In an era of tightened government purse-strings, corporations play a central, if not controversial, role in funding research at Duke.
Duke has received the most corporate research dollars out of all universities nationwide for the last 10 years—$215 million in 2011. The next highest recipient, Massachusetts Institute of Technology, received just $110 million in 2011. As the University research budget soared from $441 million in 2002 to nearly $1 billion in 2011, for-profit firms have kept pace, financing approximately 22 percent of Duke’s research annually over that period.
The increase in corporate research dollars raises questions about possible conflicts of interest influencing the scientific process. Duke responded with a structure of safeguards to protect the legitimacy of its research.
The major factor behind Duke’s dominance in corporate-funded research is the Duke Clinical Research Institute, the largest academic research institute in the world.
DCRI was among the first “contract research organizations” to focus on corporate clinical trials. Now, at least 75 percent of the University’s corporate-funded research takes the form of clinical trials within DCRI, said Vice Provost for Research James Siedow. Only $7.5 million of the total $215 million in corporate-funded research go to projects outside of the Medical Center. With federal funding of University research stagnant in the last three years, Siedow has a mixed but more favorable view of the upward trend of industry research dollars spent.
“It is a large and, hopefully, growing part of the budget, but I can’t see commercial [funding] picking up federal research slack,” he said.
Reviews have unearthed controversial ground when assessing the integrity of this breed of research.
A 2010 review by a German medical journal found that industry-funded clinical trials are favorable to the new drug treatments far more often than studies funded by other sources. The Journal of the American Medical Association now mandates that researchers unaffiliated with the corporate sponsor to corroborate the results.
In November, the State University of New York Buffalo closed a research institute devoted to studying hydraulic fracturing—also known as fracking—after watchdog groups condemned a study incorrectly claiming a significant decline in fracking-related pollution. That same year, the institute started a multi-million dollar fundraising campaign aimed at gaining donations from large oil and gas firms.
Duke is not immune to conflict of interest and potential bias. Dr. Victor Tapson, a pulmonologist, was investigated in 2011 after he recommended the FDA delay approval of a generic counterpart to a blood thinner developed by drug giant Sanofi-Aventis. A Senate report claimed that Tapson did not properly disclose his financial ties—more than $250,000 in consulting fees— to the company.
Dr. Ross McKinney, chair of the Conflict of Interest Committee and professor of pediatrics, said a high proportion of corporate research presents several risks, including bias, loss of credibility and for-profit research crowding out less lucrative research.
“I most worry about the introduction of bias… particularly if it’s evident they want a specific outcome or [when it is] done to ultimately obtain corporate funding,” he said.
McKinney noted, however, that effective structures are in place to mitigate this risk. Researchers in the School of Medicine must formally disclose outside firms in which they have a significant financial interest. Employees with a significant relationship—at least $25,000—are restricted from being principal investigators for the research in question. If McKinney’s committee deems it necessary, these researchers are also restricted from the analysis and documentation of the research.
McKinney mentioned one recent case in which a faculty member was dishonest in his conflict-of-interest disclosure but declined to name the individual. The committee then severely restricted his faculty and research investigator privileges. But McKinney noted that there have been “surprisingly few” cases of faculty dishonesty, assisted in part by the committee’s diligence in combing research sources, like investigative news outfit ProPublica, for conflicts-of-interest.
Siedow noted that Big Pharma now prefers Duke as an unbiased third party. It is easier to deal with a failed but scientifically rigorous trial than a fudged trial, leading to later legal trouble.
Siedow said it would be foolish to distrust corporate executives while embracing government or nonprofit officials. Research funded by a competitive federal grant will likely face similar threat of bias as research financed by a corporate contract, he added. The main difference between the two funding sources occurs when an corporate-funded researcher has a personal monetary interest in a study’s results—a situation Siedow argued is accounted for by the conflict-of-interest reviews.
“The risk doesn’t lie with more corporate research—the risk lies with reducing NSF or other national funding,” Siedow said. “We won’t be leading the race for tomorrow’s nylon, tomorrow’s computer. Our brains won’t go dead from corporate research, but the nation itself might get hurt by its national priorities.”