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 intere...

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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 WALK For some time a jeremiad theme has been dominant in the psychiatric sector of the academic-industrial complex . Blockbuster ps...

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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 199...

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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 DIRECTOR What a difference a month makes. When I went on vacation in June the Director of NIMH,...

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Insel Admits His Statements "May be Viewed as Misleading"

Dr Bernard Carroll has posted several times, most recently <a href="http://hcrenewal.blogspot.com/2010/06/insel-and-nemeroff-what-sanctions.html">here</a>, about shenanigans by "key opinion leaders" in psychiatry whose apparently academic writing and speeches have conveyed messages in line with the marketing agendas of drug and device companies, while they downplayed or concealed their financial ties to these companies.  Lately, Dr Carroll <a href="http://hcrenewal.blogspot.com/2010/06/insel-and-nemeroff-what-sanctions.html">noted</a> how the current director of the US National Institute for Mental Health (NIMH), Dr Thomas Insel, has defended Dr Charles Nemeroff, whose recent move to the University of Miami let him shed sanctions imposed by Emory University for his failure to disclose conflicts of interest while he was there. Dr Carroll wrote, "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...."<br /><br />Dr Carroll is on vacation, so in his absence, I note the following from a <a href="http://chronicle.com/blogPost/NIH-Official-Softens-Denial-of/25174/">brief article</a> in the Chronicle of Higher Education:<br /><blockquote>The director of the National Institute of Mental Health, Thomas R. Insel, has <em>softened his denial of a mutually helpful relationship with Charles B. Nemeroff,</em> a university researcher found to have repeatedly collected undisclosed corporate payments. In an update to his official blog posting, Dr. Insel said his initial denial of job assistance from Dr. Nemeroff <em><strong>'may be viewed as misleading,'</strong></em> and <em>acknowledged that Dr. Nemeroff served in key positions related to Dr. Insel's hiring by Emory University.</em></blockquote><br />This seems to corroborate Dr Carroll's skepticism. I wonder what other statements by Dr Insel, or Dr Nemeroff for that matter, ought to be "viewed as misleading?"<br /><br />We have said repeatedly that commercially sponsored "key opinion leaders" are really part-time drug marketers disguising themselves as academics or distinguished practitioners. The deceptions inherent in these roles seem to lead to a certain habitually elastic approach to the truth.<br /><br />Medical academics and practitioners will need a renewed commitment to honesty and transparency if they want to regain the respect of an increasingly skeptical, if not cynical public.

Insel Admits His Statements "May be Viewed as Misleading"

Dr Bernard Carroll has posted several times, most recently here , about shenanigans by "key opinion leaders" in psychiatry whose a...

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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 ...

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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...

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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 III The unraveling of Thomas Insel, MD, Director of the National Institute of Mental Health continues. His ties w...

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Quis Custodiet Ipsos Custodes?

HAPPY TIMES AT NIMH<br /><br />Two weeks ago I <a href="http://hcrenewal.blogspot.com/2010/03/dr-pangloss-as-nih-institute-director.html">discussed</a> a Commentary in JAMA by Dr. Thomas Insel, Director of the National Institute of Mental Health. Over on <a href="http://carlatpsychiatry.blogspot.com/2010/03/dr-tom-insel-nimh-chief-scolds.html">Danny Carlat’s blog</a>, Dr. Insel took exception to my linking him with Charles Nemeroff, and appeared to be putting distance between himself and Dr. Nemeroff. So, I did some checking, and a correction to one of my statements is in order.<br /><br />I had said, <i>“ … that Insel appointed Nemeroff as an advisor soon after he (Insel) moved to NIMH.”</i> That was my recollection. It turns out what I recalled was instead Insel showcasing Nemeroff in the NIMH Director’s 7th Annual Research Roundtable June 10, 2003, a few months after Insel moved from Emory University to NIMH. Let the record stand corrected.<br /><br />At that gala meeting, held at the National Press Club in Washington, DC, Dr. Insel characterized Nemeroff as one of the “real stars of NIMH’s research community…” Nemeroff used the occasion to pimp GlaxoSmithKline’s drug paroxetine (Paxil), showing data on change in platelet stickiness after Paxil in patients with heart disease and depression. This highlighting of Paxil by Nemeroff focused on the surrogate outcome of platelet function, and contained no evidence that Paxil modified any important clinical endpoints. Nevertheless, Nemeroff speculated liberally about the place of antidepressant drugs in managing heart disease. This is the sort of stuff Insel described at the Roundtable as “ … an excellent sampling of the Institute’s exciting research endeavors.”<br /><br />My general point two weeks ago was that Dr. Insel, the Director of an NIH Institute, downplayed the seriousness of the ethics issues surrounding the seven academic psychiatrists he mentioned in his Commentary in JAMA. Though he spoke in platitudes about the need for transparency, the spirit of transparency did not move him to disclose his own close ties with Dr. Nemeroff, who is one of the seven. Lest there be any remaining doubt about those ties, here is Dr. Nemeroff lauding Dr. Insel at the 201st meeting of the National Advisory Mental Health Council September 13, 2002 in the presence of the NIH Director, Elias Zerhouni, MD. From the Minutes: <i> Dr. Charles Nemeroff, Reunette W. Harris Professor and Chair, Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, commended Dr. Zerhouni’s selection of Dr. Insel as the next NIMH Director and added that Dr. Insel is the epitome of courage defined as grace under pressure. Dr. Nemeroff added that Dr. Insel will leave his current position as a most beloved professor, a respected scientist, and a great person.</i><br /><br />In the comments on Danny Carlat’s blog I called Dr. Insel’s objections to my linking him with Nemeroff disingenuous. I still think that. Dr. Insel and Dr. Nemeroff are closer than Insel now seems comfortable acknowledging. Their record of talking up each other is hard to ignore. The irregularities identified by Senator Grassley involving Nemeroff’s reporting to NIH, his conflict of interest, and his conflict of commitment occurred on Insel’s watch. Considering the appearance of cronyism in their relationship, is it even possible for Dr. Insel to investigate Dr. Nemeroff’s performance in areas like the Emory-GlaxoSmithKline-NIMH Collaborative Mood Disorders Initiative?<br /><br />Bernard Carroll

Quis Custodiet Ipsos Custodes?

HAPPY TIMES AT NIMH Two weeks ago I discussed a Commentary in JAMA by Dr. Thomas Insel, Director of the National Institute of Mental Health...

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DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR<br /><br />JAMA is out today with a <a href="http://jama.ama-assn.org/cgi/content/extract/303/12/1192">Commentary</a> by Dr. Thomas Insel, Director of the National Institute of Mental Health. Using indirection, Dr. Insel has risen to the defense of seven academic psychiatrists on whom an ethical searchlight has been trained for the past several years by Senator Grassley and others. With ludicrous optimism and a series of straw man discussions, Dr. Insel makes the case that things are not really as bad as they seemed to be or, if they were, then other specialty physicians were doing much the same things. Dr. Insel needs to recalibrate his ethical compass.<br /><br />Why is an NIH Institute Director issuing this apologia for the corruption of academic psychiatry? Does he not have better things to do, such as ensuring that longstanding NIH regulations on conflict of interest are enforced? Why does an NIH Institute Director presume to speak for academic psychiatry? Where are the leaders of the major professional and scientific organizations like the American Psychiatric Association, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the Society of Biological Psychiatry? Why are they not stepping up publicly to the plate? Perhaps they are confounded by the awkward fact that some of the seven individuals are current and past presidents of these very organizations. Even the Institute of Medicine of the National Academy of Sciences has not sanctioned those of the seven who are Institute members.<br /><br />Why is an NIH Institute Director downplaying the gravity of the ethical controversies surrounding these compromised individuals like Charles Nemeroff at Emory (now at Miami), and Alan Schatzberg at Stanford? To hear Dr. Insel tell it, all they did was fail to disclose income from pharmaceutical companies. That is not the half of it. Readers can look <a href="http://hcrenewal.blogspot.com/search?q=Nemeroff">here</a> and <a href="http://hcrenewal.blogspot.com/search?q=Schatzberg">here</a> for much more detail on the activities of Nemeroff and Schatzberg. If Dr. Insel chose to remain ignorant of or to overlook the history of false claims on behalf of pharmaceutical corporations or the concealment of consulting relationships or the complaisance with ghostwriting or the patently misleading “educational” presentations or the cashing in through stock sales or the editorial self dealing, then Dr. Insel’s fitness to serve as an NIH Institute Director needs to be reviewed.<br /><br />Surely Dr. Insel knows that Nemeroff and the others worked mainly with the marketing personnel within pharmaceutical companies. Nemeroff’s staggering schedule of promotional talks for GlaxoSmithKline, released by Senator Grassley, is testament to that. So is Nemeroff’s record of priming the pump for himself with GSK by giving the corporation unpublished research data from NIMH-funded projects at Emory. In turn, GSK and its medical education communications company, Scientific Therapeutics Information, Inc., incorporated Nemeroff’s privileged material in the training manual for PsychNet – a speaker program designed to build advocacy for GSK’s antidepressant drug Paxil. These issues go well beyond just failing to report income. They signify the corruption of academic psychiatry. Doesn’t Dr. Insel understand that?<br /><br />In his Commentary, Dr. Insel reported no financial disclosures. This is a good example of the problem that Dr. Insel doesn’t see. Many readers will interpret this Commentary from the Director of NIMH as the opening move in the attempted rehabilitation of Charles Nemeroff by his friends and cronies. Though Dr. Insel spoke in platitudes about the need for transparency as a solution, the spirit of transparency did not move him to disclose that Nemeroff is his former boss at Emory; that Nemeroff found a position for him when Insel was departing the intramural research program at NIMH; that Nemeroff lobbied for Insel’s appointment as NIMH Director; and that Insel appointed Nemeroff as an advisor soon after he moved to NIMH. These are pertinent conflicts of interest that readers of JAMA deserve to know about. <i>Quis custodiet ipsos custodes?</i><br /><br />Maybe Dr. Insel should stick to his knitting and resist the impulse to speak for academic psychiatry as a whole. A good place for him to start looking hard would be at the productivity and accounting of the once vaunted Emory-GSK-NIMH Collaborative Mood Disorders Initiative (Principal Investigator Charles B. Nemeroff; 5U19MH069056). One never knows what one will find when the rocks are turned over.

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR JAMA is out today with a Commentary by Dr. Thomas Insel, Director of the National Institute of Menta...

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