How bad could things get with RFK Jr. changing the FDA’s approach to unproven stem cells? I’ve been asking myself this for months since Kennedy’s post that mentioned stem cells on X.
New developments suggest things will get much worse.
Up until about a week or two ago, my feeling has been that things could get substantially riskier as Kennedy’s actions related to the FDA likely help clinics selling such cells. More than one thousand stem cell clinics across the U.S. sell a variety of such stem cells and similar biologics. Things have often gone wrong so there are many risks here.
Then last week, the ouster of CBER director Peter Marks raised the likelihood even higher of major problems ahead on cell therapies. But what went on behind the scenes with Marks being forced out?
Now The Wall Street Journal has a piece from Marks’ perspective that gives even more reasons for concern. It just reported that RFK Jr. likely intends to weaken regulations on unproven stem cells.
Marks on RFK Jr. plan on stem cells
Peter Marks talked to the WSJ about RFK Jr.’s plans on vaccines and other biologics including stem cells. He called Kennedy’s short tenure so far, “Very scary.” The piece begins:
“The top vaccine regulator (Marks) ousted by Robert F. Kennedy Jr. said the health secretary’s team has sought nonexistent data to justify antivaccine narratives and pushed to water down regulation of unproven stem-cell treatments.”
The article also reports:
“Marks said Kennedy’s team was also interested in weakening regulation of unproven stem-cell treatments, which clinics and websites sell for diseases ranging from Alzheimer’s to arthritis. He met with top HHS officials to discuss the issue, he said, and offered to meet them halfway by proposing a new set of regulations that would keep rules vigorous for risky treatments but more lenient for less risky therapies.”
As I had suspected, Marks was willing to bend somewhat on CBER oversight of certain kinds of lower-risk stem cells but not break with a data-centric approach. Apparently, that wasn’t sufficient for Kennedy.
The danger here
The piece goes on: “What they are trying to do is potentially dangerous,” he (Marks) said. “These stem cells, if they are made improperly, they can harm people.”
Many of the unproven clinics and cell suppliers don’t go wrong just with the making of the cells but also in how they inject them, market them, and more.
What kind of risks are we talking about?
People have lost their vision after getting fat cells injected into their eyes. Contaminated umbilical cord cells gave dozens of people infections.
Some patients have even died after getting unproven cells, but it’s hard to prove whether the cells were responsible.
Almost all the negative events have been related to unproven adipose and perinatal cells. The new HHS Secretary seems most interested in the latter.
The fact that Kennedy held a regenerative medicine roundtable in D.C. that was attended by a stem cell clinic doc but not Marks is another recent sign of potential major changes in the FDA’s approach to stem cells.
What’s next for the FDA on stem cells?
The FDA may soon take steps to dramatically loosen regulations on some cells. This could manifest first with perinatal cell injections that until now have been classified as drugs.
If that does happen, there’s little doubt that more people are going to get hurt. Also, I expect an effort to sway Medicare and insurance companies to cover some unproven cell injections.
One of the saddest things about the current situation is that just a few months ago I was writing about how the FDA and CBER had taken major steps forward in overseeing unproven stem cell clinics. Now the agency seems to be heading in the opposite direction. Reading between the lines, it’s now almost akin instead to “how can we help some of the unproven clinics?”
Quite sad seeing that Dr. Marks was willing to meet halfway and it was shot down.
Even sadder is if the floodgates open, people get hurt, public fear ensues and stem cell therapy is pushed back another 5 years. That’s a bad day for everyone involved
It seems like the legit stem cell research field is going to be damaged no matter how this plays out.
I have to add to this that patients have no idea what is being injected in their bodies. They have to take the word of the peddlers of this stuff that the material consists of stem cells. Given the nature of these businesses and their marketing, there is little reason for any patient to think they are telling the truth.
@David, That’s another good point. Often it seems like there are no live cells in the syringe, especially in perinatal preps, and if there are live cells, they may not be stem cells. Adipose preps like SVF often may be almost entirely fibroblasts and similar non-stem cells. The perinatal products have a higher risk of contamination too. If firms properly sterilize them, they often probably kill any living cells in there, but if they don’t, there may be E. coli, etc. Some patients are very aware of the risks and other considerations, but many others just trust almost implicitly that when they are told “stem cells” it’s real and safe, etc.
The pending (2025) Florida Senate Bill 1768 authored by Jay Trumbull is going to be another blow to federal regulation of stem cells as drugs. He has proposed NO significant regulations on physicians using stem cells in orthopedics in Florida. No regulation is a horrible idea in my humble opinion!
Link here:
https://floridapolitics.com/archives/724072-jay-trumbull-james-buchanan-file-bills-to-make-stem-cell-therapy-more-available/
Thanks for mentioning that Don. I’ve been meaning to write something about the FL bill. It’s odd in some ways including how they’ve written it to exclude marrow and adipose cells. Makes me think of the Utah law on placental cells. The big push seems to be for perinatal cells and RFK Jr. may be onboard on that.