FDA Must Approve
Hydroxychloroquine Now
American Thinker,
by
Andrew Longman
Original Article
Posted By: Magnante,
3/22/2020 8:29:18 AM
You are being lied to about the drugs that heal COVID19.
America's FDA, and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, are dragging their feet on approving a drug that provides very strong positive effect on COVID19. (snip) Fauci is taking the position that he and the US government should not approve Hydroxychloroquine because it might not be safe and might not be effective, based on his smear of high-quality science as mere anecdote.
Reply 1 - Posted by:
felixcat 3/22/2020 8:34:54 AM (No. 353914)
Fauci is a Hillary loving Democrat bureaucrat who is 79 years old and should have retired a decade ago. If President Trump keeps relying on his "advice" and that of the FDA - we are all screwed, the economy ruined and no second term for Trump. So next year when there is another strain of some flu or virus coming from China, we all locked down again? Europe survived the Black Death and this is not the plague.
32 people like this.
The question I have for Dr. Anthony Fauci is...So what? So what if it's only anecdotal evidence. The stuff is well-known, any side effects well-documented, and the Government has whipped people into a frenzy that is evidenced by such as the run on TP, the hoarding of canned goods, and the closing or severe curtailment of businesses...despite few cases of actual COVID-19. ("Infections" does not mean one is sick. See Tom Hanks or Prince Albert for how the numbers are misleading.) The use of hydroxychloroquine should simply and immediately be allowed if not approved for COVID-19 prevention and/or treatment.
45 people like this.
Reply 3 - Posted by:
franq 3/22/2020 8:39:43 AM (No. 353918)
Dr. Faustus.
14 people like this.
Reply 4 - Posted by:
IowaDad 3/22/2020 8:48:33 AM (No. 353927)
Not true! The evidence that plaquenil and chloroquine benefit patients is no more than suggestive. We can complete several blinded randomized trial in about a week. Doctors are perfectly free to prescribe these drugs without FDA approval in the interim if they chose. There are thousands of analogues of these drugs that may be far more effective. Let’s wait for proof before making idiots of ourselves!
9 people like this.
Reply 5 - Posted by:
ROLFNader 3/22/2020 8:48:52 AM (No. 353928)
Watching this guy's reaction yesterday to President Trump's use of the phrase " Deep State Department" is all I needed to know about his agenda . Looks and sounds like a cross between Robert Reich and Professor Irwin Cory. Knowing that he admires Hillary Clinton is all we need to know about this 'man'.
41 people like this.
Reply 6 - Posted by:
Jethro bo 3/22/2020 8:50:59 AM (No. 353930)
Yes, I remember when retuxamimb was the greatest cure for advanced breast cancer ever. So much so, that it was pushed as standard of care treatmemt. Congress made it Federal law that insurance companies had to pay for it in breast cancer treatment (still a law). ANd when randomize studies came out, guess what, it killed more women and than those not taking it. The FDA even reversed its approval for breast cancer. For generations medicine has tried to find that one miricle drug that will blunt the sepsis mechanism and lead to improved survivial. Some efforts did no good at all. Some made things worse and killed more people than the disease itself. The experience in NOLA with this combination of drugs for Covid-Insane hasn't lived up to the hype from this one anecdotal study in France. If one wants to be part of an experiemental protocol with this combination, fine, go for it. But to say this is a standard of cae without any knowledge of its effectiveness, side effects, and proven benefits is cavalier.
11 people like this.
Reply 7 - Posted by:
ARKfamily 3/22/2020 8:52:44 AM (No. 353933)
I want this message to go to Dr. Anthony Fauci. I have been calling him Antonio so I apologize. Americans are resilient and we aren't going collapse and fall like you, the media, Democrats, and Never Trumpers want us to. Our foundation is in God and he is bigger than any of you.
We know what you are trying to do. Approve it. You had no problem during the H1N1 and Ebola outbreaks. Read Job again in the Bible. We all know what we can be during prosperous times but we really find out what we are made of during trouble times. President Trump and Vice President Pence are showing us their leadership.
My foundation is in God not your gods.
30 people like this.
Reply 8 - Posted by:
sw penn 3/22/2020 9:00:41 AM (No. 353936)
Safety First!
What is "safe"?
Stay in your house to be "safe"...
Stay in your house long enough,
you starve to death.
What is "safe"?
Is safety the most important thing in the universe?
Did hundred of thousand of Americans die over 200 years
so you could be "safe"?
Narcissism is a dangerous thing.
Never far away, and easily manipulated
by those with hidden motives.
"After years of Safety First indoctrination, and a front row seat to it's unintended consequences, “Safety Third,” became a slightly subversive way for my crew and I to remind each other that our safety was in fact, our responsibility, and that no amount of compliance could ever keep us out of danger. Safety, I argued, was not a value to be “ranked,” but rather, a state of mind to be maintained. Thus, “Safety Third” became an hour-long special that stirred up a great deal of conversation around personal responsibility, risk equilibrium, and the unintended consequences of ranking Safety above everything else. "
Read it all:
https://www.facebook.com/TheRealMikeRowe/posts/3119126308097491
Safety Third!
Thanks Mike.
16 people like this.
Reply 9 - Posted by:
LadyHen 3/22/2020 9:00:43 AM (No. 353937)
At this point, what could it hurt? It's a known drug with know side effects.
God save us from petty, small minded, partisan bureaucrats!!!!
42 people like this.
Reply 10 - Posted by:
davew 3/22/2020 9:04:10 AM (No. 353942)
Here is what I think the FDA and Fauci would respond to this argument. The Gautret study was non-randomized and open label. That means that the researchers picked which patients would get the real treatment and which would get the control. History is full of examples of clinical researchers introducing intentional or inadvertent bias in this process to get the results they want especially when the stakes are as high as preventing a pandemic.
Although I doubt this happened and the results are reproducible in a true RCT study, it is a matter of principle to scientists that you must prove something using the gold standard of a randomized placebo controlled trial with a statistically significant number of trial subjects before you can call a therapy safe and effective. In the mean time, given the good safety profile of hydroxychloroquine with azithromycin it should be approved by doctors off label under the compassionate use provisions of the law.
15 people like this.
Reply 11 - Posted by:
DCGIRL 3/22/2020 9:09:39 AM (No. 353950)
Okay, hydroxychloroquine is safe for consumption. So, what would be the worse thing that could happen if given to coronavirus patients? Really, nothing. The only thing that could really happen is put a end to Dr. Fauci 15 minutes of fame. I say it's time to put this man in a closet again where NO ONE can get access to him.
45 people like this.
Reply 12 - Posted by:
lakerman1 3/22/2020 9:15:09 AM (No. 353957)
we all should take a collective deep breath here.
Dr. Fauci is a lab rat, whose job it is to drag his feet, looking for substantial scientific evidence before giving blanket approval for a particular form of treatment.
It would be possible for two separate drugs, each safe by itself, to be dangerous in combination. that happened with a diet drug, phentermine,back in the 1980s,and an anti-depression drug. when combined, the product was dangerous.
there is evidence available by identifying those who are taking hydroxochloroquine, like Mrs. Lakerman, for rheumatoid arthritis, and examining
their incidence and recovery from Kung Flu. computerization would allow this, along with a change in privacy laws. and the focus could be on NYC pharmacies.
As for the Chinese physicians and their treatment modes, it is difficult to trust them, given their government meddling with them.
14 people like this.
Reply 13 - Posted by:
Bazi 3/22/2020 9:24:07 AM (No. 353968)
Looked up side effects :"Taking hydroxychloroquine long-term or at high doses may cause irreversible damage to the retina of your eye. Stop taking this medicine and call your doctor at once if you have trouble focusing, if you see light streaks or flashes in your vision, or if you notice any swelling or color changes in your eyes." No hydroxychloroquine for me. I already have Macular Degeneration with visual symptoms.
3 people like this.
Reply 14 - Posted by:
Strike3 3/22/2020 9:27:51 AM (No. 353972)
The FDA has ruled the pharmaceutical industry with an iron fist for years to the point where they dictate how computer software is written and who has access to data. The end result is exhorbitant profits, enough to spread around to companies like Merck, Phizer, J&J, etc., hospitals, doctors, pharmacies, insurance companies and of course, the tax man. It's hard to break free of a bureaucracy like that because it is in their blood. They claim the profits are justified but just look at their corporate headquarters, gymnasiums, on-site child care, perfectly landscaped grounds, office furnishings, corporate helicopters, CEOs pulling in double-digit millions in salary and perks and you can see nothing but money.
6 people like this.
Reply 15 - Posted by:
SamNJ 3/22/2020 9:30:05 AM (No. 353973)
If this little weasel were fired now, the fakenews media and democRATS would explode with false indignation and he'd be appearing on the alphabet media day and night, attacking the President, ala Comey, Brennan and Clapper; better to keep him on the team and gently sideline him for the duration.
17 people like this.
Reply 16 - Posted by:
bpl40 3/22/2020 9:33:11 AM (No. 353980)
PDT should take a second opinion. But then move in at Trump speed.
17 people like this.
Reply 17 - Posted by:
Ditto1958 3/22/2020 10:03:47 AM (No. 354011)
The anti-malarial drugs in question are already approved, and are in fact “old.” There is plenty of data out there on them. Doctors should be able to use them “off label” safely. Let’s see if they really do work.
15 people like this.
Reply 18 - Posted by:
coyote 3/22/2020 10:10:59 AM (No. 354017)
The medical orthodoxy has played this game for over a century.
8 people like this.
Reply 19 - Posted by:
DVC 3/22/2020 10:14:31 AM (No. 354029)
No question this information is NOT anecdotal, it is a small study, without some of the normal scientific requirements, which limit it's certainty. I think Trump recently got a new law passed called "right to try" experimental drugs. Why can't this be under that system?
I'll play devil's advocate here for a bit. The normal standard is a double blind (neither the doc or the patient know which drug is which), random test. This test being referred to was "open-label, non random", so the docs and patients knew that they were getting a new treatment. There is extremely well established proof of placebo effect in non-random, non-blind tests. Tell a patient that he is getting a new miracle drug, and magically, a certain number just get well.....even on sugar pills. The fact that this had 100% good outcomes is helpful in pressing the case that it is a real effect.
All that said, the drug has been around for a long time, has been used for chronic disease, is apparently extremely well known to be "generally safe". That at least partially eliminates the biggest boogeyman in testing new drugs, you are, in this case, very unlikely to kill someone with the drug. Next is "does it work"? It seems very reasonable to put some caveats around this and approve it for use in some sort of a "large scale testing" mode, with clear notification of patients that this IS NOT A PROVEN, GUARANTEED SAFE TREATMENT, and that they can choose whether to get it or not, with the risk on them. Require a signed consent.
But, get the damned FDA bureaucrats out of the way. It is still entirely possible that this will be proven to be only moderately effective, or even, possibly, ineffective. But it could be very effective and save a bunch of lives. I can tell you that if I get this, I will be lobbying my doc to try it.
8 people like this.
Doctors need to tell this Clinton "medical expert" that their patients all need this drug because they are all suspected of having Lupus and proceed with the cure.
5 people like this.
Reply 21 - Posted by:
DVC 3/22/2020 10:17:37 AM (No. 354033)
Oh, and IMO, quoting Chinese "science" at this time, on this subject weakens your case rather than strengthens it. I think that everything in China about this is ENTIRELY suspect, and should be just ignored.
4 people like this.
Reply 22 - Posted by:
MuncsSister 3/22/2020 10:21:07 AM (No. 354038)
#6, #14:
I have taken this drug in the past for RA. It is affordable and has been in use for 70 years. Yes, long term use of this drug can, in rare cases, cause eye damage. That is why rheumatologists require baseline vision tests for people taking it long term so they can catch vision changes and stop taking the drug. The damage is not sudden onset. Nowhere have I seen that people will need to take this drug as long term therapy for the China Virus.
The “Malaria drug” headline conjures up all kinds of scary images for people and that’s exactly why the press is using that term. Fortunately, this drug is one of the most well researched drugs ever, given its long history. The same cannot always be said for countless other drugs millions of people take every day without a second thought.
Common sense must prevail here!
24 people like this.
Reply 23 - Posted by:
HotRod 3/22/2020 10:28:11 AM (No. 354054)
An earlier story explained that President Trump made his fortune by demanding results from his people. He should replace Fauci, who it seems is now nothing more than a bureaucrat, not doing much actual work in the field. Foot-dragging and bureaucratic process has it's (limited) place, but right now we need more action! We need fresh blood in all our agencies.
6 people like this.
Reply 24 - Posted by:
greggojo 3/22/2020 10:28:48 AM (No. 354055)
I think this should be a Must Read.
4 people like this.
Reply 25 - Posted by:
jeffkinnh 3/22/2020 10:37:41 AM (No. 354069)
With patient approval, give it to people with serious symptoms and also to those with emerging symptoms. See what happens. The false response that some placebo's cause for certain conditions is probably not much of an issue for a viral infection. Say it only works for on 50% of the people who get it. Isn't that pretty good? It doesn't mean that other medications can't continue to be tested or developed. If we COULD have an immediate, highly effective, low complication, low cost, solution for this virus, isn't it worth trying it?
You don't even need FDA "approval" just acceptance that the drug is safe for people testing positive for the Chinese virus with some known side effects and with effectiveness still under evaluation.
Think of it like this. A man has fallen through the ice on a lake. All you have is a ball of heavy twine. You're not sure the twine is strong enough to pull the guy out. A friend runs back to get a rope but it will be 15 minutes before he gets back and the guy will likely have drowned by then. Do you not use the twine because it might not work or do you give it a try? Duh!
Bureaucrats would let the guy drown because the twine is not rated for such rescue work.
10 people like this.
Reply 26 - Posted by:
coldoc 3/22/2020 10:46:27 AM (No. 354077)
The FDA has a long history of poo-pooing anything they didnt invent or discover. It looks as if fauci will have blood on his hands.
8 people like this.
Reply 27 - Posted by:
MainelySane 3/22/2020 11:02:32 AM (No. 354092)
#14... about blindness with hydroxycholorquine. I'm an optometrist and we follow patients yearly or more frequently for ocular side effects of hydroxy (Plaquenil). It takes years of unattended use of Plaquenil to cause retinal toxicity. Taking it for several weeks or months will not cause retinal toxicity.. and if you really already have macular degeneration and have lost central vision.. you have nothing more to lose... For me... given the choice of painful death or loss of central vision, I'd take loss of central vision before I would die.
15 people like this.
Reply 28 - Posted by:
earlybird 3/22/2020 11:03:24 AM (No. 354094)
From the AJMC (American Journal of Managed Care) yesterday:
The FDA has approved the first point-of-care test for coronavirus that can get results in 45 minutes, and New York state will conduct a trial of the drug combination that could be used to treat the novel coronavirus COVID-19.
https://www.ajmc.com/newsroom/fda-approves-rapid-coronavirus-test-new-york-state-to-conduct-trial-on-drug-combo-
0 people like this.
I took some version of HQuin almost every day for 8 years in Vietnam.
It’s safe. Better than the stuff that made our urine blue.
7 people like this.
Reply 30 - Posted by:
Tusker 3/22/2020 11:31:31 AM (No. 354130)
Welcome to this thread: a circular firing squad of blabbering “talking heads” all of whom have been inside too long eschewing faith, flailing around trying to beat death.
The same goes for Mini Doc, in spades who has NO solution and is not looking for one.
Meanwhile...tick, tick, tick.
5 people like this.
Reply 31 - Posted by:
JackBurton 3/22/2020 11:33:25 AM (No. 354135)
China has made chloroquine a standard treatment.
Infections are down. Deaths have stopped. Recoveries are almost total.
It's what the good doctor calls anecdotal.
6 people like this.
Reply 32 - Posted by:
jj1319 3/22/2020 11:48:25 AM (No. 354158)
Thanks, #8. Very well done.
I tell my guys, "Safety last. Right after quality and productivity."
So, essentially, safety third. We're all grown men who know a bit about responsibility.
3 people like this.
Reply 33 - Posted by:
Jesuslover54 3/22/2020 11:48:48 AM (No. 354159)
Hydroxychloroquine has been an approved drug for decades. This is just using it off-label.
4 people like this.
Reply 34 - Posted by:
Skeptical1 3/22/2020 12:05:32 PM (No. 354174)
Quite a rant. Yes, Fauci should have said "investigational" instead of "anecdotal", and lost some crredibility as a result. But if you read the Belgian guidelines, they only want it to be used on patients who have been hospitalized already. Which is a little late if the problem is lack of hospital beds (although obviously reduction in length of stay, not to mention mortality, would be a very good thing).
Anyway, with all that's happening, if the drug really works as hoped, we'll know very quickly. And you can bet that DJT will steamroller any FDA foot-dragging.
3 people like this.
Reply 35 - Posted by:
Chuzzles 3/22/2020 12:09:50 PM (No. 354181)
Given that he has been exposed as a Hildabeest fan this weekend, why has that man not been fired? Delay of vital therapies is so wrong, and so democrat. Trump is so weak in hiring people, then not getting rid of them when their skeletons are exposed. Why does Wray still have a job? Now this guy.
3 people like this.
Reply 36 - Posted by:
Chuzzles 3/22/2020 12:11:13 PM (No. 354186)
#2, that is not the Feds doing the whipping, that is the MEDIA. Sounds like the Feds have too many swampers who still believe what they hear in the media.
1 person likes this.
Reply 37 - Posted by:
john56 3/22/2020 12:12:11 PM (No. 354187)
Having sold Plaquenil (and chlorquine) in a past life, the major side effect is macular degeneration. The labeling on the product clearly states that patients should be tested for this at the time they start taking the drug and at least annually. Of course, that's for the treatment of Rheumatoid Arthritis, a chronic condition. Probably would be a good idea to have an eye test anyway to rule out any pre-existing condition, but as I understand it, the use of this drug and the arthrimoax (antibiotic) is a short term issue, only a few days or weeks of treatment.
Both those drugs are anti-malarial. Their RA effects were found when missionaries, sent to Africa and other areas with the drug, that had RA felt a relief of their RA. When the missionaries returned home and stopped the anti-malarial drugs, their symptoms returned. When they resumed taking the drugs, the symptoms were lessened.
4 people like this.
Reply 38 - Posted by:
FormerDem 3/22/2020 12:14:45 PM (No. 354193)
Fire Fauci.
3 people like this.
Reply 39 - Posted by:
MainelySane 3/22/2020 12:53:12 PM (No. 354245)
Google this: Hydroxychloroquine and azithromycin as a treatment of COVID-19 IHU Méditerranée-Infection select video.. the first hit should be the English language interview with the French Dr. who shared his results last week. His cocktail works by changing the pH of the lung environment making it an inhospitable environment for replication of the virus.
5 people like this.
Reply 40 - Posted by:
Ketchuplover 3/22/2020 4:25:02 PM (No. 354448)
Too much instant fame can go to anyone's head. Anybody else remember General Alexander Haig's (Sec. of State) press conference after Reagan was shot? "I'm in control here."
2 people like this.
Reply 41 - Posted by:
Rumblehog 3/22/2020 4:36:08 PM (No. 354456)
The FDA needs to be abolished. It's been corrupt to the hilt for decades, as Congress-critters' use it for the personal "ATM" with 'insider trading' bonuses. The FDA does nothing but slow down deployment of much needed drugs. But here's the main reason for shutting it down:
"FDA Approval" does NOT eliminate remove the threat that a drug manufacturer can be sued. If having FDA Approval could indemnify from lawsuits then the FDA would add value, but it doesn't. Bottom line is that "big-Pharma" has a much higher exposure to lawsuits in today's litigious environment which keeps them on the straight and narrow. Let the FDA go after the snake-oil hucksters, but leave the major drug companies alone to quickly churn out new medicines in times of crisis.
0 people like this.
Reply 42 - Posted by:
Rubinski 3/23/2020 8:18:32 AM (No. 354901)
This is a neutral comment, just meant to inform. FYI: It was the FDA approval system that saved America from the Thalidomide tragedy which saw so many children born in Europe and other parts of the world with deformed or missing limbs. The FDA would not approve its use in the US.
2 people like this.
Reply 43 - Posted by:
NotaBene 3/23/2020 5:46:01 PM (No. 355557)
This is a national emergency. Get factories producing enough hydro-Chloroquine. Give it off-label to any patient that wants it. To test for prophylaxis use doctors and nurses double blinded tests and they will use self-medication.
Taiwan, Singapore, South Korea and China have this pest beaten. What is the difference with us? They use MASKS of the surgical cheap type. Masks for everyone in the streets will bring social distancing automatically. We need to get back to work! Shorten the recession, this is now a political decision that cannot be up to doctors. Hydro-chloroquine for all ! Testing for all, and we need a serological test to see who was infected and is immune. A vaccine never w
0 people like this.
Comments:
Fauci is absolutely wrong to call the evidence "anecdotal." Other nations have adopted the drug he is delaying, to excellent effect.