The FDA has authorized an early COVID treatment protocol

After nearly a year-and-a-half and over 618,000 recorded COVID-related deaths in the U.S. alone, the FDA has finally released an emergency use authorization for REGEN-COV, a new drug that was being tested in 2020 (pre-Biden). Primary care physicians can now use it as an early treatment option. Before now, the only authorized COVID-19 early treatment my family doctor had, per the July 2021 update to NIH guidelines, was to recommend quarantine and then wait until symptoms go away or report to a hospital if they get worse. Of note, these updated guidelines continue to identify hydroxychloroquine (HCQ) as a prohibited drug – although this should not be a surprise considering the war on HCQ began soon after President Trump dared to recommend it.

REGEN-COV, however, is no simple take-home medicine like the familiar Tamiflu frequently prescribed in the past 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 delaying even a few days would make Tamiflu less effective. Like Tamiflu, 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 it works on COVID. Coincidentally with its approving a new drug, the CDC is finally pulling the plug on the PCR test for COVID-19. The PCR test often gave false positives and can misidentify the seasonal flu as COVID-19 (although it will remain in use through the end of 2021).

According to the FDA fact sheet on REGEN-COV, the intravenous infusion process it requires appears time-consuming (it can take 20 to 50 minutes or more, with a one-hour monitoring period immediately after). For now, the FDA recommends it for use only on confirmed COVID-19 patients over the age of 12 who are at high risk of developing severe symptoms. However, the fact sheet permits some flexibility in using it 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 it chose to ignore India’s great success with its initial early treatment protocol that initially included HCQ. However, when the Delta variant arrived in India, it appeared more resistant to HCQ, so India immediately approved and widely distributed a new more potent outpatient COVID kit consisting of Ivermectin, Doxycycline, 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 in 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.

To oversimplify the process, the virus triggers an overproduction of white blood cells that mistakenly attack the body instead of the virus. The resulting internal inflammation is the primary cause of severe symptoms and deaths -- usually pneumonia, but a secondary contributor is a blood clotting response affecting critical organs, including the lungs.

Never forget that this war against these inexpensive drugs was not limited to the US. It was also fought in most western countries, including the UK and Sweden. However, Sweden, known for its risky minimal mask and lockdowns mandates, has apparently achieved herd immunity. (Its average daily deaths since mid-July 2021 have remained below 0.1 and are continuing steady at 0.01 in mid-August.) Sweden achieved this herd immunity in time to avoid new deaths from the Delta variant.

By comparison, neither the US nor UK have avoided the Delta variant, despite their more rigid mask rules, lockdowns, and higher vaccination rates. In fact, the lockdowns may have delayed achieving 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 has 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 UK, and the US had discovered something like REGEN-COV when the pandemic started or had the courage to permit using 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 by saying that there are many other factors that would have ruled out this overly optimistic result. 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 the lack of domestic manufacturing and supply chain resources to produce and distribute the needed drugs.

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

Image: REGEN-COV. YouTube screen grab.

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