Tuesday, February 3, 2015

Testified today at Congressional Hearing of Commerce and Energy oversight Committee (Tim Murphy (R-PA) Chair on Influenza and why the match of vaccine was wrong. Multiple things putting me at the forefront – measles, Ebola, bad flu season. Will do Rachel Maddow Show tonight. Measles is all over the news. Also, ISIS sent a video where they burned alive a captive Jordanian pilot. See e-mail below from Cliff. Serious problem with integrity of the Welcome trust people and Chimerix. The Welcome trust Oxford group were the ones that criticized us for wanting to do RCTs. We insisted that it was the safest and best way to determine efficacy or harm. They said we were unethical. They are unethical and we cannot say anything because of “confidentiality”. From: Lane, Cliff (NIH/NIAID) [E] Sent: Tuesday, February 03, 2015 5:08 PM To: Borio, Luciana (FDA/OC); Fauci, Anthony (NIH/NIAID) [E] Cc: Margaret Hamburg Subject: Re: Daily Mail: Low infection rate halts Ebola vaccine trials in Liberia Confidential - This is a complete distortion. The trial was stopped because patients died and the FDA sent a threatening letter to the company. Questions on this will undoubtedly come up as we launch the ZMapp trial. These same individuals accused us in print of being unethical for doing RCTs. Lu - I need to know what I (or Tony) can say publicly. For the first time in a 35 year career at the NIH I am taking my gloves off. Tony - I intend to severe any and all collaborations we have with the Wellcome Trust over what I consider to be completely unethical behavior and lack of integrity. Peggy - if I had not worked with you when you were a special assistant in Tony's off ice there is no chance I would see such a note to the FDA Commissioner. I apologize in advance. Somewhere in HHS we need to move from political correctness and deference to our colleagues in other agencies to doing the right thing and trying our best to identify effective countermeasures for Ebola virus disease. It is possible my judgement is being skewed by spending too much time in West Africa. In fact, however, it I think it has been honed. I think we need a blunt meeting with the Secretary and Leadership of FDA, CDC and NIH to put the cards on the table face up. Cliff On Feb 3, 2015, at 7:27 PM, Doepel, Laurie (NIH/NIAID) [E] <LDOEPEL@niaid.nih.gov> wrote: Low infection rate halts Ebola vaccine trials in Liberia By Afp Published: 14:17 EST, 3 February 2015 | Updated: 14:17 EST, 3 February 2015 Britain's Wellcome Trust said that clinical trials it was funding for a new Ebola vaccine in Liberia were halted on Tuesday due to a fall in new cases. "The current position is that there is no realistic prospect of the trial enrolling sufficient patients to be able to reach a conclusion about the efficacy of the drug," the Wellcome Trust, Britain's biggest scientific research charity, said in a statement. "Therefore the trial has been terminated," it added. The Wellcome Trust said the decision was taken on Tuesday after the pharmaceutical company Chimerix, which manufactures the brincidofovir vaccine, said it was withdrawing from the trial on Friday. The first large-scale trials of two other Ebola vaccines -- GlaxoSmithKline's Chad3-EBO-Z and rVSV-ZEBOV, manufactured by Merck and Newlink -- began in Liberia on Monday. Tuesday's decision was taken by the Trial Steering Committee, which includes scientists from Liberia, the University of Oxford and Medecins Sans Frontieres. "We're delighted that infections are falling, but fewer patients makes it more difficult to carry out the robust scientific studies needed," Peter Horby from the University of Oxford, who was leading the trial, said in a statement. Jeremy Farrar, director of the Wellcome Trust, which is funding a multimillion pound therapeutics platform for experimental Ebola treatments, said it was "disappointing" that the trial could not continue. "It is essential that other studies of potential treatments and vaccines continue and hopefully will still be able to deliver meaningful results for this and the inevitable future epidemics of Ebola," he said. Stephen Kennedy, a study investigator from the Pacific Institute for Research and Evaluation in Liberia added: "The scientific community will move on without any clear evidence regarding the role of brincidofovir in the management of Ebola." Weekly Ebola infections in west Africa have dropped to below 100 for the first time in more than six months, the WHO said last week, raising hopes the worst-ever outbreak of the virus is coming to an end. The World Health Organisation said it had now shifted its efforts in Guinea, Liberia and Sierra Leone -- the countries worst-hit by the epidemic -- from slowing the spread to stamping it out completely.