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Immunization for prevention and treatment of cocaine abuse: legal and ethical implications1
Drug and Alcohol Dependence 48 (1997) 167 – 174
Immunization for prevention and treatment of cocaine abuse: legal and ethical implications1 Peter J. Cohen Medications De6elopment Di6ision, National Institute on Drug Abuse, National Institutes of Health, Rock6ille, MD, USA Received 14 October 1996; accepted 21 May 1997
Abstract A cocaine vaccine, currently under investigation by several laboratories, would be an innovative and exciting means of treating and preventing cocaine addiction. However, an approved vaccine will raise at least two major areas of concern. (1) Loss of privacy: cocaine antibodies might be used as a marker to identify, penalize, and stigmatize vaccinated individuals. (2) Selection for vaccination: should immunization be voluntary or compelled; should immunization be restricted to addicts, to those at risk of addiction, or should it be universal; should immunization be used in children? I propose to analogize cocaine addiction to an infectious disease which poses a major public health problem. This approach can provide an ethical and legal foundation on which we may begin to formulate a societal approach to the use of the cocaine vaccine. © 1997 Elsevier Science Ireland Ltd. Keywords: Cocaine vaccine; Addiction therapy; Stigmatization and discrimination; Privacy and confidentiality; Law and ethics
1. Introduction Behind every silver lining is a cloud (Anon) Drug addiction remains a major public health problem (Fulco et al., 1995) in spite of extensive efforts devoted to its eradication. The identification of opioid receptors and elucidation of their pharmacology (Nutt, 1996) explains the success of intervention either by agonist (Weinstein et al., 1993) or antagonist (Kleber, 1985) administration. The molecular mechanisms of cocaine addiction, in contrast, are less clear (Mendelson and Mello, 1996), and pharmacological attempts to ameliorate addiction-associated craving and relapse have been far less successful. Currently ‘‘there are no 1 This manuscript is an expanded version of a presentation at the NIDA Symposium held during the 27th Annual Medical-Scientific Conference of the American Society of Addiction Medicine, April, 1996. The views and opinions expressed herein are those of the author and do not necessarily reflect those of the National Institute on Drug Abuse.
pharmacologic treatments for any aspect of cocaine addiction’’ (Leshner, 1996). In view of our incomplete knowledge of the specific site or sites involved in the production and maintenance of cocaine addiction, it would be useful to develop a means of inactivating the drug before it can gain access to the central nervous system. Immunology offers an exciting and innovative approach to such therapy. The use of immunology-based pharmacology in treating addiction would not be unique; for example, severe digitalis intoxication is amenable to therapy using specific antibodies (Smith et al., 1976, 1982). Immunopharmacology may have a significant role in treating and preventing cocaine addiction. It has recently been shown that rats may be actively immunized against cocaine (Carrera et al., 1995). Following immunization, the animals manifested an altered behavioral response to parenteral cocaine, thereby demonstrating an effective titer of cocaine antibodies which could bind to cocaine prior to its entrance into the central nervous system. This phenomenon set the stage for both treating and preventing cocaine addiction.
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There may be significant advantages to instituting therapy which acts on the addictive drug directly rather than attempting to change the nature of the receptor(s), since these receptors are likely to have numerous other important functions. Hopefully, immunological therapy would not produce undesirable psychological or neurological side effects. Finally, it might involve only a few initial injections followed by periodic ‘booster’ injections (Self, 1995). Many studies will be required to prove the safety and efficacy of this approach. Among the questions to be answered are whether antibody levels will remain sufficiently high to block the action of all practicable doses of cocaine, and whether hypersensitivity reactions to cocaine will develop (Self, 1995). Furthermore, while antibody specificity is essential if cross-reactivity with local anesthetics is to be avoided, this attribute will also limit the utility of the vaccine since the actions of other stimulants (e.g., amphetamines) will remain unaffected. Finally, immunotherapy does not deal with any underlying behavioral pathology that may contribute to and potentiate the addiction. These are significant scientific questions which must be answered before there is any possibility of the cocaine vaccine’s acceptance into the armamentarium of addiction medicine. Nonetheless, if development were successful, such therapy would be a boon to society. However, science does not exist in a vacuum: scientific discoveries perturb society. As an example, the Human Genome Project will provide vast new knowledge with the potential for helping society; it also may lay the foundation for significant abuse such as discrimination and stigmatization. The silicon chip led to the computer, but also opened the door to a significant diminution of individual privacy. A similar dichotomy between benefits and burdens may be exhibited by the cocaine vaccine. Although its efficacy is yet to be demonstrated in human addicts, initial clinical studies are scheduled to begin by the end of this year. Thus, while approval by the Food and Drug Administration (FDA) is undoubtedly years in the future, it would be wise to address potential ethical and legal questions now. Postponement will only result in emotional debates after the vaccine has been accepted as part of medical practice. Representative of the need for advance planning are today’s technologies of assisted reproduction which arose without regulation or significant ethical analysis. A perfected vaccine could be used both to prevent and treat cocaine addiction. The vaccine will have no effects on the immunized individual except in the context of cocaine use. After ingesting cocaine, the immunized person will not experience a ‘high’, thus diminishing the likelihood of repeating the drug use. Relapse in the detoxified addict will not be associated with euphoria; without such re-enforcement, the behavior is unlikely to continue. What possible ethical or
legal problems could result from such an apparently beneficial methodology? The aim of this communication is to outline some of the inevitable ethical questions that will arise from the immunological approach to cocaine addiction. These questions will be posed and methods proposed for their analysis, but definitive answers will not be provided at this point. While it might be more satisfying to the reader were I to provide firm ‘truths’, such an absolutist approach would be inappropriate. For as society seeks to develop a consensus that will enable formulation of a policy, scientists, attorneys, bioethicists, specialists in addiction medicine and others will provide their expertise. Eventually, however, the final decision must be taken only after considered thought and debate by an informed public. This discussion will assume that the FDA might at some point approve a vaccine capable of predictably stimulating formation of cocaine-binding antibodies with a minimum of side effects. However, the legal and ethical analysis would require modification if significant adverse responses were observed. Peripheral issues such as lack of industrial interest because of perceived problems with litigation and lack of governmental indemnification for adverse effects will not be addressed. Finally, while this mode of therapy may engender certain unique problems (e.g., potentially intrusive attempts to detect antibodies not directed at an infectious agent) other ethical challenges do not present de novo (e.g., issues of coercion and confidentiality). In view of the major public health hazards of cocaine addiction, the fact that not all problems raised by this therapy are novel ought not preclude a comprehensive discussion of all aspects of this mode of therapy.
2. Potential for stigmatization The concept of privacy is prized in American society, although it is not specifically mentioned in the Constitution. Privacy implies that every person, by virtue of being a person, has the right to inviolate space within which he or she has ‘‘the right to be let alone—the most comprehensive of rights and the right most valued by civilized men’’ (Olmsted, 1928). This right makes axiomatic the requirement that information dealing with an individual’s health is not to be shared by health care professionals with others without informed and competent consent. However, neither our law nor social ethos considers the right to confidentiality to be absolute. An important judicial decision (Tarasoff, 1976) held that threats to other individuals must be balanced against claims of patient confidentiality. Should a patient reveal to a psychotherapist that he or she intends to inflict serious harm on another, the therapist must
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give warning. The California Supreme Court held that the therapist: incurs an obligation to use reasonable care to protect the intended victim against such danger. The discharge of this duty may require the therapist to…warn the intended victim or others likely to apprise the victim of the danger, to notify the police, or to take whatever other steps are reasonably necessary under the circumstances. The Tarasoff court extended its decision to infectious diseases: a doctor is liable to persons infected by his patient if he [sic] negligently fails to diagnose a contagious disease, or, having diagnosed the illness, fails to warn members of the patient’s family. Furthermore, numerous statutes require that certain communicable diseases be reported to appropriate public health authorities. As with communicable diseases, a cocaine vaccine will also raise questions of individual privacy. Unlike some (but not all) communicable diseases, the balancing between individual privacy and public welfare will have the added factor of the stigma ascribed to drug addiction by a sizable portion of society. The cocaine-binding antibody will be responsible for the beneficial effects of immunization. However, the presence of this antibody will also create a major ethical problem related to privacy, since it will be possible to detect it in the blood of immunized persons. Information concerning an immunized individual’s positive cocaine-antibody status (analogous to HIV-positivity) will be difficult to keep hidden, as it will appear in their medical records. This may lead to stigmatization and discrimination, for it will suggest that vaccinated individuals are cocaine addicts, or at least are ‘susceptible’ to addiction. Society will have to deal with legal and ethical considerations regarding privacy and prejudice in a vulnerable population, a situation similar to that which now accompanies disclosure of HIV-positivity. Parenthetically, this same issue would become relevant to the AIDS community if an HIV vaccine were perfected. The problems of confidentiality, however, are not unique to a cocaine vaccine. Methadone and disulfiram (Antabuse™) can be measured in blood and, if detected, can also subject individuals to discrimination. Furthermore, this ethical difficulty is not confined to the arena of addiction: medical records in general, once considered inviolate in terms of privacy, are subject to widespread dissemination. While the motive for such abrogation of confidentiality may represent the darker side of humanity (curiosity, greed, revenge, intrusion of
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an unauthorized attorney), modern medical practice frequently mandates that such data be made available to numerous health care professionals (Alpert, 1993) as well as insurance under/writers, managed care companies and state databases. Gostin (1995a) has forcefully addressed the tension between privacy and availability of medical information in modern medicine. If society wishes the benefits of comprehensive, accurate and portable medical records, and those of a cocaine vaccine, it must institute legal and behavioral changes that will preserve privacy and confidentiality. The law, both legislative and judicial, is one means by which ethical and moral imperatives may be translated into action making it possible for them to become a force to change society (Alpert, 1993; Gostin, 1995a). Federal statute provides that the ethical mandate of confidentiality be enforced for records of addicted patients—42 U.S.C. § 290ee-3 states: Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any drug abuse prevention function conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall [except within the Armed Forces or Veterans Administration, or when exempted by State laws dealing with child abuse or neglect] be confidential and be disclosed only for the purposes and under the circumstances expressly authorized [e.g., with consent, in a medical emergency, under court order]. While the law may be used to transform morals or ethics into action, it is equally true that law without ethics will be to no avail. An individual who has been deprived of privacy may certainly litigate on the basis of a confidentiality statute. However, litigation is long, costly and emotionally draining. A meaningful answer requires that our ethos undergo a change such that individual privacy becomes a prime value to every member of society.
3. Potential for coercion Once the safety and efficacy of the cocaine vaccine have been demonstrated, society will confront the inevitable question: who will be vaccinated? The answers comprise a continuum of possibilities ranging from voluntary vaccination of competent adults to universal and mandatory immunization.
3.1. Consenting adults and children Since this discussion assumes the vaccine to be both safe and effective, there should be few problems with its
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administration to competent consenting adults. The immunization of children brings us to a more controversial area. There is a consensus that parents have a major responsibility for the welfare of their children. Does this include the right to have their children immunized if they believe this treatment to be in these children’s best interests? Is a minor child’s age to be considered in requiring ‘assent’ in addition to parental consent? Kun (1996) provides an affirmative response; she has proposed that statutes giving ‘‘minors a substantial, although not exclusive, role in medical decisions would recognize that certain minors have the requisite decision-making capacity to play a role in their health care choices’’.
3.2. Con6icted criminals Further along the continuum we enter the criminal justice system and the conditions for probation and parole for those convicted of a crime. Courts may sentence convicted felons to probation; 18 U.S.C. § 3563(b)(10) allows the court to require that a defendant receiving probation: undergo available medical, psychiatric, or psychological treatment, including treatment for drug or alcohol dependency, as specified by the court, and remain in a specified institution if required for that purpose. Supervised release (parole), governed by 18 U.S.C. § 3583(d)(3), allows requirements ‘‘consistent with…any condition set forth as a discretionary condition of probation in §3563(b)…(10).’’ Thus, courts currently may offer alternatives (both behavioral and pharmacological) to incarceration, and may impose conditions for parole: these include community service, attendance at meetings of Alcoholics Anonymous, participation in methadone programs, and/or residence within a therapeutic community. Physicians and attorneys who have become addicted to opioids may be mandated to use naltrexone in order to maintain their licensure. Do the above considerations suggest that our courts should include cocaine immunization as a condition for probation among their judicial options? While the answer might appear obvious at first glance, the issue is complicated by the question of whether treatment with the cocaine vaccine would constitute cruel and unusual punishment forbidden by the Constitution’s Eighth Amendment. Even if it were not deemed ‘punishment’ (since one could argue that it is an alternati6e to punitive incarceration), there is still a significant element of coercion. Furthermore, there are limits to the conditions that are acceptable for probation or parole. For example, castration of sex offenders (the efficacy of which is controversial) is impermissible even if under-
taken on a ‘voluntary’ basis. Many courts have struck down statutes imposing castration as part of a prison sentence or as a condition of probation/parole, holding that the procedure violates the Eighth Amendment and fails to give due process (Ghent, 1995). As early as 1914 (Davis, 1914), a federal court declared of castration: The physical suffering may not be so great, but that is not the only test of cruel punishment; the humiliation, the degradation, the mental suffering are always present and known by all the public, and will follow [the defendant] wheresoever he may go. This belongs to the Dark Ages. Recent legislation in California mandating ‘chemical’ castration (by means of weekly injections of DepoProvera™) for ‘‘child molesters and other violent sexual predators’’ (Stern, 1996) will undoubtedly force our courts to address this issue again. In any case, one can argue that, unlike castration, the vaccine will have proven safety and efficacy, may have a finite duration of action and need not be accompanied by ‘humiliation and degradation’. Less extreme, but also a controversial pharmacological intervention, is the offer of disulfiram to defendants convicted of drunken driving as an alternative to jail. This practice has been criticized (Marco and Marco, 1980) largely on the basis of unquantified risks of disulfiram, many of which were related to ingestion of alcohol. Furthermore, the analysis should have balanced the risks of disulfiram with its benefits, i.e. lessening the significant direct harm of chronic abuse of alcohol as well as the likelihood of death of the alcoholic and innocent members of society should the impaired driving be continued. Informed and thoughtful bioethicists may differ in their response to judicial imposition of a cocaine vaccine in criminal cases. How the legal process answers the question of whether vaccination should be allowed, and, if so under what circumstances, will undoubtedly require considerable litigation, with the ultimate decision likely being rendered by the Supreme Court. If judicial discretion is extended to the cocaine vaccine, should use of this tool be restricted to those convicted of specific drug-related offenses? Or, since drug addiction is ‘endemic’ in those convicted of a wide variety of crimes (Drug Use Forecasting, 1994), should the vaccine be available for courts to use with all convicted persons?
3.3. Addicts who ha6e not committed a crime How may we use the cocaine vaccine when confronted with addicts who have not been involved in any criminal activity? While criminal law may permit immunization under specific circumstances, it cannot justify
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administration of the vaccine to those who have committed no criminal acts. Ci6il law is another matter: although the ‘status’ of addiction may not be made a crime (Robinson, 1962), the disease of addiction is often associated with behavior which poses a serious threat both to the individual and society. Reacting to the possibility of future harm, the Robinson court also held: In the interest of the general health or welfare of its inhabitants, a State might establish a program of compulsory treatment for those addicted to narcotics. Such a program of treatment might require periods of involuntary confinement. And penal sanctions might be imposed for failure to comply with established compulsory treatment procedures. Civil commitment has been used as a means of instituting compulsory treatment of drug addicts for over a quarter of a century (Leukefeld and Tims, 1990). The Federal Narcotic Addict Rehabilitation Act of 1966 (Public Law 89-793; 18 U.S.C. §§ 4251 – 4255) authorizes compulsory civil commitment and treatment, as do California and New York statutes. Federal and state civil commitment programs were in full operation from 1965 to 1975 at which time they were replaced by programs of community drug treatment (Leukefeld and Tims, 1990). Would not the use of a cocaine vaccine be far less coercive?
3.4. Non-addicted population Should the vaccine be used in the absence of addiction or criminal conviction, but when an individual (or population) is deemed to be ‘susceptible’ to addiction? Mandatory vaccination of ‘targeted’ populations outside the criminal justice system is fraught with potential for prejudice, discrimination and unfairness. As a result, this approach would face severe Constitutional challenge. Paradoxically, these problems would be obviated if society adopted the obvious and inevitable policy of mandatory universal vaccination. This will be examined in more depth in the next section which will also propose an analytic methodology. Suffice it to say at this point that universal immunization would also eliminate the problem of stigmatization: if everyone were antibody-positive, that status would no longer result in discrimination or prejudice against any one person!
4. The continuum of possibilities: a proposed analytic method The potential for stigmatization, discrimination, loss of privacy and coercion presents significant problems
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that society will confront once the vaccine becomes available. Before we can attempt to arrive at an ethical and legal consensus, we must agree on an analytic framework. Addiction is ‘‘a chronic medical disorder…in a category with other conditions that show a similar confluence of genetic, biological, behavioural, and environmental factors…that are generally accepted as requiring life-long treatment’’ (O’Brien, 1996). Therefore, the analysis presented below will not be unique to addiction, but will proceed as would the ethical evaluation of treatment and prevention of any illness. Central to the issue are the canons of autonomy, beneficence, nonmaleficence and justice (National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, 1979; Beauchamp and Childress, 1994). While each of these values are of extraordinary importance in modern bioethical thought, they are not absolute, universal or independent of each other. Autonomy implies ‘‘respect for the autonomous choices of other persons’’ (Beauchamp and Childress, 1994). It guarantees the right of competent persons to make informed decisions concerning their medical treatment. ‘‘Every human being of adult years and sound mind has a right to determine what shall be done with his own body…’’ (Schloendorff, 1914). Acknowledgment of autonomy fulfills the Kantian axiom that all persons have unconditional worth. However, even when claimed by a competent individual, autonomy is not unlimited, and may be curtailed should that person act in a manner obviously harmful (or potentially harmful) to others. The duty of nonmaleficence thrusts on the physician and, indeed, all persons in authority, the obligation not to inflict intentional harm: Primum non nocere. The Hippocratic Oath demands that physicians ‘‘will use treatment to help the sick according to my ability and judgment, but…never…to injure or wrong them.’’ The duty of beneficence requires more than avoiding the imposition of harm or interfering with autonomy. It requires caregivers to promote the individual’s well being. However, once again, this canon does not exist in and of itself, and it is not difficult to imagine situations when it might be incompatible with autonomy. The physician who follows a patient’s desires while certain that an alternate therapy is ‘superior’ confronts a conflict between autonomy and beneficence. Yet, in most circumstances autonomy will triumph and the individual will be left as the final arbiter of what is best. In such cases, acknowledging the patient’s autonomy (even if it leads to actions which others might believe detrimental) is held to constitute the highest order of beneficence. On a societal level, there is an innate tension between beneficence and nonmaleficence, for the individual good may be accompanied by significant harm to others.
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This tension gives rise to the fourth canon, that of justice. Who is to be granted the benefits of treatment? Who is to bear the burdens, whether these involve the denial of treatment or its imposition? It is not surprising that attempts to provide ‘‘fair, equitable, and appropriate distribution in society’’ (Beauchamp and Childress, 1994) will often conflict with the principles of autonomy, beneficence and nonmaleficence. The responsibility of physician, legislature and judge to secure justice for the individual may collide with their equally important duties to society. Any analyses that use these four principles of bioethics will have to balance the tensions among them.
4.1. Analogy between addiction and an infectious disease Although the pathogenesis of addiction is neither bacterial nor viral, the ability of a vaccine to modify its devastating effects could be examined in terms of an infectious disease model. Since legal scholars and judges often engage in generous simile and symbolism, it would not be surprising if future judicial opinions were written as if addiction had an infectious nature. In order to develop our analysis, let us consider the significant analogies between addiction and infectious disease. One such analogy between them is exemplified by the significant interaction of the individual with society as a whole in both infectious disease and addiction. What is done by a single addict can directly affect others: we may compare ‘transmissibility’ of addiction with that of an infectious disease. The individual infected with a bacterium or virus may be a temporary (if the disease is successfully treated or proves lethal) or permanent (if chronic) host for the infectious organism as it moves from one susceptible person to another. Similarly, although the mechanism differs from that in infectious disease, an addicted ‘host’ often sustains his or her disease by selling drugs to or sharing them with others, an act which spreads the affliction to the many. Moreover, just as infection with virus or bacterium may result in overgrowth of another living agent, addiction may cause co-infection, as when HIV or viral hepatitis result from injection drug abuse. While we may debate (and courts eventually decide) whether this analogy is valid, it is, as we shall see, a useful approach in analyzing some of the problems inherent in addiction as well as the ways society may elect to treat it. Complete acceptance of the analogy between addiction and infectious disease is not absolutely necessary for a thoughtful ethical and legal consideration of questions raised by the cocaine vaccine. The most important consideration is that of treatment and not mechanism of treatment. Cocaine addiction remains an overwhelmingly important public health concern. As
such, its treatment and prevention must be subject to the same approach as any other illness within the public health domain.
4.2. Infectious disease and the role of immunization Historically, one of the most successful public health measures that has been brought to bear in preventing infectious disease is that of immunization. Public health considerations offer a variety of reasons for immunizing some or all members of the population against infectious diseases. In general, we can consider the categories benefitted by immunization to be the individual and society as a whole. There is a spectrum of good accruing to each category depending on the nature of the particular disease under scrutiny. On one end of the spectrum is rabies, where the risks and benefits of immunization in the United States argue for treatment only after exposure, or possible exposure, to the virus. The likelihood of human-to-human transmission is insignificant; therefore, the goal of immunization is to prevent the indi6idual from contracting the disease. On the other end of the continuum lies smallpox where human-to-human transmission has been devastating throughout most of history. Protection by smallpox vaccination is exerted on several levels. First, it provides direct protection to the immunized individual. Second, the possibility of infecting non-immunized persons is small because of the immune status of most other members of society. Finally, the spread of infection by a few individuals who do not choose to be immunized is minimized by society’s ‘herd immunity’, a phenomenon resulting from the vaccination of the vast majority of its members. Smallpox vaccination epitomizes the goals of public health in the infectious disease arena: the disease no longer exists on earth. In between these two extremes of the spectrum lie infectious diseases such as hepatitis B. Here (at least until recently), immunization is designed both to protect the individual such as surgeon, anesthesiologist, or any other physician exposed to blood products, and a subset of the population, such as patients undergoing surgery. Recently, the importance of hepatitis B vaccination has been illustrated dramatically. Harpaz et al. (1996) described transmission of hepatitis B virus to several patients whose unimmunized surgeon carried the virus; in these cases, there was no evidence of inadequate infectious control. The consequences of hepatitis B are severe and the risks of immunization minimal. The ability of hepatitis B-immunization to protect both the health care worker and patient led Gerberding (1996) to suggest: Vaccination against hepatitis B in all susceptible health care providers should be a requirement for matriculation in professional school, and for those
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already in practice, vaccination should be a requirement for continued contact with patients. Note that the scope of immunization is not static. Knowledge brings change — the American Academy of Pediatrics now recommends universal immunization against hepatitis B (Hall, 1995). The preceding discussion has considered only the direct benefit of immunization, the prevention of disease. Even if immunization confers direct protection only on the individual, there will still be indirect benefits (e.g., economic and emotional) for many other members of society. In view of the above, why not institute universal mandatory immunization once a cocaine vaccine is available? There is ample legal support for the state’s application of police power when necessary to act in the interests of public health (Jacobson, 1905; Gostin, 1991, 1995b). However, just because society has this power does not mean that such an approach is ethically justified. The potential burdens of requiring that individuals who are neither addicted nor consider themselves to be at risk must be carefully evaluated. Certainly, any consideration of universal immunization will be modified should significant side effects become manifest during clinical testing. Furthermore, even in the absence of any medical risks, many believe that the state should not intrude into the private sphere unless there are compelling reasons to do so and no other means are available to attain its goals, no matter how beneficial these goals may be. Moreover, on a practical level, compulsory vaccination is not a panacea; indeed, because of individuals’ reactions against governmental mandates, it may conceivably help fewer individuals than would a voluntary approach. Nicholson (1996) has noted that voluntary (some European nations) diphtheria, pertussis and tetanus administration achieved a higher level of compliance than when immunization was mandated (United States). This may simply reflect some citizens’ resistance to compulsion and difficulties in enforcement in the United States. In any case, there are certainly a number of persuasive reasons not to initiate mandatory immunization with a cocaine vaccine. Society’s response to this question can be facilitated by the public health/infectious disease analogy proposed here. Indeed, the resulting arguments are not dissimilar to those which will arise when a safe and effective AIDS vaccine becomes available (Polizzi, 1994). In any analysis, we must remember that use of either immunotherapy (or, for that matter, pharmacotherapy) alone will not guarantee success in combating the disease of addiction (Chavkin, 1991). Psychosocial support, behavioral modification, after care and even changes in society must accompany any type of medication-related therapy.
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5. Summary: what happens tomorrow? A safe and effective cocaine vaccine still lies in the future. Nonetheless, a wise society must attempt to anticipate problems that will arise when the therapeutic and prophylactic benefits of such a vaccine become available. The loss of privacy and probable discrimination related to demonstrating a person’s antibody titer is significant, but not unique to the cocaine vaccine. Electronic data processing, a necessary concomitant of today’s medical practice, allows major invasions of patients’ confidentiality (Alpert, 1993; DeCrew, 1994; Gostin, 1995a). Maintaining confidentiality of a patient’s medical records or antibody status should not be brought about by abolishing computer technology or failing to institute novel and beneficial immunization practices. A far more productive approach will come from changes in the law and in society’s ethos which can uphold privacy in an equitable and reasonable fashion. While privacy concerns raised by the availability of a cocaine vaccine are part of the general problem of confidentiality created by today’s technology, the question of who is to be immunized against addiction has unique aspects. Although this particular mode of therapy may be new, the question of pharmacological therapy and addiction need not be analyzed de novo. The analogy between addiction and infectious disease offers a useful analytic tool. Fundamental to this approach is a societal decision that addiction is an illness that can be compared to any other disease. The aim of immunization is to treat, cure and prevent—not to punish. Voluntary treatment of competent adults, whether addicted or not, is similar to any medical therapy requested by such an individual; that it involves a novel approach to disease does not raise significant ethical difficulties. The same holds for immunization of minor children with the consent of their parents, although the need for minors’ assent may take on importance with their increasing age. Society currently allows alternatives to incarceration for persons convicted of certain crimes. Therapy directed towards behavioral modification, such as attendance at meetings of Alcoholics Anonymous or participation in Drivers’ Education is available to our courts. Some jurisdictions also allow pharmacological intervention such as methadone or disulfiram. Supervised naltrexone therapy is used by certain medical and legal licensing boards as an alternative to revocation of a professional license. In face of these precedents, it is not unreasonable to consider the addition of a cocaine vaccine to this list of treatment. If we are willing to accept that addiction possesses some of the attributes of an infectious disease, we may be able to entertain the possibility of using the cocaine vaccine in those who have not manifested the disease of
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addiction. Again, the requirement of competent informed consent will obviate major ethical difficulties. Finally, institution of a mandatory program of immunization for all members of society will raise the most significant questions. It is here that decisions may be facilitated by analogizing addiction and infectious disease. It is not the goal of this paper to provide a final and definitive answer. What has been suggested is an analytic approach based on treating addiction as a disease requiring prophylaxis before it occurs and treatment thereafter. The choices are not easy, and will require a delicate balancing in the face of conflicting benefits and burdens. Hopefully, the decisions will be made by an informed and compassionate society with a firm knowledge of the disease nature of addiction.
Acknowledgements I wish to express my appreciation to Cynthia B. Cohen, PhD, JD, David Gorelick, MD, PhD, Joel Egertson, MA, Richard A. Millstein, JD and Frank Vocci, PhD for their thoughtful review and helpful comments.
References Alpert, S., 1993. Smart cards, smarter policy. Medical records, privacy, and health care reform. Hastings Center Rep. 23, 13 – 23. Beauchamp, T., Childress, J.F., 1994. Principles of Biomedical Ethics, 4th ed. Oxford University Press, New York, Oxford. Carrera, M.R.A., Ashley, J.A., Parsons, L.H., Wirsching, P., Koob, G.F., Janda, K.D., 1995. Suppression of psychoactive effects of cocaine by active immunization. Nature 378, 727–730. Chavkin, W., 1991. Mandatory treatment for drug use during pregnancy. J. Am. Med. Assoc. 266, 1556–1561. Davis v. Berry et al. 216 F. 413, 416 (1914). DeCrew, J.W., 1994. Drug testing: balancing privacy and public safety. Hastings Center Rep. 24, 17–23. Drug Use Forecasting, 1994. 1993 Annual report on adult arrestees: drugs and crime in America’s cities. US Department of Justice, US Government Printing Office, Washington, DC. Fulco, C.E., Liverman, C.T., Earley, L.E. (Eds.), 1995. Development of Medications for the Treatment of Opiate and Cocaine Addictions: Issues for the Government and Private Sector, Chapter 1. Institute of Medicine, National Academy Press, Washington, DC. pp. 26 – 42. Gerberding, J.L., 1996. The infected health care provider (editorial). New Engl. J. Med. 334, 594–595. Ghent, J.F., 1995. Annotation: validity of statutes authorizing asexualization or sterilization of criminals or mental defectives. 53 A.L.R.3d 960. Gostin, L.O., 1991. Compulsory treatment for drug-dependent persons: justifications for a public health approach to drug dependency. Milbank Quart. 69, 561–593.
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Gostin, L.O., 1995a. Health information privacy. Cornell L. Rev. 80, 451 – 528. Gostin, L.O., 1995b. Tuberculosis and the power of the state: toward the development of rational standards for the review of compulsory public health powers. U. Chi. L. Sch. Roundtable 2, 219– 277. Hall, C.B., 1995. The recommended childhood immunization schedule of the United States. Pediatrics 95, 135 – 137. Harpaz, R., Von Seidlein, L., Averhoff, F.M., Tormey, M.P., Sinha, S.D., Kotsopoulou, K., Lambert, S.B., Robertson, B.H., Cherry, J.D., Shapiro, C.N., 1996. Transmission of hepatitis B virus to multiple patients from a surgeon without evidence of inadequate infection control. N. Engl. J. Med. 334, 549 – 554. Jacobson v. Massachusetts 197 U.S. 11 (1905). Kleber, H.D., 1985. Naltrexone. J. Subst. Abuse Treat. 2, 117–122. Kun, J.-M., 1996. Rejecting the adage ‘children should be seen and not heard’. Pace Law Rev. 16, 423 – 462. Leshner, A.I., 1996. Molecular mechanisms of cocaine addiction. New Engl. J. Med. 335, 128 – 129. Leukefeld, C.G., Tims, F.M., 1990. Compulsory treatment for drug abuse. Int. J. Addict. 25, 621 – 640. Marco, C.H., Marco, J.M., 1980. Antabuse: medication in exchange for a limited freedom — Is it legal?. Am. J. Law Med. 5, 295– 330. Mendelson, J.H., Mello, N.K., 1996. Management of cocaine abuse and dependence. New Engl. J. Med. 334, 965 – 972. National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research, OPRR Reports, National Institutes of Health, Bethesda, MD. Nicholson, R.H., 1996. U.K. moves toward compulsory vaccination. Hastings Center Rep. 20, 4. Nutt, D.J., 1996. Addiction: brain mechanisms and their treatment implications. Lancet 347, 31 – 36. O’Brien, C.P., 1996. Myths about the treatment of addiction. Lancet 347, 237 – 240. Olmsted v. United States, 277 U.S. 438, 478 (1928) (Brandeis, J., dissenting) Polizzi, C.M., 1994. A proposal for a federal AIDS immunization policy. J. Law Health 9, 1 – 40. Robinson v. California, 370 U.S. 660 (1962) Schloendorff v. The Society of the New York Hospital, 211 N.Y. 125, 129, 105 N.E. 92, 93 (1914). Self, D.W., 1995. Cocaine abuse takes a shot. Nature 378, 666–667. Smith, T.W., Butler, V.P. Jr., Haber, E., Fozzard, H., Marcus, F.I., Bremner, W.F., Schulman, I.C., Phillips, A., 1982. Treatment of life-threatening digitalis intoxication with digoxin-specific Fab fragments: experience in 26 cases. New Engl. J. Med. 307, 1357– 1362. Smith, T.W., Haber, E., Yeatman, L., Butler, V.P. Jr., 1976. Reversal of advanced digoxin intoxication with Fab fragments of digoxinspecific antibodies. New Engl. J. Med. 294, 797 – 800. Stern, C., 1996. California waging war on sexual predators; chemical castration law is state’s latest weapon. The Washington Post, September 24, page A3. Tarasoff v. Regents of the University of California, 551 P.2d 334, 340, 344 (1976) (en banc) Weinstein, S.P., Gottheil, E. E., Sterling, R.C., DeMaria, P.A. Jr., 1993. Long-term methadone maintenance treatment: some clinical examples. J. Subst. Abuse Treat. 10, 277 – 281.
Immunization for prevention and treatment of cocaine abuse: legal and ethical implications1 Peter J. Cohen Medications De6elopment Di6ision, National Institute on Drug Abuse, National Institutes of Health, Rock6ille, MD, USA Received 14 October 1996; accepted 21 May 1997
Abstract A cocaine vaccine, currently under investigation by several laboratories, would be an innovative and exciting means of treating and preventing cocaine addiction. However, an approved vaccine will raise at least two major areas of concern. (1) Loss of privacy: cocaine antibodies might be used as a marker to identify, penalize, and stigmatize vaccinated individuals. (2) Selection for vaccination: should immunization be voluntary or compelled; should immunization be restricted to addicts, to those at risk of addiction, or should it be universal; should immunization be used in children? I propose to analogize cocaine addiction to an infectious disease which poses a major public health problem. This approach can provide an ethical and legal foundation on which we may begin to formulate a societal approach to the use of the cocaine vaccine. © 1997 Elsevier Science Ireland Ltd. Keywords: Cocaine vaccine; Addiction therapy; Stigmatization and discrimination; Privacy and confidentiality; Law and ethics
1. Introduction Behind every silver lining is a cloud (Anon) Drug addiction remains a major public health problem (Fulco et al., 1995) in spite of extensive efforts devoted to its eradication. The identification of opioid receptors and elucidation of their pharmacology (Nutt, 1996) explains the success of intervention either by agonist (Weinstein et al., 1993) or antagonist (Kleber, 1985) administration. The molecular mechanisms of cocaine addiction, in contrast, are less clear (Mendelson and Mello, 1996), and pharmacological attempts to ameliorate addiction-associated craving and relapse have been far less successful. Currently ‘‘there are no 1 This manuscript is an expanded version of a presentation at the NIDA Symposium held during the 27th Annual Medical-Scientific Conference of the American Society of Addiction Medicine, April, 1996. The views and opinions expressed herein are those of the author and do not necessarily reflect those of the National Institute on Drug Abuse.
pharmacologic treatments for any aspect of cocaine addiction’’ (Leshner, 1996). In view of our incomplete knowledge of the specific site or sites involved in the production and maintenance of cocaine addiction, it would be useful to develop a means of inactivating the drug before it can gain access to the central nervous system. Immunology offers an exciting and innovative approach to such therapy. The use of immunology-based pharmacology in treating addiction would not be unique; for example, severe digitalis intoxication is amenable to therapy using specific antibodies (Smith et al., 1976, 1982). Immunopharmacology may have a significant role in treating and preventing cocaine addiction. It has recently been shown that rats may be actively immunized against cocaine (Carrera et al., 1995). Following immunization, the animals manifested an altered behavioral response to parenteral cocaine, thereby demonstrating an effective titer of cocaine antibodies which could bind to cocaine prior to its entrance into the central nervous system. This phenomenon set the stage for both treating and preventing cocaine addiction.
0376-8716/97/$17.00 © 1997 Elsevier Science Ireland Ltd. All rights reserved. PII S 0 3 7 6 - 8 7 1 6 ( 9 7 ) 0 0 0 7 5 - 6
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There may be significant advantages to instituting therapy which acts on the addictive drug directly rather than attempting to change the nature of the receptor(s), since these receptors are likely to have numerous other important functions. Hopefully, immunological therapy would not produce undesirable psychological or neurological side effects. Finally, it might involve only a few initial injections followed by periodic ‘booster’ injections (Self, 1995). Many studies will be required to prove the safety and efficacy of this approach. Among the questions to be answered are whether antibody levels will remain sufficiently high to block the action of all practicable doses of cocaine, and whether hypersensitivity reactions to cocaine will develop (Self, 1995). Furthermore, while antibody specificity is essential if cross-reactivity with local anesthetics is to be avoided, this attribute will also limit the utility of the vaccine since the actions of other stimulants (e.g., amphetamines) will remain unaffected. Finally, immunotherapy does not deal with any underlying behavioral pathology that may contribute to and potentiate the addiction. These are significant scientific questions which must be answered before there is any possibility of the cocaine vaccine’s acceptance into the armamentarium of addiction medicine. Nonetheless, if development were successful, such therapy would be a boon to society. However, science does not exist in a vacuum: scientific discoveries perturb society. As an example, the Human Genome Project will provide vast new knowledge with the potential for helping society; it also may lay the foundation for significant abuse such as discrimination and stigmatization. The silicon chip led to the computer, but also opened the door to a significant diminution of individual privacy. A similar dichotomy between benefits and burdens may be exhibited by the cocaine vaccine. Although its efficacy is yet to be demonstrated in human addicts, initial clinical studies are scheduled to begin by the end of this year. Thus, while approval by the Food and Drug Administration (FDA) is undoubtedly years in the future, it would be wise to address potential ethical and legal questions now. Postponement will only result in emotional debates after the vaccine has been accepted as part of medical practice. Representative of the need for advance planning are today’s technologies of assisted reproduction which arose without regulation or significant ethical analysis. A perfected vaccine could be used both to prevent and treat cocaine addiction. The vaccine will have no effects on the immunized individual except in the context of cocaine use. After ingesting cocaine, the immunized person will not experience a ‘high’, thus diminishing the likelihood of repeating the drug use. Relapse in the detoxified addict will not be associated with euphoria; without such re-enforcement, the behavior is unlikely to continue. What possible ethical or
legal problems could result from such an apparently beneficial methodology? The aim of this communication is to outline some of the inevitable ethical questions that will arise from the immunological approach to cocaine addiction. These questions will be posed and methods proposed for their analysis, but definitive answers will not be provided at this point. While it might be more satisfying to the reader were I to provide firm ‘truths’, such an absolutist approach would be inappropriate. For as society seeks to develop a consensus that will enable formulation of a policy, scientists, attorneys, bioethicists, specialists in addiction medicine and others will provide their expertise. Eventually, however, the final decision must be taken only after considered thought and debate by an informed public. This discussion will assume that the FDA might at some point approve a vaccine capable of predictably stimulating formation of cocaine-binding antibodies with a minimum of side effects. However, the legal and ethical analysis would require modification if significant adverse responses were observed. Peripheral issues such as lack of industrial interest because of perceived problems with litigation and lack of governmental indemnification for adverse effects will not be addressed. Finally, while this mode of therapy may engender certain unique problems (e.g., potentially intrusive attempts to detect antibodies not directed at an infectious agent) other ethical challenges do not present de novo (e.g., issues of coercion and confidentiality). In view of the major public health hazards of cocaine addiction, the fact that not all problems raised by this therapy are novel ought not preclude a comprehensive discussion of all aspects of this mode of therapy.
2. Potential for stigmatization The concept of privacy is prized in American society, although it is not specifically mentioned in the Constitution. Privacy implies that every person, by virtue of being a person, has the right to inviolate space within which he or she has ‘‘the right to be let alone—the most comprehensive of rights and the right most valued by civilized men’’ (Olmsted, 1928). This right makes axiomatic the requirement that information dealing with an individual’s health is not to be shared by health care professionals with others without informed and competent consent. However, neither our law nor social ethos considers the right to confidentiality to be absolute. An important judicial decision (Tarasoff, 1976) held that threats to other individuals must be balanced against claims of patient confidentiality. Should a patient reveal to a psychotherapist that he or she intends to inflict serious harm on another, the therapist must
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give warning. The California Supreme Court held that the therapist: incurs an obligation to use reasonable care to protect the intended victim against such danger. The discharge of this duty may require the therapist to…warn the intended victim or others likely to apprise the victim of the danger, to notify the police, or to take whatever other steps are reasonably necessary under the circumstances. The Tarasoff court extended its decision to infectious diseases: a doctor is liable to persons infected by his patient if he [sic] negligently fails to diagnose a contagious disease, or, having diagnosed the illness, fails to warn members of the patient’s family. Furthermore, numerous statutes require that certain communicable diseases be reported to appropriate public health authorities. As with communicable diseases, a cocaine vaccine will also raise questions of individual privacy. Unlike some (but not all) communicable diseases, the balancing between individual privacy and public welfare will have the added factor of the stigma ascribed to drug addiction by a sizable portion of society. The cocaine-binding antibody will be responsible for the beneficial effects of immunization. However, the presence of this antibody will also create a major ethical problem related to privacy, since it will be possible to detect it in the blood of immunized persons. Information concerning an immunized individual’s positive cocaine-antibody status (analogous to HIV-positivity) will be difficult to keep hidden, as it will appear in their medical records. This may lead to stigmatization and discrimination, for it will suggest that vaccinated individuals are cocaine addicts, or at least are ‘susceptible’ to addiction. Society will have to deal with legal and ethical considerations regarding privacy and prejudice in a vulnerable population, a situation similar to that which now accompanies disclosure of HIV-positivity. Parenthetically, this same issue would become relevant to the AIDS community if an HIV vaccine were perfected. The problems of confidentiality, however, are not unique to a cocaine vaccine. Methadone and disulfiram (Antabuse™) can be measured in blood and, if detected, can also subject individuals to discrimination. Furthermore, this ethical difficulty is not confined to the arena of addiction: medical records in general, once considered inviolate in terms of privacy, are subject to widespread dissemination. While the motive for such abrogation of confidentiality may represent the darker side of humanity (curiosity, greed, revenge, intrusion of
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an unauthorized attorney), modern medical practice frequently mandates that such data be made available to numerous health care professionals (Alpert, 1993) as well as insurance under/writers, managed care companies and state databases. Gostin (1995a) has forcefully addressed the tension between privacy and availability of medical information in modern medicine. If society wishes the benefits of comprehensive, accurate and portable medical records, and those of a cocaine vaccine, it must institute legal and behavioral changes that will preserve privacy and confidentiality. The law, both legislative and judicial, is one means by which ethical and moral imperatives may be translated into action making it possible for them to become a force to change society (Alpert, 1993; Gostin, 1995a). Federal statute provides that the ethical mandate of confidentiality be enforced for records of addicted patients—42 U.S.C. § 290ee-3 states: Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any drug abuse prevention function conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall [except within the Armed Forces or Veterans Administration, or when exempted by State laws dealing with child abuse or neglect] be confidential and be disclosed only for the purposes and under the circumstances expressly authorized [e.g., with consent, in a medical emergency, under court order]. While the law may be used to transform morals or ethics into action, it is equally true that law without ethics will be to no avail. An individual who has been deprived of privacy may certainly litigate on the basis of a confidentiality statute. However, litigation is long, costly and emotionally draining. A meaningful answer requires that our ethos undergo a change such that individual privacy becomes a prime value to every member of society.
3. Potential for coercion Once the safety and efficacy of the cocaine vaccine have been demonstrated, society will confront the inevitable question: who will be vaccinated? The answers comprise a continuum of possibilities ranging from voluntary vaccination of competent adults to universal and mandatory immunization.
3.1. Consenting adults and children Since this discussion assumes the vaccine to be both safe and effective, there should be few problems with its
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administration to competent consenting adults. The immunization of children brings us to a more controversial area. There is a consensus that parents have a major responsibility for the welfare of their children. Does this include the right to have their children immunized if they believe this treatment to be in these children’s best interests? Is a minor child’s age to be considered in requiring ‘assent’ in addition to parental consent? Kun (1996) provides an affirmative response; she has proposed that statutes giving ‘‘minors a substantial, although not exclusive, role in medical decisions would recognize that certain minors have the requisite decision-making capacity to play a role in their health care choices’’.
3.2. Con6icted criminals Further along the continuum we enter the criminal justice system and the conditions for probation and parole for those convicted of a crime. Courts may sentence convicted felons to probation; 18 U.S.C. § 3563(b)(10) allows the court to require that a defendant receiving probation: undergo available medical, psychiatric, or psychological treatment, including treatment for drug or alcohol dependency, as specified by the court, and remain in a specified institution if required for that purpose. Supervised release (parole), governed by 18 U.S.C. § 3583(d)(3), allows requirements ‘‘consistent with…any condition set forth as a discretionary condition of probation in §3563(b)…(10).’’ Thus, courts currently may offer alternatives (both behavioral and pharmacological) to incarceration, and may impose conditions for parole: these include community service, attendance at meetings of Alcoholics Anonymous, participation in methadone programs, and/or residence within a therapeutic community. Physicians and attorneys who have become addicted to opioids may be mandated to use naltrexone in order to maintain their licensure. Do the above considerations suggest that our courts should include cocaine immunization as a condition for probation among their judicial options? While the answer might appear obvious at first glance, the issue is complicated by the question of whether treatment with the cocaine vaccine would constitute cruel and unusual punishment forbidden by the Constitution’s Eighth Amendment. Even if it were not deemed ‘punishment’ (since one could argue that it is an alternati6e to punitive incarceration), there is still a significant element of coercion. Furthermore, there are limits to the conditions that are acceptable for probation or parole. For example, castration of sex offenders (the efficacy of which is controversial) is impermissible even if under-
taken on a ‘voluntary’ basis. Many courts have struck down statutes imposing castration as part of a prison sentence or as a condition of probation/parole, holding that the procedure violates the Eighth Amendment and fails to give due process (Ghent, 1995). As early as 1914 (Davis, 1914), a federal court declared of castration: The physical suffering may not be so great, but that is not the only test of cruel punishment; the humiliation, the degradation, the mental suffering are always present and known by all the public, and will follow [the defendant] wheresoever he may go. This belongs to the Dark Ages. Recent legislation in California mandating ‘chemical’ castration (by means of weekly injections of DepoProvera™) for ‘‘child molesters and other violent sexual predators’’ (Stern, 1996) will undoubtedly force our courts to address this issue again. In any case, one can argue that, unlike castration, the vaccine will have proven safety and efficacy, may have a finite duration of action and need not be accompanied by ‘humiliation and degradation’. Less extreme, but also a controversial pharmacological intervention, is the offer of disulfiram to defendants convicted of drunken driving as an alternative to jail. This practice has been criticized (Marco and Marco, 1980) largely on the basis of unquantified risks of disulfiram, many of which were related to ingestion of alcohol. Furthermore, the analysis should have balanced the risks of disulfiram with its benefits, i.e. lessening the significant direct harm of chronic abuse of alcohol as well as the likelihood of death of the alcoholic and innocent members of society should the impaired driving be continued. Informed and thoughtful bioethicists may differ in their response to judicial imposition of a cocaine vaccine in criminal cases. How the legal process answers the question of whether vaccination should be allowed, and, if so under what circumstances, will undoubtedly require considerable litigation, with the ultimate decision likely being rendered by the Supreme Court. If judicial discretion is extended to the cocaine vaccine, should use of this tool be restricted to those convicted of specific drug-related offenses? Or, since drug addiction is ‘endemic’ in those convicted of a wide variety of crimes (Drug Use Forecasting, 1994), should the vaccine be available for courts to use with all convicted persons?
3.3. Addicts who ha6e not committed a crime How may we use the cocaine vaccine when confronted with addicts who have not been involved in any criminal activity? While criminal law may permit immunization under specific circumstances, it cannot justify
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administration of the vaccine to those who have committed no criminal acts. Ci6il law is another matter: although the ‘status’ of addiction may not be made a crime (Robinson, 1962), the disease of addiction is often associated with behavior which poses a serious threat both to the individual and society. Reacting to the possibility of future harm, the Robinson court also held: In the interest of the general health or welfare of its inhabitants, a State might establish a program of compulsory treatment for those addicted to narcotics. Such a program of treatment might require periods of involuntary confinement. And penal sanctions might be imposed for failure to comply with established compulsory treatment procedures. Civil commitment has been used as a means of instituting compulsory treatment of drug addicts for over a quarter of a century (Leukefeld and Tims, 1990). The Federal Narcotic Addict Rehabilitation Act of 1966 (Public Law 89-793; 18 U.S.C. §§ 4251 – 4255) authorizes compulsory civil commitment and treatment, as do California and New York statutes. Federal and state civil commitment programs were in full operation from 1965 to 1975 at which time they were replaced by programs of community drug treatment (Leukefeld and Tims, 1990). Would not the use of a cocaine vaccine be far less coercive?
3.4. Non-addicted population Should the vaccine be used in the absence of addiction or criminal conviction, but when an individual (or population) is deemed to be ‘susceptible’ to addiction? Mandatory vaccination of ‘targeted’ populations outside the criminal justice system is fraught with potential for prejudice, discrimination and unfairness. As a result, this approach would face severe Constitutional challenge. Paradoxically, these problems would be obviated if society adopted the obvious and inevitable policy of mandatory universal vaccination. This will be examined in more depth in the next section which will also propose an analytic methodology. Suffice it to say at this point that universal immunization would also eliminate the problem of stigmatization: if everyone were antibody-positive, that status would no longer result in discrimination or prejudice against any one person!
4. The continuum of possibilities: a proposed analytic method The potential for stigmatization, discrimination, loss of privacy and coercion presents significant problems
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that society will confront once the vaccine becomes available. Before we can attempt to arrive at an ethical and legal consensus, we must agree on an analytic framework. Addiction is ‘‘a chronic medical disorder…in a category with other conditions that show a similar confluence of genetic, biological, behavioural, and environmental factors…that are generally accepted as requiring life-long treatment’’ (O’Brien, 1996). Therefore, the analysis presented below will not be unique to addiction, but will proceed as would the ethical evaluation of treatment and prevention of any illness. Central to the issue are the canons of autonomy, beneficence, nonmaleficence and justice (National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, 1979; Beauchamp and Childress, 1994). While each of these values are of extraordinary importance in modern bioethical thought, they are not absolute, universal or independent of each other. Autonomy implies ‘‘respect for the autonomous choices of other persons’’ (Beauchamp and Childress, 1994). It guarantees the right of competent persons to make informed decisions concerning their medical treatment. ‘‘Every human being of adult years and sound mind has a right to determine what shall be done with his own body…’’ (Schloendorff, 1914). Acknowledgment of autonomy fulfills the Kantian axiom that all persons have unconditional worth. However, even when claimed by a competent individual, autonomy is not unlimited, and may be curtailed should that person act in a manner obviously harmful (or potentially harmful) to others. The duty of nonmaleficence thrusts on the physician and, indeed, all persons in authority, the obligation not to inflict intentional harm: Primum non nocere. The Hippocratic Oath demands that physicians ‘‘will use treatment to help the sick according to my ability and judgment, but…never…to injure or wrong them.’’ The duty of beneficence requires more than avoiding the imposition of harm or interfering with autonomy. It requires caregivers to promote the individual’s well being. However, once again, this canon does not exist in and of itself, and it is not difficult to imagine situations when it might be incompatible with autonomy. The physician who follows a patient’s desires while certain that an alternate therapy is ‘superior’ confronts a conflict between autonomy and beneficence. Yet, in most circumstances autonomy will triumph and the individual will be left as the final arbiter of what is best. In such cases, acknowledging the patient’s autonomy (even if it leads to actions which others might believe detrimental) is held to constitute the highest order of beneficence. On a societal level, there is an innate tension between beneficence and nonmaleficence, for the individual good may be accompanied by significant harm to others.
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This tension gives rise to the fourth canon, that of justice. Who is to be granted the benefits of treatment? Who is to bear the burdens, whether these involve the denial of treatment or its imposition? It is not surprising that attempts to provide ‘‘fair, equitable, and appropriate distribution in society’’ (Beauchamp and Childress, 1994) will often conflict with the principles of autonomy, beneficence and nonmaleficence. The responsibility of physician, legislature and judge to secure justice for the individual may collide with their equally important duties to society. Any analyses that use these four principles of bioethics will have to balance the tensions among them.
4.1. Analogy between addiction and an infectious disease Although the pathogenesis of addiction is neither bacterial nor viral, the ability of a vaccine to modify its devastating effects could be examined in terms of an infectious disease model. Since legal scholars and judges often engage in generous simile and symbolism, it would not be surprising if future judicial opinions were written as if addiction had an infectious nature. In order to develop our analysis, let us consider the significant analogies between addiction and infectious disease. One such analogy between them is exemplified by the significant interaction of the individual with society as a whole in both infectious disease and addiction. What is done by a single addict can directly affect others: we may compare ‘transmissibility’ of addiction with that of an infectious disease. The individual infected with a bacterium or virus may be a temporary (if the disease is successfully treated or proves lethal) or permanent (if chronic) host for the infectious organism as it moves from one susceptible person to another. Similarly, although the mechanism differs from that in infectious disease, an addicted ‘host’ often sustains his or her disease by selling drugs to or sharing them with others, an act which spreads the affliction to the many. Moreover, just as infection with virus or bacterium may result in overgrowth of another living agent, addiction may cause co-infection, as when HIV or viral hepatitis result from injection drug abuse. While we may debate (and courts eventually decide) whether this analogy is valid, it is, as we shall see, a useful approach in analyzing some of the problems inherent in addiction as well as the ways society may elect to treat it. Complete acceptance of the analogy between addiction and infectious disease is not absolutely necessary for a thoughtful ethical and legal consideration of questions raised by the cocaine vaccine. The most important consideration is that of treatment and not mechanism of treatment. Cocaine addiction remains an overwhelmingly important public health concern. As
such, its treatment and prevention must be subject to the same approach as any other illness within the public health domain.
4.2. Infectious disease and the role of immunization Historically, one of the most successful public health measures that has been brought to bear in preventing infectious disease is that of immunization. Public health considerations offer a variety of reasons for immunizing some or all members of the population against infectious diseases. In general, we can consider the categories benefitted by immunization to be the individual and society as a whole. There is a spectrum of good accruing to each category depending on the nature of the particular disease under scrutiny. On one end of the spectrum is rabies, where the risks and benefits of immunization in the United States argue for treatment only after exposure, or possible exposure, to the virus. The likelihood of human-to-human transmission is insignificant; therefore, the goal of immunization is to prevent the indi6idual from contracting the disease. On the other end of the continuum lies smallpox where human-to-human transmission has been devastating throughout most of history. Protection by smallpox vaccination is exerted on several levels. First, it provides direct protection to the immunized individual. Second, the possibility of infecting non-immunized persons is small because of the immune status of most other members of society. Finally, the spread of infection by a few individuals who do not choose to be immunized is minimized by society’s ‘herd immunity’, a phenomenon resulting from the vaccination of the vast majority of its members. Smallpox vaccination epitomizes the goals of public health in the infectious disease arena: the disease no longer exists on earth. In between these two extremes of the spectrum lie infectious diseases such as hepatitis B. Here (at least until recently), immunization is designed both to protect the individual such as surgeon, anesthesiologist, or any other physician exposed to blood products, and a subset of the population, such as patients undergoing surgery. Recently, the importance of hepatitis B vaccination has been illustrated dramatically. Harpaz et al. (1996) described transmission of hepatitis B virus to several patients whose unimmunized surgeon carried the virus; in these cases, there was no evidence of inadequate infectious control. The consequences of hepatitis B are severe and the risks of immunization minimal. The ability of hepatitis B-immunization to protect both the health care worker and patient led Gerberding (1996) to suggest: Vaccination against hepatitis B in all susceptible health care providers should be a requirement for matriculation in professional school, and for those
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already in practice, vaccination should be a requirement for continued contact with patients. Note that the scope of immunization is not static. Knowledge brings change — the American Academy of Pediatrics now recommends universal immunization against hepatitis B (Hall, 1995). The preceding discussion has considered only the direct benefit of immunization, the prevention of disease. Even if immunization confers direct protection only on the individual, there will still be indirect benefits (e.g., economic and emotional) for many other members of society. In view of the above, why not institute universal mandatory immunization once a cocaine vaccine is available? There is ample legal support for the state’s application of police power when necessary to act in the interests of public health (Jacobson, 1905; Gostin, 1991, 1995b). However, just because society has this power does not mean that such an approach is ethically justified. The potential burdens of requiring that individuals who are neither addicted nor consider themselves to be at risk must be carefully evaluated. Certainly, any consideration of universal immunization will be modified should significant side effects become manifest during clinical testing. Furthermore, even in the absence of any medical risks, many believe that the state should not intrude into the private sphere unless there are compelling reasons to do so and no other means are available to attain its goals, no matter how beneficial these goals may be. Moreover, on a practical level, compulsory vaccination is not a panacea; indeed, because of individuals’ reactions against governmental mandates, it may conceivably help fewer individuals than would a voluntary approach. Nicholson (1996) has noted that voluntary (some European nations) diphtheria, pertussis and tetanus administration achieved a higher level of compliance than when immunization was mandated (United States). This may simply reflect some citizens’ resistance to compulsion and difficulties in enforcement in the United States. In any case, there are certainly a number of persuasive reasons not to initiate mandatory immunization with a cocaine vaccine. Society’s response to this question can be facilitated by the public health/infectious disease analogy proposed here. Indeed, the resulting arguments are not dissimilar to those which will arise when a safe and effective AIDS vaccine becomes available (Polizzi, 1994). In any analysis, we must remember that use of either immunotherapy (or, for that matter, pharmacotherapy) alone will not guarantee success in combating the disease of addiction (Chavkin, 1991). Psychosocial support, behavioral modification, after care and even changes in society must accompany any type of medication-related therapy.
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5. Summary: what happens tomorrow? A safe and effective cocaine vaccine still lies in the future. Nonetheless, a wise society must attempt to anticipate problems that will arise when the therapeutic and prophylactic benefits of such a vaccine become available. The loss of privacy and probable discrimination related to demonstrating a person’s antibody titer is significant, but not unique to the cocaine vaccine. Electronic data processing, a necessary concomitant of today’s medical practice, allows major invasions of patients’ confidentiality (Alpert, 1993; DeCrew, 1994; Gostin, 1995a). Maintaining confidentiality of a patient’s medical records or antibody status should not be brought about by abolishing computer technology or failing to institute novel and beneficial immunization practices. A far more productive approach will come from changes in the law and in society’s ethos which can uphold privacy in an equitable and reasonable fashion. While privacy concerns raised by the availability of a cocaine vaccine are part of the general problem of confidentiality created by today’s technology, the question of who is to be immunized against addiction has unique aspects. Although this particular mode of therapy may be new, the question of pharmacological therapy and addiction need not be analyzed de novo. The analogy between addiction and infectious disease offers a useful analytic tool. Fundamental to this approach is a societal decision that addiction is an illness that can be compared to any other disease. The aim of immunization is to treat, cure and prevent—not to punish. Voluntary treatment of competent adults, whether addicted or not, is similar to any medical therapy requested by such an individual; that it involves a novel approach to disease does not raise significant ethical difficulties. The same holds for immunization of minor children with the consent of their parents, although the need for minors’ assent may take on importance with their increasing age. Society currently allows alternatives to incarceration for persons convicted of certain crimes. Therapy directed towards behavioral modification, such as attendance at meetings of Alcoholics Anonymous or participation in Drivers’ Education is available to our courts. Some jurisdictions also allow pharmacological intervention such as methadone or disulfiram. Supervised naltrexone therapy is used by certain medical and legal licensing boards as an alternative to revocation of a professional license. In face of these precedents, it is not unreasonable to consider the addition of a cocaine vaccine to this list of treatment. If we are willing to accept that addiction possesses some of the attributes of an infectious disease, we may be able to entertain the possibility of using the cocaine vaccine in those who have not manifested the disease of
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addiction. Again, the requirement of competent informed consent will obviate major ethical difficulties. Finally, institution of a mandatory program of immunization for all members of society will raise the most significant questions. It is here that decisions may be facilitated by analogizing addiction and infectious disease. It is not the goal of this paper to provide a final and definitive answer. What has been suggested is an analytic approach based on treating addiction as a disease requiring prophylaxis before it occurs and treatment thereafter. The choices are not easy, and will require a delicate balancing in the face of conflicting benefits and burdens. Hopefully, the decisions will be made by an informed and compassionate society with a firm knowledge of the disease nature of addiction.
Acknowledgements I wish to express my appreciation to Cynthia B. Cohen, PhD, JD, David Gorelick, MD, PhD, Joel Egertson, MA, Richard A. Millstein, JD and Frank Vocci, PhD for their thoughtful review and helpful comments.
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