Informed Consent and the Psychiatric Drugging Of Children

There has been a dramatic increase in the numbers of United States children on psychiatric drugs. In 1971, when Ritalin prescription use was approaching 200,000, our country was alarmed enough that the United States Congress convened an investigation, and the Drug Enforcement Administration classified Ritalin and other amphetamines as Schedule II drugs, a category that indicates significant risk of abuse. Since that time, the explosion in use of psychiatric drugs with children in this country has been phenomenal. According to the Drug Enforcement Agency, there was a 700% increase in the production of Ritalin between 1990 and 1997, 90% of which is consumed in the United States, mostly by children diagnosed with the controversial label of Attention Deficit Hyperactivity disorder (ADHD). Today we have an estimated 8,000,000 school-age children in this country on psychiatric drugs (Breeding, 2000).

The fact that millions of children are taking prescribed psychiatric drugs means that millions of parents have agreed to this recommendation for their children. The legal doctrine of informed consent requires a physician to disclose sufficient information for a patient to make an ÒinformedÓ decision about a proposed treatment. Our nationÕs courts have explained that, Òtrue consent to what happens to oneÕs self is the informed exercise of choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each.Ó (Baker, 1997) In the case of our children, this doctrine must be interpreted to mean that parents have a legal right to sufficient information necessary to make a fully informed choice on behalf of their children. This article examines the issue of informed consent in the psychiatric drugging of school age children in the United States, argues that informed consent is systematically violated in this domain, and presents a look at what authentic informed consent for parents to decide about psychiatric drugs for their children would entail. In order to gain a perspective on the issue, a brief overview of informed consent in modern psychiatry is required.

Psychiatry and Informed Consent

In the modern practice of medicine, the doctrine of informed consent is fundamental. Issues of physician responsibility and malpractice are major forces shaping the delivery and cost of health care services in the United States. As John Baker (1997) reveals in his legal review of malpractice issues regarding Tardive Dyskinesia (TD) caused by antipsychotic drugs, at least one court has written that Òevery person has a right to determine and control what is to be done to his or her body; and a surgeon who performs an operation without his patientÕs consent commits (a battery) for which he is liable to damages.Ó No wonder the complex legal forms one is required to sign in order to undergo a surgical procedure. BakerÕs interpretation that a patient might allege battery in the context of TD litigation would surely apply to other psychiatric drugs. The failure to disclose potential harmful effects of stimulant or antidepressant drugs prescribed for children must be equally tantamount to treatment without consent as the failure to tell patients about the risks of TD due to antipsychotic drugs.

While the pharmacological arena is much broader and less controlled than the domain of surgery, issues of responsibility and malpractice are highly significant. Drug company liability is an ongoing concern, as these corporations defend themselves against lawsuits by complainants who attest to harm suffered by a drug. The Food And Drug Administration is under scrutiny as many allege that this agency has become coopted by the pharmaceutical industry, resulting in a drug review process heavily weighted in favor of drug approval (Willman, 2001). The majority of the pharmaceutical research is, in fact, funded by the very drug companies who want their products on the market as soon as possible (e.g., Duncan et al, 2000).

The application of informed consent in psychiatry raises a unique set of problems related to the existence of fundamental differences between the concepts of physical and mental illness. The practice of medicine has developed hand in hand with clarification of and allegiance to the scientific method. Simply put, there is a process whereby medical scientists posit the existence of a disease entity, then confirm the presence of a physical or chemical abnormality which is a marker for the disease. By this marker, physicians can know and demonstrate to patients the presence of a specific disease, and can make a specific disease/no disease differentiation between those who have the disease and those who do not. Treatments for a disease are relevant only when the disease is verified, and are judged accordingly on a risk/benefit analysis relevant to the health of the patient with or without the treatment. If the physician is unable to verify the existence of a disease by confirming the established marker for a disease, then he has no medical prescription to offer.

The process whereby a psychiatrist responds to so-called mental illness, however much the trappings of a doctorÕs office or hospital may emulate those of physical medicine, is remarkably different. No problem routinely seen by psychiatrists has been demonstrated, according to the simple criteria above, to be a legitimate medical disease. There is no objective marker for any psychiatric illness. (One may exclude the exception where there exist psychiatric symptoms due to disease diagnosable by objective markers, such as organic brain syndrome or thyroid malfunction). To test this, ask a psychiatrist to show you the article or articles in the scientific journals that prove the existence of a physical or chemical abnormality by which a disease/no disease differentiation can be made for an alleged psychiatric illness. There are none for any diagnosis, including those we constantly hear are proven to be genetic or biological in nature, such as schizophrenia, depression, and bipolar disorder.

The fact that psychiatrists treat unproven illnesses may be their most distinguishing difference relative to colleagues in other branches of medicine. Imagine what it might be like if the practice of oncology involved oncologists offering their assortment of chemotherapies based on their observations and opinions of a patientÕs behavior and language, and the observations and opinions of those around the patient. Is it not true that most of an oncologistÕs patients are willing to undergo the terrible effects of chemotherapy just because the doctor has shown them the physical evidence of cancer, and their analysis of the cost/benefit issues leads them to conclude that taking the toxic chemicals is their best option to live longer? Might it not happen that a much greater number of cancer patients would balk at taking the chemicals if their doctors could show no physical evidence of disease?

It is apparent that, in order to profitably continue without being able to demonstrate to patients the existence of their disease, a branch of medicine has two options. One is to abrogate informed consent directly by lying, misleading or withholding information. The other is to withdraw the right to choose. This latter defines the second major difference between psychiatry and other types of medicine. Generally speaking, adults are granted the right and responsibility to accept or refuse medical treatment, even when the existence of a disease is confirmed. Psychiatry, however, operates as an agent of the therapeutic state through the doctrine of parens patriae (Kittrie, 1971). Once an individual is discerned to have a Òmental illnessÓ of sufficient severity, that individual is considered to be incapable of independent decision-making, and is effectively considered a dependent of the state. This doctrine is in full force today, as involuntary commitment provides the legitimized underpinnings of the ongoing abrogation of the civil rights of significant numbers of United States citizens judged to be mentally ill.

It is apparent that our society allows for systematic abrogation of human rights in the name of a parens patriae therapeutic state supposedly functioning to care for the mentally ill who are judged to pose a danger to themselves or others. It is accepted that fully informed consent is impossible for the mentally ill because of their irrationality and incompetence. As I have described elsewhere (Breeding, 2000a), using electroshock as an example, even where is a pretense of informed consent in psychiatry, its practice is routinely violated. In nursing home care, there currently is not even a pretense. Is it a coincidence that our elderly women receive the brunt of psychiatric electroshock, that nursing home residents are a booming industry for psychiatric drugs, and that children are the most rapid current growth market for the psychopharmaceutical industry? Those dispossessed of power are always the victims of oppression. Informed consent is most easily violated with those lacking political and economic power to fight back.

Informed Consent, Psychiatric Drugs and Children

It is undeniably true that more and more of our children, literally millions, are taking stronger and stronger psychiatric drugs today. Methylphenidate (Ritalin) is still number one, but other stimulants represent one third of the childrenÕs market (Breeding, 2000). Adult antidepressants are being used more freely with children. Incredibly, these extremely potent drugs are frequently given to toddlers (Zito et al, 2000).

Clearly children are powerless to resist this trend, and legally incapable of informed consent. Yet we know it is not the children who decide. It is true that parens patriae plays a big role in childrenÕs care in our society.

According to Winnie Imperio (2000), the Bazelon Center for Mental Health reports that gaining access to mental health care for children is so difficult that parents often end up giving up custody to ensure care. The center estimates that approximately 2.1-4.1 million children aged 9-17 years have a serious mental or emotional disorder. We are told that last year 23% of parents of children with behavioral disorders were told that they needed to relinquish custody to obtain intensive mental health services for their children, and that 20% actually gave up custody.

The therapeutic state has also been known to coerce parents with custody of their children into complying with recommend psychiatric drugging of their children (Thomas, 2000). In a less dramatic way, parents are routinely pressured by educators and mental health professionals to use drugs with their children. Before elaborating on informed consent in this context, a brief description of the most typical process resulting in a childÕs being placed on psychiatric drugs should be made clear.

The most common entry point of a child into psychiatry is during the transition from the preschool life into the early elementary school experience. This time is difficult for many children for many reasons (Breeding, 1996; Gatto, 2001). Rather than face the tough task of finding the reasons that school is not working for a given child, we assume that there is something wrong with the child. The key concept to understand when it comes to psychiatry in the schools, then, is selection.

Selection

Institutional psychiatry and compulsory age-graded competitive education share many things in common, and one of these is a primary value on selection. Millions of young people are being selected out based on a judgment that their behavior is unacceptable. Parents are then notified that there is a problem, and are typically encouraged to seek a psychiatric evaluation to determine whether their child might have Attention Deficit Hyperactivity Disorder (ADHD), as that is by far the most popular psychiatric diagnosis for children. It is in a class of so-called Disruptive Behavior Disorders (DBDs), all diagnosed according to behavioral criteria listed in the Diagnostic and Statistical Manual (DSM) of the American Psychiatric Association.

Selection Means Diagnosis Means Treatment

A child is selected and referred to a psychiatrist or psychologist for an evaluation to determine a diagnosis and decide whether the child has a psychiatric disorder. Once a child is selected, a thoroughly predictable process with thoroughly predictable results is set in motion. It is extremely rare for a child referred to a psychiatrist or psychologist for evaluation of a disruptive behavior disorder (DBD) to be given no diagnosis. These people are in the business of giving diagnoses. As Thomas Szasz makes clear, psychiatric diagnosis is not descriptive, but prescriptive. Just as referral almost inevitably leads to diagnosis, diagnosis means treatment. When a child is selected out as a behavior problem, he or she is being chosen for treatment and special services. Biopsychiatry assumes that these behavior problems are diseases caused by biological and genetic defects in the sick child. The treatment of choice is pharmacological (drugs).

Informed Consent for Parents

In spite of all this evidence of a therapeutic state in action, our society in principle considers parents legally and morally responsible for medical treatment decisions for their children. In fact, parents usually are granted the right, albeit with pressure and disapproval, to say no the psychiatric drugging of their children. Yet more and more are saying yes. For the purposes of this discussion, the question that remains is whether this ÒyesÓ is a fully informed consent. In an earlier article on electroshock and informed consent, I discussed four ways in which informed consent is violated (Breeding, 2000a). I will now cover these same four areas in the context of parentsÕ decisions to give their children psychiatric drugs.

Denial and Minimization of Harmful Effects

The first violation involves denial and minimization of harmful effects of the drugs. Parents are typically told that Ritalin, for example, is a mild stimulant, proven safe and effective in the treatment of ADHD. They may be warned about a small number of the common physical effects, such as that it sometimes affects appetite or sleep, and that dosages sometimes need adjustment. They are almost never given or strongly encouraged to obtain a pharmacy insert or to otherwise thoroughly research the drug. Virtually everything else is usually not told. They are not told that it affects virtually every organ system of the body (Eberstadt, 1999), or that some children die; 160 Ritalin-related deaths were reported to the FDA between 1990 and 1997, mostly cardiovascular in nature. If parents are told anything at all about the likelihood of brain atrophy with long-term stimulant drug use, it is the lie that research has demonstrated that ADHD children have brain abnormalities in two specific but still coarsely defined brain regions of the frontal lobes and basal ganglia.

In their joint presentation to the National Institutes of Health Consensus Conference on ADHD, November 16-18, 1998. James Swanson, Ph.D., of the University of California at Irvine, and F. Xavier Castellanos of the National Institute of Mental Health (NIMH), among the most prominent of ADHD researchers, said these brain abnormalities were a component of the ADHD Ôphenotype,Õ Swanson posited that it had genetic basisÑan abnormal Ôgenotype.Õ In attendance at that conference was a neurologist, Dr. Fred Baughman, who is a leading challenger of the ADHD industry. Baughman took the microphone and asked: "Dr. Swanson, why did you not mention that virtually all of the ADHD subjects in the neuroimaging studies have been on chronic stimulant therapy and that this is the likely cause of their brain atrophy?" (Baughman, 1999)

Parents are also usually not told that methylphenidate is classified as a controlled substance by the Drug Enforcement Administration (DEA) because of its highly addictive nature and risk for abuse. A highly esteemed behavioral pediatrician testifying at the special hearing sof the Texas State board of Education in November 2000, stated his assurance to the board that methylphenidate was not addictive, and that children prescribed psychiatric drugs did not abuse them. He was followed shortly after by Gretchen Feussner, a DEA pharmacologist, who assured the Board that it was a substance controlled and monitored by her agency exactly because of its proven addictive potential. Fuessner also presented data showing that up to 20% of young people with psychiatric prescriptions abuse their prescribed drugs. Parents are almost never told that research has repeatedly demonstrated that neither animals nor humans can tell the difference between cocaine, amphetamine, or methylphenidate when they are administered in the same dosage and form; their effects are nearly identical (Woodworth, 2000).

This highly significant fact that psychiatric drugs are generally addictive, creating dependency and tolerance, is typically minimized or denied by psychiatric professionals. The common progression from a relatively small dose of Ritalin to a higher dose of Ritalin to a stronger amphetamine such as Dexedrine to an adult antidepressant such as Prozac or Wellbutrin to some form of polypharmacological cocktail is well-known, but parents are not told about addiction and about this trend in psychiatric prescribing practices. They are not told about the grave dangers of drug combining. For example, consider the findings that mixing three drugs can give patients a 50% chance of a drug interaction and mixing six makes it extremely likelyÉor that an accumulation of Prozac in the brain results in at least a 10 fold magnification of other drugsÉor that one alcoholic drink would have the effect of ten with Prozac and 40 with Paxil (Tracy, 1994). In a related way, parents are not told about the challenges and dangers of drug withdrawal. Regrettably, it is customary practice for doctors and other adults to interpret behavior of a child coming off psychiatric drugs not as the withdrawal symptoms that are inevitably present, but as evidence that the child still needs the Òmedication;Ó in other words, as the progression of the childÕs alleged disease. Legitimate informed consent must seriously address the issue of drug dependency and withdrawal. There are excellent books available on this topic (Breggin & Cohen, 1999; Breeding, 2000b; Tracy, 1994).

The psychological effects are also enormous; issues like shame and stigmatization, and character and responsibility are crucially important (Breeding, 1996; Breggin, 1998). Parents are also rarely told of political, social and economic considerations for their child. These include concerns related to the reality of a psychiatric label and history following the child through his or her educational career. These are concerns within the school system; they are also concerns without. For example, use of prescription psychiatric drugs normally excludes a child from service in the armed forces of the United States.

Continuing with violations of consent by neglect of significant information, I have yet to find a parent who is told by their prescribing doctor that there is absolutely no evidence that stimulant drugs have any positive long-term effects in any important area of a childÕs life: in learning, behavior or social relationships. The final statement of the 1998 NIH Consensus Development Panel on ADHD concludes, ÒThere is no information on long-term treatment (treatment listing more than one year).Ó

Violation of Minimal Professional Guidelines For Drug Approval and Administration

A second way that informed consent is routinely violated in psychiatry is that guidelines for the approval and administration of psychiatric drugs with children are routinely and systematically violated. Peter Breggin, in Talking Back To Ritalin (1998), reviews the history of this drug. Ritalin was first approved by the FDA under lenient standards in 1955. Despite widespread methylphenidate abuse and addiction, it was only in 1969 that these problems were indicated in its label. In a re-evaluation of Ritalin, the FDA reported in 1970 that the longest study of efficacy and adverse effects in children was 6 weeks in duration. Breggin well defines the bottom line: ÒHistory indicates that Ciba is as honest in its claims as the FDA forces it to be. Even if the FDA had the requisite political courage, the agency does not have the resources to keep on top of the drug companies to ensure their honesty in promoting their products.Ó (p. 228)

According to a recent study, the quality and quantity of safety reporting in drug trials is Òlargely inadequate. " In an evaluation of 7 medical areas, Ioannidis & Lau ( 2001), found that researchers who publish their results in medical journals often devote more ink to their academic affiliations than they do to explaining the nature and severity of a drug's side effects. The compromised nature of clinical psychopharmacology research is increasingly well known (Jacobs, 1996; Duncan et al, 2000). The FDA today does not function to keep drug companies honest, especially in recent years. As David Willman reports (2001), the FDA has obeyed former President ClintonÕs urging that FDA leaders trust industry as Òpartners, not adversaries.Ó The policy emphasis is not on defending the public against dangers by putting the burden of proof on the drug manufacturers; rather, the emphasis is on getting drugs approved as quickly as possible. Willman quotes retired FDA medical officer, Dr. Rudolph Widmark: ÒIf you raise concern about a drug, it triggers a whole internal process that is difficult and painful. You have to defend why you are holding the drug up to your bossesÉYou cannot imagine how much pressure is put on the reviewers.Ó The failure to enforce reporting requirements of adverse reactions during clinical trials has led to the approval of drugs that caused harm--and preventable deaths--to thousands of consumers. Willman reports on just seven drugs that were withdrawn after reports of deaths. A review of adverse reaction reports filed with the FDA on those seven drugs showed they were cited as suspects in 1,002 deaths. Keep in mind that experts such as Brian Strom, chairman of epidemiology at the University of Pennsylvania, believe the reports represent as few as 1 to 10 percent of all such events. This means that the 160 above-mentioned reported Ritalin-related deaths actually represent up to 16,000 deaths.

There are, of course, many other psychiatric drugs besides Ritalin now being prescribed to children. The story on FDA approval and monitoring of Prozac (and its family of related so-called SSRIs such as Paxil, Zoloft, Luvox and Effexor) reveals a clearly inadequate and highly suspect approval process; 6-week trials were judged sufficient. Peter and Ginger Breggin (1994) tell about the nefarious conflicts of interest and suppression of truth in the story of Eli Lilly, the FDA and Prozac. Ann Tracy (1994) systematically details the dangers of these drugs. In a 1999 addendum to her book, she reports that the latest FDA figures show Prozac has about 44,000 adverse reports, including 2500 deaths with the large majority of them linked to suicide or violence. Despite this disturbing evidence, the number of antidepressant prescriptions for children continues to soar, reaching 1,664,000 in 1998. (Huffington, 1999)

It is also becoming common practice in this country to put our toddlers on psychiatric drugs. Clinical Psychiatry News (July, 1998) revealed that in MichiganÕs state and federally funded Medicaid Program more than half of children 3 years old and under (infants and toddlers), diagnosed with ADHD, are receiving "a large array of psychotropic medications." Five were less than one year of age; 5 were one year old; 50 were 2 years of age, and, 163 were 3 years old. The dangerous yet customary psychiatric practice of so-called polypharmacy is not limited to our older children. A number of these Michigan preschoolers were ÔtreatedÕ with more than one psychotropic medication. Twenty-two (22) different psychiatric drugs were prescribed. Ritalin and Tenex were prescribed most often. Others were Dexedrine (d-amphetamine), Prozac, Pamelor, Aventyl , Effexor, Wellbutrin, Zyban, Lithobid, Lithostat, Risperdal, and Restoril. More than 33% of those medicated got 2 or more drugs! A recent article in the Journal of the American Medical Association corroborates this report (Zito et al, 2000).

That psychiatric drugs were never tested on children is not really the issue. As Peter Breggin (2000) reports, our National Institute of Mental Health (NIMH), in collaboration with the drug companies, is all too eager to jump into clinical drug studies for children. Everyone should know that the breaking news that large numbers of our little ones are on these toxic drugs does not raise an alarm of protection from psychiatryÕs best, only a cry for the need to fund research on these babies. The NIMH Preschool ADHD Treatment Study (PATS), designed to give amphetamines-Ritalin included- to children 2 years old has just begun. Dr. Fred Baughman is a retired neurologist who writes and speaks extensively on the issue of informed consent and the psychiatric drugging of children. In a letter to the editor of Science (1-26-01), Baughman responds to PATS with the determined outrage that all doctors who really care about children would do well to emulate: ÒShould the NIMH go forth with the drugging of normal infants, toddlers and preschoolers, existing laws should be invoked and criminal charges should be brought.Ó

False Information About The Condition To Be Treated

Given the way our drug approval process works, it is probably fair to say that all drugs on the market should be considered experimental. This is most definitely true for psychiatric drugs. The array of effects, short and long-term, are unceasingly revealed over time. The tragic story of Tardive Dyskinesia, the neurological disease epidemic unleashed by the neuroleptics (Breggin, 1991), is one of many that can be told about psychiatric drugs. The story of Prozac violence against self and others is another story still in the making (Tracy, 1994).

At least in the case of drugs approved for non-psychiatric treatments, however, evidence for the condition to be treated has been confirmed by physical medical testing as consistent with some sort of objective marker previously described in the scientific literature. This is patently not true of so-called mental illness. The legal obligation under informed consent is to provide the patient with all the information relevant to their decision-making--not just about the treatment in question, but also about their condition. It is the opinion of these authors that to say or even imply that what the patient has is biologic and a disease when there is no such proof (as in all psychiatric 'diseases') is conscious deception and abrogates informed consent. That this has become the 'standard of practice' in psychiatry does not excuse it. The abrogation of informed consent is de facto medical malpractice.

Psychiatric patients are never told that their alleged disease is theoretical or metaphorical. This is true of all standard psychiatric diagnoses of children. Regarding the most popular diagnosis, the final statement of the NIH ADHD Consensus Conference Panel (November 18, 1998) read: " ...we do not have an independent, valid test for ADHD, and there are no data to indicate that ADHD is due to a brain malfunction."

When a child is diagnosed according to the strictly behavioral criteria of the Diagnostic and Statistical Manual of the American Psychiatric Association, observation of these ÒsymptomsÓ in no way prove that ADHD is a disease. Furthermore, these ÒsymptomsÓ are not even reliable as behavioral observations. To be reliable, people must agree that a child has "ADHD." A recent article (Mota & Schachar, 2000) shows that the diagnosis is very unreliable. Many children who are supposed to be ADHD are not identified, and many children who are identified as not having ADHD are identified as having it. This means that research done to support the identification and treatment of ADHD that uses the DSM-IV definition totally lacks support. It also means that no medical person correctly diagnoses ADHD. ADD and ADHD are politically manufactured concepts, created by committees of the American Psychiatric Association. ADD was created in 1980, ADHD in 1987. The plain truth is that they are not real diseases in any legitimate scientific meaning of the term disease. To declare otherwise is not medicine; it is fraud.

Pragmatics and Power

Perhaps the biggest practical factor is simply that parents and teachers and children are under a variety of stressful demands, and feel these most acutely when things seem to be going awry. Teachers are under pressure to manage their classrooms and to produce results. Parents are under economic pressures, and their self-esteem is at risk when their children are seen as a problem. They feel the pressure, overt or covert, to do something about their child. It is currently common practice to query resistant parents with, ÒIf your child had diabetes, you would give them insulin, wouldnÕt you?Ó Children feel enormous pressure and shame when they are labeled as a problem. Everyone is vulnerable, and at vulnerable times, individuals desperately need to trust and rely on others for help. Parents often feel like their only hope is to trust the wisdom and guidance of the professionals to whom they turn for help. It is all too easy for everyone involved to grab onto the idea that a child has a medical illness that explains their problems and can be treated with Òmedicine.Ó This absolves everyone of responsibility, and the possible anguish of felt guilt and blame. Underlying this veneer of medical benevolence is the harsh reality that it often appears easier for adults to suppress a child with drugs, rather than face the challenging task of transforming themselves and their institutions in a way that really meets the need of that child.

Psychiatry and psychopharmacology do not rest on rigorous research and valid findings, and the mental health system does not really address the needs of those it is intended to serve (Breeding, 1996, 2000b; Breggin, 1991; Colbert,1996, 2000). Cohen & Jacobs (2000) offer a wonderfully informative model consent form for psychiatric drug treatment, with the caveat that, ÒWe are inclined to think that no one who was so informed would consent.Ó Their model form is highly recommended for its direct and fairly comprehensive description of the truth about psychiatric drug use. This article concludes with a model form in the spirit of Cohen and Jacobs; it is a highly condensed summary of the plain truth about psychiatric drugs and children.

A Condensed Model Consent Form

I understand that my child has been assigned a DSM-IV diagnostic label, based on my doctorÕs (and perhaps others) subjective observation of my childÕs behavior. I am aware that there is no medical evidence that my child has a medical problem, and no scientific evidence that proves the existence of the illness which my child is said to have.

I am aware that I will never be able to remove this diagnostic label or any other from my childÕs medical record, and that this record may interfere with possible educational and vocational directions of my child. I have been informed that the drug or drugs my doctor is prescribing for my child cannot cure whatever ÒillnessÓ or Òchemical imbalanceÓ this doctor may believe my child to have, but can only affect Òsymptoms.Ó I understand that psychiatric drugs have not been demonstrated to have long-term positive effects on any measure of learning, behavior or social development in children.

I understand that the review and approval process of psychoactive drugs by the FDA is both controversial and complicated, and that, therefore, all psychiatric drugs must be considered experimental. I have been informed of all the known effects of any recommended drug, and I have a copy of the current information listed on these drugs in the Physicians Desk Reference. I also am aware of the up-to-date accumulation of FDA adverse reaction reports of any prescribed drug; I understand that it is necessary to multiply the number of reported reactions by up to 100 to estimate the actual incidence of these reactions. I understand that these drugs are addictive and create dependency, and that drug withdrawal can pose serious problems.

I understand that taking psychiatric drugs may cause severe pain and discomfort to my child, worsen my childÕs condition, or even cause my child permanent damage or death. I also understand that no body of research clearly shows that the problems indicated by my childÕs diagnosis require or respond more favorably to drug treatment than to one or more forms of nondrug treatment.

I understand that this brief statement is only the Òtip of the icebergÓ regarding psychiatric diagnosis and drug treatment of my child, and that it is my responsibility to take the necessary time and trouble to fully research the relevant necessary information in order to make an informed decision on behalf of my child.

I understand that since psychiatric diagnosis and drug treatment of children is considered customary and usual medical practice, doctors are generally not held liable for harm resulting from such treatment. Therefore, I understand that the effects of such treatment are, practically speaking, my complete responsibility as a parent.

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