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Help for Babies Born Dependent on Opioids

Posted on by Lawrence Tabak, D.D.S., Ph.D.

A woman sitting in bed feeds a sleepy newborn baby with a bottle
Credit: Shutterstock/Alena Ozerova

It’s been estimated that every 18 minutes in the United States, a newborn baby starts life with painful withdrawals from exposure to opioids in the womb. It’s called neonatal opioid withdrawal syndrome (NOWS), and it makes for a challenging start in life. These infants may show an array of withdrawal symptoms, including tremors, extreme irritability, and problems eating and sleeping.

Many of these infants experience long, difficult hospital stays to help them manage their withdrawal symptoms. But because hospital staff have no established evidence-based treatment standards to rely on, there is substantial variation in NOWS treatment around the country. There also are many open questions about the safest and most-effective way to support these babies and their families.

But answers are coming. The New England Journal of Medicine just published clinical trial results that evaluated care for infants with NOWS and which offer some much needed—and rather encouraging—data for families and practitioners [1]. The data are from the Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW) trial, led by Leslie W. Young, The University of Vermont’s Larner College of Medicine, Burlington, and her colleagues Lori Devlin and Stephanie Merhar.

The ESC-NOW study is supported through the Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Collaborative. ACT NOW is an essential part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, an aggressive effort to speed scientific solutions to stem the national opioid public health crisis and improve lives.

The latest study puts to the test two different approaches to care for newborns with NOWS. The first approach relies on the Finnegan Neonatal Abstinence Scoring Tool. For almost 50 years, doctors primarily assessed NOWS using this tool. It is based on a scoring system of 21 signs of withdrawal, including disturbances in a baby’s nervous system, metabolism, breathing, digestion, and more. However, there have been concerns that this scoring tool has led to an overreliance on treating babies with opioid medications, including morphine and methadone.

The other approach is known as Eat, Sleep, Console (ESC) care [2]. First proposed in 2014, ESC care has been adopted in many hospitals around the world. Rather than focusing on a long list of physical signs of withdrawal, this approach relies on a simpler functional assessment of whether an infant can eat, sleep, and be consoled. It emphasizes treatments other than medication, such as skin-to-skin contact, breastfeeding, and care from their mothers or other caregivers in a calm and nurturing environment.

The ESC care approach places an emphasis on the use of supportive interventions and aims to empower families in the care and nurturing of their infants. While smaller quality improvement studies of ESC have been compelling, the question at issue is whether the Eat, Sleep, Console care approach can reduce the time until infants with NOWS are medically ready to go home from the hospital in a wide variety of hospital settings—and, most importantly, whether it can do so safely.

To find out, the ESC-NOW team enrolled 1,305 infants with NOWS who were born after at least 36 weeks gestation. The study’s young participants were largely representative of infants with NOWS in the U.S., although non-Hispanic Black and Hispanic infants were slightly overrepresented. The babies were born at one of 26 U.S. hospitals, and each hospital was randomly assigned to transition from usual care using the Finnegan tool to the ESC care approach at a designated time.

Each hospital had a three-month transition period between the usual care and the ESC to allow clinical teams time to train on the new approach. The trial primarily aimed to understand if there was a significant difference in how long newborns with NOWS spent in the hospital before being medically ready for discharge between those receiving usual care versus those receiving ESC care. Researchers also assessed infants for safety, tracking both safety events that occurred during the hospital stay and events that occurred after the baby left the hospital, such as non-accidental trauma or death during an infant’s first three months.

The reported results reflect 837 of the 1,305 infants, who met the study definition of being medically ready for discharge. Infants who were discharged before meeting the study criteria, which were informed by the 2012 American Academy of Pediatrics recommendations for monitoring of infants with NOWS, were not included in the primary analysis.

Among the 837 infants, those who received ESC care were medically ready for discharge significantly sooner than those who received usual care. On average, they were medically ready to go home after about eight days compared to almost 15 days for the usual care group.

Many fewer infants in the ESC care group were treated with opioids compared to the usual care group (19.5 percent versus 52.0 percent). In more good news for ESC care, there was no difference in safety outcomes through the first three months despite the shorter hospital stays and reduced opioid treatment in the hospital. Infants who were cared for using the ESC care approach were no more likely to visit the doctor’s office, emergency room, or hospital after being discharged from the hospital.

More long-term study is needed to evaluate these children over months and years as they continue to develop and grow. Many of the infants in this study will be evaluated for the first two years of life to assess the long-term impact of ESC care on development and other outcomes. These findings offer encouraging early evidence that the ESC care approach is safe and effective. Although there was some variability in the outcomes, this study also shows that this approach can work well across diverse hospitals and communities.

The ESC-NOW trial is just one portion of the NIH Heal Initiative’s ACT NOW program, focused on gathering scientific evidence on how to care for babies with NOWS. Other studies are evaluating how to safely wean babies who do receive treatment with medication off opioids more quickly. The ACT NOW Longitudinal Study also will enroll at least 200 babies with prenatal opioid exposure and another 100 who were not exposed to better understand the long-term implications of early opioid exposure.

I’ve been anxious to see the results of the ESC-NOW study for a few months. It’s been worth the wait. The results show that we’re headed in the right direction with learning how best to treat NOWS and help to improve the lives of these young children and their families in the months and years ahead.

References:

[1] Eat, Sleep, Console Approach versus usual care for neonatal opioid withdrawal. Young LW, Ounpraseuth ST, Merhar SL, Newman S, Snowden JN, Devlin LA, et al. NEJM, 2023 Apr 30 [Published online ahead of print]

[2] An initiative to improve the quality of care of infants with neonatal abstinence syndrome. Grossman MR, Berkwitt AK, Osborn RR, Xu Y, Esserman DA, Shapiro ED, Bizzarro MJ. Pediatrics. 2017 Jun;139(6):e20163360.

Links:

SAMHSA’s National Helpline (Substance Abuse and Mental Health Services Administration, Rockville, MD)

“Eat, Sleep, Console” reduces hospital stay and need for medication among opioid-exposed infants, NIH news release, May 1, 2023

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

Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)

Environmental Influences on Child Health Outcomes (ECHO) Program (NIH)

Leslie Young (The University of Vermont, Larner College of Medicine, Burlington)

NIH Support: The Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Center for Advancing Translational Sciences; Office of the Director


Research to Address the Real-Life Challenges of Opioid Crisis

Posted on by Lawrence Tabak, D.D.S., Ph.D.

A man and two women each sit in white cushioned chairs talking on a stage.
Caption: NIDA Director Nora Volkow (center), HEAL Initiative Director Rebecca Baker (right), and I discuss NIH’s latest efforts to combat opioid crisis. Credit: Pierce Harman for Rx Drug Abuse & Heroin Summit 2022.

While great progress has been made in controlling the COVID-19 pandemic, America’s opioid crisis continues to evolve in unexpected ways. The opioid crisis, which worsened during the pandemic and now involves the scourge of fentanyl, claims more than 70,000 lives each year in the United States [1]. But throughout the pandemic, NIH has continued its research efforts to help people with a substance use disorder find the help that they so need. These efforts include helping to find relief for the millions of Americans who live with severe and chronic pain.

Recently, I traveled to Atlanta for the Rx and Illicit Drug Summit 2022. While there, I moderated an evening fireside chat with two of NIH’s leaders in combating the opioid crisis: Nora Volkow, director of the National Institute on Drug Abuse (NIDA); and Rebecca Baker, director of Helping to End Addiction Long-term® (HEAL) initiative. What follows is an edited, condensed transcript of our conversation.

Tabak: Let’s start with Nora. When did the opioid crisis begin, and how has it changed over the years

Volkow: It started just before the year 2000 with the over-prescription of opioid medications. People were becoming addicted to them, many from diverted product. By 2010, CDC developed guidelines that decreased the over-prescription. But then, we saw a surge in heroin use. That turned the opioid crisis into two problems: prescription opioids and heroin.

In 2016, we encountered the worst scourge yet. It is fentanyl, an opioid that’s 50 times more potent than heroin. Fentanyl is easily manufactured, and it’s easier than other opioids to hide and transport across the border. That makes this drug very profitable.

What we have seen during the pandemic is the expansion of fentanyl use in the United States. Initially, fentanyl made its way to the Northeast; now it’s everywhere. Initially, it was used to contaminate heroin; now it’s used to contaminate cocaine, methamphetamine, and, most recently, illicit prescription drugs, such as benzodiazepines and stimulants. With fentanyl contaminating all these drugs, we’re also seeing a steep rise in mortality from cocaine and methamphetamine use in African Americans, American Indians, and Alaska natives.

Tabak: What about teens? A recent study in the journal JAMA reported for the first time in a decade that overdose deaths among U.S. teens rose dramatically in 2020 and kept rising through 2021 [2]. Is fentanyl behind this alarming increase?

Volkow: Yes, and it has us very concerned. The increase also surprised us. Over the past decade, we have seen a consistent decrease in adolescent drug use. In fact, there are some drugs that have the lowest usage rates that we’ve ever recorded. To observe this more than doubling of overdose deaths from fentanyl before the COVID pandemic was a major surprise.

Adolescents don’t typically use heroin, nor do they seek out fentanyl. Our fear is adolescents are misusing illicit prescriptions contaminated with fentanyl. Because an estimated 30-40 percent of those tainted pills contain levels of fentanyl that can kill you, it becomes a game of Russian roulette. This dangerous game is being played by adolescents who may just be experimenting with illicit pills.

Tabak: For people with substance use disorders, there are new ways to get help. In fact, one of the very few positive outcomes of the pandemic is the emergence of telehealth. If we can learn to navigate the various regulatory issues, do you see a place for telehealth going forward?

Volkow: When you have a crisis like this one, there’s a real need to accelerate interventions and innovation like telehealth. It certainly existed before the pandemic, and we knew that telehealth was beneficial for the treatment of substance use disorders. But it was very difficult to get reimbursement, making access extremely limited.

When COVID overwhelmed emergency departments, people with substance use disorders could no longer get help there. Other interventions were needed, and telehealth helped fill the void. It also had the advantage of reaching rural populations in states such as Kentucky, West Virginia, Ohio, where easy access to treatment or unique interventions can be challenging. In many prisons and jails, administrators worried about bringing web-based technologies into their facilities. So, in partnership with the Justice Department, we have created networks that now will enable the entry of telehealth into jails and prisons.

Tabak: Rebecca, it’s been four years since the HEAL initiative was announced at this very summit in 2018. How is the initiative addressing this ever-evolving crisis?

Baker: We’ve launched over 600 research projects across the country at institutions, hospitals, and research centers in a broad range of scientific areas. We’re working to come up with new treatment options for pain and addiction. There’s exciting research underway to address the craving and sleep disruption caused by opioid withdrawal. This research has led to over 20 investigational new drug applications to the FDA. Some are for repurposed drugs, compounds that have already been shown to be safe and effective for treating other health conditions that may also have value for treating addiction. Some are completely novel. We have also initiated the first testing of an opioid vaccine, for oxycodone, to prevent relapse and overdose in high-risk individuals.

Tabak: What about clinical research?

Baker: We’re testing multiple different treatments for both pain and addiction. Not everyone with pain is the same, and not every treatment is going to work the same for everyone. We’re conducting clinical trials in real-world settings to find out what works best for patients. We’re also working to implement lifesaving, evidence-based interventions into places where people seek help, including faith, community, and criminal justice settings.

Tabak: The pandemic highlighted inequities in our health-care system. These inequities afflict individuals and populations who are struggling with addiction and overdose. Nora, what needs to be done to address the social determinants of racial disparities?

Volkow: This is an extraordinarily important question. As you noted, certain racial and ethnic groups had disproportionately higher mortality rates from COVID. We have seen the same with overdose deaths. For example, we know that the most important intervention for preventing overdoses is to initiate medications such as methadone, buprenorphine or vivitrol. But Black Americans are initiated on these medications at least five years later than white Americans. Similarly, Black Americans also are less likely to receive the overdose-reversal medication naloxone.

That’s not right. We must ask what are the core causes of limited access to high-quality health care? Low income is a major contributing factor. Helping people get an education is one of the most important factors to address it. Another factor is distrust of the medical system. When racial and ethnic discrimination is compounded by discrimination because a person has a substance use disorder, you can see why it becomes very difficult for some to seek help. As a society, we certainly need to address racial discrimination. But we also need to address discrimination against substance use disorders in people of all races who are vulnerable.

Baker: Our research is tackling these barriers head on with a direct focus on stigma. As Nora alluded to, oftentimes providers may not offer lifesaving medication to some patients, and we’ve developed and are testing research training to help providers recognize and address their own biases and behaviors in caring for different populations.

We have supported research on the drivers of equity. A big part of this is engaging with people with lived experience and making sure that the interventions being designed are feasible in the real world. Not everyone has access to health insurance, transportation, childcare—the support that they may need to sustain treatment and recovery. In short, our research is seeking ways to enhance linkage to treatment.

Nora mentioned the importance of telehealth in improving equity. That’s another research focus, as well as developing tailored, culturally appropriate interventions for addressing pain and addiction. When you have this trust issue, you can’t always go in with a prescription or a recommendation from a physician. So in American and Alaskan native communities, we’re integrating evidence-based prevention approaches with traditional practices like wellness gatherings, cooking together, use of sage and spirituality, along with community support, and seeing if that encourages and increases the uptake of these prevention approaches in communities that need it so much.

Tabak: The most heartbreaking impact of the opioid crisis has been the infants born dependent on opioids. Rebecca, what’s being done to help the very youngest victims of the opioid crisis born with neonatal opioid withdrawal syndrome, or NOWS?

Baker: Thanks for asking about the infants. Babies with NOWS undergo withdrawal at birth and cry inconsolably, often with extreme stomach upset and sometimes even with seizures. Our research found that hospitals across the country vary greatly in how they treat these babies. Our program, ACT NOW, or Advancing Clinical Trials in Neonatal Opioid Withdrawal, aims to provide concrete guidance for nurses in the NICU treating these infants. One of the studies that we call Eat, Sleep, Console focuses on the abilities of the baby. Our researchers are testing if the ability to eat, sleep, or be consoled increases bonding with the mother and if it reduces time in the hospital, as well as other long-term health outcomes.

In addition to that NOWS program, we’ve also launched the HEALthy Brain and Child Development Study, or HBCD, that seeks to understand the long-term consequences of opioid exposure together with all the other environmental and other factors the baby experiences as they grow up. The hope is that together these studies will inform future prevention and treatment efforts for both mental health and also substance use and addiction.

Tabak: As the surge in heroin use and appearance of fentanyl has taught us, the opioid crisis has ever-changing dynamics. It tells us that we need better prevention strategies. Rebecca, could you share what HEAL is doing about prevention?

Baker: Prevention has always been a core component of the HEAL Initiative in a number of ways. The first is by preventing unnecessary opioid exposures through enhanced and evidence-based pain management. HEAL is supporting research on new small molecules, new devices, new biologic therapeutics that could treat pain and distinct pain conditions without opioids. And we’re also researching and providing guidance for clinicians on strategies for managing pain without medication, including acupuncture and physical therapy. They can often be just as effective and more sustainable.

HEAL is also working to address risky opioid use outside of pain management, especially in high-risk groups. That includes teens and young adults who may be experimenting, people lacking stable housing, patients who are on high-dose opioids for pain management, or they maybe have gone off high-dose opioids but still have them in their possession.

Finally, to prevent overdose we have to give naloxone to the people who need it. The HEALing Communities Study has taken some really innovative approaches to providing naloxone in libraries, on the beach, and places where overdoses are actually happening, not just in medical settings. And I think that will be, in our fight against the overdose crisis, a key tool.

Volkow: Larry, I’d like to add a few words on prevention. There are evidence-based interventions that have been shown to be quite effective for preventing substance use among teenagers and young adults. And yet, they are not implemented. We have evidence-based interventions that work for prevention. We have evidence-based interventions that work for treatment. But we don’t provide the resources for their implementation, nor do we train the personnel that can carry it over.

Science can give us tools, but if we do not partner at the next level for their implementation, those tools do not have the impact they should have. That’s why I always bring up the importance of policy in the implementation phase.

Tabak: Rebecca, the opioid crisis got started with a lack of good options for treating pain. Could you share with us how HEAL’s research efforts are addressing the needs of millions of Americans who experience both chronic pain and opioid use disorder?

Baker: It’s so important to remember people with pain. We can’t let our efforts to combat the opioid crisis make us lose sight of the needs of the millions of Americans with pain. One hundred million Americans experience pain; half of them have severe pain, daily pain, and 20 million have such severe pain that they can’t do things that are important to them in their life, family, job, other activities that bring their life meaning.

HEAL recognizes that these individuals need better options. New non-addictive pain treatments. But as you say, there is a special need for people with a substance use disorder who also have pain. They desperately need new and better options. And so we recently, through the HEAL Initiative, launched a new trials network that couples medication-based treatment for opioid use disorders, so that’s methadone or buprenorphine, with new pain-management strategies such as psychotherapy or yoga in the opioid use disorder treatment setting so that you’re not sending them around to lots of different places. And our hope is that this integrated approach will address some of the fragmented healthcare challenges that often results in poor care for these patients.

My last point would be that some patients need opioids to function. We can’t forget as we make sure that we are limiting risky opioid use that we don’t take away necessary opioids for these patients, and so our future research will incorporate ways of making sure that they receive needed treatment while also preventing them from the risks of opioid use disorder.

Tabak: Rebecca, let me ask you one more question. What do you want the folks here to remember about HEAL?

Baker: HEAL stands for Helping to End Addiction Long-term, and nobody knows more than the people in this room how challenging and important that really is. We’ve heard a little bit about the great promise of our research and some of the advances that are coming through our research pipeline, new treatments, new guidance for clinicians and caregivers. I want everyone to know that we want to work with you. By working together, I’m confident that we will tailor these new advances to meet the individual needs of the patients and populations that we serve.

Tabak: Nora, what would you like to add?

Volkow: This afternoon, I met with two parents who told me the story of how they lost their daughter to an overdose. They showed me pictures of this fantastic girl, along with her drawings. Whenever we think about overdose deaths in America, the sheer number—75,000—can make us indifferent. But when you can focus on one person and feel the love surrounding that life, you remember the value of this work.

Like in COVID, substance use disorders are a painful problem that we’re all experiencing in some way. They may have upset our lives. But they may have brought us together and, in many instances, brought out the best that humans can do. The best, to me, is caring for one another and taking the responsibility of helping those that are most vulnerable. I believe that science has a purpose. And here we have a purpose: to use science to bring solutions that can prevent and treat those suffering from substance use disorders.

Tabak: Thanks to both of you for this enlightening conversation.

References:

[1] Drug overdose deaths, Centers for Disease Control and Prevention, February 22, 2022.

[2] Trends in drug overdose deaths among US adolescents, January 2010 to June 2021. Friedman J. et al. JAMA. 2022 Apr 12;327(14):1398-1400.

Links:

Video: Evening Plenary with NIH’s Lawrence Tabak, Nora Volkow, and Rebecca Baker (Rx and Illicit Drug Summit 2022)

SAMHSA’s National Helpline (Substance Abuse and Mental Health Services Administration, Rockville, MD)

Opioids (National Institute on Drug Abuse/NIH)

Fentanyl (NIDA)

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

Rebecca Baker (HEAL/NIH)

Nora Volkow (NIDA)


Analysis of Death Records Shows Growing Disparities in Opioid Epidemic

Posted on by Lawrence Tabak, D.D.S., Ph.D.

Diverse group of people sitting in circle in group therapy session.
Credit: Zoran Zeremski/Shutterstock

Based on the most recent data, about 100,000 people now die in the United States from drug overdoses over the course of a year, about half of them from synthetic opioids and primarily fentanyl [1,2]. That’s more than a 30 percent increase over 2019 levels, and a reminder that the exact causes of these tragic overdoses continue to evolve over time, including from changes in how people use drugs.

Now, an NIH-funded study provides a detailed look at one shift in drug use: overdose deaths involving some combination of opioids and stimulant drugs, including cocaine and methamphetamine. These latest findings on the nation’s opioid epidemic, from a thorough analysis of death certificate data over a decade and up to the start of the pandemic, showed an alarming rise in overdose deaths from combined opioids and stimulants in all parts of the country.

The data also reveal extremely troubling racial disparities. Opioid/stimulant deaths among Black Americans have risen at more than three times the rate seen among non-Hispanic white people, especially in Eastern states. In other parts of the country, there’s also been a disproportionate increase in these combination overdose deaths among Hispanic and Asian Americans.

The findings, published in the American Journal of Epidemiology, suggest that efforts to prevent opioid overdoses, including wide distribution of naloxone, should target not only people who primarily use opioids but those who primarily use crack cocaine or other street drugs [3].

The new study comes from a team led by Tarlise Townsend, NYU Langone Center for Opioid Epidemiology and Policy, New York, and David Kline, Wake Forest University School of Medicine, Winston-Salem, NC. They wanted to dig deeper into the increase in combined stimulant/opioid overdose deaths observed over the last decade.

To do so, the researchers analyzed individual death certificate data for overdoses from the 2007-2019 National Center for Health Statistics. They grouped them by state as well as by race and ethnicity (non-Hispanic white, non-Hispanic Black, Hispanic, and non-Hispanic Asian American/Pacific Islander). They also analyzed separately deaths from opioids in combination with cocaine and those involving methamphetamine and other stimulants (MOS).

These national data showed that cocaine/opioid mortality increased 575 percent among Black people compared to 184 percent in white people. The pattern for methamphetamines and other stimulants combined with opioids showed an even starker and truly terrible pattern. MOS/opioid mortality rose by 16,200 percent in Black people versus 3,200 percent in white people.

The study uncovered some other noteworthy regional trends from 2007-2019, including:

• By 2019, rates of cocaine/opioid mortality in Black Americans were considerably higher than among white Americans in 47 of the 50 states.

• The largest disparity between Black Americans and white Americans was found in MOS/opioid mortality in the Midwest.

• MOS/opioid death rates among Black Americans increased 66 percent per year in the Northeast, 72 percent per year in the Midwest, and 57 percent in the South.

• In the South, deaths from cocaine and opioids grew 26 percent per year in Black Americans, 27 percent per year in Hispanic people, and 12 percent per year in non-Hispanic white people.

• MOS/opioid death rates among Asian Americans and Pacific Islanders increased faster than in white people in the West and Northeast.

• MOS/opioid death rates also grew faster among Hispanic people than among white people in the West, Northeast, and upper Midwest.

The results show that the nature of overdose deaths vary considerably from state to state and even within the same region of the country. More study, however, is needed to understand fully the observed trends and their causes.

For instance, it’s not clear how often such opioid/stimulant deaths stem from intentional use of these drugs in combination versus growing contamination of stimulant drugs, such as cocaine, with synthetic fentanyl, which is the extremely potent and dangerous opioid that’s largely responsible for the recent uptick in stimulant/opioid overdose deaths.

As researchers work to get these answers, this study comes as a reminder that successfully tackling the opioid epidemic through NIH’s Helping to End Addiction Long-term (HEAL) Initiative and other efforts will require a multi-pronged approach, including concerted efforts to improve prevention and treatment for opioid misuse and addiction. It also will be essential to ensure that such advances will reach those who are being hit hardest by the opioid epidemic, including minority and marginalized communities.

References:

[1] 12 month-ending provisional number of drug overdose deaths. Centers for Disease Control and Prevention. January 1, 2022.

[2] Drug overdose deaths. Centers for Disease Control and Prevention. March 3, 2021.

[3] Racial/ethnic and geographic trends in combined stimulant/opioid overdoses, 2007-2019. Townsend T, Kline D, Rivera-Aguirre A, Bunting AM, Mauro PM, Marshall BDL, Martins SS, Cerda M. American Journal of Epidemiology. 7 Feb 2022.

Links:

Drug Topics (National Institute on Drug Abuse/NIH)

Opioid Overdose Crisis (NIDA)

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

Tarlise Townsend (NYU Langone, New York)

David Kline (Wake Forest University School of Medicine, Winston-Salem, NC)

NIH Support: National Institute on Drug Abuse


U.S. Surgeon General on Emotional Well-Being and Fighting the Opioid Epidemic

Posted on by Dr. Francis Collins

From September 2019 to September 2020, the Centers for Disease Control and Prevention reported nearly 90,000 overdose deaths in the United States. These latest data on the nation’s opioid crisis offer another stark reminder that help is desperately needed in communities across the land. NIH’s research efforts to address the opioid crisis have been stressed during the pandemic, but creative investigators have come up with workarounds like wider use of telemedicine to fill the gap.

Much of NIH’s work on the opioid crisis is supported by the Helping to End Addiction Long-term (HEAL) Initiative. Recently, the more-than 500 investigators supported by HEAL came together virtually for their second annual meeting to discuss the initiative’s latest research progress and challenges.

As part of the meeting, I had a conversation with Dr. Vivek Murthy, the U.S. Surgeon General. Dr. Murthy served as the 19th U.S. Surgeon General under the Obama Administration and was recently confirmed as the 21st Surgeon General under the Biden Administration. In his first term as America’s Doctor, in which I had the privilege of working with him, Dr. Murthy created initiatives to tackle our country’s most urgent public health issues, including addiction and the opioid crisis. He also issued the nation’s first Surgeon General’s Report on addiction, presenting the latest scientific data and issuing a call to action to recognize addiction as a chronic illness—and not a moral failing.

In 2016, Dr. Murthy sent a letter to 2.3 million healthcare professionals urging them to join a movement to tackle the opioid epidemic. This was the first time in the history of the office that a Surgeon General had issued a letter calling the medical profession to action on this issue. In 2017, Dr. Murthy focused his attention on chronic stress and isolation as prevalent problems with profound implications for health, productivity, and happiness.

Our conversation during the HEAL meeting took place via videoconference, with the Surgeon General connecting from Washington, D.C., and me linking in from my home in Maryland. Here’s a condensed transcript of our chat:


Collins: Welcome, Dr. Murthy. We’ve known each other for a few years, and I know that you’ve talked extensively about the national epidemic of loneliness. What have you learned about loneliness and how it affects our emotional wellbeing?

Murthy: Thanks, Francis. Loneliness and perceived social isolation are profound challenges for communities struggling with addiction, including opioid use disorders. I had no real background in these issues when I started as Surgeon General in 2014. I was educated by people I met all across the country, who in their own way would tell me their stories of isolation and loneliness. It’s a common stressor, especially for those who struggle with opioid use disorders. Stress can be a trigger for relapse. It’s also connected with overdose attempts and overdose deaths.

But loneliness is bigger than addiction. It is not just a bad feeling. Loneliness increases our risk of anxiety and depression, dementia, cardiac disease, and a host of other conditions. However you cut it, addressing social isolation and loneliness is an important public-health issue if we care about addiction, if we care about mental health—if we care about the physical wellbeing of people in our country.

Collins: Vivek, you made the diagnosis of an epidemic of American loneliness back before COVID-19 came along. With the emergence of COVID-19 a little more than a year ago, it caused us to isolate ourselves even more. Now that you’re back as Surgeon General and seeing the consequences of the worst pandemic in 103 years, is loneliness even worse now than before the pandemic?

Murthy: I think there are many people for whom that sense of isolation and loneliness has increased during the pandemic. But the pandemic has been a very heterogenous experience. There are some people who have found themselves more surrounded by their extended family or a close set of friends. That has been, in many ways, a luxury. For many people who are on the frontlines as essential workers, whose jobs don’t permit them to just pick up and leave and visit extended family, these have been very stressful and isolating times.

So, I am worried. And I’m particularly worried about young people—adolescents and young adults. They already had high rates of depression, anxiety, and suicide before the pandemic, and they’re now struggling with loneliness. I mention this because young people are so hyperconnected by technology, they seem to be on TikTok and Instagram all the time. They seem to be chatting with their friends constantly, texting all the time. How could they feel isolated or lonely?

But one of the things that has become increasingly clear is what matters when it comes to loneliness is the quality of your human connections, not the quantity. For many young people that I spoke to while traveling across the country, they would say that, yes, we’re connected to people all the time. But we don’t necessarily feel like we can always be ourselves in our social media environment. That’s where comparison culture is at its height. That’s where we feel like our lives are always falling short, whether it’s not having a fancy enough job, not having as many friends, or not having the right clothing or other accessories.

We talk a lot about resilience in our country. But how do we develop more resilient people? One of the keys is to recognize that social connections are an important source of resilience. They are our natural buffers for stress. When hard things happen in our lives, so many of us just instinctively will pick up the phone to call a friend. Or we’ll get into the car and go visit a member of our family or church. The truth is, if we want to build a society that’s healthier mentally and physically, that is more resilient, and that is also more happy and fulfilled, we have to think about how we build a society that is more centered around human connection and around relationships.

My hope is that one of the things we will reevaluate is building a people-centered society. That means designing workplaces that allow people to prioritize relationships. It means designing schools that equip our children with social and emotional learning tools to build healthy relationships from the earliest ages. It means thinking about public policy, not from just the standpoint of financial impact but in terms of how it impacts communities and how it can fracture communities.

We have an opportunity to do that now, but it won’t happen by default. We have to think through this very proactively, and it starts with our own lives. What does it mean for each of us to live a truly people-centered life? What decisions would we make differently about work, about how we spend time, about where we put our attention and energy?

Collins: Those are profound and very personal words that I think we can all relate to. Let me ask you about another vulnerable population that we care deeply about. There are 50 million Americans who are living with chronic pain, invisible to many, especially during the pandemic, for whom being even more isolated has been particularly rough—and who are perhaps in a circumstance where getting access to medical care has been challenging. As Surgeon General, are you also looking closely at the folks with chronic pain?

Murthy: You’re right, the populations that were more vulnerable pre-pandemic have really struggled during this pandemic—whether that’s getting medications for treatment, needed counseling services, or taking part in social support groups, which are an essential part of the overall treatment approach and staying in recovery. It’s a reminder of how urgent it is for us, number one, to improve access to healthcare in our country. We’ve made huge strides in this area, but millions are still out of reach of the healthcare system.

A potential silver lining of this pandemic is telemedicine, which has extraordinary potential to improve and extend access to services for people living with substance use disorders. In 2016, I remember visiting a small Alaskan fishing village that you can only get to by boat or plane. In that tiny village of 150 people, I walked into the small cabin where they had first-aid supplies and provided some basic medical care. There I saw a small monitor mounted on the wall and a chair. They told me that the monitor is where people, if they’re dealing with a substance use disorder, come and sit to get counseling services from people in the lower 48 states. I was so struck by that. To know that telemedicine could reach this remote Alaskan village was really extraordinary.

I think the pandemic has accelerated our adoption of telemedicine by perhaps five years or more. But we must sustain this momentum not only with investment in broadband infrastructure, but with other things that seem mundane, like the reimbursement structure around telemedicine. I talk to clinicians now who say they are seeing some private insurers go back on reimbursement for telemedicine because the pandemic is starting to get better. But the lesson learned is not that telemedicine should go away; it’s that we should be integrating it even more deeply into the practice of medicine.

The future of care, I believe, is bringing care closer to where people are, integrating it into their workflow, bringing it to their homes and their neighborhoods. I saw this so clearly for many of the patients I cared for who fell into that category of being in vulnerable populations. They were working two, three jobs, trying to take care of their children at the same time. Having a conversation with them about how they could find time to go to the gym was almost a laughable matter because they were literally dealing with issues of survival and putting food on the table for their kids. As a society we have to do more to understand the lives of people who fall into those categories and provide services that bring what they need to them, as opposed to expecting them to come to us.

If we continue in a purely fee-for-service-based environment where people must go multiple places to get their care, we will not ultimately get care to the vulnerable populations that have struggled the most and that are hoping that we will do better this time around. I think we can. I think we must. And I think COVID may just be, in part, the impetus to move forward in a different way that we need.

Collins: Let’s talk a minute about the specifics of the opioid crisis. If we’re going to move this crisis in the right direction, are there particular areas that you would say we really need more rigorous data in order to convince the medical care system—both the practitioners and the people deciding about reimbursement—that these are things we must do?

Murthy: There are a few areas that come to mind, and I’ve jotted them down. It is so important for us to do research with vulnerable populations, recognizing they often get left out. It’s essential that we conduct studies specifically for these populations so that we can better target interventions to them.

The second area is prevention programs. People want to prevent illnesses. I have not met anybody anywhere in the United States who has said, “I’d rather get diabetes first and treat it versus prevent it in the first place.” As silly as that might sound, it is the exact opposite of how we finance health interventions in our country. We put the lion’s share of our dollars in treatment. We do very little in prevention.

The third piece is the barriers faced by primary-care clinicians, who we want to be at the heart of providing a lot of these treatment services. I’ll tell you, just from my conversations with primary-care docs around the country, they worry about not having enough for their patients in the way of social work and social support services in their offices.
Finally, it has become extraordinarily clear to me that social support is one of the critical elements of treatment for substance use disorders. That it is what helps keep people in recovery. I think about the fact that many people I met who struggle with opioid use disorders had family members who were wondering how they could be helpful. They weren’t sure. They said, “Should I just keep badgering my relative to go to treatment? Should I take a tough love approach? What should I do to be helpful?”

This actually is one of the most pressing issues: social support is most often going to come from family, from friends, and from other community members. So, being able to guide them in an evidence-based way about what measures, what forms actually can be helpful to people struggling with opioid use disorders could also be immensely helpful to a group that is looking to provide assistance and support, but often is struggling to figure out how best to do that.

Collins: Vivek, you were focused as Surgeon General in the Obama Administration on the importance of changing how America thinks about addiction—that it is not a moral failing but a chronic illness that has to be treated with compassion, urgency, skill, and medical intervention. Are we getting anywhere with making that case?

Murthy: Sometimes people shy away from addressing the stigma around addiction because it feels too hard to address. But it is one of the most important issues to address. If people are still feeling judged for their disorders, they are not going to feel comfortable coming forward and getting treatment. And others will hesitate to step up and provide support.

I will always remember the young couple I met in Oklahoma who had lost their son to an opioid overdose. They told me that previously in their life whenever they had a struggle—a job loss or other health issue in the family—neighbors would come over, they would drop off food, they would visit and sit with them in their living room and hold their hands to see if they were okay. When their son died after opioid use disorder, it was silent. Nobody came over. It’s a very common story of how people feel ashamed, they feel uncomfortable, they don’t know quite what to say. So they stay away, which is the worst thing possible during these times of great pain and distress.

I do think we have made progress in the last few years. There are more people stepping forward to tell their stories. There are more people and practitioners who are embracing the importance of talking to their patients about substance use disorders and getting involved in treating them. But the truth is, we still have many people in the country who feel ashamed of what they’re dealing with. We still have many family members who feel that this is a source of shame to have a loved one struggling with a substance use disorder.

To me, this is much bigger than substance use disorders. This is a broader cultural issue of how we think about strength and vulnerability. We have defined strength in modern society as the loudest voice in the room or the person with the most physical prowess, the person who’s aggressive in negotiations, and the person who’s famous.
But I don’t think that’s what strength really is. Strength is so often displayed in moments of vulnerability when people have the courage to open up and be themselves. Strength is defined by the people who have the courage to display love, patience, and compassion, especially when it’s difficult. That’s what real strength is.

One of my hopes is that, as a society, we can ultimately redefine strength. As we think about our children and what we want them to be, we cannot aspire for them to be the loudest voice in the room. We can aspire for them to be the most-thoughtful, the most-welcoming, the most-inviting, the most-compassionate voice in the room.

If we truly want to be a society that’s grounded in love, compassion, and kindness, if we truly recognize those as the sources of strength and healing, we have to value those in our workplaces. They have to be reflected in our promotion systems. We have to value them in the classroom. Ultimately, we’ve got to build our lives around them.

That is a broader lesson that I took from all of the conversations I’ve had with people who struggle with opioid use disorders. What I took was, yes, we need medication and assisted treatment; yes, we need counseling services; yes, we need social services and wraparound services and recovery services. But the engine that will drive our healing is fundamentally the love and compassion that come from human relationships.

We all have the ability to heal because we all have the ability to be kind and to love one another. That’s the lesson that it took me more than two decades to learn in medicine. More important than any prescription that I could write is the compassion that I could extend to patients simply by listening, by showing up, by being present in their lives. We all have that ability, regardless of what degrees follow our name.

Collins: Vivek, this has been a wonderful conversation. We are fortunate to have you as our Surgeon General at this time, when we need lots of love and compassion.

Murthy: Thank you so much, Francis.


Links:

Opioids (National Institute on Drug Abuse/NIH)

Opioid Overdose Crisis (NIDA)

Vice Admiral Vivek H. Murthy (U.S. Department of Health and Human Services, Washington, D.C.)

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

Video: Emotional Well Being and the Power of Connections to Fight the Opioid Epidemic (HEAL/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)


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


After Opioid Overdose, Most Young People Aren’t Getting Addiction Treatment

Posted on by Dr. Francis Collins

Teenager's support
Credit: iStock/KatarzynaBialasiewicz

Drug overdoses continue to take far too many lives, driven primarily by the opioid crisis (though other drugs, such as methamphetamine and cocaine, are also major concerns). While NIH’s Helping to End Addiction Long-term (HEAL) Initiative is taking steps to address this terrible crisis, new findings serve as another wake-up call that young people battling opioid addiction need a lot more assistance to get back on the right track.

In a study of more than 3,600 individuals, aged 13-22, who survived an opioid overdose, an NIH-funded team found that only about one-third received any kind of follow-up addiction treatment [1]. Even more troubling, less than 2 percent of these young people received the gold standard approach of medication treatment.

The findings reported in JAMA Pediatrics come from Rachel Alinsky, an adolescent medicine and addiction medicine fellow at Johns Hopkins Children’s Center, Baltimore. She saw first-hand the devastating toll that opioids are taking on our youth.

Alinsky also knew that nationally more than 4,000 fatal opioid overdoses occurred in people between the ages of 15 and 24 in 2016 [2]. Likewise, rates of nonfatal opioid overdoses for teens and young adults also have been escalating, leading to more than 7,000 hospitalizations and about 28,000 emergency department visits in 2015 alone [3].

In the latest study, Alinsky wanted to find out whether young people who overdose receive timely treatment to help prevent another life-threatening emergency. According to our best evidence-based guidelines, timely treatment for youth with an opioid addiction should include medication, ideally along with behavioral interventions.

That’s because opioid addiction rewires the brain—will power alone is simply not sufficient to achieve and sustain recovery. After one overdose, the risk of dying from another one rises dramatically. So, it is critical to get those who survived an overdose into effective treatment right away.

Alinsky and her team dove into the best-available dataset, consisting of data on more than 4 million mostly low-income adolescents and young adults who’d been enrolled in Medicaid for at least six months in 16 states. The sample included 3,606 individuals who’d been seen by a doctor and diagnosed with opioid poisoning. A little over half of them were female; most were non-Hispanic whites.

Heroin accounted for about a quarter of those overdoses. The rest involved other opioids, most often prescription painkillers. However, the researchers note that some overdoses attributed to heroin might have been caused by the powerful synthetic opioid fentanyl. The use of fentanyl, often mixed with heroin, was on the rise in the study’s final years, but it was rarely included in drug tests at the time.

Less than 20 percent of young people in the sample received a diagnosis of opioid use disorder, or a problematic pattern of opioid use resulting in impairment or distress. What’s more, in the month following an overdose, few received the current standard for addiction treatment, which should include behavioral therapy and treatment with one of three drugs: buprenorphine, naltrexone, or methadone.

Drilling a little deeper into the study’s findings:

• 68.9 percent did not receive addiction treatment of any kind.
• 29.3 percent received behavioral health services alone.
• Only 1.9 percent received one of three approved medications for opioid use disorder.

It’s been estimated previously that teens and young adults are one-tenth as likely as adults 25 years and older to get the recommended treatment for opioid use disorder [4]. How can that be? The researchers suggest that one factor might be inexperience among pediatricians in diagnosing and treating opioid addiction. They also note that, even when the problem is recognized, doctors sometimes struggle to take the next step and connect young people with addiction treatment facilities that are equipped to provide the needed treatment to adolescents.

As this new study shows, interventions designed to link teens and young adults with the needed recovery treatment and care are desperately needed. As we continue to move forward in tackling this terrible crisis through the NIH’s HEAL Initiative and other efforts, finding ways to overcome such systemic barriers and best engage our youth in treatment, including medication, will be essential.

References:

[1] Receipt of addiction treatment after opioid overdose among Medicaid-enrolled adolescents and young adults. Alinsky RH, Zima BT, Rodean J, Matson PA, Larochelle MR, Adger H Jr, Bagley SM, Hadland SE. JAMA Pediatr. 2020 Jan 6:e195183.

[2] Overdose death rates. National Institute on Drug Abuse, NIH.

[3] 2018 annual surveillance drug-related risks and outcomes—United States: surveillance special report. Centers for Disease Control and Prevention.

[4] Medication-assisted treatment for adolescents in specialty treatment for opioid use disorder. Feder KA, Krawczyk N, Saloner B. J Adolesc Health. 2017 Jun;60(6):747-750.

Links:

Opioid Overdose Crisis (National Institute on Drug Abuse/NIH)

Opioid Overdose (Centers for Disease Control and Prevention, Atlanta)

Decisions in Recovery: Treatment for Opioid Use Disorder (Substance Abuse and Mental Health Services Administration, Rockville, MD)

Rachel Alinsky (Johns Hopkins University Children’s Center, Baltimore)

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

NIH Support: Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Institute on Drug Abuse


Easier Access to Naloxone Linked to Fewer Opioid Deaths

Posted on by Dr. Francis Collins

Doors opening to make Naloxone available
Credit: HHS

A few weeks ago, I was pleased to take part in the announcement of NIH’s HEALing Communities Study in four states hard hit by the opioid epidemic. This study will test a comprehensive, evidence-based approach—which includes the wide distribution of naloxone to reverse overdoses—with the aim of reducing opioid-related deaths in selected communities by 40 percent over three years.

That’s a very ambitious goal. So, I was encouraged to read about new findings that indicate such reductions may be within our reach if society implements a number of key changes. Among those is the need to arm friends, family members, and others with the ability to save lives from opioid overdoses. Between 2013 and 2016, nine states instituted laws that give pharmacists direct authority to dispense naloxone to anyone without a prescription. However, the impact of such changes has remained rather unclear. Now, an NIH-funded analysis has found that within a couple of years of these new laws taking effect, fatal opioid overdoses in these states fell significantly [1].

The misuse and overuse of opioids, which include heroin, fentanyl, and prescription painkillers, poses an unprecedented public health crisis. Every day, more than 130 people in the United States die from opioid overdoses [2]. Not only are far too many families losing their loved ones, this crisis is costing our nation tens of billions of dollars a year in lost productivity and added expenses for healthcare, addiction treatment, and criminal justice.

Opioid overdoses lead to respiratory arrest. If not reversed in a few minutes, this will be fatal. In an effort to address this crisis, the federal government and many states have pursued various strategies to increase access to naloxone, which is a medication that can quickly restore breathing in a person overdosing on opioids. Naloxone, which can be delivered via nasal spray or injection, works by binding opioid receptors to reverse or block the effect of opioids. The challenge is to get naloxone to those who need it before it’s too late.

In some states, a physician still must prescribe naloxone. In others, naloxone access laws (NALs) have given pharmacists the authority to supply naloxone without a doctor’s orders. But not all NALs are the same.

Some NALs, including those in Alaska, California, Connecticut, Idaho, New Mexico, North Dakota, Oklahoma, Oregon, and South Carolina, give pharmacists direct authority to dispense naloxone to anyone who requests it. But NALs in certain other states only give pharmacists indirect authority to dispense naloxone to people enrolled in certain treatment programs, or who meet other specific criteria.

In the new analysis, published in JAMA Internal Medicine, a team that included Rahi Abouk, William Paterson University, Wayne, NJ, and Rosalie Liccardo Pacula and David Powell, RAND Corp., Arlington, VA, asked: Do state laws to improve naloxone access lead to reductions in fatal overdoses involving opioids? The answer appears to be “yes,” but success seems to hinge on the details of those laws.

The evidence shows that states allowing pharmacists direct authority to dispense naloxone to anyone have seen large increases in the dispensing of the medication. In contrast, states granting pharmacists’ only indirect authority to dispense naloxone have experienced little change.

Most importantly, the research team found that states that adopted direct authority NALs experienced far greater reductions in opioid-related deaths than states with indirect authority NALs or no NALs. Specifically, the analysis showed that in the year after direct authority NALs were enacted, fatal opioid overdoses in those states fell an average of 27 percent, with even steeper declines in ensuing years. Longer-term data are needed, and, as in all observational studies of this sort, one must be careful not to equate correlation with causation. But these findings are certainly encouraging.

There were some other intriguing trends. For instance, the researchers found that states that allow pharmacists to dispense naloxone without a prescription also saw an increase in the number of patients treated at emergency departments for nonfatal overdoses. This finding highlights the importance of combining strategies to improve naloxone access with other proven interventions and access to medications aimed to treat opioid addiction. Integration of all possible interventions is exactly the goal of the HEALing Communities Study mentioned above.

Successfully tackling the opioid epidemic will require a multi-pronged approach, including concerted efforts and research advances in overdose reversal, addiction treatment, and non-addictive pain management . As I’ve noted before, we cannot solve the opioid addiction and overdose crisis without finding innovative new ways to treat pain. The NIH is partnering with pharmaceutical industry leaders to accelerate this process, but it will take time. The good news based on this new study is that, with thoughtful strategies and policies in place, many of the tools needed to help address this epidemic and save lives may already be at our disposal.

References:

[1] Association Between State Laws Facilitating Pharmacy Distribution of Naloxone and Risk of Fatal Overdose. Abouk R, Pacula RL, Powell D. JAMA Intern Med. 2019 May 6

[2] Opioid Overdose Crisis. National Institute on Drug Abuse/NIH. Updated January 2019.

Links:

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

Naloxone for Opioid Overdose (National Institute on Drug Abuse/NIH)

NIH Support: National Institute on Drug Abuse


Researchers Elucidate Role of Stress Gene in Chronic Pain

Posted on by Dr. Francis Collins

Credit: Getty Images/simonkr

For most people, pain eventually fades away as an injury heals. But for others, the pain persists beyond the initial healing and becomes chronic, hanging on for weeks, months, or even years. Now, we may have uncovered an answer to help explain why: subtle differences in a gene that controls how the body responds to stress.

In a recent study of more than 1,600 people injured in traffic accidents, researchers discovered that individuals with a certain variant in a stress-controlling gene, called FKBP5, were more likely to develop chronic pain than those with other variants [1]. These findings may point to new non-addictive strategies for preventing or controlling chronic pain, and underscore the importance of NIH-funded research for tackling our nation’s opioid overuse crisis.


Fireside Chat with U. S. Surgeon General

Posted on by Dr. Francis Collins

Francis Collins and Surgeon General Adams

I sat down with U. S. Surgeon General Dr. Jerome Adams for a fireside chat about chronic pain management, the Helping to End Addiction Long-Term (HEAL) Initiative, and the opioid crisis. The event was held as part of the 13th Annual NIH Pain Consortium Symposium.
Credit: Andrew Propp