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Documents Suggest Bayer Knew Baycol Problems

Feb 23, 2003 | CNN Newly released documents suggest some executives at Bayer were aware there were problems with its anti-cholesterol drug Baycol well before the company pulled the drug from the market.

The papers, given to CNN by an attorney in a personal injury suit against the company, include e-mails and depositions that appear to indicate Bayer was promoting the drug at the same time there were internal discussions about deaths related to Baycol. The documents were first reported in The New York Times Saturday.

One executive wrote in a February 2000 e-mail that word was leaking about deaths related to the drug.

"I am concerned that there is widespread knowledge in the field with both Bayer and SB [marketing partner SmithKline Beecham, which has since become GlaxoSmithKline] representative[s] that there have been some deaths related to Baycol," the executive wrote.

The e-mail suggested Bayer make an official statement before rumors make things worse. "So much for keeping this quiet," it said.

The executive to whom the e-mail was addressed denied in a sworn deposition any attempt to conceal information.

Dr. Richard Goodstein, vice president for scientific affairs at Bayer, was asked in a deposition, "Did you folks at Bayer ever intentionally delay publication of a medical article with the sole purpose of increasing Bayer's profits because the article might give doctors information that was critical of your product?"

Goodstein responded: "I'm personally not aware of that, nor would I ever think that would be the policy of the company."

Bayer's legal counsel, Philip Beck, told the Times the company monitored reports on Baycol, shared the information with regulators, and changed warnings on the drug's label.

"We had a problem getting doctors to use it as directed on the labels, and the majority of cases came from the minority of cases where doctors were not using it as directed on the label," Beck told CNN.

"We concluded that we could not get doctors to use it as directed, and that was the principle for removing it from the market."

Beck emphasized that in only a tiny fraction of cases did users suffer long-term or fatal side effects from taking Baycol.

A spokesman for GlaxoSmithKline told CNN that in marketing Baycol it made no claims inconsistent with product labeling.

Bayer and GlaxoSmithKline are currently facing lawsuits from thousands of people who took Baycol or have relatives who died after taking the drug.

A personal injury case against Bayer just went to trial in Corpus Christi, Texas. The plaintiff in that suit, Hollis Heltom, 82, is suing the company for $100 million.

Holtom's suit claims Bayer acted negligently and with malice. He says he suffered various problems within two weeks after switching from a competing drug to Baycol.

Beck said the documents released by the plaintiff's attorneys are selective. "We are confident that our story is coming in and the jury is understanding it," he said.

"We believe that Bayer acted responsibly and appropriately in how it developed and marketed Baycol," Beck said. "We also believe that Bayer is acting responsibly in its efforts to resolve cases in which patients experience side effects from Baycol."

Baycol is a member of a class of drugs known as statins, which reduce cholesterol by blocking an enzyme called HMG-CoA reductase, which is involved in the formation of cholesterol.

Bayer removed Baycol from the market in July 2001 after the FDA cited concerns about a potentially fatal condition known as rhabdomyolysis the breaking down of muscle that can be associated with all statins.

Holtom's suit says he suffered from the condition.

Although it is a rare side effect, rhabdomyolysis can lead to kidney failure and death. The FDA found that the link between it and Baycol was much stronger than with other statins.

Symptoms of rhabdomyolysis include muscle pain and weakness, fever, dark urine, nausea and vomiting. The muscles most frequently involved include the calves and lower back, though some patients reported no symptoms, the FDA said.

Baycol was considered extremely important to Bayer, internal documents show. Bayer was hoping it would compete with Pfizer's successful anti-cholesterol drug Lipitor.

While deaths have also been associated with Lipitor, the rate is low considering that millions more people use Lipitor than use each of the other statins, including Baycol.

"We need to do everything possible to maximize sales results since Baycol must carry the company for the short and long haul," a sales executive wrote in an e-mail dated May 1998.

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