Editorial
Financial Conflicts of Interest in Biomedical Research
N Engl J Med 1993; 329:570-571August 19, 1993
- Article
Financial conflicts of interest in medicine -- what they are and how to deal with them -- constitute one of the most contentious issues in our profession. Organized medicine and its critics have debated whether clinicians should gain financially from their practice in any way other than through their direct fees or salaries for service., and the academic community and its critics have debated whether medical researchers should gain financially from companies whose products they are evaluating. Opinions vary greatly -- from those advocating that all conflicts of interest be proscribed to those arguing for disclosure and caveat emptor to those maintaining that there is no problem. There are even disagreements about the definition of a conflict of interest. Many attach qualifiers, such as “potential” or “apparent,” in an attempt, it often seems, to be delicate or nonjudgmental.
In this issue of the Journal, Thompson1 provides a thoughtful and compelling analysis of the controversy. He defines a financial conflict of interest as a condition, not behavior; clinicians or researchers who might benefit financially by distorting their work have a conflict of interest regardless of whether they actually distort their work. We agree with this definition. The circumstances determine whether there is a conflict of interest, not the outcome.
Because of the increasing prevalence of commercial interests in biomedical research, the Journal in 1984 became the first of the major biomedical journals to announce a policy for dealing with financial conflicts of interest among researchers submitting manuscripts2. Arnold S. Relman, then editor-in-chief, requested that all authors disclose to us any associations they had with businesses that could be affected by their work -- including direct employment and consultancy, stock ownership, and patent-licensing arrangements. He made it clear that this information would play no part in the assessment of the report; indeed, reviewers would not even have access to it. Only at the time of publication would a decision be made about whether to disclose the information to readers. The policy also stipulated that the editors themselves could have no financial interests in any business relevant to clinical medicine; given the collegial nature of a small editorial office, it was thought insufficient for editors merely to excuse themselves from considering a particular manuscript that presented a conflict of interest. The Journal continues to differ from other journals in the breadth of its conflict-of-interest policy for editors.
In 1990 we modified the conflict-of-interest policies to apply a more stringent standard for review articles and editorials3. Unlike reports of original research, these articles represent the judgment of their authors, based on their evaluation of the literature. What studies they select to discuss and their analysis of them are necessarily subjective. Bias may be extremely difficult to detect because these articles contain no primary data to speak for themselves. For this reason, we decided not to publish review articles or editorials by authors with financial holdings in a company (or its competitor) whose product figured prominently in the article.
We have retained these policies on financial conflicts of interest. In our view, they acknowledge that conflicts of interest are now widespread and widely accepted, but they also recognize their problematic nature. As editors, we cannot simply ignore them, as Koshland recently emphasized4.
Many arguments have been raised against our policies. The most frequent are that disclosing conflicts of interest impugns the integrity of honest researchers, that prohibiting conflicts of interest in authors of review articles and editorials is a form of censorship, and that our policies unfairly ignore intellectual biases in favor of financial ones. Let's look at these arguments.
Disclosing a conflict of interest does not impugn the honesty of authors (despite the rhetoric of a recent article referring to disclosure as “McCarthyism”5). On the contrary, if problems were apparent during the peer-review process and not corrected in revision, the paper would not be published. Furthermore, the issue is not primarily one of honesty but of unconscious bias, which may be quite subtle and difficult to detect. This is one reason for disclosure; bias not appreciated in the peer-review process may still be detected by readers.
It is difficult to take the charge of censorship seriously. Freedom of the press does not imply that anyone can publish anything anywhere; it means only that government cannot prohibit the publication of certain ideas. Obviously, editors of journals set many criteria for publication; for example, we rarely publish reports of studies in animals or of research without clinical implications, regardless of their scientific validity. We nearly always solicit review articles and editorials from senior, rather than junior, investigators. Our decision to exclude authors with financial conflicts of interest is simply another criterion, designed to ensure that the articles are of maximal credibility and interest to our readers.
Our conflict-of-interest policy is directed toward financial arrangements because, as Thompson points out, they are both widespread and optional, as well as seductive. Many intellectual conflicts of interest -- for example, the desire for positive or important results in a research study -- are not optional. They are inherent to the endeavor. Fortunately, these conflicts are not hidden and they are well appreciated, since nearly all researchers share them; there is therefore no need for disclosure. Other conflicts are unusual or idiosyncratic (for example, a Seventh-Day Adventist doing research on the health effects of the sect's lifestyle), and there is no practical way of anticipating all of them or dealing with them with a blanket policy. Like Thompson, we believe that the fact that a policy cannot cover all contingencies is hardly a reason not to have one.
Financial conflicts of interest are a matter of choice. Researchers do not have to have them, nor do restrictions based on them constitute a violation of rights. In many areas of life, such restrictions are the norm. For example, judges are expected to excuse themselves from cases involving companies in which they have an interest., and no one with such an interest would be selected for a jury, no matter how much he protested his objectivity. Why should those in the biomedical research community consider it an affront to have to submit to similar restrictions? Furthermore, when researchers choose to invest in health-related companies rather than in other types of business, it raises the question of whether they are attempting to profit from the specialized knowledge they gain in the course of performing research. In other settings, this would constitute insider trading. Can this be the face we want to present to the public?
Given the current climate of clinical investigation, financial conflicts of interest will probably continue to be a fact of academic life, but they must be responsibly regulated, with disclosure being a minimal requirement. Most academic institutions and journals have not gone far enough in dealing with this problem.
Jerome P. Kassirer, M.D.
Marcia Angell, M.D.- References
References
1
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Full Text | Web of Science | Medline2
Relman AS . Dealing with conflicts of interest. N Engl J Med 1984;310:1182-1183
Full Text | Web of Science | Medline3
Relman AS . New “information for authors” -- and readers. N Engl J Med 1990;323:56-56
Full Text | Web of Science | Medline4
Koshland DE Jr . Simplicity and complexity in conflict of interest. Science 1993;261:11-11
CrossRef | Web of Science | Medline5
Rothman KJ . Conflict of interest: the new McCarthyism in science. JAMA 1993;269:2782-2784
CrossRef | Web of Science | Medline
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- Letters
