Calling the ShotsThe realities of the Anthrax Vaccination Immunization Program

rutherford.org ^ | 03/25/05 | By Kathryn Goodson

[tacomonkey2002]

Calling the Shots The realities of the Anthrax Vaccination Immunization Program

By Kathryn Goodson 03/25/05

“Before I go into detail about my adverse reactions to the Anthrax vaccination, I’d like to point out that when I was vaccinated, I was not informed of any potential adverse side effects or of the Vaccine Adverse Events Reporting System (VAERS). There were no hand outs, product inserts, literature, or health questionnaires to read or fill out. I just had to report to immunization, turn in my shot records, and receive the shot. When I voiced my concerns about receiving this vaccine, I was told failure to comply was punishable under the Uniformed Code of Military Justice (UCMJ). I was uncomfortable with accepting the vaccination, but I complied. I put my faith in the system.”

—Thomas J. Colosimo, from his testimony before the Committee on Government Reform hearing, “The Anthrax Vaccination Immunization Program.”

On a good day, Thomas Colosimo could last four hours at his job answering phones and taking messages. A former Senior Airman in the U.S. Air Force who traveled the world as a Nondestructive Inspectionalist, Colosimo is one of the more than 3,000 service people who have come forth about their suffering and severe disabilities from the mandatory Anthrax Vaccine Immunization Program (AVIP), a move that he and many others state ruined their military careers.

Now in his early thirties, the former competitive weightlifter lost control of his body’s reactions after receiving four of the six anthrax program shots between 1998 and 1999. He might go out for a walk, suddenly “drop out” and wake up in an ambulance. His wife regularly has to perform rescue breathing techniques on him. He cannot drive, be left alone or stand for a long period of time. He forgets events and entire days and suffers from continual dizzy spells, vertigo, periods of delirium, staring and blurred vision. Diagnosed with full-blown “anthrax intoxication,” Colosimo spends much of his time confined to a wheelchair and clad in a football helmet, just in case.

Yet nothing surpasses the poor treatment he has received from the military and its medical staff, who have repeatedly asserted that Colosimo was fabricating his symptoms and then sent him away. For instance, in one nearly tragic incident in 1999, Colosimo’s wife was forced to perform CPR on him after he collapsed during a series of shots. Hearing commotion, a military policeman entered the room, pulled him from the floor by his breast nipple and repeatedly screamed “faker.” However, by the time Colosimo’s Pennsylvania state representative stepped in more than a year later and ordered that he be transferred, his health was permanently damaged.

Even now, the military’s reaction to Colosimo’s illness is familiar to service personnel who are also suffering adverse vaccine reactions—at least those who are willing to risk coming forward. Military doctors immediately dismiss the patient’s claims, superiors accuse them of lying and, eventually, the establishment they have faithfully served casts them aside.

And, yet, Colosimo considers himself one of the luckier ones; at least six deaths and numerous debilitating illnesses have been blamed on the vaccine—a pattern Pentagon officials vehemently deny. Moreover, military trust and morale within the ranks is on a sharp downward spiral. In the Air Force alone, an area hardest hit because adverse symptoms such as autoimmune diseases and severe migraines are far more troubling for airmen and women operating under strict “sick call” policies, AVIP critics assert that the unpredictable anthrax vaccine is the number one reason for sharp surges of commercial pilots resigning their Air National Guard commissions. As of October 2000, Government Accountability Office (GAO) reports indicated that 25 percent of Air National Guard and Air Force Reserve pilots scheduled for the vaccination resigned, rather than take it. All in all, nearly 600 service men and women have refused the shots, often facing severe consequences. Captain (Dr.) John Buck was the first military physician to be court-martialed for refusing the vaccine—a decision which held a sentence of 60 days’ restriction to the base, a fierce letter of reprimand and a fine of $21,000. Petty Officer Third Class David Ponder, also court-martialed after refusing the vaccine, spent a 60-day sentence in the brig. More than 440 refusers were docked in pay, reduced in rank or given a less-than-honorable discharge; 51 were disciplined through court-martial.

And while military officials continue to tighten their grip on service people’s vocal opinion about the vaccine, the increasingly frenzied undercurrent of vaccine nervousness is only swelling. With more AVIP adverse reaction stories released every month, such as that of Sgt. Sandra Larson, who passed away shortly after her sixth shot from Aplastic Anemia, and now-retired Army Chaplain Dave Hodge, who has been diagnosed with both lupus and colorectal cancer, nearly every military person knows someone “who knows someone” who’s suffering—the young man in his 20s who limps with a cane; a newly married wife at 25 left unable to conceive a child; a son with grand mal seizures; a neighbor who previously ran eight miles a day and can no longer tie her own shoes; a cousin with MS; a sister who has died.

Perhaps the most controversial and shunned shot ever concocted, this vaccine remains the center of a long-time legal, medical and political battle—so feared that military personnel would rather spend time in the brig than roll up their sleeves.

Besides the Defense Department turning a blind eye to the recurring problems with the vaccine in the name of terrorism preparedness, many AVIP critics link the numerous vaccine quandaries to the vaccine maker itself, BioPort Corporation of Michigan, which was contracted by the Department of Defense to make the vaccine. The current anthrax vaccine was originally licensed by the Food and Drug Administration (FDA) in 1970, having never undergone human efficacy field trials. In fact, the only trial of an anthrax vaccine in humans took place in the 1950s—for a different vaccine. Furthermore, according to a current Army study, adverse reactions to this vaccine range from 40 percent in men to 70 percent in women, much higher percentages than originally reported. And because either informed consent or Presidential waiver of that consent is required for the present use of this vaccine—neither of which exists for this shot—the current AVIP vaccine program is illegal.

BioPort, the sole-contract anthrax vaccine manufacturer, has a long and troubled litany of problems with the vaccine, including the production of contaminated batches as well as non-sterile products, both of which were used. BioPort was also charged with switching labels on batches of vaccine, only to reveal false expiration dates. The company was further slammed by the GAO for not informing FDA officials of changes to its manufacturing process that actually altered dose potencies by a factor of 100. Batches were also discovered with the presence of squalene, an adjuvant which is illegal in the United States. But quality control issues at BioPort Corp. are only the beginning—BioPort has failed seven consecutive routine inspections by the FDA since 1992. So severe were BioPort’s problems, in fact, that the FDA blocked the release of all batches of the vaccine for several years. Some believe this situation led to the severe vaccination shortage whereby, when the time came, military officials panicked and decided to test whether “adding to” the shot might not increase its potency.

Despite serious questions from ranking officials concerning the company and its tumultuous vaccine history, however, in September of 1998, Secretary of the Army Louis Caldera, on behalf of the DOD, granted full indemnification to the BioPort Corporation, thus protecting them from legal liability of any kind. Then, immediately following the anthrax attacks of 2001, BioPort overnight earned its clearance to once again begin manufacturing the vaccine after failing years of FDA inspections. Doubt about the program was rampant, but action was slow to adhere. In October of 2001, Defense Secretary Donald Rumsfeld was quoted as saying in a Pentagon News briefing, “We’re going to try and save [the program]. There have been other efforts that have failed over a period of years. And it may or may not be savable…it’s not very well underway, as you point out…they have not been approved by the FDA, as I understand it. They do not have what looks to be—well, I shouldn’t be characterizing a private entity that way, but things have not been going swimmingly for them.” The program continued for the following three years.

While there is a glimmer of optimism regarding the AVIP for current and future military personnel—on October 27, 2004 a federal judge ruled that the government had failed to properly license the vaccine and the mandatory injections be halted—the victory is bittersweet for former soldiers like Colosimo, where the bulk of the damage is already done. Likewise, many fear the program will be up and running again as soon as the Pentagon files for its appeal, which is expected any day. Moreover, no more than eight days after the D.C. court ruling, the Health and Human Services Department (HHS) announced its plans to purchase up to 5 million more doses of the controversial shot from BioPort over the next two years as a means of fattening the nation’s anti-bioterrorism coffers. The same day HHS conjointly awarded an $880 million contract to VaxGen, Inc., of California to manufacture 75 million doses of a new and improved version of the anthrax vaccine. Expected to inoculate 25 million people, this new-fledged injection comes in a three dose regime, a much shinier selling point than the current six dose program. Consistently, the FDA has yet to approve the newly purchased VaxGen vaccine.