The Use of Immunotherapies and Sustained-Release Formulations in the Treatment of Drug Addiction: Will Current Law Support Coercion?
M. Susan Ridgely, Martin Y. Iguchi, and James R. Chiesa
RAND Corporation, Santa Monica, California
Immunotherapies and sustained-release medications may be the hope of the future for many individuals addicted to drugs who are willing, even eager, to access state-of-the-art treatment. They may also seem attractive to a society seeking to lower the high social and economic costs of addiction among such populations as recidivist drug offenders, homeless individuals addicted to drugs, and drug-abusing pregnant women and mothers. Experience suggests, however, that in these populations and others, some individuals will refuse treatment or participate for only a time and then drop out. They may participate or adhere to treatment regimens only if they are mandated to do so.
For that reason this appendix addresses the following question: Will current law support the coercive use of immunotherapies against drugs of addiction? The discussion, in outline, runs as follows. Authority to coerce treatment is derived from the government’s responsibility to provide for public health and comfort but is substantially constrained by the countervailing rights of individuals for self-determination in medical treatment. Those rights typically assume the competence of the individuals making the self-determination. Certain classes of individuals may be regarded as lacking that competence; however, a clear legal foundation for broad attribution of incompetence to persons with drug dependence is not found. Even given competence, though, the interests of the state may prevail over those of the individual within certain classes of people, particularly among those who may have effectively waived their right of refusal. In such cases, coercion might be legally sustainable, and this appendix discusses potentially pertinent statutes and case law bear-
ing on the ability of the state to justify the use of coercion. It is concluded that for some classes of individuals and in some situations, coerced immunotherapy is likely to be legal, subject to the constraints of due process and establishment of the modality’s safety and effectiveness. Assuming a situation in which immunotherapy may be legally coerced, the appendix concludes with some reflections on fairness in implementing coercion policy.
The entire discussion here is necessarily subject to substantial uncertainty. Given the novelty of immunotherapies, no law has been developed pertaining to them, so likely legal authority must be inferred from a set of successively more generalized or analogous areas of law: first, from the very sparse law pertaining to coercion of other modalities of substance abuse treatment; second, from the law pertaining to coercion of substance abuse treatment in general, also sparse; and third, from the law pertaining to coercion of treatment for mental illness, which is more developed but only analogous. While this approach cannot lead to very confident predictions, it may well mirror the thinking of courts as they review precedents to inform their future decisions regarding coercion of immunotherapy.
THE GOVERNMENT’S RIGHT TO COMPEL TREATMENT FOR DRUG ADDICTION
The law permits the government to enforce addiction treatment under parens patriae and police powers. Although the U.S. Constitution generally confers broad autonomy to individuals, parens patriae and police powers are invoked by the government to limit the actions of individuals when broader societal interests are at stake.
Parens patriae, translated literally from the Latin, means “parent of the country.” This power lies with the states, where it has been broadly interpreted as the right to protect interests such as the health and welfare of the people. For example, all states permit the civil commitment of individuals with mental disorders. The rationale for civil commitment is to provide treatment for mentally disordered individuals as well as to prevent harm to the larger society.
Overlapping parens patriae are police powers. These are derived from the Tenth Amendment to the U.S. Constitution, which reserves to the states any powers not explicitly delegated to the federal government. Under their police powers, states (and by delegation localities) may “adopt such laws and regulations as tend to prevent the commission of fraud and crime, and secure generally the comfort, safety, morals, health and prosperity of its citizens by preserving the public order, preventing a conflict of rights in the common intercourse of citizens, and insuring to
each an uninterrupted enjoyment of all the privileges conferred upon him or her by the general laws” (Black’s Law Dictionary, 5th ed.).
While states possess significant power under these principles, the Fifth Amendment of the U.S. Constitution also provides that no person shall be “deprived of life, liberty or property without due process of law.” It is this due process clause that has provided a balance of protection for individuals in situations where the power of the state and the autonomy of individuals come into conflict.
THE RIGHT OF INDIVIDUALS TO DETERMINE THEIR OWN MEDICAL TREATMENT
Generally, competent adults have the right to make their own decisions about whether to accept or reject medical treatment, free from interference by anyone, including the government. These rights are found in the common law and the U.S. Constitution and are maintained through the doctrine of informed consent.
Informed Consent and Refusal
The doctrine of informed consent generally provides that physicians may not perform any medical procedure on a competent adult patient in a nonemergency situation without explaining the risks and benefits of the procedure and obtaining the patient’s voluntary consent. This informed consent doctrine is founded in tort law and state statutes. (For a review of statutes, see Andrews, 1984.) As established in the former, consent must be knowing, voluntary, and competent.1
In Cruzan v. Missouri Director of Health, the U.S. Supreme Court held that the right to refuse treatment is a part of the constitutional right of privacy.2 Justice Rehnquist, writing for the majority, stated: “The logical corollary of the doctrine of informed consent is that the patient generally possesses the right not to consent, that is, to refuse treatment.”3 In other words, if individuals are competent to consent to treatment, they might choose to refuse it instead. If they are not competent to consent/refuse treatment, the government might be in a better position to coerce. If informed consent applies only to competent adults, what about individuals addicted to drugs and children?
Consent by Persons with a Substance Use Disorder
Addiction may be a factor limiting competence. It is widely acknowledged that consent should not be pursued while a person is acutely intoxicated. However, what if a person is addicted but not acutely intoxicated when a decision about treatment is to be made? Does addiction make someone per se incompetent to provide informed consent for treatment?
At least one court has weighed in on the issue of per se incompetence. The California Supreme Court in its opinion in In re: Jones stated that addiction does not render an individual per se incompetent to voluntarily submit to addiction treatment.4 Support for this notion is found in the case law on mental illness, where the courts have ruled that people with mental disorders enjoy a presumption of competence absent an adjudication of incompetence,5 even though it is widely recognized that mental disorders may affect cognition and judgment.6
However, states have an obligation to assure that voluntary consent is truly voluntary. In Zinermon v. Burch, staff at a state mental hospital allowed a mentally ill individual to sign voluntary admission papers while psychotic, disoriented, and heavily medicated.7 The implication of the U.S. Supreme Court ruling in Zinermon is that states are obliged to pursue civil commitment, with its due process protections for the individual, where there is a question of competence to voluntarily consent to treatment.
Even in the case of adjudicated incompetence, the state does not necessarily have the right to make a decision about treatment for the individual if there are others available to act on his or her behalf. The courts have recognized the right of incompetent individuals to bodily integrity and to consent or refuse treatment through guardians or other representatives.8
Consent by Children or Adolescents
How is the issue of competence handled in the case of children? Those under the age of majority are legally incompetent to make medical decisions for themselves. Generally, parents are the substitute decision makers for their children.
Adolescents—usually defined as children between the ages of 14 and 18—are regarded as minors by the courts. However, state statutes allow adolescent decision making without parental review in particular areas of health care, including substance abuse treatment. As of 2002, statutes of this type had been passed in 29 states (Hartman, 2002).
These laws, however, address access to desired care, not consent to potentially undesired care—or, by implication, its refusal. Hartman emphasizes that the “refusal of unwanted medical treatment is noticeably absent from the statutory provisions that afford legal autonomy to adolescents for medical decision-making” (p. 418). Case law in this area is sparse and not directly relevant to this appendix’s purposes.9 Thus, there is little guidance on how the courts would handle the situation of a parent attempting to enforce the use of immunotherapy on an unwilling adolescent.
GOVERNMENT PREEMPTION OF THE INDIVIDUAL’S RIGHT TO REFUSE TREATMENT
The U.S. Supreme Court in Cruzan v. Missouri Director of Health specifically acknowledged that the right to refuse treatment was not absolute:
But determining that a person has a liberty interest under the Due Process Clause does not end the inquiry; whether respondent’s constitutional rights have been violated must be determined by balancing his liberty interests against the relevant state interests. (emphasis added)10
Something can be learned about how courts might balance these interests in the case of immunotherapies by examining the involuntary administration of psychotropic medications to persons with mental illness. The courts have enunciated a qualified right of mentally ill individuals to refuse psychotropic medications, finding that there are circumstances in which the government’s interest in compelling treatment outweighs the individual’s right to refuse treatment. For example, in Riggins v. Nevada the U.S. Supreme Court allowed the administration of psychotropic medication over the refusal of a criminal defendant when the purpose of treatment was to restore competence to stand trial. However, the court found that due process would be violated without there being a finding that the medication was justified by safety considerations and that there were no less intrusive means to accomplish the same result.11
The court recently clarified the standard for permitting forced medication in Sell v. United States.12 Justice Breyer, writing for the majority,
stated that the government interests at stake must be important, forced medication must significantly further those state interests, there must be no less intrusive treatments likely to achieve substantially the same result, and the treatment must be medically appropriate.13 Judicial review is not necessarily required to override refusals. State courts have found that administrative boards within institutions to which mentally ill persons were civilly committed were sufficient to protect the qualified right of patients to refuse medication.14
Interestingly, as Mossman (2002) points out in his recent review of this area of the law, side effects have figured prominently in the analysis by the courts. In Rennie v. Klein the court emphasized that doctors must consider whether and to what extent the patient will suffer harmful side effects. Mossman reports that decisions by state courts since Rennie have continued to focus on the medical appropriateness of the medication and whether there are less intrusive alternatives.
Under what other circumstances or for what classes of people can the government override the individual’s right to refuse treatment? Legislatures and courts have approved the exercise of government power to mandate treatment for various classes of addicted individuals, who might broadly be divided into those who have committed crimes and those who have not. The limits of government power, and the protections afforded persons who abuse or are dependent on drugs by statute or by the U.S. Constitution, are briefly described below.
Some states (e.g., California) mandate treatment for prison inmates with some history of substance abuse.15 While there is no case law on inmate refusal of substance abuse treatment, in Washington v. Harper the U.S. Supreme Court addressed the issue of involuntary psychotropic medication for inmates with mental illness.16 Of the decision in Harper, Siegel, Grudzinskas, and Pinals (2001) wrote:
[T]he court recognized the core substantive due process right implicated by involuntary psychotropic medication—even for a defendant who had already been convicted and who unquestionably presented some threat. It concluded, however, as a matter of substantive due process, that the
imposition on liberty was justified based on the needs of correctional management, and that the process used to determine the need for medication was adequate, given the limited procedural rights accorded convicted criminals. (p. 307)
Therefore, it seems reasonable to conclude that inmates would have a right to refuse medication unless their mental illness made them a threat to themselves or others. Would immunotherapies meet the definition of justified involuntary treatment under Harper? It is not clear that they would, since control of violent behavior is not a byproduct of immunotherapy. That would be especially true if there were other addiction treatments that the inmate was not refusing.
As for due process protections, these legal scholars strongly urge that the decision to override refusal of medication be made by a court or an independent administrative body within the institution. They also recommend that the state be obligated “to establish the need for the medication and medical appropriateness of the drug” by clear and convincing evidence.17
Parolees and Probationers
Many persons who abuse or are dependent on drugs in the criminal justice system are on parole or probation. Parole is the release of incarcerated individuals after they have served some portion of their sentence. Probation permits a person convicted of a crime to go free with a suspended sentence. Conditions are attached to each, and violation of those conditions can result in incarceration (Petersilia, 1998). One such condition might be participation in an addiction treatment program.18
Probation and parole are both privileges, not rights.19 Release under parole or probation is made with conditions, which may include random drug testing and addiction treatment, and therefore persons with substance use disorders can be said to have, in a sense, “volunteered” for treatment. Failure to follow through with treatment or failure to pass drug tests may be grounds for revocation of parole or probation.
Can parolees or probationers deliberately refuse treatment? This issue does not seem to have been addressed, perhaps because opportunities for probationers or parolees to receive any kind of community-based substance abuse treatment are reported to be few (Petersilia, 1999). However, while parolees and probationers may be free to reject specific modalities
of treatment, the administrative agencies and the courts may respond by revoking probation or parole for noncompliance with the conditions on which the release was made.
Arrestees and Convicted Persons Diverted to Treatment
In a number of states prosecutors are empowered to withdraw criminal charges or hold them in abeyance so that arrestees can enter drug treatment rather than being incarcerated. In addition, states may allow judges to order drug treatment for those already convicted of a crime but not yet sentenced.20
One well-publicized method of diversion is the drug court. Drug courts have been defined as “separately identified criminal court dockets that provide judicially supervised treatment and case management services for drug offenders in lieu of criminal prosecution or incarceration.”21 Drug courts vary across jurisdictions, but they tend to include ongoing judicial supervision, random urinalysis testing, mandatory participation in addiction treatment, and the imposition of graduated sanctions for noncompliance with any established condition.
The legal “hold” that drug courts have on their clients is that they typically enter a guilty plea to criminal charges or are required to stipulate to the facts in the arrest report as a condition of being accepted. Once that is done, termination from the program (for noncompliance) would result in conviction and sentencing.22 Because clients agree to the program’s conditions in advance, they can be said to have “volunteered” for treatment. Generally, it is left to addiction professionals, in consultation with the presiding judge, to determine the course of treatment.
In at least two states (California and Arizona), voters have passed diversion laws that do not rely on drug courts.23 In California, under Proposition 36, any nonviolent offender charged with simple drug possession or use is diverted from criminal prosecution and placed on probation, conditional on addiction treatment (Cal. Penal Code § 1210.1)
(Deering, 2003). Offenders who complete drug treatment are entitled to have their arrest and conviction expunged.
For purposes of treatment compliance, participation in such programs, like participation in drug courts, is “voluntary” on the part of offenders. Decisions about what kind of treatment to mandate are made by treatment providers, according to their professional judgment. There is nothing in the law to suggest that participants who have agreed to the conditions of the diversion program can then refuse to participate in the specific treatment offered, including any prescribed medication. However, California law does provide for a full panoply of due process protections.
More than any other class of noncriminal persons with a substance use disorder, homeless individuals are likely to draw attention regarding treatment coercion. Various strategies have been used to encourage homeless individuals with behavioral health problems to enter treatment. The strategies have included efforts to bring people into treatment by first addressing needs for food and shelter, as well as more coercive measures such as threats of criminal charges for loitering, public intoxication, and so forth, unless treatment is undertaken. Some newer statutes have allowed for outpatient commitment (or “assisted outpatient treatment”), though typically to address mental illness, not addiction (Ridgely, Borum, and Petrila, 2001). It is noteworthy for our purposes, however, that some of those statutes (e.g., those in Michigan and New York) do not empower authorities to medicate individuals against their will. Special court orders are necessary. In New York the government can obtain such an order only upon finding that a patient lacks the capacity to make treatment decisions.24
Parents with a Substance Use Disorder and Child Protective Services
Congress, state legislatures, and the courts have from time to time attempted to create drug-related incentives or disincentives within the fabric of social welfare programs not directly related to addiction. In 1996, Congress passed the Personal Responsibility and Work Opportunity Reconciliation Act, which contained provisions affecting people with addictions. For example, it authorized states to develop programs to condition the payment of welfare benefits on drug testing (21 U.S.C. § 862b (2003)).
Michigan enacted a statute authorizing a pilot program to test welfare beneficiaries for drugs in three counties (Mich. Comp. Laws. § 400.57 et.
seq. (2003)). The statute also required that individuals who tested positive complete substance abuse treatment. The Michigan law went into effect in 1999 but was almost immediately blocked by a federal judge.25 U.S. District Judge Victoria Roberts ruled that the plaintiffs were likely to succeed on the merits of their claim that such indiscriminate drug testing was an unconstitutional search, and this decision was allowed to stand by the federal appeals court.26 Since Michigan was the only state to attempt to institute drug testing in response to the congressional invitation via federal welfare reform, the federal court’s action will likely put a chill on any further such legislation at the state level.
In her decision, Judge Roberts emphasized that the state of Michigan had other means to address the effects of addiction on child abuse and neglect (e.g., child protective services). Under statutes in Michigan and other states, child protective services agencies may remove neglected children from their homes, terminate parental rights, and put the children up for adoption. Addiction can provide the basis for a finding of neglect. Such agencies may also require parents with a substance use disorder to undergo evaluation and treatment for addiction (Paltrow, Cohen, and Carey, 2000).
Courts in various states have upheld the right of child protective services agencies to implement sanctions for the failure of parents with a substance use disorder to comply with treatment recommendations. For example, the Supreme Court of Montana in In re: J.B. upheld the termination of a mother’s parental rights on her failure to complete a treatment plan.27 The Ohio courts have also upheld terminations for noncompliance with reunification plans that included addiction treatment.28 Oregon courts have ruled that the right to due process in these types of proceedings is not violated as long as the proceedings are fundamentally fair.29 But courts in at least two states have ruled on the termination of parental rights based on proof by clear and convincing evidence that the parent has not complied with the treatment conditions of the plan.30
What seems clear is that child protective services agencies can mandate that parents seek evaluation for addiction and follow through with treatment. Whether agreement to these terms can be considered voluntary given the sanctions involved is arguable. No case law was found to suggest that there are limits to specific modalities of treatment that can be mandated under these statutes. However, it is safe to assume that experimental treatment would probably fall outside the bounds of what the courts would deem reasonable.
Pregnant Women with a Substance Use Disorder
Much publicity in the past several years has surrounded the use of criminal and child abuse laws to address the problem of prenatal addiction. According to the Alan Guttmacher Institute, as of January 2003 no state had enacted a statute specifically criminalizing drug use during pregnancy. However, prosecutors and other public officials have used existing laws for several purposes: to criminally prosecute pregnant women, to evaluate parenting ability or terminate parental rights (Paltrow et al., 2000), to require reporting or testing by health care professionals, and to civilly commit women with a substance use disorder during the term of their pregnancy (Alan Guttmacher Institute, 2003).
The U.S. Supreme Court has spoken on one such policy, striking down a prosecution-focused collaboration among police, prosecutors, and a university hospital in South Carolina. The case before the court was brought by 10 women who were tested for drugs without a warrant or their consent while receiving prenatal care at the hospital, which turned over the results of positive drug tests to local prosecutors. In Ferguson v. City of Charleston, the U.S. Supreme Court found that these practices violated the Fourth Amendment right to be free from unreasonable searches.
Interestingly, the South Carolina Supreme Court continues to be the only one to have upheld lower court rulings on arrest and prosecution of pregnant women for drug use.31 Given that state attempts to prosecute pregnant women have been curbed by the courts, some have suggested mandated treatment as a “compromise” that can less punitively accomplish public health goals. What would be the legal means of mandating treatment? Most states have civil commitment statutes that can be used for such a purpose, but whether a fetus can be defined as an “other” (to meet the commitment criteria of “danger to self or others”) is not clear (Chavkin, 1991). Treatment also can be used as an alternative to trial or incarceration or as a precondition for retaining custody of children.
Given, however, that the overall goal of intervening in the lives of pregnant women with a substance use disorder is to safeguard their fetuses from exposure to drugs, what implications are raised by the use of pharmacological addiction treatments? It is very unlikely that pregnant women will have participated in premarketing clinical trials for immunotherapies. There will, therefore, be no safety data on the potential toxicity to pregnant women and their fetuses, which would undermine justification for enforcing the use of immunotherapies by pregnant women (Chavkin, 1991).
SUMMARY OF LEGAL BASIS FOR COERCING IMMUNOTHERAPY
In a nutshell, and subject to the uncertainties discussed at the outset, this appendix’s findings may be stated as follows:
People with a substance use disorder are not per se incompetent simply by virtue of their addiction, although a substance use disorder may compromise their ability to give informed consent to treatment.
The law regarding adolescents is insufficiently developed to allow prediction of what the courts might decide as to their ability to refuse immunotherapy if their parents consent to it.
The interests of the state may override individual rights and permit coercion of treatment generally in the case of violent prison inmates but not immunotherapy in particular.
Persons who accept parole, probation, or diversion to treatment have effectively “volunteered” for treatment and probably can refuse immunotherapy only if they are willing to risk the consequences of such refusal (i.e., probable incarceration).
Most likely, immunotherapy cannot be forced on competent adults who abuse or are dependent on drugs but have not been convicted of a crime (e.g., homeless people, parents under the purview of child protective services, pregnant women). However, parenting women may risk consequences related to nonadherence to treatment generally.
ISSUES OF FAIRNESS IN COERCING THE USE OF IMMUNOTHERAPIES AND SUSTAINED-RELEASE MEDICATIONS
Should legislatures and the courts decide that coercion of immunotherapies is permissible, either narrowly or broadly, that does not neces-
sarily imply that it is appropriate in all situations allowed. Two aspects of fairness in implementing a coercion policy are addressed here: issues of safety and effectiveness and issues of coercion within relationships of trust.
Safety and Effectiveness
Many of the legal rulings to date have invoked the caveat that pharmacological addiction treatments must be deemed safe and effective. For whom will these treatments be so? Premarketing clinical trials are often not able to represent every ethnic, racial, and age group and typically do not include children, adolescents, or pregnant women. The groups most likely to be considered for mandatory treatment are individuals involved in the criminal justice system (disproportionately represented by ethnic and racial minorities), adolescents, and pregnant women. This mismatch argues for caution in the coercive use of these therapies until adequate safety data can be gathered across the broad spectrum of potential users.
Effectiveness also includes issues of adherence to protocols. If immunotherapy results in insufficient antibody production to completely “capture” the drug circulating in the body, some drug users might seek to overcome the blockade by using a larger drug quantity. That may result in side effects that clinical trials did not uncover. Also, because drug-dependent individuals will not be able to easily ascertain their circulating antibody levels, their supernormal doses may be taken to challenge an antibody effect that is no longer there, potentially leading to accidental overdose.
Coercion and Trust
Coercion, especially in noncriminal justice settings, has great potential for harming the relationship between the parties involved. Deterioration of a parent-child relationship could lead to greater risk taking, rather than less. In the case of pregnant women, coercive use of immunotherapy could result in fewer persons with a substance use disorder presenting for prenatal care in order to avoid being subjected to unwanted testing and treatment.
The literature on mandated treatment in the mental health arena suggests that there are situations where coercion may be arguably necessary (and certainly legal), but good clinical practice should attempt to minimize its negative effects. Regarding persons with mental disorders who were involuntarily treated, the recent MacArthur coercion studies (Lidz et al., 1995) concluded:
Patients in the admissions process who reported that others acted out of concern for them, treated them fairly, in good faith, with respect, and without deception, provided them with an opportunity for voice, and took what they said seriously were much less likely to experience coercion. When these moral norms reflecting patient attitudes about how they should be treated are adhered to, many apparently coercive acts seem to be accepted by the patient as morally legitimate. (Winick, 1997, p. 1159)
While the MacArthur studies did not demonstrate that perceptions of coercion were related to treatment adherence (Rain et al., 2003), care should still be taken to assure fairness and respect in determining who should be required to accept immunotherapy treatments and in administering such treatments.
This appendix does not attempt a broad argument against immunotherapies. These new therapies might have tremendous benefits for society—if they prove safe and effective for all groups of potential recipients and if trust-building measures are taken where coercion is necessary. The importance of those conditions is simply emphasized.
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Siegel, D.M., Grudzinskas, A.J., Jr., and Pinals, D.A. (2001). Old law meets new medicine: Revisiting existing involuntary psychotropic medication of the criminal defendant. Wisconsin Law Review, 307, 313.
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