Report: Merck misled Doctors

posted on:
May 6, 2005

author:
Staff

 A congressional committee accused Merck & Co. yesterday of withholding information from doctors and misleading them about the health risks of the company’s blockbuster drug Vioxx after research began linking the pain reliever to increased heart attack risks five years ago. 

During a hearing, the House Committee on Government Reform documented how the Whitehouse Station drug giant used a blitz by a legion of sales representatives to boost sales even while evidence of the painkiller’s dangers was mounting.

The committee provided an inside look at how Merck trained its 3,000-person sales force to persuade doctors to prescribe Vioxx and other Merck products. No interaction with a physician was too insignificant to be addressed, the panel said, from how long to shake hands (three seconds) to how to use “verbal and nonverbal” cues to gain trust.

Merck instructed sales representatives on different personality types of doctors and recommended techniques for each type. The company also provided motivational courses, which compared the “defining moments” of selling Merck drugs to critical points in the lives of Helen Keller, Martin Luther King, George Washington and Tiger Woods.

The disclosures came as embattled Merck chief executive Raymond Gilmartin stepped down, effective immediately, and was succeeded by longtime Merck executive Richard Clark.

The past months have seen a string of revelations regarding Merck’s handling of Vioxx, which the company pulled off the market last September, but never had Merck’s sales practices been laid as bare as they were yesterday.

“When concerns about Vioxx’s safety arose, Merck appeared to use this highly trained force to present a misleading picture to physicians about the drug’s cardiovascular risks,” said the report prepared by the panel’s Democratic staff and based on a review of 20,000 pages of internal Merck documents.

Dennis Erb, a Merck vice president, said the company acted “appropriately and responsibly.”

He told the House panel Merck widely disseminated research findings as they developed concerning the heart risks, while its sales force, in discussions with doctors, stuck to information that was part of the drug’s labeling.

If doctors had questions about research that was not part of the original 1999 drug approval and labeling process, he said, sales representatives told them to make inquires at the company’s headquarters. Erb said Merck received 123,000 requests for information.

But the committee report said the documents show Merck instructed its sale force not to address negative research findings in dealings with doctors, but to “emphasize outdated and misleading data that indicated Vioxx was safer than alternatives.”

Rep. Henry Waxman (D-Calif.), the ranking Democrat on the committee, said Merck claims the mission of its sales force is to educate doctors. But its own documents undercut that, he said.

“When it comes to the one thing doctors most needed to know about Vioxx—its health risks—Merck’s answer seems to be disinformation and censorship,” Waxman said.

Rep. Tom Davis (R-Va.), the chairman of the committee, said the inquiry raises serious questions about Merck’s conduct and candor regarding Vioxx, a drug that was taken by 80 million patients and generated $2.5 billion a year in sales before it was removed from the market.

Steven Galson, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, testified Merck’s sales force had a legal obligation only to provide information that was in the approved drug labeling. But Galson said it is also “important the company convey truthful information that is up to date.”

He said Merck appears not to have provided “the entire picture.”

To overcome the “cardiovascular obstacles” to increased sales, the committee report said the company launched special marketing programs called “Project XXceleration” and “Project Offense.”

The committee staff report said that after each negative development regarding Vioxx, Merck sent bulletins or special messages to its salespersons “directing them to use highly questionable information to assuage any physician concerns.”

The committee said the documents show:

After a company study in March 2000, known as VIGOR, reported increased heart attack risks, Merck directed its sales force to show physicians a “cardiovascular card” that made it appear Vioxx could be eight to 11 times safer than other anti-inflammatory drugs. The card omitted any reference to VIGOR and was based on data the FDA considered to be inappropriate for a safety analysis.

After an FDA advisory committee agreed in a 2001 vote that physicians should be informed of the risks found in the VIGOR study, Merck sent a bulletin to its sales force that advised: “Do not initiate discussions of the FDA Arthritis Committee … or the results of the … VIGOR study.” If physicians asked about the study, Merck representatives were told to respond, “I cannot discuss the study with you.”

After the New York Times reported on the cardiovascular danger of Vioxx in May 2001, Merck instructed its field staff to tell physicians that patients on other anti- inflammatory medications were eight times more likely to die from cardiovascular causes than patients on Vioxx.

After extensive negotiations with the FDA, Merck agreed to a label change for Vioxx in April 2002 that mentioned the cardiovascular risks found in the VIGOR study, but it included a statement that the significance of the findings was “unknown.” The committee said Merck then instructed its sales force to emphasize the uncertainty of the VIGOR study to counter physician’s concerns.

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