Conflict of Interest How do relationships influence your professional and clinical judgment?

1. Conflict of InterestHow do relationships influence your professional and clinical judgment? Dr. Gordon Self, Chief Mission and Ethics Officer and Josh Stachniak, General Counsel and Corporate Director of Risk Management

2. Objectives To explore how relationships impact professional and clinical judgment. To provide an ethical framework for assessing appropriate relationships. To understand how legislation impacts conflicts of interest within the public sector

3. Disclosure We have no relationship that could be perceived as placing us in a real or apparent conflict of interest in the context of this presentation

4. History of Conflict of Interest policy Caritas Health Group policy Conflict of Interest Policy/Relationship with Industry Conflicts of Interest Act (Alberta) It is important to note that this is not “new”, as an organization we have identified the value in proactively addressing conflicts and supporting our staff in principle based prudential decision making. The environment is always evolving, so our policy also evolves over time.

5. Why is it important to discuss conflicts? Health care is a relational industry: relationship with patients, with other clinicians, with AHS and Alberta Health and with industry/service providers The nature of those relationships is critical to effective, efficient and high quality service delivery There are already existing professional standards and code of conduct statements, CPSA, CMA, and regulatory standards regarding tendering, RFP process, internal audit practices, etc The Conflicts of Interest Act (Alberta) is newly applicable to Covenant Health and its staff We still receive many questions about what constitutes a conflict and how to handle certain situations (i.e. a gift from a vendor)

6. What is a conflict of interest? Covenant Health policy states: A divergence between a person’s own and/or their family’s personal, financial or business interests and the person’s professional obligations to Covenant Health such that an independent observer might reasonably question whether the person’s professional actions or decisions are determined by considerations of personal gain, financial or otherwise. This definition extends to actual, potential and perceived conflicts of interest.

7. Other thoughts on conflict of interest CARNA: Nurses identify and address conflicts of interest. They disclose actual or potential conflicts of interest that arise in their professional roles and relationships and resolve them in the interest of the needs and concerns of persons receiving care. CPSA: A regulated member must resolve any real, potential or perceived conflicts of interest in the best interest of the patient. Aristotle: “I count him braver who overcomes his desires than him who conquers his enemies; for the hardest victory is over self.” 

8. Conflicts of Interest Act (Alberta) Covenant Health is subject to the Conflicts of Interest Act (effective April 30, 2019) What does the Act require of persons acting on behalf of Covenant Health? To act impartially in carrying out duties for Covenant Health. To not act in self-interest or further their private interests by virtue of their position or through the carrying out of their duties with Covenant. To appropriately and adequately disclose real and apparent conflicts of interest. To avoid a conflict of interest or apparent conflict of interest due to the acceptance of gifts. To avoid a conflict of interest or apparent conflict of interest due to a person’s involvement in an appointment, business, undertaking or employment, other than their duty to Covenant Health.

9. Not just an individual matter of conscience Implications: For health care organizations who employ or privilege personnel who act in their name; For Catholic health care organizations, especially given our longstanding tradition in serving the poor, and commitment to the common good; For Covenant Health in particular. Thus, how do relationships with industry align with our values of social justice, stewardship, integrity, collaboration?

10. What hat do I have on? • We all play many different roles in our life: physician, nurse, parent, spouse, friend, colleague, partner, sibling, child etc. • Declaration of Conflict • A critical aspect of recognition of conflict is to identify proactively what role you are acting in and what others roles you actively possess which may result in a conflict. • Are you representing Covenant Health in your role? • Key questions: • Are you acting for, or on behalf of Covenant Health? • Are you directly or indirectly controlling or directing Covenant Health funds? • Are you authorized to bind Covenant Health to an Agreement? • Critical to also ask, not what hat you think you have on, but what hat does the person you are interacting with think you have on.

11. Is there a need for continuing education and scrutiny of conflicts of interest? Previously largely unregulated - expectation to self-monitor behaviour What’s changed? PhRMA – lobby group’s own 2002 voluntary guidelines Increasing body of research reported in literature indicating: Industry-sponsored “education” is often biased and intended primarily to improve product sales; Industry-sponsored research lacks objectivity and is often designed in such a way as to yield beneficial results, with negative results downplayed, spun positively or suppressed altogether; Industry’s relentless marketing tactics and gifts/payments unduly influence physician behaviour and decision-making Marcia Angell, “Industry-Sponsored Clinical Research: A Broken System,” Journal of the American Medical Association 300 (Sept 3, 2008): 1069-71.

12. How pervasive are gifts/payments? Eric Campbell, et al., “A National Survey of Physician Industry Relationships,” New England Journal of Medicine 356 (April 26, 2007): 1742-1750. 3167 surveys distributed to physicians in six specialties (anesthesiology, cardiology, family practice, general surgery, internal medicine, pediatrics) practicing in diverse settings/locales. 52% response rate to approx. 50 item survey “Which of the following have you received in the last year from drug, device, or other medically related companies?” Food or beverages in the workplace; Drug samples; Honoraria for speaking; Payment for consulting; Payment for service on advisory board; Payment in excess of costs for enrolling patient in industry-sponsored trials; Costs of travel, time, meals, lodging or other personal expenses for attending meetings; Gifts received as a result of prescribing practices; Free tickets to cultural or sporting events; Free or subsidized admission to meeting or conferences for continuing medical education

13. Frequency of Physician-Industry Relationships According to Benefits Received, Campbell et al

14. Frequency of industry rep interactions, average per month Family practitioners (16x), Internists (10x), Cardiologists (9x), Pediatricians (8x), Surgeons (4x), Anesthesiologists (2x) 90,000 pharmaceutical reps to meet approx 567,000 US physicians (1 rep : 6.3 physicians) Campbell, et al IMS Health monitoring of industry spending to physicians - in 2004, pharmaceutical industry spent on average $10,000 per practicing American physician on free meals, free continuing medical education training, free trips to conferences, and payments for various services (consulting and speaking) Pharma also gave the average US physician $21,000 in free drug samples Total, $23.7 billion in 2004, twice as much as six years earlier John Dudley Miller, “Study Affirms Pharma’s Influence on Physicians,” Journal of National Cancer Institute 99 (Aug 1, 2007): 1148-1150, at 1148.

15. Influencing your clinical judgment? Despite pervasive activity, most physicians insist that industry gifts/payments do not unduly influence their judgment L. Lewis Wall and Douglas Brown, “The High Cost of Free Lunch,” Journal of Obstetrics & Gynecology 110 (July 2007): 169-173. M.A. Morgan et al, “Interactions of Doctors with the Pharmaceutical Industry,” Journal of Medical Ethics 32 (October 2006): 559-563 Susan Chimonas, Troyen Brennan and David Rothman, “Physicians and Drug Representatives: Exploring the Dynamics of the Relationship,” Journal of General Internal Medicine 22 (February 2007): 184-190 Do you agree?

16. How about unconsciously? How would you even know? Older studies (next slide) suggest gifts/payments create conflicts of interest that unconsciously bias physicians leading to: Inappropriate use and over-utilization of medical devices and drugs; Reduced generic prescribing; Increased overall prescription rates and thereby increased expenditures on prescription drugs; Formulary requests for drugs with few or no advantages over existing drugs; Quick uptake of the newest, most expensive devices and drugs, including those of only marginal benefit over existing options with established safety records

17. Not a new question in the literature Jerry Avorn et al., “Scientific Versus Commercial Sources of Influence on the Prescribing Behavior of Physicians,” American Journal of Medicine 73, (July 1982): 4-8 Lurie et al., “Pharmaceutical Representatives in Academic Medical Centers: Interaction with Faculty and Housestaff,” Journal of General Internal Medicine 5 (May-June 1990): 240-243 James Orlowski and Leon Wateska, “The effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns,” Chest 102 (July 1992): 270-273 Joel Lexchin, “Interactions Between Physicians and the Pharmaceutical Industry: What Does the Literature Say?” Canadian Medical Association Journal 149 (Nov 15, 1993): 1401-1406: T.S. Caudill et al., “Physicians, Pharmaceutical Sales Representatives, and the Cost of Prescribing,” Archives of Family Medicine 5 (April 1996): 201-206

18. If not unconscious, then non-rational? A more recent review of 29 empirical studies providing evidence that: Meetings with pharmaceutical reps were associated with requests by physicians for adding the drugs to the hospital formulary and changes in prescribing practice; Attending sponsored continuing medical education events and accepting funding for travel or lodging for educational symposia were associated with increased prescription rates of the sponsor’s medication; Attending presentations given by pharmaceutical rep speakers was associated with what author describes as “non-rational prescribing” Ashley Wazana, “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” Journal of the American Medical Association 283 (Jan 19, 2000); 373-380

19. Applying social science research Social science research on conflict of interest applied to physician-industry practices show: Gifts and payments to physicians have an unconscious influence and create a strong feeling of reciprocity; Jason Dana and George Loewenstein, “A Social Science Perspective on Gifts to Physicians From Industry,” Journal of the American Medical Association, 290 (July 9, 2003): 252-255.

20. The power of reciprocity A substantial body of evidence that gifts produce a feeling of indebtedness and obligation to repay on the part of the recipient. The “norm of reciprocity” (Gouldner, 1960) or the “rule of reciprocation” (Cialdini, 1993) is a pervasive finding across cultures and societies, both primitive and advanced (Mauss, 1954; Lévi-Strauss, 1969): Feelings of obligation to reciprocate are unrelated to the value of the gift (Mauss, 1954; Lévi-Strauss, 1969); Gifts produce a feeling of obligation even when the giver is disliked (Regan, 1971); Gifts that are unwanted or unsolicited create feelings of obligation to the giver (Cialdini, 1993), a principle that is well-known to marketers; Reciprocal giving is often unequal - the return gift may have a much higher value than the original gift (Cialdini, 1993; Lévi-Strauss, 1969). Marketers know that giving can be profitable. Robert H. Margolis, “What Social Science Research Teaches about Financial Incentives form Industry,” University of Minnesota, April 2008, available from the American Academy of Audiology, at http://www.audiology.org/about/membership/ ethics/Documents/SocialScienceResearch2008.pdf (accessed Feb 7, 2011).

21. Subtle/insidious, versus over-the-top gifts A small gift can affect a doctor's decision-making as much as an all-expenses paid trip.  "With a big gift, you're on guard right away. The very act of giving a small gift creates a cultural sense of obligation.  Yet it is subtle.  Your guard isn't up.“ Dr. Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics See also: D. Katz, AL Caplan, JF Merz, “All gifts large and small: toward an understanding of the ethics of the pharmaceutical industry gift-giving”. American Journal of Bioethics 2003;3(3): 39-46. No need for hard sell.  A friendly, collegial relationship with a few studies, drug samples, or pizza lunch – a sense of reciprocity will develop

22. Setting minimal amounts The finding that the effect of a gift is unrelated to its value is particularly important in view of the common policy of establishing a threshold value below which gifts are acceptable and above which they are not. The finding that gifts of minimal value can have similar influence to more expensive ones suggests that policies of this sort are not likely to avoid or reduce the harmful influences. In fact, it can be argued that gifts of small value are more harmful because industry can give a lot more of them. Meals the most harmful form of gift ? “Food is the most commonly used technique to derail the judgment aspect of decision making” Katz et al.

23. So why do we have gift “limits” • The Covenant Health Summary Resource Document and Position Statement states that: • Acceptance of cash or cash equivalents as a gift is strictly prohibited. • The value of a single tangible gift permitted by this section shall not exceed $100. The cumulative maximum cash value limit for tangible gifts permitted by this section from a single source vendor in a calendar year is $200. • The value of a single event invitation permitted by this section shall not exceed $500. The cumulative maximum cash value limit for event invitations permitted by this section from a single source in a calendar year is $1000. • Does this mean that gifts below these thresholds are ok? • No, prudential judgment is still required.

24. What about gift cards? • The Covenant Health Summary Resource Document and Position Statement states that: • Acceptance of cash or cash equivalents as a gift is strictly prohibited. • What does this mean for gift cards? • The policy is looking to eliminate gift cards as gifts received by individual staff. • Cash and gift cards are difficult to track • May carry CRA implications as taxable income • What about gift cards given to a group of staff (for team coffee, pizza lunch, etc.) • Cash or Gift cards can be donated to the Covenant Foundation • Less of a direct individual benefit if applied to staff generally or to a larger team

25. Covenant Health’s policy – what are we trying to achieve? A balanced, reasoned approach; Affirmation of role of industry, but need to preserve integrity of professional and clinical judgment; Acknowledgment of the issues – get people talking/reflecting on their behaviour; Exercise of a prudential judgment; An expectation that people will be able to defend their decision-making; Compliance with law;

26. COIs sometimes unavoidable…but still must be managed

27. Just keep busy and focus on outcomes

28. “Prudential personalism” Fr Kevin O’Rourke helped retrieve the work of St. Thomas Aquinas “Prudential” – in virtue tradition derived from Aristotle and Aquinas. Prudence means bold deliberation and discernment. Prudence is rooted in freedom, autonomy, creativity rather than mere obedience It is intelligent in asking “why” rather than merely “what” Virtue of prudence requires perfection of multiple human abilities, including memory, imagination, foresight, counsel, firmness of purpose, and common sense “Personalism” - a teleological perspective – the goal or purpose is the flourishing of the human person, and by extension, the organization A personalistic ethic is one that is based in the real good and needs of actual human persons, these good and needs can be verified scientifically and experientially, and they can change from on historical or cultural context to another

29. Opportunity to mentor others Our Commitment to Ethical Integrity: Stewardship: “We will ensure resources are available to promote sound decision-making by all persons in the organization” A shared commitment. One such resource is the role of mentorship and setting a positive example Question: If physicians have had lots of experience with dealing with industry, then how can they help teach others in the organization to preserve integrity of professional decision-making?

30. Discussion Questions: When do you know you are being unduly influenced? How do you manage this? What does this mean for my current practice? What will promote better understanding and compliance?