Can we trust our government and our medical establishment?
Incomplete. Some insights into Health Canada’s approach to prescription drug safety are less than safe. Public policy should be geared towards more, not less, drug safety.
Health Canada was funded entirely by taxpayers until 1994 when it began charging user fees to companies seeking approval for their drugs.
Usage fees make sense in many circumstances, but maybe not here. Half of Health Canada’s prescription The drug program came from user fees, and a senior Health Canada official admitted it turns drug companies into customers.
It does not seem accidental that drug approval seemed to accelerate after 1994. This helps drug manufacturers, but not patient safety. Studies have shown that one of five drugs With a 300 day review, serious side effects will not show up until they are on the market. For drugs that have only been reviewed for 180 days, this also applies to every third drug. Only when that is the case one of 10 new drugs is significantly better than existing ones, the rush does not seem to be justified.
There are other problems. For the past 10 years, Health Canada has been dedicated three times as much money and the staff to approve drugs as they need to ensure that drugs that have already been sold are safe. Critics also warn against it The standards for the approval of new drugs have become weaker.
Pharmaceutical companies in the US have paid billions in settlements to illegally advertise drugs for off-label purposes. Still a Health Canada spokesman he said Toronto Star in 2014 that the regulator “has not been made aware of a similar problem in Canada and has not received any complaints about these companies promoting the off-label use of their products in Canada.”
On the other hand, the regulator did not provide any evidence that they even looked.
Worse, Health Canada knew if off-label prescriptions were related to an incident of dire side effects, but for some reason never recognized it in the records. You had to contact the Food and Drug Administration (FDA) in the US, which is collecting data on side effects from other countries, to fully disclose the Canadian cases.
Health Canada sometimes issues warnings later than in other countries. In mid-2013, the US warned that the blood thinner dabigatran could cause severe or fatal bleeding. Canada did not issue such a warning until early 2015.
The US ripped cisapride off the shelves on July 14, 2000 because it was associated with deaths from irregular heartbeat and cardiac arrest. Canada kept the gastrointestinal drug on the market for another month. Fifteen-year-old Canadian Vanessa Young died of a heart attack from cisapride that year. Her father, Terence Young, became a MP and saw through the passage of Vanessa’s Law It eventually gave the Minister of Health the power to issue a drug recall that Health Canada has so far only been able to negotiate with pharmaceutical companies.
But Canada’s problems are far from over. In March 2020, Ulipristal, a drug used to treat uterine fibroids, was used suspended for use in Europe because of links to liver damage. Health Canada warned of the risk in early 2019, but kept the drug on the market until its manufacturer voluntary withdrew it on September 30, 2020.
Sometimes the regulator turns one eye into useless drugs. In January 2019, a study was conducted with Lartruvo, a drug used to treat soft tissue sarcoma. showed the drug wasn’t working. Its maker, Eli Lilly, pulled the drug from the US and Europe. Health Canada too announced the drug did not work, nevertheless it remains for sale.
While less control seems like the last thing Canada needs, some people think differently. In 2018 Canada suggested Just give a cursory review of the drugs on an “urgent public health need” list and stamp it off if the US or Europe has already done so. This is risky as ratings can vary widely. Researcher investigates Safety Notices issued by regulatory agencies in the United States, United Kingdom, Canada, and Australia from 2007 to 2016. The agencies issued the same warnings only 40 times, making up seven percent of the nations’ total drug warnings.
If it’s so easy for regulators to overlook problems, the last thing Canada needs to do is put in a sloppier process of its own. If it is to rely on the wisdom of other countries, it seems far smarter to err on the side of caution than supply. A cure should never be worse than the disease, and if regulators don’t do due diligence, this is exactly what can happen.
Lee Harding is a research fellow at the Frontier Center for Public Policy.
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