Healthy Skepticism Library item: 13319

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Herper M.
More Questions About Vytorin Panel
Forbes.com 2008 Mar 25
http://www.forbes.com/2008/03/25/vytorin-pharmaceuticals-congress-biz-healthcare-cx_mh_0325vytorin.html?partner=yahootix

Full text:

Last November, Merck and Schering-Plough say, an expert panel advised them to change the main goal of a controversial study of their drug Vytorin. But what exactly happened at that meeting?

We may never know for sure. No official vote was taken, according to people familiar with the matter. Neither contemporaneous minutes nor a recording of the meeting was kept. That could complicate an ongoing investigation by the House of Representatives’ Committee on Energy and Commerce. But it could also make it more difficult for the companies to defend their own decision making with regard to the study.

At stake is the reputation of the companies, and exactly how cardiologists will view the results of the Vytorin study, called ENHANCE. Vytorin and its sister drug, Zetia, generated $5.2 billion in sales last year, but prescriptions have slumped because of the ENHANCE results.

The study failed to prove that the companies’ blockbuster pill Vytorin is any better at preventing heart-attack-causing atherosclerosis than a generic pill, Zocor. The panel met on Friday, Nov. 16, 2007, as Forbes was preparing a story on the long delay of the analysis of the results. The results of the study were finally released in January.

“The independent panel recommended focusing the primary endpoint to the common carotid artery to expedite the reporting of the study findings,” the companies said in a press release Nov. 19.

On Dec. 11, the companies decided not to follow that recommendation. At that point, the congressional investigation was beginning.

“We wanted a candid and frank discussion, and confidentiality can often facilitate that kind of discussion,” says a Merck/Schering-Plough spokesman. “After the meeting, we began preparing the minutes.” The work began prior to the Dec. 11 investigation, he says.

There were disagreements among the panelists over what, exactly, had occurred. The spokesman acknowledges there were “numerous revisions in order to reflect the recollections and feedback of the participants at the meeting.” But he says the final account reflects agreement by all the experts present.

The panelists, whose identities were revealed by Forbes in January, were originally meant to remain completely anonymous.

The document says no vote was taken on any recommendations, according to people who have seen a final version, but does state that members of the panel “had wide-ranging concerns about the quality of the image data.”

But the document does say the panel “was unanimous that it would be reasonable for the study team to elevate the common carotid to the primary endpoint.” That means that instead of averaging three ultrasound images from three different places in the neck for each patient, the study would focus on one, easier-to-measure spot.

However, these people say the document, which has been provided to congressional investigators, also states the panel might have made different recommendations had it been allowed to look at either randomly selected images or all of the images from the study.

The quality of the images and the meaning of the final result will be a topic of discussion when the final ENHANCE results are released at the annual meeting of the American College of Cardiology on March 30.