March 25, 2009
Joseph M. Heyman, MD
Chairman, Board of Trustees
Jordan J. Cohen, MD
Chair, JAMA Oversight Committee
Nancy H. Nielsen, MD, PhD
President

American Medical Association
515 N. State Street
Chicago, IL 60654

Dear Dr. Cohen, Dr. Heyman, Dr. Nielsen, and members of the Board of Trustees, and members of the Journal Oversight Committee:

The Alliance for Human Research Protection (AHRP) was founded to ensure that clinical research, which relies on the volunteerism of human subjects, should be as safe as possible, in compliance with ethical and scientific standards [1] and be free of conflicts of interest that undermine both the safety of the subjects and the scientific integrity of the research. Our mission includes protecting the independence of conscientious researchers to analyze reported clinical research findings and, when they occur, to point out ethical lapses in research and publication.

We are deeply concerned about the unbecoming and unethical conduct of the Editor-in-chief and Executive Deputy Editor of the Journal of the American Medical Association, who were reported to have used unprofessional and intimidating tactics against a conscientious academic, Dr. Jonathan Leo. Their behavior undermines the integrity of the JAMA peer review process, first, by failing to properly vet a manuscript for the accuracy of scientific reporting and for author conflict of interest and bias and, second, by launching an ad hominem attack on the scientist who was attempting to correct the record.

The JAMA editors have endangered the public health by failing to correct false information about the comparative benefits and risks of an antidepressant drug. In doing so, the JAMA editors have violated Principle #2 of the AMA Code of Ethics, namely:

"A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities." See: http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/ama-code-medical-ethics/principles-medical-ethics.shtml.

Accordingly, the Alliance for Human Research Protection calls for a public apology to Dr. Jonathan Leo by the American Medical Association, the immediate suspension from duty of the two editors involved in this matter, a thorough investigation by the AMA board of directors, and a commitment to reviewing, clarifying and publishing JAMA's editorial policies to protect against future violations of standards for professional conduct.

The essential facts leading to our complaint follow.

The authors of a JAMA report (May, 2008) [2] recommended the off-label prophylactic use of the antidepressant, Lexapro (escitalopram) to prevent depression in post-stroke patients. The lead author promoted the expanded use of Lexapro in a flurry of media reports. In a letter to JAMA (published Oct, 2008) Dr. Leo, a neuroanatomy professor and assistant dean, and Dr. Jeffrey Lacasse, an assistant professor, raised an important scientific criticism: the authors' failure to compare the two active arms of the study-non-pharmacological, problem-solving psychotherapy to Lexapro. The lead author responded, acknowledging the validity of their assessment, which was that psychotherapy was statistically equivalent to Lexapro.
http://jama.ama-assn.org/cgi/content/full/300/15/1757

Separately, Dr. Leo informed JAMA editors about the lead author's failure to disclose his financial ties to Forest Labs, the manufacturer of Lexapro. After waiting 5 months for JAMA to disclose the author's conflicts of interest to readers, Leo and Lacasse posted a letter in the online British Medical Journal in which they reported the conflict of interest and commented on its implications. [3]
http://www.bmj.com/cgi/eletters/338/feb05_1/b463#208503.

In response, the Wall Street Journal reported that JAMA's Executive Deputy Editor, Phil Fontanarosa MD, threatened Dr. Leo, and JAMA Editor-in-chief, Catherine DeAngelis MD, called the dean of Leo's college demanding a retraction. When interviewed by a Wall Street Journal reporter about this dust-up, JAMA's Editor-in-chief called Leo, "a nobody and a nothing." [4]
http://blogs.wsj.com/health/2009/03/13/jama-editor-calls-critic-a-nobody-and-a-nothing/

Medical journal editors are the gatekeepers of medical science.
Their responsibility is to provide an open forum for scientific debate, and to preserve the scientific integrity of the journal and its content by ensuring against concealed conflicts of interest. Not only have Drs. Fontanarosa and DeAngelis failed to meet this responsibility, they resorted to threatening retribution against a researcher who detected failures in their editing and gatekeeping processes.

This abuse of editorial power is breathtaking.  First, the JAMA editors have violated the AMA Code of Ethics with respect to Principle #2 (as noted above) as well, Principle # 4:

"A physician shall respect the rights of patients, colleagues, and other health professionals..."

Instead, the JAMA editors attacked and attempted to intimidate and punish a responsible researcher who tried to correct the record regarding a misleading JAMA report (May 2008) [2] that failed to report that talk therapy proved equally effective to Lexapro.

It appears that the JAMA editors were enraged by the fact that their editorial failings were exposed in a reputable medical journal. In the first place, they had missed the sensitive point made by Drs. Leo and Lacasse that the evidence showed the antidepressant Lexapro was no better than talk therapy in preventing post-stroke depression. (Competent peer-review of the report should have brought up this point.) In the second place, it was evident that the JAMA editors had to be prodded to reveal conflicts of interest involving the first author of a JAMA report-only after Drs. Leo and Lacasse posted a letter on the BMJ website, ten months after the original publication of the widely cited JAMA report, and five months after Dr. Leo brought the conflict of interest issue to the attention of JAMA. http://www.bmj.com/cgi/eletters/338/feb05_1/b463#208503.

Second, the JAMA editors have violated several principles of the International Committee of Medical Journal Editors (ICMJE), for example Principle II.D Conflicts of Interest:

"Public trust in the peer-review process and the credibility of published articles depend in part on how well conflict of interest is handled during writing, peer review, and editorial decision making." See: http://www.icmje.org/.

The editors' anger was compounded by their failure to suppress disclosure that JAMA's editorial/peer review process leaves much to be desired. JAMA has more than once published promotional-as opposed to scientific-reports by authors with undisclosed financial ties to manufacturers whose products they recommended [5] [6] [7]
http://www.ahrp.org/cms/content/view/544/9/

Third, the JAMA editors have violated several principles of the World Association of Medical Editors (WAME), most notably:

"Journal editors and authors have a responsibility to protect the integrity of the research record from bias related to the funding of research. This is best accomplished by revealing to readers the sponsorship of the research, any roles the sponsor played in the research, the institutional affiliations of the researchers and any relevant financial ties the researchers might have."
See: http://www.wame.org/resources/policies.

The JAMA editors' outrageous unprofessional conduct has ignited quite a firestorm of discontent among physicians:
Questions are also being raised about whether drug advertising influences JAMA's publication of biased reports?  Many JAMA subscribers identify themselves as one of the "nothings" for whom Dr. DeAngelis has shown contempt.  Her arrogance touched off an outpouring of 158 angry responses posted on the Wall Street Journal Health blog, the majority posted by physicians, several respondents indicated they are canceling their JAMA subscriptions.
http://blogs.wsj.com/health/2009/03/13/jama-editor-calls-critic-a-nobody-and-a-nothing/tab/comments and http://blogs.wsj.com/health/2009/03/23/jama-sets-new-policy-in-wake-of-disclosure-flap/tab/comments/

The Editors' response in a JAMA editorial (March 18) adds insult to injury.
In their response, posted online a week after The Wall Street Journal reported on their unethical conduct, Drs. DeAngelis and Fontanarosa failed to offer an apology to Dr. Leo or to address their own unconscionable behavior. Instead, they further demonstrated their arrogance by proposing total secrecy during the unspecified time that JAMA takes to verify allegations of conflicts of interest-in order to protect the reputation of authors  alleged to have undisclosed conflicts of interest. Incredibly, they show a complete lack of regard for their readers and medical colleagues who rely on JAMA reviewers and editors to ferret out biased reports before they are published in JAMA.

Drs. DeAngelis and Fontanarosa propose "modifications" to the JAMA conflicts of interest policy requiring that a person who alleges conflicts of interest about a published JAMA author not only provide detailed "explanations" for the allegation, but take an oath of silence until JAMA deigns to complete its investigation!  The arrogance and imperious tone of JAMA's editors is stunning.

As one of the commentators (#98) on the WSJ Health Blog noted:  "Since when is writing a thoughtful letter to a medical journal, that raises legitimate and accurate concerns, "inappropriate"? Dr. Leo does not work for JAMA. He does not need to abide by the internal "procedures" (which were never communicated to him in any event) forbidding his contacting other journals or the media."

Clearly, the JAMA editors fail to recognize the logical absurdity of claiming the exclusive right to be the sole judge and communicator (in their own time and manner) of errors or omissions in JAMA-unless, their objective is to alienate, and therefore lose JAMA readership. As a consequence of their "modification"-which amounts to a declaration of unilateral control-conscientious  scientists who find scientific errors and / or undisclosed conflicts of interest in JAMA reports, will be advised to report them to reputable medical journals such as, the BMJ (British Medical Journal).

Clearly, the editors show no concern about the adverse impact on patient care resulting from JAMA reports that are tainted by undisclosed conflicts of interest. Ten months elapsed between publication of the original paper, and delayed publication of a correction. The intent of the original paper, as demonstrated by the lead author's role in the media flurry that followed it, was to broaden antidepressant prescribing prophylactically to stroke patients. [8] The lead author's failure to (a) acknowledge that problem solving therapy was equally efficacious in the prevention of depression in the original paper, and (b) mention his financial conflict of interest, were likely designed to strengthen the paper's promotional impact.  Patient care suffers from such maneuvers. 

Clearly, the editors show no concern about the reputation of Jonathan Leo.  And they still have no idea how far over the line they have gone, and how they have lost all respect from their readership, including the eroding membership of the American Medical Association. [9]
http://www.highbeam.com/doc/1G1-132978192.html

The Alliance for Human Research Protection calls for a public apology to Dr. Jonathan Leo by the American Medical Association, the immediate suspension from duty of the two editors involved in this matter, a thorough investigation, and a commitment to reviewing, clarifying and publishing JAMA's editorial policies.

Please kindly inform us of your actions with respect to this formal complaint.

Yours truly,

Vera Sharav, President

On behalf of the Board of Directors
Alliance for Human Research Protection

References:

1. World Medical Association. Declaration of Helsinki http://www.wma.net/e/policy/pdf/17c.pdf
2. Robert G. Robinson, MD; Ricardo E. Jorge, MD; David J. Moser, PhD; Laura Acion, MS; Ana Solodkin, PhD; Steven L. Small, PhD, MD; Pasquale Fonzetti, MD, PhD; Mark Hegel, PhD; Stephan Arndt, PhD. Escitalopram and Problem-Solving Therapy for Prevention of Poststroke Depression: A Randomized Controlled Trial JAMA. 2008;299(20):2391-2400.
3. Leo J and Lacasse J. Clinical Trials of Therapy versus Medication: Even in a Tie, Medication wins. Letter BMJ, 5 March 2009. http://www.bmj.com/cgi/eletters/338/feb05_1/b463#208422  
4. Armstrong D. JAMA Editor Calls Critic a ‘Nobody and a Nothing', Wall Street Journal Health Blog, March 13, 2009. http://blogs.wsj.com/health/2009/03/13/jama-editor-calls-critic-a-nobody-and-a-nothing/. See also, Armstrong D. Medical Journal Decries Public Airing of Conflicts, WSJ, March 23, 2009. http://online.wsj.com/article/SB123776823117709555.html
5. Hypericum Study Group. "Effect of Hypericum perforatum (St John's Wort) in Major Depressive Disorder:  A Randomized Controlled Trial," JAMA Vol. 287, April 10, 2002. at: http://jama.ama-assn.org/article

6.   Kupfer and Frank. Placebo in Clinical Trials for Depression:
Complexity and Necessity, JAMA.2002; 287: 1853-1854.

7.   Kurth T, Gaziano JM, Cook NR, et al. Migraine and risk of cardiovascular disease
in women. JAMA. 2006;296:283-291.

8.   "Antidepressants help stroke victims," May 28, 2008: USA Today:
http://www.usatoday.com/news/health/2008-05-27-stroke-depression_N.htm Associated Press: http://www.foxnews.com/story/0,2933,358948,00.html?sPage=fnc/health/heart  

9.   Bloom M. New Leader Makes Plans to Revive a Faltering A.M.A., The New York
Times, December 4, 2001, F-6.

cc: AMA Board of Trustees:

Kendall S. Allred; Joseph P. Annis, MD; Peter W. Carmel, MD; William A. Dolan, MD; Andrew W. Gurman, MD; William A. Hazel Jr, MD; Cyril M. Hetsko, MD;

Joseph M. Heyman, MD (chair); Ardis D. Hoven, MD; Christopher K. Kay; Edward L. Langston, MD (immediate past chair); Jeremy A. Lazarus, MD; Mary Anne McCaffree, MD; Nancy H. Nielsen, MD, PhD; Rebecca J. Patchin, MD (chair-elect); J. James Rohack, MD; Samantha L. Rosman, MD; Steven J. Stack, MD; Robert M. Wah, MD; Cecil B. Wilson, MD

Cc: JAMA Oversight Committee:

Jordan J. Cohen, MD (chair), George Washington University, Washington, DC
Karen Antman, MD, Boston University, Boston, Mass.
Kathleen Case, American Association for Cancer Research, Philadelphia, Pa.
Steven L. Kanter, MD, University of Pittsburgh School of Medicine, Pittsburgh, Pa.
Robert A. Musacchio, PhD, American Medical Association, Chicago, Ill.
Olufunmilayo Olopade, MD, University of Chicago School of Medicine, Chicago, Ill.
Edward H. Shortliffe, MD, PhD, University of Arizona College of Medicine, Arizona
State University, Phoenix, Arizona