science 2008-2009: 10: big pharma and publishing science

When big pharma appears in the courts, the effects can both open up and close down the publishing processes in science. In May 2007, for example, Pfizer found itself in a court case related to its painkillers Celebrex (celecoxib) and Bextra (valdecoxib) and demanded that the New England Journal of Medicine hand over the relevant peer reviews, along the names of reviewers and any documents of internal editorial deliberation. In November 2007, the journal handed over some documents, but not all te company wanted. In 2008, the journal dug its heels in. Pfizer’s lawyers argued that among the papers might be exonerating data vital to Pfizer’s defence. The New England Journal of Medicine’s editors said that the move to strip reviewers of their anonymity would damage peer review. Other editors, such as at Donald Kennedy, Editor-in-Chief at Science, agreed.

Elsewhere, one of the unanticipated consequences of the Vioxx (refecoxib) trial, in which accusations that the drug had serious side-effects hidden from users were rejected by the Merck company, has been to open up documents previously closed, and reveal how trials were published. In 2008, analysts of these documents, writing in the Journal of the American Medical Association, found strong suggestions of ghost writing: ‘one of the Merck-held documents list a number of clinical trials in which a Merck employee is to be author of the first draft of a manuscript’, reported Nature, but in 16 out of 20 cases the name on the finally published article was an external academic.