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Face Coverings Could Save 130,000 American Lives from COVID-19 by March

Posted on by Dr. Francis Collins

Wearing a mask
Credit: Diane Baker

The coronavirus disease 2019 (COVID-19) pandemic has already claimed the lives of more than 230,000 Americans, the population of a mid-sized U.S. city. As we look ahead to winter and the coming flu season, the question weighing on the minds of most folks is: Can we pull together to contain the spread of this virus and limit its growing death toll?

I believe that we can, but only if each of us gets fully engaged with the public health recommendations. We need all Americans to do the right thing and wear a mask in public to protect themselves and their communities from spreading the virus. Driving home this point is a powerful new study that models just how critical this simple, low-cost step will be this winter and through the course of this pandemic [1].

Right now, it’s estimated that about half of Americans always wear a mask in public. According to the new study, published in Nature Medicine, if this incomplete rate of mask-wearing continues and social distancing guidelines are not adhered to, the total number of COVID-19 deaths in the United States could soar to more than 1 million by the end of February.

However, the model doesn’t accept that we’ll actually end up at this daunting number. It anticipates that once COVID mortality reaches a daily threshold of 8 deaths per 1 million citizens, U.S. states would re-instate limits on social and economic activity—as much of Europe is now doing. If so, the model predicts that by March, such state-sanctioned measures would cut the projected number of deaths in half to about 510,000—though that would still add another 280,000 lives lost to this devastating virus.

The authors, led by Christopher Murray, Institute of Health Metrics and Evaluations, University of Washington School of Medicine, Seattle, show that we can do better than that. But doing better will require action by all of us. If 95 percent of people in the U.S. began wearing masks in public right now, the death toll would drop by March from the projected 510,000 to about 380,000.

In other words, if most Americans pulled together to do the right thing and wore a mask in public, this simple, selfless act would save more than 130,000 lives in the next few months alone. If mask-wearers increased to just 85 percent, the model predicts it would save about 96,000 lives across the country.

What’s important here aren’t the precise numbers. It’s the realization that, under any scenario, this pandemic is far from over, and, together, we have it within our power to shape what happens next. If more people make the decision to wear masks in public today, it could help to delay—or possibly even prevent—the need for future shutdowns. As such, the widespread use of face coverings has the potential to protect lives while also minimizing further damage to the economy and American livelihoods. It’s a point that NIH’s Anthony Fauci and colleagues presented quite well in a recent commentary in JAMA [2].

As we anxiously await the approved vaccines for COVID-19 and other advances in its prevention and treatment, the life-saving potential of face coverings simply can’t be overstated. I know that many people are tired of this message, and, unfortunately, mask-wearing has been tangled up in political perspectives at this time of deep divisions in our country.

But think about it in the same way you think about putting on your seat belt—a minor inconvenience that can save lives. I’m careful to wear a mask outside my home every time I’m out and about. But, ultimately, saving lives and livelihoods as we head into these winter months will require a collective effort from all of us.

To do so, each of us needs to follow these three W’s: Wear a mask. Watch your distance (stay 6 feet apart). Wash your hands often.

References:

[1] Modeling COVID-19 scenarios for the United States. IHME COVID-19 Forecasting Team. Nat Med. 2020 Oct 23.

[2] Preventing the spread of SARS-CoV-2 with masks and other “low-tech” interventions. Lerner AM, Folkers, GK, Fauci AS. JAMA. 2020 October 26.

Links:

Coronavirus (COVID-19) (NIH)

Institute for Health Metrics and Evaluations (University of Washington School of Medicine, Seattle)


NIH at 80: Sharing a Timeless Message from President Roosevelt

Posted on by Dr. Francis Collins

This Saturday, October 31, marks an important milestone in American public health: the 80th anniversary of President Franklin Delano Roosevelt’s dedication of the campus of the National Institutes of Health (NIH) in Bethesda, MD. The President’s stirring speech, delivered from the steps of NIH’s brand-new Administration Building (now called Building 1), was much more than a ribbon-cutting ceremony. It gave voice to NIH’s commitment to using the power of science “to do infinitely more” for the health of all people with “no distinctions of race, of creed, or of color.”

“We cannot be a strong nation unless we are a healthy nation. And so, we must recruit not only men and materials, but also knowledge and science in the service of national strength,” Roosevelt told the crowd of about 3,000. To get a sense of what it was like to be there on that historic day, I encourage you to check out the archival video footage above from the National Archives and Records Administration (NARA).

These words from our 32nd President are especially worth revisiting for their enduring wisdom during a time of national crisis. In October 1940, with World War II raging overseas, the United States faced the prospect of defending its shores and territories from foreign forces. Yet, at the same time as he was bolstering U.S. military capacity, Roosevelt emphasized that it was also essential to use biomedical research to shore up our nation’s defenses against the threats of infectious disease. In a particularly prescient section of the speech, he said: “Now that we are less than a day by plane from the jungle-type yellow fever of South America, less than two days from the sleeping sickness of equatorial Africa, less than three days from cholera and bubonic plague, the ramparts we watch must be civilian in addition to military.”

Today, in the midst of another national crisis—the COVID-19 pandemic—a similar vision is inspiring the work of NIH. With the aim of defending the health of all populations, we are supporting science to understand the novel coronavirus that causes COVID-19 and to develop tests, treatments, and vaccines for this disease that has already killed more than 225,000 Americans and infected more than 8.6 million.

As part of the dedication ceremony, Roosevelt thanked the Luke and Helen Wilson family for donating their 70-acre estate, “Tree Tops,” to serve as a new home for NIH. (Visitors to Wilson Hall in Building 1 will see portraits of the Wilsons.) Founded in 1887, NIH had previously been housed in a small lab on Staten Island, and then in two cramped lab buildings in downtown Washington, D.C. The move to Bethesda, with NIH’s first six buildings already dotting the landscape as Roosevelt spoke, gave the small agency room to evolve into what today is the world’s largest supporter of biomedical research.

Yet, as FDR gazed out over our fledging campus on that autumn day so long ago, he knew that NIH’s true mission would extend far beyond simply conducting science to providing much-needed hope to humans around the world. As he put it in his closing remarks: “I voice for America and for the stricken world, our hopes, our prayers, our faith, in the power of man’s humanity to man.”

On the 80th anniversary of NIH’s move to Bethesda, I could not agree more. Our science—and our humanity—will get us through this pandemic and show the path forward to brighter days ahead.

Links:

Who We Are: History (NIH)

Office of NIH History and Stetten Museum (NIH)

70 Acres of Science” (Office of NIH History)

Coronavirus (COVID-19) (NIH)


Addressing the Twin Challenges of Substance Use Disorders and COVID-19

Posted on by Dr. Francis Collins

At home with Nora Volkow

The coronavirus disease 2019 (COVID-19) pandemic is having a wide range of negative impacts on people affected by a variety of health conditions. Among the hardest hit are individuals struggling with substance use disorders, with recent data indicating that suspected drug-related overdoses and deaths are on the rise across the United States [1].

One recent analysis of nationwide surveillance data, collected by the federal Overdose Detection Mapping and Application Program, found that suspected drug overdoses rose by 18 percent in March, 29 percent in April, and 42 percent in May compared to the same months in 2019 [2]. Another analysis of state and local mortality data showed that drug-related deaths have increased about 13 percent so far this year, compared to last year [3].

To find out what may be contributing to this tragic situation and learn what NIH-funded research is doing to help, I recently had a conversation with Dr. Nora Volkow, Director of NIH’s National Institute on Drug Abuse (NIDA). Here’s a condensed version of our interview, which took place via videoconference, with both of us linking in from our homes near NIH’s main campus in Bethesda, MD

Collins: Here we are today talking about two public health crises: the crisis of COVID-19 and another crisis that has been going on for quite some time, of drug overdoses and drug deaths. The opioid crisis is difficult in any circumstance, but when you add to it what’s happening right now with the global COVID-19 pandemic, it becomes difficult squared. What has happened during this pandemic?

Volkow: One of the first things that we’ve heard from the communities and the families afflicted by addiction is that the support systems that were there to help people achieve recovery are no longer present. At the same time, it’s been much harder to get access to some of the treatment programs, including hospital emergency departments that can initiate treatment. It’s also been more difficult to access syringe exchange programs and programs, like Narcotics Anonymous, that provide people with a mentor and a social support system that’s fundamental for recovery. Part of recovery is also for individuals to work at re-building their lives, and that too has become much more challenging due to the threat of COVID-19.

All of these aspects are translating into much more stress. And stress, as we know, is one of the factors that leads people to relapse. Stress is also a factor that leads many to increase the consumption of drugs.

Collins: What about the impact of the stay-at-home orders for people who are depending on social networks? You’ve talked about Narcotics Anonymous as an example. But for anybody who’s faced stress challenges, mental health issues, which often coexist with drug problems, what’s the effect of losing those face-to-face social connections?

Volkow: Isolation is difficult for anyone. We depend on others for our wellbeing. The harder our situation, the more vulnerable we are if we don’t have those support systems.

One of the major concerns that we’ve had all along is not just the enormous risk of relapse in many people, but also the risk of suicide—which is always much higher in individuals that are addicted to drugs, particularly to opioids. Indeed, there’s been an increase in the number of suicides associated with the COVID-19 pandemic, including among people that are addicted.

One of the elements we are using to try to overcome that is virtual interactions, like we are having right now. They are fulfilling, certainly for me. And when we’ve surveyed patients and families to see how much these virtual support systems are helping them, we see in many instances that this can be lifesaving. For example, with telehealth, a physician now can prescribe buprenorphine [a treatment medication] without necessarily having to see the individual physically. That’s a major breakthrough because it expands the number of people that can be treated. So, you can provide buprenorphine, and you can also provide support that someone with co-morbid mental illness may need. It’s not the same as physically being with others, but we have to recognize virtual technologies may enable greater equity in providing treatments.

Collins: What’s happened to methadone clinics, a place where people were required to show up in person every day? What’s become of people who depended on those?

Volkow: These spaces are small and there’s not enough staff, so it was very, very high risk. So, one of the positives of COVID-19 is that there was a change in the policy that enabled a methadone clinic to provide take-home methadone for patients, rather than have them come in daily and often at very restricted times, which made it incredibly difficult to comply.

We’re now trying to evaluate the outcomes when people are given take-home methadone. If we can show from evidence that the outcomes are as good as when you go in daily, then we hope that will help to transform these policies permanently.

Collins: So, there’s a silver lining in a few places. Are people who suffer from drug use disorders at increased risk of getting sick from COVID-19?

Volkow: There are many factors that place them at very, very high risk: pharmacological, structural, and social.

Pharmacological, because these drugs negatively affect multiple systems in your body and one of the main targets is the pulmonary system. If your pulmonary system already has pathology because of prior conditions, it’s much easier for the virus to actually infect you and lead to negative outcomes. That pertains to cigarette smoking that produces COPD and pulmonary damage, as well as to very toxic drugs like methamphetamine, which produces pulmonary hypertension; or opioids, which actually depress respiration and produce hypoxia.

You can see that the combination of depressed respiration and having a viral infection that attacks your lungs is not going to be positive. Indeed, it is very likely that that combination lowers the threshold for people to die from overdoses or to die from COVID-19. Drugs can also affect the cardiovascular system and the metabolic system, so all of the factors that we’ve identified as conditions that make you more vulnerable to COVID-19 are affected by drugs.

Then there are structural issues. We’ve already discussed methadone clinics, which put people together in very close spaces. Before COVID-19, one of our main priorities was to bring the treatment of substance use disorder and the screening into the healthcare system. But now the healthcare system is saturated and individuals who’ve gotten their treatment in healthcare systems no longer can access them and that restricts their ability to seek help. In our country, we basically criminalize people who take drugs, and many of them are in jail systems and prisons, where COVID-19 infections can rapidly occur. That is another element where they are at much higher risk.

Also, the number of individuals with substance use disorder who have medical insurance is much less than that of the general population. Not having such insurance is associated with a greater likelihood of having chronic medical conditions, which again is another risk factor for COVID-19. This mixes the structural with the social and, in the social category, you also have stigma.

Stigmatizing individuals with addiction makes them very vulnerable. That’s because, first of all, they are afraid to seek help—they don’t want to be discriminated against. Secondly, if they are in a situation where decisions are being made about providing medical care when resources are limited, that stigma can make them much more vulnerable.

While we are dealing with COVID-19, we cannot ignore the disparities that exist in our society. This pandemic has made it very clear how horrifically disparate health outcomes are between groups of people in our country.

Collins: Nora, you’ve been a real leader on what we might do to try to bring attention to helping people with drug use problems in the criminal justice system. This is often a point where an opportunity for treatment arises, but unfortunately that opportunity is often missed.

Volkow: One of our priorities as we address the opioid crisis is to do research in justice settings in order to be able to identify the models that lead to the best outcomes and to understand how to implement them. This has resulted in the creation of a research network that enables us to connect across the justice and the healthcare systems.

The network that started to emerge before COVID-19 hit has given us an opportunity to get direct information about what’s happening out there. From what we know, because prisons and jails are at such high risk for infection, many states—if not all—are releasing people that are not violent into their communities. Many of them have a substance use disorder. If someone has a long history of a substance use disorder, you cannot release them into the community without a support system, especially in the midst of the COVID-19 pandemic, where it’s hard to find a job and their families may be rejecting them. You can predict the outcome is going to be very poor, including dying from overdoses.

So, we now have a chance to show that treating these people in their community with appropriate support is going to lead to much better outcomes than leaving them in jail or prison. We are now working with our researchers and with appropriate agencies to figure out how to provide the support that’s necessary as individuals with substance use disorders are released into their communities. It can go both ways. Without support, the outcomes may be very poor. With support, we have the opportunity of transforming the way that we deal with addiction in this country.

Collins: A lot of people may not realize that effective medical treatment for substance use disorders does exist. Treatment has been demonstrated to change lives and improve outcomes over the long term. Still, a lot of folks out there think it’s just hopeless, or, alternatively, if someone just had a little bit more willpower, he or she would be able to take care of this. Please say a little bit about what the current treatment options are, and what the evidence is that they’re needed if you’re going to help somebody recover from a substance use disorder.

Volkow: There are medications for alcoholism and medications for nicotine use disorders. But, by far, the most effective medications are for opioid addiction. It’s very frustrating these medications are not necessarily given to patients—or sometimes even given to patients, but they reject them. I think part of the issue is because of the stigma against the medications. The opioid crisis has helped smooth that out somewhat, so there’s been a greater acceptance of medication. In partnership with the pharmaceutical industry, we have also been working towards developing extended-release formulations that make it much easier for people to take these medications.

In parallel, not just for opioid addiction, we have built up the scientific evidence for behavioral interventions that can improve outcomes for people with substance use disorder in general, if provided concurrently with medical treatment. Recognizing that there is a high risk of comorbidity with mental illness, we also need to provide treatments to address psychiatric disease problems or symptoms, as well as the addiction process. A lot of the work right now is going into creating models that allow this comprehensive treatment, tailored to the needs of the person.

Collins: Where can people who have a family member or friend who’s struggling with substance use disorder in the midst of COVID-19 go to get reliable evidence-based information about treatment programs?

Volkow: They can go to the NIDA website or the website of NIH’s sister agency, the Substance Abuse and Mental Health Services Administration (SAMHSA). One of the problems is that there hasn’t been any way of assessing the quality of treatment for substance use disorder. For many other conditions, you can check the track records of this or that hospital for this or that surgery, but such information does not exist for substance use disorder.

So, we’ve been funding researchers to develop metrics that can predict good outcomes in treatment programs. These metrics can be based on the experiences of people and family that actually took these services, and from the structural characteristics of the program, such as whether they have the evidence-based components shown by research to lead to better outcomes. Researchers are now developing “report cards” for treatment programs that hopefully will do two things: give a family member a sense of how others are rating a program, and, importantly, incentivize treatment programs to do better.

Collins: It would be wonderful to have more objective data for people searching for good answers. Now, let’s talk about HEAL, which stands for Helping to End Addiction Long-term. HEAL is a trans-agency initiative funded by the Congress to support research to address, from multiple different directions, multiple different problems relating to addiction and chronic pain.

How does the HEAL initiative need to adapt to the current health crisis of COVID-19? And what’s your institute doing to try to address some of the significant problems that have emerged in just the last two or three months?

Volkow: COVID-19 has placed HEAL and much of our other research on a very slow trajectory. For example, one program that we were very interested in expanding was the use of the emergency department for the screening of opioid use disorder and the initiation of treatment medications. Another major HEAL program was going to start using the justice system to conduct clinical trials to evaluate the outcomes of different types of medication for opioid use disorder. They are all basically on hold.

Collins: Nora, what’s your hope going forward over the next few months? What can NIH do to try to address this situation in the most effective way possible?

Volkow: I am optimistic because I can see how science can help to solve extremely challenging problems. I think this is the time for science to shine again and show us that methodologies aimed at gathering objective data to develop optimal solutions can resolve problems. But the question is: how long will it take?

I’ve been very impressed about how these devastating circumstances have led us to question the pace at which we moved projects in the past. I think it is wonderful that we have recognized that time is a luxury, that we need to move rapidly. With respect to the issue of substance use disorders, I would hope that, as we as a nation become aware of the suffering that the COVID-19 pandemic is putting on all of us, we become more empathetic to the suffering of others.

And as I see the movements across the country speaking out against injustice, I would hope that this will also extend to diseases that have been stigmatized. We need to modify our stigma so we provide the same level of importance to treating these diseases and supporting people afflicted by them.

I think that science will prevail. What is going to be important is that we also allow for our humanity in order to use that science in a way that everyone can take advantage of it.

Collins: That’s a wonderful way to wind up because I think the calling to bring together science and compassion is what drives all of us who have the privilege of working at NIH, the largest supporter of biomedical research in the world. Our purpose is clear: to find answers for all of these difficult problems that cause suffering and early death for people who deserve better.

Our vision is set on helping the most vulnerable populations right now. COVID-19 has pointed us toward that, and our discussion about those who suffer from substance use disorders also focuses on that.

I’m always one who likes to talk about hope, because, after all, that’s what we get up in the morning thinking about at NIH. We hope that our research efforts are going to lead to a new vaccine or a new treatment for COVID-19, or a better way of helping people who have been afflicted with drug problems.

Yet one of my favorite sayings is that “hope is a privilege that attaches to action.” This means that you can’t just say “Well, I hope for something,” unless you attach that hope to concrete actions you’re going to take.

Nora, your institute has been living that out. You don’t just hope that something good will happen to turn the tide of this terrible crisis of suffering and death from opioid overdoses, you’re all about action. So, thank you for your incredible dedication to the science and to the people whom we are trying to serve.

Volkow: Francis, thanks very much for your support.

References:

{1] Issue brief: Reports of increases in opioid-related overdose and other concerns during COVID pandemic, American Medical Association. Updated July 20, 2020

[2] “Cries for help’: Drug overdoses are soaring during the coronavirus pandemic.” William Wan, Healther Long. The Washington Post, July 1, 2020.

[3] “In the shadow of the pandemic, U.S. drug overdose deaths resurge to record.” Josh Katz, Abby Goodnough, Margot Sanger-Katz. July 15, 2020.

Links:

Coronavirus (COVID-19) (NIH)

Overdose Mapping Application Program (White House Office of National Drug Control Policy, Washington, D.C.)

Helping to End Addiction Long-term (HEAL) Initiative (NIH)

National Institute on Drug Abuse (NIH)

Video: Effects of COVID-19 on the Opioid Crisis: Francis Collins with Nora Volkow (National Institute on Drug Abuse/NIH)

Substance Abuse and Mental Health Services Administration (SAMHSA)


Public Health Policies Have Prevented Hundreds of Millions of Coronavirus Infections

Posted on by Dr. Francis Collins

Touchless carryout
Credit: Stock photo/Juanmonino

The alarming spread of coronavirus disease 2019 (COVID-19) last winter presented a profound threat to nations around the world. Many government leaders responded by shutting down all non-essential activities, implementing policies that public health officials were hopeful could slow the highly infectious SARS-CoV-2, the novel coronavirus that causes COVID-19.

But the shutdown has come at a heavy cost for the U.S. and global economies. It’s also taken a heavy personal toll on many of us, disrupting our daily routines—getting children off to school, commuting to the office or lab, getting together with friends and family, meeting face to face to plan projects, eating out, going to the gym—and causing lots of uncertainty and frustration.

As difficult as the shutdowns have been, new research shows that without these public health measures, things would have been much, much worse. According to a study published recently in Nature [1], the implementation of containment and mitigation strategies across the globe prevented or delayed about 530 million coronavirus infections across six countries—China, South Korea, Iran, Italy, France, and the United States. Take a moment to absorb that number—530 million. Right now, there are 8.8 million cases documented across the globe.

Estimates of the benefits of anti-contagion policies have drawn from epidemiological models that simulate the spread of COVID-19 in various ways, depending on assumptions built into each model. But models are sophisticated ways of guessing. Back when decisions about staying at home had to be made, no one knew for sure if, or how well, such approaches to limit physical contact would work. What’s more, the only real historical precedent was the 1918 Spanish flu pandemic in a very different, much-less interconnected world.

That made it essential to evaluate the pros and cons of these public health strategies within a society. As many people have rightfully asked: are the health benefits really worth the pain?

Recognizing a pressing need to answer this question, an international team of scientists dropped everything that they were doing to find out. Led by Solomon Hsiang, director of the University of California, Berkeley’s Global Policy Laboratory and Chancellor’s Professor at the Goldman School of Public Policy, a research group of 15 researchers from China, France, South Korea, New Zealand, Singapore, and the United States evaluated 1,717 policies implemented in all six countries between January 2020, when the virus began its global rise, and April 6, 2020.

The team relied on econometric methods that use statistics and math to uncover meaningful patterns hiding in mountains of data. As the name implies, these techniques are used routinely by economists to understand, in a before-and-after way, how certain events affect economic growth.

In this look-back study, scientists compare observations before and after an event they couldn’t control, such as a natural disaster or disease outbreak. In the case of COVID-19, these researchers compared public health datasets in multiple localities (e.g., states or cities) within each of the six countries before and several weeks after lockdowns. For each data sample from a given locality, the time period right before a policy deployment was the experimental “control” for the same locality several weeks after it received one or more shutdown policy “treatments.”

Hsiang and his colleagues measured the effects of all the different policies put into place at local, regional, and national levels. These included travel restrictions, business and school closures, shelter-in-place orders, and other actions that didn’t involve any type of medical treatment for COVID-19.

Because SARS-CoV-2 is a new virus, the researchers knew that early in the pandemic, everyone was susceptible, and the outbreak would grow exponentially. The scientists could then use a statistical method designed to estimate how the daily growth rate of infections changed over time within a location after different combinations of large-scale policies were put into place.

The result? Early in the pandemic, coronavirus infection rates grew 38 percent each day, on average, across the six countries: translating to a two-day doubling time. Applying all policies at once slowed the daily COVID-19 infection rate by 31 percentage points! Policies having the clearest benefit were business closures and lockdowns, whereas travel restrictions and bans on social gatherings had mixed results. Without more data, the analysis can’t specify why, but the way different countries enacted those policies might be one reason.

As we continue to try to understand and thwart this new virus and its damage to so many aspects of our personal and professional lives, these new findings add context, comfort, and guidance about the present circumstances. They tell us that individual sacrifices from staying home and canceled events contributed collectively to a huge, positive impact on the world.

Now, as various communities start cautiously to open up, we should continue to practice social distancing, mask wearing, and handwashing. This is not the time to say that the risk has passed. We are all tired of the virus and its consequences for our personal lives, but the virus doesn’t care. It’s still out there. Stay safe, everyone!

Reference:

[1] The effect of large-scale anti-contagion policies on the COVID-19 pandemic. Hsiang S, Allen D, Annan-Phan S, et al. Nature. 2020 June 8 [published online ahead of print].

Links:

Coronavirus (NIH)

Global Policy Lab: Effect of Anti-Contagion Policies (University of California, Berkeley)

Video: How much have policies to slow COVID-19 worked? (UC Berkeley)

Hsiang Lab (UC Berkeley)

Global Policy Lab Rallies for COVID-19 Research,” COVID-19 News, Goldman School of Public Policy, June 5, 2020.


Coping with the Collision of Public Health Crises: COVID-19 and Substance Use Disorders

Posted on by Dr. Francis Collins

For the past half-dozen years, I’ve had the privilege of attending the Rx Drug and Heroin Abuse Summit. And I was counting on learning more about this national crisis this April in Nashville, where I was scheduled to take part in a session with Dr. Nora Volkow, Director of NIH’s National Institute on Drug Abuse. But because of the physical distancing needed to help flatten the deadly curve of the coronavirus-19 (COVID-19) pandemic, it proved to be impossible for anyone to attend in person. Still, the summit did go on for almost three days—virtually!

Dr. Volkow and I took part by sharing a video of a recent conversation we had via videoconference. Since we couldn’t take live questions, we solicited some in advance. Here’s a condensed transcript highlighting portions of our dialogue that focused on the impact of the COVID-19 pandemic on individuals struggling with substance abuse disorders, along with all those who are trying to help them.

VOLKOW: Hello, Francis. Nice to see you, virtually!

COLLINS: Nice to see you too. I’m in my home office here, where I’ve been pretty much for the last three weeks. I’ve been stepping outdoors to occasionally get a breath of fresh air, but trying to live up to all those recommendations about social distancing—or at least physical distancing. I’m trying to keep my social connections going, even if they’re electronic.

I think we’re all feeling this is a time of some stress for us at NIH. We are trying to do everything we can to address this COVID crisis and speed up the process of developing vaccines and therapeutics and all kinds of other things. How are you doing? What’s it like being sequestered back in your home space when you are somebody with so much energy?

VOLKOW: Francis, it’s not easy. I actually am very, very restless. We probably are all experiencing that anxiety of uncertainty, looking at the news and how devastating it is. But I think what makes it easier is if we can do something. Working with everything that we have to try to help others, I think, provides some relief.

COLLINS: Yes, we’re going to talk about that right now. In fact, let’s talk about the way in which this crisis, the global pandemic called COVID-19, is colliding with another public health crisis, which is that of substance use disorder. You recently wrote about this collision in an article in the Annals of Internal Medicine. What does this mean? What are some of the unique challenges that COVID-19 brings to people suffering from addiction?

VOLKOW: I’m glad you are bringing up this point because it’s one of the issues of greatest concern for all of us who are working in the field of substance use disorders. We had not yet been able to contain the epidemic of opioid fatalities, and then we were hit by this tsunami of COVID.

We immediately can recognize the unique challenges of COVID-19 for people having an addiction. Some of these are structural; the healthcare system is not prepared to take care of them. They relate also to stigma and social issues. The concept of social distancing makes such people even more vulnerable because it interferes with many of the support systems that can help them to reach recovery. And, on top of that, drugs themselves negatively influence human physiology, making one more vulnerable to getting infected and more vulnerable to worse outcomes. So that’s why there is tremendous concern about these two epidemics colliding with one another.

COLLINS: How has this influenced treatment delivery for people with substance use disorders, who are counting on that to be able to keep themselves from slipping backward?

VOLKOW: Well, that has been very challenging. We’re hearing from multiple sources that it’s become harder for patients to be able to access treatment. And that relates, for example, to access of medications for opioid use disorders, which are the main strategy—and the most effective one—that we have to prevent people from dying from overdoses.

Some clinics are decreasing the number of patients that they can take care of. The healthcare system is also much less able to initiate persons on buprenorphine. And because of social isolation, if you overdose, the likelihood that someone can rescue you with naloxone is much lower. We don’t yet have statistics on about how that’s influencing fatalities, but we are very concerned.

COLLINS: Nora, you are one of the lead persons for NIH’s Helping to End Addiction Long-term (HEAL) initiative. How has the COVID-19 pandemic affected all the grand research plans that we had put in place as part of our big vision of how NIH could help with the substance use disorder crisis?

VOLKOW: Well, $900 million had recently been deployed on research. That is incredibly meritorious, and some of that research had already started. Unfortunately, it has had to stop almost completely. Why? Because the research that’s relying on the healthcare system, for example, is no longer able to focus on research when they have other clinical needs to meet.

Also, research to bring medication-assisted treatments to prison inmates has stopped. Prisons are not allowing the researchers to go on site because they are closing the doors to outsiders, since they are places at high risk for the spread of COVID-19. Furthermore, some institutional review boards (IRBs) are actually closing, making it impossible to recruit patients for the clinical trials. So, most studies have come to a halt. The issue now is how can we become creative and use virtual technologies to advance some of the goals that we aim to achieve with the HEAL initiative.

COLLINS: Of course, this applies to many other areas of NIH-supported research. Most clinical trials, unless they’re for life-threating conditions, are pretty much in a state of hibernation. We can’t justify having people get out there in ways that might put them at risk of COVID-19. So, yes, it’s a tough time for clinical research all over. And that’s certainly what’s happened with the opioid use disorder problems. Still, I think our teams are really devoted to making sure they make the best of this time, doing things that they can do in terms of planning and setting up data systems.

Meanwhile, bring us up to date on what’s happened as far as the state of the opioid crisis. Are there trends there that we ought to look at for a minute?

VOLKOW: Yes, it’s important to actually keep our eyes on the epidemic, because it’s changing so very rapidly. It’s gone from prescription opioids to heroin to synthetic opioids like fentanyl. And what we have observed ramping up over the past two or three years is an increase in fatalities from the use of psychostimulant drugs.

For example, the number of deaths from methamphetamine has increased five-fold over a period of six years. Similarly, deaths from cocaine are going up. The reality is that people are now dying not just from opioids, but from mixtures of drugs and stimulant drugs, most notably methamphetamine.

COLLINS: So, what can we learn from what we’ve been doing about opioid addiction, and try to apply that to this emerging methamphetamine crisis?

VOLKOW: Unfortunately, we do not have effective medications to treat methamphetamine addiction like we do for opioid use disorders. We also do not have an overdose reversal like we have with naloxone. So, in that respect, it is more challenging.

COLLINS: People sometimes think we’re only focused on trying to treat the problems that we have now. What about prevention? One of the questions we received in our HEAL mailbox was: How can small town communities create an environment where addiction does not take root in the next generation of young people? I’m sure you want to talk about the rewarding power of social interactions, even though right now we’re being somewhat deprived of those, at least face-to-face.

VOLKOW: I’m glad you’re bringing up that question, Francis. Because when you asked at the start of our conversation about how I am doing, I sort of said, “Well, it’s not easy.” But the positive component was that sense that we have a shared mission: we can help others. And the lack of a sense of mission, the lack of a purpose in life, has been identified as one of the factors that make people more vulnerable to take drugs.

Feeling irrelevant, feeling that no one cares for you, is probably one of the most devastating feelings a human being can have. Epidemiological studies show that social isolation and neglect increase dramatically the risk of taking drugs, and, if you are trying to stop taking drugs, it increases that risk of relapse. And so that’s an issue right now of great concern. The challenge is “How do we provide social support for people at risk of substance abuse during the COVID-19 pandemic?”

Also, independent of COVID-19, I think that we as a nation have to face the concept that we have made America vulnerable to drugs because we have eroded that social sense of community. If we are to prevent future generations from getting addicted to drugs, we should build meaningful interactions between people. We should give each individual an opportunity to be part of a society that appreciates them. We do need each other in very, very fundamental ways. We need others for our well-being. If we don’t have that then we become very vulnerable.

COLLINS: Well, here’s one last question from the mailbox. Somebody notes that the “L” in HEAL stands for “long-term.” That is, Helping End Addiction Long-term. The questioner asks: “What’s our vision of a long-term goal and how do we imagine getting there?”

Mine very simply is that we would have an environment that would support people in productive ways, so that the distractions of things that turn out to be destructive are not so tempting, and that the possibility of having meaning in everyone’s life becomes greater.

Ironically, because of COVID-19, we are in the midst of a circumstance where economic distress is pressing on people and social distancing is being required. Seems like we’re going the wrong way. But if you look back in history, often these times of national crisis have been times when people did have the chance to survey what really matters around them, and perhaps to regain a sense of meaning and significance. That’s my maybe slightly over-optimistic view of the current era that we’re in.

Nora, what do you think?

VOLKOW: Francis, I will agree with you. I think that we need to create a society that provides social support and allows people to participate in a meaningful way. If we want to achieve integration of people into society, one of the things that we need to do urgently is remove the stigma of addiction because when you stigmatise someone, you are socially isolating them.

No one likes to be mistreated or discriminated against. So, if you are a person who is addicted and you are afraid of discrimination, you will not seek help. You will continue to isolate. So I think as we’re dealing with the opioid crisis, as we’re dealing with COVID-19, we cannot tolerate discrimination. We cannot tolerate stigma. And we need to be very creative to identify it and to create models that will actually eliminate it.

COLLINS: That’s a wonderful view of where we need to get to. All of these developments give me hope for our capacity to deal with this crisis by working together.

I want to say to all of you who’re listening to this in your own virtual spaces, how much I admire the work that you all are doing, in a selfless way, to try to help our nation deal with what has clearly been a terrible tragedy in far too many lives. I wish you all the best in continuing those creative and energetic efforts, even in the midst of the COVID-19 pandemic. NIH wants to be your ally. We want to be your source of information. We want to be your source of evidence for what works. We want to be your friends.

So, thank you for listening, and thank you, Nora Volkow, for joining me in this discussion today with all of the talent and leadership that you represent. I wish the best health to all of you. Stay safe and keep the progress going!

Links:

Video: Fireside Chat Between NIH, NIDA Heads Addresses COVID-19, the HEAL Initiative, and the Opioids Crisis (National Institute on Drug Abuse/NIH)

COVID-19 Resources (NIDA)

COVID-19: Potential Implications for Individuals with Substance Use Disorders, Nora’s Blog (NIDA)

NIDA Director outlines potential risks to people who smoke and use drugs during COVID-19 pandemic (NIDA)

Collision of the COVID-19 and Addiction Epidemics. Volkow ND. Ann Intern Med. 2 April 2020. [Epub ahead of print]

Helping to End Addiction Long-term (HEAL) Initiative (NIH)

Rx Drug Abuse & Heroin Summit, A 2020 Virtual Experience


Celebrating 2019 Biomedical Breakthroughs

Posted on by Dr. Francis Collins

Science 2019 Biomedical Breakthroughs and a Breakdown

Happy New Year! As we say goodbye to the Teens, let’s take a look back at 2019 and some of the groundbreaking scientific discoveries that closed out this remarkable decade.

Each December, the reporters and editors at the journal Science select their breakthrough of the year, and the choice for 2019 is nothing less than spectacular: An international network of radio astronomers published the first image of a black hole, the long-theorized cosmic singularity where gravity is so strong that even light cannot escape [1]. This one resides in a galaxy 53 million light-years from Earth! (A light-year equals about 6 trillion miles.)

Though the competition was certainly stiff in 2019, the biomedical sciences were well represented among Science’s “runner-up” breakthroughs. They include three breakthroughs that have received NIH support. Let’s take a look at them:

In a first, drug treats most cases of cystic fibrosis: Last October, two international research teams reported the results from phase 3 clinical trials of the triple drug therapy Trikafta to treat cystic fibrosis (CF). Their data showed Trikafta effectively compensates for the effects of a mutation carried by about 90 percent of people born with CF. Upon reviewing these impressive data, the Food and Drug Administration (FDA) approved Trikafta, developed by Vertex Pharmaceuticals.

The approval of Trikafta was a wonderful day for me personally, having co-led the team that isolated the CF gene 30 years ago. A few years later, I wrote a song called “Dare to Dream” imagining that wonderful day when “the story of CF is history.” Though we’ve still got more work to do, we’re getting a lot closer to making that dream come true. Indeed, with the approval of Trikafta, most people with CF have for the first time ever a real chance at managing this genetic disease as a chronic condition over the course of their lives. That’s a tremendous accomplishment considering that few with CF lived beyond their teens as recently as the 1980s.

Such progress has been made possible by decades of work involving a vast number of researchers, many funded by NIH, as well as by more than two decades of visionary and collaborative efforts between the Cystic Fibrosis Foundation and Aurora Biosciences (now, Vertex) that built upon that fundamental knowledge of the responsible gene and its protein product. Not only did this innovative approach serve to accelerate the development of therapies for CF, it established a model that may inform efforts to develop therapies for other rare genetic diseases.

Hope for Ebola patients, at last: It was just six years ago that news of a major Ebola outbreak in West Africa sounded a global health emergency of the highest order. Ebola virus disease was then recognized as an untreatable, rapidly fatal illness for the majority of those who contracted it. Though international control efforts ultimately contained the spread of the virus in West Africa within about two years, over 28,600 cases had been confirmed leading to more than 11,000 deaths—marking the largest known Ebola outbreak in human history. Most recently, another major outbreak continues to wreak havoc in northeastern Democratic Republic of Congo (DRC), where violent civil unrest is greatly challenging public health control efforts.

As troubling as this news remains, 2019 brought a needed breakthrough for the millions of people living in areas susceptible to Ebola outbreaks. A randomized clinical trial in the DRC evaluated four different drugs for treating acutely infected individuals, including an antibody against the virus called mAb114, and a cocktail of anti-Ebola antibodies referred to as REGN-EB3. The trial’s preliminary data showed that about 70 percent of the patients who received either mAb114 or the REGN-EB3 antibody cocktail survived, compared with about half of those given either of the other two medicines.

So compelling were these preliminary results that the trial, co-sponsored by NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and the DRC’s National Institute for Biomedical Research, was halted last August. The results were also promptly made public to help save lives and stem the latest outbreak. All Ebola patients in the DRC treatment centers now are treated with one or the other of these two options. The trial results were recently published.

The NIH-developed mAb114 antibody and the REGN-EB3 cocktail are the first therapeutics to be shown in a scientifically rigorous study to be effective at treating Ebola. This work also demonstrates that ethically sound clinical research can be conducted under difficult conditions in the midst of a disease outbreak. In fact, the halted study was named Pamoja Tulinde Maisha (PALM), which means “together save lives” in Kiswahili.

To top off the life-saving progress in 2019, the FDA just approved the first vaccine for Ebola. Called Ervebo (earlier rVSV-ZEBOV), this single-dose injectable vaccine is a non-infectious version of an animal virus that has been genetically engineered to carry a segment of a gene from the Zaire species of the Ebola virus—the virus responsible for the current DRC outbreak and the West Africa outbreak. Because the vaccine does not contain the whole Zaire virus, it can’t cause Ebola. Results from a large study in Guinea conducted by the WHO indicated that the vaccine offered substantial protection against Ebola virus disease. Ervebo, produced by Merck, has already been given to over 259,000 individuals as part of the response to the DRC outbreak. The NIH has supported numerous clinical trials of the vaccine, including an ongoing study in West Africa.

Microbes combat malnourishment: Researchers discovered a few years ago that abnormal microbial communities, or microbiomes, in the intestine appear to contribute to childhood malnutrition. An NIH-supported research team followed up on this lead with a study of kids in Bangladesh, and it published last July its groundbreaking finding: that foods formulated to repair the “gut microbiome” helped malnourished kids rebuild their health. The researchers were able to identify a network of 15 bacterial species that consistently interact in the gut microbiomes of Bangladeshi children. In this month-long study, this bacterial network helped the researchers characterize a child’s microbiome and/or its relative state of repair.

But a month isn’t long enough to determine how the new foods would help children grow and recover. The researchers are conducting a similar study that is much longer and larger. Globally, malnutrition affects an estimated 238 million children under the age 5, stunting their normal growth, compromising their health, and limiting their mental development. The hope is that these new foods and others adapted for use around the world soon will help many more kids grow up to be healthy adults.

Measles Resurgent: The staff at Science also listed their less-encouraging 2019 Breakdowns of the Year, and unfortunately the biomedical sciences made the cut with the return of measles in the U.S. Prior to 1963, when the measles vaccine was developed, 3 to 4 million Americans were sickened by measles each year. Each year about 500 children would die from measles, and many more would suffer lifelong complications. As more people were vaccinated, the incidence of measles plummeted. By the year 2000, the disease was even declared eliminated from the U.S.

But, as more parents have chosen not to vaccinate their children, driven by the now debunked claim that vaccines are connected to autism, measles has made a very preventable comeback. Last October, the Centers for Disease Control and Prevention (CDC) reported an estimated 1,250 measles cases in the United States at that point in 2019, surpassing the total number of cases reported annually in each of the past 25 years.

The good news is those numbers can be reduced if more people get the vaccine, which has been shown repeatedly in many large and rigorous studies to be safe and effective. The CDC recommends that children should receive their first dose by 12 to 15 months of age and a second dose between the ages of 4 and 6. Older people who’ve been vaccinated or have had the measles previously should consider being re-vaccinated, especially if they live in places with low vaccination rates or will be traveling to countries where measles are endemic.

Despite this public health breakdown, 2019 closed out a memorable decade of scientific discovery. The Twenties will build on discoveries made during the Teens and bring us even closer to an era of precision medicine to improve the lives of millions of Americans. So, onward to 2020—and happy New Year!

Reference:

[1] 2019 Breakthrough of the Year. Science, December 19, 2019.

NIH Support: These breakthroughs represent the culmination of years of research involving many investigators and the support of multiple NIH institutes.


Global Effort to End AIDS Would Save Millions of Lives

Posted on by Dr. Francis Collins

Prevent HIV AIDS

Scanning electromicrograph of an HIV-infected T cell/NIAID

Almost 37 million people around the world are now infected with human immunodeficiency virus (HIV), the virus that causes AIDS [1]. But many don’t know they are infected or lack access to medical care. Even though major strides have been made in treating the infection, less than half receive antiretroviral therapy (ART) that could prevent full-blown AIDS and reduce the likelihood of the virus being transmitted to other people. Now, a new report restores hope that an end to this very serious public health challenge could be within reach—but that will require a major boost in commitment and resources.

The study conducted by an NIH-funded research team evaluated the costs and expected life-saving returns associated with ambitious goals for HIV testing and treatment, the so-called 90-90-90 program, issued by the Joint United Nations Programme on HIV/AIDS (UNAIDS) in 2014 [2]. The new analysis, based on HIV disease progression and treatment data in South Africa, finds that those goals, though expensive to implement, can be achieved cost-effectively, potentially containing the AIDS epidemic and saving many millions of lives around the globe.


LabTV: Curious About Improving American Indian Health

Posted on by Dr. Francis Collins

Deana Around HimNovember is National American Indian and Alaska Native Heritage Month, and so I can’t think of a better time to introduce you to Deana Around Him, a social and behavioral health researcher active in efforts to improve the health of infants and children in native communities. Deana is a member of the Cherokee Nation of Oklahoma, where she grew up with her mother and sisters after losing her father to a car accident when she was only 3 years old.

Deana’s father was a pharmacist, and, as a child, Deana thought that she would follow in his footsteps. But after participating in the National Youth Leadership Forum for Medicine one summer in high school, she set her sights instead on a career in medicine and made her way to Brown University, Providence, RI. Attending an Ivy League school was something she “never in her wildest dreams imagined” as a kid.


LabTV: Curious About Cancer Patients’ Quality of Life

Posted on by Dr. Francis Collins

Katie MartinezKatie Martinez struggled mightily with math in high school, but now she’s eagerly pursuing a biomedical research career that’s all about crunching numbers. So, what happened to Katie? Cancer is what happened, specifically being diagnosed with breast cancer when she was just a few years out of college.

While growing up in Alexandria, VA, Martinez had little interest in science or math, doing so poorly that she even had to enroll in some remedial classes. So, it wasn’t surprising that she chose to major in history when she went off to Carnegie Mellon University in Pittsburgh. There, Martinez eventually became intrigued by the many ways in which “built environments”—the places and circumstances in which people live—can affect the health of both individuals and communities. Her interest in these social determinants of health led her to pursue a Master’s degree in Public Health at the University of California, Los Angeles.


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