Has the hunt for conflicts of interest gone too far? No

Abstract

Thomas Stossel argues that restrictions on doctors’ and academics’ interaction with commercial companies are damaging research, but Kirby Lee believes it is a price worth paying to maintain public trust

Conflicts of interest occur in health care when clinicians or researchers have personal, professional, or financial interests that could interfere with, or be perceived to interfere with, their professional obligation to act in the best interests of patients or objectively conduct, present, review, or publish research. Although the existence of a conflict does not necessarily mean wrong doing or harm, it does require management to prevent potential bias, or the perception of bias, in medical decision making or research.

Recent attention has focused on conflicts of interest between healthcare professionals and the drug industry. Marketing expenditures for drugs in 2004 was estimated at $57.5bn, nearly twice that spent on research and development.¹ Drug and medical device companies have been convicted of criminal violations or have settled civil suits for offering clinicians millions of dollars in kickbacks, bribes, or gifts to get them to use their products. The most notable case illustrating how direct marketing to doctors can lead to serious harm was the rofecoxib scandal. According to internal company documents, Merck developed an aggressive marketing campaign to “neutralise” or win over influential doctors known as key opinion leaders by showering them with gifts, grants, and donations and trained its sales representatives to “dodge” questions about the cardiovascular risks of rofecoxib.² Illegal marketing activities that overstate a drug’s benefit, downplay its risks, or promote it for off-label use have occurred throughout the industry.

Harm of conflict

Evidence is growing to demonstrate the negative consequences of certain marketing practices and other interactions with industry on clinician behaviour. For example, clinicians with ties to industry are more likely to prescribe the company’s brand name product rather than cheaper generic drugs when there is no therapeutic advantage,³ more likely to request the company’s drug is added to formularies,⁴ and more likely to prescribe company drugs for off-label use,⁵ all of which could lead to unnecessary healthcare costs and harm. Such influence is a serious concern because nearly all doctors have some type of relationship with industry, whether this is receiving food or drug samples, payments for consulting, enrolling patients in trials, or participation in marketing activities.^{6 7}

Most doctors believe that they are immune to influence from industry but that their colleagues are not.^{8 9} Yet research in social science shows that gifts of any size from drug companies create feelings of obligation and reciprocity.^{10 11}

Similar problems have occurred in the conduct and reporting of research, particularly suppression of negative results or failing to disclose harmful side effects as in the cases of rofecoxib and paroxetine.^{12 13} In the United States, the death of 18 year old Jesse Gelsinger in a gene transfer trial at the University of Pennsylvania drew widespread public and federal scrutiny of financial conflicts of interest in research. The researchers and the university owned equity in the company developing the gene therapy technology used in the trial. An FDA investigation found serious deficiencies in the conduct of the trial including failure to immediately report serious side effects in two previous patients and doubts about whether Gelsinger was fit to participate. Failure of the university and individual researchers to manage the conflicts subsequently led to lawsuits, negative publicity, and regulatory action, including suspension of all human gene therapy research at the university, which had one of the largest academic gene therapy programmes in the country.¹⁴ The tragic results of this trial shocked the public, were a major setback to gene therapy research, and show the seriousness of managing financial conflicts of interest in research.

Current policy is failing

Clearly, the drug and medical device industry has made large contributions to improving public health through beneficial relationships with clinicians and researchers on product development. However, it is also clear that there are some individual clinicians, researchers, and industry employees who serve their own interests at the expense of patients as evidenced by the recent law suits, complaints, and tragic events. Such individuals are few and far between, but no price is too high to prevent human suffering or erosion of trust from failing to identify and manage conflicts of interest.

Healthcare professionals and the drug industry have tried to manage conflicts of interest with greater self regulation and reform. Despite guidelines for appropriate relationships and gift giving between industry and healthcare professionals,^{15 16} problematic conflicts continue to arise. This may be due to the wide variation in defining what constitutes a conflict and how it should be managed¹⁷ or, perhaps, the lure of profits is too great. For example, disclosure is often voluntary and subject to interpretation, resulting in undisclosed or insufficient explanations of potential conflicts.

The hunt for conflicts of interest must therefore go on. The US has recently proposed a law mandating state disclosure of payments to clinicians by drug companies,¹⁸ and there are proposals to ban all gifts to clinicians and prohibit healthcare professionals who have financial ties with drug companies from making certain medical decisions (such as, drug formularies, clinical practice guidelines) and publishing articles that have been ghostwritten by industry.¹⁹ Such requirements may frustrate clinicians and researchers but, in doing so, will help to ensure the safety and welfare of the public, uphold scientific integrity, and preserve trust. Trust and credibility, once damaged, are difficult to restore. And when you become the patient, wouldn’t you want to be assured that medical decisions are made in your best interest?