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Reconciling informed consent with prescription drug requirements
  1. Nir Eyal

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According to Jessica Flanigan,1 ‘physicians and pharmacists must be legally required to allow universal access to whatever treatments they provide. Citizens have rights of self-medication for the same reasons that they have rights of informed consent.’ In particular, health outcome promotion, welfare promotion and respect for patient autonomy, ‘the most widely cited’ reasons for the doctrine of informed consent (DIC), equally support a libertarian drug access policy. Moreover, they support it regardless of the impact on the patient's future welfare or autonomy or the externalities for others. Outside catastrophic ‘superbug’ scenarios, we should all be able to procure any available drug without prescription, in a ‘behind the counter’ arrangement—after drug contents and risks, fully stated on labels, are assessed for our particular case and explained by pharmacists.

Flanigan's trenchant presentation forces us to question standard justifications of DIC, but remains unconvincing. The spirit of DIC allows some coercive interventions. For example, while it rules out coercing a person to participate in a risky study, it permits coercing non-participation in a pointless risky study. Liberal champions of informed consent typically support coercive seat belt laws, smoking zoning laws, centralised water fluoridation, taxation and traffic regulation. It is true that some bioethicists’ not-very-careful defence of informed consent includes sweeping declarations of the unrestricted primacy of negative rights against being coerced in any autonomous pursuit. Applied consistently, such an unrestricted primacy for non-coercion would have ruled out most drug prescription requirements, as well as research subject protection, seat belt laws and other widely accepted coercive policies.

Flanigan does make the case for non-coercion in the specific area of drug access. First, adducing the historical performance of prescription requirements, she claims: ‘On balance, a right to self-medication would have better medical consequences than the status quo.’ Flanigan's main explanation for the alleged counterproductivity of prescription policies is that they undermine patient trust. When it comes to treatment, experimentation and medication, ‘Patients who know that their physicians won't coerce, trick, or mislead them are more likely to seek medical care….’ But drug prescription requirements only coerce patients not to take certain drugs. They do not link a visit to the clinic or the pharmacy with being coerced to do anything undesired. Flanigan's other explanations are somewhat vague, but she insists that whatever the explanation, it just is a historical fact that drug prescription requirements prove counterproductive. Her evidence comes from three observation studies that compared societies with relatively numerous prescription requirements and ones (synchronic or diachronic) with relatively few. The studies conclude that historically, drug prescription requirements had not enhanced safety and population health, and may have set them back.

Unfortunately, all three studies were financed, aided or ordered by pharmaceutical manufacturers with potential interests in uninhibited pharmaceutical sales. The main study received financial support from the FREE/Lilly Endowment,2 ‘created … by three members of the Lilly family … through gifts of stock in their pharmaceutical business, [which] remain the financial bedrock of the Endowment’.3 Another study actually had an employee from over the counter drug producer Richardson-Vicks ‘help in assembling the data’.4 The final study was simply developed under ‘contract from the World Self-Medication Industry, a trade organization representing non-prescription drug manufacturers’.5 Some author affiliations are also worrisome. The main author of the latter study ‘serves as a consultant to companies with an interest in non-prescription drug regulation’. The esteemed author of the first study is an affiliate of the antiregulation think-tanks Cato Institute, American Enterprise Institute and Heartland Institute, which question even the need to take action on climate-change—anything to thwart regulation. An earlier study by that author, alleging similar counterproductivity in seat belt regulations, seems to have been entirely discredited.6 Absent of independent evidence, Flanigan's historic claim lacks credibility for the time being.

Flanigan adds that health practitioners lack the knowledge and skills to assess patients’ values and life circumstances; the latter extend far beyond health. Patient decision-making would promote patients’ non-health-related welfare better. However, we do not have to choose wholesale between health and patients’ overall welfare/preference–satisfaction, regardless of drug type. When a drug is relatively safe no matter who takes it and medically urgent for many who can be trusted to take it effectively, or crucial for contentious yet important life decisions, it could be sold behind, or over, the counter. Albuterol inhalers for asthma and the morning-after pill may be cases in point. When a drug can be medically harmful or dangerously ineffective when the wrong patient takes it, and the freedom to skip a visit to the doctor is immaterial (say, because asking a physician for the prescription is no more embarrassing or a breach of religious/personal commitments than requesting a pharmacist for the drug), then the balance of health and non-health interests often supports a more cautious policy, such as a prescription requirement – assuming, of course, that the allegation of counterproductivity fails. Flanigan's friendliness towards a libertarian opioid policy notwithstanding, many opioids may be cases in point: opioid misuse already kills 11 000 Americans a year,7 non-medical need of opioids remains rare and patients can report any such need to their physician and, if necessary, switch physicians. If opioid prescription requirements usually help us stay out of harm's way, on balance they promote overall welfare by a large margin.

Flanigan's ‘strongest’ objection to drug prescription requirements is a ‘thoroughly non-consequentialist constraint on the conduct of physicians’. Doctors (and pharmacists) simply have no business interfering with competent patients’ choices: ‘patient autonomy is … a value that physicians should respect’. Such declarations are empty without a good argument. One might be tempted to shore up a right of self-medication on the ground that individuals own their bodies and selves and thus should consume whatever drug they fancy. However, this grounding fails to recognise that drugs are not parts of selves; just because we have the right to govern ourselves does not mean, without further argument, that we should have the right to access anything we please to put in our bodies.

Flanigan attempts a real argument: ‘The justification for DIC relies on the premise that “patient autonomy” is a value and, importantly, that physicians ought to foremost respect patient autonomy, not promote it’. But that does not count as argument enough. ‘Respect’ in the sense of non-promotion simply means a broad descriptive type of behaviour, a certain pattern of refrain or rule-following. On what basis does Flanigan assume that the way to engage the value of patient autonomy is through such refrain and not through promotion? After all, she conceded that ‘when interference would preserve the patient's autonomous capacities in the long run’, such interference would promote autonomy.

Let me conclude by mentioning a consideration that counts for DIC (and so, against most coercive interventions directly in the body, in private spheres and in some life decisions, especially in the course of biomedical research). That consideration probably does not count against coercive interventions in the course of most attempts at drug procurement. The consideration points to the prevalent and persistent image (only sometimes philosophically accurate) of coercion of some forms and degrees and in some spheres and contexts as highly disrespectful of autonomous beings. In particular, forced intervention in the body, especially of a form that tends to be harmful more often than helpful, is usually perceived as disrespectful. Other coercive interventions in our lives can be perceived very differently and remain acceptable.

By way of extreme illustration, take coercive kidney redistribution: from persons with two kidneys to persons with none. Kidney removal can be safe and compatible with the continuous pursuit of most every life plan. Still, coercive kidney redistribution would likely be perceived as utterly disrespectful of our autonomy, and that counts heavily against it.8 Take another example. Although coercive prevention of drug theft is usually permissible, coercively extracting stolen pills from thieves' mouths is usually impermissible, partly because it would be considered disrespectful of their autonomy. For good or for bad reasons, substantial trespass into the body is perceived as utterly disrespectful, and that helps explain its wrong-making tendency. On the other hand paternalistic human subject research is seen as respectful, and that helps explain its legitimacy.

Why should mere perceptions count so much? Partly because systematically ignoring perceived disrespect could result in widespread ‘dignitary’ harm: a sense of shame and humiliation for people treated in ways so perceived, as well as injury to their sense of self-respect, or even their social exclusion, stigmatisation, discrimination and dehumanisation. Moreover the culture of respect for autonomy is beneficial and worth preserving, from a non-consequentialist and certainly from a consequentialist standpoint. Protecting a culture of respect weighs heavily in support of cultivating opposition to coercion in spheres where coercion is likely to retain its public image as an utter violation of the respect. Many bad consequences would follow if regular medical practices were broadly seen as violations of our basic dignity. Arguments remain powerless to dispel that image of coercive intrusion into the body (‘Don't feel humiliated—we forcefully remove the drug from your mouth only because it was stolen/because soft paternalism respectfully protects autonomous will from a person's own addiction and factual misunderstanding’). Combined with the relative explicability of much medical knowledge (pharmacological knowledge tends to be more abstract), the consequences are best overall under a culture of informed consent to virtually any direct intervention in the body.

In contrast, when a coercive intervention appears disrespectful only to philosophical libertarians and not intuitively, that intervention rarely entrenches disrespect. Despite Nozick's attempt to link financial re-distribution to disrespectful enslavement,9 most of us perceive tax as annoyance and not as utter humiliation. Therefore, when taxes do not raise independent moral concerns (financing contestable wars, for example), taxes are scarcely morally problematic, entirely coercive as they may be. Ditto for paternalistic prohibitions on participation in risky but pointless experiments and driving without a seat belt. And ditto for many drug prescription requirements.

Acknowledgments

For helpful comments, I would like to thank Stephen Darwall, Bennett Foddy, Jeremy Greene, Paul Katsafanas, Leah Price, Emma Ryman, Dan Wikler, Jonathan Wolff and Tana Wuliji.

References

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Footnotes

  • Competing interests None.

  • Provenance and peer review Commissioned; internally peer reviewed.

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