Critical GAO Report Belies Safety of Anthrax Vaccine – Insight

Critical GAO Report Belies Safety of Anthrax Vaccine – Insight

Mon, 18 Nov 2002

A highly critical 50-page report by the General Accounting Office (GAO) has put into question the safety of the Anthrax vaccine and the credibility of government officials who have withheld information about the vaccine’s serious health risks.

Insight Magazine reports GAO’s criticism is based on the findings of its randomly selected survey with 843 reservists from the Air Force and National Guard. “Alarmed service personnel are avoiding the shots by leaving the military at an alarming rate, and those who submit to the shots are becoming ill at a far greater rate than the Pentagon claimed. According to the GAO, between September 1998 and September 2000 about 16 percent of the pilots and aircrew members of the Guard and reserve had transferred to another unit…” “Of those who changed status or quit, 69 percent said it was because they didn’t want to take the anthrax shots.”

The GAO’s findings contradict the claims of the manufacturer (BioPort) and the Pentagon: “The overall rate reported for adverse reactions was nearly three times that published in the vaccine manufacturer’s product insert, which claimed only 30 percent would experience some adverse reaction.”

In fact, 85 percent of those who were vaccinated reported experiencing some type of reaction. “Of those experiencing side effects, 24 percent had adverse effects considered serious enough for the shots to be discontinued.”

http://www.insightmag.com/news/320556.html

INSIGHT MAGAZINE

GAO: Shots Led to Military Attrition

Posted Nov. 14, 2002

By Timothy W. Maier

When a scientist sent a letter to the president warning that the United States faced great danger from weapons of mass destruction it was his intent to encourage the administration to take precautionary measures. The letter writer was Albert Einstein. His warning to President Franklin Roosevelt on Oct. 11, 1939, came in the midst of an emerging threat from Nazi Germany. It paved the way for the Manhattan Project, a nuclear program to counter Germany’s plan to build an atomic bomb.

Fourteen months ago another letter writer prompted the Bush administration to take precautionary measures against weapons of mass destruction. This time the writer added a lethal dose of anthrax that resulted in five deaths across the country and mass panic in the nation’s capital. If the intent was to push or redirect policy concerning anthrax vaccination, the mission was accomplished. The attack put the Pentagon’s anthrax-vaccination program back on track. The six-shot regime had been on the ropes after a series of congres- sional hearings and critical reports by Army Times and Insight that questioned whether inoculating 2.4 million troops would do more harm than good.

As Insight noted [see “A Dose of Reality,” Sept. 20, 1999, and “Why BioPort Got a Shot in the Arm,” Sept. 20, 1999], hundreds of reservists, including many trained pilots, had resigned rather than face a series of vaccinations that in some cases had resulted in service personnel contracting aseptic meningitis, Guillain-Barré syndrome and lupus.

The Pentagon and BioPort Corp., the sole provider of the anthrax vaccine, downplayed the risks and insisted all was safe. Insight since has learned that in August 2001 senior Pentagon officials explored alternative methods of countering possible anthrax attacks, including developing better antibiotics to fight the virus. Had this occurred it would have finished BioPort, which had poured its resources into building a state-of-the-art facility in Lansing, Mich., to mass-produce anthrax vaccines for the military and eventual ly the public.

The program had been halted when the Food and Drug Administration (FDA) failed to approve a manufacturing license for BioPort. Even when the FDA finally gave the green light in January 2001, the Pentagon did not immediately roll out the program but continued to consider alternatives. The anthrax scare that began in October 2001 seemed to settle the matter but didn’t. Not until May 2002 were vaccinations resumed even for a limited number of “at-risk” troops — nearly eight months after the anthrax attacks. And the identity of the troops receiving the vaccine remains a military secret. Now the Pentagon has announced that substantial quantities of vaccine will be manufactured and kept in reserve for civilian use in homeland security.

Meanwhile, the FBI has been claiming that the anthrax attacks probably were committed by a domestic terrorist with access to a military lab at Fort Detrick, Md. The FBI still refers to Steven Hatfill as a “person of interest” in the attacks, but he has not been charged. Hatfill is in fact a bio-defense scientist who worked at Fort Detrick, but he has been an outspoken critic of the nation’s failure to develop defenses for biological and chemical attacks.

Hatfill warned Insight in 1998 how easily a terrorist could shut down Washington with a single dose of anthrax. When this magazine recently asked for a follow-up interview, Hatfill attorney Victor M. Glasberg replied, “It’s not going to happen.” Hatfill did hold a series of controlled press conferences, proclaiming his innocence. “I went from being someone with pride in my work, pride in my profession, to being made into the biggest criminal of the 21st century for something I never touched. What I’ve been trying to contribute, my work, is finished. My life is destroyed.”

While the FBI explores other leads, and victims of the attack continue to recover, the incident is far from forgotten. For a while the anthrax-letter attacks seemed to quiet critics of the vaccination program. The armed forces wanted to go to fight terrorism, reservists say, and under the circumstances few were willing to be viewed as “too wimpy” to undergo the six-shot regime.

Congress meanwhile seems to have stopped questioning the program’s value. Since the anthrax attacks, Rep. Dan Burton (R-Ind.), chairman of the House Committee on Government Reform, has remained silent rather than continuing his inquiry into why reservists ordered to take the shots were quitting at an alarming rate. Another frequent critic, Rep. Walter Jones, a North Carolina Republican on the House Armed Services Committee, also has kept quiet on the issue. In fact, a Jones congressional staffer tells Insight the congressman has nothing to say about anthrax.

A federal judge dismissed a lawsuit in June 2002 filed by a reservist who charged the vaccine is an experimental drug and therefore cannot be mandated, but critics of the program say an appeal could put the case back in court by April 2003 [see “First Response to Terror,” Jan. 26, 1998]. Other service personnel resisting the mandatory anthrax vaccinations are preparing a class-action lawsuit, to be filed in the next few weeks, seeking injunctive relief to stop the program, Insight has learned. Providing ammunition for these lawsuits are decisions by the United Kingdom to make anthrax vaccinations voluntary and by Canada to stop the program altogether after its attempts to court-martial those who refused the shots failed.

Now a 50-page General Accounting Office (GAO) report again has put into question the safety of the vaccine. The GAO criticized the program after conducting a survey with 843 randomly selected reservists from the Air Force and National Guard.

The GAO review, which Rep. Jones ordered, reaffirms what Insight previously had reported. Alarmed service personnel are avoiding the shots by leaving the military at an alarming rate, and those who submit to the shots are becoming ill at a far greater rate than the Pentagon claimed. According to the GAO, between September 1998 and September 2000 about 16 percent of the pilots and aircrew members of the Guard and reserve had transferred to another unit (primarily to nonflying positions) to avoid or delay receiving the anthrax shots, moved to inactive status or left the military. Another 18 percent said they intended to leave in the near future. Of those who changed status or quit, 69 percent said it was because they didn’t want to take the anthrax shots.

Those who quit or were reassigned to nonflying positions were experienced pilots with more than 3,000 flight hours on average. In addition, the GAO noted that two-thirds of those surveyed did not support the vaccination program. While the survey was conducted prior to the events of 9/11, which may impact how reservists would respond now, the survey confirmed that the Pentagon had failed to convince reservists that the shots were safe or needed, ultimately resulting in the depletion of trained pilots. Moreover, the GAO says in no uncertain terms that the Pentagon has put one over on Congress by failing to produce data to support claims that the numbers of those leaving are comparable with normal attrition rates.

Among those who took one or more shots, the GAO found that 85 percent reported experiencing some type of reaction. The overall rate reported for adverse reactions was nearly three times that published in the vaccine manufacturer’s product insert, which claimed only 30 percent would experience some adverse reaction. Of those experiencing side effects, 24 percent had adverse effects considered serious enough for the shots to be discontinued. These systemic reactions included malaise and lassitude, chills and fever. The rate for these reactions was more than 100 times higher than claimed in the insert provided to those taking the shots. The rates may have been even higher, the GAO noted, because many adverse reactions were not reported to military command for fear of loss of flight status, negative effect on military or civilian careers and potential for being ridiculed.

The GAO recommended that the secretary of defense direct the establishment of an active surveillance program to identify and monitor adverse events associated with each anthrax immunization. The program, the GAO suggests, should ensure that appropriate and complete treatment and follow-up are provided to those who have experienced adverse effects and to those who may experience them in the future.

The Pentagon has refused to do so, citing a National Academy of Sciences (NAS) claim that there are “no data that indicate the need for the continuation of special monitoring programs.” This “is misleading,” the GAO charges, because the NAS actually suggested that the Pentagon regularly should study data for new trends and monitor reactions to vaccinations. Not to do so would lead to continued depletion of reserve forces, the GAO warned.

“Unfortunately, the actual losses and expected losses as a result of this program represented some of the most experienced and highly trained individuals in these services and are people not easily replaced,” the GAO noted. “It takes time and a great deal of money and other resources to develop trained, experienced pilots and other aircrew members to support the important missions of these reserve components, particularly in light of the current battle against terrorism.”

Timothy W. Maier is a writer for Insight. mailto: tmaier@insightmag.com

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