Dermatoethics Contemporary Ethics and Professionalism in Dermatology ppt

Contents Part I Dermatologist as Clinician 1 “Excuse Me…”: Unsolicited Dermatologic Opinions: Ethical, Moral, and Legal Issues.. 1 “Excuse Me…”: Unsolicited Dermatologic Opinions: Ethi

Dermatoethics

Lionel Bercovitch • Clifford Perlis

Lionel Bercovitch, MD

Departments of Dermatology

Hasbro Children’s Hospital

and Rhode Island Hospital

Warren Alpert Medical

School of Brown University

Providence, RI, USA

Clifford Perlis, MD, MBe

Fox Chase Cancer Center

Philadelphia, PA, USA

ISBN 978-1-4471-2190-9 e-ISBN 978-1-4471-2191-6

DOI 10.1007/978-1-4471-2191-6

Springer London Dordrecht Heidelberg New York

British Library Cataloguing in Publication Data

A catalogue record for this book is available from the British Library

Library of Congress Control Number: 2011940767

© Springer-Verlag London Limited 2012

Apart from any fair dealing for the purposes of research or private study, or criticism or review, as mitted under the Copyright, Designs and Patents Act 1988, this publication may only be reproduced, stored or transmitted, in any form or by any means, with the prior permission in writing of the publish- ers, or in the case of reprographic reproduction in accordance with the terms of licences issued by the Copyright Licensing Agency Enquiries concerning reproduction outside those terms should be sent to the publishers.

per-The use of registered names, trademarks, etc in this publication does not imply, even in the absence of a specifi c statement, that such names are exempt from the relevant laws and regulations and therefore free for general use.

Product liability: The publisher can give no guarantee for information about drug dosage and application thereof contained in this book In every individual case the respective user must check its accuracy by consulting other pharmaceutical literature.

Printed on acid-free paper

Springer is part of Springer Science+Business Media (www.springer.com)

To my parents, Solomon Bercovitch and Claire and Marcus Tessler from whom I acquired my values

To my mentors and professional role models, Charles McDonald,

MD, Bencel Schiff, MD, and Manly Rubin, MD, from whom I

acquired my love of dermatology

And to my family–Anne, Deb, Rob, Rhana, Ryden, Paul, Rains, and Carol, whose love and support have sustained me through this project and make every day a joy

— LB

For my parents, Linda and Barry R Perlis, whose patience and

encouragement are limitless

For my teachers and colleagues, Charles McDonald, MD, Jonathon Merz, PhD, JD, and Stuart Lessin, MD who continue to inspire and support my academic endeavors

For the endless understanding of my wife, Emily, and love of my children, Elliot and Gabrielle

—CSP

Foreword

As a teacher of residents, a colleague of fellow academic dermatologists, and a past president of our national specialty society, I have witnessed a large array of ethical dilemmas Controversy on how to teach the issues and guide our young people regard-ing their future choices has been discussed repeatedly in forums ranging from American Academy of Dermatology forums to Association of Professors of Dermatology panels I have personally found the best method to raise consciousness

in ethical decision-making to be real life situations, issues faced in everyday clinics,

in business management, and in scholarly pursuits

Apparently Drs Bercovitch, Perlis, and co-authors in the book Dermatoethics

agree In framing each of their over 40 chapters they elect to start with a series of scenarios which illustrate the problems encountered in each area, then review relevant AMA or AAD or guidelines, speak to the appropriate ethical principles, and end with

a thorough discussion of ways each scenario might be resolved This format makes the book a relatively easy read while tackling the most challenging of issues

In sum, there is no other book like it Dermatoethics helps us prepare to face tough

decisions In prospectively considering these diverse situations we can be more cal consumers of the medical literature, models of transparency, and physicians who see the issues through the eyes of our patients It is this perspective that should guide

criti-our actions, and Dermatoethics doesn’t let us deviate from this patient-centeredness

Bravo! Read, refl ect and enjoy humanistic medicine at its best

University of Pennsylvania School of Medicine

Philadelphia, PA

Preface

What would you do if a dermatopathology laboratory offered to pay 85% of the cost

of an expensive electronic health record system for your practice? What if a patient asked you to accept an invitation to become a Facebook friend? What would you do

if you saw a lesion you suspected might be melanoma on the back of a stranger ting dressed two lockers over at the gym? And, what would you do if one of your associates began to exhibit early signs of dementia?

These are examples of the many contemporary ethical and professional dilemmas dermatologists and dermatology trainees might face in their day-to-day work The solutions are more nuanced than they may appear to be at fi rst glance Fortunately, dermatologists do not need to be trained bioethicists, healthcare lawyers, or philoso-phers to analyze and deal with such dilemmas Nor do they need to have a ready solution for every ethical dilemma encountered Dermatologists do need to recognize when an ethical issue or dilemma arises, identify key issues, assess relevant ethical principles as well as legal and professional issues, seek advice and supplementary information when indicated, and attempt to resolve the issue in a sound and satisfying way This approach is illustrated in Fig 1

Behavioral ethicists emphasize the importance of honing one’s skills in ethical analysis to avoid self-deception “When we fail to notice that a decision has an ethical

ANALYZING A PROBLEM OR DECISION

IRRESOLVABLE CONFLICT OR LAW UNCLEAR-MAY NEED COURT TO RESOLVE

JUSTIFY THE DECISION WITH SOUND

ARGUMENTS

SUBJECT THE DILEMMA TO CRITICAL ANALYSIS IDENTIFY RELEVANT LEGAL, PROFESSIONAL GUIDANCE SEEK ADDITIONAL INFO INCLUDING PATIENT’S VIEWPOINT

BREAK DILEMMA DOWN TO ITS COMPONENT PARTS RECOGNIZE EXISTENCE OF AN ETHICAL DILEMMA OR PROBLEM

Fig 1 The approach to an ethical dilemma (Adapted from p 8, Medical Ethics Today the BMA’s

handbook of ethics and law 2nd ed BMJ Books London, 2004)

x Preface

component, we are able to behave unethically while maintaining a positive

self-image,” write Max Bazerman and Ann Tenbrunsel in a recent New York Times article

(April 21, 2011, p A27) Furthermore, they add, “research shows that people

consis-tently believe themselves to be more ethical than they are … (and) that people who

have a vested self-interest, even the most honest of us, have diffi culty being objective

Worse yet, they fail to recognize their lack of objectivity.” Since all physicians have

vested self-interests, confl icts of interest are inherent in the practice of medicine

Accordingly, research suggests that even the most ethically aware physicians may not

realize their own subjectivity

This concept of this book arose from a regular seminar entitled “ Dermatoethics ” in

the Brown University dermatology residency, led by one of the editors (L.B.), that

began in 2001 At that time, our faculty recognized the irony that educational offerings

in ethics were abundant for medical students, but virtually non-existent for residents

who for the fi rst time actually have meaningful independent responsibility for patient

care Furthermore, each year the seminar identifi ed new situations refl ecting the

ever-changing medical environment Electronic communication, social networking,

health-care reform, the changing reimbursement scene, consumerism and the business of

medicine, cosmetic dermatology and medical spas, and advances in genetic

technol-ogy, all give rise to new ethical concerns These developments combined with the

frailties of human nature, to which physicians are not exempt, underscore the need for

ongoing teaching and dialogue on contemporary issues in ethics and professionalism

for dermatology trainees and practitioners

From 2001 to 2010, 136 English-language articles on ethics in dermatology were

published By contrast, there were only 98 articles published over the prior 20 years

The American Academy of Dermatology offered four forums and discussion groups

on ethics at its 2011 meeting There has clearly been increasing interest in ethical

issues in dermatology It is our hope that this book will serve as a resource to

stimu-late discussion and teaching in ethics to dermatology trainees, as well as for

practic-ing dermatologists in academia, public and military service, and the community

No work of this scope can be accomplished without the help and support of others

We wish to acknowledge the encouragement, foresight and patience of the

publish-er’s senior editor, Grant Weston, as well as the tireless work of our production editor,

Rebecca McArdle, in keeping tabs on all the contributors, chapters, permissions, and

fi gures We are also grateful for the administrative support of Allison Marshall, Dawn

Elder, and Kathy Zenszer Our contributors good-humoredly and willingly allowed

their work to be subjected to numerous edits and rewrites, and the fi nal product in no

small measure refl ects their diligence and persistence We thank Dr Antonio P Cruz

for his assistance with technological challenges, usually with little notice George

Wakeman, Esq provided insightful legal commentaries as helpful background to

many of the chapters, as nearly all the chapters did not have authors with legal

train-ing We would be remiss in failing to acknowledge the contributions of our former

residents at Brown who were the experimental group for this project (N = 37) and the

foresight of Charles McDonald, M.D., Professor and Chairman of Dermatology at

Brown University, who encouraged the establishment of this seminar course And

lastly, to our spouses and children, who sacrifi ced many hours of quality time with us

during the preparation of this book, we are grateful beyond words

Lionel Bercovitch, M.D

Clifford Perlis, M.D., MBe

Clifford Warren Lober

Defi nition of Ethics

Although we all use the term ethics (or ethical), there has been great diffi culty and lack of clarity in defi ning this term It is often used interchangeably with words such

as “good”, “right”, “acceptable”, or “ideal” Many texts defi ne ethics in terms of

“morals”, “moral life,” or “moral philosophy” [1, 2] There is, however, an inherent paradox in defi ning ethical as “moral” or “good” If, for example, one accepts the defi nition of ethical as “moral” and in turn looks up the defi nition of “moral”, one may fi nd “morality” defi ned (among other descriptions) as “a system of rules, ethics” [3] This circular defi nition both fails to clarify the meaning of either ethics or morals and, perhaps more importantly, provides absolutely no guidance for determining whether a given action is ethical or moral

If one searches for the defi nition of ethics in Black’s law dictionary, we are told to

“see legal ethics” [4] Legal ethics in turn is defi ned as “the standards of minimally acceptable conduct within the legal profession…” [5] We are again confronted with problems Are ethical standards “minimally acceptable conduct”, or are they rather ideals toward which one should aspire? Furthermore, this defi nition again gives us no basis for determining whether a given action is ethical

The following defi nition of ethics is therefore proposed: ethics is a set of

behav-ioral ideals derived from fundamental beliefs These beliefs are either (1) arbitrarily accepted as true in and of themselves or (2) derived inductively or deductively from other fundamental beliefs Let us examine this defi nition closely

Ethics represents behavioral ideals which describe behaviors and actions, not

things The moon or a tree, for example, is neither ethical nor unethical Inherent in this defi nition is the fact that these behaviors have to be the intentional actions of people A horse pulling a cart or the actions of a profoundly mentally impaired person are similarly neither ethical nor unethical

Ethics are not minimally acceptable behaviors, but rather ideals or goals to which we should strive The Code of Medical Ethics of the American Academy of Dermatology, for example, clearly presents ideals to which we should strive since it “espouses a stan-dard of behavior that is, in some cases, higher than that required by the law” [6] Our ethical actions are based upon our fundamental beliefs These beliefs are the basic bedrock, core, foundational beliefs that one holds, such as the belief in the exis-tence of God to a religious person They are beliefs, by which we mean values that

are accepted as true or the “given” in a hypothetical situation It is obviously critical

that any defi nition of ethics address how we arrive at these beliefs

There are three ways one can arbitrarily accept beliefs to be inherently tally true They can be described as self-evident or innately obvious The Declaration

fundamen-xii What Do We Mean by Ethical?

of Independence, for example, states that “We hold these truths to be self-evident , that

all men are created equal, that they are endowed by their Creator with certain

unalien-able Rights, that among these are Life, Liberty, and the pursuit of Happiness.”

[emphasis added] These truths were not scientifi cally proven or reasoned by

deduc-tive or inducdeduc-tive thinking, but were rather innately obvious to the framers of the

Declaration and accepted as fundamentally true

Divine pronouncement is another way we arbitrarily accept beliefs to be

funda-mentally correct God is perfect and therefore anything He says is accepted as

abso-lute truth Period Statements made in religious texts attributed to God are clear

examples of divine pronouncement To those who believe that “God transcends all

human reality and is without limit,” His word is absolute [7]

Finally, beliefs may be arbitrarily accepted as core values because they are

socio-biologically necessary or adaptive For example, I will probably not want to lie to you

because you may never believe me again and I will not be able to trust statements

made by you since you may now feel free to be dishonest with me Therefore, it is not

socially benefi cial for me to lie to you

Fundamental beliefs may also be derived by either inductive or deductive

reason-ing When using inductive reasoning, we generalize from a sample to a universal

value or reasoning from specifi c instances to general propositions For example,

sav-ing a particular patient’s life is ethically correct; therefore savsav-ing all patients’ lives is

ethical Alternatively, in deductive reasoning the conclusion is arrived at in a

step-by-step manner and the conclusion necessarily follows as a logical consequence of the

premises For example, the death sentence is unethical Lethal injection is a form of

the death sentence Therefore, lethal injection is unethical when used to carry out a

death sentence

Characteristics of Ethics

Ethics facilitates the functioning of society It is obvious how rejecting killing,

steal-ing, or lying as unethical promotes an orderly society As Odell stated, “Ethics is a

social phenomenon If we did not live in communities, ethics would lose its point

From the perspective of community, the goal of ethics is to make it possible for us to

live together …The production of harmonious co-existence is and must be the role of

a system of ethics” [8]

Ethics are inherently subjective If we alter our fundamental beliefs, our ethical

values change If we fundamentally believe that human life is sacred, the death

pen-alty is obviously unethical Alternatively, if we accept that society should seek “an

eye for an eye,” the death penalty would be ethical

Ethics will differ in various societies Many ancient cultures considered human

sacrifi ce to the gods to be a high honor Most contemporary Americans, conversely,

would be horrifi ed at the thought of sacrifi cing another human being for any reason

Ethics depends on the amount of detail one is given about a particular situation If

I tell you that I am going to rob a bank, you may fi nd this action unethical However,

if I tell you that I plan to commit this robbery because my children are starving and

that I have absolutely no other means of obtaining money to buy food other than

rob-bing a bank, my action may become less ethically objectionable Similarly, one may

fi nd it unethical to deny treating a patient who has a superfi cial basal cell carcinoma

However, if it is subsequently revealed that the same patient has metastatic pancreatic

cancer and has a life expectancy of only a few months, allowing the skin cancer to go

What Do We Mean by Ethical? xiii

untreated may seem far less unethical In fact, not treating the skin cancer may be the most ethical approach in this situation

Ethics is not the same as a code of laws Laws are actions taken by elected or appointed groups of persons to govern society It is not surprising, therefore, that each law may be viewed as ethical or unethical depending upon one’s beliefs If, for exam-ple, you strictly oppose abortion you will fi nd statutes permitting abortion to be highly unethical Conversely, if you support abortion the same law may be ethical in

your view One should absolutely never state either that an action is ethical because

it is legal or that a behavior is unethical because it is illegal

There will rarely be universal agreement on ethical values This is merely a refl tion that different individuals and societies will hold quite different fundamental beliefs

Ethical confl icts exist and are unavoidable One may believe, for example, that it

is ethically wrong to torture a person and simultaneously believe that human life is sacrosanct If, hypothetically, a terrorist plants a bomb in a shopping center and the only way to learn the location of the bomb and save dozens of innocent lives is to torture the terrorist, the determination of whether or not to torture the terrorist pres-ents a very obvious ethical confl ict Ethical confl icts are usually resolved by examin-ing the relative strengths of the underlying fundamental beliefs upon which the ethical actions are founded

Ethics is often communicated using concepts such as good vs bad, right vs wrong, desirable vs undesirable, or moral correctness Although these terms may character-ize ethics, they should not be used to defi ne ethics for previously described reasons Ethics changes with time due to changes in our fundamental beliefs The American

Medical Association’s 1847 Code of Ethics, for example, stated that “[i]t is

deroga-tory to the dignity of the profession to resort to public advertisements or private cards

or handbills, inviting the attention of individuals affected with particular diseases…

These are the ordinary practices of empirics and are highly reprehensible in a regular

physician” [9] [emphasis added] This statement no longer appears in the AMA’s Code of Ethics

Ethics Is Not Objectively Provable

Many people are bothered by the fact that ethics is not objectively provable, in trast to the temperature at which water boils or the distance to the moon This objec-tion, however, fades away when one considers that all knowledge, both scientifi c and ethical, is of necessity based upon assumptions

For centuries it was believed that the earth was both fl at and the center of the solar system People were burned alive at the stake for denying these very obvious “facts” Many schools still teach that there are 180° in a triangle, despite our realization that

this “fact” applies only in rare, theoretical instances where space-time is not curved

by the existence of matter [10] Dermatopathologists on a daily basis make diagnostic determinations using microscopes Although none of us would seriously dispute the existence of optical distortion in all microscopic lenses, we routinely rely on these

fl awed instruments to make “objective”, diagnostic determinations

The key point is that just as our ethics are based upon fundamental assumptions, so-called “scientifi c” or “objective” statements are similarly made based upon assumptions or beliefs As Brentano stated, “In a science it is not possible to prove every opinion which we set forth For every proof rests upon certain presuppositions;

xiv What Do We Mean by Ethical?

if we prove these, it is upon the basis of still further presuppositions But this process

cannot go on forever We cannot avoid this infi nite regress by arguing in a circle, for

then we simply explain the term in question by means of the same term, but in a

dis-guised form … Hence we must start with unproven principles, with immediate

assumptions” [11] It is similarly incorrect to discount the validity of ethical

assump-tions merely because they cannot be “scientifi cally” or “objectively” validated

Where Does This Leave Us?

Given the above defi nition of ethics and an understanding of the characteristics of

ethics, we are in a far better position to consider individual situations and make

ethi-cal determinations We know that our ethics are subjective, will refl ect our

fundamen-tal beliefs, differ among various individuals, depend upon the amount of detail we are

given, etc We clearly understand that the fact an action is legal or illegal does not

necessarily mean it is ethical It is critical that in describing any behavior as ethical

we address the fundamental underlying belief that we feel justifi es that behavior and

the reason we accept that underlying belief as true or correct Finally, we recognize

that neither ethical nor “scientifi c” beliefs are absolute

Acknowledgment

Presented in part on March 6, 2010 at the 68th Annual Meeting of the American

Academy of Dermatology in Miami, Florida

References

1 Principles of biomedical ethics 5th ed In: Beauchamp TL, Childress JF, editors

Oxford: Oxford University Press; 2001 p 1

2 Historical dictionary of ethics In: Gensler HJ, Sprugin EW, editors Lanham, MD:

The Scarecrow Press, Inc.; 2008 p xi

3 Black’s law dictionary 7th ed In: Garner BA, editor St Paul: West Group; 1999

p 1025

4 Id., p 573

5 Id., p 904

6 AAD Code of Medical Ethics for Dermatologists, 2010 http://www.aad.org/

Forms/Policies/Uploads/AR.pdf Accessed 1 Mar 2010

7 Reed ED The genesis of ethics, on the authority of God as the origin of Christian

ethics Chapter One: the authority of God: God as author Cleveland: The Pilgrim

Press; 2000 p 1

8 Odell SJ On consequentialist ethics Australia: Thompson Wadsworth; 2004 p 4

9 Code of Ethics of the American Medical Association, 1847 http://www.ama-assn

org/ama/pub/about-ama/our-history/history-ama-ethics.shtml Accessed 1 Mar 2010

10 Gueron E Adventures in curved spacetime Sci Am 2009;301:38–45

11 Brentano F The foundation and construction of ethics Chapter 1: The extent to

which principles of knowledge can be an object of investigation and controversy

New York: Humanities Press; 1973 p 14

Contents

Part I Dermatologist as Clinician

1 “Excuse Me…”: Unsolicited Dermatologic Opinions:

Ethical, Moral, and Legal Issues 3

Lionel Bercovitch

2 “Give Me Enbrel™ or Give Me Death”:

Confronting the Limits of Autonomy 9

Lionel Bercovitch

3 Direct-to-Consumer Advertising of Prescription

Medications: Misguided “Autonomy” in the Information Age 13

Lisa Pappas-Taffer and Alexander Miller

4 Autonomy, Isotretinoin and iPLEDGE:

The Ethics of Burdensome Regulation

and Use of Teratogenic Medication 19

Kenneth E Bloom and Lionel Bercovitch

5 “Who Speaks for the Child?” Consent, Assent,

and Confi dentiality in Pediatric Dermatology 25

Kenneth E Bloom and Lionel Bercovitch

6 Therapeutic Privilege: If, When, and How to Lie to Patients 33

Richard G Fried and Clifford Perlis

7 Communicating with Patients About Adverse

Medical Events: If, When, and How to Say “I’m Sorry” 37

Steven Shama, Lyn Duncan, and Lionel Bercovitch

8 The Computer Will See You Now: Ethics of Teledermatology 45

Jennifer L Weinberg, Rachel H Gormley, and Carrie L Kovarik

9 Hospital Consultations: Embracing

Professionalism Even When It Hurts 51

Lauren E Krug and Stephen E Helms

10 The Extender Is In: Delegating Ethically—Ethical

and Professional Issues Relating to Physician

Extenders in Dermatology 55

Steven Rosenberg and Clifford Perlis

12 Taking Care of Uncle Bob’s Rash:

Should One Treat Family Members? 67

Sandra Osswald

13 Peering into the Gift Horse:

Is It Ethical to Accept Gifts from Patients? 71

Lionel Bercovitch

14 The Dermatologist and Social Media:

The Challenges of Friending and Tweeting 77

Jennifer A Sbicca and Stanton K Wesson

15 Respecting Differences: Dermatology in a Diverse Society 83

Vimal Prajapati and Benjamin Barankin

16 Dermatologists Within, Beyond

and Struggling with Borders: The Global Dermatologist 91

Jennifer L Weinberg

17 Feet of Clay: The Impaired Dermatologist 97

Brandon H Krupp

Part III Dermatologist as Teacher and Trainee

18 The Mentor-Mentee Relationship: The Devil Is in the Details 109

Kimberly L Merkel, John A Cole, and Stanton K Wesson

19 Tales from the Residency Interview Trail 113

Jennifer A Sbicca and Alfred T Lane

20 Ethics Education for Residents:

Growing Pains and Learning Crises 119

Irèn Kossintseva and Benjamin Barankin

21 Teaching Ethics in Clinic: Keeping You Smart and Honest 125

Nely Z Aldrich and Eliot N Mostow

Part IV Dermatologist as Businessperson

22 Boutiques, Botox ® , and Basal Cells:

Can Dermatology Set Its Priorities? 131

Jeffrey J Meffert and Maria Villegas

23 The Price Is Right:

Offi ce Dispensing and Product Pricing 137

Tivon Sidorsky

Contents xvii

24 My Elixir, MD:

Morphing a Medical Degree into a Skincare Brand 143

Julie Cantor

25 Marketing the Physician: From Antitrust to Distrust 147

Catherine L Kowalewski and Jeffrey J Meffert

26 What the Market Will Bear?

Ethical and Professional Issues in Medical Fees 153

Carl Johnson and Lionel Bercovitch

27 Spa, MD: When Dermatology Meets Aromatherapy 157

Tivon Sidorsky and Lionel Bercovitch

28 Gatekeepers, Dermatologists, and Their Patients:

Mixed Messages in Managed Care 163

Lindsey A Brodell, Robert T Brodell, and Brendan Minogue

29 Ethical Adventures in 21st Century Dermatopathology 169

Homer O Wiland IV, Barry D Kels, and Jane Grant-Kels

30 Defi ning the Gray Zone:

Client Billing and Contractual Joint Ventures 177

Homer O Wiland IV, Barry D Kels, and Jane Grant-Kels

31 No Strings Attached? Managing Confl icts

of Interest in Medicine 185

Noah D Shannon and Clifford Perlis

Part V Dermatologist as Scholar

32 Respecting Human Subjects:

Responsibilities of the Clinical Investigator 193

Kenneth Katz and Samual Garner

33 Hope, Hype, and Genotype:

Genetic Testing in Dermatological Diseases 197

Natasha Shur

34 Desperate Measures for Desperate Patients:

Translational Research in Epidermolysis Bullosa 205

Alfred T Lane

35 Reading Between the Lines:

Can Peer Reviewers Be Expected to Detect Fraud? 215

Jason D Gillum, Jeffrey D Bernhard, and Robert P Dellavalle

36 Hiding Behind the Curtain:

Anonomyous Versus Open Peer Review 221

Andrea L Suárez, Jeffrey D Bernhard, and Robert P Dellavalle

xviii Contents

37 Ghost Busting in Dermatology Publications:

Providing Byline Integrity 227

Andrea L Suárez, Jeffrey D Bernhard, and Robert P Dellavalle

38 Telling the Same Tale Twice:

Déjà vu and the Shades of Grey in Self-Plagiarism 233

Andrea L Suárez, Jeffrey D Bernhard, and Robert P Dellavalle

39 Cutting Edge or Cutting Corners? Innovative Care 237

Jolion McGreevy and Clifford Perlis

Index 241

Part I Dermatologist as Clinician

L Bercovitch and C Perlis (eds.), Dermatoethics,

DOI 10.1007/978-1-4471-2191-6_1, © Springer-Verlag London Limited 2012

Case 1 (below) What would say if you saw this on

your daughter’s best friend?

Case 2 (below) What would you do if you saw this

lesion on the arm of a complete stranger in the health club locker room?

L Bercovitch

Department of Dermatology , Warren Alpert Medical School

of Brown University , Providence , RI , USA

4 L Bercovitch

Case 3 (below) What would you do if you saw this

on the fi nger of the barista serving you coffee at

Starbucks?

Case 4 (below) What would you do if you were

standing next to this person at the subway station while

waiting for a train?

Case 5 (below) Would you say something if you

saw these lesions while a mother was changing her baby’s diaper at the beach? Would it be different if the mother were a family friend?

Discussion

When is a dermatologist not a dermatologist? On tion? At a family gathering? While exercising at the gym? At the theater or waiting for a subway? In reality, never Dermatologists are skillful trained observers Even without the “antenna raised”, they observe lesions and rashes on friends, relatives, and even complete strangers that in the context of an established doctor–patient relationship would demand attention and action, possibly urgently But what should the derma-tologist do when individual in question is not a patient and has not sought the doctor’s opinion? Should he or she offer an unsolicited diagnosis or advice? What if the consequences of inaction could be serious or even fatal for the “patient”?

1 “Excuse Me…”: Unsolicited Dermatologic Opinions: Ethical, Moral, and Legal Issues

Although offering an unsolicited medical opinion

may be regarded as an act of benefi cence, the

physi-cian does not have a strict moral obligation to do so

[ 1] On one end of the spectrum are conditions or

actions that are well recognized as being harmful but

that pose no immediate threat to the individual, such as

obesity, smoking, excessive sun exposure or indoor

tanning On the other end are urgent, life-threatening

emergencies such as an accident or cardiac arrest In

the former, the physician is not morally bound to offer

his opinion or to take action while in the latter, the

phy-sician is professionally and morally bound to act In

the situations in between, in which the obligation of

benefi cence may exist, the physician may use his or

her discretion in deciding how, when, or even whether

to offer an unsolicited opinion [ 1 ]

The degree to which the physician is morally

obli-gated to act is affected by the seriousness and urgency

of the risk to the individual, the degree of certainty of

the diagnosis, and the presumption that the stranger

would want the physician’s opinion or intervention [ 1 ]

The more serious the consequences of inaction, the

less certain the diagnosis needs to be before acting

The obligation to bring a diagnosis to someone’s

attention also depends on how obvious it is to that

indi-vidual that something is wrong In addition, one cannot

assume that the person either knows how to access

medical care or that the condition is even treatable

Unless the problem is treatable, there should be no

obli-gation to offer an unsolicited opinion [ 1 ] Indeed,

offer-ing an unsolicited diagnosis for a condition that is

untreatable or for which no benefi cial intervention

exists could confl ict with the physician’s obligation of

non-malefi cence were the patient to suffer

psychologi-cal distress or act in a self-destructive way

A latent diagnosis that may remain so before

caus-ing harm imposes greater moral obligation upon the

dermatologist The bystander physician should possess

appropriate medical knowledge to render an opinion,

but need not be a specialist in the fi eld A psychiatrist

can suspect a melanoma [ 2 ] and a dermatologist can

recognize exophthalmos as a sign of Graves’ disease

or suspect a potential cardiac emergency

Even where there appears to be a professional

obliga-tion or duty to offer unsolicited advice, ordinary morality

(such as “don’t invade someone’s privacy”) may clash

with professional morality (the obligation to heal the sick

and relieve suffering) One’s personal morals and ethics

may confl ict with one’s professional duty and ethics [ 3 ]

Ratzan [ 3 ] has described the “bystander non” as it applies to medical emergencies, summarized

phenome-in Table 1.1 Even so, the likelihood of the “bystander” taking action may depend on the number of bystanders, so-called “diffusion of responsibility” [ 3 ] , to which any-one who has been present at a cardiac arrest can attest The bystander role can be ambiguous How severe or urgent is the situation? Is there a threat of harm increas-ing with time and resulting from the bystander’s inac-tion? What are the bystander’s ethical obligations? A professional is no ordinary bystander by virtue of tech-nical or medical expertise and professional duties An ordinary bystander may be a Good Samaritan while a physician’s professional duty may create an obligation

to stop and assist regardless of private morals To what degree this applies to rashes and skin lesions is less clear than with a serious motor vehicle accident

Having any sort of relationship with the individual may make it easier and seemingly less intrusive to offer a diagnosis or opinion It is easier to strike up a conversation with someone with whom one has even a passing acquaintance In addition, if the physician knows the individual, it might even make it possible to have a closer look at the lesion or rash without seeming overly intrusive

As with any intervention, there are risks and benefi ts

to be considered These are summarized in Table 1.2 Intervention by the bystander physician can have unin-tended and unexpected consequences For example, consider the following scenario The physician notices

a pigmented lesion on someone’s back at the beach and comments that it looks a bit worrisome and recom-mends that it be examined by a dermatologist The per-son goes to his physician who remarks, “you’re lucky someone noticed that It could have been very serious

or even fatal if the diagnosis had been delayed a few more months” On the other hand, consider a different scenario: The same person goes to the dermatologist who tells him the lesion is nothing to be worried about Based on the initial impression of the doctor at the

Table 1.1 The bystander phenomenon

1 The bystander must notice that something is happening

2 Bystander recognizes it as an emergency or crisis demanding

a response

3 Bystander attributes to self responsibility for acting

4 Bystander must decide on effective intervention

5 Bystander must decide how best to intervene

Source : From Ratzan [ 3 ]

6 L Bercovitch

beach, the patient is not fully reassured and insists on

having the lesion removed The wound dehisces,

becomes infected, and heals with unsightly keloid scar

The two scenarios illustrate some of the potential risks

and benefi ts of unsolicited diagnosis

Legal Issues*

Ethical and moral issues need to be considered in light

of legal considerations Without obligation imposed by

law, the dermatologist bystander has no legal duty to act

regarding another person, as opposed to a moral

obliga-tion or professional duty The law offers little guidance

in this area The mere act of intervention, however,

cre-ates a legal duty to act in a reasonable manner The

whole area of unsolicited diagnosis and opinion is a gray

area legally because the physician’s legal duty to act is

not created until there is a professional relationship

Once the physician intervenes, duty is created and

obli-gations are imposed, the extent depending on the facts of

the case Exactly what those duties are in the case of an

unsolicited diagnosis (as opposed to cardiopulmonary

resuscitation or other urgent interventions) are unclear

However, generally a doctor-patient relationship does

not exist until both parties agree to enter into one

Good Samaritan statutes have traditionally been

associated with emergencies and differ signifi cantly

from state to state In general, these laws immunize the

physician from being used for acts of negligence but

not “gross negligence” or willful, wanton, or reckless

acts (which, parenthetically, would likely not be

cov-ered by malpractice insurance, either) It would be

extremely rare, however, for a physician’s action in a Good Samaritan situation to rise to the level of gross negligence or involve intentional infl iction of harm Whether or not Good Samaritan laws would protect the dermatologist offering an unsolicited opinion is uncer-tain Strictly speaking, “liability” requires a doctor–patient relationship, and offering unsolicited advice does not meet the legal defi nition of a doctor–patient relationship Whether that is affected by the patient act-ing on such advice is a gray area

Analysis of Case Scenarios

We shall now consider the case scenarios presented at

the beginning of a chapter In case 1 , the presence of a

severe sunburn, while a well-known risk for skin cancer, does not pose an imminent danger to the son’s best friend In addition to the embarrassment likely to be infl icted on the dermatologist’s daughter by offering her friend his unsolicited opinion or advice, it is likely that the sunburned recipient would not welcome it Although the offer of advice may be an act of benefi -cence, the lack of immediate benefi t as well as the invasion of privacy and social embarrassment created would not justify it If the sunburned individual were one’s fi ancée or niece, then perhaps it might be viewed

as less intrusive and be more graciously accepted

Case 2 is somewhat more analogous to the situation

of a serious accident in that a malignant melanoma is suspected How certain the dermatologist is of the diagnosis might infl uence how comfortable he or she is about offering advice or a diagnosis Having some relationship with the individual having the lesion might also make it less awkward Although the risk of harm might not be imminent, that is impossible to gauge on

a cursory look, and in any case, if the differential nosis includes malignant melanoma, the outcome might very well be fatal The dermatologist has a pro-fessional duty to act that likely transcends his or her personal mortality If one would be grateful for an early and fortuitous diagnosis of melanoma for one-self, then the risk of invading another’s privacy and causing possibly needless anxiety is justifi ed

Case 3 is more problematic As in case 2, the differential diagnoses include malignant melanoma The same considerations as in case 2 should apply However, it is much more diffi cult to diagnose visually and the diagnostic workup is potentially more invasive

If one is a regular customer at the local Starbucks and

Table 1.2 Benefi ts and risks of unsolicited opinions

Benefi ts

1 Benefi cence: physician-bystander has acted for the benefi t

of the recipient

2 May prevent serious consequences of untreated diagnosis

by enabling timely intervention

3 Physician has fulfi lled a professional duty

Risks

1 Diagnosis may be incorrect For pigmented lesions, there is

a high probability of misdiagnosing malignant melanoma

2 Unnecessary, costly and potentially invasive investigations

with potential morbidity The risk is inversely proportional

to the accuracy of the diagnosis

3 Anxiety and depression may result

4 Recipient may be stigmatized

5 Invasion of privacy

Source : Adapted from Ratzan [ 3 ]

1 “Excuse Me…”: Unsolicited Dermatologic Opinions: Ethical, Moral, and Legal Issues

has seen the barista frequently enough to strike up a

conversation, it might be possible to offer unsolicited

advice that is not perceived as being intrusive as it

might otherwise be However, the potential risks in this

situation are greater

Case 4 involves a very obvious mutilating lesion It is

impossible to imagine that the individual involved is

unaware of the lesion or the potential gravity of the

situa-tion It is possible that the person might not have access to

health care due to lack of resources, in which case

diplo-matically and sympathetically offered unsolicited advice

might be graciously and even gratefully received, but it is

very likely to be rejected or not acted upon, especially if

there is signifi cant underlying mental illness The

profes-sional duty to intervene in this very serious situation is

probably mitigated by the advanced and untreatable

nature of the lesion and the fact that the affected

individ-ual almost certainly is or has been made aware of it

Case 5 involves an infant with multiple café au lait

macules suggestive of NF-1 neurofi bromatosis The

disease is genetic and not treatable The main

advan-tages of early diagnosis are timely surveillance for

optic pathway gliomas, early intervention for cognitive

or learning disabilities, and possibly genetic

counsel-ing for his parents prior to future pregnancies However,

one could reasonably assume that the infant’s

pediatri-cian would sooner or later appreciate the signifi cance

of the café au lait macules and refer the child for

evalu-ation If the mother is someone familiar to the

derma-tologist, suggesting further evaluation might not be as

likely to be perceived as intrusive or an invasion of

pri-vacy, but even in similar situations, good intentions

can destroy relationships [ 4 ]

How to Offer Unsolicited Advice

or Diagnosis [ 3 ]

Offering unsolicited advice or diagnosis is fraught with

diffi culty It should be done discretely, tactfully, and

qui-etly in a private setting The physician or dermatologist

should identify one self as such, and not solicit the

indi-vidual as a patient One should never act or be perceived

as being overly certain of the diagnosis Refer the

indi-vidual to his or her primary care physician or to the

appro-priate institution or specialist for follow-up Reassure the

stranger that your motives are not self-serving or fi

nan-cial, and that the diagnosis under such circumstances is

by necessity imperfect and preliminary and is subject to

error Keep the encounter confi dential afterward

Conclusion

Virtually every dermatologist has seen something on a stranger or family member or friend that has aroused some concern, causing the physician to agonize over whether or not to say something Table 1.3 summarizes the conditions under which offering an unsolicited opinion might be appropriate

Interestingly, lay individuals (although not a ity) are more likely than medical professionals to believe that unsolicited medical advice or intervention

major-is appropriate, and a signifi cant majority of physicians would not be inclined to intrude on a patient’s privacy

to offer a diagnosis of suspected malignant melanoma [ 5 ] Benefi cence, non-malefi cence, and respect for the individual’s privacy should guide the dermatologist, but in the end, one should also be guided by how one would want to be treated in the same situation

*Acknowledgments The author wishes to acknowledge the advice and counsel of George E Wakeman, Jr., Boston, MA regarding the legal aspects of unsolicited medical advice I am indebted to Manly Rubin, MD for case scenario 1

References

1 Moseley R Excuse me, but you have a melanoma on your neck! Unsolicited medical opinions J Med Philos 1985;10(2): 163–70

2 Schildkrot B Am I looking at a malignant melanoma? New York Times April 1, 2008

3 Ratzan RM Unsolicited medical opinion J Med Philos 1985;10(2):147–62

4 Marion RW Genetic drift: the unsolvable puzzle Am J Med Genet 1996;62(4):327–9

5 Zwitter M, Nilstun T, Knudsen LE, Zakotnik B, Klocker J, Bremberg S, et al Professional and public attitudes towards unsolicited medical intervention BMJ 1999;318(7178):251–3

6 Mitchell EW The ethics of passer-by diagnosis Lancet 2008;371(9606):85–7

Table 1.3 Conditions for offering unsolicited advice

1 Physician assesses probability of potentially serious disease

4 Physician is reasonably certain of diagnosis

5 Recipient would likely want to know diagnosis

6 Problem is potentially treatable

Source : Adapted from Ratzan [ 3 ] and Mitchell [ 6 ]

L Bercovitch and C Perlis (eds.), Dermatoethics,

DOI 10.1007/978-1-4471-2191-6_2, © Springer-Verlag London Limited 2012

A 40-year-old man presents with plaque psoriasis limited

to the hairline, elbows and knees He is troubled by the

cosmetic appearance but dislikes the greasy feel of

topi-cal medications as well as the need for regular

applica-tion to control the disease He also complains of right

knee pain when he jogs His father had severe psoriasis

that limited his career in public relations He has heard

about etanercept (Enbrel™, Wyeth Amgen) and

adali-mumab (Humira™, Abbott) in media advertisements

and wants a prescription for one of these biologics

because of their published effi cacy and infrequent

administration

You discuss treatment options and quote from the

Food and Drug Administration (FDA)-approved

pack-age insert that these biologic therapies are approved

for “patients with moderately severe plaque psoriasis

who are candidates for systemic treatment or

photo-therapy and when other systemic therapies are

medi-cally less appropriate” [ 1 ] You explain that for this

reason, you do not feel it is medically appropriate to

prescribe either of these medications for him The

patient counters that your decision shows lack of

respect for his autonomous medical decision-making

and that it refl ects a paternalistic style of doctoring not

appropriate for the Internet era

Case 2

A 16-year-old male presents demanding that all his moles

be removed He is self-conscious and does not want to be seen by others without his shirt on He has several clini-cally benign compound and dermal nevi on the face, neck, and back Because several of these nevi are located

on areas at risk for hypertrophic scarring and considering the lack of medical indication for removal, you express your reluctance to remove the moles He insists that if you

do not do it, he will fi nd someone who will His parents feel confl icted between considering their son’s wishes and psychological wellbeing and what they perceive to be common sense and your good medical judgment

Case 3

A 50-year-old woman presents for consultation regarding wide excision of a biopsy confi rmed radial growth phase 0.1 mm thick superfi cial spreading malignant melanoma

of the calf She has read about sentinel lymph node biopsy (SLNB) and staging workup on the Internet and is insis-tent on having SLNB, magnetic resonance imaging (MRI) and positron emission tomography (PET)

Unreasonable Demands for Care

The literature on end-of-life care is replete with ings on unreasonable demands for medical interven-tion, usually referred to as futile care In most

writ-ambulatory specialties, including dermatology, futile

does not adequately describe clinically inappropriate demands These are more aptly classifi ed in Table 2.1

L Bercovitch

Department of Dermatology , Warren Alpert Medical School

of Brown University , Providence , RI , USA

e-mail: lionel_bercovitch@brown.edu

10 L Bercovitch

The concept that patients should actively participate

in decisions regarding their medical care and that they

should have as much information as possible to assist

them in the process is central to patient autonomy

Indeed, there is a vast amount of information available

in print and electronic media, much of it unfi ltered and

not subjected to expert peer review Patients often

assume the role of consumers of a commodity both in

their expectations of the healthcare system and in their

medical decision-making The collision of an

empow-ered patient with an a profusion of online health

infor-mation can create the perfect storm of inappropriate

demands for treatment or tests

In the past, physicians often assumed a more

paternalistic role, presenting the patient with only the

doctor’s recommended choice of intervention Current

practice recognizes that patients are in the best

posi-tion to understand their needs and personal values and,

equipped with information and knowledge of their

options, to factor these into shared medical

decision-making

Nevertheless, there is no absolute moral right to

access any medical intervention that the patient desires

There is no moral basis to require health care providers

to compromise professional integrity and standards to

provide treatment or testing that they feel are

medi-cally unnecessary or potentially harmful or useless,

just because a patient demands it Also, third parties

such as insurers and government entities may affect

medical decision-making through their decisions

whether or not to pay for the interventions

In addition to autonomy, other core ethical values,

including benefi cence, non-malefi cence, and distributive

justice- are involved in dealing with unreasonable

demands for care Physicians are morally obligated to

act in a manner that benefi ts patients and avoids harm

Resources, both technological and fi nancial, are fi nite Healthcare providers have an obligation to utilize resources wisely and minimize waste in order to maxi-mize society’s access to medical care

Physicians are expected to exercise good as well

as independent medical judgment in patient care If physicians routinely acted against their better judg-ment because of external demands, the public’s trust in the profession would erode In addition, acceding to patient requests does not relieve physicians of medi-colegal liability or allegations of criminal responsibil-ity if adverse outcomes occur [ 2 ]

Professionals are not required to violate their sional standards or break the law at the behest of their clients In this respect, there are dual loyalties The mere fact that most treatments and tests require authorization

profes-of a licensed physician and that peer review tions and jurisdictional licensing boards regulate medi-cal practice attests to society’s expectations of physicians The Council on Ethical and Judicial Affairs of the American Medical Association states “physicians are not obligated to deliver care that in their best profes-sional judgment will not have a reasonable chance of benefi tting their patients Patients should not be given treatments simply because they demand them” [ 3 ]

Analysis of Cases

In Case 1 , the patient is demanding therapy that is

not indicated (and is possibly contraindicated) (see Table 2.1 ) It would certainly be reasonable to tailor a topical regimen more compatible with the patient’s sensory preferences or to recommend alternative modalities for localized psoriasis such as the 310 nm excimer laser He could (and probably should) be referred to a rheumatologist to evaluate his complaints

of knee pain Of course, the patient may then bring the same demand to the rheumatologist, who might feel that an oral non-steroidal anti-infl ammatory agent would be the preferred treatment

In this case, the patient has localized psoriasis that can be managed by other modalities that are safer and less expensive than biologic therapies While the high cost of biologic drugs might very well enter into the discussion and decision-making, the dermatologist should avoid creating the impression that bedside rationing is the basis for the decision Treatment should

be recommended based on appropriateness, treatment

Table 2.1 Unreaso nable or inappropriate demands for care:

When futile is not the right word

NOT INDICATED : Outside practice guidelines or expert

opinion

CONTRAINDICATED : In addition to possible lack of

indication, treatment carries risk of harm

INAPPROPRIATE : Clinical judgment indicates that the

treatment has little value or that the risks likely outweigh the

benefi ts

UNNECESSARY : Treatment offers little or no chance of

benefi t, or the condition is self-limited and benign without

intervention

Source : Adapted from Brett [ 8 ]

2 “Give Me Enbrel™ or Give Me Death”: Confronting the Limits of Autonomy

guidelines, and good clinical practice Physicians have

an obligation to allocate scarce resources appropriately

and fairly, and therefore cost might enter into the

deci-sion, particularly when a third party is paying the cost,

but the physician’s primary professional duty is to the

wellbeing of the patient

Alternatively, the physician could decide that it is

easier and less confrontational to honor the patient’s

demands and prescribe etanercept or adalimumab The

problem with this course is that if the patient is harmed

by a side effect of the treatment, the dermatologist would

have little defense against having chosen a treatment for

which there is a lack of indication both under practice

guidelines and the FDA-approved manufacturer’s

pack-age insert Although our legal system recognizes the

patient’s right to self-determination, i.e what can be

done with one’s body, sound decision-making is the best

defense against malpractice liability [ 4 ] , p 49]

The patient in Case 1, who has a chronic skin

condi-tion, may feel a need for some sort of control of the

disease process and its treatment, as well as a need to

have his preferences and autonomy validated by the

dermatologist If the dermatologist fails to recognize

the patient’s role in medical decision making, address

his demands and understand where they are coming

from, the patient is likely to mistrust the physician,

dis-regard his or her advice, and seek care elsewhere until

he fi nds what he is looking for By listening to the

patient’s preferences, the patient’s concerns about his

father’s disabling psoriasis can be elicited and

vali-dated, and the dermatologist can address the fact that

therapy with a biologic agent does not affect the

natu-ral history of the skin disease

Paternalism occurs when benefi cence and what the

physician thinks is best for the patient takes priority

over autonomy and the patient’s desires and values It

is what happens when medical decision-making is a

one-way street rather than a shared process [ 4 ] , p 50,

5 ] , pp 176–93] Although, as the patient points out, it

is not acceptable in contemporary practice, it can be

ethically justifi ed when patients lack capacity to make

informed decisions (although sharing decision-making

with a health care proxy might be viewed as the

appro-priate course) or if the risk of harm outweighs any

likely benefi t or the patient’s demand falls outside of

accepted standards of medical practice

In Case 1, the patient who wishes more control in

medical decision-making accuses the dermatologist of

being paternalistic despite the fact that the physician has

made a good faith effort to validate the patient’s wishes and to propose an alternative, safer approach that is both clinically and economically appropriate, without pre-cluding future consideration of biologic therapy if clini-cal circumstances warrant If the patient continues to be unreasonable in his demand for care in this non-life threatening condition, the physician would be justifi ed

in advising the patient to seek care elsewhere

Case 2 is complicated by the fact that the patient

has not reached the age of majority and legally lacks standing to give informed consent Although physi-cians tend to respect the autonomy of adolescents as near adults, especially as they approach the age of majority (18 in the US and Canada), adolescents often live in the present with a limited grasp of the future, care about things out of proportion to their actual importance, may be disproportionately infl uenced by perceived peer impressions, and fail to recognize the long-term consequences of their decisions Indeed, adolescence shares features of childhood and adult-hood, and adolescents are risk-takers Even if the ado-lescent had the legal standing to give informed consent, for example, as an “emancipated minor”, the physician

is not obligated to suspend professional judgment to satisfy the patient’s demands By validating the patient’s concerns in a nonjudgmental way, thoroughly detailing the risks and benefi ts of the surgical proce-dure, involving both the patient and parents (while focusing on the patient) in the decision, the petulant and demanding behavior of the teenaged patient can hopefully be channeled into constructive decision-making In addition, the economic reality of lack of insurance coverage for an essentially cosmetic proce-dure might also temper the patient’s demands (or cer-tainly affect how the parents feel) A satisfactory compromise might be to agree to excise one or two nevi to allow the patient, parents, and physician to assess the cosmetic outcome before proceeding with further procedures, recognizing that a good (or bad) result does not guarantee identical results in future procedures

Case 3 has many features in common with Case 1

The patient has read about SLNB, MRI, and PET ning on the Internet and regards these as the current standard of care for malignant melanoma Her expecta-tion of the best and most up-to-date in therapeutic and staging procedures is undoubtedly infl uenced by the anxieties, fears, and uncertainties that accompany the diagnosis of a malignancy In this case, the physician

scan-12 L Bercovitch

should validate and recognize the patient’s concerns and

fears while at the same time reassuring her of the

excel-lent prognosis of radial growth phase melanoma and the

curability by wide excision alone If the patient is

obsessed with concerns about metastatic disease and

wants these interventions for reassurance, then it is

incumbent on the physician to explain the limitations of

negative SLNB or medical imaging The physician

should also present current information on the role of

SLNB as a staging procedure and present data that it has

no effect on survival [ 6, 7 ] , which in her case is likely to

approach nearly 100% with or without it, as well as the

potential morbidity of the procedure If despite these

explanations as well as an explanation regarding the

lack of necessity for staging for such a thin melanoma as

well as the very real risk of incidental fi ndings whose

workup may also have morbidity and unintended

conse-quences, the patient is not persuaded of the lack of

indi-cation (if not contraindiindi-cation) for these procedures,

then the physician should suggest a second or multiple

opinions before the patient proceeds

Conclusion

Medical decision-making should as much as possible be

a shared process between the physician and patient A

successful physician-patient partnership is built on trust

and is compromised by a paternalistic attitude on the part

of the physician that fails to validate and recognize the

patient’s requests (or demands) and understand the

underlying basis for these However, there are limits to

autonomy Physicians have professional standards and a

duty to educate their patients and legal as well as

con-tractual obligations to uphold Furthermore, all resources

have fi nite limits Information is not knowledge Knowledge without experience and clinical judgment is not wisdom The skilled dermatologist must somehow temper unrealistic or unreasonable demands from patients armed with reams of information with that wis-dom and reach a mutually acceptable decision that engenders trust and hopefulness In a situation in which the inappropriateness of the request is not so clear-cut, the dermatologist has an obligation to weigh heavily the patient’s wishes and values in making a shared decision

Acknowledgment The author wishes to acknowledge the contribution of Case 1 by Thomas P Long, M.D

4 Jonsen A, Siegler M, Winslade W Clinical ethics 5th ed New York: McGraw-Hill; 2002

5 Beauchamp T, Childress J Paternalism: confl icts between benefi cence and autonomy In: Principles of biomedical eth- ics 5th ed New York: Oxford University Press; 2001

6 Stebbins WG, Garibyan L, Sober AJ Sentinel lymph node biopsy and melanoma: 2010 update Part II J Am Acad Dermatol 2010;62(5):737–48; quiz 749–750

7 Stebbins WG, Garibyan L, Sober AJ Sentinel lymph node biopsy and melanoma: 2010 update Part I J Am Acad Dermatol 2010;62(5):723–34; quiz 735–726

8 Brett A Inappropriate requests for treatments and tests In: Sugarman J, editor 20 common problem: ethics in primary care New York: McGraw-Hill; 2000 p 3–11

L Bercovitch and C Perlis (eds.), Dermatoethics,

DOI 10.1007/978-1-4471-2191-6_3, © Springer-Verlag London Limited 2012

3

Direct-to-Consumer Advertising

of Prescription Medications:

Misguided “Autonomy”

in the Information Age

Lisa Pappas-Taffer and Alexander Miller

Practicing physicians, including dermatologists, can

expect an average of ten specifi c drug requests per

week from patients Much of the increase in patient

demand for prescriptions is fueled by direct-to-

consumer drug advertising (DTCDA) in mass media

[ 1 ] which has accelerated over the past 10–15 years to

account for a signifi cant portion of the amount spent

on drug promotion In fact, the rise in prescriptions for

the drugs most heavily advertised to patients has far

outstripped the rise in all other prescriptions during

this period [ 1 ] This chapter reviews the basic concepts

of DTCDA, evaluates current data in the literature

regarding its impact on the physician-patient

relation-ship, highlights ethical issues that arise from DTCDA,

and provides recommendations for responding to

patients requesting prescriptions for medications they

have seen advertised

Case 1

A new patient to the dermatologist states: “My psoriasis

is ruining my life I am 20-years-old and I have

head-to-toe psoriasis I avoid going to social events and I’m

ashamed of the fl akes of skin I leave everywhere My

previous dermatologist would not give me steroid

creams for fear of side-effects and my liver labs became too high on methotrexate I simply do not have time for phototherapy given my work schedule I saw this ad on

TV for an injection for psoriasis Will you please scribe it for me? I want to start enjoying my life.”

The patient shows the dermatologist an ad for an injectable psoriasis medication on her laptop computer

A young attractive woman is seen in the entryway of her house in a bikini top and shorts Grabbing a towel and sandals, she smiles to herself as she catches a glimpse of her refl ection in the mirror, before running outside to a jeep full of attractive, smiling peers In the next scene, the jeep arrives at a sandy beach As she confi dently removes her cover-up and runs to the water with friends, the narrator states, “This medication may increase your risk of cancer.” With the sun setting over the water and the patient walking arm-in-arm with an attractive male, the narrator lists other side effects

Case 2

A 33-year-old female patient explains: “I saw this ad in a magazine for a natural medicine for genital warts I have avoided becoming intimate with my new boyfriend because of my warts I am also getting older and I want

to have children I am worried about medications ing birth defects, so I try to use only natural medications Will you prescribe this new natural medicine for me?”

The patient unfolds a glossy magazine ment featuring a young woman The accompanying text states: “A drug that utilizes the therapeutic power

of nature to rid genital warts for good.” The ment then refers the reader to the manufacturer’s web-site for further information

L Pappas-Taffer ( )

Department of Dermatology , Warren Alpert Medical School

of Brown University , Providence , RI , USA

e-mail: lisakpappas@gmail.com

A Miller

Department of Dermatology , University of California Irvine ,

Irvine , CA , USA

14 L Pappas-Taffer and A Miller

Case 3

A 26-year-old woman thanks you for overbooking her

into your schedule and explains, “The dark hair on the

side of my face is driving me crazy! My mom and

sis-ters all have the same thing It isn’t normal Let me

show you this commercial for a cream that is supposed

to help.”

She opens her laptop computer to show you an

advertisement where two young women are seen

wash-ing their hands at adjacent sinks in a restroom at work

One is an attractive confi dent woman, the other a timid

younger woman The confi dent woman looks over at

her co-worker’s arms and states, “You have arm hair

like a man! Why don’t you do something about that?”

Another woman exits a stall as the confi dent coworker

leaves the bathroom, opens her purse and shows the

distraught hirsute woman a tube of cream and says,

“You’re not alone.” At the end of the commercial

a similar scenario unfolds, with a different female

washing her hands Next to her is the previously timid

hirsute woman—now confi dent, well dressed, and with

hairless arms She looks over at her neighbor’s arms,

smiles, hands her the tube of cream, and states, “You’re

not alone”

Discussion

Direct-to-consumer drug advertising (DTCDA) is

defi ned as advertising directly to the consumer (or

patient) through print or electronic media These include

newspaper, magazine, billboard, television, radio, and

Internet advertisements [ 2 ] There are three categories

of DTCDA described by the FDA’s Division of Drug

Marketing, Advertising, and Communications: (1)

“help-seeking” advertisements, (2) “reminder”

adver-tisements, and (3) “product claim” advertisements—of

which only the latter two are regulated by the FDA

A “help-seeking” advertisement describes a disease

or condition, but does not discuss specifi c treatments

For example, an advertisement that states that there are

treatments for hair loss and encourages men to seek a

doctor’s advice for more information qualifi es as a

“help-seeking” advertisement A “reminder”

advertise-ment advertise-mentions a specifi c drug by name, but does not

mention its indications or effi cacy Reminder

advertise-ments assume that the audience already knows the

medication’s intended use The FDA does not require

these two types of advertisements to disclose risk information because the advertisements do not discuss benefi ts

The most common and most controversial DTCDA category and the major focus of this discussion, is the

“product claim” advertisement, which mentions both the name of the medication and its FDA-approved indications The FDA requires these advertisements to present balanced information about a medication’s risks and benefi ts [ 3 ] The requirement for lengthy side effect disclosures historically precluded television and radio product claim advertisements In 1997, the FDA loosened this requirement so that only the most impor-tant risk information needed to be mentioned, along with sources for accessing additional information These “sources” could include toll-free telephone numbers, references to a magazine print ad or website address, or a statement like “ask a health care profes-sional” [ 3 ] As a result, the U.S became one of only two countries (the other being New Zealand) to allow televised DTCDA [ 4 ] In the ensuing decade, spending

on broadcast DTCDA increased more than threefold [ 5] , while generating considerable debate regarding DTCDA effects on patient care and the patient-physician relationship

FDA guidelines stipulate that printed advertisements must disclose each side effect, warning, precaution and contraindication from the approved product professional labeling FDA-approved patient labeling that focuses on the most serious risks and less serious, but most fre-quently occurring, adverse reactions is also acceptable The latter must include: contraindications, warnings, major precautions (including any that describe serious adverse events), and the 3–5 most common non-serious adverse reactions likely to affect the patient’s quality of life or compliance with drug therapy

Critics of DTCDA believe the practice compromises public health in several ways First, it may threaten pub-lic health if it provides inaccurate, incomplete, or mis-leading information Consumers could seek improper and even dangerous treatments Additionally, there is the concern that, given its purpose to generate sales and profi t, such advertising is inherently biased and pro-motes inappropriate prescribing Even accurate and impartial advertising may also be harmful

Some fear that time spent discussing DTCDA during patient visits squanders already limited time for physi-cian-patient encounters [ 6 ] On the issue, the American College of Physicians states:

3 Direct-to-Consumer Advertising of Prescription Medications: Misguided “Autonomy” in the Information Age

[DTCDA] consumes valuable time during the

physician-patient encounter fi elding requests, clarifying

miscon-ceptions, and explaining other, sometimes more effective

treatments… Time spent on this gets diverted from

patient education to negotiation Then depending on the

patient’s insurance plan, negotiation on what is and is not

covered When a coveted drug is not part of a patient’s

health plan’s formulary, patients may pressure physicians

to make a case for medical necessity in hopes to get the

prescription covered—another round of hassle and effort

for the physicians And when a physician withholds

something a patient wants, patients often build mistrust

in the physician The result is a subtle but chronic

adver-sarial element in the doctor-patient relationship that takes

a substantial emotional toll on physicians [ 7 ]

It is unclear whether prescription requests prompted

by DTCDA are any more numerous or time consuming

than prescription requests prompted by other sources

(friends, family, or patient-support blogs)

Other critics worry about promoting the belief that

there is a “pill for every ill” [ 5 ] This belief may

obscure patients’ responsibilities to live a healthy

life-style Lastly, there is concern that DTCDA may

exac-erbate inequalities within the health care system

Studies reveal that physicians may be less willing to

honor requests for medications from patients who are

elderly, less educated, or racial minorities [ 8 ] These

arguments against DTCDA appeal to fundamental

principles of medical ethics Proponents of DTCDA

argue that it provides a public service by educating

patients Specifi cally, such advertisements remove

the stigma accompanying certain diseases (e.g

dep-ression, erectile dysfunction, hair loss); empower

patients to “take charge” of their health [ 9 ] ; and

encour-age patient-initiated dialogue with physicians which

increases the likelihood of appropriate care for

“fre-quently under-diagnosed and under-treated conditions”

[ 10] Collectively, these arguments support patient

autonomy Proponents further claim that DTCDA

“stimulate[s] competition, resulting in lower [drug]

prices” [ 9 ] and encourages compliance with

prescrip-tion drug treatment regimens, though no data is

pro-vided to support either claim [ 9 ]

Central to this debate is the inherent confl ict

between the fi duciary responsibility of a manufacturer

to its shareholders and the industry’s stated mission to

better public health [ 6 ] These confl icting goals become

especially relevant when DTCDA provides

informa-tion regarding a medicainforma-tion’s risks In one report, a

panel of pharmacists judged that only 65% of DTCDA

presented a fair and balanced discussion of risks and

benefi ts [ 11 ] Another report found that 91% of pled televised advertisements recited risks nearly 50% faster than benefi ts [ 12 ]

sam-In addition to highlighting the inherently biased nature of DTCDA, studies have begun to examine its public health impact Current data support the claim that DTCDA increases consumer awareness and fos-ters patient-initiated communication with physicians For example, the common catch phrase, “Ask your doctor about Drug X,” heard in DTCDA, may enhance communication between patients and physicians Some argue, however, that it may imply to patients that their doctors cannot be trusted to provide necessary information without prompting [ 13 ] For this reason, the American Medical Association (AMA) has advo-cated that the phrase “your physician may recommend other appropriate treatments” be incorporated in direct-to-consumer advertisements

In addition, many patients do not recognize the potential for bias in drug advertisements The belief that DTCDA provides enough information to decide (without physician input) if a medications benefi ts out-weigh its risks is inversely correlated with education level [ 14 ]

As with other forms of pharmaceutical advertising, DTCDA has been shown to affect physicians’ pre-scribing practices A multi-site, randomized-controlled trial evaluated blinded physicians’ responses to three groups of standardized patients with major depression symptoms [ 15 ] One group requested a highly adver-tised costly formulary medication (Paxil™); a second requested a prescription without specifying the medi-cation, while the third group did not request a prescrip-tion at all Results showed that patients who did not request prescriptions were much less likely to receive treatment compared with those who did (31% vs 75%), and were signifi cantly less likely to have a diag-nosis of depression recorded in their medical charts (65% vs 88%) Of those requesting the advertised drug by name, 27% received the drug (compared to 3% requesting an unspecifi ed prescription drug), while 26% received a less expensive alternative, and 47% received no prescription at all

Thus, symptomatic patients who asked for any depressant were much more likely to receive adequate depression diagnosis and care than those that did not request a prescription This study suggests that DTCDA-prompted prescription requests may lead to improved diagnosis and treatment The study also revealed that

anti-16 L Pappas-Taffer and A Miller

advertisement-specifi c prescription requests do increase

the prescription volume for a particular drug, even

when there may be potentially less expensive

therapeu-tically equivalent options available

Analysis of Case Scenarios

In Case 1 , a young woman presents with chronic,

severe psoriasis for the fi rst time She has failed

meth-otrexate and her hectic work schedule precludes

pho-totherapy She reports a signifi cantly reduced quality

of life, feelings of stigmatization, and lack of trust in

her previous dermatologist Did the advertisement for

the injectable biologic drug enhance her autonomy?

Autonomy refers to the right of competent informed

individuals to make their own healthcare decisions

without coercion or interference from others Freedom

from coercion, however, does not imply that the patient

has all of the tools necessary to make an informed

deci-sion on his or her own Advertisers motivate consumers

to buy their products using many tactics, including

appeals to emotions As a result, direct-to-consumer

advertisements can exploit the vulnerabilities of

derma-tologic patients with disfi guring or unsightly diseases

Although the advertisement in Case 1 verbally relayed

accurate information—the non-verbal message was

misleading The joyful story line belied the potentially

serious and even lethal side effects of the advertised

medication Specifi cally, the non-verbal message

down-played the risks while subtly suggesting a benefi t

unre-lated to the effects of the drug itself, namely social

intimacy The advertisement failed to mention

qualify-ing criteria for the medication, cost, or alternative

ther-apies Thus, the advertisement in Case 1 prompted

enhanced awareness, but not necessarily autonomy

True autonomy requires balanced and suffi cient

information

Case 2 involves a magazine advertisement for a

medication in which the information provided to the

patient is misleading and inaccurate The

advertise-ment states that it is “all natural,” suggesting that it

would therefore be less toxic than other wart

medica-tions This is enticing to the patient because she states

she would like to become pregnant soon However, it

would be important to note that the medication has not

necessarily been evaluated in pregnant women, and

that “all natural” doesn’t make it superior or less toxic

(or teratogenic) than other genital wart therapies

There are at least two inaccuracies in this ment First, its comparative claim that this is the fi rst natural wart product is incorrect (liquid nitrogen and podophyllin are also “natural”), as well as being in violation of AMA guidelines that prohibit claims of this type Second, the statement that this medication

advertise-“utilizes the therapeutic power of nature to rid genital warts for good” suggests that it will cure genital warts forever, which no genital wart treatment can claim Such informational inaccuracies could not only result in unrealistic expectations, but also signifi cant unintended negative consequences For example, recur-rence of genital warts in this patient following treat-ment could be misinterpreted by the patient as a new infection due to the infi delity of a longstanding partner Therefore, it is important that physicians pay attention

to DTCDA in order to prevent unrealistic expectations and misinterpretations As in Case 1, inaccurate or biased information may be detrimental to informed patient decision-making It is essential that the treating physician address these inaccuracies

Case 3 demonstrates an advertisement for a topical

drug to prevent hair growth Although one of the cited benefi ts of DTCDA is removing a condition’s stigma, it may actually do just the opposite This adver-tisement achieves two related goals: it stigmatizes hypertrichosis, stressing its personal and social unde-sirability, and it provides a potential solution This advertisement does not provide a public service by raising awareness of a “hidden” problem, it creates one This phenomenon is called “medicalization.” This

often-is a term that refers to the process by which a logic condition or behavior is labeled as a medical problem or illness for which the medical profession has treatment [ 16 ] This process can be driven by new evidence or theories about conditions, by develop-ments in social attitudes, by economic considerations,

physio-or by the development of potential therapy [ 16 ]

Conclusion

Direct-to-consumer drug advertising has become asingly prevalent in the U.S The concept of DTCDA is not inherently unethical In fact, many of the criticisms leveled against DTCDA could also be applied to adv ertising directed toward prescribers To the extent that DTCDA enhances patient awareness and encour-ages patient-initiated communication with physicians, it

3 Direct-to-Consumer Advertising of Prescription Medications: Misguided “Autonomy” in the Information Age

promotes patient autonomy and appropriate care

How-ever, pharmaceutical advertising, including DTCDA

should not be viewed as educational material If the

intent were to educate, then the nature of

advertise-ments would be strictly informational—not eye-catching

seductive, or disingenuous The goal of any

advertise-ment is to engage and motivate patients to buy the

prod-uct, and should be viewed as such In most cases, such

advertising falls short of fully informing patients It

remains the role of the physician to educate the patient

regarding appropriate choice of medications

References

1 Findlay S Prescription drugs and mass media advertising

Washington, DC: National Institute of Health Care

Management Research; 2000 http://www.nihcm.org/pdf/

DTCbrief.pdf Accessed 5 Nov 2011

2 Direct-to-consumer advertising in the United States Source

Watch 2008 http://www.sourcewatch.org/index.php?title=

Direct-to-consumer_advertising_in_the_United_States

Accessed 5 Nov 2011

3 Food and Drug Administration Keeping watch over

direct-to-consumer ads http://www.fda.gov/ForConsumers/Consumer

Updates/ucm107170.htm Posted 10 May 2010 Accessed 5

Nov 2011

4 Toop L, Mangin D The impact of advertising prescription

medicines directly to consumers in New Zealand: lessons

for Australia Aust Prescriber 2006;29:30–2

5 Connors AL Big bad pharma: an ethical analysis of

physi-cian-directed and consumer-directed marketing tactics

Albany Law Rev 2009;73:243–82

6 Robinson AR, Hohmann KB, Rifkin JI, Topp D, Gilroy CM,

Pickard JA, et al Direct-to-consumer pharmaceutical

adver-tising: physician and public opinion and potential effects on

the physician-patient relationship Arch Intern Med 2004;

9 Lyles A Direct marketing of pharmaceuticals to consumers Annu Rev Public Health 2002;23:73–91

10 PhRMA guiding principles: direct to consumer ments about prescription medicines http://www.phrma.org/ sites/default/files/631/phrmaguidingprinciplesdec08final pdf Posted Dec 2008 Accessed 5 Nov 2011

11 Roth M Patterns in direct-to-consumer prescription drug print advertising and their policy implications J Public Policy Mark 1996;15:63–75

12 Kaphingst KA, DeJong W, Rudd RE, Daltroy LH A content analysis of direct-to-consumer television prescription drug advertisements J Health Commun 2004;9:515–28

13 Jagsi R Confl icts of interest and the physician-patient tionship in the era of direct-to-patient advertising J Clin Oncol 2007;25:902–5

14 Consumer reaction to DTC advertising of prescription cines Seventh annual survey Prevention Magazine; 2003–

medi-2004 Cited in: http://docs.google.com/viewer?a=v&q=cache: 7SfW2PauLksJ:www.fda.gov/ohrms/dockets/ac/08/ slides/2008-4362s1-03.ppt+Consumer+reaction+to+DTC+a dvertising+of+prescription+medicines.+Seventh+annual+su rvey.+Prevention+Magazine%3B&hl=en&gl=us&pid=bl&s rcid=ADGEESgaDEXO6NjffbTLvy3Cvke13DFVWRVbR-

B y 4 e b c K Q j c u d 2 i P r z s v S 7 m 7 W m N Q B _ 6 9 4 U 4405Rv3TskDbwyQi8XPU3JVZV-ZfffvV8EBIUpGQ kZj0yML2eD29_bl_mrN2rpOoRuzeZ&sig=AHIEtbS3rqj_ CzTPD56UP9yVwguglunvIw Accessed 5 Nov 2011

15 Kravitz RL, Epstein RM, Feldman MD, Franz CE, Azari R, Wilkes MS, et al Infl uence of patients’ requests for direct- to-consumer advertised antidepressants: a randomized con- trolled trial JAMA 2005;293:1995–2002

16 Conrad P Medicalization and social control Annu Rev Sociol 1992;18:20

L Bercovitch and C Perlis (eds.), Dermatoethics,

DOI 10.1007/978-1-4471-2191-6_4, © Springer-Verlag London Limited 2012

4

Autonomy, Isotretinoin and iPLEDGE: The Ethics of Burdensome Regulation and Use of Teratogenic Medication

Kenneth E Bloom and Lionel Bercovitch

Case 1

A 21-year-old woman presents to the university

stu-dent health service dermatology clinic requesting

isot-retinoin for chronic scarring nodular acne Despite

reasonable trials of alternative therapies, her acne

remains active She states that she is not sexually active

and wishes to choose abstinence as her method of

con-traception During further discussion she confi des that

she is a lesbian and not sexually active with males Her

medical record shows she received emergency

contra-ception treatment at the university health clinic within

the past 6 months The patient explains that she only

vaguely remembers being drunk at a campus party and

has no recollection of the events following

Case 2

A 20-year-old woman with scarring nodular acne

refractory to several months of topical and systemic

therapies presents to discuss alternative treatments

She is anxious to start isotretinoin after learning

about its potential to clear her acne She is willing to

participate in the pregnancy protection measures of

the iPLEDGE program Based on her religious beliefs, however, she opposes abortion and emergency contraception

Case 3

A 16-year-old girl has been referred by her pediatrician

to discuss the possibility of instituting treatment with isotretinoin The patient is desperate to start isotretinoin because her acne is socially embarrassing to her and she

is willing to comply with whatever the dermatologist recommends She is felt to be a good candidate for treat-ment, but her mother, who is present in the room, refuses

to allow her daughter to use hormonal contraception or

to consider termination of pregnancy in the event of an unplanned pregnancy Furthermore, the mother states that her daughter is not and has never been sexually active She also refuses to allow the dermatologist to interview her daughter privately regarding these issues (even with a same sex chaperone present in the room)

Case 4

A 19-year-old woman presents to the dermatologist to discuss isotretinoin after failing aggressive topical and systemic therapies for severe acne The dermatologist feels that she is a good candidate for isotretinoin The dermatologist, however, is opposed to emergency con-traception and abortion on moral and religious grounds

He therefore does not feel comfortable prescribing the medication for women of childbearing potential, but is comfortable prescribing the medication to women incapable of conceiving as well as men

K.E Bloom

Dermatology Center for Children and Young Adults, PA ,

Eagan , MN , USA

Department of Dermatology , University of Minnesota Medical

School , Minneapolis , MN , USA

L Bercovitch ( * )

Department of Dermatology , Warren Alpert Medical School

of Brown University , Providence , RI , USA

e-mail: lionel_bercovitch@brown.edu

20 K.E Bloom and L Bercovitch

Discussion

Introduced in the US in 1982, isotretinoin is a highly

effective treatment for nodulocystic acne A single

3–4 month course of isotretinoin 1–2 mg/kg/day can

clear 60–95% of infl ammatory lesions in patients with

recalcitrant nodulocystic acne [ 1 ] Unfortunately,

how-ever, the medication is also associated with several

signifi cant adverse effects including teratogenicity

Isotretinoin exposure during embryogenesis is

associ-ated with a risk of major birth malformations estimassoci-ated

to be up to 30% [ 2 ] The United States Food and Drug

Administration (FDA) has classifi ed isotretinoin as

pregnancy category X, meaning that its teratogenicity

outweighs its benefi ts to the pregnant patient

From the time the medication was released, the

package insert contained warnings of possible

congeni-tal malformations resulting from in utero exposure to

isotretinoin (“isotretinoin embryopathy”) As a result

of pregnancies occurring despite these warnings and

patient education, three increasingly restrictive and

burdensome risk management programs were

intro-duced, each with the stated goal of eradicating fetal

exposure to this teratogen by either preventing women

who were already pregnant from receiving isotretinoin

or by ensuring that no women became pregnant while

the medication was in their systems These included the

Roche Pregnancy Prevention Program (PPP) (1998–

2001), the Roche SMART (System to Manage Accutane

Related Teratogenicity) program (2001–2005), and

iPLEDGE (2005-present)

Although each of the three risk management

pro-grams had the stated goal of eliminating in utero

expo-sure to isotretinoin, it has become clear that while

desirable, this goal is probably unattainable Despite

stringent regulations, there are continued reports of

isotretinoin exposure to developing embryos in the

US One early study reported 900 pregnancies over a

10-year-period among the approximately 38–40% of

reproductive-aged women who chose to enroll in the

Boston University Accutane Survey [ 3 ]

The current program, iPLEDGE was introduced in

2005 in order to harmonize each manufacturer’s

preg-nancy risk management program There were also

con-cerns that the FDA would revoke approval of isotretinoin

if in utero exposure were not reduced The iPLEDGE

program imposed such stringent and burdensome

requirements on prescribers, patients, and pharmacies

that it was initially not well received It requires women

of childbearing potential to undergo thorough ing about the teratogenic risks of isotretinoin, registra-tion in a national database, and multiple (and ongoing) negative pregnancy tests (Table 4.1 )

Despite the desirable goal of reducing embryonic exposure to isotretinoin, the methods adopted have raised several ethical concerns and criticisms Restrict-ions on patient autonomy, unequally applied regula-tions, confi dentiality concerns, and the physician’s right of conscience are four of the ethical issues raised

by isotretinoin risk management programs

iPLEDGE intentionally restricts patient reproductive autonomy Women of childbearing potential must agree

to practice abstinence or at least two forms of tion if they could be sexually active Additionally, patients must have two negative pregnancy tests prior to starting isotretinoin and undergo monthly pregnancy tests while receiving the medication Imposing restric-tions on a patient’s reproductive decisions, however, can

contracep-be viewed as inappropriate interference with the patient’s autonomy Doshi commented that isotretinoin manufac-turers and the FDA are obligated to ensure women receive suffi cient information to make informed repro-ductive decisions, but that mandating certain reproduc-tive behavior may be diffi cult to justify [ 4 ]

On the other hand, regulatory agencies have a mate interest in preventing serious congenital malfor-mations Restricting autonomy to prevent harm to third parties, in this case, the developing embryo, is a compel-ling argument [ 5] Just as some states mandate that motorcycle riders wear helmets and children wear car seats, iPLEDGE may be justifi ed to reduce the societal burdens of birth defects While the decision to use the medication should be between the physician and patient,

legiti-a RMP such legiti-as iPLEDGE legiti-allows it to be used under conditions that minimize the risk of embryonic expo-sure to the drug Imposing such a program, even though

it disproportionately burdens women of child-bearing age with its requirements, allows the medication to remain available to all who need it, while minimizing adverse reproductive outcomes resulting from inadver-tent in utero exposure Although not a perfect and equi-table solution, it provides the greatest societal benefi t

A second ethical concern is that the iPLEDGE gram unfairly limits access to isotretinoin in several ways These regulations are unjust in that they impose signifi cantly more restrictions on women of childbear-ing potential than other patients Additionally, iPLEDGE requirements for literacy (to understand and follow the

4 Autonomy, Isotretinoin and iPLEDGE: The Ethics of Burdensome Regulation and Use of Teratogenic Medication

program), practicing two forms of contraception, and

access to a registered iPLEDGE prescriber may unjustly

block poor, uneducated, and geographically remote

individuals from benefi ting from isotretinoin [ 6, 7 ]

Justice—as it relates to isotretinoin access—is an

important ethical consideration Fair and equal access

is a reasonable goal Different regulations for different

populations are, however, justifi ed when the regulatory

variation depends on the population characteristics

For example, there is no reason to test men or

post-menopausal women for pregnancy when they are

physically incapable of becoming pregnant Since the

goal of iPLEDGE is to eliminate in utero exposure to

isotretinoin, only those capable of becoming pregnant

reasonably require such testing

Unequal access to the medication based on

socio-economic or geographic considerations is troubling,

but not unique Access to high quality health care in

the US varies based on education, location, and

socio-economic status In this way, potential inequalities

associated with isotretinoin access simply refl ect the

same problems found with all other medications in

the US

Another ethical concern is that isotretinoin is

unfairly regulated relative to other teratogenic

medica-tions or even behaviors It is reasonable to regulate

isotretinoin since in utero exposure to the drug

repre-sents a signifi cant problem and measures can

reason-ably be taken to reduce the likelihood of such exposure

In addition, use of thalidomide, a drug used in the

treatment of Hansen’s disease, multiple myeloma, and

certain collagen vascular diseases has long been lated in women of childbearing potential by a program upon which iPLEDGE was modeled However, expo-sure to acitretin, another category-X retinoid, during pregnancy may not be as great a concern because the number of exposures is so small relative to those to isotretinoin and no program exists to regulate in utero exposure to this medication Regula ting access to alco-hol and other teratogens by women of child-bearing potential may simply be impractical [ 7 ]

regu-A third set of ethical concerns raised by the iPLEDGE program involves confi dentiality Recalci-trant nodulocystic acne frequently affects minors Isotretinoin use by a minor requires parental consent Discussions of sexual activity are invariably of a per-sonal and sensitive nature A candid conversation about sexual activity may be diffi cult to achieve with a parent present Determining the right balance between paren-tal participation, and consent, and an honest, confi den-tial physician-patient relationship may be ethically challenging

The whole question of contraception for minor patients on isotretinoin is not some hypothetical con-cept The most recent published data from the Centers for Disease Control (CDC)’s Youth Risk Behavior Surveillance System showed that 46% of high school students (as high as 72% in some sub-groups) had ever had sexual intercourse and that 6% of students had their fi rst sexual intercourse before age 13 years [ 8 ] Nationally, 53% of female high school seniors were sexually active at the time of the surveys

Table 4.1 The essential components of the iPLEDGE program [ 13 ]

• All patients who are to receive isotretinoin must be registered with the iPLEDGE system and receive a unique identifi er

number

• Physicians and pharmacists must register with iPLEDGE in order to respectively prescribe or dispense isotretinoin

• A provider can delegate other prescribers to prescribe isotretinoin to patients already registered in that provider’s name and can delegate offi ce staff to do the requisite data entry necessary to activate a prescription

• Each patient must sign a consent form (or in the case of females of childbearing age, multiple consent forms) in order to receive isotretinoin

• Patients must be seen by the prescriber monthly and counseled at each visit not to donate blood while on isotretinoin and not

to share their medication Females of childbearing age must also complete a monthly online or telephone assessment of their understanding of the risks of pregnancy and to confi rm to the provider that they are using two forms of contraception

acceptable to the iPLEDGE program

• Females of childbearing potential have a 30 day period after registration in which they must be using their two chosen forms of contraception before they can actually start isotretinoin They must have two negative pregnancy tests prior to starting

isotretinoin

• Females of childbearing potential have a 7 day window after the required monthly pregnancy test in which to fi ll their

prescriptions By contrast, men and women who are unable to get pregnant have a 30 day window

• Contraception must be continued for a month following the last dose and a follow-up pregnancy test must be reported to iPLEDGE