Published online 5 March 2008 | Nature 452, 6-7 (2008) | doi:10.1038/452006a

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Crunch time for peer review in lawsuit

Ruling imminent on Pfizer's challenge to journal confidentiality.

Pfizer wants to obtain peer reviews relating to Celebrex.Pfizer wants to obtain peer reviews relating to Celebrex.M. NGAN/AFP/GETTY IMAGES

A US magistrate is set to rule next week on whether the drugmaker Pfizer can force <i>The New England Journal of Medicine</i> (<i>NEJM</i>) to hand over confidential peer reviews as part of litigation involving two controversial painkillers.

Pfizer, the world's largest drug company, subpoenaed the medical journal last May to surrender peer reviews, the names of peer reviewers and internal editorial deliberations for 11 recent papers related to the painkillers Celebrex (celecoxib) and Bextra (valdecoxib). It also wants all other manuscripts the journal has received involving either drug. Most of the studies were published in 2005 and 2006 after Bextra and Vioxx (another drug in the same class of COX-2 inhibitors) were withdrawn because of serious side effects.

Pfizer, based in New York, is defending Celebrex and Bextra in lawsuits charging that they caused heart attacks and strokes. Bextra was pulled from the market in 2005; Celebrex is still available. The drugmaker is trying to obtain the <i>NEJM</i> reviews as part of its defence in the US district court in northern California, where several lawsuits relating to the drugs have been consolidated.

In November, the <i>NEJM</i> turned over 246 pages of documents, but included only its communications with the named authors of the papers, and their financial disclosures.

Pfizer offered to remove the names of individual peer reviewers from any documents the journal provided — but the <i>NEJM</i> still resisted. In January, the drug company filed a motion to force the <i>NEJM</i> to hand over the peer reviews and any other manuscripts. “Scientific journals such as <i>NEJM</i> may have received manuscripts that contain exonerating data for Celebrex or Bextra, which would be relevant for Pfizer's causation defence,” its lawyers wrote. “The public has no interest in protecting the editorial process of a scientific journal, particularly not when doing so prevents a defendant from access to potentially exonerating evidence.”

Responding in an affidavit, Jeffrey Drazen, <i>NEJM</i> editor-in-chief, argued that if the company prevails, there could be “serious adverse consequences” for the scientific peer-review process, including the ability of journals to recruit reviewers, who will be wary of “the possibility that their volunteer work would land them in the middle of litigation”. He wrote that removing names would not be enough to disguise reviewers, given the small number of experts in any one area, who can easily identify each other through their arguments.

Similarly, he argued, free-flowing discussion among <i>NEJM</i> editors would be stemmed “if litigants were able to pick apart this internal editorial process to serve their own needs”.

Scientists and editors have rallied to the <i>NEJM</i>'s cause. Donald Kennedy, editor-in-chief of <i>Science</i>, calls Pfizer's efforts a “fishing expedition” because of its failure to specify what it is looking for. If Pfizer prevails, says Marcia Angell, a senior lecturer in social medicine at Harvard Medical School and a former editor of the <i>NEJM</i>, “it would undermine the whole system of peer review, which depends utterly on confidentiality”.

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Aravinda Chakravarti, a computational biologist and geneticist at Johns Hopkins University in Baltimore, Maryland, says that he can imagine “exceptional circumstances” in which a manuscript review could be submitted as part of litigation, with any potentially identifying information removed. But with Pfizer requesting all of the reviews on 11 papers and possibly more, he says: “I am worried about the precedent. This may benefit Pfizer, but science loses in a big way.”

A ruling is expected on 13 March. 

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