He tells jurors reports were sent to FDA
03/06/2003
Reports that a cholesterol-lowering drug could produce adverse effects actually helped the company improve the drug, a Bayer executive told jurors Wednesday.
Attorneys for the pharmaceutical company cross-examined Lawrence Posner concerning the company's development of its cholesterol-lowering drug Baycol. Posner is the head of Bayer's worldwide regulatory affairs.
His testimony was part of a trial concerning an 82-year-old local man who suffered from rhabdomyolysis, a muscular disorder, after he took Baycol for less than a month.
Bayer has acknowledged that Hollis Haltom's rhabdomyolysis was a result of the Baycol that was prescribed to lower his cholesterol, and Haltom's attorneys accuse Bayer of maximizing profits at patients' expense.
Posner told jurors that if the company received a report that a patient had rhabdomyolysis in connection with Baycol, the reports were submitted on a quarterly basis to the Food and Drug Administration.
"I believe that (the reports are) valuable in learning about your own drug," Posner said. He told Bayer attorney Philip Beck that such information was useful, for example, in determining that Baycol had interaction problems with gemfibrozil, a drug used to treat heart disease.
Bayer and the FDA exchanged letters, which were submitted as evidence, showing that the drug company wanted to modify the Baycol warning labels at the same time it was trying to get government approval to market a higher dosage of the drug.
Attorneys for Haltom contend that Bayer tried to delay those warnings until the FDA approved the higher dose of Baycol.
Beck cited FDA documents that warned that the early reports were not reliable. The Adverse Drug Experience Reports that the company submitted to the FDA were not supposed to be used to determine the drug's risks, according to FDA documents.
Beck's cross-examination of Posner came after Haltom's attorneys questioned him for about two days, including some testimony on Bayer's decision to withdraw the drug from the market.
Posner's testimony is expected to continue today. The trial is expected to continue into next week.