The Subversion of Medicine Through Treatment Guidelines

The Subversion Of Modern Medicine
Through The Proliferation of
“Treatment Guidelines”

Jerry Leonard

Part Two

Presented At:

The Physician’s
Round Table, 2011

Doubletree Hotel,
Virginia Beach, VA

January 27 - 30, 2011

Preface
• “This year, the group will focus on COMMON
DENOMINATORS that may be keeping patients from
seeing relief.”
• PHYSICIAN’S ROUND TABLE DIRECTOR, Sue Vogan

• This talk will address “political” and economic factors that
are perpetuating epidemics and keeping victims from
getting relief

Goals of Presentation

• To stimulate further investigation into a topic which needs
to be understood by the American public
– The use of “Treatment Guidelines” to prevent effective
treatment
• Manipulation of chronic illness for profit

• To demystify what is going on with respect to chronic
illnesses like Lyme Disease
– Explain the ongoing war against doctors and patients
• How and why it is being waged and by whom, so that
• More effective measures may be employed to fight back

"It is critical that the experts who write clinical
guidelines be prohibited from having any conflicts of
interest.
… they absolutely must be impartial, or it
undermines the whole enterprise."

-- Dr. Marcia Angell, former editor of The New England Journal of Medicine.

The system in which guidelines are drafted is not
impartial, and guidelines have nearly undermined
the whole enterprise.

The trend toward reliance on treatment guidelines
poses a major threat to health freedom, and life
itself.

Treatment Guidelines May Be Fatal

“…following… treatment guidelines for patients with
nosocomial pneumonia appeared to be associated with
an increased mortality risk, researchers reported.”

Rapidly Changing Landscape

• While the increasing reliance on Treatment
Guidelines is being exposed as dangerous,
• News of the flimsy evidence undergirding many
of these guidelines is also being released…

• Conclusions: More than half of the current recommendations of
the IDSA are based on level III evidence (opinion) 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.

“Drug Companies & Doctors:
A Story of Corruption”

“In recent years, drug companies have perfected a new
and highly effective method to expand their markets.
Instead of promoting drugs to treat diseases, they have
begun to promote diseases to fit their drugs.”

--Marcia Angell
• New York Review of Books
• Volume 56, Number 1 · January 15, 2009

Treatment Guidelines are a powerful
tool being used by drug companies to
promote diseases to fit their drugs.

• Background On Treatment Guidelines…

of Treatment Guidelines

“NGC currently 2422 individual summaries.”

In practice,
this is not true!

Treatment Guidelines Gaining Clout

• “Since the 1990s, evidence-based guidelines have had a
pronounced effect on health care,
 influencing not only clinical practice decision-making,
 but also insurers’ coverage of treatments and legal standards of
! care,
 which are applied in malpractice cases and used by state
licensing boards...”

--Richard Wolfram
Connecticut Attorney General Investigation and Settlement
Highlights Possible Applicability of Antitrust Standard Setting
Law to the Development of Clinical Practice Guidelines
» http://lyme.kaiserpapers.org/pdfs/lymeantitrust.pdf

Standard treatment guidelines: Agreed-upon treatment practices for a
diagnosed illness; may include more than details of drug treatment.

“Pharmaceutical manufacturers not only research and develop drugs for the ultimate
goal of treating and preventing disease, but also for high profits.“

World Health Organization Warning

• “Information from pharmaceutical companies should be used
with caution, since such information is biased in favour of
positive results in order to promote sales.

• They may take the form of scientific articles in professional journals,
symposia proceedings, news reports or pamphlets distributed by
drug representatives.”

– Proposal: These various sources of “information” are
also used to justify treatment guidelines “in order to
promote sales” and conduct unethical experiments on
the public.

Treatment Guidelines

• “At the same time that medical guidelines have come to the
fore in health care, there has also been an increasing number
of revelations about financial conflicts of interest on the part of
medical-guideline panelists, whose financial interests may
have influenced their panels to reach incorrect or suspect
results.”

--Richard Wolfram
Connecticut Attorney General Investigation and Settlement
Highlights Possible Applicability of Antitrust Standard Setting

Guidelines and Conflicts

• “A survey of medical experts who write guidelines for
treating conditions like heart disease, depression and
diabetes has found that nearly 9 out of 10 have financial
ties to the pharmaceutical industry, and the ties are
almost never disclosed.”
--Sheryl Gay Stolberg, New York Times

Guidelines and Conflicts

• “The survey, in this week's issue of The Journal of the American
Medical Association, sought the opinions of 192 medical experts
who participated in writing 44 sets of practice guidelines covering
treatment for asthma, coronary artery disease, depression,
diabetes, high cholesterol, pneumonia and other ailments.

• Eleven of the 44 practice guidelines were underwritten by
pharmaceutical companies and carried declarations stating so.
But of the 44 guidelines, just one reported a potential conflict of
interest.”

--SHERYL GAY STOLBERG
“Study Says Clinical Guides Often Hide Ties of Doctors,”
New York Times, February 6, 2002.


• “Guidelines that restrict clinical discretion, …
limit, if not eliminate, choice in the marketplace
for medical treatment.”

--Richard Wolfram
Connecticut Attorney General Investigation and Settlement Highlights
Possible Applicability of Antitrust Standard Setting Law to the
Development of Clinical Practice Guidelines

How To Practice Medicine Without a
License
Pharmaceuticals Companies

Insurance Companies


Doctors

Treatment

Use Of Non-Profit Organizations For Profit

• Non-Profit Groups are used as third-party influence-
laundering agents by pharmaceuticals companies

• Treatment Guidelines are a by-product of this dynamic

• Treatment Guidelines have been used to create a
financial and intellectual cartel

How To Practice Medicine Without a License
3rd-Party Strategy


Insurance Companies
$$$

3rd Party Groups Treatment Guidelines
$$$
Non-Profits

Medical Societies

Medical Education Doctors
& Communications
Companies
(MECCs)
“Treatment”
“Evidence-Based
Medicine”

“My inquiry was spurred, in part by press accounts documenting the
lack of transparency in the relationships between the
pharmaceutical industry and nonprofit organizations.”

Guidelines Are Justified As
“Evidence-Based Medicine”

• Based on selective citation of evidence
• “Evidence” is often subjective and ever-changing
• Definition of “best evidence” is often under the control of
groups who don’t have the patients’ best interest at heart
– Guidelines can prevent choice, even when their authors explicitly
state otherwise

Non-Profits Used For Profit
• Profit-oriented institutions have set up an elaborate network of non-
profit institutions to develop profitable policies (and an
implementation ideology)

• Overview of this network:
– use of corporate think tanks and corporate foundations to control policy
at the national and international level
– Largely from behind-the-scenes

The Strategy
• Pack “advisory boards” with paid lobbyists and propagandists

• Use “third-party” organizations to create “guidelines” which are
claimed to be “evidence-based” and “objective”

• Use “third-party” organizations to promote guidelines and hide the
insider ties and conflicts of interest

• Use media and government influence to enforce guidelines and
punish dissenters (quote “third-party” organizations as credible
experts)

“Information from pharmaceutical companies should be used with
caution, since such information is biased … in order to promote sales.

Drug Marketing Strategy

• The Drug Approval Process
– Riddled with conflicts-of-interest

• Mandating Treatment With Drugs Through
“Treatment Protocols”
– Riddled with conflicts-of-interest

The Drug Approval Process

• Fraudulent Trials
– Selective publicity of successful studies
– Biased interpretation of studies
– Fabricated studies

“…there was a clear and strong link between the orientation of authors’ expressed
views on the rosiglitazone controversy and their financial conflicts of interest with
pharmaceutical companies.”

Selective Publicity In The Approval Process

Government Agencies
Pharmaceuticals
Companies Medical Societies

“Thought Leaders”
Medical Journals
Media Monopoly
“Ivy League” Professors “Experts”
“Medical Education”
$ Study 1 x
Study 3 √ Treatment Guidelines

$ Study 2 x
State Medical Boards

$ Study 3 √ Insurance Companies

$ Study 4 x Doctors Options Limited
Doctors access to information
With negative results not disclosed, researchers and limited
physicians often believe that drugs are more effective and
safer than they actually are, according to Dr. Marcia Angell, a Dissenting doctors and researchers
former editor of The New England Journal of Medicine. ''It put of business (“Sham Peer
changes the way medicine is practiced,'' Dr. Angell said.
Review”, grants denied)

Seizing the Regulatory
Agencies
• ‘… Many of the regulatory personnel come from the industry itself.
The agency is soon captured, one way or another, to benefit the
vested interests in the industry.

• ". . . It is so much easier and, above all, more stable to seize the
legal and administrative apparatus than to fight it, turning
government agencies into licensors of private monopolies and co-
conspirators against the people. . . .”

– Sam Wells, POWER ELITES IN AMERICA: OLIGOPOLY AND
POLITICAL PULL, or BEWARE THE REGULATORY-INDUSTRIAL
COMPLEX

Pharma Advises CDC
• “As numerous medicines have been pulled from the market in recent
years, worries have grown that experts may be recommending medical
products — even ones they know to be unsafe — in part because
manufacturers are paying them.

• As a result, government agencies, medical societies and medical journals
have become increasingly insistent that experts disclose potential conflicts.
And while the experts invariably insist that they have done so, government
audits routinely find large gaps between these disclosures and the experts’
actual income from consulting.

• Congress tightened the rules on outside consulting after similar conflicts
were found among members of advisory panels to the
Food and Drug Administration. But little attention has been paid to the
potential conflicts of advisers to the C.D.C., even though that agency’s
committees have significant influence over what vaccines are sold in the
United States, what tests are performed to detect cancer and how coal
miners are protected.”

– Advisers on Vaccines Often Have Conflicts, Report Says
• GARDINER HARRIS, NYT, Published: December 17, 2009

Pharma Bullies the FDA
• For more than two months in late 2008, private investigators
working for a drug company gathered information on a high-
ranking official at the Food and Drug Administration —
unearthing details about her husband, two daughters and in-laws
and retracing her steps on a business trip she took to Thailand.

• On behalf of the drug company, Kroll also investigated a second
FDA official — Moheb Nasr, director of the FDA’s Office of New
Drug Quality Assessment, creating a file on him that included his
birth date, the price he paid for his home and details of his
education and professional background.

• At one point, the investigators hired a freelance reporter to file
Freedom of Information Act requests, using her status as a
journalist to request Woodcock’s e-mails, phone records, voice
mails, calendars and expense reports, among other documents ...

The Revolving Door:
Pharma and Government

“THE MANNER AND MEANS OF
EXECUTING THE SCHEME”
• The scheme, described below, is referred to herein as the “Fraudulent Marketing Scheme.”

• Marketing Masquerading As Science

• Intense pharmaceutical marketing saturates the pharmaceutical industry and appears in many forms—
some of which some people would call disguised.

• Another key source of drug information for doctors is continuing medical education (“CME”) courses, usually
medical lectures held locally featuring prominent “thought leaders” as speakers. Required to maintain medical
licenses and to stay current with new developments to give patients the best medical care, many CME courses
provide expert syntheses of clinical trial information.

• …Total industry contributions towards continuing medical education is estimated to be seventy percent or higher
and in the hundreds of millions of dollars.

• Pfizer and other drug makers employ recognized clinical experts, well-known and respected in their field and
referred to as “thought leaders” or “key opinion leaders,” to join company “speakers bureaus” and conduct CMEs
and product promotional programs in exchange for often significant lecture fees.

• One recent study indicates that at least twenty-five percent of all doctors in the United States (approximately
200,000 physicians) receive drug money for lecturing to physicians or for helping to market the drugs in other
ways.

• In many of these presentations, the slides used have been “created by drug makers, not the speakers. That’s
like ghost-talking.” (Gardiner Harris, Group Urges Ban on Medical Giveaways, N.Y. Times, April 28, 2008.)

“… a sophisticated and fraudulent
marketing scheme”

• ‘J&J’s Janssen Pharmaceutica funneled kickbacks to Texas health
officials, distributed false marketing materials and deployed phony
advocacy groups to get its Risperdal antipsychotic prescribed to
low-income Texans, the state alleges in a new filing in an ongoing
fraud lawsuit filed in 2006, according to The Dallas Morning News.
• The records in the civil suit allege Janssen defrauded the state
repeatedly over the last decade to secure a spot for Risperdal on
“J&J’s Janssen
the state’s Medicaid preferred drug list and on Pharmaceutica deployed
controversial
medical protocols that determine which drugs are given to adults
phony advocacy
and children in state custody, the paper writes.groups to get its
• Texas has spent millions of state Medicaid dollars on the drug,
Risperdal antipsychotic
which some recent studies show performs no better thanto low-income
prescribed cheap
generics, and can lead to diabetes and excessive weight gain,
Texans… “
particularly in children.
• Janssen officials “targeted Texas Medicaid with their sophisticated
and fraudulent marketing scheme,” the attorney general’s office
writes in the filing (here it is).’

Kickbacks and Treatment
Protocols

Kickbacks and Treatment
Protocols

• Patrick Burns, a spokesman for Taxpayers
Against Fraud:

– "In the pharmaceutical industry, the business
isn't selling the best drug, it's the best scheme of
kickbacks to the prescriber. Omnicare is just one
of their sales points."

Marketing Drugs Through “Thought
Leaders” On-The-Take
• “Since drug companies don't have direct access to human subjects, they need to
outsource their clinical trials to medical schools … mainly because it gives them
access to highly influential faculty physicians—referred to by the industry as
"thought-leaders" or "key opinion leaders" (KOLs).

• These are the people who write textbooks and medical journal papers, issue
practice guidelines (treatment recommendations), sit on FDA and other
governmental advisory panels, head professional societies, and speak at the
innumerable meetings and dinners that take place every year to teach clinicians
about prescription drugs.”

The Tobacco Scientists Reborn
• "... For 50 years, cigarette manufacturers employed a stable of scientists
willing to assert (sometimes under oath) that there was no conclusive
evidence that cigarettes cause lung cancer, or that nicotine is addictive.
• …Toward that end, the tobacco manufacturers dissected every study,
highlighted every question, magnified every flaw, cast every possible doubt
every possible time.
• They also conjured their own studies with questionable data and foregone
conclusions. It was all a charade, of course, because the real science was
inexorable. But the uncertainty campaign was effective; it delayed public
health protections, and compensation for tobacco's victims, for decades.

• The tobacco industry, left without a stitch of credibility or public esteem, has
finally abandoned that strategy -- but it led the way for others..."

--David Michaels, a former Assistant Secretary of Energy and professor at
George Washington University School of Public Health (The Art of 'Manufacturing
Uncertainty‘)


The Cartel Government Agencies
Pharmaceuticals
Companies Media Monopoly

“Thought Leaders”
Medical Journals
Medical Societies
“Ivy League” Professors “Experts”
“Medical Education”
$ Study 1 x
Study 3 √ Treatment Guidelines

$ Study 2 x
State Medical Boards

$ Study 3 √ Insurance Companies

$ Study 4 x Doctors Options Limited
Doctors access to information limited
Dissenting doctors and researchers
put of business (“Sham Peer Review”,
grants denied)

• The Result: A Drug Saturated Society…

“According to the survey, 48 percent of all adult Americans reported
taking at least one prescription medication in the last year, a jump
from 44 percent one decade ago. The increase also held true from
youths and seniors, whose usage rose to 20 percent and 90 percent,
respectively.

CDC statistician Dr. Charles F. Dillon says that the most significant
increase is that of the elderly. Within that group, nearly 40 percent of
all patients require five or more prescription drugs.”

Dillon says he and his team thought the increase in senior drug use
"was just incredible“…

“The analysis also found that 20 percent of children and 90 percent
of adults 60 and older reported using at least one prescription drug
in the past month, said the U.S. Centers for Disease Control and
Prevention researchers.”
Among adults 60 and older, more than 76 percent used two or
more prescription drugs and 37 percent used five or more.

According to Jon Rappoport

• “Each year in the US there are:

– 12,000 deaths from unnecessary surgeries;
– 7,000 deaths from medication errors in hospitals;
– 20,000 deaths from other errors in hospitals;
– 80,000 deaths from infections acquired in hospitals;
– 106,000 deaths from FDA-approved correctly prescribed
medicines.
– The total of medically-caused deaths in the US every year is
225,000.

• The medical system [is] the third leading cause of death
in America, behind heart disease and cancer.”

Summary of Profits
• ‘In 2002, the total earnings of the ten largest pharmaceutical companies
exceeded the combined earnings of the other 490 companies listed in
Fortune’s top 500 most profitable companies: the ten largest
pharmaceuticals together made a total profit of 35.9 billion dollars and the
other 490 companies together made a total profit of 33.7 billion dollars27.

• The disproportionate privileges that the pharmaceutical industry is enjoying
in the form of tax breaks and advantageous laws and agreements, show
clearly that the industry’s current power and wealth are not the result of a
“free market” but rather of a deliberate policy designed to protect an industry
that is as politically strategic to the USA as the petroleum industry.

• … Marcia Angell, chief editor of the renowned medical review The New
England Journal of Medicine for almost twenty years, succinctly affirms:

• “The colossus that is the pharmaceutical industry is today like a five-
hundred pound gorilla: it can do what it wants.”’

According to Dr. Mercola

• “According to a new database created by ProPublica,
seven drug companies paid $282 million to more than
17,000 doctors during 2009-2010.
• In 2006, the pharmaceutical industry spent an
estimated $16 BILLION on physician advertising. At
the time, that amounted to $10,000 for every doctor in
the US.”

Teresa Forcades is a controversial
Benedictine nun …

Summary of Crimes

• “In the brief period from 2000 to 2003, almost all the large
pharmaceutical companies went before state tribunals in the USA,
accused of fraudulent practices. Eight of these firms were fined over
2.2 billion dollars.

• Four of these eight companies — TAP Pharmaceuticals, Abbott,
AstraZeneca and Bayer — admitted criminal responsibility for
activities that put the lives and health of thousands of people at
risk.”

According to Dr. Mercola
• “Prescription drugs are responsible for an estimated
700,000 ER visits a year due to adverse drug reactions.

• And adverse drug reactions from drugs that are properly
prescribed and properly administered cause about
106,000 deaths per year, making prescription drugs the
fourth-leading cause of death in the U.S.”

• The truth is prescription drugs kill more than twice as
many Americans as HIV/AIDS or suicide. Fewer die from
accidents or diabetes than adverse drug reactions.”

‘But what if wrong answers aren't the exception but the rule?

More and more scholars who scrutinize health research are now making
that claim. It isn't just an individual study here and there that's flawed,
they charge.

Instead, the very framework of medical investigation may be off-kilter,
leading time and again to findings that are at best unproved and at worst
dangerously wrong. The result is a system that leads patients and
physicians astray--spurring often costly regimens that won't help and
may even harm you.

Corruption and Public Harm In Drug Approval &
Marketing Process…

Leads To …

Corruption and Public Harm Through The
“Treatment Guideline” Process

= Preventing Doctors From Administering Drugs for
Patients

Institutionalizing Pharma Crimes
• Documented crimes in the drug approval process:
– Rigged drug approval system, Complete lack of accountability:

• selective publication of favorable information,
• outright fraudulent studies,
• rigged trials to discredit competing treatments,
• 3rd party non-profit/pharma arrangements,
• pharma funding & intimidating the FDA,
• Congress owning pharma stock,
• thought-leaders on-the-take,
• bribery of doctors,
• physician intimidation and prescription tracking,

• Leads to corrupt process for enforcing medicating public
– Formulation of “treatment guidelines” which can mandate the application of pharmaceuticals
(another form of physician intimidation) by preventing the physician from treating root-cause

– Punishment for straying from “treatment guidelines” (“evidence-based medicine”, “best-
practices”)

• Creation of an artificial/mandated increase in pharmaceuticals profits

• Conflicts of interest in drug approval process
leads to
– Conflict of interest in treatment guidelines
– Emphasis on symptom treatments, not underlying
cause
– Profits for pharmaceuticals industry

• Doctors or regulators who fight the system
are targeted and destroyed.

‘AN international drug company
made a hit list of doctors who had to
be "neutralised" or discredited
because they criticised the anti-
arthritis drug the pharmaceutical
giant produced.’

“Drug Companies & Doctors:
A Story of Corruption”

In recent years, drug companies have perfected a new
and highly effective method to expand their markets.
Instead of promoting drugs to treat diseases, they have
begun to promote diseases to fit their drugs.

--Marcia Angell
• New York Review of Books
• Volume 56, Number 1 · January 15, 2009

• “…they have begun to promote diseases to fit
their drugs.”

– Treatment guidelines are being used by drug companies
to promote diseases to fit their drugs.

– Treatment guidelines are based largely on the opinion of
manufactured experts.

“However, guidelines are not just
summaries of the evidence. They are
also interpretations of that evidence by
guideline authors …”

• Conclusions: More than half of the current recommendations of
the IDSA are based on level III evidence (opinion) 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.

The Addiction To Drug Companies
• “The overall influence of the industry is to emphasize drug
treatment at the expense of other modalities: psychotherapy, social
approaches, nutritional, herbal, and natural remedies, rehabilitation,
general hygienic measures, non-patentable drugs, or other
alternative approaches.

• It focuses attention on disorders that are treatable by drugs,
and may promote over diagnosis. It reinforces the practice of
dealing with disease by treatment of symptoms, and diverts
interest from prevention.”

• Wortis, J., and Stone, A. The addiction to drug companies. Biol. Psychiatry
32:847-849, 1992


Insurance Companies
$$$

3rd Party Groups Treatment Guidelines $$$
Non-Profits “At the same time that medical guidelines
have come to the fore in health care, there
has also been an increasing number of
Medical Societies revelations about financial conflicts of
interest on the part of medical-guideline
panelists, whose financial interests may have
influenced their panels to reach incorrect or
Medical Education Doctors suspect results.”
& Communications --Richard Wolfram
Companies
(MECCs)
Treatment

“Guidelines … restrict clinical discretion… limit, if not eliminate,
choice in the marketplace for medical treatment.” --Richard Wolfram

Insurance Companies Benefit, Too

Insurance-Friendly Treatment
Guidelines
• The disease can be devastating, both physically and
financially. “The insurance has been a nightmare,” she
said. Even though Motwani has insurance, she can’t get
covered for her drugs.

• But she said each time she submits a claim, Blue
Shield comes back with some reason why they can’t
cover it.

Insurance Friendly Treatment
Guidelines
• Motwani is not alone. “There is an insurance problem,” said Dr.
Christine Green, Mona’s specialist. Green said many advanced
stage Lyme disease patients go through the same ordeal.

• It has to do with the standard of care for Lyme set by the
Infectious Disease Society of America and upheld by the
Centers for Disease Control.

• “If you look at the IDSA standard of care, that patient needs a month
of antibiotics,” Green said.

• For advanced stage Lyme disease, it’s just not enough. “The
insurance companies as near as I can see have chosen the
least expensive standard of care,” Green said.

Application
• Given the state of pharma corruption of the medical system (and
medical literature)…
• If you had a poorly understood disease
– Complex infectious agent
• Pleomorphic, stealth pathogen
• Difficult to culture
• Tests for which are ambiguous
– Symptoms are non-specific, but plentiful and chronic

• It would be relatively easy for industry-funded “thought-leaders” to
create “treatment guidelines” for the disease, which allowed the
infectious agent to go largely untouched, so that the symptoms
could be profitably treated, in perpetuity (while insurance claims are
denied).

Application
• This is the case with Lyme Disease
• The 3rd-Party group peddling destructive
treatment guidelines is the IDSA
– Authors have numerous ties to insurance and
pharmaceuticals companies (and the CDC)

Conflicts Summary
• A recent journal article entitled “A Critical Appraisal of ‘Chronic’ Lyme Disease,”[i] reveals how
members of the so-called "Steere Camp"[ii] of Lyme disease research continue to perpetuate
misinformation to further a profit-oriented agenda.
• This agenda consists of commercializing Lyme disease under the pretext of treating it.
• It is implemented by a handful of well-connected academic researchers who have created a
fraudulent science base to allow the Lyme epidemic to quietly spiral out of control.[iii]
• This has been accomplished by
– denying the persistent, pervasive and pleomorphic nature of the extraordinarily complex borrelia organism
that causes Lyme disease.
– denying the plurality of devastating manifestations that often result from the deliberately ineffective
treatment regimens recommended by the “Steere Camp” doctors.
• Careful investigation reveals that the “Steere Camp” authors have numerous financial
connections to industries that profit from allowing the causative agent of Lyme disease to
propagate untreated.
• A case is made that the positions adopted and enforced by members of the “Steere Camp” reflect
this incestuous financial relationship on a point-by-point basis rather than their self-proclaimed
interest in offering effective treatments to the public, which is actually suffering greatly from
Steere-Camp policies.
– It is the Steere Camp’s numerous connections to symptom-proliferation interests that defines its ideology,
rather than an interest in eliminating the disease at its source.
– This is why the Steere Camp is so at odds with the component of the scientific community concerned with
symptom-elimination. The symptom-elimination professionals are a threat to the profits of the symptom-
proliferation industries that hire and publish the “research” of the “Steere Camp” authors.

Conflicts Summary
• Let’s examine the paragraph describing the conflicts-of-interest of the authors of the Journal
article that will serve as a rationale for not treating “chronic Lyme disease” by claiming that it
doesn’t exist.[i] The paragraph states:

• "Dr. Feder reports receiving lecture fees from Merck and serving as an expert witness in medical-
malpractice cases related to Lyme disease.
• Dr. Johnson reports holding patents on diagnostic antigens for Lyme disease.
• Dr. O'Connell reports serving as an expert witness related to Lyme disease issues in civil and
criminal cases in England.
• Dr. Shapiro reports serving as an expert witness in medical-malpractice cases related to Lyme
disease, reviewing claims of disability related to Lyme disease for Metropolitan Life Insurance
Company, and receiving speaker's fees from Merck and Sanofi-Aventis.
• Dr. Steere reports receiving a research grant from Viramed and fees from Novartis.
• Dr. Wormser reports receiving research grants related to Lyme disease from Immunetics, Bio-
Rad, and Biopeptides and education grants from Merck and AstraZeneca to New York Medical
College for visiting lecturers for infectious-disease grand rounds, being part owner of Diaspex (a
company that is now inactive with no products or services), owning equity in Abbott, serving as
an expert witness in a medical-malpractice case, and being retained in other medical-malpractice
cases involving Lyme disease. He may become a consultant to Biopeptides. No other potential
conflict of interest relevant to this article was reported."[ii] [emphasis added]

Conflicts Summary
• Specifically, the conflict-of-interest paragraph above reveals that
various authors of the article:
– are paid as consultants by insurance companies that have a financial
interest in Lyme disease not being effectively treated with expensive,
long-term therapies[i]
– are paid by pharmaceuticals companies that have a financial interest in
Lyme disease not being effectively treated, because the myriad
symptoms caused by chronic Lyme disease represent multiple, billion
dollar markets[ii]
– are paid by pharmaceuticals companies which have a financial interest
in an expanding market for Lyme disease vaccines, which is abetted in
numerous ways if Lyme disease goes untreated
– have vested patent interests in certain test organisms and procedures
for Lyme disease diagnosis being established as future standards
– also conveniently serve as "expert" witnesses in orchestrated
"malpractice" suits brought by state medical boards against highly
experienced doctors who attempt to eliminate the disease at its source
to improve the lives of their patients[iii]
•

Overview of Lyme Epidemic
• This ambitious marketing effort is assisted by drug company
consultants publishing as “independent scientists” in journals such
as the NEJM. The goal of these crypto-lobbyists is to generate an
artificial demand for pharmaceuticals products. This is accomplished
through:
– creating a man-made epidemic by printing misinformation about the
contagious nature of a deadly disease
– perpetuating the epidemic while appearing to treat it with deliberately
ineffective treatment guidelines
– creating a fraudulent science-base as an intellectual justification for
perpetuating the ineffective treatment guidelines, which also aids in
• limiting the supply of doctors capable of administering effective treatments to halt
the epidemic; and correspondingly,
• emphasizing the profitable treatment of symptoms over curing the disease at its
source

Lyme Bacterium: Complexity
• “The spirochete, a corkscrew-shaped bacterium, is
unique in the known bacterial realm because of the
quantity of DNA it carries that enables it to evade
detection and attack the human immune system.
• It can change its outer protein coat, cloaking itself
from immune detection. It also can completely
change form, becoming a treatment-resistant cyst,
or shed its outer coat to enter our own cells to set up
shop.”

• “Living with Lyme: Bacterium can 'cloak' itself”
– By Dr. Jon Sterngold/Special for The Willits News (9/30/2009)

Lyme Infection Summary
Symptom Generator

“Lyme disease is a multisystem disorder with
protean manifestations.....”

Benjamin J. Luft, ......Raymond J. Dattwyler, “Invasion of the Central
Nervous System by Borrelia burgdorferi in Acute Disseminated
Infection,” JAMA; 1992; 267:1364-1367.

Lyme Infection Summary
Symptom Generator

“Human infection can result in neurologic,
cardiovascular, or musculoskeletal
disorders.”

The New Great Imitator
• “Because of the difficulty in culturing Borrelia bacteria in the laboratory, diagnosis
of Lyme disease is typically based on the clinical exam findings… Serological
testing … is not diagnostic by itself.

• The most widely used tests are serologies, which measure levels of specific
antibodies in a patient's blood. These tests may be negative in early infection, as the
body may not have produced a significant quantity of antibodies...

• The reliability of testing in diagnosis remains controversial…

• Diagnosis of late-stage Lyme disease is often complicated by a multi-faceted
appearance and non-specific symptoms, prompting one reviewer to call Lyme the
new "great imitator."

• Lyme disease may be misdiagnosed as multiple sclerosis, rheumatoid arthritis,
fibromyalgia, chronic fatigue syndrome (CFS), lupus, Crohn's disease or other
autoimmune and neurodegenerative diseases.”

• Not to mention depression…

Rx For Disaster (For Patients)
• Poor tests, many non-specific symptoms,
difficult diagnosis …

Rx For Profits (For Pharma)
• Poor tests, many non-specific symptoms,
difficult diagnosis …

(And Make Lots of Money)

“One way drug companies have marketed their products
is by funding the implementation of guidelines…”
--Civil Action No. 08 CA 11318 DPW

Symptom-Oriented

Doctors Doctors Doctors

Treatment I Treatment II Treatment III

Symptom A Symptom B Diseased Patients Symptom C Symptom D

Proposed Model For Treatment Denial
$$$ Pharmaceuticals Companies $$$

Insurance Companies
“Cartel”
NIH, FDA, CDC, EIS State Medical Boards

Intellectual Cartel Information Cartel
Ivy League Professors Symptom-Oriented Medical Journals
“Consigliere”

Medical Societies Mass Media
Continuing Education





$$$ Pharmaceuticals Companies $$$

Insurance Companies
“Lyme
Cartel” NIH, FDA, CDC, EIS State Medical Boards

Intellectual Cartel Information Cartel
Ivy League Professors Symptom-Oriented Medical Journals
“Consigliere”
Medical Societies Mass Media




The IDSA Guidelines & Lyme
Disease: Effects
• “… the guidelines effectively deny physicians the ability
to use clinical discretion in diagnosing and treating Lyme
disease, despite the IDSA’s general disclaimer that its
guidelines are not mandatory.

• The guidelines also provide no additional treatment
options, apart from palliative care, for patients who fail
to improve under treatments identified by the IDSA’s
protocol.”
– Richard Wolfram
• Connecticut Attorney General Investigation and Settlement
Highlights Possible Applicability of Antitrust Standard Setting Law to
the Development of Clinical Practice Guidelines

• A manufactured epidemic through the
enforcement treatment guidelines…

‘We're in the midst of a
terrifying epidemic,
although you wouldn't
know it to talk to most
doctors and health
specialists.

The disease is growing
at a rate faster than
AIDS. From 2006 to
2008 alone, the number
of cases jumped a
whopping 77 percent. …
If any other disease had
stricken so many people,
the medical community
would be scurrying for
knowledge, scrambling
for cures or rushing to
warn patients.

But that's not the case
with Lyme disease -- a
disease carried by ticks.‘

Lyme Statistics
• Reported cases of Lyme disease doubled from 1991 to 2007. In
2007, the CDC noted that
– “Since Lyme disease became nationally notifiable in 1991, the annual
number of reported cases has more than doubled.”

• In 2007, the Boston Globe reported a similar doubling of Lyme
cases in Massachusetts in one year:
– “The number of Lyme disease cases reported in Massachusetts jumped
by about 50 percent from 2004 to 2005, a single-year increase that
prompted concerned state health officials to say they were stepping up
efforts to educate the public about prevention of the disease.”
• Felicia Mello, “Lyme cases in Mass. go up 50% in one year,” Boston Globe,
June 15, 2007.

“Only a very small number
of physicians in Connecticut
-- the epicenter of Lyme
disease -- diagnose and
treat patients with the
controversial chronic form
of this tick-borne infection, a
survey found.

Among 285 primary care
physicians surveyed, only
about 2% treat chronic
Lyme disease…”

Denying Care Through “Treatment Guidelines”

• Lyme Disease patients are being denied long-term antibiotics, under various pretexts,
by a very well-connected minority of academics with ties to the CDC (and the
biowarfare-related research agencies)
– IDSA Treatment Guidelines written by this group of academics (allegedly voluntary) are
inappropriately used by insurance companies to deny treatment for patients (Non-Treatment
under the pretext of treatment.) and to go after doctors who treat against the arbitrary
“standard of care” they have dictated

• One pretext is that antibiotics have dangerous side-effects, which preclude prolonged
use:
– "You're not going to withhold treatment for a potential side effect, which may never occur,
and ignore a known infection that desperately needs to be treated.“ --Dr. Joseph Burrascano

• Another is that long-term antibiotic treatments create drug-resistant strains of
diseases
– By not treating the Lyme disease infection to completion the “experts” are, in fact, creating
drug-resistant strains of Lyme disease, under the pretext of preventing them.

IDSA Guidelines: Effects
• "Physicians who have cared for persons with chronic Lyme disease
have faced harassment at a minimum and for some, their
careers have been ruined.

• Researchers who have seriously dedicated themselves to the
scientific study of chronic Lyme disease in humans and/or animals
have often found themselves attacked or marginalized.

• To persist in their researches would have resulted in virtual
career suicide and some have been forced, by exigencies of
survival, to leave the field."

--Kenneth B. Liegner, M.D.

• Upward of 30 doctors, most of them in the
Lyme-riddled northeastern states, have been
similarly sanctioned in the past decade.

• “A lot of physicians in our state are hesitant to
get involved because of the medical debate
that’s raging about this disease,” says Monte
Skall, president of the National Capital Lyme and
Tick-Borne Disease Association.’

• “The doctor of last resort,” Beth Macy, The
Roanoke Times

• ‘Among the establishment’s latest strategies, according to … Monte Skall:
Pick a so-called “Lyme-literate” doctor, go after his or her records and create
a chilling effect on other doctors who dare treat outside the IDSA
guidelines, considered the gold standard of care.

• “If you want to go into [treating Lyme], you have to go into it knowing
there’s a good chance that sooner or later somebody will file some kind
of a complaint,” Dr. Geoffrey Gubb says.

• “What’s difficult is to feel that I’m endangered when all I’m doing is the
best I know how to do.” Dr. Cathryn Harbor’

• “The doctor of last resort,” Beth Macy, The Roanoke Times

CDC Mandates Non-Treatment

• The CDC maintains that its Lyme protocol is not a mandate for clinicians.
Echoing the IDSA guidelines, it recommends limiting antibiotic treatment
with an eight-week ceiling but holds that the vast majority of Lyme cases are
easily treated in two to four weeks.

• Its case definition for Lyme is supposed to be used to confirm the spread of
Lyme and then alert the public as necessary. But most doctors view the
guidelines as “black and white and incontrovertible,” Monte Skall says.”

• “The doctor of last resort,” Beth Macy, The Roanoke
Times

CDC Mandates Non-Treatment

• ‘Most Western Virginia physicians side with CDC guidelines where chronic
Lyme disease is concerned.

• Dr. Jody Hershey, New River Health District director, says that doctors who
follow the CDC’s narrow definition of Lyme fail to diagnose some patients
with the disease.

• In another case, a Lyme-positive veterinarian he’d already treated for 12
weeks returned for further treatment. But [Dr.] Chaudry refused, saying his
hands were tied:
– “Our practice is restricted by higher authorities, like the CDC.”’

• “The doctor of last resort,” Beth Macy, The Roanoke
Times

Doctor Persecution
• In 2001, the New York Times reported that in
• “…a final attempt to control standards of treatment and rein in the
Lyme lobby, state medical boards have started to investigate
doctors across the country for prescribing months and even years of
antibiotics.”
» NYT, Stalking Dr. Steere

• The New York Times paraphrased Dr. Joseph
Burrascano (a doctor who was persecuted for speaking
the truth about Lyme disease “experts” to congress) as
follows
• “They were trying to resolve a medical dispute that had raged for
years by simply annihilating doctors on the other side.”

Lyme Doctors Singled Out
Dr. Charles Jones
• ‘Last week the Connecticut Medical Examining Board (CMEB) voted
to discipline Dr. Charles Ray Jones, the 80-year-old pediatrician
featured in UNDER OUR SKIN, for technical violations in the way he
diagnosed and treated three children suspected of having tick-borne
diseases.

• …Last year the medical board punished 43 physicians for
serious charges such as substance abuse, sexual misconduct,
mental illness, and negligence; not one of these physicians received
a fine larger than $5,000. And only one other physician, accused
of drug abuse, received a longer supervised probation period
than Dr. Jones – though this drug-addict doctor did not receive
the additional $20,000 in fines levied on Dr. Jones.

• None of Dr. Jones’ treatments resulted in patient harm and his
medical decisions were motivated by his desire to begin the
treatment of these very sick children as soon as possible.

Dr. Charles Jones
• ‘Irrespective of whether the punishment fits the “crime,” the medical
board’s six-year investigation into Dr. Jones has sent a headline-
grabbing message to every pediatrician in Connecticut –
– If you treat children with Lyme disease with more than four weeks of
antibiotics, you may lose your medical license and be treated as a
pariah among your peers.

• So, with
Connecticut Lyme cases skyrocketing up 118% from 2006 to 2008,
and the state desperately needing every Lyme specialist it can get,
the children of Connecticut are the ones receiving a potential life
sentence of suffering, if they acquire one or more tick-borne
diseases.’

Dr. Joseph Jemsek

 “Over the last decade, a national debate has
erupted concerning the treatment of Lyme disease.
Patients that have suffered for years contend that
treatment using the IDSA guidelines is not
effective. They've opted, instead, to seek long-term
treatment from doctors like Jemsek.

 Last summer, the N.C. Medical Board
disciplined Jemsek for his treatment of Lyme
disease, ruling that his use of long-term IV antibiotics
fell outside the prevailing standard of care.
Additionally, while consent was obtained from every
patient Jemsek treated, the board ruled that he had
failed to adequately inform patients that his treatment
differed from the norm.”

Specialist Fights Insurance Company

... For some patients, then, the ambiguities
surrounding diagnosis and treatment and the
consequent sense of abandonment by
medical professionals were among the most
distressing aspects of the illness experience.”

Lyme Patients Singled Out
“Patients infected with many other kinds of common bacteria—such
as those that cause tuberculosis, bronchitis, or UTIs—can
experience relapses after an initial course of antibiotic treatment
fails or proves inadequate. Doctors routinely retreat patients who
relapse in order to achieve a cure and prevent chronic symptoms.

Why should patients with Lyme disease be treated differently?”

– Daniel J. Cameron, Proof That Chronic Lyme Disease Exists
• Interdisciplinary Perspectives on Infectious Diseases
Volume 2010 (2010), Article ID 876450, 4 pages
doi:10.1155/2010/876450 Research Article

Lyme Doctors Singled Out
• “…Last year the medical board punished 43 physicians for serious
charges such as substance abuse, sexual misconduct, mental
illness, and negligence; not one of these physicians received a fine
larger than $5,000. And only one other physician, accused of drug
abuse, received a longer supervised probation period than Dr.
Jones – though this drug-addict doctor did not receive the additional
$20,000 in fines levied on Dr. Jones.

• None of Dr. Jones’ treatments resulted in patient harm and his
medical decisions were motivated by his desire to begin the
treatment of these very sick children as soon as possible.”

• "It's insanity. We're begging our own state's Medical
Board to allow Kalyn to get healthy."
• Denise Faggart, Mother of Kalyn Faggart, watching her daughter go
blind due to NC Medical Board's war on Jemsek, preventing
successful treatment

• "We've looked for other doctors, but nobody will deal with
it here because they're terrified by what happened to Dr.
Jemsek. All we want is for our son to be able to be home
and get well. Dr. Jemsek did that for us. He gave us
back our son's life."
• Katie Jacks, mother of son whose health is failing because of NC
Board's halting of treatment for Lyme Disease by Dr. Jemsek,
Rhinoceros Times Charlotte, Feb. 8, 2007

Systematic Denial of Care
• Karen Forschner’s tragic case indicates the degree to which Lyme
disease patients are treated in the medical community.

– Forschner attempted to get treatment for her child, who she believed got
Lyme disease after she was bitten by a tick while pregnant and
subsequently suffered a crippling bout of arthritis.
– Forschner related how her child was subsequently denied antibiotics by
her pediatrician who refused to give her amoxicillan for a condition that
was clearly improved by antibiotics, claiming the medication was
dangerous.
– A few weeks later, she went to the same pediatrician to treat her child
for an ear infection that hadn’t even started and was given the same
“unsafe” antibiotic (at the same dose and over a long-term period)
without hesitation.

• This case illustrates the medical ignorance displayed by uninformed doctors
on the contagious nature of the disease (including congenital cases) and the
benefits of long term antibiotics in keeping the disease at bay:

– “But despite the dramatic and documented improvements, over the years, local
doctors and health officials would repeatedly interfere with our son’s re-treatment
—as [the doctors believed] Lyme was easily curable.”

• After Forschner’s son died of Lyme disease complications she formed the
Lyme Disease Foundation, one of the most powerful grassroots
organizations lobbying on behalf of Lyme victims.

• Apparently, the “unsafe” drugs were perfectly safe when not being
administered for Lyme disease. As Forschner summarized:

– “Despite the proven cause and effect of treatment, evaluated by many
independent professionals the label of “Lyme disease” caused a paranoid
behavior to withhold life-saving treatment.” [ii]

• This case illustrates the medical ignorance displayed by uninformed doctors
on the contagious nature of the disease (congenital cases) and the benefits
of long term antibiotics in keeping the disease at bay:

– “But despite the dramatic and documented improvements, over the years, local
doctors and health officials would repeatedly interfere with our son’s re-treatment
—as [the doctors believed] Lyme was easily curable.”

• After Forschner’s son died of Lyme disease complications she formed the
Lyme Disease Foundation, one of the most powerful grassroots
organizations lobbying on behalf of Lyme victims.

“Never would I have deemed it possible that a group of
medical people would work so vigorously and with such
malice against a group of desperately ill people. But,
here it is.”

–Lyme victim/activist (requested anonymity)

So now we have… a pandemic fueled by political
motives coupled with a consummate disregard for public
health, and a pandemic which, when the sources,
motives, and actions that led to the … pandemic come to
light, will be incomprehensible in its amorality and
foolishness.

--Anonymous, MD

Systematic Denial Of Care

“It is difficult enough for someone suffering debilitating symptoms due
to late-stage Lyme disease to get well with the judicious, but adequate,
use of long-term antibiotics. Almost no one gets better without these.

To deny patients access [to] this care is a travesty. But this happens
all the time and patients often travel hundreds to thousands of miles to
see one of the small numbers of Lyme experts in this country.

How can that be?”

--Jon Sterngold, MD

How Is This Being Done?
• Control over treatment is dominated by giant
corporations with a vested interest in not treating the
underlying disease
– Pharmaceuticals & insurance companies

• They are in fact practicing medicine without a license
through 3rd-party “information laundering”
– Using private medical societies like the IDSA
– Funding “Thought Leaders” (Tobacco Scientists) to create a
“business-friendly” fraudulent science base for treatment denial
• To define the disease and its treatment in a commercialized,
symptom-treatment version of the disease,
• Rather than a patient-centered version that treats the underlying
cause

Detailed Model For Treatment Denial

Analyzing The Forces At Work
• In which direction will an
object move?
– What forces are acting on the
object?
– Which forces have the largest
net magnitude?
– The object will move in that
direction.
– “Free body diagram”

Analyzing The Forces At Work In
Lyme Disease Politics

• Why aren’t patients being treated?
– What forces are at work?
– What is their source of power?
– Which forces have the largest net magnitude?

Mandating Markets Through Treatment Guidelines
Symptom Treatments, Vaccines Reduced Payout = Increased Profits

Pharmaceuticals Insurance Profit from treatment of
Companies Companies symptoms, not treatment of
underlying infection “Voluntary
Consulting Treatment
$ Consulting
Fees Guidelines”
Fees
Government Medical Mass Medical
Cartel
Agencies Journals Media Societies
“Voluntary
Grants Guidelines”
Enforcement

Ivy League Thought- State Medical
Doctors Leaders Boards
“Expert” Tobacco
Witnesses Scientists

Doctors
“One way drug companies have Disease Mythology “Voluntary
marketed their products is by funding vs
Guidelines”
Enforcement
the implementation of guidelines…”
--Civil Action No. 08 CA 11318 DPW Disease Reality Untreated
Patients

Mandating Markets Through Treatment Guidelines
Symptom Treatments, Vaccines Reduced Payout = Increased Profits

Pharmaceuticals Insurance Profit from treatment of
Companies Companies symptoms, not treatment of
underlying infection “Voluntary
Treatment
$ Guidelines”

Government Medical Mass Medical
Cartel
Agencies Journals Media Societies
“Voluntary
Grants Patent Owners Guidelines”
Business Owners Enforcement

Ivy League Thought- State Medical
Doctors Leaders Boards
“Expert” Tobacco
Witnesses Scientists

Doctors
“One way drug companies have Disease Mythology “Voluntary
marketed their products is by funding vs
Guidelines”
Enforcement
the implementation of guidelines…”
--Civil Action No. 08 CA 11318 DPW Disease Reality Untreated
Patients

What’s Really Going On?

• An epidemic of:
– Misinformation
– Misdiagnosis
– Misery
• for patients and doctors

• Yet the same CDC “experts” who have
been wrong from the beginning, are still
running the show and calling the shots.

Eliminating Competition for the “Lyme
Cartel”

• Limiting Supply:
– Creating treatment guidelines through fraudulent
studies
– Discrediting of competing treatments

• Increasing Demand: Creating diseases through
ineffective treatment guidelines
– Non-treatment of root infection
– Treatments of symptoms
– Creation other symptoms
– Promotion of vaccines

Pharmaceuticals Insurance Profit from non-treatment of
Companies Companies underlying infection

Government Medical Medical Technical and
Dream World ideological enablers
Agencies Societies Journals

Ivy League “Thought- Tobacco
Treatment
Doctors Leaders” Scientists
Guidelines
Vaccines
Developed,
Hard to Catch, Easy to Cure, Tests
Accurate, non-Chronic Infection, Short Market
Mythology
Term Antibiotics Adequate Created
Lyme
Disease Easy to Catch, Difficult to Cure, Relapsing,
Reality Infection
Debilitating, Chronic Infection, Tests
Spreads,
Inaccurate/Politically Dumbed-Down,
Sophisticated, Long Term Antibiotics
Patients
Regimens Required
systematic
deterioration
Nightmare Doctors Patients monitored

EIS EIS
EIS

EIS IDSA
EIS

CDC
EIS
EIS

“ . . . It’s possible to see the
modern history of Lyme as a
string of events with an EIS
member at every crucial node.”
--Elena Cook

Tuskegee: Then and Now

CDC: Public Health Service
National Health Pretext

• Tuskegee I (Syphilis Spirochete)
– Spirochete victims (poor, uneducated) prevented from seeing doctors outside the
experimental system and getting antibiotic treatments
• In limited geographical area (Tuskegee Alabama)
– Chronic disease mislabeled to mislead and rationalize mis-treatment (syphilis
victims told they had “bad blood”)
– Contrived epidemic kills victims and spreads to families
– Researchers allowed to monitor effects of untreated syphilis on controls
– Overseen by USPHS/CDC with cooperation of medical societies (including AMA)

• Tuskegee II (Lyme Disease Spirochete)

CDC: Epidemic Intelligence Service
– Spirochete victims prevented from getting treatment from doctors from outside the
“system” (doctors eliminated, treatments dumbed-down)
• Unlimited geographical area
National Security Pretext

– Chronic disease mislabeled to mislead (chronic Lyme disease becomes “post-Lyme
syndrome”) and mis-treat
– Contrived epidemic kills victims and spreads to families, public at-large (well-
established mechanism of contagion--same as syphilis—denied by “experts”)
– Researchers allowed to monitor effects of untreated spirochete disease on “controls”
• Vaccines developed
• Market for vaccines simultaneously created
– Overseen by CDC/EIS in cooperation with medical societies (including IDSA)

The IDSA Guidelines:
Enforcement
• … the IDSA has … enforced its guidelines through the gatekeeping roles that its
members hold.

– Hospital medical staff committee physician members ensure compliance with the IDSA
guidelines by supporting the denial and revocation of hospital privileges of physicians who
do not comply.
– IDSA members also act as gatekeepers to … research grants, presentations at
conferences, and the publication of journal articles.
– IDSA physicians provide the preliminary expert external review of prospective medical board
conduct actions. Insurance companies use the guidelines to exclude non-complying
physicians from their networks, support second opinions from IDSA members, and to deny
reimbursement of claims for treatment not following guidelines.
– This type of exclusionary activity suppresses the dissemination of opposing viewpoints and
blocks many professional advancement opportunities.

• These “gatekeeper” enforcement actions send a clear message to physicians that
noncompliance may have serious professional consequences.

• Richard Wolfram
– Connecticut Attorney General Investigation and Settlement Highlights Possible Applicability of Antitrust Standard
Setting Law to the Development of Clinical Practice Guidelines

• The Emphasis On Symptom Treatments

The Addiction To Drug
Companies
• “The overall influence of the industry is to emphasize drug treatment
at the expense of other modalities: psychotherapy, social
approaches, nutritional, herbal, and natural remedies, rehabilitation,
general hygienic measures, non-patentable drugs, or other
alternative approaches.

• It focuses attention on disorders that are treatable by drugs, and
may promote over diagnosis. It reinforces the practice of dealing
with disease by treatment of symptoms, and diverts interest from
prevention.”

• Wortis, J., and Stone, A. The addiction to drug companies.
• Biol. Psychiatry 32:847-849, 1992

• Third-Party Organizations are used to promote symptom treatment
– Prevention from treating underlying symptoms

• “In addition to attempting to directly influence the highest levels of the
government, pharmaceutical companies in the US have begun to
develop a parallel strategy meant to manipulate public opinion. They
promote organizations that appear to be spontaneous initiatives and
are in reality supported and run by citizens that work for the
pharmaceutical companies and are paid to promote their interests “on the
ground” as it were, without being noticed.
» Sister Teresa Forcades, MD

– “Treatment Guidelines” by “independent medical societies” are the
perfect vehicle for Third-Party Organizations to emphasize symptom
treatments for one disease while ignoring the underlying infection that
caused it
• Treat symptoms in perpetuity
• Example: Lyme Disease and anti-depressants, arthritis treatments

Treating Symptoms

• Pharmaceutical windfalls (Miguel Perez-Lizano, June 2010)

– The denial of chronic Lyme disease by IDSA is an important factor
in pharmaceutical marketing. According to the IDSA Lyme guideline
authors, regardless of how long one has had the infection, how
entrenched it is in immune protected sites, or how disabling it is, a short
course of antibiotics will eradicate the disease from the body. This has
never been proven. Numerous scientific studies have shown IDSA’s
claims to be false.

– … according to IDSA, after a few weeks of antibiotic treatment a person
is “cured” of Lyme disease. Then, suddenly, ongoing symptoms are
due to some other unidentified problem which can be managed
with ongoing drug treatment. IDSA Lyme guideline authors have
known financial ties with pharmaceutical companies, making perfect
financial sense for this false claim of cure.

– It is only the undeserved clout of the CDC and IDSA and the
gullibility of the media that give this incredible information any credibility.

Treating Symptoms

• Pharmaceutical windfalls (Miguel Perez-Lizano, June 2010)

– The market for symptomatic treatment of Lyme disease through
pharmaceuticals is undoubtedly immense. The pharmaceutical market
for arthritis alone generated $15.9 billion in revenues in 2008.

– Worldwide sales of Parkinson's disease therapies will increase
modestly from $2.5 billion in 2008 to $2.8 billion in 2018 in the
United States, France, Germany, Italy, Spain, the United Kingdom and
Japan

– According to PharmaLive, pharmaceutical industry experts expect the
fibromyalgia drug market to quadruple to $2 billion by 2016.
Leonard Sigal, a rheumatologist and contributor to the IDSA Lyme
guidelines, is heavily involved with promoting fibromyalgia as an
alternative diagnosis. Sigal, a former academician, now works for a
pharmaceutical company He has also testified in legal cases, on behalf
of insurers, against Lyme disease doctors and victims.

The Lyme Cartel

• Leveraging public agencies and private medical
societies to subvert the medical system
– The IDSA (Infectious Disease Society of America)
• Created a “climate of opinion” that Lyme disease is “hard to
catch, easy to cure”, when the opposite is true
• Lyme Disease Treatment Guidelines unofficially adopted by
insurance companies as the prevailing wisdom in Lyme
disease to deny chronic Lyme Disease, to prevent chronic
payments
• Lyme Disease Treatment Guidelines severely limit the
amount of antibiotics a doctor can prescribe to his patients
• Doctors who dissent are often destroyed through
government agencies

IDSA Makes History

• 2008: A previously well-respected medical society (IDSA) was
investigated by the Attorney General of Connecticut for violating
anti-trust laws in dictating Lyme Disease treatment policy.

• 2009: An unprecedented move in medical history--the Attorney
General of Connecticut found that the IDSA’s expert “treatment
guidelines” were created within the context of major conflicts of
interest.
– The IDSA was forced to hold a hearing to allow physicians and patient
advocates to voice their disapproval of treatment guidelines that have
been used to foster a preventable epidemic.
– The goal was to rescind medical treatment guidelines by Ivory Tower
academics that have punished doctors and have left the patient
community suffering in agony.

Attorney General Findings:
Summary
• "My office uncovered undisclosed financial interests held by several
of the most powerful IDSA panelists. The IDSA's guideline panel
improperly ignored or minimized consideration of alternative medical
opinion and evidence regarding chronic Lyme disease, potentially
raising serious questions about whether the recommendations
reflected all relevant science.

Blumenthal added,

• "The IDSA's 2006 Lyme disease guideline panel undercut its
credibility by allowing individuals with financial interests -- in drug
companies, Lyme disease diagnostic tests, patents and consulting
arrangements with insurance companies -- to exclude divergent
medical evidence and opinion.

This Event Was Long Overdue

• Doctors in the field have been fighting a losing battle for
decades to treat their patients with effective antibiotic
regimens.

• The fight was with academic “experts” with ties to
insurance and pharmaceuticals companies (which
benefit from not treating the disease) and the
government agencies that are supposed to protecting
the public (but are in fact exploiting it).

Dr. Burrascano’s Vindication
• “There is a core group of university-based Lyme disease researchers and physicians
whose opinions carry a great deal of weight. …They work with government agencies
to bias the agenda of consensus meetings and have worked to exclude from those
meetings and scientific seminars those with alternate opinions.
• "Because of this bias by this inner circle, Lyme disease unfortunately is both
underdiagnosed and undertreated in this country to the great detriment of many of our
citizens."
-- Dr. Joseph Burrascano, Congressional Testimony, 1993

• “The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing
individuals with financial interests -- in drug companies, Lyme disease diagnostic
tests, patents and consulting arrangements with insurance companies -- to exclude
divergent medical evidence and opinion.

• The IDSA guidelines have sweeping and significant impacts on Lyme disease
medical care. They are commonly applied by insurance companies in restricting
coverage for long-term antibiotic treatment or other medical care and also strongly
influence physician treatment decisions.”

-- Connecticut Attorney General Richard Blumenthal, 2008

The IDSA Guidelines: Effects

• “Physicians who offer longer term treatment approaches run the risk of losing
hospital privileges, being denied malpractice insurance or having to pay higher
rates for this insurance, being terminated from insurance networks, and facing
professional misconduct actions.

• …in the case of long-term treatment of Lyme disease, complainants estimate fewer
than 150 physicians in the United States are willing to endure the pressures
from the IDSA and from insurance companies (by their refusal to cover long-term
antibiotic treatment). This number is down considerably from previous levels.

• It has become significantly more difficult for patients to obtain services of physicians
willing to treat long-term Lyme disease—many patients have to bear the costs of
traveling long distances for treatment and then pay for their non-insured treatment.”
– Richard Wolfram
• Connecticut Attorney General Investigation and Settlement Highlights Possible Applicability of
Antitrust Standard Setting Law to the Development of Clinical Practice Guidelines

The IDSA Guidelines: Effects
• Although a substantial body of scientific and empirical studies reports that long-term antibiotic
treatment can be effective and that the spirochete can persist in the body notwithstanding
“standard” courses of antibiotics, the IDSA has dismissed these findings as unsubstantiated.
Most insurance companies, citing the IDSA guidelines in support, deny coverage for antibiotic
treatment beyond 30 days.
• In the view of various complainants and the AG, the guidelines effectively deny physicians the
ability to use clinical discretion in diagnosing and treating Lyme disease, despite the IDSA’s
general disclaimer that its guidelines are not mandatory. The guidelines also provide no
additional treatment options, apart from palliative care, for patients who fail to improve under
treatments identified by the IDSA’s protocol.
• In contrast, the restraint in the matter of the Lyme guidelines has been palpable, with output
being suppressed (few physicians willing to treat) despite rising demand for treatment. Hence, in
complainants’ view, causation is established in this case based on reduced output caused by the
IDSA’s power to drive professional norms simply by virtue of its authority and dominance in the
marketplace (rather than on the merits of an open discussion, which it has the power to suppress
through its influence on information distribution channels).

– Richard Wolfram
• Connecticut Attorney General Investigation and Settlement Highlights Possible Applicability of Antitrust Standard Setting

Treatment Guidelines And Their
Authors Promote International
Epidemic Of Ignorance

Continuing Education:
Application

IDSA Guidelines Used in

• “The case studies are designed to educate clinicians
regarding the proper diagnosis and treatment of Lyme
disease and also provide an opportunity to better
understand the IDSA guideline.
• The cases included in this course were written by expert
faculty members, some of whom authored the guideline.
• At the completion of this course, participants will be
better able to:
– Evaluate and diagnose Lyme disease
– Utilize effective therapy to treat Lyme disease
– Review and interpret the IDSA guideline “The Clinical
Assessment, Treatment and Prevention of Lyme Disease,
Human Granulocytic Anaplasmosis and Babesiosis.”

Lyme Disease Cartel
• Doctors involved in eliminating other doctors for
treating an epidemic they claim doesn’t exist are
spreading disinformation under the guise of
education
• They have created a synthetic epidemic by
spreading disinformation and ignorance within
the medical system and mass-media

CDC, Harvard, Yale, Insurance
Companies, Pharma
• WORKGROUP
• Eugene Shapiro, MD, Professor of Pediatrics, Epidemiology & Public Health, and Investigative
Medicine, Yale University; Metropolitan Life Insurance Company: Reviewing claims of disability
related to Lyme disease; Served as an expert witness in medical-malpractice cases related to
Lyme disease; SUNY Downstate: Honoraria.

• Allen Steere, MD, Professor of Medicine, Harvard Medical School; NIH, The Dana Foundation,
G. Harold and Leila Y. Mathers Foundation, CDC: Research Grants/Contracts.

• Gary Wormser, MD, Chief of Infectious Diseases and Vice Chair Department of Medicine, New
York Medical College; Department of Justice: Expert testimony in a medical malpractice case
related to Lyme disease; Retained in other medical-malpractice cases involving Lyme disease;
NIH, Bio-Rad, and DiaSorin: Research Grants; Merck, Astra Zeneca, and Pfizer.

• Paul Mead, MD, Medical Officer, Centers for Disease Control and Prevention; Nothing to
disclose.

• INDEPENDENT REVIEWERS
• Paul Auwaerter, MD, Clinical Director, Division of Infectious Diseases, Johns Hopkins University
School of Medicine; Expert testimony in medical malpractice cases related to Lyme disease.

• Harry Gallis, MD, Consulting Professor of Medicine, Duke University Medical Center;
Genentech: Advisor/Consultant; Fortis-Spectrum: Advisor/Consultant.

• IDSA Guidelines are useful for
– creating demand for pharmaceuticals
products,
– reducing insurance payments and
– experimenting on the public,
– but not for treating them

The End Result?
• An artificially created epidemic
• Lyme patients left untreated, except for
symptoms
• Only pharmaceuticals companies and thought-
leaders profit

The Institutionalization of Tuskegee
Experimentation
http://www.publichealthalert.org/Articles/miscellaneous/tuskeegee%202.pdf

CDC Tuskegee Experiment, Phase II
Excerpt

• This is what is happening…

• The Tuskegee Experiment has been institutionalized.

• As a result of the use of treatment guidelines to deny treatment,
America's most egregious example of medical malpractice through
treatment-denial is now an everyday reality, conducted on a grand
scale, and run with the complicity of the CDC and other public
agencies, which are exploiting the public instead of protecting them.

• As a result, the newest version of the Tuskegee Experiment is not
only far more widespread than Phase I, but it also is far more
insidious, because it takes place through the creation and
enforcement of ghost-written treatment guidelines that are rapidly
becoming the standard way by which "Big Pharma" legislates profits
through the medical system and the government.

CDC Tuskegee Experiment, Phase II
Excerpt

• I believe 80 years of Tuskegee experimentation is enough! We need
to investigate the Lyme treatment denial scenario. But we also
need to investigate the mechanisms used to carry it out. There are
millions of sick Lyme patients in desperate need of antibiotics that
their doctors can't give them because of the CDC's policies
regarding pharma's treatment guidelines.

• But there is more at stake. The methodology used to run this state-
sanctioned experiment in treatment denial for Lyme patients could
be used in the "non-treatment" of other diseases potentially creating
billions of future victims.

• We desperately need to understand how treatment guidelines are
being created and enforced by the pharmaceuticals industry with the
complicity of public health agencies, to the detriment of public
health. We also need laws to protect us so that this insidious, covert
experimentation is never perpetrated on the American public again.

The Subversion of Medicine Through Treatment Guidelines

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