Dr. Andre Kalil a leading Ebola doctor from Nebraska Medical Centre has confronted the University of Oxford's Jake Dunning who has helped run Ebola drug trials in Liberia and Sierra Leone at a World Health Organisation meeting in April saying, "We couldn't do this in US, you couldn't do it in the UK, so why do you think you can do it in Africa".
The issue at hand is that Oxford and some european groups are evaluating ebola drugs without using a comparison group of patients given a placebo. Randomly assigning patients to drugs or a placebo is the gold standard for testing whether drugs work or aren't causing any harm.
Dr. Dunning of Oxford University has however said in an interview that ''non randomized trials are ethical and valid. To do randomized (placebo) controlled trial would be unethical. However this means not only giving out unproven medicines but also the likelihood that the drugs effectiveness will never be proven''.
Deputy Director of the US National Institutes of Allergy and Infectious Diseases has a different view, he says its going to be hard to come up with conclusible answers outside of randomised controlled trial. It has thus not been possible to demonstrate the efficacy of any experimental intervention.
US officials and some European researchers believe that experimental drugs and vaccines should be given in West Africa only as part of a randomised controlled and double blind trial. This means patients would randomly be assigned to receive the experimental drug or placebo and that neither the doctor nor the patients would know who got what.
This method generally produces the fastest most compelling answers and avoids the possibility of doctors overlooking dangers of experimental drugs.
Wall Street Journal
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