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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. C rating 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?

LEO H. BARTEMEIER, M. D., BALTIMORE, MD.

1. Past member of the National Advisory Mental Health Council. This is a Council set up by law to advise the Surgeon General of the Public Health Service and the National Institute of Mental Health on matters affecting the Public Health Service in mental health. This Council reviews applications made to the National Institute of Health for funds and research and training in mental health and makes recommendations to the Surgeon General as to whether or not such grants should be approved.

2. Past president of the American Psychiatric Association.

3. Past present of the Psycho-Analytic Association.

4. Past president of the International Psychiatric Association.

5. Member of the board of directors of the World Federation for Mental Health.

6. Former professor of psychiatry, Wayne University, Detroit, Mich.

7. Presently clinical associate professor of psychiatry, Georgetown University Medical School, Washington, D. C.

8. Member of the National Manpower Council.

EXHIBIT 8B

Congressman JOHN A. BLATNIK,

AMERICAN MEDICAL ASSOCIATION,
Washington, D. C., March 31, 1958.

Chairman, Legal and Monetary Affairs Subcommittee,

Washington Inn, Washington, D. C.

DEAR CONGRESSMAN BLATNIK: Recently at the hearings in regard to tranquilizers members of my staff felt that the committee had not been sufficiently informed as to policies of the American Medical Association in its publications designed to protect its members from misleading advertising. To clear up this point, I would like to have the following statement from the general manager of the American Medical Association, Dr. F. J. L. Blasingame, become a part of the record. Attached also are copies of the material to which Dr. Blasingame refers in his statement:

“*** all advertising proposed for the scientific publications of the American Medical Association is subject to review by an advertising committee. The committee is guided by the enclosed principles of advertising for American Medical Association publications in determining whether or not the product is eligible for advertising, and whether or not specific claims are permissible. The advice of expert consultants in regard to questionable products or claims is frequently obtained before passing on the eligibility of proposed advertising copy."

Sincerely yours,

THOMAS H. ALPHIN, M. D.

[Reprinted from the Journal of the American Medical Association, July 30, 1955, vol. 158, pp. 1170 and 1171, copyright, 1955, by American Medical Association]

COUNCIL ON PHARMACY AND CHEMISTRY

By authority of the board of trustees of the American Medical Association, the council has terminated the seal-acceptance program in favor of a new program designed to render a better service to the medical profession. The following statement adopted by the council is issued to explain the purpose, guiding principles, and operation of the new program.

R. T. STORMONT, M. D., Secretary.

NEW PROGRAM OF OPERATION FOR EVALUATION OF DRUGS

The rate at which new drugs are being developed and marketed is increasing constantly. Often these new agents are extremely valuable additions to our therapeutic armamentarium; however, many of them are also capable of doing more harm than good if prescribed or administered in an indiscriminate fashion

without full appreciation of their possible harmful effects or observance of necessary precautionary measures. A calculated risk is involved in the use of drugs that have pharmacological effects of any real significance. Therapeutic agents that have a relatively narrow margin of safety or a high index of serious side effects should not necessarily be condemned and discarded completely. The proper use of such drugs often will save life or provide beneficial effects not obtainable with any other means of therapy. The physician has the serious responsibility of weighing the possible harmful effects of a drug against the apparent need for it in the individual patient. Obviously, an appreciation of the valid indications for use as well as the known properties of any new drug is necessary in order to serve the best interests of the patient.

Many pharmaceutical firms recognize their responsibility to the medical profession and endeavor to provide such information in brochures and other literature as is necessary for relatively safe and proper usage of their new drugs. Promotional literature, however, that contains unwarranted indications for use and minimizes or neglects the mention of contraindications, possible serious side effects, and necessary precautionary measures, does not encourage the practice of rational therapeutics.

There is an increasing demand from the medical profession in general for concise and timely reports that contain an authoritative, unbiased evaluation of new therapeutic agents. The former acceptance program of the council served a useful purpose in this regard for many years; however, in this present era of rapid new developments in therapeutics, the work involved in processing for acceptance many different brands of a drug became cumbersome and time consuming to the extent that physicians could no longer be provided with the type of service they desired. Consequently, termination of the seal-acceptance program became necessary in order that the council could embark on an expanded program of operation that would be of much more interest and value to the profession.

Under the new program drugs will be evaluated at the earliest possible opportunity in order to serve the best interests of the profession. As a rule the greatest interest in a new drug occurs at about the time it is introduced on the market for general use. This is also the time when there is the most need for an unbiased report containing information that will aid physicians in the judicious or proper use of such medication. Evidence relating to a new use or significant change in the status of a drug will also be evaluated and reported on as the occasion demands.

Pharmaceutical firms are encouraged to cooperate with the council by forwarding complete data or reports (published and unpublished) of all laboratory and clinical investigations relating to the safety and usefulness of new drugs in order that evaluation reports may be made to the profession at the earliest possible date. Cooperation with the council in the selection of suitable nonproprietary names for new drugs before such agents are ready to be placed on the market is also encouraged.

The former official rules of the council have been superseded entirely by the following description of the new program of operation.

GENERAL PURPOSE

The function of the council on pharmacy and chemistry is to examine and evaluate available evidence relating to the actions, uses, dosage, hazards, and other pertinent properties of drugs and to encourage rational therapy by timely, informative reports to the medical profession.

Special committees appointed by the council also deal with particular matters such as research projects and the toxicologic aspects of pesticides and household chemicals.

PRINCIPLES GOVERNING THE EVALUATION OF DRUGS FOR INCLUSION IN NEW AND NONOFFICIAL REMEDIES

The council evaluates evidence pertaining to the safety and usefulness of medicinal agents offered or intended for use in or on the human body for the diagnosis, prevention, or treatment of disease. Reports of these evaluations are published for the information of the medical profession.

The council considers for evaluation drugs with a single active ingredient or -extracts from a single source. Combinations or mixtures containing two or more active ingredients may receive consideration only if it is deemed desirable to present the council's views regarding any such preparation for the information of the medical profession.

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