Topic: Access To and Equity in Health Care

Rebecca Seltzer elected to American Academy of Pediatrics Council on Foster Care, Adoption, and Kinship Care Executive Committee

Berman Institute associate faculty member Rebecca Seltzer, an Assistant Professor of Pediatrics at the Johns Hopkins School of Medicine, has been elected to the American Academy of Pediatrics Council on Foster Care, Adoption, and Kinship Care Executive Committee.

Dr. Seltzer’s research involves improving care for children with medical complexity, with a particular focus on those in the child welfare system. She is exploring the ethical and policy challenges that arise when caring for this vulnerable population, including challenges related to medical decision-making, conducting research with children in foster care, and gaps in community supports and placement options for children with medical complexity. She is an attending physician at the Harriet Lane Primary Care clinic, where she oversees pediatric residents and medical students.

“This election is an honor and I am excited to take on more of a leadership role in foster care advocacy and policy,” said Dr. Seltzer.

The Council on Foster Care, Adoption, and Kinship Care promotes the health and development of children and youth who are at risk for or have experienced family disruption. The Council accomplishes this by developing policy guidelines for comprehensive and trauma-informed care, advocating for child and youth to thrive, and providing education and support to the members of the American Academy of Pediatrics, other health professionals, and the child welfare community.

Dr. Seltzer is a former Hecht-Levi Fellow at the Berman Institute. She received her BA from the University of Virginia as an Echols Scholar, received her MD from the Perelman School of Medicine at the University of Pennsylvania, completed pediatric residency training at the Children’s Hospital of Philadelphia, completed fellowship training in Academic General Pediatrics and ethics at Johns Hopkins, and received an MHS from the Johns Hopkins Bloomberg School of Public Health.

Eyeglasses for School Kids Boosts Academic Performance

Students who received eyeglasses through a school-based program scored higher on reading and math tests, Johns Hopkins researchers from the Wilmer Eye Institute and School of Education found in the largest clinical study of the impact of glasses on education ever conducted in the United States. The students who struggled the most academically showed the greatest improvement.

The study, with implications for the millions of children who suffer from vision impairment but lack access to pediatric eye care, was published Sept. 9, 2021, by JAMA Ophthalmology.

“We rigorously demonstrated that giving kids the glasses they need helps them succeed in school,” said senior author Megan Collins, a pediatric ophthalmologist at the Wilmer Eye Institute, associate faculty at the Berman Institute of Bioethics, and co-director of the Johns Hopkins Consortium for School-Based Health Solutions. “This collaborative project with Johns Hopkins, Baltimore City and its partners has major implications for advancing health and educational equity all across the country.”

The team studied students who received eye examinations and glasses through the Vision for Baltimore program, an effort launched in 2016 after Johns Hopkins researchers identified an acute need for vision care among the city’s public school students: as many as 15,000 of the city’s 60,000 pre-K through 8th-grade students likely needed glasses though many didn’t know it or have the means to get them.

Vision for Baltimore, which is beginning its sixth year, is operated and funded in partnership with the Johns Hopkins schools of Education and Medicine, Baltimore City Public Schools, the Baltimore City Health Department, eyewear brand Warby Parker, and national nonprofit Vision To Learn. The Baltimore health department conducts screenings, Vision To Learn performs eye exams and Warby Parker donates the glasses. In addition to providing more than $1 million in support, Johns Hopkins works closely with the program team to provide technical assistance.

In five years Vision for Baltimore has tested the vision of more than 64,000 students and distributed more than 8,000 pairs of glasses. The Johns Hopkins study is the most robust work to date evaluating whether having glasses affects a child’s performance in school.

The three-year randomized clinical trial, conducted from 2016 to 2019, analyzed the performance of 2,304 students in grades 3 to 7 who received screenings, eye examinations and eyeglasses from Vision for Baltimore. The team looked at their scores on standardized reading and math tests, measuring both 1-year and 2-year impact.

Reading scores increased significantly after one year for students who got glasses, compared to students who got glasses later. There was also significant improvement in math for students in elementary grades.

Researchers found particularly striking improvements for girls, special education students, and students who had been among the lowest performing.

“The glasses offered the biggest benefit to the very kids who needed it the most – the ones who were really struggling in school,” Collins said.

The overall gains for students with glasses were essentially equivalent to two to four months of additional education compared to students without glasses, said lead author Amanda J. Neitzel, deputy director of evidence research at the Johns Hopkins Center for Research and Reform in Education. For students performing in the lowest quartile and students participating in special education, wearing glasses equated to four to six months of additional learning—almost half a school year.

“This is how you close gaps,” Neitzel said.

The academic improvements seen after one year were not sustained over two years. Researchers suspect this could be a result of students wearing their glasses less over time, possibly due to losing or breaking them.

To maintain the academic achievement, the researchers say in addition to providing the initial exams and glasses, school-based vision programs should develop stronger efforts to make sure children are wearing the glasses and to replace them if needed.

“This study, grounded in thorough and rigorous research, has proven our most fundamental assumption in launching Vision for Baltimore six years ago – that providing kids glasses in their schools will significantly improve academic success,” said Johns Hopkins President Ron Daniels. “These results validate the dedication of all of the program’s committed partners, from the principals, staff and teachers across Baltimore City schools to the optometrists at Vision to Learn and the school vision advocates from Johns Hopkins. Looking forward, we hope to work with our state and city leaders to ensure that this impactful program has sustainable funding for years to come.”

Analysis of Medical Records Finds Physicians Are More Likely to Doubt Black Patients

With the implementation of the 21st Century Cures Act on April 5, healthcare providers are now required to give their patients free access to all the health information in their electronic medical records. Black patients are much more likely than white patients to discover language in those records that indicates they are not believed by their physicians, according to a new study by Johns Hopkins faculty published in the Journal of General Internal Medicine.

“We set out to see if we could identify linguistic mechanisms through which physicians communicate disbelief of patients in medical records and, if so, to explore racial and gender differences in the use of such language,” said Mary Catherine Beach, a faculty member in JHU’s schools of medicine and public health, and its bioethics institute. “Our analysis of medical record language suggests Black patients are less likely to be believed by physicians. The bias reflected in those medical records may in turn affect care from future clinicians.”

Beach and her Hopkins Medicine colleague Somnath Saha first noticed in the medical records of patients with sickle cell disease that doctors and nurses were signaling disbelief in their patients’ reports of pain. They began examining additional records to see if this phenomenon extended to patients receiving treatment for other conditions. Working with a linguist and a computer scientist they identified three aspects of language in clinic notes by which physicians communicate disbelief of patients:

  • Quotation marks around patients’ words (e.g., had a “reaction” to the medication)
  • Specific “judgment” words that suggest doubt (e.g., ‘claims’ or ‘insists’)
  • Evidentials, a sentence construction in which patients’ symptoms or experience is reported as hearsay.

“We evaluated the prevalence of these features in over 9000 notes in one clinic, then tested differences by race and gender. We found all 3 of these forms of language more often in the records of Black patients than white patients. Women’s records were somewhat more likely than men’s to have quotes, but not judgment words or evidentials,” said Saha. “Some of this language reflects how clinicians are taught to document things, and there are reasons to use quotes and evidentials that don’t necessarily cast doubt on what patients are saying. But if it’s just benign word use, why would we see a difference in their application by patients’ race and gender? That’s what makes such language so insidious.”

Beach and Saha note that the prevalence of electronic medical records means that one clinician’s notes will follow a patient wherever they go in the healthcare system and could adversely impact the patient’s care moving forward. According to Beach, Hopkins Medicine has been extremely receptive to addressing the impact of biased language on patient care, asking her to speak at Grand Rounds, to residents, and to all current medical students about her and Saha’s research.

“Clinicians know that patients are sometimes mistaken or even deceptive,” said Beach. “But if we also know there is racial bias in the way patients’ credibility gets assessed, we must revisit the certainty we have in our own impressions. We have to question ourselves before we question the statements of others.”

Planning How to Allocate and Distribute a COVID-19 Vaccine

Researchers from the Berman Institute of Bioethics have co-authored a new report providing an ethical framework for making decisions about allocation and distribution of a COVID-19 vaccine during the initial period when such a vaccine has first been authorized for use and is still in limited supply.

Released by the Center for Health Security at Johns Hopkins Bloomberg School of Public Health, the report, Interim Framework for COVID-19 Vaccine Allocation and Distribution in the United States, proposes specific tiers of high-priority candidates for receiving a first vaccine based on this framework, including recognizing the contributions of essential workers who have been overlooked in previous allocation schemes:

Tier 1 includes those:

  • Most essential in sustaining the ongoing COVID-19 response.
  • At greatest risk of severe illness and death, and their caregivers.
  • Most essential to maintaining core societal functions.

Tier 2 includes those:

  • Involved in broader health provision.
  • Facing greater barriers to access care if they become seriously ill.
  • Contributing to maintenance of core societal functions.
  • Whose living or working conditions give them elevated risk of infection, even if they have lesser or unknown risk of severe illness and death.

The framework is guided by the following ethical principles, which the report authors believe should guide COVID-19 vaccine allocation and help identify more specific policy goals and objectives around vaccine policies:

  • Promotion of the common good, by promoting public health while enabling social and economic activity.
  • The importance of treating individuals fairly and promoting social equity, for example by addressing racial and ethnic disparities in COVID-19 mortality, and by recognizing the contributions of essential workers who have been overlooked in previous allocation schemes. 
  • The promotion of legitimacy, trust and a sense of community ownership over vaccine policy, while respecting the diversity of values and beliefs in our pluralist society.

The Berman Institute’s Anne Barnhill, Carleigh Krubiner and Alan Regenberg are among the co-authors, as is former Hecht-Levi Fellow Justin Bernstein, and Ruth Faden contributed.

You can access the new report here.

Vaccine Guidance Gains Global Attention

Health and Bioethics Experts: “The treatment of pregnant women in vaccine research
and deployment is unacceptable. Business as usual simply cannot continue.”

New Report Lays out Recommendations for Policymakers, Researchers, and Global Health Organizations on Including Pregnant Women in Epidemic Vaccine Development and Deployment

Even as health care responders valiantly battle the ongoing Ebola outbreak in the Democratic Republic of Congo, one highly vulnerable group is being denied a potentially life-saving vaccine: pregnant and lactating women. This and other recent epidemics of Zika, Lassa Fever, and Hepatitis E have shown how infectious disease outbreaks can severely – and at times uniquely – affect the health of pregnant women and their offspring. Despite a significantly higher risk of serious disease and death, vaccines against these devastating diseases are rarely developed and approved for pregnant women.

Changing institutional and government practices so that we have vaccines to offer pregnant women in an epidemic is one of 22 long overdue recommendations contained in the new report Pregnant Woman & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research and Response, issued in December 2018 by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group – a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy. The report, aiming to ensure that pregnant women are no longer excluded from receiving vaccines against emerging infectious diseases, has received widespread media attention, including:

“The self-perpetuating cycle of excluding pregnant women from research and from the benefits of vaccination must end,” said Carleigh Krubiner, a lead author of the report jointly appointed at the Johns Hopkins Berman Institute of Bioethics and the Center for Global Development. “With global efforts now underway to develop a range of vaccines against devastating epidemic threats, we have to make sure pregnant women are on the agenda, so they will never again be left unprotected in the face of future outbreaks.”

The report lays out concrete steps for equitably addressing the needs of pregnant women in public health preparedness, vaccine research and development, and the deployment of vaccines during epidemics. Its recommendations include:

  • During an epidemic, the default should be to offer vaccines to pregnant women—not the reverse.
  • Vaccines that can be safely given to pregnant women need to be developed. For these vaccines, evaluation in pregnancy needs to occur as early in the clinical development process as possible.
  • During an epidemic, decisions about whether pregnant women will be offered vaccines should consider not only any potential risks of the vaccine but also, and importantly, the risks pregnant women and their babies face if vaccine is denied.
  • All decisions about inclusion or exclusion of pregnant women should be informed by those with the relevant expertise in maternal and neonatal health as well as in vaccinology and virology.
  • The perspectives of pregnant women themselves should inform vaccine research and deployment decisions that may mean life or death for them and/or their babies.

The full recommendations are available at http://vax.pregnancyethics.org/prevent-guidance.

“The way we have treated pregnant women in vaccine research and deployment is utterly unacceptable. Business as usual cannot be permitted to continue,” said Ruth R. Faden, a lead author of the report and founding director of the Johns Hopkins Berman Institute of Bioethics. “Ensuring that pregnant women affected by outbreaks have safe and effective vaccines is not only a matter of justice and health equity, it’s also critical to the public health response.”

That pregnant women affected by the ongoing Ebola crisis in the Democratic Republic of the Congo are not being offered vaccine demonstrates how urgent and serious the consequences are of the status quo exclusions of pregnant women from vaccine research and delivery. In recent UNICEF interviews, pregnant women “clearly articulated that they wanted to choose whether to be vaccinated or not.”  As one woman said, ‘now there is no option, you just send us to death.’”

“As we continue to develop new vaccines against pathogens with serious and often lethal consequences in pregnancy, pregnant women must be on the agenda every step of the way,” said Ruth A. Karron, a lead author of the report and director of the Center for Immunization Research and the Johns Hopkins Vaccine Initiative at Johns Hopkins Bloomberg School of Public Health. “We simply can’t continue to fail pregnant women as we develop new vaccines against emerging threats.  We need to generate an evidence base for safe and effective use of these vaccines during pregnancy.”

To read the full report visit vax.pregnancyethics.org/prevent-guidance. In conjunction with the report release, PREVENT has also released a video that discusses the risks of the status quo, and describes why urgent action is needed. You can watch the video at vax.pregnancyethics.org.

PREVENT is a grant-funded project led by faculty at Johns Hopkins University alongside co-investigators at Georgetown University and the University of North Carolina at Chapel Hill, with external contributions from Working Group Members. The PREVENT Project is funded by the Wellcome Trust (203160/Z/16/Z).

 

Prof. Unguru Decries Drug Shortages

Calling access to essential medicines a basic human right, Berman Institute professor Yoram Unguru made a compelling argument for the United States Food & Drug Administration to establish an Essential Medicines List, as a first step in ensuring that the population has access at all times, and in sufficient amounts, to medicines that satisfy their priority health care needs.

Speaking at a Nov. 27 Washington, DC, meeting “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions,” convened in cooperation with the U.S. FDA, Dr. Unguru explained that shortages of vital drugs have harmed countless patients, been implicated in patient deaths between 2010-2012, and had a lasting detrimental impact on clinical research, threatening researchers’ ability to achieve meaningful progress in improving the lives of children with cancer.

“Typically, we only get one chance to cure children with cancer. If that opportunity is missed, it’s rare that we are able to cure them of their disease,” said Dr. Unguru.

“At the height of the shortages, a survey of medical oncologists found that a staggering 83% of oncologists weren’t able to prescribe their preferred chemotherapy agent. More than 75% had to make a major change in treatment such as choosing a different treatment regimen or substitute different drugs during the treatment. And over 40% had to delay the start of treatment. Two surveys of childhood cancer specialists, one in 2015 and again just last year, found the two out of three pediatric oncologists reported that their patients’ clinical care was compromised by the shortages.”

View Dr. Unguru’s full comments here.

The purpose of the Nov. 27 meeting was to give stakeholders including health care providers, patients, manufacturers, wholesalers, pharmacists, pharmacy benefit managers, veterinarians, public and private insurers, academic researchers, and the public, the opportunity to provide input on the underlying systemic causes of drug shortages and to make recommendations for actions to prevent or mitigate drug shortages.

Dr. Unguru called on the FDA to join many other countries throughout the world in adopting the World Health Organization’s essential medicines list (EML). As defined by the WHO, essential medicines: “Satisfy the priority health care needs of the population. Medicines included in the EML are both clinically effective and cost effective and are to be available at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford.”

The current WHO Essential Medicines List for Children includes 18 chemotherapy agents and 4 supportive care medicines.

“This may shock you to hear, but over the past 2.5 years, nearly two-thirds of these essential medicines for children with cancer have been or are currently in short supply in the U.S.  In fact, at this time, 5 of the 18 essential medicines, nearly 30%, are in short supply in the U.S.,” said Dr. Unguru.

Dr. Unguru is a pediatric hematologist/oncologist with joint faculty appointments at The Herman and Walter Samuelson Children’s Hospital at Sinai and The Johns Hopkins Berman Institute of Bioethics, where he is a Core Faculty member. He is also an Assistant Professor in the Johns Hopkins School of Medicine. Dr. Unguru is a member of the Children’s Oncology Group, and leads a multidisciplinary, transnational working group examining the ethical and policy implications of chemotherapy shortages in childhood cancer.

He has appeared, among other places, in the New York Times and on NPR to discuss allocation of scarce children’s cancer-treating drugs.

“Given the continued shortages of drugs, especially generic injectable drugs that are essential to the treatment of children with cancer, the United States should create an EML for pediatric oncology drugs,” Dr. Unguru said.

“Ultimately, what is needed is greater involvement by government.  Congress must grant federal authorities the ability to ensure that patients in need have access to medications.  Children with cancer should not have to continue to suffer because of inaction and a lack of will; they deserve better.”

Maria Merritt, PhD

HONORS AND AWARDS

  • Hastings Center Fellow, elected December 2020
  • Recognition for teaching excellence as principal instructor of JHSPH course, Ethics of Public Health Practice in Developing Countries (221.616.01: classroom), 4th term 2016-17, 2015-16, 2014-15, 2012-13, and 2011-12; (221.616.81: online), 4th term 2017-18 and 2016-17; and as principal instructor of Ethics in Global Health Practice (604.603.86), 2018-19.
  • Student Assembly Special Recognition Award for Outstanding Commitment to Student Success, 2017
  • Principal Investigator, NIH award number 1R01AI114458-01A1, 2015-19, “Assessing Social Justice in Economic Evaluation to Scale up Novel MDR-TB Regimens” (award issued by National Institute of Allergy and Infectious Diseases)
  • Recognition for teaching excellence as principal instructor of JHSPH course, Ethics of Public Health Practice in Developing Countries (221.616.01), 4th term 2015-16; 2014-15; 2012-13; and 2011-12
  • Co-Investigator, NIH award number 1R01AI085147-01A1, 2010-14, “Ancillary Care in Community-Based Research: Deciding What to Do” (PI Holly A. Taylor; award issued by National Institute of Allergy and Infectious Diseases)
  • Greenwall Faculty Scholars Program in Bioethics career development award, 2009-12, “Researchers’ Obligations in Community-Based Research: Resolving Dilemmas of Care”
  • Faculty Innovation Fund, 2007-08, Johns Hopkins Bloomberg School of Public Health, “Ancillary Care in Public Health Intervention Research in Resource-Limited Settings: Researchers’ Practices and Decision-Making”(Co-PI Holly A. Taylor)
  • Faculty Fellow, Edmond J. Safra Foundation Center for Ethics, Harvard University, 2005-06
  • Postdoctoral Fellow, Department of Clinical Bioethics, National Institutes of Health, 2000-02
  • Rhodes Scholar, Oxford University, 1987-90

Mary Catherine Beach, MD, MPH

Dr. Beach is on the editorial board for Patient Education and Counseling and on the Advisory Board for Communication in Medicine. At Johns Hopkins, Dr. Beach serves as co-chair of an Institutional Review Board (IRB), Course Director of the Scholarly Concentrations Program (a course spanning 2 years in the School of Medicine curriculum that guides students through a mentored scholarly project), and Director of the TL1 Predoctoral Clinical Research training program (a year-long interdisciplinary program).