Bayer executive's testimony
cites early doubts on Baycol
(New York Times / March 3, 2003) -- A senior executive at Bayer AG
has testified in court that other company executives in the United States
recommended against selling the anti-cholesterol drug Baycol several
years before it was introduced in 1997 because they thought its sales
potential was limited.
But Baycol was introduced because executives in Germany, where Bayer
is based, decided to push ahead when market conditions improved and the
potential for profit looked promising for many years.
Sales of Baycol increased rapidly until Bayer pulled Baycol off the
market in 2001 after more than 30 deaths were linked to the drug. The
company has been dealing with the aftermath since.
The Bayer executive, Dr. Lawrence Posner, senior vice president for
pharmaceutical development, was testifying in county court in Corpus
Christi, Texas, on Friday in a case brought by a patient who contracted
a muscle disorder called rhabdomyolysis after taking Baycol.
It is the first case involving Baycol to go to trial. More than 10,000
patients or the families of those who died after taking Baycol have filed
suits against Bayer.
Posner defended the company for several hours as lawyers for the plaintiff,
Hollis Haltom, 82, introduced dozens of internal company documents into
evidence.
He said Bayer had monitored reports of rhabdomyolysis, known as rhabdo,
in patients taking Baycol and had properly informed doctors about the
risks of the medicine as it learned of them.
But several memos from Bayer safety officers in 1999, made public earlier
in the trial, describe how its staff was struggling to respond to an
increasing number of reports of patients who had become ill with rhabdo
while taking Baycol.
In a memo written on Dec. 30, 1999, and addressed to Posner, safety
executives said they had received reports of 60 cases of rhabdo in the
United States in the previous two months. Doctors and others observing
people becoming ill or dying while taking a medicine voluntarily file
the reports, known as adverse event reports, with regulators and the
drug's manufacturer.
" The steadily increasing numbers of spontaneous reports of rhabdomyolysis
associated with Baycol, along with the additional telephone activity,
has overwhelmed the available safety assurance resources," the executives,
who were not individually identified, wrote.
Bayer did undertake an internal analysis of the reports of rhabdo cases.
In March 2000, Steve Niemcryk, an epidemiologist at Bayer, and Paul Cislo,
a database analyst, reviewed the reports of rhabdo that regulators received
through June 1999.
They said Baycol "substantially elevates" the risk of rhabdo,
compared with similar drugs on the market.
About that time, Richard Goodstein, vice president for scientific relations
at Bayer, wrote an e-mail message to two dozen Bayer executives working
on Baycol in the United States. He said that "alleged cases" of
rhabdo caused by Baycol were coming into his office at a rate of about
one a day.
" Many of the cases are ugly," he wrote, including reports
of "dialysis, long hospitalization, disability and two potentially
related deaths."
Goodstein continued, "To me, it has never been an issue of, should-if-will
we need to respond, but rather to whom, how, what?"
" It will be too long a time until the potentially helpful results
of new epidemiologic/scientific studies envisioned by Bayer World-Wide
are completed," he wrote.
In videotaped testimony played for the jury, Goodstein said he recalled
being worried about the rising reports and said he had discussed with
his boss and other Bayer executives whether the analysis by Niemcryk
and Cislo should be disclosed to doctors.
" We decided that it was not substantive data," Goodstein
said. "We can't have anybody making decisions based on unreliable
data." |
