June 18, 2003

Anthrax vaccine a deadly defense?

This story ran on nwitimes.com
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."