What prevents pharma and insurers (which have already pharma as their clients) to find "mutually profitable balances of interests" instead of representing conflicting parties?
I might not know enough of the mechanisms behind health insurances but what is the incentive for insurers to not pay for worse drugs? They would still pay for better drugs. This sounds just like something that increases the market for the insurance industry without any sound guarantee (maybe except the most blatant cases that hopefully already the agencies would capture?) to the consumer.
It's a good idea, but it needs careful development. What's to prevent Big Insurance from becoming like Big Pharma....in bed with the FDA, CDC, etc.? The FDA/CDC cannot be trusted anymore to be watchdog agencies for the American public. There is too much corruption at the top. Term limits would help: for any upper level management of these agencies AND Congress. There needs to be a 5-10 year waiting period before a Big Pharma employee can work in government and vice/versa. There needs to be an consumer watchdog organization (lay persons), funded by the private companies, to keep an eye on the relationships between the companies and government. Finally, companies should not be allowed to fund government officials or their campaigns, not even through CAPs.
Isn’t that the premise of CMS’s Coverage with Evidence Development (CED) program: CMS covers your drug, but you Pharma keep a registry of patients and prove safety and efficacy? And even then, what CMS and other US payers want is cost-efficiency, that, as the European experience has shown us, is yet another can of worms.
Pharma companies suppress (don't publish) most studies with negative results. They limit most clinical trials to 3-6 months because it's cheaper and the negative (side) effects of longer term use usually don't show up yet. It is naive to think that the FDA, which was captured by Pharma interests back in the Reagan administration, would ever be allowed to push for more post-approval studies. There is a very weak "reporting" structure for one-off negative patient effects, but it's more of a fig leaf than real monitoring system.
In my job as a Medical Director for a mid-sized PPO-TPA (2010 to 2022), I spent a lot of time explaining to providers and patients that 'FDA approval' was a necessary but insufficient standard for approving health plan coverage. My training as a pharmacologist (PhD 1988) helped as I worked to explain the issues. Ultimately though, the conversation boiled down to a simple concept: payers want to spend money on things that work. And 'things that work' need to be demonstrated to be safe, effective, and a better value that existing alternatives. In this context, an initial FDA approval - especially an 'accelerated' approval does not serve.
My experiences with explaining the 'simple concept' convinced me that most physicians (along with - so called - physician extenders) have a limited (inadequate) understanding of clinical science, pharmacology, and the workings of the FDA, health care insurance, and government.
I think the concept of payer-seller contracts as described in this essay should be pursued...!
The FDA has totally abdicated its responsibility and has become a progressively more useless organ in my 20+ years of practice thus far.
Very broadly speaking, whereas society wants therapies that are “useful and safe”, it appears the FDA as gatekeeper is now satisfied with little more than “safe but useless” (and sometimes, not even that).
It’s a great idea for “end users” (patients and payers) to hold manufacturers to account, with conditional reimbursement carrots and sticks predicated on purveyors actually sustaining their claims beyond the low bar needed for initial approval these days.
Something that works along the lines of general insurance principles could be useful. But the major "insurer" is the government and they certainly don't operate along those lines. We already have a virtual "single payer" system for the great majority of medical care and many people and organizations are pushing to complete the job. The best scenario (which we will never see) would be a free market in drugs and medical care. First step would be abolition of the FDA and all other government agencies dealing with medical care. In a free market insurance companies can offer various levels of medical insurance to suit the needs of various people. The pharmaceutical companies could make whatever contractual arrangements they wish with insurers.
As someone tasked with approving cancer research trials at their academic medical center these contracts would make my work a lot less cringeworthy.
All too often it is clear that industry has written their trial with FDA approved surrogate metrics for maximum (temporal) profit with no provision for long-term survival follow-up.
This is all very confusing for a professional with 20 years of experience. Lay patients have a greater chance of being befuddled.
This might work. It would be interesting to see uf the government would have the balls to do this with vaccines instead of pretending all is fine and dandy whilst paying out damages and denying it.
"accepts their voluntary commitments" to make more money that's a laugh....why would anyone think a company online to make millions would do anything to stop it coming in?
“appear to be safe and effective” another good one
“ The FDA approved Aduhelm on an accelerated basis despite a shortage of evidence” ... is that the safe and effective part??
Maybe we could just stop the revolving door between Big Pharma and the FDA??
We won’t talk about IF there MAY be any lifestyle issues that contribute to Alzheimer’s (and yes MIL had it so I know).
Post-marketing monitoring is an excellent concept. However, I'm skeptical that insurance companies—whose goals often prioritize limiting usage and maximizing profit—are equipped to design rational studies. It feels like an attempt to bypass a dysfunctional FDA. Better to fix the problem than create a work around.
Agree with this approach wholeheartedly. Change needed. Unfortunately our political/health care system as it is has no accountability and not enough transparency.
And what is the incentive for our largest source of reimbursement (Medicare/Medicaid) to hold the drug/device manufacturers accountable)? Altruism? Stewardship of tax dollars? Pretty telling how both democrats and republicans
"... insurers...feel significant pressure from patients and politicians to cover all drugs and devices that patients may want." Why would a patient want a possibly ineffective and/or unsafe drug? ADVERTISING! It's time for the US to follow the smart countries that have banned drug advertising. With the exception of Sensible Medicine readers, most people don't read the research nor do they understand experimental design and statistical analysis well enough to accurately judge this information for themselves. Perhaps if the FDA would finally approve "The Drug Facts Box," that would help. If a drug is only conditionally approved by the FDA, this should be in a Black Box warning on the box. It's this lack of oversight that has led to Trump saying he will make a non-scientist who has repeatedly lied about vaccines, RFK, his FDA chief.
What prevents pharma and insurers (which have already pharma as their clients) to find "mutually profitable balances of interests" instead of representing conflicting parties?
I might not know enough of the mechanisms behind health insurances but what is the incentive for insurers to not pay for worse drugs? They would still pay for better drugs. This sounds just like something that increases the market for the insurance industry without any sound guarantee (maybe except the most blatant cases that hopefully already the agencies would capture?) to the consumer.
Something like this would have been excellent to have for the failed COVID vaccines.
It's a good idea, but it needs careful development. What's to prevent Big Insurance from becoming like Big Pharma....in bed with the FDA, CDC, etc.? The FDA/CDC cannot be trusted anymore to be watchdog agencies for the American public. There is too much corruption at the top. Term limits would help: for any upper level management of these agencies AND Congress. There needs to be a 5-10 year waiting period before a Big Pharma employee can work in government and vice/versa. There needs to be an consumer watchdog organization (lay persons), funded by the private companies, to keep an eye on the relationships between the companies and government. Finally, companies should not be allowed to fund government officials or their campaigns, not even through CAPs.
Isn’t that the premise of CMS’s Coverage with Evidence Development (CED) program: CMS covers your drug, but you Pharma keep a registry of patients and prove safety and efficacy? And even then, what CMS and other US payers want is cost-efficiency, that, as the European experience has shown us, is yet another can of worms.
Pharma companies suppress (don't publish) most studies with negative results. They limit most clinical trials to 3-6 months because it's cheaper and the negative (side) effects of longer term use usually don't show up yet. It is naive to think that the FDA, which was captured by Pharma interests back in the Reagan administration, would ever be allowed to push for more post-approval studies. There is a very weak "reporting" structure for one-off negative patient effects, but it's more of a fig leaf than real monitoring system.
In my job as a Medical Director for a mid-sized PPO-TPA (2010 to 2022), I spent a lot of time explaining to providers and patients that 'FDA approval' was a necessary but insufficient standard for approving health plan coverage. My training as a pharmacologist (PhD 1988) helped as I worked to explain the issues. Ultimately though, the conversation boiled down to a simple concept: payers want to spend money on things that work. And 'things that work' need to be demonstrated to be safe, effective, and a better value that existing alternatives. In this context, an initial FDA approval - especially an 'accelerated' approval does not serve.
My experiences with explaining the 'simple concept' convinced me that most physicians (along with - so called - physician extenders) have a limited (inadequate) understanding of clinical science, pharmacology, and the workings of the FDA, health care insurance, and government.
I think the concept of payer-seller contracts as described in this essay should be pursued...!
Fantastic post.
The FDA has totally abdicated its responsibility and has become a progressively more useless organ in my 20+ years of practice thus far.
Very broadly speaking, whereas society wants therapies that are “useful and safe”, it appears the FDA as gatekeeper is now satisfied with little more than “safe but useless” (and sometimes, not even that).
It’s a great idea for “end users” (patients and payers) to hold manufacturers to account, with conditional reimbursement carrots and sticks predicated on purveyors actually sustaining their claims beyond the low bar needed for initial approval these days.
Something that works along the lines of general insurance principles could be useful. But the major "insurer" is the government and they certainly don't operate along those lines. We already have a virtual "single payer" system for the great majority of medical care and many people and organizations are pushing to complete the job. The best scenario (which we will never see) would be a free market in drugs and medical care. First step would be abolition of the FDA and all other government agencies dealing with medical care. In a free market insurance companies can offer various levels of medical insurance to suit the needs of various people. The pharmaceutical companies could make whatever contractual arrangements they wish with insurers.
As someone tasked with approving cancer research trials at their academic medical center these contracts would make my work a lot less cringeworthy.
All too often it is clear that industry has written their trial with FDA approved surrogate metrics for maximum (temporal) profit with no provision for long-term survival follow-up.
This is all very confusing for a professional with 20 years of experience. Lay patients have a greater chance of being befuddled.
This might work. It would be interesting to see uf the government would have the balls to do this with vaccines instead of pretending all is fine and dandy whilst paying out damages and denying it.
"accepts their voluntary commitments" to make more money that's a laugh....why would anyone think a company online to make millions would do anything to stop it coming in?
“appear to be safe and effective” another good one
“ The FDA approved Aduhelm on an accelerated basis despite a shortage of evidence” ... is that the safe and effective part??
Maybe we could just stop the revolving door between Big Pharma and the FDA??
We won’t talk about IF there MAY be any lifestyle issues that contribute to Alzheimer’s (and yes MIL had it so I know).
Here's an improved version of your statement:
Post-marketing monitoring is an excellent concept. However, I'm skeptical that insurance companies—whose goals often prioritize limiting usage and maximizing profit—are equipped to design rational studies. It feels like an attempt to bypass a dysfunctional FDA. Better to fix the problem than create a work around.
Agree with this approach wholeheartedly. Change needed. Unfortunately our political/health care system as it is has no accountability and not enough transparency.
And what is the incentive for our largest source of reimbursement (Medicare/Medicaid) to hold the drug/device manufacturers accountable)? Altruism? Stewardship of tax dollars? Pretty telling how both democrats and republicans
Smoke and mirrors…
Thank you. Great idea!
Or we could just give it to a billion people and hope for the best.
Not that we've done that before LOL
"... insurers...feel significant pressure from patients and politicians to cover all drugs and devices that patients may want." Why would a patient want a possibly ineffective and/or unsafe drug? ADVERTISING! It's time for the US to follow the smart countries that have banned drug advertising. With the exception of Sensible Medicine readers, most people don't read the research nor do they understand experimental design and statistical analysis well enough to accurately judge this information for themselves. Perhaps if the FDA would finally approve "The Drug Facts Box," that would help. If a drug is only conditionally approved by the FDA, this should be in a Black Box warning on the box. It's this lack of oversight that has led to Trump saying he will make a non-scientist who has repeatedly lied about vaccines, RFK, his FDA chief.
https://lisaschwartzfoundation.org/drug-fact-boxes#:~:text=To help people make informed,approved use of a drug.