More pieces of the Multaq puzzle

I don’t want to keep harping on Multaq (see the bottom of this post for links to recent stories), but then I keep running across promotions for so-called educational programs that practically beg to be scrutinized. Earlier today I received an email from theheart.org CME Center. At the top of the message was this featured CME program:

Reducing Hospitalizations in Atrial Fibrillation: Optimizing Arrhythmia Control
The purpose of this activity is to educate clinicians on strategies for switching AADs and the impact of AF recurrences on hospitalization.

Not mentioned in the email was the sponsor of the program, but it probably won’t come as a big surprise to learn that it was Sanofi Aventis. I took a quick look at the transcript of the program, which appeared to be essentially a detailed list of excuses and reasons to switch AF patients from amiodarone or other drugs to dronedarone. The heavy lifting was performed mostly by one of the participants, Peter Kowey. Here’s part of his conclusion:

So the conclusion of this analysis is that we didn’t see anything that would suggest — and again, there are so many caveats about this kind of analysis, post-hoc, small numbers, and going back into a database and drudging it is always hazardous — but within all of those limitations, we would be willing to conclude that we didn’t see anything that would make us really worried about making a switch in a relatively short period of time, except for the issues of bradyarrhythmia and QT prolongation.

The great part about this quote is that it spares me the effort of pointing out all the flaws of this kind of talk (“post-hoc, small numbers…. drudging”), although there is something a bit cavalier and disturbing about that last clause (“except for the issues of bradyarrhythmia and QT prolongation”).

To give Kowey due credit, he then makes the following statement: “we need to remember that this is a retrospective analysis. What this does when you do these kinds of things, is it kind of creates a hypothesis.”

But here’s the important point: if in fact this is just a “hypothesis” why is it being presented, completely unopposed, in a so-called educational program? Kowey’s views, like Prystowsky’s (as I discussed in my earlier post), may well turn out to be quite valid. But since as of now these can only be considered hypotheses, in a genuine, unbiased educational program they should be considered from more than one side. That’s why these programs are, finally, promotional and not educational, though undoubtedly they contain some valid educational content.

Here’s a test: when was the last time you saw a truly balanced CME program, in which both the proponents and opponents of the sponsor’s drug received equal time? (In most cases, of course, the opponents receive no time at all, but occasionally some of the more enlightened programs include a lone dissenting voice.)

Here’s a challenge to Sanofi, TheHeart.Org, ACC, HRS, and all the other medical education producers: Invite some respectable skeptics to participate in and scrutinize your “educational” programs. After all, if the purpose is not to promote anything, this shouldn’t be a problem.

Here’s a disturbing fact: All 3 participants of this CME program disclose financial ties to Sanofi. Even more disturbing: every single member of the steering committee of the “The Advances in Atrial Fibrillation” subsection of TheHeart.Org also discloses financial ties to Sanofi. (No surprise that the ubiquitous Prystowsky is also a member of this committee.)

Going back to our original puzzle regarding the ACC/HRS’s Sanofi-sponsored site, AFibProfessional.org, the editor-in-chief of the site, Kenneth Ellenbogen, disclosed that he had a “significant” (ie, more than $10,000) relationship with Sanofi with respect to both “research/research grants” and “consultant fees/honoraria.”

Personal disclosure: I was the editor in charge of all independent and unsupported editorial content on TheHeart.Org from the launch of the site in 1999 until December 2008. I had no involvement with the commercial side of the site.

Previous CardioBrief coverage:

• Pieces of a puzzle: Multaq, Sanofi, ACC, HRS, Prystowsky, AF Guidelines (March 25)
  
• More Multaq: Prystowsky whack-a-mole, ACC responds, Sanofi overtures to EPs (March 26)
  
• Prystowsky lecture resurfaces, this time with COI disclosures (March 31)
  
• Experts disagree on when to use dronedarone (Multaq) (April 6)

Click here to read a fascinating take on dronedarone from the perspective of a practicing electrophysiologist.