Lecture 9: Prescriptions and Pharmaceutical Freedom

Vocabulary flashcards covering the regulatory history of pharmaceuticals, Jessica Flanigan's philosophical arguments for self-medication and patient autonomy, and policy mechanisms like Right to Try laws.

Current Gatekeeper System

A regulatory structure requiring pharmaceuticals to obtain approval for safety and efficacy prior to sale, and mandating a physician's prescription before a patient can obtain them.

S.E. Massengill Company Disaster (1937)

An incident in 1937 where the antibiotic sulfanilamide was mixed with poisonous diethylene glycol into a syrup, causing at least 105 deaths in the US and leading Congress to pass a 1938 law requiring pre-market safety testing.

Thalidomide Crisis

A pharmaceutical crisis in the late 1950s and early 1960s affecting Canada and other nations that led governments to enforce extensive safety and efficacy testing and make access conditional on a doctor's prescription.

Strong Paternalism (Pharmaceutical Policy)

Prohibitive drug regulations that override competent adults' choices regarding what to put into their bodies, privileging expert judgments about health over patients' own evaluations of overall well-being.

Risky Refusal

A scenario exemplified by Debbie refusing insulin, wherein a patient decides against medically advisable treatment and physicians are legally and morally prohibited from imposing it without consent.

Risky Access

A scenario exemplified by Danny seeking insulin, wherein a patient desires a treatment contrary to medical advice but is legally prevented from obtaining it without a doctor's prescription.

Argument from Medical Outcomes

Flanigan's empirical challenge to prescription laws, citing a 1987 study by Sam Peltzman showing that prescription mandates fail to reduce accidental or suicidal poisonings and can worsen health by restricting access.

Epistemic Argument for Self-Medication

The argument that individual patients possess superior epistemic authority over doctors regarding whether the risks and benefits of a drug align with their overall life, projects, and commitments.

Analogy to Cosmetic Surgery

Flanigan's comparison showing that because medicine permits patients to undertake medical risks for purely non-medical benefits in cosmetic surgery, patients should equally be permitted to accept risks for pharmaceuticals.

Normative Judgment (Drug Evaluation)

A value-laden judgment determining whether the benefits of a drug justify its risks, which Flanigan contends is an evaluative decision rather than an objective scientific or medical determination.

Normative Authority Justification

A non-consequentialist justification holding that physicians must respect patients' autonomous, self-regarding choices concerning their bodies, even if those choices run counter to their health or overall interests.

Deontic Constraint

A strict moral rule or prohibition that binds healthcare professionals to respect patient autonomy rather than merely treating autonomy as a value to maximize within a consequentialist calculation.

Adderall

A central nervous system stimulant combining amphetamine and dextroamphetamine used for ADHD, which Flanigan argues competent adults should be legally entitled to purchase without a prescription.

Antibiotic Resistance Exception

A boundary condition to self-medication where Flanigan concedes that antibiotics must remain prescription-only because their widespread overuse creates resistant superbugs that impose direct harms on others.

Expanded Access

An FDA program originating in the 1970s that allows patients with life-threatening conditions to apply for permission to use investigational drugs that have only completed Phase I safety trials.

Special Access Programme

The Canadian regulatory mechanism that allows patients suffering from serious or life-threatening conditions to access unapproved, experimental medications.

Right to Try Laws

Legislation passed by many US states starting in 2014 allowing patients with life-threatening conditions to obtain experimental drugs directly from manufacturers without FDA permission.