Congressional investigators questioned the long-term safety of an anthrax vaccine administered to America's armed forces despite government assurances Thursday that U.S. troops are being protected, not harmed by the shots.
Skeptical lawmakers suggested the Defense Department discontinue mandating anthrax vaccinations until further studies ensure there won't be health problems later. "Are we using our service men and women as guinea pigs?" asked Rep. John Mica, R-Fla., a member of a House Government Reform Committee panel that held a hearing on the vaccine.
The General Accounting Office, the investigative arm of Congress, found no data on long-term effects of the vaccine.
Kwai Chan, a GAO official, said federal health and drug safety officials have only looked at whether the vaccine appears to protect people from anthrax and whether there were any immediate adverse reactions to inoculation. "The long-term safety of the vaccine has not yet been studied. Therefore one cannot conclude there are no long-term adverse effects," Chan told lawmakers.
Since its introduction three decades ago to protect mill and textile workers, Chan said there have been no reports of fatalities or major illnesses caused by the vaccine. Still, some of the 150,000 Gulf War veterans who received the shot suspect it may be a factor in their mysterious maladies, including fatigue, headaches and nerve disorders.
Defense Secretary William Cohen last year ordered all 2.4 million active duty and reserve troops to be vaccinated against anthrax as protection from biological warfare.
More than 220,000 service members have been immunized so far, the Pentagon said, with 42 reporting adverse effects -- seven serious enough to be hospitalized or take time off. All recovered from complaints including soreness, rashes, headaches and fevers, U.S. officials said.
Between 100 and 200 service members have refused the vaccine and those who reject the shots can be dismissed for refusing a direct order.
Anthrax has never been used in combat, but the Pentagon fears Iraq, North Korea and other countries -- or terrorist groups -- might try. Anthrax is a naturally occurring bacteria found in domesticated animals; it can be produced as dry spores that, when inhaled, cause death within a few days.
The Food and Drug Administration licensed the vaccine in 1970 based on animal studies and on the experience of how well the vaccine worked for those inoculated since the 1950s. It is considered 92.5 percent effective, early studies showed.
Rep. Janice Schakowsky, D-Ill., said she was concerned there were no studies showing how well the vaccine protects against inhaling anthrax spores in a warfare or terrorism scenario. Instead, experience focuses on subcutaneous infection. "What we don't know is just so overwhelming," she said.
Dr. Katherine Zoon, an FDA official, said federal authorities have received 101 complaints of adverse effects from the vaccine sine 1990, only 14 of them serious. "We believe the anthrax vaccine is a safe and effective vaccine for the prevention of anthrax disease," she said.
Brig. Gen. Eddie Cain, head of the Pentagon's biological defense program, called the anthrax vaccine a "key element" of the military's modern force protection program.
Written By Laura Myers