ot: FDA Reviews When Bayer Revealed Drug Risks - could lead to a criminal investigation - Baycol

November 27, 2004

[Despite such headlines, thimerosal, the IOM, the CDC folks who

engineered deliberate data-dilution continue to have a " get out of jail

free " card. -]

FDA Reviews When Bayer Revealed Drug Risks

By DIEDTRA HENDERSON

AP Science Writer

November 27, 2004, 5:06 AM EST

http://www.newsday.com/news/health/ats-ap_health10nov27,0,6382391.story

WA$$$HINGTON -- In a move that could lead to a criminal investigation,

the government is checking its records to determine if drug maker Bayer

AG was forthcoming about safety concerns with its cholesterol-lowering

Baycol drug that surfaced within months of it hitting the market.

If this week's allegations prove true that the company knew but was slow

to inform the government that its drug was riskier than comparable

drugs, the Food and Drug Administration could begin a criminal

investigation, one official said this week.

Bayer internal company records now in the public domain indicated that

by May 28, 1998, three months after the drug went on the market, people

who took the drug with gemfibrozil, another cholesterol-lowering drug,

had elevated levels of an enzyme that accompanies muscle injury or had

developed a rare muscle-wasting disorder. Bayer did not warn doctors and

patients not to take the two drugs together until December 1999, four

scientists wrote in a Journal of the American Medical Association paper

released this week.

In addition Bayer scientists knew in late 1999 and early 2000 that using

Baycol alone " substantially increased the risk " of people getting a rare

muscle-wasting condition, compared with a rival drug, but they did not

immediately alert physicians or patients. FDA rules require speedy

notification of serious side effects linked to drugs.

The JAMA article alleged that " before the agency was aware of the data,

the company knew that the drug was more dangerous than others. If this

allegation is correct, the FDA takes it extremely seriously and we're

going to have our criminal investigators look into this, " Dr.

Galson said during a C-SPAN appearance. Galson is acting director of the

FDA's Center for Drug Evaluation and Research.

" Right now, we don't really know whether that's true or not, " said

Galson. " We read about it in this level of detail for the first time " in

the JAMA papers, he said.

FDA spokeswoman Kathleen Quinn said, " Bottom line: We have to go back

and look at all the data (to) see what we have and compare and make sure

we had all we could have -- which we think we did. "

Bayer said in a statement that the JAMA articles " contain no new

information regarding Baycol and Bayer's timely reporting of data. Bayer

kept the FDA fully informed about all pertinent safety information,

including adverse event reports. Indeed, an FDA audit of Bayer's

postmarketing practices during the time Baycol was on the market

demonstrated no deficiencies. "

Its pharmaceutical division withdrew Baycol from the market on Aug. 8,

2001, after it was linked to a sometimes fatal muscle-wasting condition,

rhabdomyolysis. By then, the FDA had received reports that 31 Americans

died from severe rhabdomyolysis after using Baycol. Twelve of those

people used Baycol in combination with gemfibrozil.

The company reported it paid $1.1 billion, without admitting liability,

in out-of-court settlements of 2,895 cases related to Baycol side

effects. The suits were filed after Baycol was withdrawn from the

market. Some 7,169 cases are still pending.

Besides published scientific reports and FDA data, the authors of the

JAMA paper reviewed internal Bayer documents that entered the public

record due to lawsuits filed against the company.

In long-term clinical trials, cholesterol-busting statins atorvastatin,

lovastatin, pravastatin and simvastatin were associated with lower risks

of causing patients to develop the muscle-wasting condition, the JAMA

paper said. Baycol represented only 2 percent of market share -- 9.8

million of 484 million statin prescriptions written. Yet Baycol was

linked to 57 percent of the muscle-wasting side effects reported by

statin users between January 1990 and March 2002.

In an accompanying paper in JAMA, however, an attorney defended the

company's actions and noted that at least two of the authors of the JAMA

article had been paid experts in plaintiffs' lawsuits against Bayer.

" It always is possible to second guess decision-making after the fact, "

wrote ph D. Piorkowski Jr., outside counsel in Baycol litigation for

Bayer Corp., the German drug maker's U.S. subsidiary. " However, when

judged fairly by all the facts in their proper context, Bayer's conduct

in the marketing of (Baycol) from 1997 to its voluntary withdrawal from

the market in August 2001 was responsible, appropriate, and consistently

motivated by concern about the safety and welfare of patients. "

* __

On the Net:

Bayer: http://www.bayer.com/

FDA's Baycol Page: http://www.fda.gov/cder/drug/infopage/baycol/default.htm

November 28, 2004

So why don't the thimerosal people get this out into the associated

press??????

Barb

[ ] ot: FDA Reviews When Bayer Revealed Drug Risks -

could lead to a criminal investigation - Baycol