ought to be all that is necessary to stop them. In view of that, I am just asking you, having weighed your mixed feelings, what would you recommend to the committee?

Mr. FRANZONI. I would recommend, sir, that there be a clause providing for illegal possession.

Senator DANIEL. And prohibiting that and punishing those in illegal possession?

Mr. FRANZONI. Yes, sir.

Senator DANIEL. But, of course, we will keep in mind your recommendation there that there be some way in which those in legal possession, actually with prescriptions, can prove that.

Mr. FRANZONI. That is right, sir.

Senator DANIEL. Mr. Counsel, do you have any further questions? Mr. GASQUE. Mr. Franzoni, I should like to know the status of the form which doctors are supposed to execute in regard to the dispensing of narcotic drugs.

Mr. FRANZONI. Well, I have to give this to you second or third hand, sir.

My understanding is that the regulation prescribing that form has been drawn up. It was to go to the Corporation Counsel for approval, and then forwarded to the Commissioners, was returned to Mr. Dante who had prepared it with the Board of Pharmacy, for correction of typographical errors, and it did not until, I believe, either yesterdayI believe it was yesterday-actually go forward to the Acting Corporation Counsel.

So I imagine his review of it maybe will hold it up 24 hours or so, but then he will forward it on to the Commissioners.

Senator DANIEL. Are you talking about the form we went into here back in June?

Mr. FRANZONI. Yes, sir.

Senator DANIEL. The doctors are supposed to fill out when they dispensed narcotic drugs?

Mr. FRANZONI. Yes, sir.

Senator DANIEL. Do you mean to tell me that form has not been completed and is not now in use in the District?

Mr. FRANZONI. To my knowledge it is not, sir. It has not been officially promulgated.

Senator DANIEL. Well, is there any resistance on the part of the Board of Pharmacy or on the part of anyone in an official capacity against using this form?

MR. FRANZONI. Not that I know of, sir.

Senator DANIEL. There was at one time, you know, some who felt that that form was not proper and, therefore, they admitted it was delayed. Did you feel that way?

Mr. FRANZONI. No, sir; I did not have that opinion.

Senator DANIEL. Some on the Board of Pharmacy testified that they felt like it would serve no good purpose, and there had been a delay in working it out and, of course, we had before us a case where there were aggravated violations of the law in the dispensing of these drugs.

One doctor who was not required to keep any forms was involved, and I believe in court that was the reason that his case had not been carried further; is that right?

Mr. FRANZONI. That was essentially it.

Senator DANIEL. I am talking about the Freidenberg case.
Mr. FRANZONI. Yes, sir.

Senator DANIEL. Now, can you tell us, can you tell this committee, why the forms still have not been worked out so that the doctors can know what they are supposed to use in keeping their reports on prescriptions of narcotic drugs?

Mr. FRANZONI. I can only give you my belief, sir; and I believe, I do not think it is fair to me to commit somebody else on this, but I believe the delay in it has only been administrative.

Senator DANIEL. You are doing your part as president of the Board? Mr. FRANZONI. Oh, yes, sir. Our part is actually, except for a brief review later, our part was completed at the time I appeared previously. Senator DANIEL. You realize, Mr. Franzoni, that this is, a serious thing, and that there is a need for these forms, which was certainly developed in evidence before the committee; do you not?

Mr. FRANZONI. Yes, sir.

Senator DANIEL. We were told in June that the Pharmacy Board was going to go right ahead, that these forms would be in use soon. Mr. FRANZONI. That was our impression and intention also, sir. Senator DANIEL. Will you report to this committee as soon as the form has been approved and is in use by the physicians?

Mr. FRANZONI. Yes, sir.

Senator DANIEL. Do you have any estimate of the time necessary before completion?

Mr. FRANZONI. Well now, this is Tuesday-I hate to commit other people, I mean, it is out of the Board of Pharmacy's hands right at present, but I see no reason now, from the way I understand the situation, why the Commissioners might not have that before them for approval by the end of the week. Then its official promulgation would be in the District of Columbia Register, which corresponds to the Federal Register, and I believe the next-it comes out every 2 weeks, so it would be in the next following issue that that would come

out.

Senator DANIEL. I do not mean to be in a position of scolding, that is not our business but it just seems like something of this nature that is everybody's business turns out to be nobody's business, and here we go all through these years after the law required these forms without them being put into operation. Then after all the testimony before this committee in June, you come back here the last part of September, and still forms have not been set up. Do you have anyone with you today who could give us any further information as to the status of the form?

Mr. FRANZONI. There is a representative of the Corporation Counsel's Office in the room, but I do not believe that he is familiar with that particular point,

Mr. WHITE. I am C. Belden White III. I am in the Legislation Section; I knew nothing of this until just now.

Senator DANIEL. Thank you very much. We certainly thank you for your appearance here today. We got off on this form business here, and I hope that next time this committee ever asks a question on that, it will show that the record is closed on that particular matter. I want to emphasize now, going back to barbiturates, how much we appreciate the information you have given this committee on that subject, and the recommendations that you have given us with respect to the law.

Mr. FRANZONI. I might, Mr. Chairman-if I may, sir, I would like to point out one thing, following up on Captain Thoman's evidence, and that is he had mentioned the arrests of 1 or 2 or I believe he said several druggists for the sale, illegal sale, of barbiturates; and he, the way I understood him, he gave the impression that their licenses had been revoked.

Unfortunately, the Board of Pharmacy is in the position under our present law that we cannot institute revocation proceedings until such time as a man has been convicted of a criminal offense or crime involving moral turpitude.

We have no suspensory powers. We cannot suspend the license. We either have to revoke or reinstate, and so we have been-and we have a regular procedure set up.

As the police department reports these offenders to us, we turn it over to our Investigations Division. They, in turn, follow up on the police trial and the results of that, and then schedule it or advise us to when a hearing may be scheduled with the idea of revocation.

Senator DANIEL. Well, that seems to be a reasonable procedure. You should not revoke a license until a man has had a hearing and has been convicted by some other tribunal, unless there should be some proceeding to give a trial to an individual.

Do you have any procedure by which you yourself can revoke licenses on the basis of evidence before you?

Mr. FRANZONJ. We have a situation that every 3 years the individual pharmacist's license has to be renewed.

At that time, the Board of Pharmacy, if it has reason to believe the license should not be renewed, we are authorized to conduct, a hearing and to establish certain findings of fact, conclusions, and then either renew or not renew.

Senator DANIEL. I see.

Mr. FRANZONI. But that is an involved process, can only be brought into effect once every 3 years when the man's license comes up.

We have just recently spent 6 days in hearing on a proceeding that has been holding over for about 3 years, due to the legal maneuvering back and forth on the part of the individual to avoid such hearing.

Senator DANIEL. If you have any recommendations to this committee on this subject, we would appreciate receiving them later during our hearings before we finish in January. If you have anything at all to furnish to us, we would appreciate receiving it.

I want to see the legal profession get rid of the few who commit violation of the law and I know you want to do the same thing. Mr. FRANZONI. That is right.

Senator DANIEL. If you need any further help from Congress on that, please let us know.

Mr. FRANZONI. We are hopeful of having a complete new pharmacy law to submit to the opening session of Congress.

Senator DANIEL. Of this next Congress?

Mr. FRANZONI. Yes, sir.

Senator DANIEL. We appreciate that.

Although that might, if it is a separate pharmacy law, go to another committee, anything that is in connection with drugs, this committee might be able to give you an assist.

Mr. FRANZONI. Thank you, sir.

Senator DANIEL. Thank you very much.

Mr. Larrick?

Do you solemnly swear the testimony you are about to give to this subcommittee of the Senate Judiciary Committee will be the truth, the whole truth, and nothing but the truth, so help you God? Mr. LARRICK. I do.

TESTIMONY OF GEORGE P. LARRICK, COMMISSIONER OF FOOD AND DRUGS, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

Senator DANIEL. Will you state your name?

Mr. LARRICK. My name is George P. Larrich, L-a-r-r-i-c-k.
Senator DANIEL. And your official position?

Mr. LARRICK. Commissioner of the Food and Drug Administration, Department of Health, Education, and Welfare.

Senator DANIEL. How long have you held this position?
Mr. LARRICK. Just a little over a year.

Senator DANIEL. Mr. Larrick, have you made a study of barbiturates and amphetamines, and their use and misuse?

Mr. LARRICK. Yes, Senator Daniel; and, may I add that before I was Commissioner I was employed in the Food and Drug Administration for 31 years, so I didn't start my employment there a year ago.

Yes, sir, we have made such a study.

Senator DANIEL. Now the committee has asked you to give us testimony concerning both barbiturates and amphetamines. Mr. LARRICK. I wonder, Mr. Chairman—

Senator DANIEL. You have a prepared statement?

Mr. LARRICK. I do.

Senator Daniel. Do you have copies?

Mr. LARRICK. I gave copies to the counsel. I have copies of my statement. I have some additional material that Mr. Gasque asked me to get together, of which I only had one extra copy that I handed to him.

Senator DANIEL. All right, you may proceed.

Mr. LARRICK. Mr. Chairman and members of the committee: For many years the Food and Drug Administration has been aware of the fact that bartiturates, while very useful drugs in medicine, are especially dangerous drugs because, like the narcotics and some other drugs, susceptible individuals find their effects psychologically satisfying and they are inclined to use them for that reason. Our medical staff has prepared a summary of their use and abuse which is available to the committee if it is desired.

Senator DANIEL. Do you have that summary?

Mr. LARRICK. Yes, sir.

Senator DANIEL. We will make that a part of our record now. Mr. LARRICK. Fine; he has the summary.

(The document referred to follows:)

THE BARBITURATES-THEIR USE AND ABUSE

The barbiturates comprise an important and valuable class of central nervous system depressants. Chemically they are all derivatives of barbituric acid which is a condensation product of malonic acid and urea. By substituting various chemical groups in the barbituric acid ring a large number of barbiturates have

been produced. Over 2,500 barbiturates have been prepared and many of these have been carefully studied pharmacologically. Of these approximately 50 have been marketed for clinical use. Some of the more important ones have the commercial names of amytal, seconal, phenobarbital, nembutal, butisol, veronal, and pentothal. The list is large and many others could be mentioned.

PHARMACOLOGICAL ACTIONS

The major action of the barbiturates and the one for which they are employed in therapy is depression of the central nervous system. All the numerous sedative hypnotic barbiturates have the same general type of depressant action on the central nervous system and differ from one another mainly in the speed of onset of action, the duration of effect, and in usefulness for specific purposes. Any degree of depression from slight sedation to deep coma can be obtained with the barbiturates. The barbiturates are used more for the induction of sleep than for any other purpose. They may also be used for sedation, anesthesia, and anticonvulsant.

Hypnotic effect.—The barbiturates are used more for the induction of sleep than for any other purpose. With adequate oral doses of nearly any barbiturate, sleep occurs in 20 to 60 minutes. It closely resembles physiological sleep, but subjectively and with respect to electroencephalographic records. It is dreamless, and, as a rule, refreshing. Particularly when the long-acting preparations are used, there may be a hangover upon awakening. Even when there is no obvious hangover, as after the short-acting barbiturates, physiological impairment can be demonstrated for some hours after awakening if special psychomotor performance tests are used for its detection.

Anesthesia. In sufficient doses, barbiturates can produce surgical anesthesia. When ultra short-acting barbiturates are employed for surgical anesthesia, respiratory depression is more marked for a given degree of skeletal muscular relaxation than when inhalation (ether-gas) anesthetics are used. (Pentothal sodium is a good example of this effect.)

Analgesia. The barbiturates differ sharply from morphine and related alkaloids in that they lack significant ability to obtund pain sense without definite impairment of consciousness. The barbiturates are thus not true analgesics and cannot be depended upon to produce sedation or sleep in the presence of moderate to severe pain. When combined, however, with analgesic drugs such as salicylates, acetanilid, and codeine the combination may prove more effective than the analgesic agent alone.

Anticonvulsant action.-In anesthetic doses, all the clinically employed barbiturates are capable of inhibiting convulsions, such as occur in strychnine poisoning, tetanus, and status epilepticus. However, phenobarbital has a selective anticonvulsant action, especially useful in symptomatic therapy of epilepsy. This action is not shared by other barbiturates except mephobarbital and metharbital. The action is unrelated to sedation since nonsedative doses are often effective and because amphetamine counteracts the sedation without abolishing the anticonvulsant action. Why many other sedative barbiturates are not antiepileptic is unknown. Phenobarbital has been more extensively studied and hence its anticonvulsant properties are better understood.

Respiration. Barbiturates are respiratory depressants by virtue of their direct effect on the medullary respiratory center. The depression of respiration is proportional to the dose. A large hypnotic dose (for example, 0.2 gram, 3 grams of phenobarbital) decreases respiratory minute volume approximately 10 percent as compared to about 20 percent by 15 milligrams of morphine. Respiratory depression is the major danger in actute barbiturate poisoning, death usually being due to respiratory failure.

Cardiovascular system.-Ordinary hypnotic doses have no significant effect on the cardiovascular system. Blood pressure and pulse rate may fall somewhat as a result of the sedative action or sleep produced by the medication. A sharp but usually transitory fall in blood pressure may result from the rapid intravenous injection of a relatively safe dose of a barbiturate.

Renal effects.-Barbiturates have no direct injurious effect on the normal kidney. Anaesthetic doses cause transient decrease in kidney function similar to that seen associated with ether and cyclopropane anesthesia.

Liver.-Hypnotic doses do not impair normal liver function; indeed, even the very large amounts ingested daily for long periods of time by addicts do not cause liver damage. In patients who are hypersensitive to the drug severe liver damage can occur from ordinary doses. The liver is the chief organ for detoxification of the barbiturates. The barbiturates are broken down by the liver into other chemical compounds.