Glibertarians.com 2019 Archive

Category: Federal Power

  • 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.

  • The NSA Reaches Out to Glibertarians

    NSA Headquarters at Fort George Meade, Maryland.

     

    Greetings, Glibertarians!

    I’m Michael T. Hunte, junior investigative agent with the National Security Administration.

    On behalf of the NSA, allow me to address you in the spirit of friendship and cooperation which our republic holds so dear. As your site’s designated Security Representative and Advisor, it is my duty, but also my pleasure, to greet you in the proper manner outlined in our organization’s recent Community Outreach Program, also known internally as Operation Good Neighbor.

    Please don’t let the officious nomenclature fool you! This is simply our way of saying ‘Hello!’ to various chat groups, website memberships, and blog communities that catch our interest over the normal course of fulfilling our duties.
    Now, don’t get yourself all worked up over NSA taking an interest in your charming little website. Why, the past few months I’ve spent reading through many of your daily posts have been quite pleasurable. I’ve learned an awful lot about so many subjects of interest to your regular members, from firearm maintenance to craft beers, Mormonism to spatchcocking. I especially love the humor that your members generally employ – the many Monty Python references, the good-natured ribbing over grammatical errors. And that Steve Smith character – I wouldn’t want to meet him in a dark alley!

    That’s why I feel privileged to be your website’s personal Representative. I feel like I already know so many of you already, even though you’ve been nothing more than i.p. addresses and blips on a drone pilot’s screen to me previously. Let’s face it, in the course of my duties, I get to see the good and the bad – all of you who pick your noses surreptitiously while watching pornographic videos, for example. Do not like, as the kids say! But, it’s not all bad. Gary M., I’m glad you finally had that wart removed… that sucker was getting huge!

    In that spirit, I want us to have a closer working relationship. The NSA isn’t just a bunch of soulless, faceless badguys listening to you make mousey sounds while you have sexual relations in the ‘privacy’ of your bedroom. It’s that, sure, but so much more also!

    Totes not us, Glibs. These guys are CIA.

    We respect your membership’s adherence to the Constitution, an allegiance that, I promise you, our organization shares. And we work hard to protect our Constitutional Republic against enemies, both foreign and domestic. But, we need your cooperation!

    I want you Glibertarians to feel free to come to me with any concerns you might have concerning our nation’s freedom, and the selfless protecting of same. You’ve heard the phrase, ‘See something, say something’? Well, I want you to know, I’m here to listen to any of your concerns. Any time, day or night, you can come to me with any troublesome information you might have regarding the safety of our beloved Republic.

    You know, some in my organization aren’t quite ‘down’ with Constitutional protections the way you Glibs are. We need to bring those Glibbers to heel, some of them say. Well, I just look them right in the eye and I dare them to lay a finger on this fine website and its membership! As your NSA Representative, I take my role very seriously, and I want you to know that I’m on your side.

    Mike Hunte is here for you. Mike Hunte is open and ready for whatever you’ve got, my friends. Got some pent-up aggression and need a handy but private outlet? Well, you just lay it all on Mike Hunte, Mister! Mike Hunte isn’t afraid to take a pounding, believe you me.

    Mike Hunte is fair and open to all. Why, just the other day, my pet Yorkie, who my family calls York Hunte, got up on the bed (she knows she’s not supposed to!) and, well, left a piddle behind. I looked at my wife and said, “Look what York Hunte did! York Hunte deserves a good beating!” But don’t worry. My wife Madchek Hunte (she’s from a former Soviet country, but don’t worry, she’s been thoroughly vetted!) told me that the little darling was sorry and deserved to be loved on rather than punished. Well, how could I say no to that? I ended up giving the little critter a kiss on the nose.

     

    The other night my daughter Emily, whom we all call Tinkerbelle, or Tink Hunte, came home late after a ball game. She was having a dustup with her beau, and boy, was she sore! She read him the riot act – how can he treat Tink Hunte that way? Doesn’t he know what a precious treasure Tink Hunte is? She really had that boy against the wall until I thought I ought to step in to cool things down a bit. Now, I dearly love Tink Hunte, but she was so hot that I was afraid she was gonna hurt that fella. Well, pretty soon the two youngsters made up, thank goodness, because who can say no to sweet Tink Hunte?

     

    It’s so cute that you people think this will help.

    So you see, Glibs, I’m in your corner. I’m also in your bathroom, your kitchen, your automobile, your electronic devices. Should you feel the need to reach out, just speak your peace: the NSA is always within earshot.

    Take care, fellow citizens, and I shall certainly see you later.

    Excelsior!

    Michael Hunte
    Junior Agent
    National Security Agency

  • 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)

  • The Glibening, Part Ten: The Triumph of Preet Bharara

    This type of portrait is known as a head shot. The flag is obligatory for federal officials, but the pattern is a visual distraction and it divides the picture into two fields.

     

    Previously…

    Preet Bharara inserted the business end of the nose hair trimmer into his left nostril, held his breath and pressed the power button. The unit whirred and he worked it around then pulled it out and blew out that nostril onto the small towel hung round his neck by the chain and clamps rig a former lawclerk had left behind in her desk.

    He was still stinging from the Woodchipper Incident. He could have gotten away with that, too, for at least for long enough to have gotten their addresses, if it hadn’t been for the pesky internet. He had been publicly humiliated, even called a “muttonhead,” by a prominent First Amendment attorney. His attempt to use a court order to prevent them from even talking about it had backfired spectacularly. But he had taken the heat and managed to keep Judge Forrest’s profile as low as possible; something the bench was sure to notice.

    He trimmed inside his right nasal passage and blew out his right nostril productively. He removed the thin towel with the words “US GOVERNMENT” woven into one end and shook it out over the trashcan before dropping it in the official government hamper. He washed his face and took a fresh towel from the stack. He inspected himself again in the mirror.

    Fortune had smiled upon him unexpectedly. At that very moment his top man was strolling through the offices of Thought! magazine tagging along with NYPD on a crazy girl call that had come in that morning during the taskforce meeting. No warrant needed. Even if they were squeaky clean, and he knew they weren’t, NYPD would manage to find something.

    Having found no flaw, he opened the dry cleaning bag hanging from the back of the door and removed a black robe which he slipped over his head. Next, the wig, from its wooden stand next to the mirror. Once properly enrobed and bewigged he examined himself one final time. Perfect.

    Preet exited the bathroom into the robing room. He pressed the button that caused a light on the court clerk’s bench to flash, then slowly walked to the door to the courtoom. Sarah was right on time with the gavel; three perfectly timed raps. He was foregoing the “oyez” and formal opening of court for the occasion. Richard and Corey, the courthouse technicians, were crouched behind their video cameras, grinning. Court staff loved to torture interns and lawclerks whenever possible, and this was a welcome break from taping oral arguments and portrait ceremonies.

    Interns Dorian, Raymond and Ming stood awkwardly behind the lawclerk bench wearing robes and wigs shorter and less ornate than his own, making their tights and silver-buckled shoes more prominent. Mediocre legal scholars, but gifted singers, all. Last June he had had Ramesh assemble all of the serious resumes into a single pdf document so he could search that for “choir,” “chorus,” and so on. Once he had his backup singers chosen he read their resumes and created notes justifying his hiring decisions based on their legal merits – just like creating a parallel construction for a prosecution.

    Ramesh. His favorite. His protege. A brilliant legal mind, but the boy couldn’t carry a tune in a sack. He so wanted to text Rami to ask for a progress report, but he had resolved to let Rami conduct this all by himself. He trusted Rami, despite the boy’s penchant for independent, sometimes unorthodox, thought. He was glad Ramesh was soon to be married, a good, practical Indian wife would whip him into shape.

    The robing room door opened behind the judge’s bench, the judge’s chair had been removed for the taping. He strode measuredly towards the bench to give the door a chance to close; Richard flashed him the thumbs up to cue him that the door had shut. The guys were really good at what they did; he’d have never thought about the open door and robing room lights being a distracting background.

    He daintily grasped the slender shaft of the judge’s gavel, raising it theatrically and miming a rap in the air. Sarah hit the play button on the Karaoke machine and everyone started to sway to the doo-wop beat. The interns had been rehearsing for months. This was their big moment, the culmination of their internships. The next few minutes would determine their careers, if not the future course of American jurisprudence.

    Lyrics appeared on the screen in the back of the courtoom behind the cameras. He waited for the ball to touch the first letter, and began singing.

     

     

    Oh, yes, I’m the Great Preetinder,

    He remembered hearing the song on the radio as a young boy in Eatontown, New Jersey. He had always thought the song was about someone named Preetinder, someone like him. Until the day in sixth grade when Angus Cohen had slammed him up against a locker. “That song isn’t about you, fag, it’s about pretending to be something you’re not.”

    He had abandoned the song until one day it occurred to him that it didn’t matter what the actual lyrics said; what mattered was the interpretation which sounded right to a contemporary audience. The song should be interpreted in manner that made the most sense the context of today, author’s original intentions be damned. By the time he was in high school it had become his personal fight song which he hummed to psych up for tests and debate matches.

    Do, Re, and Mi, as they were known throughout the courthouse, harmonized “woo, woo,” sweat running down their faces under the hot television lighting.

    Preetinding that I’m doing well,

    Doing very well indeed, thank you. And not pretending, in either sense of the word, but Preetinding. A special sort of thing that only someone named Preetinder could do. Preetidude. The Preetness.

    He was getting interviewed on Thursday by Judy Woodruff about his take-down of Silk Road. Normally he wouldn’t grant an interview, but PBS was respectable television. And it didn’t hurt that Ms. Woodruff was still quite attractive. Washington had not only approved of the Woodruff interview, but had broadly hinted that it would be a very good thing for him. That could only mean he was being groomed for something higher.

    He’d instantiate the humble civil servant saving the internet from organized crime. Unfortunately, a website which just moved money around didn’t sound very sinister. But DOJ had prepared a slideshow explaining why untraceable financial transactions were a Very Bad Thing. And illegal. And drugs.

    Woodruff’s people had asked if they could redo the slideshow with “higher production values,” to which DOJ headquarters had also, surprisingly, agreed provided that DOJ got to review the final for accuracy. Media people were notorious for wanting to “simplify” things which meant sexing them up at the expense of accuracy.

    My need is such I Preetind to much,

    It had been a long, hard climb to get to where he was today. Chess club. Forensic speaking. Debate club. Law review. Internships.

    He had worked not only for himself, but for all Indians. The Indian-American community was strongly self-policing. They were determined to prove themselves as a hard-working, modern people. Doctors, lawyers, small merchants. Indians left all that village shaman bullshit back in India. And the swastikas. The woodchipper people had trolled him hard on that. They had no sense of restraint; there was nothing funny about Nazism or even the snarky implication thereof, and there was particularly nothing funny about debating which way to feed a federal judge into a woodchipper.

     

    A headshot with a uniform background. This is a female US Supreme Court justice from the early Twenty-First century wearing much simpler court dress.

     

    I’m lonely but no one can tell,

    Someone who was lonely because he spent too much time on work to have real friends. But loneliness and hard work were the price for becoming the man of the hour. He’d show Jindal and Haley who was the chief Indian; national office beckoned him like a Seventh Avenue whore.

    Laughing and gay like the clown.

    He’d have the last laugh over the Woodchipper people, and clowns were sinister after all. They’d never see this, but in his heart he’d know that he could put on a better production number than them. Rip off Bollywood, would they? He’d reach deep into American culture and show them he could best them at their own game. Bum-flashing antics, bad lyrics and muddy single-camera recording were no match for what the mighty powers of the federal government could bring to bear.

     

    Another dreadful example of official portraiture. Bookshelves of law books are an almost obligatory background for judicial portraits. The shelves create lines going through the subject’s body, making the whole thing look choppy.

     

    Word of it would eventually get back to them, though. He was planning to show the finished product at Bar Talent Night at the Second Circuit Judicial Conference this Summer. The Woodchipper people had friends in surprising places; he could think of at least two law professors who would be there who he knew participated anonymously in Thought! Magazine’s online fora.

    The interns harmonized the final line perfectly.

    All the performers froze.

    “Cut,” yelled Corey.

    It’s just like a real one, only smaller.

     

  • 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.

  • Economic Corner featuring Paul Krugman and Winston’s Mom

    This week Krugman declared DEMOCRACY IS DEAD!!!, which explains why it suddenly got dark out.

    Did it die in darkness?  Well, that will depend if you paid enough to keep the lights on.

    Democracies used to collapse suddenly, with tanks rolling noisily toward the presidential palace. In the 21st century, however, the process is usually subtler.

    Authoritarianism is on the march across much of the world, but its advance tends to be relatively quiet and gradual, so that it’s hard to point to a single moment and say, this is the day democracy ended. You just wake up one morning and realize that it’s gone.

     

    In their 2018 book “How Democracies Die,” political scientists Steven Levitsky and Daniel Ziblatt documented how this process has played out in many countries, from Vladimir Putin’s Russia, to Recep Tayyip Erdogan’s Turkey, to Viktor Orban’s Hungary. Bit by bit the guardrails of democracy were torn down, as institutions meant to serve the public became tools of the ruling party, then were weaponized to punish and intimidate that party’s opponents. On paper these countries are still democracies; in practice they have become one-party regimes.

    And the events of the past week have demonstrated how this can happen right here in America.

    Does this book by chance mention anything about the bloody English?  You know that island with terrible looking women that voted on something in the past couple years the government has gone to great lengths to ignore?  I’m going to go out on a limb before I look this up– you probably said it was going to be terrible for them to vote leave….

     

    ….I was right!

    At first Sharpiegate, Donald Trump’s inability to admit that he misstated a weather projection by claiming that Alabama was at risk from Hurricane Dorian, was kind of funny, even though it was also scary — it’s not reassuring when the president of the United States can’t face reality. But it stopped being any kind of joke on Friday, when the National Oceanic and Atmospheric Administration issued a statement falsely backing up Trump’s claim that it had warned about an Alabama threat.

    Why is this frightening? Because it shows that even the leadership of NOAA, which should be the most technical and apolitical of agencies, is now so subservient to Trump that it’s willing not just to overrule its own experts but to lie, simply to avoid a bit of presidential embarrassment.

     

    Think about it: If even weather forecasters are expected to be apologists for Dear Leader, the corruption of our institutions is truly complete.

    Holy.  Fucking.  Shit.  Who. The. Fuck. Cares.  Have hurricanes ever hit Alabama?  Yeah.  Have hurricanes changed course with no advance warning?  Yeah.  Is Alabama located somewhere near where they were expecting the hurricane to hit?  Yeah, sure.

    None if that matters because it blasted all over the Bahamas, changed course, and will now plow through Nova Scotia.

    If it did hit Alabama, and no warning was given at all, you;re enough of a scroungy little fuck to blame the Oranje man for not seeing it coming.  It must be nice to be a dishonest asshat like Krugman that has no bearing on anything resembling reality, because he can find any way to pretend he’s smarter than everyone else.  I even picked up a Trump sharpie from his campaign website, look what I can do with it!

     

    Which brings me to a much more important case, the Justice Department’s decision to investigate automakers for the crime of trying to act responsibly.

    The story so far: As part of its jihad against environmental regulation, the Trump administration has declared its intention to roll back Obama-era rules mandating a gradual rise in fuel efficiency.

    You might think that the auto industry would welcome this invitation to keep on polluting. In fact, however, automakers have already based their business plans on the assumption that fuel efficiency standards will indeed rise.

    Well shit.  Maybe it has something to do with the increasing fuel efficiency regulations that have been in place since the 70’s?  This whole saving gas thing just popped up out of nowhere like the last time you had an akward boner while watching Bob Ross?

    They don’t like seeing their plans upended — in part, one suspects, because they understand that the reality of climate change will eventually force the reinstatement of those rules. So they have actually opposed Trump’s deregulation, which they warn would lead to “an extended period of litigation and instability.”

    And several companies have gone beyond protesting. In a remarkable rebuke to the administration, they have reached an agreement with the state of California to comply with standards nearly as restrictive as the Obama rules even if the federal government is no longer requiring them.

    Now, according to The Wall Street Journal, the Justice Department is considering bringing an antitrust action against those companies, as if agreeing on environmental standards were a crime comparable to, say, price-fixing.

    They are agreeing to something as an industry that affects the overall cost of ownership of a product exclusive to that industry, that sells products to literally everybody in the country.  I will wait for you to explain why this is not somehow subject to antitrust laws….

    This would be disturbing even if it came from an administration that had previously showed some interest in actual antitrust policy. Coming from people who heretofore haven’t indicated any concerns about monopoly power, it’s clearly an attempt at weaponizing antitrust actions, turning them into a tool of intimidation.

    And it’s also clear evidence that the Justice Department has been thoroughly corrupted. In less than three years it has been transformed from an agency that tries to enforce the law to an organization dedicated to punishing Trump’s opponents.

    You clearly paid no attention to that whole FISA thing in the news, because only team-red friendly outlets are reporting it.

    Who’s next? In at least two cases, Trump appears to have tried to use his power to punish Amazon, whose founder, Jeff Bezos, owns The Washington Post, which the president considers (like this newspaper) to be an enemy. First he pushed for an increase in the post office’s package shipping rates, which would hurt Amazon’s delivery costs; then the Pentagon suddenly announced that it was re-examining the process for awarding a huge cloud-computing project that Amazon was widely expected to win.

    In each case it’s hard to prove that these were efforts to weaponize government functions against domestic critics. But who are we kidding? Of course they were.

    The point is that this is how the slide to autocracy happens. Modern de facto dictatorships don’t usually murder their opponents (although Trump has been fulsome in his praise for regimes that do, in fact, rely on brute force). What they do, instead, is use their control over the machinery of government to make life difficult for anyone considered disloyal, until effective opposition withers away.

    And it’s happening here as we speak. If you aren’t worried about the future of American democracy, you aren’t paying attention.

    I am worried…I am worried Shit-weasels like you will eventually be in charge. The difference between you and me, is I don’t like the government meddl8g in the market regardless of the asshole in charge.  Tell me, did you give a flying fuck about Obama’s antitrust actions in telecom, private health insurance, oil/gas…even a merger between Staples and Office Depot. Seriously, did team Obama think thy were going to corner the printer paper market and jack up prices of reams of printer paper?  Who the fuck else will sell me pens!?!? How much of a shit-weasel do you have to be to argue against one president’s obscene meddling in the market and are perfectly okay with it when your prefered asshole wants to screw with the market?

    Don’t forget to cup the balls, schmuck.