Paper for Ethics & Legal issues of nursing

Position Statement

From the *Massachusetts General

Hospital, Boston, MA; † New York

University School of Medicine, New

York, NY; ‡ Columbia University

Medical Center, New York, NY; § Seton Medical Center, Austin, TX.

Address correspondence to Paul

Arnstein, PhD, RN, FAAN, Clinical

Nurse Specialist for Pain Relief,

Massachusetts General Hospital

GRB-1034, 55 Fruit Street, Boston,

MA 02114. E-mail: pmarnstein@

partners.org

Received September 14, 2010;

Revised July 1, 2011;

Accepted September 14, 2011.

1524-9042/$36.00

� 2011 by the American Society for Pain Management Nursing

doi:10.1016/j.pmn.2010.10.033

Use of Placebos in Pain Management

--- Paul Arnstein, PhD, RN, FAAN,*

Kathleen Broglio, ANP-BC, ACHPN, CPE, †

Elsa Wuhrman, MS, FNP, BC, ‡

and Mary Beth Kean, DNP, ACNS-BC §

- ABSTRACT: The American Society for Pain Management Nursing (ASPMN) holds

the position that a placebo should not be used by any method to assess

and/or manage an individual’s pain regardless of their age or diag-

nosis. The only justifiable use of placebos is for participants enrolled

in a blinded clinical trial. These clinical trials must be Institutional

Review Board (or equivalent) approved with participants clearly in-

formed that they may receive a placebo before they consent to par-

ticipate and actually have the sham treatment administered.

� 2011 by the American Society for Pain Management Nursing

BACKGROUND AND HISTORY

Pain is a complex multidimensional phenomenon with physical, emotional, so-

cial, and spiritual aspects (Arnstein, 2010). It is universal in prevalence but

a uniquely subjective experience. Health professionals and family members are

consistently unable to precisely determine the intensity of a patient’s pain. For

these reasons, assessments of pain should be based, when possible, on the pa-

tient’s self-report. Behavioral and observational indices are reserved for use in

nonverbal or noncommunicative patients who are unable to convey their per- ception of pain (Herr, Coyne, Key, Manworren, McCaffery, Merkel, et al.,

2006). One of the ways that pain is erroneously assessed and improperly treated

is by administering placebos outside the context of an Institutional Review Board

(IRB)–approved clinical trial. Placebos administered in this manner are often in-

tended to discredit the patient’s report of pain or discomfort and cast doubt on

its validity. In these cases, it is actually the professional’s deception that defies the

precept of truth-telling.

Position statements and clinical guidelines calling for a stop to using place- bos as a method to assess and manage pain have been published and widely dis-

seminated for greater than 20 years. The federal Agency for Health Care Policy

and Research (1992), the Oncology Nursing Society, (1996), the American

Society of Pain Management Nurses (1998), the American Pain Society (1999),

and other reputable medical, nursing, and interdisciplinary organizations consis-

tently denounce the practice of placebos outside the context of clinical trials.

F€assler, Meissner, Schneider, & Linde, (2010) recently revealed an astounding pervasiveness, with the vast majority of doctors, nurses and even some care- givers treating pain and other health problems with placebos. Even more

Pain Management Nursing, Vol 12, No 4 (December), 2011: pp 225-229

226 Arnstein et al.

alarming is that some medical students are being

taught that prescribing and administering placebos is

clinically appropriate (Sherman & Hickner, 2008).

DEFINITIONS

A placebo is any sham medication or procedure de-

signed to be void of any known therapeutic value.

Placebos often take the form of sugar pills, saline in- jections, or minuscule doses of drugs expected to

have no beneficial effect based on their physical

or chemical properties (Hrobjartsson & Gotzsche,

2001).

The placebo effect is the positive response some

patients/participants experience after receiving a pla-

cebo. When present, this response has a perceptible

and measurable beneficial effect that may be subjective (e.g., pain reduction) or objective (e.g., improved

blood pressure). These effects are believed to be re-

lated to intrinsic factors (e.g., personal expectations

or learned responses) and/or extrinsic (e.g., provider,

environment, technology, and contextual) factors

(McCaffery & Arnstein, 2006).

The nocebo effect is the negative response some

patients/participants experience after receiving a pla- cebo. These effects range from minor discomforts

(e.g., headache, nausea) to life-threatening complica-

tions (e.g., cardiac arrest) (Barsky, Saintfort, Rogers,

& Borus, 2002).

An IRB-approved clinical trial is a research study

that protects human subjects from having their rights

violated. Most countries, including the United States,

have laws requiring an IRB (or similar decision- making authority) to approve all research before it is

conducted. These boards are composed of a diverse

group of at least five specially trained members who

are qualified to safeguard the welfare of human sub-

jects (National Institutes of Health, 2005). The IRB

may be within the researcher’s institution, or part of

an external group that monitors research activities

and has the authority to permit, prohibit, and stop any investigation at any time.

Informed consent is the voluntary process by

which a fully informed individual (or a surrogate deci-

sion maker) participates in making choices about

health care. Casarett, Karlawish, Sankar, Hirschman,

& Asch (2001) delineated the IRB elements of informed

consent as research study participants who: 1) are told

of the study’s design, potential benefits, and risks or burdens; 2) fully understand the information provided,

including alternatives; and 3) agree to participate in

the study voluntarily without coercion. The participant

retains the right to refuse to participate or withdraw

participation at any time without adversely affecting

the quality of care provided. This requirement includes

‘‘n-of-1’’ trials (McCaffery & Arnstein, 2006).

ELABORATED POSITION STATEMENT

In response to concerns raised by nurses in clinical

practice, the American Society for Pain Management

Nursing (ASPMN) convened a group of professionals to examine the literature, reflect on the realities of clin-

ical practice, and create a document to support the

nurse who is ordered to administer a placebo. The

morally distraught nurse who brought the issue for-

ward was put in a position of deciding between violat-

ing her own commitment to providing the best

possible treatment, and the possibility of being repri-

manded or fired for not carrying out a medical order. She is not alone, because more than one-half of nurses

sampled from 22 research studies have been asked to

administer a placebo at some point during their career

(Fassler et al. 2010).

The use of ineffective treatments violates the Pain

Management Nursing Scope and Standards of Practice

(ASPMN & ANA, 2005) which calls for all nurses to

promote the high quality of pain relief through collab- oration, facilitation of access to quality care, and inter-

vention by using methods known to control pain.

Nurses in this workgroup report firsthand knowledge

that concealed placebos are sometimes used diagnosti-

cally to determine who will and will not get access to

interventions known to relieve pain. Therefore, it is

the ASPMN position that a placebo should not be

used by any method to assess and/or manage an indi- vidual’s pain regardless of age or diagnosis. The only

justifiable use of placebos is for participants enrolled

in an IRB (or equivalent)–approved study. Those partic-

ipants will have been clearly informed before they con-

sent to participate in the study, and before actually

having the sham treatment administered, that they

may receive a placebo.

Legal and Ethical Considerations Regulatory bodies consistently affirm that patients

have basic rights when seeking health care. These in-

clude the right to receive appropriate pain assessment

and treatment. The evaluation and treatment of pain

must be commensurate with the nature of pain and

the resources available in the setting. In places where

required pain treatments are not available, patients

can be referred to other settings where pain control needs can be met (The Joint Commission, 2010).

Professional nursing standards uphold the pa-

tient’s right to receive respectful care regardless of

race, gender, age, or other medically/nonmedically rel-

evant factors. As part of their duty, nurses must protect

227Use of Placebos in Pain Management

patients from incompetent or unethical practices

(American Nurses Association, 2001). The use of place-

bos to assess and manage pain represents a failure to

demonstrate the skilled use of available methods de-

scribed in standards and guidelines regarding pain

(Agency for Health Care Policy and Research, 1992;

American Nurses Association, 2001; American Pain Society, 2008; ASPMN & ANA, 2005; Joint

Commission, 2010).

Ethical arguments could be made for using place-

bos, but they are hard to defend. The most common

ethical argument examines the conflict between benef-

icence (benefiting the patient by relieving pain) and

nonmaleficence (avoiding the potential harm of treat-

ment). This is often referred to as the principle of the ‘‘double effect.’’ This same principle could be

used to argue against placebo use, because:

1. Deceptive placebo administration is morally wrong.

2. An innocuous sham (placebo) treatment is not the saf-

est and most effective available treatment.

3. Tenuous benefits do not outweigh foreseeable harm,

including nocebo effects, uncontrolled pain, and

the loss of trust which is the foundation of therapeutic

relationships.

The deceptive use of placebos is morally wrong. It

violates the ethical principles of honesty (veracity),

trustworthiness (fidelity), and fairness (justice)

(Grace, 2006). The nurse may experience moral dis-

tress when these values are violated by a prescriber

who orders a placebo to be administered, or asks the

nurse to assist with a sham procedure while telling the patient it will relieve pain. This concealed use of

placebos violates the nurses’ duty to respect the auton-

omy and dignity of patients and protect their right to

self-determination (American Nurses Association,

2001). Nurses are uniquely situated to coordinate

and initiate crucial conversations to address the con-

flict of values when ethical dilemmas exist. Getting in-

volved parties together to engage in meaningful dialogue, though difficult, often has a positive long-

term impact.

The concealed use of placebos carries the risk of

liability for fraud, malpractice, breach of contract,

and the violation of informed consent requirements.

As health care consumers become more sophisticated,

they reject the notion that pain should be endured and

are less reluctant than earlier generations to use the civil court system when their rights to pain manage-

ment are violated (Vaglienti & Grinberg, 2004).

Although there have been cases brought against physi-

cians for improper placebo use, medical boards have

acknowledged poor judgment but declined to take ac-

tion against doctors.

Nurses, on the other hand, have been held legally

accountable when they administered placebos.

Multimillion-dollar damages have been awarded in

claims of nursing negligence; and disciplinary actions

resulting in the loss of nurses’ license to practice

have resulted from the deceptive use of placebos

(Rich, 2003; Tucker & Pasero, 2001). These cases illustrate that ‘‘following doctors’ orders’’ does not

absolve nurses from their professional duties. In

essence, the nurse who administers a placebo

deceptively is more directly involved in harming the

patient than the doctor who wrote the order.

Recommendations for Practice Nursing Practice. Nurses are often faced with con- flicting expectations from patients, families, other

health care team members, and employers (American

Nurses Association, 2001). Nurses may find it difficult

to act in a way that is consistent with their values and knowledge. Nurses may experience moral distress

when they are expected to act in a manner inconsis-

tent with personal and professional values. Even

when the nurse knows the correct course of action,

he or she may feel reluctant to take that action, owing

to a perceived lack of authority in the organization’s hi-

erarchy. The resultant moral distress can lead to emo-

tional suffering, burnout, and loss of nurses from the workforce (Corley, Elswick, Gorman, & Clor, 2001).

Actively addressing the unethical use of placebo

analgesia in clinical practice advocates for the patient

and preserves the professional integrity of the nurse,

nursing colleagues, and other health care team mem-

bers (Grace, 2006). Nurses faced with the use of place-

bos outside of the context of an IRB study should

consider taking the following steps: Identify the clinical, ethical and moral issues in the

case:

1. Clinical facts regarding pain and its effect on the

patient.

2. Placebo use is not the best choice among therapeutic

alternatives.

3. Placebo use violates the duty to alleviate pain.

4. How placebo use conflicts with the values of honesty

and providing respectful care aligned with best prac-

tices and the patient’s wishes.

Identify the resources that can support your

position:

1. Trusted colleagues, supervisors, clinical specialists, etc.

2. Patient advocates and Ethics Committee members in

your setting.

3. Policy, mission, and patient rights statements in your

setting.

4. Relevant position papers, clinical and ethical literature.

228 Arnstein et al.

Assertively communicate concerns to the pre-

scriber and your supervisor:

1. Focus on patient’s need for effective pain relief.

2. Discuss potential harm to patient, professional integ-

rity, and institution.

3. Offer reasonable clinically appropriate alternatives.

Refuse to administer placebos in the absence of in-

formed consent as part of an IRB-approved research

study.

Prescriber Practice. ASPMN urges prescribers to not prescribe placebos outside the context of an IRB- approved clinical trial. Doing so undermines the trust

needed to develop and maintain a therapeutic relation-

ship with the patient. Prescribing treatments that are

not believed to be effective not only reinforces un-

healthy notions that drugs or medical interventions

are the only way to treat discomforts, but it also wastes

valuable health care resources and exposes the patient

to potentially harmful nocebo effects. Institutional Recommendations. Establish policies to ensure that no patient will receive a placebo unless

it is in the context of an IRB-approved clinical trial. For example, the policy could state: It is the policy of

[name of organization] to prohibit the administra-

tion of placebos unless it is done within the context

of an IRB-approved clinical trial. The policy should include at least the following elements:

1. Mechanisms of reporting policy violations by a pre-

scriber or clinician, including notification of the appro-

priate supervisor/managers.

2. Delineate the appropriate venue(s) where violations of

the policy will be discussed (e.g., Ethics Committee,

Risk Management, Quality Assurance, Utilization Man-

agement, Credentialing Departments, HR Performance

Evaluations, etc.).

3. Define actions taken to censure those who prescribe

and/or administer placebos, including penalties for re-

peated violations.

4. Delineate the rationale for withholding placebos based

on current literature, position papers, policies, and co-

des of professional behavior, regulations, and evidence-

based clinical practice guidelines.

5. Protect the rights of professionals who refuse to permit

the administration of placebos.

6. Protect the anonymity of those who report the use of

placebos outside the context of an IRB-approved clini- cal trial.

7. Educate members of the IRB about the need for more

transparency in the informed consent procedures to

ensure that patients understand what a placebo is

and whether they will possibly, probably, or certainly

receive a placebo. This is necessary to protect pain pa-

tients from the physical and mental harm of unre-

lieved pain or nocebo effects.

To establish these policies and procedures,

involve key stakeholders such as:

1. Pharmacy and Therapeutics Committee.

2. Ethics Committee.

3. Risk Management/Legal Department.

4. Quality Assurance and Utilization Management profes-

sionals.

5. Credentialing Departments.

6. Clinical Practice Committees (or equivalent commit-

tees addressing the clinical practice of nurses, pharma-

cists and physicians).

SUMMARY

Placebo use for the clinical assessment and/or treat-

ment of pain represents substandard care and consti-

tutes fraud or deceptive practices. The ASPMN adamantly opposes the use of placebos outside the con-

text of an IRB-approved clinical trial. Professionals are

urged to refuse to administer placebos. Institutions

are advised to establish policies that prohibit their use

outside of a blinded IRB-approved clinical trial in which

informed consent is obtained and that support the

health care professional who upholds these policies.

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