Involuntary Transformation: Imagine: We have more in common than you realize

The brief phrases and sentences in quotation marks are those of a medical professional that I was fortunate enough to have a dialogue with. I say 'fortunate,' because I can be abrasive and rude; I was during this conversation---However, the professional was willing to continue in spite of my rudeness... The subject was the "off-label" prescribing of psychiatric drugs to children and the lack of Informed Consent.

It is my opinion the reason the drugs are being so widely used is that Informed Consent is not happening a majority of the time. The reason I have this opinion, is my own experience as the parent of a son who has been prescribed psychiatric drugs off label, and speaking to countless other parents who report the same experience and sense of betrayal due to not being informed of the known serious risks of the drugs by the medical professionals who prescribed them. I sincerely doubt that so many children would be taking dangerous psychiatric drugs if parents were in fact being given appropriate, relevent unbiased information on both the diagnoses and the psychiatric drugs given to their child.

There is no doubt in my mind, that I would have never have consented to giving any neuroleptic, or 'antipsychotic' drugs to my son who was emotionally and behaviorally disturbed due to being the victim of a violent crime. There is no way in hell I would have consented, much less, given him the drugs myself--IF I had been told what was known about the drugs at the time they were prescribed. I had to learn through research I have done on my own....It is one of my greatest sorrows that in my ignorance, I made sure my son took the drugs prescribed... My overwhelming sense of betrayal is devastating; these drugs have caused my precious son further harm; and according to my son, further traumatized him. The drugs have disabled my son; and there is no comfort in knowing that it is not my fault. I relied on misinformation given to me by the prescribing medical 'professionals' who have acted unethically with impunity.

My opinions and observations on this topic should not be construed to be a judgement of the nameless professional quoted, or the quality of care the professional provides to patients---in truth, I know only that the conversation in fact occurred; and that it greatly disturbed me.

" "off-label" use is legal and is not experimental use"

While "off-label"prescribing of the drugs is legal, the fact that a drug is being prescribed "off-label" means it has not been tested and approved for children and that fact is something a parent needs to be told in a dialogue which informs a parent about the nature of the diagnosis, what the potential risks, possible benefits, and what alternatives to the proposed drug are; including answering questions and providing additional sources for information in order to actually inform the parent. Otherwise, it is not Informed Consent, but simply an assent. What is happening in Real World practice is unethical, illegal and immoral: Parents are not being fully informed, they are being misled, manipulated and coerced, by some.

The fact is neuroleptic drugs have been in pediatric use for decades---without valid clinical research being the basis of this questionable practice. Due to the lack of effectiveness, most patients are given one drug after another, or multiple drugs concomitantly attempting to find one or a combination of several which will alter or control an undesirable behavior. Ultimately, professionals are treating a behavior, which is not life threatening, with drugs that cause iatrogenic injuries without sharing well documented risks, e.g. without Informed Consent. It is the very definition of human experimentation, covered under the US Code of Federal Regulations and International Law, i.e. the Nuremberg Code. Calling it "off-label" prescribing, does not actually change the nature of what is being done; nor does it make what is being done in Standard Practice safe or ethical, or less experimental.

Psychotropic drugs have the well known, documented risks of causing iatrogenic disabilities and sudden death. The only plausible explanation for the prolific use of drugs with such serious risks being widespread is that Informed Consent is not in fact obtained. It also explains why the parents whose children have been iatrogenically disabled or killed state that they had no idea their child could be disabled or die as a consequence of treatment. Not fully informing patients or parents of the known risks inherent in treating non-life threatening psychiatric symptoms with drugs that have serious risks is unethical. Failing to inform about these risks while telling both the child and the parent the drugs are treating a metaphorical disease to coerce compliance with treatment, is fraud. Telling a person that a drug will effectively treat a mythological neuro-biological disease, that has never been identified is a deception intended manipulate a person's behavior when successful and detrimental to the patient, is the definition of criminal fraud...

Not informing parents that the drugs alter normally functioning physiological processes none of which are known to be contributing to the undesirable behavior being treated while failing to inform of the risks for brain damage, heart damage, permanent neurological impairments, disability and death is Standard Practice. Standard or not, this practice does not conform to the Ethical Guidelines for Informed Consent of the AMA; it violates a person's Constitutional Rights, and a Parent's Constitutional Right to make medical decisions for their child.

"Not validated by thin air- but by extrapolation and empirical practice- much of medicine is still an art"

Since when does that mean people can be misled, coerced and manipulated in order to be 'effectively treated?' The 'neuro-biological disease paradigm' that is being crammed down our necks, is derived from or more accurately survived the supposed end of the Eugenics movement. All of the coercive manipulative psycho-education type of 'treatments' used in Standard Practice INCLUDING the Court Mandated treatment, using CPS, Police and the Courts is exactly how eugenics is done. Here and now. It was done in Germany by the Third Reich, it is also done, here and now, in this country.

Lets remember, to be 'evidence-based' prescription practices for drugs treatment and recommendations for them should be derived from the Clinical Trial Data; not based solely on anecdotal evidence and a consensus of subjective opinions. "Off label" prescriptions are (theoretically) to be based on some scientific empirical data. e.g. using a safe and efficacious drug to treat either a condition or a population for which the drug has not yet been FDA approved based on the fact that the drugs have been used effectively and safely to treat another diagnosis or population. Off label prescriptions were not supposed to become Standard Practice just because prescribers have the 'legal' option! e.g. adult to pediatric use of drugs approved for adults or drugs approved for symptoms of psychosis prescribed to extinguish aggressive behavior. In the case of neuroleptics, they are 'effectively treating' a minority of the patients who have psychosis for which the drugs were initially FDA-approved, a fact that should cause any reasonable person--including medical professionals to ask, "why are teratogenic drugs being used so prolifically and indiscriminately in Standard Clinical Practice?"

"TEOSS study- specific for early onset schizophrenia- doesn't account for use for atypicals 4 other diagnoses- eg mood disorders"

That is EXACTLY my point! Clinical standard practices and treatment protocols are not based on clinical trial evidence! Clinical trials are being conducted to validate standard practice already in use--which is backwards--and driven by the growing criticism of psychiatry's qquestionable claims and methods and the harm being done to people who permanently disabled and die as a result or it.

"you are citing ONE small study- extensive database on neuroleptics"

Apparently, without even realizing it, the doctor is making my point. TEOSS doesn't account for the widespread use of neuroleptic drugs in the pediatric population; no studies do. There is no ethical medical rationale or evidence base supporting use of the drugs in the pediatric population, nonetheless, it has been standard practice for decades. The purpose of the TEOSS Drug Trial was to validate the Standard Practice of using the the newer Atypical drugs as First Line treatment for early on-set schizophrenia; to show that the newer more expensive "Atypicals" were safer and more effective, than the older, cheaper drugs. The results? The newer drugs are not safer, nor are they more effective. A small percentage of the patients were effectively treated--12%. Significantly, the newer drugs tested in TEOSS were subsequently FDA approved for pediatric use based on research conduted in other countries...

How many parents whose children are given these drugs--for any diagnosis--are told that more than 1 but less than 2 out of 100 treated may die; or that 50 % percent of the children who take neurolepic drugs are expected to develop Tardive Dyskinesia, an untreatable neurological condition which can be permanent and disabling; even if the drug is stopped? I have not met a single one yet! I am appalled and totally disgusted when parents tell me of the high cholesterol, obesity, diabetes and heart issues their child has; yet are unaware that these are known adverse effects of the drug prescribed to their child!

"Truth is about risk vs benefit-- no intervention in medicine is 100 % risk free"

Why is it that instead of responding to issues of Informed Consent and the lack of EVIDENCE justifying prescribing psychiatric drugs for behavioral or social problems using what are teratogenic drugs, every single medical professional I have encountered has avoided the issue altogether, or pointed out that there is no risk-free medical treatments? Rationalization and justification are avoidance techniques/behaviors. Once a professional gets to the point that they cannot rationally put forth a valid argument defending their opinion; that is, an evidence-based defense for "off-label" prescribing of psychiatric drugs; or even validate the FDA-approved uses, it becomes crystal clear: It is, it appears, because they NEVER considered that relying on "peer-reviewed" journals for information may mean they are misinformed! If professionals rely on professional journal articles which offer a biased reporting of the data, and use Treatment Protocols and algorithms based on a consensus of subjective opinions instead of empirical data, they are not serving their patient's best interest. The reality is: the recommendations from psychiatry's expert consensus guidelines on the diagnosis and treatment of psychiatric diagnoses are rarely supported by empirical evidence of diagnostic validity or treatment effectiveness and safety; but do provide effective support to an extremely successful marketing agenda...

I can understand why professionals would rely on these sources; however, in light of what is now common knowledge about the basis, e.g. validity, of these sources, it is unacceptable for professionals to continue to unquestioningly rely upon them. Some professionals purposely avoid examining their own treatment of patients in this manner due to confidence in their peers; but patient trust and medical ethics are not built on a professionals confidence in their peers, or risk-free treatments. It is based on ethically providing competent and therapeutic care with due diligence of duty. Patients deserve to be told the truth about what their diagnosis is based upon, and factual information about the possible benefits and potential risks of the treatment their doctor is recommending! When the patient is a child, their parents deserve to be given accurate information so that they can perform their sacred duty to protect their own child.

It is about the flawed trial designs, the incomplete, biased reporting of the evidence derived from clinical trials published in "peer-reviewed" professional journals that medical professionals rely upon.

It is also about using one's critical thinking skills, individual professional responsibility, and medical ethics. It is about understanding and relying upon sound ethical principals to guide one's own professional assessment of relevant information. Altogether, these flaws require that a professional never assume that a "peer-review" process replaces the need for critical analysis of the actual scientific data. The INTEGRITY of the Medical Profession has been seriously damaged, and continues to be eroded by the American Psychiatric Association's failure to police the unethical conduct of individual members who continue to be considered Key Opinion Leaders.

The APA has failed to hold individual psychiatrists accountable; especially those whose outrageous violations of the Hippocratic Oath and their failure to use sound, ethical scientific standards when conducting academic research involving Human Subjects. These same 'Lead Researchers" base Practice Parameters and Treatment Algorithms upon consensus of subjective opinions, not the empirical data derived from their own research. These standards are supposed to be supported by subjective observations, and based on the data; not based on subjective opinions, and contradictory to the scientific data!

It is a evident that the diminishing credibility of psychiatry is due to the laissez faire manner in which it develops it's 'standard practices,' and it's unwillingness to hold unethical researchers accountable, or even to retract research articles which have been discredited and invalidated from it's own 'evidence' base! Ultimately, this blind-eye approach to the conduct of it's members, while continuing to rely on their seriously flawed methodology and corrupt work products is what continues erode trust, and fuel the loss of integrity of psychiatry as a medical specialty.

Doctors who are medical specialists or generalists rely on the corrupt information generated by a relative few unethical psychiatric researchers; researchers who are well-funded and have serious conflicts of interest, and whose work often lacks validity; to their own patient's detriment. This lack of professional integrity is not in any patient's best interest; and has an impact on every patient's best interest.

The regulatory failure in the FDA approval process, is due to conflicts of interest and the same ethical failures which infect academic research. Another failure of the FDA however, ensures that some of the lax ethics in research and prescribing of psychiatric drugs are easier to dismiss and disguise; or worse, remain undiscovered rationalized and/or justified away. The failure to which I am referring is the failure to require that Medical Professionals report adverse events, including death, to the AERS data base once a drug is FDA-approved. The data from which one would more accurately assess risck/benefit of a particular drug. It would be necessary to collect adverse events data from Real World clinical practice of FDA approved drugs... Basing risk/benefit profiles solely of FDA-approved prescription drugs on the clinical trial data and anecdotal evidence is short-sighted, fundamentally flawed and NOT scientific. It is no doubt contributing to the further corruption of the evidence base itself. The data from Real World clinical practice is germane to both the efficacy and the safety of any and every FDA-approved drug. This adverse event data is not being collected; it is not required of medical professionals to report it; and I, for one do not believe it is an 'oversight' or an 'accident.'

I have spent hours examining this data base, and what is frighteningly clear to me is that only a minority of the drug-induced deaths, drug induced iatrogenic illnesses and disabilities; and drug induced life-threatening emergencies listed are reported by medical professionals who prescribed the drugs which caused the 'adverse events.' The majority of the deaths are reported by attorneys or family members; not prescribers. Another significant, morally reprehensible fact which is evidence of an ongoing tragedy and the numerous aforementioned regulatory and ethical failures; is the number of infants and children under six listed.

a blessing and a hopeful prayer from the professional:

"We have more in common than you realize-

transform that anger into passion for change-

more sustaining and healing"

It is my sincere hope that we all come to know
we have more in common than we are now aware of...

Imagine that...