The current regulations do not permit a determination that obtaining informed consent is otherwise not feasible or is contrary to the best interest of the subject . . .

II. DOD’s Request

. . . FDA assistance is also needed on the issue of informed consent. Under the Federal Food, Drug and Cosmetic Act, the general rule is that, regardless of the character of the medical evidence, any use of an IND, whether primarily for investigational purposes or primarily for treatment purposes, must be preceded by obtaining informed consent from the patient. The statute authorizes exceptions, however . . .

Our planning for Desert Shield contingencies has convinced us that another circumstance should be recognized in the FDA regulation in which it would be consistent with the statute and ethically appropriate for medical professionals to “deem it not feasible” to obtain informed consent of the patient – that circumstance being the existence of military combat exigencies, coupled with a determination that the use of the product is in the best interest of the individual . . .

In all peacetime applications, we believe strongly in informed consent and its ethical foundations. In peacetime applications, we readily agree to tell military personnel, as provided in FDA’s regulations, that research is involved, that there may be risks or discomforts, that participation is voluntary and that refusal to participate will involve no penalty.[i]

In the late 1980s, the Department of Defense had a problem. It was anticipating the need for better means to combat chemical and biological agents and, to the point, the U.S. was way behind the Soviet Union in its chemical and biological warfare preparedness. Protective suits and gas masks are the primary means of biological and chemical defense. Different garments are worn depending on the threat level. This is referred to as MOPP level and the garments are referred to in military slang as MOPP gear (Military Operational Protective Posture). Revelations circa 2000 made it clear that even the protective suits and gas marks issued to troops were defective in large numbers.[ii] The DoD made assertions initially that the defects were not serious and not widespread. A subsequent inspection revealed failures of entire lots and the DoD eventually sued the manufacturer.[iii]

Besides protective suits and gas masks, the DoD’s assertion was that the only way to defend against many chemical and biological agents is through the use of drugs and vaccines. Drugs are typically administered after a person has been exposed to a particular agent in order to counteract the agent’s effects, to the extent those drugs can. Vaccines, in the case of biological agents, theoretically may provide some prospective protection if the particular vaccine produces the proper response to the agent or disease to which the soldier is exposed. The process obviously involves a lot of guesswork, from the perspective that in the first instance, we never know definitively what agent the enemy will use and, secondarily, no one knows for certain what any individual’s immune response will be to the vaccine especially vis à vis the introduction of some weaponized disease, gas, or other agent. These uncertainties were never more apparent than in the Gulf War.

To return to the example at the end of the last chapter regarding the hypothetical drug PB that combats the hypothetical illness MG. Pyridostigmine Bromide (PB) had been licensed since 1955 as a treatment for terminally ill patients with a disease called myasthenia gravis (MG), a degenerative neurological disorder. Prior to the Gulf War, after receiving an informed consent waiver from the FDA, the DoD issued troops PB in pill form as a pretreatment for a certain nerve agent, soman (SM in my example) that the USG believed Iraq might use against U.S. troops. Eventually we learned that Iraq had no such agent, but instead had a different agent called sarin – yes, that gas. The PB that the U.S. had issued to its troops would almost certainly have aggravated the effects of sarin on U.S troops, not ameliorated it, due to the underlying chemical mechanisms in the brain.[iv]

Vaccines are no better because of the specificity with which the body develops an immune response. For example, there is no vaccine against the common cold because, like most viruses, it mutates constantly, thus defying the immune system’s “memory”, or its capability to reproduce antigens to fight diseases that it already recognizes. The anthrax bacteria has dozens of strains (some have numbered it at 33) that are produced as a biological weapon. The current anthrax vaccine is based upon one of the weaker strains of anthrax that is passed as a result of skin contact with the pelt of an animal having the bacteria spores in it. This is to say nothing of genetic manipulation of strains, which would make them completely resistant to any antigen produced by the body. Thus, any vaccine, no matter which one, necessarily relies upon the hope that the agent to be used by the enemy will be the exact one for which the body has an immune response. There are also additional considerations, including the risks of adverse reactions that any vaccine or drug carries with it, a very real possibility when vaccinating a population the size of the entire U.S. Armed Forces – several million people. In 1989, the Assistant Secretary of Defense Robert Barker sent a letter to Senator John Glenn in answer to questions from a Senate Governmental Affairs Committee regarding the escalation of the biowarfare threat. In the letter Barker expressed the limitations on vaccines as a pretreatment for chemical and biological weapons.  Interestingly, he specifically noted the limitation of the anthrax vaccine as a pretreatment for chemical warfare, a position evidently reversed by the DoD a short time later during its lobbying effort with the FDA.

Current vaccines, particularly the anthrax vaccine, do not readily lend themselves to use in mass troop immunization for a variety of reasons: the requirement in many cases for multiple immunizations to accomplish protective immunity, a higher than desirable rate of reactogenicity, and, in some cases, lack of strong enough efficacy against infection by the aerosol route of exposure.”[v]

Notwithstanding all of these limitations, as the Gulf War approached the DoD began a concerted effort to get the FDA to allow the DoD to use investigational, and even experimental, drugs either as pretreatments for chemical-biological agents or in response to such an exposure. The DoD was seeking a waiver from Rule 50.23(d)’s strict requirements of obtaining informed consent from servicemembers prior to treating them with a number of agents. The DoD was turned down on a number of these requests because the drugs were so experimental. Then-Commissioner of the FDA, Ronald Kessler, explained before a house committee in 1996 that

I had just become Commissioner. Desert War broke out immediately thereafter. There were INDs available for certain drugs to treat both anthrax and botulism toxin. In fact, one of them was not just – there was no interest in a manufacturer producing them but had been used for many years.

The Army came and said we have soldiers going into battle.  Only years later did we learn that Saddam really did have stockpiled some of these biological agents. And in the midst of that crisis, I made the decision that we needed to make sure that we knew everything possible about these drugs.

In fact, one drug they wanted to use was a skin cream to prevent nerve gas. We went up to the plant and inspected the plant, and we found that before it was released it caused blisters on the arms.[vi]

Even the licensed drug PB was considered investigational because the DoD was going to use a different dosage than the licensed indication and was going to use it as a pretreatment for a nerve agent, rather than as a treatment against the disease myasthenia gravis. The FDA expressed reluctance to give the DoD a complete, blanket waiver from Rule 23(d)’s requirements, so a compromise was reached. A Senate Committee looking into this in 1994 summarized the events well.

In August 1990, the DOD contacted FDA to review regulatory restrictions of DOD’s plan to use pyridostigmine and botulinum toxoid for U.S. troops in the Persian Gulf. The major focus of the meeting was informed consent. The DOD sought a waiver of requirements for informed consent for the use of pyridostigmine bromide and botulinum toxoid, arguing that these investigational products had well-established uses and were safe. They also claimed that there were no reasonable alternatives. According to minutes of the meeting, “FDA expressed some concern about liability and the need to comply with the regulations,” and FDA’s Deputy Director for Drug Review “pointed out the need to establish an appropriate investigational framework to collect observational data and evaluate the military medical products in question.”[vii]

One wonders if DoD officials had the same concerns about liability and lawsuits that the FDA did. As has already been shown, the tendency of courts, including even the United States Supreme Court, to shy away from questioning military decisions because of the inherent lack of expertise of judges in matters martial was certainly known to DoD officials and lawyers. In these discussions between the FDA and the DoD, despite the fact that the FDA is the federal agency given the statutory authority to regulate drugs and biologics, the DoD insisted that it could administer the drugs if it so chose to, in complete defiance of the Nuremberg Code or the Helsinki Declaration, or the regulatory authority of the FDA.

. . . DOD informed FDA that they did not want to abide by informed consent regulations, and FDA officials pointed out that pyridostigmine and botulinum toxoid were investigational and that there are laws regulating how they can be used. DOD claimed that “under the DOD directive the Secretary of Military Departments [could] dictate the use of unapproved FDA regulated products” in the Persian Gulf, but “DOD’s current position is that this not their primary choice at this time.”[viii]

Exactly what DoD directive Defense officials were relying upon is not clear.  How that DoD directive could trump the FDA’s regulatory authority over drugs and biologics is not clear, either. How an Armed Service Secretary could decide all alone that he/she would ignore forty-five years of law is not only unclear, it boggles the mind. International law in the form of the Nuremberg Code and the Helsinki Declaration, and by 1990, a United States statute that made the Nuremberg Code a part of federal law, 50 U.S.C. §1520a, all said this was a human rights violation. The U.S. put people to death for violating this principle, yet here is concrete evidence – if what happened to MSgt Stanley and Nathan Schnurman were not proof enough – that the DoD felt it was free to disregard any law in pursuit of the military mission, in this case, the War with Iraq. We can leave aside the issue of whether or not the war served any useful or legitimate purpose; we should not forget, however, that there was never any Congressional declaration of war.

There is a Latin maxim that inter arma leges silentae sunt: “amid the clash of arms the laws are silent.” This might be acceptable for a nation engaged in a civil war or threatened with invasion and can perhaps (I am being generous) explain the actions of military governors post-Civil War or (maybe?) the internment of Japanese during World War II. But in no way could the Gulf War possibly justify the DoD’s defiance of plain U.S. and international law for an ‘optional,’ undeclared war halfway around the world: but there it was and is. If the DoD’s actions do not speak clearly enough, a memo by Deputy Secretary of Defense John Deutsch to a Senate Committee after the war sums the DoD’s position up succinctly: “Although pyridostigmine and botulinum toxoid were classified as investigational drugs as required by FDA regulations, they were not used for experimental purposes in [Operation Desert Storm] and the military personnel who received these products were not experimental subjects.”[ix] Mr. Deutch felt that “these drugs were used for treatment purposes, not research purposes,” and additionally had been, “specifically approved by the courts in litigation challenging the governments [sic] actions.” The DoD’s position was that because they didn’t really intend for the use of these drugs to be research, it therefore wasn’t research. Moreover, because they won in court in a suit filed by a soldier in federal district court[x], the DoD now had “specific approval” from – of all branches – the courts! The Senate committee’s comment on this letter in its report cuts to the heart of the problem with that logic: “Once again, it appears that the DOD confuses the goals of using these medical products with the process, which was clearly considered investigational by FDA.”[xi]

My position is neither anti-war, nor anti-national security, rather it is pro-law, and pro-ethical principles. Either the United States is a nation of laws protected by an Armed Force committed to the same, or it is not. We cannot be dedicated (selectively) to ‘principles’ – and only when convenient. Situational ethics is an oxymoron; ethical principles are not situational. This commitment to principle is not mere naïveté, but an important aegis that serves to protect both our troops, our citizens, and even our enemies. If we are not committed to these principles, particularly when they are a pain for us to follow or when we can invoke mantras like ‘national survival’, then things like MKULTRA, the Atomic Energy tests, Nathan Schnurman’s mustard gas experiences, the internment of Japanese citizens, and other more unspeakable tragedies are inflicted upon the innocent. It is too easy to dismiss these incidents as anomalous or products of their time, rather than facing the legal, moral, and ethical reality that these repeated incidents are a product of a cultural mindset that values results – mission completion – over all else, including the rights of citizens and soldiers.

After some lengthy debate surrounding the issue of rule 23(d) waivers between the FDA and DoD, an agreement was finally reached on December 13, 1990, about how these products would be administered to U.S. troops. According to the minutes of that meeting, “DOD officials agreed that the botulism vaccine would be administered by trained individuals with a health care background, and that information would be provided orally ‘at minimum, and in written form if feasible, to all personnel receiving the vaccine.’”[xii] The essence of the agreement was that the DoD assured the FDA that although informed consent would not be sought from each individual, the DoD would ensure “that at least verbal [sic] information would be provided to each person receiving the vaccine.”[xiii]

There were some additional issues that were raised at these meetings regarding vaccines and drugs being given to pregnant women. With the introduction of women into military roles closer and closer to front-line combat has come the necessary consideration of gender differences and pregnancy among troops. The FDA’s Informed Consent Waiver Review Group recommended that

pregnant women be excluded from receiving the vaccine and that information about the vaccine be “posted at places where vaccine is administered.”  However, DOD argued that pregnant women would be at greater risk from exposure to botulism toxins than to the vaccine, and FDA agreed that instead of excluding pregnant women, a statement would be added to the information sheet stating that, “If you are pregnant, it is not known if this vaccine will hurt the unborn baby, however, most vaccines do not.”[xiv]

Unfortunately, notwithstanding these assurances by the DoD, inquiries by Congress and the DoD itself after the War showed that the overwhelming majority of servicemembers were told little or nothing about the drugs and vaccines they received.[xv]  As the Committee on Veterans Affairs noted in 1994:

DOD had promised to provide extensive information about potential risks orally and in writing. In addition to being ordered to take an investigational product without informed consent, most Persian Gulf War military personnel surveyed claim they received no oral or written information about the drug or vaccine, despite the DOD promises to FDA to provide information about potential risks. These claims are supported by a survey conducted by the Department of Defense following the Persian Gulf War.[xvi]

This lack of promised information was not an isolated incident where a few people were not told. The post-war surveys conducted by both Congress and the DoD showed that the medical personnel administering the shots in most cases had no idea what they were administering, what the side-effects were, or any possible adverse effects.[xvii] Eight (8) or Nine (9) out of every ten servicemembers surveyed were told nothing or that they simply had to take the given drug. In one DoD survey, 16 of 23 corpsmen administering the PB tablets provided no information to servicemembers. The history of this particular drug, referred to “hypothetically” earlier in this chapter, bears some close examination as its procurement and use by the DoD bears a striking resemblance to the anthrax vaccine.

A brief chemistry lesson is necessary to understand just how bad the Department of Defense got this. Nerve agents come in two types, carbamates and organophosphates (OP). The best known OP agents, developed by the Germans in the 1930s and ’40s and still in use today, are tabun, sarin, soman, and VX gas. These agents all operate basically the same way: the agents bind to an enzyme, acetylcholinesterase (AChE). This enzyme is responsible for “turning off” the neurotransmitter acetylcholine (ACh), which sends nerve impulses to the muscles. When these agents bind to the enzyme, AChE, they prevent the enzyme from turning off the muscle impulses. If ACh continues to produce uncontrolled muscle stimulation, it results in twitching, loss of muscle coordination, weakness, and ultimately, can produce death. In graphic language, it turns a man into a twitching, frothing, writhing mass of flesh until he dies.

Pyridostigmine Bromide (PB) is a drug licensed by the FDA and used to treat myasthenia gravis patients. It was first licensed in 1955.[xviii] Myasthenia Gravis is a degenerative neurological disease that is characterized by extreme weakness. It is caused by the production of antibodies that interfere with the uptake of the enzyme, acetylcholine (ACh) at the neuromuscular junction. Pyridostigmine is actually a nerve agent itself, but it is a carbamate. PB acts similarly to OP agents in that it inhibits production of AChE also, but it limits it the production to about 40% and its effect is reversible. Thus, in high quantities, PB produces an increase in the production of AChE that overcomes the blockage of antibodies at the neuromuscular junction.

The theory behind using PB as a pretreatment for the nerve agent soman is that it would limit the level of AChE production to 40%, thus negating the (threatened) OP agents’ complete inhibition of AChE. Further, PB is used in conjunction with two other agents found in the standard Nuclear, Biological, Chemical (NBC) treatment kits, 2-PAM-chloride and atropine. 2-PAM-choride reverses PB’s inhibition of AChE and the atropine theoretically counteracts any overstimulation due to the accumulated acetycholine (ACh) at the neuromuscular junction.

Of course, it bears repeating that PB has never, ever been tested in such a fashion. The theories on the chemistry above are just that, theories based upon the current understanding of PB upon myasthenia gravis patients and the known properties of OP nerve agents. Complicating matters even more was the dosing problem: the DoD gave soldiers two 30 mg tablets to take every eight hours, likely as a concession to safety. The dosage for myasthenia gravis patients can reach as high as 120 mg every three hours. Thus, not only was the use of PB for a different purpose, it was used in a different dosing, both in schedule and amount, than its licensed or prescribed use, making it an experiment by any reasonable definition of the word.

Finally, and unfortunately, because of the intricate chemistry in our brains, it is believed that PB would actually be less effective against sarin and might make one more susceptible to its effects. At the close of the Gulf War, we would learn that Iraq stocked sarin, not soman. While the DoD denied for 6 years that there were any exposures of U.S. troops to nerve agents, it finally admitted in 1997 that some 100,000 servicemembers may have been exposed to the nerve agent sarin when the U.S. destroyed an ammunition supply dump at Kamisiyaw at the close of the War. The DoD covered this information up for years, causing some to call for the DoD to lose its authority to investigate the possible causes of Gulf War Illness.[xix]

This does not end the story, though. Quite possibly more damning than any of the legal requirements the DoD is the scientific evidence that DoD had collected in its own studies of the effects of PB before applying for the waiver of informed consent. It makes their claims of safety to the FDA ring deathly hollow.

The DoD conducted a number of different studies on pyridostigmine bromide in the late 1980’s. Almost none of those studies included women, which is problematic for two reasons. First, there is some data to suggest that women have differing levels of AChE than men. Women on birth control for certain have differing levels of AChE than men, as do women in different stages of their reproductive cycles. Second, dosing is based upon weight, so there should be some consideration for the differing physiologies of men and women (i.e. the average man weighs significantly more than the average woman.)

In these 1980s studies, the DoD had concerns about the safety of PB, so the studies screened out persons who might be hypersensitive to PB, or to bromide more generally, or people who might be taking certain medications, such as propranolol, birth control medications, or anti-malaria medications. Smokers were ruled out of certain studies and participants in some were told not to drink alcohol. People with blood pressure abnormalities, asthma, glaucoma, hyperthyroidism, GI disorders, or, probably most directly of concern, people with low serum AChE levels were kept out of some of the studies.[xx]

Notwithstanding all of these concerns and safety measures taken by DoD in its own PB experiments, some test subjects still had severe reactions to PB. For example, during one study, PB was given to “a group of 28 active duty Air Force pilots. One pilot experienced respiratory arrest 91 minutes after swallowing the third in a series of three 30-mg pyridostigmine tablets. This pilot had shown no sensitivity to the test dose of pyridostigmine prior to the study.”[xxi] In another study of 32 males, one person “lost consciousness following vision problems and headache.”[xxii] In still other studies, “abnormal liver tests, unusual electrocardiograms, gastrointestinal disturbances, and anemia were reported.”[xxiii] Most interesting from a scientific perspective, and perhaps from an ethical perspective as well, was that some of these same studies “showed that pyridostigmine impaired performance, including tasks which require short-term memory, and prevented a number of test subjects from exercising in hot environments during the second or third day of treatment.”[xxiv] With hundreds of thousands of soldiers in the desert of Saudi Arabia, where temperatures routinely reach the hundred degree level, the DoD had in its possession clinical data that suggested that some people were affected differently by PB under hot conditions. No one had ever considered that all of the data previously obtained from myasthenia gravis patients was in the relatively aseptic, sterile environment of a hospital. This area of scientific inquiry would produce additional troubling data after the Gulf War, which I explain with in the Epilogue.

In August 1990, as U.S. troops were preparing to go to the Gulf, the DoD’s scientists requested approval for a four-man study that would “evaluate the effects of pyridostigmine on vision.”[xxv] This study was quickly approved because of the urgency of events in Kuwait and Saudi Arabia. This study included extensive safety precautions.  Each man was given a medical exam before receiving the PB. There were restrictions on the subjects – they could not have “bronchial asthma, peptic ulcer, liver, kidney, heart disease, or hypersensitivity to pyridostigmine or related drugs.”[xxvi] Volunteers were informed that possible adverse side effects included “nausea, vomiting, slow heart rate, sweating, diarrhea, abdominal cramps, increased salivation, increased bronchial secretions, and pupil constriction.” The scientists also warned the subjects of other possible adverse effects, including “weakness, muscle cramps, and muscle twitches.”  Because of these possible side effects, “all subjects will be admitted to Lyster Army Hospital as in-patients so that they will be medically monitored during evening periods of non-testing. A drug will be available at the test site to counteract the possible adverse side effects.”[xxvii] Finally, the Human Subjects Committee reviewing this study gave some thought to adding a clause to the consent form explaining that there was a “possibility of pyridostigmine causing death . . .after some discussion, it was decided that such a warning was unnecessary since death was unlikely.”[xxviii]

These extensive precautions were being taken at the exact same time, in August of 1990, that the DoD was simultaneously urging the FDA to waive the requirements of Rule 23(d) and informed consent for the exact same drug – and the FDA granted the request in December of 1990. This was despite the data from the previous studies and the data being collected in the August 1990 study. Months later, DoD would beging giving PB to some 400,000 U.S. soldiers, including approximately 28,000 women, and others who were not screened for any diseases, sensitivity to PB, or any other possible at-risk factor for PB.

In 1993, Dr. James Moss at the U.S. Department of Agriculture (USDA), conducted studies on cockroaches using pyridostigmine bromide in conjunction with several different pesticides. Nerve agents are very similar chemically to modern pesticides. These common insect repellants, such as DEET (diethyl-m-tolamide), a very popular repellant available in almost any Post Exchange, and permethrine, a chemical that was treated in the uniforms of Gulf War soldiers, had increased levels of toxicity when used in conjunction with PB. DEET is more toxic by a factor of seven and permethrine twice over when used in conjunction with PB. Likewise, PB was found to be four times more toxic when used in conjunction with DEET. These studies also showed increased toxicity for other substances, such as lindane, a treatment for lice used during the Gulf.[xxix]

George Santayana once trenchantly observed that “those who cannot remember the past are condemned to repeat it.” The history of pyridostigmine bromine’s use during the Gulf War is instructive because of what it portends for servicemembers in the new era of biological warfare. Will servicemembers’ bodies become the new battlefield, with each new biological threat giving rise to a new prophylactic countermeasure – a new drug, vaccine, or antibiotic? More importantly, will the safety data be timely enough to protect servicemembers’ health? As of 2003, there were an estimated 100,000 veterans of the Persian Gulf War suffering from some symptoms that defy classification, but are undeniably, objectively real, notwithstanding DoD’s claims (which have gradually changed over time and investigation) that the diseases are nothing more than PTSD – post traumatic stress disorder. Studies have shown several potential causes, including the anthrax vaccine, nerve agents in the Gulf, and PB and/or its interaction with the heat and other chemicals. If the lessons of the Gulf were not learned, they might again be repeated, resulting ultimately (if one chooses to be a hardline pragmatist) in cost to the taxpayers for skyrocketing veterans’ disability claims.

PB’s history has some important parallels to the current anthrax vaccine program and for future Biological Warfare (BW) programs. DoD claimed that PB was a “licensed product” by the FDA many years ago, supporting claims of long-term safety anecdotally, although there were certainly no epidemiological studies regarding its administration to healthy individuals. It was claimed that scientists had enough knowledge about how PB worked and the chemistry involving nerve agents to infer a particular result for the effectiveness of PB against a particular agent. PB’s use was clearly investigational, as the DoD acknowledged by asking for Rule 23(d) waivers and by its submission of a New Drug Application and a clinical protocol for PB. Over the course of time, however, the DoD’s position varied from (a) we can do this if we want to ultimately… but it is our choice to follow the procedures at this point, to (b) this was not “research” but “treatment” because of how we intended to use these things, so no informed consent is necessary, to (c) we won in court when someone tried to get an injunction, so therefore this is legal. This position changed each time Congressional inquiry yielded more and more information (to paraphrase the Nixon impeachment hearings) about “what the DoD knew and when they knew it.” Leadership in Congress, frustrated by the DoD’s intransigence and dissembling, swamped by calls from constituents and veterans with GWS/GWI, and bemused by investigative journalism that revealed continued DoD cover-ups, would finally decide to act in 1997. So would the DoD.

Endnotes

[i] Informed Consent for Human Drugs and Biologics; Determination That Informed Consent Is Not Feasible, 55 Fed. Reg. at 52814

[ii] See http://www.defenselink.mil/news/Mar2000/n03142000_20003142.html.

[iii] Id.

[iv] Cite to aggravating effects of PB on sarin in GAO report.

[v] Letter from former Assistant Secretary of Defense Robert B. Barker to former U.S. Sen. John Glenn, chairman of the Senate Governmental Affairs Committee, 24 Aug 1989, transcript of Senate Hearing 101-744.  The letter and quotes from Barker to Glenn are on page 474 and 480 (emphasis added).

[vi] Testimony on March 12, 1996, before the House Committee on Appropriations’ Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.

[vii] Staff Report Prepared for the Committee on Veterans’ Affairs, Senate Report 103-97 (1994)(citing a Memorandum for Record, August 30, 1990, submitted by Craig R. Lehmann, Lt. Col., USAF, BSC; in Committee files.)

[viii] Staff Report Prepared for the Committee on Veterans’ Affairs, Senate Report 103-97 (1994)(citing an FDA memorandum from Richard Klein and Ann Graham to Stuart Nightingale, September 7, 1990; in Committee files.)

[ix] 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.

[x] The case, Doe v. Sullivan, 756 F. Supp. 12 (D.D.C. 1991) is interesting because the judge, Stanley Harris, made it clear that he was no expert in military matters and therefore the “DOD’s decision to use unapproved drugs is precisely the type of military decision that courts have repeatedly refused to second-guess.”  Doe at 13.  The judge also believed that the “primary purpose of administering the drugs is military, not scientific.”  Doe at 15-16.  The Nuremberg Code is not mentioned anywhere in his opinion, nor the federal statute codifying it.

[xi] Staff Report Prepared for the Committee on Veterans’ Affairs, Senate Report 103-97 (1994).

[xii] Id.  (Draft of minutes, meeting between officials of DOD and FDA, December 31, 1990, provided by FDA to Committee; in Committee files.)

[xiii] Id.

[xiv] Id.

[xv] Staff Report Prepared for the Committee on Veterans’ Affairs, Senate Report 103-97 (1994).

[xvi] Id.

[xvii] Id.

[xviii] 44 Fed. Reg. ________.

[xix] Amy Waldman, Credibility Gulf: The Military’s Battle over Whether to Protect its Image or Protect its Troops, Wash. Monthly, Dec. 1996, at 28, 28-29.

[xx] S. Rep. No. 103-97 (1994), n. 114.

[xxi] IND Amendment, 28 March 1988, IND 28,480.

[xxii] IND Annual Report, 1987-1988, IND 23,509.

[xxiii] See Senate Report No. 103-97 (1994), notes. 117, 118, 119.

[xxiv] Id.

[xxv] 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.

[xxvi] Id.

[xxvii] Id.

[xxviii] S. Rep. No. 103-97 (1994).

[xxix] Id.