03/03/2003

Some Bayer officials were worried about growing reports of deaths associated with the company's anti-cholesterol drug 18 months before it was pulled from the market, newly disclosed company documents show.

"So much for keeping this quiet," Patricia Stenger, a manager in Bayer's scientific affairs unit, told other executives in a February 2000 e-mail.

Bayer was then seeking critical approval from regulators to sell its Baycol drug at doses double those permitted in order to increase the drug's effectiveness and its sales, documents from lawyers suing the company show. The Food and Drug Administration gave its approval in July 2000.

In a second Stenger e-mail, in June 2000, an attached document says doctors who reported problems were hearing of similar cases. They "appear to be more angry and concerned and feel that Bayer is hiding information," the attached document says.

Bayer pulled Baycol off the market in August 2001, because the higher 0.8 milligram dose was associated with a rare but sometimes fatal muscular disorder that can damage kidneys and other major organs.

The FDA said reports of deaths were most frequent at higher dosages and when Baycol was used in combination with other drugs. Since, Bayer has said that Baycol has been associated with about 100 deaths and 1,600 illnesses worldwide.

The documents were made public Friday by lawyers for a Corpus Christi man, Hollis Haltom, 82, who says he became sick with the disorder rhabdomyolysis after taking Baycol. The lawsuit is the first of possibly thousands to reach trial over the drug.

Other anti-cholesterol drugs also have been linked to rhabdo, but not at the rate reported for Baycol.

Bayer attorney Philip Beck said Sunday that Bayer reported all deaths and illnesses to regulators. "There was never any effort to keep that sort of thing quiet," he said in response to Stenger's e-mail.

The documents disclosed Friday also show that Bayer executives worried about studying possible side effects of the drug because any results would have to be reported to the FDA in the months leading to its decision about the higher dosage.

"Some are scared to uncover such data (bad data) because of launch of 0.8 mg.," one executive, who is not identified, wrote on a January 2000 meeting agenda. "If FDA asks for bad news, we have to give, but if we don't have it, then we can't give it to them."

Under questioning by Haltom's lawyer, Bayer's head of worldwide regulatory affairs, Lawrence Posner, testified Friday that if a study were important to safety, it would be unethical not to pursue it -- even if it produced negative results.