Let's start off by saying I do not begrudge other disease groups access to treatment. I don't wish for people to suffer.
Now that's out of the way, I am really frightened by the prospect of Alzheimer's patients receiving IVIG as a treatment. The therapeutic dosage I've seen online is something like twice as much as the PIDD dose every two weeks, instead of monthly. There are already rumors of shortages and talk that we may see the worst plasma situation since 2005. 2005 was scary. People couldn't get treatment. Doctors could not locate product. Not a good thing. This shortage scare is happening now with (I would approximate) 1 million people using the product, all of them rare diseases. This shortage is happening in an economic slump when there have historically been more plasma donations because people are strapped for cash.
Why else does this concern me? Alzheimer's is a "fashionable" disease. It has name recognition, celebrity boosters, etc. Any development with Alzheimer's is huge news around the world. There are also 5.4 million people with Alzheimer's in the United States. Using two-four times as much product. It is worrisome that the Alzheimer's lobby might get legal protections for their use of IVIG, which would trump mine. We have very few advocates, Alzheimer's has many very powerful ones.
My best hope is that they would develop a monoclonal antibody for Alzheimer's that would target the beta ameloid protein, but that is years of very challenging science down the road.
IVIG is the only treatment for CVID. There is nothing else even in the pipeline to treat me.
There is no reason to be concerned. the US is a large exporter of plasma and everyone of the manufacturers has tons of extra capacity. The extra plasma collection capacity was developed in response to the crisis of 2005-6. I even think there are several manufacturing plant built in the US.
ReplyDeleteThe bottleneck in 2005 was plama collection. by law all IG sold in the US my be made from plasma collected in the US. The processing can be done outside of the US, Hizentra is an example, but all the plasma must be domestic. It takes about three to five years for a campany's decision to build a new plasma collection facility to get finished product to market. First the permits, then the building (an investment of about $5-10 million), getting the collection facility licensed by the FDA, only then can the plasma they collect start on the one year quarantine and manufacturing / distribution process.
I think you're absolutely wrong about this being solvable by not exporting plasma. As I said, in a generous estimate 1 million people use plasma products already. I would actually say that's probably more accurately a worldwide number. We already experience issues getting plasma donations, as you admit there was a problem with plasma collection previously. There's no way the pharmaceutical companies will be able to get enough plasma to satisfy even just the Alzheimer's community, let alone the people who need it for autoimmune disease and the PIDD community.
DeleteWe'll shoot the middle of the "average" weight between the two sexes and say the average person is about 80 kg. By the dose math I've seen, the "average" Alzheimer's patient would need 160 g every 2 weeks. Let's be generous and say plasma donors can do 5 g per week. That would require 32 plasma donors for each Alzheimer's patient. If my math is correct, it would require 172.8 million plasma donors just to keep pace with the "average" demand for Alzheimer's patients.
I would like to suspend reality for a moment and be overly hopeful, suggesting that instead of the lobbyists being a problem, that instead, when it is realized how intrusive (frequent, time consuming) and generally not fun this treatment is for Alzheimer's patients, instead of lobbying for protections for IVIG for said patients, they will instead lobby for a new version of this treatment that is faster, less costly, less intrusive, etc, so that it is more beneficial for Alzheimer's patients. Then the other million that currently benefit from these treatments for other reasons now can in the future benefit from the advances. I'll take off the rose colored glasses later :)
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