west africa patients not to benefit from the experimental drugs used by US in treatin Ebola

West African patients infected with the
Ebola virus will not have access to
experimental drugs being used to treat
American cases of the disease for
several months, if at all, Nigerian health
authorities said on Thursday.
Health minister Onyebuchi Chukwu told
a press conference he had asked the US
health authorities about the unproven
medicines used on two American
doctors, but was told such small
quantities existed that west Africa
would have to wait for months for
supplies, even if they were proved safe
and effective.
Dr Kent Brantly and Dr Nancy Writebol
of the evangelical Christian organisation
Samantha's Purse contracted the virus
while helping to treat victims in
Liberia. They were given the drug
ZMapp after being evacuated to the US,
and appear to be recovering.
A spokesman for the US Centres for
Disease Control said "there are virtually
no doses available" and they would take
several months to manufacture.
Even if supplies do become available,
medical ethicists are divided over
whether they should be used in the
current Ebola outbreak in west Africa .
The World Health Organisation (WHO)
has called a meeting of experts next
week to help it guide doctors and drug
companies who may consider shipping
experimental drugs to the four
countries hit by the disease.
"We are in an unusual situation in this
outbreak. We have a disease with a high
fatality rate, without any proven
treatment or vaccine," said Dr Marie-
Paule Kieny, assistant director general
at the WHO. "We need to ask the
medical ethicists to give us guidance on
what the responsible thing to do is."
Prof Jeremy Farrar, director of the
Wellcome Trust, welcomed the meeting,
saying there were critical ethical
questions to consider.
He called for the rapid establishment of
"rigorous protocols for the study of
experimental interventions", so that
African countries could have the same
opportunities to consider them as
western ones and to ensure there would
be equitable access to any treatment
that worked.
Jonathan Ball, professor of molecular
virology at Nottingham University, said
there were many questions.
"Giving unlicensed and untested (at
least in humans) treatments and
vaccines is a very thorny ethical issue,"
he said. "The infected US healthcare
workers are receiving a type of
treatment (antibodies that specifically
target the virus) that has a reasonably
long safety track record, so it isn't
surprising – given the high fatality rate
in the current outbreak – that they are
happy to receive the therapy.
"But not all drugs are safe – that's why
we have very stringent clinical trials.
One could argue that the current
outbreak provides a perfect arena in
which to test new drugs, but that isn't
without risk. We don't know their
safety, we don't know if they are likely
to work – sure, they have been tested in
animals, but these studies don't always
tell us what will happen in humans."
Some of the new treatments have not
been tried with human at all, said Prof
Tom Solomon, director of the NIHR
health protection research unit in
emerging and zoonotic infections. It is
usual for drugs to be tried in healthy
volunteers first, in case of side-effects.
"The difference here is the desire for
this 'first in man' experiment to be for a
patient with the disease," he said.
"What is key is that if these new
experimental drugs are going to be
used, then this should only be done in
the context of a clinical trial. Otherwise
the worry is that we will have tried
these drugs, including putting people
through the potential risk of
experimental treatments, and still be
none the wiser about which are
effective."
Paul Hunter, professor of health
protection at the University of East
Anglia, said most doctors in a situation
like that of west Africa would want to
try a drug that might work.
"In my view, the ethical case is
unequivocal. If a patient is likely to die
and an experimental therapy has a
reasonable chance to prevent death,
then it should be given. However, this
does not mean that any old drug could
be given. For an experimental
compound to be given, there should be
good prior evidence that the therapy
will work, the patient or his relatives
should give informed consent wherever
possible and whenever the therapy is
given proper records must be kept and
the outcome reported to WHO," he said.
Unicef, meanwhile, warned that
children who had been orphaned by
Ebola were finding themselves shunned
by their communities. "Children who
are orphaned by the disease are finding
it hard to be accepted in their
communities and this has had huge
psychological impacts on their lives,"
said the Unicef representative in Sierra
Leone, Roeland Monasch.
"The Ebola outbreak has led to
widespread misconceptions and myths
and these are posing serious challenges
in the fight to eradicate it."