Posted: Tue Jun 16, 2009 2:29 pm
US Gov. Mental Screens / Preemptive Interventions = Eugenics All Over Again
Sunday, 14 June 2009
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.
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
link
-
Sunday, 14 June 2009
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.
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
link
-
I've got a serious circadian rhythm disorder and all the problems that come with that, a chronic acute lower back pain that really slows me down, and a family history of the usual killjoy diseases - some cancer, diabetes, heart disease... oh and I've really come around to identifying with bipolar disorder, but I don't think I'll ever unlock /that/ door to my mind for a stranger to walk through- for that, I'm grateful for having a few good understanding friends and loved ones.
