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Study Challenges Alarmism About Drug Safety in Canada

TORONTO, ONTARIO -- (Marketwired) -- 02/13/14 -- A new study published by the Canadian Health Policy Institute (CHPI) challenges alarmist claims about drug safety in Canada.

In a recent article published in the journal Open Medicine ("How safe are new drugs? Market withdrawal of drugs approved in Canada between 1990 and 2009"), author Joel Lexchin examined the issue of drug safety in Canada finding that 22 drugs had been withdrawn from the Canadian market for safety reasons between 1990 and 2009. Lexchin suggested that Health Canada is too quick to approve new drugs, and raised doubts about the rigour of the drug safety evaluation and surveillance system in Canada. Lexchin later warned patients against using new drugs until 3 years after they are approved by Health Canada.

Dr. Nigel Rawson (Ph.D.) re-examined the evidence on which Lexchin's conclusions were based. He found that Lexchin overstated the number of withdrawals for safety reasons because 3 of the drugs were withdrawn for reasons unrelated to safety.

Using available data, he also looked at how long it took Health Canada to approve 17 of the 22 drugs examined by Lexchin and compared this to the drugs that were not withdrawn. Rawson found that contrary to Lexchin's claims, there was no evidence that Health Canada was quicker to approve the drugs that were withdrawn for safety reasons versus the drugs that were not withdrawn.

Further, Rawson's analysis of new drugs approved in both Canada and the United States between 1992 and 2011 showed that approvals took longer in Canada than in the United States for many drugs, yet the longer approval times were not associated with better statistics on drug safety: the proportion of approved drugs that were subsequently discontinued for safety reasons was the same in both countries.

Dr. Rawson concludes that there is no evidence to indicate a lack of rigour in Health Canada's drug safety review and monitoring systems.

The study was published at CHPI's free access online journal, Canadian Health Policy at www.canadianhealthpolicy.com.

About CHPI

Canadian Health Policy Institute (CHPI) is a non-profit think-tank funded by independent research grants and unrestricted operating grants from public sector, private sector and non-profit sector sources. CHPI is dedicated to conducting, publishing and communicating evidence-based socio-economic research on health system performance and health policy issues that are important to Canadians.

Open Access Permission

CHPI grants open access permission to republish this news release in whole or in part for use in news articles as long as references to Canadian Health Policy Institute (CHPI) as the publisher and Dr. Nigel Rawson as author are included.

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