AHRP Position Statement on Mental Health Screening – FDA Hearing Re: Drug Advertising

Wed, 02 Nov 2005

FDA is holding public hearings (Nov 1, 2) Re:  Direct-to-Consumer Promotion of Medical Products
at: National Transportation Safety Board Boardroom and Conference Center 429 L’Enfant Plaza, SW., Washington, DC 2
Time: 9:00 –5:00.

Ellen Liversidge will submit testimony and represent the Alliance for Human Research Protection.

She will testify about a widely advertised Eli Lilly drug, Zyprexa (olanzapine), whose ads have made it a $4 billion blockbuster.

But failure to disclose the severe, potentially lethal effects of Zyprexa–including diabetes, hyperglycemia, pancreatitis, ketoacidosis, and diabetic coma–led to preventable deaths, including the death of her son, Rob, who died in 2002 of hyperglycemia.

See, front page news report, Baltimore Sun: https://ahrp.org/infomail/0303/20.php

The FDA did nothing–even after a Duke University study of FDA’s Medwatch reports documented an alarming link to diabetes.

See: The Journal of the American Medical Association ( November 28, 2001) letter written by Dr. Elizabeth Koller, an FDA medical officer, Dr. P. Murali Doraiswamy, a Duke University psychiatrist warning that FDA’s MedWatch data shows that patients taking either olanzapine or clozapine were 10 times more likely to become diabetic than the general population. http://jama.ama-assn.org/issues/current/ffull/jlt1128-4.html Vol. 286 No. 20.

In 2002, the Japanese Health and Welfare Ministry and UK Medicines Control Agency issued emergency Zyprexa warnings, the FDA still did nothing.

Indeed, Zyprexa is listed as a first line preferred treatment in the TMAP (Texas Medication Algorithm Project) prescribing guidelines.

Not until 2003 did the FDA require black box label warnings for Zyprexa and the other six antipsychotic drugs, alerting prescribers and patients to the possibility of the drugs’ leading to the development of potentially fatal diabetes mellitus.

This year, Lilly agreed to pay a $690 million settlement for 8,000 Zyprexa-diabetes plaintiffs. However, the settlement is sealed so the drug’s adverse effects are still not fully known to prescribing physicians or the public.

Ellen Liversidge will also present AHRP’s Position Statement on Mental Health Screening: TeenScreen, a Marketing Strategy.

Contact: Vera Hassner Sharav
212-595-8974

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
www.ahrp.org

Position Statement on Mental Health Screening:
TeenScreen, a Marketing Strategy

November 1, 2005

The ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) opposes government policies requiring or promoting mental health screening of America’s infants, toddlers and school children. Our opposition is informed by scientific, legal, ethical, and common sense considerations.

1) The primary catalyst for both TeenScreen and for the prescribing guidelines, known as TMAP is market expansion.

Both TeenScreen and TMAP (the Texas Medication Algorithm Project) were recommended by the President’s New Freedom Commission for Mental Health (NFC) Report.

To appreciate the financial stakes involved in the psychotropic drug business, one must only look at the staggering rate of return on investment. Companies that subsidized TMAP increased their rate of return hugely – not only in Texas, but nationwide.

 

CBS-affiliate, KEYE News Investigation [2]

Dr. Peter J Weiden, who was a member of the TMAP expert consensus panel, has charged that the guidelines are based on “opinions, not data” and that “bias due to funding sources undermines the credibility of the guidelines since most of the guideline’s authors have received support from the pharmaceutical industry.” [3]

The invalid screening process of TeenScreen ensures that mostly healthy normal children will be brought into the government subsidized mental health dragnet. Once children acquire a psychiatric label, they are branded for life. For example, between 55% and 60% of foster children in at least three states–Texas [4], Massachusetts [5], and Florida [6]–are on psychotropic drugs, starting as young as age three. Some children are on multiple “drug cocktails,” as many as 16 drugs.

The treatments and interventions for psychiatric labels resulting from mental health screening are almost exclusively pharmacological in nature.

The drugs recommended by TMAP are both dangerous and ineffective – they all carry Black Box warning labels.

2) The diagnostic criteria upon which mental health screening instruments rest are scientifically invalid, vague, and entirely open to subjective interpretation.

·       Indeed, in 1999, the US Surgeon General [7] acknowledged: “what it means to be mentally healthy is subject to many different interpretations that are rooted in value judgments that may vary across cultures.” The clinician’s guide to diagnosing mental disorders, the DSM IV, acknowledges: “The DSM-IV [8] criteria remain a consensus without clear empirical data…the behavioral characteristics specified in DSM-IV, despite efforts to standardize them, remain subjective . . . ” p.1163

1. TeenScreen was tested on 1,729 children in 7 New York City schools using “parental passive consent and teen active consent” [9] which is legally invalid.
2. TeenScreen is fraught with suggestive insinuations of failure and self-doubt. Such questions can lead vulnerable teenagers to obsess about perceived inadequacies that might lead them to develop low self-esteem that could give rise to anxiety, withdrawal, and emotional problems. By raising the possibility that suicide may be an option, screening might lead to suicidal thinking – as happens in Japan’s Internet suicide clubs. [10]
3. TeenScreen questions are so vague, suggestive, and broad that mostly normal teens are mislabeled as “mentally ill:”

“In the last year … Has there been a time when you felt you couldn’t do anything well or that you weren’t as good-looking or as smart as other people?”

“In the last year…Has there been a time when you couldn’t think as clearly or as fast as usual?”

“Have you often felt very nervous when you’ve had to do things in front of people?”

·TeenScreen (a.k.a. Columbia SuicideScreen, CSS) is an illegitimate intrusion on privacy which purports to be a suicide prevention assessment tool but lacks any semblance of scientific validity. Indeed, the results of a study by Dr. David Shaffer, Chairman of Child and Adolescent Psychiatry, Columbia University, who is credited with developing and promoting TeenScreen, show that of 1,729 New York City high school students who were screened using the TeenScreen questionnaire, 475 students tested positive.

·       He acknowledges that “Two hundred and three (77 percent) of the 262 teens who screened positive at follow up had no evidence of depression or suicidality at follow-up.” 9

1. Further analysis by Dr. Shaffer [11], et al (in 2004) found that when students were retested, the positive predictive value of TeenScreen was only 16%. The authors acknowledge that their screening tool “would result in 84 non-suicidal teens being referred for evaluation for every 16 suicidal youths correctly identified.” [p. 77]
2. Any screening instrument with that high a rate of false positives would be invalidated as useless. Indeed, Dr. Shaffer and colleagues acknowledge: “in practice a specificity of 0.83 would deliver many who were not at risk for suicide, and that could reduce the acceptability of a school-based prevention program.” p. 77
3. Mental health screening is gambling with children’s normal development–TeenScreen promoters fail to disclose that the risk for children who are screened to be falsely labeled as “suicidal” or “mentally ill” is 84%.

A child who is mislabeled as “mentally ill” is likely to be harmed emotionally, psychologically and neurologically – especially if prescribed powerful psychoactive drugs.

“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]

By pathologizing children’s normal developmental changes and emotional expression, nonconforming (often gifted) children are mislabeled as mentally ill. That label stigmatizes them and sets limits on their choices and, therefore, their mental well-being. Promoters of mental health screening fail to acknowledge that children who test “positive” at high risk of being prescribed pharmacological treatments that are not approved for children; that have been shown to be mostly ineffective in industry’s own studies; that even during short-term tests have triggered severe, sometimes fatal side effects. Indeed, most of the psychotropic drugs prescribed for children carry Black Box warnings – FDA’s strongest safety alert.

• The assumption that early biochemical intervention improves children’s future mental health is unsubstantiated. These interventions are controversial and have not been proven safe or beneficial.
  • “However, safety considerations seem to suggest that, when possible, nonpharmacologic interventions should be considered before young children are given medications of unproven efficacy and safety.” [12]

• Most of the prescribed psychotropic drugs were not approved for use in children.
• When tested in children in controlled trials, the drugs were found not to work:

“More than two-thirds of studies of antidepressants given to depressed children, for instance, found the medications were no better than sugar pills, but companies published only the positive trials.”

• Children prescribed these drugs may suffer serious neurological harm; some may become manic, aggressive and suicidal.
• The short-term use of these drugs in children resulted in severe, sometimes fatal side effects.
• All antidepressants now carry Black Box warnings about an increased risk of suicidal behavior, including Strattera, a recycled antidepressant prescribed for ADHD.
• In July, 2005, the FDA issued an additional advisory to healthcare professionals stating:

“FDA has concluded that suicidal thinking or behavior may increase in pediatric patients treated with any type of antidepressant, especially early in treatment.

Increases in suicidal thinking or behavior due to drug can be expected in about 1 out of 50 treated pediatric patients.” [13]

• There are no drug safety studies on long-term consequences for children’s development.
• The Oregon Drug effectiveness Study that reviewed 2,287 studies on ADHD drugs found [14] “No evidence on long-term safety of drugs used to treat ADHD in young children” or adolescents.
• “A landmark government-financed study [CATIE] that compared drugs used to treat schizophrenia has confirmed what many psychiatrists long suspected: newer drugs that are highly promoted and widely prescribed offer few – if any – benefits over older medicines that sell for a fraction of the cost.” [15]

4) Despite its proven unreliability as a predictive tool, and no evidence that mental screening prevents suicide [16], TeenScreen promotes itself in direct to consumer marketing advertisements – as a suicide prevention tool, proving that science is no deterrent for a marketing strategy.

• The TeenScreen website states: “We are running public service advertisements in The New York Times and The Washington Post to raise awareness of our new report entitled “Catch Them Before They Fall.”
• “Catch Them Before They Fall” is a marketing pitch much like pharmaceutical company advertisements that refer to unsubstantiated “chemical imbalances.”

TeenScreen promoters are misinforming public health policy makers, school officials, families and teens by mischaracterizing their experimental, scientifically invalid questionnaire as a proven suicide prevention strategy, when their own research refutes such claims. TeenScreen’s low predictive level – shown to be only 16% – will result in falsely labeling 84% of children who test positive as mentally ill or suicidal.11 As acknowledged by Dr. Shaffer, such a high rate of false positives “could reduce the acceptability of a school-based prevention program.” TeenScreen seemingly driven by marketing considerations continues to make unfounded claims that belie the evidence. As a result, healthy children are increasingly prescribed psychotropic drugs that have been shown to be harmful.

AHRP is dismayed that the government is wasting tens of millions of taxpayers’ dollars for scientifically invalid mental health screening programs that are more likely to harm than help children. Most recently the federal Substance Abuse Mental Health Services Administration (SAMHSA) awarded $9.7 million [17] to support 37 “suicide prevention” screening programs.

• TeenScreen suggests ways of circumventing a federal law mandating parental consent (Protection of Pupil Rights Amendment (PPRA), a child’s only protection from these invasive unproven initiatives:

“If the screening will be given to all students, as opposed to some, it becomes part of the curriculum and no longer requires active parental consent (i.e., if all ninth graders will be screened as a matter of policy), it is considered part of the curriculum.” [18]

• TeenScreen pitches its product to under age minors who are legally and developmentally incapable of making experimental health care decisions whose consequences they cannot fathom.

5) Coercive mental health screening and forced drugging is already happening to children in the United States. Current estimates “Each year, eight million American children, or about 10% of the school-age population, are prescribed mind altering drugs.

• Aliah Gleason is an example of the tragic consequences of being falsely labeled by TeenScreen. After screening “positive” in a Texas school mental health screening, without parental consent, Aliah was committed to a state mental hospital, denied family contact for five months, physically restrained over 26 times, and forcibly drugged with twelve psychiatric medications. [19]
• Mathew Smith and Shaina Dunkle died due to cardiac toxicity of psychotropic drugs that their parents were forced to put them on by their schools.
• In New York, Patricia Weathers [20] and the Carroll [21] family were threatened or charged with child abuse for wanting to take their sons off of stimulant medications following adverse reactions.
• Paul Johnson started kindergarten as a normal 5 year old, but his teacher decided that he had ADHD. Paul’s parents were threatened with child abuse charges and so over the next 7 years he was medicated with seven different psychiatric medications and endured institutionalization for drug-induced psychosis. [22]

6) Finally, a radical proposal contained in the Federal Mental Health Action Agenda (FMHAA) – a follow-up to the NFC, is alarming as it is preposterous. The FMHAA stated goal is: to “develop mental health promotion and early intervention services targeted to infants, toddlers, preschool, and school-aged children.” [23]

• The Action Agenda targeting infants, toddlers, and children is invalid and irresponsible – as it disregards the risks and lack of evidence to support such “early intervention.”
• In 2001, Dr. Benedetto Vitiello [24], 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.”
• Whereas Dr. Vitiello acknowledged “multiple concerns” about “a sizable increase in the use of psychotropic medications such as stimulants, antidepressants, and clonidine in children, including preschoolers aged 2 to 5 years. [ ] None of the medications identified in the surveys has received regulatory approval for children
• The following statement by Dr. David Willis, Medical Director of the Northwest Early Childhood Institute in Portland, Oregon, a key opinion leader with influence on government policies affecting children’s mental health, is a shocking prescription for disaster given the lack of reliable diagnostic instruments, the high rate of error ensuring healthy children would be mislabeled, and the drugs’ severe adverse effects:

“Psychopharmacology is on the horizon as preventive therapy for children with genetic susceptibility to mental health problems.” [25] (Emphasis added).

• Mental health screening and early psychopharmacological interventions, particularly for infants and young children, has no more scientific validity or ethical legitimacy than did the mass screening for Œmental defectives’ during the heyday of the U.S. eugenics movement. Those ill-advised screening policies led to the sterilization of 72,600 Americans, among them children as young as 10. [26]

AHRP opposes psychiatric screening of children without active, informed, parental consent.  Consent of parents must be documented and given voluntarily without a hint of coercion. TeenScreen has attempted to side-step parental consent by claiming “passive parental consent” – which is invalid.

• TeenScreen is being sued in federal court by the parents of 15-year old Chelsea Rhoades, for violating their constitutional rights by failing to inform them that their child will be screened, and for failing to obtain parental consent. The Rhoades family is represented by the Rutherford Institute. [27]

The FDA bears responsibility for failing to stop an unethical drug marketing strategy that is increasing the risk of serious harm for healthy children who are being misprescribed psychoactive drugs on the basis of an invalid screening tool that was being promoted with false claims. According to its website, as of October 25, 2005, TeenScreen is actively operating at 460 locations in 42 states and Washington DC. [28]

References

[1] http://www.mentalhealthcommission.gov/

[2] Wilson N., KEYE News Investigates. (July 23, 2004) Psychiatric drugs and (September 30, 2004) Drugs and your tax dollars. http://keyetv.com/investigativevideo

[3] Dr. Weiden quoted by Lenzer, Jeanne (5/15/04) British Medical Journal, http://bmj.bmjjournals.com/cgi/content/full/bmj;328/7449/1153

[4] AHRP (11/13/04) Texas Foster Care Investigation – Children as young as 3 are drugged with antipsychotics https://ahrp.org/infomail/04/11/13.php

[5] AHRP (8/11/04) Two-thirds foster care children in Mass on psych drugs – Globe https://ahrp.org/infomail/04/08/11.php

[6] AHRP (9/24/03) Babies given mind altering drugs in Florida https://ahrp.org/infomail/03/09/24.php

[7] Surgeon General’s Report on Mental Health, (1999) p. 7 of pdf, http://www.surgeongeneral.gov/library/mentalhealth/pdfs/c3.pdf

[8] American Psychiatric Association Committee on the Diagnostic and Statistical Manual (DSM IV- 1994), pp.1162-1163

[9] David Shaffer, et al (date ?) High-school screening for suicidality: Implications for young adults, American Foundation for Suicide Prevention, http://www.afsp.org/education/shaff_pc.htm

[10] Andrew Harding. (December 7, 2004) Japan’s Internet “Suicide Clubs” BBC Asia

[11] 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.

[12] Vitiello, B. (10/2001) Psychopharmacology for Young Children: Clinical Needs and Research Opportunities Pediatrics, Vol. 108, No. 4, pp. 983-989

[13] http://www.fda.gov/cder/drug/InfoSheets/HCP/sertralineHCP.htm

[14] M. ALEXANDER OTTO. (September 13, 2005) Are ADHD drugs safe? Report finds little proof; The News Tribune. See: https://ahrp.org/infomail/05/09/13a.php

[15] Vedatam, S. (September 20, 2005) New Antipsychotic Drugs Criticized, Federal Study Finds No Benefit Over Older, Cheaper Drug, Washington Post, p. A01; and Carey, B. Study Finds Little Advantage in New Schizophrenia Drug (9/20/05) New York Times, p. F-1. See: https://ahrp.org/infomail/05/09/20.php

[16] US Preventative Services Task Force (5/18/04) Screening for Suicide Risk http://www.ahrq.gov/clinic/3rduspstf/suicide/suiciderr.htm#clinical

[17] News from NYS Office of Mental Health http://www.eisinc.com/release/storiesh/NYSOMH.138.html

[18] TeenScreen News (Fall 2003 ) http://www.antidepressantsfacts.com/TeenScreen-crimin.pdf

[19] Waters, R. (May/June 2005) Medicating Aliah, Mother Jones, http://www.motherjones.com/news/feature/2005/05/medicating_aliah.html, enter code MJZL6Y

[20] Montero, D., (8/7/02) I was forced to dope my kid, The New York Post at http://www.nypost.com/news/regionalnews/54243.htm last visited 8/30/02

[21] Karlin, R. (7/19/00) Court orders couple to give son drug (Ritalin) after school turns parents in, Albany Times Union)

[22] Eagle Forum (June, 2002) A Parent’s Nightmare: Losing a Child to Drug-Induced Psychosis, Education Reporter, http://www.eagleforum.org/educate/2002/june02/drug-induced.shtml last visited 5/13/03

[23] http://www.samhsa.gov/Federalactionagenda/NFC_FMHAA.aspx

[24] Vitiello, B. (2001) Psychopharmacology for young children: clinical needs and research opportunities. Pediatrics. 108: 983-990.

[25] David W. Willis, M.D. ((January, 2004) Medical Director of the Northwest Early Childhood Institute in Portland, Oregon, as quoted in Pediatric News

[26] Sharav, VH. (Summer 2005) Screening for Mental Illness: The Merger of Eugenics and the Drug Industry Ethical Human Psychology and Psychiatry Volume 7, Number 2.

[27] http://rutherford.org/articles_db/press_release.asp?article_id=579

[28] See: http://www.teenscreen.org/cms/index.php?option=content&task=view&id=81&Itemid=113