Where Are the Therapies?

Where Are the Therapies?

*While news broke yesterday about a potentially imminent vaccine developed by Pfizer, as no date is set for the release of the vaccine, we thought it was still relevant to publish the following regarding Covid-19 therapeutics. *

On Friday, October 1, the country learned that President Trump had contracted Covid-19.  Yet in just 8 days, he was able to resume his public appearances and his aggressive campaign schedule.  The obvious question:  how did he do it?  How was he able to conquer the virus in a week and resume his campaign rallies?  The answer is therapeutics.  Trump was treated with Regeneron – a monoclonal antibody, steroids, and a 5-day course of Remdesivir.  Can patients who are not the president receive these treatments?  Well until November 9, the answer was no.  Until October 21, 2020, the answer was no.  On October 22, 2020 the Food and Drug Administration (FDA) granted emergency use authorization (EUA) to remdesivir but only under very limited circumstances.  Finally, on November 9, the FDA granted an EUA for Eli Lilly’s monoclonal antibody.  Lilly’s therapy is the first treatment available to patients with mild or moderate cases of Covid-19 who are not hospitalized.  This is very good news but why has it taken so long.  Where was the sense of emergency in a pandemic?  Indeed, the FDA, the Centers for Disease Control (CDC) and the National Institute of Health (NIH) websites still contend that there is no treatment for Covid-19 – at least until you are very sick and need hospitalization.  

Here are the Therapeutic Guidelines from the NIH.  

Notice, the NIH recommendations for the American medical Standard of Care for anyone not hospitalized is go home, take two aspirin, and call the doctor if you get worse.  What kind of care of this?  What kind of system would deny therapeutics until patients are very sick?  What kind of system would delay treatment thus reducing the chances for recovery?  What kind of system?  A very bad system.

What do we know?  We know from anecdotal data that early treatment can be effective.  We know that a number of common anti-viral agents and at least one anti-parasitical agent have seen beneficial results.  We know that steroids and a cocktail of drugs, if given early enough, can substantially reduce the chances for a cytokine storm and severe infection.  The American Journal of Medicine published a paper in August discussing potential early treatments in outpatient settings, i.e., at home.  We know that the FDA has over 550 potential drug therapies under study.  Where are the results?  We are in a pandemic that is now 8+ months old.  We certainly have enough patients to establish whether known therapies don’t work – patients treated according to the American Standard of Care – and whether patients who have been provided therapies do work such as the much-maligned Hydroxychloroquine (HCQ).  

The government’s clininicaltrials.gov website enumerates the trials on potential drug therapies and their status.  There are 3876 studies related to Covid-19 listed on the page.  Out of the 3876 studies, 14 – let me say that again – 14 are recorded as completed with published results.  In searching for specific treatment options, here are some examples as of Novermber 10, 2020:

  • HCQ – 260 studies; 4 completed with published results
  • Ivermectim – 41 studies; 5 completed with published results
  • Monoclonal antibodies – 58 studies; NONE completed and NO published results
  • Steroids – 57 studies; one completed with published results.

Trump has proved that waiting on the silver bullet vaccine is not our only option if you catch the disease early enough.  Thankfully, Americans now have at least one possible treatment option available today before they are hospitalized.  So, if you get sick, pressure your medical professionals for the treatment the President received.  And do it early. 

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