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Vioxx Risks Not Part of Sales Pitch, Files Reveal


Los Angeles Times
May 6, 2005
By Ricardo Alonso-Zaldivar, Times Staff Writer

Merck & Co. ordered its representatives not to talk to doctors about studies that showed the painkiller could cause heart attacks.

WASHINGTON — Four years ago, as evidence mounted that Merck's blockbuster painkiller Vioxx could cause heart attacks, the company ordered its sales force not to discuss the emerging data with doctors, but instead to paint a reassuring picture of minimal risks, according to documents released Thursday at a congressional hearing.

The documents open a window into the supercharged world of drug company marketing — where gestures as small as a handshake were scripted to boost sales.

"This sales force is given extraordinary training so that it can capitalize on virtually every interaction with doctors," Rep. Henry A. Waxman (D-Los Angeles) said of Merck's 3,000 sales representatives. "Yet 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."

A company bulletin from 2001 ordered the sales force to steer clear of discussing a scientific meeting convened by the Food and Drug Administration to evaluate Vioxx safety. "DO NOT INITIATE DISCUSSIONS," it said in a prominent warning.

In other internal missives, concerns about heart risks were termed "obstacles." A sales campaign to overcome the safety concerns was called "Project Offense." Another was dubbed "Project XXceleration" — a play on the spelling of the drug.

Coincidentally, Thursday's hearing before the House Government Reform Committee came the day Merck & Co. announced that longtime Chief Executive Raymond Gilmartin was stepping down. The company's voluntary recall of Vioxx last fall has hammered its earnings and stock price. Company insider Richard Clark, head of manufacturing operations, will replace Gilmartin, who is to remain as a consultant.

Dennis Erb, Merck's vice president in charge of regulatory issues, told the House panel that the company had not withheld data from the medical community or the government. He described the sales presentations to doctors as "accurate and balanced."

"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," Erb said. "And we promptly disclosed the results of these studies to the FDA, physicians, the scientific community and the media."

In 2000, when its studies began to show evidence of heart risks, Merck reported the findings to the FDA. And it was additional information from a Merck-funded study that led to the company's decision to recall Vioxx.

What it did not do was include the 2000 study's indication of problems in the data on risks that its sales force showed to doctors and other prospective customers.

Merck is considering returning Vioxx to the market but has reached no decision, Erb said. The company has asked the FDA to spell out what additional information would be needed to bring Vioxx back.

The hearing may prove to be a milestone in congressional efforts to strengthen the FDA's drug safety program. Until now, some members of the Senate have focused on the subject, but the House has remained on the sidelines. After the hearing, panel Chairman Thomas M. Davis (R-Va.) said that legislation might be needed.

"I think it's an open question — it's possible," he said.

By all accounts, Merck's aggressive marketing campaign was astoundingly successful. The overwhelmingly majority of the 100 million Vioxx prescriptions dispensed in the United States were written after concerns had surfaced about heart risks, according to an analysis by the committee's Democratic staff. Vioxx reached $2 billion in annual sales faster than any previous Merck drug.

A key to the campaign was a pamphlet the company issued in April 2000 to its salespeople, dubbed the Cardiovascular Card or CV Card. It was meant to ease doctors' concerns after a Merck-funded clinical trial — called the VIGOR study — produced what turned out to be the first solid indications of potential problems.

Although Merck released the VIGOR findings, it argued that they sent a misleading signal about a nonexistent problem.

The VIGOR study found a fivefold increase heart attacks and strokes for Vioxx patients when compared to patients taking naproxen, the active ingredient in Aleve. But the CV Card failed to mention those findings. Instead, it combined data from several older studies to suggest that Vioxx patients were eight times less likely to die from heart attacks and strokes than people taking other painkillers.

Dr. John Jenkins, director of the FDA's Office of New Drugs, told the committee that the company should have incorporated the VIGOR information in its sales discussions with doctors.

FDA officials said they were unaware of the details of the marketing campaign.

Erb testified that the CV Card was created by the company's marketing department, although it would have been reviewed and approved by the legal and medical divisions as well.

Rep. Gil Gutknecht (R-Minn.) said he found the company's omission "confusing and, in some respects, embarrassing."

"No one wants to seem to want to take responsibility for putting out information that an outside observer might call … disingenuous," Gutknecht said.

Erb said the VIGOR study was not included in the pamphlet because it was not part of the FDA-approved prescribing information for Vioxx. He said it was company policy to rely on the prescribing information for such communications. He noted that information about VIGOR was publicly available.

"A wide-awake physician would have known this?" Davis asked.

"That is correct," Erb responded.

Concerns about Vioxx continued to grow. In early 2001, an FDA advisory committee recommended that doctors be informed about the potential heart complications.

But Merck's sales force was instructed to avoid such discussions. Sales representatives were told not to bring up the subject. If doctors asked about the VIGOR trial, sales representatives were supposed to encourage them to submit the questions in writing to the company's medical services department.

Erb said Merck received and answered about 123,000 such queries. But Waxman said some of the company responses merely referred back to the outdated information mirrored in the CV Card.

Although the sales force was constrained in discussing safety issues, it received detailed coaching on everything from how to shake hands with doctors (firmly, not painfully, and for three seconds) to table manners when taking physicians to lunch (eat bread in small pieces).

Merck used sophisticated databases to learn the prescribing patterns of individual doctors and set targets for selling its products to them. Sales representatives earned bonuses for increasing Merck's share of a doctor's prescriptions.

The sales representatives also attended motivational courses where they were taught not to take no for an answer. Course leaders used inspirational figures such as Helen Keller, George Washington and the Rev. Martin Luther King Jr. to encourage the sales force.

King's "I Have a Dream" speech was used as an example of effective salesmanship. Physicians would be "free at last" when they started prescribing Vioxx.

"Martin Luther King?" a flabbergasted Rep. Elijah E. Cummings(D-Md.) said. "My God, how far will we go?"

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