Vytorin expert panel minutes released

For those following the Vytorin issue: The Committee on Energy and Commerce that has been investigating the ENHANCE trial documents issued a press statement yesterday, saying it had written the CEO of Schering-Plough Corporation and Merck & Co, Inc., requesting additional information about the ENHANCE study trial after uncovering in company documents “serious concerns about the handling of the ENHANCE trial and the release of its results,” according to Rep. John Dingell, committee chairman.

A 70-page file of attachments [available here] from the Committee was also made public. It contains copies of a document prepared by the company, labeled as minutes for that expert panel meeting from November 16, 2007 (in which the company had reported as advising them to change the study’s primary endpoint). But the minutes were created after the congressional investigations began. No minutes had been kept of the meeting and the panelists had been told they would remain anonymous and their comments not be made public so that they could speak freely. In fact, in one document, company executives had assured the science panel members that the minutes would not be made public.

The company’s draft version of those minutes was later distributed by John Strony at Schering-Plough on December 19,2007 to the panel members for comment. Among the Congressional Committee documents is an emailed response to the company from panelist, Dr. James Stein, a cardiac-imaging expert at the University of Wisconsin. He objected to the company’s version, saying it didn’t accurately reflect his recollection of the meeting and that the minutes “do not accurate reflect the divergence of opinions expressed at the meeting:”

This really overstates our recommendations. We did not vote on this... The tone here implies that we strongly recommended this when in reality, we just advised you on what the scientifically valid approaches would be. It was the decision of the company to change the endpoint...

The overall tone of the minutes makes it seem as if the conclusions represented strong, unanimous, scientific recommendations of the panel, when they really were opinions with varying degrees of enthusiasm from individual panel members, varying degrees of scientific justification, and varying degrees of consensus.

On January 3, 2008, Dr. Stein also returned a copy of the company’s minutes with numerous comments in the margins detailing his objections and concerns of misrepresentations and omissions (see pages 2 - 17) and his final statement: “Given these considerations, I cannot “OK” or “approve” this document.”

Still, the extensive minutes and Power Point illustrations provide some insights into the scientific and medical issues discussed at the meeting.

Also included in the Congressional Committee documents released yesterday (see pages 67-70) is a January 23, 2008 letter from the FDA to the senior director in the medical/legal office of Merck & Co., requiring the company to change its advertising copy within 90 days to correct “misleading” leading statements by adding “in consumer-friendly language, communicating not only that Vytorin contains two medications (Zocor and Zetia), but also by conveying that taking the combination drug Vytorin has not been shown to provide any additional cardiovascular outcome benefits compared to using Zocor alone.”

And, reminding everyone that nothing is confidential, also included in the papers released by the Congressional investigation committee were company emails that, well, let’s just say weren’t very becoming.

There will, no doubt, be more to come from the ongoing Congressional investigation.