January 16, 2021

The Niche

Trusted stem cell blog & resources

Highlights of Science Writers DC Stem Cell Panel with FDA’s Peter Marks

I’m enjoying attending and speaking at the annual Science Writers 2018 meeting in D.C. where I spoke this morning on a panel about stem cells. The session was specifically on the Wild West of stem cells. You can follow the meeting events on Twitter with the #sciwri18 hashtag.

FDA Peter Marks, Science Writers 2018
FDA Peter Marks, Science Writers 2018

I had three wonderful fellow panelists, Marilynn Marchione of the AP, Terry Devitt of the University of Wisconsin, and Dr. Peter Marks, Head of CBER at the FDA (pictured). Marilynn and Terry ran the session.

The session was an interesting mix about the real promise of stem cells and also the astonishing extent of the unproven stem cell clinic industry in America today. I made the prediction that barring some radical change that in 2020 there will be 1000 stem cell clinics in the U.S.

Dr. Marks went through some of the key regulatory issues for stem cells in a way that was relatively easy to understand for the audience given how complex they can be.

Clinics tend to think of and/or portray their products as 361s (not drugs) even if they are in fact drugs requiring FDA premarket approval. Note that some clinics are using 361s such as unmodified bone marrow for orthopedic conditions, but most clinics overall are in my opinion using unapproved drug products.

In my talk I mentioned that the growing number of clinics selling birth-related “stem cells” (amniotic, placental and umbilical cord materials) seem to think (or at least argue) that they are not selling drug products requiring pre-market drug approval, but it seems many of them actually are non-compliant marketers of what are likely to be biological drugs. It was only days ago we all learned about the FDA recall of an umbilical cord product that might have been contaminated with E.coli. It’s not clear if that product contains living cells.

(Note that sometimes academia messes up too and a subset of those can get pretty ugly, as exemplified by the call by Harvard just now to retract more than 30 papers on cardiac stem cells. This stems from what might broadly be called the Anversa situation.)

Getting back to the Science Writers meeting, we got at least 10 great questions from the audience. One of my favorites was basically, “How do we know what is being injected into patients and if it is even really stem cells?” It fits with what I often tell patients: you often won’t know for sure what’s in the syringe they use to inject you. Scary stuff.

Dr. Marks was also asked by an audience member to comment on the extent of enforcement action pending on stem cell clinics. He mentioned the two suits against clinics firms. While he understandably couldn’t give more specifics on other fronts, I got the sense from what he said that more action is going on behind the scenes. He also mentioned how the FDA is focusing on the highest risk situations first. One example he cited of a type of very concerning “treatment” from a clinic was injection of a laboratory-amplified fat stem cell product into the spinal cord for migraines. Whoa.