http://www.cnn.com/2004/HEALTH/11/26/fda.baycol.ap/index.html

FDA reviewing records on Baycol
Official says review could lead to criminal investigation

WASHINGTON (AP) -- 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 its
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.
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