|
 The group is being formed under Dr. Nicole Lurie, Assistant
Secretary for Preparedness and Response at the Department of Health
and Human Services, an administration official said.
The action follows mounting international pressure as the death toll
mounts to consider using untested treatments. The World Health
Organization (WHO) is due to consider next week the ethics of
administering such drugs.
Ebola has claimed at least 932 lives, according to the WHO.
The U.S. group will include scientists and officials from such
agencies as the National Institutes of Health (NIH) and the Centers
for Disease Control and Prevention (CDC), according to Dr. Anthony
Fauci, director of NIH's National Institute of Allergy and
Infectious Diseases (NIAID).
Calls to consider making unapproved drugs available to Ebola
patients have grown since two U.S. aid workers infected with the
deadly virus received an experimental treatment that may have helped
them.
The drug, from California-based Mapp Biopharmaceutical Inc, had only
been tested on monkeys. It is one of several being considered for
use by people infected with Ebola.
Early human clinical trials for a drug from Canada's Tekmira
Pharmaceutical Corp had been put on hold by U.S. regulators. On
Thursday, the company said the hold had been partially lifted to
enable its potential use by infected patients.
Fauci said in an interview that he was not certain when the group
would have its first meeting or who would be there, but he said,
"I'm sure they'll tap people from NIAID with competence in clinical
trials."
Expertise in clinical trials, in which patients receive an
experimental drug under scientifically rigorous conditions, is
crucial, Fauci said.
"You need to balance compassion with the need to figure out if
something actually works," he said.
Countless experimental drugs have cured lab animals but failed to
work in people or even caused harm. For that reason, Fauci said,
"You can't just willy-nilly give out a drug. You have a
responsibility to at least rule out that it is harming people and to
make some effort to find out if it works."
[to top of second column] |
If compassion dictates providing experimental compounds to Ebola
patients in West Africa, he said, then the way to meet the ethical
obligation to determine safety and efficacy is through a clinical
trial, such as by giving a drug to 50 Ebola patients in a hospital
in Liberia and comparing them to 50 patients who do not get it.
That requires adequate supplies of a drug. "There is an extremely
limited supply and in some cases no supply of these drugs that
people are reading about," Fauci said, referring to media reports
about the experimental drugs.
Policymakers need to determine whether there is a way to identify
the experimental compounds most likely to help, presumably via lab
animal studies, and which could undergo "accelerated production to
introduce in controlled sites and at least begin doing something,"
said J. Stephen Morrison, a global health expert who worked for the
U.S. State Department during the Clinton administration.
Separate from the Ebola working group, the administration official
said the CDC was pursuing a short-term strategy to control the
spread of the outbreak by establishing and supporting medical
infrastructure in affected countries.
The CDC's long-term strategy is aimed at preventing future
outbreaks.
(Reporting by David Morgan and Sharon Begley; Editing by Michele
Gershberg, G Crosse, Toni Reinhold)
[© 2014 Thomson Reuters. All rights
reserved.] Copyright 2014 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
