Health Canada 'silent' on drug safety decisions

Health Canada is too secretive about how it evaluates new medications and devices compared with the U.S., a medical journal editorial says.
When the FDA decided to pull its approval of the drug bevacizumab (Avastin) for breast cancer, it produced a podcast to explain its position, but Health Canada is silent about post-market research for the drug. (Genentech/Associated Press)

Health Canada is too secretive about how it evaluates new medications and devices compared to the U.S., a medical journal editorial says.

The "open government" strategy that Prime Minister Stephen Harper announced on Friday will be hard to implement when it comes to Health Canada and the Public Health Agency of Canada, this week's editorial in the Canadian Medical Association Journal says.

Unlike U.S. President Barack Obama's directive, Canada's strategy is piecemeal, with no imperative to ensure easier access to information, said Dr. Paul Hébert, the journal's editor in chief.

The federal announcement "looks [like] nothing more than marketing and pre-electioneering," Hébert said.

Hébert said Health Canada operates in a culture of secrecy that will be hard to change.

The editorial points to lack of transparency at Health Canada, such as:

  • Research evidence and details of company submissions to launch new medications and devices are not publicly available.
  • Health Canada does not announce dates for approval hearings, provide relevant information or offer the public reasons for its decisions. In contrast, the U.S. Food and Drug Administration announces topics, post timetables, invites public submissions and provides clear and transparent rationale for its decisions to grant market approval for a new drug.
  • Health Canada does not yet require companies to register clinical trials. U.S. legislation ensures clinical trials are publicly registered and the results posted on a database to prevent companies from hiding negative results.

The result is that when it comes to drug approval or safety issues, the people who actually prescribe the drugs are left in the dark, Hebert said.

 Closed-door meetings

"Committees meet, you don't hear about it, you don't even know they're happening," he  said. "They make decisions behind closed doors that are never released and you don't know their rationale."

When the FDA decided to pull its approval of the drug bevacizumab (Avastin) for breast cancer, it produced a podcast to explain its position. Health Canada still "remains silent on recent post-market research involving this drug," the editorial noted. 

Health Canada defends the secrecy in the name of protecting the proprietary interests of drug companies and device manufacturers.

But even to get information used to make public policy decisions, researchers and health advocates say, it now routinely takes years.

"It shouldn't be incumbent on me or you to try to essentially be private investigators with the information that's collected by public servants on behalf of all Canadians," said Bill Jeffery, national co-ordinator for the Centre for Science in the Public Interest, a group in Ottawa that advocates for nutrition and food safety.

More openness would give Canadians the opportunity to see how government sets its priorities and spends funds. People should be able to know if a program costs millions and saves only one or two lives, or if a relatively small amount of money saves hundreds of thousands of lives a year, Jeffery said.

When CBC News asked Health Canada for its reaction, a spokesman said it would need more time to respond.

With files from CBC's Pauline Dakin