By Marc Kaufman
Washington Post Staff Writer
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Vioxx was withdrawn from the market last September after another clinical trial found that people who had taken the drug for 18 months were five times more likely to have heart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.
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.