Merck, Schering-Plough Offer Explanation For Delay In Release Of Vytorin Study Results

Merck and Schering-Plough recently offered a detailed explanation of their decision to delay the release of the results of a study of the cholesterol medication Vytorin, the Wall Street Journal reports. The study, called Enhance, ended in April 2006, but the companies did not release the results until Jan. 14 (Winslow/Wilde Mathews, Wall Street Journal, 1/26).

The study found that Vytorin is no more effective than a medication available in generic form in the prevention of accumulation of plaque on artery walls. For the study, 720 participants took either Vytorin -- a combination of Zetia, which blocks absorption of cholesterol in the intestines, and Zocor, a statin available in generic form -- or Zocor alone. The two-year study found that participants who took Vytorin experienced a 58% decrease in their LDL cholesterol levels, compared with 41% for those who took Zocor. However, the study found no statistically significant difference in the accumulation of plaque on artery walls among participants who took Vytorin and those who took Zocor (Kaiser Daily Health Policy Report, 1/17).

The companies attributed the delay in the release of the results to efforts to ensure accuracy of imaging data collected during the study. The companies in late 2005 raised concerns about the quality of the imaging data. In subsequent months, the companies established a plan to reanalyze the images that included the establishment of two panels of outside experts to discuss the issue. In January 2007, one expert said the concerns about the quality of the imaging data were similar to those in other studies, but the companies decided to continue with the plan. The companies also said that the results of the study were "blinded" throughout the process and that they remained unaware of whether the results were positive or negative until Dec. 31, 2007.

According to the Journal, "Critics said that, despite the recounting, they didn't fully understand why the companies spent so long working on the data," and the "affair shows the problems that can arise when corporate sponsors, rather than independent academic investigators, control how a study is run" (Wall Street Journal, 1/26).

Additional Developments
Summaries of several developments related to the results of the Vytorin study appear below.
FDA recommendations: FDA on Friday said that patients should not end treatment with Vytorin immediately based on the results of the study, CQ HealthBeat reports. According to FDA officials, the study does not indicate that Vytorin is ineffective. They added that patients who take Vytorin should discuss whether they should switch medication with their physicians. FDA officials also said that the agency will review the results of the study, with results expected in six months (Lubbes, CQ HealthBeat, 1/25).














New York investigation: The office of New York Attorney General Andrew Cuomo (D) on Saturday announced that he has sent subpoenas to Merck and Schering-Plough as part of an investigation into the delay in the release of the results of the study, the Journal reports. The investigation seeks to determine whether the company "deliberately concealed" results of the study. Both companies said that they have received the subpoenas and will cooperate with the investigation (Rubenstein, Wall Street Journal, 1/28).

Lawsuits: Merck and Schering-Plough face at least 10 federal lawsuits over allegations that the companies "reaped billions of dollars in profits" through their delay in the release of the results of the study, the Philadelphia Inquirer reports. The lawsuits -- filed in California, Colorado, New Jersey, New York and Ohio -- allege that the delay prompted patients to purchase Vytorin, rather than a lower-cost, generic version. Skip Irvine, a spokesperson for the companies, said that they plan to fight the lawsuits (Stark, Philadelphia Inquirer, 1/26).

Patient response: Many patients who are "dismayed by recently released research" on Vytorin "have been asking their doctors what to do," the Arkansas Democrat-Gazette reports. According to the Democrat-Gazette, many physicians are "keeping their patients on Vytorin, while others have made changes." The American College of Cardiology has recommended that physicians not make "major clinical decisions" based on the results of the study, and the American Heart Association has recommended that patients consult with their physician before they end treatment with Vytorin (Tubbs, Arkansas Democrat-Gazette, 1/28).

Opinion Piece
"The idea that cholesterol plays a key role in heart disease is so tightly woven into modern medical thinking that it is no longer considered open to question," but based on the results of the Vytorin study, scientists should "question the role of LDL cholesterol in heart disease," Gary Taubes -- author of "Good Calories, Bad Calories: Challenging the Conventional Wisdom on Diet, Weight Control and Disease" -- writes in a New York Times opinion piece.

Taubes writes, "If the evidence continues to challenge the role of cholesterol, then rethink it, without preconceptions, and consider what these other pathways in cardiovascular disease are implying about cause and prevention." He concludes, "A different hypothesis may turn out to fit the facts better and one day help prevent considerably more deaths" (Taubes, New York Times, 1/27).


Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.


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