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Betsy McDonel Herr, Ph.D.'s avatar

Immune tolerance hasn't been talked about enough, I remember you describing it many months ago. It is different than ADE as I understand it and the concept could use its own standalone Substack explainer post.

"Platform." Another great love affair that big tech has with their conceptual paradigm. Now yet another word in modern lexicon taking on negative and sinister connotations.

All this talk of approving a generic manufacturing process and platform should highlight the extensive and informative work that Hedley Rees and his colleagues are doing in the area of education about pharma manufacturing traditions, good manufacturing processes, and time honored and vetted rules and regulations that are all now being violated, willfully upended and revoked. It is tedious material, and there aren't so many great cartoons to share on the topics (maybe someone can think of some) but writers and activists in this technical domain also need to be participating in these live roundtables around the world to raise awareness and advocacy. There was a young blonde whistleblower early on that was sidelined when she called out manufacturing variation she witnessed in vials--particulates and blue green glow in the dark. Also blinds drawn and products being added to vials she wasn't briefed about. She should re-enter the conversation. Is that part of the "platform's" pre-approved flexibility? Wide variation and tolerances in manufacturing, distribution and handling?

https://hedleyrees.substack.com/?utm_source=substack&utm_medium=web&utm_campaign=profile_page

Dr. Ryan Cole just spoke this week at the World Council for Health Press Conference hosted by Dr. Tess Lawrie. Near the end or in the Q & A he discussed and acknowledged the shocking variation in manufacturing and in handling of lots that he believes led in part to variation in patient outcomes. In fact he thinks the lucky ones got the expired "duds" as they were potentially less potent.

https://worldcouncilforhealth.org/newsroom/

So the idea that the platform is good to go, no problems here, is preposterous.

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Micheal Nash, Ph. D.'s avatar

I agree with you about immune tolerance. Working on an immunotherapy study on ovarian cancer we were following Rosenberg's methodology for treating metastatic melanoma with tumor infiltrating t-cells (TIL). I came across some very iffy data suggesting clonality in t-cells isolated from our patients and that got me to wondering if there might not be a problem in trying to use t-cells comfortable with that site and hence not so eager to attack tumors originating there, i.e. site specific tolerance.

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Betsy McDonel Herr, Ph.D.'s avatar

Wow that sounds like a subset topic--site specific immune tolerance --to discuss in the Immune Tolerance module. I imagine that now and in the future many of these fantastic Substack posts will be circulated or repurposed like small educational internet pamphlets, and it is helpful for them to be parsed apart. If organized that way maybe people will find you more specifically for input.

I understand that Dr. Pierre Kory was able to harvest material from his own Substack and thoughts generated by commentary for his new book on Ivermectin.

Someday maybe Substack will be searchable for concepts, words, and such. I saw that being called for by commenters in Meryl Nass's recent Substack focused on censorship last week raising concerns about Substack itself.

Good luck on your study. I am thinking there will be plenty of ovarian cancer to manage going forward.

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Micheal Nash, Ph. D.'s avatar

Thanks but those observations are two decades old. Been retired that long. The primary on that project was too much influenced by Rosenberg to consider other options so my idea pretty well died on the vine

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