Sen. Grassley sends letter to Merck requesting explanation of recent JAMA reports

Sen. Chuck Grassley (R-Iowa) has sent a letter to Merck Chief Operating Officer Richard Clark requesting the company explain a recent report that found the company used employees or paid consultants rather than the physicians listed as lead authors to write several published studies of the COX-2 inhibitor Vioxx, CQ HealthBeat reports.

Grassley also requested an explanation for Merck's delay in disclosing data that showed an increased risk of death in Alzheimer's patients who took the drug (Reichard, CQ HealthBeat, 4/16).

Merck in 2004 voluntarily withdrew Vioxx from the market because of a link between the medication and increased risk for cardiovascular events. According to a report published on Wednesday in the Journal of the American Medical Association, 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. The report also found that Merck hired companies to write 72 scientific review articles and paid physicians between $750 and $2,500 to publish the articles in their own names. Fifty of the 72 article studies listed only an academic researcher as author, and only half disclosed the financial relationship between Merck and the author, according to the report. In addition, the report found "scant evidence that the recruited authors made substantive contributions" to the studies and articles.

A second report found that Merck attempted to minimize the deaths of participants in two studies designed to determine whether Vioxx could reduce the symptoms of Alzheimer's disease (Kaiser Daily Health Policy Report, 4/16). JAMA also reported that Merck delayed notifying the appropriate institutional review boards about the Alzheimer finding, according to CQ HealthBeat.

Grassley's Letter

In the letter, Grassley wrote, "These reports reveal just how far a drug maker might go to market its product and try to bury information that might hurt sales even when that information directly affected the health and safety of the people taking the their medicines." He added that if the federal government had been made aware of the findings earlier, "I am confident that the federal government would not have paid Merck $1 billion for the drug." Merck had no immediate comment on the letter, CQ HealthBeat reports.

Grassley and Senate Special Committee on Aging Chair Herb Kohl (D-Wis.) urged passage of a bill (S 2029) that would require more transparency in relationship between physicians and pharmaceutical companies. In a statement Wednesday, Kohl said, "It appears that the editors at JAMA share our fear -- that the lack of transparency is undermining the public's confidence in the integrity of their physicians" (CQ HealthBeat, 4/16).