Autonomy without Warrant; Information without Guidance

In her original commentary and response to Dr. Bateman-House, Dr. Flanigan argues that autonomy should outweigh all of the other principles of medical ethics. However, she offers no philosophical or empirical reasons as to why. Autonomy is actually a recent construction. The concept finds its origins in the ideas of Immanuel Kant (1724-1804) who defined the term as meaning an ability to rationally deliberate and choose to follow the moral law. Autonomy, thus, is a characteristic but not a defense or a reason. The way Dr. Flanigan uses the term is from the 1970 book Principles of Biomedical Ethics by Dan Childress and Tom Beauchamp. These authors did not privilege autonomy and in fact stated that all four principles (autonomy, beneficence, nonmaleficence and justice) had to be balanced before making a moral choice. In the following seven editions of this book (most recently 2017), the authors warned against privileging autonomy.

We should also remember that these four principles are simply “guidelines to moral deliberation” that categorize parts of consideration that one should do when making a choice. The principles take elements of philosophy and practicality but by themselves have no force of philosophy, morality, ethics, or law. Dr. Flanigan’s insistence that only the guiding concept of autonomy should be used in decisionmaking contradicts her acceptance of seat belt laws and other cases where harm to others could curtail its application. If one privileges autonomy, then harm to others would not be a factor. In practice then, she does accept a balancing of principles (despite her statements otherwise) but only when autonomy is privileged when it is convenient. 

Dr. Flanigan’s statement also has some factual errors. Although she claims that drugs are responsible for the increase in average life expectancy, such a claim is incorrect. The largest increase in human lifespan occurred in the late 1940s and was a result of paternalistic public health sanitation efforts—dealing with sewage and better nutrition. The U.S. Centers for Disease Control attributes the increase in lifespan to motor vehicle safety, workplace safety, safer and healthier foods, nutrition, hygiene, family planning, fluoridated drinking water, clean water, sanitation, blood pressure control, and reduction in tobacco use. The only drugs they list are vaccines. Remember that when penicillin became available to the public in 1942, life expectancy was 64.7 (male) and 67.9 (female) which was a large increase from 1900 (46.3-male; 48.3-female). Thus, lifespan had already increased dramatically well before modern efficacious drugs even hit the market (even today, 70 years later, we’ve added only 10 more years of life expectancy). The U.S. today has the lowest life expectancy of any industrialized nation because of our high maternal and infant child mortality rates, high body-mass index, and lack of universal health insurance coverage. In effect, the lack of emphasis on public needs and paternalism in our society is what keeps our life expectancy so low compared to the rest of the industrialized world.

In creating an analogy, Dr. Flanigan offers a list of things that “officials do not legally prohibit people from” doing and lists “drinking alcohol.” Of course, the sale and consumption of alcohol is highly regulated. One must be 21 years of age, above the age of majority, to purchase and consume. Society limits the activities that a person who has consumed may undertake (driving, flying a plane, performing surgery). In many places, alcohol cannot be drunk in public and in others, there are no sales during certain times of the week (like on Sunday mornings). Similarly, society controls the purchase and consumption of tobacco. Private insurance companies charge different rates on health and life insurance based on one’s history of tobacco and alcohol use. States require everyone in a car to wear a seatbelt. One could argue that not wearing a seat belt is a personal choice, that in an accident if you go through the windshield, you hurt only yourself. But the reality is that the emergency services (EMT, police, fire, ER) harms others and costs others money (tax dollars supporting those services). Simply put, the government regularly restricts are rights to act when such actions can pose a harm to others or ourselves. Except for prisoners, the United States does not recognize a right to health care, never mind a right to whatever drugs you want. The closest we come is EMTALA which requires hospitals to evaluate and stabilize patients, but not to treat, cure, or make better. There is no right to self-medication recognized under law or ethics—otherwise there would not be such a battle concerning the use of medical and recreational marijuana.

Ms. Sandefur points out that there are loopholes in our prescription system, with which I agree. But her suggestion to jettison the whole system is like throwing out the baby with the bathwater. The answer is to remove the loopholes, not to abandon a system that has saved millions of lives and billions of dollars. The drug thalidomide was responsible for 10,000 children born with birth defects (only 50% survived) worldwide in the 1950s-60s. In the United States, the FDA required more rigorous testing and never approved the drug. The result is that in the United States, there were only 17 babies born with thalidomide-related problems. If an open system had been in place, those U.S. numbers would have been far higher.

Ms. Sandefur claims that Right-to-Try laws have been successful. The scientific evidence that open access to drugs saves lives does not exist. The case of Dr. Delpassand remains a myth and is the one story touted over and over. As a radiologist (not an oncologist), he would not have treated patients with cancer (unless he was working outside his scope of practice). He also has not produced any records or scientific evidence and has not answered repeated questions from the media. Claims absent scientific data should not be the basis for anyone in making decisions. In terms of making an argument, a single case study is a logical fallacy, meaning that it proves nothing. In fact, for every claim of benefit, one can easily find a story where someone was harmed by compassionate use of experimental treatment, especially since it is not unusual for trials to show that drugs make things worse for patients, as well as sometimes benefiting them.

The FDA approves well over 99% of all requests for compassionate use. The obstacle is the manufacturers, who do not want to give unproven treatments to patients. Why? If something goes wrong they could face not only liability, but a public relations nightmare that could prevent a drug from ever reaching market. If one person has a bad outcome in a clinical trial with 1,000 participants, then that is a data point. If one person has a bad outcome and that was one of two people who received the drug, then the drug is finished and will never be tested nor make it to market. Experimental drugs are just that, experimental. An open market plan will actually lead to fewer drugs reaching market because companies will not want to take the risk of bad PR and lawsuits.

Also consider that no insurance plan in the United States pays for experimental treatment. Thus, a family who is given such access has basically been given a greenlight to bankrupt themselves. Or, if they are of lower socioeconomic status, to see something they want but can never attain. Right to try increases social inequality giving the wealthy access to experimental treatments. For everyone else, the price will put the drug out of reach. An experimental stem cell treatment for ALS, a disease with no cure, was made available to patients but none took up the opportunity. Why? The procedure would have cost $100,000 per patient with no scientific evidence that it would work. Right-to-try laws have one purpose, to dismantle the FDA at the cost of safety and evidence-based medical care, not to protect people.

The reality is that the vast majority of educated experts in health law, health policy, bioethics, and medicine believe that these laws are a bad idea that will harm patients in the short and long run. In my personal conversations with executives at pharmaceutical companies, they are also against this idea of an open use, right-to-try, policy. They feel that (a) the lack of mandated testing will increase harms to patient, (b) create an unfair playing field for companies, and (c) expose them to a great deal of liability.

More information for patients is always better. However, the source of the information is key. For medicines, that source needs to come from scientific trials, not from patient blogs, personal experiences, wikis, or other ad hoc wellsprings. Individual use without control for variables is not helpful for anyone trying to making choices. The idea that open use enhances autonomy and liberty is a misconception because the information on which these decisions are made, absent rigorous trials mandated by the FDA, would be worthless. Good decisions can only come from good facts, and a libertarian pharmaceutical policy does not allow for good facts. Given the complexities involved in pharmaceuticals and medicine, information without guidance is a dangerous thing.


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.