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from through out the country who are greatly concerned about the bills which are being heard here today; I have appended to my statement a list of the members of the Committee. I wish to make it clear that I speak as an individual rather than as a representative of the Committee, or the academic institutions on whose faculties I serve, or the Narcotic Additions and Drug Abuse Review Committee of the National Institute of Mental Health.
My remarks will be primarily restricted to H.R. 13743, although I will allude from time to time to H.R. 11701, also pending before this Committee, and to S. 3246, which, as amended, recently passed the Senate.
H.R. 13743, which most nearly approximate the Senate-passed Administration Bill represents a major and devastating invasion of the practice of medicine and strips the health professions of meaningful power to deal with one of the major health crises of the decade. The problems presented by drug abuse are problems for both law-enforcement and the health profession; H.R. 13743 relegates the health professions and the Department of Health, Education and Welfare, which supposedly represents these professions and their point of view, to a weak advisory position. Even worse, this is being done with the apparent acquiescence of the Department of Health, Education and Welfare. I was present at the hearings on S. 3246 before the Subcommittee on Health of the Senate Labor and Public Welfare Committee at whch Mr. Creed Black stated that the Department of HEW had "won all the points of the debate between HEW and the Department of Justice." If this is true, I respectfully suggest that there was something radically wrong with the debate. Mr. Finch himself stated publically in Boston last Friday evening, in answering a reporter who questioned him on the pending legislation, that "we can live with the legislation." It is incredible that the head of the Health organ of tihs government can state that he can live with a bill which leaves his agency and the professions it represents devoid of so many powers at a time when the scientific skills which this agency can offer are so urgently needed.
The following is a brief summary of the chief objections which I have with H.R. 13743.
STANDARDS AND SCHEDULES
Title II of the Bill, "entitled Standards and Schedules" gives authority to the Attorney General to control dangerous substances. In addition to the power to control substances and assign the manner and strictness with which they are to be controlled, the bill also gives the Attorney General the power to add, delete or to re-schedule a substance as a controlled dangerous substance. Section 201 (a) does require the Attorney General to request the advice of the Secretary of Health, Education and Welfare and from a Scientific Advisory Committee established by the legislation, but the bill makes it clear that the Attorney General is given the final authority.
In making his decision, the Attorney General is to consider such public health and scientific factors such as the relevant potential for abuse, the scientific evidence of its pharmacological effect, what if any danger there is to the public health, and its psychic and physiological dependence liability.
The decision as to how a drug should be classified should remain a scientific and health decision. The opinion of the Secretary of Health, Education and Welfare, acting upon the advice of the Scientific Advisory Committee should be final, with the Attorney General acting in an advisory capacity where it appears that questions involving law enforcement are involved.
CRITERIA FOR SCHEDULING
Section 202 of H.R. 13743 establishes the schedules of controlled substances and the criteria for scheduling such substances. S. 3246 includes marihuana and the opiates as well as the hallucinogens, amphetamines and barbiturates. H.R. 13743 covers only the hallucinogens, amphetamines and barbiturates and excludes marihuana and the opiates, but the statement of criteria for scheduling is identical in both bills.
Section 202 lists four schedules. Schedule I covers those substances which, in the opinion of the Attorney General, possess a (1) high potential for abuse, and (2) no accepted medical uses in the United States and (3) a lack of accepted safety for use under medical supervision. The criteria used in scheduling substances under this bill are improper and inappropriate and lead to illogical results. For example, the clever wording of the above-quoted criteria allows marihuana to be classified in the same schedule as heroin, merely because mari
huana is capable of being abused and at the present time has no accepted medical usefulness. Whatever may be said about the drug marihuana, it is clear that it should not be scheduled and controlled in the same manner as heroin.
Schedule II refers to such drugs as methadone, which have a high potential for abuse, but which also have an accepted medical use.
Schedule III deals with a "potential for abuse less than the substances listed in Schedules I and II" and "a well-documented and approved use in the United States," and "abuse may lead to the medical or the physical dependence or psychological dependence." Included in this category are methamphetamine and the barbiturates. It is difficult to understand how it can be stated that methamphetamines have a "potential for abuse less than marihuana." It is also difficult to understand how it can be said that the barbiturates may lead to moderate or low physical dependence. Lastly, it is difficult to fathom how drugs such as choral hydrate, chlordiazepoxide (Librium) or diazepam (Valium) can be classed in the same schedule with methamphetamine, one of the most abused and deadly of substances.
Schedule IV refers to "substances" with a "low potential for abuse," a clearly accepted medical use, and limited physical or psychological dependence.
A far more rational criteria for control would be one which stressed the element of danger-that is, the danger which a substance poses for the user and the impact of the substance on the individual and on the public health of this nation. This lack of a logical criteria for scheduling is crucial, since the schedule in which a substance is placed is determinative of the penalties for possession and transfer, the restrictions on research with the substance, and the registration, record-keeping and reporting requirements.
Title III of H.R. 13743 deals with the regulation of manufacturers, distributors and dispensers of controlled dangerous substances. Section 302 (a) requires that every person who manufactures, distributes or dispenses any controlled substance in Schedules I, II, III, or IV shall annually obtain a registration issued by the Attorney General. "Dispensing" or "distributing" is defined as the actual giving of a controlled dangerous substance to the ultimate user of the drug. Presumably, the registration requirement would not apply to a doctor who only prescribes the substance, but since most doctors give starter doses to patients, the registration requirement would apply. This requirement should apply only to drugs listed in Schedule I or II, or, if applied to all schedules, physicians who give starter doses of minor tranquilizers, for example, should be exempted from this requirement.
Furthermore, the Attorney General is authorized to inspect the establishment of registrants in accordance with the rules and regulations promulgated by him. Again, this provision misses the mark of the law enforcement effort; there is little question but that the Attorney General ought to be given the right to register and inspect manufacturers of drugs, or even pharmacies, as these are places where large depositories of controlled substances are maintained and which are possible sources of diversion. However, to include the practicing physician or researcher in this category will lead to practices which can be termed little more than harassment and which will certainly be productive of very little in the way of halting substance diversion. The price which is paid is a high one; the doctor's office and presumably the doctor's private patient records would be open to inspection by the law enforcement officials. Any inspection clause which appears in the final legislation should contain language which protects the confidentiality of the physician-patient relationship.
IMPACT ON RESEARCH
One of the most serious faults of H.R. 13743 is that it impinges greatly on scientific research at a time when research involving substances which are being used by millions of Americans is needed. Again, the Attorney General is given the final authority in this area which has traditionally been reserved to the Department of Health, Education and Welfare. For example, registration to dispense a Schedule I substance (including marihuana) in the course of a research project, would have to specifically obtained from the Attorney General. Once again, although the Attorney General is to refer to the Secretary of Health, Education and Welfare for advice, the final decision is made by the Attorney General. The Attorney General (Section 303(f)) may deny a registration on the grounds of "(1) material falsification of any application for registration, (2)
conviction of a felony relating to controlled substances, or (3) revocation of a state license, or on the ground that "the applicant's past practices or proposed procedures furnish ground for the belief that the applicant will abuse or unlawfully transfer such substances or fail to safeguard adequately his supply of such substances against diversion from medical and scientific use."
This means that the Attorney General would be reviewing all research protocols dealing with all Schedule I substances.
The Bill does provide that the Attorney General must register persons to dispense substances in Schedules II-IV if they are authorized to dispense these substances under the laws of the state in which they practice. Most physicians would qualify for registration, although the position of Ph. D. researchers who wish to use these substances in the course of their research (even animal research) is not clear. One possible reading of the Bill would force such researchers to prove their case by showing that the issuance of a registration to such a person would not be inconsistent with the public interest."
ESTABLISHMENT OF QUOTAS
Section 306 of H.R. 13743 gives to the Attorney General the power to determine the total quantity and production quotas for substances in Schedules I and II "to be manufactured in each calendar year to provide for the estimated medical, scientific and industrial needs of the United States. Once again, the decisionmaking power is misplaced; certainly the Department of Health, Education and Welfare is in a better position to assess the "medical, scientific and industrial needs" of the United States than is the Attorney General. The power to enforce and control the quotas once established should belong to the Attorney General, but the establishing of the quotas should be handled in the Department of Health, Education and Welfare, with appropriate consultation with the Attorney General, if a peculiar law enforcement problem is presented.
RECORD-KEEPING AND REPORTING
The record-keeping and reporting provisions of the legislation provide further confusion. The first portion of Section 307 requires the making of a complete record of all controlled substances on hand, and the maintenance of these records for a period of two years. The last sentence of the section, however, states that this requirement does not apply to practitioners or researchers who lawfully prescribe or administer substances in Schedules II, III, or IV; yet; in paragraph (b) (1) which follows the above section states that "such practitioner must comply with the requirement of Section 307 of this Act", which section has just said that practitioners need not comply. This language should be clarified so as to make it clear that legitimate practitioners or researchers need not comply with these record-keeping procedures.
RESEARCH AND EDUCATION
I note that Section 602 (a) authorizes and directs the Attorney General to carry out "educational and research programs", including the accurate assessment of controlled dangerous substances and identification and characterization of controlled dangerous substances with potential for abuse. I submit that this section presents a potentially dangerous dilution of the government sponsored research effort, and that the primary responsibility for research involving the controlled substances should remain with the Department of Health, Education and Welfare, and that research and educational programs of the Department of Justice should be limited to operational and law enforcement aspects.
One of the most unfortunate provisions of the Bill, offensive to the scientific community as well as to every private citizen is Section 702 (b). This section provides that "any officer authorized to execute a search warrant relating to offenses involving controlled dangerous substances the penalty for which is imprisonment for more than one year may, without notice of his authority and purpose, break open an outer or inner door or window of a building, or any part of the building, or anything therein, if the judge is satisfied that there is probable cause to believe that if such notice were to be given the property sought in the case will be easily and quickly destroyed or disposed of.
This provision, commonly referred to as the "no-knock" provision would allow a police officer to enter a private dwelling without notice if the judge issuing the warrant is satisfied that the evidence sought may be easily and quickly disposed of. This violates what has always been one of our most basic freedoms-the freedom to remain undisturbed in the sanctity of our homes. The Fourth Amendment of the Constitution provides that
"The right of the people to be secure in their persons, houses, papers, and effects against unreasonable searches and seizures, shall not be violated, and no warrants shall issue, but upon probable cause, supported by oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized."
The provision applies to the physician's office, home and the scientists' laboratory as well as to the pusher. Without this device, large amounts of controlled substances would not be able to be destroyed, as under present law, an officer with a search warrant can probably force entry immediately after he identified himself. All that may be lost are very small quantities of controlled substances, which may be lost even if the officer enters unannounced, and the sacrifice of the right of privacy of all citizens seems disproportionate to what is to be gained. I urge that this provision be deleted from the pending legislation.
Drug abuse poses two clearly distinct problems, which must be quickly and effectively approached. These are (1) the problem in the sphere of health, education and research, and (2) the problems in the sphere of law enforcement. H.R. 13743 confuses these two and, hopefully, will be amended to permit the health, education and research functions to be exercised by that agency which is established for this purpose. Appendix A, attached to this statement, contains suggested amendatory laws.
There are of course many possible ways to amend the pending legislation. One is to look to a bill such as H.R. 11701, which amends the Public Health Service Act, the Community Mental Health Centers Act and the Internal Revenue Code. While there are many good things which may be said about this bill and while it maintains significant powers in the Department of Health, Education and Welfare, I have selected the device of suggesting amendments to H.R. 13743, in the event that this bill or its Senate equivalent continues to receive dominent consideration. Section 201 is hereby amended by striking the section and substituting the following:
(a) The Attorney General shall control all substances enumerated in Section 202 of this Act. The Secretary of HEW, may pursuant to the procedures of subchapter II of Chapter 5 of Title V of the United States Code, add, delete or reschedule a substance as a controlled dangerous substance. Before so doing, the Secretary of HEW shall request the advice in writing from the Attorney General and from the Scientific Advisory Committee established in Title VI of this Act whether a substance should be added, deleted, or rescheduled as a controlled dangerous substance. Such advice shall be rendered to the Secretary of Health, Education and Welfare within a reasonable time. The Secretary of Health, Education and Welfare shall consider with respect to each substance hereafter controlled:
(No change in (1) through (8).)
(b) If the Secretary of Health, Education and Welfare designates a substance as an immediate precursor, substances which are precursors of the controlled precursor shall not be subject to control solely because they are precursors of the controlled precursor.
(c) When it appears to the Attorney General that a substance not controlled under this section is being significantly abused, such information shall be forwarded to the Secretary of Health, Education and Welfare who may request the advice of the Scientific Advisory Committee prior to determining whether or not to control such substance. The Secretary of Health, Education and Welfare shall make such determination on whether or not to control the substance within a period of 60 days from receipt of the information from the Attorney General.
(Section (d) is hereby deleted.)
SCHEDULES OF CONTROLLED SUBSTANCES
Section 202 (first paragraph unchanged).
(a) Schedule I-In determining that a substance comes within this schedule. the Secretary of Health, Education and Welfare shall find:
(1) a very high potential for abuse, and
(2) serious danger to the public health and to the individual user,
(3) no accepted medical use in the United States, provided, however, that no substance will be classified within this schedule solely on the basis that no accepted medical use is currently known.
(On the basis of current medical knowledge, substances such as heroin and LSD would be included in this Schedule)
(b) Schedule II-In determining that a substance comes within this schedule, the Secretary of Health, Education and Welfare shall find :
(1) a high potential for abuse,
(2) moderate danger to the public health and to the individual user. (Drugs such as morphine, methadone, and methamphetamine might well be classified within this schedule in accordance with present knowledge about these substances.)
(c) Schedule III-In determining that a substance comes within this schedule, the Secretary of Health, Education and Welfare shall find:
(1) a potential for abuse less than the substances listed in Schedules I and II, and,
(2) danger to the public health and to the individual user less than substances classified in Schedules I and II.
(Substances such as chloral hydrate, or phenobarbital might well be classified under this schedule on the basis of current knowledge.)
(d) Schedule IV-In determining that a substance comes within this schedule, the Secretary of Health, Education and Welfare shall find:
(1) a low potential for abuse relative to the substances listed in Schedule III; and
(2) a sufficient danger to the public health and to the individual user to warrant control under this schedule.
(e) The Secretary of Health, Education, and Welfare may by regulation exempt any compound mixture or preparation containing drugs controlled under this Act if in his judgment the compound, mixture or preparation is not and will not be subject to significant abuse: The Secretary of Health, Education, and Welfare may by regulation exempt any substance from control under this Act if such substance may under the provisions of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.) be lawfully sold over the counter without a prescription.
RULES AND REGULATIONS
Section 301 is deleted and replaced by the following:
SEC. 301. The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of the manufacture and distribution of controlled dangerous substances. The Secretary of Health, Education, and Welfare is authorized to promulgate rules and regulations relating to dispensing controlled dangerous substances.
Section 302 (d) is amended by adding the following sentence: "Provided, however, that nothing contained in this section shall authorize the Attorney General to inspect patient records or force other disclosures which would violate the confidentiality of the physician-patient relationship."
Section 302 (a) is amended by striking the present section and inserting in place thereof the following:
"Every person who manufactures or distributes any controlled dangerous substance, or who proposes to engage in the manufacture or distribution of any controlled dangerous substance, and any person who dispenses substances listed in Schedules I and II, shall annually obtain a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him. Such regulation shall provide that institutions such as accredited medical schools, hospitals or research institutes may obtain a registration which covers duly authorized investigators doing animal and laboratory research with controlled