"Hey bro, you're on your own if these kill you." -Health Canada. via WikiCommons.
Last weekend, when the Toronto Star published their front-page investigation about how Health Canada does not have the ability to recall a prescription drug—even if the drug is killing human beings—unless the pharmaceutical company agrees, a lot of people got a bit freaked out, including me. I always thought the whole point of Health Canada was to make sure that what we buy wouldn’t kill us. I guess not.
It turns out, after Health Canada approves a product, the onus goes onto the drug company to recall it—not the government. If the company doesn’t agree to recall the medication immediately, it could take months or years before the drug gets taken off of pharmacy shelves. Meanwhile, the drug is wreaking havoc in the wild, i.e. your body. This lack of government power has caused a few problems in Canada. For example, in the case of the birth control pill Alysena-28, the public was informed 17 days after Health Canada knew it wasn’t working. That resulted in 40 surprised new moms.
Health Canada maintains they must prove without a shadow of a doubt that the negatives outweigh the positives to recall a drug, which sounds like a long bureaucratic process, but if they do come to that conclusion shouldn’t they be able to pull the trigger and yank a drug ASAP?
Interestingly enough, in 2008 the Conservative government tabled an amendment to the Food and Drugs Act to give Health Canada that power, but Bill C-51 died before seeing the light of day, after thousands of people signed a petition complaining about a provision that would regulate natural health products as drugs. Since the ability to recall unsafe drugs was on the same bill as the unpopular natural health product regulations, the drug recall baby was thrown out with the natural health product bath water.
In the meantime, five years have passed and Health Canada still cannot make recalls—but that might change soon. The government mentioned in the throne speech that we should be seeing new “patient safety legislation,” that will finally give Health Canada the power to recall and report unsafe drugs.
But expect some pushback from “big pharma.” According to Matthew Herder, an assistant professor at Dalhousie University’s Faculty of Medicine that I spoke with over the phone, “if they introduced a provision that would give [Health Canada] that power there would be opposition I’m sure.”
Clearly he’s referring to the power of the pharmaceutical lobby—which must have some serious clout in Ottawa—when you consider how odd it is that the government can’t recall harmful pharmaceutical drugs, when they have that power for toys, tools, cleaning supplies, clothing, and food.
The apparent lobbying influence the pharmaceutical industry has gives some companies the confidence to break the rules. One drug company, GlaxoSmithKline, got caught bribing physicians and making false claims—and was later fined $3 billion.
Originally, the sole function of Health Canada and the US Food and Drug Administration is to make sure companies weren’t making false claims like GSK. At the time, there was no testing of products before they got to consumers. That awful policy lasted up until a drug called thalidomide was being prescribed to expecting mothers for morning sickness and ended up causing more than 10,000 cases of birth defects in 46 countries. That drug was eventually banned in Canada along with LSD in 1962, but many people criticized Canada for taking so long and being the last country to ban thalidomide.
These days, even though we have better ways of testing drugs, clinical trials are far from perfect. We can’t put all our faith in the approval process then forget about checking in later as Herder explained to me: “clinical trials are based sometimes on a fair amount of people, but they are based in very controlled conditions and that doesn’t tell you much about when it’s approved in the real world.” Plenty of factors like race, gender, age, pre-disposed conditions, and whether people take the drug exactly on schedule can determine whether a medication will give you side-effects or not.
Take the example of Paxil, which was tested as an anti-depressant for adults, but was often prescribed “off-label” (meaning the scenario the drug is being used in is untested) to teens. This later resulted in a warning from the FDA saying that Paxil was making people suicidal. Then there’s Diane-35, an acne medication that was being prescribed as off-label birth control. Doctors have found possible links between fatal blood clots and the acne and birth control drug—particularly in the case of 18-year old Calgarian, Marit Mackenzie, who died last winter. At this point in time, Health Canada’s review of Diane-35 is not available to the public.
Scarily, off-label prescriptions are growing in popularity. A recent study from McGill University found that 11% of doctors give off-label prescriptions, and that study is incredibly limited, because only doctors in Quebec are forced to record whether their prescriptions are off-label or not. This is another issue the government will need to include as an amendment to the Food and Drugs Act.
“One of the problems of the drug regulation industry is that there is a misunderstanding—people presume a drug on the market is safe, but it’s not really,” said Trudo Lemmens, Chair in Health Law and Policy at the University of Toronto. “It depends on you, it depends on the disease you have and so on.”
Lemmens claims that Canada is trailing the US and Europe when it comes to our pharmaceutical policy. Both of those places force drug companies to follow stricter conditions and make it so clinical trails are more readily available to doctors and the public. “This allows the scientific community to flag data and problems when they are there,” he said. Still, the US doesn’t have the power to recall drugs either.
If the US and Canada make a push to get recall power from big pharma, Lemmens and Herder warn that the drug companies are going to want to get quicker or “more efficient” approval processes in return. That kind of pushback would put a big strain on the FDA and Health Canada, and it’s unclear if they even have the resources to comply. But, if the priority here is the health of human beings, and not the workload of the government or the profits of big pharma, let’s hope our government gives Health Canada recall power—because let’s face it, it’s completely ridiculous that they don’t have it already.
Follow Joel on Twitter: @JoelBalsam