"Now, here we get to the heart of why we haven't expanded testing more rapidly. There are university researchers who said, 'We don't need swabs. We can actually just test saliva.' So, there's a group at Rutgers that showed you can just have people spit in the tube and you test the saliva.
Another group at Yale that said, 'Actually, the saliva samples are even better than using the nasal pharyngeal swabs.'
Russ Roberts: Fewer false-positives and false-negatives, presumably.
Paul Romer: Yeah. Now, slightly better, not hugely better. But way more convenient and there is no shortage of swabs.
So, why hasn't everybody started switching to the saliva tests?
Well, even under the expedited process of giving Emergency-Use Authorizations, EUA, at the FDA [Food and Drug Administration], the FDA said to the group at Rutgers, 'Okay. You can test saliva samples, but only with this particular it for collecting--this particular type of tube that people spit in. And only your lab. We're not approving anybody else to do what you just discovered how to do.'
And then, even worse, they said, 'And, only if the person spits into a tube under the supervision of a healthcare professional.' Then it's like, 'Okay, well, I mean, can we do telemedicine? Can they spit in the tube but you watch them?' 'No, it has to be in the physical presence of a healthcare professional to spit in the tube.'
Now, why they mandated that, I have no idea. After four weeks they finally said, 'Okay. They let you do the swabs at home without supervision. So, we'll let you spit in a tube now without supervision.'
But, it's still the case that the only lab that can process those samples is at Rutgers, and 'If anybody else wants to be a good citizen at some university campus and start doing this, you just have to come ask us and we'll take several weeks and we'll decide whether we're going to let you.'
And, we will never get to the level of testing we need if we operate under that kind of regime, under the FDA. So, that has got to change."
Another group at Yale that said, 'Actually, the saliva samples are even better than using the nasal pharyngeal swabs.'
Russ Roberts: Fewer false-positives and false-negatives, presumably.
Paul Romer: Yeah. Now, slightly better, not hugely better. But way more convenient and there is no shortage of swabs.
So, why hasn't everybody started switching to the saliva tests?
Well, even under the expedited process of giving Emergency-Use Authorizations, EUA, at the FDA [Food and Drug Administration], the FDA said to the group at Rutgers, 'Okay. You can test saliva samples, but only with this particular it for collecting--this particular type of tube that people spit in. And only your lab. We're not approving anybody else to do what you just discovered how to do.'
And then, even worse, they said, 'And, only if the person spits into a tube under the supervision of a healthcare professional.' Then it's like, 'Okay, well, I mean, can we do telemedicine? Can they spit in the tube but you watch them?' 'No, it has to be in the physical presence of a healthcare professional to spit in the tube.'
Now, why they mandated that, I have no idea. After four weeks they finally said, 'Okay. They let you do the swabs at home without supervision. So, we'll let you spit in a tube now without supervision.'
But, it's still the case that the only lab that can process those samples is at Rutgers, and 'If anybody else wants to be a good citizen at some university campus and start doing this, you just have to come ask us and we'll take several weeks and we'll decide whether we're going to let you.'
And, we will never get to the level of testing we need if we operate under that kind of regime, under the FDA. So, that has got to change."