When President Trump emerged from Walter Reed Medical Center, he seemed pretty convinced that the treatment he was given was a cure for COVID-19. He reported feeling better almost immediately after being given Regeneron, a polyclonal antibody formula. Yesterday, Regeneron published the results of the first three phases of their trials for treating COVID-19.
Regeneron has completed the required randomized, double-blind studies that Dr. Fauci insisted on. At the end of September, the company reported that the treatment reduced viral levels in a study of 275 patients who had no evidence of an immune response before receiving the therapy:
“After months of incredibly hard work by our talented team, we are extremely gratified to see that Regeneron’s antibody cocktail REGN-COV2 rapidly reduced viral load and associated symptoms in infected COVID-19 patients,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occurring immune response.
Now the company is confirming that the treatment significantly reduced medical visits in a trial of another larger group of patients:
“The first job of an antiviral therapeutic drug is to lower the viral load, and our initial data in 275 patients strongly suggested that the REGN-COV2 antibody cocktail could lower viral load and thereby potentially improve clinical outcomes. Today’s analysis, involving more than 500 additional patients, prospectively confirms that REGN-COV2 can indeed significantly reduce viral load and further shows that these viral reductions are associated with a significant decrease in the need for further medical attention,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron.
Once again, patients with the highest viral load and no native immune response demonstrated the most benefit. The antibody cocktail reduced COVID-19-related medical visits by 72% in patients with one or more risk factors. The preexisting conditions included being over 50 years of age, obesity, cardiovascular, metabolic, lung, liver, kidney disease, and immunocompromised status.
The study also showed there was no difference in outcomes between the high-dose and low-dose treatment. The low dose also had no infusion reactions. This is good news because there is a limited supply of the drug as the company moves to obtain an Emergency Use Authorization (EUA) from the FDA. This would allow current production to treat more patients as the company ramps up production.
According to NBC News, Eli Lilly and Co. has a similar therapy and applied for a EUA. Between Regeneron and Eli Lilly, the government has contracted for 600,000 doses of the treatment. President Trump has said he would push for a EUA after his experience with the therapy and wants it to be free for Americans who need it.
Any significant delays in the authorization must be viewed skeptically at this point. The FDA still has a warning regarding the use of HCQ for COVID-19 outside a hospital setting on its website. This causes politicians and professional boards to interfere with its use to treat COVID-19 in the outpatient setting in some states.
This dishonest attack on HCQ, even though millions of patients worldwide have taken this medication safely for decades, is an indictment of the agency. According to Yale epidemiologist Dr. Harvey Risch:
There is extensive evidence that HCQ, when used within the first five days of symptom onset, produces a sharp and statistically significant reduction in hospitalization and mortality. Seven controlled, well-conducted clinical studies show this: 636 outpatients in São Paulo, Brazil; 199 clinic patients in Marseille, France; 717 patients across a large HMO network in Brazil; 226 nursing-home patients in Marseille; 1,247 outpatients in New Jersey; 100 long-term care institution patients in Andorra (between France and Spain); and 7,892 patients across Saudi Arabia.
All of these studies pertain to the early treatment of high-risk outpatients, and all showed 50% or higher reductions in hospitalization or death. Not a single fatal cardiac arrhythmia attributable to the HCQ was reported among these thousands of patients. In addition, a new summary analysis of five randomized controlled trials has also shown a statistically significant outpatient benefit, proving the case.
The barriers to effective outpatient therapy are becoming unconscionable, and everyone should be concerned that the FDA will drag its feet on Regeneron as well. Our agencies should be making every effort to reduce hospitalizations and the progression to severe illness.
While Regeneron’s good news has been announced, the Mendacious Midget™ Dr. Anthony Fauci is on CNBC fear-mongering and calling for a national mask mandate:
Dr. Fauci: “This is going to get worse. Because we’re going more into a colder season …We’ve got to do something different. We can’t just let this happen. We’re going to have many more hospitalizations and that will inevitably lead to more deaths. So, this is an untenable situation.”
Shepard Smith: “Is it time for the [national mask] mandate, Dr. Fauci? We lean on you for advice. Do we need a national mandate, or not?”
Fauci: “You know, yes. Well, we do. If we don’t get one, I would hope the mayors and governors do it locally.”
We can do something different tomorrow, Dr. Fauci. Stop the war on HCQ and allow doctors to prescribe it early and in outpatient settings according to their medical judgment. The FDA provided no substantial data to support cautioning against outpatient treatment when several senators formally requested it.
Then, issue the EUA for Regeneron and Eli Lilly for those who need that option. Let’s keep patients out of the hospital, stop covering our faces and cowering, and get on with life. It seems to be within our current reach to be able to this. It almost seems as if the Mendacious Midget™ has a vested interest in ensuring we don’t until you are forced to take a vaccine. Almost.
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