Glibertarians.com 2019 Archive

Category: Rule of Law

  • Chapter 19: Working Behind the Scenes

    Executive Order 13139, which implements 10 U.S.C. § 1107, clearly states that the requirements it incorporated from the statute are for internal management only and confer no right enforceable by any party against the United States. E.O. 13139, §6(b).  Additionally, Secretary of the Navy Instruction 6230.4 of 29 April 1998, which implements the Department’s anthrax vaccination implementation program states that the anthrax vaccine is a FDA-licensed product and not an IND requiring informed consent for its administration.[1]

    “Someone from the editorial board will be down to get you and bring you up to the Boardroom in a minute,” the secretary smiled politely and then went back to answering the telephone, no longer concerned with my presence. I looked around the foyer of the Army Times Publishing Company.  It was a large, open-air affair. Just past the circular receptionist’s desk there was a staircase leading to the upper floors. Beyond that the ceiling opened up all the way to the top of the building and I could see people moving on the upper catwalks, worker-bees in the hive. Off to my left was a hallway that disappeared out of view, with an elevator at the beginning where it opened into the foyer.  To the right looked like a glass-enclosed company store with the usual assortment of sweatshirts, tee-shirts, and coffee mugs with the company logo on them. Army Times published a newspaper dedicated to each service, with the imprint Marine Corps Times, Navy Times, etc. The papers were widely read and respected in each service. I didn’t know how it had happened, but my friends had gotten us a meeting with the Editorial Board of the parent company.

    The door behind me came open and I could feel the cold December air blow in. I played with the zipper on my flight jacket, trying not to fidget. A Marine officer in uniform should not appear nervous. An older gentleman walking by with a long-sleeve tee-shirt with the company logo smiled at me.

    “How are you today, Captain?” He was looking at the leather patch with the wings on it on the front of my jacket.

    “Fine, sir. Thank you.” I flipped my fore and aft cap around in my hand and then looked at my watch. I was forty-five minutes late but the receptionist told me when I asked that the meeting had gotten a late start. I hoped my part hadn’t come up yet. I started thinking that maybe I should have brought my briefcase in with me. Right then a young black woman appeared from the stairs and looked at me for confirmation.

    “Captain Saran?” I nodded. “Come with me, please.”

    “Thank you,” I responded and followed her up the stairs. As we turned for the second flight I saw a familiar face. Colonel John Richardson, United States Air Force Reserve, was coming down the stairs in a light blue power-suit. He smiled and stuck out his hand.

    “Great to see you, Dale, traffic was terrible, huh?” We shook hands as he reached my step.

    “Meh, just sick as a dog. I would have stayed home had my boss not made me go in this morning.” I tried not to whine but I felt like crap. My wife and four girls were all sick at home with some kind of stomach virus that had everyone throwing up, including me. I had gotten back from the hospital with my wife the night before at 2:00 am and I still felt weak and achy.

    “Well, go on up,” he said. “Lou is on right now, then Russ, then you. Are you sure you’re still okay doing this? You know you don’t have to?”

    “No, JR, I’m fine. I just don’t care anymore. Lou and I talked about my status and the relevant instructions. This is a freely made decision. Sometimes a man’s gotta stand up and be counted.” Though he was quite senior to me, I had come to know and think of him by his nickname from our many e-mail chats.

    “Okay,” he nodded reassuringly. “I’ll be up in a minute.” JR turned and continued down the stairs.

    “Great,” I answered with more enthusiasm then my body had in it.

    It wasn’t bravado, nor some inflated sense of honor; I felt comfortable talking to John Richardson about such matters as personal honor and integrity. All of the members of our small band had incurred significant professional risks and opprobrium already in order to bring the flaws and illegality of the anthrax program to light. I couldn’t very well be a part of their group and not be willing to stick out my neck. They had all done a lot more.

    My guide and I reached the top of the stairs, turned left, and I could see a set of large oak wooden doors. As we got closer, I could see a little placard that read “Main Boardroom.”

    “Here you are,” the young lady said and turned away as I reached for the door. I could hear voices. I wanted to make as unobtrusive an entrance as possible so I turned the doorknob slowly and tried to slip in.

    I took in the room with a glance. There were two groups of people – ours and theirs. About seven or eight reporters and editors on the far side of a long meeting table, none of whom I knew or recognized. Everyone had a placard identifying them, but I didn’t have time to read each one. Behind “them” was a bright light with an umbrella behind it and a photographer taking pictures. On “our” side of the table there were five men, three I knew, two I guessed at their identities by our email correspondence. ‘Lou’ Michels – actually J.J. Michels, Lieutenant Colonel, USAFR, attorney-at-law, as well as partner at McGuire, Battle, and Woods, whom I had met at David Ponder’s Congressional testimony – was speaking intently.

    “Hey, Dale! Come on in,” he waved me in without breaking stride. “Hey, Lou” I replied and started to take off my coat, heading for the seat on his left, farthest from the door.  “So again,” he went on, “the informed consent issue is completely separate from the issue about whether or not the vaccine is safe and effective.” As I reached the seat beside him and slid into it, I could feel people on the other side of the table watching me. The photographer started snapping pictures of me.

    I am not impressive in uniform, but I had a few “been there” ribbons from when the squadron I was with rescued Air Force Captain Scott O’Grady from inside Bosnia-Herzegovinia in 1995. Atop the few ribbons I had was a set of gold Naval Aviator’s wings. I could tell the reporters on the other side of the table were curious about where I fit into all of this. Not wanting to appear self-conscious, I swiveled my chair to face Lou as he spoke. I could hear the shutter of the camera clicking. I could only imagine what my boss was going to think if a color photo of me showed up in the next issue of Marine Corps Times. I began to wonder if I should have agreed to do this after all. I was just snapping into my new job as a prosecutor and here I was (still) playing defense attorney – to the media, no less, against the entire U.S. military.

    I listened attentively, even though I had heard Lou make this argument before Congress and I had made a more detailed version of the same one to a judge on several occasions myself. Lou Michels is a seasoned attorney at a prestigious law firm and a former active duty Air Force officer. He is articulate and confident when he speaks, particularly on the legality of the anthrax vaccine. Although I was a Captain and he was a Lieutenant Colonel in the Reserves, I had come to think of Lou, and all the members of our group as a kind of Robin Hood and His Merry Men-like affair. There was JR who was the most senior of all, a full bird Colonel; Tom “Buzz” Rempfer, a Major, Air Force Academy graduate, F-16 and A-10 pilot; Russ Dingle, also a Major and A-10 pilot, and Redmond Handy, another Colonel. Despite the fact that I was by far the junior member of the group, it all felt quite easy and natural. I was conscious of my place in the hierarchy, but certainly not anything like a chain-of-command. Perhaps it was because more than a few of us were former pilots and pilots have a long history of being somewhat less conscious of rank and more conscious of ability, a byproduct of the nature of aviation.

    “It’s like Rogaine,” Lou continued on, “which has some particular relevance to my own situation,” he added parenthetically, looking upward with his eyes toward his own hairline. I noticed for the first time that he had a small patch of thinning hair on the back of his head. “It was originally licensed by the Food and Drug Administration as a blood pressure medication. Now, during some of the trials they determined that it would grow hair on a billiard ball. Notwithstanding the fact that it was already licensed, they had to go back and get a change in the license because of the change in the purpose for which it was going to be used.” He paused for that to sink in. He looked around the table at each of the editors and reporters, the shutter of the camera clicked away. “That’s the law for getting medications legally approved. It is even more imperative when it involves biologics like vaccines.”

    Lou went on for a while longer, hitting the high points of his brief and then excusing himself. I knew he had another meeting to attend at his law firm. We had talked on the phone the day before and everyone knew what their role was in this presentation.

    Russ Dingle, Major, USAFR, went next. He gave a presentation of how the vaccine was, by the definition in the FDA regulations, an “adulterated product” and thus should not be allowed to be shipped in interstate commerce. I had not heard his presentation and I had not met Russ before, except to exchange a few emails over the previous nine months. His knowledge of the company that makes the anthrax vaccine, BioPort, Inc., was unmatched. The reporters asked questions and Russ always had an answer and could cite to the document from which he got it. I was known among my colleagues for being able to pull legal case cites out of my ass on demand, but Russ made me envious.

    I had read all of the FDA inspection reports, but he obviously had access to information that I had never even guessed at. John Richardson had told me that he and Russ had been going through twenty-six boxes of information that they had gotten access to from the House Committee on Government Reform. Russ appeared to have memorized all twenty-six boxes. When he started describing how BioPort’s predecessor in interest, Michigan Biologic Products Institute had added two fermenters to its production line without FDA approval, then added two more and removed the original fermenter from the production line, I felt like my defense of David Ponder and Jason Stonewall had been inadequate.

    As I listened to Russ detail the failed inspections – the dripping paint into production vats, contaminated product lots containing other medicines like penicillin in them, and a list of other egregious quality control violations – the anger and frustration of nine months of defending David ponder and Jason Stonewall welled-up in me. Even worse, the Navy-Marine Corps Court of Criminal Appeals had denied our writ-appeal of the judge’s ruling on our motions. I had until today to submit an appeal of the NMCCA decision to the highest military appellate court, the Court of Appeals for the Armed Forces, one step below the Supreme Court of the United States. My turn was approaching, so I tried to focus and make sure I maintained the momentum in our joint presentation. I  also knew I had to control my mouth; the Judge Advocate General (JAG) Instruction that controls the conduct of Navy and Marine Corps attorneys had strict limits on what attorneys could say to the press and I still technically had pending cases on this issue.

    As a practical matter, most Judge Advocates (myself included) avoided the press completely and referred any questions to the Public Affairs Office (PAO). I was cognizant of the Code of Professional Responsibility for lawyers that also prohibits using the press to influence the outcome of a court. I had just moved to Quantico, Virginia, and, due to my daughter’s health problems, I was now working as a prosecutor in the Office of the Staff Judge Advocate, Marine Corps Base Quantico, Virginia. I didn’t think my new boss, a long-time Colonel, would be particularly enthused to see my name popping up in the Marine Corps Times bashing the government’s anthrax program.

    An Air Force doctor, Captain John Buck in Biloxi, Mississippi, had requested me to be his Individual Military Counsel (IMC) and that request had been denied by my bosses – they had good legal reasons, but in my heart I had hoped that they would carve an exception and let me do it. It dawned on me that perhaps I had become too personally involved with the anthrax issue and that it might be affecting my judgment as a lawyer, but I had been over that ground both in my own mind and with my clients many times.

    “And that’s the vaccine that the Department of Defense is making your service members take, under threat of imprisonment,” I heard Buzz saying. He and Russ had been thrown out of their Connecticut Guard unit over the Anthrax Vaccine Immunization Program (AVIP). Tom looked nothing like what I had imagined. He was young, lean, and a poster-boy for an Air Force pilot. I had pictured him much older from my conversations on e-mail with him.

    “And now,” he went on, “Captain Dale Saran, U.S. Marine Corps, will brief you on some of the current anthrax cases and their status. Dale,” Tom turned to me and winked.

    “Thanks, Buzz,” I answered and turned to my section in the briefing book that John Richardson and some of the others had put together the previous few days. I looked up at the reporters across from me. I tried to ignore the photographer snapping pictures. I could handle my portion of the brief any number of ways. Cool, dispassionate, the quintessential picture of a lawyer. A bit of an act for me, as I am a much more direct and blunt naturally, but I was trying to gauge my audience. What would be most convincing to a group of reporters? I could be more intense, somewhat exasperated at the situation my clients find themselves in. I decided against that – the last thing I wanted to do was come across as histrionic. I had thought a lot about this moment and had never been able to arrive at a decision. I decided to just start speaking and see where it took me.

    I cannot remember exactly what I said, but at one point I recall answering some questions about the status of our appeal.

    “This is nothing new,” I blurted out. There was silence from the other side of the table. “I invite any of you to look at the history behind the current version of Title Ten, section eleven-oh-seven.” And then I launched into my argument. I could feel myself heating-up as I recounted the use of the investigational and experimental drugs on troops prior to and during the Gulf War. I explained how the Food and Drug Administration had struck a deal with the Department of Defense to grant a waiver to allow these drugs to be used on service members without telling them what was being used on them. I recounted the withdrawal of this waiver and the reports of Gulf War Illness. I spoke forcefully, passionately, without consideration for what the ramifications might be to me. I spoke The Truth as I had come to know it in the past year defending my clients.

    I took a breath and looked around. Tom Rempfer and my cohorts were looking at me, waiting for more. I gathered myself, the calm after the storm.

    “That is exactly why this statute was passed, to prevent these types of things from happening again, to prevent another Gulf War-type Illness.” There were some questions. I answered and eventually Tom or someone else picked up a thread and my turn was done. I had so much more I wanted to say. I wanted them to know The Truth, The Whole Truth, as I had come to know it down to the marrow in my bones.

    I looked at my watch. Shit! I thought. I still had to get to CAAF in downtown D.C. and turn in Petty Officer Ponder’s writ-appeal of the NMCCA decision rejecting our request for extraordinary relief. I had to go.

    I listened for a while and slipped out at an appropriate time, saying my goodbyes by touching each man’s shoulder briefly as I passed on the way out. I was proud to have been invited to be a part of their panel.

    Outside the snow was beginning to fall more heavily. I started our family minivan and quickly got into the flow of traffic inbound on I-395 for the District. I had a writ-appeal to finish typing on my laptop and I didn’t have much time to get it into the Court.  With the NMCCA decision, the stay on our court-martial had been lifted. Although David Ponder had come home to Mississippi and his wife and son, Jason Stonewall and Vitolino Arroyo were still in Okinawa, six months after their unit had left and returned to Camp Lejeune, North Carolina, and all three were facing the brig unless I got a higher court to listen to me and overturn the lower appellate court. I looked at my watch again.  Suddenly that stay – and the nail in Kolomjec’s door on Okinawa – seemed a very hollow victory.

    [1] Ponder v. Stone, 56 M.J. 613 (NMCCA, 2000)

  • Chapter 18: The Walking Wounded

    One year ago today, I was stationed in Dhahran, Saudi Arabia. I received my fourth anthrax vaccine. That’s when my problems began. Until that point, I weighed 175 pounds, 5’9″, excellent physical condition. That night, I had a raging fever and my physical condition continued to deteriorate over the next couple of weeks. During that time, I lost facial hair, my testicles shrank to the size of a peanut – the right one that I could find. I had rapid weight gain, mainly in the form of subcutaneous fat, suffered mood swings, had severe groin pain, and I lost muscular strength. I went from a normal workout bench press of 280 pounds to less than 100, and that was in the space of less than two weeks . . .

    As I got ready to leave Saudi Arabia in May, I visited with a new flight surgeon. He reviewed my records and he noted the strong link between a shot on one day and being ill the next. He also directed that I put in a VAERS report at an Air Force medical company co-located on that same compound. I wrote up the report, I walked over and an Air Force – a senior Air Force doctor came out and blocked the report. He scrawled across the back of the page that he did not think they were related, that I needed to see a urologist, and if the urologist concurred then he’d go ahead and file the report. Had he asked, or had he looked at my records, he’d see that I’d been under medical care, specialist care, for over six months.[i]

    “Sir, they’re saying that they’re not going to let me come there to testify.” David Ponder’s voice echoed over the phone. I waited to answer.

    “Listen, don’t worry. Jen’s calling Beth Clay on the staff of the House Government Reform Committee. I’ll get hold of someone there. Believe me, your command isn’t going to take on a Congressional committee.” David Ponder had been invited to testify before the House Committee on Government Reform. He was calling from Okinawa.

    “I hope not, sir.” Although we had gotten the stay, David was still worried that he would be left in Okinawa. This was because members of his command had told him that he would be left in Okinawa until the stay dissolved and/or the case was resolved, even though his unit was preparing to return from its seven-month deployment in the first week of October 2000.

    Coincidentally, in the first week of October 2000, the House Committee on Government Reform was holding another hearing on the anthrax vaccine program. The Committee had already issued an extraordinarily condemning report in April of 2000, after some eight or nine hearings. Specifically, the report was critical of DoD’s media campaign against members who refused to accept the vaccine and it called for a moratorium on the entire program. In an interesting comment on the state of military-civil affairs, Marine Major General Randall West, a Cobra pilot of some repute and point man for the AVIP, immediately held a press conference rebutting the Committee’s report. It was surprising, and disturbing, to hear a senior military officer criticizing a committee of Congress because of its disagreement with a DoD program.

    “Don’t worry, David. We’ll get you here.” I said it with more conviction than I felt. I was in my house in Quantico, Virginia. I had to leave Okinawa early because of medical needs for one of my daughters. The Marine Corps had been fairly accommodating in sending me to Quantico to be near appropriate medical care, but it meant I had been removed from defense. I was now a prosecutor, while retaining my anthrax cases that were subject to the stay.

    “It’s hard not to, sir.”

    “We’ll get you here.” If David’s command didn’t send him, I wasn’t sure what I would do. David’s wife, Jennifer, was very active in lobbying for David with Congressional members. I hoped she would be able to put some pressure on a representative who would in turn put the heat on David’s command. I was already way over my head. An appellate stay was above my paygrade as a Captain, but General Officers giving press rebuttals to Congressional reports was way, way out of my depth.

                                                                                                                                                                                                               

    When I was detailed David Ponder’s case in Okinawa, my first thought was to deal it out quickly and move on. As I learned more about 10 U.S.C. §1107, I was shocked, but excited, as a defense attorney. I never really focused on, nor was it particularly fruitful for me to argue in court about the safety of the anthrax vaccine. I myself was skeptical of people reporting adverse reactions. Sitting in the Rayburn Building on October 5, 2000, in a chair right behind David Ponder, I had a change of heart. I watched and listened to human tragedies. One woman, the wife of BioPort worker Richard Dunn, explained how her husband died from a systemic reaction to the vaccine.  The coroner for Ionia County, Michigan, announced that Richard Dunn had inflammation throughout his body as a reaction to the vaccine. Mr. Dunn had taken his eleventh shot of the anthrax vaccine in May. He died on July 13, 2000. Richard Dunn was required to take the same shots as service members, as well as annual boosters, because he cared for some of the animals at BioPort.

    Immediately after the coroner’s statement, BioPort issued a general denial, including a claim that they had never heard anything about such reactions at the plant.  This statement was hard to square with the testimony of Mr. Dunn’s wife, who claimed that BioPort actually called several times to see how Richard Dunn was doing and called doctors for him. Either way, her testimony and the coroner’s finding was significant for me because it offered some legal hope for David Ponder, Jason Stonewall, and Vittolino Arroyo.

    Part of the basis for the judge’s ruling in our cases was that we had been unable to show any serious adverse reaction to the vaccine that would justify someone refusing the shot. As I listened to some of the stories of people on the panel, I realized that there were some seriously injured people. One young man, who had begun to have lesions that looked like burn marks all over his body immediately after he received a shot, testified about how he had lost his vision and continued to have medical problems. Incredibly, his father had served in the Army also in Vietnam and had cancer from the defoliant Agent Orange. An Army Major, John Irelan, detailed how Air Force doctors had refused to connect his illness with anthrax and blocked his filing of a VAERS form.

    This refusal of military doctors to even acknowledge adverse reactions was a common theme that I heard repeated by many servicemembers. It was disturbing because it allowed Major General West, in the panel that followed ours, to claim that “of all the people that were here today, there was only one person that has a medical diagnosis that directly links it to vaccine.”[ii] In other words, if military doctors do not diagnose it as anthrax related, then it’s not anthrax related, and therefore there really aren’t that many adverse reactions. Even responding to the coroner’s report finding a systemic reaction to the vaccine General West claimed that “[t]here are other medical experts who believe it [the death] was not [AVIP connected].”[iii] It became clear to me the military wanted it to be a battle of experts and the DoD could always trot out its own medical personnel and how could anyone gainsay them, given the classified nature of DoD vaccine research? And who would dare to question a doctor’s impartiality or medical opinion, even though they were essentially under orders and saying what their employer wanted them to say?

    This is yet another sordid aspect of the anthrax program – the compromise of military medical professionals in service to a corrupt and illegal DoD vaccine program. Report after Congressional report and inquiry after Congressional inquiry reveal that military personnel were not told required information about vaccines or medications, and worse yet, told only that they had to take it. Congressional and GAO reports detail this repeatedly, from the Gulf War’s use of investigational drugs to failed recordkeeping attempts in Bosnia with the encephalitis vaccine. The anthrax vaccine was no different, in large part because the DoD, from the program’s inception, made it a “commander’s program.”[iv] This oft-repeated phrase transformed the medical officer from an independent expert bound by his profession’s ethical rules to provide medical care to servicemembers into a Commander’s staff officer responsible solely for ensuring that the “commander’s program” is carried out, with such trivial consideration as laws or medical ethics thrown in the garbage. Medical officers were given nothing more than talking points around the AVIP, entirely from DoD briefing slides and a DoD website. When I cross-examined the Group Surgeon for Third Force Service Support Group, he acknowledged this was explicitly the case, all while still defending the program.

    During the government’s direct examination, the doctor made broad, sweeping pronouncements about the AVA’s effectiveness against aerosolized anthrax. When I questioned him about the manufacturer’s IND application filed in 1996, he was unaware of it. His answer was that there “may be some political ramifications why they filed that. I don’t know.”[v] I questioned him about the rhesus monkey studies using the AVA and his knowledge of them.

    Q:   . . . have you read the actual results of the study?

    A:  I haven’t read the actual study.

    Q:  Well how do you know then that it is what you said it is? What is your testimony based upon?

    A:  Based upon the briefing sheets that I get. I also looked at the DoD anthrax website which is information that we have –

    What was interesting to me about the exchange wasn’t just his ignorance about the most basic aspects of the vaccine or the program, but was that people refusing the vaccine, who are still patients like any other patient, were now “they” and the doctor and the DoD were “we.”

    This is what happens to those who refuse. Even doctors, who should appreciate more than anyone patient fears about taking shots, had become zealots in defense of the anthrax program. In no other medical treatment regime do we find doctors in lockstep with a military commander about the nature of a medication or treatment. The DoD and military leaders were not providing briefing slides or medical information about Hepatitis B, for example. Or Japanese encephalitis. In those cases, the commander relied upon the expert advice of the doctor to advise the commander of the need for a particular treatment or medical intervention. Somehow with the AVA, however, the entire process was reversed. The histrionic portrayal of the biological warfare threat was such that commanders were now in the position of advising doctors about the necessity of treatments and, more importantly, about the history, background, and safety of such treatments. Had the doctor at Stonewall’s trial looked in a basic microbiology textbook, he would have found that among thirty-six vaccines, the anthrax vaccine was the only one listed under the category “special immunization and experimentation.”[vi]

    Unfortunately, military doctors, non-warriors in a warrior culture, found in biological warfare a chance to be in a position heretofore unheard of for military doctors, as a kind of “biological warfare intelligence officer,” using their medical expertise to advise commanders about the “threat” from disease via biological attack. In the past, the threat from disease was no different for the military than it was for the civilian population and the military doctor’s role was much like a civilian doctor’s: treat people for illness and injury, using preventative medicine to the extent possible. In the Gulf War and post-Gulf War, doctors became special advisors, responsible for ensuring that a vaccine – now considered a part of “total force protection” – was administered to the troops, no matter what. Military doctors stepped all too willingly into this role, abandoning professional objectivity in an effort to be “part of the team.”[1]

    The media bombardment surrounding the anthrax threat allowed doctors to convince themselves of the necessity for their involvement. If it is psychologically understandable, it is still professionally inexcusable. Doctors have an ethical duty to their patients outside of their job as officers, just as lawyers do to the law. If a commander told his staff judge advocate that he was contemplating murdering innocent civilians, then the lawyer would be obligated not simply to advise the commander not to do it, but to stop him from completing such unlawful action or to turn him in for the violation if he went forward. George Annas, in his excellent article on this subject, addressed this question with respect to military doctors.

    What should physicians in the military do when asked to administer investigational agents without the informed consent of the soldiers? Even if such administration is legal . . . it is unethical and following orders is no excuse for unethical conduct, even in combat. It would seem that the only justification a physician could have for participating in the administration of experimental or investigational agents without consent is that the physician sincerely believes that the agents are therapeutic under combat conditions. This is a difficult position to defend, because war does not change the investigational nature of a drug or vaccine. Such a decision would also be contrary to military regulations, which state that although a serviceperson must accept standard medical treatment, or face court-martial, soldiers have no obligation to accept interventions that are not generally recognized by the medical profession as standard procedures.

    A related question is whether the military physician is primarily responsible for the health and well-being of the soldiers under the physician’s care (as in civilian life) or must subordinate the medical interests of the soldier-patients to the military mission. Remarkably there is no written policy or standard view on this question in the military. This issue deserves critical attention in peacetime, because it is not susceptible to rational thought during wartime. An unequivocal policy upholding traditional patient-centered ethics, although not legally required, seems the most responsible position for U.S. military physicians to take.[vii]

    Unfortunately, there still was no unequivocal policy by the respective service Surgeons General on the military doctor’s role. In the case of the anthrax vaccine program, it is important to realize that we were not at war. The rule regarding informed consent has gone from the Nuremberg Code’s absolute position, to Desert Storm’s wartime exigency, to the peacetime potentiality of terrorism. This happened with very little scholarly or public debate and notwithstanding the harms suffered by World War II, Korean, Vietnam, and now Gulf War veterans from investigational treatments administered without informed consent. Mr. Annas, who holds a law degree and a Master’s in public Health from Harvard, testified before the FDA rulemaking committee regarding the Rule 23(d) waiver.

    In December 1995, I was invited to participate in a meeting on Rule 23(d) sponsored by the Presidential Advisory Committee on Gulf War Veterans’ Illnesses. During the meeting, DOD representative continually referred to American soldiers as “the kids” and the responsibility of DOD to protect “the kids.” I probably waited too long to tell him that I found this offensive, but he apologized for his choice of words. Nonetheless, the words are telling. Rule 23(d) treats American soldiers like kids and applies the basic rules for research on children to them with regard to consent – someone else makes the decision for them because they are seen as too immature to make it for themselves. For an adult this is always an affront to human dignity and disrespectful of personhood. In this regard, Rule 23(d) is a mistake and an aberration.[viii]

    This reference to soldiers as “kids” has another, more subtle, persuasive use.  While Mr. Annas viewed the use as derogatory with respect to consenting adults, it also conveys to the listener that the speaker is seeking to protect children, and who could possibly argue that protecting children is not a worthy cause? Of course, as Mr. Annas pointed out, military members are hardly children.

    Mr. Annas was also troubled by the DoD’s insistence that keeping the waiver of Rule 23(d) in place was “consistent with law and ethics.” As he notes,

    Soldiers are not pieces of equipment. They have numbers, but they retain their humanity and basic human rights. DOD should have exercised a third kind of courage – the courage to admit its mistake – and asked FDA to rescind Rule 23(d) and removed this pointless blot on our military laws. Instead, when Public Citizen petitioned FDA to revoke the rule in 1996, DOD supported continuing the waiver of consent rule as “fully consistent with law and ethics.” In mid 1997, FDA asked for public comments on what should become of the rule. The answer remains simple: it should be rescinded because it violates every code and ethical principle developed since World War II to regulate research with human subjects, and it is unacceptable to permit commanders to turn soldiers into research subjects.[ix]

                                                                                                                                                                                                               

    Endnotes

    [1] This phenomenon is by no means limited to doctors. I have noticed many other non-combatant staff advisors guilty of doing the same thing, abandoning professional doctrines in an effort to please commanders and “get the job done.” Lawyers who serve as Staff Judge Advocates are known for this, frequently acting as if they are the personal attorney of the Commander. I have sat in classes given by senior judge advocates, more than one, who have stated that “the challenge is not just to tell the Commander what the law is, but to find a way to allow him to do what he wants, to fit that within the law.” I call that spin. Better to tell a commander that his actions are unlawful, defend that position if it is honestly held, and suffer the consequences than to prostitute one’s legal opinion and engage in some scholarly rationalization to justify going along with the commander.

    [i] Testimony of Major Jon Irelan, US Army, before the House Government Reform Committee, Oct. 5, 2000.

    [ii] Testimony of MGen Randy West, USMC, before the House Government Reform Committee, Oct. 5, 2000.

    [iii] Id.

    [iv] “Department of Defense Anthrax Vaccine Immunization Program AVIP: Unproven Force Protection,” Report of the House Comm. On Govt Reform, Apr. 3, 2000, p.3.

    [v] Testimony of Cdr Gregory Chin, USN, in U.S. v. Stonewall, record at p.81.

    [vi] Principles and Practice of Infectious Diseases, 4th ed., p. 2770 (1995).

    [vii] George J. Annas, “Protecting Soldiers from Friendly Fire: The Consent Requirement for Using Investigational Drugs and Vaccines in Combat,” Amer. J. of Law and Medicine, Vol. 24, Jan. 1, 1998.

    [viii] Id.

    [ix] Id.

  • Chapter 15 – The Stay

    “Well, if they’re going to issue the stay at all, now would be a good time! I mean, if no stay today, by tomorrow night my guy is eating with the big metal spoon, if you know what I mean.” I’m on the phone to appellate defense in Washington, D.C. I look at my watch. The digital face reads 00:31. Ten-thirty in the morning east coast time.

    “Alright, bye.” I hang up. I’m looking at documents, but I’m not really seeing anything – David Ponder’s record book, letter from his wife, character statements, and I’m trying to imagine how I’m going to defend him tomorrow. I’ve got one last motion that I’ll bring at the close of the government’s case. One last grasp that has a sound basis in law, but the judge will deny it, at this point. It’s a technicality.

    From the beginning I’ve had the sense that they have mischarged the offense, perhaps intentionally. The prosecution has charged it as willful disobedience of a superior commissioned officer. Under the UCMJ, that has a stiffer penalty than the more general charge of violating a lawful general order, such as the order from the Secretary of Defense, to take the anthrax shot. The government has charged it as violating the specific Navy Lieutenant’s order, but there is an old case that stands for the proposition that merely repeating a higher order can not make an orders violation the more egregious willful disobedience of a superior commissioned officer. It is called the “ultimate offense doctrine,” but it probably isn’t going to work. Nothing else has.

    I’m tired. I haven’t slept much, I need a shave, and my back is killing me from my tiny desk chair at home and my broken desk chair at work. I need to get David’s sentencing case together, review my opening statement and closing argument, and make sure all of the documents are in my case file, with necessary copies for each of the jurors…

    My head nods and I realize I’ve drifted off at my desk. I look at my watch and see it’s 2:33 am. I rub my face and decide to take a walk.

    The building is dark and empty, except for me and the feisty Okinawan cockroaches. I stroll the dark corridors, my sneakers making a light tread on the tile. I stretch my arms over my head as I walk to the entrance. Out the window, the open field beside our building is dark. I can barely see the slope that I know rises up to a road that runs next to the next set of office buildings and the barracks.

    I hear the phone in the clerk’s office ring, but there’s nothing particularly unusual about that at this hour because of the time difference; people frequently fax documents from the States during our nighttime in Okinawa. The fax ticks away, a counterpoint to the flying bugs banging into the glass on the door and the light just outside of it. Tick-tick-tick. In seven hours, David Ponder is going to be facing a jury, and likely going to jail. Unless that fax. . .

    I walk hurriedly to the defense clerk’s office and go to the fax machine behind the clerk’s desk. Letter-sized sheets are spitting out, face down. I grab one and flip it over to see if it has anything to do with me. The cover sheet is from the Washington Navy Yard. I grab the whole stack while more keep sliding out.

    My eyes flick over the words.

    “YEAHHHHHHHHHHH!!!!!” I let out a guttural yell that echoes throughout the empty building. “Can you feel that, huh!?! Baby, can ya’!?” My best Ace Ventura, hips thrusting, fist pumping. I want to cry with relief. We beat the clock by seven hours. I’ve kept my promise to David and his wife, to Jason Stonewall, and Vittolino Arroyo. We have a stay from the Navy Marine Corps Court of Criminal Appeals. No one’s going to jail tomorrow.

                                                                                                                                                                           

    I take my time packing up and make a few copies of the stay. Before I leave, somewhere near 3 am, I take a ten-penny nail and hammer the stay to the prosecution’s office door. I don’t do it right through the middle, however, because I’m still a Marine Officer and someone might bitch to the CO about a nail in the door. I hammer the nail just deep enough to look like someone was careless; but not all the way through the door, for example. I also place the nail an inch or two above the middle of the sheet, close enough to the top of the sheet that it doesn’t look like it was intentionally in the middle, but far enough down that someone will have to either rip the paper in half to get it off or pry out the nail. It’s an asshole move, to be certain, but I know it might be all the satisfaction I’m going to get in the long run, so I indulge myself. It’s the little “fuck yous” that matter in life. It won’t be the last laugh, but it’s enough to make me smile as I walk to my car for the drive back to Kadena Air Base officer housing and my wife and four daughters.

  • Something, something, animals are more equal, something, something

    I honestly try not to flip out at the news.  It more or less has become a part of life and others might argue one should be aware of current events in order to be a good citizen.

    Then something like this comes up, and breaks my chill.

    This is my review of La Cumbre Piña Quercus

    So what part of this aggravated me?  Was it the part where a US District Judge overruled a lower court’s ruling the Covington Catholic school boy’s lawsuit for libel in the wake of a 16 year old kid having the temerity to smirk at a guy banging a drum and shouting in his face, and to eventually be called racist by social media, the legacy media, and some politicians?  No, of course not—it was this part:

    The students sued the Massachusetts congresswoman and 11 other public figures who criticized the students, including New York Times reporter Maggie Haberman, actress Kathy Griffin, activist Shaun King and U.S. Rep. Deb Haaland.

    U.S. District Court Judge William Bertelsman ruled Tuesday that Warren acted within the scope of her employment when she tweeted and is therefore protected by sovereign immunity. 

    “The Court concludes that the challenged statements by defendants Warren and Haaland — whether one agrees with them or finds them objectionable — are communications intended to convey the politicians’ views on matters of public interest to their constituents,” Bertelsman wrote. 

    The judge also dismissed Haaland, of New Mexico, from the suit. Haaland had tweeted that Phillips was “harassed and mocked by a group of MAGA hat-wearing teens.”

    Attorneys for the students claimed the boys became the target of “a social media lynch mob” that spread misinformation and led to the boys receiving death threats and hate mail.

    Sovereign Immunity.  What is that you ask?  Let me preface that I am not an attorney, nor do I intend to convey the idea that I am one.  That said my graduate degree is in Public Administration and I not only wrote a paper on the matter, I did particularly well on the assignment.  Should one of the law dogs here wish to weigh in, please do so.

    I rule in favor of me. DILLY DILLY

    Sovereign Immunity is a legal concept Americans borrowed from the British.  The idea is to avoid the circular logic in filing a lawsuit against the Crown.  The British Crown set up the courts in part to settle civil disputes between subjects, the rulings which hold the force of law because the court is acting directly on behalf of the British Crown.  Quite frankly, the queen and the rest of her family is either (supposedly) drinking beyond her own government’s recommendation, flying in private jets while whining about climate change, or (allegedly) hitting up jailbait with Epstein…they simply do not have that kind of time.  A subject therefore can file a lawsuit against an individual, or a company that violated that individual’s rights under common law.  What happens if you are wronged by somebody working on behalf of the government?  The Crown enabled the official that wronged you, and you are now asking a court who’s power is derived from the discretion of Crown…

    You see where I am going with this, you cannot sue the Crown.  Even if you could, do you think they will rule honestly?

    But this is America, and we fought a war to get away from this, right?  We did indeed fight the war but didn’t get away from from it.  From the pocket Constitution on my desk, Article III, Section 2 says:

    Unfortunately, if you have a problem with a particular person in the US Government acting under the Constitution, you are stuck going through the courts set up under that same Constitution.  This concept is further reinforced under the 11th Amendment.

    Page break…

    Unfortunately, there will be no lawsuits affecting Ambassadors, other public Ministers and Counsels, and those in which a State shall be Party.  Can you sue a government agency or the state itself for violation of rights?  Of course, but the asshole that did it is immune because he was just doing his job.

    The problem I have with this is the lawsuit is for libel, which is knowingly spreading false information that disparages the subject in print or other forms of media.  Unlike slander, which is spoken, libel has a record of happening making it easier to prove.  Even after an unedited version of the video suggested the story the media told about the incident was wrong, they continued telling the same story saying the MAGA hat wearing Covington kids started an altercation and the dude banging the drum was trying to keep the peace, and it was racist to smirk at the guy.  Only a racist would wear a MAGA hat.

    Well, Lizzy got busy spreading this misinformation on Twitter.  Per this clown’s ruling, a senator is immune from spreading what any reasonable person can determine is a lie, because a senator giving her opinion on current events falls under a senator’s daily duties.  I for one say this is bullshit, and she should be held personally responsible for spreading this lie.  Being a senator and now a candidate for president means the lie will spread faster from the press coverage she will recieve, harming the subjects further than had she done the sensible thing and said nothing at all.

    …but her inability to simply not lie is another matter.

    So what in the hell kind of beer is this?  This is a pineapple sour ale aged in tequila barrels.  I thought this was going to suck.  Arizona has a rather popular pineapple wheat beer that I go for from time to time that I find a bit sweet, but chuggable on a hot day.  This is not like that.  I thought it was going to to be too sour for me to enjoy.  This is not like that either.  Finally, I thought this was going to be a blast of tequila; no, this is not like that at all.  It is interesting, rather expensive ($16), but otherwise well done.  La Cumbre Piña Quercus 3.5/5.

  • Chapter 14 – Secretary Cohen’s “Four Points”

    In December of 1997, the anthrax vaccine manufacturer was shut down and could not manufacture anything related to the AVA. Notwithstanding that hurdle, Secretary of Defense William Cohen announced that before the mandatory program would begin, it would have to meet four prerequisites:

    1. Supplemental testing, consistent with Food and Drug Administration standards, to assure sterility, safety, potency and purity of the vaccine;
    2. Implementation of a system for fully tracking personnel who receive the anthrax vaccinations;
    3. Approval of appropriate operational plans to administer the immunizations and communications plans to inform military personnel of the overall program;
    4. Review of health and medical issues of the program by an independent expert.

    (My emphasis added). One cannot help but wonder why condition number one would need to be in place if the DoD was confident in the safety and potency of the AVA, as it had started saying publicly. In fact, this appears to have been nothing more than a media campaign to assuage fears because none of these four “prerequisites” were ever met before the program kicked off, which is exactly why the manufacturer had been shut down in the first instance. Each of these factors revealed fundamental flaws with the program from its inception.

    With regard to point 1, “supplemental testing” may well have been the worst idea for the DoD could have ever come up with because what it demonstrated, unequivocally, was failure of lot, after lot, after lot of the vaccine.[1] One of the first findings in CBER’s February 1998 inspection was that “there is no validation of the length of time sublots are held until they are used in a lot. Sublots have been held longer than three years prior to use. There is no stability data to support this hold time.”[i] Lest this seem picayune, consider a little more history of one particular Sublot:

    Sublot AV456 was produced . . . in 5/95 [and stored] until 3/97 at which time it was transported to the formulation room . . . with other sublots to make FAV039. Here it was discovered that AV456 was contaminated with mold, and it was destroyed.[ii]

    While some may say that the fact that it was caught is good news, it ignores the other, older sublots where mold or other impurities were not caught. One finding (among many like this) is particularly noteworthy:

    Lot FAV023 was filled on 12/13/93 and passed a potency test on 3/29/94. It was submitted for redating on 4/2/97 and was placed in the stability program (zero time) at the same time. It is reported as failing potency on 4/2/97. It was tested again on 8/12/97 and is reported as failing potency. A fourth potency test conducted on 10/6/97 is listed as passing by 0.01. There is no investigation into the original result and justifying the additional testing.[iii]

    This finding is most disturbing because it indicates a testing regime that ignores negative test results – twice! – and somehow chooses to validate a subsequent positive after two negatives. How can one know which test result is correct with two failing and two passing results? And how many people would like to line up, roll up their sleeve, and take their shots from that particular vial of the vaccine? Stability testing of biological products is crucial because of the possibility for these products to break down over time. Note that this lot was “filled” in 1993. Four years later it passes a test by .01 after having failed twice previously. This particular finding is in no way isolated: Lots FAV 010, 011, 018, 021, 022, 025, 028, 040, 041, 042, 043, and 044 all had at least one failed potency test that was not investigated and then a passing result was somehow chosen over the negative one.

    FAV016 has its own uniquely disturbing history.

    Lot FAV016 had 6579 vials rejected due to particulates during post-filling inspection. These particulates were not identified, nor was an investigation conducted. The batch was released.

    Someone, somewhere, had unidentified “particulates” injected into them. As a practical aside, one has to wonder how those individuals will get VA compensation if they have an illness as a result of this contaminated product being injected into them in light of the DoD’s positions that there had only been 74 adverse events from the vaccine.

    The list of violations goes on and on and includes several different lots being tested and found with such contaminants as “penicillum species” – a danger to anyone allergic to penicillin; cladosporium – a fungus that can cause infections leading to “rough skin, black lesions on the hands, and sometimes a brain abscess”; altenaria – a fungus that can cause dermatitis in humans; micrococcus – a contaminant that is relatively harmless to humans; staphylococcus saprophyticus – a significant cause of urinary tract infections; staphylococcus epidermis – a significant cause of opportunistic infections, usually for those with some skin puncturing, such as needle/IV intrusions, medical appliances, or surgery; and staphylococcus capitis – another infection causing bacteria.

    Despite all of these findings and more in February of 1998, the program was launched on May 15, 1998, with Secretary Cohen claiming, with a straight face, that “all conditions for implementing the anthrax vaccination program for the total force have now been met.”[iv] There is simply no possible way Secretary Cohen could have said that in good conscience if he was aware of the inspection results in February. And given everything going on around the program, it is impossible to imagine that he didn’t know – because he manufacturer “voluntarily” shut down for “renovations” in January 1998. In reality it shut down as a result of the Notice of Intent to Revoke letter by the FDA, otherwise the February inspection results would have resulted in the facility’s license revocation.

    The second condition of the program was tracking of immunizations. Two DoD briefers talked extensively on November 6th, 1997, about a new program that would be used to track immunizations and of the terrific job the new system had done in Bosnia.[v] At a March 1998 Senate Armed Services Committee hearing, however, Dr. Randolph Wykoff, the Associate Commissioner for operations at the FDA, and Mark Gebicke of the GAO, pointed out that the Bosnia experience left a lot to be desired, particularly of the tracking of immunizations under an IND protocol for an investigational encephalitis vaccine.[vi] In fact, one report used the word “abysmal” to describe it.[vii] Once again, the Assistant Secretary of Defense for Health Affairs promised to get better, but also talked about a new procedure for getting relief from the FDA from the requirements of an IND.  The FDA associate director maintained that the “FDA firmly believes the IND process, as defined in our rules and regulations, is sufficiently flexible [for DoD’s needs]. Additionally, FDA is convinced the Department of Defense has the scientific, clinical, and logistic capability necessary to comply with the requirements of the IND process.”[viii] Evidently, however, they could not and did not do it in Bosnia. A GAO report issued the same day stressed the importance of being able to track vaccine immunizations in order to ensure “that (1) sufficient supplies of vaccines will be available at the various worldwide immunization sites; (2) vaccines that are older than their 1-year shelf life are destroyed; and (3) records of vaccines received, administered, and destroyed are kept to allow for monitoring and tracking.”[ix] Worse yet, the GAO found that during the “Bosnia deployment in 1997 . . . DOD could not account for more than 3,000 (20 percent) of the total number of doses sent to Bosnia.”[x]

    Requirement number three was that there would be approved operational plans to communicate to service members about the anthrax vaccine program. Whatever the operational plans were, in May 1999, the Department of the Air Force circulated a memo to its judge advocates, specifically defense counsel, telling them that “a small number of military members have refused to follow their commander’s direct order to take the [anthrax] vaccine” and that the cause of their fear in taking the shot is “misinformation obtained from web sites set up by special interest groups[.]”[xi] This was a frequent refrain of the DoD, in front of Congress and in the press. The memo also points members to the DoD’s own website, which was established after the program had begun, in order to “counter” in DoD parlance “internet misinformation.” Evidently then, in March of 1998, when the program was about to begin, prong number three hadn’t been met, either.

    It is worth noting that the Army’s AVIP Agency existed solely for the promotion of the anthrax vaccine. It was budgeted at $74 million over a six-year period (FY99-FY05).[xii] No other military medicine program has ever needed to be forced on servicemembers with an orchestrated campaign of this type. William Arkin, a defense writer and former Army intelligence officer observed that “. . . this is the Pentagon versus its own service members. It is a depressing window into the breakdown of discipline and basic confidence in the political and military leadership. That has nothing to do with the Web.”[xiii]

    Criterion number four probably cost the DoD as much credibility (if one can say it had any to begin with) as number one. It would be comical were it not for the stakes involved. Secretary of Defense Cohen announced that there would be a “review of the health and medical aspects of the program by an independent expert.”[xiv]

    Doctor Gerard N. Burrow was the doctor who allegedly reviewed the program at the request of Deputy Secretary of Defense Rudy DeLeon. Dr. Burrow concluded that “[t]he anthrax vaccine appears to be safe and offers the best available protection against wild-type anthrax as a biological warfare agent.”[xv] Unfortunately, Dr. Burrow is a professor of gynecology at Yale University School of Medicine, a specialty that one would not normally associate with some expertise in weaponized anthrax toxins. When that unfortunate snippet from his CV leaked out, Dr. Burrow was subsequently asked by Congress to testify about his review at a 29 Apr 1999 hearing. He declined to appear. Instead, in a 26 Apr 1999 letter to Representative Christopher Shays (R-CT), Burrow stated that

    “[t]he Defense Department was looking for some [sic] to review the program in general and make suggestions, and I accepted out of patriotism. I was very clear that I had no expertise in Anthrax and they were very clear they were looking for a general oversight of the vaccination program.”[xvi]

    The DoD’s claims of misinformation on the internet had a particularly hollow ring in light of its blatant lack of honesty and candor in having something as simple as an independent review conducted. Nothing was ever done about this lie that was foisted off on American servicemembers. No one has ever been taken to task for this laughably blatant fraud perpetrated on U.S. military members and the broader American public.

    Thus, in the end, the DoD’s four-point plan to reassure the public and servicemembers of the safety of the anthrax program – as a prerequisite to beginning inoculation – was nothing more than a PR campaign that ultimately cost the DoD credibility that it did not have to spare. As the truth came out, and was certainly made available on the internet and elsewhere, the DoD’s cries of “misinformation” went unheeded. Service members on active duty and in the reserves began to refuse or leave the service rather than take the anthrax shot.

    If the DoD’s actions appear incredible, the FDA’s inaction is equally baffling.  The FDA is charged, under the Administrative Procedures Act, with the duty and authority to regulate, among many other things, the safety of drugs and biologic products. The FDA has had no hesitation in cracking down on manufacturers who do not comply with its regulations or decisions. The cases in the D.C circuit are legion with the FDA disciplining manufacturers who try to market a drug for a purpose not clearly delineated on the approved labeling or who otherwise fail to comply with IND protocols.[xvii] For some reason, however, in the case of the AVA, the FDA had an absolutely incestuous relationship with the DoD, a third-party who was NOT even the manufacturer! Letters were exchanged between the two agencies regarding non-compliance with IND protocols after the IND protocol was not properly administered in Bosnia. At the March 17, 1998, hearing, the following colloquy took place on this issue between Senator Rockefeller and Dr. Wykoff, the FDA’s associate director for operations.

    Rockefeller:  . . . It’s also not clear to me that FDA’s shoes are entirely clear or clean on this matter. In fact, some would say lax.  I think that FDA and DoD have been exchanging letters about all of this for some months now. And the fact is that seven years after the Gulf War, the situation is still not resolved. If DoD does not adequately answer FDA’s questions with respect to these matters and others, what is FDA going to do about it?  . . . And why, for example, was it necessary for the Presidential Advisory Commission to address the waived informed consent matter six years after the end of the war? So I put to you what FDA would recommend and would do if DoD does not come in compliance more?

    Wykoff:  . . . We have tried very hard to make sure that they are absolutely clear what our rules and regulations are and what our expectations are. We believe that they understand that. 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.

    Rockefeller: And if they don’t, is there anything that you can do about it?

    Wykoff: Yes, sir. Obviously, there are a range of options that we have. We would have to determine what the specific concerns are. That drives what are specific actions would be.

    Rockefeller: What are some of the options?

    Wykoff: Well, as we interact with any trial sponsor, we learn more about their ability to conduct IND trials, we would be more or less willing to grant waivers or exemptions to particular requirements.  We could hold them to more – all of the requirements as outlined in the rules and regulations – based on their performance.[xviii]

    It boggles the mind to think that the first words out of the FDA’s mouth are talk of waivers for non-compliance with regulations, particularly in light of DoD’s history in this area. There was, and is, a clearly documented squeamishness on the part of the FDA to step in and bring the DoD into compliance. In downright shocking testimony before a House Committee, Dr. Kathryn Zoon of CBER was questioned by Rep. Christopher Shays (R-CT) about the FDA’s regulatory responsibility.

    ZOON: This is a licensed vaccine. If a physician uses it or DoD uses it, that does not really fall under our jurisdiction.

    SHAYS: So it’s your statement before us now that if DoD doesn’t abide by the protocol, you have no responsibility? That you have set out a requirement? Who is responsible then? Who’s going to make sure that DoD abides by the protocol, if you don’t do it?

    ZOON: We don’t have the authority.

    SHAYS: I can’t believe – I just want to say, Dr. Zoon, I cannot believe that you have just said under oath that you do not have the responsibility to deal with this issue or the authority. You said you don’t have the authority.

    ZOON: I said – yes, that’s correct.

    SHAYS: That is your testimony.

    ZOON: We don’t have the authority.

    SHAYS: Well then who is going to protect our men and women if you aren’t going to do it? Who? Who has the authority?

    The tricky part of this testimony is that it is partly correct. The FDA does not regulate end-users of a product, normally. That is, they do not tell an individual doctor, for example, that he cannot use a drug off-label. Two important caveats to that “normal” example, however. First, the normal patient can’t and isn’t being compelled by their doctor to take anything; they can decline, and they can also sue if something happens as a result of the doctor’s malpractice. A military member has neither of those options. Second, and more directly on point, if the end-user is participating in a clinical protocol, then the FDA does regulate that user. Thus, the DoD’s participation in BioPort’s IND application in order to get an indication against aerosolized anthrax should make them subject to FDA regulation, just as the DoD was during the Gulf War when applying for a Rule 23(d) waiver. FDA’s willingness to accede to DoD’s interpretation essentially allowed the DoD to completely slide on their responsibilities. Some lawyer’s or regulator’s intentional misinterpretation of the FDA’s own regulations resulted in an open abdication of the FDA’s regulatory role over the AVA.

    FDA officials have repeatedly acceded to DoD doctors’ interpretations of the anthrax vaccine label, as well. This is an absurdity, particularly appalling in light of the DoD’s involvement in the manufacturing process. The DoD fundamentally became a manufacturer, for all intents and purposes, and the FDA looked the other way, hiding behind the fiction that the DoD was an “end-user” when convenient. The DoD was involved from the very beginning in the development of the anthrax vaccine. Additionally, when problems arose with the manufacturer, the DoD sent in its own ‘inspection’ teams to ensure the supply of the vaccine. The DoD had paramount liens on every piece of equipment that the manufacturer has. A GAO report in June 1999 found that

    DOD has made a significant investment in renovating BioPort’s biologic facility to meet the military’s requirements for anthrax vaccine . . . Since 1988, DOD has provided about $112 million in contracts, including options, to help ensure the viability of the anthrax vaccine biologic facility. As shown in figure 1, DoD’s contracts provided monies to (1) produce the vaccine, (2) renovate and expand the production facility, (3) provide various support services, and (4) purchase equipment to enhance production capacity. DoD has also provided contract terms and conditions to help ensure the success of the anthrax vaccine program. For example, under Public Law 85-804, which allows for government indemnification of contractors for unusually hazardous risks, DoD indemnified BioPort against product liability. In addition, DoD agreed to allow the company to sell up to 200,000 doses of anthrax vaccine to others, using government-furnished equipment rent-free, after DoD’s requirements are met.[xix]

    Amazingly, this is chump change compared to what the Defense Contract Auditing Agency found in 2000! That report led to an Inspector General Investigation. Notwithstanding numerous audits that found that the company was not financially viable, BioPort requested contract amendments that included $1.28 million in bonuses for senior management that amounted to 109% of the managers’ base salary. This was deemed an “unreasonable expenditure” by the DCAA in light of “BioPort’s current financial condition.”[xx] Okay, so someone disapproved, right? Well, sort of, because the manufacturer had almost no real financial incentive to produce an FDA approved vaccine under its contracts with DoD to begin with: the contract paid the manufacturer 90% of the contract price before the FDA ever inspected the vaccine. Yes, read that again.

    Put another way, BioPort only got paid 10% more for the product being approved by the FDA. At one point, the Department of Justice was looking into criminal charges as some $6 to $8 Million of the money provided to the manufacturer was unaccounted for.  Additionally, the fact the former Chairman of the Joint Chiefs of Staff Admiral William Crowe was a co-owner of the facility, as well as Dr. Robert Myers, (formerly of MDPH and MBPI) can hardly escape attention. Crowe was the first senior military officer to have come out publicly in support of then-Democratic party candidate for the Presidency, Arkansas governor Bill Clinton. While both Crowe and Myers disavowed any “inside” preferential treatment from the DoD, one must wonder if the decision to award BioPort the contract had anything to do with either’s presence as an owner. Finally, emails from inside the DoD suggest that the agency actually had its own people “on site.” During hearings held by Representative Christopher Shays in May 1999, an email was sent from Brigadier General Eddie Cain, the Director of the Joint Program Office for Biological Defense, to an Army Colonel John V. Wade. In the email Cain warned that “[I]f you think Congressman Shays was critical of the current relationship between FDA & DOD, wait until he finds out that DOD is calling the shots on-sight.” [sic][xxi] When this email surfaced during the court-martial of Air Force Captain (and medical Doctor) John Buck, the FDA had “no comment.”

    The FDA has, for whatever reasons, backed down from the DoD to the point that after the warning letters, the notice of intent to revoke, and a failed inspection thereafter, the agency still withheld pulling the manufacturer’s license because the DoD interceded on behalf of the company. In a June 25, 2000, interview with the Vancouver newspaper The Province, Mark Elengold, the Deputy Director for CBER, explained what happened.

    The FDA held off pulling the licence, in part because it would have left the U.S. Department of Defence [sic] – which had just announced that all soldiers were to receive anthrax vaccine – with no domestic source.

    “This is a one-source product so we tend to try to work with firms and put additional monitoring steps in to avoid revoking the licence,” said Elengold.  The prestigious British medical journal Lancet reported at the time that ‘a plea from the Pentagon has prevented an ‘eleventh-hour’ closure of the only U.S. producer of anthrax vaccine,” according to an e-mail to DND [DOD?] medical headquarters in February 1998.

    Elengold confirmed the Pentagon sat in on a crucial call to the company in which he discussed revoking the licence.”[xxii]

    Electronic mails surfaced in and around 2000 show not only did the DoD convince the FDA not to revoke the license, but DoD also attempted to bully both the manufacturer and the Government Accounting Office at the same time. In one e-mail, a Pentagon official discusses how other agency supervisors were urging the U.S. Food and Drug Administration and the manufacturer of the vaccine to release lots that had been held up for scrutiny by them (the FDA). This despite Secretary Cohen’s public insistence on supplemental testing to ensure safety of the vaccine, one should remember.

    On Feb. 22. 1999, Dr. Michael Gilbreath, a civilian Pentagon biological defense employee sent an email to U.S. Army Brig. Gen. Eddie Cain, then Director of the Joint Program Office of Biological Defense (JPOBD). Gilbreath wrote that he had “received information this morning from BioPort that individuals within the DOD contacted them and threatened that DOD would circumvent BioPort and contact the FDA regarding availability of anthrax vaccine lots currently under review at the FDA . . . Any such actions by DOD would be inappropriate.”[xxiii]

    E-mails also reveal that the Pentagon was having trouble countering the U.S. General Accounting Office’s assertion that the vaccine is improperly licensed, and that it has not been proven safe and effective. Cain indicated in one e-mail that then Secretary of Defense William Cohen would be writing to the GAO, whose findings have consistently gone against the Pentagon, to protest “the expertise put on this (vaccine) project” by the watchdog agency.

    “If we cannot answer these questions, we (DOD and the Administration) are in big time trouble,” Cain said in the May 3 e-mail. “…We are digging ourselves a hole that will be too difficult to crawl out of.”[xxiv]

    The FDA also stood by when adulterated vaccine was shipped to the Canadian military and when 59 Marines were given shots from expired lots of the vaccine.[xxv] The FDA’s complicity with the DoD’s actions has left service members with no recourse but to either take the shot, be court-martialed for refusing, or leave the service somehow if their commitment allows it. If the service member simply will not take the chance on the vaccine’s safety, the penalty for refusing is court-martial with a certain conviction. Military Judges simply would not hear that the vaccine is investigational, nor would they even allow service members to present that information to a jury. The FDA’s refusal to act leaves the judge with an out: if the FDA thought it was investigational, why wouldn’t they just issue an opinion to that effect? Worse yet, some military judges would not wade through the necessary materials in order to understand the FDA regulatory process and what an IND is, or they would find that the Secretary of Defense’s actions were in legal parlance “non-justiciable” disputes between “co-equal branches of government.”

    The member who fights will be convicted and punished. When an Air Force Doctor, John Buck, tried to submit evidence that the specific lot that he was to have received, FAV044, was subject to a recall because it was expired, the judge did not allow the evidence to come into court. The only option left for service members was to resign quietly, leave at the end of a service obligation, or fight behind the scenes to ensure that the law is followed. That is what a group of persistent officers had been doing from the word go.

    Endnotes

    [1] It would take up too much space to detail all of the failed lots, for their various reasons during the February 20, 1998, CBER inspection on the lots of AVA. Some of the more egregious violations are listed. See CBER Inspection report dtd 2/20/98 for a complete listing.

    [i] FDA Form 483 Inspectional Observations Feb. 4-20, 1998.

    [ii] Id.

    [iii] Id.

    [iv] May 15, 1998, SecDef memo.

    [v] Nov 6, 1997, background briefing

    [vi] Mar 17, 1998 Senate Hearing, Committee on Veterans Affairs Holds Hearing on the Nomination of Togo West as Secretary of Veterans Affairs and on U.S. Biologic Vaccines for Gulf War Veterans.

    [vii] “Abysmal” tracking job quote ????

    [viii] Id.

    [ix] GAO Report T–NSIAD-98-83 p.8 (March 17, 1998).

    [x] Id.

    [xi] 18 May 99 AF memo

    [xii] Charles Cragin, PDASD Reserve Affairs, testimony, 3 Oct 2000.  See: http://www.house.gov/reform/hearings/healthcare/00.10.03/cragin.htm

    [xiii] William Arkin, “Bugged by the Net”, Washington Post online, 27 Sep 1999.  See: http://www.washingtonpost.com/wp-srv/national/dotmil/arkin092799.htm

    [xiv] AVIP Impl ltr 18 May 98

    [xv]  See: http://www.defenselink.mil/other_info/burrows.html

    [xvi] Id.

    [xvii]

    [xviii] Mar 17, 1998 Senate Hearing, Committee on Veterans Affairs Holds Hearing on the Nomination of Togo West as Secretary of Veterans Affairs and on U.S. Biologic Vaccines for Gulf War Veterans.

    [xix] GAO Report GAO T-NSIAD-99-214,  (June 30, 1999)

    [xx] IG Report dtd March 22, 2000.

    [xxi] Dave Eberhart, Stars and Stripes.  May, 2001.

    [xxii] Ann Rees, “Their Dangerous Dose”, The Province [Vancouver, Canada], 25 Jun 2000

    [xxiii] E-mails Suggest Pentagon Pressured FDA On Anthrax Vaccine, Thomas D. Williams, Hartford Courant, May 17, 2001.

    [xxiv] Id.

    [xxv] See Most Dangerous Dose (Canadian article on vaccine) and GAO report on Marines T-NSIAD-00-36.

  • Chapter 11: United States v. Stonewall, July 2000

    “Are you ready?’  Justin and I collected our paperwork. I had defended Marines and sailors facing a lot more time or charged with much more serious crimes, yet I was more nervous than I had ever been before walking into court.

    “Hope so.” I muttered. I did not have my usual confidence. It wasn’t because I didn’t believe I would give a good presentation, or that the law and facts weren’t on my side – which is the norm in criminal defense. It was because I knew that it wouldn’t matter. I had reached the inevitable conclusion that no matter what I did, the judge was not going to find the order to take the anthrax vaccine unlawful or, even a lower standard, allow us to overcome the government’s presumption of lawfulness and get in front of a jury. It simply wasn’t going to happen.

    “Are you ready, Lance Corporal Stonewall?” I turned to Jason Stonewall, who sat in the chair, hands folded in his lap. He had a slight, beatific smile on his face. Jason Stonewall had four plus years of college and was a bright young man; he also had a sterling reputation as a machine-gunner. He believed in the Marine Corps, in its officers, and in its legal system.

    “Yes, sir!” He stood up. Whenever Stonewall spoke, he reminded me of Cuba Gooding, Jr. He looked a bit like the actor except that Stonewall was broader in the face and chest. His voice even had the same raspy quality. I once told him this and he laughed.

    “Captain S,” Stonewall began, “if anybody was ever ready for this argument, it’s you.” I wanted to say thank you, but I just smiled in return, the pinched kind, the one I knew I used to avoid having to say anything inadequate or lie. Lance Corporal Stonewall also believed in us – in Justin and me – so completely and that was what disturbed me the most. I felt like an actor in a badly written play.

    “Let’s go.” We headed to the courtroom.

    We took our seats, me on the inside, closest to the opposing counsel and the judge, Justin at the far end of the table, with Stonewall in between us. Just yesterday we had sat here with our expert witness, Doctor Michael Cohen, on the stand, explaining the microbiology of the anthrax vaccine in detail. While his testimony helped, it hadn’t won the day, which we knew anyway. Mike Cohen wasn’t an anthrax expert. In fact, when he first walked into my office, I pegged him as something else entirely. He had a briefcase and an inquisitive manner and he had read about my court case involving Petty Officer Ponder.

    Reporter, I had thought, except something was a bit…eccentric about him. After a bit of conversation, I finally figured out he was a scientist and felt guilty. I could easily have been Mike Cohen had it not been for choices earlier in my life. I once wanted to be a research scientist and had spent the summer between my junior and senior years of high school studying astronomy at the University of Georgia under the Director of the Astronomy and Physics Department.  Later, I submitted a paper based upon that research to the annual Westinghouse Science Talent Search. I came in the Top Forty in the Nation and was invited to Washington, D.C. to compete with 39 other students for some serious scholarship money. I learned two things at that week-long competition: first, that there were some incredibly smart high school scientists out there(!); second, I was not cut-out to be one of them.

    Mike Cohen reminded me of some of those students. Incredibly intelligent, knowledgeable about his chosen subject matter, but not necessarily able to communicate it outside of the circle of academia to the layperson. Mike had come through when the court refused all of our experts from the states to come testify. A biology professor at the University of Maryland, he had his Ph.D. in microbiology and had offered his help in Petty Officer Ponder’s case because of his belief that the anthrax vaccine was not properly made, nor safe, and nor based upon scientifically valid data. He had Marines in his biology class who had adverse reactions form the vaccine and as a scientist, he had to investigate. I was grateful for his help, but he was just another actor in the U.S. military’s comedy of errors.

    “All rise,” Captain Kolomjec intoned as the Judge came in.

    After getting through the preliminaries, Judge Stone got down to business.

    “Okay. Let’s talk about who should begin first. It is, after all, the government’s motion in limine, but the defense has the burden of rebutting a presumption in the government’s favor. I think we could probably cut to the chase and let the defense go first, given that presumption, unless either party objects.”

    There were no objections. Major Stone turned to me.

    “Sir, you have the floor.”

    I stood up and moved out away from our table and out into the well, the middle of the courtroom.

    “Thank you, sir. First, I would like to point out where we are and where we are going. The government has a presumption in its favor, a rebuttable presumption, which is not impossible to overcome. The defense need only put on enough evidence to overcome that presumption in order for the accused, Lance Corporal Stonewall,” I turned and gestured to Jason, who looked studious with his glasses on, “to get his day in court.”

    “What’s the quantum? I mean, clearly you can rebut, but what is the quantum of evidence required?” Thankfully, I had looked into this. My law school civil and criminal procedure professor had prepared me well.

    “Sir, the case law isn’t clear that it’s a preponderance, but it would certainly seem contrary to notions of fairness if it were beyond a reasonable doubt. Having analyzed this–”

    “Well, is it just some evidence? A scintilla, as it were?”

    “Sir, it is the defense’s opinion that procedurally this is like a motion for summary judgment in the civilian legal system. The government has essentially asked you to find that there are no genuine issues of material fact with respect to the lawfulness of the order and that the accused therefore has no right to get into court at all, sir. Thus, we find ourselves procedurally, in a similar situation to a motion for summary judgment.” I waited for the Judge’s reaction.

    “In reverse, you mean.” He caught right on. That’s what I liked most about Judge Eric Stone.

    “Exactly, sir – in reverse. Therefore, if the accused can show there is or are genuine issues of material fact, then the case should be allowed to go forward. Support for that, sir, comes form the case of Unger versus Ziemniak, which we think is a propos of our current circumstances.” I paused a moment to see if he was following, and as I gathered myself for the crux of this first part, Justin quietly slipped a copy of the Unger case onto the podium for me. Thank you, I mouthed silently, as I tuned to pick it up from the lectern behind me.

    This was the most clever play I had, something I had labored over, discussed with other lawyers, researched, and thought was the one chance we had to win this case. I would never be able to convince the judge straight up to say the order was illegal. It would throw the entire Anthrax Vaccine Program into disarray. A military judge in some obscure outpost on the edges of the Empire – Camp Foster, Okinawa, Japan – was not going to invalidate the entire DoD Anthrax program. I thought I was good, but I wasn’t that in love with my arguments. No, instead, I was simply trying to get the judge to give me one, small thing: let me put what evidence I had before a jury. I might not trust “the system” to get it right, but I did trust military juries. Even though I had only a few months as a lawyer, I had interned as a prosecutor, been a legal officer in my squadron, and been an officer for almost ten years. That experience convinced me of one ineluctable fact: Marines, especially on juries, want to do the right thing and will do so regardless of what it means to broader equities, if they’re allowed to see the evidence.

    I just needed to convince the judge that we were entitled to an opportunity to at least put on some evidence to a jury.

    “In Unger, sir, a female Navy Lieutenant refused a mandatory urinalysis test. Appellate case law by then had made clear the validity of the order to submit to a urinalysis in the military. There was no question about the validity of that order. Such orders had already been challenged on Fourth Amendment and a number of other grounds and failed.

    Lieutenant Unger specifically challenged the validity of the provision in the military’s urinalysis program – in the written order – that required direct observation of the act of urinating into the cup. She filed a motion that the order was unlawful as a matter of law. The trial judge ruled against her and she took an extraordinary writ, an appeal of the judge’s decision, all the way to the Court of Appeals for the Armed Forces.” Judge Stone was leaning forward, squinting, and appeared genuinely interested… or so I hoped.

    “Interestingly, sir, CAAF decided against Lieutenant Unger on the lawfulness of the order. The Court said, as we would all expect, that the order was lawful. However, the Court did not dismiss her claim. Instead the Court found, essentially, that there still existed ‘genuine issues of fact’ about the circumstances under which she would be required to take the test that a jury might find violated her statutory and Constitutional rights. The Court pointed out, for example, while direct observation might be lawful, if the direct observation were required by a male, that might be an “unreasonable” seizure under the Fourth Amendment. Or, if the order in question had a procedure or was being conducted such that the observer was required to watch from within 18 inches, their face, um, right there, as it were,” I held up my hands as if I were a Hollywood director framing a shot, or at least like I had seen other people mimic, “then the Court noted that a factfinder might conclude that was unreasonable.” I had gotten through that entire exposition with no disagreements, no argument from the Bench, which could mean one of two things – either he agreed or didn’t care.

    “This is exactly where we find ourselves today, sir. The defense has, under four prongs I will address in a moment, put forth sufficient evidence to show that there exist genuine issues of material fact about the lawfulness of the order. Like Lieutenant Unger, the process under which the shot is given could be viewed by a finder of fact as unlawful because of matters that the defense has submitted. This does not mean that we will win at trial. It might be that a jury decides, after hearing the defense evidence, that it still was lawful and therefore we lose. But for the purposes of this motion and whether you should find that as a matter of law the order was lawful, there exist genuine issue of material fact about the lawfulness. I would like to turn to those matters now.” Still no disagreement, so I ploughed on.

    “First of all sir, we turn to 10 USSC, section 1107.” I was warmed up now and somewhere I still believed that a military judge, this military judge, might do the right thing. Justin put the statute in front and sat back down.

    “Sir, there is no straight-faced argument that the anthrax vaccine is not an investigational new drug or a drug unapproved for its applied use. Those are the words of the statute. If it is either an IND or a drug unapproved for its applied use, then there is a real question about the lawfulness of the order to take the shot. You have, sir – the defense has given you in previous submissions, the 1996 application by the manufacturer of the drug that requests an amendment to the existing license to get an indication for aerosolized anthrax. This is presumptive – conclusive evidence, I would say – that the drug is an IND.” I paused and Justin slid the affidavit of Mr. Sammie Young onto the podium, another gift from Lou Michels and several other persons who were involved in fighting this back in the states. Sammie Young had been Deputy Director of the FDA during the time that AVA had been licensed and the procedures for licensing a vaccine had been developed. He simply couldn’t believe that the FDA had given the DoD a pass on the whole issue.

    “The idea being why would the manufacturer put it in an IND status if you yourself, if the manufacturer, didn’t think it was an IND,” the military judge supplied.

    “Exactly, sir. Also, it’s an IND because, as you can see from the affidavit of Mr. Sammie Young, former Deputy Director of the FDA, that once a company submits an IND, the drug becomes an IND thirty days after the submission when used for the purposes listed in the IND. Thus, one of the listed reasons for the IND is an aerosolized indication, if it I being used for an aerosolized indication, it’s an IND. Period.”

    “Okay,” the judge held up his hand, “suppose I agree with you.”

    “Yes, sir.” Suddenly this seemed to be going too well and I was wary. I had never had a time, in any real or mock proceeding where a judge began with “suppose I agree . . .” or “suppose I grant your point . . .” that ended particularly well.

    “…That it’s an investigational new drug in accordance with 1107. I mean, you can put on, it appears, a lot of evidence on that and it may in fact, be the case. What I’m really interested in is why should this accused be able to, in law, use 1107 in a military court-martial?” There was a strange moment after that question, of complete Zen-like clarity, where I saw exactly where this was all leading, but my mind simply refused to acknowledge it. I had only had two of those moments of satori, of seeing into the heart of things, in my life. The first was as a troubled teenager, not long after I had run away from home, but the second one was the only other time in my life where I could recall a moment, a specific, measurable instant, where my mind simply refused to accept what I could see was about to happen: that other time, I was in a hover at one-hundred and fifty feet when the second engine on my helicopter quit and we started to lose turns on our rotor head and fallout of the sky. I felt connected across time in that instant in the courtroom, and then my mind walled it off.

    The judge must have caught that something was wrong.

    “I don’t mean to cut you off, but –”

    “No… No, sir.”

    “Your evidence in support of the argument you have just made is extensive, and it is before me to consider. And I’m telling you that I understand the logic of your argument. But I’m interested in why this accused should be able to raise that federal law in this court-martial in the absence of a direct statutory conferral of rights.”

    “Yes, sir, then I’m more than happy to move on to save the court’s time.” But this was a lie, I was not more than happy. Nothing could have been further from the truth. I knew then that the case was over. I should have responded the way I immediately wanted to – “Because it’s a fucking federal law, you honor. You mean we get to ignore federal law we don’t like in courts-martial now? I can’t point out the LAW in a military court, that’s what you’re saying?” I stopped, picked up a pen off of the lectern, and pretended to write something.

    Suddenly, an idea popped into my head that I hadn’t thought of before. I had been reading a ton of constitutional law and perhaps…

    “I would point out, sir, that when we’re talking about substantive rights, it is the history of our country that rights are not stated in the affirmative, as in ‘you have a right to X’, but rather are listed as limitations upon the acts of others, particularly the government. For example, the Fourth Amendment doesn’t say you have a right to privacy, but instead says that you have a right to be free from unreasonable searches and seizures. The Bill of Rights, sir, is almost entirely comprised of limitations on government, not as positive statements of rights. But let’s move on to the more concrete, to 1107.”  My thoughts started to coalesce.

    “Okay.” He paused and wrote something down.

    “First of all, the DoD has always held the position, and still does today, that ‘soldiers are citizens first’ and have the same Constitutional rights as other citizens –’”

    “But that’s a non-lawyer speaking about ethics.”

    “True, sir, but the rule – the law – since Nuremberg has been that informed consent is a prerequisite to experimenting on human subjects. And that was adopted into federal law, sir, at 50 U.S.C. section 1520a. It prohibits military medical experimentation.”

    “But it’s not your position that the force protection argument by the government is somehow a cover for an experiment?”

    “Sir, the motives may be well-intentioned –”

    “– but you’re saying it could be an experiment de facto or something?”

    “No, sir, I am saying it is an experiment. By definition. When you are giving someone a vaccine and you have parts of it that are, by Dr. Cohen’s testimony and the DoD’s own words ‘not well-defined’, you don’t know what’s going to happen. You have a hypothesis that this should provide some protection, but the DoD doesn’t know that. You might have a hypothesis that it doesn’t cause long-term reactions, but you don’t know that because we know there have been no long-term studies. And we also know this: we know that there is a lot of research in the peer-reviewed literature that suggests a connection to Gulf War Illness, that the vaccine causes bad things to happen to the human body, like the reaction to the amount of aluminum in the vaccine that Doctor Cohen talked about, or the high antigen load that he discussed and its possible adverse effect on the immune system.”

    “So, yes, it is an experiment, sir, and unfortunately, the results aren’t in yet. And 2.4 million service members are going to be the guinea pigs.” I should have left the point there, but I couldn’t.

    “We tend, sir, to put ourselves above this – we say Nuremberg was passed because of the Nazis, and we tend to forget that many of their experiments were non-lethal and some of them produced important knowledge for medicine today. But the harm is not just what was done as a result of the experiment; it’s not just the experiment, it’s that informed consent was not obtained from the human beings on the other end of the needle. That itself is the harm.” The judge’s face told me all I needed to know; he thought I was loony. We had had this same argument in Ponder’s case since he was the same judge for all three anthrax refusal cases. His view was that the Nuremberg Code applied to Nazis, not “good guys” in the U.S. military. I decided to move on.

    “Now, sir, why does 1107 apply is the real question?”

    “Well, not necessarily ‘why.’ Let’s assume that Congress wanted consent to be derived in this class of drugs.”

    “Yes, sir.”

    “And that does seem reasonable. I’m with you that Congress wanted to have an informed consent procedure in place.”

    “It’s an individual right, sir. It doesn’t belong to the Secretary of Defense.” He held up his hand.

    “Why should this court not assume that they were putting constraints on the Secretary of Defense? Why should I assume that they weren’t – I mean, what is the intended mechanism of enforcement? It’s silent on it. You’re asking this court to believe – or to infer – that the mechanism to enforce or uphold this right – is to judicially confer rights upon the accused. That is, recognizing the matter on paper and allowing a defendant to use this law to defend himself against such an inoculation.” I was confused.  To this day I still am.

    “To read it otherwise, sir, is to put a strained interpretation on it. Because what else can be done? What else can this person do when they are told to take a drug that is clearly investigational, or experimental? If it is interpreted to mean that it confers nothing to service members, the SecDef could order them injected with anything – arsenic – as long as he thinks it’s a good force protection measure. What do they do in the meantime?  Go to jail while they wait for Congress to hold the SecDef in contempt of Congress?”

    There were a lot better, more eloquent arguments. As I sit here today, I can think of several. But I was spent. I could hear my own incredulity. I could not believe that the judge was saying that if a military order that violates a federal law, even if you can prove it violates federal law, unless that law says specifically that the law is meant or allowed to be used in courts-martial, he simply wouldn’t look at it.

    I felt like a drowning man who knows he is too far from shore to make it, but swims on anyway because of the organism’s instinct for survival. I argued on, but it was fruitless. We took a recess. Back in my office, I fell into my chair.

    “Dale, I think that was one of the best arguments I’ve seen.” Justin patted me on the back. I appreciated the compliments, but I had a feeling he was trying to prop me up.

    “Thanks, man.” Lance Corporal Stonewall sat watching me. I couldn’t look him in the eyes.

    “Lance Corporal Stonewall, can you give us a minute. I want to discuss some other stuff with Captain Constantine?” Stonewall replied yes, stood up, came to attention, and then stepped out. When he was gone I swore.

    “I just couldn’t sit here with him looking at me, knowing that we’re going in the tank.” Justin didn’t say anything for a minute.

    “Think he’s going to rule against us?”

    “It’s a bet. I had a talk with him and Kolomjec in his office, might have been regarding Ponder’s case, but I kept arguing with him about this conferral of rights crap that he says you need. I threw out the hypothetical in our brief, that what if a Lance Corporal is a driver and the General orders him to speed, to do fifty-five in a school zone and the driver refuses and then he’s later court-martialed. Under Stone’s theory, the Lance Coolie can’t plead the speed limit as a defense to the lawfulness of the order; it doesn’t confer any rights! The state legislature never intended it to be used as a defense in a court-martial! Fuck.”

    “Then he started lecturing me about paradigms and how the military is different than the civilian world. ‘It’s a different paradigm, he said.’ Fuck. Fuck.” I was rambling and Justin knew me well enough to let me blow off some steam.

    “Well, what do we do now?” he asked. A pragmatic question.

    “Let me think.” I rubbed my forehead. “Well, he’ll announce his findings and then we’ll probably take pleas. Then, maybe, we’ll set a date for the court next week or something. Once he rules, I don’t think he’s going to give us a lot of time before the court. What’s today, the 25th?” I no longer could keep track of days. I wasn’t sleeping much at all, and when I did sleep it was usually because I had dozed off at the desk in my base housing quarters, with my office in a section of the living room, where my wife would find me in front of the computer if she happened to get up in the middle of the night.

    Justin looked at his watch. “Twenty-six July.”

    “Oh. Okay. Well, let’s get back into court.” I stood up.

    “Dale?” I looked back at Justin and raised my eyebrows. “We gave it our best shot, man. You… we couldn’t have done any more than we did.” I nodded my head, but it didn’t make me feel any better. I walked out the door feeling like a man on his way to his execution.

                                                                                                                                                                                       

    “The defense contends that the order to submit to anthrax vaccination violates a Presidential Executive Order and Federal and International Laws and is therefore an illegal order, so the accused could lawfully refuse to obey. As the court sees it, there are four issues presented. We’ll discuss them in order.” I sat watching as Major Stone read from a sheet he had prepared. He hadn’t written it in the recess since our last session, so I knew that he had been drafting it before I had finished my argument. He’d already decided before oral argument and I’d done nothing to change his mind. I already knew the outcome.

    “The first one, does Executive Order 13139 confer legal rights upon the accused enforceable at courts‑martial?” Just the way he framed the question bothered me. The question wasn’t who got what conferred, it was whether the order was lawful or not. That question had been lost a long time ago and it wasn’t going to get answered in this courtroom.

    “Answer: no. The Executive Order in question is a policy decision of the President taken in his capacity as Commander‑in‑Chief of the Armed Forces. Also, violations of an Executive Order are not judicially enforceable unless the Constitution or Federal Law otherwise requires enforcement.

    “Two: Does 10 U.S.C. 1107 confer legal rights upon the accused enforceable at courts‑martial? No. 10 U.S.C. 1107 imposes obligations on the Secretary of Defense to obtain the informed consent of service members in the event that the Secretary desires to employ an investigational new drug or to use a drug in a manner inconsistent with its FDA approved usage. The text of the law does not directly state that the Secretary’s obligations are also legal rights of service members enforceable at courts‑martial, nor does the statute provide a fair basis for conferral of rights by implication because the statue does not employ wording typically associated with such a legislative conferral of rights. Other federal statutes, in particular, criminal statutes expressly provide for the conferral of rights upon service members. Given that Congress has in the past specifically provided for the rights of service members in other‑statutes and could have done so in 10 U.S.C. 1107, it would be judicial speculation to presume that Congress would desire to do so in this case. In fact, it may well be that Congress does not desire to grant individual rights to two million or so service members, but rather chose to make one officer, the Secretary of Defense, accountable for obtaining the informed consent of service members.”

    I looked down and noticed I was scribbling notes. Habit. None of it made any sense.

    “Finally, along the same lines, any inquiry as to whether or not the Secretary of Defense, a civilian political appointee, has complied with 10 U.S.C. 1107 is a non-justiciable political issue between Congress and the Secretary, that is, it is beyond the reach of decision by military courts‑martial.” There it was. I had known that was coming. There was no way he was going to rule that the Secretary of Defense had violated the law, no matter how clear it was.

    “Issue 3: Does the Nuremberg Code as codified at 50 U.S.C. 1520(a) confer rights on the accused enforceable at courts‑martial?” Now this was the real coup. The Nuremberg Code, despite its clear language, did not apply to one class of persons:  second class citizens, known as U.S. service members.

    “Answer of this court: No. 50 U.S.C. 1520(a) prevents experimentation on service members without their informed consent. The defense claims that the anthrax vaccination program is essentially a large‑scale medical experiment and, therefore, 50 U.S.C. 1520(a) applies. More specifically, the defense argues that because there have been no long‑term studies of the effects of the anthrax vaccination, the DoD ­inoculation program is a de facto medical experiment. This court declines to adopt that view.

    “The DoD vaccination program on its face appears to be a reasonable and time‑tested force protection measure. That is, inoculation against disease designed to counter a real‑world threat of biological attack.” I looked over at Lance Corporal Stonewall. He looked back at me and gently put his hand on my arm, grimacing a little, but other than that, no reaction. It was all I could do not to cry. Some lawyers would say that I had become too personally involved in my case, something I had thought about a lot in my brief time as a defense attorney: my reply would be “so what?”

    “Four: Is an order for a service member to submit to the anthrax vaccination so inherently unsafe and dangerous in light of its proper justification as to make it arbitrary or capricious and, therefore, illegal? Answer: No. The defense has provided no evidence of any death or serious bodily injury that has resulted from administration of the anthrax vaccine to over 1.7 million service members. The government, on the other hand, has presented evidence that anthrax is 100 percent fatal if inhaled, that several actual military adversaries presently have the capability to attack U.S. Armed Forces with aerosolized anthrax, and that animal modeling studies suggest that inoculation may provide a significant measure of protection against aerosolized anthrax attack.” I had heard a Navy doctor explain that he read the DoD website, but we hadn’t been allowed to bring an expert to show the falsity of those statements and conclusions.

    “In sum, then, I find the order to submit to the anthrax inoculation was a legal order as a matter of law and will so instruct the members if that is the forum selected in this case. Accordingly then, based on the reasoning above, as for the two defense requests for experts in this case, those requests are denied.” The cart had come before the horse. We were denied experts to rebut the government’s doctor and that had led to a ruling that our requests were denied. The ol’ Catch-22.

    “Does the defense have any other motions to present?” I stood up slowly.

    “No, sir.” At that point, I finally believed what Lou Michels, our helpful Reserve Air Force attorney and partner in big-time law firm, had said to me on the phone one day: no military judge was going to find the order to take the anthrax vaccine illegal. It wouldn’t matter how twisted the reasoning it took to get there.

    “Then this court is in recess.”

     

  • Chapter 9 – The History of the Anthrax Vaccine Adsorbed (AVA)

    The first use of a human anthrax vaccine took place in 1954.[i] The primary purpose for an anthrax vaccine, like all vaccines, was to provide some prophylaxis for human beings from contracting the anthrax bacteria, which is typically found in cattle and other livestock hides. The people most likely to come into contact with the anthrax spores were (a) livestock handlers, and (b) people who might be handling animal hides in leather-working factories or similar places. The first comprehensive field trial of a human anthrax vaccine was conducted at goat-hair processing mills from 1955-59 in the northeastern United States by Dr. Philip Brachman. This study has come to be known as the Brachman Study because it is, essentially, the only data available on the subject.[ii] In this study, 369 workers in the mill who handled animal hides were vaccinated against the bacteria. The results, while not spectacular, certainly indicated that the vaccine was effective against catching anthrax from handling pelts and hides that had the spores: to be precise, the vaccine trial was designed to provide prophylaxis against contacting anthrax via contact with the skin, the most likely method of encountering the spores. The study showed a “high confidence level of 93% effectiveness” for the vaccine and a low of 65%, a significant spread.

    The Michigan Department of Public Health first produced the Anthrax Vaccine Adsorbed (AVA) under an Investigational New Drug application (DBS-IND 180) in 1966. MDPH filed a license application for the manufacture of Anthrax Protective Antigen, Aluminum Hydroxide Adsorbed in 1967. The specification for manufacture is based on U.S. Patent 3,208,909. The license application references an article published in “Applied Microbiology” that details the production process. The license to manufacture AVA, granted in 1970, has two parts. One license is for the facility, the Establishment License Application (ELA); the other is for the product itself, the Product License Application (PLA). MDPH produced AVA continuously (if in small quantities) from its first contract (PH21-68-2064) in 1968 until 1997 when MDPH split off its biologics division and privatized it into the Michigan Biologic Products Institute. MBPI in turn sold the facility and its licenses to BioPort, Incorporated, in 1998, a subject to which we will return in detail later.

    Bacillus anthracis is a bacteria that survives in its environment by exuding enzymes that break down surrounding compounds, such as fats, proteins, and polysaccharides (complex sugar molecules). The bacteria then absorb these byproducts. In addition to secreting the enzymes, which serve a nutritional gathering function for the bacteria, anthrax also secretes two toxins, or poisons, known as lethal factor (LF) and edema factor (EF). These two toxins only work, however, when combined with a protein known as Protective Antigen (PA). A vaccine will be effective against anthrax if it confers a certain level of antibody response to the PA, thus inhibiting the expression of LF/EF. In other words, if the vaccine causes the immune system to create enough antibodies that will fight and overwhelm the Protective Antigen, it is considered effective.

    The anthrax vaccine is unique among vaccines in that there is no step in the manufacturing process for purifying the active fraction of the vaccine. The vaccine is made by growing a non-virulent strain of anthrax in a culture. This culture is filtered to remove the bacteria, but the remainder, including the proteins and enzymes, is absorbed onto aluminum oxyhydroxide. The antigens that are absorbed are then centrifuged out of the solution and, without being “washed”, are then resuspended into a saline solution with some preservatives. Because of the way in which the bacteria secretes enzymes and absorbs proteins, the vaccine is

    composed of an undefined crude culture of supernatant adsorbed to aluminum hydroxide. There has been no quantification of the protective antigen content of the vaccine or of any of the other constituents, so the degree of purity is unknown. Standardization is determined by an animal potency test.[iii]

    One would think that this statement must have come from an anthrax vaccine opponent, except that it is from an article authored by Colonel (Dr.) Arthur Friedlander, U.S. Army – as of 2004, the Chief Researcher at the U.S. Army’s Medical Research laboratory at Ft. Detrick, Maryland – and Dr. Philip Brachman, head of the original study on the previous Merck Pharmaceuticals-manufactured anthrax vaccine. As Dr. Friedlander notes, the antibody titer – the level of antibodies produced by the body in response to the vaccine, measured by a blood test – varies widely from lot to lot of the vaccine and is measured by injecting guinea pigs and measuring antibody response. This variety is due, in part, because the manufacturing process, developed in the 1960s, is antiquated by modern microbiology standards, which now control how a vaccine is judged for licensing purposes. All of this means that even under ideal conditions, the vaccine is likely to produce significant differences in potency from batch to batch. The problem with the AVA is that it has never been manufactured under anything even approaching ideal conditions.

    At the same time that the original Brachman study’s results were being published in 1954, the development of the anthrax vaccine continued apace. Interestingly, the vaccine used in the Brachman study was originally made by Merck Pharmaceutical, but it was changed in both content and production method by a new manufacturer, the Michigan Department of Public Health. This changed vaccine, not the original one used in the Brachman study, was what was patented by the U.S. Army in 1965.[iv]

    In 1967, an application was submitted to the National Institute of Health’s Division of Biologics Standards to get a license for the patented vaccine. A study was conducted at a Talladega mill using the newly-patented vaccine: but this study’s results have never been published. There was correspondence between the NIH and the head of the Talladega study indicating that there were problems with the methodology. Dr. Philip Coleman, the head investigator, wrote candidly to the NIH: “As to the efficacy of the vaccine, we have no real method of determining the protection afforded.”[v] There were also memos exchanged regarding the scientific validity of the Talladega study. An ad hoc licensing oversight committee sent a memo to a Dr. Margaret Pittman of the Department of Health Education and Welfare (HEW), the forerunner to the Dept. of Health and Human Services (DHHS), pointing out that “[t]he lack of cases of anthrax in an uncontrolled population of approximately 600 persons in the Talladega mill can hardly be accepted as scientific evidence for efficacy of the vaccine.”[vi] Notwithstanding these problems, Doctor Pittman recommended licensure of the vaccine on February 10, 1969, while acknowledging that “clinical data establishing efficacy of the product had not been submitted and that data be requested from NCDC (National Communicable Disease Center).”[vii] Efficacy data was a prerequisite to licensure by the 1962 Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act, previously detailed in Chapter 5.[1]

    On November 2, 1970, the license for the anthrax vaccine was recommended for approval by HEW without any of the required efficacy data. [viii] The License was granted on 10 November 1970. In an interesting twist, the efficacy data from the earlier Brachman Study was substituted, submitted, and accepted (yet no documentation of this submission has been uncovered). The Brachman Study is actually referenced on the approved package insert, even though the vaccine used in the Brachman Study differed from the licensed vaccine in strain, formulation, and production method. While there are those who will argue (and DoD representatives have before Congress) that the vaccines are sufficiently similar to allow conclusions to be drawn, that is a scientific debate. As a legal matter, it holds no weight. There is absolutely no way today, under the existing regulatory-licensing framework, that a company could get a license for a drug from the FDA by substituting a study from some other company’s drug, made by a different production method, using a different strain of bacteria, from a study done decades before. As one former FDA official who worked in the Department at that time sheepishly admitted, “these were the days when we were trying to help the industry.”[ix]

    When the Department of Biologics Standards was transferred under the FDA in 1973, a review began of all previously licensed vaccines that had not been required to show the necessary efficacy data. The anthrax vaccine would not undergo the necessary review for efficacy data until 12 years later, in 1985. During this review, the FDA concluded that “safety of this product is not a major concern, especially considering its very limited distribution…”[x] The committee also noted that “[a]nthrax vaccine poses no serious special problems other than the fact that its efficacy against inhalation anthrax is not well documented.”[xi] Finally, the Panel concluded that “there is sufficient evidence to conclude that anthrax vaccine is safe and effective under the limited circumstances for which this vaccine is employed.”[xii]

    During the Anthrax Vaccine Immunization Program (AVIP) rollout, the DoD publicly long claimed that “the vaccine has ‘an impressive safety record’” and that “it has been widely used for thirty years,” but neither of those statements can be squared with the 1985 review, which resulted in a proposed rule that was never been acted upon.[xiii] The 1985 review noted that “[i]mmunization with this vaccine is indicated only for certain occupational groups with risk of uncontrollable or unavoidable exposure to the organism. It is recommended for individuals who come in contact with imported animal hides, furs, wool, hair (especially goat hair), bristles, and bone meal, as well as laboratory workers involved in ongoing studies on the organism”[xiv] The license was granted in 1970, but the vaccine was not widely distributed nor widely used, given the narrow slice of the population involved in animal hide handling. In fact, in November of 1971, the Division of Biologics Standards of the National Institutes of Health, noting an apparent increase in reports of adverse reactions after individuals received booster shots, published guidance on the vaccine’s shot regimen.

    The Division considered it advisable to reevaluate the need for annual boosters and possibly the amount of the booster dose . . . Although the record is unclear as to whether or not the Division requested the manufacturer to conduct a reevaluation, no such reevaluation has been done to date.[xv]

    Part of the problem may stem from the vaccine’s shot regimen, which consists of the first three shots given within 2 weeks of each other, and then another 3 shots spread out over the remainder of a year, for a total of 6 shots to complete the series, with annual boosters thereafter.

    The DoD’s media campaign, though, rising to over $70 million dollars spent for a website and other educational information for the troops, includes literature that says the anthrax vaccine “has been safely and routinely administered in the United States to veterinarians, laboratory workers, and livestock handlers for more than 25 years.”[xvi] An April 2000 Congressional House report noted, however, that “testimony at the March 24 hearing indicated between 100 and 300 civilians may receive the vaccine each year. Since approval, and prior to the AVIP, fewer than 68,000 doses had been distributed apart from stocks used in Operation Desert Storm.”[xvii] Shortly after the vaccine was licensed, the mills began closing as the garment industry changed. The risk of exposure and infection from anthrax spores by the general public disappeared. The vaccine’s use became limited to experiments on laboratory animals, the researchers conducting the experiments, and the staff at the manufacturing plant. Proof of this is that from its licensing until 1988, when the DoD sought to increase the production lines for it, only 68,000 doses of the vaccine had been produced by MDPH and MDPH had never made a lot of more than 7500 doses at one time. If vaccination consists of six shots plus annual boosters, the number of possible persons inoculated is so small as to not even be statistically significant for long-term epidemiological studies. The 1985 Panel noted that “[t]he vaccine manufactured by the Michigan Department of Public Health has not been employed in a controlled field trial.”[xviii]

    Finally, there was never any effort to track long-term health effects from those who received the vaccine. There was no database maintained or other central records kept to track an individual’s long-term reactions to the vaccine. The Institute of Medicine conducted a review of all available literature and concluded that “[t]here is a paucity of published peer-reviewed literature on the safety of the anthrax vaccine.”[xix] It also noted that “[t]here have been no studies of the anthrax vaccine in which the long-term health outcomes have been systematically evaluated with active surveillance.”[xx] At no time in the history of the anthrax vaccine did their exist, or has their existed, support for the DoD’s claims of “an impressive safety record.” In truth, the DoD’s claims are particularly hollow and appear to be part of a campaign of disinformation. As a Congressional Committee noted in April 2000, “[p]reposterously low adverse report rates generated by DOD point to a program far more concerned with public relations than effective force protection or the practice of medicine.”

    The vaccine’s licensed product insert expresses an expected systemic adverse reaction rate of 0.2 %. In May, 1999, the Department of Defense reported a total of 123 Vaccine Adverse Events Report System (VAERS) filings with the FDA, but included only 65 of those in the calculation of an adverse reaction rate of 0.007 percent of 890,888 vaccinations given to that date. This means one of two things: either the vaccine is more safe than the product label indicates by a factor of 100, or the data is being underreported. Under pressure to conduct at least some studies, the DoD has done so and those studies have suggested much higher adverse reaction rates than the PR claims. In a study at Tripler Army Hospital, Hawaii, the data showed that 2.2% of men missed one or more shifts of duty after the first shot, 2.0% after the second, and .9% after the third. For women, the numbers were higher, consistent with other studies conducted. Women in the Tripler study indicated rates of 5.5%, 5.0%, and 3.9% for the first second and third shots, respectively.[xxi] A study on soldiers in Korea on systemic reactions also revealed significantly higher adverse reaction rates. Men and women were surveyed regarding symptoms of fever, malaise, and chills. In each of these categories, the numbers reflect numbers that are in some cases 1000 times higher than what DoD has testified to before Congress or stated in press releases. The Korea study’s numbers for men and women after the first shot are:

    Fever – 0.9 % men, 2.8% women; Malaise – 6.0% men, 15.6% women; Chills – 1.5% men, 5.5% women. Second shot systemic reaction rates are similar or higher.[xxii]  What is disturbing about these numbers is not the adverse report rates themselves; the most disturbing thing is that DoD had similar numbers from a survey taken of soldiers inoculated from 1977-1996 at Fort Detrick, Maryland.[xxiii] This means that the DoD has had similar adverse reaction rates the whole time it has been claiming publicly that the vaccine has the “preposterously low” rates that they have been reporting. Completely provable lies.

    The problems with the anthrax vaccine are not mere quibbling, but rather raise significant questions about how this vaccine is made, its component parts, and the actual lots that are currently sitting on the shelf at the manufacturer’s facility, ready to be shipped or already shipped to the DoD for use on service members.[2]

    Endnotes

    [1] See Chapter 5, pp. 48-50.

    [2] I would remiss if I did not give credit to the research conducted by Major Russ Dingle, USAFR, whose knowledge about the anthrax vaccine manufacturing process is encyclopedic in its breadth and depth. Any errors are entirely mine.

    [i] Wright, GG. Et al. Studies on Immunity in Anthrax. The Journal of Immunology. Vol. 73 No. 6 pp387-391

    [ii] Brachman. P.S. et al. Field Evaluation of a Human Anthrax Vaccine. American Journal of Public Health. Vol. 52 pp. 632-645

    [iii] A.M Friedlander and P.S. Brachman, “Vaccines”, ed. Plotkin and Mortimer, 1994 edition chapter 26, pg. 737.

    [iv] Pubis, M. Wright, GG. Anaerobic Process for Production of a Gel-adsorbed Anthrax Immunization Antigen. United States Patent Office Record. September 28, 1965. page 1471

    [v] Philip Coleman, Acting Chief, Investigational Vaccines Activity , letter to Division of Biologics Standards, National Institutes of Health, 25 January 1968.

    [vi] Ad Hoc Committee letter to Dr. Margaret Pittman, 6 February 1969.

    [vii] Dr. Margaret Pittman, letter to Dr. Sam Gibson, 10 February 1969.

    [viii] HEW memorandum from Margaret Pittman to Reference No. file 67-70. 2 November 1970.

    [ix] Conversation with Mr. Sammie Young, former Director of Biologics Division of the FDA.

    [x] 21 C.F.R. 51002, 51008

    [xi] Id.

    [xii] Id.

    [xiii] DoD Press Briefing, Dec. 5, 1997.  Available at http://www.defenselink.mil/news/  then follow links to 1997 archives.

    [xiv] 21 C.F.R. 51002, 51008

    [xv] GAO Report T-NSIAD-00-48, Testimony of Dr. Kwai-Cheung Chan, Director, Special Studies and Evaluations, National Security and International Affairs Division

    [xvi] See note xii.

    [xvii] April 2000 Shays’ report, citing Prepared statement of Dr. Kathryn Zoon, Director, FDA Center for Biologics Evaluation and Research, NSVAIR anthrax hearing (II), pp. 52-53.

    [xviii] 21 CFR 51002, 51008

    [xix] “An Assessment of the Safety of the Anthrax Vaccine”, A Letter Report, Committee on Health Effects Associated with Exposures During the Gulf War, Institute of Medicine, 30 Mar 2000

    [xx] Id.

    [xxi] GAO Report, T00-48, Table 3.

    [xxii] GAO Report T00-48, Table 2.

    [xxiii] See GAO Report T-NSIAD-99-226, July 21, 1999.  Table below shows the results of Ft. Detrick study.

    Dose number Males percent (# of doses) Females % (# of doses)
    First 3.75 (1013) 3.86 (259)
    Second 3.06 (979) 7.29 (247)
    Third 1.71 (938) 5.06 (237)
    Fourth & Later 3.40 (5062) 7.06 (747)

     

  • 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 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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