Big Pharma versus the health of Canadians

The problem of regulators becoming captive of the regulated is not a new concept.  Kevin Taft, former Alberta Liberal leader, wrote about it in his book Oil’s Deep State. I see it all around us – in the National Energy Board approach to pipelines, in the Canadian Environmental Assessment Agency’s unwillingness to return to proper environmental reviews, in NavCan describing the airlines as their “clients.”

But something rotten is going on in Health Canada.

In the 41st Parliament, when Rona Ambrose was Minister of Health, the crusading MP from Oakville, Terence Young, accomplished the near impossible – the Government of Canada took on Big Pharma.  There was nothing in Terence Young’s conservative background to suggest he would become a foe of Big Pharma. Young would never have been a thorn in the side of multinational drug companies if they hadn’t killed his daughter.

At 15 years old, Vanessa Young collapsed at the foot of the stairs at home, in front of her father, and died from a heart attack.  She had been prescribed the drug Prepulsid for minor indigestion issues.  No law required their doctor to know or the drug company to communicate to her mom and dad that eight infants had died during clinical trials ten years before.

The tragedy that hit the Young family was not that unusual. Used as directed, it is estimated that prescription drug use leads to 150,000 deaths every year in North America.

In 2014, Vanessa’s Law received Royal Assent.  It gave the Minister of Health, for the first time, the power to recall a dangerous drug.  Even after the Thalidomide disaster, Health Canada had only the powers to ask the drug companies for a voluntary recall.  It also opened up the secretive culture of protection of data that could hurt a drug company’s profits.  Under Vanessa’s Law, the Minister of Health may require drug companies to release clinical trial data to independent researchers. It was with a non-partisan spirit and a sense of triumph that our House and Senate passed Vanessa’s Law.

Since then, we are more aware of how Big Pharma has directly led to one of Canada’s current health emergencies. Canada has a particularly high rate of opioid addiction, as the population with the second highest rate of prescription opioids in the world. It was in the 1990s that the drug manufacturers marketed the drug Oxycontin as a great pain reliever, with a low risk of addiction. It was true that  Oxycontin is 1.5 to two times more potent in relieving pain than morphine.  It was completely untrue to claim it was not addictive.  It was far more addictive than other prescription painkillers.

But four years after Vanessa’s Law received Royal Assent not a single regulation has been brought forward. Worse, draft regulations undermine the act’s purpose.  Already, the Guidance Document, created by Health Canada to implement the law, protects Big Pharma and undermines the health of Canadians.  This was all revealed in detail by Terence Young (Failure to enforce Vanessa’s Law is a deadly game, November 5, iPolitics).

Young chronicles the obstacles put in place by Health Canada. In order to access data, Health Canada requires researchers to sign confidentiality agreements. A Maryland researcher challenged the rejection of his application:

“On July 9, Justice Sébastien Grammond of the Federal Court ….ordered the data released for several reasons, including contradicting the purpose of Vanessa’s Law — to improve clinical-trial transparency — and for failing ‘to assess the effects of its decision on [researcher] Mr. Doshi’s freedom of expression,’ as guaranteed in the Canadian Charter of Rights and Freedoms.

“Health Canada breached the Charter. Yet the offending policy is still posted on its website three months later.”

So what was going on as parliamentarians passed Vanessa’s Law?  Were people deep in the bureaucracy at Health Canada quietly reassuring Big Pharma?

“Don‘t worry, we have your back,” they whispered. “Parliament may think it can expose your secrets to protect the health of Canadians, but we’ll strangle their naïve zeal in implementation.”

Why do we enter trade agreement after trade agreement expanding the profit margins of Big Pharma?

Why do we allow drug companies to enjoy obscene profit margins that increase the strain on our health care system?

How are we blind to the impact of having two and a half drug salespeople for every physician in Canada?

And what the hell is going on in thwarting the will of parliament by blocking Vanessa’s Law?

Health Canada needs to be shaken by its ankles until the answers come tumbling down. I’ll bet anything that this intransigence is not being directed from the Minister’s office.  This is a captive regulator working for Big Pharma.

Originally published in the Hill Times on November 14th, 2018.