Tuesday, September 9, 2014

There is a considerable disagreement going on about the role of randomized placebo-controlled clinical trials (RCTs) in determining the efficacy and true safety of the GSK/NIH chimp adenovirus vaccine. The British in the form of Jeremy Farrar Head of Wellcome Trust as well as the WHO (Marie-Paule Kieny) seem to want to distribute the vaccine outside of a clinical trial. They are responding to what is an emotional need to get some intervention out there even though we have experience to indicate that the worst thing that can happen is the widespread application of the vaccine or other interventions that either do not work or actually paradoxically make things worse as we have seen with the HIV vaccine experience where a HIV vaccine that looked good in preclinical as well as in phase 1 actually increased the risk among the vaccinees of HIV acquisition by up to 41%. This is the worst thing that could happen in the Ebola situation. Cliff Lane and I are trying hard to strike a delicate balance between making our vaccine available following phase 1 trials which have just started here at NIH and continuing to pursue the scientific path of determining if it works and is safe without a paradoxical effect of harming. Had an extraordinary conversation with Tom Frieden tonight. Tom had been at a National Security Council meeting at the White House today hoping that he would guess an indication that they would be many more resources to address the Ebola outbreak. He had been secretive about the meeting; I can understand that since I have been at many WH meetings where they wanted to keep things secret until they made a decision. He obviously was very disappointed after the meeting since he called me on my cell phone in my car as I was driving home late tonight from the NIH. Tom was more animated and distressed that I have ever seen him. I knew this to be the case since he used foul language (“Fucking ….”) and I have never heard Tom used foul language before. He was completely frustrated by the fact that his meeting with the National Security Council and representatives from USAID as well as the secretary's office indicated to him that nothing new was going to happen and this whole idea about getting the military involved was really more PR than anything else. He also found out that Cliff Lane in his role as a member of the Defense Medical Board will actually be meeting with Gen. Martin E. Dempsey, Chairman of the Joint Chiefs of Staff, tomorrow (Wednesday, September 10) and he essentially implored me emotionally to get Cliff to emphasize to the Chairmen (General Dempsey) that it is absolutely essential that we have a major military presence in approaching the epidemic in West Africa. We need plans, thousands of beds, trained personnel, Command and control, etc. Without these assets, Tom feels that the epidemic will remain out of control and spread to many countries in West Africa and throughout Africa as well as to other countries outside of the African continent. He also indicated to me that some people who he did not name were telling the military that they need not get involved since vaccines and ZMapp will soon end the epidemic before they even get their planes in the air. This is obviously complete nonsense and Tom knows it. He emphasized the need to please tell Cliff Lane to tell the Joint Chiefs of Staff that this is not the case. Finally, Tom indicated to me that the military are afraid of getting infected because they hear that so many healthcare workers are getting infected. He implored me to tell Cliff that with proper personal protective equipment there really has been no infections among individuals from MSF. This is turning into a very interesting scenario we will see what happens tomorrow on September 10 when Cliff actually meets with the Joint Chiefs of Staff. I assured Tom that Cliff and I strongly feel the way he does and we both have been pushing hard behind the scenes to get the military involved. In fact, I have been talking with Mike Gerson (as has Francis Collins) about approaching John Podesta in the WH to get the POTUS to agree to military intervention. I spoke again with Mike Gerson about this today. After my call with Tom Frieden, I called Cliff and related the story. I did not need to encourage Cliff to say these things since I knew that he would. I got back to Tom and told him that things were on track with Cliff for tomorrow and Tom felt better and thanked me for my help. In addition today I had conversations on the phone with Paul Farmer who was very willing to set up more facilities in West Africa via Partners in Health (they are already in Liberia with Raj Punjabi) together with Jim Kim of the World Bank so that we can do some good clinical work as well as clinical research. Paul indicated that I did wonders with PEPFAR, and that he would like to partner with me to do some good with Ebola.