Fwd: Harvard Child Psychiatrist, Biederman: After Me, There is Only God_Sworn Deposition

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ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure,and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIDr. Joseph Biederman, the influential Harvard child psychiatrist who is atthe center of controversy following revelations by Sen. Grassley'sinvestigation that uncovered the doctor's undisclosed financial relationswith Janssen Pharmaceutica--in violation of federal conflict of interestdisclosure regulations, was deposed on Feb. 26, 2009, by attorneys involvedin a series of lawsuits against antipsychotic drug manufacturers.Dr. Biederman proclaimed that the rank after the one he holds--namely, fullprofessor at Harvard--there was only GOD.  "Did you say God?" Mr. Trammell asked. "Yeah," Dr. Biederman said.   Dr. Biederman, an ardent advocate of prescribing powerful psychotropic drugsfor children, is credited with --first, expanding the ADHD (attentiondeficit hyperactivity disorder) in children, then catapulting bipolardisorder, a rare adult psychiatric disorder, which was unrecognized inchildren, into an American children's epidemic that has hugely enrichedneuroleptic (a.k.a antipsychotic) drug manufacturers who paid Dr. Biedermanhandsomely. Dr. Biederman stated that he published 650 studies; in the decade of the1990s, he was the fourth highest producer of "high-impact" papers inpsychiatry (based on being highly cited by others according to the citationindex): between 1995--2005 his papers were cited 6,866 times by otherscientists--he was the most influential child psychiatrist in the world.But here's the rub, The New York Times reports (below) that Dr. Biedermanpromised Johnson & Johnson that his "planned studies of [the company's]medicines in children would yield results benefiting the company."A series of slides, all prepared by Dr. Biederman--according to his sworntestimony--are revealing as they raise serious doubts about the scientificand ethical integrity of his oeuvre. One of Dr. Biederman's slides referred to a proposed trial in preschoolchildren of Risperdal (risperidone) an antipsychotic drug made by Johnson & Johnson /Janssen. The slide stated that the trial "will support the safetyand effectiveness of risperidone in this age group."Another slide listing "Key Projects for 2005" mentioned a planned study inadolescents of Concerta, a stimulant manufactured by Johnson & Johnson. Thestudy will "extend to adolescents positive findings with Concerta inA.D.H.D. N.O.S. in adults." The Times quotes Josephine Johnston, a research scholar at the HastingsCenter, a bioethics research institute, who said the documents "raisequestions about how well-designed Dr. Biederman's trials were in that hepromised a result to his funders."  "It's another shadow over his work," Ms.Johnston said.Indeed, Dr. Biederman's projected, predetermined conclusion is NOTscience--it is a corruption of science and medical ethics. Ethical researchinvolving human subjects requires doubt about the outcome--it's calledequipoise. It is not only scientifically unsound, but unethical to use humanbeings--including innocent little children who are non-consensualsubjects--for commercially motivated trials whose findings are predeterminedor manipulated to come to a predetermined conclusion.These revelations call for a thorough independent examination of the entirebody of Dr. Biederman's publications--as there is reason to suspect they mayhave seriously corrupted the psychiatric literature, such as it is.See: Biederman Deposition Transcript: Feb 26:http://www.windhover.com/pdf/biedermanday1.pdf and Feb 27:http://www.windhover.com/pdf/biedermanday2.pdfSee also, Ed Silvermanhttp://invivoblog.blogspot.com/2009/03/harvards-biederman-after-me-there-is.htmlContact: Vera Hassner Sharavveracare212-595-8974http://www.nytimes.com/2009/03/20/us/20psych.htmlTHE NEW YORK TIMESMarch 20, 2009Drug Maker Told Studies Would Aid It, Papers SayBy GARDINER HARRISAn influential Harvard child psychiatrist told the drug giant Johnson & Johnson that planned studies of its medicines in children would yieldresults benefiting the company, according to court documents dating overseveral years that the psychiatrist wants sealed.The psychiatrist, Dr. Joseph Biederman, outlined plans to test Johnson & Johnson's drugs in presentations to company executives. One slide referredto a proposed trial in preschool children of risperidone, an antipsychoticdrug made by the drug company. The trial, the slide stated, "will supportthe safety and effectiveness of risperidone in this age group."Dr. Biederman was the lead author of a trial published last year concludingthat treatment with risperidone improved symptoms of attention deficit andhyperactivity disorder in bipolar children.Dr. Biederman - who was director of the Johnson & Johnson Center forPediatric Psychopathology Research at Massachusetts General Hospital, inBoston - is in the middle of two controversies: one involves the use ofantipsychotic drugs in children, and the other relates to conflicts ofinterest in medicine.He is the world's most prominent advocate of diagnosing bipolar disorder ineven the youngest children and of using antipsychotic medicines to treat thedisease, but much of his work has been underwritten by drug makers for whomhe privately consults. An inquiry by Senator Charles E. Grassley, Republicanof Iowa, revealed last year that Dr. Biederman earned at least $1.6 millionin consulting fees from drug makers from 2000 to 2007 but failed to reportall but about $200,000 of this income to university officials.Harvard and the National Institutes of Health are investigating whether Dr.Biederman violated federal and university research rules. He has suspendedhis work with the drug industry during the investigations.Dr. Biederman has become a key witness in a series of lawsuits filed bystate attorneys general claiming that makers of antipsychotic drugsdefrauded state Medicaid programs by improperly marketing their medicines.His work helped fuel a rapid rise in the use of these medicines in children.In November, the lawyers for the states released e-mail messages andinternal documents from Johnson & Johnson that showed the company hadintended to use its connection with Dr. Biederman to increase sales. Thedocuments became public in a motion filed by plaintiffs' lawyers to compelhim to be interviewed.Dr. Biederman has not responded to messages seeking comment. An article inThe Boston Globe in December quoted a letter to the newspaper in which hewrote that while Johnson & Johnson had sought commercial applications to hiswork, "any implication that J. & J.'s interests interfered with the center'swork is wrong."A spokeswoman for Massachusetts General Hospital said Thursday that shecould not comment on pending litigation.Judge Jamie D. Happas of New Jersey Superior Court, who is overseeing themultistate litigation, ruled last year that Dr. Biederman should be deposed.As part of that process, Dr. Biederman provided lawyers with documentsrelating to his interactions with Johnson & Johnson; the documents includedpresentations he made over several years summarizing the work of the center,financed by the company.Peter Spivack, a lawyer representing Dr. Biederman, filed a motion seekingto keep these documents under seal. The New York Times received copies ofthe documents.In a letter filed with the court on Thursday, Mr. Spivack said articles inThe Times about Dr. Biederman had "publicly embarrassed Dr. Biederman and,in part, led to an agreement to forestall contact with pharmaceuticalcompanies."One set of slides in the documents referred to "Key Projects for 2004" andlisted a planned trial to compare Risperdal, also known as risperidone, withcompetitors in managing pediatric bipolar disorder. The trial "will clarifythe competitive advantages of risperidone vs. other neuroleptics," the slidestated. All of the slides were prepared by Dr. Biederman, according to hissworn statement.In 2005, Dr. Biederman was the lead author of a study comparing Risperdaland Zyprexa, made by Eli Lilly. The study concluded that Risperdal improvedsubjects' depressive symptoms but that Zyprexa did not.A slide listing "Key Projects for 2005" mentioned a planned study inadolescents of Concerta, a stimulant manufactured by Johnson & Johnson. Thestudy will "extend to adolescents positive findings with Concerta inA.D.H.D. N.O.S. in adults," the slide said, referring to unusual cases ofattention deficit hyperactivity disorder.In 2006, Dr. Biederman was co-author of a study showing that children givenConcerta for a prolonged period did not have reduced growth, allaying asignificant concern about the medicine.Josephine Johnston, a research scholar at the Hastings Center, a bioethicsresearch institute, said the documents "raise questions about howwell-designed Dr. Biederman's trials were in that he promised a result tohis funders."  "It's another shadow over his work," Ms. Johnston said.In a contentious Feb. 26 deposition between Dr. Biederman and lawyers forthe states, he was asked what rank he held at Harvard. "Full professor," heanswered."What's after that?" asked a lawyer, Fletch Trammell."God," Dr. Biederman responded."Did you say God?" Mr. Trammell asked."Yeah," Dr. Biederman said.FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit.  =====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.