Bioethics has transformed from an interest of relatively few religious scholars and philosophers to a vibrant discipline with institutions, conferences, and presidential commissions in the aftermath of scandals dealing with human research. Whether it was the common use of American prisoners as research subjects, the German and Japanese experiments on prisoners during World War II, or the deprivation of available treatment to rural African American men in order to observe the natural history of untreated syphilis, the American public was disgusted at how scientists have used people as a means to gain data, often at the cost of the people’s own health.
In such a context, it is no wonder that the emerging discipline allotted the place of pride to the principle of autonomy, the idea that competent people ought be able to make their own decisions. Hand in hand with this idea was the concept of informed consent: If you were going to use people as research subjects, it could only be after these subjects were able to make their own decisions. They must be competent, not decisionally impaired, whether temporarily or permanently; they must be adequately informed about the proposed research, and, free of any coercion or pressure, they must agree to be involved with it. But even in areas like human subjects research—where the emphasis on autonomy and informed consent were most pronounced—these were never the only principles to be considered. While ethicists disagree over a comprehensive list of principles, there is no disagreement that there are at least two others: justice and beneficence. Thus, even in human subjects research, there are times—for example, when a person shows up at an emergency room unconscious and with no identifiable decisionmaker and nothing that would indicate what his or her wishes would be with regard to experimental treatment — when physicians are obligated to do what they feel would be in the patient’s best interests. If the patient is bleeding heavily and seems the perfect candidate for an experimental blood clotting agent that is being tested in the emergency room, the physician may use it on the patient—thereby, without consent, transforming the patient into a research subject—if the physician believes this to be in the patient’s best interests. Once the patient is conscious, oriented, and able to make decisions, the physician must seek informed consent to continue using the experimental product on the person. But I have raised this case to show that even in the area of human subjects research, where autonomy is the paramount principle, there are instances in which it gives way to other principles, such as beneficence.
In Dr. Flanigan’s thought-provoking essay, she starts out by correctly noting that the doctrine of informed consent requires that physicians respect competent patients’ decisions, even if such decisions seem unwise. But this is not an unbounded duty that makes the physician a virtual captive to the wishes of his or her patient. The physician cannot break laws. If a patient asks her doctor to kill her, the doctor cannot do so (unless they are in a place that permits physician-assisted dying, and even then far more would be needed than just one request to one doctor.) The physician cannot be made to do things that the physician and/or the physician’s institution believe to be unethical. In such cases, the physician is required to give the patient information about other doctors/institutions to which the patient may choose to be transferred. And in certain cases, the doctor’s treatment of the patient is dictated not by the patient’s wishes but by public health need: for example, a person with tuberculosis who is deemed unlikely to complete therapy as an outpatient may be held involuntarily until their disease has been treated, so as to keep others from catching the disease. In other words, autonomy, while often treated as the most important principle in bioethics, is not the only principle. In certain times and places, it can be outranked by other principles. Indeed, in some instances, we prioritize public health so much that we implement community-wide interventions that make autonomy moot. For example, we do not ask permission before fluoridating the water or banning trans fats in restaurant food or smoking in public places.
So what happens when it comes to patients who wish to self-medicate, which Flanigan defines as purchasing and using approved treatments, prohibited drugs, and pharmaceuticals without a prescription? According to the doctrine of informed consent, she argues that patients ought to have unfettered access to pharmaceuticals, so they can use them as they wish with no undue paternalism on the part of doctors, regulators, or any other actors. Rather, “public officials and private healthcare providers should certify drugs and provide information about the risks, side effects, and benefits of using drugs.”
I’m not certain what certifying drugs entails. Perhaps Flanigan envisions the FDA has a role with respect to quality control, confirming that drugs contain what they claim to contain, in the proper dosage, without any unwanted adulterants? But I am frankly unable to foresee a day in which a reputable drug maker would sell products to a patient without a system of regulatory approval. Indeed, in the rare countries of the world without a regulatory system of some sort (the South Sudans of the world), multinational drug companies do not operate.
Setting aside the fact that pharmaceutical companies like regulations that are stable and provide assurances of the rules of operation, what about individual healthcare providers? Could we do away with prescriptions and allow patients to purchase whatever they want over the counter in a pharmacy, guided by the advice and recommendations of their doctors and pharmacists? As someone who suffers allergies, likes “real Sudafed,” and hates having to purchase it from behind the counter, I am sympathetic to this idea. But consumer abuse of Sudafed when it was available over-the-counter (buying it to use in the manufacturing of methamphetamine) is the reason why the product was moved behind the counter and onerous quantity restrictions put in place. In the name of public safety, and in recognition of the fact that over-the-counter Sudafed was, through no fault of its own, implicated in a public health epidemic, state authorities created a system that helps prevent misuse of the product, at the cost of annoying me and my fellow allergy sufferers. Likewise, recognizing that even requiring prescriptions for opioids was insufficient to prevent abuse and a public health epidemic, states implemented other measures – like registries that track how many opioid prescriptions a person fills – in the name of public health.
In public health, there is the idea of “the least restrictive alternative.” We don’t confine a person with TB to a hospital until all less onerous options have been tried and have failed. So perhaps with medicines the idea should be that drugs are sold without a prescription until the evidence makes it clear that something else, like a prescription, is needed to prevent abuse? We do need to be clear however that we are not solely concerned about individuals misusing a drug and harming themselves: we are also concerned about individuals misusing drugs, such as antibiotics, in ways that harm everyone, for example by encouraging the development of antibiotic resistance.
In a scenario where drugs can be sold without a prescription, I would foresee a rise in the number of accidents where patients unknowingly combine medicines that ought not to be combined. Perhaps this could be forestalled by patients informing their physicians of absolutely every product they take, the physician having a very good grasp on drug interactions, and the pharmacist being consulted for an additional layer of assurance. Or we could just use prescriptions, where (provided you use the same pharmacy vendor) the pharmacist has a current record of what other products you may be using (based on your purchase history) and can warn you of possible drug interactions. I do not see this as a tyrannical exercise of state authority over individual liberty but rather as a way to aid the patient understanding the risks of the drugs they have been prescribed and making an informed decision about whether to discontinue one so as to take the other and so on.
Our healthcare system is capable of great miracles: helping infertile people to conceive children, separating conjoined twins, and allowing individuals with HIV to live a near normal lifespan while never progressing to AIDS, just to name a few. But our system also has systematic failings, including physicians seeing patients at such a rapid clip that conversations are often stunted and “informed consent” is often just a shadow of what it should be. When a doctor says, “I think we need to change your antidepressant, so I’m going to write a prescription for Cymbalta, 2 tablets a day,” that is not informed consent. The patient is not told what the relative risks of the new versus the old medication are; what the benefits of the switch would be; or what other options might be considered. The patient is certainly not told how much the new drug is going to cost, either to their insurer or out of pocket, and there is no discussion of the fact that the patient will need to take the drug a while before noticing any effects or that the patient, once on the drug, will need to wean off of it in order to avoid withdrawal. To say that “public officials and private healthcare providers should … provide information about the risks, side effects, and benefits of using drugs” so that patients can exercise their right to self-medicate is to ignore structural constraints that make sufficient information exchange in the healthcare setting unlikely. Perhaps much of the discussion and counseling could be delegated to the pharmacist, but if drugs are available over the counter, with no prescription, patients would likely come to the pharmacy, purchase their desired drugs, and leave, without speaking to a pharmacist. If you create a system in which the patient must speak to the pharmacist at the point of sale (in order to be appropriately educated), how is this any less onerous than requiring a prescription?
Patients come in all forms. Thus, while the majority of them would need counseling and information to make appropriate decisions regarding the purchase and use of drugs, there are some patients on the other end of the scale. They are familiar with drugs, dosages, side effects and benefits, and alternatives, perhaps because they work with these products or for some other reason. In the case of these informed patients, it may be that they do not need physicians and pharmacists and regulators in order to make their decisions about drug use. (I would argue that they still need regulators to ensure products are what they claim to be and are not adulterated, as that knowledge is something than can be gleaned only by testing.) But the vast majority of patients, who either do not have this expert knowledge, who are unwilling or unable to decipher the size 2 font on the literature that comes with their drugs, or who are overwhelmed with dealing with their illness, or even just the day to day demands of life, benefit by having this system in place to guide and to protect them. Recent reporting by Kaiser Health News that found “huge numbers of cancer patients lack basic information, such as how long they can expect to live, whether their condition is curable or why they’re being prescribed chemotherapy or radiation,” underscores my concern that many patients are, for a variety of reasons, not informed enough about their choices and their attendant risks and benefits to be capable of deciding which medicine to try in an unregulated marketplace.
Dr. Flanigan correctly notes that risk versus benefit judgments may vary from individual to individual. But this does not stop us from making policy for populations on all manner of things, ranging from speed limits to what drugs ought be approved to what building materials may be used in housing construction. Some individuals may find these population-based policy decisions too restrictive; others may find them unsettlingly unrestrictive. We aim for a happy medium. With regard to drug regulation, the Food and Drug Administration and its peers around the world are doing so by soliciting input from patients in the drug approval process. Rather than making a decision based solely on the data collected in clinical trials, the regulators are asking patient groups to tell them what is most important to them and what trade-offs, with regard to safety or efficacy, they are willing to accept in order to get a product that addresses these issues of concern. This does not allow every individual patient to make his or her own risk/benefit calculation, but it does allow for representative members of a patient group to make clear their preferences and concerns.
This new approach was first implemented in the 2015 approval of the Maestro Rechargeable System weight loss treatment. This device, which is surgically implanted in the patient, uses intermittent electrical pulses to make the patient’s brain believe that his or her stomach feels full. In a clinical trial, patients who received the system and had it activated lost more weight than patients who had the system implanted but not activated; however, the patients with the system turned on did not lose as much weight as the device developer had predicted they would. Because the study did not meet its pre-defined endpoint, the study was considered to show that the device failed. However, the FDA conducted a study of obese patients who would be eligible to use this device and found they were willing to accept the system’s risks in exchange for the amount of weight loss that it provided. Using this patient input, the FDA approved the Maestro Rechargeable System, despite the failure of the trial on which approval was supposed to hinge.
Between such efforts to make sure that patients’ risk versus benefit tolerances are taken into account and my pessimism that our healthcare system can ever be reformed to the point where all patients, regardless of health status, education, language, or location of treatment, can be fully educated to the point where they can confidentially and appropriately navigate the wide variety of pharmaceuticals available for purchase, I support existing pharmaceutical regulations. I do so because I believe they are the least restrictive alternative that serves both the individual needs of many patients and public health needs. I believe this will remain the case unless we engage in a wholesale restructuring of the doctor/patient/pharmacist encounter, as I’ve discussed above. I also think that relying upon the notion of patient autonomy when you cannot adequately ensure the “informed” part of informed consent is an abandonment of the patient.
Taking into consideration Dr. Flanigan’s concern about patient self-determination, I suggest that she tackle a current issue where I might be swayed in favor of autonomy: the issue of drug advertisements. At this time, only the United States and New Zealand permit prescription drugs to be advertised to patients, and manufacturers claim that such advertising is done in the name of educating patients, particularly those who are less likely to see doctors regularly. However, we know modern advertising techniques are geared toward generating desire for a product. How best, then, ought we strive to allow patients maximal awareness of pharmaceutical products that may be of benefit to them without needlessly inflating drug consumption and its attendant harms, both in terms of costs and risks to patients?
 Thus, if you wish to drink nonfluoridated water you must either move or procure your own source of water; if you wish to consume food made with trans fats, you must go to a restaurant in a jurisdiction without a trans fat ban; and if you wish to smoke in public you must either risk penalty or go someplace else. I’m not saying you can’t do what you want, only that the environment has been intentionally structured, via law, zoning, and the like, to make the undesired activity more difficult to do.
 Liz Szabo, “‘How long have I got?’: Why many cancer patients don’t have answers,” USA Today, June 9, 2017, https://www.usatoday.com/story/news/2017/06/09/kaiser-how-long-have-got…