The mustard gas experiments involved approximately 60,000
American soldiers in “race-based human experimentation” that sought to determine whether race or skin complexion influences one’s susceptibility to injuries from mustard gas. Researchers created “man-break” tests whereby service members were locked in gas chambers that were inundated with mustard gas until the point that the men became incapacitated. During the experiments, some soldiers were exposed to gas levels that were equivalent to those reported on World War I battlefields.
The “man-break” tests caused severe injuries to the service members. Soldiers experienced “immediate and severe eye injuries” and “enormous, grotesque blisters and oozing sores” on their “face, hands, underarms, buttocks, and genitals.” Exposure to mustard gas also caused blindness, intense vomiting, internal and external bleeding, and damage to the lungs and respiratory system. Many soldiers suffered long-term health effects
that included cancer, asthma, and psychological disorders.
For decades, the U.S. government refused to acknowledge the
existence of the studies or provide injured service members with
compensation or long-term health care. It was not until 1991—nearly five decades after the first studies began—that the government officially admitted to the use of soldiers in experimental research. The government also admitted that it did not fully disclose safety risks or obtain informed consent from the research participants, and that the service members may have suffered adverse health effects as a result of their participation in the studies.
Contemporaneous with the mustard gas experiments, the U.S. military conducted radiation experiments on American soldiers and civilians. In addition to testing the destructive capabilities of nuclear weapons, military researchers examined the effects of nuclear warfare on humans, animals, and the environment. As early as 1942, the military understood that exposure to radiation was likely to be quite dangerous, since “the deleterious effects of radiation could not be seen or felt and the results of over-exposure might not become apparent for long periods after such exposure.”
After years of detonating atomic weapons in the South Pacific, the
military began open air testing of nuclear weapons on American soil in the 1950s. Thousands of soldiers were placed, without protective clothing, in the immediate vicinity of atomic detonations. The military did not inform the soldiers of potential health risks or seek to obtain informed consent prior to participation in the trials.
While the military publicly denied any potential harm to humans,
plants, or animals, internal documents indicate that government officials had determined that there existed a causal relationship between radiation exposure and serious adverse health effects. Despite the health and environmental hazards, the Commissioner of the U.S. Atomic Energy Commission privately asserted that “[w]e must not let anything interfere with this series of tests—nothing.” It was later revealed that radiation exposure at the test sites was comparable to that of Hiroshima and Nagasaki.
Coupled with the open-air nuclear tests, the military funded studies at a number of well-respected American universities, including the University of Chicago and the University of California, whereby researchers injected unsuspecting civilians with radioactive elements that included plutonium, uranium, and polonium. This work continued through the 1970s, with
researchers targeting the elderly, patients in mental institutions, prisoners, and others “who did not have full faculties for informed consent.”
A congressional investigation later found that “[n]o evidence was elicited that informed consent was granted in any of the cases,” and that “[t]he government covered up the nature of the experiments and deceived the families of deceased victims . . . .”
In the 1990s, the government acknowledged that hundreds of
thousands of American service members had been involved in at least 1400 radiation projects over a thirty-year period during and after World War II.
These figures do not include exposure suffered by American civilians in connection with hundreds of “intentional radiation releases,” where researchers deliberately emitted radioactive substances into densely populated cities and other locations to test human response and environmental contamination. Although the government was aware that the radiation releases were likely to contaminate food and water supplies, many of the releases “took place with no public awareness or understanding.” Within ten years after the commencement of the detonations in America, childhood leukemia deaths and diagnoses, as well as adult cancer deaths and diagnoses, were exponentially higher in several detonation regions.
Investigational and Off-Label Use of Medical Products
Since at least the 1990s, the U.S. military has required service
members to subject themselves to both investigational and off-label use of medical products. Both off-label and investigational use involve utilization of a medical product for an indication that has not earned FDA approval. While each is properly characterized as experimental research because the FDA has not found that the underlying product is safe and effective for the stated use, there is an important distinction between the two categories. For products that are used off-label, the FDA has
determined that the product is safe and effective for at least one
Investigational medical products, on the other hand, have not
been approved for any indication. Non consensual use of off-label or investigational medical products raises a number of serious concerns. While physicians may prescribe drugs for off-label indications or investigational purposes, the decision to do so must be based on an evaluation of a patient’s particular health condition and risk factors, and should only occur where medical data
reflect meaningful evidence that the potential benefits are likely to
outweigh the known or expected risks and the patient provides informed consent to the treatment.
In a number of instances, the military has made off-label and investigational use of medical products compulsory for service members as a whole, and has not sought to obtain informed consent or provide adequate risk disclosures to individual soldiers. The discussion below explores four recent examples—pyridostigmine bromide (“PB”), the botulinum toxoid (“BT”) vaccine, the anthrax vaccine, and selective serotonin reuptake inhibitors (“SSRIs”).
After petitioning the FDA to establish a new rule that waives informed consent requirements for investigational use of medical products in times of existing or anticipated combat activities, the DoD sought and obtained permission from the FDA to use PB and the BT vaccine pursuant to the new regulation. Fearing use of chemical weapons during the Gulf War, the military decided to administer PB and the BT vaccine to all soldiers.
At the time, the FDA was evaluating the safety and efficacy of both
products as pretreatments for chemical warfare. In its informed consent waiver request to the FDA, the DoD argued that it would not be feasible to obtain informed consent because a soldier’s
“personal preference” does not supersede the military’s view that the drug and vaccine would contribute to the “safety of other personnel in a soldier’s unit and the accomplishment of the combat mission.” The DoD also argued that “obtaining informed consent in the heat of imminent or ongoing combat would not be practicable.”
The FDA granted the DoD’s requests, but the decision was not without controversy. The DoD claims that it trusted that the FDA had granted permission to use the investigational drug without informed consent because the FDA believed that the drug was deemed to be safe. The FDA, on the other hand, claims that it granted the waiver because it believed that the DoD determined that military necessity required an informed consent waiver.
Regardless of the reason why the FDA granted the waiver, as a
condition of the FDA’s permission to use the investigational medical
products without informed consent, the DoD agreed to: (1) provide
information on PB to all service members; (2) collect, review, and make reports of adverse events related to PB; (3) label PB as an investigational product that was solely for “military use and evaluation;” (4) ensure that each dose of the BT vaccine was recorded in each service member’s medical record; and (5) maintain adequate records related to the receipt, shipment, and disposition of the BT vaccine. The DoD failed to comply with each of these requirements.
Following use of PB and the BT vaccine during the Gulf War, veterans began suffering from serious health problems that include cognitive difficulties, chronic headaches, widespread pain, skin rashes, respiratory and gastrointestinal problems, and other chronic abnormalities. Gulf War veterans have been diagnosed with amyotrophic lateral sclerosis (“ALS”) at a much higher rate than that of the general population or veteran populations from other wars.49 Children of Gulf War veterans are also
born with birth defects at an alarming rate. Commonly referred to as Gulf War illness, these health problems affect over 175,000 Gulf War veterans, which amounts to more than twenty-five percent of the fighting force during the war. PB is included in the list of factors that are most likely to be a contributing factor to Gulf War illness.
by:AMERICA IS ISRAEL’S BITCH