^{Professor Nemeroff’s sole publication of original data in this area appeared in 2003. It was a secondary analysis of a large clinical trial, first reported in 2000, that originally did not consider child abuse as a moderating variable in the response of chronically depressed patients to an antidepressant [nefazodone] or to cognitive behavior therapy [CBASP]. The 2003 report claimed that, in patients with a history of childhood trauma, response to CBASP was superior to response to nefazodone. At the same time there was no significant difference in response rates to drug or to CBASP between patients with or without childhood trauma histories. A portion of this report was later retracted because the data concerning reduction of Hamilton depression scores had been misrepresented.}

Differential responses to psychotherapy versus pharmacotherapy in patients with chronic forms of major depression and childhood trauma.
^{by Nemeroff CB, Heim CM, Thase ME, Klein DN, Rush AJ, Schatzberg AF, Ninan PT, McCullough JP Jr, Weiss PM, Dunner DL, Rothbaum BO, Kornstein S, Keitner G, Keller MB.}
Proceedings of the National Academy of Science. 2003 100[24]:14293-14296.
^{[full text on-line]
Erratum [see below]}

^{Major depressive disorder is associated with considerable morbidity, disability, and risk for suicide. Treatments for depression most commonly include antidepressants, psychotherapy, or the combination. Little is known about predictors of treatment response for depression. In this study, 681 patients with chronic forms of major depression were treated with an antidepressant [nefazodone], Cognitive Behavioral Analysis System of Psychotherapy [CBASP], or the combination. Overall, the effects of the antidepressant alone and psychotherapy alone were equal and significantly less effective than combination treatment. Among those with a history of early childhood trauma (loss of parents at an early age, physical or sexual abuse, or neglect), psychotherapy alone was superior to antidepressant monotherapy. Moreover, the combination of psychotherapy and pharmacotherapy was only marginally superior to psychotherapy alone among the childhood abuse cohort. Our results suggest that psychotherapy may be an essential element in the treatment of patients with chronic forms of major depression and a history of childhood trauma.}

Erratum in Proceedings of the National Academy of Science. 2005 102[45):16530.
^{[full text on-line]}

^{MEDICAL SCIENCES. For the article "Differential responses to psychotherapy versus pharmacotherapy in patients with chronic forms of major depression and childhood trauma," which appeared in the Proc. Natl. Acad. Sci. in November 13, 2003, the authors note the following. "Results of the analyses of variance comparing change in Hamilton Rating Scale for Depression scores as a function of treatment type and early life trauma histories as well as Fig. 1A reflect change relative to the first week of treatment instead of baseline. When change scores relative to baseline are used, the interaction effects between treatment type and childhood trauma histories are not statistically significant. This discrepancy is due to marked changes in depression scores during the first week of treatment. Note that all analyses comparing the more conservative outcome measure of remission as a function of treatment type and childhood trauma as well as Fig. 1B are correct. Thus, consideration of treatment response relative to baseline does not detect the effect of childhood trauma on final remission, whereas consideration of final response relative to first response does detect the effect."}

This is reported as if it’s simply an error, but to my reading, it’s a fatal error. The whole point of the article is that in this depressed cohort, those with child abuse histories responded to Cognitive Psychotherapy but not to Antidepressants. That’s the title of the article! And it wasn’t significant after all! They had done their statistics using the week 1 data rather than the baseline! This error invalidates the whole study. I can find no evidence that the now invalidated article was retracted, just that the error was reported. Last week [character is pervasive…], I had said, "…having heard and read Dr. Nemeroff’s body of work for over twenty years, it has always felt like teflon science." This is the kind of thing I was talking about – slippery, always slippery. So I thought I’d follow the thread of this article backwards to its source. And that’s when I fell into the deepest of holes, and down I tumbled. I’ll spare you all the sites I saw along the way, and get straight to what was at the bottom of the hole – this article in the New England Journal of Medicine:

A Comparison of Nefazodone, the Cognitive Behavioral-Analysis System of Psychotherapy, and Their Combination for the Treatment of Chronic Depression
^{by Martin B. Keller, M.D., James P. McCullough, Ph.D., Daniel N. Klein, Ph.D., Bruce Arnow, Ph.D., David L. Dunner, M.D., Alan J. Gelenberg, M.D., John C. Markowitz, M.D., Charles B. Nemeroff, M.D., Ph.D., James M. Russell, M.D., Michael E. Thase, M.D., Madhukar H. Trivedi, M.D., Janice A. Blalock, Ph.D., Frances E. Borian, R.N., Darlene N. Jody, M.D., Charles DeBattista, D.M.H., M.D., Lorrin M. Koran, M.D., Alan F. Schatzberg, M.D., Jan Fawcett, M.D., Robert M.A. Hirschfeld, M.D., Gabor Keitner, M.D., Ivan Miller, Ph.D., James H. Kocsis, M.D., Susan G. Kornstein, M.D., Rachel Manber, Ph.D., Philip T. Ninan, M.D., Barbara Rothbaum, Ph.D., A. John Rush, M.D., Dina Vivian, Ph.D., and John Zajecka, M.D.}
New England Journal of Medicine. 2000 342[20]:1462-1470.
^{[full text on-line]}

Methods: We randomly assigned 681 adults with a chronic nonpsychotic major depressive disorder to 12 weeks of outpatient treatment with nefazodone [maximal dose, 600 mg per day], the cognitive behavioral-analysis system of psychotherapy [16 to 20 sessions], or both. At base line, all patients had scores of at least 20 on the 24-item Hamilton Rating Scale for Depression [indicating clinically significant depression]. Remission was defined as a score of 8 or less at weeks 10 and 12. For patients who did not have remission, a satisfactory response was defined as a reduction in the score by at least 50 percent from base line and a score of 15 or less. Raters were unaware of the patients’ treatment assignments.

Results: Of the 681 patients, 662 attended at least one treatment session and were included in the analysis of response. The overall rate of response [both remission and satisfactory response] was 48 percent in both the nefazodone group and the psychotherapy group, as compared with 73 percent in the combined-treatment group [P<0.001 for both comparisons]. Among the 519 subjects who completed the study, the rates of response were 55 percent in the nefazodone group and 52 percent in the psychotherapy group, as compared with 85 percent in the combined-treatment group [P<0.001 for both comparisons]. The rates of withdrawal were similar in the three groups. Adverse events in the nefazodone group were consistent with the known side effects of the drug [e.g., headache, somnolence, dry mouth, nausea, and dizziness].

Conclusions: Although about half of patients with chronic forms of major depression have a response to short-term treatment with either nefazodone or a cognitive behavioral-analysis system of psychotherapy, the combination of the two is significantly more efficacious than either treatment alone.

^{[reformatted for clarity]}

Is Academic Medicine for Sale?
^{by MARCIA ANGELL, MD}
New England Journal of Medicine. 342[20]:1516-1518.
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In 1984 the Journal became the first of the major medical journals to require authors of original research articles to disclose any financial ties with companies that make products discussed in papers submitted to us. We were aware that such ties were becoming fairly common, and we thought it reasonable to disclose them to readers. Although we came to this issue early, no one could have foreseen at the time just how ubiquitous and manifold such financial associations would become. The article by Keller et al. in this issue of the Journal provides a striking example. The authors’ ties with companies that make antidepressant drugs were so extensive that it would have used too much space to disclose them fully in the Journal. We decided merely to summarize them and to provide the details on our Web site.

Finding an editorialist to write about the article presented another problem. Our conflict-of-interest policy for editorialists, established in 1990, is stricter than that for authors of original research papers. Since editorialists do not provide data, but instead selectively review the literature and offer their judgments, we require that they have no important financial ties to companies that make products related to the issues they discuss. We do not believe disclosure is enough to deal with the problem of possible bias. This policy is analogous to the requirement that judges recuse themselves from hearing cases if they have financial ties to a litigant. Just as a judge’s disclosure would not be sufficiently reassuring to the other side in a court case, so we believe that a policy of caveat emptor is not enough for readers who depend on the opinion of editorialists……

• Industry Funded Clinical Trial: The study in question was an industry funded clinical trial of Nefazodone against Cognitive Behavior Therapy or both. Since there’s no Placebo Group, the only conclusion is that the combination was better than either treatment but we can conclude nothing about the effect size.
• Multiple Authors, Multiple Publications: It’s inconceivable that it took 29 authors to do this study. The author list looks like a KOL convention with many familiar mega-résumé names [and four authors who would end up on Senator Grassley's COI investigation list 8 years later]. When I referred to the sites I saw along the way, I was talking about the number of articles published using this same data and some combination of these multiple authors. It was reminescent of John Rush’s STAR*D study where the same thing occurred – endless papers with multiple authors looking at different aspects of the data after the fact. I call it résumé-churning. It took me a while to work my way back to even find the original NEJM article in 2000.
• Conflict of Interest: The Conflict of Interest list on the original article was so long that the NEJM didn’t even include it in the printed journal but posted it on their web site. It obviously caught the editor’s attention and she penned a damning editorial that later became a cause célèbre for her. Is Academic Medicine for Sale? is an eloquent early indictment of the pharmaceutical-academic alliance that we came to know all too well.
• Nemeroff’s paper – the Erratum: In Nemeroff et al in 2003, much was made of a difference in response between the antidepressant and CBT only in patients with a childhood abuse history. This was hardly raised as an issue at the time of the study – an undeclared parameter. So this is what’s called HARK – hypothesis after the results are known. It’s ihe kind of thing you find if you run statistics on everything imaginable after the fact until you hit on something. So they reported his findings. Two years later, they published an Erratum that says the central thesis of the article wasn’t significant after all [with what I would call a very suspicious error]. Even though the error invalidated the results, the paper was not officially retracted.
• Back where we started: So finally back to Dr. Carroll’s point. In spite of the fact that the 2003 Nemeroff et al study was invalidated in 2005, it’s still being presented as a positive study. In fact, it’s on the front burner of the Treatment Implications section of Dr. Nemeroff’s presentation. In his Grand Rounds presentation at NYU in 2012, there it is [@41:10]. The graph from the original 2003 paper is on the left and the one from 2012 is on the right,
   
  unchanged even though the reported error invalidates this specific slide:
  ^{Results of the analyses of variance comparing change in Hamilton Rating Scale for Depression scores as a function of treatment type and early life trauma histories as well as Fig. 1A reflect change relative to the first week of treatment instead of baseline. When change scores relative to baseline are used, the interaction effects between treatment type and childhood trauma histories are not statistically significant.}

To be honest, I can’t figure out how this study fits into his lecture about The Neurobiology of Child Abuse when everything that comes before is about genetic predisposition and neurogenesis changing the brain. I guess he needed something to say about Treatment Implications at the end. But using data that he knew was in error is inexcusable. It took the trained eagle eyes of Dr. Carroll to see it, and I expect that most of this kind of subtle sleight of hand goes right over most readers. But once it’s pointed out, it’s pretty appalling.

From my perspective, the DSM-IV did the best it could do with the whole issue of the Bipolar Child craziness. I lay the responsibility for that one not on the DSM-IV but on Drs. Biederman and Wozniak at Harvard, the pharmaceutical sponsors, but mostly on the the community of child psychiatrists who accepted and promulgated the idea with no solid evidence base. Like "Treatment Resistant Depression," the "Bipolar Child" was a creation of the psychopharmacology era itself – a rationalization for the inappropriate use of powerful and dangerous medication for behavior control.

^{Psychiatric labels, be it "ADHD" "bipolar disorder" or "autism," are artificial constructs that provide a false sense of simplicity. When I see a child and family in consultation, the aim of the work is to take the time to listen to the story and understand where, and it may be in several places, the "problem" actually lies. In order to help these children and families in a meaningful way, we need to be able to, in the words of one of my mentors Ed Tronick, "embrace complexity."}

^{hat tip to Jamzo…}

1. a movement…
2. to make distortion possible…
3. the lesson of Study 329: the basics…
4. the lesson of Study 329: efficacy drift to trends and 2°s…
5. the lesson of Study 329: conventions and protocols…
6. the lesson of Study 329: clues and adversities…
7. the lesson of Study 329: uh-oh!…
8. the lesson of Study 329: data transparency…
9. the lesson of Study 329: the authors…
10. the lesson of Study 329: the hurdles…
11. the lesson of Study 329: naked Emperors, fractious Queens…
12. the lesson of Study 329: “we’re only as sick as our secrets”…
13. the final lesson of Study 329: epilogue…
14. the lesson of Study 329: an unfinished symphony…

^{I was watching a youtube video of a BBC Panorama program about Paxil Study 329. They interviewed Dr. Mina Dulcan, the editor of the Journal of the American Academy of Child and Adolescent Psychiatry who had accepted the study over the objections of the peer reviewers. She first talked about the Journal’s classy ranking [@13:57]. Then, when asked if she had any regrets about publishing it [@14:58], she said, "Oh I don’t have any regrets about publishing at all. It generated all sorts of useful discussion, which is the purpose of a scholarly journal."}

^{"We rank – and this is a world-wide ranking – we rank number one in child mental health and number two in pediatrics."}

No journal editor or sponsoring organization, no matter how prestigious, should have the power to decide to leave something like this article reporting Paxil Study 329 that has been so thoroughly discredited in the scientific literature unchallenged, in perpetuity. No academic scholars who understood the responsibility of their respected positions would. But that’s exactly what has happened. So unless someone in the American Academy of Child and Adolescent Psychiatry comes to their senses and finally retracts the 2001 article [Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial], I would predict that Paxil Study 329 will be the very first candidate for the proposed "restorative publication."

I was writing a comment on the Doshi et al article about RIAT, and one of those word things happened for the first time in a long time. It was with the word academic. What I was trying to talk about was our academic journals and why publishing clinical trial reports without access to the full raw data shouldn’t fly. I had said that the thing that made a journal academic was that the articles were peer reviewed both before being published, and afterwards. I was claiming that without the raw data, there could never be genuine peer review, so such studies shouldn’t really have been published in academic journals in the first place. It was an AllTrials kind of argument [an argument I'd already made awkwardly in “a bold remedy”…].

I’d never really thought about the word academic before, but all of a sudden, the literal meaning occurred to me. If you look into some set of facts and conclude that you’ve figured out something about them, it’s just an opinion. But if you lay out your opinion in an article that you present to the whole academy for scrutiny and debate, it becomes academic. But that’s only true if the members of the academy can see all of the same facts that you saw. What we are calling data transparency is an integral part of the definition of the word. Academic means expanding [and exposing] the vision of individual scholars to that of the academy of scholars as a whole. So a journal with embargoed primary data is not an academic journal. It’s something else – something that doesn’t belong in the library at the academy.

Is this semantics? just some other piece of common knowledge that I’m catching onto as a late bloomer? After all, scientific papers have always been published without the stacks of data notebooks [and later computer print outs] that sit behind most scholarly articles. But it really was different in the past. If you wanted to see somebody’s primary data, you could. I did that  in the late 1960s in another incarnation, traveling to a distant lab to look at their data and taking my notebooks for review. I was a lowly fellow and they were the established scholars, but they treated me like a peer, seemed glad to see me, and together we figured out why we got different results. I can’t imagine this business of data-as-private-property in those days. It seems a recent creation of this industry-funded-industry-executed clinical trial era.

I recalled another one of those word things from the past. I was watching a youtube video of a BBC Panorama program about Paxil Study 329. They interviewed Dr. Mina Dulcan, the editor of the Journal of the American Academy of Child and Adolescent Psychiatry who had accepted the study over the objections of the peer reviewers. She first talked about the Journal’s classy ranking [@13:57]. Then, when asked if she had any regrets about publishing it [@14:58], she said, "Oh I don’t have any regrets about publishing at all. It generated all sorts of useful discussion, which is the purpose of a scholarly journal." I really balked at the word "scholarly." I didn’t linger then, but it sounded effete at the time. It felt embarrassing. Thinking about it now, the discussion it generated wasn’t "scholarly" at all – as in a debate among scholars. It was more like IRS Auditors discussing how to sleuth out hidden off-shore accounts. A scholarly discussion is about interpretation and meaning, not about access to the basic observations.

Having lived among a lot of academic scholars in my life [the kind that wear multicolored robes at graduation], I think I’ve always glazed over when the talk turns to lofty academic matters like tenure, authorship, plagiarism, academic rank, promotion, scholarship, etc. – those things that preoccupy the inhabitants of ivory towers. I recant! Having witnessed the corruption and deterioration in academic psychiatry in the last quarter century, I take it all back. I now see that the cumbersome ways of academia proper are there for a solid reason. This would never have happened in a department of philosophy or of comparative literature where the traditions and rules of the academy are debated at almost every faculty meeting. Free access to information is a sacrosanct element of academic freedom and scholarship. Mea Culpa!

Drug companies have a year to publish their data, or we’ll do it for them
THE CONVERSATION
by Tom Jefferson
June 14, 2013

As a doctor it’s my job to prescribe lotions and potions. To do so, I read information about drug trials in books and medical journals to keep me up to speed on the latest drugs, dangers and side effects. But what if what I read is part of an elaborate marketing strategy by a drug company to use me to get to you?

This happens all the time. So much so that the saturation of scientific literature with commercial messages has come to the point where some of those of us who work full time in this area don’t trust the literature anymore. I can read something about a drug and find that the majority of the data about it – for example as I argued in a recent article on Tamiflu – is missing. This is not because the work hasn’t been done, but because it has been deliberately hidden. What has been published might have important discrepancies with what probably really happened during a clinical trial into the drug. We just don’t know.

It’s a story that involves everyone: scientists, pharmaceutical sponsors, editors of biomedical journals and the media. Ultimately it is you who suffers. At school, if you made a mistake the teacher would ask you to explain it and get you to correct it in your exercise book. The same should go for unpublished and misreported trials. They should be published and formally corrected to ensure doctors and patients can rely on complete and accurate information about the treatments we use.

In the public domain we have hundreds of highly detailed regulatory reports of trials which were never published [invisible] or distorted in the way the results were presented. Some were even ghost written and we also know by whom and for how much money.

A year to publish and correct

There is now a proposal, backed by the British Medical Journal [BMJ] and PLOS Medicine, to ask drug companies to publish and correct all data – including on medicines already in circulation – within the next year. Otherwise independent scientists will begin doing it themselves. Volunteer researchers – currently being signed up – will be able to pick an invisible or distorted trial, write to the drug’s sponsor and ask them to make it visible or correct the record – and drug companies will be given a year to do it.

If the company doesn’t respond within 30 days or turns the offer down, friendly journals will publish the paper and a longer one for the regulators. This way we can have several published versions of the same trial, with different interpretations and different data sets. There will be more free debate based on the data and no-one will have a monopoly control. Everything will be out in the open and will potentially be good for your health.

You may think that multiple versions of the same trial or many public letters and correspondence may cause confusion. But this controlled release of information is precisely what has brought us to this situation. In the Middle Ages scientists were kept under control by physical threats, today control is exerted on what information we’re able to see. An open society needs an open debate – with all the data available.

RIAT and AllTrials are part of the same initiative and are being proposed by many of the same people with the BMJ, PLoS Madicine, and the Cochrane Collaboration as the driving organizations. There are other threads to this story: the EMA data dump, the TEST Act, the results reporting on clinicaltrials.gov, just to mention a few. What I personally like about RIAT is that it’s not a rush to action, an attempt to cure the disease that clinical trials have introduced into medicine. It’s aim is to put the problem squarely into the public and academic domains – the light of day. And it almost by definition brings the medical journals and their peer review policies into the heart of the dialog. The problem is bigger than just the pharmaceutical/academic alliance, or the problems of ghost-writing and deceitful science, or the problems introduced by the pressures of the third party carriers. The whole question of the place of academic medicine in the world of academia is an intimate part of the story.

In the story of every tension, there’s a time for reflection and understanding, and then there’s a time for action. But what action? The strange professor in my World Religion I Course had a lecture he’d given countless times, always with the same passion as the first day he wrote it. "Primitive man," he said, "had only two paths to follow in the face of an inhospitable nature." After a long pause, he continued, "Pious Petition – praying to the universe for mercy, And…" After another pause, he adopted an impish grin, "Magic! – trying to force the universe into compliance." He went on to talk about how the former became religion and the latter was the precursor to science [the pity was, that first lecture kept us from dropping the course, but the following months could only be called soporific].

The time for just decrying the shameful abuse of clinical trials in psychiatry and the rest of medicine has passed. The books and blogs are joined in a monotonous lamentation of the way clinical trials have been conducted. Prophetically, the first major action with traction was a petition – AllTrials – not totally pious, but a request nonetheless. In the background, the magicians have been stirring. The Cochrane Collaboration, Peter Doshi, and Tom Jefferson have been playing hard chess with Roche around the billion dollar efficacy questions with Tamiflu. Healthy Skepticism and others have dogged the JAACAP over Paxil Study 329 for a decade. Dr. David Healy’s Pharmageddon and Rxisk database have taken on trials as well as adverse effects in general. Comes now RIAT [Restoring Invisible and Abandoned Trials] backed by a broad collaboration proposing a plan to add some teeth to the demands for clinical trial reform, focusing on missing and jury-rigged studies. The plan was announced today by the British Medical Journal and PLoS Medicine:

Restoring invisible and abandoned trials: a call for people to publish the findings
Analysis
British Medical Journal
^{by Peter Doshi, Kay Dickersin, David Healy, S Swaroop Vedula, and Tom Jefferson}
June 13, 2013
^{[full text on-line]}

Restoring the integrity of the clinical trial evidence base
Editorial
British Medical Journal
^{by Elizabeth Loder and Fiona Godlee [BMJ] and Virginia Barbour and Margaret Winker [PLoS Medicine]}
June 13, 2013
^{[full text on-line]}

Restoring Invisible and Abandoned Trials: A Creative Approach to a Public Good; Now a Creative Approach to Implementation is Needed
Blog
PLoS Medicine
^{By Margaret Winker and Virginia Barbour}
June 13, 2013
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^{Academic freedom is the belief that the freedom of inquiry by faculty members is essential to the mission of the academy as well as the principles of academia, and that scholars should have freedom to teach or communicate ideas or facts [including those that are inconvenient to external political groups or to authorities] without being targeted for repression, job loss, or imprisonment… Academic tenure protects academic freedom by ensuring that teachers can be fired only for causes such as gross professional incompetence or behavior that evokes condemnation from the academic community itself.}

The pharmaceutical clinical trials have been accepted into our scientific literature based on the assumption that the academic authors know the rules and are accurately representing the data. But there is widespread evidence that this is an erroneous assumption. Many of the academic authors are compromised by conflicts of interest [or are not even the actual authors]. The traditional counterpose is peer review, but this has been blocked by a firewall with the claim that the raw data is private property.

There are only two solutions to this problem. The first is to deny access to the academic literature to any study withholding public access to the raw data itself. That is the approach taken by the AllTrials petition – an eminently sensible solution. But it doesn’t address the volumes of studies already published, and their authors and sponsors aren’t being forthcoming. I guess they’re claiming the rights of a former loophole.

^{The lecture is on ‘The Neurobiology of Childhood Abuse: Treatment Implications’ and is a purely academic event, advertised to local academics and mental health professionals, and not open to the public. Professor Nemeroff has been invited due to his world – leading expertise in this research field, specifically in the neuroscience underpinning the relationship between experiences of early abuse and the subsequent development of affective disorders. This is an area where his academic impact, in terms of publications in prestigious journals, invited lectures at conferences and academic events worldwide, and recognition by professional societies, is irrefutable .}

Nemeroff has been impeached by his peers. That is the reason for the protests: He brought dishonor on our field, and heavy sanctions were applied, to a degree that is almost unprecedented – banned from involvement in NIH grants for 2 years; eased out of a prestigious journal editorship [Neuropsychopharmacology]; dismissed from his departmental chairmanship at Emory University. It says a lot about the ethical sensibility and moral compass at Institute of Psychiatry, King’s College, London that they persist in their invitation of Nemeroff.

Who cares about his perceived expertise? Is he an ethical role model for peers and trainees? What were they thinking? Were they thinking? The IoP will be tainted by this episode for years to come, and the responsible administrators deserve all the frowns and brickbats that will come their way. Here is a general discussion of the need for academic institutions to show some spine in such matters.

I don’t agree with those things intuitively or clinically, but more importantly, having heard and read Dr. Nemeroff’s body of work for over twenty years, it has always felt like teflon science with the same opacity as his expense reports or excuses when he’s been busted for one thing or another. And it says something that few outside his own orbit ever bother to repeat his findings. In my mind, these are conclusion in search of supportive evidence without ever coming in for a three point landing. As I’ve mentioned before, you can preview a version of his IoP presentation here [sans "treatment implications"].

^{hat tip to Mick Bramham…}

^{"this is part of a long term campaign to promote ‘national depression centers’. This seems like step in grand plan of National Network of Depression Centers"}

^{…To achieve this, we must develop sustainable networks with “big-data” capacities. Networks that come and go with brief grant funding will not suffice. Early prototypes such as the National Network of Depression Centers have been started for depression, bipolar illness, and related conditions, but financial supports will be needed to fully develop their potential.}

 

But on the National Network of Depression Centers web site, we find this:

The National Network of Depression Centers is a non-profit consortium of twenty academic institutions all with varying implementations of a Depression Center with both Clinical and research arms. It looks to be modeled after the various Cancer Center networks:

^{Dr. John F. Greden is the Rachel Upjohn Professor of Psychiatry and Clinical Neurosciences in the Department of Psychiatry, Founder and Executive Director of the University of Michigan Depression Center, Founding Chair, National Network of Depression Centers [NNDC], and Research Professor in the Molecular and Behavioral Neuroscience Institute. He joined the faculty at the University of Michigan Medical School in 1974 and served as Chair of Michigan’s Department of Psychiatry from 1985 to 2007 when he stepped down to focus on directing the Depression Center and developing the NNDC.}

Was there a conflict of interest on Dr. Greden’s part? Absolutely. Had he declared, "Dr. Greden is Executive Director of the National Network of Depression Centers and Executive Director of the University of Michigan Depression Center" for which we can only presume he is paid, one would’ve read that editorial in a very different light. Should the American Journal of Psychiatry have published an infomercial as an editorial? Absolutely not. And what about it being associated with an article about an NIMH Study penned by Dr. Trivedi? And what about the fact that Dr. Greden’s editorial is filled with Dr. Trivedi’s very familiar jargon about measurement-based care, sequencing, etc.? even though this paper didn’t support that sequencing algorithms are effective? and even though STAR*D is hardly a good example of measurement-based anything [see objectively… ]?

^{hat tip to Jamzo…}

A Soiled Phoenix Rises
Mad in America
by Philip Thomas, M.D.
May 30, 2013

^{It has been a good time to bury controversy. With all eyes on Washington and the fallout from the publication of DSM-5, over here in England the Institute of Psychiatry has been discretely sending out invitations to a lecture. This is not a public lecture; it is by invitation only. It is the Inaugural Lecture of a new Centre for Affective Disorders. What could possibly be controversial about that, you might well ask? It is perfectly normal for an august institution to invite an esteemed colleague to mark the launch of a new development by giving a guest lecture. This is slightly different. The lecture will be hosted by luminaries of the Institute of Psychiatry. Professor Carmine Pariante will chair the event; the guest speaker introduced by Professor Allan Young, and the vote of thanks proposed by Professor Sir Robin Murray. And who is this esteemed guest? None other than Professor Charles Nemeroff M.D., Ph.D.}

… There are two things you won’t find on Professor Nemeroff’s personal page on the University of Miami website. The first is details of his extensive business interests in the pharmaceutical industry. You have to scour the pages of Bloomberg Business Week to unearth this. Here you will find out that he has had consultancies with various industry leaders, including Forrest Laboratories, GlaxoSmithKlein, Janssen, Merck, Otsuka Pharmacia/Upjohn, Somerset Pharmaceuticals and Wyeth-Ayerst Laboratories. He has also served on the scientific advisory boards of most of these companies.

The second thing concerns conflicts of interest. In 2009, an investigation initiated by Iowa’s Republican Senator Charles Grassley found that when Nemeroff was Departmental Chair at Emory University, he failed to report in excess of $1 million income from GlaxoSmithKlein for giving over 250 talks to psychiatrists between 2000 – 2006. During this period he held a grant for $9 million from GSK for a trial of its drug, Paxil. In December 2009 he was dismissed from his post at Emory, and also banned by the National Institutes of Health from applying for research funding for two years. Shortly after this Nemeroff was appointed to his current post in the University of Miami, after Dr. Thomas Insel, the Director of the National Institute of Mental Health, reassured the University that Nemeroff would be eligible to apply for research funding once in post…

There is something of the night about Professor Nemeroff, and the darkness in his past can be grasped through reports some years ago of the part he played in the decision by the Centre for Addiction and Mental Health in Toronto to withdraw the offer of a Chair to Professor David Healy. Professor Nemeroff’s lecture at the Institute of Psychiatry goes under the title of “The Neurobiology of Child Abuse: Treatment Implications”. The question this raises is why is the Institute of Psychiatry so keen to ingratiate itself with this soiled Phoenix. The Director of the new Centre for Affective Disorders, and the person chairing the lecture is Professor Carmine Pariante. Professor Pariante worked at Emory in 2001, when Nemeroff was Departmental Chair. Is the Institute of Psychiatry courting Nemeroff for financial favors through his links with the pharmaceutical industry? Who knows? We do know, however, that as recently as March 2013 the Institute, in conjunction with the London School of Hygiene and Tropical Medicine, announced nine new scholarships in global mental health funded by Janssen to the tune of almost £300,000.

British psychiatry is in no sense perfect, but to be fair, the Royal College of Psychiatrists has worked hard to tighten up the egregious relationship between the profession and the industry… Yet on the surface it seems that one of our most esteemed institutions, a centre of academic excellence, is beyond the moral compass that guides the rest of the profession. In the interests of transparency we should be told why Professor Nemeroff has been invited to speak at the Institute of Psychiatry. Where has the funding for the new Centre for Affective Disorders come from? Is it linked to Nemeroff’s appearance and rehabilitation? We should be told.

Although the personal relationship between Dr. Nemeroff and Dr. Pariante and their shared interests might explain the invitation, it still doesn’t explain why wiser heads at the Institute of Psychiatry didn’t intervene at the suggestion. And Dr. Thomas’ questions at the end "…we should be told why Professor Nemeroff has been invited to speak at the Institute of Psychiatry. Where has the funding for the new Centre for Affective Disorders come from? Is it linked to Nemeroff’s appearance and rehabilitation?" remain unanswered.

Dr. Nemeroff was exposed for recommending treatments where he had a financial interest without disclosure in a review article in 2004. In 2006, he was again exposed when he published a ghost-written article reviewing a treatment that he and other authors had a financial interest in without disclosure in a journal that he, himself, edited. He was asked to step down as editor and censured by Emory University where he was Chairman. In 2008 after the US Senate investigated him for unreported pharmaceutical income, he was removed as Chairman at Emory. On the left above are the number of outside PHARMA consulting jobs he held per year and on the right the number of promotional talks he gave for GSK per month. Below, the journal articles he published per year…

There is no rational explanation why the Institute of Psychiatry at Kings College would select Dr. Charlie Nemeroff to give an annual lecture to inaugurate a new Affective Disorders Centre. His quirky research hinges around proving that childhood trauma reverse engineers the brain and predisposes to later depression – or that people are genetically loaded to be harmed by psychological trauma. He uses trendy terms like epigenetic or neurogenesis and all the latest technologies to come at these hypotheses from a variety of directions – always on the cutting edge, always seeing amazing breakthroughs just around the corner. Self reference punctuates every presentation [even his jokes are grandiose - as in his assertion that he's somehow connected to Jan Evangelista Purkinje, the famous Czech neurophysiologist, in a recent grand rounds @23:00]. He chases and then jumps in front of every fad that washes over the world of bio·psychiatry – a man for all seasons. But if he’s actually excelled at something, it’s making funny money for his corporate sponsors, his departments and universities, and for himself. So there’s simply no rational explanation why they would select Dr. Charlie Nemeroff to give an annual lecture to inaugurate their new Affective Disorders Centre – leaving us to ponder in disbelief that the Institute of Psychiatry at the prestigious Maudsley would voluntarily don the shroud that is Dr. Charlie Nemeroff?