Health Canada prescription drug info should be released, Halifax lawyer says

An associate professor of medicine at Dalhousie University is spearheading a push to make more information about prescription drugs available to doctors, researchers and the public. 

Matthew Herder is a lawyer and associate professor at the university's Health Law Institute. He says what prescription drug information the public knows is just the tip of the iceberg — and there's a new tool in Canadian law to help make that information available. 

"Roughly half the information that's available about whether drugs work or whether they're safe never makes the light of day," Herder said. 

"We want our health-care professionals and others, researchers in particular, to be making sense of that data for us so we can make really informed decisions." 

Too many restrictions

In late 2014, the Protecting Canadians from Unsafe Drugs Act — or Vanessa's Law — was passed. It gives the health minister discretion to release information upon request to people who promote or protect human health.

"I think it should be fairly broad, to include researchers and investigative journalists, to try and help the regulator with the work of screening for drugs and whether they're really safe and really effective." 

Vioxx, an arthritis painkiller that was on the market from 1999 to 2004, is a good example of when that undisclosed information would have made a difference, he says. 

"Then people really realized that there were a lot of heart attacks." 

The increased risk of heart attacks was actually "known to the regulator and the company," but not to the public.

That's Health Canada's jurisdiction, he says, but they "don't always do the perfect job." 

"At the end of the day, we're talking about resources and there's enough examples, enough sort of tragic cases of harm that could have been avoided, that we want other people scrutinizing that data as well." 

'I'm worried'

"Only one physician has tried to take advantage of that [new tool] so far," Herder told CBC Halifax's Information Morning. 

A Toronto doctor asked Health Canada for information about a morning sickness drug, he says, and was asked to sign a non-disclosure agreement preventing him from sharing his findings with colleagues or academic journals. 

The doctor has said he received a threatening letter from Health Canada, warning him not to disclose new information about the drug, Herder said.

"What I'm worried about is it will use that as a model going forward."

Herder wants transparency, but he also wants Health Canada to stop protecting the information for confidential business-use only. 

"I think Health Canada should be saying 'Thank you,' for people who are actually doing this extra work," he said. 

"This should be understood as clinical information that patients originally helped generate by participating in those studies." 

'Overwhelming' response 

If more doctors and researchers make use of Vanessa's Law, then Health Canada can be encouraged to shift its focus fundamentally. 

"I want to make it really easy to do that," Herder said. 

He's made a template letter available online that "physicians and others can use to sort of fill out — what drug are they interested in, why do they think they fulfil the role of a person who protects and promotes human health." 

He's not sure if Health Canada will listen, but strength is in numbers. He says he's encouraged by the amount of positive feedback he's received about his efforts. 

"It's been overwhelming," he said.