MENTAL HEALTH, EDUCATION AND SOCIAL CONTROL
Part 26

 

 

 

By Dennis L. Cuddy, Ph.D.
February 20, 2006
NewsWithViews.com

In Part 25 of this series, I referred to TMAP (Texas Medication Algorithm Project) and TeenScreen. As an update on these, it is useful to look at the testimony of Ellen Liversidge to the U.S. Food and Drug Administration (FDA) on November 2, 2005. A speech pathologist and board member of AHRP (Alliance for Human Research Protection), Ms. Liversidge testified that "Dr. Peter Weiden, who is a member of 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 guidelines' authors have received support from the pharmaceutical industry.

The invalid screening process of TeenScreen 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....The diagnostic criteria upon which mental health screening instruments rest are scientifically invalid, vague and entirely open to subjective interpretation. TeenScreen was tested on 1,729 children in seven New York City schools using passive parental consent and teen active consent, which is legally invalid. TeenScreen is fraught with suggestive insinuations of failure and self-doubt.

Such questions can lead vulnerable teenagers to obsess about perceived inadequacies....By raising the possibility that suicide may be an option, and that's one of the questions, screening might lead to suicidal thinking....TeenScreen promoters fail to disclose that the risk for children who are screened to be falsely labeled as suicidal or mentally ill is 84 percent....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 sidestep parental consent by claiming passive parental consent, which is invalid....According to its website, as of October 25th of this year (2005), TeenScreen is actively operating in 460 locations in 42 states and Washington, DC."

Mental health screening is also promoted as identifying ADD (Attention Deficit Disorder) and ADHD (Attention Deficit Hyperactivity Disorder). However, serious warnings have accompanied drugs used to treat these. According to Evelyn Pringle's article, "ADHD Drugs---Cash Cow For Pharma" (LAWYERS AND SETTLEMENTS, February 13, 2006): "In a February 6, 2006, letter to acting FDA commissioner, Dr. Andrew von Eschenbach, U.S. Senator Charles Grassley pointed out that in September of 2005, the FDA had issued an alert to healthcare professionals regarding the use of Strattera (ADHD drug), after reviewing data showing an increase in suicidal thoughts in 12 separate studies, and directed Eli Lilly, to 'revise the labeling...to include a boxed warning and additional warning statements regarding an increased risk of suicidal thinking in children and adolescents.'

As an added pressure, Sen. Grassley asked for a complete list of names of participating panel members and a complete list of conflict disclosures for both the February 9-10, 2006, advisory committee and the March 22, 2006, Pediatric Advisory Committee....At the February 10 FDA advisory committee hearing, it was reported by Dr. Andrew Mosholder, a medical officer in the FDA's Office of Drug Safety, that about 2.5 million children in this country, between the ages 4 and 17, currently take ADHD drugs....In 1991, schools began receiving educational grants of $400 annually for each ADHD child." Could this financial incentive be one of the reasons for the increase in children placed upon ADHD drugs?

The day before the FDA advisory committee hearings began, ABC News on February 8, 2006, covered an Associated Press report, "FDA reports 51 deaths of attention drug patients," by Andrew Bridges who revealed that "deaths of 51 U.S. patients who took widely prescribed drugs to treat Attention Deficit Disorder prompted regulators to start watching for heart attacks, high blood pressure and other problems in 2004, a report released on Wednesday said.

The U.S. Food and Drug Administration staff did not say the drugs were responsible for the fatalities, but they urged close monitoring for 'the rare occurrence of pediatric sudden death during stimulant therapy.'...The information was released one day ahead of an FDA advisory panel meeting on how best to study potential risks from the drugs, which include Shire Pharmaceuticals Group Plc's Adderall and Novartis AG's Ritalin....Use of drugs to treat attention deficit hyperactivity disorder, or ADHD, was controversial before the cardiac issue emerged, with many doctors and parents arguing the medicines are overprescribed....Through 2003, 24 deaths were reported from 1999 through 2003 among U.S. patients who took Adderall for ADHD, the FDA staff report said....Another 16 deaths were reported through 2003 in U.S. patients who took Ritalin or other ADHD drugs known as methylphenidates, the report said."

Further concerning ADHD, Vicky Dunkle (representing Ablechild of Pennsylvania) on February 10, 2006, had written testimony presented to the FDA that her daughter (Shaina) died on February 26, 2001, from drug toxicity. She wrote: "Parents are simply not being given the facts on these psychiatric labels and the recommended drugs' inherent dangers. Parents are all too frequently being pressured into placing their child on these psychotropic drugs by their child's school....We were never given full informed consent. We were never told that the label ADHD itself was both subjective and controversial or that the drug prescribed had many dangerous risks including death.

Desipramine was the drug given to my daughter and we were led to believe this drug was safe and effective in what was described to us as her 'treatment.' We were never informed that this drug was not FDA approved for children of Shaina's age, lacking both safety and effectiveness....Shaina died due to Desipramine toxicity. Little also did we know that we would be reading proof that there had been prior child deaths as far back as 1990 from this one drug. My husband (Steve) and I believed and trusted in the professionals and they only helped me bury our child at 10 years old....What is clear and definite to both my husband and me now is that if we would have been given the right information we would have NEVER placed our daughter on this drug.

If we had been informed correctly on the lack of objective testing used to determine this psychiatric label and the lack of science to back it as a true 'disease,' we would have NEVER placed our daughter on any drugs. We ask this panel to take the time to review the real risks involved in placing children on these drugs and ask yourselves, 'What if it had been my child or family member who was to die from one of these drugs prescribed?' 'What if I wasn't told the facts?' 'How would I feel?' More importantly, 'Does Death as a side effect outweigh any possible benefits?' At the very least, this panel must do something regarding the violation of informed consent rights occurring with the widespread use of these drugs being prescribed to children."

Testifying in person before the FDA was Clinton Libbey, an Ablechild volunteer, who told the hearing panel: "As a concerned parent, I investigated the drugs that were being considered for my son, many of which are being reviewed by this panel currently. What I found was misinformation and distortions pertaining to both the subjective psychiatric labels being assigned to our children and the drugs being prescribed to them....When dealing with drugs that have known side effects, the oath of first do no harm must be transformed to first do no harm without full informed consent....This is especially the case when the treatment may cause the one side effect that is irreversible---Death....I, for instance, was misinformed when several medical doctors told me that no one has died as a result of taking these drugs provided that they are taken in accordance with the dosage guidelines....Upon further investigation, I found parents who had lost their children due to these drugs with autopsy reports directly linking ADHD drugs with their children's deaths.

The fact is that children have died even though dosage recommendations on an approved label were strictly adhered....As a society, we must disclose potential side effects prior to treatment in order to guarantee an individual's right to full informed consent....While many say that there needs to be more research on these drugs, I, with the parents that make up Ablechild, many of whom are victims of the effects of these drugs, find that stronger warning labels and stiffer guidelines regulating full disclosure would be a more appropriate step. Furthermore, Medwatch filings should be mandatory for adverse reactions within the pediatric population....Please don't allow another child to lose her or his life without at least warning their parents."

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According to Evelyn Pringle's article mentioned above, "On February 10, 2006, the Drug Safety and Risk Management advisory committee (of the FDA) said that ADHD drugs should carry the strongest warning label that they may be linked to an increased risk of death and injury." Pringle went on to warn that "for school age children, these drugs are providing a spring-board into early addiction."

For other parts of this series, click here -----> 1

� 2006 Dennis Cuddy - All Rights Reserved

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