Remdesivir II

This is, in fact, another post on Coronavirus, but it will take me a while to get to the point. To put the conclusion here, I think that it is important to get the FDA out of the way (by executive order if necessary).

The Food and Drug Act, as currently interpreted, requires the assumption that people should (generally) not be treated with pharmaceuticals which haven’t been proven to be safe and effective. The rule is first do no harm, second do no harm. This only makes sense if results with current standard of care are acceptable. In this case, they aren’t. I think there should be mass production and use of Remdesivir starting on the 5th of March, based on one case where it seems to have cured a patient overnight.

To be honest, I think it should have been approved based on evidence that it is safe (from failed efforts to treat Ebola) and evidence that it inhibits the RNA dependent RNA polymerase of the MERS Coronavirus

Obviously one case is not proof. Still more obviously a pre-clinical study of a related organism isn’t strong evidence about the novel coronavirus.

So ?

It isn’t as if the current approach is working so well, that we should stick with it until there is proof that a new approach works better.

I think the trace of information is enough that, given almost no knowledge and a very diffuse posterior, one can conclude that the expected welfare of a patient treated with Remdesivir is higher than of one not treated with Remdesivir.

At this point, the standard ethical rule that decisions should be made in the patients’ intererests would mandate use of Remdesivir
(I personally do not accept that rule)

Instead, the approach will be “slow and sure wins the race” and “better safe than sorry” and almost all patients will have to wait while a clinical trial is conducted to find if it is proven beyond reasonable doubt that they are better off with Remdesivir.

Prescribing a new pharmaceutical is, legally, like locking someone up, except the procedure is actually followed by the FDA. That is we are really protected from unproven pharmaceuticals, while many people currently presumed innocent are in jails.

This makes sense under two conditions. First that the status quo is acceptable, so that one shouldn’t run risks attempting to improve it. Second that the status quo is a stationary steady state (or approximately a steady state) so it is an available option.

The second condition is not met in this case. We can’t choose that things remain as they are. The current dynamic is one of exponential increase of Coronavirus infection.

Rather the small c conservative option is business as usual, that is we keep doing what we have been doing. I think resorting to English rather than plain Latin is a sign that new evidence has forced rethinking

(I delete a tangent on the old simple classification “Homo sapiens” and the relatively new highly technical term “modern human” introduced because the old terms “Homo sapiens” , “Homo neandrathalis”, “Homo sapiens sapiens” and “Homo sapiens neandrathalis” all asserted falsifiable hypotheses by definition and off to the ontological proof of the existence of God)

Consider an anology — Global warming. A clearly invalid argument is that we don’t know enough to decide what to do, so now we should collect more data so we can decide. This argument is made by (interested) opponents of green policy. The implicit assumption is that waiting to act until we have more information is not an irreversible decision. But of course it is. That is why the very alarming estimates of the consequences of following this crazy advice are called the “business as usual” scenario. It isn’t sticking with the status quo, because the world is changing as we debate getting warmer.

Similarly, we can’t stick with the Covid 19 status quo. We can stick to business as usual such that new treatments are allowed only when they are proven beyond reasonable doubt to be effective. Or we can consider costs and benefits in a halfway sane manner and try things as soon as we know they are safe.

Remdesivir is known to be safe, because it was used (unsuccessfully) to treat Ebola. There is good reason to hope it is effective. There is no good reason to deny sick people treatment with Remdesivir. Now.

I am glad to say that I am not the only person worried about the FDA get
ting in the way

update. Thanks @pgl for this link

To me the text does not correspond to the title. I note

Given the lack of available virus-attacking treatments for COVID-19, some gastrointestinal discomfort isn’t such a big deal, but elevated liver enzymes could nail remdesivir’s coffin shut.

Too early to judge
While all three experienced gastrointestinal issues, one was complaining of diarrhea before receiving remdesivir. Nothing tanks an experimental new drug faster than elevated liver enzymes, but concentrations among some patients that weren’t treated with remdesivir peaked higher than those that were.

Here I think the logic is that *given* the FDA rule of first do no harm second do no harm and third do no harm, this might delay or prevent approval of Remdesivir. It doesn’t seem close to me to suggesting that it *should* prevent use of remdesivir. Elevated liver enzymes are not typically a sign of problems with a high risk of death. Covid 19 in the elderly is a problem with a high risk of death. In any case, there isn’t much evidence that Remdesivir use is correlated with elevated liver enzymes.