telehealth
Suicide Prevention Research in a Rapidly Changing World
Posted on by Joshua A. Gordon, M.D., Ph.D., National Institute of Mental Health
As I sit down to write this blog, the COVID-19 pandemic continues to have a widespread impact, and we’re all trying to figure out our “new normal.” For some, figuring out the new normal has been especially difficult, and that’s something for all of us to consider during September, which is National Suicide Prevention Awareness Month. It’s such an important time to share what we know about suicide prevention and consider how we can further this knowledge to those in need.
At NIH’s National Institute of Mental Health (NIMH), we’ve been asking ourselves: What have we learned about suicide risk and prevention during the pandemic? And how should our research evolve to reflect a rapidly changing world?
Addressing Disparities
Over the last few years, people have been concerned about the pandemic’s impact on suicide rates. So far, data suggest that the overall suicide rate in the U.S. has remained steady. But there is concerning evidence that the pandemic has disproportionately affected suicide risk in historically underserved communities.
For example, data suggest that people in minority racial and ethnic groups experienced greater increases in suicidal thoughts during the pandemic [1]. Additional data indicate that suicide rates may be rising among some young adult racial and ethnic minority groups [2].
Structural racism and other social and environmental factors are major drivers of mental health disparities, and NIMH continues to invest in research to understand how these social determinants of health influence suicide risk. This research includes investigations into the effects of long-term and daily discrimination.
To mitigate these effects, it is critical that we identify specific underlying mechanisms so that we can develop targeted interventions. To this end, NIMH is supporting research in underserved communities to identify suicide risk and the protective factors and effective strategies for reducing this risk (e.g., RFA-MH-22-140, RFA-MH-21-188, RFA-MH-21-187). There are important lessons to be learned that we can’t afford to miss.
Building Solid Foundations
The pandemic also underscored the urgent need to support youth mental health. Indeed, in December 2021, U.S. Surgeon General Dr. Vivek Murthy issued the Advisory on Protecting Youth Mental Health, calling attention to increasing rates of depression and suicidal behaviors among young people. Crucially, the advisory highlighted the need to “recognize that mental health is an essential part of overall health.”
At NIMH, we know that establishing a foundation for good mental health early on can support a person’s overall health and well-being over a lifetime. In light of this, we are investing in research to identify effective prevention efforts that can help set kids on positive mental health trajectories early in life.
Additionally, by re-analyzing research investments already made, we are looking to see whether these early prevention efforts have meaningful impacts on later suicide risk and mental health outcomes. These findings may help to improve a range of systems—such as schools, social services, and health care—to better support kids’ mental health needs.
Improving and Expanding Access
The pandemic has also shown us that telehealth can be an effective means of delivering and increasing access to mental health care. The NIMH has supported research examining telehealth as a tool for improving suicide prevention services, including the use of digital tools that can help extend provider reach and support individuals at risk for suicide.
At the same time, NIMH is investing in work to understand the most effective ways to help providers use evidence-based approaches to prevent suicide. This research helps inform federal partners and others about the best ways to support policies and practices that help prevent suicide deaths.
In July, the Substance Abuse and Mental Health Services Administration (SAMHSA) launched the 988 Suicide & Crisis Lifeline, a three-digit suicide prevention and mental health crisis number. This service builds on the existing National Suicide Prevention Lifeline, allowing anyone to call or text 988 to connect with trained counselors and mental health services. Research supported by NIMH helped build the case for such lifelines, and now we’re calling for research aimed at identifying the best ways to help people use this evolving crisis support system.
Looking Ahead
With these and many other efforts, we are hopeful that people who are at risk for suicidal thoughts and behaviors will be able to access the evidence-based support and services they need. This National Suicide Prevention Awareness Month, I’d like to issue a call to action: Help raise awareness by sharing resources on how to recognize the warning signs for suicide and how to get help. By working together, we can prevent suicide and save lives.
References:
[1] Racial and ethnic disparities in the prevalence of stress and worry, mental health conditions, and increased substance use among adults during the COVID-19 pandemic – United States, April and May 2020. McKnight-Eily LR, Okoro CA, Strine TW, Verlenden J, Hollis ND, Njai R, Mitchell EW, Board A, Puddy R, Thomas C. MMWR Morb Mortal Wkly Rep. 2021 Feb 5;70(5):162-166.
[2] One Year In: COVID-19 and Mental Health. National Institute of Mental Health Director’s Message. April 9, 2021.
Links:
988 Suicide & Crisis Lifeline (Substance Abuse and Mental Health Services Administration, Rockville, MD)
Substance Abuse and Mental Health Services Administration Treatment Locator (SAMHSA)
Help for Mental Illnesses (National Institute of Mental Health/NIH)
Suicide Prevention (NIMH)
Digital Shareables on Suicide Prevention (NIMH)
Digital Shareables on Coping with COVID-19 (NIMH)
NIMH Director’s Messages about COVID-19 (NIMH)
NIMH Director’s Messages about Suicide (NIMH)
Note: Dr. Lawrence Tabak, who performs the duties of the NIH Director, has asked the heads of NIH’s Institutes and Centers (ICs) to contribute occasional guest posts to the blog to highlight some of the interesting science that they support and conduct. This is the 16th in the series of NIH IC guest posts that will run until a new permanent NIH director is in place.
Using Science To Solve Oral Health Inequities
Posted on by Rena D'Souza, D.D.S., M.S., Ph.D., National Institute of Dental and Craniofacial Research
At NIH, we have a front row seat to remarkable advances in science and technology that help Americans live longer, healthier lives. By studying the role that the mouth and saliva can play in the transmission and prevention of disease, the National Institute of Dental and Craniofacial Research (NIDCR) contributed to our understanding of infectious agents like the coronavirus SARS-CoV-2, the cause of COVID-19. While these and other NIH-supported advances undoubtedly can improve our nation’s health as a whole, not everyone enjoys the benefits equally—or at all. As a result, people’s health, including their oral health, suffers.
That’s a major takeaway from Oral Health in America: Advances and Challenges, a report that NIDCR recently released on the status of the nation’s oral health over the last 20 years. The report shows that oral health has improved in some ways, but people from marginalized groups —such as those experiencing poverty, people from racial and ethnic minority groups, the frail elderly, and immigrants—shoulder an unequal burden of oral disease.
At NIDCR, we are taking the lessons learned from the Oral Health in America report and using them to inform our research. It will help us to discover ways to eliminate these oral health differences, or disparities, so that everyone can enjoy the benefits of good oral health.
Why does oral health matter? It is essential for our overall health, well-being, and productivity. Untreated oral diseases, such as tooth decay and gum disease, can cause infections, pain, and tooth loss, which affect the ability to chew, swallow, eat a balanced diet, speak, smile, and go to school and work.
Treatments to fix these problems are expensive, so people of low socioeconomic means are less likely to receive quality care in a timely manner. Importantly, untreated gum disease is associated with serous systemic conditions such as diabetes, heart disease, and Alzheimer’s disease.
A person experiencing poverty also may be at increased risk for mental illness. That, in turn, can make it hard to practice oral hygiene, such as toothbrushing and flossing, or to maintain a relationship with a dental provider. Mental illnesses and substance use disorders often go hand-in-hand, and overuse of opioids, alcohol, and tobacco products also can raise the risk for tooth decay, gum disease, and oral cancers. Untreated dental diseases in this setting can cause pain, sometimes leading to increased substance use as a means of self-medication.
Research to understand better the connections between mental health, addiction, and oral health, particularly as they relate to health disparities, can help us develop more effective ways to treat patients. It also will help us prepare health providers, including dentists, to deliver the right kind of care to patients.
Another area that is ripe for investigation is to find ways to make it easier for people to get dental care, especially those from marginalized or rural communities. For example, the COVID-19 pandemic spurred more dentists to use teledentistry, where practitioners meet with patients remotely as a way to provide certain aspects of care, such as consultations, oral health screenings, treatment planning, and education.
Teledentistry holds promise as a cost-saving approach to connect dentists to people living in regions that may have a shortage of dentists. Some evidence suggests that providing access to oral health care outside of dental clinics—such as in schools, primary care offices, and community centers—has helped reduce oral health disparities in children. We need additional research to find out if this type of approach also might reduce disparities in adults.
These are just some of the opportunities highlighted in the Oral Health in America report that will inform NIDCR’s research in the coming years. Just as science, innovation, and new technologies have helped solve some of the most challenging health problems of our time, so too can they lead us to solutions for tackling oral health disparities. Our job will not be done until we can improve oral and overall health for everyone across America.
Links:
Oral Health in America: Advances and Challenges (National Institute of Dental and Craniofacial Research/NIH)
Oral Health in America Editors Issue Guidance for Improving Oral Health for All (NIDCR)
NIH, HHS Leaders Call for Research and Policy Changes To Address Oral Health Inequities (NIDCR)
NIH/NIDCR Releases Oral Health in America: Advances and Challenges (NIDCR)
Note: Acting NIH Director Lawrence Tabak has asked the heads of NIH’s Institutes and Centers (ICs) to contribute occasional guest posts to the blog to highlight some of the interesting science that they support and conduct. This is the 11th in the series of NIH IC guest posts that will run until a new permanent NIH director is in place.
Research to Address the Real-Life Challenges of Opioid Crisis
Posted on by Lawrence Tabak, D.D.S., Ph.D.
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)
RADx Initiative: Bioengineering for COVID-19 at Unprecedented Speed and Scale
Posted on by Bruce J. Tromberg, Ph.D., National Institute of Biomedical Imaging and Bioengineering
As COVID-19 rapidly expanded throughout the world in April 2020, many in the biomedical technology community voiced significant concerns about the lack of available diagnostic tests. At that time, testing for SARS-CoV-2, the coronavirus that causes COVID-19, was conducted exclusively in clinical laboratories by order of a health-care provider. “Over the counter” (OTC) tests did not exist, and low complexity point of care (POC) platforms were rare. Fewer than 8 million tests were performed in the U.S. that month, and it was clear that we needed a radical transformation to make tests faster and more accessible.
By February 2022, driven by the Omicron variant surge, U.S. capacity had increased to a new record of more than 1.2 billion tests in a single month. Remarkably, the overwhelming majority of these—more than 85 percent—were “rapid tests” conducted in home and POC settings.
The story behind this practice-changing, “test-at-home” transformation is deeply rooted in technologic and manufacturing innovation. The NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB), working collaboratively with multiple partners across NIH, government, academia, and the private sector, has been privileged to play a leading role in this effort via the Rapid Acceleration of Diagnostics (RADx®) initiative. On this two-year anniversary of RADx, we take a brief look back at its formation, impact, and potential for future growth.
On April 24, 2020, Congress recognized that testing was an urgent national need and appropriated $1.5 billion to NIH via an emergency supplement [1]. The goal was to substantially increase the number, type, and availability of diagnostic tests in only five to six months. Since the “normal” commercialization cycle for this type of diagnostic technology is typically more than five years, we needed an entirely new approach . . . fast.
The RADx initiative was launched just five days after that challenging Congressional directive [2]. Four NIH RADx programs were eventually created to support technology development and delivery, with the goal of matching test performance with community needs [3].The first two programs, RADx Tech and RADx Advanced Technology Platforms (ATP), were developed by NIBIB and focused on innovation for rapidly creating, scaling up, and deploying new technologies.
RADx Tech is built around NIBIB’s Point of Care Technologies Research Network (POCTRN) and includes core activities for technology review, test validation, clinical studies, regulatory authorization, and test deployment. Overall, the RADx Tech network includes approximately 900 participants from government, academia, and the private sector with unique capabilities and resources designed to decrease inherent risk and guide technologies from design and development to fully disseminated commercial products.
At the core of RADx Tech operations is the “innovation funnel” rapid review process, popularized as a shark tank [4]. A total of 824 complete applications were submitted during two open calls in a four-month period, beginning April 2020 and during a one-month period in June 2021. Forty-seven projects received phase 1 funding to validate and lower the inherent risk of developing these technologies. Meanwhile, 50 companies received phase 2 contracts to support FDA authorization studies and manufacturing expansion [5]
Beyond test development, RADx Tech has evolved to become a key contributor to the U.S. COVID-19 response. The RADx Independent Test Assessment Program (ITAP) was launched in October 2021 to accelerate regulatory authorization of new tests as a joint effort with the Food and Drug Administration (FDA) [6]. The ITAP acquires analytical and clinical performance data and works closely with FDA and manufacturers to shave weeks to months off the time it normally takes to receive Emergency Use Authorization (EUA).
The RADx Tech program also created a Variant Task Force to monitor the performance of tests against each new coronavirus “variant of concern” that emerges. This helps to ensure that marketed tests continue to remain effective. Other innovative RADx Tech projects include Say Yes! Covid Test, the first online free OTC test distribution program, and Project Rosa, which conducts real-time variant tracking across the country [7].
RADx Tech, by any measure, has exceeded even the most-optimistic expectations. In two years, RADx Tech-supported companies have received 44 EUAs and added approximately 2 billion tests and test products to the U.S. capacity. These remarkable numbers have steadily increased from more than16 million tests in September 2020, just five months after the program was established [8].
RADx Tech has also made significant contributions to the distribution of 1 billion free OTC tests via the government site, COVID.gov/tests. It has also provided critical guidance on serial testing and variants that have improved test performance and changed regulatory practice [9,10]. In addition, the RADx Mobile Application Reporting System (RADx MARS) reduces barriers to test reporting and test-to-treat strategies’ The latter offers immediate treatment options via telehealth or a POC location whenever a positive test result is reported. Finally, the When to Test website provides critical guidance on when and how to test for individuals, groups, and communities.
As we look to the future, RADx Tech has enormous potential to impact the U.S. response to other pathogens, diseases, and future pandemics. Major challenges going forward include improving home tests to work as well as lab platforms and building digital health networks for capturing and reporting test results to public health officials [11].
A recent editorial published in the journal Nature Biotechnology noted, “RADx has spawned a phalanx of diagnostic products to market in just 12 months. Its long-term impact on point of care, at-home, and population testing may be even more profound [12].” We are now poised to advance a new wave of precision medicine that’s led by innovative diagnostic technologies. It represents a unique opportunity to emerge stronger from the pandemic and achieve long-term impact.
References:
[1] Public Law 116 -139—Paycheck Protection Program and Health Care Enhancement Act.
[2] NIH mobilizes national innovation initiative for COVID-19 diagnostics, NIH news release, April 29, 2020.
[3] Rapid scaling up of Covid-19 diagnostic testing in the United States—The NIH RADx Initiative. Tromberg BJ, Schwetz TA, Pérez-Stable EJ, Hodes RJ, Woychik RP, Bright RA, Fleurence RL, Collins FS. N Engl J Med. 2020 Sep 10;383(11):1071-1077.
[4] We need more covid-19 tests. We propose a ‘shark tank’ to get us there. Alexander L. and Blunt R., Washington Post, April 20, 2020.
[5] RADx® Tech/ATP dashboard, National Institute of Biomedical Imaging and Bioengineering, NIH.
[6] New HHS actions add to Biden Administration efforts to increase access to easy-to-use over-the-counter COVID-19 tests. U.S. Department of Health and Human Services Press Office, October 25, 2021.
[7] A method for variant agnostic detection of SARS-CoV-2, rapid monitoring of circulating variants, detection of mutations of biological significance, and early detection of emergent variants such as Omicron. Lai E, et al. medRxiV preprint, January 9, 2022.
[9] Longitudinal assessment of diagnostic test performance over the course of acute SARS-CoV-2 infection. Smith RL, et al. J Infect Dis. 2021 Sep 17;224(6):976-982.
[10] Comparison of rapid antigen tests’ performance between Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) variants of SARS-CoV-2: Secondary analysis from a serial home self-testing study. Soni A, et al. MedRxiv preprint, March 2, 2022.
[11] Reporting COVID-19 self-test results: The next frontier. Health Affairs, Juluru K., et al. Health Affairs, February 11, 2022.
[12] Radical solutions. Nat Biotechnol. 2021 Apr;39(4):391.
Links:
Get Free At-Home COVID Tests (COVID.gov)
When to Test (Consortia for Improving Medicine with Innovation & Technology, Boston)
RADx Programs (NIH)
RADx® Tech and ATP Programs (National Institute of Biomedical Imaging and Biomedical Engineering/NIH)
Independent Test Assessment Program (NIBIB)
Mobile Application Reporting through Standards (NIBIB)
Point-of-Care Technologies Research Network (POCTRN) (NIBIB)
[Note: Acting NIH Director Lawrence Tabak has asked the heads of NIH’s Institutes and Centers (ICs) to contribute occasional guest posts to the blog to highlight some of the interesting science that they support and conduct. This is the eighth in the series of NIH IC guest posts that will run until a new permanent NIH director is in place.]
Addressing the Twin Challenges of Substance Use Disorders and COVID-19
Posted on by Dr. Francis Collins
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)
