Report to Congressional Requesters

United States General Accounting Office

GAO

June 2001 LYME DISEASE

HHS Programs and

Resources

GAO-01-755
Page i GAO-01-755 Lyme Disease Programs and Resources

Letter 1

Appendix I Background on Lyme Disease 18

Appendix II Centers for Disease Control and Prevention 22

Appendix III National Institutes of Health 24

Appendix IV Recommendations Made to CDC and NIH Lyme

Disease Programs 26

Appendix V Comments From the Department of Health and

Human Services 30

Tables

Table 1: States With the Highest Rates of Lyme Disease 20

Table 2: Expert Recommendations for the CDC Lyme Disease

Program, 1994 26

Table 3: Congressional Appropriation Committees'

Recommendations Related to CDC Lyme Disease

Activities 27

Table 4: Board of Scientific Counselors Recommendations for the

NIAID Lyme Disease Program, 1998 27

Table 5: Advisory Panel Recommendations for NIAID’s Clinical

Studies on Chronic Lyme Disease 28

Table 6: Congressional Appropriation Committees'

Recommendations Related to NIH Lyme Disease Activities 29

Contents
Page ii GAO-01-755 Lyme Disease Programs and Resources

Figures

Figure 1: CDC Allocations for Lyme Disease, Fiscal Years 1991

Through 2000 11

Figure 2: CDC Allocations for Lyme Disease Relative to CDC’s

Overall Appropriations and Infectious Diseases Budget

Authority (Inflation-Adjusted), Fiscal Years 1991 Through

2000 12

Figure 3: NIH Obligations for Lyme Disease, Fiscal Years 1991

Through 2000 14

Figure 4: NIH Obligations for Lyme Disease Relative to NIH Overall

Appropriations (Inflation-Adjusted), Fiscal Years 1991

Through 2000 15

Abbreviations

CDC Centers for Disease Control and Prevention

FDA Food and Drug Administration

HHS Department of Health and Human Services

NCRR National Center for Research Resources

NIAID National Institute of Allergy and Infectious Diseases

NIAMS National Institute of Arthritis and Musculoskeletal and

 Skin Diseases

NIH National Institutes of Health

NINDS National Institute of Neurological Disorders and Stroke
Page 1 GAO-01-755 Lyme Disease Programs and Resources

June 22, 2001

The Honorable Christopher J. Dodd

The Honorable Rick Santorum

United States Senate

The Honorable Virgil H. Goode, Jr.

The Honorable Joseph R. Pitts

The Honorable Christopher H. Smith

House of Representatives

Lyme disease is a systemic, tick-borne disease with varied manifestations,

including abnormalities of the skin, joints, heart, and nervous system.

According to data from the Centers for Disease Control and Prevention

(CDC), Lyme disease is the most common illness transmitted by insects or

other nonhuman organisms in the United States, accounting for 95 percent

of all such reported illnesses. From 1991 through 1999, the annual number

of reported cases of Lyme disease increased by 72 percent. Although Lyme

disease has been reported in 49 states and the District of Columbia, 9

states, mainly in the eastern part of the country, account for 92 percent of

the nationally reported cases.1

 Persons of all ages and both sexes are

equally susceptible, although the highest attack rates are in children under

15 and in adults from age 45 to 65.

For over 10 years, two components of the Department of Health and

Human Services (HHS)—CDC and the National Institutes of Health

(NIH)—have conducted programs to study Lyme disease and educate the

public and professionals about this disease.2 Some practitioners, patients,

patient organizations, and researchers in the Lyme disease community are

concerned about the pace and direction of the research, including studies

of chronic Lyme disease.3

 Given these concerns, you asked that we

examine CDC and NIH research and education on Lyme disease. We

 1

These states are Connecticut, Delaware, Maryland, Massachusetts, New Jersey, New York,

Pennsylvania, Rhode Island, and Wisconsin.

2

The Food and Drug Administration is also part of the federal response to Lyme disease,

but it does not maintain an organized research and education program to combat Lyme

disease in the same way that CDC and NIH do.

3

Chronic Lyme disease is a condition of persisting symptoms in patients who have been

treated for Lyme disease.

United States General Accounting Office

Washington, DC 20548
Page 2 GAO-01-755 Lyme Disease Programs and Resources

address these questions: (1) What activities have the CDC and NIH Lyme

disease programs been engaged in, and to what extent have they initiated

responses to the recommendations of outside experts and congressional

appropriations committees? (2) What funds and other resources have CDC

and NIH devoted to Lyme disease?

We focused our review on those agency components with significant Lyme

disease research and education programs, CDC’s Division of Vector-Borne

Infectious Diseases and NIH’s National Institute of Allergy and Infectious

Diseases (NIAID). We reviewed program plans, grant lists, and financial

documents for activities occurring from fiscal years 1991 through 2000.

CDC and NIH research and education on Lyme disease were examined in

light of the stated objectives of the programs, recommendations to initiate

Lyme disease activities,4

 and program reviews made by independent

experts, but were not judged for their scientific merit. In addition, we

compared CDC allocations for Lyme disease with CDC’s overall

appropriations and budget authority for infectious diseases, adjusted for

inflation.5

 We compared NIH obligations for Lyme disease with

appropriations for NIH and NIAID, adjusted for inflation.6

 We also

interviewed agency officials, patients, officials of patient organizations,

and nonfederal researchers and reviewed minutes from agency meetings

related to Lyme disease. We did not perform an audit allowing us to attest

to the accuracy of the allocations and obligations data provided by the

agencies. We conducted our work from June 2000 through May 2001 in

accordance with generally accepted government auditing standards.

Consistent with their respective missions, CDC and NIH have conducted

an increasingly broad range of research and educational activities related

to Lyme disease. CDC has instituted a system for the surveillance of Lyme

disease, helped to standardize diagnostic testing, conducted and funded

basic research on Lyme disease and on its prevention, and developed

 4

From House and Senate Appropriations Committees’ explanations of the Departments of

Labor, HHS, Education, and Related Agencies Appropriation Bills.

5

Throughout this report, except where otherwise indicated, we have adjusted all dollar

values for general inflation, using the Consumer Price Index for all items with fiscal year

2000 as the base.

6

CDC and NIH were not able to provide us with directly comparable funding data for their

Lyme disease programs. We report the data they were able to provide, allocation data for

CDC and obligation data for NIH.

Results in Brief
Page 3 GAO-01-755 Lyme Disease Programs and Resources

patient and practitioner educational materials. CDC has initiated most

activities recommended by external reviewers and congressional

appropriations committees regarding changes to its programs. For

example, for fiscal year1994 the Senate Appropriations Committee

recommended that CDC continue to develop a substantial pool of

scientific expertise and support for Lyme disease, and in that year CDC

funded a cooperative agreement with the American College of Physicians

to educate physicians who treat Lyme disease. NIH has conducted and

funded basic research on Lyme disease and on its etiology, diagnosis,

treatment, and prevention. In addition, NIH research is addressing two

topics of particular interest to patient advocates, chronic Lyme disease

and the occurrence of other tick-borne infections in Lyme disease patients.

NIH has also responded to most expert recommendations and

congressional recommendations. For example, for fiscal year 1996 the

Senate Appropriations Committee recommended that NIH expand its

research on chronic Lyme disease, which the agency did in the same year

by funding two new studies.

Over the past 10 years, allocations for Lyme disease have increased

slightly at CDC, and obligations for Lyme disease have increased

significantly at NIH. CDC allocations for Lyme disease research and

education have increased 7 percent, from $6.9 million to $7.4 million in

inflation-adjusted dollars, from fiscal years 1991 through 2000. Over the

same period, the CDC infectious diseases budget authority rose from

$48.5 million to $175.6 million, or 262 percent, in inflation-adjusted dollars.

In spite of the slight increase for the entire period, CDC allocations for

Lyme disease declined prior to fiscal year 1998, when the allocation rose

considerably, to $8.3 million in inflation-adjusted dollars. Since then,

allocations have again been declining. In contrast, the NIH increase in

obligations for Lyme disease has been steady and relatively large, at 99

percent. NIH obligations for Lyme disease have increased almost every

year, from $13.1 million in fiscal year 1991 to $26.0 million in fiscal year

2000 in inflation-adjusted dollars. By comparison, appropriations for

NIAID rose from about $1.1 billion to about $1.8 billion, or 55 percent, in

inflation-adjusted dollars over the same period. A portion of the increase

in NIH’s Lyme disease obligations results from a very large increase in

obligations for research on chronic Lyme disease, which has grown, in

inflation-adjusted dollars, from about $124,000 in fiscal year 1991 to

$3.5 million in fiscal year 2000. NIAID funds the majority of Lyme disease

activities at NIH, an average of 69 percent annually over the period

reviewed, but several other institutes have also funded research on the

disease.
Page 4 GAO-01-755 Lyme Disease Programs and Resources

We provided a draft of this report to HHS for review. HHS stated that it

had no comments.

Lyme disease was identified as a separate disease in 1977 because of a

cluster of cases in children in Lyme, Connecticut, who were first thought

to have juvenile rheumatoid arthritis. It was not until 1982, with the

discovery of the causative bacterium, Borrelia burgdorferi, that Lyme

disease could be defined by nonclinical observations. Carriers of Borrelia

burgdorferi include the deer tick in the upper Midwest and Northeast and

the western black-legged tick on the Pacific Coast, two areas where Lyme

disease is considered to be endemic. Lyme disease symptoms generally

appear 7 to 14 days after transmission, but this period may range from 3 to

30 days. Manifestations include musculoskeletal, nervous system, or

cardiovascular irregularities that are not attributable to any other cause.

However, some individuals may have no recognized illness or manifest

only nonspecific symptoms, such as fever, headache, fatigue, and muscle

pain. For more details on the definition of Lyme disease and on its

diagnosis, prevalence, treatment, and prevention, see appendix I.

Federal Lyme disease research programs are administered by two

agencies within HHS. CDC funds laboratory and field research,

surveillance, and education. CDC’s Lyme disease program, an effort of the

National Center for Infectious Diseases, is housed at Fort Collins,

Colorado, in the Division of Vector-Borne Infectious Diseases. NIH funds

intra- and extramural basic and clinical research and promotes

educational activities. NIH carries out its Lyme disease activities at several

NIH institutes and centers, primarily NIAID, the National Institute of

Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National

Institute of Neurological Disorders and Stroke (NINDS), and the National

Center for Research Resources (NCRR). NIAID conducts clinical research

related to Lyme disease at the Clinical Studies Unit on the NIH campus in

Bethesda, Maryland, and laboratory research at the Rocky Mountain

Laboratories in Hamilton, Montana. For more information on the roles of

CDC and NIH, see appendixes II and III, respectively.

The Lyme disease programs at both agencies have been reviewed by

experts for their scientific merit. In 1994, CDC convened an ad hoc panel

of outside experts to review its Lyme disease program. NIH’s Board of

Scientific Counselors, an advisory panel composed of nonfederal experts,

periodically reviews NIH’s intramural research programs, including those

involving Lyme disease. This board reviewed NIH’s Lyme disease program

in 1993 and 1998. Also at NIH, the Advisory Panel on the Clinical Studies of

Background
Page 5 GAO-01-755 Lyme Disease Programs and Resources

Chronic Lyme Disease, a panel composed of nonfederal researchers and

patient advocates, provides guidance on Lyme disease-related clinical

trials. It provided annual reviews beginning in 1996 and continuing through

1999.

CDC and NIH have conducted a broad range of research and educational

activities related to Lyme disease. CDC has instituted a surveillance

system, helped to standardize diagnosis, and funded research on

prevention and education, while initiating most recommendations made by

expert review committees and related activities recommended in

congressional appropriations committees’ reports. NIH has funded

research on the basic nature of Lyme disease and on its diagnosis,

treatment, and prevention, and initiated most related expert and

congressional recommendations.

CDC’s Division of Vector-Borne Infectious Diseases has conducted a broad

range of Lyme disease activities consistent with its program plans. In 1990,

it developed a Lyme disease surveillance case definition,7

 approved by the

Council of State and Territorial Epidemiologists for uniform national

reporting of Lyme disease beginning in 1991. Using surveillance data, CDC

conducted epidemiological and ecological studies of disease and tick

distribution for many areas of the United States. CDC’s research focused

on those areas in which Lyme disease is highly endemic, but some

activities were conducted in areas in which Lyme disease may be

emerging. For example, CDC conducted research in the south central

United States to investigate the emergence of a disease similar to Lyme

disease. In addition, CDC has developed a national map showing risk of

infection based on geographic area.

CDC’s laboratories have conducted basic research on diagnostic test

development. In 1994, CDC, along with a group composed of

representatives of academic research laboratories, state and federal public

health agencies and organizations, and manufacturers of diagnostic tests,

developed a two-step approach to testing for Lyme disease that was more

accurate than individually performed diagnostic tests available at the time.

 7

The CDC case definition is a set of criteria designed to identify individual cases of disease

for surveillance purposes. This definition is not intended to guide patient diagnosis and

treatment.

CDC and NIH

Programs Continue to

Broaden

Understanding of

Lyme Disease

CDC Lyme Disease

Activities
Page 6 GAO-01-755 Lyme Disease Programs and Resources

The two-step approach was developed to detect new cases of Lyme

disease.8

 CDC, in collaboration with NIAID grantees and intramural

scientists, is developing a single-step test that is intended to improve

diagnostic accuracy.9

With regard to the prevention of Lyme disease, CDC

• has developed targeted ways of disseminating tick-killing pesticides,

including feeding devices that apply the pesticides to deer and mice, which

serve as tick hosts;

• has worked with community-based programs to educate high-risk

communities on managing vegetation that can harbor ticks;

• initiated a cooperative research and development agreement with

SmithKline Beecham10 Animal Health and SmithKline Beecham Biologics

to identify and characterize proteins of potential value in the development

of products for immunological protection against Lyme disease and for

new and improved diagnosis;

• monitors the Vaccine Adverse Events Reporting System, along with the

Food and Drug Administration (FDA), to continually evaluate the Lyme

disease vaccine’s safety; and

• has developed written recommendations through its Advisory Committee

on Immunization Practices for the administration of the Lyme disease

vaccine.

To educate the medical and patient communities, CDC

• has funded activities by professional groups and associations to develop

diagnosis and treatment recommendations for both physicians and nurses;

• maintains an informational Web site for patients and health professionals

and provides the public with educational materials;

• has provided training and funds to state and local health departments to

improve surveillance and educational activities, including sponsoring

 8

The Association of State and Territorial Public Health Laboratory Directors, CDC, and the

Michigan Department of Health, Proceedings of the Second National Conference on

Serologic Diagnosis of Lyme Disease (Washington, D.C.: ASTPHLD, 1994), p. 1.

9

F.T. Liang, A.C. Steere, A.R. Marques, B.J.B. Johnson, J.N. Miller, and M.T. Philipp,

“Sensitive and Specific Serodiagnosis of Lyme Disease by Enzyme-Linked Immunosorbent

Assay with a Peptide Based on an Immunodominant Conserved Region of Borrelia

burgdorferi VlsE,” Journal of Clinical Microbiology, Vol. 37, No. 12 (1999): 3990-3996.

10SmithKline Beecham is now part of GlaxoSmithKline.
Page 7 GAO-01-755 Lyme Disease Programs and Resources

conferences and workgroup meetings in 1993, 1994, 1998, and 1999 to

update the Lyme disease community and help guide the future of CDC

Lyme disease programs; and

• has disseminated the results of its Lyme disease research in hundreds of

articles in peer-reviewed journals.

CDC has been responsive to experts and Congress. It has initiated most

Lyme disease-related activities recommended by expert reviewers. In 1994,

three nonfederal reviewers evaluated CDC’s Lyme disease program and

made 16 recommendations. For a list of these recommendations, see

appendix IV. We found evidence that CDC initiated activities consistent

with most of these recommendations. For one recommendation,

concerning the expansion of physician education in the South, we found

no evidence, although the agency did state that it conducted collaborative

research with physicians in that part of the country. CDC initiated work on

all Lyme disease activities recommended in House and Senate

Appropriations Committees’ reports. From fiscal years 1991 through 1998,

Congress made 12 such recommendations. (See app. IV.)

NIH has supported a broad range of research, promoted educational

activities, and improved research capacity related to Lyme disease. Most

Lyme disease activities were funded by NIAID, the lead institute for Lyme

disease. This work has been consistent with NIAID’s general goal for its

Lyme disease program: to develop better means of diagnosing, treating,

and preventing the disease.

Much of the Lyme disease work performed at NIAID’s Rocky Mountain

Laboratories and about 20 percent of NIAIDs Lyme disease grants to

nonfederal researchers have been devoted to research on diagnostic

methods. For example, it has developed a diagnostic test that can

differentiate between those infected with Lyme disease and those who

previously would have tested positive because they had been immunized

with the Lyme disease vaccine. In addition, because ticks may carry more

than one disease, NIH has supported research on the co-infection of Lyme

disease patients with Babesia and Ehrlichia.

11 NIAMS has also supported

research on diagnostics and has developed a DNA-based diagnostic test

for Borrelia burgdorferi, the bacterium responsible for Lyme disease.

 11Babesia are particular kinds of parasites, and Ehrlichia are particular kinds of bacteria.

Both may cause disease and are carried by ticks associated with Lyme disease.

NIH Lyme Disease

Programs
Page 8 GAO-01-755 Lyme Disease Programs and Resources

NIH has also supported research on the treatment of Lyme disease, with

an emphasis on chronic Lyme disease. In 1996, NIAID scientists initiated

research to identify the clinical characteristics of both acute and chronic

Lyme disease. The same year, NIAID entered into a contract to determine

the efficacy of antibiotic treatment of chronic Lyme disease. The treatment

component of this study was terminated after a scheduled review at the

end of fiscal year 2000 because of a finding of “no observed difference” in

self-reported improvement between the treatment and the control

groups.12 In 2000, NINDS initiated funding for a study of the neurological

effects and treatment of chronic Lyme disease.

With respect to prevention, NIH has funded research on

• the basic biology underlying the development of a vaccine for Lyme

disease, later used by SmithKline Beecham to develop a Lyme disease

vaccine;

• animal models for the development and testing of other potential Lyme

disease vaccines;

• tick ecology and control; and

• the relationship between maternal Lyme disease and congenital

abnormalities in newborns.

NIH has produced educational materials and worked with other groups to

sponsor conferences and workshops. For example, NIAID

• produced a 1996 fact sheet for physicians titled, “Tick-Borne Diseases: An

Overview for Physicians,” and a 1998 pamphlet for patients titled, “Lyme

Disease: The Facts, The Challenge”;

• maintains a Web site that provides information on diagnosis and NIAID

activities related to Lyme disease; and

• has disseminated its Lyme disease research through over 100 scientific

articles published by its researchers.

 12M.S. Klempner and others, “Two Controlled Trials of Antibiotic Treatment in Patients

With Persistent Symptoms and a History of Lyme Disease,” The New England Journal of

Medicine (early release on June 12, 2001; final version to be published in the July 12, 2001,

issue): http://www.nejm.org, accessed on June 12, 2001.
Page 9 GAO-01-755 Lyme Disease Programs and Resources

NIH has responded to expert recommendations and to those of Congress.

NIH implemented all recommendations related to the NIAID Lyme disease

program made by the Board of Scientific Counselors, NIH’s external

committee that reviews the intramural program. In 1996 and 1998, the

reviewers evaluated the Lyme disease-directed efforts of Rocky Mountain

Laboratories and the Clinical Studies Unit, and made six

recommendations. For example, the reviewers recommended that the

laboratories hire additional technical staff. NIH followed this

recommendation and pursued activities consistent with all of the others.

(For a list of the recommendations, see app. IV.)

NIH has also initiated activities consistent with most of the

recommendations of the Advisory Panel on the Clinical Studies of Chronic

Lyme Disease. In 1996 and 1999, this panel of outside experts and

advocates provided 15 recommendations regarding the NIAID intramural

and extramural clinical studies on chronic Lyme disease. (See app. IV.)

For example, the panel recommended using standardized

neuropsychological tests in the intramural work. NIH implemented this

and most of the other recommendations. A recommendation that it did not

implement was to establish an unblinded oversight committee to review

the placebo group of the clinical study conducted at the New England

Medical Center. NIH did not believe that such an approach was warranted

because procedures already in place were adequate to safeguard the

welfare of all enrolled in the study.

NIH pursued work on most Lyme disease activities recommended in

House and Senate Appropriations Committees’ reports, including, for

example, one concerning the avoidance of research duplication. (See app.

IV for a list of these recommendations.) From fiscal years 1991 through

1998, Congress made 11 recommendations to NIH regarding Lyme disease.

NIH pursued work on nine of those recommendations. NIH did not fully

address the other two recommendations. One of these was a

recommendation by the Senate Appropriations Committee to establish a

pediatric Lyme disease program at NIAID’s Clinical Studies Unit at NIH’s

Bethesda, Maryland, hospital. According to NIH, because of the invasive

nature of the diagnostic tests required as part of the study planned at that

facility, it was determined that including pediatric patients would not be

appropriate. The second recommendation that NIH did not fully address,

also by the Senate Appropriations Committee, was to consider funding a

center in the Midwest or Southwest to conduct clinical trials of treatments

that would otherwise not be tested. NIH officials told us that they

convened a workshop intended to develop information for physicians on

the diagnosis of, and therapy for, Lyme disease and issued a request-for-
Page 10 GAO-01-755 Lyme Disease Programs and Resources

application for research on the diagnosis and treatment of Lyme disease.

They also told us that, taken together, these efforts helped to build a base

of knowledge and necessary critical mass so that, in the future, research

centers might be a viable option.

Funding related to Lyme disease has increased at both CDC and NIH from

fiscal years 1991 through 2000. The CDC increase in allocations was about

7 percent during that period, from $6.9 million to $7.4 million in inflationadjusted dollars. In spite of the slight increase for the entire period, the

CDC allocations for Lyme disease declined prior to fiscal year 1998, when

the allocation rose considerably, to $8.3 million in inflation-adjusted

dollars. Since then, the allocations have again been declining. In contrast,

the NIH increase in obligations has been steady and relatively large, at 99

percent. NIH obligations for Lyme disease have increased almost every

year, from $13.1 million in fiscal year 1991 to $26.0 million in fiscal year

2000 in inflation-adjusted dollars.

Total CDC allocations for Lyme disease programs increased during the

period reviewed in spite of a downward trend in all years but one.

Allocations, in inflation-adjusted dollars, decreased from $6.9 million in

fiscal year 1991 to $5.8 million in fiscal year 1997, increased in fiscal year

1998 to $8.3 million, and have since declined to $7.4 million. (See fig. 1.)

CDC’s allocations for Lyme disease have grown much more slowly than

CDC’s budget authority for infectious diseases. This budget authority rose

from $48.5 million to $175.6 million in inflation-adjusted dollars over the

same period. The increase in allocations for Lyme disease in 1998

coincided with an increase in the CDC infectious diseases budget

authority. During the period reviewed, Lyme disease allocations increased

by 7 percent, while CDC appropriations and infectious diseases budget

authority increased by 77 percent and 262 percent, respectively. (See fig.

2.)

Funding for Lyme

Disease Has

Increased Slightly at

CDC and Significantly

at NIH

CDC Lyme Disease

Allocations Increased in

1998, but Declined in All

Other Years
Page 11 GAO-01-755 Lyme Disease Programs and Resources

Figure 1: CDC Allocations for Lyme Disease, Fiscal Years 1991 Through 2000

Source: CDC.

4.0

4.5

5.0

5.5

6.0

6.5

7.0

7.5

8.0

8.5

9.0

Inflation-adjusted

Actual

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000

Millions of dollars
Page 12 GAO-01-755 Lyme Disease Programs and Resources

Figure 2: CDC Allocations for Lyme Disease Relative to CDC’s Overall

Appropriations and Infectious Diseases Budget Authority (Inflation-Adjusted),

Fiscal Years 1991 Through 2000

Source: CDC.

The large increase in Lyme disease allocations in fiscal year 1998 was used

to expand grant funding. From fiscal years 1991 through 1997, CDC

reported that grants accounted for 58 percent of Lyme disease funding for

the Division of Vector-Borne Infectious Diseases, while program

operations accounted for 42 percent. However, after the fiscal year 1998

Lyme disease allocations increase, program operations funding remained

relatively flat and grant funding increased from $2.8 million to $5.1 million

in inflation-adjusted dollars. In fiscal years 1999 and 2000, grants have

accounted for 69 percent of Division of Vector-Borne Infectious Diseases

Lyme disease allocations. Over 80 percent of this grant funding has been

used for cooperative agreements with universities and public health

laboratories, with the remainder going to foundations and other kinds of

organizations. The most commonly funded cooperative agreements have

Percentage change since fiscal year 1991

1998 1999 2000

-50

0

50

100

150

200

250

Overall

Infectious diseases

Lyme disease

1991 1992 1993 1994 1995 1996 1997

280
Page 13 GAO-01-755 Lyme Disease Programs and Resources

been related to research on the diagnosis and on the origination and

development of the disease or have involved activities related to

surveillance, diagnosis, prevention, and education.

In 2000, the Division of Vector-Borne Infectious Diseases had 24 full-time

employees working on Lyme disease activities. Fourteen of those

employees devoted 100 percent of their time to Lyme disease activities,

and 10 employees spent from 10 to 90 percent of their time on Lyme

disease.

Total NIH obligations for Lyme disease activities in inflation-adjusted

dollars increased from $13.1 million in fiscal year 1991 to $26.0 million in

fiscal year 2000. (See fig. 3.) NIH Lyme disease obligations rose at a faster

rate than overall NIH appropriations; NIH Lyme disease obligations rose

99 percent, while total appropriations for NIH rose 70 percent over the

same period. (See fig. 4.) The majority of Lyme disease activities are

funded by NIAID, but several other institutes have also funded Lyme

disease research. During the period reviewed, NIAID Lyme disease

obligations also rose at a faster rate than overall appropriations for NIAID.

NIAID obligations for Lyme disease increased from $8.4 million to

$18.2 million, or 116 percent, while overall appropriations for NIAID

increased from about $1.1 billion to $1.8 billion over the decade, or 55

percent, in inflation-adjusted dollars. A portion of the increase in Lyme

disease funding is related to an increase in the funding of chronic Lyme

disease research, which has risen, in inflation-adjusted dollars, from

$124,000 in fiscal year 1991 to $3.5 million in fiscal year 2000.

NIH Lyme Disease

Obligations Increased

Significantly Over the Past

Decade
Page 14 GAO-01-755 Lyme Disease Programs and Resources

Figure 3: NIH Obligations for Lyme Disease, Fiscal Years 1991 Through 2000

Source: NIH.

10

12

14

16

18

20

22

24

26

28 Millions of dollars

Actual

Inflation-adjusted

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000
Page 15 GAO-01-755 Lyme Disease Programs and Resources

Figure 4: NIH Obligations for Lyme Disease Relative to NIH Overall Appropriations

(Inflation-Adjusted), Fiscal Years 1991 Through 2000

Source: NIH.

The majority of NIH Lyme disease obligations were used to fund

extramural grants and contracts, which primarily support scientists within

universities, medical schools, hospitals, and research institutions. From

fiscal years 1991 through 2000, NIH spent 15.3 percent of its Lyme disease

budget on intramural research activities and the rest on extramural

activities. However, in fiscal years 1999 and 2000, NIH reported increases

in intramural funding to 23.4 percent and 26.0 percent of the Lyme disease

budget, respectively. Much of these increases can be attributed to two new

activities: a large intramural study on the diagnosis and treatment of

human uveitis, an eye infection that can be a complication of Lyme

disease, at the National Eye Institute in fiscal year 1999, and an increase in

NIAID intramural research on Lyme disease in fiscal years 1999 and 2000.

NIAID, NIAMS, and NCRR are the three NIH components to have funded

Lyme disease-related activities every year from fiscal years 1991 through

2000. During the past 10 years, NIAID has provided an average of 69

-20

0

20

40

60

80

100

120 Percentage change since fiscal year 1991

Overall

Lyme disease

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000
Page 16 GAO-01-755 Lyme Disease Programs and Resources

percent of the total NIH Lyme disease obligations; however, total NIAID

Lyme disease obligations increased in relation to the Lyme disease

obligations of other institutes and centers. As NIAID Lyme disease

obligations increased, NIAMS and NCRR Lyme disease obligations

remained at around 20 percent and 5 percent of NIH Lyme disease

obligations, respectively, and other institutes began funding small

numbers of grants (fewer than five per year) partially related to Lyme

disease.

Out of its overall obligations for Lyme disease, NIH increased obligations

for grants related to chronic Lyme disease and post-Lyme disease

syndrome13 during the period reviewed. NIAMS awarded grants on chronic

Lyme disease throughout the period reviewed. In fiscal year 1994, NIAID

reported chronic Lyme disease grants totaling $745,692, increasing to

$3.4 million in inflation-adjusted dollars in fiscal year 1999. The majority of

this increase can be attributed to the NIAID clinical trials on chronic Lyme

disease that started in fiscal year 1996. NIAID chronic Lyme disease

obligations decreased to $1.5 million in inflation-adjusted dollars in fiscal

year 2000. However, NINDS initiated a $1.2 million clinical trial on chronic

Lyme disease in fiscal year 2000.

The number of NIH staff working on Lyme disease grew during the period

observed. The majority of NIH staff working on Lyme disease are in

NIAID. NIAID’s Rocky Mountain Laboratories funds three Lyme disease

researchers, and NIAID’s Clinical Studies Unit has one clinical researcher,

plus staff. Both laboratories have added staff during the period observed.

In addition, NIAID has funded a Program Officer for Lyme disease since

1993, to stimulate and oversee grants related to Lyme disease. NINDS,

NIAMS, and the National Eye Institute report that they have one or two

researchers who spend less than 5 percent of their time on Lyme disease.

These researchers are in addition to the extramural researchers working

on Lyme disease with NIH funding.

 13Post-Lyme disease syndrome refers to the presence of symptoms, generally associated

with chronic Lyme disease, in patients who have been treated for Borrelia burgdorferi

infection. Some investigators prefer to use this term because it implies nothing about the

existence or absence of infection, in contrast to “chronic Lyme disease,” which suggests

persisting infection.
Page 17 GAO-01-755 Lyme Disease Programs and Resources

We provided a draft of this report to the Department of Health and Human

Services for review. The department stated that it had no comments. HHS’

response is reprinted in appendix V. HHS also provided technical

comments, which we incorporated where appropriate.

We will send copies of this report to the Secretary of Health and Human

Services, the Director of the Centers for Disease Control and Prevention,

the Acting Director of the National Institutes of Health, and others who are

interested. If you have any questions or would like additional information,

please call me at (202) 512-7119. Marcia Crosse, Donald Keller, William

Hadley, and Roseanne Price made major contributions to this report.

Janet Heinrich

Director, Health Care—Public Health Issues

Agency Comments
Appendix I: Background on Lyme Disease

Page 18 GAO-01-755 Lyme Disease Programs and Resources

The initial stage of Lyme disease is usually marked by one or more of the

following: fatigue, chills and fever, headache, muscle and joint pain,

swollen lymph nodes, and a characteristic skin rash called erythema

migrans. Late manifestations, possibly occurring weeks, months, or years

after infection, include arthritis, nervous system abnormalities, and heart

rhythm irregularities, but for some patients arthritis or nervous system

abnormalities are the first and only signs. The infection is triggered by the

bite of certain kinds of ticks.

Ticks become infected with the bacterium Borrelia burgdorferi while

feeding on an infected animal, particularly the white-footed mouse in the

Northeast. It is estimated that by adulthood from 10 and 50 percent of

ticks in endemic areas carry the disease. Ticks are most likely to transmit

Borrelia burgdorferi while they are in the nymphal stage. Nymphs feed

during the spring and summer months, when people are most active, and

the nymphs’ small size typically allows them to go unnoticed and gives

them ample time to feed and transmit the bacterium, a process that may

take 2 or more days.

According to the Centers for Disease Control and Prevention’s (CDC)

surveillance case definition, a person must meet either of two criteria to

be considered a “confirmed case” of Lyme disease. One criterion is to have

the characteristic rash. The second is to have (1) at least one late

manifestation of Lyme disease from a list of signs and (2) laboratory

confirmation of infection by Borrelia burgdorferi, using recommended

tests.

It is not always easy to diagnose Lyme disease. The only definite

confirmation of Lyme disease is the identification of Borrelia burgdorferi

from a cultured sample. Although specimens can be biopsied, the

procedure is invasive and requires a specific growth medium and

observation period, making it impractical for most clinicians. In part

because of these disadvantages, the CDC-organized Second National

Conference on the Serologic Diagnosis of Lyme Disease, in 1995,

recommended a two-step approach for the laboratory confirmation of

Lyme disease. It consists of a sensitive Enzyme-Linked Immunosorbent

Assay or indirect fluorescent-antibody test followed by a more specific

Western Blot test. These tests measure the body’s immune response, but

they do not directly detect the bacterium. As a result, vaccination,

antibiotic use, co-infection, residual antibodies, and duration since the tick

bite all can affect the accuracy of the tests. Even among those patients

with a history of tick bite, the characteristic rash, and other characteristic

Appendix I: Background on Lyme Disease

Case Definition and

Diagnosis
Appendix I: Background on Lyme Disease

Page 19 GAO-01-755 Lyme Disease Programs and Resources

symptoms, only about 30 percent are positive in the first weeks of

infection using the CDC-recommended two-step approach. For that

reason, CDC recommends that diagnostic tests be used as a confirmation

only when Lyme disease is already suspected.

Reported cases of Lyme disease currently account for more than 95

percent of all reported vector-borne1 illness in the United States. Public

health departments, clinicians, and laboratories have reported over

122,651 cases since 1990. Significant risk of infection with Borrelia

burgdorferi is found in only a select number of states.2

 (See table 1.)

Estimates of prevalence may be inaccurate for two reasons. First, although

it is required, physicians may not report all cases of Lyme disease to CDC.

Second, patients with abnormal Lyme disease symptoms may not be

diagnosed as having Lyme disease. As a result, current diagnosis and

reporting practices may account for only 36 percent of the actual cases.3

However, some research has shown that Lyme disease may be

overdiagnosed in highly endemic areas.4

 1

A vector is an organism, such as an insect, that transmits a pathogen, such as a bacterium.

2

Only Montana reported no cases from 1990 through 1999.

3

G.L. Campbell, C.L. Fritz, D. Fish, J. Nowakowski, R.B. Nadelman, and G.P. Wormser,

“Estimation of the Incidence of Lyme Disease,” American Journal of Epidemiology, Vol.

148, No. 10 (1998): 1018-26.

4

A.C. Steer, E. Taylor, G.L. McHugh, and E. Logigian, “The Overdiagnosis of Lyme Disease,”

Journal of the American Medical Association, Vol. 269, No. 14 (1993): 1812-6.

Estimates of

Prevalence
Appendix I: Background on Lyme Disease

Page 20 GAO-01-755 Lyme Disease Programs and Resources

Table 1: States With the Highest Rates of Lyme Disease

Reported cases

(1990-99) 1999 ratea

Connecticut 20,634 98.0

Rhode Island 3,917 55.1

New York 40,762 24.2

Pennsylvania 17,072 23.2

Delaware 1,177 22.2

New Jersey 14,762 21.1

Maryland 4,177 17.4

Massachusetts 3,287 12.7

Wisconsin 4,488 9.3

Total U.S. cases and average U.S. rate 122,651 6.0

a

Rate per 100,000 residents.

Source: CDC Morbidity and Mortality Weekly Report.

In the guidelines of the Infectious Diseases Society of America, treatment

of Lyme disease ranges from 14 to 21 days of oral antibiotics for early

disease without complications to a 2- to 4-week course of intravenous

antibiotics, repeated once if necessary, for late-stage Lyme disease with

particular manifestations. An untreated or inadequately treated infection

can progress to late-stage complications.

There are several different methods to protect against Lyme disease. CDC

recommends that people active in endemic areas limit their exposure to

tick-infested areas, spray their clothing with insect repellents, tuck in

clothing, and make frequent skin checks. In addition, community

prevention projects have addressed Lyme disease through reducing tick

habitats and developing environmentally friendly methods of pesticide

application. CDC does not recommend antibiotic treatment for a tick bite

to prevent infection if there are no accompanying symptoms.

In December 1998, the Food and Drug Administration (FDA) approved an

application to license a vaccine for Lyme disease. The vaccine requires a

series of three injections to achieve the maximum preventive effect.

Results from a clinical trial conducted by the manufacturer suggest that

the vaccine is 50 percent effective after two doses and 78 percent effective

after three doses. FDA has approved the vaccine for patients between 15

and 70 years of age, and clinical trials for children younger than 15 have

Treatment

Prevention
Appendix I: Background on Lyme Disease

Page 21 GAO-01-755 Lyme Disease Programs and Resources

begun. CDC’s Advisory Committee on Immunization Practices

recommends that only individuals who are at risk in endemic areas be

vaccinated. In addition, it advises physicians not to administer the vaccine

to persons with a history of treatment-resistant Lyme arthritis. The

duration of immunity conferred by the vaccine is not known at this time,

nor are safety and efficacy beyond the manufacturer’s 20-month clinical

trial. The vaccine’s manufacturer has begun postmarketing trials to answer

those questions, and other pharmaceutical companies are developing

second-generation Lyme disease vaccines.
Appendix II: Centers for Disease Control and

Prevention

Page 22 GAO-01-755 Lyme Disease Programs and Resources

The Centers for Disease Control and Prevention’s (CDC) Lyme disease

program, an effort of the National Center for Infectious Diseases, conducts

surveillance, diagnostic research, and education. The program is housed at

Fort Collins, Colorado, in the Division of Vector-Borne Infectious

Diseases’ Bacterial Zoonoses Branch. The branch has four sections

responsible for Lyme disease activities: Epidemiology, Molecular Biology,

Diagnostic Reference Laboratory, and Lyme Disease Vector.

CDC provides Lyme disease funding to state and local health departments,

universities, and nonprofit foundations. CDC has conducted Lyme disease

activities with state public health departments, academic medical centers,

advocacy groups, the Food and Drug Administration (FDA), the

Department of Agriculture, the National Park Service, the National

Aeronautics and Space Administration, and the Council of State and

Territorial Epidemiologists. In addition, CDC has entered into cooperative

research and development agreements with pharmaceutical and diagnostic

test manufacturers.

Specifically, the mission of CDC’s Lyme disease program is to

• develop and maintain national surveillance for Lyme disease;

• perform epidemiological studies, and provide epidemiological assistance

for local and state health departments and to national and local agencies;

• conduct laboratory and field research for improving diagnosis,

understanding the origin and development of the disease, and developing

strategies to prevent and control Lyme disease and other related tickborne diseases;

• provide consultation, education, and training for the public and health

professionals; and

• serve as a national and international Lyme disease reference and research

center.

In addition to the Lyme disease program, CDC maintains two other

activities that relate to Lyme disease, the Vaccine Adverse Events

Reporting System and the Advisory Committee on Immunization Practices.

CDC and the FDA developed and implemented the Vaccine Adverse

Events Reporting System in 1988 to track adverse events associated with

vaccines. Patients, practitioners, and manufacturers are encouraged to

report clinically significant adverse events that may be associated with

vaccinations. An independent contractor, funded by CDC, is responsible

for distributing and collecting forms for reporting adverse events and

maintaining the database. CDC and FDA monitor the data to detect

patterns in the type and severity of adverse events associated with

Appendix II: Centers for Disease Control and

Prevention
Appendix II: Centers for Disease Control and

Prevention

Page 23 GAO-01-755 Lyme Disease Programs and Resources

vaccines. This information enables CDC to direct financial and technical

assistance to public sector vaccine programs as needed.

The Advisory Committee on Immunization Practices, a committee of

external experts, provides advice and guidance about immunization to the

Secretary of Health and Human Services, the Assistant Secretary for

Health, and the Director of CDC. The committee develops written

recommendations, subject to the approval of the Director of CDC, for the

routine administration of new vaccines to pediatric and adult populations,

along with schedules regarding the appropriate periodicity, dosage, and

contraindications applicable to the vaccines. The committee also reviews

and reports regularly on existing immunization practices and recommends

improvements in national immunization efforts.
Appendix III: National Institutes of Health

Page 24 GAO-01-755 Lyme Disease Programs and Resources

The National Institutes of Health’s (NIH) Lyme disease program seeks to

better understand the etiology of the disease and to develop better means

of diagnosing, treating, and preventing it. NIH institutes and centers with

funding related to Lyme disease include the National Institute of Allergy

and Infectious Diseases (NIAID), National Institute of Arthritis and

Musculoskeletal and Skin Diseases, National Institute of Neurological

Disorders and Stroke, National Eye Institute, National Institute of Child

Health and Human Development, Fogarty International Center, National

Institute on Aging, National Institute of Mental Health, and National Center

for Research Resources. NIH designated NIAID as the lead institute for

Lyme disease research in 1992. The NIH Lyme Disease Coordinating

Committee, which has met annually since 1992, was created to facilitate

the coordination of NIH’s varied Lyme disease-related efforts.

NIAID conducts clinical research related to Lyme disease at the Clinical

Studies Unit on the NIH campus in Bethesda, Maryland, and laboratory

research at the Rocky Mountain Laboratories in Hamilton, Montana. The

Board of Scientific Counselors, an advisory panel composed of nonfederal

experts, periodically reviews NIH’s intramural research programs. In

addition, NIH provides funding for Lyme disease through extramural

grants and contracts to universities, medical schools, and research

laboratories. The National Advisory Allergy and Infectious Diseases

Council oversees NIAID’s extramural program. The council performs grant

review, provides policy advice to NIAID, reviews NIAID programs, and

develops program announcements and recommendations for proposals.

The Advisory Panel on the Clinical Studies of Chronic Lyme Disease, a

panel composed of nonfederal researchers and advocates involved with

issues related to Lyme disease, provides guidance throughout each

intramural and extramural clinical trial.

The Clinical Studies Unit began a clinical trial in 1996 to better understand

the natural history of chronic Lyme disease and possible causes for

persisting symptoms. The trial seeks a comprehensive clinical,

microbiological, and immunological assessment of patients who have

suspected chronic Lyme disease despite previous therapy with

intravenous antibiotics. The investigators are enrolling patients and a

variety of control groups in an effort to better understand the origin and

development of chronic symptoms and to study further immunologic

aspects of Lyme disease.

Appendix III: National Institutes of Health

Clinical Studies Unit
Appendix III: National Institutes of Health

Page 25 GAO-01-755 Lyme Disease Programs and Resources

Research at NIAID’s Rocky Mountain Laboratories is focused on the

molecular changes that Borrelia burgdorferi undergoes as it is transmitted

from the tick. One laboratory seeks to understand variations in the

proteins and genes of the organism. A second laboratory seeks to

understand the roles of specific genes and develop the basic genetic tools

necessary to manipulate Borrelia burgdorferi at the genetic level. A third

laboratory seeks to understand the changes and adaptations of the

bacterium as it is transmitted during tick feeding.

NIAID has also funded clinical trials on the treatment of chronic and latestage Lyme disease at the State University of New York at Stony Brook

and the New England Medical Center. The study at Stony Brook examines

how well antibiotics work in reducing fatigue symptoms in patients with

post-Lyme disease syndrome. For this study, the data have been collected

and are being analyzed. The New England Medical Center study examined

the safety and efficacy of two antibiotics for the treatment of patients with

suspected chronic Lyme disease who may or may not test positive for

Lyme disease on diagnostic tests.1

 In November 2000, a Data Safety and

Monitoring Board, an independent monitoring group of doctors and

researchers, unanimously recommended that NIAID terminate the

treatment component of the study. This was suggested because a planned

interim analysis showed no statistically significant difference between the

placebo and the treatment groups, and NIAID agreed. NIAID has extended

the contract for 1.5 years, with additional funding, so that the investigators

can continue to follow the study’s patients to monitor their health status

and to obtain additional information that, in the future, could help to

determine the underlying cause of chronic Lyme disease.

 1

M.S. Klempner and others, “Two Controlled Trials of Antibiotic Treatment in Patients With

Persistent Symptoms and a History of Lyme Disease,” The New England Journal of

Medicine (early release on June 12, 2001; final version to be published in the July 12, 2001,

issue): http://www.nejm.org, accessed on June 12, 2001.

Rocky Mountain

Laboratories

Extramural Clinical

Trials
Appendix IV: Recommendations Made to CDC

and NIH Lyme Disease Programs

Page 26 GAO-01-755 Lyme Disease Programs and Resources

The following tables provide expert recommendations and congressional

appropriations committees’ recommendations made to the Centers for

Disease Control and Prevention (CDC) and the National Institutes of

Health (NIH) Lyme disease programs.

Table 2: Expert Recommendations for the CDC Lyme Disease Program, 1994

Identify “risk factors” and accompanying clinical features that may allow better discrimination of Borrelia burgdorferi infection from

Lyme-like illness.

Give moderate to high priority to the investigation of illnesses clinically similar to Lyme disease in the southeastern United States,

including Texas and Missouri.

Conduct more active and cost effective surveillance in areas at the edges of known endemic communities.

Charge most “users” for the laboratory services and reagents that are provided by the Division of Vector-Borne Infectious Diseases.

Evaluate new tests selectively, with special emphasis on new types of technologies or on antigens or other spirochete components

not previously investigated.

Expand cooperative agreements with scientists from the southern United States to gather information and educate physicians.

Redirect studies pertaining to the ecology of Lyme disease to areas with a potential for Lyme disease expansion.

Increase personnel, especially at the technical level.

Define program priorities more clearly.

Reduce in scope and duration some ongoing basic research projects (e.g., animal models and tick vectorial capability).

Make further efforts to completely report cases of Lyme disease.

Refine the case definition through improved accuracy of diagnosis, making use of two-step testing with standardized reagents.

Intensify and evaluate present control measures.

Test new prevention strategies, including vaccines and control of ticks and wildlife, and make decisions about their effectiveness.

Focus laboratory research more sharply on areas germane to the control efforts.

Continue proficiency testing of commercial diagnostic test products.

Source: CDC.

Appendix IV: Recommendations Made to

CDC and NIH Lyme Disease Programs
Appendix IV: Recommendations Made to CDC

and NIH Lyme Disease Programs

Page 27 GAO-01-755 Lyme Disease Programs and Resources

Table 3: Congressional Appropriations Committees’ Recommendations Related to CDC Lyme Disease Activities

Recommendation Year recommended

Concentrate on states with the highest reported cases of Lyme disease. 1998

Use a portion of resources to address the infrastructure of state and federal health

laboratories.

1997

Expand surveillance efforts to improve the detection and response to emerging

pathogens.a

1996

Continue to develop a substantial pool of scientific expertise and support. 1994

Use funds for programs within the United States. 1993

Reconvene outside panel of experts, including a representative from Lyme Disease

Foundation, to review the case reporting definition.

1993

Work with NIH Rocky Mountain Laboratories to ensure no duplication in research. 1993

Conduct further trials to determine the effectiveness of repellents and other personal

protective measures in reducing the risk of acquiring Lyme disease.

1992

Review the surveillance case definition after the 1991 Lyme disease transmission season,

and adjust accordingly.

1992

Disperse funds as follows: 50 percent toward grants: 75 percent of the grants shall be

made to areas with more than 250 reported Lyme disease cases in fiscal year 1990, and

25 percent of the grants must go toward public education (with a preference to nationwide

education).

1991

Appoint a committee to develop a comprehensive definition that addresses the issue of

the growing population with the classic Lyme disease symptoms and negative blood tests.

1991

Make a report to the Senate Committee on Appropriations in January 1991 regarding

CDC’s new comprehensive definition.

1991

a

Emerging pathogens include Lyme disease.

Sources: House and Senate Appropriations Committees’ reports.

Table 4: Board of Scientific Counselors Recommendations for the National Institute of Allergy and Infectious Diseases

(NIAID) Lyme Disease Program, 1998

Clinical Studies Unit

Make research more hypothesis-driven and less descriptive.

Rocky Mountain Laboratories’ Laboratory of Microbial Structure and Function

Hire additional technical support.

Hire another tenure track entomologist.

Hire another vector biologist.

Rocky Mountain Laboratories’ Rocky Mountain Microscopy Branch

Remove the Facultative Intracellular Bacteria Unit from the branch.

Purchase a new transmission electron microscope.

Source: NIAID.
Appendix IV: Recommendations Made to CDC

and NIH Lyme Disease Programs

Page 28 GAO-01-755 Lyme Disease Programs and Resources

Table 5: Advisory Panel Recommendations for NIAID’s Clinical Studies on Chronic Lyme Disease

Recommendation Year recommended

Clinical studies at the New England Medical Center

Lengthen the study. 1999

Open at least one additional recruitment site, preferably in an endemic area such as New

York or Pennsylvania.

1999

Assess the feasibility of accessing data on positive blood tests from centralized public

health laboratories.

1999

Make every effort to gain the support of advocacy groups. 1999

Hold meetings between investigators and community-based Lyme disease physicians,

who could serve as consultants.

1999

Establish an unblinded oversight committee to review the placebo group. 1999

Incorporate a test for the detection of antigens in urine. 1996

Use standardized neuropsychological tests to monitor research patients. 1996

Only accept patients diagnosed with Lyme disease up to 4 years prior to entry into study. 1996

Require previous documentation of acute Lyme disease by a physician. 1996

Use audiology competency testing during the neuropsychological evaluation. 1996

Clinical studies at the NIH Clinical Studies Unit

Discuss the possibility of posttreatment infection with patients. 1996

Obtain four lumbar punctures from patients. 1996

Use standardized neuropsychological tests to monitor research patients. 1996

Incorporate a test for the detection of antigens in urine. 1996

Source: NIH.
Appendix IV: Recommendations Made to CDC

and NIH Lyme Disease Programs

Page 29 GAO-01-755 Lyme Disease Programs and Resources

Table 6: Congressional Appropriations Committees’ Recommendations Related to NIH Lyme Disease Activities

Recommendation Year recommended

NIAID should expand its research on chronic Lyme disease and make a report during the

1997 budget hearings.

1996

NIAID should expand resources devoted to investigating the etiology of chronic Lyme

disease and its appropriate treatment.

 1994, 1995

NIAID should investigate, in a systematic fashion, whether chronic Lyme disease is an

infectious or postinfectious disorder and report prior to the 1995 hearings on how this will

be accomplished.

1994

NIH should expand Lyme disease research. 1993

NIH should establish NIAID as the lead institute for Lyme disease research. 1993

NIH should establish a pediatric Lyme disease program in the Clinical Studies Unit at the

Bethesda, Maryland, hospital with experiments devoted to chronically infected children.

1993

NIAID should designate one full-time position for coordinating Lyme disease extramural

efforts.

1993

NIH should continue to give high priority to Lyme disease. 1992

NIH should consider funding a center in the Midwest or Southwest to conduct clinical

trials of treatment modalities that would otherwise not be tested.

1991

NIAID and the National Institute of Arthritis and Musculoskeletal and Skin Diseases are

directed to jointly establish and fund an education program that teaches Americans how

to prevent Lyme disease and what to do when stricken by it.

1991

Sources: House and Senate Appropriations Committees’ reports.
Appendix V: Comments From the Department

of Health and Human Services

Page 30 GAO-01-755 Lyme Disease Programs and Resources

Appendix V: Comments From the

Department of Health and Human Services

(201084)
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