My NECSS talk isn't done and something's got to give. So that means blogging will be sparse this week. Sorry about that.
Right-to-try is now the law of the land. Unfortunately, it's a law custom-made for the unethical who don't mind taking advantage of the terminally ill.
With the rise of quack stem cell clinics, there has been a rise of crowdfunding campaigns to assist patients in paying for expensive stem cell treatments of unproven efficacy. Unfortunately, as a recent study shows, these crowdfunding campaigns nearly always oversell efficacy and ignore potential risks of the treatments, while making powerful emotional appeals.
Last year, the FDA announced a regulatory framework for stem cell clinics, and hopes were raised that it would finally crack down on the hundreds of quack stem cell clinics in the US. Yesterday, the FDA dropped the hammer on two clinics, seeking injunctions in federal court to stop them. Is this the beginning of a real (and long overdue) crackdown on these clinics?
More and more, alternative medicine practitioners are offering unproven, almost certainly ineffective, and potentially dangerous stem cell therapies. How are they doing it?
Many are the stem cell clinics that hype their product as basically a magical cure for whatever ails you like so many used car salesmen deploying the hard sell. Florida seems to be the paradise where these poorly regulated clinics ply their unethical trade.
Last week, the FDA released final regulatory guidance regarding freestanding stem cell clinics. The new regulatory framework appears custom-made to allow the FDA to crack down on quack stem cell clinics. But will it?
Well, it’s done. Today, the Senate passed the 21st Century Cures Act, a bill designed to weaken the FDA and empower pharmaceutical companies, sending it to President Obama’s desk. There’s no way Obama won’t sign it, as it contains provisions funding his Precision Medicine Initiative, and he supported it all along. For all its flaws, I knew the bill’s passage was inevitable since after the election, when Senate Majority Leader Mitch McConnell stated that the bill was a priority. I knew it even more when the Senate linked the bill to the “Cancer Moonshot” initiative spearheaded by Vice President Joe …
I first became more interested in dubious stem cell clinics nearly two years ago, when I learned that hockey legend Gordie Howe was undergoing stem cell therapy in Mexico to treat his stroke. Being from Detroit, I imbibed the hockey madness of this town growing up, and know that Detroiters hold Gordie Howe in incredibly high esteem. Prominent in stories about Howe were two companies: Stemedica Cell Technologies, a San Diego company marketing stem cell treatments for all manner of ailments, and Novastem a partner company in Mexico that uses Stemedica products. Also prominent in the stories was Clínica Santa …
Stem cells are magic. Stem cells cure everything. They are the next big thing in medicine. That’s the narrative one frequently hears about stem cells in the press and courtesy of offshore stem cell clinics in places such as Italy and direct-to-consumer marketing of stem cells in the US. Of course, stem cells aren’t mystical and magical, although they are very promising as a treatment for some degenerative conditions. As promising as they are, though, they don’t cure everything. In fact, we don’t even know for sure that they cure anything because for the vast majority of conditions for which …