Physician/Pharmaceutical Relationships

1. Physician/Pharmaceutical Relationships Are there Ethical Boundaries ? Katie Grimm, MD Women& Children’s Hospital Adolescent Division kategrimmmd@aol.com

2. Objectives: • A view from the past: The Medical Ethic • The view from Organized Medicine • Ethical Underpinnings • Today’s viewpoint • Is there a resolution?

3. Original Code of Medical EthicsNational 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”

4. “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”

5. 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?

6. 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

7. 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 first-hand acquaintance with disease and give them a thorough practical knowledge of the great drugs and we will send out independent,clear-headed,cautious practitioners who will do their own thinking……. Sir William Osler, 1909 Can Lancet

8. 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

9. Principles • Autonomy • Beneficence • Non-Maleficence • Justice

10. 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

11. Beneficence • To do “good” • Conflict of interest :must not participate in activities that are not in a patient’s best interest

12. Non-Malficence • To do no harm, to avoid harm, and to prevent harm

13. Justice • Distributive Justice fairness, what is deserved, entitlement • Broadly refers to “rights and responsibilities”

14. 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

15. 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

16. “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…”

17. 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”

18. 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?”

19. 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

20. 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?”

21. 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.”

22. “ 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

23. 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

24. 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”

25. 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

26. Thank you !!