I finished listening to the first 6 episodes of the Bad Batch podcast last week. The series is by medical journalist Laura Beil. I think there will be a 7th episode that’s a Q&A.
I highly recommend listening to the series even if parts are wrenching at times like how much patients and families have been hurt. It’s important to know that reality and to hear directly from the real people who’ve been hurt.
The podcast focuses in large part on a supplier called Liveyon that sells non-FDA approved and in my view scientifically unproven umbilical cord “stem cell” products. I put “stem cell” in quotes because more broadly for perinatal products it’s not always clear if they have real living stem cells in them. Liveyon sells the product to care providers who then inject it into patients for many different conditions.
The firm’s owner, entrepreneur John Kosolcharoen (pictured from a video), as well as the patients and families harmed by a contaminated Liveyon product are the main real-life characters in this story. Bad Batch paints a stark picture of the unproven perinatal stem cell clinic industry and its suppliers.
You can read more about my sense of the podcast here, but in today’s post I want to focus on why I think Bad Batch could be bad news for perinatal stem cell clinics and suppliers overall.
For me the podcast showed in a convincing way just how much the unproven perinatal stem cell clinic universe is about making money and how little there is in the way of evidence of possible concrete benefit to patients. It was powerful how Beil juxtaposed Kosolcharoen having a newly purchased Rolls Royce in one part of the series with the moving stories of patients and families.
I was curious what Kosolcharoen thought of the podcast so I asked him for comment and here’s what he said:
“I think Laura did a thorough job investigating the story, but it’s very disappointing that after more than 6 hours of interviews and numerous texts, my deepest and sincerest apology to everyone who was affected was never aired, and my comments were cut up and selectively overlaid with a narrative that only shed negative light on an industry with great potential.”
Call me crazy, but going beyond an apology how about refunding the money that patients spent on all of the earlier questionable product from the outside vendor Genetech that was recalled and that in some cases made some patients so sick?
Now that would make quite a statement, but I don’t expect a voluntary refund.
Beil says toward the end of the podcast series that Liveyon if anything is doing better than ever now despite the news of the harmed patients. Wow. How can that be? I wonder how much settling all those patient lawsuits cost the firm? Did it have some kind of insurance coverage for these kinds of suits?
This growth of the firm with its now in-house “stem cell” product is occurring even as in my view it operates outside the bounds of normal clinical trial-based medicine and apparently is not much affected by the FDA oversight.
Without getting into arcane FDA regs, in my opinion it seems that Liveyon’s product (assuming it is indeed composed mostly of living umbilical cord cells) is more likely than not an unapproved drug. Indeed, the older version of the umbilical product from Genetech was described as such in the FDA warning letter to that firm.
So why hasn’t the agency done more here? It’s hard to know. Traditionally, you’d think a firm would have to prove their allogeneic stem cell product works and is safe to the FDA before selling it to doctors to inject into patients, right?
I hope the agency biologics regulators are listening to Bad Batch. It humanizes what’s at stake here.