Senator McCLELLAN. Our committee will be in recess for 5 minutes. We will resume in 5 minutes. (Brief recess.) Senator MCCLELLAN. Dr. Seevers? STATEMENT OF MAURICE H. SEEVERS, PROFESSOR AND CHAIRMAN OF THE DEPARTMENT OF PHARMACOLOGY OF THE UNIVERSITY OF MICHIGAN MEDICAL SCHOOL Dr. SEEVERS. Yes, sir. Senator MCCLELLAN. All right, Doctor. Please identify yourself for the record. I believe you have a prepared statement. You may proceed in your own way. Dr. SEEVERS. I am Maurice H. Seevers, a professor and chairman of the Department of Pharmacology of the University of Michigan Medical School. Senator MCCLELLAN. First I would like to say I am sorry we did not get to you when you were scheduled yesterday, or the day before yesterday, I believe. Dr. SEEVERS. It worked out all right. Senator MCCLELLAN. We have tried to move along here with all deliberate speed. Dr. SEEVERS. It worked out all right with me, so thank you very much. I am a physician and have been engaged in teaching research and administration in academic pharmacology since 1930, at the Universities of Wisconsin and Michigan. I am professor and chairman of the Department of Pharmacology of the University of Michigan Medical School in Ann Arbor, Mich. I received a Ph. D in pharmacology from the University of Chicago in 1928 and an M.D. from Rush Medical College of the University of Chicago in 1932. I am licensed to practice medicine in Wisconsin and Michigan. During the last 35 years I have worked with, or served as a consultant to, many organizations which deal with the effects of drugs and chemicals upon health and welfare, both here and abroad. I have been fortunate in having had the opportunity to walk in the halls of learning, professional societies, Government, and industry, and am able to distinguish but one high level of public morality among the leaders in these several facets of American society as it relates to the public health and welfare. I am a past president of the American Society for Pharmacology and Experimental Therapeutics. I served as chairman of the Section of Experimental Therapeutics and for 10 years as a member of the Council on Drugs of the American Medical Association. Currently I am chairman of the committee for research on tobacco and health and a member of the committee on alcohol and addiction of the same organization, and have acted in an advisory capacity to many Government agencies. I have served the Government as a consultant to the Food and Drug Administration, the Department of Defense, the Veterans' Administration, the U.S. Public Health Service, and the Office of Science and Technology. I was a member of the Surgeon General's Advisory Committee on Smoking and Health, and am currently Chairman of the Committee on Behavioral Pharmacology of the National Institutes of Mental Health. I have served as a consultant to the pharmaceutical and chemical industry for remuneration. My principal area of competence is in the field of narcotics and drug abuse, and I served as a member of the Ad Hoc Panel for the White House Conference on this subject in 1961. I have read the statements of the American Council on Education and of Austin Smith, M.D., president of the Pharmaceutical Manufacturers Association, concerning S. 1809. I believe the essential facts are presented fairly and rather completely in these two documents, and I will not reiterate most of their points. I wish to comment especially on the detrimental effects on the quality and quantity of research in the drug field, not only that conducted in universities, but also in Government laboratories, and its effect on training of new scientists if a Government-take-all policy is applied to Government-sponsored research in the health-related sciences. In the field of drug development the role of the pharmacologist differs significantly from that of the chemist, and his findings are much less subject to exclusive control. The chemist, for example, invents a new compound or develops a new process for manufacturing an old chemical, and can obtain exclusivity for the duration of the patent under the present circumstances. A pharmacologist, on the other hand, studies the effects of new or old chemicals in animals or man in the hope of finding a cure for disease or a substance which will speed recovery or make the patient more comfortable. Usually these observations cannot be controlled exclusively. They come under the public weal. To cite an example: In our laboratory we are studying the effects of morphine-like narcotics on the monkey in the hope that a new painrelieving drug will be found which will be nonaddicting. During the last 15 years we have screened over 600 new drugs from all of the major domestic and foreign pharmaceutical companies. This, in fact, represents the world supply. This program is supported by contributions from over 40 pharmaceutical manufacturers through the Committee on Drug Addiction and Narcotics of the National Academy of Sciences and National Research Council. Any chemist, domestic or foreign, may submit new compounds through the secretary of this committee for study. He sends them to our laboratory for testing as unknowns under code number, and the information is channeled back to the supplier. Under this program we are able to maintain an on-going university laboratory for research and training in this field of behavioral pharmacology. Industry retains exclusively of drug control. Under present Government policies, conducting such a program with National Institutes of Health support would not be possible since industry would not make the compounds available to our laboratory. Maintenance of a laboratory of this type by an individual company would be pro hibitively expensive, and this joint effort of the industry reduces the total cost of production of what may ultimately be a clinically useful compound. I might depart from my statement to say that several clinically useful compounds have come out of this program and are currently in clinical use. Senator MCCLELLAN. Do I understand you to mean by your sentence just above there, "industry retains exclusivity of drug control," that they get the patent, they own it? Dr. SEEVERS. Yes, they own the patent. Senator MCCLELLAN. In other words, if they send you a drug for experimentation and you develop it, they retain the patent? Dr. SEEVERS. That is right. Senator MCCLELLAN. And you say that if the Government makes a contribution and takes that, then they are not going to send it there for Dr. SEEVERS. They won't send the drugs. This is one of our biggest problems today in pharmacology and clinical pharmacology, because the industry will not send drugs into many university laboratories, because of the fact that we are supported by Government in some of our activities. Furthermore, if we find, for example, that a drug under a certain name is metabolized in the body to create a new substance, which turns out to be the active substance, this new substance then completely wipes out everything that happened with the old one. It now becomes the useful substance. And if it is discovered in a Government-supported laboratory project, the Government holds the patent. So industry automatically has lost its hold over that compound, simply because a new substance which is developed by the metabolism of the body now becomes a useful substance. Because of this, many industries will not send drugs into the clinical pharmacologists for drug development. Senator MCCLELLAN. Now, is the public health served or is it not served in the circumstance that you are illustrating and testifying about? Are the public health and welfare served by permitting the patent on any discovery to remain in the ownership of the one that transmits the drugs to you? Dr. SEEVERS. We feel it is, because it is not possible, for example, for the university to develop a drug clear through to the point of marketing. We have no facilities for doing this. The Government does not have the facilities for doing it, either. In fact, there is only one group that can operate independently of the Government or the university, and that is the industry. They have their own chemists, their own pharmacologists. They have their own drug control laboratories. If necessary, they could develop-which I think would be exceedingly unwise-their own clinical facilities in a group of smaller hospitals which are not university associated. Senator MCCLELLAN. This would have its impact on the university, would it not? Dr. SEEVERS. Not only on the university, but an impact ultimately on the public health, for the simple reason that most of the smaller hospitals, even though the doctors are qualified, are not qualified in the problem of drug development. They do not have the facilities to carry on the laboratory work that is necessary in relationship to it. Furthermore, it would in the long run interfere seriously with this problem of the ultimate public health, as far as new drugs are concerned. I might say just for your own information that 90 percent of all the drug information that we teach medical students today did not exist 40 years ago, and 70 percent of it did not exist 20 years ago. This was brought about largely by the fact that we had a strong cooperative program of Government, industry, and universities, during the war. The large antimalarial program, and the large program associated with the development of chemical warfare promoted such a large chemical development that many of these compounds naturally were found to be biologically useful. This effort, of course, involved everybody's dropping what they were doing to work on these major programs to aid the war effort. This, then, was probably the best example of a large cooperative effort even though it was not voluntary. I think there are still some people that believe that all drug development should be carried on on this basis. This could be done in wartime; but today, to get this kind of cooperation requires that it be done voluntarily. It means very simply that the interests of everybody have to be engaged, there has to be mutual respect and confidence between industry, Government, and the universities. I do not think it is possible to administer or legislate or regulate or coerce this type of research. It never has been in the past, and I think real cooperation is always on a voluntary basis. I might depart further from my statement simply to say that the pharmacologist is not particularly interested in exclusivity of control. We are interested basically, as individual scientists, in getting new compounds to study biological processes. Most of these are not subject to patent, anyway, except as use patents and they are not as useful as invention patents. One other point I would like to make, which I think has not been brought before you, is that a patent in the drug field today is not worth too much, anyway, except for a short-lived term of exclusivity. The movement today in the drug field of the development of new chemical compounds is so fast that about the time a drug reaches the market, a better one is on the drawing boards, and in a year or two it will supplant one that is currently marketed. Senator MCCLELLAN. Let me ask you a question at this point. What profit is there to the Government and the public, the people as a whole, for the Government to take that patent or that new discovery and put it on the shelf? Dr. SEEVERS. I didn't quite understand you. What does the Government gain? Senator MCCLELLAN. Yes. What would the Government profit out of it, what would the public profit out of it, if as you say, by the time you got that drug well developed and on the market, a new one will be coming along that would probably be a better one and take its place, then, not within the 17 years in the patent statute, but maybe 2 or 3 years after it first hit the market? Dr. SEEVERS. I think the 17-year matter is completely unimportant in this field. Senator MCCLELLAN. It has no applicability? Dr. SEEVERS. The Government would not profit very much, to answer your question directly. Senator MCCLELLAN. Well, the point is, if the Government takes it, and then somebody according to some of the proposals here was able to get an exclusive license to further develop, refine, and put it on the market, by the time they would do that, the Government would give them the license, for a period of 2 or 3 years, and they wanted to spend $200,000 or $300,000 on it, somebody else might come along with another drug or an improved product that would destroy their market for this one. Now, who gains and who loses by that sort of thing? Dr. SEEVERS. Well, my feeling is-and this is not derogatory of the Government-that by the time this gets through the wheels of redtape, there would be two or three new drugs on the market that would be better than the one that they had a patent for. Senator MCCLELLAN. Well, this is the point I am trying to examine: Although the Government may have made a contribution to the processing and exploration that discovered the drug, the formula, the compounds, however you refer to it, although it may have made a contribution, that is the taxpayers' money, now you have the thing and it becomes a discovery, a patentable discovery that may have useful benefits, and the Government takes it. As you point out, by the time a private firm could get that drug well advertised and on the market, and so forth, some new one may actualy have come out that would be a great improvement, to the extent that this one no longer would be in demand. Dr. SEEVERS. That is the reason it is such a high-risk industry. But the originator, in whom you are leaving the control now as you propose, would naturally exploit his product, in other words, to try to get it on the market, try to get his money out of it, and try to make a profit out of it before some new drug came along. Dr. SEEVERS. If he does not have any incentive, this will not be done. Senator MCCLELLAN. But if it is given to him, if he owns it for a period of time, if he owns the patent and the control of it, obviously if he spent some money on it, he would undertake to get it on the market as quickly as possible, to recover his investment and to make a profit. Dr. SEEVERS. I think that is a very important point. Because, as I heard earlier from your statement to Senator Morse, a large fraction of the drugs that would be patented would never reach the market, simply because of the facts that I have indicated. They would not be developed. Senator MCCLELLAN. Would there be more of them that never reached the market if the Government took the patents to all of them? Dr. SEEVERS. I don't believe so. Senator MCCLELLAN. Sir? Dr. SEEVERS. I think not. Senator MCCLELLAN. Well, I do not know whether you understood my question. Would there be more or less of them reach the market? Dr. SEEVERS. I would say there would be less if the Government took control. 54-400-65-pt. 2- -14 |