Healthy Skepticism Library item: 733

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Fuhrmann , M .
Health Canada defends drug-approval process, denies 'built-in bias'
Canadian Press 2005 Jan 5

Full text:

Health Canada officials defended the government’s drug-approval process Wednesday following harsh criticism of the agency in the country’s leading medical journal.

An editorial in the current edition of the Canadian Medical Association Journal says the department has “a built-in bias” to approve new drugs without adequate assurance of their safety. “The bar for approval is low, requiring only that the (drug) be more effective than placebo,” the editorial says.

The painkiller Vioxx was withdrawn from the market last fall because it doubled patients’ risk of heart attack and stroke. It had been approved in
1999 despite the known potential for cardiovascular problems associated with similar drugs, the editorial said. “There was no need to fast-track approval” of Vioxx, it said.

But Dr. Karen Dodds, acting associate assistant deputy minister at Health Canada, said in an interview that “there’s no built-in bias.”

“We vigorously assess the safety, efficacy and quality of all medications before approving them for use in Canada.”

She said there was no fast-track approval of Vioxx in this country – “and we do not have something called a fast-track approval.”

Dr. Robert Peterson, director-general of Health Canada’s therapeutic products directorate, said the bar for approval of a drug for sale in Canada is “the same as it is internationally.”

Simply working better than a placebo is “not the only basis” for approval, he said. There must “the demonstration of benefit that is far in excess of any risk of the product.”

Dodds disagreed with the editorial’s statement that Health Canada and its U.S. counterpart, the FDA, “put their emphasis and resources into assessing drug benefits, not harms.”

Before Health Canada approves any drug, she said, “the first hurdle is safety.”

“All of these drugs have to pass a safety hurdle even before we’re looking at efficacy.”

The journal argues that once a drug gets approved there presently is no effective way of finding out how much harm it’s doing. There is “only a fragmentary and underfunded mechanism” based on doctors’ reports of adverse events, the editorial says, adding that “an active surveillance system”
would have sounded the alarm on Vioxx much earlier.

But Dodds said “all of the post-market surveillance systems internationally failed to pick this up.”

“There are challenges with post-market surveillance,” she acknowledged.
Health Minister Ujjal Dosanjh has said he is committed to bringing in a system of mandatory reporting of adverse reactions from doctors.

Health Canada, working with doctors and the pharmaceutical industry, needs to find “sensible ways to proceed and to improve the system,” Dodds said.

The journal also criticized what it called the current emphasis at Health Canada and the FDA on “partnerships with industry and rapid drug-approval.”
This emphasis “conflicts with the public’s expectation that these agencies exist to protect them by restricting approval to drugs that have been thoroughly tested and are likely to be free of serious risks.”

But Dodds said “we certainly don’t speak of partnering with industry. We review industry submissions. . . . There isn’t a default that we will approve. We have a responsibility to review all of the information that industry brings to us in a submission.”

As for being too quick to approve drugs, Dodds pointed out that the government usually faces the criticism that it is too slow.

“There is obviously interest in the timeline it takes us to come to a decision,” she said. “We have worked to eliminate our backlog, which is certainly helping us to achieve our performance times.”