• Saturday, February 18, 2012
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Merck Defends Its Relationships With Advisers

To the Editor:

I am writing to provide balance to your one-sided account entitled "University Doctors Got Paid in Drug's Sales Campaign" (The Chronicle, October 25).

First, in three separate head-to-head clinical studies, Vytorin was demonstrated to lower LDL ("bad") cholesterol significantly more than Crestor, Lipitor, and Zocor. Merck/Schering-Plough fully support the safety and LDL-lowering efficacy of Vytorin and Zetia.

The Enhance study to which your article refers was never designed or intended to evaluate clinical outcomes, as it was too small a study to allow for valid comparisons. In addition, as the U.S. Food & Drug Administration noted in a communication on the Enhance study earlier this year, "The results from Enhance do not change FDA's position that an elevated LDL cholesterol is a risk factor for cardiovascular disease and that lowering LDL cholesterol reduces the risk for cardiovascular disease. Based on current available data, patients should not stop taking Vytorin or other cholesterol-lowering medications and should talk to their doctor if they have any questions about Vytorin, Zetia, or the Enhance trial".

Instead, because Vytorin has not demonstrated an incremental benefit on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin, Merck/Schering-Plough has an ongoing 18,000-patient clinical-outcomes trial called Improve-It that is designed to evaluate patients' cardiovascular outcomes following treatment with Vytorin. We expect this study to be completed in 2012. We look forward to the conclusion of Improve-It, and continue to believe that Vytorin is an important treatment option for patients.

Second, we strongly believe that our relationships with scientific advisers and the medical communities are important to the advancement of science, medicine, education, and the well-being of patients. Likewise, our speaker programs are designed to deliver balanced medical and scientific information to health-care professionals. It's in that spirit that we support a variety of medical and scientific education initiatives for the purpose of helping health-care professionals achieve improved health outcomes for their patients. We believe that by delivering balanced medical and scientific information to health-care professionals, we contribute to this goal.

We recognize that both our reputation for integrity and the trust placed in us depend on our ethical practices. Our company and industry face many challenges in today's environment, and we will continue to actively discuss the issues in the appropriate scientific and public forums. And while we are one of the most willing and adaptable companies to change, our reputation in the industry, with patients and communities, is that of a company that puts patients first. We intend to keep it that way.

Richard C. Pasternak, M.D.
Vice President, Head Global Center for Scientific Affairs
Merck & Co., Inc.
Whitehouse Station, N.J.

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