Coming clean: A major figure in cardiology publishes a lengthy conflict of interest correction in JAMA
Authors’ financial disclosures can be a thorny issue for scientific journals. There’s often confusion over just what should be listed as a conflict of interest, and when relationships are revealed after papers are published, lack of disclosure sometimes leads to corrections.
For example, the Journal of Cell Science recently published this:
CRSBP-1/LYVE-1 ligands disrupt lymphatic intercellular adhesion by inducing tyrosine phosphorylation and internalization of VE-cadherin
There was an error published in J. Cell Sci. 124, 1231-1244.
Jun San Huang and Shuan Shian Huang had an equity position in Auxagen Inc. during the time the research was carried out and should have declared that there is a conflict of interest.
Part of the research described in the article was supported by NIH grants awarded to St Louis University (AA 019233 to J.S.H.) and to Auxagen Inc. (HL 087463-01 and DK 078438 to J.S.H.).
The authors apologise for this omission.
The rules can sometimes trip up even the most prominent figures in medicine, it turns out. This week’s Journal of the American Medical Association (JAMA) includes this lengthy letter from Eugene Braunwald, whose 1000-plus publications and textbook tower over the field of cardiology:
It has been brought to my attention that there were differences in my financial disclosures in a number of articles recently published in JAMA, and this warrants explanation.
The original research report by Preiss et al1 dealt with statins, and in that article I reported that the TIMI Study Group in which I work has received research support through the Brigham and Women’s Hospital from Merck, Astra-Zeneca, and Pfizer, each of which manufactures and sells a statin.
In a Commentary on the role of digoxin,2 Dr Gheorghiade and I mention and comment on a wide variety of drugs used in the treatment of heart failure (beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, aldosterone-blocking agents). Because 1 or moreof these agents are manufactured by virtually every pharmaceutical company, I listed all with which I had any connectionat that time.
A more recent Commentary was quite general.3 It focused on a pathophysiological approach for assessing patients with heart failure. The drugs mentioned are generic—nitroglycerin, dobutamine, and esmolol—and I did not perceive a possible conflict of interest. In a recent Editorial on reductions in heart failure hospitalizations, 4 Dr Gheorghiade and I mention eplerenone and tolvaptan. The former is manufactured by Pfizer, from which we no longer receive any support. The latter is manufactured by Otsuka, with which I have had no contact. Again, I did not perceive any conflict of interest.
However, the relationships present during the 36 months prior to submission of the latter 2 articles include research support from Merck, AstraZeneca, Johnson & Johnson, Beckman Coulter, Eli Lilly, Roche Diagnostics, sanofiaventis, Daiichi Sankyo, GlaxoSmithKline, Bristol-Myers Squibb, and Pfizer as well as participation in symposia, advisory board meetings, and/or consultancies for the following companies: Eli Lilly, Merck, Genzyme, Amorcyte, CVRx (no compensation), The Medicines Company, CV Therapeutics, Daiichi Sankyo, MC Communications, Ortho McNeil, Ikaria, Menarini International, CardioRentis, and sanofi-aventis.
These were not listed because I did not consider them to be relevant to these 2 articles. I did not understand that all financial interests, regardless of their perceived relevance, had to be disclosed. I now understand the requirements for financial disclosure.
I hope that this clears up any possible misunderstanding.
The fact that Braunwald’s disclosures required corrections is perhaps a good indication that even people who’ve thought about this issue a lot can still get lost. Braunwald, after all, chaired a committee that recommended limiting doctors’ outside income at Harvard teaching hospitals. The JAMA editors write that the lack of disclosure wasn’t all due to Braunwald’s confusion:
We appreciate Dr Braunwald providing his professional and transparent explanation to clarify the differences in the reported financial disclosures among several of his recent publications in JAMA.We fully recognize that determining relevant financial relationships involves judgment and that reporting of financial disclosure information certainly is not an exact science. In fact, in one of the Commentaries1 that Dr Braunwald mentions, his coauthor, Dr Gheorghiade, had reported to JAMA that he had received consulting fees from Bayer, Novartis, Sigma Tau, Johnson&Johnson, Takeda, Otsuka, and Medtronic. However, these disclosures inadvertently were omitted from the published article. The editors apologize for this oversight and regret this error. We urge all authors to fully disclose all possible conflicts of interest as recommended by the International Committee of Medical Journal Editors. A correction regarding the clarification of conflict of interest disclosures for Drs Braunwald and Gheorghiade appears in this issue.
For reference, here is the meat of JAMA’s conflict of interest policy:
Conflicts of Interest and Financial Disclosures. A conflict of interest may exist when an author (or the author’s institution or employer) has financial or personal relationships or affiliations that could influence (or bias) the author’s decisions, work, or manuscript. All authors are required to complete and submit the ICMJE Form for Disclosure of Potential Conflicts of Interest. In this form, authors will disclose all potential conflicts of interest, including relevant financial interests, activities, relationships, and affiliations (other than those affiliations listed in the title page of the manuscript), including
- Any potential conflicts of interest “involving the work under consideration for publication” (during the time involving the work, from initial conception and planning to present),
- Any “relevant financial activities outside the submitted work” (over the 3 years prior to submission), and
- Any “other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing” what is written in the submitted work (based on all relationships that were present during the 3 years prior to submission).5
Of potential interest to Retraction Watch readers is that Braunwald was involved in what was likely the largest number of retractions by a single author before Joachim Boldt. John Darsee retracted some 82 papers, 30 of which were published while he was at Harvard working with Braunwald.