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.
All of the candidates being considered by President Trump for FDA Commissioner believe that the FDA is too strict in its standards for approving new drugs. In a commentary in Nature last week, two bioethicists argued that, at least in terms of preclinical data, the standard of evidence is actually too low. Which is correct?
I’ve seen it noted that our new President-Elect seems to be selecting his cabinet officers and directors of federal bureaucracies based on how much they oppose the mission of the department they are supposed to head. For instance, to head the Department of Health and Human Services, he picked an orthopedic surgeon who belongs to […]
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 […]