Physician assistants and other clinicians frequently encounter vendors, representatives of drug manufacturers, and other commercial interests who wish to gain access to the provider for the purpose of marketing their products and services.
As these interactions have come under increased scrutiny in recent years, health care providers have typically insisted that they can and do make prescribing decisions independent from any commercial influence. Despite this insistence, however, evidence consistently points to the opposite conclusion, repeatedly indicating that pharmaceutical marketing efforts do indeed influence provider decision making.
ARE WE REALLY SWAYED BY FOOD AND OTHER SMALL GIFTS?
Gift giving by vendors has long been controversial, and a notable 2006 article by Brennan and colleagues in the Journal of the American Medical Association summarized some of the strongest evidence up to that time indicating that prescribers are influenced by even casual contact with commercial vendors. The authors noted, "Although physician groups, the manufacturers, and the federal government have instituted self regulation of marketing, research in the psychology and social science of gift receipt and giving indicates that current controls will not satisfactorily protect the interests of patients."1
In the face of widely held prescriber skepticism about the influence of small gifts on their practice, Brennan made a strong case to the contrary. These two points are key:
- Small gifts significantly influence prescriber behaviors. Brennan cited compelling research from the field of psychology, noting that the impulse to "return the favor" exists in the recipient of a gift even when a gift is small and that the token offerings typically provided by vendors can have a powerful impact on the prescriber's behavior.
- Providers' receipt of small gifts from vendors predicts prescribing behavior. Receiving gifts is associated with positive physician attitudes toward pharmaceutical representatives. Physicians who request additions to hospital drug formularies are far more likely to have accepted free meals or travel funds from drug manufacturers. The rate of drug prescriptions by physicians increases substantially after they see sales representatives, attend company supported symposia, or accept samples.1
Their conclusions led Brennan and his coauthors to make several recommendations, foremost of which was ending all gifts to providers from commercial interests, including even gifts with minor monetary value (such as pens or sandwiches). Another key suggestion included ending the direct provision of drug samples to prescribers. This could be replaced by a system in which patients might receive vouchers from either the clinician office or the manufacturer. Such a system would decrease the contact between sales representatives and prescribers.
AREN'T DRUG SAMPLES JUST HELPFUL GIFTS?
Related to the second recommendation, many providers believe that their prescribing is not influenced by contact with sales representatives; and this assertion is frequently made with respect to free drug samples, which providers argue helps them to help patients who otherwise could not afford needed medication. However, a 2008 piece by Miller and colleagues in the Southern Medical Journal thatlooked at the common practice of drug companies providing free drug samples to clinic-based prescribers in the United States cited data showing that the practice had a very different effect:2
• Free drug samples are frequently used in medical practice.
• Physicians were more than three times more likely to prescribe generic medications to uninsured patients after drug samples were removed from the clinic.
• The proportion of generic prescriptions given to Medicaid patients was not affected by the presence of free drug samples.
• Free drug samples may lead to higher costs for uninsured patients by encouraging physicians to write prescriptions for branded drugs.2
Miller also found that prescribers who receive free drug samples are more likely to skip over less expensive first-line medications and instead write prescriptions for expensive, heavily promoted, and widely advertised drugs.2
CONFLICT OF INTEREST? ME?
Drug detailing describes the practice of visits to clinicians by pharmaceutical sales representatives. According to the Institute of Medicine (IOM), drug detailing accounts for a huge amount of pharmaceutical company annual spending on product promotion: 36% of $57.5 billion in 2004.3
The IOM has noted that an important starting point for examining conflict of interest issues is establishing a common definition. The IOM defined conflict of interest as
a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.
To avoid common misunderstandings of the concept that can lead to misplaced and ultimately ineffective or counterproductive policies, the committee stresses the importance of each of the three main elements of a conflict of interest: the primary interest, the secondary interest, and the conflict itself.3
Studies have indicated that residents and medical students report frequent contact with pharmaceutical representatives, often noting that their medical education lacked guidelines for managing these interactions.
Consistent with the data available for providers after residency, medical students and residents also note that while they believe that their colleagues' prescribing behaviors are impacted by interactions with drug representatives, they do not believe that their own prescribing practices are so influenced.4 As noted earlier, however, the persistent notion held by providers that they are immune from being influenced by contact with pharmaceutical representatives has been consistently found to be incorrect. The IOM report noted the following:
Overall, research suggests that drug company representatives may influence prescribing patterns and requests for additions to hospital formularies. The effects appear to be modest but consistent across various kinds of research and disciplines. One review concluded that the "pharmaceutical industry has a significant presence during residency training, has gained the overall acceptance of trainees, and appears to influence prescribing behavior"... Another review (which was not limited to educational settings) concluded that detailing "affects physician prescription behavior in a positive [i.e., the more detailing that there is, the more of an effect that it has] and significant manner"....3
VALUING INDUSTRY
CONTRIBUTIONS
The IOM report also examines the conflict of interest that can arise from provider engagement and contact, while noting that pharmaceutical companies can play (and have played) a meaningful role in medicine.3 This paradox has a long history, as noted in this excerpt from the IOM report:
More than a century ago, a review in the Chicago Medical Recorder of Merck's Manual of the Materia Medica (now the Merck Manual of Diagnosis and Therapy) observed: "[a]lthough this little book is gotten out by a manufacturing firm and with some view towards its advertising value, it nonetheless is of such merit that it is deserving of mention in this column" ... Then, as now, recognition of the value of industry contributions can coexist with unease about commercial motivations and potential bias.3
Also in the IOM report is the acknowledgment that some contact with pharmaceutical representatives can be appropriate and add value to
a student's medical education:
Some interactions with industry can have educational value, for example, when an industry scientist participates in a seminar on drug development strategies or when a device company representative provides supervised training on a complex and innovative medical device that has recently been approved for marketing. Other examples may include unrestricted grants to academic medical centers that support student or resident research stipends or participation in scientific conferences. On a much larger scale, universities have benefited from company gifts for buildings, research programs, and auditoriums.3
WHAT THE IOM RECOMMENDS
Even with these qualifications, the IOM report raises concerns about potential conflict of interest related to almost all types of contact between pharmaceutical representatives and health care providers. The report proposes following recommendations from the American Association of Medical Colleges (AAMC) to ameliorate the impact of such contact:
• To protect patients, patient care areas, and work schedules, access by pharmaceutical representatives to individual physicians should be restricted to nonpatient care areas and nonpublic areas and should take place only by appointment or invitation of the physician.
• Involvement of students and trainees in such individual meetings should occur only for educational purposes and only under the supervision of a faculty member.
• Academic medical centers should develop mechanisms whereby industry representatives who wish to provide educational information on their products may do so by invitation in faculty-supervised structured group settings that provide the opportunity for interaction and critical evaluation. Highly-trained industry representatives with MD, PhD, or PharmD degrees would be best suited for transmitting such scientific information in these settings.3
JAAPA
Jim Anderson is a clinical informatics educator for University of Washington Medicine—IT Services and a member of the clinical faculty of the MEDEX Northwest PA program at the University of Washington School of Medicine in Seattle. He is a member of the JAAPA editorial board.
F.J. Gianola, PA, and Jim Anderson, PA-C, department editors
REFERENCES
1. Brennan TA, Rothman DJ, Blank L, et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA. 2006;295(4):429-433.
2. Miller DP, Mansfield RJ, Woods JB, et al. The impact of drug samples on prescribing to the uninsured. South Med J. 2008;101(9):888-893.
3. Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice; Lo B, Field M, eds. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009.
4. Zipkin DA, Steinman MA. Interactions between pharmaceutical representatives and doctors in training: a thematic review. J Gen Intern Med. 2005;20(8):777-786.