Monday, 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.