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Inference Review devotes issue to COVID-19

Denyse O'Leary
April 15, 2020
Culture, Intelligent Design, Naturalism
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Here. Special Reports

SARS-CoV-2 and COVID-19

Hat tip: Philip Cunningham

Comments
you continue to display your complete ignorance on how clinical trials are run.
We all know how studies are done. Control groups are done when you expect small differences due to the intervention or you expect that there are psychological factors involved or you expect rigging the results is an issue. The ignorance on display here and elsewhere is that a control group is needed to see an effect. Just assume the control group is the thousands who died from a different treatment. If you have 99% success with a certain treatment than who needs a control group. Only an idiot would think that isn't a successful intervention. If you could find amongst the thousands who entered hospitalization that there was one or two treatments that led to some being quickly released in a few days, then you would have a natural experiment. That is what we have. We have a treatment by several doctors leading to quick release. That should be celebrated not nitpicked with irrelevancies. Otherwise we have to suspect the motives of the nitpickers.jerry
April 18, 2020
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BO'H & EG: In this case, ethical failure is precisely the issue at stake. Let me cite in its long form, a famous aphorism of Hippocrates of Cos, often clipped in Latin to Ars longa, vita brevis:
Life is short, and Art long; the crisis fleeting; experience perilous, and decision difficult. The physician must not only be prepared to do what is right himself, but also to make the patient, the attendants, and externals cooperate.
In the face of finitude, fallibility and the challenges of judgement, decision and action, the physician [and by extension other professionals] must be prepared to act aright. This famously includes, "first, do no harm." It matters not what is said about how placebo designs avoid ethical failure as there is a consent sign-off, or that neither the one who administers nor the one who receives knows beyond that X may or may not be a drug. In dealing with "zits," or the like, that might be enough. But that is precisely what is not the case before us. As is noted, in the solemn name, ceremonies and colours of the most honoured of professions [save, one] and in the face of a deadly fast acting, fast spreading disease known to rapidly cause organ damage and death, it is proposed to design test treatments that will subject significant numbers of patients to "treatment" with sugar pills or the like. There is a comparison, one that I used here when it became clear that authorities were trifling with the dangers of a volcano, eventually costing (by official count) nineteen, their lives. Namely, Russian Roulette. What is worse, in the name of the alleged excellence of such a test (one that it is admitted will take perhaps a year to complete) evidence from case studies and tracking reasonably credible candidate treatments is being trashed as though it were no evidence or grossly inadequate evidence or utterly lacking in probative value. The Guardian article is only one case in point. As I have pointed out repeatedly, it is simply not in the gift of empirical studies and linked inductive reasoning, to deliver proof. At least, beyond what the Greeks termed pistis, rhetorical proof. Evidence of weight that in the best case may attain moral certainty, or is at least reasonable, reliable and responsible to act on. But that is precisely what case based reasoning also delivers [without need for Russian Roulette or deceit with life on the line] and that is what is routinely being trashed. Next, we face a fast-moving, fast spreading epidemic, where "wait until our gold standard study delivers results" is tantamount to discrediting results of significant worth that are in hand, grow with cases and point to something that can be tried right now, with reasonable hope of success and cost. Here are Zelenko's words from his March 23 letter to the world's physicians:
Given the urgency of the situation, I developed the following treatment protocol in the pre-hospital setting and have seen only positive results: 1. Any patient with shortness of breath regardless of age is treated. 2. Any patient in the high-risk category even with just mild symptoms is treated. 3. Young, healthy and low risk patients even with symptoms are not treated (unless their circumstances change and they fall into category 1 or 2). My out-patient treatment regimen is as follows: 1. Hydroxychloroquine 200mg twice a day for 5 days 2. Azithromycin 500mg once a day for 5 days 3. Zinc sulfate 220mg once a day for 5 days The rationale for my treatment plan is as follows. I combined the data available from China and South Korea with the recent study published from France (sites available on request). We know that hydroxychloroquine helps Zinc enter the cell. We know that Zinc slows viral replication within the cell. Regarding the use of azithromycin, I postulate it prevents secondary bacterial infections. These three drugs are well known and usually well tolerated, hence the risk to the patient is low . . . . In sum, my urgent recommendation is to initiate treatment in the outpatient setting as soon as possible in accordance with the above. Based on my direct experience, it prevents acute respiratory distress syndrome (ARDS), prevents the need for hospitalization and saves lives.
It is of course a matter of record, that Dr Raoult, a distinguished researcher, has undertaken studies, which at the 80 patient stage led France to a measure of approval, and shortly thereafter the US FDA moved to a second level FDA approval. A significant cluster of countries including the two largest by population in the world and the two largest by population in this hemisphere, have given some degree of approval. All that is asked is to recognise that and that it is not without warrant; though obviously further warrant, exploration of other treatments and more are highly desirable, especially vaccinations. Unfortunately, the best bet on that is, a year out. Coming back to use of placebos, we need to recognise what a placebo is and that there is no responsible justification to dismiss other evidence or to subject patients in the face of a fast acting deadly plague to something comparable to Russian Roulette when there is evidence [which needs to be recognised not trashed] that there are possibilities that do not depend on frankly, deception. However disguised. We need to seriously rethink what we are doing, proposing to do or advocating. KF PS: BO'H, kindly, stop wrenching plain enough words into strawmannish pretzels. Patients obviously have something that makes them be cases, and are facing consequences of a fast acting, deadly disease in the relevant situation. Subjecting them to a regime where pills are given [for example] that bear the same label but in some cases are sugar pills rather than a credibly active agent, is exactly where the issues lie. Especially in a context where gold standard rhetoric is being used to dismiss other evidence that is material. Hence why in cases of serious and fast acting peril, I have to seriously question the ethics and epistemology at work.kairosfocus
April 18, 2020
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KF, you continue to display your complete ignorance on how clinical trials are run. You focus on the fact that placebos are falsely labelled but completely ignore the fact that they are informed in advance that they may be receiving a placebo and that neither the doctor nor the patient knows which are which. All pills could just as easily be labelled as sugar. And during the trial, all participants still receive the standard level of care. We are all hoping that this treatment is effective, but there is too much contradictory information to know if it is effective. But we do know that there are some significant risks associated with the drug. It is used for lupus and malaria because the risks associated with the disease far outweighs the risks associated with the drug. By all accounts, this treatment appears to be most effective early in the infection. But we also know that the vast majority of people infected recover without any need for medical intervention.Ed George
April 18, 2020
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kf - once more, because you don't seem to understand how these trials work. No, we don't get people to take "deliberately mis-labelled sugar pills" and then expose them to the disease. That would be unethical and evil. People who already have the disease are given the opportunity to enter the trial. They are told that they could be given a treatment, or a control (I assume a placebo here, but in other contexts it can be the standard treatment), and neither they or their doctor will know which it is. If they agree, i.e. if they give informed consent, then they will enter the trial.Bob O'H
April 18, 2020
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EG, false, as the analysis cited and linked onward at 8 above draws out. That is over and above taking people credibly suffering a fast-acting deadly plague and giving them sugar pills (with false labels) under the solemn colours of medical treatment. KFkairosfocus
April 18, 2020
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BO'H: Do you wish for me to elaborate as, exposing people to the ravages of a deadly disease, having taken deliberately mis-labelled sugar pills? That is discussed in more detail, with links above, its meaning was never in serious doubt. KFkairosfocus
April 18, 2020
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EG & KF,
However, if I were a few years older, was obese, or had some underlying condition, I would volunteer in a flash. If the treatment is effective, I have significantly increased my odds of survival.
To amplify this point a bit, I would want my participation in such an experiment to have as much value as possible, so I would prefer that the experiment be blinded and have randomized controls (given what I know about the current situation). This talk of "mislabeling" pills and "deceiving" patients is not appropriate here, assuming patients are informed how the experiment is conducted.daveS
April 18, 2020
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KF
Next, you duck the basic challenge of knowingly mislabelling sugar pills or the like [snip ], deceiving patients, and in this case exposing patients to a fast acting deadly disease.
Nobody is deceiving patients or exposing them to a deadly disease. Patients must volunteer to be in a clinical trial, knowing that they may receive a placebo. In most trials, the patients still receive the standard level of care. If I had COVID-19, I probably wouldn’t volunteer for the trial because of the known risks of the drug and because I am in a low risk group for fatal complications. However, if I were a few years older, was obese, or had some underlying condition, I would volunteer in a flash. If the treatment is effective, I have significantly increased my odds of survival.Ed George
April 18, 2020
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Umm, that sailor died 5 days ago...ET
April 18, 2020
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kf, no. The trials are for people who already have the disease.Bob O'H
April 18, 2020
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JT, RIP indeed. KFkairosfocus
April 18, 2020
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BO'H, that is the direct implication of using sugar pills or the like in this case. KFkairosfocus
April 18, 2020
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kf - nobody is suggesting "exposing patients to a fast acting deadly disease" in these large trials.Bob O'H
April 18, 2020
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One of the sailors on the USS Teddy Roosevelt has died from COVID-19. RIP Chief Petty Officer.Jim Thibodeau
April 18, 2020
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BO'H, placebo driven studies are the manifest context. There is a de facto standard treatment, that given to most cases, leading up to the last ditch ventilators lately the subject of much media huffing and puffing. Next, you duck the basic challenge of knowingly mislabelling sugar pills or the like [Niacin to promote skin itching and perception of active treatment], deceiving patients, and in this case exposing patients to a fast acting deadly disease. Something is wrong with how we approach empirical investigations, as I went on to discuss here. KFkairosfocus
April 18, 2020
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BO’H: again, you overlook material evidence and the issue that undermines the whole framework of using placebos as if that were a gold standard.
I don't think I've even mentioned placebos. Of the three links you give, the first outlines when placebos can be ethically problematic, but I don't see that any apply here (particularly as there is no "standard treatment"). The second raises some interesting ideas, but it's speculative so I wonder if any research has been done since to see whether they are actually a problem. FWIW I don't think the first will influence the results of a trial (because all arms get the same information). The second might have an effect, but presumably only in cases where the active drug has side effects. The third link is explicitly about when there is a standard therapy, which is not relevant here.Bob O'H
April 18, 2020
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DS, policy is wider than declared state policy -- the point of defining governance as: how the big decisions are made and are made to stick. (Hence, BTW, my reference to the idea of using "seven mountains" as a handy model of key centres of influence.) There is, on paper, a reasonable policy by the US FDA, though the amount of bureaucracy seems dubious. Looking from a wider viewpoint, I am seeing serious signs of intellectual and ethical breakdown leading to serious trouble in the face of an ongoing deadly pandemic. KFkairosfocus
April 17, 2020
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KF, Maybe you and I don't have any disagreement on policy (in the US, which is all I am vaguely familiar with) around the drugs Raoult studied? I don't think either of us is suggesting any specific changes to current policy.daveS
April 17, 2020
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DS, please see the new OP and onward discussion, JT brought to my attention a Guardian article that is almost a caricature of the concerns I have. What we first need to do is to realise we have seriously blundered in logic, epistemology and ethics, turning selective hyperskepticism into a fallacious substitute for prudence. In that context, we need to rethink how we assess empirical observation, evidence and reasoning, thus context-relevant degree of warrant towards necessarily risky decisions. We need to bring back the principle of moral certainty, and recognise when errors are acceptable or affordable. As applied to this situation, it would be nice to see reasonableness in response to Dr Raoult et al, and some willingness to recognise that he is not shilling for snake oil, with gullible masses running along behind. It would be nice to see recognition of the two stages of FDA approval to date, and recognition that each physician is a qualified ethically governed agent who on relevant evidence with disclosure, can make reasonable off label use of drugs, supplements etc. (I am right now having serious second thoughts on some of the dismissals I took at far too much of face value regarding supplements, neutraceuticals and superfoods generally. Eatcher veggies etc makes even more sense.) As public policy, we need to recognise that large scale trials may be more limited and more ethically challenged than we may like to think. There are no "gold standard" yardsticks. Next, we must recognise that vaccines, the favoured trials and so forth may be too late for the full impact of this epidemic. And so we gotta fight this war with what we got in hand now. Maybe, for a decade now we should have been doing as security matters, serious investigations on antivirals and further antibiotics etc. And more. KFkairosfocus
April 17, 2020
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JT@25, you would almost think that Falwell did it for the money.
Amid those struggles, a Liberty student on Monday filed a class-action lawsuit in a federal court in Virginia, saying that Liberty and Mr. Falwell had “placed students at severe physical risk and refused to refund thousands of dollars in fees owed to them for the Spring 2020 semester,” according to a statement from the law firm filing the suit.
Ed George
April 17, 2020
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KF, I worded my original question poorly, but here's what I intended: What is not currently happening that should be happening? In other words, what specific changes should immediately be implemented?daveS
April 17, 2020
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JT states,
The people here who have actually done science are properly skeptical.
Says the man who believes, without real time empirical evidence, in Darwinian evolution. https://uncommondescent.com/intelligent-design/if-even-genes-are-into-special-creation-whats-left-for-darwinism-now/#comment-698652 Being a Darwinist is the antithesis of being 'properly skeptical'!bornagain77
April 17, 2020
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Jerry, Thanks for that background.daveS
April 17, 2020
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BTW, notice, the difference between HCL alone and in cocktails.kairosfocus
April 17, 2020
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See https://uncommondescent.com/ethics/are-double-blind-placebo-controlled-studies-the-rightful-gold-standard-so-that-whatever-does-not-measure-up-can-be-discounted-or-dismissed/kairosfocus
April 17, 2020
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From recommended reading list above - https://inference-review.com/report/therapeutic-options-for-covid-19
When the disease is detected early, there are now many other medicines that may be useful. The antimalarial and Lupus drug chloroquine, and its more potent form hydroxychloroquine (Plaquenil), have shown some efficacy. A significant number of patients that were given hydroxychloroquine, either alone or with a supplementary Z-Pak (azithromycin) to fight bacterial pneumonia, made a quick recovery. Because no sick patients were refused treatment as a control, an inhuman action by any standard, critics argue that the results were worthless. Those critics are in fact people who do not have the coronavirus. The truth is that the entire infected world of people who were not given this drug were the control. Their lengthy recovery times are the data. Hydroxychloroquine is a pleiotropic drug, a fancy way of saying it works in many mysterious ways. One primary action is that it increases the pH of lysosomes inside cells from around 4 to 6. This inhibits acidic proteases and decreases intracellular processing, glycosylation, and protein secretions. In antigen-presenting cells, this leads to a decrease in inflammatory activities. Perhaps more importantly, in other cells infected with the coronavirus, this leads to a decrease in viral loads. Hydroxychloroquine also binds to specific zinc transporters, or zinc ionophores, and keeps them open. If excess zinc is available, this presumably lets more zinc enter the cell. Zinc appears to alter the membrane permeability of lysosomes, but it has another important function. It can block the unique RNA-dependent RNA polymerase (RdRP) of the coronavirus. Although the literature calls hydroxychloroquine itself an ionophore, it only binds to the real zinc ionophores in the cell. This term is at best awkward and at worst misapplied.
jerry
April 17, 2020
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Briefly, what specific steps do you think should be taken immediately, in terms of treatment?
A teaching medical university (Eastern Virginia Medical School) has recommendations - https://www.evms.edu/media/evms_public/departments/internal_medicine/EVMS_Critical_Care_COVID-19_Protocol.pdf Prevention • Vitamin C 500 mg BID and Quercetin 250-500 mg BID • Zinc 75-100 mg/day (acetate, gluconate or picolinate). Zinc lozenges are preferred. After 1-2 months, reduce the dose to 30-50 mg/day. • Melatonin (slow release): Begin with 0.3mg and increase as tolerated to 1-2 mg at night • Vitamin D3 1000-4000 u/day (optimal dose unknown). Mildly Symptomatic patients (at home) • Vitamin C 500mg BID and Quercetin 250-500 mg BID (if available) • Zinc 75-100 mg/day • Melatonin 6-12 mg at night (the optimal dose is unknown) • Vitamin D3 1000-4000 u/day • Optional: Hydroxychloroquine 400mg BID day 1 followed by 200mg BID for 4 days Mildly Symptomatic patients on floor) • Vitamin C 500mg BID and Quercetin 250-500 mg BID (if available) • Zinc 75-100 mg/day • Melatonin 6-12 mg at night (the optimal dose is unknown) • Vitamin D3 1000-4000 u/day • Methylprednisolone 40 mg daily • Enoxaparin 40-60 mg daily • Optional: Hydroxychloroquine 400mg BID day 1 followed by 200mg BID for 4 days • Vitamin C 500mg BID and Quercetin 250-500 mg BID (if available) • Zinc 75-100 mg/day • Melatonin 6-12 mg at night (the optimal dose is unknown) • Vitamin D3 1000-4000 u/day • Optional: Hydroxychloroquine 400mg BID day 1 followed by 200mg BID for 4 days • N/C 2L /min if required (max 4 L/min; consider early t/f to ICU for escalation of care). • Avoid Nebulization and Respiratory treatments. Use “Spinhaler” or MDI and spacer if required. • Avoid non-invasive ventilation • T/f EARLY to the ICU for increasing respiratory signs/symptoms. Respiratory symptoms (SOB; hypoxia- requiring N/C ? 4 L min: admit to ICU): 1. Methylprednisolone 80 mg loading dose then 40mg q 12 hourly for at least 7 days and until transferred out of ICU. Alterative approach: Hydrocortisone 50 mg q 6 hourly. 2. Ascorbic acid (Vitamin C) 3g IV q 6 hourly for at least 7 days and/or until transferred out of ICU. Note caution with POC glucose testing (see below). 3. Full anticoagulation: Unless contraindicated we suggest FULL anticoagulation (on admission to the ICU) with enoxaparin, i.e 1 mg kg s/c q 12 hourly (dose adjust with Cr Cl < 30mls/min). Heparin is suggested with CrCl < 15 ml/min. Alternative approach: Half-dose rTPA: 25mg of tPA over 2 hours followed by a 25mg tPA infusion administered over the subsequent 22 hours, with a dose not to exceed 0.9 mg/kg followed by full anticoagulation. On transfer to floor, consider reducing enoxaparin to 40-60 mg /day. I'm sure many will laser in on optional use of HCQ. But with the success with others out there I would think it would be foolish to not take it in the doses recommended.jerry
April 17, 2020
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https://www.patheos.com/blogs/dispatches/2020/04/17/liberty-u-sees-coronavirus-outbreak/Jim Thibodeau
April 17, 2020
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@ DaveS Briefly: is having sex with a dead person 'wrong'? -Yes? - or No? (Last time you tried to avoid the question).Truthfreedom
April 17, 2020
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KF, Briefly, what specific steps do you think should be taken immediately, in terms of treatment? If you had the proverbial magic wand, what would happen today?daveS
April 17, 2020
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