American Journal of Epidemiology publishes article urging immediate and widespread access to hydroxychloroquine and azithromycin for US physicians, May 27, 2020, by Dr. Harvey A. Risch

“Hydroxychloroquine+azithromycin has been widely misrepresented in both clinical reports and public media.“...”The workforce and effort required to carry out contact tracing on these tens of millions of Americans is not practical." Dr. Harvey A. Risch, American Journal of Epidemiology 

May 27, 2020, “Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis,” Harvey A. Risch, American Journal of Epidemiology

Harvey A. Risch: “Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, Connecticut 

Correspondence to Dr. Harvey A. Risch, Department of Chronic Disease Epidemiology, Yale School of Public Health, P.O. Box 208034, New Haven, CT 06520-8034 (e-mail: harvey.risch@yale.edu; phone: (203) 785-2848)

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Harvey A Risch

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“American Journal of Epidemiology, kwaa093, https://doi.org/10.1093/aje/kwaa093 

“Abstract 

More than 1.6 million Americans have been infected with SARS-CoV-2 and >10 times that number carry antibodies to it. High-risk patients presenting with progressing symptomatic disease have only hospitalization treatment with its high mortality. An outpatient treatment that prevents hospitalization is desperately needed. Two candidate medications have been widely discussed: remdesivir, and hydroxychloroquine+azithromycin. Remdesivir has shown mild effectiveness in hospitalized inpatients, but no trials have been registered in outpatients.   

Hydroxychloroquine+azithromycin has been widely misrepresented in both clinical reports and public media, and outpatient trials results are not expected until September. Early outpatient illness is very different than later hospitalized florid disease and the treatments differ. 

Evidence about use of hydroxychloroquine alone, or of hydroxychloroquine+azithromycin in inpatients, is irrelevant concerning efficacy of the pair in early high-risk outpatient disease. Five studies, including two controlled clinical trials, have demonstrated significant major outpatient treatment efficacy. 

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="" span="" 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. 

Azithromycin, Covid-19, Doxycycline, Hydroxychloroquine, Remdesivir, SARS-CoV-2, Zinc 

Topic:

• cardiac arrhythmia
• doxycycline
• azithromycin
• hydroxychloroquine
• ambulatory care services
• inpatients
• outpatients
• terminally ill
• antibodies
• mortality
• zinc
• older adult
• pandemics
• standard of care
• remdesivir
• sars-cov-2
• covid-19

Issue Section:

Special article 

© The Author(s) 2020. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

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Supplementary data

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AJE-Editorial_Web_Material_Technical_Revised_kwaa093 – docx file”

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PDF 

(page 4) “Introduction” 

“Aside from the now more than 1.6 million Americans found through testing and public health reporting to be infected with SARS-CoV-2, seropositivity studies in California (1, 2), Colorado (3) and New York City and State (4) suggest that some 10-50-fold larger numbers of people carry antibodies to the virus.

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The workforce and effort required to carry out contact tracing on these tens of millions of Americans is not practical. While these studies have generated some media criticism, recent similar studies of blood donor samples in the Netherlands found 3% with SARS-CoV-2 antibodies (5), and 5% among household volunteers in Spain (6). Even allowing for some degree of false-positivity of these antibody tests, they still indicate that appreciably larger fractions of the population have been infected than have been characterized by identified reported cases.

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“Flattening the curve,” by social distancing, mask wearing and staying at home, serves to reduce hospital loads and spread them out over time, but to-date has pushed infection reproduction numbers Rt down only to about 1.0 (7), thus even if maintained, over time very large numbers of people in the US may eventually get the infection. The great majority of infected people are at low risk for progression or will manifest the infection asymptomatically.

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For the rest, outpatient treatment is required that prevents disease progression and hospitalization. Exposures will occur as isolation policies are lifted and people begin to mix, even with various degrees of public isolation such as mask usage and physical separation still in place.

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Thus, the key to returning society toward normal functioning and to preventing huge loss of life, especially among older individuals, people with comorbidities, African Americans and Hispanics and Latinos, is a safe, effective and proactive outpatient treatment that prevents hospitalization in the first place. 

(page 5)

All treatments have costs and benefits. In an ideal world, randomized double-blinded controlled clinical trials establish evidence for the relative degree of benefit, and if large enough, for estimates of the frequencies of adverse events. These trials take time to conduct: to get formal approval, to get funding, to enroll enough eligible patients, to wait for the outcomes to occur, and to analyze the data. In the context of the Covid-19 pandemic, we are presently averaging about 10,000 deaths per week in the US, under moderately strong isolation policies that have put more than 36 million people out of work. Results of currently ongoing or planned randomized trials for use of a number of outpatient medications are many weeks or months off, and there are no guarantees that the results for these agents, even if statistically significant, will show sufficient magnitudes of effectiveness to be useful clinically. 

We are rapidly reaching a breaking point in the ability to maintain the status quo; states have begun the process of lifting their restrictions, and we thus need to evaluate what evidence we do have for promising outpatient treatments. 

Review of Evidence…

(page 20) 

Until we have quantitative evidence for the utility and safety of other medications for preventing hospitalization and mortality in high-risk Covid-19 outpatients, the urgency of current mass mortality requires an immediate application of the best that we have available, even if knowledge is imperfect and even if yet unproven to the standards of double blinded RCTs. This problem will get even worse as states and cities yield to the acute pressure at this moment to begin lifting stay-at-home restrictions and even more people become infected. Some people will have contraindications and will need other agents for treatment or to remain in isolation. But for the great majority, I conclude that HCQ+AZ and HCQ+doxycycline, preferably with zinc (47) can be this outpatient treatment, at least until we find or add something better, whether that could be remdesivir or something else. 

It is our obligation not to stand by, just “carefully watching,” as the old and infirm and inner city of us are killed by this disease and our economy is destroyed by it and we have nothing to offer except high-mortality hospital treatment. We have a solution, imperfect, to attempt to deal with the disease. We have to let physicians employing good clinical judgement use it and informed patients choose it. 

There is a small chance that it may not work. But the urgency demands that we at least start to take that risk and evaluate what happens, and if our situation does not improve we can stop it, but we will know that we did everything that we could instead of sitting by and letting hundreds of thousands die because we did not have the courage to act according to our rational calculations.” (end, references follow)
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Among comments on topic of campaign against HCQ+zinc at Zero Hedge:

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5/29/20, “Hulk

 

Dude !!! It ain’t about the vaccines. They couldn’t have justified the destruction of the US economy and the middle class if there was an effective preventative, which there was ….” 

 

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My comment: Finally, one human being in authority, Dr. Harvey Risch, decides to stop participating in his own genocide. Thank-you, Dr. Risch. You’re the first person to speak up for those of us who have no voice to protest our long, slow, genocide.

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