Monday, September 1, 2008

The Latest Of-All-the-Nerve Award

This month's Of-All-the-Nerve Award goes to Steven Ferris, PhD of New York University; Douglas Galasko, MD of UC-San Diego, and Louis Kirby, MD of Provista Life Sciences in Phoenix.

Back in April, JAMA published a paper on ghostwriting, based on revelations from the Vioxx litigation and the resulting disclosure of internal Merck documents (see previous post, As an example of a ghostwritten paper with academic "guest authors," Ross et al. discussed in some depth a paper (Thal et al. 2005) listing these gentlemen as co-authors. The three awardees thereupon wrote an angry Letter to the Editor to JAMA denouncing their inclusion in the article as guest authors.

They insisted that all had had "substantial roles" in designing and carrying out the trial. They then admitted: "The paper was initially drafted by Merck coauthors in August 2003, after discussion of the results had previously taken place with Dr Thal and Dr Ferris in June and July 2003. Drs Thal, Ferris, and Kirby were formally approached about being coauthors on the paper and an associated abstract in September 2003. Each critically reviewed the complete statistical report and contributed to revising the final manuscript."

Having this conceded the major point of the accusation against them--that a Merck ghostwriter had in fact been the real "first author" and that they had seen the paper only after it was sent to them, virtually already completed, by the company--Ferris, Galasko, and Kirby went on to complain: "This unsubstantiated allegation of guest authorship raises questions about flawed methodology in the study by Ross et al. It is poor science to draw broad conclusions about pharmaceutical practices from limited and highly selective information. Moreover, neither the authors nor JAMA contacted the presumed guest authors for comments or clarification regarding this material or the allegation of guest authorship prior to publication. A change in author names does not necessarily mean that those added were not involved: such name changes occur frequently as research manuscripts are revised."

"Unsubstantiated"? Ross et al., in their reply to the Letter, remind the readers that as part of their analysis, they had compared the draft prepared by the Merck ghostwriter with the published article, and found only minor changes in wording and organization--so much for the "contributions" to revising the final manuscript.

It may be of some significance that in order to disclose all of their financial relationships with industry, Ferris et al. required 22 lines of fine print following their Letter.

I guess their theory is that the best defense is a good offense. When caught red-handed passing off a ghostwritten paper as your own work, attack the methodology of the expose.

(Thanks to Roy Poses at the Health Care Renewal blog for guiding my attention to this letter.)

Ferris S, Galasko D, Kirby L. Guest authorship, mortality reporting, and integrity in rofecoxib studies (letter). JAMA 2008; 300(8):901-2.

Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 299:1800-12, April 16, 2008.

Thal LJ, Ferris SH, Kirby L; et al. A randomized, double-blind, study of rofecoxib in patients with mild cognitive impairment. Neuropsychopharmacology. 2005;30(6):1204-1215.

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