FDA Must Approve Hydroxychloroquine Now

[Editor's note: Lack of FDA approval does not prohibit off-label use of drugs for other threapeutic purposes, but would inhibit widespred use.]

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.

Fauci, speaking from the White House, said on the matter of approving Hydroxychloroquine and azithromycin:

"It's it's essentially what I said multiple times from this podium. Is that when you have, first of all, we're trying to develop de novo drugs that are not yet out there, not that approved, that ultimately will be effective. And the way you prove that is to  do a randomized controlled trial to prove safety and efficacy. Uh, I am not a totally sure what the the President was referring to, but I believe he's referring to a report that used both Hydroxychloroquine and azithromycin together uh to have some uh possibility of being an effect. Many of the things that you hear out there are are what I had called anecdotal reports. They may be true. But they’re anecdotal."

Please notice that Dr. Fauci just called the effectiveness of Hydroxychloroquine and azithromycin against COVID19 anecdotal.  That will be very important in a moment.

Fauci continued, "So the only thing that I was saying is that if you really want to definitively know if something works that you've gotta do the kind of trial that you get the good information," by which he dismissed the body of scientific work that supports the use of Hydroxychloroquine.

Fauci went on,

"The President is talking about hope for people and it's not an unreasonable thing to hope for people so when you have approved drugs that physicians have the option and a decision between the physician and the patient are you gonna use the drug that someone says from an anecdotal standpoint not completely proven but might have some effect..."

Which is utterly gobbledygook divergent from the facts about the two drugs in discussion.  It is not true that the evidence supporting these two drugs is anecdotal. These two drugs have been shown in scientific studies and peer-reviewed publications to have strong positive effects against COVID19. Period.

But Fauci's words have hidden the truth from you.

Fauci rambled,

"...there are those who lean to the point of giving hope and saying give that person the option of having access to that drug and then you have the other group which is my job as scientist to say my job is to ultimately prove without a doubt that a drug is not only safe but that it actually works."

No. The standard of evidence he is requiring is not his job as a scientist.  It is a wildly inappropriate exaggeration utterly unsuited to the situation, and his description of the facts is utterly misleading. Not to mention it's a word-salad.

In one month's time, there will be hundreds of thousands of cases of COVID19.  There will be many thousands of deaths.  And 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.

Fauci said these fantastically vague, wrong, and misleading things from the podium at the White House Coronavirus Task Force briefing with the Vice President standing behind him.

 

Are the studies supporting Hydroxychloroquine and azithromycin really anecdotal evidence?

Definition of "anecdotal evidence" from Merriam-Webster:

evidence in the form of stories that people tell about what has happened to them.

Example: His conclusions are not supported by data; they are based only on anecdotal evidence.

Is that what the following is?

Gautret et al. (2020) writing Hydroxychloroquine and azithromycin as a treatment of COVID‐19: results of an open‐label non‐randomized clinical trial. state:

"We therefore recommend that COVID-19 patients be treated with Hydroxychloroquine and azithromycin to cure their infection and to limit the transmission of the virus to other people in order to curb the spread of COVID-19 in the world." - Gautret et al, International Journal of Antimicrobial Agents – In Press 17 March 2020 – DOI : 10.1016/j.ijantimicag.2020.105949

The words "clinical trial" in the title actually mean "clinical trial". That's, like, different, than "anecdotal", Tony?

Then we hear from Wang, M., Cao, R., Zhang, L. et al. in Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res 30, 269–271 (2020).

Wang et al writes,

"Our findings reveal that remdesivir and chloroquine are highly effective in the control of 2019-nCoV infection in vitro. Since these compounds have been used in human patients with a safety track record and shown to be effective against various ailments, we suggest that they should be assessed in human patients suffering from the novel coronavirus disease."

That's scientific evidence was published in Nature Cell Research - probably the most prestigious scientific journal in that field in the world.  Nature is "anecdotal evidence" to Dr. Tony "lost the fastball" Fauci.

But perhaps I do not know how to interpret this scientific result properly - right? I am a scientist. Yet, maybe I'm a rube?  A deplorable perhaps?  I am definitely not Medal of Freedom winner! So maybe the plain English "clinical trial" doesn't mean "clinical trial."  So we'd better not take my word for it.

Let's take Belgium's word for it, instead.

Belgium has issued official guidelines calling for use of Hydroxychloroquine as a first-line treatment for COVID19. See page 3 and 4 of link below.

One stated reason:

"Results of Gautret’ study have been just released and confirm that viral positivity in respiratory secretions (measured by PCR) is significantly decreased at day 6 in Hydroxychloroquine-treated COVID-19 patients (n=26) versus those with supportive care (n=16 controls): 30% positivity versus 87.5%, p<0.001). This observation strongly supports the current choice of Hydroxychloroquine as first-line treatment; we suggest to keep the current recommended dosage (see Table), which is pharmacologically very close to that used in Gautret’s study. "

That "Guatret study" that Belgium references is a scientific one! Not a ramble told while drunk on the job in D.C.!  The nation of Belgium stating emphatically that the "current choice of Hydroxychloroquine as first-line treatment" is justified because of its review of the science... is irrelevant to the Fauci poo-poo. But his name was not on the paper so it didn't matter?  The official position of an entire European country offering official guidance to every doctor in the land during a 100-year epidemic is...just an anecdote.

That is, it's an anecdote to a preening narcissist bureaucrat in Washington D.C. for whom no evidence is sufficient...unless HE says so with cameras on him!  I'm sure the Belgians are impressed.

But again don't take my word. Take China's.

China includes chloroquine in the recommendations regarding the prevention and treatment of COVID-19 pneumonia, so reported in International Journal of Microbial Agents:

If you get COVID19 in China, the official guidance to doctors says to give you Hydroxychloroquine. 

"The  drug  is  recommended  to  be  included  in  the  next  version  of  the  Guidelines  for  the  Prevention,  Diagnosis,  and  Treatment  of  Pneumonia  Caused  by  COVID-19  issued  by  the  National  Health  Commission  of  the  People's Republic of China for treatment of COVID-19 infection in larger populations in the future."

You may read more about the official Chinese national guidance to all doctors in the scientific journal Bioscience Trends.  A journal apparently considered to be a twitter feed by the blathering Fauci.

Why do you think China has had such a radical improvement in its caseload?  There are a collection of papers online in broken English, written by excited Chinese medical doctors, telling the world they are using Chloroquine and it's very effective.

China may be a lot of things.  But they are not dumb. Politically, the government there is glad enough to look like heroes for issuing orders to give everyone chloroquine, because it will save the lives of ten million Chinese.  You have to be a lifetime American bureaucrat to not figure this out.

Official government guidance to doctors! From the world's most populous nation! With the largest COVID19 infection! Which has shown the largest drop in caseload! This is "anecdotal evidence" to Dr. Fauci and America's FDA.  These imbeciles are so busy making the paperwork go faster for you (while America plunges into the grave, and the fix is on the shelf at Walmart?) that they are incapable of noticing anything that happens outside the beltway. But don't you feel better that he has a Medal of Freedom?  And that a month from now, he'll get back to you about that pill-thing?

Two national governments, multiple peer reviewed studies, a clinical trial, the most prestigious journals -  these are not high-enough for Mr. Medal Dr. MD-PhD Fauci.  He's above all that. Maybe the type of the research - performed by your beltway buddies - dismissing the work of the French, the Chinese, and the Belgians -  is more important than ten thousand innocent lives plunging into the mass-grave dug with a back-hoe? After all, you're big MF, MD-PhD, on TV! The standards must be impossibly high.

So high the little people can't meet them.

While thousands of Americans lie dying, the citizens of Belgium and France and China are given Hydroxychloroquine and are recovering. Having gotten off their butts and done the research those nations, while Fauci and FDA was strutting around wondering how to fill out paperwork faster, deserve credit for publishing actionable scientific conclusions.

But maybe Fauci and FDA will get back to you in the "record time" of one month?  You know, when there's a million cases and two hundred thousand in the hospital, a hundred thousand in ICU and twenty thousand dead.  The very careful, very safe Lost the Fastball Fauci, for whom no scientific evidence is anything but anecdotal, will let you die, because there's not evidence rising to his august level, to give you a pill that has been shown by science to heal you.

Demand Fauci's resignation.

Demand FDA Director Hahn's resignation.

Because it sounds to me like these two elitist snobs would rather let you die than give you the most studied prescription-medication in the history of mankind.

FDA must approve Hydroxychloroquine NOW for COVID19.

Not just "off label".

Not just "compassionate use only"

Not just "limited clinical trial".

Full FDA approval, NOW.

That simple approval will change the number of people getting the medicine from hundreds to hundreds of thousands.

Why should we do this?  Because of anecdote and emotion?

No.

Because the scientific, peer reviewed, journal articles and clinical trial provide concrete evidence of efficacy. 

And?

Because chloroquine is the single most studied prescription in the history of the Earth, having proven its safety via tens of millions of patients in hundreds of millions of doses over seven decades, in every country in the world, by tens of thousands of doctors.  There are hundreds of scientific journal articles on the safety of chloroquine. There are tens of thousands of papers on its properties. There is more evidence for the safe-use applications of chloroquine than for any other prescribed drug in the history of man. To question whether it's safe isn't just to insult the intelligence of America - it is an obtuse insult the entire body of published medicine.

And why today and not in a month?

Because in about one month, every one of the 924,107 staffed hospital beds (American Hospital Association) in the United States of America will be filled with the sick and the dying.

Fauci lied, people died. Get him and Hahn outta here.

Photo credit: YouTube screen grab

[Editor's note: Lack of FDA approval does not prohibit off-label use of drugs for other threapeutic purposes, but would inhibit widespred use.]

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.

Fauci, speaking from the White House, said on the matter of approving Hydroxychloroquine and azithromycin:

"It's it's essentially what I said multiple times from this podium. Is that when you have, first of all, we're trying to develop de novo drugs that are not yet out there, not that approved, that ultimately will be effective. And the way you prove that is to  do a randomized controlled trial to prove safety and efficacy. Uh, I am not a totally sure what the the President was referring to, but I believe he's referring to a report that used both Hydroxychloroquine and azithromycin together uh to have some uh possibility of being an effect. Many of the things that you hear out there are are what I had called anecdotal reports. They may be true. But they’re anecdotal."

Please notice that Dr. Fauci just called the effectiveness of Hydroxychloroquine and azithromycin against COVID19 anecdotal.  That will be very important in a moment.

Fauci continued, "So the only thing that I was saying is that if you really want to definitively know if something works that you've gotta do the kind of trial that you get the good information," by which he dismissed the body of scientific work that supports the use of Hydroxychloroquine.

Fauci went on,

"The President is talking about hope for people and it's not an unreasonable thing to hope for people so when you have approved drugs that physicians have the option and a decision between the physician and the patient are you gonna use the drug that someone says from an anecdotal standpoint not completely proven but might have some effect..."

Which is utterly gobbledygook divergent from the facts about the two drugs in discussion.  It is not true that the evidence supporting these two drugs is anecdotal. These two drugs have been shown in scientific studies and peer-reviewed publications to have strong positive effects against COVID19. Period.

But Fauci's words have hidden the truth from you.

Fauci rambled,

"...there are those who lean to the point of giving hope and saying give that person the option of having access to that drug and then you have the other group which is my job as scientist to say my job is to ultimately prove without a doubt that a drug is not only safe but that it actually works."

No. The standard of evidence he is requiring is not his job as a scientist.  It is a wildly inappropriate exaggeration utterly unsuited to the situation, and his description of the facts is utterly misleading. Not to mention it's a word-salad.

In one month's time, there will be hundreds of thousands of cases of COVID19.  There will be many thousands of deaths.  And 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.

Fauci said these fantastically vague, wrong, and misleading things from the podium at the White House Coronavirus Task Force briefing with the Vice President standing behind him.

 

Are the studies supporting Hydroxychloroquine and azithromycin really anecdotal evidence?

Definition of "anecdotal evidence" from Merriam-Webster:

evidence in the form of stories that people tell about what has happened to them.

Example: His conclusions are not supported by data; they are based only on anecdotal evidence.

Is that what the following is?

Gautret et al. (2020) writing Hydroxychloroquine and azithromycin as a treatment of COVID‐19: results of an open‐label non‐randomized clinical trial. state:

"We therefore recommend that COVID-19 patients be treated with Hydroxychloroquine and azithromycin to cure their infection and to limit the transmission of the virus to other people in order to curb the spread of COVID-19 in the world." - Gautret et al, International Journal of Antimicrobial Agents – In Press 17 March 2020 – DOI : 10.1016/j.ijantimicag.2020.105949

The words "clinical trial" in the title actually mean "clinical trial". That's, like, different, than "anecdotal", Tony?

Then we hear from Wang, M., Cao, R., Zhang, L. et al. in Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res 30, 269–271 (2020).

Wang et al writes,

"Our findings reveal that remdesivir and chloroquine are highly effective in the control of 2019-nCoV infection in vitro. Since these compounds have been used in human patients with a safety track record and shown to be effective against various ailments, we suggest that they should be assessed in human patients suffering from the novel coronavirus disease."

That's scientific evidence was published in Nature Cell Research - probably the most prestigious scientific journal in that field in the world.  Nature is "anecdotal evidence" to Dr. Tony "lost the fastball" Fauci.

But perhaps I do not know how to interpret this scientific result properly - right? I am a scientist. Yet, maybe I'm a rube?  A deplorable perhaps?  I am definitely not Medal of Freedom winner! So maybe the plain English "clinical trial" doesn't mean "clinical trial."  So we'd better not take my word for it.

Let's take Belgium's word for it, instead.

Belgium has issued official guidelines calling for use of Hydroxychloroquine as a first-line treatment for COVID19. See page 3 and 4 of link below.

One stated reason:

"Results of Gautret’ study have been just released and confirm that viral positivity in respiratory secretions (measured by PCR) is significantly decreased at day 6 in Hydroxychloroquine-treated COVID-19 patients (n=26) versus those with supportive care (n=16 controls): 30% positivity versus 87.5%, p<0.001). This observation strongly supports the current choice of Hydroxychloroquine as first-line treatment; we suggest to keep the current recommended dosage (see Table), which is pharmacologically very close to that used in Gautret’s study. "

That "Guatret study" that Belgium references is a scientific one! Not a ramble told while drunk on the job in D.C.!  The nation of Belgium stating emphatically that the "current choice of Hydroxychloroquine as first-line treatment" is justified because of its review of the science... is irrelevant to the Fauci poo-poo. But his name was not on the paper so it didn't matter?  The official position of an entire European country offering official guidance to every doctor in the land during a 100-year epidemic is...just an anecdote.

That is, it's an anecdote to a preening narcissist bureaucrat in Washington D.C. for whom no evidence is sufficient...unless HE says so with cameras on him!  I'm sure the Belgians are impressed.

But again don't take my word. Take China's.

China includes chloroquine in the recommendations regarding the prevention and treatment of COVID-19 pneumonia, so reported in International Journal of Microbial Agents:

If you get COVID19 in China, the official guidance to doctors says to give you Hydroxychloroquine. 

"The  drug  is  recommended  to  be  included  in  the  next  version  of  the  Guidelines  for  the  Prevention,  Diagnosis,  and  Treatment  of  Pneumonia  Caused  by  COVID-19  issued  by  the  National  Health  Commission  of  the  People's Republic of China for treatment of COVID-19 infection in larger populations in the future."

You may read more about the official Chinese national guidance to all doctors in the scientific journal Bioscience Trends.  A journal apparently considered to be a twitter feed by the blathering Fauci.

Why do you think China has had such a radical improvement in its caseload?  There are a collection of papers online in broken English, written by excited Chinese medical doctors, telling the world they are using Chloroquine and it's very effective.

China may be a lot of things.  But they are not dumb. Politically, the government there is glad enough to look like heroes for issuing orders to give everyone chloroquine, because it will save the lives of ten million Chinese.  You have to be a lifetime American bureaucrat to not figure this out.

Official government guidance to doctors! From the world's most populous nation! With the largest COVID19 infection! Which has shown the largest drop in caseload! This is "anecdotal evidence" to Dr. Fauci and America's FDA.  These imbeciles are so busy making the paperwork go faster for you (while America plunges into the grave, and the fix is on the shelf at Walmart?) that they are incapable of noticing anything that happens outside the beltway. But don't you feel better that he has a Medal of Freedom?  And that a month from now, he'll get back to you about that pill-thing?

Two national governments, multiple peer reviewed studies, a clinical trial, the most prestigious journals -  these are not high-enough for Mr. Medal Dr. MD-PhD Fauci.  He's above all that. Maybe the type of the research - performed by your beltway buddies - dismissing the work of the French, the Chinese, and the Belgians -  is more important than ten thousand innocent lives plunging into the mass-grave dug with a back-hoe? After all, you're big MF, MD-PhD, on TV! The standards must be impossibly high.

So high the little people can't meet them.

While thousands of Americans lie dying, the citizens of Belgium and France and China are given Hydroxychloroquine and are recovering. Having gotten off their butts and done the research those nations, while Fauci and FDA was strutting around wondering how to fill out paperwork faster, deserve credit for publishing actionable scientific conclusions.

But maybe Fauci and FDA will get back to you in the "record time" of one month?  You know, when there's a million cases and two hundred thousand in the hospital, a hundred thousand in ICU and twenty thousand dead.  The very careful, very safe Lost the Fastball Fauci, for whom no scientific evidence is anything but anecdotal, will let you die, because there's not evidence rising to his august level, to give you a pill that has been shown by science to heal you.

Demand Fauci's resignation.

Demand FDA Director Hahn's resignation.

Because it sounds to me like these two elitist snobs would rather let you die than give you the most studied prescription-medication in the history of mankind.

FDA must approve Hydroxychloroquine NOW for COVID19.

Not just "off label".

Not just "compassionate use only"

Not just "limited clinical trial".

Full FDA approval, NOW.

That simple approval will change the number of people getting the medicine from hundreds to hundreds of thousands.

Why should we do this?  Because of anecdote and emotion?

No.

Because the scientific, peer reviewed, journal articles and clinical trial provide concrete evidence of efficacy. 

And?

Because chloroquine is the single most studied prescription in the history of the Earth, having proven its safety via tens of millions of patients in hundreds of millions of doses over seven decades, in every country in the world, by tens of thousands of doctors.  There are hundreds of scientific journal articles on the safety of chloroquine. There are tens of thousands of papers on its properties. There is more evidence for the safe-use applications of chloroquine than for any other prescribed drug in the history of man. To question whether it's safe isn't just to insult the intelligence of America - it is an obtuse insult the entire body of published medicine.

And why today and not in a month?

Because in about one month, every one of the 924,107 staffed hospital beds (American Hospital Association) in the United States of America will be filled with the sick and the dying.

Fauci lied, people died. Get him and Hahn outta here.

Photo credit: YouTube screen grab