Insights: Research and Analysis

IN THIS ISSUE

Research Ethics: Is There a Race to the Bottom?

By Kevin Schulman, M.D.
Professor of Medicine
Director, Center for Clinical and Genetic Economics
Director, Health Sector Management Program at The Fuqua School of Business

At Duke, we have undertaken a series of important projects assessing research ethics in several arenas from publication of clinical trial results, to financial disclosure, to globalization of the clinical research process. In each of these areas, we have found that the best intentions of firms, academic institutions, and investigators are often not achieved in actual practice. Overall, this creates a unique aspect in healthcare markets where those with the highest standards of ethics may be at a competitive disadvantage in each step of the research process. Such a situation may force firms from their ethical standards and initiate a race to the bottom where standards for research ethics are below any desired level.

Academia clearly shares in the blame for the lapse of ethical standards. This is made clear in this paper by Kevin Weinfurt which adds another document to those uncovered by Senator Grassley's current investigation. Institutional cultures and policies over the last two decades have clearly contributed to the failure highlighted in Weinfurt’s paper.

We hope that by bringing these studies forward we can actually interrupt this process, and help create a level research ethics framework across all academic and commercial-clinical research efforts. In many cases, this means addressing festering, outdated frameworks and concepts, which inhibit enhancement of research ethics in the field. It may also require an examination of long-standing business practices, which have outgrown their usefulness on all sides.

At Fuqua, we can bring these issues to the classroom in our biotechnology, pharmaceutical, and medical device classes – from both a basic ethics perspective as well as from a commercial perspective. We hope to present this not as a soapbox issue, but as a basic business strategy issue across all sectors of the life science industry.

Your comments and perspectives would be greatly appreciated on how to further advance our work in this area, in the classroom and in our own research efforts.

Consistency of Financial Interest Disclosures in the Biomedical Literature: The Case of Coronary Stents

By Kevin Weinfurt
Associate Professor, Medical Psychology
Medical Research Psychologist at the Duke Clinical Research Institute

Today’s clinical research enterprise involves multiple financial relationships among researchers, research institutions, and commercial entities. These relationships have caused some concern among the public. For the past several years, my colleagues and I have been interested in evaluating strategies for managing financial conflicts of interest in clinical research. One of the most frequently suggested strategies is disclosure. Having spent several years studying the disclosure of financial relationships to potential research participants, we decided to learn more about how researchers’ financial relationships were being handled in published disclosures in medical literature. Incomplete or inconsistent disclosure of financial interests in medical literature could be damaging, because it might lead people to underestimate the extent and nature of financial relationships in clinical research.

Our intent was to study how consistently disclosures were made. For example, if an author published multiple articles on the same topic in the same year, were the financial disclosures in those articles consistent? However, the issue of consistency in disclosure was soon eclipsed by the lack of disclosure. Out of 746 articles on coronary stents published in 2006, 72% of research articles did not include information about the source of funding. A total of 83% of all articles did not have a financial disclosure statement for any author. (Note that statements indicating the authors had nothing to disclose were counted as disclosure statements.) In the rare instances when authors’ financial interests were disclosed, they were disclosed consistently in only 3% of cases.

These findings could reflect behaviors of both journals and authors. Journal policies regarding disclosure can vary in important ways, including whether and how authors are asked to disclose financial interests; whether the disclosures are always published or the editor determines which disclosures are necessary; and whether journals solicit and publish disclosures for different types of articles (e.g., research articles versus editorials).

Authors are responsible for part of the problem, as well. Authors might have different interpretations of journal requirements, especially those that ask authors to report “relevant” financial interests. There is good reason to believe that authors, like all of us, are often unaware of all of the determinants of their actions. It is also possible that some authors chose to conceal their financial relationships, though our study has no way of confirming this. Our own informal Internet search did reveal that some authors who explicitly declared they had no financial interests did in fact have relationships that many would consider to be conflicts of interest.

Our data highlights the need for greater uniformity and transparency in how financial relationships are disclosed in medical journals. However, a larger issue remains: How do different decision makers use financial disclosures in their own thinking about research articles? It is possible, for example, that widespread disclosure could lead to a public sentiment that all such relationships are normal and, therefore, acceptable. This prompts an important normative question: “How should decision makers use such disclosures?”
Read the complete paper >>

Full Disclosure is Needed

By Matthew Kirchner (’03)
Director of Marketing
Medtronic Inc., Medtronic Diabetes

As the cost of healthcare continues to rise, the need for manufacturers to demonstrate both clinical efficacy and cost effectiveness is critical to long-term viability. This cost versus efficacy tension is heightened by increasing public awareness and federal scrutiny of new product introductions in the pharmaceutical, biotechnology, and medical device industries. The need for unbiased clinical data and health economic data to support therapies is essential as the business of delivering healthcare evolves.  

To help address the changing landscape, companies often engage healthcare providers to conduct clinical trials, participate in advisory boards and provide consulting services regarding new and existing products. The manner in which these relationships are disclosed is important to building public and government trust in the science that supports these therapies. Based on the recent study by Kevin Weinfurt that analyzed the consistency and frequency of reporting financial interests of researchers, there appears to be significant discrepancies that should be addressed moving forward by each of the key stakeholders: manufacturers, healthcare providers and journal publications. The two cornerstones of improvement are consistency and full disclosure.

Consistency of reporting is the fundamental first step to ensuring that all parties involved in generating the data, marketing the products and making critical business decisions are provided the same set of information. With consistency across journals and among authors, all parties viewing the data would be more likely to trust the science and the impact of the data on patient health. 

Full disclosure of financial interests for both manufacturers and healthcare providers would provide the public and government better visibility into the working relationships that impact product development and marketing. The value of the information is only as good as what is disclosed. If relationships are only partially disclosed or key funding is not mentioned, the public is left wondering why the information was omitted. This doubt can undermine the power of the data and devalue the manufacturer’s investment.

Practically speaking, full and consistent disclosure of financial relationships is not an easy fix. Most manufacturers are involved with numerous physicians and a majority of patients would not research this type of information when reviewing clinical data. So why should manufacturers, journals, and healthcare providers attempt to provide full consistent disclosure to the public? Continuing to build trust in the process that develops and delivers technology that changes patient lives is critical to keep innovation moving, so we can impact more even more lives.