Health News

Lawmakers: Doctors Misled on Vioxx Safety

May 5, 2005 -- An aggressive marketing campaign by the drug manufacturer Merck appears to have misled doctors about the safety of Vioxx even after information about its health risks was known, a House committee investigation concluded Thursday.

The investigation, based largely on company documents, suggests that Merck instructed its sales force in 2001 to minimize growing concerns about risks associated with Vioxx. The painkiller was pulled from the market in September 2004 because of evidence that it raised the risk of heart attacks and strokes.

The strategy, named "Project Offense" in company documents, appeared intended to counter questions about Vioxx's safety. It included the wide distribution by company representatives of information suggesting to doctors that Vioxx was many times safer than other anti-inflammatory drugs, even after a large study in 8,000 patients showed that it was not.

Merck officials defended their marketing materials as accurate and said that results of the large trial, called VIGOR, had been widely disseminated in medical journals and in the media after it was completed in 2001.

But lawmakers of both parties attacked the company for intentionally misleading doctors, who with their prescribing pads were the final gatekeepers for the nearly 100 million Vioxx prescriptions issued by the time the drug was pulled from pharmacy shelves.

"When it comes to the one thing the doctors most needed to know about Vioxx -- its health risks -- Merck's answer seems to be disinformation and censorship," said Rep. Henry Waxman (Calif.) the senior Democrat on the House Committee on Government Reform.

Drug companies spend billions of dollars on lunches, trips, educational events, and direct office visits, all designed to gain doctors' favor in prescribing company products. Lawmakers also said they would request marketing information from other drug makers and may hold more hearings on the issue.

Committee members focused on several Merck documents instructing sales representatives to treat doctors' questions about Vioxx's safety as "obstacles," to avoid discussing reports of elevated heart risk, and to focus instead on the drug's benefits.

Company employees were armed with a card for doctors summarizing general safety data for Vioxx. The card, based on combined data from several different studies, strongly suggests that Vioxx is far safer than other anti-inflammatory drugs, including ibuprofen.

The card says the death rates from other anti-inflammatory drugs were 11 times higher than with Vioxx. It also says death from heart causes was eight times higher with other anti-inflammatory drugs.

The card was used extensively even after the completion of the VIGOR trial. That study showed that approximately 4,000 patients taking Vioxx were four to five times more likely to have heart attacks or strokes than 4,000 others taking the anti-inflammatory drug naproxen. The study, completed in 2001, led the FDA to add new safety warnings to Vioxx's labels and eventually became the backbone of data that led to its withdrawal from the market.