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With COVID-19 surging, Trump wants science to move far faster. It can’t.

#11
C C Offline
(Mar 21, 2020 07:50 PM)Zinjanthropos Wrote: [...] Most companies, even foreign, use FDA as their benchmark for approval. Fact is other countries have their own testing agencies and can approve drugs the FDA does not. [...]


And vice versa.

"Between 2011 and 2015, the FDA reviewed new drug applications more than 60 days faster on average than did the European Medicines Agency. Europe has also rejected drugs for which the FDA accelerated approval, such as Folotyn, which treats a rare form of blood cancer. " --FDA increasingly approves drugs without conclusive proof they work
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#12
Yazata Offline
(Mar 21, 2020 06:47 PM)Zinjanthropos Wrote: I don't follow politics and if the Americans elected an idiot then it's their problem. Still I can't help but see Trump on tv once in awhile. I figure he's smarter than any of the plugs who are trying to get him out of office.

I agree.

Quote:I've invested in drug companies in the past and I can tell you for a fact that the FDA approval process takes years for most everything new, from drugs, devices & procedures, primarily to avoid liability because there's always people who have an adverse affect or die. Covering the bases. But there is a fly in the ointment.

There's tens of millions of people more or less trapped in their homes, while most of the economy shuts down around them. There's the prospect of massive loss of life, potentially hundreds of thousands or even millions. It's an emergency situation.

So we can't wait for the old creaky 'peacetime' bureaucratic system to convince itself that a particular drug is "proven" effective (they use an idiosyncratic meaning of 'prove', where it doesn't mean logical proof, but merely passing tests that satisfy them). That approval will take more than a year, even if they claim that they are expediting things. It just takes time to set up and conduct large clinical studies.

Quote:Do I think it could be speeded up? Absolutely...

...So if gov't can push Big Pharma aside during a national crisis then do it and worry about who gets the credit later. It's pharmaceutical triage.... people will still die but you hope the numbers are fewer. Kind of like dropping an A-bomb to avoid excess casualties, it's war.


I like what President Trump is proposing. Ask the FDA to conduct all the studies that it wants to conduct for as long as it feels it needs, before it endorses chloroquine as an effective treatment for coronavirus. But allow physicians to prescribe chloroquine to their coronavirus patients in the meantime, based on the growing number of anecdotal reports of successes coming from other countries. (Anecdotal reports that may or may not turn out to be true.) As President Trump says, what does a terminally ill patient have to lose?
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#13
Zinjanthropos Offline
Quote:So we can't wait for the old creaky 'peacetime' bureaucratic system to convince itself that a particular drug is "proven" (they use an idiosyncratic meaning of 'prove', where it doesn't mean logical proof, but merely passing tests that satisfy them). That approval will take more than a year, even if they claim that they are expediting things. It just takes time to conduct large studies.


Agree


Quote:And vice versa.
 

That's my point. Let's get everyone involved and take a run at this thing.
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#14
stryder Offline
this might be the paper that has got chloroquine suggested to be used in the fight against it:
https://www.sciencedirect.com/science/ar...7920300881

Incidentally if you don't want to wait round for an expensive drug you can always pick up a bottle of tonic water, although I couldn't guarantee it will have any major effect... although Chloroquine (a derivative of Quinine) supposedly aids in retarding replication of Covid19 cells.
Don't go silly with it though, drinking 30 gallons of tonic water would likely be toxic in it's own right.
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#15
Yazata Offline
(Mar 21, 2020 10:16 PM)stryder Wrote: this might be the paper that has got chloroquine suggested to be used in the fight against it:
https://www.sciencedirect.com/science/ar...7920300881

Thanks for posting that. I'll have to study it.

Quote:Incidentally if you don't want to wait round for an expensive drug you can always pick up a bottle of tonic water, although I couldn't guarantee it will have any major effect... although Chloroquine (a derivative of Quinine) supposedly aids in retarding replication of Covid19 cells. 
Don't go silly with it though, drinking 30 gallons of tonic water would likely be toxic in it's own right.

Aren't we supposed to mix gin with the tonic?

According to Wikipedia, gin and tonics originated with the British army in India. They knew that quinine had some effectiveness against malaria. So the army was encouraged to drink quinine water. But early tonic water (the name gives it away) was so bitter that they started mixing things with it to make it more palatable. I guess that they decided gin worked best. (Works for me.)

The connection with malaria is interesting and might conceivably be important.

This is all just speculation, but a lot has been made about coronavirus' seeming slow rate of spread into the tropics. There have been speculations that it doesn't do well in warm temperatures along with predictions that its spread might slow in the northern hemisphere summer. But... coronavirus is doing well in Singapore, which is certifiably tropical. So the thought crossed my mind that it might not be the warm temperatures that inhibit coronavirus, but that it might not do well where malaria is endemic and many people have some malaria immunity. Which would probably explain Singapore's vulnerability, since malaria has presumably been stamped out there.

Of course malaria and covid-19 are caused by very different agents. Malaria is caused by a small parasitic eukaryotic protozooan, while coronavirus is a virus. But perhaps for some unknown biochemical reason (unknown to me anyway) coronavirus and the malaria parasite have similar vulnerabilities.
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#16
C C Offline
Fauci says he can’t stop Trump from talking at briefings
https://apnews.com/6e97c258920e5fd3b5a93d831927bd3d

RELEASE: Dr. Anthony Fauci says he can’t jump in front of the microphone to stop President Donald Trump from speaking at daily White House briefings on the coronavirus outbreak. The nation’s top infectious disease expert tells Science magazine in an interview that Trump listens “even though we disagree on some things.”

“He goes his own way. He has his own style,” Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases, said in the telephone interview with the magazine on Sunday. “But on substantive issues, he does listen to what I say.”

Trump complained at a recent briefing that China should have told the world about the virus much earlier. The new coronavirus originated in China. Fauci says he told the “appropriate people” after Trump made the comment that “it doesn’t comport, because two or three months earlier would have been September.” The coronavirus emerged in central China in December.

Fauci said that Trump’s aides may caution him against repeating the statement but that if the president chooses to say it again, “I can’t jump in front of the microphone and push him down.”

Trump and Fauci sparred politely but publicly last week over whether a malaria drug would work to treat people with the coronavirus disease. Asked about being present when things are said that he disagrees with, Fauci said: “I don’t disagree in the substance. It is expressed in a way that I would not express it, because it could lead to some misunderstanding about what the facts are about a given subject.”

Twitter notices when Fauci isn’t present for the briefings.

On Friday, the doctor put a hand over his face when Trump injected a conspiracy theory into the proceeding by referring to the State Department as the “Deep State Department.” Fauci’s brief hand movement and facial expression became an internet meme. Asked if he’d been criticized for it, Fauci said “no comment.”

For most people, the new coronavirus causes only mild or moderate symptoms, such as fever and cough. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia. The vast majority of people recover from the new virus.

According to the World Health Organization, people with mild illness recover in about two weeks, while those with more severe illness may take three to six weeks to recover.
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