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John Ghezzi
John Ghezzi
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Profits Over Safety: Pharmaceutical Giants Still Not Getting the Message

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How many people must be killed, maimed or injured by pharmaceutical drug companies before the manufacturers stop emphasizing profits over safety? Late last month, Bayer Corporation issued a statement admitting that “it mistakenly did not inform” the Food and Drug Administration (FDA) of the results of a contract research study that Bayer commissioned on its heart surgery drug Trasylol. The large study (some 67,000 patients) suggested that the widely used drug might increase the risks of heart attack and strokes.

Trasylol is administered to patients before surgery to reduce the risks of blood loss. It can also reduce the need for transfusions in patients undergoing heart bypass surgery. Two other recent studies involving Trasylol concluded that use of the drug may increase the risk of serious outcomes such as kidney failure, heart attack and stroke. In January 2006, the New England Journal of Medicine (NEJM) published a study that revealed use of Trasylol significantly increased the risk of renal failure involving dialysis, myocardial infarction and stroke. The study named two less expensive generic medications as safer alternatives.

Bayer’s excuse for failing to immediately disclose the results of the study? The results were “preliminary in nature.” Shockingly (or perhaps not so much), Bayer scientists stood mute at a September 21 public meeting convened by the FDA to assess the dangers associated with Trasylol. After all, the drug is one of Bayer’s top sellers generating $200 million dollars in revenue in 2005 and likely exceeding $600 million in 2006.

Earlier this year, we learned that Merck, the manufacturer of Vioxx, had suppressed data for a study published in the New England Journal of Medicine. Those of us experienced in pharmaceutical litigation know that these two instances of data suppression are not isolated lapses in judgment. This is conscious immoral (and possibly unlawful) behavior by drug companies that puts consumers at risk of serious bodily injury for nothing more than money grubbing profit motive. The public should be justifiably outraged at this latest irresponsible corporate behavior. Apparently large jury verdict awards alone are insufficient to deter the drug companies from failing to disclose studies or manipulating data. It is imperative that consumers support recent bills calling for legislation that requires drug companies to register all human drug trials with the FDA and publicly disclose all results of these studies.