Right now the FDA has a big fat stem cell conundrum on its hands. The agency is faced with a tough dilemma as how to deal with fat (adipose) stem cell products and the large number of businesses who sell them. Are fat/adipose stem cells a drug or not? If yes, what does the FDA do about the hundreds of clinics currently marketing them without approval? If not, then how does the agency reconcile that with its past statements and even words this year under …Read More
Reposted from my book, Stem Cells: An Insider’s Guide.
The Texas Legislature is considering three risky bills that would give free rein to stem cell clinics to profit big time off of patients by selling unproven and unapproved “stem cell treatments” that have little if any science behind them. I call one of these bills “Right to Profit” for clinics, which if these became law could get millions from vulnerable patients and potentially block patient rights. Some of these bills including HB 810 reportedly got a boost from emotional, teary-eyed testimony from Texas Representative Drew Springer …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 front, endangering patients. Such a development would strongly contrast to all the great, cutting edge stem cell research going on in labs across that state. Somehow this major development …Read More
You can stop taking a pill or an injection treatment, but you can’t stop or retract stem cell treatments if there’s a bad side effect. Unlike other kinds of medicines, once stem cells have been transplanted into patients, if something goes wrong you cannot stop the ‘treatment’. There’s no retraction possible because transplanted stem cells spread in the body and potentially integrate. One of the striking things in the commercial stem cell arena in 2016 was the emergence of patient lawsuits against stem cell …Read More
The FDA is holding a 2-day stem cell meeting starting tomorrow and it promises to be a really big deal. What’s the scoop on this meeting and the attendees? Who is likely to say what? If the deregulatory proponents get their way, could we have stem cell clinics like Starbucks popping up in even more neighborhoods? I have a satirical cartoon from some time ago I drew imagining such a future.