For-profit stem cell clinics selling unproven and downright quacky stem cell therapies have proliferated over the last several years, with federal and state law seemingly powerless to stop them. Recently, the FDA and FTC have shown signs of acting to crack down on them. Now, the Medical Board of California is forming a task force to determine how to regulate physicians offering these unproven therapies. Will it matter?
Richard Jaffe was Dr. Stanislaw Burzynski's lawyer. For nearly two decades, Jaffe defended this cancer quack from the FDA, Texas Medical Board, and the government in the name of "health freedom" and even invented Burzynski's business model of having over 70 clinical trials open that allow him to treat any cancer patient he wants. More recently, he's been a defender of for-profit quack stem cell clinics. Last week, he shocked me by finding one stem cell clinic so quacky that he thinks the government should shut it down, even going so far as to use criminal prosecution if necessary. Basically, …
“Right-to-try” laws are a cruel sham that purport to allow terminally ill patients access to promising experimental drugs. In reality, they strip away many protections and leave vulnerable patients on their own. After four years and a number of toothless state laws, a federal version of “right-to-try” has passed Congress and is poised to become law. Once President Trump signs the bill this week, this federal version of “right-to-try” will leave terminally ill patients on their own and will likely be the first step in returning the FDA to its pre-thalidomide state, in which it only required evidence of safety, …
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.
Earlier this week, the FDA issued draft guidance that would, if adopted, allow it to regulate homeopathic remedies as drugs. Will 2018 be the year that the FDA finally stops deferring to homeopaths and regulating homeopathic remedies as drugs?
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?
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.