RFK isn’t even confirmed as HHS Secretary and things are going south already with an NIH freeze.
What do I mean?
NIH freeze could do lasting damage to biomedical research
The Trump Administration has frozen many NIH processes including meetings such as study sections that evaluate grant proposals.
No study sections means almost no new grants. How long will this freeze last?
The order apparently came down from someone in the current HHS leadership.
Science covers how the NIH freeze is likely to lead to serious problems. Already there’s some element of chaos. This goes beyond any kind of reasonable transitional pause on some NIH processes. Regardless of one’s politics, this freeze is unnecessary as well as harmful to science and medicine.
I haven’t heard anything yet about what’s in store for the FDA, but it seems in a precarious position.
WaPo piece on RFK
Here is another piece on RFK. Alternative medicine fans see RFK Jr. as a hero. The field’s skeptics worry, WaPo.
I’ve written before about worries about Kennedy and stem cells. I don’t know why he hasn’t had a confirmation hearing yet to be HHS Secretary. This WaPo piece does a solid job of tackling the topic of Kennedy and stem cells, but it’s unclear why it focuses so much on “biohacker” Dave Asprey. It even includes four giant pics of him, which seems way over the top.
From the piece:
“Asprey is no fan of the FDA. In 2020, the agency warned a company Asprey ran at the time, Bulletproof 360, about its website’s marketing of supplements purporting to reverse aging and block production of inflammatory cells and proteins. The site also pointed to a study that claimed a sugar molecule in one product helped heart failure patients breathe easier. The agency said some of the company’s products were not “generally recognized as safe and effective” for the uses advertised….Asked about the FDA’s letter, Asprey said he is no longer associated with Bulletproof 360.”
Dave Asprey has also promoted unproven stem cell therapies, stem cell boosts, and exosomes. Is Asprey somehow a buddy of Kennedy? I did find an Instagram post of the two together where Asprey says they had dinner. This was back in March of 2024. There was another of the two together from 2023.
More recommended reads
- What a $20,000 Longevity Clinic Really Buys You, NYT. I’m surprised there’s no mention of “stem cells” here as many of these longevity clinics also offer some kind of supposed cell infusions.
- On a happier front: Early-stage trial finds stem cell therapy for retinitis pigmentosa is safe, UC Davis Health. I’m not involved in this research here at UC Davis, but it sounds encouraging as a Phase I trial. Here’s the research paper: Phase I Study of Intravitreal Injection of Autologous CD34+ Stem Cells from Bone Marrow in Eyes with Vision Loss from Retinitis Pigmentosa, Ophthalmol Sci. My colleagues Susanna Park and Jan Nolta are the first and last authors, respectively, along with other faculty here. In terms of possible mechanisms, if there is benefit as trial work continues, the paper writes, “CD34+ cells home into damaged tissue and promote tissue repair via paracrine mechanism.”
- OpenAI has created an AI model for longevity science, MIT Tech Review. This is about using AI to enhance cellular reprogramming to make iPS cells. The study seems interesting to me as a stem cell researcher who works with iPS cells. I’m just not sure how much long-term impact this will have. So far we only have a press release on this, which has some interesting but very preliminary data, and no paper. Note that reprogramming to make iPS cells is already quite efficient in many cases. It’s often good enough even to reprogram cells from very old people.
- Dysregulation of REST and its target genes impacts the fate of neural progenitor cells in down syndrome, Sci Rep.
FDA warnings
- FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products, The Dallas Morning News. This is about Frontier Biologics, which recently received an FDA warning letter. Writing in regard to part of the letter, “Frontier Biologics chief scientist Gene Elliott pushed back against that characterization, telling The Dallas Morning News that the FDA’s approach is too “white or black.” He argued the agency is painting the company as a bad actor for what he described as mostly mild and documentation-related violations…He also argued the FDA should not have categorized Frontier Biologics as a “stem cell” company, although the term “stem cell” does not appear in the publicly available version of the warning letter. Elliott argued there should be another regulatory category created that differentiates “biologics” more distinctly from “drugs.” One of the regulatory challenges in this broad area is that products can be both biologics and drugs. Which transitions nicely to the next recent warning below.
- Warning letter to XO Biologix, LLC, FDA. This letter went to David P. Janice and relates to the firm’s MaviX amniotic product. As is common with these kinds of perinatal product warnings, it noted that the biological product is a drug and that there are cGMP concerns.
Blast from the past
FDA warning to Amniotic Therapies, LLC: impact on stem cell clinics? Way back in 2016 the FDA was already focusing extra resources on perinatal products.
I do not understand why the NIH/CSR halted study sections. This has NOTHING to do with communication with the public. If fact, it’s confidential. Overcompliance is hurting us.
@Diane, I believe HHS told NIH it had to stop all study sections.
What is the evidence for this?
I’m not sure if there are additional memos that were issued but this HHS one seems to be the main one that has led to the halt: https://www.insidehighered.com/sites/default/files/2025-01/actinghhssecretarymemoaction2212025.pdf
Thanks for sharing this document. While I am just one person with my own opinion, this document supports my opinion that HHS is over-interpreting the call for an “Immediate Pause on Issuing Documents and Public Communications.” There is NOTHING in this document that says that study sections should be cancelled – NOTHING. Each of the 5 actions refers to communications with the public (announcements, regulation guidance, and posts on social media, websites, press releases, and communication using listservs.
We don’t have all the info so things are vague.