Yale epidemiologist says evidence shows HCQ safe for Covid 'standard of care'
“These medications need to be widely available and promoted immediately for physicians to prescribe. ... If these combined medications become standard-of-care, they are likely to save an enormous number of lives that would otherwise be lost to this endemic disease.””
By TATIANA PROPHET
A professor of epidemiology at the Yale University School of Medicine has reviewed all 16 studies of anti-malaria drug hydroxychloroquine, and not only does he state that it will save thousands of lives threatened by Covid-19, but recommends it be used — with screening — as soon as possible to treat the disease.
In a passionate, at times pithy manuscript, Dr. Harvey A. Risch showed how the studies showing no benefit of hydroxychloroquine were looking at the wrong stage of the disease and evaluating an unnecessarily high dosage. He called one study “a fishing expedition” and another “deeply flawed.”
Dr. Risch, a cancer researcher as well as epidemiologist, concluded that “all available evidence” points to the general safety of the drug in combination with an antibiotic and “preferably zinc,” thus recommending it to become the standard of care.
When all other physicians have been silenced, including Dr. Oz, either being censored or walking back their enthusiasm for hydroxychloroquine, why is Dr. Risch one of the few voices still offering a full-throated recommendation of this drug, touted in March by President Trump as a game changer? Evidence. The studies that have been highly publicized, including the VA Hospital study and the Lancet, involved hospitalized patients, he said.
The manuscript, “Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis,” was accepted by the American Journal of Epidemiology and released Wednesday night.
Yale School of Medicine epidemiologist Dr. Harvey A. Risch.
“If these combined medications become standard-of-care, they are likely to save an enormous number of lives that would otherwise be lost to this endemic disease,” he wrote.
Dr. Risch went on to estimate that by the time any of the five scheduled outpatient clinical trials are completed by September, another 180,000 deaths would occur assuming “a flat epidemiological curve.”
“In this context, we cannot afford the luxury of perfect knowledge and must evaluate, now and on an ongoing basis, the evidence for benefit and risk of these medications,” he added. “Available evidence of efficacy of HCQ+AZ has been repeatedly described in the media as “anecdotal,” but most certainly is not.
“Evidence for single agents cannot be extrapolated to apply to combined agents, evidence for one biochemical form of a drug cannot be extrapolated to another form, and even more importantly, evidence for utility or lack thereof or toxicity in hospitalized patients cannot be extrapolated to apply to outpatient use, outpatient use comprising the sole argument for application that I am making in this review.
In the PDF of the paper, Risch went into great detail about all of the non-randomized, non-controlled studies that initially made headlines, namely the very first trial by Dr. Didier Raoult in Marseilles.
“This study has been criticized on various grounds that are not germane to the science, but the most salient criticism is the lack of randomization into the control and treatment groups,'“ he wrote. “This is a valid general scientific criticism, but does not represent epidemiologic experience in this instance. If the study had shown a 2-fold or perhaps 3-fold benefit, that magnitude of result could be postulated to have occurred because of subject-group differences from lack of randomization.”
He continued: “The study has also been described as “small,” but that criticism only applies to studies not finding statistical significance. Once a result has exceeded plausible chance finding, greater statistical significance does not contribute to evidence for causation. No different conclusion would have resulted had a study with 1000 patients found the same 50-fold benefit but with a P-value of 10-10. Study size limitation only applies to studies having findings within the play of chance. That is not the case here.”
Dr. Risch goes on to explore the studies that informed a recent pullback by the FDA, NIH and WHO, cautioning doctors on use of the drug, or prohibiting it altogether. In a study at Oxford University, looking into arrhythmia and prolonged QT interval, Dr. Risch said the patients were rheumatoid arthritis patients and the dosage they were taking was higher than that recommended for Covid-19. Further, of the hundreds of thousands of patients’ records reviewed in that study who took HCQ and AZ, 0.333% were shown to have suffered arrhythmia events.
“This discussion thus shows that the FDA, NIH and cardiology society warnings about cardiac arrhythmia adverse events, while appropriate for theoretical and physiological considerations about use of these medications, are not borne out in mortality in real-world usage of them. Treatment-failure mortality will be much higher, but even that pales in comparison to the lives saved. It would therefore be incumbent upon all three organizations to reevaluate their positions as soon as possible.”
The abstract concludes: “Hydroxychloroquine+azithromycin has been used as standard-of-care in more than 300,000 older adults with multicomorbidities, with estimated proportion diagnosed with cardiac arrhythmias attributable to the medications 47/100,000 users, of which estimated mortality is <20%, 9/100,000 users, compared to the 10,000 Americans now dying each week. These medications need to be widely available and promoted immediately for physicians to prescribe.”
Dr. Risch’s major research projects have included studies of ovarian cancer, pancreas cancer, lung cancer, bladder cancer, esophageal and stomach cancer, and of cancers related to usage of oral contraceptives and noncontraceptive estrogens.
