Re‐envisioning Our Approach to Research in Academia

Like every profession, scientists have always faced nonfinancial pressures that could bias the interpretation of their results: the need to compete for extramural grants, the desire to climb the academic ladder, and the desire to receive accolades from peers and to win prestigious research awards. ¹ However, there was little oversight as there was an incredibly high level of trust in the integrity of scientific discovery and a reliance on the ethical attitudes of individual investigators. ² In 1980, the playing field changed with the passage of the Bayh‐Dole Act. ³ This act not only provided the opportunity for academic investigators who were funded by federal grants and their institutions to commercialize their discoveries but actually encouraged them to do so. Scientists had both an academic and an entrepreneurial interest in their work, and relationships between academicians and industry blossomed. ⁴ American medical colleges (AMCs) also profited as they developed technology transfer offices to oversee the patenting of discoveries and the out‐licensing of patents to existing pharmaceutical or device companies, start‐up companies founded by university investigators, or the universities themselves.

Over the past decade, scandals in biomedical research at major AMCs have made the front pages of newspapers across the United States, leading the public to question whether physicians and scientists who populate Americas academic centers have “conflicts of interest” that cause them to make decisions regarding patient care or the presentation of research studies that are biased by their own personal financial interest. These highly publicized cases were not isolated events, as studies showed a strong association between a positive outcome and the presence of a conflict of interest among the authors of clinical studies. ⁵ Studies also showed that authors who had financial relationships with pharmaceutical companies were significantly more likely to reach supportive conclusions. ⁶ In 2000, only 47% of high‐impact journals had policies requiring disclosure of conflicts of interest. ⁷ Among journals that had conflict‐of‐interest policies, few articles actually included conflict‐of‐interest disclosures. ⁸ , ⁹ In addition, in a survey of 100 institutions with the most funding from the National Institutes of Health in 2000, only 55% required their faculty to disclose conflicts of interest. ¹⁰

Responding to the public outcries, prestigious journals instituted new policies for authors, and AMCs undertook efforts to mitigate the problem. Unfortunately, these efforts appear to have been only partially successful. A research team from Duke University Medical Center in Durham, North Carolina; Wake Forest University in Winston‐Salem, North Carolina; and Johns Hopkins University in Baltimore, Maryland, reported that only 48% of U.S. AMCs had a formal policy requiring that financial conflicts of interest be disclosed to participants in industry‐sponsored clinical trials. ¹¹ Even when conflicts of interest did exist, participants in clinical studies were informed about the conflicts less than half of the time ¹² and there was little agreement among institutions about whether disclosures should include the amount of a particular financial interest held by an investigator. ¹³ Thus, almost a decade after the first public disclosures of conflicts of interest in clinical trials, the problem has not been solved.

Issues regarding conflicts of interest also have surfaced in the context of published articles and, in particular, practice guidelines. For example, the publication in July 2004 of the National Cholesterol Education Programs (NCEP) that recommended the use of statins ¹⁴ was tarnished by the subsequent disclosure in the Los Angeles Times that one of the authors of the NCEP update had received $114,000 in consulting fees from pharmaceutical companies that produced the drugs. ¹⁵ In Minnesota, requirements for public disclosure of industry payments brought additional conflicts to light. Indeed, 87% of guideline authors had some form of interaction with the pharmaceutical industry, and 58% of authors had relationships with companies whose drugs were recommended by the guidelines they authored.

Responding to concerns on the part of the public, state legislatures have taken action. In 1993, Minnesota mandated that all pharmaceutical and device companies needed to report relationships with physicians—a mandate that was later passed in Vermont, Maine, West Virginia, California, and the District of Columbia. ¹⁶ More recently, Senators Charles Grassley (R‐IA) and Herb Kohl (D‐WI) introduced the Physician Payments Sunshine Act, a bill that would require manufacturers of pharmaceutical and medical devices to disclose the amount of money they give to individual physicians. In many respects, this bill would be beneficial for patients, physicians, and the pharmaceutical and device companies. However, in some states, governmental actions have simply gone too far. Recent proposals by the Massachusetts Senate would ban all gifts and freebies to doctors from pharmaceutical companies, a move that would make Massachusetts the first state in the country to ban such gifts outright. ¹⁷ Failure to adhere to the ruling could result in a fine up to $5,000 and jail sentences up to 2 years for practicing physicians who accept a pen, a pad of paper, or a slice of pizza from a company representative.

The proposed Massachusetts ban has been criticized for negatively impacting information flow to practitioners. ¹⁷ Academic leaders have also noted that, “the language of the legislature's proposed anti‐gifting bill is both severe and vague, inviting inquisitors and individuals with personal grievances to harass physicians involved in a large variety of potentially constructive research and educational activities. Such harassment will inevitably inhibit appropriate industry support of these legitimate activities.” ¹⁸ Thus, it becomes imperative that AMCs, professional associations, and scholarly journals regulate these conflict of interest issues in a manner that is fair, rational, and just, and that does not obviate the ability of academic investigators to collaborate with industry.

Academic‐industry relationships are of particular importance in translational research, where the goal is to rapidly translate discoveries in the basic science laboratory to the clinical arena. As Dennis Ausiello, MD, chair of medicine at Massachusetts General Hospital and a professor at Harvard Medical School, both in Boston, noted: “The notion that academic researchers who partner with industry are intrinsically tainted reflects a misunderstanding of the importance and quality of industry research, and the role industry plays in bringing new drugs to the patients who need them. While most of the original insights leading to new drugs and devices likely derive, at least in part, from the work of academic scientists, turning these preliminary advances into FDA [Food and Drug Administration]‐approved treatments required an exceptional investment by industry and vital partnerships between academic investigators and company scientists.” ¹⁹

As a journal that reports clinical and translational science—much of which involves collaborative activities between the biotechnology industry and AMCs—we believe that it is particularly important to insure that original research articles, commentary, and review articles are not biased by conflicts of interest on the part of the authors, and that the journal's readers can have full confidence in the data or opinions that are presented. However, at the same time it is our mission to publish timely information on recent advances from both academia and industry. How to deal with this conundrum has challenged all journals. In order to optimize our ability to present information in a timely manner while at the same time insuring our readers the information is presented in an unbiased fashion, we have followed the lead of other journals in presenting the reader with a full disclosure of “significant” conflicts of interest while recognizing that not all financial associations are the same. Our definition of a significant financial interest is consistent with that of the New England Journal of Medicine, in which the upper limit on the annual sum that a person may receive before a relationship is considered significant is $10,000. ²⁰ In addition, any equity in a publicly traded or privately held company in which the opportunities for profits are not limited also will be considered by the editors as being significant. Research support of any kind that exceeds $ 10,000 per year is also considered a potentially significant conflict of interest and must be declared. Finally, consistent with the recent guidelines from the Association of American Medical Colleges, our journal will not publish any articles—either review articles or original publications—that are “ghost‐written.”

We believe that the policies we have established for disclosing potential conflicts of interest will prevent financial interests from influencing the editorial content of CTS while at the same time recognizing that collaboration between academia and industry is a sine quo non of the clinical and translational sciences. In addition, our readers and contributors should recognize that our policies are not etched in stone but are guideposts that may require revision over time or flexibility under different circumstances. We as editors will carry the responsibility for weighing the available evidence and for making decisions that we believe will be in the best interest of scientific integrity and the dissemination of important and relevant new discoveries.