Kaiser Daily Health Policy Report
< ="Daily Health Policy Re" name=Topics.sup>Merck on Tuesday agreed to a million settlement with 29 states and the District of Columbia to end investigations over allegations that it downplayed cardiovascular risks caused by the COX-2 inhibitor Vioxx in direct-to-consumer advertisements dating back to 1999, the AP/Philadelphia Inquirer reports (Raffaele, AP/Philadelphia Inquirer, 5/21). Merck withdrew the painkiller from the market in 2004 after research found it doubled the risk of heart attack and stroke. The company has agreed to a .85 billion settlement, which is pending, to end a majority of the lawsuits that followed the findings, the South Florida Sun-Sentinel reports (Burstein, South Florida Sun-Sentinel, 5/20). Under Tuesday's settlement, Merck agreed to submit to FDA for seven years all new television ads for its drugs and follow through with agency-suggested changes before airing them. A spokesperson for Pennsylvania Attorney General Tom Corbett (R) said that the settlement does not require court approval (AP/Philadelphia Inquirer, 5/21).
'Medical Ghostwriting' Ends
In the settlement, Merck also agreed to end its practice of so-called "medical ghostwriting," the Wall Street Journal reports (Kingsbury, Wall Street Journal, 5/21). The Journal of the American Medical Association in April published a report that alleged Merck employees or paid consultants -- rather than the physicians listed as lead authors -- wrote several published studies on Vioxx. The report found 16 of 20 early studies of Vioxx listed the lead author as an academic researcher, although internal documents listed a Merck employee as the author of the first draft (Kaiser Daily Health Policy Report, 4/16).
FDA Oversight
The settlement "leaves unanswered concerns consumer advocates have raised about FDA oversight of direct-to-consumer drug advertisements," according to the Raleigh News & Observer. Part of the settlement is Merck's agreement to have its ads reviewed by FDA. However, according to a 2007 Pharmaceutical Research and Manufacturers of America report, most drug makers already voluntarily submit their ads to the agency. FDA warned Merck in 2001 that its ads failed to inform consumers about cardiovascular risks, but the "number of FDA enforcement actions to pull misleading drug advertisements has dropped sharply since then," according to the News & Observer. Drug makers have increased spending fourfold on DTC ads in the last 10 years, but the number of FDA warning letters has fallen 86% over the same time period, the News & Observer reports (Vollmer, Raleigh News & Observer, 5/21).