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Germany slams Bayer for sitting on drug danger warning
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August 16, 2001 Thursday

The German government blasted the drug group Bayer on Thursday for failing to tell health authorities for nearly two months that its top-selling anti-cholesterol treatment could have lethal side effects.

Health minister Ulla Schmidt ordered a probe of the chemicals and pharmaceuticals corporation when it was forced to pull Lipobay/Baycol from the market last week. The drug has been linked to the deaths of 52 people.

In an inquiry completed by the Federal Institute for Pharmaceuticals and Medical Products (BFARM), the authority found that Bayer had withheld the results of a study it received June 15 showing possibly dangerous side effects of Lipobay/Baycol until August 10, two days after the drug was withdrawn.

The report came amid a welter of bad news for the company that created aspirin, prompting the firm to announce Thursday that it would delay a Wall Street share listing scheduled for September 26 until February 2002.

"The conditions for our entry into the (New York) stock market have been profoundly altered over the course of the last few days," group chairman Manfred Schneider said.

Bayer's capitalization has shed more than 25 percent of its value since the drug was withdrawn, in part because of the threat of hundreds of lawsuits that have been announced in the United States and Germany.

Meanwhile Italian justice officials announced a probe into top managers of Bayer's Italian unit to ascertain whether the medication was withdrawn from markets in time and to look into the cases of 17 Italians who took the drug and have reportedly also been suffering from side effects.

Germany's deputy health minister Klaus Theo Schroeder told reporters while presenting the government's findings that the company would have to face "logical consequences" as a result of its "unacceptable information policy".

"We would have expected that a company would live up to its particular reponsibility for people's health and have the appropriate sensitivity to inform those affected in time," he said.

Germany requires companies to report knowledge of serious side effects of a medication or possible reactions with other pharmaceuticals within 15 days.

Failure to do so can result in a fine of 50,000 marks (25,600 euros, 21,900 dollars), an amount which Schroeder acknowledged at a news conference was insufficient.

BFARM director Harald Schweim said that the institute had now been informed that 92 Germans using the drug have reported serious side effects, of which seven people had died.

Of the seven, Schweim said, BFARM saw a possible causal link to the drug in three cases.

Bayer said Thursday that it had no prior knowledge of potentially dangerous side effects of the medication when it launched the product in 1997, based on tests legally required for market release.

A company spokesman sharply dismissed the government's charges of secrecy and said it would vigorously defend itself against planned legal action.

He said that all relevant information on the subject had been presented to the BFARM in April and that it had filed a report to the appropriate European authorities in June.

The spokesman added that there was no proof of a direct causal link between use of Lipobay/Baycol and the fatalities and only constituted suspicion.

Schroeder said the health ministry now proposed a range of reforms to better protect public health including improved communication about the side effects of pharmaceuticals with countries outside the European Union.

He added that the German government needed to create an "efficient early warning system" in cooperation with the regional states when concerns about a medication arose.

Schroeder also criticized a new European Union guideline that requires firms to inform only national authorities about possible dangers of product, which he said created unacceptable bureaucratic delays in informing the public and beginning an investigation.

Germany has filed a complaint with the European Court of Justice over this measure.