via The American Academy of Child and Adolescent Psychiatry:
A Guide for Community Child Serving Agencies on Psychotropic Medications for Children and Adolescents
a couple of excerpts:
"A child who is difficult to manage or has a mood disturbance may benefit from medication if there is scientific or clinical evidence that the medication is safe and effective for the specific diagnosis or behavioral indication." (emphasis mine)
"When a youth has been taking a medicine for a long period of time, the brain may have become used to it, and abrupt discontinuation can cause side effects that should not be mistaken to mean that the medicine is still needed. For this reason, a decrease in dosage or discontinuation must be conducted gradually. This does not mean that the youth is addicted to the medication but rather that the youth’s brain has become used to the medication and that discontinuation must occur gradually so that the brain has time to adjust."
"Some psychotropic medications have FDA Black Box Warnings. Medicines with black box warnings are still FDA approved, but their use requires particular attention and caution regarding potentially dangerous or life threatening side effects. Selective Serotonin Reuptake Inhibitors (SSRI’s) carry a black box warning that they may cause suicidal ideation or behavior, although the most recent review of the evidence is not conclusive that SSRIs increase suicidal behavior. Families should work in consultation with their child's physician or other mental health professional to develop an emergency action plan, called a “safety plan”. This is a planned set of actions for the family, youth and doctor to take if and when the youth has increased suicidal thinking. This should include access to a 24-hour hotline available to deal with crises. AACAP recommends that family members discuss this with the provider if they are uncertain about a black box warning.7" (emphasis mine) here
The claim that a 'recent review' was not conclusive has no citation---begging the question, what review is this conclusion supposedly based on? Stating this claim immediately after sharing the fact there is a Black Box warning for SSRIs gives the impression that the Black Box warning is nothing more than a nuisance warning the AACAP is passing along, because they must. Stating that a recent review was 'not conclusive' immediately after sharing there is a FDA Black Box warning for suicide, in effect nullifies the FDA warning. At the very least, the claim minimizes the importance of the warning. The fact of the matter is, the increased risk of suicide is not the only risk identified in the FDA's Black Box warning on SSRIs; it is simply unethical for the AACAP to issue a document which minimizes a serious risk and fails to mention altogether the other behaviors identified in the warning.
via the FDA:
a couple of excerpts from the FDA's Black Box warning for SSRI antidepressants:
Revisions to Product Labeling
[These changes should be made to the box warning at the beginning of the package insert.]
DRUG NAME
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Insert established name] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. [Insert Drug Name] is not approved for use in pediatric patients. [The previous sentence would be replaced with the sentence, below, for the following drugs: Prozac: Prozac is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD). Zoloft: Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). Fluvoxamine: Fluvoxamine is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD).] (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for [Insert Drug Name] should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. (Emphasis: FDA original document) see here
via AACAP:
Prescribing Psychoactive Medication for Children and Adolescents
Revised and approved by the Council on September 20, 2001
To be reviewed
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.
(emphasis mine)
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. (emphasis mine)
This is a Policy Statement of the American Academy of Child and Adolescent Psychiatry here
Child psychiatrists seem to believe that anecdotal 'evidence' is a sufficient basis for prescribing teratogens with fatal risks; while minimizing the importance the risks of adverse events, including disability and death.
There is exactly one RUPP study listed on the Clinical Trials website:
Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders here So there is no effort to do the clinical trials that would justify (or refute) the Standard unethical Practice of off label prescriptions. Psychiatrists are defending their "right to prescribe" teratogenic drugs without any empirical evidence of their therapeutic value, without evidence of their safety, and without being honest with patients or their parents about the risks for iatrogenic harm to children. It is the very definition of Human Experimentation without Informed Consent. Codifying off label prescribing as a Standard of Care, and a first line treatment; was based on consensus; this is not in reality an 'Evidence Based Practice,' it is dishonest and fraudulent to state that it is. A consensus is evidence of agreement, nothing more, just because off label prescribing is a common practice, does not make it an ethical or therapeutic practice, nor does it mean it is medically justifiable. Off label prescribing of psychotropic drugs is a common medical practice encouraged by psychiatry. Done without full disclosure of the experimental nature of off label drug treatment, precludes obtaining "Informed" Consent, for Human Experimentation has become an accepted psychiatric standard practice.
via The Alliance for Human Research Protection:
Since May, 2008, the Institute for Safe Medication Practices, an independent nonprofit organization, has been monitoring FDA's MedWatch database, publishing quarterly reports (QuarterWatch ). The latest report found that in 2011, the FDA received 179,855 reports of serious, disabling, and fatal adverse drug events in the United States. This is an increase of 9.4% from 2010. In 2010 that number increased by 21% from 2009. Since 1998, the percentage increases of reported serious adverse drug events were in the double digits.
Most reports (88%) were submitted by pharmaceutical companies and they involve patent-protected drugs. Company reports about deaths were found to be “nearly useless” in that they are vague, failed to report critical patient information, such as cause of death or age of patient. Generic drug manufacturers rarely file adverse drug reports.
The authors—Thomas Moore, Curt Furberg, MD, PhD, and Michael Cohen, RPh, MS, ScD—point out that the most valuable barometer of drug safety risk is found in reports submitted directly to the FDA by physicians and patients. Unfortunately, the FDA estimates that serious adverse drug event reports submitted by physicians and patients constitute less than 1% of actual serious injuries. In 2011, physicians and patients submitted 21,002 adverse event reports to the FDA. These reports represent at least 2.5 million actual serious prescription drug injuries, including 128,000 deaths.
In 2011, the five leading drugs ranked by the number of direct adverse event reports from physicians or patients: anticoagulant drugs, Pradaxa and Coumadin linked to hemorrhage; antibiotic Levaquin linked to tendonitis, fatal allergic reaction, nerve damage resulting in pain, burning or numbness, and central nervous system abnormalities including depression, confusion; anti-cancer drug Carboplatin linked to bone marrow suppression; antihypertensive Lisinopril (Prinivil, Zestril) linked to dizziness, nausea, anxiety, insomnia, swelling, difficulty breathing.
The other valuable source of information documenting drug safety risk, are litigation-related adverse event reports submitted to the FDA. The five drugs most frequently cited in litigation were patent-protected: the anti-nausea drug metroclopramide linked to tardive dyskenisia; the contraceptive drugs Yaz and Yasmin linked to blood clots and stroke; the anti-diabetes drug Avandia linked to heart attacks; the anti-smoking drug Chantix linked to suicide and homicide; and the acne drug Accutane linked to suicide.
Fifty-eight drugs carry FDA-mandated warning labels about the risk of suicide and suicidal behaviors. The most frequently identified drug posing a suicide risk in 2011, was SEROQUEL, with 197 reported cases. Seroquel was first approved for schizophrenia and manic depression (bipolar) but is now widely used for a variety of approved and unapproved conditions, including depression and as a sleep aid. The second ranked drug that poses a serious risk of suicide is Chantix a drug approved as a smoking cessation aid--with 187 reported cases. Indeed, since its approval for marketing in 2006, Chantix has been identified in reports to the FDA as a high risk factor for suicide and homicide. Both of these drugs also pose serious cardiovascular risks. read the entire article here
I have yet to meet a parent who had been warned about risk of suicide, or the well-documented serious risks of any of the psychotropic drugs their children are prescribed---nor are they told the drugs are not approved for pediatric use or to treat the symptoms for which they are prescribed. The failure to warn is clearly common, just as it is common for professionals to minimize the risks and deny the harm done. None of the parents I am in touch with whose child experienced "agitation, irritability, unusual changes in behavior" immediately before taking their life had been warned. Some were advised to increase the dose of the drug!
While the AACAP's claim that the drug companies do not want to spend the money to have psychiatric drugs tested for safety and efficacy in order to gain FDA approval for pediatric use may be true; it is also true that the FDA also approves drugs on skeptical evidence and then does not require the drug companies to actually do the after-market clinical trials which are supposedly 'required' under PDUFA, which also contributes to the lack of safety data available. The fact that the AACAP and the American Psychiatric Association have not issued any position statements, and have not advocated for the correction needed in either the approval process, and compliance with after-market research requirements, is less than ethical or honest, all things considered. The overwhelming risk of harm these two glaring failures represent for all psychiatric patients, should be a primary concern for both of these professional organizations; but are not even discussed. Psychiatrists could, by consensus institute a standard practice that requires psychiatrists to report adverse events patients experience when taking the psychiatric drugs prescribed to them. Doing so would serve the best interest of psychiatric patients.
I have no doubt whatsoever psychiatric patients' best interests are sacrificed by some psychiatrists altogether. Whether it is due to inaccurate interpretations, misperceptions, innate biases, errors of attribution, hubris or malice really doesn't really matter. All of these are reinforced by an obvious Conflict of Interest. Academic psychiatry, the APA and the AACAP are dancing to the fiddler's tune and the pharmaceutical industry is fiddling away like mad...The illegally marketing of psychiatric drugs has been going on for decades; it is a massive ongoing criminal enterprise that would not have been so successful without the members of the APA and the AACAP being willing accomplices and co-conspirators; some are complicit by remaining silent, but complicit nonetheless. The silence is deafening to this MadMother. The lawsuits and settlements have recouped a very small percentage of what has been stolen from the American people. The fraud continues unabated and the membership of the APA and the AACAP continue to be willing participants denying their culpability; while failing to discredit the criminal behavior of academic researchers, pharma whores, and clinical practitioners; sacrificing their integrity along with their patient's lives.
Instead, these 'professional' groups issue policy statements which point to other institutions and other medical professionals as the cause of indiscriminate and widespread use of drugs that have no evidence which supports their use...The fact remains, without psychiatric researchers, and psychiatrists acting as pharmaceutical marketeers akin to the snake oil salesmen of days gone by, We the People wouldn't have 'the problem' we are now faced with. Is it a reasonable expectation that a profession that continues to participate in a massive criminal enterprise and continues to deny any responsibility for the harm it has caused to millions of people, and society as a whole, will suddenly exhibit ethical integrity, and begin to serve the best interests of their patients?
Washington State Law allows for adolescents to consent for their own Mental Health treatment at the age of 13; which means adolescents also have to give consent for treatment information to be shared with parents/caretakers...how would any care taker know to watch for signs of adverse events if the Law excludes them from the treatment process? I say this because in my personal experience, the age of consent law is used to exclude parents---it was used by Jon McClellan who claimed he had no duty to obtain my Informed Consent to treat my son at CSTC. This blatant lie was repeatedly proffered as a justification for his ethical and legal failures while he was "treating" my son without consent in spite of my vehement protests. Imagine, knowing that Washington State Administrative Code applicable to children who are in the custody of the State of Washington required my Informed Consent, or a Court appointed advocate to give consent; Federal Medicaid and Child Welfare Law also required Informed Consent from a parent, as does the National Institute of Health, and the Health and Human Services Office of Human Research Protection. When I brought my son home severely impaired by the unethical treatment illegally "provided" by Jon McClellan, two psychiatrists in the two Community Mental Health Clinics with psychiatrists on staff also used the age of consent as a justification for ignoring my concerns altogether; both claimed they needed no consent from a parent, and even claimed my brain damaged son was the not complaining so there was no need to discuss the harm the drugs were causing... Both of these 'doctors' claimed as McClellan had, that I had no say since Isaac was over the age of 13. Both refused to even discuss the obvious ongoing harm being done to my son's overall health and well-being.
These adverse effects are actual diseases which psychiatrists refuse to medically treat, and refuse to make appropriate referrals to the medical professionals who do treat them. My son has profound iatrogenic, i.e. physician caused, neurological and cognitive impairments; he has been profoundly disabled since before his 14th birthday. It is utterly horrifying to know there is not a single ethical psychiatrist in the Community Mental Health system in this county, or the next; not that I am aware of any way... I am outraged that I am not listened to; but what is killing me is that fact that it is not me who these so called doctors are consistently failing; it is not to me that they owe an ethical duty to.
Since before my son was born, it has been a Federal mandate that federally funded mental health and social services are to be, "client directed," in the case of child, to be child-centered and family-directed. Indeed, the Mental Health Transformation Grants such as the Children's Mental Health Initiative, Systems of Care grant that Yakima County received is in all reality, a program in which the Federal Government is paying Yakima County and it's federally funded child serving systems to come into compliance with Federal Regulations that are decades old; to stop committing fraud, and stop failing our community's children. It is an additional insult that I have been aware for almost twenty years now that I have had to fight incompetent public servants; instead of being able to access the care my my son needed for his traumatic injuries. Instead I was robbed of my parental rights without cause, and forced to bear witness to felony crimes being committed that further traumatizing and ultimately disabled my son. These Federal Regulations were instituted before Isaac was born and were instituted to prevent exactly the sort of mistreatment and the Medicaid fraud that paid for his mistreatment. Federally funded social service and mental health programs are to be client-centered and family driven. Which means in all reality that not only was the manner in which my son was mistreated actually criminal and inhumane; the professionals responsible for the gross mistakes made committed Child Welfare and Medicaid Fraud robbing ALL of US in order to pay for it---Well over a million dollars was defrauded from federal programs in order to pay for crippling my once brilliant son. I can not describe in polite terms what it is like to have unethical 'professionals' to this day insist that I need to respect their authority, and tell me I need to, "just get over it." I can barely contain myself when these 'professionals' imply that I should be grateful, because after all, the help they provided cost a lot of money...The fact that these so called professionals stole the money from all of my neighbors and my extended family in order to pay for the harm they caused my son under the guise of providing 'help' is contemptible.
Contempt is like respect, it must be earned.
Evidence for the Neurotoxicity of Antipsychotic Drugs This is an Affidavit that conforms to the Rules of Evidence used in Courts of Law---it is derived from actual research data
TEOSS Drug Trials
an excerpt:
Acknowledgments
This study was supported by NIMH grants MH-61355 (Dr. Findling) to Case Western Reserve University, MH-61464 (Dr. McClellan) to the University of Washington, MH-62726 (Dr. Frazier) to Harvard Medical School, and MH-61528 (Dr. Sikich) to the University of North Carolina. Drs. Sikich (K23 MH- 01802) and Hlastala (K23 MH70570) were also supported by NIH career development awards. The research was conducted in NIH supported Clinical Research Centers at Seattle Children’s Hospital, University of Washington (M01-RR-00037) and at the University of North Carolina at Chapel Hill (M01-RR00046 and U54RR024383).
Another strange thing about this five year trial, is the discrepancy in the number of children enrolled. Some reports say 119, others 116; and incredibly, some have both figures. Some data may be open to interpretation, or imprecise, however, the number of children enrolled in a $35 million dollar seeding trial conducted with the hope of gathering evidence to support FDA approval for pediatric use of the neuroleptics trialed, is not one of them.
Posts
No comments:
Post a Comment