The Other War on Drugs
Libertarians have been stalwart opponents of the War on Drugs since its inception — a position which has brought them ridicule and scorn until relatively recently when the tide of popular opinion began to shift. Now, we see grassroots support for dozens of reforms across the states. However, the Federal Government clings to prohibition and refuses to admit that it has always been losing the war, and is now losing public approval.
Are people waking up to the principle of self-ownership, or is the change based on a simple recognition that the War on Drugs has failed? It costs too much to enforce and generally harms the very people it is intended to help.
Meanwhile, another War on Drugs receives less attention in the media, but the consequences and futility are no less grave. While Drug Enforcement Agency raids may ruin lives with spectacular flair and speed, the Food and Drug Administration’s (FDA) system of tight regulatory controls on pharmaceuticals is a silent killer.
Jessica Flanigan is a professor in the University of Richmond’s Jepson School of Leadership Studies who specializes in ethics. She says that restrictions on pharmaceuticals are some of the most unethical laws on the books. Her 2017 book, Pharmaceutical Freedom: Why Patients Have a Right to Self-Medicate, is a groundbreaking philosophical treatise against drug prohibition— just not the kind you’re used to hearing about.
Flanigan argues that the medical profession and its regulators have limited people’s access to life-saving and life-enhancing pharmaceuticals without any valid justification for doing so.
The FDA’s defenders would point to the complicated risks of medication as justification, i.e., people don’t understand their decisions. To this, Flanigan says that we allow people to make complicated risky decisions all the time — think marrying another person, or buying a car. Somehow, despite having no expertise in automobiles or interpersonal psychology, people manage to make informed decisions with knowledge of their personal preferences and the help of the marketplace, and the world goes ‘round.
While she makes some exceptions — allowing safeguards for children and incompetent adults, for example — Flanigan says that the logic behind her radical proposal is no different from that underlying the laws of informed consent. Informed consent, which became binding on physicians in the 1970s, holds that information about a diagnosis or treatment cannot be withheld from a patient, even when a doctor thinks he is acting in the best interest of a patient. As the American Medical Association puts it, “Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care.”
Against Hippocrates
Where did doctors and regulators get the idea that the people need benevolent experts to make decisions regarding the most intimate areas of their life in the first place? Look no further than the Hippocratic Oath of the 5th century BC:
““Conceal most things from the patient… Give necessary orders with cheerfulness and serenity… revealing nothing of the patient’s future or present condition.”
One would hope that the shift to informed consent heralds a broader change in public opinion that recognizes the inherent value of autonomy. Flanigan backs up her case for pharmaceutical freedom with a mixture of deontological and consequentialist arguments. That means she finds reasons to end the clampdown on pharmaceuticals based on both inherent bodily rights — i.e., self-ownership — and on the good effects or consequences that flow from such a reversal. While some die-hard libertarians might still support the “right to try” an experimental treatment that is simply poison, most see that the real world has numerous alternatives to government regulation that can guide patients to make better decisions.
Jessica Flanigan joins the show this Sunday (8/12, 8–9 am PACIFIC) to dispel common fears around deregulating pharmaceuticals — from Thalidomide babies to designer drugs that would give their users unfair advantages. Tune in live and call in with your questions: (424) BOB-SHOW
Read the Transcript
Whose Body is it Anyways?
Bob Zadek: In 1981, Richard Dreyfuss starred in a very interesting, provocative movie entitled, Whose Life Is It Any Way?. It is about time we examine that important question again. Whose life is it anyway? This morning we will discuss that question in great detail.
We are going to discuss a topic which will transcend traditional party lines. It’s a topic which both progressives, libertarians, and conservatives can find almost total agreement. We are the best suited to make decisions about our own life. Nobody knows about our life and the decisions we should make better than us. If the decisions are complicated and require specialized or technical information, in general, we know how to find that information and we are fortunate because there is so much information readily available to us either for free or for purchase. Most importantly, we ought to live our lives and set the values which govern our behavior.
I daresay that nobody could disagree with those principles. Unfortunately, there is an institution that does disagree. That institution is known as government. Specifically, we are not free to make decisions about our own health, wellbeing, and the values that drive those decisions. We are long overdue in changing that.
The regulation of pharmaceuticals, what is also known as “pharmaceutical freedom,” is an important topic of discussion and no one is better suited to lead that discussion than our guest, Dr. Jessica Flanigan. Dr. Flanigan has just published Pharmaceutical Freedom: Why Patients Have a Right to Self Medicate. Dr. Flanigan teaches ethics and related topics. She studies medical paternalism, economic freedom, leadership ethics, and public health ethics. Welcome to the show this morning, Jessica.
I think most of our listeners would believe that our country follows the core tenets of the Declaration of Independence as embodied in the Constitution, and in a couple of hundred years of common and statutory law. We think that we have primary dominion over our own bodies, and are free to make those decisions that help us. And equally importantly, we are free to make those decisions that harm us. We can decide what activities to do, what professions to adopt, to adopt a safe profession or a dangerous profession, what to buy, who to marry, whether those are bad decisions or good ones. However, that’s not as true as we would all like to believe, as you have pointed out in your book. So tell us about the big picture first. What is the issue of pharmaceutical freedom about and what is it that drove you to write this important book?
Jessica: We definitely overlook areas where the freedom over our bodies is restricted because of paternalistic public health policies by the government, and one of the largest public health organizations in America is the FDA — the Food and Drug Administration. That organization evolved over the 20th century to regulate the purchase and use of different pharmaceuticals.
They do other things as well, such as maintaining food standards like prohibiting raw milk foods and stuff. They even regulate things like dog food. They have extensive power to regulate who has access to what foods and drugs. I am focused on drugs because drugs pertain to intimate and personal bodily choices, much like other types dietary decisions, and they can have life saving potential or life changing potential. Over the course of the 20th century, the FDA slowly evolved in ways that limited people’s authority to exercise what I call the right to self-medication, or the authority to make decisions about what kinds medicines you can use.
This wasn’t always the case. In the 19th century, and even at the founding, people really affirmed the right of self-medication. For example, Thomas Jefferson once wrote in defending freedom of conscience that freedom of conscience is like self-medication. It is like our rights to make decisions about what to put in our bodies. He was kind of taking the premise that you had a decision to make a choice about your body in order to justify freedom of speech. But over the course of our historical evolution, those types of events have flipped and now we have robust protections for many rights that we didn’t have in the past, yet we lost the right to self-medication.
FDA Growth: Unseen Consequences
Bob Zadek: Jessica, just one comment if I may. You mentioned the rather recent history of the FDA and its evolution — and evolution is a buzzword for accumulation of power over us — and the dynamic is that when something bad happens to a group of people or to the country as a whole, the immediate and unpleasant reaction is that the government should do something about it.
Government should do something about it.
This implies two assumptions. Number one, that government rather than individuals is the right cure; and number two, that government, being all knowing and all powerful, even can do something about it. Both of those assumptions are wrong, but each time something bad happens, we cede more power to government and we never take it back after that bad event happens. That ratcheting effect is what allowed the FDA to grow in power.
Jessica: That is true. The history of the FDA expansion is marked by a history of drug disasters. So the original growth of the FDA happened in the 1930s after the elixir sulfanilamide disaster where children died from taking a drug that was diluted antifreeze. Then they expanded their power again in the 1960s after the thalidomide disaster. So when I talk about scaling back the authority of the FDA, people often bring up these bad events. I agree that those were horrible disasters, but there are a couple of things to know about these disasters. First, the existing framework that we have right now would not necessarily have prevented them, because thalidomide, which was used by pregnant women, was like most drugs that are used by pregnant women today in that they are still not approved by the FDA for use.
But also we don’t see the disaster that this regulation has caused. So it’s true that there is a very vivid history of drug disasters throughout the 20th century that have prompted this regulatory increase, but the people who have been killed by the regulations are invisible. They could have died waiting for drugs to be approved or because they lacked access to a prescription, or because the drug was not even invented because of this costly approval process that the FDA imposes on everybody. These invisible victims of regulation don’t get covered in the media. They don’t make the front pages the way that these large scale drug disasters do, so there is not as much political support for preventing the disaster of regulatory overreach into people’s personal decisions.
Bob Zadek: What do you mean when you say that the people who die are victims as a result of the FDA’s behavior in trying to prevent the ineffective or unsafe drugs from hitting the marketplace? How can people die as a result of that?
Jessica: Imagine that a person is a starving, but there is a market that is willing to sell them food, but out of concern for the safety of the marketplace or out of some kind of paternalistic risk aversion, a third person, let’s call him Uncle Sam, comes in and tells the starving person they are going to shut down the whole market. The person that dies from starvation is effectively killed by Uncle Sam.
If a person is dying of a terminal illness and they think that a drug could potentially beat the current standard of care, then if the drug is not approved by the FDA, the FDA can issue legal threats against the manufacturer to prevent that person from having access to the drugs.
So while it looks like people are dying of their diseases they are actually dying from the outdated and cumbersome regulatory system that prevents people from accessing the means to potentially save their own lives.
There are examples of patients who did die waiting for therapeutics that were later approved to treat their condition. That means that those people were killed, because if they had access to the drugs they could have lived longer. They are also killed by regulation in a different way which is even harder to see, which is that the regulatory system prevents manufacturers from innovating and developing as many drugs because it raises the cost of drug development. So, therefore, there could have been a range of drugs that were introduced or developed that aren’t right now, because artificially the market has this regulatory burden sitting on top of it which deters people from inventing and developing new drugs.
Informed Consent Laws Versus Self-Medication Rights: A Contradiction
Bob Zadek: What’s really strange is that here we have somebody who is unfortunately terminally ill and they are desperate. They will try anything to prolong their life expectancy. If we have a drug on the market that may work, the patient is prohibited to use it and the creator of that drug is not allowed to sell it. What is really weird is that if the patient read somewhere that eating acorns will cause cancer to subside, the patient is free to eat acorns, even though an acorn has not been proven effective at curing cancer.
The patient is denied ingesting a substance that might work, but is allowed to ingest a substance that cannot work. It is so irrational and bizarre and the whole system is born of an assumption that the government knows better what a human should or should not be doing. The human is not allowed to make an informed decision.
Informed consent, which Jessica will be discussing during our show, is denied us, even though we are informed. That is the upside-down nature of the regulation born of this government-knows-best point of view.
Jessica: We can see this really vividly when it comes to these end of life decisions where informed consent means that even if a person is facing a non-terminal illness, the patient retains the right to refuse treatment. So, a person who is diagnosed with cancer, for example, could decide not to take the drugs for religious or personal reasons. It would be illegal and morally impermissible to force somebody to accept treatment. The famous example is of the Jehovah’s Witnesses — when a simple blood transfusion could save Jehovah’s Witnesses life, but the Jehovah’s Witness maintains the right to refuse the transfusion all the same because they’re the best judge of whether or not living in accordance with their religion is more important than saving their life. The government is not.
We see this principle when it comes to those refusal decisions. You can refuse even life-saving care. But a person who is terminally ill and wants to try drugs that they think are better than the standard of care is prohibited from doing so on the grounds that it could be too dangerous, but we recognize that they retain the right to refuse any treatment at all. So there is this really stark asymmetry between the right to refuse and the right to access, where we acknowledge that paternalistically forcing people to accept treatment or forcing drugs on people would be a huge violation. However, for the same reasons that paternalistically violating informed consent would be impermissible, it should be illegal to paternalistically withhold from people access to drugs.
Amoral Incentive Structures
Bob Zadek: Everything you say is so obviously right on a moral level, and on the level of our country’s first values. We have inalienable rights to life, liberty, and the pursuit of happiness. These are core first values. What keeps this inhuman and cruel process in place? There must be people who benefit or who think it’s the right thing to do. Or, does nobody choose to change it because it has just been traditionally established for so long? What is the political dynamic that prevents a change towards the world that you propose?
Jessica: I think some of the most insidious and difficult to change governmental problems don’t happen out of malice. They just happen out of misaligned incentives. The current incentive-structure for a person who is working at the FDA is a congressional mandate, and Congress is responsive to voters. So if the FDA approves a drug that is very dangerous, and then people die because of that drug being approved, Congress goes after the FDA and will either limit the FDA’s mandates or change the FDA’s mandate, and so FDA is very sensitive to avoiding big public drug disasters that could make them look like they are not effectively doing their job. On the other hand, when people are dying because they lack access to drugs and people die of cancer because there is a cancer drug that is not yet available to them, people do not see that as a harm caused by the FDA, but rather a harm caused by cancer.
We are very focused on the kind of availability bias and these public drug disasters. Because the FDA is sensitive to what the public sees and because part of the FDA’s power issues from this kind of reputation that they’ve cultivated as the guarantors of public health, they need to maintain that reputation and that leads them to really focus on avoiding drug disasters. It makes them very risk averse. I don’t think that they are necessarily malevolent people who are trying to withhold life saving drugs so they can have control over people’s bodies or anything. I think that they are responding to the political incentives that we have set up.
This happens with a lot of regulatory agencies that have a bias in favor of addressing things that are most visibly seen. They don’t look at the cost of these regulations more generally. But I think the FDA is a particularly vivid example of how people responding to political incentives can have a detrimental effect on the whole.
Revisiting the Worth of Freedom
Bob Zadek: I have two observations after I hear your explanation. Number one is Frederic Bastiat, a journalist who wrote about economic issues brilliantly in the middle of the 19th century in France. He always reminded us to always look for the unseen. In your example, the unseen are all of the people who die quietly without headlines because of the denial of medication. They never get the headlines. The disaster — even minor disasters… semi disasters — gets the headlines. Nobody wants to show up for work and get yelled at.
The FDA has learned that by denying drugs in the marketplace they never get yelled at, so we have the principle of the unseen.
The other observation is one that I make on this show often when I have the opportunity to speak with guests such as you, Jessica, is that the throwaway is personal freedom.
Whenever there is a problem in society, personal freedom is the worthless commodity — the commodity that could be chucked away without a mere shrug of the shoulder. Government has decided we can make society so that government doesn’t get yelled at. All we have to do is chip away at freedom, and deny one more freedom forever, and then people in government won’t get yelled at. It cheapens freedom and and personal liberty to say, “let’s take away some liberty and some freedom and everything will be better.”
As you describe the dynamic, that’s exactly what has happened. As the title of your book indicates, it is trying to bring back at least one element important to freedom. Your book talks about pharmaceutical freedom, but also the bigger picture of freedom over important decisions relating to your own body. That is really the core of your book, is it not?
Jessica: That’s right. I think that the drug case is one where people’s health would be improved as well, but even if people’s health weren’t improved by exercising the right to self-medication — and surely it would not be in all case — I defend the right to use recreational drugs which don’t have medical benefit as well. That is part of freedom.
We acknowledge this in other domains. Even if marrying the person you want to marry would not make your life as it much better as marrying a different person, we still say you get to choose who to marry. Even if taking a job will make your life shorter or less happy than a different job we would still say that you have the autonomy to make that type of career decision. We acknowledge that respecting personal choice is valuable even if it would have bad consequences for the person’s life on balance. Except in health, of course.
There is this cartoon that I like — a picture of a person in a big vat of gelatin, and then there is a person in a suit in front of him and he says, “we have encased everyone in a vat of gelatin with nutrition fed directly into their mouth once a day, and the gelatin is excited to stimulate their bodies for aerobic exercise so they all live in these vats to be 150.” And then the caption says, “Fortunately, public health advocates have no legislative power.” I think that that’s pretty accurate.
Public health advocate sometimes will say things like this. But at what price? If their lives are completely micromanaged and they are living in these bubbles where they don’t have any decisions to make, what are they living for? Maybe people do not want to necessarily have really great health or really long lives. Maybe they have other values. We acknowledged that in other spheres, so why don’t we acknowledge that when it comes to health?
Self-Medication: A Natural Right?
Bob Zadek: Now, a lot of people assert they have “rights.” People claim they have a right to healthcare. They claim they have a right to live in a low rent apartment in the most expensive real estate on earth — San Francisco or in midtown Manhattan. They have a right to a good job. They have a right to eternal happiness. Of course, that cheapens the concept of a right. In the title of your book and the subtitle, “Why patients have a right to self medicate,” explain to us the source of that right and how deeply embedded it is in our humanness.
Jessica: People use the word “right” in all sorts of different ways. Sometimes people use the word “right” to mean something that would be good for you. I don’t use the word in that way. I mean “right” as a natural right. I believe that people have natural rights over their own bodies and a right to not have their body be interfered with even if it would benefit them. It is that sort of natural autonomy over our body, which is very foundational to the rest of the moral landscape, that I am talking about. And so I think that whatever we decide to do in terms of how we treat each other, how we regulate the moral landscape of permission and obligation, who can interfere with other people’s choices, etc., it should always be within that constraint of respecting people’s rights to decide what happens to their bodies.
Now, sometimes people use the word right to mean a legal right? Is it enforceable? Can the government step in to protect that? I think that’s true about self-medication. By law, we should acknowledge the fact that people have an enforceable right to decide what happens to their bodies. And the law does acknowledge that when it comes to rights of informed consent. So legally, even if a doctor lying to a person about their cancer diagnosis would make their life happier on balance, it would still be wrong for the doctor to the deceive of the patient in that way because it would violate their rights and informed consent. I’m saying that right to self-medication should also be similarly protected in the law against from interference, particularly from governmental interference.
I don’t think that the law should enable the government to violate people’s rights to make treatment decisions when it comes to access. Just like the government prohibits people from violating patients’ rights make treatment decisions when it comes to informed consent. I don’t think that rights to self-medication mean that people necessarily have a right to affordable drugs or the right that drugs be provided to them or anything like that. It’s just a right against interference. The right to self-medication is the rights against having your treatment decisions interfered with by public officials or by anybody else. But it is not a right to have effective or easy access to whatever drug you want. I don’t think people have enforceable legal rights of that kind.
Bob Zadek: In your book you tell a very short story about a patient with diabetes who consults with a physician, and the options are to control your diabetes with diet, exercise, and lifestyle changes, or manage your diabetes with insulin. That story, to me, really brought home a lot of very important issues and also highlights the utter irrationality — which really offends me — of the system we have now. Could I ask you to share that short story with our readers?
Jessica: Imagine two patients, Debbie and Danny, both of them have diabetes. For Debbie, her physician says to start insulin treatment, and Debbie understands the risks of refusing treatment but she is annoyed with the schedule and does not want to monitor her medication. So against medical advice Debbie says she is going to try diet and exercise for a while. Now, Danny is exactly the same as Debbie, but his physician says, try diet and exercise first. And Danny decides not to invest the time and energy into diet and exercise, so he goes against medical advice. He wants to try to manage his diabetes with insulin therapy. Debbie has a constitutionally protected right to refuse to have insulin forced upon her and have the right to make a very medically risky decision to try to manage her diabetes with diet and exercise instead.
Danny, on the other hand, doesn’t have a right to access insulin even if we think that the risks of their decision against medical advice is the same. So let’s not assume that one’s decision is more risky. Debbie has a right to make a medically inadvisable decision, but Danny doesn’t.
At first pass that asymmetry could just be explained by Debbie’s right of bodily integrity or her right to not have insulin forced on her, but Debbie’s rights can be violated by her physician even if a physician never touches her. For example, if the physician lies to her or tries to get her to self-administer insulin, he would still have violated her rights of informed consent.
Danny is subject to force too, you just don’t see that force because if Danny accesses insulin without a prescription, and he is doing something illegal. The laws against accepting drugs without prescriptions are coercive laws that are backed by the force of public officials. We just don’t see it that way. And so I really think these two cases are similar and that the asymmetry and how we treat informed consent and self-medication can’t be justified.
Adverse Effects of Prescription Requirements
Bob Zadek: So in the first case the patient is permitted and empowered to make a decision to skip the medication. The same patient with the same intellect and maybe a different value system makes a decision having heard both alternatives to go with the insulin and the doctor says, not so fast, I’m not going to write the prescription.
Why on earth is a patient allowed to make an informed decision one way and not the other way? Why has the doctor become a moral gatekeeper in dictating what is best for this patient’s life given this patient’s values and what this patient wants to do with his or her life? What could be more intrusive than that? The doctor’s job is to give competent, accurate information and then the decisions is the patient’s either way. The patient should be able to say, “I’ll go with the insulin, give me the prescription.” But that’s not the law. Nothing could be more irrational than that.
Jessica: It has strange consequences as well. Prescription requirements emerged in the mid-20th century just as the FDA was kind of increasing regulatory authority and as many more drugs became available to people, and you might think that this was going to like make people make safer decisions, but there’s a nice natural experiment that was done in the 1970s when some countries were picking up prescription requirements and some hadn’t, where an economist compared middle income European countries that had prescription requirements and middle-income European countries that didn’t have prescription requirements, and he found that the rates of accidental poisonings were actually higher in the places that had prescription requirements.
It turned out that that when physicians were empowered to act as gatekeepers to drugs, patients took less responsibility for their health and they would just defer to their physician, which meant that they made more risky drugs decisions because they thought that using drugs was authorized by a physician, so they had a sense that you think the drugs were safer than they were, and they didn’t really educate themselves or think about the risks and benefits of the drugs. They just deferred to the physician. So, a policy of prescription requirements which was designed to protect patients potentially made it so that the patients developed the kind of learned helplessness about their own medical decisions and actually made decisions that were less than their own self-interest than if they had been self-medicating directly.
Prescription requirements also raised the cost of accessing drugs. So people who can’t afford to pay a copay to see a doctor are shut out from accessing drugs. In some contexts, for example, like prescription cold and cough medicines in the 1980s, moving a drug to over the counter resulted in fewer hospitalizations because people just couldn’t afford to see a doctor, but they knew what drugs they needed.
Prescription requirements are one of these examples where it sounds like a good idea in theory to empower a gatekeeper, but actually it violates people’s rights and it has potentially bad consequences. Now, in other cases, giving people access to a drug without a prescription, like opiates might not have good health effects for them, but I still think that even in those cases, we don’t see the harm of the prohibition. And so even in those cases, people should be able to access those drugs without authorization.
A Role for the FDA in a World of Pharmaceutical Freedom
Bob Zadek: Now Jessica, on the subject of a right to self-medicate, expand a little bit on what it would look like if the FDA would step out of the way of what public goods we could all enjoy which we don’t enjoy now, if we had a more expansive right to self-medicate. Are we talking about a world without prescriptions, which actually is a world that I would support? Are we talking about a world with no FDA, or with the FDA with limited prescriptive powers?
Jessica: Well, in my book I say you can come with me because there many levels of pharmaceutical freedoms. I support full pharmaceutical freedom, which includes the right to purchase and use drugs for any reason, as long as there’s a competent adult patient who is informed of the risks and benefits — with the exception of antibiotics. Because I think antibiotics have externalities that can be collectively harmful. They could sort of collapse public goods like antibiotic resistance. I think rights of self-medication entail that people should have a path to access other drugs, including recreational drugs like heroin and deadly drugs like Nembutal, such that people would use for the right to die. That would be full pharmaceutical freedom.
And on that view, the FDA would still exist as a certificatory agency. It would still certify drugs and put a stamp of approval on drugs like the Good Housekeeping seal of approval. Insurance companies could let that stamp of approval inform their formulary choices and what they reimburse for. Hospitals could only carry FDA approved drugs. I’m fine with all those voluntary choices. What I am against is the FDA using the Department of Justice to prohibit and penalize people who facilitated past access for people’s self-medication choices.
Under a world of pharmaceutical freedom, people could access any drugs they wanted. They could access a full right to die, they could have a right to experimental drugs that could save their lives. They could have a right to use recreational drugs or human enhancements, like neuro-enhancement or life-extending drugs. All of that would be available freely with the right to self-medication, but the FDA could still certify and recommend drugs.The FDA wouldn’t necessarily need to be abolished. Only our using the Department of Justice to impose sanctions on drug manufacturers that would be abolished.
Bob Zadek: So the FDA’s role would have no prescriptive powers. It wouldn’t have enforcement powers. It would be, if you will, like consumer reports. It would give the public information to help the public make an informed decision about what to do. The public would be told the dangers as best they can be identified. The government wouldn’t offer the promised benefits — that would be up to the one selling the drug, but the government would provide information and in that role, I agree with you that it is the appropriate role of government to provide information because it enhances the marketplace. It makes the marketplace and a more informed place and we like that.
Jessica: I think it would be great if private organizations could also provide information. One argument is that because people don’t have medical degrees, they aren’t qualified to make these life and death decisions, but we already allow them to make life and death decisions when we allow people to stop treatment or to refuse treatment or to not take their medicine. If it’s such a complex decision medically, why would we have informed consent laws? But we recognize that we have informed consent because the medical factors are not the only relevant factors to a person’s treatment decision.
You are the expert about your whole life. Even if your doctor is the expert about medicine, and recognizing that you are the expert about your own body and your own life justifies the informed consent and self-medication with equal force.
Given that people are the experts about their lives as a whole, how can you help them? Can you help them to making the decision for them? I think that’s likely to harm them. Instead you should help them by providing them with access to information and guidance or advice about what drugs to use, and then letting them decide in light of all of that information and their personal lives, and their lives as a whole.
Bob Zadek: Does the American Medical Association have a clear majority point of view on the subject of how we handle an individual’s right to the self-medicate?
Jessica: The AMA is involved mostly with occupational licensing-type issues. I also take the stand against occupational licensing.
Bob Zadek: I have frequent shows on occupational licensing. First of all, the word license itself, i.e., permission from government, is almost an obscenity. We shouldn’t need permission from government to do anything. So as soon as you say the first syllable of license, the short hairs on the back of my neck start to stand up. So you and I are are in total agreement on that.
Jessica: I think you should be able to also make a choice to use a risky provider in the same way you should be able to make a choice to use a risky drug. On the other hand, I talk to doctors in my life and they say they don’t necessarily want to be spending all their time gatekeeping for drugs. They would like to help patients with therapeutics and get to know their patients more. The current system requires doctors to write prescriptions, which means that a lot of their time is focused on just checking a box so that a person can have access to their treatment and it’s not about building relationships with patients. I guess it depends on the reasons that you got into medicine.
The medical profession would not necessarily be harmed by people having rights to self-medication because people would still have good reason to pay to see a doctor and talk about their health options in their choices. For example, if I had full rights to self-medication, I would still talk to someone with a medical degree before making a decision just like I have full rights to make my own financial decisions but I still talk to an accountant or a financial planner. If I’m going to make a big financial decision, I would still pay for that advice. Even though legally I can do whatever I want with my property. It’s bananas that I have more rights to decide what happens to my 401k than I have over my own body.
High Costs and Regulations: The Stifling of Medical Innovation
Bob Zadek: When we discussed the FDA there’s one last point I want our audience to really appreciate. With the approval process right now in the FDA, it is very expensive to bring a new drug to market. You have pointed out in your book that as a result of that, another unseen harm is that innovative drugs never get to society because it’s too expensive to get them to market. So tell us a bit about the drugs we might never even get to experience because of the costs of getting there are too large.
Jessica: The current approval process deters innovation in a couple of ways. One is the cost. If you are a small biotech startup, for example, it’s very difficult for you to bring your drug fully to market. Now there have been some cases of patient-driven drug development, which I’ve written about elsewhere, where individual people try to develop drugs that can treat various diseases and conditions and in some cases they’ve been picked up by the NIH or drug companies and investing in this kind of basic research has led to large-scale drug gains, but it shouldn’t have to be that way. It should be the case that you can have mid-sized firms that are able to navigate the process of bringing a drug to market. And the current system also in a lot of ways stacks the deck against particularly innovative potential therapeutics.
The other is personalized medicine. The current approval process has a one-size-fits-all process. So, more personalized drugs, for example — drugs that are made out of people’s individual tumors or drugs that are custom made to respond to a particular patient type down to the level of one person with one kind of DNA in one kind of tumors — are very personalized drugs that are difficult to get approved. You need to have it approved either with the diagnostic test along with the drug and it is difficult to navigate the approval process because it’s difficult to show that the drug will be generalizable for people all considered. But currently the way that medicine is going is more personalized custom-made drugs and they’re going to have to figure out a way to enable these drugs to be developed with less regulatory burden.
Right now it’s difficult to get these custom made cancer treatments through the regulatory system. The second is about life extension or human enhancement. Therapeutics have to be approved to treat a recognized medical condition. However, having a normal life expectancy is not considered a disease.
Things that cure aging or things that give people neurological enhancement don’t get developed even though there would be a market for them because they’re not curing a disease. They are not considered a treatment when they are developed, so they’re used off-label as an enhancement. So, the current system detours innovation not only across the board by making it really costly to get a drug approved, but detours innovation in specific drugs sectors just because of the way that the regulatory environment is set up.
Bob Zadek: What we have seen and what Jessica has explained to us during this hour, is that over time, because of an isolated series of events, the power of government has grown, and therefore liberty and freedom have automatically receded and that process is never reversed. Jessica is pleading for a reversal of that process in order to give us more control and more freedom. We have also seen that the FDA is not satan. They are made up of government officials, but to a substantial degree they make their day by day decisions to benefit the institution of the FDA to the collective detriment of society. That’s not the way government ought to operate. Jessica makes a compelling case for simply returning to us the freedom over our bodies that we had at one time, and which has been taken away by incremental government intrusion into our lives.
Now, Jessica, how can we follow your writings and what are you working on now?
Jessica: First, there is hope because we prohibited alcohol once and then repealed alcohol prohibition. The doctrine of informed consent didn’t used to be a part of medicine, but today it is. When a patient protested in the 1980s for faster access to drugs, the FDA did introduce the “compassionate access” category. So there are reasons to be optimistic about pharmaceutical freedoms.
My next project is about pregnancy and childbirth and paternalism towards pregnant women in particular, which is another area where I think that government policies are limiting people’s bodily freedom in ways that not only violate rights but also have bad consequences for mothers and babies in the long run. So I have been working on that a bit, and I am also working on off-label speech, which is how the FDA censors drug advertisements.
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Links:
- Pharmaceutical Freedom: Why Patients Have a Right to Self-Medicate [2017]
- “Pharmaceutical Freedom” Jessica Flanigan, Hayek Lecture Series — YouTube (40 minutes)
- Informed Consent — Stanford Encyclopedia of Philosophy
- Libertarianism and medicine — The Washington Post, Volokh Conspiracy, Sept. 21, 2017 by Jessica Flanigan
- FDAReview.org
