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Yale professor: Feds making 'unconscionable mistake' blocking hydroxychloroquine for COVID patients

Harvey Risch says treatment effective in helping people in early stages of disease, especially those with higher risks.

Published: August 12, 2020 10:24pm

Updated: August 13, 2020 8:10am

Amid the ongoing coronavirus pandemic Yale School of Public Health epidemiology professor Harvey Risch is asserting that the drug hydroxychloroquine, in conjunction with zinc and appropriate antibiotics, can help high-risk patients recover from COVID-19.

Risch draws a distinction between two stages of the illness, noting that while the treatment will likely work quickly during the first stage, it is not effective in helping people who have advanced to the more serious second stage.

"At the first stage, it is a flu-like illness. That illness will not kill you. If you are a high-risk patient and begin treatment immediately, you will almost certainly be done with it in a few days. When not treated, high-risk patients may progress. The virus then causes severe pneumonia and attacks many organs, including the heart. In this second stage, hydroxychloroquine is not effective," he explains in a Washington Examiner opinion piece. 

Risch says that people in the high-risk category should be provided treatment even before they receive the results of their coronavirus test.

"The second thing to know is that most low-risk patients survive without treatment. Low risk means you are under age 60 and have no chronic conditions such as diabetes, obesity, and hypertension, have no past treatment for cancer, are not immunocompromised, etc. High risk means you are over 60 or you have one or more of those chronic conditions. High-risk patients need immediate treatment when they first show symptoms," he said.

"It is a serious and unconscionable mistake that the FDA has used inpatient data to block emergency use petitions for outpatient use. Further, already back in March, the FDA approved the emergency use of hydroxychloroquine for hospitalized patients, for whom it is demonstrably less effective than for outpatients," he said. "If hydroxychloroquine satisfied the FDA criteria for emergency inpatient use in March, it should more than satisfy those criteria now for outpatient use, where the evidence is much stronger."

Risch said that if the drug were widely accepted as useful in treating the virus nobody would stand to rake in significant profits as a consequence, which he suggested could be contributing to the current climate surrounding the drug.

"I can only speculate about the cause of the FDA’s recalcitrance. Hydroxychloroquine is an inexpensive, generic medication. Unlike certain profit-generating, patented medications, which have been promiscuously touted on the slimmest of evidence, hydroxychloroquine has no natural financial constituency. No one will get rich from it," he said.

"Further, it seems quite possible that the FDA, a third of whose funding comes from drug companies, is under intense pressure from those companies to be extremely conservative in its handling of hydroxychloroquine. If hydroxychloroquine is used widely and comes to be recognized as highly effective, the markets for expensive and patented COVID-19 medications, including intravenous drugs that can only be used in the hospital, will shrink substantially," Risch wrote.

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