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New, Experimental, and Life-Saving Therapies

Abstract and Keywords

This chapter focuses on the issues raised by experimental and innovative life-saving therapies, including equity and distributive justice, patient autonomy, and the role of various government institutions in regulating access to such therapies. It first considers the definitional vagueness of key terms pertaining to experimental and life-saving therapies, together with their often politicized nature. These include the terms “experimental” and “medical necessity.” It then charts the history of the regulatory regime for medical therapies before discussing three principal frameworks deployed within legal discourse to address the problems posed by new, experimental, and life-saving therapies: the constitutional framework (specifically, the constitutional right to access experimental or life-saving treatments), the public health framework, and the ethics and human rights framework. It concludes with the observation that the ethics and human rights framework is the most promising for resolving these challenges but is also the most politically infeasible, given the current state of constitutional doctrine and politics in the United States.

Keywords: life-saving therapies, equality, distributive justice, patient autonomy, medical therapies, constitutional right, public health, ethics, human rights

The breakneck pace of pharmaceutical and technological innovation has increasingly led to the development of experimental or life-saving therapies to which individuals may not always have access at will, whether because of their expense, government regulation, or manufacturers’ decisions to withhold them from the market. For example, some newer cancer drugs may increase life span by only a few months on average, but at an enormous cost. Payers, whether public or private, must make decisions about coverage of such drugs that will, in most cases, translate into a decision about whether the individual patient has access to the therapy at all. On the other hand, patients sometimes seek access to drugs that, although inexpensive, are off-limits because they have not been approved as safe and effective by the U.S. Food and Drug Administration (FDA). Occasional outbreaks of lethal diseases such as Ebola, with their concomitant threat of a global epidemic, place pressure on national governments and the medical community to act quickly by bringing even relatively untested therapies to suffering populations, while sharpening concerns about access and research ethics.1 Finally, some treatments—such as stem-cell derived therapies or sex reassignment surgery for minors—may raise ethical concerns in their own right, even bracketing the problem of who should have access and under what conditions.

The existence of such cutting-edge therapies provoke numerous questions—in particular, how to engineer fair distribution; how best to ensure individual decision-making autonomy in light of imperfect knowledge and information asymmetries; and how to evaluate the institutional competency and proper role of the government vis-à-vis the market in regulating access to these new therapies. There are three principal frameworks deployed within legal discourse in attempting to address these challenges: the constitutional framework, the public health framework, and the ethics and human rights framework. Each framework grapples with all of the problems described in Part III, though each emphasizes some over others, with greater or lesser degrees of success in resolving them. No one approach dominates U.S. health policy; consequently, fundamental conflicts persist over the existence and meaning of a right (p. 292) to healthcare, as well as over the proper allocation of scarce healthcare resources, in both judicial and political fora. Moreover, although the ethics and human rights frameworks hold the most promise for solving the three types of challenges raised by new, innovative, and life-saving therapies, it is also the least likely to predominate in U.S. law and policy.

I Some Definitions

An initial challenge for conceiving a regulatory framework for experimental therapies is defining the term “experimental,” as well as specifying when experimental therapies can be considered medically necessary. “Experimental,” “medically necessary,” and similar terms do not correspond to fixed legal categories. Rather, they are often left vague and undefined, and they are mobilized in different ways, for different purposes, in a variety of contexts. These definitional challenges reflect, to some extent, the decentralized nature of medical decision-making in the United States as a whole: decisions regarding the necessity and propriety of various treatments have historically been made primarily by individual payers or physicians, rather than by governmental entities.2

Of course, the charge of vagueness could likely be made about numerous legally important terms, but that does not necessarily obviate their usefulness. Nonetheless, the definitional vagueness of key terms pertaining to experimental and life-saving therapies, together with their often politicized nature, aggravates some of the difficulties in meeting the challenges posed by new medical technologies. In particular, the lack of a clear understanding of what constitutes medical necessity, on either an individual scale or a broader population level, inhibits decision-making regarding insurance coverage and fair distribution of healthcare resources.

a. “Experimental”

To begin with, the term “experimental” often carries meanings in legal and popular discourse that do not correspond to most medical understandings of the term. In medical usage, “experimental” usually means not only that the particular therapy’s safety or efficacy has not been thoroughly tested or that its acceptance in the medical community is not widespread but also that it is being used with an intent to develop knowledge about the therapy’s safety or efficacy—in other words, that it is being administered as part of a more or less controlled experiment.3 Thus, courts and even insurers sometimes use the term “experimental” when they actually mean something more like “innovative,” because they are referring primarily to the therapy’s new and untested nature.4 Moreover, the Medicaid program, which is (p. 293) the largest insurer in the country, does not define “experimental,” although it permits states to exclude experimental treatments from their programs; Medicaid also does not define “medical necessity,” although the term is central to determining which procedures may be reimbursed under the program’s rules.5

Nonetheless, regulators, insurers, and courts are often called upon in borderline cases to determine whether a treatment qualifies as “experimental,” usually in order to determine whether it falls under an insurance exclusion for such treatments. In reviewing determinations that a treatment is experimental and therefore excluded from coverage, courts often consider factors such as the newness of the therapy, the degree of acceptance in the medical community, and FDA approval or other authoritative evidence of safety and efficacy.6

b. “Medical Necessity”

“Medical necessity” likewise has no authoritative clinical or legal definition.7 Although “medically necessary” is sometimes contrasted with “experimental”—insofar as a particular therapy may be categorized as either experimental (and therefore excluded from coverage) or medically necessary (and therefore covered)—the terms are not exactly opposites. In the coverage context, medical necessity generally refers to a determination that a particular treatment will have therapeutic effect by alleviating pain or illness or restoring normal functioning.8 This determination, by definition, precludes treatments that are experimental—in the sense of new and untested—from its scope, but it does not necessary include all established therapies. Though the concept of medical necessity comprises an element of therapeutic effect, it would not be accurate to assert that every treatment that is likely to bring any therapeutic benefit to a patient, no matter how small, is medically necessary. Such an understanding of medical necessity is far too broad in that it would sweep in expensive treatments that are only minimally therapeutic. The concept of medical necessity thus appears to include some degree of cost-benefit balancing as well.9

(p. 294) The necessity of determining therapeutic impact and of weighing it against the procedure’s cost raises the question of who, precisely, will conduct this balancing. In many cases, the individual treating physician will receive substantial deference, both from courts and insurers, although obviously disagreements may and do arise. In some contexts, government agencies have created lists of covered health services, which has the advantage of eliminating the need to define medical necessity on a case-by-case basis in many instances. For example, Medicaid publishes a list of services that must be covered by state Medicaid programs. Similarly, the Affordable Care Act requires most plans to cover certain categories of “Essential Health Benefits,” such as “emergency services,” “maternity and newborn care,” “mental health and substance use disorder services,” “rehabilitative and habilitative services and devices,” and “preventive and wellness services and chronic disease management.”10 The precise services that fall into those categories are left to the individual states to determine, however. Finally, in the 1990s, the state of Oregon established a relatively comprehensive prioritized list of hundreds of diagnoses and treatments and ranked them in order of importance. It then drew a line above which the Oregon Medicaid program would cover services and below which it would not; the line would—in theory at least—move up or down based on the financial resources available to the program.11

Whether defined on an ad hoc basis or with reference to a predetermined list, medical necessity is a concept that is intensely fraught with profound political and moral implications. One set of problems arises from the implicit or explicit element of cost-benefit balancing that occurs when a particular therapy is determined to be, or not to be, medically necessary. This determination raises profound ethical questions about the value of individual lives, quality of life, and the just allocation of scarce but vital resources. Those difficulties may be magnified by concerns about the reliability and legitimacy of the decision-makers and decision-making methods.

A second set of problems centers around the value judgments that are required in order to determine that a treatment is medically necessary because it is essential for “normal” human functioning, or even normal appearance. For example, when the Obama administration decided to designate contraceptives as preventive care, to be included within the essential health benefits covered by all employers, a political firestorm ensued. Indeed, the place of reproductive healthcare within healthcare more generally has long been contested. Similar problems lurk in deciding when a procedure to restore or even initiate “normal” functioning is medically necessary. For example, some controversy attends the use of cochlear implants, which enable congenitally deaf children to hear, but which are viewed as a threat by the deaf community. The designation of obesity as a treatable medical condition rather as than as the result of poor lifestyle choices similarly raises baseline questions about what the range of “normal” is and about the role of free will in human behavior. The dividing line between the (p. 295) cosmetic and the therapeutic is also often blurred; for example, short stature may be treated by payors either as a medical condition or as a normal variation in physical appearance. Finally, open questions remain about whether emotional and even social considerations should come into play in defining a normal state of “health.”12

c. Individual and Collective Terms

A final tension lurks in the definition of both “experimental” and “medically necessary”: namely, that these terms can be understood at either the individual or the collective level. The quality of a decision-maker’s ultimate determination whether a treatment is experimental or medically necessary is naturally limited by the state of medical knowledge and the existence of research at the time of decision, as well as by the often ad hoc balancing that must occur in individual cases. Thus, for example, while medical necessity often pertains to individual patients and their unique medical circumstances, the term is also used on the programmatic level to designate services that are reimbursable. Alternately, therapies may be experimental in all cases, because new and untested, or they may be well-tested but used for new types of indications or patients, and therefore not reimbursable.

Because of the individualized nature of judicial decision-making, the tension between the individual and the collective becomes particularly acute when courts are tasked with making medical necessity determinations. Courts tend to focus on the individual patient before them in discerning whether a particular therapy is experimental, weighing the costs of the therapy against the benefits to that one person.13 Indeed, in countries that recognize a constitutional right to health, this problem can have significant economic implications. In countries such as Brazil and Colombia, for example, courts have been flooded with individual claims for access to particular therapies, resulting in serious financial impacts for those healthcare systems.14 Multiple individual courts were tasked with deciding individuals’ particular needs, without national-level coordination or the ability to conduct a cost-benefit analysis on a systemic scale. In South Africa, by contrast, the courts have recognized a right to health but have created a wide realm of discretion for government regulators in determining which therapies are required, so as to avoid the problem of the judicial branch allocating scarce medical resources in a way that undermines broader policy objectives adopted by the political branches.

(p. 296) II History

Protection of public health and safety has long been considered the core function of the state; indeed, it is arguably the raison d’être of the state itself.15 But because the professionalization of medicine is a relatively recent phenomenon, and because the line between dangerous quackery and legitimate, proven treatment was, for a long time, relatively blurry, governments in the United States did not take an active role in regulating medical therapies until the early twentieth century.16 The Pure Food and Drug Act, predecessor to the federal Food, Drug, and Cosmetic Act (FDCA), was passed in 1906. The act provided the Bureau of Chemistry in the Department of Agriculture—later named the Food and Drug Administration (FDA)—with enforcement powers over adulterated and misbranded drugs that moved in interstate commerce. While fairly limited in scope at the outset, the FDA’s powers increased with the passage of the FD&C Act in 1938, which was at least partly a response to the widespread problem of false therapeutic claims, which were not regulated by the earlier statute, resulting in serious harm to individuals who ingested unregulated medications. The focus of the new statute was on requiring premarket approval of drugs, along with proper labeling.

Though the FD&C Act has largely retained the same form since 1938, the history of regulation of new and experimental therapies had, in some respects, only begun in that year. After World War II, the world learned of the horrific involuntary experiments conducted on prisoners by Nazi doctors, which led to the promulgation of the Nuremberg Code. The code is a set of ten principles for the ethical conduct of medical research that was initially formulated as part of the American judges’ verdict in trial of the Nazi doctors for war crimes. Though never acknowledged as binding law, the Nuremberg Code’s influence—particularly its emphasis on informed consent as the centerpiece of ethical research—has extended into U.S. law and research regulations, as well as other international documents. For example, it is the basis for the Helsinki Declaration, which also grew out of World War II but was not officially adopted by the World Medical Association until 1964. Drawing in part on the Helsinki Declaration, but also in response to pressing need and ethical concerns raised by the HIV/AIDS crisis of the 1980s and 1990s, the Council for International Organizations of Medical Sciences (CIOMS), an affiliate of the World Health Organization (WHO), issued the International Ethical Guidelines for Biomedical Research Involving Human Subjects.

The history of the regulation of new and experimental therapies is thus, to a great extent, a history of responding to medical, political, and moral crises. These crises have called on physicians to consider the responsibilities created by their twin roles as healers, who must focus on the individual patient, and researchers, who must focus on improving the health of the population at large. Indeed, government regulators and nongovernmental entities promulgating rules of scientific research ethics share these same goals: protecting individuals, on the one hand, and improving overall health and medical knowledge on the other. The resulting principles have therefore tried to mediate the tension between individuals and the (p. 297) population by affirming that individuals cannot be treated as mere instruments to serve the greater good, stressing instead the protection of individual autonomy through voluntary participation in research. Later, the research ethics principles, like U.S. law, came to include a requirement of peer review and approval of research protocols (for example, through institutional review boards) as an additional procedural safeguard.

III Challenges

Because life-saving therapies are often both expensive and lacking in assurances of safety and efficacy, they raise numerous challenges for regulators and policy-makers. One of the most widely discussed challenges is distributive justice: by what means should we decide who gets access to these expensive drugs, given limited societal healthcare resources? In addition, the newness of the therapies and the often desperate situations in which patients find themselves may raise questions about the ability of patients to give fully informed consent to new and experimental treatments. The opportunity to undergo experimental treatments may thus pose a threat to patient autonomy. At the same time, regulatory and financial barriers that put innovative therapies off limits may pose a threat to patient autonomy from the opposite direction: they may leave patients unable to exercise true autonomy in healthcare decision-making. Finally, new and experimental therapies raise questions concerning the institutional competency of government regulators and other governmental decision-makers, who are often, but not always, the gatekeepers that control access to new therapies.

a. Equity and Distributive Justice

Innovative therapies sharply raise a problem that afflicts healthcare more generally as well: determining the proper allocation of scarce healthcare resources. Some treatments are so expensive that only the wealthiest individuals could afford to pay for them out-of-pocket; for all others, private or public insurers will inevitably be forced to make rationing decisions. Such a system sets up the specter of distributing life-saving healthcare on the basis of wealth—an unappealing notion, to say the least.17 Health disparities due to economic inequality are particularly stark in the developing world, for example, in part due to the economic incentives that drive the pricing structure of pharmaceuticals.18 Thus, some degree of rationing seems to be both a useful and an inevitable way of dealing with limited healthcare resources.

(p. 298) Yet, rationing is itself controversial. Indeed, Oregon’s prioritized list for Medicaid coverage provoked controversy when it was first established, because it was viewed as an instance of healthcare rationing, particularly for the poor. Full-fledged embrace of a rationing regime would seem to fly in the face of an implicit but widely embraced moral imperative to preserve human life at any cost, without making distinctions respecting quality of life.19 Even setting this fundamental moral impulse aside, or assuming a just and egalitarian method of rationing could be identified, skepticism about the competence and motives of the rationers—whether government agencies or private insurers—further complicates the possibility of rationing in a transparent fashion. Finally, it must be noted that rationing itself entails significant political, social, and administrative costs.20

b. Autonomy

New and innovative therapies also create challenges for patient autonomy. Truly informed consent can be elusive even under optimal conditions, but patients in desperate circumstances, faced with incomplete information about new or experimental treatment options, are particularly ill-situated to make fully informed choices.21 Indeed, the flip side of patient autonomy to choose medical treatment is the need to protect patients from untested and possibly unregulated drugs and procedures.

In the United States, a complex regulatory regime attempts to ensure that informed consent is achieved as fully as possible in certain contexts, such as federally funded clinical research involving human subjects.22 But not all experimental treatment occurs within those confines. For example, in 2005, private physicians developed a nonsurgical therapy using stem cells, which they used to treat orthopedic pain and degeneration. Until the federal Food and Drug Administration successfully sought to exercise jurisdiction over the stem cell procedure, it was practiced without any regulatory oversight.23

Autonomy concerns may arise in the context of clinical trials, as well. Patients have begun militating for continued access to experimental and unapproved drugs even after the end of the trial, for example—a problem that is largely unaddressed by research regulations in the United States.24 Patients often reasonably expect that, at least when they receive a benefit from the drug, they will be allowed to continue it indefinitely after the trial is complete. Indeed, in some cases, informed consent documents and research protocols explicitly (p. 299) promise continuing access to the therapies that prove beneficial.25 Relatedly, in the case of Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, terminally ill patients who were not themselves participants in clinical trials unsuccessfully sought access to experimental drugs that had not yet completed the FDA testing and approval process, based in part on their constitutional autonomy rights.26 Thus, the need to respect autonomy gives rise to potentially conflicting demands in this context—requiring protection of patients who may not be well positioned to provide fully informed consent but eschewing paternalism toward terminally ill patients who have little left to lose and wish to take their chances on a possibly beneficial therapy.

c. Institutional Competency and the Role of Government

Determining the proper role of government actors in regulating access to experimental and innovative therapies also presents challenges. Even bracketing the problems raised by rationing, there are other ways in which the various government institutions responsible for setting the conditions and limits of access to experimental drugs and therapies may lack the competency to do so. To begin with, courts are regularly called upon to decide on insurance coverage of experimental treatments. They may also have to decide whether patients have a right to access experimental drugs outside of the clinical trial context, whether on contract, estoppel, or constitutional theories. Yet, as noted above, judicial decision-making is unavoidably ad hoc and particularized; judges can only decide the case before them, and the broader public health and public policy consequences of permitting access to an unapproved therapy in a particular instance may fall into the background, as the suffering of an individual plaintiff is foregrounded. Moreover, judges are famously generalists and therefore possibly ill-equipped to analyze highly technical medical or epidemiological information. Finally, the quality of the decision-making is dependent on the quality of the evidence before the court, which in turn depends upon the abilities and motivation of the attorneys in any given case.

A logical solution may be to devolve decision-making to specialized agencies; however, this solution is also imperfect. Though they possess relevant technical expertise, agencies are susceptible to charges of capture and even political bias. For example, political controversy attended FDA decision-making about the over-the-counter availability of emergency contraception, as evidence-based decisions about the drug’s availability made by scientists within the agency were twice overruled by political appointees.27 Similar (p. 300) charges of political decision-making have surrounded the repeated rejection of petitions to reschedule cannabis as a less-restricted drug under federal law. Growing discontent has led to the adoption of ballot initiatives in several states making marijuana legal for medical uses, and in some cases for nonmedical uses, despite the continuing federal prohibition.

To allay concerns about the competence and incentives of the various institutions involved, an alternate model would be to loosen regulation and leave availability of new therapies to the market to decide, at least to a significant degree. However, market incentives are particularly skewed in this context, such that they are highly unlikely to result in a fair or efficient allocation of healthcare resources. For example, patients receiving an experimental drug in the context of a clinical trial may have an incentive to continue the therapy after the end of an inconclusive trial if they believe the drug has been beneficial; the drug’s manufacturer, however, may lack an incentive to make the drug available if its therapeutic applications turn out to be too limited to make it profitable. Patients, particularly those in dire circumstances, tend to be relatively inattentive to cost, as are their physicians, whereas manufacturers are arguably overly attentive to economic concerns. Moreover, pharmaceutical companies stand to gain much more from selling costly, highly profitable drugs to wealthy and insured patients in the developed world than from dealing with the most pressing public health concerns. Thus, the vast majority of private research and development dollars are currently directed toward illnesses that account for only a very small percentage of the global disease burden.28

IV Frameworks

Within American law, there are the multiple approaches to the problems posed by new, experimental, and life-saving therapies. Each approach grapples with the problems described above, though each emphasizes some over others, with greater or lesser degrees of success in resolving them. First, the constitutional framework focuses on a “negative right to health” or a right to “medical self-defense”; it is primarily concerned with circumscribing the role of the government in mediating access to potentially beneficial therapies. The public health framework, by contrast, emphasizes the role of the state in protecting the health and safety of the populace over individual rights claims; this approach to regulation may best be described as “biopolitical,” to borrow a term from Michel Foucault, meaning that it views one of the primary functions of the state to be the management of individuals’ health, physical capacity, and reproduction29. Finally, the ethics and human rights frameworks attempt to combine distributive justice and positive rights of access with respect for individual autonomy. Since no one approach dominates, conflicts over healthcare allocation continue to play out simultaneously on the national political stage, as well as in individual judicial fora.

(p. 301) a. The Constitutional Framework

American constitutional law has long resisted recognizing positive rights or entitlements to government services flowing from the existence of constitutional rights. It has, however, implicitly recognized a right to make medical treatment decisions—or at least some of them—free from governmental interference.30 Alternately, the right can be conceived as a right to “medical self-defense,” with affiliations to the common-law and now constitutional self-defense right, when one’s life or health is seriously threatened.31

The existence of this right has long been assumed, even if its contours are unclear. Indeed, some of the earliest individual rights claims to be asserted in the twentieth century involved a claimed right to resist compulsory vaccination, often because of fears about vaccination’s health effects, and to make medical care decisions free from governmental interference.32 In Cruzan v. Director, Missouri Department of Health, the U.S. Supreme Court obliquely acknowledged the existence of a constitutional right to refuse medical treatment, finding its origins in the common-law recognition of unwanted treatment as a battery or as a violation of informed consent.33

The right to access experimental or life-saving treatments may be inferred from this constitutional right, together with the more general substantive due process right to privacy. Indeed, the early cases identifying a right to privacy and autonomy—that is, a right to freedom from governmental interference in important personal decisions involving procreation—arose, after all, in the context of medical decision-making. In particular, Roe v. Wade’s emphasis on the medical aspects of abortion has been widely noted; Roe can thus be understood as a case about, among other things, the constitutional right to access medical treatment and make health-related decisions autonomously. Even more to the point, an unbroken line of abortion cases from Roe onward has recognized that women have a right to choose abortion, even after the fetus is viable, when the procedure is necessary to preserve her life or health.34 Given that the state’s interest in a viable fetus is considered to be compelling, the fact that the woman’s right to protect her own health is sufficient to overcome that state interest indicates that the right is an extraordinarily robust one.

The question remains, however, how far this right extends. Courts have generally proven unsympathetic to other sorts of claims by plaintiffs seeking to assert a right to access a particular therapy in the face of legal prohibitions. As discussed in section IV.b., the persistence of the public health approach may be one reason for this. Thus, claims for access to (p. 302) experimental and unapproved therapies such as medical marijuana and laetrile (or amygdalin, a substance found in apricot pits believed by some to be a treatment for cancer) were consistently turned away without any serious credence being given to the constitutional claims at issue. Nonetheless, advocates continue to present claims of a constitutional right to access medical treatment without government interference. In the closely watched Abigail Alliance case, the plaintiffs claimed a substantive due process right to access new drugs that had completed only the first stage of clinical trials. Although the D.C. Circuit court of appeals initially recognized “a right of terminally ill patients to make an informed decision that may prolong life,” it later reversed itself.35 Rather than weighing the patients’ interests in health and bodily integrity against the asserted state interests in ensuring the drugs’ safety and efficacy, the court simply held that there was no constitutional right to access unapproved drugs.36 Thus, this constitutional right remains one of uncertain standing.

Of the various challenges for dealing with access to experimental treatments, the constitutional framework is most clearly focused on autonomy. It generally balances individuals’ interest in protecting their health and making important healthcare choices without government interference against the state’s interests, such as the state interest in ensuring the safety and efficacy of drugs that are made available to the public. In Cruzan, a case dealing with whether care should be continued for a patient in a persistent vegetative state when some evidence indicated that she would have wanted care to be terminated, the Supreme Court explicitly balanced the individual’s right to refuse health care against the state’s interests in protecting vulnerable individuals37. Similarly, the original panel in Abigail Alliance clearly contemplated such balancing—a balancing that could ultimately weigh against access to unapproved drugs that had completed only the first phase of clinical trials.38 Given the relatively sparse jurisprudence on this issue and the fact that every claim of access to unapproved medicines has ultimately been rejected by the courts, it is difficult to say exactly how the constitutional balance would be struck, if courts were to recognize a right to protect one’s health outside the reproductive health context. Beyond concerns about the safety and efficacy of particular drugs—concerns that are arguably minimal with respect to terminally ill patients for whom all other therapies have failed—the balancing would have to take account of the broader risks posed by access to experimental therapies outside the clinical trial context. In particular, it might be argued that patients would have little incentive to participate in clinical trials, in which they may be assigned to the control group that receives only a placebo rather than the potentially efficacious drug, if they can gain access to the drug through constitutional litigation. If patients no longer sign up for clinical trials, the entire system for testing and approval of new drugs could unravel. Such concerns may be sufficient to outweigh any individual interest in accessing unapproved drugs, except in the most extreme circumstances.

(p. 303) Because the U.S. constitutional framework is a negative one, equality concerns are not directly addressed: there is no affirmative right to government assistance or subsidy for healthcare in the negative model, which comprises only a right to avoid government interference with healthcare decisions. Although equal protection norms would generally forbid discriminatory distribution of healthcare resources along racial, ethnic, religious, or gender lines, ability to pay is largely irrelevant to the constitutional framework. Thus, if patients are unable to access needed healthcare due to a lack of financial resources, the constitutional framework will not provide a basis for relief: it is the individual’s own indigence, not government action, that creates the obstacle to access.39

Finally, the constitutional framework implicitly assumes that the institution most suited to decide individual access claims is the judiciary. Constitutional rights claims by nature call on the courts as ultimate arbiters, since successful constitutional claims trump law enacted by the legislature. Thus, the question whether a constitutional right to make medical treatment decisions should be recognized impliedly raises the question whether the judiciary is the right institution to make decisions about access to experimental or life-saving therapies. Institutional-competence questions such as these tend to be underemphasized in constitutional argument, however, in favor of argument about the normative desirability of the substantive right itself.40

b. The Public Health Framework

Coexisting with the constitutional framework is the public health framework, which emphasizes the police power of the state and the government’s traditional role in safeguarding the public’s health and safety. Included within that traditional role, virtually since the beginning of modern medicine, is the power to regulate medical practice and practitioners. Thus, U.S. law has long placed claims of access to medical therapies in the context of the broad power and discretion granted to the state to decide best how to protect the public. This tradition coexists uncomfortably alongside the more recent recognition of a constitutional right to make certain medical treatment decisions.

The early twentieth-century case of Jacobson v. Massachusetts exemplifies the public health framework. In that case, Henning Jacobson had refused to be vaccinated against smallpox, despite a city ordinance requiring virtually universal vaccination and imposing criminal penalties for refusal. He claimed that the Constitution gave him the right “to care for his own body and health in such way as to him seems best.”41 The U.S. Supreme Court flatly rejected this individual rights claim, focusing instead on the state’s power to protect the public. Taking a population view rather than an individual rights view, the Court insisted that “the rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand.”42 The claim of the individual simply gave way in the face of a claim of public necessity; no meaningful balancing or scrutiny was required.

(p. 304) This line of thinking persists in American law, though little effort has been made to reconcile it with the constitutional framework. For example, in Eisenstadt v. Baird, the case in which the Supreme Court recognized the right of unmarried persons to access contraceptives and the “right of the individual, married or single, to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child,” the dissent embraced the public health view.43 Chief Justice Burger emphasized the state’s traditional role and prerogative in regulating medicine and protecting health.44 Similarly, the lower court in Griswold v. Connecticut had dismissed the claim of a constitutional right to access contraception, stating, “[C]‌ourts may not interfere with the exercise by a state of the police power to conserve the public safety and welfare … if the law has a real and substantial relation to the accomplishment of those objects. The legislature is primarily the judge of the regulations required… . ”45

Claims of access to experimental and unapproved therapies are mostly treated under this public health framework, as demonstrated by the Supreme Court’s cursory dismissal of patients’ claimed right to access to laetrile in United States v. Rutherford.46 Suits for access to cannabis for medical use and to drugs that have passed only Phase I clinical trials have been treated similarly by lower courts.47

Several features characterize the public health approach. The public health approach is biopolitical in nature; it views the primary purpose of the state as both protecting and managing human health and physical well-being.48 The public health approach operates primarily at the population level: biopolitics, like public health but in contrast to the constitutional framework, focuses primarily on statistics and large groups, not individuals and their particular health needs.49 Moreover, the biopolitical public health framework is not merely a negative one, intent on preventing harm and disease. It is also a positive approach to governing, explicitly concerned with improving health and lengthening the average lifespan and quality of life.50 Thus, for example, the public health approach to access to experimental therapies emphasizes the role of the FDA in protecting the public from unsafe and ineffective drugs, but it is also attentive to the FDA’s role in facilitating the approval of new drugs to improve health, which must be protected by avoiding any approach that would permit widespread access to unapproved drugs outside the carefully controlled clinical trial process or its limited exceptions, such as compassionate use.

(p. 305) Thus, in contrast to the constitutional framework, the public health framework minimizes the importance of individual autonomy in favor of protecting the public.51 The principal autonomy concern for the public health framework is that of ensuring that meaningful informed consent to experimental treatment can be obtained in the face of patients’ desperation, their possibly unrealistic expectations of miracle cures and, occasionally, political rhetoric that overstates the benefits and understates the potential harm of experimental drugs.52

However, the public health approach is more likely than the constitutional framework to be attentive to concerns of equity and distributive justice, albeit not always explicitly. Because the public health framework is concerned with the distribution of healthcare resources across a population, the primary goal is to determine how resources may be allocated most effectively—that is, to identify the allocation of resources that will provide the largest public health benefit per governmental dollar spent. Unsurprisingly, such an approach would tend to disfavor expensive and untested new therapies and favor alleviating the most common and most treatable diseases in the developing world.53 Given that decisions must be made on a population level rather than on an individual case-by-case basis, questions about the fairest allocation of resources are easily built into the public health calculus.

The public health approach, too, includes certain implicit assumptions about which institutions are best suited to make decisions regarding access to experimental and life-saving medical treatment. The biopolitical state is heavily reliant on more or less independent agencies to gather, study, and analyze vast amounts of data, embracing the disciplines of epidemiology and demography, among others. Thus, the public health framework gives priority to the FDA and other specialized agencies in the functions of coordinating and implementing access to new and innovative therapies. Additionally, the legislative arm of the state retains the power and duty to protect the public health. However, the judiciary and the various players in the marketplace—pharmaceuticals manufacturers, physicians, and patients—are seen as too limited and individualized in their focus to make decisions that will best serve the collective good; as such, their decision-making must be subject to oversight. For this reason, too, individual rights are often given less weight than the state’s interests in health and safety.

Finally, the public health framework has traditionally assumed a second kind of institutional division of labor. It assumes a federalist approach to protecting health: the state is charged with the regulation of the medical profession and medical practice, whereas the federal government regulates the sale and marketing of innovative drugs and devices that move in interstate commerce. This has long been the classic structure of American health regulation. Yet, there is reason to doubt the durability of this traditional model. The adoption of the Affordable Care Act, including the expansion of Medicaid, appears to have enlarged the federal government’s role in the regulation and delivery of healthcare. At the same time, recent cases recognize a wide scope for federal preemption of state laws by means of federal (p. 306) labeling and safety standards.54 Thus, it may be that the future of federalism in healthcare is uncertain.

c. The Ethics and Human Rights Frameworks

The ethics and human rights framework in fact comprises two related approaches, both of which are fundamentally concerned with fairness and with the dignity of the individual. The ethics framework, which dominates the field of bioethics in the United States, is built around four fundamental principles: autonomy, beneficence, nonmaleficence, and justice.55 These principles, too, arguably originated with the Nuremberg Code. The first of the ten Nuremberg Code principles is that the patient must voluntarily consent to the experiment; this aligns with the bioethics principle of respect for patient autonomy. Similarly, the Nuremberg Code embodies the principle of beneficence by requiring that experiments must benefit society and cannot be random or unnecessary. Finally, several of the Nuremberg Code requirements forbid causing harm to the subject; this aligns with the nonmaleficence principle. Thus, the origins of bioethics appear to lie in human rights concerns about protecting patients in the context of experimental therapies.

While compatible with the ethics framework, the human rights approach tends to take a more international perspective, considering the global impact of particular health policy decisions with respect to experimental therapies. The human rights approach to healthcare is characterized by the recognition of a universal right to health, understood as a positive entitlement to at least some of the elements necessary to achieving a state of health, along with the fundamental principles of equality and nondiscrimination. Thus, numerous treaties and many national constitutions drafted in the modern era specify a right to health, which is generally understood to mean a right “of everyone to the highest attainable standard of physical and mental health.”56 This may imply a right of access to some life-saving treatments and some experimental treatments outside the context of clinical trials. In addition, the emphasis on the right “of everyone” to health denotes a requirement of moral fairness in the allocation of healthcare resources. However, one of the difficulties in fulfilling the promise of the human right to health is precisely the indeterminacy and potential breadth of the term “health.”

With respect to innovative, experimental, and life-saving therapies, the human rights framework is represented by numerous documents including the Nuremberg Code, the Helsinki Declaration, the U.N. Universal Declaration on Bioethics and Human Rights, and the U.N. Human Rights Guidelines for Pharmaceutical Companies, in Relation to Access (p. 307) to Medicines. As the last document in particular indicates, the human rights obligation to safeguard the right to health is not limited to states; private parties such as pharmaceutical manufacturers share in this duty. In addition, those documents share, in common with the ethics framework, a focus on protecting patient autonomy and well-being.

Because of its global focus, the human rights framework is particularly relevant to controversies involving experimental therapies abroad. For example, the rise of medical tourism, in which patients travel abroad for medical treatment, may result in profound healthcare inequities. Patients may engage in medical tourism to access procedures they would be prohibited from accessing in their home country (for example, in vitro fertilization, stem cell therapies, or experimental drugs), or in order to access healthcare services that may be legal in their home country but so expensive as to be out of reach. Because patients from developed countries who travel to developing countries are usually willing and able to pay a much higher price for medical services than the destination country’s residents, healthcare providers have an incentive to serve as many tourists as possible, while limiting the care provided at a lower cost to their fellow citizens. In addition, the lucrative practice of medical tourism may even result in poorer nations investing public dollars in expensive, cutting-edge healthcare technologies that will inevitably be beyond the financial reach of their citizens.57

Another pressing controversy to which the ethics and human rights framework is often applied is the conduct of clinical trials abroad—particularly clinical trials of new drugs by U.S. or European pharmaceutical researchers in the developing world. In some cases, researchers have been accused of taking advantage of another country’s less patient-protective legal standards and needier patient population in order to conduct trials that would not be permissible at home. The temptation to go abroad to recruit clinical trial participants is particularly great in light of Americans’ increasing reluctance to participate in clinical trials and the need for large numbers of subjects in order to pass the three phases of clinical trials required for FDA approval.58 The practice of conducting clinical trials in developing countries raises questions about whether subjects are truly giving voluntary consent, when in many cases no other healthcare may be available for them. It also raises questions about the researchers’ and manufacturers’ duty to extend post-trial access to subjects who otherwise have little or no access to effective treatment. Finally, standards for the ethical design of clinical trials in developing countries must be considered. For example, federally sponsored researchers controversially conducted placebo-controlled trials of a drug to reduce mother-to-child transmission of HIV in developing countries in Africa, Asia, and the Caribbean. The use of placebos was ethically questionable, because another effective (but expensive) treatment was known.59

Because the human rights and ethics frameworks foreground equality and distributive justice, controversies concerning medical tourism and clinical trials in the developing world must be resolved with a goal of recognizing human dignity and the equal entitlement of all (p. 308) persons to a standard of health, however defined. For example, denying post-trial access to drugs arguably constitutes exploitation of trial subjects—treating them “as mere means to the end of testing a drug.”60 This is especially true in cases where the therapy being tested, if proven effective, is likely to be unaffordable for the vast majority citizens of the country in which it was tested. In Brazil, which recognizes a fundamental constitutional right to health, courts have thus enforced a right to post-trial access and have required pharmaceutical companies to foot the bill.61 Furthermore, the Helsinki Declaration requires—at least presumptively—that trials be conducted in compliance with the ethical standards of both the sponsoring country and the country that is the site of the trials, as well as that placebos not be used for testing new therapies when another effective treatment exists.62

But at the same time, the requirements of equality and justice may not always be straightforward. Controversies over access to treatment often involve conflicting interests and incentives. For example, while post-trial access to drugs may serve the interests of justice for individual subjects, recognizing a broad right to post-trial access may undermine the entire system of randomized, controlled clinical trials. Moreover, if pharmaceutical companies are forced to bear the costs of post-trial access, they may decline to conduct trials in that country altogether; at the same time, in cases where the experimental therapy is proven to be effective but financially out of reach for most citizens, it seems unfair to award access only to certain individuals because they had the good luck to be chosen to receive it in the context of a clinical trial. Similarly, though the potentially negative consequences of medical tourism may militate in favor of heavily regulating or even outlawing it, global justice also requires recognition that host countries may benefit economically from it, and in some cases the benefits may outweigh the costs. Nonetheless, the ethics and human rights framework engages productively with these difficult questions. Moreover, some innovative solutions have been proposed or adopted, such as compulsory drug licensing, which is already in use in numerous countries, and the Health Impact Fund, which would provide financial rewards for drug companies whose products have a meaningfully positive global health impact.

Autonomy is an equally important value in the ethics and human rights frameworks. Because of the ethics and human rights frameworks’ attentiveness to global disparities in wealth and bargaining power, they also recognize that autonomy is inextricably intertwined with the values of equality and justice. This concern is particularly visible in the overriding focus of the Nuremberg Code, the Helsinki Declaration, and other such documents on informed consent and preventing exploitation of vulnerable populations. In general, the human rights approach combines robust protection for individual autonomy in the form of a right to access necessary healthcare—essentially, both a negative and a positive right to health—with the recognition that individual decision-making may be influenced by economic circumstances in ways that may place a particularly heavy responsibility on researchers and drug manufacturers for ensuring true and voluntary informed consent. Moreover, (p. 309) it is at least due to the principles embraced by the ethics and human rights frameworks that the use of independent ethics committees, such as institutional review boards, is required in connection with research on human subjects. The use of such committees, which is required by the Helsinki Declaration and by federal regulations, is intended to ensure that research on human subjects is conducted ethically, with respect for the autonomy and well-being of those subjects.

Institutional competency concerns are the least comprehensively addressed challenge within the ethics and human rights frameworks. Rather, the human rights and ethics frameworks draw on a mix of courts, legislatures, international bodies, and even private actors to determine, operationalize, and regulate access to experimental and life-saving treatments. The overriding mandate is to serve the substantive ends of justice, rather than to respect preexisting institutional constraints or to maximize efficiency.

V Conclusion

In combination, the ethics and human rights frameworks are the most promising. They address all three challenges of access to new, experimental, and life-saving therapies in a comprehensive and nuanced manner, with attention to the implications of decisions about access to healthcare not just in the United States but also globally. This global focus is appealing, because it fills an apparent normative gap in the constitutional and public health frameworks. Given the increasing globalization of both the economy in general and the healthcare sector in particular, it is of pressing importance to consider how health conditions abroad impact healthcare and economics at home. In addition, an important strength of the ethics and human rights frameworks is that they combine a focus on equality with a deep concern for autonomy. The ethics and human rights frameworks insist on distributive justice, while making room for cost-benefit analysis and for creative solutions to the severe and growing problem of health disparities.

To some degree, the ethics and human rights frameworks have been embraced in American healthcare law and policy. The Affordable Care Act may be viewed as an initial step, however tentative, toward elaborating a positive statutory right to healthcare in the United States. Furthermore, widespread recognition of human rights abuses flowing from unethical, federally sponsored research—such as the syphilis experiments in Guatemala in the post-World War II era and those at home in Tuskegee, Alabama from 1932 to 1972—has led to the adoption of mandatory ethics standards for the conduct of clinical trials, including the requirement of institutional review board approval. For the most part, however, the ethics and human rights frameworks, while somewhat influential, do not command the force of law in the United States. The Nuremberg Code and Helsinki Declarations are nonbinding, and no positive constitutional right to health has been recognized.

Thus, although the ethics and human rights frameworks are the most promising solution to the pressing challenges surrounding access to experimental and life-saving therapies, they are the least likely to be adopted in the United States. Indeed, the FDA has moved away from requiring international research accepted by the agency to adhere to the relatively restrictive ethical prescriptions of the Helsinki Declaration, issuing a rule in 2009 that sanctioned the alternative, less restrictive good clinical practice (GCP) regulations created (p. 310) by the International Conference on Harmonisation. The GCP regulations do not address some of the issues that are particularly germane to the ethics and human rights frameworks, such as the use of placebos and post-trial access. In addition, the ethics and human rights frameworks are generally less attentive to institutional issues, such as separation of powers and institutional competency, that are often central to American legal discourse. Finally, the documents that outline the ethics and human rights approaches lack enforcement mechanisms, and positive-rights jurisprudence and rhetoric have yet to gain a foothold in the United States. Once again, politics is shown to be inseparable from healthcare.

Notes:

(1) See, e.g., Steven Joffe, Evaluating Novel Therapies During the Ebola Epidemic, 312 JAMA 1299, 1299 (2014).

(2) See, e.g., B. Jessie Hill, What Is the Meaning of Health? Constitutional Implications of Defining “Medical Necessity” and “Essential Health Benefits” Under the Affordable Care Act, 38 Am. J. L. & Med. 445 (2012) (noting the traditionally decentralized nature of medical decision-making and discussing the implications of the move toward a more centralized system with the Affordable Care Act).

(3) Dale Cowan, Innovative Therapy Versus Experimentation, 21 Tort & Ins. L.J., 619, 622–623 (1986)).

(4) Richard S. Saver, Reimbursing New Technologies: Why Are The Courts Judging Experimental Medicine?, 44 Stan. L. Rev. 1095, 1096 & n.6 (1992).

(5) See The Kaiser Commission on Medicaid and the Uninsured, Medicaid: A Primer v-16 (2013), available at http://kff.org/medicaid/issue-brief/medicaid-a-primer/.

(6) See, e.g., Rush v. Parham, 625 F.2d 1150, 1156 (5th Cir. 1980); Oklahoma Chapter of the American Academy of Pediatrics v. Fogarty, 366 F. Supp. 2d 1050, 1117 (N.D. Okla. 2005); McLaughlin v. Williams, 801 F. Supp. 633 (S.D. Fla. 1992).

(7) The American Medical Association defines medical necessity as: “Health care services or products that a prudent physician would provide to a patient for the purpose of preventing, diagnosing or treating an illness, injury, disease, or its symptoms in a manner that is: (a) in accordance with generally accepted standards of medical practice; (b) clinically appropriate in terms of type, frequency, extent, site, and duration; and (c) not primarily for the economic benefit of the health plan and purchasers or for the convenience of the patient, treating physician, or other health care provider.” American Medical Association, Statement of the American Medical Association to the Institute of Medicine’s Committee on Determination of Essential Health Benefits 3 (Jan. 14, 2011), available at http://www.iom.edu/~/media/Files/Activity%20Files/HealthServices/EssentialHealthBenefits/2011-JAN-13%20and%2014/Gerald%20Harmon%20Statement.pdf. For private insurers, too, the term “medically necessary” is generally used to describe medical treatment that is appropriate and rendered in accordance with widely accepted standards of medical practice. Gillian I. Russell, Terminology, in Fundamentals of Health Law 1, 25 (5th ed. 2011).

(8) Einer Elhauge, Allocating Health Care Morally, 82 Cal. L. Rev. 1449, 1467 (1994).

(9) M. Gregg Bloche, The Hippocratic Myth: The Hippocratic Myth: Why Doctors Are Under Pressure to Ration Care, Practice Politics, and Compromise their Promise to Heal 11 (2011).

(10) 42 U.S.C.A. §18022(b)(1).

(11) See, e.g., Thomas Bodenheimer, The Oregon Health Plan—Lessons for the Nation, 337 JAMA 651, 651 (1997). The list was actually created by the Oregon Health Services Commission, which reported to the governor, acting under a mandate from the state legislature. See Or. Rev. Stat. § 414.720. The plan’s medical directors were also empowered to authorize payment for below-the-line treatments on a case-by-case basis. Bodenheimer, The Oregon Health Plan, at 654.

(12) For example, “health” is sometimes defined in the United States to include mental and emotional health, as well as social factors. Doe v. Bolton, 410 U.S. 179, 192 (1973); United States v. Vuitch, 402 U.S. 62, 71–72 (1971). In international human rights scholarship, much attention is given to the role played by social determinants in achieving a state of health. See, e.g., Thana Cristina de Campos, Health as a Basic Human Need: Would This Be Enough?, 40 J.L. Med. & Ethics 251, 252 (2012).

(13) Saver, Reimbursing New Technologies, at 1113–1114 (discussing Rollo v. Blue Cross-Blue Shield of New Jersey, 1990 WL 312647 (D.N.J. Mar. 22, 1990)).

(14) Leonardo Cubillos et al., Universal Coverage and Litigation in Latin America, 26 J. Health Org. & Mgmt. 390, 395, 401–402 (2012) (noting that, in 2009, one municipality in Brazil spent 16% of its entire health budget to treat eighty-six new patients as a result of litigation, and that Colombia used 5% of its national health budget to pay for individual right-to-healthcare suits).

(15) See, e.g., Wendy E. Parmet, From Slaughter-House to Lochner: The Rise and Fall of the Constitutionalization of Public Health, 40 Am. J. Legal Hist. 476, 478–479 (1996).

(16) See, e.g., Maxwell J. Mehlman, Quackery, 31 Am. J.L. & Med. 349, 350 (2005).

(17) Indeed, the Canadian province of Québec attempted to avoid this problem and ensure that healthcare resources would be distributed primarily on the basis of need rather than wealth, by adopting prohibitions on private insurance for healthcare services. Those prohibitions were held unconstitutional by the Canadian Supreme Court in Chaoulli v. Québec, [2005] 1 S.C.R. 791 (Can.).

(18) Anand Grover, Brian Citro, Mihir Mankad, & Fiona Lander, Pharmaceutical Companies and Global Lack of Access to Medicines: Strengthening Accountability under the Right to Health, 40 J.L. Med. & Ethics 234, 235 (2012).

(20) Maxwell J. Mehlman, Rationing Expensive Lifesaving Medical Treatments, 1985 Wis. L. Rev. 239.

(21) See, e.g., George J. Annas, Faith (Healing), Hope and Charity at the FDA: The Politics of AIDS Drug Trials, 34 Vill. L. Rev. 771, 775–778 (1989).

(22) See, e.g., Protection of Human Subjects, 45 C.F.R. § 46 (2005), available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. See also Informed Consent of Human Subjects, 21 C.F.R. § 50.20 (2011), available at http://www.gpo.gov/fdsys/pkg/CFR-2000-title21-vol1/content-detail.html.

(23) United States v. Regenerative Sciences, LLC, 741 F.3d 1314, 1317–1318 (D.C. Cir. 2014).

(24) Richard S. Saver, At the End of the Clinical Trial: Does Access to Investigational Technology End as Well?, 31 W. New Eng. L. Rev. 411, 426 (2009). However, FDA regulations do contain provisions for “compassionate use,” allowing access to unapproved drugs by individuals with severe or life-threatening conditions and no other suitable treatment options. See Expanded Access to Investigational Drugs for Treatment Use, 21 C.F.R. § 312.300 (2009).

(25) See, e.g., Abney v. Amgen, Inc., 443 F.3d 540, 544 (6th Cir. 2006); see also Saver, At the End of the Clinical Trial, at 429.

(26) 495 F.3d 695, 717 (D.C. Cir. 2007) (Rogers, J., dissenting).

(27) In 2005, the FDA commissioner delayed making emergency contraception available over the counter despite a positive recommendation by the FDA’s Center for Drug Evaluation and Research. Susan F. Wood, The Role of Science in Health Policy Decision-Making: The Case of Emergency Contraception, 17 Health Matrix 273, 284 (2007). Then, in 2011, the director of the Department of Health and Human Services overruled the FDA’s decision that the drug could be made available over the counter to minors. Gardiner Harris, Plan to Widen Availability of Morning-After Pill Is Rejected, N.Y. Times, Dec. 11, 2011, available at http://www.nytimes.com/2011/12/08/health/policy/sebelius-overrules-fda-on-freer-sale-of-emergency-contraceptives.html?_r=0.

(29) Michel Foucault, 1 The History of Sexuality 135–159 (Robert Hurley trans., 1978).

(30) See, e.g., B. Jessie Hill, The Constitutional Right to Make Medical Treatment Decision: A Tale of Two Doctrines, 86 Tex. L. Rev 277 (2007); John A. Robertson, Embryo Culture and the “Culture of Life”: Constitutional Issues in the Embryonic Stem Cell Debate, 2006 U. Chi. Legal F. 1 (2006).

(31) District of Columbia v. Heller, 554 U.S. 570, 635 (2008) (recognizing a constitutional right to possess a handgun for self-defense); Eugene Volokh, Medical Self-Defense, Prohibited Experimental Therapies, and Payment for Organs, 120 Harv. L. Rev. 1813 (2007).

(32) Michael Willrich, Pox: An American History 14 (2011).

(33) Cruzan v. Director, Mo. Dep’t of Health, 497 U.S. 261, 277–279 (1990).

(34) Although the Supreme Court declined to strike down a federal law banning a particular abortion procedure for lack of a health exception in Gonzales v. Carhart, 550 U.S. 124 (2007), it upheld the law only because it found that facial invalidation would be inappropriate in light of medical disagreement over whether the procedure was ever medically indicated, id. at 163. It nonetheless assumed that any abortion regulation creating significant health risks for women would be unconstitutional. Id. at 161.

(35) Abigail Alliance for Better Access to Developmental Drugs & Washington Legal Found. v. von Eschenbach, 445 F.3d 470, 477 (D.C. Cir. 2006), vacated on reh’g en banc sub nom. Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007).

(36) Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695, 707 (D.C. Cir. 2007).

(37) Cruzan v. Dir., Missouri Dep’t of Health, 497 U.S. 261, 279 (1990).

(38) Id. at 715 (Rogers, J., dissenting) (citing Abigail Alliance, 445 F.3d 470, 486 (D.C. Cir. 2006), vacated upon grant of rehearing en banc by Abigail Alliance, 495 F.3d 695).

(39) See Maher v. Roe, 432 U.S. 464, 474 (1977).

(40) See generally Andrew B. Coan, Is There a Constitutional Right to Select the Genes of One’s Offspring?, 63 Hastings L.J. 233 (2011).

(41) Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11, 26 (1905).

(42) Id. at 29.

(43) Eisenstadt v. Baird, 405 U.S. 438, 453 (1972).

(44) Id. at 465–472 (Burger, C.J., dissenting).

(45) State v. Griswold, 200 A.2d 479, 480 (1964), rev’d, 381 U.S. 479 (1965).

(46) 442 U.S. 544 (1979).

(47) See, e.g., Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007); Raich v. Gonzales, 500 F.3d 850, 864–866 (9th Cir. 2007).

(48) Michel Foucault, 1 The History of Sexuality 135–159 (Robert Hurley trans., 1978).

(49) See, e.g., Lawrence O. Gostin, Public Health Law: Power, Duty, Restraint 11–14 (2000). Indeed, Foucault suggests that the birth of the rights to privacy and bodily integrity are themselves a response to the rise of the biopolitical state. Those claimed rights are a reaction—but stated in the government’s own language, the language of rights—against the state’s seizure of control over the body and human life through its new comprehensive biopolitics. Supra note 48, at 145.

(50) Gostin, Public Health Law, at 327 (“The field of public health is purposive and interventionist. It does not settle for existing conditions of health, but actively seeks effective techniques for identifying and reducing health threats.”).

(51) See, e.g., Wendy E. Parmet, Public Health and Constitutional Law: Recognizing the Relationship, 10 J. Health Care L. & Pol’y 13, 23 (2007) (“One quick, but I think ultimately unsatisfactory, answer is that the interdependency of risk demonstrated by epidemiology argues for the need for constitutional law to give less weight to ‘individual rights’ and more leeway for government actions taken in the name of public health.”).

(53) Cf. Christopher T. Robertson, The Presumption Against Expensive Health Care Consumption, 49 Tulsa L. Rev. 101 (2014).

(54) See, e.g., Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) (holding that a patient’s state tort law claim based on inadequate warning of a generic drug’s dangers was preempted by federal labeling regulations, which prohibited unilateral alternation of a drug label); PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (finding preemption of state-law claims for brand-name drugs based on federally approved drug label); Riegel v. Medtronic, 128 S. Ct. 999 (2008) (holding that common-law claims against a medical device manufacturer were preempted by FDA requirements); But see Wyeth v. Levine, 183 Vt. 76, 944 A.2d 179 (2006), cert. granted, 129 S. Ct. 1887 (2008) (holding that state law failure-to-warn claims were not preempted by federal law).

(55) Beauchamp & Childress, Principles of Biomedical Ethics 12–13 (6th ed. 2009).

(57) I. Glenn Cohen, Medical Tourism, Access to Health Care, and Global Justice, 52 Va. J. Int’l L. 1, 3–5 (2011).

(58) See generally Adam H. Laughton, Somewhere to Run, Somewhere to Hide?: International Regulation of Human Subjects Experimentation, 18 Duke J. Comp. & Int’l L. 181 (2007).

(59) See Peter Lurie & Sidney M. Wolfe, Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries, 337 New Eng. J. Med. 853 (1997).

(60) Daniel Wei L. Wang & Octavio Luiz Motta Ferraz, Pharmaceutical Companies vs. the State: Who Is Responsible for Post-Trial Provision of Drugs in Brazil?, 40 J.L. Med. & Ethics 188, 189 (2012).

(61) Id.

(62) World Medical Association, Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, paras. 10, 33, 310 JAMA 2191 (2013). The Helsinki Declaration does permit the use of a placebo in trials, even where another effective treatment exists, if there are compelling scientific reasons for doing so and there is no significant risk to patients. Id. para. 33.