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Merck CEO Resigns as Drug Probe Continues
Raymond V. Gilmartin led Merck & Co. for 11 years.
(By Gerald Herbert -- Associated Press)
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Erb said the FDA had not approved adding the trial results to the drug label and so they could not be discussed except by senior officials. But Erb acknowledged that the company did allow drug representatives to say that the 2000 trial had established that Vioxx helped reduce gastrointestinal bleeding. That policy led some congressmen to accuse Merck of disclosing the good news about Vioxx but hiding the bad.
Rep. Gil Gutknecht (R-Minn.) joined Democrats on the committee in sharply questioning Merck and the FDA. "It seems to me there's a disconnect here," he said. "You're saying your policies are legal, but are they ethical? Isn't this the scandal?"
A 2004 study by FDA safety officer David Graham and others estimated that Vioxx caused as many as 140,000 heart attacks and strokes and killed as many as 55,000 people. Vioxx, which was approved by the FDA in May 1999, reached $2 billion in sales in two years, faster than any drug in Merck's history.
The FDA's Steven Galson, acting director of the Center for Drug Evaluation and Research, also came under criticism for the agency's handling of the Vioxx case, especially for the substantial lag time before the worrisome cardiovascular data from the 2000 trial were added to the drug's label. Galson said the agency had learned through the Vioxx episode that it should give doctors and patients more information about drugs as the incomplete research results come in.
"The most important lesson . . . is that the American public, practitioners and patients want to get clear and accurate information as early as possible so they can participate in their own health care decisions," Galson said.
The hearing also explored previously reported efforts by Merck to "neutralize" doctors who had concerns about Vioxx's safety by paying them to take part in clinical trials and offering grants and consultancies. Merck officials said their efforts were designed to dispel misinformation about their product.
Until the Vioxx debacle, Gilmartin and Merck were highly regarded in the pharmaceutical industry. Gilmartin was a pioneer in providing cheap or free AIDS drugs to Africa, and Merck was long considered one of the most ethical -- and profitable -- companies. Since Sept. 30, the company has lost one-third of its stock value.
In a conference call yesterday, Lawrence A. Bossidy, the new chairman of the Merck board's executive committee, said of Gilmartin, "In no way did we push him out." He said the company decided it was "time for change."
Gilmartin's successor, Clark, 59, has been president of Merck's manufacturing division, which operates plants in 25 countries. Clark also served as chief executive of Medco Health Solutions Inc., one of the country's biggest managers of prescription drug programs.
