Doctor Ivette Lozano from Dallas, Texas on treating patients with HCQ Cocktails

_{kairosfocus
May 18, 2020

Defending our Civilization, Medicine, News Highlights, rhetoric, Sci-Tech watch

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Defending our Civilization
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Inimitable:

https://youtu.be/coyfWpwxedQ

Food for thought.

U/D: When it reaches the pharmacy . . .

U/D May 19, another Lozano interview:

And, oh yes, breaking 1: Mr Trump is praising — yes, I am NOT using, “touting” — a promising vaccination. Announcement by the firm, here.

Breaking, no 2, courtesy Daily Mail as usual:

Of course, the now standard, it’s risky is in the subheads.

U/D: Video:

Compare our Texas Doctor’s remarks. And then, there is the latest from Dr Raoult:

Whose report do you believe, why? END

Comments

kf @ 128 -
BO’H, you are falling into selective hyperskepticism, gold standard evidence form. Accordingly, I draw your attention to the following, as has been pointed out since 56.
Yes, and as I pointed out @ 70 they are calling for high-quality case-control studies, and these have been done, and show no effect. The study RHampton7 points out @132 is also precisely the sort of study that's being asked for in the piece you keep on linking to. Why do you keep on linking to an article asking for high-quality retrospective studies as a counter-argument to high-quality retrospective studies? It makes no sense.Bob O'H_{May 22, 2020
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RH7, Jerry is pointing out the stitch in time issue. By the time people are admitted to hospital under pandemic conditions, the virus has already multiplied and wreaked havoc, with complications coming along for the ride. Something that has been on the table for months now, and has enough telling force that the FDA is now visibly backing down. Lancet and others need to pay heed to linked questions of prudence and especially the need for timely, ethically sound and credibly effective treatment, where deliberately mislabelled sugar pills given to vulnerable people fighting a fast moving killer disease in the name of an alleged gold standard testing method cannot be excused; but then, the value of life has been severely eroded through decades of the worst holocaust in history -- 800+ million of our living posterity killed in the womb, at a rate now a little under a million per week. To enable which, key institutions have been corrupted under false colour of laws, etc. Frankly, all of this is beginning to sound like macroeconomics and linked policy debates in the 70's - 80's. It took a lot of time for the polarisation to settle out enough for things to be clear, and as usual vulnerable people paid the price. KF PS: You are still evading the force of the point put on the table by the folks from Harvard's Kennedy School:
Observe:
Unleash the Data on COVID-19 By Maryaline Catillon and Richard Zeckhauser* Given the lethality of the COVID-19 pandemic, the urgent need is for actionable information directing care towards treatments offering higher probabilities of improving outcomes and preventing death. In normal times, randomized control trials (RCTs) would be the gold standard for determining whether innovative medical treatments are safe and effective. But with 1,500 Americans dying every day, these are hardly normal times. There is an urgent need for high quality studies based on real world experience, which has already accumulated for many thousands of patients. Dr. Anthony Fauci, the nation’s pandemic physician in chief, said that RCT results will not be available "for months". The disease will not wait. RCTs, which randomly assign patients to a treatment or a control group, are only ethically acceptable when the safety and performance of a treatment is unknown. When ample data exists, as now, that criterion is not met. Analyzing real world data on actual outcomes, when it exists in abundance, offers an alternative approach to learn almost immediately. Moreover, it avoids the ethical challenge of an RCT, given that available data could predict outcomes. Massive numbers of COVID-19 patients are currently being administered "unproven" drugs based on medical decisions made by doctors. Massive numbers are not receiving any such drugs. Thus, carefully designed case control studies could leverage differences between ongoing protocols at large hospital systems and detailed information from patients’ electronic medical records. That could determine whether widely employed hydroxychloroquine, with or without azithromycin, provides significant benefits, and at which stages to which patients, and could provide similar information on the risks it imposes. It could yield the same information about remdesivir, and about many other drug treatments currently in use. [--> sounds familiar? That's been a line of argument I have pointed to for weeks] For each patient, doctors strive to optimize treatment in the current, uncertain environment. These drug versus non-drug decisions constitute an ongoing large observational study, in which the allocation to treatment and control groups varies widely. The large numbers of patients treated eliminates concerns that random variation might lead to misleading results. Those large numbers also yield results by demographic, comorbidities, and stage of disease. Leveraging real world evidence is more acceptable ethically when extensive information is already available. As decision theorists who have studied the methodological quality of vast numbers of RCTs, we are enthusiasts for well-conducted RCTs. But delaying public health recommendations till RCTs are completed is not appropriate in the present circumstance. Imminent threats are enormous and widespread data is easily at hand. The outcomes of the thousands of individuals who have already received drug therapies on an ad hoc basis should inform practice now . . . . High quality case control studies based on thousands of cases, the silver standard we recommend, are immensely faster than RCTs. Recent articles in the world’s leading medical journals show that they consistently yield the same major findings. Experience with the recommendations of antiretroviral therapy (ART) for HIV provides an instructive warning. Even though 20 years of observational studies demonstrated its enormous benefits, the World Health Organization waited until 2015 and the publication of the first set of RCT results (which reached the same conclusions) to make a "treat all" recommendation. Many lives were lost as the world waited for its recommendation. COVID-19 presents its own example. Through late March, medical authorities recommended the general public not employ masks to protect against it. In early April, that all switched: masks became strongly recommended. No RCT supported this reversal; little evidence was mounted. Yet officials applauded, the public widely complied, and the world was better off.
Well conducted includes ethical criteria. Of course. But such is obviously at a discount today. And notice the by now familiar context: decision theory.
kairosfocus_{May 22, 2020
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Jerry, the study was posted on Lancet, so it’s not fake. You’re right that it is not as accurate as definitive as an RCT. That’s why RCTs need to be done. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltextrhampton7_{May 22, 2020
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Very few rigorous trials of the drug have reported data. Some people were given the drug in studies in which there wasn’t a control group that got placebos, and results from some of those studies have been mixed, with some reporting benefits, others showing no effect, and some indicating that the drugs may even be harmful for some patients. Even the latest data from the large multinational study in the Lancet combined studies that used the drugs in different doses and in different ways that may not be directly comparable. Early evidence from tests of the drug points to hydroxychloroquine having no effect in combatting the disease in seriously ill patients (SN: 4/21/20). The large Lancet study also failed to show any benefit. But just because the drug didn’t seem to help in late stages of the disease, that doesn’t mean it won’t be effective if given early, perhaps even before people are exposed to the virus, Avidan says. That’s exactly what researchers are attempting in multiple trials testing the drugs effectiveness as a preventative, or prophylactic, treatment for the coronavirus. Some of those trials are just wrapping up — including two trials at the University of Minnesota — but aren’t reporting results yet. Others are still under way. https://www.sciencenews.org/article/coronavirus-covid-19-politics-hydroxychloroquine-treatment-researchrhampton7_{May 22, 2020
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More fake news by Rhampton. It's a hospital study. And no mention of zinc.jerry_{May 22, 2020
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The new study, led by investigators at Brigham and Women's Hospital Center in Boston, included data from 671 hospitals on six continents. Researchers compared the outcomes of nearly 15,000 COVID-19 patients received the drug or a similar compound, chloroquine, plus an antibiotic with those of about 81,000 COVID-19 patients who had not received the drugs. It was an observational study, meaning patients were not randomized to get a particular drug or a placebo. “ We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with" an antibiotic, the study authors wrote. What's more, the patients who got the drugs were more likely than the others to die in the hospital. The study authors called for high-quality, randomized clinical trials to confirm any harms or benefits of the medication. "In the meantime, we suggest these drugs should not be used as treatments for COVID-19 outside of clinical trials," Dr. Mandeep Mehra, lead author of the study and the executive director of the Brigham and Women's Hospital Center for Advanced Heart Disease in Boston, said in a statement. https://www.nbcnews.com/health/health-news/another-large-study-finds-no-benefit-hydroxychloroquine-covid-19-n1212886rhampton7_{May 22, 2020
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EG,if you had followed carefully, "in hospital . . ." would be a clue to the stitch in time . . . NOT . . . factor. The repeated attempt to drown out accumulating evidence is itself sending a message. KF PS: Meanwhile, here yet again is what is highly material and ever so tellingly studiously ignored . . . something that would still be material even were HCQ cocktails the sort of dangerous and ineffective exercises in poisoning oneself they are being luridly portrayed as:
Observe:
Unleash the Data on COVID-19 By Maryaline Catillon and Richard Zeckhauser* Given the lethality of the COVID-19 pandemic, the urgent need is for actionable information directing care towards treatments offering higher probabilities of improving outcomes and preventing death. In normal times, randomized control trials (RCTs) would be the gold standard for determining whether innovative medical treatments are safe and effective. But with 1,500 Americans dying every day, these are hardly normal times. There is an urgent need for high quality studies based on real world experience, which has already accumulated for many thousands of patients. Dr. Anthony Fauci, the nation’s pandemic physician in chief, said that RCT results will not be available "for months". The disease will not wait. RCTs, which randomly assign patients to a treatment or a control group, are only ethically acceptable when the safety and performance of a treatment is unknown. When ample data exists, as now, that criterion is not met. Analyzing real world data on actual outcomes, when it exists in abundance, offers an alternative approach to learn almost immediately. Moreover, it avoids the ethical challenge of an RCT, given that available data could predict outcomes. Massive numbers of COVID-19 patients are currently being administered "unproven" drugs based on medical decisions made by doctors. Massive numbers are not receiving any such drugs. Thus, carefully designed case control studies could leverage differences between ongoing protocols at large hospital systems and detailed information from patients’ electronic medical records. That could determine whether widely employed hydroxychloroquine, with or without azithromycin, provides significant benefits, and at which stages to which patients, and could provide similar information on the risks it imposes. It could yield the same information about remdesivir, and about many other drug treatments currently in use. [--> sounds familiar? That's been a line of argument I have pointed to for weeks] For each patient, doctors strive to optimize treatment in the current, uncertain environment. These drug versus non-drug decisions constitute an ongoing large observational study, in which the allocation to treatment and control groups varies widely. The large numbers of patients treated eliminates concerns that random variation might lead to misleading results. Those large numbers also yield results by demographic, comorbidities, and stage of disease. Leveraging real world evidence is more acceptable ethically when extensive information is already available. As decision theorists who have studied the methodological quality of vast numbers of RCTs, we are enthusiasts for well-conducted RCTs. But delaying public health recommendations till RCTs are completed is not appropriate in the present circumstance. Imminent threats are enormous and widespread data is easily at hand. The outcomes of the thousands of individuals who have already received drug therapies on an ad hoc basis should inform practice now . . . . High quality case control studies based on thousands of cases, the silver standard we recommend, are immensely faster than RCTs. Recent articles in the world’s leading medical journals show that they consistently yield the same major findings. Experience with the recommendations of antiretroviral therapy (ART) for HIV provides an instructive warning. Even though 20 years of observational studies demonstrated its enormous benefits, the World Health Organization waited until 2015 and the publication of the first set of RCT results (which reached the same conclusions) to make a "treat all" recommendation. Many lives were lost as the world waited for its recommendation. COVID-19 presents its own example. Through late March, medical authorities recommended the general public not employ masks to protect against it. In early April, that all switched: masks became strongly recommended. No RCT supported this reversal; little evidence was mounted. Yet officials applauded, the public widely complied, and the world was better off.
Well conducted includes ethical criteria. Of course. But such is obviously at a discount today. And notice the by now familiar context: decision theory.
PPS: I think it was von Hayek who said that one cannot make proper sense of how things could go wrong unless he had first worked out how they could ever go right. He said it on Economics, another context in which vast controversy has been amplified; needlessly undermining trust in what is fundamentally sound and at great cost to the vulnerable. A lesson in itself, written in blood and tears.kairosfocus_{May 22, 2020
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We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19. Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext
Ed George_{May 22, 2020
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Eh? This is what is says in the abstract:
The abstract does not say who the patients were. If they were hospitalized then they were inappropriate subjects. That has been the debate all along, how to prevent hospitalization. Do you know if these patients were not hospitalized?
Nope, nothing there gives the conditions you gave
I provide the mission statement of the FDA. The conditions I listed flow from that mission statement. Maybe you can delineate other more appropriate conditions. What is there besides safety and effectiveness that should be considered? The United States Food and Drug Administration (FDA) will generally only approve a new treatment as safe and effective for wider use if results indicate that the effects of the drug are in line with its claims, and if these benefits occur without causing unsafe adverse effects Safety is not an issue. If it it then debate it. Effectiveness is the issue but since the alternative is doing nothing, there is nothing lost in using it.jerry_{May 22, 2020
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BO'H, you are falling into selective hyperskepticism, gold standard evidence form. Accordingly, I draw your attention to the following, as has been pointed out since 56. Your crying no evidence in the teeth of potentially lifesaving evidence on the table is a serious matter. And in case you think my having made reference to decision theory is a dismissible idiosyncrasy, the article is coming out of the Kennedy School of Government. KF PS: I note:
Observe:
Unleash the Data on COVID-19 By Maryaline Catillon and Richard Zeckhauser* Given the lethality of the COVID-19 pandemic, the urgent need is for actionable information directing care towards treatments offering higher probabilities of improving outcomes and preventing death. In normal times, randomized control trials (RCTs) would be the gold standard for determining whether innovative medical treatments are safe and effective. But with 1,500 Americans dying every day, these are hardly normal times. There is an urgent need for high quality studies based on real world experience, which has already accumulated for many thousands of patients. Dr. Anthony Fauci, the nation’s pandemic physician in chief, said that RCT results will not be available "for months". The disease will not wait. RCTs, which randomly assign patients to a treatment or a control group, are only ethically acceptable when the safety and performance of a treatment is unknown. When ample data exists, as now, that criterion is not met. Analyzing real world data on actual outcomes, when it exists in abundance, offers an alternative approach to learn almost immediately. Moreover, it avoids the ethical challenge of an RCT, given that available data could predict outcomes. Massive numbers of COVID-19 patients are currently being administered "unproven" drugs based on medical decisions made by doctors. Massive numbers are not receiving any such drugs. Thus, carefully designed case control studies could leverage differences between ongoing protocols at large hospital systems and detailed information from patients’ electronic medical records. That could determine whether widely employed hydroxychloroquine, with or without azithromycin, provides significant benefits, and at which stages to which patients, and could provide similar information on the risks it imposes. It could yield the same information about remdesivir, and about many other drug treatments currently in use. [--> sounds familiar? That's been a line of argument I have pointed to for weeks] For each patient, doctors strive to optimize treatment in the current, uncertain environment. These drug versus non-drug decisions constitute an ongoing large observational study, in which the allocation to treatment and control groups varies widely. The large numbers of patients treated eliminates concerns that random variation might lead to misleading results. Those large numbers also yield results by demographic, comorbidities, and stage of disease. Leveraging real world evidence is more acceptable ethically when extensive information is already available. As decision theorists who have studied the methodological quality of vast numbers of RCTs, we are enthusiasts for well-conducted RCTs. But delaying public health recommendations till RCTs are completed is not appropriate in the present circumstance. Imminent threats are enormous and widespread data is easily at hand. The outcomes of the thousands of individuals who have already received drug therapies on an ad hoc basis should inform practice now . . . . High quality case control studies based on thousands of cases, the silver standard we recommend, are immensely faster than RCTs. Recent articles in the world’s leading medical journals show that they consistently yield the same major findings. Experience with the recommendations of antiretroviral therapy (ART) for HIV provides an instructive warning. Even though 20 years of observational studies demonstrated its enormous benefits, the World Health Organization waited until 2015 and the publication of the first set of RCT results (which reached the same conclusions) to make a "treat all" recommendation. Many lives were lost as the world waited for its recommendation. COVID-19 presents its own example. Through late March, medical authorities recommended the general public not employ masks to protect against it. In early April, that all switched: masks became strongly recommended. No RCT supported this reversal; little evidence was mounted. Yet officials applauded, the public widely complied, and the world was better off.
Well conducted includes ethical criteria. Of course. But such is obviously at a discount today. And notice the by now familiar context: decision theory.
kairosfocus_{May 22, 2020
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Jerry @ 118 - Yes, I have read the references. How do you come to your conclusion that they don't support my point?
One is a large meta analysis but does not say what was analyzed.
Eh? This is what is says in the abstract:
We searched PubMed, Embase, the Cochrane Library, Web of Science, medRxiv, and other relevant resources until May 13, 2020. We included randomized controlled trials and observational studies in which hydroxychloroquine was adminstered and compared to a control group. Data were extracted, and quality assessment of the studies was carried out. We evaluated symptomatic progression, mortality, viral clearance, the evolution of changes on chest CT imaging, and adverse events
So, they looked at "observational studies in which hydroxychloroquine was adminstered", and analysed "symptomatic progression, mortality, viral clearance, the evolution of changes on chest CT imaging, and adverse events".
The mission statement of the FDA is safe, effective and quality control. Any testing whether a RCT or otherwise would be to meet these mission statements. https://bit.ly/3ebNesz
Nope, nothing there gives the conditions you gave @ 32. It might be good to admit that you just made these conditions up.Bob O'H_{May 22, 2020
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kf @ 117 -
BO’H, at this point, I do not expect responsiveness to evidence due to the media and elite hysteria whipped up and following manifestly flawed attitudes to ethical and inductive logic issues.
That's because you don't provide any evidence of effectiveness. What evidence did the FDA use to change its stance? Was it anything other than Trump taking it? It looks to me like a political decision, but I'd be happy to be shown wrong. Your other evidence is a survey. In case you haven't notice, the effectiveness of drugs to treat disease isn't decided by a vote. If it did, beer would be the cure for the common cold.Bob O'H_{May 22, 2020
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Dr. Kevin Tracey said if famotidine works -- and that's a big if at this point -- it would be easy to use it on a widespread scale. "It's generic, it's plentiful and it's inexpensive," he said. But he emphasized that it might not work. "We don't know if it has any benefit. We really don't. I swear we don't," he said. "People are hoping for anything. But we need to do this clinical trial." ————- Kevin J. Tracey, a neurosurgeon and inventor, is the president and CEO of the Feinstein Institute for Medical Research, professor of neurosurgery and molecular medicine at Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, and President of the Elmezzi Graduate School of Molecular Medicine in Manhasset, New York. The Public Library of Science Magazine, PLOS Biology, recognized Tracey in 2019 as one of the most cited researchers in the world.rhampton7_{May 21, 2020
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Start taking Pepcid or heed the warning of the study’s authors (applies equally to hydroxychloroquine) Among the 1,536 patients in the study who were not taking famotidine, (aka Pepcid) 332, or 22%, either died or were intubated and put on a ventilator. Among the 84 patients who were taking famotidine, 8, or 10%, died or were put on a ventilator. "Compared to the rest of the patients, those who received famotidine had a greater than 2-fold decreased risk of either dying or being intubated," according to a statement by authors of the study at Columbia University Irving Medical Center. "Based on what we've learned in this study, it's encouraging," said Dr. Joseph Conigliaro, a coauthor of the paper and a physician at Northwell Health. "This association is actually really compelling." The drug, famotidine, has been on the market for nearly 40 years and is an active ingredient in the popular over-the-counter heartburn treatment Pepcid. Based on these results, Conigliaro said he knows that doctors might start prescribing famotidine to their coronavirus patients now, before the results of the clinical trial are known, but he doesn't recommend it. "I think doctors should wait for more data from the prospective trial," he said. He added that there's no evidence famotidine prevents infection, and "I would really caution against this. Taking famotidine might give them a false sense of security," he said. Only a clinical trial, where patients are randomly assigned to get either famotidine or a placebo and then studied, can determine if the drug really works against COVID-19. https://www.news.meredithlmg.com/tncms/asset/editorial/791a9514-c746-5c99-ae98-dd53d083003f/rhampton7_{May 21, 2020
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Doctors in Italy have finally began widely prescribing hydroxychloroquine in certain combinations in Rome and the wider region of Lazio with a population of around six million. According to Corriere della Sera, a well known Italian daily newspaper, Dr. Pier Luigi Bartoletti, Deputy National Secretary of the Italian Federation of General Practitioners, explains that every single person with Covid-19 that has early signs, like a cough or a fever for example, is now being treated with the anti-malaria drug. The drug “is already giving good results,” Bartoletti says while Malaysia reveals they have been using it since the very beginning. Bartoletti further adds that the drug: “Must be used with all the necessary precautions, it must be evaluated patient by patient. It can have side effects. But those that take it are responding really well.
Must be fake news, cannot possibly be true. Who are you going to believe, Dr. Bartoletti or Joe Scarborough? https://bit.ly/3cUmYCS Another crazy doctor from Italy who refused to participate in a RCT because it is unethical.
What is more incredible are the statements of Professor Christian Perronne, Head of the Infectious Diseases Department at the Garches University Hospital, made in an interview with a French weekly magazine. Referring to the European Discovery trial in which UK is taking part with only 800 patients, Perronne says: “I refused to participate because this study provides for a group of severely ill patients who will only be treated symptomatically and will serve as control witnesses against four other groups who will receive antivirals. It is not ethically acceptable to me... the protocol model chosen will not provide results for several weeks. Meanwhile, the epidemic is galloping. We are in a hurry, we are at war, we need quick assessments. America is to start yet another study which is to take one month even while one thousand people or more are dying worldwide today. “Even though the overwhelming evidence from large randomized studies is still lacking, I am in favor of a broad prescription for the following reasons: 1. We have a large body of evidence showing that in vitro hydroxychloroquine blocks the virus. We also have several clinical results indicating that this product is beneficial if administered early and we have no mention that it harms or is dangerous in this infection (only one study, poorly detailed, Chinese, on 30 patients with control group, did not observe any benefits but also no harmful effects). What is the risk of administering chloroquine straight away: nothing! 2. This drug is very inexpensive 3. It is well tolerated in long-term treatment. Personally, I have successfully used it clinically in the chronic form of Lyme disease for 30 years at a dose of 200 mg or even 400 mg/day... What are we waiting for? To have more dead?”
jerry_{May 21, 2020
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Another clinical trial of an alternative — don’t they know it’s all for naught? KF has unequivocally determined the proper treatment without resorting to an RCT! The HonorHealth Research Institute and HonorHealth in collaboration with the nonprofit research institute TGen are starting a clinical trial to use a combination of an antimalarial drug called atovaquone and the antibiotic azithromycin in patients with moderate-to-severe COVID-19 infection. “We know that a related regimen like hydroxychloroquine and azithromycin is being tried in clinical trials around the world and one of the problems with that regimen is that it can cause some cardiac toxicity,” said Dr. Sunil Sharma, one of the clinical trial’s principal investigators with dual appointments at HonorHealth Research Institute and TGen. “Atovaquone and azithromycin is relatively safer compared to that regime.” Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life-changing results. TGen is affiliated with City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases. https://chamberbusinessnews.com/2020/05/21/arizona-researchers-study-safer-treatment-option-for-coronavirus/rhampton7_{May 21, 2020
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“ has shown some effect but the reports are rather circumspect in claims.” Exactly the same with the French doctors treatment.rhampton7_{May 21, 2020
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RH7, strawman. Alternatives are always open. Remdesivir has shown some effect but the reports are rather circumspect in claims. KFkairosfocus_{May 21, 2020
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By KFs standards, Remdesivir should be standard protocol and the ongoing RCTs can be stopped... Both Dr. Faylor and Lemos would spend weeks in the hospital, much of that time sedated as doctors and nurses did all they could to keep them alive while their bodies fought the virus. Both families were approached and asked if they would consent to their loved one taking part in a new clinical trial only available to hospitalized patients with confirmed cases of COVID19. The clinical trial testing Remdesivir versus placebo was on the fast track as a potential drug therapy in treating COVID-19 with some early promising results. Their families agreed to their participating in the study, not knowing if their loved one would get the drug or not. As it turns out Dr. Faylor did receive the medication, something he credits for saving his life. Lemos did not, but is glad his family was willing to enroll him in the trial. “Clinical trials are a way to help everybody, and even though I didn’t get the medication, I would still participate if given the opportunity,” Lemos said. Dr. Faylor agrees. “I’m sure Remdesivir helped me and if the shoe was on the other foot I would do the same for my family member,” Faylor said. “The medications used in clinical trials are usually studied for years before being tested in humans thus the fact we were able to complete this large trial in less than two months is a major advance in the discovery of new treatments,” Andre Kalil, M.D., physician and primary investigator of the National Institutes of Health clinical trial of Remdesivir at UNMC, said. https://www.siouxlandproud.com/community/health/coronavirus/two-unmc-clinical-trial-participants-recount-their-brush-with-covid-19/rhampton7_{May 21, 2020
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Jerry – see my comments @ 44, 70 and 73. And have you found the FDA document that you claim give the conditions for RCTs that you set out
Your references do not support your point. Have you read them? One is a large meta analysis but does not say what was analyzed. So it is hard to know just what stage of the disease is being analyzed. The mission statement of the FDA is safe, effective and quality control. Any testing whether a RCT or otherwise would be to meet these mission statements. https://bit.ly/3ebNesz
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
jerry_{May 21, 2020
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BO'H, at this point, I do not expect responsiveness to evidence due to the media and elite hysteria whipped up and following manifestly flawed attitudes to ethical and inductive logic issues. Accordingly, I will simply cite a current data point relevant to the US, specifically, what the FDA just did:
FDA appears to soften stance on hydroxychloroquine after Trump says he takes malaria drug Published Tue, May 19 2020 1:41 PM EDT Updated Tue, May 19 2020 2:33 PM EDT Berkeley Lovelace Jr. The U.S. Food and Drug Administration said Tuesday that taking hydroxychloroquine is "ultimately" a choice between patients and their health-care providers, appearing to soften its earlier advisory against taking the anti-malaria drug outside of a hospital. "The decision to take any drug is ultimately a decision between a patient and their doctor," FDA Commissioner Dr. Stephen Hahn said in a statement to CNBC. "Hydroxychloroquine and chloroquine are already FDA-approved for treating malaria, lupus, and rheumatoid arthritis." The comments came a day after President Donald Trump said he has been taking hydroxychloroquine daily for over a week to prevent infection from the coronavirus. [--> in a context of contact or proximity with WH staffers who have contracted the disease] He said he asked his White House physician about the drug. "I asked him, 'What do you think?' He said, 'Well, if you'd like it.' I said, 'Yeah, I'd like it. I'd like to take it.'"
If it was the sort of evidential slam-dunk that the drug was ineffective and potentially highly dangerous as has been trumpeted for weeks now, there is no way the FDA would be visibly backing away from the sort of ferocious warnings it was issuing only several weeks ago. Instead, it is obvious that the weight of evidence that the cocktail, taken early enough under physician supervision is often highly effective is eroding the phalanx of elite and media pushback we have seen ever since Mr Trump suggested that this drug [cocktail] and Remdesivir had some promise. And going back to early April, shortly after the phalanx formed up, it is interesting to see a summary of physician opinions reflective of their estimates of likely effectiveness and reasonable safety:
65 Percent of Physicians in New Survey Would Give Anti-Malaria Drugs to Their Own Family to Treat COVID-19 ATLANTA, April 8, 2020 /PRNewswire/ -- Sixty-five percent physicians across the United States said they would prescribe the anti-malaria drugs chloroquine or hydroxychloroquine to treat or prevent COVID-19 in a family member, according to a new survey released today by Jackson & Coker, one of the country's largest physician staffing firms. Only 11 percent said they would not use the drug at all. Meanwhile, 30 percent of the surveyed doctors said they would prescribe the medications to a family member prior to the onset of symptoms if they had been exposed to COVID-19, a highly contagious virus that causes a pneumonia-like infection of the lungs. "Working in healthcare, we've learned the best way to get a candid perspective on treatment options from a physician is to ask: 'Would you give this to your family?'" said Tim Fischer, President of Jackson & Coker. "Families across the U.S. – and the world really – want to know what they can do to protect and save their loved ones." Jackson & Coker conducted the survey of 1,271 physicians from 50 states from April 4 to April 7. It conducted the survey not to influence the debate in treating patients with anti-malarials but to make sure the voice of physicians is represented. It has a margin of error of +/- 3 percent with a 95 percent confidence level of the doctors surveyed. Chloroquine and hydroxychloroquine have been on the market for many years and treat several different forms of malaria. Hydroxychloroquine, however, is also used to treat lupus and rheumotoid arthritis. The two anti-malaria drugs were given emergency approval for off-label usage by the Food and Drug Administration last week to treat COVID-19. Assuming there were no clinical contraindictions, physicians were asked if they would prescribe or have another doctor prescribe either chloroquine or hydroxychloroquine off label if a family member developed symptoms of COVID-19. While 54 percent responded yes, another 11 percent said they would if the disease became serious. Twenty-four percent said they would need more data to decide; another 11 percent said they would not prescribe it. Among the specialties most willing to utilize the anti-malarials were anesthesiologists, surgery subspecialists, physicians in diagnositic medicine, women's medicine, internal medicine and hospital-based medicine. Physicians who were more cautious and wanted more data about using the anti-malarials to treat COVID-19 tended to be doctors under the age of 45, academics and those who practice medicine in a healthcare system. Among hotspots states where there are the highest per-capita cases of COVID-19, physicians in New Jersey, Louisiana, Washington and Michigan showed the greatest support for usage of the medication for a family member or themselves. In New Jersey, for example, 77 percent of doctors said they would prescribe for a family member early in an illness. In New York, 53 percent of doctors said they would prescribe for a family member. In Louisiana, 69 percent said they would prescribe for a family member, and 60 percent of doctors in Michigan said they would prescribe for a family member. Jackson & Coker also found that 67 percent of surveyed physicians said they would take the medications themselves to treat COVID-19. Fifty-six percent said they would take the anti-malarial if they displayed symptoms, and another 11 percent said they would take the medications if they got very sick from the virus. "When a medical crisis like this emerges, the voice of physicians needs to be heard. Their insight is powerful for families faced with uncertainty," Fischer said.
The sustained trend is clear, and it is clearly consistent with Dr Raoult's cumulative pattern of results. KFkairosfocus_{May 21, 2020
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Welcome Back JVL, I was wondering where our favorite Corona Virus Cheerleader went. ;) Andrewasauber_{May 21, 2020
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A Wisconsin woman with lupus has taken hydroxychloroquine for 19 years and still got COVID-19
https://www.msn.com/en-us/health/medical/a-wisconsin-woman-with-lupus-has-taken-hydroxychloroquine-for-19-years-and-still-got-covid-19/ar-BB14qnpEJVL_{May 21, 2020
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kf - Yes, there numbers are there in the case-control studies. The lack of effect of HCQ has bee replicated (albeit not with RCTs). Jerry - see my comments @ 44, 70 and 73. And have you found the FDA document that you claim give the conditions for RCTs that you set out @ 32?Bob O'H_{May 21, 2020
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He’s been curiously silent about the review of high quality case-control studies that suggests no curative effect, and a higher risk from side effects.
Why don't you present all this information. I am unaware of any nor have I seen any presented elsewhere. And I have looked and so has Rhampton who has not presented it even though he has presented close to 50 internet reports.jerry_{May 21, 2020
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BO'H, the numbers are clearly there and the pattern of action is clearly there. The issue of studies that tilt the field is there too, note FDA's backing current off. KFkairosfocus_{May 21, 2020
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You know that the French doctors did not do an RCT (and apparently are not doing one currently), That’s why, among other reasons, RCTs are done.
Raoult isn't even doing a case-control study. And kf keeps on citing a piece that says that high quality case-control studies are what are needed. He's been curiously silent about the review of high quality case-control studies that suggests no curative effect, and a higher risk from side effects. Apparently he's not interested in case-control studies, of whatever quality.Bob O'H_{May 21, 2020
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Jerry, in some cases, they are unethical as violating the do no harm principle. It seems ethics are at a sadly steep discount today and we need to learn somewhat regarding responsible inquisitiveness vs vicious curiosity and other intellectual virtues/vices. In the extreme case, more lives were saved by the knowledge gained through the holocaust than were lost in it but the taint was an unbearable ethical contradiction. A decades long effort was engaged to recreate the knowledge in an ethically sound manner. In our case, the proposed gold standard investigations will directly expose people to ravages of a deadly, highly contagious disease through deliberately mislabelled sugar pills or the like; something no consent form can erase. Similarly, by dismissing evidence in hand and refusing to make due distinctions while advocating a process that implies long delays, hundreds of thousands of plausibly avoidable deaths have been put in train. Of course, it is imagined that evidence in hand is poor or is not real evidence. That points to selective hyperskepticism and its harmful consequences. We need to recognise that hyperskepticism and the like are not intellectual virtues and return to the virtue of prudence. KF PS: Pharmacology is the study of poisons in small doses.kairosfocus_{May 21, 2020
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No one is against RCTs per se. It is just that. they are not necessary in every case to make a good decision. Timing is critical for several hundred thousand unknown people who will die if they are not given an effective treatment. We know the numbers. We are understanding approximately the number of people that will die if there is no treatment. And "no treatment" for the virus is the the standard treatment now recommended by the medical community. In such a situation the use of a treatment that has promise is mandatory. Not just HCQ + but any other treatment that has proven beneficial. I can provide a dozen alternatives that have shown some positive effects so no one is advocating HCQ as the only possibility. To insist on RCTs is cynical at best because it takes months to implement even at its fastest. To argue against HCQ one has to argue that it is not safe or effective. We know the CDC and WHO have recommended the drug for prophylactic use so it can not be considered dangerous. I was given the drug prior to a trip to Africa 6 years ago. Yes, some may have an adverse reaction but some have an adverse reaction to over the counter drugs. Some people cannot take common pain killers such as aspirin, ibuprofen or acetaminophen (the last known better as Tylenol could kill with an over dose.) We know HCQ + is effective in that there are a myriad number of positive results with no negative results when used appropriately. The HCQ combinations are used most effectively in the first 10-12 days after infection when the viral load is low.. So the drug combinations are effective. To argue that it is not 100% effective is specious at best as any treatment will not be universal. So anyone arguing against HCQ + should do so on the basis of safe and effectiveness. Presenting negative opinions or the odd negative occurrence, or the failure in inappropriate situations is not a valid argument. But that is what we are getting. For example, all the reports from the VA are irrelevant for proving negative results. Any report from hospitalization is irrelevant for proving negative effects. But we are still getting these reports in comments here.jerry_{May 21, 2020
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The research, which was published in the medRxiv online depository (https://www.medrxiv.org/content/10.1101/2020.04.16.20065920v1.full.pdf) x evaluated data from 368 COVID-19 patients. The study, which was paid for by grants from the National Institutes of Health and the University of Virginia, has not been peer-reviewed. “We performed a retrospective analysis of data from patients hospitalized with confirmed SARS-CoV-2 infection in all United States Veterans Health Administration medical centers until April 11, 2020,” the researchers explained. Some 97 patients had been treated with just hydroxycholoroquine, 113 were treated with hydroxycholoroquine and the antibiotic azithromycin and 158 received “standard supportive management” for COVID-19. ACKNOWLEDGMENTS This work was supported by National Institutes of Health (USA) grants (R01EY028027 and R01EY029799), DuPont Guerry, III, Professorship, and University of Virginia Strategic Investment Fund to JA. The funders had no role in study design or conduct, data collection, analysis, or interpretation, manuscript writing, or the decision to submit the manuscript for publication. The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, U.S. Department of Veterans Affairs, nor does mention of trade names, commercial products, or organizations imply endorsement by the United States government. This paper represents original research conducted using data from the Department of Veterans Affairs and is, in part, the result of work supported with resources and the use of facilities at the Dorn Research Institute, Columbia VA Health Care System, Columbia, South Carolina. https://www.foxnews.com/science/covid-19-hydroxychloroquine-showed-no-benefit-more-deaths-va-virus-studyrhampton7_{May 20, 2020
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