Dr Zelenko strikes yet again (at 911 patients and counting . . . )

_{kairosfocus

April 3, 2020

Defending our Civilization, Medicine, rhetoric}

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Here is a panel discussion for a rapidly organised conference:

https://www.youtube.com/watch?v=-Oq6IOP1sd8

We need to hear this, where 44 million donated tablets are already in hand. END

Comments

kf @ 79 -
It would be nice to have done large scale studies [maybe on colds and flu etc] a decade ago post SARS, to get HCQ characterised as a broadly acting antiviral,
It was done. The results were negative. Paton NI, Lee L, Xu Y, et al. Chloroquine for influenza prevention: a randomised, double-blind, placebo controlled trial. Lancet Infect Dis. 2011;11:677-683. [PMID: 21550310] doi:10.1016/S1473-3099(11)70065-2
Dr Oz is rightfully complaining that his outpatient study (similar to Raoult’s) was terminated by regulatory decision. That means, politics is locking off responsible investigation, right there in NY.
If it was similar to Raults' then it should have been stopped for ethical considerations. There already are trials running, and it's surely unethical to allow another one to go ahead that will be useless, but where we know some of the patients will suffer.
Where, while it is highly desirable to use structured experiments and statistical techniques, in many cases such is not feasible or is unethical, and we are forced to infer and test dynamics on cases and comparative cases.
This is a large part of what I do (albeit not in a medical context). Seriously, it means you need a larger sample size, which means the trial takes longer to run. In this context, that means more deaths. We know how to do these trials - there is a framework in place to run them efficiently, so why waste time, money and lives on studies that are close to useless?Bob O'H_{April 8, 2020
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If they know what group they’re in that’s not even single blinded. Heavens.
Change my comment to
Who would ever volunteer to possibly be in the control group
Does that make you happy?jerry_{April 8, 2020
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What happens mostly is that people volunteer to be in a study and they are aware that they may be given a placebo
I’m well aware of how research studies are designed as I helped design a couple in my past life. But none were such that being in the placebo group had a much high risk of death. The side effects of the drugs being proffered are not that serious so that is not an issue. When you have a protocol with near 100% effectiveness running a double blind test is equivalent to sentencing some people to death. Do you defend that? You should listen to Zelenko. He discusses all the aspects of this.jerry_{April 8, 2020
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"Who would ever volunteer to be in the control group." If they know what group they're in that's not even single blinded. Heavens.Jim Thibodeau_{April 8, 2020
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Jerry: Who would ever volunteer to be in the control group. What are the ethics of establishing a control group knowing a large number will die? What happens mostly is that people volunteer to be in a study and they are aware that they may be given a placebo. The gold standard study is one that is double blinded: i.e. the patients and the people monitoring their condition do not know who has had the 'drug' being tested and who hasn't. Such practices are tightly controlled and help make sure that any effect detected has to be purely down to the intervention having an actual effect. When you are unsure if a medication has an effect then you are NOT consigning people to death. You DON'T KNOW if the medication has a positive effect and you want to make sure you are right to say it definitely does have a positive effect before you administer it to other sufferers. There is also the matter of figuring out what is the appropriate dosage. Since many drugs, especially aggressive ones can have nasty side-effects (more and more severe with larger doses) another aspect of a study will be to attempt to find the minimal dosage that still conveys a positive effect.JVL_{April 8, 2020
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@81 Jerry
What are the ethics of establishing a control group knowing a large number will die?
Jerry, please, ethics are illusory. Darwin and his followers have liberated us from such sentimentalist non-sense.Truthfreedom_{April 8, 2020
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^^^^^^^^^^ BINGO Jerry! I wonder if, God forbid, Bob had this horrid disease whether or not he would want to be in a 'control group?' Or whether he would want to make damn sure he was getting real medicine? Shoot, I wonder if Bob can even answer that question honestly? Guess, for the sake of science, we just have to give Bob the disease and see how Bob responds! I hope you know I'm kidding Bob.bornagain77_{April 8, 2020
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How many were in the control group
Tens of thousands. I believe they’re all dead. Now I am waiting for the nitpicking of my extremely sarcastic comment. Probably a more accurate comment is that the control group contains all the dead. In Zelenko’s group there was one dead out of a thousand. He didn’t take the medicine. So was he really an example of his small control group. Who would ever volunteer to be in the control group. What are the ethics of establishing a control group knowing a large number will die?jerry_{April 8, 2020
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PPS: Let's note Wiki remarking on what the dismissive term, anecdotal, typically means -- for clarity:
Anecdotal evidence is evidence from anecdotes: evidence collected in a casual or informal manner and relying heavily or entirely on personal testimony. The term is sometimes used in a legal context to describe certain kinds of testimony which are uncorroborated by objective, independent evidence such as notarized documentation, photographs, audio-visual recordings, etc. When used in advertising or promotion of a product, service, or idea, anecdotal reports are often called a testimonial, which are highly regulated[1] or banned in some[which?] jurisdictions. When compared to other types of evidence, anecdotal evidence is generally regarded as limited in value due to a number of potential weaknesses, but may be considered within the scope of scientific method as some anecdotal evidence can be both empirical and verifiable, e.g. in the use of case studies in medicine. Other anecdotal evidence, however, does not qualify as scientific evidence, because its nature prevents it from being investigated by the scientific method. Where only one or a few anecdotes are presented, there is a larger chance that they may be unreliable due to cherry-picked or otherwise non-representative samples of typical cases.[2][3] Similarly, psychologists have found that due to cognitive bias people are more likely to remember notable or unusual examples rather than typical examples.[4] Thus, even when accurate, anecdotal evidence is not necessarily representative of a typical experience. Accurate determination of whether an anecdote is typical requires statistical evidence.[5] Misuse of anecdotal evidence is an informal fallacy[6] and is sometimes referred to as the "person who" fallacy ("I know a person who..."; "I know of a case where..." etc.) which places undue weight on experiences of close peers which may not be typical. In all forms of anecdotal evidence its reliability by objective independent assessment may be in doubt. This is a consequence of the informal way the information is gathered, documented, presented, or any combination of the three. The term is often used to describe evidence for which there is an absence of documentation, leaving verification dependent on the credibility of the party presenting the evidence.
Didier Raoult is the leading researcher on this sort of disease in France, comparable in renown to Dr Fauci. He is a legitimate expert. The notion that his cases will be informal, with unstructured observations is nonsensical. The notion that he is cherry-picking from a wider cluster of outcomes that are not favourable on balance [like dishonest ad testimonials] or otherwise represents a sloppy choice that becomes grossly unrepresentative is even more nonsensical. Unless objectors can put up specific reason to reject his credibility, Dr Fauci is a credible, expert witness. In short, the burden of warrant on credibility shifts to the objector here. Further to this, the case study method -- common in managerial and operations contexts -- works, not by blind comparison but by close examination of material facts suggestive of dynamics at work. Here, there are in vitro studies and day by day plots on trends with virus loads, leading to the day five zero point he has presented. These are obviously based on clinical case files. The only reasonable objection I can see, on the known in vitro result, is good evidence that the in vivo pattern is diverse because the drug does not get to where it is needed or that considerations of toxicity overwhelm the potential success. 65 years of use in other context and the sort of actual collective experience Dr Oz summarises, makes such further implausible. Toxicity is acceptable and the drug is known to get into the bloodstream and tissue in active concentrations, on reasonable dosages. In that context, it is observed in literally hundreds of cases, to be acting as is reasonable to expect. Comparatives to see what else is cost-effective can be done but that will be already weighted by the low cost of this drug and its manageable side effects profile. As for "THE big-S Scientific, big-M Method" there 'ent no such beast. There is no generic, one size fits all and only Sciences as conventionally labelled surefire method of empirical investigation. The method we are taught in school is valid as a general approach to inductive, empirically based investigations i/l/o inference to best current explanation per collective judgement of peer experts, but it is by no means confined to the sciences as conventionally labelled and is sufficiently broad that degree of warrant varies, field by field, case by case. Where, while it is highly desirable to use structured experiments and statistical techniques, in many cases such is not feasible or is unethical, and we are forced to infer and test dynamics on cases and comparative cases. For example, in the midst of the gold standard science, Physics, there is a sub-discipline, Astronomy and Astrophysics. So, the point is, careful, observation based inference to best current [thus, revise-able] explanation driven investigations come in a spectrum and extend far beyond the conventional sciences into things like medical practice, engineering and management. That's what we are up against, on the battlefield. In a world war, with the clock ticking on triggering a massively destructive depression that would cost a lot of lives through that impact. Decisions have to be made in the face of uncertainty: unknown unknowns likely lurk like irritable sleeping dragons whose tails we are tickling.kairosfocus_{April 8, 2020
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BO'H: cumulative impact in itself has a logical force all of its own that transcends mere isolated story-telling: the logic of observational as opposed to experimental studies. It would be nice to have done large scale studies [maybe on colds and flu etc] a decade ago post SARS, to get HCQ characterised as a broadly acting antiviral, and also several other candidates. After all, in vitro studies (another key aspect of warrant) were showing potential. But for one reason or another . . . I suspect, regulatory-system influenced market failure esp for HCQ . . . it was not done. It can be done but is going to take considerable time and effort we don't have now. Dr Oz is rightfully complaining that his outpatient study (similar to Raoult's) was terminated by regulatory decision. That means, politics is locking off responsible investigation, right there in NY. And indeed, there are serious ethical constraints on treating patients with a fast-acting, life threatening contagious disease with sugar pills. Especially, where lockdown measures cannot be long sustained. (Mind you, the local one seems to have done wonders for my blood pressure, per clinic results that had be doubting the machines at first, then the second test was even better and consistent with relaxation! [That effect, too, should be studied!) Frankly, I would be more comfortable in doing treatment by blocks and plots with various credible alternatives then looking at cross-tabulated statistical performances looking for the pattern of variation turned into variances, on the premise, variances add. In that context, observing people getting plausible but varied treatments with consent, whether organised before the fact or noted after the fact could be telling us things. Here, we have persistent indications that HCQ-involved cocktails, esp with whatever antibiotic hits secondary infection and Zn supplements is having dramatic impact in various countries and runs of cases, above and beyond conventional treatment approaches [there's your de facto baseline "control"]. The odds that such results in the high 95+% success range are happening by chance are vanishingly low. In an urgent, battlefield-like situation, that looks like warranting acting on what is plausibly a best current explanation, even on balance of evidence that does not reach moral certainty. Which, recall per pessimistic induction, is not in the gift of science when it comes to explanatory frameworks. Observational facts are another thing entirely. KF PS: Say, the odds are that in a given case, HCQ has no effect and cure vs non cure is 90:10, which is like vulnerable cases. Now, inject treatment H, in a string of 1,000 cases. What is the likelihood that we are on a prong of that tree of possibilities such that 98% or better of these cases are in the cured column on a drug with no impact? Especially, given in vitro evidence of antiviral impact at plausible in-tissue concentrations? Especially where the 90:10 ratio is from the pool of 100's of k cases given conventional treatments? We here have a natural contrast factor and a noticeable, rapidly acting shift in outcomes, frequently with noticeable improvement in a day and elimination of viri on a progressive trend to zero in about 5 days once treatment starts. Alternatives don't show that trend or that steep of a trend. Case after case after case. Now, you tell me how we are to prefer the explanation, little or no impact, outcome by chance.kairosfocus_{April 8, 2020
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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.”
How many were in the control group?Bob O'H_{April 7, 2020
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“In a war you use whatever gets the job done!” Yeh like that Tennessee hillbilly in WWll who came up with the idea to put a sawtooth device on tanks to get through the hedgerows, that the tank was not designed with that in mind didn’t matter. I am convinced that HQ is safe whether it is efficacious we need to wait for the tests. We have to keep in mind that statistical coincidences happen all the time. Vividvividbleau_{April 7, 2020
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It is just crazy that so many people are fighting against this. In a war you use whatever gets the job done!bornagain77_{April 7, 2020
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Wow just heard Dr Mark Siegel on Tucker Carlson. He tells the story of this 96 year old Florida man who said one night to him “ I’m not going to make it, I’m feeling weak, I am short of breath I am coughing I can’t get off the couch. I’m not going to make it” The next day he was prescribed HQ with antibiotics per his cardiologist, he got up the next day and he was fine. Here is the kicker, the man was his father! Vividvividbleau_{April 7, 2020
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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. KFkairosfocus_{April 7, 2020
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PS, notice how digitalisation is moving mainstream? KFkairosfocus_{April 7, 2020
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Jerry, ah, the sting in the tail. KFkairosfocus_{April 7, 2020
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Meanwhile the cure cost 7 cents a day. That’s an exaggeration since it’s only the cost of the zinc. The cocktail of three drugs cost $4 a day for 5 days. And for that the world has gone upside down. Of course the doctor vist will cost $100+jerry_{April 7, 2020
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Posted this yesterday “The IHME model as of April 5th predicts that NY State will need 69k beds with only 16.5 k actually needed so far. The projection is for 12.3 k ICU beds actual 4.3k” It is reported that Cuomo is saying they don’t need any hospital beds or ventilators. Will have to check and verify that out for myself. I wonder what the rest of the state needs are. Vividvividbleau_{April 7, 2020
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@68 jerry
Can you read or better question is will you read?
Naturalists rely on infused science. Hard work was not meant for them.Truthfreedom_{April 7, 2020
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why the need for the additional capacity?
Can you read or better question is will you read? In this case it is watch. The links I sent explain it all. Hydroxychloroquine increases the zinc transport several fold. As the concentration of zinc goes up, the presence of the virus gets less and less and eventually disappears. By the way as I was writing this, the Amazon driver delivered my zinc sulfate. So I have enough now for about 20 people if they should come down with the virus. My guess is that all of the nay sayers or nitpickers here who constantly find small things to complain about would use this treatment in a millisecond if it applied to them or their family.jerry_{April 7, 2020
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Happy Paul Nelson Day!Jim Thibodeau_{April 7, 2020
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Bob O'H And plant epidemiology and human ('animal') epidemiology are NOT the same. Biology is an immense, complicated field.Truthfreedom_{April 7, 2020
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@64 Bob O'H Then you should know that zinc requirements for healthy, normal cells, and for cells undergoing pathological states are not the same. So your snarky response was a fail.Truthfreedom_{April 7, 2020
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Truthfreedom - I'm both statistician and biologist. My first degree was in genetics and statistics, my PhD is in plant epidemiology. I have a Finnish docentship in quantitative ecology, and I'm now a professor of statistics. I can also call on the services of my wife who's definitely a biologist, and that includes working in medical labs.Bob O'H_{April 7, 2020
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Ok@62 Bob O'H Are you reading Seversky's thoughts? I do not think so. :) Do cells routinely fight SARS-Cov-2? Well Bob O'H, you are a statistician, not a biologist. I am wrong?Truthfreedom_{April 7, 2020
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TruthFreedom - this might help.Bob O'H_{April 7, 2020
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@60 Seversky
The question is, if there are already zinc transport mechanisms routing as much zinc as is needed into the cells,
Needed for what?Truthfreedom_{April 7, 2020
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The question is, if there are already zinc transport mechanisms routing as much zinc as is needed into the cells, why the need for the additional capacity?Seversky_{April 7, 2020
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My understanding is that zinc is an essential nutrient in cells and that there are already efficient inbuilt transport mechanisms to supply it.
Apparently you have not been reading the links provided. The addition to zinc to Hydroxychloroquine kills the virus. Hydroxychloroquine acts an ionophore allowing zinc into the cell. Here is a major medical site in the US discussing it. https://www.youtube.com/watch?v=U7F1cnWup9M&list=PLQ_IRFkDInv-NvRRUN0aqe51sMs188k8z&index=18 Another link https://www.youtube.com/watch?v=BIymfznD7YA Both point to South Korea as the example of using this to cure individuals with the virus.jerry_{April 7, 2020
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