Merck CEO Resigns as Drug Probe Continues
Friday, May 6, 2005
Merck & Co.'s longtime leader Raymond V. Gilmartin abruptly resigned yesterday on the same day congressional investigators released a slew of documents detailing how the company continued to aggressively promote its arthritis drug Vioxx after it knew of potentially serious safety concerns.
The documents made public by the House Committee on Government Reform showed that Merck directed its 3,000-person Vioxx sales force to avoid discussions with doctors about the cardiovascular risks identified in a major clinical trial of the drug in 2000. Sales representatives were told instead to rely on a "Cardiovascular Card" that said Vioxx was protecting the heart rather than potentially harming it.
Vioxx was withdrawn from the market last September after another clinical trial found that people who had taken the drug for 18 months were five times more likely to have heart attacks and strokes than those on a placebo. The withdrawal tarnished Merck's reputation and cost the firm billions in sales, stock value and legal fees.
The company, which had earlier said Gilmartin, 64, would stay in place until his scheduled retirement next year, said his sudden departure as chairman, president and chief executive officer had nothing to do with the Vioxx controversy. Merck named its president for manufacturing, Richard T. Clark, to replace Gilmartin as chief executive officer and president.
The resignation of Gilmartin, after he spent 11 years at the helm, came on a day when Merck was sharply criticized in a hearing into how the company and the Food and Drug Administration had handled the safety concerns surrounding Vioxx.
Merck and other drug companies say their "detailers" act as neutral educators to guide physicians in prescribing drugs, but the more than 20,000 pages of documents released yesterday showed that Merck's representatives were coached to be aggressive salesmen.
They were trained how to smile, speak and position themselves most effectively when talking with doctors, and were exhorted to sell Vioxx and other Merck drugs using the Rev. Martin Luther King Jr.'s "I Have a Dream" speech.
Rep. Elijah E. Cummings (D-Md.) read from a Merck training manual that directed instructors to play a recording of the speech and then say to the sales force: "King was someone with goal-focus -- he kept getting shut down but kept going. . . . Just as with a physician, you must keep repeating the compelling message and at some point, the physician will be 'free at last' when he or she prescribes the Merck drug, if that is most appropriate for the patient."
"Merck says the mission of its sales force is to educate doctors," said Rep. Henry A. Waxman (Calif.), the panel's ranking Democrat. "This sales force is given extraordinary training so that it can capitalize on virtually every interaction with doctors. Yet when it comes to the one thing doctors most need to know about Vioxx -- its health risks -- Merck's answer seems to be disinformation and censorship."
Dennis Erb, Merck's vice president for global regulatory development, said that company's actions were timely and appropriate, and that detailers were trained to be "accurate and balanced" in presenting information. He said Merck has conducted 70 clinical trials on Vioxx involving more than 40,000 patients, and the company is discussing with the FDA whether to apply for approval to resume marketing the drug.
"We believe Merck acted appropriately and responsibly to extensively study Vioxx after it was approved for marketing to gain more clinical information about the medicine," he said. "And we promptly disclosed the results of these studies to the FDA, physicians, the scientific community and the media."
Erb defended Merck's policy of instructing its representatives not to tell doctors about the troubling cardiovascular results from a large 2000 clinical trial called Vigor. Until it withdrew Vioxx, Merck had argued that naproxen -- the control drug in the 2000 trial -- lowered cardiovascular risks, not that Vioxx raised them.