RFK Jr. might be the biggest peptides fan of all. Or it could be the compounding pharmacy industry or Joe Rogan. For a few years, compounders were profiting from marketing the most popular of these unproven peptide drugs (what I call “pop peptides”). The FDA put a halt to that in 2023. The agency at […]
Vinay Prasad is out at the FDA after less than three months. It may be the shortest tenure as CBER Director in FDA history. This is an ominous sign for the agency, but probably not just for the reasons you might first think. Vinay Prasad’s departure and gaps in FDA leadership Prasad had three key roles.
Why sudden Vinay Prasad departure from FDA is about more than Sarepta missteps Read More »
It’s Halloween and one of the scariest things out there is a wild tweet from RFK Jr on stem cells and the FDA. Why worry what Kennedy thinks about such topics? Trump has indicated that Kennedy will have some major healthcare role in his second term should he be re-elected. The last thing we need
RFK Jr on stem cells & his wacky war on the FDA Read More »
When I first started this blog back in 2010 the most contentious issue on the more political side of our field was federal funding for embryonic stem cell research. It was something you couldn’t take for granted. Some history on embryonic stem cell funding in the US There were times back then when funding of
Is embryonic stem cell research a target after Roe? Read More »
The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of
Politics & FDA OK of 2 stem cell clinic COVID-19 efforts Read More »
Since Donald Trump was elected our new president the scientific community has tried to adjust to this new reality or at least absorb the shock that many felt. Responses from scientists range from “not my president” to “maybe it won’t be so bad”. Mostly it seems people are stressed about an uncertain future for science
Ways for scientists to deal with Trump election Read More »
The REGROW Act would drastically weaken FDA regulation of experimental stem cell therapies. I’ve criticized it in numerous posts (see those here) for its radical ideas that would put patients and the stem cell field at risk. I’m not the only one concerned about it as both ARM and ISSCR oppose it too. Now 10 top patient advocacy
Ten patient groups oppose REGROW Act that would gut stem cell oversight Read More »
How would Donald Trump, if elected president, impact American science? Would Trump on Science be a good thing, bad thing or somewhere in between? Would he “reject” the NIH budget? Might he even personally reject some grants, “Your R01 is fired” just for fun? And, yes, I know I’m biased. Take our poll. Can we
Trump on Science: Poll & His Words Read More »
There is considerable interest in FDA regulatory reform here in the U.S. for stem cell therapies. The goal is to get new treatments to patients faster, but is there a way to do that without sacrificing proven safety and efficacy? You need convincing data on both safety and efficacy or speed becomes dangerous. Bipartisan Policy Center
Cons Outweigh Potential Pros to BPC Plan on Stem Cells & FDA Read More »
The White House seems to be getting more active on genetics in the last six months. It’s refreshing to see them actually talking about real, important science. My feeling has been that up until now they’ve been giving too little attention to science so even if you may disagree with some aspects of what they
White House Gets Going on Genetics Read More »