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.