Maybe this is what’s needed to restore some sense to the insulin supply business.
This will be interesting. Our government has not been very successful in addressing the problems with drug pricing. Just as Mark Cuban started his company to try to help, innovative ways seem to be needed. But given that…anything would be good, but a lot of the insulins we love are under patents, you can get a cheap insulin at Walmart.
But I have a feeling California isn’t doing it just to “help” They have a large population and a huge amount of people on MediCal that they pay for. They also have one of the largest populations of illegal immigrants that are usually covered with different programs. Many type 2’s that are put on insulin being covered. So manufacturing their own might save them a lot of money. I just really wonder what kind of insulin it will it be? But I guess it’s a start.
My thoughts exactly. Government has had trouble with follow through on initiatives like this so it will be interesting to see how it goes. If they can pull it off in a meaningful way more power to them.
I’m a big fan of an ideal economy where many companies in a market compete based on quality, good management, and fundamental benefits to the consumer. This fairy-tale understanding sets the price at an optimal and attractive level to the consumer.
Unfortunately the US market for analog insulin that many of us use is trapped by too few competitors (3 control almost all of the analog business) and it operates as an oligopoly. It is the main driver of the insanely high prices. Many other factors including the payers and pharmacy benefit managers play a role for sure. I see it as a market sickness.
If California can produce a competitive product, it could deliver a way to bust up this oligopoly. I believe that the state’s success could not only benefit itself and insulin users but also the competitors themselves.
If any state can do it, California can.
Sounds more like a fake butter that won’t raise BG rather than a market structure
This is a ploy to encourage the big companies to play ball.
Companies like Lilly and Novo have been sticking it to big states like california a long time so the threat of competition might just be enough to get them to lower costs.
There are options…
The last several years I have used Novolog $99 insulin program, for up to 3 vials per month.
How do you do that?
I learned about it from another diabetes forum. Some doctors may also be aware of various programs.
Here is the novocare offer
How does this impact the Mayo’s efforts to manufacture in Utah? Mayo is starting w/ insulin, but their long term goal is to make super expensive cancer drugs. What made this possible where it wasn’t before? Is insulin easy to make (compared to other drugs)? Is this the country brining manufacturing back to the US?
Its a drug making FREE FOR ALL! How exciting/interesting.
They now have three different strategies at play - public, private, and a mix between public & private. This is gonna happen. This is some serious healthcare disruption.
Does this have anything to do with the government involving itself in the drug supply chain due to covid vaccination production?
Insulin manufacture is not a simple process but it’s been pretty well automated.
First they take bacteria. And they transfect it by removing its nuclear dna and replacing it with the dna of human pancreatic cells. That’s the most difficult part.
Then they allow the cells to field and grow. Their waste is insulin. Then they remove all the cell debris and left with insulin.
The dna that they use determines the type of insulin produced.
Then there are additives to make it last longer or shorter
This process has been going on for 40 years so it’s about time we saw some competition.
From the original notes on purifying animal pancreases to make insulin, from 1922:
“The present method of preparation is as follows. The beef or pork pancreas is finely minced in a larger grinder and the minced material is then treated with 5 c.c. of concentrated sulphuric acid, appropriately diluted, per pound of glands. The mixture is stirred for a period of three or four hours and 95% alcohol is added until the concentration of alcohol is 60% to 70%. Two extractions of the glands are made. The solid material is then partially removed by centrifuging the mixture and the solution is further clarified by filtering through paper. The filtrate is practically neutralized with Sodium Hydroxide. The clear filtrate is concentrated in vacuo to about 1/15 of its original volume.
The concentrate is then heated to 50o degrees Centigrade, which results in the separation of lipoid and other materials, which are removed by filtration. Ammonium sulphate (37 grams. per 100 c.c.) is then added to the concentrate and a protein material containing all the Insulin floats to the top of the liquid. The precipitate is skimmed off and dissolved in hot acid alcohol. When the precipitate has completely dissolved, 10 volumes of warm alcohol are added. The solution is then neutralized with NaOH and cooled to room temperature, and kept in a refrigerator at 5oC for two days. At the end of this time the dark coloured supernatant alcohol is decanted off. The alcohol contains practically no potency. The precipitate is dried in vacuo to remove all trace of the alcohol. It is then dissolved in acid water, in which it is readily soluble. The solution is made alkaline with NaOH to PH 7.3 to 7.5. At this alkalinity a dark coloured precipitate settles out, and is immediately centrifuged off. This precipitate is washed once or twice with alkaline water of PH 9.0 and the washings are added to the main liquid.
It is important that this process be carried out fairly quickly as Insulin is destroyed in alkaline solution. The acidity is adjusted to PH 5.0 and a white precipitate readily settles out. Tricresol is added to a concentration of 0.3% in order to assist in the isoelectric precipitation and to act as a preservative. After standing one week in the ice chest the supernatant liquid is decanted off and the resultant liquid is removed by centrifuging. The precipitate is then dissolved in a small quantity of acid water.
A second isoelectric precipitation is carried out by adjusting the acidity to a PH of approximately 5.0. After standing over night the resultant precipitate is removed by centrifuging. The precipitate, which contains the active principle in a comparatively pure form, is dissolved in acid water and the hydrogen ion concentration adjusted to PH 2.5. The material is carefully tested to determine the potency and is then diluted to the desired strength of 10, 20, 40 or 80 units per c.c. Tricresol is added to secure a concentration of 0.1 percent. Sufficient sodium chloride is added to make the solution isotonic. The Insulin solution is passed through a Mandler filter. After passing through the filter the Insulin is retested carefully to determine its potency. There is practically no loss in berkefelding. The tested Insulin is poured into sterile glass vials with aseptic precautions and the sterility of the final product thoroughly tested by approved methods.”
(Note: I did not develop this process. Just internet copied an pasted. But I will say that even my undergraduate biology, chemistry, and organic chemistry courses would not make me an expert at this!!)
California could also just decide to leverage the work from OpenInsulin.org as a head start. They have been biohacking insulin since 2015 in Oakland.
@MBW You are aware that the process you detail above hasn’t been used in the USA in nearly 20 years? Bovine insulin production was halted in 1998 while porcine insulin’s stopped being produced in 2006.
Since then recombinant human insulins and their analogs are the only FDA-approved insulin’s available for the treatment of type 1 and 2 diabetes mellitus.
Haha yeah, I know. Here’s a link to THAT process.
Way more complicated!! Wish me luck . .
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Except when you’re the state, and set the Medicaid and Medicare formularies for everyone covered by a government insurance policy in your state… It’s pretty easy to guarantee your production facility pays for itself and turns a profit. They have the power to move the brand names to a different tier, and/or require prior authorization hoop jumping to get them, discouraging most people from straying from their own product line.
I’m good with biosimilars. Since the patents are expired on Humalog, Novolog, and Lantus, they’d likely be producing near identical formulas of those. Probably not both rapid-acting ones. I’d like to see where this goes. Wonder if they intend to sell outside the state, too.
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@Robyn_H But I believe they can change one thing in Humalog or Novolog “improve it” and can continue a patent on that? But also patent the same drug for a different use? Not saying this would happen but say Humalog patented for insulin for diabetics, but then patented to use to gain muscle?
But with the patents running out I am wondering if that is why we are seeing the discount cards hit from the manufacturers. Trying to do what they call a soft landing, so once the patent ends you don’t see a dramatic price drop. Or bringing out a generic formula with a slight change now for the same reason.