Inside The Pentagon
December 8, 2005
Appeals Court Pursues Unexpected Inquiry In DOD Anthrax Shots Case
By Elaine M. Grossman
A federal appeals court considering a Bush administration request to restart mandatory anthrax inoculations for selected military personnel this week ordered both sides in the case to submit written arguments on a point of law neither party has emphasized to date.
The government appeal seeks to reverse a 2004 decision by U.S. District Court Judge Emmet Sullivan, who declared the Pentagon anthrax inoculation program "illegal" because the Food and Drug Administration had not properly approved the vaccine for protection against inhaled spores.
On Monday (Dec. 5), the DC Circuit Court directed the government to submit a brief by Dec. 12 on the question of whether the anthrax vaccine is a "drug unapproved for its applied use" under the law governing the armed services, because the vaccine was originally licensed in a manner unrecognized by Title 10 of the U.S. Code.
The drug's license was approved by the National Institutes of Health for individuals such as veterinarians, laboratory workers and others exposed to potentially infected animals.
During Dec. 1 oral arguments before the appeals court, Judge David Tatel asked if the government was relying on a Title 10 provision that requires drug labeling approved by the FDA under the terms of the Federal Food, Drug and Cosmetic Act.
Justice Department attorney Michael Raab replied that the Public Health Service Act extended the coverage of the Federal Food, Drug and Cosmetic Act to NIH-approved biological products like the anthrax vaccine.
What is unusual is that this is not an argument that those who brought the case against the Defense Department have emphasized to date.
Another member of the three-judge appeals panel, A. Raymond Randolph, asked a plaintiffs' attorney to address the issue.
John Michels -- who filed the suit with co-counsel Mark Zaid in 2003 on behalf of five anonymous military personnel and one civilian who refused the shots -- said he did not question the validity of the NIH anthrax vaccine license itself. Rather, he asserted the Defense Department wants to use the anthrax vaccine in a manner "not described in the approved labeling" to protect against inhaled spores, as opposed to less risky skin contact with anthrax.
If so, the anthrax vaccine would be considered an "investigational new drug" and inoculations would require either a service member's consent or a presidential waiver based on national security considerations, Michels said. This is the argument upon which Sullivan's decision -- and his ban on DOD's mandatory shots program -- was based.
Appeals Judge Thomas Griffith also questioned whether there is a legal basis to ban anthrax inoculations across the Defense Department, rather than apply such a remedy solely to the six plaintiffs. But since the status of the vaccine applies to any military personnel, it is a "logical outgrowth" to decide the case Pentagon-wide, Michels argued.
On the question of the anthrax vaccine license validity, the appeals court directed Michels and Zaid to respond to the government brief by Dec. 19. The administration will have an opportunity to reply with another short written brief of its own by Dec. 22.
-- Elaine M. Grossman
Newport News Daily Press
December 6, 2005
Special Report: Anthrax Puzzle
Anthrax Options: The Steps Vary With Location When You Face Vaccination
Troops facing vaccination for anthrax now face education and a choice - not a forced march to the clinic and orders to take the shot or be court-martialed.
By Bob Evans
Third of four parts
Navy Lt. j.g. Patrick Kelly remembers well his first injection with the anthrax vaccine aboard the aircraft carrier Theodore Roosevelt in 1999.
"They told us it was FDA-approved," he says. "They showed the commanding officer getting the first shot, on the closed-circuit TV on the ship. Then they took the whole division, and you all marched down there together. There weren't going to be any missed shots."
None of that - aside from maybe the television programming - is true today.
"The only thing you can say that is mandatory now is that we offer it," Lt. Cmdr. Brad Killenbeck says. He's the force environmental health officer for the Naval Air Force Atlantic Fleet, which includes the Roosevelt and five other carriers based on the East Coast.
During the past five years, more than a million people took the shot, while at least 149 were forced out of the service for refusing. A court-enforced voluntary program has been in place since May 3. It's the consequence of a U.S. District Court judge's ruling that the vaccine was never legally licensed to protect humans from anthrax spores that have been inhaled.
The judge's ruling meant that the drug was, in essence, an experiment for the military. The military can't order or coerce someone to take it. The Pentagon is appealing the case, with a decision expected by February.
The judge's ruling imposes severe limits on what the military can and can't do before injecting someone with the anthrax vaccine. But the Daily Press found differences in what troops can expect if their time for the shot occurs in Hampton Roads.
For instance: They can probably expect a bit more privacy and time to think over the decision if they're in a shore-based command in the Navy or Marine Corps, compared with shipboard Navy and Marine personnel and those in the Air Force and Army.
Army and Air Force personnel who decide not to get the shot can expect counseling about how that decision might hurt their unit's ability to perform its mission, should it be attacked with anthrax.
That counseling should stop short of even subtle pressure to take the shot, John J. Michels says. He's a former Air Force lawyer who represents military personnel and Defense Department employees who brought the lawsuit challenging the vaccine's licensing.
Talking about the medical and military consequences of declining the vaccine is OK, he says, but saying things like "we want you to be part of the team" and keeping a list of who gets the shots and who refuses probably aren't. "The most likely reason to keep track of that is for punitive reasons," Michels says, and that violates the court's order.
In the five months of the voluntary program, he says, there have been only a few incidents where the rules were violated - not bad for an organization as big as the U.S. military. The Pentagon seems to be taking the restrictions seriously, he says.
'It comes down to mistrust'
It isn't clear how troops have responded with this newfound freedom of choice.
Lt. Col. Paul Duch, deputy commander for clinical services at Fort Eustis in Newport News, says 72 percent of the troops at clinics in his command have declined to receive the vaccine. Other local military officers say they'd estimate the number at 50 percent, or they declined to give a figure.
Col. John Grabenstein, director of vaccine programs for the Pentagon, says about half those eligible for the shots worldwide have accepted them. "It means that almost half of the people eligible to be vaccinated are vulnerable to an infection that could kill them," he says.
Critics of the vaccine program say the worldwide 50-50 ratio is a measure of the trust that many people in uniform have about their top leaders and military medicine. They recite a list of experiments where those in uniform have been used as human guinea pigs for testing of radiation, drugs and other exposures since World War II. All were denied, then admitted over time.
"A lot of it comes down to mistrust in the medical system," says one career military officer, who asked not to be identified for fear of retaliation from superiors. "Many of us know someone who got sick after the shot and never got better."
Military medical officers say word of mouth and Internet-fed information about the shot are some of their biggest headaches in trying to educate troops about the vaccine and its side effects. They say that the shot is as safe as any vaccine and that people too often create a cause-and-effect relationship between the vaccine and a subsequent illness when there's none.
"There's a lot of conflicting, confusing stuff out there," says Lt. Col. Megan McCormick, flight commander of public health for the 1st Fighter Wing at Langley Air Force Base in Hampton.
She and other local military medical officers say the voluntary program increases their role as health educators and changes the way that they're practicing medicine.
"We have to change the way we do business," says Cheryl Ann Kraft, head of the regional immunization department of Naval Medical Center Portsmouth. She also oversees immunization for flu, anthrax, smallpox and other diseases at 11 regional clinics on bases throughout southeastern Virginia for Navy, Marine and Joint Forces troops.
Commanders, doctors can alter program
The court order and implementation directives from top doctors in each service branch provide basic requirements of the voluntary program. Then it's up to the doctors and commanders of each unit to customize them to their circumstances.
Instead of inoculating everyone, only those with orders to "designated threat areas" may be offered the vaccine now. The areas primarily involve Korea and Southwest Asia (Iraq, Afghanistan and nearby countries), though other parts of the world can be designated in secret by the military.
Troops should first receive a briefing from their commander or someone in their chain of command on the voluntary program, the vaccine and the danger of anthrax as a weapon. Typically, this takes eight to 10 minutes and involves a slide show or trifold brochure that outlines the program.
Then comes a visit with medical personnel, who again describe the program and answer questions.
For those in the Army, Air Force and ship-based Navy posts, that visit will also include a medical history review and the decision whether to get the shot, local medical officials say.
"We expect most people to accept or decline at that visit," Langley's McCormick says.
"Absolutely," Army Maj. George Goodwin says. Before he deployed for Afghanistan last summer, he was head of immunizations at Fort Eustis.
But for shore-based Navy commands that use the clinics and the Portsmouth hospital, the medical education briefing is followed by at least five days for reading, thinking and questions, says Kraft of the Portsmouth hospital.
"If there's something that's of high concern, you have to brief them, then give them the time to form their questions and then bring them back on a separate day and offer them the vaccine," she says.
Another change that she and others responsible for administering the shot say they've made involves the setting where questions are raised and answered. In the past, this was typically done in groups, which tend to exert peer and command pressure to take the vaccine, stifling questions.
Now there are group meetings and opportunities for private question-and-answer sessions, "so there's no public ridicule," Kraft says.
She and others say they emphasize the availability of responsible Web sites, medical literature and other sources of information. The Portsmouth hospital has a national vaccine center for all service branches, and it can be a "safe haven" for those who have questions but distrust local medical personnel, Kraft says. Its staff is separate from her personnel.
When it comes time to decide whether to get the vaccine, greater provisions for the medical privacy that's taken for granted by civilians is afforded than in years past, Kraft and others say.
A service member should be in a one-on-one private setting if they're in a shore-based Navy clinic, Kraft says. "Every shot we give is administered in a HIPAA setting," she says. That's the Health Insurance Portability Assurance Act, a federal law governing the privacy of medical care and records. At Langley, Fort Eustis and aboard ships, that might not mean you get a room of your own with a doctor, nurse or other medical personnel, however.
"It may not be perfectly private, but we ask people to step back," so they can't hear what's said when the time comes to accept or decline the vaccine, Staff Sgt. Deborah A. Brown says. She gives many of the shots at Langley's hospital.
On ships, it depends on how the skipper and the medical department want to handle it, says Killenbeck of the Naval Air Force Atlantic Fleet.
He says, "There's lots of ways to approach it. There's no one sole universal way."
What is standard is that everyone must sign a document, whether they accept or refuse the vaccination.
Also standard is that once you refuse, military officials aren't allowed to do anything that the court would view as pressuring someone to take the shot.
"If you come in and decline it, then we leave you alone," Langley's McCormick says.
Anyone who experiences pressure should contact the judge advocate general's office on Army, Navy and Marine bases or the area defense counsel on Air Force installations, says Michels, the lawyer representing military personnel in the lawsuit.
Those military lawyers are outside the base chain of command and are expected to report violations to the proper authorities.
The vaccine in theUnited States
1962 -- A study of anthrax vaccine involving goat-hair mill workers is published.
1970 -- The Michigan Department of Public Health receives a license for anthrax vaccine. Most users work at federal biological weapons labs.
1991 -- About 150,000 U.S. troops deployed for the Persian Gulf War get anthrax shots, the first widespread use of the vaccine.
1997 -- Defense Secretary William Cohen orders the beginning of mandatory anthrax vaccination. More than 450 troops refuse to take it in following years.
1998 -- BioPort Corp. is formed. The company buys the anthrax vaccine plant and license rights from Michigan.
2004 -- A U.S. district judge rules the vaccine was not properly licensed for protection against inhaled anthrax and says troops can't be forced to take it until it's properly licensed.
2005 -- The Pentagon begins the voluntary anthrax vaccination program. It appeals the ruling that made the vaccinations voluntary.