1) Access to experimental treatment, on a compassionate basis, given the severe spontaneous development of the disease (60% mortality). Who is given priority when administering treatment available in small quantities and under what conditions in the absence of human data? In addition, the ZMapp serum is developed by private pharmaceutical companies, which raises the issue of the partial or total waiver of intellectual property.
For WHO, several ethical principles should guide and direct its prescription including “the transparency of all aspects of care, informed consent, freedom of choice, confidentiality, respect for people, preservation of dignity and community involvement”. In this way, unknown information regarding therapeutic risks and effects should be explained as clearly as possible to the patient before a decision is made on their part.
2) The effectiveness and safety of treatment only tested in a laboratory on non-human primates, and then directly administered to two sick patients (with no possible comparison with healthy patients) given the health emergency at hand. The effectiveness of the ZMapp serum on both American patients can only be hypothesised. For example, they may be part of the 40% of patients who survive because of their health and nutrition prior to contamination.
WHO is currently looking into conditions to establish a research protocol in West Africa with all of the required rigour and methodology. Experts are mulling over available means in order to “scientifically evaluate the use of these interventions during the study to ensure the timely provision of accurate information on their safety and effectiveness”. And if this treatment is effective, how can access to care and follow-up for contaminated patients be assured in the long term?
These ethical issues recall those raised by AIDS and by diseases associated with poverty in general (Malaria, tuberculosis and HIV-AIDS), which Inserm are combating alongside the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) (French site), as well as the French National Alliance for Life Sciences and Health (AVIESAN).
experts from the Inserm Ethics Committee
are available to answer your questions (see “Researcher Contacts” Section).