Amid pressure to vaccinate civilians at risk for anthrax, evidence has emerged that unauthorized changes in the vaccine manufacturing process before the Gulf War may have radically boosted the potency of the controversial shots.

Veterans groups and armed services personnel have complained that the anthrax vaccine is unsafe, and they say the new evidence lends credence to their view.

Researchers at the Army's biological warfare defense lab found as much as a 100-fold increase in the concentration of the anthrax vaccine's active ingredient in batches produced after a switch to new filters in 1990.

The previously unpublished report was uncovered by investigators of the General Accounting Office, which has been studying the complaints from veterans and military personnel. The GAO released its findings last week.

``Somebody ought to look at this question as we go forward to approve this vaccine,'' said Nancy Kingsbury, managing director for applied research at the GAO.

The Centers for Disease Control and Prevention has recommended that 800 lab technicians who are processing suspected anthrax samples receive the vaccine. It is also considering a recommendation that postal employees who work near high-speed sorting machines receive the vaccine.

Whether higher concentrations of the active ingredient could be harmful is still unknown, investigators say. The active ingredient, known as protective antigens, are particles from a dead anthrax bacteria that are used to stimulate the immune system to produce antibodies. Although the antigens train the body's immune system to attack anthrax bacteria, there can be too many of them.

``Overstimulation of the immune system in certain respects can lead to immunological disorders,'' said Dr. Jack Melling, formerly head of Britain's anthrax vaccine program and a consultant to the GAO.

Vaccine critics say the report bolsters suspicions by veterans that the anthrax vaccine they took in 1990 is somehow related to Gulf War syndrome, the symptoms of which include chronic pain, skin rashes, nausea, memory loss and concentration problems.

Current efforts by the Pentagon to vaccinate 2.4 million military personnel have run into stubborn opposition from soldiers, sailors and airmen who maintain that a disproportionate number of those taking the shots have suffered dangerous side effects.

Army Spc. Sandra Larson of Spokane, Wash., died of aplastic anemia after taking the sixth shot in the series that makes up the vaccine. Last week, her family filed suit against vaccine maker Bioport Corp. of Lansing, Mich., alleging that the vaccine is at fault.

The company maintains that the vaccine is no more dangerous than childhood vaccines used against diphtheria and whooping cough.

Bioport is a private company that acquired rights to anthrax vaccine manufacturing in 1998 from the Michigan Department of Public Health, which had been making it since 1970. Until the Gulf War, it was used primarily by laboratory workers and veterinarians who might be exposed to the rare disease.

Kingsbury's report, delivered to a House national security panel last week, also describes how the Michigan Department of Public Health, under contract with the Pentagon, changed both the reactor vessels in which the vaccine is made and the filters with which it is refined without FDA approval.

In fact, the U.S. Food and Drug Administration knew nothing about the switch from ceramic to nylon filters - which boosted production in 1990 - until GAO investigators informed the agency in December 2000. The changes, including two subsequent switches of nylon filters in 1996 and 1997, were approved after the fact by the FDA only this year.

``This conforms with what we have seen in the past, that the producers played pretty fast and loose with the recipe,'' said Lawrence Halloran, counsel to the House Committee on Government Reform's national security panel, chaired by Rep. Christopher Shays, R-Conn.

Despite concerns raised by the GAO, the FDA contends that nearly a decade of records show the vaccine composition has been consistent. ``The FDA reviewed all potency data results from pre-1990 through 1998 and detected no changes in potency testing results throughout the time period in which filters were changed,'' said FDA spokeswoman Lenore Gelb.

At the same time, the FDA has forbidden Bioport from shipping its vaccine since 1998, citing a variety of quality control problems.

Kim Brennen Root, spokeswoman for Bioport, said Friday that the vaccine is safe. ``The GAO continues to spend time and resources looking for a smoking gun. There is no smoking gun,'' she said.

Lt. Col. John Gravenstein, deputy director of the Pentagon's Anthrax Vaccine Immunization Program, said service personnel should be reassured that the shots are safe. ``The nation's best biological scientists are at the FDA, not the GAO,'' he said.

　　From Healthy.net