Some key quotes:
There can be no doubt that editors of peer-reviewed medical journals must always place the interest of patients above all else. Every published article eventually can and should affect patient care. Therefore, all articles that we publish must be ethically sound, valid, reliable, and credible (ie, reflective of work that is performed, written, reviewed, and edited in a manner that is unencumbered by financial pressure). With that in mind, it is important to discern the necessary and honest interests of for-profit companies from the potentially corrupting influence of commercial interests.Most remarkable about this editorial was that in it Dr DeAngelis singled out the Harvard Medical School.
In some instances, the marketing goal of a company dominates the scientific aspect of the company-funded research. There have been a number of high-profile examples of such research irregularities involving for-profit companies, such as the refusal to provide all study data to the study team, reporting only 6 months of data in a trial designed to have 12 months of data as the primary outcome; incomplete reporting of serious adverse events; and concealing clinical trial data showing harm.
For-profit companies also can exert inappropriate influence in research via control of study data and statistical analysis, ghostwriting, managing all or most aspects of manuscript preparation, and dictating to investigators the journals to which they should submit their manuscripts.
How do editors preserve the integrity of their journals while ensuring that they serve as vehicles for dissemination of scientific information that could help clinicians provide better care for their patients? First and foremost is to ensure that all published articles are scientifically sound and as objective and unbiased as possible by using rigorous peer review and careful editorial evaluation. Another important aspect is to ensure that readers are aware of the authors' financial relationships and potential conflicts of interest so that these readers can interpret the article in light of that information.
Because we are so adamant and open about disclosure of financial interests, it is not surprising that we are being made aware of nondisclosures by authors and by readers. Somewhat surprising was that 3 consecutive cases of nondisclosures, all of which raised the interest of the mainstream press, involved authors from Harvard Medical School. To his credit, the dean of Harvard Medical School has informed me of his plan to send a letter enclosing the disclosure requirements for JAMA (plus our July 12, 2006, editorial) and those for the New England Journal of Medicine to all 8000 Harvard Medical School faculty members. In addition, he indicated that he will work with his faculty to enhance Harvard Medical School's current policies on financial relationships with for-profit companies (Joseph B. Martin, MD, PhD, oral communication, July 18, 2006).A news article in the Boston Globe actually reported that Dr DeAngelis called Dr Martin and said, "Joe, do something with your kids." "Kids" here refers to the distinguished faculty of the Harvard Medical School.
In my humble opinion, it's good that some of the pervasive conflicts of interest in health care are starting to get more public scrutiny. Although disclosure of conflicts of interest do not negate all the problems they cause, full disclosure would at least make all aware of the scope of the problem
That's where the irony comes into this story. Dr Martin, in addition to his day job at Harvard, is a member of the board of directors of Baxter International, which describes itself as "a global healthcare company that, through its subsidiaries assists healthcare professionals and their patients with treatment of complex medical conditions including hemophilia, immune disorders, kidney disease, cancer, trauma and other conditions." Dr Martin is also a member of the board of directors of Cytyc, which makes a variety of diagnostic and therapeutic devices for use in gynecology. Dr Martin's official Harvard on-line biography does not mention these affiliations. Dr Martin did report these affiliations when writing, for example, an article for the New England Journal of Medicine about academic collaboration with industry (Moses H, Braunwald E, Martin JB, Their SO. Collaborating with industry — choices for the academic medical center. N Engl J Med 2002; 347(17):1371-5.) How Dr Martin simultaneously manages his fiduciary responsibilities to maximize financial results for the stock holders of Baxter International and of Cytyc and his leadership responsibilities at the Harvard Medical School is not clear.
So it would seem that full disclosure about conflicts of interest in health care really should begin at home.
Post Title → Disclosing Conflicts of Interest: A Story Involving JAMA, Harvard Medical School, Baxter International, Cytyc
