Re: Daily Mail: Low infection rate halts Ebola vaccine trials in Liberia
Diary Prequel Package, pp.423-426 · diary_prequel:email:00013
Page text: p.423, p.424, p.425, p.426 · original PDF
- Date
- 2015-02-03 17:08
- Type
- email · email
- sender
- H. Clifford Lane
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 I 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.
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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.