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Insulin is way too expensive. California has a solution: Make its own

vox.com

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Re: Insulin is way too expensive. California has a solution: Make its own

#81

Post by outworlder »

r3trohack3r wrote: post #69

> Though insulin generally costs less than $10 per dose to produce, some versions of the drug have a list price above $200. This is in part because, in the US, a warped market has allowed three companies to dominate the insulin business. > With California leading the way, a handful of states are considering trying to disrupt the market for essential medications, starting with insulin. The plan would be to manufacture…

> Is California just going to ignore these intellectual property laws? How will the state not be liable for damages when individuals are?

Insulin can be made without breaking patents. Unless you specifically require something branded as Lantus®, for example(which is in no small part due to publications funded by pharmaceutical companies themselves, but also some 'marketing' straight to doctors). There are other longer lasting insulin formulations that can be made.

There are hurdles if you take that route (as described in the article). Many are financial. One is regulatory (biosimilars).

Re: Insulin is way too expensive. California has a solution: Make its own

#82

Post by ak217 »

r3trohack3r wrote: post #69

> Though insulin generally costs less than $10 per dose to produce, some versions of the drug have a list price above $200. This is in part because, in the US, a warped market has allowed three companies to dominate the insulin business. > With California leading the way, a handful of states are considering trying to disrupt the market for essential medications, starting with insulin. The plan would be to manufacture…

Nothing weird about that, it's the essence of federalism. The resilience of the American system of government is attributable in large part to federalism, the marketplace of ideas from the states competing with each other.

There is no patent on insulin, just regulatory capture on which proprietary analogs are approved for medical use. In 2020 the FDA changed the regulatory status of insulin, signaling that it's not going to let that regulatory capture continue. But if it does, there will be a lawsuit, it will go to the Supreme Court, and the pharma companies' arguments will probably get thrown out.

Re: Insulin is way too expensive. California has a solution: Make its own

#83

Post by outworlder »

gamblor956 wrote: post #74
r3trohack3r wrote: post #69

> Though insulin generally costs less than $10 per dose to produce, some versions of the drug have a list price above $200. This is in part because, in the US, a warped market has allowed three companies to dominate the insulin business. > With California leading the way, a handful of states are considering trying to disrupt the market for essential medications, starting with insulin. The plan would be to manufacture…

Insulin pricing isn't entirely IP issue; it's been out of protection and available as a generic for many decades now. The issue is that while insulin is actually quite cheap to make once you get started, the startup-costs associated with getting to that point are quite hefty: lab real estate, equipment to make and purify, FDA fees, etc. Newer versions of insulin are "better" than generic insulin: easier to take, fewe…

> Newer versions of insulin are "better" than generic insulin: easier to take, fewer side effects, etc.

Even that is debatable. At least Sanofi has been known to fund some rosy articles about their Lantus® product. When the EU looked into it (for similar initiatives) they were not able to find the large 'performance' gap that was suggested between that insulin and alternatives.

Re: Insulin is way too expensive. California has a solution: Make its own

#84

Post by voakbasda »

r3trohack3r wrote: post #69

> Though insulin generally costs less than $10 per dose to produce, some versions of the drug have a list price above $200. This is in part because, in the US, a warped market has allowed three companies to dominate the insulin business. > With California leading the way, a handful of states are considering trying to disrupt the market for essential medications, starting with insulin. The plan would be to manufacture…

IANAL, but they may not be ignoring those laws; they may be planning to fight them. That cannot happen without standing, which may be easiest to obtain by trying to move forward with this plan.

I suspect they would be breaking federal laws, so I believe consideration of the State's 10th Amendment rights applies here. That would be wonderful and hope that this case brings that topic into the spotlight, because I see 90% of the federal government as being grossly unconstitutional on that basis alone.

Personally, I suspect the market leaders would not want to face the courts, because the exposure would be horrible PR that affects all of their product lines. Moreover, an aggressive and concerted effort to block this effort should be viewed as the anti-competitive behavior of a cartel, which is the status quo de facto that the State is effectively trying to disrupt.

I don't see such a challenge as anything but a lose-lose for those companies. Hopefully, they take the bait and do something stupid that leads to reform at the national level.

Re: Insulin is way too expensive. California has a solution: Make its own

#86

Post by outworlder »

dmreedy wrote: post #25
yonran wrote: post #15

I listened to the Vox The Weeds podcast interviewing the same author and was frustrated that his many explanations seemed disconnected. Since old insulin patents have expired, is it that you are allowed to buy generic insulin but there are no manufacturers, or that you not allowed to buy generic insulin because recent advancements are so good that doctors won’t prescribe the old stuff anymore? And no one will make ge…

You are allowed to buy generic/affordable "older" varieties of insulin. It can be got at Walmart for $25 per vial. It is a "regular insulin" as opposed to the more modern insulin analogs; a functional but inferior technology that requires a very restrictive and rigid diet, as opposed to modern combinations of fast and slow acting analogs that allow for something closer to a "normal", albeit carb-cautious diet. It wil…

> Regular / NPH

That's what my brother used to take 20 years ago.

They are not exactly 'inferior technology' and there are uses for them. But you are right that diabetics these days don't generally take them.

There are generic long lasting insulin alternatives, but none that I know of are available in the US. I believe that's what CA wants to do.

Re: Insulin is way too expensive. California has a solution: Make its own

#87

Post by ProjectInsulin »

rayiner wrote: post #73
r3trohack3r wrote: post #69

> Though insulin generally costs less than $10 per dose to produce, some versions of the drug have a list price above $200. This is in part because, in the US, a warped market has allowed three companies to dominate the insulin business. > With California leading the way, a handful of states are considering trying to disrupt the market for essential medications, starting with insulin. The plan would be to manufacture…

> I don't understand. My understanding of why insulin is so expensive: intellectual property laws are enforced by the government preventing businesses without that intellectual property to compete in the space. That’s not an accurate understanding of intellectual property specifically. Insulin isn’t like a pill, where once you have a chemical formula you can make millions of them very cheaply. It’s a biologic, an art…

Hi Rayiner, you are spot on with your analysis. My name is Eric, and my non-profit, Project Insulin, is tackling this problem head-on as well. We are developing a biosimilar insulin and will distribute it directly to patients at cost. The drug development process is still expensive but much cheaper because of the Biologics Act that was passed in 2020. When going through the FDA approval process, biosimilar insulin makers don't have to do phase 2 trials, and their phase 1 & phase 3 are focused on interchangeability with the reference product rather than proving that insulin is a way to lower high blood sugars.

Another obstacle, as you pointed out, is that there are few manufacturers who produce synthetic insulins. From what I've learned in my discussions with manufacturers is that many are transitioning their facilities to a focus on mRNA drug manufacturing. Therefore there is a limited set of manufacturers who don't make insulin but have the equipment/facilities for it (in the U.S.).

Re: Insulin is way too expensive. California has a solution: Make its own

#88

Post by plussed_reader »

ak217 wrote: post #82
r3trohack3r wrote: post #69

> Though insulin generally costs less than $10 per dose to produce, some versions of the drug have a list price above $200. This is in part because, in the US, a warped market has allowed three companies to dominate the insulin business. > With California leading the way, a handful of states are considering trying to disrupt the market for essential medications, starting with insulin. The plan would be to manufacture…

Nothing weird about that, it's the essence of federalism. The resilience of the American system of government is attributable in large part to federalism, the marketplace of ideas from the states competing with each other. There is no patent on insulin, just regulatory capture on which proprietary analogs are approved for medical use. In 2020 the FDA changed the regulatory status of insulin, signaling that it's not g…

[flagged]

Re: Insulin is way too expensive. California has a solution: Make its own

#89

Post by HDThoreaun »

r3trohack3r wrote: post #69

> Though insulin generally costs less than $10 per dose to produce, some versions of the drug have a list price above $200. This is in part because, in the US, a warped market has allowed three companies to dominate the insulin business. > With California leading the way, a handful of states are considering trying to disrupt the market for essential medications, starting with insulin. The plan would be to manufacture…

Insulin is off patent. There are new versions that offer a variety of benefits under patent, but just generic insulin can be made by anyone who passes the governments regulations. Walmart is known for offering generic insulin at lower prices.
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