Jim Fitzpatrick, an attorney with Hughes, Hubbard and Reed who helped represent Merck in its Vioxx litigation, said all authors on Merck studies had input on them. It is part of the scientific process to list authors with varying degrees of involvement, he said in a telephone interview. ``Merck's expectation is if a scientist is an author on a paper, then he or she agrees with the paper, has had the opportunity to comment and make revisions,'' Fitzpatrick said. ``I think it does give the paper more credibility if there is a respected outside author that has reviewed and edited the content of the paper.''
If those are Merck's "expectations" for authorship, then Merck science seems seriously troubled, indeed.
This seems typical of the kind of debased "science" I experienced in the pharmaceutical industry, where, for example, IT personnel decided on what information assets drug discovery scientists could utilize, and in fact rationed and eliminated those assets based on their own idiosyncratic, science-ignorant whims, e.g., determine which specialty information repositiories to eliminate on the basis of "cost per user per database."
(Anyone who wants to better understand the dysfunctional "inner workings" of big pharma science might study the stories here, here and here.)
Fortunately, on the issue of biomedical authorship, there are "higher authorities" than a lawyer or a pharma company:
International Committee of Medical Journal Editors
Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication
Updated October 2007
... II.A Authorship and Contributorship
II.A.1. Byline Authors
An “author” is generally considered to be someone who has made substantive intellectual contributions to a published study, and biomedical authorship continues to have important academic, social, and financial implications. (1) In the past, readers were rarely provided with information about contributions to studies from those listed as authors and in acknowledgments. (2) Some journals now request and publish information about the contributions of each person named as having participated in a submitted study, at least for original research. Editors are strongly encouraged to develop and implement a contributorship policy, as well as a policy on identifying who is responsible for the integrity of the work as a whole.
While contributorship and guarantorship policies obviously remove much of the ambiguity surrounding contributions, it leaves unresolved the question of the quantity and quality of contribution that qualify for authorship. The International Committee of Medical Journal Editors has recommended the following criteria for authorship; these criteria are still appropriate for those journals that distinguish authors from other contributors.
Authorship credit should be based on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.
Note the statement: Authors should meet conditions 1, 2, AND 3. I don't believe prominent acacemics who add some "spit and polish" to ghostwritten articles qualify.
... When a large, multi-center group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript (3). These individuals should fully meet the criteria for authorship/contributorship defined above and editors will ask these individuals to complete journal-specific author and conflict of interest disclosure forms.
When submitting a group author manuscript, the corresponding author should clearly indicate the preferred citation and should clearly identify all individual authors as well as the group name.
Journals will generally list other members of the group in the acknowledgements.
The National Library of Medicine indexes the group name and the names of individuals the group has identified as being directly responsible for the manuscript.
Acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify authorship.
All persons designated as authors should qualify for authorship, and all those who qualify should be listed. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.
Some journals now also request that one or more authors, referred to as “guarantors,” be identified as the persons who take responsibility for the integrity of the work as a whole, from inception to published article, and publish that information.
Increasingly, authorship of multi-center trials is attributed to a group. All members of the group who are named as authors should fully meet the above criteria for
authorship/contributorship.The group should jointly make decisions about contributors/authors before submitting the manuscript for publication. The corresponding author/guarantor should be prepared to explain the presence and order of these individuals.
It is not the role of editors to make authorship/contributorship decisions or to arbitrate conflicts related to authorship.II.A.2.
Contributors Listed in Acknowledgments
All contributors who do not meet the criteria for authorship should be listed in an acknowledgments section.
Examples of those who might be acknowledged include a person who provided purely technical help, writing assistance, or a department chair who provided only general support.
Editors should ask corresponding authors to declare whether or not they had assistance with study design, data collection, data analysis, or manuscript preparation. If such assistance was available, the authors should disclose the identity of the people that provided this assistance and the entity that supported it in the published article.
Financial and material support should also be acknowledged. Groups of persons who have contributed materially to the paper but whose contributions do not justify authorship may be listed under a heading such as “clinical investigators” or “participating investigators,” and their function or contribution should be described—for example, “served as scientific advisors,” “critically reviewed the study proposal,” “collected data,” or “provided and cared for study patients.”Because readers may infer their endorsement of the data and conclusions, all persons must give written permission to be acknowledged.
It seems many of the so-called "authors" of these ghost authored papers should have been listed not as authors but as "participating investigators" or "scientific advisors." An example might be this person:
... Steven H. Ferris, a neuropsychologist at New York University School of Medicine who is listed as the second author, said [the charges of ghost authorship were] ... not true. He said he was on a committee that reviewed the clinical records of 195 patients who received diagnoses of Alzheimer's during the study -- a task that took many hours, and for which he was paid.'I was directly involved in a very substantive way,' he said this week.
While such a person may have been involved "in a substantive way", it does not appear to me that this rises to the level of authorship per the ICMJE requirements. "Scientific advisor" would have been a more precise term.
Perhaps the most unfortunate issue is that I believe the academics who've listed themselves as authors, and who stand behind that assignment in the recent articles on this controversy, actually feel entitled to such a designation. I truly believe that they believe they qualify as authors and that they lack an understanding of - or don't care about - guidelines such as those of the International Committee of Medical Journal Editors.
That these academics also benefit substantially, both in their academic careers and financially, from accreditation as senior authors in prominent journals once again demonstrates the ethics-debasing effects of conflict of interest.
Besides such self-delusion, part of the problem may also be that those that believe themselves member of an elite class, such as some high-powered academics in biomedicine and lavishly paid executives in industry, do not believe themselves subject to such standards.
Peter Kim's statement that "We are disappointed that such false and misleading statements about Merck from trial lawyers have made their way into a medical journal" suggests Kim, a former academic in a small lab, is not highly familiar with the ICMJE guidelines.
This would not be inconsistent with the debased state of scientific attributionship in academia in general that I have noted in my writings. Academia itself lacks a pristine reputation on handling of intellectual property matters. For example, several years ago bitter authorship disputes were found to be increasingly frequent by the Ombud of Harvard Medical School and felt to affect other academic institutions as well. Even worse, the Harvard Ombud wrote that “it is unreasonable for institutions to promise that they can protect individuals from retaliation for coming forward to complain through formal grievance procedures.”[1] In my response in JAMA I indicated alarm at the latter opinion.[2]
I've had a personal taste of this debasement. Yale professors tried to misappropriate my intellectual property, assisted by a Yale lawyer who was in fact unauthorized to practice law in Connecticut, and tried to use extortionary methods and blacklisting in order to do so. That story is here. (Attached at that link is a pdf presentation on a government investigation of Yale's inability to manage their government grants transparently as well.)
In effect, academic's dysfunction and industry's interests and lack of ethics may have reached an ideal stage of co-dependency, forming an "academia-industrial complex" that has led to today's debasement of biomedicine.
That the inner workings of this "complex" are now being exposed comes at a critical juncture and offers a chance at remediation. With this exposure and with the new information dissemination tools enabled by the Internet (the effects of which were painfully learned by people such as Dan Rather and John Kerry), there may yet be hope for reform.
References:
1. "The Coin of the Realm, The Source of Complaints", Linda J. Wilcox, EdM, CAS, Ombud, Harvard Medical School, Journal of the American Medical Association. 1998;280:216-217, http://jama.ama-assn.org/cgi/content/full/280/3/216
2. "Academic and Legal Aspects of Authorship Disputes" (letter), Journal of the American Medical Association. 1999;281:135-136, http://jama.ama-assn.org/cgi/content/full/281/2/135-a (subscription required)
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