Sen. Grassley Requests Information On Delay Of Results Of Study On Cholesterol Medication Vytorin

Main Category: Cholesterol
Also Included In: Clinical Trials / Drug Trials
Article Date: 02 Apr 2008 - 7:00 PDT

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Senate Finance Committee ranking member Chuck Grassley (R-Iowa) on Monday sent a letter to the CEOs of Merck and Schering-Plough that requested additional information about their decision to wait for more than one year to release the results of a study on the cholesterol medication Vytorin, marketed by a joint venture between the companies, the Wall Street Journal reports (Winslow, Wall Street Journal, 4/1).

The study, called Enhance, ended in April 2006, but the companies did not release preliminary results until January. Researchers on Sunday presented the complete results of the study at the annual meeting of the American College of Cardiology in Chicago, and the results also appeared on the New England Journal of Medicine Web site on the same day. According to the study, Vytorin is no more effective than a medication available in generic form in the prevention of accumulation of plaque on artery walls (Berenson, New York Times, 4/1).

Grassley and several other lawmakers have begun investigations into whether the companies delayed the release of the results of the study to protect sales of Vytorin (Wall Street Journal, 4/1). In addition, lawmakers have questioned the aggressive marketing of Vytorin during the delay (Washington Post, 4/1). The companies have attributed the delay to efforts to ensure accuracy of imaging data collected during the study (New York Times, 4/1).

E-Mail Correspondence
In his letter, Grassley included excerpts from e-mail correspondence between John Kastelein of the University of Amsterdam Medical Center, who led the study, and the companies about the delay. According to the Journal, the correspondence "reflects what ... Kastelein ... has described as a frustrating relationship over what he considered unnecessary holdups in analyzing and presenting the findings."

A July 6, 2007, e-mail from Kastelein raised concerns that the companies had decided not to have him present the results of the study last November at a meeting of the American Heart Association. In a July 7, 2007, e-mail to Rick Veltri, a vice president at the Schering-Plough Research Institute, Kastelein wrote that, as a result of the delay, "you will be seen as a company that tries to hide something and I will be perceived as being in bed with you!" (Wall Street Journal, 4/1). He continued, "Is it correct that SP has decided not to present at AHA?" (New York Times, 4/1). He wrote, "If this is true, (Schering-Plough) must have taken this decision without even the semblance of decency to consult me," adding, "I can tell you if this is the case, our collaboration is over. This starts smelling like extending the publication (of the study) for no other (than) political reasons, and I cannot live with that" (Wall Street Journal, 4/1).

According to the Times, the letter likely will "inflame the controversy over the way that Merck and Schering-Plough handled the Enhance trial, as well as their heavy promotion of Vytorin and Zetia," a cholesterol medication marketed by Schering-Plough.

Reaction
Rosemarie Yancosek, a spokesperson for Schering-Plough, said, "The e-mails selectively excerpted in the letter concern an issue that Merck-Schering-Plough and -- we believe, also Dr. Kastelein -- consider long resolved" (New York Times, 4/1). She added, "We have done nothing wrong. We stand behind our products" (Fauber, Milwaukee Journal Sentinel, 3/31). According to a Merck spokesperson, Grassley has failed to acknowledge that Vytorin can reduce levels of LDL, or "bad" cholesterol, in patients.

Kastelein on Monday acknowledged that he had raised concerns about the delay in the release of the results of the study and attempted to persuade the companies to allow him to present the results earlier. However, he did not allege that the companies delayed the release of the results of the study to protect sales of Vytorin (Wall Street Journal, 4/1).

Harlan Krumholz, a cardiologist at Yale University, said that the e-mails raise new concerns about the delay. He said, "What raises concerns here is the possibility that the delay was being imposed by the companies against the wishes of the principal investigator, who should be the leader of the study," adding, "I hope that there was a good scientific explanation, endorsed by a steering committee of credible scientists at the time of the decision to delay, which explains why the public and the profession had to wait so long" (New York Times, 4/1).

American Public Media's "Marketplace" on Monday reported the study. The segment includes comments from Krumholz, and Steven Nissen, chair of cardiology at the Cleveland Clinic (Marshall-Genzer, "Marketplace," American Public Media, 3/31). Audio and a transcript of the segment are available online.

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