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The P&R Plague Thread (Covid-19)


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3 minutes ago, ColoradoHusk said:

My 7th grade daughter is still wearing a mask at school.  We don't pressure her either way, and she's triple vaxxed.  It's just her preference.

 

Maybe I need to pwn her and yell at her to take the mask off!!!

Haha!  Do it!

Teach her what FREEDOM is!

  • Haha 1
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1 hour ago, knapplc said:

How much money changed hands before that decision?

 

 

 

The ‘very, very bad look' of remdesivir, the first FDA-approved COVID-19 drug

 

October was a good month for Gilead Sciences, the giant manufacturer of antivirals headquartered in Foster City, California. On 8 October, the company inked an agreement to supply the European Union with its drug remdesivir as a treatment for COVID-19—a deal potentially worth more than $1 billion. Two weeks later, on 22 October, the U.S. Food and Drug Administration (FDA) approved remdesivir for use against the pandemic coronavirus SARS-CoV-2 in the United States—the first drug to receive that status. The EU and U.S. decisions pave the way for Gilead's drug into two major markets, both with soaring COVID-19 cases.

 

But both decisions baffled scientists who have closely watched the clinical trials of remdesivir unfold over the past 6 months—and who have many questions about remdesivir's worth. At best, one large, well-designed study found remdesivir modestly reduced the time to recover from COVID-19 in hospitalized patients with severe illness. A few smaller studies found no impact of treatment on the disease whatsoever. Then, on 15 October—in this month's decidedly unfavorable news for Gilead—the fourth and largest controlled study delivered what some believed was a coup de grâce: The World Health Organization's (WHO's) Solidarity trial showed that remdesivir does not reduce mortality or the time COVID-19 patients take to recover.

 

Science has learned that both FDA's decision and the EU deal came about under unusual circumstances that gave the company important advantages. FDA never consulted a group of outside experts that it has at the ready to weigh in on complicated antiviral drug issues. That group, the Antimicrobial Drugs Advisory Committee (AMDAC), mixes infectious disease clinicians with biostatisticians, pharmacists, and a consumer representative to review all available data on experimental treatments and make recommendations to FDA about drug approvals—yet it has not convened once during the pandemic.

 

The European Union, meanwhile, decided to settle on the remdesivir pricing exactly 1 week before the disappointing Solidarity trial results came out. It was unaware of those results, although Gilead, having donated remdesivir to the trial, was informed of the data on 23 September and knew the trial was a bust.

 

"This is a very, very bad look for the FDA, and the dealings between Gilead and EU make it another layer of badness," says Eric Topol, a cardiologist at the Scripps Research Translational Institute who objected to remdesivir's FDA approval.

Wonder what has changed in the 18 months since that came out?

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3 hours ago, ColoradoHusk said:

My 7th grade daughter is still wearing a mask at school.  We don't pressure her either way, and she's triple vaxxed.  It's just her preference.

 

Maybe I need to pwn her and yell at her to take the mask off!!!

My kids still wear them too,  all vaxed.  My wife is kind of a crazy Covid lady though…

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