The Positive Side of LymeSimilarities and Paradoxes in Chronic Illness

A Medical ConferenceThe Renaissance Vinoy Resort

St. Petersburg, FLSaturday, January 19, 2008

Kenneth J. Friedman, Ph.D.Associate Professor

Department of Pharmacology and Physiology

New Jersey Medical School

Newark, NJ 07103

Introduction 1/5

• Lyme Disease is a disease

• Lyme Disease satisfies the criteria of a disease:– It is an impairment of the normal state of living

or of normal organ function that interrupts or modifies the performance of the vital functions.

– It is manifested by distinguishing signs and symptoms.

Introduction 2/5

• Lyme Disease satisfies the criteria of a disease (continued):– It is a response to environmental factors

(malnutrition, industrial hazards, or climate), or to a specific infective agent (worms, bacteria, or viruses), or to an inherent defect ( a genetic anomaly), or to combinations of these factors.

Introduction 3/5

• Lyme Disease is a neuroendocrine immune disorder (NEID) because:– It can affect the nervous system, the endocrine

system and the immune system.– Its signs and symptoms overlap the signs and

symptoms of other neuroendocrine immune disorders.

Introduction 4/5

• Other NEIDs include:– Chronic Fatigue Syndrome (CFS, CFIDS, ME,

ME/CFS)– Fibromyalgia (FM)– Gulf War Illness/Gulf War Syndrome

(GWI/GWS)– Multiple Chemical Sensitivity Syndrome

(MCSS)

Introduction 5/5

• Lyme Disease is the only disease in this group NEID’s.

• The others are classified as syndromes or illnesses.

• A syndrome is: a group of signs and symptoms that occur together and characterize a particular abnormality.

• An illness is: an unhealthy condition of body or mind.

Disease Syndrome Illness

Lyme Disease + +

CFS + +

FM + +

GWS/GWI + +

MCSS + +

Classification of NEIDs

FDA-Approved Medication

Yes No

Lyme X

CFS X

FM X

GWS/GWI X

MCSS X

Hypothesis: Being a disease, greater advances in Dx, Tx, and Rx will occur for Lyme than other

NEIDs.• Easy/easier diagnosis:

– Known cause/infective agent makes a clinical diagnostic test possible.

• Easier treatment:– Known cause/infective agent permits development of

therapeutic agents.

• Easier access to SSDI– Benefits provided on the basis of clinical data

Hypothesis: Being a disease, greater advances in Dx, Tx, and Rx will occur for Lyme than other

NEIDs.

• Etiology and pathophysiology easier to uncover.– Knowing that Lyme is caused/precipitated by

an infectious agent allows for monitoring the consequences of infection.

• Knowing the causative agent permits the development of an animal model or models.

Method

• Compare the Federal Responses to NEIDs

• Search available data bases of the U.S. government (in December, 2007).

Lead Agencies for NEIDs

Illness Lead Federal Agency

Lyme Disease NIH/NIAID/CDC (National Institute of Allergy and Infectious Diseases/Centers for Disease Control and Prevention

CFS NIH/ORWH (Office of Research for Women’s Health)

FM NIH/NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases)

GWS/GWI DOD/VA

MCSS NIH/NIEHS (National Institute of Environmental Health Sciences)

Support for Lyme Disease 1/5

• From the GAO Report to Congress of June, 2001 (LYME DISEASE HHS Programs and Resources):– Over the past 10 years,

allocations for Lyme disease have increased slightly at CDC

– obligations for Lyme disease at NIAID have grown in inflation-adjusted dollars, from about $124,000 in FY 1991 to $3.5 million in fiscal year 2000.

Support for Lyme Disease 2/5

• From the GAO Report (continued):NIH carries out its Lyme disease

activities primarily at NIAID but also at other institutes: 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).

Support for Lyme Disease 3/5

• From the GAO Report (continued):

– NIAID conducts clinical research related to Lyme Disease at the Clinical Studies Unit on the NIH campus

– NIAID conducts laboratory research at the Rocky Mountain Laboratories in Hamilton, Montana.

Support for Lyme Disease 4/5

From the GAO Report (continued)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

Support for Lyme Disease 5/5

From the GAO Report (continued)

NIH has funded research on:• tick ecology and control• the relationship between maternal Lyme

disease and congenital abnormalities in newborns.

Support for CFS 1/5

• CFS is homeless at the NIH - There is no institute affiliation.

• There is no intramural CFS research at the NIH.• The Office of Research on Women’s Health and

co-sponsoring Institutes and Centers (IC’s) solicit grant applications proposing to examine etiology, diagnosis, pathophysiology and treatment.

• NIH encourages ongoing, investigator research through Program Announcements (PAs).

Support for CFS 2/5

The CDC conducts CFS Research. From the CDC website:

• “CDC has conducted a study of CFS and similar illnesses in 13 counties in Georgia. Interviewers telephoned a randomly selected sample of 17,000 households and asked the selected households a short set of questions to identify household members who may have CFS and similar illnesses.”

Support for CFS 3/5

The CDC conducts CFS Research. From the CDC website (continued):

“Results from this study are being prepared for publication.” – The results have been published. – The data was sent to multiple groups

outside the CDC for analysis.– Multiple interpretations of data were

obtained. – Articles are difficult to retrieve.

Support for CFS 4/5

From GAO report of June 2000:

• “The Centers for Disease Control and Prevention (CDC) CFS program for the past 12 years has focused largely on the prevalence and the causes including the search for infectious and immunological abnormalities.”

Support for CFS 5/5

From GAO report of June 2000

• “The National Institutes of Health (NIH) has focused on CFS' effects on bodily systems and possible causal agents.”

• “At CDC, the lengthy and uncertain process for allocating CFS funds has delayed particular projects.”

• “CDC's redirection of funds has resulted in reductions in CFS research funding.”

Support for FM 1/2

From the NIAMS website:

• NIAMS sponsors researchers who are studying:

– Why people with FM have increased sensitivity to pain.

– The role of stress hormones in the body.

– Medicines and behavioral treatments.

– Whether there is a gene or genes that make a person more likely to have FM.

Support for FM 2/2From the NIAMS website:

• Goal is to:– Promote research that will improve

understanding of the disease

– Identify critical processes and mediators

– Establish a rational basis for new and effective treatments.

Author comment:

• Last initiative was a request for (research) applications by Feb. 10, 1994.

Support for GWI 1/9

From a GAO report of June 1, 2004:

• “The federal focus on Gulf War-specific research has waned.”

• “In recent years,VA and DOD have decreased their expenditures on Gulf War illnesses”

• “Interagency committees formed by the VA to coordinate federal Gulf War illnesses research have been dissolved or have become inactive.”

Support for GWI 2/9

From a GAO report of June 1, 2004:• This overall decrease in federal funding

was paralleled by a change in federal research priorities.

• In October 2002, the VA announced plans to commit up to $20 million for research into Gulf War illnesses and the health effects of other military deployments.

• As of April 2004, one new Gulf War illnesses research project, for $450,000, was funded under this program announcement.

Support for GWI 3/9

From a GAO report of June 1, 2004:

• “Although the DOD has historically provided the majority of funding for Gulf War illnesses research, DOD officials stated that their agency currently has no plans to continue funding new Gulf War illnesses research projects.”

Support for GWI 4/9

From a GAO report of June 1, 2004:• “The most recent interagency

research subcommittee, which is under the Deployment Health Working Group (DHWG), has not met since August 2003, and as of April 2004, no additional meetings had been planned.”

Support for GWI 5/9

From a GAO report of June 1, 2004:

“The VA has not reassessed the extent to which the collective findings of completed Gulf War Illnesses research projects have addressed the 21 key research questions developed by the RWG.”

Support for GWI 6/9

From a GAO report of June 1, 2004:

“No reassessment of these research questions has been undertaken to determine whether they remain valid, even though about 80 percent of federally funded Gulf War illnesses research projects now have been completed.”

Support for GWI 7/9

From a GAO report of June 1, 2004:

“In 2000, we reported that without such an assessment, many underlying questions about causes, course of development, and treatments for Gulf War illnesses may remain unanswered.”

Support for GWI 8/9Figure 4: Funding for Gulf War Research Projects, Fiscal Years 1994-2003

Support of GWI 9/0

Office of the Deputy Assistant Secretary of Defense Force Health Protection & Readiness Policy & Programs contacted in January, 2008:

• “There is nothing much beyond 2004.”• “Emphasis is on PTSD and other things related to

the current fiasco.”  

Support for MCSS 1/5

• NIEHS website for MCSS is inactive – no information is available.

• No other source of federal funding found.

• No GAO report found.

Support for MCSS 2/5

• NIEHS is sponsoring RFA-ES-07-008

– Release Date:  October 5, 2007

– Earliest Anticipated Start Date: April 1, 2009

– applications from qualified institutions for support of Environmental Health Sciences (EHS) Core Centers.

Support for MCSS 3/5

From the RFA:

• A Core Center Grant is an institutional award to support centralized scientific resources and facilities shared by investigators with existing research projects.

Support for MCSS 4/5

From the RFA:• intended to enhance the ability of scientists

working the field of environmental health sciences to identify and capitalize on current and emerging opportunities that will lead to outstanding research advances to improve our understanding of the relationship between environmental exposures and both human biology and human disease.

• NIEHS plans to award up to $5 million in FY 2009 to fund three grants in response to this Funding Opportunity Announcement (FOA).

Support for MCSS 5/5

• Response of Dr. Marian C. Johnson-Thompson, Office of the Deputy Director NIEHS, Director of Education and Biomedical Research Development (January, 2008):– No specific MCCS RFA– No specific MCCS Program– Only a few grants looked at chemical

hypersensitivity and MCS– In 2007, possibly $2 million spent

Estimates of Funding for NEIDs2003-2006 Actual Data/2007-2008 Estimated

Data from NIH except GWI/GWI from 2004 GAO Report

0

5

10

15

20

25

30

35

2003 2004 2005 2006 2007 2008

Fiscal Year

Do

llar

s in

Mil

lio

ns

CFS

FM

Lyme

GW

Discussion 1/3

• The federal response to NEIDs is varied and spread over several agencies.

• Lyme Disease, in comparison to other NEIDs, has made the most progress in terms of Dx, Tx and Research. (The positive side of Lyme.)

• NIAID, as the lead agency for Lyme, lists the most ambitious agenda for dealing with any NEID.

Discussion 2/3• As predicted, Lyme is the only NEID for

which animal models exists.• The existence of an animal model should

accelerate elucidation of the pathophysiology, treatment and drug development

• The ability of the Federal Government to respond to Lyme is perhaps related to Lyme being a disease (having a known cause).

Discussion 3/3

• The Federal government’s response to NEID syndromes is less effective.

• Alternative strategies for NEID research and patient care exist (see “Fish or War” http://monkeyswithwings.com/fishorwar.html)

• The Federal government has in the past expressed concern and responded to patient advocate groups (e.g. Lyme, CFS, and GWS)

• Alternative strategies should be implemented.

Alternative Strategies in Progress

• Establishment of a Congressional Caucus to advocate legislation and support of research, patient care and education (started for CFS)

• Establishment of a NEID Center of Excellence at a university affiliated medical school in Florida.

Future Alternative Strategies

• Establishment of state-supported Centers of Excellence in multiple states.

• Establishment of federally-supported Centers of Excellence geographically distributed throughout the U.S.

• Establishment of an umbrella organization representing all NEIDs for the purpose of more effective lobbying: the NEID’s NAG – NEID Advisory Group.

And finally…..

• “One Community,

• One Cause,

• One Voice”– Created for P.A.N.D.O.R.A as a slogan to

unite the CFS Community of Florida.

– Can it; should it be used to unite the NEID community nationwide?