Immunization for prevention and treatment of cocaine abuse: legal and ethical implications1
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 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, Smith et al., 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.
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.
Section snippets
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
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.
The continuum of possibilities: a proposed analytic method
The potential for stigmatization, discrimination, loss of privacy and coercion presents significant problems 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
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'
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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2002, LancetCitation Excerpt :First, children would be vaccinated at the request of their parents because, as minors, they are not legally able to consent. Since parents already make choices on behalf of their children that affect their lives as adults (eg, their diet and education), some will no doubt argue that immunisation against nicotine is another decision that parents have the right to make.24 This is likely to be contested, especially by adolescents who resist parental wishes.
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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.