German government attacks Bayer over handling of Baycol withdrawal

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BERLIN (Reuters) – The German government on Thursday criticised Bayer AG for waiting too long before telling patients about the dangers of cerivastatin (Baycol/Lipobay) and said it wanted to improve the way companies report problems with their drugs.

Health Minister Ulla Schmidt said the government would set up a group of doctors and chemists to examine ways to make medicines safer. Schmidt criticised Bayer for having informed investors about the withdrawal of the drug before telling either the patients or the German government.

Bayer said in a mandatory stock market statement on August 8 that it was withdrawing Baycol–known as Lipobay outside the United States–worldwide, except for in Japan, due to potentially fatal side effects. Word of the Japanese withdrawal came on Thursday.

German law states that companies must make public all developments that could affect their share price. Bayer has repeatedly said it notified doctors and pharmacists as quickly as it could, posting the withdrawal statement on the Internet as soon as it was announced and holding a conference call with the media 2 hours later.

Schmidt said the government would examine ways to ensure that companies in future inform patients at the same time as they tell investors about problems with drugs they make. "The Lipobay case shows that we must examine this issue," Schmidt told reporters.

Rhabdomyolysis, one of the side effects of Baycol/Lipobay, has been particularly notable among patients treated at the same time with another cholesterol-lowering drug, gemfibrozil. Japan had initially been omitted from the worldwide withdrawal of Baycol/Lipobay because gemfibrozil had not been marketed there. But Bayer said on Thursday that it had now been informed by the Japanese health authorities that gemfibrozil would soon be registered there.

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