Cipramil advertisement, 2001
He got lost and fell asleep in the woods. Now he has the head of an ass and the queen of the fairies wants to marry him. The last thing he needs is more complications.
Do you dream of an uncomplicated antidepressant? Chances are you're dreaming of Cipramil. It's effective, well tolerated and associated with a low risk of drug interactions. In other words, Cipramil helps to make treating depression or panic disorder less of a performance. CIPRAMIL citalopram
Antidepression not antipatient Lundbeck
"Watch out for people who begin with another's concern to end with their own." Balthasar Gracian
"Not only did the DSM become the bible of psychiatry, but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions. That is an astonishing omission, because in all medical publications, whether journal articles or textbooks, statements of fact are supposed to be supported by citations of published scientific studies."
Marcia Angell, M.D. in the NYT Review of Books
via the American Academy of Child and Adolescent Psychiatry:
Prescribing Psychoactive Medication for Children and Adolescents
Revised and approved by the Council on September 20, 2001
Prescribing psychoactive medications for children and adolescents requires the judgement of a physician, such as a child and adolescent psychiatrist, with training and qualifications in the use of these medications in this age group. Certainly any consideration of such medication in a child or infant below the age of five should be very carefully evaluated by a clinician with special training and experience with this very young age group. Any child or adolescent for whom medication is a consideration requires an evaluation of the psychiatric disorder, including the symptoms, co-morbid conditions, any other medical conditions, family and psychosocial assessment and school record.
Most psychoactive medications prescribed for children under age 12 do not as yet have specific approval by the Federal Drug Administration (FDA); such approval requires research demonstration safety and efficacy. Such research, so far, lags behind the clinical use of these medications. Efforts to address this deficiency include the development of Research Units of Pediatric Psychopharmacology (RUPP) and recent federal regulations requiring increased studies of medications presented for children and adolescents. Long term studies are needed to adequately determine the safety and efficacy of psychoactive medications. In making decisions to prescribe such medications the physician - specifically the child and adolescent psychiatrist - should consider data from studies in adults in treating the target disorder and/or symptomatology, any clinical or anecdotal reports of use in child and adolescent patients, studies conducted outside the United States and the experience of colleagues.
Anecdotally the prescribing of multiple psychotropic medications ("combined treatment"- "polypharmacy") in the pediatric population seems on the increase. Little data exist to support advantageous efficacy for drug combinations, used primarily to treat co-morbid conditions. The current clinical " state-of-the-art" supports judicious use of combined medications, keeping such use to clearly justifiable circumstances. Medication management requires the informed consent of the parents or legal guardians and must address benefits vs. risks, side effects and the potential for drug interactions.
It is important to balance the increasing market pressures for efficiency in psychiatric treatment with the need for sufficient time to thoughtfully, correctly, and adequately, assess the need for, and the response to medication treatment. Monitoring on-going use of psychoactive medications requires sufficient time to assess clinical response, side effects and to answer questions of the child and family. AACAP opposes the use of brief medication visits (e.g. 15-minute medication checks) as substitute for ongoing individualized treatment. The role of psychosocial interventions, including psychotherapy, must be evaluated, and such interventions must be included in the treatment plan.
This is a Policy Statement of the American Academy of Child and Adolescent Psychiatry found here
More from Marcia Angell via NYT Review of Books:
"The original purpose of permitting doctors to prescribe drugs off-label was to enable them to treat patients on the basis of early scientific reports, without having to wait for FDA approval. But that sensible rationale has become a marketing tool. Because of the subjective nature of psychiatric diagnosis, the ease with which diagnostic boundaries can be expanded, the seriousness of the side effects of psychoactive drugs, and the pervasive influence of their manufacturers, I believe doctors should be prohibited from prescribing psychoactive drugs off-label, just as companies are prohibited from marketing them off-label."
THANK YOU Dr. Angell! As noted in the above AACAP Policy, from a decade ago, " Most psychoactive medications prescribed for children under age 12 do not as yet have specific approval by the Federal Drug Administration (FDA); such approval requires research demonstration safety and efficacy." In effect, and in fact, this means 'off-label' prescriptions of these teratogens are not only not studied for safety in children, neither are the long-term effects of their use in children singly or used in combination, studied or documented.
It is more than apparent to me that the indiscriminate drugging of children with psychotropic drugs is driven by commercial interests; medical ethics require that treatment decisions be made with the primary purpose to serve the "Best Interests" of the patient. Children on Medicaid have in effect, become research fodder and a means to meet marketing goals. These children have been, and continue to be 'treated' with a single, or a combination of teratogenic drugs experimentally; many, if not most, of the prescriptions have no definitive empirical support in the 'Evidence Base;' the drugs have not been tested or approved for children, or for the reason they are prescribed...
What I find most alarming about all of this, is that the 'doctors' who are members of the AACAP and the APA have convinced themselves that it is ethical to recommend in the absence of FDA approval numerous neurotoxic psychiatric drugs for use in children at all. (singularly or in combination with other psychiatric drugs called 'polypharmacy') This is what is passing for sound medical judgement! It is not sound, it is not evidence-based and it is not an ethical medical practice! Indeed, many of the treatment protocols and algorithms used in Standard Practice are contradictory to reasonable conclusions drawn from the empirical data that does exist. These protocols and algorithms serve to propel the ongoing widespread use of dangerous drugs off-label; basically using patients as unwitting guinea pigs in Clinical Practice.
These pseudo-scientific standards are also used as justification for removing children from their homes and families and in other adjudicatory proceedings as if they were based in scientific evidence diligently and ethically collected and reported. In reality, most of the Treatment Algorithms, Practice Parameters, and the Diagnostic Criteria (DSM) used in Standard Practice is derived from objective opinions, which are then 'validated' by consensus when members of the AACAP and APA membership VOTE them into existence. This is not a scientific process; it is a quasi-democratic process. A consensus of subjective opinions is evidence of agreement, and that is what forms the foundation of bio-psychiatry. So pretending it is evidence-based is ludicrous it cannot even rightfully claim to be an ethical medical specialty, as it is not based on ethical scientific standards which is a requirement for ethical evidence based medical research and clinical practice. A consensus of even educated subjective opinions is evidence only of agreement. Consensus is not a replacement for actual empirical data demonstrating diagnostic validity. Using consensus as the primary support for treatment protocols, algorithms and parameters to treat diagnoses which are based on the consensus is precisely why psychiatry is considered 'less than.'
"At the very least, we need to stop thinking of psychoactive drugs as the best, and often the only, treatment for mental illness or emotional distress. Both psychotherapy and exercise have been shown to be as effective as drugs for depression, and their effects are longer-lasting, but unfortunately, there is no industry to push these alternatives and Americans have come to believe that pills must be more potent. More research is needed to study alternatives to psychoactive drugs, and the results should be included in medical education."
"In particular, we need to rethink the care of troubled children. Here the problem is often troubled families in troubled circumstances. Treatment directed at these environmental conditions—such as one-on-one tutoring to help parents cope or after-school centers for the children—should be studied and compared with drug the treatment." As Dr. Angell pointed out in her response to criticism of her Review in NYT Reveiw of Books in 2009 in reference to the testing of psychiatric drugs on children in clinical trials: "Many have been tested and found not to warrant FDA approval; others have been tested in poorly designed trials for marketing purposes, not to gain FDA approval. Although it is illegal to promote drugs for use in children if the FDA has not approved them for that use, the law is frequently circumvented by disguising marketing as education or research. Eli Lilly recently agreed to pay $1.4 billion to settle civil and criminal charges of marketing the anti-psychotic drug Zyprexa for uses not approved by the FDA (known as “off-label” uses). Zyprexa, which has serious side effects, is one of the drugs frequently used off-label to treat children diagnosed with bipolar disorder. I don’t deny the serious effects of psychiatric conditions, but it is still necessary to show in adequate clinical trials that the drugs used to treat them do more good than harm." Read ‘Drug Companies & Doctors’: An Exchange here
The AACAP is concerned with balancing, "the increasing market pressures for efficiency in psychiatric treatment with the need for sufficient time to thoughtfully, correctly, and adequately, assess the need for, and the response to medication treatment." This balancing act is not what I would consider in the best interests of the patient as efficiency cannot be substituted for efficacy and safety; and sound ethical medical judgement is missing altogether...
It is important to balance the increasing market pressures for efficiency in psychiatric treatment with the need for sufficient time to thoughtfully, correctly, and adequately, assess the need for, and the response to medication treatment. Monitoring on-going use of psychoactive medications requires sufficient time to assess clinical response, side effects and to answer questions of the child and family. AACAP opposes the use of brief medication visits (e.g. 15-minute medication checks) as substitute for ongoing individualized treatment. The role of psychosocial interventions, including psychotherapy, must be evaluated, and such interventions must be included in the treatment plan.
This is a Policy Statement of the American Academy of Child and Adolescent Psychiatry found here
More from Marcia Angell via NYT Review of Books:
"The original purpose of permitting doctors to prescribe drugs off-label was to enable them to treat patients on the basis of early scientific reports, without having to wait for FDA approval. But that sensible rationale has become a marketing tool. Because of the subjective nature of psychiatric diagnosis, the ease with which diagnostic boundaries can be expanded, the seriousness of the side effects of psychoactive drugs, and the pervasive influence of their manufacturers, I believe doctors should be prohibited from prescribing psychoactive drugs off-label, just as companies are prohibited from marketing them off-label."
THANK YOU Dr. Angell! As noted in the above AACAP Policy, from a decade ago, " Most psychoactive medications prescribed for children under age 12 do not as yet have specific approval by the Federal Drug Administration (FDA); such approval requires research demonstration safety and efficacy." In effect, and in fact, this means 'off-label' prescriptions of these teratogens are not only not studied for safety in children, neither are the long-term effects of their use in children singly or used in combination, studied or documented.
It is more than apparent to me that the indiscriminate drugging of children with psychotropic drugs is driven by commercial interests; medical ethics require that treatment decisions be made with the primary purpose to serve the "Best Interests" of the patient. Children on Medicaid have in effect, become research fodder and a means to meet marketing goals. These children have been, and continue to be 'treated' with a single, or a combination of teratogenic drugs experimentally; many, if not most, of the prescriptions have no definitive empirical support in the 'Evidence Base;' the drugs have not been tested or approved for children, or for the reason they are prescribed...
This is not ethical medical care.
It is human experimentation on poor children.
It is human experimentation on poor children.
What I find most alarming about all of this, is that the 'doctors' who are members of the AACAP and the APA have convinced themselves that it is ethical to recommend in the absence of FDA approval numerous neurotoxic psychiatric drugs for use in children at all. (singularly or in combination with other psychiatric drugs called 'polypharmacy') This is what is passing for sound medical judgement! It is not sound, it is not evidence-based and it is not an ethical medical practice! Indeed, many of the treatment protocols and algorithms used in Standard Practice are contradictory to reasonable conclusions drawn from the empirical data that does exist. These protocols and algorithms serve to propel the ongoing widespread use of dangerous drugs off-label; basically using patients as unwitting guinea pigs in Clinical Practice.
These pseudo-scientific standards are also used as justification for removing children from their homes and families and in other adjudicatory proceedings as if they were based in scientific evidence diligently and ethically collected and reported. In reality, most of the Treatment Algorithms, Practice Parameters, and the Diagnostic Criteria (DSM) used in Standard Practice is derived from objective opinions, which are then 'validated' by consensus when members of the AACAP and APA membership VOTE them into existence. This is not a scientific process; it is a quasi-democratic process. A consensus of subjective opinions is evidence of agreement, and that is what forms the foundation of bio-psychiatry. So pretending it is evidence-based is ludicrous it cannot even rightfully claim to be an ethical medical specialty, as it is not based on ethical scientific standards which is a requirement for ethical evidence based medical research and clinical practice. A consensus of even educated subjective opinions is evidence only of agreement. Consensus is not a replacement for actual empirical data demonstrating diagnostic validity. Using consensus as the primary support for treatment protocols, algorithms and parameters to treat diagnoses which are based on the consensus is precisely why psychiatry is considered 'less than.'
It is less than scientific,
it is less than ethical,
and it is less than honest to pretend otherwise.
Much of the pseudo-scientific 'research and development;' in particular, the work which went into the development of treatment algorithms and protocols adopted by State Medicaid programs, and used to formulate preferred drug lists and public health policy, was conducted by members of the AACAP and the APA. This 'work product' now serves as a critical component of the massive ongoing Medicaid fraud. The primary beneficiaries of these National Leaders in Psychiatric Research who were funded by the American people, but also by the drug industry, are the Pharmaceutical Companies. The membership of the APA and the AACAP who validated the diagnoses and treatments by a vote; formally adopting them as "Standard Practices" to be used in clinical practice, unwittingly or not, intentionally or not, have played a role in defrauding the American people of billions of dollars while causing iatrogenic diseases and iatrogenic homicide. It is a delusional construct which resembles ethical medical practice not at all...I call it delusional psychiatric medicine. It is obviously unethical given the reality of the massive fraud, corruption and subterfuge underlying the development and adoption of it's Standard Clinical Practices. It is being vehemently defended by some; criticized and impugned by others.
The unvarnished truth which confronts us today:
As a society, we have allowed poor children to be exploited.
More from Marcia Angell: "At the very least, we need to stop thinking of psychoactive drugs as the best, and often the only, treatment for mental illness or emotional distress. Both psychotherapy and exercise have been shown to be as effective as drugs for depression, and their effects are longer-lasting, but unfortunately, there is no industry to push these alternatives and Americans have come to believe that pills must be more potent. More research is needed to study alternatives to psychoactive drugs, and the results should be included in medical education."
"In particular, we need to rethink the care of troubled children. Here the problem is often troubled families in troubled circumstances. Treatment directed at these environmental conditions—such as one-on-one tutoring to help parents cope or after-school centers for the children—should be studied and compared with drug the treatment." As Dr. Angell pointed out in her response to criticism of her Review in NYT Reveiw of Books in 2009 in reference to the testing of psychiatric drugs on children in clinical trials: "Many have been tested and found not to warrant FDA approval; others have been tested in poorly designed trials for marketing purposes, not to gain FDA approval. Although it is illegal to promote drugs for use in children if the FDA has not approved them for that use, the law is frequently circumvented by disguising marketing as education or research. Eli Lilly recently agreed to pay $1.4 billion to settle civil and criminal charges of marketing the anti-psychotic drug Zyprexa for uses not approved by the FDA (known as “off-label” uses). Zyprexa, which has serious side effects, is one of the drugs frequently used off-label to treat children diagnosed with bipolar disorder. I don’t deny the serious effects of psychiatric conditions, but it is still necessary to show in adequate clinical trials that the drugs used to treat them do more good than harm." Read ‘Drug Companies & Doctors’: An Exchange here
The AACAP is concerned with balancing, "the increasing market pressures for efficiency in psychiatric treatment with the need for sufficient time to thoughtfully, correctly, and adequately, assess the need for, and the response to medication treatment." This balancing act is not what I would consider in the best interests of the patient as efficiency cannot be substituted for efficacy and safety; and sound ethical medical judgement is missing altogether...
"Whenever a doctor can not do good, he must be kept from doing harm." Hippocrates
Ritalin advertisement
Mental Hospitals, March 1957
you can bring patients "out of the corner"
with RITALIN® hydrochloride (methylphenidate hydrochloride CIBA) provides needed stimulation... without euphoria or depressive rebound Ritalin has proved effective in awakening patients to reality, even in "severe deteriorated chronic schizophrenia of long standing."(1) The most responsive patients to Ritalin appear to be the true depressives (negative, withdrawn, dull, listless, apathetic) -- without correlation to age or length of hospitalization.(2)
On 10 to 40 mg. Ritalin t.i.d., such patients become more amenable to therapy, suggestion, and social participation.(2)
1. Leake, C.D.: Ohio M.J. 52:369 (April) 1956. 2 Ferguson, J.T.: Ann. New York Acad. Sc. 61:101 (April 15) 1955. CIBA Summit, N.J.
Directives for Human Experimentation
NUREMBERG CODE
- The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. - The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
- The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
- The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
- No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
- The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
- Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
- The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
- During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
- During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182.. Washington, D.C.: U.S. Government Printing Office, 1949.
retro advertisements via bonkersinstitute.org
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