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LIFE IN THE TIME OF COVID

Studies Seek Vaccine,

But Treatments Too

Sternberg
Richard Sternberg, a retired Bassett Hospital orthopedic surgeon, has agreed to provide his professional perspective while the coronavirus threat continues. Dr. Sternberg, who is also a village trustee, resides in Cooperstown.

There has been a great deal of information both published and awaiting publication in the scientific literature about COVID-19. There’s so much literature it’s sometimes difficult to separate the wheat from the chaff, determining how accurate information may be no matter how well-meaning the researchers.

In the treatment of COVID-19. There are no fully FDA-approved medications or treatment protocols. So far, the FDA has released EUAs (emergency use authorizations) for certain medications or use of products.

An EUA is not formal approval in the legal sense of the word but rather, in times of declared states of emergency, allows use of an unapproved product or an approved product in an unapproved manner.

This is still based on scientific evidence and requires a review process, but it is not as stringent
and time consuming as a full FDA approval, which usually takes years.

Obviously, in the situation we are in now, we don’t have years.

An article published last week online by the Journal of the American Medical Association reviewed multiple studies on the effectiveness of using corticosteroids to treat COVID-19.

This showed that, in a statistical review of the pooled results of seven studies, systemic (intravenous) use of corticosteroids decreases the mortality rate of patients with severe COVID-19 by 20 percent.

The interim review of these studies so strongly showed a benefit of the use of steroids that further studies were halted since ethics required now treating all patients with severe COVID-19 with steroids.

Last week, the FDA extended its EUA for remdesivir, an antiviral drug. Previously, this drug had been allowed only for severe cases of COVID-19 with respiratory distress, but on Friday a statement was issued stating that, on the basis of all the literature available, the FDA felt it was reasonable to believe that Veklury (remdesivir) may be effective in the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients and that the potential benefits outweigh the known and potential risks of its use.

The report did go on to say that more study was necessary to determine and confirm these results and to determine which patients stood to benefit most and at what dosage and over how long a course. The study was performed by the NIH.

In the early days of the pandemic, when there was spiking of cases in the U.S. and especially the Northeast, physicians used ventilators based on what they knew from other disease processes.

Based on what has been tried and learned from treating COVID-19, protocols have been
changed dramatically. Even determining which patients will benefit from a ventilator has been reconsidered.

Finally, one thing that I found particularly exciting was the use of Artificial Intelligence in helping to find treatments. AI is being used to predict what drug combinations in specific combinations and doses might be effective.

AI can cross-reference all known information about how a drug works and dosage schedules with those of other drugs and recommend treatment applications.

For example, while remdesivir has been proven to be statistically effective and, so far, is the most effective anti-viral treatment known, it still is not anywhere near universally effective.

An HIV medication, lopinavir/ritonavir, which had been tested and found lacking against COVID-19 when used by itself, has been suggested as making remdesivir more effective when combined. Based on the prediction, a study is in progress.

Scientists are not just waiting for an effective vaccine to try to prevent COVID-19 infection but continue to actively work on treatments for people who already have the disease. As time goes by, more information will be found and will be better vetted so that treatment options improve.

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