Transcript Slide 1

Physician/Pharmaceutical
Relationships
Are there Ethical Boundaries ?
Katie Grimm, MD
Women& Children’s Hospital
Adolescent Division
[email protected]
Objectives:
 A view from the past: The Medical Ethic
 The view from Organized Medicine
 Ethical Underpinnings
 Today’s viewpoint
 Is there a resolution?
Original Code of Medical Ethics
National Medical Convention of the AMA,1847
 “Medical ethics, as a branch of general ethics, must
rest on the basis of religion and morality”
 “Veracity, so requisite in all the relations of life, is a
jewel of inestimable value in medical description and
narrative, the lustre of which ought never to be
tainted for a moment, by even the breath of suspicion”
 “We are under the strongest ethical obligations to preserve
the character which has been awarded, by the most
learned men and best judges of human nature, to the
members of the medical profession…” (Code, 1847)
 CEJA Report 2001: “building on the Hippocratic tradition,
physicians were called upon to hold a sense of ethical
obligation that rose above considerations of personal
advancement”
 The AMA : the medical profession’s “prime objective”
is to render service to humanity (Beauchamp
&Childress)
 Physicians urged to be “upright” and “pure in character
and ….diligent and conscientious in caring for the
sick.”
 Virtues have been de-emphasized since the 1847 Code
of Ethics
 Does emphasis on virtues change depending on the
practice patterns at the time?
Bringing focus to the problem
 Early characterization by the AMA calling the early
pharmaceutical companies the “ethical”
drug companies, to distinguish them from
unscrupulous patent-medicine peddlers.
 The concern is now the embedding of these companies
within the relationship between the physician and the
patient
Far too large a section of the treatment of
disease is today controlled by the big
manufacturing pharmacists, who have
enslaved us in a plausible pseudo-science. The
remedy is obvious-give our students a firsthand acquaintance with disease and give them
a thorough practical knowledge of the great
drugs and we will send out independent,clearheaded,cautious practitioners who will do their
own thinking…….
Sir William Osler, 1909 Can Lancet
Is there an ethical basis for
decision making?
 There is not one ethical theory, nor moral solution to
provide a single solution but there are foundations
based in ethical philosophy
 Principles and rules are not always the determinant of
moral character, but rather it is the agent who
performs these actions that is important
 Rules do not determine compassion, patience and
patient responsiveness (Beauchamp and Childress)
 “Virtues” are the determinant of the value of a
relationship
Principles
Autonomy
Beneficence
Non-Maleficence
Justice
Autonomy
 Liberty: Freedom to influence choices and
decisions
 The primary responsibility of the physician is to
serve the patient’s interest
 Truth telling by the physician is an integral part
of understanding autonomy
Beneficence
 To do “good”
 Conflict of interest :must not
participate in activities that are not in a
patient’s best interest
Non-Malficence
To do no harm, to avoid harm, and
to prevent harm
Justice
 Distributive Justice
fairness, what is deserved, entitlement
 Broadly refers to “rights and
responsibilities”
 Character more important than rules, and virtuous
character can be cultivated over time through role
models, educational interactions
 An Aristotelian framework that understands that
virtuous behavior can be a skill that is learned,
cultivated, and rewarded
 Professional roles incorporate virtues as a basis for
action
 Professional virtues are historically ingrained and
integrated in medicine
Five Focal Virtues
 Compassion : active regard for another person’s
welfare
 Discernment : “sensitive insight, acute judgment, and
understanding..” (how principles and rules are applied
in given contexts)
 Trustworthiness : “ a confidence that another will act
with the right motives and in accordance with
appropriate social norms”
 Integrity : fidelity
 Conscientiousness : due diligence
 “Science cannot stop while ethics catches up”
 Howard Brody, a medical ethicist, has characterized
this as “moral compromise”
 What may have started as a casual alliance has now
such complexity and “invisible” bonds that is often
difficult to discern the level of embedding
 “A Profession is not just a way of making money; it’s a
form of public trust…”
What is happening today?
 December, 2007 : White Paper authored by the
Corporate Governance Task Force of the American
Health Lawyers Association Vendor-Healthcare
Professional Gift Giving, Marketing, and Compliance
 “ approximately 90% of the $21 billion marketing
budget of the pharmaceutical industry is directed at
physicians…”
 “rising health care costs have increased scrutiny of
these interactions”
What about today?
 January 25, 2006: JAMA “ Health Industry Practices
that create Conflicts of Interest”
 “ Physicians’ commitment to altruism….now regularly
come up against financial conflicts of interest”
 From The Lancet:“ Do those doctors who support
this culture for the best of intentions…have the
courage to oppose practices that bring the whole of
medicine into disrepute?”
MD vs. MDeity
 How to separate legitimate vs. non-legitimate
endeavors?
 Minnesota data: Doctors and medical organizations
received more than $42 million from the
pharmaceutical industry from 2002-2005
 There are variations in these relationships that vary
according to state, specialty, and professional activity
 No “broad-brush” approach
 From the Lancet, April 6,2002: “spending on
prescription drugs in the USA soar(ed) by a
remarkable 17% in 2001…retail spending on
prescription drugs was $155 billion in 2001, almost
double what it was in 1997”
 “How tainted by commercial conflicts has medicine
become?”
JAMA, 2006
 “Conflicts of interest occur when physicians
have motives or are in situations for which
reasonable observers could conclude that
the moral requirements of the physician’s
roles are or will be compromised.”
 “ Grants or support for educational activities that are
sponsored and organized by medical professional
organizations raise little risk of fraud”
 An “explosion” of change in the area of enforcement of
policy and procedures that have been written
describing professional relationships with vendors and
drug companies
Is the Virtuous Physician model
Attainable?
 Is the highly complex world of medicine an
environment that is impossible to carry out the
professional commitment?
 Codes of Ethics that attempt to clarify the mores of
action
 Caution with oversimplification,i.e. pursuit of
professional norms to protect the professions’ interest
 Need for persistent improvement and education
 Public supervision and scrutiny
 Increasing scrutiny requires vigilance to maintain the
ethic that has defined the fiduciary relationship that is
the tradition in medicine
 Self-regulation to reduce the need for external
regulation and legislation
 AMA tasks for an organized medical staff :“ develop
disclosure and conflict of interest policies for
physicians in leadership”
 Ethics Education
 The Oslerian view
 Physician disclosure and preserving the fiduciary
relationship
 Dialogue on the issues
 An evolving role for the bioethicist?
 The global view
 “Ethics permeates all that we do in medicine” : beliefs
which guide our actions
Thank you !!