The JAMA versus Jonathan Leo debacle worsens, should Catherine DeAngelis apologize?

In: Daily Health Scope

24 Mar 2009

1 Response to The JAMA versus Jonathan Leo debacle worsens, should Catherine DeAngelis apologize?

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David K. Cundiff, MD

May 14th, 2009 at 3:44 pm

Re: Undisclosed financial conflicts of 31 researchers publishing in JAMA, NEJM, and Arch. Int. Med.

Since you wrote about the case of Dr. Jonathan Leo and Dr. Catherine DeAngelis of JAMA, I thought you might be interested in more conflict of interest cases involving medical journal authors and journal editors unwilling to expose them.
I detailed the evidence for undisclosed financial conflicts by 31 anticoagulation researchers to

• Dr. Catherine DeAngelis, Chief Editor of JAMA
• Dr. Jeffrey Drazen, Chief Editor of New England Journal of Medicine
• Dr. Rita Redberg, Chief Editor of the Archives of Internal Medicine.

They refused to publicly disclose these conflicts. At issue is whether payments from anticoagulant-producing drug companies to authors for drafting the American College of Chest Physician (ACCP) guidelines for anticoagulant and thrombolytic drug use should be disclosed in articles concerning anticoagulant and thrombolytic drugs published in other medical journals.

Background

DuPont Pharmaceuticals funded development of the first six antithrombotic and thrombolytic therapy guidelines publications (1986 – 2001). DuPont produced Coumadin until 2001 when it was sold to Bristol-Myers Squibb. Subsequently, a coalition of antithrombotic drug producing companies has acknowledged their sponsorship of the ACCP guidelines as follows:

• The American College of Chest Physicians wishes to acknowledge the cooperation and support of the following sponsors for providing an unrestricted educational grant to support the publication of this supplement to CHEST: AstraZeneca LP; Aventis Pharmaceuticals; Bristol-Myers Squibb/Sanofi-Syntholabo Partnership; GlaxoSmithKline; Organon Sanofi-Synthelabo LLC (2004)
• “The American College of Chest Physicians wishes to acknowledge the cooperation and support of the following sponsors for providing an unrestricted educational grant to support the publication of this supplement to CHEST: AstraZeneca LP; Aventis Pharmaceuticals; Bristol-Myers Squibb/Sanofi-Syntholabo Partnership; GlaxoSmithKline; Organon Sanofi-Synthelabo LLC” (2008)

The pharmaceutical companies directly financially supported the anticoagulant and thrombolytic drug guideline authors in the following ways:

1. Travel to and from the conferences
2. Hotel accommodations
3. Meals
4. Payments for guideline authorships

Indirect forms of compensation to 62 of the 93 guideline authors of the 2004 guidelines included the following:

1. Speakers’ bureau participation fees
2. Consultantships
3. Research grants
4. Financial support of faculty positions (e.g., research scholars program of the Heart and Stroke Foundation of Canada funded in part by Pfizer Canada Inc., Sanofi-Aventis, AstraZeneca Canada, Bayer, Hoffmann-La Roche, Boehringer Ingelheim Ltd./Ltée)

The process of selecting individuals to draft the ACCP anticoagulation guidelines has not been transparent. The selection process has not been detailed in any of the eight ACCP anticoagulation guideline supplements published in CHEST. Among those not represented on the committees to draft guidelines are the following:

1. Patients receiving anticoagulants
2. Consumer groups
3. Government experts from the FDA, NIH or other agencies
4. Physicians, pharmacists, nurses, or other scientists who have not received funding in one form or another from pharmaceutical companies that make anticoagulants.

Drs. DeAngelis and Redberg say that JAMA and the Archives of Internal Medicine do not need to disclose their authors support for drafting anticoagulation guidelines because the declaration of support for the guidelines in the CHEST Supplements did not specifically say the authors received direct payments. They declined to ask Dr. Richard S. Irwin, CHEST Editor in Chief, or Dr. Jack Hirsh, Chair ACCP Anticoagulation and Thrombolysis Practice Guidelines, about funds going to pay guideline authors. NEJM editor Dr. Drazen said, “If an author has received payments for work on guidelines from an official organization, such as an established professional society, that sponsored the guidelines, disclosure is not required.”

Anticoagulant and thrombolytic drugs cause tens of thousands of bleeding deaths per year in the USA alone. If you are interested, I can send details of the anticoagulation authors and their articles.
Thank you.
Sincerely,
David K. Cundiff, MD

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