Sign up for news and updates!






Enter word seen below
Visually impaired? Click here to have an audio challenge played.  You will then need to enter the code that is spelled out.
Change image

CAPTCHA image
Please leave this field empty

Login Form



No, JAMA, You're Doing It Wrong PDF Print E-mail
Swift
Written by Joe Albietz   

Conflicts of interest are a major point of concern within modern medicine. Ideally, physicians and patients want to make decisions based solely upon what is right for the patient; it is what we strive for. In the past it was commonplace for physicians to accept gifts from drug companies, some were small, a pen or a lunch, others were far more substantial. Many physicians thought they could benefit from the drug companies’ attention while remaining unaffected in their medical decision making. They were wrong.

A growing avalanche of studies proved that in spite of physicians’ best intentions, their prescribing practices were clearly influenced by the drug companies. Furthermore, it is very clear that studies sponsored by pharmaceutical companies are statistically more likely to show a favorable outcome for the drug or therapy in question. This was compounded by the fact that money spent advertising directly to physicians had to come from somewhere, and in fact came from the pockets of patients. Such a relationship between physicians and drug companies is a clear conflict of interest and damaged the relationship and trust between physicians and patients.

As a result, most academic institutions, including my own, and many private physicians have stopped accepting any and all gifts from pharmaceutical companies. It is no coincidence that at the time drug company sponsorship was being shunned by physicians that direct-to-patient advertising became more common.

Sometimes it is necessary to work with private companies, though. Even if a drug, vaccine, or tool is developed independently, someone must manufacture and distribute it. Within our current economic system, that is usually a private company. In order to minimize the impact of these relationships, the medical community is attempting to operate with the greatest amount of transparency possible. Most talks, presentations, and papers are now preceded with a disclosure statement where all conflicts of interest, if any, are made clear. (Mine, for the record, is included in my bio).

A failure to disclose a conflict of interest in a publication, when discovered, casts a shadow across the study, its authors, and the paper in which it appeared, even though the omission may have been an honest mistake rather than intentional obfuscation.

It is for this reason that the recent actions of the Journal of the American Medical Association (JAMA) are so unfortunate. In May 2008 JAMA published an article investigating the effect of Lexapro or problem solving therapy on the development of depression in stroke patients which claimed that Lexapro appeared to prevent the onset of depression in stroke patients (1).

After its publication, serious criticisms were raised against the study. One criticism pointed out that though Lexapro was more effective than placebo, it was no better than the problem solving therapy. Thus the recommendation made publicly by its lead author to begin all stroke patients on Lexapro to prevent depression was unwarranted.

The second criticism dealt with undisclosed conflicts of interest. The lead author had served on the speaker’s bureau for Forest pharmaceuticals, the maker of Lexapro. While this does not invalidate the study, it raises the specter that Forest’s influence may have colored the study’s results or presentation, and is therefore important information to be publicly available.

The first of these criticisms was raised in a letter to JAMA and was subsequently published within JAMA. The second concern, the one about conflicts of interest, was likewise brought to JAMA’s attention, but after 5 months was instead published within the British Medical Journal (BMJ), serving as a call to action to hold physicians and researchers to an even higher standard regarding conflicts of interest within medicine (2). The author of the BMJ letter, Dr Jonathan Leo, while he may have sought to publish this criticism within JAMA, was well within his rights to publish it in another journal.

JAMA appears to disagree. Dr Leo received a call from the JAMA executive deputy editor Phil Fontanarosa which was summarized by a JAMA spokesperson as “[JAMA] didn’t think Leo was taking a very good approach by taking this confidential process within JAMA out to media and another medical journal. It’s just not the way things are handled here.” (3) In other words, JAMA is embarrassed that they failed to discover this conflict of interest on their own prior to publication, and would have liked the opportunity to save face. That is understandable. But are they entitled to an internal “confidential process” once a paper is published? In my opinion, no.

JAMA apparently went even further. According to Dr Leo the phone call with Fontanarosa was much more charged, with threats including, “You are banned from JAMA for life. You will be sorry. Your school will be sorry. Your students will be sorry.” The Wall Street Journal’s Health Blogs interviewed JAMA’s editor-in-chief, Catherine DeAngelis about the incident, wherein she referred to Leo as “a nobody and a nothing.”(3) Is it appropriate to “apply pressure” on a critic through their superiors to force a retraction, to ban them from your journal, or to threaten anyone? Absolutely not.

JAMA is apparently determined to undermine public trust in the scientific literature, the foundation of evidence-based medicine. According to the Wall Street Journal on March 23rd, JAMA has now adopted a new policy in which “anyone asserting that study authors have failed to disclose conflicts of interest should keep the matter confidential until JAMA investigates.” (4) The authors of an article and the journal in which it appears do not retain the right to control professional or public discussion over the article once it is published. JAMA may request the option to be the first revise errors in its publication, but cannot censor the writing of others or criticism of its journal.

This incident has been mishandled by JAMA from the beginning. Mistakes happen, even within the best of journals and the most conscientious investigators. The appropriate response from JAMA would have been a prompt and humble correction of whatever error has occurred within its pages (which was done on March 11th, 2009 (5)), and an improvement in quality control within the journal. Not an attempt to silence or intimidate critics, nor the adoption of a policy that amounts to an ineffectual gag order on the medical community.

While we as skeptics rightfully tend to focus on alternative medicine, we cannot neglect to criticize modern medicine when it falls short of the standard. We are trying to broaden the acceptance of evidence and science based medicine, trying to hold all therapies, drugs, researchers and practitioners to the same standards of evidence. In order for this to succeed, the scientific literature must be reliable and transparent. Anything less not only impedes progress but also undermines the public and professional trust in the foundation of the entire project. Everyone will suffer from such a failure, but no one more than the public, the patients. And that is unacceptable.

 

References:

  1. Robinson RG, et al. Escitalopram and Problem-Solving Therapy for Prevention of Poststroke Depression. JAMA. 2008;299(20):2391-2400 http://jama.ama-assn.org/cgi/content/abstract/299/20/2391
  2. Leo, Jonathan. Clinical Trials of Therapy versus Medication: Even in a Tie, Medication wins. BMJ 5 March 2009; 338:b463 http://www.bmj.com/cgi/eletters/338/feb05_1/b463#208503
  3. Armstrong, David. JAMA Editor Calls Critic a ‘Nobody and a Nothing.’ WSJ Health Blog. March 13th, 2009. http://blogs.wsj.com/health/2009/03/13/jama-editor-calls-critic-a-nobody-and-a-nothing/
  4. Armstrong, David. JAMA Sets New Policy in Wake of Disclosure Flap. WSJ Health Blog. March 23rd, 2009. http://blogs.wsj.com/health/2009/03/23/jama-sets-new-policy-in-wake-of-disclosure-flap/
  5. Robinson RG, Arndt S. Incomplete financial disclosure in a Study of Escitalopram and Problem-Solving Therapy for Prevention of Poststroke Depression. JAMA. 2009;301(10):1023-1024. http://jama.ama-assn.org/cgi/content/extract/301/10/1023-a

Disclaimer: Dr Albietz has no ties to industry and no conflicts of interest to disclose. The views expressed by Dr Albietz are his alone, and do not necessarily represent the views of his department or institution. The information provided is for educational purposes only and should not replace a therapeutic relationship with a licensed and accredited medical professional.