A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
-
August 6, 2014 - Some of the events that occurred today are very important. Lisa Hensley, an NIAID employee (Ph. D) is a NIAID scientist who reports to Peter Jahrling at Fort Detrick. She was in Liberia to give technical assistance. She had informed Cliff that her role in Samantha's Purse (SP) getting the zMapp antibodies for Dr. Brantley and Nancy Writebol was only peripheral and facilitating. Lisa has been called back by Cliff and returned from Liberia last night and Cliff Lane gathered a considerable amount of information from her. It appears that she has been much more active in assisting the people from SP in procuring the zMapp antibodies from Gary Kobinger of the Canadian Health Agency. In addition to just pointing the SP people in the right direction, she was actively involved in organizing an attempt to procure the antibodies and deliver them to the patients. The CDC was actively involved also in the person of Kevin DeCock who put Lisa in contact with SP. In addition, the United States Embassy in Monrovia, Liberia was very actively involved in this process. With regard to the latter the embassy provided a UN helicopter to take Lisa and the military attaché from the embassy to the border of Sierra Leone and Liberia to pick up the package of monoclonal antibodies. However, SP had already chartered their own helicopter and picked up the material themselves. Nonetheless, our prior determination and announcement to the media that the NIH as well as the federal government played only a minor role in the procurement of these antibodies is technically not correct. When I found out about this, I felt it was very important to alert HHS Secretary Sylvia Burwell. I briefed her on the fact that the original statement from the Department of Health and Human Services regarding the role of NIH was not technically correct. She agreed and indicated that we would have to let the White House know particularly the General Counsel. The reason why this is important is that technically speaking SP has broken the law by bringing in a drug from Sierra Leone to Liberia without the permission of the health officials of Liberia. In addition, there is also the issue of ethics in procuring a drug for one individual when there is very short supply. And so the question is asked how can one get drug for American doctors and health workers when hundreds of Africans are dying from the disease. We will have to face this issue in the press even though technically speaking NIH did not procure the drug. The appearance is that we at least assisted the SP in getting it. It is important to emphasize that Lisa Hensley was acting on her own accord without asking permission from any of her superiors and so she was really not representing the NIH. It appears now that this was what Sanjay Gupta of CNN was talking about when he told me by phone that he had e-mails that indicated that an NIH person was actively involved in procuring zMapp antibodies for SP and that the US Embassy was also involved and that he could not show me the e-mails since the person who gave them to him had a lawqyer who advised against it. I believe that the secret party who gave Sanjay the e-mails is SP who are now afraid that they have broken the law and are trying to say that the USG helped them and so how could it be wrong. It will be interesting to see how this all plays out. Billy Fischer from UNC visited NIH to help the Clinical Center get ready for the possibility of admitting Ebola patients since the CDC is sending 50 people to West Africa and there is the possibility that they may get infected and might need care. Billy spent time in Sierra Leone directly taking care of patients. He was great! Again, much press today → CBS Morning Show with Charlie Rose and Norah O'Donnell; NBC Channel 4 Local News; CNN with Jake Tapper. August 7. 2014 - Re-visit of part of the African Delegation that is visiting DC. Francis Collins and I and other IC Directors briefed them in Medical Board Room of the Clinicial Center at 11:15 AM. Present were Mali President Kweita and Zambia Vice president Guy Scott and his wife Charlotte. I presented information about NIAID activities relevant to their countries (Mali - malaria; Zambia - HIV, TB). Media frenzy continues with Gaza war and Ebola. Ebola dialogue now focusing on the ethics of distribution of scarce interventions during medical crisis. Triggered by the availability of zMapp for the 2 American patients. Press today CNN New Day; MSNBC with Ronan Farrow; CNN International; Sirius Radio (Fox) with Marc Siegel VYC Brian Lehrer
-
August 8, 2014 - Frenzy continues. Press includes WTOP Radio, WNYC Brian Lehrer Radio, Fox Business TV, NPR Los Angeles. Gaza + Ebola - now ISIS is taking over Iraq and the USA in now bombing their advance to a Kurdish city where American diplomats are holed up. The USA wants to avoid another Benghazi. Because of this the White House is not allowing any government people to go on Sunday AM TV and so I had to cancel invitation from This Week with George Stephanopoulos and "Face the Nation". White House is in the controlling the message mode.
-
August 8, 2014 - (Saturday) - Having daily Secretary and NIH (Collins) call. Issue is that we are trying to expedite going into phase 1 trials of interventions that have only been in pre-clinical. These include zMapp, the Canadian VSV vaccine, the VRC ChimpAd3 vaccine. Emory is making "side deals" with Mapp for zMapp and Canada for VSV to get pre-exposure prophylaxis for doctors at Emory. Potential problem is an "optics" problem in that USG is helping Westerners get interventions that Africans cannot get. This is all getting very intense and similar to the Anthrax issues from 2001. Sylvia is starting to see more clearly what I can do regarding leadership on the phone calls.
-
August 11, 2014 - The frenzy around Ebola still continues with the major issue being the ethics of getting experimental drugs to the two Americans, and most recently to a Spanish priest who was flown from West Africa to Madrid and who received the experimental zMapp cocktail of monoclonal antibodies. The media are pushing the story of favoritism towards the West and developed nations as opposed to the Africans who are suffering from the disease. They fail to understand that there is no evidence that zMapp actually works, and the fact is that there are only three doses left in the possession of the company that owns it, i.e. MAPP Biopharmaceuticals. Of note, the President of Liberia has contacted the White House to see if the United States can expedite either transfer of two sick Liberian doctors to the United States for care and/or obtain doses of zMapp for them. It is interesting that Larry Zeitlin, the CEO of MAPP Biopharmaceuticals, has contacted Cliff Lane telling Cliff that he wants to get rid of the three doses of zMapp that he has in his possession because of the pressure on him to distribute it to a number of people in Africa who need it. He does not want to be put in this ethically difficult position. He wants to give it to either WHO or MSF. However, he does not want the US government to react negatively to this. He wants to make sure that we do not criticize his giving the doses to another entity, thereby making them responsible for its distribution. We have been having a daily conference call including this past weekend on Saturday and Sunday with Sec. Sylvia Burwell to keep up with the rapidly evolving E bola situation. During that call yesterday (Sunday), Secretary Burwell suggested that since we helped the American doctors to get doses of zMapp that we might suggest to Larry Zeitlin that he give the doses to the Liberians. This would accomplish two goals: 1) it would allow President Obama to respond to the Liberian president, and; 2) it which show the world that we do not just favor Westerners, but that we are helping to make drugs available to Africans. We had a conference call yesterday (Sunday) with Canadian health authorities to inquire about the availability of their experimental VSV Ebola vaccine. On the call were our HHS team with me, Cliff Lane, Hilary Marston, Nicki Lurie, Dawn O'Connell (Sec. Burwell's Chief-of-Staff), Tom Frieden and CDC folks, Robin Robinson, Leslie Dasch (Counsellor to Burwell). On the Canadian side there was Gregory Taylor (Deputy Chief Public Health Officer), Judith Bosse (Assistant Deputy Minister, Infectious Diseases prevention and Control Branch), Theresa Tam (Branch Head, Health Security Infrastructure branch) and Supriya Sharma (Assoc. Assist. Deputy Minister, health Products and Food Branch). The Canadians are still in preclinical studies and have not yet gone into humans. There is an ongoing disagreement between me and Tom Frieden. Tom wants to give the vaccine to health workers in Africa even before it has gone into a phase 1 trial (I believe that he has been speaking with his CDC people who are preparing to go to Africa and are understandably concerned about their risk). I do not believe that Tom understands the clinical trial process since he says that we are "ethically obliged" to allow the healthcare workers to make the decision themselves about whether they are willing to take a potentially unsafe, potentially ineffective vaccine. If this were a drug to be given to a desperately ill patient, then that is one thing about going directly from preclinical to human treatment. However, this is a vaccine to be given to a healthy person. On the call with the Canadians, I pointed out our experience with the HIV vaccine which was effective in monkeys, but in humans it actually significantly increased the risk of acquisition of HIV infection. In order to expedite things Cliff Lane will organize a quick phase 1 trial at the NIH Clinical Center to test the safety of the Canadian vaccine. Once again, I have been all over the press. Last night I was on CNN with Jim Sciutto as well as on CNN International. Today I will do the Diane Rehm Show.
-
2014-08-12 00:00
Anthony S. Fauci
August 12, 2014 - We are having a daily (including Saturday and Sunday) conference call with Secretary Burwell and a separate call among NIHers with Francis Collins. Press interest in dying down somewhat (I was only on Colombian (Bogotá) radio and Czech Radio only. The issues are centering now around the ethics of using experimental drugs (we actually have none available) and vaccines (getting ready to go into Phase 1 with the NIH (VRC) Chimp Ad3 vector with Ebola env gene inserts) prior to proof of safety and efficacy. The Canadians also have 2 VSV Ebola vaccines. There is no more ZMapp left - 2 courses went to Brantley and Rightbol, 1course went to the Spanish priest who died, and 2 courses were sent to Liberia to treat 2 Liberian doctors who contracted Ebola caring for patients (President of Liberia appealed to President Obama. The USG put Liberia in touch with Larry Zeitlin and MAPP Biopharmaceuticals.
-
August 13, 2014 - My invited Perspective on Ebola came out online at 5:00 PM in the New England Journal of Medicine. Cliff Lane and I are trying to reconcile the need for data of safety and efficacy of the NIH vaccine and the need to get it to people who need it. We drew up a proposal for a Randomized Clinical Trial (RCT) to take place in the countries in Africa right after the Phase 1 here at the NIH. This would settle the ethics issue (randomization is "fair" and also would collect data to prove efficacy and safety. I geria following the will propose this at the next Secretary's call. The logistics of this will be difficult due to the lack of infrastructure in the 4 African countries. Did WBAI Radio in NYC and Al Jazeera TV today. Latest numbers for Ebola - 1900+ cases and 1050 deaths
-
August 14, 2014 - Things quieting down a bit in the press. Still struggling with ethics issues and clinical trials issues. Canada has "hot-dogged" by announcing that they are "donating" 400-800 doses of their vaccine for use in Africa. Of course, that is exactly where we will give it when we show that it is safe. Also Jeremy Farrar, the head of Welcome Trust is grandstanding a bit saying we must not just "sponge down the patients and let them die". Give me a break. Now WHO wants to use the Phase 1 doses of vaccine to vaccinate their people who are going to Africa. They want 200 doses to do a "phase 1 trial" in their staff. 200 doses is a product distribution program, not a phase 1 trial. Did CBS News and AP TV today.
-
August 15, 2014 - Went up to Philadelphia to see the White Coat Ceremony at the University of Pennsylvania Medical School where my daughter Megan is beginning her first year of medical school. Beautiful day and wonderful ceremony. We are so proud of Megan and hope that she will be happy. I know that she will do well having graduated summa cum laude from Columbia and then excelling in the Post-Bacc pre-med year at Hopkins.
-
August 16-19, 2014 - Media blitz stopped, but the epidemic still rages. The West African countries are instituting quarantines and border closings, which may slow down the epidemic, but there is the beginning of a humanitarian crisis to get food, water and supplies to the quarantined areas. Tom Frieden and I are working out how we can reconcile the issue discussed above about the balance of open access of vaccine following phase 1 versus the need to know by RCT whether the vaccine actually works and whether it might actually do harm, as per the Ad5 HIV vaccine enhancement of HIV acquisition in a former clinical trial a couple of years ago. The department was clearly concerned (Andrea Palm - chief-of-staff to Burwell- pissed me off on a conference call by acting annoyed with Tom and me in our discussions on the daily conference call) about the disagreement between Tom and me; however, Tom and I are now trying hard to work it out behind the scenes.