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Did Sanofi Sponsorship Push the Legal Envelope on Its Disappointing New Heart Drug?

The pressure to make the new heart drug Multaq a success appears to be getting to Sanofi-Aventis (SNY): The company sponsored a Web site containing recommendations that the drug be used for unapproved, "off-label" uses -- a potential violation of FDA regulations.

The content was yanked from the site today, but before it disappeared into the memory hole it was noted by Larry Husten of Cardiobrief. Sanofi initially forecast that Multaq, for atrial fibrillation (abnormal heartbeats), could make as much as $1.32 billion (€1 billion) a year in revenues. But sales of the drug are so slow that it looks like it may never break €300 million. Wall Street is becoming unhappy about that.

Sanofi sponsored an atrial fibrilliation specialist web site, featuring content drawn from the American College of Cardiology and the Heart Rhythm Society. One section, "Learn From the Experts," is currently devoid of content. It used to contain a slideshow by Eric Prystowsky (pictured) titled "Managing Atrial Fibrillation: Rate Control vs. Rhythm Control," according to Cardiobrief:

Prystowsky delivers a talk in which he makes a beguiling case for the off-label and off-guideline use of dronedarone [the chemical name for Multaq]. 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.

The reason "subgroup analysis, nonrandomized comparisons, and secondary endpoints" are regarded with skepticism is because they are the equivalent of cherry-picking from the data the bits you like after discovering that the totality of the data doesn't say what you wanted it to say.

In an amazing coincidence, Prystowsky is a consultant and advisor to Sanofi, which you can see here and here. It's illegal for drug companies to pay doctors to promote off-label uses for their drugs -- so I'm sure that can't possibly be the case here.

A representative for Sanofi said the company had no control over the site's content:

This is independent of Sanofi ... we sponsor a lot of professional associations and we are very transparent about funding for those organizations, and that's the case here.
Correction: The original headline suggested Sanofi was directly responsible for the site's content. It has been changed to reflect Sanofi's position that that's not the case. Related:
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