Weekly reads: Prasad exit & replacement, FDA on Leucovorin, Mexico’s stem cell clinic industry

By / 2 Comments / / FDA, Prasad exit / Weekly Reads
FDA Cell & Gene Therapy Roundtable, Prasad Exit
Vinay Prasad, the outgoing CBER Director (right), with Commissioner Marty Makary, at a cell and gene therapy roundtable last year.

Vinay Prasad is leaving the FDA again in a few weeks. As CBER Director, Prasad was all over the place on how he handled oversight of biologics. He and Commissioner Marty Makary promised flexibility from the agency, but so far we’ve mostly just seen chaos. Some like The WSJ felt that Prasad’s decisions were overly strict and inflexible. However, what got me was the chaos and potential role of politics in biologics decisions. Some of that stems from Makary and RFK Jr. and won’t change with Prasad’s exit.

Prasad exit (again) & possible replacements

The biggest question now is who will lead CBER after Prasad’s exit. The reasons behind him leaving again could help predict his replacement. This piece from Matt Herper is of interest in that regard: 5 lessons from Vinay Prasad’s turbulent tenure at the FDA,  STAT. 

I believe that Makary is likely to go for someone he already knows. Perhaps even a Hopkins colleague or someone he has published papers with in the past. He won’t want someone controversial politically within this administration. Predictions? FDA insider Vijay Kumar? Move Tracy Beth Høeg over from CDER? 

Recommended Reads

Nevada Regulators Fine Peptide Providers at Anti-Aging Festival Where Two Women Became Critically Ill, ProPublica. I wrote before about this incident where peptides made two women sick. It seems like the FDA should be looking carefully into this situation, but under RFK Jr., they may be more inclined to loosen oversight of risky, unproven peptides.

Eagles star undergoes stem-cell treatment amid injury issues, Penn Live. I’m posting about this because “stem cell treatment” seems to have been normalized for pro athletes, when it shouldn’t be. Eagles player Landon Dickerson reportedly engaged in some stem cell tourism: “Dickerson confirmed on social media that he was in Colombia for a “health reset week” at bioXcellerator, a self-described “world leader in stem cell therapy.” This is not a proven therapy. I also don’t see this clinic as a “world leader” in stem cells. I wish this kind of article would do just even a little more by noting what the FDA says about stem cell therapies and clinics.
 
 

 

Brain Tumor Research Fundraising

Last week I asked readers for help in supporting our brain tumor research. A few mentioned having trouble finding the link (you click the colorful image of stem cells to go to the fundraising page). Here’s the direct UC Davis donation link for my lab for convenience.

Inside Mexico's stem cell clinic industry

Inside Mexico’s stem-cell industry, Nature. This piece from Gemma Conroy is one of the first really deep dives into the stem cell clinic industry in Mexico. One of the trends that we’ve seen for more than a dozen years is Americans owning clinic south of the border in part to avoid FDA oversight. In 2023, a man died right after getting an unproven cell therapy in Mexico.

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2 thoughts on “Weekly reads: Prasad exit & replacement, FDA on Leucovorin, Mexico’s stem cell clinic industry”

  1. Gracie Boyter

    What if any studies have been done on GHK- cu in regards to bone marrow cancers (MDS and Myelofibrosis)

    Reply

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