FDA Warns Merck about ‘Misleading’ Arthritis Drug Ads
On Sept. 17, the FDA sent a warning letter to Merck & Co. "chid[ing]" the drug maker for "improper marketing" of its "blockbuster" arthritis drug Vioxx, the Wall Street Journal reports. The FDA, which warned Merck about similar practices in February, says the pharmaceutical company "misrepresented" the drug's potential cardiovascular health risks in its marketing campaign, targeted at physicians through "audio conferences, a news release and statements made at medical conferences." Specifically, the letter cites Merck for "glossing over" a possible increased rate of heart problems among patients taking Vioxx compared to those taking other nonsteroidal anti-inflammatory drugs (Adams, Wall Street Journal, 9/25). USA Today reports that in a clinical trial of 4,000 patients, researchers found that those taking Vioxx were "more than twice as likely" to suffer a "serious cardiovascular complication" as those taking the NSAID naproxen. Merck's marketing campaign has attributed those results to the "protective effect" of naproxen, implying that because naproxen can help prevent cardiovascular problems, it makes Vioxx's rate of heart problems appear artificially higher (Rubin, USA Today, 9/25).
In the warning letter, the FDA says, "In fact, the situation is not at all clear" and adds that "no adequate and well-controlled studies" exist to support Merck's theory. The letter also says the drug maker neglected to properly emphasize a potentially "serious" risk of severe bleeding caused by taking Vioxx in conjunction with warfarin, a medicine used to treat blood clots. The letter informs Merck that it must "develop a plan to immediately cease" its "particularly troublesome" promotional activities and send a letter to health care providers "exposed" to the "misleading" materials (Wall Street Journal, 9/25). The eight-page letter, sent to Merck president and CEO Raymond Gilmartin, is one of "fewer than a dozen" warning letters sent by the FDA this year, USA Today reports. The FDA has set Oct. 1 as a deadline for a response from the company. In the meantime, Merck spokesperson Chris Fanelle said, "We continue to stand by the overall and cardiovascular safety of the product" (USA Today, 9/25).