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Using Human Subjects for Medical Research


Laboratory Science

FaIl 1997

Cristie Sanford


In May of 1993 my brother, Scott Siefken, began to suffer from strange rashes breaking out on various parts of his body. At first, they would come and go, only to reappear again in greater intensity. Equally mysterious were the large, painful sores developing in his mouth. At first, the rashes were casually explained away by things such as a different laundry soap, or an allergic reaction to some other common household product. Eventually, the persistence and progression of the rashes and mouth sores, led Scott to seek medical treatment. In the following year, the rashes only worsened, As test after test failed to determine that anything at all was wrong with my brother. Finally, in late August of 1994, Scott phoned my mother from the VA hospital in Des Moines, in very high spirits. He was at long last given a diagnosis: Lupus. My mother's heart sank, as she was unable to relate to him the grim meaning behind the name of his disease. He of course, thought he was on the road to recovery, as he felt that surely the proper treatment could now be prescribed. By this time the rash had turned into dollar sized blisters that would break open at the slightest touch or contact with anything, leaving open, mattering, and very painful sores which were now covering most of his body. As one of my younger sisters described it, it was as if his blood were boiling to the surface of his skin.

Once a diagnosis was made, what ever was wrong with Scott seemed to completely consume him. Within days he was rushed to the University of Iowa Hospital for emergency surgery to have the entire epidermal layer of his skin removed. The doctors felt that it was the only thing that might save his life. Even so, he was given only a five percent chance of surviving. He did not beat the odds. Scott died on October fifth, 1994, seven weeks after his surgery. The autopsy report listed the cause(s) of death as cancer of the lymph nodes, kidney failure, and blood poisoning. Lupus was ruled out. Scott's doctor at the University of Iowa Hospital Burn Unit told the family that he had never seen anything like this before, and that he had no idea what he was dealing with.

During Scott's hospitalization, my mother rarely left his side. Within the past few years she too has suffered with mysterious rashes, severe nausea, joint pain, muscle spasms, chronic fatigue, and frequent headaches, and just as recently as last week, she has been diagnosed with Lupus and Fibromyalgia, two diseases frequently diagnosed among Gulf War veterans suffering from the controversial "Gulf War Illness." Scott was a Gulf War Veteran.

Despite early efforts to squash any notion that chemical and biological agents were used against allied forces in the Persian Gulf War, documentation providing strong evidence is now surfacing that would prove to the contrary. Not only were they used, but documentation reveals that chemical companies and biological laboratories in the United States, funded by the United States Department of Defense manufactured them, and It was our own government who sold them to Sadam Husein. (Ref. B, p.1) Also in question are the inoculations the troops were given just prior to their deployment to the Gulf region. While only a few troops were given a choice, the majority were ordered to receive the inoculations. What were these inoculations for? Were they approved by the FDA?

Cries of conspiracy, cover-up, and even more bazaar, the idea that the entire Gulf War was a staged "experiment" in chemical and biological warfare, are among much of the conversation I've heard in recent years. These are things that anyone who loves this country would find difficult to believe. But the truth is that while we as a people can point a self-righteous finger at governments like China that trample on the idea of fundamental human rights, our own government has a dark, dirty secret as well.

In the two decades following the close of World War II there was an extraordinary expansion of human experimentation in medical research. Long after peace returned many researchers continued to use wartime rules, but focusing their efforts on the cold war and the war against disease. The utilitarian justifications that had flourished under conditions of combat persisted, in disregard of principles of consent and voluntary participation. (Ref. A, p.2252)
   
The driving force in research in the United States after World War II was the National Institute of Health (NIH). Formed in 1930 as an offshoot of the research laboratory of the US Public Health Service, the NIH assumed its prominence as the successor agency to the Committee on Medical Research. In 1946, its appropriations totaled $700,000. By 1955, the figure had climbed to $36 million, and by 1970, $1.5 billion, a sum that allowed It to award 11,000 grants, about one-third requiring experiments on humans. In expending these funds, the NIH administered an intramural research program at its own Clinical Center, along with an extramural program that funded outside researchers. (Ibid.)

The Clinical Center assured its subjects that it put their safety and well-being first. "The welfare of the patient takes precedence over every other consideration" ( NIH, 1953). In 1954 a Clinical Research Committee was established to develop principles and to deal with problems that might arise in research involving normal, healthy volunteers. But, the relationship between researcher and subject was casual to a fault, leaving it up to the researcher to decide what information, if any, was to be shared with the subject. Generally the researchers did not indulge their subjects with very much information, fearful that they would discourage their patients from participating. No formal policies or procedures applied to researchers working in other institutions on studies supported by NIH funds. (Ibid.)

The laxity of procedural protections pointed to the enormous intellectual and emotional investment in research and to the conviction that the laboratory would yield answers to the mysteries of disease. This faith was so great that the NIH would not establish guidelines to govern the extramural research it supported. By 1985 the extramural program was the single most Important source of research grants for universities and medical schools, by the NIH's own estimate, supporting between 1500 and 2000 research projects involving human research. Nevertheless, grant provisions included no stipulations about the ethical conduct of human experimentation and the universities did not fill the gap. (Ibid.)

One might have expected much greater attention to the ethics of human experimentation in the wake of the trial of the German doctors at Nuremberg. Nazi experimental atrocities included investigation of quicker and more effective means of sexual sterilization (including clandestine dosing and unanesthetized male and female castration) and death (an area of study Leo Alexander (1949) termed "thanatology," which included studies of techniques for undetectable individual assassination - i.e., murder that mimics natural death - as well as mass murder). Among the best known cases were the hypothermia experiments, which investigated mechanisms of death by freezing and means of preventing it. These studies, motivated by the loss of German pilots over the North Sea, included immersing prisoners In freezing water and observing freezing's lethal physiological pathways. Nazi experimentation also included deprivation of oxygen to learn the limits of bodily endurance, or deliberate infection by lethal organisms in order to study the effects of drugs and vaccines. The knowledge of these things should have sparked a commitment in the United States to a more rigorous regulation of research. So too, the American research efforts during the war might have raised questions of their own and stimulated closer oversight. Unfortunately, that has not been the case. (Ref. A1 p.2253)

The Nuremberg Code of 1948 Itself might have served as a model for American guidelines on research with human subjects. Its provisions certainly were relevant to the medical research conducted in the United States. "The voluntary consent of the human subject is absolutely essential," the code declared. "This means that the person involved should have legal capacity to give consent. By this principle the mentally disabled and children were not suitable subjects for research - a principle that American researchers did not respect. Moreover, according to the Nuremberg code, the research subject "should be so situated as to be able to exercise free power of choice", which rendered at least questionable the American practice of using prisoners as research subjects. The Nuremberg Code also stated that human subjects "should have sufficient knowledge and comprehension of the elements of the subject matter involved as to make an understanding and enlightened decision", thus ruling out the practice of using the mentally disabled as subjects. (Ibid.)

However, with few exceptions, neither the code nor these specific practices received sustained analysis before the early 1970's. Only a handful of articles in medical or popular journals addressed the relevance of Nuremberg for the ethics of human experimentation in the United States. Perhaps this silence reflected an eagerness to suppress the memory of the holocaust. More likely the events described at Nuremberg were not perceived by most Americans as relevant to their own practices. From their perspective, the code had nothing to do with science and everything to do with Nazis. The guilty parties were seen less as doctors than as Hitlers henchmen. (Ibid.)

How researchers exercised discretion was the subject of a groundbreaking article by Henry Beecher, professor of anesthesia at Harvard Medical School, published in June 1966 in the New England Journal of Medicine. His analysis, "Ethics in Medical Research," contained brief descriptions of twenty two examples of investigators who risked "the health or the life of their subjects," without informing them of the dangers or obtaining their permission. In one case, researchers purposefully withheld penicillin from servicemen with streptococcal infections in order to study alternative means for preventing complications. The men were totally unaware that they were part of an experiment, let alone at risk for contracting rheumatic fever, which twenty five of them did. Beecher's conclusion was that unethical or questionably ethical procedures "are not uncommon" among researchers. Although he did not provide footnotes for the examples or name the researchers, he did note that "the troubling practices" came from "leading medical schools, university hospitals, private hospitals, governmental military departments, government institutes (the National Institutes of Health), Veterans Administration Hospitals, and industry" (Beecher 1966). (Ibid.)

Two of the cases that Beecher cited were especially important in provoking public indignation over the conduct of human research. One case involved researchers who fed live hepatitis virus to the residents of Willowbrook, a New York State institution for the retarded, in order to study the etiology of the disease and attempt to create a protective vaccine against it. The other case Involved physicians injecting live cancer cells into twenty two elderly and senile hospitalized patients at the Brooklyn Jewish Chronic Disease hospital without telling them that the cells were cancerous, in order to study the body's immunological responses. (Ibid.)

Another case that caused fierce public reaction in the early 1970's was the Tuskegee research of the US Public Health Service. Its researchers had been visiting Macon County, Alabama since the 1930's to examine, but not treat a group of African Americans who were suffering from secondary syphilis. The objective was to study the natural progression of untreated syphilis. Four hundred subject-victims were studied, along with two hundred uninfected control subjects. The study, whose first published scientific paper appeared In 1938, continued until a news paper account of it appeared in 1972. Its subject-victims were either uninformed or misinformed about the purpose of the study, as well as its associated interventions. Whatever rationalizations the PHS had for not treating these individuals in the 1930's when treatment was of questionable efficacy and very complicated to administer, it could hardly defend instructing draft boards not to enlist the subjects for fear that they might receive treatment while in the army. Worse yet, it could not justify its unwillingness to give treatment, even long after the discovery of penicillin. (Ref. A, ps. 2254, 58)

During the 1950's and 1960's not only individual researchers but government agencies as well conducted research that often ignored the question of consent of the subjects, putting many of them at serious risk. Many of these studies involved the testing of radiation on humans. Part of the motivation was to better understand human physiology; even more important, however was the goal of bolstering the national defense by learning about the possible impact of radiation on our fighting forces. Accordingly, inmates at the Oregon State Prison were subjects in experiments to examine the effects on sperm production by exposing their testicles to X rays. Although the prisoners were told some of the risks, they were not informed that the radiation might cause cancer. So, too, terminally ill patients at the Cincinnati General Hospital underwent whole body radiation, in research supported. by the US Department of Defense, not so much to measure its effects against cancer, but to learn about the dangers radiation posed to military personnel. During this period, the Central Intelligence Agency also conducted research on unknowing subjects with mind altering hallucinogens and psychiatric techniques in an effort to improve interrogation and brainwashing methods. It was not until the 1980's that parts of this record became public, and not until 1994 that the full dimensions of these research projects were known. (Ref. A, p.2254) No treatment or follow up was ever offered to these subjects, and some were so affected, they ended up committing suicide. (Ref C, p.24)

Much unethical research comes to light only after many years after it is conducted, as is true of unethical military research conducted by the United States during and immediately following World War II. At that time, over 60,000 US servicemen were involuntarily enrolled in studies involving exposure to chemical warfare agents (mustard gas and lewisite); at least 4000 of them were exposed to high concentrations in field experiments and test chambers. (Ref A, p.2258)

Information about experiments on human radiation response supported by the US government beginning in 1945 came to public attention in 1993. In one study, conducted from 1945 to 1947, eighteen patients considered to be terminally ill were injected with high doses of plutonium to determine how long it was retained in the human body. Military secrecy surrounding atomic energy precluded informed consent. Rather than telling subject-victims they would receive an injection of radioactive plutonium, the researchers told subjects they would receive a "product." Experiments on intellectually handicapped teenagers in a Massachusetts institution involved feeding the subjects very small amounts of radioactive iron and calcium to study the body's absorption of these materials. While the radiation exposure in these studies was low and unlikely to cause harm, the subject-victims were all incompetent, and their parents who consented on their behalf, were simply asked by the institution to agree to "nutritional experiments." In reaction to news accounts of these and other studies, orders were issued in 1993 to declassify documents relating to unethical exposure of US service personnel and citizens to radiation from atomic weapons testing after World War II; in 1994 President Bill Clinton appointed a panel to guide federal investigation into the radiation studies. (Ref. A, p.2258, 59)

Several themes emerge from the known examples of unethical research. Such studies are likely to be done involving disenfranchised or disadvantaged populations as test subjects. In the absence of public outcry, unethical research may continue for many years despite the fact that readers of the scientific literature in many cases have had access to all the facts they need to expose unethical practice. The larger and more egregious studies are especially likely to have been motivated by national security concerns and funded by the military. (Ref. A, p.2259)

House Bill 15090 documents an Appropriation Hearing in 1970 by the Departrnent of Defense to procure ten million dollars for the research and development of a synthetic biological agent. The document states that they believed that within a period of five to ten years it would be possible to produce a "synthetic biological agent that does not naturally exist, and for which no natural immunity could have been acquired." Basically it is saying that this synthetic biological agent will attack and destroy the immune system. In 1975 was the first AIDS related death. (Ref. E, ps. 3,4) What are the chances that the above mentioned synthetic biological agent and the HIV virus are one and the same? Would the population of a remote area of Africa and or the homosexual population be considered to be expendable subject-victims, therefore making them among the first to be unknowingly used to further the research?

Approximately 50,000 to 100,000 US soldiers returned from Operation Desert Storm with unusual illnesses characterized by a variety of chronic signs and symptoms. Ph.D. Microbiology Scientists, Garth and Nancy Nicolson, working out of The Institute for Molecular Medicine in Irvine California had earlier experience with a disease that caused similar complex signs and symptoms. They proposed that the Persian Gulf War Illness might be caused by a severe mycoplasmal infection and that it should be treatable with appropriate antibiotics. A pilot study was conducted of Desert Storm Veterans and their families for the presence of unusual mycoplasmal infections. This study showed that 55/73 GWI patients, including symptomatic family members, responded to an antibiotic (doxycycline) that is effective against a variety of mycoplasmas, and these soldiers and their family members who were sick with the same symptoms eventually recovered from their illness. (Ref. D, p.1)

The mycoplasmas found in a sizable fraction of the Gulf War Illness patients are unlikely to be naturally occurring and could be biological weapons. This notion was based on the observation that the mycoplasmas found in clinical blood samples from Desert Storm veterans contain unusual DNA sequences that they probably did not obtain in the wild. For example, there were detected mycoplasma DNA sequences from Mycoplasma fermentans (incognitus strain) and modified Mycoplasma genitallium as well as the HIV-1 envelope gene in veterans and their family members with GWI. Mycoplasmas possessing the HIV-1 envelope gene could allegedly have been engineered to make them more invasive and pathogenic and more difficult to find. The HIV-1 envelope gene encodes a surface glycoprotein that is involved in virus attachment and entry into cells through receptors on the cell surface. This could result in opportunistic cell attachment and penetration of many types of cells and most tissues. (Ibid.)

One could be suffering severely from this type of mycoplasmal infection, and less sensitive tests, such as antibody tests could be negative. Since the mycoplasma that has been detected is present deep inside the cell, the usual antibody tests for extracellular mycoplasmas may be relatively useless. The most sensitive type of DNA test, the polymerase chain reaction (PCR) technique, could also prove negative in an infected individual, because DNA chains of the invading mycoplasma may be tightly complexed with nucleoproteins and might not be accessible for the PCR reaction. Gulf War Illness appears to be a collection of illnesses produced as a result of multiple chemical and biological exposures from endogenous and exogenous sources such as Chemical/BiologIcal Weapons. (Ref. D, p.2)

The effects of these exposures were exacerbated by the harmful and synergistic side effects of unproven (untested) pyridostigmine bromide (PB) pills (nerve agent pre-treatment pills) forcibly administered to our troops, botulinum toxiod vaccines (also untested and experimental) forcibly administered to our troops, anthrax vaccines, and several other experimental vaccines, all forcibly administered to our troops like so many laboratory guinea pigs. (Ref. C, p.3)

Virtually all of the US and allied troops were forced (on threat of court martial, or Article 15, if they refused) to take a series of experimental vaccines and pills which had not been approved by the FDA and which made many of our troops instantly and violently ill. (Ref. C, p. 18)

Of all responding personnel who had taken the anti-botulism medicine, 88 percent were told not to turn it down and 35 percent suffered side effects. None of the women given botulism toxoid were told of pregnancy risks. (Ibid.)

The 1/8/91 issue of the New York Times which carried an article entitled: "Our Guinea Pigs in the Gulf" wrote: "The Defense Department, on obtaining permission to give experimental drugs to American troops in the Persian Gulf, is about to violate the Nuremberg Codes, one of tne primary moral documents to emerge from World War II. "At Its request, the Pentagon has been given a special Food and Drug Administration waiver it sought, to require the troops to take experimental drugs and vaccines during combat, or if there is a threat of combat. "Since Nuremberg no government has officially attempted to justify research on competent adults without their informed consent-that is not until our government said exceptions would be permitted so that specific unapproved drugs and vaccines could be administered to the troops without their consent.

"The Pentagons rationale for radically altering the standard procedure in military life was that It was "not feasible" to get informed consent from combat troops." (Ref. C, p. 19)

Estimates of the numbers of vets who are sick are just that-estimates. Over 160,000 sick Gulf War veterans have reported to the Gulf War registry (kept by the Department of Defense-which still maintains that the disease does not exist). This does not include wives, children or other family members, friends or associates (secondary infectees) who are sick, disabled, dying or dead. (Ref. C, p.3)

The Nicolsons have concentrated on the chronic illness associated with Desert Storm, especially those involving immediate family members who also have become ill. The fact that these Gulf War Illness patients with their family members who have become sick with similar chronic signs and symptoms indicates that these diseases are similar and are contagious. (Ref D, p.3)

They also studied personnel working in the Texas Department of Criminal Justice (TDCJ) who have an array of signs and symptoms that are, as assessed by environmental physicians, identical to Gulf War Illness. These individuals were tested (like Desert Storm veterans) using Nucleoprotein Gene Tracking. Preliminary results parallel observations in Desert Storm veterans and suggest that these illnesses were present in the United States before the Gulf War. The Nicolsons strongly suspect that TDCJ prisoners were illegally used in Biological Weapons testing. Thus the modified mycoplasmas detected in Gulf War veterans may have their origin in the US. "It is interesting," say the Nicolsons, "that before Desert Storm some Texas biotechnology companies were developing vaccines (apparently under US Army contracts) and testing them in TDCJ prisons," (Ibid.)

If detected early, the diseases associated with invasive mycoplasmal infections are treatable with multiple cycles of antibiotics, but the confusing panorama of signs and symptoms, and current political policies are making it difficult for Gulf War veterans and their families to get medical treatment. (Ibid.) It is estimated that up to 15,000 Gulf War veterans have died since they've returned to the United 5tates. Up to 200,000 are ill, and at least 70 percent have given it to at least one family member. Even more alarming is the 67% birth defect rate among children born of Gulf War veterans. (Ref. C, p. 3)

Life (11/95) featured a special report entitled: "The Tiny Victims of Desert Storm" which described in heartrending detail (with numerous photos) how the children of our veterans are being born with horrendous disfiguring birth defects. The article was subtitled: "When our soldiers risked their lives in the Gulf, they never imagined that their children might suffer the consequences-or that their country would turn its back on them. (Ref. C, p.6)

In the months and years following Desert Storm, thousands of babies have been born to vets with horrible deformities (missing limbs, one eye, missing ears, incomplete or missing organs-reminiscent of the Thalidomide babies of the 1950's - but in far greater numbers. (Thalidomide was another experimental drug, administered to pregnant mothers, that went awry). (Ibid.)

Meanwhile, the Department of Defense is working overtime to cover up the crisis with Gulf War babies, denying it exists, denying benefits or medical assistance to veterans with birth defected children, and even going so far as to censor the Life article cited above off the internet. (Ibid.)

Is it then possible that our own government would stand by with full knowledge that our brothers and sisters, sons and daughters, husbands and wives, fathers and mothers, and friends were indeed exposed to harmful chemical and biological agents, only to do nothing? It is a matter of record that our troops were forced to take experimental drugs and vaccines without their knowledge or consent. It is a matter of record that such blatant disregard of Human Rights (the right to be fully Informed, and the right to say "no" ) has been going on in this country for years. And it is a matter of record that even though treatment for the majority of Gulf War illnesses exists, they are being told there is nothing physically wrong with them, and therefore, they are being denied treatment. To continue to deny treatment, when treatment exists, to tens of thousands of Persian Gulf War veterans and their family members who are also becoming ill is unconscionable. Or is Operation Desert Storm an ongoing human experiment that will take years to study the pathology of a genetically engineered, highly infectious biological agent? How many more need to die in the name of science and national security?

Note:    Reports from the Middle East, especially those Gulf countries in or near the war zone indicate that up to 25 percent of the civilian populations are infected with Gulf War Illness. Dr. Garth Nicolson says, "Approximately 20-25 percent of the inhabitants of the Persian Gulf area are afflicted with the disease. According to an Iraqi emissary, 250,000 have died of the GWI, and another million are sick." Persian Gulf countries would include Iraq, Iran, Saudi Arabia, Kuwait, Baharain, Oman, and the UAE. No figures are available for Syria.(Ref. C, p 21)
   
Bibliography


Ref. A: "Human Research in the war against Disease," Encyclopedia of Bioethics, volume IV, 1995, PS. 2252-54,58,59.

Ref. B: http://www.calpte.com/PGW/tuite/chembio.html U.S Chemical and BioIogical Exports to Iraq and Their Possible Impact on the Health Consequences of the Persian Gulf war. Committee Staff Report No.3:
"Chemical warfare Agent Identification, Chemical Inquiries, and other Findings." U.S. Senate Committee on Banking, Housing, and Urban Affairs.
James J. Tuite, III, Principal Investigator. p.1

Ref. C: "Special Report: Germ Warfare Against America - The desert Storm
Plague and Cover-up." The McAlvany Intelligence Advisor. August 1996, PS.
3,6,8,18,19,21.

Ref. D: "Summary of Persian Gulf War Illness Pilot Study on Mycoplasmal
Infections in Veterans and Family Members." Garth L Nicolson, Ph.D. and
Nancy L. Nicolson, Ph.D. Ps. 1,2,3.

Ref. E: "Gulf War Syndrome, Biological Warfare Conducted on U.S. Military
Members, and Corporate Bio-Genocide Levied on the Planetary Population."
A lecture by Captain Joyce Riley, USAF, in Houston, Texas on Jan 15, 1996.
Transcript by Leading Edge Research Group. p.3.
   
Acknowledgements: Special thanks to Dr.'s Garth and Nancy Nicolson for giving freely their time and expertise to the Gulf War Veterans and their family members who are desperate to know what's wrong with them.

And thank you Captain Joyce Riley for your untiring efforts to inform veterans and the public at large all you have uncovered in your exhaustive research in the past four years. (also freely given) I stand before you and salute you. And to your wonderful husband Dave Ridell may you ever continue to be the wind in her sails.

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