Two American missionary workers
infected with the deadly Ebola virus
were given an experimental drug
that seems to have saved their lives.
Dr. Kent Brantly was given the
medication, ZMapp, shortly after
telling his doctors he thought he
would die, according to a source
familiar with his case. Within an
hour, doctors say his symptoms —
labored breathing and a widespread
rash — dramatically improved. Nancy
Writebol, another missionary working
with Samaritan’s Purse, received two
doses of the medication and has also
shown significant improvement,
sources say.
As there is no proven treatment and
no vaccine for Ebola, this
experimental drug is raising lots of
questions.
Health workers evacuating the
remains of an Ebola Virus Disease
victim.
Health workers evacuating the
remains of an Ebola Virus Disease
victim.
1. Who makes the drug?
The drug was developed by the
biotech firm Mapp Biopharmaceutical
Inc., which is based in San Diego.
The company was founded in 2003
“to develop novel pharmaceuticals
for the prevention and treatment of
infectious diseases, focusing on
unmet needs in global health and
biodefense,” according to its website.
Mapp Biopharmaceutical has been
working with the National Institutes
of Health and the Defense Threat
Reduction Agency, an arm of the
military responsible for countering
weapons of mass destruction, to
develop an Ebola treatment for
several years.
2. Are there other experimental
Ebola drugs out there?
Yes. In March, the NIH awarded a
five-year, $28 million grant to
establish a collaboration between
researchers from 15 institutions who
were working to fight Ebola.
“A whole menu of antibodies have
been identified as potentially
therapeutic, and researchers are
eager to figure out which
combinations are most effective and
why,” a news release about the
grant said.
Tekmira, a Vancouver-based company
that has a $140 million contract
with the U.S. Department of Defense
to develop an Ebola drug, began
Phase 1 trials with its drug in
January. But the FDA recently halted
the trial, asking for more
information.
At least one potential Ebola vaccine
has been tested in healthy human
volunteers, according to Thomas
Geisbert, a leading researcher at the
University of Texas Medical Branch.
And last week, the NIH announced a
safety trial of another Ebola vaccine
will start as early as September.
3. How does ZMapp work?
Antibodies are proteins used by the
immune system to mark and destroy
foreign, or harmful, cells. A
monoclonal antibody is similar,
except it’s engineered in a lab so it
will attach to specific parts of a
dangerous cell, according to the
Mayo Clinic, mimicking your immune
system’s natural response.
Monoclonal antibodies are used to
treat many different types of
conditions.
The medicine given to Brantly and
Writebol abroad was a three-mouse
monoclonal antibody, meaning that
mice were exposed to fragments of
the Ebola virus and then the
antibodies generated within the
mice’s blood were harvested to
create the medicine.
However, the drug can also be
produced with proteins made from
tobacco plants. ZMapp manufacturer
Kentucky BioProcessing in Owensboro
has been working with Samaritan’s
Purse and Emory University Hospital
to provide limited quantities of the
drug to Emory, according to company
spokesman David Howard.
4. Why did American missionary
workers get the drug?
Many have asked why these two
workers received the experimental
drug when so many — around 1,600
— others in West Africa also have
the virus.
The World Health Organization says
it was not involved in the decision
to treat Brantly and Writebol. Both
patients had to give consent to
receive the drug, knowing it had
never been tested in humans before.
The process by which the medication
was made available to the American
patients may have fallen under the
U.S. Food and Drug Administration’s
“compassionate use” regulation,
which allows access to
investigational drugs outside clinical
trials.
5. Did doctors know it would work?
No. The drug had shown promise in
primates, but even in those
experiments, just eight monkeys
received the treatment. In any case,
the human immune system can
react differently than primates’,
which is why drugs are required to
undergo human clinical trials before
being approved by government
agencies for widespread use.
The two Americans’ cases will be
studied further to determine how
the drug worked with their immune
systems.
6. Will the drug be made available
to other Ebola patients?
It’s unclear. Rolling out an untested
drug during a massive outbreak
would be very difficult, Doctors
Without Borders said in a statement.
Experimental drugs typically not
mass-produced, and tracking the
success of such a drug if used would
require extra medical staff where
resources are already scarce.
Dr. Anthony Fauci, director of the
National Institute of Allergy and
Infectious Diseases, says scientists
have to be careful about assuming
this drug will work in other patients
as it appears to have worked in
Brantly.
“Having worked with administering
antibodies for people for a really
long time, that would be distinctly
unusual,” he told CNN. “As we all
know in medicine … you have to
withhold judgment.”
7. Does the company have more
vials of the drug?
The company has very few doses
ready for patient use, Fauci told
CNN.
“(Kentucky BioProcessing) is working
closely with Mapp, various
government agencies, and other
parties to increase production of
ZMapp, but this process will take
several months,” Howard said.
8. Who paid for the drug and how
much did it cost?
We don’t know. Samaritan’s Purse
covered the cost of Brantly and
Writebol’s evacuations but did not
pay for the drug, according to a
spokesman.
When a patient gets an experimental
drug, the drug company can donate
the product under compassionate
use. Mapp Biopharmaceutical Inc.
might have done that in this case.
Health insurance companies typically
do not pick up the tab for
treatments that have not been
approved by the FDA. But they
usually would cover the cost of any
doctor fees associated with giving
the drug and any costs associated
with monitoring how the drug is
working.
9. Would this drug stop the Ebola
epidemic?
If it were widely available, it
certainly couldn’t hurt. An effective
Ebola drug could help doctors treat
the deadly virus, which is killing
about 60% of the people infected in
West Africa. But a vaccine would be
a much more effective tool in
stopping this, and future, epidemics.
Vaccines are given to healthy people
to prevent them from ever becoming
infected. One challenge with Ebola,
experts say, is that companies don’t
believe they could make much
money from developing a vaccine, so
few companies show interest.
http://www.vanguardngr.com/2014/08/nine-questions-new-ebola-drug/

What is Africa doing about this epidemic?
Does it mean Africa lacks scientific/research initiatative to taclkle this problem?
Waiting for positive reaponse........