business if the doctor insisted that his good will was dependent on ethical marketing practices and the ultimate welfare of the patient as the only objective. There is, happily, a growing concern, which is affecting even our nonmedical press, over the character of some of the drugs being promoted and the manner of their promotion. This concern is largely a result of the methods by which modern publicity is attained-especially as it affects the sale of such doubleedged tools as today's pharmaceutical products. It is a publicity that includes the glowing encomiums, the bold suggestions regarding the value of the wares that are offered, and in general the insistent persuasiveness from which modern advertising techniques seem to have become inseparable. One need not ask what meat our Caesar eats.

As the pharmaceutical industry has become bigger business it has inevitably been drawn into an acceptance-perhaps not always willingly-of these promotional methods of big business, often in violation of that unique phenomenon known as good taste. Such methods carry with them a risk that the legitimate and erstwhile mutually respected partnership between pharmacy and medicine may turn into one in which medicine becomes a junior partner only to the big business of pharmaceutical manufacturing, with its large-scale exploitation of potent and consequently dangerous drugs. For agents that have a dynamic effect on physiologic functions may alter those functions adversely as well as favorably, and their availability carries with it an added responsibility for their

use.

We are all familiar with the three chief methods of publicizing pharmaceutical products: the visit from the personal representative, or detail man; advertising to the physician by direct mail; and that which concerns us most at this momentadvertising in our medical journals, of which there are now some 6,000 in circulation. The relative use of these methods was brought out in a survey of 23 commercial organizations made by Modern Medicine last winter, which demonstrated that 54 percent of their promotional budgets was spent on the detail men, 13 percent on direct mail, and 12 percent on the journals. The remainder was allocated to drug-trade publications, house organs, samples, literature, conventions, television programs, cocktail parties, and so forth.

So far as the value of these three main methods is concerned, that of detailing seems to be generally acknowledged, whereas direct mail, to the number of 3,000 or 4,000 pieces per year per doctor, is said to have passed its peak-happily for both postman and physician. Journal advertising, despite its relatively low place in the budget, is the most substantial of the three methods, for it is the one that achieves a permanent place in the record of medical progress, and it is the only one directly sanctioned by the profession-the one for which we have an obvious responsibility. In regard to the discharging of this responsibility, the Modern Medicine symposium just referred to indicates that advertising in medical journals can be improved in various ways. Thus, the doctor desires and should be given more specific information regarding the products advertised, and their proper use; he desires and should be given authoritative references when clinical claims are made, and he desires and should be given a presentation without superfluous and distracting verbiage, although he, too, like his less dedicated fellows, reacts favorably to an attractive advertising layout. And there is no gainsaying the effectiveness of stimulating displays, and their propriety, so long as the text contains the truth, the whole truth, and very little else.

For the physician cannot surrender to the manufacturing chemists or their advertising agents any part of his responsibility in the treatment of his patient nor should they want him to. It is to their interest as well as to his to put at his service accurate information about the total effects, both beneficial and harmful, of any advertised drug or combinations of drugs, with their dosages, and he should be supplied with reliable and authoritative references to the studies that have been responsible for their acceptance. The importance of this final factor cannot be overemphasized, for it is likely to be the only reliable scientific evidence of the value of a new product.

To see that he is thus served should be at least in part the business of the editor, who is directly concerned with the character of the advertisements that his journal carries, as well as with the indoctrination of his readers by means of its scientific and editorial text.

Different editors, obviously, have varying degrees of responsibility in respect to the actual selection of the advertising material accepted and the manner of its presentation, depending on their relations with the publishers. This responsibility may range from a total insulation from the business policies of the periodical, to the total administration of all its affairs-scientific, literary,

and financial. In the first instance, whether the journal is owned and operated by a publisher for profit or by a society or association as a means of communication with its members and others, the editor is charged only with the oversight of its scientific and editorial content. It is hard to conceive, however, of an editor indifferent to the character of the advertisements carried by the journal for which he is otherwise responsible, and it may be hoped that any editor's readers would expect him to exert, by one means or another, at least some influence on the type of advertising matter that would be permitted to appear.

In the second instance one may envision the other extreme of responsibility, in which the editor is put in full charge of the publication, often society-owned, and is accountable to whoever employs him for the quality of the original articles, the pitch of the editorial tone, the character of the material accepted for advertising, the stability of the financial arrangements and the punctuation of the text, if any. To him goes the blame for the mistakes that he did not anticipate and prevent, as well as the credit for the successes that he did not personally achieve.

The selection of advertising material-the drawing of the line that separates the acceptable from the unacceptable-may reasonable vary with the type of the journal and its readers and the philosophy that may be observed in this respect. What, after all, are an editor's obligations to his readers, to the public and to the advertisers themselves, one of whose duties is to make a reasonable profit, whatever that may be? To what extent shall the physician who reads the advertisements be protected against his own enthusiasm if he chooses to take too literally all the suggestions that reach him in such glowing terms, and to prescribe indiscriminately drugs the action of which he does not understand, and the ill effects of which may have been insufficiently emphasized? To what extent shall the public be protected against the manufacturer who has invested several million dollars in the production and marketing of a tranquilizer, and against the physician who is too easily persuaded to help him in this benevolent project?

To what extent must the editor be concerned over the fact that the financial solvency of his journal depends on the goodwill of the advertiser, and to what degree is he protected by the valuation that the manufacturer places on the goodwill of his particular journal? These are questions difficult to answer, and few editors, I presume, would be bold enough to set themselves up as sole arbiters of the acceptability of advertising material. If the final responsibility is theirs they must protect themselves by stated principles and policies and expert advice. The New England Journal of Medicine, the forebears of which had succeeded in surviving a long and independent career under the private but nonprofit ownership of successive small groups of local physicians, had to reappraise its methods of operation when it became the property of the Massachusetts Medical Society in 1921. The society maintains a general oversight of the journal through its representative council, but delegates the actual publication to a committee, which in turn appoints an editor from the membership of the society and assigns to him the responsibility for all the details of the operation. The chain of responsibility is thus reasonably clearly defined, the working staff being accountable to the editor, the editor to the committee and the committee to the council. The matter of the procurement of advertising is an old problem, solved to a considerable degree, after the journal's purchase by the society, through the services of what was then the cooperative advertising bureau of the American Medical Association. This bureau, established to solicit advertisements for the journals of the various State societies, has regularly obtained the greater part of the national advertising contracts for the 35 or so periodicals that have subscribed to its offices.

The New England Journal of Medicine, having achieved by 1954 a widely distributed circulation in considerable excess of the membership of the State society, regretfully relinquished its association with the bureau in order to frame on a broader scale its own policies in respect to advertisements, and to follow its own procedures in this regard. It has adhered in general to the principles established by the council on pharmacy and chemistry of the American Medical Association but with somewhat more liberal interpretations.

The most important of these principles are that advertisements shall not be accepted "which, either by intent or inference, would result in deceiving, defrauding, or misleading the reader; that sweeping superlatives, extravagant statements and unfair comparisons are to be avoided, and that claims for superi

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ority must be supported by sound evidence; that disparagement of competitor's goods is not permissible and that quotations from published papers must not distort the true meaning of the author."

Our own interpretation of these principles, published in each issue, is that copy for advertisements is accepted on the basis of the apparent quality and usefulness of the product and the manner of its presentation; that proprietary names of pharmaceutical products must be accompanied by their chemical, generic or official names; that the quantity of all active substances and the recommended dosage must be stated; and that copy must be factual, conservative, and in good taste.

Although the rule regarding the inclusion of dosages is not strictly enforced, we strongly recommend that dosages be published, and it is certainly to the interest of the manufacturer to provide all the information possible regarding his products, if they are worth such frankness, in view of an annual increment of 400 new items.

The effecting of these requirements is in the hands of a committee of three members of the editorial board. As presently constituted the committee consists of an officer of the medical society, a clinical teacher and investigator, and a clinician with a special interest in pharmacology. All advertisements of new products as well as new copy regarding old products is submitted individually to the members of this committee, who grade it A, B, C, or D, in reference to both the product and the copy.

In product rating, A represents excellence both in principle and in practical therapeutic usefulness. It applies usually to a single drug. B rating represents a product that is acceptable but is not of the most desirable quality either in principle or in therapeutic usefulness; it may contain up to 3 agents. Crating applies to products of questionable therapeutic value, or ones that may simply contain an unnecessary multiplicity of agents. D applies to products that are harmful or possibly harmful out of all proportion to their therapeutic value.

In copy rating, A represents excellent taste, only conservative claims being made; B applies to copy that is in good taste, making reasonable claims; C represents poor taste, with exaggerated claims, and D applies to copy that is in bad taste, making unfounded claims. Thus, a product itself must be at least of a high C rating in order to be considered favorably, in which case the modesty of its presentation may influence the committee in its favor; objectionable claims for a good product cause it to be rejected, unless the producer is willing to improve them. Obviously, no such small group as this committee can familiarize itself with the true value of each of a host of new products. But it can exercise good sense in regard to the propriety of statements made and in judging the reliability of the investigations on which they are based. Nor is it the purpose of its members to impede progress by an excess of zeal in the exercise of the veto. In addition to the sincere and conscientious efforts of its advertising committee, the Journal attempts through its editorial text to promulgate and uphold ethical pharmaceutical standards, which, if universally adopted, would make the taking of medicine a somewhat more conservative and effective exercise than at present. To demonstrate still further its good faith in the matter of drug therapy it publishes each month, under the direction of the advertising committee, a short article pertaining to the correct use of some drug or group of drugs, outlining its advantages and disadvantages. Perhaps if eternity can be extended long enough it may be possible thus to include the entire pharmacopoeia, although there is some question about this, in view of the annual increment of 400 new products. In summary, If I may speak for others as well as myself, we as physicians recognize and appreciate our ancient partnership and our friendly relations with our dynamic friends, the manufacturing apothecaries. We admire their scientific foundations and their genuine philanthropies and appreciate their cocktail parties, where our cups runneth over, but we stand a little in awe of the sinews that they have acquired.

As editors we delight in the revenue from their adventures in competitive advertising, even as we seek to put restraints on its ultrapersuasiveness and keep it within the bounds that medical propriety and a sense of service to humanity have set. Our own first duty is to the public, plainly enough, and so is theirs, for whereas much of modern advertising in general is designed to create a desire where there is no need, that of the drug business should still be patterned on the principle of responsibility to humankind.

A year ago this principle was spelled out at a reception in the Vatican of delegates so an international conference on drugs and pharmaceutical products in which they were reminded that their work “has meaning and value only inasmuch

as it represents a true social service necessary for the subsistence * * * betterment of the living standard of a great number of people."

or the

And with such a statement, we, as custodians of the presse médicale, must heartily agree.

EXHIBIT 7

POINTS OF PROCEDURE FOR GUIDANCE IN ETHICAL DRUG PROMOTION

1

The medical section of the American Drug Manufacturers Association is firmly of the opinion that

We individually and collectively should do everything possible to maintain the highest standards in our activities relating to the development and promotion of pharmaceutical, chemical, biological, and other medicinal products.

Since the medical profession is directly charged with the responsibility of providing the highest possible type of medical care to the American public; and Because the medical profession is best enabled to discharge its obligations to the public if prompt, complete, conservative, and accurate information concerning therapeutic agents is available to it; and

Because the public has a right to prompt, general, conservative, and accurate information concerning such agents after proof of their value in clinical practice has been established.

We believe that:

1. Any statement in promotional literature should be supportable by acceptable scientific evidence.

2. Quotations rfom the medical literature or from the personal communications of investigators or the paraphrasing of such quotations should not change nor distort the true meaning of the author.

3. If it is necessary to include comparisons of drugs in promotional literature, such comparisons should be constructive and made on a sound professional basis.

4. The release to the lay public of information relative to the clinical use of a new drug or to a new use for an established drug prior to adequate clinical acceptance and public presentation to the medical profession of such a drug or use is considered not to be in the best interests of the American public or of the medical profession.

5. The use of trade names of prescription drugs in lay advertising is considered not to be in the best interests of the American public.

6. The appearance of physicians or of actors purporting to be physicians in television or radio advertising or in promtional literature intended for lay attention is considered not to be in the best interests of the American public.

7. The use of statements by a physician or of statements which purport to have been made by a physician in advertising intended for lay attention is considered not to be in the best interests of the American public.

8. Since the development of a new drug is recognized to be the result of the efforts of a scientific team rather than of any one individual, the use of individual names in releases for lay attention should occur rarely.

9. A trademark is private property and can be used legally in promotional literature only with the consent of the owner of the mark.

10. The medical department or the medical consultants of a pharmaceutical firm should review all medical claims and assertions contained in promotional literature prior to their release.

EXHIBIT 8A

RESEARCH PERFORMED BY THE COUNCIL ON DRUGS, AMERICAN MEDICAL ASSOCIATION, AS A SERVICE TO THE MEDICAL PROFESSION

In promoting the science and art of medicine and the betterment of public health, modern medicine moves ahead at a fantastic pace toward better scientific medicine, improved patient care and better health for everyone. How can today's busy physician keep abreast of this medical progress? How can he keep in touch with what's new in scientific medicine as well as in the whole medical

1 Adopted February 5, 1955, by medical section, American Drug Manufacturers Association.

and health realm? This is a staggering task-one that would be impossible for a physician to do alone.

The physician need not stand alone. He has help in this task, help provided by his colleagues who pool their efforts to provide the informational resources and services he needs. Standing ready to help the individual doctor are his county medical society, his State medical society and the national confederacy of these organizations that is the American Medical Association. In all of these organizations the individual physician is the keyman.

In what conditions should I prescribe a new drug? Is it relatively safe to use? Are there dangerous side effects? Are there significant differences between two similar drugs? Are there special precautions I should observe in giving a certain new method of treatment? What are the advantages of one type of therapy over another? Where can I find the most accurate, up-to-date reports on medical research? What new findings in the field of nutrition affect treatment of my diabetic patients, my heart patients?

In medicine one discovery pyramids onto another in a monument to medical progress. Keeping "on top" of this expanding knowledge is a staggering job for a physician. He can't possibly absorb and evaluate all the information on new products, new findings, and new methods which pours into his office daily. Yet he must have the answers to his questions.

American Medical Association makes its greatest contribution to better medicine by providing information which helps physicians answer these questions— by gathering data, correlating it, evaluating and summarizing it—and by channeling it speedily to members.

A number of scientific councils and committees, each composed of leading physicians and experts serving without remuneration, carry on this work with the aid of full-time headquarters personnel. Actually, each council is an information center on its special subject-with its services at the disposal of members, allied groups and the public. Major objective: encouragement of rational therapeutics in medical practice.

"Not for ourselves, but for medicine." This motto of the council on drugs characterizes its efforts over more than 50 years on behalf of better medicine. For years American Medical Association was the only major organization working to insure drug safety and to stamp out quackery and misleading advertising. American Medical Association efforts paved the way for passage of food, drug, and cosmetic laws and for establishment of the Federal Food and Drug Administration, which now oversees drug manufacture.

Now the American Medical Association, through its council on drugs, provides physicians with early unbiased information on all types of new drugs. In cooperation with manufacturers, the council evaluates available scientific evidence on a new drug, then publishes its conclusions regarding reliability, proven therapeutic worth and limitations in the journal American Medical Association and later on in new and nonofficial drugs.

Supplementing its drug evaluation program, the council prepares special reports on the current status of therapy in disease, especially where selection of a variety of drugs is involved, such as in nausea and vomiting of pregnancy and epileptic seizures.

American Medical Association's chemical laboratory, in cooperation with drug manufacturers and the Federal Food and Drug Administration, develops methods for testing new drugs for purity, potency, quality, and tolerances. This program gives physicians, pharmacists, and manufacturers unbiased information on procedures for testing new drugs.

The laboratory and the council on drugs work closely in the annual publication of new and nonofficial drugs and tests and assays for new and nonofficial drugs. These volumes provide a reliable source of information on new drugs between editions of the United States Pharmacopoeia and the National Formulary, appearing at 5-year intervals.

In its expanded program the small but well-equipped laboratory seeks answers to special problems of practical interest to physicians: what are methods for assaying drugs dissolved in oils? What are reliable assay procedures for fructose or for hexachlorophene in soap and cosmetics? How can you determine the presence of sucaryl in combination with saccharin? Do sustained release medications perform as claimed?