The blog of the Presidential Commission for the Study of Bioethical Issues

Back Live for Day 2 of the Bioethics Commission Meeting in D.C.

We are back live and blogging in Washington, D.C. for day 2 of the 20th public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission).

The Bioethics Commission is continuing the discussion initiated at its November meeting in Salt Lake City focusing on issues arising at home and abroad from U.S. engagement in the global response to the current Ebola epidemic. Members today also resume consideration of ethical issues associated with neuroscience research and the application of neuroscience findings, as requested by President Obama.
You can follow the proceedings of the Bioethics Commission’s meeting here at this blog, and on the live webcast. The webcast and transcripts from the meeting will be archived and available following the meeting at www.bioethics.gov.

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Amnesia and Other Side Effects of Epidemics

If there is one medical condition that commonly occurs at the culmination of many infectious disease epidemics it is “amnesia.”

That was the message from Howard Markel, M.D., Ph.D., the George E. Wantz Distinguished Professor of the History of Medicine at the University of Michigan. He looked to previous fights against infectious diseases over the last 200 years to help the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) process the many lessons to be learned from the recent Ebola epidemic.

Markel said his fear is that precious little will be learned, or that what has been learned will quickly be forgotten.

“The most common final end to a pandemic is what I call profound amnesia,” he said. “SARS? What’s that? We are not yet at ‘Ebola? What’s that?’ But I guarantee you we will be there. And that’s the real problem.”

The Commission is grappling with the U.S. engagement in the global response to the current Ebola epidemic, and Thursday afternoon it sought insights from historical, sociological, and legal perspectives.

For the recent history of the fight against Ebola, the panel turned to Unni Karunakara, Dr.PH, a Senior Fellow at Yale University’s Jackson Institute for Global Affairs. Karunakara was involved in some of the early fights against Ebola during his time with Médecins Sans Frontières (Doctors Without Borders or MSF), where he last served as International President.

Karunakara said the confusion and suspicion that accompanied his early experiences confronting Ebola outbreaks in Africa quickly taught him that there is one thing that will always undermine the effectiveness of the effort.

“Ebola allows no time for mistrust,” he said. “Speed is of absolute importance in an outbreak response.”

Karunakara said MSF has learned that lesson well — for example, it now makes sure Ebola patients under its care can directly be observed from a safe distance by their relatives. That way, he explained, there is quite literally, transparency. But he said mistrust quickly became endemic in the recent Ebola outbreak when early on in the response authorities contemplated quarantines and enacted various restrictions on movement.

“We know that coercive policies are remarkably counter-productive,” Karunakara said. “Checkpoints and roadblocks meant to limit and control movement became a disincentive to seeking care. Fear of being quarantined has made people less forthright about having been in West Africa.”

Dorothy E. Roberts, J.D., the George A. Weiss University Professor of Law & Sociology University of Pennsylvania, believes some of the mistrust and suspicion surrounding the U.S. reaction to the Ebola epidemic stems from the fact that the disease tends to be viewed through the lens of racial stereotypes.

“The two things Americans associated with Ebola the most was Africa and fear,” she said. “The extent to which fear outweighed the scientific evidence of risk was determined by racial concepts and stereotypes and assumptions.”

Roberts said the racial view of disease has led many to think of Ebola as a disease of black people.

“There is a long history in the United States of understanding disease in racial terms and racial differences in terms of disease,” she said.

James W. Wagner, Ph.D., the Commission’s Vice Chair, wryly noted that the panel’s observations painted a bleak picture.

“What we have been hearing from you three is that the life cycle of an epidemic is to begin with denial and neglect and to end with amnesia,” he said. “And the middle is marked with disparities and human rights restrictions and misinformation.”

The Bioethics Commission is expected to deliberate possible recommendations tomorrow morning on the second day of its public meeting.

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Experiencing Ebola: First-Person Perspectives from the Diaspora and Health Care Workers

Among the many unfortunate outcomes of the recent Ebola outbreak is how public reaction played out in the affected communities, both in the countries themselves and also in the western African diaspora in the U.S.

As the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) continued its review of U.S. engagement in the global response to the current Ebola epidemic, it considered the experience of people who were quickly swept up in the tumult.

Oretha Bestman-Yates, who immigrated to the United States from Liberia in 1987 and now serves as president of the Staten Island (New York) Liberian Community Association, said Liberians in this country — even those who had been here for years — suddenly found themselves subject to suspicion and discrimination.

“I was directly hit by the stigmatization,” she said. “I even lost my job because I visited Liberia in July and my son, who was proud to call himself Liberian-American, now does not want to be associated with anything from Liberia. We were targeted by our neighbors…As you boarded a train or ferry people actually stood away from you because of your accent.”

Chernor Bah, Youth Engagement Officer of A World at School and Chair of the Youth Advocacy Group at the Global Education First Initiative, discussed the epidemic from the perspective of communities in western Africa. Bah is a former child refugee from Sierra Leone and has connections through non-profits to all three countries affected by the epidemic.

He said there were unfortunate aspects of the international response that fed fears and paranoia in the affected countries that the Ebola infections were caused by some type of conspiracy. Bah said one response that was particularly jarring was the decision by certain countries to ban any flights from Sierra Leone and Liberia.

“That created a sense of isolation and also a sense of helplessness,” he said. “It allowed conspiracy theories to fester and it took so much time for the counter narratives to take root.”

A similar sense of isolation and stigmatization also affected U.S. health care workers who have worked the Ebola wards of western Africa. Patricia Henwood, Director of Global Health Initiatives in the Department of Emergency Medicine at the Hospital of the University of Pennsylvania, has served on two Ebola-related medical missions to Liberia. She spoke to the Commission the day after her 21 day isolation period from her most recent mission.

Henwood noted the surreal experience of working in the intense environs of Ebola treatment centers, “quietly crying in our facemasks and goggles while holding the hand of children as they draw their last breath,” and then returning to a growing wave of suspicion, inconsistent policies and calls for quarantines.

“At times it felt more of a challenge to manage the return to the U.S. than to do the Ebola work in West Africa,” she said. “We were touted as heroes when we worked in West Africa, but treated as pariahs when we returned home.”

The stories from the front-lines of the epidemic clearly moved members of the Commission. Christine Grady, R.N., Ph.D., Chief of the Department of Bioethics at the National Institutes of Health Clinical Center, teared up as she thanked the panel. “I just want to say I think you are all heroes and I wanted to shout out to the nurses because I am a nurse.”

Commission Chair Amy Gutmann said she has been impressed by how returning health care workers have been so “rationally passionate and passionately rational.”

As the fears in the United States appear to be dying down, Bah said he now finds it jarring how a disease that had so consumed American media and politicians just a few months ago is now largely ignored in the U.S., even as cases continue in Sierra Leone.

“Yesterday we had 21 cases in Sierra Leone,” he said. “We still have schools that have been closed down for a year. People are still dying every day, but we are speaking about Ebola as if it is in the past tense.”

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Learning the Lessons from Ebola to Inform Future Fights

As part of its review of  U.S. engagement in the global response to the current Ebola epidemic, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) sought insights from a panel of experts with decades of experience on the front lines of fighting infectious diseases.

Peter Hotez, M.D., Ph.D., Dean of the National School of Tropical Medicine at Baylor College of Medicine and President of the Sabin Vaccine Institute, said he hopes the Ebola epidemic will prompt health officials in the U.S. and around the world to get ready for what he believes could be even more disruptive and deadly encounters with infectious disease in the near future.

“It would be nice if for once the world could be proactive,” he said.

For example, Hotez said he has been advising the State Department and the White House that “the next shoe about to drop is in the Middle East and North Africa.”

“In ISIS-occupied Syria and Iraq we are already seeing refugees pouring across the border into Jordan, Lebanon, and Turkey. We are seeing rabies, huge amounts of Leishmaniasis. We are going to see Middle East Respiratory Syndrome. We have got to build capacity for the next big thing that is going to happen.”

Helene Gayle, President and CEO of CARE USA, observed that it has been the enduring frustration of public health veterans that preventative measures often are not widely embraced and thus struggle for attention and funding.

“Having spent most of my life trying to get people excited by non-events, which is what prevention is, we have to be realistic,” she said. “It is much more difficult to get people to care about something that they are preventing versus something they can change.”

Gayle said the lesson from her work at CARE is that if the U.S. wants to be more effective in its efforts to deal with threats like Ebola, it needs to establish trust and relationships in the affected countries.

“In our work in Sierra Leone and Liberia around Ebola, it has been with communities we have been working with for years,” she said. “We work in micro-finance, in agriculture productivity, so they already trusted CARE and our partners. We were not just there for Ebola. We were not just there for this disease that America now cares about.”

William Foege, M.D., M.P.H., is a Senior Fellow for Health Policy at the Carter Center, a Senior Fellow in the Global Health Program at the Bill and Melinda Gates Foundation, and an Emeritus Presidential Distinguished Professor of International Health at Emory University. Foege was deeply involved in the battle against smallpox in the 1970s, and served as Director of the Centers for Disease Control and Prevention (CDC) from 1977-1983. He said among the lessons from his many years of experience, he learned that it’s very hard to get people to focus on problems affecting the poor. But he believes Ebola may be a prime opportunity to generate a new level of support for fighting the diseases of poverty and conflict and it should not be wasted.

“We should make the most out of Ebola,” he said. “Despite the fact that there are bigger problems, I always tell students that one of our jobs is to tie the fears of the rich to the needs of the poor. And Ebola has become a fear of the rich and we should use that to the maximum.”

Next up: The Bioethics Commission turns its attention to how the Ebola crisis has played out in Western African immigrant communities in the United States and among health care workers returning from working in affected countries.

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In Rush to Develop Ebola Therapies, a Debate Over Placebo Control

This morning the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) resumed consideration of U.S. engagement in the global response to the current Ebola epidemic by examining ethical issues that arise when conducting research during a public health emergency.

As experts move to accelerate development of drugs and vaccines against Ebola, a debate has emerged over whether these therapies should be evaluated with the placebo randomized control approach. This type of research involves clinical trials in which one group of volunteers receives the actual vaccine or drug candidate and another group receives a placebo.

Many clinicians consider the placebo-control approach to be the gold standard for determining the efficacy of a new treatment. But tension in western Africa today involves how scientists and policy makers should prioritize humanitarian and scientific concerns as they address both the immediate crisis and seek evidence that can be applied to future outbreaks.

Clement A. Adebamowo, B.M., Ch.B., F.W.A.C.S., F.A.C.S., Sc.D., a Professor of Epidemiology and Public Health at the University of Maryland School of Medicine, told members of the Bioethics Commission that the placebo-control approach provides very strong evidence. But Adebamowo, who was closely involved with Nigeria’s Ebola response as chair of Nigeria’s National Health Research Ethics Committee, said Nigerian health authorities have concluded there are instances in which other approaches may be warranted.

“We believe that these things should not be taken as doctrinaire positions,” he said. “That is why the Nigerian ethics committee issued the guidance statement saying we are going allow the use of therapies that have not completed the standard clinical trial development pathway in the context of this epidemic and share the data with all so we can rapidly evaluate the efficacy of these interventions.”

Luciana Borio, M.D., Assistant Commissioner for Counterterrorism Policy and Director of the Office of Counterterrorism and Emerging Threats at the U.S. Food and Drug Administration (FDA), said that there is an ethical case to be made for conducting a placebo-control trial even in the midst of a major disease outbreak like the Ebola epidemic in western Africa. While some have questioned the ethics of giving a placebo to research subjects at high risk of being exposed to Ebola, Borio said that one could argue that conducting a trial without a placebo control is unethical if it is not going to determine treatment efficacy.

“In the case of Ebola, (such a trial) would be scientifically invalid and a scientifically invalid study by definition cannot be ethical,” she said.

She said that western African countries have been very receptive to clinical trials with a placebo control and that the recent Ebola vaccine trial initiated in Liberia, which includes a placebo, has attracted a large number of volunteers.

“We have taken position that the best way forward is an adaptive randomized control trial,” she said. “We think that is the best way to protect patient safety now. We know that new Ebola outbreaks will occur and now is the time to do this right.”

There are other issues to consider, said Nancy Kass, Sc.D., the Phoebe R. Berman Professor of Bioethics and Public Health in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health and Director for Public Health at the Berman Institute of Bioethics.

Kass acknowledged that for a vaccine trial, without a placebo control, “how else can we learn that the vaccines work?” But she said for evaluating treatments, there could be other options.

“Ethics is often about thinking of a creative third option,” she said, “and that often requires getting a lot of people with a lot of different expertise in the same room who can think creatively.”

For example, Kass said that one option could be to hold a small pilot study with 40 patients where all get the treatment to see if the experimental treatment is overwhelmingly effective, a “home-run drug.”

“So if out of 40 people, 38 get up and walk away, you don’t need a placebo,” she said. “But if 38 people did not walk out, you actually have a lot more ethical justification for introducing a placebo.”

Next up: The Commission seeks perspective on the Ebola response from veterans of past fights against infectious disease outbreaks.

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Bioethics Commission Sharpens Focus on Ebola Challenges

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) is conducting an in-depth review of U.S. engagement in the global response to the current Ebola epidemic.

In her opening remarks, Amy Gutmann, Ph.D., chair of the Bioethics Commission, noted that the panel is seeking insights into three critical issues: the ethics of placebo-control trials in the context of public health emergencies; the ethics of U.S. public policies that restrict association or movement; and the ethical considerations relevant to collecting and storing biospecimens during a public health emergency and sharing them for future research.

“I believe that the overarching theme of all of these discussions is that major infectious disease epidemics are a matter of U.S. concern for both ethical and prudential reasons,” Gutmann said. “We are obligated to engage in such devastating outbreaks from a global justice perspective, and also—considering the ability of infectious diseases to travel in our interconnected world—it is prudent for us as a country to address epidemics at their source.”

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Bioethics Commission, Live from Washington, D.C.

We are live and blogging in Washington D.C. for the 20th public meeting of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission). The Bioethics Commission is meeting today, February 5, from 9 a.m. to 5:30 p.m. ET, and tomorrow, February 6, from 9 a.m. until 11:30 a.m. ET.

At this meeting, the Bioethics Commission will continue considering the implications of a public health emergency response, with a focus on the current Ebola epidemic, a topic first discussed at the Commission’s Nov. 2014 public meeting. Tomorrow, members will resume consideration of ethical issues associated with neuroscience research and the application of neuroscience findings, as requested by President Obama. They also will discuss recommendations associated with the Ebola response.

You can follow the proceedings of the Bioethics Commission’s meeting here at this blog, and on the live webcast. The webcast and transcripts from the meeting will be archived and available following the meeting at www.bioethics.gov.

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The Bioethics Commission’s Meeting 20 Milestone

This February will mark an important milestone for the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission); the Bioethics Commission will hold its 20th public meeting. The 2-day meeting will be held February 5-6, 2015, in Washington, D.C. Since President Obama issued the Executive Order establishing the Commission on November 24, 2009, it has convened quarterly each year in order to publically discuss and deliberate various bioethical topics. As a Federal Advisory Committee, the Commission conducts all meetings and deliberations in public.

The Bioethics Commission held its first public meeting July 8-9, 2010 in Washington, D.C. to discuss its first topic, synthetic biology and the ethics of new technologies. The Commission has since covered a wide breadth of topics including privacy and genomic sequencing, ethical treatment of research participants, ethical duties of returning incidental findings, and the ethical conduct of neuroscience research. This year Commission meetings have focused on neuroscience; bioethics education and deliberation; and public health emergency response, with a focus on the current Ebola virus disease (EVD) epidemic.

During its quarterly meetings, Commission members hear from experts relevant to the topic being deliberated. After meeting 20, the Commission will have heard from more than 200 speakers. These speakers have come from across the U.S. and the world, and represent a variety of disciplines and interests including science, technology, law, medicine, and affected communities. Presentations from these experts provide Commission members with background information and lay the foundation for their deliberations. The roundtable discussions that occur during the public meetings serve to inform the recommendations published in each report. After meeting 20, the Commission will have engaged in more than 135 hours of public discussion and deliberation to inform its recommendations.

The Bioethics Commission does not rely on one ethical framework to guide its deliberations and recommendations. Instead, the Commission often draws upon broader ethical principles to inform its conversations and resulting analyses and recommendations. Some key bioethical principles that have run throughout many of the Commission’s reports include beneficence, democratic deliberation, respect for persons, as well as justice and fairness.

At meeting 20 the Bioethics Commission will continue to discuss the ethical considerations of neuroscience research, as well as public health emergency response in the context of the current EVD epidemic. Details, including the meeting location and agenda, will be posted to Bioethics.gov on the Meeting page. Meetings are always open to the public, and guests are encouraged to attend. For those unable to attend, all meetings are webcast live and archived at Bioethics.gov/meetings. See you February 5-6, 2015!

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Why the Bioethics Commission Asks for Public Comment

Public comments play a critical role in the Presidential Commission for the Study of Bioethical Issues’ (Bioethics Commission) deliberations. Public input is essential for processing and analyzing challenging bioethical topics.

The Bioethics Commission is currently seeking public comment on the ethical considerations of U.S. public health emergency response with a focus on the current Ebola virus disease (EVD) epidemic. At its meeting on November 6, 2014, the Bioethics Commission began its consideration of this topic, and the Commission plans to continue this discussion at its next public meeting February 5-6, 2015 in Washington, D.C. Before making any recommendations, the Commission will consult with a broad range of individuals and groups.

The collection of a wide variety of public comments is one aspect of the Bioethics Commission’s practice of democratic deliberation. The Commission’s call for public comments serves as a way for the public to provide their input on current topics. Public comment comes from a variety of sources, including but not limited to individuals, scientists, organizations representing affected communities, and federal agencies. In addition, Commission meetings are always open to the public, and attendees are encouraged to submit written comments at meetings.

The Bioethics Commission has issued requests for comments for each topic it has examined since its start. For its current request, the Commission is considering three specific areas related to the current EVD epidemic: the ethical foundations of U.S. policies that restrict association or movement; the ethics of placebo-controlled trials in the context of public health emergencies; and the ethical considerations relevant to collecting and storing biospecimens during a public health emergency and sharing them for future research.

For more information, and to view the request for comments as it appears in the Federal Register, visit the Bioethics Commission’s website. Please email comments by February 6, 2015 to info@bioethics.gov.

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Using the Bioethics Commission’s Pedagogical Materials on Informed Consent and Incidental Findings to Engage Students Undergoing Personalized Genetic Testing

Recently, some U.S. educational institutions have used personalized genetic testing (PGT) as a pedagogical tool for teaching human genetics, allowing students to generate real-world experiences with technology relevant to course content. In a recent article published in the Journal of Microbiology & Biology Education, Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) staff members Tenny Zhang and Misti Ault Anderson assert that PGT also can be an effective tool for incorporating ethics into the biology classroom. Experiencing PGT first-hand represents a chance for students to reflect upon and discuss the many facets of genetic testing, including the interpretation, limitations, and potential impacts on individuals and society.

PGT in the educational setting provides an opportunity to integrate ethical considerations into the science classroom since genetic testing can raise a number of ethical concerns, including ensuring informed consent, protecting privacy, and promoting accessibility, among others. Integrating discussion about ethics into biology courses that offer PGT can help students to make direct and personal connections between the science learned in class and related bioethical challenges, and encourage consideration of the broader ethical implications of genetic testing.

While it has not taken a position on the use of PGT in the classroom itself, the Bioethics Commission has consistently emphasized in its work the need for ethics education across various disciplines, educational levels, and settings. As part of its ongoing effort to support bioethics education, the Bioethics Commission developed educational materials to facilitate ethics integration.

The Bioethics Commission’s topic-based modules, which are designed to be flexible to support multiple approaches to implementation and can be adapted into existing curricula in various educational settings, can provide a helpful resource to instructors using PGT in classrooms. Report-specific modules about informed consent in the context of whole genome sequencing (Informed Consent in Privacy and Progress) and incidental findings (Informed Consent in Anticipate and Communicate) are relevant to PGT and might help encourage students to consider the ethical complexities of genetic testing. The Conversation Series primer on incidental findings for consumers helps them to understand what incidental findings might arise in the direct-to-consumer (DTC) context and prepares them to ask the DTC provider relevant and important questions.

The full article by Zhang and Anderson, “Personalized Genetic Testing as a Tool for Integrating Ethics Instruction into Biology Courses,” can be read here.

For more information on all of the Bioethics Commission’s educational efforts, please watch the video, Promoting and Providing Materials for Bioethics Education, here.

All Bioethics Commission pedagogical materials are publicly accessible at www.bioethics.gov.

The Bioethics Commission encourages feedback on its materials at education@bioethics.gov.

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This is a space for the members and staff of the Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

Learn more about the Presidential Commission for the Study of Bioethical Issues.

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