Senator HRUSKA. Well, now, wait a minute. That is where we get into difficulty, because the panel of experts functioning under this law and to administer this law cannot go beyond the law.

That is the point that we have been trying to make here day in and day out on many weeks on end. They cannot go beyond this.

If they do, that would be the same as a judge saying:

"This is a very bad case. The man did not break any law, but he is a wicked man, so I will say, well, I will punish him anyway." You see, you cannot do that in the field of the law. That is the point we are trying to determine here.

Dr. GOODMAN. You will notice in my prepared statement, Senator, that over and over again I said proof of claims, of submitted claims of drug efficacy. If the law does not state that, I think it should. Senator HRUSKA. It does not say that, but

Dr. GOODMAN. Otherwise, we are going to get into the same problem as you have just indicated: What do you mean by "efficacy." Senator HRUSKA. What it says here is:

Whether or not the drug is safe for use and is efficacious in use under the conditions prescribed.

Now, that is pretty close to saying "under claims made." But suppose the claim is made that drug A will relieve pain, and, by golly, it does. Maybe it does not do as much as aspirin or Bufferin, but it will relieve pain. The purpose of that question is simply this: That if it will meet the requirement of this law and a license must be granted, then the law is quite meaningless.

Dr. GOODMAN. I think it would be a very peculiar pharmaceutical company that would present that type of claim to the Food and Drug Administration.

Senator HRUSKA. Exactly.

Dr. GOODMAN. They would be cutting their throats. They are all much more knowledgeable than that.

Senator HRUSKA. Exactly.

And, you see, Doctor, that is the point of some of us who say: "Let us not freeze this into law because for any pharmaceutical company to make something that is useless is unthinkable"; that does not follow, do you not see, the same way that you have mentioned it right now?

That is some of the argument that we are making to show that this law would only cast in the way of the development of medical science and pharmaceutical science certain handicaps and hindrances and obstacles to proper development of drugs.

Dr. GOODMAN. Well, we do not see eye to eye at all, Senator.

I still maintain that the better law would be one under which the Food and Drug Administration, through committees of experts in various therapeutic areas, makes the decision whether the discrete and detailed claims of pharmaceutical manufacturers for their drugs being recommended for specific therapeutic uses are, indeed, valid.

And you say, "Let the Food and Drug Administration operate as it does; don't freeze it into law; talk only about safety."

And I claim, sir, that you cannot make any valid statement, any meaningful statement, about safety without taking recommended use, conditions of use, into consideration-and this immediately gets you into the area of therapeutic claims.

What you are saying is that a company could present the Food and Drug Administration with a perfectly harmless chemical; even the most rigid determination of toxicity in animals and man would show that it is harmless. Then they could go on, if they were stupid enough to do so, and claim it was useful in the treatment of cancer. Here is a harmless drug. By law it has to be approved, and no one can pass on claims for it.

Medical literature will eventually hammer it down, but maybe the company will have a headstart in its advertising program. I do not say industry would do it; but if you are talking about exact meanings of the law and how it is going to operate under certain circumstances, I might have to answer you in this way, Senator.

Senator HRUSKA. Of course, that is taken care of by labeling, is it not, Doctor, and we have laws on that already. You cannot say in the label that this is good for cancer when it is not.

Dr. GOODMAN. You might say that some people have recommended it is good for cancer. You can always find a few doctors that might say this. We have such a case before the government in the State of Illinois right now, where you will find that a score or more of doctors, including one of our most prominent medical scientists, have gone overboard for a compound which is recommended for the treatment of cancer. All you would have to state in your label is: "Some of our leading medical scientists claim this drug is good for cancer." They would be telling the truth in the label. Who is going to stop them now? The drug is safe. It is nothing but paraffin oil.

Senator KEFAUVER. Nothing but what?

Dr. GOODMAN. The last analysis I saw was paraffin oil. I am talking about Krebiozen. It is now also meant to contain something obtained from horse serum.

Senator HRUSKA. Of course, Doctor, that would be covered by our present statutory provisions which are under the category of misbranding, so there are some statutory provisions now bearing on that subject.

Dr. GOODMAN. Sir, how is it misbranded, if all they say on the label is that leading medical authorities they can even give the names. I see no reason why they cannot put that on the label-truly believe that this drug is useful in the treatment of cancer? How is the present law to stop it?

Senator HRUSKA. If there are companies that will do that, Doctor, you cannot laugh off companies that will come within the law by simply showing that a given drug will relieve pain even if that relief of pain is one degree.

You see, you kiss that one off. You said that will never happen, and yet you tell me that there are companies that will have drugs that are perfectly worthless; they do not even go one degree toward the claim. I come back to that proposition. Suppose there is a fulfillment of the claim that gives only one degree of relief from pain. Would the company be entitled, under this law, to a license to produce that drug?

Dr. GOODMAN. I do not know what one degree, as to relief of pain, is on a yardstick of meausrement of pain. It is really not that precise. If you mean that 1 patient out of 100, with a certain type of measureable pain, is relieved-if that is what you mean-then we get into the problem of controlled studies and placebos. I can do better than

that. I can give milk sugar and 35 percent of people will be relieved of pain.

Senator HRUSKA. But you cannot use that in the law, just because you can do it better with something else; that will not entitle the Department of Health, Education, and Welfare to deny the license to produce that drug, if it will do what they claim it will do.

You see, you cannot go in there and say: "Mr. Panel, this is no good because, while it does relieve pain, I can do better with a tablespoon of salt in some water."

You see, that would not be any argument.

Dr. GOODMAN. I could make a fortune and support our entire medical center if I could market placebos, and that is why we have controlled studies. Pharmaceutical companies are geared with the very best laboratories and scientists to conduct controlled studies.

Senator HRUSKA. If we were legislating only for companies which are upright and which are in good faith, which are trying to do the right thing and which want to keep within the spirit of what the panel wants, that would be one thing, but, unfortunately, we are not.

When a shield like this, instead of becoming a shield for the patient to be protected against something, becomes in the hands of the unscrupulous or the unethical manufacturer a spear, then we get into trouble, and I do not want to be a party to anything that puts a spear in the hands of that kind of a fellow.

Thank you very much, Doctor.

Senator KEFAUVER. Ás matters now stand, there is no requirement under the bill for proof as to claims of efficacy, so that your example of 1 percent or your placebos perhaps could be put on the market.

Under the bill there would at least have to be a passing on the claim of efficacy by the Food and Drug Administration that it was not just innocuous, that it had to have some value. You said you could make a fortune, if you were that kind of a person, out of marketing placebo tablets, did you not, Doctor?

Dr. GOODMAN. It has been done with some drugs that are already on the market, sir, some drugs described in this book ("New NonOfficial Drugs, 1961"). They are no better than placebos. In one case, an expert consultant wrote in to our council on drugs and said:

If you must describe this drug, make the last sentence in bold print read, as follows: "Placebo, expensive."

Senator KEFAUVER. Placebo what?

Dr. GOODMAN. Expensive. But you will not see such statements in this book. And that is why I say to you, Senator Hruska, I do not want to go on record as agreeing with you about the seal program. I have said in this regard, on two or three occasions in this document, that I think the seal program under the AMA was one of the finest things they ever did, and I regret it was dropped, and I do not know the reasons why it was dropped. They should have expanded the educational program, to be sure, but their seal program should have been retained.

Then, if they felt that they had to describe other drugs that did not come under the seal program, they should have devised other educational methods. I want to tell you that the teaching of pharmacology and the writing of textbooks in this country are made extremely difficult, because in the old days we used to tell our stu

dents: "Now, when you open your office and the drug salesmen are waiting outside with their high school or 2 years of college education to tell you all about pharmacology, you just say: 'Is your product accepted by the Council on Pharmacy and Chemistry of the AMA for their seal of acceptance?' If he says no, you tell him you are not interested, to come back when it is."

Now, he may come back and say, "Doctor, my compound is now accepted"; and then say to him, "Don't bother me. I can read all about it in this (council) book, at my leisure."

We cannot do that any more.

And I want to tell you one other thing. When it comes to describing 20, 30, or 40 antihistaminics in a textbook or in a lecture, how in the world do you do it? In the old days we did it this way. We took one prototype, the real one, or two or three breakthroughs in the field, and described them fully. Then we told the students:

"Look, there are other drugs that are not as good as these original drugs, but each one has some slight difference in toxicity or occasional value in an allergic patient," and so forth. "You use these as backup drugs."

Then the student would say: "Where do I learn about them?"

We would say: "Only use those drugs after you have studied about them and the place to study about them, if they are not in the textbooks, is in the seal of acceptance program of the AMA."

We cannot do that any more because the council now describes almost everything in its yearbook.

Senator HRUSKA. Of course, I come back to another thing that I said at the outset, and that is that you are for a seal program and so am I, provided it is a good and effective seal program. Then, of course, the AMA said they could not put enough money into it to make that a good and effective program, so they had to abandon it.

Dr. GOODMAN. The seal program, sir, was not kind to advertising. If you look through the issues of the Journal of the American Medical Association up to the time the seal program was abandoned, you will find very few ads, and most of the ads for drugs, the advertising material, carried the seal of acceptance stamp.

Now, you see an enormous number, page after page after page, of ads. That may be one of the reasons. But the AMA could have kept the seal program and revised its advertising standards to say: "We will accept advertising of drugs that are not seal accepted, but only those that have our seal can stamp their advertising material with that seal." This would have been an enormous help.

Senator HRUSKA. They had to give it up and so did the physician's council. I suppose they had their reasons for doing it.

Thank you.

Senator KEFAUVER. Dr. Goodman, you were holding up a book a minute ago and you said many drugs listed in that book were no more than placebos.

For the record, the book you were holding up was the 1961 edition of New and Nonofficial Drugs?

Dr. GOODMAN. That is correct. I am sorry to say that I had to pass on some of these monographs, but that is the way we operate. Senator KEFAUVER. The book is put out by the American Medical Association's Council on Drugs.

The drugs listed there, some of which are no better than placebos, are not toxic, but the Food and Drug Administration had no alternative but to approve them, even though they are not efficacious?

Dr. GOODMAN. May I make one comment about a placebo not being toxic. The human mind and body are so constructed that, if you give a placebo to 100 people, 35 will have toxic effects from a placebo (milk sugar), such as headache, nausea, vomiting, diarrhea, even rash or rapid heart rate. All sorts of things happen when a person swallows a chemical, even though it is harmless and inert.

Senator KEFAUVER. That is the reason you think there should be relevancy to the claims of efficacy?

Dr. GOODMAN. That is why experts talk in detail about controlled clinical experiments; that is why the individual practicing doctor cannot be the judge.

Senator Hruska, when you were talking to Dr. May, saying he is deprived of the privilege of using a drug in his patient unless he does it just as a pure investigational program and tells the patient: "I can't sell you this drug; no one can sell it to you; I have to use it as an experimental drug, but I think it is going to do you some good," how is the doctor prepared to judge whether any beneficial effect is merely caused by his influence, that is, the halo and psychological effect of the doctor-patient relationship? He can do as much by laying on hands. How do you think chiropractors and others are so successful?

Senator HRUSKA. Yet, it will ultimately depend on the physician himself, even with that before him?

Dr. GOODMAN. Yes, but there has to be some cutoff point. There has to be some basic, original, clinical evidence that this drug is a useful drug and that the claims made by the manufacturer are valid. Senator KEFAUVER. Dr. Goodman, it is too bad that we Senators are not doctors, so that we could understand you better.

Dr. GOODMAN. It is too bad we doctors are not lawyers so we could understand you better.

Senator KEFAUVER. Sir, I think everyone who reads this record will be grateful to you for your advice and counsel and your suggestions, which all of us have found most helpful. We are grateful to you for coming here.

Dr. GOODMAN. Thank you, sir, and I appreciate that you missed your lunch. Maybe this will keep your blood cholesterol down. (A letter subsequently received from Dr. Goodman may be found on p. 971.)

Senator KEFAUVER. Before we recess, a letter to Senator Dirksen from Congressman Clark MacGregor, enclosing a letter to Congressman MacGregor from Mr. W. B. Reynolds of General Mills, will be placed in the record. This will be exhibit 36.

(Exhibit 36 may be found on p. 807.)

Senator KEFAUVER. We have a communication from the American Public Health Association of July 14 with a request that it be put in the record. It will be exhibit 37.

(Exhibit 37 may be found on p. 810.)

Senator KEFAUVER. The committee will stand in recess until 10 o'clock tomorrow.

(Whereupon, at 2:30 p.m., the hearing was adjourned, to reconvene at 10 a.m., Wednesday, July 19, 1961.)