The world’s physicians weigh in — they want Hydroxychloroquine and Azithromycin

F/N: I cross-post from the current Zelenko thread, as notable: >>F/N: Dr Mehmet Oz on with Lou Dobbs: Didier Raoult has initial results on his first 1,000 patients, 7 deaths, 20 to ICU, observes "a case series of 1,000 patients is not anecdotal." He notes that NY Gov Cuomo's ruling locked down his outpatient study, parallel to Raoult. A transcript of a key part:

Dr. Oz: Well the trial that I was helping with at my institution was shut down when the governor banned the use of hydroxychloroquine for prescription use for outpatients. And I was trying to see if it could prevent, well there was a prevention trial that was approved, but I was trying to see if it could actually treat early disease and replicate what has been done in China and in France. Unfortunately, those trials have been held back. I don’t know of a trial in New York State. I have been searching for the one that has been spoken about… I spoke this morning to the famous French Infectious Disease specialist Didier Raoult, he’s the one who’s actually been pioneering the hydroxychloroquine with azithromycin, it’s not published yet, but he shared the results of his first thousand patients who have been on that protocol. Seven people died. They were all older and frail individuals. That is lower than what you would expect from people who have been admitted to the hospital. And he’s had 20 got to the ICU, again lower than I would expect… Well, I’m upset because I wanted to do the trial. Also I wanted it to be legal in my state for a doctor to talk to a patient about the COVID-19 and treat them as they saw appropriate.

Something very wrong is going on at governance and policymaking level. He is also calling for someone with Lupus on HCQ with CV19 to come forward, in concert with a support group. So far, he has not had anyone. He also reports the colleague who heads the Lupus Society and others in that world of practice see fears over side effects as punched up, i/l/o their collective experience. This holds for heart effects and he says eye effects show up after five years of chronic use. Another straw in the wind.>> KF kairosfocus

There is another Zelenko video https://www.youtube.com/watch?time_continue=400&v=Z7SDemHGl8U&feature=emb_logo I haven't seen it all but it essentially says the same thing as before. jerry

JAD, The usual thought is, Z-Pac addresses secondary infection, typically bacterial. HCQ has several suggested mechanisms, which may be working in parallel. Which would be good. KF kairosfocus

One of the problems with using hydroxychloroquine (HCQ) and azithromycin as a COVID-19 therapeutic is scientifically explaining how and why it works. On the other hand, one LA doctor has been prescribing and HCQ with zinc, rather than azithromycin. Why? It’s not just because he has been having very promising results but because he can, at least tentatively, explain scientifically why it works.

Dr. Anthony Cardillo said he has seen very promising results when prescribing hydroxychloroquine in combination with zinc for the most severely-ill COVID-19 patients. "Every patient I've prescribed it to has been very, very ill and within 8 to 12 hours, they were basically symptom-free," Cardillo told Eyewitness News. "So clinically I am seeing a resolution." Cardillo is the CEO of Mend Urgent Care, which has locations in Sherman Oaks, Van Nuys and Burbank. He said he has found it only works if combined with zinc. The drug, he said, opens a channel for the zinc to enter the cell and block virus replication.

https://abc7news.com/coronavirus-drug-covid-19-malaria-hydroxychloroquine/6079864/ Do any of the researchers investigating hydroxychloroquine and azithromycin have a hypothesis why it works? If they do I have been unable to find it. To gain broader acceptance it would be good to have a scientifically sound explanation. Maybe we need a clinical trial comparing HCQ + azithromycin vs. HCQ + zinc. john_a_designer

Here is an American doctor who has had some success in in treating patients with COVId-19 with hydroxychloroquine and azithromycin.

Dr. Stephen Smith, founder of The Smith Center for Infectious Diseases and Urban Health, said on “The Ingraham Angle” on Wednesday night that he is optimistic about the use of antimalarial medications and antibiotics to treat COVID-19 patients, calling it “a game-changer.” “I think this is the beginning of the end of the pandemic. I’m very serious,” Smith, an infectious disease specialist, told host Laura Ingraham. Currently there is no known cure for the coronavirus pandemic ravaging the globe. Smith, who is treating 72 COVID-19 patients, said that he has been treating "everybody with hydroxychloroquine and azithromycin [an antibiotic]. We’ve been doing so for a while.” He pointed out that not a single COVID-19 patient of his that has been on the hydroxychloroquine and azithromycin regimen for five days or more has had to be intubated. “The chance of that occurring by chance, according to my sons Leon and Hunter who did some stats for me, are .000-something,” he said, adding that “it’s ridiculously low." Smith explained that “intubation means actually putting a tube down into your trachea and then you’re placed on the ventilator for respiratory support.”

https://www.foxnews.com/media/dr-stephen-smith-on-effectiveness-of-hydroxychloroquine-with-coronavirus-symptoms-beginning-of-the-end-of-the-pandemic It appears to me that he is recommending that the treatment begin early. At least as soon as their symptoms appear to become serious. john_a_designer

BR, that annual toll speaks to our need for better antivirals and a new generation of antibiotics. KF kairosfocus

What I want is an end to the economic rebellion that has been taking place in the United States. No state can put an undue burden on interstate commerce without violating the Commerce Clause. There is nothing in the Constitution to allow the actions under any circumstances. Unlike COVID-19, which is a coronavirus, influenza does not need certain conditions to be met in order to be lethal. Are we to shut down the global economy every time flu season comes around? Influenza kills 500,000 people every year on average. BobRyan

@KF Don’t misunderstand me, I appreciate what you’re doing and I applaud what you are doing. I was trying to tell you to brace yourself for the ignorant comments of people like Seversky and asking that they don’t let them deter you, or tear your hair it at their inane parroting and their pretence of caution to cover their TDR. BTW I was on to Hqc and zinc after reading an article in an engineering blog, of all places, even before Dr Zelensky came on the scene., or Raoult. Belfast

Sev, I should add to TF, that the couple only became poisoning patients because they ignored warning labels on fish tank cleaner and common sense then consumed a teaspoonful apiece, such never having been recommended by anyone, and certainly not Mr Trump. The attempt to taint Mr Trump with guilt by association in sections of the media was grossly irresponsible AND required omitting a cluster of fairly accessible facts from across the world including the FDA's compassionate and emergency use approval of March 19. Likewise, it seems reasonable to observe that while arthritis is a long term complaint we are here dealing with a disease that has a track record of killing within days. More can be taken up later KF PS: As a reminder, I again clip a report from mid-Feb, in Clinical Trials Arena, February 18th::

Coronavirus: Chloroquine yields positive data in Covid-19 trial Early data from clinical trials being performed in China has revealed that chloroquine phosphate could help treat the new coronavirus disease, Covid-19. China National Center for Biotechnology Development deputy head Sun Yanrong said that chloroquine, an anti-malarial medication, was selected after several screening rounds of thousands of existing drugs. Xinhua reported that the drug is undergoing clinical trials in more than ten hospitals in Beijing, Guangdong province, and Hunan province . . . . Data from the drug’s studies showed ‘certain curative effect’ with ‘fairly good efficacy’. According to Sun, patients treated with chloroquine demonstrated a better drop in fever, improvement of lung CT images, and required a shorter time to recover compared to parallel groups. [Thus, there were controls with different treatment patterns] The percentage of patients with negative viral nucleic acid tests was also higher with the anti-malarial drug. Chloroquine has so far showed no obvious serious adverse reactions in the more than 100 participants in the trials. The China National Center for Biotechnology Development head Zhang Xinmin said that chloroquine is one of the three drugs that have a promising profile against the new coronavirus, reported China Daily. The remaining two drugs are anti-flu medicine favipiravir and Gilead’s investigational anti-viral candidate remdesivir . . .

Also, a Pharmacy Times report on the March 19 initial approval by FDA, yes, a month later:

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 [Notice, Hahn] 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. [--> not by dipping into one's stash of fish tank cleaner] 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. REFERENCES 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.

Both of these are taken from earlier OP's in our coverage here at UD. kairosfocus

@5 Seversky

... and at least 1 death reported in a patient who drank fish tank cleaner because of its CQ content.

So because an imbecile drank fish tank cleaner and died therefore CQ is not effective and is dangerous? Massive non-sequitur here. What does this have to do with science? Truthfreedom

Polistra, would it surprise you to learn the US media viewed it as promising until about the time Mr Trump supported it as promising the day after the FDA approved it for compassionate and emergency use? It seems to me the physicians took the studies in China etc and reports of positive results seriously and are likely seeing at least some of what Dr Zelenko and Dr Raoult have seen. KF kairosfocus

Seversky, just the most recent Raoult studies should be more than sufficient to show that it is vanishingly unlikely that the HCQ-Z-Pac cocktail worked or seemed to work in these cases by chance. Say, 1/10 of the time something like this would work by chance if given in adequate time. The odds it worked like this 79 times in a test run are vanishingly small. Take the 38% of the time placebo yardstick and apply the same, and there is no material difference. We have several potential mechanisms, and it is possible that multiple actions happen. Then factor in his and other chemical tests. These show that in reasonable concentrations in reasonable tissue contexts, the chemical and/or the cocktail should work. There is a reason why, a week ago, after the second tests, France approved the drug and the US moved up the approvals ladder. Pharmaceutical companies are putting their money on the drug and expect to produce 250 million tablets by mid month. The views and actions of the physicians on the front lines around the world make good sense. The underlying epistemological and decision theory issue is that we need to move away from a hyperskepticism model to balanced prudence. KF kairosfocus

whose efficacy is supported at present by weak evidence and anecdotal claims

100% success by a US doctor. Support for the approach based on past research on two US medical sites for medical practitioners. Use by South Korea to ameliorate their infections. My guess if anyone is affected, they would be at the head of the line demanding this treatment. No one is suggesting not doing something else. But until a better solution comes down the pike, don't suggest holding back because the information is not perfect. jerry

There is no doubt that in the case of COVID-19 we all want the same thing - an effective treatment. But that end is not best served by fastening on a couple of drugs whose efficacy is supported at present by weak evidence and anecdotal claims. I hope hydrochloroquine and azithromycin prove to be as effective as they are claimed to be - "prove" being the operative word. But it would be a tragedy if the furore surrounding these two agents were to distract attention and scarce resources from the search for other, perhaps better, treatments. A more balanced and measured approach is perhaps better:

In the desperate search to find effective treatments for coronavirus disease 2019 (COVID-19), 2 generic drugs, used largely by rheumatologists and dermatologists to treat immune-mediated diseases, have entered the spotlight. The antimalarials hydroxychloroquine (HCQ) and chloroquine (CQ) have demonstrated antiviral activity against severe acute respiratory syndrome–coronavirus 2 (SARS–CoV-2) in vitro and in small, poorly controlled or uncontrolled clinical studies (1–3). Normally, such research would be deemed hypothesis-generating at best. A tweet by President Trump on 21 March 2020 claiming that the combination of HCQ and azithromycin “ha[s] a real chance to be one of the biggest game changers in the history of medicine” accelerated a worldwide run on the drugs, with pharmacies reporting shortages within 24 hours. Here, we try to provide guidance regarding clinical decision making both for patients with COVID-19 and those with immune-mediated conditions, such as systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), and strategies to mitigate further harm to these patients. Data to support the use of HCQ and CQ for COVID-19 are limited and inconclusive. The drugs have some in vitro activity against several viruses, including coronaviruses and influenza, but previous randomized trials in patients with influenza have been negative (4, 5). In COVID-19, one small nonrandomized study from France (3) (discussed elsewhere in Annals of Internal Medicine [6]) demonstrated benefit but had serious methodological flaws, and a follow-up study still lacked a control group. Yet, another very small, randomized study from China in patients with mild to moderate COVID-19 found no difference in recovery rates (7). Sadly, reports of adverse events have increased, with several countries reporting poisonings and at least 1 death reported in a patient who drank fish tank cleaner because of its CQ content. Antimalarial drugs can cause ventricular arrhythmias, QT prolongation, and other cardiac toxicity, which may pose particular risk to critically ill persons. Given these serious potential adverse effects, the hasty and inappropriate interpretation of the literature by public leaders has potential to do serious harm. At this time of crisis, it is our ethical obligation as physicians and researchers to organize and refer patients to expedited, well-performed randomized trials that can clarify if, when, and for whom antimalarial medications are helpful in COVID-19. As of this writing, 10 such trials are under way, and information should be forthcoming within weeks. Whereas the evidence supporting the use of antimalarial medications for COVID-19 is equivocal, the evidence for the use of these drugs to treat immune-mediated diseases is not. For example, HCQ is a cornerstone of therapy for SLE. Hydroxychloroquine can effectively treat disease manifestations, such as joint pain and rashes; reduce thrombotic events; and prolong survival. Of note, landmark clinical trials have demonstrated that the withdrawal of HCQ can lead to flares of disease, including life-threatening manifestations, such as lupus nephritis (8). The current shortages of HCQ have therefore alarmed rheumatologists and patients. Offices across the country report fielding calls from concerned patients who are having difficulty obtaining their medication. Given the likelihood that shortages will continue in the near term, we propose that manufacturers, clinicians, pharmacies, health systems, and governmental health agencies continue to coordinate an aggressive response to ensure that antimalarial drug use is appropriately managed during the COVID-19 pandemic. First, it is important to prioritize available supply for clinical trials evaluating important questions, such as dosing, prophylaxis, and treatment in COVID-19. Second, treatment interruptions for those with SLE and other rheumatic diseases must be prevented, because lapses in therapy can result in disease flares and strain already stretched health care resources. Third, stakeholders should work together to see whether dispensation of remaining supply to patients with COVID-19 makes sense as evidence rapidly changes. Fourth, clear messages that reflect the proper interpretations of available data must be disseminated with high frequency to counteract misinformation, including misleading statements or articles with “clickbait” material.

There is also the issue of collateral damage to patients suffering from other disorders who may find their proven drugs are no longer available because they are being diverted to unproven prophylactic treatment of COVID-19.

The looming public health crisis for people with rheumatic diseases who will be unable to obtain HCQ is the result of a perfect storm of fear and dissemination of overpromised data. However, there is still time to mitigate the damage. Physicians should educate themselves about the strength of available data regarding HCQ and CQ in treating COVID-19. They should avoid misuse of HCQ and CQ for the prophylaxis of COVID-19, because there are absolutely no data to support this. Public figures should refrain from promoting unproven therapies to the public, and instead provide clear messages around the uncertainties we face in testing and using experimental treatments during the current pandemic, including the risk for serious adverse events. Well-done, randomized clinical trials should be performed urgently to test potential therapies, including HCQ. In the meantime, physicians should remember that first, we must do no harm to the patients with rheumatic disease for whom high-quality evidence shows that HCQ improves health.

Seversky

Interesting. While everyone else turns chloroquine into a political football and asks whether we should START using it, doctors have BEEN using it all along. polistra

Belfast, the first duty of reason is to truth, thus also to right reason and prudence (which involves warrant) as close corollaries. If in the midst of a life threatening, up to recently exponentially growing pandemic is stereotyping, scapegoating and attacks to the man, that speaks tellingly. As it is, this live case is a study in cumulative warrant, the challenge of how crooked yardsticks warp judgement, how selective hyperskepticism fails, and how we must learn to judge and balance inductive cases in light of evidence, risks, values and duties. Where, good or bad intellectual habits are just that, habits. This case study demonstrates that serious rethinking and reform are indicated. Not, that that was not already evident on the design debates and many other clashes. If the despicable heretics keep getting things right, what does that say? Which, BTW, was precisely the question I asked myself about the Austrians in Economics. As a result of which, I have found Garrison's approach to Macro very useful as a complement and balance to other schools of thought. Whichever way we look at it on this matter we are tickling a dragon's tail. That's why Zelenko's battlefield medicine approach is so telling, especially on the decision that risks to benefits led to rapid deployment of Penicillin. We have some serious rethinking to do. KF PS: The myth that Mr Trump fiddled while the pandemic conflagration brewed needs to be corrected. This summary on where experts were on record -- as opposed to, in the dominant, media trumpeted narrative -- in January (time of the ill-advised, star chamber tactic impeachment) is telling: https://www.realclearpolitics.com/articles/2020/04/03/virus_experts_early_statements_belie_prescient_portrayal_142845.html kairosfocus

I appreciate what you are doing here but I fear from reading the comments made in the past that simply,because you and president Trump see hope in this drug, it is being classified as a Republican or an intelligent design drug, and therefore to be mocked or subjected to chin-pulling sage advice to wait until large scale testing is done and 50% of patients were offered the placebo. Going back 3000 years there was a Latin saying Tabula in Naufragio which essentially translates as any plank in a storm. No one in their right mind who tests positive would refuse to take HCQ, no one in their right mind would take a chance on a placebo. Belfast

The world’s physicians weigh in — they want Hydroxychloroquine and Azithromycin kairosfocus