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Outrage of the Month: Editors of Prestigious Journal Sacrifice Standards to Defend an Unethical Clinical Trial

Health Letter, October 2015

Michael Carome, M.D.

Since its founding in 1812, the New England Journal of Medicine (NEJM) has established itself as one of the premier medical journals in the world. It earned that reputation through consistent adherence to the highest standards of accuracy, scientific integrity and editorial review.

Recently, however, NEJM Editor-in-Chief Jeffrey Drazen and his senior editors have shown a disturbing disregard for the journal’s traditionally high standards. This became most apparent when, in 2013, they published a series of pieces that provided a misleading and unbalanced assessment of an unethical clinical trial involving more than 1,300 premature babies.[1],[2],[3],[4],[5] Those NEJM pieces represented an ill-conceived defense of the trial, known as SUPPORT, after Public Citizen called widespread public attention (see here and here) to the U.S. Office for Human Research Protections’ (OHRP’s) March 2013 finding that parents of the infants enrolled in the trial had not been informed of the risks of the research, including risks of neurologic injury and death.

On Sept. 2, the NEJM editors sank to a new low when they published a commentary by John Lantos, a physician and bioethicist at Children’s Mercy Hospital in Kansas City, Missouri, that grossly misrepresented the meaning of the Aug. 13 order granting summary judgment for the defendants in a lawsuit related to the trial.[6] The lawsuit was brought on behalf of three children who had been enrolled in SUPPORT. The defendants included the University of Alabama at Birmingham (UAB), one of the lead institutions that conducted the trial; the trial’s principal researcher; and the head of the UAB institutional review board (IRB) that had reviewed and approved the trial’s design and consent form. The plaintiffs alleged that the babies suffered serious injuries as a result of participating in the trial.

In his commentary, Lantos claims that:

  • "Bowdre’s reasoning in dismissing the charges sheds light on the central issues in the controversy. She rejects the plaintiffs’ argument that because the infants had been in the SUPPORT study and medical problems had later developed, one should conclude that the study caused those problems."
  • The judge’s decision "appear[s] to completely vindicate the investigators and the IRB."
  • "[N]o reasonable person could conclude that being in the study caused harm."
  • "The judge’s analysis … has implications for an analysis of the OHRP’s reasoning in its critique of the SUPPORT consent forms."
  • "The summary judgement is thus a vindication of both the investigators and the U.S. system of research oversight."

Each of these claims is erroneous. The judge’s ruling was based on her finding that the plaintiffs had failed to provide sufficient evidence to establish that participation in SUPPORT probably caused their specific injuries — the legal standard under Alabama state law. The judge, however, did not find that infants in the trial were not exposed to increased risks by being enrolled in the trial. Indeed, the judge did not take a position, either way, on whether participation in the study, including the lack of informed consent, caused the plaintiffs’ injuries.

Importantly, the judge’s opinion offered no assessment, much less vindication, of the adequacy of the SUPPORT consent forms, trial design or IRB review. The judge also said nothing that would refute the OHRP’s determination that the SUPPORT consent forms failed to disclose important, reasonably foreseeable risks.

In sum, the summary judgment does not vindicate the researchers or the trial’s design and consent process.

How could the NEJM editors publish an article that was factually wrong in describing a straightforward legal ruling? My guess is that, in their zeal to claim exoneration for the SUPPORT researchers and to demand an apology from the OHRP (see the NEJM editorial[7]), the editors failed to seek expert legal review of the court’s summary judgment decision and Lantos’ commentary.

The actions of the NEJM editors are all the more egregious given that they have ready access to leading experts on health law and ethics, including George Annas, the William Fairfield Warren distinguished professor and director of the Center for Health Law, Ethics & Human Rights at Boston University’s School of Public Health and professor at the Boston University School of Law. Since 1991, Annas has written a regular feature on "Legal Issues in Medicine” for the NEJM, now under the title “Health Law, Ethics, and Human Rights."

On Sept. 7, The New York Times reported Annas’ assessment of the case: The judge’s ruling in the SUPPORT lawsuit “simply meant that the families could not prove the study had caused the injuries, but that did not mean that it had not or that the consent forms, which he argues played a small role in the case, were obtained properly.”[8]

A careful, unbiased journal editor would have sought a legal expert’s opinion before publishing Lantos’ flawed commentary. The decision by Drazen and his senior editors to publish that commentary — as part of their continued effort to defend SUPPORT — tarnishes the reputation of the NEJM.

References

[1] Magnus D, Caplan AL. Risk, consent, and SUPPORT. N Engl J Med. 2013;368(20):1864-1865.

[2] Carlo WA, Bell EF, Walsh MC. Oxygen-saturation targets in extremely preterm infants. N Engl J Med. 2013;368(20):1949-1950.

[3] Drazen JM, Solomon CG, Greene MF. Informed consent and SUPPORT. N Engl J Med. 2013;368(20):1929-1931.

[4] Wilfond BS, Magnus D, Antommaria AH, et al. The OHRP and SUPPORT. N Engl J Med. 2013;368(25):e36.

[5] Hudson KL, Guttmacher AE, Collins FS. In support of SUPPORT — a view from the NIH. N Engl J Med. 2013;368(25):2349-2351.

[6] Lantos JD. Vindication for SUPPORT. N Engl J Med. Published online September 2, 2015. DOI: 10.1056/NEJMp1510876.

[7] Drazen JM, Solomon CG, Morrissey S, Greene MF. Support for SUPPORT. N Engl J Med. Published online September 2, 2015. DOI: 10.1056/NEJMe1511158.

[8] Tavernise S. Premature babies study raises debate over risks and ethical consent. The New York Times. September 7, 2015. http://www.nytimes.com/2015/09/08/health/premature-babies-study-and-judges-ruling-raise-debate-over-consent.html. Accessed September 12, 2015.