no way of checking the figures and what if any individual working for a wholesaler does not record the information.

On June 30, 1976 I was rated Group 4 which exceeded standards by my divi sional manager Phil Shapiro and on Sept. 10, 1976 I received a letter from Mr. Shapiro stating that I was in Group 3 or met standards with an annual salary increase of $680 which was the lowest salary increase I had ever received since I had started working for Roche in 1969. I wrote to him but did not receive an answer. In June I had separated from my wife and two boys because I was not able to cope any longer with the Roche pressure and and was irritable and hostile. I was totally depressed and could no longer push Roche's products. On Sept. 22, 1976 I went out on a medical disability. I never thought this would happen to me like it did to Bill and John. Even while I was on a medical disability trying to regroup and again be able to handle pressure, I would receive phone calls from Mr. Shapiro wanting to know when I was going back to work. I also received the attached mailgram on Feb. 2, 1977 when I wasn't even making doctor calls for five months. Finally, Mr. Shapiro went to see my doctor and ordered him to have me back in the field in one month. This reminded me of when John Henderson would receive shock therapy on an outpatient basis at Encinitas Hospital at 8 o'clock in the morning and Mr. Shapiro would pick him up at the hospital and at 10 o'clock John Henderson and Mr. Shapiro would be working a display for Roche pushing Valium, Librium and Dalmane. I had worked with John because I was promoted into his MCR territory. I would have to take him home because he would be experiencing lithium toxicity which included nausea and dizziness. Lithium is a drug used to treat manic depressive states and has to be titrated closely.

I sincerely hope that I have given you a better understanding of what a detailman does, how he is evaluated and what pressures can be imposed on him to sell his drugs at all costs. How would you feel if you had been a salesman for 10 years selling your products ethically and honestly and a new division manager arrives and puts you on probation for the next six months and you have to prove yourself in his eyes to keep your job? How do you stop a regional manager from retiring salesman after twenty years of hard work because he would not make deals in pharmacies with samples to keep his job and lie to make his sales quotas? What is happening to the ethical pharmceutical salesman whose job was to honestly inform the doctors of the merits of his companies products? He is becoming extinct because the job, the market and the decision makers have changed. How many more dedicated professional pharmaceutical salesmen will be destroyed by the master manipulators whose only motive is profits at the expense of many unsuspecting patients who think they can find happiness in a pure white, yellow and pale blue pill called valium?

ATTACHMENT I

[Western Union Mailgram]

DECEMBER 13, 1976.

PHILIP A. SHAPIRO, 3544 Villanova Ave., San Diego, Calif.

I have just received an analysis from an independent audit firm that reports physician calls on an anonymous basis. In the sample of 46 physician calls, Valium was presented 18 times-considerably less than half. Total time of Valium presentations was 18 minutes-slightly over 2 minutes per presentation. What a shame for a product of such versatility, medical application, and importance to us. This report on Valium presentations could reflect a serious deviation from our stategy of Valium first on all calls except pediatricians.

The southern area has a good share of the market, but Valium new prescriptions are flat and new competition is imminent. Let's get on with the strategy of Valium number one on all calls now to keep what we've got and to assure the necessary growth in 1977.

Please send a written note to your regional manager by December 17, indicating your understanding of this directive and your commitment to Valium on every call. Your division manager will be monitoring and following up on the implementation of the strategy.

JOHN E. BOYLE, Field sales manager.

ROCHE LABORATORIES STATEMENT OF POLICY ON DISTRIBUTION OF PATIENT STARTERS OF PRESCRIPTION DRUGS

It is the policy of Roche Laboratories to distribute selected pharmaceutical products to physicians, through our field representatives, in accordance with the following principles:

1. Such products, either specially packaged or in stock packages, are for free distribution only to physicians who request such supplies. Under no circumstances are they to be used in any other manner and are never to be sold or exchanged for anything of value.

2. The distribution of these materials will be in accordance with appropriate instructions from Roche Laboratories. The specific procedures to be followed are contained in the Policies and Procedures Manual.

3. Quantities supplied, upon request of the physician, shall be in reasonable amounts and related to the need of the recipient.

4. Possession of prescription products is a serious responsibility. Every precaution must be taken to avoid possible pilferage or access by unauthorized persons.

I understand and agree that any violation of these principles is cause for my dismissal from employment by Roche Laboratories.

Employee
Date

(Supervisor)

[ATTACHMENT III: Drug Distribution Data System-in committee files]

PREPARED STATEMENT OF LEONARD G. SCHIFRIN, PROFESSOR OF ECONOMICS, COLLEGE OF WILLIAM AND MARY, WILLIAMSBURG, VA.

I thank you, Mr. Chairman, for affording me the opportunity to testify before you today. I have been a student of the drug industry for many years, and I would like to offer you some of my views of the industry and the ways in which it influences the usage of all drugs, particularly psychotropics, in our society.

A truism about all drugs is that if they are strong enough to do good, they are strong enough to do harm. Each drug, with an equal potential for help and harm, is indeed a metaphor for the industry as a whole. The drug industry, especially the prescription-drug sector, has been of great service to mankind in improving the human condition, and no doubt will continue and even increase its contributions in the future; yet at the same time several of its practices and even its success itself have given rise to compelling problems in regard to the role and use of drugs in our society. These problems are of many sorts, but largely fall under the headings of misuse, over-use, and other abuse, of legal drugs, both prescription and non-prescription, and of illegal drugs.

Paradoxically, the drug industry's great success in the antibiotics field has led us to believe that drugs offer effective cures across the whole range of human problems. The industry, quick to nurture this belief and to capitalize on its development, spends upwards of two billion dollars a year to influence physicians (in the case of prescription drugs) and consumers (in the case of nonprescription drugs) toward the use of drugs to alleviate all sorts of symptoms of distress and to gain the selection of their labels in the marketplace. Price competition rarely occurs; competition in differentiation, novelty, claims, and promotion is the cutting edge of market rivalry. It is a demandexpanding strategy, requiring self-discipline to protect the physician and the public, yet commonly lacking it. As a result, it must be monitored and regulated lest the messages conveyed not conform to sound medical judgment. Among the areas where this sort of uncritical and unconstrained promotion and acceptance of drugs is most prevalent is that of psychotropic drugs. Well over 25 percent of all prescription drug sales, by dollar volume, is for drugs primarily affecting the central nervous system; further, there is considerable medical criticism that irrational prescribing is more commonly found for tranquilizers and other psychoactive agents than any other class of drugs.

And in the non-prescription area, much the same criticism is made for overthe-counter sedatives, sleeping aids, and stimulants.

The problem of drug overutilization, particularly of psychotropics, is not peculiarly American. The American experience parallels and reflects that of other developed countries. In this regard, Dr. Karl Evang, the Director-General of the Health Services of No way, made this perceptive and eloquent comment in 1969:

Finally, the increased interest which governmental health agencies and other regulatory organs show in relation to drugs is caused by the highly worrying fact that some of these drugs also have dependence-producing properties. In technically and economically advanced countries with well developed health services and a high purchasing power in the population, the number of persons dependent upon one or more of the new drugs is often already considerably higher than that of the classical addicts (morphine, opium, heroin, cocaine). It has in some countries been estimated that this group of narcomaniacs already represents three to ten times as many as those addicts which we knew beforehand. I am of course especially thinking of drugs among the analgesics, centrally stimulating drugs, ataraxics (tranquilizers), and hypnotics. Individuals addicted to one or more of these drugs will generally be adults with the exception of the centrally stimulating drugs (amphetamine group), which is also extensively used in some countries by youngsters together with LSD and other hallucinogens. In youngsters— even in children-one has also, especially during the last 5-10 years, a growing trend towards experimentation with drugs sometimes with tragic results.

people do not yet generally have a rational approach to drugs but a magic one. Also the type of information and promotion which have so far taken place seem to have given many people the feeling that they can lead a healthy life through chemical manipulations of their body and mind. In fact it seems to be a widespread feeling that chemical manipulation is a condition for health. One can understand and appreciate why this attitude has grown: the starting point in the present era of pharmaceutical products was based on antibacterial drugs and substitution therapy. The "wonder drugs" were found primarily in these fields and had dramatic effects. During this same period prophylactic medicine grew in breadth and depth, with the result that several nature-given pathogenic agents were gradually brought under control. Many of the great killers amongst diseases lost their sting: malaria, cholera, tuberculosis, smallpox, plague, yaws, typhoid, pneumonia, etc.

Partly or wholly "man-made" pathogenic factors took over as leading causes of death (heart and circulatory disease, accidents) or as strong contributors towards the panorama of disease (neuroses, obesity, weak discs). The success which the new drugs had obtained in relation to the nature-given pathogenic agents inspired the field of sociological pathogenic agents. As one would expect, the impact here is necessarily limited. More than that, to transfer experience which a patient has had using an antibacterial drug to a painkiller, tranquilizer, or stimulant may not be in the best interests of the patient. It prevents him and sometimes also his doctor from going into the real and sometimes complicated causation. The patient's strong trust and belief in drugs reduces his interest in a more health living pattern, exercise, optimal nutrition, moderate use of alcohol, tobacco, etc. Anxiety states, tension, aggression, inhibitions, maladjustment, alienation-with their manifold and deep effects on the individual as a whole-are as a general rule caused by sociological factors, and any causal therapy should therefore include attempts to change these sociological elements, but drugs cannot change the environment of the patient or the client : family, school, university, place of work.

Sometimes, therefore, in a pessimistic mood the health administrator may ask himself whether the most widespread adverse reaction to drugs in our days is not the attitude that there is a drug for every disease.

I have been critical here and elsewhere of the quantity and quality of prescription and non-prescription drug advertising in creating the problems that Dr. Evang laments. However, the drug industry does not bear sole responsibility for these problems. In part, the medical community is to blame for allowing the prescribing physician to become highly dependent on drug firm representa

tives and advertising materials for his new and continuing education on drugs. In part, the regulatory area of government has failed to develop and foster new, objective, and effective informational mechanisms. And among the more culpable contributors is the popular press. I cite here not only the Readers Digest's monthly enthusiasm for the latest wonder drug, but the Wall Street Journal's quickness to relate usually prematurely and often wrongly-the latest great therapeutic discovery; and now, too, the staid Saturday Review has taken a front seat on that bandwagon.

In general, the American public, quite wrongly, has come to see drugs as symbolic of "health care." We are a people seeking cures rather than prevention. When a friend or relative feels the need to see a physician, we later ask them not "What was the problem?" but "What did the doctor give you for it?" We want tangible drugs as proof that our problems are real, that doctors care, and that something is being done for us. Perhaps the wag who said "What the world needs is a more effective placebo" knew us better than we know ourselves.

In conclusion, I would like to offer this comment: it is not necessarily true that less use of drugs would improve our well-being. What is needed is a wiser, a better-directed use of drugs. In some areas of health care, drug therapy probably is under-utilized, and warrants greater application based on cost-effectiveness comparisons. But in other areas, drugs are seriously over-utilized, to the economic and physical detriment of patients. Both problems exist side-by-side, and improved health care depends in large part on developing drug utilization patterns with higher degrees of appropriateness than now are found. We must be aware that the human body does not need and cannot succeed in achieving a fine tuning by the ingestion of chemicals; that variations in physical functioning and mental attitudes are "medical problems" only if we let them be defined that way, and once so defined, we will receive only medical solutions for them; that many of the problems of life are simply that: the bumping of our psychic shins in the passages of life. They are not "medical" problems, but "people" and "living" problems; our solutions to them should increasingly come from personal contact, support, and reinforcement rather than chemical mood-alteration. Well-being results from the enhancement and protection of human personality and capability, and sometimes requires medical intervention. But it is not a commodity we buy, or obtain from magic bullets out of a bottle. I laud your efforts, Mr. Chairman and members of this Committee, in moving us toward the recognition of these important truths.

TABLE 1.-VALUE OF MANUFACTURERS' SHIPMENTS, PHARMACEUTICAL PREPARATIONS, EXCEPT BIOLOGICALS, 1974-76, AND ESTIMATED 1977-78

TABLE 2.-PROMOTIONAL EXPENDITURES FOR DOMESTIC CNS ETHICAL PREPARATIONS, 1977 AND 1978 (ESTIMATE)

PREPARED STATEMENT OF JONATHAN O. COLE, M.D., CHIEF, PSYCHOPHARMACOLOGY PROGRAM, MCLEAN HOSPITAL, BELMONT, Mass.

THE MEDICAL USE OF ANTIANXIETY DRUGS

I am Dr. Jonathan O. Cole, Head of Psychopharmacology at McLean Hospital in Belmont, Massachusetts and a Lecturer at Harvard Medical School. I have been active in research and teaching in clinical psychopharmacology since 1956 and for eleven years ran the National Institute of Mental Health's Psychopharmacology Research Branch. I have served as Superintendent of Boston State Hospital and Chairman of the Psychiatry Department at Temple Medical School. I have worked at McLean, a 250-bed private psychiatric hospital doing psychopharmacological consultation, treatment, research and teaching for the last five years. I have served in NIMH and NIDA review committees, American Psychiatric Association task forces and as President of the American College of Neuropsychopharmacology. I have written over 200 papers and have edited several books in psychopharmacology and have taught on at least 100 continuing education programs for physicians in psychopharmacology. I occasionally serve as a consultant to drug companies on the development of psychoactive drugs and have carried out studies of both marketed and investigational drugs for drug companies or under federal grants.

However, although I know a good deal about psychiatric drugs, their benefits and risks, I am not an expert on how doctors use psychiatric drugs in every day practice. Unfortunately, I don't believe that there are any experts in that important area. The questions which appear to concern this Committee particularly seem mainly to be unanswerable without conducting special studies of physician attitudes, medical practice or patterns of patient care.

Most current data comes from prescription surveys of various sorts which tell us very, very little other than how much of which drugs are prescribed and by what general groups of doctors. This information is inadequate for making legislation, regulations or policy decisions.

The present hearings are focussed on alleged Valium overuse. Even though we know how much Valium is prescribed in a given year and know that the United States uses this and related drugs at about the same rate as England, France or Sweden, we don't and can't know whether Valium is being overprescribed or underprescribed because no one has developed usable criteria for rational Valium use. Karl Rickels has studied the use of antianxiety drugs in general practice and finds, not surprisingly, that patients prescribed antianxiety drugs rate themselves as more anxious than ordinary "medical" patients. Reasonable criteria for prescribing drugs like Valium are probably the presence of moderate to severe anxiety which is distressing enough to interfere with a patient's work and/or social functioning. Since we have no laboratory test to measure anxiety, we are dependent on the patient's complaints and, sometimes, behavior to judge the degree of anxiety. I suspect that almost all patients given drugs like Valium either meet my crude criteria or have physical or medical symptoms which appear to be produced or aggravated by stress or conscious or unconscious anxiety. I seriously doubt that doctors foist drugs like Valium onto reluctant patients. I think it's more likely that patients sometimes come to a doctor feeling strongly that they need a tranquilizer and, in fact, get prescribed one.