U.S. News
Patients Got Unapproved Ebola Drug
Two Americans Were Given Medicine in Liberia; Another Man Tested in New York
Updated Aug. 4, 2014 8:27 p.m. ET
ATLANTA—Two Americans infected with Ebola in
Liberia—one in a hospital here and another set to arrive Tuesday—were
treated in that West African country with an experimental drug not yet
evaluated for safety in humans.
It is
too early to know if the drug, developed by a U.S. company, has been
successful, said Anthony Fauci, director of the National Institute for
Allergy and Infectious Diseases.
Dr.
Fauci added Monday that a clinical trial that includes more patients
would be needed to demonstrate the drug's efficacy and safety.
There is no approved vaccine or
treatment for Ebola, a deadly disease that has been spreading through
the West African nations of Liberia, Guinea and Sierra Leone. It is the
largest outbreak of the disease in history.
In
New York City on Monday, Mount Sinai Hospital officials said they were
testing a man for Ebola who recently returned from West Africa with a
high fever and gastrointestinal distress. Authorities, who say the man
is in isolation, wouldn't identify him or the country he had visited.
"This is no more than a low to a moderate risk" the man has Ebola, said Mount Sinai President David Reich.
Meanwhile,
Nigerian health authorities said they had confirmed a second case of
Ebola in that country. There have been more than 1,600 cases of Ebola
since the disease emerged in West Africa this year, according to the
World Health Organization.
The
experimental drug administered to the two Americans is called ZMapp, and
is being developed by San Diego Mapp Biopharmaceutical Inc., according
to NIAID, Dr. Fauci's institute.
Mapp
and an affiliated company, LeafBio, are collaborating with a Canadian
company, Defyrus Inc., to develop the treatment, which is composed of
three monoclonal antibodies, according to a statement from Mapp and
LeafBio.
ZMapp hasn't been evaluated for
its safety in humans, according to the companies. Mapp and its partners
are cooperating with government agencies to increase production as
quickly as possible, according to the statement. Mapp officials couldn't
immediately be reached. An executive with Defyrus referred questions to
the company's chief executive, who couldn't be reached.
Mapp
said in its statement: "Any decision to use an experimental drug in a
patient would be a decision made by the treating physician under the
regulatory guidelines of the FDA."
Dr.
Fauci said NIAID wasn't directly involved in getting the experimental
drug to the two Americans, but it did fund some early research behind
the treatment.
Asked about U.S. media
reports that the drug was effective in the two American patients, Dr.
Fauci said "you can't prove it" until the treatment is tested in "a
clinical trial with a whole bunch of people."
NIAID,
meantime, is developing an Ebola vaccine candidate, which was effective
in protecting monkeys against Ebola in tests, Dr. Fauci said. NIAID
plans to start a trial in healthy human volunteers in September to test
the serum's safety and to see whether it induces an immune response
likely to be protective against Ebola. Results could be ready in January
2015.
"I think we're going to get a
vaccine and, I think, good drugs," Dr. Fauci said, but they are unlikely
to be ready for widespread use in the current outbreak.
Word
of the experimental drug came as the second American infected with
Ebola in Liberia is expected to arrive in Atlanta for treatment Tuesday,
according to SIM USA, the Christian charity for which the woman
volunteered.
Nancy Writebol,
59 years old, who had been helping decontaminate workers at an
Ebola center, is in serious condition, said the Charlotte, N.C., group.
She will be flown in an ambulance jet from Liberia to Dobbins Air
Reserve Base outside of Atlanta and then driven in a specially equipped
ambulance with a law-enforcement escort to Emory University Hospital.
At
Emory, she will be placed in an isolation unit near Kent Brantly, a
33-year-old doctor from Texas who was infected at the Liberian clinic
where both worked. Dr. Brantly was brought to Emory on Saturday.
Samaritan's
Purse, one of the charities operating the center and the group that
brought Dr. Brantly to Liberia, had no updates on his condition Monday.
On Sunday, it released a statement saying the doctor's condition was
improving. Emory declined to comment. The charities said the two
Americans were given the experimental drug in Liberia.
The
viral hemorrhagic fever, spread through contact with bodily fluids,
causes symptoms such as fever, headaches, vomiting and diarrhea, and can
cause internal bleeding.
Supportive
care, such as fluids to replace those lost in vomiting and diarrhea,
drugs to bring down fevers and antibiotics for complications, can
improve a patient's chances of survival by keeping the immune system as
strong as possible to fight off the virus.
—Will Huntsberry contributed to this article.
Write to Peter Loftus at peter.loftus@wsj.com and Cameron McWhirter at cameron.mcwhirter@wsj.com
Ristori
G, Romano S, Cannoni S, Visconti A, Tinelli E, Mendozzi L, Cecconi P,
Lanzillo R, Quarantelli M, Buttinelli C, Gasperini C, Frontoni M,
Coarelli G, Caputo D, Bresciamorra V, Vanacore N, Pozzilli C, Salvetti
M.
Neurology. 2014 Jan 7;82(1):41-8. doi: 10.1212/01.wnl.0000438216.93319.ab. Epub 2013 Dec 4.
- PMID:
- 24306002
- [PubMed - indexed for MEDLINE]
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