Litigation at U.S. Court of Appeals - ANTHRAX-SHOT PLAINTIFFS TELL COURT U.S. DOCUMENTS SUPPORT THEIR CASE
Inside the Pentagon
Elaine M. Grossman
Six military and civilian officials challenging the legality of a Pentagon program to administer anthrax inoculations to hundreds of thousands of personnel argue in a new court brief that the government's own documents demonstrate the vaccine, prior to litigation, had "never been considered formally licensed" to protect against airborne spores.
The Defense Department says the vaccines are necessary for selected forces at risk of infection if a terrorist or enemy nation releases anthrax into the air in the United States or abroad.
After a U.S. District Court judge temporarily shut down the mandatory program in December 2003, the Food and Drug Administration hastily moved to license the vaccine for use against any kind of exposure, including inhalational anthrax (Inside the Pentagon, Jan. 8, 2004, p1).
In response, Judge Emmet Sullivan initially lifted the injunction. But he later determined the FDA had not followed its own rules in approving a broader use of the drug. In October 2004, Sullivan permanently banned the mandatory vaccine program, calling it "illegal" to force service members to be inoculated with a drug being used for an experimental purpose (ITP, Oct. 28, 2004, p1).
DOD recently resumed giving vaccines to those personnel considered at high risk of exposure, but at least for now is limited to doing so on a voluntary basis (ITP, Feb. 3, 2005, p3; and May 5, 2005, p5). Earlier this year, the FDA held a public comment period on the proposal to license the vaccine for inhalational anthrax. The agency is still reviewing the results but is widely expected to approve the new use.
Meanwhile, the plaintiffs have filed the new legal document in response to the Bush administration's bid at the U.S. Court of Appeals to reverse Sullivan's 2004 permanent injunction. In its written argument in May, the government emphasized the safety of the anthrax vaccine, saying there is no benefit to be gained by banning mandatory shots but potentially great risk in leaving personnel unvaccinated in Iraq,
Afghanistan and Korea (ITP, May 19, p1). Some defense personnel assigned to homeland security missions in the United States are also taking the six-shot anthrax vaccine series.
In March 2002, the National Academy of Sciences' Institute of Medicine called the anthrax vaccine effective "for the protection of humans against anthrax, including inhalational anthrax, caused by all known or plausible engineered strains."
But the complainants -- six anonymous DOD personnel potentially subject to taking the shots -- dispute the government's assertion that the safety and effectiveness of the anthrax vaccine has never been questioned.
"The plaintiffs specifically challenged, and briefed, the issue of [the anthrax vaccine's] safety and effectiveness" at the lower court, reads the new document, filed July 29. "However, the district court did not reach those issues, having instead determined that sufficient procedural deficiencies existed that mandated judgment in favor of the plaintiffs."
The complainants, who filed the lawsuit in March 2003, say they "are more than prepared to . . . continue their substantive challenges that [the anthrax vaccine] is neither safe nor effective against inhalation anthrax."
But the main thrust of the plaintiffs' argument to dismiss the appeal is that, until recently, the government itself has recognized the anthrax vaccine was not licensed to protect against inhalational anthrax. Until the specter of a potential biological weapon laid the basis for a widespread military inoculation program in 1997, the anthrax vaccine was used primarily by animal handlers and laboratory technicians whose primary risk was skin contact.
"Anthrax manifests itself in different ways based on the route of infection. Cutaneous anthrax is contracted through the skin as a result of handling infected fur or hides or some other material, and is rarely fatal," the plaintiffs write. "Inhalation anthrax has a reported mortality rate of close to 90 percent. . . . It is undisputed that the experts conducting the [1962] human field trial . . . determined that there were too few cases of inhalation anthrax to establish effectiveness of the vaccine against this form of anthrax infection."
Complainants assert a 1980 FDA advisory panel tasked with studying safety and effectiveness similarly concluded the anthrax vaccine could be deemed safe and effective only under the "limited circumstances for which it is employed." At that time, a defense-wide immunization program was not being contemplated.
The plaintiffs argue the Defense Department and the vaccine manufacturer implicitly acknowledged the vaccine was not yet licensed for inhalational anthrax when they applied to the FDA for an "investigational new drug" study on that proposed use in September 1996, as the Defense Department was gearing up for its massive inoculation
program. The application remained actively pending at FDA until the government withdrew it in January 2004, shortly after Sullivan issued the preliminary injunction.
The new brief calls a discussion of the application for a license amendment "inexplicably missing from the government's brief" to the D.C. Circuit Court of Appeals and argues it is "absolutely essential to understanding the ultimate success of plaintiffs' claims."
"In fact," the complainants say later in the filing, "the district court's preliminary injunction was based on the undisputed investigational new drug status of the vaccine, as established by the defendants' own documents."
Those supporting the government perspective on the case respond that the FDA-approved anthrax vaccine label includes no details about the route of exposure and thus does not preclude use against inhalational disease. They argue that in laboratory studies on animal subjects, the drug has been shown to be effective regardless of where in the body the disease manifests itself.
Sullivan's conclusion that the vaccine was licensed solely for skin exposure "frankly was just sort of made up," says one attorney familiar with the case, speaking on condition of anonymity. "The premise that there was some restriction in the labeling was just false because the label was nonspecific."
But plaintiff attorneys also argue the FDA's more recent findings that the vaccine license included inhalational anthrax protection from the start is "irrelevant."
"It was FDA's failure to determine that [the anthrax vaccine] was 'safe, effective and not misbranded,' which had been missing since 1972, that underlies the district court's finding that [the vaccine] is not approved for its applied [or] intended use," the plaintiffs write.
They say that will require the FDA commissioner's "final order" -- a pronouncement that both sides expect sometime soon and one that could quickly make the current case before the appeals court moot.
No date has been set yet for oral arguments in Washington.
Elaine M. Grossman
Six military and civilian officials challenging the legality of a Pentagon program to administer anthrax inoculations to hundreds of thousands of personnel argue in a new court brief that the government's own documents demonstrate the vaccine, prior to litigation, had "never been considered formally licensed" to protect against airborne spores.
The Defense Department says the vaccines are necessary for selected forces at risk of infection if a terrorist or enemy nation releases anthrax into the air in the United States or abroad.
After a U.S. District Court judge temporarily shut down the mandatory program in December 2003, the Food and Drug Administration hastily moved to license the vaccine for use against any kind of exposure, including inhalational anthrax (Inside the Pentagon, Jan. 8, 2004, p1).
In response, Judge Emmet Sullivan initially lifted the injunction. But he later determined the FDA had not followed its own rules in approving a broader use of the drug. In October 2004, Sullivan permanently banned the mandatory vaccine program, calling it "illegal" to force service members to be inoculated with a drug being used for an experimental purpose (ITP, Oct. 28, 2004, p1).
DOD recently resumed giving vaccines to those personnel considered at high risk of exposure, but at least for now is limited to doing so on a voluntary basis (ITP, Feb. 3, 2005, p3; and May 5, 2005, p5). Earlier this year, the FDA held a public comment period on the proposal to license the vaccine for inhalational anthrax. The agency is still reviewing the results but is widely expected to approve the new use.
Meanwhile, the plaintiffs have filed the new legal document in response to the Bush administration's bid at the U.S. Court of Appeals to reverse Sullivan's 2004 permanent injunction. In its written argument in May, the government emphasized the safety of the anthrax vaccine, saying there is no benefit to be gained by banning mandatory shots but potentially great risk in leaving personnel unvaccinated in Iraq,
Afghanistan and Korea (ITP, May 19, p1). Some defense personnel assigned to homeland security missions in the United States are also taking the six-shot anthrax vaccine series.
In March 2002, the National Academy of Sciences' Institute of Medicine called the anthrax vaccine effective "for the protection of humans against anthrax, including inhalational anthrax, caused by all known or plausible engineered strains."
But the complainants -- six anonymous DOD personnel potentially subject to taking the shots -- dispute the government's assertion that the safety and effectiveness of the anthrax vaccine has never been questioned.
"The plaintiffs specifically challenged, and briefed, the issue of [the anthrax vaccine's] safety and effectiveness" at the lower court, reads the new document, filed July 29. "However, the district court did not reach those issues, having instead determined that sufficient procedural deficiencies existed that mandated judgment in favor of the plaintiffs."
The complainants, who filed the lawsuit in March 2003, say they "are more than prepared to . . . continue their substantive challenges that [the anthrax vaccine] is neither safe nor effective against inhalation anthrax."
But the main thrust of the plaintiffs' argument to dismiss the appeal is that, until recently, the government itself has recognized the anthrax vaccine was not licensed to protect against inhalational anthrax. Until the specter of a potential biological weapon laid the basis for a widespread military inoculation program in 1997, the anthrax vaccine was used primarily by animal handlers and laboratory technicians whose primary risk was skin contact.
"Anthrax manifests itself in different ways based on the route of infection. Cutaneous anthrax is contracted through the skin as a result of handling infected fur or hides or some other material, and is rarely fatal," the plaintiffs write. "Inhalation anthrax has a reported mortality rate of close to 90 percent. . . . It is undisputed that the experts conducting the [1962] human field trial . . . determined that there were too few cases of inhalation anthrax to establish effectiveness of the vaccine against this form of anthrax infection."
Complainants assert a 1980 FDA advisory panel tasked with studying safety and effectiveness similarly concluded the anthrax vaccine could be deemed safe and effective only under the "limited circumstances for which it is employed." At that time, a defense-wide immunization program was not being contemplated.
The plaintiffs argue the Defense Department and the vaccine manufacturer implicitly acknowledged the vaccine was not yet licensed for inhalational anthrax when they applied to the FDA for an "investigational new drug" study on that proposed use in September 1996, as the Defense Department was gearing up for its massive inoculation
program. The application remained actively pending at FDA until the government withdrew it in January 2004, shortly after Sullivan issued the preliminary injunction.
The new brief calls a discussion of the application for a license amendment "inexplicably missing from the government's brief" to the D.C. Circuit Court of Appeals and argues it is "absolutely essential to understanding the ultimate success of plaintiffs' claims."
"In fact," the complainants say later in the filing, "the district court's preliminary injunction was based on the undisputed investigational new drug status of the vaccine, as established by the defendants' own documents."
Those supporting the government perspective on the case respond that the FDA-approved anthrax vaccine label includes no details about the route of exposure and thus does not preclude use against inhalational disease. They argue that in laboratory studies on animal subjects, the drug has been shown to be effective regardless of where in the body the disease manifests itself.
Sullivan's conclusion that the vaccine was licensed solely for skin exposure "frankly was just sort of made up," says one attorney familiar with the case, speaking on condition of anonymity. "The premise that there was some restriction in the labeling was just false because the label was nonspecific."
But plaintiff attorneys also argue the FDA's more recent findings that the vaccine license included inhalational anthrax protection from the start is "irrelevant."
"It was FDA's failure to determine that [the anthrax vaccine] was 'safe, effective and not misbranded,' which had been missing since 1972, that underlies the district court's finding that [the vaccine] is not approved for its applied [or] intended use," the plaintiffs write.
They say that will require the FDA commissioner's "final order" -- a pronouncement that both sides expect sometime soon and one that could quickly make the current case before the appeals court moot.
No date has been set yet for oral arguments in Washington.
