Should the drug industry work with key opinion leaders? No

Abstract

Industry commonly works with experts to put across its message. Charlie Buckwell (doi: 10.1136/bmj.39541.702870.59) believes that such interaction is essential for medical advancement, but Giovanni Fava argues that it risks scientific integrity

The proliferating connections between doctors and the drug industry have brought the credibility of clinical medicine to an unprecedented crisis. Corporate actions that have placed profit over public health have become regular news. High profile examples include the misrepresentation of research on rofecoxib and on the use of selective serotonin reuptake inhibitors in children. Recently, two respected scientists who work for a drug company wrote that the problem of conflict of interest “could well erode the credibility of the entire enterprise of academic medicine, if not properly and promptly addressed.”^{1 2}

Industry objectives

The game is clear: to get as close as possible to universal prescribing of a drug by manipulating evidence and withholding data. A recent paper illustrates how selective publication of trials of antidepressants exaggerated their efficacy.³ Thirty seven of the 38 studies that had positive outcomes were published in peer reviewed journals compared with only three of the 36 studies with negative results.³ Industry tactics take the form of commercially strategic clinical trials (which have been defined as “experimercials”⁴), journal publications that are actually “infomercials,”⁴ and continuing medical education activities and scientific meetings whose main aim is to sell the participant to the sponsor.⁵

Who are the winners of the game? The drug companies and, apparently, the key opinion leaders who are hired for performing their parts. These experts get not only money and visibility⁶ but power, particularly if they become members of special interest groups.⁵ Because of the resultant contacts, members of these groups often get leading roles in editing medical journals, advise non-profit research organisations, and act as reviewers and consultants, enabling them to prevent dissemination of data that may be in conflict with their special (corporate driven) interests. The most prominent way they display their power is through meetings and industry sponsored symposiums. By carefully selecting the literature presented, key opinion leaders help the drug industry take control of scientific societies, clinical practice guidelines, and reporting of investigations.^{5 7}

Managing the problem

Patients and society at large are harmed by these practices as a result of irrational prescribing, omission of safety issues (such as with rofecoxib), and increased costs. But doctors are also affected because when trust goes so does the healing power of doctors.⁸ And, ultimately, the drug industry risks losing as well.^{1 2}

So what can we do? The problem of conflict of interest has been viewed mainly in negative terms: how to limit corporate influence in medical research. Little attention has been given to the fact that the scientific community is draining itself of a reservoir of truly independent experts who can advise government policy makers.⁹

Truly independent investigators are still available¹⁰ but they need support.⁵ This could include giving them priority for obtaining grants from public agencies, key positions in scientific societies, editorship of journals, and producing clinical guidelines. Despite journal policies, disclosure of conflict of interest is rare and at times meaningless.⁵ Conflict-free investigations and reviews should be emphasised in medical education, have priority in medical journals, and be clearly identified as such.

A crucial problem lies in the lack of a definition of substantial conflict of interest. If we assert that eating a pizza at a drug sponsored lunch and being a regular consultant to a firm carry the same weight, we have the perfect excuse for doing nothing. However, criteria can be agreed for establishing substantial conflict of interest. My suggestions include being an employee of a private firm, being a regular consultant to or on the board of directors of a firm, being a stockholder of a firm related to the field of research, and owning a patent directly related to the published work.⁵ These criteria, which are based on the work by Krimsky and colleagues,⁹ all imply a long term relationship with a private firm. Occasional consultancies, grants for performing investigations, or receiving honoraria or refunds on specific occasions would not constitute a substantial conflict. Indeed, it is perfectly legitimate for academic physicians to collaborate with the industry on scientific projects. Collaboration should not be extended, however, to business disguised as science (such as signing ghostwritten journal articles or speaking at promotional symposiums) and should be subject to universally agreed rules.⁵

The drug industry may recruit doctors for marketing its products. But we can no longer accept these doctors as key experts. Taxpayers and members of professional societies deserve scientific leaderships by researchers who have no substantial conflict of interest and are defending our intellectual freedom. And to all experts acting as the marketing arm of the drug industry we should convey a clear message: your time is up. We can no longer afford it.