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PostPosted: Tue Aug 12, 2014 5:59 am 
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WHO panel concludes it is ethical to treat Ebola cases with unapproved drugs.

http://who.int/mediacentre/news/stateme ... ummary/en/

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PostPosted: Tue Aug 12, 2014 6:00 am 
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Ethical considerations for use of unregistered interventions for Ebola viral disease (EVD)

Summary of the panel discussion

WHO statement
12 August 2014

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: hartlg@who.int

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PostPosted: Tue Aug 12, 2014 6:07 am 
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12 August 2014 Last updated at 05:35 ET
Ethical to use experimental Ebola drugs, says WHO

WHO: Experimental drugs may be offered in some cases

The World Health Organization has determined it is ethical to provide experimental treatments to patients infected with the Ebola virus.

The panel of medical experts met in Geneva to discuss the merits of using untested drugs.

Some 1,013 people have died from the virus in West Africa.

The move came as Liberia announced it was set to receive an experimental drug, Zmapp, after requests made to the US government.

The WHO said it had been persuaded to recommend the move because of the scale of the outbreak and large number of deaths.

Where experimental treatments are used there must be informed consent and the results of the treatment collected and shared, the WHO said.

Map showing Ebola outbreaks since 1976
In a statement, it added: "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."

Last week the WHO declared the Ebola outbreak was a global health emergency.

line
What drugs exist currently ?

There a handful of drugs that have been shown to work well in animals.

One is Zmapp - the drug requested by the Liberian government. This contains a cocktail of antibodies which attack proteins on the surface of the virus.

Only one experimental drug has moved into early human testing. Known as TKM-Ebola this interrupts the genetic code of the virus and prevents it from making disease causing proteins.

The drug was tested on healthy human volunteers at the beginning of 2014 but the American medicines regulator asked for further safety information. The drug company says human trials may soon resume.

Vaccines to protect against acquiring the disease have also been shown to work in primates. American authorities are considering fast-tracking their development and say they could be in use in 2016.

But experts say ultimately the only way to be sure a drug or vaccine is effective is to see if it works in countries affected by Ebola.

line
Meanwhile, the Liberian Government said experimental drugs will be brought into the country later this week - although manufacturer Mapp Biopharmaceutical warned supplies are limited.

Zmapp has been used on two US aid workers who have shown signs of improvement. A Roman Catholic priest, infected with Ebola in Liberia, who died after returning home to Spain is also thought to have been given the drug.

However, the drug has only been tested on monkeys and has not yet been evaluated for safety in humans.

'Hard place'
There is no cure for Ebola, which has infected at least 1,779 people since the outbreak was first reported in Guinea in February.

The Liberian government said it was aware of the risks associated with Zmapp, but the alternative was to allow many more people to die.

"The alternative for not testing this is death, a certain death," Information Minister Lewis Brown told the BBC.

"This is not even the rock and the hard place for us.

"We think those who have been infected should be given the chance to have that tested on them if they give their consent to do so.

"We know there may be risks associated with it," the minister added, "but choosing a risk and choosing dying I am sure many would prefer to see that risk happen".

Ebola's initial flu-like symptoms can lead to external haemorrhaging from areas like eyes and gums, and internal bleeding which can lead to organ failure. Patients have a better chance of survival if they receive early treatment.

Symptoms include high fever, bleeding and central nervous system damage
Fatality rate can reach 90% - but the current outbreak is about 55%
Incubation period is two to 21 days
There is no vaccine or cure
Supportive care such as rehydrating patients who have diarrhoea and vomiting can help recovery
Fruit bats are considered to be virus' natural host

http://www.bbc.com/news/world-africa-28754160

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PostPosted: Tue Aug 12, 2014 8:13 am 
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3 ZMapp treatment courses to Liberia.

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PostPosted: Tue Aug 12, 2014 8:20 am 
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WHO may act as intermediary to connect governments with suppliers, but will not determine who gets what.

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PostPosted: Tue Aug 12, 2014 8:23 am 
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vaccines and therapeutics for different populations

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PostPosted: Tue Aug 12, 2014 8:25 am 
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WHO intermediate help due in part to size of outbreak affecting multiple countries

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PostPosted: Tue Aug 12, 2014 8:30 am 
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safety in different populations (HIV, pregnant, children) unknown

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PostPosted: Tue Aug 12, 2014 8:31 am 
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no approved drug is a market failure (expense of clinical trials / small market)

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PostPosted: Tue Aug 12, 2014 8:35 am 
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3 dose course is based on neutralization activity

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