Although I agree with much that is in the article by Prasad and Makary, I believe that people who want a COVID shot and are willing to pay for one with their own money should have access, regardless of the FDA's assessment of efficacy or safety. As Vinay has explained many times, the decision to have the shot is self-regarding. The shot …
Although I agree with much that is in the article by Prasad and Makary, I believe that people who want a COVID shot and are willing to pay for one with their own money should have access, regardless of the FDA's assessment of efficacy or safety. As Vinay has explained many times, the decision to have the shot is self-regarding. The shot ameliorates the severity of the symptoms. I think it is illegitimate, and beyond the government's normatively defensible role, for the the FDA to prevent people from accessing medicines whose effects are mainly self-regarding. Government exists to prevent people from harming others, not to tell us what we can and cannot do to/for ourselves. If people want the shots and are willing to bear the cost and consequences, the public has no normatively defesible role to play.
Don't worry, if you go pester enough doctors I am sure you can find one who will administer you as many Covid booster as your heart desires. The FDA isn't your doctor, but they are the people who should be evaluating the costs vs. benefits in different populations and I am glad to see them finally doing their jobs.
I don't want COVID boosters. There's no evidence that they help people like me, so why would I? I'm simply tired of public officials and ignorant voters whose values differ enormously from mine sticking their noses into my (and others') private affairs. And we do not need the FDA to assess the costs or benefits of medications or other medical treatments. Private regulators would do the job better and more quickly, and would be less susceptible to pressure from interest groups and interest conflicts. I'd take a pharma version of Consumer Reports over the FDA any day.
Forgot to mention that I also oppose the requirement of obtaining a doctor's permission to get a vaccine (or any other treatment for which an RX is required). In my opinion, doctors should be advisors and treatment providers. They should not be gatekeepers, except when patients want them to be. The combination of the FDA, which decides when RXs are required, and doctors, who charge fees for giving patients permission to access treatments, is a gross and unwarranted denial of the liberty to self-medicate. And, of course, I oppose the war on drugs.
I have the impression Charle’s ideas are widely practiced in many developing nations. If my impression is relatively accurate, is there reliable evidence that such a system tends to be helpful or harmful to the general populace?
A practical, common example is the individual that repeatedly gets antibiotic responsive UTIs multiple times a year with the same predictable symptoms & outcomes. Yet in the US that person needs a UA & MD to get 3-5 day course of cheap antibiotic.
I agree with every statement. In many years of medical practice, I never required a patient to come into the office to get a prescription and never charged for calling one in to the pharmacy. I would give them my advice and if they wanted to discuss it, they could make an appointment and we could talk about it. The only exception were drugs on the narcotic restricted list because that might cause revocation of my license. If it were up to me, any adult could buy any drug they like. For those who have a fear of freedom, I would ask "How has that war on drugs been working out for you over the last 50-60 years? By the way, in 40 years of practice I was never sued and never had any contact with government regulators.
I think you grossly overestimate the general population's ability to determine what is good for them. Your fantasy of personal liberty and freedom would greatly exacerbate the problem of drug companies marketing products to patients that they don't necessarily need. Just imagine if a person could order a medication after watching a commecial for it! Ha! The hospitals would be overwhelmed with overdoses and adverse drug interactions, a true medical wild-west nightmare.
I also don't see why a private regulator would be any less susceptible to corruption than a government one.
Consumers' inability to make intelligent choices is a problem in many areas of economic activity. It is also one that providers have incentives to address when they operate in competitive markets. They do this in many ways, such as by offering money-back guarantees, technical support, and obtaining certifications from independent testing agencies. Ever heard of automobile safety scores? I don't know which cars are safest, but I can easily find out because the Insurance Institute for Highway Safety publishes them. I don't know which cars are the most reliable, but I can find that out too by consulting Consumer Reports. I know little about the technical standards that products should comply with, but sellers make it easy for me to know that their products are properly designed by having them certified by Underwriters Labs (now UL Solutions). UL also certifies that manufacturing plants are up to snuff. These are all private regulators who help consumers make good choices. If we free consumers to buy what they want, these entities and others will do the same for drug purchases.
And, of course, consumers will be free to ask doctors for advice.
I suspect that you know little about private regulators. Have you ever studied, e.g., the role that liability insurers play in improving the quality of medical treatments? I have an article on the subject, coauthored with Prof. Tom Baker, one of the country's leading insurance scholars, in a symposium issue of the DePaul Law Review. https://via.library.depaul.edu/law-review/vol68/iss2/3/.
I also suspect that you've not studied the myriad ways in which markets facilitate intelligent shopping by consumers. I mentioned a couple above, but there are many more. E.g., markets force sellers to disclose prices--as LASIK and other retail health care providers do--and price information is critical for intelligent shopping. They also pressure sellers to track and provide quality information--as IVF providers do, they also being retail providers. Consumer ignorance is an enormous problem in the non-retail health care sector--where most doctors, hospitals, drug companies, and other provider operate--because the system is designed to prevent market forces from working, with the result that providers can make enormous sums while keeping patients in the dark.
In fact I think Sensible Medicine is the wrong audience for your ideas, you should start an organization called Patients for Medical and Health Freedom and start writing op-eds and lobbying Congress about making it easier for drug companies to sell their products directly to consumers without any regulatory oversight. I am sure you would have no shortage of drug companies willing to foot the bill for your new organization. Might even be quite lucrative.
I expect this sort of snarky comment from political partisans and ideologues. Can't deal with the argument on the merits, so attack the author by imputing financial motivations. Sad.
A bit snarky? Maybe. But I'm not attacking you, I'm making a facetious suggestion which is illuminating another point in my argument. Drug companies would absolutely love your proposals because you are basically suggesting we do away with regulating them, and I can only imagine this would likely be a massive benefit to them and their profit margins. As a reader of Sensible Medicine surely you are aware of how terribly these companies act given the slightest opportunity. If they can make money selling highly addictive opiods that people don't need, they will do it.
Market forces have turned our drug makers into first and foremost, profit makers. Their second priority is to make consumers healthier. If they can get the first without the second, that is absolutely fine with them. Currently the only people who stand between the rapacious drug companies and their consumers are government regulators and doctors. Could private companies and market incentives fill this role? I remain unconvinced.
You mention car safety as an example of a product which is potentially dangerous that benefits from private regulation, but was it not state and federal governments which first had to mandate seatbelts in cars? Ralph Nader in 1965 wrote the book Unsafe at Any Speed highlighting multiple safety problems with cars. These products were killing people and the market was unable to correct iteself before we had to create the US Dept of Transportation and National Highway Safety Administration to start issuing regulations regarding vehicle safety. The main reason you have safe automobile options to choose from is because the government forced those companies to make their products safer. (1)
I also don't find much confidence in your example of liability insurance. Basically your argument there seems to be that legal liability from causing harm ought to be enough to deter drug companies from bad behavior. This again I just do not see. As far as I can tell the profits generally outweigh any legal costs these companies might bear for harming their customers. Maybe in the aftermath of the opiod crisis legal payouts became an actual deterant, but even there I am not sure. Is this sufficient to keep companies from future bad behaviour? I have a hard time seeing it. (2)
Fundamentally I think the problem is just one of a balance of power. Very large companies like automobile and drug manufacturers arn't just some idealized market operator who respond rationally to market incentives. They are power brokers who can buy influence in public and private institutions, they can silence and harrass scientists or activists who highlight problems with their products, they can deploy massive advertising campaigns to shape public opinion. Only an institution of similar size or power would have any hope of reigning in their worst excesses.
I appear to have misread your comment and inferred snark where there was none. I’m sorry. The voice in my head doesn’t always reproduce the sound of others’ voices accurately.
Now to the merits.
You write: Drug companies would absolutely love your proposals because you are basically suggesting we do away with regulating them, and I can only imagine this would likely be a massive benefit to them and their profit margins.
Not so. In the world I envision, people pay directly, i.e., out of pocket with their own money, for most of the health care they need. Direct payment would exert great pressure on drug makers to lower their prices. Don’t believe me? Walk into any retail outlet and check out the prices for OTC drugs. They’re all cheap. Drug makers want the big dollars that insurers pay and would lobby like hell against any reform that would make those dollars harder to obtain. A big problem, and a direct consequences of FDA regulation, is that far too many drugs require prescriptions, are therefore covered by insurance, and are therefore absurdly expensive.
Also, I previously published a column in Sensible Medicine discussing the FDA’s failure to hold drug makers to post-marketing study requirements and showing that insurers could replace the FDA while having incentives to do better. https://www.sensible-med.com/p/using-contracts-to-encourage-post. Opposing governmental regulation is not the same as opposing all regulation. I strongly support private regulation.
Lastly, in my book, Overcharged: Why Americans Pay Too Much For Health Care, I discuss drug makers’ pricing games at length. The first two chapters are devoted to the subject. I am well aware of their avarice. I agree that, as you say, “drug makers” are “first and foremost, profit makers.” That description fits the vast majority of businesses, including many hospitals and others that are nominally non-profit. (For the record, I’d get rid of the non-profit category and the tax preferences that go with it.) Obviously, the “government regulators and doctors” whom you contend are protecting consumers from drug companies are doing a terrible job. The market could hardly do worse.
Re automobile safety: I haven’t studied that area well enough to have an opinion on whether market forces or regulators played the critical role in the adoption of seatbelts. But the answer doesn’t matter. There are probably a zillion innovations that have improved product and service quality for consumers. Given how often regulators intervene, it would be astonishing if there were no examples in which regulators beat markets to the punch. But the fact that markets do better than regulators in the main cannot seriously be contested. Maybe check out the discussion of Peter Schuck’s book, Why Governments Fail So Often, https://www.cato.org/policy-report/may/june-2014/why-government-fails-so-often. Markets also fail, of course. New products and services may not appeal to consumers and have to be modified or dumped. But when that happens, the people who lose are the investors who put their own dollars at risk. When governments fail, the public loses and millions or billions of taxpayer dollars are wasted in the process.
Although I agree with much that is in the article by Prasad and Makary, I believe that people who want a COVID shot and are willing to pay for one with their own money should have access, regardless of the FDA's assessment of efficacy or safety. As Vinay has explained many times, the decision to have the shot is self-regarding. The shot ameliorates the severity of the symptoms. I think it is illegitimate, and beyond the government's normatively defensible role, for the the FDA to prevent people from accessing medicines whose effects are mainly self-regarding. Government exists to prevent people from harming others, not to tell us what we can and cannot do to/for ourselves. If people want the shots and are willing to bear the cost and consequences, the public has no normatively defesible role to play.
Don't worry, if you go pester enough doctors I am sure you can find one who will administer you as many Covid booster as your heart desires. The FDA isn't your doctor, but they are the people who should be evaluating the costs vs. benefits in different populations and I am glad to see them finally doing their jobs.
I don't want COVID boosters. There's no evidence that they help people like me, so why would I? I'm simply tired of public officials and ignorant voters whose values differ enormously from mine sticking their noses into my (and others') private affairs. And we do not need the FDA to assess the costs or benefits of medications or other medical treatments. Private regulators would do the job better and more quickly, and would be less susceptible to pressure from interest groups and interest conflicts. I'd take a pharma version of Consumer Reports over the FDA any day.
Forgot to mention that I also oppose the requirement of obtaining a doctor's permission to get a vaccine (or any other treatment for which an RX is required). In my opinion, doctors should be advisors and treatment providers. They should not be gatekeepers, except when patients want them to be. The combination of the FDA, which decides when RXs are required, and doctors, who charge fees for giving patients permission to access treatments, is a gross and unwarranted denial of the liberty to self-medicate. And, of course, I oppose the war on drugs.
I have the impression Charle’s ideas are widely practiced in many developing nations. If my impression is relatively accurate, is there reliable evidence that such a system tends to be helpful or harmful to the general populace?
A practical, common example is the individual that repeatedly gets antibiotic responsive UTIs multiple times a year with the same predictable symptoms & outcomes. Yet in the US that person needs a UA & MD to get 3-5 day course of cheap antibiotic.
I agree with every statement. In many years of medical practice, I never required a patient to come into the office to get a prescription and never charged for calling one in to the pharmacy. I would give them my advice and if they wanted to discuss it, they could make an appointment and we could talk about it. The only exception were drugs on the narcotic restricted list because that might cause revocation of my license. If it were up to me, any adult could buy any drug they like. For those who have a fear of freedom, I would ask "How has that war on drugs been working out for you over the last 50-60 years? By the way, in 40 years of practice I was never sued and never had any contact with government regulators.
I think you grossly overestimate the general population's ability to determine what is good for them. Your fantasy of personal liberty and freedom would greatly exacerbate the problem of drug companies marketing products to patients that they don't necessarily need. Just imagine if a person could order a medication after watching a commecial for it! Ha! The hospitals would be overwhelmed with overdoses and adverse drug interactions, a true medical wild-west nightmare.
I also don't see why a private regulator would be any less susceptible to corruption than a government one.
Consumers' inability to make intelligent choices is a problem in many areas of economic activity. It is also one that providers have incentives to address when they operate in competitive markets. They do this in many ways, such as by offering money-back guarantees, technical support, and obtaining certifications from independent testing agencies. Ever heard of automobile safety scores? I don't know which cars are safest, but I can easily find out because the Insurance Institute for Highway Safety publishes them. I don't know which cars are the most reliable, but I can find that out too by consulting Consumer Reports. I know little about the technical standards that products should comply with, but sellers make it easy for me to know that their products are properly designed by having them certified by Underwriters Labs (now UL Solutions). UL also certifies that manufacturing plants are up to snuff. These are all private regulators who help consumers make good choices. If we free consumers to buy what they want, these entities and others will do the same for drug purchases.
And, of course, consumers will be free to ask doctors for advice.
I suspect that you know little about private regulators. Have you ever studied, e.g., the role that liability insurers play in improving the quality of medical treatments? I have an article on the subject, coauthored with Prof. Tom Baker, one of the country's leading insurance scholars, in a symposium issue of the DePaul Law Review. https://via.library.depaul.edu/law-review/vol68/iss2/3/.
I also suspect that you've not studied the myriad ways in which markets facilitate intelligent shopping by consumers. I mentioned a couple above, but there are many more. E.g., markets force sellers to disclose prices--as LASIK and other retail health care providers do--and price information is critical for intelligent shopping. They also pressure sellers to track and provide quality information--as IVF providers do, they also being retail providers. Consumer ignorance is an enormous problem in the non-retail health care sector--where most doctors, hospitals, drug companies, and other provider operate--because the system is designed to prevent market forces from working, with the result that providers can make enormous sums while keeping patients in the dark.
In fact I think Sensible Medicine is the wrong audience for your ideas, you should start an organization called Patients for Medical and Health Freedom and start writing op-eds and lobbying Congress about making it easier for drug companies to sell their products directly to consumers without any regulatory oversight. I am sure you would have no shortage of drug companies willing to foot the bill for your new organization. Might even be quite lucrative.
I expect this sort of snarky comment from political partisans and ideologues. Can't deal with the argument on the merits, so attack the author by imputing financial motivations. Sad.
A bit snarky? Maybe. But I'm not attacking you, I'm making a facetious suggestion which is illuminating another point in my argument. Drug companies would absolutely love your proposals because you are basically suggesting we do away with regulating them, and I can only imagine this would likely be a massive benefit to them and their profit margins. As a reader of Sensible Medicine surely you are aware of how terribly these companies act given the slightest opportunity. If they can make money selling highly addictive opiods that people don't need, they will do it.
Market forces have turned our drug makers into first and foremost, profit makers. Their second priority is to make consumers healthier. If they can get the first without the second, that is absolutely fine with them. Currently the only people who stand between the rapacious drug companies and their consumers are government regulators and doctors. Could private companies and market incentives fill this role? I remain unconvinced.
You mention car safety as an example of a product which is potentially dangerous that benefits from private regulation, but was it not state and federal governments which first had to mandate seatbelts in cars? Ralph Nader in 1965 wrote the book Unsafe at Any Speed highlighting multiple safety problems with cars. These products were killing people and the market was unable to correct iteself before we had to create the US Dept of Transportation and National Highway Safety Administration to start issuing regulations regarding vehicle safety. The main reason you have safe automobile options to choose from is because the government forced those companies to make their products safer. (1)
I also don't find much confidence in your example of liability insurance. Basically your argument there seems to be that legal liability from causing harm ought to be enough to deter drug companies from bad behavior. This again I just do not see. As far as I can tell the profits generally outweigh any legal costs these companies might bear for harming their customers. Maybe in the aftermath of the opiod crisis legal payouts became an actual deterant, but even there I am not sure. Is this sufficient to keep companies from future bad behaviour? I have a hard time seeing it. (2)
Fundamentally I think the problem is just one of a balance of power. Very large companies like automobile and drug manufacturers arn't just some idealized market operator who respond rationally to market incentives. They are power brokers who can buy influence in public and private institutions, they can silence and harrass scientists or activists who highlight problems with their products, they can deploy massive advertising campaigns to shape public opinion. Only an institution of similar size or power would have any hope of reigning in their worst excesses.
(1) https://en.wikipedia.org/wiki/Unsafe_at_Any_Speed:_The_Designed-In_Dangers_of_the_American_Automobile#Government_response
(2)https://en.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements
I appear to have misread your comment and inferred snark where there was none. I’m sorry. The voice in my head doesn’t always reproduce the sound of others’ voices accurately.
Now to the merits.
You write: Drug companies would absolutely love your proposals because you are basically suggesting we do away with regulating them, and I can only imagine this would likely be a massive benefit to them and their profit margins.
Not so. In the world I envision, people pay directly, i.e., out of pocket with their own money, for most of the health care they need. Direct payment would exert great pressure on drug makers to lower their prices. Don’t believe me? Walk into any retail outlet and check out the prices for OTC drugs. They’re all cheap. Drug makers want the big dollars that insurers pay and would lobby like hell against any reform that would make those dollars harder to obtain. A big problem, and a direct consequences of FDA regulation, is that far too many drugs require prescriptions, are therefore covered by insurance, and are therefore absurdly expensive.
Also, I previously published a column in Sensible Medicine discussing the FDA’s failure to hold drug makers to post-marketing study requirements and showing that insurers could replace the FDA while having incentives to do better. https://www.sensible-med.com/p/using-contracts-to-encourage-post. Opposing governmental regulation is not the same as opposing all regulation. I strongly support private regulation.
Lastly, in my book, Overcharged: Why Americans Pay Too Much For Health Care, I discuss drug makers’ pricing games at length. The first two chapters are devoted to the subject. I am well aware of their avarice. I agree that, as you say, “drug makers” are “first and foremost, profit makers.” That description fits the vast majority of businesses, including many hospitals and others that are nominally non-profit. (For the record, I’d get rid of the non-profit category and the tax preferences that go with it.) Obviously, the “government regulators and doctors” whom you contend are protecting consumers from drug companies are doing a terrible job. The market could hardly do worse.
Re automobile safety: I haven’t studied that area well enough to have an opinion on whether market forces or regulators played the critical role in the adoption of seatbelts. But the answer doesn’t matter. There are probably a zillion innovations that have improved product and service quality for consumers. Given how often regulators intervene, it would be astonishing if there were no examples in which regulators beat markets to the punch. But the fact that markets do better than regulators in the main cannot seriously be contested. Maybe check out the discussion of Peter Schuck’s book, Why Governments Fail So Often, https://www.cato.org/policy-report/may/june-2014/why-government-fails-so-often. Markets also fail, of course. New products and services may not appeal to consumers and have to be modified or dumped. But when that happens, the people who lose are the investors who put their own dollars at risk. When governments fail, the public loses and millions or billions of taxpayer dollars are wasted in the process.