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A rack of pharmaceuticals sit in a pharmacy , March 11, 2010. (J.P. Moczulski/The Globe and Mail/J.P. Moczulski/The Globe and Mail)
A rack of pharmaceuticals sit in a pharmacy , March 11, 2010. (J.P. Moczulski/The Globe and Mail/J.P. Moczulski/The Globe and Mail)

Critics decry change in drug-approval process Add to ...

British Columbia's widely applauded independent drug-approval process is being dramatically altered to make room for more input by pharmaceutical companies, a change decried by critics as potentially harmful to consumers, a conflict of interest and likely to increase spending on drugs.

An internal health ministry document says there will now be four separate opportunities for drug marketers to make their case while new products are being considered for coverage by B.C.'s PharmaCare plan.

At the same time, the government's long-standing drug review body with an arms-length distance from the industry is being abolished. The Therapeutics Initiative's cautious approach to drug approvals has been credited with saving lives and helping B.C. maintain the lowest per capita spending on prescription drugs in the country.

Michael McBane of the Canada Health Coalition said no other provincial drug plan allows as much industry involvement as B.C. is proposing.

"It's unheard of," Mr. McBane said Tuesday, on the eve of a closed-door meeting with industry stakeholders to discuss the changed approach. "This is a corruption of the drug-review process. It's just not done. This moves B.C. from the best drug-review process in Canada to the worst."

While a government-appointed review panel will still make final decisions, Mr. McBane likened the numerous chances for drug companies to provide input to asking car salesmen whether one should buy one of their cars or go to another model.

"It's a conflict of interest. It will also speed up the process, and that is inherently risky."

Health Minister Kevin Falcon was unavailable for comment, but a ministry spokesman said the altered approach is designed to provide more industry feedback during the drug-approval process to avoid having questions left unanswered at the end.

"It just makes sure the whole process is complete," he said.

Russell Williams, president of Rx&D, representing the Canadian pharmaceutical industry, said the revamped approval process is designed to provide people in B.C. with better access to "lifesaving and life enhancing new medicines. Let's hope that the new review process will bring more innovative medicines more quickly to British Columbians.

"The improvements in process are designed to increase transparency and we support this approach," said Mr. Williams, in an e-mailed statement.

James Wright, co-managing director of the Therapeutics Initiative, which allows only bare-bones industry input when considering approval of new drugs, said the TI's goal is to rely on objective information.

"If a drug company has new information, fine, but otherwise, their opinion or critique doesn't help the process because it is not independent," Mr. Wright said. "They are conflicted."

Alan Cassels, a pharmaceutical policy researcher at the University of Victoria, said the change gives even more weight to already powerful drug companies.

"This gives them four more kicks at the cat. But who's the client here? It should be the consumer who pops a pill into their mouth, not the companies wanting to make sales," Mr. Cassels said.

Often cited as an example of the Therapeutics Initiative's value is its reluctance to approve the arthritis drug, Vioxx, eventually pulled off the shelves after tens of thousands of deaths were attributed to its use in the United States. TI researchers had discovered potentially lethal side-effects from the drug while combing independent studies.

"They might have saved 500 lives," Mr. McBane said.

New drugs have also been left off the province's formulary, after the TI concluded they provided little added value for their higher price.

Mr. McBane noted that B.C.'s per-capita spending on drugs is currently 27 per cent less than the average level in the rest of the country. "By weakening independent review and going to a more marketing-based process, costs are likely to go up to where everyone else is."

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