From Blacklock’s Reporter: “Shameful”: Health Canada Broke Law, Fed Judge Rules
A federal judge has ruled Health Canada breached its own drug safety law. A former Conservative MP who sponsored the 2014 legislation yesterday described the department’s misconduct as shameful.
“The government talks about transparency and evidence-based decision making, and it was all a façade,” said Terence
Young, former MP for Oakville, Ont. “They were in Federal Court fighting against transparency. They still don’t get it at Health Canada. This is a farce.”
The Federal Court ruled the department improperly attempted to conceal pharmaceutical companies’ clinical trial reports sought by a researcher, though disclosure was permitted by Bill C-17 An Act To Amend The Food & Drugs Act. The legislation was named Vanessa’s Law for Young’s daughter, a 15-year old schoolgirl who died of heart failure in 2000 after being prescribed Prepulsid for a digestive disorder. The Johnson & Johnson drug was ordered off the market five months after her death.
“This is the first case in which the courts are called upon to interpret and apply Vanessa’s Law,” wrote Justice Sébastien Grammond; “Health Canada’s blanket confidentiality policy is unreasonable. It ran against one of the purposes of Vanessa’s Law. It had the effect of perpetuating the mischief against which Vanessa’s Law was aimed. Quite simply, Health Canada cannot ignore that Parliament intended to make clinical trial data public and adopt a policy that is in direct contradiction with that purpose.” Bill C-17 allowed the health department to “disclose confidential business information about a therapeutic product” in the name of public safety, as well as expand cabinet’s powers to recall prescription drugs deemed a risk to health.
The Court ruling followed a 2016 application by a U.S. researcher, Prof. Peter Doshi of the University of Maryland, who cited Vanessa’s Law in seeking “complete copies of all sections of all clinical trial study reports” on five prescription drugs including the vaccines Cervarix and Tamiflu. Health Canada in 2017 refused to release the data unless the Professor signed a secrecy agreement, claiming data were confidential information owned by pharmaceutical companies. Prof. Doshi refused and challenged the gag order.
Justice Grammond upheld the complaint, ruling the health department breached a main purpose of Vanessa’s Law and Prof. Doshi’s constitutional right to freedom of expression. “Publicly disclosing clinical trial results may be beneficial to public health,” wrote the Court. “There are concerns the conduct of those tests may be biased, or that pharmaceutical companies selectively publish results that favour their interests.”
“Health Canada’s decision in this case is unreasonable because it entirely disregards one of the main purposes of Vanessa’s Law, namely to improve clinical trial transparency,” wrote Justice Grammond. The Court ordered staff to release the clinical trial reports. Health Canada does not comment on litigation, and has 30 days to appeal.
‘If They Appeal This – ’
“You had Health Canada, the people who wrote the bill, arguing against the transparency the bill promised,” said former MP Young. “Not only is it embarrassing, it’s wrong. They lost. If Health Canada appeals this, we can kiss patient safety goodbye.”
“This is not transparency,” Young said in an interview. “Health Canada still doesn’t get it. They’re still talking about helping the drug industry; that’s how they interpret their role.”
Young said he suspected Health Canada regulators were influenced by pharmaceutical lobbyists in thwarting the purpose of Vanessa’s Law. “Here’s what I think happened: There are lots of ways to stop a bill, including voting for it and then failing to enforce it,” said Young. “This government was listening to its friends in Big Pharma all along. It is shameful.”
Counsel for the University of Maryland researcher who won the case yesterday did not respond to an interview request. Lobbyists in 2014 testimony at the Senate social affairs committee expressed alarm over the disclosure of “confidential business information” regarding the results of drug trials. “You could be talking about manufacturing information,” said Gerry Harrington, vice president of Consumer Health Products Canada. “That has tremendous commercial value to a manufacturer.” Harrington testified the disclosure of drug safety results would put a “chill” on medical research. “The lack of provisions holding recipients of confidential business information to respect confidentiality is at odds with the practices of our major trading partners,” said Harrington.
Legislators in 2017 also criticized Health Canada for failing to enact provisions of Vanessa’s Law requiring health care institutions to report adverse drug reactions. Records disclose the department held private meetings with lobbyists in 2016 before concluding the reporting requirements were “time-consuming and financially burdensome”.
Former MP Young counted 27 medicines licensed for sale by Health Canada since 1997 that were subsequently recalled due to patient deaths and injuries, including the prescription used by his daughter. “Vanessa’s Law just passed its first test in Court with flying colours,” said Young. “The government needlessly argued in Court against the very transparency it claimed to support, and was slapped down by a federal judge.”
By Tom Korski