So it's still very, very early.
And we want to be really careful not to overstate the promise or the potential of any one treatment
for coronavirus.
But I did want to update you about chloroquine.
We have news that the FDA has approved on an emergency use basis the use of chloroquine
and hydroxy chloroquine from the strategic national stockpile to look at using it to
treat corona virus in some patients.
Now, I want to be really clear here, because there's so many people misunderstanding this
because Donald Trump has been overselling it.
There are many possible treatments being looked at.
OK, we've got chloroquine with and without a throw myson.
We've got Ramdas Vier.
We have a combination of two different HIV drugs with and without a zero myson.
We've got some antibody treatments, convalescent plasma or plasma, as Donald Trump referred
to it a few days ago, dozens of other possibilities, drugs in development.
There's there's dozens and dozens of things going on.
Trump has been overselling chloroquine with a zero myson for a couple of weeks now.
Dr. Anthony Foushee has been careful not to oversell it.
It is not a proven treatment.
The letter that we now have seen from the FDA, which does approve this for some emergency
use, is also very cautious to say that this is not a drug approved for treating Corona
virus.
The FDA goes on to say, based upon limited in vitro and anecdotal clinical data in case
series chloroquine and chloroquine hydroxy chloroquine sulfate are currently recommended
for treatment of hospitalized coronavirus patients in several countries.
And a number of national guidelines report incorporating recommendations regarding use
of it in the setting of Cauvin 19.
The FDA encourages the conduct and participation in randomized controlled clinical trials that
may produce evidence concerning the effectiveness in treating coronavirus.
The FDA is issuing an emergency use emergency use number what a stands for.
But the idea of allowing emergency use to facilitate the availability of chloroquine
during the pandemic to treat patients for whom a clinical trial is not available or
participation is not feasible.
So making clear that we're not approving the drug for chloroquine, we're approving the
drug for discretionary emergency use when the patient can't participate in a clinical
trial.
It goes on to say, having concluded that the criteria for issuance of this authorization
is met.
I am authorizing the emergency use as described in the scope of authorization for treatment
of coronavirus when clinical trials are not available or participation is not feasible.
So we are waiting on results from what are called randomized clinical randomized controlled
trials.
What we have so far as a number of small trials have shown is conflicting information.
We have some small sample sizes that say the chloroquine treatment has worked well.
We have other small samples that say, you know, the people who didn't get it did just
as well as the people who did.
And as Anthony Foushee has pointed out, you have to be comparing the new treatment to
some standard of care and you need to be randomizing it.
Just because we've found some small studies with a core correlation does not mean that
we have found a causal link and case in point.
When you see just as many studies that say the control group did just as well, you have
to question the value of this as a therapeutic treatment.
We need a large, properly done, randomized controlled trial.
Until we get that, we won't really know.
So the FDA, I believe, is doing the right thing here.
It seems that the side effects and the risks are reasonable, assuming that you're getting
an EKG of patients that you're going to give this treatment to.
Chloroquine can affect what's called the Kutty UTC interval to heart related thing.
The FDA says in limited situations it can be tried when you can't get access to a clinical
trial.
Doing the EKG is a very important thing.
It's a constant balance of risk.
Reward side effects and the impact of not trying it.
When things start to get very, very dire.
Meanwhile, there are also people who are taking chloroquine for the actual approved uses who
are now having trouble getting it because many countries are starting to stockpile chloroquine.
That's another issue which we'll talk about at another time.
But everything has a cost is the point.
Let's take a quick break.
Much more coming up right after this.