Up until now Utah hasn’t immediately come to mind as a hub for stem cell issues, but things are heating up there in 2019.
I was going to do a blog post here on The Niche last month about perinatal (birth-related) biologics and stem cell-related supply companies in Utah. Some of their customers appear to be unproven stem cell clinics so that concerned me. I even started writing a draft post many weekends ago.
However, it’s taken some time to try to square away what’s going on and I’ve been emailing with the companies to get their perspectives. I’ve also been working on a grant (of course). The end result is that my original timeline went out the window and it’s already mid-August. So what’s going on?
Lowe blogs & gets lawyer letter
A chemist and blogger named Derek Lowe posting over at Science Translational Medicine (STM) at a blog called In The Pipeline has already written bluntly about his views on the Utah situation. After that it wasn’t long before Lowe tells us that he got a strongly-worded letter from a law firm, Snell & Wilmer. Their letter seems to argue that his Utah blog post was defamatory. The firm represents one of the two major (apparently competing) Utah biologics supplier firms that Lowe mentioned. It’s called Utah Cord Bank.
Note that the other major Utah perinatal stem cell-related biologics supplier mentioned by Lowe, Predictive Technology, is a publicly-traded firm ($PRED). Earlier this summer short sellers made allegations including some related to stem cells about PRED’s practices. When I contacted PRED by email, they indicated that they had responded briefly in a general way to the short seller claims here and that they dispute the claims. To my knowledge, the allegations remain unconfirmed. My interest here is mainly in stem cells so an important question is whether specific products of PRED or more specifically its subsidiary Predictive Biotech even contain stem cells? Maybe some do and some don’t?
Now back to that letter that Lowe received.
How did this start and what’s going on in Utah?
I think the story in part begins with Caroline Chen’s ProPublica/New Yorker scathing piece back in May on the perinatal biologics and stem cell arena. I noted that the word “Utah” was mentioned 15 times in the article largely related to Utah Cord Bank. Chen’s article seems in part to be what led to Lowe’s blog post over at STM. His blog post was entitled provocatively, “The bottom of the stem cell barrel” and apparently placed in his blog post category of “Snake Oil.”
In a newer 2nd Utah-related post, Lowe informs us that he got that aforementioned letter from Snell & Wilmer representing Utah Cord Bank. Lowe posted the entire letter and included his own lengthy, sometimes pointed responses to it. You can see a screenshot of the top of the letter that I’ve included here.
Do you consider this letter to be a SLAPP threat to Lowe? My opinion is that this seems like a SLAPP threat. SLAPPs are strategic lawsuits against public participation. SLAPP threats are unfortunately not that uncommon for critics of the unproven stem cell clinic and supplier sphere.
Notably, Utah has an anti-SLAPP law, but it’s considered weak getting a D grade, while in contrast here in California we have what’s considered maybe the best anti-SLAPP law in the country.
In California, both those filing SLAPP lawsuits and even their attorneys can be penalized by courts depending on the outcome of the case.
A complex situation
I can’t do full justice to all of this Utah situation with Lowe and the companies now here in this post on The Niche so I suggest you head over and do some reading on Lowe’s blog on STM and see the companies’ statements too, but suffice it to say that Lowe is generally not backing down. Read the comments on his pieces too. There’s some interesting back and forth. I’d be curious of your opinions about all of this so come back and post comments here too.
Keep in mind that although the two Utah companies have some similarities in my view, we should also consider them individually. For example, the short sellers’ allegations about PRED are not only unproven, but also don’t have any obvious connection to Utah Cord Bank, and Chen’s article about Utah Cord Bank may or may not have much relevance to PRED.
Note that I had a productive email exchange with Utah Cord Bank. They disputed key points of Chen’s article and emphasized their track record of FDA compliance. I hope to include more of our email exchange in a second post on the situation in Utah.
The bigger perinatal biologics picture
In terms of the perinatal stem cell and biologics arena overall in the US, many serious questions and concerns remain. Another perinatal firm, Liveyon, which appears to be a foreign LLC located here in California, has also been much in the news and patients have ended up hospitalized due to E. coli and other bacteria ending up in the product prior to injection into patients.
One general, even bigger question (assuming products are not adulterated) relating to the unproven clinic arena overall is the extent to which any stem cell-related biologics supplier should have responsibility for what its customers (such as stem cell clinics) do with the product?
I’m also still trying to revisit and sort out the FDA position on the use of living, allogeneic perinatal stem cells (assuming there are living stem cells in the syringe or IV bag in any particular situation) in patients who are not relatives of the donor. It seems to me that in many cases, in part depending on how the products are used and marketed, that they would probably be drugs requiring premarket approval by the clinics from the FDA. In part my view on this issue is shaped by a recent FDA letter to a clinic doctor.
How much should suppliers be required to do in the way of due diligence in determining whether their clinic customers are using a product in an FDA-compliant manner? Should they fire customers who are clinics and/or are marketing the supplier’s products in over the top ways? Probably non-FDA compliant ways?
Maybe things will be clearer on the perinatal front across the US and in particular in Utah by the end of the year, but we’ll see.