Medical treatment in which drugs are used in ways that are not FDA approved, and not supported with definitive evidence of the drugs' effectiveness or safety is accurately described as "experimental use" of the drugs; not something that should be considered a "standard clinical practice!" Atypical antipsychotics or "Second Generation Antipsychotics," are neuroleptic drugs which alter many physiological processes. Although some of this class of psychotropic drugs have been FDA approved for pediatric use, for specific psychiatric diagnoses and/or behavioral symptoms, the approval was not based on what a reasonable person would consider to be robust data of safety or efficacy, much less effectiveness. The fact is, in real world practice, neuroleptics are prescribed to kids much more off label than they are prescribed for FDA approved conditions or symptoms. In effect, experimental use of teratogenic drugs on children and youth, i.e. human experimentation, is now a "standard practice" in psychiatry.
When children and youth are prescribed psychotropic drugs off label, particularly neuroleptics, what protection do they have from harm? In effect, they have little to none; using a "standard of care" is an affirmative defense against a malpractice claim for damages, whether it is an ethical standard or not...It is unconscionable that most of the prescriptions for neuroleptic drugs are for off label use; why is this ethically questionable standard of care casually accepted by the wider medical community? Drugs that have not been tested and clinically demonstrated to be safe and effective for children and youth, should not be widely prescribed in standard practice! Nonetheless, off label prescriptions for neuroleptic drugs continue to account for the largest percentage of prescriptions for neuroleptics in the pediatric population. Neuroleptic drugs cause a wide variety of adverse cognitive effects, i.e. brain damage, neurological impairments and metabolic dysfunction; they cause diseases---these are direct, adverse effects of neuroleptic drugs, it is how they "work." This "standard practice" has been investigated by the U.S. Senate at least three times in my memory, each investigation has quantified an increase in the numbers of children being prescribed teratogenic drugs and fraudulent Medicaid claims being paid. What is not quantified is the number of children who are disabled and killed. Using poor children on Medicaid who have behavioral and emotional problems as unwitting guinea pigs is now considered an ethical standard of care...
The standards of care, treatment algorithms, and practice parameters were developed by consensus, a quasi-democratic political process, not derived from clinical research data. Psychiatric professionals who are members of the American Academy of Child and Adolescent Psychiatry, and the American Psychiatric Association, then disseminated these unethical standards in their professional literature, in symposiums and continuing medical education programs. Psychiatrists in the AACAP really would like the NIMH to fund research to hopefully gather the supporting evidence that will validate the standards of care in widespread use (thanks to the AACAP). These are the standards of care that the AACAP is simultaneously vehemently defending as "necessary medical treatment;" implying it is ethical evidence-based treatment...
The AACAP is acknowledging that the evidence for the ethical medical prescription of teratogenic drugs off label to children and youth is STILL needed---decades after the AACAP started using neuroleptic and other psychotropic drugs off label to "treat" the emotional and behavioral problems children have---decades after it became a "standard prectice." The AACAP implemented a standard of care absent the evidence required to validate it as a standard. It is not ethically possible to implement the use of psychiatric drugs "off label," i.e. experimentally, as a standard treatment without definitive evidence of safety and effectiveness. Obviously, this standard was implemented precipitously; without regard for patient safety. It is a standard of care that is not based on sound scientific principles, or actual evidence; it is absent the use of ethical medical judgement altogether...
Off label prescription drugs that are unsupported by evidence that the treatment is safe and effective, is experimental by definition. Medicaid, in theory, functions like insurance for the poor. Why are fraudulent claims for non-covered, non-approved off label prescriptions drug costs paid? It is only psychiatric drugs that are ALWAYS paid for without question, by the Medicaid program.
Billions of taxpayer dollars have been defrauded from the American people since the vast majority of off label psychotropic drugs prescribed are written for poor children on Medicaid. We pay for it even though it is not ethical, even though it is fraudulent, even though it disables and kills children.
A few months ago, the AACAP applauded the AMA for seeking guidance from the NIMH about the off label use of neuroleptics for children and youth with emotional and behavioral problems.
via the AACAP:
The American Academy of Child and Adolescent Psychiatry (AACAP) applauds the American Medical Association (AMA) for adopting a report recommending the National Institute of Mental Health (NIMH) assist in developing guidance for physicians on the use of atypical antipsychotic medications in pediatric patients, and encouraging ongoing federally funded studies on long-term efficacy and safety.
AACAP delegate to the AMA and member of the AMA Council on Science and Public Health, Louis Kraus, M.D., testified that the report discusses the complex issues surrounding the clinical use of these drugs and evaluates the data currently available.
There has been an increased use in atypical antipsychotic medications which when used appropriately can be an effective part of a comprehensive treatment plan for children with schizophrenia and bipolar disorder. However, these medications are increasingly being used "off label" when treating children and adolescents with other psychiatric disorders.
"Physicians and parents need more information about both the safety and efficacy of these medications, especially when they are used over an extended period of time," testified David Fassler, M.D., AACAP alternate delegate to the AMA.
Most research on the use of atypical antipsychotic medications on the pediatric population focuses on short term use, yet in clinical practice an increasing number of pediatric patients take these medications for many months or years.
"AACAP is pleased that the AMA is encouraging NIMH to conduct additional studies on these medications. We need to better understand both the short term and long term effects on our patients," said AACAP President, Martin J. Drell, M.D.
The AMA report is supported by the American Psychiatric Association, American Academy of Psychiatry and the Law and the American Pediatric Association. here
Does the AACAP have an ethical, medical rationale
for prescribing neuroleptics to kids off label?
No, it does not.
No, it does not.
via REPORT OF THE COUNCIL ON SCIENCE AND PUBLIC HEALTH CSAPH Report 1-I-12:
a couple excerpts:
"The proportional use of atypical antipsychotics was 16% of treatment visits in 1995, but such use had surged to 93% of treatment visits by 2008. In two-thirds of these visits, the prescription was for an off-label use.5
"Antipsychotic treatment rates among privately insured youth ages 6 to 17 increased steadily from 1996 (0.21%) to 2006 (0.90%) with higher rates among those ages 13 to 17.7 The annualized rate of use in such patients ages 2 to 5 more than doubled between 1999 and 2007 to 0.16%, most commonly to help manage pervasive developmental disorder or mental retardation.8
"More than 4% of Medicaid youth ages 6 to 17 filled at least one prescription for an antipsychotic in 2004, with 75% of these being for off-label uses.7 A number of children under 6 years of age enrolled in Medicaid programs receive ongoing treatment with antipsychotic medications.9,10" (page 3)
Discussion
Although certain atypical antipsychotic drugs are FDA-approved for specific uses in pediatric patients, the majority of prescribing (70 to 75%) is off-label for these drugs. Head-to-head comparisons of atypical antipsychotic drugs for off-label uses are few, and evidence from placebo-controlled trials for off-label use suggests that efficacy differs between drugs. Accordingly, one cannot anticipate that a “class effect” exists for atypical antipsychotics with respect to any specific clinical use or indication. here
from a letter from Citizens for Responsible Care & Research, Inc. to The Presidential Commission for the Study of Bioethical Issues Public Comment in Response to: Federal Register 76:41 (March 2, 2011) pp. 11482-11483:
a couple of excerpts:
"Part 1: Suggestions To Consider
As suggested in the Federal Register notice, in order assist the Commission in developing a thorough understanding of the adequacy of current U.S. and international standards for protecting the health and well-being of human subjects in scientific studies supported by the federal government, we refer the Commission to the public comment of CIRCARE vice president Gerald Schatz, J.D., in which he describes international law, requirements of which the bioethics community is apparently oblivious. For your convenience we reproduce the relevant portion of his comment:
“There is the International Covenant on Civil and Political Rights the United States
ratified in 1992 and it makes informed consent an absolute requirement, no exceptions,
not even in emergencies, subject to those normal legal fictions of consenting for the
incapacitated patient to medical care and so forth. Additionally, the Geneva Conventions
and Additional Protocols to the Geneva Conventions make research very, very difficult
or prohibited altogether for those individuals who are caught up in the war and armed
conflicts.” (2)
Over the past several years the International Compilation of Human Subjects Protections posted on the OHRP website has been significantly strengthened by additions of the International Covenant on Civil and Political Rights, the Geneva Conventions and Additional Protocols to the Geneva Conventions. (3) A persistent problem, however, has been a lack of OHRP guidance on the significance and applicability of this law. An additional difficulty seems to be that not only is there failure to acknowledge this law and its applicability inside and outside the U.S., it is almost surely the case that neither OHRP nor FDA are adequately resourced to implementation of this law.(sic) Consequently we urge the Commission to recommend information about this law be distributed to appropriate U.S. agencies, research partner governments, research institutions, commercial research sponsors, and appropriate NGOs. Links to the Michigan State University faculty response as drafted by Gerald Schatz to the 2005 OHRP request for comment on equivalent protections as described above, two legal articles, and electronic versions of the law in question are provided in the references at the end of this document. (3)"
"CIRCARE holds FDA and OHRP in high regard and commends staff for their accomplishments. Practically speaking, our post hoc system means that failures of protections occasion the bulk of regulatory oversight of institutions or individuals. The opening paragraph of a typical FDA warning letter refers to an inspection conducted many months earlier and addresses objectionable conduct in one or more clinical investigations which ended years previously. (4) The definition of the verb “to protect” is “to cover or shield from exposure, injury, damage, or destruction; (to) defend.” (5) We challenge the Commission to consider if is it reasonable to believe post hoc action provides meaningful protection of human subjects in research."
"A typical FDA warning letter offers two challenging paradoxes the Commission should to consider. Prior to 2007 boiler-plate language informed warning letter recipients that FDA inspections are conducted under a program, one aspect of which is to ensure the integrity of data submitted in drug or medical device marketing applications, the other aspect of which is to ensure that human subjects are protected from undue hazard or risk in clinical investigations. More recently this language has been revised to state that inspections are conducted pursuant to FDA’s Bioresearch Monitoring Program to evaluate the conduct, i.e. data integrity, and to ensure that the rights, safety, and welfare of human subjects have been protected. (op sit, p.1) The past tense of the copulative verb “have been” illustrates the paradox of a post hoc system in which the regulator proposes to protect the welfare of human subjects by inspection and enforcement after the fact." here
photo credit
4-16-2013
