Pieces of a puzzle: Multaq, Sanofi, ACC, HRS, Prystowsky, AF Guidelines

CardioBrief today dispenses with its usual format. Our post today is a puzzle. Here are the various pieces of the puzzle:

Puzzle Piece 1: The commercial prospects of Multaq (dronedarone) appear increasingly cloudy, according to a news report by Jim Edwards on bnet.com. Wall Street estimates for the drug, which some had thought might reach € 3 billion, have been drastically reduced, with at least one analyst stating it will never sell more than €300 million a year for its maker, Sanofi-Aventis.

Puzzle Piece 2: The ACC and the Heart Rhythm Society (HRS) have jointly launched AFibProfessional.org, which they define as “a unique collaboration to address atrial fibrillation for the cardiology community.” The Sanofi logo appears in the lower right hand corner under “site sponsors” (no other companies are listed). There is no mention of sponsorship, or the role of the sponsor, anywhere else in the site that I can find.

Puzzle Piece 3: As far as I can tell, with one exception all the educational content on the site is drawn from material previously available on the HRS site and the ACC’s CardioSource. Here’s the exception:

Eric Prystowsky provides a “Learn From the Experts” lecture with slides on “Managing Atrial Fibrillation: Rate Control vs. Rhythm Control.” Prystowsky delivers a talk in which he makes a beguiling case for the off-label and off-guideline use of dronedarone. He criticizes the FDA labeling for the drug and makes recommendations that differ from the label. “I want to stress this is my own personal reorganization of the algorithm and it’s not at all sanctioned by the ACC or the HRS,” he says.

In the absence of more substantive data, Prystowsky relies on subgroup analysis, nonrandomized comparisons, and secondary endpoints to bolster his case for broader use of dronedarone. At no point in his talk, in his slides, or on the website is there any Conflict of Interest disclosure for Prystowsky.

Update, Friday, March 26: The Prystowsky lecture was removed from AFibProfessional.org sometime following the original publication of this post.

2nd Update, Wednesday, March 31: The Prystowsky lecture has now reappeared on AFibProfessional.org, this time accompanied by a full disclosure form.

For much more on this subject see our followup story: More Multaq: Prystowsky whack-a-mole, ACC responds, Sanofi overtures to EPs.

Puzzle Piece 4: AF Stat Call to Action is s glossy new site with lots of resources on AF, including an iPhone app. Here’s text at the bottom of the page:

AF Stat™ A Call to Action for Atrial Fibrillation is an initiative sponsored by sanofi-aventis U.S. LLC. Some healthcare professionals and experts providing information on this site are retained and compensated for their services by sanofi-aventis U.S. LLC.

It probably won’t come as a surprise to learn that Eric Prystowsky is the “Medical Chair” for AF Stat.

Puzzle Piece 5: Eric Prystowsky has been a writing committee member for the ACC/AHA/ESC Guidelines for the Management of Patients with Atrial Fibrillation. The AF guidelines were last published in 2006. A focused update is scheduled to be released this fall.

Solving the Puzzle: To summarize: the only piece of original content on an ACC/HRS site sponsored by Sanofi is an off-label and off-guideline promotional lecture by a key opinion leader who also works directly for a Sanofi promotional site.

Let me be clear: I have nothing against dronedarone. As a journalist I’ve covered the drug’s development, clinical trials, and approval process. I think it’s unclear what kind of role the drug will ultimately play in clinical practice, and there is a legitimate need to provide educational content to physicians about the drug. But this content needs to be balanced. The presence of this expert lecture as the only piece of original content on the site represents a major imbalance and a serious compromise to educational principles. You would never know from Prystowsky’s talk that a substantial proportion of the medical community is much more skeptical about the drug’s prospects. In a poster at the ACC, for instance, Cingolani et al (led by Sanjay Kaul) performed a meta-analysis and concluded that dronedarone should only be used as a second or third line agent in carefully selected patients.

Eric Prystowsky may well end up being 100% vindicated in his positions about the drug. (I certainly would never engage him in an argument about AF!) But there is absolutely no justification for the lack of disclosure by Prystowsky at any point in his presentation, and there is absolutely no excuse for the ACC and the HRS not to have implemented safeguards to prevent this sort of lapse. Given its role as the debut lecture on a newborn site, a defiiciency like this bodes ill for the future integrity and reputation of the site, and suggests that the commitment to generating the highest quality content may take a back seat to promotional concerns.

In the recent debate at the ACC in Atlanta over conflict of interest between Bob Harrington and Steve Nissen, Harrington (who was defending relationships with industry) argued for a model in which multiple companies would support educational initiatives like AFibProfessional.org, but these companies would have absolutely no involvement in the generation of content. The debut of AFibProfessional.org appears to confirm Harrington’s point, since it seems clear that whoever is responsible for generating content on the site was more concerned about pleasing the sponsor than generating a genuine educational plan.

And just who is responsible for the content on the site? It’s not too surprising that with one exception the site contains no names of editorial staffers or anyone else responsible for the content or management of the site. (Kenneth Ellenbogen is listed prominently as the editor of the site, although there is no other indication of his role.) In general, journals and other publications and websites with a legitimate interest in producing valuable content include the names and titles of the people who produce the product. Ads and PR campaigns are almost always anonymous.

Click here for previous CardioBrief coverage of dronedarone.