"Skeptic" <[email hidden]> wrote in message news:<WkTlc.22054$Ia6.3198278@attbi_s03>...
Quoted message said:The source is an online Canadian news source. The sources
the article quotes as proof of this are zero. Ilena...
posting more hearsay, are we? According to Star magazine -
with just as many sources as your article - George
Washington was really a woman and Mars (or Saturn?... I
forget now) is really an alien space station.
Of course, without a means of verifying stories, they are
just that stories - works of fiction. Have a good day (and
do try to spend this one in reality).
And read this:
February 22, 2003 Papers Indicate Bayer Knew of Dangers of
Cholesterol Drug By MELODY PETERSEN and ALEX BERENSON
ewly disclosed company documents indicate that some senior
executives at Bayer were aware that their anticholesterol
drug had serious problems long before the company pulled it
from the market.
The documents, made public by lawyers suing Bayer, include
e-mail messages, memos and sworn depositions of executives
that suggest that Bayer promoted the drug, Baycol, even as a
company analysis found that patients on Baycol were falling
ill or dying from a rare muscle condition much more often
than patients on similar drugs.
The lawyers are suing Bayer, which is based in Germany, and
its British marketing partner, GlaxoSmithKline, in federal
court in Minneapolis and in dozens of other cases around the
country. Though the documents do not paint a full picture of
what the companies knew, or how early they knew it before
Baycol was pulled from the market in 2001, they provide a
rare glimpse inside a major drug company's marketing efforts
in the face of mounting indications of trouble.
Bayer, which developed Baycol, says the drug was marketed
appropriately and is safe when used properly.
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. Similar
drugs are at least as effective as Baycol but cause the
disorder much less frequently, according to the Food and
Drug Administration.
The F.D.A., which allowed the sale of two higher doses of
Baycol in the years after initially approving the drug, said
it did not see a rapid increase in deaths until the spring
of 2001, and Bayer took the drug off the market shortly
after the agency raised serious concerns about it with
company executives in late July.
The drug, which studies found to be less effective at its
initially approved strength than competing medicines, caused
more problems at higher doses. Senior executives at Bayer
and GlaxoSmithKline were aware that this might be possible
as early as 1997, according to a letter that is part of the
court filings.
Philip S. Beck, a lawyer with Bartlit Beck Herman Palenchar
& Scott, who is representing Bayer, said the company
monitored reports on Baycol from doctors, shared those
reports with regulators and repeatedly added to the written
warnings on the drug's label. "We did what companies should
do," he said.
Patricia Seif, a spokeswoman for GlaxoSmithKline, said the
company's "promotion of Baycol was fully consistent with the
product label that the F.D.A. approved."
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.
Bayer and GlaxoSmithKline have settled more than 400 of the
cases for individual amounts ranging from $200,000 to $1.2
million, according to lawyers for the patients. At that
rate, the drug makers could pay billions of dollars to
resolve all the lawsuits. The companies deny the allegations
in the lawsuits, and Bayer says that no more than 15 percent
of the patients who have sued actually suffered any injury
and that it is trying to settle most of those claims.
Lawyers for the plaintiffs dispute that estimate.
The companies have agreed that Bayer, which discovered the
drug and played the biggest role in marketing it, will pay
95 percent of the cost of settling cases.
Mr. Beck said that the company still believed that Baycol
was safe when prescribed according to the instructions
and warnings in its label. Bayer took the drug off the
market, he said, because doctors were not using it as
directed by the label.
The company was also being pressured by the F.D.A. The
agency had allowed Bayer to sell higher doses of Baycol
because it did not notice unusual rates of complications
from the drug. But Dr. David G. Orloff, director of the
F.D.A. division that reviewed Baycol, said that in the
spring of 2001, less than a year after approving a higher
dosage of Baycol, the agency noticed a sharp jump in reports
of deaths and serious injuries in patients using Baycol, and
after investigating the reports it pressed Bayer to pull the
drug. "It took time and tragedy to understand it was
different," he said.
The drug makers have demanded that many documents in the
cases remain sealed, and judges have acceded to the request.
The documents that have become public have been introduced
in court by lawyers for plaintiffs trying to broaden the
lawsuit against Bayer and seek additional damages. The
available documents show how the companies responded as they
received reports of a dangerous side effect called
rhabdomyolysis, which causes muscle cells to break down and
their contents to flow into the blood.
Even mild cases of rhabdo, as doctors commonly call the
condition, can cause severe pain and muscle weakness. In
more serious cases, rhabdo can cause paralysis or death as
the kidneys shut down.
John Nahay, 71, said he "just got weaker and weaker" after
beginning to take Baycol in the summer of 2001, shortly
before it was pulled from the market. Mr. Nahay, who lives
in Langhorne, Pa., and is among the thousands who have sued
Bayer, must now undergo dialysis treatments three times a
week and is largely confined to his house. "It's hard to
believe that that little pill could do that," he said.
Regulators approved Baycol in June 1997, making it the sixth
of a group of popular cholesterol reducers called statins.
By August 2001, when Baycol was removed from the market, at
least six million people worldwide had taken the drug,
including 700,000 Americans, according to Bayer. With sales
that year expected to exceed $600 million, it had become one
of the company's fastest-growing products.
But 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.
Ms. 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."
Fred T. Magaziner, a lawyer with the Dechert law firm that
is representing GlaxoSmithKline, said that Mr. Karabelas was
writing about drug interactions that were later proved not
to be a problem with Baycol.
Still, the e-mail message indicates that some top executives
had concerns about the drug's safety early on.
Bayer began marketing Baycol in early 1998, and doctors soon
began reporting serious side effects. In April 1999, Dr.
William Pogson, a cardiologist in Independence, Mo., wrote
in The American Journal of Cardiology that a patient had
developed "profound muscle weakness, and the inability to
walk" in September 1998 after taking Baycol for three weeks
alongside Lopid, another type of cholesterol drug. A few
months later, a second patient of his developed rhabdo while
taking Baycol, but not Lopid. "It made me want to stay away
from the drug," Dr. Pogson said in an interview.
Nonetheless, the F.D.A. approved a stronger dosage of 0.4
milligram of Baycol in May 1999.
That October the F.D.A. expressed its first public concerns
about Bayer's marketing, warning the company in a letter
that its sales materials were "false, lacking in fair
balance or otherwise misleading" and that they underplayed
"the most important risk information" on rhabdomyolysis.
Mt. Beck said the warning was isolated and similar to dozens
of others received by drug companies, including the
makers of other anticholesterol drugs.
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.
Some Bayer executives, however, were aware that doctors
might ignore the label change. In August 2000, Laurie
Simpson, a manager in Bayer's strategic analysis division,
wrote to Tig Conger, vice president for cardiovascular and
metabolic marketing, saying, "If the physician's experience
is that he/she has safely used combinations in the past,
tendency would be to discount the contraindication."
Mu. Beck, Bayer's lawyer, said the warning about drug
combinations was emphasized in all sales material.
As the drug became more widely used, more doctors reported
problems. In April 2000, three Spanish doctors reported in
The Annals of Internal Medicine a case of rhabdo in a woman
who had taken Baycol but not Lopid.
At the same time, Bayer was preparing to introduce
another new, higher dosage of Baycol. At least one health
official of the company expressed concerns about the new
stronger version.
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.
Reached at her home, Ms. Stenger said she could not comment.
Dr. Goodstein did not return telephone calls, but Mr. Beck
said Dr. Goodstein was concerned about Bayer's reputation in
the medical community and not about Baycol's safety.
"With the stronger medicine there is always a chance of more
adverse reactions," Mr. Beck said, "but some people need the
stronger medicine." He said that Bayer warned doctors of the
risks of the higher dose but believed that it could be
safely prescribed.
The new tablet was approved by the Food and Drug
Administration in July 2000. The label on the new 0.8
milligram tablets stated that doctors should start patients
on a lower dose.
At the same time, reports of problems were increasing.
In an August 2000 article in the journal Angiology,
Turkish doctors reported a death after a patient took
Baycol and Lopid.
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.
Mv. 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.
Still, the reports of problems with Baycol continued. 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.
Copyright 2003 The New York Times Company | Privacy Policy
