1/25 @Gladwell did a brilliant interview podcast with @michaelmina_lab. One of the questions @Gladwell asked is why don’t we have the #dailyrapidtest already to fight #covid? The answer is the FDA. Here is a lightly edited transcript of that part of the podcast.
2/ The rapid tests for #covid look like a pregnancy test, and they work like a pregnancy test actually. It's a little piece of paper, generally speaking.
3/ And you put some of the sample, whether that is a swab that's been mixed with some saline solution, or saliva onto a paper strip, and... and it shows up with line. It turns either, for example, red if it's positive or blue if it's negative.
4/ And... and those can be made in... in huge numbers. They don't require instruments. Tests like these are used for malaria, for strep, for all these different infections. They've been around for a very long time.
5/ You can produce the #covid tests for a fraction of $1, and they might be sold to the public or built by the government for, you know, $1 apiece or something along those lines.
Why aren’t they already approved?
Why aren’t they already approved?
6/ The only pathway that we have to evaluate tests like this in the United States are medical diagnostic pathways.
7/ They are pathway is designed specifically to ensure that a physician, like a detective, is getting all of the information they need to diagnose a sick person in front of them.
So, it's really been, first and foremost, a regulatory hurdle.
So, it's really been, first and foremost, a regulatory hurdle.
8/ We actually don't have a regulatory pathway to approve a test whose primary objective is... is one of stopping the #covid epidemic, versus one of diagnosing a sick person. And that's held everything up.
9/ All of the companies that could be producing these... these really rapid #covid contagiousness tests in the millions and millions.
10/ The companies have been sitting on these tests trying to hone them, trying to get I'm just a little bit better, just a little bit better so that they can pass through FDA standards as a medical diagnostic test.
11/ It's not just slowing down their approval and getting them out to the public for #covid contagiousness tests. It's actually bottlenecking the companies into creating #covid tests that are not going to be as scalable, because they're having to use more expensive reagents.
12/ They're starting to put them with instruments and package them more. You know, they have to actually become more expensive, highly-manufactured #covid tests.
13/ When they're just these little pieces of paper that, if we can do the cheap version of them, they could be made very fast, but they just won't get through the FDA at the moment.
Well, you know, it's not that they're not smart, it's that this is a regulatory body.
Well, you know, it's not that they're not smart, it's that this is a regulatory body.
14/ They just don't have a pathway. You can't go and apply for FDA approval for a public health test tool. In fact, they say it strongly in their FAQs and their facts that say, “We do not evaluate public health tools.”
15/ So, why bother getting FDA approval?” Unfortunately, these tests are defined by the FDA as clinical diagnostic tests, which has a pretty broad definition of a test that gives somebody information about themselves that could cause them to change their behavior is a…
16/ …clinical diagnostic test. So this catch 22 where they're saying, “You know, we don't want to have anything to do with approving public health tools. But we also don't want to allow you to say that that's not a clinical diagnostic test.”
17/ And so, they've got... they've gotten stuck in this regulatory bureaucratic nightmare of just regulation for regulation’s sake.
There is precedent at the FDA, for example, to think about public health tools. Vaccines are one of them.
There is precedent at the FDA, for example, to think about public health tools. Vaccines are one of them.
18/ They are willing... they've outright been willing to say, “We will accept a vaccine that has 50% efficacy.”
19/ And that's because, whether they recognize it or not, it is they're taking into account the public good part of a vaccine, that they understand that it will lead to herd immunity.
20/ So... but they have none of that thinking in diagnostic tests, because it's just driven by this very antiquated view of... of what a diagnostic test means.
And in our country, everything has been... you know, the medical establishment is extremely strong.
And in our country, everything has been... you know, the medical establishment is extremely strong.
21/ You can't go to get a cholesterol test without getting a prescription from your doctor. Like, why why can't we know that? You know, it's all through this very, very heavy medical lens.
22/ And changing that... moving... getting that that big ship to turn is it's not just turning out to be a very, very difficult task, but it's actually, I think, inadvertently leading to 1000s of additional deaths that we don't need to be having.
23/ I encourage you to listen to the whole podcast. It's pretty short and very well edited from a much longer interview.
Addendum: at the end of the podcast, @michaelmina_lab said he has been talking to the FDA and they do seem to be listening. But still, they do need to act, and soon.
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