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Posted on Mon, Jul. 25, 2005
http://www.kansascity.com/mld/kansascity/12214696.htm? (must register to view original article)
Anthrax vaccine under fire
Refusal rate concerns military; troops speak out
By DAVID GOLDSTEIN
The Star's Washington Correspondent
WASHINGTON –– Shonya McBride remembers very clearly the night she rolled over in her sleep and her hand fell across her husband's chest. She awoke with a start.
"His heart was just pounding out of his chest," she said. That was in 1999, after Travis McBride, a 22-year-old Marine Corps sergeant, had received the second of six mandatory inoculations of the anthrax vaccine.
By the fourth shot, he had developed serious heart problems, chronic fatigue and severe joint pain. McBride never made it to the fifth. Within a year, he was medically discharged.
He had been ordered to take the shots, like probably hundreds of military men and women who believe the vaccine boomeranged and made them seriously ill.
"If I had had the option, I wouldn't have taken it," said McBride, now 28 and an Atchison County sheriff's deputy.
For the past two months, however, incoming military personnel have had the option of not taking the anthrax vaccine, as a result of a federal lawsuit won last year by some military personnel who objected.
For now, instead of being threatened with courts-martial and dishonorable discharges, soldiers are told the shots are voluntary.
As a result, half of the military and civilian Defense personnel asked since May to take the shots have declined, according to the Pentagon.
The refusal rate worries the military, which many believe would like to reinstate the mandatory rule for all active duty personnel and reserves.
"That means that half of our (newest) troops could be harmed in an enemy attack and possibly die," said Marianne Coats, a spokeswoman for the Military Vaccine Agency. "This concerns us very much indeed."
Vaccine critics said the situation is an improvement.
Mark Zaid, an attorney involved in the lawsuit, said that much progress has been made since the days of military courts-martial, but added that it remains subjective whether the vaccine being voluntary is a good thing.
What concerns Zaid and other critics is that the anthrax information brochure that the military hands out contains none of the information that comes packaged with the vaccine about risks and medical reactions possibly linked to it.
Beyond the more common nausea, fever and chills, other medical problems possibly linked to the vaccine, according to the manufacturer's insert, include multiple sclerosis, encephalitis, leukemia, blood clots, nervous system disorders, lymphoma and immune deficiencies.
"The Defense Department does not wish for troops to even know the dangers explained on the vaccine's own label," Zaid said.
Col. John Grabenstein, director of the Military Vaccine Agency, said in an e-mail response to a series of questions that since 1998, the military has provided "detailed educational programs" to explain the anthrax vaccine.
The Pentagon and the Food and Drug Administration insist that the vaccine, which has been given to about 1.3 million military and some civilian personnel since 1998, is safe and effective.
Citing a 2002 National Academy of Sciences study, Grabenstein said that the anthrax vaccine posed no greater risk of serious health problems than any other vaccine.
But some former soldiers, outside experts, military activists and other supporters do not think that is accurate.
Former Master Sgt. Dennis Brewster of Augusta, Kan., was diagnosed with an array of medical ailments after the shots, including chronic, widespread joint pain, chronic headaches, chronic fatigue and irritable bowel syndrome.
"I knew how I was before the shot, and I got the shot and I know what happened to me," he said.
No informed consent
The anthrax vaccine has been controversial almost from the beginning.
The FDA licensed it in 1970, but only for anthrax exposure through the skin because the disease was largely confined to the livestock industry.
No human testing of its effectiveness had been done. The testing that was performed, in 1962, was on a different version of the vaccine. The manufacturing process had changed by 1970 when it was licensed.
The vaccine was never approved to protect against anthrax inhalation, which is how troops would encounter the toxin on the battlefield and why the military forced soldiers to be vaccinated.
Still, the Pentagon used it to vaccinate certain units against anthrax before the 1991 Gulf War because of fears that Iraq had biological weapons. Since then, researchers at Kansas State University have found a possible link between the vaccine and the series of mysterious maladies known as Gulf War Syndrome experienced by many veterans of that conflict.
In 1997, as concern heightened about troops deployed to the Persian Gulf and Korean peninsula, the Pentagon made the vaccine mandatory. The regimen was a series of six doses over 18 months, with annual boosters.
The threat of anthrax as a battlefield weapon is probably greater in North Korea than anywhere else, according to Jonathan Tucker, a chemical and biological weapons expert at the Center for Nonproliferation Studies at the Monterey Institute for International Studies.
"I'm not familiar with any evidence that the (Iraq) insurgency or the Taliban has access to anthrax," he said. "North Korea is assessed to have a biological weapons program, and anthrax would probably be an agent in its arsenal."
Meanwhile, the sole manufacturer of the vaccine, the BioPort Corp. of Lansing, Mich., has been cited several times by the FDA for quality control problems.
The military shut down the vaccine program last fall when a federal judge ruled in favor of six anonymous former and current Defense Department employees who alleged that the vaccine was being used in a way for which it had not been licensed and should not be forced on anyone.
The government has appealed the ruling. In the meantime, the Pentagon began the voluntary inoculations in May under an emergency-use authority, citing a high bioterrorist threat.
`Blind eye' alleged
Six years after taking the vaccine, McBride's heart problems shadow his family's every move. When he takes his 5-year-old son fishing, he and his wife make sure the child remembers how to dial 911 in case his father has a problem.
At the time, refusing the order to take the vaccine wasn't an option. He loved being a Marine and hoped to make a career out of it.
"I was an enlisted serviceman," he said. "I was told to jump; you asked, `How high?' I was just doing what I was ordered."
So was Army Sgt. Sandra Larson of Spokane, Wash. In 2000, three months after receiving her final shot while assigned to Fort Riley, Kan., she died of a rare blood disorder at the age of 32.
"It was as if there was something in her that was killing her immune system, shutting her down," her sister, Nancy Rugo, told a congressional committee after her death.
Between 1990 and 2004, 16 people died after taking the vaccine, according to the government's Vaccine Adverse Event Reporting System. Most suffered heart, lung and immune system problems, and cancer.
All but five were dead within three months of their last vaccination. In addition, the reporting system shows that nearly 4,500 other recipients have had medical reactions, with nearly 8 percent listed as "serious," meaning the problems were life-threatening, required hospitalization or resulted in a major disability. The reports are submitted by vaccine recipients and providers, relatives, health-care givers and others, but are not necessarily inclusive of everyone who has had a reaction.
The Institute of Medicine, a division of the National Academy of Sciences, called the vaccine reporting data "useful as a sentinel for adverse events." But it cautioned that the reports might be "underreported, incomplete, or duplicative," and that the claims are not always verified by medical officials.
Grabenstein said that anyone who becomes sick after a vaccination "deserves the best care we can give them, whether a vaccine is the cause of their health problem or not."
But Meryl Nass, a Maine internist and leading critic of the vaccine, said the military had turned "a blind eye" to the risks. She has examined numerous vaccine recipients with serious illnesses, including several who served in the Kansas Air National Guard.
"The people who become disabled more often than not have multiple diagnoses," Nass said. "They also, more often than not, have syndromes that are rare or nonexistent in the patients that doctors normally see. Their bodies are not doing what they're supposed to be doing."
Leaving the big B-1 behind
Worries began to seep through the military ranks within two years of the start of the vaccine inoculations.
Pentagon reports show that between 2000 and 2004, 149 service members refused the vaccine.
Some were court-martialed for refusing an order and given bad conduct discharges. About a dozen cases are in stages of appeal.
In a 2002 study, the General Accounting Office surveyed Air National Guard and Air Force Reserve aircrews and found that 16 percent of more than 800 airmen who responded had either transferred, become inactive or left the service between 1998 and 2000 to avoid the shots. An additional 18 percent said they planned to leave soon.
The GAO, now known as the Government Accountability Office, also found that about 84 percent of the pilots and crew members who took the vaccine during that period experienced side effects or adverse reactions, a rate more than double what the manufacturer claimed at the time.
In addition, the study found that about 24 percent of those reactions were systemic — meaning that they affected their entire bodies. That was "more than 100 times higher" than what the manufacturer estimated, the GAO said.
The military ordered former Maj. David Towne, who flew for the 128th Bomb Squadron of the Kansas Air National Guard, to take the shot in 1999. Towne was torn because he loved flying the big B-1 bombers, but worried about developing health problems and jeopardizing his civilian career as a commercial pilot.
"I wear a bicycle helmet, I wear my seat belt. I just decided it was not worth it for me to take it," he said. "They told me I was unpatriotic and would regret this for the rest of my life. They questioned my integrity."
Towne, who is 39 and now lives in Ohio, offered to resign but received a general discharge instead. He has appealed.
"These are people who volunteer their lives and livelihood to protect America," said Peter Martuscello of Wichita, a 57-year old former Kansas Air National Guard technical sergeant who was medically discharged after taking the vaccine. He developed Guillain-Barre Syndrome, an immune disorder, and other problems.
"To dump on people like that is crazy," Martuscello said. "That's the sad part. They gave you no option."
And no information on possible risks, according to several former soldiers who took the vaccine and became ill.
Brewster said that when his unit in the 184th Bomb Wing of the Kansas Air National Guard got a briefing about the vaccine in June 1999, "They didn't tell us about any risk. They gave us the basic standard speech," he said. "They said there was some talk out there, but it was all Internet hype."
A week after receiving the first shot, Brewster started feeling like he had the flu. Then a powerful fatigue came over him. His ankles, knees, shoulders, elbows and hands all began to hurt. He also got severe headaches. By the fourth shot, his health had further deteriorated. He was in and out of the hospital for intestinal surgery and heart problems. He also became hyperallergic.
Brewster retired in 2001 under honorable conditions after 23 years of service. He has a one-man home remodeling business that allows him to take time off when he's feeling badly and runs out of energy. He sleeps a lot.
"A lot of the guys hid the illness and still are," said Brewster, who had been a full-time civilian employee of the Guard, in addition to his military service. "Had I not ended up in the hospital, I probably would have tried to hide mine."
The anthrax vaccine, he said, "cost me my career."
1970: FDA approves vaccine for skin exposure
1991: Military gives vaccine to some troops in the first Gulf War
1997: Pentagon orders vaccine mandatory for all military personnel.
1998: Congress passes law requiring informed consent if troops are given drugs unapproved for their intended use.
1998-99: FDA finds quality-control problems at vaccine plant
2000: Sgt. Sandra Larson takes final anthrax shot at Fort Riley, Kan. Larson dies three months later.
2000: Institute of Medicine concludes vaccine is safe.
2000: Federal judge stops mandatory shots.
2005: Voluntary vaccine program begins