A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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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.
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March 28, 2015 - Unusually cold, clear day for Spring in Bethesda. Around 28 in the AM. Patient continues to do well. Still hypomanic and not getting any sleep. We are reluctant to medicate him too much due to concern about prolonged QTC. Cliff and I continued our conversation by phone with Yves Levy in Paris and us in Cliff's conference Room on the 4th Floor of the ACRF in Building 10. Yves now agrees with everything that I indicated in note from March 27 (above). He will work to help get the RCT done in Guinea and we will work together with the RCT therapy trial in that the French will try to do the SOC + FAVI Versus SOC+FAVI+ZMAPP and we will do SOC versusSOC + ZMapp.
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March 29, 2015 - Sat up about 45 minutes with today (Sunday - sunny but very cold for end of March in DC - 23 degrees F). Continues to improve markedly. Moving all extremities well. Left arm issue resolving. Conjunctivitis improving. Sitting up and eating progressive diet. Speaking every day with his mother and friend who come up from Houston where he lives. We are considering changing status to "Fair". Of note, we still get very weak PCR signal from sweat, saliva and urine one or more of which alternates on different days from weakly positive to negative. This will have implication for his release and for broad policy given that the Liberian woman got infected (and died) from her sex partner who was an Ebola patient in the 100+ day of recovery. Interesting to see how this will all play out.
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March 30, 2015 - getting much better with strength and neuro approaching normal. Still too weak to get out of bed, but can stand for 1 minute. Eating voraciously; maybe too much since he has been having Gatorade, pizza, ham sandwiches and actually vomited. After this he felt fine. Have upgraded his condition from "serious" to "fair". PM CT in blood is negative (40 CT) Also, urine, saliva is negative. Interesting issue is that axillary sweat is persistently positive (~32 CT). Cliff and I will meet with the US Ambassador to Guinea at the State department tomorrow to try and work out the issue with performing an RCT vaccine trial in Guinea. Marie-Paule Kieny is truly a fraud and acting purely on political motives. The WHO does not want us or anyone to start an RCT in Sierra Leone with ZMapp until they finish their TKM-EBOV open access trial (treat one ETU) and compare it historically to another ETU. This stance even though the pre-clinical data on ZMapp are infinitely more promising than those from TKM-EBOV. They would rather finish their study and delay the start of a trial with a promising drug just because they "politically" want to be a player. Also, in the vein of everybody wants to be somebody, various groups including Welcome Trust, and even the BMGF want to start the Global Research Collaboration for Infectious Diseases Preparedness (GloPID-R) - a network of funding organizations in the area of infectious Diseases research. Obviously, we are the major player and these other organizations have little to ad, but they want a network that would require us to go to endless meetings and give them a say of what the direction of the research would be. Ugh! Been there, done that with the HIV Vaccine Enterprise, etc.
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2015-03-31 00:00
Anthony S. Fauci
March 31, 2015 - continues to improve with increased strength. Need to figure out way to get him back to Dallas where his parents live. He lives in Houston. Technically, since he is now PCR negative X2, he can fly commercial; however, the optics will be bad - people get hysterical if they find out he is an ex-Ebola patient. And so wrote to Paul Farmer to see if PIH will pay for a charter for him to fly from DC to Dallas. Cliff and I went down to State Department to meet with US Ambassador to Guinea - Alexander Mark Laskaris to get his help in smoothing the way for us to do the RCT for the Ebola vaccine in Guinea since Guinea is where the infections are and the Norwegians and WHO clearly do not want us to do the trial there (see above). Laskaris totally gets that WHO are the "bad" guys and have lost all credibilityand he will support us. Chris and I took out Denise and jack to Fiola Mare restaurant in Georgetown for jack's 80th birthday. Below is final communication between Harold Varmus in his last official day as NCI Director and me. He has been a dear friend as NIH Director and over the past 5 years as NCI Director:
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April 1, 2015 - continues marked improvement. Sitting up in cardiac chair; off full PPE and now on contact isolation only. He walked with help from the hot zone room to the contact isolation room. even played an April Fool's joke on Rick Davey by feigning severe illness when Rick came in the room. claimed that he did not know who Rick was or who Nurse Megan was. Parents delighted. Tom Burton of Wall Street Journal is digging into the story about the conduct of Welcome trust, WHO and Chimerix (brincidofavir). He is a smart reporter and is catching on to the scandalous conduct of these parties.
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April 2, 2015 - Gave Q and A-type lecture on 7th floor of Humphrey Building hosted by Bill Schultz the General Counsel of HHS. Big crowd of all the OGC people from the department. I told the story (via questions from Bill) about my dealings with multiple administrations. After the session 12:30 PM to 1:30 PM, Sylvia Burwell had asked to see me in her office. She had just come back from the White House. She profusely thanked me and the NIH team for all we are doing with and with the vaccine trials. Apparently Tom Frieden had told her that he did not want to CDC to "move into Guinea" because of the instability. A bit puzzling since the CDC is already there. We still plan to extend the RCT vaccine trial to Guinea. review from the NY Times up and walking. Unfortunately, despite 3 negative CT's for blood, he reverted (after one negative) to positive in his left axilla sweat/skin.
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April 3, 2015 - doing great. Dilemma is the persistently weakly + PCR of axillary sweat. Has resting tachycardia that might be subclinical cardiomyopathy. Has been seen in other recovered patients in the USA (Emory/Nebraska). Gregg Gonsalves (old ACT-UP and TAG) who is now a Ph.D. student at Yale has brought to NIH (7A-24) a few (three) Yale students to interview me on a piece that they are writing on the issues with unnecessary quarantine of people working with Ebola. They are interviewing me because of the stand that I took in opposition of Gov. Cuomo and Christie a few months ago.
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April 5, 2015 (Easter Sunday) - CBS ran their Sunday AM special profile of me in a Q and A with Scott Simon (NPR). It turned out magnificently. I received scores and scores of e-mails of congratulations, many-fold more than even when I did 2 "Full Ginsberg's" a few months ago. E-mails from as diverse people as Gary Edson, Josh Bolton, Lisa Monaco (NSC), Catherine and Wayne Reynolds, old friends from NY Hospital, etc., etc. Will have to make decision about doing a single PCR on axilla and if negative, then stop testing rather than looking for 2 consecutive negatives. This is unchartered waters, since he has already had multiple negative blood PCRs.