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:
FDA Announces Two Drugs Given ‘Compassionate Use’ Status in Treating COVID-19
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. https://www.fda.gov/news-events/public-health-focus/expanded-access Updated May 6, 2019. Accessed March 19, 2020.
Bulloch M. Potential Pipeline Medications May Help Patients with Novel Coronavirus. Pharmacy Times. https://www.pharmacytimes.com/news/potential-pipeline-medications-for-the-coronavirus 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. https://www.gilead.com/purpose/advancing-global-health/covid-19 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:
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”
Hydrochloroquine wars, 2: a NY physician speaks of “hundreds” of successful patients, a Governor bans use in Nevada
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.
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
F/N: Here is a Townhall report on an interview with the renowned Dr Fauci:
That sounds a lot like a conversational version of the FDA position of March 19 reported in the OP above.
BA77, looks like you caught it too. KF
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.
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.
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
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.
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?
Sorry, I have no idea what you are suggesting here.
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.
“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.
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:
Next, I remind from the earlier discussion:
Where also, the same Sci Direct article noted:
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:
As he goes on:
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.
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.
Of related note: Chloroquine has a long history,
From the comment section:
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)
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.
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.
F/N: A March article in the Oxford journal, Clinical Infectious Diseases:
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.
F/N: Notice, by March 11:
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.
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
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.
Capitalism, not materialism.
Sadly? Clearly you have no clue about this treatment.
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!
Nail meet hammer.
That was great.
Your short rebuttals are splendid.
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.
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
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
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.