Ethics and Professionalism:The Integrity of Medicine

Richard L. Elliott, MD, PhD, FAPAProfessor and Director

Medical Ethics and ProfessionalismMercer University School of Medicine

Adjunct ProfessorMercer University School of Law

Goals Week one

– Review first year ethics– Research and ethics

• “The purpose of Community Medicine II is to introduce the concept of evidence-based medicine”

• Tuskegee, IRBs– Small group discussions (exam material!)

Week two Research ethics II: Conflicts of interest Medical student abuse and impaired colleagues Medical malpractice Exam (14 multiple choice questions)

ObjectivesAt the end of the phase you should be able to:

Distinguish aspects of the TSUS which were ethical and unethical

Discuss the ethics of duplicate publication, ghost writing, disclosure of potential conflicts of interest and the nature of publication bias

Discuss the role of patient assent and parental informed consent in the enrollment of minors in clinical research trials

Discuss ethical issues in the enrollment of patients in double-blind, placebo-controlled clinical trials

Objectives

Discuss ethical aspects of enrolling subjects in phase 1, 2, and phase 3 clinical trials

Describe vulnerable populations in clinical trials

Describe the 4 Ds of medical malpractice Describe the role and ethical duties of an

expert witness in a medical malpractice case Discuss the appropriate response after an

adverse medical incident

Objectives Describe the primary reasons why patients

sue after an adverse medical incident Describe factors associated with awarding

of damages in malpractice suits Discuss appropriate documentation after a

medical error Describe the relationship between medical

injuries and malpractice claims

Resources http://medicine.mercer.edu/

– Go to “Programs”– Go to “Ethics and Professionalism”– Cases under “Preparation”– PowerPoints may be loaded on Blackboard

Review

What are the four principles of medical ethics?

Autonomy Beneficence Nonmaleficence (primum non nocere) Social justice What is Rule #1? First, be a good doctor

USMLE #1

1. A 72-year-old man with prostate cancer had surgery and felt well for two years before bone metastases were discovered. He begins to suffer pain and nausea. He is clear-minded and fully understands his medical condition, prognosis, and treatment options. The patient consistently tells you orally and in writing that he does not want further treatment and wants his physicians to focus on pain relief. With the patient’s agreement, a DNR order is in place. In the hospital, the patient loses consciousness, and his family requests that the DNR be reversed.

You should:

Agree with the family and change his DNR status Tell the family you cannot change his DNR status Ask for an Ethics Committee consultation Attempt to build a relationship with the family, to

educate them, and to help them accept the patient’s decision and their grief

MR and Leukemia Ms. Smith is a 39-year-old woman with

severe mental retardation. Her parents have died and no information is available about other living relatives. She lives at a long-term care facility and a court-appointed guardian has been appointed to make health care decisions for her. She has never been able to express preferences of her own concerning these decisions. She has developed leukemia. Treatment involves significant risk and discomfort and only a small chance of prolonging her survival.

On what basis should you proceed?

Substituted judgment? Best interests?

What should be done about her treatment?

Proceed with the chemotherapy Withhold chemotherapy Confer an “expert panel” to determine therapy Discuss options and likely outcomes with the

guardian and ask the guardian what is in the best interests of the patient

Ethics in Research

Richard L. Elliott, MD, PhDProfessor and Director

Medical Ethics and Professionalism

Mercer University School of Medicine

Adjunct Professor

Mercer University School of Law

Is Clinical Research Ethics Relevant to Me?

Are you going to conduct or participate in medical experimentation?

Many physicians participate in formal research

Most physicians will use the results of clinical research

All physicians will have contact with research derived from the pharmaceutical or medical device industries

Common Areas of Concern How “informed” is informed consent in research?

– Clinical risks and benefits, use of results for profit Research in vulnerable populations

– Poor, children, poorly educated, mentally ill/MR Research in special settings

– Intensive care units, emergency rooms, prisons Funding and conflicts of interest

– Publication bias, stifling negative results Publication issues

– Authorship, plagiarism, fraud Animal rights Use of placebos

Goals

Describe common research situations posing ethical issues– Historical– Current

Describe application of ethical reasoning to research List important resources for ethics in research Describe ethical issues in our relationships with the

pharmaceutical industry Analyze cases involving clinical research

Background to TSUS

Jenner vaccinated boy, exposed him to smallpox 1840s J. Marion Sims - surgical experiments on

enslaved women and infants without anesthesia 1874 MD opened skull of woman with tumor and

stimulated cortex with electricity until she died 1896 LPs done on children at Children’s Hospital in

Boston without parental consent to see if LP harmful 1900 US Army infected prisoners with bubonic plague Many other examples of deliberate infections with

syphilis, tuberculosis, cholera, . . . Informed consent not well developed until 1960s

Yellow fever

Walter Reed, MD 1851-1902 Jesse Lazear, MD PhD 1866-1900

“To know syphilis is to know medicine”Sir William Osler 1849-1919

Early Treatments for Syphilis

Julius Wagner-Jauregg, MD 1857-1940 Paul Ehrlich, MD 1854-1915

Syphilis - 1930 Widespread (leading cause of mental illness) Treatment dangerous

– Mercury, arsenicals, bismuth, malaria

But a previous study of course of syphilis in whites showed treatment preferable to no treatment

Some thought a study was needed to compare outcomes in treated vs. untreated syphilis in blacks

Tuskegee Study of Untreated Syphilis

1932-1972 US PHS 600 subjects

– 399 with syphilis, 201 controls To determine course of untreated

syphilis in African American men Julius Rosenwald Fund

Eunice Rivers

Treatment!

Penicillin and Syphilis Penicillin available 1943 Treatment of venereal diseases mandatory in

Alabama and draft boards required treatment Subjects received notices from draft boards

ordering treatment Orders given to withhold treatment 1946-48 – U.S. infected prisoners, prostitutes

and mental patients with syphilis to test effectiveness of penicillin. 83 subjects died

Nuremberg Code (1947) Voluntary consent of competent individual Benefits society, not obtainable by other means Sufficient scientific basis to justify experiment Avoids unnecessary suffering and injury Avoid disabling injury or death unless MDs are

subjects Degree of risk proportional to societal benefit Facilities and preparations to protect subjects Conducted by qualified investigators Subject can terminate participation Investigator should terminate if unsafe to participant

World Medical Association Declaration of Helsinki

1964, most recently clarified 2004 Some research populations are vulnerable and need

special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care.

Questions use of placebos

Tuskegee Study1968 Peter Buxtun voices

concerns

1969 CDC, AMA, NMA reaffirm support for TSUS

1972 Buxtun approaches AP, expose published

1973 HEW Report critical of Study

Ethical Problems with TSUS Failure to inform subjects of nature of study

and their illness Deception around “treatment” (LP, placebo) Failure to offer treatment when Rosenwald

Fund became solvernt Failure to inform subjects of penicillin Failure to offer penicillin Failure to inform partners of risks Was failure to offer Rx at outset unethical?

Retrospective Ethical Assessments

Some things are always right– Categorical imperative

Some things are always wrong– Deceiving patients for TSUS purposes

Some things are right or wrong only in a culturally relative sense– Informed consent

• AMA 1847 unethical telling patients bad news

Was Tuskegee An Isolated Incident? 1946-48 Guatemala syphilis study 1956-70 Hepatitis and Willowbrook State School 1961 Milgram Yale study 1963 Cancer and Jewish Hospital for Chronic Diseases 1960-72 Cincinnati radiation exposure experiments 1971 Zimbardo Stanford prisoner experiments 1993-95 Johns Hopkins lead study 2011 Las Vegas MD indicted for infusing stem cells

Aftermath of Tuskegee

Widespread distrust among blacks of clinical studies

National Research Act of 1974 Belmont Report Institutional Review Boards

Belmont Report - 1979

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

(1) respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent;

(2) beneficence: maximizing benefits for the research project while minimizing risks to the research subjects; and

(3) justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly (the fair distribution of costs and benefits.)

Examples of Application of Ethical Principles to Research

Autonomy– Inform subjects of purpose of study, risks, benefits, alternatives,

right to withdraw– Consent from competent, voluntary subjects - consider vulnerability

Beneficence– Value to patient should outweigh risks– Stop trial if arms no longer equally beneficial (clinical equipoise)

Non-maleficence– Protect confidentiality

Social justice– Access to benefits from research– Ensure compensation not so great as to expose poor to excess risk

IRB National Research Act of 1974 (Title 45 CFR Part 46) Risks to research subjects are minimized and are

reasonable in relation to anticipated benefits Welfare and human rights of subjects are protected

and informed consent is sought from each prospective subject or the subject’s

Provisions for monitoring data collection are in place to assure the safety, and physical, emotional, and mental well-being of research subjects

Confidentiality of data/privacy of subjects are assured Researchers are qualified to conduct the research

Composition of IRB

At least 5 members, including one scientist, one non-scientist, one community member.

Members must not have conflict of interest If study involves vulnerable population, must

have member familiar with this group– Children, pregnant women, fetuses,

neonates, prisoners, mentally disabled, students, minorities, poor, terminally ill, AIDS/HIV (Mercer website – ethics - research)

Vulnerable Subjects

§46.107 IRB membership: “a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons”

§46.111 Criteria for IRB approval of research: “vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons”

Bottom line – if you think subjects are subject to undue influence or are decisionally handicapped, take precautions in review and implementation of research protocol

Exempt Studies Use of educational materials in

educational settings– Subjects cannot be identified

Review of existing data– Subjects cannot be identified

Evaluation of public service programs Should still submit to IRB to determine

study is exempt

Clinical Equipoise Ethical principle in controlled trials The must be genuine doubt within a community of

experts whether the treatment is beneficial Once the certainty of benefits (or adverse effects) is

established, the preferred treatment must be offered Problem: stacking the deck in favor of a sponsored

product – e.g., inadequate dosing of comparator So, if clinical equipoise is followed, we should reduce

trials unfairly designed to favor a particular treatment

If you participate in a research project

What are you being asked to do?– Is it something for which are qualified or will

receive training? Have you discussed use of results?

– Publication/poster– Authorship

Funding or other potential conflicts of interest? Is consent (if required) meaningful? Have you reviewed other ethical issues?

Research Case Analysis

Medicine.mercer.edu->second year->preparation Medical background: prognosis, alternative

treatment, risks of non-research treatment Purpose of study, risks/benefits, conflicts of

interest, nature of informed consent (competence, assent, voluntariness, quality of information), vulnerable population

What are the ethical issues? Relevant documents and reports What do propose as a solution?