Internal Documents Show Concern at Bayer Over DrugMar 5, 2003 | AP Lawyers suing pharmaceutical giant Bayer over health effects from an anti-cholesterol drug called Baycol have released internal company documents during a trial in Corpus Christi.
The lawyers say the documents show Bayer was concerned about the drug long before it was pulled from the market in August 2001, after being blamed for 52 deaths, including 31 in the United States.
"There have been some deaths related to Baycol. Cas has received a call from SmithKline Beecham product management as well as SmithKline reps. Mark and Jim heard of the deaths from the field as well. So much for keeping this quiet."
June 2000 e-mail from Bayer sales and marketing official Patricia Stenger to Richard Goodstein, vice president of scientific affairs, labeled "rumors in the field."
Some of the documents dealt with increasing the dosage of Baycol to 800 micrograms, or .8 gram.
"I understand that your commercial group have estimated 50 percent of future sales will be for the 800 microgram dose. Which are expected to be about 25 million a month for this dosage strength alone at its commercial peak."
June 1999 letter from Bayer's head of worldwide regulatory affairs, Lawrence Posner, to SmithKline Beecham, a partner in marketing Baycol.
"adverse event reports received by Bayer worldwide, no samples .8 should be released, and audit of samples and inventory should be done."
Minutes from April 2001 teleconference among Bayer executives in Germany and West Haven, Conn.
"A Dear Doctor letter agreed upon in April was never mailed until 2 1/2 months later. The label with the updated safety information was never printed. A decision was apparently made to use up the currently existing inventory."
June 2001 e-mail from Mary Taylor, North American regulatory affairs for Bayer, to Posner.
Plaintiffs claim that patients who got Baycol, known by its clinical name, cerivastatin, were more likely to develop a muscle-wasting disease called rhabdomyolysis than patients using other anti-cholesterol drugs, called statins. Bayer studied the connection.
"The findings indicate that in patients receiving (one drug for cholesterol), cerivastatin substantially elevates risk for rhabdomyolysis compared with other statins."