Sign the Resolution for a Federal Commission on Drug Policy
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Drug Use in America, Problem in Perspective
Commissioned by President Richard M. Nixon, March, 1972
Chapter 4 - Toward a Coherent Social Policy
I. THE AVAILABILITY DECISION
(Editors note: The following paragraph appears exactly as printed on pages 208-209 of the report.)
Having defined both the problem and the overall social policy objectives in terms of behavior, rather than in terms of specific drugs, the policy-making process in its third step must determine the cond-iuse and the individual's right to autonomy because restrictions on available. This part, of the process does not involve a direct conflict between society's right, to protect itself from the consequences of widespread use, and the individual's right to autonomy because restrictions on availability do not intrude into the realm of private behavior, but merely the individual's options. Accordingly, society may legitimately emphasize control, since the difficulty of retreating from widespread availability, once, established, argues for a cautious approach. Policy makers may legitimately speculate about the aggregate consequences of use and should not be deterred from restrictive control by the inadequacy of available information regarding the effects of a particular substance.
MODELS OF AVAILABILITY
On one public policy issue regarding drug use, there can be little dispute: if drugs are not available, people will not use them. The converse may not always be true, but the Commission notes that the incidence of use of potent psychoactive, substances does appear to bear general relationship to how readily available they are.
Through its legal system, a nation can attempt to eliminate the availability of a particular drug, or to channel its distribution in specified ways. Once the legal market has been established, a multitude of variables, including the customary habits of the population and economic incentives for illegal trafficking, will determine whether the drug is available only within that market. Therefore, the major question about decisions to restrict availability through law is not whether it will have an effect on supply of the substance, which it surely will, but rather how much effect it will have.
There are four alternative models of availability for psychoactive substances. The first involves no special controls at all: the substance is treated in the same way as other market, commodities. Under the second approach, the substance is subject to special controls, but remains lawfully available for self-defined purposes. The third model limits availability to specific purposes; generally, to medical and research uses only. Under the fourth approach, the, substance is not legally available at all, except perhaps for narrowly-circumscribed use in research (McGrew, 1973).
Within the three models of controlled availability, the level of control may range from minimum to strict according to the types of restrictions imposed and the, rigor with which they are applied. Among the most common restrictions are:
THE CALCULUS: AN OVERVIEW
Relative Social Cost
The availability decision, since it deals with supply is necessarily drug specific; consequently. the decisional process starts with the relative social cost of particular substances. In Chapter Three, we defined social cost as the aggregate impact on the public safety, health and welfare of drug-induced behavior and drug-dependence. Actual social cost refers to this impact within the present social context, including present conditions of availability. Maximum social cost refers to the projected impact under conditions of unrestrained availability.1
1 We remind the reader that we excited from the social cost analysis the nonbehavioral risk of drug use. The adverse effects on individual health, which generally attend repeated use of some drugs, are not matters of societal self protection. Some health risks may be matters of self-protection, such as communicable diseases and risks which the individual would not choose to run were he aware of them. However, the public interest in precluding, as opposed to informing, individual choice to use a particular substance is substantially different when the drug, whatever its risk potential or dependence liability, exerts no significant impact on behavior.
The cost associated with a particular drug defines generally what it is worth to society to prevent or reduce its use by means of control. Wherever any significant social cost is attributable to use of a substance, there is at least tentative justification for restricting its availability, the higher the cost, the greater the justification. Similarly, unless significant social cost follows from use of a given drug, there is no rational basis for precluding its availability for self-defined purposes.
If the properties of specific drugs were the only determinant of availability decisions, controls would be most restrictive for alcohol, opiates, and cocaine and relatively less restrictive for marihuana and the hallucinogens. But more is involved in addition to the relative social cost of various substances, the policy maker must examine the efficacy of various control devices in channeling use toward approved purposes, the cost of the counters and finally, the importance of the availability decision as a symbol of control.
Efficacy of Controls
The effectiveness of particulate control devices in reducing availability of substances for disapproved uses involves two factors: how well counters prevent legitimately produced substances from being diverted into unintended channels and how well they prevent illegal production and distribution. Controls have generally succeeded in the first task, which is to ensure that lawfully produced -drugs go to lawful uses, though sometimes they have had the undesirable effect of inhibiting distribution for approved purposes (McGrew, 1973).
Success of controls in forbidding illegal production and supply has been more problematic. Drug trafficking laws are difficult to enforce for a number of reasons. First, there are practical and legal obstacles to the detection and proof of any drug-related crime, deriving from the lack of complaining witnesses to the offense. Second, most psychoactive drugs can be obtained abroad or produced domestically with relative ease, while they can be detected only with great difficulty even when transported in economically profitable quantities (General Accounting Office, 1972). Third, it is not easy for law enforcement agents to penetrate the illegal market (Moore, 1970). Part of the distribution network may lie in foreign countries, whose authorities are reluctant or unable to cooperate; even in this country, populations in some areas where dependence is high are not always willing to assist enforcement agencies. Finally, and most important, is the economic attractiveness of the trade in illicit drugs. Rewards for dealing are a function of drug demand, and as long as there is a demand for substances outside the prescribed channels of availability, society will never lack persons to supply it.
Cost of Controls
The utility of controls, of course, rests not only on their effectiveness but also on their cost. Most easily quantified are the operating costs: Salaries of administrative and enforcement personnel, agency overhead and equipment costs, expense of prosecution and imprisonment. Other costs are not as readily measured, but they are no less important. For example, controls which prevent diversion of drugs to illicit uses may also interfere with legitimate use, depriving both individuals and society of a benefit.
Drug trafficking laws have other intangible costs, too. When supply for certain uses is prohibited, the illegal market which usually emerges increases the price of the commodity. To the extent that persons are dependent on the prohibited substance and cannot secure it legitimately, property crimes may increase as a direct result of restrictions on availability. Also, the purity and potency of illegally produced drugs are unregulated and unpredictable, aggravating the public health problems attending their use.
One important cost of control has, until now, largely been ignored. If a system of controls succeeds in substantially restricting supply of a particular drug and in frustrating the demand for it, some of that demand may shift to other drugs. There is no net gain if one drug is controlled successfully, only to cause a corresponding rise, in the use of another, with equal or more serious costs. Further, there is no net gain when lawful production is restricted, but replaced with unlawful supply at substantially the same level.
The Social Context of the Availability Decision
The Commission points out again that no decision about drugs can be made in a vacuum. The policy maker must keep constantly in mind that all his projected actions will affect one another and that all will operate within a much larger complex of problems and policies. This is equally true with respect to the, last major factor in the availability decisional process: the social context within which the, decision is made.
In many instances the availability decision is purely anticipatory. One of the important contributions of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substances Act) was to establish a mechanism for making availability decisions before widespread use of a drug and public reaction to it become established. Whenever a decision is being made for a substance already available and being used for self-defined purposes, an additional factor enters the decision-making process; the meaning which the drug has developed for the using and non-using populations.
At the present time, classification of a drug for availability purposes may carry a symbolic value not directly related to either social cost or to utility of control. A decision to loosen controls can connote approval of use, or suggest that the drug in question is not harmful, thereby encouraging experimentation with it. Conversely, tightening controls beyond a given level may be necessary to lend coherence to a social policy which otherwise appears inconsistent.
By referring to these effects as symbolic, the Commission does not discount their importance. On the contrary, we recognize that in any decision for the immediate future these benefits, like the more concrete ones, must be given full weight. Eventually, however, symbolism and fact must join; if they do not, the symbols will lose their meaning, at least for some segments of the population. For this reason, a particular scheme of control should not be retained indefinitely for its symbolic value alone where other, factors point toward less control, concern for the cultural impact of removing restraint will justify retention only long enough to ease the transition.
THE PRESENT SYSTEM
The analysis we have described does not work with mathematical precision. Some of the elements are not even quantifiable in theory, and for many of those that are, there is not sufficient information from which to calculate. Nonetheless, the process accurately describes and properly relates the relevant f actors, and a deliberately preventive bias in the balancing compensates for the lack of information.
Following this approach, the Commission concludes that the present system should be retained, with several adjustments in the control of certain drugs. This decision does not mean that perpetuation of the present system will assure achievement of our policy goals. It signifies only that present controls on availability do seem to result in a net benefit for society: a reduction in social cost of drug use that outweighs the cost of control itself.
There are two caveats even to this limited endorsement. First, in reaching our recommendations, the Commission employed the rule that where the present state of knowledge left an issue in serious doubt, the doubt would be resolved in favor of retaining a restrictive approach. At the availability level, the burden of proof must rest on those who recommend new and untested solutions, particularly measures which might, entail widespread availability of a potent psychoactive drug. The corollary to this rule, however, is that the present system of controls must allow sufficient leeway for the research and experimentation which will expand our knowledge and enable policy makers to reach more, informed decisions in the future. Ignorance of the road ahead may excuse a slow and cautious advance, but when the present situation is unsatisfactory, it cannot excuse standing still.
The second caveat is that, with respect to some drugs, considerable weight had to be given to the symbolic value of control. As we have pointed out, this serves only as a temporary justification. If more direct approaches to the problem of use do not succeed in reducing demand for certain drugs, society in the future must consider alternative methods of regulating their availability.
At present, society controls availability of drugs in a wide variety of ways. (See Table IV-1) For many substances, a previous availability decision can be justified retroactively; for others it cannot. Prior to the Controlled Substances Act, however, it is fair to say that these decisions were reached in an ad hoc manner.
Availability Not Limited As To Purpose of Consumption
There are two major psychoactive substances which are under control but not restricted as to purpose of use: tobacco and alcohol.2 Tobacco is controlled only at a minimal level; warning labels are required, purity is verified and production is supervised for purposes of collecting excise taxes. Distribution to minors is prohibited, although this restriction is rarely enforced. Controls on alcohol are at moderate to minimal level, depending on jurisdiction and type of beverage. Time and place of retail distribution are often restricted, distribution to minors is prohibited, and interstate movement may be regulated. There are no current examples of drugs whose availability, while strictly controlled, is not restricted as to purpose of use. It should be noted, however, that some have proposed such a system for marihuana.
2 The solvents and inhalants-glue, lacquer thinner, ether and nitrous oxide are widely available for non-drug purposes, and, therefore, are not usually restricted in terms of "consumption." Some states and municipalities, however, regulate sale of these substances to minors. Massachusetts, for example, requires minors purchasing glue to write their name in a register kept by the seller for police inspection. Denver, Colorado prohibits by ordinance sale of glue to a person under is, except with parental consent or unless the glue is sold together with a model kit.
1 Schedule I of controlled substances laws.
2 Schedule II of controlled substances laws.
3 Schedules III and IV of controlled substances laws.
4 Schedule V of controlled substances laws or unscheduled and controlled only as prescription drugs.
5 The level of control of medical preparations of the opiates varies according to strength of solution. The table indicates the level of control for the most common formulation of these substances.
6 These substances are controlled as to purity and potency and are subject to labeling requirements.
Availability Limited As To Purpose of Consumption
Most psychoactive substances are so controlled that they are lawfully available only for certain purposes. With the one minor exception of peyote, which is available to the Native American Church for sacramental uses, this means availability is limited to medical and research uses.
Under the purpose-restricted model of availability, drugs controlled at a minimal level are available for a wide range of therapeutic needs, broadly defined and often determined by the individual user himself. For some drugs, prescriptions are not required to obtain the drug, but the user must sometimes indicate that purchase is for medical use. For other minimally controlled drugs, prescriptions are required, although they may be secured with very little difficulty because of generalized medical indications for their use. There are also controls on the purity and potency of these drugs and, occasionally, on the quantity that may be sold to individual consumers. Drugs that are restricted as to purpose and subject to minimal control are generally not covered by federal and state controlled substances laws, but a few, mainly cough syrups and antidiarrhetics containing, codeine and opium, are listed under Schedule V of these laws.
Moderately controlled drugs remain available for therapeutic purposes, but these purposes tend to be more precisely defined; and the propriety of use is always determined by someone other than the user. Prescriptions are uniformly required to obtain the drug, and distributors are required by law to maintain inventory accounting and take precautions against diversion of drugs for illicit use. Security controls are also imposed on manufacturers, and the potency of the, drugs is regulated. There may also be limitations on the amounts that may be dispensed to individual users within a given period of time. Drugs restricted as to purpose and presently controlled at a moderate level include barbiturates, certain non-barbiturate sedatives and some stimulants and analgesics. They are regulated under Schedules III and IV of the controlled substances laws.
Under strict controls, psychoactive substances are available for very limited and narrowly defined therapeutic and research purposes. Manufacture and importation are limited by quota, and tight security controls are imposed on the entire distribution system. A non-refillable prescription is required to obtain the drug, and, in some cases, the drug may be administered only at particular places. Quantities dispensed are also regulated. Strictly controlled psychoactive substances include morphine, methadone., cocaine, amphetamines and some amphetamine-like stimulants. They are listed in Schedule II of the controlled substances laws.
Substances Not Available for Consumption
Availability of a few psychoactive drugs is extremely restricted; they are available only for research under strict controls, which must be specified in the research protocol. Both protocol and researchers must be approved by the government. Cannabis drugs, hallucinogens and certain opiates, such as heroin, are the most important substances in this manner. They are listed in Schedule I of the controlled substances laws.
3 Comprehensive Drug Abuse Prevention and Control Act of 1970, PL, 91-513. 84 Stat. 1236, and the Uniform Controlled Substances Act, approved and recommended for enactment in all States, National Conference of Commissioners, on Uniform State Laws. August 1-7, 1970. The Uniform Act has been adopted in 38 states.
SPECIFIC RECOMMENDATIONS
In recommending retention of the present system of controlling availability, the Commission does not endorse the occasional process which established these controls or ratify the historical precedents which shaped them. While we recognize that history has a legitimate role in our decisions, prior decisions cannot be conclusive. Accordingly, the Commission does not propose confirmation of the present controls without change.
Opiates
Because heroin has a severe dependence liability and capacity for inducing compulsive use, and because it is particularly attractive to highly vulnerable populations, its social cost is considerably out of proportion to the numbers of its users. This reason coupled with strong symbolism attaching to the use of this drug within affected communities, justifies the highest possible restrictions on availability. Accordingly, the Commission favors retention of the present restrictions on the availability of heroin and other opiates.
Controls have thus far been very effective in preventing diversion of lawful supplies of the medically used opiates; for example, morphine, Dilaudid and Demerol (McGrew, 1973). The Commission recognizes, however, that the availability of illicit heroin has, to a large degree, reduced the demand for diversion of lawfully-produced substitutes.
Diversion of methadone supplied through maintenance programs has proved more of a problem. As a result, maintenance programs have been confronted with the conflict between the therapist's need for flexibility in treatment and law enforcement's need for rigid control over availability. To avoid destroying program effectiveness, the Commission recommends that federal and state regulations concerning maintenance programs emphasize treatment flexibility, coupled with reasonable controls to curtail diversion.
The present system has been less effective in preventing importation and distribution of heroin than it has been in suppressing diversion of the legal opiates. While the Commission believes that new enforcement strategies may prove promising- as will be pointed out later in this Chapter, it seems unrealistic to expect substantial reductions in unlawful supply unless major traffickers decide to stop smuggling the drug into this country. It is fair to assume that they will not stop such activities until the demand disappears.
The best hope for reducing the social costs of heroin dependence lies in the prevention and treatment areas. If a concentrated social effort to reduce demand does not have a significant impact over the next few years, policy makers should consider the other models of availability, since present controls operate at considerable cost and with only modest results. At, the present time, however, the Commission strongly advises against any change in present controls on availability of heroin. We will have more to say on this subject in connection with treatment and research.
Cocaine
Cocaine, like heroin, is a drug with high dependence liability and appeals to the same vulnerable populations attracted to heroin use and intravenous amphetamine use (Woods and Downs, 1973). Although the actual social cost stemming from cocaine is not yet substantial, there is some evidence that illicit supply and use of cocaine is increasing. Our National Survey figures support this hypothesis, as do recent seizure statistics. Law enforcement officials several major cities also share the impression that cocaine use is a growing problem.
Within the domestic distribution system, controls against diversion of unlawful cocaine have been very effective. Yet, paradoxically, much of the cocaine smuggled into the country for illicit use may originate from our own lawful production. In 1970, for example, the United States accounted for 88% of the reported world imports of coca leaves, and presumably processed most of the world's lawful cocaine. From the imported raw material, the United States produced 1,033 kilograms of cocaine and exported 725 kilograms. During that year, 379 kilograms were distributed in connection with this country's legitimate use, thereby reducing the total domestic inventories to 248 kilograms. Those countries to whom we exported cocaine apparently reexported a substantial amount of it, resulting in an even greater distribution (International Narcotics Control Board, 1971). It is not implausible that some of the cocaine shipped out of the United States was diverted overseas and smuggled back into this country for illegal distribution.
In the Commission's opinion, on the basis of formal statements from the American Medical Association's Department of Drugs and from the American Association of Ophthalmology, cocaine no longer has significant medical uses not easily served by other substances. The Commission recommends that the American Medical Association survey the medical profession to determine what, if any, unique therapeutic benefits cocaine has. At the same time, the United States, working through the United Nations and the World Health Organization, should encourage worldwide discussions on the therapeutic uses of cocaine and on its dangers.
The Commission further recommends that the federal government, taking into account the AMA survey and the results of the international deliberations, reduce legitimate cocaine production in this country (including import of coca leaves for purposes of extracting cocaine) to the minimum quantities needed for domestic research and medical uses. If no unique therapeutic use of the drug remains, the government should eliminate manufacture altogether. In addition, the United States should work through diplomatic channels to persuade other countries not to manufacture cocaine for export.
Because control of cocaine availability is already strict, the symbolic value of tighter restraint will be slight. Accordingly, the Commission warns against over-dramatizing a change in control and thereby advertising the drug to vulnerable populations not yet familiar.
Amphetamines
Until recently, amphetamines were subject only to moderate control, and they were easily obtainable within the medical system for a number of uses which could have been served by substances with less risk potential. Amphetamines were often prescribed for patients who were overweight or suffering mild depression or fatigue. They were also available through "backyard pharmacies" and loose prescription practices, to persons who felt their daily lives required periodic stimulation. A substantial quantity of these drugs, recently estimated to have been around 20% of lawful production, found its way into illegal distribution channels and could be purchased on the street (Ingersoll. 1972).
Amphetamines have high reinforcement potential, and their repetitive use can lead to seriously disruptive behavior patterns. Moreover, when taken as a replacement for normal sleep and proper nutrition, they can cause serious organic damage. Yet, under the previous system of controls, both the public and the medical profession seemed to underestimate the risks of amphetamine use.
New controls have reduced lawful production of amphetamine drugs to approximately one-tenth their previous level. Though unlawfully produced amphetamines may have replaced diverted drugs in the illicit market, introducing new problems of adulteration and black market prices, rescheduling amphetamines has probably realized a net social gain by reducing their over-prescribing. The Commission urges that the present controls on amphetamines be retained .4
4 The Commission also endorses plans of the Food and Drug Administration to order injectable methamphetamine off the market, together with amphetamine sedative combinations. The FDA found that the injectible form is unsafe and that the combination marketed as anoretic (appetite depressant) drugs were ineffective Food and Drug Administration, 1973).
Barbiturates
Overuse of barbiturates is America's hidden drug problem, comparable perhaps to the scope of hidden opiate dependence around the turn of the century. Medical supervision of the rise of these drugs has too often been lax, resulting in abundant availability of barbiturates within the medical distribution system. In 1970, barbiturates (and the considerably lesser used barbiturate substitutes) accounted for over 25% of the total prescriptions issued for psychoactive drugs. Only the minor tranquilizers, with 38.8%, were, higher. Forty million barbiturate prescriptions were issued in 1971-22 million of them for refills of old prescriptions (Brecher, 1972; Aston. 1973).
Because of their sedative, powers barbiturates have long been important therapeutic agents, but their use, if not closely supervised, can lead to serious problems. Heavy repeated doses result in sustained stupor, and sudden withdrawal from chronic use can be hazardous. Moreover, the danger of an overdose is greater with barbiturates than with any other psychoactive substance. This danger is aggravated when the barbiturate user also drinks, since alcohol and barbiturates potentiate each other's effects on the central nervous system (Aston, 1973).
In addition to the hidden medical use problem, the Commission has found a significant increase in street use of barbiturates in recent years, particularly among adolescents, though accurate statistics do not, exist. Because of both the medical and street problems with barbiturates, a strong argument has emerged that these drugs should be moved to Schedule II control, as the amphetamines have, been.
The Commission agrees that, something must be, done quickly about the misuse of barbiturates, but we have grave doubts whether rescheduling the drugs, as was done with the, amphetamines, will be effective. In the first place, rescheduling is unlikely to have a substantial effect on street use. There is no conclusive evidence that street drugs are being diverted from the manufacturing and wholesaling levels. In his testimony before the Commission in Washington, D.C., on July 19, 1972, John E. Ingersoll, Director of the Federal Bureau of Narcotics and Dangerous Drugs stated:
We have, for many years, attached greatest importance to the amphetamine and barbiturate drugs in the belief that they constitute the principal targets of diversion. Various statements have been made by both private and government authorities that as much as 50% of the total drug production of these substances is diverted into illicit channels.
On the basis of the single scientifically based study which had been made, this appears to have been an exaggeration. Dr. Joseph Greenwood of our Bureau's scientific staff began the first systematic collection and analysis of data for these drugs relating to their distribution for calendar year 1967; and that was prior to the existence of the number of regulatory controls which now exist.
This study . . . has provided some rational basis for our assessments. In accordance with its findings, approximately 20% of the total amphetamines production was unaccounted for and, therefore, presumed to have been diverted.
In contrast, approximately 3.1%, of the barbiturates production was unaccounted for. But here, the equation is somewhat more complex. If we select only the figure which represents the conversion of barbiturate compounds into medical dosage forms, we find the percentage of unaccountability rises to 6.5%.
We may observe, in this connection, that barbiturate compounds as a class are far more diversified than are amphetamines, and many have virtually no history of abuse whatsoever.
Available data indicate that thefts at the retail level and "diversion" front the home, medicine, chests may account for some of the barbiturates on the streets; how much is unclear (Ingersoll, 1972). Rescheduling might curtail youthful experimentation with barbiturates from the family medicine cabinet; otherwise, it should have little effect on street use.
Since the quotas required by Schedule II are a function of medicinal use they will also have no substantive impact on medical availability of barbiturates. Most important, imposing higher controls upon barbiturates would significantly raise their price to lawful users, and could interfere with their legitimate medical uses. For example, barbiturates remain the medical drug of choice for chronic insomnia, a condition which. left untreated, causes a general deterioration in physical and mental health. In addition, they are commonly used to reduce anxiety in cases of peptic u1cer and high blood pressure. Drugs that might substitute for barbiturates are often less effective and present the same kinds of risks. Moreover, the volume of legitimate medical use of barbiturate compounds is so great that rescheduling will place a serious burden on the control mechanism, inevitably weakening administration of controls on the other Schedule II substances (McGrew, 1973).
The only effective step to reduce the hidden barbiturate problem is development of restraints on prescription practices within the medical profession itself. This can be accomplished either by tightening controls and moving the barbiturates into Schedule II or by the American Medical Association's taking the lead and creating prescription guidelines. Either action is likely to impress upon physician and patient the risk potential of these drugs and close the gap between perceived dangers of medical drugs and those of illicit drugs.
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