The perinatal stem cell clinic supplier Liveyon has had many issues recently including an FDA inspection that in my view didn’t go well and which I’ll return to in a minute. First, some background on the company and this troubled industry. E. coli and other pathogens ended up in some of the Liveyon product somehow […]
Dissecting Liveyon FDA inspection report & troubled perinatal stem cell industry Read More »
Institutional review boards or IRBs are some of the biggest enablers of risky, unproven stem cell clinics. We often see statements on stem cell clinic websites to the effect that they have approvals from IRBs so the clinic firms must think that patients like to see that. Why would specific IRBs approve for-profit “experiments” by
FDA needs to quickly act against IRBs enabling risky fat stem cell clinics Read More »
In a surprising development, the United States government (FDA and DOJ) and the stem cell clinic firm, US Stem Cell (USRM), Inc., that it has sued seeking a permanent injunction, have agreed on something! According to new court records on Pacer (see screenshot), they have both given up on mediation in the federal lawsuit. Further,
Clinic biz US Stem (USRM) may be kaput in matter of weeks or months Read More »
Maybe the announcement that Commissioner Scott Gottlieb will be leaving the FDA soon shouldn’t have caught us all off-guard, but it did. Gottlieb isn’t a perfect Commissioner, but he brought a sensible, open approach to running the FDA that was very refreshing. Amongst all the top leadership in the Trump administration, Scott Gottlieb stood out
Scott Gottlieb leaving FDA: possible reasons, impact on stem cell field, & more Read More »
A new Florida bill (Bill 65 of 2019) could make the practices of stem cell clinics a felony. At the same time it would open the door to patients receiving still experimental stem cells that have at least started the clinical trial process. What’s going on? A number of states have been stepping up action
New Florida bill mixes RTT spirit with turning unproven stem cell sales into a felony Read More »
The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a
FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely Read More »
Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many
Sizing Up Sizzling FDA Warning Letter to Fat Stem Cell Clinic Stemgenex Read More »
The stem cell clinic industry selling unapproved “therapies” is ubiquitous and yet somehow still growing it seems. Many of us are encountering more of them including via ads and the clinics are basically all over the place. What should someone do if they see a stem cell clinic that is particularly concerning? A lot of
To report a sketchy stem cell clinic, a list of simple, concrete things to do Read More »
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. I had three wonderful fellow panelists, Marilynn Marchione of
Highlights of Science Writers DC Stem Cell Panel with FDA’s Peter Marks Read More »
Last year I started seeing stem cells mentioned along with the opioid crisis in a particular way, but now recently I saw an entirely different pairing of stem cells with the opioid crisis. The first connection I saw was of a few for-profit, unproven clinic firms claiming that for pain sufferers it would be better
The opioid crisis, pain, stem cells, & FDA Read More »