Anthrax Vaccine Suit
http://www.truthout.org/docs_2006/121406B.shtml
By Thomas D. Williams, t r u t h o u t | Report
Two years after an earlier lawsuit temporarily halted mandatory anthrax vaccinations for all 2.4 million service members and some military contractors, another group of military service members and Pentagon civilian contractors are going to federal court to block the controversial vaccine's forced use once again.
Six complainants, remaining unidentified to protect them from retaliatory military discipline, filed suit against federal military and health officials Wednesday in US District Court for the District of Columbia. They are asking a judge to once again declare the controversial vaccine an unapproved drug and unlawful for use without informed consent.
Each of the plaintiffs faces either termination from employment or criminal prosecution if they refuse inoculation. The lawsuit is part of a class action on behalf of all military service members and civilians facing inoculation, supposedly to protect them from aerosolized anthrax spores weaponized by terrorists or enemies of the United States.
More than two months ago, the defense department announced a reinstitution of the mandatory inoculation program, applying to those serving in the Korean and Middle East theaters. Prior to that development, for two years, the vaccine was administered voluntarily as a result of a federal court order stopping the vaccine's forced use.
The latest awakening of the mandatory vaccinations developed after the US Food and Drug Administration (FDA) a year ago issued a final rule saying the vaccine is safe, effective, and not misbranded for protection against both skin contact with anthrax and inhalation. The vaccine had been originally approved for skin contact only, not spore attacks through the air.
Defendants in the suit are both FDA and Pentagon officials.
"We don't comment on ongoing litigation," said Cynthia Smith, a defense department spokeswoman, Wednesday. But, she added, "I can assure you that we want to ensure that all of our service members get the proper vaccine to ensure their safety." The FDA has a similar policy of not commenting on court action, but its spokespersons have constantly maintained the vaccine is relatively risk-free and defends adequately against disease.
"We believe in issuing its final order last December the FDA affirmed once and for all the safety and efficacy of our vaccine," said Kim Brennen Root, a spokeswoman for BioPort Corporation, the vaccine's manufacturer. "What is frustrating about that [court action] is that this suit can put in harm's way the service men and women who could be exposed to anthrax in a bioterrorist situation," she said.
But, John J. Michels Jr., co-counsel in the litigation along with DC Attorney Mark S. Zaid, countered: "FDA's certification of the vaccine.is based on slipshod statistical analysis, and an improper use of testing data. [That], as well as the defense department's alteration of the vaccine dosing schedule, renders [it] a drug unapproved for its applied use under current federal law. Under these circumstances, the vaccine may not be administered to service members without their informed consent. [Mandatory use] is patently illegal."
Internal government documents, many of which are described in the lawsuit, reveal a history of regulatory violations and scientific concerns regarding the defense department's anthrax immunization. A 1994 report by the Senate Veterans' Affairs Committee concluded that the vaccine could not be expected to adequately protect troops against airborne anthrax and should be considered experimental. In February 2000, the House of Representative's Committee on Government Reform recommended the termination of the mandatory anthrax vaccination program. In December 2003, and again in October 2004, a federal judge declared the vaccination program illegal until the FDA acted.
Connecticut, especially, has been a hotbed of opposition to the vaccine from the very beginning in late 1997. It was then that former US secretary of defense William Cohen readied his nationwide order, forcing soldiers, sailors, airmen, all other military branches and civilian workers to take the six-shot regimen within 18 months and annual boosters.
US congressman Chris Shays (R-Conn.), State Attorney General Richard Blumenthal and two well known Connecticut US Air Force officers, Thomas Rempfer and Russ Dingle, were leading opponents of the drug. For seven years, in vain, they pressured Congress, two presidents and high-ranking Pentagon officials to halt the program.
The US Government Accountability Office reported that the vaccine's systemic adverse reaction rate was 100 times higher than the 0.2 percent rate reported on the product's label. Adverse vaccine reactions were said by users to include immune disorders, muscle and joint pains, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to use of the vaccine, but they have not been definitively proven as linked.
Nearly 500 active-duty service members have refused the vaccine, and more than 100 have been court-martialed. Additionally, approximately 500-1000 pilots and flight crew members have quit, resigned or transferred from the Air National Guard or Reserves rather than take the vaccine. The vaccine is voluntary in the Australian, British and Canadian militaries, as well as for US Department of State employees, even though they serve in the same geographical region as that of US military service members.
The vaccine was originally produced by an entity of the State of Michigan's health and human services department, MBPI, which has a decidedly mixed record of performance, including failed government inspections. It was later purchased by BioPort of Lansing, Michigan. The purchase fueled controversy because two of the original officers in BioPort were former Michigan state health officials, and a third, William Crowe, was former head of the Pentagon's Joint Chiefs of Staff, and later President Bill Clinton's ambassador to Great Britain.
In the early 1990s, a Japanese doomsday sect used airborne anthrax to attack Tokyo, but it wasn't effective. That was the only known terrorist-type use of the warfare agent until weaponized anthrax, suspected to have been used by domestic laboratory fearmongers, killed five Americans in 2001. Tuesday, the Washington Post reported that 33 members of Congress have written Attorney General Alberto Gonzales demanding that the FBI update lawmakers on the investigation into those anthrax attacks that froze persons nationwide with fear.
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Thomas "Dennie" Williams is a former state and federal court reporter, specializing in investigations, for the Hartford Courant. Since the 1970s, he has written extensively about irregularities in the Connecticut Superior Court and Probate Court systems for disciplining both judges and lawyers for misconduct. His stories about the corrupt activities inside the Hartford Probate Court helped encourage a federal grand jury probe leading to the conviction of the court's investigator for corrupt activities, the first attempted impeachment of a judge or any official in the state's history, and a legislative probe that resulted in major changes of the court's disciplinary system for state lawyers. Another of his investigative inquiries in the 1980s led to the forced resignation of a Superior Court judge who was hiring and appointing friends and relatives for lucrative court duties. His most recent freelance stories exposed failings of the Connecticut Judicial Review Council, investigating misconduct by Superior Court judges and the regular one and a half year delays in deciding State Appellate Court cases. He has received numerous awards for his investigative and in-depth reporting.
By Thomas D. Williams, t r u t h o u t | Report
Two years after an earlier lawsuit temporarily halted mandatory anthrax vaccinations for all 2.4 million service members and some military contractors, another group of military service members and Pentagon civilian contractors are going to federal court to block the controversial vaccine's forced use once again.
Six complainants, remaining unidentified to protect them from retaliatory military discipline, filed suit against federal military and health officials Wednesday in US District Court for the District of Columbia. They are asking a judge to once again declare the controversial vaccine an unapproved drug and unlawful for use without informed consent.
Each of the plaintiffs faces either termination from employment or criminal prosecution if they refuse inoculation. The lawsuit is part of a class action on behalf of all military service members and civilians facing inoculation, supposedly to protect them from aerosolized anthrax spores weaponized by terrorists or enemies of the United States.
More than two months ago, the defense department announced a reinstitution of the mandatory inoculation program, applying to those serving in the Korean and Middle East theaters. Prior to that development, for two years, the vaccine was administered voluntarily as a result of a federal court order stopping the vaccine's forced use.
The latest awakening of the mandatory vaccinations developed after the US Food and Drug Administration (FDA) a year ago issued a final rule saying the vaccine is safe, effective, and not misbranded for protection against both skin contact with anthrax and inhalation. The vaccine had been originally approved for skin contact only, not spore attacks through the air.
Defendants in the suit are both FDA and Pentagon officials.
"We don't comment on ongoing litigation," said Cynthia Smith, a defense department spokeswoman, Wednesday. But, she added, "I can assure you that we want to ensure that all of our service members get the proper vaccine to ensure their safety." The FDA has a similar policy of not commenting on court action, but its spokespersons have constantly maintained the vaccine is relatively risk-free and defends adequately against disease.
"We believe in issuing its final order last December the FDA affirmed once and for all the safety and efficacy of our vaccine," said Kim Brennen Root, a spokeswoman for BioPort Corporation, the vaccine's manufacturer. "What is frustrating about that [court action] is that this suit can put in harm's way the service men and women who could be exposed to anthrax in a bioterrorist situation," she said.
But, John J. Michels Jr., co-counsel in the litigation along with DC Attorney Mark S. Zaid, countered: "FDA's certification of the vaccine.is based on slipshod statistical analysis, and an improper use of testing data. [That], as well as the defense department's alteration of the vaccine dosing schedule, renders [it] a drug unapproved for its applied use under current federal law. Under these circumstances, the vaccine may not be administered to service members without their informed consent. [Mandatory use] is patently illegal."
Internal government documents, many of which are described in the lawsuit, reveal a history of regulatory violations and scientific concerns regarding the defense department's anthrax immunization. A 1994 report by the Senate Veterans' Affairs Committee concluded that the vaccine could not be expected to adequately protect troops against airborne anthrax and should be considered experimental. In February 2000, the House of Representative's Committee on Government Reform recommended the termination of the mandatory anthrax vaccination program. In December 2003, and again in October 2004, a federal judge declared the vaccination program illegal until the FDA acted.
Connecticut, especially, has been a hotbed of opposition to the vaccine from the very beginning in late 1997. It was then that former US secretary of defense William Cohen readied his nationwide order, forcing soldiers, sailors, airmen, all other military branches and civilian workers to take the six-shot regimen within 18 months and annual boosters.
US congressman Chris Shays (R-Conn.), State Attorney General Richard Blumenthal and two well known Connecticut US Air Force officers, Thomas Rempfer and Russ Dingle, were leading opponents of the drug. For seven years, in vain, they pressured Congress, two presidents and high-ranking Pentagon officials to halt the program.
The US Government Accountability Office reported that the vaccine's systemic adverse reaction rate was 100 times higher than the 0.2 percent rate reported on the product's label. Adverse vaccine reactions were said by users to include immune disorders, muscle and joint pains, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to use of the vaccine, but they have not been definitively proven as linked.
Nearly 500 active-duty service members have refused the vaccine, and more than 100 have been court-martialed. Additionally, approximately 500-1000 pilots and flight crew members have quit, resigned or transferred from the Air National Guard or Reserves rather than take the vaccine. The vaccine is voluntary in the Australian, British and Canadian militaries, as well as for US Department of State employees, even though they serve in the same geographical region as that of US military service members.
The vaccine was originally produced by an entity of the State of Michigan's health and human services department, MBPI, which has a decidedly mixed record of performance, including failed government inspections. It was later purchased by BioPort of Lansing, Michigan. The purchase fueled controversy because two of the original officers in BioPort were former Michigan state health officials, and a third, William Crowe, was former head of the Pentagon's Joint Chiefs of Staff, and later President Bill Clinton's ambassador to Great Britain.
In the early 1990s, a Japanese doomsday sect used airborne anthrax to attack Tokyo, but it wasn't effective. That was the only known terrorist-type use of the warfare agent until weaponized anthrax, suspected to have been used by domestic laboratory fearmongers, killed five Americans in 2001. Tuesday, the Washington Post reported that 33 members of Congress have written Attorney General Alberto Gonzales demanding that the FBI update lawmakers on the investigation into those anthrax attacks that froze persons nationwide with fear.
--------------------------------------------------------------------------------
Thomas "Dennie" Williams is a former state and federal court reporter, specializing in investigations, for the Hartford Courant. Since the 1970s, he has written extensively about irregularities in the Connecticut Superior Court and Probate Court systems for disciplining both judges and lawyers for misconduct. His stories about the corrupt activities inside the Hartford Probate Court helped encourage a federal grand jury probe leading to the conviction of the court's investigator for corrupt activities, the first attempted impeachment of a judge or any official in the state's history, and a legislative probe that resulted in major changes of the court's disciplinary system for state lawyers. Another of his investigative inquiries in the 1980s led to the forced resignation of a Superior Court judge who was hiring and appointing friends and relatives for lucrative court duties. His most recent freelance stories exposed failings of the Connecticut Judicial Review Council, investigating misconduct by Superior Court judges and the regular one and a half year delays in deciding State Appellate Court cases. He has received numerous awards for his investigative and in-depth reporting.
