2020-11-21 · Guest: Jeffrey Singer (Senior Fellow at the Cato Institute) · 52:25

Filed under: Health and medicine
Topics: FDA

Ending Government Power to Require Drug Prescriptions

Bob Zadek and Dr. Jeff Singer discuss the history and consequences of the US prescription drug system, tracing its origins from a voluntary recommendation to a government-mandated restriction. They argue for a “Drug Reformation” to end the FDA’s power to require prescriptions, highlighting how current policies undermine patient autonomy, increase drug prices, and allow political interference in medical decisions.

Topics: Prescription Drugs, FDA, Drug Reformation, Cato Institute, Durham-Humphrey Amendment, Plan B, Drug Prices, Healthcare Policy, Patient Autonomy

Speakers:

Bob Zadek: Host
Dr. Jeff Singer: Senior Fellow at the Cato Institute

Introduction and the COVID-19 Test Prescription [00:00]

Bob Zadek: Hello everyone, welcome to The Bob Zadek Show, the longest-running live libertarian talk radio show in all of radio. Thank you so much for listening this Sunday morning. Well, with us being inundated day and night by the health crisis—the claimed health crisis caused by COVID-19, of course—with us being inundated daily with new cases and with deaths and with hospitalizations, with us being inundated by claims, true or not, about the politicalization of the preparation, manufacture, and sale of a vaccine, with us being inundated about the politicalization of the lockdown.

In other words, all of our news these days is crowded out by medical/economic information. The economic information is a direct result of the medical situation we are living in. All of a sudden, us Americans are paying a lot more attention to the whole process of manufacture, distribution, sale, pricing of prescription and non-prescription drugs. What a perfect time for this morning’s guest, Dr. Jeffrey Singer, to have published an important paper over at Cato. Jeffrey and his co-author, Michael Cannon, also at Cato, introduce us all to the not-so-complex but fascinating history of prescription drug availability, sale, and use in America. And what a fascinating history it is.

It occurred to me that all of us, most of us, probably all of us use prescription drugs. We buy them, we acquire them from our pharmacies and the like. We acquire over-the-counter drugs from our pharmacies and from our supermarkets. But probably none of us have given much thought to the whole concept of prescription drugs and the use of prescriptions. When you think about it, as you will during this hour, prescription drugs are just another aspect of the permission-full society we live in, where so much of the operation of our daily lives requires the permission of a government official. It’s been around for so long we sort of take it for granted. But should we be required to seek permission from anybody to put something into our body? That is this morning’s question. I dare say many of you will change your opinion about an hour from now. To help us understand this fascinating, complex subject of prescription drug use in America, I’m happy to welcome back to the show Dr. Jeffrey Singer. Jeffrey writes over at Cato. He is a senior fellow at Cato and he works in the Department of Health Policy Studies. And as I said, he has just published with Michael Cannon, Drug Reformation: End Government’s Power to Require Prescriptions. Jeff, thank you very much for joining us this morning.

Dr. Jeff Singer: Oh, it’s a pleasure to be here. And you know, as you were mentioning the COVID-19 pandemic, it just came to my mind a perfect sort of lead-in, a setup for what we want to talk about today. As many of your listeners probably know, just a few days ago, the FDA gave emergency use authorization for the first-ever at-home self-administered test for COVID. But they said that you can’t get it without a prescription, and a doctor is not to prescribe it for you unless you have symptoms. So here’s this thing where you could finally take it at home without going to a doctor’s office and risk contaminating other people or getting contaminated. But in order to get it at home, you’ve got to get a permission slip from a doctor, and he’s not allowed to grant you permission unless you’re symptomatic. And then on top of that, we just hear even recently that the reason why this pandemic is so difficult to control is because about 40 to 50% of people have no symptoms and they’re spreading it around unknowingly. And here’s an opportunity for people who are conscious of that fact to test themselves to see if, even though they have no symptoms, do they have COVID? But they’re not allowed to because they have to get a permission slip and they have to have symptoms to get the permission slip. So this is a perfect lead-in to what we want to talk about today.

Bob Zadek: Now Jeff, without getting sidetracked onto COVID, but you piqued my curiosity. What is the rationale, if there is one, behind requiring a prescription to do something as benign as testing to see if you have COVID-19? Since the FDA is designed, one would think, to protect us from doing bad things to our body, how could testing for COVID-19 be a bad thing and therefore what’s the reason for the prescription?

Dr. Jeff Singer: I have no idea. There’s no prescription required for the at-home pregnancy test or an at-home HIV test. But for an at-home COVID test, it’s designed for at-home use. And in fact, the FDA’s memo actually stated that when you get the prescription from a doctor, you could still do it yourself. The doctor is not necessary to provide the test on you. So then why get permission? That’s just, you know, one example of how the government is standing in the way of us being able to take care of ourselves, make our own decisions about testing ourselves and medicating ourselves. So that’s just the most recent and most timely example of what we go into in great detail in our white paper, Drug Reformation.

The History of the Prescription Requirement [03:55]

Bob Zadek: Now Jeff, most of the people, probably everybody listening to the show, has been born into a system of prescriptions as a requirement for us to buy and to administer to ourselves certain drugs. But in the history of our country, prescriptions are relatively new. So tell us briefly, when did the reliance upon prescriptions as governing who can buy what medication, when did all of this start and for what reason?

Dr. Jeff Singer: Yeah, actually this started in 1951. Prior to that time, it was widely recognized that every human being has the right to self-medicate. And the right to self-medicate is sort of a corollary of the right to informed consent. So for example, you can’t perform a procedure on me or make me take a medicine without my informed consent, even if I’m making a terrible decision not listening to you. It’s understood by everyone that you have to respect my decision either way. A corollary of that is if I want to medicate myself or perform a test on myself, I shouldn’t need your consent for me to do that. That’s just as well my right.

And in fact, back in colonial times, Thomas Jefferson was speaking to a group about freedom of speech. And he, to explain that point, said freedom of speech is so sacred, it’s as sacred as the right to self-medicate. So this was kind of considered in those days so self-evident that he was using that as an example of how important the right to free speech is. And now we’ve come completely 180 degrees. So nowadays I have to explain to people that the right to self-medicate is as sacred as the right to free speech.

So what happened was up until the 1950s, if you—even though evidence shows that the overwhelming majority of people who took medications sought the advice of an expert like a doctor. But pharmacists are also experts. And people would go into a pharmacy and they oftentimes would consult the pharmacist and ask what the pharmacist recommends, but they would ultimately at the end of the day make their own decision. They may have carried with them a prescription from their doctor, which was the doctor’s recommendation. And sometimes the pharmacist would look at the prescription and say, “Well, could I suggest something else?” and make the case for it, and the individual would at the end of the day make the decision. So this prescription wasn’t a permission slip; it was a recommendation.

The Sulfanilamide Disaster and the 1938 Act [06:41]

Dr. Jeff Singer: And this was going on fine. And then in 1938, there was a huge catastrophe occurred. It was called the sulfanilamide scandal. So sulfanilamide, a sulfa drug, was the first ever antibiotic ever invented. And it was a miracle because people were dying of infectious diseases so often. And in 1938, the company Massengill developed an oral elixir form so that people who couldn’t take pills or children could then take it because it was an elixir. And unfortunately, the chemist who developed it used as the solvent for the sulfanilamide diethylene glycol, which is chemically related to ethylene glycol or antifreeze, and it was poisonous. So there were 105 deaths due to taking sulfanilamide, and 34 of them were in children.

And of course, this was terrible. And this led to the Congress passing the Food, Drug, and Cosmetic Act of 1938. Up until then, the only act in effect was the Pure Food and Drug Act of 1906, which basically created what became the Food and Drug Administration. And they were just basically—it was almost like a truth-in-advertising act. Any product that was sold was tested to make sure it’s what it said it was and didn’t have any adulterants or intoxicants that could hurt people, that it was whatever the manufacturer said was in there was in there. That’s all that the FDA was dealing with at that time.

But after 1938, the Food, Drug, and Cosmetic Act said that from this point forward, any new product that any manufacturer wants to bring to market has to go through a testing process until we’re persuaded that it’s safe to be sold to the public. And anything currently in use is exempted from this. So by that time, aspirin was exempt, insulin was exempt because that was around since around the time of World War I. And that’s why to this day there are a couple of types of insulin you can get over the counter in the United States. And but that from that point forward you had to persuade the FDA that it was safe or they won’t let you market it.

And if you marketed it, if the manufacturer decided that they wanted to market it over the counter, they had to make the labeling clear enough that a person with a very rudimentary education could understand it. The FDA had to approve the labeling. If they had chosen to make it by prescription only, which was a decision of the manufacturer, then they wouldn’t have to satisfy the labeling requirements because that would become the responsibility of the prescriber. And even before 1938, there were manufacturers deciding as a proprietary decision that we want to make this available by prescription only because we think this somebody might be able to use it the wrong way and hurt themselves and we don’t want the liability. And so they would supply the pharmacies under the stipulation that the pharmacies couldn’t sell that product to someone without a prescription. That was already a private sector decision.

The Durham-Humphrey Amendment of 1951 [09:30]

Bob Zadek: Jeff, let me just interrupt to bring the audience up to date with where you are in your story. In 1951, the change was profound. Up until 1951, the decision upon what drugs you could take was between you and your physician as to whether your physician would write a prescription. The manufacturers could require prescriptions if they want, but basically the decision was to a considerable extent yours and perhaps your physician’s. After 1951, a profound change happened and that basic decision about medication was taken from the physician and the patient to the government. Is that a fair summary of where we are so far?

Dr. Jeff Singer: Yeah, actually to be more precise, the decision was always the patient’s. The patients would consult their physicians most commonly, but even if the physician wrote a prescription, the patient sometimes could get another opinion from, let’s say, the pharmacist. And then at the end of the day, the patient would decide what to take, not the physician. But overwhelming majority of time, and this is reasonable, people would want the advice of a person who’s an expert and they would consult the physician.

So now that decision now, a substantial portion of decision-making as to what drugs you could take on your own decision was removed and was placed in the hands of the FDA and the government in general. So that’s post-1951. And that changed everything because that suddenly, as I’m sure a lot of your listeners are very acutely aware of, that changed the decision from being one not only of—it stopped respecting of course the autonomy of the individual patient, but it also made all decisions going forward subject to politics. Because now you have all different special interest groups and you have political concerns that influence whether the Food and Drug Administration is going to make something that is currently prescription-only over the counter and vice versa.

Safety, Autonomy, and the Knowledge Problem [12:05]

Dr. Jeff Singer: It also, we point out in our paper, that contrary to what people think, it actually didn’t increase safety. Sam Peltzman, who did a lot as an economist at University of Chicago, did a lot of work on this, actually showed empirically that since that requirement went into effect, the percentage of drug poisonings, you know, poor drug reactions, that kind of thing, actually increased relative then to the time before the prescription requirement was put in place by the FDA. And there are a lot of different reasons for it.

Bear in mind that when—and as an example, when the sulfanilamide disaster occurred, out of those 105 deaths, 95% of people who died from the sulfanilamide were taking it at the doctor’s recommendation. And if you look through the records, and we provide a lot of this in our paper, there were people who were calling the doctor and saying, “You know, my little girl’s getting sicker and sicker,” and the doctor would say, “Okay, then give more sulfanilamide elixir, double up on it.” So they were following the advice of their doctor. These were not people who were doing something reckless to themselves.

And there’s a lot of empirical evidence which we go into in our paper that people tend to be much more willing to trust the expert when they get a prescription drug than when they go over the counter. When you go over the counter, you do a lot more due diligence. You start asking a lot of questions, you comparison shop, you go up and ask the pharmacist some things, you may go online and do some research. Whereas there’s a tendency when a doctor prescribes it just to kind of assume, “Well, he’s the expert, I’ll just do what he says.”

I can tell you as a practicing physician, I see this often when I take a history on my patients and I’m trying to get their medication history. And they’ll say, “So what medications you take?” and they’ll say, “Well, I take a blue pill and a black and white striped pill and a red pill.” And what are they for? “I don’t know, I think one of them is for blood pressure and one of them is for cholesterol.” Those are the kind of things you’ll often get from patients and they don’t know what it is, they just know what to do because they’re following doctor’s orders.

On the other hand, if they’re going to medicate themselves, they know everything about it. And in fact, birth control pills, here’s another good example. In over 100 countries in this world, you can get them over the counter. In the United States, the American College of Obstetrics and Gynecology has for at least the last 15 years officially encouraged the FDA to make birth control pills available over the counter. And so has the American Academy of Family Practice. Now that means something because if the American Academy of OB-GYN has—they’re actually taking an economic hit. They’re saying you don’t need to come to me and pay me $150 so I can give you a prescription for birth control pill, you should be able to go get it yourself. And so they’re giving up money. So that means something for them to say that.

But despite that, it’s still prescription-only in this country. And at University of Washington in Seattle in 2006, there was a really interesting study done where they asked women to basically self-screen. They gave them a questionnaire and they asked them to determine based upon the questionnaire whether they think they are a good candidate for oral contraception because, you know, there are certain contraindications like if you’re a smoker it’s more dangerous, you can get a blood clot, and there are other things. So what they found was that the women who self-screened were in agreement with professional OB-GYN doctors 90% of the time. The 10% of the time that they weren’t in agreement is because the doctors were actually more liberal about it. The doctors thought they could take it and the women thought they shouldn’t take it. And of course that could mean one of two things. It could mean either that the doctors were reckless or that the women were overly cautious. We don’t know actually for sure. But the point is that that’s just another illustration of the fact that people tend to be actually much more involved and engaged when they’re making the decisions and there’s a tendency for them to surrender judgment and even in some cases even knowing what the medications are when it’s prescribed by someone.

And I’ll be the first to admit, doctors make mistakes. I can’t tell you—I’ll tell you honestly, for example, and I would argue that there’s not a single doctor who will deny this. I’ve as a surgeon, I’ve written a prescription here and there for a patient, let’s say an antibiotic for an infection, and then I get a phone call from the pharmacist saying he notices that I wrote a prescription for this infection and this patient is taking a certain drug, let’s say an anti-anxiety medication. And I say, “Yeah, I’m aware of that.” And the pharmacist will say, “Well, I don’t know if you’re aware, but that particular antibiotic has a terrible interaction with that anti-anxiety agent, so I really don’t recommend that you prescribe that.” And I’ll say, “You know, I wasn’t aware of that at all. Oh, thank you for letting me know.” Because obviously pharmacists are trained professionals who know more about this stuff usually than we doctors do. And then the pharmacists would say, “So what kind of infection are you treating because I could recommend some antibiotics that won’t have that interaction?” And then of course after discussion with the pharmacist, I’ll change the prescription. So there’s a perfect example. This happens all the time. Just because it’s prescribed by a doctor doesn’t necessarily mean it’s foolproof. There are, you know, we doctors don’t know every single thing, which is why there are different, you know, there’s a division of labor, there are different specialists, and pharmacists are very specialized in these kind of things. But so just because it’s a prescription-only doesn’t guarantee safety, and there’s empirical evidence that it probably makes you less safe.

The Politicalization of Plan B [15:05]

Bob Zadek: Jeff, your paper is entitled Drug Reformation. So you have described the existing system, full of politics, full of non-medical considerations. So in your paper, what is the reformation you call for and what would be the economic and the medical benefits and detriments, if there are any, to drug reformation? What is the headline of what you’re calling for in your paper and then share with us the economic and medical benefits?

Dr. Jeff Singer: Okay, well in our paper also we go into other areas that need to be reformed as well. But if we stay focused on the prescription requirement, what we argue is that ending the prescription requirement, number one, most importantly, respects patient autonomy and the right to self-medicate. Number two, likely increases patient safety. Number three, will likely lead to reduced drug prices. There’s a large amount of empirical evidence that when drugs move from prescription-only to over-the-counter, the prices drop, sometimes dramatically. And so we argue and we can get into that in a minute if you want, but we argue that we need to end the prescription requirement.

And then when people say, “Well, what would happen if the FDA gets out of that business?” Well, actually you’re not going to see a lot of changes because since 1951, there are a lot more complex drugs and the—there’s a really good likelihood that in many of these drugs, the pharmaceutical manufacturers are going to still require that the pharmacist dispense them only with a prescription because they’re going to have not only reputation concerns but they have liability concerns. But on the margin, a lot of the routine everyday drugs that can be moved to over-the-counter will get moved to over-the-counter, especially due to market forces and competition, and that will save people a lot of money. And so you won’t—and in addition to that, you’re going to probably have more patient engagement in their self-medication.

Also, there’s a lot of room for innovation. So for example, it doesn’t have to be binary: prescription or over-the-counter. In many of the other countries, there’s a third category, which is pharmacist-only or behind-the-counter. So for example, there are some countries like in England, you can get a statin drug behind the counter. So that means that you can’t just take it off the shelf with a box of razor blades and Band-Aids and go to the checkout counter; you’ve got to ask the pharmacist for it. And the pharmacist has an opportunity to ask you some questions before he decides to sell it to you to decide whether or not he thinks you know what you’re doing, and a pharmacist has a right to say, “I don’t want to sell it to you.” So that’s another option, for example, that pharmaceutical manufacturers will have at their disposal if we get rid of the Durham-Humphrey Amendment because they could say, “Well, this isn’t quite tricky enough where we want it to be prescription-only, but we’d like some person to be a buffer who knows about this stuff, so we’re going to say it can only be dispensed behind the counter by the pharmacist.” That’s another option.

When these things are over-the-counter, there’s so many more innovations that can come available. For example, if birth control pills were over-the-counter or naloxone was over-the-counter, you don’t just have to go to a pharmacy for over-the-counter drugs; you could get them at convenience stores, at the checkout counter in supermarkets, maybe in vending machines. They already are making Plan B available in vending machines in many places in college campuses. And by the way, there are companies now that have kiosks where you can do all your pharmacy out of a vending machine. That’s already in existence. So there’s so much room for innovation, but right now the FDA is standing in the way.

International Comparisons and the Case for OTC Insulin [18:30]

Bob Zadek: You mentioned economics. Tell us a bit about the drug manufacturers. That’s the starting point because they can designate—they have some say in whether a new drug is prescription-only or over-the-counter, but they don’t have ultimate control. The government has the ultimate control. So what are the economics? And you mentioned lower costs, but tell us a bit more about how that works through the system to produce lower prices to consumers.

Dr. Jeff Singer: Okay, there are three ways in which a drug can be converted today under today’s law from prescription-only to over-the-counter. One is if the manufacturer petitions that the FDA reconsider it. Two is if any interested person petitions. And three, the commissioner could just decide to make it over-the-counter. And oh, then the fourth way of course is Congress could pass a law saying it’s over-the-counter.

So generally speaking for the last 20-30 years, the FDA has—and this is probably due to a certain amount of regulatory capture—they have deferred to the manufacturer regardless of what individual groups have petitioned for. And what we’ve seen is that because health insurance generally doesn’t cover prescription drugs but only over-the-counter drugs—no, you have it backwards. I think you have it backwards. Health insurance covers prescription but not over-the-counter. Oh, okay, that’s what I said, but thank you for correcting me. So yeah, so that gives the manufacturers a great opportunity to sort of game the system. And I could tell you because as a doctor we do this too and so do hospitals. So you got this deep-pocketed third-party payer, the insurance company or Medicare or Medicaid or whatever, and the drug company charges a very high price, much higher than any individual would be willing to pay. And then of course it gets negotiated down to a lower price and they’re still doing quite well.

So there’s been a tendency of late for the drug manufacturers not to want to make it over-the-counter. So an excellent example of this is antihistamines. And this is also an example how prescription requirement doesn’t necessarily mean it’s safer. So the over-the-counter antihistamines were very sedating, like Benadryl, for example. They’re so sedating that the FAA wouldn’t allow a pilot to fly a commercial airplane under the influence of Benadryl. In 1993, Schering-Plough came out with the first non-sedating antihistamine, Claritin. Shortly thereafter, Zyrtec and Allegra came out, same thing, non-sedating antihistamines. These were prescription-only. So you had this situation where the safe non-sedating antihistamines you needed a prescription for, but the more dangerous over-the-counter sedating antihistamines you didn’t need a prescription for.

Meanwhile, Schering-Plough was lobbying the regulators in Europe to make Claritin over-the-counter. And it was, so it was over-the-counter in Europe but was prescription-only in the United States. In the late 90s, some health insurance plans petitioned because any interested person, they petitioned the FDA to make it over-the-counter because they were spending a fortune on paying out for prescription non-sedating antihistamines and they wanted this over-the-counter. Schering-Plough actually protested and lobbied against and lobbied successfully against making it over-the-counter, arguing it’s not safe. So at the same time they’re arguing to European regulators that this is safe and should be over-the-counter, they’re arguing to the FDA that it’s not safe and should be prescription-only. Why? Because they were making a ton of money on this, as were the makers of Zyrtec and Allegra. Finally in 2002, Schering-Plough came out with a new prescription non-sedating antihistamine and they started thinking with this pressure to make Claritin over-the-counter, now’s a good time to say to the FDA, “Yeah, we’d like you to make it over-the-counter,” because its name ID was so good that it’ll compete very, very effectively against the sedating antihistamines and we can make a ton of money on both the prescription line with our new product about to come out and on the OTC line with Claritin. So in 2002, Claritin became over-the-counter. In 2007, Zyrtec became over-the-counter and in 2011, Allegra became over-the-counter. But there’s a perfect example of it has nothing to do with safety. In fact, the dangerous drugs were over-the-counter and the safe drugs were prescription-only, but there were financial incentives to the pharmaceutical companies to keeping it over-the-counter.

The same thing’s happens with naloxone. The FDA for the last few years has practically been begging the makers of naloxone, the opioid overdose antidote, particularly Narcan, which is a nasal spray, they’ve been begging them to make it over-the-counter. They said, “This has been around since the 70s, it’s safe to use by non-professionals, if you don’t need it, nothing will happen if you take it, we recommend, we ask the manufacturers to ask us to make it over-the-counter.” And they’re not asking. And then they reached the point where about a year ago, Commissioner Scott Gottlieb at the time said, “We don’t usually do this, but we’re already taking the trouble of filling out the application for you and we’ve pre-approved the labeling that an over-the-counter version of your naloxone would require, and that’s usually your job, not our job. All you need to do basically is sign on the dotted line and we’ll go ahead and get the process moving,” and they won’t do it.

And then in October of 2019, I was a participant with another colleague, David Hyman, who’s an adjunct at the Cato Institute, at a Capitol Hill briefing in Washington where we were explaining to Capitol Hill staffers why Congress should just pass a law making naloxone over-the-counter. And we talk about this in our paper, the sales rep, the lobbyists, the sales representatives for the makers of naloxone were trying to contact us before the meeting and they cornered me after the meeting trying to make the argument, “Oh no, you don’t understand, it’s actually cheaper for the people if it’s prescription-only.” And I said, “I’m really curious to know how you could say that.” “Well, it’s $145 for two Narcan nasal spray packets, but you only have a $10 co-pay when you pay for it with your insurance, whereas otherwise it would be $145.” And of course my response was, “The people using, you know, IV heroin on the streets don’t usually have their insurance cards with them, okay?” And so that’s really not a big sales feature to them. But of course this is where they were coming from.

So by taking the government out of this and taking politics out of this, then we allow market competition to enter the fray. I mean, there’s a whole lot of other reforms. This isn’t the panacea. And in our paper, we actually spend a lot of time talking about other aspects of the regulatory system that need a reform, seriously need reform. But this is an important one and it’s an important place to start and it’ll go a long way towards improving affordability and safety.

Economic Consequences and Third-Party Payers [21:00]

Dr. Jeff Singer: In also in our paper, Michael Cannon discovered this by getting data from the Bureau of Labor Statistics. Here’s an example again how prescription versus over-the-counter and third-party payers plays a role. So even though birth control pills are prescription-only, up until the Affordable Care Act was passed, most health insurance policies would not cover birth control pills. So women would have to pay for it out of pocket. And if you look at the data up until about 2011 when the ACA officially went into effect—or rather was passed—the prices of birth control pills were actually trending down and following the same trend line of over-the-counter medications. And prescription pill prices were also prescription drug prices were also slowly trending down but not as rapidly as birth control pills and over-the-counter drugs. Then when the ACA went into effect in 2014 and insurance companies were required to pay for birth control pills and there was supposed to be no out-of-pocket expense to the purchase of birth control pills, not only did prescription drug prices start going up, but birth control pills prices started going up and they skyrocketed. Actually they went up at a rate three times the rate of prescription medicines going up, while over-the-counter medicines only went up slightly since 2014 in price. So what happened was as the cost and the feedback loop of people purchasing birth control pills disappeared, cost was no longer an issue to the consumer and the insurance companies were picking up the tab. Number one, the purchasers of it didn’t really care how much it cost, and number two, the manufacturers started overcharging because they could to a third party. And of course not everybody has health insurance and there are a lot of women, particularly low-income women, who now are priced out of the market for purchasing out of their own pocket birth control pills because of the way the price has gone up.

Bob Zadek: And what’s interesting is of course, even though one can say listening to your narrative that, well, the insurance companies picked it up, but duh, the insurance companies are determined to make a profit. Therefore, the premiums go up proportionately, which means of course consumers ultimately pay, but they pay in the increased cost a bit of their medical insurance, which means society bears the entire cost of subsidizing the people who actually use the medication, the prescription, the now birth control. So to say it’s like the cost of the drug are now free, of course they’re not free, Jeff, as you know, but I want to be sure the listeners understood that. That government has long since discovered that if they can pass a cost along to business to bury in the price of the product, in this case premiums, consumers don’t know that government has increased the cost because it is buried like sales tax. So nobody is particularly fooled.

The Efficacy Requirement and Drug Innovation [23:30]

Bob Zadek: Now Jeff, we only have a few minutes and I’m hopeful in a couple of minutes you can explain another point in your paper about the FDA’s role in determining the effectiveness of the drug. It’s a big topic, Jeff, we only have a minute or so, but should they be involved at all in determining whether a drug works? And tell us in about a minute, Jeff, how silly it is because once a drug is approved for one use, it’s approved for any use anybody wants.

Dr. Jeff Singer: Yeah, I’ll have to be real quick, but that basically is result of the Kefauver-Harris Amendments to the FDA Act that was in 1962. There was a drug that was not yet approved by the FDA, thalidomide, which was being given out to women, prescribed by doctors without them telling them it was experimental, for pregnancy nausea of pregnancy. And it caused terrible birth defects. So Congress swung into action, they said, “Okay, from this point forward, not only are we tightening up the safety requirements, but we’re now going to require that you prove that the drug works, that it has efficacy.” Now what that has to do with giving a non-approved drug to people that cause birth defects, efficacy—it was very efficacious, it really worked well to prevent morning sickness. But so I don’t understand how they got to that spot.

But all doctors do and in medical science does, if you look at medical journals and go to medical meetings, that’s all we do is talk about efficacy, the efficacy of this drug versus that drug for the treatment of whatever. So by the FDA requiring these trials, these clinical trials that we’re hearing about now for example with drugs for COVID, it takes on average now 12 years and about $500 billion to bring a drug to market. And once it is approved as having efficacy for let’s say condition A, because when you file out your new drug application you have to tell the FDA what you want it to be used for, so once the FDA says it is approved for use for condition A, as far as the FDA is concerned, they trust clinicians to use their knowledge of the research and the clinical data they’ve seen to prescribe it for anything else, condition B through Z. So they determine based upon what they think is the efficacy. So of course it begs the question, if I had to why did I have to wait 12 years for you to tell me I can prescribe it for condition A when once you tell me that you don’t care if I prescribe it for B through Z because you trust my judgment? Why didn’t you just trust my judgment in the first place?

Bob Zadek: Jeff, I need to interrupt to give one final reminder to our listeners. Jeff’s paper, his white paper, is Drug Reformation: End Government’s Power to Require Prescriptions. It’s available at cato.org. It is interactive, you will enjoy reading it, you will learn a ton, and you will rethink your entire position on how much you need prescriptions to protect you from yourself. Jeff, thank you so much for the work on the paper. Thanks to our friend Michael Cannon as well, and thanks for your contribution this morning, Jeff. Have a good rest of the weekend.

Dr. Jeff Singer: Thank you, you too. It’s at cato.org/drugreformation. Thank you.

Bob Zadek: Thanks a lot, Jeff, and thanks to our friends out there for giving us an hour of your time.

Show prep notes

Bob’s own preparation for this episode.

11/22 - Jeff Singer on Legalizing Prescription Drugs

11/22 - Jeff Singer on Legalizing Prescription Drugs 1

Background 2

INTRO: 2

Pre‐1938 3

The Durham‐Humphrey Amendment of 1951 4

Kefauver Harris 4

Blocking Access to Safe, Necessary Drugs 5

Blocking Access to Life‐Saving Naloxone 5

Price Increases 6

Suggestions 6

Links: 6

Related Shows: 6

BLURB:

The libertarian argument for the right of bodily autonomy is simple. We own our bodies. Therefore, we should have the right to put whatever we choose into them.

Until the 20th century, this was taken for granted. But as Singer and Cannon lay out in their expansive new white paper on ending government’s power to require prescriptions, this right has been gradually eroded.

[Drug Reformation: End Government’s Power to Require Prescriptions by Jeff Singer and Michael F. Cannon, White Paper, The Cato Institute [Oct. 20, 2020]

The result is a more dangerous world, where consumers rely on untrustworthy institutions that restrict their choice and bypass more secure market mechanisms for determining safety and efficacy. Prescription drug companies rake in profits from their privileged legal status, and consumers suffer.

How did we get here? Tune in Sunday, as Jeff “@Dr4Liberty” Singer returns to the show to break down his recommendations for reforming a broken system.

Join our conversation live this Sunday (11/22), at 8am PACIFIC time. As always, your calls are welcome.

Phone (cell): (planning call Saturday at 11am PT or anytime Saturday)

Phone (landline):

Jeff Singer - BIO:

Jeffrey A. Singer is a Senior Fellow at the Cato Institute and works in the Department of Health Policy Studies. He is principal and founder of Valley Surgical Clinics, Ltd., the largest and oldest group private surgical practice in Arizona. He was integrally involved in the creation and passage of the Arizona Health Care Freedom Act, and served as treasurer of the US Health Freedom Coalition, which promotes state constitutional protections of freedom of choice in health care decisions. He was a regular contributor to Arizona Medicine, the journal of the Arizona Medical Association from 1994-2016. He also served on the Advisory Board Council of the Center for Political Thought and Leadership at Arizona State University from 2014-2018, and is an adjunct instructor in the Program on Political History and Leadership at ASU. He writes and speaks extensively on regional and national public policy, with a specific focus on the areas of health care policy and the harmful effects of drug prohibition. He received his B.A. from Brooklyn College (CUNY) and his M.D. from New York Medical College. He is a Fellow of the American College of Surgeons.

#CatoHealth

INTRO:

Government‐imposed prescription requirements violate the rights of individuals to access the medicines they want.

…

Congress should deny the FDA any power to impose prescription requirements. Doing so would not end prescription requirements. The threat of tort liability would push pharmaceutical manufacturers to require authorization from a physician or other competent medical professional before consumers could purchase unusually dangerous drugs.

…The evidence suggests that eliminating government‐imposed prescription requirements would lead to more‐judicious use of pharmaceuticals because consumers make more‐cautious drug decisions when the choice is theirs rather than when government forces them to consult physicians.

…

President Trump has claimed that pharmaceutical manufacturers are “getting away with murder.” His administration has unveiled several minor proposals mainly aimed at increasing price competition and accelerating the approval of generic drugs.5 While somewhat palliative, the proposals would leave the United States’ costly pharmaceutical regulatory regime fundamentally unaltered.6 Improving consumer access to pharmaceuticals requires fundamentally rethinking pharmaceutical regulation.

…

Congress should repeal Durham‐Humphrey and amend federal law to deny the FDA any power to impose prescription requirements. This would not end prescription requirements.

…

For decades, the medical profession resisted the doctrine of informed consent and the underlying goal of medical autonomy. Even into the 1970s, many doctors admitted to withholding terminal cancer diagnoses from their patients

Pre‐1938

Prior to 1938, federal law generally respected the right of individuals to self‐medicate. With narrow exceptions such as the Harrison Narcotics Act of 1914, which required prescriptions for narcotics that exceeded allowable limits, there were no federal requirements that consumers obtain a prescription from a physician before purchasing a drug. “The status of a drug as prescription or nonprescription was left entirely to the manufacturer,” noted former FDA general counsel Peter Barton Hutt.

Early laws under FDCA required labelling for over-the-couter products, resulting in unintended consequences:

[M]anufacturers of certain dangerous drugs were taking steps to protect consumers from them by labeling such drugs for, and marketing them exclusively to, physicians who would then prescribe them to patients. The FDCA exposed consumers to greater harm by requiring such manufacturers to affix to those drugs a label with instructions for lay use.

Manufacturers reasonably argued that forcing them to label such drugs for consumer use could make consumers less safe by misleading them to believe that they could use the drugs without physician supervision and could thereby expose manufacturers to liability.34

…

Classifying or reclassifying drugs as prescription‐only was likely attractive to drug manufacturers because it allowed them to charge higher prices (see the “A Contributor to Excessive Drug Prices” section), sidestep extremely costly labeling requirements, and avoid enforcement actions by an agency that provided almost no guidance as to how to proceed.

The Durham‐Humphrey Amendment of 1951

The Durham‐Humphrey Amendment formally authorized the FDA to classify pharmaceuticals as either over‐the‐counter (OTC) or prescription‐only. The amendment prohibits dispensing a prescription‐only drug unless the consumer presents a prescription from a government‐licensed health care practitioner. Manufacturers can request OTC or prescription‐only classification when submitting a new drug application, but the FDA makes the ultimate decision.

…

The Durham‐Humphrey Amendment formally authorized the FDA to classify pharmaceuticals as either over‐the‐counter (OTC) or prescription‐only. The amendment prohibits dispensing a prescription‐only drug unless the consumer presents a prescription from a government‐licensed health care practitioner. Manufacturers can request OTC or prescription‐only classification when submitting a new drug application, but the FDA makes the ultimate decision.

…

Whereas the FDA’s interpretation of the FDCA implicitly coerced manufacturers into marketing many drugs as prescription‐only, Durham‐Humphrey explicitly denied drug manufacturers the right to decide whether consumers must consult with a clinician before accessing a drug and the right to decide from what type of clinician consumers must obtain a prescription. It therefore also gave the FDA the power to deny consumers the right to choose whether to self‐medicate or to medicate under the direction of a clinician.

Kefauver Harris

…Among the most significant changes were the Kefauver‐Harris Amendments of 1962. These amendments exacerbated the effects of the Durham‐Humphrey Amendment’s government‐imposed prescription requirements.

Like the FDCA that they amended, the Kefauver‐Harris Amendments were a response to a tragedy involving unsafe drugs. In recent decades, the FDA has approved the drug thalidomide to treat leprosy and multiple myeloma

…

Imposing a proof‐of‐efficacy requirement before manufacturers can take a new drug to market was a curious response to the thalidomide tragedy. The concern with thalidomide was not its efficacy. It is indeed effective as a sedative—and in treating nausea associated with pregnancy for that matter. The issue with thalidomide was safety, and the FDA already had sufficient authority to keep it off the market until it was proven safe, as the agency’s handling of the drug demonstrates.

;

…

Kefauver‐Harris created the twin problems of “drug lag” and “drug loss.”

Since the Food and Drug Administration (FDA) Amendments of 1962, the average time from a drug’s first worldwide patent application to its approval by the FDA has risen from 3.5 to 13.5 years.…

Drug loss occurs when pharmaceutical manufacturers choose not to invest in finding new treatments that they do not believe can recoup the considerable cost of securing FDA approval.

…results suggest, again, that the FDA’s approval processes are so burdensome that, at the margin, they are harming health rather than improving health and that lowering the barriers to new drugs would improve overall health.

VIDEO: “…Now Without Prescription”

Blocking Access to Safe, Necessary Drugs

Examples of Plan B and Anti-Histamines.

A 2013 study in the journal Contraception found that oral contraceptives are available without a prescription in more than 100 countries.

Blocking Access to Life‐Saving Naloxone

The need for naloxone is dire. The U.S. Centers for Disease Control and Prevention (CDC) reports that from 1999 through 2017, nearly 400,000 U.S. residents died from opioid overdoses. Opioids account for more than two‐thirds of total drug‐overdose deaths, and mortality from opioid overdoses continues to rise.121

…

6/21 - Jeff Singer interprets “the Spike” and the Trade-offs surrounding COVID-19

6/21 - Jeff Singer interprets “the Spike” and the Trade-offs surrounding COVID-19 1

Topics 2

FDA/CDC screw ups 2

Regulatory obstacles to testing/drugs 2

The unsettled debate regarding hydroxychloroquine vs patients’/physicians’ rights 2

How licensing laws, Certificate of Need Laws, and scope of practice laws have encumbered our response—made us clumsy and flat-footed 3

How lockdowns have TRADE-OFFS—the seen vs the unseen—and how giving too much decision power to one authority creates incentives that lead to over-reaction 3

How the COVID-19 strategy should be focused on HARM REDUCTION, and protecting the vulnerable, but should not be based on any false notion that this virus will ever go away—it is here to stay, and will menace us until we achieve herd immunity. 7

BLURB 7

Links: 7

Related Shows: 7

Phone (cell): (planning call Saturday at 11am PT or anytime Saturday)

Phone (landline):

Jeff Singer - BIO:

Facebook (author)

Tags: #CatoCOVID @CatoEvents

@Dr4Liberty

Topics

FDA/CDC screw ups

Regulatory obstacles to testing/drugs

COVID-19 and the Right to Test | Cato Institute (June 8) Video panel featuring Jessica Flanigan, Roger Klein, and Michael F. Cannon - “A Columbia University study estimates that imposing social‐distancing measures one week earlier would have saved 36,000 lives. If so, then the Food and Drug Administration’s (FDA) decision to block reliable SARS‐CoV‐2 diagnostic tests for nearly two months could easily have cost twice as many lives. Rather than speed diagnostic tests to market, the FDA created additional barriers to entry that proved not only unnecessary but deadly.” @missjessica, @mfcannon, @RogerDKlein.

My Coronavirus Tale | Cato @ Liberty

Jeff tested positive although was asymptomatic. His wife tested negative, suggesting asymptomatic people are not as contagious. Good news given the number of new positive tests coming out.

The unsettled debate regarding hydroxychloroquine vs patients’/physicians’ rights

The Real Problem With Hydroxychloroquine Is Nothing New. It’s Chemistry. | American Council on Science and Health, May 20, 2020

Main concern about HCQ is cardiac toxicity. It disrupts one of the channels responsible for regulating the electrical current that drives heartbeat.

“Last I heard, voltage-gated ion channels do not register for primaries, and they vote only infrequently. We are talking about the binding of a drug (or any other molecule) to a channel whose job is to keep ions moving in and out of a cell in such a way that your heart beats properly. Not anything that should be part of a presidential campaign. It should be “torsades de pointes,” not “talking de points.” In other words, real science.”

How licensing laws, Certificate of Need Laws, and scope of practice laws have encumbered our response—made us clumsy and flat-footed

Coronavirus: Medical-Licensing Laws Need Reform | National Review by Jeffrey Singer and Richard Menger May 29, 2020

Organized medicine has created an artificial shortage of physicians.

If the many lessons of the COVID-19 pandemic, one of the most obvious is the need to reevaluate state-licensing laws that impede the free and rapid movement of health-care workers to places they are needed. Many governors suspended state-licensing requirements in early March so that doctors, nurses, and other health-care professionals licensed in other states could help with the public-health crisis in their own states. These governors should not resume the ways of the past when the crisis ends.

Licensing laws exist to protect health-care provider interests.

AMA promotes state-licensing laws. Requirements are almost identical yet licenses are not transferable.

Private credentialing and certification organizations, such as the American Board of Surgery and the American Board of Neurological Surgery, do the vetting of practitioners’ training and competency that health-care consumers need when seeking medical advice. Health-care consumer-rating sites such as Healthgrades or Vitals rate health-care providers, while sites lsuch as Leapfrog or Consumer Reports rate health-care facilities. Licensing boards provide no such tangible function.

…

State license boards’ websites may be cumbersome to navigate. Consumers might find it a challenge to view and fully understand any out-of-state complaints a physician might have had prior to relocating in their state. Nobel Prize–winning economist Milton Friedman understood this when he criticized medical-licensing laws. The governance of physicians is best done closest to the physician at the hospital, group, or specialty certification level.

How lockdowns have TRADE-OFFS—the seen vs the unseen—and how giving too much decision power to one authority creates incentives that lead to over-reaction

Coronavirus lockdowns have obvious costs and unseen costs too Washington Examiner, June 4, 2020 by Jeff Singer

Sometimes governors have legitimate reasons to restrict activity during health crisis.

However, one-size-fits-all rules do more harm than good.

Jeff takes this as an argument for decentralization of power:

To be sure, onerous restrictions that lack a plausible rationale, such as bans on drive-in church services, have adverse consequences that are readily seen and unpopular. In such cases, the negative feedback is an incentive for officials to lift such restrictions. But far too often, it’s the other way around. The disparity between what is seen and what is not seen means that government officials have incentives to be overly cautious and impose more restrictions for longer lengths of time than what may really be necessary. That’s why it is important to minimize the amount of decision-making authority vested in just one person.

‘\ …

On all levels of government, one-size-fits-all measures should be kept to a minimum, and civil society should be informed, guided, and entrusted to work out suitable solutions.

John Ioannidis on the overreaction:

“We now know that the death toll is not comparable to that of the 1918 pandemic. We also now know that the virus has spread widely, but for the vast majority of people it is far less lethal than we thought: it kills far fewer than 3.4 percent of those who develop symptoms. Late last week the CDC adopted an estimated death rate of 0.4 percent for those who develop symptoms and acknowledged that there are many other infected people who develop no symptoms at all. These estimates will continue to improve as time goes on, but it is clear that the numbers are much lower than first feared.”

Makes an analogy: we do not continue to treat non-critical patients as aggressively as we do when there’s a real emergency because the treatment might kill them (i.e., continuing CPR after you’ve broken their ribs - you might puncture a lung). Examples of collateral damage in the COVID analogy:

“We know that prolonged lockdown of the entire population has delayed cancer treatments and has made people with serious disease like heart attacks avoid going to the hospital. It is leading hospital systems to furlough and lay off personnel, it is devastating mental health, it is increasing domestic violence and child abuse, and it has added at least 36.5 million new people to the ranks of the unemployed in the United States alone. Many of these people will lose health insurance, putting them at further risk of declining health and economic distress. Prolonged unemployment is estimated to lead to an extra 75,000 deaths of despair) in the United States alone over the coming decade. At a global level, disruption has increased the number of people at risk of starvation to more than a billion, suspension of mass vaccination campaigns is posing a threat of resurgence of infectious diseases that kill children, modeling suggests an excess of 1.4 million deaths from tuberculosis by 2025, and a doubling of the death toll from malaria in 2020 is expected compared with 2018. I hope these modeling predictions turn out to be as wrong as several COVID-19 modeling predictions have, but they may not. All of these impacts matter, too. Policymakers must consider the harms of restrictive policies, not just their benefits.”

7/14/19 - Jeff Singer: The “Doctor for Liberty” on Opioid Abuse, Harm Reduction, and ObamaCare

7/14 - Jeff Singer: The “Doctor for Liberty” on Opioid Abuse, Harm Reduction, and ObamaCare 1

Videos & Multi-Media 2

BLURB 2

Harm Reduction 3

Opioids 3

ObamaCare Challenge 4

Links: 6

Related Shows: 6

Phone (cell):

Phone (landline):

Jeff Singer - BIO:

Jeffrey A. Singer is a Senior Fellow at the Cato Institute and works in the the Department of Health Policy Studies. He is principal and founder of Valley Surgical Clinics, Ltd., the largest and oldest group private surgical practice in Arizona. He was integrally involved in the creation and passage of the Arizona Health Care Freedom Act, and served as treasurer of the US Health Freedom Coalition, which promotes state constitutional protections of freedom of choice in health care decisions. He was a regular contributor to Arizona Medicine, the journal of the Arizona Medical Association from 1994-2016. He also served on the Advisory Board Council of the Center for Political Thought and Leadership at Arizona State University from 2014-2018, and is an adjunct instructor in the Program on Political History and Leadership at ASU. He writes and speaks extensively on regional and national public policy, with a specific focus on the areas of health care policy and the harmful effects of drug prohibition. He received his B.A. from Brooklyn College (CUNY) and his M.D. from New York Medical College. He is a Fellow of the American College of Surgeons.

Facebook (author)

Tags: Opioid Crisis, ObamaCare, HarmReduction Drug War

Twitter accounts:

Best accounts to follow on healthcare and #WaronDrugs

@GoldwaterInst

@CatoHealth

@TNREthx

@jeffreyamiron

@DavidSFink

@_DrScott_

@DanCiccarone

@JacobSullum

@MfCannon

And of course, @Dr4Liberty

Videos & Multi-Media

Cato Panel:

Harm Reduction: Shifting from a War on Drugs to a War on Drug-Related Deaths | Cato Institute - A day of discussion featuring opening comments from Jeff Singer.

Unlike prohibition, harm-reduction strategies begin with the realistic and nonjudgmental premise that there has never been, and will never be, a drug-free society. Akin to the credo of the medical profession — “First, do no harm” — harm reduction seeks to avoid measures that exacerbate the harm that prohibition already inflicts on nonmedical users and seeks to focus on the goal of reducing deaths and the spread of disease from drug use.

Harm reduction policies include safe injection sites, heroin-assisted treatment for addicts, take home opioid prescriptions like Naxalone, needle exchange programs, etc.

“Ninety-three years after Congress banned the manufacture, distribution, sale, and possession of heroin, and 48 years after President Richard Nixon declared a “war on drugs,” drug prohibition has proved a failure. People are dying largely because of drug prohibition. Evidence continues to mount that curtailing prescription opioid availability only serves to drive nonmedical users to heroin, with increasing numbers of nonmedical users initiating their opioid abuse with that substance.”

BLURB

We will never live in a drug free world.

Listen in Sunday for the still, small voice of liberty, and call in to speak with Robby at any time (8–9am PACIFIC).

Harm Reduction

Studies:

New Evidence From British Columbia Provides a Strong Case for Harm Reduction Strategies | Cato @ Liberty

Vancouver has been successfully experimenting with harm reduction strategies:

“During the 23 months ending December 2017 there were 2,177 overdose deaths in British Columbia, according to the British Columbia Centre for Disease Control. Using mathematical modeling methodology to estimate monthly overdose and overdose-death risk along with the impact of harm reduction interventions, the researchers concluded an estimated 3,030 overdose deaths were averted.

…

Efforts to approach this problem by doubling down on supply-side interventions and the War on Drugs are doomed to fail—and will only cause more people to die. Fighting a war on drugs is like playing a game of “Whac-a-Mole.”

If the British Columbia experience should teach policymakers anything, it should be that harm reduction is the most effective way to end the overdose crisis. Ending prohibition would be the most consequential form of harm reduction.”

Opioids

(PDF) Today’s nonmedical opioid users are not yesterday’s patients; implications of data indicating stable rates of nonmedical use and pain reliever use disorder

According to the narrative underlying current policies aimed at reducing opioid-related deaths, the problem can be traced to a dramatic increase in opioid prescribing that began in the late 1990s. This trend supposedly was fueled by unscrupulous pharmaceutical company representatives who convinced practitioners that opioids posed a low risk of misuse and overdose (although a recent analysis1 suggests there were probably 30 or more root causes of the crisis). To illustrate this narrative, politicians and journalists have cited examples of patients who accidentally became “hooked” on opioids while taking them for pain, such as teenagers with orthopedic injuries who found the analgesics prescribed for them so alluring that they progressed to lives of drug abuse and addiction.2 This narrative drives policies targeting the prescription of opioids to patients in pain, with the goal of reducing the risk of addiction as well as the diversion of prescription opioids to the underground market. These policies include state prescription drug monitoring programs (PDMPs), abuse-deterrent formulations of prescription opioids, prescribing guidelines, and legal restrictions on prescribing for both acute and chronic pain.

Scapegoating Opioid Makers Lets True Offender Get Away | Cato Institute

At the end of the day, the drug overdose problem is the result of sociocultural dynamics intersecting with drug prohibition — and all the dangers that a black market in drugs present. Prohibition also presents powerful incentivesto corrupt doctors, pharmacists and pharmaceutical representatives who seek the profits offered by the underground trade.

When Portugal decriminalized all drugs in 2001, it saw a 75 percent drop in its population of heroin addicts by 2015, and now has the lowest overdose rate in Europe, at 6 per million population (compared to 312 per million in the United States). Along with Portugal, most of the developed world has put an emphasis on harm reduction strategies over restrictionist, prohibitionist approaches, one reason they have lower death rates than the United States. These strategies include medication-assisted treatment with drugs like methadone and buprenorphine; safe injection facilities; needle-exchange programs; and making the overdose antidote naloxone more available.

Abuse-Deterrent Opioids and the Law of Unintended Consequences | Cato Institute

ObamaCare Challenge

Long-shot legal challenge could end Obamacare during the 2020 campaign - POLITICO 7.8.19 by Paul Demko

“The court will hear oral arguments on whether the Affordable Care Act is no longer valid after Congress eliminated the tax penalty for not purchasing health insurance. The lawsuit, brought by 18 Republican-led states, could jeopardize health care coverage for more than 20 million people insured through the 2010 health care law, eliminate insurance protections for preexisting conditions, and severely disrupt the country’s $3.5 trillion health care system.

…

They argue that Congress’ decision to scrap the individual mandate penalty in 2017 rendered the law unconstitutional because the Supreme Court previously upheld the mandate as a valid exercise of taxing power.

…

If the appeals court reverses the judge’s decision and finds the ACA is constitutional, the red states and the Trump administration could appeal the decision to the Supreme Court, which again could determine the law’s fate. In previous major cases, the court narrowly saved the individual mandate in 2012, and in 2015 it upheld the law’s premium subsidies in a 6-3 decision.

“Judge O’Connor is not going to get to decide the constitutionality of the ACA — either in the red states or nationwide — without some kind of Supreme Court review,” said Nicholas Bagley, a University of Michigan Law School professor who’s written extensively about the case. “By hook or by crook, the Supreme Court will get the case.”

The ACA has remained in effect since the judge found it unconstitutional, and the Trump administration has said it will enforce it while the lawsuit winds through the courts. Meanwhile, the law’s insurance marketplaces have largely stabilized after a few rocky years. Enrollment has decreased slightly and many insurers are turning a profit, despite the elimination of the individual mandate penalty.”

Suit to Destroy Obamacare Slouches Towards Supreme Court

“If you buy the popular hypothesis that Chief Justice John Roberts is worried about the Supreme Court appearing too “political” or “partisan,” you have to figure he’s suffering from some heartburn this week. That’s because the most politically inflammatory and blatantly partisan lawsuit in recent memory appears to be a step closer to forcing itself onto the docket of the high Court. Li Zhou has the quick explanation for Vox:

The Affordable Care Act is being challenged in the courts yet again — and a Fifth Circuit decision could help determine whether that fight winds up going any further.

(424) BOB-SHOW // (424) 262-7469

Planning Call: Friday morning

Live Show: (home)

Show Notes:

Headline: Opioids and the Agony of the American Health Care Act, with Dr. Jeff Singer

Ronald Reagan once quipped that the 9 most terrifying words are “I’m from the Government and I’m here to help.” With the Trump administration’s recent announcement of its plan to crack down on the pain pill epidemic, we may soon grow to fear the words “I’m from the federal opioid commission, and I’m here to help.” Meanwhile, the Republicans first stab at repealing and replacing Obamacare revealed a fundamental lack of seriousness. The failed American Health Care Act retained the central mandates from Obamacare that are leading to the “death spiral” of growing costs and shrinking options for insurance customers. If all of this bad news is giving you a headache, you’ll want to be sure to tune in to this Sunday’s show. Dr. Jeffrey Singer, a general surgeon and regular guest on The Bob Zadek Show, will help Bob dissect the unintended consequences of government intervention in the sacred relationship between doctor and patient. In Arizona, where Dr. Singer practices, limits on prescription pain medication have already made it harder to optimally assist patients recovering from surgery. As government takes over greater control of the healthcare industry, we can expect less of a role for doctor discretion, and more decisions being made by bureaucrats without our best interests in mind. Listen, learn, and call in with your questions and comments for Bob and Dr. Singer at any time during the show (424) BOB-SHOW.

>> Tune in to the Answer: SF Bay Area: 860AM // Sacramento: 1380AM // Seattle: 1590AM

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Listen LIVE - 8-9 AM PACIFIC, on 860 AM - The Answer, or Streaming LIVE online

Links

Harm Reduction an Alternative to Incoherent Opioid Addiction Policies, Reason.com, by Jeff Singer, April 19, 2017
Arizona’s Misguided War on Opioids, Reason.com, by Jeff Singer, November 7, 2016
The Failures of the American Health Care Act, Reason.com, by Jeff Singer, March 19, 2017
@Dr4Liberty on Twitter

Related Shows (Subscribe to the Podcast):

Dr. Jeffrey A. Singer on Electronic Health Records, April 12, 2015
Would You Want Obama to Be Your Doctor? He Already Is, January 19, 2014, with Jeff Singer
Will Americans Accept Second Class Medicine?, September 15, 2013 with Jeff Singer
Obamacare and The Loss of America, March 28, 2010 (no guest)
Ethics and Economic Freedom vs Healthcare, February 28, 2010, with Bruce Fagel
Oral Roberts Meets Dr. Welby, December 20, 2009 with Edward Hudgins

[BIO]

Adjunct Scholar at the Cato Institute
General Surgeon in Phoenix, AZ
Principal and founder of Valley Surgical Clinics, Ltd., the largest and oldest group private surgical practice in Arizona.
Was involved in the passage of the Arizona Health Care Freedom Act
Serves as treasurer of the US Health Freedom Coalition, which promotes state constitutional protections of freedom of choice in health care decisions.
He is a regular contributor to Arizona Medicine, the journal of the Arizona Medical Association. He writes and speaks extensively on regional and national public policy, with a specific focus on the areas of health care policy and the harmful effects of drug prohibition.

FIND HER WORK AT:

New co-authored book Unequal: How America’s Courts Undermine Discrimination Law (Oxford Univ. Press May 2017)
Twitter: @sujathomas3

On this Day in History: 4/30

Summary:

The Missing American Jury: Restoring the Fundamental Constitutional Role of the Criminal, Civil, and Grand Juries

Links:

Book talk, May 5, 2017 – short article linking book to recent.

The Myth of the American Jury, Summer 2016, International Judicial Monitor

Short animated TED-Ed video about the book subject (4 minutes)

Reviews about the book

Podcasts and media about the book

Three Additional Topics

1. Revised Immigration Ban [Updated]

Two federal courts rule against Trump’s revised travel ban By Ilya Somin March 16

VIDEO - Trump’s revised travel ban is still cruel and still unconstitutional - The Washington Post by Ilya Somin, March 6, 2017

The new order is less bad than the old one in some crucial respects. But it is still indefensibly cruel, and still unconstitutional for many of the same reasons as the original.

Like the original order, the new one is still clearly an outgrowth of Trump’s advocacy of a “Muslim ban,” as admitted by Trump adviser Rudy Giuliani, who played a key role in drafting the first order.

The Trump administration will continue to argue that the courts should defer to its policy and not scrutinize it closely because of the so-called “plenary power” over immigration.

The Plenary Powers doctrine:

Article II grants the President all executive power, including the conduct of foreign policy. To the extent Article I grants Congress power over foreign travel into the United States, that body has also granted the President nearly total discretion to stay foreign travel to advance national security. Historically, wartime presidents routinely stay travel from enemy and enemy controlled nations for obvious reasons. Trump’s stay is no different.”

Why Trump’s refugee order is unconstitutional by Ilya Somin, February 5, 2017

Violates equal protection clause by targeting Muslims – here Trump’s statement, calling it a “Muslim Ban,” serves as the evidence for a discriminatory motive.

“A federal court recently enjoined Donald Trump’s executive order barring refugees and migrants from seven Muslim-majority nations. One of the main issues at stake in the growing legal battle over the order is whether the order qualifies as unconstitutional discrimination against Muslims. Despite a thin veneer of religious neutrality, the order does in fact target Muslims….

…the unconstitutional motive behind Trump’s order can’t be sidestepped by pointing out that it blocks some non-Muslim refugees too. Poll taxes and literacy tests excluded a good many poor whites from the franchise, but were still clearly aimed at blacks. Just as the exclusion of some white voters was collateral damage from southern states’ efforts to target African-Americans, so the exclusion of Syrian Christian refugees is tragic collateral damage from Trump’s efforts to target Muslims.”

“The text does limit a few specific constitutional rights to American citizens, such as those protected by the Privileges or Immunities Clause of the Fourteenth Amendment. But this only underscores the fact that other constitutional rights extend to everyone. There would be no need to explicitly limit some rights to citizens if there were a general presumption that non-citizens are excluded.

Moreover, most of the rights enumerated in the Constitution are stated as generalized limitations on government power, not as privileges reserved to some specific group of people, such as American citizens or permanent residents. That is certainly true of the religious Free Exercise Clause of the First Amendment, the Equal Protection Clause of the Fourteenth Amendment, and the Due Process Clause of the Fifth Amendment, the three provisions at issue in the litigation over Trump’s order (the text of the Equal Protection Clause seems to limit its application to state governments, but the Court has long held that it restricts the federal government too). It is highly questionable whether the original meaning gives the federal government any general power to restrict immigration at all, much less one so sweeping that it overrides individual rights that restrict every other type of government action.

2. Syria Gas Attack: Assad’s Doing or False Flag?

Ron Paul argues that the gas attack could be more to the advantage of warmongers, rather than Assad, who would essentially be committing suicide.

3. Trump : Twitter :: Roosevelt : Radio

FDR’s War Against the Press 4/5/17, Reason, by David Beito

Extended analogy between Trump and FDR in terms of their views on the media, and use of new media to go straight to voters:

“In very Trumpian language, Roosevelt praised the new media for restoring “direct contact between the masses and their chosen leaders.” As the media historian Betty Houchin Winfield notes, radio allowed the president to be “the news gatherer, the reporter, as well as the editor,” all at the same time.”

Like Trump, he singled out some reporters who wanted to ask questions and ignored others. Writing for The Washington Post in 1938, Harlan Miller commented that Roosevelt only answered questions which enabled him to “utter an oral editorial.…He selects only those on which he can ring the bell.”

Related Shows: 1

Not a Prescription Opioid Crisis 2

For fun 5

Miron vs. Sessions on the Drug War, July 9, 2017

Opioids and the Agony of the American Health Care Act, April 30, 2017

Dr. Jeffrey Singer on Gary Johnson vs. The Lesser of Two Evils, August 07, 2016

Will Americans Accept Second Class Medicine?, September 15, 2013

Would You Want Obama to Be Your Doctor? He Already Is, January 19, 2014

SUNDAY:

[BIO] Cato Institute Adjunct Scholar:

Jeffrey A. Singer is a general surgeon in private practice in metropolitan Phoenix, AZ. He is principal and founder of Valley Surgical Clinics, Ltd., the largest and oldest group private surgical practice in Arizona. He was integrally involved in the creation and passage of the Arizona Health Care Freedom Act, and serves as treasurer of the US Health Freedom Coalition, which promotes state constitutional protections of freedom of choice in health care decisions. He is a regular contributor to Arizona Medicine, the journal of the Arizona Medical Association. He writes and speaks extensively on regional and national public policy, with a specific focus on the areas of health care policy and the harmful effects of drug prohibition. He received his B.A. from Brooklyn College (CUNY) and his M.D. from New York Medical College. He is a Fellow of the American College of Surgeons.

Direct listeners to Cato, Reason, @Dr4Liberty

BLURB:

Dr. Jeffrey A. Singer – aka the “Doctor For Liberty” – recently wrote a piece for Cato @ Liberty in which he challenged the mainstream media narrative about the abuse of prescription pain pills. The Trump administration is cracking down on doctors and requiring them to jump through hoops to give their patients necessary medication. So much unnecessary pain will be caused in the name of staunching the opioid epidemic, which turns out not to be an opioid epidemic after all. The War on Drugs remains what it has always been – a war on people. The substances change (today, for example, we have the highly dangerous and addictive Fentanyl being illegally smuggled from Chinese factories) but the game stays the same. Policies are enacted that hurt those they are supposed to help, and experienced professionals (i.e., doctors) are prevented from using their best judgment. Singer says we don’t need more funding for the epidemic, we need more rationality and calm assessment of the data, which suggests that restricting supply of prescription opioids is pushing people to black markets and creating more addicts, not fewer. Instead of facts, we get hysteria. Dr. Singer returns to the show to discuss America’s longest war for the full hour with Bob. Call in to (424) BOB-SHOW to speak with Bob and Jeff at any time.

Not a Prescription Opioid Crisis

The War on Opioids Has Become a War on Patients | Cato @ Liberty

March 12, 2018

Doctors’ prescriptions are not closely linked to opioid addictions and deaths, yet the DEA is still putting pressure on doctors to prescribe fewer opioids.

When doctors are intimidated into curtailing their patients supply of pain killers, the patients are more likely to go to the black market and become hooked:

As prescriptions continue to decrease, overdose deaths continue to increase. This is because as non-medical users get reduced access to usable diverted prescription opioids, they migrate to more dangerous fentanyl and heroin.

…

The “war on opioids” being waged by today’s policymakers is, in effect, a “war on patients in pain.” If policymakers are serious about wanting to reduce overdose deaths, they should look to what has been done in Portugal, and now Norway, and end the war on drugs. If they can’t muster the political will to go that far, then they should at least put the focus on harm reduction measures, such as syringe services programs, medication-assisted treatment, and making the overdose antidote naloxone available over-the-counter.

Fentanyl (synthetic opioids) overdoses increase 540% in the 3 years leading up to 2015.

Stop Calling it an Opioid Crisis—It’s a Heroin and Fentanyl Crisis | Cato @ Liberty

January 9, 2018

There was a 25 % reduction in 2017 and a 20% reduction is ordered for 2018.

Data from the Centers for Disease Control and Prevention show that from 2006 to 2010 the opioid prescription rate tracked closely with the opioid overdose rate, at roughly 1 overdose for every 13,000 prescriptions. Then, after 2010, when the prescription rate dropped and it became more difficult to divert opioids for nonmedical use, the overdose rate began to climb as nonmedical users switched over to heroin and fentanyl. There is a dramatic negative correlation between prescription rate to overdose rate of -0.99 since 2010.

Let’s Stop the Hysterical Rhetoric About the Opioid Crisis - Jeffrey Singer - townhall.com

Aug. 31, 2017

Harm Reduction works better than stricter monitoring of prescriptions and criminal penalties for addicts.

Not all solutions are created equal. States have made the opioid antidote naloxone more available to chronic pain patients and to first responders. And more money is being spent on rehab programs. But so far most proposals for dealing with the overdose problem focus on increased surveillance on patients and providers, inducing doctors to prescribe fewer opioids, and making manufacturers cut back on the amount of opioids produced.

…

If policy makers in the Trump administration want to effectively address the problem, there are other ways to do it. They should promote “harm reduction” programs, including pilot “heroin maintenance” programs, such as those that have worked successfully in Switzerland, the UK, Germany, the Netherlands, and Canada. They should also take note of recent evidence from Johns Hopkins University, the University of Michigan, and the RAND Corporation that have shown a dramatic decrease in opioid use and overdose rates in states that have legalized marijuana for medicinal use.

Jeffrey A. Singer discusses the opioid crisis on BBC News | Cato Institute

Oct. 27, 2017

Singer says we don’t need more funding for the epidemic, we need more rationality and calm assessment of the data.

Instead we get hysteria.

The BBC host is shocked that the narrative he’s been told is not backed up by the numbers.

Heroin and fentanyl are overtaking opioids as doctors are forced to curtail prescription opioids.

Singer says the real reasons are multi-factorial and socio-cultural – people being out of work, etc. You can’t address these issues by clamping down on supply.

The death penalty for drug dealers is a terrible idea. It’s also apparently the White House’s new opioid strategy. - Vox, March 16, 2018

Trump is sounding a lot like the Filipino dictator Rodrigo Duterte

Killing drug dealers has become a Trump fixation. It’s an idea he seems to have picked up from governments in Southeast Asia — including the Philippines, whose president, Rodrigo Duterte, has overseen mass vigilante killings of alleged drug dealers and users. For the past few weeks, reports indicate that he’s continually brought it up in meetings with advisers and members of Congress — sometimes jokingly and sometimes not so jokingly.

The law could begin treating opioid overdose as a form of homicide by the last person to touch the substance before the person overdosed.

The Florida state legislature passed a law last year allowing prosecutors to file murder charges against heroin or fentanyl dealers after fatal overdoses — a charge that allows them to seek the death penalty.

How Drug Prohibition Caused the Opioid Crisis | Libertarianism.org

Prescription opioid abuse peaked in 2012. Total opioid abuse peaked in 2014, but heroine and fentanyl overdoses continue to rise, since demand for illegal products has increased as supply for legal medication has declined.

Drug prohibition is the source of rising fentanyl and heroin addictions.

Interesting discussion of the chilling effect on doctors. Monitoring agencies look at which doctors are outliers in terms of their prescriptions. So doctors cut back so as not be outliers, even if they just have a lot of patients (which explains their outlier status). Knowing that everyone else is cutting back, they must cut back even further.

Opioid Crisis: Efforts to Curtail Prescribing Are Backfiring | National Review

Oct. 25, 2017

For fun

AUDIO - Trainspotting clip - “I chose not to choose life.”

This clip plays into the myth about heroine being all-powerful. “Heroisch” in the originally German, because it was stronger than morphine and believed to be more corrupting to the morals.

Summary:

👉 The narrative that doctors are getting people hooked on opioids is a myth. Most people who are addicted and dying from overdoses are taking illegal fentanyl.

👉 Scapegoating the medical profession has lead to an inability to prescribe appropriate doses of painkillers post-operation, epitomized in the 2016 “guidance” by the CDC, which has been enshrined in law in many states.

Zadekpedia

Explorer

Dr. Jeff Singer on Prescription Drug Freedom

Introduction and the COVID-19 Test Prescription [00:00]

The History of the Prescription Requirement [03:55]

The Sulfanilamide Disaster and the 1938 Act [06:41]

The Durham-Humphrey Amendment of 1951 [09:30]

Safety, Autonomy, and the Knowledge Problem [12:05]

The Politicalization of Plan B [15:05]

International Comparisons and the Case for OTC Insulin [18:30]

Economic Consequences and Third-Party Payers [21:00]

The Efficacy Requirement and Drug Innovation [23:30]

Show prep notes

11/22 - Jeff Singer on Legalizing Prescription Drugs

INTRO:

Pre‐​1938

The Durham‐​Humphrey Amendment of 1951

Kefauver Harris

Blocking Access to Safe, Necessary Drugs

Blocking Access to Life‐​Saving Naloxone

6/21 - Jeff Singer interprets “the Spike” and the Trade-offs surrounding COVID-19

Topics

FDA/CDC screw ups

Regulatory obstacles to testing/drugs

The unsettled debate regarding hydroxychloroquine vs patients’/physicians’ rights

How licensing laws, Certificate of Need Laws, and scope of practice laws have encumbered our response—made us clumsy and flat-footed

How lockdowns have TRADE-OFFS—the seen vs the unseen—and how giving too much decision power to one authority creates incentives that lead to over-reaction

7/14/19 - Jeff Singer: The “Doctor for Liberty” on Opioid Abuse, Harm Reduction, and ObamaCare

Videos & Multi-Media

BLURB

Harm Reduction

Opioids

ObamaCare Challenge

Show Notes:

On this Day in History: 4/30

Summary:

Links:

Three Additional Topics

1. Revised Immigration Ban [Updated]

2. Syria Gas Attack: Assad’s Doing or False Flag?

3. Trump : Twitter :: Roosevelt : Radio

Related Shows:

Not a Prescription Opioid Crisis

For fun

Summary:

Table of Contents

Backlinks

Pre‐1938

The Durham‐Humphrey Amendment of 1951

Blocking Access to Life‐Saving Naloxone