Conflict of Interest in Physician-Industry Relationships APGO Interaction with Industry: A Medical Student Guide Conflict of Interest in Physician-Industry Relationships Rev. 10/21/2014

Objectives Define conflict of interest Recognize situations where conflict of Interest may occur in physician-industry relationships Cite strategies to help manage potential conflicts 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 individuals private interests, or his or her family’s interests, may influence the individual’s professional actions, decisions or judgment. A conflict of interest involves the abuse of trust.

Physician Conflict of Interest Physician (individual) conflict of interest may arise when there is conflict between the interest of the physician and those of his/her patients. Some evidence in literature shows that interactions between physicians and industry representatives, when not properly managed, may lead to the compromising of professional values or negative effects on the physician-patient relationship.

Conflict of Interest Levels Individual Departmental – financial interest of the department has the possibility of influencing the faculty members behavior for the gain of the department Institutional – financial interest of institutional official or institution might appear to affect institutional policies governing the conduct, review and oversight of research. Society – Interest of society may potentially unduly influence some individuals

Example 1: Free Gifts It is a busy day in the office, but you have agreed to speak for a minute to a pharmaceutical representative who has stopped by to drop off some samples of a new quinolone antibiotic called Ubiquinone. Knowing your interest in golf, he has brought you golf balls emblazoned with the letter “U,” and also invites you to a round of golf at the country club this weekend. Would you accept the golf balls? Would you accept the invitation? Would the public know? (From: “Really Difficult Problems in Medical Ethics” and NoFreeLunch presentation)

Physician/Pharmaceutical Relationship Note that in 2012, the pharmaceutical industry spent more than $27 million on marketing to physicians and that 84% of US physicians reported receiving drug samples, payments, meals, other gifts, and/or travel from the pharmaceutical industry. (Pew Prescription Project 2014) Physicians have gradually started to question the ethics and integrities of such interactions as well as the impact drug rep visits have on their prescribing habits and on patients’ health. In 2010, the Sunshine Act was signed into law and requires disclosure to the public of all financial relationships between physicians and medical device companies and pharmaceutical manufacturers.

Example 2: Conflict of Interest You have secured commercial support for your activity from company XYZ. Can the commercial interest (XYZ) give you a list of speakers that could address your topic? Answer: It is ok if they provide a list of potential speakers. Can the commercial interest (XYZ) tell you who must speak or they will not provide support for the program? Answer: No, they cannot tell you who should speak.

Physician-Industry Relationship A physician’s goal is to provide good patient care. Pharmaceutical and medical device companies develop, produce and market drugs and products to treat various ailments or disorders. Their goals include maximizing product sales. Physicians are a main conduit for sales, which have made them an ideal target for marketing strategies. Industry may disseminate information that may not necessarily correspond with information that physicians need. Growth in promotional activities has been accompanied by a rise in industry’s funding of research and education.

Physician-Industry Relationship In 2004, industry spent about $57.5 billion on promotional activities (including $20.4 billion for detailing) In 2007, industry spent $1.2 billion on support for CME accounting for more than half of the costs of formal programs in CME As much as 60% of biomedical research and development is privately funded As many as 70% of clinical trials are funded by pharmaceutical companies

Codes of Ethics Interactions with Industry The Pharmaceutical Research and Manufacturers of America (PhRMA) established the Code on Interactions with Healthcare Professionals in 2002. It was revised in 2009. The American Medical Technology Association (AdvaMed) created the Code of Ethics on Interactions with Health Care Professionals in 2003. It was also revised in 2009. These codes are reviewed frequently.

Physician-Industry Relationships 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 can begin early and follows as physicians move to practice

Reality Check Prescribing practices of physicians may be influenced by both subtle and obvious marketing messages and gifts. Physicians may 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 only 16% were equally confident that their colleagues were unaffected by those practices. (Ref: Am J Med 110:2001;551- 557)

Students Interactions with Industry Medical student-industry interactions can be common. Students may tend to be permissive regarding the acceptance of gifts. Students underestimate the influence of gifts may have 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 2011, a comprehensive review of US medical students reported: 89 - 98% were asked to attend at least one sponsored lunch 90% received educational materials from industry 69% believed gifts would not influence their practice 80% believed they were entitled to gifts 86% of the students who thought gifts of a certain amount were inappropriate had accepted one (Austad et al PLoS Med 8:e10001037; 2011)

National Survey Shows Medical Students and Residents Have Frequent Interactions with Pharmaceutical Companies 40%–100% of medical students reported interactions 13%–69% reported belief that industry gifts influence prescribing Eight studies reported correlation between frequency of contact and favorable attitudes. Students were more approving of gifts to physicians or medical students than to government officials. Certain attitudes appeared to change during medical school Clinical students (53%–71%) more likely than pre-clinical students (29%–62%) to report that promotional information helps to educate about new drugs.

“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 : Recognition Disclosure Management

Recognition Physicians need to recognize that gifts, regardless of the value, may influence behavior and a self-serving bias distorts the way individuals perceive themselves. Conflict of interest policies are developed to help individuals recognize potential conflict of interest situations. Physicians need to be aware of laws, ethical guidelines and their 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 v. 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 Eliminate practices that have little or no added clinical value (e.g. gifts, free lunches). To be free from commercial bias: if one product is mentioned, then all options should be discussed. Manage 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 may exist in their relationships with industry if relationships are not properly managed. Physicians should learn to eliminate or reduce these conflicts in the interest of their patients. Become familiar with your organization’s conflict of interest and industry relations policies. See also APGO’s Industry Relations Policy as a reference. https://www.apgo.org/about/industry.html (hyperlink will be active in presentation mode)

Resources (hyperlinks will be active in presentation mode) APGO Industry Relations Policy (https://www.apgo.org/about/industry.html) 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) National Institutes of Health (http://grants.nih.gov/grants/policy/coifaq.htm) PhRMA Code http://www.phrma.org/principles-guidelines/code-on-interactions-with-health- care-professionals) AdvaMed Code (http://advamed.org/issues/1/code-of-ethics)