Monday, March 23, 2009

JAMA Editors Need to Come Down off their High Horse--and 'Fess Up

The story about JAMA has been brewing for some days now, and every time I go to write about it, a new chapter emerges. Let me try to walk you through what's happened so far.

The story goes back to this article (note: subscription may be required to access some JAMA links):

Dr. Robert Robertson (Univ. of Iowa) and colleagues studied two treatments for patients who had just had a stroke (and who were therefore known to be at high risk for depression)--counseling and escitolapram (Lexapro). As the study showed that Lexapro was superior to placebo, Robinson gave a number of interviews and made several statements urging that all patients post-stroke be considered for drug therapy.

Enter Jonathan Leo and Jeffrey Lacasse, a couple of PhD's who had previously published very nice work about the excesses of the serotonin theory of depression. They first published a letter in JAMA pointing out a problem in interpreting the original study:

In reply Robinson admitted their main point:

That is, while the investigators had shown that the drug treatment was better than placebo, they did not show that it was better than counseling. On review of the data Robinson admitted that the drug and counseling showed no difference. This of course was hardly the pro-drug message that had been put out through the media.

Leo and Lacasse then dug a bit deeper and wondered whether Robinson had received financial support from Lexapro's makers. No such conflict had been revealed in the original JAMA paper, but it took them a few nanoseconds on the internet to discover numerous financial links between Robinson and Forest Labs. Leo notified JAMA of this omission in the stated conflicts.

After time had gone by and no response had been received from JAMA, Leo and Lacasse decided to write a letter to the "Rapid Response" section of BMJ describing the incident and raising their concerns (in notably temperate language that did not accuse JAMA of anything bad and that indeed recognized JAMA for its strong editorial stance in favor of disclosure and avoidance of conflicts). Leo later reported that they had sent JAMA copies of their letter to BMJ and generally had checked with JAMA about the progress of the matter, without initially receiving any reply. The "Rapid Response" appeared in BMJ on March 5:

And then the stuff started to hit the fan.

The same week, JAMA published a letter from Robinson admitting that there had been incomplete disclosure of conflicts, and citing "erroneous recollection" as the excuse:

We next heard about the fallout from the BMJ letter in the Wall Street Journal health blog, in a posting by their veteran reporter, David Armstrong:

JAMA told Armstrong that the appearance of the letter from Robinson in that particular issue had been planned for some time previous, and that JAMA felt it a major violation of good editorial practice that Leo and Lacasse had gone to another journal to air their charges instead of letting JAMA complete its internal process. Armstrong reported further that JAMA deputy editor Phil Fontanarosa had called Leo and basically threatened him with permanent banishment from ever having an article published in JAMA. Editor Catherine DeAngelis then called Leo's dean to complain about his unprofessional behavior. Things got really juicy, as far as journalism is concerned, when DeAngelis told Armstrong that he should not waste time on this story because Leo is "a nobody and a nothing."

As this story gained legs in the blogosphere (though the regular media seems to have been pretty quiet about the whole thing, not surprisingly--who really cares about a spat between journal editors and academics who wrote a letter?), JAMA apparently felt mistreated, and so this rather odd editorial appeared on its website:

In the editorial the editors basically deny Armstrong's account of their phone conversations and deny that anyone was threatened. DeAngelis said flat out that she never said that Leo was "a nobody and a nothing"--we are waiting for the next WSJ blog to see what Armstrong thinks about being called a liar. The main point of the editorial is that JAMA has a perfectly good internal system for dealing with allegations of incomplete disclosure of conflicts. Leo and Lacasse, once they notified JAMA, should have sat by quietly and let that process work. Above all else they had no business writing to BMJ, talking to any of the media, or in any way raising their voices. Doing so constituted a serious breach of confidentiality and was therefore something to be complained of to Leo's dean, for example.

The editorial has given rise to rebukes from other present and former journal editors:

In turn, Leo has put his own account of the timeline of events on line to compare with the allegations in the JAMA editorial:

Comment: In preparing their editorial response to the WSJ blog post, the editors seem to have consulted the well-known PR firm, When You're in a Hole, Grab a Shovel and Dig Yourself In Deeper. They started out in a pretty bad position. They appeared to be throwing around their weight and power to intimidate a couple of relatively minor academics at some minor institutions. Let's be really clear what it means to call up a professor's dean to complain--you are saying to the world, "I have no reasoned arguments or facts to offer against what this fellow has been saying. Instead I have power and muscle, and I will use that instead of reasoned argument, to show the guy that I am not the sort of person he can mess with." (To his credit the Dean seems to be backing up Leo.) Anyone who says this is really about professional standards and confidentiality is blowing smoke; it's about power.

The main proposal of the editorial, that authors should let JAMA carry out its supposedly infallible investigation process and impose a gag on themselves for however long JAMA chooses to carry it on, has correctly earned the hoots of other editors and academics, who refer instead to the value of academic freedom and freedom of speech.

It is also unfortunate that the editors have undone so much of their former good work. When you take a strong editorial stand against commercial conflicts of interest, you set for yourself a high standard. You proclaim to the world that you anticipate being brought to task if you fall from that standard in the future. If you act later on as if you deserve a free pass for having said all those nice things previously, and so expect that no one will beat you up if you later fall off your pedestal, you show that you never really had committed yourself to that high standard in the first place. No one ever recommended a life of virtue because it's easy.

I can relate to what Leo and Lacasse are going through because of the treatment I received at the hands of JAMA's editors a few years ago when I was doing the research for HOOKED. I became curious about the background to the CLASS study. Readers will recall that that study was notorious for claiming that Celebrex was highly effective in preventing serious gastrointestinal bleeds, when it was later disclosed that the authors had reported only on the first six months of data, and ignored the second six months of the study when the apparent benefit attributable to Celebrex was reversed. On the face of it, that sort of manipulation of the data amounts to presumptive research fraud. I was curious as to why JAMA, on finding out that these data were withheld (admitted by DeAngelis in an interview with the Washington Post), did not demand that the article be retracted.

I e-mailed Dr. DeAngelis for an explanation and, upon receiving no answer that I was aware of, I next tried contacting another member of the editorial board, Dr. Drummond Rennie. That brought a very angry e-mail from Dr. DeAngelis, noting (correctly) that she had indeed replied but that I had missed her e-mail, and that she was now accusing me of violating JAMA policy by going behind her back to quiz other editors and apparently trying to sow dissent among the editorial board. I apologized for having missed her e-mail and explained once again that all I wanted was some information and had no desire to violate board policies. The only explanation regarding CLASS that I received (and that I included in the endnotes in HOOKED) was that all such decisions are private and confidential within the editorial board.

No one, as I recall, told me that I was banned from JAMA. But the tone of Dr. DeAngelis's e-mail gave me the very strong impression that I should not be surprised if none of the papers I might submit to that journal in the future ever found their way into print.

I cannot help but note now that the full story on CLASS has never yet been revealed by JAMA and despite what would appear to be blatant research fraud, the original study has never been retracted--nor has any explanation been given for the non-retraction. (By contrast, JAMA has called for Leo and Lacasse to retract their BMJ letter, without offering any substantive reason why it is flawed.)

Accordingly my advice to JAMA's editors would be as follows:
  1. Get off your high horse and stop acting like demigods.
  2. Stop pretending as if JAMA's internal editorial policies are somehow sacrosanct and unchallengeable.
  3. Set the record straight on CLASS, finally.
  4. Stop beating up on Leo and Lacasse. Be big and apologize.


Anonymous said...

Well put.

InformaticsMD said...

At the WSJ here Prof. Leo wrote:

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

I correct this statement as follows:

The claim that JAMA can control the flow of information in the public record should be considered ABSURD by bioethicists and other academics who study the process of medical research and publication

The public record is, in fact, public. By definition nobody (except perhaps totalitarians) can "control" the dissemination of the public record.

I would like to know who was behind such tortured reasoning and hysterical editorializing. I can't imagine an attorney would issue such an argument.

Anonymous said...

Here here, come on Catherine pull your head out of you know what.

I think this bizarro world scenario is further evidence that the 'older generation' has not figured out that in the modern world of the internet, everything is transparent, and you can't get away with this crap anymore.

Matthew Cline said...

... consulted the well-known PR firm, When You're in a Hole, Grab a Shovel and Dig Yourself In Deeper.

Boy, they must be raking in money hand-over-fist!

Marilyn Mann said...

MARCH 28, 2009

Medical Group Seeks Probe of Its Journal

The American Medical Association said it has asked an oversight committee to investigate charges that the top editors of its well-known medical journal threatened a researcher who publicly faulted a study in the publication.

The move by the AMA follows criticism of the actions of top editors at the Journal of the American Medical Association, known as JAMA.

The AMA, in a statement, said JAMA operates with editorial independence. However, the association said it has "formally referred" the matter to a seven-member Journal Oversight Committee, comprised primarily of medical academics, to investigate the actions of JAMA editors. The oversight committee is a standing body that has editorial responsibility for JAMA, including evaluating the performance of the editor in chief.

A Tennessee researcher, Jonathan Leo, says top JAMA editors threatened him and his dean after he published an online letter earlier this month in the British journal BMJ that criticized how results were reported in a JAMA study last year that looked at the use of the antidepressant Lexapro in stroke victims. Dr. Leo also said JAMA didn't disclose the author of the study's financial relationship with Lexapro's maker, Forest Laboratories Inc.

Dr. Leo is a professor of neuroanatomy at Lincoln Memorial University in Harrogate, Tenn. Forest acknowledged that it had paid the author for speeches, but said his Lexapro research was independent.

Dr. Leo said JAMA editors demanded that he retract the letter. In addition, he says JAMA's executive deputy editor, Phil Fontanarosa, told him, "You are banned from JAMA for life. You will be sorry." Dr. Fontanarosa, through a spokeswoman, has said Dr. Leo's version of the conversation is "inaccurate."

Dr. Leo's dean, Ray Stowers, says JAMA Editor in Chief Catherine DeAngelis threatened in a telephone conversation earlier this month that she would "ruin the reputation of our medical school" if he didn't force Dr. Leo to retract the BMJ letter and stop talking to the media. Dr. DeAngelis, through a spokeswoman, has denied threatening the dean.

The AMA statement said it takes the concerns raised over the Dr. Leo matter "very seriously." It said the AMA board will "give careful consideration to whatever is reported to it" by the oversight committee.

The AMA action comes a day after a nonprofit group that monitors industry links to medical research called for the suspension of the JAMA editors, and an investigation into their treatment of Dr. Leo.

In an editorial posted on the JAMA Web site last week, Drs. DeAngelis and Fontanarosa responded to the controversy over their handling of Dr. Leo's criticisms by accusing the researcher of a "serious breach of confidentiality" by writing about the problems with the JAMA study while the medical journal was still investigating the matter.

Dr. Leo said he identified the undisclosed conflict of interest through a quick Internet search. The editors said that, going forward, anyone complaining of an author failing to report a conflict of interest will "be specifically informed that he/she should not reveal this information to third parties or the media while an investigation is under way."

Anonymous said...

JAMA's behavior here is one giant mark against the idea that any one organization can be self-policing. Efforts to reform practices in CME and other ethical conundrua will come to nothing if everyone is relying on _one_ group to be the arbiter of purity.

Anonymous said...

You may be interested to note that the March 20 JAMA editorial "Conflicts over conflicts of interest" to which you refer has now been expunged from all electronic databases without notice or retraction. As far as Medline and ISI and JAMA is concerned, it never existed. Thoughts?

Private health insurance said...

I am very impressed on how you presented both sides of the story. But yes, I have to agree that the JAMA editors should go down their high horse and approach this issue professionally.