Eugenics All Over Again in 2009
http://www.ahrp.org/cms/content/view/608/107/ - from Alliance for Human Research Protection
is another scary and great article. Please go read the entire article and be as dumbfounded and concerned as I am.
Alliance for Human Research Protection
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 pharmacopeia in children.
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.
another article of importance:
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: firstname.lastname@example.org. Read other articles by Martha.