Steven Libutti: Trusting science as COVID’s new wave looms over New Jersey

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Steven K. Libutti, MD, FACS

Director, Rutgers Cancer Institute of New Jersey
Senior vice president of oncology services, RWJBarnabas Health; Vice chancellor for cancer programs, Rutgers Biomedical and Health Sciences; Professor of surgery, Rutgers Robert Wood Johnson Medical School; Affiliated Distinguished Professor in Genetics, Rutgers School of Arts and Sciences.

My prediction is at the moment, just looking at the pace, and I have to admit some of this is hope, that the peak will be far lower than what we saw in March and April, stretched out over a longer period of time.

This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage is available here.

As he watches COVID-19 numbers climb in New Jersey, Steven K. Libutti reviews all the things he had learned last spring, when the pandemic first slammed the state.

There is a lot he knows in November that he didn’t know in March. But the greatest insight he has gleaned from the experience isn’t surprising in the least: “There was an urgency to try something to treat patients. And I respect that as a clinician, that you’re standing in front of an otherwise young person who is fairly healthy and suddenly is needing to be put on a respirator and may not make it,” Libutti, director, Rutgers Cancer Institute of New Jersey and senior vice president of oncology services, RWJBarnabas Health, said to The Cancer Letter.

“The scientific method is of critical importance. Because many of the treatments that were first believed to be effective turned out not to be effective, even though ‘common sense’ might have indicated they would be. But, when you apply the rigor of a well-designed clinical trial, you learned that they weren’t.”

Challenge No. 1 is not to allow the hospitals to be overwhelmed.

“The reason I think [mortality] was so high in New York and New Jersey back in the spring is we just became overwhelmed. There were just too many patients requiring hospitalization or intensive care. And that overwhelming of the system is certain to increase morbidity and mortality,” Libutti said.

“The way to keep from getting overwhelmed is somewhat straightforward. You’ve got to wear masks. You’ve got to try to limit the number of people in close spaces. You’ve got to wash your hands. And you’ve got to keep your distance. If we can do all those things on a national level, I think we can buy ourselves the time we need to get to vaccines being deployed more broadly.”

Last April, as the pandemic was about to peak in New Jersey, The Cancer Letter similarly checked in with Libutti (The Cancer Letter, April 6, 2020)

Cancer services at RWJBarnabas Health remained open through the spring spike, but volumes declined as patients were reluctant to come to the healthcare facilities. However, during the summer, the magnitude of services caught up, and the health system will likely have the same patient volumes or have a slight increase over last year, Libutti said.

Libutti said he is offended by the attacks on science that he has heard in recent months. “Our economy thrives with a healthy populace. And a healthy populace is based on our understanding of disease, which is rooted in science,” Libutti said. “And so, it gets a little concerning and a little frustrating when you see a pushback against science. Some think that if you silence science or you ignore it, bad things will go away. And, we obviously know that’s not the case.

“So, I hope folks like Tony Fauci and others that have seen a fair amount of at least verbal assault during this period don’t lose hope and lose faith. I think the majority of us understand the important progress we make when we pay attention to scientific findings.”

On Nov. 5, the United States reported over 120,000 new coronavirus cases, the highest number ever reported by a single country in a single day.

Libutti spoke with Paul Goldberg, editor and publisher of The Cancer Letter.

Paul Goldberg: How was your summer?

Steven Libutti: It was good as it could be expected, given everything we’re dealing with. Obviously, the case numbers in New York and New Jersey were down throughout the summer months. And so, that meant that we got busy with catching up with patients who had deferred less acute follow-up issues or less acute diagnoses, to handle that backlog of patients that was a challenge to get in in March, April and May.

And so, we were pretty busy over the summer, although in a good way, in the way you want to be busy, as opposed to what we were dealing with in March, April and May. It did give us a little bit of a break from the very acute footing that we were on in March, April and May that you and I talked about. And, from a personal note, it was nice to see my kids on occasion, because folks were downshifted a little bit from work over the summer.

But, we’re right back in it now. As you can see, from listening to the news or checking out the Hopkins website that tracks case numbers, we’re seeing an increase in cases in New York and New Jersey, not to the same extent as in other areas of the country, but the number of diagnosed cases and hospitalizations is increasing, albeit slowly. And so, we’re going back onto a more aggressive footing, to be ready.

I think when I spoke to you last, I had mentioned we had established a command center for cancer services across the health system. And, we were having weekly calls. At one point, it was twice-a-week calls. So, we just re-instituted our command center to have every other week calls right now. And, we’ll obviously increase the frequency of that if we see the numbers go up. But we want to begin to share information across the hospitals within our system, with respect to oncology services and where things are being strained, et cetera, as we begin to see increased cases.

I’m guessing that you’re looking at the COVID projections as often as you’ve been looking at FiveThirtyEight. What are your thoughts?

SL: When I look at what the numbers look like in New Jersey, and we’ve seen case positivity rates now go up between 4 and 5%, and R naught or Rt levels, that is number of patients potentially infected by a single patient go up to the 1.2, 1.3 range. And then, when you look at the daily case counts that come in from the Department of Health, we’ve seen day over day increases over the last month. It’s obvious, as we’re getting into the fall and winter, and people are going indoors more, we’re seeing an increase in cases. And hospitalization numbers across our system, although they’re nowhere near where they were at the peak, in April, they are increasing as well.

And so, what is hard to predict right now is going to be the ultimate amplitude of this wave, like how high are we going to get in daily cases, and then what the mortality curve is going to look like. My prediction is at the moment, just looking at the pace, and I have to admit some of this is hope, that the peak will be far lower than what we saw in March and April, stretched out over a longer period of time.

Our waves that we saw in the spring began in March, peaked in April, and was back down to a low baseline by June. So, March, April, May, June, over about a four-month period, we saw this bell-shaped curve, rising up rapidly, then coming back down to a new steady state. Never going away completely, but coming back down to a new steady state. Now, we’re seeing that rise begin to happen, but it doesn’t look as acute a rise or as high a slope of that rise as it did back in March and April. I think we were really overwhelmed with this big wave. And my bias is that that’s what drives the mortality.

We don’t have that many more tools than we did in April now for treating the disease. Although, I think we do have a much better understanding and appreciation of this virus and the disease it causes. I say that because there’s only one FDA-approved agent now, remdesivir, which has some modest activity. There’s a number of agents in clinical trials, I think a few antibody therapy agents in trials look very promising. But still, the verdict is not yet in. That is, I believe, a very logical and promising strategy towards treatment. There’s still trials ongoing with convalescent plasma. There are vaccines, which, hopefully, are imminent.

But in terms of treating patients, we’ve learned a lot, but it’s not like we have a bunch of new agents we can pull off the shelf that are really effective. But the reason I believe we could perhaps, if we can keep that slope low and not overwhelm the hospitals, I think we can keep that mortality rate down. Because, the reason I think it was so high in New York and New Jersey back in the spring, is we just became overwhelmed. There were just too many patients requiring hospitalization or intensive care. And that overwhelming of the system is certain to increase morbidity and mortality.

And, I think if we can again keep from getting overwhelmed.

I’ll tell you, Paul, from my perspective, the way to keep from getting overwhelmed is somewhat straightforward. You’ve got to wear masks. You’ve got to try to limit the number of people in close spaces. You’ve got to wash your hands. And you’ve got to keep your distance. If we can do all those things on a national level, I think we can buy ourselves the time we need to get to vaccines being deployed more broadly.

And, it seems so simple. I don’t know why or how the simple act of wearing a mask … I mean, to me it’s like, if it’s raining out, you take an umbrella, or if it’s snowing out, you put your boots on, why the simple act of putting on a mask has generated such passion among different groups, and it’s a sign of independence and resistance to not wear a mask.

It’s common sense. This is an airborne virus. If we all wore masks and followed these fairly straightforward recommendations, I don’t think you’d have to worry about shutting things down, because you’d keep it at a reasonable pace.

So, again, not having a crystal ball, my sense is we are going to see an increase even in New York and New Jersey over the next several months. I’m hopeful that since at least in New York and New Jersey, we’ve been pretty good about getting the message out for masks and distance and hand-washing. And, I can tell you at our own facilities, and even when I go out shopping, I live in New York, in my community, when I go out to stores, everybody’s got masks on. I think if we can adhere to that, we’ll be able to control this until we’re able to deploy vaccines, which is going to be the exit ramp for this.

Widespread deployment of vaccines, I believe, is how we bring this to a close at some point.

But you also know some things you didn’t know in March. For example, steroids, remdesivir, anticoagulation.

SL: It’s a great point, Paul. While we didn’t necessarily approve a bunch of new drugs that you can pull off the shelf yet for treating it, we certainly learned a lot about the disease. And, that definitely factors into our ability to improve mortality, decrease morbidity.

Steroids are an important part. Obviously, patients with significant lung disease, there’s good evidence now in randomized studies and retrospective studies that the addition of dexamethasone can improve survival. And, I think that’s a key in our armamentarium. There is some benefit to remdesivir as well in trials, although some recent studies have questioned its impact on mortality. It’s still a tool that we have that we didn’t have then in treating patients.

And also, an understanding of when to intubate and when, maybe, you don’t need intubation. There’s some evidence from studies that it may not be in the patients’ best interests to quickly put them on supportive ventilation, because of the damage caused to the lungs by positive pressure, et cetera, that perhaps there are some patients that can be maintained before being intubated.

So, I think all those things, you’re absolutely right, are going to improve patient outcomes, and maybe avoid as high a mortality as we might otherwise get. But, I still believe the key in all of that is maintaining capacity. That is, if you don’t overwhelm your system or overwhelm an individual hospital, they’re much more likely to have better outcomes, even with modest improvements over what we had in March and April with respect to therapeutics or approaches, than if you overwhelm the system.

If the system becomes overwhelmed, like we are seeing now in Utah, where folks are beginning to contemplate difficult decision-making, based on triage criteria, likelihood of survival in terms of who gets in the ICU, who has to be discharged from the ICU—that’s when I think you really start to see compounding morbidity and mortality.

Do you have enough PPE? Have you been able to build up a stash?

SL: Yes. That’s a great question. We spent much of the summer months, when numbers were more easily managed and at a low steady state, to really begin to prepare and stock up, so we wouldn’t be caught in the situations we found ourselves in in March and April.

So, right now systemwide, and certainly at the cancer institute, we are appropriately stocked with N95 masks, KN95 masks, surgical masks, gowns, shields, gloves, all the necessary PPE equipment to protect our faculty and staff that are patient-facing.

We ramped up our testing. Obviously, there’s more testing nationwide. Certainly, New Jersey has significantly ramped up its testing. We’re still in a posture where we test asymptomatic cancer patients that are going to be started on therapy to get a sense of whether those patients are positive or negative. We’ve been using PCR-based testing to this point.

About three weeks ago, we began to test patients with both PCR and an antigen test, since the antigen tests gives a result within 15 minutes. My hope is that if we show that antigen testing is good enough for us to make decisions around patients, compared to PCR, that we can reserve the PCR as a confirmatory test when needed. That will improve capacity in our emergency room to be testing folks with respiratory symptoms that begin to come in, in the winter months, when there’s confusion as to whether it may be COVID or flu.

And, as you know, the supply chain, especially for PCR testing has been strained. And so, ideally if we can show that antigen testing can be utilized as a frontline for the asymptomatic population at the cancer center, we can help to preserve the supply chain for PCR testing as it’s needed. So, that’s an area we’re moving forward with, and we’ll hopefully have some sense of that over the next couple of weeks, once we’ve got enough patients tested with both.

Are you able to set up COVID-free zones? Is that useful? Is that even feasible in such a huge health system?

SL: Certainly, for very at-risk patients, cancer patients under active treatment, transplant patients, we’ve thought a lot about how do we protect those vulnerable patients. We have COVID free units in all of our facilities. I think it’s ultimately a challenge to have truly COVID-free zones beyond the unit level.

That is to say, this hospital’s not going to admit COVID patients, just because things are becoming so widespread that—number one—you may not know that a patient is positive until they begin to undergo treatment. And, you may be the main hospital treating a particular community. And to have those patients shifted someplace at a distance regionally may complicate the care of those patients.

Ultimately, once our new cancer pavilion is completed, our goal will be to have many of our inpatient cancer patients at that facility.

Obviously, it will not have the capacity to have every cancer inpatient. But, certainly, during a period like this, an infectious disease epidemic or pandemic, a specialty-based hospital can be a focal point of trying to have that kind of a zone.

But for now, we’re looking more at strategically protecting, or separating, those very vulnerable patients, immunocompromised patients, patients under active therapy within each institution, and keeping those units free of infectious disease. So, I think that’s our main strategy right now.

How much telemedicine are you doing?

SL: Telemedicine is still a critically important component. It’s actually my hope that the government, both federal and state, look to keep us on a more accessible posture for telemedicine. As you know, the hurdles for the use of telemedicine were higher before the pandemic. I’m hoping that those hurdles that have been lowered remain lowered.

I feel that telemedicine is here to stay now. It is an important tool, and I think fits especially well into how we deliver care for cancer patients. Many of our patients are in a period of survivorship, or long-term follow-up. And, oftentimes, when you meet with those patients, you’re giving them good news. “We reviewed your scans, we reviewed your labs, everything looks great. There’s no evidence of recurrence.”

Sometimes, those appointments could be a telemedicine appointment, as opposed to the patient coming in. I mean, we certainly want to see our patients. We want to examine those patients. I’m not suggesting that telemedicine completely substitutes for that. But, there are opportunities, I think, and situations where telemedicine is very helpful. You know, second opinions, specific specialty input. You have a patient at one location who’s being seen, and you’d like to get an opinion from your expert in heme malignancies or in GI oncology at another location. That’s an ideal situation for a telemedicine consult on a patient.

And so, we’re still using it. We’re seeing some patients for initial visits for telemedicine, depending on where they are located. A lot of our initial visits though are in-person again now. We’re seeing some follow-up patients still with telemedicine. And, it’s my hope that we continue to have telemedicine as a tool, moving forward. I think it’s really helped.

Would you be able to keep cancer services going at a normal rate if this thing hits us the way you think it’s going to hit?

SL: We, surprisingly, during March, April and May, during that peak, while we saw a drop-off in volume for sure, same as many of our other colleagues in the region, we never closed down cancer services.

We continually treated patients with chemotherapy, with radiation therapy. The state had a mandate: no elective surgical procedures. But, they considered most cancer operations as urgent. So, we continued to operate on patients. Most of the access issues were not that we weren’t open for business, it was more that patients were fearful of going out and about, because of what was happening with the pandemic.

Hopefully, we’ve lowered a lot of that concern with knowledge and reality. We published two studies, one in JAMA Oncology. The one in JAMA Oncology, our radiation oncology team did surface testing for the virus throughout all of our radiation oncology facilities—waiting rooms, treatment areas, et cetera—and then, we did the same for our infusion units and our waiting rooms.

And, we found no evidence of viral contamination on surfaces in those areas, which I think is reassuring to patients, that there’s lower risk in coming in to be seen or to get treated.

We are very strict, as are many other cancer centers, in everyone wearing masks, having things rearranged so there’s appropriate social distancing, limiting the number of folks that come along with the patient, to try to decrease person density within spaces. And so, our message is and has been that patients should not be fearful of coming to be treated, or to be diagnosed, or to see us, because we’re taking every possible precaution to decrease their risk.

So, we never, even in the heat of our surge, in April, we didn’t have to deploy or detail any of our cancer providers to COVID activity.

We were able to maintain enough physician support for COVID issues, and we never had to go to final level of defense and take providers away from the cancer activity. We’re hopeful that will be the same case now, that the cancer program will continue to be able to move ahead, even with another wave.

That’s important, as you know, Paul, because as Ned Sharpless has stated and published, there’s the concern that decreased screening occurred during this pandemic, because of either sites being closed or patients being fearful of going in for routine screening.

It was not necessarily that patients with known cancers were avoiding appointments, but rather these were patients who needed routine cancer screening. For example, getting a colonoscopy when you turn 50, or patients going for mammograms, other sort of screening activity, was really impacted by this pandemic, and will lead to anywhere from 5,000 to 10,000 additional cancer cases nationwide.

We’re trying to really be in a posture now, having learned what we’ve learned, having prepared now for how to manage patients safely, to try to keep the screening going, keep the first visits going, keep the treatments going, because cancer is not going away. I think we talked about that the last time we spoke.

There are still roughly 50,000 new cancer cases a year in New Jersey, 16,000 to 17,000 deaths. That’s not taking a holiday because of the pandemic. We’re obligated to continue driving this forward and making a safe place for our patients to come.

Ned’s numbers are national projections. What about New Jersey numbers? Have you looked at those? Can you see it now?

SL: It’s a little early in terms of screening numbers for us to get a sense. As you know, Rutgers Cancer Institute co-manages the New Jersey State Cancer Registry, with the New Jersey Department of Health. There’s now a COVID registry with the New Jersey Department of Health as well. We have a memorandum of understanding making its way through approval process, which will give access to cross-reference between those two registries, which I think will be an important research tool for understanding the impact of one on the other.

But in terms of increased incidence of cases or where things have been in terms of impact on screening or mortality, I think we’ll only be able to get a true sense of that when we look back at the 2020 data, when we get midway through 2021. But when we get midway through 2021, once all the registry data has been cultivated across the state, once it’s been validated at the state level, I think we’ll be able to take a look back and get a sense of what immediate impact we have seen of COVID on cancer screening.

We also run a program with the state called, Screen NJ, which is a cancer screening program for lung cancer and colon cancer. We will begin now to look at our screening data over the last six months. But we’ve doubled our efforts in our Screen NJ program to try to get patients to their screening appointments over the last four or five months since the case numbers for COVID had gone down.

So, we’re trying to be very aggressive about that, with messaging, with information, with outreach, with navigation, to try to maintain as normal a posture for cancer screening as we possibly can.

What was the impact on your institution on the health system in terms of maybe patient volume or in terms of money?

SL: So, during March, April and May, we saw a dip in cancer patient volume.

And, I’ll speak specifically to the cancer patients across the system, since those are the numbers I have most completely. But, since May, we have seen that rebound back in terms of cancer volumes. And, right now, I believe, we will likely finish this year at- or slightly above what our volumes were in 2019.

So, we’ve come back quite a bit in terms of patient volume, especially over the last three months. And, obviously, we have two more months to go in the year—November and December—and depending on how rapidly new COVID cases, that new second wave, occurs in New Jersey, can have some impact. But, if I were going to project it out now, I think we’ll finish the year very close or maybe slightly ahead of where we were in 2019.

I think we’ve come back, certainly on the cancer service side. The system certainly saw decreases in especially surgical services, especially elective surgical cases during March, April and May, while the state had a no-elective-surgical-procedure order in place.

But, those cases came back over the summer in terms of the delays for those acute cases. I just don’t know where that will hit related to 2019 data, just because that’s outside of my sphere of responsibility.

But, I can tell you, with the cancer cases, fingers crossed, as long as the curve stays about at the slope it’s at right now, we should finish 2020 back to where we were or slightly ahead of 2019.

In terms of money, or in terms of cases?

SL: These are cases, and cases correlate to revenue to some degree. Because, each case has treatments associated with it.

Overall, I think every system was strained financially. Certainly, federal government assistance, CARES Act, et cetera, was extraordinarily helpful and necessary for all of our health systems. I think our health system, like every other health system, was challenged across different service lines.

And, as I said, especially hard hit were elective cases during March, April and May. And so, you can’t help but take a hit to your bottom line. And, certainly, as other not-for-profit health systems derived some benefit from the investments made by the federal government through the CARES Act, et cetera, in assisting, and that was critically important.

I think in terms of cancer volumes, which are the volumes again that I’m most responsible for and most intimate with, we’ve been able to maintain those volumes.

I will tell you this, though, our long-term strategic plans, and you and I have spoken in the past about the new cancer pavilion that we’re building, the first freestanding cancer hospital in the state, the pandemic has not impacted that project or that timeline.

We’re on time and on target for that project. We are on budget for that project. And still hoping to have the project completed toward the end of 2023—so about three years from now. So, fortunately, we were able to have the wherewithal to continue to navigate that in a positive direction.

But yes, obviously, the pandemic has hit our system financially. But, the system is healthy enough that I think we are weathering that storm.

What have you learned from this as a scientist? I’ve picked your brain as an administrator, that hemisphere of your brain. What about science?

SL: It’s a great question. And, I like the way you frame it. Because, as you know, I wear a couple of different hats. But, I came originally from the National Cancer Institute and the Intramural Program. So, I’m always, at my heart, a scientist. I think like a scientist, or at least I hope I do.

So, I’ve learned a few things. I’ve certainly learned the power of a well-run or well-designed clinical trial. With the overwhelming numbers of cases that we saw in March, April and May, there was a tendency to have a sense of panic, or panic prescribing, so called “kitchen sink medicine”, not understanding the disease, not understanding what might or might not work.

There was an urgency to try something to treat patients. And I respect that as a clinician, that you’re standing in front of an otherwise young person who is fairly healthy and suddenly is needing to be put on a respirator and may not make it. And so, there was a big sense of urgency in trying anything.

The scientific method is of critical importance. Because many of the treatments that were first believed to be effective turned out not to be effective, even though “common sense” might have indicated they would be. But, when you apply the rigor of a well-designed clinical trial, you learned that they weren’t.

And, I think it’s as important to rule out agents that are not effective as it is to find ones that are. Because otherwise, you spend a lot of time giving patients agents or cocktails of agents that all might have toxicity, or add to their morbidity, without any benefit. And so, it’s important to eliminate those agents from our armamentarium, or at least learn better how you might use them or how you might combine them. So, I think the scientific method is critically important there.

I was very impressed with how quickly we learned about this virus and this disease. It’s unprecedented how quickly the sequence of this virus was available—freely available online—that folks could access it to begin to learn about what the unique characteristics of this coronavirus are.

I don’t think we would have been able to see potentially three or four vaccines very close to being ready for use had it not been for that science. I mean, think about it, there’s never been a time in history, where vaccines were developed this quickly and validated through well-designed clinical trials.

And then, very basic things that the science taught us. How is this virus transmitted? Airborne transmission. How do we try to minimize the infectivity, person-to-person infectivity until we have a vaccine? And, I think simple things like wearing masks came from that.

And then finally, one of the most important things we’re learning through science is how long does it appear folks are immune to a possible second infection after they’ve been infected once?

And, I think the notion that you could treat this disease with the morbidity we know it’s associated with and the mortality we know it’s associated with, and just essentially think that letting folks just infect each other—so-called herd immunity—to get the virus to burn out, I think is inconsistent with what we now understand about this virus scientifically.

The fact that a patient with a symptomatic infection may only be immune from a second infection for four to six months, and a patient with an asymptomatic infection may only be immune for less time than that, the idea that you’d somehow ever reach herd immunity, where folks were actually immune long term, I don’t think is consistent with what we understand about this virus.

I think the only way to get to herd immunity will be through effective vaccines, if we can really optimize a vaccine. It looks like several of the vaccine candidates will fit this bill. If we are able to optimize the vaccine and squeeze out 12 or 14 months of sustained immunity from a vaccination, then folks could get boosters each year that truly could get us to the concept of herd immunity.

I think a vaccination, if the population gets vaccinated, and that would be real important, once we have a safe and effective vaccine identified and confirmed, socializing the notion that it’s important to get vaccinated, once we got the 60% of the population either vaccinated or exposed, we’d probably get to that number.

Most of the population would need to be vaccinated to get to a number that would deliver the promise of the concept of herd immunity, that is that you get it under control.

I do get concerned when we see an assault on science. Our culture, our history is rooted in advances we’ve made over time, whether it’s science that led to sanitation, whether it’s science that led to the development of engines. We’ve evolved from horses to cars to space flight, et cetera. That’s all grounded in science. And, so is health. We’ve developed treatments for many diseases. We’ve eradicated diseases. And that’s really been the foundation of the progress of our society, our economy included.

Our economy thrives with a healthy populace. And a healthy populace is based on our understanding of disease, which is rooted in science. And so, it gets a little concerning and a little frustrating when you see a pushback against science. Some think that if you silence science or you ignore it, bad things will go away. And, we obviously know that’s not the case.

So, I hope folks like Tony Fauci and others that have seen a fair amount of at least verbal assault during this period don’t lose hope and lose faith. I think the majority of us understand the important progress we make when we pay attention to scientific findings.

Speaking of which, what happened in your trial of hydroxychloroquine? How did that come out?

SL: As I told you, as soon as I had results, you’d be one of the first to know what those results were.

Do you have them?

SL: We had some early challenges both from a supply chain perspective and also some technical hurdles with respect to the viral quantification, which is the endpoint of the study. We’ve dealt with those issues and successfully put in place the supply chain that we needed, and, certainly, the decrease in cases over the summer helped us with that. And, we overcame some of the technical issues. And, we are now almost complete with analyzing those viral levels in the patients that received those agents.

Certainly, there’s a lot of evidence now that hydroxychloroquine as a single agent did not appear to have any clinical benefit in randomized studies.

What I’m hoping to learn from the completion of this study is whether there was any indication at all of an antiviral activity. Because perhaps, that agent could be used with other agents as part of a combination if there’s any evidence that there’s any activity from a virus quantification perspective.

And, that may or may not be the case. That’s why I think it’s important that we complete our analysis and that we publish this work so it can be another building brick towards understanding what options we have.

One of the areas, Paul, that’s real important is as we talked already, we have things like remdesivir, we have dexamethasone, et cetera. Those are mostly used for patients who have become hospitalized. I think the key for us, in addition to a vaccine, is we need some effective therapies that we can give to patients once they become infected, but they’re not even yet symptomatic.

Because, I really believe the key is keeping patients out of the hospital. So, better outpatient therapies are a challenge and something we need to make progress on.

I think these antibody therapies, again, the antibodies, monoclonal antibodies have shown promise in their early studies. And those might fit the bill.

I think we’re going to have to look at other agents in combination, strategies like those used for HIV now, to be able to come up with the right combination that can be given to an asymptomatic positive patient to prevent the chance that they would develop the disease. I think that and a combination of an effective vaccine is going to be our exit ramp from what we’re dealing with now.

Would it be useful to have more negative studies of hydroxychloroquine?

SL: Having data supporting one or the other is equally important. You want to eliminate agents from your repertoire as much as you want to find new ones that work so you’re not distracted with something that’s just not going to be effective. That’s why it’s critical that we complete the analysis and we publish this study, whether it’s a positive or a negative finding. Either way, I think it’s going to be important.

I know you’re thinking about this as a scientist and as a human being, what about Thanksgiving? Should people have Thanksgiving dinners, or is it better to take a break for a year?

SL: That’s a tough one, Paul. I don’t want to overstep my knowledge, expertise or my role in terms of presuming to tell folks what to do around their own personal activity or behaviors.

I’m asking you as a human being.

SL: That’s how I’m going to answer it. I can only tell you how I’m going to approach it with my family and what makes sense to me. So, we know how this virus is spread. We know the virus is spread person to person as an aerosol, meaning if you’re in an enclosed space with another person who’s infected, and you have 15 minutes of exposure to that person without wearing a mask and without social distancing, over a 24-hour period, that cumulative 15 minutes over a 24-hour period, you have a very high chance of contracting the virus.

And, we still know that this virus causes a disease which has a much higher mortality than the flu, and much higher risk of hospitalization.

And, we also know that otherwise healthy folks can get very sick from this virus. And, we don’t know that they completely recover, because some of the long-term effects, myocarditis, lung disease, etc, we are yet to fully understand. It will take us years to really understand the consequences of what it means to have been infected.

The way I’m approaching this with my own family is my immediate family will likely gather for Thanksgiving, because we’ve either spent a lot of time together, sort of co-quarantined, or my daughters, who live and work in Manhattan, will isolate themselves.

After several days of isolation, they will test themselves. They already have home saliva tests sitting in their apartments. They will test themselves, and then remain isolated until they get their test results back. And, if they’re negative, I’ll drive into the city and pick them both up—they both live in the same apartment building—and bring them back for our Thanksgiving dinner.

We are taking precautions that we are either having Thanksgiving with the nuclear family with those that have been quarantined together already for the most part, or have tested before they come back.

Thanksgiving is my favorite holiday. And, I usually have extended family all over to my house for Thanksgiving from all over the country. I have cousins up from Florida, my aunt up from Florida. I have my mom over who is in her 80s, everybody over to my house. It’s one of my favorite times of the year.

But this year, we’re just not doing that. And, it’s not making a statement about it. It’s because I don’t want to put those family members at risk or any members of my family at risk. We all know how we care about each other. We may get on Zoom at each of our tables to do a toast and to share warm feelings with each other. But I think we have to be responsible as we move forward.

Everybody has to weigh their decisions. But, I would hope part of what factors into those decisions is risk and safety to each other. And, I think we owe that to each other as our families, and we owe that to each other as our larger societal family that we have to use common sense and take care of each other, take the right precautions, even though it’s a bummer not to be able to have everybody around at the table. But you have to make certain sacrifices for the good of each other and for the good of everyone.

Is there anything we missed? Anything we didn’t cover?

SL: The only thing I would add to this is I had mentioned to you when we spoke last, that we had set up a statewide call of all the cancer programs, and that during the heat of the pandemic, we were meeting every week. We’ve continued that call. During the summer we made it once-a-month. And now, as we’re getting back into the heat of things, it’s every other week, and we’ll move back to once a week if we need to.

But that call has been incredibly useful, not just for the pandemic, but getting all the cancer leaders from the state together on a call every Friday morning has allowed us to exchange ideas, best practices, that’s led to a number of interesting, collaborative research efforts that we are going to undertake. It’s led to a lot of collegiality and assistance between the programs.

And, I think it will be of benefit to the patients and population of New Jersey that all of us are trying to work together in pursuit of more effective ways to screen, treat, and understand cancer in our population.

I’m very grateful to the other leaders of cancer centers across New Jersey for their commitment to this, and their collegiality and support in making certain that these lines of communication stay open and that we continue to share best practices on these calls.

Obviously, you try to look at the bright side of dark times. And certainly, this pandemic, there’s been a lot of dark times. But one of the bright sides has been this connection that we’ve all made and that we’re sustaining. And so, that’s something I think is important to put into what we are discussing. Because, it shows that some positives can come out of a challenging situation.

Well, thank you so much for talking with me.

Editor & Publisher


President Joe Biden has announced his intent to appoint Monica Bertagnolli as the 16th director of the National Cancer Institute—and the first woman and first chair of a clinical trials cooperative group to be named to the role.The White House announcement Aug. 10 comes nearly three weeks after news of Bertagnolli’s appointment leaked out on Twitter and in the press (The Cancer Letter, July 21, 2022).
Can you imagine, as a radiation oncologist, you have to shelter your patients in a Co-60 vault to protect them from missiles, provide them with water by melting snow, feed them, keep them warm by using a backup power generator, and evacuate them just two hours before the missile destroys the radiation oncology department? 
Research shows that cancer patients who receive navigation have improved survival, access to advanced care like clinical trials, and services like genetic testing and palliative care. Navigation often results in increased screening and patients receiving treatment sooner, resulting in improved quality of life and more cancer-free days.
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