Medical Aspects of Chemical Warfare (2008) - The Black Vault

Medical Chemical Defense Acquisition Programsequipment decontamination, etc). The JPEO-CBD isresponsible for developing, acquiring, fielding, andsupporting chemical and biological defense equipmentand medical countermeasures that support the nationalmilitary strategy.The JPEO-CBD medical programs are managed by asubordinate organization, the chemical and biologicalmedical systems joint project management office, headquarteredat Frederick, Maryland. This office overseesthree joint product management components: the jointvaccine acquisition program, the newly establishedtransformational medical technologies initiative, andthe medical identification and treatment systems jointproduct management office (MITS JPMO). The jointvaccine acquisition program is responsible for developingand fielding vaccines and associated products toprotect military personnel against biological warfareagents. The transformational medical technologiesinitiative enables the DoD to protect service membersfrom novel (and potentially genetically engineered)biological threats through the rapid development ofeffective therapeutic medical countermeasures, minimizingrisks and saving lives. The advanced developmentof therapeutic and diagnostic products, whichincludes chemical defense programs, is managed bythe MITS JPMO. The mission of the MITS program is todevelop and acquire safe, effective, and FDA-approvedproducts for the prophylaxis, treatment, and diagnosisof CBRN warfare agent exposure. The MITS JPMO isalso responsible for the critical reagents program, therepository for reagents (probes and primers) and assaykits used in DoD biological detection/diagnostic systems.All MITS medical countermeasures undergoingadvanced development for use against CBRN agentsare fully integrated into the JPEO-CBD systems of approachto counter threat agents, thereby supporting anintegrated diagnostic, prophylactic, and therapeuticcapability. MITS medical countermeasures supplementand are compatible with all the equipment developedunder JPEO-CBD.MEDICAL CHEMICAL ACQUISITION PROCESSES and CONCERNSThe major ground rules for the defense acquisitionprocess are contained in the DoD 5000 seriesdocuments. 3,4 The federal acquisition regulations andsupplements also pertain to this process. 5Drugs must pass through several phases of clinicaltrials in order to obtain FDA approval (Figure 20-2).All human research trials conducted in support ofthe FDA approval process must follow strict FDAregulations and guidelines (“good clinical practices”).In Phase 1 clinical trials, a new drug is first tested ina small group of healthy volunteers (usually 20–80)to evaluate its safety, determine a safe dosage range,identify side effects, and determine how the drug isabsorbed, distributed in the body, metabolized, andexcreted. In Phase 2 clinical trials, the study drug isgiven to a larger group of people (usually around severalhundred subjects) to evaluate effectiveness and tofurther evaluate safety. In typical Phase 3 studies, thestudy drug is given to even larger groups of people,up to several thousand, to confirm its efficacy, monitorside effects, compare it to commonly used treatments,and collect drug safety data. However, Phase 3 studiesare not used for the approval of medical chemicalcountermeasures because it is unethical to test theeffectiveness of any drug against chemical warfareagents in people. To overcome this obstacle, the MITSJPMO plans to invoke the “animal rule” (sometimescalled “the animal efficacy rule”), which allows for thetesting and approval of products when human efficacyclinical trials are not feasible or are unethical, 6 as DoDaccepts this means to licensure. The Phase 2 clinicaltrials are used as expanded safety studies for medicalchemical countermeasure development and may bedivided into multiple arms or studies to address allthe regulatory concerns. Phase 4 (post-marketing)studies are conducted after a drug is already approvedand on the market. Concurrent with the approval, theFDA may require certain post-marketing studies todelineate and document additional information abouta drug’s risks, benefits, and optimal use, or it maycollect retrospective data on the safety and efficacyof the product if it is ever used. This is especially truefor drugs approved under the animal rule. All FDArequiredPhase 4 studies are the responsibility of thesponsor, whether that is the US Army Office of TheSurgeon General or a system integrator.Medical CBRN products are developed using a mixof in-house experts and commercial contractors. Withinthe acquisition process, drug development programsmust pass through a series of gates or milestones. Amilestone is a point in which a recommendation ismade and approval is sought regarding starting orcontinuing an acquisition program.Concept Development (Pre-Milestone A Activities)Drug development decisions must take place earlierin the acquisition process than the typical DoD weaponsystem development program, requiring earlier userinvolvement. The DoD 5000 series does not requirean analysis of alternatives for drug developmentefforts because they are not typically major defense647