Even more questions about Multaq and Prystowsky, alas

I’m feeling a bit like Al Pacino in Godfather III: every time I think I’m out of the Multaq story I get pulled back in.

A sharp observer forwarded an article posted online in the Journal of Cardiovascular Electrophysiology: “The Impact of New and Emerging Clinical Data on Treatment Strategies for Atrial Fibrillation.” First author: Eric Prystowsky.

The simple truth is that the entire article was developed and paid for by Sanofi. The reason is very simple: Under the pretense of a comprehensive review of new data on AF, the article recommends that dronedarone (Multaq) be considered as a first line agent for all but one indication for AF across the entire cardiovascular spectrum. (This appears to be identical to Prystowsky’s position in the lecture on the ACC/HRS website.)

Here are a few further details and observations:

The following text appears in the introductory section of the paper:

The AF Exchange Group was convened to evaluate new evidence and strategies in the pharmacological and nonpharmacological management of AF, and to provide interpretation and guidance on the potential impact of such data on  the practical management of patients with AF. The Group comprises experts in fields of cardiac arrhythmias and heart failure and also in related areas of genetic predisposition, health outcomes, and epidemiology. The inaugural meeting took place on April 19, 2009, in Paris, France, at which a series of questions were discussed that highlighted key issues in the management of AF. A second meeting to discuss primarily new research on anticoagulation and stroke prevention was held in Orlando in November 2009.

Who “convened” this group? Who chose the members? How were they chosen? What role did the sponsor play in convening this meeting? (The use of the passive voice in text like this is absolutely telling.) Who else was at the meeting? Were there representatives from Sanofi or other companies?

It probably won’t come as a surprise to read:

The AF Exchange Group is supported by an unrestricted educational grant from Sanofi-aventis.

If this was an “unrestricted educational grant,” who provided oversight? Was there anyone involved who was not paid by Sanofi?

In addition to being the first author of the paper, Prystowsky is the editor-in-chief of the journal. A note attached to the paper states: “This article was processed by a guest editor.” What does “processed” mean? Who was the guest editor? How was the guest editor chosen? What freedom or independence did the guest editor have? Was the article peer-reviewed?

All the authors appear to have received financial support from Sanofi. (I’ve reproduced the lengthy COI disclosure statement at the bottom of this post.)

Here’s the text of the acknowledgment at the end of the paper:

This article, which has been written and reviewed by the
AF Exchange faculty, is based on independent discussion and opinion that
occurred at a CME-accredited meeting. The AF Exchange Group would like
to thank Dr. Felicity Leigh for her editorial support (consolidating author
amends, formatting, styling) in the preparation of this article.

What are the details of the CME-accredited meeting? What organization provided the accreditation? What exactly did Dr. Felicity Leigh do?  A quick search on the internet reveals that Leigh is an employee of Adelphi, a large company providing “lifecycle solutions in healthcare.” Why is Leigh’s affiliation not disclosed? Has Leigh ever served as a ghost writer for Adelphi or other companies? Is Adelphi a client of Sanofi? What role did Adelphi play in organizing the AF Exchange Group and/or the publication of this paper? Who actually wrote the paper?

Why is this paper published in the main part of the journal and not as a supplement? I’m no big fan of supplements, but at the very least with a supplement everyone understands that there is commercial support. The presence of this paper in the journal itself suggests a degree of independence free of all commercial support that does not appear to be true.

Here’s another series of questions raised by the source who sent the paper to me:

“Should the editor of a journal use his or her bully pulpit to promote a drug or device? If they do, should they participate in it or lead it? Is that the proper role of an editor? Should such pronouncements fall within the purview of a journal or the professional societies? Should they be sponsored by drug or device companies? Where do you draw the line between editorial independence and commercial considerations? Who has the oversight? Shouldn’t there be a firewall?”

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)
• More pieces of the Multaq puzzle (April 8 )

Here is the full COI disclosure statement taken from the article:

E. Prystowsky reports participation in a new antiarrhythmic drug study supported by Sanofi-aventis and consultancy for the same; he consults for Boehringer-Ingelheim; he has received honoraria relevant to this topic. J. Cammreports participation inmulticenter trials supported by Daiichi, Pfizer, BMS, Cardiome, and Merck; he received compensation for participation on a speaker’s bureau from Sanofi-aventis, Cardiome, Merck, and Astellas; he serves as a consultant or on the advisory boards of Merck, Sanofi-aventis, Boehringer-Ingelheim, Daiichi, and Medtronic. G. Lip reports participation in research studies supported by Astellas, Astra Zeneca, Biotronic, Cardiome; he serves as a consultant or on the advisory boards of Bayer,Astellas, Astra Zeneca, Sanofi-aventis, Biotronic, Cardiome, Boehringer-Ingelheim. M. Allessie reports compensation on a speakers bureau, but did not name the sponsor. J.-F. Bergmann reports honoraria from Sanofi-aventis and Glaxo Smith Kline; he serves as a consultant or on the advisory board of Sanofiaventis. G. Breithardt reports participation in research grants supported by St. Jude Medical and Sanofi-aventis; he received compensation for participation on a speakers bureau from Sanofi-aventis, Boehringer-Ingelheim, Bayer, Biotronic, and Guidant; he serves as a consultant or on the advisory boards of Sanofi-aventis, Biotronic, Boehringer-Ingelheim, and Bayer. J. Brugada reports participation on the RELY research grant; he received honoraria and travel support, but did not name the sponsor. H. Crijns reports participation on a research grant supported by Sanofiaventis, as well as participation on a speakers bureau and serving as a consultant or on the advisory board of that company. P. Ellinor reports participation on multiple research grants, including CHS, FHS, Rotterdam, MONICA/KORA, and PREVENT-IT studies; he serves as a consultant or on the advisory boards of Sanofi-aventis and Ortho-MacNeil. D. Mark reports participation on research grants supported by Alexion Pharmaceuticals, Eli Lilly, Proctor & Gamble, Pfizer, Medtronic, Medicure, Innocoll, and St. Jude Medical; he serves as a consultant or on the advisory board ofSanofi-aventis. G. Naccarelli reports participation on research grants supported by Glaxo Smith Kline, Boehringer-Ingelheim, Boston Scientific, and Sanofi-aventis; he has received consultant fees or honoraria from Sanofiaventis, St. Jude Medical, Bristol Myers Squibb, Merck, Portola, Otsuka, Boehringer-Ingelheim, Pfizer, Astra Zeneca, Medtronic, Gilead, Cardiome, Novartis, Xention, Astellas, Glaxo Smith Kline, and Biocritique. D. Packer reports participation on research grants supported by St. Jude Medical, Biosense Webster, Boston Scientific, Medtronic, Cryocath, and Siemens USA; he serves as a consultant or on the advisory boards of Medtronic, St. Jude Medical, Siemans, Sanofi-aventis, BiosenseWebster, and Cryocath; he reports a patent on mapping technology. J. Tamargo reports speakers bureau fees and honoraria, as well as serving as a consultant or on advisory board, but does not name the sponsors/companies. Address for correspondence: Eric N. Prystowsky,M.D., c/o The CareGroup, 8333 Naab Road, Suite 400, Indianapolis IN 46260, USA. Fax:+1-317-338- 6246; E-mail: eprystow@TheCareGroup.com; eprymd@aol.com Manuscript received 18 January 2010; Revised manuscript received 18 January 2010; Accepted for publication 8 February 2010. doi: 10.1111/j.1540-8167.2010.01770.x