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Helen W. Boucher, MD: Why We Need a Transparent Distribution Process for Remdesivir

MAY 26, 2020 | ALEXANDRA WARD

Segment Description: Helen W. Boucher, MD, FACP, FIDSA, chief of the Division of Geographic Medicine and Infectious Diseases at Tufts Medical Center, discusses the need for a transparent distribution process for remdesivir, plus COVID disparities, secondary infections, and what “the new normal” of health care looks like.

Interview transcript (modified slightly for readability):

Contagion®: Hi I’m Allie Ward, editorial director of Contagion®, and joining me today is Dr. Helen Boucher, chief of the Division of Geographic Medicine and Infectious Diseases at Tufts Medical Center in Boston, Massachusetts.

Dr. Boucher, thank you so much for joining us today. How are you doing? What has your day-to-day been like for the last couple months?

Helen W. Boucher, MD, FACP, FIDSA: Hi, Allie, thanks for having me. It's really nice to be with you. Our days have been pretty crazy. It's hard to believe, as we approach the end of May, that it has been 10 weeks since we started this epidemic. For all of us, our lives have been really upended, not only at work but at home with our families having to adhere to the stay-at-home orders and kids out of school and all those things. Here at the hospital, our life has been very different with a really 100% focus on COVID and working with the broader incident command team to make sure that we're as prepared as possible and able to take care of the patients who need us. We were very busy here at Tufts and we had a big surge back in mid- to late April, and we're coming down from that slowly. We still have a lot of COVID patients in the hospital who need our care and we're working hard to care for them and to address the needs of the patients who put off their regular medical problems during this epidemic.

Contagion®: You recently co-authored a viewpoint in JAMA about the need for a transparent distribution process after the emergency use authorization of remdesivir. Why is this so necessary?

Boucher: The drug remdesivir was authorized for emergency use by the [US Food and Drug Administration] under this mechanism called emergency use authorization. With that. the company, Gilead, donated a supply of drug to the federal government with the idea that the federal government would distribute it out to us so we could treat patients who need it. What we observed here in Massachusetts was that initially, only 4 hospitals received the drug, and that included 1 of our affiliate hospitals. And we in the ID community recognized that these didn't seem to be the hospitals with the most COVID patients. We all got together, pooled the resources, and donated them back to the Department of Public Health, which then allocated them across the state in a way that addressed the needs of most COVID patients so we could treat the most patients who could benefit from this medication.

This made it clear to us that something wasn't clear about this process. We didn't really understand how the federal government had allocated it so we here locally and we with the Infectious Diseases Society of America (IDSA) made a call for transparency surrounding the allocation of this drug. That sort of led to the piece that you mentioned that was authored by Michael Ison [MD, MS], Cameron Wolfe [MBBS, MPH], and myself in JAMA a few weeks ago.

I would say that things are better now. This model of the state Department of Public Health allocating the drug is being taken up by all the states now. It seems to be working pretty effectively. There still are some questions, though, about how decisions are being made at the federal level. We still have a long ways to go to get to full transparency.

Contagion®: Speaking of remdesivir, and given the current availability of data (and, sometimes, lack thereof), what are your thoughts on it as a potential therapeutic option for COVID?

Boucher: You raise a very good point, Allie. We still really lack access to the data that led to that emergency use authorization. Part of our initial call at IDSA was for access to that data so that we as treating physicians can make the best decisions about who would benefit the most from this drug. What we know is that there was an [National Institutes of Health] study that compared the drug to placebo, and that the people who received the drug remdesivir recovered more quickly than those who received placebo.

What we don't know is much more than that; it was a press release. That's really all we have access to. So we don't know which group of patients might have fared better. We sort of believe that earlier treatment is likely to be better with this drug based on some other studies, but we'd like to see the data and be able to digest them so that we can really understand the best way to use this precious resource. That's really what it is. This is the only drug for which there is any kind of authorization—it's not even approval—and evidence that it might be effective. I think it's very important that we as infectious disease clinicians use it in the most judicious and in a way that benefits the most patients as possible.

[Editorial Note: Shortly after this interview was recorded, preliminary trial data on remdesivir were published in the New England Journal of Medicine].

Contagion®: You recently recorded an IDSA podcast with Dr. Neil Clancy on secondary infections as they relate to COVID. What were the top takeaways from that conversation?

Boucher: This is an issue that really requires more study. We know that in influenza in another big pandemic, the 1918 Spanish flu, which we believe this COVID epidemic is mirroring in some ways, a lot of the deaths were actually caused by secondary bacterial infections. This is a concern in patients with COVID, especially those who lived through the initial illness and wind up on a ventilator, for example, and have these long, complicated courses. We've certainly seen, in our experience, patients who get bacterial infections, we've seen patients who arrived to us with concomitant bacterial infection with their COVID, and we've seen a group of patients who develop bacterial infections later. A concern is how best to diagnose them, how best to treat them, and then what percentage or proportion of those infections are caused by resistant bacteria. We need to study this in much greater detail.

The evidence that we have now is that anywhere from 10% to 80% of people have these infections. That's pretty wide, right? That leaves us with a lot of room for understanding. I think there're some unique challenges with COVID, and part of it is [that] diagnostic rigor is not as high as non-COVID patients because of the risk and the need for [personal protective equipment] with every procedure, for example, so even some study of how much diagnosis is being done, are we aggressively enough looking for bacteria in these patients? What should we be doing? Neil and I had a great conversation and talked about a number of these issues, really with a look towards the future in the hope that good studies will be done to really inform us. Of course, the final message is one of my main messages, [which] is that antibiotic resistance is with us. It's been with us, and it will be with us after COVID. So we can't forget about that and the need to focus on good antibiotic stewardship, diagnosis, and the availability of a pipeline of antibiotics are vitally important.

Contagion®: I saw an interesting point on Twitter recently about the disparities of COVID when it comes to surveillance and contact tracing. Why is it so important to address these disparities?

Boucher: It's a huge issue. We know that there are health care disparities in every disease, for heart disease and other diseases [it has] been shown that there are racial and socioeconomic disparities in access to care, treatment, [and] diagnosis, for example. In COVID, we've seen disparities in how the disease is popping up. Little epidemics have arisen in many different areas that include racial disparities, socioeconomic disparities, areas where people live closer together. That might include more first responders, people who have to ride public transportation—very, very important that we identify those and that we reach out with testing and treatment to both help those individuals, and then to help the greater public to prevent the spread of this infection, so a lot of work to be done. There's been some work done here in Massachusetts, the group at Mass General has done some work in some of the neighborhoods that had some of these little micro-epidemics, so we're learning from that. But I think some of the messages that can't be emphasized enough are the need to provide the availability of testing and treatment in ways that are socially and culturally acceptable to the groups. There is fear around COVID. Some people are afraid to come to the hospital. We're doing a lot of work to help dispel those fears, and I think we need to do more. We need to do more outreach to get to the places where people are and where they'll accept things like testing and treatment.

Contagion®: You bring up a great point about patients being fearful of seeking health care. We hear the phrase “the new normal” quite often in this current environment. How do you think COVID has changed or will change the way our health care system works, and will that change be permanent?

Boucher: COVID has changed our health care system already, right? We've had things like telehealth pop up in very big ways. I never did telehealth before, but now we're doing that almost exclusively for our outpatients. And I think many of us believe that's going to stay and a lot of patients really like telehealth. That's not to say it's perfect. It doesn't replace seeing a patient in person and doing a physical exam and those types of things. But it's a good tool to have in our toolbox. I think that's an example of something that's changed for the better.

I think the fear that you mentioned is one of the things that's changed for the worse. And we're working very hard to convince our community that we have all the safety measures in place in our hospital and our clinics that make it safe for people to come back and get the care they need. We're really concerned about people who put off their cancer care, their heart disease care, their diabetes care for too long during this epidemic and [we] want everybody to know that the safety measures we have work and that we can keep you safe and that we're here for you so that you'll come and get the care you need.

Contagion®: What is your advice to your infectious disease colleagues on the frontlines in terms of managing the emotional toll of pandemic response?

Boucher: That's a really important issue, and I think we're just getting to the beginning of appreciating that. I think for a lot of us, we've been in the throes of this on adrenaline for all these weeks. Unfortunately, I think that's why they call it post-traumatic stress. I think for a lot of people, as we come down, it will get harder. We're working hard in our institution to provide support to all the clinicians, to everybody who works here actually, to have the emotional and psychological support that's needed to get through this time. I think the things that all of us clinicians need to do are take breaks when we can, whether that's a 15-minute break to just breathe or do a quick meditation, or a day or 2 off, which I'm doing over this long holiday week. We need to take a break when we can, we need to support each other, we need to be more patient than we've ever been, because we don't know what everybody's dealing with not just at work, but at home. We all have families and some have children, some have older senior parents to take care of a lot of other stresses, childcare, you know, [it] goes on and on. And I think that just calls on the need for us to be extra kind to each other as we go through this, but I think we need to all be prepared that we do still have some hard days ahead even if the decline continues. This has been a trauma really, for all of us on the front lines who’ve gone through this and it's important to keep remembering that as we move ahead.

Contagion®: Thank you, Dr. Boucher. Is there anything else that you would like to add?

Boucher: Thank you so much, Allie, for having me and for your continued interest in all what we do in infectious disease.

Contagion®: Thank you so much for joining me and thank you for the work that you're doing.
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