WINDY CITY BLUES

<div class="MsoNormal">WINDY CITY BLUES<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">There is an academic ethics mess brewing in the windy city… at The University of Chicago. It involves a start-up Chicago corporation, a star statistician in the medical school, seed money in the form of NIH research grants, the American Psychiatric Association, and the chairman of the APA’s DSM-5 Task Force. It involves the appearance of self-interested bias in the DSM-5 process. It involves a recidivist pattern of failure to disclose material conflict of interest. And it involves academic journal editors (JAMA and JAMA Psychiatry) who did not do the right thing when the perps were outed.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">I broke the story <a href="http://hcrenewal.blogspot.com/2013/11/when-is-disclosure-not-disclosure.html">on this site</a> back in November, right after a <a href="http://archpsyc.jamanetwork.com/article.aspx?articleID=1780020">confession</a> appeared on-line in JAMA Psychiatry by the gang of five perps (Robert Gibbons, Ellen Frank, David Kupfer, Paul Pilkonis, and David Weiss) . Indeed, it was I who had alerted the journal. Others have since weighed in <a href="http://1boringoldman.com/index.php/2013/12/29/insider-trading/">here</a> and <a href="http://www.behaviorismandmentalhealth.com/2013/12/23/dsm-5-dimensional-diagnoses-more-conflicts-of-interest/">here</a> and <a href="http://www.psychologytoday.com/blog/saving-normal/201401/holding-psychiatry-much-higher-ethical-standard">here</a>, for instance. The definitive summary and Timeline were the work of Dr. John M. (Mickey) Nardo <a href="http://1boringoldman.com/index.php/2014/01/21/open-letter-to-the-apa/">here</a>. Of course, readers of JAMA Psychiatry would never know that the authors were outed. The editors (Howard Bauchner for JAMA and Joseph Coyle for JAMA Psychiatry) allowed the authors to make it seem like they were making a spontaneous admission of nondisclosure, and they acquiesced in the withholding of key information that I had given to the journal.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">It gets worse. We now know that the chair of the DSM-5 Task Force (Dr. David Kupfer) failed to disclose his financial conflict of interest on at least 4 occasions (#s 13, 15, 16, 19 in the Nardo <a href="http://1boringoldman.com/index.php/2014/01/21/open-letter-to-the-apa/">Timeline</a>). <i>On two of those occasions he was representing the DSM-5 team and the APA</i>! These lapses undermine his repeated assurances that COI issues were under control in DSM-5. If the chairman of the DSM-5 Task Force does not have his own act together concerning COI disclosures, then what are his assurances worth? Nevertheless, the APA released a <a href="http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&ved=0CDgQFjAC&url=http%3A%2F%2Fwww.psych.org%2FFile%2520Library%2FAdvocacy%2520and%2520Newsroom%2FLetter-to-Assembly-20140114.pdf&ei=8ZTaUoLaGfSrsQSJ14GgDQ&usg=AFQjCNE--psrRvauH2Ow3Xu9VKYfv9AItQ&sig2=WFYXTx1QYMMKjrS0DfMANQ&bvm=bv.59568121,d.cWc">statement</a> that tried to whitewash Dr. Kupfer’s nondisclosures. They need to recalibrate their ethical compass.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">The methods adopted in this affair are classic: Peddle unproven psychiatric screening scales backed up by black box statistics (a distressing specialty of Dr. Gibbons); publish a glowing report in JAMA Psychiatry, which you have infiltrated (Ellen Frank and Robert Gibbons are on the editorial board); get your corporate people inside the DSM-5 process (David Kupfer, Robert Gibbons, Paul Pilkonis); slant the DSM-5 process to endorse, however weakly, the kind of products you intend to market; start a corporation without telling anybody and establish a <u><a href="http://www.adaptivetestingtechnologies.com/">website </a></u> with advance marketing that touts your new academic publication in JAMA Psychiatry while <a href="http://www.adaptivetestingtechnologies.com/our-people.html">highlighting</a>Dr. Kupfer’s key role in DSM-5; loudly <a href="http://www.cmeinstitute.com/psychs-talk/#top">proclaim</a> (see page 4) the advent of population-wide screening but before doing any serious field trials or acknowledging that most positive screens will be false positives. This is the usual dodgy hand waving of wannabe entrepreneurs, whose vision is obscured by dollar signs. Oh, and did I mention regulatory capture of NIMH for <a href="http://1boringoldman.com/index.php/2014/01/19/what-2/">over $11 million</a> in funding while not producing a product worth a tinker’s damn?<i> </i><o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">In response to all this adverse commentary, the authors and the journal editors have gone to radio silence. They must be hoping it will blow over.  If anything, their silence has provoked even more searchlight questions that focus on what is happening at The University of Chicago. <o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">For instance, who is bankrolling this start-up corporation? Last summer they brought on board an executive named Yehuda Cohen who is a mover and shaker in Chicago business circles. I am sure he doesn’t work for peanuts. He set up a <a href="http://www.adaptivetestingtechnologies.com/">website</a> that must be staffed to respond to queries from consumers and professionals. Plus, the corporate office appears to be located in prime commercial space at 217 N Jefferson #600, Chicago IL 60661; phone 312-878-6490. E-mail: <a href="mailto:info@adaptivetestingtechnologies.com">info@adaptivetestingtechnologies.com</a>(from the website: you can find a picture of the neighborhood on Google). So, they are racking up significant operating expenses already. Heaven forfend that these expenses might be covered directly or indirectly by their NIMH funding! Are the responsible administrators at NIMH and at The University of Chicago looking and auditing?<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">It is also unclear whether they have a sound or even a legal business plan. Where will the high powered computing needed for their expansive applications be conducted? Do they have a computing facility at the corporate office? Or do they intend to perform the commercial computing through the NIH-supported Center for Health Statistics at The University of Chicago, which Dr. Gibbons personally directs? If so, did the University sign off on that plan? Is NIH aware of the plan?<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">In late November I asked NIH about the ownership of the data bases and algorithms on which the corporation relies for the business plan. I received a reply from NIH outlining the applicable federal policy and stating “We understand that the data are deposited and made available to the community per request through the Center for Health Statistics.” That had to be what Dr. Gibbons told them. Notice that no mention was made of the algorithms. I have replied to NIH, asking them to clarify the status of the algorithms, without which the data bases alone are of little use. I also pointed out to NIH that there is no mention of this public access option in any of the publications from these authors or on the corporate website. This situation is typical of the dissembling style we have seen before from Dr. Gibbons and Dr. Kupfer – lacking in candor and transparency.</div><br /><div class="MsoNormal">The more one looks, the more questions arise. Is The University of Chicago being taken for a ride? Is NIMH being taken for a ride? Are we all being taken for a ride? Can we please have some transparency here? Can we please have some psychometric standards here? Will the APA step up to the plate? Will NIH step up to the plate? Will The University of Chicago step up to the plate?<o:p></o:p></div><br /><br /><br />

WINDY CITY BLUES

WINDY CITY BLUESThere is an academic ethics mess brewing in the windy city… at The University of Chicago. It involves a start-up Chicago corporation, a star statistician in the medical school, seed mo…

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WHEN IS DISCLOSURE NOT DISCLOSURE?

<br /><br /><div class="MsoNormal">WHEN IS DISCLOSURE NOT DISCLOSURE? <o:p></o:p><br /><br /></div><div class="MsoNormal">Hint: When it is made by the Chairman of the DSM-5 Task Force.<o:p></o:p><br /><br /></div><div class="MsoNormal">Here is a case study in conflict of interest (COI). A remarkable <a href="http://archpsyc.jamanetwork.com/article.aspx?articleID=1780020&utm_source=Silverchair%20Information%20Systems&utm_medium=email&utm_campaign=JAMAPsychiatry%3AOnlineFirst11%2F20%2F2013">confession</a> has just appeared by a group of 5 prominent academics, writing in the journal JAMA Psychiatry. Having been outed to the Editors, they now admit to concealing pertinent financial information. One of the five is David J. Kupfer, MD, chairman of the DSM-5 Task Force and past chairman of the department of psychiatry at The University of Pittsburgh. The others are from Pittsburgh, Minnesota, and Chicago.<o:p></o:p><br /><br /></div><div class="MsoNormal">With millions in funding from NIMH, these folks have been developing new approaches to testing for anxiety and depression. The technical details are not important for this story. What matters is that they have clearly set their sights on a large market for diagnostic screening, epidemiological research, and clinical practice. They have recently published promotional reports talking up three products and projecting major applications – but before taking care of the nuts and bolts of scale development.<o:p></o:p><br /><br /></div><div class="MsoNormal">Their major <a href="http://archpsyc.jamanetwork.com/article.aspx?articleid=1389370">report</a> in JAMA Psychiatry contained a disclosure to the effect that they might at some time in the future consider commercial development of their depression scale. This disclosure was phony. We now know that, in lieu of frankly disclosing a major COI, they opted for a disingenuous, dissembling statement that was economical with the truth.<o:p></o:p><br /><br /></div><div class="MsoNormal">I thought the content of their report was sub-par, and the journal published a <a href="http://archpsyc.jamanetwork.com/article.aspx?articleid=1707797&resultClick=3">letter</a> from me to that effect. They <a href="http://archpsyc.jamanetwork.com/article.aspx?articleid=1707798&resultClick=3">responded</a> to my criticism with hand waving, and they tried to impugn me for bias related to my own (disclosed) COI. This foolish, <i>ad hominem</i> tactic aimed to divert attention from the substance of my critique – for which they had no adequate response.<o:p></o:p><br /><br /></div><div class="MsoNormal">As I am not a person who suffers fools or insults gladly, their evasive response caused me to do some checking. I quickly learned that the gang of five are shareholders in a private corporation. Before their paper was accepted by JAMA Psychiatry, the corporation was incorporated in Delaware and soon after registered to do business in Illinois. Those facts were not disclosed in the original report or in the published letter of Reply to me. These omissions were acknowledged in the notice of Failure to Report that appeared on-line today.<o:p></o:p><br /><br /></div><div class="MsoNormal">It gets worse. Other things that I learned – and that I communicated to the journal – make it clear that the corporate train had left the station in advance of the letter of Reply. For instance, a professional operations and management executive (Mr. Yehuda Cohen) had joined the corporation. He had established the corporate <a href="http://www.adaptivetestingtechnologies.com/">website</a>, where he was featured as a principal, along with the gang of five. The website also displayed a professionally crafted Privacy Policy, dated ahead of the letter of Reply. This document identified what appears to be a commercial business address for the corporation. The notice of Failure to Disclose is silent on these facts.<o:p></o:p><br /><br /></div><div class="MsoNormal">So, the published notice of Failure to Disclose still withholds pertinent information, which makes a mockery of the weasel words that they have not released any tests for commercial or professional use. Not yet, they haven’t. But they are under way, make no mistake. This prevarication creates the impression of a habitual lack of transparency. Considering that I gave the journal all this information, one has to be surprised that JAMA Psychiatry went along with this prevarication. Plus, would it have killed them to apologize for their foolish attempt to smear me, as I requested? In correspondence with me, the Editor in Chief of JAMA didn’t want to go there, and he refused to publish my letter that detailed the facts, citing the most specious of grounds. The Editor of JAMA Psychiatry has ducked for cover when I faulted him for publishing the <i>ad hominem</i> material in the first place.<o:p></o:p><br /><br /></div><div class="MsoNormal">This deplorable episode casts a pall on the repeated assurances by Dr. Kupfer that COI issues were <a href="http://www.medscape.com/viewarticle/777132">under control</a> in the DSM-5 process. If the chairman of the DSM-5 Task Force doesn’t have his own act together, then what are his assurances worth? The new instruments proposed by this corporation bear an eerie resemblance to cross-cutting dimensional measures that were promoted for DSM-5 but that didn’t make the final cut. As far as I know, Dr. Kupfer didn’t declare his interest in this corporation for scrutiny <i>vis à vis</i> DSM-5.<o:p></o:p><br /><br /></div><div class="MsoNormal">Another lesson is that even Failure to Report notices can be weasel documents. I fault the Editors of JAMA Psychiatry, Joseph Coyle, MD, and of JAMA, Howard Bauchner, MD, for the non-rigorous standard they applied to the notice of Failure to Disclose. They acquiesced in another dissembling response.<o:p></o:p><br /><br /></div><div class="MsoNormal">Yet another lesson is that all authors are accountable for the accuracy of disclosure statements. Some of these authors might claim they relied on the lead author and president of the corporation, Robert Gibbons, PhD, a statistician at The University of Chicago, to make sure everything was kosher. Big mistake – just like the infamous case of the Nemeroff-led Cyberonics – vagus nerve stimulation<a href="http://hcrenewal.blogspot.com/2006/08/money-and-medical-journals.html"> review</a> that failed to disclose that the academic authors (ahem) were paid consultants of the corporation. When your name is on the byline, be sure you cover the bases for your own protection, and don’t squawk when you are called out.<br /><br /><o:p></o:p></div><div class="MsoNormal">Finally, where is NIMH in all of this? Since when are public NIMH funds to be treated as commercial seed money? Who actually owns the algorithms and data bases on which the Gibbons corporation relies for its commercial aspirations? Why are they not publicly accessible? Is Thomas Insel on top of this?<o:p></o:p></div><div class="MsoNormal"><br /></div><br /><div class="MsoNormal"><br /></div>

WHEN IS DISCLOSURE NOT DISCLOSURE?

WHEN IS DISCLOSURE NOT DISCLOSURE? Hint: When it is made by the Chairman of the DSM-5 Task Force.Here is a case study in conflict of interest (COI). A remarkable confession has just appeared by a grou…

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PROFESSOR NEMEROFF GOES TO LONDON

<br /><div class="MsoNormal">THREE STRIKES AND …<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">Professor Charles Nemeroff is being honored today in London. He will deliver a high profile lecture at the Institute of Psychiatry, King’s College London, a component of The University of London. IoP and its associated Maudsley Hospital have long been at the forefront of psychiatric research in Britain. The occasion today is the establishment of a new program on mood disorders, and Professor Nemeroff’s topic will be “The Neurobiology of Child Abuse: Treatment Implications.” He will be introduced by Professor Allan Young and the vote of thanks will be proposed by Professor Sir Robin Murray, a former dean of IoP-Maudsley. In the chair will be Professor Carmine Pariante, a onetime colleague of Professor Nemeroff. The current dean, Professor Shitij Kapur, seems to be staying in the background.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">On this side of the pond we are depressingly familiar with Professor Nemeroff. He is the poster boy for conflict of interest in academic psychiatry. I will not rehearse here all the ethics issues in which he has been compromised over the past 15 years. Suffice it to say that as a result of those issues he was dismissed from his departmental chairmanship at Emory University; he was required to resign as editor of the journal <i>Neuropsychopharmacology</i>; he was banned from involvement in NIH grants at Emory University for 2 years; he received an unprecedented sanction from the Ethics Committee and Council of The American College of Neuropsychopharmacology (ACNP), which included a 2-year ban on participating in ACNP meetings and committees; the Accreditation Council on Continuing Medical Education (ACCME) issued a punitive sanction on a program that he directed, finding commercial bias and requiring the program to be withdrawn; and he was referred by Senator Charles Grassley of the US Senate Finance Committee to the Inspector General of the US Department of Health and Human Services for investigation of grounds for criminal charges. <o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">The administrators of IoP-Maudsley apparently ignored these warning signals when they announced over a month ago that they had tapped Professor Nemeroff for today’s honorific lectureship. Many other professionals were shocked, however, and they voiced their disapproval widely – <a href="http://www.madinamerica.com/wp-content/uploads/2013/06/Nemeroff-letter.pdf">directly to the IoP</a>, in the <a href="http://www.independent.co.uk/life-style/health-and-families/health-news/honoured-in-britain-the-us-psychiatrist-who-took-12m-from-drug-companies-8654535.html">mainline press</a>, in the <a href="http://www.bmj.com/content/346/bmj.f3256/rr/648024">British Medical Journal</a>, in <a href="http://criticalpsychiatry.blogspot.com/2013/06/the-ethical-corruption-of-academic.html">on-line comments</a>, and even in a <a href="http://vimeo.com/68299094">video critique</a>. University Diaries ran a critical <a href="http://www.margaretsoltan.com/?p=40236">commentary</a>, as did the respected weblogs <a href="http://www.pharmalive.com/tarnished-image-psychiatrists-square-off-over-a-nemeroff-lecture">Pharmalot</a> and <a href="http://1boringoldman.com/index.php/2013/06/13/character-is-pervasive/">1Boringoldman</a>. Significantly, the letter to British Medical Journal came from a psychiatrist affiliated with IoP itself.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">The IoP <a href="http://freepdfhosting.com/5be73b1bf4.pdf">responded</a> with typical academic stonewalling. Professor Carmine Pariante and Professor Allan Young wrote to the Critical Psychiatry Network, defending the decision to engage Professor Nemeroff. Unfortunately for them, their letter contained 2 fatal mistakes. First, they highlighted the perceived academic distinction of Professor Nemeroff as justification for his selection, thereby confusing an ethics issue with a competency issue. Who cares about Professor Nemeroff’s supposed expertise? When such a compromised individual is given honorific status it sends the wrong message to junior faculty members and to trainees. It also sends the wrong message about the institution's values, as I have discussed <a href="http://hcrenewal.blogspot.com/2010/12/impeachment-its-about-institution-not.html">before</a>. 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.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">The second fatal error in the IoP response was to cast the issue in terms of academic freedom. That claim is rank hypocrisy. The protests are ethics complaints, not disagreements about content or professional turf. Professor Nemeroff was impeached by his peers for ethical lapses, as the record of sanctions clearly shows. That is what sparked the protests. The IoP administrators are displaying glass eyes and tin ears.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">We should also question the scientific judgment of the IoP administrators. Treatment implications of child abuse is a featured focus of Professor Nemeroff’s lecture. How much do the IoP administrators really know about Professor Nemeroff’s work in this area? Do they know how little he has published in this area? Do they know that he is on the public record with at least 2 instances of misrepresenting his work in this area?<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">Professor Nemeroff’s sole publication of original data in this area appeared in 2003 (<a href="http://www.ncbi.nlm.nih.gov/pubmed/14615578">PubMed ID 14615578</a>). 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 (see PNAS 2005 November 8;102(45):16530) because the data concerning reduction of Hamilton depression scores had been misrepresented. <o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">Notwithstanding the retraction, Professor Nemeroff discussed the retracted data without the necessary qualification in a 2008 Continuing Medical Education program – the same one that was <a href="http://hcrenewal.blogspot.com/2009/10/nemeroff-seroquel-and-accme.html">sanctioned by ACCME</a>. Use of retracted material in this way is inconsistent with ethically grounded teaching. It also is inconsistent with <a href="http://www.fda.gov/oc/op/goodreprint.html">FDA standards</a> for scientific reference publications. Among other requirements, the FDA standards state that scientific reference publications may not <i>“</i><i><span lang="EN">be false or misleading, such as a journal article or reference text… <b>that has been withdrawn by the journal or disclaimed by the author</b>, or…”</span></i><span lang="EN"> </span>Professor Nemeroff then went further, stating in the video record that a history of childhood abuse or neglect “predicts poor outcome… particularly to pharmacotherapy.” That claim is outright false. The data simply do not support that claim.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">Professor Nemeroff repeated these same misrepresentations <a href="http://www.veomed.com/grandrounds/archive&vid=817631&gnr=824342">on the video record</a> a second time in January 2012 when he presented Psychiatry Grand Rounds at New York University. Once again Professor Nemeroff displayed sleight of hand in palming off a nonsignificant difference as both statistically and clinically significant. To reiterate, Professor Nemeroff’s own data do not show a statistically or clinically significant difference between chronically depressed patients with and without a history of child abuse in their responses to drug or to CBASP.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">The question for today is, will Professor Nemeroff repeat these misrepresentations in his lecture at the IoP-Maudsley? Should he do that, then the 3-strike rule needs to be invoked. I nominate the administrators at IoP-Maudsley for the job of lowering the boom finally on Professor Nemeroff. That would be one way they might redeem themselves in this fiasco.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">Oh, and by the way, Professor Nemeroff has apparently done nothing more in this area since the 2003 partially retracted secondary analysis of an earlier study. But others have been looking at his claims and have not confirmed them – see, for instance the <a href="http://www.ncbi.nlm.nih.gov/pubmed/22428942">Canadian study</a> that found no difference in response rates to pharmacotherapy or cognitive behavior therapy in patients with and without histories of severe childhood maltreatment (PubMed ID 22428942). Will Professor Nemeroff acknowledge this non-confirmation of his narrative when he speaks today at the IoP-Maudsley? We are agog.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">If the administrators of IoP-Maudsley wish to continue defending their selection of Professor Nemeroff as a world expert on the treatment implications of child abuse, then who am I to argue? I don’t need to argue… the record speaks for itself.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">One final point: the IoP <a href="http://freepdfhosting.com/5be73b1bf4.pdf">response</a> to the Critical Psychiatry Network stated that Professor Nemeroff “will not be presenting any research that was funded by commercial companies or affected by commercial implications. Obviously, he will be declaring any relevant conflicts of interest prior to his lecture.” The administrators at IoP should be aware that Professor Nemeroff’s data on treatment implications of child abuse (such as they are) do, in fact, come from a commercially sponsored clinical trial. I would also bet dollars to donuts that Professor Nemeroff declares no relationship to Bristol Myers Squibb, the sponsor of that trial.</div><div class="MsoNormal"><o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">What are the larger lessons of this new <i>affaire Nemeroff</i>? Academic institutions like IoP-Maudsley need spine and due diligence to maintain decent standards and to put the hand wavers where they belong – not on center stage. Raise the bar, chaps!<o:p></o:p><br /><br /><u>BERNARD CARROLL</u><br /><u><br /></u><div class="MsoNormal"><b><u>UPDATE 06-18-2013<o:p></o:p></u></b></div><div class="MsoNormal"><br /></div><div class="MsoNormal">We are waiting for a response from the Institute of Psychiatry… it could be a long wait. We have learned that Professor Nemeroff was unwilling to make publicly available the slides he used in his lecture yesterday. Hmmm.<o:p></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">Meanwhile, I should clear up some potential confusion about the data in Professor Nemeroff’s <a href="http://www.ncbi.nlm.nih.gov/pubmed/14615578">2003 publication</a> that I discussed yesterday. When I said the data showed no significant difference in response to cognitive behavior therapy (CBASP) between patients with and without early life trauma, I said that because Professor Nemeroff had made no claim that there was a difference. He made a variety of other claims, but not this one. I took this to mean that he had looked for a significant difference but didn’t find one. It is not possible for anyone to make an independent determination of what he found because he did not report the data transparently – there was no positive statement of sample sizes for different treatments, for example, and the remission rates were not consistently reported: some were stated numerically while others were only displayed graphically. For what it is worth, there might actually be a significant difference in response to CBASP between patients with and without early life trauma. We just cannot be sure. Let the record stand corrected. Maybe Professor Nemeroff can clear that up?<o:p></o:p></div><div class="MsoNormal"><br /></div><div style="margin-bottom: .0001pt; margin: 0in;">None of this alters the fact that Professor Nemeroff’s data show no significant difference in response to nefazodone between patients with and without early life trauma. And, none of this alters the misrepresentations by Professor Nemeroff that I discussed yesterday. In the <a href="http://hcrenewal.blogspot.com/2009/10/nemeroff-seroquel-and-accme.html">sanctioned CME presentation </a>in 2008 he positively stated on the video record that a history of childhood abuse or neglect “predicts poor outcome… particularly to pharmacotherapy.” That claim is outright false. The data simply do not support that claim, and, once again, he made no such claim in the 2003 publication.<o:p></o:p></div><div style="margin-bottom: .0001pt; margin: 0in;"><br /></div><div style="margin-bottom: .0001pt; margin: 0in;">Likewise, in the 2012 <a href="http://www.veomed.com/grandrounds/archive&vid=817631&gnr=824342">Grand Rounds</a> presentation at NYU, Professor Nemeroff positively stated that patients with chronic depression but without a history of childhood trauma “did better with drug than with CBASP.” That also is a false statement (see Figure 1B of the 2003 publication). There is no significant difference and none was claimed in the paper.<o:p></o:p></div><div style="margin-bottom: .0001pt; margin: 0in;"><br /></div><div style="margin-bottom: .0001pt; margin: 0in;">Meanwhile, in both these misleading presentations that are on the video record Professor Nemeroff used the retracted material that I mentioned yesterday. He used it in classic hand waving fashion to embellish his narrative, but he used it without the required qualification that was given in his retraction notice!<o:p></o:p></div><div style="margin-bottom: .0001pt; margin: 0in;"><br /></div><div style="margin-bottom: .0001pt; margin: 0in;">Aren’t we all justified in asking the Institute of Psychiatry to release Professor Nemeroff’s slides from yesterday’s much publicized lecture? <o:p></o:p></div><div style="margin-bottom: .0001pt; margin: 0in;"><br /></div><br /><div style="margin-bottom: .0001pt; margin: 0in;"><u>BERNARD CARROLL<span style="font-size: medium;"><o:p></o:p></span></u></div></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><br /></div>

PROFESSOR NEMEROFF GOES TO LONDON

THREE STRIKES AND …Professor Charles Nemeroff is being honored today in London. He will deliver a high profile lecture at the Institute of Psychiatry, King’s College London, a component of The Univers…

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WALK THE WALK

<br /><br /><div class="MsoNormal"><o:p><u>WALK THE WALK</u></o:p></div><div class="MsoNormal"><br /></div><div class="MsoNormal">For some time a jeremiad theme has been dominant in the psychiatric sector of the <a href="http://hcrenewal.blogspot.com/2009/01/academic-industrial-complex.html">academic-industrial complex</a>. Blockbuster psychiatric medications are going off patent, the pipeline is viewed as alarmingly empty, and several corporations are scaling back or even abandoning their research programs in this area. Analyses of the reasons range from the <a href="http://www.ncbi.nlm.nih.gov/pubmed/17080187">enlightened</a> to the <a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=22837348">pragmatic</a> to the <a href="http://www.psychiatrictimes.com/all/editorial/psychiatrictimes/pdfs/KrystalPresidentsLetter2012.pdf">pedantic</a> to the <a href="http://www.thecarlatcmeinstitute.com/blog/2011/08/has-stephen-stahl-gone-off-the-deep-end-you-decide/">foolish</a>. Everyone predicts that things will turn bleak in academic clinical research if the corporate spigot is turned off.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">Lost in the wailing is a clear understanding that the defecting corporations are acting out of their own enlightened self interest. For 50 years, no fundamentally incisive innovations have occurred, so the defectors are telling the academics to get their act together in respect of better understanding disease mechanisms. Trouble is, too many academic clinical investigators have devolved into key opinion leaders promoting corporate marketing messages at the expense of generating original clinical science. Now they are squawking about being caught with their pants down.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">The latest academic psychiatrist to opine about this issue is Steven Hyman at Harvard Medical School. In a new commentary that has just <span style="background-color: white; background-position: initial initial; background-repeat: initial initial;"><a href="http://www.dana.org/news/cerebrum/detail.aspx?id=41290">appeared</a></span>, Dr. Hyman talks up his favorite theme of translational medicine, which sounds lovely until you perceive that he has no contemporary examples of same in psychopharmacology. It’s all airy rhetoric. Dr. Hyman is not just a Harvard professor – he is a former Director of the National Institute of Mental Health (NIMH). Then he was Provost at Harvard under President Larry Summers. Now he is Director of a psychiatric research center at Harvard. </div><div class="MsoNormal"><br /></div><div class="MsoNormal">Someone else who noticed Dr. Hyman’s new <span style="background-color: white; background-position: initial initial; background-repeat: initial initial;"><a href="http://www.dana.org/news/cerebrum/detail.aspx?id=41290">commentary</a></span> is our fellow blogger Dr. John M. (Mickey) Nardo across at <span style="background-color: white; background-position: initial initial; background-repeat: initial initial;"><a href="http://1boringoldman.com/">1Boringoldman.com</a></span>. His take on the Hyman piece is right on target. Basically, the Hyman commentary is a hortatory fantasy that we can all do better by buying in to his vision of interdisciplinary research, pooling the efforts of academia, industry, and government. Problem is, his vision hasn't worked so far. Here is an example.</div><div class="MsoNormal">   </div><div class="MsoNormal" style="margin-bottom: .0001pt; margin-bottom: 0in;">Towards the end of his term as NIMH Director, Dr. Hyman set the ball rolling for new centers cast in his mold of translational research. Dr. Nardo <span style="background-color: white; background-position: initial initial; background-repeat: initial initial;"><a href="http://1boringoldman.com/index.php/2013/04/05/whither-the-crisis/">mentioned</a></span> “… a bunch of centers that haven’t produced very much.” The model of such failed centers is the one that existed at Emory University under the direction of Charles Nemeroff. It was called the Emory-GlaxoSmithKline-NIMH Collaborative Mood Disorders Initiative 5U19MH069056 (Principal Investigator Charles Nemeroff). It was conceived with all the right buzzwords about innovative models of drug discovery and translational benefit for patients through partnerships of academic centers with commercial drug makers (the Request for Applications (RFA) actually used this language). From the start, the Initiative was poorly managed and it never lived up to its billing. </div><div class="MsoNormal" style="margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="margin-bottom: .0001pt; margin-bottom: 0in;">Annual Progress Reports from the Initiative to NIMH, obtained through a FOIA request, reveal unacceptably low scientific productivity, and lack of leadership to promote the intended scientific synergies among laboratories. When I assessed the overall productivity of this project four years after the end of the first 5-year funding period, it was apparent that the U.S. taxpayer received little value for the $5.3 million investment by NIMH. Only 7 original scientific publications could be attributed to the federal support (that count excludes a host of potboiler review articles and other academic padding). Five of these 7 originated from a single participating laboratory at Emory. The NIMH component, under Dennis Charney, also was a serious underperformer.</div><div class="MsoNormal" style="margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="margin-bottom: .0001pt; margin-bottom: 0in;">The collaborating drug company GlaxoSmithKline obtained valuable preclinical information from the Emory laboratories, much of which has never been published even though federal funding supported the work. If the data are being treated as confidential proprietary information by GSK, then that posture would be contrary to the spirit of the original RFA. Maybe GSK just decided it was worthless data. In addition, GSK benefited from the conduct of a Phase II clinical trial of one of their candidate drugs in posttraumatic stress disorder (PTSD), even though this study returned a negative result. Even worse, the trial did not meet the stated criteria of the RFA. It was not based on any well founded theory of PTSD. Instead, it was a routine, exploratory study of a new compound. Because the study design did not permit strong inference, nothing substantive was learned from the negative result. This Phase II trial could have been performed better and less expensively by GSK itself as a normal business activity. GSK certainly did not need scarce NIMH dollars for this routine, early Phase II trial. The Emory-GSK-NIMH Initiative added no scientific value.</div><div class="MsoNormal" style="margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal">Notwithstanding the clear evidence of under-productivity, NIMH under Director Thomas Insel, MD, continued the Initiative for all 5 years of the original funding period, and then renewed the Initiative for a second 5 year period at an increased funding level under a new P.I., Helen Mayberg, M.D. Dr. Mayberg is a respected clinical scientist, but she is not a psychiatrist, she is not a psychopharmacologist, and she has no track record of research in the priorities announced by the RFA. What actually is going on? Did NIMH just hand a favor to Dr. Insel’s former employer, Emory University, to the tune of another $6 million?</div><div class="MsoNormal"><br /></div><div class="MsoNormal">One lesson of this episode is that the chatter by federal scientific administrators (Hyman, Insel) about translational research strategies and innovative models of drug discovery is mostly vacuous rhetoric. The RFA was an imprudent conceit to begin with, having no base in solid clinical science, and this expensive Initiative failed catastrophically to meet its grandiose objectives. It is ironic that Dr. Hyman presumes to scold and sermonize to the field yet again about translational research, as it was he who set the ball rolling in the first place for the disastrous Emory-GlaxoSmithKline-NIMH Collaborative Mood Disorders Initiative. Last time I looked, nobody has been held accountable for the failure of the Initiative. Where is NIMH Director Thomas Insel when we need him to set standards of accountability and ethics?</div><div class="MsoNormal"><br /></div><div class="MsoNormal">So, the next time you hear academic psychiatrists lamenting how bad it is, remind them about this scandalous example of waste and mismanagement of federal research funding. Cleaning up cesspools like this would be a step to unblocking the drug development pipeline. And we need leaders who walk the walk, not just talk the talk.</div><div class="MsoNormal"><br /></div>

WALK THE WALK

WALK THE WALKFor some time a jeremiad theme has been dominant in the psychiatric sector of the academic-industrial complex. Blockbuster psychiatric medications are going off patent, the pipeline is vi…

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DOES AMERICAN PSYCHIATRY MATTER?

<br />DOES AMERICAN PSYCHIATRY MATTER?<br /><br />The blogmeister of 1boringoldman.com has done it again. A semi-retired psychiatrist in rural Georgia, he has done more than anyone to document the follies and the ethical challenges of contemporary American psychiatry. His site is required reading for all who care about behavioral health issues. <br /><br />In his <a href="http://1boringoldman.com/index.php/2012/11/02/cest-la-vie/">latest posting</a> he compared the domain of American psychiatry to Yugoslavia. Cast Melvin Sabshin as Marshal Tito. Sabshin was the medical director of the American Psychiatric Association in the late 1970s, the period leading up to DSM-III. Tito and Sabshin each strong-armed a confederation of sorts but failed to deal with the conflicts beneath the surface. Both leaders were faced with the prospect of their domains disintegrating – Tito’s at the hands of Moscow and Sabshin’s at the hands of insurance companies. Both persuaded wary stakeholders to sign on to a compromise, for want of anything better and fearing a worse outcome.<br /><br />The domain of psychiatry hasn’t yet reached the stage of ethnic cleansing and genocide that we saw in Yugoslavia after Tito’s death, but it is well on the way. One only has to look at the vicious response of the American Psychiatric Association leaders to Allen Frances and other critics of DSM-5. The APA president in 2009, Alan Schatzberg from Stanford, went out of his way to <a href="http://www.psychi%20imes.com/dsm-5/content/article/10168/1425806atrict">smear</a> Dr. Frances and Robert Spitzer, the architects of DSM-IV and DSM-III because he had no credible scientific response to their criticisms of the directions DSM-5 is taking. He was joined in this low act by David Kupfer and Darrel Regier, who are directing the DSM-5 effort. Where is the comity, Comrades? Where are the shared values? Why is the APA holed up in a bunker?<br /><br />Then we have the unsavory sight of the APA lawyers <a href="http://hcrenewal.blogspot.com/2012/01/self-inflicted-damage.html">threatening</a> a blogfrauchen in the U.K. with a SLAPP lawsuit for alleged infringement on the APA’s intellectual property – as though the APA owns psychiatric classification! Talk about chutzpah. So now the confederation Sabshin cobbled together is breaking up and the stakeholders are starting to go their separate ways – psychologists, counselors, social workers, patient advocacy groups, even many psychiatrists. Christopher Lane in <a href="http://www.psychologytoday.com/blog/side-effects/200912/american-psychiatry-is-facing-civil-war-over-its-diagnostic-manual">Psychology Today</a> has said American psychiatry is facing “Civil War” over its diagnostic manual. Even an international psychiatric journal like British Journal of Psychiatry is <a href="http://bjp.rcpsych.org/content/201/4/334.full">distancing itself</a> from DSM-5 and there is talk of abandoning DSM-5 for the next ICD classification.<br /><br />Why is American psychiatry self destructing? Because the grand bargain forged in 1980 with DSM-III was a sham from the get-go and the promised benefits of diagnostic reliability have not materialized. They knew all along that reliability was a poor substitute for validity, but they settled for half a loaf. That compromise led us into the <a href="http://hcrenewal.blogspot.com/2009/04/in-defense-of-psychiatric-diagnoses-and.html">epistemologic quagmire</a> of today, where there is no solid ground for clinical decisions or clinical research progress or drug development. A stunning absence from the DSMs to date is any statement about treatment. That compromise also led us to diagnostic inflation, which Pharma embraced. Pharma quickly filled the vacuum with <a href="http://www.ncbi.nlm.nih.gov/pubmed/15169734">experimercials</a> that <a href="http://hcrenewal.blogspot.com/2012/10/when-clinical-trials-are-meant-for.html">pretended</a> to be real clinical science, and in the process diverted precious clinical research infrastructure away from genuinely important questions. Just look at the clinical trials er, experimercials, mill operating out of Massachusetts General Hospital at Harvard University.<br /><br />What lies ahead? Stakeholders are going to vote with their feet. DSM-5 is likely to be a footnote in the history of psychiatric classification. The APA will become even less relevant than it is today, much like the American Medical Association, which now commands the loyalty of maybe <a href="http://mediamatters.org/research/2009/06/15/nbcs-guthrie-falsely-suggests-ama-represents-th/151182">30% of U.S. physicians</a>. Mel Sabshin will turn in his grave, the APA will lose revenue, ICD-11 will become the dominant classification of psychiatric disorders, and the quagmire will continue until a new synthesis arises from the ashes. If Yugoslavia is any kind of model, don’t hold your breath.<br /><br />

DOES AMERICAN PSYCHIATRY MATTER?

DOES AMERICAN PSYCHIATRY MATTER?The blogmeister of 1boringoldman.com has done it again. A semi-retired psychiatrist in rural Georgia, he has done more than anyone to document the follies and the ethic…

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Harvard Psychiatry Fails Again

HARVARD PSYCHIATRY FAILS AGAIN <br /><br />About a year ago I remarked upon the ethical tone deafness that characterizes Harvard psychiatry. It is bad enough that Harvard-MGH is the home of Joseph Biederman, MD, with whom Senator Grassley had so much fun a while back. Biederman is still <a href="http://www.margaretsoltan.com/?p=34605">in the news</a>. It is also the home of Andrew Nierenberg, MD, who was rash enough to take on <a href="http://www.nybooks.com/articles/archives/2011/jun/23/epidemic-mental-illness-why/?pagination=false">Marcia Angell</a> in the New York Review over her well founded criticisms of the hyping and misuse of psychiatric drugs. In <a href="http://www.nybooks.com/articles/archives/2011/aug/18/illusions-psychiatry-exchange/">response</a>, Dr. Angell handed Dr. Nierenberg his head. <br /><br />Biederman and Nierenberg are not the only ones. When I <a href="http://hcrenewal.blogspot.com/2010/12/impeachment-its-about-institution-not.html">called</a> one of the senior Harvard professors, Carl Salzman, MD, to task for signing up a pair of compromised key opinion leaders as speakers in his annual Psychopharmacology Master Class last spring, I hoped the ensuing negative publicity would persuade him to go in a different direction next time. <br /><br />No such luck! Today I saw the <a href="http://cme.hms.harvard.edu/index.asp?SECTION=CLASSES&ID=03224280&SO=N">flyer</a> for the 2012 Harvard Psychopharmacology Master Class. The list of speakers is virtually unchanged from a year ago. There is Charles Nemeroff. There is Alan Schatzberg. Both were outed by Senator Grassley’s investigation in 2008, and both were subjected to major administrative sanctions, by Emory University and by Stanford University. Other people now occupy the departmental leadership chairs they held in 2008. There also is a group of other <a href="http://cme.hms.harvard.edu/index.asp?SECTION=CLASSES&ID=03224280&SO=N">key opinion leaders</a> who appear content to endure the taint of sharing the podium with the compromised Nemeroff and the compromised Schatzberg. What are they thinking? <br /><br />For that matter, what is the course director Carl Salzman thinking? A year back he said Nemeroff and Schatzberg would give great talks and that he would ensure they were objective and impartial. That’s not the point. The point is that they brought dishonor on our field, and for Harvard Medical School to give them this platform amounts to compartmentalizing information in service of their public rehabilitation. To repeat what I said a year ago, Adolph Hitler also gave a lot of speeches that received rave reviews, and compartmentalized information was widespread in the nation of Germany between 1928 and 1945. The best one can say about the upcoming course is that Biederman and Nierenberg are not on the program. <br /><br />The Augean stables of psychiatry, at Harvard and nationwide, will not be flushed clean by the Carl Salzmans of our field, quibbling over legal technicalities while failing to see the ethical elephant in the living room. <br /><br />For how long will the grownups at Harvard Medical School allow this farce to continue?

Harvard Psychiatry Fails Again

HARVARD PSYCHIATRY FAILS AGAIN About a year ago I remarked upon the ethical tone deafness that characterizes Harvard psychiatry. It is bad enough that Harvard-MGH is the home of Joseph Biederman, MD, …

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SELF INFLICTED DAMAGE

SELF INFLICTED DAMAGE <br /><br />The American Psychiatric Association (APA) is in the news again for bad public relations: worse than bad, actually – appalling. Locked in a bunker mentality, they have moved to stifle advance criticism of their flagship initiative, DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition), which is a work in progress. Lawyers for the APA have threatened the owner of a UK blog that served as a discussion forum for issues affected by DSM-5 and other, international psychiatric classifications. The blog, named <a href="http://dsm5watch.wordpress.com/">dsm5watch</a> was considered authoritative and accurate. If you go to this site now you will find that it has been deleted.<br /><br />As <a href="http://www.psychologytoday.com/blog/dsm5-in-distress/201201/is-dsm-5-public-trust-or-apa-cash-cow">recounted</a> this week by Allen Frances, MD, the editor of the last published DSM edition, the blog’s owner, Suzy Chapman, told him, <i>”On December 22, I was stunned to receive two emails from the Licensing and Permissions department of American Psychiatric Publishing, claiming that the domain name my site operates under was infringing upon the DSM 5 trademark in violation of United States Trademark Law and that my unauthorized actions may subject me to contributory infringement liability including increased damages for willful infringement. I was told to cease and desist immediately all use of the DSM 5 mark and to provide documentation within ten days confirming I had done so." </i><br /><br /><i>"Given my limited resources compared with APA's deep pockets, I had no choice but to comply and was forced to change my site's domain name to <a href="http://dxrevisionwatch.wordpress.com/">dxrevisionwatch</a>. Hits to the new site have plummeted dramatically and it will take months for traffic to recover - just at the time when crucial DSM 5 decisions are being made."</i> <br /><br />In effect, the APA, acting not through its medical or scientific officers but through its wholly owned publishing house, has attempted a SLAPP maneuver. SLAPP is the acronym for strategic lawsuit against public participation. What kind of leadership does this signal in a major professional organization? <br /><br />The normal remit of professional medical societies is stewardship of professional values and ethics. That is why these societies are accorded deference and respect on matters of clinical guidelines, health policy and public education. Even when, like the Institute of Medicine of the National Academy of Sciences, they <a href="http://hcrenewal.blogspot.com/2009/04/institute-of-medicine-report-on.html">tolerate compromised members</a>, they can generally hope to retain the public trust. <br /><br />One reason for this assurance is that they are expected <i>as a matter of professional duty</i> to avoid conflicts of interest – personal and financial. The APA, however, has an enormous conflict in this case: it counts on millions of dollars in revenue from sales of the DSM volumes and it is under siege currently for perceived scientific and clinical weaknesses of the DSM-5 that is due to be released next year. Professional criticism is running so high that over 10,000 interested parties have signed a petition for the APA to reconsider planned changes. There is even talk of abandoning DSM-5 in favor of the ICD system (International Classification of Diseases), which is a WHO initiative. <br /><br />The APA doesn’t own psychiatric classification and diagnostic criteria. When the field allows the APA to take the initiative for revisions of the DSM, it is with the understanding that the work will be conducted in the public interest rather than in the commercial interest of the APA itself, which is said to derive over $5 million annually in profits from DSM sales. The public interest and the public trust are served by transparency and open discussion, not by contrived SLAPP threats. <br /><br />It is bad enough that the APA resorts to this legal artifice to stifle public discussion. When they do it through their lawyers and business entities rather than through their medical and scientific officers, they sink to a lower level yet. The parallels with corporate sleaze that we have discussed so often on this blog are obvious. For shame.

SELF INFLICTED DAMAGE

SELF INFLICTED DAMAGE The American Psychiatric Association (APA) is in the news again for bad public relations: worse than bad, actually – appalling. Locked in a bunker mentality, they have moved to s…

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Quis Custodiet Ipsos Custodes? Redux

Revised HHS Rules for Conflict of Interest Fall Short <br /><br />This morning NIH Director Dr. Francis Collins announced <a href="http://freepdfhosting.com/3dde31520d.pdf">revisions</a> to the existing 1995 regulations on objectivity in research that is funded by the Public Health Service. The focus is on significant financial interests (SFI) and on financial conflicts of interest (FCOI). The regulations illustrate the 3-way dance involving academic institutions (the grantees), NIH (the grantor) and academic scientists (the investigators). Thanks to Senator Grassley (R-Iowa) and his investigator Paul Thacker, headlined revelations in recent years about unacceptable management of FCOI at places like Stanford (Alan Schatzberg), Emory (Charles Nemeroff) and Harvard (Joseph Biederman) forced these revisions of the NIH regulations. <br /><br />The general initial reaction to the new rules has been critical – <a href="http://www.pharmalot.com/2011/08/nih-issues-new-conflict-of-interest-rules/">here</a> and <a href="http://pogoblog.typepad.com/pogo/2011/08/the-national-institutes-of-health-new-ethics-rules-a-swing-and-a-miss.html">here</a>, for instance. Many stakeholders had urged the NIH to require that institutions make the disclosed FCOI of their investigators available on a public website. Dr. Collins had intimated that we could expect to see this change, so there is consternation that it somehow became derailed by institutional lobbying in recent months. The stated concern was that institutions would feel burdened by the need to maintain these data bases. Instead, if citizens wish to inquire about FCOI involving PHS-derived research funding, they will need to write to the institution, which is obliged to respond within 5 days. That’s not exactly user friendly. POGO today made the smart <a href="http://pogoblog.typepad.com/pogo/2011/08/the-national-institutes-of-health-new-ethics-rules-a-swing-and-a-miss.html">suggestion</a> that the data could easily be attached to information about awarded funds on the <a href="http://projectreporter.nih.gov/reporter.cfm">NIH RePORTER</a> website, that already exists. <br /><br />A second failing is that the revised regulations do not close the regulatory loophole through which Charles Nemeroff strolled when he moved from Emory to the University of Miami. We covered that incident <a href="http://hcrenewal.blogspot.com/#uds-search-results">several times</a> on this blog last year. Though Nemeroff was under a 2-year sanction and banned from participating in NIH-funded research at Emory, his friend Thomas Insel, Director of NIMH, assured the dean of the medical school at Miami that Nemeroff was in good standing to apply for NIH funding when he moved from Emory. To underline the point, Insel displayed the bad judgment of appointing Nemeroff to 2 new NIMH review committees. <br /><br />Do today’s revised regulations prevent a repeat of this administrative travesty? No, they don’t. There is some mention of ensuring oversight if a sanctioned investigator wishes to transfer a grant to a new institution, but nothing to prevent the Nemeroff-Insel dance from being repeated. Here is the relevant section of today’s <a href="http://freepdfhosting.com/3dde31520d.pdf">announcement</a> (page 89): <br /><br /><em>We did, however, agree with one respondent that it would be helpful to clarify, in the grants context in particular, that institutional sanctions against an Investigator can travel with the Investigator upon his or her transfer to another Institution. Specifically, we have revised 42 CFR 50.606, paragraph (a), as follows: “If the failure of an Investigator to comply with an Institution’s financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Institution shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS-funded research project. The PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.” <br /><br />This revision is intended to reference the range of options for the PHS Awarding Component to consider, depending on the specific circumstances at issue. For example, PHS may decide to initiate government-wide suspension or debarment of the Investigator under 2 CFR Part 376; or to use enforcement measures under 45 CFR 74.62, e.g., perhaps to make the approval of a transfer contingent upon the former Institution’s disclosure of the corrective action- including the specific sanctions against the Investigator- to the new Institution; and/or to use special award conditions under 45 CFR 74.14, e.g., perhaps to make the new Institution agree to take the same or similar action against that Investigator or explain to the PHS Awarding Component in writing why such action was not taken and what alternative measures will be used to ensure compliance.</em><br /><br />What’s wrong here? Everything is optional; everything is discretionary; everything is contextual – that is a formula for NIH and the academic institutions to just look the other way. And if a Nemeroff decides just to relocate without transferring a grant then he is free to start reapplying again right away. Miami would not be required to continue applying the Emory sanction banning him for 2 years from involvement in federal grants. The PHS Awarding Component (NIMH in this case) may or may not get involved, or it may pass the buck to the new institution. So what has changed? If it is left up to compromised federal bureaucrats like Thomas Insel, and institutional administrators like Pascal Goldschmidt at Miami, then nothing has changed. It's business as usual, folks. <br /><br />Dr. Collins, you have not done what you set out to do. Too bad. <br /><br /><br />

Quis Custodiet Ipsos Custodes? Redux

Revised HHS Rules for Conflict of Interest Fall Short This morning NIH Director Dr. Francis Collins announced revisions to the existing 1995 regulations on objectivity in research that is funded by th…

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...THEM OR YOUR LYING EYES?

…THEM OR YOUR LYING EYES? <br /><br />A few days ago I <a href="http://hcrenewal.blogspot.com/2011/04/who-you-gonna-believe.html">discussed</a> stonewalling by the American Psychiatric Association over charges that they were partners in a ghostwritten textbook. The issue resonated with many people, including <a href="http://carlatpsychiatry.blogspot.com/2011/04/like-bad-penny-nemeroffschatzberg.html">Daniel Carlat</a>, <a href="http://1boringoldman.com/index.php/2011/04/05/still-on-the-radar-screen/">John Nardo</a>, <a href="http://pogoblog.typepad.com/pogo/2011/04/ghostwriting-controversy-haunting-the-american-psychiatric-association.html">the POGO blog</a>, <a href="http://alison-bass.blogspot.com/2011/04/tale-of-censorship-and-secrecy-starring.html">Alison Bass</a>, <a href="http://www.pharmalot.com/2011/04/american-psychiatric-association-and-ghostwriting/">Ed Silverman</a>, and others. The APA has not seen its way clear to releasing key documents that might clear up the charges. By stonewalling, the APA just does more damage to its image and credibility. They come across as uninterested in transparency, and they appear to be fighting a rearguard action to defend the indefensible. <br /><br />What kind of key documents could the APA have released? In our <a href="http://pogoblog.typepad.com/pogo/letter-to-apa-20110128.html">letter</a> last January we suggested several, including the contract involving the American Psychiatric Press, the medical communications company (Scientific Therapeutics Information, Inc. or STI), the grant-giving drug company, the professional writers, and the nominal authors of the allegedly ghostwritten book. What might the contract have told us? Well, it probably looks a lot like <a href="http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/19980403STIContract.pdf">this contract</a>, which involves the same medical communications company, the same drug company, and one of the same professional writers, Sally Laden. It was developed right around the same time as the textbook was planned, and it is for a ghostwritten journal article promoting the infamous Paxil Study 329. Look carefully at <a href="http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/19980403STIContract.pdf">this contract </a>and you will be in no doubt about who did the essential work of writing and framing the article or about whether the corporation had control over the content. Now ask yourselves, if the contract for the textbook <i>doesn’t</i> look like this then why ever would the APA want to suppress it? That behavior just makes people conclude that the contract for the textbook <i>does</i> look like <a href="http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/19980403STIContract.pdf">this contract </a>and that the APA knows it has plenty to hide. <br /><br />A first principle of cover-ups and stonewalling is that everyone needs to be on the same page with the cover story. When they are not, the façade collapses and the actors come across like the Three Stooges, all heading for the door at the same time. Today, thanks to the sleuthing of Phyllis Vine at Mental Illness Watch, we saw the stooges exposed in their clumsiness. Phyllis Vine discovered <a href="http://www.miwatch.org/2011/04/apas_ghostwriting_controversy_grows.html">material</a> on the corporate website of STI that has them featuring the textbook in the ‘portfolio’ that aims to attract new business to the company. Juxtapose that with the adjacent claim that STI’s skills are to "develop, write, edit, and submit a high-quality article to your target audience." Now is there any doubt about how this game is played? Now is there any doubt about whether the APA has come clean? <br /><br />Well, if there were any remaining doubt it has been removed by another development: All the materials describing the STI ‘portfolio’ have been removed from the company’s website. Fortunately, Phyllis Vine had captured it <a href="http://www.miwatch.org/2011/04/apas_ghostwriting_controversy_grows.html">here</a>, and so did <a href="http://carlatpsychiatry.blogspot.com/2011/04/new-smoking-gun-in-apa-textbook-fiasco.html">Daniel Carlat </a>through the <a href="http://replay.waybackmachine.org/20081121071704/http:/www.stimedinfo.com/results02_publications.htm">Wayback machine</a>. It was picked up some more by Mickey Nardo <a href="http://1boringoldman.com/index.php/2011/04/11/csi-miwatch/">today</a>. It looks like the APA is going to have more explaining to do. <br /><br />As the old Groucho Marx line goes, Who you gonna believe, them or your lying eyes? <br /><br />Bernard Carroll

...THEM OR YOUR LYING EYES?

…THEM OR YOUR LYING EYES? A few days ago I discussed stonewalling by the American Psychiatric Association over charges that they were partners in a ghostwritten textbook. The issue resonated with many…

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WHO YOU GONNA BELIEVE?

WHO YOU GONNA BELIEVE? <br /><br />Ghostwriting Charges and Stonewalling at the American Psychiatric Association <br /><br />The American Psychiatric Association came under a searchlight this past December over allegations of ghostwriting. The story originated with a public <a href="http://www.pogo.org/pogo-files/letters/public-health/ph-iis-20101129.html">letter</a> from Project on Government Oversight (POGO) to the Director of NIH, and it was picked up by Duff Wilson writing in the <a href="http://www.nytimes.com/2010/11/30/business/30drug.html?_r=3">New York Times</a>. The book was <i>Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care</i>. The named authors were Charles Nemeroff, now chairman of psychiatry at the University of Miami, and Alan Schatzberg, formerly chairman of psychiatry at Stanford University. Both are well known for ethical controversy – see <a href="http://hcrenewal.blogspot.com/search?q=Nemeroff">here</a> and <a href="http://hcrenewal.blogspot.com/search?q=Schatzberg">here</a>. Soon, these allegations were being dissected in the blogosphere, with stellar contributions from <a href="http://carlatpsychiatry.blogspot.com/2010/11/its-textbook-its-ad-its.html">Daniel Carlat</a>, <a href="http://1boringoldman.com/index.php/2011/01/21/when-charlie-met-sally/">1boringoldman</a>, <a href="http://www.pharmalot.com/2010/11/ghostwriting-from-medical-journals-to-entire-books/">Ed Silverman</a>, and <a href="http://alison-bass.blogspot.com/2010/12/government-oversight-agency-calls-on.html">Alison Bass</a>. <br /><br />The APA and its publishing arm, known as American Psychiatric Press, Inc. or APPI, came to the defense of the two prominent academic authors over the ghostwriting charge. In particular, an APA employee named Mark Moran authored a <a href="http://pn.psychiatryonline.org/content/46/2/1.1.full">denial </a>of the charge in the January 2011 issue of the APA news magazine, <i>Psychiatric News</i>. As the controversy played out, letters from attorneys demanded retractions, and partial qualifications of the original story appeared in the New York Times and on the POGO weblog. There was never any doubt that the heavy lifting was done by a pair of professional writers employed by a medical communications company under a financial grant from a drug company. Nemeroff defended his role by averring that he ‘scrutinized’ the work product of the professional writers. Threatening letters from lawyers for Nemeroff and Schatzberg were publicized, and the APA weighed in.<br /><br />The <i>coup de grâce</i> was administered by blogger Daniel Carlat’s withering <a href="http://carlatpsychiatry.blogspot.com/2010/12/nemeroff-and-schatzbergs-textbook.html">review</a> of the book’s artful construction to highlight the use of the sponsoring company’s antidepressant and anti-anxiety drug in primary care, while muting important information about the drug’s liabilities. Nevertheless, the APA held to its legalistic stance in defense of the ‘authors.’ This behavior is counterproductive for professional medical organizations, as I have discussed <a href="http://hcrenewal.blogspot.com/2010/12/impeachment-its-about-institution-not.html">before</a>, because it misses the ethical forest for the legal trees. <br /><br />Now comes the good part. In response to the piece by Mark Moran in <i>Psychiatric News</i>, Leemon McHenry prevailed on Robert Rubin and myself to write with him to the magazine’s editors. Leemon is a faculty member in the Department of Philosophy at California State University, Northridge. He also has experience evaluating legal documents arising in litigation over antidepressant drugs. Robert Rubin has partnered with me in outing several notable ethics compromises involving Nemeroff and Schatzberg, going back as far as 2002, though we always call ourselves equal opportunity critics. <br /><br />Our letter sent in late January to Dr. Carolyn Robinowitz, the Interim Editor of Psychiatric News, has been <a href="http://pogoblog.typepad.com/pogo/letter-to-apa-20110128.html">posted</a> today on the POGO site. In our letter, we challenged much of Mr. Moran’s defense, and we called attention to what WASN’T in the public domain, despite all the claims and counterclaims. Essentially, the partial qualifications of the original reports that appeared in The New York Times and in the letter to NIH from POGO resulted from the inconclusiveness of some of the documents. We called on the APA to come clean with the release of all relevant materials, in the interest of transparency. <br /><br />For instance, what WASN’T known were the specifics of the contract involving the corporation, the (ahem) authors, the publisher (APPI), and the medical communications company. Or the money flow to the ‘authors’ from the contract in addition to their royalties. Or the legal release form transferring ownership of the work product to the ‘authors’ and APPI. Or the corporation’s planned marketing activities, given that the corporation ordered 10,000 copies of the book. Or the correspondence among all parties that might reveal who actually did what. <br /><br />Leemon McHenry’s perspective is that this hidden layer of documents may well be available if they could be unsealed in pending litigation. Naturally, corporations and their attorneys strive to keep the information hidden. But our general point is that the APA has a different duty – which is to transparency rather than to stonewalling. Did the APA do that? Sadly, no, they did not. Here is the curt <a href="http://pogoblog.typepad.com/pogo/apa-response-20110322.html">reply</a> from the Executive Editor Catherine Brown denying publication of our letter after a delay of almost 8 weeks. Now that’s what I call stonewalling.

WHO YOU GONNA BELIEVE?

WHO YOU GONNA BELIEVE? Ghostwriting Charges and Stonewalling at the American Psychiatric Association The American Psychiatric Association came under a searchlight this past December over allegations o…

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IMPEACHMENT: IT’S ABOUT THE INSTITUTION, NOT THE PERSON

IMPEACHMENT: IT’S ABOUT THE INSTITUTION, NOT THE PERSON<br /><br />The impeachment trial of Judge G. Thomas Porteous of Louisiana this week was a lesson in civic ethics. The lessons of the Porteous trial apply to academic medical centers, professional medical societies, medical journals, and granting agencies like NIH. <br /><br />The Porteous trial is a straightforward case of bribes, kickbacks and corruption involving a Federal judge. The most enlightening arguments came from prosecutor Rep. Adam Schiff, D-California, laying out the case for impeachment in the Senate. He gave a lucid presentation of the logic and the historical origins of the impeachment process. The key points are these: impeachment serves to protect the dignity, honor, and credibility of the office more than to punish the wayward office holder; and impeachment is a constitutionally sanctioned way to clean the Augean stables without necessarily having to prove criminal liability. It is sufficient to demonstrate that the bad actors have brought disgrace on their offices.<br /><br />What this means for us in medicine is that legalistic charges and defenses are not the right way to go in exposing and ejecting bad actors from our field. In the highly publicized cases of ethical compromise over the past few years, our group disapproval, when there was any at all, generally has run on two parallel tracks. The first is legalistic, and it favors the bad actors, who flaunt their constitutional protections with the taunt, prove it. The second ground of disapproval is esthetic, based on the tackiness of the bad actors’ behaviors – regardless of technical legalities, what they do is an affront and an insult to professional standards and mores. When we look at how recent incidents in medicine actually played out, however, we see a disconnect. The bad actors have narrowed the debate to the first ground of disapproval, while forcing the second off limits. In this strategy, they have received conscious or unconscious assistance from the professional establishment. The focus has been on legal technicalities involving the bad actors rather on preserving the dignity and credibility of high offices in academic medicine.<br /><br />For instance, when Charles Nemeroff was exposed by Senator Grassley for conflict of interest in his NIH grants, he came up with the contrived legalistic defense that his unreported payments from GlaxoSmithKline were for ‘CME-like’ presentations, and thus somehow exempt from disclosure. Nemeroff’s obfuscations finally collapsed of their own weight and Emory University took decisive action against him, even though they had sufficient evidence dating back at least 4-5 years. In the end, Emory had to go through the wringer to discipline Nemeroff, and the institution suffered grave damage to its reputation for a number of years as the price of delay.<br /><br />For instance, when Thomas Insel, the Director of NIMH, assured Pascal Goldschmidt, Dean of the School of Medicine at the University of Miami, that Nemeroff was absolutely in good standing for applying for new NIH grants if he left Emory for Miami, despite a 2-year ban at Emory, he hewed to the letter of the law while disregarding its spirit in order to help his friend. Moreover, when Insel appointed Nemeroff to two new NIH Research Review Committees, he established beyond any doubt that he was intent on trying to help Nemeroff get back into circulation, and that he failed to grasp the gravity of the dishonor that Nemeroff inflicted on the field. This obtuseness on Insel’s part damaged the credibility and reputation of NIMH. To his credit, NIH director Francis Collins finally ‘got it’ and forced a review of the NIH ethics rules that had been entrusted to Insel.<br /><br />For instance, when Pascal Goldschmidt, Dean of the School of Medicine at the University of Miami, claimed he had done due diligence in his recruitment of Nemeroff as chair of his psychiatry department in 2009, he focused on the legalistic aspects of Emory’s review of Nemeroff, while failing to understand the degree of negative publicity associated with Nemeroff’s name. He ended up hiring someone who is an object of ridicule, and he in turn is ridiculed by association.<br /><br />For instance, when Stanford University learned of Alan Schatzberg’s boundary violations vis a vis his NIH-funded projects and his personal corporation, they first pushed back on legalistic technical grounds. Only later did the Stanford administration get the message by removing Schatzberg from his Principal Investigator role with NIH grants, and eventually appointing a new chair of psychiatry. Meanwhile, the public image of Stanford suffered.<br /><br />For instance, when the American Psychiatric Association was warned that Alan Schatzberg was a problematic candidate for election as President of the association on account of his history of ethical compromise, they went ahead anyway and they have since had opportunity to regret that decision. Here again, the professional society appears to have lost sight of the ethical forest for the legal trees. The credibility and reputation of the APA have suffered because of the taint associated with Schatzberg’s presidency.<br /><br />For instance, when the New York Times recently exposed the ghostwriting associated with the 1999 textbook of Charles Nemeroff and Alan Schatzberg, the so-called authors responded with typical legalistic defenses. They and the University of Miami and the American Psychiatric Association Press (the publisher) again lost sight of the ethical forest for the legal trees. This stereotyped, public relations driven response ignores the visceral and esthetic distaste most observers felt on learning about the collusion between the ‘authors,’ the professional writing company and the sponsoring pharmaceutical corporation. Even the defense that it occurred a long time ago fails. In the Porteous trial, the prosecution established that dishonorable events in an officer’s past are grounds for impeachment, whether or not they also occurred during the person’s time in office. <br /><br />For instance, when Harvard Medical School planned a <a href="http://cme.hms.harvard.edu/cmeups/pdf/03124280.pdf">new CME program </a>on psychopharmacology in mid-2011, they engaged a number of compromised academic speakers, including Nemeroff and Schatzberg. What the hell was Harvard thinking? I told the Course Director, Carl Salzman, that this amounts to pandering. He replied defensively that Nemeroff and Schatzberg are well regarded speakers and that he would ensure that they gave unbiased presentations. That’s not the point. The point is that they have done serious damage to our field, and for Harvard Medical School to give them top billing amounts to denial of the elephant in the living room. It’s collusion in service of their public rehabilitation. I told Dr. Salzman that his logic amounts to compartmentalized thinking. I might have added that Adolf Hitler gave a lot of great speeches that received rave reviews and that compartmentalized thinking was widespread in the nation of Germany between 1928 and 1945. Meanwhile, Harvard Medical School gets a black eye through its association with these compromised individuals. So do the other speakers who will be on the panel. Who needs this kind of taint? Dr. Salzman can defend Nemeroff and Schatzberg all he wants on specious legalistic grounds, but who cares? Harvard Medical School could use some moral clarity.<br /><br />So, we come back to the impeachment trial of Judge Porteous. Impeachment protects the institution. When sleazebags get into positions of authority and trust they need to be dumped, and our professional and academic institutions need to have enough spine to dump them. At the very least, we don’t need to tolerate institutions like Harvard Medical School pandering to compromised academic bad actors. For shame.

IMPEACHMENT: IT’S ABOUT THE INSTITUTION, NOT THE PERSON

IMPEACHMENT: IT’S ABOUT THE INSTITUTION, NOT THE PERSONThe impeachment trial of Judge G. Thomas Porteous of Louisiana this week was a lesson in civic ethics. The lessons of the Porteous trial apply to…

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THAT'S EDUCATION!

THAT’S EDUCATION!<br /><br />You can’t make this stuff up.<br /><br />This week I received a cheerful E-mail from a well known academic key opinion leader or KOL. Only the E-mail didn’t really come from Dr. Ian Cook at UCLA. It really came from a company called PeerView Institute for Medical Education. The E-mail offered on-line CME content with the topic <em>Essential Aspects to Building a Therapeutic Alliance Between Patients and Practitioners for the Treatment of Mood Disorders.</em> Whenever I see an anodyne title like that I know there’s trouble ahead.<br /><br />The content came in the form of a dialogue between Dr. Cook and another well known academic KOL, Dr. Michael Thase from Penn. Beneath two prominent corporate logos, a disclosure stated <em>This activity is supported by educational grants from AstraZeneca LP and Lilly USA, LLC. </em>Another disclosure stated<em> This CME/CNE/CPE activity is jointly sponsored by Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education.</em> The program also states <em>This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education. Purdue University College of Pharmacy, an equal access/equal opportunity institution, is accredited by the ACCME to provide continuing medical education for physicians.<br /></em>I happen to know Dr. Cook and Dr. Thase, so already I am thinking why are these productive academic researchers from first tier universities doing a yawner CME gig like this? Then I get it. Most academic physicians have been told by now that they may no longer speak for hire at dinners and events sponsored by Pharma. You know, the sort of thing that Charles Nemeroff tried to pass off as CME-like, only Senator Grassley <a href="http://www.pharmalot.com/2008/12/glaxo-nemeroff-and-cme-like-promotions/">wasn’t buying it</a>. So now the action has moved to commercial CME activities that carry the imprimatur of ACCME, thus confirming the principle that the flow of marketing money must find an outlet.<br /><br />My jaundiced view of ACCME’s performance and credibility is a <a href="http://hcrenewal.blogspot.com/2009/10/nemeroff-seroquel-and-accme.html">matter of record</a>. For that matter, I am on record with a jaundiced view of the entire CME business. Here is what I <a href="http://hcrenewal.blogspot.com/2008/01/variations-on-theme-of-sleaze.html">said</a> back in 2008.<br /><br /><em>…Continuing Medical Education (CME) is a second front in the campaign to expand (drug markets). The standard formula calls for corporate sponsorship channeled through an “unrestricted educational grant” to a medical education communications company (MECC). The MECC employs writers to prepare the “educational content,” and academic KOLs are recruited to deliver this content. The KOLs are chosen for their willingness to be “on message” for the corporate sponsor. If they go “off message” they know they will not be invited back. The talk of “unrestricted grants” is window dressing. The MECC also secures the imprimatur of a nationally accredited CME sponsor, typically an academic institution. The sponsor is paid to certify that the CME program meets the standards of the Accreditation Council on Continuing Medical Education (ACCME). Everybody turns a buck: the MECC and its staff are handsomely paid (CME is now a multi-billion dollar business); the KOLs are generously rewarded with honoraria and perquisites; the academic sponsor is well paid by the MECC; the ACCME receives dues from the academic sponsor; the audience obtains free CME credits rather than having to pay for these required educational experiences; and the corporate sponsor gets what it considers value for its marketing dollar.<br /></em>So, I approached this free on-line CME offering with a good deal of skepticism. Most of the content was pedestrian and scripted – not because these KOLs couldn’t have done better but because someone at the MECC scripted it for them. Someone at the MECC also put the slides together, about which more in a moment. The material was formulaic, a succession of clinical banalities accompanied by Power Point slides that said everything and nothing. I cannot imagine that a physician would learn anything substantive from these educational tropes.<br /><br />The impresarios at PeerView Institute for Medical Education, funded by Lilly and AstraZeneca, came through with the desired spin. The corporate sponsors obtained the soft messaging they wanted. Their products olanzapine and quetiapine were not promoted overtly, but it was surely gratifying that the content emphasized the accepted place of such second generation antipsychotic drugs as a class in mood stabilization for bipolar disorder and in augmentation for nonresponsive major depression. This soft messaging was delivered with the appearance of authority, within a package of algorithms, strategies, Venn diagrams, and measurement tools that featured potential upsides but gave hardly a nod to the worrisome side effects of such drugs, especially <a href="http://ajp.psychiatryonline.org/cgi/content/full/167/2/216">in depressed patients </a>. And it surely was no accident that the sponsors’ drugs appeared as exemplars in slides and in the follow-up questions – another form of soft messaging.<br /><br /><br />Finally, I came upon incontrovertible evidence that these KOLs did not prepare the educational content of the program. A slide that discussed antidepressant drug options contained a panel dealing with the MAO Inhibitors (MAOIs). This class of antidepressant drug appeared in the 1950s, and MAOIs still have a limited place in clinical practice. The information given about the MAOI drugs in the enduring material (slide) of this program, however, is dated, inaccurate, and dangerous. Here is the relevant section of the slide.<br /><br />CLASS<br />MAOIs (eg, benmoxin, hydralazine phenelzine, pheniprazine)<br /><br />EFFICACY<br />↓ efficacy compared to TCAs 4<br /><br />COMMON SIDE EFFECTS<br />• Drowsiness, dizziness, loss of visual acuity, GI side effects, insomnia, irritability 4<br /><br />What’s wrong with this? Plenty. Benmoxin has never been marketed in the US and was discontinued in Europe many years ago. Hydralazine is not an MAOI but an antihypertensive agent. Pheniprazine was discontinued many years ago due to marked toxicity. Meanwhile there is no mention of tranylcypromine or selegiline or moclobemide, which are in current use. The listing of hydralazine, which has no antidepressant activity, is especially dangerous. Likewise, the laundry list of side effects manages to omit the single most important problem with the MAOI class – potentially lethal dietary and drug interactions.<br /><br />There is only one way to say it – this educational content is incompetent, reckless, and dangerous. I know both the KOLs well enough to be certain they would never develop such educational content themselves. So, who did develop it? Some functionary at PeerView Institute for Medical Education, who had no clue what s/he was doing. Compounding the problem, the Purdue University College of Pharmacy waved through this incompetent material for CME credit. If the Purdue University College of Pharmacy wants to provide continuing education for pharmacists, fine. But I draw the line at allowing an institution that does not train physicians to provide continuing education for physicians. I do not understand why this is permitted by ACCME. On the evidence of this program, the Purdue University College of Pharmacy lacks the expertise to provide continuing education for physicians.<br /><br />The standard is simple. The standard is not ‘we try to ensure accuracy’… the standard is we get it right – that’s what our role models teach us in medical school and residency training. These KOLs are accountable for the reckless errors in this content because they allowed their names to be featured as the authorities. Plainly, they did not develop the educational content and they did not take the time to review the enduring materials as their accountability required.<br /><br />Why have the deans of US medical schools not banned academic physicians from participating in such commercial CME gigs? It is no secret how phony <a href="http://hcrenewal.blogspot.com/2009/10/nemeroff-seroquel-and-accme.html">these events </a>are. Why not help these busy academic clinical scientists to maintain their focus by limiting them to educational programs at academic medical centers and at meetings and functions genuinely sponsored by professional medical societies? As the present example shows, anything else is business as usual under cover of a fig leaf.<br /><br />I want to be clear that I have enjoyed friendly relationships with Ian Cook and Michael Thase for a long time. It’s not personal, it’s about standards and it’s about tradecraft. If academic KOLs are too busy to maintain standards and tradecraft then they should pass up these educational charades. For shame, guys.<br /><br />Bernard Carroll

THAT'S EDUCATION!

THAT’S EDUCATION!You can’t make this stuff up.This week I received a cheerful E-mail from a well known academic key opinion leader or KOL. Only the E-mail didn’t really come from Dr. Ian Cook at UCLA.…

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ETHICS TURNAROUND (sort of) by NIH INSTITUTE DIRECTOR

ETHICS TURNAROUND (sort of) by NIH INSTITUTE DIRECTOR<br /><br />What a difference a month makes. When I went on vacation in June the Director of NIMH, Thomas Insel, was stonewalling about his relationship with Charles Nemeroff. Insel wanted to put distance between himself and the poster boy for conflict of interest in academic medicine. The heat was on Insel because of revelations that he helped Nemeroff get a new position at Miami after his fall from grace at Emory. Insel also gave a green light for Nemeroff to reapply for NIMH grant funding, and he appointed Nemeroff to new research review committees. These actions were widely seen as efforts to help Nemeroff get back into circulation. It didn’t help that people called attention to past favors and lobbying by Nemeroff on behalf of Insel.<br /><br />Things continued to unravel, and on about June 29 Insel placed a <a href="http://www.nimh.nih.gov/about/director/2010/more-on-public-trust-and-conflict-of-interest.shtml">disclaimer</a> on his official blog. Insel here allowed that his earlier official statements <i>“may be viewed as misleading.”</i> This softening of Insel’s position was picked up June 29 by the <a href="http://chronicle.com/blogPost/NIH-Official-Softens-Denial-of/25174">Chronicle of Higher Education</a>. Not only was Insel’s disclaimer on his official weblog undated, it is mealy mouthed and it was widely criticized – <a href="http://hcrenewal.blogspot.com/2010/06/insel-admits-his-statements-may-be.html">here</a> and <a href="http://1boringoldman.com/index.php/2010/06/29/plausible-deniability-is-neither-a-medical-nor-scientific-standard/">here</a>, for instance – as further evidence of Insel’s disingenuousness.<br /><br />By July 7 we learned of further revisions to Insel’s position. In response to pressure from Senator Charles Grassley (R-Iowa), Insel <a href="http://freepdfhosting.com/2e0f575924.pdf">issued</a> a <i>mea culpa</i> in which he agreed that Nemeroff’s actions constituted <i>“an egregious violation of NIH policy and University rules.”</i> Insel also acknowledged that his willingness to help Nemeroff <i>“may have created the appearance of favoritism. In retrospect, I regret that my actions… appear inappropriate for a Federal research official given my past association with Dr. Nemeroff.”</i> This new statement also was raked over as further evidence of Insel’s dissembling – see <a href="http://www.pharmalot.com/2010/07/nimhs-insel-on-nemeroff-i-regret-my-actions/">here</a> and <a href="http://1boringoldman.com/index.php/2010/07/08/a-start/">here</a> and <a href="http://www.margaretsoltan.com/?p=24272">here</a>.<br /><br />Nowhere in Insel’s new self serving statements is there any apology for his ill advised appointment of Nemeroff to new Federal research review panels. This signals once again that Insel just doesn’t get it when it comes to his crony Nemeroff. It is not in the job description of an NIH Institute Director to taint research review panels with compromised and sanctioned scientists.<br /><br />Keep in mind that the appearance of malfeasance and impropriety most often occurs in the presence of malfeasance and impropriety. That is a standard Bayesian proposition that Insel seems not to grasp.<br /><br />In light of these developments, who can take seriously the work Dr. Insel says he has done to develop a new NIH initiative on ethics? The leadership of NIH tacitly acknowledged this problem when they recently <a href="http://blogs.nature.com/news/thegreatbeyond/2010/07/nih_extends_public_comment_per.html">extended</a> the period of comment on the new ethics proposals. This was done specifically to mend the regulatory hole that Insel and his crony Nemeroff walked through when Insel assured Pascal Goldschmidt at Miami that Nemeroff could go right ahead to apply for new NIMH funding. Left to his own initiative, Insel kept the hole wide open. His July 7 statement to Senator Grassley that "<i>I do not condone the gap in our policy that allowed (Nemeroff) to avoid the penalty implemented by Emory by moving to another university…”</i> rings hollow: actions speak louder than words, and Insel had many months in which he could have closed the gap before the present scandal surfaced.<br /><br />How much longer can NIH tolerate an ethical prevaricator as an Institute Director?<br /><br />Bernard Carroll

ETHICS TURNAROUND (sort of) by NIH INSTITUTE DIRECTOR

ETHICS TURNAROUND (sort of) by NIH INSTITUTE DIRECTORWhat a difference a month makes. When I went on vacation in June the Director of NIMH, Thomas Insel, was stonewalling about his relationship with C…

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INSEL and NEMEROFF - WHAT SANCTIONS?

INSEL and NEMEROFF – WHAT SANCTIONS?<br /><br />Thomas Insel, Director of NIMH, has another <a href="http://www.nimh.nih.gov/about/director/2010/more-on-public-trust-and-conflict-of-interest.shtml">posting</a> in his own defense on his official blog today. He has been widely <a href="http://http//hcrenewal.blogspot.com/2010/06/public-trust-at-nimh.html">criticized</a> lately for the appearance of cronyism in his relationship with Charles Nemeroff. For the past three months, Insel has been trying to put some distance between himself and Nemeroff, but the public isn’t buying it. I have called his statements disingenuous <a href="http://hcrenewal.blogspot.com/2010/04/quis-custodiet-ipsos-custodes.html">here</a> and <a href="http://www.miamiherald.com/2010/06/10/1672327/senator-tells-um-hes-troubled.html">here</a>. Dr. Insel’s statements today are equally disingenuous. <a href="http://1boringoldman.com/index.php/2010/06/15/de-barred-not-a-bad-idea/">Negative reactions</a> are already appearing from those familiar with Nemeroff’s history.<br /><br />There is no argument that Nemeroff was instrumental in Insel’s move to Emory in 1994, that Nemeroff was Insel’s department chairman at Emory, that Nemeroff helped Insel again when Insel’s initial term as director of the Yerkes laboratory at Emory was not renewed in 1999, or that Nemeroff lobbied for Insel’s appointment as NIMH Director in 2002. There is no argument that Insel and Nemeroff have given <a href="http://hcrenewal.blogspot.com/2010/04/quis-custodiet-ipsos-custodes.html">glowing public recommendations </a>of each other, or that they have a record of <a href="http://www.pharmalot.com/2010/06/can-the-nih-really-monitor-conflicts-of-interest/">cozy personal communications</a>. There is no doubt that Pascal Goldschmidt at Miami sought and received a recommendation from Insel before hiring Nemeroff last year or that Insel went out of his way to put a personal gloss on the official NIH position regarding Nemeroff’s eligibility for grant funding if he left Emory. These are matters about which Dr. Insel prevaricates today in his blog.<br /><br />Continuing his prevarication, Dr. Insel today also avoids confronting the issue of Nemeroff’s continuing service on NIMH review committees under Insel’s watch during the period that he was under sanction by Emory University, and banned from participating in NIH grants – before he relocated to Miami. Nemeroff’s <i>curriculum vitae</i> on the U Miami website states that he is a member of the NIMH Review Group, <i>Interventions Committee for Adult Mood and Anxiety Disorders (ITAV), 7/1/2006 - 6/30/2010</i>. This means Insel allowed Nemeroff to continue in that peer review role even though he was banned by Emory from association with NIH grants. The question is why? And what does that tell us about Insel's judgement?<br /><br />It gets worse. During the period that Nemeroff was at Emory and under sanction vis à vis NIH grants, he continued to function as operational director of a NIMH-funded program administered by the American Psychiatric Association (APA). It is inconceivable that Insel was not aware of this arrangement. The APA program is known as Research Colloquium for Junior Investigators, and it is funded through NIMH project # 5R13MH064074-10. For the past few years Nemeroff, as Chair of the APA Committee on Research Training, has directed this program. The nominal Principal Investigator is Darrel Regier, who is the Executive Director of the American Psychiatric Institute for Research and Education (APIRE). At the session in New Orleans during the annual APA meeting last month, one of the featured speakers was Bruce Cuthbert, PhD, one of Insel’s principal lieutenants. In God’s name, why is the APA fronting the compromised Nemeroff as a role model to junior investigators, and why does NIMH/Insel allow this unsavory arrangement to continue? Could it be that Nemeroff’s crony <a href="http://hcrenewal.blogspot.com/2008/08/follow-money-part-ii.html">Alan Schatzberg</a>, the outgoing president of the APA, ran interference for his friend? And what will the new APA president Carol A. Bernstein do about it?<br /><br />And then there is the issue of Nemeroff’s appointment to two new NIMH review committees just recently. Dr. Insel prevaricates again about his awareness or approval of those actions. As reported by Paul Basken in the <a href="http://chronicle.com/article/While-Revising-Ethics-Rules/65800">Chronicle of Higher Education</a>, <i>“An NIH spokesman, John T. Burklow, answering written questions about the matter, confirmed Dr. Nemeroff's full eligibility for agency activities and said he will begin serving this coming week on two scientific panels that review NIH grant applications.”</i> Here again, Dr. Insel seems to be trying to help his crony Nemeroff to get back into circulation after his fall from grace at Emory.<br /><br />Emory University went through the wringer to discipline Nemeroff, at long last, in 2008. The actions of Insel in running interference for Nemeroff’s rehabilitation must leave Emory perplexed. Are Dr. Insel’s statements today disingenuous? You bet. Isn’t it time for the adults at NIH to step in and end this farce?

INSEL and NEMEROFF - WHAT SANCTIONS?

INSEL and NEMEROFF – WHAT SANCTIONS?Thomas Insel, Director of NIMH, has another posting in his own defense on his official blog today. He has been widely criticized lately for the appearance of cronyi…

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Public Trust at NIMH?

Public Trust at NIMH?<br /><br />The NIMH Director, Thomas Insel, MD, is under siege for his problematic relationship with Charles Nemeroff. In his own defense, Insel placed a remarkable new <a href="http://www.nimh.nih.gov/about/director/2010/nimh-reducing-conflict-of-interest-ensuring-public-trust.shtml">post</a> today on his official blog. It signals that Insel and NIMH just don’t understand the current controversy. Since the story appeared in <a href="http://chronicle.com/article/While-Revising-Ethics-Rules/65800">The Chronicle of Higher Education</a> 2 days ago, it has reverberated on <a href="http://hcrenewal.blogspot.com/2010/06/happy-times-at-nimh-part-iii.html">Health Care Renewal</a>, on <a href="http://www.pharmalot.com/2010/06/can-the-nih-really-monitor-conflicts-of-interest/">Pharmalot</a>, on <a href="http://www.margaretsoltan.com/?p=23664">University Diaries</a>, on the <a href="http://blogs.nature.com/news/thegreatbeyond/2010/06/another_conflict_brouhaha_for_1.html">Nature blog</a>, on the <a href="http://news.sciencemag.org/scienceinsider/2010/06/nih-conflicts-overhaul-bumps-up-.html">Science blog</a>, and on <a href="http://scienceblogs.com/drugmonkey/2010/06/more_evidence_that_the_nih_has.php?utm_source=networkbanner&utm_medium=link">Drug Monkey</a>, to name just a few. The authors on these sites have been uniformly critical of Insel and of NIMH, as have almost all the comments.<br /><br />What does Dr. Insel say in his defense today? Mainly, he demonstrates that he doesn’t get it. The very way in which he frames the issue tells us that. First he says it is about financial conflicts of interest. It isn’t. It is about the corruption of academic psychiatry. Financial conflicts of interest are just a part of that problem. Second, he says it is about whether the bad boys and girls in psychiatry were badder than those in other medical specialties. It isn’t. It never was. Third, he says he is surprised by criticism that he and NIMH have not taken firm action against the bad boys and girls, then he spends the rest of his column evading that issue. This degree of sophisticated indirection is achieved only in the highest echelons of bureaucracies.<br /><br />Instead of a frank discussion of the real issues, we get a self serving description of the ways in which NIMH has taken steps to preserve the integrity of the research that it funds (starting after the scandal about the bad boys and girls broke within the Senate Finance Committee in 2008 – a detail not included by Dr. Insel. Where were they before?). By the time one makes it through this glossed-up history and the new promissory notes, it is easy to lose sight of what provoked the controversy this week.<br /><br />It’s about the appearance of hypocrisy, with Insel assisting the compromised Nemeroff to land a new job at Miami while he is co-chairing a NIH effort to revise ethics guidelines.<br /><br />It’s about consistency of discipline. After Emory University went through the wringer to discipline Nemeroff, at long last, and to ban him from involvement with NIH grants for 2 years, doesn’t NIH have a responsibility to make the discipline stick? After all, NIH deferred to Emory in the investigation of Nemeroff to begin with. What message does it send for Insel, a well known crony of Nemeroff, to blithely assure Pascal Goldschmidt at Miami that Nemeroff is “absolutely in fine standing” with NIH and that he “not only could begin applying for NIH grants as soon as he arrived in Coral Gables, but that he could also continue to serve on the NIH's expert panels that help decide on which grant applications win federal financing?” As Drug Monkey said, “It’s about optics, NIH. This doesn’t look good.” It looks instead like cronies exploiting the gaps and inconsistencies in administrative oversight between academic centers and NIH. <br /><br />It’s also about common sense and administrative propriety. Let us perhaps grant that Insel could not prevent or discriminate against Nemeroff in applying for new NIMH funding. There is weasel wording to cover Insel if he chose to take such a position. But does that mean Insel has no discretion over whether Nemeroff is invited onto <i>two new NIMH review panels</i>? Nemeroff has no entitlement to claim a place on these peer review panels. Whatever possessed Insel to extend this privilege to a compromised individual like Nemeroff? The answer plainly is that Insel doesn’t recognize the compromise and corruption of his crony Nemeroff. The appearance is that Insel is setting out to help Nemeroff get back into circulation after his fall from grace at Emory.<br /><br />By his own blog posting today Insel tells us that he lacks the grasp of nuanced issues that his position requires. He doesn’t get the big picture in this controversy or, if he does, he wants to evade it. Either way, NIMH deserves better.<br /><br />Bernard Carroll.

Public Trust at NIMH?

Public Trust at NIMH?The NIMH Director, Thomas Insel, MD, is under siege for his problematic relationship with Charles Nemeroff. In his own defense, Insel placed a remarkable new post today on his off…

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HAPPY TIMES AT NIMH – PART III

<b>Happy Times at NIMH – PART III</b><br /><br />The unraveling of Thomas Insel, MD, Director of the National Institute of Mental Health continues. His ties with the poster boy for conflict of interest in psychiatry, Charles Nemeroff, MD, are getting new exposure. The story is notable not only for what it says about Insel and Nemeroff, but also for what it says about the ethical culture within NIMH.<br /><br />The latest <a href="http://chronicle.com/article/While-Revising-Ethics-Rules/65800/">exposé</a> is from Paul Basken in yesterday’s Chronicle of Higher Education. Mr. Basken laid out the appearance of hypocrisy within NIH, with Insel leading an NIH initiative for strengthening ethics rules for medical researchers while he was “quietly help(ing) one of the most prominent transgressors get hired by the University of Miami after a decade of undisclosed corporate payments…” That, of course, would be Nemeroff.<br /><br />Nemeroff’s new boss at the University of Miami was reassured by Insel last July “that Charlie was absolutely in fine standing" with the NIH. Pascal Goldschmidt, MD, the dean at U Miami, told Mr. Basken “…he was pleased to hear from Dr. Insel that Dr. Nemeroff not only could begin applying for NIH grants as soon as he arrived in Coral Gables, but that he could also continue to serve on the NIH's expert panels that help decide on which grant applications win federal financing.”<br /><br />Let’s think about what is going on here. If Insel wanted to do favors for Nemeroff, because he owes Nemeroff big time, his rationalization was that Nemeroff has not (yet) been adjudicated a felon. Nemeroff’s case was referred to the Inspector General of HHS by Senator Charles Grassley (R-Iowa) and we don’t know what the outcome will be. So Insel encourages Nemeroff to apply for NIH grants and he allows Nemeroff to begin new service on NIH review committees. As one of Insel’s lieutenants put it, “The NIH must "treat everyone equally unless they have been 'debarred' from funding… " Thus do federal bureaucrats cover their asses by invoking procedural technicalities in order to help their cronies. For NIMH under Insel’s leadership to extend these privileges to a compromised individual like Nemeroff makes as much sense as would allowing the unindicted Michael Corleone to serve on the jury in the trial of Hyman Roth, upon the recommendation of Senator Pat Geary (consult the plot of The Godfather, Part II). Paul Basken’s exposé contains much additional information about cozy, private E-mail traffic between Insel and Nemeroff. As I have commented before, maybe it is time for Insel to recalibrate his ethical compass.<br /><br />All of this new information validates concerns that I raised over recent months <a href="http://hcrenewal.blogspot.com/2010/03/dr-pangloss-as-nih-institute-director.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/04/quis-custodiet-ipsos-custodes.html">here</a>. I said then that Dr. Insel appeared disingenuous in trying to put distance between himself and Dr. Nemeroff. These new revelations by Paul Basken confirm the cronyism in their relationship. In his recent published <a href="http://jama.ama-assn.org/cgi/content/extract/303/12/1192">commentary</a>, Insel downplayed the gravity of the ethical issues surrounding Dr. Nemeroff and some other academic psychiatrists. Basically, he allowed for them to cop a plea on the issue of disclosing payments from corporations, and he tried to point fingers at other medical specialties, while he glossed over the evidence of their wider corruption. With some sadness, one needs now to say that the Director of NIMH cannot or will not recognize the corruption of his cronies. Is that the style of ethical leadership we should expect from an NIH Institute Director?<br /><br />Bernard Carroll.

HAPPY TIMES AT NIMH – PART III

Happy Times at NIMH – PART IIIThe unraveling of Thomas Insel, MD, Director of the National Institute of Mental Health continues. His ties with the poster boy for conflict of interest in psychiatry, Ch…

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