About a month and a half ago, I happened to be fortunate enough to be able to swing the time to attend a symposium in which Brian Deer (whom anyone reading this blog lately is well familiar with) spoke. It was an opportune time, coming as it did around the time when he had just published his new blockbuster story about how Andrew Wakefield, architect of the MMR vaccine scare in the U.K., had apparently falsified data for his infamous 1998 Lancet paper that started it all. The symposium was entitled Science, the Media and Responsibility for Child Health: Lessons Learned from the MMR Vaccine, and its was (or so I thought) the role of the press and journals in perpetrating or preventing such scandals and fueling vaccine scares. Sharing the stage with him was Catherine DeAngelis, the editor-in-chief of the Journal of the American Medical Association. I have to admit that I was puzzled by the combination. Deer gave a really entertaining talk about how he first became interested in the Andrew Wakefield case, how he pursued it, and, finally, about the role of irresponsible journalists in promoting the MMR scare based on the truly bad science pushed by Wakefield. Even though it had been raining and I was nearly soaked from my walk from my car to the lecture hall, I enjoyed Deer’s talk immensely and even got to speak to him briefly after it was over, before he was whisked away to various social functions. I was also flattered to learn that Deer does from time to time check out this blog.
Then it was Dr. DeAngelis’ turn to speak, and it was clear that the two talks really had little or nothing to do with each other. Hers was clearly a generic, canned talk that didn’t even reference pediatric issues for the most part. That doesn’t mean it wasn’t a good talk, but it was clear that she hadn’t even made even a slight effort to tailor her talk to her audience.
She started out rather amusingly, displaying this conflict of interest slide (photo taken with my iPhone, of course):
I was half-tempted to construct a slide like that for myself, except that I prefer to joke that no pharmaceutical company has found my research sufficiently interesting or promising to want to fund it.
Yes, Dr. DeAngelis played her tough-but-lovable Italian mother schtick to a tee, charming the audience and leading it along with her as she discussed conflicts of interest (COIs) in the medical literature, particularly undisclosed COIs. During her talk, she discussed several examples of COIs, disclosed and undisclosed, by authors submitting manuscripts to JAMA and how she dealt with them forthrightly and honestly.
I remember one anecdote she told in particular about how she fought the influence of big pharma in JAMA because it was the most amusing–and, well, memorable–of the lot. In brief, a story was scheduled to be published in JAMA that reported favorable results for a drug made by a certain pharmaceutical company. Because the company had been involved with the study, it knew the planned publication date of the manuscript. To take advantage of the favorable study, a representative of the pharmaceutical company apparently had been pestering the ad department of JAMA to sell it advertising space in the same issue in which the article was to appear. At this point DeAngelis emphasized that it was JAMA policy that no ads would be sold to a pharmaceutical company whose product was being featured in a study published in JAMA in the same issue in which that study was published. It sounded like quite the reasonable policy, a sensible means of preventing pharmaceutical companies from too blatantly capitalizing on favorable studies and preventing JAMA from being too tempted to jack up its rates and solicit pharmaceutical companies for ads in issues where favorable articles were to appear. Apparently this particular pharmaceutical company’s representatives were particularly persistent and annoying; DeAngelis described a call from one of JAMA’s advertising sales staff begging her to let him sell the ad and telling her that it was a lot of money for the journal. DeAngelis told him the company could have as many ads as it wanted, just not in that issue, to which the salesman responded that the company was interested only in that issue. DeAngelis then slyly grinned and related to the audience how she told him, in essence, “OK, you can run the ad in that issue.” She then told the audience with a grin that immediately after that call she called the publisher and changed the publication date of the study to a different date. Whether her talk was canned or not, I had to admit that she was successfully representing herself as a defender of the integrity of medical publishing, and she even had me believing it.
Then I heard about how JAMA deals with criticism when it screws up over–yes, you’ve got it–undisclosed conflicts of interest (COIs). Then I heard how Dr. DeAngelis called someone who dared to call JAMA out for failure to police its COI disclosure policies adequately a “nothing and a nobody” when questioned about reports that she and another of her editors had tried to intimidate the letter writer and his dean. If the story is true, apparently Dr. DeAngelis’ schtick was just that–schtick, at least when it comes to her personally.
Dr. Ray Poses at Health Care Renewal has a detailed timeline of what happened, and there’s more about the story here, but the first media report of this brouhaha came out of the Wall Street Journal Health blog about a week and a half ago:
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.”
In other words, Dr. Fontanorosa is basically accusing Dr. Leo of lying. Given what happened later, somehow I have my doubts about Fontanarosa’s denial. Maybe it was all a misunderstanding, but I tend to doubt it. At the very least it’s clear that Dr. Fontanorosa leaned on Dr. Leo to some extent, whether he actually threatened to ban him from JAMA for life or not. In any case, Dr. Leo had no reason to lie and every reason to shut up, given what happened next:
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.
Which sure sounds to me as though things did go down exactly as described by Leo. Moreover, after having seen Dr. DeAngelis in person bragging about telling off various pharmaceutical executives and representatives, I can totally picture her bullying some hapless dean at a tiny school in Tennessee. I also do not recall her addressing this issue in her talk, although I hadn’t heard of it at the time, making it possible that I simply did not recall. Given how Dr. DeAngelis painted herself and her journal in little but the most glowing terms, my guess is that I would have remembered it if she had given an honest, self-examining appraisal.
At this point, let’s backtrack a moment. Basically, what sparked this whole brouhaha began nearly a year ago. In 2008, Dr. Robert Robinson published study reporting the results of a randomized clinical trial comparing placebo, cognitive therapy (specifically, learning therapy), and escitalopram (Lexapro, Forest Laboratories) head to head as strategies to prevent depression in patients who have suffered from strokes. Patients who received placebo were found to have more depressive episodes (11 major, 2 minor cases, 22.4%) than patients who received Lexapro (3 major, 2 minor, 8.5%) or who received cognitive therapy (5 major, 2 minor, 11.9%). In the disclosure section, Dr. Robinson reported having served as a consultant to Hamilton Pharmaceutical Company and Avanir Pharmaceutical Company. However, somehow he neglected to report that he had been on the speakers’ bureau for Forest Laboratories, the manufacturer of Lexapro. It is possible, even likely, that there was no malicious or deceptive intent there; it is possible that Dr. Robinson simply forgot. However, it does look darned peculiar, given that he was reporting the results of a study of a drug manufactured by Forest. In fact, in retrospect, this lapse appears even more peculiar and suspicious, given what happened next.
In October 2008, Drs. Jonathan Leo and Jeffrey Lacasse published a letter in JAMA asking whether Robinson had had done an analysis directly comparing problem-solving therapy and Lexapro. Robinson responded that there were no statistically significant differences between the Lexapro and the learning therapy groups, meaning that cognitive therapy did as well as drug therapy–a result of the study that was not–shall we say?–being strongly emphasized. At the time, Dr. Leo also reported Dr. Robinson’s undisclosed COI, apparently privately to JAMA editors. Nothing happened, at least nothing that Dr. Leo was made aware of; so Dr. Leo decided he needed to get the message out another way. Consequently, last month Drs. Leo and Lacasse published a letter entitled Clinical Trials of Therapy versus Medication: Even in a Tie, Medication wins in the BMJ rapid response section in which they pointed out the flaws in the JAMA study and the failure of reporting of significant COIs:
Journals such as JAMA require authors to publish their conflicts of interest at the end of their studies. In JAMA’s conflict of interest policy they state that authors should include potential conflicts from the past five years. The study in question did list several conflicts, but the list did not include Forest pharmaceuticals, the manufacturer of Lexapro. During a subsequent internet search we were surprised to learn that four years previously the lead author had been listed on the speaker’s bureau for Forest.5 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.
In addition to the lead author having an undisclosed conflict with the makers of Lexapro, a simple internet search also revealed that the expert who was subsequently asked to interpret the study for two different news outlets had been receiving money…in the form of research grants from Forest since 2004, yet neither outlet reported his conflict. It is certainly true that having a conflict of interest does not automatically negate someone’s view – even someone with a large conflict-of-interest can be correct. Yet, when facts emerge demonstrating that crucially important information was selectively omitted by researchers with conflicts-of-interests, it is hard to not question whether the conflict was the root of the problem.
This letter was what provoked the nasty reaction from two head honchos of the JAMA editorial staff. But that’s not the weird part. If that were it, perhaps one could simply dismiss the reports of threats and Dr. DeAngelis’s rather nasty comment about Dr. Leo to a WSJ reporter interviewing her seeking a statement as perhaps an anomaly, where, embarrassed by their inaction they had lost their cool momentarily and lashed out. Unfortunately, that appears not to be the case, as four days ago JAMA then had to go and publish a very disturbing editorial electronically that was, in essence, a long apologetic for its behavior, behavior that would have been pathetically easy to take care of just by sucking it up, saying “we screwed up,” publishing a correction, and apologizing for the mistake. After all, as Dr. DeAngelis pointed out in her talk, JAMA receives around 6,000 manuscript submissions a year; it would not be surprising if the editorial staff screwed up occasionally. They don’t have the resources to investigate every published submission to verify that the authors disclosed everything.
If that’s what JAMA had done, it would have been virtually the end of the story. Given Dr. DeAngelis’ history of going to war against big pharma influence in her journal, she would have likely been rapidly forgiven. Instead, JAMA appeared to do nothing for five months (more on that later) and then only responded when Dr. Leo wrote his letter to the BMJ. Going on to show that stonewalling and lashing out against critics virtually always fails to do anything other than dig the proverbial hole deeper and deeper, Drs. DeAngelis and Fontanarosa wrote an editorial in JAMA that is the very picture of hubris and Orwellian language, as shown by this excerpt:
As a result of these recent events we are making the following modifications to our already rigorous approach for investigations into allegations of unreported potential conflicts of interest. JAMA will require that the individual bringing the allegations provide a written detailed explanation of the unreported conflicts of interest and provide documentation to support the allegation. The person bringing the allegation will be specifically informed that he/she should not reveal this information to third parties or the media while the investigation is under way, will be informed about progress of the investigation, upon request, as appropriate, and will be notified when the investigation is completed. In addition, once the investigation into unreported conflicts of interest is completed and the letter of explanation and the correction are finalized, those documents will be immediately posted online and linked from the article, and then subsequently published in the print journal.
The duty to disclose and report potential conflicts of interest hinges on trust and patience, and a common bond among authors, editors, and readers recognizing that reporting the best available biomedical science matters most. Pressures to publish rapidly, reports in the news media, and comments on blogs and advocacy sites cannot overwhelm the process of thorough and fair investigation when reputations are at stake. A rush to judgment may spark heat and controversy, but rarely sheds light or advances medical discourse.
In other words, let us decide if we’ve screwed up about an undisclosed COI and do please shut up about it while we’re taking our time deciding. In a breathtakingly clueless policy statement, DeAngelis and Fontanarosa declared that from now on the above statement is JAMA’s policy. Unless complainants sign some sort of confidentiality agreement, I can’t see how this policy could possibly work; that is, without the implicit threat that Drs. DeAngelis and Fontanarosa will blackball any academic physician who complains and then doesn’t stay silent about it, as they apparently threatened to do to Dr. Leo. I can see the importance of confidentiality in the event of a true whistle blowing scenario, but this is different. In fact, what’s really amazing is that, as Dr. Leo reported, Dr. Robinson’s ties with Forest Laboratories were easily discoverable on the web and would have taken five minutes to verify. Apparently the crack investigative team at JAMA has never heard of Google or Yahoo!; certainly taking five months raises my suspicion that Dr. DeAngelis had no intention of doing anything–that is, until she was stung by that “rude” Dr. Leo airing JAMA’s dirty laundry outside of the “family.” Ironically, apparently by the end of January, JAMA had in its hands a letter from Dr. Robinson acknowledging the unreported COI but never informed Dr. Leo, leaving him to think that nothing was being done. Had Dr. DeAngelis or Fontanarosa simply e-mailed him saying that a letter would be published acknowledging the COI, Dr. Leo wouldn’t have been left assuming that nothing was happening
Even worse, DeAngelis and Fontanarosa, while whining about the supposed violation of their “confidential” investigation processes, published in their editorial an excerpt of Dr. Leo’s e-mail to Dr. DeAngelis explaining why he went public at BMJ over this issue! The only way that this would be acceptable behavior is if Dr. Leo explicitly gave them permission to publish his e-mails in their editorial, something I sincerely doubt that he did. I wonder how Drs. DeAngelis and Fontanorosa would have reacted if Dr. Leo had included part of an e-mail exchange with them in his letter to BMJ. Pot. Kettle. Black. That’s what I say.
Even worse still, DeAngelis and Fontanarosa wrote:
Although we appreciated Leo alerting us to the potential omission of some financial disclosure information by Robinson, we maintain that his actions were inappropriate in contacting the media and by his posting on the BMJ Web site prior to publication of the correction and letter of apology from Robinson. 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 interest and cases of duplicate publication.
Our tone in these interactions was strong and emphatic, reflecting just how seriously we take the responsibility to ensure a fair process of investigation and above all, to protect the integrity of science and the reputation of JAMA.We regret if anyone involved in these communications interpreted our intentions in any other way..
In other words, we’re sorry if you think our trying to make trouble for Dr. Leo by going to his bosses and making threats makes us look bad, but you clearly don’t know that we’re on the side of right because that mean and nasty Dr. Leo dared to tattle on us to the press. In addition, because Dr. Leo complained outside the JAMA “family,” DeAngelis apparently has decided to ban him from ever publishing in JAMA again. It’s all there, right in the editorial! Here is the relevant quote:
Leo also was informed that, if his actions represented his apparent lack of confidence in and regard for JAMA, he certainly should not plan to submit future manuscripts or letters for publication.
Do intimidation and retribution get any more naked than that? Does it get more petty and vindictive than that? Although it probably matters little to Dr. Leo at this point, the message to potential authors who might want to publish in JAMA sometday is loud, clear, and unambiguous: Toe the line by not publicly criticizing or complaining about us, or we ban you for life.
But that’s not all. By what was written in this editorial it appears that DeAngelis and Fontanarosa are in essence admitting their attempt to intimidate Dr. Leo’s dean. Think of it. The the editor-and-chief of one of the most prestigious medical journals in the world used her clout by calling Dr. Leo’s boss and trying to bully him into shutting Dr. Leo up for her or otherwise punishing him. I can picture the conversation just from what was written above: “You know, Dean, JAMA could make your medical school look really bad, and no one wants that, do they? So you might want to think about reining in that Leo guy of yours, if you know what I mean.” Or perhaps something along the lines of, “Nice university ya got there. Be a shame if something bad happened to its reputation.” And before someone takes me to task for implying a comparison to the mafia, I would point out that Dr. DeAngelis herself revels in such stereotypes. Indeed a New York Times article last year reported that she pretends that she has an Uncle Guido who will go around and break legs for her and that she has postcards on her office door of statues of guys named Guido. Sauce for the goose.
In fact, I can’t remember ever having seen such a blatant display of intimidation openly written in an editorial in a peer-reviewed journal. But if you want the piÃ¨ce de rÃ©sistance that shows JAMA’s utter cluelessness about how badly its editors were shooting themselves in the foot, look no further than DeAngelis and Fontanarosa’s having likened Dr. Leo’s letter to BMJ bringing to light deficiencies in a manuscript published by JAMA and JAMA’s five month failure to act on an an undisclosed COI to much more serious breaches of academic conduct, such as cases of duplicate publication (which is generally considered academic fraud) and undisclosed COI. I find it utterly inexcusable that the editors of JAMA would equate writing a letter pointing out its failing in a simple COI disclosure issue to academic fraud. It’s truly breathtaking in its clueless arrogance.
Dr. Leo has written a response to the JAMA editorial that is so spot on that I urge you to read it in its entirety. In it, he makes some of the same points that I’ve just made, and he provides links to the publicly available information on the web showing Dr. Robinson’s undisclosed COIs, but the money quote is this:
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.
Now that’s going to leave a mark.
I must admit that Dr. DeAngelis sure puts on a good talk that represents her and JAMA as champions against big pharma, fighting against any hint of undue influence by industry on what is published in JAMA. This most recent kerfuffle aside, she and JAMA are to be congratulated for their efforts in those areas. However, Dr. DeAngelis’s self-righteous pugnaciousness, which serves her well in dealing with the depredations of big pharma trying to gain undue influence in her journal, does not serve her or JAMA well when she apparently can’t distinguish such depredations from the concerns of an honest physician who became frustrated when he saw no apparent action on his bringing an undisclosed COI to her attention. Such a problem should have been trivial to deal with but instead, by all reports, Drs. DeAngelis and Fontanarosa proceeded to make a bad situation worse by going full mental jacket on Dr. Leo and his dean, blustering and bullying to get their way. When they couldn’t get their way, they then, in an astonishingly tin-eared response, decided to codify their lapse in judgment into official JAMA policy in a petulant editorial that was also designed to slime Dr. Leo by implying that his actions were akin to academic fraud or a failure to disclose a COI. I can’t overemphasize how wrong-headed this is.
My impression from having seen Dr. DeAngelis speak last month and on one other occasion is that she very much revels in her reputation and self-image as an iconoclast and maverick, the tough little Italian woman standing up for academic integrity against big pharma, so much so that apparently she can’t imagine herself ever being in the wrong on an issue involving COI disclosure. At the talk, she bragged that she had been educated by what she humorously characterized as the “Sisters of No Mercy,” and some of her previous positions, such as stating that she wants it to be a crime for physicians to accept gifts from drug companies seem to support her “show no mercy” image. Unfortunately, her “no mercy” approach doesn’t seem to have an off switch or to be able to reliably distinguish ally from enemy. That Dr. DeAngelis has played a major role in reining in the influence of big pharma in academic medical publishing is definitely a good thing, but she’s lost her way on this issue. Big time.
Come to think of it, behavior by the editors of “old-fashioned” academic journals such as that of Dr. DeAngelis is one reason why the open access movement is gaining steam. She clearly just doesn’t get it that the world has changed and that her new policy will simply guarantee that more complaints about JAMA will be made public through letters to other journals, contacts with reporters, or in medical blogs like this one. Journal editors can no longer control the flow of information (if they ever truly could); the Internet has changed everything.
In the meantime, I guess that if either Dr. DeAngelis or Dr. Fontanarosa ever find out who I am, I’m in a world of hurt academically, given their history of naked intimidation (which is why I am linking to my disclaimer here and pointing out that these are my and my opinions alone–not those of my cancer center, university, practice group, or anyone else–and pointing out that I stayed up past midnight last night to write this little bit of Insolence on my own time). At the very least, I guess I won’t ever be publishing in JAMA during my career, assuming that someone from JAMA doesn’t call my department chairman or cancer center director, in which case I can only hope they have the intestinal fortitude that Dr. Leo’s dean demonstrated in refusing to knuckle under. Not that I’m sure I’d want to publish in JAMA anymore unless and until I see an apology to Drs. Leo and Lacasse written by Drs. DeAngelis and Fontanarosa.
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