February 23, 2003
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.