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4 posts tagged with FDA and pharma. (View popular tags)
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Even better than the real thing?

Widespread fraud has been discovered in the case of an Indian generic drug manufacturer that makes generic Lipitor (atorvastatin calcium) and many other drugs. Ranbaxy has "pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud." [more inside]
posted by fiercecupcake on May 18, 2013 - 28 comments

Psychotropic medication efficacy and publication bias

Antipsychotics: "The magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently."
Antidepressants: "We found a bias toward the publication of positive results. Not only were positive results more likely to be published, but studies that were not positive, in our opinion, were often published in a way that conveyed a positive outcome. [...] Using both approaches, we found that the efficacy of this drug class is less than would be gleaned from an examination of the published literature alone. According to the published literature, the results of nearly all of the trials of antidepressants were positive. In contrast, FDA analysis of the trial data showed that roughly half of the trials had positive results." Previously [more inside]
posted by OmieWise on Apr 3, 2012 - 34 comments

Avastin and the power of hope

Based on a lack of evidence for efficacy, "an FDA panel unanimously voted to revoke its approval of Avastin (bevacizumab) for breast cancer. The decision evoked cheers from some groups and jeers from others. At least one group derided the decision as the work of a 'death panel'". An interesting article on the withdrawal of a "miracle" drug from a section of the market, explaining the reasoning behind the decision and discussing the reaction from patients, many of whom believe -- despite the evidence -- that the drug was actually helping them. [more inside]
posted by metaBugs on Jul 1, 2011 - 11 comments

Race-based pharmaceuticals?

Pharmaceutical company seeks approval for controversial heart drug BiDil for blacks only, even though the connection of a nitric oxide deficiency to the genetic makeup of the African-American population is an unsubstantiated hunch, in the words of the drug's own developer — and the drug had already once been denied approval. Is the FDA doing good science or ignoring science under the pressure of big business wanting to sell BiDil to a US$1Bln demographic?
posted by Rothko on Jun 16, 2005 - 27 comments

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