What if Psychotherapies Had to Meet FDA Standards for Effectiveness, Safety, Appropriateness?
Al Siebert, PhD
(Rejected for publication by The American Psychologist as too controversial.) Revised, May, 1996
Efforts are being made by the U.S. Senate to establish Food and Drug Administration (FDA) criteria for psychotherapy by requiring that it be effective, safe, and appropriate. This along with Congressional mandates that Health Maintenance Organizations and health insurance companies provide more funding for psychotherapy, brings attention to evidence that psychiatric and psychotherapy practices at best get approximately the same results as placebos and at worst are ineffective, harmful, and inappropriate.
The possibility of imposing standards for psychotherapy that are comparable to the standards the FDA has established for drugs and drug therapy, raises major issues about psychotherapy, including the possibility that some psychotherapies and the treatment of schizophrenia could be banned.
An important hidden issue is that the social and legal systems in the United States have created a situation in which every person can be diagnosed as having symptoms of mental illness. Also, no psychiatrist in the history of U.S. law has ever been adjudicated to have made a mistake in diagnosing a person as mentally ill and be required to pay damages.
Psychotherapists attempting to gain authorization from Congress for third-party payments of psychotherapy have stirred up problems for themselves. By drawing attention to their practices, some psychotherapists could be banned from doing psychotherapy and, along with psychiatrists, could be prohibited from attempting to treat people believed to have schizophrenia.
Psychotherapists have tried for many years to get the U.S. Congress to revise the Medicare act so that people qualified for Medicare could go to psychotherapists in private practice and have the government pay the treatment expenses. Members of Congress have repeatedly refused to pass such legislation, however. While sympathetic to the needs of people on Medicare, they have too many doubts and questions about psychotherapy (Inouye, 1983; DeLeon, VandenBos, & Cummings, 1983; Perry, 1983). The 97th Congress, like previous Congresses, did not vote for desired approval for third-party reimbursement for psychotherapeutic services but it did take a significant action. It developed a declaration of purpose and specified essential criteria for psychotherapy:
In order to assure that professional mental health services for which payment may be made under this Act (the Social Security Act, Medicare provisions) are efficacious, safe, and appropriate to the patient's need, and in recognition of the interests of patients, the public, mental health specialists, and providers in improved mental health care, it is the purpose of this part to assure that the professional mental health services for which payment may be made under this Act conform to appropriate professional standards. (S.647 [97th Congress] Sec. 1180) (Perry, 1983).
The problem this declaration of purpose created for psychotherapists is that they must deal with evidence that current professional standards allow and protect psychotherapies that are not efficacious, safe, or appropriate. A look at each of the three criteria raises the following issues about psychotherapy:
Is It Effective?
Klerman advocates the adoption of a policy of effectiveness for psychotherapy which would be similar to the policy mandated by Congress when the Federal Drug Administration (FDA) was established in 1962. The FDA was instructed to develop criteria for efficacy and to use these criteria to review both new drugs and all drugs approved prior to the passage of the 1962 Act (Klerman, 1983).
The problem for psychotherapists is that, if a criterion and policy for efficacy similar to that used by the FDA for drugs is established for new and already existing psychotherapies, then most psychotherapy as currently practiced would have to be banned by the regulating agency. Here's why:
Title 21, Chapter One, Section 312.1 of Food and Drug Administration policies, establishes that a plan for clinical trials using treated subjects and control subjects must show that the effects and results obtained must be attributable to the drug under investigation. As explained by FDA Associate Commissioner Pines (1981), "the investigator must have a basis for determining that the drug is causing the desired effect, rather than other variables, or chance" (p. 2).
Thus for a new drug to be approved or an old drug allowed to continue to be marketed, there must be convincing evidence that the same result could not be obtained by any other means. Such efficacy is typically established in double-blind experiments in which neither the physicians nor the patients know if the medication given is the real drug or a placebo. In other words, efficacy is established by proving that the drug gets significantly better results than a placebo.
Hence the problem for psychotherapists if an efficacy standard similar to that developed by the FDA is adopted. Most of the psychotherapy research over the years has reported an effectiveness level no better than that achieved by placebo conditions. In fact, Smith, Glass, and Miller (1980), in their widely publicized book about psychotherapy being beneficial, include "Placebo Treatment" as one type of psychotherapy (p. 89). Although Smith, et al. state that placebo treatments are slightly less effective than specific psychotherapies, Prioleau, Murdock, and Brody (1983) report that in the Smith et al. meta-analysis there were only 32 studies in which psychotherapy with real patients was compared with placebo treatment, and that in these 32 studies "there is no evidence that the benefits of psychotherapy are greater than those of placebo treatment." (p. 275)
The basic issue here is that the professional standard for many psychotherapists is to accept an efficacy criterion which is no better than the placebo effect. If an efficacy standard similar to what the FDA has established for drugs is adopted, in which both new and existing treatments must be proven to have more effect than placebo treatment, what will be the consequences for psychotherapists?
Is It Safe?
Research reports into the outcomes of psychotherapy and psychiatric treatment seldom draw attention to the harm done to some patients by their therapists. Smith, et al., for example, spent two years intensively studying 475 published reports of psychotherapy outcomes and claim that "there is scant evidence of negative or deterioration effects of psychotherapy." (p. 124) Anyone who has worked in clinical settings, however, knows that some patients are harmed by psychotherapeutic efforts. (Stuart, 1970; Strupp, Hadley, and Gomes-Schwartz, 1977; Szasz, 1970, Zilbergeld, 1983)
Rogers, Gendlin, Kiesler, and Truax (1967) specifically state, in reporting the findings of the Wisconsin psychotherapy study, that "therapy must...bear the onus of contributing to the deterioration of some of the patients. If this is the case, then this study provides evidence of the harmful as well as the salutary effects of psychotherapy. Therapy, it seems, should no longer be viewed as either helpful or safely benign." (p. 333)
Psychiatrist Manfred Bellak (1979) concluded toward the end of his career that "what used to be considered pathogenic 'schizophrenic regression' is probably largely 'iatrogenic.' Patients were isolated from the families and communities in which they lived, held in wards with perceptual isolation and sensory deprivation and suffered from disuse atrophy of their ego functions. A sense of hopelessness was fostered in institutions run in a poor and dictatorial fashion by an ill-trained staff....Acts of sadism were tolerated, if not encouraged. Visiting privileges were limited. Telephone privileges rare, and all mail was censored."
Evidence that mental patients have been seriously harmed in psychiatric facilities and that a serious social injustice exists is seen in the spontaneous formation of dozens of volunteer groups organized to combat, stop, and change the existing mental health system (Note 1). These groups have formed a loose national network, hold a national convention each year, and organize demonstrations at the American Psychiatric Association conventions.
Libraries and book stores contain many accounts by ex-mental patients attempting to tell the world about their distressing experiences. Judi Chamberlin (1978), for example, writes "Many ex-patients are angry, and our anger stems from the neglect, indifference, dehumanization, and outright brutality we have seen and experienced at the hands of the mental health system. Our distrust of professionals is not irrational hostility, but is the direct result of their treatment of us in the past. We have been belittled, ignored, and lied to. We have no reason to trust professionals, and many reasons to fear them" (p. xiv).
The illusion that psychotherapy is safe stems in part from the low risk psychotherapists have about malpractice lawsuits. The risk of a malpractice lawsuit is so low that many psychotherapists do not even bother with such insurance. Those who do take out malpractice learn that they qualify for the very lowest rates.
Are the risks and rates low because psychotherapy is safe?
The risks and rates are low because there is not one case in the history of United States law in which a psychiatrist or psychologist was found to have made a mistake in diagnosing a person as mentally ill and required to pay damages for harm and suffering caused by the mistake. This is an extraordinary statistic considering the fact that for many decades approximately one-half of all the hospital beds in the nation have been occupied by persons diagnosed as mentally ill. (Knight, 1952; American Psychiatric Asociation, 1996)
Why has there never been one adjudicated error in the diagnosis of mental illness in the entire history of psychiatry and clinical psychology? Because the standard of practice is to regard every human as mentally ill to some extent. This way of thinking is derived from Sigmund Freud who believed that every human has some psychopathology. Freud (1937) declared that in reality no one is "normal." He called "normality in general an ideal fiction" and said that "every normal person is only approximately normal: his ego resembles that of the psychotic in one point or another, in a greater or lesser degree..." (p. 337).
Two psychiatrists highly influential in the development of American psychiatry and the development of laws governing commitment procedures, William and Karl Menninger, were strongly Freudian. They echoed Freud's views that every person is at one time or another mentally ill (Menninger, 1948; Menninger, 1964).
A scientific study which helped prove how extensively mental illness is believed to be present in the population is The Midtown Manhattan Study (Srole, et al., 1962). This study reports the results of an extensive research project designed to assess the mental health of Americans. Experienced researchers using good sampling techniques had 1660 adults (ages 20-59) interviewed in their homes and evaluated by psychiatrists.Table 1 Home Survey Sample (Age 20-59) 18.5% Well 36.3% Mild Symptom Formation 21.8% Moderate Symptom Formation 13.2% Marked Symptom Formation 7.5% Severe Symptom Formation 2.7% Incapacitated
About the people in the "Well" category, the authors of the project state, "In Table 8-3 we see that roughly 1 in 5 (18.5%) respondents were viewed by the team psychiatrists as free of other than inconsequential symptoms and can be regarded as essentially Well" (p. 138). Thus the authors of this scientific study, using accepted research techniques, did not find one person to be without mental illness.
No psychiatric articles disagreed with the study's findings nor has any research published since then negated any of the findings. DeLeon, VandenBos, and Cummings (1983), for example, have observed that "mental health providers can present a rationale for why any person could, or should, be seen in psychotherapy" (p. 909).
In regard to the criterion of safety, therefore, there are two issues which must be addressed:
Why should Congress should mandate funding for psychotherapy for persons covered under Medicare and in Health Mainenance Organizations when the professional standards of psychotherapists can justify therapy for every person covered?
A more compelling issue, however, is about patients' rights in cases of malpractice. How can a patient ever collect damages for harm stemming from a wrong diagnosis when the current professional standards are that no professional ever makes a mistake in diagnosing a person as mentally ill?
Is it Appropriate?
The criteria of appropriateness is intended to establish that, when a person presents a specific pattern of symptoms, a therapist will be able to state what the recommended course of treatment is for such a condition, how long it will take, what the risks are, and what the expectations of success are. What is desired for a person considering psychotherapy is the same sort of information a person with a physical illness or disease can expect to receive from a physician.
The present standards in psychotherapy, however, are that the theoretical background and beliefs of the therapist frequently determine the nature of the therapy more than the symptoms of the patient or client. The present standards in psychotherapy are such that many therapists are reluctant to give a definitive diagnosis or prediction of outcome.
That psychotherapists cannot, with much confidence, state what therapy will work under which circumstances is highlighted in the conclusions reached by Smith et al. (1980). They state:
"Differences in how psychotherapy is conducted (whether in groups or individually, by experienced or novice therapists, for long or short periods of time and the like) make very little difference in how beneficial it is....Apparently, little that the therapist controls bears any strong relationship to the benefits of psychotherapy. The method of psychotherapy counts for little; nor do the gross features of therapy as its length, whether it is administered in groups or alone, or the training and experience of the therapist...The possibility ought to be considered more seriously that the locus of those forces that restore and ameliorate the client of psychotherapy resides more within the client himself and less within the therapist and his actions. (Smith, et al., p. 188)
The criterion of appropriateness raises questions about what could happen if FDA level standards were imposed onto the practice of psychotherapy. An important issue here is why Congress should mandate funding for a long and more costly psychotherapy when any shorter and less costly therapy will get approximately the same results.
At another level, a question must be raised about whether some psychotherapies would be banned if an FDA level standard of effectiveness would be legislated.
Should Treatment of Schizophrenia Be Prohibited?
Research about shizophrenia published in the psychiatric literature has not established that shizophrenia is a disease or illness (Siebert, 1996). In fact, ample evidence exists indicating that if the Senate mandated criteria for efficacy, safety, and appropriateness were enforced, then psychiatrists and others would be banned from efforts to treat schizophrenia.
Psychiatric practices are widely known to be ineffective, harmful, and inappropriate. The eminent psychiatrist Werner Mendell, for example, has written:
In the post-World War II literature, there are many examples of patients who went to state hospitals incorrectly diagnosed either as schizophrenic or mentally retarded and who stayed for thirty of forty years only to be discovered, during the renaissance of psychiatry after World War II, not to be ill at all. These patients show a psychological condition based entirely on having been in the hospital for thirty or forty years without any initial mental illness or mental retardation. (Mendell, 1981)
If Congress looks closely at this situation, it is possible that Congress will consider prohibiting the efforts to cure people of schizophrenia. Certainly some changes will eventually be made in those social, legal, and professional practices which both permit the use of police powers to force thousands of people into involuntary treatment and at the same time make it legally impossible for any mental health practitioner to be adjudicated to have made an error in diagnosing a person as mentally ill nor required to pay damages from acknowledged harm.
Discussion and Conclusion
Congressional action mandating more funding for psychotherapy is in conflict with an earlier Senate resolution establishing criteria that psychotherapy must be effective, safe, and appropriate and portends difficulties for psychotherapists. Psychotherapists have been justifying their actions on the basis of good intentions and have avoided attention to the consequences of their actions. The period ahead would go easier if psychotherapists would, as a group, engage in the sort of candid, honest, albeit sometimes painful, self-examination that they encourage their patients to undertake.
Such a prospect is not likely, however, because mental health professionals, in general, are inclined to demean and ignore anyone who attempts to focus their attention on unpleasant information about themselves. Psychiatrists, for example, have refused to give any serious attention to the many efforts by psychiatrist Thomas Szasz to show his professional colleagues that many of their practices are harmful to patients. Psychiatrists have responded by attacking his character, and they regard his efforts as harmful (Kubie, 1974; Marmore, 1976). Jonas Robitcher, in commenting about the various ways in which psychiatrists have reacted negatively to Szasz, says:
Although Szasz is perhaps America's most famous psychiatrist, he has received no rewards or recognition from the American Psychiatric Association or other mainstream professional groups. In spite of his exposure of a multitude of psychiatric abuses and his recording of case histories demonstrating the dangers of too great of reliance on psychiatric authority...he is usually denigrated or ignored. He has antagonized psychiatrists beyond redemption by his insistence that there is no mental disease (p. 111).
The main problem is that mental health professionals are not good examples of mental health. As a collective they show too many signs of having drifted into "groupthink" (Janis, 1972) for there to be much chance that they will be able to self-initiate changes to their deeply ingrained practices that are not effective, safe, or appropriate. It seems likely that changes will come only from outside requirements by legislation, regulatory agencies, and health maintenance organizations.
1. A partial listing of groups known to be organized against psychiatric practices includes:
Bay Area Committee for Alternatives to Psychiatry, Madness Network News, Mental Patients Liberation Movement, Network Against Psychiatric Assault, Psychiatric Inmates Rights Collective, League Against Criminally Oppressive Psychiatry, Mental Patients Rights Association, Advocates for Freedom in Mental Health, Americans Against Psychiatric and Psychological Abuse, Coalition to Stop Institutional Violence, Mental Patients Liberation Front, Justice in Mental Health Organization, Psychiatric Alternatives Alliance, Project Overcome, Mental Health Advocates Coalition, Madness Advocacy and Defense, Psychiatric Advocacy and Rights Association, ACT/Action, Mental Patients Alliance of Central New York, Mental Patients Rights Project, Alliance for the Liberation of Mental Patients, Society for the Preservation of the Rights of the, Emotionally Distraught, American Association for the Abolition of Involuntary Mental Hospitalization, Inc.
For a complete listing of the groups and their addresses write to: Madness Network News, PO Box 684, San Francisco, CA 94101; National Mental Health Association, 1800 North Kent Street, Arlington, VA 22209.
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