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Vaccines - Vaccine Ethics

The supplier of the anthrax vaccine in the united states is now BioPort -- formerly the Michigan Biologic Products Institute (MBPI) run by the Michigan Department of Public Health. Persistent quality control problems have plagued the manufacturers as evidenced by a series of FDA inspection reports over the past 5 years. Citations include grossly inadequate standardization and testing and placing lots that failed testing into use. The sale of MBPI to BioPort Corp, a firm directed by former chairman of the Joint Chiefs of Staff Admiral Crowe, was declared in July 1998. This raises several ethical questions.

• According to military regulations a serviceperson must accept standard medical treatment or face court-martial. Anthrax vaccination is not a standard treatment, yet reprisals have been issued to service individuals who have refused vaccination
  
• there are suspicsions that the FDA's oversight of the troubled MBPI was due to Department of Defense concerns
  
• Military recordkeeping doesn't comply with civilian guidelines. Records of anthrax vaccinations during the Gulf War don't exist
  
• Postmarketing surveillance must be performed to detect rare, adverse events associated with vaccination. No such surveillance occured at the time of the first large scale use of the vaccine in the Gulf War.

The department of defense in november of 1997 proposed a large vaccine initiative termed the Joint Vaccine Acquistion Program. Initial funding is at $321 million dollars and goal of the project is to develop 17 vaccines directed at biological warfare threats. The Department of Defense will be responsible for all aspects of the vaccine development process including taking them through the FDA and arranging the manufacturing and administration to military personnel (12).