Category: Observational Study

The Meta-Analytical Fixers: An Ivermectin Tale – The Chloroquine Wars Part XL

The Roman/Hernandez meta-analysis comes at a politically contentious moment. Their language and behavior appear political. Their work is error-laden, takes research out of its true context, uses numbers that don’t seem to come from the actual studies, chooses papers testing ivermectin under the least favorable circumstances, gives unexplained and inappropriate weights to the small amount of data that stands as outliers to the bigger picture, and still drives a conclusion of “don’t use this” from a massive average mortality reduction that did not quite reach statistical significance. At the same time the authors consistently complain about the “low quality of evidence” represented by the studies they do and do not include, nearly all of which I would describe as produced by higher quality scientists who can at least tally numbers correctly.

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Ivermectin for Prevention and Treatment of COVID-19 Infection

Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using ivermectin. Using ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.

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HYDROXYCHLOROQUINE – Observational Study on 255 Mechanically Ventilated Covid Patients at the Beginning of the USA Pandemic

Most Covid studies have not considered days of therapy, cumulative dose, or weight-adjusted dosing. We found that when the cumulative doses of two drugs, HCQ and AZM, were above a certain level, patients had a survival rate 2.9 times the other patients. By using causal analysis and considering of weight-adjusted cumulative dose, we prove the combined therapy, >3 g HCQ and > 1g AZM greatly increases survival in Covid patients on IMV and that HCQ cumulative dose > 80 mg/kg works substantially better. These data do not yet apply to hospitalized patients not on IMV. Since those with higher doses of HCQ had higher doses of AZM, we cannot solely attribute the causal effect to HCQ/AZM combination therapy. However, it is likely AZM does contribute significantly to this increase in survival rate. Since higher dose HCQ/AZM therapy improves survival by nearly 200% in this population, the safety data are moot. However, given the data presented here, the studies reporting HCQ’s effect of QTc intervals need to be re-evaluated.

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An Interview with Dr Vladimir Zelenko, MD

We are very honored to present this interview of Dr Vladimir Zelenko, the father of outpatient treatment for COVID-19 in North America. Dr Zelenko shares his own experience with COVID-19 as a patient, as he is recovering from a severe form of the disease.
He also talks about his cancer and how he was able to go through this dramatic episode of his life. Then, he presents his perspectives about outpatient treatment as practiced today and the evolution of the pandemic, among other topics.

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How much proof do you want? Hundreds of studies conclude – treat Covid-19 early with hydroxychloroquine!

HCQ is effective for COVID-19. The probability that an ineffective treatment generated results as positive as the 235 studies to date is estimated to be 1 in 6 quadrillion (p = 0.00000000000000018).
Early treatment is most successful, with 100% of 29 studies reporting a positive effect (13 statistically significant in isolation) and an estimated reduction of 65% in the effect measured (death, hospitalization, etc.) using a random effects meta-analysis, RR 0.35 [0.25-0.50].
92% of Randomized Controlled Trials (RCTs) for early, PrEP, or PEP treatment report positive effects, the probability of this happening for an ineffective treatment is 0.0017.

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Hyperglycemia, hydroxychloroquine and the COVID‐19 pandemic

Hydroxychloroquine also can act as an oral hypoglycemic agent, as patients with diabetes taking hydroxychloroquine for rheumatologic diseases had a significant reduction in hemoglobin A1c when compared to methotrexate,40 and thus can serve to reduce hyperglycemia, a possible COVID‐19 risk factor for disease severity.

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Clinical outcomes of patients with mild COVID-19 following treatment with hydroxychloroquine in an outpatient setting

Our investigation of a large national cohort appears to support early administration (within the first 3 to 7 days of COVID-19 diagnosis) of HCQ in mild COVID-19 disease in an outpatient setting for reducing hospitalizations and deaths without any serious adverse HCQ-related effects.
If this finding is confirmed in future clinical trials, HCQ as a cheap and available drug may still play a role in a specific population with respect to reducing COVID-19 burden, particularly in resource-poor countries.

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The Chloroquine Wars Part VI – The Simple Logic of the Hydroxychloroquine Hypothesis

The Hydroxychloroquine Hypothesis: That there is some appropriate dosage of hydroxychloroquine, alone or in some combination with other medication, that successfully prevents some COVID-19 cases (PrEP/PEP) or treats some COVID-19 sufferers (Early/Late/Critical).
Remaining entirely unblemished after a year of trials and observations, the current evidence in favor of the Primary HCQ Hypothesis fully validates the HCQ Hypothesis. The logic is so simple that it almost feels like your livelihood would have to be on the line to deny it.

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Censorship Kills: The Shunning of a COVID Therapeutic

The science shows that ivermectin works. Over 40 randomized trials and observational studies from around the world attest to its efficacy against the novel coronavirus. Meta-analyses by four separate research groups, including ours, found an average reduction in mortality of between 68%-75%. And 10 of 13 randomized controlled trials found statistically significant reductions in time to viral clearance, an effect not associated with any other COVID-19 therapeutic. Furthermore, ivermectin has an unparalleled safety record and low cost, which should negate any fears or resistance to immediate adoption.

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The Chloroquine Wars Part IV

Why then does the pharmaceutical industry and its promoters insist on conducting RCTs before something is accepted as true? RCTs take substantial amounts of time and significant resources to conduct. This creates a barrier to entry, especially for inexpensive solutions to medical problems. In other words, the myth that RCTs are some necessary “gold standard” is a deception that, along with regulatory agency, prevent any possibility for simpler and less expensive (less profitable) medical solutions to gain traction.

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The Chloroquine Wars Part III

If the argument rests on “RCTs as the gold standard”, there is little doubt that the evidence dramatically favors using HCQ as a standard early stage therapeutic! But it is reasonable to assess the quality of all the evidence to reach beyond gold for the ultimate and supreme standards of scientific evidence. That too we plan to present in future articles.

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Professor Risch Responds to Dr Rushworth over Hydroxychloroquine Post

“As a clinician, you should know that Covid-19 outpatient disease is viral replication, vs hospitalized disease which is florid pneumonia. These are absolutely different conditions and studies of the treatment of one cannot be extrapolated to the treatment of the other.
This massive body of evidence, summarized by the Cochrane Library, demonstrates that well-conducted hydroxychloroquine observational studies on average, produce very similar associations as the corresponding RCTs.

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