Posted on 03/19/2020 6:30:19 PM PDT by SeekAndFind
Edited on 03/19/2020 10:51:47 PM PDT by Jim Robinson. [history]
President Donald Trump is pushing the Food and Drug Administration to speed up approval of antiviral therapies that could combat the coronavirus, despite warnings that untested treatments could harm Americans infected with COVID-19.
In the short-term, Trump has directed the FDA to
(Excerpt) Read more at newsobserver.com ...
“[FDA commissioner] Hahn noted that the treatments would likely not be available for broad use for several months.”
I think they are needed now.
Easy to do when one has a job. HCQ works so be cautious during a pandemic? Yes he bothers me and I think Trump had had it with him. I hope.
An aside: I've always had problems with the FDA, but I grew up in the age when snake oil was a thing of the past. I believe government involvement in drugs got it start because of dangerous elixirs be sold to cure all ills. Then they got involved in food because of dangerous additives and packaging (lead cans). My stance on limited government is tied directly to pure competition, as espoused by economists, where consumers have perfect information on product and price. It was only recently you could get some idea how much drugs cost, and that information is not perfect. So the FDA is an epic fail.
Just require companies to tell me what's in their product and how much it costs. I can wade thru information to determine if it is right for me. And if I am on my death bed and there is no alternative to a inadequately tested drug, I'm will want to take the drug. What do I have to lose?
“FDA’s responsibility to the American people is to ensure products are safe and effective,” said Hahn.
Yes you have protected the American people by helping huge pharmaceutical company’s maintain and entrench their monopoly. The FDA needs to follow the Education dept and the EPA right out of the door, zero their funding and bid them A GOOD DAY SIR.
Hasn’t a drug all ready approved for treatment of another ailment been tested for safety and tolerance for human consumption? If so, it is safe and the only testing required would be for applicable dosage to treat the current ailment. There are lots of folks out there with the disease who would be and should be willing to act as human guinea pigs.
Personally I had a problem with restless leg syndrome which drove me crazy for years and no medicine seemed to work. While I was being treated for a completely difference ailment with a drug I had never taken before I noticed that the restless leg syndrome almost completely disappeared. Needless to say, I am still taking the new drug.
What was the new drug?
Yes. From what I understand, Hydroxychloroquine can be prescribed “off label” immediately. I think the FDA wants docs to report whenever they do so (I think).
Now I’m not sure Fauci was too happy about letting that sort of info slip.
Trump good. Hahn I don’t trust. The only flaw in the French hydroxychloroquine+azithromycin results was the sample size. That can be best resolved by repeating it on a larger sample. Our biggest need is for good news to end the panic. NYC has plenty of Covid cases and plenty of academic types to manage a trial. The CDC should be able to provide a trial design pronto. They should be starting a couple hundred New Yorkers as participants next week. If their results match the French ones they’ll have adequate preliminary statistical proof for anyone outside the swamp a week later with all actively treated patients viral loads going to zero, clinically improving and placebo treated patients still doing poorly. At which point the trial becomes unethical to continue and active treatment goes to all. All happening in the media’s front yard, ending the panic.
This is imperative, medically AND politically. The population density and medical infrastructure of NYC makes it ideal if there must be a trial. If anyone knows how to cut through red tape therein its Trump! Speed is essential. There may well prove to be to be a role for some of the other investigational drugs in the sickest patients or those with contraindications to this. But no other foreseeable active therapy is shovel ready, known to be usually safe, and scaleable to allow most test positive patients to self treat. Beyond this the only thing the FDA should be doing helping ramp up production of drugs and other needed supplies.
“an antiviral therapy used to treat malaria”
wrong! chloroquine is an antiparasitic treatment for malaria that might be useful as a novel antiviral therapy against COVID-19 ...
the average “reporter” is so ignorant of nearly everything that if they tried to give advice about how to hard boil eggs, people would end up scalding themselves and accidentally burning down their houses ...
“Hasn’t a drug all ready approved for treatment of another ailment been tested for safety and tolerance for human consumption? If so, it is safe and the only testing required would be for applicable dosage to treat the current ailment”
correct ... pretty much any drug already approved by the FDA can legally and ethically be prescribed for most any other medical purpose ... i suspect that most prescriptions are actually for off-label use because test trials for new drugs are designed to be extremely narrow in order to get results that can be approved by the FDA ... probably almost ALL antibiotic and antiviral prescriptions are off-label because the original trials were tested against only a single bug ...
“While I was being treated for a completely difference ailment with a drug I had never taken before I noticed that the restless leg syndrome almost completely disappeared. Needless to say, I am still taking the new drug. “
do you mind telling use what that drug is?
hydroxychloroquine and chloroquine are even used for long term chronic use.
No obvious reason not to prescribe for corona virus. The FDA is out to lunch on this one
Yes. Moreover hydroxychloroquine's safety record is old enough to be on Medicare. Chloroquine's is older than Bernie and Joe. And the other part of the French treatment, azithromycin, is old enough to run for President. We don't need safety testing. Arguably we might benefit from a trial running multiple dosage treatment arms.
Drug addiction became an issue in the decades after the Civil War. There were many thousands of soldiers who had been badly wounded in the war and they had lingering pain both real and phantom. Patent medicines containing opiates could be bought by anyone and you had no way of knowing exactly what was in them. They were big customers of that stuff and it often led to addiction.
Those were the very same decades when industrial scale food processing was invented. The ability to process and ship food all over the country was a new thing and some manufacturers were less than scrupulous about health and safety. Upton Sinclair’s “The Jungle” played on that and helped generate the pressure to create a government agency to deal with food.
In Teddy Roosevelt you had a Republican progressive and in 1906 the FDA was created.
Yep, exactly what I was writing about. Some regulation (choke) was need then. Although, give government a century and see what it goes into. Seems like the opiate problem never went away though.
I have taken Hydroxychloroquine twice a day since I was diagnosed with Lupus and Sjogren’s Syndrome in 2013. It is a very benign drug—zero side effects for me. It helps me fight infections with my nonexistent Immune System. It does affect (along with another injectible I take) the Kidneys & lower my resistance to TB so I have to take a TB/Kidney test twice a year. No issues so far
Since taking it, I have only gotten REALLY sick from a cold/Flu type one time. That was in 2015 and I was hospitalized for 4 days with the Flu.
It depends on what amount and how long I would think but it seems to be a good idea and option. Hope it works!
The FDA is the most corrupt agency in government. There is no valid reason to require doctors to call before giving one of these treatments. Their phony excuse is that they need to track what’s happening, as if such statistics are more important than people’s lives. Trump should fire the FDA director.
One of the flight controllers speaks up. “I was wondering what the Grumman guys think about this.”
The Grumman rep shrugs. “We can’t make any guarantees,” he says. “We designed the LM to land on the Moon, not fire the engine out there for course corrections.”
“Well,” replies Kranz, “Unfortunately we’re not landing on the Moon, are we?” The Grumman guy nods.
“I don’t care what anything was designed to do,” continues Kranz. “I care about what it can do. So let’s get to work.
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