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Doctor on FDA's plasma approval: ‘The data being used for this is not the best’

Emergency Medicine Physician in Houston, Texas Dr. Richina Bicette joins Yahoo Finance’s Akiko Fujita to discuss the latest coronavirus developments as the FDA allows emergency use authorization for convalescent plasma treatment.

Video Transcript

AKIKO FUJITA: Well, let's get back to that news on the coronavirus treatment. Now the FDA authorizing the emergency use of convalescent plasma for the treatment in some of these serious cases. I want to bring in Dr. Richina Bicette. She is a board-certified emergency medicine physician in Houston, Texas.

And Dr. Bicette, I want to start with that news there that we got over the weekend. Certainly a lot of skeptics who say-- who question the efficacy of this. We should point out, this falls short of a full approval. So we're still talking about the emergency use.

But how do you view this treatment? And how significant is this approval for emergency use?

RICHINA BICETTE: Akiko, it makes sense. The medicine makes sense. Convalescent plasma is not a novel idea. If you look back in the 1800s, plasma was actually used to treat diseases like the flu and chickenpox. Back in the 1700s, an African slave described the process of using inoculation to help with the smallpox outbreak in Boston in the 1700s. So it's not a novel idea.

What is difficult to understand, though, is how the FDA applied the rudimentary data that it had in order to allow it to go ahead and approve plasma for emergency use. And actually, within the last couple of weeks, the FDA actually released a statement saying that they were not going to approve plasma as a proven treatment for COVID. This past week, we've seen the president send out a number of scathing tweets towards the commissioner of the FDA, accusing them of not approving its use for possible political gain. And then suddenly, we get the announcement that convalescent plasma is being approved for emergency use.

The data that is being used for this is not the best. It's retrospective analysis. And it has not been peer reviewed. So although it may be promising and it deserves some further investigation, we do not have concrete data showing us that convalescent plasma is proven to benefit patients who are being treated for COVID-19.

AKIKO FUJITA: So what's the risk in moving forward with this kind of treatment, given, to your point, the data isn't in place?

RICHINA BICETTE: Well, what we would like to see is a randomized, controlled trial. That is the gold standard in terms of clinical science and when you're trying to figure out if a treatment is going to be proven effective. And with this emergency use authorization coming out and with the president touting it to be a miracle cure, which so many are hopeful for, it's going to be difficult for us to proceed with randomized, controlled trials.

Imagine, if you were a patient enrolling in a study and you knew that there was a 50% chance that you could get this miracle drug that's being-- that that's being touted as being so effective, or you could get a placebo, would you sign up for a randomized, controlled trial like that? Probably not. So it's going to be difficult for us to now pursue that gold standard, which will really give us the evidence on whether this is truly a beneficial treatment.

AKIKO FUJITA: And Dr. Bicette, you pointed to concerns about the political pressure the FDA is facing right now. To that point, we got that article from the "Financial Times" over the weekend, saying that there was potential-- that there was-- that the administration is exploring potentially pressuring the FDA to fast track the development of AstraZeneca and Oxford's vaccine candidate. And I heard you say something interesting on that front, which is to say that there is so much money being poured into vaccine development right now from the federal government at a time when that money can be used to more effectively treat and manage the virus immediately. Can you elaborate on that?

RICHINA BICETTE: Absolutely, Akiko. We've seen that there are billions of dollars right now that are being allocated and that are being funneled towards vaccine development. And that's great, because we do need a vaccine. But where are the funds that are being allocated towards stopping the virus right now? That's what we're not seeing.

What we've noticed is that the federal government has kind of taken a step back. And they'd like to play a supporting role. And they'd like for local governments to enforce mandates and to put policies in place to stop the spread of COVID-19. But here we are in August, almost September, 176,000 deaths later, and it's shown that that is not working. We need the federal government to step up and to allocate some of those funds to fighting the virus right now.

There are still hospital systems that are rationing their PPE and are making their staff reuse personal protective equipment that was designed for single use. There are businesses that are feeling forced to open because if they don't open, they'll declare bankruptcy. We can divert some of those funds to small business owners.

Divert some funds to creating more reagents so that we have more testing capabilities. Because the more we're able to test, the better we are able to stop the spread of the virus. So if there are that many billions of dollars that we can allocate to vaccine development, I would hope that the federal government would be able to allocate some funds to stopping the spread of the virus right now.

AKIKO FUJITA: And Dr. Bicette, when you look at numbers of infections nationwide, we have started to see that number level off. I'm curious what you're seeing on the ground there in Houston. Have you seen an improvement? And if so, what specifically on?

RICHINA BICETTE: We are slowly starting to see improvement in numbers of hospitalizations and number of ICU cases. That's really how we can determine the effect of COVID-19 on our hospital systems. So the numbers are getting better.

However, I say that with a bit of caution, because what we've seen so far in the way that this pandemic has been handled is we put a measure in place. We notice that it's effective. And then we go back to our normal lives. And things kind of get out of control again.

What we have to do in order to make sure that we maintain stop of community spread of this disease-- put measures in place. And once you see that those measures are working, continue to have those measures in place. It's been proven that wearing masks work. Social distancing works. Let's continue to do those things until we stop community spread.

AKIKO FUJITA: Finally, even as you start to see an improvement on the ground there, you've got two major storms that are headed your way-- Hurricane Marco, Tropical Storm Laura. How does this complicate the coronavirus response when you're dealing with a natural disaster that potentially could be headed your way?

RICHINA BICETTE: Akiko, it's like one thing after another. Just when we're starting to see a little bit of improvement in the COVID-19 pandemic, now we have what many are stating will be the busiest hurricane season in recent history right on our heels. It's very important that we are very cautious and try to maintain our vigilance and be as prepared as possible this hurricane season, because natural disasters can only compound the effect of the pandemics that we're seeing.

Hospital systems are trying their best to do even more to get prepared, not only for hurricane season, but for the upcoming flu season that we have. We're still encouraging our patients to maintain social distancing, even if you have to shelter in place because there's a storm coming. If you have the option to be in a home that has multiple rooms, each family should have their own room that they're quarantining in and still try to kind of maintain social distancing with people that you have not being in a house with.

Patients need to make sure that they have at least two weeks worth of their prescription medications on hand in case you can't get to the pharmacy or in case you can't get a hold of your doctor during a natural disaster. If you have chronic medical conditions, like cancer, requiring chemotherapy infusions, or end-stage renal disease, requiring weekly or ever-so-often dialysis, make sure you speak to your doctors and you speak through your infusion centers so that you know what the backup plan is going to be in case you can't access those resources during a disaster.

AKIKO FUJITA: Certainly juggling a lot on the ground there. But we wish you the best. Dr. Richina Bicette joining us from Houston, Texas.