A Bitter Pill

Safety of drugs is threatened by looser approval process
March 1, 2011

Suppose you wanted to gut Canada’s drug safety law and regulations. Obviously, such an unpopular initiative would have to be approached with care and finesse. How would you go about accomplishing this?

     The people who run Health Canada [better known to its critics as "Ill-Health Canada" certainly know how to get the job done.

First, you announce a series of “stakeholder” consultations on drug regulation. You call the process Health Canada Technical Consultations on Regulatory Modernization. The innocent title – who could be against modernization? – sounds as if it’s little more than standard-issue bureaucratic rigmarole. Ordinary folks are more likely to reach for toothpicks to prop open their drooping eyelids than to feel a sense of alarm.

The pharmaceutical industry, however, knows exactly what’s going on, and it’s always quick off the mark when the stakes are high.

The participants’ list for this government exercise in “public consultation” makes it obvious (but only to insiders) that the fix is in. Here is Health Canada’s recipe: one-third of participants should be drawn directly from the drug industry; one-third should be health professionals funded by the drug industry; and one-third should be drawn from patient and disease groups, also funded by industry. For window dressing, a few unsuspecting innocents are added to the mix.

When one gives these ingredients a shake and a stir, the resulting cocktail is a tasty one for the industry, but a toxic brew for the public and a heavy financial burden for our public health care system.

The drug industry is committed to maximizing profits for its shareholders. That is its fiduciary duty and its raison d’etre. In contrast, Health Canada’s mandate is to protect the health and safety of Canadians. By conceptualizing the industry and its minions as “stakeholders” in the safety process, Health Canada is following the deregulation mantra that led to the tainted blood disaster and to the deaths from deregulated water inspection in Walkerton.

Surely by now we have learned that, when industries are left to regulate themselves or when they dominate the government agencies that are meant to protect the public, the end result is big trouble.

*     *     *

What kind of “modernizations” should we expect from Health Canada’s artfully stage-managed “technical consultations”?

     First, and perhaps most important, could be a shift in the burden of proof. The “precautionary principle” would be scrapped if Big Pharma has its way. So, instead of the drug companies having to prove that their products are (comparatively) safe before they can be licensed, new products would be presumed to be safe unless critics can prove they will be more harmful than beneficial.

     The industry argues that this shift in the burden of proof will lead to a faster drug approval process, thus giving the public earlier access to potentially beneficial treatments. That’s true. But it’s also true that more highly dangerous drugs will inevitably come into widespread use before their dangers can be recognized.

     Keep in mind that the last decade has seen an alarmingly high number of lethal drugs that had to be removed from the marketplace – but not before tens of thousands of people had been killed or seriously impaired as a result of too-quick approval. Think Vioxx (rofecoxib) or Bextra (valdecoxib). The problem is already serious, but it will become more serious still when the approval process is put on steroids.

     Big Pharma is also lobbying hard for the abolition of current Canadian regulations prohibiting direct-to-consumer advertising of prescription drugs. Experience from the United States and New Zealand – so far the only two countries that permit DTC advertising – makes it clear that these ads are a highly successful promotional tool for the industry. They persuade people to “ask your doctor” for the latest and most expensive drugs.

     Tens or even hundreds of millions of dollars are spent  on campaigns for drugs. The industry calls this “public education,” but it’s an “education” that invariably exaggerates benefits and downplays harms. If DTC advertising is ever approved in Canada, the costs to our health care system will escalate dramatically, deaths from prescription pharmaceuticals will become even more common, and so will a range of serious side-effects.

     Health Canada wrapped up its “stakeholder” consultations in late January. The pro-industry recommendations that will emerge are almost certain to get two thumbs up from the present federal government.

     With a federal election looming as I write this op-ed, let’s hope that voters across the country will become aware of this grave threat to their health and welfare -- and that enough of them will strongly voice their disapproval of a faster drug approval process before it’s too late.


     (Arthur Schafer is a CCPA Research Associate and Director of the Centre for Professional and Applied Ethics at the University of Manitoba.)