 Welcome to Hawaii Together on the Think Tech Hawaii Broadcast Network. I'm Kelea Akina, the president of the Grassroot Institute of Hawaii, where we believe in defending our fundamental freedoms. One of those freedoms is the right to speech, free speech. We believe in that deeply and we understand it. But did you know we also have a right to use and treat our bodies in the way we want to be treated? But that is something that comes up against federal regulation when it comes to the use of prescription drugs, both in terms of their cost and their availability. I've got an expert with me today who understands this issue and is doing some pioneer work in helping people to think it through and develop good policy. His name is Dr. Jeffrey A. Singer. He operates a clinic for general surgery in Phoenix, Arizona. He's very well known in terms of his work in his field. But he's also a public policy expert and a senior fellow at the Cato Institute and works with various think tanks and other policy organizations to come up with better policies in terms of medicine for the medical profession and for consumers, which happen to be patients. I'd like to welcome Jeff Singer to our program today. Jeff, welcome to Hawaii Together today. Aloha. Aloha. I wish I could be there physically. Yes, I wish you could be here. As you see beautiful Waikiki Beach and Honolulu behind me. Maybe we'll get you out here soon. You've done a lot of work in terms of the rights of individuals to use the kinds of prescriptions that they deem that are worthwhile for them as patients. But we seem to have a problem in this country in terms of their availability due to federal regulation. What kinds of problems do we have? Well, first of all, ever since believe it or not 1951, most people are unaware of this, ever since 1951, the Food and Drug Administration was given the authority to decide what drugs can be prescription only and what drugs are over the counter. Previously, prior to that time, the Food and Drug Administration was only concerned with making sure that drugs that were being brought to market were safe. And whether or not the drug would be available by prescription only was a decision that would be made by the drug maker. Sometimes they decide that it's complicated and they didn't want to take the liability risk to have the drug available over the counter. So they would say to the drugist that you can only give this to a customer if they have a prescription. But other times that wasn't the case. So people would get a prescription from their physician. They would consult with the pharmacist as well, who is very knowledgeable, sometimes more knowledgeable than physicians on drugs and drug interactions, and then they'd make their own decision as to what was best for them. That power was taken away by the federal government in 1951. So now the FDA decides what's over the counter and what's prescription only. As a rule, when drugs are prescription only, they cost a lot more than they become once they are switched to over the counter. Without history, when drugs have been reclassified to over the counter from prescription only by the FDA, you could see the prices drop dramatically. They become subject to a competition from like products and consumers do what consumers do, which is a comparison shop. They ask a lot of questions. And also when drugs are prescription only, that raises costs in other ways. For example, in most cases, you can't get the drug unless you take time off from work, get an appointment with a doctor, maybe spend a couple hours doing that, and then have to pay the doctor's fee to get the prescription. So there are costs to the patient in terms of possibly unnecessary visits to, what amounts to a government-approved gatekeeper, a licensed physician, to give you permission to get a drug. And that's an extra cost. Jeff, it sounds like there are at least two problems. One you've highlighted, which is the higher cost of getting prescription drugs because of federal regulation. But also, isn't there the problem that patients may not have the choices that they should have in terms of how they need to be treated because all of this must be regulated by a physician? That's true. They're not allowed to make their own decisions. Most people are unaware. This is kind of sad today, but the right to self-medicate has been considered a sacred right going back to basically to be any other founding. In fact, Thomas Jefferson, when he's once trying to describe to an audience why the right to free speech must be taken seriously as a sacred right. He actually said it's as sacred as the right to self-medicate, to illustrate to the audience how important it was. And it was only recently that people have kind of become accustomed to having to ask another adult for a permission slip in order to medicate yourself and make your own decisions about what you want to put into your own body. In fact, when the Food, Drug, and Cosmetic Act was passed in 1938 prior to that 1951 action I was telling you about, it actually said in there, nothing in this act is intended to infringe upon the right to self-medicate. The intention of this act is only intended to make self-medication safer. About the turn of the 20th century, people started to come to accept as another tenant of autonomy the right to inform consent. Now today, nobody would even imagine not accepting the right to inform consent. That's basically a pillar of medical ethics. Everyone agrees about this. Jeff, why don't you for a moment here define for us exactly what is meant by the right to inform consent? And how it relates to the right to self-medication. Okay, well, the best way to illustrate it is with the very famous case that led to the establishment of it in law. Back in the early 20th century, 19, I think it was 1908, a woman in New York state named Mary Shloendorf gave permission to her doctors to examine her under anesthesia but explicitly said, if you find anything, I do not want you to operate on me. I want you to wake me up. I want to discuss it with you. I do not give you permission to operate on me. The doctors examined her under anesthesia and they felt a tumor of the uterus and they proceeded to perform a hysterectomy. And she had complications from that surgery. She sued the doctors in the hospital for assault. She said, I didn't give you permission and this was assault. And the judge in the case, Benjamin Cardozo later became a Supreme Court justice, actually said that this is a fundamental right to inform consent that a person owns their own body and no one has the right to do anything to that person's body without that person's consent. But believe it or not, it wasn't until the latter part of the 20th century that that became kind of the accepted way. In fact, as recently as when I was in medical school, there were cancer specialists in the 1970s who would intentionally not tell their own patient that they had cancer because they thought it might make them too emotional and unable to cooperate in the treatment, to tell their loved ones and keep their own patient in the dark, which was not informed consent. Nowadays, everyone agrees that's medically unethical. Well, I think that we have a word for this. It's called paternalism, whether it's the physician practicing this paternalism or as the agent of the state, the state practicing paternalism. Let me play devil's advocate for a moment, Jeff, though. Sure. The argument goes that if you just let people make their own decisions in regard to their health, they don't have the education, the background, the knowledge, the experience with which to make good decisions. Therefore, the state should prevent them from making those decisions and vest that only in the hands of physicians. How do you respond to that? Well, just on a moral level, I just think that's immoral. Everyone owns their own body and has a right to decide what they want to do with their own body. So just on a moral level, but also looking at it from a different angle, other people who are suddenly becoming your keepers who are telling you what you can and cannot do, they're not infallible either. I mean, I'm a doctor and I could tell you with all honesty, we make mistakes. That's why we have malpractice cases, for example. And there's some doctors who are unethical. So the notion that picking another person to make decisions for you is in your best interest, I think that unless you're a child and you haven't developed yet to maturity where you can make your own decisions or you have cognitive impairment, then of course we can make exceptions and have guardians appointed. And the other thing is that there's actually empiric evidence that when people make their own decisions, they tend to be much more careful than when they get decisions made for them by a physician. For example, there was a well-known study done birth control pills as an example, okay? Birth control pills are prescription-only in the United States. In 102 countries, they're available over the counter. The American College of Obstetrics and Gynecology, as well as the American Academy of Family Practice, for over 20 years have been urging the Food and Drug Administration to make them available over the counter. Some states, including Hawaii, I guess we'll talk about that a little later, have come up with workarounds to make it a little easier for women to get it. But the fact is here you got specialists who have a vested interest actually, economically, in wanting to have people be required to come to them to pay them for a prescription and for an exam, and they're saying you don't need this. You should be able to get it over the counter, but it's still prescription-only in the United States. So at the University of Washington, Seattle, they did a study where they asked women to fill out a questionnaire, a self-screening questionnaire to decide whether or not they think they are a good candidate or a bad candidate to go on oral contraceptives. And what they found is the women were in agreement with the doctors 90% of the time. The 10% of the time the women weren't in agreement with the doctors, it's because the women were actually more conservative than the doctors were. The doctors said it was okay when women actually said it's not okay. And generally, as a rule, there have been a lot of evidence to suggest that when people are making their own decisions, I know when I am, when I go myself to, I don't know every single drug that exists and all of the risks and benefits. So when I purchase over the counter from a pharmacy, I read the labels. I avail myself of information on the internet. I ask the pharmacist who knows a lot about medications. I prescribe medications. I'm a doctor. It's not unusual for me to get a phone call from a pharmacist. So what you're basically saying is that fundamentally there is a right to make your own decision. And when people are allowed to make their own decisions, they tend statistically to make good decisions. And, and also they tend statistically when the doctor is making the decisions, they tend not to do as much due diligence because they assume, well, the doctor is the expert. If he's prescribing this, then I guess it's okay. And I could, I, I'll admit there been, it's not that uncommon for me even. I'll get a phone call from a pharmacist where I prescribed, let's say an antibiotic for one of my surgical patients with an infection. And the pharmacist will phone me at the office and say, you know, I noticed you prescribed this antibiotic. You know, the patient is on this blood pressure pill and this particular antibiotic has a dangerous interaction with that blood pressure pill. I really advise that you don't use this antibiotic. And I'm not aware of that because the pharmacist is actually their experts. They're more knowledgeable. So sometimes when that happens, they'll say, Oh, thank you so much for letting me know that. Then let's switch to something safer. And I'll ask, how about this one? Is this okay? Yeah, that one's safe. So this happens all the time. Well, so the point is, had that pharmacist not called me, my patient would have just taken my word for it. I mean, I'm not going to prescribe something dangerous. I'm a doctor. And that patient could have taken something dangerous. So in general, not only is it moral for people to have the right to make their own decisions about their own health and their own bodies, but it's also just from a practical standpoint, when they're responsible for the decisions about their own bodies, they're much more careful than they otherwise are when they have a tendency, understandably, to kind of put themselves in the hands of this so-called expert who is paternalistic. Well, that makes a lot of sense, Jeff. We're going to go to a break quickly, but basically to sum up, there's a moral imperative that people have to medicate themselves as they see fit. And in addition to that, they have the right to inform consent so that things aren't done to them that they're unaware of. When we come back, I want to ask you about the nuts and bolts in terms of how we can implement a fairer regime in terms of getting people the right to exercise their self-medication. And don't go away. You and I may not be able to hear each other during the break, Jeff, but the audience will have some very important announcements and we'll be back on Think Tech Hawaii's Hawaii Together in just one minute. Don't go away. Aloha. My name is Wendy Lowe, and I want you to join me as we take our health back. On my show, all we do is talk about things in everyday life, in Hawaii or abroad. I have guests on board that will just talk about different aspects of health in every way, whether it's medical health, nutritional health, diabetic health. You name it, we'll talk about it. Even financial health. We'll even have some of the Miss Hawaii's on board and some of the different topics that I feel will make your health and your lifestyle a lot better. So come join me. I welcome you to take your health back. Mahalo. Aloha, Stan, the energy man here. You can see me every Tuesday at 3 p.m. here on Think Tech Hawaii. We're not on Friday anymore, so don't be looking for me on Friday. I'm on Tuesday at 3 p.m. here on Think Tech, coming to you live and direct from the beautiful studios in downtown Honolulu's Pioneer Plaza. So please join me, and we'll talk everything about hydrogen and clean energy, not only for Hawaii, but for the whole wide world. Aloha. Welcome back to Hawaii Together. I'm Kayleigh Akina, President of Grassroot Institute, and you're on the Think Tech Hawaii Broadcast Network. My guest today is an expert in the field of medical practice and policy. He's Dr. Jeffrey A. Singer from Arizona and a senior fellow at the Cato Institute. We're going to dive right back into our fascinating conversation on the right to self-medicate. Jeff, on a very practical level, what kind of benefits would the consumer get if prescription drugs were available generally over the counter rather than having to go through all of the federally prescribed protocols needed to get them from a physician or a hospital? Well, bear in mind that in an ideal world where the government wasn't deciding this, there would still be, especially with today's complex pharmaceuticals, there would be many cases where the pharmaceutical company would sell it only under a prescription, and of course that's a proprietary voluntary decision made by the pharmaceutical company based upon their own liability concerns, so that would continue. That would be driven largely by the market itself. By the market and by liability concerns of the manufacturer, and that's the way it should be. In other words, we wouldn't necessarily have just a free-for-all. There would be some regulating mechanisms, even if the government were less involved. Exactly, in fact, even before the government got involved with this pharmaceutical companies were already selling certain drugs under those stipulations, so that would, especially with today's complicated chemotherapy agents, etc., we're not going to see a lot of that change, except it'll be much easier for other types of drugs like antacids, cold remedies, lots of things, and I'll get into a few. They could be moved over to the counter. So what kind of over-the-counter movement would you like to see, and what benefit would that bring the patient? Just a few things come to mind, birth control pills, like I said. Right now, you can only get them by prescription. Now again, a lot of this, when the government is in charge, a lot of the decisions are not based on safety, they're actually based on politics. So for example, the morning after pill, Plan B, that was approved by the FDA for prescription only in 1999, and in 2003, a recommendation of the advisory board overwhelmingly said it should be made over-the-counter, but the Bush administration resisted until 2006, and then it was recommended that it be made over-the-counter until under-18 in 2011, and the Obama administration resisted until finally in 2013, the court ordered that Plan B be made available over-the-counter. So that was just all politics. Now Naloxone, the opioid overdose antidote, we hear the surgeon general going around the country urging everybody to get a hold of it, but that's prescription only. Even though in Australia and in Italy and some other European countries, you can get it over-the-counter. It's being given out to first responders, you can't overdose on it, you can't hurt yourself with it. That should be made over-the-counter. The FDA has not done so, even though they've actually invited the drug makers to ask them to make it over-the-counter, and for your listeners to know, you don't have to be asked. You could just order it over-the-counter if you want to. But obviously there's some political reasons involved here, so they've not made that over-the-counter. Recently, a great development has come about in what's called pre-exposure prophylaxis and post-exposure prophylaxis for HIV, or PrEP and PEP. They're two brands out, Truvada and Discovy, and if they're taken in association with exposure, sexual exposure to HIV, it could reduce the risk of HIV by 99%. That's prescription-only drug. The side effects from it are relatively innocuous, and they should be made available over-the-counter. Now, these are all federal decisions, but states do have in their power ways to at least mitigate some of these detrimental effects, these obstacles that the federal government puts in the way of patients. So, and Hawaii has been good on a number of reasons. For example, Hawaii is one of about 12 states now, and the District of Columbia, that allows pharmacists to prescribe birth control pills. Because what states have power is they have the power to decide the scope of practice of healthcare practitioners. And under the FDA regulations, a prescription drug can only be prescribed by a healthcare practitioner licensed by the state. But the scope of those healthcare practitioners licensed by the state is determined by the state. So, Hawaii and many other states have said, well, a pharmacist can prescribe. So at least that's still an obstacle. You still have to go to the drugstore and you have to ask the pharmacist for a prescription, but that's at least better than spending $100 or more and taking three hours off of work to go to a doctor's office. So that's an improvement. Every one of the 50 states has allowed naloxone to be prescribed, be given out by the pharmacist. They've either allowed the pharmacist to prescribe it or many states have done what's called a standing order. If the state's health director happens to be a physician, then that health director has acted as the physician and basically says, I'm giving you an order to all pharmacists in the state. If a person comes up to you and wants naloxone, I'll be the ordering physician. So that's the way around it. Well, you know, you're talking about the authorities that the states still retain, one of them being the definition of what goes into the scope of practice for a practitioner. You mentioned pharmacists, for example. What other kinds of things would you like to see pharmacists able to do? Well, for example, in California, this is the first state to do this state, allow pharmacists now to prescribe pre-exposure prophylaxis and post-exposure prophylaxis for HIV. According to the Centers for Disease Control and Prevention, the overall majority of new cases of HIV are from sexual transmission. And the remainder are from sharing dirty needles, which PrEP and PEP also is very effective for. So California is now allowing you to go into a pharmacy and a pharmacist can prescribe it to you instead of you having to make a doctor's appointment. They should do that in Hawaii and all the other states. And there's a whole host of drugs that either the state can move from prescription to over-the-counter, rather from a doctor prescribed to pharmacist prescribed, or they can even have the state health director give a standing order like it's being done for naloxone, where the state health director can say, I'll be the prescribing doctor. If somebody wants PrEP or PEP or birth control pills, you put that under me. Other things that scope of practice, things that states can do, all 50 states now allow pharmacists again to give vaccinations. But some states allow them to vaccinate for more things than others. Some states have restrictions regarding whether they're for children or not. A couple of states allow pharmacy techs to give vaccinations in addition to the pharmacists. So those are things that states can do, allowing pharmacists to prescribe and give vaccinations. Pharmacists should be able to, for example, do throat swab tests to see if you have a strep throat, which is just a simple test with a swab. And then if it's positive, they can prescribe the common antibiotic for you for the strep throat. By the way, none of this means that a pharmacist is prevented from saying, I don't feel comfortable treating your problem. Maybe you should see a doctor. They're not forced to do this. But so many times, you know, you have a strep throat. If you could buy the pregnancy test over the counter, why can't you get that swab for your strep throat over the counter? I can also imagine that there are other professionals, a pair of medical professionals, optometrists, nurse practitioners, physicians, assistants, and so forth. Even clinical psychologists, for example. Yes. Clinical psychologists. Talk a bit about that. Okay. Now this is a little different, but not all, but many clinical psychologists who have doctorate level degrees, either a PhD in psychology or a doctor of psychology, PsyD, many of them have had extensive training in psychopharmacology. And sometimes when they'll see a patient who's, you know, in dire straits and they're agitated, they need to get them on some sort of medication so that they can do the therapy, some, you know, antidepressant or whatever. And many of them are trained to be able to do that, but state licensing laws don't allow them to. So then they have to send you to a psychiatrist in order for the psychiatrist to prescribe the medication. So that's another time out of your day to go to see the psychiatrist. And in another expense, most psychiatrists don't accept insurance. And then understanding the psychiatrist is going to want to see you back regularly because if the psychiatrist is assuming the liability risk of prescribing this, the psychiatrist needs to follow you. So you've got this extra expense where this could all have been done by the psychologist. Guam, many years ago, started allowing clinical psychologists who had the adequate training to prescribe psychopharmacologic agents. And now there are five states, Idaho in Illinois and New Mexico and Louisiana. So these are other things that we can consider on a state level. All of these things, this is not as good as allowing us patients to control again over our own self-medicating decisions. Now we're not talking... There are enough obstacles that, you know, it makes it easier for us to get access and less costly. And we're not talking just about prescriptions. What about lab tests, for example? Direct-to-consumer lab tests? What do you see in terms of expanding that? Yeah, I don't know about Hawaii, but I'm pretty sure every state now allows direct-to-consumer lab tests. You can walk into a lab and say what test you want. With the exception of Massachusetts, New York, New Jersey, Maryland, and Rhode Island, they have restrictions, unfortunately. And there are a lot of advantages to that. Number one, how many people could relate a story of they got a blood test at the doctor's office and the doctor's office never called them. So they assumed the test was normal, but maybe it wasn't. Well, when you get your own lab test, you get the test results right away. That's right. And again, so that's one thing. Now you may get a test and you don't know whether or not it's something you should be worried about. Well, then you can always make an appointment with an expert and get an opinion about it. But instead of having to go to a doctor to get a prescription, to go to a lab to get the blood test drawn, so this is another thing that we could do on a state level. These are within the purview of state legislatures. And when the consumer is a market to be demanding the lab tests, I think that there's going to be a quicker turnaround time because there will be competition between different labs. Let's just step back a little bit and look at the overall market. With CVS just expanding everywhere and bringing pharmacy services to almost every neighborhood, we may see pharmaceutical services available in 7-Elevens and so forth. And as there's access like this, what do you think happens ultimately to the market and to the quality of medical care across the country? I think it actually compels doctors and other healthcare practitioners to give better service because when people can take matters into their own hands more readily and not captive of this paternalistic system, then the healthcare professionals basically have to prove to the consumer why it's important to come to them. So it actually makes for a much more accountable and responsive healthcare practitioners. I'd like to add a couple of more things that could be done on the state level. For example, let's say you're running out, your prescription is running out and you can't get into your doctor for a refill and your prescription was only for this one month's period. This should be able to give the scope of practice where they can extend the prescription to 30 to 60 days to allow you the time to get in to see your doctor and discuss it again. Those are things that, again, states can do. That sounds good. Well, Jeff, you've come up with some wild ideas too, turning pharmacists into activists as well. And if there's any interest in following up with your work, reading a book or an article, as we close right now, can you tell our viewers how they can get a hold of you and how they should log into? You can go to the Kato Institute's website, cato.org. If you go under experts, click on the experts, you'll see an alphabetical order of the different experts. I'm there. You click on my name and we'll get you all the things that I've written. Many other of my colleagues write on this as well. It's not just me. And I also have a book I'd like to recommend to your viewers. It's not from the Kato Institute. It's called Pharmaceutical Freedom by Jessica Flanigan. She's a professor of medical ethics at the University of Richmond. And that book goes into this a lot as well, particularly the moral and philosophical foundations of the right to self-medicate. Sounds great. It's an excellent book. Well, Dr. Jeffrey A. Singer, thank you so much for your time today. You hit it on the nail. And I thank you so much. Thank you. Aloha. And aloha to all my viewers. We'll be back again next week on Think Tech Hawaii's Hawaii Together. I'm Kayleigh Akina with the Grassroot Institute. Aloha.