Thursday, October 23, 2014

Today was another hectic day regarding the possibility of implementing a randomized controlled trial for a Ebola vaccine. As mentioned several times above there is a nefarious attempt on the part of Jeremy Farrar of the Wellcome Trust to derail plans for an RCT of vaccine in Liberia. Cliff Lane has known him for a long time from when he was in Vietnam with the Pasteur Institute. Jeremy feels that we should do open access for distribution of vaccines particularly to healthcare workers without doing a controlled trial. Jeremy has been a self-promoter and in my mind a hypocritical advocate for fairness in global health. He completely does not get the fact that if we widely distribute a vaccine to a black African country we run the risk of never knowing if it works and possibly having a paradoxical harmful effect similar to what we saw in the STEP trial of an HIV vaccine where the trial looked good in phase 1 following good animal data and when we went into a double-blind, placebo-controlled trial, we found out that the people who received the vaccine had a 41% greater chance of getting infected with HIV. If the same happened with Ebola this would be a catastrophe. Yet the WHO, mostly in the form of Marie-Paule Kieny, are acting in an extraordinarily unscientific way, even going so far as to say that a randomized controlled trial is unethical. In fact, we feel that a wide distribution of an unproven and potentially harmful vaccine would in fact be unethical. In addition, they want to give it to the healthcare workers on open access and then possibly do a randomized controlled trial on the rest of the people at risk such as family members. I cannot imagine how they do not realize that this in and of itself is unethical and violates ethical equipoise. There is a big struggle going on with the USA led by Cliff Lane the FDA, and Glaxo Smith Kline to be able to do a randomized controlled trial to as quickly as possible determine efficacy so that we can ultimately distribute the vaccine to the people who need it. WHO, who was been wrong on almost everything they have done with this epidemic, is arguing that we really should distribute the vaccine according to how they want to do it. We already have designed a phase 2/3 trial and it is ready to go. We have buy-in from the Ministry of Health of Liberia. Glaxo Smith Kline is on board. Yet WHO wants to be deeply involved in deciding how we do it vaccine trial. There is a