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

in Public Citizen’s October Health Letter

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 (see references). 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. 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 —> Read More