FDA politics and ideology-driven decision-making seem more complex than ever. Much of this is due to RFK Jr. being atop HHS.
Before we dig into that, if you missed it, you might check out my predictions for the regenerative medicine field for the new year of 2026. It’s going to be a whirlwind of policy changes and conflicts too, including at the FDA. We’re already seeing signs of this.
FDA politics
Here’s the latest: FDA deletes warning on bogus autism therapies touted by RFK Jr.‘s allies, Ars Technica. What is it about Kennedy and autism? I don’t get it. What is the scientific or medical basis for such decisions?
I sometimes wonder what it’s like to be an FDA staffer these days, the people just trying to do their jobs based on data and help make a difference.
Stay tuned for a coming piece on a recent announcement about far more FDA flexibility on cell and gene therapy development.
Dead celebrity genomics, the continuing saga
The real da Vinci code: Scholars on a quixotic quest to identify Leonardo da Vinci’s DNA achieve a milestone, Science. Why do this? Because he was an amazing genius?
Dead celeb genomics without a clear purpose is mostly of little benefit and, at worst, can be ethically questionable.
More recommended reads
- Lineage Takes Delivery of Gene-edited Hypoimmune Cell Line Under Partnership With Factor Bioscience, PR. The company announced, “the receipt of a novel, induced pluripotent stem cell (iPSC) line containing hypoimmunity edits, from Factor Bioscience.” Cells that can fly under the immune system radar could have many applications. The potential tradeoff is that if something goes wrong post-transplant then it could go badly. How do you stop such cells if they’ve gone rogue other than a built-in suicide switch? Overall, Lineage Cell is an exciting company that I’ve followed for many years.
- “And so 2026 begins…with a resurrection of the myth that COVID vaccines cause “turbo cancers”, Science-Based Medicine.
- Basal cell of origin resolves neuroendocrine–tuft lineage plasticity in cancer, Nature. Tuft cells may be one of the most under-appreciated cell types. What are tuft cells? They are rare sensory cells in the gut and respiratory systems. In addition to being sensing and signaling cells, it’s become clear in the last few years that tuft cells can also serve a stem cell-like function in some tissues. Until I saw this new paper, I hadn’t thought about tuft cells or their programming playing a role in cancer. In this case, the tuft-like small cell lung cancer cells arise from some kind of precursor or stem cell that apparently is more like a basal cell than a tuft cell. It makes you wonder how many other kinds of cancers, including especially neuroendocrine tumors, may have tuft-like properties.
- Mitochondrial transfer from glia to neurons protects against peripheral neuropathy, Nature. It’s remarkable how often cells exchange mitochondria. Do they also shuffle other organelles? This should not be confused with the mitochondrial donation/transfer involved in trying to prevent mitochondrial diseases.
- China’s ‘Dr. Frankenstein’ Thinks Time Is on His Side, NYT. The saga of He Jiankui continues. How much should the news and sites like The Niche cover this guy? I don’t have the answer. He’s ex-wife Cathy Tie has her Manhattan Project here in the US too. One of the many complexities to He’s story is that he has financial backing for a big apartment in China and for research, but the backer remains a secret. To me that secrecy is a big problem.
- Bringing African ancestry into cellular neuroscience, The Transmitter. A team is developing a panel of iPS cells from African donors. Most iPS cells used in research are from donors of European ancestry so more diversity is going to be very helpful for the field and patients in the future.