Transcript Senate Banking and Insurance Committee Hearing

Pennsylvania House
Human Services
Committee Hearing
House Bill #272
Robert C Bransfield, MD, DLFAPA
President ILADS
President New Jersey Psychiatric Association
Clinical Associate Professor RWJ-UMDNJ Med School
Board of Trustees Medical Society of NJ
August 30, 2011
Relevant Background
 45 year interest in the causes of disease and
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studying the association between infections and
chronic mental and somatic diseases
Organized and operate Microbes and Mental Illness
Internet Discussion Group (400+ international
membership)
American Psychiatric Association: Active in setting
policy for insurance & pharmacy benefit management
issues, access to care, mental health parity, media
Active with German Psychoimmunology Group
Treated thousands of patients with mental symptoms
associated with Lyme/tick-borne diseases
ILADS Mission Statement
 ILADS is a nonprofit, international,
multidisciplinary medical society, dedicated to
the diagnosis and appropriate treatment of
Lyme and its associated diseases. ILADS
promotes understanding of Lyme and its
associated diseases through research and
education and strongly supports physicians and
other health care professionals dedicated to
advancing the standard of care for Lyme and its
associated diseases.
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 In the 1600s Dr Thomas Wynne, William
Penn’s physician and the first speaker for the
Pennsylvania Assemblies who was also my
ancestor treated a smallpox epidemic on the
good ship Welcome threatening the early
immigrants to Pennsylvania. Today we have a
different epidemic—Lyme disease.
Lyme Disease: A Public Health
Failure Causing a Public Health Crisis
 Lyme disease draws critical attention to a
number of problems in our healthcare system.
 A critical issue in the Lyme disease controversy
is how narrow or broad the disease is defined:
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CDC epidemiological definition (it keeps
changing)
Narrow research definition
Broad clinical definition
Patterns of Lyme disease diagnosis and treatment
by family physicians in a southeastern state
 This study examined how often physicians in Georgia
diagnose and treat Lyme disease as well as the
criteria they use to reach a diagnosis of Lyme
disease
 Of 710 responses, 167 physicians treated 316 cases
of Lyme disease without a firm diagnosis. In addition,
125 physicians diagnosed 262 cases of Lyme
disease, 130 without serologic testing and 132 with
serologic testing. Family Physicians in Georgia
diagnose Lyme disease at a rate 40 times greater
than the surveillance case rate reported in Georgia
Boltri JM, Hash RB, Vogel RL. Mercer. J Community Health. 2002 Dec;27(6):395-402
As a psychiatrist I see the failures of
our healthcare system
 If a patient’s symptoms are “medically
unexplained” by current beliefs, the patient is
considered to need a psychiatrist.
 In regard to Lyme disease, the late stage
symptoms are mostly neuropsychiatric.
 I have seen thousands of patients with a broad
spectrum of neurological, cognitive and
psychiatric symptoms, including cases of
suicide, violence, homicide, autism,
developmental disabilities and dementia.
Prevalence of Parent-Reported Diagnosis of Autism
Spectrum Disorder Among Children in the US, 2007
 The weighted current ASD point-prevalence
was 11 per 1000. We estimate that 673,000
US children have ASD.[1]
 According to background information in the
study, the life-time healthcare costs for a
person with autism are estimated to be more
than $16 million.[1]
 Chronic infections may be a contributor in
well over 50% which would be trillions of
dollars.
1. Kogan MD, Blumberg SJ, Schieve LA et al. Pediatrics. 2009 Oct 5.
Chronic Infections Provoke the Immune
System & Cause Chronic Diseases
Infection or
Complex
Interactive
Infections
Pathophysiology
Causing Symptoms
Immune Effects
Th1 & Th2
Sickness Syndrome
(Mediated by Proinflammatory Cytokines IL-1, IL-6, and TNF)
Anhedonia
Malaise
Weakness
Cytokines Induce
Sickness Behavior
Poor
Concentration
Hypersomnia
Anorexia
Social
Withdrawal
Musselman DL, et al. N Engl J Med 2001;344:961-966.
Persistent B burgdorferi Infections
Cause Persistence of Sickness Syndrome
 The IDSA guidelines categorize chronic mood
and cognitive changes associated with tickborne diseases as “subjective and
nonspecific.”
 Basic psychoimmunology demonstrates this
symptom cluster is associated with cytokine
mediated sickness syndrome as a result of
persistent inflammation.
 Persistent B burgdorferi infections cause
persistent immune provocation and persistent
inflammation.
Research & Clinical Observation:
Microbes & TBD Cause Mental Illness
 Thousands of peer-reviewed journal articles
demonstrate the causal association between
infections and mental illness.
 250 peer reviewed scientific articles
demonstrate the causal association between
Lyme/tick-borne disease and mental illness.
 Clinical observation by front line physicians
also supports this view.
Some microbes associated with mental
symptoms & mental illness I
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Spirochetes:
Borrelia afzelii (Lyme disease in UK,
Europe)
Borrelia burgdorferi sensu stricto (Lyme
disease in USA,UK,Europe)
Borrelia garinii (Lyme disease in UK,
Europe)
Borrelia hermsii (Relapsing Fever)
Borrelia turicatae (Relapsing Fever)
Leptospira (Leptospirosis)
Treponema pallidum pallidum (Syphilis)
Bacteria:
Anaplasmas phagocytophilum (Human
Granulocytic Ehrlichiosis)
Bartonella henselae (cat scratch fever)
Bartonella quintana (trench fever)
Bartonella rochalimae (Bartonellosis)
Brucella (Brucellosis)
Chlamydophilia pneumoniae (Chlamydia)
Chlamydophila psittaci (Chlamydia)
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Coxiella burnetti (Q-Fever and "Post-Q
Fever Fatigue Syndrome")
Ehrlichia chaffeensis (Human Monocytic
Ehrlichiosis)
Francisella tularensis (Rabit Fever or
Tularemia)
Haemophilus influenzae (Haemophilus)
Helicobacter pylori
Listeria
Meningococcus (Meningococcal Meningitis)
Mycoplasma fermentans
Mycoplasma pneumoniae
Mycobacterium tuberculosis (Tuberculosis)
Rickettsia. akari (Rickettsialpox)
Rickettsia rickettsii (Rocky Mountain Spotted
Fever)
Rickettsia species (Eastern tick-borne
Rickettsiosis)
Shigella (Shigellosis)
Streptococcus pneumoniae or
Pneumococcus (Pneumonia)
Streptococcus (PANDAS, Sydenham’s
Chorea, St Vitus Dance)
Some microbes associated with mental
symptoms & mental illness II
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Viruses:
Borna virus
Chikungunya virus
Coltiviruse (Colorado Tick Fever)
Coronaviruses
Coxsackie virus
Cytomegalovirus
Enterovirus
Flaviviridae virus (Japanese B encephalitis & Tickborne encephalitis virus)
Hepatitis C virus
Herpes virus family
Human endogenous retroviruses
Human herpesvirus 4 or Epstein-Barr virus
Human immunodeficiency virus
Human T-Cell Lymphotropic Virus Type 1 Influenza
A virus subtype H3N2 (Hong Kong Flu)
Influenza virus
Pandemic Influenza of 1918
Papopavirus
Paramyxovirus (Measles virus)
Parvo B19
Poliovirus
Rabies virus
Rubella
Toga virus
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Varicella zoster virus(Chicken Pox)
Viral meningitis
West Nile virus
XMRV/HGRV
Protozoa:
Plasmodium (Malaria)
Babesia microti (Babesiosis)
Babesia duncani (Babesiosis)
Other Babesia species (Babesiosis)
Leishmania (Leishmmaniasis)
Toxoplasma gondii (Toxoplasmosis)
Parasites:
Blastocystis (Blastocystosis)
Strongyloides stercoralis (Strongyloidiasis)
Taenia solium (Neurocysticercosis or Cysticercosis)
Fungal:
Cryptocococcus
Coccidiomycosis
Histomycosis
Yeast:
Candida albicans (Candidiasis)
Candida dubliniensis
Prion
Variant Creutzfeldt-Jakob
CDC: Emerging Infectious
Determinants of Chronic Diseases
 Non-communicable chronic diseases can stem
from infectious agents.
 Identifying the relationships can affect health
across populations, creating opportunities to
reduce the impact of chronic disease by
preventing or treating infection.
 Infectious agents likely determine more
cancers, immune-mediated syndromes,
neurodevelopmental disorders, and other
chronic conditions than currently appreciated.
 To capitalize on these opportunities, clinicians,
public health practitioners, and policymakers
must recognize that many chronic diseases
may
indeed
have
infectious
origins.
Siobh M. et al (CDC). Emerging Infectious Determinants of Chronic Diseases. Emerging Infectious Diseases. (2006)Vol. 12, No. 7
NIH Human Microbiome Project
 A study researching all of the various microbes
that live in people. The project has already
established that the bacteria in the human
microbiome collectively possess at least 100
times as many genes as the 20,000 or so in the
human genome.
 Bacterial cells outnumber human cells by 10 to 1
 Humans depend on their microbiome for
essential functions, including digestion, leading
microbiologists to conclude that a person should
really be considered a superorganism.
With Emerging Diseases
Think Outside the Box
Always move forward
 Medicine is undergoing a paradigm shift.
 High level researchers and some community
physicians recognize the importance of
infections and immune reactions to them
towards causing many previously
unexplained chronic diseases.
 Just as mathematics shifted from Newton to
Einstein, we need to make a similar shift in
medicine to use more complex models to
understand complex disease.
Categories of disease causation
genetic (inherited alleles)
noninfectious
environmental
(diet, lifestyle, chemicals, radiation)
Paul W. Ewald
parasitic
Disease Models
Bransfield RC. Pediatric Health. April 2009, Vol. 3, No. 2, Pages 125-140.
Persistent Infections & Chronic Chronic
Lyme/Tick-borne
Somatic Mental
Disease Cause…
Illnesses Illness
Theoretical Biology
Pathophysiology
Infectious Disease
Immunology
Psychoimmunology
Psychiatry
Animal Studies
Clinical Observations
International Studies
Epidemiology
X
X
X
X
NA
NA
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Risk of Disease vs. Treatment
 If Lyme disease is
benign, the risk of
the disease may not
outweigh the risk of
treatment.
 If Lyme disease is
serious, the risk of
the disease may
outweigh the risk of
treatment.
Chronic Lyme Disease—The
Standard of Care
ξ
Two equally legitimate but divergent standards of care currently exist for
the diagnosis and treatment of Lyme disease: IDSA guidelines and ILADS
guidelines
1) Johnson L, Stricker RB. Treatment of Lyme disease: a medicolegal
assessment. Expert Rev Anti Infect Ther. 2004 Aug;2(4):533-57.
2) Evidence-based guidelines for the management of Lyme Disease.
Cameron, Horowitz, et al. Expert Review of Anti Infective Therapy 2(1) 2004
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Many doctors in the United States do not follow IDSA guidelines. They
treat for seronegative disease, and treat for extended periods of time. “For
chronic Lyme disease, 57% of responders treat 3 months or more.”
Ziska MH, Donta ST, Demarest FC. Physician preferences in the
diagnosis and treatment of Lyme disease in the United States.
Infection 1996 Mar-Apr;24(2):182-6.
Horowitz R, Phillips S.
One Opinion
 Lyme is difficult to catch, easy to treat, is
never chronic and the current tests are very
reliable
Analysis of Overall Level of Evidence
Behind Infectious Diseases Society of
America Practice Guidelines
 Conclusions More than half of the current
recommendations of the IDSA are based on
level III evidence only. Until more data from
well-designed controlled clinical trials become
available, physicians should remain cautious
when using current guidelines as the sole
source guiding patient care decisions.
Lee DH, Ole Vielemeyer O. Arch Intern Med. 2011;171(1):18-22
Guidelines vs. Clinical Judgment
 Guidelines assist but never replace clinical
judgment. We treat patients, not diseases and
guidelines are based upon scientific studies
that have different degrees of relevance to
the unique clinical circumstances of any given
patient.
Osler: History, Examination &
Clinical Judgment
 "There is no more difficult art to acquire than
the art of observation."
 "The good observer is not limited to the large
hospital.“
 "If you listen long enough, the patient will give
you the diagnosis."
 "Medicine is learned by the bedside and not in
the class room. Let not your conception of
manifestations of disease come from work
heard in the lecture room or read from the
book: see and then research, compare and
control. But see first.“
Lyme Disease (Borrelia burgdorferi)
CDC 2011 Case Definition CSTE
Position Statement Number: 10-ID-06
 “This surveillance case definition was
developed for national reporting of Lyme
disease; it is not intended to be used in
clinical diagnosis.”
CDC http://www.cdc.gov/osels/ph_surveillance/nndss/casedef/lyme_disease_current.htm
Sensitivity/Specificity of Commercial
Two-Tier Testing for Lyme Disease
Study/Year
Sensitivity
Specificity
• Schmitz et al, 1993
66%
100%
Engstrom et al, 1995 55%
96%
• Ledue et al, 1996
50%
100%
• Trevejo et al, 1999
29%
100%
• Nowakowski, 2001
66%
99%
• Bacon et al, 2003
68%
99%
• MEAN TOTAL
56%
99%
Stricker and Johnson BMJ 2007; 335:1008
AIDS testing has a sensitivity of 99.5% Would an AIDS
test with a sensitivity of 56% be satisfactory?
Sensitivity/Specificity of Commercial Two-Tier Testing
for Lyme Disease*
Study/Year
Location
Patients/Controls
Sensitivity
Specificity
Schmitz et al
1993
Engstrom et al
1995
Ledue et al
1996
Tilton et al
1997
Trevejo et al
1999
Bacon et al
2003
Binnicker et al
2008
Steere et al
2008
USA
25/28
66%
100%
USA
55/159†
55%
96%
USA
41/53
44%
100%
USA
23/23
45%
100%
USA
74/38
29%
100%
USA
106/559
67%
99%
USA
35/5
49%
100%
USA
76/86††
18%
99%
TOTALS
USA: 8
435/951
46%
99%
* Limited to studies from USA that included negative controls
† Non-commercial ELISA and Western blot
†† Non-commercial ELISA
Stricker & Johnson, Minerva Med. 2010;101:419-25.
Evidence Based Medicine
 The best evidence available
 Clinical judgment
 Patient considerations
What obstructs forward progress?
 Dr Willie Burgdorfer, who discovered Borrelia
burgdorferi, the spirochete causing Lyme,
stated—“The controversy in the Lyme
disease research is a shameful affair and I
say this because the whole thing is politically
tainted. Money goes to the same people who
have for the last 30 years produced the same
thing—nothing.”*
*Under Our Skin
This raises critical questions
 How much NIH and CDC Lyme disease research
has help patients in the past 30 years?
 Could this disease have been improperly defined
by a group of researchers to maintain the flow of
research grant money to themselves, their
institutions and their collaborators?
Total allocation of funding for tick-borne disease
studies by agency/organization, 2006-2010
Total allocation of funding for tick-borne
disease studies by study type, 2006-2010
The IDSA Lyme disease guidelines
authors had:
 $92,000,000 in NIH & CDC Lyme grants
 $130,000,000 in NIH & CDC Lyme grants to their
institutions & more to other collaborators
 200 Lyme related patents
[The IDSA Lyme disease guidelines review panel
considered income of $10,000 from treating Lyme
patients to be a conflict of interests.]
Finding Answers
 Religion is based upon faith
 Governments are based upon authority or
majority
 Science is based upon evidence
 Medicine is based upon a combination of the
best evidence available, clinical judgment,
patient preferences and ethics
Freedom in Medicine
 Dr. Benjamin Rush, signer of the Declaration of
Independence and personal physician to
George Washington stated—“Unless we put
medical freedom into the Constitution, the time
will come when medicine will organize into an
undercover dictatorship to restrict the art of
healing to one class of men and deny equal
privileges to others: The Constitution of this
Republic should make a special privilege for
medical freedom as well as religious freedom.”
The Solution
 Improve accurate epidemiological capability
 Identifying and dealing with the imbedded
interests that resist forward progress
 A shift towards more clinically based and more
credible research
 Public education, physician education
 Vote YES for House Bill #272
 Thanks for your
attention,
commitment to
preserve the
integrity of our
healthcare system
and your help to
our patients with
Lyme & associated
diseases.