- The Washington Times - Monday, March 6, 2000

The editors at the New England Journal of Medicine cried mea culpa last month, asking our forgiveness for what top editor Dr. Marcia Angell enigmatically referred to as "the most serious mistake for which we have had to apologize."
The transgression? The editors claimed they had violated their own publication's policy 19 times over the past three years by permitting researchers with potential financial conflicts of interest to author review articles on the safety and efficacy of pharmaceuticals.
Ostensibly this apology and reaffirmation of standards was meant to keep science free of bias and improve the quality and credibility of the research published in one of the nation's most prestigious medical journals. Unfortunately, however, this "confession" only highlighted an ill-advised policy that consigns research to being judged not on its scientific merits, but rather on whether a purported conflict of interest contaminated the quality of the work.
The Journal's policy requires it to select for its pharmaceutical review columns only authors who have no recent history of research grants, consultant fees or any other financial exchange with companies that manufacture the drugs being reviewed. The policy applies not only to funding of the researcher in question (here the Journal adhered to its policy) but also to funding to the institution that employs the author (this was not enforced, and was the focus of the apology). Thus, the Journal is chastising itself for failing to disqualify an author whose department or medical school as opposed to the researcher himself had at some point accepted corporate research money. In fact, requiring such financial disclosure does not promote good science nor does it serve to eliminate all or most sources of bias.
First, there is the question of financial conflict of interest at the New England Journal of Medicine itself. The vast majority of the institution's estimated $20 million annual budget comes from pharmaceutical company advertisements. How in good faith can the editors disqualify authors on the basis of financial ties when they themselves have their salaries paid by the same companies?
Second, the term "conflict of interest" encompasses far more than the potential bias linked to corporate-sponsored research. If Researcher A is required to dis- close that he has consulted for Pfizer, and is thus disqualified as an author, why should Researcher B, whose stock portfolio may be 80 percent Pfizer be considered unbiased and acceptable? Is the next step in author disclosure going to be a tell-all of personal and family members' investment portfolios?
Where does the attempted exorcism of conflict of interest for researchers stop? And why is its scope restricted to financially driven bias? In a 1993 commentary entitled "Conflict of Interest: The New McCarthyism in Science" published in the Journal of the American Medical Association, Dr. Kenneth Rothman presented a stinging critique of the financial disclosure requirements of scientific journals, noting that many potential biases other than financial ones abound.
Should authors who write about homosexuality and AIDS be required to reveal their sexual preference? Should researchers assessing the health benefits and risks of alcohol be required to divulge if they are Mormons? Should researchers funded by ideologically fueled foundations hostile to profit-making enterprises of all kinds be considered suitable as authors for assessing the value of pharmaceuticals? As Dr. Rothman noted, "Like McCarthyism in the l950s, this frenzy of credential checking is apt to get way out of hand."
Policies that exclude as authors any and all who have even the remotest form of funding from industry leave a highly self- selected group of potential authors remaining in the pool. Perhaps those who remain eligible because they had no financial ties with drug companies were not selected as consultants because of an inferior academic record. Or perhaps because they had obvious antipathy to what they view as "obscene profits" of the pharmaceutical industry. Are these scientists free of conflict of interest?
What is ultimately most insulting and demeaning about the so-called conflict of interest rules of financial disclosure is (a) they, at least subtly, discredit the purged authors without giving them a chance at self-defense and (b) they disparage the integrity of the time-honored scientific peer review process where a work is submitted to a panel of peers who judge the submission, usually anonymously, not by its funding, but by its merits. (Should the peer reviewers also be screened for possible financial ties?) Further, as Dr. Rothman noted, "judging someone's work by the funding source, or by any other characteristic other than the content, raises an ethical problem… . [a problem] similar in principle to the discredited practice of judging college applicants by their photographs."
If medical research is funded by Merck or Lily or Zeneca and is approved in an independent peer review process at the New England Journal of Medicine or any other such journal, why should it matter to the reader who funded it or what the relationship is between the author or the author's institution and the companies?
Bias stems from many sources other than financial ties, including being academically wed to a research hypothesis after years of commitment to it. The integrity of science relies on the rigors of the scientific process. The quixotic purge of corporate-funded research is no substitute for scientific scrutiny. If only it were that easy.

Dr. Elizabeth M. Whelan is president of the American Council on Science and Health.



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