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Mr. LARRICK. It is a black and white reproduction.

Senator DANIEL. Of the information you are talking about?

Mr. LARRICK. Yes, sir.

Senator DANIEL. The black and white picture?

Mr. LARRICK. Yes, sir.

Senator DANIEL. Of the exhibit that you have given me here that I hold in my right hand?

Mr. LARRICK. It is, sir.

Senator DANIEL. We will make this reproduction a part of the record at this point.

(The document referred to follows:)

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Senator DANIEL. I notice different colors are used here for all these pills. Are these colors and various designations on here required under the Pure Food and Drugs Act?

Mr. LARRICK. No; most of the colors, Senator, are trademarks used by the manufacturer.

All of these are legitimate articles of commerce, and they all have very useful purposes in medicine when they are properly controlled. The manufacturer adopts a trade-mark, and ordinarily he likes to have a distinctive appearance for his article.

The thing that is required under the Pure Food and Drugs law is to identify the article by its chemical name which, in the case of barbiturates, are long, involved names, and in the case of the drugs below, they are officially known as amphetamines.

Senator DANIEL. All right.

Mr. LARRICK. Dressed like denizens of the section, our inspectors easily bought barbiturates in any desired quantity with no questions asked. After identifying the store doing the biggest business with this kind of trade, they developed evidence which enabled the district attorney to file a case against the owner, who was also the principal offender.

Because of the sincerity on the part of the professional associations we were greatly impressed when their representatives came to us about 1950 and said they believed the practicing pharmacists were confused by the law. The delegation suggested that all interested parties should ask the Congress to amend the act in the interest of clarifying it.

This cooperative approach resulted in the Durham-Humphrey amendment of section 503 (b) which became effective in April 1952.

The amendment divides all drugs into two classes: (a) Those too dangerous for lay use; (b) those for which adequate directions can be written so that the layman can safely treat himself. The dangerous. drugs must bear the statement "Caution: Federal law prohibits dispensing without prescription." To avoid the former confusion, the amendment makes it equally unlawful to put the legend on a drug which actually is suitable for self-medication.

This amendment makes it a misdemeanor to dispense prescriptionlegend drugs except on the prescription of a physician or other licensed practitioner. It also makes it illegal to refill a prescription without the express oral or written authorization of the prescriber.

Senator DANIEL. Could that oral authorization be given on the telephone?

Mr. LARRICK. It may, in which event the pharmacist is required to make out what amounts to a prescription to show he took it over the telephone, and to make a record of it in his prescription file.

Senator DANIEL. How does he know it is not someone calling him, representing himself to be the doctor?

Mr. LARRICK. There is always the chance that is the case, and that has occurred, but after a great deal of consideration, both the Senate and House committees felt that the greater good would come from an oral prescription.

They spoke, for example, of times when the child is sick in the middle of the night, and the mother calls the physician, and he knows what the ailment is in the community, and he calls the pharmacist and gets the child the medication.

It may well be that we ought to take another look at that at some other time with respect to these particular drugs, but I personally am convinced that, as an overall proposition, there is a need for oral authorization of medicine in some cases.

Senator DANIEL. Because that applies not only to barbiturates but to many other dangerous drugs.

Mr. LARRICK. Exactly.

Because barbiturates are socially detrimental drugs, special effort has been made to locate and correct abuses. Our inspectors arrange with local authorities to report any information they acquire and we receive leads from hospitals, police departments, medical associations, ethical pharmacists, State food and drug officials, and from any source that might learn of such abuses in the course of routine business. addition, we often receive letters or visits from members of families.

In

about an addict in their house. Rumors regarding the illicit distribution of barbiturates are given top priority for investigation.

The Bureau of Vital Statistics records deaths from this cause and we have prepared a table from the data available. Although it separates the accidental from the suicide, it must be remembered that a death is classed "suicide" only if a note stating the intention is found. We have indicated the death rate per hundred million for these years. The relationship is shown by the graphs.

It is interesting that the total death rate has dipped slightly in recent years. While no valid conclusion can be drawn, we would like to hope it reflects an increased awareness of the drug's dangers on the part of everybody. A person bent on suicide will probably always be able to get the drug by hook or crook, but the truly accidental death can be prevented. Such accidents occur when young children get hold of the capsules; also, when an adult takes enough of the drug to make his memory fuzzy. He may not remember how much he has ingested and keep on taking it until a lethal amount is reached.

Incidentally, it has been suggested several times that the law should require the manufacturer to put ipecac in these drugs so they will be vomited when too many capsules are taken; we have established in our laboratory with animals and with human volunteers that this will not work, because the drug depresses the vomiting mechanism, and the emetic fails to work. So the combination of the emetic and the barbiturate is more dangeruos than the barbiturate alone.

In our opinion, the death rate is probably no index as to whether the problem is increasing or decreasing. The total social effects are quite comparable to those of chronic alcoholism. The individual victim, his family, neighbors, and society generally may suffer from the detrimental effects of addiction for years and the addict die from some other immediate cause.

Undoubtedly many people die from accidents while under the influence of the drug and the true cause is never identified. For example, we know of a man who fell into an open gas furnace and died from the burns he was too stupefied to feel. People under the influence of the drug may be killed as pedestrians or kill themselves or others in automobile accidents. Since there is no odor to reveal it, barbiturate intoxication is an insidious thing. For that reason it is not always suspected by persons investigating accidents.

Addiction produces a general dissolution of character. We know of men who have held responsible positions but gradually became derelicts through the use of these drugs. Whole families may become relief problems when the breadwinner becomes addicted. Oftentimes housewives begin to use the drug on a doctor's prescription for a nervous condition; they gradually increase the dosage as tolerance and emotional and physical dependence develop. They no longer take an interest in the home or children, get dirty and slovenly; steal money and sell furniture to get the drug. Again, because the drug is odorless, the victim may be far along before the family recognizes the real trouble.

We have never been able to estimate how many people may be using these drugs to excess. The annual domestic production is hugelast year about 798,000 pounds. This would make over 3 billion capsules of 11⁄2 grains of the usual size dose or an average of about 18 doses per year for each man, woman, and child in the United States.

Since these data were prepared, we have gotten some figures from one of our other bureaus telling the exact amount that was exported. So in the year-I would like to hand up this table which will show the total production in pounds, the total export in pounds, and the remaining amount would be regarded as that used in the United States, and that would make the figure that I gave of 18 doses, reduce it slightly, because some of it that we calculated 18 doses from was actually exported.

Senator DANIEL. The table will be made a part of the record at this point.

(The table referred to follows:)

Total production of barbituric acid derivatives from statistics compiled by U. S. Tariff Commission 1

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I Data compiled before 1941 not complete, since it was only for phenobarbital and phenobarbital sodium. Production figures include the total output of the reporting companies' plants-the materials produced for consumption within the plants, as well as those produced for sale, including export.

2 Figures not available before 1949. Bureau of Census figures.

• Preliminary.

Mr. LARRICK. The professional acts of licensed practitioners are clearly beyond the scope of this act. However, we have named doctors as codefendants with druggists in a few instances when the evidence made prosecution legally possible. Such cases involved doctors who, for a fee, wrote blank prescriptions which the druggist filled in for the customer as needed, or who signed prescriptions the druggist wrote. We were prepared to prove in such cases that the doctor had never laid eyes on the inspector whose name appeared on the prescription bearing his signature.

Recently, we filed a case against a physician who furnished barbiturates and amphetamines to our inspectors under circumstances which we will attempt to prove removed the transactions completely from the sphere of his professional practice and the bona fide doctorpatient relationship. In addition to this case, we know of a number of doctors, about 20, who are either recklessly dispensing such drugs on a commercial basis themselves or selling prescriptions for them. It is difficult to take effective action in cases like this because it is not always possible to demonstrate to the satisfaction of a court that the physician's acts are not part of his professional prerogatives. Senator DANIEL. I believe that completes your testimony concerning the physicians?

Mr. LARRICK. I believe, yes.

Senator DANIEL. I see you go to pharmacists.

Mr. Larrick, you say you have outlined all the control you have over the physicians in the use of barbiturate drugs?

Mr. LARRICK. That is correct.

Senator DANIEL. Are you prepared to make any recommendations to the committee concerning further records or further controls that should be exercised over physicians in this matter?

Mr. LARRICK. I am not prepared to make any recommendations for further controls over physicians at this time.

I would like to recommend that everything possible be done to stimulate cities and States to pass laws and to get facilities, to assume as much of this problem as possible.

I personally do not look with favor on our taking over any part of this problem that can properly be done by the States.

Senator DANIEL. That is good philosophy all the way down the line: is it not?

Mr. LARRICK. There has been pretty much of a vacuum in this field in the States, and many times people will look at the record of how many States have laws, how many may have good laws, but you have to look deeper than that, you have got to look and see if they have facilities to enforce those laws.

The surveys we made, and one of them was completed just a little over a year ago, showed that too few of them have good laws, and of those that have good laws, very few have enough people to do the job.

In your own State, Texas, they have people down there who can do a wonderful job in pure food and drug work, and they have a fair law, in my recollection of the State, and they know as much about enforcing it as we do, but they do not have the facilities, and that is true of the States, generally.

Senator DANIEL. When I was attorney general we presented for the legislature, and they enacted, a very stiff law on barbiturates. It covers what pharmacists can do, and how they had to control them. Are you familiar with the details of that law?

Mr. LARRICK. I have talked to the man in charge of the enforcement of the law, but I would not say that I have read it recently enough to have it in complete detail, but they didn't get any facilities to amount to anything to enforce it.

Senator DANIEL. You think they have a law like other States, but they do not have the enforcement facilities?

Mr. LARRICK. If you can get good strong local enforcement in this type of area, where you are dealing really with a retail operation, you can do a better job.

The man who lives in the community, he knows the druggists there in that community, and 99 druggists out of a hundred are just as honest as these lawyers you are talking about.

But then there are 1 or 2 questionable characters among them. Well, the local man knows all about that, and if you can give them good local laws they can do a good job.

That doesn't mean the Federal Government should not be there to backstop, but I would prefer to see as much of it done by the States and cities as can be, and the Federal Government stepped into the big stuff that involves pretty much interstate commerce.

Senator DANIEL. All right, sir.

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