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grams to occupy a lot of loose time that has developed for our youngsters in both high school and college.

The dangers of LSD are great and certainly we do not want to minimize them. Perhaps the evidence is not absolute but from things we have seen it is quite likely that future generations might be affected by the use of LSD, having deformed youngsters. In fact, one physician testified as to abnormalities of fetuses in cases of miscarriage, that these were actually seen.

Of course, we have not known the drug long enough, as I would see it, to reject it. We cannot yet figure into the second and third generations because we have not known it that long.

Again, there is one little question I would like to ask and that is suppose you have a youngster who has one tablet or 250 micrograms-I believe that is the dose of LSD, is it not?

Dr. YOLLES. 100 or 200 micrograms.

Mr. CARTER. 100 to 250 micrograms-suppose you have a high school student who has one tablet which has been given to him. Would you think it would be wise for the law to be so worded that that youngster, upon disclosure of his source, could be freed upon disclosure? Would you agree to that with that disclosure clause in the law?

Dr. YOLLES. I could only have a personal position. I am told by the Justice Department that this is a very important reason for the possession clause, the penalty for possession in the law. Not having tried to enforce any of these laws, I really have no personal experience on which to base an opinion.

Mr. CARTER. Certainly I think that would be wise. After all, there are so many of these youngsters and, as you say, we could do irreparable harm to them in keeping them from going to their physicians if they develop nervous or psychoneurotic or psychopathic disorders.

Thank you very kindly.

Mr. ROGERS. Dr. Yolles, do we know at what microgram level the hallucinations begin?

Dr. YOLLES. The usual dosage has been somewhere between 100 micrograms and 250 micrograms. It depends on the individual concerned. As with most of the hallucinogenic drugs, there are a number of factors which go into the effect on the individual. One is the amount and the quality of the substance ingested. The second is the expectation of the individual. The third is the environment in which the drug is taken.

Mr. ROGERS. What is the least amount that your experiments show they have obtained hallucinations?

Dr. MEYER. You have increased perception and what could be called hallucinations at 50 micrograms, but the so-called psychedelic experience which is desired by the user usually begins at about 100 micrograms.

Mr. ROGERS. What is the normal amount used? Is it from 100 to 600 micrograms?

Dr. MEYER. In terms of the attempted therapeutic uses, it is 100 to 250 micrograms.

In terms of the street, Dr. Alpert says he has used as much as 1,000 micrograms and over an extended period of time. I suspect that this amount has been used on the street.

Mr. ROGERS. Do you build up a tolerance?

Dr. YOLLES. Yes, very quickly.

Mr. ROGERS. So you would have to take more and more to get an effect?

Dr. MEYER. Yes, it is an acute tolerance. Over a period of a few days it disappears. It is quite different from the tolerance to heroin which lasts much longer.

Mr. ROGERS. IS LSD an approved drug at present?

Dr. YOLLES. No, it is not. In the sense that an investigational new drug permit has to be acquired for anyone who is going to use it. This is the purpose of the committee that has been established by the FDA and the NIMH.

Mr. ROGERS. In other words, a doctor just cannot prescribe this now? Dr. YOLLES. That is right.

Mr. ROGERS. So there is no approved medical use of this presently? Dr. YOLLES. No, there is no approved

Mr. CARTER. Would the gentleman yield?

Mr. ROGERS. Would you just permit him to answer the question. Dr. YOLLES. There is no approved use without certain controls on use of the drug. There are experimental and research uses for the drug at the present time.

Mr. CARTER. Was it not a component part of the product manufactured by Sandoz ?

Dr. YOLLES. A related chemical constituent but not LSD per se. Mr. CARTER. d-Lysergic acid is part of Sanserd?

Dr. YOLLES. It is a part of it, yes,

Mr. CARTER. That is so closely related. I knew that was a component part of Sanserd and it was prescribed and used at one time by physicians in the United States.

Mr. ROGERS. Was it approved by the Food and Drug Administration?

Dr. MEYER. Sansert was approved by the Food and Drug Administration with the appropriate warnings that in the therapeutic uses, there may be psychological and neurological difficulties.

Mr. ROGERS. But LSD has not been approved except for experimental purposes at present which is controlled and it is done through NIMH?

Dr. YOLLES. It is a joint endeavor of NIMH and the Food and Drug Administration. Food and Drug controls it and we supply it.

Mr. ROGERS. I have a copy of a book entitled, "LSD, Man and Society," edited by Richard D. DeBold and Russell C. Leaf. One of the statements in the book is this:

Thus, the researcher faces major hurdles in getting the drug to begin with, even if he has financial support from some other source, and an even more difficult task if he wishes to get both the drug and financial support from the National Institute of Mental Health. Once he has secured financial support and the drug, he faces yet a third hurdle-the Food and Drug Administration. Since LSD is not yet an approved drug, the prospective researcher must file an investigational new drug application (IND) with the Food and Drug Administration. This is a rigorous procedure and added to the rigorous procedure of securing the drug and financial support from the NIMH, it becomes an almost impossible task to actually commence research with LSD. Milton H. Joffee, of the Bureau of Drug Abuse Control of the Food and Drug Administration, has already stated, "the use of these drugs in research is reasonably plain, although I must admit that certain administrative procedures and coordination between FDA and NIMH have not been reduced to the smoothest operation in the world." There

is a great deal of truth in the accusation that meaningful research with LSD has been greatly retarded by the failure of coordination by those two controlling agencies.

What would be your comment on that, Dr. Yolles?

Dr. YOLLES. I am a prejudiced observer but I will try to be as objective as possible. We are presently supporting research on LSD at the level of $3.4 million, an increase of $1.7 million. Despite its high priority, there has been no shortage of funds in this high-priority area.

First of all, the LSD was taken over from Sandoz by the National Institute of Mental Health which is normally not a distributing agency for the principal purpose of protecting the research endeavor in the United States, so that it could go on and so that LSD would be available for researchers.

Secondly, in order to expedite and coordinate the activities of two Federal agencies, in one case the NIMH and, secondly, the FDA, we organized a joint committee to recommend by one decision to both agencies for the awarding of an IND drug permit as well as release of the drug.

As far as getting funds from the National Institute of Mental Health, overall I would say that we approve or the National Advisory Mental Health Council approves somewhere on the order of 40 percent of all applications.

I would like to point out that we hope that we could support all approvable research that comes in. However, it is not always the financial constraints that keep us from supporting the research. Some research is just not supportable because it is not worth supporting. There were a number of investigators who the committee felt had presented research which just could not be supported on a scientific basis.

Mr. ROGERS. Do you put a limitation on the amount of drugs that can be given to a person in research; for instance, in the micrograms? Is there a limitation placed on the researcher, or do you allow him to go to 100 or 150?

Dr. MEYER. A detailed protocol has to be submitted for the number of subjects and the amounts of LSD to be administered. The committee reviews the protocols for human studies very carefully so there are limitations on the amount of LSD that is administered.

Additionally, I might say that the committee has been really quite responsive to the demand for LSD; 93 studies are being currently made, as Dr. Yolles pointed out, and approximatley 114 requests for LSD were received. Of those that were turned down, many of them were from high school students for science projects; most reputable physicians and psychologists received drugs where adequate protocols were submitted.

Mr. ROGERS. Some of the criticism I have heard is, for instance, an investigator is not allowed to give a dose to the person who may come to him to participate, and I understand they often get people who are taking the drugs to participate that are now on drugs-there is too much of a limitation on him and he really does not have very much discretion in the amount of dosage, that it is reduced before it is approved. In other words, 50 micrograms rather than letting him have 100 or 200 for use at his discreption.

Dr. MEYER. Are you referring to a specific study that is being done? Mr. ROGERS. I do not know where the study is being done.

Dr. MEYER. The investigator has to receive permission, of course, of the institution where he is doing the research.

In terms of a limitation at 50 micrograms, I know of only one study that had this limitation.

Mr. ROGERS. There is one that has that limitation.

Dr. MEYER. That was in the protocol they submitted to limit the dose to 50 micrograms to people who had experienced greater dosages in the street. That was at their discretion.

Mr. ROGERS. Do you have investigations going on by volunteers, people who never took the drugs who have volunteered?

Dr. MEYER. There was a study recently terminated at Patuxent Prison in Maryland under the auspices of the Psychopharmacology Branch where prisoners who had not experienced the drug had been given the drug and the reaction was recorded.

Mr. ROGERS. How many persons were involved in that, do you recall? Dr. MEYER. AS I recall there were 30 prisoners involved in the study. Mr. ROGERS. I would like to see some examples for the record of how many people are involved in all of your research projects.

Dr. MEYER. Again, I would have to submit this information for the record.

(The following information was received by the committee:)

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Mr. ROGERS. Could you give us any rough idea now?

Dr. MEYER. I would hesitate to do that but I will furnish that information to you.

Mr. ROGERS. I have one or two other questions.

Do you think our educational and informational projects are effective now?

Dr. YOLLES. As I said before, I think that in large measure the reduction in LSD use in the United States is a reflection of the kind of information that was gotten out through such educational projects. One of the large ones involves the colleges, the deans of colleges and student personnel administrators in a large-scale project to educate not only the faculties of the universities and colleges but also the students. We hope to expand this effort considerably during this coming

year.

Mr. ROGERS. What have they done in that project? You say educate the students. How do you do that?

Dr. MILLER. This started with education of the personnel administrators. Courses were held primarily to educate them.

Mr. ROGERS. Do you just have a conference and tell them of the dangers and let them go back to the school? How long does it last?

91-872-68-13

Dr. MILLER. They were 2-day conferences. There was opportunity not only for presentation of papers but also opportunity for discussion which is very critical to this. These persons then returned to their campuses and continued and expanded their previous activities in terms of educating their students.

Mr. ROGERS. What would they do?

Dr. MILLER. They would have seminars and meetings with key student leaders to instruct them on what they had learned about the dangers related to LSD and other dangerous drug use.

Mr. ROGERS. Is there any way of knowing whether that got through to the student body or not or does it just go to the few student leaders? Dr. MILLER. It is extremely difficult to evaluate the effects of an educational campaign.

I would agree with Dr. Yolles that the reported dropoff in use of LSD is some index of the efficacy.

In terms of a firm, scientific relationship between an educational campaign and drug use, we currently are considering some proposals which would try to measure this. It is an extremely difficult thing to do from a research standpoint, but we are trying to develop some techniques to measure use before and after to see if it is related to an educational type campaign.

Mr. ROGERS. It seems to me a very quick way of getting a student population to enlist the American Medical Association. It does not cost much, the doctors generally are willing to give of their time, and if you prepared the necessary basic material for them, this could be done in this Nation within a 2-month period of time. It is being done, I know, in one of my counties and it is being well received by the students, and the doctors go in with the scientific facts, like you say, not an emotional appeal or trying to moralize but simply here are the facts, and I dare say they probably take it as well from a doctor who is giving a very unemotional speech and says, "Here is what science has found and here are the results," rather than having a speech from some teacher whom they might question whether this teacher really has the competency to know.

I wonder why your program where you have an educational program has not enlisted this sort of help on a crash program basis very quickly. Could this not be done?

Dr. YOLLES. Yes, sir. As a matter of fact, it is being done at the present time. Right now, we are enlisting the aid of a number of medical societies. We hope to have this spread across the entire United States.

Mr. ROGERS. I talked to the president of the American Medical Association and he seemed very receptive, and I would hope you could follow up on this and see if we couldn't get this initiated throughout the Nation. I think it could be done very quickly, and I think it could be very helpful.

Thank you for being here and giving the committee the benefit of your thoughts.

Our next witness is Dr. Randolph Edwards, professor, Department of Health, Physical Education, and Recreation, College of Education, Temple University, Philadelphia, Pa.

Dr. Edwards, we are very pleased to have you here and we appreciate your making yourself available to the committee to give us the benefit of your experience and knowledge in this field.

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