Wednesday, September 01, 2010

Not a good day for the Drug Industry (and later update)

Increase in nonfatal heart attacks and stroke with Meridia - and NO change in survival

Contrast with proven survival benefits with surgery - see previous posts and Vancouver Sun article for Diabetes remission (Archives of Surgery source)

UPDATE late October - (now that Meridia is withdrawn from the market)

Qnexa FDA rejection (2 drugs in one week - not much left in "pipeline"

Here's a quote from the end... of the article

"If there isn't any kind of path forward for this drug I think it is going to shut down all obesity drug development for a decade," said Dr. Tim Garvey of the University of Alabama. Garvey conducted two clinical trials of Qnexa and has consulted for Vivus.
"Why would a company put all that investment into developing a drug if the FDA signals they aren't willing to approve it," he said.
With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential.
But the search for a drug that helps patients safely shed pounds has been largely unsuccessful. Two weeks ago Abbott Laboratories withdrew its pill Meridia from U.S. and Canadian markets after regulators said it increased the risk of heart attack and stroke.

The answer is that Phen-Fen had 18 MILLION prescriptions, and made a lot of people money, even if there was ultimately more harm than good out of it... The drug companies will keep trying, as they should, but there is no "silver bullet" - even surgery is not a cure, but a tool.

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