Diary Prequel Package — page 412

since we (NIH) are the sponsors and we are liable. Nonetheless, GSK feels that although the PREP act would protect us and indirectly them, they feel that in international courts GSK (even though they are not the sponsors of the trial) could be sued given the sensitive nature of the situation (African countries, instability in the countries, brand new vaccine platform for them -Cad3 vector -, accelerated development with questions regarding lot consistency (because of the fast pace of development). This would be terrible if the trials are stalled because of this. I have phone call today with Moncef Slaoui, Chairmen of GSK for Global Vaccines. Also, despite our conclusions from meeting on Nov. 11 (see above) the Oxford/Wellcome Trust people are working with MSF to start "open label" trials with various therapeutics without a control arm. What the hell is going on here? I am very disappointed in the Brits, especially the Wellcome Trust and Oxford people who clearly are grandstanding. Call with Moncef Slaoui went well. Reasonable discussion. I stated that the USG could never give "global indemnification" since it would invite frivolous lawsuits. Moncef felt the same about our providing insurance for them since it would also invite lawsuits. We agreed upon some form of a process that provides for limited liability and cpas on settlements. I will follow-up with summary e-mail to Moncef with copy to Ron Klain with who I spoke tonight and relayed to him the conversation with Moncef. Ron is flexible, but said that we cannot "guarantee" anything to Moncef, but we will proceed in good faith to find a solution. Nov. 15, 2014 - Sierra Leone surgeon, resident of Maryland, green card resident, married to US Citizen hospitalized at University of Nebraska having gotten infected in Sierra Leone. He is critically ill and may not survive. He entered Nebraska Hospital with Creatinine of 16, pH of 7.1 and K+ of 2.0. NIH is thus up next for a patient. Nov. 17, 2014 - dies at Nebraska Medical Center. Nov. 19, 2014 - Today I testified before a Congressional Hearing of the House Committee on Commerce and Energy, Health Subcommittee chaired by Congressman Pitts from Pennsylvania with Dr. Burgess of Texas as the vice chair, and Mr. Henry Waxman of California as the ranking member. It was a lively hearing that went very well but with some interesting sharp interchanges between me and Dr. Cassidy from Louisiana. He is a physician who tried to show off about his medical knowledge in the hearing; however, during the exchange it became clear that he really did not know what he was talking about. In addition, Congressman Tim Murphy somewhat attacked me saying that I have been condescending to people who question the issue of conmtrolled trials with placebo limb, transmission, patient isolation and quarantine. I did not have the opportunity to refute him; however, after he had left when Mr. Burgess who took over the chair of the committee when Mr. Pitts left gave us the opportunity of a summary statement, I question Mr. Murphy's characterization of me as being condescending and clearly stated that our most important goal with interventions is to first do no harm and then hopefully benefit people and although many individuals feel that this is insensitive,