Pentagon Employees Ask for Continued Hold on Mandatory Anthrax Vaccination Program
By David Francis
Global Security Newswire
WASHINGTON — Six U.S. Defense Department employees have asked a U.S. appeals court not to lift an injunction blocking mandatory anthrax vaccinations because the vaccine used in the program has never been formally found safe or approved for use against inhalation anthrax (see GSN, May 23).
In a brief filed July 29 in the United States Court of Appeals for the District of Columbia, lawyers for the employees asked the court to dismiss a Pentagon appeal seeking to have the injunction lifted. The challenge to the vaccination program — over fears of possible side effects — by the six anonymous military and civilian personnel led to a District Court ruling stopping the program in October 2004.
The Pentagon, in a brief filed with the court last month, said Food and Drug Administration documentation on BioPort’s Anthrax Vaccine Adsorbed [AVA] proves the vaccine is safe and effective in combating all forms of anthrax.
The plaintiffs’ lawyers have disputed this claim. They have argued that FDA’s scientific records show the vaccine to be ineffective in combating inhalation anthrax, the form military personnel would be most likely to face in the field. The lawyers have also pointed to an agency advisory panel that found the vaccine to be effective only against anthrax contracted through the skin. The agency accepted the panel’s view in 1985, but changed its position in 2003 by issuing a final order declaring the vaccine effective against inhalation anthrax. However, a federal judge found that the agency did not follow procedures in making that determination, vacated the order, and demanded that FDA officials open the rule for public comments, the brief says.
“Against this undisputed factual background, the government's claim that FDA has consistently considered AVA to include inhalation anthrax is nothing less than ludicrous. At no time did the appropriate FDA officials or experts ever make such a claim. Moreover, until finally forced to do so by the District Court's decision, FDA has carefully avoided making any official pronouncement concerning the AVA’s status,” plaintiffs argued in the brief.
The attorneys have accused the Food and Drug Administration of ignoring this scientific record on the vaccine by issuing the 2003 final rule.
“In short, there is ample undisputed, factual support for the District Court's opinion that AVA was not considered to be licensed for inhalation anthrax by FDA, DOD, or anyone else until it became politically expedient, as opposed to scientifically validated, to do so,” the brief says.
As the vaccine has never been proven safe, the Pentagon is forbidden by military law from requiring troops to take it, the plaintiffs attorney’s have argued. Under U.S. Code Title 10, the military cannot force personnel to take unapproved or investigational new drugs without giving them the option to refuse the drug.
“The District Court granted plaintiffs' motion for summary judgment and enjoined the use of AVA [Anthrax Vaccine Adsorbed] for the simple reason that the vaccine was an investigational new drug or a drug unapproved for its applied/intended use, and that defendant DOD's [Defense Department] involuntary program violated” military law, the brief states. “The undisputed facts show that the only human test of the vaccine did not provide sufficient evidence to support the vaccine's use as a prophylaxis against inhalation anthrax.”
Finally, the plaintiffs’ brief counters the government’s argument that because only six employees challenged the program, the District Court acted improperly by issuing an injunction covering the entire military. The brief says that because the vaccination program was based upon the incorrect safety determination by the Food and Drug Administration and because a mandatory vaccination program affects all military personnel, the District Court acted correctly in stopping the program across all armed services.
The plaintiffs’ brief adds that the full injunction saves the government from facing a rash of lawsuits from personnel who claim injury after taking the vaccine. “Without a military-wide injunction, this Circuit [Court] and DOD would face an unmanageable tsunami of litigation. The government complains that any judicial intervention will unduly disrupt military affairs. But the government slyly overlooks the fact that a flood of litigation would be far more disruptive to the military than simply providing informed consent” for the vaccine, the brief says.
The government has 15 days to respond to the brief, said plaintiffs’ attorney John Michels. If the court agrees to hear the appeal, a date would be set for oral arguments, Michels said.
The vaccine has been available to military personnel since May under a voluntary program, after the Food and Drug Administration approved its emergency use. Those wishing to receive the vaccine must be briefed on the risks and benefits of the treatment by their commanders and acknowledge receiving the brochure explaining these risks. The vaccine is available to troops deployed in Central Command theaters, such as Iraq and Afghanistan, and in South Korea.
As of July 7, half of military and civilian personnel offered anthrax vaccinations under the voluntary program have refused the vaccine, according to Military Vaccine Agency figures (see GSN, July 7).
FDA Commissioner Lester Crawford recently extended the voluntary program until 2006 (see GSN, July 25).
Global Security Newswire
WASHINGTON — Six U.S. Defense Department employees have asked a U.S. appeals court not to lift an injunction blocking mandatory anthrax vaccinations because the vaccine used in the program has never been formally found safe or approved for use against inhalation anthrax (see GSN, May 23).
In a brief filed July 29 in the United States Court of Appeals for the District of Columbia, lawyers for the employees asked the court to dismiss a Pentagon appeal seeking to have the injunction lifted. The challenge to the vaccination program — over fears of possible side effects — by the six anonymous military and civilian personnel led to a District Court ruling stopping the program in October 2004.
The Pentagon, in a brief filed with the court last month, said Food and Drug Administration documentation on BioPort’s Anthrax Vaccine Adsorbed [AVA] proves the vaccine is safe and effective in combating all forms of anthrax.
The plaintiffs’ lawyers have disputed this claim. They have argued that FDA’s scientific records show the vaccine to be ineffective in combating inhalation anthrax, the form military personnel would be most likely to face in the field. The lawyers have also pointed to an agency advisory panel that found the vaccine to be effective only against anthrax contracted through the skin. The agency accepted the panel’s view in 1985, but changed its position in 2003 by issuing a final order declaring the vaccine effective against inhalation anthrax. However, a federal judge found that the agency did not follow procedures in making that determination, vacated the order, and demanded that FDA officials open the rule for public comments, the brief says.
“Against this undisputed factual background, the government's claim that FDA has consistently considered AVA to include inhalation anthrax is nothing less than ludicrous. At no time did the appropriate FDA officials or experts ever make such a claim. Moreover, until finally forced to do so by the District Court's decision, FDA has carefully avoided making any official pronouncement concerning the AVA’s status,” plaintiffs argued in the brief.
The attorneys have accused the Food and Drug Administration of ignoring this scientific record on the vaccine by issuing the 2003 final rule.
“In short, there is ample undisputed, factual support for the District Court's opinion that AVA was not considered to be licensed for inhalation anthrax by FDA, DOD, or anyone else until it became politically expedient, as opposed to scientifically validated, to do so,” the brief says.
As the vaccine has never been proven safe, the Pentagon is forbidden by military law from requiring troops to take it, the plaintiffs attorney’s have argued. Under U.S. Code Title 10, the military cannot force personnel to take unapproved or investigational new drugs without giving them the option to refuse the drug.
“The District Court granted plaintiffs' motion for summary judgment and enjoined the use of AVA [Anthrax Vaccine Adsorbed] for the simple reason that the vaccine was an investigational new drug or a drug unapproved for its applied/intended use, and that defendant DOD's [Defense Department] involuntary program violated” military law, the brief states. “The undisputed facts show that the only human test of the vaccine did not provide sufficient evidence to support the vaccine's use as a prophylaxis against inhalation anthrax.”
Finally, the plaintiffs’ brief counters the government’s argument that because only six employees challenged the program, the District Court acted improperly by issuing an injunction covering the entire military. The brief says that because the vaccination program was based upon the incorrect safety determination by the Food and Drug Administration and because a mandatory vaccination program affects all military personnel, the District Court acted correctly in stopping the program across all armed services.
The plaintiffs’ brief adds that the full injunction saves the government from facing a rash of lawsuits from personnel who claim injury after taking the vaccine. “Without a military-wide injunction, this Circuit [Court] and DOD would face an unmanageable tsunami of litigation. The government complains that any judicial intervention will unduly disrupt military affairs. But the government slyly overlooks the fact that a flood of litigation would be far more disruptive to the military than simply providing informed consent” for the vaccine, the brief says.
The government has 15 days to respond to the brief, said plaintiffs’ attorney John Michels. If the court agrees to hear the appeal, a date would be set for oral arguments, Michels said.
The vaccine has been available to military personnel since May under a voluntary program, after the Food and Drug Administration approved its emergency use. Those wishing to receive the vaccine must be briefed on the risks and benefits of the treatment by their commanders and acknowledge receiving the brochure explaining these risks. The vaccine is available to troops deployed in Central Command theaters, such as Iraq and Afghanistan, and in South Korea.
As of July 7, half of military and civilian personnel offered anthrax vaccinations under the voluntary program have refused the vaccine, according to Military Vaccine Agency figures (see GSN, July 7).
FDA Commissioner Lester Crawford recently extended the voluntary program until 2006 (see GSN, July 25).
