09 November 2004

Regulators scrutinize drug firms' practices
Merck faces criminal probe

Merck and Pfizer face increased scrutiny as federal and state governments probe more deeply into the drug giants' business practices.

Merck said Monday that it is the subject of a criminal investigation by the Justice Department regarding the "research, marketing and selling" of its recalled pain reliever, Vioxx. Merck also disclosed, in the same regulatory filing, that the Securities and Exchange Commission has launched an informal inquiry.

Merck pulled Vioxx off the market Sept. 30 after a study found it increased the risk of heart attack and stroke in some patients. The company says 375 lawsuits have been filed alleging injuries from use of the blockbuster drug.

No. 1 drugmaker Pfizer, meanwhile, is fielding inquiries from New York Attorney General Eliot Spitzer, who is examining "off-label" drug use. The company said it received a letter from Spitzer requesting documents and information about clinical trials of some Pfizer drugs for ailments other than those approved by the Food and Drug Administration.

Connecticut Attorney General Richard Blumenthal has requested similar materials concerning antidepressant Zoloft, including its promotion for treating young people with depression. He says the request is part of a broader probe into off-label prescribing.

Last month, the FDA ordered drugmakers to put "black box" warnings on antidepressants, saying the drugs have been linked to increased risks of suicidal behavior among children and teenagers.

Doctors can prescribe drugs for any ailment they want. But drugmakers cannot promote drugs for conditions the FDA has not approved.

Earlier this year, Pfizer's Warner-Lambert division pleaded guilty to illegally marketing a drug called Neurontin to treat ailments for which it was not FDA-approved. Pfizer, which did not own Warner-Lambert when the government said the wrongdoing occurred, paid $430 million to settle the case.

Pfizer also said it will probably put a black-box warning about a rare but serious skin reaction on the label of Bextra, an arthritis drug in the same class as Vioxx and Pfizer's Celebrex. The skin reaction is most likely to occur within the first two weeks of therapy, Pfizer said. It added a warning about the potentially fatal skin reaction, known as Stevens-Johnson syndrome, in 2002.

Pfizer reiterated that research has not found Bextra raises the risk of heart attack or stroke in arthritis patients, although the longest study lasted only a year.

Merck shares dropped 1.7% in after-hours trading -- after news of the Justice probe came out -- to $26.13. Pfizer shares fell 1.3% Monday to $28.41.

By Julie Schmit
USA TODAY

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