Monday, July 12, 2010

HEALTH - Drug Manufacturing Regulation

"Caustic Government Report Deals Blow to Diabetes Drug" by GARDINER HARRIS, New York Times 7/9/2010

Excerpt

A federal drug official on Friday dealt a severe blow to the popular diabetes drug Avandia, issuing a scathing review of a major clinical trial that its manufacturer has been using to argue that the drug was safe.

The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s tally of adverse events.

Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” Dr. Marciniak wrote.

The detailed report could prove crucial next week, when a panel of experts will meet to consider whether to recommend to the F.D.A. that the manufacturer, GlaxoSmithKline, withdraw Avandia from the market or restrict its sale.

The panel’s decision will have broad consequences for the company, the F.D.A. and perhaps even the entire process by which medical products are approved. The agency almost never does clinical trials on its own, depending on drug companies to conduct them appropriately.

Questions for GOP: So we are just to trust the drug manufacturing industry, and more regulation would hurt the American PEOPLE? These corporations are MORE important than individual lives?

I am a diabetic, but I do not take Avandia but having said that, message to GOP... my life (or anyone's) is MORE IMPORTANT that GOP Dogma and these corporations.

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