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WHO grants ethics approval for use of experimental Ebola drug - Zmapp

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The World Health Organization declared Tuesday that it's ethical to use unproven Ebola drugs and vaccines in the outbreak in West Africa provided the right conditions are met.

"In the particular circumstances of this outbreak and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention," the agency said in a statement.

The panel said "more detailed analysis and discussion" are needed to decide how to achieve fair distribution in communities and among countries, since there is an extremely limited supply of the experimental drugs and vaccines.

The statement from the UN health agency came amid a worldwide debate over the medical ethics surrounding the Ebola outbreak. However the agency sidestepped the key questions of who should get the limited drugs and how that should be decided.

WHO says 1,013 people have died so far in the Ebola outbreak in West Africa and authorities have recorded 1,848 suspected or confirmed cases.

Two Americans and reportedly a Spanish priest have gotten an experimental Ebola treatment never tested in humans and two more Ebola treatments were said to be on their way to treat two doctors in Liberia. ZMapp, a cocktail of monoclonal antibodies, was developed in part at the Canadian National Microbiology Laboratory in Winnipeg.

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who.int - August 12, 2014

Ethical considerations for use of unregistered interventions for Ebola viral disease (EVD)

Summary of the panel discussion

West Africa is experiencing the largest, most severe and most complex outbreak of Ebola virus disease in history. Ebola outbreaks can be contained using available interventions like early detection and isolation, contact tracing and monitoring, and adherence to rigorous procedures of infection control. However, a specific treatment or vaccine would be a potent asset to counter the virus.

Over the past decade, research efforts have been invested into developing drugs and vaccines for Ebola virus disease. Some of these have shown promising results in the laboratory, but they have not yet been evaluated for safety and efficacy in human beings. The large number of people affected by the 2014 west Africa outbreak, and the high case-fatality rate, have prompted calls to use investigational medical interventions to try to save the lives of patients and to curb the epidemic.

Therefore, on 11 August 2014, WHO convened a consultation to consider and assess the ethical implications for clinical decision-making of the potential use of unregistered interventions.

In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.

Ethical criteria must guide the provision of such interventions. These include transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community.

In order to understand the safety and efficacy of these interventions, the group advised that, if and when they are used to treat patients, there is a moral obligation to collect and share all data generated, including from treatments provided for ‘compassionate use’ (access to an unapproved drug outside of a clinical trial).

The group explored how the use of these interventions can be evaluated scientifically to ensure timely and accurate information about the safety and efficacy of these investigational interventions. There was unanimous agreement that there is a moral duty to also evaluate these interventions (for treatment or prevention) in the best possible clinical trials under the circumstances in order to definitively prove their safety and efficacy or provide evidence to stop their utilization. Ongoing evaluation should guide future interventions.

In addition to this advice, the panel identified areas that need more detailed analysis and discussion, such as:

  • ethical ways to gather data while striving to provide optimal care under the prevailing circumstances;
  • ethical criteria to prioritize the use of unregistered experimental therapies and vaccines;
  • ethical criteria for achieving fair distribution in communities and among countries, in the face of a growing number of possible new interventions, none of which is likely to meet demand in the short term.

A report of the meeting proceedings will be available to the public by 17 August 2014.

List of participants

Advisors
1 Prof Michael Selgelid Director of the Centre for Human Bioethics, Monash University Australia
2 Dr. Philippe Calain (chair) Unité de Recherche sur les Enjeux et Pratiques Humanitaires (UREPH), Médecins Sans Frontières Switzerland
3 Prof. Aisssatoue Toure Head of Immunology Department, Pasteur Institute, Dakar Senegal
4 Prof. Ross Upshur Canada Research Chair in Primary Care Research; Professor, Department of Family and Community Medicine and Dalla Lana School of Public Health, University of Toronto; former Director of the University of Toronto Joint Centre for Bioethics (2006-2011) Canada
5 Prof. Peter Smith Professor of Tropical Epidemiology, London School of Tropical Medicine and Hygiene United Kingdom
6 Dr. Helen Byomire Ndagije Head of the Drug Information Department in the Ugandan National Drug Authority (NDA) Uganda
7 Prof Jeremy Farrar Director, Wellcome Trust United Kingdom
8 Prof Ryuichi Ida Chair of National Bioethics Advisory Committee Japan Japan
9 Ms. Jeanine Thomas Patient Safety Champion United States of America
10 Dr. Juan Pablo Beca Professor, Bioethics Center at Universidad del Desarrollo Chile
11 Pr. Tariq Madani Professor of internal medicine and infectious diseases Saudi Arabia
12 Dr. Marion Danis Head, Sect. on Ethics & Health Policy (NIH) United States of America

Resource persons

Dr. Stephan Monroe, CDC, US-FDA
Prof. Luciana Borio, US-FDA
Dr. Frederick Hayden, U Virginia, USA
Dr. Daniel Baush, U.S. Naval Medical Research Unit No.6 Lima, Peru

Twelve Declarations of interest for advisors and four for resource persons were reviewed. No conflict of interest was declared by any of the advisors. Dr Fred Hayden, one of the resource persons, declared that “he and his University have received compensation for his time in reviewing one patent case regarding Zanamivir (GSK) and medicolegal cases involving fatal influenza and delayed use of Oseltamivir (Roche).” It was clarified with Dr Hayden that he had conducted the case reviews as a full faculty member and that he had not received any remuneration for them separate from his faculty. It shall be noted that the resource persons contributed their valuable technical expertise only when requested by the chair.

Media contact:

Gregory Hartl
WHO Department of Communications
Telephone: +41 22 791 44 58
Mobile: +41 79 203 67 15
E-mail: ***@***.***

http://www.who.int/mediacentre/news/statements/2014/ebola-ethical-review-summary/en/

By Stephanie Smith, Holly Yan and Jacque Wilson, CNN
updated 9:48 AM EDT, Tue August 12, 2014
 

(CNN) -- The first two doses of an experimental serum created to treat Ebola went to American missionaries.

Then the drug was sent to treat a Spanish priest.

The two Americans, Dr. Kent Brantly and Nancy Writebol, appear to be recovering. The priest, Miguel Pajares, died Tuesday morning.

That's the problem with experimental drugs that have never been tested in humans: No one knows if they'll work -- and if they do, in whom.

This week, the World Health Organization gathered a group of ethicists to decide whether untested medications and vaccines should be used in the current Ebola outbreak. As the death toll from the epidemic soared over 1,000, the WHO panel unanimously concluded it is ethical to offer medications to fight the Ebola virus, even if their effectiveness or adverse effects are unknown.

(READ COMPLETE ARTICLE)

(FULL REPORT - CLICK HERE - 12 page .PDF report)
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