On one level a reasonable argument can be made for letting terminally ill patients have a right to try experimental as yet unproven therapies, but in the real world Right-To-Try laws have many downsides. On the whole, they are likely to be negative for patients as a group. Raising the stakes is a push for […]
Will Right-To-Try Morph into Right-To-Profit for Stem Cell Clinics? Read More »
The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already
Six questions as FDA takes new shot at stem cell clinics Read More »
The Calexit and Texit state secession campaigns for California and Texas to leave the union, which are linked to Russian President Putin, are never going to be successful. However, if some Texas lawmakers and stem cell clinics there have their way, Texas would take a big step away from the rest of us on the stem cell
3 Dangerous Texas Bills Would Boost Stem Cell Clinics Read More »
Are stem cell clinics going to somehow get the FDA to approve their stem cell interventions? To get recognized as legit? It seems they are trying now more than ever. Remember the REGROW Act that would have greatly reduced regulations on investigational stem cells and then how the 21st Century Cures Act passed with some
American stem cell clinics put thousands of patients at risk each year through hawking expensive, unproven and unapproved medical interventions, and now Dr. Oz is reportedly taking them on in a new show set to air tomorrow. Those running the clinics have affixed the buzz phrase “stem cells” onto a whole range of stuff ranging
Dr. Oz Explosive Exposé on Stem Cell Clinics Airs Tomorrow Read More »
Some amniotic stem cell clinics seem to be trying to have their cake and eat it too. Generally the amniotic stem cell clinics market their products as “stem cells” and the implication is that living stem cells are used to effectively treat many medical conditions. I have not seen it mentioned that what some of
Wanted both dead & alive: amniotic stem cell clinics sell zombie cells? Read More »
Dear FDA, The stem cell clinic clock is ticking on you. Before the Trump administration rolls in to possibly tie your hands on many important areas of oversight including stem cell clinics, you should take bold action now. Your CBER branch has been preternaturally quiet on taking actual regulatory actions on stem cell clinics for
Open letter to FDA: take action now on stem cell clinics before Trump Read More »
Patients contact me all the time these days asking about American stem cell clinics. The most common question boils down to “should I get a treatment at clinic X and what things should I think about in trying to make this decision?” I recommend checking out my stem cell treatment guide for patients. In addition,
The car shopping analogy for evaluating stem cell clinics Read More »
I’ll be on NPR’s @hereandnow w/Robin Young in about 40 minutes talking stem cell clinics. #Stemcell clinics thrive in US despite lack of @US_FDA regs. Is it #SnakeOil? @Pknoepfler thinks so. https://t.co/NxJ5z3IVGw @hereandnow — Karyn Miller-Medzon (@KBMM) September 1, 2016 Listen in if you have the chance and the segment will also be archived on
I’m on NPR’s Here & Now Talking Stem Cell Clinics in ~40 minutes Read More »
The FDA’s CBER branch recently issued a warning letter to Amniotic Therapies, LLC. The warning letter pertains to both AlphaGEMS-related products that are used by a number of stem cell clinics as well as problems determined at the manufacturing facility. I went to the Amniotic Therapies website, but perhaps not coincidentally it is down, which
FDA warning to Amniotic Therapies, LLC: impact on stem cell clinics? Read More »