I am not an expert in this medicine but I can give a few perspectives on this medicine that you might find helpful.
In a crisis situation there is very little time to act with complete certainty. In other words when a novel disease arises very rapidly you will not have time to perform large-scale randomized controlled trials on a drug as is usually done with the FDA approval process. Therefore you are often going to have to rely on incomplete data, and sometimes anecdotal evidence.
This offends the “evidence based” crowd. Those who stick too closely to the dictum, of “absence of evidence…” The problem is that if you withhold a reasonably safe treatment that might work on an extraordinarily ill individual, you have done them a disservice. So how do you decide?
Nassim Taleb gives us guidance. Taleb recently criticized Dr. Ionnodis, a very respected medical researcher, precisely because Ionnidas recommended gathering lots of data over the next 3 weeks and then figuring out what treatments work best.
Unfortunately waiting weeks and in a time of such rapid flux is akin to homicide for the deathly ill. We must act regardless since the problem is exploding as we speak and will explode more if we just wait for data.
How do we decide when an experimental drug is “worth it?” Taleb recommends analyzing the risk/payoff profile. If the profile is asymmetric, that is if there is potentially huge upside (cure) if the drug works and relatively little down side (patient is already deathly ill and likely will not be harmed by iatrogenics in proportion to what harm the disease is already doing) then it is worth trying the experimental treatment
Ultimately do we need data? Yes.
But you must make a decision contextually and situationally on when and how to use an experimental drug.
Apparently the FDA was disallowing the use of hydrochloroquinolone but recently changed its mind on the matter and is allowing physicians to use the drug on and off–labeled basis for Corona virus indications.
I believe that this should be more widely publicized. Twitter has been talking about its use for weeks. If nothing else the people on Twitter tend to be ahead of the curve when talking about potential new ideas.
But the fact that FDA allowed its use surely needs to become widespread news.
I have a former colleague in NJ (a surgeon) who told me that he got COVID 19 and got quinolone treatment and within 48 hours totally turned around. It was a game changer for him. He told me this before the FDA allowance came out. So it seems like MD were using the drug regardless even before the FDA gave the go ahead.
Anecdotal? Yes. But in times of crisis sometimes that’s all you have.
Editor’s note: Since I wrote the first draft of this piece, more data has come out about Hydrochloroquine. The data shows promise. No RCTs yet. But some case control studies show promise especially when used early and in moderate doses.
See data here
By Matthew DiPaola