By: Anthony Kimery
There are a few chemical, biological,
radiological and nuclear (CBRN) countermeasures that can be immediately
acquired to help protect Americans from a CBRN terrorist attack, but
“most have not yet been developed,” Cynthia Bascetta, managing director
of health care issues at the Government Accountability Office (GAO), told a
congressional subcommittee last week during the first of a series
of hearings that examined the government’s progress in developing CBRN
countermeasures.
The hearing by
the House Committee on Homeland Security's subcommittee on emergency
preparedness, response and communications was the first of a series of
hearings that continued this week to review government and industry
efforts to protect the homeland through accelerated research,
development and acquisition of CBRN medical countermeasures.
Bascetta told the panel, “The federal government
faces a variety of challenges in developing and acquiring medical
countermeasures, such as the high failure rate in research and
development and difficulties meeting regulatory requirements.”
“For example,” Bascetta said, “the failure rate for
development and licensure of most drugs, vaccines and diagnostic devices
can be more than 80 percent, depending on the stage of scientific
research and development. Given this risk, as well as a lack of a
commercial market for most medical countermeasures, attracting large,
experienced pharmaceutical firms to research and develop them is
challenging.”
Bascetta said, "Smaller biotechnology companies are
more likely to be developing medical countermeasures, but [the
Department of Health and Human Services, HHS] must provide more guidance
to these less experienced small companies than might be typical with
larger companies.”
HHS coordinates and leads federal efforts to
determine CBRN medical countermeasure priorities and develop and acquire
CBRN medical countermeasures, primarily through an interagency body
that includes other federal agencies with related responsibilities,
including the Department of Homeland Security (DHS) and Department of
Defense.
“In addition,” Bascetta continued, “several
challenges exist related to regulatory processes for evaluating
promising medical countermeasures. These challenges include proving a
countermeasure’s effectiveness using animals as proxies for humans,
because humans cannot ethically be used in studies involving CBRN
agents; determining appropriate doses of countermeasures for children,
who may be more vulnerable to exposure to CBRN agents; and evaluating
the safety and effectiveness of medical countermeasures for use in a
public health emergency if they have not yet been approved or licensed.
Finally, HHS faces the logistical challenge of ongoing replenishment of
expiring medical countermeasures in the US Strategic National Stockpile,
the national repository of medications, medical supplies and equipment
for public health emergencies.”
HHS’s medical countermeasures acquisition strategy
is based on a four-step process: identify and assess the threat of CBRN
agents; assess medical and public health consequences of attacks with
these agents; establish medical countermeasure requirements; and
identify and prioritize near-, mid- and long-term development and
acquisition.
“Through these processes,” Bascetta explained, “HHS
determines which countermeasures to buy for specific CBRN agents,
including the desired characteristics of these countermeasures -- such
as how many doses a vaccine requires to confer immunity -- the needed
quantity of certain medical countermeasures and the acquisition
priorities.”
HHS and the interagency body support and oversee
several stages of research and development to try to obtain usable
countermeasures, including basic cellular and biological research to
understand the effects of these agents on humans. They also oversee
applied research to validate approaches, such as testing the
effectiveness of treatments in animals, early development to assess the
safety of potential countermeasures, and advanced development that
evaluates products more fully for safety and effectiveness, including
their formulation and manufacturing processes.
“Ensuring the availability of medical
countermeasures that will save lives during a public health crisis (such
as pandemic influenza) or weapons of mass destruction attack (such as
anthrax) is the responsibility of the US government. BIO and its members
were therefore encouraged [when the HHS secretary began] an intense
review of the Public Health and Emergency Preparedness Enterprise
(PHEMCE)," Phyllis Arthur, senior director for vaccines,
immunotherapeutics and diagnostics policy at the Biotechnology Industry
Organization (BIO), told the subcommittee.
“BIO,” Arthur told lawmakers, “actively engaged in
this process, participating in stakeholder meetings related to most
facets of the enterprise. Some of the recommendations from industry were
incorporated into the final review and still others can be included in
the upcoming reauthorization of the Pandemic and All-Hazards
Preparedness Act (PAHPA) or other biodefense-related vehicles moving
through Congress.”
Arthur said, “The lack of a viable commercial market
for most of these products necessitates the active engagement of the
government in the development of these essential products. Over the last
ten years, bipartisan congressional efforts have created and funded an
enterprise that has begun to show success. In the past two years,
several key countermeasures in the area of smallpox and anthrax have
been delivered to the Strategic National Stockpile. Furthermore several
key procurement contracts have been issued that will lead to the final
development of other countermeasures. Future plans and investments are
pivotal to continue that success and further strengthen and improve the
responsiveness of the United States.”
http://www.hstoday.us/home.html
