Such studies are great but there is no regulatory pathway to extend the use of existing drugs for new indications of use without the consent of the manufacturer (or becoming a manufacturer yourself).
This means such studies can give more clarity on which off-label use is beneficial but it can't be an officially allowed usage.
I have been a supporter of Cures Within Reach, a nonprofit that focuses on repurposing drugs, especially for rare diseases. https://www.cureswithinreach.org
They have funded some important repurposed-drug studies for Huntingtons Disease, which runs in my family. For a disease like this, it's never going to make sense for major pharmaceutical companies to invest the effort to develop entirely new drugs, but by repurposing existing drugs, it gives people living with rare diseases a chance to ease symptoms.
the thing is while something is better than nothing, new drug development is critical
there is absolutely no cure for certain types of long-covid and me-cfs right now
no repurposing any drug is going to cure it, they've tried everything after six years
it will take a decade to have anything even in the pipeline and won't emerge from the USA because all medical and science research investment by the government has been destroyed by Russell Vought and Heritage Foundation
JAK-STAT inhibitors will be a big treatment, not a cure, but they cost thousands per month in the USA because generics aren't allowed
fascinating! I'm sure there's quite a bit that can be learned through appropriate research - pathways to solve problems that haven't been thought of before
The prices of drugs in the USA are especially high. This is interesting
because the USA claims to pursue a maximum capitalistic society - but if
this were the case, you'd have competition in a free market. But you don't
have that. You have a cartel (or rather more than one).
A pure capitalistic society works on assumptions that are not real. People
are often cheaters. This would have to be taken into account. But when you
have an orange Al Capone in charge, it is pillage day. Even before the orange
King you had heavily overcharged prices in the health care system. You need
to realise that you have a mafia in charge that does not want to change this
system. Why kill the cow that you can milk for free?
I tried health-tech twice. Opted out both times as there are too many misaligned incentives and useless rent-takers supported by Congress and other entrenched players.
At this point maybe the best solution is door to door doctors using AI.
If every drug created with taxpayer dollars at government-funded research institutions was open-sourced, there would be a collapse in monopoly control of drug manufacturing and that would lower prices significantly.
The question is then, if corporations can no longer acquire IP rights to drugs created by taxpayer-funded research programs and transferred to their exclusive control (eg if Bayh-Dole is repealed in the USA), who will invest in clinical trial costs that need to be recouped via a period of inflated pricing?
The answer is government-funded, transparent, and statistically-robust clinical trials of drugs. Once a clinical trial is complete, private manufacturers can compete to produce the drugs at the lowest price by optimizing their manufacturing pipelines against a final product standard regulated by the FDA. If they want to run their own R & D divisions for drug development outside the taxpayer-financed university system to generate exclusive private patents, they certainly can - on their own dime. That’s an investment decision.
If you need to review why this government-linked, tightly regulated system is needed for drugs with clinical effects, just look up ‘patent medicine disasters of the early 20th century’.
I’m currently on Spravato, which is fully emblematic of how broken the incentives in the US healthcare system are.
Spravato is esketamine - a modified version of ketamine. Ketamine is made up of mirror image molecules and esketamine is the right-handed molecule. They did this because ketamine is off-patent so they needed to modify it in order to patent it, however there is evidence that esketamine is a less effective treatment than ketamine.
It’s very cheap for me but my insurance company pays about $17k a month for this treatment. Ketamine would be a more effective treatment that would be super cheap for them, but they don’t do it because it’s not FDA-approved. So they’re paying a fortune for a less effective treatment.
It would be in the insurance companies’ interests to band together to fund the research so they can save huge amounts of money in the long term but they do not do this.
What’s so interesting about this that I just learned after googling about Spravato that ketamine is a treatment for serious depression. Why? That’s fascinating! Is it the dissociative effects?
the opiate receptor interaction might be important, but it seems that the antidepressant effect persists even if the opiate pathway is blocked (via naltrexone)
I have a little insight here from working with ophthalmologists.
When the article mentions "using a cancer drug to treat a leading cause of blindness" it's talking about using Bevacizumab (brand name Avastin) to treat macular degeneration.
Avastin and Lucentis are molecularly the same drug. The difference is that Avastin isn't packaged to be injected into eyeballs, and Lucentis is. Also, Avastin costs about $50/dose, and Lucentis costs around $1,500/dose.
There are compounding pharmacies that will repackage Avastin into a format that can be injected into eyeballs.
However, many ophthalmologists are hesitatnt to use Avastin because that process introduces the potential for contamination. Not that it happens frequently, but every ophthalmologist I know lives in fear of introducing an infection into their patient's eyeballs. And what level of risk is worth saving $1,450 per dose on an injection? 1/100? 1/1000?
I know at least one ophthalmologist who would use Avastin, but would culture a sample from every batch she got from the compounding pharmacy, and had at least one batch that cultured bacteria.
Assumedly, if she hadn't, every patient she injected with that batch would have been at risk of contracting endophthalmitis, and endophthalmitis is no joke. Not infrequently, it can mean losing vision.
I know several of that ophthalmologist's colleagues who had been using compounded Avastin to try and save their patients money, stopped after that incident.
I don't really have a conclusion beyond "drug pricing is insane and the issue is complex for providers."
> And what level of risk is worth saving $1,450 per dose on an injection? 1/100? 1/1000?
I've have plenty of friends that would struggle to afford that. I have friends that buy black market drugs because they can't get/afford a prescription. I don't know if I would make the same choice but I can I can understand why some people do.
You can get some branded prescription pharmaceuticals in the U.S. from outside the U.S. via workarounds (1), and find heavily tested peptides via (2), in both cases avoiding the worst of the black or gray markets. If peptides, it's worth passing the hurdles and tests to access resources at https://pep-pedia.org/
(1) Start by filtering for Brand (not generic) and then going though lowest-cost results for reliable branded manufacturing locations (e.g. Germany, New Zealand, Singapore, NOT India) at https://www.pharmacychecker.com/ . Some sources are less picky about accurately checking prescriptions (e.g. https://www.inhousepharmacy.vu/ ). US Gov't allows buying outside U.S. for personal use, but reserves right to block incoming packages, but practically speaking does not.
The higher manufacturer price of the eyeball-safe formulation is clearly justified, then, i.m.o. Also, is it the doctor's responsibility to assume risk to save the patient money?
The reason people get endophthalmitis is rarely due to a contaminated batch, but it certainly happens. But frankly it’s unsustainable to have all patients on branded drug, it would be too costly for patients and payers. Not to mention it is slightly unethical in the US due to drug rebates incentivizing branded drug use.
Endophthalmitis is bad, but we can treat it if caught promptly. Patient education, informed consent, good hygiene practices, and easy access to their ophthalmologist can make a tremendous difference.
> Not to mention it is slightly unethical in the US due to drug rebates incentivizing branded drug use.
This is an area I'm only perephrially aware of, but the way I understand it is:
* Manufacturer sells very expensive injectible eye drug, in the range of $2k/injection.
* It's typically covered by insurance, but patients (in this demogrpahic who are often on medicare) can still have high deductibles and copayments/coinsurance costs.
* To get around this, the manufacturer funds a nonprofit organization that patients can apply to for financial help paying for their deductibles.
* The manufacturer gets a write-off for donating to a nonprofit, and while they might cover, say, $2k or $5k of a patient's deductible over the course of a year, they still get $22k in revenue covered by Medicare for a year's worth of injections for that patient.
* There was some issue recently where maybe someone realized that "a charity funded by a drug manufacturer exclusively for the purpose of reimbursing purchases of that manufacturer's drugs" might not be a wholly above board charity, but I'm not sure if that was resolved.
All this is hearsay from my perspective, but am I in the ballpark of what you were talking about?
Yes, but it's really tough. I read that 50% of Stanford Medical School budget comes from Big Pharma. It's really hard to get the message out. I believe Pharma (the biggest advertiser on Google) is influencing Google search results, among other things.
universal health care can be offered even in 3rd world countries but they're really smart about keeping costs low. they drastically cut the costs of medical service by just offering one or two generic drugs bbought in bulk from china and india rather than all those custom expensive drugs that do the same thing. it does the same thing but at a much lower cost
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[ 2.9 ms ] story [ 66.7 ms ] threadThis means such studies can give more clarity on which off-label use is beneficial but it can't be an officially allowed usage.
They have funded some important repurposed-drug studies for Huntingtons Disease, which runs in my family. For a disease like this, it's never going to make sense for major pharmaceutical companies to invest the effort to develop entirely new drugs, but by repurposing existing drugs, it gives people living with rare diseases a chance to ease symptoms.
there is absolutely no cure for certain types of long-covid and me-cfs right now
no repurposing any drug is going to cure it, they've tried everything after six years
it will take a decade to have anything even in the pipeline and won't emerge from the USA because all medical and science research investment by the government has been destroyed by Russell Vought and Heritage Foundation
JAK-STAT inhibitors will be a big treatment, not a cure, but they cost thousands per month in the USA because generics aren't allowed
A pure capitalistic society works on assumptions that are not real. People are often cheaters. This would have to be taken into account. But when you have an orange Al Capone in charge, it is pillage day. Even before the orange King you had heavily overcharged prices in the health care system. You need to realise that you have a mafia in charge that does not want to change this system. Why kill the cow that you can milk for free?
At this point maybe the best solution is door to door doctors using AI.
The question is then, if corporations can no longer acquire IP rights to drugs created by taxpayer-funded research programs and transferred to their exclusive control (eg if Bayh-Dole is repealed in the USA), who will invest in clinical trial costs that need to be recouped via a period of inflated pricing?
The answer is government-funded, transparent, and statistically-robust clinical trials of drugs. Once a clinical trial is complete, private manufacturers can compete to produce the drugs at the lowest price by optimizing their manufacturing pipelines against a final product standard regulated by the FDA. If they want to run their own R & D divisions for drug development outside the taxpayer-financed university system to generate exclusive private patents, they certainly can - on their own dime. That’s an investment decision.
If you need to review why this government-linked, tightly regulated system is needed for drugs with clinical effects, just look up ‘patent medicine disasters of the early 20th century’.
Spravato is esketamine - a modified version of ketamine. Ketamine is made up of mirror image molecules and esketamine is the right-handed molecule. They did this because ketamine is off-patent so they needed to modify it in order to patent it, however there is evidence that esketamine is a less effective treatment than ketamine.
It’s very cheap for me but my insurance company pays about $17k a month for this treatment. Ketamine would be a more effective treatment that would be super cheap for them, but they don’t do it because it’s not FDA-approved. So they’re paying a fortune for a less effective treatment.
It would be in the insurance companies’ interests to band together to fund the research so they can save huge amounts of money in the long term but they do not do this.
https://lorienpsych.com/2021/11/02/ketamine/#11_How_does_ket...
the opiate receptor interaction might be important, but it seems that the antidepressant effect persists even if the opiate pathway is blocked (via naltrexone)
https://pmc.ncbi.nlm.nih.gov/articles/PMC6439824/ (though it's an open-label super small study ... n=4)
When the article mentions "using a cancer drug to treat a leading cause of blindness" it's talking about using Bevacizumab (brand name Avastin) to treat macular degeneration.
Avastin and Lucentis are molecularly the same drug. The difference is that Avastin isn't packaged to be injected into eyeballs, and Lucentis is. Also, Avastin costs about $50/dose, and Lucentis costs around $1,500/dose.
There are compounding pharmacies that will repackage Avastin into a format that can be injected into eyeballs.
However, many ophthalmologists are hesitatnt to use Avastin because that process introduces the potential for contamination. Not that it happens frequently, but every ophthalmologist I know lives in fear of introducing an infection into their patient's eyeballs. And what level of risk is worth saving $1,450 per dose on an injection? 1/100? 1/1000?
I know at least one ophthalmologist who would use Avastin, but would culture a sample from every batch she got from the compounding pharmacy, and had at least one batch that cultured bacteria.
Assumedly, if she hadn't, every patient she injected with that batch would have been at risk of contracting endophthalmitis, and endophthalmitis is no joke. Not infrequently, it can mean losing vision.
I know several of that ophthalmologist's colleagues who had been using compounded Avastin to try and save their patients money, stopped after that incident.
I don't really have a conclusion beyond "drug pricing is insane and the issue is complex for providers."
I've have plenty of friends that would struggle to afford that. I have friends that buy black market drugs because they can't get/afford a prescription. I don't know if I would make the same choice but I can I can understand why some people do.
(1) Start by filtering for Brand (not generic) and then going though lowest-cost results for reliable branded manufacturing locations (e.g. Germany, New Zealand, Singapore, NOT India) at https://www.pharmacychecker.com/ . Some sources are less picky about accurately checking prescriptions (e.g. https://www.inhousepharmacy.vu/ ). US Gov't allows buying outside U.S. for personal use, but reserves right to block incoming packages, but practically speaking does not.
(2) Filter for vendors with the best results at https://www.finnrick.com/about/testing-methodology
Endophthalmitis is bad, but we can treat it if caught promptly. Patient education, informed consent, good hygiene practices, and easy access to their ophthalmologist can make a tremendous difference.
Source: I do these injections for a living.
This is an area I'm only perephrially aware of, but the way I understand it is:
* Manufacturer sells very expensive injectible eye drug, in the range of $2k/injection.
* It's typically covered by insurance, but patients (in this demogrpahic who are often on medicare) can still have high deductibles and copayments/coinsurance costs.
* To get around this, the manufacturer funds a nonprofit organization that patients can apply to for financial help paying for their deductibles.
* The manufacturer gets a write-off for donating to a nonprofit, and while they might cover, say, $2k or $5k of a patient's deductible over the course of a year, they still get $22k in revenue covered by Medicare for a year's worth of injections for that patient.
* There was some issue recently where maybe someone realized that "a charity funded by a drug manufacturer exclusively for the purpose of reimbursing purchases of that manufacturer's drugs" might not be a wholly above board charity, but I'm not sure if that was resolved.
All this is hearsay from my perspective, but am I in the ballpark of what you were talking about?
Here is a site that focuses on COVID and Cancer: https://imahealth.org/