“No shortcuts were taken”. Remember that. Because that’s what Surgeon General Jerome Adams told the Senate HELP Committee. Then they combined Phases 2 and 3.
I’m talking about the COVID-19 vaccine, of course. But do you remember Nuplazid? Or Uloric? Probably not.
Remember “Fast Track”, “Expedited Review”, “Accelerated Approval”, and “Priority Review” leading to drugs that were either ineffective, or worse: killed more people than they saved? Ah, yes. That you remember.
Do you remember how Pharma companies underwrite 2/3 of FDA’s budget? It’s a regulatory nightmare over there.
In Europe, things are getting just as bad.
According to “Seeking Alpha”, a site that promotes investments,
The European Medicines Agency ("EMA") says it will try to complete its review of Merck's COVID-19 antiviral pill molnupiravir in the "shortest possible timeframe."
The EMA acknowledged the need for additional guidance on COVID-19 treatments citing rising rates of infection and death.
Molnupiravir is currently under rolling review with the agency.
In the U.S., the FDA has scheduled an FDA advisory committee meeting to review of the drug for Nov. 30.
They cite Merck as the source of this information.
Please remember (or if you have not yet seen) that the data available on molnupiravir so far is restricted to a half-completed study and a press release - not peer-reviewed studies. Interim analysis. That’s it.
See my related Substack article published last month:
The design of one randomized clinical trial has been published. (Link). Whoopee.
Compared to the massive number of studies on other treatments (See, for example
When Merck’s marketing department thinks that “Fast Track”, “Expedited Review”, “Accelerated Approval”, and “Priority Review” are feathers in their cap, they are not quite reading the room right. Oh, that’s right. They are marketing to investors, not consumers.
PS I’m current on hold on Twitter for sharing a Substack article. So please do me a favor or ten? If you’re on Twitter, please share this article and all of my other recent articles on #PopularRationalism.
The word must get out.