A company producing drugs for the management of common conditions including asthma and diabetes has offered to pay the salary of a nurse in a doctor’s practice. The nurse’s role is to audit patients’ records, ensuring that those with conditions such as asthma and diabetes are regularly examined and receive up-to-date medication. The doctor thinks this enhances patient care. The nurse provides anonymized patient data to the company and is barred from promoting its products. Information about the company’s drugs is regularly provided by a sales team who visit the practice and pay for working lunches with the doctor. A good relationship exists and the company provides occasional gifts and invites the doctor’s staff to dinner.
A well-referenced and user-friendly handbook on the medical care of a range of allergies in babies and children has been issued without charge to medical students and practicing doctors. Distribution has been funded by a leading charity whose remit is to raise awareness in society and the profession about childhood allergies. Prescribing advice is included in the handbook and two specific anti-allergy drugs are recommended. They are described as being particularly suitable for babies and young children. Various companies market variations of the same products but the brands named in the free book are glowingly described as effective even in difficult childhood cases. Parents who have also seen the book are starting to request them by name for their children’s allergies. Both named brands are produced by the same pharmaceutical company. Student leaders have contacted local doctors and university colleagues urging them to lobby for the book to be withdrawn and to avoid prescribing these products. This is because the pharmaceutical company that produces the two named drugs previously donated $50 000 to the allergy charity that is distributing it. It is not obvious that the donation was specifically for this handbook, however, and many students are reluctant to reject a free learning tool, arguing that they are sensible enough not to be unduly influenced by the prescribing advice (Jack, 2006).
A conflict of interest has been described as “a set of conditions in which professional judgment concerning a primary interest tends to be unduly influenced by a secondary interest” (Thompson, 1993). Medical research is notorious for giving rise to significant conflicts of interest and these are discussed in Ch. 30. Here the focus is on the influence exercised by the pharmaceutical industry’s promotional activities on medical education and patient care, which is also highly controversial. Sixteen compromising but common ways have been identified in which health professionals become entangled with drug companies (Moynihan, 2003). More potentially arise as the industry seeks new marketing methods. Such measures include the provision of hospitality or gifts for prescribers, company funding for clinical audit or research, paid meetings with company representatives, sponsored travel to conferences in exotic locations, inordinately high fees for conference speakers, and publishing opportunities for industry-friendly reports. Some of these activities are acceptable but only if on a modest level and open to scrutiny. Some are unacceptably compromising but seen by those involved as merely “the entwinement of individuals from different backgrounds and value sets who get to know each other and therefore want to reciprocate friendships and favours” (Smith, 2003). The result is that boundaries are blurred. As evidence mounts that prescribing patterns are seriously affected by such marketing strategies, prescribers often seem unwilling to acknowledge the excessive influence of venal interests (gifts and hospitality), clever advertising, or the apparently reassuring company information sheets.
Conflicts of interest occur in medical education in several ways. Educational meetings may be subsidized or feature sponsored speakers who only provide a pro-industry picture. Participants’ travel or lavish accommodation may be subsidized so that they feel well disposed towards the sponsor. Educational materials or journal articles may be provided by a sponsoring company to reflect its views. More subtle influence may be exercised by the sponsor’s views being incorporated into educational material published by an apparently independent third party. The media spotlight is increasingly turning, for example, on to the way in which charitable donations by drug manufacturers to patient support groups can result in an indirect but still very powerful influence on prescribing patterns (Jack, 2006). As a proportion of the overall funding of postgraduate medical education, the sums spent by pharmaceutical and biomedical companies frequently rival that of independent funders, including governments. The industry also exerts an enormous influence on practitioners’ prescribing and treatment patterns, not least because its drug information is often more readily available and more reassuringly worded than other sources of prescribing advice. Drug advertising often associates brands with attributes designed to appeal to prescribers, particularly inexperienced ones. Despite reams of analysis about how such conflicts can be minimized or avoided, they appear undiminished. More crucial than ever, therefore, is the need for practicing health professionals and students to raise their awareness of them.
While there is nothing inherently unethical in the occurrence of conflicts of interest in medicine, there may well be in the manner in which they are addressed. Society expects particularly high standards of the caring professions, whose advice should be independent, evidence based, and motivated by altruistic concern for patient welfare. These same expectations apply to doctors working within the pharmaceutical industry, who may feel pressured by product loyalty or colleagues’ drive to maximize profits. Pharmaceutical and allied industries are well aware of the common public perception that they are disproportionately profit orientated and are increasingly try to address the range of ethical issues raised by their work (Mackie et al., 2006). For doctors working for pharmaceutical companies, the conflicts of interest can be acute, but their ethical obligations to be truthful, maintain professional integrity, and put patient safety first are no less than those of any other doctor. Public trust can be seriously undermined if self-regarding interests supersede in medicine, even though they may be endemic in other sectors of society. Public confidence is also compromised if it appears that prescribing and treatment decisions are influenced more by pharmaceutical promotional materials than objective evidence. Professional and regulatory bodies acknowledge that even the unfounded perception of undue influence can be as damaging to public trust as corrupt practice. A common emphasis found in the guidance is that prescribers must be wary when any pecuniary or other incentive is offered. They must be as alert to perceived conflicts of interest as well as to actual ones since patients’ erroneous belief that doctors’ judgement is skewed towards personal advantage undermines trust as much as real corruption.
Legal provisions vary in different jurisdiction. Nevertheless, there is a generally shared recognition that certain professionals, including doctors, are in a privileged position in the community in terms of the power and knowledge they acquire. The trust and societal status given to them requires them to avoid acting solely in their own interests when in a professional relationship with patients or clients. In some societies, this is covered by the concept of “fiduciary duties” obliging doctors to act conscientiously to maintain patient trust and public confidence. In jurisdictions that lack explicit reference to fiduciary duties, the same obligation is expressed in other terms. It is usually covered by the codes of professional bodies that may have the force of law. In the UK, for example, the General Medical Council is the regulatory body for medicine. Its powers are derived from the Medical Act 1983 and its guidance has binding force on doctors who are registered. The guidance reminds doctors of their legal and ethical obligation to act in patients’ best interests and warns them against accepting any inducement, gift, or hospitality that may either affect or be seen to affect their judgement (General Medical Council, 2001). In addition in many jurisdictions, pharmaceutical and biomedical industries are bound by a range of regulations that similarly require them to exercise social responsibility. Not only do these regulations govern the conduct of clinical trials, pharmacovigilance, and the reporting of adverse events but they also cover marketing and product promotion. For example, the advertising of drugs in the UK is controlled by a combination of statutory measures such as the Medicines Act 1969, with both criminal and civil sanctions, and the pharmaceutical industry’s own self-regulatory codes. Nevertheless, the law sometimes needs interpretation in the context of new scenarios, such as the situation described in the second case opening this chapter.
Public policy requires that patients be able to have confidence in healthcare services. The professional codes for both doctors and the pharmaceutical industry proscribe activities that might undermine patient or public trust. National pharmaceutical codes focusing on marketing activities are published, for example, by the Association of the British Pharmaceutical Industry (ABPI) in the UK, Medicines Australia and the Pharmaceutical Research and Manufacturers of America. Promotional activities are also covered in international guidance, such as those published by the International Federation of Pharmaceutical Manufacturers and Associations (2003), the European Federation of Pharmaceutical Industries and Associations (2006), and the World Health Organization (1988). What is less clear is how widely these are known and how rigorously enforced. In the UK, a survey of doctors (ABPI, 2006) found that few were aware of the rules governing pharmaceutical representatives’ relations with them and even fewer knew how to make a complaint under the pharmaceutical code. Yet the complaints procedure can be an effective tool in enforcing standards and drawing public attention to breaches by the industry.
The enormous influence of the pharmaceutical industry is an issue of concern in many countries. A growing literature has examined it in different contexts and eminent bioethicists have summarized it (Lemmens and Singer, 1998). Medical journals have produced thematic issues devoted to it (e.g., the British Medical Journal; Anon., 2003). In the UK, a Parliamentary committee (House of Commons Health Committee, 2005) investigated it, finding that the industry’s marketing affects all sectors of society – not only prescribers, but patients, regulators, managers, medical charities, researchers, academics, the media, and politicians. Pharmaceutical industry influence is particularly crucial for current and future prescribers of medicinal products and devices. The parliamentary report described how doctors become tainted by their association with industry and recommended measures to curb marketing excesses. This echoes concerns long expressed in other countries including the USA, Canada, and Australia. All have experienced calls for stricter control on the way that drugs are advertised, particularly to young health professionals.
In fact, since the 1980s, attention has been repeatedly drawn to the way in which medical education and prescribing are influenced by pharmaceutical companies, whose advertising also constitutes a large percentage of the revenue of many medical journals. In the UK, the problem was highlighted and guidelines published in the mid 1980s (Royal College of Physicians, 1986). As concern grew internationally, more guidance followed. In 1990, the American College of Physicians published Physicians and the Pharmaceutical Industry, followed in 1998 by guidance from the Canadian Medical Association and in 1999 by the Australian (Royal Australasian College of Physicians, 2005). Such guidelines expose common quandaries in the way in which industry influences the structure and function of medical education at all levels. Codes provide guidance on the handling of conflicts of interest that need to be addressed from both the perspective of health professionals and from that of the pharmaceutical industry. They forbid doctors from accepting – and companies from offering – significant gifts, including lavish travel, expensive hospitality, or extravagant meals. Any funding must be modest and open to scrutiny.
Detailed international guidance for medical practitioners working in the field of pharmaceutical medicine is also available. It recognizes that they experience an understandably strong interest in the drugs they have been involved in developing. They must recognize, in turn, their ethical responsibility to stand aside from product loyalty and other pressures stemming from their employment and ultimately put the protection of patients’ interests first. Just as prescribers must seek independently verified data, doctors employed in the pharmaceutical industry must seek to ensure that only reliable and accurate information is used in marketing. They have difficult conflicts of interest that demand considerable determination and doctors should be supported by their professional bodies when they make a stand.
Pharmaceutical representatives have been described as the “stealth bombers of medicine: they swoop in, change practice, better than any journal article or formal educator” (Shaughnessy and Slawson, 1996). Drug companies’ interaction with doctors and academia has also been compared to porcupine quills – numerous and harmful if approached the wrong way (Lewis et al., 2001). Scholarships, grants, or other educational funds are provided by biomedical industries. Over half of all UK postgraduate medical education and much nurse education are funded by the pharmaceutical industry from its marketing budget (House of Commons Health Committee, 2005). This is not unique to the UK but is representative of a general trend. The powerful effect of such influence on medical students was the focus of a Finnish study (Vainiomaki et al., 2004), which found that students’ reliance on pharmaceutical promotions as an educational source increased over the course of their studies. It does not disappear after graduation. Former New England Journal of Medicine editor Arnold Relman (2003) commented that practicing doctors “are taught about drugs by agents of the pharmaceutical industry, which works hard to persuade them to select the newest and most expensive medication – even in the absence of scientific evidence that they are any better than older, less costly ones.” Even when aware that marketing was likely to affect their later prescribing, the Finnish students did not favor reducing it. This may be because the importance of avoiding undue industry influence is insufficiently emphasized in medical ethics teaching in most countries. Even in the USA, where awareness of the power of pharmaceutical marketing is probably highest, only one in four medical schools provide courses to prepare students in this respect (Black, 2004).
The need to inculcate good prescribing habits in young doctors has been the focus of a considerable literature, and some student organizations have taken on the task of awareness raising. In 2002, the American Medical Student Association started its nationwide “PharmFree” campaign urging an end to sponsored education, free lunches, and pharmaceutical advertising aimed at students. It encourages members to seek out independent, evidence-based sources of healthcare information and rejects all pharmaceutical advertisements and sponsorship. Its website highlights how “the practice of pharmaceutical gifting to students and physicians increases the costs of health care for patients and does not primarily serve patient interests” (American Medical Student Association, 2006). The topic of relationships with industry has also been a major issue in Australian and Canadian student groups, among others.
Professional codes require prescribers to put the patient’s interest first, but prescribing patterns are often influenced by drug companies through the provision of gifts, dinners, funding, financial assistance with travel for prescribing doctors and nurses, or accommodation at scientific meetings. Inexpensive gifts, limited hospitality and travel sponsorship are acceptable, and clear criteria are set out by professional associations. Professional codes ban lavish gifts or inducements from pharmaceutical companies and prohibit company representatives from offering them.
Traditionally, doctors and medical students have been the main targets of pharmaceutical advertising, but nurse prescribers are increasingly approached. All health professionals suffer information overload, but they have a responsibility to inform themselves independently about the drugs they prescribe. Professional organizations must also strive to help doctors working in pharmaceutical companies to exercise rigorous control over the marketing information. The dangers of not doing so were highlighted by a Scottish investigation into a child’s death. Ten times the licensed dose of a common asthma drug had been prescribed, largely because of the reassurance provided by the manufacturer’s marketing material about its safety (National Patient Safety Agency, 2005). Advertising slogans stressing the drug’s benefits for children led doctors to prescribe high doses without checking evidence-based guidance.
A number of strategies for individual and collective action have been identified. The most basic duty is for all health professionals to be vigilant about the kinds of circumstance in which temptation occurs and to familiarize themselves with their professional bodies’ rules. Obviously, they need to be able to recognize the potential for conflicting interests, but this is not necessarily as easy as it sounds, as shown by the case examples at the start of the chapter.
Codes of practice must not only be taught and known but also enforced. Whereas the regulatory codes for medicine can result in doctors being banned from practice, one of the problems with pharmaceutical codes has generally been their voluntary nature and lack of enforceability. They are, however, backed up by a complaints procedure, which, in an increasingly image-conscious world, there seems to be growing willingness to implement and publicize. This means that people employed in healthcare and industry should understand how the relevant complaints procedures work.
Regrettably, the provisions of professional codes and evidence of the strong influence of marketing on prescribing appear to be poorly appreciated by many practitioners. Internationally, few courses exist to help students and doctors to evaluate marketing campaigns, but general issues around pharmaceutical promotion and its influence on prescribing must be highlighted in undergraduate education for all health professionals. Such training should also guide them about where to find reliable non-industry sources of prescribing guidance. Undergraduate and continuing professional training need to highlight independently validated sources of data and international evidence-based clinical publications. In countries such as the UK, where nurse prescribing is growing, the lack of specific courses for nurses makes them particularly reliant on pharmaceutical company promotional information. Training is a key issue, not only for health professionals but also for pharmaceutical company employees, who need to be aware of the acceptable boundaries of their interaction with clinicians.
Despite the repeatedly stated desire of health organizations and professional groups to distance prescribing from the influence of marketing, finding acceptable alternative funders for education has remained a problem. This needs to be further addressed nationally and internationally.
Openness and public disclosure are key factors in defusing many potential conflicts of interest. Speakers at conferences and authors of articles must declare any interest or links they have with industry when presenting their views. They should alert their audience to the possibilities of conscious or unconscious bias. The duty to disclose financial or professional interests is also recognized in the publishing rules of medical journals. Regulatory codes emphasize the importance of health professionals always declaring to patients or to institutional healthcare purchasers any personal or financial interests they (or close relatives) hold. Registers have been proposed in some countries for all health workers to record all gifts and benefits given to them over a trivial sum, including travel and hospitality. Even where such registers exist, according to evidence from the pharmaceutical industry itself, many health professionals remain unaware of the requirement to declare their interests (ABPI, 2005). Cases undoubtedly still occur in which doctors accept significant benefits or cost-free opportunities to attend symposia in exotic locations with pharmaceutical sponsorship. Such offers are likely to be seen by the public as thinly disguised bribes. Only inexpensive tokens or modest hospitality at meetings with clear educational content are likely to be above suspicion. In any case of doubt, reference should be made to the local professional guidance. Even if prescribers themselves are convinced their independence will not be compromised, the perception that the industry is buying influence needs be avoided. Therefore, rigorous attention is needed in any situation that could be perceived as compromising.
The cases have been chosen because they are common and represent the borderline between what is clearly prohibited and what is deemed ethically acceptable. In the first case, it is unwise of the doctor to accept gifts or expensive meals. The services of the audit nurse represent a significant gift and, although it not clearly prohibited, any strings attached to it need to be carefully reviewed. If accepted, it should be declared if a local public register exists. Although company-sponsored nurses do not promote drugs, the data they research are used by the company sales teams to assess the practice’s potential market. Nurses may also receive bonuses by identifying patients who could be transferred to costly new drug schemes and so pressure to transfer them builds up on the doctor. Any form of company-sponsored service must be handled with care and with a keen eye to the public’s and patients’ perceptions. Doctors’ awareness of their own and colleagues’ prescribing patterns needs to be high and in line with peer practice, with regular review if patterns change as a result of accepting the service.
The second case illustrates one of the subtle ways that medical education can be influenced when sponsored material is provided to medical students and practicing doctors as if it were completely independent, unbiased advice. Unfortunately, such material is often aimed at, and taken up by, the most inexperienced prescribers. In accepting such free books, students and doctors need to be aware that they are likely to be perceived as acting in a biased way if they subsequently prescribe the products recommended, unless they have clearly considered rival products. In the UK, regulators have forced the withdrawal of some sponsored information booklets for doctors (Jack, 2006). Similar educational materials to which patients have access and which mention specific drugs have also been ruled as violating the UK ban on advertising drugs directly to the public. While there is nothing unethical or illegal in companies donating to charities or patient groups or sponsoring their materials, all such donations must be open and transparent.