FDA's Surprise Frostbite Approval | The Numbers Are Shocking

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As I state in the video, I am not a physician. And I’m not suggesting everyone should take this drug. But I do work in healthcare analytics and I know how to read a clinical study. So, when this FDA announcement came out, I was originally interested because it was about frostbite, something I have to concern myself with. When i ready the study the FDA cited as the reason for the approval, I got more interested.

I guess it’s interesting enough from an analytic perspective, but what is more interesting to me is the notion of risk and the probability of active versus passive harm.

If you watch the video, and further if you read a summary of the study, you will notice lots of shortcomings in the study and the associated experimental design. We have a hard time isolating on the effect of the new drug. We have a hard time extrapolating the study population to the overall population via age, gender, and race. We have a hard time isolating on the outcomes given differing severities of frostbite. The sample size is incredibly small and lacks diversity. The treatment protocols varied. Other variables were not controlled.

But the FDA approved. Why?

You have to read between the lines, but I think it was likely two things. First, this drug has a long history of use, even if it was used for something other the frostbite. So, while that doesn’t say anything about the effectiveness of the drug as treatment for frostbite, it does tell a story about the potential risk profile of the drug and how well tolerated it is. Given the many decades of use, while not specifically mentioned in the study, the FDA would have a lot of information on an health problems the drug, itself, causes. Second, while we have a very small sample population, we have a large magnitude of improvement when compared to the previous standard of care. So, while we might not be able to isolate perfectly cleanly on the new drug’s impact, we can easily see that even a small improvement would be markedly better than whatever was the traditional protocol, which was resulting in many, many amputations.

So, in essence, we are very unlikely to do harm and there is reasonable probability that we will do some good if we try out the new drug. We won’t make things worse, but we might make things better. So, this isn’t about upside being guaranteed. It is about the upside of doing nothing not remotely approaching the upside of doing something.

There are lots of ways to manage risk, and certainty isn’t one of them.