CHICAGO, Illinois—Medical journal editors, peer reviewers, authors, and readers breathed somewhat easier on March 14 after US Magistrate Judge Arlander Keys rejected a demand by Pfizer Inc for access to confidential peer review records for research papers pertaining to celecoxib (Celebrex®) or valedcoxib (Bextra®). This is 1 of 2 cases: one brought in Illinois because the Journal of the American Medical Association (JAMA) and Archives of Internal Medicine (AIM) are based in Chicago, the other brought in Massachusetts because The New England Journal of Medicine is a publication of the Massachusetts Medical Society.
“Although [JAMA editor-in-chief Dr. Catherine DeAngelis’s] statements are quite dramatic, it is not unreasonable to believe that compelling production of peer review documents would compromise the process. Pfizer has offered nothing to counter these very real concerns; nor has it explained how redacting the names of the ‘peers’ would stem that tide. Because of this, the court finds that whatever probative value the requested documents may have (and it is little, if any) is outweighed by the burden of compliance.”—Magistrate Judge Arlander Keys.

Subpoenas asked for all peer review documents, comments, names

In a motion to compel1 after editors from JAMA and AIM had refused to comply with subpoenas, Pfizer asked for copies of
  • “all documents regarding manuscripts submitted for publication [to JAMA and AIM], whether accepted or rejected, concerning Bextra or Celebrex”
  • “all documents regarding the decision to publish or not publish any manuscripts submitted for publication to [JAMA and AIM], whether accepted or rejected, concerning Bextra or Celebrex”
  • “all documents regarding the peer review process or other assessment, analysis, or evaluation of any manuscripts submitted for publication to [JAMA and AIM], whether accepted or rejected, concerning Bextra or Celebrex”
  • “all documents which identify or constitute the names, affiliations, and/or comments of each person who engaged in the peer review or other assessment, analysis, or evaluation of any manuscripts submitted for publication to [JAMA and AIM], whether accepted or rejected, concerning Bextra or Celebrex.” (Pfizer eventually renounced asking for the names of peer reviewers.)


According to Judge Keys, the goal of this vast fishing expedition was to unearth “documents that might possibly contain something to counter what was reflected in the medical literature.”

The journals argued that releasing such information would wreck the peer review process, which in the words Science editor-in-chief Donald Kennedy, MD, depends on “the volunteer services of thousands of experts all over the world who willingly provide, without compensation, confidential and candid evaluations of the work of others.”2

Judge agrees peer review confidentiality should be protected

Judge Keys agreed. “Indeed, according to Catherine DeAngelis...editor-in-chief of JAMA, that promise of confidentiality is what allows the peer review process to work in the first place,” he wrote. “...Dr. DeAngelis represents in her declaration that, if the journals are forced to produce the peer reviewers’ comments, evaluations, and analyses, the medical community will ‘suffer a severe decline in medical reviewers willing to accept additional requests to participate in peer review,’ which will inevitably lead to an erosion in the journals’ ability to ‘properly discharge its mission to advance the betterment of public health.’”

Judge Keys continued, “Although her statements are quite dramatic, it is not unreasonable to believe that compelling production of peer review documents would compromise the process. Pfizer has offered nothing to counter these very real concerns; nor has it explained how redacting the names of the ‘peers’ would stem that tide. Because of this, the court finds that whatever probative value the requested documents may have (and it is little, if any) is outweighed by the burden of compliance.”

Does public have “no interest in protecting the editorial process”?

In the Massachusetts case Pfizer’s attorneys contended, “The public has no interest in protecting the editorial process of a scientific journal...” and anyway, “It is unreasonable to conclude that scientists and academics will stop submitting manuscripts to NEJM if it complies with this subpoena.”3 This displays either touching naïveté or deliberate obtuseness about peer review, because it ignores the effect on reviewers who are promised confidentiality to find their words might be read in open court.

In an editorial published online March 24, following Judge Keys’ decision, Dr. DeAngelis and JAMA editorial counsel Joseph P. Thornton, JD, wrote, “We firmly believe that ensured confidentiality of reviews allows reviewers to provide professional critiques of manuscripts without fearing potential repercussions from authors.... Producing any of these documents, with or without names, would seriously compromise the process and the trusting relationship among the editors, authors, and reviewers.”4

The motion to compel NEJM to reveal peer review documents is pending in the US District Court in Massachusetts, and a decision is expected within the next few weeks.

References

1. Pfizer v JAMA and AIM, 1 F Supp 2, 8 (ND Ill, E Div 2008).
2. Kennedy D. Confidential review—or not? (editorial) [published online ahead of print February 22, 2008]. Science. 2008; doi:101126/science.1156250. http://www.sciencemag.org/cgi/content/summary/319/5866/1009.
3. Pfizer v MMS and NEJM, 1 F Supp 13 (D Mass 2008).
4. DeAngelis CD, Thornton JP. Preserving confidentiality in the peer review process (editorial) [published online ahead of print March 24, 2008]. JAMA. 2008; doi:10.1001/jama.299.16.jed80000. http://jama.ama-assn.org/cgi/content/full/299.16.jed80000v1.