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

• “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

Preface

The Subversion Of Modern Medicine Through The Proliferation of

“Treatment Guidelines”

Jerry Leonard

Part Two

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

Review of Part 1

"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 WolframConnecticut 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 Law to the Development of Clinical Practice Guidelines

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.

Treatment Guidelines

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

--Richard WolframConnecticut 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

Doctors

Treatment

Insurance Companies

Treatment Guidelines

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

Pharmaceuticals Companies

Doctors

“Treatment”

Insurance Companies

Treatment Guidelines3rd Party Groups

Non-Profits

Medical Societies

$$$

$$$

Medical Education & Communications

Companies (MECCs)

“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)

How To Practice Medicine Without a License3rd-Party Strategy

Pharmaceuticals Companies

Doctors

“Treatment”

Insurance Companies

Treatment Guidelines3rd Party Groups

Non-Profits

Medical Societies

$$$

$$$

Medical Education & Communications

Companies (MECCs)

“Evidence-Based Medicine”

“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

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

Treatment Guidelines

Pharmaceuticals Companies

“Ivy League” Professors

Medical Journals

Government Agencies

State Medical Boards

“Thought Leaders”

Study 1

Study 2

Study 3 Insurance Companies

x

x

√

Study 3 √

Media Monopoly“Experts”

$

$

$

Study 4 x$

Medical Societies

“Medical Education”

With negative results not disclosed, researchers and physicians often believe that drugs are more effective and safer than they actually are, according to Dr. Marcia Angell, a former editor of The New England Journal of Medicine. ''It changes the way medicine is practiced,'' Dr. Angell said.

Doctors Options Limited

Doctors access to information limited Dissenting doctors and researchers put of business (“Sham Peer 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

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 the state’s Medicaid preferred drug list and on controversial medical protocols that determine which drugs are given to adults and children in state custody, the paper writes.

• Texas has spent millions of state Medicaid dollars on the drug, which some recent studies show performs no better than cheap generics, and can lead to diabetes and excessive weight gain, 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).’

“J&J’s Janssen Pharmaceutica deployed phony advocacy groups to get its Risperdal antipsychotic prescribed to low-income Texans… “

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‘)

How To Practice Medicine Without a License

Treatment Guidelines

Pharmaceuticals Companies

“Ivy League” Professors

Medical Journals

Doctors Options Limited

Doctors access to information limited Dissenting doctors and researchers put of business (“Sham Peer Review”, grants denied)

Government Agencies

State Medical Boards

“Thought Leaders”

Study 1

Study 2

Study 3 Insurance Companies

x

x

√

Study 3 √

Media Monopoly

“Experts”

$

$

$

Study 4 x$

Medical Societies

“Medical Education”

The Cartel

• 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.’

Part II

Drug Marketing Strategy

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

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

“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

How To Practice Medicine Without a License

Pharmaceuticals Companies

Doctors

Treatment

Insurance Companies

Treatment Guidelines3rd Party Groups

Non-Profits

Medical Societies

$$$

$$$

Medical Education & Communications

Companies (MECCs)

“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

“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 SummarySymptom 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 SummarySymptom Generator

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

The New Great Imitator

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 …

How To Practice Medicine Without a License (And Make Lots of Money)

Doctors

Treatment I Treatment IIITreatment II

DoctorsDoctors

Diseased Patients Symptom CSymptom BSymptom A Symptom D

Treatment GuidelinesSymptom-Oriented

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

Proposed Model For Treatment Denial

Pharmaceuticals Companies

Ivy League Professors

State Medical Boards

Medical Journals

Doctors

Mass MediaMedical Societies

Treatment I Treatment IIITreatment II

NIH, FDA, CDC, EIS

DoctorsDoctors

$$$$$$

Continuing Education

Information CartelIntellectual Cartel

Insurance Companies

Diseased Patients Symptom CSymptom BSymptom A Symptom D

Treatment GuidelinesSymptom-Oriented

“Cartel”

“Consigliere”

How To Practice Medicine Without a License

Pharmaceuticals Companies

Ivy League Professors

State Medical Boards

Medical Journals

Doctors

Mass MediaMedical Societies

Treatment I Treatment IIITreatment II

NIH, FDA, CDC, EIS

DoctorsDoctors

$$$$$$

Continuing Education

Information CartelIntellectual Cartel

Insurance Companies

Diseased Patients Symptom CSymptom BSymptom A Symptom D

Treatment GuidelinesSymptom-Oriented

“Lyme Cartel”

“Consigliere”

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 pagesdoi: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.

Systematic Denial of Care

• 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.

Systematic Denial of Care

• 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?

vs

Insurance Companies

Pharmaceuticals Companies

Medical Societies

Government Agencies

Medical Journals

Cartel

Tobacco Scientists

Profit from treatment of symptoms, not treatment of underlying infection

Disease Mythology

Ivy League Doctors

Mandating Markets Through Treatment Guidelines

Grants

State Medical Boards

Doctors

Mass Media

Untreated Patients

“Voluntary TreatmentGuidelines”

“Voluntary Guidelines” Enforcement

Disease Reality

$Consulting Fees

Consulting Fees

Reduced Payout = Increased ProfitsSymptom Treatments, Vaccines

“Expert” Witnesses

Thought-Leaders

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

“Voluntary Guidelines” Enforcement

vs

Insurance Companies

Pharmaceuticals Companies

Medical Societies

Government Agencies

Medical Journals

Cartel

Tobacco Scientists

Profit from treatment of symptoms, not treatment of underlying infection

Disease Mythology

Ivy League Doctors

Mandating Markets Through Treatment Guidelines

Grants

State Medical Boards

Doctors

Mass Media

Untreated Patients

“Voluntary TreatmentGuidelines”

“Voluntary Guidelines” Enforcement

Disease Reality

Patent OwnersBusiness Owners

$

Reduced Payout = Increased ProfitsSymptom Treatments, Vaccines

“Expert” Witnesses

Thought-Leaders

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

“Voluntary Guidelines” Enforcement

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

Mythology

Reality

Doctors Patients

Insurance Companies

Pharmaceuticals Companies

Medical Societies

Government Agencies

“Thought-Leaders”

Medical Journals

Hard to Catch, Easy to Cure, Tests Accurate, non-Chronic Infection, Short Term Antibiotics Adequate

Infection Spreads,

Easy to Catch, Difficult to Cure, Relapsing, Debilitating, Chronic Infection, Tests Inaccurate/Politically Dumbed-Down, Sophisticated, Long Term Antibiotics Regimens Required

Dream World

Nightmare

Tobacco Scientists

Vaccines Developed,

Profit from non-treatment of underlying infection

Technical and ideological enablers

Lyme Disease

Ivy League Doctors

Patients systematic deterioration monitored

Market Created

Treatment Guidelines

CDC

EIS

IDSA

EIS EIS

EIS EIS

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

• 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)– Spirochete victims prevented from getting treatment from doctors from outside the

“system” (doctors eliminated, treatments dumbed-down)• Unlimited geographical area

– 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)

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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

“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

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.

• 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

The Lyme Cartel

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

• Enforcing the Guidelines

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

Law to the Development of Clinical Practice Guidelines

Treatment Guidelines And Their Authors Promote International

Epidemic Of Ignorance

How To Practice Medicine Without a License

Pharmaceuticals Companies

Ivy League Professors

State Medical Boards

Medical Journals

Doctors

Mass MediaMedical Societies

Treatment I Treatment IIITreatment II

NIH, FDA, CDC, EIS

DoctorsDoctors

$$$$$$

Continuing Education

Information CartelIntellectual Cartel

Insurance Companies

Diseased Patients Symptom CSymptom BSymptom A Symptom D

Treatment GuidelinesSymptom-Oriented

“Lyme Cartel”

“Consigliere”

Continuing Education: Application

IDSA Guidelines Used in Continuing Education

• “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

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• 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.