ARE Canadians about to be turned into guinea pigs for testing drugs? Or will they be blessed with a pioneering system of 鈥渟mart鈥 regulation that sweeps aside the usual obstacles between new drugs and patients?
The only certainty is that the Canadian government鈥檚 Food and Consumer Safety Action Plan, discussed in parliament on 8 April, is dividing opinions within Canada and beyond.
The plan鈥檚 so-called 鈥減rogressive licensing鈥 system will break new ground by streamlining the usual requirements for proving that a drug works and is safe before approval. But the quid pro quo is that once a drug is approved, pharmaceutical companies will be obliged to continue tracking it forever.
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One justification is that exposing the entire population to a drug will reveal adverse reactions and rare effects in groups such as children faster than through traditional clinical trials. Some think this is reckless, though. 鈥淚t鈥檚 turning the Canadian population into guinea pigs,鈥 says Michael McBane of the Canadian 91色情片 Coalition in Ottawa, Ontario. James Wright of Columbia University, New York, doubts whether relying on drug firms to report adverse events will protect people.