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Drug recalls linked to U.S. testing deadlines

CARLY WEEKS

From Thursday's Globe and Mail

Latest comment posted at 2:40 PM EDT 28/03/08

Constraints compromise regulators' ability to focus adequate attention on safety and efficacy of drugs ...Read the full article

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  1. Daniel Roy from Toronto, Canada writes: Is someone paying any tax money to finance that kind of study reaching such a predictable conclusion? The drugs and drug companies being what they have become these past years, my only advice is to take care yourself of your health, and not rely on some pills!
  2. No Left or Right Just Neutral from Canada writes: Like Daniel said, maintain the body and rely less on these FDA approved(almost) drugs!!!
  3. Brian Marlatt from White Rock, BC, Canada writes: Thalidomide children with flippers instead of arms and legs were the result of American business-first testing in the 1960s. My family's lawyer spent a decade trying to achieve financial compensation for a tragedy that no human compensation could achieve - and even then they had to agree not to reveal details. This is a warning that little has changed south of the border. Sometimes we complain that regulatory approval in Canada is too slow and that Americans get approvals first. Part of this is the result of commercial interests seeking approvals in the more profitable, ten times larger, market first. Part of it seems also to be because making a buck is more important to some than the human cost. This is a warning against calls for regulatory "North American" harmonization and assumptions that "Made in the U.S.A." is a safe standard.
  4. Wayne Spitzer from Faywood, United States writes: Brian Marlatt from White Rock B.C. writes "Thalidomide children with flippers instead of arms and legs were the result of American business-first testing in the 1960s". The truth is that Thalidomide was developed by a German Pharmaceutical company. It was approved for use in the 1960s in Europe and Canada. It was never approved for use in the U.S., as the FDA rejected its approval on the grounds of insufficient safety testing. But what the heck - why should anyone let facts interfere with their prejudice.
  5. Brian Marlatt from White Rock, BC, Canada writes: Actually, the FDA approved use of Thalidomide in 1998. However, I should point out that in the 1960s the actions of a single FDA medical specialist famously crusaded against approval at that time, establishing the FDA's reputation. You are right, however, to point out that the company which developed Thalidomide was German, not American. As for the rest of my comment, it is correct and a matter of record I believe.
  6. Wayne Spitzer from Faywood, United States writes: What the public doesn't realize is that for every death or injury that results from a drug being approved by the FDA too quickly, there are ten deaths or injuries that result from the FDA denying approval or being too slow. The proposal for progressive liscensing of new drugs is a good idea, which may serve to help both sides of the problem.

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