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President Barack Obama
White House
1600 Pennsylvania Ave NW
Washington, DC 20500
Re: Health Care Reform

Re: Health Care Reform
       Medical corruption involving federal health agencies and medical societies.


Dear President Obama,

I am writing to tell you of certain practices of the medical trade that are used for health care
denials so that HMO’s and other health insurers can minimize their costs and increase their
profitability. One outcome of this method of patient abandonment is that the patients can be
debilitated to the extent that they become wards of the government. This results in increased
welfare and assistance costs for state and federal governments resulting from the dereliction of
medical responsibilities by insurers. This is wrong and something that the nation doesn’t need
right now.

I will try to keep this as brief and simple as I can. It is a complex topic. If there is a need for more
information, 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.”
This can involve such tactics basing recommendations on highly selective and exclusionary
references as well as using disease definitions that are so restrictive, few can meet the definition.
Evidence-based medicine results in clinical practice guidelines. The authors of these guidelines
can have massive conflicts of interest including, for example, arrangements with pharmaceutical
companies, interests in test kits and vaccines, and financial relationships with HMO’s and other
health insurers.

In fact, evidence-based medicine is not necessarily based on medicine. Most recommendations
are based on the opinions of the authors and influenced by the conflicts mentioned above and
other conflicts of interest.

These clinical practice guidelines can become clinical practice “rules” or mandates resulting in
physicians being denied the freedom to treat in the best interests of the patient. Physicians who do
not conform to guidelines can be reprimanded in one form or another including complaints to
medical boards and possible loss of license to practice.

The case of Lyme disease.

I am most familiar with Lyme disease so I will cite some specifics relating to this example. Lyme
disease may well be the most corrupted of any medical condition.

Lyme disease clinical practice guidelines have been issued by the Infectious Diseases Society of
America (IDSA) and, more recently, by the International Lyme and Associated Diseases Society
(ILADS). My focus will be on the IDSA guidelines since this is the basis for Lyme denials used
by HMO’s and insurers ( ).
IDSA issues many clinical practice guidelines and I would like to make it clear that I do not
consider all of IDSA’s guidelines to be corrupted.

IDSA’s most recent Lyme disease guidelines (2006) are under review because of an investigation
by Connecticut’s Attorney General ().
The latest version of the IDSA guidelines covers some coinfections of Lyme disease as well.
There were 14 authors of the guidelines, 11 of these authors promoted as “experts” on Lyme
disease. The substantial conflicts of interest of most of these authors were not revealed in the
disclosure section of the guidelines. These undisclosed conflicts included interests in private
companies, payments by pharmaceutical companies and HMO’s and health insurers, payments
for research, and financial interests in Lyme disease testing and vaccines. Of course, the lawsuits
and very large number of complaints against some of the authors relating to medical malpractice
and damage from Lyme vaccines also was not mentioned. While disclosure, per se, does not
solve the problems of conflicts of interest, it would at least provide some transparency. The
fundamental problem is that conflicts of interest can influence recommendations which, in turn,
can take on the force of law.

The IDSA authors claim that a comprehensive review of medical literature was undertaken and
that 405 references were used for Lyme disease. In fact, only 337 of these references relate to
Lyme disease. Of these, over 50% were written by the authors themselves. Most of the
recommendations were based on no more than the “expert opinion” of the panel.

At the time of the drafting of the guidelines, there were over 7,000 citations to Lyme disease in
the National Libraries of Medicine. Studies that contradicted the opinion of the authors were
eliminated.

A CDC employee with patent interests in Lyme disease, Barbara J. Johnson, is credited as having
been a consultant in the formulation of the IDSA guidelines.

Trivialization and misinformation about Lyme disease

One net effect of the IDSA guidelines is to characterize Lyme disease in a manner that makes
diagnosis more restrictive and, therefore, minimize the apparent prevalence of the disease.
Another more important impact is to severely limit treatment. IDSA claims that a few weeks of
antibiotics completely cures any stage of the disease and that any ongoing symptoms after
treatment are not due to Lyme disease. This has been completely discredited in both foreign and
domestic research and by the clinical experiences of doctors who treat Lyme disease with long-
term antibiotics. Kaiser Permanente is a prime example of an HMO that adheres exclusively to
the IDSA guidelines. Doctors who do not conform are reprimanded. This also applies to
Permanente doctors who try to help patients by cooperating with treatment plans ordered by an
independent Lyme specialist, who the patient sees at their expense.

Lyme disease can be expensive to treat and many have become destitute and homeless because of
medical expenses and inability to work. Through welfare payments and other assistance, they
then become dependent on the government for support. The IDSA guidelines enable HMO’s and
health insurers to escape expense and liability and transfer costs to the government. Moreover,
the panelists themselves can escape culpability since many do not have a clinical practice subject
to malpractice and, in the event that they do, they can refer to their “guidelines” as a “standard of
care” and use their cohorts as “expert witnesses”.

The disease is also trivialized by IDSA and many related symptoms, such as serious cardiac
outcomes, have been excluded in the guidelines. Complications of improperly treated Lyme
disease can and do cause death and permanent disability.

The conflicts of interest of federal health agencies.

These authors of the IDSA guidelines are empowered by the National Institutes of Health (NIH)
and the Centers for Disease Control and Prevention (CDC).

The former NIH Lyme disease program manager was Phillip J. Baker. Allocations for Lyme
disease were extremely biased. Most of the NIH funding went to certain authors of the Lyme
guidelines, their associates, and their institutions. Some of the research funded appears to have
been contrived to reach desired outcomes. Some of these studies have been heavily criticized. As
a reward for his allegiance, Dr. Baker was made the president of the American Lyme Disease
Foundation (ALDF) when he retired. Some guideline authors are “scientific advisors” to the
ALDF. The ALDF is known by advocates as an HMO friendly, anti Lyme patient organization.

Willy Burgdorfer, formerly with the NIH and for whom the Lyme bacterium was named, made
the observation that after 30 years (of research by the Lyme cartel) we still know little or nothing.
Dr. Burgdorfer, who is likely the world’s most expert authority in the characteristics of the Lyme
bacterium, believes that late-stage cases of Lyme disease require long-term antibiotics; contrary
to the recommendations of the IDSA guidelines.

The CDC has endorsed the IDSA Lyme guidelines on their public information page. The CDC
has many employees who are also members of IDSA, a private organization. In addition, some of
the authors were former CDC employees and have close ties to the CDC. One question is whether
the CDC should be officially endorsing these guidelines, especially given their controversy. The
CDC itself has massive conflicts of interest with regard to Lyme disease. Much of this was made
possible by the passage of the Bayh-Dole Act in 1980. This allowed intellectual property rights to
be held by those performing research funded by the federal government. As a result, the CDC and
certain of its employees involved in Lyme disease have patent interests in vaccines and Lyme
disease testing methods. The CDC also assigned rights to a Lyme vaccine to SmithKline
Beecham Corporation. Approval by the CDC virtually insures a large market for a vaccine.

The content of the CDC’s Lyme disease information has been diluted to the point that it is of little
benefit to the public and medical practitioners. During vaccine development, the definition of
Lyme disease was altered to one more “vaccine friendly.” The purpose was to limit the disease
definition so as to maximize the apparent efficacy of the vaccine in FDA trials.

In the end, the SmithKline Beecham vaccine turned out to have serious adverse effects, including
death, and was withdrawn from the market. Evidence suggests the CDC knew of these side
effects before the vaccine was approved. A logical conclusion is that the CDC and its employees
are more concerned about protecting their financial health than the public’s health.

The IDSA/CDC’s misinformation and attempts to eliminate ILADS guidelines.

The CDC has standards for Lyme disease testing for surveillance purposes that are highly
restrictive and that very few, even with proven Lyme disease, can meet. The result is that Lyme
disease is vastly underreported, even in areas where it is recognized and where physicians are
more aware. The serologic tests are touted to be highly accurate when, in fact, they are not,
particularly when performed by large high volume laboratories. The CDC does caution that the
strict testing criteria for surveillance purposes should not be used for diagnosis. But they are. The
IDSA guidelines promote the use of the restrictive CDC testing criteria for diagnostic purposes.

While the IDSA guidelines are endorsed by the CDC and touted on the CDC’s Lyme disease
information web page, the alternative ILADS Lyme guidelines are given no mention.

In a closed meeting involving high level CDC employees and the president of IDSA at the time,
Walter Stamm, a directive was approved to eliminate “rogue” Lyme disease guidelines. Although
names were not mentioned in the released minutes of this meeting, this could have only referred
to the alternative patient friendly guidelines issued by ILADS.

Enforcement methods for adherence to IDSA guidelines.

Harassment of competent and credible Lyme disease specialists who treat in accordance with
ILADS guidelines is not uncommon. Investigations are usually conducted by medical boards that
rely on IDSA guidelines and use IDSA “Lyme disease experts” as witnesses. There are a number
of examples of this. In many states, the environment for Lyme specialists is so toxic; patients
must travel to other states for diagnosis and treatment. Some states, such as California, have
adopted legislation to protect legitimate Lyme physicians from harassment.

In essence, the enormous power of IDSA combined with endorsement by the CDC was used to
drive “competitors” out of business and left patients whose insurers relied on the IDSA Lyme
guidelines with no treatment options. This abuse of monopoly powers is one of the factors that
led to the antitrust investigation of IDSA and question the process used to develop its Lyme
guidelines. It was during this investigation that numerous and significant conflicts of interest by
the panel were discovered.

Treatment guidelines, even corrupted ones, are a tool for controlling medicine through the
centralization of medical decision making. Practice guidelines are central to the profitability of
HMO’s and health insurers.

Dr. David Eddy, senior advisor to Kaiser Permanente, stated that “if the fight to control health
care costs is to be successful, it will have to address [the decisions physicians make about
treatments.]” (Eddy DM. Three Battles to Watch in the 1990's. JAMA. 1993; 270(4): 520-26). Dr.
Eddy went on to say “[i]t would not be stretching things too far to say that whoever controls
practice policies controls medicine.” (Eddy DM. Clinical Decision Making: From Theory to
Practice, Practice Policies—What Are They? JAMA. 2000; 263(6): 877–878.).

From an altruistic point of view, ethically and competently derived guidelines could benefit
patients as well as control costs. But when guidelines are driven by interests that are not aligned
with the public interest, as they are when they are exclusionary of divergent opinion and permit
conflicts of interests, they become tools of the pharmaceutical and insurance industries. Thus,
the observations made by Dr. Eddy can have very negative consequences.

The Connecticut Attorney General’s IDSA Lyme guideline antitrust investigation

The Connecticut Attorney General concluded its investigation finding that the IDSA Lyme panel
had substantial conflicts of interest, excluded divergent opinion, and suppressed scientific
evidence. This panel created guidelines that took on the force of law and were treated as
mandatory by insurers, medical boards and courts of law. Laws are generally adopted through
open public debate with input from all affected stakeholders. But the IDSA guidelines panel did
not include community physicians, physicians from the International Lyme and Associated
Diseases Society, and Lyme patients ().

The Connecticut Attorney General forced the IDSA to put together a new panel free from
conflicts of interest to review the guidelines adopted in 2006, permit opposing scientific evidence
to be submitted and considered by the panel, and to have a public hearing with presentations that
will air live over the Internet. Notwithstanding this settlement, it is apparent that the IDSA is
intent on protecting its professional turf at the expense of patient health care. It has made this
clear by stacking the panel with IDSA members and research academics and excluding all
community physicians and members of ILADS. One panel member has been successfully
removed from the panel and another is under scrutiny—both because they had drafted previous
guidelines in contravention of the settlement agreement with the Attorney General. Inclusion of
divergent viewpoints is necessary for treatment guidelines to include options for patients.

The review is still in process.

An independent commentary on the applicability of antitrust law in the development of clinical
practice guidelines is found at http://lyme.kaiserpapers.org/pdfs/lymeantitrust.pdf

My experience

I was a victim of the IDSA/CDC guidelines.

My saga with Lyme disease started on a 1994 road trip to Oregon and California with my dog,
Bo, We were both infected, most likely at a highway rest area. After we returned home, we both
had the distinctive expanding circular rash considered the “hallmark” sign of Lyme disease. Mine
was on my chest and reached about a foot in diameter. I did not know about Lyme disease at the
time and did not realize the significance of the rash. The rash eventually faded and I forgot about
it.

During next the six years I was infected but did not know it, I saw four primary care doctors, two
ophthalmologists, one allergist, and two cardiologists. I saw each of these doctors multiple times
in connection with my Lyme symptoms. This does not include the numerous times I went to ER
during which my resting heart rate was recorded at over 250 beats per minute. An MRI of my
brain showed lesions consistent with neurological Lyme. In a span of about 18 months, I had 11
cardiac catheter procedures to determine the cause and try to correct my cardiac irregularities.

When it was clear that Kaiser could not help, it took me about an hour on the Internet to research
my symptoms and learn the significance of the rash I had. The findings indicated Lyme disease.

Eventually, I saw an infectious diseases doctor at Kaiser. He ordered the cheap and unreliable
ELISA Lyme “screening” test according to the IDSA guidelines. The sample was sent from
Oregon to a contracted lab on the East Coast. The interval between blood draw and analysis was
more than two weeks, which may have rendered the sample worthless because of degradation. (I
later learned that Kaiser has been known to send East Coast samples to labs in the West.) Strain
variations between the East Coast and West Coast can also be a factor in test outcomes.

The result of my test was, of course, negative. The infectious diseases doctor dismissed my rash.
He wrote a two-page report justifying his denial. This was not a casual dictation. It took about
three months for the report to appear in my medical record. In it, he even fabricated information.
One entry read that I believed in Lyme “conspiracists,” something I never said and never brought
up. This was intended to question my mental state.

Later, a Kaiser neurologist tried to help me. He ordered the ELISA and Western Blot tests
through Kaiser and a Western Blot test by an independent lab specializing in tick-borne diseases.
I had to pay for the independent lab test. I did not trust the lab Kaiser used.

He was denied his order to have the Western Blot tests done since the IDSA/CDC/Kaiser protocol
called for a positive ELISA before the more expensive Western Blot tests could be done. Kaiser
again shipped the sample to the East Coast and again my ELISA was negative.

The Western Blot test that was done at the specialty lab came back highly positive with specific
indicators for Lyme. The neurologist wrote another infectious disease doctor that these test results
were not consistent with Kaiser’s negative ELISA test. The infectious diseases doctor replied that
the ELISA is highly accurate (a false IDSA/CDC claim) and I could not possibly have Lyme
disease. In a letter to the chief of infectious diseases, I asked about the significance of the rash I
had. He wrote back while I may have had Lyme disease, I no longer had it. In his opinion, it
cured itself (although I had ongoing symptoms). The positive Western Blot was not in my record.

Finally, I was able to change health plans and see a Lyme specialist in San Francisco. There were
no doctors competent in Lyme disease in my region. My life-threatening heart arrhythmias
resolved within a month of antibiotic treatment (although not all cardiac symptoms resolved). It
took about four years of antibiotic treatment to become functional again.

There was so much damage to my heart that most cardiologists recommended a heart transplant.
This was not an option for me because of the immune suppressing drugs required. Ultimately, a
complicated and expensive open heart surgery was done at Stanford University.

The costs associated with my Lyme disease were in the many hundreds of thousands of dollars.
Medicare paid for the open heart surgery. The cost of the loss of 10 years of my life, during
which time I was unable to work, is incalculable. My companion, Bo, had to be euthanized.

Conclusion and recommendations.

The end result of the IDSA/CDC misinformation about Lyme disease is that most doctors are
incredibly ignorant about Lyme disease believing it is rare or nonexistent in their areas and that
the disease is “hard to catch and easy to cure”. Even using figures that greatly understate the
frequency of the disease, Lyme far outnumbers AIDS in terms of disease frequency. Most doctors
do not question the information provided by the CDC.

The CDC information has never been subjected to peer review as required under the Office of
Management and Budget (OMB) Final Information Quality Bulletin for Peer Review (OMB
Bulletin). Patient advocacy groups have requested a peer review by the CDC and have been
denied. This review should be ordered through a government mandate.

The NIH has conducted studies that are being relied upon to deny patients treatment—yet the data
underlying these studies has not been made available for analysis by others although these studies
have been sharply criticized. A study funded by the NIH that used non-human primates and was
finished more than 6 years ago has never been published. This publicly funded project may yield
vital information on Lyme disease and persistence. This data has not been released and should be
released.

It is difficult to get funding for Lyme disease from non-government sources because there is no
real money in treating the disease, which relies on generic antibiotics. However, Lyme disease
can be a goldmine for pharmaceutical companies that have medications to treat and mask
multiple ongoing symptoms rather than curing the disease itself. In the long run, this approach
can cost far more and the patient does not achieve wellness.

The simple truth is that some government health agencies have operated in a corrupt fashion,
furthering the interests of a handful of researchers, suppressing scientific evidence and
abandoning patients as not even being “on the agenda”. Lyme patients and their physicians
currently have no voice in Lyme disease funding or health care policy matters.

The federal government must step in to correct these injustices. State governments are limited in
what they can do, particularly with regard to federal health agencies. And all or most state
departments of health are dominated by CDC/IDSA information. Inappropriate relationships
between government health agencies and private medical societies, pharmaceutical companies,
and HMO’s should be scrutinized.

For additional information on Lyme disease and some of the corruption involved, I highly
recommend “Cure Unknown: Inside the Lyme Disease Epidemic” by Pamela Weintraub and the
award winning film documentary about Lyme disease, “Under Our Skin.” Also, Lorraine
Johnson, JD, MBA, maintains a blog that discusses the medical-legal-ethical issues surrounding
Lyme disease, that include treatment guidelines, the Connecticut antitrust action against the
IDSA, and the interplay of universal health care at http://tinyurl.com/lymepolicywonk.

A health care reform plan should give careful consideration to the dangers of inappropriately
sponsored and developed clinical practice guidelines and their application in health care reform
issues. The potential misapplication of medical guidelines can result in much greater costs to
government. These include increased disability and government subsidies resulting from patient
abandonment, loss of national productivity due to increased numbers of sick people unable to
work, and the greater costs of long term symptomatic treatment and potentially expensive
medical procedures rather than the treatment of the disease itself.

Elimination of medical corruption is essential to the success of any health care reform plan.
Thank you very much for the opportunity to write this letter.


Sincerely,


Miguel A. Perez-Lizano
Battle Ground, WA
http://lyme.kaiserpapers.org/

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