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 »
Attorney Richard Jaffe, who has been an advocate for clinics to have the right to sell and patient to buy unproven therapies such as the stem cells sold by clinics and unproven cancer therapies, just did a kind of shocking u-turn on a specific point. Jaffe and I have very different philosophical views of the
Attorney Jaffe, fan of less oversight, still clobbers Florida stem cell clinic firm Read More »
When you get an FDA warning letter (like if you are a non-compliant stem cell clinic) you generally aren’t feeling too well after reading it, but now there’s an extra thing to worry about according to the FDA. A fake FDA warning letter. Apparently 3-dozen or more of these fake FDA warning letters sparked complains
Fake FDA warning letter scam Read More »
I didn’t know until recently that the FDA has a blacklist, which is called the “FDA Debarment List”. You can check it out here. Should one or more particularly egregious unproven stem cell clinic operators should be on the list given their risk-taking with patients in the name of profit? There aren’t any on there
A real FDA blacklist: what is it, who’s on it, & should some stem cell clinics be? Read More »
Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits?
When the fat stem cells hit the fire, will clinics sued by FDA opt to stop soon? Read More »
At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it
Helpful Zettler insights from Q&A on FDA suits against stem cell clinics Read More »