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NEJM: Compassionate-Use Protocol Study of Remdesivir in Severe COVID-19: Good Results in 53 patients, majority of them already on ventilators; 84% improved after 28 days.


Coronavirus by Engin Akyurt via (open access)

A new study published by the NEJM (New England Journal of Medicine) yesterday (Note: Virus research reports are free to all to read under rules agreed to by most media) revealed clinical data for 53 patients with severe COVID-19 due to SARS-COV-2 (the novel coronavirus, or just the virus).  Over a thousand patients have been treated under the “compassionate use protocol” (a plan which allowed Gilead to provide remdesivir to selected patients upon individual application).  Gilead sponsored and controlled this study, which makes sense given that they are the sole source for this still-investigational drug.

Originally, remdesivir was developed to treat Ebola virus, but it wasn’t successful there; most patients with Ebola died regardless of treatment, and the epidemic was stopped by careful contact tracing and isolation.  In addition, Ebola appears to be attenuated (weakened) by serial transmission (in moving from one patient to the next) so that by the fifth successive patient infected, the clinical disease manifestation (the patient’s outcome) was manageable and survivable.  Each jump of Ebola from animal (bats, probably) to man resulted in massive, fatal infection leaving a highly infectious corpse to be buried by traditional methods of washing and handling.  Those who attended the funerals of Ebola victims frequently became the next to die.  Now there are a few scattered cases of Ebola cropping up here and there, but there is no sustained outbreak.  Traditional burial practices have changed, which has helped.

Gilead has a good drug, and it is still under patent, so they have an incentive to test and promote remdesivir for the next disease.  This disease promises to be a real money maker for the pharmaceutical industry in general, or at least Gilead in particular.  Therefore, they sponsored, paid for, supplied drug for, collated data for, and wrote up the first draft of the study I am referencing.

The results of this study are encouraging.  It is not meant to be anything like conclusive, merely a demonstration that the drug is safe and appears to have a beneficial effect.  Furthermore, stronger studies are likely to be in the pipeline.  In keeping with the “compassionate use” idea, the patients selected for this study were mostly severely ill; over half were on ventilators and most had been sick for over ten days already.

According to the protocol, remdesivir was given intravenously once a day for ten days.  No other investigational drugs (including hydroxychloroquine) were given during remdesivir treatment.  Antibiotics and other supportive medication were given as desired by the individual doctors treating each patient.  68% of patients showed significant improvement after eighteen days, and 84% by twenty-eight days.  Seventeen of thirty patients on mechanical ventilation were extubated (had their endotracheal tubes removed) and three of four patients stopped ECMO (extra-corporeal membrane oxygenation, or passing the blood through a membrane filter which supplies oxygen to substitute for the lungs).  Eighteen percent of patients on ventilators died and thirteen percent died overall.  These figures compare favorably with the numbers in patients not treated with remdesivir, who were not directly included in the study (there was no matching of placebo or control patients due to the compassionate use protocol).

This study is far superior to the reported studies of hydroxychloroquine for several reasons.  First, it included many patients who were severely ill at the outset of treatment, with low oxygen saturation (oxygen blood levels), older, and generally sicker before they were infected.  Second, only patients with severe kidney failure and liver inflammation were excluded; mild renal insufficiency, diabetes, hypertension (high blood pressure), and other diseases were allowed.

Controlled studies comparing the outcomes in similar patients who were not given remdesivir will soon follow.  An advantage of the patent protection and profit motive afforded Gilead for this drug is that they are sure to collect data and publicize it as quickly as possible, to benefit from the demand for more of this drug.

Whether the profit motive ends up being beneficial for humanity in this case is still open to question.  Much depends on who will pay and how much.  If rich governments like the United States pay for widespread treatment, then Gilead’s profit will wind up being a rounding error in the overall federal stimulus plan, which exceeds $2 trillion already.

If private patients in the US are forced to pay for remdesivir treatment, then the results will be widening inequality, bankruptcies, and pressure on Medicaid (the federal program which pays for some indigent patients to receive medical care).  The pandemic has already resulted in widening income inequality as most workers in service-sector jobs are becoming unemployed.  Those who live paycheck-to-paycheck are suddenly coming up short in food, rent, and emergency expenses.  Inequalities in exposure to the virus (service-sector employees cannot work from home), infection, and outcomes (death or recovery) are already becoming starkly apparent.

These inequalities will lead to a further drive towards authoritarianism.  This is so because income and wealth inequality is a prime source of public unrest, and authoritarian leaders thrive on popular discontent.

It gives anti-democratic bosses an excuse for cracking down on dissent, blaming the usual suspects, and aggrandizing their powers.  Fortunately for the US, the man nominally in charge is as incompetent as he is narcissistic, as scatter-brained as he is sociopathic, and is as obvious a liar as he is nepotistic.

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