Intelligent Design

Dr. Fauci and Big Farma

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Please indulge my well-earned cynicism. Let’s recap what’s been going on.

Dr. Raolt says that HCL is showing remarkable results with his CoVid patients. Dr. Raolt expands this study beyond his own clinic and patients. Dr. Fauci says that this is “anecdotal.”

A doctor in New York says that HCL, when given early on, is showing remarkable results: 80 to 90% of his patients are surviving (or, was it even higher?). Dr. Fauci says that this is “anecdotal.”

Then a study comes out that says that Remdisivir, produced by Gilead, has done a full clinical trial and that their drug lessens the time of illness from 14 days to 11 days but it only mildly improves the death rate. Dr. Fauci says: “This is significant.”

So a common drug that keeps people from dying is no more than some “anecdotal” musing. But a drug that shows mimimal improvement on death rates and recoveries is “significant.” Why such a reaction?

Well, the ‘common drug’ is dirt cheap and no big pharmeceutical company is going to make money on it. And pharmeceutical companies give money to the NIH and the CDC. I’ll let you come to a conclusion.

However, let’s be aware that big Farma is making huge money in the area of anti-viral drugs used as part of the ‘cocktail’ given HIV positive patients. Dr. Fauci has been in charge of this area for 35 years. Factor that into the conclusion you draw.

The WHO, who so ably handled themselves in this current outbreak (sarcasm alert), is responsible for introducing these highly expensive ‘anti-virals’ into Africa. It seems that whereever they found the HIV virus, these antivirals were introduced. And how did they know people had HIV? Because they tested them for antibodies to the virus. But, wait a second, when you have antibodies, that means that you’ve been exposed to the virus and fought it off, right? Isn’t this why we’re now so interested in testing people for antibodies?

So, just what kind of “science” lies at the bottom of all of this? And does the huge amount of government (and private–think Bill Gates, e.g.) money available affect, in any way, the “science” being employed.

I’d ask you to also factor these considerations into any conclusion you might reach.

51 Replies to “Dr. Fauci and Big Farma

  1. 1
    Bob O'H says:

    So a common drug that keeps people from dying is no more than some “anecdotal” musing. But a drug that shows mimimal improvement on death rates and recoveries is “significant.” Why such a reaction?

    Quality of the study. Raoult’s first study was too small to be anything more than suggestive, and his subsequent studies (and Zelenko’s) haven’t had control groups, so it’s not possible to know if they are showing that HCQ works.

    This is just basic science.

  2. 2
    jerry says:

    so it’s not possible to know if they are showing that HCQ works.

    Most definitely it is possible. Since there is no competing treatment, using published statistics will do to see if it works. Thousands of doctors are seeing patients and providing no treatment ther than ameliorating the symptoms usually with Tylenol.

    Basically HCQ or HCQ and zinc cannot do any harm. I know you will point me to the FDA and I will point you to the CDC and WHO both of whom said there was little if any potential for harm with HCQ type drugs. Then I will point you to those who have used it on several hundred patients without seeing any negatives.

    You should read this recommendation from some Harvard researchers if you haven’t already.

    We support the well-intentioned RCTs already underway in many medical centers. But tens of thousands will die before we have their results. In the meantime, anecdotal success stories, physicians’ highly personal experiences, and informal information networks are serving as the basis for widespread adoption of treatment protocols.

    https://bit.ly/3bRxuuo

    This morning I had a short conversation with a representative of one of the largest religious groups in the country and was referred to the CDC for guidance when I suggested they might help in saving lives. Essentially they did not want to get involved in any discussion that was contrary to official government policy. So I suspect that you and he would get along very well.

  3. 3
    orthomyxo says:

    s. But, wait a second, when you have antibodies, that means that you’ve been exposed to the virus and fought it off, right

    No. Basically no one “fights off” HIV, but we can develop antibodies, which keep the virus in check (The most commonly used tests also test for antigens, that is HIV encoded proteins).

    You seem to want to hark back to some good old fashioned 1980s HIV denialism, which hardly seems a useful diversion.

  4. 4
    kairosfocus says:

    BO’H: What “non-evidence” or “low quality evidence” accounts for the following from the Italians? Namely:

    Hydroxychloroquine is one of the treatments against Coronavirus being tested, and is approved by AIFA (Italian Medicines Agency). The pioneer in this field is the Director of Hematology-Oncology of Piacenza, Luigi Cavanna. It was the first in Italy to use it, an intuition that is proving significant. “Since February 25, I have treated 209 patients and in 90% of cases the response has been positive. Hospitalizations have collapsed: from 30% of hospitalized (serious or moderate cases) to less than 5% “. The change, according to Cavanna, came with the administration of hydroxychloroquine from the earliest stages of the disease, when patients were at home, and resulted in the hospitalization of very few cases in acute conditions. A treatment that, according to preliminary data collected and systematized by 5 different ASLs on 1,039 patients, is working throughout Italy.

    Or, is it that we are seeing the gold standard evidence dismissiveness fallacy I have repeatedly pointed out.

    KF

  5. 5
    PaV says:

    Bob O’H:

    Basic science? So, if you do a thorough study with relatively poor results, then the government is ready to fund it and recommend it. But, if you don’t do a thorough study–because you might not have the financial resources a major pharmeceutical company has, then your fabulous results amount to nothing. Is this the way science should work? Or, just big Farma? Follow the money!

  6. 6
    PaV says:

    Orthomyxo:

    No. Basically no one “fights off” HIV, but we can develop antibodies, which keep the virus in check (The most commonly used tests also test for antigens, that is HIV encoded proteins).

    Unfortunately, those “antigens” can be byproducts of other viruses that test positive because of the PCR technique’s limitations. No one, to my understanding, has ever written anything to dismiss Dr. Peter Duesberg’s criticism of HIV orthodoxy. Are you aware of any substantive reply?

    To go along with the HIV orthodoxy, Farr’s Law is somewhat suspended. That’s not a good starting point. CoVid-19 is not being treated in the same way as HIV: that is, if you have a number of underlying health issues and you test positive for SARS-CoV-2, then you will have died of CoVid-19.

    Here’s an intersting article.

  7. 7
    Seversky says:

    Dr. Fauci And Big Farma

    I smell a conspiracy theory.

    Please indulge my well-earned cynicism. Let’s recap what’s been going on.

    Okay, let’s do that.

    Dr. Raolt says that HCL is showing remarkable results with his CoVid patients. Dr. Raolt expands this study beyond his own clinic and patients. Dr. Fauci says that this is “anecdotal.”

    Dr Fauci was referring to the first, very small trial reported by Dr Raoult for which we only had his word at that point. That was anecdotal.

    A doctor in New York says that HCL, when given early on, is showing remarkable results: 80 to 90% of his patients are surviving (or, was it even higher?). Dr. Fauci says that this is “anecdotal.”

    Again, we only had – and still only have – Dr Zelenko’s word for how effective his treatment is.

    If you think that is enough then I have a compound, the formula for which was given to me in a vision, which will not only cure COVID-19 but the ‘flu and HIV as well. I have already tested it on over 500 patients with a success rate of over 90%. Would you like to try some?

    Then a study comes out that says that Remdisivir, produced by Gilead, has done a full clinical trial and that their drug lessens the time of illness from 14 days to 11 days but it only mildly improves the death rate. Dr. Fauci says: “This is significant.”

    Yes, the results of a “full clinical trial” are significant, more so than anecdotal reports.

    So a common drug that keeps people from dying is no more than some “anecdotal” musing. But a drug that shows mimimal improvement on death rates and recoveries is “significant.” Why such a reaction?

    Because one treatment went through a full clinical trial. The others didn’t. What’s so difficult about that?

    Well, the ‘common drug’ is dirt cheap and no big pharmeceutical company is going to make money on it. And pharmeceutical companies give money to the NIH and the CDC. I’ll let you come to a conclusion.

    Conspiracy theory. I thought so.

    However, let’s be aware that big Farma is making huge money in the area of anti-viral drugs used as part of the ‘cocktail’ given HIV positive patients. Dr. Fauci has been in charge of this area for 35 years. Factor that into the conclusion you draw.

    Has it occurred to you that whoever is first with a really effective antiviral for COVID-19 stands to make rather a lot of money? That would be a strong motive for pushing the Raoult/Zelenko treatment regimes, wouldn’t it? That’s assuming they work as claimed.

    However, let’s be aware that big Farma is making huge money in the area of anti-viral drugs used as part of the ‘cocktail’ given HIV positive patients. Dr. Fauci has been in charge of this area for 35 years. Factor that into the conclusion you draw.

    So Dr Fauci alone has been suppressing less expensive but equally effective treatments for HIV? Another conspiracy theory?

    So, just what kind of “science” lies at the bottom of all of this? And does the huge amount of government (and private–think Bill Gates, e.g.) money available affect, in any way, the “science” being employed.

    The science is in the clinical trials, which protect the vulnerable from being exploited by the well-meaning but misguided or outright charlatans and frauds.

  8. 8
    kairosfocus says:

    Sev, what is your answer to the report and described or implied officially sanctioned actions in 4 above. What do the Italians know and why does this apparently fail to be recognised this side of the North Atlantic? KF

  9. 9
    orthomyxo says:

    My god, you are a full-on HIV/AIDs denialist? I did not know such people still existed.

    The “reply” to Duesberg is the last 30+ years of research on HIV, the success of antiretrovirals in treating the disease, and the have HIV infection is the only thing routinely associated with AIDS to this day.

    Oh, and it hardly matters, but the PCR tests and antigen/antibody tests are different things. So a PCR tests is not going to discover HIV-encoded proteins in a patient’s blood.

    The idea covid-19 deaths are over-reported is basically impossible to maintain in the face of excess mortality data: https://www.nytimes.com/interactive/2020/04/28/us/coronavirus-death-toll-total.html

  10. 10
  11. 11
    Ed George says:

    PaV, did you misspell “Pharma” in the title intentionally?

  12. 12
    kairosfocus says:

    Language clue, likely

  13. 13
    daveS says:

    Perhaps an example of parallelism.

    Doctor Fauci, Big Farma.

  14. 14
    rhampton7 says:

    Big Pharma includes Novartis, does it not?

    Apr 20, 2020

    Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease. The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis.
    The large trial sponsored by Novartis will be conducted at more than a dozen sites in the United States. Novartis plans to begin enrollment for this study within the next few weeks and is committed to reporting results as soon as possible. To help achieve broad access to hydroxychloroquine as quickly as possible in these extraordinary circumstances, Novartis will make any intellectual property within our control that relates to the use of hydroxychloroquine to treat or prevent COVID-19 available through non-exclusive voluntary licenses, appropriate waivers, or similar mechanisms.

    The clinical trial complements a commitment by Novartis, through Sandoz, to donate up to 130 million tablets of hydroxychloroquine to supply global clinical research efforts in the event the medicine is proven beneficial for treatment of COVID-19. Sandoz has already donated 30 million tablets to the US Department of Health and Human Services and is dispatching futher shipments to countries based on requests from governments around the world.

  15. 15
    rhampton7 says:

    UCLA is one of seven sites participating in a clinical trial investigating whether hydroxychloroquine, a commonly used anti- malarial and autoimmune drug, can prevent infection with COVID-19, it was announced Thursday.

    The multi-site study led by the University of Washington in collaboration with six other university centers, is now enrolling 2,000 participants who are close contacts of persons who are confirmed or suspected to be infected with COVID-19. The aim is to determine whether hydroxychloroquine can prevent infection in people exposed to the virus.

    The $9.5 million trial looking at post-exposure preventive therapy for COVID-19 is part of an initiative launched by the Bill & Melinda Gates Foundation, Wellcome and Mastercard to speed development and access to therapies against the respiratory virus that has spread throughout the world. The COVID-19 Therapeutics Accelerator is funded by the three organizations and an array of government and private sector donors. The hydroxychloroquine trial is one of many approaches the group is funding.

  16. 16
    MatSpirit says:

    KF: https://aapsonline.org/aaps-letter-asking-gov-ducey-to-rescind-executive-order-concerning-hydroxychloroquine-in-covid-19/

    https://en.wikipedia.org/wiki/Association_of_American_Physicians_and_Surgeons:
    The Association of American Physicians and Surgeons (AAPS) is a politically conservative non-profit association founded in 1943. It is opposed to the Affordable Care Act and other forms of universal health insurance.

    The association is generally recognized as politically conservative or ultra-conservative, and its publication advocates a range of scientifically discredited hypotheses, including the belief that HIV does not cause AIDS, that being gay reduces life expectancy, that there is a link between abortion and breast cancer, and that there is a causal relationship between vaccines and autism.

    AAPS is generally recognized as politically conservative or ultra-conservative,[6][8] and its positions are unorthodox and at wide variance with federal health policy.[9]

    The Washington Post summarized their beliefs as “doctors should be autonomous in treating their patients — with far fewer government rules, medical quality standards, insurance coverage limits and legal penalties when they make mistakes”.[9] It opposed the Social Security Act of 1965 which established Medicare and Medicaid and encouraged member physicians to boycott Medicare and Medicaid.[10] The organization requires its members to sign a “declaration of independence” pledging that they will not work with Medicare, Medicaid, or even private insurance companies.[11]

    AAPS opposes mandated evidence-based medicine and practice guidelines, opposes abortion and over-the-counter access to emergency contraception and opposes electronic medical records.

  17. 17
    Bob O'H says:

    PaV @ 5 – there is no way you can argue Raoult doesn’t have adequate funding.

  18. 18
    kairosfocus says:

    MS,

    politically conservative — a slur at notoriously biased Wikipedia — is your answer to summary and to tabulation of results and papers? Note, kindly, this summary argument at the foot of their provisional tabulation, which is essentially about Bayesian revision of probability estimates on further evidence:

    Clinicians are natural Bayesians and such philosophical and qualitative statistical analysis is consistent with our medical training, bedside clinical skills including history taking, examination, differential diagnosis, probable primary diagnosis, laboratory evaluations including serologies, EKG, chest X-ray, CT scan of lungs, objective gold standard test interpretation and clinical decision making. In other words, waiting for fixed randomized controlled trials during a pandemic when time is of the essence, a Bayesian approach to the assessment of diagnostic and therapeutic probabilities is wise and efficient and will save time, money and lives if the physicians are given a chance to retain their autonomy and practice medicine to the best of their abilities.

    I strongly disagree with Marxists overall, but I am willing to acknowledge when they have a point.

    I am not aware of issues over vaccines and autism, but I do know these are yet another dismal tradeoff of lives vs lives as some will inevitably be hurt by vaccinations but overall significantly fewer are hurt than by epidemics. However, when there are rare diseases, the balance may well shift the other way, which is why I refused to subject my children to certain optional vaccinations. Vaccination is a dismal tradeoff issue, which may well be poorly understood or not appreciated by people afraid of or facing being on the getting hurt side. Certainly, growing up, in my neighbourhood there was a boy who was a victim of vaccinations gone wrong. In class at school I knew a polio victim who walked with a brace. I have a relative who was deafened in utero because of her mother catching German Measles. There is a needed, balanced discussion on herd immunity.

    The ability to openly have such a discussion is part of the social capital that is being squandered.

    Similarly, the basic principle of professionalism is well worth defending and the Governor clearly overstepped reasonable bounds; likely due to the precise concerns the AAPS objected to.

    As for the sales label, “evidence based medicine,” the issue is what is inside the tin.

    On that, I found the imposition of the gold standard fallacy, disregard for ethical issues that do limit the applicability of double-blind, placebo control testing [especially in the face of a fast-moving, deadly pandemic that can often kill in a couple of weeks], imposition of selectively hyperskeptical dismissiveness towards evidence that is below their bar in an imposed hierarchy . . . implying failure to understand adequacy of cumulative observations for example. As I already discussed here and here i/l/o remarks by the Guardian I responded to here. Which last also shows how allegedly gold standard tests can be deliberately set up to fail.

    And if you think that political dismissal is an adequate response, kindly explain to me this rather similar summary from Italy, courtesy GT:

    Hydroxychloroquine is one of the treatments against Coronavirus being tested, and is approved by AIFA (Italian Medicines Agency). The pioneer in this field is the Director of Hematology-Oncology of Piacenza, Luigi Cavanna. It was the first in Italy to use it, an intuition that is proving significant. “Since February 25, I have treated 209 patients and in 90% of cases the response has been positive. Hospitalizations have collapsed: from 30% of hospitalized (serious or moderate cases) to less than 5% “. The change, according to Cavanna, came with the administration of hydroxychloroquine from the earliest stages of the disease, when patients were at home, and resulted in the hospitalization of very few cases in acute conditions. A treatment that, according to preliminary data collected and systematized by 5 different ASLs on 1,039 patients, is working throughout Italy.

    Maybe, there is some actual data to be addressed on the merits?

    What do the Italians, Israelis, Indians, Turks, South Koreans, French and others know that we may need to heed the cumulative warrant for?

    KF

  19. 19
    kairosfocus says:

    BO’H: And just what is Dr Raoult’s recommendation on the cumulative impact of cases? Why is this being treated dismissively in the face of the epistemology of fairly reliable patterns and the statistics of fluctuations? KF

  20. 20
    kairosfocus says:

    F/N: Let me expand the AAPS argument:

    In addition to:

    Clinicians are natural Bayesians and such philosophical and qualitative statistical analysis is consistent with our medical training, bedside clinical skills including history taking, examination, differential diagnosis, probable primary diagnosis, laboratory evaluations including serologies, EKG, chest X-ray, CT scan of lungs, objective gold standard test interpretation and clinical decision making. In other words, waiting for fixed randomized controlled trials during a pandemic when time is of the essence, a Bayesian approach to the assessment of diagnostic and therapeutic probabilities is wise and efficient and will save time, money and lives if the physicians are given a chance to retain their autonomy and practice medicine to the best of their abilities.

    We may see:

    Likelihood ratios and Bayes’ factors cannot be
    computed yet since fixed randomized controlled trials (RCTs) are just starting around the
    world.

    A flat prior (0.5 probability where 0 is impossible and 1 is certain) could be used to
    represent one’s beliefs about whether hydroxychloroquine (HCQ) would result in clinical
    improvement and/or prevention of death from CoVID-19 based on knowledge up to
    December 2019 and January 2020. Based on the new observational studies and reports
    from several (more than 10) different medical sources in February, March and April
    2020, the prior will be updated using Bayes theorem yielding a posterior probability
    density when sufficient data to calculate likelihood ratios emerge. At present, physicians
    have a significant amount of basic science and human observational data to incorporate
    into their baseline knowledge of hydroxychloroquine safety and efficacy plus the current
    info included in this table will facilitate the physician as beliefs are updated accordingly.

    Based on the current clinical information available, the success rates for a favorable
    outcome/clinical improvement are approximately 91.6% using hydroxychloroquine
    (HCQ) [with] or without azithromycin (AZ) and/or zinc and the death rate in this treated
    group is approximately 2.7%.

    In comparison, the probability of death is 0.5-0.85 or 50 to 85% when patients with
    CoVID-19 are on mechanical ventilation and the probability of death based on Johns
    Hopkins University data worldwide is 206,544/2,971,477 or 6.95% as of 4.26.20.

    At this time, the data from 9 observational reports and one controlled trial suggest that
    hydroxychloroquine is dramatically more effective at preventing death from CoVID-19
    than mechanical ventilation. It is encouraging to note that ventilated patients treated with
    hydroxychloroquine have been able to undergo successful extubation and transfer out of
    the intensive care unit onto the floor. Moreover, CoVID-19 viral loads have been reduced
    to low or undetectable levels after 5-15 days of treatment with hydroxychloroquine.

    This puts on the table a substantial issue to be addressed. Let us do so.

    KF

    PS: My comments on Bayes and likelihood are here, in my always linked note.

  21. 21
    Bob O'H says:

    kf –

    And just what is Dr Raoult’s recommendation on the cumulative impact of cases?

    I don’t know. But that’s not relevant to whether the has the resources to do the proper trials.

  22. 22
    kairosfocus says:

    BO’H, I suspect that your proper trials are ethically challenged in several ways and are used as an excuse to suppress inconvenient evidence and a context of comparing against the natural baseline so it becomes problematic. KF

  23. 23
    Ed George says:

    KF, you keep talking about trials being ethically challenged. All trials can only be conducted with patients who have provided informed consent. They call it the “gold standard” for a reason.

  24. 24
    JVL says:

    Kairosfocus: I suspect that your proper trials are ethically challenged in several ways and are used as an excuse to suppress inconvenient evidence and a context of comparing against the natural baseline so it becomes problematic.

    Sorry, sorry, that’s just going too far.

    How, exactly do you think the trials are ethically challenged? People who participate are given complete explanations of what is being done, they are told they might get the experimental treatment or they might not, they sign waivers that say they are willing participants in the trial. I say an interview with a young woman in England who acknowledged all of that but was happy to participate in order to help make some progress. So, where are the ethics violations?

    An excuse? What evidence is being suppressed? No one is suppressing posts or publications by any of the researchers whose claims the tests are intended to check.

    The natural baseline? What does that mean? Does ‘problematic’ mean you find it problematic because you’ve already made up your mind?

    Look, some physicians have posted non-peer-reviewed statements about results they got. The world IS taking their claims seriously by taking the time to DOUBLE CHECK them with a very strong and stringent criteria because we want to be sure. Don’t we?

    You have chosen to believe the posts as you are entitled to. But that doesn’t mean they are true. So how are we, as a society, as a culture to proceed? The widely accepted and standard way is to make sure you do your best to rule out any participant or experimenter bias with a double-blind controlled study.

    There is no conspiracy. There is nothing nefarious. It’s just good scientists wanting to be sure before they get people’s hopes up and a lot of money is spent in case it turns out not to be efficacious.

    You can disagree with the methodology, that’s fine. But when you start casting aspersions on the working doctors and nurses and researchers because you think there’s some great conspiracy then you are crossing the line into the realm of agi-prop hyperskepticism.

    Check for the motes in your own eyes before you, perhaps erroneously, accuse others of having them.

  25. 25
    kairosfocus says:

    EG & JVL, let’s start with a principle attributed to Hippocrates of Cos: first, do no harm. That includes by neglecting to do good and it includes deception in the face of threat to life. Consent form fig leaves don’t make the grade in that context. There is a natural baseline treatment and there are well established techniques for comparing credible alternatives to see if they can improve that baseline. Thus, there is no need to create an artificial baseline pivoting on using randomised, known ineffective treatments in the face of a fast-moving epidemic disease that threatens life or permanent bodily harm within days. Further, to make a counsel of perfection that would likely take beyond Wave2 to achieve and to use that to undermine and dismiss cumulative evidence pointing to an increasingly credibly effective treatment readily available now is also needless harm. Though, of course, all of this is going over already covered ground. KF

    PS: I note, when it comes to the general integrity of medicine and other related professions in our day we must remember that relevant institutions are implicated in enabling the ongoing, worst holocaust in history. This indicts our governance systems in general, so with that backdrop, further, specific ethical failure points are regrettably, unsurprising.

  26. 26
    JVL says:

    Kairosfocus: let’s start with a principle attributed to Hippocrates of Cos: first, do no harm. That includes by neglecting to do good and it includes deception in the face of threat to life.

    And it includes giving treatments which have not been shown to be efficacious or safe beyond a shadow of a doubt.

    There is a natural baseline treatment and there are well established techniques for comparing credible alternatives to see if they can improve that baseline. Thus, there is no need to create an artificial baseline pivoting on using randomised, known ineffective treatments in the face of a fast-moving epidemic disease that threatens life or permanent bodily harm within days

    Too many charlatans and too many drug companies have tried to foist ineffective and sometimes harmful treatments on a trusting public. That’s why the ‘gold standard’ approach was adompted; to make sure that we are damn sure before we proscribe.

    I note, when it comes to the general integrity of medicine and other related professions in our day we must remember that relevant institutions are implicated in enabling the ongoing, worst holocaust in history. This indicts our governance systems in general, so with that backdrop, further, specific ethical failure points are regrettably, unsurprising.

    No, no, no. You cannot logically bring your questioning of the legalisation of abortion to bear on the insistence of trials which will ensure that physicians who dole out medications for a life threatening virus do no harm. For shame for casting aspersions on thousands of hardworking and caring medical care professionals because you disagree with them about abortion.

    I have tried treating you and your opinions with respect and dignity. But you are increasingly going down a rabbit hole of conspiracy theories and tunnel vision. I beseech you, in the bowels of Christ, think it possible that you may be mistaken. If you cannot contemplate that possibility then thee is no purpose for further dialogue.

  27. 27
    kairosfocus says:

    JVL:

    it includes giving treatments which have not been shown to be efficacious or safe beyond a shadow of a doubt.

    It is not in the gift of empirical, inductive investigations to prove any result of consequence “beyond a shadow of a doubt.”

    The most such could deliver is moral certainty, truth beyond responsible, reasonable doubt. However, given the notorious pessimistic induction, that immediately excludes the theoretical apparatus and theoretical frameworks of science.

    Similarly, surgery is inherently risky; that’s why hospitals make you sign off on pretty ferocious consent to risk. Likewise, for internal medicine and most prescription drugs.

    Your criterion fails, setting up a counsel of perfection that for example cannot be met by double-blind, placebo controlled studies.

    Medicine and similar learned professions, operate in the province of informed, prudent judgement. That zone in which there is irreducible uncertainty, though there can be confident conclusion in many cases. Hence, Hippocrates’ famous observation: art is long, life short, opportunity fleeting, judgement difficult.

    Tuning to the first clip in the earlier OP, I cite:

    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.

    The do no harm issue is pivotal.

    More, later, DV.

    KF

  28. 28
    Ed George says:

    KF

    EG & JVL, let’s start with a principle attributed to Hippocrates of Cos: first, do no harm.

    What harm is being done? They are sill being treated as they would if they were not in the trial. The only difference is that they may or may not receive a treatment that may or may not have an impact (positive or negative).

    Consent form fig leaves don’t make the grade in that context.

    I agree. consent forms are not sufficient. That is why they are required to demonstrate that they are in sound mind and able to make informed consent.

    There is a natural baseline treatment and there are well established techniques for comparing credible alternatives to see if they can improve that baseline.

    Yes, they are called double-blind clinical trials. The “gold standard”.

    Thus, there is no need to create an artificial baseline pivoting on using randomised, known ineffective treatments in the face of a fast-moving epidemic disease that threatens life or permanent bodily harm within days.

    There is no artificial baseline. The baseline being compared against is the routine accepted treatment. In the case of COVID-19, that involves treating the symptoms as they develop.

    Further, to make a counsel of perfection that would likely take beyond Wave2 to achieve and to use that to undermine and dismiss cumulative evidence pointing to an increasingly credibly effective treatment readily available now is also needless harm.

    Yet many medical professionals smarter than you and I have found signifiant flaws in the protocol and conclusions drawn from this “cumulative evidence”. Keep in mind, the criticism of the protocol is also evidence.

    PS: I note, when it comes to the general integrity of medicine and other related professions in our day we must remember that relevant institutions are implicated in enabling the ongoing, worst holocaust in history. This indicts our governance systems in general, so with that backdrop, further, specific ethical failure points are regrettably, unsurprising.

    Is this your version of “the sins of the father…” nonsense? My daughter recently terminated a pregnancy because there was a possible risk to her life if it proceeded. The risk was relatively low, but real. By your puritanical mores, you would conclude that she was immoral and unethical, and that all of the research conducted in that hospital is suspect.

  29. 29
    ET says:

    Any HCQ trial that doesn’t also include added zinc, is a waste of time. HCQ, by itself, is only effective if it increases your bodies Ph enough to have an effect on the ACE2’s spatial configuration. But HCQ, as an ionophore, paired with zinc should prevent the virus from replicating.

    Instead of Tylenol, hydration and rest, people need to follow the prophylaxis discussed in EVMS CRITICAL CARE COVID-19 MANAGEMENT PROTOCOL.

  30. 30
    jerry says:

    And it includes giving treatments which have not been shown to be efficacious or safe beyond a shadow of a doubt.

    Under those guidelines millions of our parents or grandparents would have died before having children. Penicillin was used without such an approach. Good thing this attitude was not around 60-70 years ago.

    All should read link in #2 above which discusses the absurdity of control tests. It is essentially saying to insist on a control test is sentencing people to death for illogical reasons. But we have lots of that here. We have harmless drugs and no alternative treatment at moment.

  31. 31
    jerry says:

    As I said on another thread maybe a million will die and can say on their death bed

    at least I didn’t get any side effects from that drug which the CDC and WHO says is harmless because they could be wrong.

    Also I am dying in the cause of not getting Trump re-elected.

    The consent form should have a section that reads, “I am willing to sacrifice my life in order that Trump not get elected.”

  32. 32
    JVL says:

    Et: It is not in the gift of empirical, inductive investigations to prove any result of consequence “beyond a shadow of a doubt.”

    Yes, I did overstate that. But we do want to be very, very sure.

    The most such could deliver is moral certainty, truth beyond responsible, reasonable doubt. However, given the notorious pessimistic induction, that immediately excludes the theoretical apparatus and theoretical frameworks of science.

    I don’t wont moral certainty, I want scientific . . . maybe not certainty but again very, very sure.

    Your criterion fails, setting up a counsel of perfection that for example cannot be met by double-blind, placebo controlled studies.

    I’m saying that we want to be at least as sure as a double-blind controlled survey. Or two or three if we can manage it.

    Medicine and similar learned professions, operate in the province of informed, prudent judgement. That zone in which there is irreducible uncertainty, though there can be confident conclusion in many cases. Hence, Hippocrates’ famous observation: art is long, life short, opportunity fleeting, judgement difficult.

    Hippocrates is not alive now and things have changed. People have been sued for not abiding by the best scientific advice.

    The do no harm issue is pivotal.

    Exactly, that’s why you want to wait until you are more sure than just taking the word of someone who hasn’t followed normal protocols or run their results by some of their colleagues to see if they stand up.

  33. 33
    kairosfocus says:

    JVL & EG, notice what you slid by as though it was not there?

    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.

    The issue of harm is described above, more than once. At this stage, you don’t get a pass for sliding by it.

    Likewise, it’s not a pardonable rhetorical flourish that makes no practical difference, the issue of the limitations of inductive, empirical warrant is pivotal. No one who truly understood its force would make a flourish like that.

    Again, do no harm.

    KF

  34. 34
    jerry says:

    I don’t wont moral certainty, I want scientific . . . maybe not certainty but again very, very sure.

    We already are very, very, very sure HCQ and zinc do not harm. We are, very, very sure that doing nothing, the current recommended treatment has led to a quarter of a million dead.

    So you must be for the immediate roll out of this drug combination to save the next quarter of million that would die in the next few weeks long before the super duper control test could be even started.

  35. 35
    kairosfocus says:

    JVL:

    >>I don’t wont moral certainty, I want scientific . . . >>

    — moral certainty regarding X is that degree of conviction of an unbiased person [yes, unbiased . . . ] that is such that on the reliable warrant in hand that X is credibly so, it would be irresponsible to act as though it were false.

    — Science, per the pessimistic induction, does not deliver any degree of certainty regarding explanatory constructs [such as theories or laws], being forever open ended to further analysis and observation.

    — facts that are observed may hold moral certainty, but that is not Scientific certainty.

    >>maybe not certainty but again very, very sure.>>

    — Kindly note the pessimistic induction on the strong track record of corrections and replacements

    — This notion that there is a one size firs all and only science that delivers gold standard knowledge is scientism, ideology not science.

    — In the relevant case, cases are recorded observations of events. In sufficient number and suitably clustered they may demonstrate the baseline and its expected range and distribution of outcomes, with room also to identify other clusters defining alternatives.

    — We may apply various techniques to evaluate that the ALT is superior to BASELINE

    — the issue is, insistence on creating an artificial baseline of administering sugar pills or the like which are disguised to look like genuine treatment. It is not hard to see the ethical issues that attach to such in a situation such as we face. Especially if that is then used to motivate a selectively hyperskeptical dismissal of evidence we do have regarding the natural baseline and alternatives

    — such becomes particularly pernicious if the artificial baseline study exposes patients to a fast moving potentially deadly disease progression, and prevents adoption of an effective treatment for the imagined epistemological failing of not using a constructed, fake treatment baseline in dealing with a potentially fatal disease.

    >>I’m saying that we want to be at least as sure as a double-blind controlled survey. Or two or three if we can manage it.>>

    — and what prevents a study on a natural baseline from being such, apart from prejudice?

    — Oh, it may be selective and unrepresentative. A sufficient study can have enough representation to be profiled against the demographics of a relevant population. In this case, we may WANT to stratify and oversample particularly vulnerable groups.

    — Oh, its observations may be sloppy. That holds for anything as the hidden crisis over replicability indicates. Besides, Raoult’s work is by a leading researcher in a first class, 2500 bed facility, with over a thousand patients.

    — Oh, there may be selection bias, those volunteering or participating may be unrepresentative. Again, this may happen with any study.

    >>Hippocrates is not alive now and things have changed.>>

    — art is long, life short, opportunity fleeting, judgement difficult is even more true today than in his day. Being about difficult judgement is actually a defining characteristic of a profession.

    >>People have been sued for not abiding by the best scientific advice.>>

    — Lawyers and defective court systems are the LAST place we should go to to evaluate issues of inductive logic, empirical warrant, ethics and sound judgement

    — Maybe, we need to be acting as the people to fix a broken legal system.

    — a natural baseline is more justified than an artificial one based on giving people facing a fast moving easily fatal disease sugar pills or the like.

    — best scientific advice hides three blunders. First, tyranny of electorally unaccountable technocrats, often unrepresentative of the full range of relevant expertise. Second, scientism and implied double standards of perceived credibility of warrant. Third, erection of unwarranted gold standard procedures

    — we need to think again.

    KF

    >>>>

  36. 36
    vividbleau says:

    To paraphrase Christine Cuomo “ if there is potential for something to work why not investigate it” “ in her blog about her and her children’s clorox baths and her $300 vitamin injections.

    Vivid

  37. 37
    JVL says:

    The US’s Food and Drug Administration (FDA) has authorised the emergency use of the Ebola drug remdesivir for treating the coronavirus.

    https://www.bbc.co.uk/news/world-us-canada-52511270

  38. 38
    JVL says:

    Structural details of how remdesivir keeps the virus from making copies of itself.

    https://arstechnica.com/science/2020/05/scientists-get-an-atomic-level-look-at-how-a-drug-blocks-the-coronavirus/

  39. 39
    JVL says:

    Researchers expressed alarm this week after the National Institutes of Health abruptly cancelled funding for a long-standing research project by US and Chinese scientists to examine how coronaviruses leap from bats to humans, potentially causing devastating pandemics—such as the one we are currently experiencing by a coronavirus genetically linked to those found in bats.

    https://arstechnica.com/science/2020/05/nih-cuts-coronavirus-funding-amid-trump-comments-and-conspiracy-theories/

  40. 40
    kairosfocus says:

    They know how to move fast when they want to.

  41. 41
    JVL says:

    Kairosfocus: They know how to move fast when they want to.

    I guess they can! This is a good thing and hopefully will take a burden off of the US healthcare system. Sadly it only seems to shorten the course of the disease. Hopefully we’ll get some other results for other treatments (HCQ, plasma, vaccines) soon. ‘Cause the best way to protect people AND the economy is to find ways to stomp COVID-19 flat.

    In case anyone is going to carp over my response . . . I hope HCQ does work! Obviously I want fewer people to die! I just want it to jump an admittedly high hurdle before I condone giving it to suffering individuals who may get better anyway (I do reserve the right to go for the hail Mary pass in the case of death looming, who wouldn’t?).

    As I’ve said on this forum before: mostly we all agree: we don’t want people to die, NO ONE (except maybe some agoraphobics) wants to live under lockdown conditions, NO ONE wants to damage the economy unrepairabley. (Can’t get the spell-checker to ‘like’ that or some other obvious variations . . . maybe it’s not an accepted word?) We disagree on some lines in the sand, i.e. we draw them in different places and that’s the stuff we need to negotiate and compromise over. Like civilised people.

    The economy matters, lives matter, getting medical interventions that help matters. Let’s discuss some specifics about where we differ instead of the overall values upon which we agree.

  42. 42
    Latemarch says:

    All:
    Recent summary article on the use of hydroxychloroquine.
    Pseudo-science Behind the Assault on Hydroxycholorquine

  43. 43
    kairosfocus says:

    LM,

    Let me clip Goldstein’s summary (which will sound familiar):

    Summary

    I reviewed the scientific literature on hydroxychloroquine (HCQ), azithromycin (AZ), and their use for COVID-19. My conclusions:

    HCQ-based treatments are effective in treating COVID-19, unless started too late.
    Studies, cited in opposition, have been misinterpreted, invalid, or worse.
    HCQ and AZ are some of the most tested and safest prescription drugs.

    Severe COVID-19 frequently causes cardiac effects, including heart arrhythmia. QTc prolonging drugs might amplify this tendency. Millions of people regularly take drugs having strong QTc prolongation effect, and neither FDA nor CDC bother to warn them. HCQ+AZ combination, probably has a mild QTc prolongation effect. Concerns over its negative effects, however minor, can be addressed by respecting contra-indications.
    Effectiveness of HCQ-based treatment for COVID-19 is hampered by conditions that are presented as precautions, delaying the onset of treatment. For examples, some states require that COVID-19 patients be treated with HCQ exclusively in hospital settings.
    The COVID-19 Treatment Panel of NIH evaded disclosure of the massive financial links of its members to Gilead Sciences, the manufacturer of a competing drug remdesivir. Among those who failed to disclose such links are 2 out of 3 of its co-chairs.
    Despite all the attempts by certain authorities to prevent COVID-19 treatment with HCQ and HCQ+AZ, both components are approved by FDA, and doctors can prescribe them for COVID-19.

    KF

  44. 44
    jerry says:

    Good news from the Houston nursing home using Zelenko’s protocol https://bit.ly/3d9rU6F

    FOX 26 gets unprecedented access to Texas’ 1st nursing home to treat COVID-19 with Hydroxychloroquine

    There are now multiple treatments appearing. HCQ, zinc and Azithromycin is one but there are others. Remdesivir is another that involves. the interruption of the virus from replicating. There are plasma treatments with promising results. Another is Leronlimab.

    The gold standard at the moment is the HCQ, zinc, Azithromycin and controlled studies should be comparing this to other treatments. One problem is that some of the others are extremely expensive and require in hospital treatment or a center that can administer drugs by IV,

    For medical misinformation on HCQ see https://bit.ly/2VRCrxB

    Of course for misinformation or bad information or bad interpretation on HCQ, there is always some on UD that will provide it or lead one to it.

  45. 45
    kairosfocus says:

    Jerry, verry interesting. KF

  46. 46
    rhampton7 says:

    instead of trying to develop new drugs to work on these points of interaction, we turned to the more than 2,000 unique drugs already approved by the FDA for human use.

    A month ago, we began shipping boxes of these drugs off to Institut Pasteur in Paris and Mount Sinai in New York to see if they do in fact fight the coronavirus.
    In the last four weeks, we have tested 47 of these drugs and compounds in the lab against live coronavirus. I’m happy to report we’ve identified some strong treatment leads and identified two separate mechanisms for how these drugs affect SARS-CoV-2 infection.

    we noticed that several viral proteins interacted with human proteins involved in translation and a number of drugs interacted with these proteins. After testing them, we found two compounds that disrupt the translation of the virus.

    The two compounds are called ternatin-4 and zotatifin. Both of these are currently used to treat multiple myeloma and seem to fight COVID-19 by binding to and inhibiting proteins in the cell that are needed for translation.

    Our original map identified two promising MV cell receptors for drug treatments, SigmaR1 and SigmaR2. Testing confirmed our suspicions. We identified seven drugs or molecules that interact with these receptors.

    At this time we do not know exactly how the viral proteins manipulate the SigmaR1 and SigmaR2 receptors. We think the virus uses these receptors to help make copies of itself, so decreasing their activity likely inhibits replication and reduces infection.

    Another interesting thing to note is that hydroxychloroquine – the controversial drug that has shown mixed results in treating COVID-19 – also binds to the SigmaR1 and SigmaR2 receptors. But based on our experiments in both labs, we do not think hydroxychloroquine binds to them efficiently.

  47. 47
    Bob O'H says:

    rhampton7 – could you link to your sources, please. It’s not always clear if you’re quoting someone else, or writing your own material.

  48. 48
    kairosfocus says:

    RH7, of course, HCQ, Azithromycin and Zn are credibly synergistic, with multiple proposed or known in part mechanisms. That aspect is also key as it will make drug resistance a difficult target in the space of possibilities. We have to shift to a MIMO, time varying systems thinking paradigm. KF

  49. 49
    jerry says:

    could you link to your sources, please. It’s not always clear if you’re quoting someone else, or writing your own material.

    RHamptom apparently just cuts and pastes. The study was published in Nature

    https://go.nature.com/2z9GXOT

    The study was discussed here

    https://bit.ly/2z2oEv6

    The more the better and the faster. Also the cheaper the better if there is little difference between effective treatments because it has to be scaled up for the world.

  50. 50
    jerry says:

    As far as I can determine, zinc was not tested. The word zinc was mentioned three times in the nature article but two refer to a data base of molecules and once to a vague use in chemical terms. If anyone has any other information, please publish it.

  51. 51
    PaV says:

    KF:

    I looked to see if the article I was about to post was already linked here. It isn’t, but the important part of it is @43. But in the article I was going to post, there’s also a part about Gilead and the NIH.

    As they say: Q.E.D.

    Here’s an article from April 23rd on Gilead. (This came a week before I posted)

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