Research Area: Research Ethics

Berman Faculty share response to human gene editing claims

A renegade. But not a charlatan.

That was the opinion of a group of Berman Institute faculty about He Jiankhi, the Chinese scientist who claims to have used the gene-editing tool CRISPR to edit the embryos of twin girls that he said were born last month.

In the wake of He’s announcement, the Berman Institute held a Dec. 10 panel discussion, “Ethics, Policy, and Human Genome Editing—What’s Now? What’s Next?” for the faculty and students of the JHU School of Medicine’s Institute of Genetic Medicine (watch below).

Berman Institute Director Jeffrey Kahn was in Hong Kong to attend the Second International Summit on Human Genome Editing when the news of He’s actions broke.

“If true as reported – and He, who has now vanished from sight, has not published any data that would confirm his action – this would be an extremely premature and ethically problematic experiment in creating genetically modified children,” said Kahn.

Kahn was joined on the panel by Debra Mathews, who gave a brief scientific introduction to genetic modification, and Jeremy Sugarman, who outlined a number of the ethical issues raised by He’s actions, including lack of oversight, the possibility of off-target effects, the informed consent of the parents, the prospect of genetic enhancement raised by He’s actions, and the need for responsible follow-up, among others.

The panel stated that He’s actions would be illegal in many countries, including the United States, and that recent developments suggest that Chinese authorities are investigating their legality in his native country.  Such an experiment also violates the recommendations in the international consensus report issued in 2017.

“The creation of these gene-edited children violates virtually every existing guideline, policy, norm, and value surrounding the use of this technology,” said Kahn, who was interviewed by numerous media outlets about He’s actions, including the Washington Post, NPR, and Vox.

Kahn said that the Berman Institute would continue to organize programs and provide additional ongoing response about the bioethical implications of human gene editing.

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.”

2018-19 Seminar Series

Leading bioethics scholars from around the world lecture on vital issues in the field at our biweekly Seminar Series. Lectures, held at lunchtime, are free and open to the public.

2018-2019 Berman Institute Seminar Series
Seminars are video recorded and posted on our YouTube channel.

Upcoming Seminars

May 13, 2019
Holly Fernandez Lynch, JD, MBE
“Evaluating IRB Quality and Effectiveness”
Seminar Details
Feinstone Hall

Past Seminars

September 24, 2018.
Jonathan Moreno, PhD
“Bioethics is Advocacy: Is That So Wrong?”

October 8, 2018
Travis Rieder, PhD
“Bioethics, Pain Medicine, and America’s Opioid Crisis”

October 29, 2018
Matteo Bonotti, PhD
“Opportunity Pluralism and Children’s Health”

November 12, 2018
Peter Buxtun
“Marked Men: In Case You Didn’t Know about Tuskegee”

February 11, 2019
Alex John London, PhD
“Ethical and Regulatory Issues With Autonomous Vehicles”

March 11, 2019
David S. Jones, MD, PhD

March 25, 2019
Marion Danis, MD
“Engaging the Public in Setting Health Care Priorities”

April 8, 2019
Brian Carter, MD
Hutzler-Rives Memorial Lecture: “Insights from patienthood: A pediatrician and bioethicist’s reflections on pediatric palliative care”

April 22, 2019
Effy Vayena, PhD
“Digital Health Ethics: The Systemic Oversight Approach”

Honoring an Immortal Contribution

Johns Hopkins University President Ronald J. Daniels and Paul B. Rothman, CEO of Johns Hopkins Medicine and dean of the medical faculty of the Johns Hopkins University School of Medicine, along with Berman institute Executive Director Jeffrey Kahn and descendants of Henrietta Lacks, recently announced plans to name a new multidisciplinary building on the Johns Hopkins East Baltimore campus in honor of Henrietta Lacks, who was the source of the HeLa cell line that has been critical to numerous advances in medicine.

Surrounded by descendants of Lacks, Daniels made the announcement at the 9th annual Henrietta Lacks Memorial Lecture in the Turner Auditorium in East Baltimore.

“Through her life and her immortal cells, Henrietta Lacks made an immeasurable impact on science and medicine that has touched countless lives around the world,” Daniels said. “This building will stand as a testament to her transformative impact on scientific discovery and the ethics that must undergird its pursuit. We at Johns Hopkins are profoundly grateful to the Lacks family for their partnership as we continue to learn from Mrs. Lacks’ life and to honor her enduring legacy.”

Henrietta Lacks’ contributions to science were not widely known until the 2010 release of the book The Immortal Life of Henrietta Lacksby Rebecca Skloot, which explored Lacks’ life story, her impact on medical science and important bioethical issues. In 2017, HBO and Harpo Studios released a movie based on the book, with Oprah Winfrey starring as Deborah Lacks, Henrietta Lacks’ daughter.

Several Lacks family members attended today’s event. “It is a proud day for the Lacks family. We have been working with Hopkins for many years now on events and projects that honor our grandmother,” said Jeri Lacks, granddaughter of Henrietta Lacks. “They are all meaningful, but this is the ultimate honor, one befitting of her role in advancing modern medicine.”

The building, which will adjoin the Berman Institute of Bioethics’ current home in Deering Hall will support programs that enhance participation and partnership with members of the community in research that can benefit the community, as well as extend the opportunities to further study and promote research ethics and community engagement in research through an expansion of the Berman Institute and its work.

The story portrayed in The Immortal Life of Henrietta Lackspoints to several important bioethical issues, including informed consent, medical records privacy, and communication with tissue donors and research participants.

“The story of Henrietta Lacks has encouraged us all to examine, discuss and wrestle with difficult issues that are at the foundation of the ethics of research, and must inform our relationships with the individuals and communities that are part of that research,” said Jeffrey Kahn, director of the Johns Hopkins University Berman Institute of Bioethics. “As a result, students, faculty and the entire research community at Johns Hopkins and around the world do their work with a greater sensitivity to these critical issues.”

In 2013, Johns Hopkins worked with members of the Lacks family and the National Institutes of Health (NIH) to help broker an agreement that requires scientists to receive permission to use Henrietta Lacks’ genetic blueprint in NIH-funded research.

The NIH committee tasked with overseeing the use of HeLa cells now includes two members of the Lacks family. The medical research community has also made significant strides in improving research practices, in part thanks to the lessons learned from Henrietta Lacks’ story.

“It has been an honor for me to work with the Lacks family on how we can recognize the contribution of Henrietta Lacks to medical research and the community. Their willingness to focus on the positive impact of the HeLa cells has been inspiring to me. The Henrietta Lacks story has led many researchers to rededicate themselves to working more closely with patients,” said Daniel E. Ford, vice dean for clinical investigation in the school of medicine. “The new building will be a hub for the community engagement and collaboration program of the NIH-supported Institute for Clinical and Translational Research.”

Groundbreaking on the building that will be named for Henrietta Lacks is scheduled for 2020 with an anticipated completion in 2022.

To learn more about Henrietta Lacks and the wide-ranging impact of HeLa cells on medical research,

please visit:www.hopkinsmedicine.org/henriettalacks.

Michelle Huckaby Lewis, MD, JD

Dr. Lewis received a BA degree in English and History from Stanford University before earning her JD degree from Vanderbilt University School of Law. After law school, she worked on Capitol Hill as a Legislative Assistant for Congressman Bob Clement from Tennessee. While working on Capitol Hill, she was appointed to the White Task Force on Health Care Reform during the Clinton Administration. She served on work groups related to Health Insurance Reform and Medical Malpractice Reform. Dr. Lewis then attended Tulane University School of Medicine and received her MD degree. She completed a residency in Pediatrics at the David Geffen School of Medicine at UCLA. She completed the Robert Wood Johnson Clinical Scholars Program at Johns Hopkins University and the Greenwall Fellowship Program in Bioethics and Health Policy at Johns Hopkins University and Georgetown University.

Leslie Meltzer Henry, JD, PhD

Professor Henry provides expert commentary for federal and local agencies, organizations, and the media. She has served as a bioethics consultant to the Department of Defense and has presented before panels of the Department of Health and Human Services, the Food and Drug Administration (FDA), and the National Institutes of Health Bioethics Advisory Committee. Professor Henry has provided written commentary for the Mid-Atlantic Ethics Committee Network, and she has been quoted in media outlets including the Atlantic, the Wall Street Journal, CNN, ABC, NPR, the Chronicle of Higher Education, Forbes, and the Baltimore Sun.

Professor Henry is a co-investigator on a project focused on addressing the ethical and legal challenges of conducting research with pregnant women during public health emergencies, like the Zika crisis, where there is an urgent need to attend to the health needs of pregnant women and their offspring.  She is also a member of PHASES, a research team aiming to develop ethically and legally acceptable strategies for conducting research about HIV treatment and prevention during pregnancy.

Prior to joining the faculty, Professor Henry completed a post-doctoral fellowship in bioethics and health policy at Johns Hopkins School of Public Health and Georgetown Law Center, clerked for the Honorable Judith Rogers of the U.S. Court of Appeals for the District of Columbia Circuit, was a fellow in the National Institutes of Health’s Office of Human Subjects Research, and was founder and Editor-in-Chief of the Yale Journal of Health Policy, Law, and Ethics.

Mark T. Hughes, MD, MA

In addition to his work in ethics, Dr. Hughes is co-developer and associate editor of the Internet Learning Center, an Internet-based curriculum utilized by medical residency programs across the nation. From 2005 to 2009, he was a facilitator in the course Curriculum Development in the Longitudinal Johns Hopkins Bayview Faculty Development Program, and he is co-editor of the book “Curriculum Development for Medical Education,” now in its third edition. Dr. Hughes previously served as a core faculty member in the Florence R. Sabin College in the School of Medicine. He has been an associate editor for the Journal of General Internal Medicine and was coordinator of the End-of-Life Interest Group for the Society of General Internal Medicine..