I think I'll do best just to encourage readers to follow all the links very helpfully provided me, by Marilyn Mann -- erstwhile occassional guest at Gooznews:
First read all of MedPageToday, here, on the topic -- then check this snippet:
. . . .A year after an analysis of early data from two ongoing trials of ezetimibe/simvastatin (Vytorin) was used to refute the possibility that ezetimibe promoted cancer, a principal investigator for one of those studies said it is time to set ground rules for premature release of data.
Robert M. Califf, MD, of the Duke Translational Medicine Institute in Durham, N.C., who, as a principal investigator for the IMPROVE-IT trial, signed off on last year's early release of data from that study, writes that at the time there was a compelling need to reassure patients in his trial that ezetimibe did not promote cancer.
But Califf's special report in the Aug. 13 issue of the New England Journal of Medicine makes it clear that he believes the decision was forced on him and his colleagues when Merck/Schering-Plough made a unilateral decision to release the findings of the SEAS trial at a press conference on July 21, 2008. . . .
This would seem to be offered, by Dr. Califf, by way of explanation and/or justification about (or defense of) Dr. Taylor's cogent observations, detailed in Point 6 of his December 2008 Circulation opinion.
Next, consider this CardioBrief reaction piece -- to Califf's NJEM perspective on SEAS. Now, once you've read it -- here's what seemed most salient to me:. . . .the authors [Califf, et al.] go on to make four broad recommendations:
1. “The requirement for independent data and safety monitoring committees should be maintained and enhanced.” Implementation of this recommendation, say the authors, requires increased support from academia and the NIH “for education in biostatistics and clinical investigation, because the supply of academicians trained in quantitative methods is dangerously insufficient.”
2. The databases for clinical trials should be housed “at nonprofit institutions whose primary mission is acting for the common good rather than returning value to shareholders,” although the authors acknowledge that academic medical centers are not without their own conflicts of interest. Further, because it would be impossible to implement this recommendation quickly, “rules governing the transparency of research data should be enhanced to make it impossible to conduct secret experiments on humans and to improve public confidence that results of studies of humans are being carefully and fairly assessed.”
3. “All major clinical outcomes trials should have independent steering committees chaired by a leader widely recognized for expertise in the field of interest and in the practical running of clinical trials. These committees should have a majority of nonindustry personnel and, together with the executive committee, should have independent access to the database at trial’s end.”4. “SEC regulations should be reformed, recognizing that clinical outcomes trials are a special case needing special rules.” [Editors' Note: With this much, I disagree. I think Schering-Plough's lawyers made several important mistakes in evaluating what the applicable SEC rules required, in the situation. But that is a post for another day -- once I have carefully thought through all the implications of Dr. Taylor's earlier work (of December 2008), and Califf's work, here tonight.] One solution, write the authors, is “to create structures for trials that facilitate database analysis without notifying company employees in a manner that would lead to incomplete release of premature data.”
Note to readers: A striking ommission from the paper by Califf et al is any mention of the ENHANCE controversy. It seems to us that it is impossible to fully come to terms with the SEAS controversy without considering the earlier and highly dramatic controversy over ENHANCE. Just as armies generally try to fight the last war in which they were engaged, much of what happened regarding SEAS was an attempt to avoid a repetition of the Dunkirk-like ENHANCE debacle. CardioBrief raised this issue with Califf, who has assured us that the authors are planning to address the ENHANCE episode in a separate paper. . . .
Again, immense thanks go to Marilyn Mann for these leads. But to be clear, again: I think Schering-Plough's lawyers made several important mistakes in evaluating what the applicable SEC rules required of them, and Schering-Plough, in the July 19 to 21 2008 SEAS "Early Release" events. But that is a post for another day -- once I have carefully thought through all the implications of Dr. Taylor's earlier work (of December 2008), and Califf's work, here tonight. Dr. Talyor deserves immense credit -- for speaking out first, and fearlessly, on the topic of orchestrated press events being no proxy for careful peer-reviewed journal authorship (recall here the Arbiter-6 HALTS termination, and his steadfast refusal to play the press game).
Much more to come, but here's my hint on the better (SEC disclosures) approach: this is from a post I wrote on July 24, 2008 -- just a few days after the "highly-orchestrated" July 21 SEAS presser, entitled "Hindsight is Always 20-20. . ."
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