For Release on Delivery

Expected at 10:00 a.m.

Wednesday,

October 11, 2000

GAO-01-92T

ANTHRAX VACCINE

Preliminary Results of

GAO’s Survey of

Guard/Reserve Pilots and

Aircrew Members

Statement of Kwai-Cheung Chan, Director

Applied Research and Methods

Testimony

Before the Committee on Government Reform, House of

Representatives

United States General Accounting Office

GAO
Page 1 GAO-01-92T

Mr. Chairman and Members of the Subcommittee:

We are pleased to be here today to discuss the preliminary results of the

ongoing work we are doing at your request on the Department of

Defense’s (DOD) Anthrax Vaccine Immunization Program. As you know,

numerous concerns have been raised about the program since DOD began

vaccinating its 2.4 million active duty and reserve members in 1998.1

 Of

particular concern was the program’s potential impact on the Air National

Guard and Air Force Reserve’s retention of trained and experienced

personnel.

In response to your request, we are examining the impact of the

vaccination program on retention, the basic views of Guard and Reserve

pilots and other aircrew members regarding the program, and the extent

of adverse reactions experienced by anthrax vaccine recipients. These

components provide essential support to critical defense operations on a

worldwide basis. They provide strategic and tactical airlift, aerial

refueling, aeromedical evacuation, and augment DOD’s overall fighter

force.

To conduct our work, we developed, pre-tested, and validated a

questionnaire that was sent to 1,253 randomly selected Guard and Reserve

pilots and other aircrew members. These included pilots, flight engineers,

loadmasters, navigators, crew chiefs, and others. Collectively, they

represent about 13,000 servicemembers of the total fiscal year 1999 end

strength of approximately 176,000, which includes about 29,000 officers

and 147,000 enlisted personnel. We shared the draft questionnaire with

DOD program officials and their medical experts and incorporated

appropriate comments and suggestions. We administered the survey on an

anonymous basis between May and September 2000. The overall response

rate was 66 percent. Our methodology is described in detail in appendix I.

The information we are presenting today has been weighted to represent

the population of Guard and Reserve pilots and other aircrew members

who are currently active and assigned to a unit.

While many factors can influence an individual’s decision to leave the

military, surveyed Guard and Reserve pilots and aircrew members cited

the anthrax immunization as a key reason for leaving or otherwise

changing their military status. Since September 1998, an estimated

 1

 We have previously reported on a number of concerns regarding the safety and efficacy of the

anthrax vaccine and other related matters. (See appendix III).

Summary
Page 2 GAO-01-92T

25 percent of the pilots and aircrew members of the Guard and Reserve in

this population transferred to another unit (primarily in a non-flying

position), left the military, or moved to inactive status. While several

reasons influenced their decision, when asked to rank the one most

important factor, the anthrax immunization was the highest, followed by

other employment opportunities, and family reasons. Further, about one in

five (18 percent) left before qualifying for military retirement benefits.

Additionally, 18 percent of those still participating in or assigned to a unit

reported their intentions to leave within the next 6 months. These

individuals also ranked the anthrax immunization as the most important

factor for their decision to leave, followed by unit workload and family

reasons. Each of these groups—those who have left and those who plan to

do so–had accumulated an average of more than 3,000 flight hours, which

symbolizes a seasoned and experienced workforce.

On our survey, most Guard and Reserve pilots and aircrew members

expressed a positive view toward general immunizations. Almost three out

of four believe that immunizations are effective (74 percent), and more

than half believe immunizations to be safe (60 percent). However, their

views on the anthrax immunization program and potential biological

warfare immunizations in the future are very different. For example, two

out of three reported little or no support for the anthrax program

(65 percent). Despite DOD’s high-visibility campaign to educate

servicemembers about the anthrax immunization program, only about one

in four believes that the information provided on DOD’s anthrax Web site

is timely (25 percent), 19 percent believe it to be complete, and 17 percent

believe it to be accurate. Just 1 in 10 (11 percent) believe the information

to be unbiased. Further, three out of four indicated they would not or

probably would not take the shots if the anthrax immunization program

were voluntary (76 percent). Eighty-seven percent, or almost 9 out of 10,

indicated they would or probably would have safety concerns if additional

vaccines for other biological warfare agents were added to the military

immunization program.

Forty-two percent of the respondents reported that they had received one

or more anthrax shots. Of those taking the shots, 86 percent reported

experiencing some type of local or systemic reactions, for example, a knot

in the arm or joint pain. For some reactions, the reported duration was

more than 7 days (for example, limited arm/body motion and joint pain).

Some of these reactions could have implications for work performance.

About one-third (36 percent) reported that they had been provided

information concerning what action to take in the event of side effects or

reactions. But 71 percent reported being unaware of the Food and Drug

Administration’s Adverse Events Reporting System which is a passive
Page 3 GAO-01-92T

surveillance system to alert the Food and Drug Administration and the

Center for Disease Control and Prevention of adverse events that may be

associated with licensed vaccines. Further, about 60 percent of those

experiencing reactions had not discussed them with military health care

personnel or their supervisors—some citing fear of the loss of flight status,

possible adverse effects on their military or civilian careers, and ridicule as

reasons for nondisclosure (49 percent).

In December 1997, the Secretary of Defense announced that all U.S. forces

would be inoculated against the potential use of anthrax on the battlefield.

In August 1998, DOD began immunizing its 2.4 million U.S. military

personnel—including active and reserve component personnel—with a

licensed anthrax vaccine. This program is mandatory. Some members of

the armed forces have expressed concerns regarding the safety and

efficacy of the anthrax vaccine. Those refusing the vaccine have been

disciplined under service-specific policies for disobeying a lawful order.

Anecdotal information suggests that an unknown number of Reservists

and National Guard members have resigned or transferred to units or nonflying positions that do not require anthrax vaccinations at this time. DOD

does not collect uniform records on such changes in status.

Congress and the Department of Defense have become increasingly

concerned about the readiness of U.S. armed forces. Key reasons for this

concern are the increasing pace (tempo) of operations due to

deployments, parts shortages and maintenance backlogs, and past

problems in recruiting and retaining quality people. The reserve

components are experiencing difficulties in filling their ranks with new

recruits at a time when DOD is relying on them more heavily to support

operations around the world. Specifically, the retention of pilots and other

aircrew members has been and continues to be a problem that could

impact readiness. The impact of an exodus of Guard and Reserve pilots

and aircrew members would be significant. Without adequate numbers of

pilots and aircrew, the Guard and Reserve could not support the active

force in its worldwide operations. In addition, it costs the military an

average of almost $6 million to train and develop a fully qualified

experienced aviator, which the Air Force suggests takes about 9 years.

Background
Page 4 GAO-01-92T

Twenty-five percent of the pilots and aircrew members of the Guard and

Reserve we surveyed have transferred to another unit, left the military, or

moved to inactive status. Of these, 25 percent ranked anthrax

immunization as the most important factor influencing their decision to

leave or transfer followed by other employment opportunities at 16

percent and family reasons at 16 percent. The general military

immunization program was cited as the least important reason for a

change in their military duty status. Further, about one in five (18 percent)

left before they had qualified for a military retirement. Forty-three percent

of those who separated or are no longer in military flying status because of

the anthrax program indicated that they would or probably would

consider returning to a unit or to military flying status if the anthrax

vaccination program were not mandatory.

Of those who are still in Guard and Reserve units, 18 percent reported that

they planned to leave the military within the next 6 months. Again, when

asked to rank the most important factor for their decision to leave, the

anthrax immunization was the most frequently reported reason

(61 percent), followed by heavy unit workload and family reasons. Each of

these groups (that is, those who left and those who intend to leave) had in

excess of 3,000 flight hours, which symbolizes a seasoned and experienced

workforce.

Most Guard and Reserve pilots and aircrew members support

immunization programs in general; however, relatively few appear to

support the anthrax program or future immunization programs for other

biological warfare agents. Almost three out of four (74 percent) of the

pilots and aircrew members of the Guard and Reserve believe that

immunizations in general are moderately to very effective, and 60 percent

believe that immunizations are moderately to very safe. On the other hand,

65 percent, or two out of three servicemembers, reported little or no

support for the anthrax immunization.

DOD has employed a high-visibility campaign to educate servicemembers

about the program and has taken steps to address the controversy

surrounding the program. In addition, it expanded its communications

efforts by updating the program’s Internet site, opening a toll-free anthrax

information line and forming a speakers’ bureau of anthrax experts. DOD

also updated briefings for installation leaders and medical personnel to

provide more detailed information on the anthrax threat. We had

previously reported in October 1999 that servicemembers were not

Anthrax Is a Key

Factor Affecting

Individual Decisions

to Change Military

Status

Anthrax Vaccine

Immunization

Program Is Not

Widely Supported
Page 5 GAO-01-92T

satisfied with the information provided to them.2 In our current survey,

relatively few respondents reported being moderately to very satisfied

with the information provided at the DOD Web site. For example, only

19 percent were satisfied with the completeness of the information

17 percent were satisfied with the information’s accuracy, and 25 percent

were satisfied with its timeliness. Just 11 percent were satisfied that the

information was unbiased.

In terms of all information provided by DOD to servicemembers on the

anthrax program through the Web site and other sources, 39 percent

indicated that they were moderately to very satisfied with the information

provided on the military anthrax threat. On the other hand, only 12 percent

were moderately to very satisfied with the information received about the

vaccine’s long-term safety.

Seventy-six percent of survey respondents indicated that they would not

or probably would not take the shots if the anthrax immunization program

were voluntary. Just 11 percent reported they would or probably would

take the shot on a voluntary basis. About 13 percent were uncertain.

Further, 87 percent reported that they would or probably would have

concerns about safety if additional vaccines for other biological warfare

agents were added to military immunization requirements.

Adverse events are adverse outcomes for which a cause and effect

relationship with an exposure (to a vaccine or a medication) has not yet

been determined. DOD has used data from the Vaccine Adverse Event

Reporting System to monitor adverse events (or reactions) to anthrax

vaccinations. It is a “passive” surveillance system, which relies on vaccine

recipients or their health care providers to report any adverse events after

receiving the vaccine. Studies show that significantly fewer adverse events

are reported under a passive system when compared to an active

surveillance system in which vaccine recipients are actively monitored to

identify and track any adverse reactions to a vaccine.

Forty-two percent of the respondents reported that they had received one

or more anthrax shots. Of these, 86 percent reported experiencing side

effects or adverse reactions. About 60 percent indicated that they had not

discussed any side effect to the anthrax vaccine with military health care

personnel or their supervisors—some (49 percent) citing as their reasons

 2Medical Readiness: DOD Faces Challenges in Implementing Its Anthrax Vaccine Immunization

Program (GAO/NSIAD-00-36, October 1999).

Most Adverse Events

to Anthrax

Immunizations Are

Not Reported
Page 6 GAO-01-92T

fear of losing their flight status, adverse effects on their military or civilian

careers, and ridicule. Seventy-one percent reported that they were

unaware of the Food and Drug Administration’s Vaccine Adverse Events

Reporting System. Slightly less than 6 percent of those who had a reaction

reported to this system.

Our survey showed that for some local and systemic reactions (for

example, a knot or lump in the vaccinated arm and joint pain), the

reported duration was more than 7 days. (See table 1 in app. II for a list of

reported reactions). The prevalence and duration of the reported

symptoms varied widely. A number of reported symptoms are expected

reactions to the anthrax vaccine; however, their frequency and duration

was more than DOD reported (0.007 percent). For example, two out of

three reported burning in the vaccinated arm (79 percent) and a knot or a

lump in the vaccinated arm (82 percent). Also, 10 percent reported

swelling in the arm lasting for more than 7 days, and 6 percent reported

arm pain and limited motion for more than 7 days. Six percent reported

extreme fatigue, and 7 percent reported joint pain lasting for more than

7 days.

These reported reactions are significant because they could potentially

impact individual ability to carry out military duties. However, 60 percent

of those who experiencing reactions had not discussed them with military

health care personnel or their supervisors. Forty-nine percent did not

report because the reactions were not severe enough; however, another

49 percent did not report because of the fear of losing flight status,

possible adverse effects on their military and civilian careers, and a fear of

ridicule. Since many individuals are not reporting their reactions to

military medical personnel or to the Vaccine Adverse Events Reporting

System, the actual duration, the extent or impact on units and individuals,

and the ultimate resolution of these reactions are unknown.

Because we had limited time to analyze all of the data we obtained, we will

provide additional detailed analyses of the data to the Committee in a later

report. Other issues such as impact of anthrax vaccine program on morale

and quality of life will also be addressed in that report.

Mr. Chairman, this concludes my prepared statement. I would be happy to

answer any questions you have at this time.

For future questions regarding this testimony, please contact Kwai-cheung

Chan at (202) 512-3652. Other individuals making key contributions to this

testimony includes Sushil K. Sharma, Ph.D., DrPH, Foy D. Wicker and

Stanley J. Kostyla.

Contacts and

Acknowledgments
Page 7 GAO-01-92T

The best way to reliably assess the pulse and views of military members is

by surveying a representative sample of personnel. This year, we

developed and administered such a survey that was designed to obtain the

views of selected Air National Guard and Air Force Reserve personnel

regarding issues associated with the DOD’s Anthrax Vaccine Immunization

Program (AVIP). The survey was mailed in May 2000 to a random sample

of 1,258 personnel. As of September 7, 2000, 829 individuals had completed

and returned the survey. Our work was conducted in accordance with

generally accepted government auditing standards.

The survey was developed with the assistance of discussion groups made

up of pilots and other aircrew members of the Air National Guard and Air

Force Reserve. It was pretested at Andrews Air Force Base, Maryland, and

further pretested and refined at Guard and Reserve units located in

Hartford, Connecticut; Newburg, New York; Madison, Wisconsin; Battle

Creek Michigan; Memphis, Tennessee; Travis Air Force Base, California;

March Air Force Reserve Base, California; Fort Wayne, Indiana; and,

Dover, Delaware

The sample consisted of 1,253 Air National Guard and Air Force Reserve

aircrew personnel who were in the service at any time between September

1998 and February 2000. Our sample was drawn from pilot and aircrew

member populations provided by the Air National Guard and Air Force

Reserve in early 2000. In addition the Anthrax Vaccine Immunization

Program Office provided information as to vaccination status. For the

sample design, personnel in our universe were categorized by two factors:

military status (left versus on board) and vaccine status (shot versus no

shot). The sample was adjusted for groups with differing expected rates of

survey completion and adjusted to provide a level of precision of

+ 7 percentage points.

As of September 7, 2000, we had received 828 responses from eligible

respondents, an overall response rate of 66 percent. We used a contractor

to create a database based on reported responses. We validated the data

provided to us by the contractor to ensure accuracy.

Appendix I

Scope and Methodology

Questionnaire

Development

Sample Construction

Survey Administration
Appendix I

Scope and Methodology

Page 8 GAO-01-92T

The survey responses were weighted to reflect the Air National Guard and

Air Force Reserve population for the survey. This weighting procedure

adjusts for the different proportions of individuals sampled from each cell

and the actual response rate for that cell in the sample design. The survey

results assume that nonrespondents would have answered like

respondents. This assumption involves some unknown risk of

nonresponse bias. Weighting can be used to statistically adjust for

differing sampling rates and response rates; however, weighting cannot

adjust for possible differences between those who do and those who do

not respond to a survey.

Weighting Responses

and Potential

Nonresponse Bias
Page 9 GAO-01-92T

Type of reaction < 1 Day 1-3 Days 4-7 Days > 7 Days Total

Local Percent Percent Percent Percent Percent

Redness 2.5 inches or less 21 20 7 5 53

Redness >2.5 inches 5 12 10 6 33

Swelling in arm 16 18 11 10 55

Burning in arm 60 14 3 2 79

Arm Pain limited motion 20 22 11 6 59

Itching in arm 18 10 7 5 40

Knot/lump in arm 17 14 21 30 82

Systemic

Chills 5 4 3 1 13

Fever 7 6 2 1 16

Extreme fatigue 6 7 3 6 22

Dizziness 1 2 1 1 5

Headaches 6 6 2 1 15

Blurred vision 1 1 0 1 3

Numbness in extremities 3 1 1 2 7

Joint pain 6 5 5 7 23

Memory loss 1 1 1 2 5

Blackouts 0 0 0 0 0

Ringing in ears 2 1 1 2 6

Insomnia 1 1 2 1 5

Nausea 3 2 2 0 7

Other 1 1 2 3 7

Source: GAO Survey, 2000.

Appendix II

Prevalence of Local and Systemic Adverse

Reactions by Duration
Page 10 GAO-01-92T

Gulf War Illnesses:Questions About the Presence of Squalene Antibodies

in Veterans Can Be Resolved (GAO/NSIAD-99-5, Mar. 29, 1999).

Medical Readiness: Safety and Efficacy of the Anthrax

(GAO/T-NSIAD-99-148, Apr. 29, 1999).

Contract Management: Observations on DOD’s Financial Relationship with

the Anthrax Vaccine Manufacturer (GAO/T-NSIAD-99-214, June 30, 1999).

Medical Readiness: Issues Concerning the Anthrax Vaccine

(GAO/T-NSIAD-99-226, July 21, 1999).

Anthrax Vaccine: Safety and Efficacy Issues (GAO/T-NSIAD-00-48,

Oct. 12, 1999).

Medical Readiness: DOD Faces Challenges in Implementing Its Anthrax

Vaccine Immunization Program (GAO/-NSIAD-00-36, Oct. 1999).

Medical Readiness: DOD continues to Face Challenges in Implementing Its

Anthrax Vaccine Immunization Program (GAO/T-NSIAD-00-157,

Apr. 2000).

(713048)

Related GAO Products
Orders by Internet

For information on how to access GAO reports on the Internet, send

an e-mail message with “info” in the body to:

Info@www.gao.gov

or visit GAO’s World Wide Web home page at:

http://www.gao.gov

Contact one:

Web site: http://www.gao.gov/fraudnet/fraudnet.htm

E-mail: fraudnet@gao.gov

1-800-424-5454 (automated answering system)

Ordering Information

To Report Fraud,

Waste, and Abuse in

Federal Programs