Mr. RANKIN. This is a compound, Congressman, which was used in very large quantities, much larger than prescribed, by some people who developed kidney difficulties. As a result of that, we have required the labeling of products containing phenacetin to bear a warning against exceeding the recommended dosage.

Mr. FLOOD. Like the story of the Irishman who got a bottle which said take 1 spoonful every 3 hours and who figured, "What the hell! If 1 spoonful will help, I will take the whole bottle." So he did, but he died.

Dr. GODDARD. This is one of the problems in evaluating new overthe-counter preparations.

Mr. FOGARTY. Is this one of the drugs that was talked about in the Fountain committee hearings?

Mr. RANKIN. No.

Mr. DUNCAN. Your veterinary medicine is important not only to the health of the animal but the health of human beings as well. Dr. GODDARD. Yes; this is correct.

EXPERIMENTS WITH PARATHION

Mr. DUNCAN. I am interested on page 29 that you are feeding people parathion.

Dr. GODDARD. Yes; volunteer studies.

Mr. DUNCAN. Who would volunteer to eat that?

Mr. SPARER. These are prisoners. They get time off for their contribution, apparently.

Mr. DUNCAN. Is that a nerve gas?

Dr. GODDARD. It is not a nerve gas. It does work on the cholinesterase system of the human body which is involved in transmission of impulses. Maybe the nerve gases do interrupt transmission of impulses along the nerve paths by changing the enzyme activity.

Mr. DUNCAN. It is a highly toxic product. I had a lawsuit one time involving tetraethyl pyrophosphate, which is a related thing, is it not?

Dr. GODDARD. Yes.

Mr. DUNCAN. Just a drop or two on a man's hand of a highly diluted solution was enough to kill him, paralyze him, but you are feeding them that stuff?

Dr. GODDARD. These programs are being carried out in such a way that I can assure you there is no danger to the volunteers. The amounts being given are very well within the toxic range.

Mr. CARDWELL. Prior to the human studies in this case, there were studies with both lower animals and primates, and they moved gradually to human beings.

Mr. DUNCAN. Does not the body hold that parathion?

Mr. CARDWELL. This is one of the things that there is an attempt to determine without human experimentation. That is the reason never find the answer.

Mr. RANKIN. The product does not accumulate in the body.

Mr. DUNCAN. Parathion does not?

Mr. RANKIN. It does not accumulate.

Mr. DUNCAN. I thought you had evidence that it did.

Mr. RANKIN. No, sir; I am not aware of that.

(This further clarification was submitted for the record:)

ASSIMILATION OF THE PESTICIDE PARATHION IN THE HUMAN BODY

Unlike such pesticides as DDT and dieldrin, which tend to build up in the body fats, the pesticide parathion is assimilated relatively quickly and does not accumulate in the body.

HALLUCINOGENIC DRUGS

Mr. DUNCAN. Are the hallucinogenic drugs within that Drug Control Act that we passed?

Dr. GODDARD. Yes; they are one of the three categories in the Drug Abuse Control Act.

Mr. DUNCAN. As of right now, you have to get some regulations out. When are you going to get the regulations out?

Mr. RANKIN. Several regulations have already issued on these. As a matter of fact, the regulation on LSD-25, one of the most widely talked about hallucinogencis, has already been issued. We have regulations or proposed regulations that were issued on September 17, December 18, December 29, January 8, January 18, and finally just a few days ago, January 27.

Mr. DUNCAN. So, there are some regulations out on them already? Mr. RANKIN. Yes, sir.

INVESTIGATIONAL NEW DRUG

Mr. DUNCAN. When an application for clinical use of a new drug is filed with you people, is that what you call an IND?

Dr. GODDARD. Yes; investigational new drug, for clinical testing. I should amend that to make certain we are talking about the same thing.

Mr. DUNCAN. That is what I meant. Can these drugs be used while you are working through this backlog of applications?

Dr. GODDARD. When the manufacturer submits an IND, unless he hears from us within 60 days with respect to our comments on his protocol, how he is going to handle the problem, he assumes and legally assumes that we have approved his application. He can begin testing when he first submits the IND, however.

Mr. DUNCAN. If he does, it is at his risk within the 60 days?

Dr. GODDARD. We have that period of time in which to advise him. Mr. DUNCAN. With a backlog such as you have, how can you give an answer within 60 days?

Dr. GODDARD. We do this by quickly reviewing each one as it comes in. This is not a detailed, in-depth review, but, rather, to hit all the high spots on the application.

Mr. DUNCAN. The backlog does not mean there are 1,467 drugs being held up from any experimentation at all?

Dr. GODDARD. Not from experimentation, no.

KREBIOZEN

Mr. DUNCAN. We recently had a decision out in Chicago involving a substance known as Krebiozen. Did you ever hear of it?

Dr. GODDARD. Yes, sir.

Mr. DUNCAN. Have you ever tested it out?

Dr. GODDARD. In the sense that this compound was analyzed in the laboratories of the Food and Drug Administration, and also at

60-627-66-pt. 2-3

the same time by competent individuals from the universities, the scientific community, and its composition determined, yes, we have tested this compound, this so-called drug. At one time it did contain creatin, mineral oil, and alcohol. However, at other stages, it consisted of nothing more than mineral oil.

Mr. DUNCAN. The samples have not been consistent?

Dr. GODDARD. No.

Mr. DUNCAN. I thought the problem was you never could get any samples.

Dr. GODDARD. We did obtain samples.

Mr. FOGARTY. You could not in the beginning.

Dr. GODDARD. After proceedings were initiated by the agency and investigation was undertaken.

Mr. DUNCAN. Has anybody ever checked to see whether mineral oil and creatin has any effect on cancer?

Dr. GODDARD. Yes. There have been some very acid tests of this compound; namely, the patients treated by the promoters of krebiozen. They selected case histories and submitted these, and each of these was reviewed and the patients were followed up to determine whether the drug had any value. This was done by the National Cancer Institute, as I recall. It was their considered judgment, and also the judgment of their consultants in the scientific community, that it did not have any value.

Mr. DUNCAN. Why are you so confident if you have never had a test?

Mr. FOGARTY. The answer to that is that you never had a test, because on seven or eight occasions the National Cancer Institute has made provisions for tests with Dr. Ivy and the Durovic brothers, and on each occasion Dr. Ivy broke off the negotiations and refused to go through with the test unless he ran it. They have had a good evaluation. I think the last time they said we will take the 500 best cases you have, 500. They went through the 500 and came up with nothing. In my opinion, this is a cruel hoax on the American people.

Mr. DUNCAN. It may very well be. I do not know. It would seem to me with the notoriety which this product has achieved and with the interest that it has engendered, it would behoove somebody to lay the thing to rest one way or the other.

Dr. GODDARD. We hoped we would do that.

Mr. DUNCAN. Maybe you never will be able to do it. I do not know.

Dr. GODDARD. That may be the problem, but there is no evidence today that would suggest this is anything more than mineral oil, and the indication is that its use in a patient who has cancer would be deleterious and life threatening in that the patient would not seek out proper treatment. Unless there is some overwhelming evidence that the product has changed in some magical way, I would not consider it at this time able to qualify for an IND.

NO AUTHORITY TO ISSUE CEASE AND DESIST ORDER

Mr. FLOOD. Aside from strictly a criminal prosecution, have you any authority or jurisdiction to issue a cease-and-desist order in civil court by an injunction process to stop this?

Dr. GODDARD. Not to my knowledge. I wish the attorney were here to answer that specifically. Unless it enters into interstate commerce, we are limited in that.

Mr. FLOOD. Can you refer that question to your Solicitor and at this point in the record have him comment on it.

(The requested information follows:)

INTRASTATE SHIPMENT OF KREBIOZEN

The Food and Drug Administration has no authority to issue a cease and desist order. It does have authority, in cooperation with the Department of Justice, to seek an injunction in the United States district courts to enjoin violations of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332).

Mr. FOGARTY. As far as interstate commerce is concerned, they are not allowed to ship it, but they can sell it outside the country. Mr. FLOOD. You can get it in Illinois.

Dr. GODDARD. That is correct.

Mr. FOGARTY. Some of the best cancer men I have talked to claim that just the hope of this thing working has prevented surgery in time to save the lives of people. In my opinion, they are not saving lives. They are killing people.

Mr. DUNCAN. If this is true, they are going to continue to do it at least in the State of Illinois.

Mr. FOGARTY. It was a big political thing at the University of Illinois 15 years ago, and it has been political every since. I have met with them and talked with them. I have talked with the two brothers and Dr. Ivy. I knew Dr. Ivy 20 years ago when he was with the American Cancer Society. I thought he was a very high class physician at that time.

I think there are some blindspots now. Every year for 15 years now we have had this question about krebiozen, and we have urged the Cancer Institute and the Food and Drug Administration to bend over backwards to see to it that they received a fair evaluation, and I think they have done everything they can. Every time Dr. Ivy or his associates have broken the agreement for an impartial evaluation-every time.

Dr. GODDARD. For the record, I would like also to add that those negotiations took place before there was any opportunity to know what the so-called drug consisted of.

Mr. FOGARTY. Yes, that is right.

Mr. DUNCAN. I agree. Everything I have seen on it has consisted of a series of condemnations of the other side. I have never seen any test results other than this last analysis which you or somebody made of it. Even there, I have never seen any evidence that the thing has really been tested by anybody except the promoters of it. Dr. GODDARD. You do bring to mind one further point, however. You raise the specific question whether mineral oil had any inherent value in the treatment of cancer. I must point out that it has been suggested by the scientific community that mineral oil in itself may be carcinogenic or, in effect, cause cancer.

Mr. DUNCAN. I will close with the same observation, that I think a public service would be rendered if this thing could be laid to rest. Mr. FOGARTY. How will these people go about it? Dr. Ivy insists that he be a member of the evaluation committee and that the rules for the test be just what he lays down. He will not agree on leaving It to a group of impartial investigators.

Mr. DUNCAN. I would let him come to the conference table, I think. Mr. FOGARTY. He has been to the conference table time after time. He has been to Washington I do not know how many times.

SCIENTIFIC VALUE OF TESTING MINERAL OIL

Dr. GODDARD. There is no scientific value, in my opinion, of testing mineral oil as a means of curing cancer. Secondly, such a test would be almost impossible to design because of the ethical responsibilities you bear toward patients who have cancer. I have never known of any instance in which the National Cancer Institute or other responsible agencies involved in developing and working toward the cure of cancer has refused to test a product which showed scientific merit. I think this is the goal we are all seeking.

Mr. DUNCAN. I suppose there would be no end to the work if you tested everything that anyone thought had any value.

That is all I have.

Mr. FOGARTY. Mr. Farnum.

COMMISSIONER'S INVOLVEMENT IN MANAGEMENT PROBLEMS

Mr. FARNUM. Have you had time yet to get into all the management processes?

Dr. GODDARD. Not all of them. Of course, I have looked into a number of questions of management within the agency, as you might suspect, not all of them.

THREE NEW POSITIONS TO HANDLE ADVISORY OPINIONS

Mr. FARNUM. Under "Advisory opinions" on page 47 of the justifications, you talk about the responsibility here to provide the industry with information through various methods. You say:

As industry learns more about the Food, Drug, and Cosmetic Act, it asks increasingly more difficult and technical questions.

And the time required to answer these written inquiries has risen from 1% to 2 hours per inquiry.

You ask for three professional positions. What kind of professional positions are you asking for to answer these inquiries? Are they legal counselors to interpret the act, or administrators to give them a better understanding of what they have to do or not do, or what is it?

Dr. GODDARD. These individuals involved are what we term food and drug officers, persons who have had experience for a number of years in the field and are brought in and given special training as food and drug officers.

Mr. FARNUM. What kind of questions are these, then?

Dr. GODDARD. These are largely technical questions related to the 1 manufacture of items covered by the Food and Drug Act, what kinds of tests must be carried out, these kinds of questions.

Mr. CARDWELL. Adequacy of labeling is a very frequent line of questions.

STAFF DISTRIBUTION BETWEEN HEADQUARTERS AND FIELD

Mr. FARNUM. On page 53 you propose a 12-percent increase in stablishment inspections and a 13-percent increase in sample exami