Friday, March 27, 2015

Today was a very interesting day. The patient is wide-awake all of his chemistry numbers are normal. I spent a full hour in the room with him speaking with him about a variety of subjects. He clearly is in somewhat of a hypomanic state. He continually speaks and in a pressured manner. We now know that he has a depressive disorder on meds and this hypomanic state could be a combination of our inadvertently taking him off his psychotropic meds (although his ketamine, etc.) would substitute for that) and his developing a manic phase to his underlying depression as a result of the amazing stress of his illness. As far as his organ system function goes he is doing very well except for some residual weakness and conjunctivitis in his right eye. We hope that this is not Ebola uveitis. He will be seen by ophthalmology tomorrow. Cliff Lane and I had a very disturbing conversation today with Yves Levy (President of INSERM) who is in Paris. It is becoming very clear that Marie-Paule Kieny (WHO) for political reasons in order to show that the World Health Organization was doing something for Ebola has been pushing a ring vaccination trial in Guinea together with the Norwegians. Cliff and I (mostly the hard work of Cliff) are working with the Guineans to expand our Liberian RCT vaccine trial to Guinea where there are still infections going on. WHO and the Norwegians do not want us to start the RCT in Guinea and are leaking to the press that we are trying to “derail” their trial. In fact, the Norwegian government has complained to our State department about our trying to start the RCT in Guinea. The French (Levy and Delfraissy) agree with Cliff and I that the ring vaccination in Guineas will not be able to determine efficacy. Of note, both Levy and Delfraissy are on the scientific advisory board for that trial even though they do not believe that it is scientifically sound. I gently chastised Yves on the phone telling him that he should resign from the board. Bottom line is that he told Cliff and me that this is politically sensitive since Marie-Paule is pushing the ring trial purely for “political reasons” in trying to show that WHO is “doing something and leading something”. For some inexplicable reason, she has gotten the Norwegians (John-Arne…) to buy into this. Yves knows as do Cliff and I that Marie-Paule is close to being incompetent and knows nothing about the research method of clinical trials. First, there should not be a ring vaccination since ring approach assumes that the vaccine works. We are trying to determine scientifically if it works. Everyone knows that an RCT is the “gold standard” to determine safety and efficacy. We are convinced that the Guineans would go along with the best scientific approach. Yet, WHO is trying to block the initiation of our trial until they have finished their trial that everyone with any sense knows that the ring trial will be inadequate. This is “politics” at its worst. Marie-Paule should really be fired. If we were the type to leak this to the press such as to Jon Cohen or Kai Kupferschmidt from Science, this would be a scandal for WHO. Finally, in the arena of incompetence and politics, the “Favipiravir study” in Guinea done by MSF and the French is claiming to show that it works (see above) even though there is no control group except an “historical control”. Now the French are telling us that the Guineas are making Favi part of their standard of care (SOC). Thus, is we want to extend out ZMapp study to Guinea (where there are infections), then we would not be able to compare SOV versus SOC + ZMapp as we are doing in the USA and Liberia, and now Sierra Leone. The FDA and we feel that FAVI should not be SOC and if fact might be harmful. We will try to work with the health and political types in Guinea to get a proper ZMapp study going. Truly amazing politics, ignorance, and LACK of INTEGRITY on the part of people including people in WHO. MSF just does not know much about doing clinical research, even though they are “heroes” for their clinical care work.