Conflict of Interest Research Paper

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Abstract

Conﬂict of interest is a widely debated topic in medical practice, research, and education. This research paper analyzes the concept of conﬂict of interest and related theories in relation to clinical practice, biomedical research, medical education, the development of clinical practice standards, and the strategies to deal with conﬂict of interest.

Introduction

Conﬂict of interest is a set of circumstances that create risk as a tendency of professional judgment or actions unduly inﬂuenced by a secondary interest (IOM 2009; Thompson 1993). In medicine, primary interests include promoting and protecting the welfare of patients, the integrity of research, and the quality of medical education. Secondary interests include ﬁnancial interests (income, patent, stock, etc.) and nonﬁnancial interests (professional promotion, reputation, etc.) Conﬂict of interest is a set of circumstances instead of an action. Conﬂict of interest is different from conﬂict of obligation and conﬂict of commitment. A conﬂict of obligation arises when an individual or institution has duties that require different actions but only one of these actions can be taken in the given circumstance. Essentially, they are conﬂicts among different primary interests. Conﬂicts of commitment are conﬂicts between the employees’ primary responsibilities to the institution and their outside commitments (IOM 2009). Conﬂict of interest occurs at institutional level as well as individual level. Institutional conﬂict of interest (ICOI) is a set of circumstances which research, teaching, or service is compromised because of external ﬁnancial or business relationships held at the institution in the form of increased incomes (such as payments, donations) or when external ﬁnancial relationships tend to inﬂuence decision-making regarding these activities (Slaughter et al. 2009).

Conﬂict of interest occurs mainly in clinic practice, biomedical research, medical education, and the development of clinical practice standards.

Conflict Of Interest In Clinical Practice

The nature of physician–patient relationship is ﬁduciary. Fidelity to the patient is one of the physician’s fundamental obligations. The rules of ﬁdelity are often weakened by conﬂict of interest. In clinical practice, many factors might induce physicians to pay more attention to their personal gain than to the patients’ optimal care.

The Pharmaceutical Industry

Surveys show that physicians have frequent contact and close relationships with the pharmaceutical industry. They receive drug samples, meals, tickets to entertainment events, and free travel, among other beneﬁts (KFF 2002). In order to increase sales, promote products, and cultivate physicians’ preferences , medical representatives give rebates to doctors and medical institutions in China and other countries. These actions may affect prescriptions and undermine scientiﬁc and objective clinical decisions. Some physicians act as promotional speakers on behalf of drug companies.

Medical Institutions

Many hospitals and clinics set incentives to encourage doctors’ overtreatment behavior, depending on the institutions’ purpose and the needs of the patient. For example, many public hospitals in China set minimum proﬁt quota for each clinical unit. The incomes of physicians and nurses are closely related with the income of the clinical unit.

Third-Party Payers

Third-party payers have imposed many constraints on medical decisions about diagnostic and therapeutic procedures through mechanisms designed to control costs. For example, health maintenance organizations (HMOs) often withhold a substantial part of the primary physician’s income. At the end of the year, they return part or all, depending on the overall ﬁnancial condition of HMO and in some cases the physicians’ productivity and frugality. This arrangement creates an incentive for physicians to severely limit expensive procedures (Beauchamp and Childress 2013).

Conflict Of Interest In Medical Research

Since the 1980s, many countries have been attempting to promote the cooperation between industry and academia. In the USA, the Bayh–Dole Act (1980) was passed with the intent of accelerating technology transfer from universities to the private sector. In China, many universities started their own companies to proﬁt from government funding programs. Now industry relations with academic biomedical researchers are very extensive. According to a national survey in the USA, institutional academic–industry relationships are highly prevalent, and almost two-thirds (60 %) of department chairs in medical schools and large teaching hospitals had some form of personal relationship with the pharmaceutical industry, including serving as a consultant, a member of a scientiﬁc advisory board, a paid speaker, an ofﬁcer, a founder, or a member of the board of directors (Campbell et al. 2007). Collaborations between academia and industry promote the rapid translation of basic science research into applications. Many new medications and medical devices are produced based on the increasing collaboration between industry and biomedical research institutions. The investigators and their institutions also gain complicated ﬁnancial interests, such as gifts, stock and stock options, royalties, management positions, ﬁnder fees, and donations, among others. These kinds of private gains may unduly inﬂuence their professional judgments on the study design, recruitment of subjects, informed consent process, adverse event reporting, data analysis, and the publication of study results. Financial ties with industry may lead some investigators wittingly or unwittingly to tend to yield pro-industry conclusions. The companies investigate to keep information conﬁdential for more than 6 months or withhold data sharing. It may reduce the openness of communication and do harm to research freedom (Bekelman et al. 2003; Blumenthal 2003). Conﬂict of interest produces risks to the safety and welfare of patients and the reliability of research and may damage the public trust and conﬁdence of medicine.

Case Study

Conﬂict of interest is a widely debated topic in medical practice, research, and education. The case of Jesse Gelsinger is one such example. Gelsinger, an 18-year-old male who suffers from a mild form of ornithine transcarbamylase (OTC), controls his condition with a low-protein diet and meditation. In September 1999, Jesse voluntarily participated in an experiment at the University of Pennsylvania designed to test gene therapy as a treatment for OTC deﬁciency. The study was to ﬁnd treatments for babies with fatal forms of OTC deﬁciency. The treatment would not directly beneﬁt Jesse. On September 13, the research team from gene therapy research company Genovo injected adenovirus vectors carrying OTC genes into Jesse’s liver. Shortly afterwards, Jesse experienced severe reactions and died 4 days later. The Recombinant DNA Advisory Committee (RAC) conducted an investigation and found that Jesse was not a suitable candidate due to the condition of his health. The investigation further revealed that the consent process was incomplete and poorly documented and that the researchers did not disclose that the therapy had severe side effects when it was tested on animals; two monkeys died from a clotting disorder as a result of the experiment. Former participants suffered liver failure. Furthermore, conﬂicts of interests existed between the researchers and the institution. Notably, Dr James Wilson, the founder and project leader of Genovo, owned 30 % of the company’s shares. Genovo sponsored University of Pennsylvania’s Institute for Human Gene Therapy (IHGT) by issuing shares with a total value of 20 million dollars. Adenovirus was used in the gene therapy experiment in which Jesse participated. Dr Wilson, along with Dr William Kelley, a senior ofﬁcial at the University of Pennsylvania who authorized the implementation of the experiment, had a patent for the adenovirus vector technology and would receive ﬁnancial gains if the technology was implemented successfully. Moreover, the University of Pennsylvania would gain as a shareholder of Genovo. It was argued by Marshall (2000) that the economic considerations of researchers might have hindered them from picking the best candidates for the experiment, which further contributed to Jesse’s death.

Such cases occur in China, Italy, the UK, and other countries as well as the USA. In 2013, Chinese authorities announced that GSK gave £300 million in bribes to government ofﬁcials, doctors, hospitals, and others who prescribed their drugs in order to improve drug prices and promote sales. Several GSK executives were arrested as part of a 4-month investigation. In 2014, a Chinese court found the company guilty of bribery and imposed a ﬁne of £297 million. Mark Reilly and four other executives of GSK’s Chinese operations received a suspended prison sentence (Moore and Roland 2014).

Conflict Of Interest In Medical Education

In the recent decades, the pharmaceutical industry became increasingly involve in sponsoring medical education. A 2006 survey indicated that 65 % of clinical departments received industry support for continuing education, 37 % received industry support for residency or fellowship training, 17 % received industry support for research equipment, and 19 % received unrestricted funds from industry for department operations (Campbell et al. 2007). Many students and residents received food, books, drug samples, noneducational gifts (such as coffee mugs), workshops attendance, and social events organized by drug companies. The gifts may affect their prescribing behavior. Much information about accredited continuing medical education offered by companies is based on personal experiences instead of scientiﬁc data, and the speaker can tailor programs to secure company grants. As a result, many education programs are biased (Takhar et al. 2007).

Conflict Of Interest In The Development Of Clinical Practice Guidelines

Clinical guidelines are the key connection of medical practice, research, and education. They build on research, serve an educational function, and may inﬂuence patient and physician decisions in clinical practice. Ideally, clinical guidelines should be based on valid scientiﬁc evidence, critical assessment of that evidence, and objective clinical judgment that relates the evidence to the needs of practitioners and patients. However ﬁnancial relationships with industry may create conﬂicts of interest in the development of clinical practice guidelines (IOM 2009). A cross-sectional study shows that the prevalence of conﬂict of interest is high among members of clinical practice guidelines in Canada and the USA (Neuman et al. 2011). Relationships with industry and conﬂicts of interests may unduly inﬂuence each step of the guideline development process, such as selection of topics, review of evidence, expert panel deliberations, and the guideline dissemination (IOM 2009).

Policies And Regulations

Dealing with conﬂicts of interest is a complicated issue which requires cooperation among physicians, researchers, institutions, medical associations, as well as governmental agencies. In order to maintain integrity of professional judgments and societal conﬁdence in medicine, many laws, regulations, guidelines, and policies have been made by the FDA, NIH, AAU, AAMC, academic journals, and medical colleges. Among them, the three common strategies to deal with conﬂicts of interest are disclosure, management, and prohibition. To resolve conﬂicts of interest, the AAU made recommendations as follows: all facts should be disclosed, the majority should be managed, and certain procedures should be banned when necessary for the safety of the participants and to maintain objectivity (AAU 2001).

Disclosure

Disclosure is the ﬁrst step toward resolving the issue of conﬂicts of interest. Researchers’ timely disclosure of associated economic interests would protect the reputation of researchers as well as the institution. Public disclosure does not necessarily prevent the researchers from receiving economic beneﬁts, but people would give more objective estimates of the effects of economic considerations on the decision-making process. Two groups of people ought to timely receive detailed disclosure information: the ﬁrst group consists of research colleagues, research participants, journal readers, students, and patients, and the second group consists of institutions that are experienced at dealing with the issue, such as Conﬂict of Interest Committee (COIC) and IRB. Though disclosure is a necessary step for identifying and avoiding or managing conﬂicts of interest, it is not sufﬁcient because disclosure alone does not resolve conﬂict of interests or prevent the harms that may result from a conﬂict (IOM 2009).

Management

Academic institutions need to establish a standing committee (such as COIC, IRB) to review the conﬂict of interest disclosures of the physicians, researchers, and related administrators. They would determine to make management plans and take corresponding measures to prevent negative effects on the individual and institutional professional judgments during health care, research, and education. Sometimes, institutions may seek evaluation by or consultation with a third party or peer mechanism to screen a particular fact.

Prohibition Or Elimination

In some circumstances, the secondary interest relationships that threaten the primary interests are unacceptable and beyond control. In these cases, the individual or institution may end the relationship or quit the participation in certain activities.

Conclusion

Conﬂict of interest is prevalent in medical practice, research, education, and practice guidelines development. It may compromise the physicians’ loyalty to their patients and professional judgments and the integrity of research and damage public trust to medicine. Conﬂict of interest is affected by different sources, such as how physicians are paid and the ﬁnancial ties between physicians and the third parties (Rodwin 2011). Different countries may create various policies and regulations to deal with conﬂict of interest under different political and economic systems.

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