New FDA Commissioner Marty Makary has brought on Dr. Tracy Beth Hoeg (or Høeg) as a special assistant.
Hoeg has had some controversial views on COVID. She has seemed skeptical of certain elements of vaccination, masking, and school closing.
What struck me is that she also has offered unproven cell therapies at a clinic here in Northern California. Recall that RFK Jr. seems very interested in de-regulating some types of unproven cell therapies.
With all of this in mind, could Hoeg be an FDA ally to unproven cell therapy clinics? It’s an interesting question but the answer is not simple.
Tracy Hoeg offers unproven cell therapy at clinic
The clinic where Hoeg provides care, Northern California Orthopaedic Associates, performs many traditional, proven orthopedic procedures. Hoeg does those as well. These are not controversial.
However, the website indicates that she also uses a variety of unproven regenerative medicine approaches. From her page on the clinic website:
“She will also discuss the evidence for/against injection treatments she offers, mostly done using ultrasound guidance, including dextrose prolotherapy, corticosteroid injections, hyaluronic acid injections, platelet rich plasma and bone marrow aspirate concentrate injections.”
Let’s focus on those last two that I emphasized. Platelet rich plasma (PRP) and bone marrow aspirate concentrate injections are not proven effective for orthopedic conditions. While these approaches have their fans, they are not standard of care. For that reason, insurance and Medicare generally do not cover them.
Hundreds of clinics across the U.S. offer these and other unproven regenerative approaches. The FDA has struggled to find its footing in this space.
Unmodified marrow and PRP are generally not biological drugs
Still, there hasn’t been much of an issue between the FDA and clinics marketing bone marrow aspirate and PRP. There are logical reasons for this.
First, most often these specific biologics are not defined as drugs. As a result, the agency doesn’t require drug-level data for their use. The agency also doesn’t require those marketing these products to first take difficult steps like getting INDs or a BLA.
Second, there just haven’t been many reported negative outcomes with these products. They seem mostly safe in the orthopedic sphere. Nothing is entirely safe, but I haven’t seen signs of repeated major negative outcomes with PRP or marrow cells specifically for orthopedic applications. I can’t really think of any off the top of my head.
A few clinics and doctors in the U.S. do appear to me to misuse bone marrow cells and may even be using the cells in ways where the cells may be unapproved drugs, but it’s relatively quite rare and not for orthopedic conditions.
Overall, since I’ve been doing The Niche since 2010, the FDA has been relatively hands-off on PRP and bone marrow cell products, unless they are grown in a lab.
Could Tracy Hoeg be an FDA ally to unproven clinics?
By contrast, adipose cell and birth-related cell clinics and suppliers have been in almost constant conflict with the FDA. Many patients have been harmed after getting injections of those products. When the FDA has talked about the stem cell clinic problem and “bad actors”, my sense is that it’s mainly referring to the perinatal and adipose clinic arenas.
Getting back to Hoeg, it’s hard to say whether as Makary’s aide she might take actions within the FDA that could help some unproven stem cell and regenerative medicine clinics.
I suppose she could advocate for the FDA to define even lab-grown bone marrow cells as non-drugs, but I don’t see any reason she’d do that. Perhaps she could work toward Medicare covering bone marrow aspirate and PRP?
It seems more likely that she was brought on because she already has co-authored papers with Makary, and has similar views as Makary on COVID policy. While most of her publications relate to COVID, she has also authored quite a bit of other research including on vision and marathon running that does not seem controversial.
I don’t see her as an obvious ally to the perinatal or adipose cell clinics or supplier firms.
Under Kennedy will the FDA favor perinatal cells?
For the most part, clinics using bone marrow and PRP injections also have not exactly been friends to clinics and suppliers selling perinatal and adipose cell products, and vice versa. There has even been some hostility between these groups.
While a few clinics straddle both areas and offer a wider range of regenerative cell offerings, most are in one camp or the other. So, in that sense, it could be a leap to imagine Hoeg being helpful to perinatal and adipose cell firms from within the FDA, especially given her regenerative medicine focus.
On the other hand, so far RFK Jr. seems most interested in perinatal cells so he could push things that way.
At the FDA Hoeg might just focus on vaccines and related policies, but we’ll see.
Also, the Kennedy family has experience using perinatal stem cells. For example, in 2018, one of the Kennedy family members was hit by a trolley in SF causing severe facial damage. The member was treated with WJ with a clinic in CA and experienced great results. A reason why RFK is a supporter.
Didn’t know that. Do you have a link?
While many in the mainstream have concerns about safety, and efficacy of biological agents in the practice of medicine, some concerns are justified, but in general these agents are safer than accepted surgery. There are 2 concerns with safety as it relates to PRP, cellular therapies and other biologicals. The first is infectious agents from a host or a preparation process in the office or in a lab. Infections are, however, a risk with any injection or surgical procedure. The main difference with biological agents is the source. If from a donor or prepared in non-certified laboratory there should be concern for potential contamination and spread of infection. The second issue is in regard to safe administration, this is no different than injection of other medical products such as steroids which have some catastrophic risks when injected into unsafe areas of the body. Thirdly, Injecting altered cellular products with potential for tumor-like growth are also a risk. Many of these biologicals have well accepted use in standard procedures such as wound care for amnion products and surgery for bone allografts. In summary to say that these are unsafe procedures is grossly mis-leading. They are, however, subject to misuse and abuse just like every other aspect of medicine and surgery.
In regard to effectiveness, I thank you for not saying that there is “no evidence”. However, there is more evidence of fair to high quality for PRP and BMAC than there are for many accepted and higher risk surgical procedures (e.g. spinal fusion). Not “proven”? What’s the bar for proof in medicine? well it is not a mathematical theorem or a physics experiment. Laboratory science is not the same as clinical science. Proof in medicine is the degree of confidence in the treatment in a well -defined clinical scenario. Like the rest of science, we only prove what doesn’t work and thereby, infer what does. Biologicals have been demonstrated to be superior to conservative care, and steroids in some specific orthopedic applications. Medicine cannot be chained to an unattainable standard of proof.
The number of practitioners embracing biological treatments such as PRP and BMAC as equal or superior to standard of care “steroid injections for orthopedic problems continues to grow for good reasons and sound clinical experience. One day it will be considered dangerous to repeatedly inject people repetitively with steroids and rare to perform spinal fusions.
I would not judge Ms. Hoeg too harshly on what is by no means a questionable practice. I have no other knowledge of her medical practice, but I am happy to differ any further judgement on what you present for now.
Respectfully,
David Hollifield MD
FAAPMR
FAAPM
It is easy to get cells from placentas, which are mostly fetal tissue, and they are discarded as medical waste, so yes, they would be cheap to produce. But they are just ordinary cells with no medically relevant properties. I would think that the use of fetal cells would seem creepy.
Have you figured out why they think that “perinatal” cells work? The belief is not based on evidence. There is plenty of evidence that they don’t work.
Hi Jeanne,
I’m not sure why some folks are so preoccupied with birth-related cells. The cells are sometimes portrayed as “young”, which is maybe close to meaningless. High profit margin for an off-the-shelf series of products?
The are portrayed as “young” because the express ESC markers such as OCT-4 and Nanog which bone marrow and adipose MSCs do not express. These markers have to do with greater telomerase function meaning that they are more stable genetically.
And as we try to bring the cost of stem cell therapy down so more people can benefit the perinatal tissues which are discarded are the best way to produce affordable and efficacious stem cell offerings.
Most perinatal cells do not express OCT4 and NANOG. It’s embryonic stem cells and iPS cells that have that. Those are pluripotent markers not found in cord MSCS, cord blood, amniotic and placental cells.
Right on. Paracrine effect works . That seems to be ignored by most reserachers and the FDA. Steven Bauer of FDA sent an article years ago that explained what and howit works but I can’t find it now. Probably deleted. Requirements for SC clinical trials get tougher and tougher to meet. It’s not for safety but because they can cure autoimmune and degenerative disease. Medicare pays for PRP unless it is for “regenerative medicine” . It should pay for Pain relief -long term.
This is simply wrong. This article might help you get up to speed on the use of Perinatal Stem Cells and Tissue products. https://pubmed.ncbi.nlm.nih.gov/33374593/
Perinatal stem cells have lots of advantages over bone marrow and adipose MSCs.
IWhile perinatal stem cells do offer certain advantages over bone marrow and adipose-derived mesenchymal stem cells (MSCs), in my opinion, MSCs from fat tissue, bone marrow, and perinatal sources function very similarly, with only minimal differences between them.