed technical changes to drug regulation are part of a broader plan to introduce new legislation based on risk management and a lower standard of safety which will replace the current Food and Drug Act, which has as its central aim the protection of public health.
The precautionary principle will be scrapped and the burden of proof will be shifted. So, instead of the drug industry having to demonstrate their product is safe, new drugs will be presumed safe and harm will have to be proven.
This will mean the minister of Health can decide in secret, that the ‘benefits’ of a new drug outweigh the ‘risks’ even before adequate safety research is conducted.
The new evidence standards for marketing new drugs, to quote Health Canada, will be “grounded upon our understanding of what Canadians believe federal approval of a new drug should mean.” In effect, the new standards for drug approvals will be based on opinion and emotions manipulated by industry marketing campaigns and industry-funded “patient” groups.
Shouldn’t market approval be based on rigorous scientific evidence showing a clear benefit to health? Our current system of drug regulation requires evidence that a drug works better than a placebo and that it is safe relative to the condition for which it is going to be used, before it can be marketed.
The requirement of evidence of effectiveness was brought in after the thalidomide disaster in the early 1960s. The reasoning was because a medicine could cause unpredictable, horrific harm, no exposure was worth the risk unless there were tangible benefits.
The proposed legislation, previously tabled in Parliament as Bill C-51, permits the speedy marketing of expensive new drugs—most of which provide no therapeutic advantage over safer, cheaper drugs—before the research on effectiveness and safety is completed.
Health Canada is proposing that the emphasis in drug safety research be placed on post-market ‘surveillance.’ In effect, the policy is to measure and manage the damage after the new drugs are marketed.
It is important to have rigorous drug safety followup after drugs are marketed. However, this should never be a substitute for pre-market safety and effectiveness standards. Better to prevent unnecessary harm than pick up the pieces afterwards.
Furthermore, post-marketing studies conducted by industry are 75 per cent of the time “seeding trials,” which means their purpose is to promote the drug by enrolling hundreds or thousands of physicians to encourage them to prescribe the drug.
The heavily-promoted arthritis drug Vioxx, withdrawn in 2004, caused many thousands of heart attacks and killed an estimated 68,000 people in the U.S. With Vioxx, we learned that an inadequate regulatory response to early signs of harm, combined with intensive direct-to-consumer advertising, leads to thousands of preventable deaths and to irreparable harm.
In addition to Vioxx, four other drugs approved by Health Canada between 2005-07 have since been withdrawn because they were unsafe. Canada’s drug approval system is obviously broken.
Speeding up the new drug approval process is just going to make the situation worse. One of the reasons given for the additional ‘flexibility’ in bringing drugs to market faster is that some patients with rare diseases do not have adequate treatments available, and they can’t wait for a long approval process.
This situation is very rare. But when it does occur, patients can get the new medicine through an existing Special Access Program. Rare exceptions must not be used as a pretext to an overall lowering of safety and effectiveness standards for the general public.
Finally, Health Canada’s proposed legislation and regulations lower the minister of Health’s legal ‘duty of care’ so that the federal government can evade liability for regulatory negligence when Canadians are harmed by inadequately tested new drugs and medical devices.
Health Canada should not be given a legal mandate to continue its current policy of protecting corporate interests instead of the health and safety of Canadians. It’s time to let the public in on Health Canada’s dirty little secret.
Michael McBane is the national coordinator of the Canadian Health Coalition and author of Ill-Health Canada: Putting Food and Drug Company Profits Ahead of Safety.
Original article on Hill Times website (subscription required)