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April 2024

Paxlovid: Just Follow The Settled Science

“We will see…”

-Yours Truly

Precis: “Just follow the science.” “The science is settled,” etc. We have all heard these bromides only to be later instructed that we need to follow a different science truth, or that the science firmament has shifted. Frustrating isn’t it? You must think that scientists must be a wad of weasely, waffling, wags in white coats certain of only uncertainty. One day we sagely advise you that something is certain truth, the next day we say that new research says that something else is true because, well, we know and you just need to trust us. We know because we did those ephemeral, sacred rituals called studies that give us all-knowing wisdom that we then impart to you who should worship us. 

That, I hope you know, is the cynical view of science, which sometimes is deserved. But, there is another side of things, which should be heeded. That side is that everything technology-based; from medicine, sanitation, lights, electricity, cell phones, transportation, etc.; that we enjoy using and take for granted, was created by that same science. These two sides of science often collide and greatly confuse non-scientists, which is most people. That is a shame and that is why I blog—to try to reduce some of the confusion.

Paxlovid, a drug highly touted as the only oral medicine to treat COVID is a great example.

Backstory: Paxlovid was initially given emergency use authorization (EUA) for treating COVID by the FDA in 2021 because of promising preliminary observations. Clinical trials performed by its manufacturer, Pfizer, then quickly showed solid, eye-popping results that made the drug an overnight sensation. It demonstrated an 89% reduction in the risk of hospitalizations and deaths in infected individuals. It also shortened the disease and reduced the symptoms of those with mild to moderate COVID. All this lead to the NIH to prioritize it over other COVID treatments under investigation at the time. In other words, NIH put R&D on other potential anti-COVID drugs on the back burner because they had found an effective one.

Paxlovid was the first effective oral anti-viral treatment for COVID. It basically works by blocking a key enzyme the virus uses to make new virus particles. A second medicine in the drug is an old treatment for HIV/AIDS which affects liver metabolism of that key enzyme blocker allowing it to linger longer, thereby boosting its antiviral effect.

The only drawback to Paxlovid is that it needs to be started shortly after infection to be effective. It also interferes with several common medicines so some patients either have to forgo taking some of their regular medications for a while or avoid Paxlovid. Nevertheless, it has been quite beneficial for reducing COVID symptoms in infected people and preventing severe COVID disease.

What is new? Ok, now you can forget everything about Paxlovid you read above. A new clinical trial, also done by Pfizer, and just published in the New England Journal of Medicine, showed that Paxlovid does not help patients get symptom relief or reduce the incidence of severe COVID and hospitalization. In other words, Paxlovid had zero effect on COVID in the study just published.

Thus, the makers of the drug now have two studies with diametrically opposite results on the effects of Paxlovid on COVID patients. The first showed “eye popping” effects sufficient to get NIH to move all other drug investigations to a lower priority. The second showed that Paxlovid was no better than a placebo.

At this point, I suspect many readers are rolling their eyes and thinking this is just another example of “settled science” unsettling the “suckers” who listen to the weasely, waffling, wags in white coats. Well, unroll your eyes. Both results are right.

Say what? Yes, it is likely that both results are accurate because the two Paxlovid studies were done on quite different populations.

The first study, which showed a dramatic positivie effect of the drug was done pre-vaccination. The study population did not have the advantage of vaccine protection against COVID. The second study was conducted post-vaccines and the participants had the advantage of already being partially protected against severe COVID symptoms. That protection rendered the Paxlovid effect meaningless. It showed that the the drug doesn’t do much if you have been keeping up with your vaccines, and it shows the value of the vaccines.

Kudos to Pfizer for conducting and publishing the results of both studies, especially the second one. The results of the second study certainly will ding Pfizer’s bottom line, but it was an exercise in honest science. Still the results of the study do not leave Paxlovid totally off the COVID treatment radar. First, the study did not indicate that the drug is ineffective for high risk vaccinated patients, such as immunocompromised patients. And in the US, we still, unfortunately, have many un- and under-vaccinated people who would benefit from Paxlovid when they catch COVID. Finally, while this Pfizer trial involved about 650 test subjects, a much larger trial involving a few thousand subjects soon will be forthcoming from the UK.

So, if you are vaccinated and catch COVID, it is not crucial to get to your doctor in time to get on Paxlovid. And the UK trial might address additional questions that will tell us more about the value of Paxlovid in treating COVID. We won’t know until its study results are released. In other words:

We will see.

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