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JAMA, Free Speech, and Conflicts of Interest # Springer Science + Business Media, LLC 2009 I recently co-authored a letter to the BMJ, pointing out an increase the market share for Lexapro, the idea of prophy- author’s undisclosed conflict of interest related to a study lactically medicating a large group of people with no psychiatric diagnosis so that a minority of them will not lished in the Journal of the American Medical Association develop depression later on is an initiative worthy of vigorous debate. In this trial they looked at three groups: was really little more than an observation Lexapro, problem solving therapy, and placebo. Both based on a fifteen-second Google search plus some minor Lexapro and therapy beat placebo. Considering that there comments. It was definitely not a groundbreaking piece of are about 6 million stroke patients in the United States, and investigative journalism based on top-secret files, and anyone that, according to several data sets, about 37%, or 2.2 million with access to the World Wide Web could have done the people, will develop depression, this represents a large same. The study we wrote about examined the use of market for the pharmaceutical companies, especially when Lexapro, an SSRI, in stroke patients. The author of the study, you consider it involves prescribing a medication for people a psychiatry professor, had not disclosed that he had served who do not have a diagnosis of depression. Following its on the speaker’s bureau of Forest Pharmaceuticals, the manufacturer of Lexapro. Compared to the recent revelations about academic psychiatrists and their unreported side deals the media as saying that every stroke patient who could worth hundreds of thousands, in some cases millions, of tolerate the medicine should be started on an SSRI. At the dollars with pharmaceutical companies, what we wrote about very least, the slippery slope comes to mind at this point. If was minor. Although our letter said nothing negative about we are going to try and prevent depression in one high risk JAMA, and under normal circumstances would likely have group by treating everybody in the group before they are been read by only a handful of people, the editors were clinically depressed, then what about other high risk groups? extremely upset and their subsequent comments Where do we stop? Should we medicate all the returning veterans (a 20% rate of depression), every pregnant woman to a Wall Street Journal reporter that I was a (10% to 20%), the entire population of foster children (80% “nobody” and “nothing” thrust the issue into the headlines.
rate of psychopathology), and all the medical students in the The ultimate goal of the research group who authored the study is to prevent depression from developing in stroke A week after their “Dr. Nobody” comment, the editors patients not treatment of depression but the prevention of published an editorial, in which they spilt a considerable depression, an important distinction. While it would certainly amount of ink cataloguing my sins, and they used my caseas the impetus for a new policy that puts restraints on whatpeople can say about JAMA. Whereas their initial com- ments could have been brushed off as having been made in “the heat of the moment,” and would have been quickly forgiven in the blogosphere and op-ed pages, this was not Harrogate, TN 37752, USAe-mail: jonathan.leo@lmunet.edu the case with the editorial, which clearly required more time and thought to prepare. The initial comments could also editors released my email correspondence, something I have been attributed to one or two people, but the never did. I was never under any confidentiality agreement subsequent JAMA editorial took on an institutional stamp and statements which imply that I violated a confidentiality of approval. Their editorial has raised several issues that I agreement or interfered with an investigation are untrue and think are important to clarify. Most importantly, I believe impugn my reputation. Interestingly, there seems to be a that there are two distinct sources of disagreement between double standard regarding JAMA’s own policy regarding the JAMA editors and me. The first issue, which I consider the confidentiality of emails. While they had no qualms in relatively minor, is simply a disagreement about the tone of releasing my emails, they have told other letter writers the wording used by the editors when they contacted me following the publication of the letter in the BMJ. Rather than engage in an ongoing argument regarding their tone, I confidential (Healthyskepticism.com).
would prefer to grant the JAMA editors their version of theevents. I hope this will prevent readers from beingdistracted from the more important issue.
Regarding the major issue, the editors were at odds with me and virtually everyone else who had eventually written JAMA has claimed that their investigation was more about it. In short, the editors felt that it was entirely comprehensive than our BMJ piece. I only ask that readers appropriate, as long as they were polite, to contact me and actually compare the material published in JAMA with that my dean, and demand that I withdraw an accurate letter published in BMJ. Granted there were some other undis- written with publicly available information. Drifting into closed conflicts, but the correction published in JAMA does First Amendment issues, they essentially argue that I had not include any analysis of the context or potential no right to write about JAMA without JAMA’s permission. I, implications. For instance, it does not point out that the on the other hand, thought I had the academic freedom to undisclosed conflict with Forest is significant because they write about matters in the public record. I think most people are the same company that manufactures the study drug, believe that once a written body of work, such as a Lexapro. I believe our BMJ letter presents a more complete scientific article, is in the public record, it is fair game for (and troubling) story. However, in light of more recent others to write about it. Isn’t this idea essential to the free exchange of ideas? By creating new stipulations regarding , apparently both of our investigations only the content of comments made on its papers, as well as scratched the surface. Additional allegations have been when those comments could be made, JAMA’s editors raised by Laura Boylan, a neurologist, including: faulty essentially separated themselves from the rest of the clinical trial registration; conflicts of interest that occurred intellectual world, placing themselves in a unique class before JAMA’s required 5-year reporting window; and with their own set of rules. If other organizations ever questions about the investigators’ decision to switch from adopted this JAMA policy and applied it to themselves the free exchange of ideas would be sharply curtailed.
The typical clinical trial generates an enormous amount Throughout this entire matter I repeatedly said that if of data. Once the trial is concluded, there is the potential anyone could point out a factual error in the BMJ letter I problem of researchers selectively picking and choosing the would promptly retract it and issue an apology. Interestingly, data that puts the drug in the best light, while at the same no one, including the JAMA editors, who had every time ignoring the problematic data. This has happened opportunity to do so, ever claimed that my letter contained before with dire results for patients. To prevent this inaccuracies. When faced with demands to retract the article potential abuse, or even the appearance of abuse, the I was in a quandary, as I thought it would be academically editors of the world’s leading medical journals now require dishonest to withdraw a letter that had no factual errors.
researchers to register their study with a publicly available Wouldn’t retraction of the truth be a lie? The JAMA editors clinical trial registry. A key component of trial registration also expressed their disapproval (again, surprisingly, in is that researchers, before they start gathering the data, writing) with the BMJ for publishing the letter. Given that document the endpoints that they consider the most there were no inaccuracies in the letter, it appears that their important. The Robinson post-stroke trial was registered condemnation of the BMJ was based upon the idea that one journal should not publish criticisms of papers published in according to the registry site, which posts all drafts of the registration, the primary endpoints were not posted until The editorial stated that the publication of my letter was August 2008—4 months after the study was published in “a serious ethical breach of confidentiality.” Ironically, the JAMA. This appears to be a direct violation of JAMA’s own editor’s charge about me came in an editorial in which the stated policy. Even a clerical error would seem to be problematic, as it is the editor’s responsibility to verify the organization that funded the study. It is unclear why NIMH, accuracy of the registration. In her article which is supposed to be acting in the best interests of both patients and taxpayers, allowed government funds to be ) describing successful clinical trial registry, spent to investigate the use of the more expensive on-patent the editor-in-chief of JAMA stated, “Every trial participant medication instead of the cheaper generic medication. In her and every investigator should be asking: ‘Is this clinical discussion of these issues, Boylan—in much stronger trial fully registered?’” It appears that the JAMA editors wording than we ever used—stated, “I look to institutions ignored their own advice (See JAMA, Vol. 293, p. 2927).
like JAMA, the NIH, universities, and the peer review While our original letter to the BMJ pointed out that an process to keep the public interest at the fore and maintain author violated a JAMA policy, this new revelation points to information integrity. It seems to me there is much room for JAMA disregarding its own published policy. I would like improvement.” Interestingly, both Dr. Robinson and two of to have inquired of JAMA if this trial was correctly the former psychiatry chairmen mentioned earlier co- registered, but it is unclear to me if my questions would authored a 2005 review which promoted the increased use have qualified as allegations that needed to be investigated of psychotropic drugs for patients with medical illnesses, with me being subject to an indefinite gag order during the such as cerebrovascular disease and alzheimer's disease. The acknowledgement section of their article acknowledges Another point of interest concerns the original editorial support from a ghost writing company approved in 2002, which calledfor the use of Celexa, an SSRI manufactured by ForestPharmaceuticals. A year later, in 2003, the authors switched from Celexa to its close cousin, Lexapro, another Forestproduct. Why the switch? Some background information is One of the assumptions that the JAMA editors have built their necessary. In 2002, as Forest’s patent on Celexa was getting new policy on is that they can do a better job than anyone close to its expiration, the company received patent approval else when it comes to investigating undeclared conflicts in for Lexapro, also an SSRI. With a generic version of Celexa JAMA. I think this is a questionable assumption. As the available, Lexapro was now five times more expensive than following example shows, just requiring professors to list Celexa. Although the clinical trial data showed little difference their affiliations is setting the bar fairly low. In a 2006 study between the two medications, Forest’s introduction of Lexapro involved one of the largest marketing programs in lished in JAMA, the authors concluded that pregnant women the history of antidepressant advertising. (See Melody with a history of taking antidepressants should continue taking their medication. Following the publication of the study, an outside source revealed to JAMA that several of the a more in-depth discussion of the marketing of Lexapro.) authors, who were psychiatry professors, had not revealed all All of a sudden, in 2003, Celexa was passé and Lexapro the companies they were affiliated with (JAMA, vol. 295, was the drug of choice. In their 2008 JAMA paper, the stroke p. 499). The issue received significant media attention study authors cite two papers as justification for the 2003 decision to switch from Celexa to Lexapro. The evidence they cite for this decision seems problematic. The first citation is a thought piece, whose author list ironically the New York Times (7/23/06) bluntly stating: “Their includes three former chairmen of psychiatry departments financial ties were not disclosed to JAMA on the preposterous who resigned from their positions following problematic grounds that the authors did not deem them relevant.” media attention–two because of undisclosed conflicts of JAMA subsequently performed an investigation and published a correction consisting of a simple listing of the authors’ company affiliations, which in the editors’ eyes was sufficient information for the JAMA readers. At this point, neither the general public nor the NYT editors knew the full bad guy? The second citation is a study funded by a extent of the financial relationships involved. It has recently subsidiary of Forest and published in 2005―two years after come to light, according to The Atlanta Journal Constitution the authors actually made their decision to switch. Yet, this switch was not strictly up to the authors. Ultimately, the switch from Celexa to Lexapro was approved by NIMH, the Stowe, a Professor of Psychiatry at Emory University, was paid $253,000 in 2007 and 2008 by Glaxo Smith Kline commented: “This story has what journalists call ‘legs’ with alone. Keep in mind that while JAMA provided a simple some way to run” (BMJ, 3/28/2009). After initially telling listing of the companies involved, the public learned about the WSJ reporter that I was yelled at by the JAMA editors, I the true extent of undisclosed conflicts by virtue of our free really did not do much of anything, other than to sit back and open press; they did not learn about them by reading and watch the daily events unfold. It seemed that at every JAMA. And judging by the fairly extensive media attention turn the editors’ efforts at damage control just led them given to the conflict, the amount of money was an issue for deeper into trouble. For instance, while I was initially in a state of shock when I saw the March 11 editorial, I felt that At one point Dr. Robinson replied to our letter, saying that in the long run the editorial would prove to be very my critical take on psychotropic drugs, which I have never problematic for JAMA and that it would ultimately harm denied, should have disqualified me from publishing a letter in JAMA’s reputation in a way that our letter to the BMJ never the BMJ. He seems to equate thinking critically about did and was never meant to do. I could not fathom how the psychotropic drugs with an “ideologically based mission.” editors themselves could not see that it was problematic.
Considering that I have a track record of writing about the How could they have ever imagined that the press would problematic marketing of psychotropic drugs, I think that he support a gag order? And, as events transpired, the media would have been better off criticizing me on something dealt harshly with the editorial. Following the JAMA specific instead of just accusing me of being biased. I would editorial, multiple newspaper editorials and commentaries welcome any comments from him about what I have written.
were highly critical of JAMA’s new policy. I did not see a In short, over the past decade, I have written several single major organization, medical editor, or news outlet articles pointing out that the benefits of the SSRIs The American Medical Association (AMA) eventually stepped into the fray and asked the JAMA Journal Oversight Committee (JOC) to investigate the matter. Over the next ten overstated, while their side-effects ( several months the JOC, the editors, and the AMA all conducted various meetings about the matter. In my mind, the major question was would the JOC members stand behind the on-line editorial? When the answer finally came entific literature and the media when it comes to discussingthe chemical imbalance theory of depression, and, further-more, that there are significant conflicts of interest involving key opinion leaders in the field. Recently, severalimportant scientific studies ( On July 9, 2009 the new policy came to an end when the JAMA editors published another editorial—this time in the print edition (JAMA, Vol. 302, p. 198). They never disavowed the first editorial or retracted it. (JAMA has also science behind the SSRIs and other psychotropic drugs.
never retracted the CLASS study which led to the And in light of all the recent revelations about just how widespread use and inappropriate use of Celebrex.) Given extensive the financial conflicts are, one critical view of the new editorial’s sharp deviation from the original version, my track record is that I was too naive and never the only conclusion I can draw is that the JOC did not understood the true extent of the problem. Ten years ago support the on-line version. The new editorial deletes all I questioned the use of stimulants in 3-year olds. At that references to me and takes a much softer stance on handling time I never imagined that we would soon be using people who bring undeclared conflicts to the attention of the atypical antipsychotics for toddlers. In Florida alone, in JAMA editors. Rather than require people to maintain silence 2006, more than 18,000 children on Medicaid were during JAMA’s investigation, the print editorial states, JAMA prescribed antipsychotic medications, and 367 of them will request that they maintain silence. While the on-line editorial accuses me of "breaking a confidentiality agree-ment," the newer editorial simply maintains that "theinvestigation is likely to be enhanced by maintaining confidentiality." Yet, the status of the original editorial isunclear. While there is no official retraction per se, the The initial disagreement between JAMA and me had about a original editorial has been removed from the JAMA website.
2-week life span in the media. Another journal editor The editors appear to have taken the stance that it never existed. Apparently, the ink they split earlier was of the Stowers, and the rest of the administration and students at Lincoln vanishing kind. However, the fact remains that numerous Memorial University for their support during this time. I would like to people wrote about the on-line editorial. If the editorial never thank Jeffrey Lacasse and Colleen Salomon for their editorial support.
existed then what did they write about? I think the originaleditorial should still be part of the literature.
catalyst behind this firestorm, it is only appropriate for me to be The new policy also seems to put some burden on the press.
forthcoming. While I do not have a financial conflict of interest, my Under the new policy, an investigative reporter who notices a ideological conflict is that I believe that the relationship between problematic unreported conflict-of-interest in JAMA needs to academic medicine and the pharmaceutical industry is not healthy and first contact JAMA before writing about it. There are already the clinical trial process has become tainted by marketing pressures. Ialso believe that, unfortunately, medical journals shoulder part of the blame for this situation. This state of events has resulted in patients being given only a partial presentation of the science behind many of of reporters writing about undisclosed conflicts without the medications they take. While I look at all of these problems as obtaining prior permission from journal editors. Is it in the ideas worthy of debate, some see this viewpoint as a declarableconflict of interest. I am a member of the Society of Neuroscience, the public’s best interest for news organizations and journals to Association of Clinical Anatomists, and I am a newly enrolled broker secret deals about when to write about something? member of the American Civil Liberties Union.
Isn’t this just another conflict of interest? In a society thatprizes freedom of the press, a policy that puts constraints onthe open and free exchange of publicly available information Armstrong, D. 2009. AMA requests probe of JAMA charges. Wall Boyle, L. Beyond the JAMA flap. 2009. Healthy Skepticism. Available With every new chapter in the saga I kept wondering who DeAngelis, C. D., & Fontanarosa, P. B. 2009a. Resolving unreported conflicts of interest. JAMA, 302, 198 Available at: could possibly be advising JAMA on its course of action.
What if the editors had followed a different strategy, perhaps DeAngelis, C. D, and Fontanarosa, P. B. 2009b. Conflicts over issuing a statement such as: “Authors Beware! We do not conflicts of interest, JAMA. Available at have the ability to police all our contributors’ conflict- Editors. Jammed by JAMA. Chicago Tribune, March 28, 2009.
of-interest declarations. In the past we have relied upon the Leo, J, and Lacasse, J. 2009. Clinical trials of therapy versus honesty of the authors, but now in the age of the Internet we medication: even in a tie medication wins. BMJ, Rapid can also rely upon our loyal readers. As this case shows, our readers are checking up on you.” Case closed. The editors had Robinson, R. G., et al. 2008. Escitalopram and problem-solving multiple opportunities to issue such a statement. They could therapy for prevention of poststroke depression: a randomized have done so at the very start of these events, or later, in controlled trial. JAMA, 299(20), 2391–2400.
conversations with the WSJ reporter, or when speaking withother reporters. And, in contrast to what did happen, themedia would have praised JAMA for once again being in the Jonathan Leo, AKA Dr. Nobody, is Professor of Neuroanatomy atLincoln Memorial University-DeBusk College of Osteopathic Medicine.
forefront when it comes to handling conflicts of interest.
He is co-editor of the recently released book: Rethinking ADHD: From Even better, no one would have ever heard of me.
Brain to Culture, published by Palgrave Macmillan.

Source: http://www.narpa.org/jama_leo_society.pdf


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