ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability  http://www.ahrp.org and http://ahrp.blogspot.com FYI To appreciate the culture of corruption that undermines medical institutions that fail to protect the integrity of medical research from the undue influence of industry, see the statement (below) issued by Dr. Peter L. Slavin, Mass General president, and Dr. David F. Torchiana, head of Mass General Physicians Organization, in support of Dr. Joseph Biederman and his two colleagues, Drs. Timothy Wilens, and Thomas Spencer whom the statement describes as pioneers in the field of child mental health. These prominent child psychiatrists have been caught lying about $4.2 million they received from pharmaceutical companies whose drugs they have aggressively promoted for use in children, and their conduct has sullied the reputation of Harvard University and its hospital affiliate, Massachusetts General. The adulatory statement published in the Boston Globe describes the three as beloved and trusted by thousands of grateful children and families who have counted on them for treatment, counseling, help and hope. We know this is an incredibly painful time for these doctors and their families, and our hearts go out to them. http://www.boston.com/news/health/blog/2008/06/post_8.html One can only speculate whether Mass General will continue to rally round Dr. Biederman and the other so-called pioneers who failed to disclose their considerable pharmaceutical income should the National Institute of Health revoke its grants to the institution as a consequence of their violation of federal conflict of interest rules. To appreciate the magnitude of pharmaceutical influence on American psychiatry, one needs to look at the documented evidence showing that psychiatrys diagnostic manual the DSM-IVwhich determines the criteria for issuing diagnosesand psychiatrys pre_script_ion guidelines (e.g., TMAP) have been formulated by industry-funded psychiatrists whose integrity is a matter of debate.  Recent investigations revealed over 50% of authors revising the Diagnostic and Statistical Manual of Mental Disorders (DSM) had financial ties to the pharmaceutical industry.Within the Mood Disorders and Schizophrenia and Other Psychotic Disorders; panel, 100% of members had financial ties. See: Oregon DUR Board Newsletter, Feb. 2007 http://pharmacy.oregonstate.edu/drug_policy/pages/dur_board/newslette... les/volume9/DURV9I1.pdf And one needs to examine the unabashed promotional hype that has been passed off as research by the foremost company-financed child psychiatristswhose influence has succeeded in popularizing a previously unaccepted diagnosis in childrenBipolar (a.k.a. Manic Depression) a rare condition in adults. It is instructive to review the following: 1. The website describing the Pediatric Psychopharmacology Program at Harvard-affiliate, Massachusetts General Hospital: Founded just twenty-five years ago, the Pediatric Psychopharmacology Program is the largest research program in the Department of Psychiatry, and its researchers are among the most prolific and respected child psychiatrists and psychologists in the world. Under the leadership of renowned child psychiatrist and founder, Joseph Biederman, MD, the program has changed the face of child psychiatry http://www.massgeneral.org/children/research/researchers/biederman.aspx#   2.  A bevy of supportive letters to The New York Times from organizations that have considerable vested interests in promoting pediatric Bipolar Disorder which is hugely profitable for their pharmaceutical company benefactors. See: letters from the American Medical Association and the Association of American Universities; the American Psychiatric Association, the Child and Adolescent Bipolar Foundation, and the Pediatric and Adolescent Advisory Council at Massachusetts General Hospital. Though the spokespersons for these organizations espouse support for disclosure, they all fail to mention their organizations own substantial pharmaceutical financial ties. An unpublished letter to the Times by Dr. Nathaniel Lehrman follows below. 3. Honesty in medical education is hard to come by. So, Dr. Daniel Carlat a psychiatrist who is not  on the take,  who publishes both the Carlat Psychiatry Report,  a peer-reviewed, non-industry biased, CME publication, and the Carlat Blog,  is trustworthy. In the Carlat  Blog, Dr. Carlat expresses his (admittedly)  very biased opinion, formed as a result of participating in many CME activities, that allowing pharmaceutical companies to sponsor accredited medical education leads to many bad things, including biased education, corrupt physicians, and, ultimately, harm to our patients. So, if you are interested in the tangled politics and economics of CME, read on http://carlatpsychiatry.blogspot.com/2007/06/biederman-bashing-sure-i... but.html   [The Carlat Report is at: http://www.thecarlatreport.com/ Contact: Vera Hassner Sharav This e-mail address is being protected from spam bots, you need JavaScript enabled to view it 212-595-8974 http://www.boston.com/news/health/blog/2008/06/post_8.html BOSTON GLOBE Psychiatrists under fire supported by Mass. General by Elizabeth Cooney June 11, 2008 Three Harvard psychiatrists facing a US Senate inquiry got a vote of confidence from their hospital as beloved and trusted by thousands of grateful children and families. Senator Charles Grassley is looking into the doctors' failure to report payments of more than a million dollars in consulting fees from drug makers from 2000 to 2007. A memo from top officials at Massachusetts General Hospital obtained by the Globe praised Drs. Joseph Biederman, Timothy Wilens, and Thomas Spencer as pioneers in the field of child mental health while also endorsing closely managed collaboration with industry and promising a review of conflict-of-interest policies. They are beloved and trusted by thousands of grateful children and families who have counted on them for treatment, counseling, help and hope. We know this is an incredibly painful time for these doctors and their families, and our hearts go out to them, Dr. Peter L. Slavin, hospital president, and Dr. David F. Torchiana, head of Massachusetts General Physicians Organization, write. The three psychiatrists received money from companies that made the medications they researched and recommended. Biederman's work is widely _link_ed to a steep rise in bipolar diagnoses among children. On Sunday Biederman told the New York Times my interests are solely in the advancement of medical treatment through rigorous and _object_ive study. The full Mass. General memo follows: As you may know, the Sunday New York Times contained a page 1 article regarding ongoing inquiries of the US Senate Finance Committee, led by Sen. Charles Grassley of Iowa, focusing on relationships between drug companies and physicians and academic institutions. This story, which was picked up by the Boston Globe and other media outlets, described Sen. Grassleys inquiries into the financial disclosures of three MGH psychiatrists, Joseph Biederman, MD, Timothy Wilens, MD, and Tom Spencer, MD, all pioneers in the field of child mental health. During this process, the committee raised a number of questions about our institutional policies for interactions with industry and about the information provided by the physicians about the payments they received from certain pharmaceutical companies. We wanted you to be aware of a number of issues related to this situation. First, we want to state that MGH firmly believes that appropriate and closely managed collaborations between academia and industry are important in the ongoing quest to discover treatments, cures and preventions for diseases that afflict millions of people worldwide. The innovative work of scientists at institutions like the MGH provides the intellectual and scientific foundation for so many of the therapies that industry has developed, tested, manufactured and carried to the marketplace to benefit patients. Second, we want to emphasize that the three MGH physicians being reviewed have all been vital p_layer_s in such productive collaborations with industry. Their impressive body of academic work, backed up by significant data and rigorous science, has earned them reputations as international leaders in the understanding and treatment of serious pediatric psychiatric disorders. Perhaps most important, they are beloved and trusted by thousands of grateful children and families who have counted on them for treatment, counseling, help and hope. We know this is an incredibly painful time for these doctors and their families, and our hearts go out to them. You also should know that MGH has cooperated fully with Sen. Grassley. We have provided the disclosure forms requested as well as information about our conflict-of-interest processes and systems for disclosing relationships with and income from industry. As a recipient of significant public research funds, the MGH embraces its obligation to not only uphold science that is rigorous and sound, but also to conduct research according to the highest ethical standards and in compliance with rules and regulations designed to ensure quality, _object_ivity and accuracy. Finally, we want you to know that the MGH takes Senator Grassleys concerns regarding financial disclosures very seriously and has undertaken a thorough internal review of all the issues raised by him. Harvard Medical School is likewise doing the same with respect to compliance with its policies. In addition, the MGH is participating in a senior administrative commission initiated by Partners HealthCare that aims to re-examine all of our policies relating to our interactions with industry to ensure that they appropriately address all issues in the relationships between Partners institutions and its physicians and industry. Our ultimate hope is that after such a comprehensive review, our processes will be further enhanced, strengthened and streamlined. We will no doubt learn a great deal from this experience  as difficult as it may be  and we must be willing to share the insights and perspectives we gain to improve conflict-of-interest processes not just here, but at academic institutions nationwide. Peter L. Slavin, MD, President, MGH David F. Torchiana, MD, Chairman and CEO, MGPO Comments so far... 1.      The drugging of children for profit. Did they promote this agenda to help children, or line their pockets. There are very strict disclosure rules on this type of thing. Posted by Kevin June 11, 08 05:25 PM 2.      This sounds quite a bit like the 50's when MD's at MassMental fed disabled children oatmeal laced with radioactive isotopes - never bothering to disclose the nature of the research being conducted to the families. American medicine today is simply the user interface of the Insurance-Pharma-Industrial Complex. These healers prove the rule rather than the exception. Corporate platitudes and goobleygook from other MDs written by PR flacks in their employ ring hollow indeed. Posted by terrence mckenna June 11, 08 06:05 PM 3.      For so highly regarded an institution, MGH has released a statement not unlike those disseminated by college football coaches after a star halfback gets caught cheating on his exams. The physicians charged with inappropriate behavior related to money big enough to pay for swanky places on the Cape are beloved and trusted. Being fingered for failing to comply with requirements to report exceptionally lucrative arrangements has created an incredibly painful time for these doctors and their families, and our hearts go out to them. The accused are vital p_layer_s and international leaders. Given the tone of this statement, I think that that I can predict the outcome of the thorough internal review of all the issues raised. Rather than being fired for embarrassing the institution for what what may be kindly called inappropriate behavior, my hunch is that these guys will stay in the starting MGH lineup. Just as in big-time college football, there is too much money at stake for an honest consideration of ethics and integrity. Appropriate consequences are for those that don't play the game seriously. To adapt the haec olim meminisse iuvabit passage from the Aeneid to this circumstance: Some day they will look back upon this time and laugh about it over gin and tonics on the Cape. Posted by octoberjazz June 11, 08 07:12 PM ~~~~~~~~~~~~~~ THE NEW YORK TIMES June 16, 2008 Letters Doctors, Research and Drug Payments Re Researchers Fail to Reveal Full Drug Pay (front page, June 8) and Hidden Drug Payments at Harvard (editorial, June 10): The first obligations of those who conduct lifesaving research at American medical schools, teaching hospitals and research universities are to protect the safety of patients and assure the integrity and _object_ivity of science. Researchers and their institutions must reveal to research participants potential financial conflicts of interest and comply with reporting requirements. Our associations recent report, Protecting Patients, Preserving Integrity, Advancing Health, urges our medical schools and research universities to require clinical research faculty to report all outside income directly or indirectly related to professional responsibilities. The report also strongly urges our institutions to develop and carry out rigorous oversight policies for institutional conflicts of interest. The public must be assured that scientific results are honest and that patient safety is not compromised for financial gain. We are committed to these principles and hope to work with Senators Charles E. Grassley and Herb Kohl in their legislative effort. Robert M. Berdahl Darrell G. Kirch Washington, June 11, 2008 The writers are presidents of, respectively, the Association of American Universities and the Association of American Medical Colleges. The public deserves to have access to information about relationships between medicine and the pharmaceutical industry (Hidden Drug Payments at Harvard, editorial, June 10), just as the public should be aware of relationships between legislators and lobbyists. Once we know about relationships, we can consider whether any potential conflicts they pose affect our own interests. These relationships can have positive outcomes. Financing for much of the research that has allowed rapid advances in diagnosing and treating illnesses comes from the same pharmaceutical companies and device makers that profit when the research is successful. Often medical schools depend on income from this industry-backed research to educate the next generation of physicians. The American Psychiatric Association supports and encourages the full disclosure of relationships between physicians and pharmaceutical companies and any other possible sources of conflicts of interest. Transparency helps to protect medical education, research and care. But for real solutions, we have to look even further to ourselves and to our government to pay for the kind of medical education and research that has for decades provided new and better treatments for medical conditions. Nada Stotland Chicago, June 11, 2008 The writer, a medical doctor, is president of the American Psychiatric Association. * While it is good news that there is a bill introduced in the Senate that would require drug and device makers to disclose payments to doctors that exceed $500 annually, such disclosure should also be easily accessible to parents and other consumers. In New York, a parents informed consent is required before a doctor can administer nonemergency psychotropic drugs to a child. In order to make a fully informed choice, parents must be aware of all the relevant information, which should include a doctors potential conflict of interest. Lawyers are bound to disclose potential conflicts of interest because they may compromise the lawyers professional integrity. Doctors should be held to the same standard, especially where the lives of children are at stake. Diane Goldstein Temkin New York, June 10, 2008 The writer is a lawyer with the Mental Hygiene Legal Service, a state agency that protects the rights of the mentally disabled. * The Child and Adolescent Bipolar Foundation supports full disclosure of pharmaceutical company payments to physicians and researchers. Parents and doctors need all the information to evaluate research on treatments, including information about potential conflicts. Families living with pediatric bipolar disorder face challenges few others can imagine. Their children may be suicidal or explosive and unable to function in school or at home. Early treatment saves lives and improves the long-term prognosis, but diagnosis typically trails onset by a decade. We cannot allow controversy or confusion to further harm children yet undiagnosed. Complex psychiatric conditions like pediatric bipolar disorder require more well-designed, large-scale and long-term studies. These studies should be federally financed, so researchers will be less reliant on pharmaceutical financing. Susan Resko Exec. Dir., Child and Adolescent Bipolar Foundation Wilmette, Ill., June 8, 2008 * June 17, 2008 I am writing as the parent of a child who suffered from early-onset rapid cycling Bipolar II as well as many other illnesses. It is astounding to me the kind of outrageous attacks Senator Charles E. Grassley has maintained against Dr. Joseph Biederman in particular and pediatric psychiatric research in general. There is no one more dedicated or concerned for the vast numbers of children suffering from these devastating illnesses than Dr. Biederman and the extraordinary group of doctors he has assembled into a world-famous team to try to save them. If these doctors were looking to make fortunes, they would not be in research; perhaps they would not be treating these most difficult cases, which demand their attention 24 hours a day. Perhaps it would serve the taxpayers better if their hard-earned dollars were spent delving into the huge amounts of corporate greed and lack of accountability rather than constantly attacking these courageous pioneers. We should be paying special homage to this group of incredibly dedicated, brilliant and caring doctors who make even the most fleeting stability possible for children who suffer from unfathomable demons and terrors. It is all too easy to accuse in this country. And after reputations are dirtied, no matter how innocent one is, who is there to shout out for innocence and excellence? Lynn Tesher New York, June 8, 2008 The writer is on the Pediatric and Adolescent Advisory Council at Massachusetts General Hospital Copyright 2008 The New York Times Company To the Editor: The forty-fold increase between 1994 and 2003 in children diagnosed with bipolar disorder  (news story, June 8, but not mentioned by June 16s four official letters to the editor) is at least as important as the hidden drug payments to psychiatrists involved in this epidemic.  The increase results from psychiatrists labeling children and then drugging them, rather than helping parents teach youngsters self-control through appropriate limits on temper tantrums and other mood-swings  as mental health professionals did routinely before biological psych,iatry took over the specialty. Such excessive swings are part of almost everyones growing up.   Parents have controlled them from time immemorial by setting firm, warm, consistent limits. But when parental authority is undermined  when the swings scare the parents, or the latter are divided on how to handle them - the cycles may continue and even worsen. Calling such mood-swings bipolar disorder aggravates them further by defining them as illnesses beyond the capacity of either child or parents to control.  This undermines  parental authority still more. And  when physician-prescribed drugs are relied on to control such swings, the swings can become the focus of a familys entire life  with results  that can be catastro,phic. When will todays biopsychiatrists recognize that substituting drugs for competent child-rearing  creates tragedies like that of Rebecca Riley?  She died at age 4 after being started at 28 months (also called the Terrible Twos) because of  bipolar disorder on powerful  prescribed medications (unapproved for children) by a university psychiatrist, who pre,scribed similarly for her two older siblings.   Nathaniel S. Lehrman, M.D., 10 Nob Hill Gate, Roslyn NY  11576; 516/626-0238. Former Clinical Director, Kingsboro Psychiatric Center NY; former Assistant Clinical Professor of Psychiatry, Albert Einstein and SUNY Downstate College of Medicine. FAIR USE NOTICE: This may contain copyrighted () ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' 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 without profit. _______________________________________________ Infomail1 mailing list to unsubscribe send a message to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it