This statement has been prepared in response to an invitation from The Journal of Medical Education. There are a number of questions and problems of mutual interest to teaching members of the medical profession and the pharmaceutical industry, and, since lack of understanding and confusion apparently have contributed to the questions, the authors of this article have attempted to bring together some explanations and comments that concern areas about which there seems to be the most misunderstanding. Perhaps some historical background will be helpful.

The Pharmaceutical Manufacturers Association (P.M.A.) is the successor to two predecessor organizations, the American Pharmaceutical Manufacturers' Association, started in 1910, and the American Drug Manufacturers Association, which began in 1913. It was created in 1958 and has 140 members, each of whom is involved primarily in the manufacture of products for prescription use and who collectively make up more than 90 per cent of the total volume of pre

* Authors: John G. Searle, President, G. D. Searle & Co.; L. D. Barney, President, Hoffmann-La Roche Inc.; Francis Boyer, Chairman of the Board, Smith, Kline & French Laboratories; George R. Cain, President, Abbott Laboratories; Lyman C. Duncan, General Manager, Lederle Laboratories Div. of American Cyanamid Company; Robert A. Hardt, President, Armour Pharmaceutical Company; D. Mead Johnson, President, Mead Johnson & Company; E. Gifford Upjohn, M.D., President, The Upjohn Company.

scription products in this country. It has a comparatively large board of directors (27 members) and a president who is a physician and who for years worked closely with medical organizations, medical teachers, and researchers. The P.M.A. in addition has about 80 committees and subcommittees, more than half of which are involved in scientific interests ranging from blood dyscrasias to research control procedures for laboratories. The membership of these committees consists, of course, of scientifically and professionally trained people who are associated with the Member Firms. One very important aspect of the work of the P.M.A., which incidentally is in part a trade association and in part a professional association, is the avoidance of any act which would be considered illegal. The courts today are keenly watchful for any sign of an activity which might be in violation of a law, for example, in restraint of trade.

SEEKING ADVICE

About 2 years before the P.M.A. was born two representatives from the A.D.M.A. and two from the A.P.M.A. met with four representatives from the American Medical Association to discuss subjects of mutual interest to physicians and pharmaceutical firms. Other meetings subsequently were held. This liaison effort continued after the birth of the P.M.A. and led to the creation of a special committee of the Board of Directors. It is known as the Professional Relations Committee, and its members for 1960

1961 are the authors of the present report. Since its creation this standing committee has met on several occasions with representatives of the American Medical Association, with the Association of American Medical Colleges, and twice with the New York Academy of Medicine. Other meetings will be held with these bodies and with other medical and professional groups as time permits and as such meetings can be scheduled. In fact, P.M.A. officers are now meeting informally with others in preparation for such meetings. Always dominant in the discussions have been attempts to ferret out problems of mutual interest with a view to determining how these can be resolved. Two examples of the results of such probing may be of interest to the readers of this article.

One of the suggestions offered by the A.P.M.A. and A.D.M.A. representatives to the A.M.A. called for a detailed depth study of the attitudes of physicians toward the pharmaceutical industry. Truly desired was some knowledge obtained from an independent source so that likes, dislikes, suggestions, and areas needing clarification could be set forth. The A.M.A. unhesitatingly sponsored such a study independent of the industry, and when completed the study was turned over to the industry without restriction. Whereas many surveys have been made independently of and also by pharmaceutical firms, the A.M.A. study contained invaluable information for review and guidance.

Another example of the value of this exchange of ideas lies in the development of a set of guiding principles by the A.A.M.C. and P.M.A. In substance these principles are concerned with surveys of medical students, non-educational entertainment, awards and prizes, lectures, visits to pharmaceutical laboratories, printed literature, and drug specimens. Their usefulness and the spirit behind

their development are evident in a report rendered before the A.A.M.C. assembly at its recent meeting. To quote in part from this report: "After a year's experience . . . although there have been instances where both schools and industry have acted to the contrary, the committee feels that much progress has been made in relieving the problems toward which it is directed."

As these and other meetings have progressed it has been apparent that there is much confusion about what the primary objectives of the pharmaceutical industry are, what its association, the P.M.A., is organized to do, what the laws provide for marketing drugs, and how it is attempting to meet its obligations as part of the medical care team and as a responsible component part of good citizenship. While the industry has been seeking advice and has been sharing the results of its efforts, and while numerous organizations and many individuals have offered cooperation and at the same time sought information about the industry's way of life, there have been others, unfortunately, who have written and spoken apparently without the benefit of this knowledge. Some of the seemingly less well known facts are important, though, to educator, practitioner, student, researcher, and, for that matter, citizen. In view of the fact that the pharmaceutical industry is probably one of the most, if not the most, regulated industries in the U.S.A., the sharing of some pertinent information may be helpful to the Journal readers.

ADVERTISING

Perhaps the most misunderstood industry activity is its advertising. There are some not associated with the industry who seem to confuse promotional efforts with educational efforts, whereas actually the members of the P.M.A. do not consider their advertising to be educational but merely informative. Promotion ob

viously is important for sales and the lowering in cost that usually is associated with volume production. Advertising of drugs is intended to arouse the doctor's curiosity, to acquaint him with new products or dosage forms or uses, and to encourage him to ask questions. It is not intended to urge the physician to act without adequate knowledge. Not only do the physician and his patient suffer, but the firm behind the product involved suffers when drugs are used improperly.

Sometimes there is confusion, so it seems, about how advertising claims are developed and censored. Of course, claims are based on the evidence developed by researchers, most of whom are in some way identified with academic circles. At times researchers do differ in their appraisals, but if the work of one man is more sound than that of another the fact usually is apparent. The evidence then is submitted as part of what is known as a "new drug application" which is presented to the Food and Drug Administration before a new drug can be placed in interstate commerce. Included in this presentation is what is commonly called an "official brochure"; it contains a description of the chemistry, pharmacology, and therapeutic usefulness of the drug. If adequate evidence is not available to support the claims, the F.D.A. says so. Incidentally, this brochure is available on request for physicians, pharmacists, and others who have a right to such information. If a new claim subsequently is to be advanced the new drug application is supposed to be amended before the claim is made in future labeling.

Advertising copy is based on the claims permitted in the "official brochure." Members of the P.M.A. subscribe to a belief that such copy should be reviewed by a medical department or consultant physicians. In fact, this is set forth in the statement of principles of ethical drug promotion adopted by the

P.M.A. in 1958. Contrary to the statements made by a few critics during the past months this is a common practice. In addition, advertisements prepared for medical journals are reviewed by offices or committees organized by the journals for this very purpose. Outstanding examples are the journals published by the American Medical Association and the state medical journals. Others could be mentioned if space permitted. Obviously there are times when not all readers of a journal may agree with all the statements in the advertisements any more than they will agree with all the statements in the scientific papers of the journal, but this represents difference in judgment rather than preplanned deception. Certainly an advertiser cannot "buy" his way into such reputable journals even if he were so inclined. Editors are well chosen in general and have important and informed men advising them constantly. If such were not the case the parent medical organization of an offending journal would soon bend to the complaints and wishes of its members. In fact, members of medical journalism meet frequently to discuss methods of improving communication with their readers.

Often one hears "there is too much advertising." Perhaps this is true, but what is too much? The advertiser knows when the return does not justify the expenditure for promotion, but neither he nor those responsible for a medical journal know when an advertisement has eased suffering, or even saved a life, because a reader was reminded of the availability of a drug or dosage form as he contemplated the handling of a seriously ill patient. No doctor reads all advertisements, only those that interest or appeal to him. Some direct mail pieces likewise may not be necessary; which of these are expendable might be difficult to judge at times. The best judgment fol