Tag: Balaji Srinivasan

Categories
Bioethics Biology Clinical trials Medicine Politics

Shame! Another front in the libertarian war on the FDA: Rational Vaccines’ unethical offshore herpes vaccine clinical trial

The shame this unethical clinical trial deserves cannot be overemphasized.

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.

Categories
Clinical trials Medicine Politics Science Skepticism/critical thinking

What if, rather than being too stringent about drug approval, the FDA is not being stringent enough?

FDA

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?

Categories
Medicine Politics Skepticism/critical thinking

Next up on the Trump crazy train: A man who thinks that a “Yelp for drugs” will do a better job than the FDA

Be afraid. Be very afraid of this man.

One of the most important, if not the most important, officials in the federal government responsible for applying science-based medicine to the regulation of medicine is the FDA Commissioner. As you might imagine, particularly after his having met with antivaccinationists like Andrew Wakefield and Robert F. Kennedy, Jr., I am concerned, and I think I […]