to the physician. Such sections should include a list of all available preparations, with or without comment as to their usefulness, composition, rationale, etc. Cross indexing, groupings according to areas of therapy, etc., should be included.

III. OTHER STAFF ACTIVITIES

A. The Department of Drugs will undertake to review, whenever possible, articles on drugs considered for publication in any of the AMA scientific publications, and will handle for J.A.M.A. all questions from physicians pertaining to drug therapy.

B. The Department of Drugs will expand its services for the development of research in areas requiring cooperative efforts of several clinics (i.e., osteoporosis) and in areas outside the interests of other organizations (i.e., tranquilizers, immunological procedures, etc.).

C. To carry out effectively the above proposals the following measures will be undertaken :

(1) Current medical literature must and will be continually and promptly reviewed for new information about drugs, to permit constant revision to keep the council's statements up to date.

(2) The present Registry of Blood Dyscrasias must and will be expanded to include all reported major reactions to drugs, and it must contain built-in controls to provide for the evaluation of the reports received.

(3) A repository file of all available information on drugs must and will be established and maintained as a source for III C, (1) and (2). Although this is essential to the effectiveness and completeness of the long-range program, implementation of the program as outlined in I and II should not await its development. The means to develop an adequate file are being explored currently.

(4) The pharmaceutical industry will be expected to submit data to the council at the time the NDA is submitted to the FDA and continually to provide all available information on single-entity products and other drugs evaluated by the council under its existing policies, to facilitate the prompt publication of current and authoritative council statements.

(5) Much more extensive promotion of the council's program, including the drug information repository and the registry of reports of toxic reactions to drugs, and its publications, both NND and the statements in journal, will be undertaken.

EXHIBIT B

A PROPOSAL TO THE UNITED STATES PHARMACOPEIAL CONVENTION FROM THE AMERICAN MEDICAL ASSOCIATION ON A COOPERATIVE PROGRAM FOR THE SELECTION OF NON PROPRIETARY NAMES FOR DRUGS

The objectives of the proposal are to facilitate the selection of a suitable nonproprietary name for each single entity drug and to encourage the use of such selected names wherever indicated in labeling, in advertising, as titles in the official compendia, and in the scientific literature.

A joint committee, to be known as the "Nonenclature Committee of the USP and the AMA," will be established to negotiate with the manufacturers. This committee will consist of four members. Two members are to be nominated by the AMA subject to the approval of the USP; the other two members are to be nominated by the USP subject to the approval of the AMA.

The American Medical Association will maintain for the committee and expand, as necessary, its present staff and facilities for receiving proposals of nonproprietary names from all sources, will process these proposals and initiate and conduct such negotiations as expeditiously as may be appropriate to settle upon a tentative name for all new drug entities.

It may be expected that in a given number of nonproprietary name negotiations the USP-AMA Nomenclature Committee and the manufacturer (s) may fail to reach an accord satisfactory to each. The USP will appoint a board, to be known as the nomenclature review board, to determine the merits of such cases and to make a final decision thereon. This board will act upon the request of either the committee or the manufacturer (s) involved.

The nomenclature review board will consist of five individuals of judicial temperament and highly respected status in medicine and pharmacy; the AMA

will recommend to the USP several names of potential candidates from which list two members will be selected by the USP to serve on the board. The terms of board members would overlap to insure continuity. One member will be added to the board, on an ad hoc basis but without vote, to represent the firm making the protest. If more than one firm were involved, an ad hoc member from each will be added. The board will function primarily through correspondence.

The decisions of this board, which will be final for this stage of the negotiation, will be reported to all interested parties.

Tentatively adopted (as a result of above action) nonproprietary names will be referred to the cooperating agencies (N.F., WHO, B.P. Commission, French Codex, Nordic Pharmacopeia) for their consideration and comment, in accordance with the present policy leading to the final adoption by the committee for national use in the United States.

Names adopted by this nomenclature committee will be the designations used in the Council on Drugs (AMA) monographs on individual drugs and will be the nonproprietary names used in the scientific journals of the AMA. The AMA will promptly notify the editors of medical journals and the professors of pharmacology of all medical schools in the United States of the adopted name. The USP (1) will adopt the names so selected as the USP titles when and if the articles concerned are admitted to the USP; and (2) will undertake to publish lists of the names at frequent intervals through appropriate channels.

It will be made clear, of course, that adoption or publication of the name implies no endorsement whatever, by the committee, the AMA, or the USP, of the merits of the articles to which the name applies.

Both the USP and the AMA will make reasonable effort to notify the industry and the professions of medicine and pharmacy that the committee maintains this invaluable service on the common names for drugs. The committee will also undertake to notify other national and international agencies of the names selected.

The USP will organize a concerted campaign to acquaint the editors of all medical and pharmaceutical journals of this service and the availability of nonproprietary names for all drugs that are likely to be the subject of published articles. Efforts will be made to encourage the Food and Drug Administration and the Federal Trade Commission to extend their respective areas of authority to the limit in seeing that the selected names, and only those, are used whereever nonproprietary names appear in drug labeling and advertising.

In the name of the committee, the AMA staff will maintain all contacts in connection with the process of selection and negotiation as at present, including all participating in the World Health Organization program.

Senator KEFAUVER. Thank you, Dr. Hussey, for your statement. Would it be fair, Dr. Hussey, to conclude that the American Medical Association is unable to find any provision of this bill, S. 1552, that is defensible?

Dr. HUSSEY. On some of the provisions of the bill, Senator, the AMA has not a position to propose.

Senator KEFAUVER. I can understand that.

Dr. HUSSEY. Yes, sir.

Senator KEFAUVER. But I mean, on any provisions that you do have a position on, you cannot find any one of them that you can give your support to?

Dr. HUSSEY. Otherwise not, sir.

Senator KEFAUVER. You do find many things that ought to be done, many improvements that ought to be made, and some of these have been brought out in the last 2 or 3 weeks at your last meeting, which you have described in your statement. We are glad that you are taking some action in the matter.

But on these improvements that can be made, you think that they can best be made by the American Medical Association working with the U.S. Pharmacopoeia and with the drug companies?

U.S. P.-A. M. A. COOPERATIVE NOMENCLATURE PLAN (APRIL 3, 1961)

U.S. P. also will publicize program itself and seek out recognition of these activities from both F. D. A. and F.T.C.

Dr. HUSSEY. And with the Food and Drug Administration, did you say, Senator?

Senator KEFAUVER. No, with the drug manufacturers.

Dr. HUSSEY. For the provision of nonproprietary names, the cooperation of the manufacturer, U.S. Pharmacopoeia and the AMA Council on Drugs is envisioned.

Senator KEFAUVER. And more specifically the house of delegates by resolution which you have referred to, has opposed the provision requiring the Food and Drug Administration to determine the usefulness of efficacy as well the toxicity of drugs?

Dr. HUSSEY. That is correct, sir.

Senator KEFAUVER. Mr. Flurry will you ask more details about this, but what has happened that has caused you to change your position since 1950 about deciding upon the efficacy or usefulness of drugs?

Dr. HUSSEY. I was not aware of a change of position in respect to a statement regarding efficacy, Senator.

Senator KEFAUVER. In its 1950 rules, the AMA Council on Drugs expressed disapproval of useless drugs. Rule 7 is entitled "Unscientific and Useless Drugs."

It states:

A preparation or an article will not be accepted if in the opinion of the council it will not be in the best interests of rational medicine and the public. Useless drugging is apt to be harmful. This precludes the acceptance of articles which have no definite therapeutic value, of compounds or mixtures with an excessive number of active ingredients or with ingredients that are of no probable assistance to each other, and of articles which involve dangers of toxic effects disproportionate to their therapeutic value.

That is the AMA Council on Drugs Resolution No. 7, and it is further backed up by many statements.

Dr. HUSSEY. I would back it again, Senator.

Senator KEFAUVER. Particularly under the direction of Dr. Austin Smith when he was head of the Council on Drugs of AMA.

Dr. HUSSEY. None of us want to see useless drugs put on the market. It is in the body of my direct statement to you. It is to be prevented in every possible instance.

Senator KEFAUVER. Why did you change your position about it? Dr. HUSSEY. I do not consider that this is a change of position.

Senator KEFAUVER. How do you reconcile your view that the physicians themselves, out of their own practice, rather than somebody else-rather than a Food and Drug Administration-ought to pass on whether a drug is useful and efficacious?

Dr. HUSSEY. The point here is that the decision on efficacy is something that is subject continually to revision and even to redirection. On the matter of revision, a drug proposed for a new drug application to the Food and Drug Administration might be approved for marketing because it is safe and at the same time the manufacturer has provided evidence that would indicate that the claims he makes for it are justified.

When the drug reaches the market and undergoes further clinical use, either in a special testing technique or more widely by the profession, it may be found to be much more efficacious than had originally been anticipated or less efficacious.

On the matter of change of direction, a drug arrives on the market and is claimed to be, let us say, a diuretic. Let me give you a specific instance. Chlorthiazide, known to have properties as a diuretic and providing relief of edema, was marketed for that purpose. Early in its career of use early in its use by the profession-it was found to have rather remarkable antihypertensive effects. Its popularity in that respect far exceeded in fact its popularity as diuretic.

This was a change in direction that was not anticipated at the time the drug first underwent study.

Senator KEFAUVER. On page 16 of your statement at the bottom you

say:

The marketing of relatively useless drugs is less serious than would be the arbitrary exclusion from the market of a drug that might have been lifesaving for many persons.

Then rule 7 of the new and nonofficial remedies of 1950 is what I have just read you which denounces the sale of drugs that are not useful.

Reading again:

Useless drugging is apt to be harmful. This precludes the acceptance of articles which have no definite therapeutic value, of compounds or mixtures with an excessive number of active ingredients or with ingredients that are of no probable assistance to each other and of articles which involve dangers of toxic effect disproportionate to their therapeutic value.

So that does seem to be a complete turnaround to me.

Dr. HUSSEY. Perhaps Mr. Stetler can speak more directly to the point, Senator.

Senator KEFAUVER. Mr. Stetler is the AMA counsel?

Mr. STETLER. Yes, sir. Only two points I think might be made in connection with the rule you raise. One is the time at which this rule was applied. It would not be applied at the time of the filing of a new drug application, but later after physicians had had some mass usage of the drug.

Secondarily, I think it is important to look at the effect of a suggestion by the American Medical Association with respect to what might be decided even to be a useless drug. This does not prevent the drug from being marketed. It does not take it off of the market at the time when the drug was first put on the market-when the new drug application is filed-as would be the case if this authority were placed in a governmental agency, such as the Food and Drug Administration.

I think the difference is a question of when the decision was made and by whom it is made.

Senator KEFAUVER. Of course if other information shows as time goes on that a drug is useful, or if further research shows that the Food and Drug Administration did not have the full facts on which to act, they can always change their mind and allow the use of the drug, Mr. Stetler.

Furthermore, don't you have a question of legal liability when individual doctors experiment with useless and noneffective drugs?

You wrote an article in which you talked at length about that yourself, Mr. Stetler.

Dr. HUSSEY. I wish we could talk about drugs that are effective because this is what we are really concerned with.

Senator KEFAUVER. We will get around to that.

But Mr. Stetler's article was published in the November 30, 1959, issue of the AMA News. It says:

CAUTION ADVISED IN DRUG TESTING

A physician who tests drugs for pharmaceutical firms on his own patients would be wise to use utmost caution from the medical and legal standpoint. This is from your article, Mr. Stetler:

This advice comes from an attorney for the AMA Law Division who acknowledges that the benefits of testing new drugs are of great importance and that physicians are doing a service by cooperating with responsible pharmaceutical manufacturers.

At the same time, the attorney emphasized, the physician's first responsibility is to his patient and he should not prescribe a drug whose effect may be unknown if a known and proven drug is available.