Totally agree that one’s reaction to the Prasad/Makary NEJM piece will depend entirely on one’s priors.
I am almost in lockstep with their position. However, in an effort to diversify my feed (and avoid self-silofication), I do try to read some people with whom I generally disagree. This includes some Covid-maximizers who in 2025 I consider deeply misguided. But one objection that has been raised is that the FDA could have “allowed” access without “promoting”, or “recommending”, uptake among low risk groups. This way, those (with low risk) who want it can nonetheless exercise that choice, while the “requirements” are in line with fellow western/first world nations. I feel this would have been an acceptable compromise, and doesn’t preclude the conduct of proper studies on clinical outcomes that I agree are sorely lacking.
Evidence is only as good as the quality of the data. The data on covid are completely useless due to the unreliability of the tests---primarily PCR and antibodies. So I would argue with the statement that there was robust evidence of benefit. Regardless of that, no government agency or anyone else should have the right to cancel out the wishes of those who want the shot and those who don't.
While a change in the ways Covid vaccines are evaluated is overdue, I'm not sure that this new framework helps, other than to discourage companies from developing more vaccines - in fact that may be the goal here. As an immunologist with deep experience in clinical research, I agree that clinical and immunological endpoints are helpful, but they will not provide significantly greater understanding of what is important for protective (not necessarily sterilizing) immunity. Because the recommendations are based solely on antibody responses and not T cell responses which appear to be much longer lasting and much broader than antibody responses, new studies should include sufficiently large sub-studies of SARS-CoV2 T cell immunity at baseline and several weeks after vaccination. That might help answer the question of whether boosters are even helpful at all.
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.
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.
Approximately 50 million Americans have an autoimmune disease or 15%, 44% of Americans are obese. 70% overweight. 11.6% of Americans have diabetes and another 38% have pre-diabetes. 48% of Americans have some form of cardiovascular disease. In more simple terms, most Americans are "fat, sick and nearly dead". Only 8% - 10% of us are even metabolically healthy. Ironically, I guess this means about 90% can still get their shot as all those conditions drive up the risk (and always have) of complications of severe illness and death. As long as so called 'health care' is continued to be practiced as a disease management business, I'm afraid things won't change much. We need a whole new paradigm in medicine because the practice of medicine as 'disease management' is not sustainable.
As I said on Mandrola’s page - thank goodness for some common sense (which isn’t very common these days!) in the chaff of government paid shill bullshit. I hope (and believe) that the voices of reason cannot be bought.
Medicine needs to balance care the people need with care that people want. If the patient doesn’t want it, even if the experts know they need it, the patient won’t accept it. Nor should they as this would violate their autonomy.
If there is a huge demand for care that people want, then medicine should at least make an effort to meet that demand. Think working people who cannot see their PCP Monday to Friday. There should be innovation to meet the desires of people who cannot readily see a PCP outside of “normal” working hours.
This is not, however, to say that medicine should provide something harmful just because a patient wants it. All day long, I tell people that I cannot do what they want me to do. Think of the morbidly obese, smoking, diabetic who recently was released from the hospital. I simply will not sedate this person in my office no matter how much they want me to. I will offer them other options to meet both their needs and their wishes.
There needs to be a balance between care that people need and care that they want.
A small step in the right direction. I wonder if this is as far as they truly believe we should go, or just as far as they are willing to push at the moment. I suspect the latter.
Totally agree that one’s reaction to the Prasad/Makary NEJM piece will depend entirely on one’s priors.
I am almost in lockstep with their position. However, in an effort to diversify my feed (and avoid self-silofication), I do try to read some people with whom I generally disagree. This includes some Covid-maximizers who in 2025 I consider deeply misguided. But one objection that has been raised is that the FDA could have “allowed” access without “promoting”, or “recommending”, uptake among low risk groups. This way, those (with low risk) who want it can nonetheless exercise that choice, while the “requirements” are in line with fellow western/first world nations. I feel this would have been an acceptable compromise, and doesn’t preclude the conduct of proper studies on clinical outcomes that I agree are sorely lacking.
Evidence is only as good as the quality of the data. The data on covid are completely useless due to the unreliability of the tests---primarily PCR and antibodies. So I would argue with the statement that there was robust evidence of benefit. Regardless of that, no government agency or anyone else should have the right to cancel out the wishes of those who want the shot and those who don't.
While a change in the ways Covid vaccines are evaluated is overdue, I'm not sure that this new framework helps, other than to discourage companies from developing more vaccines - in fact that may be the goal here. As an immunologist with deep experience in clinical research, I agree that clinical and immunological endpoints are helpful, but they will not provide significantly greater understanding of what is important for protective (not necessarily sterilizing) immunity. Because the recommendations are based solely on antibody responses and not T cell responses which appear to be much longer lasting and much broader than antibody responses, new studies should include sufficiently large sub-studies of SARS-CoV2 T cell immunity at baseline and several weeks after vaccination. That might help answer the question of whether boosters are even helpful at all.
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.
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.
Approximately 50 million Americans have an autoimmune disease or 15%, 44% of Americans are obese. 70% overweight. 11.6% of Americans have diabetes and another 38% have pre-diabetes. 48% of Americans have some form of cardiovascular disease. In more simple terms, most Americans are "fat, sick and nearly dead". Only 8% - 10% of us are even metabolically healthy. Ironically, I guess this means about 90% can still get their shot as all those conditions drive up the risk (and always have) of complications of severe illness and death. As long as so called 'health care' is continued to be practiced as a disease management business, I'm afraid things won't change much. We need a whole new paradigm in medicine because the practice of medicine as 'disease management' is not sustainable.
As I said on Mandrola’s page - thank goodness for some common sense (which isn’t very common these days!) in the chaff of government paid shill bullshit. I hope (and believe) that the voices of reason cannot be bought.
As always - thoughtful and measured and again Adam I am in total agreement -
Medicine needs to balance care the people need with care that people want. If the patient doesn’t want it, even if the experts know they need it, the patient won’t accept it. Nor should they as this would violate their autonomy.
If there is a huge demand for care that people want, then medicine should at least make an effort to meet that demand. Think working people who cannot see their PCP Monday to Friday. There should be innovation to meet the desires of people who cannot readily see a PCP outside of “normal” working hours.
This is not, however, to say that medicine should provide something harmful just because a patient wants it. All day long, I tell people that I cannot do what they want me to do. Think of the morbidly obese, smoking, diabetic who recently was released from the hospital. I simply will not sedate this person in my office no matter how much they want me to. I will offer them other options to meet both their needs and their wishes.
There needs to be a balance between care that people need and care that they want.
The media spin, especially headlines, is predictable and damaging.
A small step in the right direction. I wonder if this is as far as they truly believe we should go, or just as far as they are willing to push at the moment. I suspect the latter.
Heneghan and Jefferson this morning write
"The whole announcement may be the most significant step forward in EBM in the last decade."
They call it a compromise, which is rational.
https://trusttheevidence.substack.com/p/the-fda-is-moving-towards-an-evidence