What Does Patient Autonomy Mean for Doctors and Drug Makers?

Both Craig Klugman and Alison Bateman-House seem to believe that affording patients greater medical autonomy would remove medical professionals from the equation altogether, eliminating “gatekeeping by physicians [and] pharmacists, or “mak[ing]the physician a virtual captive to the wishes of his or her patient.” But these fears are unfounded. Autonomy is not just for patients, but physicians, pharmacists, and pharmaceutical companies, too—each is entitled to act or refrain from acting as she deems appropriate. A doctor who doesn’t agree with his patient’s treatment choices can provide additional information, or give counseling, or even ask the patient to seek another doctor. A pharmaceutical company can refrain from making products available until it feels the treatments are ready. The point is that government shouldn’t stand in the way.

Although Bateman-House fears that deferring to patients comes at the expense of physician autonomy, she also laments that physicians currently abuse the freedom they have, failing to spend enough time with their patients, which she says undermines a patient’s ability to make informed medical decisions.

Even if it’s true that physician consultations aren’t as thorough as they once were, patients today have better access to health care information than ever before. According to the Pew Research Center, two-thirds of U.S. adults have broadband internet in their homes, and 13 percent who lack it can access the internet through a smartphone. Pew reports that more than half of adult internet users go online to get information on medical conditions, 43 percent on treatments, and 16 percent on drug safety. Yet despite their desire to research these issues online, 70 percent still sought out additional information from a doctor or other professional.

In other words, people are making greater efforts to learn about health care on their own. True, not all such information on the internet is accurate. But encouraging patients to seek out information from multiple sources is a good thing. In fact, requiring government approval of treatments may lull patients into a false sense of security. As Connor Boyack, president of the Libertas Institute, points out, “Instead of doing their own due diligence and research, the overwhelming majority of people simply concern themselves with whether or not the FDA says a certain product is okay to use.” But blind reliance on a government bureaucracy is rarely a good idea.

Bateman-House also argues that drug makers would refuse to sell treatments without a system of regulatory approval. But the existing regulatory system provides little incentive for pharmaceutical companies to help patients in need. The reason companies are unlikely to provide their products to patients outside of a government-approved clinical trial is because bad results must be reported to the FDA, even if those results are related to a patient’s other ailments and not the drug itself. These “adverse events” can damage a company’s chances of obtaining final FDA approval and even destroy the company’s financial viability. Yet data showing that the treatment is successful when administered outside of a trial is not counted in favor of the company. Given the legal barriers and disincentives imposed by the current system, why would a company go out of its way to help a patient? (True, the FDA has sometimes said it won’t use these adverse events against a company, but it refuses to put that promise in writing.)

Moreover, regulations severely restrict a drug company’s ability to charge for its products, especially before those treatments receive full FDA approval. The profit incentive attracts investors, which companies need in order to develop effective treatments, and encourages entrepreneurs to invest in developing innovative treatments. If the goal is saving or improving lives, the worst thing government can do is remove these incentives. But it’s the current regulatory labyrinth that creates “a system of all risks and no rewards” for drug companies and imposes barriers on innovation and opportunity. Allowing patients to pursue treatments without a government permission slip would strengthen, not undermine, the incentives to develop and provide those treatments.

Still, Bateman-House advocates for “regulators to ensure products are what they claim to be,” and Klugman argues that we should accept a degree of medical paternalism because “experts  …  make sure … things are safe and available.”

Of course quality control is desirable, but why assume that regulation must come from government? In fact, the benefits that government-imposed regulation purports to provide is often provided better, cheaper, and faster by market-based institutions. Online rating systems like Yelp and TripAdvisor already help consumers make informed decisions about restaurants and hotels. Private certification agencies like Consumer Reports and Good Housekeeping provide safety and effectiveness reviews. There’s no reason to think patient portals and scholarly journals couldn’t serve the same function in medicine.

In fact, the FDA is excessively risk-averse. It “has little incentive to avoid the ‘unseen’ error of blocking new medicines that could ease the suffering of millions of people,” for the simple reason that if it approves a bad treatment, it gets punished, and if it blocks a good treatment, it gets rewarded—but it doesn’t get rewarded for approving good treatments, or punished for delaying them. All the incentives are therefore on the delay side. And the premise of this incentive structure is that the FDA knows best—which is wrong. Neither pharma, nor the FDA, nor the doctor, nor the patient, knows all the information necessary to make the “right” decision about treatment. That’s all the more reason that the government shouldn’t have a monopoly on medical decisionmaking. The decision should belong to the person whose life it is.

Also from this issue

Lead Essay

  • Physicians are ethically bound respect patients’ medical choices whenever patients wish to refuse care. Yet both they and government regulatory agencies are altogether willing to prohibit patients from taking medical interventions into their own hands. In particular, many drugs are unavailable without prescriptions, and this impinges meaningfully on patients’ rights to self-medicate. Jessica Flanigan argues that we should take these rights more seriously. The results, she argues, will include greater respect and trust in medical settings, better health outcomes, and improved overall wellbeing for patients.

Response Essays

  • Patients’ autonomy is a key principle of bioethics, says Alison Bateman-House, and with good reason. Yet others must also be protected, including justice and benificence. These principles mean that many of the regulatory safeguards of modern American medicine are indeed justified. Bioethics must never disregard autonomy, but it is far from the only consideration at hand.

  • Craig Klugman argues that in the field of medicine we need a measure of paternalism to keep from hurting ourselves and others. Doctors and pharmacists train intensively for years to develop an extensive knowledge of which therapies are best for which cases, and to know when they can and cannot be used together. Patients lack this knowledge. They also commonly lack the time to acquire any of it during an illness. As a result they often risk hurting themselves and others when they self-medicate.

  • Christina Sandefur argues that our system of drug regulation is fundamentally unjust: While some dangerous drugs are authorized government, whether with a prescription or without, some other drugs are not available by any legal means, even when patients are informed and willing to bear the risks. Regulation even goes so far as to prohibit certain parties from discussing off-label use of prescription drugs. These are not merely theoretical impositions, either, because individuals stand to live or die in consequence.