Questions raised about Vioxx promotion

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Merck & Co. instructed its sales staff to downplay safety issues of the pain drug Vioxx, according to documents released by a U.S. House Committee Thursday.

The material indicates that Merck continued to distribute information claiming the drug was safer than other pain medicines even after studies suggested the opposite.

“Merck says the mission of its 3000-person sales force is to educate doctors...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,” said Democratic Rep. Henry Waxman of California, at a House Government Reform Committee hearing on its 6-month investigation.

The hearing came on the same day Merck announced the departure of longtime President and CEO Raymond Gilmartin, although it was unclear if the two events were related.

Included in 20,000 pages of documents Merck provided to the committee was a “cardiovascular card” sales representatives were instructed to use when physicians asked about possible ill effects of Vioxx.

The card—actually a pamphlet—suggested that patients taking Vioxx “were 11 times less likely to die than patients on standard anti-inflammatory drugs, and 8 times less likely to die from Heart attacks and Strokes," according to a summary of the documents.

Waxman said his staff met with an FDA drug reviewer this week, who called the information contained in the card “ridiculous” and “scientifically inappropriate.”

At the hearing, Dennis Erb, Merck Vice President for Global Strategic Regulatory Development, defended the card, saying the information was based on data submitted to FDA for Vioxx’s original approval.

“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 told the committee. “And we promptly disclosed the results of those studies to the FDA, physicians, the scientific community, and the media,” he said.

FDA’s Steven Galson, acting director of the Center for Drug Evaluation and Research, also indirectly defended Merck’s use of the data. While newer information clearly showed different results, Galson told the committee, the newer information was not yet part of the Vioxx label, so there was nothing illegal about Merck’s continuing to rely on older studies.

“As a regulatory agency, we have to follow the letter of the law and the regulations,” he said.

But that did not sit well with some members of the committee. “Just who is the FDA protecting?” asked Republican Rep. Gil Gutknecht of Minnesota, a longtime critic of the agency.

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