Critics Claim Plant Duplicates HHS Efforts
By Sandra Basu
WASHINGTON — For the first time, DoD is partnering with an outside company to build a facility to manufacture countermeasures to fight bioterrorism and other medical threats.
Critics are calling the project costly and duplicative, however, noting that the U.S. Department of Health and Human Services (HHS) has funded three centers doing similar work. A DoD spokesperson responded that the military’s plant has a different mission than the HHS centers.
“The DoD plans to use the facility to manufacture medical countermeasures for development through FDA licensure or expand manufacturing of existing FDA-approved products. Examples may include vaccines against alpha viruses, hemorrhagic fever viruses, intracellular parasites, select biotoxins, emerging disease agents and genetically engineered biological agents,” Cicely Levingston, a spokesperson for the Joint Program Executive Office for Chemical and Biological Defense, told U.S. Medicine in a statement.
Groundbreaking for the facility in Alachua, FL, was in October, with commissioning of the facility planned for March 2015. Construction of the plant, which will be a contractor owned and operated facility, is being funded by Nanotherapeutics Inc. DoD is paying for the procurement and installation of the specialized pharmaceutical, single-use, modular manufacturing equipment.
“This is the first time the DoD has entered into such an agreement for the development of single use, modular manufacturing capabilities in the area of Chemical, Biological, Radiological and Nuclear defense,” Levingston pointed out.
Concerns About Bioterrorism
The military has become increasingly concerned about combating bioterrorism. At a hearing held by the House Armed Services Committee on bioterrorism this past fall, experts warned that preparation to combat biological weapons must be taken seriously.
“Over the last two decades, terrorists have wreaked havoc with bombs and bullets far more frequently than with disease, but no one should be complacent about the biological weapons threat,” said Amy Smithson, PhD, Monterey Institute of International Studies Senior Fellow.
Developing biological weapons has become easier for enemies who seek to do so, the experts said. Texas A&M Health Science Center Interim Executive Vice President and CEO Brett Giroir, MD, told lawmakers that what took him weeks during medical school to produce in a multimillion-dollar laboratory can be done in an afternoon on a benchtop by someone with much less training.
“The barriers to entry have decreased,” Giroir warned.
Maj. Gen. Phillip Russell (ret.), MD, a former commander of the U.S. Army Medical Research and Development Command, said that information on biological manufacturing such as aerosol powders is “widely available on the Internet.”
“I think we have seen a tremendous shift in advantage to our adversaries in this regard because of the ability of a very small group of people with the expertise to manufacture these weapons,” he said.
Biochemical weapons aren’t the only threat, according to Levingston, who pointed out that “any infectious disease, whether due to an act of bioterrorism, an emerging disease agent or genetically engineered biological agent poses a serious threat to U.S. military forces by reducing the combat effectiveness of military units.”
She explained that the new facility will enable DoD to “rapidly produce medical countermeasures at a scale suitable to the warfighters’ needs.”
“The facility’s production capability can surge, if required, to meet higher demand. In the current fiscal environment, the facility’s capabilities will create efficiencies of cost and time for product development and manufacturing of medical countermeasures,” she said.
Controversy Over Costs
The need for the new plant has not been without controversy, however. A Los Angeles Times article in November suggested that the plant is duplicative of efforts underway by Health and Human Services to produce medical countermeasures. HHS has awarded funding to three national centers for Advanced Development and Manufacturing (ADM) to develop and manufacture medical countermeasures, such as vaccines and medicines that will be used to protect the public in emergencies.
The Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM) is one of these three national centers. Giroir told lawmakers at the hearing that the HHS capacity could accommodate the needs of DoD personnel.
“Programs such as our HHS center [are] fully capable of performing the advanced development and manufacturing on both military or civilian measures. The technologies are all the same, the platforms are all very similar,” he said.
He further explained in written testimony that preliminary estimates suggest that by utilizing the pre-existing and already funded capacity provided by HHS, “the DoD can guarantee all the availability required, with substantially less risk, for 10 years, at approximately half of the initial facility costs budgeted for a dedicated DoD facility.”
Levingston countered, however, telling U.S. Medicine that the DoD ADM is designed to produce medical countermeasures that address a broad array of threats that troops may encounter globally on a small scale, while the HHS’ three centers will focus on producing doses on a much larger scale for a smaller set of threats to the U.S.
“The DoD has and will continue to collaborate with HHS on any work or products that might be considered in any of the three HHS ADM facilities for the manufacture of medical countermeasures on a case-by-case basis. The DoD ADM will be a shared capability, available for use by DoD’s partnering organizations, industry members and academia as part of a national system that includes the HHS ADMs,” she explained.
The process for tracking the DoD’s most serious adverse medical events is “fragmented, impeding the Defense Health Agency’s (DHA) ability to ensure that it has received complete information,” according to a new review.
With a long history of point of care testing at both of its predecessor organizations, the Walter Reed National Military Medical Center (WRNMMC) laboratory services staff were keenly aware of the advantages of using portable testing devices to obtain rapid patient assessments.