Ebola: Untested Ebola drugs ethical – WHO

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THE two Americans, Dr. Kent Brantly and Nancy Writebol, appear
to be recovering after the first two doses of an experimental serum created to treat Ebola were administered to them. The drug was also sent to treat a Spanish priest. But pitifully, The priest, Miguel Pajares, died Tuesday morning.

That’s the problem with experimental drugs that have never been
clinically tested in humans: No one knows whether they’ll work —
and if they do, in whom.

This week, the World Health Organization gathered a group of
ethicists to decide whether proven medications and vaccines
should be used in the current Ebola outbreak. As the death toll
from the epidemic soared over 1,000, the WHO panel unanimously
concluded that it is ethical to offer medications to fight the Ebola
virus, even if their effectiveness or adverse effects are unknown.

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“The large number of people affected by the 2014 west Africa
outbreak, and the high case-fatality rate, have prompted calls to
use investigational medical interventions to try to save the lives of
patients and to curb the epidemic,” the World Health
Organization said Tuesday.

WHO says it believes the virus has infected 1,848 people and
killed 1,013, making this the deadliest Ebola outbreak in history.
The difference between this outbreak and other Ebola outbreaks is
that traditional methods of stopping the virus from spreading —
protective gear, contact tracing, etc. — don’t seem to be working
fast enough, said Dr. Marie-Paule Kieny, WHO’s assistant
director-general. The health care systems in the affected countries
are also weak, so resources are scarce.

“If these treatments can save lives, should we not use them to
save lives?” Kieny said the panel asked.

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Desperation has pushed Liberia’s government to ask for the
experimental serum used to treat the Americans and Spanish
priest, in order to treat two local doctors.

The U.S. Food and Drug Administration approved Liberia’s request
for access to ZMapp, which was created by the San Diego-based
biotech firm Mapp Biopharmaceutical Inc. Sample doses of the
medicine will be sent to Liberia this week to treat doctors who
have contracted the virus, the Liberian government said.

Mapp Biopharmaceutical said Monday that its supply has been
exhausted after fulfilling the request of a West African country. (It
did not name the country.) Kentucky BioProcessing, which
manufactures a version of the drug, is working to increase
production of ZMapp, but the process will take several months,
company spokesman David Howard said last week.

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“There are not adequate supplies of any of the investigational
agents anywhere near ready for human use,” said Dr. Jesse
Goodman, director of the Center on Medical Product Access, Safety
and Stewardship at Georgetown University Medical Center,
referring to all drugs being developed to treat Ebola.
“Not (adequate) to treat all the patients in this outbreak, even if we
knew they worked.”