HABITUATION AND ADDICTION

Habituation to the barbiturates in the sense of psychic dependence is frequent
and certain individuals may experience craving and psychic disturbances when the
drug is withdrawn after a period of chronic administration. This phenomenon
is rather characteristic of the hypnotic-sedative group of drugs. Addiction can
develop to the barbiturates in the sense of the term as defined by the drug addic-
tion committee of the National Research Council and as incorporated in the
definition of addiction of the Expert Committee on Drugs Liable To Produce
Addiction of the World Health Organization. Since the barbiturates are so
widely used for therapeutic purposes and since most people have been introduced
to them by their physicians at one time or another it is safe to state that barbitu-
rate addiction is more widespread than for any other drug. Addiction to barbitu-
rates is more serious than that to morphine; in fact, although addiction to bar-
biturates resembles that to morphine in that tolerance and emotional and physical
dependence develop, barbiturate addiction is a more serious public health and
medical problem because it produces greater mental, emotional, and neurological
impairment and because withdrawal entails real hazards. These hazards include
weakness, anxiety, convulsions, delirium, and, in some cases, death itself. Fre-
quently hallucinations and delusions are also present.

Number of deaths from acute accidental poisoning by barbituric acid and derivatives
and number of suicides

1 From Vital Statistics of the United States summary and rate table. National Office of Vital Statistics,
Public Health Service, Federal Security Agency.

2 Preliminary.

1948.

1949.

1950.

1951.

Time devoted to investigate improper sale of prescription-legend drugs

1 24.2
21.7

25, 252

36, 859

36.9

22, 937

1 Estimated from total project hours, basis experience fiscal years 1953-55, inclusive. (Reporting system
used prior to fiscal year 1953 called for total field project time only.)

Mr. LARRICK. For years a good many doctors regarded them as
relatively harmless; possibly habituating but not addicting drugs.
Only within the past few years have they been properly classified as
truly addicting drugs within the medical definition of that term.

For the last 15 years the Food and Drug Administration has tried
to curb an apparent increasing abuse of these drugs. While our regu-
latory programs aim at preventing the dispensing of any dangerous
drug to persons who are not going to use it under the direction of a

71515-56-pt. 6- 8

physician, special attention is given to the barbiturates because they are the most likely to cause injury when misused.

Because barbiturates produce greater mental, emotional and neurological impairment than morphine, informed medical experts express the opinion that addiction to them is actually more detrimental to the individual and society than morphine addiction.

Like morphine, barbiturates produce physical dependence; but withdrawal of barbiturates is even more serious-in some cases, patients even die during withdrawal.

The Food, Drug, and Cosmetic Act makes very little distinction between barbiturates and other dangerous drugs. The only special provision names barbiturates (among a number of drugs) as habitforming drugs and the label must state that fact.

Since these and other dangerous drugs are restricted to dispensing only on prescription, the warning about habit formation has no value to the consumer receiving the drug in a package with prescription labeling on it. Because the law makes no special provision for control of barbiturates, our activities against their illicit distribution are inseparably interwoven with those against the sale of antibiotics, hormones, thyroid, sulfonamides, and so forth.

The most important section of the act, so far as preventing the misuse of harmful drugs is concerned, is the amendment of section 503 (b) which became effective in 1951, popularly known in the drug trade as the Durham-Humphrey amendment.

Up to that time the control exercised under the act of 1938 was under the general term of the statute and implementing regulations. A survey showed that there was inadequate control by the States because of the lack of appropriate laws, lack of money for enforcement of whatever laws might exist, or, in some instances, because officials were not completely aware of the public danger involved.

We had been receiving information from our inspectors and various other sources about specific injuries being caused by the unintelligent use of potent drugs by laymen; we were especially concerned about reports on the abuse of barbiturates. Vital statistic figures showed increased accidental deaths and suicides with them.

While other drugs had their dangers, the widespread damage barbiturates can do to society as well as to the individual made us especially aware of the need for their control.

Senator DANIEL. I believe right there that barbiturates are used more in suicide cases today than almost any other poison?

Mr. LARRICK. The statistics on deaths from barbiturates show that the total number of deaths reported by bureaus of vital statistics in 1933 was 215.

By 1953, 20 years later, there was reported in a preliminary way, because all the figures may not be in, 953 deaths.

I have here, if you care to have it for the record, a breakdown of the vital statistics from deaths by barbiturates, and a division of those cataloged as accidental and those that are suicide.

Senator DANIEL. Yes. Let us make this table which is entitled "Number of Deaths From Acute Accidental Poisoning by Barbituric Acid and Derivatives," and the number of suicides, let us make that a part of the record at this point in your testimony.

Mr. LARRICK. Very good, sir.

(The document referred to follows:)

Number of deaths from acute accidental poisoning by barbituric acid and derivatives and number of suicides

1 From Vital Statistics of the United States, summary and rate table, National Office of Vital Statistics, Public Health Service, Federal Security Agency.

* Preliminary.

Senator DANIEL. Let us give the 1953 figures which you say are not complete. They show that accidental deaths were 337, suicides, 616, or a total of 953.

Mr. LARRICK. Correct, sir.

Senator DANIEL. These are from barbiturate drugs alone?
Mr. LARRICK. From barbiturate drugs alone.

Should I continue?

Senator DANIEL. Yes.

Mr. LARRICK. Our early efforts were primarily educational. Through the cooperation of the boards of pharmacy and other State and local officials, we called attention to the requirements of the law and tried to encourage local communities to enact supporting laws.

Professional societies and associations issued special bulletins to their members and carried articles on the subject in their journals. The drug trade press assisted greatly when it seemed that regulatory actions were needed to support the educational program the Administration began to develop cases.

Senator DANIEL. Mr. Larrick, going back to this table, I notice there is a terrific increase since 1944 on suicides by the use of barbiturate drugs.

Mr. LARRICK. That is right.

Senator DANIEL. By 1944, 250; 1953, 616; so it would appear that both accidental deaths and suicides are increasing, by looking at this table.

Mr. LARRICK. Well, you will notice though, Senator, that from a high of 764 in total deaths in 1949, that is the peak, and then if you drop down to 1953 it has dropped down to 597.

I do not think anyone can make a firm interpretation of those data. But the decline in the latter years there does coincide with increasing enforcement of the Federal law, and increasing attention at the local level.

Senator DANIEL. That is, the figures you have just given are deaths per 100 million population?

Mr. LARRICK. That is right.

Senator DANIEL. In other words, that is the percentage figures? Mr. LARRICK. That is right; the population.

Senator DANIEL. Our population increasing would bring down your percentage of people who have died by use of the drug?

Mr. LARRICK. That is right.

But in the next column, which contains the totals, you had a high in 1945 of 1,141 deaths, whereas in 1953 that had dropped down to 953-1,140 in 1949 down to 953 in 1953.

Senator DANIEL. So actually the peak was in 1948 through 1951with each year over 1,000 deaths from accidental causes and suicides together?

Mr. LARRICK. Correct.

Senator DANIEL. However, the drop to 953 for 1953, is not too much below. It is still at a dangerous level, wouldn't you say? Mr. LARRICK. Very much, too high.

I have a chart here that portrays that. I do not know whether there is any use in dwelling on it any more. I guess you canvassed that pretty completely, but I have just drawn it out, and it shows the same facts you have recited.

Senator DANIEL. Yes. If you will make a copy of it available, we will put a copy of the chart in the record.

Mr. LARRICK. All right.

(The chart referred to appears on p. 2223)

Mr. LARRICK. Should I continue, sir?

Senator DANIEL. Yes, sir.

The

Mr. LARRICK. One of the earliest cases was brought against a retail store in Waco, Tex. At that time Waco was plagued by the disorderly conduct of skid-row characters who used barbiturates, either alone or with cheap wine to increase the effects of both. police had no authority to stop sales to these derelicts; they could only lock them up after their bad behavior commenced. The jail was equipped to process a normal number of drunks daily because they could be released in a few hours; the "goof ball" users were stupefied for 2 or 3 days. Because they could not be safely released their detention exhausted cell space and filled the jail to overflowing. Senator DANIEL. This use of "goof ball," is that a slang expression? Mr. LARRICK. Yes; that is a slang expression for a form of barbiturate.

All of these different pills have nicknames in the underworld, and I have here, sir, if I may approach the bench

Senator DANIEL. Yes, sir.

Mr. LARRICK (continuing). To exhibit that, we have prepared to loan to police departments throughout the Nation so that the police, when they arrest these characters and find some pills on them, will be able to identify them with the type of pill that it is, and we think this will help in this problem by identifying the cause of the person's intoxication.

Senator DANIEL. You have a reproduction? Is this reproduction I hold in my left hand

Mr. LARRICK. That is right.

Senator DANIEL (continuing). A reproduction of the frame