Bayer executive's testimony in court confirms the company was well aware of the dangers of Baycol

A senior executive at Bayer AG has testified in court that other company executives in the United States recommended against selling the anti-cholesterol drug Baycol several years before it was introduced in 1997 because they thought its sales potential was limited.

(New York Times) -- But Baycol was introduced because executives in Germany, where Bayer is based, decided to push ahead when market conditions improved and the potential for profit looked promising for many years.

Sales of Baycol increased rapidly until Bayer pulled Baycol off the market in 2001 after more than 30 deaths were linked to the drug. The company has been dealing with the aftermath since.

The Bayer executive, Dr. Lawrence Posner, senior vice president for pharmaceutical development, was testifying in county court in Corpus Christi, Texas, on Friday in a case brought by a patient who contracted a muscle disorder called rhabdomyolysis after taking Baycol.

It is the first case involving Baycol to go to trial. More than 10,000 patients or the families of those who died after taking Baycol have filed suits against Bayer.

Posner defended the company for several hours as lawyers for the plaintiff, Hollis Haltom, 82, introduced dozens of internal company documents into evidence.

He said Bayer had monitored reports of rhabdomyolysis, known as rhabdo, in patients taking Baycol and had properly informed doctors about the risks of the medicine as it learned of them.

But several memos from Bayer safety officers in 1999, made public earlier in the trial, describe how its staff was struggling to respond to an increasing number of reports of patients who had become ill with rhabdo while taking Baycol.

In a memo written on Dec. 30, 1999, and addressed to Posner, safety executives said they had received reports of 60 cases of rhabdo in the United States in the previous two months. Doctors and others observing people becoming ill or dying while taking a medicine voluntarily file the reports, known as adverse event reports, with regulators and the drug's manufacturer.

" The steadily increasing numbers of spontaneous reports of rhabdomyolysis associated with Baycol, along with the additional telephone activity, has overwhelmed the available safety assurance resources," the executives, who were not individually identified, wrote.

Bayer did undertake an internal analysis of the reports of rhabdo cases. In March 2000, Steve Niemcryk, an epidemiologist at Bayer, and Paul Cislo, a database analyst, reviewed the reports of rhabdo that regulators received through June 1999.

They said Baycol "substantially elevates" the risk of rhabdo, compared with similar drugs on the market.

About that time, Richard Goodstein, vice president for scientific relations at Bayer, wrote an e-mail message to two dozen Bayer executives working on Baycol in the United States. He said that "alleged cases" of rhabdo caused by Baycol were coming into his office at a rate of about one a day.

" Many of the cases are ugly," he wrote, including reports of "dialysis, long hospitalization, disability and two potentially related deaths."

Goodstein continued, "To me, it has never been an issue of, should-if-will we need to respond, but rather to whom, how, what?"

" It will be too long a time until the potentially helpful results of new epidemiologic/scientific studies envisioned by Bayer World-Wide are completed," he wrote.

In videotaped testimony played for the jury, Goodstein said he recalled being worried about the rising reports and said he had discussed with his boss and other Bayer executives whether the analysis by Niemcryk and Cislo should be disclosed to doctors.

" We decided that it was not substantive data," Goodstein said. "We can't have anybody making decisions based on unreliable data."