Thursday, February 04, 2010

The Lancet - The perils of journal and supplement publishing

Some years ago, The Lancet's editors were asked to consider the publication of commercially sponsored supplements. We were against the idea. But the circumstances at the time led us to experiment with the proposal. It was a disaster. The supplement papers—all reviews—that were sent to us all failed at peer-review. Our reviewers sent us the strong message that to publish supplements at all would signal a commercial step too far. Supplements are now firmly off this journal's agenda.

That said, it would be foolish and naive to ignore the fact that supplements and custom publications are a familiar part of modern journal, including society journal, publishing. They can be made to work, although research suggests that the quality of supplement material is usually much inferior to that of any parent title. Elsevier, our publishers, produces supplements with many of its journal titles with success and without controversy, although recent publicity around an Australian non-journal paid for by a sponsor and not acknowledged as such was deemed “unacceptable practice” by Elsevier publishers last year.

Supplements to medical journals and custom publications can therefore cause a great deal of trouble to editors. An interesting twist to what a supplement is landed in our office recently. Accompanying the January, 2010, issue of the Annals of Rheumatic Diseases was a supplement on “Advances in targeted therapies XI”. It looks like the parent journal (the cover and layout are identical) and it contains a summary of presentations to a meeting. The preface to the supplement reports that “The pharmaceutical industry had no part in the decisions about the specific programme and, with the exception of a few observers, participants were selected and solely invited by the Organising Committee”. The conference was supported by unrestricted educational grants from seven companies. So far, so usual in the world of supplement publishing.
With the journal and supplement was a very different publication branded “Satellites”, and co-branded with the logos of a pharmaceutical company, NicOx, and Affinity, “a publishing service provided by BMJ Group”. NicOx is, according to its website, “dedicated to the development of nitric oxide donating drugs”. The symposium on which the content of this supplement is based was funded by NicOx. The company has had a new drug application filed with the US Food and Drug Administration (FDA)—naproxcinod for osteoarthritis—since September, 2009. The FDA has set an “action date” of July 24, 2010 to make a decision on its approval. The evolution of expert opinion about naproxcinod in advance of that meeting may be an important influence on the FDA's thinking.

The publication of this “Satellites” supplement with the official journal of the European League Against Rheumatism (EULAR) is a coup for NicOx. It looks as if EULAR's decision to allow this supplement to be mailed with its own journal is close to an endorsement of naproxcinod in the run up to the FDA's decision. Especially so when the editor of the parent journal has written an article for the supplement.

Affinity's website calls “Satellites” an “on-demand publication service”. It says that “approved content is supplied by the sponsor, with editorial management and production undertaken by BMJ Group editorial staff”. It adds that “Satellites are not peer-reviewed by BMJ Group”. This policy seems problematic when it concerns a supplement that contains an Introduction (which misleadingly states that “the articles…represent the current state of the art in the pharmacological management of OA [osteoarthritis]”), together with three articles, two of which are dedicated largely to the subject of nitric oxide in inflammation and naproxcinod as an “attractive alternative” to existing therapies. It is even more problematic when naproxcinod is undergoing FDA review at the same time as the publication and wide distribution of this non-peer-reviewed supplement.

Some may argue that supplements and custom publications are routinely thrown away, so why worry. But the deliberate effort to subvert peer-review at a delicate time for an as yet unlicensed product should be a cause for concern. Others may say that this kind of publication is no worse than display advertising. Except that a display advertisement can only be for a licensed product, which naproxcinod is not. It may even be said that the publisher is only providing a publishing and distribution service, with no implied oversight or endorsement by the parent journal title. But again, this would be an attempt to evade responsibility. The supplement was, after all, sent out with that parent journal.

Publishing supplements is a perilous business. And editors will always need to be vigilant in making sure that their journal's good name is not abused.

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