Remarks:
World Wide Lyme Rally & Protest
Friday, May 10, 2013
Union Square
New York City
“Chronic Lyme disease does
not exist”.
There are four
possibilities to explain why a person might hold
this view:
1.They can be ‘dumb as bags
of rocks’.
2. They can be
character-disordered, with excessively rigid
thinking, and perfect,
impenetrable circular logic.
3. They can be corrupt.
4. They can be sociopaths.
One thing is for damn
sure: they are truly lousy clinicians.
In 1991 the Lyme disease
organism, Borrelia burgdorferi, was
grown from the cerebrospinal fluid
of my patient Vicki Logan at
the Centers for Disease Control in Fort Collins,
Colorado
despite prior treatment with intravenous antibiotics. Her case
made the front page of the New York
Times Science Times in
August of 1993.
In 2012, the Embers Rhesus
monkey study demonstrated
conclusively in a primate model closest to
man, that Lyme
infection can persist despite application of intravenous
antibiotics and that animals can be seronegative on antibody
studies despite
harboring persistent active infection.
Lyme disease is the first
infectious disease of truly epidemic
proportions that emerged hand in hand with
another new
phenomenon affecting the health of Americans: the penetration
of
managed care in to the health care market place.
An infection that can be
chronic and require a long-term
treatment approach does not fit the ‘business
model’ of
managed care: predictable premiums, predictable costs,
predictable
profit. With managed care it became
feasible to
control costs by defining away the chronic infectious aspects of
Lyme
disease.
The Infectious Diseases
Society of America Clinical Practice
Guidelines for Lyme Disease which appeared
in 2000 and 2006,
insist that chronic Lyme disease does not exist. These
guidelines have proven an effective
tool for the health
insurance industry to justify denial of reimbursement to
patients for treatments that their doctors prescribe.
Health plans and insurers
and hospitals red flag physicians
not conforming to IDSA guidelines for
sanctioning and often
report them to State Boards of Medical Practice to ‘break
their
knees’. This cowardly and
despicable ‘modus operandi’ is an
assault on physicians’ most prized
possession: professional
autonomy and independent medical judgment.
Hospitals, once proud and independent entities
with
endowments and a tradition of ‘charity care’ have been
‘captured’ by the
insurance industry and are now, often, little
more than ‘corporate profit
centers’.
Health plans do not want
thinking, feeling professionals: they
want ‘trained monkeys’ on a ‘commoditized’ health care
assembly line, following
electronic medical record-prompted
‘algorithms’ designed to maximize corporate
profit.
The Hippocratic Oath has
now become a ‘quaint anachronism’
superseded by a new Corporate Medical Ethic. “He who pays
the
piper calls the tune”.
IDSA guidelines also serve
as a shield for medical neglect,
protecting physicians who fail to diagnose or
treat (or treat
adequately) patients with chronic Lyme disease, who
suffer
irreversible neurologic injury as a result.
In 2008, Connecticut State
Attorney General Richard Blumenthal
undertook an investigation of the way in
which the 2006 IDSA
Lyme guidelines were developed and found significant flaws
in
the IDSA’s guideline development process and many
undisclosed conflicts of
interest.
Attorney General
Blumenthal opted to negotiate a settlement
with the IDSA with the creation of a
Lyme Disease Review Panel
to revisit the IDSA guidelines.
Unfortunately, all panel
members were hand-picked by the IDSA
and physicians earning more than
$10,000/year caring for
persons with Lyme disease were excluded from the
panel. As a
result no physician who
actually cared for persons with chronic
Lyme disease served on the Lyme Review
Panel.
In retrospect, a
negotiated settlement instead of litigation, was a
strategic error because the
review was under the complete
control of the IDSA. Consequently, no meaningful changes in
the
guidelines were recommended. The fox
was guarding the
chicken coop!
However, Attorney General
Blumenthal’s investigation and the
presentations of evidence before the IDSA
Lyme Disease
Review Panel were of some utility.
When the Institute of
Medicine brought forth its monograph on the
development of
trustworthy practice guidelines, it pointed to the IDSA
Lyme
Disease guidelines as an example of a guideline development
process ‘gone
awry’.
Raymond J. Dattwyler,
signatory to the 2006 Lyme disease
guidelines which assert that chronic Lyme
disease does not
exist states exactly the opposite in a United
States patent that
issued almost contemporaneously with the IDSA
Guidelines.
Allen C. Steere, signatory
to the 2006 IDSA Lyme Disease
Guidelines which declare chronic Lyme disease
does not exist,
states exactly the opposite in his published scientific
articles
and private letters. He sought
a correction when his first name
was incorrectly listed in the 1993 Logan
Science Times article
as “Robert’ and advised the Times his opinion had been
incompletely reported and requested it be clarified. According
to the Times correction: “he says
that the small percentage of
patients who have inflammation of the brain
despite standard
antibiotic treatment do have persistent
infection.”
You cannot have it
both ways!
When a physician signs on
to a practice guideline that directly
contradicts their position in their own
published peer-reviewed
journal articles, statements in the public record,
private letters
and in their own United States Patents, does that signify
medical and scientific misconduct?
Additionally, Dr.
Dattwyler served as an expert consultant to
Empire Blue Cross Blue Shield in
its defense against the Logan
lawsuit which sought to compel Empire to cover
the cost of
treatment for chronic Lyme disease.
This was not disclosed in
the published IDSA 2006 Lyme guidelines.
Gary Wormser, lead IDSA
Lyme guidelines author, quashed all
abstracts on chronic Lyme disease from
being accepted at the
2002 International Lyme Conference at the Hyatt Hotel in
New
York City. When I asked him if the
conference was sponsored
by the CDC, he adamantly denied it. This was important
because if it was known to
be a CDC-sponsored event it might
have been possible for legislators to
intervene to open up the
process.
Dr. Wormser either did not
know that the event was CDC-
sponsored (which seems highly implausible) or he
chose to
conceal that fact from me. Materials distributed at the time of
the
conference showed the event was, in fact, CDC-sponsored.
During the conference, whenever attendees
attempted to bring
up the issue of chronic Lyme disease, they were censored,
and
microphones were shut off so their challenges could not be
heard.
When a physician acts in a
way to suppress expression of
opposing views in a government-sponsored
international
scientific conference, does that constitute an abuse of
power?
Does it constitute medical and
scientific misconduct?
Honest science does not need to suppress opposing views.
Vicki Logan and other
patients sued Empire Blue Cross Blue
Shield to cover the cost of needed
treatment. The case was
settled out of
court with terms that were confidential.
Whatever
the settlement was, it did not include Vicki’s right to be
reimbursed for the cost of intravenous antibiotic therapy, which
she needed.
During the litigation, a
deposition under oath was taken by
Empire Blue Cross Blue Shield Senior Vice
President Richard
Sanchez, M.D. He
testified that Empire’s accountants, Deloitte
& Touche, advised Empire
that their review physicians needed
to issue more denials in order to increase
its profitability.
Empire was
transitioning from a not for profit to a for profit
entity. They raised the bar to make it more difficult
for patients
with costly conditions, such as Lyme disease, to get
reimbursement
for treatment. His testimony indicated
that
Empire senior personnel knew that some patients who actually
had Lyme
disease would be denied treatment and that some
would suffer as a result. He said it was ‘rationalized’ that
patients
could appeal their denials and that that was a way that
Empire physicians could
‘sleep at night’. But he also
acknowledged that some patients might be unable to negotiate
the tortuous
appeals process and might ‘fall by the wayside’
and might sustain irreversible
injury as a result.
Empire Blue Cross &
Blue Shield ultimately did transition to a
‘for profit’ entity. Empire executives got ‘golden parachutes’
worth hundreds of millions of dollars in personal profit. Vicki
Logan got a ‘handbasket to hell’.
When patients suffer,
deteriorate neurologically and die due to
corporate decisions, who
is responsible? Is there impunity? Or
is there a penalty?
There’s the case of a 6
year-old Fairfield County, Connecticut
child whose mother pleaded with her
pediatrician to treat for a
fully engorged deer tick attachment on the side of
her neck
Spring of 1995. The
pediatrician refused. Flu-like symptoms
developed that summer, and headache, stiff neck and swelling
of the glands
draining the tick bite site developed in the Fall.
Personality change,
hypersomnolence and later, status
epilepticus developed. Seizures were
so severe that
pentobarbital coma was required to control them. She came
under the care of Charles Ray Jones,
MD, who referred her to
me for a spinal tap.
At the time of the tap, Lyme Western blot in
serum at Stony Brook showed
4/5 CDC-specific IgG bands, but
her ELISA screening test was negative.
Dr. Jones treated her with intravenous
antibiotics. Although
she had sustained
a degree of irreversible neurologic injury
from her illness, she was making
good progress on IV
antibiotics for several months. Intracorp’s review physician
refused to
authorize reimbursement to the family for
continuation of intravenous
antibiotics even though she was
still improving. After cessation of intravenous antibiotics,
intractable
status epilepticus recurred, she was
admitted to a
tertiary care hospital and died within one month. An autopsy
was performed. Both Dr. Charles Ray Jones and I
independently
telephoned the health officer charged with Lyme
disease epidemiology for the
Connecticut Department of Public
Health, pleading with him to take the case. The purpose of our
request was not to punish
any physician, but to learn from the
case. His response to me was: “Well…..what evidence was
there, really, that
this child had Lyme disease?” and
declined
to accept the case.
So, you take the one
physician in Connecticut who cares for all
the children sick with chronic Lyme disease who has never
harmed a child,
but only helped, and put him through an
attempted public crucifixion. And the court allows pediatrician
John
Senechal, who expressed vituperative malice towards Dr.
Jones, to sit on the
Committee determining Dr. Jones’ fate?
But when a physician fails
to treat a child with an engorged deer
tick bite despite a mother’s plea and
fails to recognize Lyme
disease when the
child becomes ill including status
epilepticus
and the child dies
within 30 days of discontinuance of IV
antibiotics made necessary by the
decision of an insurance
company review physician, and two
physicians report the case
to the Connecticut Department of Public Health, you DON’T
investigate?
What is wrong with this picture?
I call on Dr. Jewel
Mullen, Commissioner of the Connecticut
Department of Public Health, to
investigate this case now and
determine why there was a failure
to investigate it in 1997.
I call on Connecticut
Governor Dannel Molloy to direct the
Department of Public Health to disclose
how many hundreds of
thousands of taxpayers’ dollars have been wasted by the
Connecticut Medical Examining Board’s attempt to burn Dr.
Charles Ray Jones at
the stake. Bring this travesty of
justice to
an end!
In 2005 a memorandum of
understanding with the New York
State Department of Health’s Office of Professional
Medical
Conduct (OPMC) was reached through the efforts of
Assemblymen Joel
Miller and Adam Bradley and
Assemblywoman Nettie Meyersohn in conjunction with
Governor Pataki’s Chief Counsel, not to investigate physicians
merely because
they held a minority opinion concerning
diagnosis and treatment of Lyme
disease.
Recently, in New York
State, six physicians who care for
persons with chronic Lyme disease have been
simultaneously
under investigation by the OPMC.
What message does this
send to other physicians? What implications does this have for
persons with chronic Lyme disease to access proper
care
within the State of New York and elsewhere?
If nothing else, it
indicates that a memorandum of
understanding is inadequate to protect
physicians and the
patients with chronic Lyme disease who depend on them for
care.
Force of law is necessary to
accomplish this, and to compel
insurers to pay for treatment their
physicians have determined
is medically necessary for this condition.
Legislation containing
some or all of these elements has been
passed or is currently under
consideration in a number of
States. Insurers
can never be trusted to do the right thing for
patients with chronic
Lyme disease.
Such decisions must
be taken out of the hands of the
insurance industry.
Then, there’s the case of
Jennifer Lilly. She sustained a tick
bite while in western New Jersey, followed by a classic Bull’s
Eye rash, and
severe headache. She was told by a
succession
of physicians she
could
not have Lyme disease because her screening tests for
Lyme disease were
negative and she received no treatment
during the first three years of her
illness. When I saw her, I
diagnosed
Lyme disease based on her history and instituted
treatment at her initial visit. Her Lyme ELISA at SUNY Stony
Brook was still
negative, but her IgM and IgG Western blots
were fully diagnostic. Most likely because of the delay in her
diagnosis, lesions were evident on an MRI of her brain and this
formerly highly
productive woman has had to seek disability.
When the Frederick County,
Maryland Department of Health
contacted me to complete a Lyme disease reporting
form, I
decided to accompany it with a detailed letter which I copied to
Dr.
Thomas Frieden, former New York City Health
Commissioner, and now Director of
the Centers for Disease
Control, since Jennifer’s case was a glaring example of the
deficiencies of
the two-tiered system of Lyme disease testing
recommended by the CDC and
responsible for so much patient
suffering. Dr.
Frieden never personally responded to
my letter.
Presently we have underway
a vast, de facto nation- and world-
wide “Tuskegee Experiment” of untreated or under-treated
chronic Lyme disease.
Neither the United States
Public Health Service, predecessor to
the CDC, nor the medical profession
brought the Tuskegee
Experiment to a halt. Senator Edward Kennedy’s hearings held
in 1972
ended that shameful episode. Moral
force brought the
ignominious
Tuskegee Experiment to an end.
In the year 2000, due to
fortuitous circumstances, and
unbeknownst to Dr. Dattwyler, I gained access to
CDC-funded
experimental methods in his research laboratory for more than
140
specimens of frozen cerebrospinal fluid on my patients.
Whereas only 2% of specimens tested positive
on standard
spinal fluid tests, some 62 % of specimens tested positive on
one
or more of the four experimental assays used.
Ironically, Vicki Logan’s CSF tested more than 7 times higher
than the
positive cut-off for detection of Outer surface protein C
antigen, in the very laboratory
of Empire Blue Cross & Blue
Shield’s own expert consultant.
I asked Laboratory
Supervisor, Priscilla Munoz, how they knew
these methods were valid. She replied that the three
collaborating
research laboratories shared aliquots of samples
and found excellent
reproducibility between the three labs.
The results of these
CDC-funded studies on direct detection of
OspA and OspC antigen and IgG and IgM
borrelia-specific
immune complexes in spinal fluid have never been published.
Why not? Did someone at CDC “deep six” the results of
this
research project? If so, who made
this decision, and why?
I demand the “raw data” from these CDC-funded research
studies, which
have never seen the light of day, be made public
immediately.
Thomas Frieden, as Director
of CDC can ‘set the tone’ for the
agency.
I call on him, to ‘step up to the plate’ and fix the mess
created by CDC. Dr. Frieden can ‘redeem’
the reputation of
CDC, which is composed
of fine physicians and scientists.
Dissociate CDC from the disgraced IDSA Lyme disease
guidelines. Otherwise, step down!
I call on NYS Attorney
General Eric Schneiderman to undertake
an additional, independent, in depth and
far reaching
investigation with subpoena power and testimony under oath,
of the
2006 IDSA Lyme Disease Guidelines and of the health
insurance industry, in order to determine
whether or not, in the
matter of chronic and seronegative Lyme disease, there
has
been collusion to perpetrate a premeditated, systematic and
pervasive
health care fraud upon the citizens of New York State
he has a sworn duty
to protect.
Has anyone here been
shafted by MEDCO??? Investigate
MEDCO!!! When there exist two schools of
thought, you
endorse only that school of thought that maximizes short
term
profit, regardless of individual patient circumstances or the
suffering
that it causes?
Remember A.I.D.S.? Persons with H.I.V. were abused, despised
and
neglected until ACT-UP-activists threw blood on the steps
of St.
Patrick’s Cathedral.
Only then did
things begin to change. Because of that activism,
$2 billion/year has been
expended on A.I.D.S. research and
treatment over the past several decades and real
progress has
been made.
Contrast that with some
$20 million/year spent on Lyme disease
by the Federal government. Why are resources commensurate
with the
threat posed by Lyme disease not being allocated?
Start funding to the
tune of
$2 billion /year for Lyme
and tick-borne diseases and, trust
me,
you’ll see progress!
Federal funds should not
be squandered further on those who
are ideologically committed to the false
proposition that chronic
Lyme disease does not exist.
Paul Starr, who graduated Columbia
College a year ahead of
me, correctly predicted the ‘coming of the corporation’
in his
prescient book “The Social Transformation of American
Medicine”.
But Starr also commented that the future of
American Medicine
is ours to shape by the choices that we make.
Patients have the
Power. But, they must be united and not
squabbling with one another.
They must be pro-active, militant
and resolute.
There are lots of things
patients can do. They can write to their
State Assemblypersons and
State Senators. They can MEET
with their State Assemblypersons
and State Senators. They can
do the same
with their U.S. Congress-persons & Senators
& their states’
Governors.
They can write to
Connecticut Governor Molloy and tell him to
“call off the dogs”!
They can write to Attorney
General Schneiderman with details of
their cases and how they have been mistreated
by insurers
girded by IDSA guidelines that are scientifically, therapeutically
and morally bankrupt and which endorse and enable medical
neglect as a ‘standard
of care’ for persons with chronic Lyme
disease.
They can write to Governor
Cuomo, President Obama and First
Lady Michelle Obama, persons of conscience
and compassion,
urging them to act.
Sometimes, a little
‘rebellion’ is
necessary.
Thank you for your
attention.
Kenneth B. Liegner, M.D.
