Thursday, May 14, 2015

I am very disturbed by the situation regarding the conflict of principles between scientists (ourselves) and certain health officials in Europe concerning the conduct of randomized controlled clinical trials in the Ebola outbreak in West Africa. I am absolutely astounded by the lack of scientific rigor demonstrated by people like Jeremy Farrar the head of the Wellcome Trust and certain scientists at Oxford University including Peter Horby and Adrian Hill. I am also surprised that Peter Piot is also sharply criticizing any placebo-controlled trials particularly of drugs. We have considerable experience with HIV and in other arenas where the artificial show of compassion in a serious disease that results in wide distribution of unproven drugs leads to a double jeopardy of never proving that an intervention works or not, and more importantly misses the possibility that they are actually harming people. The British and as well as people at WHO and Doctors without Borders by taking somewhat of a self-righteous approach that any research done in the setting of an Ebola outbreak is unethical are actually hurting people. The Oxford group actually covered up that several patients given open access to Brincidofavir died and they never reported it. They said that the study was stopped because there were no more infections, when this was a blatant misrepresentation. There have been dueling criticisms in the press between our approach and theirs about this. A recent Wall Street Journal article by reporter Tom Burton analyzed this carefully and blasted the Europeans for giving out medicines in an open access manner while likely hurting people with drugs that have clear toxicity that have really no pre-clinical indication that they would work. In my mind Cliff Lane is a true hero in this as he is designed and implemented randomized controlled trials for vaccines in Liberia as well as controlled randomized trials without a placebo for certain drugs like ZMapp. I am terribly disappointed with Tom Frieden who continues to insist that you cannot do a randomized controlled trial of the vaccine in countries like Guinea because this would interfere with the public health effort of getting the epidemic down to zero. Clearly, as well-meaning as he may be, he does not have a clue about how to design or implement a clinical trial. Again I am really very disappointed with him, with the WHO, with the Wellcome Trust, and with individual characters such as Jeremy Farrar and Marie-Paule Kieny at WHO. They really should be ashamed of themselves.