Dr. Michael Joyner - Mayo Clinic Professor, joins the On the Move panel to discuss the latest in convalescent plasma treatment for COVID-19.
- And now we're going to turn to someone who deals in facts, very much so. He is the lead researcher on-- or one of the lead researchers on that convalescent plasma study that has been getting so much attention. As we talked about yesterday, the FDA issued an emergency use authorization for convalescent plasma to treat coronavirus.
We're joined now by Dr. Michael Joyner. He is a professor at the Mayo Clinic. He has many other titles, as well, and he was intimately involved with this study. We're also joined by our Anjalee Khemlani to speak to us about this. Dr. Joyner, you just have to unmute. I read that this study has now been discontinued as a result of this special authorization from the FDA. Can you confirm that for us, and tell us where you go from here?
MICHAEL JOYNER: Yes. We started as an expanded access program. The expanded access program is transitioning off. We'll enroll our last patients on Friday, and our last transfusions will occur on Monday, as the program transitions to an emergency use authorization. And it'll be easier for physicians and patients to get plasma, should they need it.
ANJALEE KHEMLANI: Doctor, it's Anjalee here. It looks like this is also a result of sort of a dilution of the participant pool because, with the EUA, you're not going to be able to really enroll. Does this also disrupt the potential for a randomized placebo controlled trial?
MICHAEL JOYNER: You know, the randomized placebo controlled trials, or the randomized trials had been struggling to enroll prior to this. And in sites that were not part of the expanded access program, and even in other countries where there is no expanded access program, accrual has been challenging. There are still a number of trials going on in the outpatient space and in the early disease state-- state that will not be affected by this. And of course, individual institutions will be at liberty to either offer or not offer plasma as part of the EUA, and conduct or not conduct randomized controlled trials.
- And doctor, this convalescent plasma was described by the president as a breakthrough. How would you characterize it, and how big of a tool is it going to be in fighting coronavirus?
MICHAEL JOYNER: I think what I would describe it as is a rediscovery. Products like convalescent plasma have been used since the 1890s to treat various forms of infectious disease. And if you had an infectious disease like a pneumonia, the flu, meningitis, prior to antibiotics in 1920s, 1930s, you frequently would have been treated with a product like convalescent plasma, where it was generally known to be safe. And just like our study showed, it was best to be treated early, within three days of infection, and it was important to get high-quality antibody product. So I see this more as a rediscovery of key principles that were known before the antibiotic era, and mostly have been forgotten, and again rediscovered through the expanded access program.
ANJALEE KHEMLANI: One of the key questions I think has been sort of the characterization of the results of the study. Commissioner Hahn, as well as Secretary Azar, have come under fire for what seems like, you know, explaining it incorrectly. Can you clarify what the results actually do show when it comes to the mortality rate and other statistics?
MICHAEL JOYNER: Correct. So I think one of the problems is people not specifying where they're talking about absolute risk or relative risk reduction. And what we typically see is that, if people in certain subgroups of the expanded access protocol are treated early, within three days of diagnosis, and given high-quality plasma, that their relative risk of death can be reduced somewhere between 20%, 25%, even 40%, 45%, depending on the group and so forth. But that-- you gotta remember, that means going from something like 15% to 9%, not 70% to 35%.
- And Dr. Joyner, just to be clear here, it sounds like, you know, throughout this whole thing, we have looked at the various companies that have-- that are working on vaccines or that have made various potential therapeutic therapies-- therapies for coronavirus. In this case, it's just the hospitals and the treatment centers that are doing this, right? In other words, it's not as though a pharmaceutical company makes this stuff. It's made by people.
MICHAEL JOYNER: People, and it's collected by blood bankers and processed in a way that can be administered to patients, just like regular what we call fresh frozen plasma when we do clinical medicine.
- Dr. Michael Joyner, thank you so much for your perspective on this. Obviously, as I said, you are intimately associated with this study, so it's helpful to get some clarity on all of this. Dr. Michael Joyner of the Mayo Clinic, thank you.
MICHAEL JOYNER: Thanks so much.