David M. Ponder

From: Petty Officer Third Class David M. Ponder, 404 19 4374 United States Navy

I am thankful for the Committee’s time and concern regarding the Department of Defense mandatory Anthrax Vaccination Immunization Program. I hope that I can provide some insight and understanding to the Committee as to how this program has affected me personally and how this program is really being implemented, out in the “real world”, not as it has been discussed in theory by some members of the military establishment in these halls.

I am a Third Class Petty Officer in the United States Navy. I am in the Seabees, the construction force for the Navy. My views here in my testimony are my own and not meant to be taken as those of the Navy.

I have been in the Navy for a little over three years. I have a wife of two years and a son that just turned one year old. I am now deployed to Camp Shields, Okinawa, Japan. I have been here for six months. The way the Seabees work is that you have eight battalions. My battalion is Naval Mobile Construction Battalion 74. We are homeported in Gulfport, Mississippi. Every seven months we make a seven-month deployment. The rotation works that we are deployed to Puerto Rico, go back to homeport, then deploy to Okinawa, and then back to home, each stop being for seven months. When the battalion is deployed there is what is called Details. These are detachments from the main body of the battalion. For instance, this deployment we had details in Atsugi, Sasebo, and Iwakuni, in main land Japan. We also had two in South Korea, one in Chinhae and one in Pohang, the detail which I was to accompany.

My family and I returned from leave and we found out that anybody going to South Korea for any period of time was to receive the Anthrax Vaccine. The Chinhae and Pohang details had to get their first shot on Jan. 12. I went to the medical clinic and told my chief that I wasn’t taking the shot. Later that day, my chief and my company commander gave me a written order to take it and I refused that also. There were two other people that refused the shot at the same time. In early February, we went to Captain’s Mast. That is another name for non-judicial punishment (NJP). I had been wrestling with the idea of turning that down and requesting a trial by court-martial. The other two elected to take their punishment at Captain’s Mast. The punishment for them was 45 days of restriction and extra duty, reduction rate one pay grade, and have half month’s pay taken for two months. I opted to go with the court-martial because I did not want to take Captain’s Mast and be punished for the same thing six months down the road when this vaccine was ordered again. I knew that I was never going to take the shot.

I would like to explain my reasoning for this. Prior to this, there had already been rumblings about the program and the shot. I had heard and read about people who refused to take it and I had also read and heard about some of the adverse reactions people had had to the shots. I had heard about a study that showed the presence of squalene antibodies in a large number of Gulf War veterans who showed signs of Gulf War Illness. I believe that an article appeared in Newsweek in September 1999, timeframe. The article, and other research I conducted, pointed strongly to the fact that the DoD had given an experimental anthrax vaccine to troops during the Gulf War. People who had received the Gulf War anthrax vaccine and who never went to the Gulf had squalene antibodies in their system. As I understand it, the only way that those antibodies could be present was if squalene had been introduced into the body. During the gulf War, the DoD had given a number of drugs and vaccines to troops and was testing an experimental anthrax vaccine that contained squalene, a kind of booster for the immune system, on cattle. All of this made me very nervous and I had also read reports of veterans passing illnesses on to their families. My wife was pregnant with our son at the time and I was scared. Regardless of the source and information, I had some serious questions about the vaccine as my time to take it approached.

After discussing the matter at some length with my wife and agonizing over the decision, I decided not to take it; I decided that my family’s and my own long-term health were more important than my career in the Navy. At that time, my Navy career appeared to hold a bright future, I had enlisted in the Navy and received advanced promotion to E-4 upon completing my A school as a Seabee. I knew that there would be repercussions for refusing the vaccine, but I never dreamed how dire they would be. I originally had hoped that I would be allowed to part company with the Navy amicably, but that was not to be the case.

After I refused the vaccine, I was told that I would be given Captain’s Mast, which, under the Uniform Code of Military Justice, I had the right to refuse in favor of a court-martial. I didn’t particularly want this, but I knew that I was never going to take the shot, so I refused Captain’s Mast in the late January to early February timeframe, with my unit scheduled to deploy in March to Okinawa. Before the Captain’s Mast I had been told by our legal advisor that if I refused Captain’s Mast and elected to fight the order at a court-martial, I would more than likely be left in Gulfport. The vaccine, I was told, was a prerequisite to deployment. Despite this, after I refused Mast, I was told that I was going to be going to Okinawa to be court-martialed. Something about this didn’t seem right and so I hired a civilian attorney to represent me, a considerable expense for someone drawing E-4 pay with a wife and son. There had been two people in our battalion who, about a week earlier had gone to Captain’s Mast on drug charges. They refused Mast as well and went to a court-martial. They were both kept in Mississippi for their trials.

My civilian attorney tried unsuccessfully to prevent the Navy from taking me to Okinawa, but the judge denied our motion. I then was deployed to Okinawa in March and charges were brought against me. Captain Dale Saran, United States Marine Corps, was detailed as my defense attorney. During the time of my court-martial, I have learned a lot about the anthrax vaccine and the anthrax program. None of it has ever given me any reason to question my decision. In fact, everything has only further steeled my resolve and made me absolutely certain of the wisdom of my decision. I would like to detail some of the things that have happened and things that I have learned since this all began.

I have learned that there have never been any long-term studies on the effects of the anthrax vaccine. I learned that the company that makes the vaccine still, to this day, cannot get FDA approval because of problems with its production facility, including serious quality control violations that raise questions about what exactly is in these lots of vaccine. I do not have to detail all of the problems to this Committee. One only has to pick up the paper, it seems, and at least once a month there is some new revelation about the company, the vaccine, or the program that would scare me if I had taken the shot. It boggles the mind. Some examples:

-- Bioport, the company that makes the vaccine, had to be bailed out by the military to the tune of millions of dollars, and it currently is undergoing criminal investigation for how some of those funds were spent

-- The Secretary of Defense stated that four criteria would have to be met before the program would begin. One of those four criteria was independent review of the program by a civilian expert. As you well know, that civilian medical doctor from Yale, a so-called “expert”, turned out to know nothing about anthrax – his specialty involves Obstetrics and Gynecology. In fact, you are already well aware of this because he was asked to testify before congress but declined and will no longer answer questions about his role in the “review”

-- The FDA conducted an inspection of the company’s production facility last November and found over forty violations, most of them serious ones in how the vaccine was produced

-- Recently a worker at Bioport’s facility died in part because of the vaccine, according to the coroner’s report and now the FDA has in fact found squalene in lots of the anthrax vaccine, which the DoD has long denied that were ever there

It would be shocking in the extreme if all of this were new, but unfortunately, for the DoD, it is not. Committees of past Congresses have found these kinds of abuses of servicemembers’ basic rights for over fifty years. I urge members of this Committee to read the 1994 Rockefeller report, which details a laundry list of DoD use of members of our Armed Forces servicemembers as guinea pigs, sometimes with pure motives, sometimes not so pure motives. In fact, the one thing that I have learned through all of this is that the order to take the anthrax vaccine is patently illegal because it violates an act of this Congress, a law that was passed specifically because of some of the issues that arise when vaccines are used for purposes other than which they were originally intended.

I am speaking of 10 USC § 1107 and the history behind that law and the hard learned mistakes, which caused this Congress to enact such a law. This and previous congress’ experience in investigation Gulf War Illness revealed some startling problems with the DoD’s use of two particular drugs during the Gulf war, pyridostigmine bromide (PB) and botulinum toxoid (BT) vaccine. I will not presume to lecture members of this committee about things that they may already have heard, but it seems we have not learned, and the DoD certainly has not learned the lessons from the Gulf. Arguments about the anthrax vaccine’s efficacy or safety are really beside the point. A mandatory vaccination program is simply against the law. I provide a brief history only for those who may not be aware of it.

PB was licensed in 1956. The drug was tested safe and effective to work against a particular disease, myasthenia gravis, in a certain quantity, administered in a certain protocol, in a very limited population. That is how specific the license for a new drug must be in order to be approved by the FDA. PB was not licensed to be used as a pretreatment for nerve agents. The DoD asked for and obtained a waiver of the informed consent requirement in order to administer this drug and botulinum toxoid (“BT”), a vaccine. At the time, the PB was to be administered in 30 mg tablets, an amount less than that typically administered to myasthenia gravis patients. (See House Veterans Affairs Subcommittees on Health and Oversight Hearings, 16 Nov 1999, “Possible Health Effects of Pyridostigimine Bromide on Gulf War Veterans.”[1]) There were no long-term studies on effects of PB as a pretreatment for nerve gas, but the thought process was that since it had been used on myasthenia gravis patients since 1956 and produced a particular chemical reaction in the body that there should be no cause for concern with using it on soldiers. Unfortunately, this type of linear thinking does not hold true because it assumes linear relationships in the field of medicine. Subsequent experiments have indicated that PB may have severe adverse health effects when withdrawn, or when the patient using it is under heat, stress, and other conditions that were present during the Gulf. Additionally, it may in fact aggravate the effects of other nerve agents, or aggravate the effects of the same nerve agent in non-lethal doses. Of course no one could foresee this at the time, but it provides a lesson for all of us, particularly the military medical establishment, about the necessity for long-term studies when drugs are used for different purposes than they were originally intended. Additionally, the FDA withdrew the DoD’s waiver after the Gulf War and changed the regulations back to what they had always been, requiring a person’s (including servicemembers’) informed consent before administering such an investigational or experimental drug.

As a result of this experience and previous Congress’ inquiry into these areas, 10 USC §1107 was passed to prevent vaccination of someone with an “investigational” drug or a drug “unapproved for its applied use” without their prior informed consent. I can assure you that I have never given my consent nor has it been asked for by the DoD. What is particularly amazing to me is that the DoD knows that the drug is investigational but it continues to prosecute people like me. In 1996, the predecessor of Bioport filed an investigational new drug application with the FDA. One of the reasons for the application was a change to the anticipated route of infection of anthrax for an aerosolized infection. The original anthrax vaccine, the same one that is currently being given to servicemembers, was licensed as a prophylaxis against cutaneous (skin) exposure to the disease. The DoD expects that any weaponized anthrax will be in aerosol form and that is why it joined in the MBPI application and even urged the company to make the change. I have the seen the minutes of meetings between the DoD and MBPI personnel. The DoD knew and has known for quite some time that the current license for the vaccine is only for cutaneous anthrax. Furthermore, FDA regulations state that when such an application is filed, the use of a particular drug for the purposed listed in the application is investigational 30 days after the filing unless the FDA acts otherwise on the application. The President and CEO of Bioport, Mr. Fuad El-hibri, has testified before this Congress that BioPort still has the application pending before the FDA.

The DoD joined in that application and the proposed clinical experiment for the license amendment was to be conducted at Fort Detrick, Maryland. In fact, the clinical protocol required volunteers for this project. Somehow, though, the DoD now mandates that all servicemembers take a vaccine for which it requested volunteers in 1996. At the same time, the DoD comes before Congress and talks about the vaccine as safe and the vaccine’s long-term safety record with veterinarians. This is simply not true and doctors have testified before Congress that no long-term epidemiological study or tracking was ever done of these veterinarians or wool workers. Additionally, this is exactly the same kind of thing the DoD said with PB and BT before the Gulf in order to get a waiver from the FDA regulations for those drugs. We now know what a bad idea that was because battlefield use of PB with troops is not the same as the use of PB in a clinical setting on a limited population. The DoD’s AVIP program is a repeat of the DoD’s PB and BT biological warfare pretreatment programs. However, this time, the DoD doesn’t have a waiver from the FDA, but continues on with the program and prosecutions of those of us who refuse to gamble our long-term health on such a program. This Congress, this country, and veterans of the Gulf War have already learned the lesson the hard way, paying with taxpayer dollars and, in the case of veterans, their health and lives.

It appears as though history will repeat itself because the DoD will not admit what is so blatantly obvious to those of us staring down the barrel and who are more concerned about our health than our careers, the program was and is a bad idea, no matter how well intentioned.

I would like to add a final footnote to my testimony. My command took me to Okinawa because it was necessary for me to be with my unit. My unit is now preparing to return home to our homeport and our sailors to their families . . . except, of course, for me. Because my attorney was able to get a stay of my court-martial for the Navy and Marine Court of Appeals to hear one of our motions, I am being left behind in Okinawa. Meanwhile, all of the witnesses and even jurors of the court-martial will return home to their families while we await the appeals process which could take many more months or even result in dismissal of the case. Even my attorney has changed duty stations to Quantico, Virginia, while I remain behind, to do what, I have no idea. I was offered, through my attorney, one chance to return home if I agree to plead guilty for disobeying a lawful order at a lesser forum and accept my punishment. Unless I agree to that, I will, according to my command, be staying in Okinawa for who knows how long. My only regret in all of this is the price that my wife and son have had to pay for my decisions. I want to close by thanking my wife and family for all of their support through this.

[1] The tablets were to be taken 3 times per day; a “typical” myasthenia gravis patient might take 60 mg, 3 times and much more over a long period of time.