Vaccines and Immunotherapies to Control Addiction in Minors: The Legal Framework
Frances H. Miller and Kaley Klanica
Many sectors of society face the challenge of fighting substance addictions. Health and life insurance companies promote healthier life-styles by offering incentives for their subscribers to remain or become smoke-free. Individuals enter rehabilitation clinics every day hoping to fight their addictions for their own personal health and well-being. Federal and state governments attempt to curb addiction rates for public health reasons and to prevent patterns of crime and poverty. Prisons strive to rehabilitate addicted inmates, hoping to offer them a good shot at staying clean once they leave the prison walls, and schools fight for the drug-free environments needed for students to thrive.
Perhaps those most concerned about drug addiction, especially drug addiction among minors, are parents who struggle to keep their children resistant to the peer and other societal pressures influencing them to use addictive substances recreationally. Adolescence is a dangerous passage for children to navigate safely, and this appendix focuses on the legal problems associated with administering immunotherapies intended to control addiction in the young.
Researchers have now developed drug addiction immunotherapies shown to curb the “high” of controlled substances such as PCP (phencyclidine), cocaine, alcohol, and nicotine. This appendix necessarily general-
izes the wide variety of these immunotherapies throughout much of the discussion, but social, legal, and ethical questions can obviously hinge on the nature, legality, and public consequences of the particular addiction.
Legal problems associated with immunizing human beings (including minors) against addictions generally fall into two broad categories, once the ethical, scientific, and policy hurdles of deciding whether these kinds of immunotherapies should be available at all have been cleared. The first grouping of issues involves the requirement for a patient’s informed consent to any kind of treatment, including immunotherapy.1 The second concerns liability for any injuries the patient sustains as a consequence of having been immunized.2 This appendix concentrates on the consent problem presented when children are to be given immunotherapy, not the liability issue. 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.
This means that the law generally acknowledges a competent adult’s right to decline therapy to treat an established addiction or to refuse vaccination to prevent one. But the legal situation is far more complicated when the patient is a minor, particularly one on whom the parent or another authority figure seeks to impose immunotherapy, as this appendix
will explore. Parents are generally deemed to be the appropriate medical decision makers for their minor children, although some state statutes specifically authorize adolescent consent to substance abuse treatment with or without parental concurrence.6 Administering immunotherapy to a nonconsenting adolescent pits the autonomy interest of the minor against the parent’s countervailing determination of that child’s best interests. The reverse legal dilemma can also occur, as when a minor seeks therapy—such as birth control—but the adolescent does not want to inform the parent about his or her sexual activity or when the parent refuses to authorize the treatment.7
Whose interests will prevail in parent-child disagreements about undergoing immunotherapy cannot be predicted with certainty for, as with virtually all legal questions, the answer depends on the underlying facts of the particular situation. How old is the child? What has been the history of the parent-child or other relevant authority figure relationship? How imminent is the threatened harm? How well established is the proposed therapy? How invasive is it? How permanent are the effects of treatment and of nontreatment? All of these factors must be weighed in determining whether a parent or other party in loco parentis has legal authority to make decisions about immunotherapy “for” an individual child or whether indeed that child might have the legal capacity to make such decisions on his or her own.
Generally speaking, the younger the child, the more imminent the threatened harm, and the more short lived the effects of the vaccine, the more likely the courts will uphold parental choices about administering immunotherapy to their offspring, notwithstanding a child’s lack of specific assent. Conversely, the older the adolescent, the more remote the perceived harm, and the longer lasting the effects of the treatment, the more likely it is that courts will give weight to a minor’s refusal to assent to immunotherapy in the face of parental pressure to undergo it.
Types of Immunotherapy
At first glance, drug addiction vaccines seem promising and attractive for short-circuiting addictions in minors before they get the chance to take hold. The addictive nature of potentially harmful—if not deadly—substances diminishes significantly after this kind of immunotherapy takes effect. Addiction immunotherapies reduce chemical dependency on addictive substances and can be administered in two different ways: as either active or passive immunotherapy.
Active immunization works like a vaccine by stimulating an antibody response from the recipient’s own immune system (Pentel, this volume). Passive immunotherapies use animal antibodies and are administered via a two-step process. An animal is vaccinated to produce the relevant antibodies; those antibodies are extracted and purified and then administered to the target recipient. These addiction immunotherapies do not become effective instantaneously. They can require multiple injections over several weeks and several months to reach full strength.
Both active and passive immunotherapy typically last 3 to 6 months after achieving full efficacy, but booster shots can be administered to increase this duration (Pentel, this volume). In theory, addictions will not take hold so long as the vaccine remains effective. If the addiction is already established, cessation theoretically becomes exponentially easier for a vaccinated person. Once an addiction’s hold no longer saps a person’s will, the focus of substance abuse prevention can switch to peer pressure, social attitudes, lack of education, and other social factors that can promote substance abuse and antisocial behavior. Although these pressures are still daunting enough hurdles to surmount, especially for adolescents, who are more likely than adults to be influenced by their peers to use addictive substances, they pale in comparison with the gargantuan task of overcoming established addictions.
The relatively long-term effect of drug addiction immunotherapies presents a particularly appealing prospect. The need for ongoing patient compliance with addiction therapy—in populations that arguably pose a special challenge for conformity to treatment regimes8—and the financial cost of repetitive therapeutic services are reduced significantly as the duration of immunotherapy effectiveness increases. Recipients of active or passive immunotherapies have to see their caregivers less often than do recipients of more traditional addiction therapy.
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. These megadoses can prove even more dangerous to abusers than taking the substance without medically induced immunity. This potential for “swamping” the blockade effect of immunotherapies by upping the amount
ingested particularly troubles parents who might otherwise attempt to prevent addiction by immunizing their children.
For example, a heroin-immunized adolescent could seek to overcome the vaccine-created euphoria barrier by simply countering it with an even larger dose of heroin. So could adolescents unaware that they had been immunized. Moreover, although immunotherapy’s current efficacy decreases within 3 to 6 months postvaccination (Pentel, this volume), previously immunized users whose efficacy has expired might nonetheless continue taking higher doses in the mistaken belief they were still necessary to achieve the desired euphoric effect. A user’s ignorance about the dosage required to overcome the blocking effect, as well as uncertainty about the length of immunotherapy effectiveness, could lead to fatal consequences. 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. For example, many of these vaccines will leave permanent biological tracers in recipients’ bodies that could be detectable years later by employers, medical providers, and insurance providers, to name a few. If employers can identify workers previously targeted as likely to become addicted to a controlled substance, the potential for workplace discrimination exists,9 notwithstanding the medical privacy protections of the Health Insurance Portability and Accountability Act (HIPAA).10 HIPAA’s medical privacy requirements do not apply to employers and employment records per se, but they do apply to employers in their capacity as “covered entities” if they administer or maintain employer-sponsored health insurance programs within the meaning of the federal ERISA (Employee Retirement Income Security Act) legislation governing employer-sponsored “welfare benefit plans.”11 The Americans with Disabilities Act12 and other antidiscrimination statutes presumptively offer after-the-fact remedies for workplace discrimination, but the uncertain-
As employers gain more ability to test regarding particular health concerns, the potential for employee discrimination based on medical status—potential or actual—increases. See, e.g., Norman-Bloodsaw v. Lawrence Berkeley Laboratory, 135 F. 3d 1260 (9th Cir 1998) (employers tested certain employees’ blood for syphilis, pregnancy, and sickle cell trait without their consent).
P. L. No. 104-191, 110 Stat. 1936 (1996).
45 C.F.R. 160.102, 160.103; see also http://www.cms.hhs.gov/hipaa/hipaa2/support/tools/decisionsupport/default.asp.
42 U.S.C.A. § 12101 (2003).
ties of litigation are a poor substitute for forestalling employment abuse in the first place.
Although drug addiction immunotherapies offer real promise for addiction prevention programs, their indiscriminate use has undeniable capacity to threaten personal autonomy and privacy.13 Competent and fully informed adults who voluntarily seek to protect themselves from addiction by electing to undergo immunotherapy present society with few legal questions. The lawyer’s antennae rise, however, when more vulnerable populations, such as prisoners, mental patients, or minors, are pressured to undergo immunotherapies with potentially long-lasting effects. Such “persuasion” is especially worrisome when the recipient is not currently in thrall to a deleterious substance but merely predicted to be at high risk for future addiction.
THE MEDICAL DECISION-MAKING PROCESS
Adults as Their Own Medical Decision Makers
To analyze the legal and ethical issues associated with giving minors immunotherapy to forestall addictive behavior, the way the law views the making of medical choices in general must be understood. Then special issues raised by medical decision making for minors can be examined in more detail. The common law’s deep respect for personal autonomy remains the core principle underlying legal, ethical, and scholarly insistence that individuals should have the right to control what happens to their own bodies (Jones, 1990). U.S. jurisprudence proceeds from the assumption that individuals have the right to be left alone so long as their actions do not infringe on the rights of others. The law of informed consent on this side of the Atlantic (as contrasted with Continental jurisprudence, which is more deferential to the supremacy of the state) has consistently reflected the principle of personal autonomy throughout the course of its evolution during the 20th and 21st centuries.
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
to senility to incarceration,14 or if the individual lacks material information at the time a medical decision is made,15 the legal analysis gets trickier.16 Nonetheless, the law’s rock bottom respect for personal autonomy still dominates the legal discourse about informed consent in the United States.
An individual’s right to self-determination with regard to medical treatment may be overridden only for the most compelling of circumstances, as can be the case when the public’s health would otherwise be seriously jeopardized. 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.
Involvement of Minors in Medical Decision Making
The law presumes that children under the age of 14 lack the capacity to give meaningful consent to medical treatment on their own because their judgment and ability to comprehend short-term implications and the long-range medical consequences of illness and therapy have not yet matured (Rosato, 2002). For adolescents—minors between the ages of 14 and 18—the legal situation is more complicated (Hartman, 2000; Hawkins, 1996; Scott, 2000). Their assent to treatment, notwithstanding any legal disability with respect to capacity, may be essential to accomplish any therapy that requires their cooperation. In one widely-reported case, Billy Best, a 16-year old Massachusetts boy diagnosed with Hodgkin’s disease, ran away from home after five sessions of a projected longer course of chemotherapy at Boston’s Dana Farber Cancer Center. He had pleaded with his parents to let him forego the incapacitating treatments, but
doctors had said that without the chemotherapy Billy would die in little more than a year. Fearful that their son would not survive without further chemotherapy, Billy’s parents told him in essence that he had no choice in the matter—he had to submit.
Billy promptly went missing, until his increasingly frantic parents and his doctors pledged publicly that they would not force him to undergo further chemotherapy without his consent. He did finally come back home after spending more than 3 weeks in Texas and then worked with his parents and caregivers to devise an alternative course of therapy for his disease. Billy was included as a full participant in devising his medical protocol, and in due course assented to, and did, comply with it (Negri, 1995; Knox, 1995). Five years later, in 2001, he was reported to be healthy and cancer-free, “living the snowboarder’s life” in Vail, Colorado (Lasalandra, 2001; Hart, 1999).
Billy Best’s case is instructive because it illustrates graphically the dire consequences that can ensue if an adolescent’s wishes are ignored in the consent process for medical procedures requiring their cooperation. 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.
In re Green, 292 A. 2d 387 (Pa. 1972) (Jehovah’s Witness mother of a 16-year-old boy with 94 percent curvature of the spine who was unable to stand or ambulate because his spine had collapsed refused consent for a spinal fusion operation for him).
An emancipated minor is generally defined as one who has married, enlisted in the armed forces, or become self-supporting below the age of majority. Emancipation ends the parents’ duty of support and confers on the minor those decision-making capabilities of adults. See, e.g., Parker v. Stage, 371 N.E. 2d 513 (N.Y. 1977).
Carey v. Population Services International, 431 U.S. 678 (1977).
Wicklund v. Lambert, 979 F. Supp. 1285 (D. Mont. 1997); Laws Requiring Parental Consent or Notification for Minors’ Abortion, available at http://www.plannedparenthood.org/LIBRARY/ABORTION/StateLaws.html.
Parents as Medical Decision Makers for Their Children
The parent-child relationship has always been deemed near sacrosanct in the eyes of the law. In the words of the Supreme Court, “It is cardinal with us that the custody, care and nurture of the child reside first in the parents, whose primary function and freedom include preparations for obligations the state can neither supply nor hinder.”24 Parents are presumed to act in the best interests of their children, and the law interferes with their right to make decisions about their minor offspring only in the most compelling of circumstances. Thus the parent or parents with custody can generally dictate where, for example, their children live, what kind of food they will eat, what kind of discipline they will be subjected to,25 what kind of education they will get,26 and the religion—if any—in which their children will be raised (Dwyer, 1994). They can also make medical decisions for their children, usually free from state interference (Holder, 1985).27
When children are deemed in need of care and protection concerning the choices their parents (or others) make for them, however, the state can—and will—intervene in the parent-child relationship. Again in the words of the Supreme Court, parental power “may be subject to limitation … if it appears that parental decisions will jeopardize the health and safety of the child.”28 Feinberg (1980) eloquently states the rationale for state intervention as follows: “Children are not legally capable of defending their own future interest against present infringement by their parents, so that task must be performed for them, usually by the state” (p. 124).
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
a highly curable form of Hodgkin’s disease, opting for what they termed “quality over quantity” of life (and treatment with laetrile) for him, the state sought and received a care and protection order—albeit too late to prevent the parents from fleeing to Mexico, where the child died relatively soon thereafter.31 Finally, when Christian Scientist parents have refused permission for life-saving medical treatment for their minor children, courts have permitted the state acting in parens patriae to order medically necessary therapy for the youngsters.32 Moreover, the state has prosecuted Christian Scientist parents whose child died after their refusal to authorize medical care for him.33
Parental authority to make medical decisions for their minor offspring is not, however, necessarily limited to those choices that the state considers immediately life-threatening to the child. In a 1970 case a 15-year-old New York boy suffered from von Recklinghausen’s disease, which had massively disfigured the side of his face and neck. The surgery his doctors advocated could have improved both his facial structure and appearance, and therefore his psyche, but it would have necessitated blood transfusions, which his mother’s religious beliefs prohibited. 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 nonlife-threatening 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.
Three Kinds of Medical Decisions Parents Make for Children
Parents possess inherent authority to make three general types of medical decisions for their children: protective decisions, therapeutic ones, and medical choices intended to enhance the child’s natural physical and mental capabilities or presumed attractiveness. Deciding to administer addiction immunotherapy to minors can be analyzed to fit into any of these categories.
“Protective” Medical Decisions
The first of these decisional categories encompasses parental control over those medical decisions related to routine—or even somewhat unusual—preventive or protective measures for the child. This permits parents to authorize medical personnel to administer the testing36 and immunizations37 generally deemed requisite for their offspring from a public health point of view.38 It also allows them to choose relatively unorthodox diets or exercise programs for their children or to take them to routine chiropractor or acupuncture visits as preventive measures (DeMarco, 2002). Immunizing a child against addiction would not—at least not yet—qualify as such a routine protective measure because the therapies themselves are still in the experimental stages. If, however, their safety and efficacy were satisfactorily established for children and their use in adult populations became widespread, parents might well seek to protect their offspring by immunizing them.
Given the speed with which cigarette smoking has fallen from grace as an acceptable social activity now that it and a wide variety of life-threatening and other illnesses have been scientifically linked, one can well envision the day (assuming a permanent vaccine becomes available) when childhood vaccination against nicotine addiction could be as routine as vaccination against measles. Whether vaccination against, for example, alcohol addiction could achieve similar “routine” status raises other issues altogether. 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
ability to experience the chemical high produced by controlled substances, lies somewhere in between those two situations.
“Therapeutic” Medical Decisions
Parents have authority to make decisions about testing and therapy for their children’s existing medical problems as well. This enables parents to authorize treatment for such routine ailments as strep throat, broken limbs, and urinary tract infections.39 In fact, should they fail to authorize treatment when their child’s health is seriously threatened, the state would presumably intervene to exercise the consent prerogative in their place. This category would also encompass parental authorization for more unusual therapies, such as administering human growth hormone (hGH) to increase the height of hormone-deficient children who are regarded as abnormally short by the medical profession (American Academy of Pediatrics, 1997). 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. A child in the throes of addiction presents a legitimate case for medical intervention, and a parent’s authority to consent to appropriate treatment—assuming that the immunotherapy in question has received approval by the Food and Drug Administration (FDA)—seems strong. Moreover, to the extent that immunotherapy becomes the medical standard of care for treating addiction among adolescents, one could envision the state intervening in its parens patriae role to protect a severely addicted child whose parents refused consent for the child receiving it, making analogies to the Christian Scientist parent cases discussed earlier. Whether a court would uphold such a request by the state would depend on the severity of the child’s illness and the potential consequences to the child of not receiving the treatment.
“Enhancement” Medical Decisions
In this final category the law generally permits parents latitude to make those medical choices they believe will improve the physical, intellectual, or emotional well-being and prowess of their offspring, even though many—and in some cases most—other members of society would not necessarily sanction their choices. Current controversies over the wisdom of surgically placing cochlear implants in the ears of deaf children (Lane and Grodin, 1997) and the practice of male circumcision (Provenmire, 1998/1999), illustrate this point. Critics argue that parental authorization for such functionally irrevocable medical procedures during childhood, when there is no medical necessity for the intervention, violates the child’s constitutionally protected right to adult bodily integrity. They contend that performing these procedures during childhood precludes the possibility that the child might make a different choice in adulthood about how to experience critically important aspects of life and its attributes. So far those arguments do not seem to have been found convincing by the courts, however.
Some irrevocable parental choices, however, fall outside the range of what is deemed acceptable medical “enhancement” for children in Western—indeed in some cases global—cultures. The practice of female circumcision, or clitorectomy, falls within this category, not only because of its brutality but because it forecloses one source of sexual pleasure for women (Annas, 1996). Female genital mutilation is classified as a federal crime in this country,42 so parents therefore have no authority to consent to it, whatever their reasons or beliefs. 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
elective cosmetic surgery (reshaping a nose, for example) for the child or treating a child with hGH simply to provide a relatively short, though well within normal size, youngster with what the parents consider a more imposing physical presence (Cuttler et al., 1996). Burgeoning research into genetic therapies multiplies exponentially the possibilities for future “medical enhancement” of children, raising for some the specter of “master race” genetic manipulation and a widening gulf between the world’s haves (who could afford it) and its have-nots (who presumably could not).45
Immunotherapy with more or less long-term attributes could be categorized as an enhancing, rather than a merely protective, procedure for a child. Presumably this category would apply when a parent contemplates authorizing immunotherapy that is not otherwise widely available for children or acceptable as a general public health measure. Parental decision making in this circumstance would be subject to the same ethical and legal criticisms as have been leveled against other elective procedures on minors that are not otherwise deemed medically necessary and whose long-term effects could conceivably carry over into adulthood in ways that the child’s adult persona might not choose.
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), has long been a hotbed of political debate (Grodin and Glantz, 1994; Ross et al., 2002). That controversy intensified after 1997 when Congress passed the Better Pharmaceuticals for Children Act.48 Then 4 years later a decision of the Maryland Court of Appeals excoriated the exploitation of minor subjects of clinical research in a decision that sent shock waves through the
On the use of genetic techniques to “enhance” children, see generally Mehlman (1999).
These drugs have not yet received FDA approval for marketing in interstate commerce.
See Nabi Biopharmaceuticals News Release, available at http://www.nabi.com/releases/021903A.html [February 19, 2003]. For an analysis of similar ethical and legal problems raised by behavioral genetics research concerning adolescents and smoking, see Wilford et al. (2002).
The Better Pharmaceuticals for Children Act is a provision of the FDA Modernization Act of 1997 (FDAMA), P. L. No. 105-115, 111 Stat. 2296 (1997).
scientific research community.49 That important opinion found in essence that neither parents, nor scientific researchers, nor the institutional review boards designed to protect the human subjects of medical research can be fully trusted to protect children who are the subjects of nontherapeutic clinical research (Hoffman and Rothenberg, 2002).
The Better Pharmaceuticals for Children Act was enacted in part to remedy the status of children as “therapeutic orphans,” so described because most of the medications doctors prescribe for them have not been adequately studied in pediatric populations (Gregory, 1997; Shirkey, 1968). In 1998 the FDA issued what is popularly known as the Pediatric Rule designed to implement that legislation.50 The Association of American Physicians and Surgeons et al. challenged the regulation as beyond the scope of the FDA’s statutory authority because it would effectively constrict off-label drug prescribing. The District Court for the District of Columbia agreed, finding that Congress “would likely have spoken more clearly” if it intended to grant the FDA authority to require drug manufacturers to study their products for off-label uses, and enjoined its implementation.51 The American Academy of Pediatrics et al. moved for expedited consideration of the appeal as intervenor defendants, stressing the overriding need to protect children, but its motion was denied in December 2002 by the D.C. Circuit.52 Suffice it to say that the controversies surrounding using children as the subjects of clinical research are far from resolved.
Drugs and vaccines in preliminary clinical trial stages cannot be promoted as legitimate therapeutic options for anyone, let alone children (Glantz, 1998). 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). Whereas one might be able to make the case for administering an investigational vaccine to children in the midst of a life-threatening epidemic of, for example, anthrax poisoning or smallpox, one would be hard pressed to come up with a similarly compelling scenario to justify the administration of unproven anti-addiction immunotherapy to minors.
GOVERNMENT IMPLEMENTATION OF ADDICTION PREVENTION PROGRAMS THAT COULD AFFECT MINORS
Public health improvement measures raise legal questions and charges of government paternalism when access and targeting of suspect populations become policy issues. In the case of drug addiction immunotherapies, the legal questions relevant to this appendix involve targeting more than they do access to therapy. If immunotherapies prove to curb rates of addiction significantly, entities such as the Center for Substance Abuse Prevention may be expected to focus on innovative ways to implement them through public health initiatives targeting high-risk individuals, including minors.
The task of defining high-risk populations has the inevitable potential to facilitate invidious discrimination. Some scientific studies indicate that drug abusers may possess a genetic predisposition to addiction, and the National Institute on Drug Abuse (NIDA) has launched an initiative to gather research on genetic factors that might create a susceptibility to drug addiction (Stocker, 1999). Environmental factors such as local rates of drug use and availability of family support can also contribute to the likelihood of addiction. These factors can help authorities identify who needs prevention and treatment most desperately, but this kind of social targeting can also trigger deliberate or inadvertent discrimination. It could precipitate advocating immunotherapy for people who might not have become addicted but who just happened to live in lower-income communities or who possess a genetic predisposition that would never have materialized in addiction.
At least one commentator has postulated that these immunotherapies could be administered to every citizen, regardless of the individual’s personal propensity for addiction (Cohen, 1997). Peter J. Cohen, adjunct professor of law at Georgetown University Law Center, argues that universal vaccination would neatly eliminate the potential for discrimination when determining who should receive immunotherapy. Universal vaccination would also reduce the likelihood of long-term discrimination against those in whom the vaccine can be easily traced. 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
century because the vaccination program had a “real and substantial relation” to “preserv(ing) and protect(ing) 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. Because drug addiction is not an infectious or a contagious disease like smallpox or hepatitis (at least not in the medical sense), the state’s public health interest in preventing further substance abuse addiction is weaker. Mass vaccination against contagious diseases like smallpox is designed to eradicate the disease from the entire community so that compulsory vaccination becomes unnecessary in the future. Since people contract smallpox from others who already have the disease, eliminating it from an entire community eliminates the risk of contagion. Substance abuse, however, often stems from social contagion; it is more likely to “spread” when drug use rates in a community are high. An unvaccinated individual can nonetheless succumb to addiction regardless of addiction rates in the surrounding community.
Prisoners’ basic constitutional rights are restricted by the very nature of the incarceration that deprives them of their liberty. Their right to travel, which the Supreme Court has deemed a fundamental right,55 is limited by their confinement (Mushlin, Kramer, and Gobert, 1993). Some religious practices that might enjoy constitutional protection in other circumstances may be stifled in order to protect the states’ interest in general prison welfare and discipline.56 Freedom of speech can be silenced by prison officials when there is a “clear and present danger that [the words or acts] will bring about substantive evil that Congress has a right to prevent.”57 On the other hand, prisoners have limited rights to receive rehabilitation services and in some cases a right to refuse rehabilitation altogether (Kerper and Kerper, 1974).
Prisoners show a disproportionate rate of drug use,58 which suggests that they could be targeted for drug addiction immunotherapies by enforcement authorities and others. Drug prevention and counseling efforts already focus on the inmate community in the hope that eliminating controlled substance abuse will reduce the likelihood of repeat criminal offenses upon release.59 In particular, juvenile detention treatment programs are designed to attack the problem of drug use and addiction early, so that juvenile offenders do not become career criminals to support their addictions. Whether immunotherapies should be added to the list of prevention and treatment resources for incarcerated prisoners and juveniles is a rich subject for political and legal debate.
One area where prisoners (and others) have clear legal protections is in the field of medical research. The federal Common Rule, which mandates standards for human subject protection in medical research, demands that a prisoner’s decision to participate in clinical research be free from coercion.60 As a vulnerable population, prisoners (especially incarcerated juveniles) can be coerced into “volunteering” for research protocols when probation, parole, or other privileges are offered as inducements or threatened to be withdrawn. The voluntary nature of prisoner participation in clinical trials is thus by definition suspect.
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. The same protective, autonomy-enhancing rationale that inspired these research protections could frame the administration of drug immunotherapies in the prison context. Requiring, or even suggesting, medical treatment as a condition of parole or probation can be characterized as coercive (Cohen, 1997). Under some circumstances such attempts at “persuasion” could conceivably exert pressure so overbearing as to approach the cruel and unusual punishment level forbidden by the Eighth Amendment.
The Supreme Court has invalidated compulsory sterilization for those convicted of felonies involving moral turpitude,61 citing the equal protection clause of the Fourteenth Amendment. As Justice Douglas, writing for the majority in Skinner v. Oklahoma, explained, there is no redemption for the individual whom the law touches. Any [medical] experiment which the State conducts is to his irreparable injury. He is forever deprived of a basic liberty.”62
Controversy has also erupted over incorporating the birth control drug Norplant63 into sentencing and parole incentives64 and over programs that make the contraceptive more easily available to targeted sectors of society such as inner-city teenage girls. Soon after the FDA approved Norplant as a female contraceptive, the Philadelphia Inquirer published a highly controversial editorial suggesting that Norplant could be effective in “reducing the underclass” (Kimelman, 1990). Intense debate ensued, with the public strongly supporting not only making Norplant available to young women without parental consent but also making Norplant mandatory for drug-abusing women of child-bearing age.65 Those who opposed the coercive use of Norplant argued that those in power wanted to use it to prevent poor minority women from “clutter(ing) up the gene pool” (Carrie Buck, 1991). There has not yet been a successful challenge—or seemingly any legal challenge, for that matter—to the constitutionality of Norplant use as a condition of parole (Stadler, 1997). Norplant apparently remains available as a sentencing component, although the political hullabaloo has quieted because of the drug’s relatively infrequent use.
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
repeat child molester’s punishment to include chemical castration,66 a procedure through which offenders must undergo regular injections of Depo-Provera to control antisocial sexual urges. Judges can use chemical castration as a sentencing tool to reduce the likelihood that sex crimes will recur, and defendants can use chemical castration as a plea-bargaining tool to reduce incarceration periods or to speed up probation. With similar political support, a state could theoretically enact legislation that would require or induce criminals convicted of drug-related crimes to receive drug immunotherapy to curb the overall rates of drug addiction and to reduce recidivism (Cohen, 1997).
The ability to procreate arguably warrants a greater level of constitutional protection than does the ability to procure a chemical high from a controlled substance. 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
Schools have obvious reasons for promoting drug-free environments. Drugs and the socially disruptive behaviors they tend to produce can cause virtually insurmountable obstacles to the educational experience. Since adolescents congregate at schools, drug prevention programs targeting kids naturally focus on implementation in schools. These programs have been implemented in many educational institutions to curb rates of drug use,68 but they would undoubtedly have more impact if immunotherapy rendered adolescents incapable of experiencing the high that controlled substances offer.
Perplexing legal questions complicate the administration of drug addiction immunotherapies in schools. First, which students would be offered, exhorted, or even coerced to undergo the treatment? Would school administrators target only those students likely to become addicted?
Cal. Pen. Code § 645 (2003); Stadler (1997).
Arthur (1992), suggesting that “a court order to use Norplant as a condition of probation may violate the doctrine of informed consent.”
For general programs promulgated by NIDA, see “NIDA Goes to School,” available at www.nida.nih.gov/GoestoSchool/NIDAg2s.html [accessed February 22, 2003], detailing NIDA’s current school-based drug prevention programs.
If so, how would they decide whom the population should include? Or would only those schools truly desperate to curb existing rates of drug use (perhaps schools for troubled adolescents or inner-city schools in high-crime neighborhoods) embrace immunotherapies? The potential answers to these questions suggest that discrimination and prejudice will surface if students’ perceived likelihood of addiction becomes a determining factor in whether their school offers or mandates treatment for particular individuals or indeed to entire school populations.
Similar ethical and legal problems are raised when schools attempt to require children with attention-deficit hyperactivity disorder (ADHD) to take Ritalin, and the legal opinions on this subject may be instructive. As could be the case with immunotherapy, some teachers have sought to make taking Ritalin a precondition for staying in school, regardless of parental or the child’s consent. While the law in this area is murky, many courts have found that educators cannot force children to take Ritalin without parental consent, although they have also confirmed that parents can legally administer it to children without the minor’s assent (Komoroski, 2001). The take-home lesson is that parental rights with respect to medical decision making for their offspring usually trump those of educators.
The Supreme Court has recently upheld a school district’s drug-testing program, required for participation in interscholastic activities, however.69 The testing program survived a Fourth Amendment challenge because the defendant demonstrated “special needs” by showing the students’ extraordinarily high rates of drug use. This defense to Fourth Amendment disputes applies when “special needs exist beyond the normal need for law enforcement, making the warrant and probable cause [Constitutional] requirement impracticable.”70 Drug testing as a component of a drug abuse prevention/intervention program is therefore constitutional if special needs are found to justify it. Although similarly coercive immunotherapy “requirements” would be considered more intrusive under the Fourth Amendment than mere drug testing and thus would less likely be deemed constitutional, the special needs analogy is instructive notwithstanding the outcome of the Ritalin cases.
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.
Addiction immunotherapies present intriguing potential for improving public health and personal well-being, but the question of whether, or how soon, they should be, or could be, administered to minors, particularly nonconsenting adolescents, is not a simple one. This appendix has attempted to flesh out the time-tested lawyer’s answer (to queries highly dependent on factual context) of “that depends” with a structured legal and ethical analysis based on analogies to existing common and statutory law. By focusing on the particular kind of immunotherapy proposed to be administered to the child, the imminence of the threatened harm, the persistence of its effects, and by isolating the reason proffered for administering it—whether it be for the child’s protection, treatment, or “improvement”—it is hoped that this appendix has contributed to this important dialogue.
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