This is on COVID and vaccines and politics, but it needs to be discussed, IMO, so here we go...
So the plot keeps thickening on the political side of the vaccine effort, which is unfortunate. If the politicians would just stfu, we'd all be in much better shape and confidence in getting a vaccine would be growing, instead of plummeting, as per a recent Pew Research poll, which showed that now only 51% of Americans are likely to get a COVID vaccine down from 72% in May. Having said that, IMO, the lion's share of the blame is on Trump for consistently appearing as though he is willing to disregard vaccine safeguards in order to launch a vaccine by the election, via an Emergency Use Authorization. However, the rhetoric on the dem's side on this one has been a bit over-the-top, IMO, too and has added to the confusion/loss of confidence - but the reason I place a lot more blame on Trump is the dems wouldn't be saying a thing, if Trump wasn't poking the bear.
https://www.pewresearch.org/science...divided-over-whether-to-get-covid-19-vaccine/
Anyway, Trump has ratcheted up his rhetoric on this in the past day or so, saying he disagrees with the FDA tightening requirements for an EUA for a vaccine (as they've been discussing) and having Azar invoke the legal provisions of the EUA afforded to him by the law in order to disregard the possible objections of the scientists at the FDA. The link below provides an excellent summary of the situation (from Endpoints, the well-respected biotech blog/newsletter). This is kind of an update on the thread below.
https://endpts.com/azar-falls-in-li...es-reinforcing-a-dark-signal-sent-to-the-fda/
https://rutgers.forums.rivals.com/threads/ot-daily-covid-thread-9-23.201383/post-4706709
And here's where it gets interesting, legally. Dr. Henry Miller wrote a really detailed, insightful article on this last week and he was the first one I saw point out the issues in the USC Code on EUAs, which predate any of this. There exists a loophole in the Federal LAw (U.S. Code, Title 21, Chapter 9, subsection c), that could be used unilaterally by Hahn’s boss, the HHS Secretary, Alex Azar, a political appointee and lawyer (not a scientist). The relevant section of the law, “Authorization for medical products for use in emergencies,” specifies that:
The Secretary may issue an authorization under this section with respect to the emergency use of a product only if, after consultation with the Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention… the Secretary concludes (1) that an agent referred to in a declaration under subsection (b) can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that (A) the product may be effective in diagnosing, treating, or preventing (i) such disease or condition.”
The article notes that the Secretary is "only required to consult with,
but not obtain agreement from, the three subordinates specified in the law." In a normally functioning government, there should be no way possible for the Secretary of HHS, who is not a scientist, to overrule the heads of NIH and CDC (it's also odd that the head of the FDA is not part of that advice group), if their scientific advice is that an EUA is not safe to pursue and all of these folks are on record saying that politics will play no role in any EUA for any vaccine, but I certainly share the concern that there is a path to ignore such advice.
https://geneticliteracyproject.org/...ctober-surprise-could-be-an-october-disaster/
This is a time when Americans and our scientists and politicians should all be on the same page, as we're on the precipice of an historic breakthrough in vaccine technology, assuming one or more of these vaccines is safe and effective (which most expect), as nobody thought this could be done in under a year, let alone in under 24 months when this all started - and assuming we achieve this, this will likely be Trump's biggest accomplishment of his presidency, as he was a huge driving force behind Warp Speed. We should be celebrating this likely accomplishment, not arguing over how it might be deployed prematurely.