After a cabinet shuffle in Ottawa last week, former Conservative MP Terence Young is calling for the new health minister to personally review a drug safety law that he is criticizing Health Canada for watering down.
Young helped spearhead what has been dubbed Vanessa’s Law, a robust drug safety law passed without dissent in Parliament and the Senate in November 2014.
The bill helps protect Canadians by making it mandatory for health-care institutions to report all adverse drug reactions in patients to health regulators, among other things. These dangerous drugs could then be taken off the market.
But Young, who lost his seat in the 2015 election, says Health Canada is diluting the powers of the bill by not requiring all health-care facilities to report incidents of adverse drug reactions. He is calling for new Health Minister Ginette Petitpas Taylor to take a close look at the issue because Canadian lives are at stake, he says.
“The new minister is going to have to direct Health Canada and going to have to intervene, and it has to happen soon because the regulations that Health Canada is proposing would gut the bill and send us back 10 years in drug safety,” Young says.
The issue is personal for Young. He lost his 15-year-old daughter Vanessa, who inspired the name of the bill, when she died of a heart attack in 2000 after taking a prescription drug to treat a mild form of an eating disorder.
Since the tragedy, Young has been on a mission to increase drug safety in Canada, and he thought his work was done when the bill was passed. He points to documents released by Health Canada this summer as evidence that Vanessa’s Law is not being properly implemented.
“Now it’s been two-and-a-half years and Health Canada has done nothing to enforce it. They have two white papers out and a guidance document, which undermine the powers that are given to Health Canada and the Ministry of Health to get risky or unsafe drugs off the market,” he says.
Overall, Health Canada has a “dismal track record” with drug safety, says Young, noting that since 1990, 22 drugs have had to be taken off the market for injuring or killing patients. The drugs were all deemed safe by the federal health regulator and pharmaceutical companies.
He says adverse drug reactions are a leading cause of death in Canada, claiming between 10,000 and 20,000 lives annually. Given that that figure comes from a 19-year-old study led by the University of Toronto, it’s expected the number of deaths could be even higher.
A 2011 Health Council of Canada study suggests that an estimated 150,000 patients experience serious reactions from prescription drugs each year, which demonstrates why Young wants more done from the top levels of government to enforce Vanessa’s Law and increase safety for patients.
“The prime minister promised in the last election that the government would be transparent, but this is the opposite of transparency,” he says. “This is allowing the pharmaceutical companies to hide the data critical to protecting Canadians.”
When contacted for comment, Health Canada issued a statement saying it is committed to implementing Vanessa’s Law.
“Health Canada sees the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) as an essential safety measure to protect Canadians and is fully committed to its implementation. This legislation is an important tool to strengthen product safety and surveillance and ultimately to protect the health of Canadians,” the statement reads.
But Young maintains Health Canada is limiting the amount of data on adverse drug reactions by not including reports from long-term health care facilities, community clinics, and pharmacies. This approach, he said, won’t paint a clear enough picture to get dangerous drugs off the market in a timely manner.
With seniors being the group most likely to be affected by adverse drug reactions, it would only make sense to include reports from long-term care facilities as a priority, he says.
‘Patchwork of inadequate reporting’
According to Young, only one percent of all adverse drug reactions in Canada end up getting reported.
“What we’ve had is a patchwork of inadequate reporting of adverse drug effects in this country, and it leads to deaths, and that’s not an exaggeration,” says NDP Health Critic Don Davies.
Davies also sees reason for alarm with the way Health Canada is enforcing Vanessa’s Law. He says the documents it released indicate it is going in the direction that would limit the breadth and reach of the bill to a point where he’s worried whether it would be effective at all.
“To me, the essence of good policy is solid data, and we should be seeking to broaden the database not truncate it—particularly when lives are at stake,” he adds.
Both Davies and Young say they believe the reason behind the weakening of the bill could be pushback from pharmaceutical companies as well as from bureaucrats due to the increased workload of added administrative requirements.
David Lee, chief regulatory officer at Health Canada, told Global News the administrative burden on hospital staff and the usefulness of the data should both be taken into consideration with implementation of the new regulations.
“We’re trying to get safety information about drugs, but we also have to remember it’s a hospital. And so you want the health-care professionals spending their time on care,” he said.
But Davies said keeping Canadians safe should be Health Canada’s top priority.
“I would rather err on the side of administrative burden than on the side of people dying from adverse reactions,” he says, adding that he will make the enforcement of Vanessa’s Law a priority when Parliament resumes in the fall.
As well as making it mandatory for health-care institutions to report adverse drug reactions, Vanessa’s Law imposes stiffer penalties on unsafe products and enables quicker regulatory action such as a product recall or label change. It also seeks to add transparency by making it mandatory for drug companies to release their clinical trial data collected when a drug is first being tested for independent researchers to use. This would be a fundamental change to Health Canada’s longstanding practice of treating clinical trial data as confidential drug company secrets.
“What it’s going to take is for the new minister of health or the prime minister or both to say to the people at Health Canada: ‘We want you to enforce Vanessa’s Law as it’s written and quit trying to undermine the bill,'” says Young.
“‘We want all serious adverse drug reactions to be reported to Health Canada and be given the data not two years away, but soon. And we want you to release all clinical trial data to independent researchers and people who work in the public interest, just as Vanessa’s Law says.'”
Jared Gnam is a freelance reporter based in Vancouver. He broke into the world of journalism covering the Stanley Cup Riot in 2011.