Bioethics Discussion Blog: The Story of Dr. Leo and the Journal: Is There an Ethics Lesson to be Learned?

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Monday, March 23, 2009

The Story of Dr. Leo and the Journal: Is There an Ethics Lesson to be Learned?

Here is the story as described by Dr. Leo and was published as a letter in the OnLine Wall Street Journal where you can access the multiple internet reference links to which Dr.Leo provides.


ACADEMIC FREEDOM AND CONTROVERSY OVER THE PUBLICATION OF FACTUALLY CORRECT, PUBLICLY AVAILABLE INFORMATION

Jonathan Leo, Ph.D.

Over the past several years, I have written about the potential impact of conflicts-of-Interest in medicine (COI). I have also watched how the mainstream media reports the results of medical research with great interest. As a neuroanatomist, I was particularly interested in a recent study published in the Journal of the American Medical Association (JAMA), which reported that the prescription of escitalopram lowered the rate of depression in patients who had recently suffered a stroke. I co-authored a letter to JAMA with Dr. Jeffrey Lacasse of Arizona State University, in which we pointed out the problem of selective reporting within the study: Problem-solving psychotherapy was statistically equivalent to escitalopram, but this was never mentioned. In the mass media, the principal investigator recommended that all stroke victims should be prescribed antidepressants without mentioning that problem-solving therapy was statistically equivalent.



In the process of reading this body of research, my co-author and I noticed a problem with the COI disclosures in this positive trial of escitalopram published in JAMA. The principal investigator on the project, Dr. Robert Robinson, had not declared that he had previously received funding from Forest Laboratories, the makers of escitalopram. The financial relationship with Forest Laboratories was well-documented and easily discoverable via a Google search, as evidenced by Dr. Robinsonπs previous self-disclosures in varied sources such as here, here, here, here, and here.

I urge my students to carefully consider COI when they read an article as such conflicts can be important in how one interprets research. I do not consider myself a whistleblower, but I do think that the full story behind clinical trials should be transparent so that patients and doctors can make informed decisions. This instance of unreported COI in a gold-standard study published in JAMA seemed like a perfect case study of problematic COI issues. First, I informed JAMA of what we had found. We then co-authored a commentary describing this saga and the potential implications, linking together the unreported COI, selective reporting in JAMA, and in the mass media. We submitted it to the British Medical Journal (BMJ), who agreed to publish it as a Rapid Response on their website.

Months later, before publishing the BMJ letter, I called JAMA editorial staff twice to talk about the upcoming piece, and I also sent an email. Given the topic of the letter, I wanted to give JAMA an opportunity to correct any factual errors. No one from JAMA responded to my phone calls or email. The letter underwent legal review at BMJ and was approved for publication. We then published what we thought of as a fairly unremarkable letter primarily of interest to researchers who study COI.

The immediate, aggressive response from JAMA has been well documented. Threatening phone calls, personal attacks, and emails were accompanied by demands that we retract the entire BMJ letter.

Our letter was published without any negative commentary regarding JAMA itself, and included the following statement: We are fully aware that JAMA is concerned about conflicts of interest and has taken a leading role in promoting policies to benefit the medical community. We are pleased to report that we learned at the end of business on Thursday (3/5/09) that the JAMA Editorial Staff has looked into this matter and will be discussing it in the forthcoming March 11 issue. Our letter did not attack JAMA and, if anything, presents the facts of the matter flatly.

JAMA continued to ask that the entire piece be retracted. We were stunned by the continued, heated reaction from JAMA, and were concerned that we might have inadvertently made an error of fact in our letter. I made the following offer repeatedly: Please tell me what we have written that is factually incorrect, and if we have made a mistake or misinterpretation, we will retract the entire piece and issue a public apology. No factual errors were ever pointed out. I remain confused as to why JAMA felt they could demand that we retract an accurate letter.

Phone calls were followed by a scathing JAMA editorial which pinpoints my actions as the cause of the problem- with no mention of the culpability of the researchers who failed to disclose their COI, or the fact that the undisclosed COI was unearthed by a 5-minute Google search.

JAMA now insists that it was inappropriate to disclose the COI while they were conducting an investigation. This is curious, for several reasons. First, their investigation was complete by the time our letter was published. Second, the undisclosed COI information contained in the article is publicly available on the Internet (again, here, here, here, here, and here). JAMA has never clarified how the re-publication of publicly available information after the fact could interfere with a completed investigation. This investigation, which took five months, resulted in a short correction published in JAMA, along with a letter from the authors apologizing for their lapse of memory resulting in undisclosed COI. JAMA has claimed that the result of their investigation was more comprehensive than our BMJ piece. I only ask that readers actually compare the material published in JAMA with that published in BMJ. The material published in JAMA does not include any analysis of the context or potential implications. I believe our BMJ letter presents a more complete (and troubling) story.

Importantly, I am under the impression that JAMA objected not to the timing of the publication of the letter, but to us publishing the letter at all. In their most recent editorial, JAMA seems to assert that they have some right to control the publication of publicly available information outside their own medical journal. I do not believe they have any such right. It would seem to be an infringement of academic freedom to threaten academics who analyze publicly stored information. This information was available to anyone with access to the Internet. The view that JAMA should control such information is anachronistic at best. At worse, it is a reflection of a scientifically and ethically inappropriate effort to suppress the free exchange of information, which is at the heart of productive scientific discourse.


The implications of the JAMA's reaction to our letter are significant. For instance, the pharmaceutical industry is often criticized for their impact on evidence-based medicine. In the past, I have criticized direct-to-consumer advertising of psychiatric medications, which is not helpful to Big Pharma. However, I have never been telephoned or threatened by representatives from Big Pharma. In contrast to my experience with JAMA, any exchanges have been civil and appropriate.



The claim that JAMA can control the flow of information in the public record should be considered by bioethicists and other academics who study the process of medical research and publication. In my opinion, this claim has shifted this issue markedly. What began as a short (and potentially obscure) letter about undisclosed COI has now led to questions about the limits of institutional authority in the medical publishing industry, the extent of academic freedom, and even the role of the First Amendment.



Competing Interests: None.

Acknowledgement: Jeffrey R. Lacasse, Ph.D., provided editorial assistance in the preparation of this letter.


The description and views of the entire conflict between JAMA and Dr. Leo and the subsequent changes in the policy of the Journal is available as a free full text Editorial written by the editors in the March 20 2009 Online edition of JAMA and titled "Conflicts Over Conflicts of Interest".

It has been well established that study author conflict of interest with the drug company may affect what is published and what is disseminated to the public. Dr. Leo can be looked upon as a "whistleblower". I do want to know what my visitors think about the Dr. Leo vs JAMA story in terms of how should "whistleblowers" be dealt with in the realm of scientific journal publication of pharmaceutical studies or any other studies where important potential conflicts of interest exist and are exposed. Indeed, isn't it possible that medical journals who publish paid advertisements by the pharmaceutical companies have their own conflict of interest as an ethical concern? ..Maurice.

7 Comments:

At Monday, March 23, 2009 10:47:00 PM, Anonymous TT said...

Dr. Bernstein,

I saw this a few days ago and have taken the time to read the related documents.

Personally I think Dr. Leo's actions were the right thing to do, and I applaud his integrity. Further, it was done in a professional, factual and non-accusatory manner, which is more than can be said for JAMA's reaction.

When any research is published in a major professional journal (medical or otherwise), integrity must be the number one concern. Articles must be carefully reviewed to insure that the results are reported in an unbiased manner. In the JAMA article in question, not only did the article fail to publish the results in an unbiased manner, but the author clearly had a major COI that he conveniently "forgot" to document. Who ever was supposed to review this article blew it big time.

What I find even more disturbing are the condescending and derogatory remarks about Dr. Leo JAMA officials made to the media when contacted about the BMJ letter - IMHO they were nothing short of disgraceful, and I find their arrogance appalling.

TT

 
At Monday, March 23, 2009 11:10:00 PM, Blogger Maurice Bernstein, M.D. said...

TT, thanks for your prompt commentary to my new thread. You know, TT, I just wonder if there was a bit of hypocrisy by the JAMA editors in their notification of Dr. Leo's university dean about Dr. Leo's alleged behavior. They acted as a "whistleblower" themselves but apparently without any due process.
[From the JAMA editorial: "However, since Leo apparently
did not appreciate the serious implications of his actions,
despite our attempts to explain, we felt an obligation to
notify the dean of his institution about our concerns of
how Leo’s actions were potentially damaging to JAMA’s
reputation. We sought the dean’s assistance in resolving
this issue involving a member of the faculty of his institution,
to assure there would be no need to publicly identify
that faculty member. No dean wants his or her institution
implicated in a publication reflecting improper behavior
by a faculty member. We fully expected a professional and
appropriate response and assistance with resolution, as has
occurred when we have notified other deans about related
issues in the past, such as in other cases involving undisclosed
financial conflicts of interestand cases of duplicate
publication."] Oh well, I guies its "the kettle calling the pot black". Again, thanks. ..Maurice.

 
At Tuesday, March 24, 2009 12:12:00 AM, Anonymous TT said...

Dr. B.,

Yeah, I found that statement interesting as well. Hypocrisy, yes - along with a blatant attempt at intimidation - a little ironic, isn't it? As carefully as everything was vetted prior to the letter being published by BMJ, I strongly suspect there's a better than even chance the Dean already knew about it.

Looking at the chronology, the folks at JAMA clearly had more than ample time to exercise the option of taking the high road, but instead chose to react like a combination of spoiled child and offended self-proclaimed deity. Essentially their response was "We're the JAMA - how dare you question us you insignificant miserable little peon!" - hardly the kind of response you'd expect from a major professional journal. IMHO, their own response has done far more to hurt their reputation and image than anything Dr. Leo could have said.

TT

 
At Tuesday, March 24, 2009 6:56:00 PM, Blogger Maurice Bernstein, M.D. said...

Visitors might be interested to go to Orac's blog and read a very complete summary of the JAMA story along with a whole lot of useful links. ..Maurice.

 
At Thursday, March 26, 2009 3:03:00 PM, Blogger Maurice Bernstein, M.D. said...

Gordon F. Moran wrote me the following e-mail and gave me permission to post it here. ..Maurice.

Regarding the Leo/JAMA dispute, here are a few comments from the standpoint of academic ethics and bioethics (I am the author of the book Silencing Scientists and Scholars in Other Fields: Power, Paradigm Controls, Peer Review, and Scholarly Comunication (Ablex, 1998), and I am working on a follow up text relating to obstacles that scholars face when they try to correct error that they detect in the mainstream scholarly literature.):
1) JAMA had plenty of time (four or five months or so) to publish their (and Prof. Robinson's) hidden conflict of interest before Leo published in BMJ's Rapid Responses. Why the delay?
2) Their treatment of Leo during those months seems to resemble stonewalling and a personal brushoff.
3) As Leo mentions, it did not require much time to determine if Robinson had a conflict, and if he did, to publish it. A phone call, an email, or a quick Internet search was all that was needed.
4) JAMA's action indicated they did not want to reveal the conflict, and got very annoyed when someone else did.
5) There appears to be a serious rhetoric vs reality gap in high places (JAMA, NEJOM, etc) about conflicts of interest. (On the Science and Democracy website there is a recent item about editors and editorial board members being rife in conflicts of interest, not listed on the joural's letterhead, at the same time that journals ask authors to reveal their own similar conflicts.)
6) Even groups that purport to reveal conflicts of interest, might be remiss in clamorous cases. As of yesterday, the Integrity in Science Watch database did not list any conflicts at all for Prof. Robinson (despite all the fuss and discussion among Leo, JAMA, and BMJ), neither under his name, nor under University of Iowa.
7) I don't think, from the standpoint of academic ethics, that a revelation of specific hidden conflicts of interest should result in retaliation against the revealer/whistleblower, nor should such a revelation evoke highly negative, derogatory criticism. All the more so if these hidden conflicts can already be found in sources such as Internet.
8) JAMA has periodically organized Peer Review congresses. At least one recent congress was sponsored/subsidized by big, powerful drug companies, and a submitted article (abstract for article) that discussed the ethics of peer review was rejected.

The list can go on, but I think what has happened so far would indicate that an editorial house cleaning at JAMA, rather than criticism of Leo, would be best for JAMA's reputation.

 
At Wednesday, October 13, 2010 7:27:00 PM, Anonymous Anonymous said...

I experienced similar intimidation reprisal and defamation in the hands of some of the same organizations for blowing the whistle on medical ethics and coi issues.who should I contact for help since it cost my career.ss

 
At Wednesday, October 13, 2010 7:41:00 PM, Blogger Maurice Bernstein, M.D. said...

ss, obviously I don't know the details of your issue but if the matter is significant enough for you to take legal action, talking to a lawyer would be a next step. ..Maurice.

 

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