A Dose of Reality

By Timothy W. Maier

They call themselves the "walking dead" - not a comforting thought, considering they are members of the U.S. Army, Navy, Air Force, Marines and National Guard. But some feel nearly dead - or that they might become medically disabled in the long run - after being ordered to receive anthrax vaccinations in the new campaign to vaccinate 2.4 million enlisted and career personnel.

Critics point to the unknown impact of inoculations with a serum never used on such a massive scale, the Pentagon's refusal to consider long-run side effects, the impact on differing immune systems and the ability of an enemy to alter the biological agents of anthrax to strains unaffected by the vaccine. As a result, scores of enlisted personnel have accepted courts martial and jail terms rather than receive the shots, and a disturbing number of highly trained reserve pilots have decided to resign - specifically citing the risk.

A number of those vaccinated already have been injured, and their stories are troubling. From 1990 to July 1, 1999, 215 reports of adverse events involving civilians and soldiers were reported to VAERS, the Communicating Vaccine Adverse Event Reporting System of the Food and Drug Administration, or FDA. Of these, five patients were hospitalized for severe injection-site reactions, one experienced an allergic reaction, another suffered a case of aseptic meningitis and two were diagnosed with Guillain-Barr syndrome - putting them in wheelchairs - and another with bipolar disorder. One patient experienced the onset of lupus and has not recovered.

Since the FDA posted the VAERS results, the Anthrax Vaccine Expert Committee, an independent review team comprising civilian doctors, met Aug. 10 to review 157 VAERS reports concerning only soldiers observed March 1998 to August 1999. Of those, 15 soldiers were hospitalized for events ranging from injection-site injuries to multiple sclerosis and diabetes. Again, the review team declared that only systemic reactions such as cold sweats, chills, aches, rashes, itching, chest tightness and allergic lung reaction might be related to the vaccine. All other pathologies were disregarded.

But tell that to the walking dead. Air Force Capt. Michelle L. Piel, a pilot, told the House Government Reform subcommittee on National Security, Veterans Affairs and International Relations in July about her fatigue, dizziness and immune disorders. "There is no way that I know of to prove that the anthrax vaccine causes any of this," she claims. "All I can tell you is that I became uncharacteristically ill after I started taking the anthrax shots. It has taken 12 doctors and eight months for me to finally find any reason for my symptoms."

The Pentagon says to look at the statistics. As of Aug. 11, 323,496 military personnel have taken the first of six mandated shots; only 200 refused. "There is no widespread fear," insists Department of Defense spokesman Jim Turner, who takes issue that there has been a backlash of complaints or side effects related to the shot.

Are all the complaints reported? Piel says she doubts it. "The chief flight surgeon did not agree that I'd had a reaction to the vaccine. When I asked what he considered reportable, he gave me examples such as difficulty breathing, rashes, sweating, fever, nodules and anaphylactic shock. All of these are classic allergic reactions. My case did not fall into those criteria."

So far, all the injections came from stockpiles prepared by the sole-source and now-defunct producing laboratory, the Michigan Biological Products Institute, or MBPI, then owned by the state of Michigan. But MBPI, which had been experiencing funding and quality-control problems, has been sold to a biotech start-up, BioPort Corp., controlled by the former chairman of the Joint Chiefs of Staff, retired admiral William J. Crowe Jr., and Faud El-Hibri - a biologist of Middle Eastern origin who has facilitated sales of anthrax vaccine to Saudi Arabia - and former employees of MBPI (see related story, p. 13). Moreover, BioPort has not produced any vaccine because the corporation still is waiting for FDA approval of its new lab. This situation doesn't sit too well with the Reserve Officers Association, which favors the mandatory inoculation as long as fresh vaccine is used.

Turner sent Insight a summary of medical studies - all suggesting the anthrax vaccine is safe and effective since the FDA licensed it in 1970. One of these, the so-called Licensure study, produced when the vaccine was up for approval before the FDA, shows that systemic reactions, such as malaise or chills, were reported in four individuals or fewer than six per 10,000 doses of the vaccine. Another, the Brachman study, involving mill workers, shows that systemic reactions occurred in fewer than two per 1,000; a Fort Detrick study involving 999 male laboratory workers who were followed up for 25 years shows that none of the men developed any unusual diseases or unexplained symptoms.

Critics says those studies are flawed, noting that the Fort Detrick study did not even support a control group. Meryl Nass, a member of Physicians for Social Responsibility, or PSR, and a physician at Parkview Hospital in Brunswick, Maine, says she doubts the vaccine will work. While a controlled trial that would subject humans to inhalation of anthrax is unethical, scientists have forced monkeys and guinea pigs to inhale anthrax with contradictory results. A Fort Detrick experiment using guinea pigs showed nine of the 27 strains tested killed 50 percent of the vaccinated guinea pigs. In a second study, 26 of 33 strains tested killed half of the animals.

Such studies prompted the Senate Veterans Affairs Committee in 1995 to declare the vaccine should be considered "investigational when used as a protection against biologic warfare." Nass also points to a series of studies suggesting reaction rates are much higher than the Pentagon has led troops to believe. A Korean study shows rates of all reactions from minor to severe were 40 percent in men and 70 percent in women. The ongoing Tripler Army Medical Center study of 600 service members resulted in 20 percent of vaccinated soldiers developing a systemic reaction after at least one of the first three injections. At Dover Air Force Base, 20 to 25 pilots have been identified with symptoms similar to those present in people with the so-called gulf-war illness, with 50 percent reduction in function.

Where lies the truth? It simply may not be known. Today no long-term studies exist of the anthrax vaccine. As some of the dissenters see it, maybe you'll get sick, maybe you won't. Dover Air Force Reserve pilot Hans Reigle, who submitted his resignation, says, "They're asking us to put a gun to your head as a matter of faith and pull the trigger. Hopefully there is more than one empty chamber."

Turner says to look at the alternative: "We fight as a team. If you don't have the anthrax shot, your team is degraded. You're not combat-ready. We make it mandatory for a variety of reasons. One is to save people's lives. No. 2 is to maintain an effective fighting force. And three, it takes weapons away from our enemies. It is a verified threat. If you vaccinate our people, you take the weapons out of their hands."

The military takes away choice, but House Government Reform subcommittee on Veterans Affairs Chairman Christopher Shays of Connecticut characterizes it as a profoundly personal choice. "After military service, the uniform comes off but the anthrax vaccine stays with you for life. It's just not the commitment many dedicated men and women made to their country when they volunteered for military service."

At the center of the debate is broken trust, he says. "Radiation testing, Agent Orange, the reckless use of experimental drugs and the mysterious gulf-war illnesses have made military men and women understandably distrustful of the Pentagon on medical matters," Shays says.

This private dogfight has evolved into ugly personal attacks. Because of Nass' ties to PSR, he is considered an antiwar protester and a member of the no-nuke club and therefore politically motivated to distort the facts. Likewise, Crowe, who is a director of BioPort, has been questioned about his profit motives. BioPort has made no secret that to make long-term profits, the company must be able to market the vaccine to foreign countries and not just the military - which raises concern among soldiers who fear that the wrong country could get the code and build a strain to defeat the vaccine.

Tech. Sgt. Bill Mangieri is the first nuclear biological chemical warfare instructor from the 105th Air Wing in Newburgh, N.Y., publicly to refuse the shot. "I reviewed the studies and I don't believe the vaccine will work," he says. "We don't need to get in the business of the inoculation race. The wrong people get it and they can change the code."

Republican Rep. Walter Jones Jr. of North Carolina, a member of the Armed Services Committee who has called for an investigation into BioPort's financial ties to the Pentagon, charges the military has done a poor job of educating its servicemen and women and now appears to be playing catch-up to avoid a mutiny. Jones has introduced a bill, HR2543, the American Military Health Protection Act, calling for the inoculation to be voluntary. His colleague, New York Republican Rep. Benjamin Gilman of New York, chairman of the International Relations Committee, has introduced another bill, HR2548, the Vaccination Moratorium Act. which would halt all vaccinations until a long-term study by the National Institutes of Health can be completed.

To ameliorate Jones' fears, Cohen wants Jones to meet with the Pentagon's anthrax experts. To that suggestion, Jones says, he replied, "I'm not your problem. The military is your problem."

"At Travis Air Force Base alone, 32 pilots in the 301st Airlift Squadron have resigned or are planning to resign because of the vaccine," Jones tells Insight. "That is more than a 50 percent attrition rate. The Air Force estimates it costs $6 million to train a pilot. If that holds true, the United States is losing over $190 million worth of training and over 450 years of combined experience in the cockpit."

The Sun of Baltimore recently reported that 25 F-16 pilots of the 35 pilots in the 122nd Fighter Wing of the Indiana National Guard are refusing the vaccination - resulting in the entire squadron being grounded. Another one-third of the F-16 pilots in the Wisconsin National Guard's 115th Fighter Wing also plan to refuse injections as well as one-third of the pilots in the Air National Guard unit in Connecticut. One chief pilot describes the situation: "Morale is at an all-time low, and anthrax is the last straw."

Reigle, who stands to lose about $12,000 per year as an instructor for the C-5, the Air Force's largest plane, says 21 in 57 pilots are leaving his squadron at Dover, Del. "That's more than $100 million walking out the door." When pilots do leave, there is not much concern about the cost factor, adds another pilot. "What there telling us is don't let the door hit you in the ass."

Mangieri says New York's 105th Air Wing stands to lose about 200 people because of the antianthrax program. "It will be the largest voluntary departure of any single military unit in the world.i The program is so unpopular with the troops that it may cause a serious readiness problem in the very near future."

Air Force spokesman Lou Timmons disputes that charge. "As of today, readiness levels within the Air Force Reserve are well within acceptable levels and our units are more than capable of performing their wartime missions."

From 1996 to 1998, the Air Force lost 369 pilots. This year alone they already have lost 139 in resignations. Timmons says the departures are based on a variety of reasons - high operational tempo (Pentagon jargon for frequent peacekeeping stints abroad, with little shoreside rest in between), turbulence associated with short-notice tasking and its impact on work and families, increased airline hiring, aircraft conversions and the drawdown of Reserve C-141 units. "This command is committed to protecting its members from all known threats, to include anthrax," he adds. "We are being very proactive in trying to address the concerns and questions of our members and will make every reasonable effort to resolve them. In the end, however, we will not deviate from the requirement for all personnel who require the anthrax vaccine to receive it and those who choose not to comply will be separated."

Insight since has learned that the number of Air Force Reserve resignations for 1999 could reach 340 when the paperwork is processed in mid-September. Many tracking the numbers have remained mute because of what happened to Debra J. Egan, an Air Force pediatric nurse who, in a letter to the military newspaper Stars and Stripes, raised concerns about the vaccine's side effects, its possible impact on fertility and its usefulness against the airborne anthrax spores. Her superiors slapped her with a written reprimand and denied her a commendation medal after a four-year tour in Okinawa. "People need to know it's not safe to write letters and express your opinion unless it's the same opinion that the Air Force has," she told the Washington Post. "I guess if they want us to have an opinion, they'll give it to us."

However, the Air Force claims, it is not what Egan said but the fact that she is using her position and office to support her opinions. The military authorities say that if she would have dropped her rank and affiliation with the Air Force, then she would be free to speak as a private person.

Army Pfc. Matthew Baker, who left his post at Fort Stewart, Ga., put it this way in a letter to the Army surgeon general: "I indicated my concerns about being given the anthrax vaccine and was told by my first sergeant that if I refused to submit to an anthrax vaccine hypodermic shot, I would be strapped down to a gurney and would forcibly be injected against my will."

While that has not happened yet, more than two dozen soldiers from the Marines to the Navy have been prosecuted. The Air Force reports 48 courts-martial since 1998 for anthrax refusal. As of today, 14 Marines in Hawaii and another dozen in California are waiting courts-martial and dishonorable charges for refusing to obey the order. More recently Zachary Johnson, an aviation electronics technician for a naval air station in Jacksonville, Fla., faces a court-martial for refusing the vaccine. Those who tested the courts have received felony convictions of bad conduct resulting in 30 days in a military jail and subsequent discharge. If they choose to stay in the military and refuse the shot again they could face five years in jail.

Jeffrey Jeffords, a National Guardsman in Memphis who served in the Persian Gulf War, since has requested a transfer to a position where the shot is not required. Worried about losing $500 a day as a commercial pilot if he ends up becoming one of "the walking dead," he says, "It's not worth the risk. My family is first, my civilian job is second and the reserves are third."

The Pentagon finally is going to take that look at it. On July 29, the Pentagon's Anthrax Immunization Program convened a team of civilian and military experts to design a long-term study. Another study at Fort Detrick involving 570 volunteers is under way to remove fear, doubt and perhaps silence critics such as Jones, who wants hearings held and answers now. But it's not stopping the congressman. "I'm like an old bulldog with a bone," he says. "It's hard to get it out of my mouth until I'm through chewing it."

WHAT'S GOOD FOR THE GOOSE?

To counter the critics, the Pentagon public-relations shop shows films of military leaders taking antianthrax inoculations. Even Defense Secretary William Cohen happily has rolled up his sleeve in front of the cameras, smiling as the stuff goes in. President Clinton himself is believed to have been vaccinated for anthrax, although no one will confirm the fact, claiming it's classified. Retired admiral William J. Crowe Jr. has taken three of the six required shots - and he is the former chairman of the Joint Chiefs of Staff and a director of BioPort, which bought the producing laboratory, the Michigan Biological Products Institute, from the state of Michigan in 1998.

While Crowe declined repeated requests for interviews, his chief spokesman, Jay Coupe, says, "Do you think the admiral would subject himself or the military to a shot if he didn't believe it was safe?"

Coupe downplays the critics, saying that they're mostly "just reservists." He adds, "Do you think they have the intelligence of the secretary of defense, who has taken the shot, or Admiral Crowe, who has 50 years of military service? Let me put it another way. Who do you think would have more access to more information? The secretary of defense or a pilot? You should look at the motives - some of these pilots may not want to be deployed."

PENTAGON SAYS YES, STATE SAYS NO

In December 1997 the Pentagon announced all 2.4 million active-duty military personnel and reservists would be inoculated against anthrax. President Clinton warned Americans that a terrorist attack likely would occur after the United States bombed a suspected pharmaceutical terrorist facility in Sudan.

Defense Department spokesman Jim Turner dispels allegations that the Pentagon jumped too fast into the vaccination business. First, he says, look at the alternative: Death is the predictable outcome of inhaling anthrax. While not contagious, the inhalation of anthrax spores causes severe respiratory distress, followed by shock and then coma. "Detection is very difficult," Turner says. "It's highly unlikely you know you are attacked because the symptoms are flulike. About the time the symptoms start showing, you're dead."

There was no overnight decision, he insists. It took at least "one or two years of thought" behind this undertaking. "It's a vaccine that has been safe and effective for 30 years. It would be unconscionable for us not to do it." Perhaps, but what is the most likely target a terrorist would strike? A military base or a U.S. embassy, asks Washington attorney Mark Zaid.

Certainly history suggests that an embassy is subject to a terrorist attack, so it would follow logically that the State Department would mandate the anthrax vaccine to those in at-risk countries. But State doesn't do that. Zaid points out that State's policy is to make compliance strictly voluntary, just as it is in Britain. "The Pentagon says it is unconscionable not to do it," he says. "Well, how immoral are those British people? They stopped their program. There is no program in France and no such program with the Israelis. They rely on protective gear. The State Department is at risk. Why aren't they doing it?"

When Insight asked the State Department to respond, spokesman Philip Reeker said, "The Department doesn't mandate any vaccines. We provide them with information to make their own decision."

When told of their remarks, Rep. Walter Jones Jr., a member of the House Armed Services Committee, immediately fired off a letter to Secretary of State Madeleine Albright requesting copies of all documents, files, memoranda, electronic communication and faxes pertaining to the State Department's decision. "This inconsistency between departments is baffling - and wrong," Jones wrote. "Since State Department employees are more widely dispersed, and thus more widely exposed to a potential anthrax threat, the logic of your voluntary anthrax program underscores the illogic of the DOD position."