Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

A report released yesterday underlines the danger of Trasylol (aprotinin), which was used for years to limit bleeding during surgery. Trasylol was taken off the market last year after U.S. tests indicated the drug posed a significantly higher risk of death as opposed to other anti-bleeding drugs.

The new study, as reported by Forbes.com, includes an examination of Trasylol use in 49 randomized clinical trials, and also includes new information from the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study, published earlier this year. The findings of the new study, which was conducted by Canadian and Australian reserachers, will be published in the Jan. 20 issue of the Canadian Medical Association Journal.

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Zero accountability for drug companies?

Bloomberg recently ran an article about pharmaceutical companies enjoying their “get out of jail free cards” — revisions to regulations that favor the rights of pharmaceutical companies over consumers who use their drugs. The revised regulations, written just after George W. Bush’s second inauguration in 2005, allow federal law to trump state law, thereby clearing the path for drug manufacturers to develop, test, market, and essentially do business with impunity from the law.

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Bloomberg recently ran an interesting and comprehensive article about pharmaceutical companies enjoying their “get out of jail free cards” — revisions to regulations that favor the rights of pharmaceutical companies over consumers who use their drugs. The revised regulations, written just after George W. Bush’s inauguration in 2005, allow federal law to trump (or pre-empt) state law, thereby clearing the path for drug manufacturers to develop, test, market, and essentially do business with impunity from the law.

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The Food and Drug Administration sent Bayer Health Care official warnings, stating that the company is marketing and selling two over-the-counter medications that are “illegal,” according to FDA spokeswoman Rita Chappelle.

The two aspirin products, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage, are misbranded, mislabelled, and confusing to consumers, according to the FDA.

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Two Illinois residents have filed suit against Bayer, claiming that Trasylol injections led to acute renal failure and other problems in one case and death in the other.

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Attorneys who take on the pharmaceutical industry as a voice for consumers injured by medications found an unlikely ally this week, in doctors. Noting that the U.S. Food & Drug Administration is often “overwhelmed” by drug safety problems ranging from serious side effects to unsafe manufacturing facilities, editors of the New England Journal of Medicine said patients benefit from information uncovered by attorneys during liability investigations, according to an Associated Press report released Friday.

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Bayer AG suspended worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons.

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A conclusive study of Bayer AG’s aprotinin injection Trasylol uncovered a grim fact: one out of every 50 Trasylol recipients dies. The study was conducted in Canada and involved monitoring the health of 2,331 high-risk heart patients.

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The FDA announced today that Bayer Pharmaceuticals Corp. will begin removing all remaining supplies of the drug Trasylol (aprotinin) from warehouses and other medical stock. The decision comes following the preliminary results of a test that showed the drug greatly increased the risk of death. Trasylol is administered to patients undergoing heart surgery to slow bleeding and reduce or eliminate the need for blood transfusions.

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An article in this week’s Business Week reveals a dualistic Bayer. On one hand, the pharmaceutical giant is “flush with success,” with projected sales just shy of $50 billion and increased dividends for shareholders. On the other hand, Bayer has been racked by a sequence of bad luck that threatens to sully its future fiscal health and innovation. What are the elements at work behind this dichotomy?

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