Conflict of Interest in Medical Research, Education, and Practice (2009) / Chapter Skim
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6 Conflicts of Interest and Medical Practice
6 Conflicts of Interest and Medical Practice
Pages 166-188
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From page 166... ...
This chapter focuses on physician financial relationships with industry that usually are not intrinsic to medical practice and that can be avoided. These relationships create conflicts of interest when physicians • accept company gifts of various kinds, including meals and drug samples; 166
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From page 167... ...
Because the committee considered financial relationships with industry in the context of physicians' professional obligations, the chapter includes a discussion of professional codes of conduct and statements on conflicts of interest in medical practice from professional societies. The chapter concludes with recommendations for the physician community; health care providers; and pharmaceutical, medical device, and biotechnology companies.
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From page 168... ...
Physician Payment and Conflicts of Interest Researchers and policy makers have devoted considerable attention to the day-to-day incentives for inappropriate clinical practice related to physician payment arrangements. Each major method of paying physicians has the potential to put physicians' primary interest in promoting the best interests of their patients at odds with their secondary financial interests.
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From page 169... ...
The allure of profitable services has led to increased physician ownership of ambulatory surgical, imaging, and endoscopy centers and other free standing facilities such as specialty hospitals. For example, the number of cardiac and orthopedic specialty hospitals serving Medicare patients grew from twenty-one in 1998 to sixty-seven in 2003, the majority of which were for-profit and owned in part by physicians.
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From page 170... ...
Designated health services include clinical laboratory services; inpatient and outpatient hospital services; diagnostic radiology services; radiation therapy services and supplies; durable medical equipment and supplies; prosthetics, orthotics, and prosthetic devices and supplies; home health care services; physical therapy services; outpatient prescription drugs; occupational therapy services; and parenteral and enteral nutrients, equipment, and supplies.
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From page 171... ...
. As discussed below, companies may A press release from PeopleMetrics Rx about a study of the influence of drug sales representatives on physician prescribing practices stated that the study found "that sales representatives must develop personal relationships with their physicians to achieve the highest levels of engagement" and that "emotional components such as friendship with the reps are the strongest indicators of Fully Engaged physicians [which]
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From page 172... ...
. Thirty-five percent received industry reimbursement for costs associated with professional meetings or continuing medical education; and 28 percent received payments for activities such as consulting, serving on a speakers bureau, or enrolling patients in clinical trials.
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From page 173... ...
Thus, it is too early to gauge the effects of these changes on physician relationships with pharmaceutical and medical device companies. Participation of Community-Based Physicians in Clinical Trials As mentioned in Chapter 4, physicians in private office settings are increasingly participating in clinical trials that are sponsored by industry and managed by contract research organizations or research site management organizations.
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From page 174... ...
Community Versus Academic Practice Environment Chapter 5 reported on the extensive relationships between academic physicians and industry and discussed industry promotional activities undertaken in the context of graduate and undergraduate medical education. It reported on studies that suggest that industry relationships and promotional activities (e.g., detailing visits)
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From page 175... ...
In research, the community practice environment is clearly different from the environment in academic medical centers and major teaching hospitals. Although the research may be reviewed in advance by an institutional review board, community physicians may receive no training in the standards of the ethical conduct of research, may have little contact with experienced clinical researchers, and may lack the knowledge needed to review contract or research descriptions provided by a company.
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From page 176... ...
deally, physicians should not accept any promotional gifts or amenities, whatever their value or utility, if they have the potential to cloud professional judgment and compromise patient care" but "[a] s a practical matter, many physicians are comfortable" accepting gifts of modest value that may enhance medical practice or knowledge (p.
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From page 177... ...
The use of drug samples for personal or family use is permissible as long as these practices do not interfere with patient access to drug samples.
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From page 178... ...
The committee found little information about the positions of state medical societies on individual or organizational relationships with medical product companies. The Wisconsin Medical Society announced in 2008 that
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From page 179... ...
The document describes several factors as relevant to determining the legitimacy of such arrangement, including whether • a written contract specifies the nature of the consulting services to be provided and the basis for payment of those services; • a legitimate need for the consulting services has been identified in advance of requesting services and entering into arrangements with consultants; • the criteria for selecting consultants are directly related to the identified purpose and the persons responsible for selecting the consultants have the expertise necessary to evaluate whether the particular health care professionals meet those criteria; • the number of health care professionals retained is not greater than the number reasonably necessary to achieve the identified purpose; • the retaining company maintains records concerning and makes appropriate use of the services provided by consultants; and • the venue and circumstances of any meeting with consultants are conducive to the consulting services, and activities related to the services are the primary focus of the meeting; specifically, resorts are not appropriate venues (PhRMA, 2008, p.
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From page 180... ...
Companies may, subject to certain standards, • have sales representatives make informational visits to physicians and provide modest meals in connection with the visit; • provide financial support to providers of continuing medical education so that they may reduce registration fees for programs; • support professional and scientific meetings at appropriate locations in accord with the guidelines of the organizations supported; • arrange for expert consultants on topics such as the marketplace, patient care, and products; • sponsor speaker programs and provide training and reasonable compensa tion for speakers; • provide scholarships for students and professionals to attend educational conferences; and • provide educational and practice-related items of modest value to physicians. and Human Services, some pharmaceutical companies have already revised their contracting practices.
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From page 181... ...
At the state level, these responses range from laws requiring company disclosure of certain payments to physicians to laws restricting or prohibiting certain relationships. As noted above, some federal agency policies require disclosure of certain physician ownership interests in health care facilities, and MedPAC has proposed a substantial expansion of disclosure of such interests.
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From page 182... ...
The companies also entered into corporate integrity agreements that would involve extensive monitor ing of their consulting needs and arrangements for an 18-month period (DOJ, 2007a)
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From page 183... ...
Academic Detailing and Other Prescriber Outreach Strategies As one alternative to physician reliance on company sales representatives for information, "academic detailing" incorporates techniques that pharmaceutical company representatives use. Programs may use in-person visits to physicians by a clinical pharmacist or physician, provide educational materials and branded items, and offer individualized feedback on performance.
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From page 184... ...
RECOMMENDATION 6.1 Physicians, wherever their site of clinical practice, should • not accept items of material value from pharmaceutical, medi cal device, and biotechnology companies except when a transaction involves payment at fair market value for a legitimate service; • not make educational presentations or publish scientific articles that are controlled by industry or contain substantial portions written by someone who is not identified as an author or who is not properly acknowledged; • not enter into consulting arrangements unless they are based on written contracts for expert services to be paid for at fair market value; • not meet with pharmaceutical and medical device sales repre sentatives except by documented appointment and at the physician's express invitation; and • not accept drug samples except in specified situations for pa tients who lack financial access to medications. Professional societies should amend their policies and codes of profes sional conduct to support these recommendations.
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From page 185... ...
Such arrangements should be documented in contracts with specific tasks and deliverables and should be paid for at fair market value. The recommendations about interactions with sales representatives are slightly different for academic and nonacademic physicians.
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From page 186... ...
For patients with chronic illnesses who lack the ability to pay for medications, a sample should be a stopgap that is accompanied by referral of the patient to a public or pharmaceutical company assistance program that can provide continuity of treatment. If physicians decide to accept drug samples, they should be given to patients who lack financial access to medications in situations in which appropriate generic alternatives are not available and the medication can be continued at little or no cost to the patient for as long as the patient needs it.
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From page 187... ...
. RECOMMENDATION 6.2 Pharmaceutical, medical device, and bio technology companies and their company foundations should have policies and practices against providing physicians with gifts, meals, drug samples (except for use by patients who lack financial access to medications)
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From page 188... ...
, some community physicians might choose to forgo certain relationships with industry that they find difficult to explain and justify. Community physicians who teach medical students or residents off-site would be affected by reforms in the policies of medical schools and teaching hospitals (Recommendation 5.1)
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