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physician to physician. By definition, such patients are not prevailing upon the first or second physician to provide the drug therapy which they feel is appropriate.

Mr. Mann. In any event, it would be greatly improved by the education and training that you have already alluded to?

Dr. RUCKER. Including the data base that I think is essential for helping to establish some of the characteristics of that problem. There are many constructive steps that one can do to minimize these artifacts that interfere with the attainment of rational prescribing, and my general philosophy is we ought to identify them and minimize them.

Mr. Mann. Thank you very much.
Mr. WOLFF. Mr. Rangel.
Mr. RANGEL. Thank you, Mr. Chairman.

I have heard in the District that a lot of these drugs are being prescribed by the physician, not based on his medical experience, but rather on how good the salesmen are in selling their wares. It's hard to make this accusation against the profession, but is there any evidence to possibly support that the purveyors of the overuse and abuse of drugs are in fact salespeople? In my town I found out that some of the salesmen were practicing surgery, brain surgery, and I just wondered if they were drug pushers.

Dr. RUCKER. May I have the first response ? I have a publication dated March 14, 1977, where the marketing vice president, in explaining why he built up a sales force that numbered 450 people—and I quote the publication—"Our reasoning was simple,” said the vice president, "detailing physicians is the best way to sell drugs. If someone shows me a better way, I will do it, but so far, all I can say is that every time we have added salespeople sales have gone up."

I have to suggest that the reason for adding salesmen is that sales go up. If sales went down, I would suggest that the industry would likely decrease the sales force.

Mr. RANGEL. But what do you suggest that we do to protect the consumers, if the doctor is going to benefit from the profit of the sale and and he's prescribing something that just appears to be popular? Where do we rely on his medical experience and training rather than that of the salesman?

Dr. RUCKER. Do you mean that the doctor would profit economically from these transactions? Because if you do, I don't think that's usually the case. I would think that would probably be rare.

Mr. RANGEL. Well, I hope that I'm wrong, but any number of doctors have all kinds of samples, and it's my understanding that

Dr. RUCKER. That's another dimension. They may trade the samples with the pharmacist for TV sets and clock radios and Kleenex, and who knows what else in between. That's a possibility.

Mr. RANGEL. But some have made that accusation and I have no evidence to support it—they've made it clear that persuading the doctor to adopt a certain brand name medicine could prove economically beneficial to the physician and he could rest assured that he would receive benefits from it.

Dr. RUCKER. That's a possibility, but if you ask me to rank those factors that lead to irrational prescribing, I would put that problem at the 2- to 3-percent level. It's important. It ought to be eliminated. But if we could develop an optimum system for controlling this particular problem as just defined, we would still be plagued with a large irrational prescribing.

Mr. RANGEL. So what you're saying is, as it relates to sales people, is that doctors are subjected to the same type of pressures in the marketing world as anybody else and certainly you couldn't say that's wrong; could you !

Dr. RUCKER. Well, I think there's an optimum way of minimizing irrational prescribing and I'm sorry you weren't here when I outlined that methodology in the form of a national drug foundation where the physician would be provided with objective information that would be appropriate to supporting decisionmaking.

Mr. RANGEL. The American Medical Association doesn't provide that now?

Dr. RUCKER. There are elements of rational information floating around in our society but, as I said in my testimony, it probably takes the diligence of a detective to corral it all and apply it effectively in treating a single patient.

The problem is often one of redundancy. The physician is overwhelmed with information and he can't discriminate because of this problem of redundancy.

Mr. RANGEL. Thank you. Thank you, Mr. Chairman.

Mr. WOLFF. Dr. Rucker, one final question. I believe it was you who cited that 52 percent of the decision making process was influencedMr. NELLIS. It was Mr. Pekkanen's testimony.

Mr. WOLFF. Mr. Pekkanen, would you comment on your statement that 52 percent of the decisions were influenced by the detailmen?

Mr. PEKKANEN. Yes; 52 percent of the physicians who were surveyed said the detailmen had a marked influence on their prescribing habits. I'd like to read a very brief quote from Dr. Leo Hollister who's a nationally recognized psychopharmacologist:

I have personally been chagrined by the fact that even though I am known throughout the country and perhaps even over the world for my work with these drugs, that I have really been less influential in my own hospital on the prescribing habits of physicians than the next detailman that walks in the door.

I think it's clear from the figures from the industry themselves that they put a tremendous amount of emphasis on the detailmen. Perhaps one-half billion dollars a year goes into supporting the detail force nationally, and I think they have a very strong influence. As I talked to one detailman at some length, he said, "You have to be very cautious about your printed material because that's usually checked by the FDA, but when you speak to the doctor personally you have a chance to stretch things a little bit," and I didn't take this as being a criminal act by any means, but he's a salesman and he's trying to get across his product and I think it's very natural for him to want to do that. I don't think the public is served by that, but it happens to be a fact of life.

Mr. WOLFF. We want to thank both of you, Mr. Pekkanen and Dr. Rucker, for appearing before us today and giving us the benefits of your experience and your testimony. Certainly they will help us in better performing our task here through an informed judgment.

Our next panel includes Dr. Daniel X. Freedman, chairman of the department of psychiatry, University of Chicago and member of the American Medical Association; and Dr. Joseph Boyle, a member of the board of trustees of the American Medical Association.

Could I ask you to be sworn? You have already taken an oath as doctors, I'm sure. We're going to ask you to be sworn here today. Do you promise to tell the truth, the whole truth, and nothing but the truth, so help you God?

Dr. BOYLE. I do.

Mr. WOLFF. Would the gentleman who hasn't been identified please identify himself?

Mr. PETERSON. Harry Peterson, director of AMA's Department of Legislation.

Mr. WOLFF. Thank you. Will you please proceed? TESTIMONY OF JOSEPH F. BOYLE, M.D., MEMBER OF THE BOARD


Dr. BOYLE. Mr. Chairman and members of the committee, I am Joseph F. Boyle, a physician practicing internal medicine in Los Angeles, Calif. I am currently a member of the board of trustees of the American Medical Association. Participating in our presentation today is Daniel X. Freedman, M.D., and Mr. Harry Peterson, who is the director of the American Medical Association's Department of Legislation. Dr. Freedman is a professor and chairman of the department of psychiatry at the University of Chicago, as well as the chief editor of the Archives of General Psychiatry of the American Medical Association.

The American Medical Association is pleased to take this opportunity to respond to your letter requesting AMA's views on the prescribing and dispensing of psychotropic drugs in medical practice.

AMA has had a longstanding interest in the use of all drugs and the regulation of drug products. It is a fact that many of the so-called miracles of modern medicine can be directly attributed to the development of new and improved drug products. As this committee knows, the Congress now has before it a number of legislative proposals intended to revise extensively—and in some cases drastically-our current Federal drug law. In order to assure patients continued access to the broadest range of safe and effective drug products, AMA has developed amendments to the Food, Drug, and Cosmetic Act designed to improve the drug regulatory process in the United States. These amendments have been introduced as H.R. 12485 by Representative Tim Lee Carter. We have also been very active in supplying testimony and providing information to the respective House and Senate committees regarding the Drug Regulation Reform Act of 1978, the administration's proposal for revision of the drug law.

Mr. Chairman, we are aware that this committee has centered its attention on what might be termed aberrant or improper uses of psychotropic drugs. It might be well at this time to speak first to the general use of drugs in medical practice.

In treating illness, injury, disease, and other medical conditions, physicians draw upon various treatment modalities in order to ameliorate patient symptoms and, when possible, to effect a cure. Drug therapy, including the use of psychotropic drugs, is just one part of the armamentarium available to physicians in meeting patient needs.

In selecting any course of treatment, the responsible physician examines the patient in order to diagnose the patient's problem. This process usually includes the taking of a complete medical history of the patient, a physical examination, and in some cases diagnostic tests and procedures. The physician then evaluates the data received from the examination with information that he has acquired through formal and continuing medical education, clinical experience, articles published in the scientific literature, consultation with other physicians, current reference texts and, in the case of drugs, the FDA approved labeling for the drug. He then reaches a decision on how to proceed in the particular patient's case. In many instances, this evaluation will lead the physician to choose drug therapy as the most appropriate treatment mode. A psychotropic drug may be selected by the physician when the medical indication for the use of such a drug is present. This examination, evaluation, and selection process constitutes the very essence of good medical practice.

There has been an increasing and understandable concern surrounding the use of psychotropic drugs by the medical profession in the treatment of a variety of medical conditions. By their very nature, psychotropic drugs are drugs that affect the central nervous system. Because of this factor, they can be subject to abuse, and may produce drug dependence. However, even this generalization is not relevant to all psychotropic substances, as Dr. Freedman will discuss. Because of the extent of these risks, the medical profession has always urged its members to exercise care in the prescribing of such products. The AMA has taken a leadership role in providing important scientific information to the practicing

physician regarding the use of all drugs in the practice of medicine. The AMA regularly prepares a volume, AMA Drug Evaluations (AMA-DE). We have a copy of this publication for you, Mr. Chairman, and for the committee.

Mr. WOLFF. Thank you.

Dr. BOYLE. This is produced in cooperation with the American Society of Clinical Pharmacology and Therapeutics. This publication is now in its third edition to keep abreast with the constantly changing and expanding knowledge concerning the great variety of drugs available in medical practice. AMA-DE is designed to provide practicing physicians with an up-to-date unbiased scientific evaluation of available drugs. In the section of AMA-DE concerning psychotropic drugs physicians are warned that:

Because of the proliferation of psychotropic substances, the physician, today more than ever before, should guard against contributing to drug abuse through injudicious prescription practices or by acquiescence to the demands of some patients for instant chemical answers to their problems * * * In essence, he can play a preventive role in his practice by exercising good judgment in administering and prescribing psychotropic drugs, so that diversion to illicit use is avoided and the development of drug dependence is minimized or prevented.

This statement reflects AMA policy regarding the use of all psycho tropic substances.

AMA also publishes a wide range of current scientific information in its weekly Journal of the American Medical Association (JAMA) and in the Archives of General Psychiatry. In an upcoming issue of JAMA a statement of the AMA Council on Scientific Affairs will be published on the clinical aspects of amphetamine abuse. Earlier issues of JAMA contained articles by the AMA Committee on Alcoholism and Drug Dependence on the use of barbiturates in medical practice. Also, our house of delegates has repeatedly spoken to the issues of drug abuse and drug dependence. At its two most recent meetings December 1977 and June 1978—the house expressed its concern regarding the use of amphetamines and barbiturates in medical practice and urged caution in their use. Mr. Chairman, the general subject of

the use and abuse of psychotropic drugs is indeed a complex one. First, the term "psychotropic drugs” refers to a wide variety of drugs used for various medical purposes, including uses apart from their psychotropic effects. Second, there is no reliable data that indicate exactly the way these drugs are actually used in medical practice. While there are national prescription surveys that indicate how many prescriptions for a particular drug are written for patients at a specific dose, these surveys are not informative as to the many factors that go into determining why a particular treatment regimen was ordered. Moreover, available data on actual drug use are fragmentary at best. The Joint Commission on Prescription Drug Use created at the request of Senator Edward M. Kennedy and composed of various professional organizations (including AMA) and other groups, is now attempting to determine whether a drug use surveillance and data acquisition system is even feasible in the United States and, if such a program appears to be feasible, what form such a system should take. Dr. Freedman is AMA's representative on this Commission.

We do not believe that statistics regarding the total annual number of prescriptions written for a particular drug can really answer questions pertinent to a determination as to whether there is overprescribing or misprescribing of that drug. For example, the medical need for a specific antianxiety agent may be underestimated particularly in the absence of data establishing the number of individuals actually suffering from anxiety symptoms severe enough to warrant a physician's attention. Higher than expected use of these drugs could also be attributed to increased access to health care now available under Federal programs such as medicare and medicaid or to the trend in treating mental illness in the community rather than in institutions. A greater willingness among some groups to seek help can lead to increased uses of these drugs in certain populations. In any event, it must be remembered that conditions such as anxiety are often attributable to factors beyond the control of medicine, such as inflation, unemployment, family relationships and shifting social values and job-related problems.

Mr. Chairman, all psychotropic drugs are currently regulated under the Food, Drug, and Cosmetic Act and most are covered by the Con

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