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Health Care Reform
Health Care Reform
involving federal health agencies and medical societies.
am writing to tell you of certain practices of the medical trade that
are used for health care
so that HMO’s and other health insurers can minimize their
costs and increase their
One outcome of this method of patient abandonment is
that the patients can be
to the extent that they become wards of the government.
This results in increased
and assistance costs for state and federal governments
resulting from the dereliction of
responsibilities by insurers. This is wrong and something that
the nation doesn’t need
will try to keep this as brief and simple as I can. It is a complex
topic. If there is a need for more
I can provide it.
“Evidence-based medicine” as a
foundation for health care denials
A core tool
for the manipulation of medical
standards is the use of “evidence-based medicine.”
can involve such tactics basing recommendations on highly
selective and exclusionary
as well as using disease definitions that are so
restrictive, few can meet the definition.
medicine results in clinical practice guidelines. The
authors of these guidelines
have massive conflicts of interest including, for example,
arrangements with pharmaceutical
interests in test kits and vaccines, and financial
relationships with HMO’s and other
fact, evidence-based medicine is not necessarily based on medicine.
based on the opinions of the authors and influenced by the
conflicts mentioned above and
conflicts of interest.
clinical practice guidelines can become clinical practice “rules”
or mandates resulting in
being denied the freedom to treat in the best interests of
the patient. Physicians who do
conform to guidelines can be reprimanded in one form or another
including complaints to
boards and possible loss of license to practice.
case of Lyme disease.
am most familiar with Lyme disease so I will cite some specifics
relating to this example. Lyme
may well be the most corrupted of any medical condition.
disease clinical practice guidelines have been issued by the
Infectious Diseases Society of
(IDSA) and, more recently, by the International Lyme and
Associated Diseases Society
My focus will be on the IDSA guidelines since this is the
basis for Lyme denials used
HMO’s and insurers ( http://www.journals.uchicago.edu/doi/full/10.1086/508667
issues many clinical practice guidelines and I would like to make
it clear that I do not
all of IDSA’s guidelines to be corrupted.
most recent Lyme disease guidelines (2006) are under review
because of an investigation
Connecticut’s Attorney General (http://www.ct.gov/ag/cwp/view.asp?a=2795&q=414284).
latest version of the IDSA guidelines covers some coinfections of
Lyme disease as well.
were 14 authors of the guidelines, 11 of these authors promoted
as “experts” on Lyme
The substantial conflicts of interest of most of these authors
were not revealed in the
section of the guidelines. These undisclosed conflicts
included interests in private
payments by pharmaceutical companies and HMO’s and health
research, and financial interests in Lyme disease testing and
vaccines. Of course, the lawsuits
very large number of complaints against some of the authors
relating to medical malpractice
damage from Lyme vaccines also was not mentioned. While disclosure,
per se, does not
the problems of conflicts of interest, it would at least provide
some transparency. The
problem is that conflicts of interest can influence
recommendations which, in turn,
take on the force of law.
IDSA authors claim that a comprehensive review of medical
literature was undertaken and
405 references were used for Lyme disease. In fact, only 337 of
these references relate to
disease. Of these, over 50% were written by the authors
themselves. Most of the
were based on no more than the “expert opinion” of the
the time of the drafting of the guidelines, there were over 7,000
citations to Lyme disease in
National Libraries of Medicine. Studies that contradicted the
opinion of the authors were
CDC employee with patent interests in Lyme disease, Barbara J.
Johnson, is credited as having
a consultant in the formulation of the IDSA guidelines.
and misinformation about Lyme disease
net effect of the IDSA guidelines is to characterize Lyme disease
in a manner that makes
more restrictive and, therefore, minimize the apparent
prevalence of the disease.
more important impact is to severely limit treatment. IDSA
claims that a few weeks of
completely cures any stage of the disease and that any
ongoing symptoms after
are not due to Lyme disease. This has been completely
discredited in both foreign and
research and by the clinical experiences of doctors who treat
Lyme disease with long-
antibiotics. Kaiser Permanente is a prime example of an HMO that
adheres exclusively to
IDSA guidelines. Doctors who do not conform are reprimanded. This
also applies to
doctors who try to help patients by cooperating with
treatment plans ordered by an
Lyme specialist, who the patient sees at their expense.
disease can be expensive to treat and many have become destitute
and homeless because of
expenses and inability to work. Through welfare payments and
other assistance, they
become dependent on the government for support. The IDSA
guidelines enable HMO’s and
insurers to escape expense and liability and transfer costs to
the government. Moreover,
panelists themselves can escape culpability since many do not have
a clinical practice subject
malpractice and, in the event that they do, they can refer to their
“guidelines” as a “standard of
and use their cohorts as “expert witnesses”.
disease is also trivialized by IDSA and many related symptoms, such
as serious cardiac
have been excluded in the guidelines. Complications of
improperly treated Lyme
can and do cause death and permanent disability.
conflicts of interest of federal health agencies.
authors of the IDSA guidelines are empowered by the National
Institutes of Health (NIH)
the Centers for Disease Control and Prevention (CDC).
former NIH Lyme disease program manager was Phillip J. Baker.
Allocations for Lyme
were extremely biased. Most of the NIH funding went to certain
authors of the Lyme
their associates, and their institutions. Some of the
research funded appears to have
contrived to reach desired outcomes. Some of these studies have
been heavily criticized. As
reward for his allegiance, Dr. Baker was made the president of the
American Lyme Disease
(ALDF) when he retired. Some guideline authors are
“scientific advisors” to the
The ALDF is known by advocates as an HMO friendly, anti Lyme
Burgdorfer, formerly with the NIH and for whom the Lyme bacterium
was named, made
observation that after 30 years (of research by the Lyme cartel) we
still know little or nothing.
Burgdorfer, who is likely the world’s most expert authority in the
characteristics of the Lyme
believes that late-stage cases of Lyme disease require
long-term antibiotics; contrary
the recommendations of the IDSA guidelines.
CDC has endorsed the IDSA Lyme guidelines on their public
information page. The CDC
many employees who are also members of IDSA, a private
organization. In addition, some of
authors were former CDC employees and have close ties to the CDC.
One question is whether
CDC should be officially endorsing these guidelines, especially
given their controversy. The
itself has massive conflicts of interest with regard to Lyme
disease. Much of this was made
by the passage of the Bayh-Dole Act in 1980. This allowed
intellectual property rights to
held by those performing research funded by the federal government.
As a result, the CDC and
of its employees involved in Lyme disease have patent interests
in vaccines and Lyme
testing methods. The CDC also assigned rights to a Lyme vaccine
Corporation. Approval by the CDC virtually insures a large
market for a vaccine.
content of the CDC’s Lyme disease information has been diluted to
the point that it is of little
to the public and medical practitioners. During vaccine
development, the definition of
disease was altered to one more “vaccine friendly.” The purpose
was to limit the disease
so as to maximize the apparent efficacy of the vaccine in
the end, the SmithKline Beecham vaccine turned out to have serious
adverse effects, including
and was withdrawn from the market. Evidence suggests the CDC
knew of these side
before the vaccine was approved. A logical conclusion is that
the CDC and its employees
more concerned about protecting their financial health than the
misinformation and attempts to eliminate ILADS guidelines.
CDC has standards for Lyme disease testing for surveillance
purposes that are highly
and that very few, even with proven Lyme disease, can meet.
The result is that Lyme
is vastly underreported, even in areas where it is recognized
and where physicians are
aware. The serologic tests are touted to be highly accurate when,
in fact, they are not,
when performed by large high volume laboratories. The CDC
does caution that the
testing criteria for surveillance purposes should not be used
for diagnosis. But they are. The
guidelines promote the use of the restrictive CDC testing criteria
for diagnostic purposes.
the IDSA guidelines are endorsed by the CDC and touted on the
CDC’s Lyme disease
web page, the alternative ILADS Lyme guidelines are given
a closed meeting involving high level CDC employees and the
president of IDSA at the time,
Stamm, a directive was approved to eliminate “rogue” Lyme
disease guidelines. Although
were not mentioned in the released minutes of this meeting, this
could have only referred
the alternative patient friendly guidelines issued by ILADS.
methods for adherence
to IDSA guidelines.
of competent and credible Lyme disease specialists who treat
in accordance with
guidelines is not uncommon. Investigations are usually conducted
by medical boards that
on IDSA guidelines and use IDSA “Lyme disease experts” as
witnesses. There are a number
examples of this. In many states, the environment for Lyme
specialists is so toxic; patients
travel to other states for diagnosis and treatment. Some states,
such as California, have
legislation to protect legitimate Lyme physicians from
essence, the enormous power of IDSA combined with endorsement by the
CDC was used to
“competitors” out of business and left patients whose insurers
relied on the IDSA Lyme
with no treatment options. This abuse of monopoly powers is
one of the factors that
to the antitrust investigation of IDSA and question the process
used to develop its Lyme
It was during this investigation that numerous and
significant conflicts of interest by
panel were discovered.
guidelines, even corrupted ones, are a tool for controlling
medicine through the
of medical decision making. Practice guidelines are
central to the profitability of
and health insurers.
David Eddy, senior advisor to Kaiser Permanente, stated that “if
the fight to control health
costs is to be successful, it will have to address [the decisions
physicians make about
(Eddy DM. Three Battles to Watch in the 1990's. JAMA.
1993; 270(4): 520-26). Dr.
went on to say “[i]t would not be stretching things too far to say
that whoever controls
policies controls medicine.” (Eddy DM. Clinical Decision
Making: From Theory to
Practice Policies—What Are They? JAMA. 2000; 263(6):
an altruistic point of view, ethically and competently derived
guidelines could benefit
as well as control costs. But when guidelines are driven by
interests that are not aligned
the public interest, as they are when they are exclusionary of
divergent opinion and permit
of interests, they become tools of the pharmaceutical and
insurance industries. Thus,
observations made by Dr. Eddy can have very negative consequences.
General’s IDSA Lyme guideline antitrust investigation
Connecticut Attorney General concluded its investigation finding
that the IDSA Lyme panel
substantial conflicts of interest, excluded divergent opinion, and
This panel created guidelines that took on the force of law
and were treated as
by insurers, medical boards and courts of law. Laws are
generally adopted through
public debate with input from all affected stakeholders. But the
IDSA guidelines panel did
include community physicians, physicians from the International
Lyme and Associated
Society, and Lyme patients (http://www.ct.gov/ag/cwp/view.asp?a=2795&q=414284).
Connecticut Attorney General forced the IDSA to put together a new
panel free from
of interest to review the guidelines adopted in 2006, permit
opposing scientific evidence
be submitted and considered by the panel, and to have a public
hearing with presentations that
air live over the Internet. Notwithstanding this settlement, it is
apparent that the IDSA is
on protecting its professional turf at the expense of patient
health care. It has made this
by stacking the panel with IDSA members and research academics
and excluding all
physicians and members of ILADS. One panel member has been
from the panel and another is under scrutiny—both because they
had drafted previous
in contravention of the settlement agreement with the
Attorney General. Inclusion of
viewpoints is necessary for treatment guidelines to include
options for patients.
review is still in process.
independent commentary on the applicability of antitrust law in the
development of clinical
guidelines is found at http://lyme.kaiserpapers.org/pdfs/lymeantitrust.pdf
I was a
victim of the IDSA/CDC guidelines.
saga with Lyme disease started on a 1994 road trip to Oregon and
California with my dog,
We were both infected, most likely at a highway rest area. After we
returned home, we both
the distinctive expanding circular rash considered the “hallmark”
sign of Lyme disease. Mine
on my chest and reached about a foot in diameter. I did not know
about Lyme disease at the
and did not realize the significance of the rash. The rash
eventually faded and I forgot about
next the six years I was infected but did not know it, I saw
four primary care doctors, two
one allergist, and two cardiologists. I saw each of
these doctors multiple times
connection with my Lyme symptoms. This does not include the numerous
times I went to ER
which my resting heart rate was recorded at over 250 beats per
minute. An MRI of my
showed lesions consistent with neurological Lyme. In a span of
about 18 months, I had 11
catheter procedures to determine the cause and try to correct
my cardiac irregularities.
it was clear that Kaiser could not help, it took me about an hour
on the Internet to research
symptoms and learn the significance of the rash I had. The findings
indicated Lyme disease.
I saw an infectious diseases doctor at Kaiser. He ordered
the cheap and unreliable
Lyme “screening” test according to the IDSA guidelines. The
sample was sent from
to a contracted lab on the East Coast. The interval between
blood draw and analysis was
than two weeks, which may have rendered the sample worthless
because of degradation. (I
learned that Kaiser has been known to send East Coast samples to
labs in the West.) Strain
between the East Coast and West Coast can also be a factor
in test outcomes.
result of my test was, of course, negative. The infectious diseases
doctor dismissed my rash.
wrote a two-page report justifying his denial. This was not a casual
dictation. It took about
months for the report to appear in my medical record. In it, he
even fabricated information.
entry read that I believed in Lyme “conspiracists,” something I
never said and never brought
This was intended to question my mental state.
a Kaiser neurologist tried to help me. He ordered the ELISA and
Western Blot tests
Kaiser and a Western Blot test by an independent lab
specializing in tick-borne diseases.
had to pay for the independent lab test. I did not trust the lab
was denied his order to have the Western Blot tests done since the
for a positive ELISA before the more expensive Western Blot
tests could be done. Kaiser
shipped the sample to the East Coast and again my ELISA was
Western Blot test that was done at the specialty lab came back
highly positive with specific
for Lyme. The neurologist wrote another infectious disease
doctor that these test results
not consistent with Kaiser’s negative ELISA test. The infectious
diseases doctor replied that
ELISA is highly accurate (a false IDSA/CDC claim) and I could not
possibly have Lyme
In a letter to the chief of infectious diseases, I asked about
the significance of the rash I
He wrote back while I may have had Lyme disease, I no longer had
it. In his opinion, it
itself (although I had ongoing symptoms). The positive Western
Blot was not in my record.
I was able to change health plans and see a Lyme specialist in
San Francisco. There were
doctors competent in Lyme disease in my region. My life-threatening
within a month of antibiotic treatment (although not all
cardiac symptoms resolved). It
about four years of antibiotic treatment to become functional
was so much damage to my heart that most cardiologists
recommended a heart transplant.
was not an option for me because of the immune suppressing drugs
required. Ultimately, a
and expensive open heart surgery was done at Stanford
costs associated with my Lyme disease were in the many hundreds of
thousands of dollars.
paid for the open heart surgery. The cost of the loss of 10
years of my life, during
time I was unable to work, is incalculable. My companion, Bo, had
to be euthanized.
end result of the IDSA/CDC misinformation about Lyme disease is
that most doctors are
ignorant about Lyme disease believing it is rare or
nonexistent in their areas and that
disease is “hard to catch and easy to cure”. Even using figures
that greatly understate the
of the disease, Lyme far outnumbers AIDS in terms of disease
frequency. Most doctors
not question the information provided by the CDC.
CDC information has never been subjected to peer review as required
under the Office of
and Budget (OMB) Final Information Quality Bulletin for Peer
Patient advocacy groups have requested a peer review by the
CDC and have been
This review should be ordered through a government mandate.
NIH has conducted studies that are being relied upon to deny
patients treatment—yet the data
these studies has not been made available for analysis by
others although these studies
been sharply criticized. A study funded by the NIH that used
non-human primates and was
more than 6 years ago has never been published. This publicly
funded project may yield
information on Lyme disease and persistence. This data has not
been released and should be
is difficult to get funding for Lyme disease from non-government
sources because there is no
money in treating the disease, which relies on generic
antibiotics. However, Lyme disease
be a goldmine for pharmaceutical companies that have medications to
treat and mask
ongoing symptoms rather than curing the disease itself. In the
long run, this approach
cost far more and the patient does not achieve wellness.
simple truth is that some government health agencies have operated
in a corrupt fashion,
the interests of a handful of researchers, suppressing
scientific evidence and
patients as not even being “on the agenda”. Lyme patients
and their physicians
have no voice in Lyme disease funding or health care policy
federal government must step in to correct these injustices. State
governments are limited in
they can do, particularly with regard to federal health agencies.
And all or most state
of health are dominated by CDC/IDSA information.
government health agencies and private medical societies,
HMO’s should be scrutinized.
additional information on Lyme disease and some of the corruption
involved, I highly
“Cure Unknown: Inside the Lyme Disease Epidemic” by Pamela
Weintraub and the
winning film documentary about Lyme disease, “Under Our Skin.”
JD, MBA, maintains a blog that discusses the
medical-legal-ethical issues surrounding
disease, that include treatment guidelines, the Connecticut
antitrust action against the
and the interplay of universal health care at http://tinyurl.com/lymepolicywonk.
health care reform plan should give careful consideration to the
dangers of inappropriately
and developed clinical practice guidelines and their
application in health care reform
The potential misapplication of medical guidelines can result
in much greater costs to
These include increased disability and government subsidies
resulting from patient
loss of national productivity due to increased numbers of
sick people unable to
and the greater costs of long term symptomatic treatment and
procedures rather than the treatment of the disease itself.
of medical corruption is essential to the success of any
health care reform plan.
you very much for the opportunity to write this letter.
In Copyright since 2000