November 27, 2020

The Niche

Knoepfler lab stem cell blog

As 2 FDA stem cell clinic suits slowly unfold, more action needed now

For me there was a sense of “finally” when just under 3 months ago the FDA filed suits via the DOJ against 2 stem cell clinic firms, U.S. Stem Cell (and its affiliate U.S. Stem Cell Clinic, collectively referred to here as USRM) and California Stem Cell Treatment Center/Cell Surgical Network (collectively referred to here as CSN) seeking permanent injunctions. However, since the filings in May not much of anything has changed on these fronts and it appears that the FDA has taken no action against other apparent non-compliant clinics more broadly. In my opinion there’s a simple but troubling equation that applies here: the longer this limbo period persists, inevitably the more patients will get hurt and/or lose their hard-earned money.

Salvaor Dali, The Persistence of Memory; waiting game
Salvador Dali, The Persistence of Memory

As far as I know, USRM and CSN are continuing to sell what I see as unproven and unapproved stem cells to patients, and that could continue for a very long time. Already there have been delays granted by the court. The two court cases themselves are going to be slow, which is not unexpected. The USA vs. Regenerative Sciences case took a couple of years.

If these cases could take up to two years too and that could be easily anticipated, why didn’t the FDA go for temporary injunctions (a possibility discussed in my Q&A with Patti Zettler here)? Did they believe the temporary injunction requests would be denied?

The agency sent a clear message in May, but that message is already fading somewhat now today on August 1. The more time that goes by with no additional action, the less likely it is that non-compliant clinics will even think much about this.

It’s not just about risks for patients and the stem cell field, but also for the FDA itself in terms of its credibility if it’s seen as tolerating large-scale, non-compliant use of unapproved stem cell-based drugs in the context of (A) known harms from it and (B) the FDA’s very vocal pledge to do much more on what it called “bad actors” in this stem cell clinic arena.

Plus, there are more unapproved stem cell clinics opening every week too.

Beyond adipose stem cell and bone marrow-based clinics, amniotic and other birth material-related clinics are exploding in numbers with potentially non-compliant products often being transplanted by non-physicians. Talk about a dangerous combination.

While of course not all of the hundreds of stem cell clinics are non-compliant and some that are non-compliant may be relatively much less risky than others, in my view there are loads of specific, very problematic firms out there that warrant serious action by the agency and I believe these are known to the agency.

FDA, you need to do considerably more on the stem cell clinic problem and do it quickly. If there are wheels turning behind the scenes as I suspect there are, spin them much faster. The stakes are high and could include preventable patient serious injuries and even deaths, as have occurred already as documented comprehensively by a new paper (with my UC Davis colleague Gerhard Bauer as first author) just out today.

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