03/01/2003
A senior executive at Bayer testified in court yesterday that company
officials in the United States recommended against selling the
anticholesterol drug Baycol several years before it was introduced in 1997
because they thought its sales potential was limited.
But Baycol was introduced because officials 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, Tex., 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
lawsuits against Bayer.
Dr. Posner defended the company for several hours yesterday 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's safety officials 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 Dr. Posner, safety
officials 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
in question, 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 officials, who
were not individually identified, wrote.
Philip S. Beck, an outside lawyer for Bayer, said in an interview yesterday
that he disagreed that safety officials were ever overwhelmed. "The company
provided all the manpower that was needed," he said.
One document that lawyers for the plaintiff have mentioned at least twice is
an agenda for a meeting of Bayer's scientific relations department staff in
January 2000. It is covered with handwritten notes, some describing Bayer's
willingness to study reports of rhabdo before introducing a new higher dose
of the drug, which is an anticholesterol medicine known as a statin.
The notes on the agenda say that because Bayer had described the risk of
rhabdo in Baycol's label, "there is not a real push to find out about
statins and rhabdo."
The note -- by a person not yet identified in court -- also says that a
safety database has been developed. "Some are scared to uncover such data
(bad data) because of the launch of 0.8 mg," it says about the higher dose.
"If F.D.A. asks for bad news, we have to give, but if we don't have it, then
we can't give it to them."
Bayer did undertake an internal analysis of the reports of rhabdo cases
around that time. 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.
But the analysts also said the magnitude of the problem could not be
determined with the available data. The report said the company was talking
to health insurers and other organizations with large numbers of patients
taking Baycol about doing a better analysis.
Mr. Beck said the study was not scientific. The adverse event reports, he
said, say only that a drug may be associated with the side effect, not that
it actually caused it.
About that time, Dr. 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."
Dr. 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 Corpus Christi jury, Dr. 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
Mr. Niemcryk and Mr. Cislo should be disclosed to doctors. "We decided that
it was not substantive data," Dr. Goodstein said. "We can't have anybody
making decisions based on unreliable data."
The documents also indicate that Bayer executives decided to limit the
spread of studies with unfavorable findings on Baycol's effectiveness.
For example, at a July 1997 meeting of Bayer's Baycol publications
committee, executives discussed a study comparing cerivastatin, the chemical
name for Baycol, to simvastatin, a competing drug. "The U.S. did not want to
publish this data, since simvastatin did better than cerivastatin" and
included doses that were lower than those in another study, the minutes
said.
Bayer has been largely silent about how important the higher dose of Baycol
was to the company. But company documents indicate that Bayer was counting
on the stronger pill to increase sales.
According to minutes of a meeting of the U.S. Baycol Project team in July
2000, just before the Food and Drug Administration approved the higher dose
of the drug, executives said their goal with the higher dose was to capture
15 percent of the market. At that time, the minutes said, Baycol had 5
percent.
The minutes also say that Dr. Wolfgang Plischke, president of Bayer's North
American pharmaceutical division, attended the meeting and "reiterated the
need to drive future sales and his belief that we can achieve blockbuster
status."
Pharmaceutical companies often refer to a blockbuster drug as one that
reaches sales of $1 billion a year.
When Bayer pulled the drug from the market in August 2001, the F.D.A. said
some of the 31 deaths reported had been linked to the stronger pill.
Mr. Beck has said that Bayer knew that side effects increased with the
higher dose, but that the company began selling it to help people with
severe heart problems who needed a stronger medicine.
Another document that lawyers for the plaintiffs have raised repeatedly was
created after Baycol was pulled from the market in August 2001. The document
is a slide that was presented to top Bayer executives at a global planning
meeting in December 2001 that says, "DIG; THROW (The Corpse); COVER (With
sand)."
Lawyers for the plaintiffs say the document is one of many supporting their
allegation that Bayer covered up information about the serious risks of
Baycol.
But Mr. Beck told the jury that the document -- one slide in a set presented
to top global Bayer executives -- should be disregarded. It refers, he said,
to a plan by people at the company who wanted Baycol put back on the market.
The author of the slide wished to make the point that putting Baycol back on
the market was a bad idea that should be buried, Mr. Beck told the jury.