New Treatments for Addiction Behavioral, Ethical, Legal, and Social Questions (2004) / Chapter Skim
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Appendix I: Vaccines and Immunotherapies to Control Addiction in Minors: The Legal Framework
Appendix I: Vaccines and Immunotherapies to Control Addiction in Minors: The Legal Framework
Pages 276-299
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From page 276... ...
Background Researchers have now developed drug addiction immunotherapies shown to curb the "high" of controlled substances such as PCP (phencyclidine) , cocaine, alcohol, and nicotine.
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From page 277... ...
More precisely, it deals with the subset of autonomy and consent issues that become relevant when authority figures seek to administer vaccines designed to prevent or control nicotine, alcohol, and drug abuse addiction in minors. No constitutional or common law right to use addictive substances exists,3 and such use may well be deemed illegal under state or federal law,4 but individuals have constitutional and common law protections when it comes to others' attempts to interfere with their bodily integrity to circumvent addiction.5 When anyone seeks to impose therapy on another regardless of consent in the name of public health, protection of third parties, crime prevention purposes -- or indeed in that person's own purported best interests -- the law will respect the targeted individual's right to refuse treatment unless very strong societal interests are found to justify trumping that person's autonomy.
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From page 278... ...
Addiction immunotherapies reduce chemical dependency on addictive substances and can be administered in two different ways: as either active or passive immunotherapy. 6See statutes cited in Hartman (2002)
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In lay terms, active immunotherapies theoretically make it harder for a user to get a "buzz" from addictive substances. However, substance abusers may be able to override the therapeutic blockade by ingesting ever-larger doses of the agent against which they have been immunized.
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From page 280... ...
In this respect, many immunotherapies pose merely an obstacle, not an insurmountable barrier, to addiction and could precipitate even more serious health problems -- even death -- for substance abusers. When an authority figure seeks to impose immunotherapy on a minor, the potentially lengthy duration of its blockading effect presents serious ethical and legal questions related to the young person's autonomy and privacy.
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From page 281... ...
This right of personal integrity and medical self-determination is near absolute in the eyes of the common law, and health lawyers and ethicists often assert -- with strong legal justification -- that an informed and competent person can voluntarily refuse consent to medical treatment for good reason, bad reason, or no reason at all. When competency or voluntariness is compromised, as can happen in circumstances ranging from minority 13Drug addiction prevention programs could target vulnerable populations, such as people in lower-income communities, minorities, people with a family history of drug abuse, and minors, among others.
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From page 282... ...
Thus, for example, persons with infectious tuberculosis who are noncompliant with antibiotic therapy have been quarantined for the purpose of treatment,17 and military service personnel slated to be deployed to Kuwait during Operation Desert Storm were threatened with court martial for refusing consent to be vaccinated against chemical and biological weapons.18 Similarly, incarcerated prisoners are not permitted to manipulate prison discipline by threatening to refuse consent for life-saving treatment (e.g., renal dialysis) as a weapon to secure transfer to a less restrictive prison environment.19 As a general rule, however, a competent individual cannot be compelled to undergo medical treatment against his or her wishes.
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From page 283... ...
The same ethical -- and highly pragmatic -- principle of respect for an adolescent's right to have a say in what happens to his or her body applies when it comes to securing his or her assent to any medical treatment.20 Moreover, emancipated minors have the legal right to make their own medical decisions regardless of age,21 the Supreme Court has recognized a minor's right to obtain contraceptives,22 and in some states a young woman who meets the definition of a mature minor has a statutory right to undergo an abortion without parental consent using a judicial bypass procedure, notwithstanding her lack of either majority or emancipation.23 These statutory exceptions to the common law rule that parents make medical decisions for children reinforce the point that an adolescent's rights are entitled to respect and that securing an adolescent's assent may be essential to effective medical treatment. 20 In re Green, 292 A
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From page 284... ...
. The state intervenes in its parens patriae role when alerted to situations where the parents' medical decisions have potential to cause irreparable harm to children's health and welfare.29 Thus when Jehovah's Witness parents refuse to consent to life-saving blood transfusions for their minor children, the state can petition for a court order permitting it to assume guardianship status for the limited purpose of consenting to medically urgent blood transfusions.30 Similarly, when Massachusetts parents refused to authorize chemotherapy for their 2-year-old son suffering from 24Prince v.
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From page 285... ...
She therefore refused consent for the son's operation. The New York Court of Appeals ruled that the state could intervene in such circumstances, acting in the child's best interests, notwithstanding that a child's life might not be in imminent danger were a particular procedure not performed at that time.34 Most courts, however, have declined to intervene in nonlifethreatening cases, especially when a parent's idiosyncratic medical aversions have been so inculcated in his offspring as to promote the child's "distrust and dread of" the procedure."35 In theory the child will be free to make his or her own medical decisions at the age of majority so long as no irreparable harm is sustained in the interim.
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From page 286... ...
Since childhood immunotherapy with relatively permanent effects might preclude adult choices about experiencing the pleasurable aspects of moderate alcohol intake, the legal, ethical, and political calculus about condoning parental authority in this area is less certain. The case for parent's authority to give consent for their children's immunotherapy, which has a more or less long-term impact on the children's 36On mandatory PKU testing of newborns, see, for example, Ma.
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From page 287... ...
. Such treatment would presumptively be considered within the customary standard of care and thus medically necessary and so should constitute a reimbursable expenditure for health insurance purposes.40 The Supreme Court has gone so far as to recognize the power of parents to commit their children to mental institutions for evaluation and treatment provided that appropriate statutory procedural safeguards for the minors have been observed.41 Immunotherapy falls into the category of parental decision making involved with shorter-term treatment for a child's already-diagnosed substance abuse, such as heroin or cocaine addiction.
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From page 288... ...
Further, female genital mutilation has been condemned as a human rights violation globally under a United Nations resolution.43 Parental authorization for sterilizing minor incompetents "in their own best interests" has also generated stiff legal resistance under Constitutional principles, for reasons related to the child's fundamental rights concerning reproduction and sexual privacy.44 This final grouping of parental improvement choices includes a more controversial subcategory of elective medical enhancements for children whose parents simply seek to upgrade characteristics otherwise deemed by society to be well within the range of normal. This subcategory of parental treatment decisions includes authorization for such procedures as 42Criminalization of Female Genital Mutilation Act, P
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From page 289... ...
EXPERIMENTAL USE OF IMMUNOTHERAPIES FOR ADDICTION The legal status of administering addiction immunotherapies is even more complex at the present time than the law's approach to administering FDA-approved medications because many immunotherapies are still in experimental stages.46 For example NicVax, an investigational vaccine to prevent and treat nicotine addiction, is currently the subject of European Phase I/II (preliminary safety and efficacy) clinical trials.47 Children's participation in clinical trials of experimental drugs, of particular concern for the purposes of this appendix (Labson, 2002)
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From page 290... ...
. The prospect of exposing minors to immunotherapy with the potential for unknown long-term effects, which has not yet been proven safe and effective enough to justify its therapeutic use among adults, raises the kind of daunting legal and ethical questions that should probably preclude experimental use of drugs to control addictions in all but the most compelling of circumstances (Grodin and Glantz, 1994)
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From page 291... ...
In order for the state to establish a universal vaccination program, however, the state interest would need to be extremely strong in order to outweigh the autonomy rights of individual citizens.53 For example, universal smallpox vaccination programs were condoned by the Supreme Court at the turn of the last 53 Jacobson v. Massachusetts, 197 U.S.
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From page 292... ...
the public health."54 One could question whether the court would rule the same way today, especially in light of the public's recent lukewarm response to smallpox vaccination regimens when faced with the threat of biological terrorism post-9/11. Where drug addiction immunotherapies are concerned, the nature of the state's interest differs from its interest in traditional universal vaccination for public health reasons.
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From page 293... ...
Congress has intervened to protect the human subjects of clinical trials, and the Common Rule will clearly protect adult prisoners and incarcerated juveniles during the experimental phases of drug addiction immunotherapies. Although Congress has not acted in similar paternalistic fashion with regard to FDA-approved treatments in prison populations, the case for a protective approach to "mandatory" drug treatment for prisoners seems equally compelling.
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The male equivalent of the Norplant controversy has erupted over criminal punishment mandating medical procedures to alter the male sex drive chemically. In 1996, California enacted legislation permitting a 61Skinner v.
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From page 295... ...
However, the necessarily invasive nature of immunotherapies and their lengthy duration suggest that the courts might treat coerced administration of such immunotherapies in a similarly strict manner. When criminal defendants and prisoners are forced, or even strongly exhorted, to undergo sterilization, use contraceptives, or receive drug addiction immunotherapies as a condition for more lenient treatment, the voluntariness of an individual's informed consent is arguably compromised.67 Educational Institutions Schools have obvious reasons for promoting drug-free environments.
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From page 296... ...
Although certain schools may be targets for those seeking to administer drug addiction immunotherapies, the choice of who should actually receive immunotherapy in a school will most often be deferred to parents by analogy to the Ritalin cases, because -- as previously discussed -- minors are generally deemed legally incapable of giving their own informed consent to medical procedures. 69 Vernonia School Disrict 475 v.
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An analysis of potential criminal liability of HIV infected pregnant women in the context of mandated drug therapy. Drake Law Review, 50(2)
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From page 298... ...
. Autonomy and informed consent in medical decisionmaking: Toward a new self-fulfilling prophecy.
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From page 299... ...
Wake Forest Law Review, 34, 671-714. Mushlin, M., Kramer, D.T., and Gobert, J.J.
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