Lyme Disease: HHS Programs and Resources (22-JUN-01, GAO-01-755).
								 
The Centers for Disease Control and Prevention (CDC) and the	 
National Institutes of Health (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 patient and practitioner	 
educational materials. CDC has initiated most activities	 
recommended by external reviewers and congressional		 
appropriations committees regarding changes to its programs. 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. Over the past ten 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 seven percent,
from $6.9 million to $7.4 million in inflation-adjusted dollars  
from fiscal years 1991 through 2000. In contrast, the NIH	 
increase in obligations for Lyme disease has been steady and	 
relatively large, at 99 percent.				 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-01-755 					        
    ACCNO:   A01240						        
  TITLE:     Lyme Disease: HHS Programs and Resources		      
     DATE:   06/22/2001 
  SUBJECT:   Diseases						 
	     Medical education					 

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GAO-01-755
     
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
Beecham 10 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.

10 SmithKline 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.

11 Babesia 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.

12 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.

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 Inf ectious 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 syndrome
13 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.

13 Post- 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- borne 1 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 rate a

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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