4
Behavioral Responses and Consent

UNINTENDED BEHAVIORAL CONSEQUENCES

The “law of unintended consequences” demonstrates that promising innovations advanced with the noblest of intent can play out differently than anticipated, and possibly much less well than hoped for (Merton, 1936). Consequently, it can be useful early in the development of an innovation to think about how things might turn out badly. MacCoun (this volume) undertakes such an exercise for immunotherapies and sustained-release formulations for treating drug addiction. He finds that for those inclined to worry, it is not hard to envision a number of potentially negative scenarios.

These potentially negative scenarios can be divided into four types: (1) users’ attempting to swamp or override the therapy with larger doses; (2) substitution of one drug whose effects have been blocked with another drug whose effects have not been blocked; (3) increased incidence or prevalence of drug use because of a perception that there is less risk involved; and (4) aggressive actions of drug sellers who are losing sales to try to move into new markets. This section reviews some of the considerations associated with each of these scenarios.

Users’ Trying to Swamp or Override Treatment

It would be a major boon to treatment if an intervention such as immunotherapy or depot medication made a user completely uninterested in using a drug. Unfortunately, users who are offered these thera-



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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions 4 Behavioral Responses and Consent UNINTENDED BEHAVIORAL CONSEQUENCES The “law of unintended consequences” demonstrates that promising innovations advanced with the noblest of intent can play out differently than anticipated, and possibly much less well than hoped for (Merton, 1936). Consequently, it can be useful early in the development of an innovation to think about how things might turn out badly. MacCoun (this volume) undertakes such an exercise for immunotherapies and sustained-release formulations for treating drug addiction. He finds that for those inclined to worry, it is not hard to envision a number of potentially negative scenarios. These potentially negative scenarios can be divided into four types: (1) users’ attempting to swamp or override the therapy with larger doses; (2) substitution of one drug whose effects have been blocked with another drug whose effects have not been blocked; (3) increased incidence or prevalence of drug use because of a perception that there is less risk involved; and (4) aggressive actions of drug sellers who are losing sales to try to move into new markets. This section reviews some of the considerations associated with each of these scenarios. Users’ Trying to Swamp or Override Treatment It would be a major boon to treatment if an intervention such as immunotherapy or depot medication made a user completely uninterested in using a drug. Unfortunately, users who are offered these thera-

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions pies may still have some desire to use drugs for at least five reasons. First, as Pentel (this volume) has described, immunotherapies only partially block the transport of drug molecules into the brain. Second, effectiveness will vary over time, so that a treatment that is completely effective at one time may be ineffective at another time. Third, adherence rates for a wide range of treatment regimens have been far from perfect (not necessarily through any fault of the providers) (McLellan et al., 2000), Fourth, it is not completely clear how immunotherapies and sustained-release formulations affect drug craving (Pentel, this volume). Fifth, psychopharmacologic effects are not the sole motive for drug use (Kosten and Kranzler, this volume). It is likely that some or even many people given immunotherapies or sustained-release formulations of opioid blockers will continue to have some desire or craving to take drugs. Moreover, for some individuals, drug-taking may still have some effect on their brain (including cognition, reward pathways, and other effects). These individuals can be thought of as having received some fraction of the benefits of a 100 percent effective blocking of the drug, yet partial effects may be better than no effects at all. Individuals might continue to ingest some of the drug, but less than they otherwise would have and, hence, they and society generally would benefit. Another possibility, however, is that these individuals will try to swamp or override the partial blockade of the drug by ingesting larger doses than they would have in the absence of the immunotherapy or depot medication, resulting in greater total use than before treatment. This perverse outcome is not implausible. To caricature, if using an immunotherapy meant that twice as much of the drug had to be ingested to get the same effect, from a drug consumer’s point of view that may be equivalent to a doubling of the price of a drug. In either event (a 50 percent effective immunotherapy or a price doubling), the user would have to spend twice as much to get the “same” brain reward. The critical question is how clients in treatment who receive these medications respond to different degrees of effectiveness, individually and on average. It is quite likely that some users will periodically attempt to swamp or override the medications at any level of effectiveness. From an economic perspective, the responsiveness of consumers to price changes (or in this case, to medication effectiveness) can be summarized as the price elasticity of demand (MacCoun, this volume). In general, when prices increase (medication effectiveness increases) the amount of a commodity purchased decreases. When the price increases, the total amount spent on the commodity may decline, remain the same, or actually increase, depending on the nature and degree of change in consumption. The total amount spent on a commodity increases if the proportional

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions reduction in amount consumed is less than the proportional increase in the price. This effect is known as price elasticity: the drug is a price inelastic commodity, and the reduction in total amount spent is price elastic. (In contrast, commodities that are price elastic show proportionally equal or larger reductions in consumption as prices rise.) In the context of immunotherapies, although there is little reason to think that attempts to swamp or override treatment will lead to increases in the amount of the drug reaching the brain—since it is only the effective price of getting drugs into the brain not the actual price paid by a user to the drug seller that increases—increased spending implies increased purchasing from the seller. That is, if demand for the drug behaves as if it were inelastic in response to immunotherapy-induced increases in the effective price, there would be increased demand for drug purchases. It is not now known which drugs have elastic or inelastic demand. Originally, it was presumed that demand was probably inelastic. More recent evidence suggests that for some substances demand may be elastic, although the evidence base for this assertion is thin (see Chaloupka and Pacula, 2000, for a review). The potential problems from user’s seeking to override or swamp immunotherapies and sustained-release formulations are varied. Future studies may find it productive to differentiate among use-driven harms related to the drug’s reaching the brain (e.g., many behavioral effects) or reaching other body parts (e.g., the heart or placenta) and those associated with drug ingestion or administration itself (e.g., risks of injection). Traditional forms of treatment generally affect all three types of harms proportionally, but immunotherapies, in contrast, can be expected to influence each category to a different degree and, indeed, could reduce some while increasing others. It is not clear if these new therapies protect other body parts as well as, better than, or less well than they protect the brain. Indeed, the answer may be medication-, organ-, or drug-specific, or some combination of the three. One major concern with attempts to override the blockade effects of immunotherapy and depot medications is the risk of accidental overdose, because the level of medication effect is expected to wane over time following administration. Because there is no obvious signal to the patient that the blocking effects of an immunotherapy or depot medication have diminished after weeks or months of sustained blockade, toward the end of the effective duration of a medication dose a patient may ingest a relatively large amount of drug that had produced no overdose while the medication was more effective (more proximal to medication administration), resulting in an overdose. Some harm stems from behaviors associated with drug use itself. Those potential harms would be exacerbated if users sought to override immunotherapies’ partial blocking by taking more of the drug. Two

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions obvious examples are the spread of infectious diseases, such as the ones caused by human immunodeficiency virus (HIV) and the hepatitis C virus (HCV) through shared injection equipment and the risk of lung cancer from cigarette smoke. (The nicotine vaccine intercepts nicotine in the bloodstream, but not the tars and other carcinogens in the esophagus and lungs.) For illicit drugs, adverse consequences of swamping could extend beyond the drug user to other people. If immunotherapies reduced the amount of an illicit drug reaching users’ brains but increased demand from drug dealers, it could affect the black markets for those drugs (MacCoun and Reuter, 2001). For example, it is common to divide drug-related crime into three categories: psychopharmacological crime (that driven directly by drug intoxication or withdrawal), economic-compulsive crime (crime committed by users to get money to buy drugs), and systemic crime (conflict related to drug transactions, such as disputes among dealers over drug money). Very roughly these three components seem to account for about one-sixth, one-third, and one-half of drug-related crime, respectively (Caulkins et al., 1997). The first is driven by drug use, but the latter two categories are more directly related to drug market spending and revenues. If immunotherapies and sustained-release formulations reduced the amount of the drug reaching the brain but increased market demand, they could yield a net increase in drug-related crime and violence. The nature and magnitude of such an increase would depend on many market factors, including the elasticity of supply. Drug Substitution Immunotherapies and sustained-release medications are generally drug specific. Most are highly drug specific, while others (opioid blockers) target a class of related drugs. However, an immunotherapy that binds with cocaine, for instance, will not bind with heroin or PCP. None of these medications can bind or block alcohol. One possible behavioral response to immunotherapy or sustained-release medications for illicit drugs could be for users to substitute one (or more) substance for a blocked drug. This concern is not novel to immunotherapies, as patients in methadone maintenance programs sometimes test positive for cocaine, benzodiazepines, or other drugs and alcohol. However, it is a significant concern inasmuch as polydrug use is the norm, not the exception, among dependent substance abusers. Thus, administration of a medication specific to one drug leaves users susceptible to the use or abuse of other drugs. Still, the mere fact of drug substitution does not necessarily imply that the intervention was not helpful. For instance, the intervention might still bring benefits if the substituted drug is less dangerous than the original, but it could be counterproductive if the substituted drug is more dangerous.

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions Risk Calculations As MacCoun describes (this volume), technologies that reduce the riskiness of an activity sometimes increase the prevalence of that activity. For example, there is evidence that people in cars with seat belts and air bags drive less safely (Sagberg, Fosser, and Saetermo, 1997) and that smokers may smoke more filtered or low-tar cigarettes than regular cigarettes (Kabat, 2003). If there were such a behavioral response to immunotherapy medications it could undermine some of the hoped-for benefits. Major surveys of public attitudes (such as Monitoring the Future) carefully track the perceived danger or risk of using illicit drugs and find that, over time, increases and decreases in perception are inversely and strongly correlated with use of particular drugs (Johnson, Rosenblum, and Kleber, 2003). The question arises as to whether the availability of efficacious immunotherapies and depot medications might make the risk of addiction seem to be less dangerous and possibly invite increased use of drugs (and tobacco products). A separate mechanism that might promote initiation is the possibility that successful treatment would remove “negative role models” whose presence, and problems of dependence, serve as a caution that increases youths’ perceptions of the risks of drug use and, hence, reduces their initiation. This issue of the perception of how dangerous an addictive product appears to be is at the base of recent suits against tobacco companies related to their introduction of “light,” “mild,” and low tar and nicotine cigarettes. It is asserted by plaintiffs in these cases that their decision to smoke or continue smoking was affected by the perception that they could reduce their potential health risks by smoking these products (Kozlowski et al., 1998). Terry Pechacek, a scientist at the Centers for Disease Control and Prevention, has speculated in interviews with the news media that an effective immunotherapy for nicotine could send kids the wrong message—that as long as you don’t get addicted, it is OK to smoke. For HIV, one of the recent phenomena being studied is how the availability of increasingly effective medications affects risk-taking behavior (Blower, Schwartz, and Mills, 2003). There is a concern that HIV risk-taking behavior has increased as the perceived risk is believed to have decreased because of new medications. Thus, an unfortunate scenario might be that increases in perceived effectiveness of immunotherapies will lead to decreases in perceived risks associated with initiation and use. MacCoun (this volume) observes that there is little evidence that risk compensation completely undermines the benefits of the intervention to users. However, drug use, particularly use of illicit drugs, generates considerable negative externalities (i.e., harms to people other than the user), and the presence of such externalities increases the risk that risk compensation could turn an intervention into a net negative for society, even if it

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions continues to bring benefits for the target population in question. Specifically, illicit drug users on such a medication might buy and use more of the drug (in order to occasionally override the block), but experience fewer health consequences because of the medication. However, in order to finance the increased drug use and purchases, they may have to commit more crimes (e.g., theft, drug dealing), resulting in increased harms (externalities) to the community. Thus, to the extent that individual patients on these medications increase their total drug purchases and use in order to override the medication, there is likely to be a net negative benefit to society from that individual’s taking the medication. Sellers Illicit drug markets are not well understood, so it is difficult to predict how drug dealers would respond to demand changes induced by immunotherapies or sustained-release formulations. It is possible, however, to project some negative outcomes (see MacCoun, this volume). If the medications materially suppressed market demand, drug dealers might respond by seeking to expand into new markets or they may get more aggressive (e.g., more violent) about defending their remaining markets. Behavioral responses by sellers need not be confined to sellers of illicit drugs. Cigarette manufacturers could respond in somewhat parallel ways, for example, by increasing marketing or targeting new customer bases. At present such possibilities are highly speculative, but their possibility underscores the need for research. An entirely different set of issues is raised by the possible behavior of the sellers of the immunotherapies and sustained-release formulations and the actions they might take in order to maximize their profits. With the very conspicuous exception of nicotine, the market revenue potential for addiction treatment may be modest. The medications developed for treatment of addictions (except nicotine) have to date realized extremely limited sales, compared with medications for other disorders such as high cholesterol, diabetes, high blood pressure, and depression. Public agencies have been unwilling or unable to fund medications for drug treatment. Furthermore, many people who are dependent on illicit drugs lack health insurance or the income to pay for expensive medications. The populations that could benefit from new immunotherapies or sustained-release medications are significantly smaller than for many other health problems, and it appears that much less than a third of these populations actually get any care in a given year. On the basis of household surveys, the Substance Abuse and Mental Health Services Administration (2002) estimates that there are about 3.5 million individuals that could benefit from treatment for marijuana, and about 1 million that need

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions care for cocaine. However, when the Office of National Drug Control Policy (2001) includes the criminal justice population, they estimate that there are about 2.7 million “chronic” cocaine abusers. Studies estimate that there are somewhat fewer than 1 million heroin- or opioid-dependent individuals (Office of National Drug Control Policy, 2001). There appear to be no rigorous published estimates of the size of the population in need of treatment due to methamphetamines, although in arrestee and treatment populations they are less than one third the size of the heroin population (thus, fewer than 300,000). The PCP user population is a small fraction of the methamphetamine user population. The potential market for use of immunotherapies to treat overdoses can be crudely gauged from data on emergency room visits involving various illicit drugs (Substance Abuse and Mental Health Services Administration, 2003). In 2001 there were 638,000 emergency room episodes involving illicit drugs, of which 193,000 involved cocaine (any form), 15,000 involved methamphetamines, and 6,000 involved PCP. Unfortunately it is difficult to estimate demand for a medication from this data because not every visit that involves a particular drug type may require treatment for overdose. However, some patients with potential symptoms of overdose may be given an immunotherapy as a precaution before it is ascertained that they actually ingested any, or a particular, drug. As discussed in other sections of this report, there is concern that there may be interest in off-label use of these medications for “protective” purposes with certain vulnerable populations. For illicit drugs, the potential market in drug use prevention or “protection” is numerically far larger than the potential market for addiction or overdose treatment, even if one considers only juveniles: there are about 4 million youth per birth cohort, or about 16 million youths between the ages of 14 and 17, inclusive. Consequently, companies that develop these medications may want to see them used for protection. FDA regulations restrict marketing of pharmaceutical products for indications or uses that have not been researched and approved. However, this regulation provides little assurance that the companies will either perform the necessary and costly research and go through the approval process for protective use in vulnerable populations or actively educate physicians about the lack or research for and potential risks with such use. If these medications are approved for treatment or for overdose, it would be important to track the behavior of pharmaceutical firms with respect to their off-label “protective” use. We believe that it is worth repeating that this committee strongly recommends that NIDA support appropriate research at an early date on vulnerable populations, particularly because of the strong and well-intentioned motives there may be to administer immunotherapy medica-

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions tions for protective purposes, and the unfortunately negligible—or even financially perverse—incentives for pharmaceutical companies to do the needed research and educate physicians. This quick summary of some of the possible unintended behavioral consequences of developing immunotherapies shows that many of them lie entirely outside the usual FDA review process. That is, even if a therapy were correctly judged to be safe and efficacious, many if not most of these potential adverse scenarios would remain concerns. This, again, strongly suggests that the research agenda associated with immunotherapies ought to extend well beyond those that are customarily considered in pharmacotherapy development. Recommendation 6 The National Institute on Drug Abuse should support studies of behavioral consequences, such as the increased potential for accidental overdose and changes in drug use patterns which may include switching drugs, increasing drug dosage or overall consumption, changing the route of administration (e.g. nasal to intravenous for greater bioavailability) or, conversely, avoiding use of other addictive substances. Recommendation 7 The National Institute on Drug Abuse should support studies that examine the extent to which the availability of immunotherapy medications might reduce the perceived risk of drug use and the effects of such perceptions on drug use behavior in various populations. Recommendation 8 The National Institute on Drug Abuse should support studies of the potential effect of immunotherapy medications on illicit drug markets and market-related behaviors. CONSENT AND VULNERABLE POPULATIONS As noted early in this report, the committee has particular concerns around behavioral, ethical, legal and social issues for vulnerable populations. Such populations include adolescents, pregnant women, and those involved with the criminal justice and child welfare systems. These populations are vulnerable in several different respects. First, such populations are often excluded from clinical trials of new medications; thus, less is known about the safety and efficacy of new treatments with them. Second, the range and degree of behavioral responses to immunotherapies and sustained-release medications for adolescents and pregnant women and their fetuses may be different from those of adult males and nonpregnant females, who are likely to be the participants in initial clinical trials. Finally, people in these populations may be susceptible to being coerced to accept therapies that they would reject if free to make their own decisions.

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions The committee fully expects that in the vast majority of cases, immunotherapies and sustained-release medications will be used appropriately with such vulnerable individuals: individuals will be given the opportunity to voluntarily consent to this treatment modality after being informed of the risks and benefits of the treatment and informed of other treatment options. However, even infrequent, well-intentioned misuses and abuses of these therapies with vulnerable individuals might receive significant public attention and might have an adverse effect on the acceptance and use of these potentially important advances in treatment for addictions. Therefore, the committee recommends (above) early, preclinical research on the use of these therapies in vulnerable populations, the outcome of which may be useful for determining whether and when clinical trials involving these groups should be undertaken. The challenge in prescribing these medications for vulnerable populations is inextricably linked with individuals’ rights to consent to or refuse medical care, after receiving complete information. While medical consent is a nearly unqualified principle in the U.S. health system, adherence to this principle may be compromised in the zeal to address tobacco and drug addiction among individuals whose drug dependence places them in coercive settings. Adherence to informed consent may consequently require constant monitoring. This section reviews three issues related to providing immunotherapies and sustained-release formulations to these vulnerable populations: standards related to an individual’s right to determine care; providing these medications to minors; and providing these medications to adults who are mandated or coerced to receive them. The Individual Right to Determine Care Legal Considerations Competent adults have the right to make their own decisions about whether to accept or reject medical treatment, including life-sustaining treatment, free from interference by anyone, including the state (Ridgely, Iguchi, and Chiesa, this volume). This right is based on the constitutional rights to liberty and privacy grounded in the Fifth and Fourteenth Amendments and the common law right of bodily integrity and self-determination. The right to make medical decisions is maintained through the doctrine of informed consent, which prohibits a physician from performing any medical procedure without first explaining all relevant information and obtaining the individual’s knowing and voluntary agreement (see Kaimowitz v. Department of Mental Health for the State of Michigan, 1973).

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions Individuals who are not deemed competent to provide consent as a result of age, mental condition, or mental capacity grant consent to medical care through a guardian. Even individuals who have been institutionalized because of a mental illness are presumed competent to make their own medical decisions, unless they are adjudicated incompetent (under standards established by state statutes). The voluntary nature of consent is not necessarily suspect if rendered in a coercive setting (e.g., prison) or under coercive circumstances (e.g., facing the prospect of civil commitment). To the extent that a state-based coercive setting exists, the provision of procedural due process protections (e.g., advice of counsel or independent review by a judge or administrative hearing officer) and other protections (e.g., nonexperimental treatment and “good faith” dealing) have been found to adequately protect the voluntariness of the coercive decision-making process (Rogers v. Commissioner of the Department of Mental Health, 1983). Studies with psychiatric populations also demonstrate that courts are more likely to view “coercive” acts and processes of the state as legitimate if moral norms of fairness, good faith dealing, respect, and consideration of patient views are provided (Appelbaum and Grisso, 1995). In the drug treatment context, drug-dependent individuals who might benefit from immunotherapies or sustained-release formulations (approved by the FDA for treatment purposes) have the right to be informed of the risks and benefits associated with the treatment and to provide or withhold their consent for its use. The fact that an individual’s decision-making ability may be affected by the use of a psychoactive substance (either temporarily or for an indefinite time) does not affect his or her right to consent, unless an independent determination of incompetence has been made. The voluntariness of the consent must be evaluated in the particular context in which it is rendered and the establishment of due process protections tailored to the particular context. An institutional review process to assure good faith dealing and full disclosure of medical information would likely satisfy existing legal standards. These protections would also be fundamental to decision making in a situation in which the long-term health effects of the therapy are not known and the potential for identification of a drug use history—and therefore the potential for discrimination—exists. Ethical Considerations In addition to legal considerations, there are ethical issues that affect the right of individuals to determine the kind of care they receive. Three core ethical principles in medical treatment and research are respect, beneficence, and justice (Dresser, 1996; Sieber, 1994). These principles

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions were outlined in the “Belmont Report” (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978), which governs the conduct of research on human subjects. These principles also have implications for the consent process and offering treatments to patients. Respect, as enunciated in the Belmont principles, requires that researchers and clinicians view patients and study subjects as autonomous agents who are able to make decisions about what they will and will not do, as long as those decisions and resulting actions do not cause harm to others. Respect also means that patients who are not capable of exercising autonomy are protected from actions that would be harmful to them. For patients who are not able to exercise autonomy or who have a diminished capacity to make these decisions, a balancing act is required that considers the potential risks and benefits of the proposed action or treatment. Beneficence is also defined in terms of two general rules. Beneficence requires that clinicians not take actions that may potentially harm their patients. It also requires that any potential benefits be maximized, while any prospective harm is minimized. The benefits can be for the patient or for the larger society. The principle of justice focuses on the recipients of benefits and the burdens of medical procedures. Justice, in this context, focuses on fairness in the distribution of the benefits or the unjust application of the burdens. The National Advisory Council on Alcohol Abuse and Alcoholism (1988) and the National Advisory Council on Drug Abuse (NACDA) (1997) have applied these principles to working with individuals who have substance use disorders. The NACDA guidelines, for example, suggest that individuals be given the opportunity to choose what does and does not happen to them and also speaks to the importance of providing protections for persons with diminished autonomy or capacity. Beneficence requires that researchers not only seek to minimize any potential harms, but also work to maximize the potential benefits to the individual and to society. Justice requires a fair and equal distribution of benefits and burdens of research involving human subjects. In terms of consent issues, the NACDA guidelines require that researchers: assure that an informed consent process is in place that gives individuals all the information needed to make decisions; give adequate consideration to the mental and physical condition of participants to ensure that they fully understand the “context of consent;” conduct an independent evaluation if there is a question about a person’s ability to comprehend the consent process; and update the informed consent process when new data about safety and efficacy are available. Even with this guidance, some people have questioned the capacity of individuals with substance use disorder diagnoses to consent to par-

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions ticipation in research or to clinical care (McCrady and Bux, 1999). These questions have focused on whether a person can understand the procedures (DeRenzo, 1994), whether the person’s decision-making capacity is impaired because of substance use (Dresser, 1996; Cohen, 2002), and the nature of the informed consent process itself (Shimm and Speece, 1992). Despite these concerns, however, the literature that examines these issues is limited (McCrady and Bux, 1999). The NACDA guidelines were developed with an awareness of these issues. Adherence to the ethical principles discussed above and use of guidelines has served to help researchers and clinicians appropriately include individuals with substance use diagnoses in their research, woth their giving consent to treatment, barring any indication of diminished autonomy or capacity. The Belmont principles and NACDA guidelines support the considerations noted above, in terms of the ability of drug-dependent individuals to make their own decisions about receiving immunotherapies or depot medications, with the full knowledge of the expected risks and benefits of treatment, as well as an understanding of alternative treatments that may be available. However, in terms of the vulnerable populations that we refer to throughout this report, these ethical principles require that basic knowledge be available to help inform those decisions. For instance, it is necessary to have information about the likely short-term and long-term effects on pregnant women and their fetuses and how immunotherapies and depot medications might affect the behavioral and physiological development of children and adolescents. Absent any data that might answer these questions for these populations, the committee recommends preclinical studies to elucidate these issues prior to clinical studies with these populations. Minors If and when immunotherapies for tobacco or illicit drugs receive FDA approval, some parents may seek to have their children immunized to attempt to “protect” them against addiction. There are a number of issues that should be examined in anticipation of this use, some of which have been described above. Certainly, the primary consideration concerns the safety and efficacy of the therapies in adolescents, which may be somewhat different from the safety and efficacy for adults because of developmental and behavioral differences. A second key consideration involves who makes the decision about treatment and whose decision prevails if an adolescent is unwilling to undergo treatment. Moreover, if parents or guardians overrule an unwilling adolescent, there may be effects on the parent-child relationship, which should be examined. In most cases, the law recognizes the rights of parents or guardians to

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions make medical decisions for their children, absent other state standards. This recognition is captured by a statement made by the U.S. Supreme Court in the case of Prince v. Massachusetts (321 U.S. 158, 1944), “It is cardinal with us that the custody, care and nurture of the child reside first in the parents, whose primary function and freedom include preparations for obligations the state can neither supply nor hinder.” The law recognizes, however, that there are situations in which legal intervention may take place to overturn parental decisions; “… if it appears that parental decisions will jeopardize the health and safety of the child” (see Wisconsin v. Yoder, 1971). Under these situations, the state may step in to seek permission from the judicial system to assume guardianship status for a specific life-threatening or life-altering medical situation (e.g., when a child requires blood transfusions or chemotherapy or for a child with massive facial disfiguration). These legal parameters suggest that for minors, parents and, in well-defined circumstances, the state (often through the courts), have a major say in medical decision making. The law presumes that children under the age of 14 lack the capacity to give meaningful consent to their own medical treatment because they lack the maturity and the ability to judge both short- and long-term implications of illness and treatment. For adolescents between the ages of 14 and 18, although constraints remain, the law supports the need for their assent to treatment as their cooperation for treatment is well recognized. In addition, statutes in some states permit adolescents to make particular medical decisions without parental review. Indeed, the laws in many states already give adolescents the right of consent to alcohol and drug treatment. Thus, medical decision making for children and adolescents is affected by the minor’s age and the particular type of medical care at issue. In general, parents (or guardians) make three kinds of medical decisions for their children: (1) routine preventive or protective measures, such as standard childhood immunizations; (2) therapies for previously diagnosed medical problems, such as ongoing urinary tract infections or broken limbs; and (3) improvement of physical, intellectual or emotional well-being such as use of growth hormones where no diagnosed medical condition exists (Miller and Klanica, this volume). This third category of medical decisions is the most controversial and would presumably apply if parents wanted to use immunotherapy to protect an adolescent against the potential use of tobacco or drugs. Under what circumstances are parents permitted to make medical decisions that fall in the third category, in which there is no medical necessity for the therapy? How would a court resolve a dispute between a parent and an unwilling adolescent? Guidance from the legal system is extremely limited (Miller and Klanica, this volume). Probably the most

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions extreme situation is whether the therapy administered to a minor has long-term implications for the child when she or he reaches maturity. The potential long-term effect of immunotherapies and sustained-release formulations highlights the need for data to address this concern and underlies the earlier recommendation that preclinical studies with minors be conducted before clinical trials are undertaken. Coerced Treatment for Adults The human and societal costs of drug dependence have compelled virtually all sectors—medical, criminal justice, education, child welfare, social services, and religious—to search for effective solutions to prevent and treat drug dependence. If, and when, the safety and efficacy of immunotherapies or sustained-release formulations is demonstrated, the severity of the drug problem together with the promise of these therapies may result in a push in some state agencies to mandate the use of these therapies for drug-dependent individuals in the civil or criminal systems. Individuals with drug problems can already be required to undergo treatment as a condition of their criminal justice status (whether incarcerated, on probation or parole, or through diversion program), or to participate in the child welfare system, by virtue of their inability to care for themselves or reliance on public benefits (cash assistance, public housing or other disability benefits) (Ridgely, Iguchi, and Chiesa, this volume). In such cases, treatment is deemed to be mandated or coerced since the failure to participate in or comply with the proscribed treatment can result in the loss of freedom (incarceration or civil commitment), parental rights, or receipt of basic means for sustenance and health care. The potential use of immunotherapies for overdose treatment, relapse prevention, or primary prevention adds a new wrinkle to mandated treatment. The key question here is whether individuals may be required to receive a specific type of pharmacotherapy, rather than some kind of treatment—behavioral, medication based, or some combination of the two. The statute and case law are not settled around this issue. Unquestionably, mandated treatment for drug dependence is lawful in some circumstances. There is no clear answer, however, in the drug treatment setting, on whether the state could, acting under either its police power or parens patriae authority, require an adult who does not consent to treatment with immunotherapies or sustained-release formulations to participate in such treatment. Most of the legal standards that address the mandatory use of particular medications have been based on persons with mental illness who pose a danger to themselves or to other people and who refuse to take medications (Ridgely, Iguchi, and Chiesa, this volume). It will be necessary to extrapolate from these and other legal principles

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions and precedents when evaluating the legality of the potential mandatory use of the new therapies. Some states have exercised their police and parens patriae powers to enact and (much less frequently) enforce civil commitment statutes (Ridgely, Iguchi, and Chiesa, this volume). These statutes permit the involuntary detention of individuals with alcohol and drug dependence who have been determined through some adjudicative process to be dangerous to themselves or others or, depending on the particular statute, to be incapacitated or unable to care for themselves. However, there are few legal standards that apply with immunotherapies and sustained-release formulations. States rarely use their civil commitment authority to deal with drug-dependent individuals who may require treatment. Moreover, only a small number of state statutes actually require the availability of treatment as a precondition for commitment. To apply the forced medication standards that have evolved for mental illness in the context of civil commitment to these new therapies, a state would be required to obtain a separate finding of incompetence to medicate an individual against his or her will. Moreover, courts have required an examination of the medical appropriateness of the medication, the potential adverse side effects and the availability of less intrusive measures when determining whether to override the liberty and privacy interests of the individual who objects to forced medication (Sell v. United States, 2003). States have used their police powers much more often to mandate treatment as a condition of an individual’s criminal justice status, either in a correctional facility, for those seeking probation or parole, and for those who participate in diversion programs. Mandatory prison-based treatment requirements, which are established through either state statute or administrative practices, vary widely, and most efforts do not proscribe the type of treatment that must be provided. (The availability of any treatment is often the most significant problem). Looking again to the mental illness context for guidance on whether an incarcerated individual can refuse to undergo a particular type of treatment, the Supreme Court has enunciated a qualified right of mentally ill individuals to refuse psychotropic medication. The government’s interest to compel treatment has been held to outweigh an inmate’s right to refuse psychotropic medication in one case when the inmate was found to be dangerous and treatment was deemed by professionals to be in his best interest. In a second case, the Supreme Court upheld a medication requirement when treatment was necessary to restore the individual to competency to stand trial for a serious crime, there was evidence that the medication was justified by safety considerations, and no less intrusive means existed to accomplish the same result. The Supreme Court clarified the

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions standard for permitting forced medication just recently in Sell v. United States (2003). The Court said that the government interest at stake must be important, forced medication must significantly further those state interests, there must be no less intrusive treatments likely to achieve substantially the same result, and the treatment must be medically appropriate. These same standards should guide an evaluation of whether a state could impose treatment with immunotherapies or sustained-release formulations in a prison context. State and federal authorities also have wide latitude to impose treatment requirements as a condition of probation or parole, and courts have enforced those conditions. Individuals who accept but then violate those conditions, including the refusal to comply with treatment, may be punished through revocation of probation or parole and face renewed incarceration. Again, the imposition of a particular type of treatment on parolees or probationers appears to be less of an issue than the dearth of treatment for most of those who need it. Yet to the extent that community-based services are offered and rejected by an individual, he or she would be subject to revocation of probation or parole. The same standards would likely apply in drug court or diversion programs: refusal to comply with the treatment requirements could be the basis for a finding of noncompliance that triggers consequences in the criminal justice system. Perhaps the most controversial area of coerced treatment relates to prenatal use of drugs. Some states have adopted public health as well as punitive policies to address maternal drug use, including the identification and referral to treatment of women who use drugs prenatally; monitoring and enforcement of civil child abuse and neglect statutes following the birth; and prosecution under existing state criminal laws for neglect or other drug delivery crimes during pregnancy and after birth. With the exception of South Carolina, no state has adopted the position that a fetus is a “person” for purposes of prosecuting civil and criminal abuse and neglect laws against a woman who use drugs during pregnancy. Importantly, the Supreme Court has held that pregnant women do not lose their constitutional right to be free from warrantless searches and seizures even if the state’s goal is to detect drug use during pregnancy. The imposition of a particular type of treatment on pregnant women has been less of an issue than the therapeutic value, need, and clinical capacity to impose any type of treatment given the severe shortage of services that are appropriate for and available to pregnant and parenting women. The mandatory use of immunotherapies for pregnant women who do not voluntarily consent raises the particular issue of whether safety data will be available to make the necessary determination of safety and efficacy of these therapies for pregnant women and fetuses, which would be required before being imposed.

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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions There is little question that child protective services can mandate persons who have custody over children to seek evaluation and treatment for drug dependence and successfully complete treatment as a condition of retaining custody of children. Those who fail to comply with treatment requirements and who are found, after due process, to be negligent or abusive may have parental rights terminated. Nothing in the case law sets limits on the specific treatment modality that can be mandated, although basic fairness would require that an immunotherapy or sustained-release formulation be deemed safe and effective before being imposed. Decisions about the coerced use of immunotherapies must also take into consideration the potential stigmatization of both the individuals who are required to participate in the treatment and the treatment itself. There is a risk that an individual who has been actively immunized can be identified through the use of a blood test for a long time. That information might then be used to adversely affect employment, insurance, and other necessities of life. While discrimination on the basis of a past drug history is currently prohibited under the Americans with Disabilities Act and some state disability discrimination statutes, the scope of those protections for persons with disabilities has been limited by the courts. Care must be taken in imposing a treatment that could result in potential negative consequences long after an individual has stopped drug use. It is also important to ask whether the coerced use of immunotherapies could cast a shadow on this new therapy that, if found to be effective and safe, might significantly change the face of drug treatment. Such a stigma might deter individuals from accessing a potentially useful treatment and further inhibit the mainstreaming of drug dependence treatment into general medical practice. Recommendation 9 The National Institute on Drug Abuse should support studies to determine the standards to be applied when immunotherapy medications are considered for use in the criminal justice and child welfare systems, including due process protections when there is a government-imposed treatment requirement. Recommendation 10 The National Institute on Drug Abuse should support studies to carefully articulate the behavioral, ethical, and social risks associated with treatment of pregnant women and their fetuses and protective therapy in minors and to develop clinical practice guidelines for such use or discouragement of such use.