Three Months Of New Studies

I’ve been following Dr. Faustman for over 10 years, and have published 19 blogs on her work over that time. You can read them all here:

But if you only have time to read two or three, I’d focus on these:

I’m happy to discuss any aspect of this work with you, especially if you have any specific questions about it.

But if you want a quick summary of her most recent publication, these would be my opinions:

  • In terms of a cure, Dr. Faustman’s human trials are moving away from a cure, not towards one. Her C-peptide data from her phase-I trial years ago was tiny, but in the right direction. Her most recent C-peptide data from that same trial shows no improvement (not even the tiny goodness that was seen before).

  • Her phase-II trial is not using C-peptide data as either a primary or secondary outcome. C-peptide is the standard measure for progress to a cure, so not having it as a primary or even secondary outcome means this research is no longer “aimed a curing type-1 diabetes”.

  • Even worse, her Phase-II study originally was originally going to measure C-peptides, however she dropped that a few years ago. The primary end point is now A1c data, but A1c is the measure of better treatment, not a cure.

  • The good results reported were very time dependent, and inconsistent. The results at 4 years were good, and that is what she talks about. But the results at 2 years were bad, and she does not talk about those. The most likely cause of all this (in my opinion) is randomness of the disease. We all have better and worse times with type-1 diabetes. If the vaccine had any impact at all, then the impact is to make A1cs worse for the first few years, better for the next few, and then start to move back to were they started. (You can see the graphs in my blog.)

  • Her good results are due to a bad-science technique called “results swapping”. She started out studying one set of results (autoreactive t-cells, c-peptides, TNF, etc.) but none of those gave good results, so she ended up publishing data on A1c numbers, which was not part of the study to start with, and the study was not designed to report on those.

  • In her most recent paper, she said very specifically that her TNF theory, which she has been working on for 10+ years was not causing the results seen in studies. She proposed an alternate theory, but that alternate theory is one of treatment, not cure. It is similar to some of the type-2 treatments available now.

My most recent blog posting on her work goes into a lot more detail about how badly things are going, and the misleading language used in her most recent press release.

Joshua

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