Several Additional Perspectives -- Dr. Califf's "Special Report" in NEJM, Tonight. . . .

TheHeart.org is running a piece, this evening. I'll have some analysis, this weekend, of whether new rules are the answer to the supposed SEC angle on the story. I think more robust independence clauses in the clinical trial agreement, between the PI, and the corporate sponsor, might be a better starting place -- so that Dr. Califf would not have felt "forced" by Schering-Plough's lawyers, to disclose the IMPROVE-IT data, at the level of detail he ultimately did.

This, in turn, then allowed Schering-Plough to smooth-over the rougher patches in the SEAS data, is clearly the implication, here. And for the record, it was CEO Hassan's earlier laudatory comments [on Vytorin/Zetia's efficacy] that arguably put the Kenilworth SEC lawyers behind the 8-ball (to the extent they ever actually were). TheHeart.org snippet, then:

. . . .The unusual and controversial history of the cholesterol-lowering drug ezetimibe (Zetia, Merck/Schering-Plough) is the subject of special report in the August 13, 2009 issue of the New England Journal of Medicine, with experts pondering the current state of clinical trials, particularly the premature release of data in an environment where companies feel compelled to alert shareholders about bad news early and where clinical investigators want to present these data in a scientific forum or peer-reviewed journal.

"There are real or perceived interpretations of the [Securities and Exchange Commission] SEC regulations by companies who are involved in sponsoring clinical research, whereby they believe they have material information and they are obligated to release some aspect of that to the public," Dr Robert Harrington (Duke Clinical Research Institute, Durham, NC), an author of the report, told heartwire. "Typically, if it's a trial done where there is an academic group involved and where people might like to see that data presented at a medical meeting or in a high-quality journal, there is a fine line between releasing qualitative information and quantitative information. . . .

"People are chirping about companies and the SEC, but let's talk about all sides of equation," he said. "I would love nothing better than to have a system where everybody agrees—the companies, the journals, the meetings—about the most appropriate way to lay out data. We don't have a perfect system. . . .

Later, FierceBioTech ran this:

. . . .The premature announcement of the SEAS results and the down pour that resulted prompted the early release of data from two other Merck/Schering-backed Vytorin studies--SHARP and IMPROVE-IT. Researchers claimed data from the studies showed that cancer risks presented in the SEAS data were likely the result of chance. The principal investigator for one of those studies, Robert M. Califf, MD, now says that, after the SEAS results were released, he and his fellow researchers at the Duke Translational Medicine Institute were forced into announcing results from the two related studies prematurely to reassure their trial participants that Zetia did not promote cancer. . . .

As ever, more to come. . . .