A Defense of Self-Medication by Jessica Flanigan

A Defense of Self-Medication

Jessica Flanigan

DOI:10.1093/oso/9780190684549.003.0001

I personally do not agree with a number of things  espoused in this article

Abstract and Keywords

The same considerations that justify rights of informed consent also justify rights of self-medication because paternalism is wrong at the pharmacy and in the doctor’s office. Rights of self-medication require that patients have legal access to medicines without a prescription and without authorization from a regulatory agency. Like informed consent, the right of self-medication does not rely on a single, potentially controversial normative premise. From a consequentialist perspective, patients should be entrusted with making choices for themselves because they are generally most knowledgeable about which decision will further their interests. From a rights-based perspective, medical decisions are often intimate and personal choices that are especially significant to patients. Furthermore, even if a medical choice is not intimate, personal, or especially significant, people are more generally entitled to choose how they live their lives without being subjected to benevolent interference by physicians or public officials.

Keywords:   informed consent, medical ignorance, approval requirements, prescription requirements, paternalism, bodily rights, self-medicate

Mary Schloendorff was admitted to New York Hospital in the winter of 1907, suffering from abdominal pain and indigestion.¹ Before she was discharged, a physician found a lump in her side during a physical examination. The physician, Dr. Frederick H. Bartlett, advised that Mary be examined under anesthesia to determine what the lump was. Mary replied that she did not want to undergo any operation, but Dr. Bartlett assured her that the exam was only investigational and that she could decide later if she wanted surgery. Still, Mary decided to go home and wrote to her landlady that she was returning.

The night before Mary was to leave the hospital, she was awakened several times in preparation for an examination, and each time she stated that she did not want an operation. Mary’s ability to understand her circumstances and make decisions was not impaired during this time. Nevertheless, the next morning she was physically restrained and anesthetized. When she woke up, she learned that a surgeon discovered uterine fibroids and that she had been given a supravaginal hysterectomy. Screaming in pain, she was confined to the hospital. As she recovered, Mary was transferred to a series of hospitals and convalescence homes for months. She developed painful complications related to the surgery, including the amputation of some of her fingers as a result of gangrene.

The most significant development in twentieth-century medical ethics is the rejection of medical paternalism of the sort that Mary Schloendorff experienced. Though people may disagree about how exactly to define medical paternalism, or paternalism, a fairly uncontroversial characterization is that medical paternalism consists in interference with a person’s medical choice, which is motivated or justified for her own sake, without her consent. So if interference against a person’s will is motivated or justified to promote her well-being, to protect her from injury, to make her healthier or more autonomous, or to benefit her in some other way, then it is paternalistic interference. There may be other forms (p.2)of paternalism that do not take the form of interference, such as paternalistic gift-giving, but these are not central cases. The three main ways to paternalistically interfere with a person against her will is to force, coerce, or deceive her to make her better off.

Before the twentieth century, physicians routinely deceived patients, withheld diagnoses, and even performed unwanted medical interventions. In the United States, a series of court cases, including Schloendorff’s lawsuit against New York Hospital, secured legal and professional recognition of the doctrine of informed consent. However, the rejection of medical paternalism happened gradually. A 1967 survey of internists and surgeons found that almost 90 percent of physicians had a general policy of withholding cancer diagnoses from patients.² Some even reported that they falsified diagnoses of patients in advanced-stages of their diseases.

Today, though some parts of the world still permit deception by physicians, most developed countries protect patients’ rights to be informed about treatment options and require consent for medical procedures. Even when a patient’s treatment choice is medically inadvisable, courts and physicians now recognize the principle of self-determination that Judge Benjamin Cardozo famously articulated in his opinion for Schloendorff v. New York Hospital:

Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault.³

At the same time, the twentieth century also altered the scope of patients’ rights outside the clinical context. Just as patients were gaining ever more rights as part of the newly developing doctrine of informed consent, administrative agencies began enforcing legal limits on the kinds of medicines patients could purchase and use. These limits included premarket testing requirements and the prescription drug system.

Today, pharmaceutical regulation is pervasive. In all developed countries government agencies control the drug industry at every level. As Daniel Carpenter writes, the US Food and Drug Administration (FDA) is the most powerful regulatory agency in the world, in part because “an American model for pharmaceutical regulation has been perhaps the primary institutional export of the United States.”⁴ I will therefore focus mainly on the United States because the FDA is the clear global leader in crafting legal standards for drug approval and access, (p.3) though the philosophical arguments I develop apply more generally to all administrative agencies that prohibit patients from accessing pharmaceuticals without authorization.

My thesis is that the same considerations that justify rights of informed consent also justify rights of self-medication. Paternalism is just as wrong at the pharmacy as it is in the doctor’s office. Medical autonomy is an important value in both contexts, so states should protect patients’ rights against unwanted medical interventions from physicians and from unwanted limits on access by public officials. Both informed consent requirements and rights of self-medication will permit people to make decisions that their physicians would advise against. For example, rights of self-medication would require that patients can legally purchase and use dangerous medicines without a prescription and without authorization from a regulatory agency.

This is not to say that patients should use pharmaceuticals without seeking medical advice. Patients who are interested in protecting their health should generally consult physicians and other experts on medical choices. Patients also should comply with treatment recommendations, exercise routines, and diets. Yet, in all these cases, the fact that a recommended option is better for a person’s health does not authorize physicians or public officials to force the patient to choose that option. Similarly, even when unapproved pharmaceutical use will undermine a patient’s health, it is wrong to forbid use.

Like other rights, rights of self-medication are interpersonal. So when I argue that people have a moral right to use drugs, I mean that they have rights against others who would forcibly or coercively interfere with their drug use. The right of self-medication does not establish that people have rights to inexpensive drugs or that people have rights to pharmaceutical innovation. In this way too, rights of self-medication parallel rights of informed consent and bodily rights more generally. The right of self-medication only establishes rights against public officials’ prohibition of drug sales, but a person could still lack effective access to pharmaceuticals if the drugs she needs have not yet been developed or if manufacturers are unwilling to provide her with drugs (assuming the manufacturer has a property right in the drug). Yet as I will argue, though rights of self-medication do not entail rights to access affordable drugs or rights to drug development, respecting patients’ rights of self-medication would promote innovation and could make drugs more affordable too.

Like informed consent, the right of self-medication does not rely on a single, potentially controversial normative premise. Consequentialists and non-consequentialists, liberal egalitarians and libertarians, all have sufficient reasons to endorse both informed consent and the right of self-medication. From a consequentialist perspective, patients should be entrusted with making choices for themselves because they are generally most knowledgeable about (p.4) which decision will further their interests. From a rights-based perspective, medical decisions are often intimate and personal choices that are especially significant to patients. And even if a medical choice is not intimate, personal, or especially significant, people are more generally entitled to choose how they live their lives without being subjected to benevolent interference by physicians or public officials. Furthermore, even if people do not have general rights to make medical choices, it is wrong to force, coerce, or deceive people, and effectively constraining a person’s medical choices often requires force, coercion, or deception. These arguments in favor of patients’ rights to make medical decisions are often deployed on behalf of informed consent requirements, but they also justify rights of self-medication.

1.1 Two Motivating Cases

The following two cases illustrate the current state of medical paternalism:

Risky Refusal: Debbie has diabetes and her physician advises her to start insulin treatment. Debbie understands the risks of refusing insulin but is also unwilling to live by a schedule and monitor her medication. Against medical advice, Debbie decides to try to manage her diabetes with diet and exercise. Debbie’s physician is morally and legally prohibited from injecting Debbie with insulin against her wishes.

Risky Access: Danny has diabetes and his physician advises him to treat his condition with diet and exercise. Danny doesn’t want to invest the time or energy in diet and exercise and would prefer to just begin using insulin right off. Against medical advice, Danny wishes to try to manage his diabetes with insulin. However, Danny cannot legally access diabetes medication without a prescription from his physician.

Why is Debbie’s right to refuse treatment against medical advice legally protected and widely recognized while Danny’s right to make a similarly risky treatment decision is not? Many of the same considerations that justify Debbie’s refusal right also support Danny’s right to access treatment. For example, one justification for informed consent is that patients like Debbie know better than anyone else whether the risks of a particular treatment decision are justified given the potential benefits. But patients like Danny are also especially well placed to evaluate whether a risky treatment decision is justified. In addition, patients like Debbie and Danny both have rights to make intimate and personal decisions about their own bodies. If it is wrong for public officials or physicians to treat Debbie paternalistically, then it is wrong to paternalistically interfere (p.5) with Danny’s treatment decisions as well because the two cases are relevantly similar with respect to the moral considerations in favor of respecting Debbie’s choice.

One seeming dissimilarity between Debbie’s rights and Danny’s rights is that it would be morally worse for Debbie’s physician to forcibly inject her with insulin than it is for Danny to simply be barred from buying medication without a prescription. Yet informed consent protects patients from more than just forced treatment. It would be wrong for Debbie’s physician to deceive her or to trick her into consenting to treatment, or to pressure, threaten, or coerce her. Even if he doesn’t violently force her to use insulin, insofar as he deprives her of the ability to choose insulin he has violated her medical rights.

In Danny’s case, public officials prohibit him from accessing medication by using coercion. If Danny tries to use insulin, he could be forcibly prohibited from doing so or he could face criminal penalties, which are backed by force and threats of force. Even though few patients who seek access to pharmaceuticals directly encounter forceful interference by public officials, it is only because people preemptively comply with laws to avoid legal penalties, such as fines or prison sentences. If public officials legally prohibited patients like Debbie from refusing medical treatment, then patients’ consent would be invalid even if the prohibition were never enforced because everyone would comply with the law. So too, the mere threat of a legal penalty constrains patients like Danny’s ability to decide whether to use drugs, even if coercive penalties are rarely enforced because patients generally comply with the law.

For these reasons, a commitment to medical autonomy requires more than the protection of a person’s bodily integrity, which would prohibit forced treatment or battery. Deception and threats of force can invalidate medical consent too. And laws that prohibit people from accessing drugs are backed by threats of force, which are ultimately threats to a person’s bodily integrity. A physician can fail to obtain a patient’s consent even if he does not forcibly administer treatment or treat her when she is unconscious. If her treatment decision was a result of coercion or deception, then, even if she appears to consent, her consent is invalid. Similarly, public officials violate patients’ entitlements to make treatment decisions when they coercively enforce penalties for particular treatment choices.

1.2 Patients Know Best

In making the case for rights of self-medication for patients like Danny, I am assuming that rights of informed consent for Debbie are justified and that the rejection of paternalistic deception and coercion in the twentieth century is an example of moral progress in medicine. Of course, one may argue that neither (p.6) Debbie nor Danny should have the right to make inadvisable medical choices, but I regard this as too high a price to pay for rejecting self-medication since the reasons in favor of informed consent, which I will now review, are widely affirmed and independently compelling.

The first argument in favor of informed consent can be stated thus:

(P1) Each patient is typically in the best position to determine which treatments are in his or her overall interest.

(P2) Health workers should aim to promote patients’ overall well-being.

(P3) In general, the most reliable way to promote overall well-being is to defer to the expert.

(C) Health workers should defer to patients’ judgments about treatment options.

In other words, medicine should respect patients’ choices because doing so is the most reliable way to promote patients’ well-being on balance.

The first premise of this argument is meant to establish that each patient is generally in the best position to judge whether treatments are in his or her interest relative to other people who may decide. It is not meant to suggest that each patient is in an optimal position to make treatment decision or that people always will make the best decisions. Rather, people are generally sufficiently capable of judging what treatments are in their interest, and they have a presumptive advantage over other potential decision-makers. This premise originates with John Stuart Mill’s claim that no one but a person himself can judge whether a risk is worth taking because each person understands and cares about his own interests more than anyone else.⁵ Mill was not saying that patients are always the best judges of their own interests, but rather that they ought to be treated as if they were experts regarding their own interests because they have insight into their well-being and incentives to promote their well-being that everyone else necessarily lacks.

In the medical context, bioethicists, including Allen Buchanan and Robert Veatch, have affirmed the principle. Veatch writes, “There is no reason to believe that a physician or any other expert in only one component of well-being should be able to determine what constitutes the good for another being.”⁶ This principle (p.7) is compatible with various theories of well-being. Patients generally understand their own desires better than others; they know what causes pleasure or pain; and they know how they weigh their own values. In other words, doctors may be experts on health, but patients are the experts on themselves.

A person’s overall well-being is whatever is non-instrumentally good for her.⁷ Health is an important part of well-being according to most theories of well-being, but it is not the ultimate non-instrumental good for all people. For example, a hedonist may acknowledge that health is important for the experience of pleasure and that disease is bad because it often causes pain, but it needn’t always be so. Imagine a life-threatening hypothalamic brain tumor that causes euphoria. According to a hedonist, the tumor might promote well-being, at least in the short-term, but not health. The same can be said for other theories of well-being. People often desire good health but not to the exclusion of other goods. Health may be one good on an objective list of things that constitute well-being, but other things are also on the list.

The second premise also assumes that health is only one part of a patient’s overall well-being and states that health workers should aim to promote overall well-being. Better health does not guarantee a better life. We can imagine a person who pursues health to the exclusion of other values and has a worse life for it. And we can imagine someone who has a wonderful life despite the presence of a disease or disability.

A myopic focus on health mistakes the means to a good life for the good life itself, just like an obsession with money or admiration would. Health workers risk making a similar mistake if they focus too narrowly on patients’ health. Instead, they should keep in mind that the purpose of health is to facilitate a good life for the patient, not to make a patient’s body function as well as it can. This principle dates at least to Maimonides, who wrote that physicians should treat patients and not diseases.⁸ It’s easy for that message to get lost in an era of increasing specialization where physicians define themselves in terms of the kinds of diseases and conditions they treat. An orthopedic surgeon treats people who need new hips, not damaged femoral heads. Oncologists treat people with cancer, not tumors.

The third premise states that, in general, the best way to promote a person’s well-being is to defer to the expert, who is generally the person whose well-being is being considered. This claim is not committed to the view that judgments about well-being are subjective. Rather, even if we accepted an objective (p.8)theory of well-being (such as the view that well-being consists in an objective list of goods), it would still be true that people could generally assess their own well-being in terms of any theory of well-being better than other people could because a competent adult generally knows more about his or her life than others do.

There are also other moral reasons to defer to peoples’ judgments of their own well-being beyond the claim that people are generally the experts on what is good for them. When we defer to a person’s testimony about her experiences when deciding how to treat her, we are more likely to avoid practical problems of testimonial injustice—where a marginalized or eccentric person’s experiences are treated as less credible in virtue of unfamiliarity or systematic prejudices.⁹ If observers have reason to doubt a person’s testimony about her values and experiences, they may attempt to encourage reflection, to provide time or resources for disadvantaged groups to engage in meaningful deliberation, and to provide people with an opportunity to improve their critical thinking skills. But even in the absence of these measures, each person’s testimony should be treated with deference, even if her judgments about her well-being or values differ from expert or peer observers’ judgments.

Therefore, in light of patients’ epistemic advantage in knowing which medical options will promote their well-being on balance, physicians should defer to patients about treatment choices. One limit of this epistemic argument is that some theories of well-being state that what is non-instrumentally good for a person consists in what she would reflectively endorse if she were fully informed, or more informed, or more rational. But people’s reflective judgments about well-being (what they would judge as good for them with more information and better deliberative conditions) often depart from the judgments they act on or initially state about themselves.

And yet I am arguing that officials and physicians should defer to people’s stated judgments rather than the judgments they would hold on reflection. Though I would encourage people to reflect on their projects and ends and to think seriously about which choice would be best, there are three compelling reasons to reject the claim that people should only defer to a person’s reflective judgment about what is good for her. First, some people may reflectively judge that it is best if they do not overthink every choice. So while particular choices may not reflect their considered judgments, the choice to unreflectively make those choices does. In these cases, the epistemic argument for respecting a person’s autonomy would require respecting some unreflective choices, even if we hold that reflective judgments are the only ones that merit deference. Second, even if there are comparatively stronger reasons for people to act on (p.9) their reflective judgments (versus their stated judgments), there is no reason to think that those who paternalistically interfere generally interfere with stated judgments on the basis of what a person would reflectively endorse, or that their decision to interfere is not itself a rather unreflective choice. Third, those who are concerned that other people’s stated judgments differ from what they would judge on reflection may provide resources for further deliberation and offer information and advice to encourage reflective decision-making while also deferring to people’s stated judgments about well-being. So while we may grant that reflective judgments of well-being are more reliable or morally significant than stated judgments, this claim would not undermine the imperative to defer to people’s claims about their well-being.

To illustrate this epistemic argument for medical autonomy, imagine a deeply religious Jehovah’s Witness who believes that it is wrong to accept blood transfusions. While a physician might correctly judge that a blood transfusion is in the interest of her health, the physician might also agree that it is not in her interests all things considered, given her cultural identity and religious commitments. Or, we might imagine a cancer patient who refuses chemotherapy in an effort to preserve her fertility, even though alternative therapies are less likely to succeed than chemotherapy. Someone may forgo the best, most expensive daily medication in favor of a less effective but more affordable drug. A patient might refuse to schedule medically necessary treatment as soon as possible, so that she can participate in important life events such as her child’s wedding or a vacation with her spouse.

In all these cases, the doctrine of informed consent holds that the patient’s judgment about her overallinterests ought to prevail. It would be wrong for a physician to force or trick a Jehovah’s Witness into accepting a transfusion, to pressure a cancer patient into chemotherapy, to only provide an expensive treatment option when a less costly version is available, or to otherwise refuse to accommodate a patient’s preferences on the grounds that those preferences would undermine the patient’s health.

Beyond the doctrine of informed consent, other pervasive and widely accepted medical practices affirm this as well. For example, cosmetic surgery does not provide patients with any medical benefit, and it carries significant risks. But cosmetic surgeons act permissibly because their patients accept medical risks for the sake of non-medical benefits like larger breasts or a smaller nose. Similarly, physicians who treat athletes may facilitate treatment plans that are medically risky with the goal of helping their patients achieve athletic goals.

For example, cortisone injections reduce pain and inflammation so that athletes can play while injured. But the shots are not a substitute for physical therapy, for allowing time for an injury to heal, or for surgery. Cortisone shots can cause cartilage damage or ruptured tendons, and the long-term health effects are unknown. Despite the absence of a clear medical benefit and the presence (p.10) of significant risks, team doctors regularly administer injections to athletes so they can play. In these cases, physicians recognize that their duty is not to promote players’ health above all else because patients’ overall goals may necessitate endangering their health.

1.3 Patient Expertise and Drug Choice

This epistemic argument supports the doctrine of informed consent. It also explains why cosmetic surgeons can act permissibly even though they do not promote health. It explains why sports medicine can be an ethical industry. Additionally, this argument calls for the right of self-medication. Though proponents of an epistemic justification for the doctrine of informed consent often invoke Mill’s argument for a liberty principle, when Mill applied his argument to medicine, it was not in favor of a principle of informed consent but for rights of self-medication. Mill wrote that prescription requirements were wrong because they would interfere with patients’ choices and make some legitimate uses of drugs impossible, or at least more expensive.¹⁰

To extend on Mill’s argument, when it comes to a patient’s expertise about her own well-being, it doesn’t matter whether she is making a judgment about accessing or refusing treatment. When Debbie decides to refuse treatment, against medical advice, it is because she judges that treatment is not in her overall interest. When Danny seeks treatment against medical advice, it is because he judges that forgoing treatment is in his overall interest. In both cases, the reason to defer to Debbie or Danny is that Debbie and Danny are experts on their overall interests. In both cases their choice is against medical advice. If proponents of informed consent truly take a principle of deference seriously, then they should defer to patients, whatever their choice. This means allowing not only risky refusal but risky access as well, at least for similar levels of risk.

Again, this argument relies on the idea that health is only one of many values. Whether a particular treatment is safe depends on whether the overall risks of a drug are justified in light of the overall benefits. Drug safety is not a scientific judgment that requires medical training and expertise about the physiological effects of a chemical. Drug safety is a normative judgment that requires knowledge about how the risks and side effects of a drug fit into a patient’s life as a whole. Therefore, if the goal of pharmaceutical regulations were to ensure the safe use of medications, the epistemic argument would recommend that physicians and public officials defer to patients when it comes to drug choices (p.11)since patients are experts on themselves. The patient likely knows best how side effects will fit into her life as a whole, or whether she experiences her condition as severe and burdensome relative to the effects of a medication.

When a physician makes a decision about whether to allow a patient to access a prescription-only drug, the decision is based on an analysis of how risky the drug is, which depends on the severity of the condition it treats and the expected side effects for a particular patient-type. But a physician cannot know whether using a drug is “worth it,” which is precisely the question physicians are required to ask when they are designated as gatekeepers between patients and prescription drugs.

Pharmaceutical regulators are in an even worse position to judge whether a patient should have access to a drug. At least physicians meet the patients whose medication choices they have the power to constrain. Regulators make decisions for thousands of patients, whom they have never met, imposing the same risk-benefit calculus on a vast heterogeneous patient population. One patient may be extremely bothered by restless leg syndrome but tolerate dizziness with ease, whereas another may find that a side effect like dizziness is worse than a condition like restless leg syndrome. These patients will come to different judgments about whether taking a drug that is associated with dizziness to treat restless leg syndrome is worth it for them, but approval policies cannot capture these tradeoffs. It is impossible for a regulator to know whether the risks of a drug are acceptable in light of the potential benefits for each patient who is affected by the decision to prohibit a drug or limit access to an unapproved drug.

The distinction between what is medically advisable and what is a good choice is crucial to this argument. Even if it is medically inadvisable for a patient to use a dangerous, unknown, unapproved, untested drug, it may be advisable on balance. She may judge that the potential benefits will justify any health risk no matter how extreme. She may not care about a lack of information about a new drug. Some patients might seek dangerous and untested drugs out of desperation because no other treatments have worked and they suffer from terminal and degenerative illnesses. Proponents of drug regulations say that these patients decide against their interests when they seek ineffective drugs that have sickening effects. Yet even if it were true that allowing patients to choose medications would have negative health effects, healthcare professionals cannot know if allowing patients to choose medications would undermine patients’ overall well-being.

When pharmaceutical policy empowers physicians and regulators to decide whether the risks of a particular treatment are worth it given the benefits, people who have scientific knowledge are empowered to make decisions about other people’s values. Safety is a normative judgment. There is no pharmacological property of a substance or physiological property of a patient that a physician (p.12) or regulator can point to as the thing that makes it safe to use a drug. A drug is safe if the effects are not too severe in light of its benefits, but physicians and regulators are not trained to judge what makes a risk too severe. Nor should health workers be trained about what makes a drug acceptably risky or not, because the truth about acceptable risk will depend on each patient’s attitude, plans, and projects.

As a counterexample to the foregoing argument, we might imagine patients who genuinely do choose against their interests. Whether because of cognitive biases, stupidity, imprudence, or indifference, people make terrible choices all the time and later regret those choices. Yet for the epistemic arguments in favor of informed consent and self-medication to fail, it is not sufficient to simply point to examples where patients were mistaken about their interests. One would need to show instead that patients are more reliably mistaken about their interests than physicians and regulators.

Such an argument may go something like this.¹¹ Physicians and regulators are unbiased because they are not experiencing the pain and fear associated with an illness, and they also have much more experience seeing the effect of treatment choices not only on people’s health but also on their lives as a whole. In contrast, patients’ judgments are clouded by their emotions and limited experiences. Patients may also be unduly shortsighted and weak willed in circumstances where promoting long-term interests requires planning and distance from one’s immediate impulses. For example, a patient may acknowledge that losing weight is in her overall interest, but change her mind about those interests when she encounters a dessert tray.¹²

I will address this kind of skepticism about patients’ expertise throughout the following chapters, but for now I consider four responses. First, the price of this skepticism is to reject not only self-medication but also informed consent. If patients cannot make choices in their long-term interests, then as long as a deceptive or coercive intervention is not too burdensome, it shouldn’t matter if it limits access or refusal choices on behalf of the patient. Those who are skeptical of patients’ abilities to decide in their interests must either explain why it justifies limits on self-medication but not informed consent, or they must abandon informed consent as we generally understand it.

Second, even if patients suffer from reliable cognitive biases that impair their ability to perceive and act in their overall interests, physicians and regulators have cognitive deficits when it comes to perceiving another person’s interests. I claimed that patients are more motivated to promote their interests and more informed about their interests simply because those interests are their own. (p.13) Unlike most judgments, when it comes to judgments about oneself, partiality is a credential, not a bias.

Third, the claim that the relevant characterization of a person’s overall interests refers to her long-term well-being is itself a controversial claim. Some people may value their long-term well-being a lot, but others may embrace a carpe diem outlook that values the benefits of having dessert today more than any troubles a choice may cause in the future. Those who cite patients’ biases as a reason for skepticism about their qualifications to make medical choices must not only establish that patients are more biased than physicians but also defend the claim that certain ways of making decisions are biases—for example, deciding with a preference for the status quo or for short-term gains.

Fourth, even if patients’ judgments about their well-being are not reliable, it doesn’t follow that the judgments of physicians and regulators should prevail. Insofar as physicians and public officials can educate and inform patients in ways that ameliorate patients’ judgments, they ought to, since patients still have greater knowledge of their own values and experiences than others would even if they are biased or misinformed.

Another reason in favor of deferring to patients is that patients’ judgments about the effects of treatment choices can potentially become a self-fulfilling prophecy. The mere belief that a treatment will make a patient worse off could make it true that the treatment will make her worse off if she has it. Similarly, the belief that being denied a treatment would make a patient worse off may mean that denying treatment is harmful. Not only are patients generally experts on their interests, but also patients’ beliefs and choices determine what is in their interests. When it comes to a patient’s well-being, thinking that an intervention or prohibition is an injury might be sufficient to make it so.

This epistemic argument in favor of self-medication does not deny that medical experts are indeed experts on health and medicine. In most cases, an expert’s advice is relevant to a patient’s judgment about her overall interest. Many of us have a strong interest in preserving our health, so medical advice is tremendously valuable to us. Millions of people seek the advice of financial planners, consumer reports, and family therapists, even though citizens can legally manage their money, buy appliances, and navigate personal challenges without consultation or approval from an expert. Similarly, the freedom to choose which drugs to use would not undermine the importance or value of medical expertise. Anyone who values his or her health and is capable of accessing the advice of physicians, pharmacists, and regulators before using a risky drug is likely to seek out the relevant information.

However, prohibitive policies are not necessary for the provision of medical advice. The current system of pharmaceutical regulation doesn’t just encourage people to make medically advisable treatment choices; it requires them to do so. This policy is a mistake because not all patients will judge that acting in (p.14)accordance with medical advice is their best choice, and it is more likely that patients, rather than physicians, know which choices are in their interests. For this reason, where patients judge that their overall well-being departs from an expert’s judgment, public policy should permit patients’ judgments to prevail. This requires a right of self-medication—patients should be permitted to access their chosen treatment because they are best informed about their own values and interests.

1.4 Intimate Choices

If patients are generally the experts on their overall interests, then patients have a kind of epistemic authority that physicians and regulators lack. This is significant because many people think that medicine and government should promote overall well-being. Those concerned with overall well-being would then do well to consult the patients in matters of health. But even if I am wrong about patients’ expertise about their well-being, the strongest reasons in favor of informed consent and self-medication do not rely on epistemic considerations or empirical conjectures about which policies would promote well-being. The most important reason to respect a patient’s autonomy is that each person has the right to decide what happens to his or her own body.

Today, physicians and public officials must abide by the doctrine of informed consent, even when it is clear that a patient’s choice will not promote her overall well-being on any plausible account of well-being. Insofar as it is possible to knowingly make a choice that is worse for one’s well-being on balance, patients are entitled to do so when they make medical decisions.

Consider an analogy to romantic choices. Most of us can think of people in our lives who manage their romantic lives in ways that are terrible for their short-term and long-term well-being. This kind of a hopeless romantic might acknowledge this fact but, nevertheless, persist with her choices. She may not care about being happy, or having her desires satisfied, or living her life in a way that realizes an objective list of values. Or, she may care about those things but value other things more, such as her family’s approval or societal acceptance. Or perhaps she is very accepting of risk and judges that a slim chance of finding her soul mate is worth the distress caused by bad relationships. In any case, you might think that she is making a series of poor choices, and you might be right. But even if you were right, you still would not be entitled to trick or coerce her into dating your preferred matches, and you would not have a right to forbid her from dating people who were bad for her well-being. You could make recommendations, such as “maybe you should try dating women instead,” or “maybe you should stop dating your brother’s friends,” but enforcing these suggestions would be wrong even if doing so promoted her overall well-being.

(p.15) Medical decisions are similarly intimate and personal, if not more so. Medical choices are bodily, ailments and diseases are often impossible to ignore, and a person’s health has a substantial impact on every other choice and plan she makes. Anne Phillips argues that people are intrinsically embodied and that we cannot understand ourselves without reference to our bodies.¹³ Because of this link between persons and bodies, Phillips argues that bodily harms are more morally serious than other harms, such as property crimes. Even if embodiment is not intrinsically linked to one’s personhood and self-understanding, the fact that people attach special normative significance to their bodies is a reason to treat bodies as if they were morally distinctive.¹⁴ Another reason to grant special moral significance to bodily choices is that bodies are especially closely linked to a person’s autonomy. Most people require functioning bodies to carry out their plans and to write the story of their lives.

For these reasons, bodily choices have a distinctive quality that justifies distinctive protection for bodily rights. Patients are therefore justified in feeling violated when their physicians lie to them about the risks of treatment, just as it is a serious violation when people make other intimate choices under false pretenses.¹⁵ In Judge Cardozo’s ruling on Mary Schloendorff’s case, he emphasized that Mary’s rights to determine what should be done with her one body were sacrosanct. Other judicial affirmations of the doctrine of informed consent echoed this position. For example, in Cobbs v. Grant, the Supreme Court of California found that physicians must disclose the risks and benefits of alternative treatments on the grounds that “a person of adult years and in sound mind has the right, in the exercise of control over his own body, to determine whether or not to submit to lawful medical treatment.”¹⁶

Even if a physician never touches a patient’s body, if he fails to disclose relevant information about the patient’s treatment choices, he can violate the patient’s bodily rights. Philosophical justifications for informed consent also single out the particular importance of bodily choices. For example, Nir Eyal considers that a patient’s interest in personal integrity, especially bodily integrity, could ground informed consent requirements.¹⁷ There, he invokes Ronald (p.16) Dworkin’s idea of adopting “a prophylactic line that comes close to making the body inviolate.”¹⁸

Just as patients have rights to make decisions about medical interventions, such as surgery, and to be informed about the risks of each available treatment, patients also have rights to make decisions about medication in virtue of their bodily rights. For example, it would be a significant violation of Debbie’s bodily rights to trick or force her to use insulin. Yet, as in cases of informed consent and other intimate choices, the right to make decisions about medications not only prohibits unwanted interventions, it also prohibits people from concealing or prohibiting alternative choices. In this way, an official can therefore violate a person’s right, even if he never physically interferes with the person whose rights are violated.

To further illustrate this point, consider an analogy to reproductive choice. Proponents of abortion rights will sometimes make an argument that says, “my body, my choice.” By this they do not mean that their bodily rights entitle them only to refuse or consent to abortions when a physician or public official approves of that choice. Rather, “my body, my choice” is meant to imply that women are entitled both to choose to continue a pregnancy without interference and to access emergency contraception or abortion services from willing providers. The analogy to abortion is especially apt because it is another policy that reflects the misplaced sense of entitlement that public officials display when they legally limit what members of disadvantaged groups may do with their bodies, often in the guise of public health and safety. If women have rights to abortion, then laws that prohibit the provision of abortions violate women’s abortion rights, even if women never face legal penalties for abortion and criminal sanctions only apply to providers.

An analogy to the right to die is also helpful on this point. In 1997, John Rawls, T. M. Scanlon, Thomas Nagel, Ronald Dworkin, Robert Nozick, and Judith Thomson jointly penned “The Philosophers’ Brief,” an amicus curiae brief for two Supreme Court cases arguing for a constitutionally protected right to die. In it, they argued that the Constitution ought to protect patients’ right to die because the interest in making end-of-life decisions “is so central a part of the more general right to make ‘intimate and personal choices’ for himself that a failure to protect that particular interest would undermine the general right altogether.”¹⁹ The right to refuse lifesaving treatment was already protected as part of informed consent, but the philosophers in “The (p.17) Philosophers’ Brief” pointed out that the right to access deadly treatment was justified for the same reasons.

Both abortion and assisted dying are exceptionally personal decisions. In these cases the right to refuse treatment is not enough to respect a person’s singular entitlement to terminate a pregnancy or end his or her life. For patients to truly have meaningful options when it comes to abortion or assisted dying, the right to use medical services or drugs is necessary as well. More generally, the examples of assisted dying and abortion illustrate how the decision to use a particular drug could be the kind of intimate choice that merits protection, since pharmaceuticals can be used to cause an abortion or to end a person’s life.

But abortifacients and deadly drugs are not the only pharmaceuticals that might be required for a patient to live and die in accordance with her most deeply felt commitments. Similarly, choices about using or not using pharmaceuticals can be important for the expression of a person’s identity or integral to a person’s ability to live in accordance with her values. For example, some religions discourage people from taking psychotherapeutic drugs, and their members define themselves in terms of this choice. But other people may find that they cannot achieve their goals or act in accordance with their values without the assistance of psychotherapeutic drugs. For both groups, decisions about pharmaceutical use are intensely personal choices. Contraceptives are another class of drugs that are closely linked to people’s interest in bodily integrity. Some women choose not to use contraception while others value the ability to have sex without getting pregnant or benefit from contraceptives in other ways. In this case, access to pharmaceuticals is necessary for women to effectively control their own bodies.

Dietary choices also helpfully illustrate the connection between self-medication and the right to decide what happens to one’s body. Diabetic patients like Debbie and Danny are entitled to make risky food choices, even if doing so threatens their overall well-being. The risks of choosing unhealthy food can be as substantial as the risks of choosing to use a drug against medical advice. Millions of people suffer from conditions related to obesity that threaten their long-term health. Yet people are nevertheless entitled to eat unhealthily, and patients like Debbie are entitled to opt for a healthy diet instead of using pharmaceuticals. Why are people entitled to ingest unhealthy food in dangerous quantities but not comparably permitted to take dangerous drugs? This asymmetry cannot be sustained. If the freedom to make dietary choices is justified because food is an especially significant expression of a person’s identity, or an important part of daily life, or an exercise of one’s bodily rights, then it shouldn’t matter whether someone is swallowing a pill or a piece of pie.

(p.18) 1.5 Anti-paternalism and Freedom to Choose

One may resist this line of argument by claiming that the fact that people tend to value intimate and personal bodily choices more than other choices does not mean that those choices merit special protection. This argument could go two ways. On one hand, perhaps resistance to violations of bodily integrity is mere squeamishness and taboo, and people shouldn’t think their bodily choices are different from choices that affect their property or their reputations. But this view would seem to license a range of interventions that are deeply at odds with liberal values and foundational ethical commitments such as the doctrine of informed consent.

On the other hand, if people were unjustified in singling out bodily choices, then perhaps other sorts of entitlements, such as property rights or reputations, would merit further protection as well. Such a view would preserve the conviction that patients’ rights of informed consent or self-medication merit protection even if intimate and personal decisions were not morally uniquely important. Instead, the duty to respect patients’ autonomy would be justified by an appeal to the more general principle that all choices that patients value merit protection, whether they involve bodies or not.

This strategy highlights another justification for rights of self-medication that doesn’t rely on the aforementioned arguments about the importance of medical autonomy. Even if one rejects the claim that people have specific rights of self-medication, it would not follow that public officials are entitled to use coercion or force to prevent people from making treatment decisions, because people do have more general rights against coercion and violence. So even if a person’s treatment choice does not concern matters that are particularly intimate or personal, public officials should refrain from using coercion to limit his choices as long as he does not choose to violate other people’s rights.

This idea, which is most firmly grounded in Kantian principles, is affirmed by a range of philosophical perspectives. One reason to endorse a presumption of respect for people’s choices is that we are rationally required to acknowledge the value of our own and others’ choice-making capacities, as Kant and contemporary Kantians have argued. On this view, a person would be inconsistent if he acted as if his plans and projects had authority in determining how he lived his life but did not recognize the authority of other people’s plans and intentions in determining how they lived their lives.

Other normative ethicists arrive at similar conclusions. Stephen Darwall persuasively argues that paternalistically interfering with a competent adult’s choices reflects a failure to recognize the respect that she is owed as a member (p.19) of the moral community who has equal status to others. In other words, paternalism is incompatible with an assumption of moral equality. Darwall writes:

The objectionable character of paternalism … is not primarily that those who seek to benefit us against our wishes are likely to be wrong about what really benefits us. It is not simply misdirected care or even negligently misdirected care. It is, rather, primarily a failure of respect, a failure to recognize the authority that persons have to demand, within certain limits, that they be allowed to make their own choices for themselves.²⁰

According to these views, even if interference would benefit a person, it is still wrong to paternalistically interfere with a choice because it is disrespectful to the authority she has to make her own choices.

Similarly, egalitarians may agree that paternalistic interference is generally impermissible on the grounds that it expresses an infantilizing or offensive judgment of a person. As Jonathan Quong argues, paternalistic interference is pro tanto wrong because it is motivated by a negative and offensive judgment about another person’s ability to choose well.²¹ Paternalism is therefore incompatible with an assumption that all members of society are morally equal and entitled to equal freedoms. Seana Shiffrin similarly argues that paternalism always calls for further justification. Shiffrin writes:

[Paternalism] directly expresses insufficient respect for the underlying valuable capacities, powers, and entitlements of the autonomous agent. Those who value equality and autonomy have special reasons to resist paternalism toward competent adults.²²

These arguments do not entail that paternalism can never be justified, but they do set a high standard for proponents of paternalism to justify interfering with people’s choices for the sake of their own well-being. On these accounts, any justification of paternalism must not only establish that the paternalism is effective (thereby overcoming the epistemic challenges to paternalism described in the previous sections) but also explain why the moral reasons against violating a person’s rights and expressing an offensive view of her capacities are outweighed by the moral importance of forcing her to make the “right choice.”

(p.20) A presumption in favor of free choice is also justified by an appeal to the interests that everyone has in virtue of being autonomous beings. For example, Ryan Davis has argued that because autonomy is a future-oriented capacity, every autonomous person has an interest in effectively making decisions and plans, which requires that people refrain from interfering with other people’s plans.²³ Similarly, Christine Korsgaard offers an interpretation of Kant’s Formula of Humanity that shows how we can deduce substantive moral principles, such as the duty to refrain from paternalistic interference, by reflecting on what it is to act.²⁴ She argues that we should think of moral reasons as the objective reasons we have, whatever our inclinations or desires (in contrast to the subjective reasons we have only in virtue of our desires).²⁵ She then makes the case that people have objective reasons to respect other people’s choices because the only thing that each person has reason to value is the capacity to value, which is same capacity as the capacity to choose. Crucially, well-being is not unconditionally valuable for people in this universal way because the choices that promote one person’s well-being will not promote another’s.²⁶ In contrast, each person does have an unconditional reason to respect other people’s choices because, once you recognize the value of your own ability to choose, “you must view anyone who has the power of rational choice as having, in virtue of that power, a value conferring status.”²⁷ In practice then, Kant’s argument requires that each person refrain from interfering with other people’s choices, but people are not required to attend to conditionally valuable features of others, such as features of their well-being. Therefore paternalistic interference is impermissible because it involves interference with a person’s ability to choose for the sake of her well-being.

All these arguments against paternalism share in the conviction that respect sets the limits on what is permissible. Contrast these views with what is sometimes called a consequentialism of rights.²⁸ A consequentialist might hold that we should promote autonomous choosing rather than respect autonomous choices. If so, then interference with autonomous choices would be justified in those cases where it promoted autonomy on balance. For example, a consequentialist might argue that it is permissible to interfere with a person’s decision to drink if being drunk would undermine her autonomy on balance. The foregoing arguments in favor of freedom of choice are different from a consequentialism of rights because (p.21) they maintain that, even if interference would promote autonomy, it is still impermissible because it would violate the authority each person has to make her own choices.

There are other egalitarian reasons to oppose paternalistic interference by public officials too. Paternalism has long been used to justify violating the rights of vulnerable and oppressed groups. During the nineteenth century, American slavery apologists disingenuously justified slavery by an appeal to paternalism.²⁹ Women were historically denied economic liberties and political rights on the grounds that men could better secure women’s interests. Even today, workers are prohibited from taking jobs that public officials deem degrading or dangerous, such as jobs as sex workers or jobs that violate maximum hour requirements. These considerations highlight the disproportionate harms of paternalistic policies. Furthermore, rich, well-connected, and socially advantaged people are able to avoid or pay the penalties associated with prohibitive policies, including paternalistic ones. Paternalism further subjects marginalized people to governmental interference without their consent, ostensibly for their own sake.

These arguments against paternalism support rights against self-medication insofar as prohibitive pharmaceutical policies are justified by an appeal to the interests or well-being of people who would access pharmaceuticals in the absence of restrictions. In light of these considerations, anti-paternalism is particularly important in medical contexts because patients are especially vulnerable. Like people who endure racism, patriarchy, and poverty, those who suffer from a disability or an illness are often marginalized, discriminated against, and disadvantaged. But a person’s marginalized status does not justify treating her like a child, which only compounds the harms of marginalization. Paternalism toward children is only justified insofar as they lack the capacity to decide. Unlike children, adults who face oppression or misfortune are not rendered incapable simply because they cannot effectively overcome social or natural adversity.

Ultimately, I think the most compelling reasons for rights of self-medication are these more general reasons against paternalism. Patients not only have epistemic authority about their interests and well-being, they also have the normative authority to make treatment choices. Policies that prohibit people from accessing pharmaceuticals are disrespectful. They express a judgment by physicians and policymakers that people are not able to competently make a pharmaceutical choice and, like other forms of paternalism, treat adult patients as if they were children. The doctrine of informed consent is supported by each of these arguments against paternalism. Physicians cannot interfere with a patient’s choice in order to benefit her because to do so is to violate her right to (p.22) decide for herself, and it expresses the judgment that the physician has more of a claim to choose what happens to her body than she does.

1.6 Patient Protection

Another reason to support the doctrine of informed consent is that it protects patients from abuse. In particular, even if one is unconvinced by arguments in favor of a general right to choose, one may agree that people have rights against coercion, battery, or fraud. Medicine involves interactions between physicians and patients that would be impermissible without consent, which transforms actions that would ordinarily be immoral (e.g., cutting into someone’s body) into something permissible.

This justification for informed consent is based on Manson and O’Neill’s argument that the doctrine is best understood as a way of preventing physicians from acting wrongly.³⁰ On their account, informed consent is a way of ensuring that all physicians take due care to ensure that their patients are sufficiently informed so as not to be deceived and to protect patients from feeling coerced or pressured to make a particular decision. They therefore think of informed consent as a way of knowing whether a patient has waived her rights—the right to not be deceived or rights against battery, for example.

To see why this argument for informed consent also justifies a right of self-medication, it is helpful to focus on the insight that informed consent transforms what would otherwise be an impermissible violation into permissible conduct by a physician. For example, performing unwanted medical interventions is a form of battery, but providing a surgery to a consenting patient is permissible and even praiseworthy in most cases. As Manson and O’Neill discuss at length, withholding information and deceiving a patient is wrong, but if physicians have a conversation with patients and allow opportunities to ask questions and learn about a treatment, the patient cannot claim to have been misled or wronged. Finally, it would be abusive for physicians to threaten patients with penalties if they did not comply with medical advice, and it is difficult to see how informed consent requirements could permit this kind of behavior, so informed consent prohibits coercion by medical professionals.

Now consider whether pharmaceutical regulations constitute behaviors that would be abusive in other contexts, and whether patients have an opportunity to transform what would otherwise be mistreatment into something permissible by way of their consent. Pharmaceutical regulations are backed by threats of legal force, such as fines and, in some cases, criminal penalties. In ordinary circumstances, if a public official or a physician threatens to physically restrain (p.23) a patient, take her money, or imprison her for making an unhealthy decision; such conduct would be a kind of mistreatment unless the patient consented. That is, if it is wrong to coerce a patient so that she makes an advisable medical choice, then it shouldn’t matter whether the coercion is done by a physician or by a public official.

Patients do not consent to the pharmaceutical regulations that are enforced by physicians, pharmacists, and public officials.³¹ Therefore, just as informed consent requirements stand as a check against coercive treatments, informed consent should also stand as a check against the coercive practices of public officials, such as pharmaceutical regulations that deprive patients of their rights of self-medication.

1.7 Ignorance and Fraud

The idea that consent can alter the moral landscape between a patient and her provider is also helpful for understanding why the doctrine of informed consent and rights of self-medication include rights against being deceived about the known and unknown risks of drugs. However, not all instances of ignorance amount to deception, so not all forms of patient ignorance invalidate a patients’ ability to consent to pharmaceutical use or refusal.

One source of patient ignorance is the inherent risks associated with many pharmaceuticals, which pose unknown dangers to those who use them. But in general, if a person can consent to an outcome, then she can also consent to the risks of that outcome. So if a person was entitled to take a drug that was guaranteed to have a particular effect (e.g., a deadly drug or a drug that only caused stomach cramps), then she is also able to consent to use a drug that carries a risk of that effect. Another source of patient ignorance is the cost of learning about a drug. But a reasonable person may choose to remain somewhat ignorant about the risks of a (p.24) drug if she judges that the risks of remaining ignorant are justified in light of what she does know and the costs of learning more. In these cases, the mere presence of risk and uncertainty do not invalidate a patient’s ability to consent to treatment.

There are three reasons to accept the principle that if a person can consent to drugs with certain outcomes that she can also consent to drugs that carry known and unknown risks. First, drugs with certain outcomes may be understood as drugs that have a 100 percent likelihood of a particular effect. It is unclear why a person would be permitted to consent to a 100 percent likelihood of a single outcome but not a 50-50 lottery between two outcomes. Second, the decision to forgo pharmaceutical use is also risky, so if the mere presence of risk overturned a person’s ability to consent to pharmaceutical use, it would also threaten rights of informed consent. Third, imagine a person created a drug that had completely unknown risks and effects, such that it could cause death or immortality, pain or euphoria, disfigurement or incredible beauty, personality change and memory loss or perfect rationality and memory.³² Further imagine that the likelihood of all these outcomes is also completely unknown. If the manufacturer of such a drug accurately represented the thoroughly mysterious nature of the drug, people could consent to use it. This example may seem far-fetched, but it reflects the idea that the first humans to use a newly developed drug after animal testing are in similar circumstances, yet few question their ability to consent to participate in early trials because the uncertain nature of the drugs are disclosed to them. But if a person can consent to a drug about which nothing is known, then, more generally, patients can consent to use drugs about which little is known.

On the other hand, patients who consent to take a drug do not necessarily automatically consent to all the risks associated with taking a drug. Voluntary assumption of a known risk does not amount to consent to the effects of the risk when the risk in question is associated with another person’s wrongdoing.³³ After all, if a woman walks through a dangerous neighborhood on her way to work, she voluntarily walks on the street, where she may accidently step on some glass or trip on the sidewalk, but she does not consent to be robbed.³⁴ Similarly, when people consent to use drugs, they can consent to the disclosed risks of the drug, such as potential side effects. But people cannot consent to be deceived by manufacturers about the nature of a product.³⁵

(p.25) Consent is a way of waiving one’s general entitlement against interference, thereby altering the moral landscape between people. Deception is a form of interference that people cannot waive their entitlements against. If a person knew she was waiving her rights to be deceived, then deception would not be effective. Deception undermines a person’s ability to consent to treatment in the same way that force or coercion does; by denying her the power to authorize treatment. If a physician or provider deceives a patient about a treatment, the patient cannot consent because she is unaware of what she is actually consenting to.

Both the epistemic and rights-based justifications for informed consent and rights of self-medication require protections against deception. Consider the epistemic argument first. A person is only in the best position to judge whether one treatment is better than another if she capable of learning about both treatments and of understanding the limits of her knowledge. Deception about drugs interferes with a patient’s ability to know the truth about her treatment options. So a deceived patient’s treatment choices may not reliably reflect her judgments about whether a treatment will promote her well-being on balance. In contrast, if truthful information about a drug is available to a patient and she chooses not to read it, then she consents to remain ignorant about the nature of a drug, and so we may assume that she judges that she would be better off on balance if she made an uninformed choice, perhaps because she judges that consulting an expert or learning about a new treatment is more costly in expectation than uninformed self-medication.

The deontological case against deception is more familiar. Following Kant, philosophers who defend people’s rights against interference also tend to defend rights against deception. For example, Christine Korsgaard argues that lying is wrong because it is wrong to control another person’s will. Since people cannot consent to be deceived, all acts of deception are a kind of interference with a person’s natural authority to govern her own life.³⁶ By its very nature, the purpose of deception is to prevent one from acting as she would if she knew the truth. Alternatively, Tamar Schapiro argues that moral norms like honesty presuppose a reciprocal moral relationship between equals.³⁷ Paternalistic deception, and deception in general, violates these norms because it deprives only those who are deceived from having genuine control over their lives. People continue to discuss which background conditions mark out some locutions as deceptive and others as merely manipulative or misleading, and whether strategic reticence can ever amount to wrongful deception. But these debates about the scope of (p.26) wrongful deception do not undermine the more foundational claim that deception is wrong because it violates people’s general rights to autonomously set and pursue their ends and to be treated as moral equals.

For these reasons, just as the doctrine of informed consent forbids physicians from knowingly withholding a cancer diagnosis or exaggerating the risks of a procedure, rights of self-medication forbid manufacturers from knowingly withholding information about the risks of a drug or from misleading patients about the risk of a treatment. In both cases, manufacturers are not entitled to deceive patients about the nature of a treatment, and public officials may rightly prevent and punish deception and fraud. Public officials may permissibly penalize fraud preemptively or in the event of harm, because, at either point, deceptive manufacturers are liable to be interfered with on the grounds that they are wrongfully deceiving consumers.

One may object to the claim that it is wrong for manufacturers to knowingly withhold information about the risks of their products. For example, James Child argues that an appeal to bodily rights (which he calls self-ownership) cannot on its own justify fraud protections, since such a view would seem to imply that a person’s bodily rights can be violated by silence alone and this claim is in tension with the idea that each person is entitled (in virtue of his bodily rights) to simply remain silent and to refuse to provide others with information.³⁸ This point requires further clarification. If a manufacturer admits they are not disclosing all information about a product, or if norms develop where people assume that manufacturers withhold information about their products, then it may not be wrong for manufacturers to intentionally withhold information because patients would be able to knowingly consent to the risks of using drugs that potentially carry unknown risks. But if a manufacturer leads patients to believe they are disclosing all relevant information about a product and there are norms in place where people expect that manufactures disclose the contents and known information about their products unless stated otherwise, then it could be deceptive for manufacturers to knowingly withhold information about the risks of their products.

1.8 Self-Medication and Unapproved Drugs

Rights of self-medication require changes to the approval process for investigational drugs and changes to the prescription drug system. In the rest of this chapter, I will preview the arguments in favor of these policy reforms, which I will further defend in the next three chapters. For now, I will highlight the ways (p.27) that the foregoing arguments in favor of self-medication apply to these two policies in particular.

Consider first the approval process. Currently, patients are legally prohibited from accessing investigational drugs until they have been approved safe and effective by regulators at government agencies such as the FDA or the European Medicine Agency (EMA). Yet safety is a normative judgment. Officials may certify a drug as safe even if there are some risks associated with its use, on the grounds that the benefits outweigh the risks. Given that officials tolerate some level of risk regarding drugs, the question is then how much risk is acceptable given the benefits of a drug. This is a question that can be answered only by an appeal to normative considerations, such as considerations about the value of a drug’s benefits or the value of avoiding side effects and risks, and considerations about how best to make trade-offs between quality of life and life expectancy. Just as physicians are not well placed to judge whether a course of treatment is justified given her patients’ other normative commitments, public officials are not well placed to judge whether using an investigational drug is acceptably safe for a large and heterogeneous patient population whose values and circumstances differ.

Premarket testing requirements that prohibit patients from accessing investigational therapies also violate patients’ rights to make intimate and personal decisions. The decision to use a drug in order to die is the kind of intimate and personal decision that shapes the narrative of a person’s life in a significant way. And the decision to use a drug in order to live, which patients with terminal and degenerative illnesses make when they seek access to investigational drugs, is similarly as intimate and personal. In both cases, a person is choosing how he or she wants to live and die, and, in both cases, access to drugs that are currently prohibited is required. Insofar as a drug could save a patient from death or degenerative illness, self-medication rights are also a species of more general rights of self-preservation.

More generally, prohibitions of experimental drugs are paternalistic, and they interfere with patients’ ability to access potentially therapeutic drugs. Physicians and manufacturers are not legally permitted to provide patients with unapproved drugs unless they are given special permission to do so through compassionate access programs. This means that if a patient wishes to purchase and use an unapproved therapy, even if her physician agrees that doing so will improve her health and promote her overall well-being, she may be legally prohibited from doing so on the grounds that accessing unapproved drugs is dangerous. Laws that prohibit patients from accessing unapproved drugs and physicians from using them are also coercive. Patients who aim to exercise their rights of self-preservation or their bodily rights by using unapproved drugs face threats of fines and other legal sanctions.

(p.28) One concern is that approval requirements are necessary to ensure informed consent because otherwise patients and physicians would not have enough information to know whether a drug was safe or effective. Yet the off-label drug market in the United States demonstrates that a market in unapproved drugs is not incompatible with informed consent. In the United States, drugs are tested as effective treatments for particular patient-types with specific conditions. Once approved, those drugs can be prescribed off-label for any condition. Off-label prescribing gives us a glimpse into a world without prohibitive testing requirements. Without FDA approval for efficacy, physicians and patients rely on the available scientific evidence and decide whether the risks of an off-label treatment are justified. Off-label prescribing is common for children and pregnant patients, and most chemotherapy treatments are an off-label combination of drugs. The pervasiveness and success of the off-label market suggests that premarket efficacy testing requirements are not necessary to protect patients.

Patients’ rights advocates have long argued for a right to try certain drugs, at least for people with serious and treatment-resistant conditions. The patients’ rights movement has won significant victories in speeding the pace of approval and expanding access programs for investigational drugs. For example, more than twenty US states recently passed “right to try” legislation, which allows physicians and manufacturers to provide patients with access to investigational drugs outside the context of a clinical trial. Nevertheless, most patients still lack access to most investigational drugs, and the approval system remains prohibitive in all developed countries. Self-medication requires a right to try for all patients and citizens.

1.9 Self-Medication and Prescription Drugs

In addition to reforming the approval process, physicians and public officials should also rethink the prescription drug system in light of patients’ rights of self-medication. Like premarket approval requirements, the prescription drug system violates rights of self-medication because it empowers physicians and regulators to prohibit patients from making treatment decisions. Prescription systems vary by country. Some places allow more drugs over the counter than others, and many European countries offer a third option of “behind the counter” drugs that do not require a prescription but do require authorization from a pharmacist. But all developed countries enforce prescription requirements for some drugs, such as painkillers.

Epistemic arguments in favor of self-medication support reforms to current prescription drug systems because the current systems all privilege physicians’ and pharmacists’ judgments about treatments, instead of patients’ judgments about whether using a drug is the right choice. The example of Debbie and (p.29) Danny illustrated that this asymmetry is unjustified. In general, patients are more likely to be right about whether a treatment choice will promote their overall well-being. Patients are experts on their values and tolerance for risk, and choosing against medical advice should not undermine our belief that a patient is better equipped to decide what is best for her life on balance than her physician. Moreover, whether a patient chooses to refuse or access a treatment against medical advice does not undermine her epistemic advantage in knowing whether her treatment choice is in her interests.

To further illustrate this point, consider people who access neuroenhancing drugs, such as Adderall, without prescriptions. A growing number of students and professionals use neuroenhancements even though they do not have a medical condition that warrants the prescription of the drugs. Under the current system, people without a diagnosis of attention deficit disorder (ADD), or a similar condition, cannot legally buy Adderall because they cannot obtain a physician’s prescription for the drug. One justification for a prohibition of Adderall is that the drugs are not safe enough to be used as neuroenhancements because they have significant health risks, such as high blood pressure, cardiovascular problems, anxiety, mania, and insomnia. Despite these significant risks, physicians are not equipped to judge whether the risks of Adderall are justified for the sake of the cognitive benefits it brings. Rather, some people with ADD may judge that the risks of using Adderall are not worth it despite the benefits, even if a physician recommends prescription treatment to manage the symptoms of ADD. And some people who do not suffer from ADD may judge that the risks of using Adderall are acceptable given the cognitive benefits of using the drug.

The example of Adderall also illustrates how the prescription drug system limits patients’ rights to make intimate and personal decisions, and how the system is paternalistic and coercive. If a person goes on a diet to fit in a wedding dress, or enrolls in an extreme running program to complete a marathon, she may incur significant health risks because of her dietary or fitness choices, but she is permitted to do so on the grounds that she can make risky bodily choices for the sake of other values. People can permissibly use alcohol to make going to a club more enjoyable even though alcohol can be dangerous. Students are not forbidden from pulling all-nighters to gain an advantage on an exam, even though sleep deprivation is unhealthy. Similarly, a person who uses a neuroenhancing drug may accept the risks of drug use to make studying more enjoyable or to gain a professional advantage. The rights to incur bodily risks for the sake of important projects is a species of the more general right to decide what happens with one’s own body, which is justified on the grounds that bodies are subjectively and objectively very important to people and that bodies are crucial for people to live their lives in accordance with their own values.

(p.30) Prescription requirements are also paternalistic and coercive. Paternalism is wrong because it interferes with each person’s natural entitlement to make self-regarding choices, and, in most cases, prescription drug requirements interfere with this entitlement by limiting the range of drugs a person can use. Paternalistic interference also expresses a negative and offensive judgment that a person is not equally entitled to make a decision as whoever is interfering. Prescription requirements express the judgment that patients are not entitled to make drug choices about their own bodies; they send the message that physicians and regulators have some authority to make pharmaceutical choices for other people.

Prescription requirements also coercively violate patients’ rights of self-medication by using threats of legal penalty and state-sanctioned force to prevent people from exercising their normative authority to use pharmaceuticals without authorization. Returning to the example of Adderall, the US Drug Enforcement Agency (DEA) classifies Adderall as a Schedule II drug, meaning that only licensed practitioners can provide them to people and that patients must be authorized by a licensed practitioner to use them. Unauthorized possession or distribution of a Schedule II drug is punishable by up to five years in prison. Even if some prescription requirements are justified on the grounds that some drugs are addictive, which is an argument that I will address in the third chapter, officials’ interference with non-addictive pharmaceutical choices could not be justified on these grounds.

1.10 Conclusion

Though different, the epistemic and rights-based justifications for informed consent agree that a patient has a special normative relationship to her own life. The epistemic justification focuses on a patient’s authority in knowing what will promote her overall well-being, whereas rights-based justifications focus on a patient’s authority in deciding what to do. The rights-based argument provides a less conditional foundation for rights of self-medication, whereas the epistemic justification for self-medication is more empirically contingent, especially for theories of well-being that do not give special weight to choice or desire-satisfaction.

In most cases though, both arguments deny the claim that physicians and public officials have the authority to either substitute their judgment for a patient or to decide on a patient’s behalf. So the doctrine of informed consent and rights of self-medication are both supported by moral considerations that relate to the value of autonomy and the moral significance of well-being.

(p.31) The same considerations that support the doctrine of informed consent support rights of self-medication because a person does not forfeit her moral status and authority to consent when she steps outside the clinic and into the pharmacy. Patients have superior knowledge about themselves and their own well-being, whether they are deciding to use or to refuse treatment. So proponents of informed consent should reaffirm their commitment to patients’ rights by also advocating for self-medication. This may strike some as a revisionary conclusion, but the recognition of informed consent requirements in the twentieth century also faced significant opposition from members of the medical profession before they were widely affirmed. The current system of barriers and regulations is an injustice just as other forms of medical paternalism were unjust in the past. If we are to continue the moral progress that began in Mary Schloendorff’s era, we should take patients’ rights seriously for all kinds of medical choices, including pharmaceutical use.