63 Documents the Government Doesn't Want You to Read
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BEN NIGHTHORSE CAMPBELL, Colorado
Jim Gottlieb, Chief Counsel/Staff Director
John H. Moseman, Minority Staff Director/Chief Counsel
Diana M. Zuckerman, Professional Staff Member
Patricia Olson, Congressional Science Fellow
FOREWORD
U.S. Senate,
Committee on Veterans’ Affairs,
Washington, DC, December 8, 1994
During the last few years, the public has become aware of several examples where U.S. Government researchers intentionally exposed Americans to potentially dangerous substances without their knowledge or consent. The Senate Committee on Veterans’ Affairs, which I have been privileged to chair from 1993-94, has conducted a comprehensive analysis of the extent to which veterans participated in such research while they were serving in the U.S. military. This resulted in two hearings, on May 6, 1994, and August 5, 1994.
This report, written by the majority staff of the Committee, is the result of that comprehensive investigation, and is intended to provide information for future deliberations by the Congress. The findings and conclusions contained in this report are those of the majority staff and do not necessarily reflect the views of the members of the Committee on Veterans’ Affairs.
This report would not have been possible without the dedication and expertise of Dr. Patricia Olson, who, as a Congressional Science Fellow, worked tirelessly on this investigation and report, and the keen intelligence, energy, and commitment of Dr. Diana Zuckerman, who directed this effort.
John D. Rockefeller IV, Chairman
CONTENTS
I. Introduction
II. Background
• A. Codes, declarations, and laws governing human experimentation
• B. Mustard gas and lewisite
• C. Seventh-Day Adventists
• D. Dugway Proving Ground
• E. Radiation exposure
• F. Hallucinogens
• G. Investigational drugs
III. Findings and conclusions
• A. For at least 50 years, DOD has intentionally exposed military personnel to potentially dangerous substances, often in secret
• B. DOD has repeatedly failed to comply with required ethical standards when using human subjects in military research during war or threat of war
• http://www.gulfweb.org/bigdoc/dodC. DOD incorrectly claims that since their goal was treatment, the use of investigational drugs in the Persian Gulf War was not research
• D. DOD used investigational drugs in the Persian Gulf War in ways that were not effective
• E. DOD did not know whether pyridostigmine bromide would be safe for use by U.S. troops in the Persian Gulf War
• 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
• G. Pyridostigmine may be more dangerous in combination with pesticides and other exposures
• H. The safety of the botulism vaccine was not established prior to the Persian Gulf War
• I. Records of anthrax vaccinations are not suitable to evaluate safety
• J. Army regulations exempt informed consent for volunteers in some types of military research
• 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
• 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
• 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
• 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
• O. DOD has demonstrated a pattern of misrepresenting the danger of various military exposures that continues today
IV. Recommendations
• A. Congress should deny the DOD request for a blanket waiver to use investigational drugs in case of war or threat of war
• B. FDA should reject any applications from DOD that do not include data on women, and long-term followup data
• C. Congress should authorize a centralized database for all federally funded experiments that utilize human subjects
• D. Congress should mandate all Federal agencies to declassify most documents on research involving human subjects
• E. Congress should reestablish a National Commission for the Protection of Human Subjects
• F. VA and DOD should implement regular site visits to review Institutional Review Boards
• 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
Appendix -- Survey of 150 Persian Gulf War Veterans
IS MILITARY RESEARCH HAZARDOUS TO VETERANS’ HEALTH? LESSONS SPANNING HALF A CENTURY
I. INTRODUCTION
During the last 50 years, hundreds of thousands of military personnel have been involved in human experimentation and other intentional exposures conducted by the Department of Defense (DOD), often without a servicemember’s knowledge or consent. In some cases, soldiers who consented to serve as human subjects found themselves participating in experiments quite different from those described at the time they volunteered. For example, thousands of World War II veterans who originally volunteered to “test summer clothing” in exchange for extra leave time, found themselves in gas chambers testing the effects of mustard gas and lewisite. (Note 1) Additionally, soldiers were sometimes ordered by commanding officers to “volunteer” to participate in research or face dire consequences. For example, several Persian Gulf War veterans interviewed by Committee staff reported that they were ordered to take experimental vaccines during Operation Desert Shield or face prison. (Note 2)
The goals of many of the military experiments and exposures were very appropriate. For example, some experiments were intended to provide important information about how to protect U.S. troops from nuclear, biological, and chemical weapons or other dangerous substances during wartime. In the Persian Gulf War, U.S. troops were intentionally exposed to an investigational vaccine that was intended to protect them against biological warfare, and they were given pyridostigmine bromide pills in an experimental protocol intended to protect them against chemical warfare.
However, some of the studies that have been conducted had more questionable motives. For example, the Department of Defense (DOD) conducted numerous “man-break” tests, exposing soldiers to chemical weapons in order to determine the exposure level that would cause a casualty, i.e., “break a man.” (Note 3) Similarly, hundreds of soldiers were subjected to hallucinogens in experimental programs conducted by the DOD in participation with, or sponsored by, the CIA. (Note 4), (Note 5) These servicemembers often unwittingly participated as human subjects in tests for drugs intended for mind-control or behavior modification, often without their knowledge or consent. Although the ultimate goal of those experiments was to provide information that would help U.S. military and intelligence efforts, most Americans would agree that the use of soldiers as unwitting guinea pigs in experiments that were designed to harm them, at least temporarily, is not ethical.
Whether the goals of these experiments and exposures were worthy or not, these experiences put hundred of thousands of U.S. servicemembers at risk, and may have caused lasting harm to many individuals.
Every year, thousands of experiments utilizing human subjects are still being conducted by, or on behalf of, the DOD. Many of these ongoing experiments have very appropriate goals, such as obtaining information for preventing, diagnosing, and treating various diseases and disabilities acqui
red during military service. Although military personnel are the logical choice as human subjects for such research, it is questionable whether the military hierarchy allows for individuals in subordinate positions of power to refuse to participate in military experiments. It is also questionable whether those who participated as human subjects in military research were given adequate information to fully understand the potential benefits and risks of the experiments. Moreover, the evidence suggests that they have not been adequately monitored for adverse health effects after the experimental protocols end.
Veterans who become ill or disabled due to military service are eligible to receive priority access to medical care at VA medical facilities and to receive monthly compensation checks. In order to qualify, they must demonstrate that their illness or disability was associated with their military service. Veterans who did not know that they were exposed to dangerous substances while they were in the military, therefore, would not apply for or receive the medical care or compensation that they are entitled to. Moreover, even if they know about the exposure, it would be difficult or impossible to prove if the military has not kept adequate records. It is therefore crucial that the VA learn as much as possible about the potential exposures, and that the DOD assume responsibility for providing such information to veterans and to the VA.
II. BACKGROUND
A. CODES, DECLARATIONS, AND LAWS GOVERNING HUMAN EXPERIMENTATION
The Nuremberg Code is a 10-point declaration governing human experimentation, developed by the Allies after World War II in response to inhumane experiments conducted by Nazi scientists and physicians. The Code states that voluntary and informed consent is absolutely essential from all human subjects who participate in research, whether during war or peace. The Code states:
The person involved should have the legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health and person which may possibly come from his participation in the experiments. (Note 6)
There is no provision in the Nuremberg Code that allows a country to waive informed consent for military personnel or veterans who serve as human subjects in experiments during wartime or in experiments that are conducted because of threat of war. However, the DOD has recently argued that wartime experimental requirements differ from peacetime requirements for informed consent. According to the Pentagon, “In all peacetime applications, we believe strongly in informed consent and its ethical foundations . . . . . But military combat is different.” (Note 7) The DOD argued that informed consent should be waived for investigational drugs that could possibly save a soldier’s life, avoid endangerment of the other personnel in his unit, and accomplish the combat mission.
More than a decade after the development of the Nuremberg Code, the World Medical Association prepared recommendations as a guide to doctors using human subjects in biomedical research. As a result, in 1964 the Eighteenth World Medical Assembly met in Helsinki, Finland, and adopted recommendations to be used as an ethical code by all medical doctors conducting biomedical research with human subjects. This code, referred to as the Declaration of Helsinki, was revised in 1975, 1983, and 1989. (Note 8) It differs from the Nuremberg Code in certain important respects. The Declaration of Helsinki distinguishes between clinical (therapeutic) and nonclinical (nontherapeutic) biomedical research, and addresses “proxy consent” for human subjects who are legally incompetent, such as children or adults with severe physical or mental disabilities. (Note 9) Proxy consent for legally competent military personnel who participate in military research is not considered appropriate under the Nuremberg Code or the Declaration of Helsinki.
On June 18, 1991, the Federal Government announced that 16 U.S. governmental agencies would abide by a set of regulations, referred to as the “Common Rule,” designed to protect human subjects who participate in federally funded research. (Note 10) The provisions of the “Common Rule,” first promulgated for the Department of Health and Human Services (DHHS) in 1974, described how federally funded research involving human subjects shall be conducted. However, local Institutional Review Boards (IRB’s) may revise or exclude some or all consent elements if the research exposes subjects to no more than “minimal risk,” meaning “that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” (Note 11) IRB’s vary greatly in their interpretation of the risks of daily life.
There are three provisions governing research funded by DHHS that are intended to protect vulnerable populations, such as pregnant women and fetuses, prisoners, and children. (Note 12) There are no special Federal regulations to protect military personnel when they participate as human subjects in federally funded research, despite logical questions about whether military personnel can truly “volunteer” in response to a request from a superior officer.
Current law prevents the Department of Defense from using Federal funds for research involving the use of human experimental subjects, unless the subject gives informed consent in advance. This law applies regardless of whether the research is intended to benefit the subject. (Note 13)
21 & 22.
WAR’S REAL COST
Gulf War Illness and Our Veterans
Bringing things up-to-date, here are parts of two documents from 2010. The first comes straight from the Department of Veterans Affairs, and it has some pretty shocking statistics on how many veterans of the first Gulf War have suffered adverse health consequences. The second is testimony from Paul Sullivan, Executive Director of Veterans for Common Sense, given before the House Committee on Veterans’ Affairs on September 30. I found his statement heart-wrenching. What’s it going to take for our leaders to consider the real cost of these endless wars?
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MILITARY TAKEOVER
Operation Garden Plot: Our Military and “Civil Disturbances”
The curious thing is, a Civil Disturbance Plan called Garden Plot was in place more than ten years before 9/11. See if you agree whether this is a blueprint for the military taking over during any protest or “unrest” that might seem to be getting out of hand. In case you still think the Patriot Act couldn’t be applied to us.
Turning the military loose in our country to take care of things: Isn’t this what the National Guard is for, and doesn’t that fall under the jurisdiction of the states and their governors? It seems that the feds shouldn’t be coming in unless they’re asked. Which maybe they’d have to be now, because the National Guard is off fighting in foreign countries. It’s all ass-backwards. We’ve got the Guard in Iraq and they’re trying to turn the regular military loose on our own citizens. Again we owe that role reversal to George W. Bush.
I can understand occasions when federal help is needed, but this shouldn’t be top-down but bottom-up. You need to do this under great scrutiny, in very limited types of situations, to ensure that there are no abuses of power.
24 & 25
FREEDOMS FOR SAFETY?
“Emergency” Detention Camps and Civilian Inmate Labor Program
Are we ready for martial law? I think we are, because everybody’s sitting back and watching our freedoms being taken away and the handcuffs put on and “Newspeak” (read Orwell’s 1984 again, folks) being slowly put into practice. We can all proudly stand up as Americans and say
, Guess what? The terrorists are winning because our country has changed in the last decade, and not for the good. We’re a country that’s now living in fear and so are willing to trade our freedoms for safety—which I stand against and will go to my grave stating: “I’d rather face the terrorists on a daily basis than lose any of my freedoms.”
So let’s look at how the government has been intent on keeping us safe. First, a press release issued by KBR, a subsidiary of Halliburton (the company Cheney ran), early in 2006. It’s a joint deal they made with Homeland Security and Immigration & Customs Enforcement (ICE), “in the event of an emergency influx of immigrants into the U.S., or to support the rapid development of new programs,” whatever that means. Did you know that the ICE already had detention centers in place since it was established in March 2003?
Second, the Army went on to establish a Civilian Inmate Labor Program back in 2005. “This regulation provides Army policy and guidance for establishing civilian inmate labor programs and civilian prison camps on Army installations.” The italics are mine. Would somebody tell me what this means, so I don’t have to worry so much about what it implies?
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CONTINGENCY PLANNING
The Army’s Continuity of Operations Plan
Hours after the events of September 11, 2001, the Bush administration put “Continuity of Government” plans into operation for the first time in American history. These had actually been drawn up by Donald Rumsfeld earlier in the year, and when WikiLeaks published it, the document was affixed with a warning: “Destruction Notice: Destroy by any method that will prevent disclosure of contents or reconstruction of the document.”