Conflict of Interest in Physician-Industry Relationships

1. Conflict of Interest in Physician-Industry Relationships

2. Objectives • Define conflict of Interest • Recognize situations where conflict of interest may occur in the physician-industry relationships • Cite strategies on managing potential conflict of interest

3. Conflict of Interest Definition American Heritage Dictionary: “A conflict between a person's private interests and public obligations.” A potential conflict of interest occurs when there is a possibility that an individual’s private interests, or his or her family’s interests, may influence the individual’s professional actions, decisions, or judgment

4. Physician Conflict of Interest • Physician (individual) conflict of interest may arise when there is conflict between the interest of physician and those of the patient (or patients) • There exists evidence in the literature which shows that interactions between medical professionals and industry may lead to compromise of professional values and negatively effect the physician-patient relationship

5. Example 1: “Qui tam” The Lupron Case (1997) • Relationships between TAP pharmaceuticals and various urologists were questioned regarding use of Lupron in the treatment of prostate cancer • TAP encouraged urologists to bill Medicare at the average wholesale price which they received discounted or free • TAP also employed doctors as “consultants”, took them on free trips to attend seminars, and awarded unrestricted educational grants

6. Example 1: The Lupron Case (1997) • The physicians did not bill TAP for their time, nor did they prepare any reports • Federal prosecutors charged TAP with criminal violations of the Prescription Drug Marketing Act • TAP settled with the government and paid $290 million in criminal fines plus $585 million in civil penalties • The whistle-blowers received nearly $100 million of the total damages

7. Example 2: Dennis Selkoe (1998) • A Harvard scientist at Massachusetts General Hospital • NIH report endorsing blood test for Alzheimer’s • Selkoe signed the report but did note that • He helped found Athena • Test was manufactured by Athena • When Athena went public in 1993, Selkoe had shares worth $3 million

8. Physician-Industry Relationship • Physicians goals are to provide good patient care • Pharmaceutical companies’ goals are to maximize product sales • Physicians are main conduit for sales, which have made them an ideal target for marketing strategies • Industry may disseminate certain information that may not necessarily correspond with information the providers need

9. Physician-Industry Relationship • Growth in promotional activities has also been accompanied by a rise in industry’s funding of research and education • 60% of biomedical research and development is privately funded • 70% of clinical trials funding is funded by pharmaceutical companies • Industry holds more than half of the costs of formal programs in CME

10. Physician-Industry Relationship • Industry spends about $12 billion annually on gifts and payments to physicians • Examples of industry practices which can create conflict of interest: • Food • Gifts (pens, books) • Drug samples • Support of medical education activities • Speakers bureaus and consulting fees • Research grants • Contact with trainees come early and adheres as physicians move to practice

11. Reality check • Prescribing practices of physicians are commonly influenced by subtle and obvious marketing messages and gifts • Physicians do not recognize or admit to any changes in their practice of medicine due to these influences • In a study of medical residents, 61% were confident that drug companies did not influence their practice, while 16% were equally confident that their colleagues were not influenced by those practices

12. Students Interactions with Industry • Medical student-industry interactions are common • Students are relatively permissive regarding the acceptance of gifts • Students underestimate the influence of these gifts on their behavior It is important as a student to understand physician-industry relationships and the potential risk for conflict of interest

13. Reality check- Medical Students • In a study of medical students in the US: • 93% were asked to attend at least one sponsored lunch • 69% believed gifts would not influence their practice • 80% believed they were entitled to gifts • 86% of the students who thoughts gifts at a certain amount were inappropriate had accepted one

14. “To maintain integrity and independent-decision making, physicians must ensure that they maintain an impartial relationship with industry representatives free of any influences”

15. Managing Conflict of Interest • Strategy for managing conflict of interest : • Recognition • Disclosure • Management

16. Recognition • Physicians need to recognize that gifts, regardless of the size do influence behavior and a self-serving bias distorts the way individuals perceive themselves • Conflict of interest policies should help individuals recognize potential conflict of interest situations • Physicians need to be aware of laws, ethical guidelines, and institutional policies and follow them.

17. Disclosure • Disclosure: • Financial relationships with industry • Research funding and sponsored studies BUT • Good intentions are not sufficient given the problem of perception vs. reality, therefore when a conflict of interest is reported, it needs to be carefully reviewed by the appropriate individuals or committee

18. Disclosure Interpretation • Studies show that the disclosure of a competing interest in an article affects readers’ perceptions of its interest, importance, validity, relevance and believability • Assessment of the quality of the article provides important information (CONSORT statement)

19. Management • Elimination of practices that have little or no added clinical value e.g. gifts, free lunches • Management of reported conflict of interest to minimize or eliminate the conflict: • Public disclosure • Independent review • Modifying research plan • Disqualifying participation

20. Management • Elimination of practices that have little or no added clinical value e.g. gifts, free lunches • Management of reported conflict of interest to minimize or eliminate the conflict: • Public disclosure • Independent review • Modifying research plan • Disqualifying participation

21. Summary • Physicians should be aware that conflict of interest exists in their relationships with industry • Physicians should learn to eliminate or reduce these conflicts in the interest of their patients

22. Resources • National Institutes of Health http://grants.nih.gov/grants/policy/coifaq.htm • American Association of Medical Colleges http://www.aamc.org/research/coi • Association of American Universities http://www.aau.edu/research/conflict.cfm • Council on Government Relations, Financial Conflicts of Interest http://www.cogr.edu/docs/COIFinal.pdf