Anthrax vaccine a deadly defense?

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http://www.thetimesonline.com/articles/2003/06/22/news/top_news/8096364ebe0cdc9d\

86256d4c007d7c23.txt

 

 

Anthrax vaccine a deadly defense?

BY LAURI HARVEY

Times Staff Writer

The Department of Defense's anthrax vaccination program, deemed " unusually

hazardous " by the military itself, is being forced on soldiers who can not

refuse it without risking disciplinary action.

 

U.S. Army Reserve Spc. Rachael Lacy, 22, of Lynwood, died in April after

receiving the vaccination, along with a smallpox inoculation. A coroner ruled

the shots were contributing factors in her death, a ruling which the military

claims there is no evidence to support.

 

Lacy made no attempt to refuse the vaccines, but others who have faced the

consequences. Because the program is administered by military commanders -- not

doctors -- refusing the shots is tantamount to refusing an order.

 

" It allows the commanders to force all who are under them to take it or risk the

consequences, " said Meryl Nass, a medical doctor from Maine and an expert on the

program. " No one wants anyone in their command to refuse it because it makes

them look bad. "

 

The military sees it differently.

 

" The reason it is mandated is because the military works as a team, " said Col.

John Grabenstein, deputy director for military vaccines for the Army surgeon

general. " If you and I are on the same team and I refuse it, your chances of

survival are lessened by my refusal. "

 

Maj. Thomas " Buzz " Rempfer of the Connecticut Air National Guard saw it

differently still. As a member of the command staff, he felt ordering the

vaccines would be improper.

 

" I refused it because I felt I was duty-bound to refuse it, " Rempfer said. " Not

only was it most likely illegal ... the moral or ethical foundation was lacking

because information we received from the Department of Defense was fundamentally

wrong. "

 

Rempfer refused to take the vaccine in 1998 and was subsequently grounded.

 

Rempfer -- speaking on his personal opinions and not on behalf of the military

-- said he believes the military simply is not willing to admit they made a

mistake.

 

" They're doing their darndest to ignore it, " Rempfer said. " The project itself

was so massive in its scope, and so many people invested their integrity in the

program, to have it fail would be unacceptable. "

 

The Department of Defense said that since the program began in 1998, some

half-million members of the military have received the vaccine. All 2.4 million

military personnel are scheduled to receive the inoculations.

 

A general accounting office report released last fall showed that between

September 1998 and September 2000, 16 percent of pilots and aircrew members in

the Guard and Reserves transferred to another unit, moved to inactive status or

left the military to avoid the vaccine.

 

While the Department of Defense says it " has no formal method of counting

refusals, " it acknowledges that as of 2002, some 441 active duty service members

have refused the vaccines. In addition, some 300 pilots in the Guard and

Reserves reportedly have refused the shots, according to documents provided by

pilots to Congress.

 

Of those soldiers who have refused the shots, 101 have lost courts-martial over

the issue, according to Nass, an expert witness in many of the cases.

 

Nass said the problem is complex, but a simple solution could be put in place

quickly until the bigger questions can be answered.

 

" I don't think we should vaccinate anymore people, " she said.

 

Human guinea pigs

 

The U.S. Department of Defense contracted with then-Michigan Biologic Products

(now BioPort Corp.) of Lansing, Mich., in 1998 to provide the anthrax vaccine to

its service members. BioPort is the sole manufacturer of the anthrax vaccine and

therefore, the sole government contractor for the product.

 

U.S. Secretary of the Army Luis Caldera in 1998, citing, " unusually hazardous

risks, " granted BioPort indemnity under Public Law 85-804, which guarantees the

company immunity from litigation related to the anthrax vaccine.

 

The law states that only liabilities that arise in cases where the federal

contractor is engaged in, " unusually hazardous or nuclear risks " are covered. If

BioPort is sued over the issue, the liability now falls to the federal

government.

 

BioPort sold the day after Caldera granted indemnity. One of the partners in the

purchase was Adm. William Crowe, President Reagan's former head of the joint

chiefs of staff. When Bill Clinton was on the campaign trail in 1992 and accused

of being a draft dodger, Crowe came to his defense.

 

Clinton returned the favor when elected president and named Crowe ambassador to

Great Britain. Crowe left the spot in 1997 and bought BioPort in 1998.

 

Since 1998, when the government agreed to indemnify BioPort, more than a dozen

lawsuits have been filed against the company. Most were thrown out on procedural

grounds.

 

But one lawsuit appears to be making ground. In May 2002, 112 soldiers and their

spouses filed an $8 million lawsuit against BioPort alleging negligence, breach

of warranties, breach of the right to be treated with essential human dignity,

strict product liability, fraud, civil rights violations and punitive damages.

 

" Defendants knew soldiers, like plaintiffs, were involuntarily compelled to

submit to the vaccine without knowledge of these facts and circumstances, " the

suit claims. " Soldiers, such as plaintiffs, thus became human guinea pigs made

to test a product over which defendants had the monopoly. "

 

BioPort representatives did not return calls seeking comment, but their Web site

touts their product and its uses.

 

Despite the " unusually hazardous " designation, the Department of Defense's

Anthrax Vaccine Immunization Program Web site supports the vaccine as " safe, as

safe as other vaccines. "

 

" We have committed ourselves to the highest level of science, and what is

science? The best way to keep from fooling yourself, " Grabenstein said. " Seven

independent panels of civilian panelists and scientists have concluded the

anthrax vaccination is safe. "

 

Those panels were from the National Academy of Sciences, which was established

by Congress to provide scientific and technical advice to the nation. While the

panelists are indeed civilians, Grabenstein acknowledged the government is

paying for their work.

 

There have been issues with the legality of the licensing of the vaccine as

well. Critics argue that the vaccine never has been proven effective for

inhalation anthrax. The data the FDA cites in saying the vaccine is 92.5 percent

effective is from a 1950s-era blind study on mill workers processing animal

hair.

 

The FDA acknowledges the study was conducted using a product " similar to the

anthrax vaccine. "

 

According to the FDA, during the trial period, 26 cases of anthrax were reported

at the mills -- five inhalation and 21 cutaneous, or skin contact cases. Because

no cases of inhalation anthrax occurred in those who received the vaccine, the

study concluded a 92.5 percent efficacy level for the inoculation.

 

A license was granted for the vaccine in 1970, without showing it was safe for

human use.

 

The government published findings on the safety of the vaccine for humans in

1985 -- from a study it began in 1972 -- but without providing a comment period

required in order to issue a final ruling. To date, a final ruling has never

been issued.

 

Without a final ruling, according to federal law, it can not be challenged in

the courts.

 

The 1985 findings concluded the vaccine was safe and effective, but its

effectiveness against inhalation anthrax was not known.

 

Still, Grabenstein supports the vaccine's use.

 

" The FDA itself says the license is a license to prevent anthrax and it does not

differentiate between the route of exposure, " Grabenstein said. " The anthrax

vaccine does protect against anthrax, all forms. "

 

Nass said the military has a series of " pat answers " to questions surrounding

the vaccines.

 

" Because of all the controversy, the Army did its own so-called research, " Nass

said. " Everything they published said the vaccine is perfectly safe. Everyone

else that has looked into the anthrax vaccine has found significant problems.

You can't ask for more research to be done (by the military) because they'll say

it's been done and it's safe. "

 

Nass said more information is needed in certain areas.

 

" We know a lot about reactions, birth defects, a number of autoimmune

disorders, " Nass said. " We don't have incidence data. We need to know how many

people have anything and what they have. We also need to figure out if there is

any way to treat these people. "

 

 

 

Death after vaccines

 

Army Reserve Spc. Lacy was studying to be a nurse when she was called to active

duty in February. The South Suburban College student worked at a Lansing

pizzeria and was a member of the 452 Combat Surgical Hospital unit, out of

Milwaukee, where she served as a combat medic.

 

According to a base spokeswoman, Lacy's unit arrived at Fort McCoy, Wis., on

Feb. 27, " to support the global war on terrorism. "

 

She received the smallpox and anthrax vaccines along with the other soldiers in

her unit within the week, according to the spokeswoman. Lacy began feeling ill

March 17, and she went to a local emergency hospital in Sparta, Wis., about

seven miles from Fort McCoy.

 

The doctors there began giving Lacy antibiotics, thinking she had pneumonia. She

was then referred and admitted to a hospital in LaCrosse, Wis. When Lacy's

condition did not improve, she was sent to the Mayo Clinic in Rochester, Minn.,

on April 2.

 

She died there three days later.

 

The official cause of death noted on the death certificate by Olmsted County

Coroner Eric Pfeifer is diffuse alveolar damage, meaning widespread damage to

the sacks of the lungs. Underlying factors are listed as, " lymphocytic

pericarditis with eosinophils, post vaccination, " an inflammation of the sack

surrounding the heart, in addition to an allergic reaction impacting the white

blood cells.

 

According to Pfeifer, contributing conditions included, " recent smallpox and

anthrax vaccination. "

 

But Grabenstein insists the case is still considered an " unexplained death, "

saying that the conclusion on the death certificate does not mean the case is

closed.

 

" Death certificates always conclude something, " Grabenstein said.

 

The coroner is part of a collaborative team of the CDC, FDA, Department of

Defense and state of Minnesota trying to come to a conclusion as to the cause,

according to Grabenstein.

 

Pfeifer was not available for comment.

 

" As (the coroner) told me, there is no evidence of any vaccine involvement,

zero, " Grabenstein said. " There is a theory, but it is not a conclusion. "

 

Initial reports indicated Lacy may have unknowingly had lupus -- an autoimmune

disorder that inhibits the body's ability to fight infection and disease -- when

she received the inoculations. CDC recommends individuals that have a known

autoimmune disorder should not receive the smallpox and anthrax vaccines.

 

The coroner's report on her death stated that a " lupus-like autoimmune disease "

was a contributing factor in her death. Lupus itself was never diagnosed.

 

Nass said lupus-like diseases sometimes arise after patients receive the anthrax

vaccine.

 

" Many soldiers have developed (similar conditions) after anthrax vaccine, but

this does not mean they developed lupus, " she said.

 

Nass said she recently spoke with the Lacy family and learned they are having a

hard time obtaining a copy of autopsy results on their daughter.

 

" I wasn't surprised, because it's very controversial, " Nass said. " The

Department of Defense stands to lose a lot of money if these deaths are linked

to the vaccine. "

 

Nass said those who are becoming ill are being ignored, and sometimes, forced to

face more medical risks.

 

" There are people getting known adverse reactions to the vaccines that are

listed on the package insert and are still being made to take the subsequent

vaccines, " she said. " It is a disaster. "

 

Right to refusal?

 

Like Rempfer, when retired Lt. Col. Mike Angarole joined the Wisconsin Air

National Guard in 1992, he knew taking orders was part of the job. When he

became a member of the command staff, part of his job would be giving orders as

well.

 

But when the order came down in February 1999 to take the anthrax vaccine -- and

to demand that his squadron do the same -- the pilot refused.

 

" Our chain of command said it would be mandatory at the time for us, " he said.

" I said I have a right as a civilian to refuse it. ... You're not supposed to be

a sacrifice for your country. You're supposed to make the other guy die for his

country. "

 

Angarole, a Madison, Wis., resident and commercial pilot flying out of Chicago's

Midway Airport, said given the concerns he had about the vaccine's safety, he

wasn't willing to put himself, his family and his fellow soldiers at risk.

 

" I couldn't take command of the squadron knowing people had gotten ill, "

Angarole said. " When you start taking into consideration my future outside of

the military, that's where I draw the line. I didn't give up all my rights when

I signed on the dotted line. A soldier is a civilian first and then a soldier. "

 

Six others joined him in his refusal, and their superiors were not pleased.

 

" We weren't seen as traitors, but as malcontents, " he said.

 

He and the others were ordered to meet with a doctor and a lawyer, who explained

their options -- take the shot or risk not being allowed to fly and being cited

for dereliction of duties.

 

He still refused, and the Guard grounded him. Because he was a lieutenant

colonel and member of the command staff, he wasn't disciplined as some others

had been with a court-martial. With just six months left to go before he could

retire from the Guard, Angarole decided to transfer to the Air Force Reserves

and secure his retirement there.

 

Many of the others from his unit who refused the shots did the same.

 

" They still tried to make it difficult and really didn't want us, " he said. " We

were seen as rabble rousers. "

 

Angarole believes the military would rather force a program it knows is flawed

than admit it made a mistake that may have had deadly consequences.

 

" At the time, we were at peace, " he said. " We knew anthrax was out there and had

been out there for a number of years. But some people were trying to make four

stars, to be able to say, 'Hey, look how well we're taking care of our

military,' at all costs. "

 

Angarole went to D.C. in 1999 hoping two bills would come to the floor that

would cease mandatory requirements for the vaccine based on those who already

had suffered health problems and the subsequent need for further scrutiny.

 

The bills never made it out of committee.

 

The pressure may be on the government even more to back its plan, now that some

lawmakers are questioning whether the Bush administration exaggerated the threat

of weapons of mass destruction in Iraq that led to the latest round of shots. To

date, weapons inspectors have not been able to uncover any biological weapons in

Iraq. Bush and his political allies have dismissed the allegations as

politically motivated.

 

" Uncle Sam rarely fesses up, and if he does, it is after years and years have

passed, " he said. " We said we just want it to stop and do it right. If you're

going to offer something to the troops, the tip of the spear, the young

servicemen and women who are willing to lay down their lives for their country,

at least give them the best vaccine you can.

 

" For me, I have troops I have to face 20 years from now. I want to say, 'I took

good care of you. I didn't drink the Kool-Aid. "

 

Lauri Harvey can be reached at lharvey or (219) 933-4169.

 

 

 

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