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Are double-blind placebo-controlled studies the rightful “gold standard”? (So that, whatever does not “measure up” can be discounted or dismissed?)

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As we have seen in recent weeks as Covid-19 and Hydrochloroquine cocktail treatments have been on the table, there is a clear tendency to view and treat double-blind placebo controlled testing as a “gold standard” yardstick and to then use such to discount and dismiss whatever does not “measure up” such as Professor Raoult’s work over in France. I will now argue in outline that such an attitude is selectively hyperskeptical, seriously ethically, epistemologically and logically flawed, and sets up a crooked yardstick.

It is a commonplace in Medical research that arguably more lives were saved, net, than perished through the tainted medical studies in the Nazi death camps. However, the taint was seen as so serious that a programme of studies was undertaken over a full generation to replicate then replace the tainted warrant. For, when human souls, lives, health and well-being are on the line, scientific research becomes particularly subject to ethical considerations.

That’s why we may observe a 2013 paper:

The Ethics of Placebo-controlled Trials: Methodological Justifications

Joseph Millum, Ph.D.a,b and Christine Grady, R.N., Ph.D.a

Abstract

The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling.

We instantly see, that placebo control groups are problematic ethically when harm may come to patients because they are given a sugar pill instead of an active drug that is credible enough to be used in the [usually quite expensive trials]. Where, we are not going to be taking up such trials for trivial treatments.

Further to this, there is a sop to the conscience, of having those who give out pills that may be misleadingly labelled, ignorant as to whether the particular pills are active or not. But, there is a record that is being taken. That is, calculated deception and potential for harm are part of the experimental design, an undermining of the fundamental ethical plank of the platform of the medical and nursing profession.

(Mind you, in a day when about a million further victims of the ongoing holocaust of our living posterity in the womb are totted up per week, consciences are doubtless benumbed.)

So, already, there is a general ethical problem, one exacerbated by the principle that to be issued a duly labelled medication by a suitably recognised professional bound under Hippocratic principles, is to have a legitimate expectation of serious treatment. Indeed, that is the foundation of the so-called placebo effect.

In the context of the trials in view regarding drugs for the Covid-19 pandemic, we face a disease that can and too often does seriously harm or kill in a matter of days once symptoms become evident. Further, there is a general challenge to find broadly accepted clinically effective antivirals. However, HCQ and CQ have been noted on record since 2005, as having in vitro effect on a broad range of viruses and as J. Scott Turner reports in Inference Review:

Chloroquine (CQ) and hydroxychloroquine (HCQ) are showing promise as therapeutic treatments for COVID-19 infections. These drugs are widely used for the treatment of malaria, and their use against COVID-19 was a source of some controversy in the early stages of the current pandemic. Nevertheless, the FDA has recently given emergency approval to what had long been a common off-use application for treatment of viral infections. This approval was granted in light of a long history of using CQ and HCQ as antiviral drugs, including during past coronavirus epidemics. Furthermore, informal reports coming from emergency and critical care clinics indicate they are effective against COVID-19, particularly when combined with antiviral agents and antibiotics . . . .

When it came to treating COVID-19, the concern was that this off-use of HCQ posed an unknown risk to patients already at high risk from the viral infection. The debate missed two important points. First, the ad hoc use of CQ and HCQ as antiviral drugs has a history going back nearly forty years, including in the last major coronavirus pandemic of 2002–2003 known as SARS, for Severe Acute Respiratory Syndrome. Second, no one really understands why the quinine family of alkaloids is an effective treatment for malaria.4 For that matter, nobody really understands why CQ and HCQ are effective agents against coronavirus. If this were not enough, CQ and HCQ have also been shown to be effective in a broad spectrum of disorders, including several autoimmune diseases such as lupus and rheumatoid arthritis, diabetes, blood clotting disorders, lymphoma and other blood cancers, and sensory neuropathy. Nobody really understands why CQ and HCQ are effective therapeutic agents for these disorders either.

We have in hand, thousands of cases that support the claim that HCQ (especially in a cocktail) has significant potential to counter Covid-19, and there are several proposed mechanisms, some of which may be acting in concert. One cannot simply dismiss that as though it did not exist. Especially, when we can note the following approval for Dr Raoult’s work:

Research protocol approved by the ANSM and the Île-de-France CPP in progress at the IHU Méditerranée Infection: Treatment of respiratory infections with Coronavirus SARS-Cov2 by hydroxychloroquine Acronym: SARS-CoV2quine.”

Where, further, the following chart appears in his Institute’s site:

[Their Caption:] Percentage of patients with PCR-positive nasopharyngeal samples from inclusion to day6 post-inclusion in COVID-19 patients treated with hydroxychloroquine only, in COVID-19 patients treated with hydroxychloroquine and azithomycin combination, and in COVID-19 control patients.

To produce such a chart, of course, considerable experimental work and analysis had to be done. What it shows is a strong reduction in patients with a virus load, implying steady diminution with the Cocktail and less effect with HCL only. That is supported by the onward 80 patient trial and the cumulative 2,759 result:

This seems to document a significant impact on fatality rate and it supports the pattern in the above chart. Where, obviously, we are in a situation of having a respectable number of cases.

Is this result definitive and beyond amendment in light of further results? No, that is never the case for empirical findings. Indeed, strictly, any empirical result could come about by coincidence.

But, that’s not the smart way to bet:

We can observe that we share a common humanity, with fairly similar physiology and biochemistry. Indeed, we overlap with many other life forms. So, if we can find consistent patterns, we are entitled to take them as signs of an underlying mechanism at work. Even, when we do not fully understand it.

In that context, all reasonable evidence counts.

Yes, sometimes a double-blind placebo study is justified (or even if not, has been done). Its results will be best explained on efficacy of a treatment, if successful. But we cannot properly draw a datum line to exclude other empirical evidence, to do so would be to resort to a crooked yardstick.

In our present situation, we do not have the luxury of a year as has been suggested for studies and for vaccines. We have a deadly disease now, a fast-acting one. With a potential treatment by cocktail that seems more effective than HCL alone or other alternatives. Since the drug is a known factor for decades, and as side effects are manageable, it seems that there is warrant to try it, under physician control, and to try it in good enough time to avert complications.

Of course, it is not certain, but this is the strong horse at the moment. Until/unless it is beaten, let us be willing to respect that. END

29 Replies to “Are double-blind placebo-controlled studies the rightful “gold standard”? (So that, whatever does not “measure up” can be discounted or dismissed?)

  1. 1
    kairosfocus says:

    Are double-blind placebo-controlled studies the rightful “gold standard”? (So that, whatever does not “measure up” can be discounted or dismissed?)

    What of HCL Cocktails?

  2. 2
    jerry says:

    What of HCL Cocktails?

    It was over 2 weeks ago we were discussing Zelenko. How soon we forget.

  3. 3
    kairosfocus says:

    Zelenko is part of what is being dismissed.

  4. 4
  5. 5
    kairosfocus says:

    JT,

    This is part of why I have written as I have in the OP:

    The French doctor Didier Raoult has claimed [–> has reported, on now almost 3,000 patients, under a test protocol approved by relevant authorities] the combination is a cure, leading to public clamour for the drugs in France. [–> Actually, after the 80 patient test, there was an initial approval in France, and a second level in the US] President Macron visited Raoult’s hospital in Marseille last week, giving him tentative support but suggesting that trials [–> not, further trials, i.e. precisely the dismissiveness that is not warranted] were needed . . . . hydroxychloroquine and azithromycin are being tested separately [–> have they heard of synergy? The results in hand point to synergy. And where is the Zn?] as part of the Recovery trial, and if there is any effect in patients given those drugs alone [–> so, you load in lack of effect at the design phase], compared with those given no drugs [–> in the face of a fast-acting deadly disease, given deliberately mislabelled sugar pills], they can be combined later. [–> as synergy is clearly involved on tests and cases in hand, this boils down to loading the dice against a result not wanted, based on locking out evidence in hand willfully ignored]

    For now, said Horby, the data flying around in emails from enthusiasts and posted on social media [–> deliberately misreprresents results and context in hand, refusing to acknowledge Dr Didier Raoult, i.e. classic no true Sassenach] about patients who have recovered after taking hydroxychloroquine proves [–> inductive evidence never amounts to proof, but may provide good cogency] nothing. He says there is no real evidence [–> Classic no true Sassenach, and selective hyperskeptical dismissal] to support its use yet.

    In short, here we see the precise problems identified in the OP. And besides, I think in S Dakota tests of 100,000 are beginning.

    KF

    PS: Here is a classic pre-emptive remark by a true Sassenach:

    [Essay on Human Understanding, Intro, Sec 5:] Men have reason to be well satisfied with what God hath thought fit for them, since he hath given them (as St. Peter says [NB: i.e. 2 Pet 1:2 – 4]) pana pros zoen kaieusebeian, whatsoever is necessary for the conveniences of life and information of virtue; and has put within the reach of their discovery, the comfortable provision for this life, and the way that leads to a better. How short soever their knowledge may come of an universal or perfect comprehension of whatsoever is, it yet secures their great concernments [Prov 1: 1 – 7], that they have light enough to lead them to the knowledge of their Maker, and the sight of their own duties [cf Rom 1 – 2, Ac 17, etc, etc]. Men may find matter sufficient to busy their heads, and employ their hands with variety, delight, and satisfaction, if they will not boldly quarrel with their own constitution, and throw away the blessings their hands are filled with, because they are not big enough to grasp everything . . . It will be no excuse to an idle and untoward servant [Matt 24:42 – 51], who would not attend his business by candle light, to plead that he had not broad sunshine. The Candle that is set up in us [Prov 20:27] shines bright enough for all our purposes . . . If we will disbelieve everything, because we cannot certainly know all things, we shall do muchwhat as wisely as he who would not use his legs, but sit still and perish, because he had no wings to fly.

  6. 6
    rhampton7 says:

    Much of the news coverage has come as a result of two studies by one French group. These compared patients with Covid-19 receiving hydroxychloroquine (with or without an antibiotic called azithromycin) with those receiving standard care. The conclusion drawn from these studies was that hydroxychloroquine, alone or with the antibiotic, can reduce the number of patients testing positive for the virus.

    Both these studies have been closely scrutinised and issues have been raised about how they were designed and carried out. For the results of a trial to be reliable, the researchers need to be sure that any differences seen in the outcome are only due to the treatment received. This means that there needs to be a control group to compare to – for example, a similar group of patients not receiving the treatment. Randomly assigning participants to each of these groups is the best way of ensuring that the results of trials are not biased by the way people in each group are selected.

    In the first smaller study there was a control group, but this group was not randomly selected. In addition, not all of the 26 patients who received hydroxychloroquine were included in the analysis of the results, despite the fact one died, three were admitted to intensive care and one stopped the treatment. All in all, we can’t be sure that any difference seen between these groups is actually due to the treatment. The study is?now also being investigated by the publisher of the journal it appeared in.

    The second slightly larger study of 80 patients has not?yet even been formally reviewed by other scientists or doctors. But similar concerns have been raised about the lack of appropriate controls and randomisation. It’s also not clear whether the outcomes that were measured, such as whether virus can be detected in nasal swabs, have a direct relevance to patients in terms of their illness and recovery. And as both studies are small, their findings can only generate more questions rather than answer them.

    Dr Sonya Babu-Narayan, BHF Associate Medical Director, said:

    “At the moment in the UK, hydroxychloroquine is not being prescribed for Covid-19 outside of clinical trials. If the ongoing trials do show a benefit, it is clear that there will need to be further consideration of its potential side effects on the heart and blood vessels, and systems in place to ensure that these risks are minimised. For example, screening with an electrocardiogram to prevent the drug from being given to patients at the greatest risk of a cardiac event so alternatives can be considered or closer monitoring for those that need it.”

  7. 7
    rhampton7 says:

    There are now dozens of studies worldwide involving people with Covid-19 infection being treated with hydroxychloroquine, either under way or being set up. This includes 3 large trials recruiting suitable participants from certain UK hospitals or GP practices:

    RECOVERY – testing a range of treatments including hydroxychloroquine for people hospitalised with Covid-19 infection

    REMAPCAP – testing a range of treatments including hydroxychloroquine for people admitted to intensive care with pneumonia (including that linked to Covid-19)

    PRINCIPLE – a trial recruiting people via their GP, testing hydroxychloroquine for people with suspected coronavirus infection who are thought to be at higher risk of severe complications (aged 50 years and above with pre-existing conditions, or 65 years and above)

    These randomised controlled trials, and others like them around the world, will provide valuable information for or against the wider scale use of this drug. In addition, these studies could also reveal if there are specific groups of patients who may benefit most from taking hydroxychloroquine for this purpose.

  8. 8
    kairosfocus says:

    RH7, as Jerry pointed out long since, there is an obvious, massive “control group,” the general pattern of the disease as seen by clinicians. Here at UD, we put up a summary by a NO ER doctor. That is, the reason why HCQ and cocktails drew attention was, they made a difference, one which has been documented. In that context, the impacts of various treatments can be recognised from case studies, or if you will, studies following the principle of ANOVA, treatments and plots allowing slicing and dicing of patterns of variance. But more to the point, despite how we have been trained to think, evidence does not just come in the form of control group experimental designs, and that is important as there are circumstances where such designs would take too long (and when coupled to their temptation to ignore, denigrate and dismiss other evidence become an invitation to pernicious error). Likewise, in contexts where life, health and well-being are on the line, the temptation to ignore responsible alternatives becomes a violation of the do no harm principle, starting with calculated deception and linked putting people at needless risk of dying or suffering serious damage to vital organs in a matter of days given a fast-moving disease. Oh yes, notice my markup of the Guardian report, especially on how ignoring evidence on the table about synergy will likely undermine the relevance of the studies in prospect. Where, I distinctly recall spending years taking multiple drug treatments as a child, i.e. synergy of drugs is no novelty. We need to do some serious rethinking. KF

  9. 9
    rhampton7 says:

    Cautionary tales also have emerged from Brazil and Sweden on the use of chloroquine and hydroxychloroquine in patients with cardiovascular disease (CVD). In Sweden, where social distancing is not mandatory, clinicians were instructed last week to not use chloroquine among patients with COVID-19 unless they are part of a clinical trial.

    Magnus Gisslén, professor and senior doctor at the Sahlgrenska University Hospital in Gothenburg, Sweden, and colleagues noted “a serious effect on the heart” linked to using the medication, as well as that “the patients most at risk are those with pre-existing conditions in the heart. Those are often the older patients,” he said. “But if you get a too high dosage it can affect people who have no underlying conditions at all.”

  10. 10
    kairosfocus says:

    RH7, yes, and such preconditions will be known to prescribing physicians as part of the routine. How many meds have advisories? A lot. KF

  11. 11
    rhampton7 says:

    In the words of San Diego physician Jennings Staley, the drug hydroxychloroquine?, approved to treat conditions ranging from malaria to lupus, was “almost too good to be true.”

    On his website advertising the product, Staley — whose practice includes Botox injections, tattoo removal, oxygen therapy, and fat transfer — cited President Donald Trump’s recent promotion of a French study claiming hydroxychloroquine had overwhelmingly positive results in the fight against Covid-19?, according to federal prosecutors.

    ?The complaint says that Staley admitted to investigators that he distributes ?Covid-19 kits through his website and said he imports his hydroxychloroquine from China, but indicated it was “perfectly legal” and “goes through customs.”

    The doctor’s criminal charge comes as Justice Department prosecutors and FBI agents aggressively seek out scammers who are using the coronavirus pandemic to defraud the public through various testing and treatment schemes.

  12. 12
    kairosfocus says:

    RH7, what is the charge? Importing without authorisation? Or, is it accusation of selling snake oil? If the latter, it will predictably fail. KF

  13. 13
    rhampton7 says:

    Dr. Jennings Ryan Staley, 44, has been charged with one count of mail fraud after he claimed falsely his treatment would eliminate the virus “in hours” and even render as many as six weeks immunity to the novel coronavirus, NBC San Diego reported.

  14. 14
    Jim Thibodeau says:

    Violations of 21 U.S. Code §841, i would think. But i am not a lawyer.

  15. 15
    kairosfocus says:

    RH7, that sounds like exaggerated claims, which is substantially distinct from actual consistent performance of HCQ-based cocktails. Of course, in the current deeply polarised media climate, suitable headlining can then be used to create an aura of taint. What I have found interesting in all of this, is how Dr Raoult is framed as opposed to Dr Fauci. It would be hard to recognise from portrayals such as in the Guardian, that we are dealing with an eminent, renowned researcher who heads a major Institute. That speaks, volumes. KF

  16. 16
    kairosfocus says:

    F/N:

    I am also thinking back to the old “Scientific Method” summary we were taught in schools and its roots in Newton’s Opticks, Query 31:

    As in Mathematicks, so in Natural Philosophy, the Investigation of difficult Things by the Method of Analysis, ought ever to precede the Method of Composition. This Analysis consists in making Experiments and Observations, and in drawing general Conclusions from them by Induction, and admitting of no Objections against the Conclusions, but such as are taken from Experiments, or other certain Truths. For [speculative, empirically ungrounded] Hypotheses are not to be regarded in experimental Philosophy. And although the arguing from Experiments and Observations by Induction be no Demonstration of general Conclusions; yet it is the best way of arguing which the Nature of Things admits of, and may be looked upon as so much the stronger, by how much the Induction is more general. And if no Exception occur from Phaenomena, the Conclusion may be pronounced generally. But if at any time afterwards any Exception shall occur from Experiments, it may then begin to be pronounced with such Exceptions as occur. [–> this for instance speaks to how Newtonian Dynamics works well for the large, slow moving bodies case, but is now limited by relativity and quantum findings] By this way of Analysis we may proceed from Compounds to Ingredients, and from Motions to the Forces producing them; and in general, from Effects to their Causes, and from particular Causes to more general ones, till the Argument end in the most general. This is the Method of Analysis: And the Synthesis consists in assuming the Causes discover’d, and establish’d as Principles, and by them explaining the Phaenomena proceeding from them, and proving [= testing, the older sense of “prove” . . . i.e. he anticipates Lakatos on progressive vs degenerative research programmes and the pivotal importance of predictive success of the dynamic models in our theories in establishing empirical reliability, thus trustworthiness and utility] the Explanations. [Newton in Opticks, 1704, Query 31, emphases and notes added]

    Now, obviously, case-based, reliability driven, insightful inference to best current explanation oriented inductive investigations and reasoning are much broader than the conventionally labelled sciences. That’s a piece of why there is no one size fits all and only Big-S “Science” method. But it is undeniably powerful and when properly done, useful.

    My favoured summary (honouring a favourite student) is O, HI PET:

    O — OBSERVE a situation (looking at key factors, facts, trends, relationships, family resemblances etc, the intent being to accurately describe, effectively and reliably explain, reliably predict patterns, and use these to influence or control fresh situations)

    H –HYPOTHESISE . . . infer an evident pattern (looking for reliable, best current explanatory frameworks)

    I & P — INFER & PREDICT . . . what consequences would follow in fresh circumstances (an empirically reliable principle, rule, explanatory framework, law, model or theory — or entity embedding such — is highly valuable . . . including a new instrument, device, gadget, process, procedure or treatment embedding such)

    ET — EMPIRICAL TESTING . . . we need to identify then disseminate successful, reliable, effective, insightful, fruitful results

    Now, let’s state the needed obvious: nothing in this framework mandates double-blind, placebo control group procedure.

    Indeed, it points to the underlying principle of case-based reliable inference. Where control groups can ethically and effectively be deliberately set up and used, fine. But that is by no means always the case, with Astronomy perhaps the capital example as a sub-discipline that uses case-based observational studies as a part of the hardest of the hard sciences, Physics. There is a reason why we speak of Astronomical OBSERV-atories, not LABOR-atories. (Ditto for Volcanology; and that was the pivot of my public warning here, 25 years ago. Looong story.)

    In short, we must be humble enough to recognise that we cannot prescribe an investigative panacea.

    Linked, we may ask, how does this work?

    First, by applying the principle of distinct identity. A is A i/l/o its key characteristics, some in common with near and increasingly distant neighbours, some more specific to its class then ultimately to itself as a particular case. Where, core characteristics give rise to repeatable patterns of behaviour in sufficiently similar situations.

    Thus, the art of scientific and broader empirical investigations is to seek sufficiently reliable candidate characteristics- in- common for a broad enough class of cases or entities. This then can be tested for reliability through further studies, whether experimental, observational, predictive or “retrodictive” etc. Such, can then be accepted as a provisional, promising explanatory model, which at the high end will be a theory [i.e. an explanatory model that is felt to be possibly true; models may be deliberately simplified . . . so necessarily false, but useful].

    Again, nothing in this imposes placebo control groups as a necessary criterion of validity or reliability. And, contrasted cases studied in matched pairs or clusters with variances points to a broad framework for statistical studies, ANOVA and its various extensions.

    But even that is not a straightjacket, various forms of exploratory data analysis and scientific visualisation have often been powerful. Modelling- and- simulation exercises (often with computer animations and Monte Carlo explorations of contingencies) have joined such in recent years. Taxonomical studies have been fruitful, e.g. in Biology. So can be simple tabulation, with the periodic table being perhaps the classic case in point. That brings up, familiarity with epochal cases, the paradigms that set up new schools of thought and launch research programmes.

    But, such programmes are almost never “proved” — in Lakatos’ terms, they are born, live and die “refuted” by anomalies, counter-examples, challenges, exceptions, open questions etc. But a progressive research programme advances through successive predictive success, and a regressive one falters and wanders off into becoming increasingly ad hoc and/or simplistic and restricted. If institutionalised in power centres, a degenerative programme can stave off competitors for many years, but eventually, the bills come due with nothing to cover them.

    All of this sounds rather political and ideological, doubtless. (Economics is perhaps the capital example.)

    Yes.

    We are social creatures and power- with- linked- wealth is always a consideration. Which is why issues of corruption are always lurking as a dirty secret in Science; including, on what may go on behind the scenes of peer review. Likewise, we see the challenge . . . or, is that now, crisis? . . . of testing and reliable replicability.

    Coming back to our immediate focus, it is obvious that urgency here undermines the relevance of placebo controlled studies, even were one to set aside the issue that first the physician must do no harm. Where, sugar pills deliberately administered to patients facing a fast acting, potentially deadly disease pose fairly obvious ethical challenges. So, we need to go to deeper investigatory principles, to identify what is a more relevant approach to a pandemic in progress.

    The answer comes back, repeated, case based clinical studies using suitable candidates reflecting the state of our knowledge. Which is precisely what Prof Raoult has been doing. 2759 cases reflects Stalin’s principle: sufficiently massive quantity has a quality all of its own.*

    KF

    *PS: That’s so here because in this context, beyond a certain mass of cases that sufficiently contrast with the general background, errors of coincidence are not a credible candidate null explanation. If there is a 10 percent chance of error, and, we see 100 independent cases that trend is unlikely to be chance. The chance that a string of errors that long falls exponentially. 0.1^100 is 10^-100. If the die keeps coming up sixes 100 times, or the coin comes up H 100 times in a row, loading becomes the best explanation. Which is of course the basic point in classic hypothesis testing in statistics.

  17. 17
    kairosfocus says:

    test, let me try to insert an image

    Lessee if this works.

    –> Nope, it is stripped out.

  18. 18
    Bob O'H says:

    kf you’re so enamored of that chart, but can you also add the clinical effectiveness to it, i.e. what proportion in each arm of the treatment went to the ICU, and died. Those figures tell a rather different story.

  19. 19
    Bob O'H says:

    kf @ 8 –

    RH7, as Jerry pointed out long since, there is an obvious, massive “control group,” the general pattern of the disease as seen by clinicians.

    That’s true, but one has to be careful with the raw figures. If (for example) HCQ was being used in areas with a higher proportion of people over 70 years old, it would show up as being worse, even if it was effective. These confounding factors need to be controlled for. This sort of study (a “retrospective study”) has been done, and the title summarises the results: “No evidence of clinical efficacy of hydroxychloroquine in patients hospitalized for COVID-19 infection with oxygen requirement”.

  20. 20
    kairosfocus says:

    BO’H: the chart documents a crucial divergence of trends with differing treatments. Your emotive appeal dismissiveness does not answer to it or to the tabulated divergence in results across 2759 cases (11 deaths) vs 4420 cases (85 deaths) that appears just below. Something very different happened at IHU, on the obvious proportions and it has somewhat to do with the use of HCL and Azithromycin cocktails as the chart you at last comment on, though predictably superficially and dismissively, speaks to. What Raoult reports is not “anecdotes” or “no evidence” or “touting” etc etc, he is laying out comparative cases, backed by contrasted outcomes and linked studies of the chemical action at relevant concentrations. My concern is not, at this point, FDA’s policy response of approving an increased level of use just after Raoult’s 80 patient study, it is the problem of selective hyperskepticism and promotion of ethically questionable experiment designs as gold standards such that — as I have now separately headlined — there is a tendency to dismiss what does not conform to what has clearly been bent into a crooked yardstick. And such is of course closely connected to a major concern here at UD over the past decade. KF

    PS: As you know, case studies . . . especially when sufficient mass is present — can be demographically clustered, a common practice. Indeed, earlier, there was such a cluster chart put up, showing how in the top right corner, older populations lead to higher numbers of deaths and rates of death.

  21. 21
    Bob O'H says:

    kf – you’re igoring my point. In the study that that figure is from, all of the patients who went to the ICU, and all of the deaths were in the HCQ group. How are you going to explain HCQ is an effective treatment, when in this trial the clinical endpoints show this difference?

    (for those following along, my point isn’t that this study shows that HCQ is worse, rather that you can’t cherry-pick your evidence)

  22. 22
    kairosfocus says:

    BO’H: Kindly observe local and broader context, e.g. as is tabulated in the OP above regarding IHU and APHM, a comparative yielding APHM, 4420 patients (85 deaths), IHU 2759 patients (11 deaths). KF

  23. 23
    Bob O'H says:

    I’m sorry kf, can you re-write comment 22 so that it’s understandable. For a start, it might be worth explaining what IHU and APHM are, and then explain what the statistics are meant to show.

  24. 24
    kairosfocus says:

    BO’H, if you don’t understand it’s because you did not see the tabulation in the OP from Raoult, on cases treated and compared. 85:4420 = 1.92% and 11:2759 = 0.399%, a clearly material difference in case fatality rates, with sufficient scale of study to carry weight. Notice, the overall cluster shows a contrast in outcomes, with IHU pulling up overall performance as it is above the average. KF

  25. 25
    Bob O'H says:

    kf – I did see it. But without knowing what IHU and APHM are, it’s uninformative.

    Please, if you want to use evidence to make a point, provide the evidence and a sufficient explanation of what it means so that we can follow your train of logic from the evidence to the point you are trying to make.

  26. 26
    kairosfocus says:

    BO’H: The links are there, though you will need to deal with French. KF

    PS: AP-HM is Assistance Publique-Hopitaux de Marseille — the teaching hospital bloc [4 hospitals, 3400 beds . . . the French love to centralise!] working with DR and IHU is his particular one of a class of research centres for Medicine in France, here tied to DR’s University. .

  27. 27
    jerry says:

    Zelenko is up to 1450 C19 patients and only 2 dying. One from cancer.

  28. 28
    Bob O'H says:

    Wow, kf, you really don’t want to make your point do you?

  29. 29
    kairosfocus says:

    BO’H, really. The immediate point is that Dr Raoult has carried out a trial on nearly 3,000 patients, under protocols approved by the relevant French agencies, in association with a cluster of four hospitals in S France, and has ended up with about 1/5 the death rate of the overall set of 4000 + patients (apparently including his own, i.e. the 85 deaths from 4420 patients seems to be an improved average pulled that low by the superior performance of the HCQ cocktail). This striking result — due to the gold standard fallacy I have been pointing out — is being routinely belittled, trashed and disregarded, leading to dismissal of significant clinical evidence that HCQ cocktails work. Therefore, as I have gone on to address, the gold standard fallacy is evidently harmful and distorts policy analysis and action. KF

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