Who’s to Say That Medication Is Too Risky?

Peptides have moved from bodybuilding forums into the cultural mainstream. Telehealth clinics advertise them for weight loss and recovery, often outside any FDA-approved indication. Podcasters describe their personal protocols to audiences of millions. HHS Secretary Robert F. Kennedy Jr. has spoken openly about using them himself.

To regulators and much of the medical establishment, this looks like a dangerous collapse of scientific gatekeeping. But it raises a question that has little to do with peptides themselves: who gets to decide which risks competent adults may take with their own bodies?

The peptide boom is only the latest instance of a recurring pattern. A 20th-century regulatory system built around centralized expert judgment is colliding with a 21st-century public that has greater access to information, stronger preferences for autonomy, and less willingness to defer automatically to credentialed authority. At its core, the debate is philosophical as much as medical.

The protective view holds that ordinary people cannot reliably evaluate biomedical risk and that centralized expert review spares the public from its own poor judgment. The autonomy view counters that adults should retain broad latitude over personal risk, especially where evidence is incomplete and specialists themselves disagree. Both have serious defenders. The question is which should govern by default.

Scientific judgment matters enormously. But regulators are not infallible, and medical history contains repeated reminders that they can err in both directions. The FDA’s caution has undoubtedly protected Americans from dangerous therapies; thalidomide remains the classic example. Yet, excessive caution can impose harms of its own. Critics long argued that delays in FDA approval of beta-blockers slowed access to life-saving cardiovascular therapies already available in Europe. The agency can also approve under pressure: in 2021, the FDA cleared the Alzheimer’s drug aducanumab (Aduhelm) after its own advisory committee voted 10-0 against (with one member abstaining), prompting three members to resign in protest. The pattern is not consistent in either direction. It is centralized judgment distorted by the particular incentives regulators face.

The problem is that regulatory incentives are fundamentally asymmetric. Approving a dangerous therapy generates headlines, congressional hearings, and public outrage. Delaying a beneficial therapy imposes costs that are diffuse, statistical, and largely invisible. Regulators face punishment for visible harms but rarely for unseen costs.

Yet, free societies routinely permit adults to engage in activities carrying substantial and well-established health risks. Public health authorities now recognize that no level of alcohol consumption is safe, yet alcohol remains legal and widely consumed. Tobacco kills hundreds of thousands of Americans every year. Roughly 40,000 Americans die in automobile crashes annually. We do not prohibit these activities. We prosecute fraud, impose safety standards, and provide information so individuals can make informed tradeoffs.

Why should emerging biomedical therapies be treated as categorically different? The question makes many experts queasy. They worry that biomedical claims can mislead and that consumers are vulnerable to misinformation. But modern medicine already tolerates substantial decentralized experimentation. Physicians routinely prescribe drugs off-label. Patients weigh side effects, uncertain benefits, and quality of life against one another every day. Medical science itself advances through iterative learning under uncertainty.

None of this is to claim that markets eliminate risk or that misinformation does not exist. It is to recognize that the relevant question is not whether risk can be eliminated. It is who gets to make decisions in the presence of risk, and on what terms.

For decades, Americans largely accepted a system in which government agencies and medical professionals served as the primary arbiters of medical knowledge and permissible treatments. That model is now under strain. The public has greater access to information than at any point in history, stronger preferences for personal autonomy and less willingness to defer automatically to credentialed authority.

Critics will call this shift reckless or anti-science. It is neither. When evidence is incomplete, specialists disagree, and individuals bear the consequences, the case for overriding personal judgment must be made, not assumed. That is not a rejection of expertise. It is a demand for humility from those who wield it.