Page      Forward ......................................................III   I. Introduction .................................................  1  II. Background ...................................................  3       A. Codes, declarations, and laws governing human           experimentation .........................................  3       B. Mustard gas and lewisite .................................  5       C. Seventh-Day Adventists ...................................  5       D. Dugway Proving Ground ....................................  6       E. Radiation  exposure ......................................  7       F. Hallucinogens ............................................  9       G. Investigational  drugs ................................... 10 III. Findings and conclusions  .................................... 15       A. For at least 50 years, DOD has intentionally           exposed military personnel to potentially           dangerous substances, often in secret ................... 15       B. DOD has repeatedly failed to comply with required           ethical standards when using human subjects in           military research during war or threat of war ........... 18       C. DOD incorrectly claims that since their goal was           treatment, the use of investigational drugs in           the Persian Gulf War was not research ................... 24       D. DOD used investigational drugs in the Persian Gulf           War in ways that were not effective ..................... 25       E. DOD did not know whether pyridostigmine bromide           would be safe for use by U.S. troops in the           Persian Gulf War ........................................ 28       F. When U.S. troops were sent to the Persian Gulf           in 1994, DOD still did not have proof that           pyridostigmine bromide was safe for use as an           antidote enhancer ....................................... 31       G. Pyridostigmine may be more dangerous in combination           with pesticides and other exposures ..................... 32       H. The safety of the botulism vaccine was not           established prior to the Persian Gulf War ............... 34       I. Records of anthrax vaccinations are not suitable           to evaluate safety ...................................... 35       J. Army regulations exempt informed consent for           volunteers in some types of military research ........... 35       K. DOD and DVA have repeatedly failed to provide           information and medical followup to those who           participate in military research or are ordered           to take investigational drugs ........................... 36       L. The Federal Government has failed to support           scientific studies that provide information about           the reproductive problems experienced by veterans           who were intentionally exposed to potentially           dangerous substances .................................... 37       M. The Federal Government has failed to support           scientific studies that provide timely information           for compensation decisions regarding military           personnel who were harmed by various exposures .......... 38       N. Participation in military research is rarely           included in military medical records, making it           impossible to support a veteran's claim for service           connected disabilities from military research ........... 39       O. DOD has demonstrated a pattern of misrepresenting the danger           of various military exposures that continues today ...... 40  IV. Recommendations .............................................. 42       A. Congress should deny the DOD request for a blanket           waiver to use investigational drugs in case of war           or threat of war ........................................ 42       B. FDA should reject any applications from DOD that           do not include data on women, and long-term           followup data ........................................... 42       C. Congress should authorize a centralized database           for all federally funded experiments that utilize           human subjects .......................................... 43       D. Congress should mandate all Federal agencies to           declassify most documents on research involving           human subjects .......................................... 43       E. Congress should reestablish a National Commission           for the Protection of Human Subjects .................... 43       F. VA and DOD should implement regular site visits           to review Institutional Review Boards ................... 44       G. The Feres Doctrine should not be applied for           military personnel who are harmed by inappropriate           human experimentation when informed consent has not           been given .............................................. 44 Appendix    Survey of 150 Persian Gulf War Veterans ........................ 46

 

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