Pharmacovigilence and the Plight of Chronic Pain Patients: In Pursuit of a Realistic and Responsible Ethic of Care


PHARMACOVIGILENCE AND THE PLIGHT OF CHRONIC

PAIN PATIENTS: IN PURSUIT OF A REALISTIC AND

RESPONSIBLE ETHIC OF CARE

Daniel S. Goldberg* and Ben Rich**

I. INTRODUCTION..................................... 84

II. THE CONVERGENCE OF TWO PERFECT STORMS .... ..... 86
III. OPIOID CONTRACTS AND THE STANDARD OF CARE FOR

CHRONIC OPIOID THERAPY ............ .............. 88
IV. COMPETING MODELS OF THE PHYSICIAN-PATIENT

RELATIONSHIP .............................. ...... 90

V. A BRIEF HISTORY OF THE USE OF PHYSICIAN-PATIENT

CONTRACTS ................................. ...... 93

VI. INFORMED CONSENT ......................... ...... 97
A. Elements of Informed Consent as They Relate to Pain

Management........................... 98
B. Important Considerations in the Process of Informed

Consent for Pain Therapy.......... .......... 100
VII. OPIOID CONTRACTS IN THE MANAGEMENT OF CHRONIC

PAIN ............................. ............. 102

VIII. THE UNIVERSAL PRECAUTIONS APPROACH.................. 104

IX. ADHERENCE MONITORING THROUGH URINE DRUG

SCREENING IN OPIOID THERAPY .................... 108
X. CHRONIC PAIN, STIGMA, AND OPIOID CONTRACTS: A

POPULATION-LEVEL BIOETHICS ANALYSIS ...... ....... 109

XI. CONCLUSION .............................. ...... 120

* Daniel S. Goldberg, Assistant Professor, The Brody School of
Medicine, East Carolina University; J.D., University of Houston Law
Center; Ph.D., Medical Humanities, Institute for Medical Humanities,
University of Texas Medical Branch.

.. Ben Rich, Professor and School of Medicine Alumni Association
Endowed Chair of Bioethics, University of California, Davis; J.D.,
Washington University in Saint Louis School of Law; M.A. & Ph.D.,
University of Colorado, Boulder.



INDIANA HEALTH LAW REVIEW

I. INTRODUCTION

In this paper, we critique the increasingly prevalent
approach in pain management that urges the universal
adoption of medication adherence contracts (so-called
"opioid contracts") and random urine drugs screening as
tools for managing the risk involved in prescribing and
consuming opioid analgesics. Although the use of such
opioid contracts and drug screening has received some
recent attention in the bioethics literature, in this paper we
advance new lines of criticism. We develop these criticisms
in context of the use of opioid contracts through both dyadic
and population-level perspectives, a combination of
approaches that have rarely been deployed simultaneously
in the bioethics literature on the undertreatment of pain.
In the first portion of the paper, we criticize the turn to
opioid contracts through analysis of the physician-patient
relationship. We discuss several models of the relationship,
and document the infirmities of a contractual model, which
underpins the justification for opioid contracts. We move on
to enumerate the essential elements of informed consent in
context of the care of patients with chronic pain, and argue
that properly understood, applied, and documented,
scrupulous adherence to informed consent offers all of the
benefits and none of the burdens of opioid contracts. We
conclude the first segment of our paper by describing the
"universal precautions" approach to opioid therapy that has
been highly touted in recent years, and in the process
identify our particular concerns with regard to it.

The second portion of the paper balances the prior
emphasis on the therapeutic dyad with a macrosocial
approach leveraging techniques drawn primarily from
population-level bioethics. The focus here is on the
likelihood that widespread utilization of opioid contracts
will intensify the stigmatization of chronic pain sufferers,
an already highly-stigmatized group that is in turn
disproportionately composed of other disadvantaged and
stigmatized social groups. Here, we define and
operationalize disease stigma, explain why it is a pressing
population-level bioethics issue on both descriptive and

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normative grounds, and show how the use of opioid
contracts as part of a universal precautions approach is
much more likely to intensify than to ameliorate stigma,
contrary to the claims of its proponents. We apply Powers
and Faden's sufficientarian account of social justice as a
way of grounding the normative claim that the
intensification of stigma is ethically unacceptable because it
is both independently associated with adverse health
outcomes and because it constitutes a particularly
pernicious form of social disadvantage that is
disproportionately likely to impact already marginalized
groups.

Before proceeding to the argument, it is important to
note two caveats. First, we wish to emphasize our belief
that one of the primary obstacles to ameliorating the
devastating and inequitable undertreatment of pain in the
United States is the conflation of this problem with the
problem of safe and effective utilization of opioids. Of
course, both the undertreatment of pain and the safe and
effective utilization of opioids are public health problems.
However, there are profound clinical, empirical, and
conceptual reasons to doubt that even the achievement of a
reasonable opioid regulatory regime will substantially
improve the undertreatment of pain in the United States.
As we have documented these claims and the rationale for
them elsewhere, we mention it here only to contextualize
our present objectives, which are indeed focused on the use
of opioids in the treatment of chronic noncancer pain.'
Notwithstanding our focus in this article, nothing argued
herein should be taken as contrary to our belief that the
undertreatment of pain and the safe and effective use of
opioids are distinct public health problems, and that
conflating them is a serious mistake. Second, for purposes
of this article, we wish to focus on a particular category of
pain and a very specific aspect of treating it. Our special
concern and focus will be patients with moderate to severe

1 Daniel S. Goldberg, Job and the Stigmatization of Chronic Pain,
53 PERSP. BIOLOGY MED. 425 (2010); Daniel S. Goldberg, On the
Erroneous Conflation of Opiophobia and the Undertreatment of Pain, 10
AM. J. BIOETHICS, no. 11, 2010, at 20.

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chronic noncancer pain and whether the prevailing
standard of care for prescribing opioid analgesics requires
the use of a formal, written opioid contract that includes a
provision for random urine drug screens, as a condition
precedent for providing such therapy to any patient.

We begin the substantive analysis by delving into some
of the social and political context regarding the rise of opioid
contracts and the undertreatment of pain.

II. THE CONVERGENCE OF Two PERFECT STORMS

Beginning in earnest in the early 1990s, governmental
agencies and health professional organizations
acknowledged increasing evidence of pervasive
undertreatment of pain. One early response to this
phenomenon was the convening of interdisciplinary panels
of experts by the Agency for Health Care Policy and
Research and the promulgation of two extensive Clinical
Practice Guidelines. 2 Eventually undertreated pain of all
types came to be recognized as having reached epidemic
proportions and a becoming a world-wide public health
problem. 3  The normative dimension of tolerating the
unnecessary affliction of so many prompted advocates to
demand recognition of pain management as a fundamental
human right.4 Still more recently, the Institute of Medicine
("IOM") report Relieving Pain in America characterizes

2 AGENCY FOR HEALTH CARE POLICY AND RESEARCH, U.S. DEP'T OF
HEALTH AND HUMAN SERVS., CLINICAL PRACTICE GUIDELINE (No. 1):
ACUTE PAIN MANAGEMENT: OPERATIVE OR MEDICAL PROCEDURES AND
TRAUMA (1992); AGENCY FOR HEALTH CARE POLICY AND RESEARCH, U.S.
DEP'T OF HEALTH AND HUMAN SERVS., CLINICAL PRACTICE GUIDELINE
(No. 9): MANAGEMENT OF CANCER PAIN (1994); World Health
Organization [WHO], Access to Controlled Medications Programme,
Improving Access to Medications Controlled Under International Drug
Conventions (Feb. 2009), available athttp://www.who.int/medicines/
areas/quality-safety/ACMPBrNoteGenrlENFeb09.pdf.

3 See WHO, supra note 2.
4 See Frank Brennan et al., Pain Management: A Fundamental

Human Right, 105 ANESTHESIA & ANALGESIA 205, 211 (2007).

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effective pain management as a "moral imperative" and a
"professional responsibility."5

Between the mid-1990s and the present, data strongly
indicate that in the United States there has been an
exponential increase in the retail sales of opioid analgesics,
a main line form of treatment for moderate to severe pain.6

During roughly the same period deaths associated with the
ingestion of opioids dramatically increased as well-142%
increase between 1999 and 2004.7 There are also an
increasing number of articles in the medical literature
calling into serious question the safety and efficacy of
opioids for the management of chronic pain over prolonged
periods of time.8 However, there is a post hoc ergo propter
hoc quality to some declarations that the pendulum has now
swung too far away from the era of rampant opiophobia to
the present when physicians allegedly are with reckless
abandon prescribing opioids to anyone who complains of
pain.9 Such pronouncements fail to take account of the
many potential sources, other than prescriptions written for
pain patients, by which those who abuse or are addicted to
drugs may obtain these medications. 10

Moreover, data indicate that both in the United States
and worldwide we are a very long way from winning the

5 INST. OF MEDICINE, RELIEVING PAIN IN AMERICA: A BLUEPRINT

FOR TRANSFORMING PREVENTION, CARE, EDUCATION, AND RESEARCH 3
(2011), available at http://books.nap.edu/openbook.php?recordid=
13172.

6 See Dennis C. Turk et al., Treatment of Chronic Non-Cancer
Pain, 377 LANCET 2226, 2227 (2011).

7 See Jane C. Maxwell, The Prescription Drug Epidemic in the
United States: A Perfect Storm, 30 DRUG & ALCOHOL REV. 264 (2011).

8 See Paul F. White & Henrik Kehlet, Improving Pain
Management: Are we Jumping From the Frying Pan into the Fire? 105
ANESTHESIA & ANALGESIA 10, 11 (2007).

9 See Jane C. Ballantyne & Naomi S. Shin, Efficacy of Opioids for
Chronic Pain: A Review of the Evidence, 24 CLINICAL J. PAIN 469, 469
(2008).

10 See HUMAN RIGHTS WATCH, GLOBAL STATE OF PAIN TREATMENT:

ACCESS TO MEDICINES AND PALLIATIVE CARE (2011), available at
http://www.hrw.org/sites/default/files/reportshhr051 1W.pdf.

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still formally undeclared "War on Pain."" At the same
time, the long-standing "War on Drugs" is shifting so as to
accommodate a focus on the exponential increase in the
abuse of prescription drugs. In a sincere effort by leaders in
the pain medicine community to demonstrate an awareness
of and appropriate concern for the recent epidemic of
prescription drug abuse, the policy mantra has become one
of balance, epitomized by the shared goals of insuring that
pain patients receive the medications they require while at
the same time minimizing the risk that such prescriptions
will be abused or be diverted to others with no medical need
for them. 12 One of our special concerns is that the mantra
of balance has not been restricted to the policy realm of
state and federal laws and regulatory policies. Recently it
has come to be viewed by some thought leaders as an
essential component of "pharmacovigilence," or responsible
opioid prescribing, and thereby required in order to practice
consistent with the minimal standard of acceptable care.
This move, we believe, presages a dramatic shift in the
ethos of medicine and the fiduciary nature of the physician-
patient relationship. To these concerns we now turn.

III. OPIOID CONTRACTS AND THE STANDARD OF CARE FOR
CHRONIC OPIOID THERAPY

In a recent commentary by three prominent pain
medicine specialists, the authors noted that in 2010 an
expert multidisciplinary panel commissioned by the
Department of Defense ("DoD") and the Veterans Health
Administration ("VHA") had completed a two-year
systematic review of existing medical literature in the field
of pain management and concluded that "opioid treatment
agreements are a standard of care when prescribing chronic

11 See David E. Joranson & Aaron M. Gilson, A Much-Needed
Window on Opioid Diversion, 8 PAIN MED. 128 (2007).

12 PAIN & POLICY STUDIEs GRP., UNIV. OF WIs., ACHIEVING
BALANCE IN STATE PAIN POLICY - A PROGRESS REPORT CARD (4th ed.)
(2008).

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opioid therapy."13 Since the comprehensive clinical practice
guideline implemented by the VHA recommend that such
agreements should be obtained from all VHA patients prior
to the initiation of opioid therapy, and that such agreements
shall contain a provision whereby the patient consents to
periodic unscheduled drug screens, we interpret the above
quoted language as an assertion that the currently
prevailing national standard of care requires a formal opioid
contract and random urine drug screens for all patients
undergoing opioid analgesia.14 We note, however, that the
VA/DoD guideline does not preclude initiation of opioid
therapy if a patient refuses to execute an opioid agreement.
Rather, it provides that "[platient refusal to sign an
agreement should be documented in the medical record" and
considered "part of the initial and ongoing assessments of
the patient's ability to adhere to the treatment plan and
level of risk for adverse outcomes."15

We shall presume that included in the VHA/DoD review
of the medical literature were the Federation of State
Medical Boards Model Policy for the Use of Controlled
Substances for the Treatment of Pain, the expanded
articulation of this model policy in a guidebook for clinicians
under the title Responsible Opioid Prescribing, and the
American Pain Society/American Academy of Pain Medicine
Clinical Guidelines for the Use of Chronic Opioid Therapy
in Chronic Noncancer Pain.16 However, none of these
publications supports the position that the minimal

13 Scott M. Fishman et al., The Opioid Agreement: A Real-World
Perspective, 10 AM J. BIOETHICS no. 11, 2010, at 14.

14 VETERANS ADMIN. & DEP'T OF DEF., CLINICAL PRACTICE
GUIDELINE FOR MANAGEMENT OF OPIOID THERAPY FOR CHRONIC PAIN 31-
34 (2010), available at http://www.healthquality.va.gov/COT_312_Full-
er.pdf.

15 Id. at 32-33.
16 See MODEL POLICY FOR THE USE OF CONTROLLED SUBSTANCES

FOR THE TREATMENT OF PAIN (2004) (Fed'n of State Med. Bds.), available
at http://www.fsmb.org/pdf/2004_grpolControlledSubstances.pdf', Scott
M. Fishman, RESPONSIBLE OPIOID PRESCRIBING: A PHYSICIAN'S GUIDE
(2009); Roger Chou et.al, Clinical Guidelines for the Use of Chronic
Opioid Therapy in Chronic Noncancer Pain, 10 J. PAIN 113 (2009),
available at http://download.journals.elsevierhealth.com/pdfs/journals/
1526-5900/PIIS1526590008008316.pdf.

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standard of acceptable care for chronic opioid therapy
requires a formal, written opioid agreement and random
urine drug screens for all patients as a kind of "universal
precaution." On the contrary, their consistent
recommendation is that physicians should use their clinical
knowledge, skills, and judgment in order to assess whether
the patient presents an increased level of risk that would
warrant the use of an opioid agreement. From this
perspective, the insistence of some clinicians that opioid
agreements and random urine drug screening should be a
''universal precaution" might reasonably be interpreted as
an abdication of one's professional responsibility to make
such an assessment and utilize it as a basis upon which to
determine whether a formal written contract and random
urine drug screening is warranted. Further exploration of
this possibility requires a brief discussion of the foundations
for that responsibility.

IV. COMPETING MODELS OF THE PHYSICIAN-PATIENT
RELATIONSHIP

A detailed discussion of the extensive literature
comparing, contrasting, and evaluating various models of
the physician-patient relationship is beyond the scope of
this article. However, a more focused consideration of two
of these-the contractual and the covenantal-are
particularly relevant to the legitimate role, if any, of formal
written agreements between physician and patient in
certain clinical situations. One particularly influential
analysis offered by Robert Veatch sought to distinguish
among four possible models: (1) the Priestly (paternalism),
(2) the Engineering (physician as technician), (3) the
Collegial (physician and patient as fully equal parties), and
(4) the Contractual.1 7 According to Veatch only the contract
model could stand up to rigorous critical analysis at least in
part because it appears to be consistent with the shared

17 Robert M. Veatch, Models for Ethical Medicine in a
Revolutionary Age: What Physician-Patient Roles Foster the Most
Ethical Relationship, 2 HASTINGS CENTER REP. 5 (1972).

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decision-making antidote to paternalism that respect for
patient autonomy seemed to require.

Other prominent commentators seriously question the
adequacy of a contractual model to exemplify not merely the
fiduciary nature of the physician-patient relationship, in
particular the physician's virtually unqualified professional
responsibility to pursue the best interests of the patient and
to recognize the patient's exquisite vulnerability in the face
of illness.18 At least since the Hippocratic era, those who
enter the medical profession swear an oath to direct their
professional energies toward the restoration and
maintenance of the health of their patients above all else.
The very nature of this oath conveys the strong sense of a
covenantal relationship as the defining nature of the
therapeutic dyad. The imbalance of knowledge and power is
the central feature of any fiduciary relationship. This
intrinsic imbalance is inconsistent with the contractual
paradigm of an agreement between relatively equal parties
mutually endorsing fully and freely negotiated terms.
Unequal parties do regularly enter into contracts, but the
result is often regarded in law as a "contract of adhesion," a
term of art denoting that the contract is a standard form
drafted by and reflecting the interests of the stronger party
which the weaker party must accept or reject "as is" with no
opportunity for meaningful negotiation. 19

Furthermore, in 1995 eight prominent physicians
published a brief but cogent thought piece entitled "Patient-
Physician Covenant."20 The thrust of the piece is captured
in the following passage:

Medicine is, at its center, a moral enterprise
grounded in a covenant of trust. . . .
Physicians, therefore, are both intellectually

18 See, e.g., EDMUND D. PELLEGRINO & DAVID C. THOMASMA, A
PHILOSOPHICAL BASIS OF MEDICAL PRACTICE (1981); WM. F. MAY, THE
PHYSICIAN'S COVENANT: IMAGES OF THE HEALER IN MEDICAL ETHICS (2d
ed. 2000).

19 See, e.g., A.R. Holder, What Is a Contract of Adhesion? 13 IRB:
ETHICS & HUM. SUBJECTS RES. 10 (1991).

20 R. Crawshaw et al., Patient-Physician Covenant, 273 JAMA
1553 (1995).

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and morally obliged to act as advocates for the
sick wherever their welfare is threatened and
for their health at all times... . Only by caring
and advocating for the patient can the
integrity of our profession be affirmed. Thus
we honor our covenant of trust with patients. 21

The responsibility of the physician to take on an advocacy
role to ensure that the patient's needs for necessary or
medically indicated treatment has been recognized by
medical-legal commentators and medical organizations. 22

Recognition of this professional responsibility reinforces the
proposition that the pursuit of the patient's medical needs
supersedes concerns about broader societal issues in the
absence of any clear indication that the patient's conduct
may imperil his/her own health as well as pose a threat to
others.

Finally, in a recent special issue of the American Journal
of Bioethics devoted to the issue of opioid contracts for
chronic pain management, one commentator wrote of "the
physician's covenant with the patient in pain."23 Invoking
May's conceptual analysis of the physician's covenantal
relationship with the patient, the author argues:

If physicians wish to remain true
professionals, and not merely replaceable
technician-cogs in the machinery of modern
industrialized medicine, then physicians must
strive to treat the patient as a covenantal
partner rather than a consumer subject to a
contract. . . . As a tool to help reinforce that
relational expectation, a written memorandum
from physician to patient, adjusted to the

21 Id.
22 See, e.g., Wi. Sage, Physicians as Advocates, 35 HouS. L. REV.

1529 (1999); accord AMERICAN ACADEMY OF PAIN MEDICINE, ETHICS
CHARTER (2008), available at http://www.painmed.org/files/ethics-
charter.pdf.

23 Robert L. Fine, The Physician's Covenant with Patients in Pain,
10 AM. J. BIOETHICS 23 (2010).

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patient's medical literacy, is certainly ethically
appropriate and may be practically useful.
However, having the patient sign the
memorandum as a contract is neither.24

Despite ongoing expression of concerns, there has been
qualified support for adopting a contractual approach to at
least certain aspects of patient care. It is important to
consider the nature and limitations of that support before
moving into a more targeted consideration of the ethical and
legal dimensions and implications of opioid contracts.

V. A BRIEF HISTORY OF THE USE OF PHYSICIAN-PATIENT
CONTRACTS

Formal written contracts between physicians and
patients, as documents separate and distinct from the usual
and customary consent forms, are uncommon in most areas
of clinical practice. Proponents of the use of such contracts
in certain patient care situations often cite an early article
that makes the case for a contractual approach as
promoting "partnerships in patient care."25  Such a
contractual approach, the author of that article maintains,
is based on four assumptions: 1) both physician and patient
have unique responsibilities in the relationship; 2) the
relationship itself is voluntary and consensual, not
obligatory; 3) both physician and patient must be willing to
compromise in negotiating the terms of the contract; and 4)
both parties must find benefit in the relationship that are
reflected in the terms and conditions of the contract. 26

Curiously, there is no discussion in the article about the
doctrine of informed consent, the concept of shared decision
making, or the relationship between those and a contractual
model of the physician-patient relationship. There are
several interesting aspects of the article that bear upon the
specific phenomenon of opioid contracts. One is that the

24 Id.
25 Timothy E. Quill, Partnerships in Patient Care: A Contractual

Approach, 98 ANNALS INTERNAL MED. 228 (1983).
26 Id.

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typical opioid contract in use today is not the result of a
negotiation between the physician and a particular patient,
but rather a boilerplate form to which all patients must
subscribe in order to receive opioid therapy, in other words,
the quintessential contract of adhesion. Second, among the
clinical vignettes discussed by Quill, the very first involves
a patient undergoing long-term opioid therapy for chronic
noncancer pain.27

One medical specialty that, even before the Quill article,
had embraced the use of contracts is psychiatry, at least for
patients who were deemed to pose a risk of suicide.28

Nevertheless, in a recent review of the practice, the authors
critique the way in which such agreements are now used
and note the paucity of any solid evidence that they are
effective. 29 The agreement, consisting merely of a request
that the patient affirm that she or he would not take her or
his life, was originally conceived as an assessment tool. If a
patient refused to make such a vow or sought to limit or
qualify it, then they were deemed to be at increased risk of
suicide. 30 In practice over the years, the concept of a no-
suicide contract has morphed into an actual contract
between patient and physician by which the patient
commits not to engage in self-harm. One of the concerns
expressed about this transformation is that the physician
may rely excessively on the existence of the contract and fail
to perform a careful assessment of the suicide risk, heavily
exaggerating the patient's willingness or ability to report
suicidal thoughts or impulses. 31

An alternative approach to suicide prevention in
psychiatry has been advocated that calls for a greatly
reduced emphasis on formal written contracts in favor of a

27 Id. at 228.
28 See Robert C Drye et al., No-Suicide Decisions: Patient

Monitoring of Suicidal Risk, 130 AM. J. PSYCHIATRY 171 (1973).
29 Keelin A. Garvey et al., Contracting for Safety with Patients:

Clinical Practice and Forensic Implications, 37 J. AM. ACAD. PSYCHIATRY
& L. 363 (2009).

30 See Drye et al., supra note 28.
31 See Garvey et al., supra note 29.

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robust informed consent process. 32 Many of the criticisms
and concerns raised by these authors about the widespread
practice of using suicide-prevention contracts are equally
applicable to opioid contracts. For example, if the primary
motivation for a contract is to meet a need or concern of the
clinician, the result may be to undermine rather than
promote establishment of a strong therapeutic alliance. The
authors note, "Patients are very sensitive to actions meant
to protect clinicians but presented in the guise of being in
the patient's interests."33  Insistence on a contractual
agreement can adversely affect the patient's motivation to
engage meaningfully in the development of and adherence
to a treatment plan. And just as critics of no-suicide
contracts contend that they can reasonably be viewed as a
form of defensive medical practice, the "risk management"
motivation suggested by the proliferation of opioid contracts
is not diminished by the abundance of rhetoric by their
proponents that these instruments are truly in the best
interests of all concerned.

It is interesting to note the areas of clinical practice
where one might have expected to find the use of contracts,
particularly if the assertions of the proponents of opioid
contracts were valid, but where in fact the medical
literature suggests that they are not common. A relatively
recent Cochrane review considered "contracts between
patients and healthcare practitioners for improving
patients' adherence to treatment, prevention, and health
promotion activities."34 This review assessed the quality of
published data and the strength of evidence concerning the
efficacy of such contracts. The aspects of patient care for
which published data was available for consideration
included the following: treatment of patients with addiction

32 See Michael Craig Miller et al., Talisman or Taboo: The
Controversy of the Suicide Prevention Contract, 6 HARV. REV.
PSYCHIATRY 78 (1998).

33 Id. at 81.
34 Xavier Bosch-Capblanch et al., Contracts Between Patients and

Healthcare Practitioners for Improving Patients' Adherence to
Treatment, Prevention and Health Promotion Activities, COCHRANE
DATABASE SYSTEMATIC REVS. no. 2, 2007, Art. No.: CD004808. DOI:
10.1002/14651858.CD004808.pub.3.

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disorders, hypertension, obesity (weight control), as well as
a small number of miscellaneous studies concerning
patients with diabetes, arthritis, and tuberculosis. Opioid
therapy was not among those listed, nor was solid organ
transplantation or chemotherapy for treatment of various
malignancies. The absence of published data indicating
that contracts are routinely used in other patient care
situations where the risks of nonadherence are at least as
significant as opioid analgesia tends to undermine the
argument that opioid contracts are essential tools for
protecting patients from the risks of deviating from the
prescribing clinician's parameters. The reviewers concluded
that many of the clinical trials were of poor quality,
involved small numbers of participants, and provided
insufficient evidence upon which to base a recommendation
for the routine use of contracts as a means of improving
patient adherence. 35

Accordingly, much of the enthusiasm for opioid contracts
has been completely detached from any solid evidence that
they improve treatment efficacy.36 The reasoning of the
proponents appears to be that the current absence of
demonstrable evidence of the actual or potential harmful
consequences of opioid contracts and random urine drug
screens provides a sound basis upon which to conclude that
they are beneficial. In this regard, the discussion noted
above in the psychiatric literature about no-suicide
contracts should provide at least some measure of concern
that insistence and reliance upon contracts may in fact be
both unnecessary and contraindicated.

Finally, lost in the rhetoric that zealously advocates for
opioid contracts and random urine drug screens for all
patients with chronic pain who are candidates for opioid
therapy are the important cautionary points about the
nature of nonadherence. One commentator describes as
many as five types of nonadherence: undercompliance
(nonuse and partial use), overcompliance, drug holiday,
underuse followed by overuse before clinical visits (white-
coat phenomenon), and randomization (inconsistent use of

s Id.
36 See Fishman et al., supra note 13.

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medication).37 Fishman and colleagues specifically note
these varieties of noncompliance and the multiple reasons
that may motivate or underlie both under and
overutilization of prescription medications. Addiction or
abuse is only one of many different possible causes of the
latter.38 They go on to point out, "A temptation exists to
assume that patients with chronic nonmalignant pain who
are not adherent to a treatment regimen are abusing
medications. Other causes of nonadherence . . . must be
addressed in this population."39  They also note that
"[ilmplementing and informing patients of ongoing
adherence monitoring do not, in and of itself, assure good
compliance . . . improving the ability of clinicians to discern
nonadherence from ineffective therapy as the cause of drug
failure will likely have substantial effect on treatment
efficacy and safety."40

We now turn to the consideration of informed consent.
The pain medicine literature discussing opioid contracts we
will consider in subsequent sections of this article treats
informed consent as an important element of opioid
therapy, but not one obviates the need for opioid contracts.
We argue that such thinking reflects an exceedingly narrow,
rigid, and ultimately impoverished conceptualization of
informed consent and its role in enhancing a shared
understanding and purpose in pursuing a particular form of
therapy.

VI. INFORMED CONSENT

The irrational exuberance many physicians have
expressed for the indiscriminate use of opioid contracts
strongly suggests a common belief that these documents
provide a benefit which cannot be achieved through

37 JOSEPH A. PALADINO, AM. COLL. OF CLINICAL PHARMACY, IS
COMPLIANCE WITH OUTPATIENT RX THERAPY COMMON? (1991).

38 Scott M Fishman et al., Adherence Monitoring and Drug
Surveillance in Chronic Opioid Therapy, 20 J. PAIN & SYMPTOM MGMT.
293, 295 (2000).

39 Id. at 304.
40 Id. at 303.

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adherence to a thorough, ongoing, and well-documented
informed consent process, and that this benefit outweighs
any potential harm to the patient or the mutual trust and
respect that is essential to the establishment and
maintenance of a sound physician-patient relationship. We
respectfully disagree and will make the case that informed
consent as originally conceived would provide all of the
purported benefits and reduce or eliminate many of the
potential harms posed by opioid contracts.

The duty to obtain an informed consent and to document
the pertinent details of that consent in the medical record
has been well-established in both American law and
bioethics for decades for all but the most minimal and
benign of medical interventions and therapies, and would
certainly be required for treatment with opioid analgesics. 41
For purposes of this discussion, it should suffice to simply
reiterate the essential elements of an informed consent and
well-recognized principles for engaging in the informed
consent dialogue, because in doing so it becomes clear why a
written contract concerning opioid therapy is unnecessary
unless the requisites of the informed consent doctrine have
not been met.

A. Elements of Informed Consent as They Relate to Pain
Management

A starting point is the diagnosis, along with an
explanation of how and why the intervention will be likely
to rule in or rule out one or more of the likely possibilities.
In the case of opioid therapy, it is important for both the
clinician and patient to understand that in contemporary
medical thought chronic pain may well be a diagnosis rather
than merely a symptom of some underlying disease or
injury.42 The second element of informed consent is a
discussion of the nature of the therapeutic intervention.

41 Ben A. Rich, A Prescription for the Pain:' The Emerging
Standard of Care for Pain Management, 26 WM. MITCHELL L. REV. 1
(2000).

42 NAT'L CTR. FOR HEALTH STATISTICS & CTRS. FOR MEDICARE AND
MEDICAID SERVs., ICD-9-CM (6th ed. 2009).

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When this involves chronic opioid therapy, some basic
discussion of the properties of the medication or medications
to be prescribed should be provided, including how and why
the medication(s) functions to relieve pain. A third element
is the patient's prognosis with and without the
recommended treatment. Prognostication is considered
much more uncertain than diagnosis because of the many
other factors influencing how patient's react to and cope
with illness, as well as their willingness and ability to
adhere to a therapeutic regimen. This may be particularly
true of chronic pain patients on opioid therapy, which
makes candid exchanges and regular follow-up all that more
important.

A fourth element of consent-the anticipated benefits
and risks of treatment-is perhaps the most critical one
with regard to our contention that a properly conducted
informed consent process is the optimal means of achieving
the purported objectives of opioid contracts. This may be
the most challenging part of the informed consent process
for opioid analgesia because of the absence of solid clinical
evidence for most of the recommendations found in current
medical treatises and guidelines. 43 Because of the level of
concern about the percentage of patients on chronic opioid
therapy who may have or develop a propensity for aberrant
drug behaviors, the risks to be discussed with each patient
must include both those intrinsic to opioid therapy, as well
as the greatly increased risks to the patient if the
medication(s) is not taken as directed. 44 In the discussion of
the anticipated benefits of opioid therapy, the prescribing
physician should make clear what she or he believes to be
the realistic goal. There is now a strong consensus in the
pain medicine community that simply achieving and
maintaining a modicum of reduction in pain levels is not a
goal of treatment worthy of assuming the risks of long-term
opioid analgesia. It is essential, according to many thought

43 Roger Chou et al., supra note 16.
44 Dennis C. Turk et al., Predicting Opioid Misuse by Chronic Pain

Patients: A Systematic Review and Literature Synthesis, 24 CLINICAL J.
PAIN 497, 506-07 (2008).

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leaders in the field, that the goals of treatment include
improvement in the level of function.45

The recent emphasis in pain medicine that chronic
opioid therapy cannot be deemed effective if only reduction
in the levels of reported pain is achieved, but without
demonstrable functional improvement, has a somewhat
paternalistic if not authoritarian character. It relegates the
assessment of benefit entirely to the prescribing physician.
Ultimately, it is the patient who must assume the risks and
bear the burdens of any medical intervention, as well as
endure the pain, suffering, and disability associated with
the underlying condition. The victims of moderate to severe
chronic pain are often desperate for some measure of
deliverance from distress, and therefore may be willing to
assume risks that someone who has never shared their
experience, including clinicians, would consider to be
excessive. While accurate medical information is essential
to the risk/benefit calculation, ultimately it is a normative
and subjective, not purely scientific and objective
determination that each patient must reach, as with any
other treatment decision.

The final element of an informed consent involves
consideration of the alternatives to the recommended
treatment and the anticipated risks and benefits each would
involve. Of course, in all clinical situations, there is always
at least one other option to the recommended treatment,
i.e., doing nothing. This too involves risks, particularly if
the recommended treatment is deemed medically necessary.

B. Important Considerations in the Process of Informed
Consent for Pain Therapy

Informed consent, properly understood and practiced in
clinical medicine, is an ongoing process, and in no situation
is that true more than in the management of chronic pain.
This notion is confirmed by the way in which opioid therapy
as a treatment option has come to be characterized in the

45 See, e.g., Amber Huntzinger, Guidelines for the Use of Opioid
Therapy in Patients with Chronic Noncancer Pain, 80 AM. FAMILY
PHYSICIAN 1315 (2009).

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literature, i.e., as a "trial."46 An initial treatment plan and
the goals it is formulated with the intent of pursuing is an
essential feature of the consent process. Consequently, that
plan, and the efficacy of the specific measures undertaken
to achieve its purposes, must be periodically evaluated
based upon the patient's experience. This process is
absolutely essential to shared decision making within the
therapeutic dyad.

One reason why some clinicians view consent as a
discrete event, even outside the context of surgery, is an
obsessive focus on the signing of the consent form. The form
is simply a piece of documentary evidence. This is just one
reason why the wholesale adoption of opioid contracts is
problematic. As we will discuss more fully in a subsequent
section, such contracts tend to take a certain form,
consisting of a long list of "thou shalts" and "thou shalt
nots" to which the patient is expected to unquestioningly
agree in order to be provided opioid analgesia. There is no
genuine meeting of the minds or any effort to tailor the
agreement to a specific treatment plan in the formulation of
which the patient has played any meaningful role.4 7

When a patient executes a written consent to opioid
therapy she or he is explicitly agreeing to adhere to the
treatment regimen, particularly taking the medications as
directed. Such directions will likely include not only the
specific medication(s) and dosage, but also the proviso that
no similar medications will be sought from other physicians.
Consent to the treatment plan will also include a
commitment to regular follow-up appointments to reassess
the efficacy of treatment and the presence of any
complications from the prescribed medications. So
understood, the detailed written consent covers all
important aspects of sound opioid therapy and contains
many of the uncontroversial provisions of an opioid contract,
but does so in a way that does not single out chronic pain
patients as do separate opioid contracts.

46 See Chou et al., supra note 13, at 115-16.
47 Robert M. Arnold et al., Opioid Contracts in Chronic

Nonmalignant Pain Management: Objectives and Uncertainties, 119
AM. J. MED. 292, 293-95 (2006).

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Properly understood and appreciated, the informed
consent process is not merely a boilerplate form that the
patient must be persuaded to sign with a minimum of
examination and explanation. We are not alone in our
advocacy of it as a means of establishing and enriching the
therapeutic dyad. Particularly in areas fraught with
uncertainty and challenge, of which opioid therapy for
chronic pain is a prime example, it allows thoughtful and
engaged physicians to acknowledge the profound level of
uncertainty that pervades many aspects of patient care.48

There is, however, one aspect of the informed consent
process that may require modification if it is to serve as
superior alternative to an opioid contract. Out of respect for
individual autonomy, patients are allowed to decline to
receive information about the nature of a proposed therapy
and its benefits, risks, and alternatives. However, the
emerging paradigm of responsible opioid prescribing
essentially requires that the physician impart to the patient
what is expected of her in order to safely embark upon a
trial of opioid analgesia. Thus, it may not be acceptable
practice to allow patients to cultivate their ignorance of the
conditions upon which a course of opioid therapy will be
undertaken. With this perspective on informed consent and
the recommended process by which it is used to facilitate
shared decision making on a treatment plan, we now turn to
the most common elements of opioid contracts in an effort to
ascertain whether they offer anything to physician or
patient that cannot be achieved through clear
documentation of the process described above.

VII. OPIOID CONTRACTS IN THE MANAGEMENT OF CHRONIC
PAIN

Discussion of opioid contracts for chronic pain patients
undergoing opioid therapy is a relatively recent
phenomenon. Much of the early analysis of this
phenomenon in pain medicine was done by Fishman and

48 See, e.g., Thomas G. Gutheil et al., Malpractice Prevention
Through the Sharing of Uncertainty. Informed Consent and the
Therapeutic Alliance, 311 NEW ENG. J. MED. 49 (1984).

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colleagues ten to twelve years ago. Even then, however,
they reported that "contracts are widely used in the chronic
administration of potentially abusable substances or
management of lethal behaviors."49  Fishman and
colleagues found that by far the most common provisions in
the thirty-nine contracts they reviewed dealt with the
following: commitment by patient to avoid improper use of
controlled substances (95%), specification of terms for
disciplinary termination of the patient for violating the
contract or engaging in other inappropriate behavior (92%),
limitations on replacing medications or changing
prescriptions (85%), providing physicians with relevant
information (74%), and submission to random urine drug
screens (69%).50 At the opposite end of the continuum, the
least common provisions of these contracts were those that
affirmed any joint responsibility of physician and patient for
opioid therapy (5%), documented physician obligations
under the contract (3%), or acknowledged the physician's
obligation to provide treatment information to the patient
(3%).51

Fishman and colleagues further observed that "very few
of the reviewed contracts suggest patients have any role in
determining their terms.52  Consequently, while these
authors suggest that in some idealized sense the contract "is
intended to enhance the therapeutic relationship by
initiating and supporting an alliance between the patient
and the physician,"53 it is very difficult to discern how the
typical provisions they found in their survey would be
conducive to that goal. Rather, the most typical provisions
strongly suggest an approach by which the prescribing
physician lays down the law governing the patient's conduct
and empowers the physician to terminate the relationship
forthwith in the event of any violation by the patient.
Similarly, Collen's survey of private practitioners revealed

49 Scott M Fishman et al., The Opioid Contract in the Management
of Chronic Pain, 18 J. PAIN & SYMPTOM MGMT. 27, 27-28 (1999).

50 Id. at 30-31.
51 Id.
52 Id. at 32.
53 Id. at 28.

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that the vast majority of contract provisions pertained to
the consequences to the patient for violating any term of the
agreement, rules regarding prescriptions and refills thereof,
and submission to random urine drug screens. 54  It is
plausible to suggest that for many patients, the insistence
upon execution of a written contract with a long list of
seemingly harsh and unilateral conditions by a physician
will be a unique and disturbing experience.

VIII. THE UNIVERSAL PRECAUTIONS APPROACH

Ever-increasing utilization of opioid contracts and
mandatory random urine drug screening had already
become a prominent feature of pain medicine specialty
clinics by 2005, when a seminal article advocating their use
as a form of "universal precautions" in pain medicine was
published.55  Mimicking the wholesale adoption of a
universal precautions approach to infectious diseases such
as HIV and hepatitis, the authors recommend that certain
minimal precautions be taken with regard to "all chronic
pain patients regardless of pharmacologic status."5 6

Underlying the application of the infectious disease model
to chronic pain patients is the belief that identifying
patients at risk of addiction or diversion is essentially as
difficult as identifying patients with HIV or other serious
infectious diseases and the consequences of a failure to do so
equally perilous.

In addition to our previously mentioned observation that
the universal precautions approach, insisting as it does on
opioid contracts and random urine drug screens for all
patients on opioid analgesia regardless of the level of risk
assessed, is inconsistent with current national guidelines
and model policies, we wish to note further the disanalogy

54 Mark Collen, Analysis of Controlled Substance Agreements from
Private Practice Physicians, 23 J. PAIN & PALLIATIVE CARE
PHARMACOTHERAPY 357 (2009).

55 See Douglas L. Gourlay et al., Universal Precautions in Pain
Medicine: A Rational Approach to the Treatment of Chronic Pain, 6
PAIN MED. 107 (2005).

56 Id. at 109.

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between the two. Universal precautions in infectious
disease are applied to all patients in all patient care
settings. By contrast, not all patients receiving medications
posing risks when not taken as directed are subjected to
contract conditions and random urine drug screens; only
those whose medically-indicated treatment includes an
opioid analgesic are subject to those consequences. We will
address in detail below the dubious claim that this
application ameliorates the already prevalent
stigmatization chronic pain sufferers who take opioids
endure. For now, it is sufficient merely to note that this
distinction undermines the analogy between the universal
precautions approach as to infectious disease and that
applied as to chronic pain sufferers for whom opioids are
prescribed.

The universal precautions approach in pain medicine
includes a total of ten elements, only one of which do we
believe is problematic, or two if opioid contracts and random
urine drug screens are treated separately. The enumerated
precautions are as follows:

1. Diagnosis with appropriate differential;
2. Psychological assessment including risk of addictive

disorders;
3. Informed consent;
4. Treatment agreement (including a provision whereby

the patient agrees to random urine drug screens);
5. Pre-and post-intervention assessment;
6. Appropriate trial of opioid therapy +/- adjunctive

medications;
7. Reassessment of pain score and level of function;
8. Periodic assessment of 4 A's of pain medicine:

analgesia, activity, adverse effects, aberrant
behavior;

9. Periodic review of pain diagnosis and comorbid
conditions including addictive disorders; and

10. Documentation.

Prior to listing these ten commandments of responsible
opioid prescribing the authors offer the sweeping assertions

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that "by applying the following recommendations, patient
care is improved, stigma is reduced, and overall risk is
contained."5 7 Neither argument nor any reference to the
literature is provided in support of any of these claimed
benefits. Similarly, in a more recent articulation of the
universal precautions approach, Gourlay and Heit declare,
"Universal precautions as a concept is based on mutual
trust and respect between patient and practitioner alike."58

There is an Orwellian cast to the insistence that an effective
means of demonstrating and promoting trust is for the
empowered party in a relationship to demand that the
disempowered party initially and continuously prove to the
other by execution of a rigorous written contract and
tangible evidence (urine drug screens) that they are
upholding their pledge to access, utilize, and secure
medications in strict accordance with doctor's orders.5 9 We
have already presented argumentation in support of the
position that properly understood and implemented,
documentation of the informed consent process achieves
whatever benefits are believed to flow from a written opioid
contract.

Our objection to opioid agreements and random urine
drug screens for all patients undergoing a trial of opioid
therapy is based upon an understanding that assessing the
presence or risk of addiction, as well as the potential for
abuse or diversion of opioids is a reasonable and perfectly
acceptable universal precaution. This approach is
consistent with national guidelines and model policies and
implicitly ascribes a minimal level of efficacy for currently
available approaches to assessment of risk, to which we now
turn. Before doing so, however, it is important to
emphasize how much more expansive and complicated is
the universal precautions risk assessment for opioid

s7 Id.
58 Douglas L. Gourlay and Howard A. Heit, Universal Precautions

Revisited: Managing the Inherited Pain Patient, 10 PAIN MED. S115,
S116 (2009).

59 See Lisa Victor & Steven H. Richeimer, Trustworthiness as a
Clinical Variable: The Problem of Trust in the Management of Chronic,
Nonmahgnant Pain, 5 PAIN MED. 385 (2005).

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analgesia is than for most other medical treatments. Not
only must the clinician arrive at a good faith medical
judgment that the risks inherent in taking a particular
opioid are outweighed by the reasonably anticipated
benefits, but she or he is admonished to assess the risk that
the patient might not strictly adhere to the treatment
regimen or might not properly sequester the medication.
Although it has been extensively documented that
nonadherence is a widespread problem in clinical practice,
assessing the risk of that for each patient prior to initiating
treatment is not generally viewed as part of the minimal
standard of acceptable care. The only possible exception
might be solid organ transplantation. Because of the
ongoing scarcity of viable organs for transplantation, it is
important to identify and be prepared to support patients
who are prime candidates for transplant but who present
with factors suggesting that adherence may be
challenging.60  Nevertheless, insistence upon written
contracts signed by patients pledging adherence and
submitting to monitoring protocols do not feature
prominently in the transplantation literature.

It is beyond the scope of this article, and the
competencies of the authors, to provide a detailed review
and evaluation of the ever-increasing panoply of risk
assessment tools upon which clinicians considering a trial of
opioid therapy can draw. One overview lists nine of these.6 1

Some are relatively simple and straightforward and
therefore lend themselves to primary care settings, whereas
others are more elaborate and time-consuming to utilize,
and hence likely to be more suited to specialized pain
medicine clinics and referral centers. For our purposes, the
important point is that responsible risk assessment and
stratification of patients can be undertaken by clinicians

60 See Brigitta Bunzel & Kurt Laederach-Hofmann, Solid Organ
Transplantation: Are There Predictors For Posttransplant
Noncompliance? A Literature Review, 70 TRANSPLANTATION 711, 715
(2000).

61 Steven D. Passik & Pamela. Sqyire, Current Risk Assessment
and Management Paradigms: Snapshots in the Life of the Pain
Specialist, 10 PAIN MED. S101, S104 (2009).

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consistent with current nationally promulgated clinical
practice guidelines and model policies, supporting the
reasonable exercise of clinical judgment as to whether a
particular patient's situation warrants a heightened level of
oversight and monitoring. The fact that such risk
assessment is not foolproof is beside the point, since no
physician is ever held to a standard of perfection. Any
suggestion that written opioid contracts and random urine
drug testing insures such perfection cannot stand careful
scrutiny, as the next section will demonstrate.

IX. ADHERENCE MONITORING THROUGH URINE DRUG
SCREENING IN OPIOID THERAPY

An article by Fishman and colleagues candidly reviews
the challenges and limitations posed by various strategies to
monitor adherence to opioid therapy. 62 First, their review
acknowledges the critical point that we will develop below
that contracts have the potential to perpetuate stigma.
Second, Fishman and colleagues, consistent with the above
noted critiques of no-harm contracts in psychiatry, warn
that opioid contracts may create the illusion of adherence
and result in a lower level of clinical scrutiny in the follow-
up. Third, on the matter of laboratory testing for opioids,
these authors note that "[sluch tests are often compromised
by variability and limitations in obtaining specimens,
custody of specimens, laboratory methodologies, and
interpretation of laboratory data."63 There is a risk of both
false negative and false positive results. Concentrations
below the inherent limits of detection for a particular assay
may result in a negative determination for a prescribed
medication despite its actual presence in the patient.
Oxycodone, for example, may not test positive at even at a
therapeutic dosage. False positive results may be caused by
something as innocuous as the ingestion of poppy seeds.

These authors also note that savvy clinicians should not
jump to the conclusion that nonadherence with opioid
therapy necessarily involves abuse. The broad range of

62 See Fishman et al., supra note 49.
63 Id. at 297.

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patient behaviors regarding nonadherence is consistent
with other studies indicating that failure to strictly adhere
to prescription medication regimens is a widespread
phenomenon cutting across many clinical conditions and
prescription drugs.64 Without careful inquiry into the type
of nonadherence and the factors underlying it, clinicians
may leap to erroneous conclusions that in turn lead to
precipitous and unwarranted discontinuation of opioid
therapy or in the most extreme cases discontinuation of the
physician-patient relationship.

We turn now to the final portion of our argument against
the use of opioid contracts and universal drug screening, in
which we address the risks of stigmatization that attend the
widespread use of such tools. Herein, we attempt to clarify
some of the muddled thinking on the subject of stigma,
which generally proceeds absent any informed theoretical
understanding of the considerable literature on disease and
health stigma, and we attempt to demonstrate the ethical
harms that result from intensifying stigmatization of an
already highly-stigmatized group (chronic pain sufferers).
This final section balances the emphasis on the therapeutic
dyad thus far with a macrosocial approach that focuses on
the determinants of population health and relies on
empirical evidence drawn primarily from social
epidemiology. It is only through such a macro-level
approach that the true health impact of stigma can be
understood, and the ethical harms fully apprehended.

X. CHRONIC PAIN, STIGMA, AND OPIOID CONTRACTS: A
POPULATION-LEVEL BIOETHICs ANALYSIS

As we have chronicled the rise of opioid contracts as a
tool for universal precautions, we wish now to focus on one
of the primary justifications offered for their use: that of
avoiding stigmatization. Although this rationale is
frequently cited, there is little literature that closely
examines concerns of stigmatization as a justification for
moving to the universal use of such contracts. This is

64See id.

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surprising at least in part because good evidence indicates
that stigmatization is a common companion for many
chronic pain sufferers 65 and that the risks and extent of
such stigmatization are distributed disproportionately
among various social strata (race, class, gender, age, etc.).66
Although precise quantitative evidence on the prevalence of
chronic pain stigma is lacking, the available evidence
suggests its commonality, intensity, and inequitable
distribution.6 7 Disease stigma in general is an enormous
clinical and ethical problem. Because it can worsen disease
outcomes, imposes a distinct form of psychosocial suffering,
and is independently associated with increased morbidities
and mortalities, such stigma is a major public health
problem.68 Moreover, as Burris points out, narratives of

65 E.g., Goldberg, Job and the Stigmatization of Chronic Pain,
supra note 1, at 431; Carole C. Upshur et al., 'They Don't Want
Anything to Do with You': Patient Views of Primary Care Management
of Chronic Pain, 11 PAIN MED. 1791, 1794-95 (2010); Jean E. Jackson,
Stigma, Liminality, and Chronic-Pain: Mind-Body Borderlands, 32 AM.
ETHNOLOGIST 332 (2005); Anne Werner & Kristi Malterud, It is Hard
Work Behaving as a Credible Patient: Encounters between Women with
Chronic Pain and their Doctors, 57 SOC. SCl. & MED. 1409, 1414-15
(2003); Joseph J. Marbach et al., Losing Face: Sources of Stigma as
Perceived by Chronic Facial Pain Patients, 13 J. BEHAV. MED. 583
(1990).

66 See Goldberg, Job and the Stigmatization of Chronic Pain, supra
note 1; Jackson, supra note 65; Werner & Malterud, supra note 65;
Dania Palanker, Note, Enslaved by Pain: How the US Public Health
System Adds to Disparities in Pain Treatment for African Americans,
15 GEORGETOWN J. ON POVERTY L & POL'Y 847 (2008).

67 See sources cited supra note 65;_see also Palanker, supra note
66.

68 See, e.g., Rebecca M. Puhl & Chelsea A. Heuer, Obesity Stigma:
Important Considerations for Public Health, 100 Am. J. PUB. HEALTH
1019, 1019-20 (2010); J. Hong et al., The Psychosocial and Occupational
Impact of Chronic Skin Disease, 21 DERMATOLOGIC THERAPY 54, 57-58
(2008); Peter A. Vanable et al.. Littlewood, Impact of HIV-Related
Stigma on Health Behaviors and Psychological Adjustment among HIV-
Positive Men and Women, 10 AIDS Behav. 473, 479-80 (2006); Bruce G.
Link & Jo C. Phelan, Stigma and Its Public Health Implications, 367
LANCET 528, 528-29 (2006); D. Vardy et al., Experiences of
Stigmatization Play a Role in Mediating the Impact of Disease Severity
on Qualty of Life in Psoriasis Patients, 147 BRITISH J. DERMATOLOGY
736, 741-42 (2002).

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disease stigma "would by and large melt a heart of stone, so
that even if [disease stigma] had no adverse effects on
health or public health practice, it may readily be seen as
repugnant in a humane society."69

In addition, there is a well-developed literature on the
significance of trust between the patient and the provider in
both chronic disease management and chronic pain
management in particular. 70  Because the relationship
between stigma and trust is profoundly inverse, it is
essential to interrogate the presumed causal relationship
between increased utilization of universal opioid contracts
and decreased chronic pain stigma. We argue in this
section that although the intention of ameliorating the
absolute and inequitably distributed burdens of this stigma
is laudable, the move to universal opioid contracts is both
ill-advised and counterproductive, and it is much more
likely to intensify chronic pain stigma than to ameliorate it.
We further contend that this intensified stigmatization will
disproportionately impact chronic pain sufferers in the most
marginalized communities. We draw on Powers and
Faden's account of social justice in health policy, which
posits that actions that can be predicted to intensify the
"densely-woven patterns of disadvantage" in which the most
vulnerable and marginalized members of American society
are situated are fundamentally unjust.7 1 Because universal
opioid contracts are likely to intensify stigma and erode
trust, they run a dangerously high likelihood of
exacerbating such densely-woven patterns of disadvantage.

69 Scott Burris, Disease Stigma in US Public Health Law, 30 J.L.
MED. & ETHICS 179, 182 (2002).

70 See Leonard E. Egede & Yvonne Michel, Medical Mistrust,
Diabetes Self-Management, and Glycemic Control in an Indigent
Population With Type 2Diabetes, 29 DIABETES CARE 131 (2006); Denise
E. Bonds et al., The Association of Patient Trust and Self-Care Among
Patients with Diabetes Mellitus, 5 BMC FAMILY PRACTICE 26 (2004);
Thomas A. LaVeist et al., Attitudes about Racism, Medical Mistrust,
and Satisfaction with Care among African American and White Cardiac
Patients, 57 MED. CARE RES. & REV. 146 (2000).

71 See MADISON POWERS & RUTH FADEN, SOCIAL JUSTICE: THE
MORAL FOUNDATIONS OF PUBLIC HEALTH AND HEALTH POLICY passim, 71
(John Harris et al. eds., 2006).

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Given that there is a paucity of high-quality evidence
showing significant benefits stemming from the use of
universal opioid contracts, the very real harms that are
likely to flow from their use renders their adoption ethically
dubious.

First, as we have noted above, we reject the peculiar
notion that universal opioid contracts, by virtue of their
utilization among all chronic pain sufferers for whom
opioids are prescribed, ipso facto diminish chronic pain
stigma. The generally accepted notion of disease stigma
stems from Goffman's seminal work 72 and, as interpreted by
Link and Phelan, 73 consists of two central criteria: (1) a
social group must mark another social group as different, by
which process in-groups and out-groups are defined and
branded, and (2) the in-group must assign a normative
valence to the out-group; the out-group must be marked as
deviant. Because the marking of difference and the
assignment of deviance require actors, it is inevitably people
who stigmatize other people. Moreover, the capacities to
mark and to assign deviance are a function of the social,
economic, and political power wielded by the in-group. 74

This links stigma to larger social inequalities, a point we
shall return to shortly.75

As applied to universal opioid contracts, there is little
rationale for the prima facie claim often asserted in the
literature on universal opioid contracts that marking an
already highly-stigmatized subgroup as an out-group in this
additional sense would inherently be likely to ameliorate
that stigma. Moreover, the first portion of this definition of
stigma shows the absurdity of the assertion that by virtue of
their universality opioid contracts do not discriminate.
Such contracts unquestionably mark out a social group as
different, the social group in question being chronic pain
sufferers who utilize opioid analgesics. Pain sufferers for
whom opioids are either not indicated or are not

72 See ERVING GOFFMAN, STIGMA: NOTES ON THE MANAGEMENT OF

A SPOILED IDENTITY 126-160 (1963).
73 See Link & Phelan, supra note 68, at 528-29.
74 Id.
7 Id.

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prescribed-a larger group than the frenzied attention
expended on opioids and pain would suggest-are not
subjected to such contracts. Nor, to make the point more
obviously, are adherence contracts utilized among patients
for whom aspirin, beta blockers, or metformin is prescribed.
Note here that the "difference" criterion of stigma is in
theory distinct from the "deviance" criterion. Thus, the fact
that chronic pain patients who take opioids are marked out
as different does not necessarily show that the group is
being stigmatized. However, it does repudiate the oft-
asserted and wholly unsupported idea that the utilization of
universal opioid contracts somehow fails to discriminate, or
mark out as different, a particular social group.

It is essential to ask why it is that opioid-taking chronic
pain sufferers are being marked as different. The answers
given rest on the risks said to inhere in the prescription and
use of opioid analgesics, the most significant of which are
those of addiction and diversion. This implies that the use
of opioids is "risky," and that the "riskiness" of prescribing
and taking opioids is what merits the differential treatment.
In turn, the presumed riskiness of chronic pain sufferers
who take opioids highlights Jean Jackson's point that
chronic pain is properly regarded as a liminal state in
American society.76  In countless ways, chronic pain
sufferers exist on the borderlands, and the classification of
those who take opioids reflects this point-not quite drug
abusers or addicts, but certainly of social concern in ways
that those who take metformin or ranitidine are not. Risk
is of course a social phenomenon, which means it can spread
along social networks; in this sense the riskiness of chronic
pain patients that take opioids can flow to the physicians
that prescribe those opioids, who undergo perceived risks in
so doing and in turn become risky and liminal in and of
themselves in the eyes of other social and institutional
authorities such as state medical boards and law
enforcement agencies. As Jackson points out, this
liminality matters for chronic pain sufferers in particular
because those whom societies regard as liminal are at

76 See Jackson, supra note 65; JEAN E. JACKSON, CAMP PAIN:
TALKING WITH CHRONIC PAIN PATIENTS 102-108 (2000).

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heightened risk of being marked as different and regarded
as deviant.7 7 Liminality in some contexts, chronic pain
apparently being one of them, is a social marker for
stigmatization.

While the definition of stigma allows for a conceptual
distinction between marking of difference and assignation of
deviance, there is unfortunately ample reason to believe
that the risk of slippage is extremely high. Kurzban and
Leary argue for a functional-evolutionary explanation of
stigmatization that explains "the important question of why
an inherently social species with a strong need for social
acceptance should be so inclined to reject members of its
own kind."78 They posit that stigmatization fulfills several
evolutionary roles centering on the need for humans to
avoid some of the intensely negative experiences of social
life. 79 Hence, Kurzban and Leary contend that "human
adaptations for sociality include cognitive mechanisms that
cause people to be selective in their social interactions."8 0

They conclude that the commonality of stigma in social life
can be explained at least in part by these adaptations.8 ' If
there is merit to this theory, it suggests that a neat and
easily-made distinction between difference and deviance is
not reflective of the real costs of social life and that
stigmatization is rather a common adaptive mechanism for
coping with and managing those costs.

In addition, the extremely common experiences of
disease stigma in Western history cast serious doubt on the
extent to which the theoretical distinction between
difference and deviance can be maintained in practice.82

Thus even if we completely deny the evolutionary theory of
stigmatization, disease stigma in the West is historically
such a common occurrence as to belie the idea that an
empowered group merely marking out a marginalized group

7 7 Id.
78 R. Kurzban & M.R. Leary, Evolutionary Origins of

Stigmatization: The Functions of Social Exclusion, 127 PSYCHOLOGICAL
BULL. 187, 187 (2001).

7 Id.
80 Id. at 189.
81 Id.
82 See Goldberg, supra note 1.

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as different on the basis of a recognized disease will
generally be socially innocuous. History suggests the
contrary.

Furthermore, even granting for the sake of argument
that the historic and easy slippage between difference and
deviance somehow does not occur with a group that already
endures much stigma, the suspicion enshrined in universal
opioid contracts may have a disparate impact on already
marginalized and vulnerable groups. The term "disparate
impact" is a legal term of art, with roots in
antidiscrimination law. The necessity for prohibition of
legal regimes and frameworks that had disparate impacts
became apparent during the Civil Rights Era in particular,
taking shape in the seminal 1971 case of Griggs v. Duke
Power Co. 83 In that case, Duke Power Company ("Duke")
instituted an intradepartmental transfer policy in 1955 for
its employees that required completion of a high school
education. 84 Immediately subsequent to the effective date
of Title VII of the Civil Rights Act, Duke added a second
provision to the transfer policy, requiring putative
transferees to "register satisfactory scores on two
professionally prepared aptitude tests, as well as to have a
high school education."85 These requirements applied to all
employees, whether Caucasian or African-American.8 6

Thirteen African-Americans filed suit under Title VII,
arguing that the practices were discriminatory even though
they were facially neutral. The U.S. Supreme Court agreed,
noting that under the requirements white employees fared
far better than their black counterparts, traceable in large
part to the legacy of inferior education offered to African-
Americans in North Carolina, where the action arose.87 The
Court reasoned that "absence of discriminatory intent does
not redeem employment procedures or testing mechanisms
that operate as 'built-in headwinds' for minority groups and

88 401 U.S. 424 (1971).
84 Id. at 427.
85 Id. at 427-28.
86 Id. at 429.
87 Id. at 430.

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are unrelated to measuring job capability."88 Moreover, the
Court noted, Title VII is directed at "the consequences of
employment practices, not simply the motivation." 89

We utilize the disparate impact analysis here solely by
way of analogy; that is, we are agnostic on the question of
whether the use of universal opioid contracts gives rise to
an actionable civil rights claim. Rather, we are focused on
the ethical underpinnings of disparate impact analysis,
which suggests that even policies that are universally
applied can be intolerable if they have a disparate impact on
an identifiable social group. Applied here, closer scrutiny
suggests ample reason to believe that universal opioid
contracts may have just such a disparate impact on those
most vulnerable members of the communities of chronic
pain sufferers that take opioids.

Regarding these communities, there are stark inequities
in the diagnosis and treatment of chronic pain, inequities
which revolve around social strata like race, class, gender,
and rurality, among many others.90  Given the well-
documented fact that social disadvantages tend to cluster,
those suffering from one form of social inequality are much
more likely to experience the deleterious effects of other
such inequalities.91  Thus, someone who is of low
socioeconomic status is significantly more likely to have low
educational attainment, work at a job for low pay, difficult
hours, and no job autonomy, and be exposed to various
health risks such as environmental hazards, violence, and
forms of discrimination (racism, sexism, ageism, etc.). As
Hilary Graham puts it, "[ulnequal social positions carry
with them unequal probabilities of being exposed to health

88 Id. at 432.

89 Id. at 433.
90 The literature on this topic is explosive. For an excellent

discussion and a list of sources, see INST. OF MEDICINE, supra note 5, at
2-9 through -26.

91 See POWERS & FADEN, supra note 71, at 71, passim; Jonathan
Wolff, Disadvantage, Risk and the Social Determinants of Health, 2
PUB. HEALTH ETHICS 214 (2009); Daniel S. Goldberg, Global Health
Care is Not Global Health: Populations, Inequities, and Law as a Social
Determinant of Health, in THE GLOBALIZATION OF HEALTH CARE 403 (I.
Glenn Cohen ed., 2013).

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hazards along the environment/risk factors/illness
pathway."92 Disease stigma is an example of one such
health hazard inasmuch as it is independently correlated
with poor health, 93 which implies that both the absolute
burdens of disease stigma and the distribution of those
burdens-which communities are at highest risk of being
stigmatized-are critical questions in thinking about just
and humane health policies.

Another such determinant of population health, one that
is closely related to stigma and discrimination, is trust,
which is frequently operationalized in the epidemiologic
literature as a component of social capital. 94 Although
space limitations preclude detailed discussions of the social
capital-health connection, there is little dispute in this
literature that trust is a key variable in determining health
and its distribution in populations. 95  The literature
suggests that the significance of trust and social capital to
health goes well beyond patient-provider relationships, but
specifically impacts such relationships at least in part
through the issue of medical mistrust.96 On this latter
point, there is solid evidence that medical mistrust has a
significant effect on outcomes of chronic disease

92 Hilary Graham, Social Determinants and their Unequal
Distribution: Clarifying Policy Understandings, 82 MILBANK Q. 101, 113
(2004).

93 See supra notes 65-70 and accompanying text.
94 Although the literature on this is immense, helpful starting

points includethe following: Simon Szreter & Michael Woolcock, Health
by Association? Social Capital, Social Theory, and the Political Economy
of Public Health, in HEALTH AND WEALTH: STUDIES IN HISTORY AND
POLICY 376-415 (2004); Michael Woolcock, The Rise and Routinization of
Social Capital: 1988-2008, 13 ANN. REV. POL. SCI. 469 (2010); Richard
Wilkinson & Kate Pickett, THE SPIRIT LEVEL: WHY GREATER EQUALITY
MAKES SOCIETIES STRONGER 51-62 (2009); Ichiro Kawachi et al., Social
Capital and Health: A Decade of Progress and Beyond, in SOCIAL
CAPITAL AND HEALTH 1-26 (Ichiro Kawachi et al. eds.); Thomas Abel,
Cultural Capital and Social Inequality in Health, 62 J. EPIDEMIOLOGY &
COMMUNITY HEALTH 1 (2008).

9 See Szreter and Woolcock, supra note 94.
96 See sources cited supra note 70.

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management.9 7 There is also good evidence that medical
mistrust is an enormous problem among communities
suffering from disproportionate rates of chronic illness,98

including pain.99

Whether intended or not, the use of universal screening
tools such as opioid contracts is likely to exacerbate this
mistrust. The suspicion institutionalized in universal
opioid contracts is therefore likely to have a
disproportionate impact on those communities of pain
sufferers that already suffer the most significant
inequalities in (1) the diagnosis and treatment of pain; (2)
social disadvantages that accumulate to produce more pain
and worse health; (3) stigmatization and discrimination
that are independently productive of poor health; and (4)
medical mistrust that is inversely correlated with effective
chronic disease management. The fact that all chronic pain
sufferers that take opioids may be required to sign opioid
contracts does not nullify the concern that such contracts
will have a disproportionate impact on those most
marginalized and vulnerable communities of pain sufferers.
As the disparate impact doctrine shows, even policies that
are universally applied can discriminate in unacceptable
ways, and we believe that universal opioid contracts are a
prime example of such a policy. The Supreme Court in
Griggs emphasized that the issue of disparate impact is not
a function of the motivations of the privileged, but is rather
focused on the consequences of the policies and practices at
issue on the marginalized. 100

97 See LaVeist et al., supra note 70; accord Wizdom Powell
Hammond, Psychosocial Correlates of Medical Mistrust Among African
American Men, 45 AM. J. COMMUNITY PSYCHOLOGY 87 (2010).

98 See LaVeist et al., supra note 70; B. Ashleigh Guadagnolo et al.,
Medical Mistrust and Less Satisfaction With Health Care Among
Native Americans Presenting for Cancer Treatment, 20 J. HEALTH CARE
PooR & UNDERSERVED 210 (2009); L. Ebony Boulware et al., Race and
Trust in the Health Care System, 118 PUB. HEALTH REP. 358 (2003).

99 Joseph 0. Merrill et al., Mutual Mistrust in the Medical Care of
Drug Users: The Keys to the 'Narc' Cabinet, 17 J. GEN. INTERNAL MED.
327 (2002).

100 Griggs v. Duke Power Co., 401 U.S. 424, 432 (1971).

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The concern that universal opioid contracts may have a
disparate impact on those communities of chronic pain
sufferers already experiencing the effects of cumulative
disadvantages and social inequalities implicates key issues
of social justice. One of the most sophisticated and
persuasive expositions of the concept is found in Powers and
Faden's work, in no small part because they integrate into
their theory much of the epidemiologic evidence regarding
the social determinants of health and the clustering of social
disadvantages. Powers and Faden utilize this evidence base
as a means of discerning which inequalities are of
paramount ethical significance for public health policy.
They conclude: "Which inequalities matter most? The
answer we propose is that inequalities that contribute to
systematic patterns of disadvantage are the ones that
matter most."101 Under this rubric, policies and practices
that exacerbate the densely-woven patterns of disadvantage
which characterizes life for those on the tail of the social
gradient are unjust and should not be tolerated.

Because stigma and mistrust are themselves key
variables in these densely-woven patterns of disadvantage,
policies and practices that raise a significant risk of
intensifying these experiences should at least be strongly
disfavored, and to the extent their intensification of stigma
and mistrust can be rigorously documented, can fairly be
labeled unjust. Powers and Faden's formulation of social
justice is critical insofar as it stretches the ethical scope of
justice beyond the distribution of primary goods. Thus,
even where the use of universal opioid contracts does not
preclude access to opioids for chronic pain sufferers that
require them, their capacity for if not their likelihood of
intensifying stigma and mistrust, and thereby worsening
densely-woven patterns of disadvantage among already-
marginalized communities, renders them ethically suspect.

Admittedly, the move to universal rather than ad hoc
opioid contracts is rooted in an ostensible desire to
ameliorate the stigmatization that so often accompanies the
lived experiences of chronic pain. This goal is laudable, and

101 See POWERS AND FADEN, supra note 71, at 193.

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our position here on the stigmatizing impact of universal
opioid contracts is compatible with a belief that ad hoc
opioid contracts pose significant concerns of selective
application, discrimination, and stigmatization. Our
conclusion is that there are profound reasons to doubt that
moving to universal opioid contracts substantially
ameliorates these concerns. Consequently, the appropriate
policy question is not whether universal opioid contracts are
preferable to ad hoc opioid contracts, but rather whether
universal opioid contracts are truly preferable to no opioid
contracts.

Disease stigma is pernicious. It is independently
productive of poor health, can cause significant psychosocial
suffering, and should not be tolerated in a just social order.
Practices and policies that threaten to institutionalize such
stigma should be avoided wherever possible. Moreover,
there is incontrovertible evidence that millions of
Americans suffer persistent, sometimes intense pain for
which safe and effective treatments exist, including but not
limited to opioids. Compounding this ethically intolerable
situation, devastating inequities in the assessment and
treatment of pain track virtually any social index that
researchers have cared to examine. The conclusion that, as
a society, the United States is and has been in the
aggregate treating pain extremely poorly is unavoidable.
We have grave doubts that it constitutes a humane
response to this problem to institute policies and practices
that pose a very real risk of stigmatizing the people whom
we as a society are already failing.

XI. CONCLUSION

In the summer of 2012, the Finance Committee of the
U.S. Senate announced that it was initiating an
investigation of the financial connections between certain
major pharmaceutical manufacturers of prescription pain
medications and experts in pain medicine, organizations
that issue professional guidelines for the prescribing of such

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medications, and advocacy groups for patients with pain.102

The primary motivating factor for the investigation appears
to be the prescription drug abuse epidemic alluded to in the
introduction to this article and. more particularly, the
suspicion that financial support of professional
organizations in the field of pain medicine and their thought
leaders has skewed practice guidelines, model policies, and
even articles in peer-reviewed publications toward
promotion of increased prescribing of opioid analgesics. The
focus of the media accounts of this announcement was
almost exclusively on those who acquire and misuse
prescription pain medications and the injury and death that
often follow from abuse of these medications. The plight of
the many patients who receive and benefit significantly
from these medications appeared as at best an afterthought
and secondary consideration. For all of the reasons
reviewed in this article, we now find ourselves in an
increasingly hostile environment for chronic pain patients
and the physicians who strive to treat them. More than
ever, these patients are at risk that our society will revert to
past prejudices against those who must rely on opioids for
pain relief and functional improvement, and there is also a
risk that our society will revert to a re-emergence of the
opiophobia that plagued the health professions not so very
long ago. The vulnerability of those afflicted with
significant and persistent pain demands that medicine and
society proceed with great caution in erecting barriers
between conscientious physicians and their patients.

Finally, our criticisms of opioid contracts and the
universal precautions approach ultimately do not depend on
any substantive view of the propriety of opioid analgesics.
That is to say, even if one maintains that the public health
problem of prescription drug abuse sufficiently justifies
curtailment of the use of opioid analgesics, it remains an
open question whether the use of opioid contracts is

102 Press Release, U.S. Senate Comm. on Fin., Baucus, Grassley
Seek Answers about Opioid Manufacturers' Ties to Medical Groups
(May 8, 2012), available at http://www.finance.senate.gov/newsroom/
chairman/release/?id=02lc94cd-b93e-4e4e-bcf4-7f4b9fae0047 (last
visited Dec. 31, 2013).

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ethically justified as a means to that end. Our position here
is that regardless of one's perspective on the merits of the
end, the universal use of opioid contracts is ethically
dubious and should be scaled back if not abandoned
entirely.