Category: Regulation

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

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

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

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

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

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

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

“It’s hard not to, sir.”

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

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

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

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

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

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

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

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

A:  I haven’t read the actual study.

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

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

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

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

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

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

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

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

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

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

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

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

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

Endnotes

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

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

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

[iii] Id.

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

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

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

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

[viii] Id.

[ix] Id.