The Pharmaceutical Journal
Vol 273 No 7328 p807
4 December 2004

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Bayer could have acted more swiftly over Lipobay

Bayer could have acted in a more timely fashion over the withdrawal of its lipid-lowering drug cerivastatin (Lipobay) in 2001, authors of a review have suggested.

They add that the company was subject to an “almost insurmountable conflict of interest” (JAMA 2004;292:2622). Bayer has refuted these claims.

The review concerned use of cerivastatin and the associated risk of rhabdomyolysis — a rare condition in which skeletal muscle cells break down causing pain, weakness and, in some cases, renal failure and death.

Bruce Psaty, of the cardiovascular health research unit, Seattle, Washington, and colleagues used rhabdomyolysis incidence data to track events leading to the drug’s withdrawal. Some data were published but others became available only after coming to light during litigation.

The authors confirm the increased risk of rhabdomyolysis associated with cerivastatin and that the highest risk was for patients treated with concurrent gemfibrozil. They also suggest that Bayer was aware of these risks as early as four months after the launch of cerivastatin. “Opportunities were missed at several stages to undertake prompt and thoughtful medical and scientific responses to the [suspected adverse drug reaction, SADR] findings,” they say.

They also point out that with five other statins on the market, an earlier suspension of cerivastatin sales would not have deprived prescribers and patients of effective lipid-lowering therapies.

The authors suggest that appraisal of SADRs by pharmaceutical companies may be influenced by economic considerations as well as the emotional investment of those involved in the development process. “When serious, even rare, SADRs such as rhabdomyolysis are detected, pharmaceutical companies have a complex and almost insurmountable conflict of interest in weighing and interpreting the risks and benefits of various courses of action,” they say.

In the same issue of JAMA, Joseph Piorkowski, a “physician-attorney”, responds on behalf of Bayer (ibid, p2655). He points out that the company “complied with its disclosure obligations”.

“It always is possible to second guess decision-making after the fact … Bayer’s conduct in the marketing of cerivastatin from 1997 until its voluntary withdrawal from the market in August 2001 was responsible, appropriate, and consistently motivated by concern about the safety and welfare of patients,” he concludes.