JAMA Editor Should Apologize & Resign

A report on the Wall Street Journal blog, “JAMA Editor Calls Critic a ‘Nobody and a Nothing’” (March 13, 2009) describes the unseemly conduct of both the Editor-in-Chief and the Executive Deputy Editor of the Journal of the American Medical Association—Catherine DeAngelis MD and Phil Fontanarosa MD—who are reported to have made intimidating phone calls to Dr. Jonathan Leo, a professor and a researcher who posted a critical letter co-authored by Dr. Jeffrey Lacasse, on the Web site of the British Medical Journal (March 5, 2009) [1] 

The letter addressed two major flaws in a study that appeared in JAMA last spring. [2]
The study randomized stroke patients who were depressed to three groups: problem-solving therapy; the antidepressant, Lexapro; and placebo. However, the authors failed to compare the drug to the alternative non-drug treatment, concluding that Lexapro was beneficial in treating post-stroke depression. Drs. Leo and Lacasse pointed out that problem-solving therapy proved as equal to the drug—without the serious risks posed by the drug. The second criticism was directed at the lead author’s failure to disclose a relevant conflict of interest. [details below]
According to Dr. Leo, JAMA deputy editor, Fontanarosa threatened him stating:
“Who do you think you are….You are banned from JAMA for life. You will be sorry. Your school will be sorry. Your students will be sorry.”  Do JAMA editors have goon squads to make good on such threats?

After verbally assaulting Dr. Leo, Dr. DeAngelis is reported to have abused her JAMA position by calling Leo’s superiors at Lincoln Memorial University in Harrogate, Tenn., demanding that he be pressured into retracting the BMJ letter.

When asked by the Wall Street Journal reporter about the calls, DeAngelis derisively described Leo as “a nobody and a nothing.”

The JAMA editors’ outrageous conduct has ignited quite a firestorm of discontent among physicians : many JAMA subscribers identify themselves as one of the “nothings” for whom Dr. DeAngelis has shown such contempt.  Her arrogance touched off an outpouring of angry responses on the WSJ health blog with several respondents indicating they are canceling their JAMA subscriptions.  See, 77 comments (as of 2:41 AM Tuesday) to the WSJ:  [we include several comments below]

Medical journal editors are the gatekeepers of medical science. Their responsibility is to provide a forum for scientific debate without the threat of retribution, 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 shooting the messenger who detected a failure in their gatekeeping process.

The gist of the critique by Drs. Leo and Lacasse:
In an exchange of letters in JAMA (October 2008) the authors acknowledged their failure to do the analysis which revealed that there was no clinical or statistical difference between the drug and non-drug therapy. Given the serious adverse effects antidepressants pose, surely a risk/ benefit comparison would have been in order. Instead, Dr. Robert Robinson, the lead author of the study, actively promoted the unapproved, off-label use of antidepressants in the media as a preventive measure in stroke patients.

What’s more, he promoted the use of antidepressants for ALL stroke patients —whether or not they were even depressed! He told the Associated Press: "I hope I don’t have a stroke, but if I do, I would certainly want to be placed on an antidepressant."

He told USA Today : "I think every stroke patient who can tolerate an antidepressant should be given one to prevent depression." Dr. Robinson forgot to mention that his study found psychotherapy equally effective. The study sponsor, NIMH director, Thomas Insel MD, trivialized the psychotherapy results, stating, "We find most people would rather just take a pill."

Dr. Robinson failed to disclose (forgot?) that he had been a paid speaker for Forest Labs, maker of Lexapro.  The omission was noted by AHRP in October 2008  According to Dr. Leo, he relayed the financial conflict to JAMA at that time.

In their BMJ letter, Leo and Lacasse stated:

“The omission, however innocent or mistaken, is disturbing; neither the JAMA article nor subsequent media accounts noted that the lead author had served on the speaker’s bureau for the manufacturer of Lexapro. However, disclosure of the relationship would not have changed the troubling end result: A researcher with a history of being funded by SSRI makers completes a ‘gold-standard’ federally-funded study of post stroke SSRI use, which is published in one of the most prestigious medical journals in the world, and is given a forum in the national media to tell the general public that anyone who has had a stroke, whether or not they have been diagnosed with depression, should start a prophylactic regimen of Lexapro …even though non-medical approaches perform just as well.” [1]

Unable to find a factual error in the analysis by Leo and Lacasse, these JAMA editors resorted to ad hominem attacks, by calling Leo “a nobody and a nothing.”

Only after Drs. Leo and Lacasse’s letter had appeared in BMJ (March 5), did JAMA publish a letter from Dr. Robinson (March 11) in which he apologizes his failure to disclose receiving funds from Forest for “honoraria and expenses” which he blames on “errors of memory” while insisting the relationship had not influenced the study design or results.

The MIT-Knight Science Journalism Tracker , for one, doesn’t buy that excuse:  "Oh come on…scientists who expect to take the industry dollar and still have their work taken seriously have got to be able to do better than that."

Beyond Dr. Robinson’s lame excuse for a 10 month delay in disclosing his financial ties to the maker of the drug he reported about and promoted, is the larger issue: why did the JAMA editor fail to insist that the financial conflict of interest be disclosed to JAMA readers?

It appears that DeAngelis merely talks about conflicts of interest, but shows little interest in enforcing JAMA financial disclosure requirements. Three examples:

1. In April 2002, JAMA published a misleading report about a drug study that compared Zoloft to St. John’s wort and placebo. [3]

The reported results of this trial: "On the 2 primary outcome measures, neither sertraline [Zoloft] nor H perforatum [St John’s wort] was significantly different from placebo."   In other words this was a failed trial–both Zoloft and St John’s wort failed to beat placebo.  In fact, placebo-treated patients had a higher rate of improvement:  31.9% compared to 23.9% of St John’s-treated patients, and 24.8% of Zoloft-treated patients."

But such an acknowledgement would undercut the financial interests of all involved. So, the authors spun the conclusion by ignoring their own findings. Much like Dr. Robinson, et al, they pretended that one arm of the trial–in this case, Zoloft, which failed to demonstrate a benefit over placebo–was not part of the study. Their conclusion reported in JAMA and broadcast widely by the media was silent about the failure of Zoloft: "This study fails to support the efficacy of [St. John’s wort] in moderately severe major depression."  

Adding promotional momentum by further misrepresenting the study findings, David Kupfer MD , a prominent psychiatrist with copious ties to psychotropic drug manufacturers–including serving on the advisory board of Eli Lilly, Forest Labs, and Pfizer, maker of Zoloft–was selected by JAMA’s editor to write the accompanying editorial. [4] He disclosed no financial conflicts of interest.

2. On July 12, 2006, The Wall Street Journal reported that the authors of a JAMA report recommending the use of antidepressants in pregnant women, had undisclosed financial ties to antidepressant drug makers. The recommendation is particularly egregious inasmuch evidence links these drugs to birth defects, and an increased risk of suicide. 

3. On July 19, 2006, The Associated Press reported “JAMA Misled Again Over Industry Ties” this time an epidemiological study that linked migraine headaches and cardiovascular mortality. [5] None of the authors disclosed receiving funds from manufacturers of headache pills.  See also, http://www.ahrp.org/cms/content/view/296/149/ and critique by Dr. Daniel Carlat [6]

These “embarrassing” incidents led Dr. DeAngelis to update JAMA conflict of interest policy [7], to write an editorial [8] and to make numerous speeches about her determination to rein in conflicts of interest.  Her brass knuckle response to Jonathan Leo, however, shows that her determination is to conceal conflicts of interest from JAMA readers. Under her editorship, JAMA remains beholden to the “somethings and somebodies,” that is, the pharmaceutical-industry and industry funded opinion leaders who have dominated and almost completely perverted research reports into promotional drug marketing copy.

The Alliance for Human Research Protection believes that Drs. DeAngelis and Fontanarosa should publicly apologize to Dr. Leo and promptly resign from their positions. As those entrusted with the guardianship of the integrity of scientific medical journals-and by extension of medical research, their conduct sadly exemplifies a major flaw in the crumbling edifice of integrity and impartiality in medical research.
The AHRP will be filing a complaint with the Board of Directors of the American Medical Association, with the International Committee of Medical Journal Editors and the World Association of Medical Editors concerning the JAMA editors’ deviant conduct.

You can also read about the David and Goliath clash on Furious Seasons:

**And, this just in from Industry.BNET (Business Network), This Forest Labs’ Lexapro Flap Over JAMA Article Will Likely Be Examined by the Justice Department

1. Lacasse and Leo. Escitalopram, Problem-Solving Therapy, and Poststroke Depression. JAMA.2008; 300: 1757-1758.

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. Hypericum Study Group. "Effect of Hypericum perforatum (St John’s Wort) in Major Depressive Disorder:  A Randomized Controlled Trial," JAMA Vol. 287 No. 14, April 10, 2002, at: http://jama.ama-assn.org/issues/v287n14/rfull/joc11936.html.

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

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

6. Daniel J. Carlat, MD. Conflict of Interest in Psychiatry: How Much Disclosure Is Necessary? Psychiatric Times. Vol. 23 No. 13, November 1, 2006

7. JAMA Instructions for Authors. 2006. Available at: http://JAMA.ama-assh.org/misc/i4a.pdf.

8. Flanagin A, Fontanarosa PB, DeAngelis CD. Update on JAMA’s conflict of interest policy. JAMA. 2006;296:220-221.

MARCH 13, 2009
JAMA Editor Calls Critic a ‘Nobody and a Nothing’
By David Armstrong

Editors of The Journal of the American Medical Association, better known as JAMA, can be a little thin-skinned when it comes to outsiders taking issue with studies published in the prestigious medical journal.

Jonathan Leo, a professor of neuro-anatomy at tiny Lincoln Memorial University in Harrogate, Tenn., posted a letter on the Web site of the British Medical Journal this month criticizing a study that appeared in JAMA last spring. The study concerned the use of the anti-depressant Lexapro in stroke patients. In addition to identifying what he said was an important omission in the paper — that behavioral therapy worked just as well as the drug when compared head to head in the study — Leo also pointed out that the lead author had a financial relationship with Forest Laboratories, the maker of Lexapro, that was not disclosed in the study.

Leo says he received an angry call from JAMA executive deputy editor Phil Fontanarosa last week, shortly after Leo’s article was published on the BMJ Web site. “He said, ‘Who do you think you are,’ ” says Leo. “He then said, ‘You are banned from JAMA for life. You will be sorry. Your school will be sorry. Your students will be sorry.” Fontanarosa referred a call for comment to a JAMA spokeswoman, who said Leo’s retelling of the conversation was “inaccurate.”

“He did talk to the guy, but he said he didn’t threaten him,” the spokeswoman said. “It was something along the lines of not setting a good example for students. He didn’t say he would be banned. He 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.”

The call from Fontanarosa was followed up by ones from JAMA editor-in-chief Catherine DeAngelis to Leo’s superiors, Leo says. He said she asked his superiors to get him to retract his article in the BMJ. Leo says he decided to call DeAngelis directly to find out what, in particular, she might be objecting to. He said she was “very upset” but didn’t make specific complaints about the article.

In a conversation with us, DeAngelis was none too happy to be questioned about the dust-up with Leo.
“This guy is a nobody and a nothing” she said of Leo. “He is trying to make a name for himself. Please call me about something important.” She added that Leo “should be spending time with his students instead of doing this.”
When asked if she called his superiors and what she said to them, DeAngelis said “it is none of your business.” She added that she did not threaten Leo or anyone at the school.

Leo says he notified JAMA five months ago about the problem of the lead author not disclosing his financial relationship with Forest Labs. In this week’s edition of JAMA, a letter from the author, Robert Robinson, was published in which he acknowledged his financial relationship with Forest and apologized for the lack of disclosure.

“Although Forest Laboratories provided honoraria and expenses through their speakers’ bureau for Robinson, neither the design, analysis, or any of the expenses (including the cost of medications) of our study were supported by monies, materials, or any intellectual input from Forest Laboratories,” wrote Robinson, the head of the psychiatry department at the University of Iowa, and a co-author. “We sincerely regret this lack of transparency in our initial disclosures that resulted from these errors of memory.”

Robinson did not return a telephone message left at his office. Forest Labs said Robinson was a member of the company’s speaker’s bureau from 2004-2005. It would not say how much it paid him. In addition, Forest would not say if it has any research or other financial relationships with Robinson’s medical school.

There are 77 comments posted on the WSJ Health blog regarding this issue, below are but a handful:

2:41 am March 17, 2009    PEM MD wrote:
      I am a board-certified pediatrian, who cut my clinical teeth during residency reading widely respected peds textbooks co-edited by DeAngelis. I always looked up to her academic prowess, and today find I am dismayed, disillusioned, and yes, disgusted at the behavior of my fellow pediatric colleague. Especially in the name of professional ethics and integrity.
      Most pediatricians have no use for the AMA. We have the AAP and don’t need it. I felt the AMA was overrun by pharmaceutical interests 16 years ago — today it’s an absolute joke. After my first year in practice, I discontinued my membership. I was surprised when DeAngelis made the career move to edit JAMA(although the reported $500,000 salary may have a little to do with it!) But I am even more surprised to see her display such an elitist attitude in such a public forum as the WSJ. I never thought someone I looked up to as a true academic professional could be so painfully ignorant.

      Dr. DeAngelis needs to do two things.
      First, she needs to make a very public apology to Dr. Leo, and to her professional colleagues everywhere for her condescending and unprofessional remarks. Any one of us could have been a ‘nobody’ like Dr. Leo, in correclty questioning the integrity of the study in question.
      Second, then she absolutely needs to resign her ivory tower position at JAMA and regain some apparently much-needed humility.
      Finally: Thank you, Dr. Leo, for being a ’somebody’. Your students should be very proud to have you as a teacher and mentor.

1:24 pm March 16, 2009     
The AMA membership should be ashamed of their organisation’s leadership. This physician was simply drawing attention to something the AMA has railed against for a long time (i.e. pharma influence). AMA membership needs to ask several questions:
How many dollars does the AMA take in from the pharma industry each year? How many “educational activities” have been funded by the pharma industry?
How many healthcare industry marketing/advertising people have been the recipients of AMA-sponsored ski trips, spa days, extravagant dinners, rounds of golf, broadway shows, etc. This organisation is simply corrupt. The editors’ behaviour is an embarrassment to the entire organisation. If pharma companies were smart, they would steer clear of this inappropriate behaviour – and the AMA. And physicians should ask themselves if this is really the organisation that speaks on their behalf…

3:08 pm March 15, 2009 Anonymous wrote:
I am a general Internist practicing in a rural area of America, a HPSA also. I real the JAMA and the NEJM regularly as I try to keep up with my profession. Am I a nobody to the editorial board?
Such arrogance from the elites of academic and organised medicine does not bode well for the future of my profession. No sir, We are not nobodies, we are the reason you exist. And our patients, as opposed to the Drug and Insurance industries with which you have become too cozy are the reason our profession exists.
The sooner that you all understand this, and that includes the AMA itself the better for us all.

1:55 pm March 15, 2009 Dr. K. wrote:
The arrogance and hypocrisy of the JAMA editors, as well as the contempt in which they hold their readership, is clearly on display in the manner with which said editors inter-relate with big pharma. On the one hand, the editors publish poorly researched opinion pieces condemning pharma’s inflluence upon the “simpleton” and purportedly infinitely corruptible medical practitioner while at the same time these editors aggressively solicit high priced (approximately $7300 for a single full page ad color advertisement per issue) pharma advertizing for their publication. The assumption in this behavior is that the editors can resist the blandishments of $7300 per issue advertising while the morally bereft practitioner cannot be allowed the gift of a pen or note pad to corrupt his or her decisions. Dr. DeAngelis’ ill-advised comments have provided a clear window into the divide that has evolved between the witless “thought-leaders” in American medicine and those who truly provide care to the public. This arrogance may, in part, explain the dwindling membership in the AMA. It is long overdue to clean house at the editorial boards of JAMA, The New England Journal of Medicine and the equally dishonest Annals of Internal Medicine.

1:05 pm March 15, 2009 Bridget wrote:
Wow – I thought JAMA was a peer-reviewed and peer reviewed means that one is supposed to critically review the article in question for all assumptions and look for conflicts of interest. Constructive comments after publication are also considered part of the ’scientific method.’ If the editor resorted to ad hominem attacks, then that would indicate he/she might not have a credible response to the points being made. Additionally, I consider that unprofessional behavior – isn’t medicine one of the true professions like law and/or the military? The fact that a journal sponsored by a professional society would condone this type of unprofessional behavior tells me more about that profession and what it considers acceptable behavior, unless the board demonstrates through disciplinary action this is unacceptable.

12:53 pm March 15, 2009 transparency wrote:
Just wondering how the “somebody” invests her money.and if her investments relate to why she got so hot at this nobody. The somebody’s reaction is paradoxical if indeed Leo is a nobody saying nothing. The somebody should resign.

11:27 am March 15, 2009 skin surgeon wrote:
…congratulations to the nobody who got under the somebody’s skin. Questions should be asked of the U Pitt psche prof who gave the Fox Tv interview (referred to in nobody’s report at BMJ) favorable to the drug…when he is a recipient of significant funds from Forest.

7:04 pm March 13, 2009 James G. Knight MD wrote:
This is an example of some of the potential whos, hows and whys that call in to question the propriety of creating blanket practice guidelines/ evidence based medicine protocols!  Moreover, JAMA’s arrogance along with an apparent overwhelming sense of self-importance ought to be addressed directly by the AMA board of trustees. Coercion, character assassination and attempt to harm critics have NO place in the profession of medicine.

6:51 pm March 13, 2009 William Glasheen wrote:
I realize that there’s protocol in the peer review process. And there may be more civil and direct ways to go about what Jonathan Leo did. But the behavior of JAMA management was nothing short of appalling and embarrassing. Apologies are in order. And no, I will not hide my name.

6:07 pm March 13, 2009 AlgG wrote:
Are the doctors who read JAMA ‘nobodies’ also?

5:02 pm March 13, 2009 WSJ Fan wrote:
How arrogant does one have to be to refer to another person as a ‘nobody’? Appalling.

5:00 pm March 13, 2009 Shadows wrote:
A nobody? That makes me bristle. The extreme defensiveness makes me very suspicious.

4:38 pm March 13, 2009 Dr. Know wrote:
I am not going to say anything derogatory about JAMA or its editors. I do not feel like having a goon squad show up at my home or my place of work. Of course, that is NOT meant to imply that the good editors of JAMA are in the habit of sending out goon squads. I was simply making two completely unrelated comments. Hmmmmmmmmm.

4:08 pm March 13, 2009 observer wrote:
Congratulations to David Armstrong for having the courage to actually quote these people and report the news. Too often reporters try to smooth other these issues, rather than report them.

3:13 pm March 13, 2009 junlee wrote:
Appalling and despicable. JAMA needs more transparency and accountability. This sad episode gives additional pause to translating anything i read in jama into practice.  I am also concerned with JAMAs paper review policies. Unlike journals like BMJ they have a “closed” reviewer policy. This means that reviewer’s comments and conflicts of interest as a matter policy are not required to be communicated to the paper’s author. THe opacity of JAMA is very troubling. Bullies and thieves.

3:00 pm March 13, 2009 guests wrote:
Perhaps the journal should be renamed the Journal of the American Pharmaceutical Industry. For an editor to belittle a physician with ad hominem attacks and yet ignore the substance of his apparently accurate concerns is unconscionable. I am canceling my membership to this awful organization