Glibertarians.com 2019 Archive

Category: DoD Anthrax Vaccine

  • Chapter 8: “It’s Against the Law!!”

    I didn’t even knock on Justin’s door, I busted in like Kreamer on a Seinfeld episode.  Justin had a client sitting in front of his desk.

    “Sir–” Justin began as a young lance corporal turned around to see who had just come in.

    “Oh, shit. Sorry. When you’re done, could you come by my office?”  I asked.

    “Yes, sir, we’re almost done.” Justin continued to call me “sir” for appearances, but we had already tried a case or two as co-counsel, he was due to pin on Captain soon, and we spent a lot of time off-duty, playing rugby and roller hockey, along with the fact that as a single guy there wasn’t a whole lot for him to do off-base in Okinawa. My kids loved him, while he and my wife had an ongoing North-South argument that made the Civil War appear just that. I went back to my office to wait.

    “What’s goin’ on?” he asked curiously, when he came by a few minutes later. He could see the smile on my face.

    “Dude, I got this in the mail.” I held up a stack of documents, about four hundred pages total, bound together.

    “Is that the stuff from Bates’s attorney, what was his name?” Justin asked.

    “Yes, Bruce Smith and a guy named Lou Michels, who’s a partner in McGuire, Battle, and Woods, by the way.” McGuire, Battle and Woods was a fairly well-known law firm outside of Washington, D.C. in Virginia, not far from where Justin went to high school. He raised his eyebrows.

    “Well, what’s in there?” he asked.

    “Listen to this carefully – there is a federal statute, ten u.s. code section one-one-zero-seven, that says the DoD cannot give a service member an investigational new drug or a drug unapproved for its applied use without the service member’s informed consent.”

    “Okay . . .”  Justin waited for the punch line.

    “Here, my good man,” I brandished a thick sheaf of papers, “I hold in my hand, the investigational new drug application from the company that makes the anthrax vaccine.” Justin’s eyes opened wide. “And,” I went on, “here is the cover page for the IND application, in which the DoD asks to join the application and even asks the FDA to hurry up and approve it so they can start testing!”

    “No way! Come on.” I handed him the application, which contained the entire clinical protocol.

    “And, better yet, the application specifically asks for a change to get the anthrax vaccine licensed for an aerosolized exposure.” Justin looked at me quizzically. “You know how all of those AFARTS radio commercials have been saying that the vaccine has been licensed for thirty years; that it’s been licensed against anthrax?”

    “Oh, you mean the ‘education program’ – the DoD brainwashing campaign? Yes, I’ve been taking copious notes since there’s only one English speaking radio station on the island and the Armed forces owns it.” Justin’s voiced dripped with sarcasm. I laughed. I was sick of hearing about the mandatory anthrax education video, too.

    “Well,” I ploughed on, “you can get anthrax three ways: you can get it through your skin, you can get it intestinally by eating some infected food, or you can inhale the spores – and that’s how it would be delivered in combat, in an aerosolized form –”

    “— from an artillery round,” Justin jumped in.

    “. . . or a sprayer from a crop duster, or bomb of some kind.” I finished. “The company that manufactures it and the DoD specifically asked the FDA for a modification of the existing license in order to get it approved for that use.”

    “What does that mean, though? Was it approved or just ignored?” Justin was still suspicious.

    “Neither, it was acted upon, and here’s the ace in the hole, the President of the company testified before Congress like six months ago that ‘we still continue to hold an IND for the anthrax vaccine.’ Dude, it’s an IND, hence you can’t give it without informed consent, hence the program currently violates federal law. Quod Erat Demonstratum, Homes.”

    Justin looked at me.

    “I follow everything except the Latin.”

    “Oh, sorry, dude. Q.E.D. It’s what you put at the bottom of a geometry proof when you solve it. It means like ‘what was to be shown, was’ or something like that.  You didn’t have to do that in high school?” Justin looked at me and shook his head.

    “Proofs, yes. Trivial Latin phrases, no. We had to learn to speak English first,” he deadpanned.

    “Backwards Virginia school systems.”

    “Yeah, right.” He sat down.

    “I can’t believe this,” he went on, thumbing through some papers. “I mean, how the hell did somebody not find this before? Don’t get me wrong, Dale. I think you’re a good attorney, and I know I’m great, but these aren’t the first anthrax refusal cases. How come it hasn’t come up before?” I had asked myself this same question and done some research.

    “I think a couple of reasons. First, the law only changed in late 1998 and some of the first cases were at 29 Palms. Second, would you have ever thought to look for a federal statute regarding investigational drugs in order to show the order wasn’t lawful?”

    “Hmmmm. Yeah, good point. But how come no one in the SecDef’s office picked up on this? He must have a host of lawyers working for him.”

    “Same answer, man. The anthrax program was launched in late 1997 and early 1998, but the law didn’t change until late 1998. So, in the Secretary of Defense’s defense, that law wasn’t out yet. However, the law actually reached back and so it doesn’t grandfather anything. In other words, if the SecDef wants to give troops an IND or a drug unapproved for its applied use, then he has to get a waiver from no one less than the President himself.” I sat back in my chair. I couldn’t have been prouder, although in truth I had done very little of the grunt work. My client, David Ponder, had actually hounded me to contact Mr. Bruce Smith, who had in turn put me in touch with Mr. Lou Michels, a LtCol in the Air Force Reserves and partner at McGuire, Battle and Woods, who sent me a very nice packet of information. By miraculous coincidence, David Ponder was from the same part of Kentucky as Major Sonnie Bates and had followed Major Bates’ case in the press pretty closely, as had his wife Jennifer. Eventually, David’s wife got in touch with Major Bates’ wife, Roxanne, who then connected David with some information and now here I was.

    “There’s one other possibility, ya know,” Justin murmured. I sat forward. He looked up. “They knew about the law and just fucking ignored it.” I hadn’t thought of that and refused to consider it; it sounded ominous the way he said it. He went back to reading.

    “This is unbelievable,” he said it out loud, but he was talking to himself as he read. I was thinking the same thing. The anthrax program, on its face, violated a federal statute.

    Normally, in an orders violation case, the government enjoys a strong presumption that an order is lawful. Usually, all the government has to do is ask the judge to find as a matter of law that an order was lawful and then, once the judge rules in the government’s favor, the prosecutor only has to show that the order was transmitted to the accused and the accused refused to obey it. The defense has a pretty high burden to overcome the presumption of lawfulness… but there I sat with the smoking gun.

    The DoD’s own signature on an IND application to amend the existing anthrax license in order to get an indication against aerosolized anthrax, the exact use to which the government was putting the vaccine. I sat there smiling, luxuriating in the feeling. I could tell Justin was, too.

    “You know what?” he began, smiling.

    “What?” I was smiling back, almost laughing.

    “I cannot wait to tell this to Jay tonight at the O club.” I bust out laughing. Jay Town was another of our classmates from Naval Justice School. He and Justin were close friends, had attended The Basic School together, a six month infantry school for all Marine officers, and lived near each other in the Bachelor’s Officers Quarters (BOQ).  Unfortunately, however, depending upon one’s view, Jay was assigned as the Deputy Staff Judge Advocate for 1st Marine Aircraft Wing. He was the assistant to the General’s lawyer. In our parlance as defense attorneys, he was a government “hack” and we taunted him endlessly about it. With a few beers in us all, the Officer’s Club on Kadena Air Force Base should supply some laughs that night. He was constantly needling us about our job defending “criminals.”

    “Do you think he’ll feel obligated as a government weenie to tell someone about this?” I asked, considering whether we should share it. Our anthrax cases had nothing to do with 1st MAW, so Jay was a spectator on this case. Jay was also a good friend, but then again….

    “No, he won’t care.” I nodded agreement. “But that won’t stop me from harassing him as the government representative,” Justin said, laughing.

                                                                                                                                                               

    “In short, sir, that means that if the defense can show that the anthrax vaccine is an investigational new drug, then the order violates the express terms of . . . 10 U.S.C. §1107. The statute creates rights, namely the right to informed consent before any service member accepts an investigational new drug.”

    June 27, 2000.

    It was almost three months after our first session of court in April. We had a discovery hearing on 9 June that accomplished nothing, just jousting. I could probably get my hands on anything I needed. Bruce Smith, Lou Michels, and some of their cohorts, were quick to answer any email and seemed to have an incredible list of contacts. If, for example, I had a question about FDA licensing procedures, ten minutes later an affidavit from a former high-ranking FDA official, now retired, appeared on my fax machine.

    “So,” I continued, “it’s the defense’s contention that under Supreme Court case law, under FDA regulations, and under any of the other applicable standards that have been set forth as to what is an investigational new drug, the defense will put on evidence to show that the anthrax vaccine is an investigational new drug.” Okinawa in late June was tropical, so it was hot in the courtroom. I looked over to see Petty Officer Ponder with a sheen of sweat on his forehead, but it might just as well be from nerves. I could feel my white tee-shirt sticking to me under my “Charlie”, service “C”, uniform. The air conditioner was on, which made a noise like a 707 engine being turned up. I had to speak loudly.

    “Therefore, if it is an investigational new drug and service members are being forced to take it against their will, that violates statutory rights that have been conferred by the Executive Order and the statute, 10 U.S.C. §1107.” I felt like I was starting to hit my stride. “And I would note, sir, that in the Manual for Courts-Martial . . . on page IV-20, at the top of the page, the first full paragraph – it says, ‘Relationship to Statutory or Constitutional Rights. The order must not conflict with the statutory or Constitutional rights of the person receiving the order.’” I had set it out as clearly as I could and the judge appeared genuinely interested, or he was doing a good job of faking it.

    I sat down and wrote some notes and we debated some discovery issues and eventually the government called the Group surgeon to put some evidence in the record about the threat of anthrax and the general nature of the anthrax program. During the doctor’s direct testimony, I made some notes, but I couldn’t have cared less about what he was going to say. While the judge was going to allow me to cross-examine the doctor, a Navy Commander, it would be for giggles mostly. He had very limited information on the program. Our case would rise and fall on 10 U.S.C. §1107, not on my cross-examination of a Navy doctor.

    Back in my office, I put my air conditioner on full and tried to pull the sticky tee-shirt away from my body. David Ponder and Justin were in the room. I turned to newly pinned Captain Constantine.

    “Well, how did it come off? Do you think the judge got it?” I was asking for reassurance more than critique. It was lonely in defense and it wasn’t often that someone came and watched a case to offer support.

    “I was actually looking for pointers on how to present the arguments for Arroyo’s case. I thought it went pretty well.” Justin represented PFC Vittolino Arroyo, one of three Marines who had all refused the shot together. Justin and I represented LCpl Jason Stonewall together.

    “Sir, I thought you did great.” David Ponder sounded genuinely impressed, with his southern drawl. He was as sincere a person as I had ever met. It was the first time a client had used such words; most clients I had acquitted were less effusive than David was being.

    “I just hope he gets it,” I mumbled to myself as much as anyone else. On some visceral level, it was crucial for me to convince the judge. I had crossed over the line at some point from mere advocacy to personal entreaty. I believed in 10 U.S.C. §1107 as fervently as my young daughters believed in Santa Claus, probably more so.

    I went to the window and opened it. There was a slight breeze stirring the hot, sticky, Okinawan air, a few scattered clouds in an otherwise blue sky. I heard a familiar slapping and thudding sound and looked to the right, over the trees toward Marine Corps Air Station Futenma, perhaps a mile straight line distance from where I was on Camp Foster. A Cobra helicopter was in a climbing left hand turn, the thirty-two inch thick blades beating the air as the pilot climbed to what must be the autorotation pattern altitude of one-thousand feet. Those blades were truly awesome in their power, the tips turning at just under the speed of sound, each blade weighing 385 pounds. I had once seen what they could do to another aircraft and the human body up close. In 1996, I had served on an aircraft mishap board for a mid-air collision between a Cobra and a CH-46 Sea Knight, or “Phrog”, as it was affectionately known. During that board I had learned that I was selected for the Funded Law Education Program. Sifting through the wreckage, and then having to return home at the end of the day, living a block from the wife and children of one of the dead pilots, had made my decision to either accept or turn down the program a lot easier.

    “Beautiful day for flyin’,” I said to no one in particular.

    “What’s that, sir?” Ponder asked. I turned around and brought my thoughts back to the present.

    “Nothing. Hey, don’t worry too much about the judge denying our discovery. We’re just playing footsy at this point. I can get my hands on everything through “alternative means,” but I was hoping to have the government produce the documents to eliminate any concerns about their authenticity. Even the judge denying our expert, Doctor Nass, isn’t a killer. Remember that biology professor I told you about?”

    “Yes, sir. Mr. Cohen, is that his name?”

    “Yeah. He said he will testify if we can’t get our expert here and he may not have the specific knowledge that Dr. Nass does, but he’s got a PhD in microbiology and he thinks the program is shitty. So, that gets him there in my book.” Justin laughed.

    “What are our chances, sir?” Nobody laughed at David’s question. I had thought about this a lot. I had four acquittals, three of them came in bench trials in front of the same judge now hearing the anthrax cases. Some of the prosecutors had needled me that Judge Stone was partial to me. In reality, the cases had not only been shitty for the government, but I believed, no – knew, they had come out the right way.

    “I don’t know, BT3. I mean, there is a federal law that says pretty clearly that you can’t be ordered to take the shot without your informed consent. All we have to show is that the vaccine is investigational and we’ve got the friggin’ application. That would seem to sufficiently rebut the presumption of lawfulness, but the judge was saying some weird things in chambers in Stonewall’s case. I just hope he gives us our chance to put this on in front of a jury. We sure have a lot of evidence.” I nodded toward the box in the corner of my office that was filled with Government Accounting Office reports, briefs, binders, transcripts of other cases, an Inspector General’s report on the contractual relationship between the DoD and the manufacturer, and a number of Congressional committee transcripts and reports. And that didn’t include the stuff I had at home and on my computer, not yet printed.

    “Looks like you’re earnin’ what I’m payin’ you, sir,” Ponder cracked. I laughed.  Justin moaned. He was always talking about ‘getting out’ and finally getting paid like a ‘real lawyer’ for the work he did.

    “Hopefully you’ll still be saying that if the judge loses his mind and things don’t go so well.” I was only half-joking.

  • Chapter 7 – Congress Acts: 10 U.S.C. §1107

    More can and must be done, however, to rebuild trust, to avoid repeating past mistakes, and to prevent future health consequences similar to those experienced during and after the Gulf War. Our troops must be assured that when we send them into battle, they will be protected by the best military technology, the best leaders, and the best medicine. Protection also means proper education and training, as well as provision of critical information, including information about investigational new drugs that may be administered to our troops for their protection against chemical and biological threats.[i]

    At the end of multiple hearings on Gulf War Syndrome and many inquiries into the DoD’s use of experimental and investigational drugs during the Gulf war, in 1997 Congress (finally) decided that enough was enough. Representative Patrick Kennedy (D, RI), introduced a bill on the floor of Congress to provide some small measure of protection for service members. In its original form, the bill imposed three requirements on the DoD: either prior to, or within 30 days of, administering an investigational new drug, the DoD would have to inform military members that

    1. The drug being administered is investigational;
    2. The reasons why the drug is being administered;
    3. The potential side effects of the drug, including side effects resulting from interactions of the drug with other drugs or treatments being administered to the individual.

    Representative Kennedy’s remarks made clear that the bill was the direct result of inquiries into the Gulf War and what he perceived as a DoD cover-up of possible chemical exposures of U.S. troops. He noted that the trust between soldiers and the government

    “has been called into question. One need merely read newspaper articles surrounding the Persian Gulf war to see what I mean. On February 28, the New York Times ran an article entitled: ‘Pentagon Reveals It Lost Most Logs on Chemical Arms;’ ‘Missing From Two Sites: Gulf War Veterans Now Raise Questions of Cover-Up or Criminal Incompetence.’”[ii]

    Mr. Kennedy went on to cite another article that revealed that the Army had been warned by the CIA five years prior (to the article) about the possible exposure of troops to chemical agents and that the DoD had claimed that it only became aware of the exposures the prior year. Additionally, Kennedy referenced the DoD and FDA negotiations that took place prior to the Gulf War regarding a waiver of informed consent detailed in the previous chapter. He criticized the DoD for failing to comply with the conditions the FDA had set forth in order to grant the waiver of informed consent that the DoD legally needed and had negotiated in order to use both pyridostigmine bromide and botulinum toxoid on troops. Oddly enough, however, Kennedy then seemed to concede that the DoD could now use investigational drugs without informed consent because “[u]nfortunately, for our troops, the threat of chemical and biological weapons have become an increasing reality[.]” Mr. Kennedy seemed to believe that, at the least, “the men and women who served in the Gulf War had a right to know that the vaccines administered to them were investigational” and that “[t]he same service members had a right to know about the side effects of the investigational drugs.”[iii] As an author’s note, I feel compelled to add that Representative Kennedy did swear an oath to “defend the Constitution of the United States of America against all enemies foreign and domestic” and “to bear true faith and allegiance to the same.” Which can only mean that either (a) Kennedy believed that it is perfectly fine for the U.S. government to experiment on its troops, or (b) he doesn’t know very much about the Constitution. (‘Both’ is also an acceptable and likely answer).

    To his credit, however, Kennedy did introduce the bill in order “to ensure that in the future our troops are informed of investigational drugs, and to help ensure that our service members can and will trust their government.”[iv] The legislation received some discussion on the floors of both the Senate and the House, always with reference to the Congressional investigations surrounding Gulf War Illness and the mistakes made with pyridostigmine bromide.[v] Finally, as part of the National Defense Authorization Act for fiscal year 1998 (from October 1997 to October 1998), Mr. Kennedy’s proposed bill became 10 U.S.C. §1107. In something that couldn’t be made up, within a year of this bill being approved and becoming law, Secretary of Defense William Cohen announced that he would begin the inoculation of all U.S. military personnel with the anthrax vaccine.

    As this vaccination program was kicking off, the Senate Armed Services committee was already calling high-ranking DoD officials to explain how the program was going to work in light of the Persian Gulf experience and even the then recent deployment of troops to Bosnia. In fact, members of the committee pointed to the Presidential Advisory Committee’s review of the DoD’s efforts in Bosnia and pointed out that they were deemed “an abysmal failure.”[vi] This committee even addressed the issue of how the DoD proposed to handle the administration of clinical protocols in accordance with FDA regulations. It is important to note that here the DoD was acknowledging that it had to comply with clinical protocol requirements of the FDA if it administered a drug in such a way as to render it an investigational new drug. An FDA official opined that “we [the FDA] believe that they [DoD officials] understand… [the need to comply with IND procedures]. We believe that they have the capability of complying with all of our IND rules and regulations.  As to whether they will comply in the next deployment situation, obviously we can’t predict that.”[vii]

    The Acting Secretary of Defense for Health affairs, Gary Christopherson, tried to assuage the concerns of committee members by admitting that the Bosnia experience[1] was a “situation where we believed we ought to be able to do an IND and do it well, it still did not come off 100 percent. It did not meet their standards. It did not meet our standards in there.”[viii] He went on to add that the DoD and the FDA were engaged in a “conversation” to improve their compliance with the FDA’s regulations. In a bit of backpedaling, Mr. Christopherson implied that there was some kind of agreement between the FDA and DoD that there would not need to be full compliance with the requirements of the Nuremberg Code, the FDA’s regulations, and the DoD’s own internal regulations. He offered that “[t]he one thing that I think both FDA and we have come to somewhat – not necessarily a conclusion, but close to – is that in real combat situations it’s very difficult if not impossible to do a full investigative new drug protocol.” This did not seem to arouse much comment from any of the Senators, despite the clear implication that DoD was not going to comply with the requirements for informed consent for an IND procedure. One other question not raised (of course) was how combat would be defined. Even if the DoD were granted a waiver for combat exigencies, would Bosnia and other peacekeeping operations fit the justification given for the Gulf War?

    At the same time that the Senate hearings were going on and the anthrax program (AVIP) was going forward, the FDA was also trying to determine if the interim rule that it had published to allow DoD to use investigational drugs without informed consent should become a final rule. That rule, granting the DoD waiver, was still “on the books” as the interim rule pending finalization. The FDA solicited comments by October 29, 1997. This means that (legally speaking) as late as autumn of 1997, the DoD still had a waiver from the FDA’s requirements of informed consent. The language of the rule was broad and did not specifically exempt just those two products, although that was the agreement reached in 1990. Now, as the DoD was preparing to use another investigational drug in Bosnia and not doing it particularly well, the FDA was asking whether or not the DoD should be allowed to maintain the waiver. This produced some interesting exchanges in committee hearings in Congress. In 1996, the Director of the FDA brought forward Ms. Mary Pendergast, a doctor at the FDA’s Center for Biologics Evaluation and Research (CBER), to answer the question about this rule.

    REP. NETHERCUTT:  So your conclusion five years later is that waiving the Informed consent requirements is acceptable?

    PENDERGAST: Yes, basically. It’s not the preferred option, but there are some products that you cannot ethically test. . .

    REP. NETHERCUTT:  Okay. I’m trying to get to now. . . as to why you feel it’s acceptable to do that.

    PENDERGAST: If there is another war —

    REP. NETHERCUTT: Which is prospective.

    PENDERGAST: Yes. If there is another war and if there is a circumstance where the military might need to give prophylactic treatment to its troops, then we would create simply the framework that would give them the opportunity to come to the FDA to ask for permission to waive informed consent. It’s not saying that we would waive it during peacetime; it’s not that we would automatically waive it, rather, we would create a framework that would permit them to ask for permission.

    KESSLER: I think the presumption is, if it is at all possible, you get informed consent. That certainly is my personal position.[ix]

    In this exchange, the head of the FDA, Dr. Ronald Kessler, asserts that informed consent would not be waived during peacetime at the same time that the FDA has on the books an interim rule that allows the DoD to waive informed consent, not just for combat, but also for the “the immediate threat of combat.”[x] How immediate would the threat have to be and what level of combat would it have to be? One can only envision that the DoD would get to make both of these determinations; certainly the FDA is not going to question a military officer’s determination that combat is imminent or immediate or of sufficient ferocity to be deemed combat.[2] Thus the rule is really no rule at all in terms of limiting the application of when the DoD can waive informed consent.

    In a 1997 Congressional hearing on Bioethics, this issue also came up by Dr. Arthur Caplan, a professor of Bioethics at the University of Pennsylvania. He offered quite simply that “the handling of the waiver with respect to the troops was unethical.”[xi] His opinion was that even with the waiver of prior informed consent, the DoD should have informed troops after the fact, if nothing else; that “the Defense Department – and those military agencies have not – did not do what they needed to do to after the fact inform people when they were exposed to innovative or experimental substances.”[xii]

    His second point of contention was that “there’s still been no formulation of a policy about what we do with respect to research on our troops. We don’t have it today. We didn’t have it six years ago. And I find it incredible that we have not had more than an interim rule to guide us with respect to research in the military.” At the time he said this, the FDA’s interim waiver rule for 50.23(d) was still in effect. Another doctor looked back even further and questioned the underlying assumption of the waiver, which, unfortunately, more people have not done.

    BENJAMIN WILFOND: I think I was not convinced this morning that they ever gave a clear reason why it was not feasible to have given – asked for consent in the first place. I mean, presumably if you ask the soldiers: You may be exposed to nerve gas. This medication may help you, but we really don’t know and would like to do a project. Would you like to participate? Most of them would probably say yes.[xiii]

    Some discussion ensued and there was the usual deference about the “quick” mustering up of forces, but Dr. Wilfond continued to question the assumption: “my point is that there’s still no – it’s not clear that they couldn’t have done it ahead of time either.”[xiv]

    This is an important issue that seems to get swept away amidst the rhetoric and large questions, but it is a particularly pragmatic point but deserves some attention. Every member of the Armed forces has, at one time or another, stood in line awaiting some inoculation. There is absolutely no explanation by these people in Congress why – if a member of the Armed Forces has to stand in line to get the shot – there would not be sufficient time to obtain the member’s informed consent? Even if the requirement for written consent were waived, if medical records have to be annotated anyway, how much more difficult would it be for the corpsman or medical personnel to hand a sheet out to everyone as they are standing in line? Or, how hard would it be to include a standard medical brief along with all of the other briefs that servicemembers have to receive when deploying, during which the ranking surgeon explains that this is the only possible treatment for the known threat. As both Doctor Wilfond and another doctor pointed out in their testimony to the Congressional committee:

    CAPLAN:  We took a lot of testimony at the Presidential Advisory Committee on this matter, and it was summed up fairly well by one of our people who came to testify to us who said, if someone is shooting very large bullets at you which may be filled with biological weapons, the likelihood of your refusing an antidote is zero.[xv]

    This may or may not be true: indeed, my own informal surveying concludes quite the opposite. The troops will take the known risks of being shot over the unknown risks of (yet another) DoD boondoggle with unproven chemicals being shoved into one’s body (a point to which I will return in detail later in this book). Despite these committee hearings, most of which had an FDA  representative attending and concurring in the recommendations of others, the FDA had still not issued a new rule to replace the interim waiver rule from the Gulf War in late 1998. By this time, Congress had held so many hearings on the issue of informed consent and military members that it moved from the committee level onto the floor of Congress.

    Representative Christopher Shays, a vocal opponent to the waiver granted to the FDA, rose as the speaker pro tempore in the House on June 16, 1998. He pointed out that there had been 13 hearings in three and-a-half years looking into Gulf War Illness. During this time, various agencies had testified in order to “try to get a handle on the problems that our Gulf War veterans have faced when they returned home. Out of the 700,000 that have returned, almost 100,000 have had some types of physical problems to deal with and have sought to have their illnesses be dealt with by the Department of Veterans Affairs.”[xvi] Mr. Shays noted that after 11 hearings, there had been a number of findings and recommendations made, among them that

    “the VA and the Pentagon did not properly listen to sick Gulf War veterans in terms of the possible causes of their illness[;] [that] there is no credible evidence that stress or Post Traumatic Stress Disorder caused the illnesses reported by many Gulf War veterans[; and] that Congress should enact legislation establishing the presumption that veterans were exposed to hazardous materials known to have been present in the Gulf War theater.”[xvii]

    Most importantly, Congressman Shays recommended that “the FDA should not grant a waiver of informed consent requirements allowing the Pentagon to use experimental or investigational drugs unless the President signs off and approves.”[xviii] This recommendation would become the cornerstone of a new version of Representative Patrick Kennedy’s first, more modest legislation. Interestingly, all it really did was seek a return to the “common rule” set forth in the Department of Defense’s own regulations, the Department of Health and Human Services regulations, the FDA’s regulations (prior to the waiver), the Nuremberg Code, and the federal statute passed which codified the Nuremberg Code. All of these regulations and laws have always stated that “the informed consent of the subject is absolutely essential” and all of them stated a presumption that “informed consent is feasible except . . .” in certain limited circumstances, usually when the subject was incompetent or incapable of giving consent or in a life threatening situation where the subject could not consent.[xix] As an example, the DoD’s own regulations state, unequivocally:

    Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.[xx]

    The FDA and DHHS regulations are identical, almost word-for-word. Additionally, the same regulation goes on to assure the subject that the only way that informed consent could be waived is if an appropriate Institutional Review Board, composed of doctors and other experts and members of the given community, determined that

    • The research involves no more than minimal risk to the subjects;
    • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
    • The research could not practicably be carried out without the waiver or alteration; and
    • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.[xxi]

    This language is hard to reconcile with the policy in the Gulf war that Mr. Shays noted that “our troops were ordered to take an experimental drug referred to as PB . . . It was used . . . as an experimental drug to do something it was not designed to do. Our troops did not have the option to decide whether or not to do this. They were under order. If they did not live by their order, they would be prosecuted by the military.”[xxii] Congressman Shays, looking back at that moment, probably had no idea that his words actually foreshadowed what was to come under the anthrax vaccination program that had just begun in April of 1998. Notwithstanding his intent to prevent just such occurrences – the threat of forced/coerced inoculation – embodied in the legislation that was to pass later that year, courts-martial were already beginning for those who would try to exercise the very rights being re-issued to them under the new version of 10 U.S.C. §1107.

    The 1998 version of 10 U.S.C. §1107 was passed as part of the National Defense Authorization Act for fiscal year 1999, in October 1998. The differences between the 1997 version and the 1998 version are startling and important to note, not only for their legal effect, but for what they reveal about the rational for making the changes. The original (1997) 10 U.S.C. §1107 required the Secretary of Defense to provide written notice to service members of the use of an investigational new drug or a drug unapproved for its applied use “unless the Secretary of Defense determines that the use of written notice is impractical because of the number of members receiving the investigational new drug or drug unapproved for its applied use, time constraints, or similar reasons.”[xxiii]  This means that the Secretary of Defense had almost unfettered discretion to determine that written notice was not feasible. The only condition or enforcement mechanism was that the Secretary was supposed to provide Congress a written explanation if written notice was not used. The 1998 version, however, in sharp contrast, would strike that language out (from “unless” to the end), thus eliminating anything except written notice.  The new version would then add one significant paragraph, (f) and change the current (f), the definitions section, to (g). The new paragraph, unchanged since 1998, reads as follows:

    (f) Limitation and Waiver.—

    1. In the case of the administration of an investigational new drug or a drug unapproved for its applied use to a member of the armed forces in connection with the member’s participation in a particular military operation, the requirement that the member provide prior consent to receive the drug in accordance with the prior consent requirement imposed under section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) may be waived only by the President. The President may grant such a waiver only if the President determines, in writing, that obtaining consent–

    (A) is not feasible;

    (B) is contrary to the best interests of the member; or

    (C) is not in the interests of national security.

    2. In making a determination to waive the prior consent requirement on a ground described in subparagraph (A) or (B) of paragraph (1), the President shall apply the standards and criteria that are set forth in the relevant FDA regulations for a waiver of the prior consent requirement on that ground.

    This portion of the statute vests the decision to use or not use investigational drugs with one person and one person alone, the President of the United States. While the President appoints a cabinet member, the Secretary of Defense, to be his representative on military affairs, this law specifically lifts the power to make these decisions out of the Secretary’s hands and placed it squarely on the President.

    3. The Secretary of Defense may request the President to waive the prior consent requirement with respect to the administration of an investigational new drug or a drug unapproved for its applied use to a member of the armed forces in connection with the member’s participation in a particular military operation. With respect to any such administration –

    (A) the Secretary may not delegate to any other official the authority to request the President to waive the prior consent requirement for the Department of Defense; and

    (B) if the President grants the requested waiver, the Secretary shall submit to the chairman and ranking minority member of each congressional defense committee a notification of the waiver, together with the written determination of the President under paragraph (1) and the Secretary’s justification for the request or requirement under subsection (a) for the member to receive the drug covered by the waiver.

    The crucial portion of this new law is that only the President could waive the requirement for informed consent. Furthermore, even if the Secretary wishes to request a waiver, he cannot delegate that request, putting him- or herself on the hook, as well, if something were to go wrong. The President could also only grant the waiver in writing, and then the Secretary has to submit a copy of the waiver and his justification for requesting it in writing to both the House and Senate Committees involved that have cognizance over military affairs AND appropriate the money for such operations.

    This section thus vests political liability for the decision to waive informed consent with the President. Second, it provides Congress with the weapon to veto the Presidential decision with its mightiest tool – control over the appropriations to conduct such an operation. While there is still an ongoing battle over the two provisions of the Constitution that vest control of the military in two different branches of government,[3] ultimately Congress could win such a battle by denying the funding for any military operation under its plenary power to appropriate money. Perhaps the most important aspect of the statute comes from the enabling public law. The National Defense Authorization Act for FY 1999, which passed and enacted the second version of 10 U.S.C. §1107, contained two notes that would affect any existing waivers of the requirement for informed consent. The first paragraph (paragraph (2) of the 1998 act) explains that the new paragraph (f) applies to any new operation involving service members. The second of these two clauses addressed the possible “grandfathering” of any pre-existing waivers and states that

    (3) <10 USC 1107 note> A waiver of the requirement for prior consent imposed under the regulations required under paragraph (4) of section 505(i) of the Federal Food, Drug, and Cosmetic Act (or under any antecedent provision of law or regulations) that has been granted under that section (or antecedent provision of law or regulations) before the date of the enactment of this Act for the administration of a drug to a member of the Armed Forces in connection with the member’s participation in a particular military operation may be applied in that case after that date only if –

    (A) the Secretary of Defense personally determines that the waiver is justifiable on each ground on which the waiver was granted;

    (B) the President concurs in that determination in writing; and

    (C) the Secretary submits to the chairman and ranking minority member of each congressional committee referred to in section 1107(f)(4)(C) of title 10, United States Code (as added by paragraph (1)) –

    (i) a notification of the waiver;

    (ii) the President’s written concurrence; and

    (iii) the Secretary’s justification for the request or for the requirement under subsection 1107(a) of such title for the member to receive the drug covered by the waiver.

    Thus, the statute not only looked forward to future operations, it also reached back and effectively wiped out the existing interim FDA rule and waiver that the FDA still had not changed. The FDA would update its regulations in May 1999, incorporating all of the requirements of 10 U.S.C. §1107, some 7 months after the passage of the act and some eight plus years after it issued an “interim” rule for Desert Storm.

    Endnotes

    [1] In the Bosnia deployment, the DoD vaccinated troops against a tickborne encephalitis with an investigational drug.

    [2] This is not a game of semantics, either. Our predecessor veterans in Vietnam, having spent time in the “Arizona Valley” near Da Nang or serving near the DMZ, might not characterize the role of our troops in Bosnia as “combat”, yet any time a bullet flies from a hostile rifle, there is the possibility for death and harm. The FDA is certainly not going to gainsay the military in such matters.

    [3] The Constitution, in Art. I, §2, names the President as Commander-in-Chief of the armed forces. Art. II, §8 grants Congress the power to make rules for the land and naval forces, to raise armies, and the power to make all necessary rules in carrying out its duties under Art II.

    [i] 143 Cong. Rec. E 637, April 10, 1997 (remarks of Representative Patrick Kennedy of Rhode Island).

    [ii] Id. See also https://www.nytimes.com/1997/02/28/us/pentagon-reveals-it-lost-most-logs-on-chemical-arms.html

    [iii] Id.

    [iv] Id.

    [v] See, e.g., 143 Cong. Rec. H. 9137 (Oct. 23, 1997).  Section 766 of the National Defense Authorization Act for fiscal year 1998 contained this bill under the subtitle Persian Gulf Illness (Subtitle F).

    [vi] U.S. Senate Committee on Veterans’ Affairs Holds Hearings on the Nomination of Togo West to be Secretary of Veterans’ Affairs and U.S. Biologic Vaccines for Gulf War Veterans.  Statement of Senator Rockefeller.  March 17, 1998.

    [vii] Id.  Testimony of Mr. Randolph Wykoff, Associate Commissioner for Operations, Food and Drug Administration.

    [viii] Id.  Testimony of Mr. Gary Christopherson.

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

    [x] 21 C.F.R. 50.23(d) (1990).

    [xi] House Government Reform Committee and Subcommittee on Human Resources Holds a Hearing on Biomedical Ethics, (May 8, 1997).

    [xii] Id.

    [xiii] Id.

    [xiv] Id.

    [xv] Id.

    [xvi] 144 Cong. Rec. H. 4616 (June 16, 1998).

    [xvii] Id.  Remarks of Congressman Shays.

    [xviii] Id. (emphasis added)

    [xix] See 32 CFR 216.107, 46 CFR Part 45, 21 CFR 50.23(d), 50 USC 1520a and The Nuremberg Code.

    [xx] 32 CFR 219.116 (2001).  These regulations have been in place since 1991.

    [xxi] Id.

    [xxii] 144 Cong. Rec. H. 4616 (June 16, 1998).

    [xxiii] 10 USC 1107 (1997).

  • Chapter 6 – The Gulf War and Its Experimental Drugs aka “Your Body is the New Battlefield”

    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.

  • Chapter 5 – The FDA, DHHS, & Vaccines: Anthrax Slides By

    The quality of a vaccine is closely linked to its manufacturing process, which must be rigorously controlled to ensure that batches of vaccines produced on different occasions are of reproducible and consistent quality. In general, quality is achieved by applying the current good manufacturing practice [cGMP] . . . Such principles also apply to the facilities and equipment in which products are manufactured.  Accordingly, vaccine production is very highly regulated to ensure that the products are of consistent quality and safe and effective for the purpose(s) for which regulatory approval was granted.[i]

    Before 1962, vaccines, drugs, and other such products did not undergo nearly the kind of scrutiny that they do today in order to become licensed.  It wasn’t until the thalidomide disaster of the 1960’s that federal regulation of drugs came to be what it is today. As of 2003, the Department of Health and Human Services (DHHS) is “United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.”[ii] This is a monumental undertaking and is why the DHHS is one of the largest government agencies with over 63,000 employees and an annual budge of $429 billion. It has a number of sub-agencies with their own areas of responsibility, including the Food and drug Administration. The history of these organizations bears some consideration because it is between the historical cracks in legislation and regulation that the current anthrax vaccine would slip.

    In 1906, the first Food and Drug Act was passed, authorizing the federal government to monitor the purity of foods and safety of medicines. The 1906 Act was fairly light, even inadequate by most standards. False statements made about a drug by its manufacturer (i.e., public advertising) were not considered as misbranding by the courts. Additionally, the Act did not grant authority to ban unsafe drugs. For a drug to be legal under the 1906 law, it only had to meet the standards for composition of the United States Pharmacopoeia or the National Formulary. The Bureau of Chemistry – the forerunner to the modern FDA – enforced this law.

    It wasn’t until 1938 that the Food and Drug Administration received broad statutory authority to regulate interstate shipment of unapproved new drugs for investigational use. This kind of federal regulation was a direct result of President Franklin Delano Roosevelt’s policies and the Great Depression. Prior to the Great Depression, the federal government exerted nothing even approaching the kind of regulatory authority that it does today.

    The Sulfanilamide Disaster of 1937 brought the first modification to the 1906 act. Soldiers originally used sulfanilamide as a treatment for wounds. In powder form it was sprinkled over a wound as an antiseptic, to prevent infection. [This is one of the substances the Nazi doctors used in experiments named in the indictment at the Nuremberg Trials. Thus, their defense that what they did differed little from previous U.S. experiments.] A manufacturer decided to expand the anti-infective use of the drug by mixing sulfanilamide with diethylene glycol – diethylene glycol currently enjoys a more popular following among American consumers as anti-freeze in car radiators. The manufacturer marketed the mixture of glycol and sulfanilamide as an elixir for sore throats. No clinical tests were performed prior to marketing. There were 107 reported deaths from this product.

    Subsequently, the Federal Food, Drug, and Cosmetic Act of 1938 was enacted, expanding the government’s control to include advertising and labeling of products.  More importantly, it authorized the Food and Drug Administration (for the first time) to establish a regulatory system for obtaining pre-marketing clearance of an investigational new drug. Manufacturers were now required to submit a new drug application (NDA) containing evidence that a drug was safe for its intended use. Despite this grant of authority, the FDA was fairly ‘light’ (by modern standards) in its regulation. These regulations, which remained in effect without change until 1962, left the protection of human subjects almost entirely to the discretion of sponsors and investigators. For example, it did not require a notice for conducting investigational trials to be submitted to the FDA; it did not require pre-clinical safety studies prior to administration of a drug into humans; and, notwithstanding the Nuremberg Trials, the 1938 Act did not require informed consent of test subjects.

    In 1962, thalidomide, a sleeping pill developed and widely used abroad for several years, was being studied for use in the United States. The FDA did not approve this drug for marketing in the U.S. because of the requirements in the Federal Food, Drug, and Cosmetic Act, and because of the refusal of an FDA medical officer, Dr. Frances Kelsey, to clear the drug on what she believed to be inadequate safety evidence provided by the manufacturer. Notwithstanding this, and even though the drug was restricted to investigational use in the U.S., the sponsoring pharmaceutical company widely distributed it to doctors for their use. [This practice continues to this day by some drug manufacturers.] Later, of course, thalidomide was learned to be a human teratogen which caused malformations in many European children. Children were being born without arms or with other severe deformities. A series of lawsuits demonstrated that, in general, prescribers of drugs had been relying on manufacturers for information pertaining to the drugs, and that this information in some instances had been based on inadequate testing, or even on deliberate falsification and deception. The Kefauver-Harris amendments of 1962 were finally enacted as a result of this incident.

    These amendments contained several important new provisions to the FD&C Act. First, it required that all clinical testing of investigational drugs be conducted under applications submitted to the FDA (Investigational New Drug Applications). Additionally, sponsors were required to submit reports of pre-clinical studies to justify their proposed clinical testing in humans, obtain informed consent from test subjects prior to their entry into a study, and report all findings resulting from the investigational studies to the FDA. Second, Good Manufacturing Practices (GMP) were established. Any drug not produced in accordance with CGMP would be considered adulterated. Prescription drug advertising was also placed under the supervision of the FDA.

    Finally, the 1962 amendments required that all new drugs, in addition to being safe, must be shown to be effective for their intended use, prior to marketing. The standard for scientific evidence acceptable for demonstrating substantial effectiveness was defined by Congress as:

    adequate and well controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could be fairly and responsible be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling.[iii]

    The FDA had actually proposed new regulations before the 1962 amendments were enacted, and it issued final rules three months after the new law took effect. These regulations are the broad outlines of the investigational drug regulatory system that remains in effect today.

    The former Division of Biologics Standards (DBS), currently the Center for Biological Evaluation and Research (CBER), was involuntarily transferred to the FDA from the Public Health Service in 1973. Its transfer was triggered by the failed Polio vaccine release, on the grounds that old-world style management encumbered it. The DBS was viewed as incapable of protecting the public health because it was too closely involved with the industry it was supposed to regulate (so-called “unholy marriages” between industry and government regulation). This was the same problem that existed with a number of industries and agencies, including the Atomic Energy Commission.  The same agency was tasked with both promoting and regulating a given industry. The AEC was partly responsible for radiation exposure experiments on troops in the 1940’s.  [AEC regulators actually wore protective suits during experiments while soldiers were completely exposed to the radiation from atomic bomb detonations.]

    An important slip occurred between the time of the passage of the Kefauver-Harris Amendments and the time when the Division of Biologics Standards was transferred from the National Institute of Health’s/PHS’s DBS was put under the FDA.  The FDA was charged with enforcing the Act and passing regulations to do so – which it did. However, a certain class of drugs, biologics (which includes vaccines and other blood products), were under the auspices of the DBS, which was under the Public Health Service, a different agency. Unfortunately, because of the hodgepodge manner in which agencies had sprung up, the DBS, which saw itself as controlled by the Public Health Service Act and also sought to promote the industry it was regulating, did not necessarily require efficacy data for approval of its products, namely, vaccines. Thus, it was not until some ten years later when the DBS was transferred under the FDA (because of the failed polio vaccine release mentioned above) and became the Center for Biological Evaluation and Research (CBER) that vaccines were truly required to show efficacy data – notwithstanding a law requiring it some ten years earlier.

    When CBER finally came under the FDA, all of the previously licensed vaccines that had been given without the required efficacy data would be reviewed and placed into categories. Category I products were considered safe, effective, and not misbranded.  Category II products were unsafe, ineffective, or misbranded. Category III products were split into A and B. Category IIIA products had inconclusive data, but the product would remain on the market pending further study and IIIB drugs were data inconclusive, product to be removed from the market. This review would take an incredibly long time and the review of the anthrax vaccine, licensed in 1970 without any efficacy data, would not be done until 1985.

                                                                                                                                                                                                               

    With the creation of so many federal agencies came an increase in the administrative regulations over the industries the agencies were set to watch. The Supreme Court repeatedly deferred to these agencies’ decisions and upheld their regulations. Agencies such as the Equal Employment Opportunity Commission and the Food and Drug Administration (FDA) had increasing roles in their respective areas of concern. As part of the passage of regulations in its area of concern, the Agency first proposes a rule in the federal register for a period of time and invites comment on the proposed rule. The rule is then viewed in practice and left open for comment, then, if necessary, the rule is amended and a final proposed rule is ultimately published. While these regulations do not have the same force and effect as law, if they do not conflict with any preexisting laws and are not inconsistent with the agency’s charter, these rules in effect become law because they are binding upon persons, corporations, or agencies operating in the particular agency’s area of concern.

    The rule regarding testing on human subjects passed with little, if any, comment. Who could disagree with the principle that “no investigator may involve a human being as a subject in research . . . unless the investigator has obtained the legally effective informed consent of the subject[.]”[iv] In fact, almost every federal agency adopted the same or similar version of the regulation regarding human subjects and informed consent. This rule was passed by the Department of Health and Human Services (DHHS) in 1981. The full version of the FDA’s regulations are virtually identical to the full DHHS ones.  They read that

    no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.[v]

    Even the Department of Defense adopted regulations with much the same lack of fanfare in 32 C.F.R. 219.116-117. These regulations state, just as above, that “[e]xcept as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.” The 2003 version of the DoD regulations are identical to the FDA’s.  Everyone seemed to agree that when it comes to experimenting on human subjects, consent was a prerequisite. As an important corollary, DHHS also published some definitions of what research would be covered by the informed consent requirements. It is an extremely broad definition.

    Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes . . . Research subject to regulation, and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration).[vi]

    This last “for example” is critical, as it repeats and reinforces the FDA’s requirements that using Investigational New Drugs for the purpose stated in the New Drug Application is research requiring informed consent. This deserves some explanation as it is crucial to understanding one of the reasons why the anthrax program was illegal.

    The FDA regulates the manufacturers of drugs through the licensing and regulatory process, but it does not control the end-user of the product – i.e. a doctor, or in this case, the Department of Defense. Vaccines are subject to the requirements of the FDA under the Food, Drug and Cosmetic Act (FDCA, Title 21, Chapter 9) as prescription drugs and the requirements of the Public Health Service Act (42 U.S.C. 262) as a biologic. The two acts are not exclusive, but complimentary. Typically, a manufacturer submits a proposed New Drug Application with the FDA setting forth what “clinical protocol” or experiment it is going to do in order to demonstrate the efficacy of its drug. At the same time, the manufacturer also must comply with FDA regulations for how its manufacturing process takes place. Normally an approved drug must have a dual part license, a PLA (product license amendment) for the drug, and an ELA (establishment license amendment) for the facility. This ensures that the product meets the four necessary prerequisites for licensing:  sterility, safety, potency, and efficacy.

    The ELA helps ensure that the drug/biologic is sterile in its manufacturing process and potent. The FDA regulates this process in the facility by enforcing CGMPs (Current Good Manufacturing Practices). These practices are industry practices surrounding such procedures as sterility of the filtering systems, handling of the material, and random testing of the finished product to ensure uniformity from batch to batch. Potency is a good measure for quality control and to ensure efficacy of the manufacturer’s claims and proposed advertising. If random samplings of different batches reveal widely differing potency levels, it calls into question the consistency of the manufacturing process (a quality issue) and whether the drug can support the claims of efficacy. FDA inspectors, supposedly experts in the field, go check the facility to ensure compliance.

    The PLA sets forth the clinical protocol for the product. This includes what studies and data the manufacturer will use to demonstrate effectiveness. In other words, a company cannot simply claim they made a product cleanly and safely, that covers the ELA – one half of the license – they have to show the product does what it is advertised to do. This PLA will set forth how the product will be used (or has already been used) and the data from those controlled studies. Initially, in most cases, animal studies and basic research will be used to gather data. The company will then submit a New Drug Application (NDA), for completely new drugs, or an Investigational New Drug (IND) application for drugs already licensed that the company is seeking to modify somehow.  The PLA, and ultimately license for a drug, is so specific, that any change requires a modification to the existing license. The PLA gives the company an “indication” for using the drug. The “indication” in the license will include the route of administration of the drug (taken by injection or by mouth, for example), the number of shots or pills to be taken (twice daily or once a month?), what form it will be in if necessary (pills, liquid, caplets), dosage (20, 30 or 40 mg, for example), and what exactly the drug is designed to prevent, cure, or ameliorate.

    In the typical course of business, the drug will have advanced from the “experimental” stage to the Investigational New Drug (IND) stage, whether it is a new drug or an existing licensed drug, where some animal studies or other data exists indicating the drug’s likely effect. At this point, in order to gain licensure and prove efficacy in human beings, there must be two well-controlled human studies to prove efficacy of the drug. This point cannot be overstated: before a manufacturer can prove efficacy of a drug for its licensed indication, it must have two human studies. This means that no company manufacturing a drug as a pretreatment for chemical warfare can ever get beyond the Investigational stage. As two Army doctors pointed out in an article in 1992,

    For products designed to protect against chemical and biological agents, a clear demonstration of efficacy would require exposure to humans to these lethal agents. Since this practice would be unethical and immoral, these products never advanced beyond the investigational stage.[vii]

    This requirement proved to be the insuperable obstacle for any DoD contractor trying to make a vaccine as a pretreatment for biological warfare agents – because it would be unethical to test drugs on human beings as pre-treatments for chemical warfare.  HOWEVER, if there were an already existing vaccine that could be used as a pretreatment for a chemical or biological agent and it was licensed for some other purpose, the DoD could use that without being subject to FDA regulation, which brings us full circle to the question of whom the FDA regulates.

    The FDA requirements above all apply to manufacturers, not the end-user. Thus, as an example, let us suppose that there is a drug we will call PB that is used to block a particular chemical from being produced by the brain in patients with a certain disease, we will name MG. Let us suppose this has been licensed for many years and shows no side-effects on these patients in the dosages they take for 35 years of licensed use. Now, let us suppose that the DoD gains knowledge about a certain nerve agent named SM that, as its mechanism of attack, causes the brain to massively produce the same chemical that our licensed drug, MG, blocks the production of. The agent is usually delivered in bombs in aerosol form. The DoD could, it would appear, buy large quantities of this drug and give it to troops in order to prevent the effects of the nerve agent SM.  This use of the drug is considered off-label and investigational. This is because the drug is normally used (and has been licensed) to fight a particular disease, not be a prophylaxis against a nerve agent, and so there is no licensed indication for the drug as a pretreatment as a nerve agent. There is certainly no proof of efficacy for this use. Thus, the manufacturer could certainly not advertise the product as a pretreatment for the hypothetical SM without incurring the regulatory wrath of the FDA, but what about the DoD? The DoD could use the drug in such a fashion, provided it obtained informed consent from the individuals it was giving the drug to. While the FDA would have no way to regulate an end-user relationship normally, the FDA is responsible for monitoring IND applications and clinical trials under an IND application. If the above drug were not licensed fully and the DoD intended to use the drug and track who it was given to and when and how many times and record that in servicemembers record books, that would be research as defined under FDA, DHHS, and even the DoD’s own regulations.  Research requires informed consent. Such administration of the product, vaccine or drug, would have to be performed under an IND clinical protocol.

    On the eve of the Gulf War, the DoD was up against the regulations requiring informed consent, with the concomitant intelligence and history showing that Saddam Hussein (a) possessed such agents and (b) had previously used chemical (and perhaps biological) weapons on minorities in his own country. The DoD therefore lobbied the FDA for a waiver from the requirements of Rule 50.23(d) of the FDA’s regulations.[viii] This would happen for a number of licensed, investigational, and even experimental products, with servicemembers having no say in the matter.

                                                                                                                                                                                                               

    Endnotes

    [i] GAO Report T-NSIAD-99-148 (April 29, 1999)

    [ii] Quote from the DHHS website, http://www.hhs.gov/about/profile.html.

    [iii] 21 U.S.C. §355(i) (2000)

    [iv] 45 C.F.R. 46.116 (2000)

    [v] 21 CFR 50.20 (2000)

    [vi] 45 CFR 46.12 (2000)

    [vii] Col. Garland E. McCarty and Lt. Col. Gregory P. Berezuk, Military Medicine, Vol. 157, p. 404 (August 1992)

    [viii] 21 CFR 50.23(d) (1990)

  • Chapter 4 – Judicial Remedies in Our Republic?

    The bar created by Chappell – a judicial exception to an implied remedy for the violation of constitutional rights – surely cannot insulate defendants from liability for deliberate and calculated exposure of otherwise healthy military personnel to medical experimentation without their consent, outside of any combat, combat training, or military exigency, and for no other reason than to gather information on the effect of lysergic acid diethylamide [LSD] on human beings.

    No judicially crafted rule should insulate from liability the involuntary and unknowing human experimentation alleged to have occurred in this case. Indeed, as Justice Brennan observes, the United States military played an instrumental role in the criminal prosecution of Nazi officials who experimented with human subjects during the Second World War, and the standards that the Nuremberg Military Tribunals developed to judge the behavior of the defendants stated that the ‘voluntary consent of the human subject is absolutely essential … to satisfy moral, ethical and legal concepts.’ If this principle is violated the very least that society can do is to see that the victims are compensated, as best they can be, by the perpetrators. I am prepared to say that our Constitution’s promise of due process of law guarantees this much.[i]

    United States v. Stanley, 483 U.S. 669, 709-10 (1987)(O’Connor, J., dissenting)(some citations omitted).

    There are both moral and legal arguments to be made for the proposition that the actions detailed in Chapters 1 and 2 should be allowed. To be explicit, I am speaking of the idea that the Government – the State – has (1) a right to the compelled obedience of its citizens, and (2) the right to the lives of its citizenry in defense of the State. Historically, this has been the default state of affairs for most of what we know of recorded human history. The anthropological and archaeological record strongly suggests that from Africa to Asia to Europe to South and North America, the general organization of human beings has almost always involved a leader, chosen usually by some combination of martial prowess and/or political savvy, with rule enforced upon the rest of the tribe/culture/society through several mechanisms, including cultural/social pressure, including religion, and force. Regardless of the variations, the underlying idea has always been that the people owe their allegiance to the ruler and the larger culture. They could be conscripted to fight in the King’s, Pharoah’s, Queen’s, Caesar’s, The Great Khan’s, Czar’s, Napoleon’s, Comrade Stalin’s Armies against any enemy of the homeland, and forced to march to their certain death by elephant, Russian winter, or German MG-42. The unthinkable, but unassailable, logic follows that if the State can order you to your likely death, or maybe just a group of you as a feint to cover for a larger assault somewhere else – if you can be sacrificed for the benefit of others, why can’t someone, the State, make the same calculus by doing some experiments on you? If you can be ordered into battle as a soldier where you could die, or even be subjected to the enemy’s chemical weapons, then why can’t the military hierarchy sacrifice some of you good chaps for the sake of others, eh? Isn’t this what military commanders do in battles all of the time?

    The political systems under which this is still the case – today – are too numerous to mention.

    Fortunately for United States citizens, that entire idea was explicitly rejected in the American Revolution; that is the great moment of “American Exceptionalism.” The Declaration of Independence’s most trenchant historical observation is coupled with its boldest claim: “that governments are instituted among men, [and] deriving their just powers from the consent of the governed.” Governments are not extensions of the Divine Will; political power does not derive through familial claim, inheritance of religious authority, or other ‘farcical aquatic ceremonies.’ At the time, it was the most radically egalitarian idea that had ever been proposed, on a par with Martin Luther’s heresy to the Catholic Church’s authority. It stripped all of the mysticism and power away from government agents of every kind; all of the King’s Men declaimed as equal to even the lowest yeoman farmer, dock worker, deckhand, or wheelwright.

    That is also what seems to have gone missing in our culture, and why even in the United States there are still people in respectable circles who feel that soldiers give up their rights when they join the military and therefore, have no grounds to complain of their treatment. This is not confined to those outside of the military, either; it is a common misperception, even among active servicemembers. If servicemembers enjoy less than the full rights that other U.S. citizens enjoy: diminished First Amendment protections, for example, because they can’t protest their Commander’s decisions, or lower “expectations of privacy” in the Fourth Amendment context (see mandatory drug testing), then the logic somewhat follows that perhaps servicemembers can be experimented upon without having any grounds for relief.

    Unfortunately for servicemembers, these arguments get additional fuel because they have more than a slight legal basis. There is a specific exemption in the Fifth Amendment of the U.S. Constitution for “those serving in the land or Naval forces.” There are legal scholars who argue that servicemembers do not enjoy the same Constitutional rights as ordinary citizens because of that specific exception to the Fifth Amendment’s grand jury requirement for an indictment. There is still some debate over whether the founders intended all other protections to apply to servicemembers or if that exemption was a recognition that servicemembers were less than full citizens. The Supreme Court has never issued a definitive ruling on whether the Bill of Rights applies to servicemembers wholesale, either. There are also two Supreme Court decisions that hold that servicemembers have no right to a trial by jury. These decisions are particularly odd because neither of the cases involved servicemembers at all. In one case, at the close of the Civil War, a man living in Indiana was tried and convicted by a military commission and sentenced to be hanged. A local grand jury found no evidence against him and was dismissed without an indictment being handed up. While in jail he petitioned for a writ of habeas corpus that eventually went to the Supreme Court. The opinion, in eloquent language, extols the virtue and necessity of the trial by jury and then in one backhanded sentence mentions that every U.S. citizen, except servicemembers, enjoys that right.[ii]

    The second decision, handed down in World War II, involved German saboteurs caught sneaking into the U.S. to commit espionage. Once again, while having nothing to do with the case, the Court manages to mention that only servicemembers have no right to a trial by jury.[iii] Ultimately, Congress fixed this with the comprehensive Uniform Code of Military Justice, which gives servicemembers the right to a trial by jury, albeit a somewhat different method of jury selection than in civilian courts. Nonetheless, these kinds of decisions and the impression they convey is that servicemembers are on a different constitutional footing than other U.S. citizens.

    The Court of Appeals for the Armed Forces, the highest military appeals court (subordinate only to the Supreme Court of the United States in military cases), has, in many cases, spoken in broad terms about the protections afforded to military members and has rejected the notion that particular Constitutional rights do not apply per se to military members. The court has instead held that a particular right, such as the Fourth Amendment’s protections, for example, apply ‘differently’ in the unique circumstances of the Armed Forces.[iv] In a 1995 case, the Court of Appeals for the Armed Forces noted that

    The administration of military justice is rooted in inherent fair play and justice that prevail under the Anglo-American system of law.  ‘In defining the rights of military personnel, Congress was not limited to the minimum requirements established by the Constitution, and in many instances, it has provided safeguards unparalleled in the civilian sector.’ The broad constitutional rights that servicemembers enjoy spring from the fundamental principle that they do not lay aside the citizen when they assume the soldier.[v]

    These kinds of statements would tend to indicate that servicemembers may enjoy the same rights as any citizen, perhaps even more, depending upon what Congress has granted… or those statements could simply could be propaganda, legal pablum for judge advocates and the small legal community around the military that even cares about such legal arcana.

    The fine legal question for servicemembers, relevant to the issue about the anthrax vaccine program, is whether or not there is a Constitutional right, or other right given by Congress, to be free from forced vaccination with an unlicensed or experimental drug. The more general question of whether or not a service member can be punished if he refuses a mandatory routine vaccination was answered in United States v. Chadwell in 1965. In that case a Marine refused to take the smallpox, typhoid, paratyphoid, and influenza vaccine, on religious grounds. The Court found against him and found the order lawful. For some people, this means that the anthrax vaccine program is perfectly valid, end of story, close the book, and let’s all go home.

    Let’s not be done with it so fast, however. First, there are a number of important differences between that order and the current anthrax program. Part of it has to do with the routine nature of that vaccine, meaning that it was already being administered to the entire U.S. population, while the anthrax vaccine had now been so administered. Second, the Marine in that case refused to take the routine shot for religious reasons. Almost none of the servicemembers refusing the anthrax vaccine were relying upon religious reasons. A third important difference was that the smallpox and other vaccines were not being administered as pretreatments against chemical warfare; they were being given for the same reasons as they were being given to the nation at large.[1] Finally, there was – and still is – a massive lesson that was learned as a result of the First Gulf War in 1990-1991 that changed the legal landscape around d this exact issue.

    Prior to the Gulf War, there had never been an inoculation offered as a treatment against chemical warfare.[2] The current anthrax vaccine is a part of the new era of chemical-biological defense. In prior instances, noted in Chapter 1, when military members were harmed by the actions of other soldiers, either military doctors or their commanders, if the military would take no action to redress the wrong, private legal action appeared the only way to go. Servicemembers who learned that they had been given experimental drugs sued the government for monetary damages for their health complications as a result of the experiments performed upon them. These types of suits are called tort suits. Tort is the French word for wrong and under Anglo-American law, it is one means of legal redress for harms suffered by a citizen. Juries may award actual damages for the harm suffered and punitive damages as a punishment to the wrongdoer and as a deterrent to others who would do the same.

    A U.S. citizen can also file for damages for a Constitutional violation, pursuant to a Supreme Court case named Bivens v. Six Unknown Named Agents, 403 U.S. 388 (1967).  In that case, Bivens alleged that FBI agents came into his apartment without a warrant or probable cause, searched his house from one end to the other, arrested him and ultimately charged him with narcotics violations. He sued in district court for damages for the violation of his constitutional rights. The courts below dismissed his suit on the grounds that he had no cause of action, but the U.S. Supreme Court ultimately held that he could sue government agents for the violation of his civil rights. Today, there is a specific statute that allows citizens to sue government agents who commit violations of their constitutional rights. See 42 U.S.C. §1983.

    There would at least appear to be a number of legal remedies available to citizens, including servicemembers, if they can prove some legal harm, either in a regular civil suit with injunctive relief or damages, or if there is a Constitutional violation under Bivens or §1983. This would be true, but for a legal concept known as sovereign immunity and the Feres doctrine.

    The Feres doctrine is named for a famous Supreme Court case[vi]  and relies upon a concept in British law known as sovereign immunity. The syllabus at the beginning of Feres explains the concept this way:

    While the political theory that the King could do no wrong was repudiated in America, a legal doctrine derived from it that the Crown is immune from any suit to which it has not consented was invoked on behalf of the Republic and applied by our courts as vigorously as it had been on behalf of the Crown. As the Federal Government expanded its activities, its agents caused a multiplying number of remediless wrongs – wrongs which would have been actionable if inflicted by an individual or a corporation but remediless solely because their perpetrator was an officer or employee of the Government. Relief was often sought and sometimes granted through private bills in Congress, the number of which steadily increased as Government activity increased.[vii]

    In short, the general principle was that no one could sue the Crown because the government creates or grants the rights of its citizens. Despite our Revolution to be free of British rule, in the earliest years of our republic, our courts took their cue from decisions in the British courts. A simple way of explaining this is that if an ordinary citizen ran over a child due to his own negligence, he would be liable in tort law, and perhaps criminally. Contrariwise, if a government agent driving a government truck did the same thing, there would be no relief for the parents if they sued in court. The only way to get relief in the early years was for a citizen to get his or her representative to put a private bill before either the state or federal legislature and for that body to consent to be sued. Eventually, the United States Congress passed the Federal Tort Claims Act as a comprehensive response to some of the arbitrary and unfair results produced when government agents caused serious harm to citizens. The Federal Tort Claims Act sought to relieve some of these inequities. It spells out who can sue the federal government and under what circumstances. In some cases, it even delineates what the maximum amount is that can be received for certain harms.

    The Feres decision actually involved three distinct cases, but the Supreme Court combined them for one decision, named after the lead case. In one of the other cases, a soldier in the army had abdominal surgery. Eight months later, an additional surgery removed a thirty by eighteen-inch towel labeled “Medical Department U.S. Army” from his stomach. His suit against the Army doctor for negligence was denied by the Supreme Court, whereas it would have been what lawyers affectionately call a “slam dunk” if it had been in the civilian context of medical malpractice. The Feres case held that military members were not within the class of persons covered by the Federal Tort Claims Act.  This means, in short, that military members cannot sue the government for harms suffered while on active duty by the tortious conduct of other servicemembers, no matter how egregious the wrongdoing.[viii]

    There have been many subsequent cases, law review articles, and much philosophical debate, questioning both the logic and the viability of the Feres doctrine.  In fact, there have been a number of bills introduced in Congress to overturn the Feres doctrine.[ix] The case quoted at the opening to Chapter 2, United States v. Stanley, is worth reconsidering as it addresses both the Feres doctrine and the ability of servicemembers to sue for civil rights violations (a Bivens claim in the military context, first announced by in a case called Chappel v. Wallace).

    The Feres case, like most cases, is subject to either a broad or a narrow interpretation and can be differentiated on a factual basis or on the basis of its legal holding, that is, the legal principle which applies to the given set of facts. The Feres court held that “the Government is not liable under the Federal Tort Claims Act for injuries to servicemen where the injuries arise out of or are in the course of activity incident to service.”[x] The legal justification for this was that servicemembers were not within the class of persons allowed to sue under the Federal Tort Claims Act. In U.S. v. Stanley, though, Master Sergeant Stanley was experimented upon, given LSD without his knowledge or consent, and these experiments were subsequently covered up by those in the Army who had administered the drug to him. Being slipped a mickey, as the old saying goes, doesn’t seem to quite fall within ‘arise out of’ or ‘in the course of’ activities of the military. Notwithstanding the 1977 hearings, during which members of the Senate noted that “the Justice Department and the Courts have their proper role to play”, a bare (5-4) majority of the Supreme Court found that MSgt Stanley had no grounds for relief, either under the Federal Tort Claims Act or under a Bivens claim for violations of his Constitutional (civil) rights.  The Court held that

    the reasoning . . . that the special factors counseling hesitation – the unique disciplinary structure of the Military Establishment and Congress’ activity in the field – extend beyond the situation in which an officer-subordinate relationship exists, and require abstention in the inferring of Bivens actions as extensive as the exception to the FTCA established by Feres and United States v. Johnson.  We hold that no Bivens remedy is available for injuries that ‘arise out of or are in the course of activity incident to service.’[xi]

    And yet, there it is, stated as if it were a fact, that being unknowingly experimented upon is now an activity ‘aris[ing] out of or… in the course of’ one’s service; the Feres doctrine barred MSgt Stanley’s tort action and his claim for the violation of his civil rights.

    The fact that the Court found against MSgt Stanley on the tort claim is perhaps not surprising given previous cases involving the Feres doctrine. What is especially shocking is that Chappel v. Wallace involved fairly clear racial discrimination and the Supreme Court had no trouble finding that racial discrimination was so terrible that the Court would intervene and allow intervention and relief from the courts, but being experimented upon without one’s consent, like a lab animal? No problem at all!

    The fact that the Supreme Court found that MSgt Stanley had no (military) Bivens’ claim is tragic, because it means that servicemembers’ most fundamental rights may be violated wantonly and they have no redress in the civil courts of this country.[3] This holding does have one further point to it. The Court, in finding that there were special factors counseling hesitation, apparently believed that the right of informed consent is of a Constitutional stature. Logically speaking, this is a necessary prerequisite for a Bivens’ claim: that there had to have been the violation of a Constitutional right. If not, there would have been no Bivens’ claim at all and MSgt Stanley’s claim would have been summarily dismissed, which is not what the Court did. Instead, the Court found that the Bivens’ claim could not go forward because of the ‘special factors’ that give the Court pause – namely military discipline – but not that there was no Bivens’ claim stated.

    Justice Sandra Day O’Connor, in her dissent in Stanley, took a different approach and found, quite simply, that “conduct of the type alleged in this case is so far beyond the bounds of human decency that as a matter of law it simply cannot be considered a part of the military mission.”[xii] Unfortunately, what Justice O’Connor and the American doctors at Nuremberg recognized as “conduct beyond the bounds of human decency” now had a new get-out-of-jail fee card in the majority’s lens: as long as it can be tied to the military mission. Less than three years later, on the eve of the Gulf War, it was to be repeated on a larger scale, this time not only with the aid of doctors, but with lawyers, replete with waivers, lobbying, and in the Nineties, public affairs officers! With decisions such as Feres and Stanley in hand, servicemembers would again be prevented from turning to the courts for relief and the law of unintended consequences would again rear its ugly head.

    Endnotes

    [1] In an interesting aside, the Supreme Court has found that the state can compel ordinary citizens to take a vaccine in a case called Jacobsen v. Massachusetts, 197 U.S. 11 (1905).

    [2] I treat this more fully in Chapter 6 on 10 U.S.C. §1107.

    [3] The Supreme Court left open the very slight possibility of injunctive relief or declarative judgments for servicemembers.  An important point in current military-legal affairs

    [i] United States v. Stanley, 483 U.S. 669, 709-10 (1987)(O’Connor, J., dissenting)(some citations omitted).

    [ii] See In re Milligan

    [iii] Ex Parte Quirin,

    [iv] Both the Supreme Court and the Court of Appeals for the Armed Forces have mentioned this “different” application of Constitutional rights.  See, e.g., Greer v. Spock, 424 U.S. 828 (1976); U.S. v. McCarthy, 38 M.J. 398 (C.M.A. 1993).

    [v]  U.S. v. Manuel, 43 M.J. 282, 286 (C.A.A.F. 1995).

    [vi] Feres v. United States, 340 U.S. 135, 139-40 (1950).

    [vii] Id.

    [viii] Id.  The soldier’s name was Jefferson.

    [ix] Deborah Funk, Bill Would Let Service Members Sue Over Medical Malpractice, Marine Corps Times, Aug. 27, 2001, p. 20.

    [x] Feres, at 136.

    [xi] Stanley, at 688-89 (internal citations omitted).

    [xii] Stanley, at 709.

  • Chapter 3 – The General Did What?

    “Hey D, you got a minute?”  I looked up from behind my computer.  I must have betrayed a look of impatience, because Justin looked back at me and said “What?”

    “I’m sorry, man. Sure, what’s on your mind?” I pushed back from my desk and Justin dropped all of his six-foot, two-hundred five pounds into a chair. Justin Constantine and I had gone to Naval Justice School together back in Newport, Rhode Island. All of the sea-services, the Navy, Marine Corps, and the Coast Guard, send their lawyers to NJS for ten weeks of training in military Administrative law, Criminal law, and Civil law, with a heavy emphasis throughout on practical application and trial advocacy. I hadn’t known Justin that well as he was a single, brand new First Lieutenant, and I was a relatively senior Captain, married with four kids, a year or two away from being on the selection/promotion board for Major. Despite that, when we found out that we both had orders for Okinawa (as did another classmate of ours) out of Justice School, I made an effort to take them both under my wing. As it turned out, Justin and I both got orders for the Defense shop and after long days as brand new criminal defense attorneys together, we also found out we shared a common love of rugby – and drinking beer – which appear together often enough to seem like co-dependent gene alleles.

    “Well, you know I got detailed to those three anthrax refusals from up North, right?” I nodded in reply. Up north referred to Camp Hansen, about an hour north from where we were at Camp Foster. While Camp Foster contained a lot of headquarters and support units, Hansen tended to have combat units like infantry battalions, an artillery regiment, and other front-line trigger-pullers. My assigned office was technically up there in the smaller Legal Services Support Team building, but I kept getting assigned cases in the south because of the fact that the Third Marine Air Wing was there and my boss always seemed to think me being a former pilot would somehow help the Marines who got into trouble in the Wing. It didn’t seem that way to me.

    I knew all about the anthrax cases up north; in fact, I had privately lobbied our boss, Major John Woodworth to give them to Justin because to that point the Boss was only giving him Administrative separation boards, no courts.

    “J.R., I know Justin is new, but he’s solid, and I have the other anthrax cases. These are a great way for him to get his feet wet and we can work on them side-by-side.” I was sitting in the one other chair in his small office in the Defense wing of the Legal Services building. I presumed to use his first name in private because we had known each other on a first name basis when we had both been Captains; I had been interning as a prosecutor at Camp Lejeune at the time, a couple of years earlier.

    The vagaries of our different career tracks made him senior to me, although we had been commissioned around the same year. In order to recruit lawyers, the Marine Corps, and all of the armed services, have to offer incentives because there the pay of a typical Marine officer is in now way comparable to what even a new attorney could get on the open market. One of the ways the military made up that deficit is through a fiction known as “constructive service.” A law student who signs up to be a judge advocate actually gets a reversion back to the date they signed up once they’ve completed training; which means that upon completion of Basic School and Justice School, a guy or gal with only months in service gets promoted to First Lieutenant and then is in zone for Captain, something that usually takes four to five years for the typically accessed officer. This occasionally creates friction within the Marine Corps’ rigid hierarchy because a Marine lawyer walking around with Captain’s bars may have 9 to 18 months of actual, real-life experience and time in the Corps, compared to a ‘regular’ line officer Captain who has been through two promotion boards, several deployments, and could have as much as eight or nine or ten years of service. After a few years it all irons itself out, but it’s a difficult row to hoe for the new attorneys, too. They’re frequently treated as ‘less than’ officers by those who know the system. JR had come in the same way, but he now had something like 8 years of actual time in, same as me, but his JA “reversion back” made him now a Major.

    “Well,” J.R. had begun in his usual southern twang, “he’s gotta mind his clients, and you gotta mind yours, but these should all wind up as Summary Court, Board waivers anyway. Help him out and let me know how it goes.”

    “Wilco, sir. Thank you.” I stood up to attention in front of his desk briefly, spun smartly on my heel and toe as if we were doing an about face on the parade deck, and marched out of his office in an exaggerated high step, to his snickering.

    Now with Justin in front of my desk, I squinted to think of the case names.

    “Stone-something, right? Not Stonehenge, but…?” I tried to remember from our last defense meeting.

    “Stonewall,” Justin supplied, either missing or ignoring the joke. I knew something was on his mind.  “I just got a call from one of my clients and checked out his story with some other sources. You’ll never believe what happened.”

    “Your guy confessed to the Kennedy shooting?” I didn’t even smile. He looked frustrated in return. “Okay, okay. I’m sorry. What happened?”

    “All three of my guys got called into a meeting with the Commanding General for Third MarDiv.” I raised my eyebrows and sat forward. It wasn’t very often that our clients got called into the Division Commander’s office for a chat. “So, of course, the Sergeant Major’s in there, the Division SJA—”

    “Colonel Favors was in there?” I asked. I was curious why the Staff Judge Advocate, a senior lawyer, for the entire Third Marine Division, would need to be in there to talk to three anthrax refusers. Justin nodded and went on. “—the regimental or battalion surgeon, and maybe one other CO, either Battalion or Company CO.” He finished and let that sink in.

    “Okay, you got me, I give up, why the fuck was the CG, Third MarDiv talking to one of your anthrax refusers?”

    “Get this, they all were sitting out in the hall or waiting area and they get called in and have a talking to from the CG about why this vaccine is completely safe, and why won’t they take this? and all this dis-information out there on the internet is just hype and conspiracy theorists and, now for the money ball, if they’ll just take this shot, all will be forgiven. No court-martial; no NJP; nothing. The whole unfortunate incident will be put behind them.” Justin had a deep, gravelly voice and everything he said tended to come out flat and monotone. A long time of hanging around him had taught me the subtle nuances of that monotone. I saw where he was heading.

    “And no one ever called you, their lawyer?” He shook his head slowly from side-to-side. I whistled slowly and rocked back in my chair. “They’ve got charges preferred already, right?”

    Justin nodded.

    “Yep.”

    There were several troubling things about that scenario from a defense counsel’s perspective. First, Commanders of units are the persons who actually create the courts in the military. They have incredible discretion to either prefer (bring) charges against a member of their unit or not, based on how they see the particular offense, after an appropriate investigation has been done. Convening Authorities also grant search warrants, select the jury pool, can grant clemency after a court-martial and lessen the sentence a judge or jury awards, although they cannot increase the punishment. As a result, charges and dispositions can vary widely from unit to unit, depending upon how serious the particular commander views the offense. Prosecutors (known as ‘trial counsel in the military) and staff judge advocates provide advice to commanders and tend to buffer some of the differences out, but there can still be wide divergence on particular charges.

    That all said, Commanders generally stay out of the process once charges have preferred in order to avoid the appearance of impropriety and subject themselves to an unlawful command influence motion or make themselves into witnesses at a motions session. There are also, for all lawyers, some fairly strict rules of professional conduct for dealing with persons who are already represented. The general practice is generally do not talk to a criminal defendant who is already represented without consulting his attorney first. It just invites trouble.

    I was a bit shocked to hear that the SJA for the Division was present while the General talked to a criminal defendant about the charges he was currently pending, without even notifying his attorney. Furthermore, the charges in the anthrax refusal cases were not even convened by a General court-martial – that is, a court created by a General officer – but instead they were brought at a Special court-martial, a lower forum convened by the Battalion commander, where the accused could receive no more than 6 months confinement, forfeiture of 2/3 pay per month for 6 months, reduction to the lowest enlisted paygrade, and a bad conduct discharge. A General Court-Martial could award any punishment authorized for the particular offense, up to and including death. Refusing a direct order or a general order would have carried ‘a nickel’ for our guys – 5 years – but the statutory cap for all special courts-martial limited their exposure.

    “And get this,” Justin went on, “I heard from my sources that the CG was basically asking them ‘why don’t they trust him’ and shit like that. One of my guys is a Sergeant and finally caved in, crying or very upset, after this long heart-to-heart, and finally agreed to take the shot, so the surgeon took him right then, on-the-spot, to medical.” Now Justin’s voice had a real edge to it. “Do you believe that?!”

    “Curiouser and curiouser,” I answered. Justin looked at me and then caught on.

    “Alice in Wonderland?” he mouthed. I nodded.

    My mind was trying to process what it meant, but more importantly, I was trying to find an angle that would help Justin’s clients. Or mine. I was stumped. I genuinely enjoyed these sessions we had in defense, frequently bouncing ideas off of one another to help focus our thinking, as long as we didn’t have conflicting cases. Justin’s thought process, I found, frequently mirrored my own.

    “Let’s ask Hites,” I said finally. Although I had over eight years on active duty, I was as new as Justin as a lawyer, and I couldn’t think of a rule or regulation that had technically been violated, so it was time to ask someone with more experience.

    Major John Hitesman graduated from the Norwich Military Academy a year before I graduated from Boston University. Like me, Hitesman had a “life” before becoming a lawyer. He had been a “grunt,” an infantry officer, stationed in Hawaii before getting picked up for the Funded Law Program, as I had. Okinawa was his first tour as a lawyer, but he had been a defense attorney there for two years. He had a phlegmatic personality, utterly unflappable in every experience I had with him. He was also one smart cookie and he and I had become friends of a sort, especially after we talked and I found out he played ice hockey at Norwich; he also had discovered a local pickup league in Naha and got me on the team. Given that we were peers, more or less, even though he had pinned on Major already and was now a field grade officer, we would alternate driving to play ice hockey together every Thursday night. I enjoyed the conversation on the rides with him almost as much as playing ice hockey. At six-foot-two, two-hundred and fifteen or so pounds, Hites also looked like a linebacker, but was an agile skater and good stick-handler. At five-six (on a tall day), I was shorter than most of the Okinawans we played against and I always appreciated playing on a line with some ‘beef.’

    When I brought John back into the office, he looked at Justin.

    “What’s going on?  Barney told me your clients got pistol whipped this weekend.” John was one of the few people who addressed me by my call sign from when I was a pilot. When I had first moved into the office next to his, I put up my framed print of an AH-1W attack helicopter my squadronmates had signed for me as a going away present. On the plate it had my name, call-sign, and a quote: “Shakespeare was Right.” Either the prosecutors or the clerks later put a picture on my office door at Camp Hansen of Fred Flintstone and Barney Rubble, with “Hitesman” and an arrow pointing to Fred and “Saran” with an arrow pointing to Barney. I thought it was funny and left it up.

    “Sir, I don’t know if Captain Saran told you, but something weird happened this weekend with my clients and I’m not sure what to do about it.” Justin related the story quickly and Hites listened with his hands laced in front of his face, holding the styrofoam cup that he occasionally used to spit some tobacco juice into from the wad occupying the left side of his mouth.

    “Well, I’ll play devil’s advocate, here. Why can’t a CO call in one of his Marines and talk to him? What’s wrong with that?” Justin seemed a little put off by the question. I was, too.

    “I’m not sure,” he began, then held up his hands, “…that’s why I asked.”

    “I can think of a few,” I piped up. “He’s already represented, there are charges pending, the CG is the convening authority’s direct superior, and it all-around stinks.” Hites gave me a quick glance.

    “I might agree, but what kind of relief are you going to get? I mean, how do you frame this in a motion and what do you think one of our judges is going to say? What would you ask for?” Hitesman’s pragmatism stung me into silence. He was right. There was a long pause. He spit again, then went on.

    “I suppose you could write a letter to the SJA’s state bar because I think there may be an ethical problem that she should know about with her being in there and allowing the CA to question your clients. But then again, the JAG Instruction is only for attorneys, not Commanders, and same for the rules of professional conduct. Why couldn’t a Commander have his attorney in there as a witness? Did she ask any questions of your clients?” Hites now directed a question at Justin.

    “No, sir, I don’t think so. I think she was just in there.” Justin looked at the rug. I was still mulling over John’s point. Something about it didn’t smell right, particularly given the fact that Sergeant Terveen, one of Justin’s clients, had changed his mind about the shot under what seemed like pretty coercive conditions. The Sergeant had less than a year before he was getting out and likely decided that the hassle, and risk of losing his veteran’s benefits, probably wasn’t worth it. The other two, a Lance Corporal and a Private First Class, had stuck to their guns. That was probably more impressive than anything else about the story.

    “The only other issue is whether or not they were warned of their rights.” Hites looked at Justin who shrugged his shoulders. “If they weren’t warned, none of their statements are coming in at court, but the prosecution probably won’t use them anyway and doesn’t really need them. I’m sure they can prove your guys were given the order and didn’t take the shot, and they don’t need any subsequent statements your guys might have made in this meeting. Arguably, they knowingly violated his rights if they didn’t read him his rights and that’s an offense under the UCMJ, but that’s a stretch.” Hites waited a minute and then took a step toward the door.

    “It’s just so fucked up, though,” I said. “I mean, how coercive an environment is that? The CG himself is there telling you that everyone else is full of shit, along with the Sergeant Major, the CO, the Doc. And then the guy caves and he’s immediately given the shot while he’s still in frigging tears! That just can’t be right.” I wasn’t sure where I was going, but it all felt wrong to me.

    “It sucks, gents, but welcome to criminal defense in the USMC on the island of Okinawa.” Hitesman slapped me on the shoulder as he went by. “See ya’ Thursday, Barn. You driving this time?” I nodded a couple of times in response and murmured “mmhmm.”

    Justin looked at me after John was gone. He let out a long breath.

    “God, I just love the Marine Corps!” he said in a drill instructor voice. I hated that I didn’t have any answers.

    “Well, how’s Petty Officer Ponder’s case going?” Justin finally asked. “Did his CO ask him to come in and have a chat?” I chuckled slightly at that. But an idea had come to me.

    “Hey, you know what? I’ve got a bunch of anthrax info from Sonnie Bates’s attorney that I’m supposed to look through. Why don’t you have one of your guys submit an Individual Military Counsel request for me? Then, we can put our heads together on one case and then use what we do on that one for our other two separate cases?” Justin nodded.

    “Sure. Would likely save us time individually and let us pool our efforts. Is any of the information helpful?”

    “Yeah, I mean, it looks… thorough, but I’m not going to get my hopes up yet. I have to research what an ‘investigational drug’ is and really dig in on the statute, but it worked for Sonnie Bates, so… I don’t know, maybe it’ll work for our guys.”

    “Sure it will,” Justin deadpanned. This time I couldn’t tell if he was being sarcastic or earnest.

     

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  • Chapter 2 – The Nuremberg Code

    Members of the military are not shorn of their constitutional rights while they remain in the military service. Blackstone said: ‘. . . he puts not off the citizen when he enters the camp; but it is because he is a citizen, and would wish to continue so, that he makes himself for a while a soldier.’[i]

    After the Germans were defeated in World War II, it was not long before both an International War Crimes Tribunal was created, and a separate Military Tribunal, to try members of the German High Command and others for their “War Crimes, Crimes Against Peace and Against Humanity.”[ii] These military tribunals were held under the auspices of the four individual Zone Commanders, into which Germany had been divided at the end of the war. The Chief Prosecutor for the military tribunals in the American Zone was General Telford Taylor, U.S. Army. There were twelve separate trials held at Nuremberg by the American Military Governor, promulgated by Military Government Ordinance Number Seven, dated 25 October 1946. This ordinance was passed pursuant to the authority granted by Control Council Law Number 10, which set forth exactly who and what could be prosecuted and how the process was to occur (including that someone sentenced to death would be executed no later than 30 days after the “decision has become final”).[iii] It was in the American occupation zone that the second “series” of trials occurred in 1947 against the doctors who performed medical experiments on Jews, Poles, and other persons who were being held prisoner. These trials came to be known as the “Doctors Trials” or the “Medical Trials”. German scientists, some of them renowned in their fields, were tried as war criminals because of the experiments they had performed on behalf of the German High Command on unwilling victims.

    Some of the experiments named in the indictment against the German doctors were startlingly similar to those detailed previously in Chapter 1. For example, Count II of the indictment, entitled War Crimes, [specification] Number 6 alleges that

    Between September 1939 and April 1945 all of the defendants herein unlawfully, willfully, and knowingly committed war crimes, as defined by Article II of Control Council Law No. 10, in that they were principals in, accessories to, ordered, abetted, took a consenting part in, and were connected with plans and enterprises involving medical experiments without the subjects’ consent, upon civilians and members of the armed forces of nations then at war with the German Reich and who were in the custody of the German Reich in exercise of belligerent control.[iv]

    The indictment goes on to list a number of different experiments, the most similar to American experiments of which were the lost (mustard) gas experiments. These were “[c]onducted at Sachsenhausen, Natzweiler, and other concentration camps for the benefit of the German Armed Forces to investigate the most effective treatment of wounds caused by Lost gas. Lost is a poison gas which is commonly known as mustard gas.”[v] One of the most horrifying aspects of the experiments was the scientific precision, and simultaneously the complete disregard for the subjects’ humanity, with which they were carried out – as if they were being conducted on mice. Many of the experiments had obvious utility for all Armed Forces. The U.S. prosecutor acknowledged as much in his opening statement.

    A sort of rough pattern is apparent on the face of the indictment. Experiments concerning high altitude, the effect of cold, and the potability of processed sea water have an obvious relation to aeronautical and naval combat and rescue problems. The mustard gas and phosphorous burn experiments, as well as those relating to the healing value of sulfanilamide for wounds, can be related to air-raid and battlefield medical problems. It is well known that malaria, epidemic jaundice, and typhus were among the principal diseases which had to be combated by the German Armed Forces and by German authorities in occupied territories.

    To some degree, the therapeutic pattern outlined above is undoubtedly a valid one, and explains why the Wehrmacht, and especially the German Air Force, participated in these experiments. Fanatically bent upon conquest, utterly ruthless as to the means or instruments to be used in achieving victory, and callous to the sufferings of people whom they regarded as inferior, the German militarists were willing to gather whatever scientific fruit these experiments might yield.[vi]

    The high altitude tests were done to determine how high pilots would be able to fly; freezing tests on human subjects were done to learn how cold a person could get before dying, as well as what the best ways were to re-heat a freezing person. This had important implications for the Germans fighting on the brutally cold Russian front. Of more specific import for the anthrax vaccine herein discussed, the Germans also conducted a number of experiments involving chemical and biological warfare.

    The most basic mustard gas tests involved simply gassing subjects and measuring its effect upon them. The Germans operated with the complete permission and authority of both their government and the society generally; the subjects weren’t even German soldiers, but captured enemy civilians or belligerents, so some of the tests went a step further and wounded some prisoners first to determine the effect the gas would have upon a wound under battlefield conditions. While it is important to state that none of the experiments involving the U.S. Department of Defense (of which we are aware) involved this kind of treatment, the ‘baseline’ experiments conducted by the German doctors were identical to the U.S. Department of Defense’s ‘man break’ tests conducted in the late Forties and Fifties. In fact, the lawyers for several of the Nazi doctors argued at trial that the German experiments were identical to the experiments conducted by the U.S. and Britain using human subjects in the period between World Wars War and Two. Of course, as has already been shown, the U.S. experiments were conducted, in most cases, AFTER the Nuremberg Trials, and in secret, and on U.S. citizens.

                                                                                                                                                                                       

    During their trial, the Nazi doctors offered several legal defenses to their actions, chief among these was that the doctors had not known that anything they were doing was wrongful because the experiments (in some cases) were no different than ones which had been regularly carried out by the Americans and Germans prior to the War. In other words, the argument is essentially a combination of challenging the war crimes tribunal’s charges as ex post facto laws, as well as a challenge to the notion of being on ‘notice’ that one’s actions are prohibited. i.e. The doctors argued that there existed no agreed-upon international common law on the use of human beings as subjects. While the world might say now, after victory, that the German doctors’ actions were wrongful, there was no law in existence prior to their actions to let them know what they were doing was criminal. This is a fundamental tenet of criminal law generally: the necessary existence of some law making the act criminal before it is committed, in order to provide notice to the actor that such acts are forbidden. This isn’t merely a matter of legal theory; while the reasons aren’t given, four of the seven defendants charged with experiments involving lost gas were acquitted.

    Two doctors who worked with the U.S. prosecution team at Nuremberg, Drs. Andrew Ivy and Leo Alexander, were concerned with the defense arguments about there being no previous international statement or standard regarding the treatment of human subjects and their consent in medical experimentation. In April 1947, Dr. Alexander submitted a memorandum to the American Counsel of six points regarding medical experimentation on human subjects. The verdict against the doctors was returned on August 19, 1947. In the verdict, each of the six points was covered and expanded into ten points under a section entitled “Permissible Medical Experiments.” This came to be known as “The Nuremberg Code.” The Nuremberg Code’s first principle was that “the voluntary consent of the human subject is absolutely essential.” The principles of the Nuremberg Code were adopted by the U.S. Department of Defense in 1953 when the Secretaries of the Army, Navy, and Air Force all adopted a memorandum entitled “Use of Human Volunteers in Experimental Research.” The first principle was verbatim from the Nuremberg Code. In 1964, the World Medical Association in its “Helsinki Declaration” adopted the Nuremberg Code. Eventually, these principles were codified in U.S. law as Title 50, section 1520a, but this didn’t happen until 1977, two years after the famous Church Committee hearings on the CIA and DoD experiments herein discussed.

    There is, however, a seminal case from the Supreme Court called The Paquete Habana, which international law professors will say stands for the proposition that international law, in the form of treaties, executive agreements, and international norms and customs, are an essential part of U.S. domestic law.[vii] If that legal proposition is true, then the DoD’s experiments on its own soldiers without their informed consent was pushing up against the propositions that had been adopted in the aftermath of the Nuremberg Trials. It is certainly clear that by 1977, Congress thought something ‘wrongful’ had happened with the CIA’s MKULTRA program. At the opening of the hearings regarding the program, Senator Inouye, presiding, stated that “[i]t is also the purpose of this hearing to address the issues raised by any additional illegal or improper activities that have emerged from the files and to develop remedies to prevent such improper activities from occurring again.”[viii] Notice, however, what is conspicuously absent from that statement: any mention of holding people accountable for those putative violations of the law.

    Admiral Stansfield Turner, director of the CIA, also seemed to believe that something illegal had happened because he conspicuously noted that (a) he was cooperating with the Attorney General, and (b) reminded the committee that MKULTRA did not occur on his watch, but was a program of another director and that the events were some 12-24 years past at the time of the hearings. MKULTRA lasted from 1953 to 1964 and was conducted in concert with the Department of the Army.[ix]

    Interestingly, no one ever stated exactly what law they believed had been broken, nor what the penalty was for this crime. There was not then, and is not now, any federal criminal statute prohibiting a person or agency from conducting experiments on military members or ordinary citizens without their informed consent. Some members of the committees invoked the  then-newly passed that was the product of a 1975 initial inquiry into these matters, but it wasn’t a criminal statute – it simply mandated informed consent with no actual punishment or remedy listed for violations. Chapter 3 delves into judicial remedies  against a government agent or agency conducting such experiments. Technically, an unconsented medical procedure would constitute a battery or an assault consummated by a battery, but there is no federal “battery” statute; criminal law is almost entirely a matter for the states.

    This raises an uncomfortable moral/ethical/legal question: which is worse, the German doctors who operated (they claimed) out of a genuine ignorance that their actions were wrong – and historically speaking they have a fair case for it – or the DoD and its doctors who clearly knew that their actions were wrongful in light of the German doctors’ trials? Someone will undoubtedly want to take me to task for comparing the CIA’s or DoD’s doctors to the Nazi doctors of World War II, however, either the principles of the Nuremberg Code are the standards of the medical profession or they are not – they cannot be called principles if they can be bent to the will of the doctor performing the particular tests, or justified and waived away after-the-fact with vague references to ‘national survival’ because short of the Revolution or the War of 1812, the U.S. has never faced the kind of military pressure against the homeland as Germany did in WW2.

    The first principle enunciated in the Nuremberg Code is that “the informed consent of the subject is absolutely essential.” There is nothing equivocal about that statement. It does not say, for example, that “the informed consent of the subject is somewhat or mostly essential.” Nor does it manifest any limitation to only Nazi doctors or doctors of defeated Axis powers. As one author has noted, “[t]here is no exception for soldiers or for wartime.”[x] Which all goes to this simple point: there is no “greater good” exception or argument against the principle, because that is exactly what the Nazi doctors said they were doing.

    Sidney Gottleib’s statement that it was considered a matter of ‘national survival’ has two dangerous flaws in it, one obvious, the other insidious. The first, obvious flaw is that it is exactly the same argument that the U.S. and other Allied powers forbade as a defense in Control Council Law Number 10. The Wehrmacht doctors certainly performed a number of experiments whose results had only one possible practical application and that was in the war effort in which they were engaged. In fact, the German doctors, involved as their country was in a losing battle against foreign powers with bombs dropping on them daily, probably had a much better claim to Gottleib’s “national survival” argument than the CIA or DoD had in the continental United States post World War II with the U.S. as one of the world’s only two (nuclear) superpowers.

    More insidious, and hidden in Gottleib’s argument, however, is a claim of moral superiority. Gottleib’s argument allows that either he, or someone else on behalf of the state, can take away the subject’s right to decide the most fundamental question of humanity: the right to live. It is an objectification of the person – the person as tool of the State. As was pointed out by Supreme Court Justice William Brennan’s dissent in the Stanley case, quoting a law review article,

    [Human experimentation authorized by the state] dramatizes the notion that the state is free to treat its nationals in the manner it chooses because it perceives itself as the source of all rights, and therefore as beyond the reach of law, rather than regarding rights as inalienable, that is, not subject to arbitrary cancellation by the State.[xi]

    This is more insidious because it sounds academic and benign, perhaps even agreeable, because, after all, doesn’t each of us owe our way of life to the state? This simple, yet bankrupt, logic, and consequent objectification of human beings can easily be turned on particular groups and yields exactly the kind of thinking that helped create the Holocaust in the first instance. I do not want to oversimplify a tragedy on the scale of the Holocaust into one short sentence; it doesn’t do it justice nor does it take into account the myriad other factors in involving anti-Semitism in Europe that help account for what happened in Europe from 1933 to 1945. It is, however, critical to recognize arguments like Gottleib’s “national survival” and follow them to their logical conclusion, otherwise tragedies like the Holocaust get put aside as historical anomalies and when programs like MKULTRA, the Tuskegee experiments, and yes, even the current DoD anthrax program are announced, apologists differentiate them because, clearly, WE are not in any way morally comparable to the (gasp!) Nazi doctors… even when government actors are violating the exact same principle in the same way.

    It may be that our government agents do not use specifically identical means that the Nazi doctors did: that is, brute force at the point of a gun. Instead, however, the CIA doctors in the MKULTRA program and the DoD doctors in the mustard and lewisite gas tests, or the Atomic Energy Commission in its radiation tests on soldiers, used deception or trickery, additionally backed by the very credible threat of future punishment (court-martial), in order to silence those who might bring their actions to light. In normal criminal trials, attempting to hide conduct is frequently admissible as “consciousness of guilt” – that is, evidence that the actor was aware of the wrongfulness of their actions. Worse than Gottleib’s public justification, however, is that in some cases, government actors consciously change history or the law: destroy documents, close test sites, classify evidence they don’t want to become public, and then offer some higher moral calling as justification – the threat of an invisible enemy, international terrorism, the ticking time bomb, etc. The end result is that these excuses either gain public acceptance, or create a sense of public indifference, to the rights of their fellow citizens.

    Lest there be any question about whether this line of reasoning was ever explored by the Army or CIA doctors at the time, internal documents that were accidentally discovered because they were mis-filed and did not get destroyed like the rest of the more direct source documents became public and put a finer point on it. In 1977 hearings in front of the Senate, internal CIA documents revealed that the CIA believed that it must “conceal these activities from the American public in general,” because public knowledge of the “unethical and illicit activities would have serious repercussions in political and diplomatic circles and would be detrimental to the accomplishment of its mission.”[xii]

    In a 1959 Staff Study, the United States Army Intelligence Corps (USAINTC) even more candidly explained its justification for abandoning the principles of the Nuremberg Code.

    It was always a tenet of Army Intelligence that the basic American principle of dignity and welfare of the individual will not be violated . . . In intelligence, the stakes involved and the interests of national security may permit a more tolerant interpretation of moral-ethical values, but not legal limits, through necessity . . . Any claim against the US Government for alleged injury due to EA 1729 [LSD] must be legally shown to have been due to the material. Proper security and appropriate operational techniques can protect the fact of employment of EA 1729.[xiii]

    That is to say, legal liability could be avoided by covering up the LSD experiments. If no one could prove they had been given the drug, no one on the administering side would ever have to pay the consequences for their actions.

    Putting aside the moral reprehensibility of this position, the issue of the legality of the DoD’s tests is beyond cavil: the experiments violated a slew of laws. They certainly violated the spirit and letter of the Nuremberg Code. They violated any number of state criminal battery or assault statutes: an unconsented drug in one’s drink is a battery. By common law, the person administering such a treatment would be criminally liable for whatever happened to the person taking the drug.[1] These batteries would also be actionable in a tort suit for damages were the doctors in private practice. They violated the “common rule” and accepted standards of medical practice. They violated the civil rights of U.S. citizens, yet no one was ever prosecuted for these (and other) acts; no government agent or agency was ever forced to pay a service member a dime by any court for the harms done to them. The explanation as to why is a sobering bit of legal legerdemain.

                                                                                                                                                                                       

    [1] “During the Rockefeller Commission and Church Committee investigations in 1975, the cryptonym [MKULTRA] became publicly known when details of the drug-related death of Dr. Frank Olsen were publicized. In 1953 Dr. Olsen, a civilian employee of the Army at Fort Dietrick, leaped to his death from a hotel room window in New York City about a week after having unwittingly consumed LSD administered to him as an experiment at a meeting of LSD researchers called by CIA.”  Prepared statement of Adm. Stansfield Turner, Director of the CIA, before a Senate Committee, August 3, 1977.

    [i] U.S. v. Manuel, 43 M.J. 282, 286 (C.A.A.F. 1995)(citations omitted).

    [ii] Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10., Nuremberg, October 1946–April 1949. Washington, D.C.: U.S. G.P.O, 1949–1953.

    [iii] Control Council Law No. 10, Dec. 20, 1945.

    [iv] From the indictment, U.S. v . Brandt, et al. (The Medical Case), 2 Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10, (1949).

    [v] Id.

    [vi] U.S. v . Brandt, et al. (The Medical Case), 2 Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10, p. 37 (1949).

    [vii] The Paquete Habana, 175 U.S. 677 (1900).

    [viii] Project MKULTRA:  The CIA’s Program of Research in Behavioral Modification, Hearings Before the Senate Committee on Intelligence and the Subcommittee on Health and Scientific Research of the Committee on Health and Human Resources, p. 2, August 3, 1977.

    [ix] Id. at pp. 9-14.

    [x] G.J. Annas, Changing the Consent Rules for Desert Storm, 326 New Eng. J. Med. 770 (1992).

    [xi] Bassiouni, Baffes, & Evrard, An Appraisal of Human Experimentation in International Law and Practice: The Need for International Regulation of Human Experimentation, 72 J. of Crim. L. & C. 1597, 1607 (1981).

    [xii] S. Rep. No. 94-755, Book I, p. 385 (1976)(quoting CIA Inspector General’s Survey of the Technical Services Division, p. 217 (1957)).

    [xiii] Id., at 416-417 (emphasis added)(quoting USAINTC Staff Study, Material Testing Program EA 1729, p. 26 (Oct. 15, 1959)).

     

     

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  • Chapter 1 – A Brief History, or “I’m from the government and I’m here to experiment on you.”

    I think it speaks to the undercurrent of distrust of the government and the military,” said Lt. Gen. Ronald R. Blanck, the Surgeon General of the Army, the service that oversees the [anthrax] vaccination program.  “Agent Orange. Nuclear tests in the ’50s. People say, ‘How can you say this is safe?’  Clearly, we have a credibility problem.”

    ~ Steven Lee Myers, Armed Services Opt to Discharge Those Who Refuse Vaccine, N.Y. Times, March 11, 1999.

    The United States Armed Forces has a long and not-so illustrious history of testing nuclear, biological, and chemical weapons… on its own citizens. From at least the 1940’s on (and if you want to include Native Americans, we can go back a lot further!), the Department of Defense has conducted experiments on U.S. servicemembers using ‘unconventional’ weapons. A report prepared by the staff of the Senate Committee on Veteran’s Affairs in 1994 concluded that “[f]or at least 50 years, [the] DOD has intentionally exposed military personnel to potentially dangerous substances, often in secret[.]”[i] That report followed a Government Accounting Office inquiry into experiments conducted on servicemembers by the Department of Defense.[ii] The GAO report detailed many different programs, some of which the DoD still lists as classified, in which servicemembers were given experimental drugs and other treatments without their knowledge or consent. A few of the more stunning examples of experimentation are worth discussing in detail, not simply to attack the Department of Defense or the military establishment, but rather as context because it is against this history that the DoD’s anthrax program was launched. And it is against this background of secret experimentation and tests conducted on coerced subjects that the DoD asks members of the Armed Services to “trust us” with regards to vaccines and inoculations claimed to be safe and effective.

                                                                                                                                                                                                   

    [i] An Institute of Medicine report looking at the history of mustard and lewisite gas found the Armed Forces researching chemical warfare after World War I and up through World War II.  The report even traces some research back before the Civil War.  See Senate Report No. 103-97, at 15 (1994).

    [ii] The Government Accounting Office (GAO) is the watchdog arm of Congress that investigates government agencies.  See “Human Experimentation, An Overview on Cold War Era Programs,” U.S. General Accounting Office, September 28, 1994, GAO/T-NSIAD-94-266.

                                                                                                                                                                                                               

    In the 1940’s, the Department of the Navy began soliciting volunteers to participate in a program to test protective clothing. In reality, the program was designed to test mustard and lewisite gases, chemical agents that the United States thought might be used by the desperate Axis powers at the end of World War II. There are some who claim that the tests were done simply to see what effect mustard gas had on soldiers in order to determine the offensive potential of chemical weapons. The truth is likely that these are not exclusive propositions. Either way, the program solicited potential ‘volunteers’ with the promise of two weeks of extra leave or some other similar incentive. “Due to the strategic importance of these experiments [however], the Navy deemed it inappropriate to inform potential volunteers as to the precise nature of the tests.  Instead . . . the . . . volunteers were led to believe that they would be testing uniforms for use in tropical climates.”[iii]  These ‘volunteers’ were sworn to secrecy and threatened with court-martial if they told anyone about the program for which they had just ‘volunteered.’  Of course, at this point, because no one had told them exactly what they volunteered for, it was relatively easy to extract such a promise. It is rather doubtful that most members would have agreed had they known that they were about to be experimented upon with chemical weapons.

    Nathan Schnurman was a young sailor who figured he could use the extra few days off. He had just finished boot camp and was stationed at Bainbridge, Maryland, awaiting further orders when he volunteered for the program. He was put on a bus for Anacostia, Maryland, where the experiments actually took place. Young Nathan Schnurman, along with the other volunteers, was given a bunk in a Quonset hut and some blankets for that evening. All of the volunteers were issued protective clothing, including a gas mask, given a physical, and the next morning the experiments began. The protective clothing and masks were fitted and checked and then the ten volunteers were led to the testing building. At this point, the volunteers had still only been told that they were testing clothing for tropical weather.

    The building itself was a simple structure with an entrance platform and test chamber. A single door separated the platform from the chamber and an intercom allowed for communication between the subjects inside the chamber and the corpsmen on the platform. The subjects were told that, once inside, a vapor was to be introduced into the chamber and that they were to remain in the chamber for one hour. The subjects were not told what the vapor was, but were told that it might produce a slight irritation on the subjects’ skin, similar to a sunburn. The subjects were admonished not to discuss the experiment with anyone.[iv]

    The volunteers were exposed to the vapor for the one hour, as advertised. After that, they were instructed to continue to wear the protective clothing for another four hours, to eat meals and pass the time in their Quonset hut. They later disrobed and were given physical exams to check primarily for burns on the skin. This routine repeated itself the next day. The second day’s physical was the last one that any volunteer ever received as a part of the experiment.

    The hour-long gas exposures continued on a daily basis for the next four days without incident, save the departure of a few of the subjects due to painful burns. On one of those days, just prior to the morning’s exposure, plaintiff [Schnurman] was informed by a corpsman that they would be testing mustard and lewisite gas that day.

    On the sixth test day, while inside the chambers, plaintiff’s gas mask malfunctioned and plaintiff breathed the noxious vapor being tested. The inhalation of the gas produced extreme nausea and a burning in his eyes, nose and throat. Before being helped out of the chamber, plaintiff regurgitated in his mask. Once outside the chambers and free of his mask, plaintiff continued to experience nausea and dizziness, plus an intense pain in his chest. After further vomiting, plaintiff lost consciousness. No record was made of this incident.

    Upon regaining consciousness, plaintiff was informed that he would no longer be needed for the experiment and that he could return to Bainbridge. He was not given any physical examination or treatment with the exception of local treatment for the minor burns on his skin. Plaintiff left the site of the experiment and traveled to his home in Roanoke, Virginia for a ten-day leave.[v]

    Mr. Schnurman went on with his life, experiencing long-term health problems. Sworn to secrecy, Schnurman felt that he could not tell his personal physician about the source of his ailments because of his oath and the threat of punishment. Thus, he did not provide essential information to his doctors about his health because of his fears of what would happen to him if he told. This scenario was not uncommon.

    A Mr. John T. Harrison described to a senate committee how he was sworn to secrecy in 1943 when mustard gas tests were conducted on him.[vi] Because of these vows to which the man had been sworn, it was not until much later in life that plaintiffs, such as Mr. Schnurman, (1) learned of what had been used on them, and (b) then filed lawsuits against the government.

    A very similar incident happened to a John William Allen in 1945, according to a statement before the Senate Committee on Veterans’ Affairs. Mr. Allen testified that the real purpose of the testing was to determine how much sulfur mustard a man could take before being overcome: these were known as ‘man-break tests.’  “He was exposed several times to sulfur mustard and was removed from further exposure on May 5, 1945, when he passed out in the gas chamber. A physical examination on May 14, 1945, revealed many wounds as the result of exposure to mustard gas.”[vii]

    It is important to understand that these are not isolated incidents.  An Institute of Medicine report in 1993 estimated that some 60,000 military members were used as human subjects in the 1940’s to test just for two particular chemical agents, mustard gas and lewisite, and the majority of these people were not informed about the nature of the experiments, nor were they given proper medical care or follow up after the research.[viii]

                                                                                                                                                                                                               

    [iii] Few things have amazed me more in my time in service than what members of the Armed Forces – even moreso Marines – will do for just a few extra days of leave or liberty. I am still not sure what that says about the military, but leave and liberty are the promise land to most servicemembers.

    [iv] Schnurman v. United States, 490 F. Supp. 429, 430 (E. D. Va. 1980).

    [v] Schnurman, at 431.

    [vi] Is Military Research Hazardous to Veterans’ Health? Lessons from World War II, the Persian Gulf War, and Today, Senate Committee on Veterans’ Affairs, 103rd Cong. May 6, 1994.

    [vii] S. Rep. 103-97, at 18 (1994).

    [viii] Veterans at Risk: The Health Effects of Mustard Gas and Lewisite, Pechura, C.M. & Rall, D.P. (Eds.) Institute of Medicine, National Academy Press, Washington, DC, 1993, p. 3-4, 6-8, 50-52, 224-226.

                                                                                                                                                                                                               

    During the 1950’s and 60’s, the CIA and the Army engaged in experimentation on U.S. servicemembers, both with and without their knowledge. In several different experiments, the DoD caused servicemembers to unknowingly ingest hallucinogens. Most of the experiments centered around ‘mind control’ and interrogation of persons under the effects of hallucinogens. This was prompted by the perception in U.S. intelligence that China and the Soviet Union had used, and were using, hallucinogens for ‘brainwashing’ and interrogation of prisoners of war. This program was known by the code name MKULTRA. It involved giving LSD and another substance known as quinuclidinyl benzilate, a hallucinogen code-named BZ, to unsuspecting members of both the Armed Forces and civilian communities.

    In 1958, Master Sergeant James Stanley responded to a posting on Fort Knox, Kentucky, that solicited volunteers to help the Army develop methods for testing and defending against chemical weapons. Ironically, the volunteers were told they would be testing protective clothing (just as in World War II). MSgt Stanley was transferred to Aberdeen, Maryland, for the testing. He did not learn until seventeen years later that he had been unknowingly given LSD during the program. He found this out accidentally in 1975 when contacted by Walter Reed Army Medical Center, which was conducting follow-up on those who had participated in the 1958 test. Walter Reed wanted to know of any long-term health consequences to MSgt Stanley from his ingestion of the hallucinogen. MSgt Stanley in the intervening years had suffered health problems and hallucinations that he had no explanation for that eventually led to a divorce. See United States v. Stanley, 483 U.S. 669 (1987).

    In another instance, Lloyd Gamble, who enlisted in the U.S. Air Force in 1950, volunteered for a special program to (yet again!) test new military protective clothing in 1957.

    He was offered various incentives to participate in the program, including a liberal leave policy, family visitations, and superior living and recreational facilities. However, the greatest incentive to Mr. Gamble was the official recognition he would receive as a career-oriented noncommissioned officer, through letters of commendation and certification of participation in the program. During the 3 weeks of testing new clothing, he was given two or three water-size glasses of a liquid containing LSD to drink. Thereafter, Mr. Gamble developed erratic behavior and even attempted suicide. He did not learn that he had received LSD as a human subject until 18 years later, as a result of congressional hearings in 1975.  Even then, the Department of the Army initially denied that he had participated in the experiments, although an official DOD publicity photograph showed him as one of the valiant servicemen volunteering for “a program that was in the highest national security interest.”[ix]

    What is worth noting about these programs, beyond the experimentation on servicemembers without their informed consent, are the arguments offered by the proponents and defenders of these programs. According to Sidney Gottlieb, a doctor and former CIA officer, MKULTRA was established to investigate whether and how an individual’s behavior could be modified by covert means. Dr. Gottlieb testified before Congress that “it was felt to be mandatory and of the utmost urgency for our intelligence organization to establish what was possible in this field on a high priority basis.”[x] Although many human subjects were not informed or protected, Dr. Gottlieb’s defended these actions by stating, “. . . harsh as it may seem in retrospect, it was felt that in an issue where national survival might be concerned, such a procedure and such a risk was a reasonable one to take.”[xi]

    These attitudes persist even today. Dr. Gottleib’s responses in the 1970’s sound remarkably like the reasons offered to justify mandatory vaccination of troops today with unapproved, unlicensed, or investigational drugs. In a television appearance in 1997, Secretary of Defense Cohen held up a five-pound bag of sugar and stated that if the bag were filled with anthrax spores, it could wipe out half of the population of Washington, D.C.[xii] In a later opinion editorial appearing in Army Times, Secretary Cohen wrote that

    At least 25 countries, including Iraq and North Korea, now have – or are in the process of acquiring and developing – weapons of mass destruction . . . This is not hyperbole. It is reality . . . The race is on between our preparations and those of our adversaries. We are preparing for the possibility of a chemical or biological attack on American soil because we must. There is not a moment to lose.[xiii]

    The truth of these matters will be examined in greater detail later. The point to be made here is that Secretary Cohen’s defense of the anthrax program, and the justification for biological warfare programs generally, distilled to its essence, is nothing more than “the ends justifies the means.” Where matters of national security (Gottleib called it “national survival”) are at stake, it does not matter how we go about defending ourselves, even if it means experimenting on unsuspecting troops, because it involves ‘National Security’.

    This is a particularly dangerous path for a number of reasons, some obvious and others not as obvious. While there are any number of moral points of view about using troops in this way, one’s opinion about whether it is right or wrong to experiment on troops in this fashion depends largely on one’s view of individual liberty for the citizen-soldier and the limits of a nation state’s ability to protect ‘itself.’ These arguments inevitably devolve into philosophical debates, punctuated by twelve-letter words and citations to long-dead philosophers, spoken by people far removed from the gas chambers and vomiting victims on their hands and knees; much like Dr. Gottleib’s testimony in an air-conditioned chamber in front of politicians and cameras during the famous Church Committee hearings. More importantly, where ‘military’ or ‘national security’ matters are concerned, the academics inevitably defer to those wearing uniforms with stars on their collars.

    It would appear on the surface that this issue was decisively concluded at the end of World War II in favor of the rights of the individual. In August 1947, the Nuremberg Trials of the Nazi Doctors, including those such as Karl Brandt, came to a close, resulting in the death penalty for many of the doctors who conducted such experiments on unwilling prisoners in concentration camps across Hitler’s Reich. It is there that we must turn briefly in order to understand the law of informed consent and how it applies to the military, if at all. But if it seems that the present author is ‘laying it on a little thick,’ compare Secretary Cohen’s above remark about the necessity of the mandatory anthrax vaccine program to this one:

    We are not conducting these experiments, as a matter of fact, for the sake of some fixed scientific idea, but to be of practical help to the armed forces and beyond that to the . . . people in a possible emergency.

    This is from a letter written by Doctor Wolfram Sievers, Colonel in the German Army in November, 1942, to Dr. Karl Brandt, both convicted Nazi War Criminals, excerpted from Prosecution Exhibit No. 263 at their trial.

                                                                                                                                                                                                               

    [ix] Id., notes omitted.

    [x] Human Drug Testing by the CIA, 1977: Hearings Before the Subcommittee on Health and Scientific Research, Committee on Human Resources, U.S. Senate, September 20-21, p. 169 (1977).

    [xi] Id., pp. 169-217.

    [xii] Paul Richter, Experts Assess Risk of ‘New Terrorism’ Threat, Los Angeles Times, Feb. 7, 2000.

    [xiii] William S. Cohen, Preparing for a Grave New World, Washington Post, Jul. 26, 1999.

     

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  • The Untold Story of the DoD’s Anthrax Vaccine Program, Serialized: Prologue

    “This court will come to order in the case of United States versus Petty Officer David M. Ponder, United States Navy, at Marine Corps Base Camp Foster, Okinawa, Japan.” I’m a little nervous, like I am at the beginning of every trial, but I don’t show it. It’s just an arraignment anyway. We’re mostly here to arrange dates for trial and I’ve already talked to the prosecutor, known as the “trial counsel” in military parlance, a professional Marine Captain by the name of Chris Kolomjec, and we’ve agreed to push the dates out a bit on this case. Like me, he had another specialty in the Marine Corps before becoming an attorney, so we have a collegial relationship. Chris is going on temporary duty to an exercise in Thailand called “Cobra Gold” and I’m in the beginning stages of a plan to plead this case out under very favorable terms if I can get in to see the Convening Authority – my client’s Commanding Officer – while he’s out of town. In courts-martial, the prosecution has one-hundred twenty (120) days to be ready to go to trial and the arraignment stops that clock from running.

    In David Ponder’s case, stopping the clock is mutually agreeable, but we have to coordinate our plans with the judge’s trial schedule.
    I put on the required lawyerly mask of indifference, but inside, my guts still twist a little. A trial is like the start of a “big” game in sports, except the stakes are a whole lot higher. I am, as one might expect, extremely competitive, particularly in sports, but I’ve played and lost enough games to have perspective – at the end of a game, even after a loss, nobody goes to jail, gets busted, kicked out of the service, or loses their pay. On the other hand, as a defense counsel I also have a standard line to my clients: “At the end of the day, I’m not the one going to jail. I’m going home to my wife and four daughters.” Notwithstanding this shpiel, I’m a bit new at this and keenly feel the punishment hanging over my clients, the mythical sword of Damocles hanging there, waiting to fall. One mistake on my part…. On the Defense side of the courtroom, it is your intellect, initiative, imagination – and a ball point and legal pad – against the resources of “The United States of America.” While it can be a unique intellectual challenge, it is also daunting because I am gambling with another person’s liberty. Anyone who ignores that is either another class of lawyer than I am or a fool.

    I edge a little closer to Petty Officer Third Class Ponder, a sailor who refused the controversial anthrax vaccine. My move closer might appear to outsiders as a sign of my solidarity with my client; and in David’s case, it’s got some truth. We’ve only just met, but I like him. In most cases, however, being proximate to my client makes me feel less alone. I am six months removed from Naval Justice School, nine months from passing the Bar, eleven months from law school graduation, and a lifetime away from my former occupation in the Marine Corps as a Cobra attack helicopter pilot.

    Captain Kolomjec finishes reciting his bona fides and how the court came to be created by the Commanding Officer of Naval Mobile Constriction Battalion Seventy-Four, Petty Officer Ponder’s C.O. This part really was boring, scripted, and I waited for my turn to speak.
    “Captain Saran?” the military judge, Lieutenant Colonel Tim Miller, looked up from his Military Judges’ Benchbook in my direction, my cue to do my part.

    “Sir, I have been detailed to this court-martial by Major J.R. Woodworth, Senior Defense Counsel, Legal Services Support Section, Third Force Service Support Group, Camp Foster, Okinawa, Japan. I am qualified and certified under Article 27(b) and sworn under article 42(a) of the Uniform Code of Military Justice.” I don’t need to look down at my trial guide for this, which is a script for Navy and Marine Corps trial proceedings for the repetitive parts in the process. It keeps everyone tracking where the trial is, but the real reason for it is to make for better records of trial. Anyone who receives a punitive discharge in the military gets an automatic appeal up to their service specific appellate court. Given the number of courts-martial in the military, this helps the appellate courts do their jobs. Arguably, it also helps the accused get a better, cleaner trial. The familiar recitation helps my nerves dissipate; I suspect it has something to do with being raised Catholic.

    “I have not acted in any manner which might tend to disqualify me in this court-martial and no other defense counsel, either military or civilian, have either been detailed to or are on this case.” I start to sit down and then stay on my feet in anticipation of my client standing up when the judge speaks to him for the first time – just as I instructed him to do.

    “Are you Petty Officer Ponder, the accused in this case?” David Ponder stands up to the position of attention.

    “Yes, sir.” Firmly, not too loud, perfect. He looks good in his uniform, as well. I know because I inspected him myself before we came into court. The defense shop keeps an extra set of uniforms, spare ribbons and devices, and whatever else we can scavenge for when our clients are brought in by the chasers – military escorts – from the brig. They come over in those ubiquitous orange jumpsuits in shackles; while their units are supposed to provide the uniforms for them, we always wind up with clients missing ribbons and sundry uniform items, so we have a small stock available.

    “Okay, Petty Officer Ponder, you may take a seat, and you may remain seated unless I otherwise direct you to stand.” Lieutenant Colonel Miller nods gently from behind his glasses. I notice he’s still rubbing his hand as he continues, a habit since the pins were removed. The judge flipped over the handlebars of his bike and busted his wrist up pretty badly and I knew the scar must itch where the pins had come out. Reconstructive shoulder surgery at 15 left me with an intimate understanding of that feeling.

    We finish with the preliminaries; I rattle off all of the awards which David Ponder had earned during his three years as a Navy Seabee. The judge goes through my client’s rights to counsel, military and civilian, and then his own qualifications. He then gives us a chance to challenge him or ask any questions if we think he might be partial for any reason, a formality at this point, because I’m pretty sure that Lieutenant Colonel Miller isn’t even going to hear this case if we go to trial. He’s likely to pass it to Major Eric Stone, the other military judge on Okinawa, because of some scheduling conflicts with other cases in the Pacific region, which includes mainland Japan and Korea. We all do a good bit of traveling because of the odd and disbursed units that have occasional courts-martial, but the bulk of the work is on Okinawa.

    I look over at my client; David Ponder looks young to me – and I just turned thirty. He has the beginnings of a moustache, but it’s just that, the beginnings. The good thing is that he likes to keep his hair short by Navy standards, which helps in a Marine court. He’s also a genuinely squared-away sailor. I liked him, which is supposed to be irrelevant to attorneys, but it’s not. Everyone gets the same level of representation; it’s just a question of whether you like defending them or not and whether or not you’ll feel badly if they’re convicted. It also helps in generating the emotional energy to work late nights and long hours cheerfully, as opposed to drearily.

    “Petty Officer Ponder,” the judge breaks into my thoughts, “I now ask you how do you plead, but before accepting your pleas, I advise you that any motion to dismiss or grant any other relief should be made at this time. Captain Saran?”

    I stand up, my stomach now fully settled, which is great because we’re just about done; we have our dates for trial, but I’m thinking this gets pled to a Summary Court martial, where my client can get no more than 30 days in the brig and no punitive discharge, but he’s probably going to have to waive his right to an Administrative Discharge Board and they’ll kick him out with ‘bad paper’ – an ‘Other Than Honorable’ discharge, which is like being fired from the military.

    “Sir, at this time Petty Officer Ponder requests to defer entry of pleas and motions in accordance with the schedule the court has already set forth.”

    The judge goes through the dates Kolomjec and I have already picked for motions, responses, witness requests, and discovery. All parties are agreed.

    “Anything else from either party before we adjourn?”

    “No, sir,” both Kolomjec and I answer after glancing at each other.

    “Then this court is in recess.”

    “All rise!” Kolomjec intones. I’m already on my feet and David joins me as the judge passingly says “Carry on” and departs.

    As my client and I walk out, we almost bump square into David Allen, a reporter from the Pacific “Stars and Stripes.” I’ve only been on the island for a few months, but my reaction is immediate – I step in and tell David Allen we’ll give a statement at some point and he’ll be the first to know. Blah blah blah.

    The first thing any decent defense attorney wants regarding his client’s talking – to anyone, but particularly law enforcement and the press – is to STFU and let the lawyer do the talking. The cop shows and movies are dead-on in one respect: anything you say can and will be used against you. Plus, offhand I can’t remember either the Code of Professional Responsibility or the more stringent Navy Instruction for all Judge Advocates on speaking to the press. I know generally it’s frowned upon, if not outright verboten, to speak to the press. Add to that my natural aversion to the media as a military officer and I’m curt, but polite.

    Oddly enough, this is one of the few times it likely won’t matter. It’s not as if David could say anything damning – he had refused a direct order to take the anthrax vaccine and even talked about it in interviews with local media in his homeport of Biloxi, Mississippi. There isn’t a whole lot of dispute factually. I don’t want to give the government any additional ammunition for sentencing, however, should we ever get there. A jury or military judge would probably not look kindly on someone who was bashing the military in the local paper. So, we pass on the “exclusive.”

    Back in my office, I drop into my chair.

    “Sir,” Petty Officer Ponder begins, “what happens now?”

    “Well, you heard the dates for motions. That’s the next big milestone. It’s likely that the prosecutor will file a motion asking the judge to find the order to take the vaccine lawful. That’s been the standard in the few other anthrax cases that have gone to trial. The good thing is that Captain Kolomjec leaves for Thailand the day that our response is due. Likelihood is he won’t be around in the afternoon when I drop the response off on the prosecution. He also won’t be back until right before the motions session and I’m betting no one else is going to pick up our response and run with the ball. So, it may not win the day, but it will certainly limit his time to be ready to answer our motion.” David Ponder nods, but I can tell he’s nervous. I would be, too, if I were in his shoes.

    “Sir, did you get in touch with Major Bates’s attorney, Mister Smith, at that number I gave you?” David Ponder put me in touch with an attorney in the States named Bruce Smith, an administrative judge in North Carolina and Major in the Air Force Reserve. He defended Air Force Major Sonnie Bates, the highest ranking officer to refuse the anthrax vaccine. He had been discharged with ‘good paper’ as a result of a plea negotiation.

    “Yeah. I talked to him. Interesting conversation.”

    When I spoke to Bruce Smith, he calmly asked me if I could consider that the order to take the anthrax vaccine was unlawful. Not quite expecting the question, I had said, sure, albeit hesitantly. In my own mind, I figured he was a loon, a conspiracy theorist, but he had gotten a good result for Major Bates, so what did I have to lose by listening to the guy? He told me to look up a particular federal statute and then said he would send me some other materials and asked if I would I please keep them “close hold.” His manner was so cordial, I casually agreed, thinking nothing of it.

    My boss, Major John Woodworth, figured he had done me a favor by assigning me – a brand new judge advocate – three of the four anthrax refusal cases on the island of Okinawa. The assumption was that these were guys looking for an excuse to get out of the military and the units would likely agree to Summary Court deals with a Board waiver and these would be over in short order. Like Tom Cruise in a “Few Good Men” I came to David Ponder’s case with the goal to get him the best deal possible, and do it quickly and quietly. I also have several major cases pending, including a rape defense.

    I got the first three of my anthrax shots just before coming to Okinawa. I took them somewhat reluctantly, as I had read an article in a major news magazine about the possibility of some experimental substance called squalene being in the anthrax vaccine given to soldiers during Desert Storm. I had sat in the medical clinic at Naval Justice School in Newport, Rhode Island, discussing the matter with another Marine attorney. Both of us had served previously as officers in the Fleet Marine Force and while we tended to think that squalene had been used in the anthrax vaccine, our leaders wouldn’t allow it to be used now. Quite simply, we trusted our chain of command, our senior officers.

    David breaks into my thoughts.

    “Do you think my CO might consider not court-martialing me or something if you explained this to him?” David Ponder’s question was laden with ethical implications that I was glad I explained to him. While the anthrax vaccine was getting a lot of attention in the press back in the States, and the issue was very interesting legally, I couldn’t let that interfere with my duty to my client, which is to advocate his interests. If he wanted to deal, to plead guilty, no matter how much I might like to litigate the issue, it was his ass on the line. I explained as much to him from the start. David Ponder didn’t have a Juris Doctor, but he was sharp and understood the bottom line.

    “Well, I’m going to set up a meeting while Kolomjec’s away and see if the C.O. won’t listen to what we’ve got to say. I’ll get back to you as soon as I get out of that meeting, okay?” I smiled at him.

    “Okay, sir. I’m going to change up. Where can I go to have a smoke?”

    “Out on the stairs at the end of the building.” I nodded toward the general direction. When he left, I went back to work. I was concerned with the other fifteen other clients who were counting on me to keep them out of jail. At the time, I had no idea that David Ponder’s case would take us both from Okinawa to the highest military court of appeals, to the doorstep of the Supreme Court, and eventually to testifying in front of Congress. It would also eventually cost me my active duty career, but that was a long way off.