Conflict of Interest, Round 2

The editors of the Journal last commented on conflict of interest in an editorial in the April 2006 issue (1) . Two recent incidents highlight the continuing level of professional and public concern over this issue.

The first incident arose when it was discovered that some of the authors of an article published in JAMA, in which the results of an NIMH-supported study of antidepressants in pregnancy were reported, did not disclose that they had received support for other activities from pharmaceutical companies. The editors of JAMA, as well as the general media, criticized their lack of full disclosure (2) . For original research articles, as opposed to editorials and review articles, most journals have required disclosure of the funding source for the study but not disclosure of all other sources of income of each of the authors. The rationale was that the major influence on the conduct of a study comes from the funding source itself. For example, for the JAMA study, NIMH support signifies that there was independent peer review of the study design. Authors are always asked for “relevant” conflicts of interest, but perceptions of what is relevant when the study itself is funded by NIMH differ. Many people do not believe that they are influenced by pharmaceutical industry funding and therefore do not see a need for self-disclosure of other funding. However, as the reaction to the JAMA article illustrates, our credibility as a field requires complete disclosure of authors’ sources of income from the pharmaceutical and biomedical industry. The American Journal of Psychiatry now requires full disclosure of all industry-derived personal income and research funding from all authors for all articles. The disclosures will be published at the end of the article, beginning with the October issue. The article and these disclosures are reviewed by the editors for any evidence of bias as part of the decision for publication.

The second incident arose following a Wall Street Journal report that a Perspective published in Neuropsychopharmacology on vagus nerve stimulation did not fully disclose the relationship between its authors and the company that manufactures the stimulator (3) . It is precisely because editorials and review articles often recommend treatment that we outlined in our April 2006 editorial that these submissions to The American Journal of Psychiatry would have broader disclosure requirements that include all sources of support.

Disclosure has been a concern of medical journals for the past decade. Medical journals depend on the voluntary compliance of authors. Lapses, intentional and unintentional, in adherence to disclosure guidelines may occur. The New York Times, in an editorial, called for sanctions against medical authors who commit egregious lapses (4) . Journals do not have the capability to investigate and decide upon sanctions with due process for those accused of serious violations. Furthermore, multiple collaborations, which often include junior trainees, are common, and sanctions would result in the withdrawal of papers for one author’s actions that would cause harm to other careers. It has been suggested that medical schools through the American Association of Medical Colleges adopt uniform policies to deal with offenders (5) . Medical schools, which are required to regulate conflict of interest by federal funding agencies, possess the appropriate investigative committee structures. A uniform standard applied to all academic investigators would strengthen the credibility of all of medicine.

What happens beyond disclosure? Failures in disclosure are problematic because we believe that pharmaceutical and other industrial support—through speakers’ honoraria, consultation fees, and research contracts—may bias the conduct of studies, the interpretation of data, and the reporting of findings (6) . Such support may also influence the choice of treatments and other basic aspects of the practice of medicine. There is evidence that advertising promotion influences practice and that pharmaceutical companies target opinion leaders, including authors of articles in medical journals, precisely in order to influence practice (7) . The ethical concerns of medical journal publishing and of medical practice generally coincide. We do not publish articles that violate patient confidentiality because we do not violate confidentiality in the practice of medicine. We require informed consent for treatment, and so we also require it for research papers. We do not allow boundary violations in either, and we require that all interventions, whether clinical or research, have beneficial intent. Given the absence of a standard for the influence of pharmaceutical companies in our practice, it is not surprising that we do not have one for our journals. Indeed, the journals would seem to be ahead of medical practice, since most of us do not disclose to our patients the extent to which we have had interactions with the companies from whom we ask them to buy their medications (8) .

Complete separation from the pharmaceutical industry is not the answer. We cannot practice optimally without prescribing medications and without being fully informed about them. Those of us who do research intend that our findings will lead to better treatment, including better medications that pharmaceutical companies will ultimately manufacture, test, register, and market. However, new ethical standards and clearer boundaries are needed. Because we do not have a consensus among us for what constitutes good behavior, we are vulnerable to those who criticize our profession for any form of relationship with the pharmaceutical industry.

Ethical standards for the practice of medicine and for research are constantly evolving. It is timely for this evolution to include pharmaceutical company influences. One of the leaders is the Accreditation Council for Continuing Medical Education, which now has strict requirements, not only for speakers’ disclosure of conflicts of interest, but also for their independence from any influence in the preparation of their articles, slides, and talks.

Asserting control of our own education might be a first goal for us and for our professional organizations. Ethical behavior might include individual decisions by physicians to refuse marketing gifts, including trips and meals in company-sponsored educational programs. Professional societies might examine participation in speakers’ bureaus to see if it fulfills the requirements of an ethical activity for its members. Medical schools may wish to consider whether it is an appropriate activity for faculty members. The result might be that medical journals would have less conflict of interest to disclose, since fewer authors would receive income closely tied to the marketing efforts of pharmaceutical companies.

At the same time, we need to recognize the legitimacy of some activities. Consultation with the pharmaceutical industry for meaningful research and clinical purposes, not just for marketing goals, needs to continue to ensure that the enormous investment of the pharmaceutical companies in the development of new drugs is spent for the best purposes. The participation of academic researchers in clinical trials should be enhanced, not weakened, as an important source of independent judgment in the assessment of new drugs. The companies also have a legitimate role in their support of the education of physicians, both through financial support of medical education and through their marketing programs. For example, marketing through advertising in independent professional journals such as this one, where promotion material is clearly separated from the educational content, has long been considered ethical. We need to continue to define and to enforce the boundaries between promotional activities, including advertising, and the presentation of clinical and scientific information free from bias.

The public concern over the JAMA article is a reminder that anything that undermines public confidence in the medical profession also undermines public acceptance of recommended drug treatments. For psychopharmaceuticals in particular, the public’s perception that medications are prescribed by physicians free from industry influence is critical. Thus, just as we need to establish boundaries for our ethical behavior, the pharmaceutical industry needs to use its industrial organizations to set new boundaries and standards for the ethical support of physician education. We cannot allow treatment of our vulnerable patients to be compromised because of the unintended effects of overly zealous marketing.

Our previous editorial was a statement of policy for our Journal, signed by its editors. Conflict of interest has developed beyond an issue for medical journals into an issue that now affects our field as a whole. Therefore, we have sought to develop a wider, although certainly not complete, consensus, which is reflected in the expanded authorship below.