Tear Up the Permission Slip: Medical Autonomy Is a Fundamental Right

Thousands of people every year suffer and die in the United States, while treatments that could help them are sitting on a shelf. That’s thanks to the outcome of a slow and expensive bureaucratic process by which the Food and Drug Administration (FDA) evaluates potentially lifesaving medicines and treatments. That process takes an average of fourteen years and $1.4 billion for every drug.

Arguing in favor of a patient’s right to self-medicate, Dr. Jessica Flanigan points out that under our current system, “people may consent to use dangerous drugs,” but “cannot consent to policies that cause them to suffer or die while waiting for potentially beneficial treatment.” But it’s worse than that. Our system is not just cumbersome and costly; it’s fundamentally unjust.

That system allows people to take dangerous medicines (cancer-treating chemotherapy is essentially poison, and even acetaminophen kills more than 400 people per year), or to end their lives with a physician’s help. But it forbids them from trying medicines that might cure them or alleviate their suffering.

And while the government allows healthy volunteers to be paid to test medicines that could be fatal to them, it prohibits dying patients from trying investigational medicines that the FDA has deemed safe enough for human testing but that may have unknown side effects. But even that isn’t always the case: under the FDA’s “compassionate use” program, a lucky few—very few—can be granted access to medicines that are still going through clinical trials. And, of course, a patient who can afford it can always fly to Europe or Asia to obtain medicines that are available there, but are still barred from the market by our own FDA.

In other words, our system does not entirely prohibit patients from taking medications with unknown or harmful properties. Rather, it permits exceptions on a limited and arbitrary basis, rather than allowing access on a single, principled foundation. For example, the FDA has made exceptions to its own rules prohibiting access to unapproved treatments. The results of such arbitrariness are horrifying experiences such as that of Jenn McNary, whose sons Austin and Max were diagnosed with Duchenne’s Muscular Dystrophy—an incurable, fatal, degenerative muscle disorder. Jenn tried to enroll both boys in a clinical trial for a promising treatment, but Austin’s disease had progressed too far for him to qualify. Jenn was forced to watch while one son’s condition improved significantly under treatment, and her other son’s condition worsened until he could no longer dress or use the restroom without help. Thirteen-year-old Max became 16-year-old Austin’s caregiver.

There are plenty of other, similar stories, all illustrating the same theme: when government makes the decisions instead of patients themselves, not only does that violate a cornerstone of medical ethics—patient autonomy—but it also leads to arbitrary and unjustifiable outcomes. A freer system, which would not force patients to get a government permission slip, would be both more just and more equal: it would extend to everyone the same permission to use treatments that is already enjoyed by those fortunate enough to get a special exception, or who can afford to travel outside the United States for treatment. A freer system would respect patients as individual humans deserving respect, rather than as subjects in a science experiment, which is what the current system does.

This wasn’t always the case. As Dr. Flanigan explains, federal drug regulations focused at their inception on ensuring that products marketed to the public were safe and correctly labeled, so that patients had truthful information to make informed decisions for themselves. The law did not require manufacturers to submit information to the FDA before marketing. But federal law gradually shifted from a focus on empowering patients, to a paternalistic approach—one that is often preoccupied with erecting roadblocks. This reached fruition in 1962, when the law required manufacturers to “provide substantial evidence of effectiveness for the product’s intended use.” Thus, although the FDA is not authorized to regulate medical practice at all, its prohibition on medical access imposes de facto regulation on doctors nationwide.

Dr. Flanigan may even understate the extent of paternalism in the United States. Federal regulations not only block patients from making treatment choices; they have taken away the tools patients and doctors need to make informed choices. Consider the problem of off-label treatment, the term for using medicines to treat conditions other than what the FDA approved that medicine to treat. Off-label treatment is legal—Medicaid will even pay for it—but the government routinely censors the communication of valuable and truthful information about off-label uses that could help doctors and patients make informed decisions. Federal law strictly limits how pharmaceutical companies—which know the most about their drugs—can share information about legal off-label uses of their products.

That censorship doesn’t just hurt patients; it violates the constitutional right to free speech. Yet companies are subject to criminal penalties for communicating to doctors valuable and truthful information about lawful off-label uses for approved treatments. As the Supreme Court put it forty years ago, “information is not in itself harmful … people will perceive their own best interests if only they are well enough informed, and … the best means to that end is to open the channels of communication rather than to close them.”

But rather than ensuring that physicians and patients know what they need to know to make their own decisions, the government has become the decisionmaker, limiting what people can say, restricting what doctors can prescribe, and dictating what patients can take—all because it thinks it knows what’s best for us. Except, of course, for those who can afford to escape from the regulatory straitjacket, or who get a special exception somehow. That’s unjust and unethical—and often unconstitutional.

Defenders of the status quo often seem to assume that patients can’t be trusted to make their own choices because they don’t know all the information necessary to make the best choices. But that argument endorses an old, long-exploded fallacy: that government officials will have better knowledge, or will make better choices than patients will, because they aren’t self-interested or biased in other ways. But the regulatory system is not risk free—it’s just better at hiding the risks or passing the buck. No system will ensure against all risks. The real question is, who should ultimately decide what level of risk is “acceptable” to a patient—government officials, or patients themselves? True, people will sometimes make uninformed choices, or choices that strike others as foolish or misguided. But that’s already the case today—after all, herbal supplements, magnetic bracelets, and other quack devices are sold freely without FDA oversight. And there are documented cases of the FDA restricting or permitting access to medicine based on politics, not on science.

Respecting the right of patients to self-medicate is not an anti-science position, although some have tried to suggest that. Rather, as Dr. Flanigan says, the question of acceptable risk “is not a medical or a scientific judgment—it is a normative judgment that may vary from person to person.” It’s true that patients may make bad choices—that’s true whether or not the treatments are FDA approved. But one thing we know for sure doesn’t work is a bureaucracy that deprives people, especially the terminally ill, of the freedom to decide for themselves. The right to live as we see fit is what makes life more than mere existence.

Medical paternalism is wrong because it treats fully independent individuals as children who should be protected by the state from making the “wrong” decisions. But free people must be free to make bad decisions—and to enjoy the rewards or suffer the consequences. Otherwise, they aren’t free. Indeed, one of the most controversial elements of the Affordable Care Act—the Independent Payment Advisory Board—garners bipartisan opposition because it empowers government officials to make decisions about healthcare not on the basis of a patient’s needs, but based on bureaucratic spending limits and one-size-fits all political decrees. A system that puts bureaucrats in charge of what medical care people should get will undoubtedly deprive patients of access to needed care, increasing the politicization of medicine at the expense of individual decisions.

When he ran for president, Barry Goldwater said, “We do not seek to lead anyone’s life for him. We seek only to secure his rights and to guarantee him opportunity to strive.” The right to medical autonomy is the right to hope—the opportunity to strive—the freedom to choose what chances to take and how to answer life’s hardest questions.

That’s why the Goldwater Institute developed the Right to Try initiative. Now law in 37 states, Right to Try statutes protect the right of terminally ill patients to access medicine that has received basic safety approval from the FDA—and that is being given to patients in ongoing clinical trials—but that has not yet received final approval for sale. The success of Right to Try laws, still in their infancy, are already corroborating Dr. Flanigan’s statement that scaling back prohibitions can have good health effects. When FDA officials told Houston Doctor Ebrahim Delpassand that he could no longer treat cancer patients with a medicine that had already completed three rounds of FDA testing and has been available in Europe for years, he turned to Texas’s Right to Try law. So far, he’s treated some 100 patients—many of whom were told they had only months to live, but are still alive a year later.

Dr. Flanigan’s proposal to eliminate the government permission slip for medications might sound radical, but if patient autonomy is to be respected and lives saved, then much more is required than merely reforming our broken system. We must challenge its very foundations. Why should government have the power to make life-or-death decisions for individuals? After all, the life—the joy and the suffering—belongs to the patient, nobody else. Medical reforms must not be focused on finding different ways to beg for government permission. It should focus on tearing up the permission slip.

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.