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Incomplete Financial Disclosure for Study of Funding and Outcomes in Major Cardiovascular TrialsIncomplete Financial Disclosure for Study of Funding and Outcomes in Major Cardiovascular Trials

JAMA. 2006;295(23):2725-2726. doi:10.1001/jama.295.23.2725-b
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AUTHOR INFORMATION

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

INCOMPLETE FINANCIAL DISCLOSURE FOR STUDY OF FUNDING AND OUTCOMES IN MAJOR CARDIOVASCULAR TRIALS

To the Editor: I would like to apologize to the readers of JAMA for an incomplete financial disclosure in my article on reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations.1 My coauthor and I received no financial or material support of any kind from any entity for this study. In the article, we described the funding source and outcome for those cardiovascular trials surveyed in which I served as either the primary author or coauthor.2 5

However, JAMA policy requires disclosure of any potential conflicts of interest even when there is no funding for the study at hand. This policy does not distinguish whether or not the conclusions are unfavorable to the entities involved. In this regard, over the past 5 years I have received research funding from multiple not-for-profit entities including the National Heart, Lung, and Blood Institute, the Doris Duke Charitable Foundation, the Leducq Foundation, the Donald W. Reynolds Foundation, the American Heart Association, and the James and Polly Annenberg La Vea Charitable Trusts. I have also received investigator-initiated research support during this 5-year period from multiple for-profit entities including AstraZeneca, Bayer, Bristol-Myers Squibb, Dade-Behring, Novartis, Pharmacia, Roche, Sanofi/Aventis, and Variagenics. I am also listed as a coinventor on patents held by the Brigham and Women's Hospital that relate to the use of inflammatory biomarkers in cardiovascular disease and have served as a consultant to several of the above-listed entities. None of these entities played any role whatsoever in the design, interpretation, or drafting of the manuscript.1 I regret making this omission.

Financial Disclosures: Dr Ridker reports that he has received research funding and research support from the National Heart, Lung, and Blood Institute, the Doris Duke Charitable Foundation, the Leducq Foundation, the Donald W. Reynolds Foundation, the American Heart Association, the James and Polly Annenberg La Vea Charitable Trusts, AstraZeneca, Bayer, Bristol-Myers Squibb, Dade-Behring, Novartis, Pharmacia, Roche, Sanofi/Aventis, and Variagenics. Dr Ridker reports being listed as a coinventor on patents held by the Brigham and Women's Hospital that relate to the use of inflammatory biomarkers in cardiovascular disease and has served as a consultant to Schering-Plough, Sanofi/Aventis, AstraZeneca, Isis Pharmaceuticals, Dade-Behring, and Interleukin Genetics.

References
Ridker PM, Torres J. Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005.  JAMA. 2006;2952270-2274
PubMed
Albert MA, Danielson E, Rifai N, Ridker PM. Effect of statin therapy on C-reactive protein levels: the Pravastatin Inflammation/CRP Evaluation (PRINCE): a randomized trial and cohort study.  JAMA. 2001;28664-70
PubMed
Ridker PM, Goldhaber SZ, Danielson E.  et al.  Long-term, low-intensity warfarin therapy for prevention of recurrent venous thromboembolism.  N Engl J Med. 2003;3481425-1434
PubMed
Ridker PM, Cook NR, Lee I-M.  et al.  A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women.  N Engl J Med. 2005;3521293-1304
PubMed
Lee I-M, Cook NR, Gaziano JM.  et al.  Vitamin E in the primary prevention of cardiovascular disease and cancer: the Women's Health Study: a randomized controlled trial.  JAMA. 2005;29456-65
PubMed

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Ridker PM, Torres J. Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005.  JAMA. 2006;2952270-2274
PubMed
Albert MA, Danielson E, Rifai N, Ridker PM. Effect of statin therapy on C-reactive protein levels: the Pravastatin Inflammation/CRP Evaluation (PRINCE): a randomized trial and cohort study.  JAMA. 2001;28664-70
PubMed
Ridker PM, Goldhaber SZ, Danielson E.  et al.  Long-term, low-intensity warfarin therapy for prevention of recurrent venous thromboembolism.  N Engl J Med. 2003;3481425-1434
PubMed
Ridker PM, Cook NR, Lee I-M.  et al.  A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women.  N Engl J Med. 2005;3521293-1304
PubMed
Lee I-M, Cook NR, Gaziano JM.  et al.  Vitamin E in the primary prevention of cardiovascular disease and cancer: the Women's Health Study: a randomized controlled trial.  JAMA. 2005;29456-65
PubMed
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