Future Role of the American Drug Industry, The. C. Joseph Stetler. J. Omaha Mid-West Clinical Society, 25: 18-20, January 1964. Presentation of PMA's executive vice president and general counsel at Omaha Mid-West Clinical Society, October 31, 1963. Government and Industry Relationships: Their New Impact on Medicine. John T. Connor. Military Med., 128: 510-515, June 1963. Address of Merck's president to Texas Medical Association, Jan. 19, 1963. Health Industry, The: Eleven Years of Growth. Edmond Thayer, Jr. Health Presenta James D. Gallagher, M.D. South Dakota J. Med. & Pharmacy, 17: 38-42, April 1964. tion by Lederle's director of medical research to American College of Neuropsychopharmacology, Washington, D.C., Jan. 16, 1964. Impact of New Drug Regulations on Teaching and Research in Medical Schools. William M. M. Kirby, M.D. J. Med. Education, 39: 355-359, April 1964. Controversial presentation by the University of Washington professor of medicine and chairman of the AAMC Committee on Study of New Drugs at annual meeting of American Association of Medical Colleges (and elsewhere), Chicago, Oct. 28, 1963. Introduction to Clinical Investigation, Kenneth G. Kohlstaedt, M.D. J.A.M.A., 187: 344-347, Feb. 1. 1964. The author is executive director, Lilly Research Laboratories. Kefauver-Harris Amendments, the Pharmaceutical Industry, and the F.D.A., The. Med. Times, 92: 1-7, January 1964. The editor reports the answers he received to provocative questions, and calls for "mutual confidence and politeness" between industry and the FDA. Legal Considerations in Drug Research. Austin Smith, M.D. Clinical Pharmacology & Therapeutics, 4: 704-708, Nov.-Dec. 1963. Presentation of PMA's president to American Therapeutic Society, Atlantic City, N.J., June 14, 1963. Liability in Use of Investigational Drugs. George E. Schreiner, M.D. J.A.M.A., 185: 259-263, July 27, 1963. This Georgetown University clinical investigator believes he and his colleagues, "once in a legal limbo" are "now out on a legal limb." Living in a Glass House. Eugene N. Beesley. Texas State J. Med., 59: 937-938, October 1963. Address of Lilly's president at 1963 annual session of Texas Medical Association. Medical and Legal Responsibility in Clinical Research. William Furst, M.D., and William Furst, LL. B. J. Med. Society New Jersey, 60: 229-231, June 1963. A report presented at the 1960 meeting of the American Psychiatric Association. Medical Care: Its Social and Organizational Aspects. Role of the Pharmaceutical Industry in Modern Medicine. Alfred E. Driscoll. New England J. Med., 270: 286-289, Feb. 6, 1964. A thoughtful article by the president of Warner-Lambert Pharmaceutical Company. Medical Ethics and Controlled Trials. Austin Bradford Hill, C.B.E., F.R.S. British Med. J., No. 5337, pp. 1043-1049, April 20, 1963. A widely discussed lecture given by a University of London professor before the Royal College of Physicians. Medical Liability in Drug Trials. Francis Boyer. New England J. Med., 270: 777-778, April 9, 1964. The author is chairman of the board, Smith Kline & French Laboratories. New Dimensions of the Pharmaceutical Industry, The (editorial). Rowland B. Kennedy. J. Mississippi State Med. Assn., 5: 167–168, April 1964. The editor cites the de Haen report in Drug Trade News. No Absolute Safety. Partial FDA statement before House Subcommittee on Pharmaceutical Industry, The: What it is and What it does. H. W. Palmer. Proceedings Royal Society Med., 56: 547-554, July 1963. The author is an executive of the Glaxco Group, Ltd., London. Pharmaceutical Services, The: The Industry's Contribution. J. C. Hanbury, F.R.I.C. Royal Society Health J. (London), 83: 71-73, March-April 1963. The author is chairman of Allen and Hanburys, Ltd., a British drug company. Professor Chain and Drug Manufacture (editorial). Applied Therapeutics (Toronto), 5: 723-725, September 1963. Excerpts from an address by the codiscoverer of penicillin who warned that if there is "no pharmaceutical industry *** (there will be) no new drugs." Progress in Drug Therapy-1963. Austin Smith, M.D. J. Practical Nursing, 14: 22-23, January 1964. A review of the year that was by PMA's president. Question of Drug Safety, The. Austin Smith, M.D. Iowa Pharmacist, 18: 19-20, March 1963. A report by PMA's president to National Pharmaceutical Association, August 7, 1962. Regulations Affecting Drug Research and Development: A Historical Perspective. Theodore G. Klumpp, M.D. J. New Drugs, 3: 212-220, July-Aug. 1963. Presentation by Winthrop's president at Conference of Professional and Scientific Societies, Chicago, June 28, 1963. Responsibility for Testing Drugs in Humans. Harry F. Dowling, M.D. J.A.M.A., 187: 212-215, Jan. 18, 1964. The chairman of the AMA Council on Drugs reports from the University of Illinois Research and Educational Hospitals, and the department of medicine of the College of Medicine. Responsibility of the General Practitioner for New Drugs, The. Dr. Russell Taylor. Applied Therapeutics, 6: 13-15, January 1964. The author is in the department of pharmacology, University of Toronto. Rules, Regulations and Research. Oliver J. Neibel, Jr. New Physician, 12: A-85-A-87, December 1963. FDA is subject of executive director of College of American Pathologists at first annual House Staff Symposium, Chicago, May 1963. Seminar on the Clinical Evaluation of Drugs: The Protean Control of Clinical Pharmacology, Walter Modell, M.D.; Patient Selection and Stratification in Therapeautic Trials, D. R. Laurence, M.D.; What Does the Laboratory Worker Expect from Clinical Trials? Hubert Bloch, M.D. Clinical Pharmacology and Therapeutics, 4: 371-392, May-June 1963. Presentations made at a meeting of the American Federation for Clinical Research, Baltimore, Dec. 13, 1962. (Reprints available only from the publisher). Seminar on the Clinical Evaluation of Drugs: Clinical Applications of Sequential Analysis-An Introductory Review. Chr. L. Rumke, M.D. Clinical Pharmacology & Therapeutics, 4: 531-541, July-August 1963. The author is a member of the faculty, Free University, Amsterdam, Netherlands. Study of New Drugs, The (editorial). Med. Tribune, 4: 15, Nov. 25, 1963. Comments of study of investigational drug regulations made by Dr. William M. M. Kirby of University of Washington. Symposium on the Efficacy of New Drugs. Howard F. Conn, M.D. Med. Clin. N. Amer., 48: 253-570, March 1964. A notable group of specialists have contributed 19 papers to the coverage of this timely subject. Testing Drugs on Man (editorial). Pennsylvania Med. J., 66: 71, August 1963. The editor advocates reporting of drug reactions, and mentions a new plan for drug retrieval when it is necessary. Mr. FOUNTAIN. Thank you very much, Doctor, for your supplementary statement. At the time we had to bring our early hearing to a close, we were discussing the association's position on Government support of medical research. It was your position, I believe, that Government funds should be directed principally to basic research and that drug development should be left to the pharmaceutical industry. Does this no longer represent the position of your association? Dr. SMITH. NO. That statement essentially represents, if I understand the question correctly, sir, it represents the position of the association; namely, that the Government should be concerned primarily with basic research and industry with the more practical demonstration of its usefulness, working with Government and with other scientists. Mr. FOUNTAIN. My reason for asking that question is that I understood from your supplementary statement that you have a revised policy statement presently under review by your board of directors.1 1 A copy of the statement appears on pp. 302-804. Dr. SMITH. It doesn't change the opinion; it merely changes the wording of the earlier statement, Mr. Chairman. The views will be essentially the same. Mr. FOUNTAIN. I see. In your supplementary statement you characterize as inconsistent, the view that the public cannot be an arbiter with respect to the effectiveness of drugs, but that the public can control decisions with respect to their adverse effects. I would certainly agree with you that we should not accept the principle that the FDA should base scientific decisions upon arbitrary and illogical public opinion. However, I wonder if you interpreted Commissioner Larrick's testimony on limiting the risks of drugs in the way in which he intended it, or at least the way in which I understood it. It appears to me his statement was to the effect that society might possibly attempt through appropriate legislation to obtain absolute, or as nearly absolute as possible, drug safety, rather than that the FDA would react to public opinion in individual cases. In other words, the public reaction to something can become so severe, and the impact of that public opinion upon duly elected public officials can be so great, that an attempt might well be made to go even beyond what we, sitting here coolly and calmly, think should be done. That is the way I interpreted his statement. Dr. SMITH. We took the words as they appeared in type, and as they were commented on by others who had reason and opportunities to read these. And as they are in cold type, they convey a meaning to us which was disturbing. Mr. FOUNTAIN. Mr. Moss? Mr. Moss. Mr. Chairman, on that point, I think this is a grave danger always encountered when one takes from context part of a statement. The full statement was: We seek to make decisions about drugs solely on the basis of scientific consideration but over a period of time the direction of Government's decisions will inevitably be influenced by public reaction. The public has developed a growing interest in drug matters. The public is making judgments. Now, then, we go into what you quote: The judgments of society are not necessarily consistent with scientific facts, neither are they always logical. After that paragraph, he says-and you cut the paragraph short in your quote, because he goes on from the last sentence: If it should become the overwhelming public view that society should drastically limit the risk, no matter how much good a drug can do, then we would be forced to remove from the market many drugs whose good far outweighs their harm. Carried too far, such developments would seriously impede the progress of medicine. I think it is very clear from those words that we were being given a great truth. I serve on the committee that wrote the last bill and I can assure you there is a strong public interest, and a strong public reaction, and I can also assure you that that public expression cannot be ignored and is not ignored by government. In the final analysis, it is not ignored by you, because when industry senses that it is faced with the alternatives of making a proposal of its own to allay public fears, or accepting a more extreme position, it is going to move to modify the existing posture in order to gain ground. That is the only wise thing it can do. I see nothing here that is inconsistent from the standpoint of regulation. It is a recognition of the fact that we have representative and responsive government. And if the public is very stirred up, as they were at the time we considered the last drug bill, their demands are frequently going to go much further than our judgments are going to support them in the committees. But the impact of those demands are going to be clearly evident in deliberations of any committee of his Congress or any representative body in government. Mr. FOUNTAIN. Do you care to comment, Dr. Smith? Dr. SMITH. Mr. Chairman, Congressman Moss' comments are most reassuring and I believe this is what we would expect from any congressional committee or subcommittee. I would also say that we did not take the quoted material out of context nor did we attempt to take out of context the thought in such material. Congressman Moss refers to the fact that public opinion may influence considerably the actions of industry and I think implied that large segments of the industry, if not the whole of industry, was involved when serious emotional as well as scientific matters are stirred up before public view. The thought or the words that bothered us-and I would like to read them again: Then we would be forced to remove from the market many drugs whose good far outweighs their harm. You see, it is the administration that is speaking and not a subcommittee. Mr. Moss. But, Doctor, that refers, in context, to a statement I think that is very true on its face; over a period of time the direction of Government's decisions will inevitably be influenced by public reaction. If that influence is then exerted, we would be forced to do this, and he goes on further to say that carried too far, such developments would seriously impede medicine. He recognizes the same inherent danger you do. I submit this is not in any sense an inconsistency. I think it is as much a statement of truth as you could possibly devise. I think there is no improper motivation, no desire to grasp for a procedure other than one soundly based on science. Rather it is an alerting of all of us to the fact that public indignation can change these things. Dr. SMITH. Well, we were not implying-I would like to make this clear that the administration would attempt to seek more than it should in its actions. I think perhaps, Mr. Chairman, it is a question of our inability of words to convey to all the same thoughts that may be bothering us at the moment. For example, I am thinking of the individual drug that might be removed, and I feel sure, Congressman, you are thinking about, say, classes of agents or perhaps general approaches to treatment or to diagnosis that may arouse public opinion. In such cases we both are thinking in terms of a procedure in those situations. However, here I am focusing my attention on the individual drug which may be inconsequential in the future. But because we did feel since others interpreted this as we did, that this was worthy of further comment and your attention. Dr. KLUMPP. Mr. Chairman, there was the possibility in that statement that the Food and Drug Administration, in a specific instance or class of instances, might be forced by public opinion to make wrong decisions. Therefore, we felt very strongly that such decisions should be based on reviews of experts and on the facts, and that, when those facts are clear, and those views are soundly conceived, the blowing winds of public opinion should not be permitted to sway soundly conceived positions. Dr. SMITH. I think, Mr. Chairman, that perhaps Congressman Moss may have assumed we were directing criticism against the Food and Drug Administration, or against the Commissioner. What we are really trying to say in part is that a body which makes its decisions on the basis of scientific evidence, should not be forced because of public opinion to make decisions that fly in the face of such scientific evidence. Mr. Moss. Doctor, I think I should make very clear what I felt occurred here. You cite this as an example of regulatory opinion. Am I correct on that? Dr. SMITH. That is right. Mr. Moss. And I submit it is not in any sense a statement of regulatory policy, but rather an alerting of a very clear cold political fact; that if the public becomes sufficiently stirred up, if the public demands, even though the demands may not coincide with good sound scientific judgments, that under our system of government, government can in response to those demands adopt highly restrictive laws. Now, that is what the Commissioner was saying, and I say that is true. I know that many of you gentlemen feel that the Congress responded in precisely that fashion when the Delaney amendments were adopted. I know that we considered other proposals in committee at the time of writing the last drug act, which you would have placed in the same category, had they been successful. But I do also know that there was strong public support for it. Had it been a little stronger, they may well have ended up in the legislation. I can cite one that you are quite familiar with, the demands that no person be given any drug, experimentally, without his written consent. Now there is a very strong public demand for such a policy. It is resisted by, I imagine, your organization. It certainly is resisted by the practitioners of medicine. And they offer a very persuasive case. But a couple of dramatic instances of damage in the use of drugs experimentally could again touch off a public demand which might be too strong to ignore. That is the way I interpret this statement, as an alerting, a sound bit of advice, rather than a statement of regulatory policy. He doesn't say the agency is going to do this. This in context clearly refers to Government and Government action. Dr. SMITH. That is reassuring. Mr. Moss. His agency is bound by law, their actions are subject to review. If it is too arbitrary or capricious, you can have it set aside. That is the safeguard we have written into the grant of authority to these agencies. But the statement doesn't, in my judgment, bear any resemblance to a policy statement. Mr. FOUNTAIN. I would like to say I concur wholeheartedly in what Congressman Moss has said. I also did not get that interpretation. However, I don't think that we can overlook the fact that human beings at times are subconsciously impressed by things and don't |