Correspondence
Authors' Conflicts of Interest: A Disclosure and Editors' Reply
N Engl J Med 1999; 341:1618-1619November 18, 1999
- Article
To the Editor:
My recent article in the Journal (Sept. 23 issue)1 has received some attention from the media, and I would like to clarify the facts.
In February 1998, Dr. Alastair Wood, editor of the Journal 's Drug Therapy series, invited me to submit a review article on the treatment of hair loss. He asked me to inform him of any equity interest I held in companies whose products would be discussed in the article and any consultancies or other financial support I had from such companies. I responded in writing to Dr. Wood that I was a consultant to two pharmaceutical companies whose products would be mentioned in the article (Merck and Company and Pharmacia & Upjohn), that I had no equity interest in either company, that I had never been an employee of either company, and that I would terminate my consultancy agreements with them immediately. At no time did I have a retainer from either company, and I was compensated on a per diem basis only.
In answer to Dr. Wood's question about financial support, I responded that I was an investigator in multicenter, double-blind clinical trials of finasteride for androgenetic alopecia and of topical minoxidil solution for androgenetic alopecia and alopecia areata, and that funds for conducting these trials were provided by the pharmaceutical companies to the University of California. I was told that this support did not disqualify me from writing the article.
Dr. Wood asked me to inform him if any outside person or organization was to be involved in the preparation of the manuscript. I was the only person involved in the preparation of the manuscript and, except for the reviewers chosen by the Journal, no one saw the manuscript before publication.
When I was invited to write the review article in February 1998, 1-mg finasteride and 5 percent topical minoxidil solution had been available as drugs approved by the Food and Drug Administration for approximately one month. At that time, in my view, the clinical investigators who conducted the double-blind trials and therefore had first-hand knowledge of the efficacy, limits, and side effects of the two drugs were those who could best write about them.
1 ReferencesVera H. Price, M.D.
University of California, San Francisco, San Francisco, CA 941171
Price VH . Treatment of hair loss. N Engl J Med 1999;341:964-973
Full Text | Web of Science | Medline
Author/Editor Response
Editors' reply:
The Journal 's conflict-of-interest policy prohibits authors of editorials and review articles from having “current, recent past, or planned future financial associations (such as equity interest, consultancies, or major research support) with a company that stands to gain from the use of a product (or its competitor) discussed in the editorial or review article.” At the time Dr. Price was asked to write her review article, she was consulting for Merck and Upjohn and received the majority of her research support from them.
The discrepancy between policy and practice in this case was not the fault of Dr. Price. As she explains, she informed Dr. Wood, the editor of our Drug Therapy series, whose office is in Nashville, of her consultancies with Merck and Upjohn and of her research support from them. Dr. Wood assured Dr. Price that it would be permissible for her to write a review article for the Journal if she discontinued her consultancy arrangements, and they exchanged letters to that effect. Those letters were reviewed in our Boston office, and we did not question them — which, to conform with our written policy, we should have done.
As for research support, Dr. Wood has not routinely considered support from companies that is given through researchers' institutions to constitute a conflict of interest, nor has he routinely tried to distinguish between major and minor research support. In this case, he ascertained that Dr. Price had research support from Merck and Upjohn given through her institution.
Dr. Price signed our standard form attesting that she had no major financial associations with relevant companies, but she understandably assumed that her assurances from Dr. Wood took precedence.
In view of the differences between our stated policy and the way it has been interpreted with respect to Drug Therapy articles, both in Nashville and in Boston, we are now looking into the possibility that authors of other published articles in this series may have had financial associations with pharmaceutical companies that were incompatible with our stated policy. We will disclose the facts when we have reviewed them. In addition, it is possible that authors of Drug Therapy articles in preparation may have major research support from relevant companies or recent consultancy arrangements. Since it would be unfair to reject those articles after their authors acted in good faith, we will simply disclose such support at the time of publication.
Authors of newly solicited and all future review articles will be held strictly to our stated policy. We will continue to decide whether research support is major on a case-by-case basis. Minor research support will not preclude authorship but will be disclosed to readers at the time of publication.
Our conflict-of-interest policy for editorials and review articles is the most stringent of any medical journal, and it is stricter than our policy for original research articles, which requires only disclosure. For reasons made clear in earlier editorials,1-3 we believe it is important that authors of editorials and review articles have no significant financial associations with companies that make products they discuss in those articles. It is a difficult policy to maintain, because of the increasing connections between clinical researchers and the companies that make the products they study. Nevertheless, it is our intention to continue the policy and to redouble our efforts to bring our practice into conformity with it.
We regret the recent confusion about this matter and apologize to Dr. Price for any difficulty it has caused her.
3 ReferencesMarcia Angell, M.D.
Alastair J.J. Wood, M.D.1
Relman AS . New “Information for Authors“ -- and readers. N Engl J Med 1990;323:56-56
Full Text | Web of Science | Medline2
Kassirer JP ,Angell M . Financial conflicts of interest in biomedical research. N Engl J Med 1993;329:570-571
Full Text | Web of Science | Medline3
Angell M ,Kassirer JP . Editorials and conflicts of interest. N Engl J Med 1996;335:1055-1065
Full Text | Web of Science | Medline
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1
Graziano Riccioni, Nicola Vitulano, Nicolantonio D’Orazio. (2009) Ivabradine: Beyond heart rate control. Advances in Therapy 26:1, 12-24
CrossRef2
Drazen, Jeffrey M., Curfman, Gregory D., . (2002) Financial Associations of Authors. New England Journal of Medicine 346:24, 1901-1902
Full Text3
Anna Garc
a-Alt
CrossRef4
McCrary, S. Van, Anderson, Cheryl B., Jakovljevic, Jelena, Khan, Tonya, McCullough, Laurence B., Wray, Nelda P., Brody, Baruch A., . (2000) A National Survey of Policies on Disclosure of Conflicts of Interest in Biomedical Research. New England Journal of Medicine 343:22, 1621-1626
Full Text5
Angell, Marcia, Utiger, Robert D., Wood, Alastair J.J., . (2000) Disclosure of Authors' Conflicts of Interest: A Follow-up. New England Journal of Medicine 342:8, 586-587
Full Text
- Letters
