Ebola virus strand |
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.
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.
Sources told CNN
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.
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.
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