On May 6, 1994, the Senate Committee on Veterans held a hearing titled: “Is Military Research Hazardous to Veterans’ Health? Lessons from World War II, the Persian Gulf and Today.” Rudolph R. Mills had been in a gas chamber experiment when he was 18 years old. He testified:
“I had on an experimental mask and the Navy was trying to determine if people wearing these masks could communicate with each other. I was enticed to sing over the intercom….No one ever told me that the mask became less effective against the gas with each use….We were sworn to secrecy….At the age of 43 I underwent a long series of radiation treatments and later surgery to remove part of my voice box and larynx….It didn’t occur to me that my exposure to mustard gas was responsible for my physical problems until June 1991, when I read an article in my hometown newspaper.”
John T. Harrison participated in Navy chemical tests in 1943 to get an extra week pass. He was also sworn to secrecy. In his written testimony submitted to the committee, he stated:
“[I] was never warned or told anything about the dangers of what [I] volunteered for….told never to reveal what [I] did or where [I] was; if anyone asked [I] was to say [I] was on rowing maneuvers.”
At the time of his discharge from the military, he could not even describe his exposures to a Navy doctor who was trying to determine the cause of his severe respiratory illnesses. Although Mr. Harrison has suffered from recurrent breathing problems and has greatly diminished pulmonary function, he has never received any compensation for his illness. According to the VA and DOD, his medical and services records have been lost, making it difficult to prove that his disability is service-connected.
A 1994 staff report by the Senate Committee on Veterans Affairs (Excerpted) FINDINGS AND CONCLUSIONS
FOR AT LEAST 50 YEARS, DOD HAS KNOWINGLY EXPOSED MILITARY PERSONNEL TO POTENTIALLY DANGEROUS SUBSTANCES, OFTEN IN SECRET.
The U.S. General Accounting Office issued a report on September 28, 1994, which stated that between 1940 and 1974, DOD and other national security agencies studied hundreds of thousands of human subjects in tests and experiments involving hazardous substances. (Note 65) GAO stated that some tests and experiments were conducted in secret. Medical research involving the testing of nerve agents, nerve agent antidotes, psychochemicals, and irritants was often classified. Additionally, some work conducted for DOD by contractors still remains classified today. For example, the Central Intelligence Agency (CIA) has not released the names of 15 of the approximately 80 organizations that conducted experiments under the MKULTRA program, which gave psychochemical drugs to an undetermined number of people without their knowledge or consent. According to the GAO report, the CIA has not released this information because the organizations do not want to be identified. (Note 66)As recently as 1993, the Institute of Medicine of the National Academy of Sciences reported that an atmosphere of secrecy still existed regarding World War II testing of mustard gas and lewisite. (Note 67) Although many documents pertaining to the World War II testing programs were declassified shortly after World War II ended, others remain “restricted” even today. In addition to the classified or restricted documents, World War II veterans who participated in the research were sworn to secrecy. These classified documents and promises of secrecy have impeded medical care for thousands of veterans during half of the last century.
For example, Rudolph R. Mills participated in gas chamber experiments as an 18-year-old in 1945, one year after he joined the U.S. Navy. (Note 68) He was sworn to secrecy and did not learn until 46 years later that approximately 4,000 servicemen were human subjects in mustard gas experiments conducted from 1942 through 1945 by the Chemical Warfare Service. Although his health began to deteriorate even before his discharge from the Navy in 1946, he did not learn that mustard gas might be responsible for his physical problems until more than 40 years later.
COLD WAR VETERANS
During the years immediately following World War II, military personnel were intentionally exposed to radiation during the testing of atomic bombs and during radioactive releases. While it is unclear how many of these servicemembers were intentionally exposed to what were known to be harmful levels of radiation, there is clear evidence that in some cases military personnel were ordered to locate themselves in areas of high radioactive fallout. They were given no choice in the matter, and they were not told of the potential risks of those exposures.
Similarly, military personnel were intentionally given hallucinogenic drugs to determine the effects of those drugs on humans. The servicemembers were not told that they would be given experimental drugs, they had no choice of whether or not to take them, and even after the unusual effects of the drugs were obvious to researchers, the unwitting human subjects were given no information about the known effects of the drugs. Even if the DOD did not know about the potential long-term effects of the drugs, that would not justify their failure to provide information to thousands of servicemembers about the known short-term effects of the drugs.
PERSIAN GULF WAR VETERANS
Persian Gulf veterans were also given investigational vaccines and ordered not to tell anyone. In a Committee survey of 150 individuals who served in the military during the Persian Gulf War (see Appendix), many of those surveyed indicated they were ordered, under threat of Article 15 or court martial, to discuss their vaccinations with no one, not even with medical professionals needing the information to treat adverse reactions from the vaccine. Similarly, 86 percent of the military personnel who told the Committee that they were ordered to take pyridostigmine bromide reported that they received no information on what they were taking or the drug’s potential risks. According to a DOD study published in the Journal of the American Medical Association, commanding officers and medical personnel were also inadequately informed about the investigational drugs; as a result, they were ill-prepared to recognize or treat military personnel who experienced side effects. (Note 71)
DOD HAS REPEATEDLY FAILED TO COMPLY WITH REQUIRED ETHICAL STANDARDS WHEN USING HUMAN SUBJECTS IN MILITARY RESEARCH DURING WAR OR THREAT OF WAR.
The major principle of all research ethics involving human subjects, as described by the Nuremberg Code, the Declaration of Helsinki, and the “Common Rule” of the U.S. Government, states that the voluntary, competent, informed, and understanding consent of the subject is absolutely essential, whether during war or peace. (Note 72)These standards are more than 50 years old. For example, the Nuremberg Code was based on testimony of two U.S. physicians, Drs. Leo Alexander and Andrew Ivy, who served as expert medical witnesses for the Nazi crime prosecutors. The code was not the outcome of an attempt to frame a new code of ethics, but rather a description of criteria said to be widely accepted by the medical profession at the time. (Note 73) Therefore, DOD research during the 1940’s was clearly conducted in an era when researchers were well aware of ethical codes regarding the use of human subjects.
The Department of Defense has violated these well-established ethical principles each time soldiers are required to participate in military research or take investigational drugs or vaccines or are not adequately informed about the risks of the experiments.
Participation in military research is rarely included in military medical records, making it impossible to support a veteran’s claim for service-connected disabilities. . . Army regulations exempt informed consent for volunteers in some types of military research. . . . Additionally, some of these human subjects were threatened with imprisonment at Fort Leavenworth if they discussed these experiments with anyone, including their wives, parents, and family doctors. For decades, the Pentagon denied that the research had taken place, resulting in decades of suffering for many veterans who became ill after the secret testing.
1. Military personnel were not given the opportunity to refuse investigational drugs. 2. Military personnel were not informed about the risks of the investigational drugs.
There are two kinds of risks associated with lack of information. One is a lack of trust. In the survey conducted by Committee staff, 14 of 73 (19 percent) Persian Gulf War veterans who had been ordered to take pyridostigmine bromide indicated that they did not take all the pyridostigmine bromide they were ordered to take, fearful that the drug was responsible for the symptoms they experienced (Appendix).
Because no one would answer their questions about the safety and efficacy of the pyridostigmine bromide, they feared they were receiving a potentially harmful drug. Therefore, if pyridostigmine bromide had been crucial for surviving nerve agent exposure, an unknown number of individuals would have lacked protection because they had received inadequate information about the drug.
The other risk is that even if serious side effects were rare, they could have been treated if medical personnel were able to diagnose the problem. For example, Carol Picou, a nurse who was stationed in the Gulf for 5 months, had obvious side effects from the pyridostigmine starting on the third day that she took it.
These side effects included incontinence, drooling, and blurry vision, among others. The side effects became worse 1 hour after she took each pill. One day, she did not take the pill as scheduled, and the side effects stopped; unfortunately, her commanding officer ordered her to continue taking the pills, and watched to make sure she swallowed them. She was ordered to take the pills for 15 days. She now has many permanent medical problems, including incontinence, muscle weakness, and memory loss, that might have been avoided had she been allowed to stop taking the pills. (Note 87)
DOD INCORRECTLY CLAIMS THAT SINCE THEIR GOAL WAS TREATMENT, THE USE OF INVESTIGATIONAL DRUGS IN THE PERSIAN GULF WAR WAS NOT RESEARCH.
Despite the fact that pyridostigmine was an investigational drug whose safety and effectiveness had not been proven to FDA, the DOD claims that its use in the Persian Gulf War was prevention and treatment, not research.
DOD USED INVESTIGATIONAL DRUGS IN THE PERSIAN GULF WAR IN WAYS THAT WERE NOT EFFECTIVE.
The DOD persuaded FDA that informed consent should be waived for pyridostigmine bromide and botulism vaccine because these investigational products had been used safely in the past. However, based on documents provided to the Committee staff, it is doubtful that either of these products would have been effective as used in the Persian Gulf War.