This is a follow-up to yesterday's Infomail about a report under the auspices of the National Academies of Science (NAS) which calls for pre-emptive interventions to “prevent” “mental, emotional and behavioral disorders among young people.” The NAS report recommends “rigorous” mental screening, followed by pharmacologic "treatment" intervention with highly toxic psychoactive drugs—antidepressants and antipsychotics—even as the authors acknowledge that: "Early-detection programs will identify as candidates for mental illness some people  who are merely persnickety or shy or eccentric."

The NAS report is one of several U.S. government initiatives aimed at lending legitimacy to, and vastly expanding, the use of the most toxic drugs in pharmacopoeia in children. Most of these children would never be considered candidates for psychiatric diagnosis or treatment in other countries. The implementation of these initiatives will ensnare millions of American children into becoming involuntary consumers of drugs that induce metabolic, hormonal, neurological, cardiovascular damage.

Of note, before the NAS report had even been edited for publication, the Department of Health & Human Services (DHHS) has already established an "Early Detection & Intervention for the Prevention of Psychosis Program" (EDIPPP) to implement  the report’s recommendations.  The problem: there exists not a shred of scientific evidence to support "preventive" cures for psychosis.

The NAS report is replete with expressions such as “bio-markers” for mental disorders, when not a single genetic, chemical, physiological, radiological or any other biological marker has been identified to aid in diagnosis or predicting treatment response of any psychiatric condition in the DSM, psychiatry’s diagnostic manual. As acknowledged in the DSM :
"The DSM-IV criteria remain a consensus without clear empirical data...the behavioral characteristics specified in DSM-IV…remain subjective...”  p. 1163

Yet, in the NAS report DSM diagnoses themselves are absurdly treated as rock-solid descriptions of natural disease phenomena. Not a single of these mental disorder diagnoses’ many contradictions are discussed, let alone assessed critically. The NAS report is not a critical assessment of the evidence by a well-funded panel of prestigious scientists: it resembles a cursory literature review as if written by a naïve undergraduate student.

According to the DHHS “Talking Points” document, "EDIPPP was launched and funded by the Robert Wood Johnson Foundation which has invested $16.9 million in this promising program."  EDIPPP program sites are in Albuquerque, NM; Davis, CA; Glen Oaks, NY; Portland, ME; Salem, OR; and Ypsilanti, MI.

The Robert Wood Johnson Foundation is an arm of Johnson & Johnson, the parent company of Janssen, makers of the antipsychotic drug Risperdal (risperidone). Janssen is being sued by the Texas Attorney General for bilking the state Medicaid / Medicare budget, and for having "improperly influenced the development" of the Texas Medication Algorithm prescribing protocols (TMAP).

The TMAP marketing scheme was initiated by Johnson & Johnson  in 1995 with an investment of $224,000. Psychotropic drug prescribing guidelines were formulated by industry-paid “consensus panels” whose opinions were used to override the scientific evidence about these drugs’ insignificant clinical advantage but severe additional risks. TMAP guidelines were uncritically adopted by state mental health agencies, ensuring that taxpayers would pay exorbitantly for the latest patented drugs.

TMAP precipitated huge overprescribing of psychoactive drugs, especially among the most vulnerable populations. By 2004, Johnson and Johnson reaped $ 272 million in Risperdal sales in Texas alone.

Even more sinister than the bilking of U.S. taxpayers, however, are the signs that EDIPPP resuscitates America's shameful eugenic policies of the first half of the 20th century.

Eugenicists of yesteryear screened families and school children to root out "mental defectives" by means of dubious questionnaires screens to "catch them before they fall." Former eugenicists forced surgical sterilizations on those deemed "mentally defective" based on bogus questionnaires. Emergent American eugenicists promote pharmacological fixes that have the potential for chemically castrating those deemed "mentally ill." 

Even as the EDIPPP tacitly acknowledges the absence of "effective diagnostic tools and interventions" which it "seeks to develop," it promotes controversial pharmacologic interventions on the basis of still-dubious screens and “tests,” stating that  its “purpose is to avoid making a mental illness diagnosis.”   Mental health discourse is defined by circular reasoning.

Below is the short version ("Crib Sheet") of an 18 page internal document distributed to DHHS employees on June 10, 2009. The EDIPPP "talking points" are for public relations purposes. The main justification for the program is stated as follows: "The intervention treats symptoms of mental illness in young people before serious illness occurs."

The clinical benefit of the drugs to be used—primarily SSRI antidepressants and the second generation antipsychotics—remain unproven, especially when they are compared to real-world alternatives under real-world conditions. However, the list of their documented hazards grows. For example, Though little discussed, most people prescribed antidepressants or antipsychotics experience sexual dysfunction which may continue indefinitely, even long after the drugs are stopped.  Among those prescribed SSRI antidepressants, sexual dysfunction occurs in over 60%. (See: Wikipedia.)

Antipsychotics are a major cause of sexual dysfunction (such as decreased libido, impotence and erectile dysfunction, impaired orgasm, abnormal ejaculation, priapism, enlarged breasts in boys). These effects occur as a result of dopamine, histamine, and cholinergic receptor antagonism, which result in sedation, impaired motivation and reward, hyperprolactinemia, and reduced peripheral vasodilation (causing a decrease in blood flow). A review in Human Psychopharmacology (2008) found the following:

“The rate of sexual dysfunction among men and women receiving haloperidol [an older antipsychotic] for 12 months is more than 70%” (p. 206).

“Risperidone [Risperdal] treatment is associated with sexual dysfunction in the majority of patients who receive it... Evidence from large-scale, naturalistic studies shows that 60–70% of patients receiving risperidone in the clinical setting experience sexual dysfunction, similar to rates seen with haloperidol” (p. 203).

“Sexual dysfunction, including decreased libido and impotence, occurs in more than 50% of patients receiving olanzapine [Zyprexa]” (p. 206).

 “Sexual dysfunction rates with quetiapine [Seroquel] are 50-60%” (p. 206).

“... there is, as yet, no published description of the overall prevalence of sexual dysfunction among ziprasidone [Abilify] -treated patients in clinical practice” (p. 206).

A 2006 post-marketing surveillance review of the FDA MedWatch database revealed that Risperdal, in particular, elevates prolactin levels to dangerous levels, causing pituitary tumors and gynecomastia (breast development in boys).

"Risperidone had the highest adjusted reporting ratios for hyperprolactinemia (34.9%), galactorrhea (19.9%), and pituitary tumor (18.7%) among the seven antipsychotics, and one of the highest scores for all drugs in the AERS database.” “Some tumors were associated with visual field defects, hemorrhage, convulsions, surgery, and severe (>10-fold) prolactin elevations."    

Since 2006, the Risperdal drug label acknowledges the risk of gynecomastia in children:
"In clinical trials in 1885 children / adolescents, gynecomastia was reported in 2.3% [43]  of risperidone-treated patients." Given that adolescents are still developing sexually, exposure to drugs that increase prolactin levels, and interfere with, or arrest normal sexual development, may potentially result in chemical castration. Where are the long-term studies?

The FDA’s rush to approve expanded licensure to market antipsychotics for children should be viewed in the context of this morally reprehensible, medically unsupportable policy by the federal government.
Risperdal and Abilify were given expanded FDA licensure without even a public hearing.  Last week, an advisory committee considering expanding indications of AstraZeneca’s Seroquel, Pfizer’s Geodon, and Eli Lilly’s Zyprexa to children and adolescents avoided acknowledging the elephants in the room—as Martha Rosenberg aptly describes in her insightful report about the two-day proceedings (below).

When a panel member tried to delve into any number of embarrassing safety issues—as for example, 5 child suicides in a Seroquel trial, or Geodon-related “sudden deaths,” the panel member was swiftly led away by FDA’s own chief of psychiatric drug products, Dr. Thomas Laughren. Laughren “didn’t want to be derailed over the two children who perversely died from stroke and cardiopulmonary failure in Geodon,” when he stated that there’s “hazard in drawing too much from subsetting the data.” For his success in diverting attention from children’s drug-related deaths, Dr. Laughren was thanked by Pfizer’s representative at the hearing. 

The FDA advisory panel was not provided with any of the damaging evidence about antipsychotics’ harmful effects contained in manufacturers’ internal documents that have been uncovered during litigation. Nor were they provided with imaging evidence of brain damage caused by these drugs, nor data about their serious adverse effects on normal sexual function. The manufacturers’ determination to gain legitimacy for off-label marketing was accomplished with no one voting against pediatric approval of the three drugs despite the lethal risks for children. A handful of panelists abstained.

FDA approval of antipsychotics for pediatric use removes an obstacle that undermined the legitimacy of prescribing unapproved drugs for children under the government’s auspices.

EDIPPP is a prescription for disaster, with or without FDA’s seal of approval.
As was revealed at the advisory committee hearing, screening or diagnosing pediatric bipolar or schizophrenia is mostly wrong: of 3,000 suspected childhood schizophrenia cases recruited for a study, only 110 proved to be valid.
The implementation of EDIPPP will result in unknown numbers of children being condemned to exposure to toxic drugs, and unknown numbers to drug-induced disability, on the basis of junk science and delusional prevention theories that are grounded in eugenics—not scientific evidence.

Who will lead the way, step forward, and urge President Obama to ”Stop this travesty—it’s happening on your watch!

Who within the medical scientific community will raise their voice and use their influence to stop this travesty before it's too late?

References:
1. Baggaley M. Sexual dysfunction in schizophrenia: Focus on recent evidence. Human Psychopharmacology 2008; 23(3): 201-209.

2. Szarfman A, Tonning JM, Levine JG, Doraiswamy PM. Atypical antipsychotics and pituitary tumors: a pharmacovigilance study. Pharmacotherapy 2006; 26(6):748-58.


Posted by Vera Hassner Sharav
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US_Health_Human_Services_Document

Early Detection & Intervention for the Prevention of Psychosis Program (EDIPPP) 
Talking Points Crib Sheet
June 10, 2009

Simple Key Messages
•    EDIPPP is a treatment-research study
•    It’s goal is to stop the progression of mental illness in its tracks
•    The intervention treats symptoms of mental illness in young people before serious illness occurs.
•    It equips family members with tools to reinforce and support therapies
•    It engages the community in recognizing early warning signs
•    The results are promising for changing the system of mental health care
•    Updates on the research are provided to anyone that signs us as a ChangeMyMind supporter on EDIPPP’s Web site, ChangeMyMind.org

Program
What interventions does EDIPPP use?   
•    EDIPPP uses various combinations of the following interventions: 
o    Phone consultation
o    Assessment and engagement
o    Psycho-education
o    Multifamily groups
o    Crisis management
o    Limited individual and family counseling
o    Medication management
o    Occupational therapy
o    Supported education and employment
o    Community outreach education

How do you know this intervention works for adolescents/young adults?  Is there evidence?   
•    Numerous studies undertaken in other countries have indicated the effectiveness of this approach.  EDIPPP is the effort in the United States that is gathering the evidence for robust, replicable treatment options.

How do you monitor participant safety?
•    EDIPPP is a carefully designed research program. All the treatment components being utilized are evidence-based and EDIPPP is routinely monitored by Institutional review board (IRB) that protects the rights of participants. 

Who pays for the program?
•    EDIPPP is currently funded by the Robert Wood Johnson Foundation and has invested $16.9 Million in this promising program. 

Why doesn’t every community have an EDIPPP site?
•    As a research and treatment program, EDIPPP is following specific protocols that require specialized training and technical assistance. The opportunity for communities to replicate the EDIPPP the approach will be determined upon completion of the research.
Where do I go/send people if there is not an EDIPPP site in my community?   
•    Contact your local community mental health service provider to learn more about available services for adolescents and young adults.  Sign up as a ChangeMyMind supporter at ChangeMyMind.org to receive updates on EDIPPP research and expanded programming.

Can other communities replicate the EDIPPP approach?   
•    Not yet.  Training on the EDIPPP approach, including the technical assistance to appropriately implement the model, is in development and will be finalized as the research is completed. 

Illness
What is severe mental illness?
•    A serious disorder of the brain that includes Bipolar Disorder, Major Depression, Schizophrenia, and OCD.

What is psychosis?   
•    A mental state in which the individual loses contact with reality and may include hallucinations (hearing voices or seeing visions), delusions (false beliefs or marked suspicions of others), and/or disorganized thinking.

How many people suffer from severe mental illness?   
•    One in ten young Americans suffer from mental illness.  Approximately three percent of adolescents/young adults suffer from schizophrenia.

What are the early warning signs?
•    Before psychosis starts, warning signs may include:
o    Feeling “something’s not quite right”
o    Being fearful for no good reason
o    Hearing sounds/voices that are not there
o    Declining interest in people, activities and self-care
o    Jumbled thoughts and confusion
o    Trouble speaking clearly
   
Impact
Why is this important to me and my community?   
•    EDIPPP benefits communities by helping individuals achieve their potential and become contributing members of society.

Challenges
Isn’t this experimenting with young lives?
•    EDIPPP is a research-directed initiative, not an experimental program. Rigorous review and approval by an Institutional review board (IRB) assures that all practices are ethical, high quality, and protect the rights of participants. 

Aren’t you just promoting the use of medication?   
•    No.  Treatment recommendations are individualized and may or may not include the use of medication.  If medication is recommended, it is often used in very low doses and is strictly monitored.

Aren’t untrained professionals diagnosing someone when they make referral?
•    No.  Individuals that spend time with adolescents and young adults observe behaviors or warning signs that might or might not indicate a need for treatment.  No diagnosis is made by making a referral.  A trained EDIPPP professional will conduct a telephone consultation to determine if further action is necessary.

Won’t labeling young people with an illness make it come true?   
•    No.  The goal of this program is to avoid a diagnosis altogether - no label is given. Early intervention can mean relief from symptoms helping adolescents/young adults stay in school, maintain relationships and plan for the future.

How do you know the program isn’t treating an illness that may never develop?   
•    The purpose of treating early warning signs is to avoid a diagnosis of mental illness. 

Existing evidence applies to adults.  How do you know it works for adolescents/young adults?
•    Early diagnosis and intervention studies have shown great potential and these evidence-based approaches are being implemented to build the evidence on how to best treat adolescents and young adults at risk.
How do you justify so many resources for such a small population that is impacted?
•    The actual number of people impacted includes the individual, the family, and many different members of the community. The evidence being collected has promising implications for mental health services across the board.  

Seroquel, Zyprexa and Geodon for Kids? You Bet Says FDA Panel
by Martha Rosenberg / June 13th, 2009

ADELPHI, MD — Even as a US District Court prepares 6,000 Seroquel lawsuits for trial, Eli Lilly pays $1.42 billion for illegal Zyrexa marketing and 30 states sue over heisted Medicaid funds for atypical antipsychotics, an FDA advisory panel has recommended approval of Seroquel, Zyrexa and Geodon for children.

After two days of hearings, the FDA Psychopharmacologic Drugs Advisory Committee voted to recommend approval of AstraZeneca’s Seroquel (quetiapine) for the acute treatment of schizophrenia in adolescents 13-17, acute treatment of bipolar mania in children 10-12 and adolescents 13-17; Pfizer’s Geodon (ziprasidone) for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in children and adolescents ages 10-17; and Eli Lilly’s Zyprexa (olanzapine) for the acute treatment of manic or mixed episodes associated with bipolar I disorder and acute treatment of schizophrenia in adolescents.

Most people know pharma’s blockbuster atypical antipsychotics Seroquel, Zyprexa and Geodon, off label marketed to kids, the elderly, the uncategorizable and the suggestible –are you sure you don’t have racing thoughts ask ads?–correlate with weight gain, diabetes and metabolic derangement.

But who knew until the hearings that Seroquel also causes an extra seven or eight heart beats a minute in children? Possibly for as long as they take it? With no studies to show the long term effect? Or the safety of drugs to treat the effect? And no theory as to why?

Who knew Seroquel could cause cataracts?

Who knew Geodon could cause a prolonged QT interval also known as “sudden death.”

Who knew the atypicals, along with tremor and muscle rigidity, could cause the permanent and stigmatizing tardive dyskinesia they were developed to prevent? Hello?

Of course AstraZeneca doctor Liza O’Dowd did her best during her presentation to sail through the negatives–assuring the panel that Seroquel’s blood pressure, weight, glucose and prolactin issues could be “controlled and monitored” and that they “didn’t lead to discontinuation of the study” (let’s hope not when the trial was three weeks.)

But she was less forthcoming when discussing the five child suicides seen during trials, a slide she only produced in response to panel questions.

AstraZeneca’s Ihor Rak, MD did his best to dismiss cataract problems as “poor hygiene, nutrition and accidents” seen with schizophrenics but had no ready answer when panelist member Benedetto Vitiello, MD asked why not, then, remove instructions to examine patient lenses from the prescribing information.

AstraZeneca presenter Lili Kopala, MD was certain the study suicides stemmed from patients who were “still on the recovery curve,” but when panelist Christopher Granger, MD challenged her, she changed her mind and said, “they may be random.”

And panelists had other questions.

Not being trained psychiatrists, how did you make the differential diagnosis of bipolar for your studies asked panelist Kenneth Towbin, MD? How do you know irritability, anxiety or aggression don’t denote other disorders? How could a Seroquel study in which children with mania are kept on stimulants be scientifically valid–or ethical?

Children are often on “cocktails of seven or eight medications,” agreed Rochelle Caplan, MD, and “once we get them off,” they might just have a learning disability.

Worse than problems diagnosing pediatric bipolar or schizophrenia–3,000 suspected childhood schizophrenia cases yielded only 110 actual cases in one study said panelist Nitin Gogtay, MD–and worse than the lack of “real world” and mixed medicine “cocktail” studies was the brevity of the studies themselves said panelists.

How can three and six week studies suggest safety for maintenance treatment of schizophrenia and bipolar disorders which lasts decades? “We know they won’t stop [using the medications] at the acute phase,” said Towbin.

Panelist Granger confessed to “real discomfort” approving drugs which “generat[e] metabolic syndrome in adolescents in a very short period of time” for “indefinite use” on the basis of three or six week trials. “Hopefully we’re not exposing someone for decades,” agreed fellow cardiologist Edward Pritchett, MD.

But Thomas Laughren, MD, FDA’s director of psychiatric drugs was more upbeat. Not only was he sure pediatric safety could be extrapolated from adult studies–promising to include the clinical leap on labels–he didn’t want to be derailed over the two children who perversely died from stroke and cardiopulmonary failure in Geodon studies either.

There’s “hazard in drawing too much from subsetting the data,” said Laughren. Phillip Chappell, MD of Pfizer thanked him.

Frank Greenway, MD, an endocrine specialist on the panel, was also upbeat, observing prolactin elevation from the atypicals was less than a “prolactin secreting tumor.” Whew.

Still the elephant in the room at the proceedings was why drugs that are already available off-label need FDA approval at all–and why it’s urgent that kids showing symptoms be Treated Now.

(One pharma doctor claimed gray matter shrinks ever time someone is “psychotic” but others admitted early treatment has no effect on the course of the diseases.)

The answer of course was in the other elephant in the room–the wall of 40 pharma funded doctors sitting at attention, outnumbering FDA representatives two to one and unabashed referred as “sponsors.” (Though their Medicaid streams imply that’s backwards.)

It’s the sponsors who exhort doctors–and parents–to subject kids to increased heart beat, sudden death, metabolic syndrome, tardive dyskinesia, cataracts, stroke and suicidal side effects for diseases they may not even have.

Certainly that’s how two mothers who testified during the open public hearings felt.

Liza Ortiz of Austin, TX lost her 13-year-old son to Seroquel toxicity earlier this year. “His hands twisted in ways I never thought possible in the I.C.U., ” she said.

Mary Kitchens of Bandera, TX said her son suffers from crossed eyes, nightmares, trembling, neutropenia, hypothyroidism, tachycardia, dyskinesia and cogwheeling since Seroquel treatment.

“AstraZeneca marketed this to my child in 2003,” she said holding the original Seroquel package for the panel to see. “And now they want your seal of approval.”

Martha Rosenberg is a columnist/cartoonist who writes about public health. She can be reached at: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it <mailto: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it >.