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?
It’s finally happened. A “right-to-try” bill is coming up for a vote in the House of Representatives. It’s been slightly modified from the version that passed the Senate last year to make it less patient-hostile, but it’s still the same cruel sham that right-to-try has always been.
Yesterday, I wrote about how right-to-try and an unethical offshore vaccine trial are part of free market fundamentalists’ attack on the FDA. Here’s another example, the “right to choose medicine.”
I’ve discussed so-called “right-to-try” laws, which promise to speed experimental drugs to terminally ill patients, but which in reality are about weakening and bypassing the FDA. Now über-Libertarian Peter Thiel is trying a new tactic to bypass the FDA by organizing an offshore clinical trial of a new herpes vaccine based on dubious science and not overseen by an IRB to protect patients. Both right-to-try and this trial are different fronts in the same fundamentalist free market war on FDA regulation.
Yesterday, I noted the passage of the 21st Century Cures Act, a Hobson’s choice of a bill for those of us who support increased biomedical research funding that basically said: You can have an increase in the NIH budget. You can have the Cancer Moonshot. You can have President Obama’s Precision Medicine Initiative and his […]