November 20, 2000

Vexing Vaccine

The New American
By: William F. Jasper

The Clinton administration is forcing an unproven, experimental anthrax vaccine on the military, risking our soldiers’ health, destroying their morale, and damaging military preparedness.

For Major Sonnie Bates, becoming a pilot in the United States Air Force was the fulfillment of a lifelong dream. Since the age of four, when he first saw the Thunderbirds perform, he knew he was destined to fly. Following graduation from college and ROTC training in 1986, he joined the Air Force and began pilot training. He became a T-37 instructor, teaching others to be jet pilots, and later, in addition to administrative posts and piloting giant C-5 transports, was promoted to training the instructors who train the pilots. After 14 years in the service and 3,200 hard-earned flight hours, the 36-year-old major was looking forward to the continuation of a sterling career. However, last year he was threatened with a court martial and five years in prison for refusing to take the controversial anthrax vaccine mandated by the Department of Defense.

Due to mounting public concern over the issue and congressional pressure, the Air Force dropped the court martial proceedings, but in March of this year Major Bates was given a "general" discharge, which is below an "honorable" discharge. Besides that taint on an otherwise unblemished record, he lost the means of support for his wife and three children. In addition, he was fined $3,200 and charged another $6,000 in payroll penalties. He now works as an aviation instructor for a private company. But Sonnie Bates still harbors dreams of being able to return to the service and camaraderie of the career he loves, that of an Air Force pilot.

Flying is also a passion for Major Thomas Rempfer. After graduating in the top five percent of his class at the U.S. Air Force Academy in 1987, he began the high-octane career of a fighter pilot, flying the F-16, F-117, and A-10 on assignments in Korea, the Middle East, the Balkans, and Central America. In 1998 Major Rempfer transferred to the Connecticut Air National Guard’s 103rd Fighter Wing, continuing to serve as a fighter pilot in the A-10 while beginning a career as a commercial airline pilot. In 1999 he was ordered to resign from the Guard and was transferred to a desk job in the Reserves — for refusing to take the anthrax vaccine. Likewise, Major Russell Dingle, also an A-10 pilot and 19-year Air Force veteran and commander in the same Air Guard unit, has elected to transfer to a non-flying job in the Reserves rather than take the vaccine. Another six pilots followed suit. In all, one-fourth of the Wing’s 32 pilots have ejected, rather than being injected, yet six continue to faithfully serve in non-flying desk jobs despite the millions of tax dollars spent on their flight training.

Technical Sergeant William F. Mangieri is a much-decorated Air Force biological warfare specialist. He received the Bronze Star for his actions in the Gulf War and was twice awarded the Air Force Achievement Medal for his work in NBC (nuclear-biological-chemical) warfare training and preparedness. At 27 he had already been promoted to E-6 and could claim a glowing record. However, his enviable career trajectory came to an abrupt halt on August 24, 1999 — one month before he was scheduled to testify before Congress concerning the serious problems associated with the anthrax vaccine program. TSgt. Mangieri was in the middle of teaching a class when security police were sent to stop and detain him. He was denied re-enlistment in the service and is now on inactive reserve status.

Ruining Readiness

Majors Bates, Rempfer, and Dingle, and Tech Sergeant Mangieri are but a few of the hundreds (or, possibly, thousands) of dedicated, talented, gung-ho armed services personnel who are exiting the military over the anthrax vaccine issue. There are no firm numbers available on the complete scope of this problem, but anecdotal evidence, together with recently released government documents, indicates that it is having an impact on force readiness and morale far greater than the Pentagon has been willing to admit.

An October 11, 2000 report by the General Accounting Office (GAO) noted that its survey of Guard and Reserve pilots and other aircrew members revealed that the "anthrax vaccine immunization program is not widely supported" and "is a key factor affecting individual decisions to change military status." Specifically, the GAO stated: "Since September 1998, an estimated 25 percent of the pilots and aircrew members of the Guard and Reserve in this population transferred to another unit (primarily in a non-flying position), left the military, or moved to inactive status." The anthrax immunization program was cited as the most important factor causing this exodus. Another 18 percent, said the report, indicated "their intentions to leave within the next 6 months."

This massive bailout is no trifling matter. As the GAO report states, "Each of these groups — those who have left and those who plan to do so — had accumulated an average of more than 3,000 flight hours, which symbolizes a seasoned and experienced workforce." In addition, it noted, "it costs the military an average of almost $6 million to train and develop a fully qualified experienced aviator, which the Air Force suggests takes about 9 years." The Air Force and its Guard and Reserve units are not the only ones experiencing a major hemorrhaging of experienced military personnel, but it has been more highly visible and more proportionately devastating here than in the other services.

What does this mean for our national defense preparedness? The GAO report puts it this way:

The reserve components are experiencing difficulties in filling their ranks with new recruits at a time when the DOD [Department of Defense] is relying on them more heavily to support operations around the world. Specifically, the retention of pilots and aircrew members has been and continues to be a problem that could impact readiness. The impact of an exodus of the Guard and Reserve pilots and aircrew members would be significant. Without adequate numbers of pilots and aircrew, the Guard and Reserve could not support the active force in its worldwide operations.

Soldiers as Guinea Pigs

Why all the concern over the anthrax vaccine? After all, members of the military services have been lining up for vaccinations for generations. The above GAO survey found that "most Guard and Reserve pilots and aircrew members support immunization programs in general," but that two out of three service members "reported little or no support for the anthrax immunization." Bates, Rempfer, Dingle, and Mangieri have all received many vaccinations in the past and have never questioned them. Mangieri even received the anthrax vaccine — before he had learned about the risks and problems associated with it.

Critics of the Anthrax Vaccine Immunization Program (AVIP) point to a number of very troubling facts concerning the program:

• Contrary to Pentagon claims, there is no evidence of the long-term safety of the vaccine according to both the General Accounting Office and the Institute of Medicine (IOM). Currently the IOM is attempting to conduct such long-term evaluations.
• The vaccine is considered to be an "Investigational New Drug" (IND) according to two congressional reports, and has not been properly tested for the putative use for which the Pentagon is mandating it be administered — that is, inhalation anthrax infection from biological warfare exposure.
• Under federal law and presidential executive order, as well as FDA and armed service regulations, it is illegal to order military personnel to receive IND vaccines or drugs unless the same personnel have given informed consent in writing. This has not been done.
• The "informed consent" provisions of the law and regulations can be overridden by a presidential waiver for serious national security concerns, but no such waiver has been issued.
• The company which has a monopoly on making the anthrax vaccine has been cited by the FDA for numerous production and safety violations and is now under criminal investigation.
• According to the Pentagon’s own experts, the anthrax vaccine is "unsatisfactory" and "a potential cause for undiagnosed illnesses in Persian Gulf military personnel."
• According to FDA findings, the reported incidence of adverse reactions to the anthrax vaccine is around 50 times (or more) that of other vaccines.
• The Pentagon has not attempted to actively survey personnel for adverse vaccine effects. Moreover, its policies have discouraged reporting on these problems, so the actual incidence of adverse reactions is certainly much larger than the already-alarming numbers.
• Administration, Pentagon, and service officials have repeatedly been caught in serious misrepresentations and outright lies to Congress, military personnel, and the American public on this serious subject.
• The military personnel who are refusing to take the vaccine, or who are leaving the services, are not "rabble-rousers," "slackers," or "malingerers," as some officials claim, but conscientious and valuable assets who are exercising their lawful rights.
• A 1999 study by the Tulane School of Medicine found that exotic antibodies to squalene — a substance added to some vaccines — appeared in troops of the Gulf War era, suggesting a possible link to the mysterious "Gulf War Syndrome" that has plagued many service members.
• After the Pentagon adamantly denied for several years that any squalene was used in the anthrax vaccines, the FDA admitted, on October 3rd of this year, that the chemical was indeed present in the vaccine.
The current vaccine imbroglio was launched in December 1997, when Secretary of Defense William Cohen announced a multi-service vaccination program for all active duty, Reserve, and National Guard service members. The immunization drive began in 1998, but was halted after 400,000 of the nation’s 2.4 million members of the active and reserve forces were vaccinated because the services had depleted the vaccine stockpile and no new supplies are yet available.

The sole supplier of the vaccine is BioPort, a scandal-plagued company that has not been able to restart production because it has repeatedly failed FDA inspections (see sidebar). Despite the infusion of millions of dollars from the Defense Department, the company has been cited by the FDA for sterility and potency deviations, as well as microbial contamination in the vaccine.

More disturbing than these production problems, however, is the fact that even if BioPort or some other producer could manufacture the vaccine according to the Pentagon’s specifications, soldiers would still be facing serious health risks from the vaccine, with little or no benefit in terms of protection against biological warfare agents.

Anthrax (Bacillus anthracis) is a naturally occurring, spore-forming soil bacterium that most commonly affects sheep and cattle, but can also cause death to humans within one to six days of exposure to a lethal dose. Because it is relatively easy and cheap to synthesize, it is considered a likely biological warfare (BW) agent to be used against the United States by terrorists as well as enemy states. As a BW agent, the anthrax spores would most likely be dispersed into the air to be inhaled by either military or civilian populations.

The 1970 license for the anthrax vaccine indicates that it was approved only against cutaneous (skin) exposure to anthrax for a specific methodology of administration, and a specific vaccination schedule. It was intended as protection for agricultural workers and has not been approved for pulmonary (inhaled) anthrax.

Concerning the anthrax vaccine, Army Surgeon General Ronald Blanck stated in 1994 that "its safety, particularly when given to thousands of soldiers in conjunction with other vaccines, is not well established." In the same briefing to Senate Committee staff, Gen. Blanck averred that the vaccine "should continue to be considered as a potential cause for undiagnosed illnesses in Persian Gulf military personnel."

This negative view is supported by the testimony of other experts, such as Dr. Arthur Friedlander, head of bacteriology at Ft. Detrick and co-author of the medical textbook Vaccines. In that work, Friedlander concluded: "The current vaccine against anthrax is unsatisfactory for several reasons. The vaccine is composed of an undefined crude culture supernatant adsorbed to aluminum hydroxide." "No direct determination of the content or structure of the protective antigen in the vaccine has been made," he continued, "and it is unknown whether the protective antigen is biologically active." Finally, he observed, "The undefined nature of the vaccine and the presence of constituents that may be undesirable may account for the level of reactogenicity [the capacity of a vaccine to cause adverse reactions] observed."
Senate Staff Report 103-97, a 1994 report by the Senate Veterans Affairs Committee under the chairmanship of John D. Rockefeller IV (D-WV), states: "Although the results of this study suggest the vaccine might protect against anthrax that has been sprayed, it is not sufficient to prove that anthrax vaccine is safe and effective as used in the Persian Gulf. The anthrax vaccine should therefore be considered investigational when used as a protection against biological warfare."
According to the product insert warning included with the vaccine: "Studies have not been performed to ascertain whether anthrax vaccine absorbed has carcinogenic action, or any effect on fertility."

In an April 1998 letter, Dr. Kathryn Zoon of the FDA noted that "data for clinical studies conducted on the long term health effects of taking the anthrax vaccine have not been submitted to the FDA."

Dr. Kwai-Cheung Chan, director of applied research and methods for the GAO, testified on April 29, 1999 that "the long-term safety of the vaccine has not yet been studied."

Before initiating the AVIP, Secretary Cohen declared that there would be "supplemental testing" and an "independent expert review" of the vaccine. Neither of these has taken place. As it turns out, the Yale University doctor whom the Defense Department had repeatedly cited as their "independent expert" is an obstetrician and gynecologist. When summoned to testify before Congress, this physician informed the legislators that he had "no expertise in anthrax" and that he had also informed the Pentagon of this same deficiency before he was hired to do their "independent expert review." Little wonder that servicemen like Major Rempfer consider the review "a sham."

The sole production facility for the anthrax vaccine was originally owned by the Michigan Department of Public Health. In the mid 1990s the facility was sold to a company known as MBPI (Michigan Biologic Products, Inc.). MBPI, in turn, was sold to BioPort in 1998.

On September 20, 1996, MBPI filed an Investigational New Drug (IND) application with the FDA for the anthrax vaccine. The AVIP record is replete with references to the vaccine’s IND status.

As such, the vaccine’s use as pertains to the military falls under 10 U.S.C. § 1107, entitled "Notice of Use of an Investigational New Drug or a Drug Unapproved for its Applied Use." This federal statute specifically states: "Whenever the Secretary of Defense requests or requires a member of the armed forces to receive an investigational new drug or a drug unapproved for its applied use, the Secretary shall provide the member with [a] notice" containing specific information. That information, which must be provided before administration of the drug, includes:
1. Clear notice that the drug being administered is an investigational new drug or a drug unapproved for its applied use.

2. The reasons why the investigational new drug or drug unapproved for its applied use is being administered.

3. Information regarding the possible side effects of the investigational new drug or drug unapproved for its applied use, including any known side effects possible as a result of the interaction of such drug with other drugs or treatments being administered to the members receiving such drug.

On September 30, 1999, President Clinton issued Executive Order 13139, entitled "Improving Health Protection of Military Personnel Participating in Particular Military Operations." That order, among other things, mandates: "Before administering an investigational drug to members of the Armed Forces, the Department of Defense (DoD) must obtain informed consent from each individual unless the Secretary can justify to the President a need for a waiver of informed consent in accordance with 10 U.S.C. 1107(f)."

In addition to the federal statute and President Clinton’s own executive order, Lt. Col. John J. Michels Jr. and Major Bruce Smith, the attorneys who successfully protected Major Bates from imprisonment, point out that Air Force Instruction (AFI) 40-403, "Clinical Investigations in Medical Research Guidance and Procedures," very explicitly spells out the right of Air Force personnel to receive detailed information about the possible side effects of all investigational drugs and therapies, and specifies that each member must then give his or her consent in writing, before being subjected to any regimen. On the basis of the law and regulations, Michels and Smith compellingly argue that the mandatory anthrax vaccinations are illegal, as are the penalties being meted out to hundreds of service personnel.

Numbers Games

Although no one claims to know with certainty how many military personnel have suffered adverse reactions to the vaccine, how many have been penalized for refusing to take it, and how many have fled active duty or transferred to avoid taking it, there is very good reason to be skeptical of the Pentagon’s lowball estimates in each of these categories. The Defense Department has steadfastly held to the increasingly ludicrous party line that the numbers in all of these areas are so "minuscule" as to be insignificant.

Testifying before the House National Security Subcommittee on September 29, 1999, Major General Paul Weaver Jr., director of the Air National Guard, brushed off concerns about an exodus, saying, "when I hear all these other figures about these mass resignations and whatnot, they’re just not there." Critics disagree. The GAO report cited previously, together with information gleaned from news stories nationwide and memos from various military bases, paints a decidedly different picture. A year earlier, Weaver had received a memo from Col. Walter F. Burns, commander of the Connecticut Air National Guard, concerning the "flood of questions [and] concerns" about the vaccine and the "very real possibility" that he could lose one-third of his A-10 pilots in the 103rd Fighter Wing. Soon after that, the anthrax vaccine did cause the loss of one-fourth of his pilots.

And Col. Burns was not the only commander facing this predicament. According to an investigative report by the Baltimore Sun in October 1999, "more than 50 percent of pilots in some Air National Guard squadrons are resigning or seeking nonflying jobs." It reported, for instance, that "22 of 48 pilots within a squadron of the Tennessee Air National Guard" had sent letters of resignation, "all of them citing the vaccine and their worries that it is neither safe nor effective against the deadly biological agent." "We lost 50 percent of our pilots; we can’t possibly be ready," said Capt. Michael Pulsifer, one of the departing pilots. "They can play all the word games they want."

A memo from Travis Air Force Base in California lists one 58-pilot squadron losing 32 pilots, with 20 of them citing the vaccine. "At Dover Air Force Base in Delaware," reported the Sun, "23 of 58 C-5 cargo pilots are leaving from the 709th Reserve Squadron, with 29 pilots out of 60 in the 326th Reserve Squadron." "There’s never been an exodus like this before," the Sun quoted Major Jim Pryzgocki, one of the departing pilots, as saying.

Lieutenant Colonel Thomas Heemstra, a former squadron commander in the Indiana Air National Guard, told a congressional committee that the anthrax vaccine program had "devastated our unit."

According to Major Tom Rempfer, senior Defense Department leadership is obfuscating vaccine-related attrition, despite subordinate commanders’ attempts to provide the data up the chain of command. He added that even the deputy secretary of defense, in testimony to the House Armed Services Committee on September 29, 1999, maintained losses are not being tracked because it may undermine commanders. This convoluted claim was made despite evidence that a Pentagon investigative team was tracking significant losses as early as March of 1999. In his case, says Rempfer, "A Pentagon spokesman misled lawmakers and the media by underreporting our losses and suggesting that some of us had left for family and personal reasons instead of the anthrax vaccine, implying that we had refused the vaccine because we were unwilling to deploy overseas. In fact our unit Commanders had communicated to their chain of command that all eight departed over the anthrax vaccine dilemma."

Further refuting the Defense Department’s propaganda and rhetoric, Major Russell Dingle maintains that the mounting evidence shows adverse reactions to be far more common than has been reported. Dingle was tasked by his Wing Commander to lead a research effort into the vaccine and to pass concerns up the chain of command. He points to the March 24, 1999 and the October 3, 2000 testimony by FDA officials before the House National Security Subcommittee and the Government Reform Committee concerning VAERS (Vaccine Adverse Event Reporting System) reporting numbers. The FDA reported a dramatic increase from 42 adverse reactions by March 1999 for 634,000 shots, to 1,561 reactions for nearly 2,000,000 shots given by October 2000 to about 500,000 service members receiving the partial vaccination series. "Put in context, this tripling of vaccinations caused an almost forty-fold increase in reported adverse reactions. These adverse reaction rates are almost fifty times the annual VAERS rate when compared to all vaccines administered to the population at large," he says. As a reference Major Dingle points to the FDA’s testimony on July 21, 1999 where FDA officials admitted that only 11,000 to 12,000 VAERS forms are filed annually nationwide for a population of 250 million Americans.

Even those astounding numbers would still tend to undercount the true adverse reaction incidence, says NBC specialist William Mangieri. "VAERS is a passive reporting system and does not even begin to accurately reflect the true picture." He and other critics point out that many military physicians have never even seen a VAERS form and there is no genuine effort to promote the reporting program. Moreover, they note, the military culture militates against complaining or appearing wimpy, so many service personnel will simply ignore symptoms that should be reported through VAERS. In addition, those who are feeling adverse effects often conceal them in order not to jeopardize their military careers or civilian jobs.

Perhaps the biggest casualty in the anthrax fiasco is the "trust factor." "This breach of trust by our top military leaders — their lack of leadership and failure to do what is right — has probably done more damage than the vaccine itself," Major Sonnie Bates told THE NEW AMERICAN. "That trust is essential in the Armed Forces, and it has been terribly damaged.... I hope that Congress will take the actions necessary to help restore that trust and right the wrongs that have been and are being done." Major Rempfer adds: "The only thing that ever should have been forced out of the military in this tragedy is this dishonorable policy and questionable vaccine."

A $hot in the Arm for BioPort

Since its start-up in 1998, BioPort Corp. has been nearly as controversial as the anthrax vaccine it produces. From the get-go there were serious concerns and accusations of underhanded financial dealings and corruption. Because of repeated failure to pass Food and Drug Administration (FDA) inspections, the Lansing, Michigan company has yet to produce a dose of anthrax vaccine for U.S. troops. Nearly 500,000 members of the armed services have received at least one dose of the vaccine, but those have all come from stockpiles that BioPort had on hand from Michigan Biologic Products Institute, which BioPort bought in 1998.

On September 27, 2000, BioPort was handed another major blow: the first death linked to its vaccine. Ionia County Chief Medical Examiner Dr. Robert Joyce said an autopsy of BioPort lab worker Richard Dunn showed Dunn had an "inflammatory response" to the vaccine throughout his body. Dunn, who died July 7th, had received 11 doses and had complained of joint pain, fatigue, and swelling before his death. Although the autopsy does not directly claim that the vaccine was the cause of Dunn’s death, it adds to the mounting concerns over the vaccine.

At the center of the troubled company is Retired Admiral William J. Crowe Jr., a former chairman of the Joint Chiefs of Staff, who owns a controlling interest in BioPort and sits on the company’s five-member board of directors. Critics have been suspicious of Crowe’s role in promoting the Clinton administration policy to mandate the dubious vaccine, especially since Crowe’s company holds a monopoly on the production of the drug.

According to a Pentagon audit completed earlier this year, BioPort forecasted a possible $18 million loss for this year. Its original contract had the company selling the vaccine to the Pentagon for between $2.26 and $4.36 per dose, depending on the year of manufacture. The vaccine regimen calls for six doses and an annual booster. But last year BioPort more than doubled the price to $10.64 a dose as part of a deal that raised the Pentagon contract by $24 million, including an $18 million advance to help keep the company solvent.

"I believe we have a skunk, I just can’t find out where the odor is," said Rep. Walter Jones Jr. (R-NC) in a news interview. Jones, a member of the House Armed Services Committee, and a critic of the vaccine program, requested an investigation of the Pentagon’s financial relationship with BioPort by the Defense Department’s inspector general.

Other critics point to Admiral Crowe as one of the skunks, if not the skunk, in the BioPort works. "If Crowe is involved in this you know it’s fishy," a former top Pentagon official who requested anonymity told The New American. "It looks like another payoff for his help to Clinton." It was Crowe’s endorsement as former Chairman of the Joint Chiefs that came at the critical moment to save Bill Clinton’s first presidential bid. Crowe’s on-camera support did much to offset Clinton’s draft dodging and anti-military record. Crowe was rewarded with appointment as ambassador to England, a highly prized political plum. Was the BioPort anthrax contract another payoff? It sure looks that way.