In the Department of Defense: Gary Christopherson, Office of the Assistant Secretary of Defense (Health Affairs), organized a briefing for the RAND group involved in the Gulf War study in the fall of 1996. He also listened to a briefing of this study in October 1997 and made useful criticisms at that time. John Casciotti, Office of the General Counsel, DoD, was very generous with his time in two lengthy interviews. Ronald E. Clawson, Project Manager, Pharmaceutical Systems, U.S. Army Medical Materiel Development Activity, organized a half-day meeting with his senior staff in spring 1997 to explain pyridostigmine bromide and botulinum toxoid, provided useful background documents and organized a briefing in January 1998 for his staff. Edmund Howe, a physician and lawyer at the Uniformed Services University of Health Sciences, discussed the ethics of the Interim Rule in a 1997 interview.
In the Food and Drug Administration, Stuart Nightingale, Associate Commissioner for Health Affairs, and Brian Malkin, Office of Health Affairs, provided documents and arranged a meeting with Mary Pendergast, Deputy Commissioner; Robert Temple, Center for Drug Evaluation and Research; and Karen Goldenthal, Center for Biologics Evaluation and Research.
In addition, Charles McCarthy, former director, Office for the Protection of Research Risks, Department of Health and Human Services, in a lengthy telephone interview, recalled the discussion that occurred in the fall of 1990 associated with the Interim Rule. Joan Porter, professional staff of the Presidential Advisory Committee on Gulf War Veterans' Illnesses, was helpful in several interviews, in providing useful background information, and in arranging an interview with Robyn Nishimi, Staff Director of the committee.
The two reviewers of this report made helpful criticisms that improved the final product. I take full responsibility for any remaining problems of fact or interpretation.