Why we’re still arguing about hydroxychloroquine

Contact Your Elected Officials

The battle over hydroxychloroquine began as a kind of trivial but apparently earnest and hopeful celebrity endorsement of the drug (the celebrity being President Trump). It has devolved into a real political and public-discourse horror show.

Perpetual back-and-forths between those prominent doctors who do not believe in the drug’s effectiveness — coronavirus task force members Anthony Fauci and Brett Giroir are two — and dissident, lesser-known doctors, such as Harvey Risch of Yale University, have given birth to serious questions about how truly scientific the whole conversation has been.

Can hydroxychloroquine be used effectively to treat COVID-19? The most prominent voices say no, citing several randomized controlled trials, but others say it is, citing their own clinical evidence.

The question that nobody seems to be asking is, what is the standard of evidence required for granting emergency use authorizations, or EUAs, for drugs in the first place? And what are the limits of various kinds of clinical trials?

The Food and Drug Administration approved an EUA for use of hydroxychloroquine and chloroquine in hospitalized patients on March 28. Importantly, for the purpose of reinforcing distinct categories, its authorization was for a targeted use: hospitalized patients. When the FDA authorized the drug, there was no significant evidence of effectiveness from randomized controlled trials, or RCTs.

In a March 28 letter on authorization, FDA Chief Scientist Denise Hinton wrote, “Based upon limited in-vitro and anecdotal clinical data in case series, chloroquine phosphate and hydroxychloroquine sulfate are currently recommended for treatment of hospitalized COVID-19 patients in several countries … FDA is issuing this EUA to facilitate the availability of chloroquine phosphate and hydroxychloroquine sulfate during the COVID-19 pandemic to treat patients for whom a clinical trial is not available, or participation is not feasible.”

The letter suggests that randomized controlled trials are not the “gold standard” for authorizing an EUA. If they were, the March 28 EUA would not have gone through. RCTs do not appear to be the gold standard in other circumstances of drug approval, either. On July 31, the FDA granted accelerated approval of a cancer medication absent any randomized controlled trial.

Moreover, once the treatments and the trials began, researchers in the most notable studies followed those who the EUA had authorized for treatment, namely hospitalized patients. The FDA has since revoked its authorization of hydroxychloroquine on the basis of those various trials, determining no real effectiveness and even suggesting it is considerably dangerous.

These contextual points, along with a score of clinical evidence, are among the reasons that Risch, a professor of epidemiology at Yale School of Public Health, has argued in favor of using hydroxychloroquine to treat high-risk outpatients early in their disease.

To the evidence, Risch argues that doctors have offered more than enough evidence of hydroxychloroquine’s effectiveness for outpatient use in high-risk patients. To the authorization, the FDA does not need randomized controlled trials to issue an emergency use authorization. It could do so for outpatient use of hydroxychloroquine, and Risch says the evidence is there.

“We’ve been saying that the people to look at are the ones you have to treat,” Risch said in an interview with the Washington Examiner. “We’re talking about outpatient, high-risk treatment, and that’s it.”

Risch has emerged as a loud voice in favor of using the drug specifically for that category of patients, so loud and contrarian, in fact, that 25 fellow faculty signed on to a stinging rebuke of his advocacy for a targeted use of the drug.

Risch cites the clinical findings of doctors such as Vladimir Zelenko, a New York physician who has demonstrated success in treating high-risk outpatients with hydroxychloroquine, zinc, and azithromycin. He cites other evidence showing success in high-risk outpatients in Brazil and France, including reduced risk of hospitalization. Risch discusses these studies in a recent Newsweek op-ed (See PDF Below) and in a paper he wrote for the American Journal of Epidemiology (See PDF Below).

These findings, he argues, demonstrate evidence even stronger than a “may be effective” standard, justifying an EUA for outpatient use. “The FDA can’t go up to a doctor and say, ‘You haven’t seen what you’ve seen,’” he said.

by Jeremy Beaman, Commentary Fellow

Read Original Article on Washington Examiner

The Key to Defeating COVID-19 Already Exists. We Need to Start Using It

The-Key-to-Defeating-COVID

Opinion: Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis

Early-Outpatient-Treatment-of-Symptomatic-High-Risk-Covid-19-Patients

COVID-19 Treatment – Global HCQ/CQ Studies https://c19study.com/

c19study01-27-2021

The Thinking Conservative
The Thinking Conservativehttps://www.thethinkingconservative.com/
The goal of THE THINKING CONSERVATIVE is to help us educate ourselves on conservative topics of importance to our freedom and our pursuit of happiness. We do this by sharing conservative opinions on all kinds of subjects, from all types of people, and all kinds of media, in a way that will challenge our perceptions and help us to make educated choices.

The Choices We Make

Death and disagreement are inevitable. Love and hate are choices. We will all die. Before we do, what choices will we make?

Elon Musk Speaks at Unite the Kingdom Rally

Tommy Robinson held rally, with Elon Musk appearing virtually, calling attention to leftist politicians who allow foreign immigrants to invade England.

Doxed Democrats Are Getting Fired Left and Left

Not a misprint because a title of “left and...

Hold Up, Feds, Without Federalism, There Is No USA

Federalism is essential to governing the U.S., yet the federal government is undermining it by bribing states to implement unnecessary federal programs.

A Widow Inspires The World

Erika Kirk moved the nation with her speech two days after her husband’s assassination, vowing to continue his mission and grow Turning Point USA.

Parents Sue Character.AI for Allegedly Leading Kids to Sexual Abuse, Suicidal Behavior

Parents allege in three lawsuits that Character.AI’s chatbots sexually abused their children and drove them toward suicidal thoughts and behavior.

Tyler Robinson Makes First Appearance in Court, Faces Capital Murder Charge in Charlie Kirk Assassination

Tyler Robinson remained motionless throughout his first court appearance on capital murder and other charges after the shooting death of Charlie Kirk.

Trump to Appeal Ruling Allowing Fed Governor Lisa Cook to Keep Her Job

The Trump admin will appeal a three-judge panel’s ruling that prevents the president from firing Federal Reserve Governor Lisa Cook.

Charlie Kirk’s Alleged Murderer Confessed Shortly After Shooting, Messages Show

The man accused of murdering conservative influencer Charlie Kirk confessed to the killing in text messages, authorities said on Sept. 16.

Rubio Says US Visa Revocations Underway After Charlie Kirk Death Celebrations

SoS Marco Rubio said foreign nationals who made celebratory comments over Charlie Kirk’s assassination will have their U.S. visas revoked.

Trump Supports Designating Antifa a Terrorist Organization

President Trump said he would support designating the antifa movement a terrorist organization in the wake of Charlie Kirk’s assassination last week.

US Conducts Strike on Another Drug Boat From Venezuela: Trump

Three people were killed in a U.S. strike on a Venezuelan drug boat, President Donald Trump announced on Sept. 15.

Trump Signs Memo Targeting Direct-to-Consumer Pharmaceutical Advertising

President Trump signed a memo to ensure drug ads give fair, balanced, and complete information to protect and inform American consumers.
spot_img

Related Articles

Popular Categories

MAGA Business Central