March 12, 2009JAMA Editor In Chief "Upset" At Researcher For Pushing Conflict Disclosure At JournalAn ironic and odd tale has come to my attention, one involving the editor-in-chief of JAMA, Catherine DeAngelis, researchers who failed to report conflicts of interest to the journal on a Lexapro study, and DeAngelis calling one other researcher, who brought the unreported conflict to the journal's attention, by phone to chew him out. What's ironic is that DeAngelis has made much hay out of her efforts to eliminate conflicts of interest from medical studies and yet there she was picking up the phone to call Jonathan Leo, an associate professor of neuroanatomy at Lincoln Memorial University in Tennessee, and give him hell when she should have been thanking him for identifying an unreported conflict of interest that got past reviewers and editors at JAMA. That's as odd as odd gets. I'll come back to DeAngelis in a bit, because the science piece of this story is almost as odd. I contacted JAMA to interview DeAngelis, but did not get a reply from her. The story begins last May when JAMA published a study by Robert Robinson, a psychiatry professor at the University of Iowa, and others. Their work was funded by NIMH. In the study, the researchers examined the effects of Lexapro, Problem Solving Therapy and placebo on depression in post-stroke patients without depression for one year. The results were 8.5 percent of Lexapro patients developed depression, 11.9 percent of the PST patients developed depression and 22.4 percent of placebo patients developed depression. Oddly, the authors didn't address the statistical significance of the small difference between Lexapro and psychotherapy on post-stroke depression, even though they did examine the significance between medication and placebo. Remember that point. Soon after the study appeared, the benefits of post-stroke treatment with Lexapro were being touted in the press. "Study: Antidepressants help stroke victims," declared USA Today. Robinson told the paper, "I think every stroke patient who can tolerate an antidepressant should be given one to prevent depression." Tom Insel, NIMH director, pretty much pooh-poohed the psychotherapy results, telling the paper, "We find most people would rather just take a pill." Robinson told the AP this: "I hope I don't have a stroke, but if I do, I would certainly want to be placed on an antidepressant." Robinson's claims are significant because he is claiming that all stroke patients should be placed on an anti-depressant--regardless of whether or not they have depression--as a preventative measure, but he made no mention whatsoever of PST as being a similarly effective. Approximately 780,000 Americans have a stroke each year. So that kind of omission represents something of marketing pimpery for Lexapro's maker, Forest Labs, especially since PST had been shown to be as effective as Lexapro and that the difference between the two modalities didn't seem to be statistically or clinically significant. Last October, JAMA published a letter by Leo and Jeffrey Lacasse, an assistant professor of social work at Arizona State University, challenging the omission: "The reported incidence data showed that the rate of depression was approximately the same in both escitalopram (8.5%) and problem-solving therapy (11.9%) groups. This difference does not appear to be either clinically or statistically significant. The authors could enhance the value of their research by providing this additional piece of analysis." Robinson and his colleagues replied in the same issue of JAMA. I don't have access to the full text of their response, so here's how Leo and Lacasse characterize their response: "[A]cknowledgement from the original authors that indeed the difference between therapy and medication was not statistically significant." So, in essence, PST and Lexapro had the same effect in post-stroke depression treatment, even though there are vast differences in the side effect profiles of psychotherapy and SSRIs and in the corporate interests regarding Lexapro and psychotherapy. But that wasn't the story the media and Robinson told the public. Given how well known are problems such as withdrawal from anti-depressants, suicidality induction and, as recently revealed by the Nurse's Health Study, sudden cardiac death in women connected to anti-depressant use, you'd think the media and Robinson might want to give psychotherapy a wee bit of credit, but no. In the May 2008 study, Robinson reported receiving monies from Hamilton Pharmaceutical Company (now a subsidiary of Neuren Pharmaceuticals), Avanir, Lubeck and Pfizer. Not long after the October 2008 letter exchange, Leo and Lacasse began examining Robinson's recent publications and found that in other publications Robinson had reported receiving monies from Forest Labs--which of course makes Lexapro. Leo told me in an interview yesterday that he then made JAMA aware of the incomplete disclosure by Robinson in November 2008. On March 5, Leo and Lacasse published a piece on the website of the British Medical Journal, detailing this odd affair. Leo told me that the same evening he was contacted by phone by an editor at JAMA (he doesn't recall their identity) and was told that JAMA wasn't happy that he and Lacasse had written about Robinson's failure to report a major conflict. Leo says that the editor didn't tell him why they were upset with the BMJ piece and didn't dispute any of the facts in the piece. That's when things got even more interesting. The next day, March 6, Leo got a phone call from Catherine DeAngelis, the editor-in-chief of JAMA. Leo told me that he had never heard from DeAngelis before. He didn't want to discuss the details of what she said, since DeAngelis is quite important in medical circles--or so say my sources--and she wouldn't be a good person to have angry at you. Leo told me that DeAngelis was "upset" and that her conversation with him left him "quaking in my boots." Leo told me that DeAngelis didn't dispute the facts of the BMJ piece. Feel free to read into DeAngelis' call whatever you want. My own view is that she was likely angry and was calling Leo to intimidate him. She didn't call Lacasse. DeAngelis didn't return a request for comment. A spokesman for JAMA told me in an email that "It is unlikely that she will respond as she would consider her conversation with Jonathan Leo confidential information." He didn't answer my further question of how regularly DeAngelis picks up the phone to express her upset to researchers. JAMA also didn't answer questions about whether Forest purchased article reprints of the May 2008 study from JAMA. That's an important point because when a pharma company has its product appear favorably in a medical journal, they invariably purchase glossy reprints from the publishing journal in order to distribute them to doctors. And what pharma company wouldn't want to waive a positive study of its soon-to-be-off-patent drug in the face of every cardiologist and internist in the country? It's well-known that Forest is a very aggressive company when it comes to marketing as established by last month's revelation that the feds had filed a complaint against Forest for allegedly illegally marketing Lexapro and Celexa (which it also makes) for use in children even though the drugs are not approved for use in children. Making matters more interesting is that yesterday, JAMA published a letter (pdf) from Robinson and one of his study colleagues, fessing up to Robinson getting money from Forest Labs in the past and to Stephan Arndt, a co-author, failing to disclose that he had owned Pfizer stock in 2005 and 2006. It reads, in part: "We would like to apologize to the editors and readers of JAMA for our failure to report these financial disclosures in our article. Although Forest Laboratories provided honoraria and expenses through their speakers’ bureau for Dr 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. We sincerely regret this lack of transparency in our initial disclosures that resulted from these errors of memory." (Emphasis mine.) Errors of memory is an interesting explanation. JAMA didn't respond to my question as to whether Robinson and Arndt contacted the journal recently after they remembered their incomplete disclosures or if JAMA contacted them after Leo and Lacasse brought Robinson's conflict to JAMA's attention. I find it difficult to understand why DeAngelis would be upset with Leo since he had aided the journal is setting the record straight on whatever conflicts the Lexapro study authors had and on establishing that the authors found psychotherapy as effective as Lexapro. I find it tough to fathom in light of various hosannas that are regularly sung to DeAngelis, such as this one last year from the American Academy of Child and Adolescent Psychiatry: "Catherine D. DeAngelis, M.D., M.P.H, is the recipient of the American Academy of Child and Adolescent Psychiatry (AACAP) Catcher in the Rye Humanitarian of the Year Award. Dr. DeAngelis is Editor of the Journal of the American Medical Association (JAMA) and is credited with enforcing one of the most rigorous disclosure policies of any academic publication. That's quite some leadership she's showing, but when the judges are the AACAP, which represents a branch of psychiatry so riven by conflicts of interest (Harvard's Joseph Biederman anyone?) that it's hard to sort out where the science begins and the pharmaceutical propagandizing stops, then that's saying something. It's of course ironic that DeAngelis would get the Catcher in the Rye award. Holden Caulfield, the book's hero, often refers sarcastically to people he doesn't care for as being a "prince." Which I suppose makes DeAngelis a princess, at least in Holden's eyes. Posted by Philip Dawdy at March 12, 2009 12:03 AM
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.."where the science begins and the pharmaceutical propagandizing stops..." Great, great article. She's probably not disclosing something of her own, she's got a lot to lose if she's making personal phone calls and the conversation leaves a person quaking in their boots. Maybe they've both been threatened by pharma-goons for speaking out. I wouldn't be surprised if it was a death threat. Posted by: Stephany at March 12, 2009 03:26 AMRecord the conversations people! I have heard of other stories of people getting upset at real facts, real science being disclosed, but it is always second hand. Wow - a premier case to dig into. This study has even more funny stuff going on. One: Thus, it is totally plausible that the study was changed to a patentable medication. Why? By getting Robinson to switch the medication o nhis grant, the pharmaceutical company would be able to submit for a new FDA indication: escitalopram for prevention of post-stroke depression. Thus, any prescriptions to stroke patients would yield the bounty of a patented med. Translation from clinical evidence to practice could be handled by 1. heavy marketing and 2. influence upon post-stroke care guidelines. In contrast, what would benefit humanity more would be to test a med that is no longer under patent - cost savings would translate to greater uptake by the post-stroke patients, leading to greater rates of prevention of depression for post-stroke patients. As we all can guess, stroke patients are generally older, thus strongly affected by health insurance access and cost problems. That is my tip for ya. I am too busy to go ask Robinson why he changed med from citalopram to escitalopram. I myself am cynical, and believe it is very likely that it was for the financial benefit - the under-patent issue - I just mentioned. TWO: Who were the "counselors," or "therapists," or "mental health professionals," who delivered the PST? Doesn't it seem utterly intuitive, obvious, common-sense, etc.? that you would have, in a NIH-funded study comparing a psychotherapy intervention to a pharmacological intervention, that you would actually used a licensed mental health professional? Otherwise, how could you declare that the medications, fair-and-square, were equal to, or were superior to, talk-therapy? Ok. Now look at the small print FOLLOWING, not IN, the article. Two people receive "thanks" for conducting the PST. The credentials of one person indicate a bachelor's degree. No offense to anyone, but there is no state where a person with just a bachelor's degree alone is sufficient to qualitfy for a mental health professional license. In short, this person is clearly not a licensed MH professional. The other person's credentials indicate: master's degree. In what? In counseling? In psychology? Is this person licensed in any sort of mental health capacity? We readers of JAMA have absolutely NO indication of the answer in the text proper, or in the acknowledgements at the end of the article. Thus, based o nthis peer-reviewed, DeAngelis-approved article, we know the medication arm, but we have no idea regarding the quality and credentials of the two people delivering the psychotherapy arm. If you look OUTSIDE the study, you can discover that Iowa, where this study took place, provides a website with ALL licensed professionals - barbers, exterminators, etc. This site includes the various categories of licensed mental health professionals. "Iowa bureau of professional licensure." https://eservices.iowa.gov/ibpl/index.php?pgname=pub_verify The person who is recognized as performing the PST who has the master's level credential is listed nowhere. However, a medline or google search will show that this person has collaborated with Robinson and U of Iowa psychiatry on numerous studies. Is it possible that this person might have bias toward Robinson's preferred intervention arm? And thus bias might spill over into the integrity of the PST intervention? From this modest bit of inquiry, it looks like neither of the people who delivered the PST psychotherapy were actual bona fide mental health professionals. But both do have the issue of bias, since Robinson and U Iowa psychiatry provide their jobs. In other words, Robinson and colleagues tested an antidepressant pill versus an antidepressant psychotherapy, but had laypersons carry out the psychotherapy arm. Laypersons with a vested interest: continued employment with U Iowa psychiatry. Would a surgery study use general practitioners to perform an established surgery arm of a study, but use surgeons for the new-technique arm of a study when attempting to evaluate the potential superiority of a new surgery technique? How well might have PST performed if it actually was performed by therapists? It is totally plausible that the results may have ended up being at least equal, but perhaps show superiority, for PST. Now: compare side effects of PST with side effects of escitalopram. Consider: both have similar efficacy for preventing stroke. I myself would pick the talk therapy. Robinson is free to pick the pill, as he has apparently declared. Those are the two plot twists I have to add to this sordid story. FS has risen to such a level of notoriety that I have a feeling that JAMA and maybe U Iowa Psychiatry will read this blog. If so: JAMA / DeAngelis: maybe if you contact Dawdy, he can facilitate communication in case you want to peer-review your psych studies. But keep in mind that your advertisers will not be happy with me. Posted by: MedsVsTherapy at March 12, 2009 06:57 AMRegarding the revealed conflict of interest issue: Currently, there are various norms regarding COI disclosure. One common norm is certainly to report whether you have received funding for a specific study, i.e., who the study sponsors are. This is one way to side-step the issue. Big Pharma could fund you in any one of many ways, but NEVER fund you to test escitalopram for prevention of post-stroke depression. Thus, you can declare that yuor study is free and clear of any tqaint from COI. By the strict definition, i.e., who sponsored this specific study, you are being "honest." How do you otherwise discover COI? You look at whatever study, and figure out what med is under patent. You figure out what company makes it. You google the authors' names, and google that company name. Works very well. Posted by: MedsVsTherapy at March 12, 2009 07:07 AMWow. Good piece, Philip. Very well done. Thanks. Posted by: Sherry at March 12, 2009 07:39 AMGood job on this story. DeAngelis needs to get her tiara polished because it's looking a tad dirty. Posted by: Amy Philo at March 12, 2009 08:07 AMBut... but... "antidepressant use tied to cardiac death in women..." This link is just for you, Philip. - tig Posted by: unowho at March 12, 2009 09:24 AM"We find most people would rather just take a pill." Yeah, until a year later when they try to stop taking the pill and have crazy zaps in their head that feel like someone's dragging a staticy blanket over their brain. Posted by: David at March 12, 2009 10:12 AM"Robinson told the paper, "I think every stroke patient who can tolerate an antidepressant should be given one to prevent depression." Tom Insel, NIMH director, pretty much pooh-poohed the psychotherapy results, telling the paper, "We find most people would rather just take a pill." Robinson told the AP this: "I hope I don't have a stroke, but if I do, I would certainly want to be placed on an antidepressant."
What you need is time to heal not neurotransmitter scrambling drugs which give brain zaps. If I have a stroke and I hope I don't but if I did and they tried to coerce me to take an antidepressant I would tell them to go F themselves and rely on meditation to get my brain back to functioning and tai chi to get my body back. According to National Stroke Association stroke recovery entails # A rehabilitation unit in the hospital Screw that. Just get me out of the hospital as soon as possible and I'll teach myself how to walk and talk again on my own. Of course that's just theorycrafting on my part but still, I hate hospitals and the medical environment and the things they want to do you. The only reason I would ever want hospital care or 'allopathic' medicine is if I got shot or run over by a semi. Tai chi can't get rid of bullets and their holes or partial amputation. Western medicine is quite advanced there. But while I am recovering, give me the morphine and don't waste my time using the most recently patented SSRI meds. I'll take my chances with opiate dependency versus having to taper down from the latest not so great meds. You don't speak for me or my medical related interests Robinson so keep your recommendations to yourself. The last thing I want to do while recovering from a stroke is battle wills with a nurse trying to do her job giving me preventative antidepressants. I'll suffer the depression Doc, thanks but no thanks. Posted by: Jane A at March 12, 2009 12:30 PMRegarding Lexapro: This man in his 20's with no previous criminal record received the death penalty and his crime was partially or probably caused/exacerbated by his use of Lexapro. He was arrested the same night and had this to say about Lexapro in his videotaped interview. The case is so horrific that I have only copied and pasted a small portion of it. http://www.ssristories.com/show.php?item=166 Paragraph 15 reads: "In the videotaped interview, Underwood said his fantasies involving cannibalism began about the time he started taking the antidepressant Lexapro. Defense attorneys plan to call witnesses during the penalty phase of the trial who will testify that Underwood often appeared detached from reality and was using the drug." http://ap.google.com/article/ALeqM5hbE0lrv6z4DxqYAQ-AdGOoj2ceMAD8V3LVQ00 No Defense Case in Grisly Okla. Slaying NORMAN, Okla. (AP) Jurors on Thursday heard a soft-spoken man describe in a videotaped interview how he lured a 10-year-old-girl into his apartment, killed her --------------------- Posted by: Rosie at March 12, 2009 01:37 PMIt seems pretty clearly riddled with bias when they have a press release about the drug and omit mention of the psychotherapy results. Not a very brilliant comment about how most people just want to take a pill. Posted by: Doug Bremner at March 12, 2009 02:07 PM>Tom Insel, NIMH director, pretty much pooh-poohed the psychotherapy results, telling the paper, "We find most people would rather just take a pill." I wonder how many people "would rather just take a pill" if they were given FULL INFORMATION to form informed consent. I bet that total guesstimate changes a bit, don't you? Posted by: InTheWild at March 12, 2009 02:27 PMAtypical antipsychotics are associated with an increase in the risk of stroke particularly in the elderly; antidepressants are associated with an increase in bleeding and possibly with a decrease in healing after a stroke. Why in heavens' name would anyone want to take one of these drugs that cross the blood brain barrier after a stroke and open the door to all sorts of brain abnormalities and bizarre events? As if one wouldn't have enough to deal with after a stroke. These recommendations for everyone to pop a little Prozac after a stroke are based on outrageous science first and then biased promotion second. And it's darn insidious to have Catherine DeAngelis put on a public face of being a whistleblower about conflicts of interest and then get in her bully pulpit of power behind the scenes and blast anyone else who tries to do the same. Posted by: Sara at March 12, 2009 02:34 PMThank you for this Philip. Posted by: Ana at March 12, 2009 03:26 PMGreat job Philip. The layers of irony just keep piling up. This piece really makes obvious the blatant suppression (or is it really just the absolute blind dismissal?) of psychotherapy as useful therapy. What is hard is to choose which aspect of this tangled mess makes the best hook for raising public awareness. Keep up the good work. I'm so glad you are reporting this stuff. Posted by: Gene Combs at March 12, 2009 08:46 PMPost a comment
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