The House Energy & Commerce Committee intends to keep hounding Merck and Schering-Plough for data and internal communications on how the company handled the release of information from three trials on Vytorin (simvastatin/ezetimibe).

The committee telegraphed its interest in pursuing its detailed hunt through Merck and Schering records in a February 16 letter to both companies.

The letter asks for a broad range of information related to three trials: SEAS (Simvastatin and Ezetimibe in Aortic Stenosis), SHARP (Study of Heart and Renal Protection), and IMPROVE-IT.

The extensive document request focuses on records and communications related to the Drug Safety Monitoring Boards for the trials.

The stated premise of the investigation is that the companies were involved in getting the DSMBs from SHARP and IMPROVE-IT to release safety data prematurely.

"We are writing to request information about the decisions by the Drug Safety Monitoring Boards to unblind the interim data from SHARP and IMPROVE-IT," the committee said.

The practical significance of the letter, however, is to put the companies on notice that House Energy & Commerce Committee investigator Paul Jung is keeping Vytorin on his active list of investigations.

Jung is the only investigator staying through the transfer in leadership from previous committee chairman John Dingell, D-Mich., to Henry Waxman, D-Calif.

The committee has requested information on Vytorin at least four times previously (¹ Also see "Will Vytorin Fallout Include ENHANCEd Reporting Requirements For All Trials?" - Pink Sheet, 21 April, 2008., p. 3).

Following a review of e-mails related to the ENHANCE trial, the committee released selections of internal communications which showed disagreements between Merck and Schering and comments among members of a special panel assembled by the companies to review the trial results.

The most recent request is again asking for a large body of notes, e-mails and minutes. The committee is asking for all communications among DSMB members, steering committees and corporate liaisons.

Jung, an MD, MA, MPH and MBA, is an aggressive investigator of pharma. He has been on special assignment to the committee from the Public Health Service. He worked on the Clinton health care reform task force in the early 1990s and has co-authored a paper with Public Citizen Director Sidney Wolfe on criminal activity of physicians.

- Cole Werble (c.werble@elsevier.com)

House Energy & Commerce To Continue Foraging Through Vytorin Data

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