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Sunday, February 23, 2003But on June 27, 1997, the day after Baycol was approved by the Food and Drug Administration, Jerry Karabelas, executive vice president for pharmaceuticals at SmithKline Beecham, which later merged with Glaxo, wrote to David Ebsworth, president of Bayer's North American pharmaceutical operations, saying he had "serious concerns" about using the drug with some other medicines, according to excerpts of the letter included in court papers. Mr. Karabelas said that Baycol appeared to be no stronger than a competing drug called Lescol. But, he said, Baycol also caused "drug interactions that could be magnified at higher doses." "Simple and safe," Mr. Karabelas wrote, "no longer appears to be a viable promotional platform." ...In December 1999, Bayer added a warning to the drug's label saying that Baycol should not be prescribed with Lopid — a warning stronger than those on the labels of similar drugs. A drug's label, which is approved by the F.D.A., is a document included in a drug's package that often spans many pages, and doctors rely on these labels when they prescribe medicines. ...In May 2000, when Bayer was anticipating F.D.A. approval of the stronger version of Baycol in July, Dr. Richard Goodstein, vice president for scientific relations at Bayer, sent an e-mail message to Patricia Stenger, a manager in Bayer's scientific affairs division, about a meeting of the "Baycol Project team." Dr. Goodstein told Ms. Stenger that he saw "a false comfort factor in place across the company" about the drug ..That November, Bayer analyzed reports of side effects and found that patients taking Baycol alone had 5 to 10 times the chance of developing rhabdo as patients on the other medicines. Mr. Beck said Bayer then hired Pacificare, a managed care company, to more thoroughly analyze Baycol's risks among its members. The study did not include patients taking the highest dose of Baycol. It found that the drug at lower doses was no more risky than other statins as long as it was prescribed according to the label directions, Mr. Beck said. ...In December 2000, the Harris County public hospital system in Houston stopped using Baycol after seeing six cases of rhabdo in just nine months in patients taking the drug. The increase in rhabdo cases "was a noticeable thing in a hospital system our size," said Dr. David Hyman, chief of general internal medicine at Ben Taub General Hospital in Houston. "We made a decision we were uncomfortable with the drug." Eight months later, in August 2001, Bayer pulled Baycol from the market. None of that looks too good for the company. But the following doesn't make the lawyers look good, either: But approximately 100 deaths and 1,600 injuries worldwide have been linked to a muscle disorder caused by the drug, according to regulatory filings by the company. ....More than 10,000 patients who took Baycol or the families of those who died have filed lawsuits against Bayer and GlaxoSmithKline. The first trial, in Corpus Christi, Tex., began Tuesday. They know a cash cow when they see one. Bayer's being sued by about six times the number of people who were actually injured by the product. Maybe the company was negligent in not pulling it from the market sooner, but that’s no reason they should pay damages to people who weren’t harmed by it. posted by Sydney on 2/23/2003 02:58:00 PM 0 comments 0 Comments: |
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