The author's relevant Conflicts of Interest none:
I am biased. My son is a Risperdal victim. J& J started illegally marketing the drug as soon as it was FDA approved. All due respect to the Justice Department, the investigation going back to 2004, is not going back far enough. J&J had been illegally marketing Risperdal for close to a decade by 2004. The DOJ fines and penalties that amount to a very small % of the money that J&J defrauded from the American people has done absolutely nothing to alter the manner in which business is conducted. More importantly, it does absolutely NOTHING to compensate J&J's PRIMARY VICTIMS who are grievously harmed, and disabled. It does NOTHING for those who mourn the loss of a family member, the parents and children of J&J's victims who were killed by iatrogenic homicide, the victims who were further victimized as a result of the adverse effects of Risperdal by unethical professionals who attributed the adverse effects to the patient's "psychiatric disease," or the parents who are taking care of their adult children who are disabled by drugs.
a screen shot from Sheller FDA Petition Comments
I am getting real tired of the "news reports" in the mainstream media which are about risk for diabetes and obesity from the neuroleptic drugs, called "antipsychotics." Children are being prescribed neuroleptic drugs for virtually any and every diagnosis---this is clearly Human Experimentation, occurring in Standard Clinical Practice; referring to it as "off label prescribing" implies that that there is some statistically relevant evidence which supports using these teratogenic drugs with fatal risks in the manner they are being used. The evidence does not even support using the drugs for the diagnosis of schizophrenia; the condition for which the drugs were originally developed and prescribed for.
The very real risks of obesity and diabetes however are not, at least in my mind, what is most alarming about the fact that so many children are being prescribed neuroleptic drugs; nor is the fact that the American people are being defrauded through Medicaid (still!) in order to pay for these "off label" prescriptions over 90% of the time. Nor is it that journalists are failing to ethically report on any of the issues involved with prescription drugs, with rare exceptions being too few and often lost amongst the prescription drug advertising and press releases journalists publish without verifying the veracity of any of the "facts" which the press releases contain...I accept that this is what is passes for "reporting the news" about psychiatric research, and the teratogenic drugs which are used to treat psychiatric diagnoses. Very little reporting about the rampant academic research fraud; even less about the questionable (to say the very least) FDA approval process which puts dangerous drugs on the market, and Americans at risk. The FDA approval process is often followed by an utter lack of compliance with after-market testing requirements with no penalties; the same for the false claims made in direct-to-consumer and direct-to-professional marketing campaigns. That people are being harmed at an alarming rate is "not news" and the fact that all of this is due to the unethical conduct of public servants who have glaring Conflicts of Interest is also unreported by mainstream journalists.
Add to this obfuscation of the facts about psychiatric diagnoses and the toxic teratogens drugs used to "treat" them, the fact that adverse effects (including death) do not have to be reported to the FDA--If it were the FDA's primary purpose to protect people from the risks of prescription drugs, adverse events and adverse effects including death, is data that needs to be collected in order to effectively assess a drug's safety profile. However it is plain to me that the FDA does not serve the American people, so it is purposely not doing the things which would protect the American people that it would need to do, if protecting patients were in fact it's primary purpose. It is only it's stated purpose; and I do not believe that this stated purpose was ever anything but a cover story. I don't believe it was ever the FDA's primary purpose; in any case, it certainly is not the purpose it effectively or ethically serves today.
The primary purpose served by the modern FDA is to protect the interests of the pharmaceutical industry. It is obvious that people who are given a psychiatric diagnosis are automatically at risk for experiencing grave harm, due to the manner in which psychiatry automatically stigmatizes those it arbitrarily assigns a psychiatric diagnosis. When diagnostic criteria are determined and treatment standards developed, consensus is often substituted for scientific evidence. There are two reasons for this, the first is consensus is used when there is insufficient evidence, and the other is when the evidence does not support the consensus of "professional opinion." This is done by ignoring ethical scientific standards; and it is abdicating the responsibility to exercise sound ethical medical judgement. It is a systematic way to standardize Human Experimentation on people who are given a psychiatric diagnosis; then claim that using the unethically developed "Standards of Care" as a way to abdicate the professional from any and all legal liability. Calling it a Standard of Care when it ignores ethical scientific and medical standards is such utter BS---no one can possibly believe that just because they're doctors that all of this deception, fraud, and unethical behavior is required to provide "necessary medical treatment." It is a way way to rationalize and justify their unethical behavior; and it is an attempt to absolve "professional" individuals for the grievous harm they inflict on patients.
In standard clinical mental health practice, there is no empirical data that is used to objectively diagnose a person. More often than not, there is no evidence that would support the recommended treatment. The treatment is usually teratogenic drugs with fatal risks, and/or electroshock. The reality is there is very little science and a whole lot of consensus. Consensus is evidence of agreement; it is not evidence of diagnostic validity; it is not an ethical basis for a medical treatment, much less a basis to force a person, since it does have the serious risks of causing disability and death! Patients are at a serious disadvantage, as soon as a psychiatric diagnosis is attached. Rarely is the harm done to them reported. In my experience, as the mother of a child who was the victim of a violent assault, once a psychiatric diagnosis was attached, the harm done to my son, including felony crimes committed by "professionals," can be reported; but are never investigated.
Adverse reactions from drugs, (if even recognized as an adverse reaction) are attributed to the psychiatric "disease" the patient is diagnosed with. The way the mental health psychiatric system is set up, the direct adverse effect of diagnosis and treatment upon the patient is not relevant; negative effects are rarely acknowledged, if at all. These effects are purposely not being collected; consequently the harm cannot be quantified by those with an ethical duty to do so. Indeed, the people who have an ethical and a legal duty to, "First, do no harm..." are covering up the evidence that they are doing a great deal of harm to a great number of victims whom they call patients. The majority of these victims are poor children and foster children on Medicaid, the elderly on Medicare, and traumatized Veterans on Tri-Care. They all have one thing in common: they were seen as a means to an end. Their psychiatric stigmatization was the means and meeting the marketing goals of the pharmaceutical industry was the financially lucrative ends. these particular populations were targeted for diagnosis and treatment because they had medical benefits which would pay the costs of their "care." They were used because the American people had seen fit to ensure these vulnerable people had their medical needs provided for. Pharma's illegal marketing campaigns targeted those among us who are the most vulnerable, and least capable of effectively defending themselves to meet their marketing goals...Isn't that special?
Back to my original point, the things that are NOT being discussed are the serious adverse effects on sexual functioning that Risperdal and other psychotropic drugs have on human beings. We are allowing children who are not sexually mature, to be given drugs which adversely effect normal sexual development and functioning; in effect, ensuring that many will never be capable of having a normal sexual relationship. If that is not a risk which should be discussed of concern to their parents and the professionals who are alarmed about the diabetes and obesity risk, than I am Mary freaking Poppins! The rate children are being disabled and killed is not even MENTIONED by any of the "stake-holders" involved in the frantic efforts undertaken (supposedly on the behalf of foster children) when the THIRD Senate investigation was launched into the off label prescribing of teratogenic drugs to vulnerable children. The very people who we entrust to take care of our Nation's foster children do not appear to be concerned at all about how many of the children have been disabled and killed due to the direct negative effects of off label prescriptions taken as directed. These are relevant facts which should be part of the discussion; however, they are in fact being ignored by the paid public servants in Child Welfare, Academic Researchers paid to do drug and psychiatric treatment research, grassroots advocates claiming to be the Nation's voice on mental illness, The American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry.
Well I am WIDE awake and I want to know why are the worst risks faced by these children for brain damage, sexual development, and sexual dysfunction, sudden death, and chronic neurological impairment are being ignored by those who are "concerned." The study below is over; as usual, results are not available...
But more than this, I want to know who is the idiot who thought putting active participants in an ongoing criminal enterprise, in charge of protecting their victims was a good idea?
Clinical Trials.gov
An Observational Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
This study has been completed.
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01050582
First received: January 14, 2010
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
Purpose
The purpose of this observational study is to evaluate risk of prolactin-related adverse events (side effects) and the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children exposed to these drugs
Condition
Intervention
Phase
Schizophrenia
Bipolar Disorder
Autistic Disorder
Attention Deficit and Disruptive Behavior Disorders
Drug: Risperidone
Drug: Other atypical antipsychotic drugs
Phase 4
Study Type:
Interventional
Official Title:
Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs
Resource links provided by NLM:
MedlinePlus related topics: Autism Bipolar Disorder Schizophrenia
Drug Information available for: Prolactin Risperidone
U.S. FDA Resources
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
To compare Z-scores for height, age at current Tanner stage, and prolactin-related adverse events between patients exposed to risperidone and patients exposed to other atypical antipsychotic drugs. [ Time Frame: During the study visit and retrospectively during the time of exposure for up to 2 years prior to the study visit ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Assess the prolactin value and risk of hyperprolactinemia associated with risperidone as compared with other atypical antipsychotic medications in a pediatric population. [ Time Frame: One time during the study visit ] [ Designated as safety issue: Yes ]
Identification of subgroups of patients at high risk for changes in height or maturation. [ Time Frame: During the study visit and retrospectively during the time of exposure for up to 2 years prior to the study visit ] [ Designated as safety issue: No ]
Enrollment:
244
Study Start Date:
October 2009
Study Completion Date:
July 2011
Primary Completion Date:
July 2011 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
No Intervention: 001
Risperidone As per local prescribing practices
Drug: Risperidone
As per local prescribing practices
No Intervention: 002
Other atypical antipsychotic drugs As per local prescribing practices
Drug: Other atypical antipsychotic drugs
As per local prescribing practices
Show Detailed Description
Eligibility
Ages Eligible for Study:
8 Years to 16 Years
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
One or both parents (according to local regulations) or a guardian must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study (If appropriate according to local regulations, the patient must also assent)
Treated for schizophrenia, bipolar mania, autistic disorder, or conduct and other disruptive behavior disorders
Had at least 6 months of exposure for an atypical antipsychotic drug within 24 months before the study visit (patients may or may not be taking the atypical antipsychotics at the time of actual enrollment, eligible patients can have exposure to multiple atypical antipsychotics, however, they cannot concomitantly be exposed to more than 1 atypical antipsychotic for a period of greater than 30 days)
Had medical records or automated data available for at least 1 year prior to the start of exposure
Height and weight were recorded at least once within 1 year before the start of exposure, and if available at any time points after the start of exposure in the medical records or electronic databases (not mandatory)
Exclusion Criteria:
Have at least 1 medical record, at any time before the start of exposure, consistent with malignancy (other than non-melanoma skin cancer), pregnancy, or a developmental delay or abnormality associated with growth or sexual maturation delays not related to the specified indications
Had exposure to prolactin elevating medications other than atypical antipsychotics and selective serotonin reuptake inhibitors (SSRIs)
Had exposure to Paliperidone
Cannot comply with study procedures
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050582
Hide Study Locations
Locations
United States, California
San Francisco, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Florida
Altamonte Springs, Florida, United States
Gainesville, Florida, United States
United States, Georgia
Smyrna, Georgia, United States
United States, Illinois
Naperville, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
Valparaiso, Indiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
Cambridge, Massachusetts, United States
United States, New York
Glen Oaks, New York, United States
United States, Ohio
Cleveland, Ohio, United States
Columbus, Ohio, United States
Belgium
Antwerpen, Belgium
Germany
Freiburg, Germany
Jena, Germany
Mannheim, Germany
München, Germany
Tübingen, Germany
Ulm, Germany
Würzburg, Germany
Greece
Athens, Greece
Netherlands
Nijmegen, Netherlands
Poland
Gdansk, Poland
Kielce, Poland
Lódź, Poland
Sosnowiec, Poland
Warszawa, Poland
Warszawa N/A, Poland
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director:
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information
No publications provided
Responsible Party:
Clinical Leader Psychiatry, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01050582 History of Changes
Other Study ID Numbers:
CR016687
Study First Received:
January 14, 2010
Last Updated:
May 25, 2012
Health Authority:
United States: Institutional Review Board
United States: Food and Drug Administration
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia
Bipolar Disorder
Autistic Disorder
Attention Deficit and Disruptive Behavior Disorders
Risperidone
RISPERDAL
Antipsychotic Agents
Prolactin
Pediatrics
Additional relevant MeSH terms:
Schizophrenia
Child Development Disorders, Pervasive
Schizophrenia and Disorders with Psychotic Features
Autistic Disorder
Mental Disorders
Bipolar Disorder
Attention Deficit and Disruptive Behavior Disorders
Attention Deficit Disorder with Hyperactivity
Mental Disorders Diagnosed in Childhood
Affective Disorders, Psychotic
Mood Disorders
Antipsychotic Agents
Risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
ClinicalTrials.gov processed this record on October 03, 2012