The central problem of policies that restrict access to pharmaceuticals to prescrip- tion is paternalism. The primary purpose of such policies is to protect consumers from bad decisions they might make about the use of drugs if they have unrestricted access. We first need to be clear on exactly what is meant by paternalism and why it is a problem.
The Definition of Paternalism
Paternalism describes an action or policy whereby one person acts for the purpose of benefitting another against that person’s substantially autonomous choice (Dworkin 1972, 1988; Gert and Culver 1979). From this definition, it is clear that only persons who have the capacity to make substantially autonomous choices about the issue at hand can be the subjects of paternalism. Paternalism is always an action that violates autonomy, and it is for that reason that it is morally suspect.
Hence, taken literally, one cannot act paternalistically toward small children or mentally incompetent adults who do not possess enough autonomy to be violated.
Similarly, actions or policies undertaken to benefit others or protect them from harm do not count as paternalism. This is true even if the one who is the target of the action also benefits in some ancillary way.
Similarly, actions taken to protect the welfare of those who are so addicted to a chemical that their actions are not substantially autonomous are not rightly consid- ered paternalistic (Faden et al. 1986). There is no substantial violation of autonomy.
The term “substantial” is important. It recognizes that people and their actions are not rigidly classified as either autonomous or nonautonomous. Autonomy varies by degree and by the nature of the decision being made (Buchanan and Brock 1989).
Autonomy is sometimes said to be a “threshold concept” (cf. Buchanan & Brock:
26–29). People are thought either to possess enough autonomy to make choices on their own, in which case they can be said to be “substantially autonomous,” or they fail to reach the threshold, in which case they can be said to be substantially nonautonomous.
Prescription Paternalism: The Morality of Restricting Access to Pharmaceuticals
The Implications
A psychiatrist who decides to breach confidentiality of a patient who plausibly claims he is about to do serious harm to another is not acting paternalistically if the motive for the breach is the protection of the third party.1 This is true even if it is plausible that breaching confidentiality in a way that will stop the patient from harming the other will also benefit the patient by protecting him from the punish- ment that would likely result if he carried out the threat.
Similarly, in the psychiatry example, if the patient is so psychotic that his actions could be said to be not substantially autonomous, breaching confidentiality even for the purpose of benefiting the patient would not count as paternalism since it would not violate the patient’s autonomy. This may not be the obvious use of the language of paternalism. One might claim that since the word paternalism derives from the root word that means “father,” it is odd that one cannot be paternalistic to a child or other person who is not a substantially autonomous agent. Nevertheless, the moral bite of the concept of paternalism is that it involves the violation of another’s auton- omy. Acting to benefit another who cannot autonomously choose some other course of action cannot, by definition, compromise that individual’s autonomy. Hence, paternalism, at least as the word is used here, has to involve acting for the benefit of another in such a way that the other person’s autonomy is violated.
Sometimes actions to benefit someone who is not substantially autonomous are said to be weak paternalism (Beauchamp 1977: 67). This term is better reserved for a narrower kind of case in which real paternalism with a violation of autonomy occurs. If a militant anti-paternalist encounters someone acting strangely in a way that endangers the actor’s safety, the anti-paternalist might be inclined to intervene to protect the stranger from himself. Someone standing on a bridge threatening to jump might trigger an inclination to restrain the stranger. In such a case, a militant anti-paternalist might believe that, if the stranger knows what he is doing and is substantially autonomous, he has the right to jump, but if he is so deranged as to be substantially nonautonomous, he should be restrained. If one were to intervene long enough to assess the mental state of the stranger, one might discover he, indeed, knows exactly what he is doing and can give rational reasons for his action. The militant anti-paternalist would at that point presumably step aside, but during the time when he is intervening in order to do an assessment, he might well feel justified in his intervention.
In this example, the intervention would really be paternalistic in the sense of violating the autonomy of a substantially autonomous agent, but it is justified because it was necessary to rule out the possibility that the stranger was deranged, thus nonautonomous. Sometimes the phrase weak paternalism is used in this case to refer to the instance when real paternalism occurs, but it is necessary to determine the mental state of the subject of the paternalism. On the other hand, if the stranger continues to be restrained after he is determined to be substantially autonomous,
1 See Tarasoff 1974.
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any action for the purpose of benefiting that individual can be called strong paternalism.
The Liberal Critique of Restricting Access to Pharmaceuticals
The most obvious problem with policies that restrict access to pharmaceuticals to cases in which a physician or other health professional has signaled approval by writing a prescription is that these are blatant cases of paternalism. The primary purpose of the policy is to protect the potential consumers of drugs from the harm that they can do to themselves. Even if the consumers are sufficiently autonomous, the policies restrict their freedom to purchase and use medicinals that they believe are beneficial. We can call this the liberal critique of restricting access to pharma- ceuticals to prescription. It is a policy designed to benefit the consumers by protect- ing them from themselves in spite of the fact that the consumers are presumed to be substantially autonomous agents.
One gets a sense of how controversial this might appear when one compares it with similar policies applied to alcohol, tobacco, guns, rat poison, household clean- ers, and so forth. Any of these latter items can pose serious threats to the one using them, yet we generally permit unrestricted access to substantially autonomous beings. We restrict the right to purchase for children and others who are not compe- tent, but we let competent adults make these purchases without supervision.
Moreover, we presume the adult is competent to make the purchase unless there is evidence to the contrary.
In fact, the case for restriction of alcohol, guns, and poisons seems much stronger than for pharmaceuticals. There are much greater third-party risks from alcohol and arguably from guns and poisons than from almost all drugs. Since the “harm to others” principle provides a basis for restricting access, it would seem reasonable that these substances be more properly the target of controls. On the other hand, almost all pharmaceuticals, if they are dangerous at all, are dangerous primarily to the consumer.
There are, of course, some exceptions in which pharmaceuticals pose a danger to third parties. Methamphetamines, narcotics, and possibly agents that have a side effect of making one drowsy could all be restricted on the grounds of risk to third parties, but these constitute a very small subset of pharmaceuticals. Most, like pro- pranolol, if they are dangerous at all, are primarily of danger to the consumer.
One might respond by pointing out that some pharmaceuticals can be dangerous to some subset of people who for genetic, psychological, or other reasons are at risk in ways they do not know about. This is also true, however, for alcohol and other agents that are freely available even to the subset who do not know that they are at unique risk. Even over-the-counter medications, generally thought to be particularly safe, can pose serious health risks to some subsets of the population with unusual risk factors. Aspirin is dangerous for people at risk for hemorrhagic stroke or gas- trointestinal bleeding that can be rapidly fatal.
Prescription Paternalism: The Morality of Restricting Access to Pharmaceuticals
The reasonable conclusion is that public policy restricting access to pharmaceu- ticals is out of line with similar policies that permit ready access to competent adults for other agents that pose a danger to the consumer (in addition to posing third-party risks). It makes sense to restrict a small group of drugs that pose real risk to third parties—alcohol, amphetamines, and addictive drugs like narcotics and nicotine. It also makes sense to control substances that can render one nonautonomous—like addictive agents. But a wholesale restriction on access to prescription drugs seems unjustified from the point of view of one who generally accepts the moral premises of a liberal society that permit competent adults to use their own judgment to make purchases even if some of those purchases can end up harming the purchaser. A much better case can be made to restrict alcohol, tobacco, and rat poison than to restrict the typical legend drug. Perhaps we need a finer-grain distinction that cap- tures the in-between group of drugs. I will suggest some options below. Treating all pharmaceuticals currently restricted to prescription access as more restricted than alcohol, tobacco, and rat poison seems indefensible.
Of course, not everyone is a pure anti-paternalist. Some would accept the moral legitimacy of relying on calculations of benefit to justify violations of autonomy.
That is to say, some accept the moral legitimacy of paternalism, even strong pater- nalism, in cases in which the potential risk to the substantially autonomous person is great enough to outweigh the offense of the autonomy violation. Even the strong paternalist, however, must recognize that the one acting paternalistically must be confident that his or her calculation of the potential harm to the substantially auton- omous agent is reliable. One cannot legitimately act paternalistically if there is good reason to doubt that the paternalistic one lacks the ability to know that the interven- tion will, on balance, really be beneficial. Thus, the strong paternalist must have sufficient justification of his or her belief that intervention will be better for the target of the paternalistic action.
The Empirical Critique
One necessary condition for justifying paternalism is that one must be confident that the paternalistic policy will, in fact, produce good for the target of the policy. If the paternalist is not confident that his or her action will benefit the recipient, then the restriction is not justifiable.
Is the Patient Better Off with Current Restrictions?
The case of the man on vacation in Florida without his propranolol illustrates the problem. There are lots of reasons why patients would benefit from being freed from restriction on access. Getting the drugs would almost certainly be much less expensive and less time consuming. At least if one needs a pharmaceutical when
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one does not have access to one’s physician, a policy of open access would certainly provide prima facie benefits to the patient.
There would be more subtle benefits of open access as well. If the patient made purchases without the requirement of a physician’s prescription, the patient would surely take more responsibility for the use of drugs. Under the present system, patients presume they are in good hands and that their doctor can figure out what is best for them. This, unfortunately, is not always the case. There is good reason to believe that often physicians are not in a position to be capable of determining exactly which drug use is most beneficial to the patient. If determining what is most beneficial is a subjective matter, based on the patient’s beliefs and values, there is no reason to assume that the physician can make these evaluations accurately. In short, doctors really cannot know what is best for their patients. They, no doubt, can more accurately predict the effects of the drug than the patient can, but they are not in a position to know whether those effects are beneficial from the patient’s perspective and, assuming they are beneficial, whether some other drug, dose level, route of administration, or manufacturer would be deemed better based on the patient’s unique and subjective value framework. Moreover, having the patient as an active participant in the doctor-patient relation may offer great benefits. If the patient per- ceives that he or she is the final decision-maker with the authority to purchase or refrain from purchasing pharmaceuticals, more careful assessment of the risks, ben- efits, and alternatives is likely to result.
Of course, some terrible things might happen if patients are free to purchase pharmaceuticals on their own. They may not adequately understand the nature of a drug’s actions and may fail to grasp the unique risks that their disease, body type, and genetic makeup could pose. Any rational patient will, of course, need to rely on the physician and other health professionals as the authorities on the diagnosis and prognosis of their illnesses, the presentation of a reasonable range of plausible alter- native therapies, and the like. One would hope that wise patients armed with the right to buy what are now prescription drugs would exercise caution and avail them- selves of the opportunity to get expert input on the medical facts. Nevertheless, sometimes the patient will surely be better off without the current restrictions, espe- cially if the patient is prudent enough to make judicious use of professional advi- sors. Although patients are sometimes described as having lost autonomy because of disease and disability, a very large portion of patient/physician interactions involve healthy patients receiving physical exams or therapies for chronic diseases that in no way can be said to compromise autonomy. The vacationing patient who forgot his propranolol is an example. On the other hand, occasionally patients’
autonomy is significantly compromised, but in those cases, normally a surrogate—
parent, spouse, or significant other—should be in the lay decision-making role.
Thus, even if we recognize the fact that physicians possess knowledge about medi- cal facts of certain pharmaceuticals that patients usually lack, they have no basis for making the value judgments that can better be made by substantially autonomous patients or their surrogates. It seems that physicians ought to play a significant role in patients’ access to drugs, but that role should be limited to education about the
Prescription Paternalism: The Morality of Restricting Access to Pharmaceuticals
relevant medical facts and should exclude necessary inputs about nonmedical facts as well as about the value judgments needed to make a proper therapeutic choice.
In many cases, it is probably wiser to permit the patient to exercise discretion in whether to consult an advisor. The uninsured poor have a very limited range of choices. If funds are limited, many choose to go without any medical care—physi- cian consultation or prescription—because they cannot afford the full ritual of see- ing a doctor, paying for tests, and getting a prescription filled. It is not obvious that the current requirement of getting a prescription from a physician to gain access to legend drugs is in the patient’s best interest.
The Doctor Can’t Know What Is Best
There is an even more subtle problem. Relying on a professional medical expert to prescribe what he or she thinks is best runs afoul of a mistake in the model for medi- cal decision-making in the modern era. The model of modern medical decision- making is that there is a class of well-trained experts who can diagnose, review treatment alternatives, and choose what is best for the patient. This has, in fact, been the dominant ethic of physician ethics since the Hippocratic era (Veatch 1978), but in the twentieth century, an adjustment was made. The clinician was still deemed authoritative in matters of diagnosis, prognosis, and the expected effects of treat- ment alternatives but was expected to test his or her judgments about these matters of medical fact with standard conventions of modern science: peer review, random- ized clinical trials, and other devices to test the individual clinician’s understanding of the facts against the consensus of experts and the best scientific knowledge (Veatch 2012). What remained was the assumption that “doctor knows best,” that is, that once the diagnosis and prognosis were established (now based on the best stan- dards of medical science), this could lead to a professional judgment about what was best for the patient. Hence, medicine held out the view that there were objective standards of “medically indicated treatments” and among alternative treatments the science could determine a “treatment of choice.” Medical textbooks could specify what the appropriate treatment was for any given patient’s condition once that patient’s condition was specified sufficiently.
This assumption that physicians (aided by standards of peer consensus) could know what was best for the patient was what was behind the model of modern medi- cine, which included the requirement that treatments be “prescribed” by physicians and that patients—presumably having less knowledge of these medical facts—were not capable of deciding what was appropriate except in the most trivial cases of eas- ily diagnosed problems for which safe, simple, and reasonably effective treatments were available for purchase over the counter.
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The Emergence of the Ethically Exotic Case
By the end of the twentieth century, we began to discover that this model of modern medical decision-making was flawed in a crucial way (Veatch 2009). We first dis- covered the problem in the last decades of the century when considering medical interventions in a few medical situations that could be called “ethically exotic.” The care of terminally ill patients, the pregnant woman, or those contemplating contra- ception or sterilization were the opening challenges to the model of modern medical decision-making. We discovered that a physician with complete medical facts and complete knowledge of treatment alternatives was nevertheless helpless in deter- mining what was best for a terminally ill patient. For the elderly patient with meta- static cancer, was aggressive, experimental treatment or hospice care better? Should patients receive life support, or should it be omitted in order to let the patient die?
We discovered that all the knowledge of medical science in the world could not tell us what was best for a patient. It was a value choice about which the patient’s physi- cian could not be presumed to be expert.
In the case of a pregnant woman with a genetically afflicted fetus (or simply one who did not want to have a baby), is terminating the pregnancy or carrying it to term best for the patient? Once again perfect knowledge of obstetrics could not tell the answer. Is contraception best for an unmarried teenager who is sexually active? It is not a question a medical education should be able to answer. In the mid-twentieth century, doctors attempted to decide what was best for their patients based solely on the medical facts. They imposed aggressive life support on permanently vegetative patients (In re Quinlan 1976). They decided whether a 30-year-old married woman with fewer than four children should be sterilized (Scrimshaw and Pasquariella 1970). (A rule known as the 120 rule was used. The woman’s age multiplied by the number of children she had had to equal 120 before sterilization was acceptable.) Physicians had to give their approval before a woman could have an abortion.
We gradually began to realize how irrational this was. The physician, even with perfect knowledge of the medical facts in these cases, did not have a basis for decid- ing which treatment was best for the patient. Deciding the best treatment required imposing an evaluative judgment—a religious or philosophical choice—on the medical facts. Moreover, it became clear that physicians had no unique expertise in making these value judgments even if they were obviously expert on all the medical facts. In fact, there was in some cases reason to believe that physicians as a group were systematically biased in their evaluative judgments. For example, data revealed that physicians had an unusually high fear of death (Feifel et al. 1967) perhaps because students with high fear of death or unusually traumatic childhood death experiences chose to go into medicine. And, they tended to make judgments in ter- minal illness cases that led to aggressive provision of life support.
Whether physicians as a group had tendencies for certain moral and other evalu- ative biases, there was no reason to assume that an individual physician (or even one aided by peer review and the consensus of the profession) should be deemed expert on the evaluation of terminal illness care choices, decisions about whether to abort a pregnancy, or choices about the use of contraception. Temporarily, society began
Prescription Paternalism: The Morality of Restricting Access to Pharmaceuticals