"A Model Consent Form for Psychiatric Drug Treatment"

1. Introduction

The model consent form which appears below was first developed in 1991. It was included in a package of information and advocacy material that David Cohen prepared for a group of current and ex-psychiatric patients attending his workshops on psychiatric drugs. The purpose of the form was to summarize, from a critical perspective, some information about psychiatric drugs and the context of their prescription which might make prospective consumers more knowledgeable. Most of the patients and ex-patients who read it said that not a single point mentioned on the form was ever discussed with them by their prescribing doctor.

The original version was written in an ironic tone, to make it an entertaining read while trying to impart scientifically validated information. Over the years, as it included recent evidence, as colleagues asked to use it in their own practice, and as others suggested ways to modify it, the tone became more factual. Traces of irony probably remain but do not intend any belittling of drug prescribers or drug users.

Typically, consent forms used in many helping interventions (medical or otherwise) serve to protect professionals, not inform and empower clients to make intelligent decisions about their own fate and well-being. If it seeks to achieve the latter goal, we believe that informed consent for psychiatric drug treatment should contain the following elements:

- a statement to the effect that the biomedical status of what is to be treated is uncertain, even speculative;

- unbiased, up to date information concerning treatment options, including of course strictly psychological forms of treatment;

- realistic and comprehensible information concerning the somatic and psychological effects of drug use and drug withdrawal, both in the short run and in the long term.

We are inclined to think that no one who was so informed would consent. Of course, this is an exceedingly complex question. It would be greatly simplified if psychiatry and clinical psychopharmacology rested on rigorous research and valid findings, showed genuine concern for the patient's or subject's best interests, and operated in a mental health system designed to meet patients' or clients' needs. We have argued elsewhere in detail that this is not the case (1-3). If our analysis has any validity, no consent form will do. Nevertheless, therapists, clinicians, or researchers must obviously make a sincere effort to convey the risks, the drawbacks, the unknowns of psychiatric drug treatment - even if many prospective patients might understandably recoil.

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2. A model consent form for psychiatric drug treatment

I, the undersigned, understand that I am about to be prescribed one or more drugs by Dr. ___________. The drug(s) I am to be prescribed is (are) the following: ___________________________.

I understand that a DSM-IV diagnostic label has been assigned to me, based on my doctor's (and perhaps also on other people's) subjective judgement of my speech, manner, and behaviour during our meeting, which lasted approximately _______ minutes. I am aware that I will never be able to remove this diagnosis, or any other that will be added in the future, from my medical record.

I understand that although my doctor says that I am sick or that I have a treatable illness or disease, he or she is just using a figure of speech and cannot establish, with any test or procedure known to medical science that I in fact "have" the "illness" implied by the diagnostic label. Indeed, I realize that although medical opinion may now hold that a "chemical imbalance" or a "brain abnormality" or some physical problem "underlies" or "produces" my distress or suffering, I am aware that no objective information (through lab tests, scans, etc.) concerning the state of my body has been obtained in order to arrive at a DSM-IV diagnosis. If by chance such information has been obtained for that purpose, I understand that it played no role whatsoever in fulfilling any criteria for the DSM-IV diagnosis or diagnoses that I have been given by my physician - except perhaps for diagnoses related to drug-induced disorders such as tardive dyskinesia.

I have been informed that the drug or drugs which my doctor is prescribing cannot cure whatever "illness" or "chemical imbalance" medical opinion might believe I have, but only affects symptoms of my distress or suffering.

I understand that the drug I am about to take cannot restore any of my physical or psychological functions "back to normal". Rather, the drug is expected to produce many new mental and physical symptoms, which might help make my original complaints seem less disturbing for a while.

I understand that it is exceedingly difficult to determine what is brought about (both desired and unwanted) by a psychoactive drug which has wide and diverse effects on the brain and other organ systems. I further understand that the problem of how to accomplish this adequately is a controversial issue within psychiatry and the Food and Drug Administration (FDA).

I realize that FDA approval of the drug I am about to take is based upon very short-term studies (usually 6 to 8 weeks) which are designed, paid for, and supervised by the drug's manufacturer. I further realize that the FDA does not require or expect that all of a drug's adverse effects will be known prior to marketing and prior to lengthy exposure of ordinary patients to that drug. I am also aware that the FDA's knowledge about the drug's adverse effects after marketing comes mostly from spontaneous physician reports, even though the FDA itself recognizes that these reports are just "the tip of the iceberg" of the probably true frequency of adverse effects.

I know that wording in the package insert and in the Physician's Desk Reference is the outcome of a complex negotiation between the manufacturer and the FDA. I also realize that it sometimes occurs that the FDA belatedly learns that the manufacturer did not fully disclose what it actually knows about a drugs' adverse effects. Finally, I understand that despite FDA approval for psychiatric drugs being granted on the basis of short-term studies, the long-term effects of continuing drug use is not systematically studied by any responsible organization or government agency.

If I am consenting to take the drug as part of a research study, I understand that the researcher's primary interest and loyalty is not to me as a patient, not to my personal interests or welfare.

I understand that the "needs of the research project" come before and have priority over my own personal needs. I understand that the drug will have a wide range of effects on my brain, body, consciousness, emotions, and actions. My sleep, my memory, my judgment, my coordination, my stamina, my sexuality are likely to be affected. I understand in particular that the effects of a psychoactive drug may undermine my ability to monitor and report upon just how the drug has affected me, even impaired me, perhaps in a dangerous direction (judgment, social perception, impulse control, etc.). I further understand that what to do to protect me, as a patient or subject, against this possibility is a basically unanswered problem in psychiatric drug treatment and research."

I understand that effects that have a 1 in 100 chance of occurring are actually considered "frequent" effects that should be mentioned to an adult, competent, prospective patient like myself. My doctor (or the researcher) has specifically advised me that the following toxic or adverse reactions may occur, and has provided these estimates of the frequency of their occurrence in patients like myself: _______________. I understand that I may experience an adverse effect which might then abate after a few days or weeks. This will usually mean that my body has developed a tolerance to the drug's presence, not that the effect will never bother me again in the future.

I understand that if I inform my doctor of the occurrence of adverse effects, he or she will have five basic options: (1) cease the drug, (2) decrease the dose, (3) increase the dose, (4) switch to another drug, (5) add another drug. I understand that no rules exist to determine which option is best to follow in individual cases, and it is likely that several options will be followed simultaneously. I also understand that most doctors are not likely to report to the FDA any adverse effect they suspect or have observed, contributing to the generally inadequate picture of a drug's true impact on patients like myself.

I have been informed, if I am prescribed a neuroleptic drug such as Haldol or Risperdal and if I take it regularly for a few years, that I have at least a 30% chance over the next 5 years of developing tardive dyskinesia, a possibly irreversible disorder characterized by abnormal involuntary movements of my face or other body parts. I have been informed that I may also suffer from other acute or chronic movement problems, such as parkinsonism, akathesia, and dystonia, and their associated unpleasant mental states.

I have been informed, if I am prescribed a tranquilizer like Xanax or Klonopin and I take it regularly for more than three or four weeks, that I run the risk of becoming physically dependent on it. I will then have a good chance of experiencing "rebound" insomnia and anxiety, and many other unpleasant sensations, when I try stopping the drug, or even while I continue to take it. I understand that these drugs are not effective anti-anxiety or sleep-inducing agents after a few weeks of use. I realize that some people are unable to withdraw and must therefore permanently endure the consequence of daily use.

I have been informed, if I am prescribed lithium, that I do not have a "lack" of lithium in my body, nor can such a "lack" be demonstrated by any existing test. I understand that the blood tests that I will undergo regularly will be for the sole purpose of determining just how much lithium has been introduced in my bloodstream and whether this could produce toxic symptoms, since, as a result of the mental dullness that lithium is expected to produce, I will be in no position to recognize some of these toxic symptoms.

I understand that the drug is likely to provoke various unpleasant effects when I stop taking it, especially if I stop too suddenly. I understand that although withdrawal reactions are systematically ignored in psychiatric drug treatment or research, they might represent the worst part of my whole drug-taking episode. I understand further that these reactions will often closely resemble the original symptoms for which the drug was first prescribed to me, and are likely to be taken for a return of these symptoms (a "relapse"), rather than for withdrawal effects. I realize that my doctor, or the researcher, is likely to interpret these reactions as a sign that my "illness" is chronic and that my drug is "effective."

I also understand that once I have been taking drugs for months or years, I will have much difficulty finding a health professional to assist me in withdrawing prudently and safely from the drugs, if I so wish.

Having understood the above, I realize that the drug treatment may cause severe pain or discomfort, worsen my existing problem significantly, or even damage me permanently. However, most doctors or experts will never formally or informally acknowledge that the drug harmed me in this manner. I will have practically no chance of proving that the drug caused my damage and obtaining compensation for me.

I understand that no body of research clearly shows that the problems indicated by my diagnosis or diagnoses require or respond more favourably to drug treatment than to one or more forms of non-drug treatment. It is obvious to me that non-drug treatment would enable me to completely avoid whatever dangers or risks are associated with taking the drug or drugs I am agreeing to take. My doctor (or the researcher) has made it clear to me that existing evidence does not indicate that it is in the best interest to choose drug treatment as a first recourse. I am choosing to be treated with (write the name of the drug or drugs) for the following reasons (provide ample space; this section must be filled in by the patient or subject):

____________________________________________________________

____________________________________________________________

____________________________________________________________

Signed: _______________________________

References:

(1) D. Cohen, "A Critique of the Use of Neuroleptic Drugs in Psychiatry," in "From Placebo to Panacea: Putting Psychiatric Drugs to the Test," S. Fisher and S. Greenberg, eds. John Wiley, New York, 1997, pp. 173-228

(2) D.H. Jacobs, "Psychiatric Drugging: Forty Years of Pseudo-Science, Self-Interest, and Indifference to Harm", Journal of Mind and Behaviour 16 (1995), 421-470

(3) M. McCubbin and D. Cohen, "Extremely Unbalanced: Interest Divergence and Power Disparity Between Clients and Psychiatry", International Journal of Law and Psychiatry 19 (1996), 1-25

This article copied from the "International Journal of Risk and Safety in Medicine," Vol. 11, no. 3, pp. 161-164; Copyright 1998, OIS Press, All rights reserved.