In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.
Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.
But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.
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This case represents typical behavior from drug manufacturers and the Food and Drug Administration. The FDA relies on corporations like SmithKline to test products that it wants to bring to market - the fox guarding the hen house. And fudging data is nothing new.
Several drug manufactures employed a practice known as having a "vice-president who goes to jail." In short, the corporation would promote someone into a position for which they were not qualified, fudge the testing data, and, when caught, offer up the "vice-president" as a scape-goat.
When will we learn that our regulatory model is a failure? It seems that the BP disaster and the near-collapse of Wall Street, along with hundreds of previous examples, has taught us nothing. An estimated 5000 people die each year from eating contaminated food. We don't know the exact death toll from defective products like Avandia, but it exceeds the number of homicides reported in Uniform Crime Reports each year.
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