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?
Category: Politics
Southeast Michigan is currently in the midst of a hepatitis A outbreak that started in August 2016. In Algonac, a small town in the Thumb region, the mayor decided to help a restaurant whose business suffered when one of its new staff members under training caught hepatitis A. Unfortunately, the form that help took was to host an antivaccine propaganda meeting.
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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.”
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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.
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There was a rumbling in the antivaccine underground a week ago about a recent ruling by the Vaccine Court compensating parents of a child who died of sudden infant death syndrome (SIDS). In a confused and scientifically highly flawed decision, the Special Master Thomas Gowen didn’t rule that vaccines cause SIDS, but did rule that they contributed to SIDS in this one case. Soon, the message will be that vaccines cause SIDS. They don’t. The Vaccine Court screwed up.
