+ Conflict of Interest in Physician-Industry Relationships

+ 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

+ 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

+ 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

+ 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

+ 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

+ 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

+ 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

+ 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

+ 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

+ 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

+ 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

+ 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

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

+ Managing Conflict of Interest Strategy for managing conflict of interest : 1. Recognition 2. Disclosure 3. Management

+ 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.

+ 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

+ 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)

+ 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

+ 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

+ 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

+ Resources National Institutes of Health American Association of Medical Colleges Association of American Universities Council on Government Relations, Financial Conflicts of Interest