UNITED STATES OF AMERICA
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FOOD AND DRUG ADMINISTRATION
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PUBLIC HEARING
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WEDNESDAY,
NOVEMBER 2, 2005
Our next speaker is Ellen Liversidge, a speech pathologist, who will be speaking.
MS. LIVERSIDGE: Good morning, ladies and gentlemen.
My name is Ellen Liversidge from Silver Springs, Maryland. I'm a speech pathologist and board member of AHRP, the Alliance for Human Research Protection.
But most of all I'm the parent of a wonderful son who was killed by a prescription drug. Rob died of profound hyperglycemia on October 5th, 2002, back before the FDA had gotten around to placing a warning on the label, back before Eli Lilly had a settlement with 8,000 people harmed or killed by Zyprexa, back before we had any idea that there was any danger.
When I found out after his death from Public Citizen that other countries had required Lilly to place warnings on the label, I desperately tried to change the situation in this country. Working with reporters and the Baltimore Sun and the Wall Street Journal trying to get and getting front page articles about the dangers of Zyprexa.
Erica Wood of the New York Times followed up with another front page story, and finally, a year later, the FDA ordered all the atypical anti-psychotics to place a warning for diabetes, hyperglycemia, and death.
I speak today on behalf of AHRP, and also on behalf of all the parents I have met whose sons and daughters have been lost to psychotropic drugs. We are a band of brothers and sisters when get together, having had the worst possible thing in all the world happen to us and to our innocent children.
Most of all, it is for the innocent children that are alive that I speak today, giving you AHRP's position on the very nefarious direct to consumer advertising scheme called Teen Screen, dreamt up by pharma and funded by the federal government. This plan will give unvalidated questionnaires to all the teens in every high school in the country, providing many of them with false, possibly false, psychiatric labels, and referring them to a doctor for probable medication, thus creating a new market share for the industry.
AHRP's position on this scheme is as follows. The Alliance for Human Research Protection 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 consideration.
Number one, the primary catalyst for both Teen Screen and for the prescribing guidelines, known as TMAP, is market expansion. Dr. Peter Weiden, who is a member of TMAP - it stands for the Texas Medication Algorithm Project - 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 guidelines' authors have received support from the pharmaceutical industry.
The invalid screening process of Teen Screen ensures that mostly healthy normal children will be brought into government subsidized mental health dragnet. Once children acquire a psychiatric label they may be branded for life. For example, between 55 and 60 percent of foster children in at least three states - Texas, Massachusetts and Florida - are on psychotropic drugs starting as young as age three.
Some children are on multiple drug cocktails, as many as 16 drugs. The drugs that are recommended by TMAP are both dangerous and often ineffective. They all carry black box warning labels.
Two, the diagnostic criteria upon which mental health screening instruments rest are scientifically invalid, vague and entirely open to subjective interpretation. Teen Screen was tested on 1,729 children in seven New York City schools using passive parental consent and teen active consent, which is legally invalid.
Teen Screen 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, and that's one of the questions, screening might lead to suicidal thinking, as happens in Japan's Internet suicide clubs.
Teen Screen questions are so vague, suggestive and broad that most normal teens are mislabeled as mentally ill.
Teen Screen, also known as Columbia suicide screen, 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 the study by Dr. David Schaeffer, chairman of child and adolescent psychiatry at Columbia University who is credited with developing and promoting Teen Screen showed that of 1,729 New York City high school students who were screened using the questionnaire, 475 students tested positive.
Number three, mental health screening is gambling with children's normal development. Teen Screen promoters fail to disclose that the risk for children who are screened to be falsely labeled as suicidal or mentally ill is 84 percent.
Number four, despite its proven unreliability as a predictive tool, and no evidence that mental health screening prevents suicide, Teen Screen promotes itself in direct to consumer marketing advertisements as a suicide prevention tool, proving that science is no deterrent to a marketing strategy.
The Teen Screen 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. Teen Screen promoters are misinforming public health policymakers, 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.
Teen Screen's low predictive level shown to be only 16 percent, will result in falsely 84 percent of children who test positive as mentally ill or suicidal.
As acknowledged by Dr. Schaeffer, such a high rate of false positives could reduce the acceptability of a school-based prevention program.
Number five, coercive mental health screening and forced drugging is already happening to children in the United States. Current estimates are that each year 8 million American children, or about 10 percent of the school age population are prescribed mind-altering drugs.
Finally, a radical proposal contained in the federal mental health action agenda, a follow up to the NFC, is alarming as it is preposterous. The FMHAA's stated goal is to develop mental health promotion and early intervention services targeted to infants, toddlers, preschool and school age children. The action agenda, targeting infants, toddlers and children, is invalid and irresponsible, and disregards the risks, the lack of evidence to support such, quote, early intervention.
In 2001 Dr. Benedetto Ditiello, director of child and adolescent treatment and prevention interventions research branch for the National Institutes of Mental Health, acknowledged the diagnostic uncertainty surrounding most manifestations of psychopathology in early childhood.
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. Teen Screen has attempted to sidestep parental consent by claiming passive parental consent, which is invalid.
Teen Screen is being sued in federal court by the parents of 15-year-old Chelsea Rhodes for violating their constitutional rights by failing to inform them that their child would be screened, and for failing to obtain parental consent.
The Rhodes family is represented by the Rutherford Institute.
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 25th of this year, Teen Screen is actively operating at 460 locations in 42 states and Washington, D.C.
Thank you.
MR. ABRAMS: Thank you for your presentation and sharing your thought.
Before I open the questions up to questions by the FDA panel, I want to make it clear the rules of a Part 15 meeting, that FDA is here to listen, to get your information. So we are not allowed to respond to comments or answer questions. I think that is important. The purpose of the meeting is to gather information.
So with that I'll open it up to the panel members.
Dr. Temple.
DR. TEMPLE: You mentioned that some direct to consumer ads are mentioning and promoting Teen Screen. I checked. We don't think we're aware of that. Can you either now or afterwards identify those for us so we can look at them?
MS. LIVERSIDGE: What I can identify for you now is what is stated in my statement that I got from AHRP. But I do not have any information in any public document.
DR. TEMPLE: Well, even if you went back to them and asked them?
MS. LIVERSIDGE: I would be happy to do that.
MR. ABRAMS: Thank you for your presentation. And any additional information please submit to the docket, and we will carefully consider it.
Thank you.