Ethics, gastroenterologists, and pharmaceutical and equipment companies

Much has been written about the relationship between medical practitioners and companies that promote pharmaceutical products or various medical devices. On one hand, some have argued that few, if any, interactions are appropriate as the major responsibility of pharmaceutical companies is to maximize profits for shareholders, while the major responsibility for medical practitioners is to provide the best possible care for patients. ¹ In contrast, others have conceded that medical practitioners and various companies do have the shared goal of improving human health and that the introduction of new products is normally preceded by clinical trials supervised by clinicians. ² Furthermore, we do need new and improved products to treat human disease, and the reality is that most of these will need development and promotion by larger companies.

The pharmaceutical industry has global sales in excess of US$1000 billion. ³ For many companies, expenditure on the promotion of medicines to health‐care professionals is significantly higher than expenditure on research and development. Presumably, the industry has determined that promotional activity is an important driver of product sales. The degree of interaction between individual physicians and the pharmaceutical industry is likely to be highly variable, but possible areas of contact are listed in Table 1. Most of us underestimate the contribution of industry to our activities, particularly in the area of sponsorship of major and minor meetings. For example, funds provided by industry often permit substantial discounts on the true cost of registration fees charged to participants. In relation to detailing, the evidence suggests that the majority of physicians agree to see industry representatives on a “one‐to‐one” basis. ⁴

Table 1.

Common areas of contact between gastroenterologists and pharmaceutical/equipment companies

Exhibits at national/international meetings.

Sponsorship of national/international meetings.

Sponsored symposia at national/international meetings.

Sponsorship of state/local meetings.

Sponsorship of departmental meetings.

Discussions with individual gastroenterologists (detailing).

Participation in clinical trials sponsored by industry.

Advertisements in professional journals.

Several publications have documented inappropriate or unethical behavior, not only by pharmaceutical companies but also by medical organizations and individual medical practitioners. ⁵ , ⁶ , ⁷ Although many of us feel competent to assess and compare new products, the evidence is that our preference can be influenced by promotional activity, particularly sponsorship of local meetings, individual visits by company representatives, free drug samples, and small gifts, often of an advertising nature. In some settings, this may result in a prescription for a drug that is inferior to or more expensive than an alternative product. However, before we castigate pharmaceutical companies, we need to remember that advertising and promotion are perfectly legal, providing that the information is scientifically accurate and fair and is presented in an appropriate fashion. In many countries (but not in the United States or New Zealand), direct‐to‐consumer advertising using newspapers, television, or social media is restricted to nonprescription or “over‐the‐counter” medication. ³

In this issue of JGH Open, Dr Gangireddy and others have analyzed industry payments to gastroenterologists and hepatologists in 2017 from data available on the Open Payments website of the Centers for Medicare and Medicaid Services (CMS) in the United States. ⁸ Legislation requiring pharmaceutical companies to publicly disclose all payments to physicians above $10 was passed in 2010, and data have been available online since 2014. Although the data are of interest, the results have focused on financial interactions between physicians and industry rather than the identification of potential conflicts of interest. For example, in the study by Gangireddy et al., a small number of individuals received payments of >US$100 000, but this could be related to fees for clinical trials, consulting fees, or payment to “key opinion leaders” for articles or presentations sponsored by industry. Authors from the CMS also concede that there are challenges in the collection and reporting of data that may have an impact on the integrity and consistency of website information. ⁹ An additional issue is that companies can delay the reporting of research‐related payments for up to 4 years or until the product has been approved by the Food and Drug Administration, whichever comes first.

Apart from the United States, many other countries have enacted legislation to require the disclosure of payments from pharmaceutical companies to medical practitioners and medical organizations. ³ , ¹⁰ Voluntary self‐regulation by industry has also been important with regulatory codes of ethics from industry organizations, as well as codes of ethics from individual companies. The latter has sometimes included public disclosure of funding to individuals or organizations on company websites. Some academic institutions such as Stamford also have regulations that influence the relationship between staff and pharmaceutical companies. These and other regulatory activities have resulted in a substantial reduction in interactions seen to be unethical or potentially unethical.

In practice, how should gastroenterologists and hepatologists respond to ethical issues raised by interactions with pharmaceutical or equipment companies? ¹¹ , ¹² Again, many medical organizations have detailed guidelines on their websites, although the frequency of “hits” remains unclear. Both industry and medical organizations agree that larger personal gifts, tickets to sporting and entertainment events, and travel for partners of physicians are inappropriate. Differences exist in guidelines for small gifts such as pens and office equipment, with some recommending rejection of all gifts in order to avoid bias in pharmacological management. There is also variation in guidelines regarding industry support for attendees at conferences that involve travel, accommodation, and registration fees. Some codes exclude travel support for physicians unless they are members of “faculty” and recommend that recipients of sponsored awards be selected and paid by independent conference organizers. Another issue is industry sponsorship of continuing medical education, not only at national and international conferences but also at local and departmental meetings. While several guidelines permit the provision of food and beverages, programming should be independent of industry in order to provide objective and balanced information for participants. Despite laws, industry codes, self‐regulation by industry, and guidelines by medical organizations, gastroenterologists and hepatologists will continue to encounter circumstances that involve ethics and conflicts of interest. Important progress has been made, but we need to be vigilant in avoiding impropriety and the appearance of impropriety while, at the same time, interacting with industry in ways that are both respectful and professional.