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STORY: GENEVA / EBOLA EXPERIMENTAL INTERVENTIONS
TRT: 2.14
SOURCE: WHO
RESTRICTIONS: NONE
LANGUAGE: ENGLISH / NATS
DATELINE: 14 NOVEMBER 2014, GENEVA SWITZERLAND / FILE
1. Pan left, from WHO headquarters to car on driving down road
2. SOUNDBITE (English) Dr. Martin Friede, Scientist, Department of Public Health Innovation and Intellectual Property, World Health Organization (WHO):
“Over the last two days we have had a meeting of high level scientists, experts in the Ebola virus, virologists, developers of drugs, pharmacologists, social scientists and we have reviewed the data around the drugs that are currently being proposed for treating Ebola.”
3. Close up, WHO banner
4. SOUNDBITE (English) Dr. Martin Friede, Scientist, Department of Public Health Innovation and Intellectual Property, World Health Organization (WHO):
“There are a wide number of drugs which have been tested in the laboratory which have been shown to have no activity whatsoever. And WHO will be putting a list of these drugs up on the website. I would like to point out that there is one drug, Lamivudine, which has been used in several of the countries to treat the patients and this has been used without any evidence whatsoever and the scientists reviewed the data and found that this drug has no activity against the virus whatsoever and therefore there is no justification for using it to treat Ebola.”
5. Wide shot, entrance to the WHO headquarters
6. SOUNDBITE (English) Dr. Martin Friede, Scientist, Department of Public Health Innovation and Intellectual Property, World Health Organization (WHO):
“First of all we discussed blood and clearly blood and blood derived products from patients that have recovered, these are clearly very promising and have been prioritized for evaluation. We still don’t know if blood from convalescent patients or the blood, the plasma, the immunoglobulins, we don't know if these actually work. So we need to find out if these products work, so these will be going into clinical trials very shortly.”
7. Close up, WHO banner
8. SOUNDBITE (English) Dr. Martin Friede, Scientist, Department of Public Health Innovation and Intellectual Property, World Health Organization (WHO):
“There are drugs for which we have a lot of data to suggest that they may be, have some utility, but these drugs are not readily available. These are novel drugs and then we have got drugs which are available, but for which we have much less data to suggest they would be of utility. So clinical trials will be beginning shortly on two of these drugs, which is Brincidofivir and Favipiravir to see if these drugs are safe and if they are efficacious against the virus and there are a number of other drugs which were proposed but for which the clinical trials still needs some discussion.”
9. Wide shot, exterior WHO headquarters
Following the emergence of Ebola virus disease (EVD) as a severe public health emergency for which no effective therapeutic or prophylactic interventions are available, the scientific community has proposed numerous experimental interventions, including: vaccines; convalescent blood and plasma; and medicines. None of these interventions have been evaluated for efficacy against EVD and therefore clinical studies to assess their safety and efficacy are required.
To facilitate and accelerate the appropriate clinical testing and generation of quality data of potential therapeutic interventions for EVD, WHO convened a meeting of the Scientific and Technical Advisory Committee for Ebola Experimental Interventions (STAC-EE) in Geneva, on 11-12 November 2014. The meeting was attended by experts in Ebola virus, preclinical and clinical testing, pharmacologists, sociologists, public health experts and regulators, as well as representatives from countries in West Africa.
Dr. Martin Friede, Scientist, Department of Public Health Innovation and Intellectual Property, World Health Organization (WHO):
“Over the last two days we have had a meeting of high level scientists, experts in the Ebola virus, virologists, developers of drugs, pharmacologists, social scientists and we have reviewed the data around the drugs that are currently being proposed for treating Ebola.”
STAC-EE reviewed the data on disease progression and the effect of some experimental products on 18 patients who were evacuated from West Africa to well-resourced facilities in other countries. Resulting data did not permit evaluation of efficacy of these interventions, and the comparatively high survival rate observed in these patients may be due to a variety of factors including the high standard of care they received.
SOUNDBITE (English) Dr. Martin Friede, Scientist, Department of Public Health Innovation and Intellectual Property, World Health Organization (WHO):
“There are a wide number of drugs which have been tested in the laboratory which have been shown to have no activity whatsoever. And WHO will be putting a list of these drugs up on the website. I would like to point out that there is one drug, Lamivudine, which has been used in several of the countries to treat the patients and this has been used without any evidence whatsoever and the scientists reviewed the data and found that this drug has no activity against the virus whatsoever and therefore there is no justification for using it to treat Ebola.”
The Committee was informed of clinical trials of convalescent whole blood (CWB) and convalescent plasma (CP) that are ready to start in two affected countries, and are in planning stages in one, as well as of efforts by the international community to accelerate access to these therapies through capacity building for the national blood transfusion services.
The study in Guinea, organized by a consortium from Belgium, France, Guinea, and the United Kingdom, will evaluate CWB first and switch to CP once supplies become available. An additional study will evaluate CP only. Studies being planned in Sierra Leone will evaluate CP, but also make provision for use of CWB under compassionate use.
SOUNDBITE (English) Dr. Martin Friede, Scientist, Department of Public Health Innovation and Intellectual Property, World Health Organization (WHO):
“First of all we discussed blood and clearly blood and blood derived products from patients that have recovered, these are clearly very promising and have been prioritized for evaluation. We still don’t know if blood from convalescent patients or the blood, the plasma, the immunoglobulins, we don't know if these actually work. So we need to find out if these products work, so these will be going into clinical trials very shortly.”
Noting that the standard of care in Ebola affected countries varies between different treatment centres and even in the same centres over time while standard of care is being established, it was agreed that clinical trials should only be conducted in facilities able to provide consistently good standard of care. The number of such sites in West Africa, capable of providing such care and with suitable infrastructure to conduct clinical trials, is limited. Indeed, there have been far more proposals of products to be tested than availability of sites in which they could be tested. It was therefore imperative that STAC-EE prioritize the products for testing, mindful of time pressure and to avoid wastage of resources.
SOUNDBITE (English) Dr. Martin Friede, Scientist, Department of Public Health Innovation and Intellectual Property, World Health Organization (WHO):
“There are drugs for which we have a lot of data to suggest that they may be, have some utility, but these drugs are not readily available. These are novel drugs and then we have got drugs which are available, but for which we have much less data to suggest they would be of utility. So clinical trials will be beginning shortly on two of these drugs, which is Brincidofivir and Favipiravir to see if these drugs are safe and if they are efficacious against the virus and there are a number of other drugs which were proposed but for which the clinical trials still needs some discussion.”
Collecting clinical data under the biosafety conditions required when treating Ebola necessitates careful consideration of the minimum data that should be collected, and since trials may be across multiple sites ideally such data collection forms should be harmonised. One minimal clinical data collection form was presented which will be used by several of the groups planning clinical trials. Other groups indicated a preference to develop a shorter and simpler form, but which would use several of the same data fields. These forms should be able to permit data pooling at a future date.
