Anti-Ebola: Why Ebola drug can’t be brought to Africa – Obama

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ON Thursday, the federal government of Nigeria was awaiting reply from the US government over Anti-ebola experiment drug but United States President Barack Obama has said it is too early to
send experimental drugs for the treatment of Ebola to West Africa,
which has been hardest hit by the deadly outbreak.

Obama on Wednesday said affected countries should instead
focus on building a “strong public infrastructure,” adding: “I think
we have to let the science guide us. And I don’t think all the
information is in on whether this drug is helpful.”

The decision to use an experimental drug to treat two Americans
infected with Ebola, while nearly 1,000 Africans have already died
from the deadly epidemic, has sparked controversy.

Asked if, should the drug prove to be effective, he would support
fast-tracking its approval in the United States, Obama replied: “I
think it’s premature for me to say that because I don’t have
enough information. I don’t have enough data right now to offer an
opinion on that.”

Obama emphasized that Ebola, a hemorrhagic virus that kills
more than half of those infected, “is not an airborne disease.
“This is one that can be controlled and contained very effectively if
we use the right protocols.”
But he said: “the countries affected are the first to admit that
what’s happened here is the public health systems have been
overwhelmed. They weren’t able to identify and then isolate cases
quickly enough.”

“As a consequence, it spread more rapidly than has been typical
with the periodic Ebola outbreaks that occurred previously,” he
added.
He said the United States is working with European partners and
the World Health Organisation to provide resources to help contain
the epidemic.

“We’re focusing on the public health approach right now, because
we know how to do that, but I will continue to seek information
about what we’re learning with respect to these drugs, going
forward.”

A total of 932 people have died since March in Sierra Leone,
Guinea, Liberia and Nigeria, with 1,711 confirmed cases since the
beginning of the year.

Ebola is spread through direct contact with the bodily fluids of an
infected person.
Symptoms include fever, muscle aches, red eyes, diarrhea,
vomiting and bleeding.

The first European infected by a strain of Ebola, Spanish priest
Miguel Pajares, was stable in a Madrid hospital on Thursday after
being airlifted from Liberia, health authorities said.

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Pajares, 75, was working for a non-governmental organisation in
Liberia and was repatriated along with his co-worker Juliana Bohi,
a nun, who has tested negative for the disease.

Liberia has declared a state of emergency over the crisis.
“The patients have arrived well, though a little disoriented. They
are both now in quarantine,” Madrid health official Javier
Rodriguez told a news conference.

The medical plane flown out to Liberia to bring Pajares and Bohi
back to Spain touched ground at a military base in Madrid at 0600
GMT before the two were escorted by police motorbikes and cars
to the Carlos III hospital.
The hospital has cleared the entire sixth floor to treat the two
patients, the health union said.

Highly contagious, Ebola, which has no known cure, kills more
than half of the people who contract it. Victims suffer from fever,
vomiting, diarrhoea and internal and external bleeding.
Another report yesterday said the earliest the world can expect a
vaccine to curb spreading of Ebola in West Africa is about a year
away. And, even if the vaccine passes the initial phase of testing
in the U.S., it is unclear how effective it will be overseas.

“A U.S. trial will not necessarily predict what will happen in
Africa,” says Hildegund Ertl, the director of the Wistar Institute
Vaccine Center. For reasons not entirely understood, Africans have
different antibodies in their systems than Americans. Because
antibodies influence how the body receives a vaccine, a treatment
showing promise in a U.S. trial could still fail to thwart the
outbreak in Africa, which has killed almost 900 people to date.

There are currently “three or four different vaccine candidates, all
still in preclinical trials,” says Anthony Fauci, the director of the
National Institute of Allergy and Infectious Disease (NIAID). The
earliest one slated for clinical trials is yet unnamed, but testing is
expected to begin in September, pending approval from the Food
and Drug Administration (FDA).
That top candidate functions as follows: The vaccine is itself a
virus engineered to lack the gene necessary for replication—so
there is no risk the pathogen will spread throughout the body. It is
equipped with two Ebola genes that, once the vaccine enters the
body’s cells, will cause the body’s immune system to produce
antibodies. Ideally, these antibodies will protect the body in the
event of future exposure to Ebola.

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“That’s been done in animal models,” says Fauci, referring to
unpublished test of the vaccine candidate in non-human primates.
The results of the animal test are still being reviewed but, he says,
“the ones who were vaccinated were all protected.”

September’s clinical trials will be what is known as phase 1
testing. At this stage, the primary purpose is safety, says Ertl. If it
is established that the vaccine candidate is safe for humans, it will
then move on to phase 2, where, Ertl says, “you focus more on the
immune response.”

The candidate for September’s trial is a modified version of a
vaccine that entered phase 1 testing in 2010 but was ultimately
abandoned.

According to Fauci, if all goes well, scientists should know if
phase 1 testing is successful in January. But, as Ertl points out, to
be effective, the vaccine must be able to enter the patients’ cells.
“That’s what antibodies prevent,” she cautions. Due to the
different antibody levels in Americans and Africans, the vaccine
will need to be tested on Africans before scientists can get a sense
of how effective it will be.

Once phase 1 testing is completed in January, Fauci expects
phase 2 will be conducted on both American and African
populations. “If it proves to be safe, you expand the trial,” he
says. “All of that, the second phase, takes several months. You
need to scale up production of the virus.” From there, if the
vaccine is successful in both U.S. and African populations, it may
skip the third phase of trials and go directly to Africa. According to
Fauci, the earliest this might happen is “sometime before the end
of 2015”—a timetable he describes as “lightning speed.”

Should the candidate either fail phase 1 or prove ultimately
ineffective against antibodies in the systems of Africans, there
may be other options. According to Cmdr. Amy Derrick-Frost, a
spokesperson for the Department of Defense, “several vaccines
and therapeutics in various stages of development.” For example,
she cited the Defense Threat Reduction Agency’s three year, $10
million commitment to the development of a drug treatment for
Ebola known as ZMapp. The drug, which was designed by San
Diego-based Mapp Biopharmaceutical, has yet to enter phase 1
testing, but showed early some early success treating two
Americans, Dr. Kent Brantley and Nancy Writebol, who contracted
the virus while working in West Africa. Though neither is
considered cured, their conditions have improved since taking
ZMapp.

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According to Jennifer Routh, the scientific communications editor
at NIAID, her agency is also supporting efforts of the
biopharmaceutical company Crucell to develop another Ebola
vaccine. That candidate is scheduled for phase 1 clinical trials at
the end of 2015 or the beginning of 2016.

The FDA could not, by law, comment on specific treatments in
development, but Stephanie Yao, an agency spokesperson, tells
Newsweek that all were only in the “earliest stages of
development.”

It remains unclear why, of all the treatments in development,
ZMapp was the one chosen to be administered to Brantley and
Writebol. An NIAID official told Newsweek in an email that an NIH
scientist on the ground in West Africa assisting with the outbreak
response efforts was contacted for consultation and the scientist
was “able to informally answer some questions and referred them
to appropriate company contacts to pursue their interest in
obtaining experimental product. She was not officially
representing NIH and NIH did not have an official role in procuring,
transporting, approving, or administering the experimental
products administered to the two U.S. patients.”

Meanwhile, it remains unlikely that ZMapp will be given to any
African patients. For that drug to be used on patients in Liberia, it
would need to first be approved be the country’s Ministry of Health
Ethical Committee, Liberia’s chief medical officer Bernice Dahn
recently told the Wall Street Journal. Liberian officials are
expected to meet today with the World Health Organisation to see
if ZMapp, or one of the other experimental drugs, could be given
an emergency fast-track approval for use in their country.

The country’s assistant health minister, Tolbert Nyenswah said
the locals have begun asking for the treatment for their dying
relatives. “The population here is asking: ‘You said there was no
cure for Ebola, but the Americans are curing it?’”