Fwd: Charles Nemeroff Deposed from Psychiatry Chairmanship

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ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIA "good news" item, thanks to the efforts of Sen. Charles Grassley, who ispressing academic institutions that receive government grants to enforceconflict of interest requirements, or risk those multi-million dollars intaxpayer grants: Charles Nemeroff Removed As Emory Psychiatry Chair.Dr. Nemeroff was repeatedly discredited in the national press--e.g., TheWall Street Journal, The New York Times--for promoting treatments whosesafety and efficacy were in doubt; for professional misconduct by signingoff on ghostwritten reports which he published in a journal of which he wasthe editor; and by violating federal conflicts of interest rules by failingto disclose his numerous financial ties to the manufacturers of drugs anddevices he promoted. http://hcrenewal.blogspot.com/Dr. Nemeroff's conduct openly made a mockery of "peer review" andprofessional ethical standards. What is especially troubling is that hisconduct is acknowledged to be emblematic of academic psychiatry as a whole.Following an expose in The Wall Street Journal (2006), 45 otherpsychiatrists rush to his defense in print. See letter in defense ofNemeroff:  http://www.ahrp.org/cms/content/view/345/27/The same year, the American Psychiatric Association,  the National Instituteof Mental Health, and the American Association of Chairs of Departments ofPsychiatry awarded Dr. Nemeroff two awards (to compensate him for his publicdisgrace ?) http://pn.psychiatryonline.org/cgi/content/full/41/15/17 See:  http://ahrp.blogspot.com/2006/11/psychiatry-news-high-cost-of.html andhttp://ahrp.blogspot.com/2007/02/pharma-spin-and-child-suicide-rates.htmlFollowing the documented evidence uncovered by Sen. Grassley (Oct. 2008),New York Times blogger, Judith Warner wrote: "Dr. Charles Nemeroff is one of the most influential psychiatrists. Dr.Nemeroff's machinations are but another iteration of the ever-unfolding sagaof greed and how the deregulation of absolutely everything has brought ourcountry to this painful season of reckoning. Because Nemeroff's story -which is hardly unique - belongs uniquely to this time in our nation'shistory. It is a product of legislative and cultural changes that havealtered the practice of medicine, the work of research universities and therelationship between those universities and industry. And it is marked, likeso much of what's gone off the rails in our era, by the failure of ourgovernment to step in to protect citizens.""Nemeroff didn't bring down any banks, didn't freeze the American creditmarkets, hasn't plunged the world economy into recession. But his extensive,excessive and untransparent ties to the pharmaceutical industry are all toocommon, unfortunately, among his cohort of "thought leaders" in psychiatryand other medical specialties. And these relationships have led to adangerous crisis of confidence in the basic integrity and validity ofAmerica's medical research."In January, 2008, Howard Brody, MD, PhD, Director, Institute for the MedicalHumanities, University of Texas, (the author of "HOOKED: ETHICS, THE MEDICALPROFESSION, AND THE PHARMACEUTICAL INDUSTRY") posed the following questions:"How can the field of psychiatry hold up its head and act as if its membersare professionals, so long as Nemeroff remains an "opinion leader" in goodstanding? How can Emory University justify allowing such an individual toremain as a department chair?  How can 45 other psychiatrists rush to hisdefense in print without having to put paper bags over their heads? Whatdoes this say about all of us in medicine, who claim to have some sort ofconnection with professionalism and ethics?"http://brodyhooked.blogspot.com/search?q=emory+university+justifyThe agenda for the 47th Annual Meeting (Dec. 2008) of the American Collegeof Neuropsychopharmacology, psychiatry's most influentialpharmaceutical-supported association whose members are by invitation only,lists Charles Nemeroff as a presenter at 7 events.  The ACNP lists thefollowing sponsors of the meeting: Janssen Pharmaceutica--MerckPharmaceuticals--Eli Lilly and Company--Novartis Pharmaceuticals--OtsukaPharmaceuticals--Pfizer Global Research & Development--Wyeth Pharmaceuticalshttp://www.acnp.org/asset.axd?id=2c8dfd46-0c21-4559-83e4-5465a0d3b7bcAs Ed Silverman of Phamalot points out, the removal of Dr. Nemeroff as chairof psychiatry "comes after Emory was embarassed by the Senate investigation,which focuses on alleged conflicts of interest among academics who receivepayments from drugmakers while simultaneously receiving NIH grants. Theprobe found Emory was aware Nemeroff failed to properly disclose paymentsbut did nothing(http://www.pharmalot.com/2008/10/emory-fiddled-while-nemeroff-earned/ ).Now, Emory's own investigation found Nemeroff received more than $800,000from Glaxo, which paid Nemeroff more than any other drugmaker, but he neverreported the fees. There were more than 250 speaking engagements between2000 and 2006."http://www.pharmalot.com/2008/12/nemeroff-removed-as-emory-psychiatry-chair/As the Atlanta Journal Constitution reported, "Nemeroff was paid by otherdrug companies, but the university only reviewed payments fromGlaxoSmithKline because it was his largest single payer, and the companycooperated with Emory."http://www.ajc.com/search/content/metro/dekalb/stories/2008/12/23/Emory_punishes_Nemeroff.htmlEmory's psychiatry department was the recipient of $22 million in NIMHgrants. So, why, one might ask, did NIMH officials turn a blind eye toviolations of federal conflict of interest regulations??Below , a letter from Emory University to the National Institute of MentalHealth outlines determinations that allow Dr. Nemeroff, among otherlucrative relationships, to serve on "no more than four scientific advisoryboards."  What's more the university, whose administrators had beencomplicit in turning a blind eye to Dr. Nemeroff' :financial dealings--evenwhen his misconduct was documented and publicly disclosed--leave it to thefox to "track" himself.    "Dr. Nemeroff is responsible for tracking his personal external professionaleffort, ensuring that it does not exceed that allowed by School policy, andhaving records available to the Dean's Office on request."Emory insist it has found no evidence that Nemeroff's outside speakingactivities affected clinical care for patients enrolled in clinical trials,and no evidence his activities biased scientific research. That claim is refuted by an in-depth critique by Dr. Bernard Carroll, formerchair of psychiatry at Duke, who dissected a report co-authored by Dr.Nemeroff, published in the November 2006 issue of the journalNeuropsychopharmacology (NPP), the house journal of the American College ofNeuropsychopharmacology (ACNP).  The lead author was Mark H. Rapaport, MDfrom Cedars-Sinai Medical Center in Los Angeles. A co-author was thecontroversial Martin Keller, MD from Brown University, who co-authored thediscredited GlaxoSmithKline pediatric Paxil trial, and the senior (last)author was Dr. Nemeroff, who was also editor in chief of the journal.Dr. Carroll provides a careful analysis demonstrating that the claims madeby the authors about the supposed efficacy of Janssen's antipsychotic,risperidone (Risperdal) for nonresponding depression, is unsupportable. Andhe reminds readers that "Dr. Nemeroff is a long-time KOL [key opinionleader] for Janssen's efforts to create a favorable climate of opinion forrisperidone in depression.""He fronted for the company in presentations of the risperidone infomercialat the ACNP meeting in 2004, in a Janssen-financed journal supplement in2005, and in co-authoring the 2006 infomercial in his own journal, NPP.Readers will recall that Dr. Nemeroff ran into problems in 2003 for failingto disclose his financial conflicts of interest in a Nature publication, andagain in 2006 for failing to disclose his commercial ties in a reviewarticle he co-authored favorable to the Cyberonics vagus nerve stimulation(VNS) device for depression (also published in the journal he edited). As aresult of that episode, Dr. Nemeroff resigned as editor of NPP, but notbefore publishing the infomercial mentioned above on risperidone indepression. One wants to ask whether these publications that he co-authoredwent through a credible peer review in Dr. Nemeroff's journal. One alsowants to ask whether Dr. Nemeroff abused his position as editor to giveproduct placement to his corporate clients Cyberonics and Janssen. And onewants to ask why the risperidone infomercial was published in NPP, giventhat the data had already been published by Dr. Nemeroff himself in anotherjournal, in a special supplement financed by Janssen."http://hcrenewal.blogspot.com/2008_01_01_archive.html So, both Emory University and Dr. Nemeroff have a long way from coming cleanEqually egregious--perhaps more so inasmuch as Harvard University hasremained silent about the misconduct by its most influential professor ofpsychiatry, Dr. Joseph Biederman, whose financial conflicts of interest werealso uncovered by Sen. Grassley's investigation.Indeed, Johnson & Johnson Risperdal documents detail the concealed fees paidfor Dr. Biederman's services:http://psychrights.org/Research/Digest/NLPs/Risperdal/081112Opp2BiedermanQuash-Seal.pdfDr. Biederman is "credited" with a 40-fold (that's 4,000%) increase the useantipsychotics in children.http://www.nytimes.com/2008/11/25/health/25psych.html?em He bears major responsibility for the harm suffered by children who wereforced to ingest these exceedingly toxic drugs. A searing case example is 4-year old Rebecca Riley, who was prescribed atoxic drug cocktail and died of drug toxicity. http://ahrp.blogspot.com/2007/02/4-year-old-rebecca-riley-casualty-of.html But unlike Dr. Nemeroff who has been deposed from his chairmanship by EmoryUniversity, Dr. Biederman continues to hold sway as the influentialprofessor of psychiatry at Harvard Medical School, and Chief of Clinical /Research Programs in pediatric psychopharmacology at Massachusetts GeneralHospital. http://ahrp.blogspot.com/2008/12/expert-or-pharma-shill.html Contact: Vera Hassner Sharavveracare212-595-8974http://www.pharmalot.com/wp-content/uploads/2008/12/emory-letter-to-nih.pdfDecember 22, 2008Mr. Joseph EllisDirector, Office of Policy for Extramural Research AdministrationOffice of Extramural Research AdministrationNational Institutes of Health, DHHSOne Rockledge Ctr., 35136705 Rockledge Dr.Bethesda, MD 20892-7974Ellisj1RE: Follow-Up Information Regarding Charles Nemeroff, M.D.Dear Mr. Ellis:In light of Emory University's review of concerns raised regarding Dr.Charles Nemeroff, the Institution has made the following determinations.These are effective immediately.1. Chairmanship. Dr. Nemeroff will not be reinstated as Chair of Psychiatryor as Service Chief for the Department/Clinical Service of Psychiatry andBehavioral Sciences. He will continue to report to the interim Chair ofPsychiatry and then to a permanent successor and will be expected to carryout his academic, research, clinical, teaching and other duties in completecompliance with School of Medicine and University policies as they now existor may be changed in the future.2. NIH grants and Other Sponsored Research. Emory will not submit any NIH orother sponsored grant or contract requests in which Dr. Nemeroff is listedas an investigator or have any other role for a period of two yearsfollowing the date he stepped down as Chair of the Department of Psychiatry,October 3, 2008. In the fall of 2010, Emory will reevaluate the situationand determine whether he may resume his applications for research support.3. Cooperation. Dr. Nemeroff will be expected to continue to cooperate fullywith Emory as we conduct or participate in remaining and additionalinvestigations that may be necessary and respond fully and truthfully to anyfurther inquiries from Emory, the NIH, Senator Grassley, or other agenciesand external bodies.4. External compensation. Dr. Nemeroff must report to the Dean's Office allproposed personal external compensated arrangements (whether written orverbal) for review and approval before he agrees to, sign, or engage in thearrangement. ["Compensation" in this use refers to any form of remunerationor quid pro quo.] He must also report to the Dean's Office receipt of allother current and future external compensation related in any way to hisprofessional areas, regardless of the rationale for such compensation,within ten days after receipt. Dr. Nemeroff must submit to the Dean's Officea complete current list of his equity interests and options in externalcompanies, including the amount, their values, and information about thecompanies and their products. He may not hold equity interests or optionsthat cause any conflict of interest with his Emory duties.5. Relationships with industry:a. Dr. Nemeroff may continue to serve as a member of no more than fourscientific advisory boards, all of which must be reviewed in advance and aresubject to approval by the Dean's Office, as required by University andSchool of Medicine policies; focused on advancing science and clinical carefor the benefit of the public; and clearly and appropriately beneficial tohim and the institution's academic standing and reputation. Hiscompensation, if any, for such board service must be at no more than fairmarket value and must be less than $10,000 per board in any twelve monthperiod. Dr. Nemeroff must report this activity annually in the School'son-line reporting system. His board service may not be focused onpromotional activities for the company, and may not pose a conflict ofinterest or commitment in any of his faculty duties now or in the future.b. Dr. Nemeroff may interact with biomedical companies in non-compensatedarrangements to further science and clinical care to benefit the public, butany such arrangements will be submitted to the Dean's Office in advance forreview and approval. These non-compensated arrangements may not be forpromotional, commercial activities for the company.6. Speaking:a. Meetings and conferences. Dr. Nemeroff may accept invitations to lectureat other academic institutions and at the meetings and conferencesofficially hosted by scientific and clinical professional societies, as longas the agreements are reviewed and approved in advance and his absence isapproved by his Department Chair in advance. He may be reasonablycompensated for these presentations and reimbursed for reasonable travelexpenses as long as the compensation is provided to him by the academic hostor professional society and not from an industry sponsor. He is required toreport any payments for these and all outside activities to the Dean'sOffice.b. Other events. Dr. Nemeroff is prohibited from speaking for compensationat any other event unless it is an ACCME-accredited educational event hostedby an academic institution or a professional society. If he speaks at anACCME-accredited educational event, his honorarium may not exceed $2,500 perevent, plus reasonable travel expenses. He is required to report and submitall proposed agreements for these speaking activities in advance to theDean's Office for review and approval.c. CME hosted by Dr. Nemeroff. CME courses that Dr. Nemeroff organizesand/or for which he is the course director must by ACCME-accredited andfully compliant with School CME policies. Any funds from industry tosubsidize such courses will be sought by the School of Medicine DevelopmentOffice and managed by the CME Office, not by him directly. The contracts forindustry support, if any, and the budgets will be reviewed and approved bythe CME Office, in consultation with the Dean's Office if necessary.7. Gifts. Dr. Nemeroff may not directly solicit or accept philanthropiccontributions or other gifts in any form from industry in support of hispersonal academic activities or those of other faculty. Any proposed donorgift agreements will be reviewed by the School of Medicine DevelopmentOffice and Dean's Office. Gift accounts will not be managed directly by Dr.Nemeroff and will not be placed in an Emory account over which he hasspending authority, except as expressly approved by the Dean's Office.8. Travel expenses. Dr. Nemeroff may accept compensation and reasonablereimbursement for travel expenses from the NIH and other federal agenciesfor serving on study sections, review panels, commissions, and similaractivities, as long as this is reported to Emory.9. Emory Healthcare policies. Dr. Nemeroff is required to adhere to EmoryHealthcare policies on prescribing practices, vendor relationships, conflictof interest reporting, and receipt of pharmaceutical samples.10. Conflict of commitment. Dr. Nemeroff is responsible for tracking hispersonal external professional effort, ensuring that it does not exceed thatallowed by School policy, and having records available to the Dean's Officeon request. All such external activities will be subject to approval by hisdepartment chair and the Dean's Office.These determinations are based on the information available to Emory at thistime. Any additional information may result in Emory's taking furthermeasures, as appropriate.Please feel free to contact me if you have any questions regarding thismatter.Sincerely,David L. Wynes, Ph.D.Vice President for Research Administration_____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.