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Company deceived doctors about Vioxx's safety, lawmaker says

WASHINGTON—After a March 2000 study linked Merck's painkiller Vioxx to heart problems, Merck instructed its marketing force not to discuss the findings with physicians, according to company documents released Thursday by a congressional committee. Instead, Merck's sales staff provided doctors with different studies that suggested Vioxx was safe.

Those actions, along with a multimillion-dollar ad campaign, helped make Vioxx a success for Merck. It reached $2 billion in annual sales faster than any of the company's other drugs, said Rep. Henry Waxman, D-Calif. But Vioxx may also have been a factor in thousands of heart attacks and strokes in patients who would have been better served with another medication, according to medical experts.

A senior Merck marketing official rejected charges that Merck had misled doctors and said the information provided to them was true and balanced.

Waxman, the ranking minority member of the House Government Reform Committee, charged that the 20,000 pages of documents that Merck submitted to the committee show that Merck's sales force was permitted to discuss only approved journal articles that "provide solid evidence as to why doctors should prescribe Merck products."

The committee is investigating actions by Merck and the Food and Drug Administration prior to Merck's decision to withdraw Vioxx from pharmacy shelves in September 2004.

Merck faces more than 2,300 personal injury lawsuits and more than 200 class-action lawsuits related to Vioxx. Its profits and market value have slumped sharply since the drug's withdrawal, and on Thursday, Merck CEO Raymond Gilmartin stepped down. Richard Clark, a senior Merck executive, replaced him.

The House committee released hundreds of pages of company documents detailing how Merck's 3,000-member sales force persuaded doctors and hospitals to prescribe their products, including the once-popular arthritis painkiller Vioxx.

The documents also reveal much about how drug sales personnel work with doctors.

The instructions told marketers how to be good listeners: "nod head," "don't interrupt," "take notes," "sound interested" and "use voice inflection and energy." They also described how the proper handshake should be "firm, but painless," last "about three seconds," come "with eye contact" and "start and stop crisply."

At Thursday's hearing on Capitol Hill, Waxman told committee members that after a study linked Vioxx to heart problems in 2000, Merck's sales force provided doctors with "inaccurate and misleading" information that claimed Vioxx was "eight to 11 times safer" than other anti-inflammatory painkillers.

The information that sales personnel handed out to doctors didn't include findings of Merck's Vioxx gastrointestinal outcomes research study, dubbed "VIGOR." That study found that Vioxx users were up to five times more likely to have heart attacks or strokes than users of Naproxin, another anti-inflammatory pain reliever.

One memo, dated Feb. 9, 2001, told sales representatives, "Do not initiate discussions" on VIGOR.

Instead, according to company documents that Merck submitted to the committee, Merck's sales staff was instructed to give doctors "cardiovascular cards"—promotional materials that asserted Vioxx was safe for the heart. The cards cited and summarized findings from previous clinical trials on Vioxx conducted prior to its FDA approval in May 1999.

But an FDA official, whom Waxman didn't name, said those studies had no relevance on the cardiovascular safety of Vioxx. The FDA official, Waxman said, added that it was "ridiculous and scientifically inappropriate to use the data in the way Merck did."

Dennis Erb, Merck's vice president for global strategic regulatory development, disagreed. He said company sales representatives gave doctors "accurate, balanced and fair" material about Vioxx.

Erb said he believes in the safety of Vioxx and added that Merck is in discussions with the FDA to allow Vioxx back on the market.

"I feel very positive about the safety profile of Vioxx," Erb said.

Erb denied trying to deceive physicians. He said Merck's sales force couldn't discuss the VIGOR study with doctors because company policy allows them to discuss only information that's been approved by the FDA for the drug's product label.

He maintained that doctors were informed about the VIGOR study through news accounts and articles in medical journals.

"The cardiovascular results of VIGOR were widely reported and discussed at the time. We worked diligently with the FDA to review the data and develop revised prescribing information," Erb testified.

Doctors who wanted more information about the study only had to request the material from the company, Erb said. About 133,000 did so, he added.

But even after an FDA advisory committee recommended in April 2001 that doctors should be advised about the findings of the VIGOR study, Merck sent a bulletin to its representatives urging them not to "initiate discussions on the FDA arthritis committee ... or the results of ... the VIGOR study."

"Instead of informing doctors about the risk of Vioxx," Waxman continued, "Merck told its reps to continue to rely on the highly questionable cardiovascular card."

Waxman said the 20,000 pages of documents that Merck submitted to the committee show that "health risks were viewed as obstacles that the sales force was instructed to surmount."

To view the Merck sales documents, go to: http://www.democrats.reform.house.gov/story.asp?ID=848.

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(c) 2005, Knight Ridder/Tribune Information Services.

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