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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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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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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Nemeroff, Seroquel, and ACCME

Nemeroff, Seroquel, and ACCME<br /><br />Roy Poses has <a href="http://hcrenewal.blogspot.com/2009/10/more-on-misleading-promotion-of.html">discussed</a> the atypical antipsychotic drug Seroquel (quetiapine) several times on this site, pointing out manipulation of clinical research results to enhance the appearance of efficacy, and suppression of studies with unfavorable results. I call this augmenting the marketed profile of the drug. Daniel Carlat has commented on published Seroquel data <a href="http://carlatpsychiatry.blogspot.com/2009/06/geodon-ineffective-for-bipolar.html">here</a> and ClinPsych <a href="http://clinpsyc.blogspot.com/search?q=Seroquel">here</a>.<br /><br />AstraZeneca, the marketer of Seroquel, has also been busy with continuing medical education (CME) programs that augment Seroquel’s profile. Last December 8, one such program went on line, aired by the provider CME Outfitters. The program’s title was “Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough.” The corporate logo for CME Outfitters is Education with Integrity. I will allow readers to decide if the company is meeting its mission statement in this respect.<br /><br />The key opinion leader engaged by CME Outfitters to discuss Seroquel and other atypical antipsychotic drugs was Charles Nemeroff of Emory University. He was joined by 2 KOLs-in-training, whom I will not name. The corporate sponsor that paid CME Outfitters and, indirectly, these presenters was AstraZeneca. I do not need to rehearse here the ethical issues that have surrounded Dr. Nemeroff for the past several years. Suffice it to say that, as a result of those issues, Dr. Nemeroff is no longer chair of the department of psychiatry at Emory University, he is no longer editor-in-chief of the ACNP journal Neuropsychopharmacology, he was removed from involvement with ongoing federally funded research grants at Emory University, and he was put on a short leash by the Emory administration.<br /><br />On December 23, 2008 I filed a formal complaint about Dr. Nemeroff’s program with ACCME. My bill of particulars was lengthy, detailed, and backed up by extensive<br />materials. In due course, ACCME investigated the complaint and found that the program did violate ACCME standards. With respect to content, ACCME determined that Dr. Nemeroff’s program lacked sufficient information about possible adverse effects of treatment with atypical antipsychotic drugs; and failed to emphasize sufficiently the efficacy of alternative treatments. With respect to commercial bias, ACCME determined that bias existed as a result of the absence of contrasting therapy data, and through downplaying the drawbacks related to treatment with atypical antipsychotic drugs in depressed patients.<br /><br />Following these findings by ACCME, the provider was notified of the violations in early September 2009, and the program was removed from the provider’s website. The sanitized statement of violations determined by ACCME does not capture the nuances of deceit, ineptitude, and deficient educational content in Dr. Nemeroff’s program. One remarkable example was Dr. Nemeroff’s citation of data, from one of his own publications, that were previously retracted. Did he think no one would notice?<br /><br />A second example involved biased presentation of the sponsor’s data for Seroquel. Two doses of Seroquel (150 mg and 300 mg) were tested. Only the results for the 300 mg dose were statistically significant. Nevertheless, in the video presentation one of the junior presenters stated very clearly that there was “significant improvement in both response and remission with both doses” of Seroquel. That is a falsification of the scientific record. That falsification does not meet ACCME requirements for fair, balanced, truthful, and honest teaching. As moderator, Dr. Nemeroff was required to correct this false statement made by his junior assistant, but Dr. Nemeroff failed to do so.<br /><br />The negative findings and sanction by ACCME against Dr. Nemeroff’s program are welcome, though I have to say it took ACCME an inordinately long time to complete their work. I also presented ACCME with several follow-on questions, which the Council is now considering. These are:<br /><br />• Did ACCME notify the presenters that their program violated ACCME policies? If not, why not?<br /><br />• Will CME credits be clawed back from physicians and other professionals who obtained credits through the noncompliant program? If not, why not? I believe this would be an effective form of negative feedback to the provider and the presenters.<br /><br />• Does ACCME have a process to require the provider and presenters to ascertain whether any patients were injured as a result of the violations that created biased and deficient information in this program? If not, why not?<br /><br />• Does ACCME require the provider to notify physicians and other professionals who completed the noncompliant program that the provider was sanctioned for violation of ACCME standards? If not, why not?<br /><br />• Does ACCME require the provider to furnish corrective materials to such professionals in order to remedy the bias and incompetence to which they were subjected through violation of ACCME standards, and thereby to remove potential danger to future patients? If not, why not?<br /><br />• Why did ACCME allow the noncompliant program to remain available long after the complaint was filed? I suggest that ACCME needs to place a hold on programs that are subject to active complaint. Had such a policy been in effect in December 2008, the violating program would not have been re-aired by the provider in early 2009, it would not have remained on-line for 9 months, and the damage to the continuing education community would have been contained.<br /><br />• Will ACCME issue a public listing of sanctions it has enforced against providers and presenters? If not, why not? State medical boards do exactly that in relation to physicians and other professionals who violate standards of practice.<br /><br />• Finally, I reminded ACCME that its primary constituents are patients, physicians and other professionals, not commercial or academic CME providers. It seems to me that ACCME was altogether too laissez-faire and dilatory in the way it handled this matter. At the time of my initial complaint last December, I requested expedited review precisely because additional airings of this violating program were scheduled.<br /><br />The good news is that ACCME seems to have got the message that things need to change. As one of their officers wrote to me recently, “We sincerely appreciate the time and effort you have put into participating in our complaints and inquiries process. You have raised important issues that the ACCME will review and address.” I await their next communications on the remaining questions.<br /><br />As for Dr. Nemeroff, he is yesterday’s news. The adverse findings by ACCME about his program serve as a reminder to corporate sponsors and CME companies that Dr. Nemeroff is so compromised by now that he has lost effectiveness as a front man for Pharma. Indeed, he is so toxic that he now glows in the dark.

Nemeroff, Seroquel, and ACCME

Nemeroff, Seroquel, and ACCMERoy Poses has discussed the atypical antipsychotic drug Seroquel (quetiapine) several times on this site, pointing out manipulation of clinical research results to enhance…

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A Blogger That Dares Not Speak His University's Name

Dr Douglas <span id="SPELLING_ERROR_0" class="blsp-spelling-error">Bremner</span> is a Professor of Psychiatry and Radiology at Emory University, and <a href="http://userwww.service.emory.edu/~jdbremn/index.html">Director of the University's Clinical <span id="SPELLING_ERROR_1" class="blsp-spelling-error">Neuroscience</span> Research Unit.</a> He has also written a book critical of the <span id="SPELLING_ERROR_2" class="blsp-spelling-corrected">pharmaceutical</span> industry (<a href="http://www.beforeyoutakethatpill.com/index.html"><em>Before You Take That Pill</em></a>), and writes a blog (also called <a href="http://www.beforeyoutakethatpill.com/">Before You Take That Pill</a>) that is also skeptical about certain aspects of current psychiatric dogma. Inside Higher Education <a href="http://www.insidehighered.com/news/2009/07/01/emory">reported</a> that Emory University can apparently no longer bear to have its name mentioned in Dr <span id="SPELLING_ERROR_3" class="blsp-spelling-error">Bremner's</span> blog:<br /><br /><blockquote><br />Emory University has been accused repeatedly over the last year of looking the other way while one of its prominent physicians built extremely close ties to the <span id="SPELLING_ERROR_4" class="blsp-spelling-error">pharmaceutical</span> industry and -- critics charge -- failed to adequately report those ties as required by university and federal regulations.<br /><br />But what if you are an Emory professor who happens to differ with the <span id="SPELLING_ERROR_5" class="blsp-spelling-error">pharmaceutical</span> industry? Then, it appears, Emory watches you closely -- and if you are a blogger, <em>the university can tell you that you must remove the Emory name from your Web site</em>. That's why a recent post on the J. Douglas <span id="SPELLING_ERROR_6" class="blsp-spelling-error">Bremner's</span> blog Before You Take That Pill is called 'I Am Removing the Name of My University From This Blog.'<br /><br />In the post, he notes that he was recently ordered to remove the Emory name both by the interim chair of psychiatry and behavioral sciences, and by the medical school's executive associate dean for faculty affairs. In the letters, which he provided to Inside Higher Ed, they tell <span id="SPELLING_ERROR_7" class="blsp-spelling-error">Bremner</span> to remove Emory's name, logo and letterhead from his blog because none of them can be used for 'non-Emory business.' He was also told to report on when he had removed Emory from his blog.<br /><br />The letters cite complaints that the university received about a blog post <span id="SPELLING_ERROR_8" class="blsp-spelling-error">Bremner</span> made in January in which he criticized the eviction of a man with bipolar disorder who was being forced out of his apartment for smoking. <span id="SPELLING_ERROR_9" class="blsp-spelling-error">Bremner</span> made his point in the form of a mock letter 'To Whom It May Concern' giving his blessing for the man to continue to smoke. According to <span id="SPELLING_ERROR_10" class="blsp-spelling-error">Bremner's</span> Emory superiors, complaints they received suggested that he was making 'clinical <span id="SPELLING_ERROR_11" class="blsp-spelling-error">recommendations</span> for a patient you do not know and have never examined,' and these postings made them feel the need to tell him to stop using the Emory name. </blockquote><br />And even more concerning:<br /><br /><blockquote><br /><a href="http://whsc.emory.edu/home/news/media-team/bio-sarah-goodwin.html">Sarah E. Goodwin</a>, director of media relations for Emory Health Sciences, said that Emory's objection to the use of its name in non-official places was 'across the board' and not related to the content of <span id="SPELLING_ERROR_12" class="blsp-spelling-error">Bremner's</span> blog. When told about other blogs or Web sites where Emory professors' university affiliation was noted on non-Emory business, she said she didn't know why that was the case but insisted that the ban was 'across the board.'<br /><br />She noted that <span id="SPELLING_ERROR_13" class="blsp-spelling-error">Bremner</span> has been 'blogging for some period of time,' and that<em><strong> 'if you read it over a long period of time, you can see comments he makes that may be of concern.'</strong></em> She declined to identify those comments.<br /></blockquote><br />So there you have it. It appears that faculty members, even senior faculty at Emory who make comments "<em>that may be of concern</em>" to an <a href="http://whsc.emory.edu/home/news/media-team/bio-sarah-goodwin.html">Assistant Vice President for Health Sciences, and Director, Media Relations</a>, are not supposed to identify themselves as Emory faculty. This is the sort of policy one might expect from certain <span id="SPELLING_ERROR_14" class="blsp-spelling-corrected">corporations</span>. But Emory is a university. It <a href="http://www.emory.edu/home/about/index.html">proclaims</a> it<br /><br /><blockquote><br />is an <em>inquiry-driven, ethically engaged</em> and diverse community whose members work <span id="SPELLING_ERROR_15" class="blsp-spelling-error">collaboratively</span> for positive <span id="SPELLING_ERROR_16" class="blsp-spelling-error">transformation</span> in the world through <em>courageous leadership in teaching, research, scholarship, health care and social action</em>.<br /></blockquote><br />It proclaims its strategic plan is entitled:<br /><br /><blockquote><br /><em><strong>Where Courageous Inquiry Leads</strong></em><br /></blockquote><br /><br />We can see where courageous inquiry leads at Emory. It leads to University executives attempting to censor faculty blogs when they included "concerning" remarks. As Inside Higher Education noted, Emory executives have not attempted to have other faculty <span id="SPELLING_ERROR_17" class="blsp-spelling-error">bloggers</span> remove references to the University, or to the <span id="SPELLING_ERROR_18" class="blsp-spelling-error">bloggers</span>' faculty status from their writing. Presumably, those <span id="SPELLING_ERROR_19" class="blsp-spelling-error">bloggers</span> were more politically correct.<br /><br />We have often written about the <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of medical research </a>that is now a plague upon medicine, and the most dire threat to the evidence-based medicine approach. The research most likely to be suppressed is that which offends vested interests, <span id="SPELLING_ERROR_20" class="blsp-spelling-corrected">particularly</span> vested interests in selling particular health care goods or services. On the other hand, the Foundation for Individual Rights in Education (<a href="http://www.thefire.org/">FIRE</a>) for years has been fighting to uphold free speech and academic freedom on campus, but has mostly dealt with threats to politically or socially unpopular speech.<br /><br />This case seems to blend these these different kinds of threats to free speech and academic freedom. It once again shows how elite <span id="SPELLING_ERROR_21" class="blsp-spelling-corrected">universities</span> <span id="SPELLING_ERROR_22" class="blsp-spelling-corrected">increasingly</span> are run like for-profit <span id="SPELLING_ERROR_23" class="blsp-spelling-corrected">corporations</span>, putting the <span id="SPELLING_ERROR_24" class="blsp-spelling-corrected">prerogatives</span> of managers ahead of the individual rights of faculty and students, and putting the mission of the university, to discover and disseminate the truth in the spirit of free enquiry, in the trash.<br /><br />Dr <span id="SPELLING_ERROR_25" class="blsp-spelling-error">Bremner's</span> own comments in his blog are <a href="http://www.beforeyoutakethatpill.com/index.php/2009/07/01/is-there-such-a-thing-as-academic-freedom/">here</a>. He concluded that Emory managers were "thinking more like a corporation than a university, where the free exchange of ideas, regardless of the perceived value or political correctness of those ideas, is held to the highest standard."<br /><br />See also <a href="http://www.margaretsoltan.com/?p=14475">comments</a> by Prof Margaret <span id="SPELLING_ERROR_26" class="blsp-spelling-error">Soltan</span> in the University Diaries.<br /><br />ADDENDUM (15 July, 2009) - Emory has backed down, and will once again allow Dr Bremner to identify himself as a faculty member. See <a href="http://www.beforeyoutakethatpill.com/index.php/2009/07/13/we-won-university-backtracks-on-ban-of-use-of-name-on-this-blog/">this post </a>by Dr Bremner, and <a href="http://www.thefire.org/article/10859.html">this post </a>on The Torch (the FIRE blog).

A Blogger That Dares Not Speak His University's Name

Dr Douglas Bremner is a Professor of Psychiatry and Radiology at Emory University, and Director of the University's Clinical Neuroscience Research Unit. He has also written a book critical of the phar…

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INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

<div align="left"><br />INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST<br /><br />Today we saw a new marker laid down in the arena called Conflict of Interest (COI). The Institute of Medicine of the National Academy of Sciences issued a <a href="http://policymed.typepad.com/files/medical-coi-full-report-4-28-09.pdf">report</a> of its Committee on Conflict of Interest in Medical Research, Education and Practice. The report is comprehensive, even exhaustive, running to 353 pages. Gardner Harris in the New York Times <a href="http://www.nytimes.com/2009/04/29/health/policy/29drug.html?_r=1">today</a> calls it “scolding,” “stinging,” and “damning.” The recommendations go well beyond any proposed in the recent past by medical schools or by other professional organizations. The NYT quoted David Rothman, president of the Institute on Medicine as a Profession at Columbia University: “With the I.O.M.’s endorsement, issues that were once controversial now are indisputable. Conflicts of interest in medicine are no longer acceptable.”<br /><br />It will take some time for the field to digest the scope of the IOM recommendations. It will take even longer for the new standards to be implemented. For now, I offer just a few observations.<br /><br />First, if the IOM hopes for maximum credibility then it might ought want to do some housecleaning. A few years ago I fired a shot across the bow of the IOM concerning COI. [Can the Institute of Medicine Review the FDA? Nature Medicine 11, 369 (1 April 2005) doi:10.1038/nm0405-369] Nothing much changed, and in the following years, national scandals erupted involving several of the issues I had highlighted. Prominent IOM members, who were well known to be poster boys for COI, were exposed by Senator Charles Grassley (R-Iowa). Their embarrassing behaviors included incomplete financial disclosures and noncompliance with NIH policy on financial conflict of interest. The exposés included Emory’s Charles Nemeroff and Stanford’s Alan Schatzberg. In both cases, administrative rearrangements have now been implemented. The case of Dr. Nemeroff has been referred by Senator Grassley to the Inspector General of the Department of Health and Human Services. It is perhaps no accident that Dean Claudia Adkison of Emory and Dean Philip Pizzo of Stanford were included as external reviewers of the draft IOM report. Their insights would have been invaluable.</div><br /><div align="left"><br />Another ongoing embarrassment for the IOM is Lester Crawford. He was the FDA Commissioner who resigned abruptly in 2005 and later pleaded guilty to criminal conflict of interest. He had been charged with falsely reporting information about his stock holdings in companies he was in charge of regulating. He received a sentence of three years of supervised probation and a fine of about $90,000. He is now senior counsel with a health care lobbying firm in Washington, DC. The Institute of Medicine does not help its image by continuing the membership of such a compromised individual.</div><br /><div align="left"><br />As the Emory-Nemeroff and Stanford-Schatzberg cases unfolded it appeared that the respective institutions had themselves contributed to the problems, either through inaction or through studiously nontransparent procedures on disclosure. Stanford, for instance, apparently did not require faculty members to report the proceeds of stock sales, and when challenged the university invoked on-line financial reporting services and SEC filings as a sufficient substitute. Not surprisingly, because Stanford didn’t know about Dr. Schatzberg’s realized gain of some $109,000 from sale of founder’s stock in his biotech start-up company, Corcept Therapeutics, this information was not reported to NIH.<br /><br /><strong>Recommendation 4.1</strong> One of the IOM’s recommendations applies particularly to the Stanford-Schatzberg case. Recommendation 4.1 addresses the boundary between academia and commerce in the case of research involving human subjects. Here is the specific language:<br /><br /><em>“Academic medical centers and other research institutions should establish a policy that individuals generally may not conduct research with human participants if they have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research. Exceptions to the policy should be made public and should be permitted only if the conflict of interest committee (a) determines that an individual’s participation is essential for the conduct of the research and (b) establishes an effective mechanism for managing the conflict and protecting the integrity of the research…”</em> (page S-14).<br /><br />Last year I posted <a href="http://hcrenewal.blogspot.com/search?q=Schatzberg">several times</a> about this issue in the Stanford-Schatzberg case. It is gratifying now to see the IOM affirm the importance of the boundary. The activities declared off-limits by the IOM include not only <em>“recruiting subjects; obtaining informed consent; assessing the clinical end points;”</em> but also <em>“analyzing data; or writing the results, conclusions, and abstracts for publications reporting the findings of the study.”</em> (page 4-17). In Stanford’s earlier plan for managing the conflict and protecting the integrity of the research, Dr. Schatzberg was free to engage in the latter group of activities. Indeed, his hands were all over the project when it came to responding to scientific critiques, managing the climate of professional opinion, attacking and threatening critics, promoting his company’s interest through review articles and press releases, slipping unpublished and non-peer-reviewed commercial data into academic reviews, and generally conducting commercially slanted public relations through academic outlets.<br /><br />When Stanford adopts the IOM recommendations, such activities will be blocked. As I <a href="http://hcrenewal.blogspot.com/2008/07/managing-conflicts-of-interest-at.html#links">stated</a> last year, “Review articles that assess a field and synthesize data form a crucial part of science that has to be off-limits to Dr. Schatzberg just as much as assessing patients in one of his clinical trials would be.”</div><br /><div align="left"><br />We should congratulate the IOM committee members for their work, and we hope to see the field embrace their recommendations.<br /><br />Bernard Carroll. </div><div align="left"></div><div align="left"><strong>UPDATE 04-30-2009:</strong> The link provided earlier for the IOM report document is no longer operative. Here is where to go now for a copy of the report. This time it will cost you.</div><div align="left"><a href="http://www.nap.edu/catalog.php?record_id=12598">http://www.nap.edu/catalog.php?record_id=12598</a> </div>

INSTITUTE of MEDICINE REPORT on CONFLICT of INTEREST

INSTITUTE of MEDICINE REPORT on CONFLICT of INTERESTToday we saw a new marker laid down in the arena called Conflict of Interest (COI). The Institute of Medicine of the National Academy of Sciences is…

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