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10 Years of Protecting Public Health Through Tobacco Regulatory Research

Posted on by David M. Murray, Ph.D., NIH Office of Disease Prevention

A group of happy, diverse young people waking in a city
Credit: iStock/jacoblund

Kids are flocking to flavored, disposable e-cigarettes, study finds” – The Washington Post

New ‘candy’ e-cigs catch fire after U.S. regulators stamp out Juul’s flavors” – Reuters

Headlines like these highlight a real challenge for people who want to protect kids from the harms of using tobacco products. While flavors, such as mint, menthol, watermelon, and apple pie are safe to consume in food products, inhaling them in tobacco products can be harmful and put the health of our kids at risk.+

A special kind of research is needed to help public health authorities keep up with the latest changes and trends in tobacco products. That includes studying how these flavored tobacco products are attractively marketed to children and how quickly many started using them.

In 2013, NIH and the Food and Drug Administration (FDA) launched a unique interagency partnership called the Tobacco Regulatory Science Program (TRSP), directed by Helen Meissner. It aims to reduce the public health impact of tobacco product use across the country. The NIH administers the research program through the Office of Disease Prevention (ODP), which I lead, to help inform FDA’s tobacco regulatory priorities.

This unique partnership also represents a new field of study called tobacco regulatory research. It informs proposed regulations for tobacco products based on strong scientific evidence. The TRSP brings together scientists from diverse fields, such as epidemiology, chemistry, toxicology, addiction, and psychology, to shed light on why people try and continue to use tobacco, how tobacco use affects health, and which policies might help reduce the risk of harm.

Now celebrating its 10th anniversary, this extremely productive partnership has resulted in more than 400 research grants, all peer-reviewed and designed to increase our understanding of existing and emerging tobacco products and their associated health risks.

Our research includes studies showing that menthol in cigarettes makes it easier to start smoking by reducing the harshness of tobacco [1]. People who smoke menthol cigarettes also show more signs of nicotine dependence and, therefore, are less likely to successfully quit. The research shows this is because menthol interacts with nicotine in the brain, making nicotine even more addictive.

Additionally, researchers have explored how marketing and promotion of menthol and flavored tobacco products have targeted Black and LGBTQ+ people, socioeconomically disadvantaged populations, and people with mental health challenges. These studies show that this direct marketing has contributed to the burden of tobacco-related disease among these groups and widened health inequities [2].

The TRSP also has a real-world impact on shaping tobacco policy. In April 2022, the program’s sponsored research was cited in FDA-proposed rules to prohibit menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (other than tobacco) in cigars [3]. These tobacco product standards will have a huge impact on public health by reducing youth experimentation with products like cigarettes, cigars, and cigarillos and increasing the number of people who quit smoking.

Many jurisdictions have already banned flavored tobacco products. Through our partnership with the FDA, TRSP-funded researchers have started evaluating the impact of these policies on tobacco use and public health. The need for research continues as we seek to understand how new tobacco products affect people’s use, attitudes, and health.

However, tobacco products that have the potential to addict a new generation to nicotine continue to be marketed. For example, new products that use “ice-hybrid” flavors which combine cooling and fruity/sweet properties, such as raspberry ice, are being used more often than either fruity/sweet or menthol/mint among young adult e-cigarette users [4]. Illegally marketed, but novel, flavored oral nicotine products, such as gummies and pouches, also are gaining appeal among young people. The dynamic nature of the tobacco market emphasizes the importance of TRSP to support research on tobacco products, directly informing tobacco regulation.

The success of TRSP over the past 10 years demonstrates how establishing a research pipeline that directly informs regulation can lead to effective, evidence-based health policies. The high output of research on the effects of new and emerging tobacco products, such as the appeal and addictiveness of flavored e-cigarettes, provides FDA with data to inform regulatory actions. This partnership is truly helping regulators and policymakers turn scientific discovery into actions designed to protect public health.

References:

[1] Use of menthol cigarettes, smoking frequency, and nicotine dependence among US youth. Leas EC, Benmarhnia T, Strong DR, Pierce JP. JAMA Netw Open. 2022 Jun 1;5(6):e2217144.

[2] Menthol smoking and related health disparities. Centers for Disease Control and Prevention, June 27, 2022.

[3] FDA proposes rules prohibiting menthol cigarettes and flavored cigars to prevent youth initiation, significantly reduce tobacco-related disease and death. FDA News Release, April 28, 2022.

[4] ‘Ice’ flavoured e-cigarette use among young adults. Leventhal A, Dai H, Barrington-Trimis J, Sussman S. Tob Control. 2023 Jan;32(1):114-117.

Links:

Smokefree.gov (U.S. Department of Health and Human Services, Washington, D.C.)

Office of Disease Prevention (NIH)

Tobacco Regulatory Science Program (ODP)

Director’s Messages (ODP)

Note: Dr. Lawrence Tabak, who performs the duties of the NIH Director, has asked the heads of NIH’s Institutes, Centers, and Offices to contribute occasional guest posts to the blog to highlight some of the interesting science that they support and conduct. This is the 29th in the series of NIH guest posts that will run until a new permanent NIH director is in place.


NIH Collaboration Seeks to Help Understand U.S. Burden of Health Disparities: Why Your County Matters

Posted on by Eliseo J. Pérez-Stable, M.D., National Institute on Minority Health and Health Disparities

map of U.S. and territories filled with overlapping silhouettes of different people
Credit: Edgar B. Dews III, National Institute on Minority Health and Health Disparities, NIH

Since the early 1990s, federal support of research has increased to understand minority health and identify and address health disparities. Research in these areas has evolved from a starting point of developing a basic descriptive understanding of health disparities and who is most affected. Now, it is discovering the underlying complexity of factors involved in health outcomes to inform interventions and reduce these disparities.

One of these many factors is where we live, learn, work, and play and how that affects different people. A group of NIH scientists and their colleagues recently published a study in the journal The Lancet that they hope is a step toward better understanding geographic disparities and their role in health equity [1].

Differences in Life Expectancy by County, Race, and Ethnicity, 2000-2019
Caption: Bottom acronyms are American Indian and Alaska Native (AIAN) and Asian Pacific Islander (API). Credit: GBD US Health Disparities

As Director of NIH’s National Institute on Minority Health and Health Disparities (NIMHD), I worked with NIMHD’s Scientific Director, Anna María Nápoles, to conceive the study and establish the Global Burden of Disease (GBD) U.S. Health Disparities Collaborators at NIH with five NIH Institutes and two Offices. Through this collaboration, NIH funded the Institute for Health Metrics and Evaluation (IHME), University of Washington to conduct the analysis. The IHME has worked for 30 years on the GBD project in over 200 countries.

The Lancet paper offered the first comprehensive U.S. county-level life expectancy estimates to highlight the significant gaps that persist among racial and ethnic populations across the nation. The analysis revealed that despite overall life expectancy gains of 2.3 years from 2000–2019, Black populations experienced shorter life expectancy than White populations.

In addition, American Indian and Alaska Native populations’ life expectancy did not improve and, in fact, decreased in most counties. We found national-level life expectancy advantages for Hispanic/Latino and Asian populations ranging from three to seven years, respectively, compared to White populations. But there were notable exceptions for Hispanic/Latino populations in selected counties in the Southwest.

Certainly the most-alarming trend identified in the paper was that during the study’s last 10 years (2010–2019), life expectancy growth was stagnant across all races and ethnicities. Moreover, 60 percent of U.S. counties experienced a decrease in life expectancy.

While these findings provide an important frame for how disparities exist along many dimensions—by race, ethnicity, and geographic region—they also highlight these differences within our local communities. This level of detail offers an unprecedented opportunity for researchers and public health leaders to focus on where these differences are the most prominent, and possibly give us a clearer picture on what can be done about it.

These data raise many important questions, too. What can we learn from places that are doing well in caring for their most disadvantaged populations? How can these factors be sustained, replicated, and transferred to other places? Are there current policies and/or community services that contribute to or inhibit gaining access to appropriate clinical care, healthy and affordable food, good schools, and/or economic opportunities?

To help answer these questions, the GBD U.S. Health Disparities Collaborators at NIH, in partnership with IHME, have developed a comprehensive database and interactive data visualization tool that provides life expectancy and all-cause mortality by race and ethnicity for 3,110 U.S. counties from 2000-2019. Efforts are underway to expand the database to include causes of death and risk factors by race/ethnicity and education, as well as to disaggregate some of the major racial-ethnic groups.

Using IHME’s established model of comprehensive and replicable data collection, the joint effort aims to improve access to health data resources, bolster analytic approaches, and deliver user-friendly estimates to the wider research and health policy community. The collection’s standardized, comprehensive, historical, and real-time data can be the cornerstone for efforts to address disparities and advance health equity.

It is important to note that the Lancet study only included data from before the COVID-19 pandemic. The pandemic’s disproportionate effect on overall mortality and life expectancy has exacerbated existing health disparities. Disaggregated data are essential in helping to understand the underlying mechanisms of health disparities and guiding the development and implementation of interventions that address local needs.

As a clinician scientist, I have made a personal commitment at NIMHD to foster and encourage data collection with standardized measures, harmonization, and efficient data sharing to help us explore the nuances within all populations and their communities. Without these guiding principles for managing data, inequities remain unseen and unaddressed. Scientists, clinicians, and policymakers can all potentially benefit from this work if we use the data to inform our actions. It is an opportunity to implement real change in our NIH-wide combined efforts to reduce health disparities and improve quality of life and longevity for all populations.

Reference:

[1] Life expectancy by county, race, and ethnicity in the USA, 2000-19: a systematic analysis of health disparities. GBD US Health Disparities Collaborators. Lancet. 2022 Jul 2;400(10345):25-38.

Links:

Understand Health Disparities Series (National Institute on Minority Health and Health Disparities/NIH)

HD Pulse (NIMHD)

PhenX Social Determinants of Health Toolkit (NIMHD)

Institute for Health Metrics (University of Washington, Seattle)

NIH Support: The members of the GBD U.S. Health Disparities Collaborators at NIH include: National Heart, Lung, and Blood Institute; National Cancer Institute; National Institute on Aging; National Institute of Arthritis and Musculoskeletal and Skin Diseases; NIH Office of Disease Prevention; NIH Office of Behavioral and Social Science Research

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 17th 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

A grid of smiling people intermixed with dental health images

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.


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


All of Us: Partnering Together for the Future of Precision Medicine

Posted on by Dr. Francis Collins

All of Us Research Program
Credit: All of Us Research Program

Over the past year, it’s been so inspiring to watch tens of thousands of people across the country selflessly step forward for vaccine trials and other research studies to combat COVID-19. And they are not alone. Many generous folks are volunteering to take part in other types of NIH-funded research that will improve health all across the spectrum, including the more than 360,000 who’ve already enrolled in the pioneering All of Us Research Program.

Now in its second year, All of Us is building a research community of 1 million participant partners to help us learn more about how genetics, environment, and lifestyle interact to influence disease and affect health. So far, more than 80 percent of participants who have completed all the initial enrollment steps are Black, Latino, rural, or from other communities historically underrepresented in biomedical research.

This community will build a diverse foundation for precision medicine, in which care is tailored to the individual, not the average patient as is now often the case. What’s also paradigm shifting about All of Us is its core value of sharing information back with participants about themselves. It is all done responsibly through each participant’s personal All of Us online account and with an emphasis on protecting privacy.

All of Us participants share their health information in many ways, such as taking part in surveys, offering access to their electronic health records, and providing biosamples (blood, urine, and/or saliva). In fact, researchers recently began genotyping and sequencing the DNA in some of those biosamples, and then returning results from analyses to participants who’ve indicated they’d like to receive such information. This first phase of genotyping DNA analysis will provide insights into their genetic ancestry and four traits, including bitter taste perception and tolerance for lactose.

Results of a second sequencing phase of DNA analysis will likely be ready in the coming year. These personalized reports will give interested participants information about how their bodies are likely to react to certain medications and about whether they face an increased risk of developing certain health conditions, such as some types of cancer or heart disease. To help participants better understand the results, they can make a phone appointment with a genetic counselor who is affiliated with the program.

This week, I had the pleasure of delivering the keynote address at the All of Us Virtual Face-to-Face. This lively meeting was attended by a consortium of more than 2,000 All of Us senior staff, program leads with participating healthcare provider organizations and federally qualified health centers, All of Us-supported researchers, community partners, and the all-important participant ambassadors.

If you are interested in becoming part of the All of Us community, I welcome you—there’s plenty of time to get involved! To learn more, just go to Join All of Us.

Links:

All of Us Research Program (NIH)

Join All of Us (NIH)


Vast Majority of Pregnant Women with COVID-19 Won’t Have Complications, Study Finds

Posted on by Dr. Francis Collins

Pregnant woman
Credit: Getty Images/Eva-Katalin

It’s natural and highly appropriate for women to be concerned about their health and the wellbeing of their unborn babies during pregnancy. With the outbreak of the pandemic, those concerns have only increased, especially after a study found last spring that about 30 percent of pregnant women who become infected with SARS-CoV-2, the coronavirus that causes COVID-19, needed to be hospitalized [1].

But that early study didn’t clearly divide out hospitalizations that were due to pregnancy from those owing to complications of COVID-19. Now, a large, observational study has taken a more comprehensive look at the issue and published some reassuring news for parents-to-be: the vast majority of women who test positive for COVID-19 during their pregnancies won’t develop serious health complications [2]. What’s more, it’s also unlikely that their newborns will become infected with SARS-CoV-2.

The findings reported in JAMA Network Open come from a busy prenatal clinic that serves women who are medically indigent at Parkland Health and Hospital System, affiliated with the University of Texas Southwestern, Dallas. Researchers there, led by obstetrician Emily Adhikari, followed more than 3,300 pregnant women, most of whom were Hispanic (75 percent) or African American (14 percent). From March through August of this year, 252 women tested positive for COVID-19 during their pregnancies.

At diagnosis, 95 percent were asymptomatic or had only mild symptoms. Only 13 of the 252 COVID-19-positive women (5 percent) in the study developed severe or critical pneumonia, including just six with no or mild symptoms initially. Only 14 women (6 percent) were admitted to the hospital for management of their COVID-19 pneumonia, and all survived.

By comparing mothers with and without COVID-19 during pregnancy, the researchers found there was no increase in adverse pregnancy-related outcomes. Overall, women with COVID-19 during pregnancy were not more likely to give birth early on average. They weren’t at increased risk of dangerous preeclampsia, a pregnancy complication characterized by high blood pressure and organ damage, or an emergency C-section to protect the baby.

The researchers found no evidence that the placenta was compromised in any way by the SARS-CoV-2 infection. In most cases, newborns didn’t get sick. Only 6 of 188 infants (3 percent) tested positive for COVID-19. Most of those infected were born to mothers who were asymptomatic or had only mild illness.

This is all encouraging news. However, it is worth noting that mothers who developed severe COVID-19 before reaching 37 weeks, or well into the third trimester of pregnancy, were more likely to give birth prematurely. More research is needed, but the study also suggests that diabetes may increase the risk for severe COVID-19 in pregnancy.

This study’s bottom line is that most women who become infected with SARS-CoV-2 during pregnancy will do just fine. That doesn’t mean, however, that anyone should take this situation casually. The finding that 5 percent of pregnant women may become severely ill is still cause for concern. Plus not all researchers come to the same conclusion—an update to the first study cited in this post recently found a greater risk for pregnant women becoming severely ill from COVID-19 and giving birth prematurely.

Taken together, while there’s no need to panic about COVID-19 infection during pregnancy, it’s still a good idea for pregnant women and their loved ones to take extra precautions to protect their health. And, of course, follow the three W’s: Wear a mask, Watch your distance, and Wash your hands.

References:

[1] Characteristics of women of reproductive age with laboratory-confirmed SARS-CoV-2 infection by pregnancy status—United States, January 22–June 7, 2020. CDC COVID-19 Response Team. MMWR Morb Mortal Wkly Rep. 2020 Mar 27;69(12):343-346.

[2] Pregnancy outcomes among women with and without severe acute respiratory syndrome coronavirus 2 infection. Adhikari EH, Moreno W, Zofkie AC, MacDonald L, McIntire DD, Collins RRJ, Spong CY. JAMA Netw Open. 2020 Nov 2;3(11):e2029256.

Links:

Coronavirus (COVID) (NIH)

Combat COVID (U.S. Department of Health and Human Services, Washington, D.C.)

Data on COVID-19 during Pregnancy: Severity of Maternal Illness (Centers for Disease Control and Prevent, Atlanta)

COVID-19 Treatment Guidelines: Special Considerations in Pregnancy (NIH)

Emily Adhikari (University of Texas Southwestern Medical Center, Dallas)


Study Highlights Need for Continued Care of COVID-19 Survivors

Posted on by Dr. Francis Collins

Collage of people being cared for after contracting COVID-19
Credit: Composed of images from Getty

The past several months have shown that most people hospitalized with COVID-19 will get better. As inspiring as it is to see these patients breathe on their own and converse with their loved ones again, we are learning that many will leave the hospital still quite ill and in need of further care. But little has been published to offer a detailed demographic picture of those being discharged from our nation’s hospitals and the types of community-based care and monitoring that will be needed to keep them on the road to recovery.

A recent study in the journal EClinicalMedicine helps to fill in those gaps by chronicling the early COVID-19 experience of three prominent hospitals in the Boston area: Massachusetts General Hospital, Brigham and Women’s Hospital, and Newton-Wellesley Hospital. These data were reported from a patient registry of 247 middle-aged and older COVID-19 patients. The patients were admitted over three weeks last March into one of these hospitals, which are part of New England’s largest integrated health network.

The data confirm numerous previous reports that COVID-19 disproportionately affects people of color. The researchers, led by Jason H. Wasfy and Cian P. McCarthy, Massachusetts General Hospital and Harvard Medical School, Boston, found a large number of their patients were Hispanic (30 percent) or Black (10 percent). Wasfy said these numbers could be driven by many factors, including a low income, more family members living in one home, greater difficulty accessing healthcare, presence of chronic illness (health disparities), and serving as essential workers during the pandemic.

The researchers also tracked the patients after discharge for about 80 days. About a third of patients left the hospital for a post-acute care facility to continue their rehabilitation. After discharge, many required supplemental oxygen (15 percent), tube feeding (9 percent), or treatment with medications including antipsychotics and prescription painkillers (16 percent). About 10 percent were readmitted to the hospital within weeks or months of their initial discharge.

Wasfy and colleagues also found:

· Many patients undergoing treatment were enrolled in Medicaid (20 percent) or both Medicaid and Medicare (12 percent).

· A substantial number also were retired (36 percent) or unemployed (8.5 percent), highlighting the role of non-occupational spread. Many others worked in the hospitality industry, healthcare, or public transportation.

· A large proportion (42 percent) of hospitalized patients required intensive care. The good news is that most of them (86 percent) ultimately recovered enough to be discharged from the hospital. Tragically, 14 percent—34 of 247 people—died in the hospital.

These findings represent hospitals in just one notable American city hard hit early in the pandemic. But they spotlight the importance of public health efforts to prevent COVID-19 among the most vulnerable and reduce its most devastating social impacts. These are critical points, and NIH has recently begun supporting community engagement research efforts in areas hardest hit by COVID-19. With this support and access to needed post-discharge care, we aim to help more COVID survivors stay on the road to a full recovery.

Reference:

[1] Early clinical and sociodemographic experience with patients hospitalized with COVID-19 at a large American healthcare system. McCarthy CP et al. EClinicalMedicine. August 19, 2020.

Links:

Coronavirus (COVID-19) (NIH)

Massachusetts General Hospital (Boston)

Brigham and Women’s Hospital (Boston)

Newton-Wellesley Hospital (Newton, MA)

Jason Wasfy (Massachusetts General Hospital)


Discussing Cancer Health Disparities

Posted on by Dr. Francis Collins

Cancer Health Disparities
It was my pleasure to offer virtual remarks for the opening plenary session of the 13th Annual Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved Virtual Conference. The session was hosted by the American Association for Cancer Research (AACR) on October 2, 2020. I started things off speaking about factors that influence racial health disparities, including cancer disparities, and the need for greater workforce diversity. This videoconference image shows me with the panel members for the opening session. They are (starting top left to right) John Carpten, University of Southern California Keck School of Medicine, Los Angeles; Patricia LoRusso, Yale School of Medicine, New Haven, CT; Francis Collins; Brian Rivers, Morehouse School of Medicine; Atlanta; Chanita Hughes-Holbert, Medical University of South Carolina, Charleston; Mariana Stern, University of Southern California Keck School of Medicine, Los Angeles; Clayton Yates, Tuskegee University, AL; and Robert Winn, Virginia Commonwealth University Massey Cancer Center, Richmond.

COVID-19 Brings Health Disparities Research to the Forefront

Posted on by Dr. Francis Collins

Zoom conversation between Francis Collins and Eliseo Perez-Stable

The coronavirus 2019 (COVD-19) pandemic has brought into sharp focus many of the troubling things that we already knew about health disparities in the United States but have failed to address. With the bright light now shining on this important issue, it is time to talk about the role research can play in reducing the disproportionate burden of COVID-19, as well as improving the health of all people in our great nation. 

In recent weeks, we’ve seen a growing list of disturbing statistics about how blacks, Hispanics, tribal communities, and some other racial, ethnic, and disadvantaged socioeconomic groups are bearing the brunt of COVID-19. One of the latest studies comes from a research team that analyzed county-by-county data gathered about a month ago. Their findings? The 22 percent of U.S. counties that are disproportionately black accounted for 52 percent of our nation’s COVID-19 cases and 58 percent of COVID-19 deaths. In a paper awaiting peer review, the team, led by Emory University, Atlanta, and amfAR, the Foundation for AIDS Research, Washington, DC., noted that neither the size of the county nor whether it was urban or rural mattered [1].

Recently, I had an opportunity to discuss the disparate burden of COVID-19 with Dr. Eliseo Pérez-Stable, Director of NIH’s National Institute on Minority Health and Health Disparities (NIMHD). Besides leading an institute, Dr. Pérez-Stable is a widely recognized researcher who studies various factors that contribute to health disparities. Our conversation took place via videoconferencing, with him linking in from his home in Washington, D.C., and me from my home in nearby Maryland. Here’s a condensed transcript of our chat:

Collins: Eliseo, you and I recently had a chance to have a pretty intense discussion with the Congressional Black Caucus about health disparities and the COVID-19 pandemic. So, could you start off with a little bit about what populations are being hit hardest?

Pérez-Stable: Collecting data about disease incidence and mortality on the basis of race and ethnicity and other important demographic factors, like socioeconomic status, had really been absent in this pandemic until recently.

Part of that I think is entirely understandable. Hospitals were pressed with a surge of very sick patients, and there was a certain amount of fear and panic in the community. So, people were not completing all these forms that usually get turned in to the health departments and then forwarded to the CDC. If you go back in history, similar things happened in the early 1980s with the HIV epidemic. We weren’t collecting data on race and other sociodemographic variables initially. But, with time, we did complete these data and a picture emerged.

With the COVID-19 pandemic, obviously, the outcomes are much faster, with over 60,000 deaths in just a matter of three months. And we started to see reports, initially out of Connecticut, Milwaukee, Chicago, and New Orleans, that African Americans were dying at a disproportionate rate.

Now, the initial—and I think still the most likely—explanation for this higher mortality relates to two factors. The first is a higher rate of co-morbidities. We know that if you have cardiovascular disease, more than mild obesity, or diabetes, you’re more likely to get severe COVID-19 and potentially die from it. So, we could have just said, “Aha! It’s obvious why this population, and others with higher rates of co-morbidities might be expected to have higher rates of severe disease and higher mortality.”

But there is a second factor that relates to getting infected, for which we have much-less clear data. There was recently a map in The Washington Post showing the distribution of the rate of COVID-19 infections in Washington, D.C., by ward. The highest rates are in the wards that are east of the Anacostia River, which are about 90 percent African American. So, there is an appearance of a correlation between the proportion of African Americans in the community and the rate of Covid-19 infection. Now why could that be?

Collins: Yes, what explains that?

Pérez-Stable: Well, I think crowding is part of it, certainly in this neighborhood. A second option would be multiple families living under one roof.

Collins: So, you can’t exactly practice physical distancing very well in that situation.

Pérez-Stable:  Absolutely. You and I can go into our respective rooms, probably have our respective bathrooms, and socially and physically isolate from the rest of the household if need be. Many people can’t do that. They have three generations in one small apartment, all using one bathroom, maybe two bedrooms for six or eight people.

So, we do face different conditions by which one casual infection can lead to much more community transmission. But much information still needs to be ascertained and there does seem to be some regional variance. For example, in Chicago, Milwaukee, and Atlanta, the reports, at least initially, are worse than they are in Connecticut or Florida. Also, New York City, which has been the epicenter of the U.S. for this pandemic, has an increased rate of infections and mortality among Latino-Hispanic populations as well. So, it isn’t isolated to an African-American issue.

Collins: What about access to healthcare?

Pérez-Stable: Again, we can postulate based on a little bit of anecdote and a little bit of data. I’m a general internist by background, and I can see the enormous impact this pandemic has had on healthcare settings.

First, elective ambulatory visits and elective admissions to the hospital have been postponed, delayed, or cancelled. About 90 percent of ambulatory care is occurring through telemedicine or telephone connections, so in-person visits are occurring only for really urgent matters or suspected COVID-19.

If you have health insurance and can use systems, you can probably, through telephone triage with a nurse, get either approval or nonapproval for being tested [for COVID-19], drive to a place, get tested by someone wearing protective equipment, and never actually have to visit with anyone. And you’ll get your result now back as soon as one day, depending on the system. Now, if you’re insured, but don’t really know how to use systems, navigating all these things can be a huge challenge. So, that could be a factor.

People are also afraid to come to clinic, they’re afraid to show up at the emergency room, because they’re afraid to get infected. So, they’re worried about going in, unless they get very sick.  And when they get very sick, they may be coming in with more advanced cases [of COVID-19].

So, telephone triage, advice from clinicians on the phone, is critical. We are seeing some doctors base their decisions on whether a person is able to breathe okay on the phone, able to say a whole sentence without catching their breath. These kinds of basic things that we learned in clinical medicine training are coming into play in a big way now, because we just cannot provide the kind of care, even in the best of circumstances, that people may need.

Of course, uninsured patients will have even more barriers, although everyone in the healthcare system is trying their best to help patients when they need to be helped, rather than depend on insurance triage.

Collins: A big part of trying to keep the disease from spreading has been access to testing so that people, even those with mild symptoms, can find out if they have this virus and, if so, quarantine and enable public health workers to check out their contacts. I’m guessing, from what you said, that testing has been happening a lot less in urban communities that are heavily populated by African Americans and that further propagates the spread of the disease. Am I right?

Pérez-Stable: So far, most testing has been conducted on the basis of symptoms. So, if you have enough symptoms that you may potentially need to be hospitalized, then you get tested. Also, if you’re a healthcare worker who had contact with a COVID-19 patient, you might be tested, or if there’s someone you’ve been very close to that was infected, you may be tested. So, I don’t think so much it’s a matter of disproportionate access to testing by one group or another, as much as that the overall triage and selection criteria for testing have been rather narrow. Up until now, it has not been a simple process to get tested for COVID-19. As we scale up and get better point-of-care tests and much easier access to getting tested, I think you’ll see dissemination across the board.

Collins: It’s interesting we’re talking about this, because this is an area that Congress recently came to NIH and said, “We want you to do something about the testing by encouraging more technology, particularly technology that can be distributed to the point-of-care, and that is out in the community.”

Everyone wants a test that gives you a quick turnaround, an answer within an hour, instead of maybe a day or two. A big part of what NIH is trying to do is to make sure that if we’re going to develop these new testing technologies, they get deployed in places that otherwise might not have much access to testing—maybe by working through the community health centers. So, we’re hoping we might be able to make a contribution there.

Pérez-Stable: The economic factors in this pandemic are also huge. A significant proportion of the population that we’re referring to—the disparity population, the minorities, the poor people—work in service jobs where they’re on the front line. They were the restaurant servers and people in the kitchen, they’re still the bus drivers and the Uber drivers, and those who are working in pharmacies and supermarkets.

On the one hand, they are at higher risk for getting infected because they’re in more contact with people. On the other hand, they’re really dependent on this income to maintain their household. So, if they test positive or get exposed to COVID-19, we really do have a challenge when we ask them to quarantine and not go to work. They’re not in a position where they have sick leave, and they may be putting themselves at risk for being laid off.

Collins: Eliseo, you’ve been studying health disparities pretty much your whole research career. You come from a community where health disparities are a reality, having been born in Cuba and being part of the Latino community. Did you expect that COVID-19 would be this dramatic in the ways in which it has so disproportionately affected certain groups?

Pérez-Stable: I can’t say that I did. My first thought as a physician was to ask: “Is there any reason to think that an infectious agent like COVID-19 would disproportionally infect or impact any population?” My gut answer was “No.” Infectious diseases usually seem to affect all people; sort of equal opportunity invaders. There are some data that would say that influenza and pneumonia are not any worse among African Americans or Latinos than among whites. There are some slight differences in some regions, but not much.

Yet I know this a question that NIH-funded scientists are interested in addressing. We need to make sure that there aren’t any particular susceptibility factors, possibly related to genetics or the lung epithelium, that lead to such different COVID-19 outcomes in different individuals. Clearly, something must be going on, but we don’t know what that is. Maybe one of those factors tracks through race or ethnicity because of what those social constructs represent.

I recently listened to a presentation by Rob Califf, former FDA Commissioner, who spoke about how the pandemic has created a spotlight on our disparities-creating system. I think much of the time this disparities-creating system is in the background; it doesn’t really affect most people’s daily lives. Now, we’re suddenly hit with a bucket of cold water called COVID-19, and we’re saying what is going on and what can we do about it to make a difference. I hope that, once we begin to emerge from this acute crisis, we take the opportunity to address these fundamental issues in our society.

Collins: Indeed. Let’s talk about what you’re doing at NIMHD to support research to try to dig into both the causes of health disparities and the interventions that might help.

Pérez-Stable: Prompted by your motivation, we started talking about how minority health and health disparities research could respond to this pandemic. In the short-term, we thought along the lines of how can we communicate mitigation interventions, such as physical distancing, in a more effective way to our communities? We also asked what we could do to enhance access to healthcare for our populations, both to manage chronic conditions and for diagnosis and treatment of acute COVID-19.

We also considered in the mid- and long-term effects of economic disruption—this surge of unemployment, loss of jobs, loss of insurance, loss of income—on people’s health. Worries include excess use of alcohol and other substances, and worsening of mental and emotional well-being, particularly due to severe depression and chronic mental disorders not being well controlled. Intimate partner violence has already been noted to increase in some countries, including France, Spain, and the United States, that have gone on physical distancing interventions. Similarly, child abuse can be exacerbated under these circumstances. Just think of 24/7 togetherness as a test of how people can hold it together all the time. I think that that can bring out some fragility. So, interventions to address these, that really activate our community networks and community-based organizations, are real strengths. They build on the resilience of the community to highlight how we can get through this difficult period of time.

I feel optimistic that science will bring answers, in the form of both therapies and vaccines. But in the meantime, we have a way to go and we a lot to do.  

Collins: You mentioned the promise of vaccines. The NIH is working intensively on this, particularly through a partnership called ACTIV, Accelerating Covid-19 Therapeutic Interventions and Vaccines. We hope that in several more months, we’ll be in a position to begin testing these vaccines on a large scale, after having some assurances about their safety and efficacy. From our conversation, it sounds like we should be trying to get early access to those vaccines to people at highest risk, including those in communities with the heaviest burden. But how will that be received? There hasn’t always been an easy relationship between researchers, particularly government researchers, and the African-American community.

Pérez-Stable: I think we have learned from our historical experiences that mistrust of the system is real. To try to pretend that it isn’t there is a big mistake. Address these concerns upfront, obtain support from thought leaders in the community, and really work hard to be inclusive. In addition to vaccines, we need participation in any clinical trials that are coming up for therapeutics.

We also need research on how optimally to communicate this with all the different segments of the population. This includes not just explaining what it means to be eligible for vaccine trials or therapeutic trials, but also discussing the consequences of, say, getting tested, whether it be a viral or antibody test. What does the information mean for them?  

Most people just want to know “Am I clear of the virus or not?” That certainly could be part of the answer, but many may require more nuanced responses. Then there’s behavior. If I’m infected and I recover, am I safe to go back out and do things that other people shouldn’t do? We’d love to be able to inform the population about that. But, as you know, we don’t really have the answers to that just yet.

Collins: Good points. How do we make sure, when we’re trying to reach out to populations that have shouldered such a heavy burden, that we’re actually providing information in a fashion that is readily understood?

Pérez-Stable:  One thing to keep in mind is the issue of language. About 5 to 10 percent of U.S. adults don’t speak English well. So, we really have to address the language barrier. I also want to highlight the challenge that some tribal nations are facing. Navajo country has had particular challenges with COVID-19 infections in a setting of minimal medical infrastructure. In fact, there are communities that have to go and get their water for the day at a distant site, so they don’t have modern plumbing. How can we recommend frequent hand washing to someone who doesn’t even have running water at home? These are just a few examples of the diversity of our country that need to be addressed as we deal with this pandemic.

Collins:  Eliseo, you’ve given us a lot to think about in an obviously very serious situation. Anything you’d like to add?

Pérez-Stable:  In analyzing health outcomes, researchers often think about responses related to a metabolic pathway or to a gene or to a response to a particular drug. But as we use the power of science to understand and contain the COVID-19 pandemic, I’d like to re-emphasize the importance of considering race, ethnicity, socioeconomic status, the built environment, the social environment, and systems. Much of the time these factors may only play secondary roles, but, as in all science related to humans, I think they have to be considered. This experience should be a lesson for us to learn more about that.

Collins: Thank you for those wonderful, inspiring words. It was good to have this conversation, Eliseo, because we are the National Institutes of Health, but that has to be health for everybody. With COVID-19, we have an example where that has not turned out to be the case. We need to do everything we can going forward to identify ways to change that.

Reference:

[1] Assessing Differential Impacts of COVID-19 on Black Communities. Millet GA et al. MedRxiv. Preprint posted on May 8, 2020.

Links:

Video: Francis Collins and Eliseo Pérez-Stable on COVID-19 Health Disparities (NIH)

Coronavirus (COVID-19) (NIH)

Director’s Corner (National Institute on Minority Health and Disparities/NIH)

COVID-19 and Racial/Ethnic Disparities. Webb Hooper M, Nápoles AM, Pérez-Stable EJ.JAMA. 2020 May 11.

amfAR Study Shows Disproportionate Impact of COVID-19 on Black Americans, amfAR News Release, May 5, 2020.



NIMHD Turns 10

Posted on by Dr. Francis Collins

NIMHD Anniversary Symposium
Happy 10th anniversary to NIH’s National Institute on Minority Health and Health Disparities (NIMHD). To mark the occasion, the NIMHD held an informative anniversary scientific symposium on March 3, 2020 at NIH that focused on “Innovations to Promote the Health Equity Agenda.” It was my pleasure to take part in the opening session, where I had a chance to pose for this photo with my colleague and NIMHD Director Eliseo Pérez-Stable. Over the past 30 years, NIMHD and its predecessors, along with their partners and collaborators, have proven that health disparities are real. Everyone deserves to live a healthy life, and health disparities challenge our American sense of fairness. Within the next 30 years, a majority of our nation’s population is projected to be non-white. With this coming demographic shift, it’s more important now than ever for researchers to study minority health and health disparities to understand the health of all people. Credit: NIH.


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