Category: Military

  • Profiles in Toxic Masculinity VII: Mad Jack Churchill

    Profiles in Toxic Masculinity, Part 7

    Appearances Can Be Deceiving

    The fellow to the right is a respectable-looking chap, isn’t he?  Maybe a bit stern, but all in all, a good steady sort; the kind you’d find running a major business enterprise or maybe a bank; a solid, reliable type, not the kind of man who would attempt anything wild or risky.

    That assessment couldn’t be more off base.  Who that gentleman is, is no less than John Malcolm Thorpe Fleming “Mad Jack” Churchill, a man who went into battle with a sword, a revolver, a longbow and bagpipes.  He was one of the ballsiest men to ever draw breath, and thus richly deserving of this week’s Profile in Toxic Masculinity.

    His Maculate Origin

    Jack Churchill was born on September 16, 1906, in Colombo, British Ceylon, to Alec Fleming Churchill later of Hove, East Sussex and Elinor Elizabeth, daughter of John Alexander Bond Bell, of Kelnahard, County Cavan, Ireland, and of Dimbula, Ceylon.  There was no family connection to another famous example of toxic masculinity who shared the last name of Churchill, although the two men were contemporaries.  When young Jack was only four, the family moved to Hong Kong.  Seven years later, in the thick of the Great War, the Churchills returned to England, settling in Surrey.

    Determined to pursue his education in the most masculine setting possible, Jack Churchill determined he would attend university at King William’s College on the Isle of Man.

    That’s right – the Isle of Man.

    Jack went on to the Royal Military College at Sandhurst and on his graduation in 1926, rode off to serve as an infantry officer in the Manchester Regiment in Burma.

    His Adventurous Career

    Being in an infantry regiment with a long and storied history wasn’t enough to keep the young Churchill entertained.  To remedy this, he bought a motorcycle and spent his spare hours careering around Burma, on main roads, side roads, dirt tracks, or wherever else struck his fancy.  He was already a crack shot with rifle and revolver as well as the English longbow, which was to serve him well in years to come.

    In between motorcycle trips and military maneuvers, he taught himself how to play bagpipes, because why not?

    Leaving the Army in 1936, Jack headed for Kenya, where he worked as a newspaper editor.  Because editing a colonial newspaper wasn’t enough, the young Churchill embarked on a brief film career.  He had already parlayed his archery and bagpipe proficiency into a small part in 1924’s The Thief of Bagdad, and he expanded on that by appearing in A Yank at Oxford in 1938.

    He also represented Britain in the 1939 World Archery Championships in Oslo.

    But events that unfolded in 1940 were to deliver to this stalwart combination of Rob Roy, Robin Hood and a Terminator the best opportunities yet to (figuratively) show off his enormous adamantine pair of cojones.

    His One-Man War

    Even when he’s seated at a desk, that glare increases pucker factor by 122.5%.

    When Germany invaded Poland in 1939, Churchill rejoined his regiment.  The Manchester Regiment was assigned to the British Expeditionary Force in France, which was in the process of having its ass kicked all the way to the English Channel by the German blitzkrieg.  Churchill, of course, was having none of that “retreat” nonsense and resisted at every turn.  One on occasion Churchill led a small group of Brit soldiers into ambushing a German patrol near the French town of L’Épinette.

    After letting the Krauts get in good and close, Churchill gave the order to attack by brandishing his claymore, chucking a grenade and bellowing “CHARGE!”  The Brits charged, led by the possibly mad Churchill and his broadsword, and routed the German patrol.  When asked later by a higher-ranking officer why he insisted on carrying the Scottish sword, Churchill replied “In my opinion, sir, any officer who goes into action without his sword is improperly dressed.”

    Incidentally it was this action that began the rumor of Churchill’s having killed a German with a longbow, hence becoming the only Allied solider in WW2 to do so, but Churchill himself denied that claim, noting that his longbow had been crushed underneath a lorry some time before this incident.

    He went on going into battle properly dressed, leading his men on a series of rear-guard and guerilla actions against the Germans until the BEF was evacuated at Dunkirk.  He was wounded in the neck by a machine-gun bullet but refused evacuation and went on fighting.

    At this point he decided that the ongoing unpleasantness would offer more opportunities to kill Germans if he joined a unit even more elite than the Manchester Regiment, so he volunteered for the Commandos, eventually becoming second-in-command of No. 3 Commando.

    An exercise, not the real raid, but still a maniacal badass with a sword leading the way.

    In 1941 No. 3 Commando, including the now Lieutenant-Colonel Churchill, took part in Operation Archery.  In this action, on December 27, 1941, in a daytime amphibious landing, the No. 3 Commando raided a German garrison at Vågsøy, Norway.  Lieutenant-Colonel Churchill was on the first landing craft.  When the ramp dropped, he was the first off, and promptly scared the living bejeezus out of the Germans by standing in the surf playing March of the Cameron Men on his bagpipes as the rest of the Commando stormed ashore.  When all were present, Churchill chucked a grenade at the German positions, apparently his favorite way to begin an attack, and drew his sword, leading the Commando into battle.  After the action was awarded the Military Cross with Bar for conspicuous gallantry, and likely also because the British Army didn’t dare fail to award a man with Churchill’s combination of courage and insanity.

    1943 found Colonel Churchill in command of No. 2 Commando.  That unit landed and fought in Sicily and Salerno.  In that second action, Churchill was ordered to silence a mortar position and eliminate a German observation post that controlled a pass overlooking the Salerno beachhead.  Most officers would have assembled a patrol and moved on the positions with fire and maneuver in a traditional infantry operation, but not Jack Churchill.  He led No. 2 Commando to encircle the German observation post, then drew his sword, brandished it, bellowed “COMMANDO!” and charged the post, easily taking it and killing or capturing the German troops.  He then went on to take out the mortar post by capturing one guard, then moving on to the others in turn, shoving his Scottish sword in their faces and demanding their surrender.  He later commented:   “I maintain that, as long as you tell a German loudly and clearly what to do, if you are senior to him he will cry ‘jawohl’ (yes sir) and get on with it enthusiastically and efficiently whatever the situation.”

    In 1944, his luck ran out, but his courage didn’t fail him.  Churchill was leading Commandos in Yugoslavia in support of Marshall Tito’s partisans.  In May of 1944 he was ordered to raid the German-held island of Brač.  Despite having assembled a considerable force of 1500 partisans and 44 Brit Commandos, the attack was unsuccessful.  On the second morning of the mission, Churchill led a flanking attack on the German positions while the Partisans remained behind.  By the time the Commandos reached the objective only six were left alive, of which Churchill, still toting a rifle along with his sword and bagpipes, was one.  Mortar fire swept their positions, killing all remaining members but Churchill.  Out of grenades and ammo as the Germans closed in, he stood and began playing Will Ye No Come Again on his bagpipes until a grenade knocked him unconscious.

    The Germans, noting the name on this identity disk and incorrectly assuming a family connection to the British Prime Minister, sent him to Berlin.  There he was interrogated until, in frustration of having learned nothing from the stalwart officer, the Germans sent him to the Sachsenhausen concentration camp near Oranienburg, Germany.

    By September 1944 Mad Jack had enough of a prisoner’s life.  Enlisting a Royal Air Force officer, Bertram James, to help in the attempt, he and James crawled under the wire around the camp and into an abandoned drainpipe.  Making their way away from the camp, they headed for the Baltic coast but were recaptured only a few miles from the sea.

    Mad Jack in Action.

    Probably because of his predilection for escaping and also probably because he intimidated the shit out his Wehrmacht guards, in April of 1945 Churchill was sent to an SS-run concentration camp near Tyrol.  After a delegation of Allied prisoners complained to a passing Wehrmacht officer, one Hauptmann (Captain) Wichard von Alvenslaben,  that they were worried about being murdered by the SS, the German captain (perhaps looking ahead to the consequences of Germany’s looming defeat) surrounded the camp and “advised” the SS to get the hell out.  They did so, and soon after the German regulars did as well.  Churchill and some others promptly decamped and walked 90 miles to Verona, Italy, where they found an American armor unit.  On rejoining Allied forces in this manner, Churchill was disappointed to find the Germans had surrendered, and so wasted no time demanding reassignment to Burma, where the Japanese were still kicking up their heels.

    The assignment was granted, but by the time Churchill made his triumphant return to Burma, Hiroshima and Nagasaki had both been wiped off the map.  The Japanese Emperor, realizing that the tide of battle had irreversibly turned against Japan now that Mad Jack Churchill was in the theater of operations, surrendered.

    Churchill was miffed, to say the least, complaining that “…. if it weren’t for those damn Yanks, we could have kept this war going another ten years!

    After the war Churchill continued to demonstrate badassery of a kind not much seen in British men today.  He qualified as a paratrooper and was assigned to the Seaforth Highlanders in Palestine, where he performed such feats as assisting a medical convoy under attack by Arab partisans.

    In 1952 he resumed his film career, appearing alongside Robert Taylor in MGM’s production of Ivanhoe.

    Churchill retired from the British Army in 1959, but he wasn’t done yet; not by a long shot.

    His Golden Years

    On retirement, Churchill went home to Sussex with his wife, Rosamund Margaret Churchill nee Denny, and their children, Malcolm Leslie and Rodney Alistair.  He hung his Army awards up, and they made quite a list:

    • Distinguished Service Order with bar
    • Military Cross with bar
    • 1939-1945 Star
    • Italy Star
    • Burma Star
    • War Medal 1939-1945
    • General Service Medal with “Palestine 1945-1948” bar

    His eccentricity continued.  He went on bagpiping and longbowing his way through life. Even in retirement he maintained an office and, in the afternoons on his return home, startled train passengers by hurling his briefcase out of the train window some ways before his stop.  When someone finally worked up the nerve to ask why, he calmly explained that he was chucking the thing into his back garden so he wouldn’t have to carry it home from the station.

    John Malcolm Thorpe Fleming Churchill died on March 8th, 1996, at 89 years of age, in Sussex.  The Royal Norwegian Explorers Club named him as “one of the finest explorers and adventurers of all time,” and to this day, he has yet to be outmatched in that regard.  His legacy remains today as one of the toughest, most fearless, possibly craziest soldiers Britain has ever produced; a legacy that almost certainly would have pleased him.

  • 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 10 – The Anthrax Vaccine Fails, Is Awarded Zero Points… and you’ll still have to roll up your sleeve!

    The manufacturing process for Anthrax Vaccine is not validated.[i]

    The anthrax vaccine’s manufacturer has had an interesting ownership history, beginning in 1968 as the Michigan Department of Public Health (MDPH), a public entity that manufactured the earliest vaccine through 1997, when it spun off its ‘biologics’ division into a for-profit entity, the Michigan Biologic Products Institute (MBPI), BioPort, Inc. quickly bought MBPI in 1998. While management and ownership structure changed, one thing has remained remarkably consistent: how badly the vaccine has been manufactured from when it first began being inspected. BioPort/MBPI/MDPH has continued to violate the regulations governing the manufacture of the vaccine and current Good Manufacturing Practices (cGMP) for as long as it has records of inspections. The regulations regarding the manufacture of biologic products is fairly tedious, but the underlying philosophy can best be summarized by the first pull-quote above: the manufacturing process for the anthrax vaccine is not validated.

    Because Anthrax Vaccine Adsorbed (AVA) is a biologic product designed for human consumption, it is controlled by very stringent requirements. A GAO report pointed this out and explained the necessity for it:

    The inspection process for ensuring vaccine safety is more stringent and complex than for chemical drug because vaccines have three distinguishing features. First, either they have no clearly chemically defined composition, or chemical analysis is extremely difficult. Second, proper evaluation of vaccines generally requires measuring their effects in animals. Finally, quality cannot be guaranteed from final tests on random samples but only from a combination of in-process tests, end-product tests, and strict controls of the entire manufacturing process.[ii]

    Biologic products are regulated by the Public Health Service Act (PHS) and the Federal Food, Drug, and Cosmetic Act (FDCA). 42 U.S. Code §262 describes the regulation of biologic products according to the PHS Act. Chapter 9 of Title 21 of the U.S. Code contains the FDCA.

    The FDCA provides the following definition of an adulterated drug:

    A drug shall be deemed to adulterated (a)(1) (A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.[iii]

    Thus, in sum, a drug is adulterated if it is either (a) made under “insanitary conditions” or, (b) if the manufacturer does not comport with current Good Manufacturing Practices (cGMPs). The Code of Federal Regulations, specifically 21 C.F.R. §600 and following, sets forth the current Good Manufacturing Practices for Biologic products. 21 C.F.R. §601.12 reads, in part:

    (a) General. As provided by this section, an applicant shall inform Food and Drug Administration (FDA) about each change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling, established in the approved license. Before distributing a product made using a change, an applicant shall demonstrate through appropriate validation and/or other clinical and/or non-clinical laboratory studies, the lack of adverse effect of the change on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.

    (b) Changes requiring supplemental submission and approval prior to distribution of the product made using the change (major changes). (1) A supplement shall be submitted for any change in the product, production process, quality controls, equipment, facilities, or responsible personnel that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety and effectiveness of the product. (2) These changes include but are not limited to: (i) Changes in the qualitative or quantitative formulation or other specifications as provided in the approved application or in the regulations; (vi) Changes which may affect product sterility assurance, such as changes in product or component sterilization method(s), or an addition, deletion or substitution of steps in a aseptic processing operation.

    Until a 1988 contract with the DoD, the production of Anthrax Vaccine Adsorbed (AVA) was infrequent, a batch being produced every three to four years, with the largest being 7500 doses. MDPH had one production line for AVA that they alternately used for other vaccine products. The 1988 contract with DoD called for a drastic increase in the amount of production of the anthrax vaccine: 300,000 doses over a five-year period. The only possible way to meet the requirements of the DoD contract was to increase the production facility itself. One production line would simply not meet the demands of that new contract.

    The first production line, and only one licensed by the FDA, was built around a 100-liter sintered glass-lined fermenter, where the anthrax bacteria was cultured and grown. In 1990, two new stainless-steel fermenters were added to grow the bacteria. In 1991, the original, licensed glass-lined fermenter was removed and two more new stainless-steel fermenters were added, bringing the number of production lines to four.

    None of the new fermentors were approved by the FDA prior to being installed and beginning to produce the anthrax vaccine. This was not news to anyone; MDPH was aware of the need for prior FDA approval. Documents show that Dr. Robert Myers, the Responsible Head of MDPH, was well-briefed in the FDA requirements for amending the Establishment License Agreement (ELA). Dr. Myers notified the Center for Biologics Evaluation and Research (CBER) in June 1990 that BioPort would replace the approved fermenter and chill tank on or about 15 August 1990 with a new fermenter. A 9 July 1990 Conversation Record by FDA employee Rebecca Devine to Dr. Myers indicates that he was informed that this would be considered a major change and should be submitted in the form of an ELA amendment. An FDA official also communicated to Dr. Myers that the new equipment was considered a “major change” to the facility’s Establishment License Agreement (ELA) in December 1990.[iv]

    MDPH applied for the necessary amendment to the ELA in December 1990 for the first two new fermenters installed in that same year.[v] This ELA amendment request indicates, however, that the renovation had already taken place. Additionally, the two production lines added in 1990 consisted of stainless-steel fermenters, stainless-steel chill tanks, and low-protein-binding nylon membrane filters, while the production line in the original ELA consisted of glass-lined fermenters, a glass-lined chill tank, and sintered-glass filters. The 1990 ELA amendment request, while indicating that stainless-steel equipment was being used, failed to identify this as a change in equipment type for the additional production lines. As a result, the FDA was unaware of the substantial likelihood of the amendment request to have an adverse effect on the “identity, strength, quality, purity, or potency of the product as they may relate to the safety and effectiveness of the product.” Finally, the FDA did not approve these fermenters in 1993.[vi] No amendment was ever sought for the subsequent two stainless steel fermenters, nor was there ever an amendment made to the Product License Amendment for this change in how the cultured bacteria was being grown.

    More troubling is that a July 1990 Trip Report to the Michigan facility by a member of the U.S. Army Medical Research and Development Command (USAMRD) indicates that at least one 100-liter fermenter had been added to the AVA production line and that a recently delivered 100-liter fermenter could be diverted from production of another vaccine to the AVA production line. A September 1990 Trip Report to the Michigan facility discusses the necessity and the ability to put the recently acquired additional fermenter into AVA production. Also discussed is the total number of fermenters that the facility could hold, i.e. three additional fermenters for a total of four fermenters producing AVA. This Trip Report also indicates that FDA must approve the change in fermenter types from glass-lined to stainless steel and that FDA approval will require developing the definitive data that the product from the stainless steel fermenters is the same as the glass-lined fermenters.

    It also bears noting that each of the production lines did not produce individual lots of the vaccine. After 1990, while the old (licensed) line was running, alongside the  two new stainless-steel lines, each production line’s output was stored as a sublot and then combined for shipment to form what was labeled as the “final anthrax vaccine” lot (FAV-001, FAV-002, etc.). The stainless steel sublots supposedly produced a more potent vaccine. As a result, MDPH delivered a least one dose of AVA to DoD that was produced after the major manufacturing change had occurred and before the ELA amendment was approved.

    As if all of the above-listed, unapproved changes were not enough, MDPH changed the type of filter used in the manufacturing process. This filter is the only part of the manufacturing process that purifies the vaccine. There were no amendments sought to either the ELA or the PLA. This means that all of the anthrax vaccine produced from these lines was and is, by definition, adulterated. Every dose delivered since the 1990 manufacturing change has occurred without an ELA amendment for the change in filter type. Lest this appear to be scientific or legal quibbling, when the FDA conducted inspections through 1995, this specific filter would fail inspection.

    The FDA inspectors conducted numerous inspections of the anthrax production facility over some 7 or 8 years. During this time, the inspectors would cite repeated and serious problems with the manufacturing process. Below is a bulleted list of some of the major findings.

    1988.[vii]

    • “There is no written procedure for assessing stability characteristics of final biological products.”
    • “No direct physical accountability for packaged undated anthrax vaccine which was stored alongside of packaged and dated vaccine with the same lot number. Nine hundred and six vials of unfinished vaccine were distributed freely in 3 cardboard boxes with unknown number of vials in each carton. Removal of vials as needed was not indicated.”

    1990.[viii]

    • “Anthrax prod. fac. was observed to be in a state of general disrepair in that there was: (A) Paint peeling from the walls (B) Exposed light fixtures (C) Cracked ceiling (D) Exposed raceways (E) Dirt & filth & dust on overhead pipes (F) Cluttered work space.”
    • “Anthrax prod. records are inconsistent in that procedures used to formulate Lot #21 are different from those used to formulate Lots #25, 26 & 27 in that media is autoclaved for sterilization for Lot #21 and filtered for sterilization for Lots #25, 26 & 27.”

    1992.[ix]

    • “Changes in the manufacturing methods for…were not submitted as amendments to the product license application prior to releasing the material for distribution…”
    • “No SOP [standard operating procedure] exists to describe procedures for handling potentially infectious material…”

    1993.[x]

    • “There are insufficient personnel to assure compliance with current GMP regulations, e.g., failure to report changes in manufacturing, failure to maintain calibration records adequately, failure to adequately validate equipment used in the formulation or testing of product.”

    1994.[xi]

    • “There are insufficient personnel to assure compliance with current GMP regulations, e.g., failure to maintain calibration records adequately, failure to maintain environmental controls adequately in that production area temperatures were above 80°F, and failure to submit changes to CBER.”
    • “There is no annual review of production batch records [anthrax].”
    • “Raw material [anthrax vaccine materials] stored in an unapproved warehouse, building (redacted) i.e., no ELA [establishment license application] supplement has been submitted for this area.”

    1995.[xii]

    • “the company did not inform FDA of the procedural and equipment change during the production of…”
    • “facilities and equipment were not adequate.”
    • “SOP’s did not exist for many procedures.”
    • “SOP’s were incomplete or incorrect.”
    • “SOP’s were not adhered to.”
    • Frequent contamination during vaccine manufacturing was documented but not investigated.

    Finally, on June 22, 1995, the CBER Inspection Task Force recommended the issuance of a Warning Letter to MDPH. Another Warning Letter was issued to MDPH on 31 August 1995. Subsequent inspections found that the warning had no effect on the quality of the product being produced.

    1996.[xiii]

    • “The firm had not completed cleaning validation studies for routine cleaning procedures on multi-use equipment.”
    • “Validation studies to demonstrate microbial retention and compatibility have not been conducted for sterilizing filters…”
    • There was condensate dripping onto open (redacted) tanks…
    • “There was no procedure for clean-up of live rabies virus spills…”
    • The anthrax production facility was not inspected because “it comes under military inspection.”[xiv]

    In 1997, after some ten years of continuous violations of CGMPs, CBER issued a “Notice of Intent to Revoke” the license of MBPI.[xv] The Army responded by sending in a team to assist the manufacturer develop a “strategic compliance plan.” In January 1998, anticipating another inspection by the FDA, MBPI decided to “voluntarily” shut down its production.[xvi] An FDA inspection in February returned a report which concluded:

    “The manufacturing process for Anthrax Vaccine is not validated.”

    The report also noted that “[t]here are no written procedures, including specifications, for the examination, rejection, and disposition of Anthrax and Rabies.”  And, finally, what should have been reported seven years earlier: “Prior to August 1997, the (redacted) filters used for harvest of Anthrax vaccine were neither validated nor integrity tested. This filter is the only sterile filtration step in the Anthrax manufacturing process.” An inspector “questioned W. White, D. Slabbekoorn, and T. Wilsey regarding the filters used prior to this validation. Each reported that the filters used prior to the introduction of the [redacted] filters had not been integrity validated nor were they routinely integrity tested.” The filters were approved in August 1997, however, a February 1998 inspection revealed that the validation process used to gain the approval was not valid. Incredibly, the validation for the filters was not done using the anthrax vaccine. “Validation of microbial retention by the (redacted) filters used for harvest of Anthrax vaccine was performed only with (redacted) media, which is used in tetanus production. Studies were not performed using Anthrax product or media.” This means that there had been no test done to determine if the filters would even work to filter out the necessary impurities in the anthrax vaccine, but instead had been done on the tetanus vaccine.

    Another finding was that “[t]he firm does not trend multiple contaminations with microorganisms in sublots.” As a result of this February inspection, MBPI “voluntarily” quarantined 11 lots of AVA. The failure of FDA to recall the quarantined vaccine and order it destroyed resulted in some of it being shipped to the Canadian military and being used on their servicemembers.[xvii] The list of violations, unfortunately, does not end here.  Another inspection took place in October 1998, finding:[xviii]

    • “Stability testing has not always been performed in accordance with stability protocols, for example…”
    • “CBER has not been notified in accordance with Error and Accident reporting of the following…
    • “On 6/30/98, the firm installed a new reaction tank mixer on Tank (redacted). There is no data documenting that the new mixer is equivalent to the old mixer, including mixing profiles. In addition, CBER has not been notified of this change.”

    Yet again, in 1999, the FDA found that “[t]he manufacturing process for Anthrax Vaccine Adsorbed is not validated.”[xix]

    Thirty observations were noted. The inspection report ends with this comment. “The observations noted in this FDA-483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and all violations of the GMP regulation.” What is unique about these findings is not that they are out of the past trend-line of the manufacturer, but these were found at the new facility! The old facility had been razed in 1998 and a new one built in an extraordinary windfall from the U.S. taxpayers approved by the DoD, which will be discussed in some detail later. Despite all of this, in 2000:[xx]

    • “The design and construction…do not assure sterility of products filled…”
    • “The following product lots failed initial sterility testing for release or for stability testing…Investigations into these initial sterility failures are incomplete…”
    • “Investigations are incomplete, inaccurate, or not conducted.”
    • “There is no assurance equipment is operating as designed.”

    In addition to these violations in manufacture, there were also significant problems in what happened to the vaccine after it was made. A product can be adulterated even after it is manufactured correctly (which didn’t happen in this case) if it is “prepared, packed, or held under insanitary conditions”. The regulations regarding processing also apply to packing and holding. Thus, “[t]he failure to comply with any regulation set forth in this part and in parts 211 through 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action.”[xxi]

    Biologic products also have expiration dates as described in Part 600 of 21 C.F.R. Modifications to the expiration dates “shall be made only upon written approval, in the form of a supplement [amendment] of the product license, issued by the Director of the Center for Biologics Evaluation and Research.” Expiration dates are also regulated under the current good manufacturing practices. The reason for this is that biologic products by their very nature may break down chemically over time. In order to “assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in §211.166.” 21 C.F.R. § 211.166 states in part:

    There shall be a written stability testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expirations dates.

    In 1997, MBPI relabeled 1.5 million doses of AVA. That is, MBPI took vials of AVA that were already labeled with an expiration date and soaked the labels off. They then relabeled the vials with new expiration dates. These 1.5 million doses of AVA are adulterated for that reason alone. Also, at the time of the relabeling, MBPI had no approved stability testing program, as observed in the February 1998 FDA inspection.  They also had no approved procedures for removing and relabeling filled vials of vaccine. In other words, there was no certified process to guarantee that the originally labeled vials were the same ones when relabeled. In other words, MBPI could not assure that the vials would be re-identified correctly, i.e. FAV008, or FAV009, etc. Hopefully, whoever soaked the labels off, got the right number back on the right bottle.

    MBPI also “re-dated” bulk vaccine that had expired without justification or approved procedures. These doses, too are legally & scientifically “adulterated.” Both of these practices, relabeling and re-dating, require a supplement to the product license IAW 21 C.F.R. § 610.53(d). No supplement was sought or approved at the time of these events. Current good manufacturing practice regulations require compliance with these parts of the C.F.R. Non-compliance renders the drug adulterated.

    There is no other way to express the violations of FDA regulations by the manufacturer of the anthrax vaccine as anything other than laughably abhorrent. Two things make it worse: First, the FDA’s failure to police a manufacturer who is wantonly violating regulations designed to protect the health of U.S. citizens, and second, the DoD’s actions in light of these continued violations, of which it had full knowledge. The public actions of both of these agencies are almost too incredible to believe in light of what both knew was going on at the production facility, but they happened. Now that we’ve considered the manufactures actions, I turn first to the DoD’s actions and then to the FDA’s.

    Endnotes

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

    [ii] GAO Report T-NSIAD-00-48 (Oct. 12, 1999).

    [iii] 21 U.S.C. § 351 (2000)(emphasis added)

    [iv] Conversation record memo from Rebecca Devine to Dr. Myers, 9 July 1990.

    [v] MDPH letter to CBER seeking to amend establishment license for new equipment, 6 December 1990.

    [vi] CBER letter to MDPH granting approval of new equipment, 27 July 1993.

    [vii] FDA Form 483 Inspectional Observations, 26-27 April 1988.

    [viii] MDPH letter to CBER responding to FDA inspectional observations made on 12-13 September 1990, 10 October 1990.

    [ix] FDA Form 483 Inspectional Observations, 29-31 July 1992.

    [x] FDA Form 483 Inspectional Observations, 4-7 May 1993.

    [xi] FDA Form 483 Inspectional Observations, 31 May – 3 June 1994.

    [xii] FDA Form 483 Inspectional Observations, 23 April 1995 – 5 May 1995,

    [xiii] FDA Form 483 Inspectional Observations, 18-27 November 1996.

    [xiv] Summary of Findings Report, 14 January 1997.

    [xv] CBER NOIR letter to MBPI, 11 March 1997.

    [xvi] FDA Form 483 Inspectional Observations, 4-20 February 1998.

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

    [xviii] FDA Form 483 Inspectional Observations, 19-23 October 1998

    [xix] FDA Form 483 Inspectional Observations, 25-23 November 1999.

    [xx] FDA Form 483 Inspectional Observations, 10-26 October 2000.

    [xxi] 21 C.F.R. 210(b)

  • The Face of Battle – A Book Review

    On a long drive to an undisclosed location recently, I listened for the second time to British military historian John Keegan’s The Face of Battle, his first book for the more-or-less general public.  I first listened to it probably 15 years ago, so my recollection was pretty fuzzy.  I’ve listened over the years to many of his books, and never been disappointed.  I expect I will revisit all of them in time.

    One of the things I enjoy about John Keegan is the quality of his prose.  It is just wonderful –clear, nuanced, with a dry wit underneath it all.  Very Brit, the kind of writing that reminds you they invented the language.

    The book falls into five parts.  The first is easily skipped, as it is the most academic by far – an extended discussion of the history of battle literature, the various academic fads and literary approaches, etc.  The approach he adopts is to focus (to the extent he can) on what the soldier’s experience of the soldiering and the battle would have been.

    He then examines three battles:  Agincourt, Waterloo, and the Somme (really, the first day of the Somme).  His Brit-centricity shows in his selection of battles that Britain not only fought, but ultimately won (although the first day of the Somme was an archetypal defeat that struck very deeply into British society).

    The accounts of Agincourt and Waterloo are very illuminating, with the account of the Somme being something of a letdown.  In part, I suspect, because the fighting on the first day of the Somme was essentially decided, and not in the Brits’ favor, within the first half hour, although nobody had any idea what was actually happening until the day was over.  Also, the very simplistic tactics of the Brits (an artillery barrage that was both enormous and almost completely ineffective, and then men walk in line across no-man’s land) are quickly comprehended and just don’t carry the interest of the back-and-forth at both Agincourt and Waterloo.  Overall, though, he strikes a nice balance between giving a tactical overview of the fighting and a look at the experience of the common soldier and their officers.

    The final section  is a review of what we have seen and learned and an attempt to generalize.  He addresses two issues.

    The first is why men will actually fight in a battle, going beyond the usual “because their buddies are”.  Historically, desertion and abandonment were always very present (providing a counterpoint to the standard narrative), with harsh penalties and soldiers posted specifically to keep men facing the front (such as Wellington’s positioning of cavalry behind some units of foot soldiers).  At Agincourt and Waterloo, whole units left the battle by the simple expedient of hiding in nearby woods.  In a modern-day battlefield, he concludes, men fight because the battlefield is so huge and deadly that front-line soldiers can’t escape it, except by fighting their way through.

    The second question is whether modern warfare has made “traditional” pitched battles between large opposing armies a thing of the past.  This is where I would have really like to see a post-script, as his answer here bounded by the Cold War face-off in Europe (recall, the book was written in the mid-70s).  Between the insupportable demands on the fighting men of a battle between NATO and the Soviets, and of course the risk of nuclear war, he leans toward the conclusion that large scale battles may be a thing of the past.

    Of course, in the decades since there have been a series of battles, mostly in the Middle East.  I would have liked to read Keegan’s take on these.  Just because they tend to be mostly one-sided probably doesn’t mean they aren’t battles, but much of the fighting I think would not qualify as a battle (which is an interesting question of its own).  The Iraqi wars would have given him a chance to test his thesis that a modern battle could exceed the capacity of men to fight, given the intensity and the doctrine of continuous engagement over long periods of time.

  • Profiles in Toxic Masculinity VI: Roy Benavidez

    The young Raul Perez Benavidez.

    Profiles in Toxic Masculinity, Part 6

    Appearances Can Be Deceiving

    The young fellow to the right looks like nothing more than a young man from some time ago, a rash, devil-may-care young guy of a sort we’ve all encountered.  Probably a good kid to share a cold beer with; a young guy with little more on his mind than finding a job, buying a car, maybe finding a girl.

    What this young fellow became, though, is much more than that.  This is one of the few photos from the youth of Roy Benavidez, a great hero, a Medal of Honor awardee, and one of the Vietnam War’s most outstanding soldiers.  Say what you will about the Vietnam conflict, but any such scrap yields both villains and heroes; Roy Benavidez is absolutely one of the latter.

    His Maculate Origin

    Raul Perez “Roy” Benavidez was born on August 5th, 1935, near Cuero, Texas.  He was the son of Salvador Benavidez, a farmer, and Teresa Perez, a Yaqui Indian.  Young Roy’s life was not an easy one, as his father Salvador died when young Ro was only two; his mother remarried but also died five years later.  Benavidez lost both of his parents to a disease not often seen today:  Tuberculosis.  On the death of his mother, Benavidez and his younger brother moved to El Campo, Texas, to live with his grandfather and an aunt and uncle.

    The young Benavidez wasn’t one to shy away from work.  He did shy away from schooling, dropping out at age 15, but he was a worker; he shined shoes at the EL Campo bus station, worked on farms on the West Coast, and eventually returned to El Campo to work in a tire shop.  In 1952, he joined the Texas National Guard; in 1955, he joined the active Army as a medic.  It was this change that finally have the young man a career – and considerably more than that.

    His Adventurous Career

    PFC Benavidez.

    Not one to shy away from a challenge, the new soldier from El Campo volunteered for Airborne training and, on completing that, was assigned to the 82nd Airborne at Ft. Bragg, North Carolina.

    In 1965, Sergeant Benavidez was sent to South Vietnam.  There he was assigned, as many Special Forces types were in those days, as an adviser to the Army of the Republic of Vietnam – working with, as U.S. Forces called them, “Marvin the ARVN.”  His luck was not good; one day on a patrol, SGT Benavidez stepped on a mine.

    His injuries were severe.  Benavidez was evacuated to the Army’s Brooke Army Medical Center at Ft. Sam Houston, Texas, where doctors assured him he would never walk again, and began processing his discharge papers.  Sergeant Benavidez decided “f**k that” and decided, in typically tough Special Forces fashion, that he would not only walk again but would resume his Army career; through sheer force of will, he did so.

    Against doctor’s orders, the determined NCO would crawl out of bed after lights out each night.  Dragging himself with his elbows and chin to a wall, he would leverage himself upright, a little further each night, pushing through pain that he admitted left him in tears but was preferable to not walking.  He eventually stood, then walked.  In July 1966, he walked out of the hospital and, despite continual pain from his barely healed wounds, volunteered to return to Vietnam.  Pain from old wounds notwithstanding, Sergeant Benavidez took his career to the next level and volunteered for Special Forces training, which he completed successfully; on his assignment to the 5th Special Operations Group, he sought and was granted assignment to the elite Studies and Observations Group.  In January 1968, his long sought-after orders came through, and he was back in-country.

    Roy Benavidez has already shown himself to have great big balls of solid titanium.  But his biggest test was yet to come.  On May 2, 1968, six hours of action would present (then) Staff Sergeant Benavidez with the necessity of putting his training and courage to the test.

    His One-Man War

    Benavidez in Action.

    On the day in question, a patrol of twelve soldiers, consisting of three U.S. Special Forces advisors and nine Montagnard tribesmen, stumbled into an entire battalion of North Vietnamese infantry, numbering around a thousand men.

    The patrol called for help.  The first attempt at rescue was not successful; several helicopters returned from the first effort with wounded crewmembers and severe damage.  Another effort was quickly assembled.  Among those at the Forward Operating Base at Loc Ninh who hurried to react was Staff Sergeant Roy Benavidez, who scrambled onto a helicopter with his medic’s aid bag and a combat knife – no other weapon, not even so much as a pistol.  He did have his dedication and his adamantine courage, which would prove to be enough.

    On arrival in the middle of a firefight, SSG Benavidez soon realized that all of the Special Forces team members were either KIA or too badly wounded to move to the extraction point.  Benavidez directed the pilot of the helicopter he was in to drop him in a small clearing; he then ran 75 meters under heavy fire to the besieged team’s positions.

    During the 75-meter run, Benavidez was hit three times, in the face, the head and in the right leg.  But that wasn’t about to stop him.  He took charge of the team, directing those still capable of firing to cover the landing of the dustoff helicopter.  He threw smoke grenades to cover the withdrawal and, under intense fire, dragged half of the team members to the helicopter.  When it proved impossible to move the remaining team members, Benavidez picked up a rifle and, shouting to the helicopter’s crew to move to the remaining team members, ran alongside the bird and directed suppressive fire at the North Vietnamese troops.

    Finally, the entire team was loaded aboard the slicks.  Benavidez wasn’t done; he completed one last sweep of the area, retrieving classified papers from the dead team leader’s body even as the enemy fire intensified.  At one point a North Vietnamese soldier rushed him, striking Benavidez with his bayonet; Benavidez killed the NV with his combat knife and continued the mission.

    Finally, suffering from thirty-seven wounds and severe blood loss, Staff Sergeant Benavidez allowed himself to be dragged into the last helicopter, finally allowing the extraction team to un-ass the area, still under heavy fire.  Sergeant Benavidez’s wounds included seven “major” gunshot wounds, twenty-eight fragment wounds, and slashes to both arms from the bayonet attack.  The fragment wounds were in his head, scalp, shoulder, buttocks, feel and legs; his right lung was collapsed, he had been struck in the back of the head with a rifle butt and a 7.62 round had hit him in the back and exited just under his heart.  His actions on that day were credited with saving the lives of eight members of the twelve-man Special Forces team.

    Back at Loc Ninh, a doctor, believing Benavidez dead, ordered him placed in a pile of body-bagged corpses, until Benavidez mustered the strength to spit in the doctor’s face.  Since dead men don’t spit, Sergeant Benavidez was once again evacuated to the States, where he spent a year recovering from his wounds.

    During his recovery, General William Westmoreland visited Sergeant Benavidez, presenting him with the Distinguished Service Cross.  The commander of the 5th, Special Forces, LTC Ralph Drake, had put Benavidez in for the Medal of Honor, but one of the requirements for that award is an eyewitness; all the eyewitnesses for many of Sergeant Benavidez’s heroism were dead.

    Years later, however, an eyewitness surfaced.  One Brian O’Connor, who had been a radioman on the Special Forces team, had been evacuated to the States and since moved to Fiji.  Benavidez had thought O’Connor killed in action, but after reading an account of Benavidez, O’Connor wrote a ten-page account of the events of May 2nd, 1968.

    Finally, on February 24th, 1981, Master Sergeant Roy Benavidez was awarded the Congressional Medal of Honor, placed on him by President Ronald Reagan, who commented that “…if the story of his heroism was a move script, you would not believe it.”  You can read the full citation here.

    His Golden Years

    Roy Benavidez retired from the Army in 1976 and returned home to El Campo.  He spent his retirement wisely, traveling the country speaking to young people about the importance of staying in school and completing their education.  He was in wide demand as a speaker, but favored military audiences, where the example of his Medal of Honor was particularly inspiring; meeting an NCO whom generals salute first isn’t something that happens every day.

    Master Sergeant Benavidez, as I remember him.

    Side note:  This profile has some additional meaning to me, as I had the distinct honor of shaking Roy Benavidez’s hand once.  When I was attending Advance Individual Training at the old 91A school at Ft. Sam Houston, Texas, Master Sergeant (Retired) Benavidez had come to the post to speak to some of the classes.  He later toured the training area where my company was doing some hands-on training.  He spoke to every soldier and shook a lot of hands.  We had heard he would be on post, who he was and what he had done, so we were pretty excited; I remember shaking his hand, he looked at me very seriously and said, “Keep it up, we need medics.”

    It was a considerable thrill and a hell of an honor.  Men like MSG Benavidez don’t come around every day.

    Master Sergeant (Retired) Raul Perez Benavidez died on November 29, 1998, at Brooke Army Medical Center in San Antonio, and was buried with (well-deserved) full military honors at the Ft. Sam Houston National Cemetery.  I had just left my third stint on active duty in the Army not quite two years earlier and was saddened to learn of MSG Benavidez’s passing at the untimely age of 63.  The Army, like any other large institution, has many examples that young people can learn from, both good and bad; Roy Benavidez was certainly a good one.

  • 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.

  • Gold Standards II – The Colt/Browning 1911

    1911 Patent Drawing

    The Greatest 20th Century Martial Sidearm

    Resolved:  The Colt/Browning 1911 pistol is the standard by which all autoloading pistols must be judged.  Now that that’s established, I’ll proceed to tell you about this magnificent sidearm and how it came to be the gold standard of autoloading handguns.

    John Browning

    It should come as no surprise that the DaVinci of firearms was involved in the genesis of the 1911.  Browning’s reputation as a gun designer was well established long before he started in on autoloading pistols, having produced such outstanding pieces as the 1894 Winchester (a gold standard in its own right) and the first commercially successful, mass-produced pump shotgun, the 1897 Winchester.

    He started in on autoloading pistols with the tiny FN Browning M1900 in .32ACP, a pipsqueak of a little blowback pistol.  But in that same year, he also designed the short-recoil operated Colt Model 1900 in .38ACP, and it was that pistol that would become the grandfather of a great line of martial pistols.

    The Precursors

    The Colt 1900

    After two years the Colt 1900 and its .38ACP cartridge were modified and improved somewhat, splitting into three designs:  The 1902 Sporting Model, the 1902 Military Model and the 1903 Pocket Hammer Model.  All three were chambered for the .38ACP, but in 1905 a final model in this line appeared, the Model 1905 with a 4 7/8” barrel chambered for a short, rimless .45 caliber cartridge that would become the immortal .45ACP.

    In 1899 the U.S. War Department had been seeking an autoloading pistol design to replace the anemic M1892 revolver and its .38 Colt cartridge.  Tested were the Luger in 7.65mm, the C96 Mauser, the Mannlicher M1894 and the Colt M1900.  This early Colt has some issues with trigger linkages that adversely affected reliability in the aptly named “torture tests” of the day, and so the War Department purchased 1,000 DWM Lugers as an experiment.

    This experiment didn’t last.  The U.S. Army, Navy and Marine Corps had learned some important lessons in the Spanish-American War and the Philippine-American War that convinced the War Department to once more pursue a major-caliber autoloader.

    During that latter conflict, the troops facing stoned Moro warriors encased in rawhide armor found the .38 Colt revolvers lacked stopping power, but when the Army imported some M1873 Colt single-actions in the grand old .45 Colt, things changed; a tribesman with a couple of .45 Colt in his chest generally lost all interest in matters martial then and there.

    The War Department quickly sourced a stopgap, buying a lot of the big, rugged Colt New Service double-action revolvers in .45 Colt and deeming them the M1909 revolver; meanwhile the testing of autoloaders went on.  By this time the mind of Browning had fixed the shortcomings of the M1900 series pistols and had produced something vastly better.

    The 1911.

    The 1911

    The first round of service testing reduced the field of alternatives to three:  The Savage, the DWM Luger, and the new Browning/Colt M1911.  In one of the final tests, both Colt and Savage pistols were fired six thousand times over the course of two days.  When the guns grew too hot to hold, they were dunked in a bucket of water to cool them, and the firing went on.

    The Savage had 37 malfunctions over the course of the test; the Colt, none.  In short order the War Department had adopted their first primary issue autoloading handgun, the Colt M1911.

    The original 1911 had some ergonomic flaws.  The sights were somewhat rudimentary, at least by today’s standards (although better than the near-non-existent rear sight of the issue Luger.)  The hammer spur was long and low enough that it frequently dug into the web of the firing hand, especially if the shooter (like me) had big hands.  The thumb safety was small and easy to miss, and the trigger was too long for a shooter (unlike me) with short fingers.

    After the new pistol received its baptism of fire in the Great War, Colt made some changes based on the experiences of service members who used the pistol in the field.

    New and Improved! The 1911A1.

    The 1911A1

    In 1924, Colt engineers brought out a revision of the War Department’s .45.  The 1911A1 had improved sights, a shorter trigger and a lengthened grip safety spur to address that nasty hammer bite.  The Great War had revealed that the 1911 tended to shoot low in rapid-fire instinctive shooting, so the 1911A1 had an arched mainspring housing to address this tendency by making the muzzle hold naturally a tad higher.

    In this form the 1911A1 served until 1984 as the primary service sidearm for all branches of the U.S. military, a 73-year run, unprecedented in U.S. military history.  The Colt 1911 proved its mettle in battlefields all over the world.  The old slab-sides wasn’t as pretty as a Luger or as finely fitted as the Sig P-210 but it had three great qualifications for a martial pistol:  It was rugged, reliable and tough.  I’ve never handled or fired a Savage Model 1907, but I own a Luger, not a DWM as tested by the War Department but rather a 1938 piece made at the Mauser-Werke in Oberndorf.  The Luger is a beauty and one of the most naturally pointing pistols I’ve ever handled, but it’s fussy about dirt, finicky about ammo and, with its original, serial-numbered magazine, jams at least once in every mag full of ammo.  I love the Luger for its style, but I wouldn’t have wanted to be the miserable Nazi bastard whose life depended on the damn thing; if keeping my hide unperforated was in question, I’d take a homely old 1911 over the Luger any day of the week.

    Dad with his 1911, in 1945.

    I confess a nostalgic fondness for the M1911A1.  When I was a young fellow just out of my initial entry training, I was assigned to an Infantry battalion as a Company Aidman; as part of my field gear I was issued an old leather holster with “US” stamped on the flap and, to fill it, an M1911A1 pistol of a vintage that meant my father could very easily have carried the same sidearm in 1944-46 during his tenure in Uncle Sam’s colors.  A year later I was on the battalion bullseye pistol team when we won the Division pistol championship.

    My old 1911A1 was somewhat the worse for wear, but man did that thing shoot and shoot and shoot.

    The Commercial Models

    This is where the gold standard status of the 1911 design really shows.

    Colt sold the 1911 as the Government Model, chambering it not only in the .45 ACP but also in the .38 Super and 9mm Parabellum.  But after World War 2, the company began branching out.

    In 1949, Colt brought out the Colt Commander, which may have been the first major-caliber dedicated CCW piece.  The first Commander had an aluminum frame, a shorter slide and a 4 ¼” barrel.  In 1970, Colt added the “Combat Commander” with the same barrel/slide and a steel frame, at which time the original was renamed the “Lightweight Commander.”

    In 1970 Colt introduced the Series 70 in all Government Model variations, with a collet barrel bushing and some other internal improvements; this is probably the best 1911 Colt ever made.  Ten years later the Series 80 was produced, which added an internal firing-pin safety – this on a gun that already had two mechanical safeties, three if you count the external hammer.  Also added as a half-cock notch on the hammer.  The Series 80 was somewhat underwhelming to hardcore shooters, as the added gunk on the lockwork reduced the original design’s rugged simplicity.

    Both versions were also available in the Gold Cup match pistol trim.  If you want to do some serious bullseye shooting, you won’t find anything much better suited than a Series 70 Gold Cup.

    Beginning in the late Seventies, Colt found they had some competition.  Such upstarts as Springfield Armory, Federal Ordinance and Detonics began making fine pistols on the 1911 pattern.  In 1985, a company called Para-Ordnance introduced the first 1911 featuring a double-stack, 14-round magazine – and things just got more and more complicated after that.

    In today’s market for autoloading sidearms, the 1911 pattern still, after a hundred and eight years, still dominates.

    Today

    At present I own one 1911 myself, a simple mil-spec replica of the 1911A1 with Series 70 Colt lockwork, made by Armscor in the Philippines and imported by Rock Island Armory.  This was admittedly a nostalgia purchase, as I also bought a replica US flap holster to carry it, but that affordable (about $400) 1911A1 copy is much like the original; rugged and powerful.  I had a few feeding problems until I switched to Kimber magazines, and now it will feed empty cases and reliable shoots any ammo I care to feed it.  Rock Island Armory imports fancier versions of the same gun, and I am told that they are solid and reliable in whatever livery you choose to try.

    It would be more difficult today to name the gun companies that don’t make a 1911.  Smith & Wesson gave in to the inevitable some years ago and began building their own version of a 1911; ditto for Ruger.  Remington began building 1911s some years back.  Loyal sidekick Rat has one, a Remington 1911 R1 Carry, and it’s a fine shooter, although the trigger is a bit heavier than I’d prefer.

    My old buddy Dave has a Les Baer longslide, a 6” barreled, dedicated 1911 target gun; it’s so damn well made that you’d have to work at it to not shoot it well.

    Kimber, Springfield Armory, Randall, Olympic Arms, Sig-Sauer, Taurus, Dan Wesson, High Standard, and many more – all have bowed to the demands of the market and began making 1911-pattern pistols.  Forget about a gun designer wondering how his autoloader will measure up to the 1911; most of them now are just building 1911s and having done with it.

    The Colt/Browning 1911 is a rare kind of design from a rare kind of designer; simple, tough, solid.  In its original form it is reliable as the morning sunrise; with its original .45ACP cartridge it packs enough wallop to finish most tasks with authority.  The 1911 is as near an immortal pistol design as you’re likely to find and will probably last throughout this 21st century – making it, as resolved, the gold standard of autoloading sidearms.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    PENDERGAST: If there is another war —

    REP. NETHERCUTT: Which is prospective.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    (f) Limitation and Waiver.—

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

    (A) is not feasible;

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

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

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

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

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

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

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

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

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

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

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

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

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

    (i) a notification of the waiver;

    (ii) the President’s written concurrence; and

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

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

    Endnotes

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

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

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

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

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

    [iii] Id.

    [iv] Id.

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

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

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

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

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

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

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

    [xii] Id.

    [xiii] Id.

    [xiv] Id.

    [xv] Id.

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

    [xvii] Id.  Remarks of Congressman Shays.

    [xviii] Id. (emphasis added)

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

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

    [xxi] Id.

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

    [xxiii] 10 USC 1107 (1997).

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

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

    II. DOD’s Request

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

                                                                                                                                                                           

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

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

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

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

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

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

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

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

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

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

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

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

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

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

                                                                                                                                                                           

    Endnotes

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

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

    [iii] Id.

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

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

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

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

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

    [ix] Letter from John Deutch, Deputy Secretary of Defense, to Sen. John D. Rockefeller IV, Chair, Senate Committee on Veterans’ Affairs, November 17, 1994; in Committee files.

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

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

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

    [xiii] Id.

    [xiv] Id.

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

    [xvi] Id.

    [xvii] Id.

    [xviii] 44 Fed. Reg. ________.

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

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

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

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

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

    [xxiv] Id.

    [xxv] Abbreviated Protocol, signed by Roger W. Wiley and Darcelle Delrie, and other documents regarding “The Effects of Pyridostigmine Bromide on Vision”; attached to a cover letter from Martha H. Myers, Acting Chief, Human Use Review and Regulatory Affairs Office, Department of the Army, August 15, 1990. Documents are in Committee files.

    [xxvi] Id.

    [xxvii] Id.

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

    [xxix] Id.