US needs 'simpler studies' to speed coronavirus response, Duke expert says
Dr. Mark McClellan, director of the Margolis Center for Health Policy at Duke University and a former FDA commissioner, says U.S. regulations on clinical trials need to be streamlined so treatments for coronavirus can move more quickly from the lab to the marketplace.
vaccine is the ultimate goal. Researchers continue to look for ways to treat patients. But a recent study in the UK found the addition of a steroid and treating severe cases can significantly reduce depths. So why not use it? Experts here say public health authorities don't support this type of research. Dr. Mark McClellan is the former FDA commissioner and current director of the Center on Health Policy. A Duke. He's one of the authors in the op ed recently posted in The Wall Street Journal, and he joins us Live to talk about these findings and hurdles to finding potential treatments. Dr. McClellan, Thank you for joining us tonight. We really appreciate your time and let's jump right into it. The headline of a steroid study is enough to turn heads right Julian it is. This is an old drug. It's been around a long time. A lot of people did not think it would work for very severely ill patients with a viral infection, because steroids often make infections worse. But what we learned from this randomized study where people are randomised to get the steroid versus the usual care, was that it did make a difference in mortality, and we need more studies like that to really bring down the severe side of this pandemic. If we could reduce the deaths and the hospitalizations, this would be a much more manageable infection in our population. Dr. McClellan is interesting if you that you use the word random. It seems to appear to be effective. So why don't health officials here back it? Well, health officials here also working very hard. Julian toe learn more about what treatments really work, and it's a question of how to go about doing these studies. The so called randomized clinical trials and the traditional way to do it in the United States, especially, is to be very careful about how they're designed, collect loss and lots of data very specific about who can enroll in how exactly they're treated. And that's fine under normal circumstances. But we're not under normal circumstances were having patients and hospitals that in many forces country are starting to get overwhelmed again. There's just not that the time and the resource is available to do these very, very detailed studies, so we need simpler studies, and Duke University actually has a history of doing studies like this back in the 19 eighties for heart attacks when lots of people died in the hospital. This turned out to be a quick way to get lots of more people enrolled in studies at many more hospitals and then learn more quickly about which treatments can make a difference for these very seriously ill patients. You're right. This is not normal times. This is one question has been floating around our newsroom. Should the Barbie lowered for expectations when researching and experimenting during a pandemic, I don't think it should be lowered. We need to make sure that treatments are safe and effective enough to be used. But Julian, when we're talking about people who are dying in the night In the United Kingdom, where the study was done, 40% of the people who are hospitalized with e serious complications from Cove in 19 were dying. So we need to do trials that air simpler. That give us a first answer on treatments that can make a difference in outcomes, And the way to do that is to simplify the trial, make it easier for more hospitals, more doctors and more patients to participate so we can learn faster. But, you know, as we stay in this pandemic, do you see a situation in which health officials would permit, possibly an exception? Well, I think the approach we have to that in the United States is something that we're doing with an antiviral drug now room death severe So it has not yet been fully approved by the FDA. But there have been enough studies done where there's a good degree of confidence that it does help. And so that's available under what's called emergency use authorization, which means that patients can get it. We can learn a bit more about it. While these clinical studies are continuing. I think that's the right kind of model, not lower, not aiming to lower the standards. We want to make sure for, especially seriously ill patients. These treatments actually work, but we do need to speed up making available under appropriate conditions. So there's a middle ground. Everything okay? As we wrap up, let's talk briefly about 30 seconds or so about what happened today in North Carolina. I know you saw it as well. Your reaction to the governor's announcement requiring face covers installing the reopening. It's I think appropriate to stall. The cases were going up in other parts of the country. We're seeing cases not only rising but rising exponentially doubling fast where hospitals are in danger of being overwhelmed. So we need to take those basic steps like you were talking about before keeping a distance were possible wearing a mask always when you're close to other people hand washing, staying home if you've got symptoms. And for now, going slow helps us make sure we can do that effectively without losing control of the virus as always. Thank you. Thank you. Thank you. Dr. Mark McClellan. Four year time. Once again. Dr. Mark McClellan, F former FDA commissioner and current director for the Center of Health Policy. And Duke, thank you for your time and insight. Good to be with you. Thank you.