Friday, July 10, 2009

Dr. Allen Taylor Offers Some Insights -- On Arbiter 6-HALTS Early Termination


After the debacle of arguably delayed-disclosure that was ENHANCE, and the debacle or prematurely trumpeted disclosure that was SEAS -- Dr. Allen Taylor has chosen to keep his study disclosures on a more sensible, and scientifically-sound, course. His approach to handling study results (including early terminations), looks positively "old-school" -- in the best of ways. Here is what he told CardioBrief (do go read it all), just yesterday:

. . . .Taylor provided some clarification [regarding the Peter Loftus] DowJones story which stated that Taylor "said more information might be provided at a later date," Taylor told CardioBrief: "Data will be publicly disseminated in a scientific forum at the earliest possible time."

Asked about Abbott’s role in the trial, Taylor wrote: "Abbott played/plays no role other than funding support through an independent third party foundation."

Finally, Taylor emphasized that the steering committee is strongly in favor of limiting speculation about the trial: "We made a committee decision to solely utilize the NIH website for our public disclosure -- the intent is to limit speculation/manage expectations in favor of future, more substantive communications. . . ."

[From Dr. Taylor's writings on SEAS:]

". . . .The manner of release of the SEAS trial and the unblinding of two other ongoing trials raises important questions about the scientific process in an era of mass media communications. Premature release of data via a highly orchestrated media event does not serve the scientific community well. Premature unblinding of ongoing trials for commercial purposes is highly undesirable and compromises the integrity of these studies. Finally, approval of a first-in-class drug on the basis of biochemical surrogates is fraught with hazard. The ultimate price may be widespread utilization of agents that lack a favorable balance between safety and efficacy. . . ."

So -- as a responsible scientist, Dr. Taylor has elected to prevent any of these companies from making "a highly-orchestrated media event" of Arbiter-6 HALTS. [Although, to be fair, I guess the journalists have done-so, anyway -- in some respects.]

Now we will all have to wait, and see, what the peer-reviewed journal articles have to say about why Arbiter 6-HALTS was terminated, early. Well-done, Dr. Taylor -- as sanity, in scientific disclosure -- makes an (at least partial) comeback.

1 comment:

Anonymous said...

Speculating sure is a fun parlor game, though, no?