#5SmartReads - August 27, 2020
On convalescent plasma, Kombucha Girl, and the second Civil War we're already in
Everyone who’s worked in life sciences has a FDA war story. But all of us deeply respect for the agency’s commitment of safety and efficacy of every drug and device they review for approval.
On the drug/therapy side, a big part of that is a placebo-controlled trial, which ensures that the therapy is actually effective, and not anecdotally effective.
Conducting a placebo study to evaluate convalescent plasma’s efficacy is not hard, nor would it take very long. And FDA Commissioner Hahn should know that, given his previous role of running MD Anderson.
The politicization of the FDA is deeply troubling to me, and I’m preparing for an October surprise of a COVID vaccine approval with a rushed study and sample analysis.
If the vaccine doesn’t work, it adds fuel to the fire of anti-vaxxers and further de-legitimizes the FDA’s important role in healthcare.
Keep reading with a 7-day free trial
Subscribe to hitha to keep reading this post and get 7 days of free access to the full post archives.