Senate probes GSK over leaked NEJM Avandia article
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| Sen. Charles Grassley, R-Iowa. Source: ABC News | |
Sen. Charles Grassley, R-Iowa, updated the Senate on the ongoing investigation questoning GSK’s involvement with the leak, which corresponded with a letter sent GSK president requesting information about its response to the leaked study.
The committee began the investigation in May 2007 when Steve Nissen, MD, at the Cleveland Clinic, published the study, which led to drop off in Avandia prescriptions and an FDA black-box warning.
Shortly after the committee began its investigation, Scott Gottlieb, MD, a former deputy commissioner at the FDA, wrote an op-ed in the Wall Street Journal, in which he implied that the congressional investigators had obtained a copy of the study before it was published.
“Dr. Gottlieb suggested that this action called into question the integrity of both congressional investigators and Dr. Nissen,” Grassley said Wednesday in his address to Senate. But Grassley insisted that “congressional investigators did NOT get a copy of the Nissen study until it became public.” However, the 2007 op-ed made the Senate aware that the study had been leaked.
NEJM picked Steven Haffner, MD, a GSK consultant, to peer review the study and he leaked a copy of the study to Alexander Cobitz at GSK weeks before it was published, Grassley said to the Senate.
“Not only did Dr. Haffner breach his agreement with the New England Journal of Medicine to properly peer review the Nissen study, but he violated practically every tenet of independence and integrity held sacred by the major medical journals,” Grassley said.
In Grassley’s letter to Christopher Viehbacher, president of GSK U.S. division, he asked “what GSK did after receiving the study. Did GSK return the study to Dr. Haffner? Did GSK contact the NEJM to report this violation of publishing ethics?”
Grassley also asked GSK when it first made contact with the data safety monitoring board of the RECORD trial to set in motion that publication, and when did the pharma company begin assembling data needed for the publication, as well as the date of submission of the data to the NEJM, which published the results online on June 5, 2007.
Haffner said, "Why I sent it is a mystery. I don't really understand it. I wasn't feeling well. It was bad judgment," in the Feb. 3 issue of Nature.
Grassley said that Haffner told his investigators that GSK did not ask for an early copy of the Avandia study, however, he said that questions still remain about the actions of the company after it received study.
In his concluding remarks to the Senate, Grassley said, “Over the last few years, my investigations have found that the Food and Drug Administration has a very cozy relationship with drug companies…I have shown that some drug companies intimidate scientists who speak up about bad drugs.”
Grassley set a Feb. 15 deadline for GSK to respond to his request.