Last November 16, an expert panel meeting was held at the Omni Shoreham Hotel in Washington, DC, to review the results of the infamous Enhance trial that was designed to boost the prospects of the Vytorin cholesterol pill jointly marketed by Schering-Plough and Merck. The panel consisted of five outside experts and 11 employees of the drugmakers, which are being investigated by the House Energy and Commerce Committee for allegedly manipulating the trial data in order to maintain the multi-billion-dollar Vytorin cash cow.

But the meeting notes contain a plethora of inaccuracies, exaggerations and questionable assertions by the drugmakers, according to notes written in the margins by Jim Stein, a University of Wisconsin cardiology professor and one of the outside experts. The notes and related e-mails were released this afternoon by the House committee. (Here are the notes and e-mails).

In an e-mail to Schering-Plough’s John Strony, Stein writes that he initially was led to believe there were no meeting minutes so everyone could speak freely and remarks would “not get back to” John Kastelein, the primary investigator. But after reviewing what he calls an after-the-fact, “incomplete summary,” which claims Kastelein “recused himself” from the meeting, Stein adds that some statements “do not fit my recollection” and that he can’t approve them. An example - the ‘minutes’ say the panel decided to change the primary endpoint, when Stein says it was the drugmakers.

He then says “some parts of the minutes do not accurately reflect the divergence of opinions at the meeting…and do not accurately reflect the detail of the deliberations. The overall tone of the minutes makes it seem as if the conclusions presented were strong, unanimous scientific recommendations of the panel, when they were really opinions of varying degrees of enthusiasm from individual panel members, varying degrees of scientific justification and varying degrees of consensus.”

For instance, due to time constraints, the group could only review 50 to 75 study images of carotid arteries and “those were only images that the company chose to show us.” However, the official minutes say the outside experts had unrestricted access to all images. Stein then writes that he and another academic expert qualified their remarks to reflect the limited viewing, and these “were not a randomly selected group of images, thus they were potentially biased because they were chosen by the company to illustrate certain points.”

Stein goes on to note various points that appear to upset him, such as the “serious concerns expressed by some panel members” concerning standard deviations in images, as well as concerns about the integrity of the data. In short, the overall tone expressed by Stein is dismay and anger that the drugmakers attempted to convey conclusions that, in his view, don’t come close to representing what took place at the meeting or the opinions held by the experts.

As noted recently by Matt Herper in Forbes, the disclosure of the minutes “could also make it more difficult for the companies to defend their own decision making with regard to the study.” Now, the disclosure of the recreation and Stein’s refutations will make it still harder.

Here is a statement sent us by Schering-Plough: “Merck/Schering-Plough is cooperating with the House Energy and Commerce Committee in its investigation of matters relating to the ENHANCE study. We will respond in due course and in detail to each of the Committee’s questions.

In the meantime, however, we wish to note that the documents released by the Committee are entirely consistent with the account of the facts relating to the ENHANCE study that we have given to the public and to the Committee staff. In particular, the draft and final minutes of the expert panel meeting on November 16, 2007, make clear that there were significant scientific and technical questions presented by the analysis of the data from the ENHANCE study. Efforts to deal with those questions, and to ensure the accuracy of the final results, were the reason the study results were not released until January 2008. The study remained blinded until shortly before that date.

MSP circulated drafts of the minutes to all of the panel members, and the final version reflects their comments. The consultation process added several weeks to the time required to prepare the final minutes.

Dr. Michiel Bots, who wrote an earlier expert report referred to in the Committee’s letter, participated as a member of the expert panel, so the panel members had the full benefit of his views. At his own request, the principal investigator, Dr. John Kastelein, did not participate in the expert panel meeting (but nominated panel members), so that the panel could provide a candid assessment of issues relating to the data from the study.”