mittee knows, the ICC has very strict regulations which govern the amount of time which a drive may spend on the road. Currently this requirement is 10 hours of driving time between minimum 8hour off-duty periods with weekly maximum limitations. Further, every interstate driver must maintain a "driver's log" to record his hours. In addition to these stringent Government regulations most trucking companies schedule their drivers' runs so that they will be well within the maximum allowable driving time. Thus a driver complying with the ICC's safety regulations and his own company's policies should not need any "stay awake" type stimulus. Our cooperation with the Food and Drug Administration goes back many years since shortly after we first became aware of the problem. The Enforcement Division of FDA has joined with us in our efforts to stamp out illegal sales. Their agents have been trained by our member companies as drivers and helpers in order that they could make purchases and subsequent arrests. Enforcement officers have ridden thousands of miles on our trucks and have made hundreds of arrests while they were posing as employees of trucking companies throughout the United States. This, of course, could only have been accomplished with the complete cooperation of the management of our companies.

This mutual effort between the trucking industry and FDA has resulted in a number of arrests being made at truck stops and other highway type installations, and at the same time it has resulted in a great deal of bad publicity for the trucking industry and its drivers. Our files are replete with lurid, sensational stores based upon suspicion, hearsay, and pure fiction which purport to relate that truckdrivers generally use these drugs and thus are responsible for a major traffic hazard. This, as I have stated, cannot be borne out by ICC reports nor any other record we can find.

FDA has also worked with us in producing hundreds and thousands of pamphlets which have been distributed through our members across the country. Attached to this statement is the latest publication produced by the Food and Drug Administration with our cooperation. More than 100,000 copies of this pamphlet have been distributed through our industry. A previous pamphlet produced by ATA several years ago had more than a half million distribution in our educational work.

At this point we would like to call the attention of the committee to another great need in addition to this legislation but closely related to it.

In this day and age when Americans have become a nation of pill takers there are many drugs that are known to have side effects that may well interfere with the safe operation of motor vehicles. This suggests that we have in this area a national health problem. To the best of our knowledge, while there are numerous studies of the use of amphetamines in military services and by civilians to extend capabilities beyond normal fatigue, there are no adequate studies covering excessive use of these drugs nor the effect of other widely used drugs upon driving capabilities.

In its pamphlet "Drugs and Driving" the Food and Drug Administration makes this statement:

The Food and Drug Administration is concerned over the increasing threat to highway safety from drivers "under the influence" of drugs. The drugs involved

range from true narcotics to stimulants, tranquilizers, sleeping pills, and even some cold remedies (e.g., antihistamines). Some are widely used in such common ailments as nervousness, overweight, high blood pressure, and hay fever. Because of these common uses many people do not realize the effects drugs may have on driving ability. They may innocently contribute to the danger on the streets and highways.

It is obvious from this warning that there is pressing need for research work to determine the effects of these drugs on driving ability as well as on the national health. Both are concerns of every one in this Nation. Too, there is a definite need in the case of amphetamines for research to determine at what point of concentration in the bloodstream a person comes under the influence of the drug as has been done with alcohol to determine intoxication. Especially is this need great if there is any foundation for the belief that this particular drug constitutes a real threat to highway safety.

We urge and are most hopeful that the committee will act favorably upon the pending legislation to the end that this problem will be eliminated both for our industry and for the public as a whole. Thank

you.

Senator YARBOROUGH. You said in the first statement of the report that you supported this bill, and you ended up in the last paragraph by saying that you were still for it. This is not always the case, and I commend you.

Mr. FORT. Yes.

Senator YARBOROUGH. Mr. Fort, I have driven hundreds of thousands of miles on the highways-I drove one car alone over 100,000 miles, I have campaigned extensively in politics, and sometimes have been forced to drive my own car all night after working during the day, so I have some personal experience with highway fatigue. My own experience is that the average truckdriver, as I meet him on the highway, is a much more courteous, capable driver than the average driver. I have learned, through driving hundreds of thousands of miles, that you can expect the courtesy of the road from him, but you cannot rely on the average car. The truckdriver is not likely to turn left without a signal or come through a stop sign that you must watch out for all the time from other drivers. But you learn from experience that bad driving practices are more apt to be associated with nontruckdrivers than with truckdrivers.

I agree with your conclusion that the truckdriver is not to be singled out as a bad example of driving habits in America. On the contrary, I think his driving standards are higher than the average. Mr. FORT. Thank you, sir.

Senator YARBOROUGH. Any further questions-any questions by

the staff?

Gentlemen, thank you.

Thank you, Mr. Fort. That concludes the hearing today. We will leave the record open until Thursday of this week for any additional statements that anyone wishes to file. That will then be the last day, and then the record will go to press.

(The following material was received from witnesses who were unable to be present:)

PHARMACEUTICAL MANUFACTURERS ASSOCIATION,

Washington, D.C., August 3, 1964.

Re S. 2628, 88th Congress.

HON. LISTER HILL,

Chairman, Subcommittee on Health,
Committee on Labor and Public Welfare,

U.S. Senate, Washington, D.C.

DEAR SENATOR HILL: The Pharmaceutical Manufacturers Association welcomes the opportunity of expressing its views concerning S. 2628, introduced by Senator Thomas J. Dodd on March 12, 1964, and referred to the Senate Committee on Labor and Public Welfare. The PMA has long been interested in and has consistently supported Federal legislation intended to impose additional controls on the distribution and sale of certain depressant and stimulant drugs. Specifically, the PMA favors legislation:

1. Requiring the registration of all those engaged in the production of depressant and stimulant drugs which have been the subject of abuse;

2. Requiring persons who distribute these drugs to maintain adequate and accurate records so that all production may be accounted for and traced from the manufacturer through every step in the chain of distribution to the ultimate con

sumer;

3. Imposing stringent penalties against the illicit manufacture, distribution, or sale of these drugs; and

4. Limiting the controls to those drugs which have been shown to have been actually abused,

For the consideration of the subcommittee, the PMA submits the following comments and recommendations:

In the purpose clause, the term "habit forming" should not be used to describe amphetamines or other central nervous system stimulant drugs. As applied

to these drugs, the term is unwarranted and in a very real sense misleading. "Habit forming" as used presently in the Food, Drug, and Cosmetic Act, section 502(d), is applied to many drugs which may produce physical dependence, with the consequent appearance of the abstinence syndrome upon withdrawal of the drug. It is well recognized that the stimulant drugs under question are not "habit forming" in this sense. (See sec. II-3 of exhibit I appearing on p. 10 of the "Report of the President's Advisory Commission on Narcotic and Drug Abuse," issued in November 1963.)

The habit-forming qualities of both the barbiturates and the amphetamines would appear to be irrelevant. Indeed, the available evidence would indicate that the social abuse of both classes of drugs is not related to any habituating qualities which they might possess.

The abuse problem is related to their "thrill use" by those seeking antisocial effects. Amphetamines are also misused by those seeking to prevent the onset of sleep and fatigue. None of these uses creates a compulsive desire for continued use; the drugs are used only in the specific instances when the individual wishes to experience the pharmacological effect produced by these drugs.

The term "habit forming" blurs the objective of the bill which is to provide a means for controlling all drugs that may be subject to social abuse. (See the first sentence of sec. 1 on p. 44 of the President's Advisory Commission report.)

If the recommendation for deleting "habit forming" from the purpose clause is adopted, it should also be deleted from numerous other passages of the bill. The word "psychotoxic" is used in the title of the act principally to describe amphetamines and barbiturates. This is an unfair designation because it stigmatizes these medically useful drugs.

Amphetamine is a central nervous system stimulant. Such stimulants are widely used to combat a variety of mild depressive states, such at those attending the menopause, chronic organic diseases, and postoperative recovery, and are drugs of choice in the treatment of narcolepsy, postencephalitic parkinsonism and enuresis in children. These drugs are also extensively prescribed singly or in combination with barbiturates as an aid in the treatment of obesity, for they produce both an anoretic and antidepressant effect.

In therapeutic doses, amphetamines and related sympathomimetic drugs produce a general state of well-being, coupled usually with some increase in motor activity. In excessive quantities greatly increased hyperactivity can be produced; but even when so used, amphetamines and related drugs do not produce physical dependence, and the tolerance which develops for them rapidly disappears upon abstinence.

It is estimated that between 5 and 10 million cases are treated by physicians each year utilizing central nervous system stimulant drugs. Hypnotics are even more widely used therapeutic agents, for it may be estimated that approximately 20 million cases receive some treatment with barbiturates each year.

Barbiturates, including such well-known drugs as amobarbital, pentobarbital, phenobarbital and secobarbital, are widely prescribed hypnotics and sedatives. They are central nervous system depressant drugs.

These compounds are indicated for use in insomnia, nervous tension, hysteria, for general anesthesia, in labor, in pyschiatric treatment and other indications. Barbiturates are technically denominated "habit forming" in section 502 (d) of the Federal Food, Drug, and Cosmetic Act. When used in the doses usually prescribed, however, they carry no real hazard of tolerance or physical dependence. From the above, it is obvious that there is a widespread legitimate medical use of these drugs. There is no more reason for calling the above drugs "psychotoxic drugs" than there is for calling automobiles "crash cars" merely because the driving privilege is abused by many people.

In this connection it should be noted that though the President's Advisory Commission report defines psychotoxic drugs in the introduction, the body of the report uses the term "dangerous drugs." For example, on page 43 of the report, the heading used is "Dangerous Drugs." This terminology is subject to the same criticism as the term "psychotoxic drugs," since it suggests that such drugs are dangerous and their use should be avoided, whereas it is in fact abuse which is sought to be prevented.

For the reasons suggested above, the term "psychotoxic drugs" should be deleted from all other parts of the bill, and the title of the act should be changed to "Depressant and Stimulant Drug Abuse Act of 1964." The drugs intended to be covered can thus be accurately described and the purpose of the bill clearly indicated without resort to terms which might produce a public reaction inhibiting legitimate medical uses. Conforming changes should be made where necessary

throughout the bill.

No drug should be placed under the controls established by the act unless there have been enough instances of abuse to constitute an immediate threat to the public health and safety.

No standard is set by the proposed statute for determining when there have been enough instances of abuse to constitute a threat to the public health and safety. Furthermore, the information concerning the misuse of depressant and stimulant drugs is nonprecise, incomplete, and largely unsubstantiated by definite proof of causation. This means that the determination of which drugs shall fall within the scope of the statute, or removed therefrom, is a matter of considerable difficulty, requiring a broad range of viewpoints and opinions.

The PMA heartily supports the following recommendation appearing on page 44 of the President's Advisory Commission report:

"In determining the specific drugs which fall within the scope of his regulatory power over dangerous drugs, the Secretary of Health, Education, and Welfare should be advised by a standing committee composed of experts from both within and without the Federal Government and should act in accordance with fair rulemaking procedures."

The evidence relating to those barbiturates and amphetamines which have been abused indicates that most of the alleged misuse is limited to certain varieties and forms of drugs which are legally available only on prescription. There appears to be little abuse of those prescription forms which are so combined with other drugs as to prevent the ingestion of sufficient quantities to cause either a central nervous stimulant or hypnotic effect; nor is there evidence that over-the-counter preparations containing either of these types of drugs are presently capable of abusive non medical use. The PMA recommendation therefore is to exempt these combinations and over-the-counter products. On this point the President's Advisory Commission report states (p. 44):

"The bill should exempt any drug within this definition that combines a small amount with other substances where the resultant drug is not itself liable to abuse." The provisions of section 3(a) of the bill permitting the Secretary to add addiitional habit-forming" stimulants, should be deleted. Toxic effects or social abuse, not habit formation, should be the criterion for including drugs within the scope of the act.

There is another compelling reason for such elimination; namely, that its provisions are covered by the broader terms discussed immediately below.

The provisions of (v) (3) of this same section give the Secretary the power to bring drugs within the scope of the act by designating them as having "a potential

for abuse that may result in psychotoxic effects or antisocial behavior." This criterion sets the stage for purely theoretical determinations. Conceivably, the Secretary could include any drug that produces desirable sensations on the ground that it has the potential for abuse. As noted above, only those drugs which have been actually abused should be subject to the controls of the bill.

Section 511(c), as proposed in the bill, exempts from the illegal possession provision a person who possesses the drug "for the personal use of himself or of a member of his household." This exemption should be broadened so as to include other legitimate possession.

The proposed section 511(d) provides that every person engaged in compounding or otherwise disposing of any controlled drug shall prepare and maintain certain records, including names and addresses of vendors and vendees. Most of the necessary records are presently made as a matter of course by manufacturers and wholesalers who normally keep account of the names and addresses of their suppliers and customers. No undue burden will be imposed on them as long as there are no set forms or separate records required.

The PMA, therefore, recommends the addition of a provision along the following lines:

There shall be no set forms or separate files for the records required under the act so long as the necessary information is available.

The PMA respectfully requests that this letter, expressing its views on S. 2628, be included in the record of the subcommittee's hearings.

Sincerely yours,

AUSTIN SMITH, M.D.

PREPARED STATEMENT OF RANDEL SHAKE, DIRECTOR, NATIONAL CHILD WELFARE COMMISSION, THE AMERICAN LEGION

Mr. Chairman and members of the subcommittee, I am Randel Shake, national child welfare director for the American Legion and located at its national headquarters in Indianapolis, Ind. The testimony herewith submitted is in behalf of the American Legion's National Child Welfare Commission of which David V. Addy, of Detroit, Mich., is national chairman. Our testimony is in support of Senate bill 2628 introduced by Senator Dodd and designed to better control the so-called dangerous drugs.

History has an odd way of repeating itself. In the early months of 1950 many volunteers in the vast child welfare program of the American Legion began reporting an alarming increase in the illegal use of narcotic drugs and most disturbing, the unbelievable increase in the use of narcotics by juveniles. reports reached our national headquarters primarily through our area child welfare conferences held annually in five different sections of the Nation.

These

When these reports were studied by the national child welfare commission itself it was learned that the reports were unfortunately true. As a result our first resolution regrading illicit use of drugs was adopted by our national convention in October of 1950.

Early in 1951 the American Legion held its now famous "Narcotics Crisis Conference" in New York City. The purpose of the conference was to spotlight for the Nation the alarming increase in the illegal use of narcotics, especially by juveniles.

Subsequently, as an organization we adopted a 15-point program at our 1951 national convention designed to help control the growing use of narcotics. It is with great appreciation that the American Legion recalls the action of the U.S. Congress at that time in adopting into law many of the points recommended in our 15-point program. It is also with some feeling of justifiable pride that we studied statistics of law enforcement agencies, the Public Health Service, and others and noted the improvement, particularly among juveniles in the whole illegal narcotic complex.

But now we find history repeating itself. In the latter part of 1962 and early part of 1963 again the delegates to our five area child welfare conferences began reporting to us the extensive and serious unprescribed use of dangerous drugs by many young people of high school and college age. We found from reports that the illicit and promiscuous use of such drugs was not limited to any one section of the United States. We found further that the drugs commonly being used could be harmful, habit forming, and could cause serious permanent damage when unsupervised by competent medical personnel.