“There are already docs recommending booster doses, and there are sufferers who’ve gone on the market, by hook or criminal, and have obtained boosters already,” mentioned William Schaffner, an infectious illnesses professor at Vanderbilt College Faculty of Medication. “The typical affected person and the common physician assume a advice with a capital R has already been made. Washington received out forward of its skis somewhat bit.”
If you’re regulating new expertise for diagnostics, it’s laborious to stability velocity and security.
Final week, prosecutors and protection attorneys made opening statements within the felony trial of Elizabeth Holmes, the previous CEO of Theranos, who’s accused of defrauding buyers and sufferers with false guarantees of low cost, speedy blood exams. The following day, the Biden administration introduced a plan to buy 280 million low cost, speedy COVID-19 exams—an motion for which some lawmakers have been advocating for greater than a yr. The serendipity of those two occasions exposes an unresolved rigidity in well being care: How will we stability the dangers of disruptive innovation with the mortal prices of administrative inertia?
Theranos and COVID-19 testing are each cautionary tales of failed medical oversight, however the morals flip from one case to the opposite. Every addresses, in its method, how a lot management the FDA ought