Book Review

The Handbook of Psychopharmacology Trials: An overview of scientific, political, and ethical concerns

N Engl J Med 1998; 338:205-206January 15, 1998

Article

The Handbook of Psychopharmacology Trials: An overview of scientific, political, and ethical concerns
Edited by Marc Hertzman and Douglas E. Feltner. 454 pp. New York, New York University Press, 1997. $75. ISBN: 0-8147-3532-0

Psychopharmacology trials have gone through a big boom in the past 10 years. According to a recent list, there are 294 products that act on the central nervous system in the worldwide pharmaceutical pipeline, and approximately 40 percent of them are psychopharmacologic agents for psychiatric disorders. Therefore, it would be important and timely to recommend a definitive book in this area. This is not the definitive book, however. Some chapters are worth reading, but I did not like others. For readers interested in the scientific aspects of psychopharmacology trials, Clinical Evaluation of Psychotropic Drugs: Principles and Guidelines, edited by R.F. Prien and D.S. Robinson (New York: Raven Press, 1994), may be a better choice. The handbook under review is subtitled “An Overview of Scientific, Political, and Ethical Concerns.” I was very interested in reading the chapters dealing with the political and ethical concerns. But to my disappointment, these chapters were the ones that I did not like.

Most of the chapters on scientific issues that review a specific syndrome or disorder are interesting, are well written, and reflect the limitations of clinical trials in that area. I cannot say the same for the “nonscientific” chapters. The first chapter that reviews the importance and history of psychopharmacology trials has two important and unforgettable errors: lithium was introduced in Europe by Danish investigators, rather than Dutch investigators; and monoamine oxidase inhibitors were the first successful antidepressants used, rather than the tricyclic antidepressants. The author of this chapter and any reader interested in the history of psychopharmacology trials are referred to Discoveries in Biological Psychiatry, edited by F.A. Ayd and B. Blackwell (Philadelphia: J.B. Lippincott, 1970).

I found the chapter on the ethics of psychopharmacology trials particularly disturbing. It is written by a philosopher who follows the antipsychiatry tradition and continues to warn us of the danger of overtreating normal people or the “social deviants” who do not want treatment with psychotropics or psychotherapy, but he does not grasp the real problems of treating severe mental illness. This issue does not appear to me to be the most important ethical dilemma in clinical trials, since I am not sure that psychotherapy or even pharmacotherapy can be forced effectively on social deviants against their will or even that these treatments are terribly effective in this group of people. One would like to find discussions of the ethics of the lack of psychiatric treatment for people with severe mental illness and its terrible human costs (homelessness, suicide, and so on). In my opinion, this is the most important ethical issue.

We have many treatments (medications and psychotherapy) for severe mental illness that have proved to be effective in clinical trials, but they are not used or they have limited effectiveness in the real world because of legal issues and problems with access to them. All studies show that severe mental illness is underdiagnosed or misdiagnosed and undertreated. Moreover, psychiatric treatments that have been proved to be effective in clinical trials are restricted for economic reasons. Nobody would dare to restrict access to a drug that costs $5,000 to $9,000 per year to treat diabetes mellitus, but new medications to treat schizophrenia are restricted by states or the Department of Veterans Affairs because of their cost. The striking and paradoxical fact is that these new drugs may save as much money as they cost (or even more) because they increase compliance and reduce hospitalizations. The great ethical question, in my opinion, is why psychiatric patients are not receiving treatments that clinical trials have shown to be effective.

I found the chapter written by a politician to be a one-sided view, focusing only on the excessive profits of the pharmaceutical companies; a rebuttal by an industry representative may be needed, perhaps focusing on the disturbing effects of the politicians.

I do not recommend this book as the definitive publication on psychopharmacology trials. However, it may be a good idea to check it out from the library to review the state of the art of some psychopharmacology trials (e.g., those of treatments for aggressive behavior, relapses in alcoholism, and eating disorders) or some thought-provoking chapters (such as those on the “blindness” of double-blind studies, clinical trials in women, and psychopharmacology and psychotherapy).

Jose de Leon, M.D.
University of Kentucky College of Medicine, Lexington, KY 40508