Urgent Letter of Protest to Federal Mental Health Agency from EdWatch
and a Coalition of Groups

December 12, 2005
 
Mr. Charles Curie
Office of the Administrator
Substance Abuse and Mental Health Services Administration
1 Choke Cherry Road 
Room 8-1036
Rockville, MD 20857
 
Dear Mr. Curie,
 
This letter is a follow-up to the October 17th, 2005 meeting organized by Michael Ostrolenk between you, members of your staff, and representatives of the Alliance for Human Research Protection, EdWatch, Eagle Forum, The International Center for the Study of Psychiatry and Psychology, MindFreedom International, The Association of American Physicians and Surgeons, and the American Psychoanalytic Association.
 
We appreciate the opportunity to share our concerns about the New Freedom Commission (NFC) report and Federal Mental Health Action Agenda (FMHAA). It is important that you hear from groups and individuals that have been critical of these documents and the programs that they represent.  We also appreciate the clarification of the role of and the increased emphasis on parental consent, as well as your willingness to make sure that consent is truly active and informed, and that the requests for grant applications emphasize parental consent.
 
We are, however, very distressed at what appears to us to be a significant discrepancy between your statements and the reality of SAMHSAs role in implementing the NFC report recommendations, as well as other discrepancies between your statements and SAMHSAs actions.
 
For example, you stated, "The New Freedom Commission report is not official Bush Administration policy, but rather the unofficial recommendations of an appointed commission."  You also stated that the state incentive transformation grants are merely for infrastructure for states to set up their individual transformation plans for a recovery oriented system and that the Action Agenda is "not really a blueprint or road map for implementing the NFC report."  If all of this is true, then: Every one of these organizations has a vested interest in expanding the mental health system and has been a wholesale, uncritical supporter of the screening and medication recommendations in the NFC report, completely ignoring contradictory scientific and medical evidence.
 
There is also a large conflict between your statements above and the fact that states have taken the NFC recommendations as official administration policy that would have had or will have disastrous consequences. Illinois and Indiana have passed legislation implementing child mental health screening and other scientifically invalid mental health programs that clearly reference the NFC report in their legislative language, supporting documents or implementation plans.  Texas and Minnesota tried to do the same, but were stopped.  Nineteen states have applied for state incentive transformation grants[4] and 45 states received technical assistance from organizations paid by SAMHSA to implement the NFC recommendations[5] mental health screening of children, medication algorithms, and even in the case of Missouri[6] using tax dollars to train families to lobby for more tax dollars to pay for these scientifically invalid programs as discussed below. 

Medication Algorithms:
 
Another example of an apparent disconnect between your statements and reality are your statements that: "The Action Agenda does not support medication algorithms; Medication toolkits have been removed from SAMHSA's other public materials;" and "Algorithms needed to be revisited and revised on the basis of what science has taught us about these drugs."
 
While we appreciate these statements, they do not exonerate SAMHSA from having adopted illegitimate, scientifically invalid, prescription drug practice guidelines based on fraudulent claims.
 
The TMAP algorithm guidelines for psychotropic drugs are not backed by scientific evidence, but rather on self-interested opinion. Indeed the scientific evidence contradicts all claims made about the superiority of the drugs recommended by TMAP as first line treatmentthese drugs have not been shown to be either more effective or safer than non-drug interventions or existing, cheaper, old drugs.  TMAP guidelines were formulated by a consensus panel whose opinions were solicited by pharmaceutical companies that sponsored TMAP. The TMAP formularies recommend the drugs manufactured by those companies that are all on patent, very expensive, and have no better safety or effectiveness profiles than older, cheaper drugs that themselves are not very safe or effective.
 
In light of the validated scientific evidence, your statements were the only reasonable ones to make.  Here is a small sample of that scientific evidence demonstrating: We are truly appalled and alarmed that the New Freedom Commission recommended TMAP and that SAMHSA was directly funding it until recently without ever examining the scientific validity of the recommendationsor the underlying conflicts of interest behind the recommendations. NFC recommendation and funding by SAMHSA helped TMAP spread from Texas to about a dozen other states where thousands of mental patients and children trapped in government programs such as juvenile justice, welfare, and foster care[12] are forced to take these drugs, when most are not approved for use in children. They are given in unstudied cocktails of up to sixteen drugs, starting as young as age three.  The State Incentive Grants for Transformation and the Garrett Lee Smith Suicide Prevention law are both funding TMAP-style "integrated treatment" administered by SAMSHA.

We also remain deeply concerned about items in the Action Agenda that are not backed by scientific evidence. For example, the fact that psychotropic medications are at the top of the list of so-called evidence-based treatments, and the plan to: "Synthesize available knowledge about clinical and rehabilitation practice in each of four understudied areas, including information on ... The long-term positive and negative effects of psychotropic medications for maintenance treatment of mental disorders, particularly for children with serious emotional disturbances." The evidence is in.  The studies have been done. Psychotropic drugs are not safe or effective for children. 

There should be no recommendation by, funding from, or administration of ANY mental health program by SAMSHA, whether in the Agenda or not, that is not backed up by solid, independent, peer reviewed scientific research clearly demonstrating safety and efficacy of any screening or treatment modality.

Screening for Mental Illness:

Screening for suicide has no scientific validity. Indeed, the US Preventative Services Task Force found that suicide screening in general is not effective in preventing suicide or lowering suicide rates[13]. At our meeting you indicated that TeenScreen is not a model program in the Action Agenda; that parental consent for screening must be truly informed and active; and that you will take back information to improve parental consent in the requests for grant applications. 

Again, while we appreciate these statements, we are deeply disappointed and concerned about the announcement, just days after our meeting, that SAMHSA gave $9.7 million dollars in grants to Arizona, Nevada, New Mexico and New York to implement TeenScreen[14]. TeenScreen purports to be a suicide prevention initiative without evidence to back it up. Thus, it is inconceivable that SAMHSA would even consider continuing to promote this ineffective and dangerous program.
 
Infant and Preschool Mental Health Programs:
 
One example of a non-pharmacological mental health program discussed in the Action Agenda that has no scientific evidence of safety and efficacy is the "5-year research effort [launched by HHS and ED] to find the best ways to prepare preschool children for later success in school."  This effort is to include preschool curricula, teacher training, and parental involvement. 
 
The FMHAA also describes HRSA's State Maternal and Child Health Early Childhood Comprehensive Systems (SECCS) Grants that "will bring in other Federal partners to plan for and develop statewide systems of care to support the healthy social and emotional development of children. These grants enable States to plan, develop, and implement comprehensive, collaborative systems to improve childhood outcomes," including "mental health and social-emotional development interventions, early child care and educational supports, and parent education and family support."
 
Besides both preschool and government mental health intervention in the lives of young children violating parental roles evidenced by hundreds of years of historical and court precedent[16], the results of a University of California Berkley/Stanford study confirmed earlier NICHD[17] research showing that increased preschool attendance has negative effects on childrens social and emotional development[18].  This is continued confirmation of research from as far back as the 1960s[19].  Preschool education is harmful to social and emotional development, the very realms that the FMHAA agenda is trying to improve.  Widespread expansion of these programs is in large part responsible for the rampant, though unscientific use of psychotropic drugs in young children[20] and the high rate of preschool expulsions for behavior problems[21].
 
The federal government should not be promoting more wasteful, ineffective government preschool programs that are paid for by higher taxes that force more mothers to join the workforce and put their children in the very programs that are harming them.  We would want to see the language supporting preschool curricula and federal involvement in that realm taken out of the Action Agenda on paper as well as out of the grants that SAMHSA, ACF, MCHB, HHS, and the Department of Education, in implementing the Action Agenda, fund and support.
 
Even more disturbing than the promotion of harmful and ineffective preschool education and mental health programs, is the targeting of infants by programs directly mentioned in the Action Agenda or their documents.  For example:
"SAMHSA's Prevention and Early Intervention Grant Program is a Targeted Capacity Expansion (TCE) grant designed to develop mental health promotion and early intervention services targeted to infants, toddlers, preschool, and school-aged children, and/or to adolescents in mental health care settings and other programs that serve children and adolescents."
The SECCS program mentioned in the Action Agenda references a document that discusses Universal/Preventive Services that are aimed at improving child development, parenting, knowledge and behavior, and infant mental health for all families within their service range. The first service listed under that category is screening.[22]
 
Given the inaccuracy of psychiatric diagnosis and the lack of proven safe and effective treatments in preschool aged children, the NFC reports discussion of mental health in that age group was terrible enough, but for the FMHAA to involve the infant age group is unconscionable. In 2001, Dr. Benedetto Vitiello, director of Child and Adolescent Treatment and Preventive Interventions Research Branch for the National Institutes of Mental Health, acknowledged the diagnostic uncertainty surrounding most manifestations of psychopathology in early childhood [23]. The 1999 Surgeon Generals report on mental health[24] and the 2001 World Health Report[25] on mental health contain similar statements.
 
Any programs involving infants should be completely dropped.
 
Since the Agenda reflects plans of dozens of agencies and departments and is to lead to "wholesale transformation of the mental health service system," we think that it is essential to have accurate language. Therefore, we also thank you for being willing to change the language of the Agenda to reflect concerns raised at the meeting and other concerns. However, we also believe that unless the actions of SAMHSA and the other agencies involved in the Agenda agree with your positive statements during the meeting and the improved language in the FMHAA on parental consent, that working on the Agenda language will merely be symbolism over substance.
 
In summary, the encouraging comments we heard from you at our meeting and in the Action Agenda have been and continue to be contradicted by the actions of your agency. Please let us know how we can interpret the evidence any other way. Those contradictions require us to raise an alarm to the public, Members of Congress, the media, and all of the organizations that oppose the NFC recommendations.
 
We urgently await your response to this letter.
 
Sincerely,
 
Association of American Physicians and Surgeons (AAPS)
International Center for the Study of Psychiatry and Psychology (ICSPP)
Alliance for Human Research Protection (AHRP)
MindFreedom International
Liberty Coalition
EdWatch
Citizens for Health
 
[1] http://www.samhsa.gov/Matrix/brochure.aspx , emphasis added
[2] http://www.samhsa.gov/Federalactionagenda/NFC_FMHAA.aspx, emphasis added 
[3] http://www.nasmhpd.org/targeted_ta.cfm , emphasis added
[4] http://www.nasmhpd.org/general_files/publications/tta_pubs/NASMHPD/IDIQ%20II/Mental%20Health%20Transformation%20Survey%20070105.doc
[5] http://www.nasmhpd.org/general_files/CPT%20Final%20Report%20justin%20revisions.pdf
[6] Ibid, p. 4
[7] Strattera and the antidepressants are under black box warnings for increased risk of suicide in children and are under investigation for increased risk of suicide in adults.  The old and new antipsychotics are under black box warnings for increased death rates in the elderly.  See http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm to find the warnings on individual drugs.
[8] http://content.nejm.org/cgi/content/abstract/353/12/1209; See also Carey, B. (9/20/05) New York Times, p. F-1; see also http://www.ahrp.org/infomail/05/09/20.php
[9] http://www.ohsu.edu/drugeffectiveness/reports/documents/ADHD%20Final%20Report.pdf
[10] http://jama.ama-assn.org/cgi/content/abstract/293/20/2487; see also http://www.ahrp.org/infomail/05/06/09.php
[11] Leff, J (1992). The international pilot study of schizophrenia: Five-year follow up findings. Psychological Medicine, 22, 131-145 and Jablensky, A. (1992). Schizophrenia: Manifestations, incidence and course in different cultures, a World Health Organization ten-country study. Psychological Medicine, supplement 20, 1-95.
[12] Over 60% of foster children in Texas ( http://www.ahrp.org/infomail/04/11/13.php), nearly two-thirds in Massachusetts ( http://www.ahrp.org/infomail/04/08/11.php), and 55% of foster children in Florida ( http://www.ahrp.org/infomail/03/09/24.php) are on as many as 16 different psychiatric drugs, starting as young as age 3.
[13] US Preventative Services Task Force (5/18/04) Screening for Suicide Risk http://www.ahrq.gov/clinic/3rduspstf/suicide/suiciderr.htm#clinical
[13] http://www.newsrx.com/article.php?articleID=274144
[15] David Shaffer et al. (2004). The Columbia SuicideScreen: Validity and Reliability of a Screen for Youth Suicide and Prevention. Journal of the American Academy of Child and Adolescent Psychiatry, 43(1), 71-79; p. 77
[16] E.g. Pierce vs. Society of Sisters and Meyers vs. Nebraska
[17] Children who experience long hours of child care over the first four years of life are more at risk for showing behavior problems, particularly aggression.  Not only were these children more likely to engage in assertive, defiant, and even disobedient activities, but they were also more likely to bully, fight with, or act mean to other children. - The NICHD Early Child Care Research Network as quoted on the Society for Research on Child Development website at http://www.srcd.org/pp1.html
[18] http://pace.berkeley.edu/summary_23DA10_new.doc
[19] Moore, R. and Moore, D. (1975) Better Late Than Early, Readers Digest Press, pp. 88-99
[20] Zito, J., et al. (2/23/00) Trends in the prescribing of psychotropic medications to preschoolers. Journal of the American Medical Association, 283:1025-1030
[21] http://www.fcd-us.org/PDFs/NationalPreKExpulsionPaper03.02_new.pdf
[22] http://www.healthychild.ucla.edu/Publications/Documents/IMH%20executive%20summary%2012.pdf , p. 7 Emphasis added.
[23] Vitiello, B. (2001) Psychopharmacology for young children: clinical needs and research opportunities. Pediatrics. 108: 983-990.
[24] Childhood and adolescence being developmental phases, it is difficult to draw clear boundaries between phenomena that are part of normal development and others that are abnormal. - World Health Organization (2001) World Health Report Mental Health: New Understanding, New Hope, p.50 of pdf, http://www.who.int/entity/whr/2001/en/whr01_en.pdf
[25] The science is challenging because of the ongoing process of development. The normally developing child hardly stays the same long enough to make stable measurements.  Adult criteria for illness can be difficult to apply to children and adolescents, when the signs and symptoms of mental disorders are often also the characteristics of normal development.  - (1999) Surgeon Generals Report on Mental Health, p. 7 of pdf, http://www.surgeongeneral.gov/library/mentalhealth/pdfs/c3.pdf

For more background, read:
Federal Mental Health Agency Responds to EdWatch and Other Groups
Sounding the alarm: Infant mental health
Bias as Mental Illness