Thursday, April 30, 2020

A cure for COVID-19?

We are all desperate for a “cure” for the coronavirus illness, COVID-19. Since even the most optimistic accept that a vaccine is at least a year away (and that would be unprecedently fast), a drug that could offer a cure is the next great hope. On Wednesday, the press reported a statement by Dr. Anthony Fauci about the drug remdesivir from Gilead Science. The headlines touted “a cure,” a “game-changer,” and Gilead’s share price soared.

Do we really have an “effective treatment” against coronavirus? No, not really. Here is what Dr. Fauci said in a much-hyped White House announcement: “The data shows that remdesivir has a clear-cut significant positive effect in diminishing the time to recovery . . . The mortality rate trended towards being better in the sense of less deaths in the remdesivir group – 8 percent versus 11 percent in the placebo group. It has not reached statistical significance, but the data needs to be further analyzed.” When a result is described as not having reached statistical significance, this means that the differences could be due to chance alone. Flipping a coin three times, you will not be shocked to get heads three times, and it does not mean the coin is rigged. Similarly, small differences in response to different treatments will often show up without meaning there is a real difference, but simply by chance.

As to the “positive effect” cited by Dr. Fauci, he was describing a reduction in the mean duration of hospitalization from 15 days to 11 days. That is good, but hardly “an effective treatment against coronavirus” or a “drug that can block the virus” as the headlines blared.

Dr. Fauci’s announcement was unusual because it was made before the results of the trial have been published or subjected to peer review. To his credit, Dr. Fauci described the results as “preliminary.” He also tried to tamp down expectations arising from his announcement by saying that the data was a “proof of concept” rather than an effective treatment, similar to early results of drugs against AIDS. That important qualification was missing from many headlines. We later heard from Dr. Fauci that he made the announcement because he “feared it would come out in leaks.” While perhaps understandable, hardly the best reason or way to present science.

Contrast the NIH-sponsored trial with the results of a trial done in China and published on-line on April 29 in The Lancet, a prestigious medical journal. These researchers randomly assigned 237 patients with severe COVID-19 (all with low oxygen levels and pneumonia seen on CT) to remdesivir or placebo, They found that remdesivir use was not associated with a difference in time to clinical improvement, though there was trend to faster improvement with the drug in patients who were started on treatment earlier. They also found that treated patients had more “serious” adverse effects. There was no difference in death rates between the two groups (and those who read these posts regularly know I focus on that - a number that is neither subjective nor able to be fudged).

Why the difference between these two studies? Probably because the effects were so small that it was similar to a coin flip, but perhaps because one or the other trial had flaws. Since the Chinese study was peer-reviewed, it has inherently more credibility. Whichever proves to be more correct, the drug may (or may not) be helpful but is hardly “a cure.”

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3 comments:

  1. We are ever hopeful and not accustomed to a lack of "miracle drugs" for our ills. That is why so many tout "non-scientific" data. Thanks for once again, giving us the truth.

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  3. Thanks for the clear explanation of why remdesivir has not yet been shown by either study to be an "effective treatment." Too bad you are not invited my MSNBC and CNN to give your explanation on one of their news analysis programs.

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