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Hydrochloroquine wars, 2: a NY physician speaks of “hundreds” of successful patients, a Governor bans use in Nevada

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First, Dr Vladimir Zelenko speaks:

While, the Governor blocks:

Sisolak signed an emergency order earlier Tuesday barring the use of anti-malaria drugs for someone who has the coronavirus. But Sisolak’s order does not apply to patients who are hospitalized with coronavirus. The order restricting chloroquine and hydroxychloroquine came after President Donald Trump touted the medication as a treatment and falsely stated that the Food and Drug Administration had just approved the use of chloroquine to treat patients infected with coronavirus. Sisolak said in a statement that there’s no consensus among experts or Nevada doctors that the drugs can treat people with COVID-19.

Actually, as Pharmacy Times reported, Thu March 19:

Pharmacy Times

FDA Announces Two Drugs Given ‘Compassionate Use’ Status in Treating COVID-19
2020-03-19 17:40:00
Kristen Coppock, MA, Managing Editor

Two drugs, chloroquine and remdesivir, are being designated for Expanded Access, or “compassionate use,” by the FDA to address the novel coronavirus (COVID-19) pandemic, according to FDA Commissioner Stephen Hahn, MD, and President Donald Trump.1

Chloroquine and remdesivir are not FDA-approved for a COVID-19 indications, but Expanded Access allows patients with serious or life-threatening cases of the virus to have access to them as investigational medicinal products.2

Chloroquine, or hydroxychloroquine, is currently approved by the FDA for treatment of malaria, lupus, and rheumatoid arthritis, although not for COVID-19. A heme polymerase inhibitor, the drug is being tested for possible COVID-19 use to improve virologic clearance.3

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity, according to its maker, Gilead Sciences, and it is not approved by the FDA nor any other countries for any use. However, remdesivir has demonstrated activity against MERS and SARS, indicating that it may have potential activity against COVID-19. The drug has been used in a small number of patients with COVID-19 in an experimental manner, according to Gilead.4

During a White House press conference on Thursday, Hahn said that although remdesivir is still in its investigational phase, the unprecedented pandemic warranted action. “Remdesivir is [still] going through the normal process. We do need to know about the safety and effectiveness,” he said.1

According to Hahn, the FDA is providing regulatory flexibility and guidance, but is also continuing to ensure products are safe. He said the agency has been working with the CDC since January on combating the virus.1

“An important part of that work is expanding therapeutic options for the coronavirus,” Hahn said.1

Trump said these medications will be made available by prescription. Hahn declined to say when both drugs would become available for use in patients with COVID-19.1

For up-to-date information on COVID-19 for pharmacy professionals, visit Pharmacy Times’ coronavirus resource center.

Coronavirus Task Force. White House Press Conference. Presented: March 19, 2020. Accessed March 19, 2020.
FDA. Expanded Access. FDA website. Updated May 6, 2019. Accessed March 19, 2020.
Bulloch M. Potential Pipeline Medications May Help Patients with Novel Coronavirus. Pharmacy Times. Published March 11, 2020. Accessed March 19, 2020.
Gilead Sciences. Gilead Sciences Update On the Company’s Ongoing Response to COVID-19. Gilead Sciences website. Updated February 26, 2020. Accessed March 20, 2020.

So, we clearly have a case of half-truth here. FDA has not given FULL approval, but per Pharmacy Times, it has given permission for compassionate, exploratory use. Dr Zelenko has on his own professional responsibility gone ahead to use the drugs for early stage cases and has seen full success for “hundreds” of cases. From his description, he is operating in a community of 36,000 some 50 mi from NYC, where he estimates 20,000 are or have been infected with the Covid-19 virus.

At the same time, Nevada’s Governor claims lack of consensus and bans use (there seems to be a hospitalisation exemption). Fair comment, this last does not seem responsible (and may lead to needless loss of life), on readily accessible global evidence.

What do I mean?

Exhibit 1, Guandong, China [i.e. Canton]:

Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):185-188. doi: 10.3760/cma.j.issn.1001-0939.2020.03.009.

[Expert consensus on chloroquine phosphate for the treatment of novel coronavirus pneumonia].

[Article in Chinese; Abstract available in Chinese from the publisher]
multicenter collaboration group of Department of Science and Technology of Guangdong Province and Health Commission of Guangdong Province for chloroquine in the treatment of novel coronavirus pneumonia.

Abstract in English, Chinese

At the end of December 2019, a novel coronavirus (COVID-19) caused an outbreak in Wuhan, and has quickly spread to all provinces in China and 26 other countries around the world, leading to a serious situation for epidemic prevention. So far, there is still no specific medicine. Previous studies have shown that chloroquine phosphate (chloroquine) had a wide range of antiviral effects, including anti-coronavirus. Here we found that treating the patients diagnosed as novel coronavirus pneumonia with chloroquine might improve the success rate of treatment, shorten hospital stay and improve patient outcome. In order to guide and regulate the use of chloroquine in patients with novel coronavirus pneumonia, the multicenter collaboration group of Department of Science and Technology of Guangdong Province and Health Commission of Guangdong Province for chloroquine in the treatment of novel coronavirus pneumonia developed this expert consensus after extensive discussion. It recommended chloroquine phosphate tablet, 500mg twice per day for 10 days for patients diagnosed as mild, moderate and severe cases of novel coronavirus pneumonia and without contraindications to chloroquine.

Similarly, Exhibit 2, on the French trials — and, recall, France is where co-discoverers of the HIV virus worked:

The Connexion

24 march 2020

A renowned research professor in France has reported successful results from a new treatment for Covid-19, with early tests suggesting it can stop the virus from being contagious in just six days.

Professor Didier Raoult from infection hospital l’Institut Hospitalo-Universitaire (IHU) Méditerranée Infection in Marseille (Bouches-du-Rhône, Provence-Alpes-Côte d’Azur), published a video explaining the trials on Monday March 16.

Professor Raoult is an infectious diseases specialist and head of the IHU Méditerranée Infection, who has been tasked by – and consulted by – the French government to research possible treatments of Covid-19.

He said that the first Covid-19 patients he had treated with the drug chloroquine had seen a rapid and effective speeding up of their healing process, and a sharp decrease in the amount of time they remained contagious.

Chloroquine – which is normally used mainly to prevent and treat malaria – was administered via the named drug, Plaquenil.

The treatment was offered to 24 patients, who were among the first to become infected in the south east of France, and who had voluntarily admitted themselves to hospital for the process.

Patients were given 600mcg per day for 10 days. They were closely monitored, as the drug can interact with other medication, and cause severe side effects in some cases.

Professor Raoult said: “We included everyone who was in agreement [to be treated], which was almost everyone. Two towns in the protocol, Nice and Avignon, gave us [infected] patients who had not yet received treatment.

“We were able to ascertain that patients who had not received Plaquenil (the drug containing hydroxychloroquine) were still contagious after six days, but of those that had received Plaquenil, after six days, only 25% were still contagious.”

Chloroquine phosphate and hydroxychloroquine have previously been used to treat coronavirus patients in China, in ongoing Covid-19 clinical trials . . . .

A new academic study, published on Friday March 13 by US scientific researchers, also said that chloroquine appeared to be an effective treatment, and appears to align with the findings in France.

It said: “Use of chloroquine (tablets) is showing favorable outcomes in humans infected with Coronavirus including faster time to recovery and shorter hospital stay…

“Research shows that chloroquine also has strong potential as a prophylactic (preventative) measure against coronavirus in the lab, while we wait for a vaccine to be developed.

“Chloroquine is an inexpensive, globally available drug that has been in widespread human use since 1945 against malaria, autoimmune and various other conditions…[it] can be prescribed to adults and children of all ages.

“It can also be safely taken by pregnant women and nursing mothers [and] has been widely used to treat human diseases, such as malaria, amoebiosis, HIV, and autoimmune diseases, without significant detrimental side effects.”

As further fair comment, it seems that the overwrought rhetoric over endorsement of the drug by US President Trump may be distorting our ability to reasonably assess the degree of warrant that it is credible that the drug is a potentially useful treatment for Covid-19. That may needlessly cost lives.

So, while indeed, we must be cautious about premature full endorsement, it is only reasonable to take on board evidence that the drug is effective, allow for significant use in the face of an emergency and by carrying out further trials, regularise the use [or, show that it is no better than the notorious placebo sugar pill].

We of course, are following up from an earlier UD Sci-Tech news watch post, here [which points to evidence from as long ago as 2005].

Perhaps, we need less cumbersome approaches in the face of a pandemic. END

32 Replies to “Hydrochloroquine wars, 2: a NY physician speaks of “hundreds” of successful patients, a Governor bans use in Nevada

  1. 1
    kairosfocus says:

    Hydrochloroquine wars, 2: a NY physician speaks of “hundreds” of successful patients, a Governor bans use in Nevada

  2. 2
    bornagain77 says:

    Of note:

    A man with coronavirus who works in LA says the drug used to treat malaria saved his life
    By Hailey Winslow – Published 2 days ago
    Excerpt: He says his doctors did not want to see him so he drove to Joe DiMaggio hospital in South Florida, near his home, and nearly passed out waiting to get tested. Doctors diagnosed him with pneumonia and coronavirus. They put him on oxygen in the ICU but he says he was still unable to breathe. After more than a week, he says doctors told him there was really nothing more they could do. Friday evening, he said goodbye to his wife and three children.
    “I was at the point where I was barely able to speak and breathing was very challenging. I really thought my end was there. I had been through nine days of solid pain and for me, the end was there. So I made some calls to say in my own way goodbye to my friends and family.” A dear friend immediately sent him a recent article about hydroxychloroquine, an old anti-malaria medicine proven successful to treat COVID-19 patients overseas, and insisted he take the drug.
    So, Giardinieri reached out to an infectious disease doctor. “He gave me all the reasons why I would probably not want to try it because there are no trials, there’s no testing, it was not something that was approved. And I said look I don’t know if I’m going to make it until the morning because at that point I really thought I was coming to the end because I couldn’t breathe anymore. He agreed and authorized the use of it and 30 minutes later the nurse gave it to me.
    ”An hour after an IV with the medicine, he says his heart felt like it was beating out of his chest. “They had to come in and get me calmed down and take care of me. I had another episode about two hours later where I just got to the point where I couldn’t breathe and my heart was pounding again so they gave me some Benadryl through the system and something else. I’m not sure what it was. It allowed me to go to sleep and when I woke up at exactly 4:45 in the morning, I woke up like nothing ever happened.”Miraculously, he’s since had no fever or pain, feels fine and he’s able to breathe again.
    Giardinieri says doctors now believe those episodes were not a reaction to the medicine but the virus progressing in his body. “To me, there was no doubt in mind that I wouldn’t make it until morning,” says Giardinieri. “So to me the drug saved my life.”
    On FOX 11’s “The Issue Is,” this week, Oncologist Dr. Paul Song says while using hydroxycloroquine to treat COVID-19 is still preliminary, it’s extremely compelling and hopeful with such an infectious virus.“A lot of people are walking around shedding viruses unknowingly and if you can’t eliminate this from the body in such a short period of time, then the potential to infect others is greatly diminished,” says Dr. Song.
    “Not to mention the recovery period for patients,” Giardinieri says, for him, it was life-saving.
    “I just want everyone to know there’s an option.,,,

  3. 3
    Ed George says:

    Until it is fully approved for use I would want it to be administered under a hospital setting where thy can be monitored. If it works as well as people hope, this will significantly shorten hospital stays for people and reducing the impact on the health care system.

  4. 4
    kairosfocus says:

    EG, please see the vid on what sounds interesting in NY; reportedly 350 cases. Chloroquine is a known factor as a drug. While idiots can and do kill themselves with it, safe and effective dosage is not a wild guess issue. KF

  5. 5
    bornagain77 says:

    Dr. Fauci Answer Busts Media’s Anti-Trump Narrative, Says ‘Of Course’ He’d Prescribe Chloroquine – March 25, 2020
    In an interview Tuesday night with a Philadelphia radio show, Dr. Anthony Fauci, the physician who’s become one of the most recognized faces on television during the COVID-19 crisis, said he wouldn’t hesitate to prescribe a known antimalarial drug to a patient who’d been infected with the coronavirus if there were no other option available.,,,
    But Fauci gave Stigall a different take. Asked point-blank whether he would be willing to prescribe it for a patient personally, as a physician, not as “the guy running the coronavirus task force right now,” his answer was unequivocal.
    “Yeah, of course, particularly if people have no other option. You want to give them hope,” he said.

  6. 6
    kairosfocus says:

    F/N: Here is a Townhall report on an interview with the renowned Dr Fauci:

    on AM 990 in Philadelphia, he talked with Townhall columnist and morning host Chris Stigall about the very real hope in the hydroxychloroquine drug that has been the buzz recently.

    “If you’re a doctor listening to me right now and a patient with coronavirus feels like they want to try that,” Stigall asked, “and you’re their doctor, you’re not Anthony Fauci the guy running the coronavirus task force, would you say ‘alright, we’ll give it a whirl’?”

    “Yeah, of course, particularly if people have no other option,” Fauci said. “These drugs are approved drugs for other reasons. They’re anti-malaria drugs, and they’re drugs against certain autoimmune diseases like lupus. Physicians throughout the country can prescribe that in an off-label way. Which means they can write it for something it was not approved for.”

    That sounds a lot like a conversational version of the FDA position of March 19 reported in the OP above.



  7. 7
    kairosfocus says:

    BA77, looks like you caught it too. KF

  8. 8
    ET says:

    The only place it should be administered is under a doctor’s care. You should be in the hospital by that phase of the illness. Your lungs are filling with fluid and you can barely breath. Those are the people who are getting that treatment.

    It’s the “when all else has failed”, solution.

  9. 9
    Ed George says:

    There is a reason we have a strict drug approval process. The approval on compassionate grounds is intended for advanced cases and under doctor’s supervision. Having your family doctor give you a prescription is not supervision. And, I would argue, it is irresponsible for doctors to do this until an effective dosage and frequency regime has been determined.

  10. 10
    kairosfocus says:

    EG, the not invented here syndrome practically reeks from what is being suggested. And if red tape is leading to inability to respond in good time to epidemics such as this, that is itself a message. KF

  11. 11
    Seversky says:

    We have a drug which showed promising results in a French trial that was based in a tiny cohort of 24 patients. Dr Fauci rated the results as little better than anecdotal.

    We have a drug for which a Chinese paper claims good results. Unfortunately, the Chinese government is known to exert strict control over any form of official publication to ensure their political acceptability. That seriously undermines its credibility.

    We have this video from someone who claims to be a family doctor who has had “tremendous” success in using this drug both as a prophylactic and therapeutic agent. None of this has been verified, which makes it just anecdotal at this point.

    We have a drug which is being touted by a president who is notorious as an habitual liar and who is clearly rating the health of the US economy as a higher priority than the health of its citizens. The lives that have been and may still be lost are being treated as acceptable casualties of this “war” against COVID-19. Acceptable to who? I seriously doubt that this president would find acceptable the loss of a member of his own family or friends but strangers don’t matter.

    I hope that hydroxychloroquine, either alone or in combination with azithromycin, can be proven effective against COVID-19. I also believe that the economic consequences of the current measures could be devastating and even more harmful than the disease itself.

    We need to be looking at all possible existing drugs that might be effective against this virus, not just chloroquine, and I assume that such research is under way. Obviously, we need a vaccine as soon as possible but the consensus seems to be that one will not be tested and approved until next year at the earliest.

    We also need to be looking at novel protective measures, such as UV light to kill the virus on exposed surfaces, including gloves worn to protect the hands. There should also be a full face mask which protects the eyes, nose and mouth, something like a diver’s full-face mask. The standard surgical mask is too loose-fitting, the N95 covers the nose and mouth but does not cover the eyes which are another known entry-point for infectious microorganisms. A cheap-to-make, close-fitting, full-face mask, coupled with gloves, both of which can be sterilized under UV light would go a long way towards protecting anyone from infection. These are just suggestions but we need more original and creative thinking to mitigate both the health and economic effects of this disease.

  12. 12
    Belfast says:

    Well, Ed, if you don’t get it, don’t take it. If your wife gets it, don’t let her take it, wait till yo and she are “advanced”
    It wasn’t off licence “for advanced cases only” as far as I read. Where did you get that from?

  13. 13
    Ed George says:


    EG, the not invented here syndrome practically reeks from what is being suggested.

    Sorry, I have no idea what you are suggesting here.

  14. 14
    JVL says:


    [Abstract] Objective: To evaluate the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of patients with common coronavirus disease-19 (COVID-19).

    Methods: We prospectively enrolled 30 treatment-naïve patients with confirmed COVID-19 after informed consent at Shanghai Public Health Clinical Center. The patients were randomized 1:1 to HCQ group and the control group. Patients in HCQ group were given HCQ 400 mg per day for 5 days plus conventional treatments, while those in the control group were given conventional treatment only. The primary endpoint was negative conversion rate of COVID-19 nucleic acid in respiratory pharyngeal swab on days 7 after randomization. This study has been approved by the ethics committee of Shanghai public health clinical center and registered online (NCT04261517).

    Results: One patient in HCQ group developed to severe during the treatment. On day 7, COVID-19 nucleic acid of throat swabs was negative in 13 (86.7%) cases in the HCQ group and 14 (93.3%) cases in the control group (P>0.05). The median duration from hospitalization to virus nucleic acid negative conservation was 4 (1-9) days in HCQ group, which is comparable to that in the control group [2 (1-4) days, (U = 83.5, P>0.05)]. The median time for body temperature normalization in HCQ group was 1 (0-2) after hospitalization, which was also comparable to that in the control group 1 (0-3). Radiological progression was shown on CT images in 5 cases (33.3%) of the HCQ group and 7 cases (46.7%) of the control group, and all patients showed improvement in follow-up examination. Four cases (26.7%) of the HCQ group and 3 cases (20%) of the control group had transient diarrhea and abnormal liver function (P> 0.05).

    Conclusions: The prognosis of common COVID-19 patients is good. Larger sample size study are needed to investigate the effects of HCQ in the treatment of COVID-19. Subsequent research should determine better endpoint and fully consider the feasibility of experiments such as sample size.

    ET: The only place it should be administered is under a doctor’s care. You should be in the hospital by that phase of the illness. Your lungs are filling with fluid and you can barely breath. Those are the people who are getting that treatment.

    It’s the “when all else has failed”, solution.

    I think that is correct. Sadly.

  15. 15
    vividbleau says:

    “We have a drug which is being touted by a president who is notorious as an habitual liar “

    This is rich one liar accusing another of committing the same offense.


  16. 16
    kairosfocus says:


    First, it seems that you have not noted the background, that Chloroquine has been known to have strong and fairly broad antiviral action against DNA and RNA viruses since the days of the SARS epidemic. Its ability to suppress undesirable things is so broad in fact that it was used as an aquarium cleaner since the early 1970’s. In addition, its known anti-inflammatory effects and zinc promotion were known to be relevant to dealing with viruses and deadly complications.

    Where, further, there are reports from its usage in the centre of emergence for the epidemic on its efficacy. Indeed, the paper from Cantonese physicians is regarding defining a standardised protocol for its use against Covid-19. This, in the context that Chinese physicians and researchers have been playing leading roles in addressing clinical and laboratory work on this epidemic. Dismissiveness to their work (and by extension similar work in Australia and France) comes across as not invented here red tape.

    Let me pause and clip again from my earlier post, from 15 years ago:

    Virology Journal
    2, Article number: 69 (2005)
    Research Open Access Published: 22 August 2005

    Chloroquine is a potent inhibitor of SARS coronavirus infection and spread

    Severe acute respiratory syndrome (SARS) is caused by a newly discovered coronavirus (SARS-CoV). No effective prophylactic or post-exposure therapy is currently available.
    We report, however, that chloroquine has strong antiviral effects on SARS-CoV infection of primate cells. These inhibitory effects are observed when the cells are treated with the drug either before or after exposure to the virus, suggesting both prophylactic and therapeutic advantage. In addition to the well-known functions of chloroquine such as elevations of endosomal pH, the drug appears to interfere with terminal glycosylation of the cellular receptor, angiotensin-converting enzyme 2. This may negatively influence the virus-receptor binding and abrogate the infection, with further ramifications by the elevation of vesicular pH, resulting in the inhibition of infection and spread of SARS CoV at clinically admissible concentrations. [–> Notice, mechanisms of action are on the table, c 2005]
    Chloroquine is effective in preventing the spread of SARS CoV in cell culture. Favorable inhibition of virus spread was observed when the cells were either treated with chloroquine prior to or after SARS CoV infection. In addition, the indirect immunofluorescence assay described herein represents a simple and rapid method for screening SARS-CoV antiviral compounds.

    Next, I remind from the earlier discussion:

    . . . Recently, the China National Center for Biotechnology Development indicated that chloroquine is one of the three drugs with a promising profile against the new SARS-CoV-2 coronavirus that causes COVID-19. Chloroquine repurposing was investigated in hospitals in Beijing, in central China’s Hunan Province and South China’s Guangdong Province. According to preliminary reports [50,51] from the Chinese authorities suggesting that approximately 100 infected patients treated with chloroquine experienced a more rapid decline in fever and improvement of lung computed tomography (CT) images and required a shorter time to recover compared with control groups, with no obvious serious adverse effects, the Chinese medical advisory board has suggested chloroquine inclusion in the SARS-CoV-2 treatment guidelines. [–> that’s a study on 100 patients, reinforcing both effectiveness and reasonablle safety, drugs being poisons in small doses] As a result, chloroquine is probably the first molecule to be used in China and abroad on the front line for the treatment of severe SARS-CoV-2 infections. [–> on the frontline]

    Where also, the same Sci Direct article noted:

    In vitro, chloroquine appears as a versatile bioactive agent reported to possess antiviral activity against RNA viruses as diverse as rabies virus [16], poliovirus [17], HIV [12,[18], [19], [20]], hepatitis A virus [21,22], hepatitis C virus [23], influenza A and B viruses [24], [25], [26], [27], influenza A H5N1 virus [28], Chikungunya virus [29], [30], [31], Dengue virus [32,33], Zika virus [34], Lassa virus [35], Hendra and Nipah viruses [36,37], Crimean–Congo hemorrhagic fever virus [38] and Ebola virus [39], as well as various DNA viruses such as hepatitis B virus [40] and herpes simplex virus [41].

    That’s broad antiviral action, in a drug that has long been studied so it was known that it could make the transition from in glass to in body. In a reasonable world, it should have long since been vigorously followed up as we know that antivirals are a challenge. The real question we should be asking is why it is that it wasn’t.

    And against that prior backdrop, the strength of current reports is multiplied. For, we are not dealing with something unfamiliar that was only on the table because some snake oil promoter is putting up some magical cure-all. No, we have a drug known since 1934, routinely used against Malaria until it became ineffective due to adaptation of those terrible parasites and used in several contexts because of anti-inflammatory properties discovered in the clinical setting (yes, “anecdotal”).

    So, why wasn’t it followed up long since and demonstrated to be ineffective [if so], or else characterised as a potential antiviral? I suspect, first, a market failure: it has long since become a generic, so it would be unprofitable for pharmaceutical companies to carry forward the hugely expensive, red tape riddled trials and certification process. I suspect also, a research failure, academics are generally interested in novelties not what is old hat.

    So, it is unsurprising, in the end, that it has taken the fierce pressure of a destructive pandemic to resurface Chloroquine as an antiviral and anti-immune over-reaction candidate. In that context, it is unsurprising that cocktails involving Zinc and z-pac [used against bronchial infections] would be found effective.

    Let me add in, Delingpole’s pointed remarks:

    It ought to be no surprise that chloroquine is effective against both SARS and COVID-19. After all, they are both coronaviruses and COVID-19 has often been described in medical and research sources as SARS-2.

    Chloroquine works by enabling the body’s cells better to absorb zinc, which is key in preventing viral RNA transcription – and disrupting the often fatal cytokine storm.

    As at least one person has noticed, the implications of this are enormous. If the medical establishment – including CDC – has been aware of the efficacy of chloroquine in treating coronavirus for at least 14 years, why has it not been mass produced and made available sooner?

    As he goes on:

    Here, you might have imagined, is the dream solution: a stop gap treatment for coronavirus which could save many lives and obviate the need for this global lockdown which is destroying our economies.

    Why isn’t the solution being shouted from the rooftops?

    One possibility, as I suggested yesterday, is that there is no money in it for Big Pharma. Chloroquine is a generic drug. That’s why Big Pharma’s lobbyists have worked hard to persuade governments that there can be no acceptable solution till a patented vaccine is brought on to the market. Even if this happens it won’t be till long after the pandemic is over – probably not till at least next year.

    I don’t think our businesses, our livelihoods, our sanity can wait that long. Do you?

    Of course, I don’t take as negative a view as Delingpole suggests. Our trials and approvals process has become overly expensive and cumbersome, thus slow moving and hugely costly. It obviously has little room for quick responses to pandemics and for fast-track experimental responses that can act in real time when, literally, days count. But in this context, precisely because chloroquine has longstanding approvals and known side effects etc, off label use by physicians who see a favourable balance of do what good can be done vs do no needless harm is a responsible approach.

    In that context, physician’s reports of effectiveness count as relevant evidence.

    So, at bottom, we are now dealing with inductive logic and linked ethics.

    Converging lines of empirical observation with repeated success, provision of mechanisms, demonstration of effectiveness on relevant issues [immune over-reaction], indications of reliable action, known manageability of toxic effects at relevant dosages all point to effectiveness and safety. Safety and effectiveness in the face of a pandemic point to the need for a fast track, experimental approvals process that runs in parallel with more formal investigations. Then, the wider do no harm issue comes in: triggering a deep recession in the face of a pandemic, to certainty, portends far wider harms including significant loss of life; which cannot be justified unless there is no credible alternative. To so needlessly trigger a massively ruinous process is manifest, large-scale injustice.

    So, in the end, there is a moral challenge and we are up against the inescapable first duties of reason: to truth, to right reason [including inductive logic!], to prudence [so, to warrant], to sound conscience [notice the physicians doing the best they can by their patients], to neighbour [what would we want in the face of a serious hazard to life, if one has preconditions . . . which is what Dr Zelensky is factoring in], to fairness and justice [as in, needless deep recession].

    It is clear that our drugs development process needs reform.


  17. 17
    Bob O'H says:

    kf – the NY doctor’s name is Zelenko, not Zelensky (Zelensky is the name of the Ukrainian president, the man who receives perfect phone calls).

    FWIW I would be very sceptical of Zelenko’s claims. Off the bat, he’s claiming to have about 20k cases. If you consider that the US as a whole has 65k confirmed cases, that’s a huge hotspot. He also claims a 100% success rate, but even the (small) trials that have been done don’t show that: in both cases people on treatment go worse and had to be moved to ventilators.

  18. 18
    bornagain77 says:

    Of related note: Chloroquine has a long history,

    Chloroquine, Past and Present – By Derek Lowe – 20 March, 2020
    Excerpt: Chloroquine’s fame is as an antimalarial drug, and the history of antimalarials starts of course with quinine (at right). That’s the active compound in cinchona bark, whose medicinal properties had long been known among the natives of South America in the tropical parts of the Andes – the Incas and the people(s) that the Incas absorbed into their empire. It doesn’t seem to have been used by them as a malaria treatment per se, but rather was known as a treatment for shivering, brought on by either low temperatures or by malaria itself. The Spanish conquerors introduced it into Europe in the 1600s. The study of cinchona bark and its extracts is a key part of the history of medicinal chemistry as a science – the pure compound was extracted in 1820 by Caventou and Pelletier, ,,,
    ,,, if you see someone confidently explaining just how chloroquine exerts whatever antiviral activity it may have, feel free to go read something else. No one’s sure yet. Viruses certainly have fewer moving parts than plasmodia do, so it might be easier to figure out what’s going on, but anyone who’s done “target ID” will tell you to settle in for some work.

    From the comment section:

    The side effects are modest for most, especially on a 10 days or less regimen.
    Approx. 5% or higher risk of NOT taking it when ill from coronavirus it is you could end up in ICU on a ventilator, on the other hand, the risk of taking it and getting serious side effects is minimal at about 1.5% in the study below.
    Google this title:
    Reported Side Effects to Chloroquine, Chloroquine
    plus Proguanil, and Mefloquine as Chemoprophylaxis
    against Malaria in Danish Travelers
    85% of Danish travelers reported no side effects
    minor side effects are:
    stomach pain (take only with a full meal)
    the depression / anxiety incident was ONE person – – we don’t base science on what happen to ONE person.
    severe side effects in only 1.5% of cases
    Only LONG TERM USE for many months or years can have retina involvement.

    And of course the study of the efficacy of chloroquine was a major part of Dr. Behe’s work in deducing what the ‘edge of evolution’ actually is, i.e. what the limits of what unguided evolutionary processes would reasonably be expected to accomplish, (which is not much at all)

    On Chloroquine Resistance, Nathan Lents Severely Misrepresents Behe’s Arguments – February 19, 2019
    On average, for humans to achieve a mutation like this by chance, we would need to wait a hundred million times ten million years. Since that is many times the age of the universe, it’s reasonable to conclude the following: No mutation that is of the same complexity as chloroquine resistance in malaria arose by Darwinian evolution in the line leading to humans in the past ten million years. (The Edge of Evolution, pp. 60-61),,,
    Behe never says that chloroquine resistance is too complex to evolve. As was explained previously, he observes that it does evolve and he cites public health data showing that it arises in approximately 1 in 1020 cells. The point is that while there are enough P. falciparum cells to produce this trait, a similarly rare trait could not arise in humans on a reasonable timescale because there are too few individuals (i.e., not enough trials).

    Guide of the Perplexed: A Quick Reprise of The Edge of Evolution – Michael Behe – August 20, 2014
    Excerpt: If there were a second drug with the efficacy of chloroquine which had always been administered in combination with it (but worked by a different mechanism), resistance to the combination would be expected to arise with a frequency in the neighborhood of 1 in 10^40 — a medical triumph.

  19. 19
    kairosfocus says:

    BO’H, thanks, I will correct. I note that his claims do not stand in isolation from a convergent global cluster of evidence, some of which has been pointed out above and in other threads. Where, all that is on the table ethically is a fast, quick and dirty track permission to use promising remedies based on proved reasonably safe drugs on a provisional basis in the face of a pandemic. It is unlikely indeed that the work in China, Australia, France etc all show strong positive results by chance or that some hitherto unknown devastating thalidomide like danger will emerge for a nearly 90 year old drug. Notice, it is known — and documented in the literature — to have antiviral effects for at least 15 years, including on this family of viruses. With reasonable causal mechanisms [there seem to be multiple effects] on the table. And of course fast track provisional use does not lock out the running of large scale trials such as Bayer and others donated towards and such as has been launched in NY as of Tue last. I think we need to be taking a serious look at how we regard inductive reasoning, warrant, first duties of responsible reason and the issue of moral certainty — that degree of warrant where it is irresponsible to act as though a claim or case X were false, on the cluster of evidence in hand that it is reasonably likely to be true. Where, we are in the obvious moral equivalent of a world war. KF

    PS: The doctor is NOT claiming to have 20 k cases. He is serving a Hasidic community of 36 k, and estimates on observation that likely 20 k have caught the virus, about 60 percent is his number, reasonable on the epidemiology. He claims to have treated several hundreds, which makes sense as he is likely a preferred physician for a tightly knit community and a sympathetic figure fighting what sounds like multiple cancers. He is of course one of his patients.

  20. 20
    ET says:

    The SCIENCE behind the use of these drugs to fight covid 19 is sound. That is why its detractors are so confused- they don’t understand science.

  21. 21
    kairosfocus says:

    F/N: A March article in the Oxford journal, Clinical Infectious Diseases:

    Accepted manuscript
    In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

    Xueting Yao, Fei Ye, Miao Zhang, Cheng Cui, Baoying Huang, Peihua Niu, Xu Liu, Li Zhao, Erdan Dong, Chunli Song, Siyan Zhan, Roujian Lu, Haiyan Li, Wenjie Tan, Dongyang Liu

    Clinical Infectious Diseases, ciaa237,
    09 March 2020


    The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) first broke out in Wuhan (China) and subsequently spread worldwide. Chloroquine has been sporadically used in treating SARS-CoV-2 infection. Hydroxychloroquine shares the same mechanism of action as chloroquine, but its more tolerable safety profile makes it the preferred drug to treat malaria and autoimmune conditions. We propose that the immunomodulatory effect of hydroxychloroquine also may be useful in controlling the cytokine storm that occurs late-phase in critically ill SARS-CoV-2 infected patients. Currently, there is no evidence to support the use of hydroxychloroquine in SARS-CoV-2 infection. [–> this is a case of, in parallel developments gloally]

    The pharmacological activity of chloroquine and hydroxychloroquine was tested using SARS-CoV-2 infected Vero cells. Physiologically-based pharmacokinetic models (PBPK) were implemented for both drugs separately by integrating their in vitro data. Using the PBPK models, hydroxychloroquine concentrations in lung fluid were simulated under 5 different dosing regimens to explore the most effective regimen whilst considering the drug’s safety profile.

    Hydroxychloroquine (EC50=0.72 ?M) was found to be more potent than chloroquine (EC50=5.47 ?M) in vitro. Based on PBPK models results, a loading dose of 400 mg twice daily of hydroxychloroquine sulfate given orally, followed by a maintenance dose of 200 mg given twice daily for 4 days is recommended for SARS-CoV-2 infection, as it reached three times the potency of chloroquine phosphate when given 500 mg twice daily 5 days in advance.

    Hydroxychloroquine was found to be more potent than chloroquine to inhibit SARS-CoV-2 in vitro.
    Chloroquine, Hydroxychloroquine, SARS-CoV-2

    chloroquine hydroxychloroquine antiviral agents sars-cov-2

    Issue Section:
    Major Article

    Further demonstration of the chemical effectiveness, here the hydro form.

    Recall, it is long since known to transfer effectively into the body and to have reasonably manageable toxic effects.


  22. 22
    kairosfocus says:

    F/N: Notice, by March 11:

    New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19?
    Sciprofile linkChristian A. Devaux, Jean-Marc Rolain, Philippe Colson, Didier Raoult
    Published: 11 March 2020
    by Elsevier BV
    in International Journal of Antimicrobial Agents
    International Journal of Antimicrobial Agents ; doi:10.1016/j.ijantimicag.2020.105938

    Abstract: Recently, a novel coronavirus (2019-nCoV), officially known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in China. Despite drastic containment measures, the spread of this virus is ongoing. SARS-CoV-2 is the aetiological agent of coronavirus disease 2019 (COVID-19) characterised by pulmonary infection in humans. The efforts of international health authorities have since focused on rapid diagnosis and isolation of patients as well as the search for therapies able to counter the most severe effects of the disease. In the absence of a known efficient therapy and because of the situation of a public-health emergency, it made sense to investigate the possible effect of chloroquine/hydroxychloroquine against SARS-CoV-2 since this molecule was previously described as a potent inhibitor of most coronaviruses, including SARS-CoV-1. Preliminary trials of chloroquine repurposing in the treatment of COVID-19 in China have been encouraging, leading to several new trials. Here we discuss the possible mechanisms of chloroquine interference with the SARS-CoV-2 replication cycle . . . .

    Hydroxychloroquine has pharmacokinetics similar to that of chloroquine, with rapid gastrointestinal absorption and renal elimination. However, the clinical indications and toxic doses of these drugs slightly differ . . . .

    Chloroquine is also utilised in the treatment of autoimmune diseases [6]. Yet the activity of the molecule is not limited to malaria and the control of inflammatory processes, as illustrated by its broad-spectrum activity against a range of bacterial, fungal and viral infections [7–10]. Indeed, in the mid-1990s, due to its tolerability, rare toxicity reports, inexpensive cost and immunomodulatory properties [11], chloroquine repurposing was explored against human immunodeficiency virus (HIV) and other viruses associated with inflammation and was found to be efficient in inhibiting their replication cycle [12] . . . .

    Despite drastic containment measures, the spread of [the emergent] 2019-nCoV, now officially known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [–> notice, the SARS2], is ongoing. Phylogenetic analysis of this virus indicated that it is different (~80% nucleotide identity) but related to SARS-CoV-1 [15]. Because the world is threatened by the possibility of a SARS-CoV-2 pandemic, the broad-spectrum antiviral effects of chloroquine warranted particular attention for repurposing this drug in the therapy of the disease caused by SARS-CoV-2, named coronavirus disease 2019 (COVID-19) . . . .

    Chloroquine has multiple mechanisms of action that may differ according to the pathogen studied.
    Chloroquine can inhibit a pre-entry step of the viral cycle by interfering with viral particles binding to their cellular cell surface receptor. Chloroquine was shown to inhibit quinone reductase 2 [56], a structural neighbour of UDP-N-acetylglucosamine 2-epimerases [57] that are involved in the biosynthesis of sialic acids. The sialic acids are acidic monosaccharides found at the extremity of sugar chains present on cell transmembrane proteins and are critical components of ligand recognition. The possible interference of chloroquine with sialic acid biosynthesis could account for the broad antiviral spectrum of that drug since viruses such as the human coronavirus HCoV-O43 and the orthomyxoviruses use sialic acid moieties as receptors [58]. The potent anti-SARS-CoV-1 effects of chloroquine in vitro were considered attributable to a deficit in the glycosylation of a virus cell surface receptor, the angiotensin-converting enzyme 2 (ACE2) on Vero cells [59] . . . .

    Chloroquine can also impair another early stage of virus replication by interfering with the pH-dependent endosome-mediated viral entry of enveloped viruses such as Dengue virus or Chikungunya virus [60,61]. Due to the alkalisation of endosomes, chloroquine was an effective in vitro treatment against Chikungunya virus when added to Vero cells prior to virus exposure [30]. The mechanism of inhibition likely involved the prevention of endocytosis and/or rapid elevation of the endosomal pH and abrogation of virus–endosome fusion. A pH-dependant mechanism of entry of coronavirus into target cells was also reported for SARS-CoV-1 after binding of the DC-SIGN receptor [62]. The activation step that occurs in endosomes at acidic pH results in fusion of the viral and endosomal membranes leading to the release of the viral SARS-CoV-1 genome into the cytosol [63]. In the absence of antiviral drug, the virus is targeted to the lysosomal compartment where the low pH, along with the action of enzymes, disrupts the viral particle, thus liberating the infectious nucleic acid and, in several cases, enzymes necessary for its replication [64]. Chloroquine-mediated inhibition of hepatitis A virus was found to be associated with uncoating, thus blocking its entire replication cycle [22].

    Chloroquine can also interfere with the post-translational modification of viral
    proteins . . . [and more]

    We are clearly not dealing with snake oil claims here.

    We are seeing clinical indications that the known chemical effectiveness is credibly translating into reasonable effects on patients, with more or less plausible candidate mechanisms that suggest multiple effects. We are also able to translate from the chemical test concentrations to reasonable, safe-level therapeutic dosages.

    So, we are looking at the issue of moral certainty relative to exploratory, fast track provisional use in parallel with further formal investigations.

    In this context, selectively hyperskeptical dismissal and strawman targetting of a despised political figure are inappropriate responses. Too much is on the table, lives, to play politics with inductive warrant and ethics of potentially life saving action with manageable risk. Likewise, with the implications — including loss of life — attendant on throwing the world into deep recession.

    It is time to reconsider the political rhetoric and bureaucratic red tape games.


  23. 23
    kairosfocus says:

    ET, it seems the problem is inductive, scientific warrant, economic issues, ethics and moral certainty. A familiar, notorious cluster of challenges from the design and climate change controversies. KF

  24. 24
    Seversky says:

    I see James Dyson – the vacuum cleaner guy – has designed a new form of ventilator in just 10 days and is planning to manufacture 15,000 of them. That’s the kind of enterprising materialism we need.

  25. 25
    ET says:

    Capitalism, not materialism.

  26. 26
    ET says:


    I think that is correct. Sadly.

    Sadly? Clearly you have no clue about this treatment.

  27. 27
    bornagain77 says:

    Only would Seversky try to claim that Intelligently repurposing vacuum cleaner assembly into ventilator assembly in just 10 days, and then ‘planning’ to manufacture 15,000 of them, was ‘enterprising materialism’.

    Tell me Seversky, just where did your mindless, purposeless, ‘enterprising materialism’ come into play in this entirely intelligently designed endeavor?

    He had a goal in mind and he purposely rearranged parts of his factory to achieve that goal in as short an order as possible!

  28. 28

    Dear BornAgain

    Nail meet hammer.
    That was great.
    Your short rebuttals are splendid.

  29. 29
    ET says:

    Chloroquine therapies work because they increase the lysosomal Ph which causes the ACE2 receptor to change shape just enough to prevent the covid-19 virus from binding to it. So what we need to focus on is how to increase our own body’s Ph naturally. And this has already been studied and written about. We just need to read about it and follow the instructions.

  30. 30
    kairosfocus says:

    F/N: I see the now increasingly common censorship has taken out the statement by the good doctor from upstate NY. Why am I not surprised? KF

  31. 31
    kairosfocus says:

    ET, actually, it seems there are multiple possible mechanisms of action; which if so points to robustness of effectiveness through a degree of redundancy. Out there, there is a comment that if you see anybody propose just one as definitive, turn the page [as that implies gaps in understanding] KF

  32. 32
    ET says:

    Yes, a combination of ACE2 inhibitors along with Ph raising foods and supplements. Or better yet an inhaler that denatures the protein spikes on the virus.

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