A new COVID treatment?

Nearly a year and a half has passed, and over 618,000 COVID-19 related deaths were recorded in the U.S. alone, and finally the FDA released an emergency use authorization for REGEN-COV, a new drug that was undergoing testing in 2020 (pre-Biden).  It is now an early treatment option for primary care physicians.  Until this point, the only authorized COVID-19 treatment my family doctor had per the July 2021 update to NIH guidelines was recommend quarantine, wait until symptoms go away, or report to a hospital if they get worse.  It is noteworthy that these updated guidelines continue to name hydroxychloroquine (HCQ) as a prohibited drug, but it should be no surprise, considering that a war on HCQ began soon after President Trump dared to recommend it.

However, REGEN-COV is no simple take-home medicine like the familiar Tamiflu frequently prescribed for the seasonal flu.  For example (in the "old days" that ended in March 2020), my wife and I both caught the seasonal flu.  Our doctor immediately prescribed Tamiflu and azithromycin because he knew that a delay of even a few days would make Tamiflu less effective.  REGEN-COV is similarly recommended only for early use before severe symptoms can develop.  

Once the initial surge of COVID-19 cases and deaths started in March–April 2020, the seasonal flu magically vanished along with Tamiflu despite some early indications that it works on COVID. 

According to the FDA fact sheet on REGEN-COV, the intravenous infusion process it requires appears time-consuming (can take 20 to 50 minutes or more with a one-hour monitoring period immediately after).  For now, it is recommended for use only on confirmed COVID-19 patients over the age of 12 who are at high risk of developing severe symptoms, but it permits some flexibility to be given as a preventative to especially high-risk patients.  It sounds so promising that the FDA was careful to say it is not a substitute for the vaccines. 

The FDA has known from the beginning that early treatment of COVID-19 is essential yet chose to ignore India's great success with its initial early treatment protocol that initially included HCQ.  However, when the delta variant arrived, it appeared more resistant to HCQ, so India immediately approved and widely distributed a new more potent outpatient COVID kit consisting of ivermectin, doxcycline, and zinc.  This less-than-$3 kit quickly reversed the delta variant death trend there.  Finding the true cost per dose of REGEN-COV proved more elusive — ranging from $10 to $2,100 per dose.  Grab your "Good Rx" card just in case.   

REGEN-COV and all the medications used by India appear to work similarly by calming the characteristic overreaction of the body's auto-immune system (cytokine storm) that COVID-19 can trigger in some patients with compromised immune systems.  Advanced age is a major factor, notably from vitamin D deficiency.  If the cytokine storm can be controlled early, the immune system can work properly and produce the antibodies that kill the virus.     

Never forget that the war against these inexpensive drugs was not limited to the U.S.; rather, it was also in most Western countries like the U.K. and Sweden.  However, Sweden, known for its risky minimal mask and lockdowns mandates, has apparently achieved herd immunity (the Swedes' average daily deaths since mid-July 2021 have remained below 0.1 and are continuing steady at 0.01 in mid-August) in time to avoid new deaths from the delta variant.  In comparison, neither the U.S. nor the U.K. did despite their rigid mask mandates, lockdowns, and higher vaccination rates.  In fact, the lockdowns may have delayed the achievement of herd immunity in time to avoid the spread of the new delta variant.  India, with fewer than 10% vaccinated, is also nearing herd immunity and had far fewer per capita deaths than most for the entire pandemic.  You can monitor the death trends of these four countries here.  

Having spent most of my career as an analyst, I wondered what the outcome would have been if Sweden, the U.K., and the U.S. had discovered something like REGEN-COV at the outset of the pandemic or had the courage to permit the use of India's inexpensive early outpatient treatment protocols.  This question can be simplistically answered by using India's reported 331 cumulative deaths per million as the best possible expected outcome (assuming the results for REGEN-COV would have been similar) and multiplying that same number of deaths (311/million) by the populations of the three Western countries:

The potentially avoidable death counts in the last column (in red) are beyond alarming.  The results in the next to last column (in green) resemble the expected deaths in a normal seasonal flu year.  Obviously, the skeptics will reject this result, citing that there are many other factors that would have ruled out this optimism.  Examples include questioning the accuracy of India's data, the difference in average ages of each country's population (India has far more young people), and lack of domestic manufacturing and supply chain resources to produce and distribute the needed drugs.  

Nevertheless, the results do question the wisdom of the government-medical establishment's decision to delay authorizing any early treatment protocols to instead gamble on the vaccines' timely arrival or the hope that something new (and more profitable) like REGEN-COV would magically appear.  We cannot change history, but we should have the wisdom learn from it.

Image: Stansbury.

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