Bayer Knew Baycol Was HarmfulFeb 23, 2003 | AP Documents released by lawyers suing German pharmaceutical maker Bayer indicate some of the company's senior executives knew its anti-cholesterol drug Baycol was causing illness and death long before Bayer pulled it off the market, a newspaper reported Saturday.
Company documents, including e-mails, memos and sworn depositions by executives, suggest that Bayer continued to promote the drug despite a company analysis that found patients on Baycol contracted a rare muscle condition much more often than patients on alternative drugs, The New York Times reported.
The condition, called rhabdomyolysis, causes muscle cells to break down, allowing their contents to flow into the blood. Even mild cases can cause severe pain and muscle weakness, and serious cases can shut down the kidneys and cause paralysis or death.
About 100 deaths and 1,600 injuries worldwide have been linked to rhabdomyolysis caused by the drug, according to the company's regulatory filings. According to Bayer, at least 6 million people worldwide took the drug before it was pulled from the market in 2001, when the U.S. Food and Drug Administration raised serious concerns.
About 7,800 lawsuits have been filed against Bayer and its British marketing partner, GlaxoSmithKline. The first trial, in Corpus Christi, Texas, began Tuesday.
Randy Hopper, an attorney for the plaintiffs, said Saturday that the documents cited by the Times were used during a hearing Feb. 7-8 in federal court in Minneapolis and copies were provided to the newspaper. U.S. District Judge Michael Davis in Minneapolis is considering whether the cases should proceed as a class action.
Bayer and GlaxoSmithKline deny wrongdoing, and Bayer contends that most patients who sued have suffered no injury. But the companies already have settled more than 400 cases for individual amounts ranging from $200,000 to $1.2 million, according to patients' lawyers.
A letter in the court filings shows senior executives at Bayer and GlaxoSmithKline knew as early as 1997 the year before Baycol sales began that higher doses of the drug might cause more problems for patients than lower doses, which had been found to be less effective than competing medicines.
Attorney Philip S. Beck, representing Bayer, said the company monitored doctors' reports on Baycol, shared those reports with regulators and repeatedly added to the written warnings on the drug's label.
Beck said Bayer believed that Baycol was safe when prescribed according to the instructions. He said the company took the drug off the market because doctors were not using it as directed.
On June 27, 1997, the day after the FDA approved Baycol, an executive at SmithKline Beecham which later merged with Glaxo wrote to a Bayer executive that he had "serious concerns" about the drug, according to excerpts of the letter included in court papers.
Jerry Karabelas, executive vice president for pharmaceuticals at SmithKline Beecham, wrote that Baycol appeared to be no stronger than a competing drug but caused "drug interactions that could be magnified at higher doses."
"Simple and safe no longer appears to be a viable promotional platform," Karabelas wrote.
Fred T. Magaziner, a lawyer representing GlaxoSmithKline, said Karabelas was writing about drug interactions that were later proved not to be a problem.