Fwd: Psychiatrists On the Take: the Focus of Government Investigations

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Lock them all up! *Very few* exceptions!=========ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYITwo prominent academic-psychiatrists--Jeffrey Bostic MD, director of schoolpsychiatry, Harvard-Massachusetts General Hospital, and Charles Nemeroff MD,the former chairman of psychiatry at Emory--are featured in currentgovernment investigations. The Boston Globe reports (below): that "a complaint unsealed last week in USDistrict Court in Boston, prosecutors allege that New York-based ForestLaboratories Inc. illegally marketed the drugs Celexa and Lexapro for use inchildren by paying kickbacks, including lavish meals and cash paymentsdisguised as grants and consulting fees, to induce doctors to prescribe thedrugs. They also say the company misled doctors and the public by failing todisclose the results of a negative study."Prosecutors' complaint states that from 1999 to 2006, Dr. Jeffrey Bostic,director of school psychiatry at Mass General, gave more than 350Forest-sponsored talks and presentations in 28 states, many of whichaddressed pediatric use of Celexa and Lexapro. According to the governmentcomplaint, the company paid Dr. Bostic more than $750,000 between 2000 and2006 for his presentations.Prosecutors said that: "Forest also paid Dr. Bostic to meet other physiciansin their offices in order to ease their concerns about prescribing the drugsfor off-label uses."Dr. Bostic became Forest's "star spokesman in the promotion of Celexa andLexapro for pediatric use."  Indeed, an unnamed Forest sales representativeis quoted saying, "Dr. Bostic is the man when it comes to child psych."The Emory student newspaper, Emory Wheel, reports: "The federal government may investigate former psychiatry chairman CharlesB. Nemeroff's consulting activities to gauge whether he fulfilled hisrequired time commitments as chief investigator of multiple research grantsfrom the National Institutes of Health (NIH)." From 2003 to 2008, Nemeroff served as the primary investigator on a $3.9 million joint grant between Emory, the NIH and pharmaceutical giantGlaxoSmithKline (GSK). Sen. Grassley alleged that Nemeroff received morefees from GSK than the maximum amount allowed."The in-house investigation focused on documents from 2000 to 2006 providedby GSK, the largest single payer, and led to a Dec. 5 press release thatsaid Nemeroff had received at least $800,000 in unreported outside income.Nemeroff stepped down as chairman in December but has continued in histeaching post; he is barred from participating in any sponsored researchgrants for the next two years at least.""Based on information that was made public last fall, Grassley states in hisletter that Nemeroff was a guest speaker who trained PsychNet doctors in theadvocacy of GSK's Paxil product. PsychNet is a program created by GSK totrain doctors in promoting Paxil. According to public documents, Nemeroffserved in this capacity in 2000."University President James W. Wagner said: the "real thrust of this [new investigation] was to question theconflict of commitment, which is something, very frankly, we need to lookinto." "the University will look at whether Nemeroff was overcommitted intime to the University, the NIH and GSK." "We have an ethical obligation, now that this matter has beenbrought, to understand the facts better, and we will, whether or not thereis an investigation by the OIG." Contact: Vera Hassner Sharavveracare212-595-8974http://www.boston.com/news/education/higher/articles/2009/03/06/us_cites_boston_psychiatrist_in_case_vs_drug_firmTHE BOSTON GLOBEUS cites Boston psychiatrist in case vs. drug firmComplaint alleges kickbacks to MDsBy Liz Kowalczyk  March 6, 2009Federal prosecutors say that a Massachusetts General Hospital psychiatristbecame a "star spokesman" in helping a pharmaceutical company promote itsdrugs for treating depressed children, even though the medications were notapproved for pediatric use by the US Food and Drug Administration.In a complaint unsealed last week in US District Court in Boston,prosecutors allege that New York-based Forest Laboratories Inc. illegallymarketed the drugs Celexa and Lexapro for use in children by payingkickbacks, including lavish meals and cash payments disguised as grants andconsulting fees, to induce doctors to prescribe the drugs. They also say thecompany misled doctors and the public by failing to disclose the results ofa negative study.In the 34-page complaint, prosecutors said that from 1999 to 2006, Dr.Jeffrey Bostic, director of school psychiatry at the hospital, gave morethan 350 Forest-sponsored talks and presentations in 28 states, many ofwhich addressed pediatric use of Celexa and Lexapro."Forest also paid Dr. Bostic to meet other physicians in their offices inorder to ease their concerns about prescribing" the drugs, the complaintsaid. Doctors are allowed to prescribe children drugs not approved by theFDA for pediatric use, a practice called "off label" use.The government said that Bostic became "Forest's star spokesman in thepromotion of Celexa and Lexapro for pediatric use" and that the company paidhim more than $750,000 between 2000 and 2006 for his presentations. Thecomplaint quotes an unnamed Forest sales representative as saying, "Dr.Bostic is the man when it comes to child psych."Bostic declined to be interviewed, but the hospital gave the Globe astatement describing him as a "highly regarded practitioner and educator inthe field of psychiatry." The hospital said Bostic cooperated with thegovernment, providing investigators with information about his speakingengagements."The United States complaint is brought against Forest Laboratories, not Dr.Bostic," the statement said. "The complaint consists of characterizationsand allegations by the United States, not established facts. In thosespeaking engagements, Dr. Bostic talked to fellow physicians about thetreatment of patients with various mental health conditions, not about oneor two specific drugs."On his Mass. General website on school psychiatry, Bostic outlines severaltreatments for depression in children and teenagers, including counselingand cognitive behavior therapy, as well as antidepressants. He mentionsLexapro and Celexa along with several other medications, and says, "There isno best medicine to treat depression."Dr. Michael Jellinek, president of Newton-Wellesley Hospital and chief ofchild psychiatry at Mass. General, said he has known Bostic for years. "Hehas absolute integrity," Jellinek said. "I have seen no bias in terms of anychoice of treatment or particular medication."The allegations against Forest are part of a legal and political backlashagainst potential conflicts of interest in medicine, particularly inpsychiatry. US Senator Charles E. Grassley, Republican of Iowa, has accusedanother Mass. General child psychiatrist, Dr. Joseph Biederman, of failingto tell Harvard Medical School until last March about most of the more than$1.5 million that the pharmaceutical industry paid him in consulting andspeaking fees between 2000 and 2007. Biederman has said in statements andletters to the Globe that he has been conscientious about requirements thathe disclose payments to his employers and that drug company money has notbiased his research.Harvard would not comment on whether Bostic disclosed his speaking fees,saying faculty disclosure forms are confidential.In a statement, Forest said it "is committed to adhering to the highestethical and legal standards, and off-label promotion and improper paymentsto medical providers have consistently been against Forest policy."Liz Kowalczyk can be reached at kowalczyk.  C Copyright 2009 The New York Times Company~~~~~~~~~ http://www.emorywheel.com/detail.php?n=26733 EMORY WHEELU.S. to Probe Emory, NemeroffBy Tiffany Han 3/07/2009The federal government may investigate former psychiatry chairman Charles B.Nemeroff's consulting activities to gauge whether he fulfilled his requiredtime commitments as chief investigator of multiple research grants from theNational Institutes of Health (NIH).Sen. Charles Grassley (R-Iowa), the ranking Republican on the Senate FinanceCommittee, sent a letter to the inspector general of the U.S. Department ofHealth and Human Services (HHS), prodding him to investigate theconflict-of-commitment matter. The letter, made public on Feb. 24, alsoquestioned whether Emory reported conflict-of-interest issues to the NIH ingood faith.When faculty apply for federal grants, which are a contract between theagency and the University, they request a salary amount in return forcommitting a percentage of their time to the research effort. Grassleycharged in the letter that Nemeroff could not have fulfilled his commitmentsto the NIH "while, at the same time, spending hundreds of days on the roadgiving promotional talks for, among others, drug companies." The NIHdeclined to comment.The Office of the Inspector General (OIG) is prohibited by law fromconfirming or denying a possible investigation and cannot comment on casesthat may be underway.A spokesperson for Grassley's office said the Feb. 24 letter was a form ofpublic declaration that an investigation would be conducted. Thespokesperson said Grassley's office has been in discussions with the OIGsince December.Emory's general counsel, Kent Alexander, said the University has notreceived word from the inspector general on whether any investigation wouldtake place. He said the University was not aware of the Feb. 24 letter untila Wall Street Journal reporter contacted Emory about it earlier this week.Since then, Emory has begun taking a close look at past records relating tothese new allegations, Kent said."We are taking all of this very seriously," Alexander said. "Whether theypursue it or not, we're certainly looking into it."Alexander said the University's own review could take an unspecified amountof time, adding that "the important thing is to be thorough, accurate andfair."The University already conducted an internal investigation last fall afterGrassley alleged that Nemeroff had misreported outside income and violatedUniversity and federal conflict-of-interest policies by exceeding limits seton outside consulting and speaking engagements. From 2003 to 2008, Nemeroffserved as the primary investigator on a $3.9 million joint grant betweenEmory, the NIH and pharmaceutical giant GlaxoSmithKline (GSK). Grassleyalleged that Nemeroff received more fees from GSK than the maximum amountallowed.The in-house investigation focused on documents from 2000 to 2006 providedby GSK, the largest single payer, and led to a Dec. 5 press release thatsaid Nemeroff had received at least $800,000 in unreported outside income.Nemeroff stepped down as chairman in December but has continued in histeaching post; he is barred from participating in any sponsored researchgrants for the next two years at least.In a Dec. 22 statement, Grassley commended Emory's "swift and sure-footedresponse" in dealing with the conflict-of-interest allegations, adding thatthe University has set an example for other research institutions to followand for the NIH to "hold up as the kind of standard it expects from thosereceiving federal research dollars."But in the Feb. 24 letter, Grassley questions whether Nemeroff's talks were"focused on substantive medical educational topics" that were not "productspecific or promotional," as the University had asserted in its Dec. 5statement. University officials have said that a review of lecture slidesand interviews with presentation attendees corroborated Nemeroff's assertionthat his conflicts of interest were purely financial and did not affect hisresearch or judgment regarding patients.Based on information that was made public last fall, Grassley states in hisletter that Nemeroff was a guest speaker who trained PsychNet doctors in theadvocacy of GSK's Paxil product. PsychNet is a program created by GSK totrain doctors in promoting Paxil. According to public documents, Nemeroffserved in this capacity in 2000.University President James W. Wagner said the "real thrust of this [newinvestigation] was to question the conflict of commitment, which issomething, very frankly, we need to look into." He said the University willlook at whether Nemeroff was overcommitted in time to the University, theNIH and GSK."We have an ethical obligation, now that this matter has been brought, tounderstand the facts better, and we will, whether or not there is aninvestigation by the OIG," Wagner said.The inspector general, currently Daniel R. Levinson, leads investigations toensure that federal programs under the HHS are run properly.Don White, a spokesperson for the OIG, said that after any investigation,the office presents its findings but does not act on them. Any possiblelegal or administrative action would be brought by a legal office or theinvolved federal agency, he said. White said that while he cannot comment onwhether an investigation is taking place, there is no timeline for a typicalinvestigation.- Contact Tiffany Han. FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. 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