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We discuss the rights of self‐​medication; rights to purchase and use unapproved treatments, prohibited drugs, and pharmaceuticals without a prescription.

This week Jessica Flanigan joins us to discuss the rights of self‐​medication; rights to purchase and use unapproved treatments, prohibited drugs, and pharmaceuticals without a prescription. As Jessica describes in her most recent publication in Cato Unbound, “For most patients, rights of self‐​medication needn’t change how they make medical decisions. After all, rights of self‐​medication do not preclude patients from consulting with physicians or using only government‐​certified drugs. But if patients had rights of self‐​medication they would be free to make intimate and personal decisions about their bodies that reflected their values rather than the values of a physician or public official.”

Further Readings/​References:



00:07 Trevor Burrus: Welcome to Free Thoughts, I’m Trevor Burrus. Joining me is Jessica Flanigan, Assistant Professor of Leadership Studies in philosophy, politics, economics and law at the University of Richmond. Her new book is Pharmaceutical Freedom: Why Patients Have a Right to Self‐​Medicate. Welcome to Free Thoughts Jess.

00:24 Jessica Flanigan: Thank you for having me.

00:26 Trevor Burrus: So there are two cases you discuss early on in the book that illustrate the central theme of the book. One of them you call risky refusal, which is, Debbie has diabetes and her physician advises her to start insulin treatment. Debbie understands the risks of refusing insulin, but is also unwilling to live by a schedule and monitor her medication. Against medical advice Debbie decides to try to manage her diabetes with diet and exercise. Debbie’s physician is morally and legally prohibited from injecting Debbie with insulin against her wishes. In the second case you call risky access. Danny has diabetes and his physician advises him to treat his condition with diet and exercise. Danny doesn’t want to invest time or energy in diet and exercise and would prefer to just begin using insulin right off. Against medical advice Danny wishes to try to manage his diabetes with insulin. However, Danny cannot legally access diabetes medication without a prescription from his physician. So how do those two scenarios set up the framework for your book?

01:24 Jessica Flanigan: The spirit of the example, what that’s intending to show is that we can just hold constant the risks. So assume that it’s equally risky to refuse to comply with medical advice either way. But in cases of informed consent we have this principle of anti‐​paternalism which says, “Even though it’s risky for you to do something that your doctor disagrees with, it’s your body it’s your choice.” But then we think about that general principle that motivates the intuition that, “Yeah, even if I’m making a risky decision, my doctor can’t lie to me. My doctor can’t force me to comply with a certain treatment.” If you have that intuition then you should also have that intuition about people who want to access drugs of comparable risk against medical advice as well. And, when it comes to the kind of refusal of care cases, we allow extraordinary amounts of risk. We allow people to refuse even life saving care.

02:19 Jessica Flanigan: So even if refusing care or refusing treatment includes a risk of death, we permit patients to make that decision to refuse life saving treatment. I think that a broad principle of anti‐​paternalism in the informed consent cases supports really sweeping rights to also make medically risky access decisions. Now, people might say those cases aren’t really analogous because in one case of informed consent, people are interfering with the boundaries of your body. Whereas in the access case, people are just withholding something that you might wanna use and there’s a kind of asymmetry there. However, you can violate a person’s right of informed consent without ever touching them. Deception for example, is a violation of the patient’s right to informed consent, but it doesn’t involve a kind of medical battery.

03:09 Jessica Flanigan: This doesn’t involve an assault upon the person in that way. Or in the access case, when people do try to access prohibited therapeutics or prohibited drugs for other reasons, or recreational drugs, deadly drugs, they are threatened with threats against their person because legal penalties consisted threats of imprisonment or threats of fines which are backed up by a kind of coercion. The intuition that there is an asymmetry between the informed consent case and the self‐​medication case, I think falls away when we see that violations of informed consent don’t have to involve coercive threats against your body, or violence against your body, and also limits on patient’s access does involve coercion and limits in this way.

04:00 Trevor Burrus: You point out that even the doctrine of informed consent, which I think everyone regards as almost obvious if you’re doctor, if you say, “I don’t want you to cut off my gangrenous foot.” And then the doctor drugs you and cuts it off anyway, people would think that that’s abhorrent but that wasn’t always the case. There were a lot of violations of informed consent 100 years ago.

04:22 Jessica Flanigan: Right. [chuckle] that’s how we got informed consent, which is… Mary [04:28] ____ about 100 years ago, or over 100 years ago went into a hospital and explicitly did not want a surgical intervention that would remove any organs or anything like that. And she not only did not consent, but she said, “Do not intervene in this way. I don’t want any kind of removal or therapeutic surgery.” She just consented to be examined under aether. And she was being examined and her physician found tumors, performed a hysterectomy. She woke up and sued the physician and the hospital, New York Hospital, saying it was kind of medical battery. And that time period was the beginning of patients having the right to at least refuse forcible interventions like that. People taking out their organs when they were under anesthesia. But in 1968, there were surveys of oncologists that were done that showed even as recently as then that 90% of oncologists would paternalistically withhold information about a cancer diagnosis from their patients, at least in some cases. Medical paternalism was the norm until really recently.

05:36 Trevor Burrus: To save them from emotional trauma or something, just to not tell them they have cancer?

05:40 Jessica Flanigan: Yeah, that was the justification, was that the knowledge that they had cancer would be an additional injury against them. However, even at the time there was survey evidence that that was not true, because people know when there’s something wrong with their [chuckle] bodies and so that kind of uncertainty that the withholding of the information induced was not in the patient’s interest either. I think part of it is that the physicians themselves felt uncomfortable delivering that kind of news.

06:12 Trevor Burrus: And I guess that’s an interesting sort of way that your book is framed that, it wasn’t always the case that we had this doctrine of informed consent that we now think is sort of obvious, but we are still practicing doctrines that prevent people from medicating themselves, which hopefully will one day become as obvious, that it was absolutely inhuman to prevent people from accessing medications of various sorts. And in that, you just kind of make a very clear philosophical argument, which I’d like to work through premise by premise. Your first premise is each patient is typically in the best position to determine which treatments are in his or her overall interest. Is that really always true?

06:54 Jessica Flanigan: No, of course not. [laughter] We can… I say, typically or in general people are gonna be experts about their own interest. And that’s just to say that maybe a physician knows what’s medically best for you, which that’s… That’s not always the case, but say that physicians are medical experts, health is only one value and how that value of health fits into the patch work of your other values, how it informs your choices in your life more broadly, that’s something that you are the expert about, that only you can really know for you, from the inside of living your life. How important is it for you to make these trade offs regarding, for example, longer life versus higher quality of life? How important is health relative to cost or convenience. And informed consent recognizes that. That’s why people are allowed to refuse life saving treatment, even if it’s in their medical interest because people might say, for example, it’s more important to live in accordance with my religion than it is to get a blood transfusion that could save my life.

08:00 Jessica Flanigan: And we say, it’s your body. You know how living in accordance your religion fits into your value system relative to how health fits into your value system. There’s a principal of deference. Even if people in general are the most qualified to make these judgements, of course there are gonna be a counter example cases where you can see a person, you’re like, “Oh my gosh, that person’s like… ” Even by their own lights they should see that they’re making a terrible choice. I think that we’ve all known people or seen people where we were like, “Oh, why are you dating that person? That’s not in your interest,” [laughter] or something like that.


08:37 Jessica Flanigan: But then the question is, who would be better? Even if we can see that people are generally making reliably bad choices for their life, it doesn’t follow from that that there’s a general principle that like other people in their lives who occupy a certain institutional role are gonna reliably do much better. Pointing to one off examples where people don’t promote their own overall interest doesn’t establish that there shouldn’t be a general presumption in favor deferring people as the experts on their own interest.

09:09 Jessica Flanigan: And what about those who are, say, addicted to very powerful substances? Do they know what’s in their overall interest?

09:17 Jessica Flanigan: Addictive drugs are a more difficult case for the… We may call it the epistemic argument, the, “you know what’s best for your overall interest” argument. Because it’s controversial in the philosophy of addiction, the extent to which addictional choices are voluntary. But I tend to be pretty persuaded that even addictive choices are choices that are sensitive to reasons and incentives and that that is a decision that a person’s making. Yes, in light of an extremely strong addictive desire. Given that they have that addictive desire, I do think that they’re still consenting in those choices. So on the rights based argument, which I imagine we’ll get to later, I do think that addictive decisions merit respect. On the other hand, on the interest based argument, which is what we’re on right now, which is this kind of you’re the best judge of what’s good for you on balance. Sometimes people will have really strong short term desires that might prevent their ability to promote their long term desires. But I do think even then you should still preserve a principle of deference even for people who are addicted. Although I will concede that that argument is, I think less strong than the rights based argument here.

10:34 Jessica Flanigan: And the reason is partly because of what I said earlier, which is even if a person isn’t as good at trading the day for the year, even if they are more sensitive to extremely salient, powerful short term desires relative to long term desires, for example, it doesn’t follow that somebody else, [chuckle] would be better making at those types of discussions for that person. And I’m also… It doesn’t follow that… I also am skeptical that it follows that having a prohibition is the best way of helping that person act in accordance with their interests. If all we’re just thinking is the welfare on balance of people who are addicted to drugs, who are making the decision to use drugs, I think giving them information about treatment alternatives or access to things like Suboxone, and giving them the resources to make different choices that could be more in their long term interest, is a more humane approach than the kind of prohibitionist approach. Especially when you’re thinking of addictive drugs which are classified as recreational drugs more, because then people… The way that we respond to that as a society, is not only by preventing them from accessing it, but by criminalizing it.

11:49 Jessica Flanigan: And I don’t think anybody should think that it’s in the interest of addicts to be subjected to criminal penalties for failing to promote their interest. Whether or not a person’s promoting their interest, I don’t think that it would be in their interest more generally to subject them to criminal penalties when they fail to.

12:05 Trevor Burrus: To go to jail, yes. Well, Jeff Sessions, I think believes that, but I think fewer and fewer people believe that. So the next premise, this is for the informed consent premise, health workers should aim to promote patient’s overall well being, which seems relatively non‐​controversial. And so the third premise is, in general, the most reliable way to promote overall well being is to defer to the expert who, as you’ve argued before, is the patient. And so the conclusion is health workers should defer to patients judgments about treatment options and that you argue should applies across the board into prohibited, what are currently prohibited, drugs. So getting into that, what does the FDA do regarding access to pharmaceuticals?

12:47 Jessica Flanigan: So there’s three ways that patients rights to access drugs are currently limited. The first is, some drugs you just can’t buy them. You can’t get ‘em. So they’re prohibited drugs. So in some states, for example, drugs that people could use just to end their lives, those would be prohibited, like Nembutal or something. So there’s prohibitions on certain drugs, recreational drugs, prohibited through the DEA or the Department of Justice more generally. There’s also these more subtle ways that people lack access to drugs, which is more through the FDA, which I think are often overlooked when we’re talking about drug policy because it’s… Some people do in fact have access, but it’s partial distribution of access. And the two that I focus on is first the approval process. So while the approval process is happening, which take years, only patients that are accessing the drugs through the context of a clinical trial or more, very rarely through a Compassionate Access program, but just, for the most part, clinical trials, only people who are enrolled in the clinical trials for the testing phase of the drug have access to that drug. So then, people who don’t qualify for inclusion in the trials that are part of the approval process are left waiting for the drug.

14:10 Jessica Flanigan: So imagine that a drug is going through this approval process to be tested for whether it’s effective. That means that the only people who have access to it are patients who meet the patient type condition combination to qualify for inclusion in the trial. But once the drug is approved, patients with all sorts of conditions might benefit from using the drug despite the fact that the drug wasn’t tested for efficacy for their condition. And so all of those additional benefits that patients can get from using a drug or accessing a drug are forestalled while people lack access during that lengthy clinical trial phase. And I think that it has bad effects in two ways. The first way is just that people suffer and die waiting for access to a drug that could potentially benefit them and that they judge could potentially benefit them because they can’t qualify to participate in the approval process. The second is the approval process is so long and so expensive that it deters innovation. And so the first thing that just people who suffer and die waiting for approval, that’s called drug lag, and that’s bad because there’s lives lost for a drug that exists, and you can, in some ways, see the human cost of that. So you can see examples of patients who wanted to access a drug, didn’t meet the criteria, died.

15:36 Jessica Flanigan: Later, the drug is approved and used off label to treat the condition that they had. What we never really see are the people who are suffering or dying of conditions that could have been treated, but we had such a costly approval process that we deterred innovation in a way that we don’t even see the drugs that could have been developed had we had a system that was less burdensome with regards to drug development and we could have a more innovative system, and that’s called drug loss. And that kind of lack of innovation is also really costly. Also, the FDA designates some drugs as requiring prescriptions, which means that physicians are legally empowered to act as gatekeepers between patients and their drugs. And this is where the patient’s know best argument might be seen pretty vividly because, for example, you could imagine a patient who says, “I think it’s in my overall interest to use”, for example, “Adderall” or something. And I think there should…

16:34 Trevor Burrus: Which a lot of people do think that, yes.

16:36 Jessica Flanigan: Yeah. [chuckle] Right, and if their physician judges that it’s not in their medical interest, then the physician is legally empowered to override the patient’s judgment about what’s in their interest, and then the patient lacks effective legal access to the drug. So by empowering physicians to act as gatekeepers through this prescription system, the FDA is effectively empowering physicians to override the patient’s judgement about what’s in their overall interest.

17:05 Trevor Burrus: Now as the FDA… It’s always struck me as odd that the FDA determines how risky some things should be, but they haven’t always done it this way, correct? It was only since about the ‘60s that they did this efficacy type where they decide if the drug is effective enough for the FDA, which is strange ’cause that’s not really the question. If the FDA was deciding if hang gliding was effective enough for me or risky enough for me, I don’t really know how they could make that decision, and it seems to be the same with drugs. What do they actually purport to do to decide how risky it should be?

17:42 Jessica Flanigan: Yeah. So both safety and efficacy are not scientific judgments. The FDA is like, “Oh, we’re just deferring to scientific judgments about safety and efficacy”. But there’s really no such thing about a scientific judgement [chuckle] of safety and efficacy.

18:00 Jessica Flanigan: So safety is maybe a more universal idea, like on balance, is this more likely to make things better or worse, or something like that. But efficacy, is it effective at treating this? The standard isn’t necessarily does it treat it at all, but does it beat the standard of care, or does the drug benefit the patient with that condition sufficiently such that the benefits are worth it, given the side effects and risks. But notice that if you’re looking at a drug, or you’re looking at a trial population, you’re looking at the results of the trial, there’s nowhere under the microscope or in the spreadsheet where you can identify the property of acceptably risky, or you can identify the property of worth the risk. So, these aren’t medical judgements, they’re not scientific judgements that they’re making. They’re making it on the basis of medical and scientific data. But, patients could also make a judgement about whether or not something’s acceptably risky, or worth it, based on that evidence. And, based on a bunch of evidence that every patient has, which would be totally inaccessible to public officials, which is evidence about their values, about their life, or how they trade off side effects versus longer life, or how they tolerate risk, like people have different tolerances for risk. So, given that people are all so different, it’s odd that the efficacy standard and safety standards require a kind of one‐​size‐​fits‐​all judgement.

19:40 Trevor Burrus: I think people would probably say that this makes some sense in the abstract, but we’re really talking about questions that patients can’t answer. It’s not… They can’t read, I don’t know, the chemical composition or something, or get an idea of how this works, or understand all the arcane medical terminology and all this stuff, and they’re also super vulnerable as people with possibly, let’s say, terminal illnesses, so they’re willing to… If they went to a witch doctor who said that they could cure them with crystals or some sort of rain dance, they would do that, too, and you want to say, “Yeah, you probably shouldn’t do that.” And maybe… Standing in between those people wasting time and money and endangering their lives seems like an important role of the state.

20:24 Jessica Flanigan: Well, this kind of gets to the second class of arguments, which is just more generally against paternalism. So it is true that people who are suffering from these illnesses are potentially more vulnerable, we might think, because we see them making decisions that wouldn’t make sense to us, like, “Oh, I can’t believe you’re spending so much money on this therapy that doesn’t seem likely to work,” but it’s hard for us to make that judgment without knowing what’s in their head and… People who are in that type of a situation might make judgments that look like they don’t make sense to us from the outside, but we from the outside really lack access to understanding what it’s like from the inside for that patient. And it might actually be a rational decision. But even if it’s not, it’s still their bodily choice to make. And so, people with terminal illnesses sometimes might refuse treatment, and you might think… Or, maybe not terminal illness, let’s deal with degenerative illnesses, for example. And you might think, “Oh, my gosh, this is an irrational decision. If you accepted treatment, you could have five more good years,” or something like that.

21:37 Jessica Flanigan: And a person might nevertheless say, “Yeah, I agree that I might have all this wellbeing in the future.” But nevertheless, they could decide reasonably to refuse treatment. And even if they’re in some ways closing themselves off from a bunch of wellbeing gains in the future, they’re still exercising their rights. It sounds like kind of what part of your question was getting at, though, is people are just not qualified to make complex medical decisions about drugs because drugs are so complicated and there’s a lot of science involved, but that’s also true of refusal decisions, because if you’re refusing a therapy, then in order to make an informed decision, you should know about the drug that you’re refusing, [chuckle] and so, it would cut both ways. And also people can sign mortgages, people make a bunch of other complex decisions. And I’m not saying that people shouldn’t defer to experts in general. So for example, if you think that patients are generally ignorant and that people are vulnerable to be misled or exploited especially if they have terminal or degenerative illnesses, I’m not saying that people shouldn’t talk to their doctor, talk to medical experts, talk to people who know a lot about science. And I even think that the FDA, if they wanted to, could certify drugs that people still have a path to access.

22:48 Jessica Flanigan: And so, if the FDA just certified a drug and said, “Our judgment is that this drug’s not worth it for the treatment of breast cancer,” which they did, for example, like Avastin. “Our judgment is that people shouldn’t use this drug for this condition.” Patients should have, I think, access to that kind of information, that information should be communicated to them in a way that’s clear and understandable by their physicians. They should have an opportunity to ask questions of pharmacists, for example. So if you’re worried about patient ignorance, I’m saying there’s a kind of ignorance that we should worry about on the side of the doctor and the regulator, which is ignorance about what it’s like to be that patient, and there’s a cure for the patient ignorance, which is that the patient can talk to the doctor and they can look at certifying bodies and see if a drug is certified for their condition.

23:35 Trevor Burrus: So, it’s really about this, as you pointed out earlier, that you’re not advocating for burning the whole thing down, or at least not in this book, but that there’s, “Let’s think differently about ways of doing this.” And the big problem here is the prohibition of access. If it’s just, as you said, certification, hey, the FDA has spoken and people believe the FDA and they trust it and other things, we could do this better than the way that we’re doing it.

24:01 Jessica Flanigan: Exactly, yes. If people think that the FDA is a really reliable judge of whether or not it’s worth it for a patient to use a drug with certain conditions, then let them be the judge, let them certify drugs. And I’m even open to private insurers could say, “We’ll only reimburse for FDA‐​certified drugs.” That’s a fine choice. If a private company thinks that it’s only worth it for them to pay for drugs that have a certain kind of certification, that’s their business. So you could even incentivize people to follow what the FDA is saying, but the current system treats people in a way that I think is sort of disrespectful of their own authority to make decisions about their life, and it sort of misses out on all of the information that you get from deferring to people’s judgments about what’s good for them.

24:50 Trevor Burrus: You discuss a classic philosophical example in the book that comes from John Stuart Mill, though, which touches on this. Is it permissible to stop someone from unknowingly crossing a dangerous bridge? So to act, even with coercion or to just stop them, which seems kinda paternalistic, so is that okay? Is that analogous to what we’re talking about here?

25:13 Jessica Flanigan: Well, yeah, just in the first instance of that, I would say wouldn’t it be better instead of tackling a person if you could, if you could just instead call out to them and say like, “Hey, that’s a bad choice.”

25:24 Trevor Burrus: [chuckle] Yes.

25:25 Jessica Flanigan: And so if the FDA wants to call out to people and say, “Hey, that’s a bad choice,” they can. And I think it’d be great for them to do so.

25:35 Trevor Burrus: But if they continue to go to the bridge…

25:36 Jessica Flanigan: And then… If the bridge‐​crosser hears that and is still saying, “Yeah, I think it’s worth it,” I don’t think that you could coercively interfere with the person.

25:46 Trevor Burrus: So, that leaves my next question, then. So, it seems to imply that is it ever okay to… Or when is it okay to stop someone from committing suicide?

25:55 Jessica Flanigan: Yeah. So in the book, I say that people should have a right to die. And part of it is that people have the right to refuse life‐​saving treatment, and I think it’s kind of morally arbitrary to say that you have a right to make a deadly decision by refusing life‐​saving treatment. And also, people die via terminal sedation when their… They can consent to be sedated until they die. And so, it’s odd that people can refuse life‐​saving treatment, and they can consent to terminal sedation, but they can’t consent to deadly treatment and have a right to die. It’s difficult in some cases because I do think that it’s possible for a person to lack the capacity to make that kind of a decision. And so you’d want to have some kind of ability… Or some kind of, in principle, ability to know that. But I think in general, there should be an extremely strong presumption in favor of having the right to die because I think that yeah, people have the authority to make decisions about their bodies, even that end their lives. And so we can talk a little bit about sort of whether or not people have a moral obligation not to end their lives in certain cases, like if family members rely on them or something. But… Yeah, I think there should be a pretty broad access to deadly drugs, even.

27:25 Trevor Burrus: So if I walked into my house and saw that my roommate was getting ready to hang himself, or maybe he was currently swinging, would it make sense for me pick him up and try and resuscitate him? Or should I say, “No, no, it’s okay. He made a valid decision”?

27:47 Jessica Flanigan: It’s difficult to know about the capacity, but I’m imagining this case the way that you’re describing it, where it’s a case of a person who has, for example, treatment‐​resistant, clinical depression or something like that. And I do think that there should be a path for a right to die for people who have this, so, maybe it would make sense in that case to intervene. But that’s not to say that just because in that case, it may make sense to intervene and I think it could be good to rescue him from that, that the right to die should be foreclosed, even for people with treatment‐​resistant depression. So for example, Belgium has a system where people can access deadly drugs, even if they have depression. And Switzerland has a system where once they have these checks in place to ensure voluntariness and competence and a lack of coercion, people can access deadly drugs even out of weariness of life or… Yeah, because sometimes people will access the Right to Die and Suicide Clinics, because they’re partners, they’ve lost their partners, or they’re going to lose their partners, and those are all non‐​medical reasons that people end their lives. And I do think that that should all be legally permissible. Now, I don’t think that that means that deadly drugs should be sold…

29:13 Trevor Burrus: Out of vending machines?

29:15 Jessica Flanigan: Yeah, right.


29:15 Jessica Flanigan: I think behind the counter. So right now in order to get Sudafed, you have to get behind the counter, and there’s a sort of age requirement check and some kind of capacity check by a health worker, I think would be warranted for the case of deadly drugs. Not paternalistically, not to try to talk people out of their choices per se or anything like that, but just to ensure that the person really is acting with capacity, that they’re voluntary, that they’re not acting in light of coercion. For example… So, I think that people do have a moral right to use deadly drugs whatever their reasons are, but there might be some pragmatic reasons to have additional limits on [chuckle] the access. The Swiss system or the Belgian system might be a better approach to accessing deadly drugs. But also you wanna think about the counterfactual. So when I say that people have rights to access deadly drugs, yeah, people, counterfactually, given that they don’t have a right to access deadly drugs, does that mean that if people had a right to access deadly drugs that the suicide rate would go higher? I don’t think so. I just think that maybe there would be more checks on capacity, but we already have a system where people can access guns or…

30:45 Trevor Burrus: Bridges or buildings.

30:46 Jessica Flanigan: Right, exactly. And so, by saying that, yeah, I think people have a right to access deadly drugs, it doesn’t necessarily endorse that choice. I think it could often be a very bad choice, it’s just says that it’s within a person’s rights. People have the right to do all sorts of things that they shouldn’t do.

31:09 Trevor Burrus: [chuckle] Now, of course, if you’re gonna defend accessing just straight‐​up deadly drugs, as you pointed out, and clearly it would seem to imply that just drug prohibition of recreational drugs is not allowed, either, if people are going to just enjoy themselves on these drugs.

31:25 Jessica Flanigan: Right. [chuckle]

31:27 Trevor Burrus: How much of that is contingent upon the nature of the drug? Because we could talk about the right to put something into your own body, but if you think about the drug that only makes you eat faces, that’s all it does, that’s the bath salts, which is a myth by itself with the zombie‐​eating guy in Florida. That guy was not on bath salts; he was on a small amount of marijuana, and he was crazy. But let’s imagine the face‐​eating drug that people want to take, which would make me suspicious of that person to begin with, but is that the kind of drug that should be illegal? Or something that is really, really dangerous to other people if someone ingests it, like many people believe PCP is, which it’s not terribly? But some of those drug stories that you become a psychopath and punch everyone in the face and an unkillable hulk, should those kind of drugs be illegal?

32:19 Jessica Flanigan: No. I think that… [chuckle] That’s so funny, so, I think face‐​eating should be illegal…

32:26 Trevor Burrus: Yes. I agree with that. Yes. Let’s go out on a limb there, yeah.

32:31 Jessica Flanigan: I’m gonna come out and take a stand in favor prohibition for face‐​eating, but not prohibition of the drugs. We know of a drug that causes people to commit acts of violence at a higher rate or to put other people’s lives at risk, and it’s alcohol. So, we have that drug and we tried prohibiting it, and it was a disaster, and we should learn from that lesson, that if you think that it makes sense to prohibit a drug because it incites people to act in ways that are impermissible, instead, you should just prohibit the thing that impermissible. So don’t ban alcohol because it leads to domestic violence; enforce policies that protect people from domestic violence, [chuckle] whether or not their husbands are drunk.

33:17 Jessica Flanigan: And sometimes people will say this in terms of drug prohibition, where they’ll say, “Well, if a person’s a hardcore drug user, then they’ll be more violent, or they’ll neglect their family, or they’ll steal from people. They’ll steal your TV to get drug money.” Well, prohibit the wrongful acts that they do for the sake of the drugs. Don’t… Because it’s possible for a person to be a drug user of any kind of drug and to not commit those wrongful acts, and if a person’s a permissible drug user… So say that there’s the face‐​eating drug and it gives a person extraordinary pleasure, but it makes someone eat faces. But some people take the face‐​eating drug, we’ll call it werewolf style where they lock themselves in a cage on the full moon and then they just use the face‐​eating drug but they can’t get out of the cage.


34:02 Jessica Flanigan: Okay, that’s their business if they wanna do that, [chuckle] and you shouldn’t prohibit those people just because a bunch of other people are gonna use the face‐​eating drug in a bad way any more that you should prohibit alcohol because some alcoholic people commit domestic violence. That wouldn’t be a reason to say that nobody can have a glass of wine at night.

34:21 Trevor Burrus: Well, I think for some people, it’s an interesting question because as I try to… How far you’re willing to go, because alcohol does have, as you pointed out, extremely negative effects on violence and violence can go down if you prohibit alcohol, which could increase… Keep people alive, increase the people who aren’t now dead or harmed, increase their rights, their right to autonomy. The total amount of autonomy could go up, because on some studies, alcohol is implicated in 30% to 40% of violent crime in some way, so it would be a total autonomy, rights‐​maximizing thing to prohibit alcohol if we could do it effectively.

35:04 Jessica Flanigan: There, which is, one is we can’t do it effectively, and subjecting people who are doing something, even that’s really risky or dangerous to preemptive criminal penalties has all of these bad backfire effects where it could be disproportionately enforced, and it could lead to black markets and low quality. All the stuff that we saw during prohibition, all these kinda instrumental worries. But also I don’t think that we should be autonomy maximizers. I think autonomy is important, but that you should respect autonomy and not maximize it. And the reason is I don’t think that people who use alcohol in a permissible way are liable to be threatened with criminal penalties because they haven’t done anything wrong. It’s not wrong to engage in self‐​regarding behavior like that. You’re making a self‐​regarding decision about your own body to use alcohol. And so you’re not doing anything wrong. You don’t make yourself liable to be interfered with just on the grounds of some other alcohol users are going to misuse it. So there’s an analogy here with gun ownership.

36:16 Trevor Burrus: Yep. That’s what I was gonna ask next. Yes.


36:20 Trevor Burrus: Seems very similar that the law‐​abiding people shouldn’t be punished for the non‐​law‐​abiding people.

36:27 Jessica Flanigan: Right. The thing that you should prohibit effectively is violence, but just making that permissible, self‐​regarding decision doesn’t make you liable to be subjected to criminal penalties.

36:40 Trevor Burrus: You do bring up in the book, I’m glad when I was reading it ’cause at one thing I… When I saw the cover and I saw what it was about, I said, “Well, she needs to talk about antibiotics.” Because as we’re well aware… Or we should be well aware that there’s an increasing fear and danger of extremely resistant bacteria, which there’s some extreme doom‐​sayers on this, who say it could be like going back to pre‐​penicillin days, which is the most probably important drug ever invented, and antibiotics in general, make even surgery possible. So, you think differently about antibiotics, that they actually should be restricted?

37:16 Jessica Flanigan: Yes, I do. And here again, the analogy to informed consent is useful. So, I… In general, all of us, we all have a right to refuse treatment, to say no to certain medical interventions. But that right doesn’t entitle us to inflict harm upon the rest of the community. So, I think that the right of informed consent doesn’t protect people necessarily from some kinds of compulsory vaccination policies. So policies that would say anybody who’s using public services, anybody who’s working in a public‐​oriented job, for example, should be compelled because they’re gonna be interacting with the public or being in public in this way, to be vaccinated. And compulsory vaccination, I think, is justified because you don’t have a right to weaponize your body by spitting whooping cough on your fellow citizens any more than you have a right to go out on your back porch on the 4th of July because you love gun rights or whatever and you wanna celebrate with your gun, and fire your shotgun into the air where it could potentially harm your neighbors.

38:24 Jessica Flanigan: So that’s a kind of harm to other’s limit on your right to make medical decisions about your own body, which even applies to informed consent. Similarly, with self‐​medication, sometimes people’s self‐​medication choices will subject other people to a higher risk of harm, and there’s limits to self‐​medication when your medication choices are intrinsically harmful to other people. So it’s not like the PCP face‐​eating case, [chuckle] where there’s sort of like… There it’s a correlation, it’s like… No, using this in principle is gonna raise the risk of contagious transmission, in the vaccine case, or in resistance, harmful resistance, in the antibiotic case.

39:06 Trevor Burrus: Are there limits on the vaccine question of… There’s a lot of vaccines out there for different diseases, and you could mandate that people get 80 to 100 vaccines, as opposed to, kind of, five or seven of extremely dangerous and highly communicable diseases. What are the limits to the mandating of vaccines you’ve discussed?

39:30 Jessica Flanigan: Yeah, and so once we’re in this sort of territory where we’re weighing harm to others against a person’s own bodily autonomy or bodily integrity, then you just really have to look at the force of the reasons on these sides of like, how strong is the person’s entitlement not to be harmed relative to how strong is the person’s entitlement to make this decision. But in principle, there could be a level of antibiotic resistance risk or a vaccine risk that would justify requiring vaccination or requiring people to get a prescription for antibiotic use. So I’m not saying that it’s always justified. For example, I don’t think that a tetanus vaccine could ever be compulsory because there’s no risk of contagious transmission, so… But the sort of exception carved out for antibiotics is similar to the exception carved out for vaccines, which is, depending on the level of the risk of harm to others imposed by that choice, it is in principle possible that it could be permissible to limit bodily rights in those cases.

40:34 Trevor Burrus: So there’s a interesting weighing here, as I think you’ve articulated, that this is a… You have a presumption of use, presumption for use of deadly drugs, of being allowed to use deadly drugs, a presumption to use harmful substances or addictive substances, presumption to use possibly life‐​saving things, but in many cases, they can be defeated by countervailing facts and specific…

41:00 Jessica Flanigan: Right, by the rights of other people. But other people don’t have a right that you don’t harm yourself. Other people have the right that you don’t harm them. And so it’s like the anti‐​paternalistic presumption. You can’t defeat that presumption by being like, “But it’s gonna be really good for us to interfere with you for your own sake.” But you can… Other peoples can have a claim that you not do it.

41:22 Trevor Burrus: On the paternalism point, one thing I hadn’t asked yet was, what about the difference between, and you discussed in the book, between stated judgements, people’s… People, what they want now, but versus their considered judgment. The section there reminded me somewhat of the nudge question, that you could ask someone, “Do you wanna lose weight?” and they could say, “Yes,” but then… Or they could say, “No,” then they’re considered, or they could say yes and so you hold them to one judgment over the other. Should we prefer considered judgments over just what people say that they want?

41:58 Jessica Flanigan: Well, I do think people should be encouraged to reflect about what their judgments are, right? But I think that there’s a danger sometimes where we think like, “Oh, we don’t care about a person’s initial judgment, we care about the best version of what you would decide.” But if you’ll keep on idealizing away from the best version of what a person would decide, you become increasingly distant from the person’s actual values, judgments, and experiences. And so we could just keep on idealizing, sort of all the way up and say, “Well, if you’re fully informed and fully rational, you would make the decision that’s in your best interest,” and you have a justification for paternalism.

42:39 Jessica Flanigan: And so I don’t think that you should do that because I think that if a person were fully informed and rational, it’s hard for us to even say why that kind of idealized judgment should have any authority for the person who’s actually existing in the world making the judgements they’re making. And there’s no real intermediate level of idealization of how good of a decider you would be to justify stopping short, short of full idealization, of full information, and full rationality. So that’s one thing, which is like… I think it’s difficult to kind of appeal to what you would’ve decided type arguments in justifying paternalistic interferences with people without just saying straight up, “We’re gonna impose on you our judgment of what we think is gonna be best, all things considered real.”

43:37 Jessica Flanigan: But I also think people might have a considered judgment at the second order level, that they want the discretion within their lives to make not‐​so‐​considered choices at the first order level. So for example, [chuckle] it’s really costly to gather information. It’s costly to research stuff. And so people might just say, “You know, the cost of gathering a different… More information or deliberating about this so much is like not that worth it for me. I’m good. I’m just gonna do what my doctor tells me.” Or, “I’m just gonna do what’s cheapest,” or whatever, and they’re just not gonna think about it that much. And I don’t think that we have a good reason to think that we should value a person’s considered judgment in particular cases versus her considered judgment, that she just wants to have a space of autonomy to make sort of quick judgments in smaller cases, and more discreet cases, I guess.

44:29 Trevor Burrus: It does seem like you get pretty quickly, too, ’cause you could say, “Well, a person fully‐​informed and considered in their judgments would not eat, say, raw beef, and therefore we’re going to prohibit you from eating raw beef, even though you say you wanna eat raw beef now.” Or a person, with their fully‐​informed or considered judgment who has, say, terminal cancer would not take this possibly life‐​saving drug, but that is still risky. And that just basically says… It leads to saying that the FDA is the one making those fully‐​informed and considered judgments for you which, as we said, is problematic. Now, when it comes to…

45:05 Jessica Flanigan: Yeah, it has weird extensions. This is like, it’s hard to know how to even do the idealization ’cause it’s like, imagine a Jehovah’s Witness person, and you’re thinking like, “Well, what would you think if you were fully informed, fully rational, you had all the facts, and you really knew the truth.”

45:19 Trevor Burrus: Then would, you wouldn’t be a Jehovah’s Witness. [chuckle]

45:21 Jessica Flanigan: And you had, you’ve in fact done it, and you’re like, “You know what? You would know that God actually doesn’t prohibit this.”

45:25 Trevor Burrus: That’s what it implies, yeah.

45:28 Jessica Flanigan: And so then… [laughter] And you’re just like intervening with that person.

45:29 Trevor Burrus: Yeah. Implies that you wouldn’t believe what you believe, you would stop… You would give up your religion and all these horribly paternalistic things. When it comes to the life‐​saving drugs, though, I think that the possibility of clinical trials issue is what the government has argued at different times, when they said that, “If we let everyone try a possibly life‐​saving drug to… That they… ” For terminal head and neck cancer, for example, to use an pointed example of the Abigail Alliance case, then we would be unable to find people to do a clinical trial where we have a control and a placebo, and we have the drug. So we won’t even be able to tell if the drug is efficacious. And that argument that the FDA has made has carried the day in the courts, and a lot of economists and health professionals agree with that. But you’d think that that’s not a good argument, either.

46:24 Jessica Flanigan: Yeah. Well, first of all, this is assuming a backdrop where you can’t incentivize people to participate in trials, for example, by paying them. So call this the kind of like, “need to test” argument. We need to withhold access in order to give people good reason to participate in a trial. But that’s assuming that the only way that you could give a person good reason to participate in a trial was by giving them access to this drug. But if that were true, that would be… That would make me have a concern about the trial design itself, because I think that in order for a trial to be ethically designed in the first place, you would want it to be the case that you’re genuinely uncertain about whether or not the tested drug is better than the existing standard of care. And so, you wanna have a kind of principle of clinical equipoise.

47:15 Jessica Flanigan: And so if you have this principle, which is that, going into a trial, there should be a kind of genuine chance that this does or doesn’t beat the standard of care, then patients should have a rational reason to participate in the trial either way. You would think, “Well, they have the standard care, they have the trial participation.” So if you could… Especially if you could give them incentives, paying people to participate in trials for example, or other benefits, like subsidized medical care or more careful monitoring, people should still have an incentive to participate in clinical trials. And if you think that on balance, participating in the clinical trial would be worse than the standard of care for a patient, well, that’s a difficult practice to justify for the existing clinical trial framework. [chuckle]

48:02 Jessica Flanigan: If these people who are participating in the trial are being subjected this treatment which is worse than the standard of care. I mean, of course, they could consent to it, but then if you think, “Oh, people can consent to any risk for the trial in this way, then you can just pay them to do it that way as well.” So if we are gonna hold trials to that kind of standard, then I think that people should have sufficient incentive to want to participate. Then the counter worry is, well, maybe too many people would wanna participate because people would just be rushing into the trial ’cause they had all… Or not rushing into the trial, they’d be rushing to get the drug because they wouldn’t have to participate in the trial, they would just access the drug outside of the trial.

48:39 Jessica Flanigan: But if we think that the drug is so good that people are all gonna wanna access it outside of the context of a clinical trial even if they could get paid or get subsidized medical care or more careful monitoring by participating in a trial, that should also make us a little bit worried about how the trial is currently functioning. Because if there is this drug out there that really clearly beats the standard of care so much so that patients are flocking to use this investigational therapy, then that also indicates that maybe the trial design wasn’t meeting this kind of condition of equipoise already, and so that people should have been… An existing trial should be moving more people into the treatment arm of those trials.

49:17 Jessica Flanigan: But also, I just don’t think that more generally that efficacy testing requirements are necessary for researchers to learn about new drugs, and we can see this because we still have clinical trials that happen for drugs once a drug is approved for one condition and off‐​label so we still see testing for drugs even after this initial approval trial. So a lot of clinical trials today happen after approval, so people can have access to the drug that is being tested for them, but they still participate in the trial all the same.

49:54 Jessica Flanigan: And so, I give in the book a couple of examples like this, like one with the Women’s Health Initiative of a post‐​market trial that was still testing efficacy even though efficacy… Or even though the drug was available off‐​label outside of the context of a trial. So I think there’s a lot of reasons to be skeptical of this “need to test” argument. But also, I think even if this were true, it wouldn’t be justifiable to violate people’s rights so that you could get good data about medical information.

50:25 Trevor Burrus: Yeah, that seems often like a… Yeah. You can’t do human… Violate human rights on subjects to try and get medical data, either…

50:35 Jessica Flanigan: Exactly.

50:37 Trevor Burrus: Like the Nazis did. So it seems like that that’s a bad way of using humans.

50:40 Jessica Flanigan: Yeah, so [50:40] ____ is a bioethicist who’s worked on HIV/AIDS access, for example. He makes this point, which is like, “Look, even if there were really serious externalities to giving people access to potentially life‐​saving experimental drugs, like investigational therapies, even if that had like… It made it really difficult to conduct research, even if it was in some ways undermining trial design, the people who are making a claim to access these drugs are making a claim to preserve their own lives. And so it’s very rarely the case that you can violate a person’s right of self‐​defense [chuckle] for example, in these types of cases for the sake of scientific knowledge more generally. If a person has a defensive right, that has a lot of moral force. And I also think that’s true not just for defensive rights to preserve a person’s life, but defensive rights more generally to preserve a person’s health.

51:37 Trevor Burrus: Now we’re recording this on May 31st, 2018, and yesterday President Trump signed a right‐​to‐​try law, which purports to adjust some of these problems. And for a while now, there have been calls for freeing up access for terminally ill people. It happened in the ‘80s with AIDS patients. It’s happened over different times. That right‐​to‐​try law, I mean, is it better than before but still not good enough?

52:08 Jessica Flanigan: As you can tell, I don’t think that it goes far enough. I think that right‐​to‐​try… It’s a good first step, I think. A lot of states have already had right‐​to‐​try legislation. I think a lot of the arguments against right‐​to‐​try are really misguided because, for example, people will say against right‐​to‐​try, “Well it doesn’t guarantee that people will have access to these drugs because the drug company can still say no.” Well, yeah, but I think it’s still progress if we’re eliminating legal barriers between patients and accessing medication that could potentially help them. It doesn’t do as much as I think some people think or hope it will. But I think it’s a first step, and I think expressively it’s good. I think it’s good to just affirm the fact that patients have a right to access therapeutics that people are willing to provide without the government interfering with them.

53:13 Trevor Burrus: So how does the world look in Jess’ world if we got rid of a bunch of this stuff and adjusted these things. How do patients try to find these drugs, how do they get information, how should the world look if you had your way?

53:28 Jessica Flanigan: It might not look that different for most people. You might think, “Oh my gosh, pharmaceutical freedom. If people had the right to use any kind of a drug, you would just be able to buy heroin at Walgreen’s, or you could access anything without it being prohibited.” Yeah, I do think that that would be a better world, but just because you would have access to those types of drugs… If you had access to any drug that you could possibly use, does that mean that you would necessarily walk down to your local CVS and buy a bunch of methamphetamine? Probably not. Probably most people wouldn’t use these drugs if they aren’t already having a standing interest in using recreational drugs in this way.

54:15 Jessica Flanigan: If you had the right to access drugs without a prescription, maybe people sometimes would. But I think people are pretty conscientious about their health in a lot of cases, and they might think, “You know what, I’m gonna ask my doctor about that.” And they might check in with the doctor even if they didn’t have a prescription requirement. They might see if a drug is FDA certified, even if they weren’t legally required to only use FDA‐​certified drugs. Now it is true that some people might make different choices, but if they’re making different choices, that might be an indicator that the current system is harming them by limiting their choices in these ways. So people who access drugs, that currently require a prescription… So that if we didn’t have prescription requirements, maybe some people would access drugs that currently require a prescription because they didn’t have to pay a doctor’s co‐​pay. And maybe it would have been better if they had talked to a doctor. But I think we could do better at kind of communicating information to patients.

55:09 Jessica Flanigan: And I think that right now, we are just already deciding that it’s worth it, that some people forgo care ’cause they can’t afford to see a doctor, to have the doctor recommend a drug, that that’s a better trade‐​off to make than letting people decide whether or not they should go pay to see a doctor, to have the doctor recommend a drug, versus just accessing a drug directly. I also think that if we did have more robust rights to self‐​medicate, people might become more informed consumers. So I think that there is little incentive right now for people to educate themselves about the content of the drugs they’re taking.

55:45 Jessica Flanigan: And there’s some limited evidence, which isn’t great evidence, but it’s kind of all we’ve got in testing the effects of prescription requirements, that suggests that people might even make more risky decisions because they’re just deferring to their doctors. So they’re like, “Oh, my doctor prescribed this. My doctor said it was okay.” And people aren’t really learning about their drug choices, considering the risks and benefits of their drug choices. They just are kind of offloading that deliberative process to the gatekeepers who are legally empowered to make those choices. But if people had rights of self‐​medication, they might invest more in educating themselves about the nature of the drugs that they’re using, the nature of their condition.

56:25 Jessica Flanigan: Right now, they have no incentive to learn more about the drug choices they’re making. And so we view how people might make these decisions, thinking about their current level of capacity. But I think that’s a mistake because, if people have the rights of self‐​medication, they might have greater capacities to make informed decisions about drugs. A lot of times people will think about paternalism and paternalistic laws, in terms of helping people. But, if we think about the history of paternalism, paternalism is often used to kind of justify treating people in ways that are really disrespectful. So there were paternalistic justifications of not letting women own property. Or paternalistic justifications of violations of civil rights.

57:11 Jessica Flanigan: And I think that there is a similar thing that happens here which is, patients as a group lack a kind of voice or power, which I think partly they’re taking it back now, with this right‐​to‐​try movement and medical marijuana advocacy. But historically, patients are kind of a vulnerable group. They’ve lacked a voice in this way, and they have… Paternalism has been harmful to them, but they have sort of lacked a voice in the conversations in a way. And I think that the 1980s was really the beginning of patients reframing rights of self‐​medication as a sort of civil rights and human rights issue with the AIDS ACT-UP movement.

57:53 Jessica Flanigan: And I see this book, and thinking about rights of self‐​medication more generally, as sort of within that kind of broader historical sweep of talking about anti‐​paternalism as also just sort of saying, like, talking about how it’s disrespectful for the government to express that people are incapable of making self‐​regarding decisions about their own lives, and that the government… Public officials are not entitled to do that. And so I kind of see it as this kind of, as continuous with that conversation. And that we should start thinking about rights of that self‐​medication as continuous with human rights, as continuous with rights to make decisions about your own body. And having a kind of more respectful relationship, between people and their government, in that way.

58:40 Trevor Burrus: Thanks for listening. Free Thoughts is produced by Tess Terrible. If you enjoy Free Thoughts, please rate and review us on iTunes. To learn more, visit us on the web at www​.lib​er​tar​i​an​ism​.org.