Ebola and ethics: Grappling in “the hot zone” and beyond Dr. Nancy Walton Associate Professor and Director of eLearning, Ryerson University Chair, REB, Women’s College Hospital Toronto Image: SMH.com.au

Source: Andre Carrilho/Andrew Carrilho

December 2013: First cases of mysterious hemorrhagic fever noted in Guinea. March: WHO notified of EVD outbreak March 31: First death due to EVD in Liberia. May 26: First cases and deaths reported in Sierra Leone, traced back to traditional healer who had been treating EVD patients in Guinea. June 11: Sierra Leone closes borders with Guinea and Liberia.

June 17: EVD reported in Monrovia, capital of Liberia. June 21: MSF calls outbreak “totally out of control”. July 25: First case in Freetown, the capital of Sierra Leone, reported. July 30: Schools close in Liberia. July 31: The Peace Corps evacuates all volunteers from Sierra Leone, Guinea and Liberia.

August 2: Dr. Kent Brantly is evacuated to the US for treatment. August 4: World Bank pledges up to 200 million dollars for EVD relief. August 5: Nancy Writebol, a US missionary, is airlifted to the US for treatment. August 8: With over 1000 dead, the W. African EVD outbreak is declared a Public Health Emergency of International Concern by the WHO.

Between August 1 and 31, there are 2100 new cases identified and 1000 deaths. August 15: MSF likens outbreak to “war” August 20: Military fires tear gas and live rounds at citizens attempting to break quarantine in Monrovia. September 3: WHO Director- General warns that the outbreak is “complex” and “racing ahead of efforts”. September 8: WHO confirms EVD in 14 out of 15 Liberian counties.

October 8: Thomas Eric Duncan dies of EVD in US. October 17: US President Obama appoints an “Ebola Czar” criticized for having no public health experience. October 24: US enacts mandatory quarantine for health care workers arriving from West Africa. First EVD death reported in Mali. October 25: Number of EVD cases officially exceeds 10,000.

December 4: In Sierra Leone, workers dump bodies in the street in protest. December 12: Christmas and New Year’s canceled in Sierra Leone. January 3: Confirmed # of deaths reaches January 21: Sierra Leone, Guinea and Liberia report lowest weekly infection rates (< 100) since June. January 30: Asymptomatic cases reported, suggesting viral mutation. February: Trials of 2 vaccines begins in Monrovia. April 20: Liberia declared EDV- free.

EVD BY THE NUMBERS 3 most affected countries (Sierra Leone, Guinea, Liberia): Approximately 26,000 total cases confirmed, probable or suspected with 11,000 deaths. In Nigeria, Senegal, Spain, UK, US and Mali: 35 cases with 3 deaths Guinea and Sierra Leone continue to report new cases 37 two weeks ago, 33 last week

THE PERFECT CONDITIONS FOR RAPID SPREAD Largest outbreak of a filovirus Fragile health infrastructure weakened by years of conflict, neglect Open borders and frequent travel Rapid spread to densely populated cities Poorly coordinated and delayed response Virus strain with high mortality Misunderstandings about transmission Lack of trust in government and authority

Most previous outbreaks were limited in size and geographic spread, typically affecting a few hundred persons, in remote rural areas without spread to urban centres. Largest previous outbreak occurred in Uganda in 2000 with 425 cases over 3 months. Controlled through “rigorous application of interventions to minimize further transmission — delivered through the local health care system, with support from international partners.” WHO Ebola Response Team, NEJM, Oct 2014

GEOGRAPHIC CHALLENGES

Image: mic.com Interest in Ebola over time [Based on an analysis from Google Trends]

July: Two Samaritan’s Purse workers, Nancy Writebol and Kent Brantly, both US citizens, become infected with Ebola, are returned home and are treated with ZMapp. A third dose is given to a Spanish priest who later died. Thousands of West African patients are left untreated.

The question of whether untested therapies should be used on people – and vulnerable people – and if so, who should have first access to these untested therapies – is only one of the many ethical questions raised in this outbreak. -Annas, 2014

Research ethics Ethical principles Public health ethics Media ethics Professional ethics Scarce resources Priority setting Personal autonomy Duty to care

RESEARCH ETHICS: QUESTIONS How much focus should we be putting on “who gets the drug?” How do we justify giving an untested but promising drug to some and not others, specifically to American aid workers and not to West Africans? Should we simply provide as many experimental drugs as possible to West Africa? Is it ethically sound to pass over the normal drug-testing protocols in the context of EVD?

Is it ethical to use unregistered interventions that have shown promising results in the laboratory and in animal models:  for treatment of those infected?  for post-exposure prophylaxis?  for pre-exposure prophylaxis? If so, then:  What criteria should guide the choice of intervention?  Who should receive priority?

MORAL OBLIGATIONS  to provide experimental therapies.  to ensure capacity to collect and share data. Guiding principles: Transparency, trust, fair distribution in the face of scarcity, promotion of cosmopolitan solidarity, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community.

CRITICAL PERSPECTIVES Focus perceived to be on provision of small # of untested therapies in the context of a widespread public health disaster. Panel membership included only one physician from West Africa (Senegal) and no one else “on the ground”. MSF highly critical of WHO response and timing. “Meetings happened. Action didn’t.” Marie-Christine Ferir (Emergency Coordinator, MSF)

Serious challenges Priority setting with scarce resources Health human resources. Basic protection of health care workers. Defining fairness of distribution. Calculating the potential risk of harm. Obtaining free and informed consent. Ensuring confidentiality.

SERIOUS CHALLENGES Ever-present risk of detracting attention and resources away from the efficient implementation of clinical care and continuing care, infection prevention and outbreak control, contact tracing and follow-up, awareness building and education.

CONSENT AND FREEDOM OF CHOICE Tension, mistrust Critically ill patients in isolation, often forced Patient to clinician ratio Barriers to communication Lack of choice Respect for autonomy Voluntary nature of participation

Prior to 1989, Liberia generated 400 megawatts of electricity. 15 years of war resulting in a quarter of a million deaths. Monrovia is a city of over a million people surviving on 25 megawatts of diesel-generated power. Liberia uses less electricity in one year than a typical American football stadium uses in one season. -Paul Farmer

ETHICS AND PUBLIC HEALTH: QUESTIONS How do we reconcile efforts to evaluate experimental agents with established public health interventions to treat patients and reduce spread of disease? How do we balance the individual perspective with the public health perspective? Where should we direct efforts and limited resources?

Individual perspective Focus on clinical care and respect for autonomy. Beneficence: rescue from “potentially avoidable” deaths Non-maleficence: minimize potential risk of harm from untested therapies and vaccines Respect for autonomy: free and informed consent, freedom of choice. Emphasis on distributive justice and fairness. Public health perspective Focus on identifying and targeting key individuals and populations. Limits on autonomy and resources. Utility, impact: benefit beyond the individual. Interdependence, solidarity: consider impact on community trust. Effectiveness: carefully consider the likelihood of obtaining useful research data. Emphasis on procedural justice and fair process. Political and logistical considerations, community acceptance and lack of community trust, few choices and minimal resources, the need to manage expectations of both clinical care and research efforts.

DUTY TO CARE Context: high fatality, high risk of transmissibility, absence of proper PPE Lack of safe working environments and resources. Potential failure of duty to care

DUTY TO CARE Some argue that duty to care should be viewed as collective, rather than individual. Occurring within an institutional and societal context. Should not be about personal choice of HCWs or an appeal to individual morality. Must imply protection from institutions and support from society at large. -Bensimon et al 2007

What is the duty of the health care provider when faced with potentially elevated personal risk of harm?

“Why did they get the drugs?” Special moral obligation to those who are doing the most risky, altruistic volunteer work – supererogatory - deserve help when they are in need. Principle of reciprocity. Without a healthy group of workers to provide care, other inevitable problems are created. When treatments are scarce and risks are high, focus on those who can benefit most.

“I was called a fraud, a hipster, a hero –the truth is I am none of those things. I’m just someone who answered a call for help and was lucky enough to survive” -Craig Spencer in a NEJM essay

RESTRICTING PERSONAL AUTONONMY Quarantine: “Freedom from” or “freedom to” Privacy and confidentiality of Ebola patients’ personal information Air travel bans and mandatory screening

ONE YEAR LATER: A LONG LIST Already-strained social safety net. Health and public services depleted. Dramatic drop in use of health services. Predicted increases in deaths due to malaria, childbirth, AIDS. Economic disruptions due to restrictions on gathering and travel. Severely depressed agricultural sector. Marked decrease in exports, imports and tourism. Orphaned and displaced children. Abandoned education for an estimated 5 million children between ages 3 and 17. Increased severity of the impact upon women. Survivors stigmatized and isolated, living with chronic conditions, no personal belongings, not able to work: They are ”starting from scratch”.

One year later: Criticisms of international response.

“Public health preparedness requires ethics preparedness. We need to be prepared, for example, to communication early and often during an Ebola epidemic – drawing upon the best scientific evidence…” Amy Guttman, PhD Chair, Presidential Commission for the Study of Bioethical Issues

One year later: Priorities Continued support of and push for well- designed vaccine and therapy trials. Continued work on feasible contextual research ethics frameworks for outbreaks and emergencies.

One year later: Most importantly Rebuilding of local health systems and community trust. Rigorous disease surveillance, high- efficiency lab testing, early warning systems, community-supported research. Establishment of a well coordinated, well- funded global response.

One year later: Priorities Re-establishment of strong partnerships between international aid and local communities. Better coordination between donors, development partners and local communities with focus on real needs. Economic recovery, debt relief, re-establishment of commerce, trade and agriculture. Victim and survivor services, services for women and children, with a focus on recovery.

Lessons for us, here and now?  Expand the conversation  Frame the issues within broader ethical contexts  Recognize our moral obligations beyond our committees and institutions. Image: dec.uk.org