The Politics of Self-Medication Jessica Flanigan “Hey, Hey FDA—how many people did you kill today?”

The Politics of Self-Medication

Jessica Flanigan

DOI:10.1093/oso/9780190684549.003.0005

Abstract and Keywords

Patients can advocate for rights of self-medication in several ways. First, patients should be included in the process of drug development and should not be prohibited from developing and testing treatments on their own or privately funding medical research. Second, patients can use social media to advocate for access to new drugs and drug approval. Third, patients have a moral right to engage in civil disobedience and to illegally access and distribute pharmaceuticals. Fourth, citizens should support large-scale patient activism, such as the ACT UP and right to try movement. Fifth, officials should advocate for political reforms to protect patients’ rights of self-medication, even if such reforms lack democratic support.

Keywords:   patient advocacy, civil disobedience, Plan B, medical marijuana, AIDS activism, right to try

On October 11, 1988, more than one thousand protesters gathered outside the headquarters of the FDA to protest the FDA’s slow approval process and failure to support the development of AIDS treatments. They stopped traffic and blocked entrances. Some protestors held signs saying things like “RIP—Killed by the FDA” and chanted “Hey, Hey FDA—how many people did you kill today?” At least 120 protesters were arrested by police officers who wore surgical gloves and helmets.¹ An organization called AIDS Coalition to Unleash Power (ACT UP) organized the protest, as well as several other activist campaigns on behalf of AIDS patients and AIDS awareness. According to Gregg Bordowitz, who was one of the principal organizers of the FDA protest, the goal of the protests was to “cut through the bureaucratic red tape” of the FDA and also to ensure that people with AIDS were involved in decision-making about research related to treatment and cures.

The ACT UP protests were exceptional in their scope and influence, but political opposition to limits on self-medication is not uncommon. At every stage of drug development, patients and their advocates have asserted their rights of self-medication in institutional contexts that limit medical autonomy. During the early stages of drug development, citizen scientists not only participate in early stage research by funding studies and shaping the design and goals of experiments, but also, in some cases, play a role in developing and testing new treatments. During later stages of development, patients and their families use social media to support calls for compassionate access. As trials continue, patient groups protest and petition for accelerated approval and expanded access to drugs that treat specific conditions, such as muscular dystrophy or ALS (amoyotrophic lateral sclerosis).

(p.143) When drugs are not approved, patients and their physicians may engage in civil disobedience. For example, advocates of self-medication have disobeyed laws that prohibit assisted suicide or medical marijuana on the grounds that such prohibitive policies were illegitimate. Patient activism and protest also draws attention to the deaths caused by prohibitive regulations. For example, right to try activists have successfully convinced twenty-four state legislatures in the United States to adopt legislation that would facilitate terminally ill patients’ access to unapproved experimental drugs.

In this chapter, I discuss the ethics of patient activism and the political changes that a right of self-medication would require. My argument follows the trajectory of a drug’s development. I begin by discussing the ethics of patient-driven drug development. I argue that patients should be included in the drug development process and that they should not be prohibited from developing and testing treatments on their own as well. I also make the case that privately funded medical research by patients and foundations is no more fraught than research funded by universities and governments. Second, I discuss justifications of other forms of patient activism during the approval process, such as social media campaigns for compassionate access and political advocacy for drug approval. Though the language of compassionate access suggests that regulators are benevolent when they grant patients the right to use unapproved therapies, I argue that those who request compassionate access should be seen as victims of political oppression because the state threatens their lives.

Since existing pharmaceutical policies are seriously unjust, I argue in the third section that civil disobedience and illegal distribution of pharmaceuticals is justified. I then present several reasons that those who disobey pharmaceutical policies should not be required to publically disobey for the purpose of drawing attention to an unjust law. Rather, secret disobedience and disobedience that is not politically motivated is morally permissible. Fourth, I consider larger scale efforts at patient activism, such as the ACT UP and right to try movements, and I argue that citizens have duties to support these efforts or at least to not oppose them. Finally, I consider the kinds of political reforms that would be necessary to protect rights of self-medication. I argue that political reforms should proceed by way of constitutional change and judicial bodies should protect rights of self-medication. Limits on self-medication developed through popular calls for greater regulation, but these democratic sentiments are influenced by unjustified cognitive biases, and they support policies that violate people’s rights. For these reasons, voters do not have the authority to pass laws that limit self-medication and constitutional measures are preferable to democratic or legislative initiatives.

(p.144) 5.1 Patient-Driven Development

The phrase “nothing about us without us” is popular within the disability rights movement.² It is meant to convey the idea that disabled people should be included when medical professionals and public officials make decisions that affect their lives. The same can be said of all people, but especially for patients who are suffering from diseases that pharmaceutical researchers aim to treat. Since patients have rights to pursue treatment options, including access to unapproved drugs, participating in the process of drug development is one way for patients to assert these rights even before a specific treatment exists.

In recent years, patients have claimed a greater role in drug development and treatment within the pharmaceutical industry and throughout the regulatory process. For example, the FDA recently introduced a new initiative for patient-focused drug development, which aims to include patients’ perspectives in pharmaceutical research at every stage.³ Patients will have an opportunity to provide information about their experiences that inform researchers’ and regulators’ assessments of risks and benefits. Or patients can help researchers develop more efficient ways of communicating about new drugs. And patient-focused development may also empower patients to influence researchers’ priorities and the goals of treatment development. Patient-focused drug development is currently limited to meetings with a narrow set of patient populations, but the initiative represents a shift to greater inclusion of patients in pharmaceutical development.⁴

Other forms of patient-driven drug development occur outside of formal research settings and regulatory institutions. Patients fund trials, develop and test pharmaceutical and alternative therapies, and form communities of citizen-scientists that share research and experiences in order to provide better treatment for people within their disease communities. Citizen-science movements are found within rare disease communities where there is little institutional or industry support for research and among large patient populations whose collective voices can be particularly influential. Some companies have recently facilitated greater patient involvement in the development process as well.

The first way that patients can play a greater role in development is by financing trials or paying to participate in trials. Amy Marcus calls these practices “venture philanthropy,” which refers to a system where patients can provide support (p.145) for early stage research and therefore shift attention to questions that concern their own patient community.⁵ In some cases, venture philanthropy can not only finance effective treatments but also generate revenue for future research. For example, the Cystic Fibrosis Foundation recently received a $3.3 billion payout, which was a financial return for its early investment in a drug that was subsequently approved by the FDA as a treatment for the lung disease.⁶ Critics alleged that the Cystic Fibrosis Foundation should not have been in a position to profit from the high price of treatment because it would conflict with their interest in advocating low drug prices for people with cystic fibrosis. Yet others reply that it is good that some of the profits from new treatments go toward further improving cystic fibrosis patients’ lives and funding new research, which would not be guaranteed if all profits went to a pharmaceutical company.⁷

Alexander Masters describes another model of patient-funded development where clinical trials are funded in part by patients who purchase the chance to receive a potentially effective treatment.⁸ As a preliminary test of this system, he describes a new trial, which will allow people who wish to purchase a place in a glioblastoma trial to pay $2 million to secure a spot if they meet the inclusion criteria.⁹ As long as the inclusion of wealthy patients does not disadvantage people who cannot pay or hurt their chances of participating in a trial, Masters argues that allowing patients to secure their place in a trial could be a viable way to finance medical research. Of course, such a system would only work if patients were prohibited from purchasing unapproved therapies directly. But in light of prohibitive approval policies, Masters’s financing model allows more patients to effectively exercise their rights of self-medication by using unapproved drugs.

Another form of patient-driven drug development is more direct. In some cases, patients or their family members may develop and test therapies on themselves, and share their results and experiences with people who suffer from the same diseases. As an example of this approach, consider Chris and Hugh Hempel’s efforts to develop an experimental treatment for their twin daughters, Addi and Cassi. The Hempel twins suffer from Niemann-Pick Type C (NPC), which is a rare and fatal progressive disease that causes degeneration of the nervous system and dementia.¹⁰ Most children with NPC require extensive care (p.146) as they lose the ability to eat, walk, and talk, then die before reaching adulthood. The disease is generally resistant to treatment, but when Chris Hempel’s daughters were diagnosed with NPC, she researched all potential therapies, including animal studies of NPC. She eventually discovered very limited evidence that cyclodextrin, a sugary substance used to dissolve other drugs, extended the lives of mice with NPC. Hempel ordered powdered cyclodextrin and tested the substance on herself for a few weeks before giving it to her twin daughters. Hempel then petitioned the FDA for access to intravenous cyclodextrin and was granted permission for a physician to administer it to the twins. Though it was not a miracle cure, the twins improved after using the drug, and it seemed to slow the progression of their disease. Chris Hempel then shared her experiences with the drug and organized other parents whose children were using experimental cyclodextrin to collect patient data, as the National Institutes of Health (NIH) ran a parallel trial on other children with NPC.

If Chris Hempel had not started the drug development process on her own, cyclodextrin research for children with NPC may never have progressed. NPC is a rare disease, and there are limited resources for research that addresses it. Nevertheless, some parents of children with NPC questioned the Hempels’ decision to give their daughters cyclodextrin because it had not been tested or approved as a treatment for NPC and was potentially more risky than allowing the disease to progress.¹¹ Cassi suffered a blood clot related to the catheter she used to receive cyclodextrin that paralyzed the left side of her body. Subsequent research found that cyclodextrin infusion could cause NPC patients to become deaf, though it may also extend their lives.¹² And for children with NPC, rights of self-medication cannot justify the risks because the children cannot give informed consent to treatment. On the other hand, parents and physicians may reasonably judge that “home remedies” give their children the best chance at managing a rare or terminal illness. Medical professionals agreed with the Hempels that cyclodextrin was a promising treatment and supported their treatment plan.

For adult patients, the case for DIY drug development is even stronger, because patient-driven development may uncover promising new treatment possibilities, but, even if it didn’t, adult patients are entitled to make their own treatment decisions and exercise their rights of self-medication. Those who claim that drug development outside institutional or regulatory contexts should be discouraged on the grounds that patients are not qualified to develop drugs without any professional or regulatory oversight must also question whether (p.147) patients are qualified to refuse treatment without professional or regulatory oversight. If so, then the same considerations justify these forms of patient-driven drug development.

Patients may also facilitate pharmaceutical development through communities of citizen-scientists. Consider the story of David deBronkart, who was one of the earlier “e-patients” to advocate patient empowerment through online networks. When deBronkart was diagnosed with stage IV renal-cell carcinoma, he joined an online community of cancer patients where he learned about new treatments that were relatively unknown.¹³ DeBronkart attributes his survival partly to the treatment information and support he found in his online community. While physicians and researchers still play an important role, deBronkart argues that other patients know things that are relevant to treatment decisions that medical professionals are unlikely to know, such as new therapies, and things that they cannot know, such as the experience of treatment and potential side effects.

DeBronkart’s experience is just one example of a more general phenomenon, where patients are using online networks to gain access to drugs that are newly approved or still in development. Amid calls for greater access to medical research, open data and open science, patients can increasingly play a role not only in choosing treatments but also in developing new ones. Eric Topol also describes how patients can use online communities to influence drug development. For example, ALS patients used publically available information and their own data to test an unapproved therapy:

Studying [Phase 1 studies] enabled one patient with ALS to conclude that the active drug in one of these early Phase 1 studies was sodium chlorite. Affected patients began treating themselves with this chemical, which is obtained by bleaching paper pulp. Collectively, via the social online health network PatientsLikeMe, a rapid crowdsourced clinical trial took form, albeit without controls. … [The trial showed] no sign of efficacy. In fact, taking sodium chlorite was associated with an adverse effect. Using clever algorithms, PatientsLikeMe can simulate a randomized trial within their database and had already demonstrated that another candidate drug for ALS, lithium bicarbonate was ineffective using this method. That finding was subsequently validated by a traditional, expensive, and time consuming randomized trial.¹⁴

(p.148) Topol writes that pharmaceutical companies also use online networks to recruit patients for clinical trials, which could further improve patients’ access to unapproved medications.

New businesses and nonprofits have recently emerged to further facilitate this patient-driven approach. MyTomorrows is a patient platform that helps patients find drugs that are in development, navigate early access provisions and clinical trials, and manage regulatory systems across borders. Patients do not pay for these services. Instead, drug developers pay MyTomorrows drug royalties or a commission for connecting patients with development-stage treatments. Sage Bionetworks is a nonprofit that advocates open science as a way of facilitating drug discovery. In 2013 Stephen Friend announced that Sage was developing a cloud-based platform to encourage patients to share their medical data and experiences as a way of including patients in drug development while also facilitating better drug development.¹⁵ In 2015, Sage opened enrollment for two studies as part of this initiative—a Parkinson’s study that uses data from mobile apps to study the factors that influence fluctuations in neuromotor development, and a breast cancer survivor study that explores the long-term effects of chemotherapy and the efficacy of behavioral and environmental modifications as a way of managing these effects.¹⁶

These forms of patient-driven drug development are an example of one of the ways that patients can assert their medical autonomy and rights of self-medication. New technology is empowering people in need to access information, treatment, and support like never before. And just as importantly, these technological innovations are making the political ideal of “nothing about us without us” a real possibility. As with other political movements, as patients gain the capacity to inform themselves and form organized communities, they also gain the ability to resist the traditional, paternalistic norms that have governed medicine for so long.

Patient-driven drug development is also a political act insofar as it challenges existing approval policies by empowering patients to take their medical decisions into their own hands. The medical progress that has been made by patient developers and communities of citizen-scientists also further undermines claims that rights of self-medication for people with terminal and degenerative illnesses are infeasible because patients are incapable of understanding complex medical information and making such serious treatment decisions. Not (p.149) only can citizen scientists access and interpret evidence that informs their own treatment decisions, their expert knowledge is also increasingly driving drug development for everyone.

5.2 Disobedience and Distribution

To legally use an unapproved therapy, patients must enlist manufacturers and physicians to assist them as they navigate either a clinical trial or an expanded access program. In some cases, neither of these efforts is successful, and patients cannot access an unapproved therapy. In these circumstances patients historically acted outside the law when regulations gave them few other options. The citizen-scientist movement was initially formed in the 1980s and 1990s at the start of the AIDS epidemic. At the time, scientists did not know a lot about AIDS, there were few available therapies, and patients died quickly after being diagnosed. When experimental drugs and off-label therapies were suggested as potential treatments, patients formed buyers’ clubs that imported and distributed unapproved therapies to members.¹⁷ At the time, critics worried that buyers’ clubs would harm patients, undermine the testing process, and threaten approval for promising drugs. But people with AIDS had few other options. They could not legally access unapproved therapies, and all approved therapies were ineffective.

In this section, I argue that citizens may permissibly disobey pharmaceutical regulations and drug laws. Especially in the circumstances that AIDS patients faced in the 1980s, illegally importing and distributing pharmaceuticals to willing consumers is not only permissible, it is also praiseworthy. Many discussions of the ethics of disobedience focus on civil disobedience, which is disobedience for the sake of a political cause. Philosophers sometimes argue that disobedience is only justified if lawbreakers act publically, so that their conduct calls attention to injustice, and accept punishment for breaking the law.¹⁸ Yet, in some circumstances, civil disobedience is not justified, such as when lawbreakers wrongfully violate a just law. And in other cases, disobedience that does not qualify as civil disobedience is justified, such as when people secretly resist an unjust law to benefit the victims of injustice. So while civil disobedience is distinctive in that it is a form of protest, whereas other acts of disobedience are not, whether an act of disobedience is political does not settle questions about its permissibility. First, I will address the permissibility of disobedience in general. Then, in the (p.150) next section, I will turn to civil disobedience, which I think is closer to freedom of expression or protest because of the normative issues it raises.

Buyers clubs for AIDS patients were politically motivated in a sense. Certainly the members were politically minded and disapproved of the FDA’s policies. But their primary purpose was to distribute drugs to AIDS patients. Other examples of unauthorized self-medication or facilitating other people’s self-medication when it is against the law illustrate that disobeying drug laws can take many forms. For example, when patients import drugs from other countries to obtain unauthorized drugs, to use drugs without a prescription, or to pay lower prices, they disobey pharmaceutical policy for non-political reasons. Patients who fail to comply with quotas or monitoring of prescription painkillers disobey too. Patients who use medical marijuana in places where it is illegal and those who form medical marijuana buyers’ clubs disobey too. Recreational drug users and dealers also disobey drug policy to exercise their rights of self-medication or to facilitate self-medication by others. Whether these forms of disobedience are permissible will depend on whether the laws they break are just laws, and if not just, whether citizens have obligations to obey laws that are unjust. In previous chapters, I argued that laws that prohibit self-medication are unjust laws. I will now argue that citizens do not have obligations to obey them.

My view is that citizens do not have duties to obey unjust laws that violate people’s rights.¹⁹ Public officials are entitled to enforce laws that protect people’s enforceable rights. But officials may not permissibly coerce or force citizens to comply with laws when citizens lack sufficient moral reasons to obey and may have strong moral reasons to disobey. The mere presence of a legal prohibition is not sufficient to establish that citizens have a duty to obey a law that constrains their choices. Officials must also be morally entitled to enforce the law, for example on the grounds that citizens would lack the moral authority to make those choices in the absence of legal prohibition.

For those who share this view, the conclusion that citizens may permissibly exercise their rights of self-medication even when it is illegal will follow from the preceding argument that limits on self-medication are unjust. But many philosophers do not share this view of obligation and may be unconvinced by my claim that rights of self-medication are generally so strong. For example, many people think that if a state is sufficiently just or legitimate, then citizens can have duties to obey some unjust laws. Yet even those who endorse theories of political obligation think that the duty to obey the law is only a pro tantoobligation, (p.151) meaning that it can be outweighed if there are stronger moral considerations in favor of breaking it. For example, if obeying an unjust law requires a citizen to violate another person’s fundamental rights, such as rights of self-preservation or bodily rights, then the citizen’s general duty to obey would be outweighed by the duty to respect people’s rights. So even according to this view, disobedience would be permissible when public officials enforced policies that violated rights to make medical decisions or rights of self-preservation. But those who hold this view might reject the claim that disobedience is permissible when officials prohibit recreational drug use.

Others may argue that disobedience is only justified if obeying an unjust law would have terrible consequences—if it caused unnecessary death and suffering for example. According to this view, the pro tanto duty to obey the law and the duty to respect rights of self-medication could both be outweighed by a more general duty to avoid bad consequences. For consequentialists, both obligations (to obey law and respect rights of self-medication) would be justified by an appeal to the well-being they promote.²⁰ Yet on this view, it would be permissible to violate prohibitive pharmaceutical policies whenever violating disobedience would have good consequences. Therefore, even if there were a pro tanto obligation to obey the law because obedience generally had good consequences, such an obligation would be outweighed whenever disobeying pharmaceutical regulations to promote well-being on balance would have good consequences.

For other prominent theories of political obligation, the considerations that people generally cite in favor of a duty to obey the law cannot justify a duty to obey unjust pharmaceutical regulations that violate patients’ rights.²¹ For example, Richard Dagger argues that citizens have duties of fair play to obey laws.²²On this account, because citizens benefit from the overall legal system, they must bear the burdens of complying with the particular law that they do not support. Yet at least for those patients whose fundamental rights of self-preservation are violated by prohibitive drug policies, the overall legal system does not benefit them on balance because the legal system deprives them of the means to save their own lives. At least for these patients, duties of fair play do not generate any obligation to comply with pharmaceutical policies.

Democratic theories of political obligation also do not support the claim that citizens are obligated to comply with all pharmaceutical regulations. For (p.152) example, Thomas Christiano argues that people have a duty to obey the law because those laws were a result of fair democratic procedures.²³ Say we grant for the sake of argument that laws that are democratically passed could generate a moral duty for citizens to obey them. Democratically passed laws would presumably have authority because they derive from each person’s equal authority to participate in government. In other words, such a duty to obey would be grounded in people’s pre-political rights, which would explain why even those who believe that people have duties to obey democratically passed laws deny the claim that people must obey laws that violate the fundamental non-political rights of minorities. But pharmaceutical restrictions violate the fundamental rights of minorities, for example, sick or disabled people, so the claim that citizens have obligations to comply with pharmaceutical regulations in virtue of their role as citizens would not succeed because prohibitive regulations violate the very rights that generally justify participatory rights.

Others argue that people have duties to obey laws in virtue of their associative obligations to fellow citizens. For example, Samuel Scheffler argues that people who are in non-instrumentally valuable relationships can have special obligations to one another even if they did not consent to the obligations, just as people have general moral obligations, even if they do not consent to them.²⁴ John Horton develops similar arguments in favor of political obligation.²⁵ These arguments for political obligation draw analogies between citizenship and other relationships that seemingly generate obligations without consent, such as friendship or family relationships.²⁶ But if these relationships can generate duties between citizens, they would most plausibly generate a duty to assist citizens who are threatened by unjust pharmaceutical regulations. Generally, special obligations are cited as reasons in favor of providing people with assistance, not as license to violate their rights.

Proponents of these arguments on behalf of a duty to obey the law also agree that such duties are infeasible, so even if they did justify a general duty to obey the law, just as obligations between friends can be outweighed by our general moral obligations, compatriot obligations could be outweighed too. And those who argue for associative duties also deny that they generate obligations when a relationship is not valuable, such as friendships that are premised on abuse or (p.153) injustice. So as above, for these reasons, even if people did have duties to obey laws in virtue of the political relationship, they would not be morally required to comply with harmful pharmaceutical regulations that treat patients and consumers unjustly.

Another theory of political obligation appeals to the idea of natural rights. Rawls, for example, argued that citizens are obligated to obey the law because the law protects their natural rights.²⁷ Relatedly, Anna Stilz argues that people have duties to obey the law because the law is a necessary condition for the protection of people’s freedom from interference.²⁸ But since pharmaceutical regulations violate people’s fundamental non-political rights, such as bodily rights and rights of self-medication, self-preservation, and the rights to die, democratic and natural rights theories of political obligation do not support a duty to obey pharmaceutical regulations. And the same response is apt regarding Christopher Wellman’s argument that people have duties to obey the law because they have Samaritan duties to provide assistance, and supporting the law is one way of satisfying these duties.²⁹ Even if this argument were successful, in cases where laws are harmful and policies prevent people from providing assistance, as is the case for many pharmaceutical regulations, then the Samaritan duties that Wellman cites as a general reason to obey would not only permit but also require that people disobey pharmaceutical policies.³⁰

Like Wellman, George Klosko argues that people have duties to contribute to systems that provide people with presumptively beneficial goods.³¹ But Klosko clarifies that these duties apply particularly to goods that are non-excludable, such as clean air or national defense.³² And pharmaceutical regulation is not presumptively beneficial, and it is excludable since knowledge about drugs and certification could theoretically be given to those who pay for it and not to others. Klosko also caveats his argument for political obligation by noting that citizens do not have duties to comply with legal systems that disproportionately benefit some groups more than others, even if all citizens benefit from the system (p.154) on balance. Pharmaceutical regulations excessively burden sick people who are denied access to beneficial drugs. So on this view, even if citizens benefit from the information provided by regulatory agencies, they are not obligated to obey the overall system of pharmaceutical regulations, even if such an argument could justify political obligation in other cases.

This overview of theories of political obligation is meant to show one doesn’t need to be an anarchist to think that citizens do not have duties to comply with pharmaceutical regulations. In general, arguments for the claim that there is a duty to obey the law focus on duties to comply with redistributive property rules or to support policies that are not otherwise required by moral obligations. However, most people who support a duty to obey the law would deny the claim that it can generate a duty to obey an unjust law that violates people’s most fundamental rights, so political obligations are limited. Many theories of political obligation are justified by an appeal to fundamental rights or a general duty to promote well-being, and in these cases the very reasons that are cited in favor of political obligations can also be cited in favor of disobeying some pharmaceutical regulations. Therefore, even if people did have duties to obey the law, the most prominent justifications for such duties would not support duties to obey pharmaceutical regulations.

5.3 Civil Disobedience

Some forms of disobedience go beyond lawbreaking for the sake of self-medication and also function as acts of protest against policies that prohibit self-medication. Civil disobedience is a form of political expression where a citizen breaks an unjust law in order to draw attention to the injustice of the law. Patients and their advocates can violate pharmaceutical regulations in this way when they publically assert the right to die or when they grow and distribute medical marijuana. We can imagine other forms of civil disobedience on behalf of rights of self-medication as well, such physicians publically providing patients with unauthorized or unapproved drugs.

In this section I will develop a qualified defense of civil disobedience and lawbreaking for the sake of rights of self-medication. Since I have argued that patients are not obligated to obey pharmaceutical regulations that violate rights of self-medication anyhow, their conduct needn’t meet the usual criteria for civil disobedience to be permissible. And there are also good reasons for patients and their advocates to refrain from characterizing their decision to violate pharmaceutical regulations as civil disobedience since publically violating such laws for political reasons and submitting to punishment could in some cases undermine the cause of self-medication rather than drawing attention to the injustices of pharmaceutical regulations.

(p.155) Consider two forms of civil disobedience currently practiced by advocates of self-medication. First, in 1998 Dr. Jack Kevorkian famously assisted in the voluntary euthanasia of Thomas Youk on national television. Youk suffered from ALS and consented to euthanasia. He and Kevorkian chose to televise the procedure as a way of drawing attention to the injustice of laws that prohibit euthanasia. Kevorkian was then convicted of second-degree murder and served eight years in prison. In Australia, Dr. Philip Nitschke and Dr. Fiona Stewart distribute information about how to illegally obtain drugs for the purpose of euthanasia. In The Peaceful Pill Handbook, Nitschke and Stewart describe a group of elderly patients who illegally manufactured deadly barbiturates as an act of mass civil disobedience against the prohibition of voluntary euthanasia.

Second, some citizens engage in civil disobedience in protest of medical marijuana policy too. For example, in 1998 Cheryl Miller suffered from multiple sclerosis, and illegal medical marijuana effectively treated her symptoms. As a medical marijuana advocate, she used marijuana in a congressman’s office to protest federal marijuana regulations. Gustin Reichbach was a judge who wrote a letter to the New York Times in 2012 describing his medical marijuana use in an effort to give voice to the concerns of other patients who were unable to publically protest prohibitions. Reichbach wrote:

This is not a law-and-order issue; it is a medical and a human rights issue. … Doctors cannot be expected to do what the law prohibits, even when they know it is in the best interests of their patients. When palliative care is understood as a fundamental human and medical right, marijuana for medical use should be beyond controversy. … Because criminalizing an effective medical technique affects the fair administration of justice, I feel obliged to speak out as both a judge and a cancer patient suffering with a fatal disease.³³

In 2016, Allen Peake, a Georgia state representative, committed civil disobedience by publically defending his decision to transport medical marijuana from Colorado, which permits marijuana use, to patients in Georgia, where medical marijuana is prohibited. Peake told a reporter, “I made a commitment to these families when I got involved. … If it involved civil disobedience, it’s been absolutely worth it.”³⁴

(p.156) The examples of voluntary euthanasia advocacy and medical marijuana protests show that civil disobedience can be an effective way to draw attention to unjust policies that violate patients’ rights of self-medication. And since it is permissible to disobey pharmaceutical regulations that prohibit self-medication for non-political reasons, it is also permissible to violate them as a form of political protest. On the other hand, patients and their advocates are not obligated to publically disobey pharmaceutical regulations to draw attention to the law, and, in some cases, there are good reasons to disobey secretly, for non-political purposes and to attempt to evade punishment.

One good reason to secretly disobey pharmaceutical regulations is if the purpose of disobedience is to provide treatment to someone in need. So while Rep. Peake publically admitted to bringing marijuana from Colorado to Georgia, he did not disclose the identities of the families he was assisting because doing so could have endangered them. Typically, people who use pharmaceuticals without authorization intend primarily to treat their symptoms and not make a political point. In these cases publicity for the sake of rights to self-medication could undermine people’s exercise of their rights of self-medication.

Public disobedience can also harm other patients. For example, it is currently extremely difficult to legally access unapproved therapies outside the context of an expanded use program, and manufacturers are sometimes reluctant to provide therapies outside the context of a trial because they are concerned that adverse reactions would expose them to liability and public backlash. Adverse reactions are also more likely for patients who suffer from terminal and degenerative conditions because those patients are already in poor health and typically take many other drugs, even though they are the patients who stand to benefit most from new therapies. So if a patient were able to access an unapproved drug (which is unlikely) and she experienced an adverse reaction, then she could potentially undermine the prospects of approval for a drug, cause manufacturers to halt a trial, and harm other patients who would potentially benefit from approval. This concern is not unfounded. In 2014 the FDA halted a clinical trial of the cancer drug CytRx after a patient who was using the drug through an expanded use program died.³⁵

Or if physicians publically disobeyed pharmaceutical regulations, they could lose their prescribing power, which would thereby undermine their ability to facilitate informed self-medication long-term. Similarly, cannabis buyers’ clubs and dispensaries that operate in violation of federal law may reasonably operate in secrecy because otherwise they would be punished for providing valuable (p.157) services to patients in need.³⁶ Health workers should not concern themselves with drawing attention to the injustice of approval policies when they encounter dying patients and judge that the best way to remedy the injustices that individual patients face is to secretly provide unapproved drugs. Their first priority physicians should be helping their patients in ways that do not set back the potential for other patients to benefit from a drug.

Disobedience also need not be motivated by conscientious reasons. Though people who illegally facilitate access to pharmaceuticals often are altruistically motivated, they are not motivated by the conviction that pharmaceutical regulations are unjust. For example, some physicians who illegally distribute opioids to patients sincerely believe they are helping their patients. Stephen Schneider is a physician who is currently in prison for unlawful distribution of controlled substances:

He almost always took his patients’ side when they complained about doctors who had “discriminated” against them for needing opioids. Schneider [said], “I don’t even know the actual quote for the Hippocratic Oath, but aren’t you doing harm if there’s a treatment for something and you refuse to use it?”³⁷

Schneider argued that no one else in his community was willing to provide healthcare to low-income patients who suffered from chronic pain. He believed he was doing the right thing, even though many of his patients used opioids in ways that were not medically indicated. Though Schneider did not disobey opioid policy for political reasons, he was still motivated to disobey.

Even purely self-interested motives would not render disobedience impermissible. Health workers who illegally sold unapproved drugs to AIDS buyers’ clubs or Canadian pharmacists who ship low-cost pharmaceuticals to patients in the United States may be motivated by the desire to profit. But they still do more for patients in need than an altruistic health worker who refuses to take professional risks for the sake of her patients. The intention behind disobedience does not bear on its permissibility.³⁸

(p.158) Physicians like Stephen Schneider and those who violate approval requirements also should not be expected to submit to punishment because it is not morally wrong to provide pharmaceuticals to informed and consenting patients. The main justification for a requirement that lawbreakers submit to punishment is the idea that lawbreakers should acknowledge the overall legitimacy of the state when drawing attention to an unjust law. But even if states were legitimate on balance, it would still be wrong for states to punish those who are not liable to be punished. Since people who illegally provide and use pharmaceuticals act permissibly, they are not liable, so the state would act wrongly by punishing them.

So when Don and Iris Flounders engaged in civil disobedience by speaking publicly about their decision to obtain deadly amounts of Nembutal from Mexico, they were not under a duty to submit to punishment for illegally importing deadly drugs. Don Flounders was therefore justified in hiding the drugs from the Australian government, who raided the Flounders’ home after they publicized their choice. As Don commented in a video that he recorded before his death, “luckily I’d hidden the drugs well … there’s a lot of rabbit burrows down here at Warragul [Austrailia].” If Don and Iris had not tried to evade punishment for importing illegal drugs, the Australian government would have frustrated the couple’s efforts to choose the time and manner of their deaths. If the Flounders complied with the law they would have implicitly validated the state’s authority to enforce laws that violate patients’ rights and cause needless suffering. Patients like Don and Iris are under no obligation to acknowledge the legitimacy of unjust laws that violate their rights, even if their governments were more broadly legitimate.

At this point a caveat is in order. These arguments are not meant to suggest that all acts of legal disobedience are justified when it comes to pharmaceuticals. In particular, the wrongfulness of prescription and approval requirements would not necessarily permit stealing drugs from pharmacies and manufacturers. This is more than a theoretical concern since hundreds of pharmacies are robbed every year in America alone. Yet pharmacy robberies not only consist in disobeying approval and prescription requirements (which I have argued are illegitimate laws), they also violate people’s property rights and often involve threats of violence against pharmacy employees. In most cases at least, pharmacy employees do not forfeit their rights against violence by participating in the prescription drug system. Whether non-violent pharmaceutical theft is morally wrong would depend on more general questions about the justice of the property system, especially in light of the urgent needs of others. Assuming (p.159) that manufacturers and pharmacists have legitimate property rights over pharmaceuticals, then pharmacy robberies are unlikely to qualify as permissible disobedience.

5.4 Protest and Activism

The tension between disobeying in order to exercise one’s rights and disobeying in order to draw attention to rights violations is not unique to rights of self-medication. Henry David Thoreau secretly harbored slaves in violation of the Fugitive Slave Act, and by concealing his actions, he was able to help more people than he would have if he had publically harbored slaves.³⁹ Fredrick Douglass also opposed public disobedience on the grounds that it would make slave owners more watchful, and therefore more effective at continuing to enslave people.⁴⁰ So while secret disobedience is sometimes criticized on the grounds that it prevents other citizens from judging whether disobedience is permissible, when the public is blind to the injustice of the current system, disobedience may not be the best way to draw attention to injustice.

This is not to suggest that people should not advocate rights of self-medication in other ways. As Thomas Hill argues, everyone who is a bystander to an unjust law has a duty to oppose or resist it.⁴¹ The paradigmatic examples of bystanders to injustice are ordinary Germans during World War II who did not support or oppose Nazism and southerners who recognized the injustice of Jim Crow and segregation but did not do anything to change it. Some scholars have argued that the criminalization of recreational drugs is akin to these policies because the drug war is instrumental to the oppression of black Americans. Insofar as the drug war is the new Jim Crow, ordinary Americans remain bystanders to oppression if they do not resist unjust drug policy. And as I have argued, prohibitive pharmaceutical regulations are a form of oppression too. Patients are vulnerable groups. People who are sick have a difficult time asserting their rights. Patients are politically and economically disenfranchised, and the patient rights movement is spread thin across many disease-specific advocacy groups. Yet patients’ rights are a species of human rights. People are entitled to make decisions about (p.160) their own bodies. Policies that violate patients’ rights of self-medication are therefore oppressive policies that mistreat vulnerable groups.

The primary agents of injustice, such as the public officials who enforce prohibitive drug regulations, are the most morally culpable for oppressive policies. But all citizens in states that enforce unjust pharmaceutical laws have duties to critically examine current laws and to ask themselves whether they are justified in remaining passive. Hill argues that each citizen should cultivate a character that enables him or her to resist an unjust law if given the chance. By tolerating injustice, people contribute to the ongoing oppression of patients through negligence. Even if bystanders to oppressive drug regulations do not intend to violate patients’ rights, even if they are ignorant of the harm that is caused by the policies, and even if they are basically good people who want to help patients, all citizens who accept unjust pharmaceutical policies are involved in a system of oppression in some way. Those who are more closely involved in patient care, such as manufacturers and physicians, are more culpable for their complicity in these injustices. Hill writes:

Bystanders … can be enablers of oppression in ways that amount to complicity. They may be regarded as oppressing or adding to the oppression of the victims through their omissions and passivity.⁴²

Citizens should therefore consider how they could oppose and resist policies that violate patients’ rights of self-medication, even if it requires them to take some professional risks or to bear some personal sacrifices.

Advocates of self-medication have historically approached the cause in three ways—protest, direct advocacy, and political lobbying. In addition to the ACT UP protests of the 1980s, patient groups have organized rallies and protests outside the offices of public officials and regulatory agencies in order to get better access to drugs that treat ALS, and obtain emergency contraception, medical marijuana, and cancer treatments.⁴³ On the other hand, people have (p.161) also protested policies that gave people more access to pharmaceuticals, such as approval of opioid painkillers and Truvada for pre-exposure prophylaxis.⁴⁴Though both forms of protest should be protected as acts of political speech, only the protests in favor of self-medication are praiseworthy because they are advocating for more just pharmaceutical policies.

Another way to advocate for rights of self-medication is through direct advocacy, such as social media campaigns on behalf of patients who seek access to potentially lifesaving therapeutics. For example, when a pediatric patient named Josh Hardy suffered from a life-threatening adenovirus infection in 2014, his physicians at St. Jude Hospital were initially denied access to Brincidofovir, an experimental drug that was being tested as a treatment for a different virus in immunocompromised adults. Even though Brincidofovir showed promise as a treatment for adenovirus as well, the manufacturer, Chimerix, was initially reluctant to provide the drug presumably out of concerns that it could potentially harm Josh and undermine the drug’s chances of approval. Josh’s family then launched an extensive social media campaign on Hardy’s behalf, which compelled Chimerix to establish a new clinical trial for adenovirus that included Hardy as the first patient.⁴⁵ Hardy recovered from the infection. Hardy’s story is just one among an increasing number of accounts of patients who use social media to directly advocate greater access to pharmaceuticals.⁴⁶

Citizens may also advocate rights of self-medication through political speech such as lobbying. For example, the Goldwater Institute has followed ACT UP’s lead in framing self-medication as a political cause.⁴⁷ Whereas ACT UP focused on access to AIDS treatment, the Goldwater Institute advocates for right to try policies that would give patients with treatment-resistant degenerative and terminal diseases earlier access to unapproved drugs. The Abigail Alliance also advocates for better access to experimental drugs. Drug policy reform groups such as NORML and the Drug Policy Alliance and Students for a Sensible Drug Policy and Americans for Safe Access also advocate the decriminalization of recreational drugs and the legalization of medical marijuana. Non-governmental organizations such as the World Health Organization, International Red Cross, (p.162) and the UN Commission on Drugs and Crime also advocate the decriminalization of recreational drugs.

These organizations develop legislation, publicize research about the harmful effects of policies that violate patients’ rights of self-medication, and organize citizens to lobby public officials on behalf of patients and consumers. These forms of political advocacy may ultimately be the most effective way of achieving large-scale pharmaceutical policy reform since they do not compromise individual efforts at accessing unapproved drugs and, unlike social media advocacy, proposals for reform are not specific to individual patients.

Though all forms of advocacy in favor of a more just system of drug regulation are laudable, not everyone who is a bystander to oppression has a duty to oppose it. When opposing oppression requires that one makes oneself a victim of that oppression, people do not have a duty to submit to an oppressive policy out of solidarity with the oppressed. In other cases, opposing oppression would cause greater injustice on balance. These considerations weigh against civil disobedience and in favor of other forms of activism. But as long as the costs are not so high that opposition to an unjust policy would only make more people victims of the policy, people should resist oppressive policies through civil disobedience, direct advocacy, or political expression.

5.5 Democratic Authority and Self-Medication

In 2011 the FDA determined that emergency contraception (Plan B One-Step) could be safely sold over the counter without age restrictions. Kathleen Sebelius, then the secretary of human services, overturned the FDA’s judgment and instructed the agency to maintain age restrictions on Plan B on the grounds that there was insufficient evidence to justify the agency’s decision. President Barak Obama publically supported Sebelius’s decision, and the FDA ultimately rejected an application to sell Plan B over the counter without age restrictions. This reversal prompted the Center for Reproductive Rights to initiate a citizen’s petition and lawsuit against the FDA and Sebelius asserting that the failure to approve Plan B was not justified in light of the medical evidence. In 2013 a judge overturned Sebelius and the FDA’s decision on the grounds that it was made on the basis of “bad faith and improper political influence.”⁴⁸ After a series of appeals, the FDA approved Plan B for over the counter use by all women of childbearing potential.⁴⁹

(p.163) One might think that people who advocate rights of self-medication and patient-driven development ought to favor political reforms via democratic institutions rather than via non-democratic institutions. But the history of drug regulation, from the early calls to regulate pharmaceuticals after the Elixir Sulfanilamide disaster to the Obama administration’s politically motivated opposition to Plan B approval, is marked by a series of democratic impediments to self-medication. Just as the doctrine of informed consent evolved through judicial institutions and interpretations of constitutional law, rights of self-medication should also be insulated from democratic encroachment and protected by constitutional courts. Voters are not reliable judges of whether patients should have rights of self-medication because they suffer from several cognitive biases that blind them to the injustices of regulations and overemphasize the benefits of regulation. To the extent that regulatory agencies are accountable to democratic branches of government, their policies will be informed by voters’ misguided beliefs. Therefore, pharmaceutical policy should be shielded from democratic pressures, like other policies that affect fundamental rights.

The argument in favor of protecting people’s rights of self-medication from democratic pressures goes like this:

(P1) Voters are biased against rights of self-medication.

(P2) If voters are biased, democratic institutions are systematically unreliable at producing just or effective policies.

(P3) If democratic institutions are systematically unreliable, public officials should not rely on democratic mechanisms to regulate access to pharmaceuticals.

(C1) Public officials should not rely on democratic mechanisms to regulate access to pharmaceuticals.

(P4) Public officials must use some mechanism to regulate access to pharmaceuticals.

(C2) Public officials should use non-democratic mechanisms to regulate citizens’ access to pharmaceuticals.

In other words, self-medication should be protected in the ways that other politically vulnerable rights (e.g., freedom of speech and association) are protected from popular efforts to restrict the freedom of vulnerable groups. Public officials should adopt institutional reforms that protect patients’ rights through constitutional provisions, international institutions, and independent agencies.

The first premise of the argument states that voters are systematically biased against rights of self-medication. In addition to regulators’ aforementioned biases in favor of committing Type II errors in order to avoid (p.164) committing Type I errors, the voters whose preferences influence regulators are also subject to various cognitive biases. For example, people are generally optimistic that they will not become the victims of prohibitive pharmaceutical regulations that prevent them from accessing therapeutic medicines because people systematically overestimate the degree of control they have over their lives and health and underestimate the probability of negative events.⁵⁰ At the same time, people are also influenced by availability bias. So when there is an unusual negative event, such as a drug disaster, it more readily comes to mind when considering the benefits and drawbacks of drug regulation; whereas people are less likely to consider less visible harms, such as people dying of diseases.⁵¹ People are also biased in favor of the status quo, so it generally is difficult to convince them of the merits of reform.⁵² And terror management theory predicts that thinking about death or mortality makes people more supportive of authority and the perpetuation of current cultural norms and values.⁵³ Add to that people’s systematically less permissive attitudes toward bodily choices and choices regarding health and drugs, and there is further reason to suspect voters of bias. Additionally, drug use is stigmatized, especially insofar as it is associated with disadvantaged populations. And prejudices against chronically ill and disabled people are common too. So it is not clear that citizens are generally well equipped to judge the merits of self-medication in their capacities as voters.

In light of these biases, democratic institutions are unlikely to assess the merits of proposals for patients’ rights of self-medication. Political scientists and economists have established that voters who are biased influence policy in ways that comport with their biases.⁵⁴ And there is historical evidence of the hazards of systematically biased democratic decision-making as well—democratic majorities often support policies that discriminate against marginalized groups (p.165) out of an (often unjustified) fear that they will be harmed if marginalized groups benefit.⁵⁵

In these cases, even if epistemic or instrumentalist arguments on behalf of democratic institutions succeeded as a general matter, they would fail to justify democratic decision-making in cases where voters are poorly equipped to evaluate evidence and make moral judgments because uninformed and biased decision-making leads to worse outcomes. And non-instrumental rights-based arguments cannot justify giving uninformed and potentially prejudiced voters the authority to enforce policies that violate important rights. Citizens are not entitled to use their power to harm less powerful groups.⁵⁶

Therefore, public officials should be wary of democratic mechanisms when evaluating the merits of self-medication or pharmaceutical regulations more generally. Instead, they should look to the same non-democratic mechanisms that states use to protect other rights from threats from popular opinion. First, constitutional protections and judicial institutions may prove to be a productive path to securing rights of self-medication, just as the doctrine of informed consent evolved through the judiciary in the United States. Second, international organizations may affirm rights of self-medication within human rights doctrines to further support constitutional and judicial efforts on behalf of patients’ rights.

5.6 Conclusion

Self-medication is a political cause. Patients should feel empowered to take drug development and distribution into their own hands. In the absence of political reforms that protect patients’ rights of self-medication, patients may justifiably develop drugs outside the formal mechanisms of the approval process, disobey pharmaceutical regulations, and protest existing policies. I also suggested that patients and their advocates are not morally required to seek the approval of voters and political reform needn’t be backed by democratic support because voters are potentially biased against rights of self-medication. For this reason, constitutional and judicial reforms may be necessary to secure rights of self-medication, just as rights of informed consent emerged through a series of judicial decisions.