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Dr. SCHIFRIN. Complete and objective.

Mr. NELLIS. And I want to ask you first: Do you have any figures on what the drug companies spend for research as compared to the promotion of their products!

Dr. SCHIFRIN. Yes. There are two sets of data on research, one provided by the Pharmaceutical Manufacturers Association, and the other by the National Science Foundation which uses more stringent definitions. I would put research at 8 percent of the sales dollar as an allindustry average.

Mr. NELLIS. As compared to 22!

Dr. SCHIFRIN. I use 22 as a more conservative figure. Other economists use a 25-percent figure. Roughly 6 to 8 percent for research would be a good rule of thumb.

Mr. NELLIS. As you know, the ethical drug companies frequently state publicly that but for the prices they charge, but the profits they make, research would suffer. And on a ratio of 3 to 1, your thesis might be correct, namely, that the information aspect, the promotion aspect, could be reduced somewhat, and that reduction could take place without harm to research. Is that a correct assumption?

Dr. SCHIFRIN. There is a lot of cost decrease that could occur without taking anything away from the research dollar, yes, sir. But there is another point. There is a logical inconsistency in that point, that high profits are necessary to finance research. Research is a cost of doing business. Profits are left over after all costs have been covered, including doing research. Profits are residual. They don't support research but are what is left over after doing research.

Mr. NELLIS. Yes, but that is a double-edged sword here. We have one of the most profitable industries in the world; is that correct?

Dr. SCHIFRIN. Yes, sir.

Mr. NELLIS. Certainly the pharmaceutical industry is extremely profitable and the profits keep mounting even though the prices may not.

Dr. SCHIFRIN. The rate of profit is high and essentially stable, yes.

Mr. NELLIS. Professor, let me ask you this question. Because of the high rate of profit and because of the profitability of drugs which, after all, perform a human health function, and because of the practices of the physicians, we are rapidly becoming a chemically dependent society. Is that a correct assumption?

Dr. SCHIFRIN. I am an economist, not a pharmacologist. I would say there are very compelling, perhaps an overwhelming preponderance of opinions that I have read to that effect, yes.

Mr. NELLIS. All right, now, let me ask you about these advertisements. You have looked at that chart up there, have you, Dr. Schifrin?

Dr. SCHIFRIN. Yes, sir. Mr. NELLIS. Would you say that any of them are misleading to the physicians ?

Dr. SCHIFRIN. Well, we have to take into account who we are talking to. At first when the FDA tried to get some regulation of advertising, the defense was that the physician is so well informed that he can't be fooled, so no matter what you say to him he's going to glean the truth out of it or if there isn't any truth he is going to throw away all that other information.

I don't think that is very true. I think there are overt and covert and subliminal and obvious messages in all of these.

For example, just looking at all these ads, you say, “Are these going to fool the physician?” Well, I like to think I am as competent as the average physician, and I would look at that and say, "Well, it sure appears to me that these scientists who are behind these ads are telling me it's essentially a woman's problem.” We see the empty nest syndrome, women here, married, old, young, and all over the place. It gives me sort of a knee-jerk response to identify—somebody gives some symptoms and they say, "Oh, you are just another neurotic middle-aged woman. Take your Valium and everything will be OK.”

Mr. Nellis. Your knee-jerk response was just the one I was looking for, because the advertising was directed at the physician to remind him he has stressful, anxious, geriatric patients, mostly women, and stressful, anxious, housewives he needs to tranquilize. And these ads, as I read them as a layman, seem to stress that particular aspect.

Would you agree, Dr. Colé?
Dr. COLE. Yes.

Mr. NELLIS. Why is it that the drug companies are telling tho physicians to tranquilize the women of this country?

Dr. COLE. Perhaps because women see doctors somewhat more frequently than men.

Mr. NELLIS. That is one explanation, yes. Would there be others ?

Dr. COLE. Male chauvinism perhaps on the part of the advertisers, but I don't know of any other reason. I don't know any evidence that women respond better to the drugs than men, though I don't know anybody who has looked at this very carefully with respect to these drugs.

Mr. NELLIS. But you as the physician are being used as the conduit by which this result is accomplished. And if you are the careful physician that you testified earlier you were, you would not pay too much attention to the fact that these ads are directed to you in terms of getting to your women patients, would you?

Dr. COLE. No; I don't, but I suspect other people do.
Mr. NELLIS. I think my time is
Mr. WOLFF. Mr. Gilman.
Mr. GILMAN. Thank you, Mr. Chairman.

Gentlemen, do you feel our physicians are receiving adequate enough training in pharmacology in order to be able to make a wise determination, a proper determination, in the drugs that they are working with, in prescribing the drugs and keeping up to date on the utilization of the drugs and the side effects of the drugs?

Dr. Cole.

Dr. COLE. I don't know. There's certainly a lot more continuing medical education in terms of lectures, seminars, and so on, now than there was even 5 years ago, so there is more access to this.

Mr. GILMAN. Is it adequate enough! Dr. Schifrin says that the physicians have become dependent upon the drug firm representatives and the advertising materials to keep up with the new and continuing education on drugs. Do

you feel that this is the situation? Dr. COLE. I don't know enough about how many courses are given, who attend, and that sort of thing. So I think there is more available.

Mr. GILMAN. You are a consultant, are you not, for drug firms!
Dr. COLE. Yes; I am.
Mr. GILMAN. Who have you worked for?



Dr. COLE. Sandoz, SKF, and I have consulted once for Mead John

Mr. GILMAN. Is that in relation to the preparation of new drugs for marketing?

Dr. COLE. It is generally in relationship to the development of drugs. I work mainly at the investigational drug level before they go on the market, although a couple of times I've gotten involved in marketing issues-mainly not.

Mr. GILMAN. Apparently, then, you have been intensely involved in the preparation and marketing of drugs. Do you feel that the physician today is properly prepared or properly trained and has the proper information for the dissemination of the various drugs that he is using?

Dr. COLE. I don't know.
Mr. GILMAN. Dr. Schifrin, would you care to comment on that?

Dr. SCHIFRIN. Yes; I would like to say this, to give you a point- nk answer. I don't think the typical physician is adequately trained. However, I am not sure the typical physician can be adequately trained. I think to expect the physician to embody all of this knowledge is an unrealistic expectation, and I think the trends in the health care sector are to place greater reliance and raise the roles of other people who have been subservient, so to speak, to the physician. I am thinking, for example, of what we call the clinical pharmacist. Pharmacy is really a profession—this is a bad generalization of perhaps overeducated people. The tasks they have been permitted to do are very mundane when compared to the technical training they have obtained. But more and more the pharmacist has a broader role, to actually provide the technical input on drug information to the physician in his choice of drugs.

Mr. GILMAN. But how much consultation is there between pharmacist and physician when it comes to prescribing the proper medication?

Dr. SCHIFRIN. It is limited, and it is mainly in an institutional setting where the physician is there and the pharmacist can be made part of that team.

Mr. GILMAN. Does the physician consult with the pharmacist in making a determination of the medication? That is not what I have seen in a hospital.

Dr. SCHIFRIN. Of course, we are talking about a broad range of institutions, and my own active time spent with medical faculty was at Stanford University, which I think does things that have not yet come to other institutions. The clinical faculty had made a transition. At first they were protective of the superior position of the physician. Then it came to the time when a physician would make a decision and look to the clinical pharmacist for ratification, and then the physician, before making his decision, would ask for the technical input from the clinical pharmacist. So perhaps on a limited basis this is a very healthy change that is beginning but it has a rather firm foothold in its growth.

Mr. GILMAN. What I am trying to explore with you is: If there is a need out there for better training and more adequate preparation to make a determination of which medication to use and I assume this is an important tool for the medical profession, to utilize the proper medication, the proper drugs—then shouldn't we be doing something about encouraging that training and that preparation ?

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Dr. SCHIFRIN. One, the physician's liability is pushing them toward it. Two, this trend toward recertification and relicensure of medical personnel Dr. Cole mentioned is going to make continuing medical information of all sorts, particularly in pharmacology, a requirement.

Mr. GILMAN. Are medical schools giving sufficient attention to pharmacy as a way of training?

Dr. SCHIFRIN. I am involved actively now with the University of Virginia School of Medicine, but my contact has been limited to four medical schools. However, I called the publisher and editor of this textbook, and she said it is going very, very well, with a second printing coming up, mostly in the paperback edition because that is what medical students buy. And I have to take that as an indication that the second edition of the book is more popular than the first. That is based on a sample of one.

Mr. GILMAN. Are medical schools today taking the proper ap; proach to providing adequate training? Is there something we could do legislatively to make certain they are doing that?

Dr. SCHIFRIN. Well, I would say this: You are asking me for a great generalization. First, medical schools are extremely diverse. Second, there is so much competing information in that short period of time in which physicians have their formal education it is difficult for me to say that more of something would be better in the long run than more of something else.

I tend to like pharmacology and am interested in it, but I can't say more of it would be better. Nonetheless, I say that more and more pharmacology training is coming into effect. I see it in the medical schools that I have had contact with. But there still are medical schools that are very conservative and who do things in traditional ways and don't believe the curriculum needs to be changed for their particular school.

Mr. GILMAN. Dr. Cole, did you want to comment ?
Dr. COLE. Yes; on two issues.

First, most of the pharmacology training in medical school has been in the second year. They get taught pharmacology before they see patients. If I were to do anything I'd try to get more clinical pharmacology training into the clinical years, the third and fourth years. And if I were giving away money—which nobody wants to do these days—I'd maybe give a grant to schools to hire at least one clinical pharmacologist and try to impact on the advanced training of both medical students and house staff.

With regard to nursing homes, the prescribing of drugs there gets bad for a variety of reasons. One is I think that a nursing home will have like 150 patients who may be being cared for by 75 physicians who buzz by once a month and write some orders. And I think there is a lovely place for a clinical pharmacist to review all the medications of all patients, make suggestions to the doctors, and be sort of the middleman between the nursing staff and the physicians doing the prescribing and call up the doctor and say something.

So if there were fünding under medicare or medicaid, if a salary for a clinical pharmacist attached to each nursing home were mandated by the regs, I think this would improve the level of prescribing in nursing homes substantially.

Mr. GILMAN. I presume both of you agree, then, that we shouldn't allow the current updating of professional education to rest upon the shoulders of the advance men or detailmen for the drug firms but should be done in a more formal professional manner. Are you agreed that is something that is needed?

Dr. COLE. Yes.
Dr. SCHIFRIN. Totally.
Mr. GILMAN. Thank you, Mr. Chairman.

Mr. WOLFF. We will recess now until this afternoon's session at which we will have an additional panel at 2 o'clock.

We thank both of you gentlemen for appearing here with us today. You have certainly added to our body of knowledge.

Dr. SCHIFRIN. Thank you.
Dr. COLE. Thank you.

[Whereupon, at 1:25 p.m., a luncheon recess was taken, to reconvene at 2 p.m.]


Mr. GILMAN. The committee will come to order.

This afternoon's hearing on advertising, detailing, and medical prescribing in the psychotropic drug industry is a continuation of this morning's hearing on this subject.

This morning we heard from Charles Brannan, a former drug salesman with Hoffmann-La Roche, who indicated the pressure that was exerted on the detailmen by that company's divisional and regional sales managers to get the physician to prescribe HoffmannLa Roche products, particularly Valium, and I quote, “by any means *** to get the business any way they could."

We also heard from Dr. Leonard Schifrin, professor of economics at the College of William and Mary, who indicated some of the ways that the drug industry influences the usage of drugs, particularly psychotropics, and who also observed that the medical community is partly to blame for allowing the physician to become highly dependent upon detailmen and advertisements for their drug information; and Dr. Jonathan Cole, chief of the psychopharmacology program, McLean Hospital, Belmont, Mass., who stated: “Drugs like Valium are really much safer than most other drugs. Huge doses, taken alone, are not lethal.” He also asserted that drug company advertisements do not have a great impact on doctors.

This afternoon the Narcotics Select Committee will hear from Irwin Lerner, vice president of marketing, Hoffmann-La Roche Inc.; Ms. Sue Boe, assistant vice president, consumer affairs, of the Pharmaceutical Manufacturers Association; and Dr. Robert Maronde, professor of medicine, section of chemical pharmacology, of the University of Southern California.

Gentlemen and Ms. Boe, we welcome you before our committee and look forward to your testimony.

Before I proceed, I will swear in our first witness, Mr. Lerner.
[Whereupon, Mr. Irwin Lerner was sworn.]
Mr. GILMAN. You may proceed.

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