The risk capital funding drug development can go elsewhere. If you break the spreadsheet math of drug development, you won’t get cheaper drugs. You just won’t get drugs.
Why break the only system in the world consistently delivering 30–40 new drugs year after year?
Because absolute opinions on this are stupid. For every cutting edge cancer treatment we get, there’s another pharma company abusing their position to overprice specific drugs. Since the free market explicitly can’t rectify the situation (patents grant artificial monopolies, sick people have very little option to shop around) there should be some system to review and police the worst abuses. One can argue about whether this type of political review is the best, or if we should have a more structured approach (I would like that, tell Congress.) But just shouting that the current system is perfect and should be unrestricted is also a bad approach.
There is nothing free market about enforcing patent on parties that aren't signatory to it, nor the high regulatory impositions that choke out those who aren't suitably connected to regulatory capture apparatus.
Almost all of the research for these drugs was funded by taxpayer dollars. Taxpayer dollars are increasingly used to pay for early rounds of safety trials. Private capital now only pays for the late-round efficacy trials, which is the last step before commercial sales.
So we'll still get the drugs. We'd just have fewer rich pharma bros with multiple condos and yachts.
https://health-policy-systems.biomedcentral.com/articles/10.... ("The largest funder was the United States National Institutes of Health ($26.1 billion), followed by the European Commission ($3.7 billion), and the United Kingdom Medical Research Council ($1.3 billion).")
58% were funded in some fraction. I wonder what percent of approved drug cost is publically funded, and what percent is fulfilling regulatory requirements. The high cost is in large part government induced, so it's kind of hilarious to regulate this massive cost and then brag about helping to fund some fractional number.
I’d ask what is driving the high cost induced by government? There are Large rigorous studies required to support efficacy and safety, and rigorous manufacturing requirements to ensure consistent drug supply for example. For sure, Pharma needs to drop the DRC advertising crap, and rely more on data than the current level of marketing to physicians/patients . Making safe and innovative drugs is expensive. The drugs should go generic gracefully, and then become cheap after a reasonable time. That isn’t happening and Pharma also needs to drop the BS patent extensions.
All clinical studies are not equal so some nuance on the objective of the studies is probably important. My impression is that grant funded clinical studies tend to be earlier in development and more exploratory if interventional, or observational if larger (eg framingham study). This isn’t absolute, but the funding required to cover large definitive pivotal studies, and all pharm/tox and manufacturing needed for a drug approval is large and I believe is very unlikely to be covered by grants.
I agree NIH is essential and Pharma has some large issues, but I don’t believe NIH is teeing up loads of approvable drugs for industry to exploit.
Even though this is only funding for trials and not research, I have to admit that I didn’t expect that and I will concede that it would be on me now to prove that research funding is differently distributed.
I would say the NIH is probably the biggest funder, and those of us coming out of universities earlier in our career - that is where most of us think of asking for money first; mostly as that is the "standard" model of getting into academia (i.e. K grants, R grants, etc). That being said, it seems like there's a decent amount of patents from the private sector as well
Because those drugs are worthless if people can't afford them. It's also a bit silly to ignore the entire rest of the world's pharmaceutical R&D. Lots of people would gladly give up bragging rights on production metrics if it means they can live healthier lives.
The divide in US (and I suspect elsewhere) politics is not Left v Right, it's Stasis vs Dynamism. In this case the "progressives" are proposing a plan that will cause Stasis or even decline...
Comments
The administration neglects to mention that the march-in rights are subject to judicial review.
Here’s Birch Bayh and Bob Dole clarifying that the march-in rights in the Bayh-Dole Act do not grant the White House this authority based on price: https://www.washingtonpost.com/archive/opinions/2002/04/11/o...
The risk capital funding drug development can go elsewhere. If you break the spreadsheet math of drug development, you won’t get cheaper drugs. You just won’t get drugs.
Why break the only system in the world consistently delivering 30–40 new drugs year after year?
Because absolute opinions on this are stupid. For every cutting edge cancer treatment we get, there’s another pharma company abusing their position to overprice specific drugs. Since the free market explicitly can’t rectify the situation (patents grant artificial monopolies, sick people have very little option to shop around) there should be some system to review and police the worst abuses. One can argue about whether this type of political review is the best, or if we should have a more structured approach (I would like that, tell Congress.) But just shouting that the current system is perfect and should be unrestricted is also a bad approach.
There is nothing free market about enforcing patent on parties that aren't signatory to it, nor the high regulatory impositions that choke out those who aren't suitably connected to regulatory capture apparatus.
Almost all of the research for these drugs was funded by taxpayer dollars. Taxpayer dollars are increasingly used to pay for early rounds of safety trials. Private capital now only pays for the late-round efficacy trials, which is the last step before commercial sales.
So we'll still get the drugs. We'd just have fewer rich pharma bros with multiple condos and yachts.
That simply isn’t true.
Please provide citations with sources if you’re making extraordinary claims.
https://www.nih.gov/grants-funding
https://health-policy-systems.biomedcentral.com/articles/10.... ("The largest funder was the United States National Institutes of Health ($26.1 billion), followed by the European Commission ($3.7 billion), and the United Kingdom Medical Research Council ($1.3 billion).")
https://www.news-medical.net/life-sciences/Who-Funds-Clinica... ("58% of studies were funded by the government")
58% were funded in some fraction. I wonder what percent of approved drug cost is publically funded, and what percent is fulfilling regulatory requirements. The high cost is in large part government induced, so it's kind of hilarious to regulate this massive cost and then brag about helping to fund some fractional number.
I’d ask what is driving the high cost induced by government? There are Large rigorous studies required to support efficacy and safety, and rigorous manufacturing requirements to ensure consistent drug supply for example. For sure, Pharma needs to drop the DRC advertising crap, and rely more on data than the current level of marketing to physicians/patients . Making safe and innovative drugs is expensive. The drugs should go generic gracefully, and then become cheap after a reasonable time. That isn’t happening and Pharma also needs to drop the BS patent extensions.
All clinical studies are not equal so some nuance on the objective of the studies is probably important. My impression is that grant funded clinical studies tend to be earlier in development and more exploratory if interventional, or observational if larger (eg framingham study). This isn’t absolute, but the funding required to cover large definitive pivotal studies, and all pharm/tox and manufacturing needed for a drug approval is large and I believe is very unlikely to be covered by grants. I agree NIH is essential and Pharma has some large issues, but I don’t believe NIH is teeing up loads of approvable drugs for industry to exploit.
Fair point, especially in that 58% figure.
Even though this is only funding for trials and not research, I have to admit that I didn’t expect that and I will concede that it would be on me now to prove that research funding is differently distributed.
I would say the NIH is probably the biggest funder, and those of us coming out of universities earlier in our career - that is where most of us think of asking for money first; mostly as that is the "standard" model of getting into academia (i.e. K grants, R grants, etc). That being said, it seems like there's a decent amount of patents from the private sector as well
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9440766/
Because those drugs are worthless if people can't afford them. It's also a bit silly to ignore the entire rest of the world's pharmaceutical R&D. Lots of people would gladly give up bragging rights on production metrics if it means they can live healthier lives.
The divide in US (and I suspect elsewhere) politics is not Left v Right, it's Stasis vs Dynamism. In this case the "progressives" are proposing a plan that will cause Stasis or even decline...
Doing nothing (stasis) has resulted in lower affordability (decline). Your framing is equally valid and incomplete because it's not a binary choice.