A House committee implied today that Merck and Schering-Plough were aware months before they issued preliminary results of the ENHANCE study in a press release that the trial was negative.
The committee made public several anonymous emails posted on an industry chat site suggesting knowledge up to nine months before release of the preliminary data that ezetimibe/simvastatin (Vytorin) had fared no better in the trial than simvastatin alone for familial hypercholesterolemia.
The preliminary results, disclosed in the press release on Jan. 14, suggested that the combination reduced LDLs by 58%, but with no significant reduction in atherosclerotic-plaque progression.
The press release had been preceded by questions from the committee about why it took nearly two years to obtain results from the study, which ended in April 2006. The committee alleged that the companies were intentionally withholding the results of the ENHANCE study.
At an FDA press conference on Jan. 25, where the agency announced it will review the safety and efficacy of ezetimibe/simvastatin, John Jenkins, M.D., director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, said the data were not unblinded until December 2007, a delay that he said was not unusual in “a complicated trial.”
Now Rep. John D. Dingell (D-Mich.), chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak (D-Mich.), chairman of the Oversight and Investigations Subcommittee, have revealed what they say are emails suggesting the companies knew of the trial’s bottom line as early as last April.
The emails on a Web site called cafepharma.com, said the committee, included anonymous posts that state:
April 13, 2007 “Have a buddy at [Schering-Plough Research Institute]. He says the study is a bust. Adding Zetia to already maxed-out statin is useless.”
June 3, 2007 “Heard it crashed and burned.”
Sept. 10, 2007 “One of my docs is a very good friend of the PI overseas. I’m told that the study IS negative in that there is absolutely no difference in carotid IMT between simva 80+placebo vs. simva 80+Zetia 10.”
Nov. 14, 2007 “Word of mouth from investigators involved in running the trial is that it’s a negative study. We and Merck both talked up this study publicly a bunch before the results were known internally. Now both are stone cold silent.”
The committee sent letters to Cafepharma and both pharmaceutical firms asking for details and explanations.
A Merck spokesperson said the company will cooperate with the committee. “Merck stands by the safety and efficacy profiles of both Zetia and Vytorin,” the spokesperson said. “The company acted with integrity and in good faith in this clinical trial.”