Glibertarians.com 2019 Archive

Author: Ozymandias

  • The Loss of American Social Power – Homelessness (with an aside on the racist origins of gun control)

     

    Asks a man for what he can spare with shame in his eyes...

     

    I have to confess to being interested in politics, perhaps unhealthily so. I wasn’t always. It wasn’t like I had some childhood fascination with my local senator. In truth, I think I’ve only ever voted in one Presidential election. (I may have voted for Perot, but I can’t honestly say for sure). Which is a nice way of saying that the current election cycle is a nightmare for me,* as it is for many thinking and principled Americans. It feels like the devolution of our country. To those who see politics as the public barometer of the state of a Nation, it feels like a forceful bellwether of decline, the dying gasp of a once great and moral Country.

    We’ve all seen the man at the liquor store beggin’ for your change
    The hair on his face is dirty, dreadlocked and full of mange
    He asked a man for what he could spare with shame in his eyes
    “Get a job, you fuckin’ slob” ‘s all he replied

    [CHORUS]
    God forbid you ever had to walk a mile in his shoes
    ‘Cause then you really might know what it’s like to sing the blues
    Then you really might know what it’s like…

    I had occasion to find myself in South Bend, Indiana, (yes, the one where Notre Dame is) for work. Driving up and down a particular main avenue running some errands, I noticed a man standing on the corner near the onramp to a highway. He was disheveled, though not too badly, and holding the ubiquitous sign that told his (alleged) story: “Homeless and I need to feed my family” read the message in red paint on the cardboard. I passed him in the afternoon without too much thought, though the prevalence of veterans among the homeless always makes me hesitate and ponder long after I’ve passed. Sometimes, if the timing is right, I’ll give what I can or have on me, though not always. I would imagine I’m like most people in both my thoughts and deeds with regard to the homeless. Perhaps better than some, certainly worse than some others. I’ve worked the odd soup kitchen or two for a church function or for a community service project that my kids had to and I rolled along.

    Albert Jay Nock was a brilliant and radical philosopher of the early 20th century. Born in 1870, he lived to see the First World War and died just as the Second one ended in 1945. One of his more well-known and seminal works was “Our Enemy, The State.” Finished and published during the height of FDR’s “New Deal” in 1935, Nock believed that the most effective form of government, and protective of individual rights, was the tribal “anarchism” of the early Native Americans. In an earlier work, titled simply, Jefferson, Nock argued that Thomas Jefferson was a firm believer that the smallest possible governmental units, or wards, allowed the people to, in Jefferson’s own words, “crush regularly and peaceably the usurpations of their unfaithful agents.”

    Nock’s later work in Our Enemy, The State focused on the difference between the spontaneous “social power” of individuals coming together for common cause and the forceful usurpation of social power by “State power.” His central thesis was set forth very clearly in the early part of the book and, in three short pages, Nock compels even the casual, disinterested, or even adverse reader to reconsider their entire understanding of State intervention in human affairs.

    One might wonder just what the hell all of this has to do with an (apparently) homeless guy standing on a corner in South Bend, Indiana, in mid-October, as I drove by him more than once over the course of several hours. Fair question. Let me convince you by pointing to one of the most trenchant parts of Nock’s argument that stuck with me:

    …just as the State has no money of its own, so it has no power of its own. All the power it has is what society gives it, plus what it confiscates from time to time on one pretext or another; there is no other source from which State power can be drawn. Therefore every assumption of State power, whether by gift or seizure, leaves society with so much less power. There is never, nor can there be, any strengthening of State power without a corresponding and roughly equivalent depletion of social power.

    Our Enemy, The State, p. 5 (emphasis added).

    The thesis seemed interesting to me, but I wasn’t quite sure what Nock meant by “social power” versus “State power.” I thought I quite understood the latter, but I wasn’t quite sure what the former was. Nock’s examples left me with a permanently-altered view of government attempts to intercede to “help” the citizenry. Nock provided two (then)-contemporary examples to illustrate his point more clearly.

    …it follows that with any exercise of State power, not only the exercise of social power in the same direction, but the disposition to exercise it in that direction, tends to dwindle. Mayor Gaynor astonished the whole of New York when he pointed out to a correspondent who had been complaining about the inefficiency of the police, that any citizen has the right to arrest a malefactor and bring him before a magistrate. ‘The law of England and of this country,’ he wrote, ‘has been very careful to confer no more right in that respect upon policemen and constables than it confers on every citizen.’ State exercise of that right through a police force had gone on so steadily that not only were citizens indisposed to exercise it, but probably not one in ten thousand knew he had it.

    (emphasis mine). We discussed the idea of a citizen’s arrest in law school, but I couldn’t and can’t recall much of what was said. My initial reaction reading Nock was to recoil at the thought that we all had the same powers of arrest as against each other as any officer of the law does, but then again, how much of the current problems in troubled neighborhoods stems from the fact that the local citizens who live there have abandoned even the most modest attempts at reducing the crime, violence, poverty, homelessness, drug abuse, etc., in their neighborhoods? The rejoinder is that the people are not armed and the drug dealers and gangs are and thus the people are at a distinct disadvantage, and hence comes the justification for military-grade police forces armed as well as or better than combat troops for the national defense; yet aren’t their some fundamental factors missing from that analysis? If the drug dealers and gang members inhabit those self-same neighborhoods, who is giving them succor? How do they put their heads on their pillows at night and feel secure in these same neighborhoods where they prowl and prey? These are, perhaps not coincidentally, the very same issues that confronted me while I was in Afghanistan, attempting to “police” a particular area that was rife with terrorism (and narco-traffickers, as well). I’ve watched many a frustrated military member talking to village elders asking, “Why are there rockets being launched from this area at our base every week? How is that happening?? Where do these people come from and sleep??”

    Upon careful inspection, what one finds is: first, the police do not actually live in the same neighborhoods that they patrol. In point of fact, they live in suburban outposts, miles and miles from the streets they pass through in their cars, as distant from the citizenry they supposedly serve and protect as they are from the gangs they are supposed to be interdicting. A lot of that is economics and has to do with the pay disparity between cops and the average inner city neighborhood they’re patrolling. Second, the people are at an “arms disadvantage” specifically because the State has disarmed them! It is a well-established historical fact that modern gun control suddenly became vogue during the late-1960s after armed blacks showed up to the California State Capitol armed with – (gasp) – “assault rifles!” (and shotguns, and pistols, as the above-linked article notes). As an aside, Clayton Cramer, a software engineer, does about as good a job as a law professor could in explaining that virtually ALL gun control laws have been racist in their origins and intent. This might seem self-evident when one considers that the right of a freeman to own weapons goes back to the days of sword ownership in England. If not still convinced, the Supreme Court made this explicitly clear in Dred Scott v. Sanford, 60 U.S. 393 (1857). Yes, that Dred Scott. The case itself should be required reading as a part of any basic civics course because of just how many incredible statements of historical significance for Constitutional law are in it – including statements by the Court about what defines a “citizen” and the Congressional power to “naturalize;” the right of states to admit immigrants, the status of descendants of slaves in free states vs. those of native Americans, the limits of judicial construction, and more – but of paramount importance for this discussion is what the Supreme Court used as one of its Constitutional justifications for finding Dred Scott could not sue for his freedom:

    More especially, it cannot be believed that the large slaveholding States regarded them as included in the word citizens, or would have consented to a Constitution which might compel them to receive them in that character from another State. For if they were so received, and entitled to the privileges and immunities of citizens, it would exempt them from the operation of the special laws and from the police regulations which they considered to be necessary for their own safety. It would give to persons of the negro race, who were recognised as citizens in any one State of the Union, the right to enter every other State whenever they pleased, singly or in companies, without pass or passport, and without obstruction, to sojourn there as long as they pleased, to go where they pleased at every hour of the day or night without molestation, unless they committed some violation of law for which a white man would be punished; and it would give them the full liberty of speech in public and in private upon all subjects upon which its own citizens might speak; to hold public meetings upon political affairs, and to keep and carry arms wherever they went.

    Dred Scott, 60 U. S., 416-17.

    To return to Nock’s point about social power and state power, what has happened in inner city black, and other minority, neighborhoods more broadly, is that the state has systematically usurped the “social power” – and the ability to wield it – that was originally resident in most neighborhoods and replaced with state power, which is only intermittently there “on patrol,” but not resident in that area.

    If you’re still not sure about Nock’s thesis, he provides many more examples that will shock the modern sensibility about how this country used to work.

    Heretofore in this country sudden crises of misfortune have been met by a mobilization of social power. In fact — except for certain institutional enterprises like the home for the aged, the lunatic asylum, city hospital, and county poorhouse — destitution, unemployment, “depression,” and similar ills, have been no concern of the State, but have been relieved by the application of social power. Under Mr. Roosevelt, however, the State assumed this function, publicly announcing the doctrine, brand new in our history, that the State owes its citizens a living.

    Students of politics, of course, saw in this merely an astute proposal for a prodigious enhancement of State power; merely what, as long ago as 1794, James Madison called “the old trick of turning every contingency into a resource for accumulating force in the government”; and the passage of time has proved that they were right. The effect of this upon the balance between State power and social power is clear, and also its effect of a general indoctrination with the idea that an exercise of social power upon such matters is no longer called for.

    Our Enemy, p. 5.

    Nock’s second example involved natural disasters and this is a matter I have given some thought, particularly in light of the revelations regarding the Clinton Foundation’s actions in Haiti.

    It is largely in this way that the progressive conversion of social power into State power becomes acceptable and gets itself accepted. When the Johnstown flood occurred, social power was immediately mobilized and applied with intelligence and vigor. Its abundance, measured by money alone, was so great that when everything was finally put in order, something like a million dollars remained.

    If such a catastrophe happened now, not only is social power perhaps too depleted for the like exercise, but the general instinct would be to let the State see to it. Not only has social power atrophied to that extent, but the disposition to exercise it in that particular direction has atrophied with it. If the State has made such matters its business, and has confiscated the social power necessary to deal with them, why, let it deal with them[!]

    Id.(emphasis added)

    I think the power of this example is that it has been repeatedly demonstrated through the modern era, considering the string of well-publicized failed federal disaster relief efforts through FEMA. A fairly comprehensive history of US disaster relief efforts proves the exact point that Nock was trying to make. Over time, as the federal government has increasingly intervened, local disaster relief efforts have tailed off and, in the ultimate slap-in-the-face, have even been prohibited and physically turned away by FEMA, most notably during the Katrina debacle in New Orleans.

    Nock’s final example of this diminution of social power was the one that stuck with me, though. Writing during the horrors of the Depression, Nock opined:

    We can get some kind of rough measure of this general atrophy by our own disposition when approached by a beggar. Two years ago we might have been moved to give him something; today we are moved to refer him to the State’s relief agency. The State has said to society, “You are either not exercising enough power to meet the emergency, or are exercising it in what I think is an incompetent way, so I shall confiscate your power, and exercise it to suit myself.” Hence when a beggar asks us for a quarter, our instinct is to say that the State has already confiscated our quarter for his benefit, and he should go to the State about it.

    Id.

    Guilt-free?
    Humor works best as a vector for Truth.

    And NOW we come back around to our homeless man on the street in South Bend, Indiana. (And Thanks! for sticking around).

    As I drove by him for the final time, it was past sunset, but not quite fully dark yet. He stood there in the same place holding the same sign. I couldn’t even tell if he had moved. I started to reach for my wallet but then the light turned green, so I accelerated away, leaving the man dwindling in my rearview mirror.

    “Aaaaahhhh….” I looked in the mirror as I went under the overpass, headed toward the comfort and warmth of my hotel. It was a rather warm October night, one of those last gasps of Summer before Fall fully settles in, he’d be alright… I thought of Nock’s words. “Fuuuuuck….” I muttered, rubbing my chin.

    I made an abrupt U-turn like any person who learned to drive in Rhode Island would, went past him, “banged another U-ee,” and there I was – and there he was – still holding his sign. It wasn’t the nicest part of town, but it wasn’t the worst, either. All I had was a ten and twenty dollar bill in my wallet.

    While stopped at the light, I looked left quickly where another car had pulled up to the light. There were three young black kids, all teenagers, ranging from perhaps thirteen to seventeen. The car was a bit dented up and they were watching me as I fumbled with my money, then tried to find the window unlock button in my rental car. I finally managed it all and motioned the man on the corner over; I handed him the ten as he leaned in my passenger window. He didn’t see it at first in the dark, but as he stepped back he said, “Oh My God, thank you. Thank you!” He started to walk away and I could hear his voice crack as he said: “I’ve been standing here for hours…”

    “I know,” I started to say, but it died on my lips. I’d driven by him all those times…

    I looked left and the three black kids were holding their thumbs up. The young kid in back was clapping. I just shrugged sheepishly. Then the car door opened and for a moment I thought, “Aw, fuck. Here we go. He’s going to ask for what I have left.” Then it became clear as I looked at the car it was because the window wouldn’t roll down. The teen leaned out and yelled: “I wanted to give him something, but I don’t have any money!”

    “Well…good on ya.” I said back. I couldn’t think of anything clever to say. “He needed that more than I did,” I yelled. “And I had it, so…” They smiled, waved, honked, and drove away as the light changed.

    And that was it.

    At a time when our country is rife with divisions over political parties, where we are told which lives matter, where we are no longer allowed to speak without fear of retribution if someone should be offended, where “hate speech” is now all the rage, and where I am told a car full of black teens should concern me because they are “superpredators,” where statisticians write papers claiming that abortions of black kids have helped drive down crime rates, where 1 in 4 or 5 or 7 homeless folks are military veterans, I think the “soft revolution” is what I now hope for…

    I hope that people will recognize that we all could and would be far more inclined to be charitable to our fellow man if we got to keep a little  more of our hard earned money, if our government wouldn’t tell us that IT is the ONLY possible solution to our problems, and if we all decided to simply act more charitably toward our fellow man – to take back our “social power” instead of waiting for the State to fix whatever the need is of the moment. Individual US citizens gave $258 Billion (yep, with a “B”) in 2014 – a record. At a time when the economy isn’t exactly humming. We should be proud of that, but how much better could we do if we got to keep more and decided to “just do it” ourselves, locally?

    Regardless of which shitheel gets elected, we should ignore their grand plans to “cure” _______ (drug use, poverty, racism, school shootings, or whatever the issue du jour is) and start exercising our social power. We don’t need to be told what the right thing to do is. We don’t need government to tell us to be kind to one another.

    We need to realize that we have to be the change we seek in the world and start doing it in the small ways that we can. Maybe eventually we’ll figure out we don’t need a three or four or five-letter federal agency to fake like it’s doing something while it hands out contracts to favored political donors and the people who really need help go wanting. Else I fear we risk continuing to ignore those in need among us because we have the excuse that “someone else” – like some bureaucratic agency or even the police – is going to do it. They’re not and they never have – and even if they did solve a problem, when was the last time you heard of some federal agency announcing that it had accomplished its purpose and thus was folding up so as not to waste taxpayer money? I won’t hold my breath waiting for the numerous examples…I’ll just try to exercise Nock’s social power to make the world around me a little bit better.

     

    *This post was originally written in the lead-up to the 2016 election.

     

    _____________

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

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

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

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

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

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

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

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

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

    FAV016 has its own uniquely disturbing history.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Wykoff:  . . . We have tried very hard to make sure that they are absolutely clear what our rules and regulations are and what our expectations are. We believe that they understand that. We believe that they have the capability of complying with all of our IND rules and regulations. As to whether they will comply in the next deployment situation, obviously we can’t predict that.

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

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

    Rockefeller: What are some of the options?

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

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

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

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

    ZOON: We don’t have the authority.

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

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

    SHAYS: That is your testimony.

    ZOON: We don’t have the authority.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Endnotes

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

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

    [ii] Id.

    [iii] Id.

    [iv] May 15, 1998, SecDef memo.

    [v] Nov 6, 1997, background briefing

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

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

    [viii] Id.

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

    [x] Id.

    [xi] 18 May 99 AF memo

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

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

    [xiv] AVIP Impl ltr 18 May 98

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

    [xvi] Id.

    [xvii]

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

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

    [xx] IG Report dtd March 22, 2000.

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

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

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

    [xxiv] Id.

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

  • Chapter 13 – Defense Delay and Praying for a Stay

    I sent out the judge’s ruling in Corporal Stonewall’s case to a list of people the same night the judge issued it. I was in despair. Now what would I do?

    Major Tom “Buzz” Rempfer, USAFR, was an Air Force Academy graduate, former F-16 pilot, then A-10 pilot, and flew for one of the major airlines in his day job. He was the poster boy image of an Air Force pilot. He also had been appointed by his Reserve Squadron Commander to a “Tiger Team” to investigate some of the “rumors” that were going around about the Anthrax Vaccine. His Team’s investigation would get him thrown out of his unit and publicly branded a coward by his CO. Tom and Major Russ Dingle, another member of the Tiger Team, were on the leading edge of the anthrax program’s problems. The “rumors” about which their CO was concerned began with the first Reserve squadron to receive the vaccine, based in Dover, Delaware. Most of the Reserve Air Force pilots who got the vaccine were also airline pilots in their day jobs. Thus, when some pilots started having adverse reactions, it meant they also lost their flight status in their civilian jobs because they were medially grounded. Colonel John Richardson, USAFR, was involved early on, as were Major Sonnie Bates’ attorneys, Lou Michels and Bruce Smith.

    Someone in that group mentioned the name of an attorney in California who was filing an extraordinary writ in an anthrax refusal case. The writ asked the intermediate appellate court, the Navy-Marine Corps Court of Criminal Appeals (NMCCA), to find that the judge had erred by ruling that the order to take the vaccine was not just lawful, but unquestionably lawful. California was seventeen hours behind Okinawa.

    I looked at my watch. I was on the phone at 12:30 am, or 0030 military time, 9:30 PST.

                                                                                                                                                                                                   

    On August 9, 2000, I made the same arguments I had made in Jason Stonewall’s case in David Ponder’s case. It was even more surreal because the judge had already ruled in Jason’s case and we both knew it. I tried my best to pretend that we both didn’t already know the outcome, but what was the point? It was the same judge. What were the odds he was going to arrive at a different conclusion in David Ponder’s case? I gave it my best effort, but most of my energy was being spent working on the extraordinary writ appealing the judge’s rulings on our motions in Corporal Stonewall’s case.

    I pounded the table, addressed his four findings specifically, probably even stepped over the line in calling his logic “ridiculous” that one could not plead a federal law in defense at a court-martial. I was heated and I wouldn’t have cared if he threw me in jail for contempt. We finished at 3:25 p.m. Wednesday afternoon.

    At 4:00 p.m. I was right back in court on Jason Stonewall’s case. We set dates for our next session of court, which would be the trial. We would have to listen to Stonewall’s legal officer say that he gave the order, it wasn’t followed, and then case over. Time was running out on us.

                                                                                                                                                                                                               

    On August 18, I got tricked, bamboozled, swindled, hornswoggled, whatever name you can use to describe being duped. It really happened sooner, right after our prior session of court, but the trap wasn’t sprung until the 18th. I walked right into it.

    The prosecutor had asked me a few days after our oral arguments in Ponder’s case if we could have a “quick” session of court in order to take the testimony of the officer who had actually given David the order to take the shot. The officer had flown in from the mainland or Korea and was there any reason we couldn’t preserve his testimony now while he was here? I had just come off of the rifle range a day early and the request seemed fairly benign. After all, it was a Friday afternoon at 1:30, what could happen? The prosecutor had asked me if I would mind letting him proceed with his witness and then he wouldn’t oppose a continuance request by defense. It seemed reasonable to me and the collegial thing to do was accommodate the request. On such minor accommodations do the courts continue to function and without which they simply would not.

    By then, I had already filed my extraordinary writ with the appellate court, which was ‘extraordinarily’ rough because of the time constraints, but it was filed with the court. I was also worried, but optimistic by then. NMCCA had issued a stay in the case of Ocean T. Rose, another Marine who had refused the vaccine in California. Rose’s case had proceeded a little ahead of our cases, but they were all essentially mirror image cases. The stay meant the court-martial below was stopped while the accused got a hearing in front of the appellate court on the judge’s denial of his motions. I was in steady contact with his counsel about potentially joining our cases for purposes of the stay. I figured the stay would issue within a week, maybe two. Sure, Chris we’ll take the government witness’ testimony, continue the case, and then boom! I’ll get my stay. I had even come out of the funk of depression I had been mired in for weeks.

    Imagine my surprise when the prosecutor stood up in court and objected to my continuance. When I stared over at him, less than two feet away, my eyes bored into him.  He wouldn’t look at me and that was probably wise on his part. A lifetime of playing hockey did not make me forget being wronged or improve the gentlemanly disposition I was supposed to display in court. I felt like I had just gotten a proverbial slash on the back of the legs. I was ready to drop the gloves and punch his teeth down his throat on the spot.

    “Sir, an extraordinary writ is currently pending before NMCCA,” I began in response to the Judge’s question about why I wanted a continuance. “It has been served on that Court. In light of that Court’s issuance of a stay in the case of United States versus Rose, we believe there are good grounds to request a continuance, especially where there have been no continuances requested by defense up to this point. This would be our first and it’s not an undue burden on the government to ask for one. Finally, sir, we are willing to stipulate to the government witness’ testimony, or allow that witness to be heard and then have the case continued, or we could even depose the witness.  Additionally, sir, you haven’t even officially ruled in this case on the record. Normally, the rules for appellate procedure allow the defense twenty days to appeal an adverse ruling.”

    Judge Stone seemed to think for a moment.

    “Have you made a forum election in this case?”  I wondered what that had to with anything and I went through my own mental checklist.

    “No, sir, we have not,” I answered evenly. Already the wheels were turning in my head. I had ridden an emotional roller-caster in this case, into hopelessness after the Judge’s ruling on our motions and back out with the Rose stay. I was not going to plummet back down again. Worst of all, I had violated my own rules, and I had given David Ponder – and his wife – my solemn word that he would not be going to jail tonight. I should have been tipped off when he told me that the command had him inventory his gear and was acting like he was. I should have put it all together then, but I hadn’t.

    “I am going to need a moment to reflect upon your proposal and the government’s opposition.” The judge sat back, pensive.

    “Sir,” the prosecutor began, while I fantasized of having a hockey stick in my hands, “the defense has just raised an issue. If you haven’t ruled yet, then what are they appealing at this point –” I was on my feet instantly.

    “Let’s talk about that for a moment,” the judge said. He turned to me. “Did you receive my electronic mail with regards to my anticipated ruling?”

    “Yes, sir, and that was the basis for sending the writ up to NMCCA.”

    The judge sat for a moment longer.

    “I’ll tell you what. What I am going to do is put my ruling on the record in a minute and then we’ll take up the matter of what, if anything we’re going to do today.  My current inclination is to proceed through arraignment and the taking of the government’s evidence and possibly ask you for evidence. Is that fair enough?”

    “Yes, sir,” I replied warily.

    “This court stands in recess.” I started to leave the courtroom, but the Judge indicated he would be right back and motioned for us to stay. He exited out his side door.  I stared at the prosecutor. He still wouldn’t look in my direction.

    The judge came right back in and hopped into his chair.

    He read through the identical findings he had made in Stonewall’s case on the motions. It still made my stomach sink to hear it in open court.

    “Now, at this point I’ll take the accused’s forum election.” I had a bad feeling about this.

    “Sir, if we could, we’d like to get a ruling on our request for a continuance before the accused elects his forum.” I no longer cared what the judge thought. I was completely out of pretense. If he didn’t grant our continuance, I was going to tell David to elect a jury with enlisted members as his forum. If the trial counsel was going to lie to me in order to get me into court, I was more than willing to go back on an email I had sent that I anticipated we would elect judge alone as our forum. Fuck ‘em both. The gloves were now off.

    “Well, you’ll have to give me a better reason than that… Or provide me with some law.” The judge looked at me and I knew he had every intention of finishing this case today. I had no lawyerly pretense left in me.

    “Sir, if this court does not grant a continuance, that means that if the accused elected judge alone as his forum, we could proceed through the entire case today. The government has one witness. In all likelihood, there is no question about whether or not the order was given. It is quite possible then that this case could conclude with an adverse finding against the accused with a writ pending before NMCCA where a stay is likely to issue. Sir, in the Rose case, the writ was served on NMCCA on 4 August and the stay was issued three days later on 7 August. We served our writ on the court on Wednesday afternoon, eastern standard time. That means tonight it will have been two days. I start a contested trial on Monday in another case. What harm is there to the government’s case to grant a six day continuance? If the stay doesn’t issue in that time, then we go forward.  This is a miniscule request, sir. If the judge denies that continuance request, then the accused will elect enlisted members in anticipation that the stay will be granted. We will need time to get the members’ questionnaires, prepare voir dire, et cetera. So, quite frankly, we’re using the procedure to give us the time we need for a stay to issue.  Straight up, that’s what we’re going to do.” I didn’t know if I had just violated a half dozen rules in the code of professional conduct or the JAG Instruction and at that point I didn’t care.

    The judge paused. He wasn’t angry, but he certainly didn’t seem too pleased.

    “I appreciate your candor, counsel. Nevertheless, I would imagine it’s an improper reason. Actually,” he paused for a moment, “there is no improper reason. If the accused wishes to be tried by members, that is a perfectly fine selection as far as the court is concerned. I do appreciate your candor. I hate to put the accused in a bind of forcing him to choose trial by members solely to for the purpose of getting delay in the case.”

    “Do you have anything?” he turned to the prosecutor.

    “Basically, sir, they’re threatening members if they don’t get their continuance because their sole purpose of requesting members is for a delay tactic.” If I had accomplished little else, I had gotten the prosecutor pissed and that alone made me feel better. “And we believe that to be improper. However, that’s within the discretion of the court.”

    “You know as well as I do that defense may and has every right to select trial by members. Would you like a few moments?”

    “Yes, sir, we’d like a brief recess.” The prosecutor stormed out of the courtroom.  I turned to David Ponder, who really looked nervous now, the first time I had seen him visibly shaken in the entire case. It had come home to him; he could be going to trial and likely jail in no time at all. He turned to me.

    “I’m not going to the brig tonight am I, sir?” I leaned over and looked at the back of the courtroom, out the door where Captain Kolomjec had gone.

    “Not tonight,” I whispered back. I said it with a confidence that I didn’t really feel. I had never promised a client anything, but overcome by my own confidence and trusting in the prosecutor’s promise, I had given David and his wife Jennifer my word that he was not going to the brig that night because there would be no trial.

    When Kolomjec returned, the judge allowed us to argue on why a continuance should be granted. I didn’t want to have David elect members, but I was willing to try anything at that moment. David’s freedom, Jason Stonewall’s, PFC Arroyo’s, everything hinged on a stay being issued.

    After we argued, the judge denied the continuance, despite the judicial mandate that continuances should be granted liberally. Worse yet, because I was starting a contested general court-martial in an officer case on that following Monday, the judge ordered that we would start the trial tomorrow, on a Saturday morning. I noted my objection three times, but we were sunk. If the writ didn’t come by the end of the work day east coast time, David Ponder would be going to the Brig the next day.

     

  • Chapter 12: The DoD “Evolves” on the Anthrax Vaccine

    Mary PENDERGAST (FDA):  As I indicated to you, it was not the type or quantity of information we would have hoped for.

    SHAYS (R-CT): That’s an understatement.

    PENDERGAST: It – it was.  We don’t disagree with you. This was war. This was the first time, and it didn’t work particularly well. We are in full agreement with you on that.

    SHAYS: This isn’t the first time the military has conducted themselves this way. And as long as they know the FDA’s going to be a paper tiger with the military, they will continue to do this. They will continue to basically say, bug off. And . . . as far as I’m concerned, that’s what they’ve said, and that’s what you’ve accepted. . .

    . . . And so we’re going to pursue this with the FDA, because in my judgment, the FDA allowed the military to do what they have to do in time of war, to have gotten a waiver from informed consent. They should have required that the troops technically, not just in spirit, be notified. And they should have made sure that it was being enforced . . . and [it’s] an outrage that it was not kept and data was not kept.

    And the FDA has not, in fact, really overseen this . . . And frankly, if you had said to me, we really blew it, just like the military, I could accept it. But you’re defending it, so now we’re going to pursue it.

    During the hearings on the Nixon impeachment, Senator Howard Baker (R-TN) asked the now famous question: “What did the President know and when did he know it?”[i] This same question is equally applicable to both FDA and DoD officials regarding the anthrax vaccine program. There has been a startling lack of candor and double-speak from both of these government agencies. While some of this could be attributed to normal bureaucrat-ese inside the Beltway, the level to which it has risen with this particular program goes so far beyond the “norm” as to be risible – and imputes far less honorable motives to those involved.

    _______________________________________________________

    In 1985, at the same time that the FDA’s panel was preparing its review on the anthrax vaccine, the Army had conducted its own review and sent out a Request for Proposals (RFP) for a contract to develop a new anthrax vaccine. The purpose of the RFP was to solicit manufacturers for their willingness to enter into a contract to create a new anthrax vaccine and the stated justification for fielding such a vaccine was that “[t]here is an operational requirement to develop a safe and effective product which will protect US troops against exposure from virulent strains of Bacillus anthracis.” This would seem to be a fairly straightforward proposition, but it immediately raises the question: why would the Army need a new vaccine, in light of the existing AVA? The Army RFP explains it quite simply:

    There is no vaccine in current use which will safely and effectively protect military personnel against exposure to this hazardous bacterial agent.[ii]

    In light of later DoD statements already examined and the ongoing program, it seems rather incredible that the Army announced in 1985, when there was only one existing license for anthrax vaccine (as there has been since the AVA was fist developed), that no vaccine in current use was safe or was effective – the two fundamental legal requirements for licensure by the FDA – safety and efficacy.

    The RFP singles out MBPI’s anthrax vaccine, noting that there is “a licensed vaccine against anthrax, which appears to afford some protection from the disease . . . [but]  [t]he vaccine is . . . highly reactogenic, requires multiple boosters to maintain immunity, and may not be protective against all strains of the anthrax bacillus.”[iii] Now, contrast this with statements by Dr. Kathryn Zoon of the Center for Biologics Evaluation and Research (CBER), who claimed in Congressional testimony in 1999 of the same exact vaccine that “to our knowledge . . . the vaccine that we are using protects against all known natural strains of anthrax.”[iv] She is either completely misinformed or lying. Setting that aside for the moment, what is even more troubling – and revealing – about her statement is that Dr. Zoon, a member of the FDA, the agency that is supposed to regulate Biologics, refers to the vaccine as one that “we are using[!]” Dr. Zoon is a senior government official in the Division that is supposed to regulate the safety of vaccines and monitor compliance with Good Manufacturing Practices.

    In this same hearing, Dr. Zoon dismissed the previous Notice of Intent to Revoke (NOIR) letter given to MBPI by her own Agency as if it were a minor matter. When asked directly “what the most serious problems are with the manufacturing of the vaccine and whether the manufacturer is taking steps to remedy those problems” Dr. Zoon replied that “. . . the manufacturer has had a notice of an intent to revoke. There were GMP deficiencies, and the manufacturer is currently engage in remedying those deficiencies.”[v] This is from the head of an agency that has found continuous and repeated cGMP violations, to such an extent that the Agency has called the manufacturing process “not validated,” had issued an NOIR which led to a “voluntary” shutdown of the entire facility just 20 months prior, had found that when the FDA was not notified that “[o]n 6/30/98, the firm installed a new reaction tank mixer on Tank (redacted).” Finally, one month after Dr. Zoon is telling Congress that this vaccine works against all known strains of anthrax, in November, 1999, the FDA inspectors would find again that “[t]he manufacturing process for Anthrax Vaccine Adsorbed is not validated.”[vi]

    In 1989 the DoD actually defended its position that the (then)-current vaccines were not good enough for mass troop inoculation. A DoD letter to Senator John Glenn of the Senate Committee on Government Affairs from Assistant Secretary of Defense Robert Barker proffered that “[c]urrent 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.”[vii] This can be contrasted with Dr. Sue Bailey’s claims on behalf of the DoD in 1999 that “[t]he vaccine . . . is effective and has an incredibly safe record. The evidence of vaccine effectiveness against aerosol exposure to anthrax is very persuasive.”[viii] Dr. Bailey was the Assistant Secretary of Defense for Health Affairs. She also offered that “[w]e have a vaccine that can protect our troops from this deadly weapon. It would be irresponsible for us to deploy our servicemen and women without using this safe and efficacious vaccine.”[ix] Evidently, the same exact vaccine, which in the intervening ten years had failed almost every conceivable FDA inspection for sterility and purity and potency and quality, had managed to transform itself in the eyes of the DoD from being “highly reactogenic” in 1985 and again in 1989 and lacking in “effectiveness against aerosol exposure” to being an essential force protection measure against anthrax. The only comparable transformation for a liquid involves water, wine, and a Jewish carpenter.

    In March of 1990, two Army doctors, Col. Takafuji, of the Army Surgeon General office and Col. Philip K. Russell of Fort Detrick, Maryland, describe the anthrax vaccine as a “limited use vaccine  . . . unlicensed experimental vaccine.”[x] This is interesting because in the same year that two prominent Army doctors were calling the anthrax vaccine “unlicensed” and “experimental”, the DoD was arguing to the FDA that it didn’t need a Rule 50.23(d) waiver for anthrax – or any other drugs, actually, regardless of their status. This medical admission, however, appears to have been an aberration in the DoD’s medical community, or at least in its messaging. The more consistent opinion, from senior Army physicians was actually that the vaccine was unlicensed and potentially hazardous. In 1994, Major General Ronal Blanck, later the Army’s Surgeon General, testified before the Senate Armed Services Committee about the anthrax vaccine as a possible cause of Gulf War Illness.

    Although anthrax vaccine had been considered approved prior to the Persian Gulf War, it was rarely used. Therefore, its safety, particularly when given to thousands of soldiers in conjunction with other vaccines, is not well established. Anthrax vaccine should continue to be considered as a potential cause for undiagnosed illnesses in Persian Gulf military personnel because many of the support troops received anthrax vaccine, and because the DoD believes that the incidence of undiagnosed illnesses in support troops may be higher than that in combat troops.[xi]

    This position was reiterated by Colonel Arthur Friedlander, the Army’s Chief anthrax vaccine researcher, in a chapter in a medical textbook, Plotkin’s Vaccines, stating that the anthrax vaccine was “unsatisfactory for several reasons.”[xii] Among these reasons were the high adverse reactions and the unknown “degree of purity” of the vaccine. The Senate Committee on Veterans’ Affairs, after hearing Major General Blanck’s testimony and many others, found in its 1994 report that “the vaccine’s effectiveness against inhaled anthrax is unknown. Unfortunately, when anthrax is used as a biological weapon, it is likely to be aerosolized and thus inhaled. Therefore, the efficacy of the vaccine against biological warfare is unknown. . . . The vaccine should therefore be considered investigational when used as a protection against biological warfare.”[xiii]

    By 1995, the DoD had, it appears, two plans in place to gain licensure for the anthrax vaccine as a pretreatment for a biological warfare attack. The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) had “developed a new recombinant protective antigen vaccine against anthrax. This vaccine was successfully tested in experiments using animals but has not been tested on humans.”[xiv] USAMRIID officials stated that the testing on this new vaccine “would take about 3 years, and FDA approval of the manufacturing of the vaccine could take years longer.”[xv] Either this dissuaded the DoD from pursuing this approach or the DoD had a concurrent plan to approach MDPH to see what kind of arrangement could be made with respect to the existing vaccine. In light of the previous DoD articles, responses, letters and statements, it appears that the length of time to bring an updated, recombinant vaccine through the FDA approval process was unacceptable and the project was abandoned.[1] A House Committee attributed the DoD’s abandonment of the new generation vaccine to the time it would take to complete FDA approval, perhaps 6 to 8 years.[xvi] In 1999, the “DOD consider[ed] further development of this [new] vaccine candidate an unfunded requirement.”[xvii] One has to wonder if this new vaccine’s status had anything to do with fear of undermining the new anthrax program that was announced in 1997. The GAO and Congress both criticized the DoD for focusing “almost exclusively on the older, FDA approved vaccine, to the exclusion of development work on newer, recombinant vaccine formulations.”[xviii] Whatever the reasons,[2] in 1995, the DoD shifted its focus from developing a newer, better vaccine to amending the license for the existing vaccine.

    In September 1995, the DoD contracted with Science Applications International Corporation (SAIC) to develop a plan to obtain FDA approval for use of the existing anthrax vaccine as a pretreatment for aerosol exposure to anthrax in a Biological Warfare (BW) environment. SAIC conducted an analysis and presented a plan to the Army that explained that there would be a significant informed consent obstacle to implementing this change in order to meet the regulatory requirements of the FDA and CBER. Dr. Anna Johnson-Winegar (U.S. Army) explained the legal status of the vaccine to Dr. Robert Myers (MDPH) in quite simple terms:

    “This vaccine is not licensed for aerosol exposure expected in a biological warfare environment.”[xix]

    Here is incontrovertible evidence that DoD officials at significant levels were acutely aware of the legal status of the anthrax vaccine at least two years before the anthrax program was commenced. While this is damning, it is only so because of the subsequent DoD actions. At the time, however, it appeared that DoD was preparing to comply with the regulatory requirements for obtaining a change to the existing license in order to get an indication for use against inhalational (aerosol) anthrax exposure expected in the BW environment.

    In October 1995, the Joint Program Office for Biological Defense (JPOBD) held a meeting to develop a plan for obtaining the necessary FDA approval for amending the existing AVA license. The minutes from that meeting indicate that the Army knew it had two big problems in obtaining FDA approval of a new licensed indication for inhalation anthrax. First, the efficacy tests used to license the vaccine were for a different vaccine, the Merck vaccine used by the Brachman study rather than the MDPH vaccine. Second, there was no scientific data (the necessary two “well-controlled human studies”) to support this change by FDA. [xx] A meeting was held on 20 Oct 1995 to discuss the process for modifying the MDPH anthrax vaccine license for several purposes: to indicate a reduced number of injections, to include a different route of administration (intramuscularly as opposed to subcutaneous), and to expand the indication to include protection against aerosol challenge of spores. Col. Arthur Friedlander said that “the original series of 6 doses was established in the 1950’s for an anthrax vaccine similar to but not identical with the MDPH vaccine.”[xxi] The minutes also noted what had been commented on by the 1985 FDA panel review of the AVA: “Studies of vaccine (not MDPH product) effectiveness in humans working in tanneries showed protection against cutaneous disease, but there was insufficient data to demonstrate protection against inhalation disease.”[xxii]

    This meeting also portended the beginning of the public relations campaign for the anthrax vaccine. Prior to that, however, Brigadier General Busby, the Joint Program Manager for Biological Defense, stated that: “the DoD’s position is ‘soldiers are citizens first’ and whatever studies are formulated, they have to be done with this concept in mind. Soldiers have the same Constitutional rights as other citizens.” These comments may have been addressing one of the SAIC briefing slides at that meeting. The slide is entitled “Volunteer Considerations” and is a comparison of two groups for use in any studies to amend the license for the vaccine. It depicts two rows: on one side is “At-Risk Forces” and on the other is “Normal Volunteers.” There are bulleted points on either side, indicating pros and cons of using the two groups. The At-Risk Forces have in their favor, it would appear, that using them would serve “Dual Purpose[s]” – “Immunized (??) force” and “Study needs.”  However, on the down side, At-Risk forces have “Informed consent complications,” which include record keeping and “assignment issues,” probably referring to the frequent rotation of service members. “Normal” volunteers have the problem of availability, but once you have them, there is better “access for study needs and record keeping”. They also come with a “cost” and using them “doesn’t support immediate readiness needs.” Finally, the last point against using soldiers points out the DoD’s concerns with public relations from the beginning: “Soldier ‘guinea pigs’ criticism.”[xxiii] Whether BGen Busby had his mind changed on soldier’s rights by the brief or not, he made an odd pronouncement at a meeting on the license amendment for the vaccine. According to the minutes, he “addressed the need to make the case that anthrax is currently the principal biological warfare threat. By protecting against anthrax and other BW threats, the vaccines serve as a deterrent.”[xxiv] We do not have transcipts of those meetings and we don’t know how exactly he “addressed” this supposed “need,” but it is troubling on many levels because it is a sweeping statement justifying the use of vaccines against an invisible, perhaps even non-existent, threat. A cynical person might reasonably infer that the General is suggesting running a PR campaign on the American people to justify knowingly using an unlicensed vaccine. It is also odd because this is not a meeting of operational planners discussing the terrorist threat to U.S. Forces. These are doctors mostly, discussing how to get a license amendment for the anthrax vaccine and suddenly a one-star starts talking about the need to make a case for the vaccine as a BW deterrent. There is no discussion about the intelligence or evidentiary basis for such a conclusion, nor an explanation as to why military doctors would need to ‘make the case.’ One can imagine the hushed silence or, perhaps worse, the nodding heads, after the General makes that statement. Was this an implication that informed consent was to be side-stepped and patients were to be told that this was a great deterrent to anthrax attack? Was this to begin some media campaign to justify the use of this vaccine off-label?  Whatever it was, the idea of soldiers having the same rights as other citizens did not ultimately win out.

    In accordance with one of the decision tree slides from the 1995 briefing, the U.S. Army was supposed to help MDPH prepare an Investigational New Drug Application in an effort to amend the license for three reasons: (1) a new route of administration, (2) a reduced shot schedule (from 6 to 3), and (3) to obtain an indication against aerosolized anthrax. This IND application was pending with the FDA at the time of all of the courts-martials mentioned in the prior chapters. The importance of this application cannot be overstated. By law, that application becomes effective thirty days after it is submitted for the purposes set forth therein. This means that if someone administers the drug in accordance with the IND submission protocol, by definition and by law it is an investigational use of the drug. That IND was not withdrawn, modified, or otherwise dismissed by the FDA.

    If the above wasn’t enough to demonstrate conclusively the absurdity of the DoD position, consider this: the clinical protocol for this IND was being conducted at Fort Detrick, Maryland, a U.S. Army base; it was being run by DoD doctors and administrators; and the volunteers were U.S. Army soldiers. Amazingly, in the coup de gras, the soldiers in that study were given information about the anthrax vaccine, filled out and signed consent forms, and they were using the exact same vaccine that DoD was concurrently compelling regular troops to take under threat of court martial. The IND application was submitted following an Army, Joint Staff, and OSD staff process in which there was concurrence that it was necessary to obtain FDA approval of a new licensed indication for inhalation anthrax before DoD could start mass anthrax vaccinations.[xxv]

    For whatever reason, this consensus was reversed within a month of William Cohen’s confirmation in January of 1997 as Secretary of Defense. This followed significant DoD pressure on the FDA, much like in 1990 prior to the Gulf War, to get permission to begin use of the anthrax vaccine for inhalation anthrax without obtaining a new licensed indication or completing the scientific investigation proposed by the Army in the IND application.[xxvi] There were phone calls made, including one by Admiral Ed Martin, a U.S. Navy doctor and the Deputy Assistant Secretary of Defense for Health Affairs, looking for a new interpretation of the anthrax vaccine license, one different than the DoD’s long-standing position that the vaccine was not licensed for inhalational anthrax.

    Now (in 1997) the DoD wanted the FDA to say that the anthrax vaccine was licensed for such a use. On March 4, 1997, four days after the retirement of long-time FDA commissioner Dr. David Kessler, the man who had negotiated and required DoD to get a Rule 23(d) waiver on the verge of the Gulf War, Dr. Stephen Joseph, the Assistant Secretary of Defense for Health Affairs, wrote to the acting FDA commissioner and stated that the “DoD has long interpreted the scope of the license to include inhalation exposure, including that which would occur in a biological warfare context.”[xxvii] Given what was already on the record by DoD officials, that statement cannot be spun any other way than as a bald-faced lie. In addition, Dr. Joseph asked “whether FDA has any objection to our interpretation of the scope of the licensure for the anthrax vaccine.” If Joseph’s assertion regarding the DoD’s position on the anthrax vaccine was correct and this belief was “long-standing”, then why would the DoD need to join in a clinical protocol and get an indication against aerosolized anthrax? Why did they even need to address that indication with the manufacturers? And why would the holder of the license, the maker of the vaccine, who presumably knows something about its own licenses and products, ask for an amendment to get the vaccine indicated for inhalational anthrax?  The answer is quite simple and mandated by the Food, Drug, and Cosmetic Act: it is because the AVA was never licensed for use against an aerosolized biological warfare attack.

    On March 13, 1997, acting FDA commissioner Dr. David Friedman abandoned the FDA’s regulatory role. He offered that “[w]hile there is a paucity of data regarding the effectiveness of Anthrax Vaccine for prevention of inhalation anthrax, the current package insert does not preclude this use . . . Therefore, I believe your interpretation is not inconsistent with the current label.”[xxviii] Notice that Friedman has now completely turned the law and FDA regulations – and the English language – completely on its head. The DoD now (apparently) had the green light it wanted and needed to go forward claiming that the vaccine was “FDA approved” for inhalational anthrax… Almost.

    There are obvious problems with these type of back-door, inter-office memos serving as policy statements of an agency: they circumvent the entire regulatory process. One person does not simply wave a magic wand and make a vaccine or drug licensed. Fortunately, enough people were apparently cognizant of the fact that outside entities might place undue reliance on the private informal opinion of FDA staff that the FDA drafted strict requirements for what it refers to as “advisory opinions” that might bind or commit the agency. 21 C.F.R. § 10.85(k) specifically states:

    a statement made or advice provided by an FDA employee constitutes an advisory opinion only if it is issued in writing under this Section. A statement or advice given by an FDA employee orally, or given in writing but not under this Section or §10.90 is an informal communication that represents the best judgment of that employee at that time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.[3]

    The above-mentioned “Friedman letter,” while consistently and extensively relied upon by the DoD as “proof” that the AVA was not an Investigational New Drug, was not issued under either of the required C.F.R sections. Accordingly, the letter is nothing more than an “informal communication” that has absolutely no legal effect. As such, the letter cannot modify the clearly defined legal status of the AVA that results from filing of the IND application by MBPI. What is even more bizarre about the DoD trying to solicit a favorable opinion about the AVA from the brand-new head of the FDA is that they are not even the manufacturer: they are a third party that wants to use it, but in no way does DoD have any ‘standing’ to do this where the company that makes the drug did not seek the FDA’s opinion on the vaccine’s status. This would be like Dow Chemical or Merck having an IND application for a drug pending before the FDA and then the American Medical Association steps in to ask the FDA to announce that the drug is actually not an IND, but licensed for the exact purpose that the drug’s own manufacturer is running a clinical testing protocol.

    The second reason that the letter is of no legal effect is that the Supreme Court had recently decided a similar case, Christensen, et al v. Harris Country, et al.[xxix] The Supreme Court specifically found that agency “personal opinion” letters are not entitled to deference by the Court, but only to “respect” – and then only to the extent that the letter’s interpretations are persuasive.[xxx] In this case, in light of the FDA regulations, Dr. Friedman’s letter is completely illogical because it rewrites the entire FDA regulatory scheme. His letter states that the DoD’s interpretation is “not inconsistent” with the approved labeling. This is nonsensical because drugs are designed, tested, and licensed for a specific purpose, not licensed for what’s on their label AND anything not inconsistent with that label. How could such be the case with the requirements for showing efficacy through two well-controlled human studies? In short, Dr. Friedman’s letter was worth little more than the combined total of the ink and paper with which it was written. Indeed, there could be no other result, given the fact that the letter is totally at odds with the IND application language of the manufacturer. It makes absolutely no sense to believe that an FDA official writing in his personal capacity can single-handedly invalidate the regulatory scheme adopted by the FDA to prevent the licensing and interstate movement of Investigational New Drugs at the request of some third party.

    What is truly mind-boggling about Dr. Friedman’s response is that just one week later, on March 20, 1997, CBER, the sub-agency of the FDA responsible for monitoring and inspecting the vaccine’s manufacturer, would issue the Notice of Intent to Revoke (NOIR) letter. To emphasize the recurring problems FDA had found at the manufacturer’s plant, the FDA letter stated:

    While these deviations were documented in the most recent inspection, we note that significant deviations have been documented during previous FDA inspections of May 4 through May 7,1993; May 31 through June 3, 1994; and April 24 through May 5, 1995. The seriousness of these deficiencies was emphasized to you in a letter dated December 22, 1993, and a Warning Letter dated August 31, 1995.[xxxi]

    To sum up, at the exact moment that the DoD is soliciting a favorable opinion/back-door approval from the head of the FDA for the AVA, the manufacturer is about to have its entire manufacturing process invalidated and threatened with having its license to manufacture the vaccine pulled by the results of FDA inspections. In an interview with the Canadian newspaper The Province, Mark Elengold, the Deputy Director for Operations at CBER, explained the significance of an NOIR letter. “. . . In the three years I have been in this job, I have done it about three times,” said Elengold. “It is a very serious tool. We view it . . . to be equivalent to an injunction . . . where we get a court to order compliance.”[xxxii] While the legal effect of Dr. Friedman’s letter is nil, it does make for great Public Relations and that’s exactly how the DoD would use the letter in seeking to win the PR battle that was about to begin. A number of interesting initiatives, press briefings, and press releases began not long after Dr. Joseph’s letter and Dr. Friedman’s response in March 1997.

    In retrospect, an overall pattern starts to emerge. There were several fronts on which the Secretary of Defense and the DoD tried to outdistance criticism of the program. The first claim was that the vaccine was “licensed.” This category had several sub-claims, such as long-term safety, use on veterinarians, and proven effectiveness of the AVA. The problem with these statements is, of course, their lack of completeness and/or their outright falsity. Some of these statements were well-beyond being just “spin.” As another example, at a background briefing on December 15, 1997, two senior defense officials laid out the upcoming anthrax vaccine immunization program (AVIP), noting that it was still six months away. There reporters asked some questions.

    Q:  The availability of the vaccine at this point, if you wanted to do a large program tomorrow, is there a stockpile of this vaccine available?

    A:  There’s a stockpile right now of seven million shots, which is about 1.2 TED – troop equivalent doses – of six shots, if you will. So there’s a large stockpile.

    A:  But that’s the stockpile . . .  We’re redoing the testing on it just to be absolutely certain before we go out. There’s been a great attention to safety in this.

    Q:  You found no impurities in the stockpile…

    A:  No.

    This answer came six months after the process for manufacture had been invalidated by CBER.

    The second area where the DoD attempted to promote the AVA harkens back to Brigadier General Busby’s statements at the meeting about the license amendment plan. There he talked about the need to “make the case” that anthrax was the number one biological threat. This was relatively easy to accomplish because anthrax is a real biological threat, but the DoD would engage in an unprecedented fear-mongering campaign in order to support the vaccine. Making it even easier were events in the headlines, such as Aum Shinryuko cult’s sarin gas attack on the Tokyo subway, and the U.S. members of the U.N. inspection teams being forbidden from participating in Iraqi weapons’ inspections by Saddam Hussein. DoD briefers never missed an opportunity to point to the possibility of a terrorist attack on U.S. soil or to exaggerate the lethality of anthrax.[xxxiii] This is not to say that it is not lethal, but DoD briefers constantly called it “100% lethal,” which is a bizarrely hyperbolic claim. What does “one-hundred percent lethal” even mean? Does that mean everyone who breathes in even a molecule of anthrax spores? The answer to that is unequivocally “No.” What amount constitutes a lethal dose then? One briefer referred to 10,000 spores, while other DoD information refers to the LD50 as the number in thousands of spores that constitutes a lethal dose. The SecDef himself participated in this campaign with his then-famous quote during a live TV appearance with Cokie Roberts on ABC’s “This Week.” While holding a five pound bag of sugar, Cohen said that if “this was anthrax, it could wipe out half the population of Washington, D.C.”[xxxiv] One expert later called that “one of the most irresponsible statements ever made by a politician.”[xxxv] Additionally, Secretary of Defense Cohen gave several speeches about the proliferation of these weapons, exaggerating the number of countries capable of manufacturing and delivering such weapons. In three different speeches, Cohen put the number(s) of countries capable of weaponizing anthrax at 30, 25, and finally 10.[xxxvi]

    The final area of this media campaign was a kind of rhetorical fallback position, which consisted of a series of statements that can be summarized as “what else are we supposed to do?” The old “if it saves even one life” play. A number of high-ranking DoD officials made statements to the effect that they would be “derelict” if they didn’t give this vaccine in light of the threat, or that they were “morally obligated” to vaccinate soldiers, or that “it’s the best response” or “it’s the only response” that we have. These statements frequently relied upon the record of the individual making the statement as a testimonial to the vaccine’s necessity.

    The problem with all of this is that it ignores three critical aspects of immunizing people against their will. First, it ignores the law requiring informed consent. Second, it ignores the lack of efficacy for the claims being made in support of the anthrax vaccine. In other words, there had been no studies, and could never be ethically, proving the effectiveness of the vaccine against aerosolized anthrax. Even the animal studies, while promising, indicated a less than stellar performance against certain strains of the anthrax bacillus.[xxxvii] Finally, it completely elides the validity and viability of other (non-vaccine) treatments.

    There existed at the time a highly effective, fully licensed antibiotic with studies showing excellent success rates against anthrax if taken right after exposure. This has been a common military method of response to a number of other chemical agents, so there didn’t seem to be any explanation as to why the DoD couldn’t use these already licensed antibiotics in the event of an anthrax attack.[4] An illustration of the DoD’s refusal to consider other treatments occurred at the December 15th press briefing, when a reporter asked about other treatments against anthrax. The briefer’s answer:

    With regard to those medical countermeasures, antibiotics. They’re effective in sustaining service members until antibodies are built. Provides immediate protection, but it has to be sustained over a period of time, until the antibodies are developed. There are limited minor side effects with the dosage required of the antibiotics. Antiserum is a very fast reacting, immediately protection capability, but again, it’s limited, and it has to be re-administered to sustain protection. It’s expensive and the same minor side effects are associated with it.

    Vaccines are the way to go. It takes time to develop the immunity, but the immunity lasts for a long time. Limited, minor side effects. I think the rate of those folks that we’ve vaccinated over the last five years associated with their jobs — either lab workers, workers in industry in the private sector, special operations forces, there’s been about a 96-97 percent rate of no reaction at all, and those that did have had limited topical reactions, minor swelling or redness, things like that.

    It’s extremely difficult to circumvent a vaccine. This would ward against genetic engineering of other strains. Once that vaccine’s in, it takes a major effort for an unfriendly nation to try to develop another type of anthrax strain that we would have to dissect, if you will, figure out what it was and then rework our vaccine. But it is very effective. It provides the protection we need over the long haul.

    The briefer acknowledges the immediate nature of antibiotics and the long time necessary to develop immunity for vaccines, but offers that “vaccines are the way to go.” Additionally, probably most surprising, are the briefer’s references to the “minor reactions” (with a negative implication – “you’ve still got those minor reactions”) and the incredible claim of “96-97 percent no reaction at all” with the AVA, something that had never been true of the AVA. The briefer’s claims that the vaccine “would ward against genetic engineering” of other strains also had no evidence to support it. This makes the briefing read rather like an unsubstantiated point-by-point denial of the criticisms that had been levelled against the program. Either the briefer was unaware of BioPort’s problems, the DoD’s own studies on the highly reactogenic nature of the AVA, badly informed, or he was straight-up lying. With the DoD and this program, it is difficult to know which one.

    The DoD’s media campaign was fairly extensive, involving many briefings with the press in each of the above areas. For example, On April 16th, 1997, two senior defense officials gave a briefing on the DoD’s role in helping to train and “enhance the capability of federal, state, and local emergency response agencies to prevent and respond to domestic terrorist incidents involving weapons of mass destruction.”[xxxviii] On April 25, 1997, a notice was sent to the press that the Marine Corps’ Chemical Biological Incident Response Force (CBIRF) would conduct “demonstrate its ability to effect consequence management following the simulated detonation of a chemical-biological terrorist device” in the Washington, D.C. area on April 30th. On April 28th, 1997, Secretary of Defense Cohen gave a speech at the University of Georgia, speaking at a conference on Terrorism, and told listeners that a rogue state attack using chemical-biological weapons was “not only plausible, it’s really quite real.”[xxxix] In fact, he told his audience that “about 30 countries now possess mature chemical and biological weapons programs with 12 having advanced missile capabilities.”[xl] Secretary Cohen emphasized a comprehensive response that included active and passive measures against such attacks. By November 1997, when U.S. members of the U.N. Inspection teams were not allowed by Saddam Hussein to participate in weapons’ inspections, anthrax and chemical-biological warfare (CBW) and weapons of mass destruction (WMD) were being talked about as imminent. There was November 14, 1997, briefing by a senior defense official on Iraq’s CBW capability.[xli] On related fronts, General Ronald Blanck, the Army’s Surgeon General, and Vice Admiral Dennis Blair, on November 6, 1997, were briefing the press on the DoD’s improved ability to track vaccine’s and medical health of service members.[xlii] This would of course be a crucial part of any DoD vaccine program because of its historically atrocious record (including in the Persian Gulf War), which has already been laid out in prior chapters.

    In sum, the DoD’s position on the AVA went from an open acknowledgment of the vaccine’s scientific and legal limitations in light of the vaccine’s history, to one of hyperbolic and straight-up false statements about its biological safety and efficacy and its legal status. This cannot be explained by bureaucratic turnover, or loss of institutional knowledge, because in many cases it involved the exact same people and agencies reversing their position within weeks, or even days, in some cases.

    Endnotes

    [1] Ironically, had this approach been taken, by 2002 the DoD would have had a new generation anthrax vaccine, presumably more effective and less reactogenic than the current vaccine, but more importantly, one actually licensed for its intended use. The quick fix did not turn out that way. A Congressional committee reached the same conclusion in 2000. See House Committee on Government Reform, 106 H. Rpt. 556.

    [2] I do offer some hypotheses and supporting evidence for them as to why the DoD changed courses in later chapters. It is for the reader to decide if that evidence is compelling enough to support those assertions.

    [3] The informal and non-binding nature of such “advice” is also made clear in the IND regulations themselves.  21 C.F.R. § 312.41(c).  Moreover, it is noted that the communication did not even involve the IND applicant, Bioport, Inc.

    [4] I address possible/likely reasons that the DoD insisted on this particular vaccine over all other possibilities in later chapters and let the reader decide.

    [i] Congressional Impeachment hearings on Pres. Richard Nixon.

    [ii] Request for Proposals (RFP) No. DAMD 17-85-R-0078, US Army Medical Research Acquisition Activity, Fort Detrick, Frederick, MD, 16 May 1985.

    [iii] Id.

    [iv] Congressional Hearings on the Anthrax Vaccination Program, Oct 12, 1999, NSVAIR (II), testimony of Dr. Kathryn Zoon, cited in H. Rep. 106-556, fn 22, “DoD AVIP: Unproven Force Protection.”

    [v] Id.

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

    [vii] 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.

    [viii] Congressional Hearings on the Anthrax Vaccination Program, Oct 12, 1999, NSVAIR (II), testimony of Dr. Sue Bailey, cited in H. Rep. 106-556, fn 22, “DoD AVIP: Unproven Force Protection.”

    [ix] Id.

    [x] Infectious Disease Clinics of North America, 3/90, p. 156

    [xi] Maj. Gen. Ronald Blanck, Commanding General, Walter Reed Army Hospital, to Committee staff, 414 Russell Senate Office Bldg., Washington, DC, 4 Feb 1994, from Senate Report 103-97, 8 Dec 94, page 35.

    [xii] Plotkin’s Vaccines, ed. Stanley A. Plotkin, Walter A. Orenstein, Kathryn M. Edwards. See chapter by Dr. Arthur Friedlander on anthrax.

    [xiii] Senate Veterans Affaires Committee staff report 103-97, 414 Russell Senate Office Bldg., Washington, DC, 4 Feb 1994, from Senate Report 103-97, 8 Dec 94, Note 61-63.

    [xiv] GAO T-NSIAD-99-226, July 21, 1999 (p. 10)

    [xv] Id.

    [xvi] H. Rep. 106-556, p. 32.

    [xvii] GAO report 99-226 p. 10

    [xviii] H. Rep. 106-556

    [xix] SAIC Corporation plan, 29 Sep 1995, enclosure to memorandum from Dr. Anna Johnson-Winegar (US Army) to Dr. Robert Myers (MDPH), US Army Medical Research and Material Command, Fort Detrick, Frederick, MD, 5 Oct 1995.

    [xx] LTC David Danley, “Minutes of the Meeting on Changing the Food and Drug Administration License for the Michigan Department of Public Health (MDPH) Anthrax Vaccine to Meet Military Requirements”, held on 20 Oct 1995 meeting; Joint Program Office for Biological Defense memorandum, 13 Nov 1995.

    [xxi] Id.

    [xxii] Id.

    [xxiii] Briefing slide from Anthrax Vaccine License Amendment Plan: Information Briefing for Joint Program Manager, DoD Biological Defense, page 18. Oct 19, 1995.

    [xxiv] LTC David Danley, “Minutes of the Meeting on Changing the Food and Drug Administration License for the Michigan Department of Public Health (MDPH) Anthrax Vaccine to Meet Military Requirements,” held on 20 Oct 1995 meeting; Joint Program Office for Biological Defense memorandum, 13 Nov 1995.

    [xxv] Id.

    [xxvi] Dr. Stephen C. Joseph, DoD ASD/Health Affairs, letter to FDA Lead Deputy Commissioner Michael Friedman, 4 Mar 1997

    [xxvii] Id.

    [xxviii] Id.

    [xxix] 120 S. Ct. 1655, 2000 U.S. LEXIS 3003 (May 1, 2000).

    [xxx]  Christensen, 2000 U.S. LEXIS 3003 at 19-20.

    [xxxi] FDA letter to MBPI, 20 Feb 1997.

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

    [xxxiii] See, e.g., DoD Press Briefing, Dec. 15, 1997.

    [xxxiv] SecDef William Cohen on “This Week” with Cokie Roberts, Nov. 1997.

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

    [xxxvi] Combating Weapons of Mass destruction, by Jim Garamone, AFPS, 4/30/97; William S. Cohen, “Preparing for a Grave New World”, Washington Post, Op Ed., July 26, 1999; William S. Cohen, “Force Protection is My Priority”, Army Times, July 31, 2000.

    [xxxvii] See GAO Report T-NSIAD-99-148, FN 4, 5.

    [xxxviii] DoD Background Briefing, Apr 6, 1997.

    [xxxix] Combating Weapons of Mass destruction, by Jim Garamone, AFPS, 4/30/97

    [xl] Id.

    [xli] Nov 14, 1997, DoD background briefing

    [xlii] DoD News Briefing, Nov 6, 1997.

  • 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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Endnotes

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

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

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

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

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

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

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

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

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

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

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

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

    [xi] Id.

    [xii] Id.

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

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

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

    [xvi] See note xii.

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

    [xviii] 21 CFR 51002, 51008

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

    [xx] Id.

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

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

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

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

     

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Justin looked at me.

    “I follow everything except the Latin.”

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

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

    “Backwards Virginia school systems.”

    “Yeah, right.” He sat down.

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

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

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

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

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

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

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

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

    “You know what?” he began, smiling.

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

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

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

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

                                                                                                                                                               

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

    June 27, 2000.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    PENDERGAST: If there is another war —

    REP. NETHERCUTT: Which is prospective.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    (f) Limitation and Waiver.—

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

    (A) is not feasible;

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

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

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

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

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

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

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

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

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

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

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

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

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

    (i) a notification of the waiver;

    (ii) the President’s written concurrence; and

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

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

    Endnotes

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

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

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

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

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

    [iii] Id.

    [iv] Id.

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

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

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

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

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

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

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

    [xii] Id.

    [xiii] Id.

    [xiv] Id.

    [xv] Id.

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

    [xvii] Id.  Remarks of Congressman Shays.

    [xviii] Id. (emphasis added)

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

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

    [xxi] Id.

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

    [xxiii] 10 USC 1107 (1997).

  • Chapter 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.