VI RESEARCH

Throughout this Report, we have pointed out numerous gaps in knowledge about the causes, consequences and control of drug-using behavior. On the basis of what is known, the Commission has made certain fundamental policy recommendations. At the same time, we have had to tailor some of these recommendations to fit what is not known as well as what is known about drug use. While research cannot answer all the questions, much more information is urgently needed, not only tó develop more rational policy for the future, but also to implement effectively the policies we now have.

A NEW INTEREST IN RESEARCH

The federal government will spend $73.8 million on drug-related research in FY 1973, an increase of 400% over a four-year period. (See Table IV-9) This commitment to research, covering many phases of drug-using behavior and social control, reflects a significant change in official policy. For many years, research into the effects of prohibited drugs and into the behavior of their users was viewed as an attempt to question and subvert government policy. In addition, the aura of criminality surrounding drug-using behavior and the overly rigid protocol requirements often made this area unattractive to researchers. When the behavioral sciences emerged from their infancy during the last 20 years, and researchers became anxious to study drug-using behavior, they were often hindered by the law enforcement community (Lindesmith, 1965) . The net result is that drug consumption was long identified as a subject for medical research only.

Since World War II, the animal studies necessary to serve as a basis for human trial of new psychoactive drugs have been confined largely to a few university laboratories, the most notable of which is the monkey colony in the Department of Pharmacology at the University of Michigan. Inquiry into the effects of psychoactive drugs in man has been designed primarily to examine the pharmacological effects of various doses. The federal government did establish an addiction research center at its hospital in Lexington, Kentucky, often using federal volunteer drug offenders as subjects for drug dependence experimentation. But this research, too, occurred in a laboratory setting. With a few notable exceptions, the government had little interest in systematic studies of what happened when people used the drugs in a social setting.
This narrow focus of drug research has probably had a distorting effect on drug policy. Researchers could tell policy makers much about the chemical and pharmacological effects of various drugs in both animals and man. However, information about the consequences of use in social surroundings came mainly from anecdotes and impressions, sometimes exaggerated and rarely backed by reputable scientific data (King, 1972).
At last, this has begun to change. With the significant increase in drug use during the 1960's, the government recognized the need for information which could come only from expanded research efforts. Prohibited drugs have been made available. for legitimate research; confidentiality has been extended to research subjects; and now, public resources are being devoted to this important area.

THE NEED FOR A DIRECTED RESEARCH PLAN

One major impediment remains. Federal research funds are allocated by nine different agencies, according to their own interests or those of prospective contractors. At the present time, there is no comprehensive directed research plan. The Commission commends the initial research efforts undertaken by SAODAP, in conjunction with the National Institute of Mental Health, in such areas as drug antagonists and longer-acting maintenance agents. But this is not enough; a much larger directed research program is vital.
Even a partial listing of the unanswered questions is startling. We do not know : why people choose to use drugs in spite of criminal laws against use 'and obvious dangers of dependence and disruption; why some individuals who use drugs with high dependence liability become. dependent, and others do not; why some populations seem much more susceptible to use or to dependence than others; what social forces precipitate the periodic "epidemics" of drug use and what causes the lulls between these increases; how drug law enforcement operates and what effect it has on use and distribution; how, in terms of effectiveness, the various treatment modalities compare and why each seems to work well for some users, and not at all for others ; what is the impact of information on the decision to use or not use drugs. We do not even know the incidence or prevalence of various patterns of drug use, including heroin, though this knowledge is indispensable to sensible planning.
The Commission recommends that SAODAP now, and the Single Agency, when and if it is created, receive sufficient funds to design and direct an extended program of research covering all studies touching on drug use. The Department of Health, Education and Welfare should participate in the design of the research plan to avoid overlap and maximize the cost effectiveness of federal research efforts. The research design itself should deal not only with the immediate information needed but also with requirements of future and long-term policy making. It should fund not only projects which produce quick results, but also those, so often overlooked, requiring several years to generate useful data.
The importance of designing and publicizing a comprehensive research plan as soon as possible cannot be overstated. The scientific community must know which areas the government specifically wants explored. All too often, government research contracts go begging for want of qualified researchers. Ry publishing the research plan and demonstrating its long-range commitment, the federal government will draw greater numbers of responsible scientists to the field. Further, this approach will give researchers a status comparable to other drug programs and enhance public understanding of the relationship between information and policy.
In urging a directed plan of research, the Commission cautions against research that points in only one direction. In the past, government agencies have sometimes used drug research to support policy rather than shape it. Studies that produced the answers they wanted were promoted and publicized; projects which appeared to document the "wrong" results were quietly buried and not released. The proposed research plan should specifically include studies that examine without bias alternate hypotheses and approaches.
In addition, the Commission recommends that some money should be available for non-directed research projects not included in the plan. These should be handled separately from the directed research, but coordinated with such plan to avoid duplication of effort. As part of this effort, SAODAP or the Single Agency should continually monitor all reports of independent research in the biological, behavioral, or social sciences, for further leads in understanding drug-taking behavior.
Finally, the Commission recommends that the Government remove legal and bureaucratic obstacles to research into the possible therapeutic uses of currently prohibited substances, such as marihuana and the hallucinogens.
This Report has repeatedly touched upon those aspects of the drug landscape where more information is needed. The Commission believes that research in the following areas is particularly urgent, and should receive high priority.

Incidence, Frequency, and Intensity of Drug Use
At the present time, we have no firm knowledge of the number of people who use various drugs, or the incidence of different drug-using behavior patterns. Even in the area where concern and curiosity have been greatest, heroin use and dependence, the estimates rely on questionable- extrapolation, based on tenuous hypotheses, from elusive data (Blumstein et al., 1973).
Planners and implementers of policy must know what drug use patterns exist, nationally and locally, in order to allocate resources in a rational manner. Too often prevention, treatment and enforcement programs are geared to impressions and suppositions rather than information and actual needs. The Commission recommends a continuing series of projects similar to the two Commission-sponsored National Surveys, as well as other studies, to provide a longitudinal data base on public attitudes and drug-taking behavior.

Etiology and Consequences of Drug Use
Despite 75 years of concern about the "opium problem," fundamental questions about the causes of the problem and its social consequences remain unanswered. To answer these questions, researchers will have to move out of the clinics and laboratories and on to the streets and campuses. Equally important, a multi-disciplinary approach to research must be developed. Not only must there be a division of research projects among the varying disciplines—medicine, sociology. psychology, law and others—but also interdisciplinary research within individual projects. Studies should employ not only different knowledge bases but also different analytical perspectives.
The Commission recommends that etiological research focus on populations exhibiting low, as well as high, incidence of use. It is of equal importance for policy purposes to examine and understand those groups who explicitly disavow drug use and faithfully abide by this norm. Techniques, such as meditation, which have been employed as alternatives to drug use, should also be studied.
The Commission also strongly urges more basic clinical research. We have stressed non-clinical studies because they have so long been neglected, but clinical projects remain vital to improving the understanding of drug dependence and its prevention and treatment. We take particular note of the Addiction Research Center in Lexington which for 35 years has been one of the most valuable single sources of new information in the field of drug dependence. Since its opening this unit has made a series of major contributions, including:
1. The first quantitative techniques for characterization of drug dependence of morphine type.
2. The first definitive description of the syndrome of barbiturate withdrawal. The present method of barbiturate withdrawal is based on this work by Isbell and the Lexington group dating back to 1950.
3. Basic studies leading to the introduction of Nalline as treatment for overdose of the morphine type.
4. The introduction of methadone as a withdrawal drug. It was this contribution which opened the way for the subsequent development of methadone as a maintenance drug.
5. The introduction of opiate antagonists as treatment.
6. The important work on the definition and delineation of the drug dependent syndromes associated with LSD, cannabis and the amphetamines.
7. Most recently, the first objective demonstration of a protracted abstinence syndrome in morphine dependence. This may help explain why relapse is so common after brief treatment.
There is a real need for a stable, ongoing research facility at the federal level, and the Commission recommends continued support of the NIMH Addiction Research Center at Lexington.

The Role of the Criminal Justice System

We have already pointed out the need for systematic evaluation of how well the law enforcement system performs the tasks assigned to it. It is also necessary to determine what actual effect law enforcement has on the distribution and use of drugs outside legitimate channels. Cost-benefit studies of drug trafficking and possession laws are required to determine the appropriate level and scope of their enforcement. In particular, attention should be devoted to the deterrent effect of the possession laws, in order to resolve the persistent debate about their usefulness.
The Commission especially recommends an examination of how well drug offenders perform while on conditional release, including bail, parole, probation and treatment, so that the criminal justice system can better design and implement diversion programs. Also of importance are studies to determine the effect of incarceration for drug offenses on users, especially young users and first offenders. Ideally, such studies would be integrated into a much larger project examining the impact of criminal punishment upon the law violator.

Efficacy of Treatment

To date, evaluation of drug treatment programs has tended to focus on how well patients perform in the program itself, though even here appropriate criteria have not been developed. Except for treatment designed to last indefinitely, such as a long-term maintenance program or an ongoing drug-free community, these evaluations have limited meaning. The Commission recommends that government agencies conduct longitudinal studies of persons who have completed treatment, comparing them to those who left treatment programs before completion and those who never entered treatment. The National Institute of Mental Health is conducting perhaps the first study of this kind with respect to participants in the federal Narcotic Addict Rehabilitation program. The study looks at some subjects accepted by NARA and some rejected; researchers have interviewed a sample, of more than 1,000 persons, gathering considerable information about their lives before and after contact with the federal treatment. program. The Commission commends this effort and urges the federal government to fund more studies like it.
In the context of research on drug treatment, one area which raises many difficult issues is heroin maintenance. In an earlier section of this Chapter, we have already reviewed the arguments for and against heroin maintenance and concluded that such a treatment program, at this time, is inadvisable. Such a program, however, should receive consideration if current methods of containing or reducing the dependent population do not succeed, and the social costs of the present system remain high or grow higher. As an aid to continuing reexamination of this issue, the Commission recommends that the dynamics and consequences of systems in other countries where heroin is freely available, be systematically studied. -
Careful scrutiny of the situation in Thailand and Hong Kong, where heroin is cheap and readily available, could tell us much about the social functioning of dependent persons and enable us to study the physiological and psychological consequences of prolonged use in humans, about which we still know very little. The federal government should sponsor a continuous and systematic examination of the heroin maintenance program in (great Britain, not only to find out how well it has worked there, but also to determine. in what way the British experience would apply to tire. American situation, and what ways it would not.

Other Areas
The Commission recommends study of the synergistic effects of various psychoactive substances currently used, whether licitly or illicitly. In particular, the National Institute of Alcohol Abuse and Alcoholism should perform ongoing research into the effects of taking alcohol with other drugs, since alcohol is legally available and often used this way.
We also recommend that the effects of drug use on driving continue to be studied. For both research and traffic safety purposes, simple and quick methods for detecting presence of drugs in the body must be refined. With respect to some substances, such as the hallucinogens and cannabis, there is no effective means of detection.
For lack of good screening devices, drug driving research in the past has too often relied upon driver records, medical records and questionnaires. Each of these has its inadequacies, and investigators, if they employ them, should use more than one source in order to increase the validity of their data.
The Commission recommends that the federal government provide technical assistance and necessary funding to establish a uniform reporting system, together with necessary laboratory support, on drug morbidity and mortality statistics. The current absence of reliable and comparable data in this area has left serious gaps in effective planning with respect to prevention, treatment and control. We recognize that upgrading these statistics may require considerable expenditures to expand toxicology laboratories, train local medical examiners and coroners, and hire more professional medical examiners. The need for an improved and professionalized coroner system, however, goes far beyond the need for better drug morbidity figures.
Finally, the Commission notes that, while many legal obstacles to drug research have been removed, others remain. Registration, record-keeping, and security requirements under the Federal Controlled Substances Act are not unreasonable, and with respect to substances tested under Schedules II, III, IV or V there does not seem to be any substantial inhibitions to research. For substances under Schedule I, including heroin, LSI), marihuana and tetrahydrocannabinols, the process of obtaining research authorization can be slow and burdensome.
This results not from specific restrictions on research in the Controlled Substances laws themselves, but from the discretion state and federal agencies have in approving projects. To conduct research on a Schedule I drug, the investigator must obtain separate authorizations from state and federal agencies. At the federal level, the law empowers the Secretary of Health, Education, and Welfare, through officials in the National Institute of Mental Health, to review the merits of the research protocol.
A number of researchers have complained about these procedures. Both state and federal agencies, reportedly, are sometimes slow in handling requests. The drugs themselves are difficult to obtain, again allegedly because of bureaucratic red tape. Some investigators have also contended that their proposals are scrutinized much more closely than is usually the case with research approval agencies, and that protocols are often rejected for trivial reasons. Others have reported security requirements so expensive that their projects became impractical.61
The Commission repeats its conclusion that the need for drug research is urgent, particularly with respect to the Schedule I substances. Government agencies should expedite requests for authorization, and attempt to facilitate rather than impede such research. If the investigator meets the standard of professional competence expected of the reputable scientific community and possesses the personal integrity required for security, approval should be speedily given and the necessary drugs made available.

°; From written questionnaires sent to researchers in a study conducted for the Committee for Effective Drug Abuse Legislation (Unpublished, 1972) .