The Infectious Diseases Society of America Lyme guidelines: A cautionary tale about the development of clinical practice guidelines

Abstract

Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write treatment guidelines are particularly problematic, because panelists may have conflicting agendas that influence guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels. However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, the Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines development process, the subsequent review of the guidelines mandated by the settlement was compromised by a lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in the implementation of the IDSA antitrust settlement that should be avoided in the future.

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Research
The Infectious Diseases Society of America Lyme
guidelines: a cautionary tale about the
development of clinical practice guidelines
Lorraine Johnson
1,2
and Raphael B Stricker*
1,2
Abstract
Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write
treatment guidelines are particularly problematic, because panelists may have conflicting agendas that influence
guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels.
However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into
the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, the
Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines
development process, the subsequent review of the guidelines mandated by the settlement was compromised by a
lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the
recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws
as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in
the implementation of the IDSA antitrust settlement that should be avoided in the future.
Introduction
'Without health, there is no happiness'. Thomas Jeffer-
son
'The strong do what they can; the weak endure what
they must'. Thucydides
With the trend toward centralized medical decision
making and evidence-based medicine, clinical practice
guidelines are becoming a key factor in the practice of
medicine and are increasingly relied upon by physicians
seeking treatment guidance. However, when guidelines
panels fail to conscientiously safeguard the integrity of
the guideline development process, the quality of guide-
lines may be eroded and fall short of the primary goal of
guidelines--namely improving patient outcomes [1]. The
Connecticut Attorney General's antitrust investigation
into the Lyme disease treatment guidelines development
process of the Infectious Diseases Society of America
(IDSA) underscores the importance of these problems
and the need for guidelines reform [2].
Guidelines have become a way to drive the medical
standard of care that governs physician conduct. When
inflexible guidelines are adhered to by insurers, govern-
ment agencies, medical societies and hospitals, guidelines
can essentially create a de facto regulatory scheme
fraught with economic, legal, and patient care conse-
quences. Accordingly, guidelines, particularly those for-
mulated by medical societies that are considered
dominant under antitrust laws, hold enormous influence
over the practice of medicine, creating a situation that is
ripe for abuse [3]. For example, third parties such as the
insurance industry and pharmaceutical companies whose
commercial interests may be affected by guidelines may
seek to influence the guidelines development process
through the use of 'key opinion leaders' (typically aca-
demic researchers) who serve on guidelines panels. The
enormous influence of clinical practice guidelines also
creates the potential for the guidelines of a dominant
medical society to be used competitively against less
influential medical societies.
The primary goal of clinical practice guidelines is to
improve patient care. However, in general, patient inter-
ests are not directly represented on guidelines panels.
* Correspondence: rstricker@usmamed.com
1 California Lyme Disease Association, Ukiah, CA, USA
Full list of author information is available at the end of the article

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Guidelines that limit patient treatment options may
essentially set public policy without the benefit of public
debate or the participation of significant stakeholders.
When divergent treatment approaches exist and guide-
lines fail to acknowledge these or provide treatment
options, they may deprive patients of the right to make
the treatment choices that lie at the heart of autonomy.
Despite the potential for clinical practice guidelines to
restrict patient care, to promote the interests of commer-
cial third parties, and to be misused by medical societies
against their competitors, guidelines have remained
largely unregulated. The potential for guidelines abuse
has sparked calls for reform in recent articles highlighting
issues that may undermine the validity of these guide-
lines. These issues include conflicts of interest on guide-
line panels, the relative paucity of evidence supporting
many guideline recommendations, the over-reliance on
expert opinion, the false appearance of unanimity of
opinion presented in guidelines, the failure to acknowl-
edge legitimate controversy, the lack of rigorous external
peer review when medical specialty societies self-publish
guidelines, and the interference with the legitimate exer-
cise of clinical judgment created by inflexible recommen-
dations [1,4-6].
Traditionally, there has been no legal remedy for a
flawed guideline development process. However, in
November 2006, the Attorney General of Connecticut
launched a ground-breaking antitrust investigation into
the development of Lyme disease treatment guidelines by
IDSA, one of the largest medical societies in the United
States [2]. As discussed below, antitrust law is concerned
with abuses of power by those who have it. Ultimately,
antitrust laws focus on actions by 'dominant' organiza-
tions that constrain consumer choice and employ 'exclu-
sionary conduct' to suppress the views of competitors. In
medicine, guidelines that limit the access of patients to
treatment options may constrain consumer choice. The
emphasis of antitrust law in the context of treatment
guidelines is on the fairness or integrity of the guideline
development process.
The Connecticut Attorney General's investigation
found significant irregularities in the IDSA Lyme guide-
line development process, including significant conflicts
of interest among the guidelines panel members. These
issues parallel those underlying recent calls for guideline
reform. The settlement of the investigation required
IDSA to review its guidelines with a new panel that is free
from these conflicts. The findings of that investigation,
the settlement of that investigation, and the mechanics of
the settlement process were discussed in detail in a previ-
ous article by the authors [7]. This article will examine
the recent calls for guidelines reform in the context of the
IDSA antitrust investigation and settlement and the
interplay between medical ethics canons, guideline
reform, and due process considerations under antitrust
laws.
The Lyme disease controversy and IDSA guidelines
The diagnosis and treatment of Lyme disease is highly
controversial, especially when the initial tickborne illness
is not recognized and symptomatic disease persists [8].
The level of disability of patients with persistent Lyme
disease symptoms is equal to that of patients with conges-
tive heart failure [8]. The spirochetal bacterium that
causes Lyme disease was first identified in 1982, and the
state of Lyme disease science is best described as emerg-
ing, with many gaps in research remaining to be filled.
The handful of treatment studies for Lyme disease have
faced significant design challenges, produced conflicting
results and involved small sample sizes. Consequently the
studies suffer from limited generalizability when applied
to a clinical patient population that is heterogeneous [9].
In the past decade, two opposing camps have emerged
in the battle over the tick-borne illness. One is repre-
sented by IDSA, which maintains that Lyme disease can
be treated with short courses of antibiotics and that per-
sistent infection is rare or non-existent [10]. The oppos-
ing camp is represented by the International Lyme and
Associated Diseases Society (ILADS), which notes the
high failure rate of short courses of antibiotics for dissem-
inated Lyme disease and maintains that the underlying
infection may persist in a large number of patients and
require prolonged antibiotic therapy [11,12]. The contro-
versy between the two camps has been labeled the 'Lyme
Wars' [13].
Despite the emerging state of the science and consider-
able uncertainty about the disease, the playing field for
this debate between the warring factions has been far
from even. IDSA is widely recognized as the preeminent
infectious disease specialty society in the United States
and publishes two of the three most influential infectious
disease journals [14,15]. Its members exert strong influ-
ence on peer review for medical journals by serving as
peer reviewers and editors. For instance, one member of
the IDSA Lyme guidelines panel provides peer review for
over 30 medical journals [16]. IDSA also has considerable
power over antibiotic treatment protocols in hospitals,
which typically employ an infectious disease consultant
to establish and monitor the use of antibiotics in the hos-
pital. Hence, the ability to identify and target noncomply-
ing physicians may 'induce hospitals to deny or revoke
hospital privileges for physicians who do not comply with
(IDSA) guidelines,' thus permitting IDSA-affiliated physi-
cians to act as gatekeepers for hospital staff privileges
[17].
IDSA guidelines may serve as a proxy for the standard
of care applied by medical boards in unprofessional con-
duct actions. Before commencing an action, medical

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boards commonly refer potential actions out for 'expert'
review by members of IDSA [17]. In addition, IDSA-affil-
iated physicians testify against non-complying physicians
in unprofessional conduct actions [18]. When organiza-
tions wield this amount of power, they can run afoul of
antitrust law if they attempt to exclude competing view-
points, fail to control conflicts of interest, and restrict
consumer choice.
In 2005, IDSA seated a panel to develop revised Lyme
treatment guidelines. Under the prior IDSA Lyme guide-
lines published in 2000, a number of physicians had been
subjected to unprofessional conduct actions for failure to
comply with the guidelines, insurance companies were
denying patient reimbursement for treatment that was
not in compliance with the guidelines, and patients were
having difficulty finding physicians willing to treat their
illness [7]. A number of physicians with divergent view-
points, including some members of IDSA, applied for a
seat on the panel, but they were rejected by IDSA ostensi-
bly on the basis that the panel was full, although the num-
ber of panelists was subsequently increased [2].
The revised Lyme guidelines were published in October
2006 [10]. As most patients and their treating physicians
feared, the guidelines restricted the management of
patients by the treating physician. Nineteen members of
the U.S. Congress sent a letter to the Centers for Disease
Control and Prevention (CDC) requesting a review of
guidelines that 'had the potential to effectively shut down'
treatment of chronic Lyme disease [19]. As the authors
have noted elsewhere, because the guidelines do not pro-
vide for treatment options or the exercise of clinical judg-
ment by physicians, they may be viewed as a mandatory
standard of care by medical societies, government agen-
cies, and insurance companies that may adopt the guide-
lines based on the reputation, specialty dominance, and
distribution power of IDSA [7].
IDSA contends that it does not intend for its guidelines
to be applied as mandatory treatment protocols [20].
However, the guidelines do not provide for treatment
options or the exercise of clinical discretion, and they fail
to acknowledge the existence of divergent treatment
approaches [10]. Although the guidelines contain the
usual formulaic disclaimer regarding clinical judgment,
this disclaimer does nothing to overcome the treatment
restrictions that are inherent in the guidelines. Other
medical societies expressly provide for treatment options
when guidelines are not mandatory [21]. Moreover,
IDSA's assertion that the guidelines are not mandatory is
at odds with two practical realities: IDSA members testify
against physicians who fail to comply with the IDSA
Lyme guidelines, and IDSA opposes state legislation
designed to protect its competitors from unprofessional
conduct actions based on those guidelines [14,18].
Matters ultimately came to a head in Connecticut,
which has the highest incidence of reported Lyme cases
in the nation and is ground zero for the 'Lyme Wars'. The
California Lyme Disease Association (CALDA) spear-
headed a national effort with other advocacy groups,
including the national Lyme Disease Association and
Connecticut-based Time for Lyme. Focusing on antitrust
law as a vehicle to address the restrictive guidelines, the
groups approached the Attorney General of Connecticut,
Richard Blumenthal, who responded by launching an
antitrust investigation.
The authors of this article stand on the minority side of
this debate, and the first author was instrumental in
developing the antitrust theory with a colleague, Richard
Wolfram, a New York-based antitrust attorney, and in
presenting that theory to the Connecticut Attorney Gen-
eral. Each of the authors serves on the board of directors
of CALDA and ILADS, although this article has been
written in their individual, rather than organizational
capacities. In addition both presented testimony before
the IDSA Lyme guidelines review panel.
The application of antitrust law to the development
of treatment guidelines
Treatment guidelines are intended to influence physician
practices and may be used to discourage competing view-
points. A recent article in the Journal of the American
Medical Association by Sniderman and Furberg explains
the competitive aspects of guidelines: 'By favoring one
test over another, or one therapy over another, guidelines
often create commercial winners and losers, who cannot
be disinterested in the result and who therefore must be
separated from the process' [4]. Antitrust laws are
intended to 'promote competition and level the playing
field in our marketplace' [22]. IDSA is considered domi-
nant under antitrust laws and its guidelines are consid-
ered authoritative in the area of infectious diseases.
When Attorney General Blumenthal launched the anti-
trust investigation against IDSA, he stated that the pur-
pose of the investigation was to determine whether the
IDSA guidelines 'constrain choices by patients or doctors
in a way that could be anticompetitive'[23]. Although
antitrust issues have arisen in other contexts in medicine
in the past, the Connecticut investigation marks the first
time that the development process for treatment guide-
lines has come under antitrust scrutiny.
The investigation arose out of the doctrine of 'standard-
setting' in antitrust law. Standards are pervasive; they may
be simple or complex, and may include safety standards
for products. Typically, in the process of setting stan-
dards, firms compete in an organized, structured process
for their technology or products to be incorporated into a
standard. This process preempts market choices, but usu-

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ally passes antitrust muster because it yields pro-compet-
itive efficiencies that benefit consumers.
According to Richard Wolfram, the antitrust attorney
in New York who was involved in the investigation,
'Because standard setting by competitors supplants com-
petition, the process must be fair, open, and not subject to
any bias by participants with economic interests in sti-
fling completion, especially when the standard-setting is
done by an association...that is highly influential or domi-
nant in the relevant market place'[17]. Although IDSA
claims that the antitrust investigation is a case of the gov-
ernment meddling with medicine, antitrust law is not
concerned with calling the science; instead it requires
that the development process should be fair, non-exclu-
sionary, and not tainted by conflicts of interest [17].
Recent calls for guidelines reform
Flaws in the development of guidelines that are related to
conflicts of interest, bias among the members of the
guidelines panel, and suppression of competing view-
points were central to the antitrust investigation of IDSA
by Attorney General Blumenthal. Moreover, these flaws
mirror the growing list of problems with evidence-based
guidelines in general, which has led many to call for
reform in how guidelines are developed [4]. In their arti-
cle in the Journal of the American Medical Association,
Sniderman and Furberg highlighted critical deficiencies
in the current process:
• Conflicts of interest of 'experts' on guidelines panels
may substantively drive the content of the guidelines
in a manner that does not hold the interest of the
patient paramount.
• A paucity of high-level evidence and an overreliance
on 'expert opinion' may result in the formulation of
guidelines that merely replace one 'authority-based'
system with another.
• Legitimate controversy may be suppressed by artifi-
cially 'unanimous' panel recommendations and by the
exclusion of divergent viewpoints from the panel.
• Specialty medical societies, which use guidelines to
expand their competitive sphere of influence, may
publish guidelines in their own journals essentially
'as-is,' without submitting them to the type of inde-
pendent, external peer review that might vet issues of
bias or conflicts of interest on the part of guidelines
panel members [4].
All of these aspects undermine the credibility of guide-
lines and permit personal bias to determine the care of
patients -- the very problem that evidence-based guide-
lines are intended to avoid. Indeed, these deficiencies may
undermine the ethical foundation of medicine, which
requires 'physicians to put the needs of patients ahead of
personal gain, to deal with patients honestly, compe-
tently, and compassionately, and to avoid conflicts of
interest that could undermine public trust in the altruism
of medicine' [24].
The integrity of medicine, and, ultimately, its value to
society depends upon recognizing and safeguarding this
ethical foundation. Sniderman and Furberg highlight the
most important components of that ethics foundation in
the context of guidelines: conflicts of interest, overreli-
ance on expert opinion, and failure to acknowledge legiti-
mate controversy. Distilled down to their essence, these
issues are based on two ethical principles: the need to
hold the interests of the patient above other commercial
interests and the need to preserve the 'treatment choice'
that gives life to the ethical principle of autonomy.
The ethical obligation to hold patient's interests para-
mount can be compromised by conflicts of interest
resulting from financial ties of the panel members. The
ethical obligation to respect patient autonomy depends
upon the preservation of treatment choice for patients
and can be jeopardized when guidelines fail to acknowl-
edge legitimate controversy and do not provide treatment
options. Choice is also jeopardized when there is a pau-
city of evidence and evidence gaps are filled by the 'expert
opinion' of the panel. The problems that arise from con-
flicts of interest and failure to preserve treatment choice
are furthered when the medical specialty societies that
sponsor and publish these guidelines fail to adequately
police these risks or have industry ties themselves. The
issues regarding guidelines development and conflicts of
interest, quality of evidence, and patient choice are dis-
cussed in more detail below.
Conflicts of Interest
One of the paramount deficiencies identified by Snider-
man and Furberg in guidelines development arises from
conflicts of interest. The Institute of Medicine (IOM)
defines a conflict of interest as 'a set of circumstances that
creates a risk that professional judgment or actions
regarding a primary interest will be unduly influenced by
a secondary interest' [25]. This determination requires
identifying a primary interest and a secondary interest.
The primary goal of medicine that should stand at the
center of treatment guidelines is to '[improve] health by
providing beneficial care to patients' [25]. Secondary
interests 'may include not only financial gain but also the
desire for professional advancement [and] recognition for
personal achievement' [25]. This emphasis on primary
versus secondary interests arises from the divergent goals
of medicine (improving patient health outcomes) and
commerce (ensuring a financial return to shareholders)
[25].
Not all conflicts are of equal severity. The IOM suggests
that conflicts should be assessed by considering both the
likelihood of adversely affecting the primary interest and
the seriousness of the harm caused by the conflict:

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Likelihood depends on the value of the secondary
interest, the scope of the relationship between the
professionals and the commercial interests, and the
extent of discretion that the professionals have. Seri-
ousness depends on the value of the primary interest,
the scope of the consequences that affect it, and the
extent of accountability of the professionals [25].
Because they may affect multiple patient care decisions
and criteria for insurance coverage, clinical practice
guidelines are considered by the IOM to have a serious
potential for harm [25]. This is compounded by the fact
that guidelines panels have not usually been held to be
legally accountable to patients under malpractice laws
because the duty of care that creates liability exposure
only arises in the context of a direct physician-to-patient
relationship [26]. Discretion of those on guidelines panels
increases when the scientific evidence base is weak and
the panel elects to plug evidence gaps with 'expert opin-
ion' rather than acknowledging the uncertainty and pro-
viding treatment options. These factors increase the risk
and seriousness of harm to patients and emphasize the
importance of managing conflicts of interest. Parentheti-
cally, the growing importance of guidelines in public pol-
icy may increase the application of negligence and strict
liability law to their development process [26].
Unfortunately, conflicts of interest on guidelines panels
are common. It is not unusual for 'expert' panels to
include 'key opinion leaders', usually academic research-
ers for whom industry ties are vital to ensure the research
funding on which their careers depend [27]. Choudhry
and colleagues found that 87 percent of participating
'experts' had financial ties to pharmaceutical companies,
and 59 percent had ties to companies whose products
were considered in the guidelines authored by the
'experts' [27]. The roll call of guidelines formulated by
'conflicted panels' that appear to further the interests of
pharmaceutical companies includes those for the treat-
ment of sepsis, anemia among kidney patients, and high
cholesterol [28]. A New York Times article commented
that a conflicted guidelines panel that adopted an indus-
try-friendly new definition of high blood pressure 'illus-
trate[d] connections -- among the pharmaceutical
industry, academic physicians and societies that formu-
late opinion -- that can ultimately affect patient treat-
ment,'[29] and called this 'the monetarization of
medicine' [29].
A central value of research is the pursuit of objective,
unbiased information, and many 'key opinion leaders'
believe that they can rise above commercial conflicts of
interest [27]. Common sense and recent investigations
indicate the opposite [30]. When money enters the equa-
tion, the nature of the debate simply changes: for exam-
ple, Choudhry and colleagues found that research articles
have either been published or discretely shelved based on
ties to industry [27].
Choudhry and colleagues argued that the subtle influ-
ence of money on 'key opinion leaders' forms the basis of
a substantial portion of pharmaceutical marketing to pro-
mote the industry's interests [27]. Nonetheless, they
noted that the vast majority of researchers believe that at
least their own research is not compromised by monetary
ties with industry [27]. The Association of American
Medical Colleges reported that, in contrast to deliberate
corruption, many ethical problems in the professions are
based on unconscious bias that permeates professional
conduct; that is, professionals with conflicts of interest
may selectively seek out information, may interpret infor-
mation in a biased fashion, and may easily be derailed
from good intentions, but are typically unaware of these
effects [31].
When researchers dominate the panels that write
guidelines, they may bring their research biases with
them. Ernst and Canter describe the adverse effects that
bias may have on research:
Bias is ubiquitous, and medical research is no excep-
tion. From the very outset, investigator bias can influ-
ence the general attitude towards a research
project....The biased researcher, however, has precon-
ceived ideas and is likely to approach a project to
prove a point. For example, a researcher who is con-
vinced of a particular treatment or, worse, has a
vested interest in it, could misuse science to demon-
strate the efficacy of his therapy. Equally, an investiga-
tor with a preconceived negative attitude towards a
particular intervention can set out to disprove its effi-
cacy [32].
While some bias is unavoidable, biases introduced by
conflicts of interest frequently are and should be avoided
to the extent possible.
Academic researchers who sit on panels may have con-
flicts of interest not only in the form of industry ties (par-
ticularly if they are regarded as 'key opinion leaders'), but
also other competing financial interests identified by the
IOM, like career advancement or recognition of personal
achievements [25]. For example, citing their own research
in guidelines may promote both future research funding
and further their academic careers [27]. A report from
the Institute for Clinical Research and Health Policy
Studies at Tufts University describes researchers who
have staked their careers on a particular theory and con-
cludes that they 'are likely to resist accepting that the
whole field in which they have spent their lives is a null
field'[33]. These factors may impair the ability of guide-
lines panel members to critically select and evaluate
research findings in an unbiased fashion.

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In addition, serving on treatment guidelines panels is
part and parcel of being a 'key opinion leader'. In his
pharmaceutical marketing textbook, Ronald Evens, a pro-
fessor at University of Florida, College of Pharmacy,
states:
[I]t is paramount to identify national and regional
influencers, that can help guide registrational trial
program development, conduct solid and timely clini-
cal research, generate leading disease state publica-
tions, help draft treatment guidelines, and begin
cultivating potential speakers to help leverage clinical
trial product use immediately post drug approval [34].
Conflict of interest policies typically screen for conflicts
within the last year or two years, and 'key opinion leader'
relationships with industry may span a career [35]. For
example, one researcher on the IDSA Lyme guidelines
panel, Allen Steere, has relationships spanning more than
a decade with Lyme vaccine manufacturers [10,36,37].
Although researchers often develop a known expertise
and significant influence in a research area, these 'key
opinion leaders' may change their affiliations with phar-
maceutical companies over a given time frame. Thus it
may be unrealistic to assume that conflicts of interest
among 'key opinion leaders' are adequately reflected by a
time-delimited inquiry.
In addition to the conflicts of interest of individual
panel members, the medical society that sponsors and
publishes the guidelines may have conflicts of interest [4].
Industry funding of medical societies is extensive [5]. A
recent IOM report reviewed the budget of the American
Association of Family Physicians for the fiscal year 2006-
2007. Less than 38% of its $80 million budget came from
membership dues and services, while 42% came from the
pharmaceutical industry, (60% from advertising in the
academy's journal and 13% from exhibit fees) [25].
Although medical societies profess to operate for the
public good, Noble and colleagues observed that '[g]uide-
lines promulgated by a particular medical society gener-
ally reflect the specific concerns of its members' [26]. The
behavior of societies may not only further their own eco-
nomic interests, but may also take advantage of opportu-
nities to 'sit in judgment of their competitors' [38].
Treatment guidelines expand the society's sphere of influ-
ence, and, according to the IOM, medical specialty soci-
eties regard guidelines as one of the most valued services
they provide [25]. These factors suggest that the interests
of medical societies (and those of the individuals serving
on a guidelines panel) may not align with the best inter-
ests of patients, their professional competitors, or the
interests of the broader public [5].
Moreover, as Sniderman and Furberg noted, 'Few asso-
ciations submit the final products of the guideline process
for external review before they are accepted and, there-
fore, in a limited but real sense, the committee, which is a
creation of the organization, becomes the final arbiter of
its process,' bypassing 'one of the core processes of sci-
ence,' the type of review that might hold these self-inter-
ests in check [4].
How should conflicts of interest issues be addressed in
the guideline development process? In testimony before
the Institute of Medicine, Merrill Goozner, Director of
the Integrity in Science Project at the Center for Science
in the Public Interest, emphasized the need to maintain
strong boundaries between those who determine how
medicine gets practiced and researchers who conduct
industry-funded research [39]. The IOM agreed:
Given the important role that clinical practice guide-
lines play in many aspects of health care, it is impor-
tant that these guidelines be free of industry influence
and be viewed by clinicians, policy makers, patients,
and others as objective and trustworthy [25].
But what if conflicts of interest are the price of exper-
tise, as is often argued? The IOM provided further guid-
ance on this point.
If groups conclude that participants with conflicts of
interest are essential to provide the necessary exper-
tise, they should demonstrate to the public that they
have made a good faith but unsuccessful effort to find
individuals with the required expertise and without
conflicts of interests. They should preclude individu-
als with conflicts of interest from chairing guideline
development panels, restrict the number of individu-
als with conflicts of interest on panels to a distinct
minority (e.g., to 25-30 percent of the membership),
and prohibit members with conflicts of interest from
drafting and deciding specific recommendations [25].
Hence, 'key opinion leaders' with industry-related con-
flicts of interests ideally should be excluded from guide-
lines panels. Where this is not possible, the influence of
these individuals should be regulated by limiting partici-
pation to no more than 25-30% of the panel and other-
wise restricting the leadership role of those with conflicts
of interest.
Quality of Evidence
The implicit goal of evidence-based medicine is the pro-
vision of medical care that is grounded in science. How-
ever, the medical research base lags far behind in
providing the clinical evidence that physicians need to
treat patients, and the majority of recommendations in
most treatment guidelines are not based on high-quality
medical research studies [40].
Given our reliance on evidence-based guidelines, this
shortfall in evidence is disturbing [6]. The IOM reported
that '[a] review of guidelines in the National Guidelines
Clearinghouse reveals recommendation after recommen-
dation that is supported by weak, mixed, or no evidence'
[25]. McAllister and colleagues found that only 68% of the

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recommendations in guidelines cited randomized con-
trolled trials, and less than 30% were high-quality studies
that could be applied to the patient population [40].
At issue is not only the level of the evidence that is cited
(for example, controlled studies versus non-controlled
studies), but also the internal and external validity of the
research, including the size of samples, the endpoints that
are evaluated, and the generalizability of the study to the
patient population in the medical community at large.
Ioannides and colleagues' analysis of research studies
concluded that 'for most study designs and settings, it is
more likely for a research claim to be false than true' [33].
The problem when the 'evidence' in evidence-based
medicine does not deliver is the misperception, as Snider-
man and Furberg noted, that 'guidelines are evidence
based, not opinion based, and therefore their conclusions
flow directly from the conclusions of studies' [4]. Bias cre-
ated by conflicts of interest on guidelines panels is exac-
erbated when evidence is weak. Under these
circumstances, the real question is not what is 'right', but
who decides.
Although evidence based medicine regards the ran-
domized controlled trial as the gold standard, many
forms of medical evidence exist. Scott Sehon of the
Department of Philosophy at Bowdoin College describes
the available broader evidence base:
[C]linical experience, observational studies, and RCTs
have much in common. All are attempting to ascer-
tain the safety and efficacy of interventions, and all do
so by trying the intervention and noting the
results....In each case, we will observe the treatment
received by a patient, and then we will observe the
outcome or endpoint for each patient [41].
With each of these three forms of evidence, knowledge
is based on probability. Hence, to the physician 'knowing
a diagnosis means. . .the diagnosis is highly probable [but]
not absolute'[42]. The same holds true for observational
studies and RCTs, which are based on statistical averages
that may or may not apply to a heterogeneous patient
population. In any event, regardless of the pretreatment
probabilities and the type of evidence employed, the
'absolute' can only be determined by the response of an
individual patient to a specific treatment.
The issue of which evidence base should carry more
weight in a particular recommendation is important. Put
another way, the question is whether centralized medical
decision making or individualized care should be given
more weight. When the base of evidence is weak, non-
existent, or conflicting, the treating physician may
become the proverbial one-eyed king in the land of the
blind. The clinician alone holds a key to the puzzle that is
unavailable to members of a remote guidelines panel:
patient histories, physical examination findings, and the
patient's responsiveness to treatment. The American
Academy of Pediatrics directly tackled this issue in its
guidelines on creating guidelines: 'When the evidence is
of low quality and the benefit-harm equilibrium is bal-
anced, guideline developers generally should not con-
strain the clinician's discretion by making a
recommendation but instead should designate acceptable
alternatives as options'[21].
Patient Choice
Evidence shortfalls that are filled with 'expert opinion' can
take treatment choices out of the hands of treating physi-
cians when clinical discretion is restricted and out of the
hands of patients when treatment options are excluded
from guidelines. Preservation of treatment options is a
necessary underpinning to patient autonomy. Guideline
panels that fill in evidentiary gaps with 'expert opinion'
should be mindful of not interfering with medical deci-
sions that properly belong to the patient. Drawing the line
between paternalism and patient autonomy is a subtlety
that pervades medical care.
In a clinical setting, the patient can respond to unde-
sired paternalism by exercising 'voice or exit strategies'
[43]. Typically, the physician describes the choices and
recommends that the patient follow a particular treat-
ment approach. The patient can discuss concerns (voice)
and the physician may then modify the treatment recom-
mendation to reflect the patient's individual values [43].
Alternatively, if the physician does not offer treatment
options or if the patient does not improve under his care,
the patient can exercise his right to leave the relationship
(exit) and seek help elsewhere [43]. Either way, the physi-
cian is accountable and bears the consequences of his
actions, both legally and economically. In guidelines
development, there are no voice or exit approaches avail-
able to the patient. Hence, guidelines panels need to be
particularly reticent about interfering with treatment
choices or clinical discretion.
The boundary between treatment recommendations
that should be made by the panel and treatment options
that should be preserved for patients depends upon (1)
the quality of the evidence and (2) whether treatment
decisions involve trade-offs between risks and benefits
that depend on the values of the patient [44]. Because of
the lack of voice and exit options for patients in guideline
treatment recommendations, a high degree of certainty
should be required before interfering with patient choice
and clinical discretion. In his treatise on participatory
democracy and bioethics, Thomas May at the Medical
College of Wisconsin's Center for the Study of Bioethics
addressed the question of choice in the face of medical
uncertainty. He observed that 'there is no question that
amputation is the appropriate action in extreme cases of
gangrene' and concluded that the 'role of bioethics is pre-
cisely that of calling into question whether any treatment

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is appropriate without question' [45]. In the absence of
such certainty, May concluded that it is important to pre-
serve choice and to allow the individual whose life is most
affected by that choice, the patient, to exercise autonomy
of decision.
This comports with the American Medical Associa-
tion's code of ethics, which states: 'The principle of
patient autonomy requires that competent patients have
the opportunity to choose among medically indicated
treatments and to refuse any unwanted treatments' [46].
As May explained:
Determining 'appropriate' treatment, then, is itself a
determination that includes, among other things, a
value judgment. As we have seen, what is right for one
patient may not be right for another. Whether a given
treatment is appropriate depends on whether the
potential benefits of that treatment outweigh the bur-
dens it imposes on the patient. This judgment
requires that we consider the patient's perspective in
assessing the benefits and burdens of treatment. To
fail to do so is inconsistent with a liberal constitu-
tional society and with the rights of a patient in such a
society [45].
Ezekiel Emanuel, current advisor to President Obama,
explains why choice, autonomy, and informed consent are
central issues in medical ethics:
Most health policy analysts...see choice as essential
because individuals are the best judges of their own
interests. While individuals may not always be cor-
rect, they have more intimate knowledge of them-
selves, more reason to get it right, and more
motivation to be dogged in pursuit of their interests.
When choice is restricted or relegated to someone
else, there is a high chance that individuals will be
prevented from realizing their interests or their inter-
est will be sacrificed to someone else's interest. This
vie w is commonly cited by courts and others as one of
the justifications for informed consent [43].
Paternalism is generally rooted in the belief that one is
'right' and that intervention is necessary to protect the
patient from making a 'bad' decision. But, as David Buch-
anan at the Amherst School of Public Health and Health
Sciences, explains, good intentions do not justify interfer-
ence with personal liberty:
Dworkin defined paternalism as 'interference with a
person's liberty of action justified by reason referring
exclusively to the welfare. . .of the person being
coerced'. Paternalism is the usurpation of decision-
making power, by preventing people from doing what
they have decided, interfering in how they arrive at
their decisions or attempting to substitute one's judg-
ment for theirs. . .The moral concern is that the pre-
sumption that one is right, and therefore justified in
seeking to override other people's judgment, consti-
tutes treating them as less than moral equals [47].
With autonomy '[t]he critical point is being in the posi-
tion of deciding, not being decided for' [47]. As May
pointed out, the fact that an expert may disagree with the
patient is beside the point; autonomy only becomes a real
issue when an expert disagrees with the patient [45].
Hence, one of the essential tasks of a guidelines panel is to
identify and preserve 'choice' for the patient. Choice can
be preserved by acknowledging divergent viewpoints on
treatment, providing treatment options, or deferring to
clinical judgment. Guidelines of highly influential medi-
cal societies need to be crafted with care not to interfere
with patient choice.
When evidence is clear, well developed and uncon-
tested, the need to preserve choice is often not an issue.
However, it is essential that treatment choices be pre-
served when evidence is weak, mixed or not yet devel-
oped. As was noted in the discussion earlier, the lack of a
strong evidentiary base supports the decisive role of clini-
cal judgment exercised by the clinician rather than the
remote recommendations of a guidelines panel.
Beyond this, however, what should be done to preserve
legitimate treatment choice for the patient? Choice arises
out of a diversity of viewpoints. As Sniderman and Furb-
erg pointed out, '[b]ecause gaps in the evidence are inevi-
table, they must be filled in with judgments, and
judgments tend to preserve previous positions. Thus,
what is to be decided is often already decided with the
selection of the deciders' [4]. Hence, guidelines panel
constitution may well determine the range of treatment
options available to patients.
Hotly contested areas of medicine such as the 'Lyme
Wars' arise most often, as Atkins and colleagues noted in
Health Affairs, 'when evidence is weaker, outcomes are
less certain, and parties disagree about the risks of acting
in the face of uncertainty' [48]. The IOM addressed the
issue of guidelines panel constitution and concluded:
The inclusion of individuals with a range of relevant
professional and other backgrounds on guideline
development panels can help check financial, profes-
sional, and other sources of bias. . .[and] promote the
fuller consideration of potential outcomes, relevant
evidence, and aspects of implementation [25].
The concept of including a diverse panel is to ensure
diverse viewpoints--that is, to ensure that the interests of
different stakeholders are represented to the extent that
their interests are legitimate and central to the practice of
medicine. According to the IOM, 'clinical practice guide-
lines lie at the intersection of medical research, educa-
tion, and practice' [25]. It follows that researchers and
community physicians should be included on the panel.
Other stakeholders include patients, insurance providers
and pharmaceutical companies.
Most evidence-based guidelines panels are filled with
academic researchers rather than with community physi-
cians. In part, this represents a hegemonic shift away

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from commercially independent physicians who have tra-
ditionally controlled medicine, toward academic
researchers whose commercial funding as 'key opinion
leaders' may frame their viewpoints [49]. As Sniderman
and Furberg point out, however, this hegemonic shift may
merely transfer power from one authority based expert,
the physician, to another authority based expert, the
researcher [4]. Clearly researchers offer something of
value when they sit on guidelines panels, but their per-
spective is very different from that of the general practi-
tioner who on a daily basis sees patients who do not
conform to research populations and has first-hand expe-
rience with the heterogeneity of treatment response, the
need to preserve clinical judgment in guidelines, and the
importance of providing patients with treatment options.
Moreover, as was recognized during the AIDS activist
movement, there may be a 'clash between the canons of
research [which emphasize protection of research sub-
jects] and the canons of care [which emphasize availabil-
ity of treatment options]' [50].
As was noted earlier, the standard of care for physicians
is driven more and more by treatment guidelines. Before
the trend toward centralized medical decision-making
and evidence based guidelines, the standard of care was
largely determined by the 'consensus' of practicing physi-
cians. This consensus developed slowly over time and
reflected the practices of many physicians. Today recom-
mendations of a guidelines panel may serve as a proxy for
the consensus of treating physicians in determining and
driving the medical standard of care. In fact, '[f]or many
clinicians guidelines have become the final arbiters of
care' [4]. Thus, it is critical that guidelines not convey a
false sense of unanimity when none exists.
Guidelines need to elucidate rather than obscure seri-
ous debate regarding diagnosis and treatment since 'the
very nature of scientific debate is that no right answer has
emerged' [4,51]. The only way to assure this transparency
is through panel diversity reflecting the range of treat-
ment variation and practice. This means that diverse
viewpoints should be represented on guidelines panels,
that true voting of recommendations should occur to
determine the degree of consensus, and that legitimate
controversy should be acknowledged and reflected in the
guidelines text.
The other viewpoint that must be reflected in treat-
ment guidelines is that of the patient. The patient's view-
point is essential to preserve the 'choice' among medical
treatment options upon which the right to autonomy
rests. When legitimate treatment options are not
reflected in guidelines, autonomy has no meaning.
Patients may be represented by direct participation on
panels or by their treating physicians, and the value of
direct participation may vary depending on whether the
patient has become an 'expert' on the disease (as those
with chronic illnesses sometimes are) [52].
Direct participation on guidelines panels by 'expert'
patients is not common, but is growing. For example, the
Cochrane Consumer Network currently provides for
patient involvement [53]. The role of the consumer is to
'apply ethical principles such as human rights and civil
rights', 'comment on choice', identify 'potential conflicts
of interest' and to be 'vigilant to many possible sources of
bias' [53]. At the end of the day, the goal of patient repre-
sentation is to preserve the 'choice' and treatment flexibil-
ity that makes the exercise of autonomy meaningful.
Hence guidelines that recognize clinical judgment, pro-
vide treatment options, and safeguard the patient's right
to make treatment decisions can achieve this goal with-
out direct patient participation. However, the best way to
ensure that these issues are appropriately addressed is to
provide a seat at the table to those whose interests are at
stake: the patients.
A case study for abuse of the guidelines
development process
The process that IDSA used to develop Lyme treatment
guidelines exemplifies many of the issues found unac-
ceptable by commentators calling for reform of the guide-
lines development process, including uncontrolled
conflicts of interest by panel members, a paucity of evi-
dence, overreliance on the panel's 'expert opinion', the
exclusion of competing viewpoints, the failure to
acknowledge legitimate controversy, and the failure to
subject guidelines to broad external review or comment
[2]. The links between key issues in the broader debate
regarding guidelines and specific problems with the IDSA
Lyme guidelines are listed in Table 1.
Many of these issues were identified by Attorney Gen-
eral Blumenthal at the conclusion of his investigation,
when he found that:
• IDSA failed to conduct conflicts of interest reviews of
panel members with financial interests 'in drug compa-
nies, Lyme disease diagnostic tests, patents and consult-
ing arrangements with insurance companies'.
• Gary Wormser, MD, the chair of the panel, was
selected inappropriately, 'held a bias regarding the exis-
tence of chronic Lyme,' and 'handpick[ed] a like-minded
panel without scrutiny by or formal approval of the IDSA
oversight committee'.
• The IDSA Lyme disease panel refused to accept or
meaningfully consider information regarding the exis-
tence of chronic Lyme disease.
• IDSA blocked the appointment of scientists and phy-
sicians who had divergent views on chronic Lyme disease
who sought to serve on the 2006 guidelines panel by
informing them that the panel was fully staffed, even

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Table 1: Problems with IDSA Lyme Disease Guidelines
Weakness or Flaw IDSA Guidelines
Conflict of interest1Key panel members had financial interests related to Lyme disease patents, diagnostic
tests, pharmaceutical (vaccines) interests, and insurance consulting fees.2 Citation by panel
members of their own research was high (40%).
Overreliance on expert opinion138 of the 71 recommendations in the guidelines depend on the weakest Level III evidence,
namely 'expert opinion'.3
Artificial unanimity of recommendations1The panel excluded competing viewpoints voiced by community physicians and members
of its rival, ILADS.2
Specialty society self-publication1The guidelines were published in an IDSA journal and were not submitted to normal peer
review that would include divergent viewpoints. Letters to the editor critical of the
guidelines were not published.
Failure to acknowledge legitimate
controversy1
The controversy over Lyme disease was well known, but physicians with divergent
viewpoints were excluded from participation on the panel and the guidelines failed to
mention that other treatment approaches exist.2
Limitations on the exercise of clinical
judgment and failure to provide treatment
options4
The guidelines impose severe restrictions on the exercise of clinical judgment and fail to
provide treatment options despite a weak evidence base.
Academic researchers setting medical
protocols5
The IDSA panel consisted almost exclusively of academic researchers.6
NOTES
1. Sniderman AD, Furberg CD, Why Guideline-Making Requires Reform. JAMA 2009;301: 429-31.
2. Connecticut Attorney General's Office, 'Attorney General's Investigation Reveals Flawed Lyme Disease Guideline Process, IDSA Agrees to
Reassess Guidelines, Install Independent Arbiter,' press release, 1 May 2008, http://www.ct.gov/AG/cwp/view.asp?a=2795&q=414284.
(Accessed June 1, 2010)
3. Stricker RB, Johnson L, The Infectious Diseases Society of America Lyme Guidelines: Poster Child for Guidelines Reform. South Med J
2009;102: 565-6; Keller DM, 'Infectious Disease Treatment Guidelines Weakened By Paucity of Scientific Evidence,' Medscape Medical News,
13 November 2009, http://www.medscape.com/viewarticle/712341 (Accessed June 1, 2010)
4. American Association of Pediatrics (Steering Committee on Quality Improvement and Management), 'Classifying Recommendations for
Clinical Practice Guidelines,' Pediatrics 2004;114: 874-7.
5. Goozner M, 'IOM Urged to Recommend Conflict-Free Zone for Medicine,' http://www.cspinet.org/integrity/watch/200803101.html#3
(Accessed June 1, 2010)
6. Wormser GP, Dattwyler RJ, Shapiro ED, Halperin AJ, Steere AC, Klempner MS, Krause PJ, Bakken JS, Strle F, Stanek G, Bockenstedt L, Fish D,
Dumler JS, Nadelman, RB: The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and
Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2006;43: 1089-1134.
though the membership of the panel was later expanded
[2].
The conflicts of interest of the IDSA guidelines panel
members were significant and represent the type of ties
to industry and patents that are common to key academic
researchers in the field. According to the Connecticut
Attorney General:
The IDSA's 2006 Lyme disease guideline panel under-
cut its credibility by allowing individuals with finan-
cial interests - in drug companies, Lyme disease
diagnostic tests, patents and consulting arrangements
with insurance companies - to exclude divergent
medical evidence and opinion. In today's healthcare
system, clinical practice guidelines have tremendous
influence on the marketing of medical services and
products, insurance reimbursements and treatment
decisions. As a result, medical societies that publish
such guidelines have a legal and moral duty to use
exacting safeguards and scientific standards [2].
Wormser, who chaired the Lyme guidelines panel, dis-
puted the notion that financial interests could have
played a role in the development process: 'There's no
potential financial gain for generic drugs that are recom-
mended for short courses. It's inconceivable that anyone
would think so. To me it seems disingenuous to make
these allegations when they are so absurd' [54]. In Worm-
ser's view, because the panel members were not promot-
ing medications for treatment, there could be no conflict
of interest.
While conflict of interest abuses related to medications
used to treat diseases are well known, conflicts may
extend to any commercial area of medicine. As pointed
out in a previous forum [7], the IDSA Lyme guidelines
restrict the definition of the disease and mandate labora-

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tory testing. Guidelines that restrict the definition of a
disease can favor vaccine developers when they serve to
increase the reported rate of effectiveness for a vaccine.
Guidelines that mandate testing for diagnosis of a disease
promote the interests of those who hold patents on diag-
nostic tests. Guidelines that deny treatment to patients
further the financial interests of insurers and their con-
sultants. Attorney General Blumenthal found that the
IDSA Lyme guidelines panel had financial conflicts of
interest in each of these areas [2].
IDSA recommendations were presented as the unani-
mous consensus of those on the panel, yet the consensus
was achieved by excluding competing points of view and
giving voice to a panel that consisted almost exclusively of
academic researchers. That academic researchers on the
panel were empowered to dictate the practices of not only
IDSA members, but also the practices of family physi-
cians, general practitioners, and even competitors
throughout the nation -- physicians who were excluded
from the panel -- is one example of a hegemonic shift
away from clinicians to researchers. Given the exclusion
of community physicians from the panel, it is not surpris-
ing that the IDSA guidelines do not reflect the value of
preserving and deferring to the clinical judgment of the
treating physician in the face of scientific uncertainty.
The control of medical guidelines by academic
researchers is a problem not only because of the potential
for conflicts of interest, but also because one stakeholder
should not control medical guidelines that affect many
stakeholders. When scientific evidence is lacking or con-
tested, guidelines panels of dominant medical societies
should either include representation for all affected stake-
holders or should not constrain the rights of stakeholders
who are not on the panel by limiting treatment options
available to patients or creating legal consequences for
competitor physicians.
The IDSA guidelines failed to mention that there were
opposing points of view, let alone to reconcile conflicts
between its guidelines and the ILADS guidelines, as
required by the IDSA protocols for guideline develop-
ment [55]. Hence, unknowing physicians could read the
IDSA guidelines and be unaware that a controversy
exists. Moreover, the quality of evidence supporting the
guidelines was quite low, due in large measure to the state
of the emerging science; the few controlled treatment tri-
als that exist in Lyme disease have yielded conflicting
results and suffer from small sample sizes, poor research
design, and a lack of generalizability to the broader Lyme
patient population [9]. More than half of the recommen-
dations (38 of 71) in the IDSA Lyme guidelines are based
on Level III evidence--namely 'expert opinion'. (Table 1).
In the context of this poor evidence base, Wormser's
'handpick[ed] like-minded panel' filtered the evidence for
the guidelines, interpreted that evidence, and filled evi-
dentiary gaps with the 'expert opinion' of a panel that
excluded divergent viewpoints.
Unfortunately, the paucity of evidence noted in the
IDSA Lyme guidelines is not uncommon. At the IDSA
Annual Meeting in 2009, two independent presentations
described the low level of evidence used to support rec-
ommendations in IDSA guidelines across the board. Lee
and colleagues reviewed 30 guidelines published by IDSA
between 1994 and 2009, and found that 'more than half
were based on Level III evidence, which is from expert
opinion or not supported by properly controlled trials'.
Furthermore, the study found that only 14% of 'strong'
recommendations were based on appropriate Level I evi-
dence. These findings were corroborated by an indepen-
dent study presented by Khan and colleagues. The second
analysis noted that 55% of recommendations from 44
IDSA guidelines were supported only by 'expert opinion'
[56].
Notwithstanding these shortcomings, the dominance of
IDSA in the marketplace resulted in Lyme disease guide-
lines that could be treated as mandatory by insurers and
the legal system and foreclose treatment options for
healthcare consumers. As legal scholars have observed,
guidelines may either be used as a shield against liability
by those who comply with their protocols, or as a sword
against those who do not comply [57]. In the case of Lyme
disease, IDSA guidelines have been used as a sword
against physicians who do not conform to the IDSA pro-
tocols, notwithstanding the fact that these physicians
were excluded from the guidelines process[17]. This con-
tentious environment may have a chilling effect on the
willingness of physicians to treat patients with Lyme dis-
ease. In addition, insurers have relied on the guidelines to
deny coverage for non-compliant treatment approaches
and to force compliance from 'network' physicians[17].
When guidelines panels substitute their 'expert opinion'
for that of treating physicians and reduce treatment
options, the patient's right to autonomy -- to be able to
choose among treatment options -- is foreclosed, and
physicians who practice medicine using their best clinical
judgment may risk losing their medical licenses in mis-
conduct actions. The IDSA guidelines development pro-
cess created a situation rife with antitrust implications.
Even in the throes of the investigation, IDSA resorted
to questionable tactics involving 'copycat' Lyme guide-
lines published by the American Academy of Neurology
(AAN) and an article denying the existence of 'chronic
Lyme disease' that was published in the New England
Journal of Medicine [58,59]. Although these publications
appeared to provide 'independent corroboration' of the
restrictive IDSA viewpoint, closer scrutiny revealed that
the AAN and IDSA Lyme guidelines panels featured
overlapping members, including the chairmen of both
panels, and 11 members of the IDSA guidelines panel

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were authors of the article published in the New England
Journal of Medicine. There was no disclosure of the inher-
ent conflict of interest of using overlapping authorship in
independent publications to vindicate a guidelines panel
that was under investigation. Attorney General Blumen-
thal found that IDSA portrayed the AAN and IDSA Lyme
guidelines panels as 'independent,' even though 'the two
panels shared several authors, including the chairmen of
both groups, and were working on guidelines at the same
time' -- practices that violated the IDSA's own policy on
conflicts of interest [2].
The settlement
After 18 months of investigation, IDSA entered into a set-
tlement with the Connecticut Attorney General's office,
under which it agreed to reconstitute a guidelines panel
that would be free of conflicts of interest, consider all
submitted scientific evidence, and hold a public hearing
aired live over the internet [2]. The newly constituted
panel would make a determination whether each con-
tested recommendation 'is medically sound in light of all
of the evidence and information provided'. A determina-
tion to uphold a contested recommendation would
require a 75 percent supermajority vote of the panel
members. The details of the settlement and the Attorney
General's announcement are included as Additional Files
1 and 2 to this article.
Although these measures represented an improvement
over the IDSA development process for the 2006 Lyme
guidelines, they failed to accomplish the goal of a fair pro-
cess, as outlined below. A number of comments by two
former presidents of IDSA, Donald Poretz and Anne Ger-
shon, implied that IDSA viewed its obligations under the
settlement agreement with Attorney General Blumenthal
as being a process of merely 'going through the motions,'
and that the guidelines would remain unchanged [60-62].
Continuing concerns
Sniderman and Furberg argue that the developers of
treatment guidelines can become 'promoters and defend-
ers' of the guidelines produced under their auspices [4].
When an organization's guidelines are legally challenged -
- as they were here -- the validation of the guidelines may
become an overarching focus, and to do so quickly and
quietly to minimize damage in the press may become a
primary goal. Validation of the IDSA Lyme guidelines
would permit IDSA to continue to use them to limit com-
peting views of the disease, maintain IDSA's sphere of
influence, continue its domination in the marketplace,
and reduce potential litigation risk based on the guide-
lines. In short, the Lyme guidelines review process consti-
tuted a classic conflict of interest: IDSA's organizational
interests trumped its interest in maintaining the integrity
of the review process necessary to provide guidelines that
hold patient interests paramount.
The settlement outlined a process that was primarily
run by IDSA, which controlled many of the procedural
issues. Given what was at stake, would IDSA be able to set
aside its self-interest and decide the issues impartially?
As required under the settlement agreement, IDSA
held a public application process for the review panel.
Early on, patients questioned the appointment of two
panel members who had served on previous Lyme guide-
lines panels in derogation of the settlement agreement
requirements [63]. One panel member was removed after
intervention by the Attorney General, but the other
member remained on the panel [63]. The fact that IDSA
could have easily screened panelists for this requirement
and failed to do so with two panelists who had written
'IDSA friendly' guidelines in the past raised concerns
about IDSA's motivation to conduct a fair review process.
Potential panelists were screened for conflicts of inter-
est by an outside ethicist, Howard A. Brody, Director of
the Institute for Medical Humanities at the University of
Texas Medical Branch in Galveston. The fact that an ethi-
cist screened panel members for potential conflicts of
interest does not mean that these conflicts were removed
from the process. For one thing, Brody, who was paid by
the IDSA for his services, surprisingly excluded from the
panel any physician who earned more than $10,000 per
year from treating Lyme disease [63]. The primary inter-
est of patient guidelines is to provide improved patient
treatment outcomes, and it is difficult to see how physi-
cians who treat patients on a fee-for-service basis would
have a secondary competing interest. Moreover, because
most physicians who treat Lyme disease specialize in its
treatment and earn more than $10,000 per year doing so,
application of this standard alone eliminated the diver-
gent viewpoints of IDSA competitors, allowing IDSA to
continue 'sitting in judgment of its competitors', and
making it less likely that legitimate controversy would be
acknowledged or that patient choice among treatment
options would be preserved.
Since medical specialty societies represent their own
membership base, should they not be allowed to exclude
from the panel the viewpoints of patients and community
physicians who hold divergent views? Whether this is
legally permissible under antitrust law may depend in
part on whether the medical society has sufficient influ-
ence and power to constrain consumer choice and harm
competitors. Even assuming a medical society wields
enormous influence, it can elect to acknowledge legiti-
mate controversy, provide for treatment options, and
defer to the clinical judgment of the treating physician
when the evidence base is weak.

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This is an area where the primary interest of patient
care may be at odds with the secondary interest of spe-
cialty medical societies in protecting territorial turf and
hegemonic dominance over non-specialists. In short, this
may represent a conflict of interest for the medical spe-
cialty society. The IOM suggested that institutions have
separate committees with members from outside the
organization to recognize and manage institutional con-
flicts of interests [25].
The IDSA review panel consisted largely of IDSA mem-
bers who could give precedence to the reputational inter-
ests of their medical society or take on the mantle of
being defenders of their society's guidelines. Using the
IOM's primary/secondary analysis of conflicts, this con-
stituted a classic conflict of interest. The review panel in
turn determined who the presenters at the hearing would
be and excluded a physician who authored more than
40% of the ILADS evidentiary submission from present-
ing at the hearing. The panel also limited the duration of
the hearing to one day rather than using the traditional
two day hearing process for guidelines [64]. The short
hearing was particularly disturbing given the complexity
of the issues presented.
On July 30, 2009, the panel heard presentations from
those opposing and those supporting the IDSA guide-
lines. Evidence submitted to the panel by ILADS included
more than 300 pages of analysis and roughly 1,300 peer-
reviewed research studies opposing the recommenda-
tions in the IDSA guidelines [65]. The panel initially said
it would have a decision by the end of 2009, but that
deadline was delayed.
On February 1, 2010, the Connecticut Attorney Gen-
eral, who was monitoring the panel review process, sent a
letter to IDSA that expressed concern over an improper
voting procedure adopted by the panel [66]. The proce-
dure used by the panelists essentially flipped a superma-
jority voting requirement to make revision of the
guidelines less likely. For example, according to the letter
by the Attorney General, the panel's vote on whether lab-
oratory tests, which ILADS contends are flawed, should
be required for a diagnosis of Lyme disease was dead-
locked at 4 to 4, indicating that there was no consensus
even on a panel that excluded divergent viewpoints [67].
However, the IDSA panel employed different voting
requirements and initially concluded that this vote meant
that the guidelines did not require revision. According to
the Attorney General, the IDSA panel not only violated
the voting procedure stipulated in the settlement agree-
ment, it also failed to comply with an internal IDSA
memo directing the panel on the proper procedure for
voting [67]. A copy of the letter from the Attorney Gen-
eral to IDSA and a copy of the internal memo from IDSA
to the panel are included as Additional Files 3 and 4 to
this article.
On April 22, 2010, the IDSA review panel released its
report [68]. Despite the voluminous testimony presented
by ILADS, the panel voted almost unanimously to uphold
the guidelines without exception. Carol Baker, the panel
chair and former president of IDSA, stated that for 69
guideline recommendations the panel found that each
was "medically and scientifically justified in light of all the
evidence and information and required no revision." The
panel report expressed concern that prolonged use of
antibiotics puts patients in danger of serious infection
while not improving their condition. The report stated:
"In the case of Lyme disease, there has yet to be a single
high-quality clinical study that demonstrates benefit to
prolonging antibiotic therapy beyond one month." As to
the existence of a chronic persistent form of Lyme dis-
ease, the panel concluded that "symptoms that are com-
monly attributed to chronic or persistent Lyme, such as
arthralgias, fatigue and cognitive dysfunction, are seen in
many other clinical conditions and are, in fact, common
in the general population. It would thus be clinically
imprudent to make the diagnosis of Lyme disease using
these nonspecific findings alone [68]".
To deal with the testing issue where the panel vote was
split, the final report concluded that testing was not a
true recommendation and therefore did not fall within
the parameters of the settlement agreement [68]. The
guideline language at issue states: "Diagnostic testing per-
formed in laboratories with excellent quality-control pro-
cedures is required for confirmation of extracutaneous
Lyme disease." Hence, although the panel originally voted
on the testing recommendation with a split vote, when
pressed to redo the vote in conformity with the agree-
ment, the panel recharacterized the testing requirement
as a "statement" that did not constitute a recommenda-
tion. This seemingly transparent attempt to manipulate
the vote to ensure a desired outcome, coupled with the
exclusion of divergent viewpoints and other process
irregularities, show how easy it is for political consider-
ations, such as avoiding legal liability or protecting orga-
nizational reputation, to trump impartial scientific
review. The Attorney General's office has announced that
it will "carefully and comprehensively assess the final
report and the review process leading to that report to
determine whether the IDSA fulfilled the requirements of
our settlement [69]".
Future considerations
As guidelines play a more central role in managed health
care, the issue of fundamental fairness in the develop-
ment process will be pivotally important, and additional
challenges to medical guidelines will arise, particularly
where conflicts of interest exist. The integrity of the
review process may depend upon whether it is realistic to
expect institutional conflicts of interest and impartiality

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of the process to be effectively managed within the orga-
nization whose guidelines are challenged, or whether
greater safeguards are necessary. The IDSA review panel
process may provide those who subsequently embark on
a guideline review process with valuable lessons on pro-
cess integrity issues that should be addressed.
Alternate conflict resolution approaches might have
been more fruitful. Independent oversight through a pri-
vate conflict resolution advisor may have resolved many
of the issues that have arisen. One alternative approach
would have been a review conducted by a government
agency such as the National Institutes of Health (NIH),
which sponsors consensus conferences. However, the
NIH has been criticized for its management of both intra-
mural and extramural conflicts of interest in the past [70-
72]. Moreover, the relationship between the NIH and
IDSA has been close, and IDSA panel members have
received a number of NIH grants. In addition, IDSA
opposed the adoption of conflict of interest rules for the
NIH [72]. Hence, the NIH's ability to act as a neutral arbi-
ter for these types of issues is unclear.
In medicine, professional societies have generally been
free to pursue the agendas of their members without con-
sidering the impact on competitors or patients. With the
increasing importance of guidelines in the environment
of universal health care, it can be expected that antitrust
laws will become an important factor in guideline devel-
opment. Antitrust implications may not be relevant when
the issues at hand are not controversial or the society
considering the guidelines is not considered dominant
under antitrust laws. However, when dominant medical
societies develop guidelines that are adopted as the stan-
dard of care and are used to foreclose treatment options
for patients, a different approach is necessary to skirt
antitrust scrutiny. Perhaps the best lessons can be learned
from the practices of trade associations, typically com-
prised of competing members of an industry, that have
developed considerable experience complying with the
due process requirements of antitrust laws.
One of the foremost standard setting organizations is
the American National Standards Institute (ANSI). ANSI
employs a standard-setting process that provides due
process, which it defines as follows:
Due process means that any person (organization,
company, government agency, individual, etc) with a
direct and material interest has a right to participate
by a) expressing a position and its basis, b) having that
position considered, and c) having the right to appeal.
Due process allows for equity and fair play [73].
ANSI due process guidelines provide that the minimum
acceptable due process requirements for the development
of consensus include openness, lack of dominance, bal-
ance, consideration of view and objections, and a
supermajority consensus voting requirement [73]. Open-
ness requires that participation must be open to all
affected persons and that it may not be conditional on
membership in an organization. Lack of dominance
requires that the process not be dominated by any single
interest category or organization. ANSI defines domi-
nance as 'a position or exercise of dominant authority,
leadership, or influence by reason of superior leverage,
strength, or representation to the exclusion of fair and
equitable consideration of other viewpoints' [71]. Balance
requires a balance of interest from diverse interest cate-
gories and does not permit any single interest category to
constitute more than one third of the membership of the
consensus body. Interest categories include producers,
providers and consumers. ANSI protocols require that
standard setting organizations record and consider all
negative votes accompanied by comments related to the
proposal under consideration. Finally, people who are
adversely affected by standards developed by ANSI are
entitled to appeal.
How would a medical guideline development process
developed under ANSI guidelines look? First, the panel
would include researchers, community physicians and
patients, and none of the participants would need to be
members of the medical society. Second, the members of
the medical society would not be permitted to dominate
the process and could constitute no more than 33% of the
panel. Similarly, academic researchers could occupy no
more than 33% of the panel. Third, divergent opinion, in
the form of negative votes with comments would be
recorded and considered. Fourth, votes would require a
two-thirds supermajority and decisions would be subject
to appeal. Had these requirements been in place when the
IDSA panel developed its Lyme guidelines, antitrust
issues would not have arisen. Further, had ANSI guide-
lines been used as a model for the review process, the
panel would have been balanced with physicians from
ILADS and IDSA, researchers, clinicians and patients.
Conclusions
Attorney General Blumenthal's investigation 'exposed a
deeply flawed process rife with conflicts of interest that
improperly excluded alternative views and information'
[63]. The application of antitrust law was based on IDSA's
dominant position in the marketplace and the foreclosure
of treatment options for healthcare consumers. IDSA's
response to the guidelines investigation reaffirmed the
need for Attorney General Blumenthal to apply antitrust
law to insure procedural fairness.
The recent calls for guidelines reform dovetailed with
the issues giving rise to the IDSA antitrust investigation.
Medical societies have an obligation to acknowledge
legitimate controversy in treatment approaches, particu-
larly when the controversy is fueled by a paucity of high-
quality evidence. At a minimum, the guidelines issued by

Johnson and Stricker Philosophy, Ethics, and Humanities in Medicine 2010, 5:9
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a dominant medical society should conform to funda-
mental rules of due process, fairness, and accuracy. It is
critical that the interests of all stakeholders be given a
voice, that legitimate controversies be acknowledged, and
that treatment options be preserved. The application of
antitrust law may provide a much-needed vehicle of
reform to prevent future abuses.
As we have argued elsewhere, the exclusion of compet-
ing evidence in treatment guidelines is clinically and ethi-
cally unacceptable [74,75]. Failure to disclose treatment
options violates the principles of patient autonomy and
informed consent, which require that treatment options
should be disclosed to patients and that treatment deci-
sions should be made with the patient's informed consent
[76]. Treatment guidelines should not inhibit patient
access to treatment options; rather, guidelines should
describe treatment options and default to the clinical
judgment of treating physicians in order to maximize the
ability of patients to get well.
Additional material
Competing interests
The authors serve on the board of directors of CALDA and ILADS, although this
article has been written in their individual, rather than organizational capaci-
ties. In addition, both authors presented testimony before the IDSA Lyme
guidelines review panel.
Authors' contributions
LJ participated in the conceptualization of the study, performed the research,
wrote the initial draft and participated in subsequent rewrites of the manu-
script. RBS participated in the conceptualization of the study and participated
in subsequent rewrites of the manuscript. Both authors have read and
approved the final manuscript.
Acknowledgements
The authors thank Dr. Elizabeth Maloney, Richard Wolfram, Kris Newby, Miguel
Perez-Lizano, and Barbara Blossom for helpful discussion. RBS serves without
compensation on the medical advisory panel of QMedRx, Inc. He has no finan-
cial ties to the company. There is no funding source for this article.
Author Details
1California Lyme Disease Association, Ukiah, CA, USA and 2International Lyme
and Associated Diseases Society, Bethesda, MD, USA
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Received: 28 January 2010 Accepted: 9 June 2010
Published: 9 June 2010
This article is available from: http://www.peh-med.com/content/5/1/9© 2010 Johnson and Stricker; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Philosophy, Ethics, and Humanities in Medicine 2010, 5:9

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doi: 10.1186/1747-5341-5-9
Cite this article as: Johnson and Stricker, The Infectious Diseases Society of
America Lyme guidelines: a cautionary tale about the development of clini-
cal practice guidelines Philosophy, Ethics, and Humanities in Medicine 2010, 5:9