Experimental Ebola Drugs Face Ethical Questions Amid Clinical Trials.

Experimental Ebola Drugs Face Ethical Questions Amid Clinical Trials.

Nature (11/12, Hayden) explores the ethical concerns surrounding testing for experimental Ebola treatments. According to Nature, two trials taking place in Guinea and Liberia will announce this week whether or not some trial participants will receive a placebo during the testing for ZMapp, a treatment for Ebola. On November 11, NIH held a conference of researchers to consider US clinical trials, while on the same day in Geneva, Switzerland, the WHO held a similar meeting. The WHO concluded that because “standard of care” available in Africa is insufficient to keep patients alive, no control should be used. With plasma trials, controls can be selected among those patients for whom no serum match is available. Clifford Lane, deputy director for clinical research and special projects at NIAID said about the trials, “The idea that there’s no need for randomized, controlled trials presupposes that the drugs have zero side effects, that they are efficacious, and that there’s no substantial variability from patient to patient,” adding, “I don’t think any of that is true.”

        NPR (11/11, Harris) reports in its “Goats and Soda” blog that the meeting in Geneva will also consider how to design the trials to best meet ethical considerations and patient health. The WHO’s Martin Friede cautioned that placebo trials are met with skepticism in West Africa and notes other designs that can meet rigorous scientific challenges, saying, “This can be done through historical records, it can be through comparing what’s being done in other sites.” Friede added, “What we do not want are trials that are conducted where, at the end of the study, we are unable to say whether the drug is safe or not or whether the drug is effective or not.”

        OSU Scientist Develops Promising Ebola Treatment. The Oregonian (11/11, Terry) reports that a scientist at Oregon State University has developed a potential Ebola treatment. Patrick Iversen, the head scientist on the project, said initial trials were very promising, and that “If the epidemic lasts, I’m pretty sure we will use the drug (in Africa).” Sarepta Therapeutics, the firm behind this treatment, was in attendance at the NIH meeting on Tuesday. Sarepta has 20 courses of treatment available now and in two-three months, could have ten times that amount on hand.