Good Reasons Why Physicians Should Not “Believe the Data”

by Donald W. Light

In September, The New England Journal of Medicine published an important study funded by the Edmond J. Safra Center for Ethics that measured the loss of trust in medical science as an institution that should be dedicated to trustworthy research for treatments that restore or maintain patients’ health. 

Specifically, 503 board-certified internists were shown abstracts of hypothetical clinical trials allegedly funded by industry or by the NIH. Respondents said they distrusted reports of trials funded by pharmaceutical companies significantly more than those funded by NIH, even if well-designed.1 They “were half as willing to prescribe drugs” tested by industry.

This study highlights the depth of distrust that has arisen from years of evidence that researchers and authors, who must constantly raise funds for their work from the pharmaceutical industry, have repeatedly run biased clinical trials, then slanted the analysis of trial data in favor of the sponsor’s drug, and then further biased how the results are written up in what becomes published medical science. Several current or recent fellows at the Center are studying institutional corruption in pharmaceuticals, including Pavel Atanasov, Lisa Cosgrove, Carl Elliott, Marc-Andre Gagnon, Adriane Gelpi, Alison Hwong, myself, Jonathan Marks, Jennifer Miller, Genevieve Pham-Kanter, Marc Rodwin, Susannah Rose (a co-author of the NEJM article), Mildred Schwartz, Sergio Sismondo, and Robert Whitaker.   

Dependency corruption arises when an institution such as medicine, which is dedicated to getting and keeping patients as healthy as possible, has its mission corrupted or distorted by those involved having to seek funds from companies primarily dedicated to maximizing profits for shareholders and executives.2 Researchers dependent on corporations eager for drug approval and widespread use have distorted both the trials and their write-up in abstracts and journal articles. These become the medical knowledge that doctors use to prescribe, certified as trustworthy by reviewers and editors of top medical journals. Thus the corruption of medical science has come to threaten the trustworthiness of top journals, and editors have fought back for over a decade to minimize the opportunities for biased articles and the distrust it has engendered. Such distrust is hard to overcome, except by structural changes that remove dependency corruption itself.

In response to the article, Jeffrey Drazen, the Editor-in-Chief of The New England Journal of Medicine, wrote an editorial to urge that physician readers “Believe the Data.”3 The issue never was the data, which physicians and even most reviewers never see, but the ways in the data gets written up in biased articles that get through reviewers and editors to be published in top journals.

Drazen starts by expressing concern about the general distrust found by the study, because new drug development so greatly relies on industry funding and the altruism of patient participants. He claims that “this lack of trust” depends on negative press stories and cites five that were about other manifestations of institutional corruption, such as concealing trial results, trying to suppress unfavorable publication, and misleading promotion of drugs. Ironically, Drazen concludes with examples of ways in which The New England Journal of Medicine is continuing its multi-year efforts to protect its scientific integrity and trustworthiness from incomplete or biased research articles.  

In response to this editorial, I wrote the following short letter, now published, that could cite only a few of the many systematic studies documenting good reasons for distrusting articles by industry-sponsored authors in medical journals. As concerned physicians have said, medical knowledge and medical science have become corrupted in ways that take years to find out and correct, if ever. Here is the letter:

“Dr. Drazen’s editorial,3 invoking physicians to believe articles based on well-designed trials that are company-sponsored, misrepresents the source of physicians’ distrust as “press coverage of a few examples… ” Systematic studies show that such articles are three to four times more likely to favor a company’s product than independently sponsored articles.4,5 The editorial also equates NIH researchers’ interests in promotion and recognition to the interests of multi-billion dollar corporations that shape trial design, execution, data collection, coding, statistical analysis, decisions about which negative results or trials not to include, analysis in an article, abstract,  and conclusions, often ghost-managed by one of the 182  publication-planning companies that shape, edit, and write articles for top medical journals.5, 6, 7 Unfortunately, studies of sponsorship support physicians’ distrust of published articles based on trial data of drugs.”


Donald W. Light, Ph.D.
Lab Fellow, Edmond J. Safra Center for Ethics, Harvard University 2012-2013
Professor of Comparative Health Policy, UMDNJ
dlight@ethics.harvard.edu   609-216-0071


References

1.    Kesselheim AS, Robertson C, Meyers J, et al. "A Randomized Study of How Physicians Interpret Research Funding Disclosures." New England Journal of Medicine 2012;367:1119-27.
2.    Lessig L. Republic, Lost: How Money Corrupts Congress - and a Plan to Stop It. New York: Twelve/Hachette; 2011.
3.    Drazen J. "Believe the Data." New England Journal of Medicine 2012;367:1152-53.
4.    Lexchin J, Bero LA, Djulbegovic B, Clark O. "Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review." BMJ 2003;326:1167-70.
5.    Schott G, Henry P, Limbach U, Gundert-Remy U, Ludwig W-D, Lieb K. "The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences, Parts 1 & 2." Deutsches Ärzteblatt International 2010;107:279-301.
6.    Sismondo S, Nicholson S. "Publication Planning 101: A Report." Journal of Pharmacy and Pharmaceutical Science 2009;12:273-79.
7.    Rising K, Bacchetti P, Bero L. "Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation." PLoS Medicine 2008 (Nov);5:e217.