But the idea that the FDA will approve it for new uses -- without even being asked -- seems a very slippery slope. I will thus (perhaps in jaundiced fashion) note that Fresenius Kabi, Hikma, Sagent, and GSK each make a version of it -- and we should all watch for donations from these companies, to any Trump controlled PAC or campaign coffer. Or even a crypto- purchase -- from / into one of his family run sh!t-coins empires in the making. Or to Truth Social. Dammit.
I hate that I now am forced to think that way -- but seriously. . . consider the billions to be made if all of MAGA-America is going to demonize pregnant women for taking what is undoubtedly safe Tylenol -- and start feeding their autistic kids a diet of. . . Leucovorin. Here's The New York Times' very sober piece on it all -- and a bit:
“. . .Mr. President, you told us to do what’s medically right — to go bold and not worry about the corporations and the lobbyists,” Dr. Marty Makary, the F.D.A. commissioner, said on Monday. “So that’s what we’re here doing today.”
Dr. Makary announced the sudden change during the president’s briefing on autism, which Mr. Trump repeatedly used to directly link Tylenol, the brand-name version of acetaminophen, to the disorder -- a connection that is still unproven.
The F.D.A. was more cautious in a letter to doctors. . . the agency [said] that the association remained an “area of scientific debate.” The health officials promised to fund more studies to explore a potential connection. Kenvue, the maker of Tylenol, has said the drug does not cause autism and is safe to use as directed. . . .
नमस्ते
4 comments:
The leucovorin announcement seems poorly thought out. Leucovorin is used as a rescue for high dose methotrexate, an anticancer drug used for leukemia, lymphoma, and osteocarcinoma. Two of which primarily affect children. I have treated children with high dose methotrexate and leucovorin and have seen truly horrific deaths from methotrexate due to drug interactions. My fear is that a run on leucovorin could prevent the use of high dose methotrexate causing children to die from treatable cancers.
Regardless of whether it's a good decision or not. It was poorly executed without apparent consideration for the consequences to others by not having an increased supply ready.
As for the science, I am unfamiliar with it, but I found this blurb from the Autism Science Foundation. https://autismsciencefoundation.org/leucovorin/
Thank you so much, Anon.
Agree 100% -- and the whole reason Congress wrote the FD&C Act the way they did (as you clearly know). . . was to be sure that rigorous studies are done, and independently reviewed, before a drug is used for a new indication. In sum, to prevent a repeat of thalidomide being given to pregnant women -- for "nerves":
https://www.sciencemuseum.org.uk/objects-and-stories/medicine/thalidomide
What Tangerine 2.0 has done. . . is to essentially thwart 75 years of solid procedural policy. His move likely violates the law. Y A W N.
It may well be "safe" -- to give autistic kids the drug, but there isn't any rigorous, peer reviewed independent evidence that it is. . . effective.
So your "stock-outs" theory -- thus harming cancer patients -- is. . . now likely.
Damn. Thank you -- do stop back, and. . . as ever, Namaste.
RFK Jr's cousin Ted Kennedy Jr had osteosarcoma. It's typically very treatable with kids typically having to have a limb cut off. However, they then often have to undergo 1 or more surgeries to scope metastases out of the lungs. With repeated metastases, high dose methotrexate is needed. I wonder how his family will view the risk of stock outs.
Geez, Anon. — I had no idea.
This is all. . . Just surreal.
Demonizing pregnant women, and telling them to “get tougher” (re Tylenol — Tangerine’s precise words!). . . .
Just. . . Damn.
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