The 1994 Rockefeller Report Examining Biological Experimentation on U.S. Military

Recommendations

IV. STAFF RECOMMENDATIONS

A. FDA SHOULD DENY THE DEPARTMENT OF DEFENSE REQUEST FOR A “BLANKET WAIVER” TO USE INVESTIGATIONAL DRUGS WITHOUT INFORMED CONSENT IN CASE OF WAR OR THREAT OF WAR.

If investigational drugs are deemed necessary for protection or treatment, a waiver of informed consent should be sought only on a case-by- case basis. While the military might order individuals to take an investigational drug or use an investigational device if it is clearly safe and potentially efficacious, under no circumstances should the DOD fail to inform individuals about the known short-term and long-term risks prior to its administration.

In 1990, DOD applied to FDA for a waiver of informed consent, claiming they would provide warnings orally and in writing regarding the risks of pyridostigmine, even though they would not give soldiers the choice of whether or not to take it. According to reports from various sources, including DOD’s own study, DOD did not fulfill its promise. In addition, DOD personnel apparently distributed these drugs to civilians without any warnings. These failures and broken promises should be sufficient to persuade FDA to reject the DOD request for a blanket waiver, and should be taken into consideration any time DOD applies for a waiver of informed consent. In addition, FDA should investigate these problems and work with DOD to prevent similar problems in the future.

In addition, third-party or “deferred” consent should not be considered unless the individual receiving the drug is physically or mentally incompetent to make an informed decision on his/her behalf. If the DOD fails to obtain the necessary waivers, or fails to adequately inform those receiving the investigational products, DOD should be required to provide a written explanation to the appropriate congressional committees.

B. FDA SHOULD REJECT IND AND NDA APPLICATIONS FROM DOD THAT DO NOT INCLUDE DATA ON WOMEN AND LONG-TERM FOLLOWUP DATA.

When DOD submits an IND (investigational new drug) application or NDA (new drug application) to FDA for any product that they plan to use, they should always be required to include women in their research, since it is likely that the product will be used by women. On the basis of that requirement, FDA should reject the currently pending NDA for pyridostigmine’s use as an antidote enhancer, which was submitted to FDA in early 1994.

At a Senate briefing in November 1994, Dr. Ruth Merkatz, FDA’s Associate Commissioner for Women’s Health, stated that FDA will always require data on women in future drug approval applications, if the product under review is intended for use by women. However, Dr. Merkatz was not specific about whether this policy would apply to DOD.

In addition to data on women, it is increasingly clear that drugs can have long-term adverse reactions that are not immediately obvious. Given the responsibility of the Federal Government to provide medical care to veterans who were harmed during military service, DOD and FDA need to ensure that the VA and the public are aware of any potential long-term adverse reactions of any medical products that are given to military personnel.

In the case of pyridostigmine, a drug that DOD wants to have the authority to use in future conflicts in the Persian Gulf and elsewhere, FDA should immediately urge DOD to conduct the kinds of research that is needed to prove its safety for future military use, including research on its potentially toxic effects when combined with insecticides and other chemical agents that are commonly used by military personnel.

C. CONGRESS SHOULD AUTHORIZE A CENTRALIZED DATABASE FOR ALL FEDERALLY FUNDED EXPERIMENTS THAT UTILIZE HUMAN SUBJECTS.

Currently, the U.S. Department of Agriculture maintains a database which can identify the number of research grants awarded for studying various species, such as beef and dairy cattle, poultry, sheep, swine, and others. (Note 166) However, a database which identifies the types of human subjects does not exist.

Congress should authorize a database which would provide crucial information on federally funded research utilizing human subjects. Included in this database should be the amount of Federal dollars spent on various research efforts and the type of human subjects utilized, such as women, minorities, children, prisoners, military personnel, and others.

Annual reports from the data collected should be provided to Congress. Such information would enable legislators to understand better the use of human subjects in federally sponsored research.

D. CONGRESS SHOULD MANDATE ALL FEDERAL AGENCIES TO DECLASSIFY MOST DOCUMENTS ON RESEARCH INVOLVING HUMAN SUBJECTS.

Information involving human subjects in military research, which remains classified for purported reasons of national security, needs to be reevaluated and declassified whenever possible. All Federal agencies should scrutinize classified information and make information available which might benefit individuals who participated in such research.

E. CONGRESS SHOULD REESTABLISH A NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS, WITHOUT A TERM LIMIT, WHICH HAS THE AUTHORITY TO INVESTIGATE POTENTIAL VIOLATIONS OF HUMANS SUBJECTS’ RIGHTS IN FEDERALLY FUNDED RESEARCH.

A National Commission should standardize Federal regulations (45 CFR 46), and consider adding military personnel as a vulnerable population. Policies for the conduct of research in war or for the purposes of national security should receive greater public debate. No existing regulations governing military personnel should be finalized without such public dialogue.

Congress should provide authorization and appropriations for the National Commission, and require annual reports on potential violations of human subjects’ rights. The administrative body of the Commission should consist of nine members, three appointed by the majority party in Congress, three appointed by the minority party in Congress, and three appointed by the executive branch.

F. THE DEPARTMENT OF VETERANS AFFAIRS AND THE DEPARTMENT OF DEFENSE SHOULD IMPLEMENT REGULAR SITE VISITS TO REVIEW THE PERFORMANCE OF INSTITUTIONAL REVIEW BOARDS.

DOD and VA authorized site visits should include an evaluation of military and VA research onsite, and a random sample review of actual research and medical records, interviews with human subjects, and signed consent forms to assure investigator compliance. A mechanism should be in place whereby human subjects can express concern over perceived or actual violations of the informed consent contract. This mechanism should allow human subjects to register complaints to a regulatory agency and the National Commission, rather than solely the investigator of the research project. All military personnel and veterans involved in research should receive a copy of the “Experimental Subject’s Bill of Rights.” (Note 167)

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.

The U.S. Supreme Court has interpreted the Feres Doctrine to mean that soldiers “injured in the course of activity incident to service” may not sue the Government for compensation. (Note 168) However, when inappropriate experimentation has resulted in suffering for military personnel, this interpretation stands in violation of established ethical standards, including the Nuremberg Code, the Declaration of Helsinki, and the “Common Rule.” Congress should not apply the Feres Doctrine for military personnel who are harmed by inappropriate experimentation when informed consent has not been given.

The U.S. Supreme Court mentioned the Nuremberg Code in United States v. Stanley in 1987. James Stanley, an Army serviceman, volunteered to test the effectiveness of protective clothing and equipment against chemical warfare in February 1958. (Note 169) In the process, he unknowingly received LSD as part of an Army study to determine the effects of the drug on humans. Although Stanley suffered from periods of incoherence and memory loss for years, he only learned in 1975 that he had participated in the LSD study when the Army solicited his cooperation in a followup study. Having been denied compensation for injury by the Army, Stanley filed under the Federal Tort Claims Act. Justice Antonin Scalia wrote the opinion for the Court, split 5 to 4. (Note 170) Justice Scalia wrote that permitting Stanley to sue the Army would disrupt the Army itself and “would call into question military discipline and decision-making.” However, Justice Sandra Day O’Connor, writing for herself as one of the dissenting judges, stated that the Feres doctrine bar:

“surely cannot insulate defendants from liability for deliberate and calculated exposure of otherwise healthy military personnel to medical experimentation without their consent, outside of any combat, combat training, or military exigency…” (Note 171)

Justice O’Connor also commented on the Nuremberg Code in her writing, stating that voluntary consent of the human subject is absolutely essential, even for the U.S. military. It was, after all, the U.S. military who played an instrumental role in the criminal prosecution of the Nazi officials who experimented with human beings during World War II.

Appendix

Survey of 150 Persian Gulf War Veterans

Male respondents: 120 [80%] Female respondents: 30 [20%]

Active duty servicemembers: 46 [31%] Retired: 4 [3%] Temporarily disabled retirement list: 2 [1%] Active reservists: 46 [31%]

Veteran: 15 [10%] Individual ready reserves: 10 [7%] National Guard: 27 [18%] Those ill since returning from Gulf: 136 [91%] Those who had ill family members: 60 [40%]

Those who identified at least one investigational drug that they took: 75 [50%]

ANTHRAX–
Number of respondents who received anthrax: 68 [45%] 1 vaccination: 31 [46% of those who received anthrax] 2 vaccinations: 31 [46%] 3 vaccinations: 2 [ 3%] Unknown number: 4 [ 6%] Of those receiving anthrax vaccinations, those who:
received no oral or written information about the vaccine: 61 [90%] were told they could not refuse it: 58 [85%] described immediate side effects: 29 [43%]

Of the women receiving anthrax vaccination, those who received no warning on risk if pregnant: 12/16 [75%]

BOTULINUM TOXOID–
Number of respondents who received botulinum toxoid: 17
1 vaccination: 10 [59% of those who received botulinum toxoid] 2 vaccinations: 3 [18%] Unknown number: 4 [24%]

Of those receiving botulinum toxoid, those who:
received no oral or written information about the vaccine: 13 [76%] were told they could not refuse it: 15 [88%] described immediate side effects: 6 [35%] Of the women receiving botulinum toxoid, those who received no warning on risk if pregnant: 4/4 [100%]

PYRIDOSTIGMINE BROMIDE–
Number of respondents who took pyridostigmine bromide: 73 [49%] Of those taking pyridostigmine bromide, those who:
received no oral or written information on side effects: 63 [86%] were told they could not refuse it: 54 [74%] described immediate side effects: 38 [52%] did not comply and take drugs when they were supposed to: 14 [19%] Of the women receiving pyridostigmine bromide, those who received no warning on risk if pregnant: 14/18 [78%]

OTHER SURVEY INFORMATION–
Number of respondents who received a vaccination but did not know what it was: 25 [17%]

Number of respondents who received a drug but did not know what it was: 28 [19%] Number of respondents who have not received any information following the Persian Gulf War concerning investigational drugs from either VA or DOD: 128 [85%]

Concerning medical records:
Medical record is incomplete/inaccurate: 48 [32%] Medical record [part or all] is missing/lost: 28 [19%]

25 MOST COMMON SYMPTOMS REPORTED
[number of respondents reporting]

Fatigue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  65
Skin problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  61
   rashes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  50
Memory loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  59
   blackouts, forgets where they are  . . . . . . . . . . . . . . . . . . 5
Joint pain  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  55
Headaches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  52
Personality changes . . . . . . . . . . . . . . . . . . . . . . . . . .  44
Diarrhea  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  32
Muscle pain, weakness, spasms, tremors  . . . . . . . . . . . . . . . .  29
Pain [back, shoulder, neck, etc]  . . . . . . . . . . . . . . . . . . .  28
Trouble with vision . . . . . . . . . . . . . . . . . . . . . . . . . .  24
Shortness of breath . . . . . . . . . . . . . . . . . . . . . . . . . .  22
Sleep disturbances  . . . . . . . . . . . . . . . . . . . . . . . . . .  22
Hair loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  19
Numbness [hands, fingers, feet] . . . . . . . . . . . . . . . . . . . .  19
Dental problems/bleeding gums . . . . . . . . . . . . . . . . . . . . .  18
Reproductive problems . . . . . . . . . . . . . . . . . . . . . . . . .  18
Bleeding  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  16
Sores . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  14
Chest problems [pain] . . . . . . . . . . . . . . . . . . . . . . . . .  12
Abdominal/stomach pain  . . . . . . . . . . . . . . . . . . . . . . . .  12
Fever . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  10
Nausea/vomiting . . . . . . . . . . . . . . . . . . . . . . . . . . . .  10
Dizziness/staggering  . . . . . . . . . . . . . . . . . . . . . . . . .  10
Sinus, nasal discharge  . . . . . . . . . . . . . . . . . . . . . . . . . 9
Sensitivity to light, smell, noise  . . . . . . . . . . . . . . . . . . . 9
Children born with birth defects  . . . . . . . . . . . . . . . . . . . . 7
Partners with reproductive problems . . . . . . . . . . . . . . . . . .  16

NOTES

• 1.Veterans at Risk: The Health Effects of Mustard Gas and Lewisite, Pechura, C.M. & Rall, D.P. (Eds.) Institute of Medicine, National Academy Press, Washington, DC, 1993, p. 65.
• 2.In a survey of 150 Persian Gulf War veterans conducted by Committee staff, 15 of 17 military personnel receiving botulinum toxoid in the Gulf war were told they could not refuse the vaccination; 54 of 73 military personnel receiving pyridostigmine were told they could not refuse the drug.
• 4.Testimony of Deanne Siemer, general counsel, Department of Defense, hearing before the Subcommittee on Health and Scientific Research, Committee on Human Resources, U.S. Senate, “Human Testing by the CIA, 1977,” September 20-21, 1977, pp. 157-168.
• 5.Testimony of Sidney Gottlieb, M.D., former CIA agent, hearing before the Subcommittee on Health and Scientific Research, Committee on Human Resources, U.S. Senate, “Human Drug Testing by the CIA, 1977,” September 20-21, 1977, pp. 169-217.
• 6.The Nuremberg Code, from Trials of War Criminals before the Nuremberg Military Tribunals, U.S. Government Printing Office, Washington, DC, 1948.
• 7.55 Federal Register 52,814-52,817 (December 21, 1990), “Informed Consent for Human Drugs and Biologics: Determinations that Informed Consent is Not Feasible.”
• 8.Declaration of Helsinki, in European and Nordic Regulations and Guidelines for Good Clinical Practice, Pharmaco Dynamics Research, Inc., July 1990.
  

  The Declaration of Helsinki was amended at the Twenty-Ninth World Medical Assembly held in Tokyo, Japan, in 1975, the Thirty-Fifth World Medical Assembly held in Venice, Italy, in 1983, and the Forty-First World Medical Assembly held in Hong Kong in 1989.

• 9.Declaration of Helsinki, World Medical Association, in Biomedical Ethics, Third Edition, Mappes, T.A. & Zembaty, J.S., McGraw-Hill, Inc., 1991, pp. 211-213.
• 10.56 Federal Register 28,002-28,032 (June 18, 1991), “Federal Policy for the Protection of Human Subjects.”
• 11.”Research Involving Human Subjects,” statement of Robyn Y. Nishimi, Ph.D., Office of Technology Assessment, hearing before the Subcommittee on Energy, Committee on Science, Space, and Technology, U.S. House of Representatives, “Human Radiation, Experimentation, and Gene Therapy,” February 10, 1994.
• 12.45 CFR 46 (Public Welfare), subparts B,C, and D, revised October 1, 1991.
• 13.10 U.S.C. (Armed Forces) and 32 U.S.C. 980 (National Guard) put limits on the use of humans as experimental subjects.
• 14.Veterans at Risk, op. cit., pp. 3-4, 6-8, 50-52, 224-226.
• 15.Ibid., p. 65.
• 16.Ibid., p. 7.
• 17.59 Federal Register 41,497-42,500 (August 18, 1994), “Claims Based on Chronic Effects of Exposure to Vesicant Agents.”
• 18.Gene Wars, Military Control Over the New Genetic Technologies, Piller, C. & Yamamoto, K.R., Beech Tree Books, William Morrow, New York, 1988, pp 44-45, 53.
• 19.Ibid.
• 20.Ibid.
• 21.At least one Seventh-Day Adventist Church has held reunions of those human subjects who participated in Operation Whitecoat. (Phone interview by Committee staff with Dr. Frank Damazo, Frederick, MD, March 21, 1994.)
• 22.Hearing before the Subcommittee on Conservation and Natural Resources, Committee on Government Operations, U.S. House of Representatives, “Environmental Dangers of Open-Air Testing of Lethal Chemicals,” May 20-21, 1969.
• 23.Ibid., pp. 6-7.
• 24.Testimony of Dr. D.A. Osguthorpe, veterinarian and consultant to Utah State Department of Agriculture, hearing before the Subcommittee on Conservation and Natural Resources, Committee on Government Operations, U.S. House of Representatives, “Environmental Dangers of Open-Air Testing of Lethal Chemicals,” May 20-21, 1969, pp 63-66.
• 25.Ibid., pp. 64-65.
• 26.Testimony of Hon. Richard D. McCarthy, a Representative in Congress from the State of New York, hearing before the Subcommittee on Conservation and Natural Resources, Committee on Government Operations, U.S. House of Representatives, “Environmental Dangers of Open-Air Testing of Lethal Chemicals,” May 20-21, 1969, pp 6-7.
• 27.Cole, L.A., “Risk and biological defense program,” Physicians for Social Responsibility Quarterly, Vol 2, No. 1, March 1992, pp. 40-50.
• 28.Compilation of Local Fallout Data From Test Detonations 1945-1962, extracted From DASA 1251, Vol I-Oceanic U.S. Tests, Contract No. DNA 001- 79-C-0081, May 1, 1979, sponsored by the Defense Nuclear Agency.
• 29.Ibid.
• 30.Secret document, Department of Defense, Research and Development Board, Committee on Medical Sciences, Joint Panel on the Medical Aspects of Atomic Warfare, 8th Meeting, Washington, DC, February 24, 1951.
• 31.”Health Effects of Exposure to Low Levels of Ionizing Radiation,” BEIR V, National Research Council, National Academy Press, Washington, DC, 1990.
• 32.Letter from Hon. Jesse Brown, Secretary of Veterans Affairs, to Sen. John D. Rockefeller IV, Chair, Senate Committee on Veterans’ Affairs, May 31, 1994.
• 33.News release, Office of Public Affairs, Department of Veterans Affairs, Washington, DC, October 11, 1994.
• 34.”Nuclear Health and Safety, Examples of Post World War II Radiation Releases at U.S. Nuclear Sites,” U.S. General Accounting Office, November 1993, GAO/RCED-94-51FS.
• 35.Information from the Office of the Assistant Secretary for Congressional Affairs, Department of Veterans Affairs, received at the Senate Committee on Veterans’ Affairs, September 21, 1994; in Committee files.
• 36.Letter from Hon. Jesse Brown, Secretary of Veterans Affairs, to Sen. John D. Rockefeller IV, Chair, U.S. Senate Committee on Veterans’ Affairs, May 26, 1994.
• 37.Gene Wars, op. cit., pp 50-51.
• 38.Statement of David Gries, Director, Center for the Study of Human Intelligence, CIA, hearing before the Subcommittee on Administrative Law and Governmental Relations, Committee on the Judiciary, U.S. House of Representatives, “Government-Sponsored Tests on Humans and Possible Compensation for People Harmed in the Tests,” February 2, 1994.
• 39.Summary of testimony, Lloyd B. Gamble, LSD test subject, hearing before the Subcommittee on Administrative Law and Governmental Relations, Committee on the Judiciary, U.S. House of Representatives, “Government- Sponsored Tests on Humans and Possible Compensation for People Harmed in the Tests,” February 2, 1994.
• 40.Ibid.
• 41.Testimony of Sidney Gottlieb, M.D., former CIA agent, before the Subcommittee on Health and Scientific Research, Committee on Human Resources, U.S. Senate, “Human Drug Testing by the CIA, 1977,” September 20-21, 1977, p. 169. Actual wording is “convert means,” which we took to mean “covert means.”
• 42.Ibid., pp. 169-217.
• 43.55 Federal Register 52,814-52,817 (December 21, 1990).
• 44.Sidell, F.R., “Clinical Considerations in Nerve Agent Intoxication,” Chemical Warfare Agents, Somani, S.M. (Ed.), Academic Press, Inc., 1992, pp. 155-194.
• 45.Ibid.
• 46.Ibid.
• 47.Ibid.
• 48.Ibid.
• 49.Das Gupta, S., Bass, K.N., Warnick, J.E. “Interaction of reversible and irreversible cholinesterase inhibitors on the monosynaptic reflex in neonatal rats,” Toxicology and Applied Pharmacology, Vol. 99, 1989, pp. 28- 36.
• 50.55 Federal Register 52,814-52,817 (December 21, 1990).
• 51.Drachman, D.B. “Medical Progress, review article: Myasthenia gravis,” New England Journal of Medicine, Vol. 330, No. 5, June 23, 1994, pp. 1797- 1810.
• 52.Scadding, G.K., Havard, C.W.H., Lange, M.J., & Domb, I. “The long term experience of thymectomy for myasthenia gravis,” Journal of Neurology, Neurosurgery, and Psychiatry, Vol. 48, 1985, pp. 401-406.
• 53.Wacks, I., Oster, J.R., Perez, G.O., & Kett, D.H. “Spurious hyperchloremia and hyperbicarbonatemia in a patient receiving pyridostigmine bromide therapy for myasthenia gravis,” American Journal of Kidney Diseases, Vol. XVI, No. 1, July 1990, pp. 76-79.
• 54.Ibid.
• 55.Mestinon is the brand name for one form of pyridostigmine bromide available in the United States.
• 56.Minutes of meeting of the Informed Consent Waiver Review Group (ICWRG), Food and Drug Administration, December 31, 1990.
• 57.Ellis, R.J. Immunobiologic agents and drugs available from the Centers for Disease Control: Descriptions, recommendations, adverse reactions, and serologic response. Third Edition. Centers for Disease Control, Public Health Service, U.S. Department of Health and Human Services, Atlanta, GA, March 1982.
• 58.Middlebrook, J.L. “Contributions of the U.S. Army to Botulinum Toxin Research,” Botulinum and Tetanus Neurotoxins, Das Gupta, B.R., (Ed.), Plenum Press, New York, 1993, pp. 515-519.
• 59.Informational material for the use of pentavalent (ABCDE) botulinum toxoid aluminum phosphate adsorbed, Protocol #392, Centers for Disease Control, Public Health Service, U.S. Department of Health and Human Services, May 1992.
• 60.Review by Ann Sutton to the IND record, November 14, 1990; in Committee files.
• 61.Informational material for the use of anthrax vaccine adsorbed, Michigan Department of Public Health, U.S. License No. 99, 1978.
• 62.Friedlander, A.M., Welkos, S.L., Pitt, M.L.M., et al. “Postexposure prophylaxis against experimental inhalation anthrax,” Journal of Infectious Diseases, Vol. 167, 1993, pp. 1239-1242.
• 63.Anthrax vaccine adsorbed, package insert, Michigan Department of Public Health, Lansing, MI, 1978.
• 64.”Summary of the issues impacting upon the health of Persian Gulf War veterans,” Version 1.1, March 3, 1994.
• 65.”Human Experimentation, An Overview on Cold War Era Programs,” U.S. General Accounting Office, September 28, 1994, GAO/T-NSIAD-94-266.
• 66.Ibid.
• 67.Veterans at Risk, op. cit., pp. 7-8.
• 68.Statement of Rudolph R. Mills, hearing before the Committee on Veterans’ Affairs, U.S. Senate, “Is Military Research Hazardous to Veterans’ Health? Lessons from World War II, the Persian Gulf War, and Today,” May 6, 1994; hereinafter referred to as Hearing, May 6, 1994.
• 69.Ibid.
• 70.Hearing, May 6, 1994; John T. Harrison, written statement submitted for the record.
• 71.Although the study was published in the Journal of the American Medical Association, these results were not reported in the published article. They are reported in an unpublished report, Survey #1, Food and Drug Administration IND 23,509, Operation Desert Storm/Shield, May 27, 1992.
• 72.The Nuremberg Code, op. cit.
• 73.”Annas, G.J. & Grodin, M.A. “The Nazi Doctors and the Nuremberg Code,” Human Rights in Human Experimentation, Oxford University Press, 1992, p 152.
• 74.Hearing, May 6, 1994; Nathan J. Schnurman, written statement submitted for the record.
• 75.Testimony of Nathan Schnurman, WWII veteran, mustard gas test subject, hearing before the Subcommittee on Administrative Law and Governmental Relations, Committee on the Judiciary, U.S. House of Representatives, “Government-Sponsored Tests on Humans and Possible Compensation for People Harmed in the Tests,” February 2, 1994.
• 76.Hearing, May 6, 1994; John William Allen, written statement submitted for the record.
• 77.Pyridostigmine is approved by the FDA at a one-time dosage of 15 mg to reverse the effects of certain drugs given during anesthesia.
• 78.55 Federal Register 52,814-52,817 (December 21, 1990).
• 79.Memorandum for Record, August 30, 1990, submitted by Craig R. Lehmann, Lt. Col., USAF, BSC; in Committee files.
• 80.FDA memorandum from Richard Klein and Ann Graham to Stuart Nightingale, September 7, 1990; in Committee files.
• 81.Draft of minutes, meeting between officials of DOD and FDA, December 31, 1990, provided by FDA to Committee; in Committee files.
• 82.Ibid.
• 83.55 Federal Register 52,814-52,817 (December 21, 1990).
• 84.Letter in Committee files.
• 85.Letter from Enrique Mendez, Jr., M.D., to David Kessler, M.D., Commissioner, Food and Drug Administration, March 15, 1991; in Committee files.
• 86.Survey #1, Food and Drug Administration IND 23,509, Operation Desert Storm/Shield, May 27, 1992.
• 87.Response to Committee survey completed by Carol Picou, Persian Gulf War nurse; in Committee files.
• 88.Hearing, May 6, 1994; statement of Neil Tetzlaff, Persian Gulf War veteran.
• 89.Memoranda describing phone conversations with journalists are in Committee files.
• 90.Letters, summaries of phone conversations, and supporting documents are in Committee files. These include an “Aircrew Symptoms Checklist on AF Form 1666 (TEST) FEB 86, which instructs the pilots to “[t]ake one (1) pyridostigmine bromide tablet (30 mg) every eight (8) hours over a 24 hour period.”
• 91.One of the men has provided records of these studies to the Committee; although the records specify that all pilots participating in the study were removed from flight status and given informed consent about the risks of pyridostigmine, those records are not consistent with the descriptions of the study provided by the pilots who contacted the Committee. Moreover, the records themselves do not include an informed consent form or information about the risks of pyridostigmine.
• 92.Letter and medical records of Craig Crane are in Committee files.
• 93.Hearing, May 6, 1994; statement of Dr. Edward Martin, Acting Principal Assistant Secretary of Defense for Health Affairs.
• 94.Letter from John M. Bachkosky, Deputy Director, Office of the Director of Defense Research and Engineering, U.S. Department of Defense, to Sen. John D. Rockefeller IV, Chair, Senate Committee on Veterans’ Affairs, May 19, 1994.
• 95.Letter from John Deutch, Deputy Secretary of Defense, to Sen. John D. Rockefeller IV, Chair, Senate Committee on Veterans’ Affairs, November 17, 1994; in Committee files.
• 96.Hearing, May 6, 1994; statement of Arthur Caplan, Ph.D. Dr. Caplan is now Director of the Center of Biomedical Ethics at the University of Pennsylvania.\
• 97.Minutes, Meeting (July 27, 1992) on Finalizing Interim Rule on Waiver of Informed Consent, signed July 28, 1992, by William H. Habig.
• 98.Koplovitz, I., Harris, L.W., Anderson, D.R., Lennox, W.J., & Stewart, J.R. “Reduction by pyridostigmine pretreatment of the efficacy of atropine and 2-PAM treatment of sarin and VX poisoning in rodents,” Fundamental and Applied Toxicology, Vol. 18, 1992, pp. 102-106.
• 99.Sidell, F.R., op. cit.
• 100.”Summary of the issues impacting upon the health of the Persian Gulf veterans,” Version 1.1: March 3, 1994.
• 101.The actual data from this study was not provided to our Committee, and apparently not provided to FDA either.
• 102.IND Amendment, Reference to IND# 28480, March 28, 1988, Letter from Thomas H. Gray, Chief, Operational Unit Training Branch, Department of the Air Force, to Mr. David Banks, Consumer Safety Officer, FDA.
• 103.Answers from the Department of Defense to followup questions submitted by Sen. John D. Rockefeller IV, after the Committee’s May 6, 1994, hearing. The answers were received by the Committee on September 19, 1994.
• 104.A 150-pound man weighs 68 kg; 68 x 0.4 = 27 mg.
• 105.Sidell, F.R., op. cit.
• 106.The administration of additional atropine some hours after exposure to chemical weapons might have been helpful, but it is not clear how many soldiers would have been fortunate enough to receive medical treatment within hours of combat, or how effective that later treatment would have been.
• 107.Minutes of Meeting of the Informed Consent Waiver Review Group (ICWRG), Food and Drug Administration, December 31, 1990.
• 108.In a letter dated July 27, 1992, FDA asked whether an IND should be required to test the anthrax vaccine against aerosolized anthrax.
• 109.Department of Defense briefing with staff of the Senate Committee on Veterans’ Affairs, 414 Russell Senate Office Building, April 20, 1994.
• 110.A list of many of these studies is in Appendix A.
• 111.Barbarino, A., Corsello, S.M., Tofani, A., et al. “Sexual dimorphism of pyridostigmine potentiation of growth hormone (GH)-releasing hormone- induced GH release in humans,” Journal of Clinical Endocrinology and Metabolism, Vol. 73, No. 1, 1991, pp. 75-78.
• 112.O’Keane V. & Dinan, T.G. “Sex steroid priming effects on growth hormone response to pyridostigmine throughout the menstrual cycle,” Journal of Clinical Endocrinology and Metabolism, Vol. 75, No. 1, 1992, pp. 11-14.
• 113.Ibid.
• 114.These instructions are consistent over time, and were included in many different studies between 1985-90. Copies are in Committee files.
• 115.IND Amendment, 28 March 1988, IND 28,480.
• 116.IND Annual Report, 1987-1988, IND 23,509.
• 117.DAMD17-85-C-5133, Task Order 2, Kornhauser.
• 118.Israeli Journal of Medical Science, Vol. 27, 1991, pp. 659-663.
• 119.Keeler, J.R., Hurst, C.G., & Dunn, M.A. “Pyridostigmine used as a nerve agent pretreatment under wartime conditions,” Journal of the American Medical Association, Vol. 266, No. 5, 1991, pp. 693-695.
• 120.Letter from the author of the published research, Dr. Thomas Tiedt, to Sen. John D. Rockefeller IV, Chair, Senate Committee on Veterans’ Affairs, June 8, 1994; in Committee files.
• 121.Abbreviated Protocol, signed by Roger W. Wiley and Darcelle Delrie, and other documents regarding “The Effects of Pyridostigmine Bromide on Vision”; attached to a cover letter from Martha H. Myers, Acting Chief, Human Use Review and Regulatory Affairs Office, Department of the Army, August 15, 1990. Documents are in Committee files.
• 122.There are several studies of the effects of a one-time dose of pyridostigmine on growth hormone in women, but the conditions of these studies, including fasting and use during one phase of the menstrual cycle, were not relevant to use of pyridostigmine in the Gulf War.
• 123.to Protocol HURC #378,” memorandum from William K. Prusaczyk, research physiologist, October 23, 1989; in Committee files.
• 124.Sharabi, Y., Danon, Y., Berkenstadt, H., et al., “Survey of symptoms following intake of pyridostigmine during the Persian Gulf War,” Israeli Journal of Medical Science, Vol. 27, 1991, pp. 656-658.
• 125.Information amendment from the Department of the Army to FDA, IND 23509-pyridostigmine bromide-WR 270,710, May 27, 1992.
• 126.Keeler, J.R., et al., op. cit.
• 127.Ibid.
• 128.Barbarino, A., et al., op. cit.
• 129.All the men and women in the study were between 19-25 years old, were free of other medications, and were fasting; the women were all in the luteal phase of their menstrual cycle.
• 130.Although the DOD does plan to follow up on research on pyridostigmine and DEET conducted by Dr. James Moss (previously with the Agricultural Research Service, USDA) by conducting a study of rats, that research has not yet been initiated. Dr. Moss’ research is described in the next section of this report.
• 131.M.A. & Stephenson, L.A. “Cardiovascular and thermoregulatory responses to repeated anticholinesterase administration,” Journal of Thermal Biology, Vol. 17, No. 6, pp. 333-337.
• 132.Hearing, May 6, 1994; testimony of James Moss, Ph.D., researcher, Agricultural Research Service, U.S. Department of Agriculture, Gainesville, FL.
• 133.Additional information about his results are provided in Dr. Moss’ answers to Sen. Rockefeller’s posthearing questions, included in the transcript of the Committee’s May 6, 1994, hearing, and in documents provided by Dr. Moss which are in the Committee files.
• 134.”U.S. Chemical and Biological Warfare-related Dual Use Exports to Iraq and Their Possible Impact of the Health Consequences of the Persian Gulf War,” a report of Sen. Donald W. Riegle, Jr., Chair, and Sen. Alfonse M. D’Amato, ranking Republican member, U.S. Senate Committee on Banking, Housing, and Urban Affairs, May 25, 1994.
• 135.List of pesticides procured during Desert Shield/Storm (acquired through the Federal supply system), information submitted to the Senate Committee on Veterans’ Affairs, April 6, 1994, from the Department of the Army, Office of the Surgeon General.
• 136.Hearing, May 6, 1994; document submitted for the record.
• 137.Correspondence between Secretary Espy and Senator Rockefeller are in Committee files.
• 138.Hearing, May 6, 1994; document submitted for the record by Craig Crane.
• 139.Minutes of Meeting of the Informed Consent Waiver Review Group (ICWRG), Food and Drug Administration, December 31, 1990.
• 140.BBIND 3723, Food and Drug Administration, memorandum from Lawrence A. D’Hoostelaere on “General safety testing of botulinum toxoid,” March 2, 1994.
• 141.Review by Ann Sutton, Vaccines and Allergenics, DBIND, Food and Drug Administration, to the IND record, November 14, 1990.
• 142.Informational material for the use of pentavalent (ABCDE) botulinum toxoid aluminum phosphate adsorbed, U.S. Department of Health and Human Services, Centers for Disease Control, Atlanta, Georgia, Revised May 1982, protocol #392.
• 143.Briefing, Maj. Gen. Ron Blanck, Commanding General, Walter Reed Army Hospital, to Committee staff, 414 Russell Senate Office Building, Washington, DC, February 4, 1994.
• 144.Hearing, May 6, 1994, testimony of the Rev. Dr. Barry Walker, Persian Gulf War veteran.
• 145.Army Regulation 70-25, “Research and Development, Use of Volunteers as Subjects of Research,” Department of the Army, Washington, DC, March 26, 1968.
• 146.Letter from Sara E. Lister, Assistant Secretary of the Army, to Sen. John D. Rockefeller IV, Chair, Senate Committee on Veterans’ Affairs, June 15, 1994.
• 147.The two provisions described in this section are part of Public Law 103-446, the Veterans’ Benefits Improvement Act of 1994.
• 148.Veterans at Risk, op. cit.
• 149.Veterans and Agent Orange, Health Effects of Herbicides Used in Vietnam, Institute of Medicine, National Academy Press, Washington, DC, 1993.
• 150.News Release, Office of Public Affairs, Department of Veterans Affairs, Washington, DC, June 13, 1994.
• 151.”Health Effects of Exposure to Low Levels of Ionizing Radiation,” op. cit.
• 152.Hearing, May 6, 1994; prepared statement of Robert J. Temple, M.D., Director, Office of Drug Evaluation, Center for Drug Evaluation and Research, Food and Drug Administration.
• 153.Public Law 102-585, 706, November 4, 1992, Agreement with National Academy of Sciences for Review of Health Consequences of Service during the Persian Gulf War.
• 154.”It is likely that a great majority of ground personnel [in the Persian Gulf] received at least one dose and probably up to the full 21 tablets [of pyridostigmine] dispensed,” National Institutes of Health Technology Assessment Workshop, “The Persian Gulf Experience and Health,” final statement issued June 22, 1994, p. 10. The workshop was held April 27-29, 1994.
• 155.News Release, Office of Public Affairs, Department of Veterans Affairs, July 20, 1994.
• 156.B-257173, GAO letter to Senator John D. Rockefeller IV, Chair, Senate Committee of Veterans’ Affairs, on the location of veterans’ service medical records, May 4, 1994.
• 157.Hearing, May 6, 1994; testimony of Leonard A. Cole, Ph.D., professor, Rutgers University.
• 158.Ibid.
• 159.San Francisco Chronicle, December 22, 1976, page 1.
• 160.Cole, L.A. Clouds of Secrecy, The Army’s Germ Warfare Tests Over Populated Areas, Rowman and Littlefield, 1988, pp. 75-104.
• 161.Hearing, May 6, 1994; testimony of Earl P. Davenport, veteran and former employee, Dugway Proving Ground.
• 162.Memorandum of phone interview with Dr. Michael Vance, Good Samaritan Hospital, Phoenix, AZ, March 21, 1994; in Committee files.
• 163.”UMA Seeks Health and Safety Controls at Dugway,” Bulletin of the Utah Medical Society, May 1992, Vol. 40, No. 5, p. 1; “UMA Joins Lawsuit Against Army,” Bulletin of the Utah Medical Society, June 1992, Vol. 40, No. 6, p. 1; in Committee files.
• 164.Hearing, May 6, 1994; testimony of Dr. Cole.
• 165.Ibid.
• 166.Phone interview, Patrick Casula, Office of Grants and Program Systems, U.S. Department of Agriculture, October 12, 1994.
• 167.”Summary of Findings and Recommendations, Review of the Office of Health and Environmental Research Program, Protection of Human Research Subjects,” Subcommittee of the Health and Environmental Research Advisory Committee, U.S. Department of Energy, May 1994.
• 168.Annas, G.J. & Grodin, M.A. “The Nazi Doctors and the Nuremberg Code,” Human Rights in Human Experimentation, Oxford University Press, 1992, p. 209.
• 169.Ibid., pp. 212-214.
• 170.United States v. Stanley, 107 S. Ct. 3054 (1987), cited in “The Nazi Doctors and the Nuremberg Code,” Human Rights in Human Experimentation, Annas, G.J. & Grodin, M.A., Oxford University Press, 1992, pp. 212-214.
• 171.Ibid.

http://www.chemtrails911.com/docs/-%202007/Table%20of%20Contents%20Rockefeller%20Report.htm