Pharmaceutical Freedom: Why Patients Have a Right to Self Medicate – Jessica Flanigan
Tesi: se si accetta il principio del “consenso informato”, allora bisogna accettare anche il libero accesso alle medicine
Problema: l’assunzione di una medicina assicura certi benefici con una probabilità dell’x% e certi effetti collaterali spiacevoli con una probabilità dell’y%. Chi deve decidere se assumerla o meno? E chi è l’esperto in materia? L’esperto non è il medico (lui deve fornire x e y) ma il bioeticista.
1 A Defense of Self-Medication
Mary Schloendorff was admitted to New York Hospital in the winter of 1907, suffering from abdominal pain and indigestion.1 Before she was discharged, a physician found a lump in her side during a physical examination. The physician, Dr. Frederick H. Bartlett, advised that Mary be examined under anesthesia to determine what the lump was. Mary replied that she did not want to undergo any operation, but Dr. Bartlett assured her that the exam was only investigational and that she could decide later if she wanted surgery. Still, Mary decided to go home and wrote to her landlady that she was returning. The night before Mary was to leave the hospital, she was awakened several times in preparation for an examination, and each time she stated that she did not want an operation. Mary’s ability to understand her circumstances and make decisions was not impaired during this time. Nevertheless, the next morning she was physically restrained and anesthetized. When she woke up, she learned that a surgeon discovered uterine fibroids and that she had been given a supravaginal hysterectomy. Screaming in pain, she was confined to the hospital. As she recovered, Mary was transferred to a series of hospitals and convalescence homes for months. She developed painful complications related to the surgery, including the amputation of some of her fingers as a result of gangrene. The most significant development in twentieth-century medical ethics is the rejection of medical paternalism of the sort that Mary Schloendorff experienced.
Note:LA STORIA DI MARY SHLOENDORFF
Before the twentieth century, physicians routinely deceived patients, withheld diagnoses, and even performed unwanted medical interventions.
Note:PRIMA DEL XX SECOLO
A 1967 survey of internists and surgeons found that almost 90 percent of physicians had a general policy of withholding cancer diagnoses from patients.2 Some even reported that they falsified diagnoses of patients in advanced-stages of their diseases.
Note:DIAGNOSI DEL CANCRO
principle of self-determination that Judge Benjamin Cardozo famously articulated in his opinion for Schloendorff v. New York Hospital: Every human being of adult years and sound mind has a right to determine what shall be done with his own body;
Just as patients were gaining ever more rights as part of the newly developing doctrine of informed consent, administrative agencies began enforcing legal limits on the kinds of medicines patients could purchase and use…Today, pharmaceutical regulation is pervasive.
Note:+CONSENSO INFORMATO – LIBERTÀ DI MEDICINA
My thesis is that the same considerations that justify rights of informed consent also justify rights of self-medication.
This is not to say that patients should use pharmaceuticals without seeking medical advice.
1.1 Two Motivating Cases
Risky Refusal: Debbie has diabetes and her physician advises her to start insulin treatment. Debbie understands the risks of refusing insulin but is also unwilling to live by a schedule and monitor her medication. Against medical advice, Debbie decides to try to manage her diabetes with diet and exercise. Debbie’s physician is morally and legally prohibited from injecting Debbie with insulin against her wishes.
Note:RISCHIARE RIFIUTANDO I MEDICINALI È CONCESSO
Risky Access: Danny has diabetes and his physician advises him to treat his condition with diet and exercise. Danny doesn’t want to invest the time or energy in diet and exercise and would prefer to just begin using insulin right off. Against medical advice, Danny wishes to try to manage his diabetes with insulin. However, Danny cannot legally access diabetes medication without a prescription
Note:RISCHIARE COI MEDICINALI È VIETATO
laws that prohibit people from accessing drugs are backed by threats of force, which are ultimately threats to a person’s bodily integrity.
Note:PROIBIRE LE MEDICINE VIOLA LA LIBERTA’ DI CURA
1.2 Patients Know Best
The first argument in favor of informed consent can be stated thus: (P1) Each patient is typically in the best position to determine which treatments are in his or her overall interest. (P2) Health workers should aim to promote patients’ overall well-being. (P3) In general, the most reliable way to promote overall well-being is to defer to the expert. (C) Health workers should defer to patients’ judgments about treatment options.
Note:ARGOMENTO DELLA “POSIZIONE PRIVILEGIATA“.
people are generally sufficiently capable of judging what treatments are in their interest, and they have a presumptive advantage over other potential decision-makers. This premise originates with John Stuart Mill’s claim that no one but a person himself can judge whether a risk is worth taking because each person understands and cares about his own interests more than anyone else.
Note:UN PRESTITO DA MILL
In the medical context, bioethicists, including Allen Buchanan and Robert Veatch, have affirmed the principle. Veatch writes, “There is no reason to believe that a physician or any other expert in only one component of well-being should be able to determine what constitutes the good for another being.”
Note:BIOETICISTI A SOSTEGNO
The second premise also assumes that health is only one part of a patient’s overall well-being and states that health workers should aim to promote overall well-being.
Note:SALUTE COME PARTE DEL BENESSERE
A myopic focus on health mistakes the means to a good life for the good life itself, just like an obsession with money or admiration would.
Note:ANALOGIA TRA SALUTE E DENARO
This principle dates at least to Maimonides, who wrote that physicians should treat patients and not diseases.
those who are concerned that other people’s stated judgments differ from what they would judge on reflection may provide resources for further deliberation and offer information and advice to encourage reflective decision-making while also deferring to people’s stated judgments about well-being.
Note:IMPREGIUDICATO L’IMPEGNO DEI TERZI
To illustrate this epistemic argument for medical autonomy, imagine a deeply religious Jehovah’s Witness who believes that it is wrong to accept blood transfusions. While a physician might correctly judge that a blood transfusion is in the interest of her health, the physician might also agree that it is not in her interests all things considered, given her cultural identity and religious commitments.
Note:TRASFUSIONI AL TESTIMONE
we might imagine a cancer patient who refuses chemotherapy in an effort to preserve her fertility, even though alternative therapies are less likely to succeed than chemotherapy.
Note:CHEMIO E FERTILITÀ
cosmetic surgery does not provide patients with any medical benefit, and it carries significant risks. But cosmetic surgeons act permissibly because their patients accept medical risks
1.3 Patient Expertise and Drug Choice
To extend on Mill’s argument, when it comes to a patient’s expertise about her own well-being, it doesn’t matter whether she is making a judgment about accessing or refusing treatment. When Debbie decides to refuse treatment, against medical advice, it is because she judges that treatment is not in her overall interest.
Note:L’ARGOMENTO VALE PER ENTRAMBI I RISCHI
When a physician makes a decision about whether to allow a patient to access a prescription-only drug, the decision is based on an analysis of how risky the drug is, which depends on the severity of the condition it treats and the expected side effects for a particular patient-type. But a physician cannot know whether using a drug is “worth it,” which is precisely the question physicians are required to ask when they are designated as gatekeepers between patients and prescription drugs.
Note:IL MEDICO CHE NON PRESCRIVE UNA MEDICINA
Pharmaceutical regulators are in an even worse position to judge whether a patient should have access to a drug.
Note:IL REGOLATORE È MESSO PEGGIO DI TUTTI
When pharmaceutical policy empowers physicians and regulators to decide whether the risks of a particular treatment are worth it given the benefits, people who have scientific knowledge are empowered to make decisions about other people’s values.
Note:SCIENZA E ALTRI VALORI
we might imagine patients who genuinely do choose against their interests. Whether because of cognitive biases, stupidity, imprudence, or indifference, people make terrible choices all the time and later regret those choices.
Note:IL PAZIENTE CHE SBAGLIA
One would need to show instead that patients are more reliably mistaken about their interests than physicians and regulators.
Note:COSA CI ASPETTIAMO DAL PATERNALISTA
Physicians and regulators are unbiased because they are not experiencing the pain and fear associated with an illness, and they also have much more experience seeing the effect of treatment
Note:ESEMPIO DI ARGOMENTO PATERNALISTA
First, the price of this skepticism is to reject not only self-medication but also informed consent.
even if patients suffer from reliable cognitive biases that impair their ability to perceive and act in their overall interests, physicians and regulators have cognitive deficits when it comes to perceiving another person’s interests.
Note:BIAS COGNITIVI E DEFICIT COGNITIVI
Third, the claim that the relevant characterization of a person’s overall interests refers to her long-term well-being is itself a controversial claim.
Note:CONTA SOLO IL LUNGO PERIODO?
Fourth, even if patients’ judgments about their well-being are not reliable, it doesn’t follow that the judgments of physicians and regulators should prevail. Insofar as physicians and public officials can educate and inform patients in ways that ameliorate patients’ judgments, they ought to, since patients still have greater knowledge
Note:L‘INFORMAZIONE NON È PREGIUDICATA
Another reason in favor of deferring to patients is that patients’ judgments about the effects of treatment choices can potentially become a self-fulfilling prophecy. The mere belief that a treatment will make a patient worse off could make it true that the treatment will make her worse off if she has it.
1.4 Intimate Choices
The most important reason to respect a patient’s autonomy is that each person has the right to decide what happens to his or her own body. Today, physicians and public officials must abide by the doctrine of informed consent, even when it is clear that a patient’s choice will not promote her overall well-being on any plausible account of well-being.
Note:IO SONO MIO
Consider an analogy to romantic choices. Most of us can think of people in our lives who manage their romantic lives in ways that are terrible for their short-term and long-term well-being.
Note:QUESTO MATRIMONIO NON S’HA DA FARE
1.5 Anti-paternalism and Freedom to Choose
One may resist this line of argument by claiming that the fact that people tend to value intimate and personal bodily choices more than other choices does not mean that those choices merit special protection.
Note:L’INTIMITÀ MERITA UN TRATTAMENTO SPECIALE?
if people were unjustified in singling out bodily choices, then perhaps other sorts of entitlements, such as property rights or reputations, would merit further protection as well.
Note:E LA PROPRIETÀ?
Stephen Darwall persuasively argues that paternalistically interfering with a competent adult’s choices reflects a failure to recognize the respect that she is owed as a member of the moral community who has equal status to others.
Darwall writes: The objectionable character of paternalism … is not primarily that those who seek to benefit us against our wishes are likely to be wrong about what really benefits us. It is not simply misdirected care or even negligently misdirected care. It is, rather, primarily a failure of respect,
1.6 Patient Protection
Another reason to support the doctrine of informed consent is that it protects patients from abuse. In particular, even if one is unconvinced by arguments in favor of a general right to choose, one may agree that people have rights against coercion, battery, or fraud…This justification for informed consent is based on Manson and O’Neill’s argument that the doctrine is best understood as a way of preventing physicians from acting wrongly.30 On their account, informed consent is a way of ensuring that all physicians take due care to ensure that their patients are sufficiently informed so as not to be deceived and to protect patients from feeling coerced or pressured to make a particular decision….
Note:TUTELA DAGLI ABUSI
1.7 Ignorance and Fraud
There are three reasons to accept the principle that if a person can consent to drugs with certain outcomes that she can also consent to drugs that carry known and unknown risks. First, drugs with certain outcomes may be understood as drugs that have a 100 percent likelihood of a particular effect. It is unclear why a person would be permitted to consent to a 100 percent likelihood of a single outcome but not a 50-50 lottery between two outcomes.
Note:VALUTAZIONE DEL RISCHIO
1.8 Self-Medication and Unapproved Drugs
Rights of self-medication require changes to the approval process for investigational drugs and changes to the prescription drug system.
Note:IL DIRITTO ALLA CURA E LE REGOLE
Currently, patients are legally prohibited from accessing investigational drugs until they have been approved safe and effective by regulators at government agencies such as the FDA or the European Medicine Agency (EMA). Yet safety is a normative judgment. Officials may certify a drug as safe even if there are some risks associated with its use,
Given that officials tolerate some level of risk regarding drugs, the question is then how much risk is acceptable
One concern is that approval requirements are necessary to ensure informed consent because otherwise patients and physicians would not have enough information to know whether a drug was safe or effective.
the off-label drug market in the United States demonstrates that a market in unapproved drugs is not incompatible with informed consent. In the United States, drugs are tested as effective treatments for particular patient-types with specific conditions. Once approved, those drugs can be prescribed off-label for any condition. Off-label prescribing gives us a glimpse into a world without prohibitive testing requirements…The pervasiveness and success of the off-label market suggests that premarket efficacy testing requirements are not necessary to protect patients….
1.9 Self-Medication and Prescription Drugs
In addition to reforming the approval process, physicians and public officials should also rethink the prescription drug system in light of patients’ rights of self-medication… Epistemic arguments in favor of self-medication support reforms to current prescription drug systems because the current systems all privilege physicians’ and pharmacists’ judgments about treatments, instead of patients’ judgments about whether using a drug is the right choice….
Note:LA RICETTA NEUTRALIZZA IL DIRITTO ALLA CURA
A growing number of students and professionals use neuroenhancements even though they do not have a medical condition that warrants the prescription of the drugs. Under the current system, people without a diagnosis of attention deficit disorder (ADD), or a similar condition, cannot legally buy Adderall because they cannot obtain a physician’s prescription for the drug. One justification for a prohibition of Adderall is that the drugs are not safe enough to be used as neuroenhancements
Note:MEDICINA E DROGHE. IL CASO ADDERALL
Despite these significant risks, physicians are not equipped to judge whether the risks of Adderall are justified for the sake of the cognitive benefits it brings.
Note:ANCORA: CHI GIUDICA?
People can permissibly use alcohol to make going to a club more enjoyable even though alcohol can be dangerous. Students are not forbidden from pulling all-nighters to gain an advantage on an exam, even though sleep deprivation is unhealthy.
Though different, the epistemic and rights-based justifications for informed consent agree that a patient has a special normative relationship to her own life.