A variety of states have stepped up to address unproven stem cell clinics within their borders and the latest is Vermont. According to the VTDigger and writer Anne Wallace Allen, the Vermont Medical Society is planning a number of steps to address this situation. For example, at their encouragement a Vermont lawmaker will introduce legislation to regulate stem cell clinics in the state: “Vermont lawmakers will be asked in the coming year to consider regulating stem cell clinics like Vitality Healthcare in Williston and …Read More
Florida stem cells
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 related to stem cells and specifically stem cell clinics. The steps on unproven clinics range from bills, some of which have become law such as here in California and …Read More
There’s the batmobile for Batman, right, but what about a stem-cell-mobile? Every so often someone sends me some wild new stem cell clinic thing that they’ve seen that is both real and almost unbelievable at the same time. The latest is a mobile stem cell “clinic” business called RegenMed of Florida, which is what I’m calling the “stem-cell-mobile”. There isn’t much info on this company on the web including on their homepage, but I did find their Facebook page and a picture of what …Read More
There’s a lot going on in Florida with non-FDA approved stem cell offerings even just related to stem cells for vision problems alone, but while US Stem Cell has drawn the most attention related to patient allegations of severe vision loss in Florida after fat stem cell injections in eyes, another group I’ll loosely call the “SCOTS Trial” has also been injecting investigational stem cells (in this case from bone marrow) into patients’ eyes and some patients have made allegations of harm there too in …Read More
California broke new ground with our stem cell law that went into effect on January 1. It requires stem cell clinic firms to post notices informing patients of important information such as the fact that their offerings are non-FDA approved. At this point, 4+ months into the enforcement period, I’m not sure if anyone has looked into compliance. Anyone know? If you run a stem cell clinic, have you posted notices? Is you are a patient in California who has been to such a …Read More
If the FDA can “go big” to issue 40 warning letters to the e-cig industry as it just yesterday, why has it recently only issued 1 or fewer warning letters per year to the unproven, for-profit stem cell clinic industry in the U.S., which includes hundreds of businesses blatantly operating in what seems to be a clearly non-compliant fashion? FDA Commissioner Scott Gottlieb has used very strong language to describe stem cell clinics including the phrase “bad actors”, but so far we haven’t seen much …Read More
The last few years for the publicly-traded stem cell clinic biz, US Stem Cell, Inc., which goes by the ticker $USRM, have seemed like a rollercoaster to me as an observer. I can see four main areas of news that to me make the future seem uncertain for this firm. First, the US Stem was linked to the alleged blinding of some of its customers in 2016, faced two lawsuits (now settled) on that front, and now has to deal with a third lawsuit. Second, probably in part …Read More
There’s some also encouraging action at the state level on direct-to-consumer stem cell clinics operating without FDA approval including most recently in Washington State. Last year here in California we passed a bill into law that (1) requires stem cell clinics selling non-FDA approved therapies to post notices for patients and (2) instructs the state medical board to keep track of the situation. Democratic Senator and Dr. Ed Hernandez was the sponsor. More recently Republican lawmakers in the Florida State legislature sponsored a bill aiming …Read More
Did you hear the one about the deep state FDA, big pharma stem cell conspiracy theory? This is the phony idea that the FDA, big pharma, and, heck, sometimes even certain academics (who could that be?) are plotting together as some kind of biomedical secret society or “deep state” to block promising stem cell therapies from reaching patients. It is one of the more persistent stem cell myths out there. Unfortunately, the stem cell arena is more prone these days to this kind of fake news. …Read More
Florida is a hot mess on the for-profit stem cell clinic front. My own state of California isn’t much better and actually has a great number of clinics, but more problems are coming to light in Florida, at least at this point. Now WLRN reports that a legislator in Florida has proposed a new bill to try to address some of the issues with the clinics. Many clinics in Florida are making money from vulnerable patients and in some cases have apparently caused them harm, including claimed …Read More