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WMD Treatment Development Poses Significant Challenges, GAO Says

There are numerous obstacles to development of medical countermeasures that can be used to treat victims of a WMD attack, including the high rate of failure in efforts to put treatments on the market, the U.S. Government Accountability Office stated last week (see GSN, Jan. 24).

There are "few" accessible vaccines and other drugs that could be used to aid people exposed to chemical, biological, radiological or nuclear agent, according to a GAO report.

"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," the office said. "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.

"Smaller biotechnology companies are more likely to be developing medical countermeasures, but [the Health and Human Services Department] must provide more guidance to these less experienced small companies than might be typical with larger companies," congressional auditors added.

The GAO report also noted the need to ensure the effectiveness of treatments without actually exposing humans to WMD agents in testing; difficulties in establishing the correct dosage for children; and assessing the "safety and effectiveness" of unlicensed drugs that might be authorized for use during a health crisis.

"Finally, HHS faces the logistical challenge of ongoing replenishment of expiring medical countermeasures in the U.S. Strategic National Stockpile, the national repository of medications, medical supplies, and equipment for public health emergencies," according to GAO findings.

Health and Human Services is the lead department for identifying needed WMD countermeasures and for overseeing subsequent preparation and procurement activities. An interdepartmental entity that also includes the Homeland Security and Defense departments has been established to promote collaboration.

The health department has a four-part system for procuring medical countermeasures for WMD agents, the report says: determine and estimate the dangers posed by the materials; determine the "medical and public health consequences" of an incident involving a WMD agent; "establish medical countermeasure requirements"; and "identify and prioritize near-, mid- and long-term development and acquisition."

"Because most CBRN research does not result in viable countermeasures, HHS officials told us that they try to fund a larger set of candidates in the earlier stages of research in order to increase the likelihood that at least one candidate countermeasure may be successful," Cynthia Bascetta, GAO health care managing director, told a House Homeland Security subcommittee last week.

The Health and Human Services Department has set the goal of having available for an individual CBRN threat at least two viable medical treatments from different producers. That would address possible complications such as resistance to one drug among some patients or production troubles at one of the manufacturers (U.S. Government Accountability Office report, April 13).

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GSN ceased publication on July 31, 2014. Its articles and daily issues will remain archived and available on NTI’s website.