Efficacy and safety data from use of unapproved Ebola virus treatments should be shared according to an expert panel convened by the World Health Organisation (WHO) this week.
The WHO issued the statement earlier today after meeting to discuss the ethics of using unapproved therapies and vaccines to try and halt the spread of Ebola viral disease in West Africa.
The organisation said: “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.”
It added that: “The large number of people affected by the 2014 West Africa outbreak, and the high case-fatality rate, has prompted calls to use investigational medical interventions to try to save the lives of patients and to curb the epidemic.”
So far only Mapp Biopharmaceutical’s ZMapp, an unapproved antibody cocktail, has been tired and - according to a Bloomberg - supplies of the drug have already been exhausted .
The use of other candidate treatments and vaccines is also being considered with products being developed by Tekmira and Sarepta garnering the most attention.
According to the WHO “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.
To understand the safety and efficacy of these interventions, the panel advised that, if unapproved drugs and vaccines are used “there is a moral obligation to collect and share all data generated, including from treatments provided for ‘compassionate use.”
All Ebola 'trials'
Quite how receptive regulators and the pharmaceutical industry will be to such open information exchange is unclear, but ongoing arguments relating to the publication of clinical trial do not bode well.
Campaigning group Alltrials says, predictably enough, that all trial data should be published. Drug industry organisations counter that making all data available is a disincentive to innovation that hands competitive advantage to rivals.
Whether the firms working to develop Ebola treatments and vaccines will be willing to put humanitarian concerns ahead of their competitive instincts and share data from the use of unapproved products remains to be seen.
The WHO panel – which is expected to publish its conclusions on August 17 – also said there is a moral duty to “evaluate these [unapproved] interventions 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.”