7 ms·

I work in medical research and mostly agree with this, but there are two major problems I see preventing this from becoming a reality: 1) Academic medical rese

by cgiles 7y ago

I work in medical research and mostly agree with this, but there are two major problems I see preventing this from becoming a reality: 1) Academic medical research is simply not well tooled, right now, to do the later stages of drug development. What pharma does well and academia does not, is basically optimization of candidates. They do it through high-throughput screens and medicinal chemistry. Those things are very expensive and not publishable, so...academics don't do them. And everyone with the expertise works in pharma. 2) Clinical trials are freaking expensive. My institute has developed several drug candidates and the same process necessarily applies every time. The public-funded researcher basically HAS to either sell the patent to pharma or start a company and raise the many millions required to do a trial. The amount of money required is way out of range of current grant funding. If they want to see their drug get to patients, and of course they do, there is literally no other way right now except partnering with pharma. When I get a chance to talk to politicians about how to fix this, I always make the same pitch. Step #1 should be to give a huge wad of money to the FDA. Say $1B/yr. Then you tell the FDA: every year, pick the 50 most promising drug candidates. Publicly fund the clinical trials, and the public will own the patent. Give some cash to the inventor and the institute to incentivize them to do this scheme and not sell to pharma. Politicians, both left and right, look at me like I'm from Mars when I propose this. Those on the left think high drug costs are all about greed and not our broken system, and those on the right have unwavering faith that "free" markets will always solve everything. And with insulin specifically, there is another problem: diabetics won't take the generic insulin that has been off-patent for years now. They must have the fancy and more convenient version. Mark my words, the fact that Americans must always have the absolute best thing, cost be damned, will become a major issue if we ever get single-payer.

keldaris 7y ago
> Politicians, both left and right, look at me like I'm from Mars when I propose this. Those on the left think high drug costs are all about greed and not our broken system, and those on the right have unwavering faith that "free" markets will always solve everything. Do you think they actually believe any of this nonsense? I would have assumed the rehearsed political phrasing is just the public veneer over something to the effect of "and if I endorse this, X lobby group(s) will steer Y amount of PAC funding to my primary opponent and eat me alive".
- cgiles 7y ago
  There is a fair amount of that. But I think the bigger problem is dogmatic ideology. Many of those on the right are just ideologically opposed to government spending on anything (that isn't the military). It is often a win to get them to provisionally admit that, maybe, possibly, ANY government spending on research is useful. So "give more money to the FDA" is where they stop listening. On the left, there is often a dogmatic refusal to even try to understand how markets and incentives work. They tend to inhabit a fantasy world where all humans are, or should be, pure altruists. If you think it is just pharma that responds to monetary incentives, you'd be dead wrong. Publicly-funded institutions LOVE this system as well because the typical endpoint is that when one of their researchers develops a candidate, the patent is sold to pharma...BUT the institute retains a right to, say, 5% of profits. Why not just allow drug imports from Canada and India? It is because we -- meaning the American consumer and taxpayer -- are subsidizing drug development for the entire world. The current system in the USA, bad as it is for American consumers, develops the majority of new drugs for the whole world. I have no doubt that if you allow foreign drug imports without other reform in the system, you actually will see less drug development.
  - AcerbicZero 7y ago
    I have no issue with this, although having to open up competition to companies regulated by external regulatory bodies does kind of highlight how regulatory capture has destroyed the ability of the free market to solve this issue internally. True competition is almost always a good thing.
sterlind 7y ago
aren't there some diabetics that need the newer types of insulin? is it really true that all diabetics could take the generic, classical insulin without any problems, and suffer no health consequences? I mean I doubt they pay hundreds of dollars just to sport the Mylan brand like like a Gucci purse..
- cgiles 7y ago
  To my knowledge -- keeping in mind this is not my area -- there are modest benefits for newer types of insulin. You have to dose less often. The variance in swings of blood glucose is lower -- newer types tend to be more "extended release". Some types can be inhaled instead of being injected, which is obviously preferable. But in my understanding, in general, there are no major health risks from using plain insulin, and it is mostly about convenience. I do not know if that is true for all diabetics. EDIT: kkreamer above says there are differences in long-term complication risks between insulin types. From my very brief literature review just now, that looks to be true. I guess I have become jaded because of the number of diabetics I have recently heard complaining that they are in danger of IMMINENT DEATH because they cannot afford their insulin. Long-term complication risks are important but it is not the same thing. This is how pharma keeps the whole scheme going. They invent a drug that is marginally better in some way, refreshing the patent. Then, if the consumer cannot afford the product that is even 5% better, the consumer feels as if they might as well have been sent to a death panel.
  - kkreamer 7y ago
    This depends on what you mean by "plain insulin". If you are referring to NPH and R, there's a massive world of difference going to, say, Novolog and Lantus. If you're comparing something like Lantus versus Tresiba, sure, it's more "extended release" Or yes, Afrezza is inhalable. But when people complain about the cost of insulin, they're referring to the cost, and especially the huge cost increases, of insulins like Lantus and Novolog (that have been out for a couple decades now), not the cost of new insulins like Afrezza or Tresiba.
  - kkreamer 7y ago
    To clarify, the IMMINENT DEATH possibility is also true, in the case of diabetic ketoacidosis, which is caused from lack of insulin. Yes, if it came to it, you could use Walmart's NPH/R to avoid DKA, but then you put yourself at a higher risk of severe hypoglycemia (extreme low blood sugar) due to the way those insulins work, which can also result in imminent death. My comment previously was referring to the best case, where you only lose some toes or a foot in a decade or two.
frandroid 7y ago
> Say $1B/yr That's not even a lot of money, in the U.S. context.
koolba 7y ago
> When I get a chance to talk to politicians about how to fix this, I always make the same pitch. Step #1 should be to give a huge wad of money to the FDA. Say $1B/yr. Then you tell the FDA: every year, pick the 50 most promising drug candidates. Publicly fund the clinical trials, and the public will own the patent. Give some cash to the inventor and the institute to incentivize them to do this scheme and not sell to pharma. This would be abused like any other slush fund. Plus there’s a natural adverse selection bias as all the “really good” patents will go the private route. The real answer to all of this is to pass a law that drug prices in the USA have to be less than anywhere else on earth. Let that kick off a race to the bottom amongst the world’s countries. Let them eat the cost of constant marketing in the first world. Some will argue that’s not fair to the millions in less affluent nations. I say who cares? A governments’s foremost job is to protect its own citizens. The current pharma pricing system milks the American consumer so as to subsidize the rest of the planet. It’s long past time to end that.
- cgiles 7y ago
  > This would be abused like any other slush fund. That's a Fully Generic Argument against any pool of government money for any purpose. The law could be written in such a way that the money is allocated for this specific purpose. > Plus there’s a natural adverse selection bias as all the “really good” patents will go the private route. A valid critique. The long-term goal, of course, would be to expand the program and phase out pharma entirely. An intermediate step would be to increasingly offer grants to academics with the stipulation "if you take this grant money, you must go the public route". In much the same way that now, any research published with NIH funds must be open-access within 1 (2? I forget) years. > The current pharma pricing system milks the American consumer so as to subsidize the rest of the planet. Yes, but... > The real answer to all of this is to pass a law that drug prices in the USA have to be less than anywhere else on earth. And you don't think this would negatively impact the rate of drug development? I do. Price controls are also a very drastic step in terms of American law. They tend to have...undesirable side-effects. If I were pondering general solutions in the area of what you are talking about, I'd prefer laws drastically limiting the amount and type of marketing pharma can do. And ideally supplement that with FDA-provided, more objective material for consumers and MDs about the actual, objective benefits and risks of various drugs.
kkreamer 7y ago
Not going to respond on the rest of your comment, but on insulin, I want to rebut the idea that generics are the same as "fancy and more convenient" versions. They are completely different drugs with different (and far worse) clinical outcomes. You might as well say "infected people won't have amputations like we've been doing forever. They must always have the fancy and more convenient antibiotics instead." The fact is, because of intrinsic differences in the types of insulin, a regimen of NPH and/or R can not help but have a significant increase in diabetic complications (including amputations, as in my statement above) than a basal/bolus regimen of Lantus/Levemir and Novolog/Humalog -- all of which have been available for something like 20 years and all of which have seen predatory price increases.
- cgiles 7y ago
  You are right, and I altered a comment below to reflect this. I was trying to make a more general point and phrased it poorly. The general point is: the reason drug costs are high because of two things working together: 1) Pharma continually refreshes patents by making modest, but real, improvements to things that are generically available. 2) Patients will not accept any level of increased health risk, no matter how much the cost increases in exchange for decreased risk. The result of these two things is that even though we have generics available for almost every major disease, they are rarely used, and we are always using the patented versions which are orders of magnitude more expensive. And then we have people wondering why health care is so expensive. It would be absolutely bizarre if it were any other area of the economy. Imagine if every person insisted on owning a sports car because they go 20% faster. But because we (the public in general) continue on insisting that no price can be placed on marginal increases human life or health -- despite the huge logical contradictions that result from this -- we cannot have rational discussions about how to actually keep health care affordable.
  - kkreamer 7y ago
    I totally agree with you regarding drug prices overall, but insulin is different in this respect. A vial of Humalog cost $35 in 2001. The exact same size vial of the exact same insulin -- no refreshed patent, no reformulations, no improvements, no change whatsoever -- cost $270 in 2017. If the price would have only followed inflation, it would have been $48.50 in 2017.
MrFoof 7y ago
>And with insulin specifically, there is another problem: diabetics won't take the generic insulin that has been off-patent for years now. A huge reason I found is your doctor won't ever recommend it. Most diabetics may very well just be blissfully ignorant (I was until recently) that it's even an option, save for Wal-Mart very heavily marketing their "Reli-On" branded insulin produced by Novo Nordisk. I wonder if PCPs (not endocrinologists) are even aware it exists. I've had many PCPs in the past few years, from one of the best health care centers in the US, never recommend it as an option, and seemed to forget it even existed. I guess when you recommend Eli Lilly's biologic-developed analogs for decades and decades, you damn near forget about the old school insulin out of habit. I recently switched, WITHOUT a doctor's approval (none would recommend it). I have to be more careful, but my costs of using purely generic everything plummeted to below 1997-era insured levels Increasingly insurance co-pays have gotten far more expensive for the biologics, and increasingly plans don't even cover the biologic-process analogs anymore (where my costs would be $560/mo for just the insulins that aren't covered by my current plan, or $130/mo if I paid another +$230/mo for a better single-person insurance plan -- only a $170/mo net reduction). My uninsured "no prescription required" OTC costs for all my diabetic supplies (two insulins, sharps container, lancets, test strips) are $69/mo, and $18/mo (prescription required) for generic syringes now. It required taking everything in my own hands and telling every PCP I had to #$%& their hat.
conanbatt 7y ago
> Step #1 should be to give a huge wad of money to the FDA. Say $1B/yr. Then you tell the FDA: every year, pick the 50 most promising drug candidates. Publicly fund the clinical trials, and the public will own the patent. Give some cash to the inventor and the institute to incentivize them to do this scheme and not sell to pharma. I think the FDA is whats making drugs prohibitively expensive. First by disallowing the importation of drugs, second by putting a very conservative standard on the commercialization of drugs. You are right about something, the policy is unappealing for either side. The right doesn't want to give more money to the FDA, and the left doesn't care about giving a gov institution pocket money, they want to outright outlaw profits as a whole. Call yourself Elon because you are on Mars :)
- Aloha 7y ago
  The standard we have for drugs now was paid for in lives. Elixir Sulfonamide, Profusion of Barbiturate use in the 50's, Thalidomide (which the US missed because of our more stringent rules), Phen-Fen - I can go on.
  - conanbatt 7y ago
    The standard you have now is also paid with lives. It's the people that can't get a drug in time or can't pay for it thats killing people.
refurb 7y ago
Say $1B/yr. Then you tell the FDA: every year, pick the 50 most promising drug candidates. Publicly fund the clinical trials, and the public will own the patent. What do you think the FDA knows about running clinical trials? They are obviously experts when it comes to regulatory aspects, but what about trial recruitment, monitoring, supply chain, etc? And what about the educational side? Doctors need someone to talk to, to explain the data, to answer a multitude of questions. It would take FAR more than $1B per year to have the FDA so all that. The Pharma industry spends $70B plus on R&D each year and they already have all the infrastructure. And don’t for one second believe that getting a drug to market is as simple as funding clinical trials. There is a ton of upkeep once approved - phase 4 trials, manufacturing tweaks, educating physicians and customers. 2019 FDA budget was $5.7B. I’d guess you’d need closer to 20x to replicate the work the pharma industry is doing, just on the R&D side, let alone everything else.

by cgiles 7y ago

keldaris 7y ago

> Politicians, both left and right, look at me like I'm from Mars when I propose this. Those on the left think high drug costs are all about greed and not our broken system, and those on the right have unwavering faith that "free" markets will always solve everything. Do you think they actually believe any of this nonsense? I would have assumed the rehearsed political phrasing is just the public veneer over something to the effect of "and if I endorse this, X lobby group(s) will steer Y amount of PAC funding to my primary opponent and eat me alive".

cgiles 7y ago
There is a fair amount of that. But I think the bigger problem is dogmatic ideology. Many of those on the right are just ideologically opposed to government spending on anything (that isn't the military). It is often a win to get them to provisionally admit that, maybe, possibly, ANY government spending on research is useful. So "give more money to the FDA" is where they stop listening. On the left, there is often a dogmatic refusal to even try to understand how markets and incentives work. They tend to inhabit a fantasy world where all humans are, or should be, pure altruists. If you think it is just pharma that responds to monetary incentives, you'd be dead wrong. Publicly-funded institutions LOVE this system as well because the typical endpoint is that when one of their researchers develops a candidate, the patent is sold to pharma...BUT the institute retains a right to, say, 5% of profits. Why not just allow drug imports from Canada and India? It is because we -- meaning the American consumer and taxpayer -- are subsidizing drug development for the entire world. The current system in the USA, bad as it is for American consumers, develops the majority of new drugs for the whole world. I have no doubt that if you allow foreign drug imports without other reform in the system, you actually will see less drug development.
- AcerbicZero 7y ago
  I have no issue with this, although having to open up competition to companies regulated by external regulatory bodies does kind of highlight how regulatory capture has destroyed the ability of the free market to solve this issue internally. True competition is almost always a good thing.

sterlind 7y ago

aren't there some diabetics that need the newer types of insulin? is it really true that all diabetics could take the generic, classical insulin without any problems, and suffer no health consequences? I mean I doubt they pay hundreds of dollars just to sport the Mylan brand like like a Gucci purse..

cgiles 7y ago
To my knowledge -- keeping in mind this is not my area -- there are modest benefits for newer types of insulin. You have to dose less often. The variance in swings of blood glucose is lower -- newer types tend to be more "extended release". Some types can be inhaled instead of being injected, which is obviously preferable. But in my understanding, in general, there are no major health risks from using plain insulin, and it is mostly about convenience. I do not know if that is true for all diabetics. EDIT: kkreamer above says there are differences in long-term complication risks between insulin types. From my very brief literature review just now, that looks to be true. I guess I have become jaded because of the number of diabetics I have recently heard complaining that they are in danger of IMMINENT DEATH because they cannot afford their insulin. Long-term complication risks are important but it is not the same thing. This is how pharma keeps the whole scheme going. They invent a drug that is marginally better in some way, refreshing the patent. Then, if the consumer cannot afford the product that is even 5% better, the consumer feels as if they might as well have been sent to a death panel.
- kkreamer 7y ago
  This depends on what you mean by "plain insulin". If you are referring to NPH and R, there's a massive world of difference going to, say, Novolog and Lantus. If you're comparing something like Lantus versus Tresiba, sure, it's more "extended release" Or yes, Afrezza is inhalable. But when people complain about the cost of insulin, they're referring to the cost, and especially the huge cost increases, of insulins like Lantus and Novolog (that have been out for a couple decades now), not the cost of new insulins like Afrezza or Tresiba.
- kkreamer 7y ago
  To clarify, the IMMINENT DEATH possibility is also true, in the case of diabetic ketoacidosis, which is caused from lack of insulin. Yes, if it came to it, you could use Walmart's NPH/R to avoid DKA, but then you put yourself at a higher risk of severe hypoglycemia (extreme low blood sugar) due to the way those insulins work, which can also result in imminent death. My comment previously was referring to the best case, where you only lose some toes or a foot in a decade or two.

frandroid 7y ago

> Say $1B/yr That's not even a lot of money, in the U.S. context.

koolba 7y ago

> When I get a chance to talk to politicians about how to fix this, I always make the same pitch. Step #1 should be to give a huge wad of money to the FDA. Say $1B/yr. Then you tell the FDA: every year, pick the 50 most promising drug candidates. Publicly fund the clinical trials, and the public will own the patent. Give some cash to the inventor and the institute to incentivize them to do this scheme and not sell to pharma. This would be abused like any other slush fund. Plus there’s a natural adverse selection bias as all the “really good” patents will go the private route. The real answer to all of this is to pass a law that drug prices in the USA have to be less than anywhere else on earth. Let that kick off a race to the bottom amongst the world’s countries. Let them eat the cost of constant marketing in the first world. Some will argue that’s not fair to the millions in less affluent nations. I say who cares? A governments’s foremost job is to protect its own citizens. The current pharma pricing system milks the American consumer so as to subsidize the rest of the planet. It’s long past time to end that.

cgiles 7y ago
> This would be abused like any other slush fund. That's a Fully Generic Argument against any pool of government money for any purpose. The law could be written in such a way that the money is allocated for this specific purpose. > Plus there’s a natural adverse selection bias as all the “really good” patents will go the private route. A valid critique. The long-term goal, of course, would be to expand the program and phase out pharma entirely. An intermediate step would be to increasingly offer grants to academics with the stipulation "if you take this grant money, you must go the public route". In much the same way that now, any research published with NIH funds must be open-access within 1 (2? I forget) years. > The current pharma pricing system milks the American consumer so as to subsidize the rest of the planet. Yes, but... > The real answer to all of this is to pass a law that drug prices in the USA have to be less than anywhere else on earth. And you don't think this would negatively impact the rate of drug development? I do. Price controls are also a very drastic step in terms of American law. They tend to have...undesirable side-effects. If I were pondering general solutions in the area of what you are talking about, I'd prefer laws drastically limiting the amount and type of marketing pharma can do. And ideally supplement that with FDA-provided, more objective material for consumers and MDs about the actual, objective benefits and risks of various drugs.

kkreamer 7y ago

Not going to respond on the rest of your comment, but on insulin, I want to rebut the idea that generics are the same as "fancy and more convenient" versions. They are completely different drugs with different (and far worse) clinical outcomes. You might as well say "infected people won't have amputations like we've been doing forever. They must always have the fancy and more convenient antibiotics instead." The fact is, because of intrinsic differences in the types of insulin, a regimen of NPH and/or R can not help but have a significant increase in diabetic complications (including amputations, as in my statement above) than a basal/bolus regimen of Lantus/Levemir and Novolog/Humalog -- all of which have been available for something like 20 years and all of which have seen predatory price increases.

cgiles 7y ago
You are right, and I altered a comment below to reflect this. I was trying to make a more general point and phrased it poorly. The general point is: the reason drug costs are high because of two things working together: 1) Pharma continually refreshes patents by making modest, but real, improvements to things that are generically available. 2) Patients will not accept any level of increased health risk, no matter how much the cost increases in exchange for decreased risk. The result of these two things is that even though we have generics available for almost every major disease, they are rarely used, and we are always using the patented versions which are orders of magnitude more expensive. And then we have people wondering why health care is so expensive. It would be absolutely bizarre if it were any other area of the economy. Imagine if every person insisted on owning a sports car because they go 20% faster. But because we (the public in general) continue on insisting that no price can be placed on marginal increases human life or health -- despite the huge logical contradictions that result from this -- we cannot have rational discussions about how to actually keep health care affordable.
- kkreamer 7y ago
  I totally agree with you regarding drug prices overall, but insulin is different in this respect. A vial of Humalog cost $35 in 2001. The exact same size vial of the exact same insulin -- no refreshed patent, no reformulations, no improvements, no change whatsoever -- cost $270 in 2017. If the price would have only followed inflation, it would have been $48.50 in 2017.

MrFoof 7y ago

>And with insulin specifically, there is another problem: diabetics won't take the generic insulin that has been off-patent for years now. A huge reason I found is your doctor won't ever recommend it. Most diabetics may very well just be blissfully ignorant (I was until recently) that it's even an option, save for Wal-Mart very heavily marketing their "Reli-On" branded insulin produced by Novo Nordisk. I wonder if PCPs (not endocrinologists) are even aware it exists. I've had many PCPs in the past few years, from one of the best health care centers in the US, never recommend it as an option, and seemed to forget it even existed. I guess when you recommend Eli Lilly's biologic-developed analogs for decades and decades, you damn near forget about the old school insulin out of habit. I recently switched, WITHOUT a doctor's approval (none would recommend it). I have to be more careful, but my costs of using purely generic everything plummeted to below 1997-era insured levels Increasingly insurance co-pays have gotten far more expensive for the biologics, and increasingly plans don't even cover the biologic-process analogs anymore (where my costs would be $560/mo for just the insulins that aren't covered by my current plan, or $130/mo if I paid another +$230/mo for a better single-person insurance plan -- only a $170/mo net reduction). My uninsured "no prescription required" OTC costs for all my diabetic supplies (two insulins, sharps container, lancets, test strips) are $69/mo, and $18/mo (prescription required) for generic syringes now. It required taking everything in my own hands and telling every PCP I had to #$%& their hat.

conanbatt 7y ago

> Step #1 should be to give a huge wad of money to the FDA. Say $1B/yr. Then you tell the FDA: every year, pick the 50 most promising drug candidates. Publicly fund the clinical trials, and the public will own the patent. Give some cash to the inventor and the institute to incentivize them to do this scheme and not sell to pharma. I think the FDA is whats making drugs prohibitively expensive. First by disallowing the importation of drugs, second by putting a very conservative standard on the commercialization of drugs. You are right about something, the policy is unappealing for either side. The right doesn't want to give more money to the FDA, and the left doesn't care about giving a gov institution pocket money, they want to outright outlaw profits as a whole. Call yourself Elon because you are on Mars :)

Aloha 7y ago
The standard we have for drugs now was paid for in lives. Elixir Sulfonamide, Profusion of Barbiturate use in the 50's, Thalidomide (which the US missed because of our more stringent rules), Phen-Fen - I can go on.
- conanbatt 7y ago
  The standard you have now is also paid with lives. It's the people that can't get a drug in time or can't pay for it thats killing people.

refurb 7y ago

Say $1B/yr. Then you tell the FDA: every year, pick the 50 most promising drug candidates. Publicly fund the clinical trials, and the public will own the patent. What do you think the FDA knows about running clinical trials? They are obviously experts when it comes to regulatory aspects, but what about trial recruitment, monitoring, supply chain, etc? And what about the educational side? Doctors need someone to talk to, to explain the data, to answer a multitude of questions. It would take FAR more than $1B per year to have the FDA so all that. The Pharma industry spends $70B plus on R&D each year and they already have all the infrastructure. And don’t for one second believe that getting a drug to market is as simple as funding clinical trials. There is a ton of upkeep once approved - phase 4 trials, manufacturing tweaks, educating physicians and customers. 2019 FDA budget was $5.7B. I’d guess you’d need closer to 20x to replicate the work the pharma industry is doing, just on the R&D side, let alone everything else.