(Formerly National Depressive and Manic-Depressive Association – NDMDA)
The NDMDA was one of the major front groups established in 1986 that could lobby Congress for further research funds and mental health budgets. They were formed shortly after psychiatrist Herbert Pardes left the National Institute of Mental Health (NIMH) as director and was an advisor to NDMDA (since 2002 called the Depression and Bipolar Support Alliance, DBSA). By 1999, at least 7 NIMH psychiatrists were on its advisory board, including Charles Nemeroff who was Chairman of the Board of Directors Executive Committee (whose conflicts of interest with the pharmaceutical industry recently came under Senate Finance Committee investigation). During the decade following the establishment of NDMDA (and similar groups), federal funds to the NIMH budget increased 233%—from a total of $1.7 billion between 1978 and 1986 to more than $5.6 billion in the decade following. Since 1987 the NIMH budget has increased nearly 1,000%—in 2008 reported at almost $19 billion.[1]
The pharmaceutical industry now admits that investing in “advocacy groups” is an efficient tool for driving long-term support of drug brands—perhaps even more effective than direct-to-consumer marketing.[2] The advisory board of DBSA shows why.
Psychiatrist Jan A. Fawcett, M.D. helped found NDMDA and has been on its Scientific Advisory Council since then, while also conducting a 19-year study on depression for NIMH. Like many of the DBSA advisory board members, Fawcett is connected to other pharmaceutical company funded front groups, including the National Alliance for Research on Schizophrenia and Depression (NARSAD)[3] and he has been president of the American Suicide Foundation (now American Foundation for Suicide Prevention).[4] He is with the Department of Psychiatry of the University of New Mexico School of Medicine, and is Chair of the Mood Disorders Work Group of the DSM-V (Diagnostic & Statistical Manual of Mental Disorders) Task Force—a task force whose members have come under scrutiny for their financial ties to drug companies.[5]
His financial disclosure includes: Abbott Laboratories, Alphapharm, Eli Lilly, Wyeth, Merck (Merck Manual, and has a commercial relationship with the company) and has been an expert witness in cases involving pharmaceutical companies.[6]
- The group received $37,510 from Lilly in 2007 and $20,000 in 2008.[7]
- DBSA’s 2007 Annual Report shows it received between $150,000 and $499,000 from AstraZeneca, Pfizer, and Wyeth. Abbott, Cyberonics, Lilly, Forest, Glaxo, Organon, and Otsuka American Pharmaceuticals gave between $10,000 and $149,999.[8]
- The report also notes that a “First-ever DBSA Hope Award” for lifetime achievement was presented to Frederick Goodwin, former NIMH Director (1981-88) and also under Senate investigation for undisclosed pharmaceutical company funding.[9]
- Its websites provides a list of medications and drug companies to contact for medication information, while its 2009 conference was supported by Eli Lilly and AstraZeneca’s disease-mongering exhibit, “The Bipolar Journey.”[10]
The DBSA describes itself as “the leading patient-directed national organization” but its 67-member scientific “advisory” board defies this.[11]
A cursory review of the board finds only a handful of members without conflicts of interest. In a brief overview, the following shows the DSBA’s incestuous relationship between government agencies like NIMH and the FDA, the APA, and the pharmaceutical companies making psychotropic drugs or devices such as the electrode brain implantation to supposedly treat “depression.”
- The board includes seven psychiatrists under Senate Finance Committee investigation over their conflicts of interest with the pharmaceutical company, failing to declare nearly $11.7 million between them to universities and agencies with whom they worked and required such disclosure.[12] These are Joseph Biederman, Frederick Goodwin, Martin Keller, Charles B. Nemeroff, A. John Rush, Alan F. Schatzberg and Karen Wagner.[13]
- At least four members were on the DSM-IV Review Panels—exposed in 2006 for its members’ undisclosed ties to the pharmaceutical industry. 100% of the members of the task forces deciding upon which “bipolar” disorders, depression, and psychosis disorders should be included in the DSM-IV had received drug company funding. Another DBSA member co-wrote an entire chapter (43) of DSM-IV. At least four of the DBSA advisory board members sit on the DSM-V Review, including David Kupfer, its chair.
- At least a dozen of the board members are former NIMH officials or sat on NIMH Committees. Other board members have been affiliated with other government agencies, often in research, including: Veteran Affairs, US Army, Dept. of Defense, US Public Health Service and the FDA psychopharmaceutical advisory committees. Dr. Edward Scolnick served as a member of the FDA Science Board from 2000 to 2002, while Dr. Robert Post is currently chief of the Biological Psychiatry Branch of NIMH.
- In addition to pharmaceutical company funding, at least 26 of the Board members have received research funds from NIMH, making theirs and the former NIMH staffs’ affiliation with DBSA a very cozy relationship. Lauren B. Marangell, M.D. is co-director of the NIMH Bipolar Trials Network.
- At least three of the board members are former or current employees of pharmaceutical companies: Dr. Lauren B. Marangell is a “Distinguished Lilly Scholar” at Eli Lilly. Keh-Ming Lin, M.D., MPH, has prior employment with Zeneca Pharmaceuticals.[14] From 1982 to 2003, Edward Scolnick served in a number of key leadership roles at Merck Research Laboratories, is its president emeritus and was chief scientist during the Vioxx scandal (anti-inflammatory drug withdrawn from the market because it caused heart attacks—which Merck was aware of but did not publicly disclose).[15]
- Four of the DBSA advisors were authors of the controversial GlaxoSmithKline (GSK) study 329 that covered up adverse effects of the drug on children: Neal Ryan, Barbara Geller, Martin Keller and Karen Wagner (the latter two investigated by the Senate Finance Committee for undisclosed pharmaceutical company funding). Children suffered serious adverse reactions, including self-harm—mostly cutting; aggression—violent to others; and suicidal thoughts and actions and suicide attempts. Almost 8% of the children had to be hospitalized as a result.[16] Not one of the authors who lent their names to this study have come forth to explain their deception.[17] Study 329 was cited in a New York case where GSK was charged with “repeated and persistent fraud” in suppressing research on paroxetine (Paxil) that had shown increased risk of suicidal thoughts and actions in children taking it. On June 3, 2004 GSK paid $2.5 million to settle the lawsuit.[18]
- Another member, David Dunner, of the University of Washington’s Department of Psychiatry admitted he “ghostwrote” an article about Paxil that appeared in the March 1995 issue of the journal European Neuropsychopharmacology on behalf of GSK and concluded that the antidepressant was less likely to lead to suicidal thoughts than the older antidepressant imipramine or a placebo (sugar pill). However, Dunner had never looked at any of the data yet was still listed as an “author” of the article.
- At least 9 DBSA advisory board members have stock or equity in or helped found pharmaceutical drug or device/development companies, including Alan Schatzberg (founded and has stocks/equity in Corcept Therapeutics,“ an emerging pharmaceutical company.”) Corcept’s scientific advisors include DBSA advisors: Doctors Alan Schatzberg, Ned H. Kalin (stockholder), and Ranga R. Krishnan. Other DBSA advisory board members that list Corcept in their financial disclosures include: doctors Pedro L. Delgado, Charles Nemeroff (stockholder), David Rubinow (stockholder), and David J. Kupfer, Chair of the DSM-V Task Force.
- More than 10 of the DBSA advisory members are affiliated with Cyberonics, a medical device company that patented VNS (Vegas Nerve Stimulation), a “Clock Work Orange” procedure (costing $15,000- $25,000) and involving implanting electrodes in the brain that send electrical pulses through the brain to “treat” depression. Of these members, at least 3 psychiatrists are steeped in controversy over a study of VNS and its publication in Neuropsychopharmacology when they failed to disclose their financial ties to Cyberonics: A. John Rush, Dennis Charney and Charles Nemeroff. Nemeroff resigned as editor of the journal after he published the paper without disclosing that eight of nine authors–including himself–had financial ties to Cyberonics. Cyberonics also published data in Biological Psychiatry, the editor of which is Charney.[19] In 2006, NAMI—which also has Charney as an advisor—became a corporate partner with Cyberonics, which gave it $75,000 for its “Campaign for the Mind of America.”[20]
- Charney holds a patent in the drug ketamine.[21] On its website DBSA makes a point of claiming that neither it or its advisors and consultants “endorse or recommend the use of any specific treatment or medication,” but then advertises for readers to participate in a clinical drug trial of ketamine.[22]
- At least 6 of the DBSA advisors were researchers and co-authors of the American College of Neuropsychopharmacology (ACNP)-funded study published in January 2004 that found that SSRI antidepressants did not increase the risk of suicide in children and adolescents. ANCP is an organization of psychiatrists with significant financial support from the manufacturers of psychotropic drugs. The authors included: doctors Jan Fawcett (founder of DBSA), Frederick Goodwin, Karen Wagner (Paxil study 329 above), Neal Ryan (Paxil study 329), David Shaffer (invented “TeenScreen” to identify and label teens as depressed) and J. John Mann. Their findings were in stark contrast to the 2003 UK drug regulatory agency warning that there was a serious risk that antidepressants could cause suicide in those younger than 18 (as the FDA confirmed in October 2004 with a black box warning).[23] Mann, Co-Chair of an ACNP Task Force, painted an alarmingly inaccurate picture, stating: “The evidence linking SSRIs to suicide is weak.” Added Mann, “…SSRIs do not cause suicide in youth with depression.” [24] Mann has been a consultant for two of the biggest antidepressant makers: GSK and Pfizer and is also an advisor to Eli Lilly and Lundbeck.[25] Mann has also been a defense expert witness for Pfizer and GSK in litigation related to SSRIs. He is consistently relied upon by the companies as a spokesperson to counter the claims that SSRIs cause suicide.[26]
- Two of the advisors helped developed the Texas Medication Algorithm Project (TMAP) psychiatric drug program invented by drug companies for Texas to force doctors to prescribe the most expensive psychotropic drugs: A. John Rush and Karen Wagner. Another member, Trisha Suppes, M.D., Ph.D, was Director of the Bipolar Disorder Module for the Texas Implementation of Medication Algorithms (TIMA)—considered “Phase 4” of TMAP. “The roll-out of TIMA has begun with the training of physicians and support personnel in algorithm implementation,” the TIMA manual for physicians states.[27]
- About 6 of the DBSA advisory members helped develop the so-called “Mood Disorder Questionnaire” in 2000 to screen people for “bipolar” or “mood disorders.” These include: Robert M.A. Hirschfeld, Joseph R. Calabrese, Paul E. Keck, Robert M. Post, Gary S. Sachs (a principle investigator in NIMH bipolar research), and John M. Zajecka, along with Lydia Lewis, former president of DBSA, and Laurie Flynn, head of NAMI (now over Columbia University’s TeenScreen). The subjective questionnaire could land anyone with a bipolar label with such questions as: Has there ever been a period of time when you were not your usual self and you were so irritable that you shouted at people or started fights or arguments? You felt much more self-confident than usual? You got much less sleep than usual and found you didn’t really miss it?[28]
- Columbia University’s Dr. David Shaffer, who invented the TeenScreen questionnaire now being foisted off on teenagers to label them as depressed (to get them on antidepressants) is also on the advisory board of DBSA.
- Add to this the fact that the advisory board members cross over to other pharmaceutical company funded groups, including at least 6 affiliated with or having been awarded by NAMI; more than a dozen are recipients of NARSAD awards, research funds or are on its scientific advisory board, and at least 11 are on the advisory board of or have been awarded by the American Foundation for Suicide Prevention—all groups that rely substantially on drug company funding.
Government agencies such as NIMH, FDA and NIH should not have its officers or employee researchers sitting on the Boards or as advisors to groups such as DBSA.
[1] “National Institute of Mental Health: Appropriations: Grants and Direct Operations,” NIH 1999 Almanac, National Institutes of Health, U.S. Dept. of Health & Human Services — NIMH Funding: 1978-1986 $1,764,300,000 and 1987 – 1997 $5,699,210,000; “National Institute of Mental Health: Appropriations: Grants and Direct Operations,” NIH 2008 Almanac, National Institutes of Health, U.S. Dept. of Health & Human Services — 1987-2008 $18,988,401,000.
[2] Josh Weinstein, “Public Relations: Why Advocacy Beats DTC,” Pharmaceutical Executive, 1 Oct. 2009. http://pharmexec.findpharma.com/pharmexec/article/articleDetail.jsp?id=129300&sk=&date=&pageID=1.
[3] http://search.barnesandnoble.com/New-Hope-for-People-with-Bipolar-Disorder/Jan-Fawcett/e/9780761530084; http://www.narsad.org/?q=node/18/aboutus.
[4] http://www.wpic.pitt.edu/STANLEY/2ndbipconf/default.htm.
[5] http://www.psych.org/MainMenu/Research/DSMIV/DSMV/MeettheTaskForce/JanFawcettMD.aspx.
[6] http://www.psychconflicts.org/pdfs/APA_Program_2007.pdf; http://www.psych.org/MainMenu/Research/DSMIV/DSMV/MeettheTaskForce/JanFawcettMD.aspx.
[7] http://dissidentvoice.org/2009/04/just-say-no-to-the-mothers-act/.
[8] http://dissidentvoice.org/2009/04/just-say-no-to-the-mothers-act/.
[9] http://dissidentvoice.org/2009/04/just-say-no-to-the-mothers-act/.
[10] http://www.dbsalliance.org/site/PageServer?pagename=events_09confexhibits.
[11] http://www.dbsalliance.org/site/PageServer?pagename=dbsa_aboutdbsa.
[12] http://www.dbsalliance.org/site/PageServer?pagename=dbsa_scienceboard; http://www.pharmalot.com/2008/11/harvards-biederman-and-his-ties-to-jj/; http://www.nytimes.com/2008/11/22/health/22radio.html; http://www.pharmalot.com/2008/07/grassley-targets-browns-keller-over-grants/; http://www.nytimes.com/2008/10/04/health/policy/04drug.html?_r=2&hp=&adxnnl=1&oref=slogin&adxnnlx=1223057208-yLGUJtDvWYfbOCZN1tb1pA; http://www.pharmalot.com/2008/10/emorys-nervous-nemeroff-reacts-to-a-probe/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Pharmalot+%28Pharmalot%29; http://www.usnews.com/articles/news/national/2008/06/26/committee-questions-a-top-psychiatrist.html.
[13] http://www.dbsalliance.org/site/PageServer?pagename=dbsa_scienceboard.
[14] http://www.psychsearch.net/apaips1998.pdf.
[15] http://www.redorbit.com/news/health/1251681/alnylam_appoints_dr_edward_scolnick_to_board_of_directors_and/index.html; http://www.nami.org/Template.cfm?Section=Press_Release_Archive.
[16] http://seroxatsecrets.wordpress.com/2008/03/06/this-is-how-glaxo-hid-data-and-fooled-the-regulators/.
[17] Evelyn Pringle, “Another shrink bites the dust,” Lawyers and Settlement.com, 9 Apr. 2009. http://www.lawyersandsettlements.com/blog/another-shrink-bites-the-dust-08.html.
[18] David B. Caruso, “GlaxoSmithKline begins releasing data on drug trials,” Associated Press, 2 Sept. 2004; The People of the State of New York, by Eliot Spitzer, Attorney General of the State of New York vs. GlaxoSmithKline.
[19] http://www.nytimes.com/2006/07/25/health/25news.html.
[20] http://www.nytimes.com/2006/07/25/health/25news.html;
http://74.125.95.132/search?q=cache:DbSaHTEJUb0J:www.nami.org/Content/NavigationMenu/Inform_Yourself/About_NAMI/Governance/Strategic_Planning/StratPlanConsolidatedJUN06_FINAL.doc+nami+cyberonics&cd=9&hl=en&ct=clnk&gl=us.
[21] http://books.google.com/books?id=T_FP2QvGZ1MC&pg=PR12&lpg=PR12&dq=dENNIS+cHARNEY+cyberonics&source=bl&ots=lp_dJdhGDv&sig=3g-dEqC62YuNvWOIfYkgePL3klk&hl=en&ei=9YsQS8ucNsv9nAfx0-DJAw&sa=X&oi=book_result&ct=result&resnum=2&ved=0CAsQ6AEwAQ#v=onepage&q=dENNIS%20cHARNEY%20cyberonics&f=false.
[22] http://www.dbsalliance.org/site/PageServer?pagename=research_trials_bipolarlist.
[23] http://www.ahrp.org/infomail/04/01/21.php.
[24] http://www.ahrp.org/infomail/04/01/21.php.
[25] http://archpsyc.ama-assn.org/cgi/content/full/64/8/914?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=szanto&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT.
[26] http://www.baumhedlundlaw.com/media/ssri/paxil/FDAHearing/FDA.htm.
[27] http://www3.interscience.wiley.com/journal/118809088/abstract?CRETRY=1&SRETRY=0. http://www.dshs.state.tx.us/mhprograms/pdf/timaMDDman.pdf.