Mr. ANDREWS. Under your contracts you have one for fiscal 1970 under item C. You will discover where and how drugs are diverted from legal channels. $200,000 for the study?

Mr. INGERSOLL. Yes, sir.

Mr. ANDREWs. Is that not something pretty basic which should have been done long before many of these other studies had been made?

Mr. INGERSOLL. I think so; yes, sir.

Mr. ANDREWs. That is your priority study for fiscal 1970?

Mr. INGERSOLL. Yes, that has high priority.

Mr. ANDREWs. That is all, Mr. Chairman.

We also wish to call to the attention of the Subcommittee the exchange between Mr. Ingersoll and Congressman Andrews under the heading of "Control of Traffic"-pages 981-983. In response to Congressman Andrews' suggestion that only "a very small percentage of druggists in the United States would be involved [in illegal diversion]" Mr. Ingersoll remained silent. In discussing diversion of amphetamines and barbiturates, Mr. Ingersoll stated:

"We estimate that about 92 percent of the amphetamine and barbiturates used in the drug industry are diverted at the wholesale or retail level. We are making a study to find out where diversions are taking place" (emphasis added). We wish to make several observations about the above quoted statement. First, it also establishes that the Bureau is unable to state with any certainty, to what extent and where illegal diversions occur. To the extent the statement identifies the wholesale and retail levels of drug distribution as points of diversion, it does not distinguish between them quantitatively, and it does not implicate the pharmacist or wholesaler in the diversion. Whatever the amount of diversion at these levels, the most significant causes are the criminal acts of others involving break-ins, holdups and hijacking of drug shipments.

So far as the conduct and attitude of pharmacists are concerned, we think they are best illustrated by Mr. Ingersoll's answer to a question regarding the sale of exempt narcotic preparations:

"When we know a large supply is being sold out of a drugstore, we will go to the druggist and warn him and 90 per cent (emphasis added) of them do take care of this matter."

During hearings on the Controlled Dangerous Substances Act of 1969 (S. 1895 and S. 2637) before the Senate Subcommittee to Investigate Juvenile Delinquency of the Senate Judiciary Committee, Senator Dodd made several references to a study by the Food and Drug Administration between 1953 and 1963 in an attempt to impune the profession of pharmacy as a major source of illegal drug diversion. We are quite familiar with that study and wish to put it in context. During the ten year period reported, a total of 1,658 convictions for diversion were obtained against pharmacists and other pharmacy employees. The average per annum conviction rate for both pharmacists and non-pharmacist employees was 168. During each of these years, there were over 100.000 pharmacists in practice and 50,000 pharmacies in operation. Senator Dodd asserted during our testimony that "between 1953-I don't have them up-to-date, but up to three or four years ago, 60 per cent of the convictions for illegal sales of amphetamines alone, involved pharmacists; and for barbiturates, 94 per cent; and for illegal sale of both, it was 94 per cent." (Page 749.) This mathematically impossible statement must also be considered along with the fact that probably 95 per cent of these and all other drugs pass through the pharmacist's hands in the legitimate channels of distribution. As was pointed out by one of our witnesses to Senator Dodd. this type of inflammatory statement can be compared to the unimpeachable statistic that 100 per cent of those convicted of passing red lights are automobile drivers.

We are convinced that criminal activity in drug distribution by pharmacists is infinitesimal when compared to the number of those practicing and to the total number of drug products and dosage forms passing through the hands of pharmacists in the health care delivery system. We trust that you and members of your Subcommittee will likewise be persuaded that this is so.

Sincerely,

WILLIAM S. APPLE, PH. D., Executive Director.

§ 151.424 CONDITIONS OF EXEMPTION FOR CLASS "X" PRODUCTS

(d) Retail sale restrictions. A Class "X" product may only be sold at retail without a prescription by a registered pharmacist and not by a nonpharmacist employee even if under the direct supervision of a pharmacist. However, after the pharmacist has fulfilled his professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a nonpharmacist. A pharmacist must exercise professional discretion in the sale of a Class "X" product to insure that the product is being sold for medical purposes only. An abuse of such discretion shall subject the pharmacist to the penalties provided for violations of the law relating to narcotic drugs. (e) Age of purchaser and identification. A Class "X" product may only be sold at retail without a prescription to a person at least 18 years of age. The pharmacist must require every retail purchaser of a Class "X" product to furnish suitable identification, including proof of age when appropriate, in order to purchase a Class “X” product. The name and address obtained from such identification shall be entered in the record of disposition to consumers required by paragraph (b) (2) of this section.

(f) Quantity restrictions. Not more than 2 ounces of camphorated opium tincture (paregoric), nor more than 8 ounces of any other Class "X" product containing opium, nor more than 4 ounces of any other Class "X" product, may be sold at retail to the same consumer in any given 48-hour period without a prescription.

Effective date. These amendments shall become effective on November 1, 1969. Mr. ROGERS. What did you say?

Mr. ROBERTS. These are exempt narcotics. They tend to be the cough preparations.

Mr. ROGERS. You cannot sell more than what amount?

Mr. ROBERTS. Four ounces in a 48-hour period. You also cannot sell to a person under the age of 18 without a prescription.

Mr. ROGERS. Does anybody ever do that?

Dr. APPLE. This regulation only recently went into effect.

Mr. ROGERS. Do you think it will be adhered to?

Dr. APPLE. We think it would be most unfortunate if pharmacists don't adhere to it closely.

Mr. ROGERS. Are they required to keep an inventory of these particular drugs and how they are dispensed, and to whom?

Dr. APPLE. Yes; they are.

Mr. ROGERS. So they would have a record of it.

Dr. APPLE. Yes, sir.

Mr. ROGERS. I see.

Are there other questions?

Thank you. Your testimony has been most helpful.

Our next witness is Dr. Nathan S. Kline, of New York.

Dr. Kline, the committee welcomes you here, and we appreciate your testimony.

Mr. HASTINGS. Mr. Chairman, I would like to particularly be able to welcome Dr. Kline. I am aware of Dr. Kline in his position at the Rockland State Hospital. He is very well known, and I am sure, Doctor, that you will make a great contribution to the deliberations, and I welcome you here personally.

Mr. ROGERS. I might say, Doctor, before you begin, that the committee is aware of your reputation, and we are honored to have you

here.

The member from New York, I am sure you know, has made an outstanding contribution to the work of this committee.

STATEMENT OF DR. NATHAN S. KLINE, NEW YORK, N.Y.

Dr. KLINE. Thank you, Mr. Chairman. I would like to begin my statement with a quotation:

PRIMUM NON NOCERE

"Part of the discipline the physician learns is when not to act. Pain or disease invites immediate attention. But to prescribe merely to relieve your own tension or on the off chance that something useful may happen is poor practice. The end result is likely to be even greater pain and may even prove fatal. At the very least opportunity to treat the disorder properly is gravely impeded. Time, effort, intensive study and consultation with experts and specialists on how best to proceed is a first and crucial part of the treatment itself. Primum non nocereAbove all, don't do damage".

Mr. Chairman, members of the committee:

Both as a working researcher and as a practicing physician my concerns about H.R. 13743 are extremely practical ones.

1. Will the proposed legislation enable me to care for patients more (or less) adequately?

2. Will the proposed legislation make possible more (or less) effective research into the causes and treatment of mental disorders? 3. Will the proposed legislation lessen (or increase) the abuse of drugs?

Among the presumed benefits of the bill are:

(a) Patients will not obtain excess amounts of medication by going to more than one physician.

(b) Patients will not be able to obtain drugs as freely from extra-legal sources.

(c) Unscrupulous doctors who dispense drugs to addicts will

be detected.

The State of Massachusetts (section 210A) requires that not only the names and addresses but the height, weight, date of birth, color of eyes, color of hair, et cetera, of those being treated with narcotic drugs be recorded and made available to any agency of government that may require it. However, Massachusetts has not been notable for any decrease in drug usage as a result of this action.

In actuality the fear of police investigation would probably act to discourage those looking for help. Otherwise a patient could simply use a different name with each physician and, unless we turn to fingerprinting each of our patients for Department of Justice files, the bill as it stands is not of benefit.

Present measures already make the indiscriminate prescribing of narcotics by physicians illegal. If doctors are so prescribing drugs it is most unlikely that they are keeping records of such actions. The same is true in respect to the dispensing of such medications.

The disadvantages of the bill on the other hand are much more. weighty. Physicians as a group put their need to serve above all other considerations despite an occasional exception. The best example is the draft law-although I was on military duty in the Second World War, I am still registered and eligible to be redrafted should the need arise even though I am not in any of the Reserve Corps. Only medical persons were and still are subject to this discriminatory draft but there has been no protest because it is obvious that the armed services must have health care despite our personal inconvenience. On the other hand, no group is so intolerant as physicians of what they re

gard as foolish or unnecessary restrictions. For one who must daily make individual life-and-death decisions with full responsibility for what happens, impediments of time and the right of choice are apt to be regarded adversely. To place all physicians in a class with those serving suspended sentences or on parole so that their premises can be entered, their records rifled, their persons subpenaed without judicial authorization is to treat them with less respect than most common criminals. That these powers will not be used often is aside from the point: what is to the point is that being required to register with the Attorney General under this bill gives his agents the right to legally enter and search the premises, the books and the person of the physician without a search warrant. The implied lack of honesty and responsibility is apt to produce antagonism toward the forces of law and order at a time when the welfare of our society requires. close cooperation.

The paperwork connected with medicare and medicaid is barely tolerated because the system is still so eccentric and undependable. It does make possible treatment of patients who otherwise might not receive help so that we are bearing with it. To now add new requirements of record keeping when there is no demonstrated benefit to either patient or physician is unlikely to make either Congressmen supporting the proposal or the Department of Justice wildly popular. The procedure is even of dubious use to the Department of Justice itself and certainly will tend to create an unfavorable image of its functions and methods.

Further, drugs on a Department of Justice abuse list might not be prescribed as frequently as they should because of the extra paperwork involved or, more likely, there would be a tendency to ignore the law-which is of itself a bad thing.

In the area of research opposition to the bill is even more vehement and more explicit. In the course of the last two decades I have been fortunate in having pioneered with two groups of drugs-the tranquilizers and the antidepressants, and I have attached figures which perhaps I could distribute.

Mr. ROGERS. The committee has the chart. (The chart referred to follows:)

In the attached figure is some evidence of how the resident population of mental hospitals has decreased with savings of an estimated $20 billion a year-and more importantly, the saving of billions of hours of human misery.

I can state categorically as one who did a fair amount of the early research, that were the regulations of this bill in existence I would not have proposed the research I did. If I had proposed it, and were I myself on the review board, the probability is that I would have been forced to reject it. Confidence in this bill is badly shaken because it shows an obvious ignorance of how research is actually done. Initially a few patients may be tried on a new drug or an old drug given for a new purpose. Often regular medications are continued at first, cautious trials of raising and lowering dose, use in a variety of circumstances and purely clinical evaluation and intuition are involved. After months of such informal trials a protocol is designed.

More often than not the original protocol is modified as the work proceeds because of the necessities of treatment. Perhaps the second or third protocol is carried to completion and the results are then published. To require that this final protocol, which evolves out of experience with the patients and with the drug, be submitted for approval in advance as the legislation requires is simply impossible because we don't know in advance what it will be.

The delay imposed by requiring that such protocols be approved by the Department of Justice would be stultifying. Local Human Rights