Healthy Skepticism Library item: 17504

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
A Sanofi Drug, A Web Site & Lack Of Disclosure
Pharmalot 2010 Mar 29
http://www.pharmalot.com/2010/03/a-sanofi-heart-drug-a-web-site-lack-of-disclosure/

Full text:

File this under fabulous marketing. The recently launched Multaq drug for atrial fibrillation received some unusual treatment from the American College of Cardiology and the Heart Rhythm Society, which teamed to launch a new web site devoted to treating atrial fibrillation. As noted by CardioBrief, the Sanofi-Aventis logo appears in the lower right hand corner under “site sponsors” and no other companies are listed, but there is no specific mention of sponsorship, or the role of the sponsor.
Here’s where it gets interesting. Last week, the site featured a “Learn From The Experts” lecture by Eric Prystowsky who showed slides on managing atrial fibrillation and made a case for off-label and off-guideline use of Multaq, CardioBrief writes. He “relies on subgroup analysis, nonrandomized comparisons, and secondary endpoints to bolster his case,” criticized FDA labeling and made recommendations differing from the label, while stressing these were his own views. Meanwhile, another new site called AFStat Call To Action is sponsored by Sanofi-Aventis and Prystowsky is the medical chair (see here), although there is no mention that he is a Sanofi consultant (see here and here).
As CardioBrief argues, the only new and original info in the lecture appeared to be off-label discussion by a consultant to Sanofi-Aventis, whose drug was touted as a potential blockbuster but got off to a slow start last fall and, meanwnhile, reimbursement in France is now unclear (look). What’s more, after the lecture was disclosed, the ACC and HRS late last week yanked Prystowsky’s lecture (see here), although he hasn’t disappeared altogether – you can watch him here.
In response, an ACC spokesperson tells CardioBrief that it plans to ‘conduct an internal meeting’ to clarify policies and procedures for non-CME offerings. Meanwhile, Sanofi tells Bnet that it had no control over the content. That may be so, but this is also an all-too-convenient reply. And the episode points out a few problems: there is only one corporate sponsor for this educational undertaking; there was a lack of disclosure concerning the key lecturer and the sponsor; there was apparently a lack of additional info being discussed by the medical community; and the only person who is listed as responsible for content on the site, editor Ken Ellenbogen, is also a Sanofi consultant (see here). Bottom line: the credibility of all the organizations involved is undermined.