The relationship between paediatric practitioners and ‘industry’

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BACKGROUND

Paediatric practitioners (practitioners) interact regularly with ‘industry’, which for present purposes includes representatives from commercial organizations, the pharmaceutical industry, medical device manufacturers, nutritional and health care product developers, as well as service suppliers. Practitioners depend on industry to produce and distribute the products and services essential to medical practice. One national survey conducted in the United States found that the vast majority of physicians (94%) reported having relationships with industry, with physicians in private or group practices meeting with industry sales representatives more frequently than physicians in hospitals and clinics [1]. In these interactions, physicians believe themselves to be immune to industry influence, although colleagues are not always credited with the same immunity [2].

The industry spends billions of dollars annually employing representatives to meet with physicians, with the goal of increasing profits [3]. The public is aware of such marketing efforts, with 59% of participants from one study responding that industry influences doctors’ prescribing practices, and 54% rating ‘gifts’ irrelevant to medical practice as either inappropriate or extremely inappropriate [4][5] The present practice point outlines some important potential concerns for practitioners in this relationship, along with ethical considerations, existing guidelines and recommendations for how to negotiate at times difficult interactions with industry. Considerations around industry-sponsored research, while very important, are beyond the scope of this practice point.

The paediatric practitioner’s role is to provide the best care for infants, children and adolescents, using current evidence-based knowledge, while making a reasonable living. Industry’s role is to provide safe and effective health care products while returning a profit to company shareholders [6]. Both practitioners and patients depend on industry to develop new products and bring them to market, and busy practitioners often rely on industry representatives for product information. However, practitioners must remain aware of potential biases in the information presented by industry representatives and critically appraise the current literature as part of routine practice, always recognizing that an industry representative’s goal is to portray their product favourably [7]. Occasionally, product information is conveyed over a meal or accompanied by a trinket with the company logo. While this may be how business is transacted in other sectors of the economy, it may not be appropriate in the medical setting. Practitioners are responsible for providing evidence-based medical care that has not been biased by marketing.

In any marketing relationship, giving even a token ‘gift’ can create a sense of obligation that may prove ‘influential’ [8]. Patients might well question whether a practitioner has the patient’s best interests at heart when the practitioner writes a prescription for a medication using a pen bearing the manufacturer’s logo. It could be even more problematic for patients to learn that this company covered expenses for a medical meeting to inform practitioners about their latest product. The practitioner’s first duty is to their patients, while industry’s duty is to their shareholders. It is important to bear this distinction in mind when considering ethical ramifications of the practitioner–industry relationship.

ETHICAL CONSIDERATIONS

Beneficence

The practitioner, as fiduciary, has some degree of power to exercise on behalf of each patient (or beneficiary), and a duty to act in their best interests. Practitioners must continually ensure that their self-interest is not a factor in relationships with patients and that the vulnerability of patients is never exploited [9]. With this privileged relationship comes an ethical responsibility to conduct a stringent arm’s–length relationship with industry.

Professionalism

Personal integrity is essential to self-respect and professional reputation. By and large, physicians do not feel they are personally influenced by industry [2]. However, whether or not a physician’s relationship with industry has influenced prescribing practice is not the key question. The fact that this relationship is capable of influencing medical practice is enough to warrant close scrutiny [8].

The primary motivation for industry gift-giving is to create an expectation of reciprocity. Such gifts can compromise objectivity, professional behaviour and the respect of patients, parents or colleagues. Gifts or other inducements that do not benefit patients are intended to influence behaviour and should never be accepted [10]. Even token gifts such as pens, mugs or pads of paper, where the primary purpose is to display the company logo, may adversely impact the trust of patients and their families [11].

Practitioners are mentors and role models for students, trainees and junior colleagues, some of whom are easily influenced. It is in everyone’s best interest to ensure that practitioner relationships with industry are always transparent and ethically justifiable.

Non-maleficence

It is all too easy for practitioners to find themselves in a conflict of interest (COI) or to experience competing interests. These interests may result in an actual COI, a perceived COI or a potential COI, defined as: ‘a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity’ [12]. Relevant commercial ties may be difficult to define clearly. Income received personally or paid to one’s institution by a company whose product is being prescribed is a clear example. Another example is prescribing a product from a company in which you are a shareholder. A relevant COI may result in practitioners considering their own interests ahead of their patients’ and is not always as clearly defined as the examples given here. As noted, small incentives can create expectations and reciprocal impulses that are never made explicit. A perceived COI can lead to loss of trust by patients, parents or other health care professionals. Harming the patient–practitioner relationship is too great a risk: any real or potential COI must be disclosed and resolved in the best interest of patients. Transparency is the minimum standard in most developed countries [6][13].

The industry provides ‘free samples’ to help sell a product. This particular marketing technique is employed because it establishes a ‘status quo bias’, where physicians and patients do not wish to change medications if they are working [14]. Sometimes families cannot afford a specific treatment, but if the free sample is the standard of care and a child would otherwise not receive treatment, then sample medications may be appropriate if provided for the entire course of treatment.

REGULATIONS

Guidelines have been developed by various governing bodies to navigate the practitioner–industry relationship [15]-[18], and it is important that practitioners familiarize themselves with both local and national policies.

The Canadian Medical Association (CMA) guideline identifies the physician’s obligation to disclose relevant ties to industry and the need to resolve any COI in favour of patients. The guideline specifically states: “Practising physicians should not accept personal gifts of any significant monetary or other value from industry” [15]. The CMA guideline has been endorsed by the Royal College of Physicians and Surgeons of Canada (RCPSC) [16], the Canadian Paediatric Society [18], and many local health care institutions. The CMA regulations may not go far enough because, as has been demonstrated, even small gifts can foster a sense of obligation on the part of practitioners [2].

In keeping with the CMA guideline, RCPSC policy limits continuing medical education (CME) sponsorship to “… modest meals or social events that are held as part of a conference or meeting” and to funding faculty only for “reasonable honoraria and reimbursement for travel, lodging and meal expenses” [15]. They emphasize that “Physicians must be vigilant in discerning the difference between education and marketing” [16]. To help deal with these concerns, accrediting bodies in most industrialized countries have recommended an educational approach [19]. In one review of 10 studies, educational interventions were found to inform the attitudes of residents, medical students and faculty toward industry [19]. Another study confirmed these findings but identified that, despite familiarity with their Institution’s guidelines limiting interactions with industry, >20% of physicians rated accepting dinner at a modest restaurant with no educational component as appropriate, while nearly 10% rated the acceptance of an industry-funded vacation as appropriate [20].

The Association of American Medical Colleges has proposed stringent guidelines to govern the interactions of physicians working in academic institutions vis à vis industry [17]. Developing a set of comparable guidelines would be beneficial for regulating these interactions in private practice as well.

RECOMMENDATIONS

The role of the paediatric practitioner is to act in the best interest of patients. With regard to relationships with industry:

• Remember that industry is, first and foremost, in the business of selling products and services.
• Fully evaluate information provided by industry for scientific merit. Evaluation means exercising due diligence in investigating the risks and benefits of new treatments and keeping abreast of the evidence-based literature concerning available treatment options.
• Fully disclose any relevant commercial ties with industry to patients in relation to prescribing practice.
• Do not accept gifts, inducements or even small tokens (e.g., pens, mugs) which do not benefit patients.
• Do not accept or offer free samples, with the possible exception of situations of social or financial need, such as when a child would not receive therapy otherwise. For those cases, the samples must constitute appropriate therapy and cover the duration of treatment.
• Fully disclose any relevant commercial ties with industry to committees for whom this relationship may constitute a real, potential or perceived conflict of interest.
• Organizers of continuing medical education may apply to industry for unrestricted educational grants for educational activities that contribute to the improvement of patient care. Support may include reasonable speaker expenses and modest meals for course participants if meals are incidental to the educational content of the meeting.
• Industry should not be involved in choosing speakers or content for continuing medical education presentations.
• Educational curriculum should be provided by training programs and medical institutions on the ethics of interacting with industry and potential impact on treatment bias, scientific objectivity and conflict of interest.

CONCLUSION

The role of the practitioner is to act in the best interest of the patient. In addition to ensuring due diligence in investigating the risks and benefits of available treatments and evaluating the evidence-based literature, the importance of maintaining the integrity of the practitioner–patient relationship is paramount. There is a need for complete transparency with respect to industry inducements and for educational programs to build a better understanding of the relationship between practitioners and industry. In the final analysis, our fiduciary relationship with patients and the trust that is essential to the patient–practitioner relationship are too important to jeopardize.

Acknowledgements

This practice point has been reviewed by the Fetus and Newborn, Infectious Diseases and Immunization, Annual Conference, and Continuing Professional Development Committees of the Canadian Paediatric Society.

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CPS BIOETHICS COMMITTEE

Members: Kevin Coughlin MD (past Chair), Dawn Davies MD (Chair), Julie Emberley MD, Marie-Claude Grégoire MD, Ian Mitchell MD, Aideen Moore MD, Paul Thiessen MD (Board Representative)

Principal authors: Susan Albersheim MD, Kevin Coughlin MD

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References

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Disclaimer: The recommendations in this position statement do not indicate an exclusive course of treatment or procedure to be followed. Variations, taking into account individual circumstances, may be appropriate. Internet addresses are current at time of publication.