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1930's inspired by Dr. Thomas Parren, Surgeon General of the U.S. Public Health Service. If we are to educate the public, we must have significant research findings with which to do it. Preaching, jailing, and warnings about unsubstantiated dangers will not suffice; the more we have used these approaches, the worse the problem has become. Not only does this bill threaten to stultify clinical research on drugs; it authorizes the Attorney General to carry out education and research programs in such areas as the assessment of dangerous substances and the identification and characterization of substances with potential for abuse. Thus does the Justice Department land foursquare into the province of medical research. We think that if the Justice Department is to engage in research, it should address itself to researchable issues in the field of law enforcement where there is an urgent need of such proportions as to constitute a national emergency. Medical research belongs in the Department of Health, Education, and Welfare, where it has been exercised since the Department's inception, to the extraordinary benefit of the American people and of mankind.
Before leaving the subject, let me also call your attention to the recordkeeping obligation that this bill would impose upon physicians. Some records are essential, of course, but other requirements border on the absurd. For example, the dispensing physician is required to register at each place of his primary practice where he dispenses these substances. That appears to mean that if a doctor sees some patients in his private office, others at the local general hospital, and still others in a community mental health clinic, he will have to keep three sets of records, under three different registration numbers. Such requirements may be justified in respect of certain rarely prescribed drugs, such as morphine, but they quickly become intolerable when applied to everyday drugs such as meprobamate.
Consider, if you will, the hospitals that operate pharmacies which are a "controlled premise" in terms of the legislation. It is difficult. enough to maintain a careful hospital inventory of drugs like morphine by having them carefully checked and counted three times daily by nurses when they change tours of duty. But with meprobamate, there are thousands of tablets to be checked, under several different brand names and mixtures. It would prove a monumental task for physicians to carry out the procedures stipulated by the bill in the case of certain widely used drugs listed in schedules III and IV. We think that ent laws governing the accounting by physicians for these common drugs are sufficient.
For the record, I am appending an official position statement adopted by the trustees of the American Psychiatric Association in December of 1968 regarding the need to separate medical research and practice from law enforcement in combating drug abuse. Let me also state endorsement of the position statement released 7 days ago by the recently formed Committee for Effective Drug Abuse Legislation. A copy of this release is also attached.
On behalf of the American Psychiatric Association, I thank you for this opportunity to present a serious, responsible, and informed point of view. It is becoming painfully clear that the American people must soon pause to undertake a global review of the role plaved increasingly in our society by chemicals that can affect mood, thought, and behavior. In the next 20 years, hundreds of new drugs of this type will
appear. Meanwhile we find them affecting our lives in every facet as foods, enhancers of recreation and relaxation, agents for self-medication, prescription drugs, merchandise for smugglers and the underworld, mechanisms for the expression of rebelliousness, and even sacramental substances in religion, old and new. To the development of such an overview, and of enlightened legislation deriving from it, the American Psychiatric Association pledges full support. Meanwhile, we urge that stopgap legislation be prepared which will relieve some of the existing abuses, such as punitive sanction, severe out of all proportion to the drugtaker's offense, without adding a host of new problems or emasculating the most effective Government agency, the Department of Health, Education, and Welfare, ever to be concerned with research, education, and service in the field of drug abuse. Thank you, Mr. Chairman.
(The material appended to Dr. West's statement follows:)
POSITION STATEMENT ON DRUG ABUSE AND THE NEED TO SEPARATE MEDICAL RESEARCH AND PRACTICE FROM LAW ENFORCEMENT IN COMBATING IT
(This statement was approved by the Council of the American Psychiatric Association on December 13, 1968, upon recommendation of the Association's Task Force on Drug Abuse in Youth)
The rapidly expanding pharmacopea of chemicals that affect mood and be havior presents medicine with both rich resources and grave responsibilities Therapeutically effective substances (among them many sedatives, stimulants, euphoriants, and antianxiety drugs) may be precisely those which, when misused, can induce addiction or gratification leading to the growing problem of abuse. Highly developed scientific skills are required not only to responsibly investigate therapeutic applications of new and old chemicals, their modes of action, and toxicity, but also to determine the causes of drug abuse and methods for its prevention and effective treatment.
The American Psychiatric Association notes with approval the establishment within the National Institute of Mental Health of centers for research in the fields of psychopharmacology, and of narcotic and drug abuse. Increased support for NIMH's clear mission in fostering educational and scientific work in these areas is mandatory and in the public interest.
We oppose administrative or legislative encroachment by enforcement agencies upon tasks appropriately assigned to the Department of Health, Education, and Welfare. This department serves the public interest by collaborating with the health professions to promote scientifically advanced study of all drugs affecting bodily and behavorial functions. Indeed, its intramural and grants programs have fostered advances in research and education which, in both quality and rate of achievement, have led the world. For continuation of a comprehensive and well-coordinated research attack on the causes and consequences of narcotic and other drug abuse, the separation of enforcement and health-related education and research is imperative.
To our alarm and dismay, we have learned that the Department of Justice has developed draft legislation titled the "Omnibus Controlled Dangerous Substance Act" which endows the department-not a health agency-with sweeping power to regulate medical research and practice.
The proposed legislation would arrogate to the Department of Justice authority to decide, with respect to a wide range of drugs in therapeutic use and with a potential for abuse: 1) what is acceptable medical practice; 2) what is acceptable medical research; 3) who is competent to conduct medical and scientific research in the area of narcotics and a wide range of other drugs; and 4) the abuse potential of old and newly discovered substances and the conditions under which they may be used, not only in practice, but for any kind of scientific investigation.
Further, the draft law provides for a program of medical, psychological, and educational research directed by the Department of Justice that would duplicate and compete with authorities and functions now vested in the Department of Health, Education, and Welfare. This Omnibus Controlled Dangerous Substance
Act turns the clock back to the era when physicians and other researchers were discouraged and afraid to undertake programs in treatment and investigation because enforcement authorities seemed to be dictating the practice of medicine. It grants to the Attorney General responsibilities traditionally reserved to the health professions and would arrest the current forward movement of knowledge and practice.
Until April of 1968 the Bureau of Narcotics in the Treasury Department had responsibility for enforcing narcotic laws, while the Bureau of Drug Abuse Control in the Food and Drug Administration had responsibility for enforcing the Drug Abuse Control Amendments of 1965 relating to certain stimulants, sedatives, and psychotomimetics. But neither agency had any responsibility for health and scientific research. In approving their merger and shift to the new Bureau of Narcotics and Dangerous Drugs in the Department of Justice, both the congressmen who were opposed to and who were in favor of the merger were careful to distinguish the law enforcement mission of the new bureau from scientific, medical, and educational functions. They cited the concentration of expertise already present in the Department of Health, Education, and Welfare and clearly expressed concern that major public educational efforts by a prosecuting arm of government would not invite belief and confidence.
We strongly endorse the concept that health research and education remain solely within the province of health agencies, which can more responsibly assess the value and/or the hazards of drugs than legal agencies. Enforcement agencies generate information for research, but authentic investigations can properly be conducted only by those whose primary mission is scientific research, medical care, and education. Further, the medical profession views the individual, whatever his accountability for wrongdoing as a result of drug effects, as having a need and a right to expect relevant treatment and, indeed, all that is implied by this in terms of the doctor-patient relationship. Finally, we believe it clearly incumbent on law enforcement agencies not to distort or retard advances in research, in the delivery of health care, or in the quality of medical practice available to this nation.
The task of the health professions is to deliver technically proficient and responsible health care, to advance special knowledge and expertise and to inform the public of health needs risks, and valid new findings. It is their role to conduct inquiry regarding the therapeutic use of drugs and to work with relevant specialists in the prevention and treatment of the misuse of drugs. This is best done in cooperation with but not under the direction of law enforcement agencies responsible for controlling the manufacture of and traffic in drugs.
Our common purpose is ultimately to prevent individual suffering and the physical, psychological, and social consequences of drug misuse. In achieving this, our nation deserves the best and most expert information, rather than arbitary measures--such as those proposed by the Department of Justice—which would not only interfere with sound medical practice but repress the advancement of health care and scientific knowledge.
[Press release dated Feb. 13, 1970]
COMMITTEE FOR EFFECTIVE DRUG ABUSE LEGISLATION, WASHINGTON, D.C. A committee of prominent professionals including Nobel laureates medical school deans legal authorities, eminent scientists and leading experts in drug abuse throughout the country-announced today in Washington that it will speak out on "serious and tragic flaws" in drug abuse legislation now pending before the Congress.
Including such members as Dana Farnsworth, M.D., Director of Harvard University Health Services; Nobel Laureates Joshua Lederberg and Salvador Luria; Karl Menninger, M.D.; F. C. Redlich, Dean of the Yale Medical School : and members of the National Academy of Sciences, the rapidly expanding group, known as the Committee for Effective Drug Abuse Legislation, will offer Congress the "full cooperation and counsel" of leading medical and legal specialists who are deeply involved in drug abuse prevention.
The chief spokesman for the group is Neil L. Chayet, Lexington, Mass., a Boston attorney and Lecturer in Legal Medicine at Boston and Tufts Universities. Chayet is a member of the Scientific Review Committee of the Center for Narcoties and Drug Abuse of the National Institute of Mental Health.
According to Mr. Chayet, the group is extremely concerned about "the adverse impact of the bill on the practice of medicine, and, more particularly, on research and education in the area of drug abuse.
"The movement marks the first time that so many leading professionals have joined together to help shape national legislation in the field of drug abuse," he added. He listed a series of objections to the Senate-passed bill, now being heard before the House Interstate and Foreign Commerce Committee.
1. The bill places immense burdens on the day-to-day practice of medicine and attempts to regulate substances properly used by millions of law abiding citizens and their physicians. The bill misses the mark of dealing effectively with the epidemic of drug abuse which is of such great public concern.
2. The initial and final judgment as to whether to restrict an old, current or new compound lies solely in the hands of the Attorney General, regardless of the information provided by the scientific and medical community, which is relegated to a week, advisory position.
3. The criteria for placing restrictions and controls on drugs are stated in terms of "medical usefulness" and "potential for abuse," rather than dangerousness of the substance as far as the individual and society are concerned. The result is that once again, marijuana is classified in the same schedule as heroin; minor tranquilizers are classified along with truly dangerous substances; and very dangerous drugs, such as the amphetamines and short-acting barbiturates are classified as mild substances.
4. The bill calls for mandatory federal registration of all persons and institutions dispensing drugs, whether for research or treatment purposes. Again, the Attorney General, rather than a representative of the scientific community, has the final say on whether a researcher who wants to do bona fide research with methadone, for example, can proceed.
5. The record-keeping and inspection provisions of the bill place an enormous burden on the hundreds of thousands of physicians, researchers and scientists who must use these drug daily in both treatment and reearch, and the bill gives broad regulatory power to the Attorney General relative to inspecting the private and confidential patient records of physicians throughout the United States. 6. The bill gives broad research and education responsibilities to the Attorney General and the Department of Justice in areas other than law enforcement. This represents a serious potential dilution of the research and education effort, and the distinct possibility that the role of the health and education agencies will be lessened and confused.
7. The bill sets up machinery which permits a law enforcement officer to enter a private dwelling, laboratory, or physicians office or home without warning, a provision which could endanger the innocent.
Chayet added that the group has joined together to call attention to the generally overlooked facts of the legislation and to express concern over its sweeping implications.
The chairman of the group is Dr. Jonathan O. Cole, former chief of the Psychopharmacology Research Branch of the National Institute of Mental Health, and presently superintendent of the Boston State Hospital. Dr. Cole called attention to the fact that law enforcement agencies can perform extremely valuable services in the area of drug abuse, but they should not be in "a position" of absolute power when it comes to making such sensitive decisions as registering researchers and classifying dangerous substances.
"The bill as presently drafted will hamper research and retard the development of valuable new treatment modalities at a time when they are so obviously badly needed," he added.
Dr. Daniel X. Freedman, Chairman of the Department of Psychiatry at the University of Chicago and Chairman of the American Psychiatric Task Force on Drug Abuse, stated:
"It is tragic that this legislation is politicizing an area so important to our entire society. Affected by such legislation would be those seeking sorely needed knowledge about drugs and their abuse, and the victims of illicit drug use. Also affected are perhaps a third of all useful drugs which patients require from their physicians.
"The effect will be to create a huge and cumbersome bureaucracy within the Department of Justice with the capacity of exerting serious and unwarranted controls over research and the legitimate practice of medicine."
Dr. Freedman concluded: "This package has been labeled a law enforcement and crime bill, but it emerges as the total regulation of a major segment of the nation's health care."
Members of the group as of February 13 are as follows:
James A. Bain, Ph. D., President, American Society of Pharmacology and Experimental Therapeutics.
Larry Alan Baer, M.D., Commission Addiction Services Agency, New York City.
Richard Brotman, Ph. D., Professor of Psychiatry, New York Medical College.
Jonathan O. Cole, M.D., Superintendent, Boston State Hospital, Former Chief, Psychopharmacology, Research Branch of the National Institute of Mental
Vincent P. Dole, M.D., Professor, Rockefeller University.
Edward F. Domino, M.D., Professor of Pharmacology, University of Michigan. Joel Elkes, M.D., Professor and Chairman of Psychiatry, Johns Hopkins Medical School.
Sydney Ellis, Ph. D., Professor and Chairman, Department of Pharmacology and
Dana Farnsworth, M.D., Director, Harvard University Health Services.
Louis Goodman, M.D., Professor and Chairman, Department of Pharmacology,
John D. Griffith, M.D., Associate Professor of Psychiatry, Vanderbilt University, Nashville, Tennessee.
Mike Gorman, Executive Director, National Committee Against Mental Illness, Washington, D.C.
David Hamburg, M.D., Executive Head, Department of Psychiatry, Stanford University.
Jerome H. Jaffee, M.D., Director, Drug Abuse Program, University of Chicago.
Herbert D. Kleber, M.D., Director, Drug Dependent Unit, Connecticut Mental Health Center.
Nathan Kline, M.D., Director, Research Center, Rockland State Hospital, New York.
Conan Kornetsky, Ph. D., Member, Council of Psychopharmacology Division, American Psychological Association.
Harry Kalven, Professor of Law, University of Chicago.
Joshua Lederberg, Ph. D. (Nobel Laureate), Director, Kennedy Laboratories for Molecular Medicine, Stanford University.
Robert B. Livingston, M.D., Professor and Chairman, Department of Neurosciences, University of California, San Diego.
Salvador Luria, M.D. (Nobel Laureate), Sedgwick Professor of Biology, Massachusetts Institute of Technology.
Arnold Mandell, M.D., Professor and Head of Department of Psychiatry, University of California, San Diego.
Francis de Mayneffe, M.D., Director, McLean Hospital, Belmont, Massachusetts. Karl Menninger, M.D., Menninger Clinic, Topeka, Kansas.
Roger E. Meyer, M.D., Boston University, Former Chief, Center for Studies of Narcotics and Drug Abuse, National Institute of Mental Health.
Neil Miller, M.D., Member, National Academy of Sciences and Professor, Rockefeller University.
Norval R. Morris, J.D., Professor and Co-Director, Center for Studies in Criminal Law, University of Chicago.
William McIsaac, M.D., Ph. D., Director, Texas Research Institute for Mental Sciences, Houston.
Helen Nowlis, Ph. D., Research Consultant for Student Affairs, University of Rochester, New York.
John A. Oates, M.D., Professor of Pharmacology and Medicine, Vanderbilt University.
John A. O'Donnell, Chief, Social Science Section, Addiction Research Center, Lexington, Ky.