So Dr. Fauci, what is YOUR plan for the early treatment of COVID-19?
It’s evident that, unless antiviral measures initiated soon after COVID-19 becomes symptomatic succeed in slowing down spread of the virus, giving the immune response a chance to snuff it out, there is a very significant chance that in high risk patients it will spread throughout the lungs and trigger a massive immune attack that literally drowns the patient in his own inflammatory fluids – a death by slow drowning. And we are now learning that, even in patients who manage to ride out the infection at home, many of these will sustain damage to heart tissue that may prove permanent. All of which means that slowing down viral replication and spread with early treatment is an urgent necessity.
So what is YOUR plan for early treatment, Dr. Fauci?
You have had nice things to say about remdesivir. As the Church Lady would say, “Well, isn’t that special?!” Remdesivir requires intravenous administration once daily – which means that it is inappropriate for use in early-stage patients sheltering at home. Which is probably why there have been no studies assessing its efficacy in such patients. And a course of remdesivir is quite expensive – an issue of some importance when over a million Americans have been afflicted with COVID-19.
So what is YOUR plan for early treatment, Dr. Fauci? Maybe Tylenol and bedrest? Tell us, do!
It seems to me that your chief contribution to discussion of early treatment for COVID-19 has been to ridicule hydroxychloroquine-based protocols that doctors around the world and throughout the US believe have been helping their early-stage patients. Dr. Fauci is right that in fact these protocols have not – at least so far - been proven effective in placebo-controlled randomized clinical trials that are the gold standard of medical proof. Indeed. Perhaps this is attributable in part to the fact that your own agency initiated a multi-center placebo-controlled randomized trial of early hydroxychloroquine/azithromycin in May – and then pulled the plug on it in June owing to slow patient enrollment. Instead of revving up efforts to recruit patients, the study was simply cancelled.
But you go farther than that with hydroxychloroquine per se. You tell us flatly that it has been proven NOT to work. This is really a mite irrelevant, given that few if any doctors are using hydroxychloroquine ALONE in their early-treatment protocols – it is claimed to synergize with the antibiotic azithromycin and the mineral zinc. And clinics worldwide that have used this protocol on large numbers of early-stage patients are reporting a great reduction in need for hospitalization, and mortality rates about a tenth those of nations which don’t employ hydroxychloroquine-based early treatments. But we’ll humor you and consider your claims about hydroxychloroquine alone.
So what is your gold standard PROOF that early hydroxychloroquine DOESN’T work? Almost all of the “gold standard” studies evaluating hydroxychloroquine in COVID-19 have addressed its use in hospitalized patients – and hence are irrelevant to evaluating hydroxychloroquine use in outpatients, as their authors acknowledge. We’ll note in passing that two of these studies – the RECOVERY and SOLIDARITY trials – inexplicably employed grossly excessive loading doses of the drug that some analysts suspect may have contributed to early deaths in patients. And the data from the NIH-sponsored trial have not yet been made public. In opposition to this, five retrospective studies evaluating patients receiving hydroxychloroquine soon after hospitalization have concluded that this drug likely decreases mortality rates by 30-56%. But let’s get back to early treatment.
Your “proof” that hydroxychloroquine does not work in early treatment is presumably the early treatment protocol of Dr. David Boulware. This was an odd study in which the patients were treated by mail, efficacy was evaluated solely by patient self-report, a high proportion of those enrolled did not have laboratory confirmation that they actually had COVID-19, and the majority of the patients enrolled were low-risk and would have recovered uneventfully with no treatment – there was only one death in those receiving placebo.
But the worst aspect of this study is that it was terminated very prematurely – at a time when ALL trends in the data favored hydroxychloroquine. The study was ended when it had enrolled only about a fourth as many subjects as was originally planned – which makes it hard for trends in data to achieve statistical significance. Notably, advocates of hydroxychloroquine-based early therapy maintain that it reduces need for hospitalization. In the Boulware study, half as many who received hydroxychloroquine were hospitalized for COVID-19 as among those who received placebo (4 vs 8). But that difference didn’t achieve statistical significance because the study was too small.
Why did the organizers of the study terminate it so abruptly – particularly when promising trends favoring hydroxychloroquine had emerged? Those of an uncharitable frame of mind might be prone to wonder whether the study was terminated quickly because its organizers feared that a longer study might prove hydroxychloroquine’s efficacy. I fervently hope that the organizers were more honorable than that.
Apparently, Dr. Fauci expects us to believe that an undersized study with multiple irregularities, in which ALL trends for reduction in days of symptoms favored hydroxychloroquine, and half as many patients were hospitalized in the hydroxychloroquine arm as in the placebo arm, constitutes gold standard proof that hydroxychloroquine is useless in early-stage COVID-19. Yes, that is precisely what he expects us to believe, and the media have been hard at work to insure that we believe it.
I reiterate, what is YOUR plan for early treatment of COVID-19, Dr. Fauci?
The health agencies of most governments, in the absence of gold standard proof for any specific regimen, have nonetheless issued guidelines for early treatment based on the totality of evidence which IS available. Many of these health agencies, cognizant of the fact that 75% of all reported clinical studies with hydroxychloroquine-based therapies have yielded positive outcomes, and that large reported case series with hydroxychloroquine-based early treatment have described impressive results, have recommended such therapies for early treatment. Is it sheer coincidence that case-fatality rates in these countries tend to be much lower than that in the US and other nations that have disdained early treatment protocols?
The medical tradition of validating the safety and efficacy of a drug in multiple placebo-controlled randomized studies before allowing its use makes a good deal of sense if one is dealing with a disorder such as, say, rheumatoid arthritis, for which multiple proven therapies already exist. But the situation is very different when we are faced with a disease, slaughtering hundreds of thousands in its path, for which no proven therapy exists. In the latter circumstance, in light of the fact that gold standard studies take a great many months to organize and complete, the course of wisdom is to settle provisionally on a therapeutic strategy which seems likely to work based on initial clincal reports and studies, as well as on theoretical considerations. Which is what doctors employing hydroxychloroquine are doing.
By failing to make even provisional recommendations for early treatment of COVID-19, Dr. Fauci has been grossly derelict in his duty to protect the American people. And you can add to this indictment all of the politicized media hacks and all of the self-important but half-bright medical academicians who have joined in full-throated denunciation of hydroxychloroquine, raising ridiculous concerns regarding its safety and proclaiming it to be proven useless when in fact no such proof exists.
Dr. Fauci, over 160,000 Americans have died so far from this scourge while in effect you have stood with your hands in your pockets allowing early-stage patients to go untreated until they had to run in desperation to emergency rooms, often gasping for breath. It’s not nearly enough to encourage vaccine development or to tout drugs like remdesivir suitable only for use in very ill hospitalized patients. You have failed grossly in your obligations to the American people, and should resign so that your place can be filled by someone with common sense and humane instincts.