Via Nature News & Comment, a September report by Declan Butler: Ebola drug trials set to begin amid crisis. Excerpt:
William Pooley, a nurse from the United Kingdom who caught Ebola while treating patients in Sierra Leone, is the latest person in the current outbreak to receive the experimental drug ZMapp. Yet there is still no evidence that the drug, or any of the other treatments under development for Ebola, are safe or effective in people.
To change this state of affairs, the World Health Organization (WHO) is this week convening a major meeting to prioritize the most promising experimental Ebola drugs and vaccines, and to discuss how clinical studies can best be carried out in the chaotic environment of a deadly disease epidemic.
Although the drug’s manufacturer Mapp Biopharmaceutical of San Diego, California, has given out doses of ZMapp to seven people so far, this was authorized on a case-by-case, ‘compassionate use’ basis. No drugs or vaccines for Ebola have been approved by regulators.
The first phase of clinical trials, to test for a product’s safety, is usually carried out in healthy volunteers in facilities with sophisticated clinical-trials infrastructure. But an unusual combination of factors — the difficulty of implementing public-health measures to control the disease’s spread in the affected countries, the huge social and economic disruption that it is causing and the fact that the current outbreak kills about 53% of the people it infects — makes this crisis an exception.
Last month, an expert panel convened by the WHO concluded unanimously that it is ethical to use unapproved drugs and vaccines in this outbreak, provided that every effort is made to gather the best scientific data on their safety and efficacy. And on 4–5 September, 150 Ebola scientists, industry executives, clinical-trials experts, ethicists and regulatory officials are due to meet at the WHO’s headquarters in Geneva, Switzerland, to identify and prioritize the most promising products for use in clinical trials.