Mr. WALLACE. And that problem is going to exist irrespective of where responsibility lies in naming the drug. We have that problem and we have to live with it. It does not make much difference who is in control.

Dr. DOWLING. You used the words "live with it," sir. I would say that if you have a problem of crowding in a house, you find a larger house where you can distribute yourselves properly and you do not have the problem any longer.

You have the problem of moving; you have the problem of adjusting yourself in the new house; but you have a better system once you get there.

Mr. WALLACE. I think Dr. Goodman also testified that he does not think that the drug companies sit up nights thinking of long names for the drugs. Would you agree with that?

Dr. DOWLING. I would agree that we are not blaming the drug companies necessarily for the problem. The problem is a problem of complexity of names. The problem is a problem of communication, which is a problem we have in every branch of science at the present time, as everyone here knows. But when one has such a problem, one must tackle the problem at its roots.

Senator KEFAUVER. I have stated before, Dr. Dowling, that we would certainly hope--and, as far as I am concerned, I want to put in the record or even in the bill-that the voluntary efforts of the U.S. Pharmacopoeia and the AMA's Council on Drugs would continue, and that the Food and Drug Administration, in having the final power, would come into the picture when the USP and AMA's Council on Drugs were unable to get a satisfactory name or when the drug company was recalcitrant and would not agree to any name that they suggested; that then there would be power reposed in the Food and Drug Administration to settle the dispute and to assign a name; and the very existence of that power would bring about better cooperation; would it not?

Dr. DOWLING. Indeed it would.

Senator KEFAUVER. Any other questions on this subject?

Senator Hart has conducted the hearings on generic and trade names and he is a real expert on it.

Senator HART. Thank you.

I will not ask anything that would destroy your description of me. Senator KEFAUVER. He is a real expert with a good sense of humor,

too.

Very well, let us proceed.

Dr. DOWLING. I have mentioned so far the provisions of the act as they apply to physicians. Anything that would improve the practice of medicine would benefit the patient. If more adequate tests are done to determine the efficacy of a drug, the patient benefits; if claims for a drug coincide with proved accomplishment, the patient benefits, and if the doctor knows what drug he is prescribing, what it will do and what the possible toxic reactions are, the patient obviously benefits. Let us consider next the retail pharmacist. Like the physician he finds it difficult to keep up with names that are hard to pronounce or which do not resemble the names that have been given to closely related drugs. Frequently, a physician will depend upon a retail pharmacist to give him information on a new drug with which the

physician is not familiar. The pharmacist often gets blamed for the price the patient has to pay for a prescription because it is the pharmacist whom the patient pays. I am not an expert in the field of economics and, therefore, cannot predict what effect the proposals in the act relating to patients would have upon the price of drugs. But it appears to me that one factor contributing to the cost of distributing drugs at the retail level is the increase in the druggist's overhead made necessary because he has to store so many different drugs. Increased dissemination of information to physicians and giving similar names to closely related drugs would mean that physicians would continue to prescribe a well-known and well-tried remedy rather than changing to the newest modification because they failed to recognize that it was essentially the same drug that they had been prescribing all along; this would mean that fewer drugs would have to be stored. Consequently, there would be less overhead from carrying a variety of drugs in stock, and the retiler could save by purchasing the smaller number of drugs he did store in larger quantities. Hospitals have recognized this and have developed formularies which consist of a selected list of drugs which are considered to cover all the uses to which drugs could be put. Only these drugs are carried in stock.

Senator KEFAUVER. Before you leave the pharmacist, it is a great burden for the pharmacist to have to carry 6 or 8 or 10 trade-name products of exactly the same drug, is it not?

Dr. DOWLING. Yes.

Senator KEFAUVER. And that, of course, is overhead that is passed on to the patient necessarily. In a matter I had up in Tennessee last year, I tried to get the pharmacist to understand, and I glad that a great many of them did, that many people need these new drugs who are literally unable to buy them; that if they could sell, for instance, more antibiotics or more corticosteroids to more people, in the end they would do just as well profitwise and have a whole lot better satisfied customers, is that not true?

Dr. DOWLING. Yes.

Senator KEFAUVER. I think a lot of people do not really understand the fact that many patients need these wonder drugs that cost so much and are just literally unable to pay the price that they have to pay for them at the present time. If they could buy them generically, they could get them a whole lot cheaper.

All right, Doctor, do you want to go on?

Dr. DOWLING. What about the pharmaceutical manufacturers? I have stated before and wish to reiterate my belief that the pharmaceutical industry in this country as an industry has done a great deal for this country and for the world.

I should like to point out that the requirements for licensing, for better testing of drugs and for proper dissemination of this information cannot help but strengthen the position of the large group of manufacturers who make careful studies of the drugs they produce and attempt to disseminate complete and honest information about them. Any companies that might have been attempting to get by and to shade the truth a little will either have to change their methods or go bankrupt. It seems to me that they and only they should be objecting to the proposed legislation as it pertains to the determination of efficacy, and the licensing of pharmaceutical producers.

In summary, I believe, first, that the Secretary of Health, Education, and Welfare should approve of the claims for efficacy of a drug for the purpose claimed by the manufacturer.

I believe that this will benefit the patient, the physician, the retail pharmacist and the pharmaceutical industry.

I believe that this will strengthen the hand of those groups that are trying to give prompt and accurate information to physicians regarding new drugs such as the Council on Drugs of the AMA.

I recommend that the bill states that the Secretary is not approving the use of drugs in the practice of medicine, but merely the claims made for these drugs; that he is not necessarily approving a drug for use in a specific disease; and that he is not deciding upon the relative efficacy of drugs.

I recommend, also, that provision be made that panels of experts be consulted by the Secretary before important disclosures are made with regard to the efficacy.

This should be: before important decisions are made with regard to efficacy of drugs.

Second, I believe that in this area where a mistake may mean death, that identification is extremely important. To this end, I believe that the official name of the drug should be used as prominently as any other name, and that this name be as easy to remember and as meaningful as possible.

For this purpose I believe that the Secretary should be authorized to recognize as official the names adopted by the conjoint committee of the USP and the AMA unless he believes that another name would be simpler or more meaningful. If so, he would designate that name instead.

Third, I believe that every reasonable means should be used to convey important information about drugs to physicians and others who use them. The distribution of the package information to physicians and the provisions with regard to advertisements would help accomplish this. They would be complemented and amplified by informational programs such as that contemplated by the AMA.

Senator KEFAUVER. Dr. Dowling, this is a very thoughtful and helpful statement that you have given us. It is lucid and concise, based upon a great deal of practical experience as to the Food and Drug Administration, by virtue of your study of the Food and Drug Administration, based upon a great deal of information as to the effect this bill would have on the physician, the patient, the retail druggist, the pharmacist, and the pharmaceutical manufacturer.

We are very grateful to you for the time you have taken to come and testify and give us your views.

Are there any questions of Dr. Dowling before he leaves?

Mr. CHUMBRIS. I would just want to ask one further question of Commissioner Larrick on a point that I raised a moment ago.

Commissioner, of the new drugs that you test for safety and also on which you cannot separate efficacy, how many times have you determined that there was no efficacy but the drug company insisted on putting the drug on the market?

Mr. LARRICK. I cannot give you a number, but there have been some drugs that we thought were completely innocuous and also worthless but since we could not show harm, we had to make the application effective.

And, simultaneously, we would write them a letter and tell them that we thought it was no good, but then it might take us several years to gather the necessary clinical work and to prove our opinion that it was ineffective to a court and to a jury.

Mr. CHUMBRIS. What percentage would you say, without specific numbers? Would it be 5 percent, 2 percent?

Mr. LARRICK. No, it would be far less than that.

Mr. CHUMBRIS. Less than 2 percent?

Mr. LARRICK. I would think so.

Mr. CHUMBRIS. Of the number of new drug applications?

Mr. LARRICK. Yes, I would think so.

Now, there are many cases where there could be an argument about its therapeutic value. We do not think that the drug is as valuable as the firm claims it to be, but we are not in a position to disprove their claim.

Mr. CHUMBRIS. Then over 98 percent would be both safe and efficacious?

Mr. LARRICK. But not necessarily to fulfill the broad sweep of their claims.

Senator KEFAUVER. The committee is honored to have with it again a very distinguished physician, Dr. Maxwell Finland of Boston. Dr. Finland testified previously before this committee on September 12, 1960. His testimony is at page 13923.

At that time Dr. Finland was testifying in connection with antibiotices of which he is one of the world's leading authorities. Dr. Finland's biography was presented when he testified here before, but in summary, he received his M.D. at Harvard in 1926; interned at Boston City Hospital; was associate professor at Harvard; associate director of the Thorndike Memorial Laboratory; physician in chief of the fourth medical service, Boston City Hospital; and he is also associate professor of medicine at Harvard Medical School.

As of right now, there has been objection to our sitting because the Senate is in session. I will have to declare a short recess and hope nobody will leave, and we will see if we can get it straightened out. Then Senator Hart will preside and I will be here as much as possible. We will have a 5-minute recess.

(At this point a short recess was taken, after which the hearing was continued.)

(Present at this point: Senators Kefauver (chairman), and Hart (presiding).)

Senator HART. The committee will be in order.

The objection to our sitting during the period the Senate is sitting has been withdrawn.

Therefore, Doctor, the chairman, Senator Kefauver, having already introduced you, I hope you will understand the reason for our delay. Unless you have some preliminary observations you would like to make, we would welcome your reading the statement that you have prepared.

73753-61-pt. 1--28

STATEMENT OF DR. MAXWELL FINLAND, ASSOCIATE PROFESSOR

OF MEDICINE, HARVARD MEDICAL SCHOOL

Dr. FINLAND. I would like to make one or two observations.

First of all, I had to prepare this rather rapidly in order to get it in here in time to have it duplicated. I have made some small changes that I shall be glad to stop and indicate.

Secondly, I think it would probably be better if you agree that I read the entire statement through and then answer questions. This would give everybody an opportunity to hear my views and then cross-examine.

Senator HART. The committee will respect your suggestions. We will defer any comment, if that is agreeable with Senator Kefauver. Senator KEFAUVER. That is fine.

Senator HART. Until the conclusion of the reading.
Dr. FINLAND. Thank you, sir.

Mr. Chairman and members of the committee, my name is Maxwell Finland. I am a full-time physician at the Boston City Hospital where I hold the title of physician in chief of the fourth medical service and associate director of the Thorndike Memorial Laboratory. These are units of the hospital for patient care, teaching, and clinical investigation; they are part of the Department of Medicine of the Harvard Medical School where I hold the title of associate professor of medicine. My particular investigative interests throughout nearly all of my professional career have been in the field of infectious diseases and their management. Since the introduction of antimicrobial drugs and antibiotics, most of my investigative activities have been concerned with the study and use of these agents.

As a physician I am concerned with acquiring information about the best and most up-to-date methods, including antibiotics and drugs, for use in the best interest of patients. As a teacher it is my duty to transmit such information to students and to other physicians, and to instruct them in their application for the benefit of their patients. As an investigator I have been concerned with determining the activity and evaluating the efficacy of new therapeutic agents and the optimum methods of employing them to increase the scope and effectiveness of the treatment of patients.

Last September, I appeared before this committee at your request and expressed my convictions, which I think are shared by most authorities in the field, at least in this country, concerning the use of antibiotics in fixed combinations. I also presented some personal views concerning the evaluation of new drugs and offered suggestions of some mechanisms whereby unbiased and reliable evaluations might be made of data presented to support claims of efficacy and safety of drugs and whereby the most reliable data could be gathered that would be useful to assist the FDA in its decisions on new drug applications. My present appearance before this committee is again in response to your request and invitation to present my views and comments on possible medical implications of some of the provisions of Senate bill S. 1552, which deals with the manufacture and distribution of drugs intended for prescription by physicians.

I would like to preface my comments on the provisions of the bill in question with a few general remarks which may serve as background