Yet another drug company caught with its pants down

[Guest guest]

Bayer's Big Mistake

Herper, 09.29.06, 6:10 PM ET

German drug giant Bayer failed to tell the U.S. Food and Drug Administration

of a study that connected a controversial heart surgery drug to dangerous

side effects and death, even as FDA convened a panel of experts to evaluate

the drug's safety.

The company notified the FDA after it was asked to do so by the scientist

conducting the study.

Bayer said in a statement that it " mistakenly " did not tell the FDA about

the evaluation of 67,000 hospital records regarding the drug Trasylol, which

is used to prevent bleeding during open-heart surgery. According to a Public

Health Advisory from the FDA, the new study linked Trasylol to increased

risk of death, serious kidney damage, congestive heart failure and strokes.

" Why this wasn't made available at the panel meeting a week ago, I have no

idea, " says Hiatt, the University of Colorado vascular medicine

specialist who chaired the panel. " It seems irregular. "

Bayer's flub could become grist for a public debate that could further fuel

a growing movement to improve drug safety in the United States by enhancing

the FDA's powers.

Last week, a report from the influential Institute of Medicine argued that

the FDA should have significantly more powers to prevent disasters like the

recall of the arthritis pill Vioxx by Merck two years ago. Two different

bipartisan teams in the Senate are pushing for different overhauls of the

drug safety system.

As of December 2005, the drug accounted for sales of $300 million, at a cost

of $1,400 per dose, making it a relatively small seller by drug industry

standards. It is impossible to say from current data how many patients might

have been adversely affected.

On Jan. 26, a paper in the New England Journal of Medicine from researchers

at the Ischemia Research and Education Foundation in San Bruno, Calif., made

a case that Trasylol increased the risk of kidney problems, heart attacks

and strokes. On Sept. 21, the FDA's panel of medical experts met to consider

that data and voted 18 to 0 that Trasylol did not need new safety labeling.

The FDA was not informed of the new study until Wednesday, Sept. 27.

A Bayer spokeswoman says that Bayer contracted Ingenix, a company that

specializes in data-mining hospital databases, to conduct the analysis in

the first half of 2006. It notified the FDA after it was asked to do so by

, the researcher at Ingenix who was conducting the analysis.

Hiatt said that the database from the New England Journal study was also not

made available to the FDA, making it difficult for the panel to consider

them. Trasylol already carries a " black box " on its labeling, which warns

doctors that it can cause kidney problems.

In a prepared statement, Bayer said that it remains committed to patient

safety and to evaluating the safety and efficacy of Trasylol. The company

also pledged to further investigate the matter and take corrective action.

Regards,

Do not follow where the path may lead;

go instead where there is no path and

leave a trail.