Research

Under Fire, National Academies Toughen Conflict-of-Interest Policies

April 25, 2017

AAAS
Marcia McNutt, president of the National Academy of Sciences, plans to discuss potential financial conflicts of interest in an address next week at the academy's annual meeting. Another official says the idea of a policy review on this issue "has just gained more and more traction."
The National Academies of Sciences, Engineering, and Medicine are toughening their financial conflict-of-interest policies after publishing reports that some critics have said are tainted by undisclosed corporate influences.

The 154-year-old scientific academy, chartered by Congress during the Lincoln administration, has long enjoyed a reputation as a top-quality producer of in-depth, impartial academic analyses on a range of national policy questions.

But that reputation has been challenged by complaints about two reports — one on medical pain relief and another on genetically modified organisms — whose authors’ ties to industry were not made clear.

In response, the leadership of the private, nonprofit National Academies has agreed to a review of conflict-of-interest policies that it last updated in 2003. As part of that process, the academies already have decided to start noting potential financial conflicts involving study-panel members as part of their published reports.

"The idea that we need to do this has just gained more and more traction" in the last couple of years, said James F. Hinchman, deputy executive officer of the National Research Council, the research arm of the National Academies, of the planned review.

Naming Research Conflicts?

That position marked a shift from just last month, when the National Academies dismissed an outside analysis of a May 2016 report on genetically engineered crops as an unfair rejection of "our tested and trusted conflict-of-interest policies."

The analysis, published by the Public Library of Science in its journal PLOS One, was written by Sheldon Krimsky, a professor of humanities and social sciences at Tufts University, and Tim Schwab, a researcher with the advocacy group Food and Water Watch. Mr. Krimsky and Mr. Schwab said the National Academies report had been produced by a 20-member panel with at least six members who "had one or more reportable" financial conflicts of interest, none of which were disclosed in the report.

Those six members were all university researchers whose grant support or patentable discoveries suggested alliances with producers of genetically modified organisms, or GMOs, Mr. Krimsky and Mr. Schwab wrote. None of the 20 panel members could be found to have any significant alliances with groups skeptical of GMOs, Mr. Krimsky and Mr. Schwab said. The National Academies report largely gave GMOs a clean bill of health, concluding that such organisms could not be associated with environmental or safety problems.

That followed a 2014 analysis by the Milwaukee Journal Sentinel and MedPage Today of a 2011 study by the Institute of Medicine, now the National Academy of Medicine, on managing chronic pain. The publications found that nine members of the institute’s 19-expert panel had current or recent connections to companies that manufacture narcotic painkillers.

The analysis suggested the institute’s report exaggerated the need for new opioid therapies, aggravating an emerging nationwide crisis in the overuse of opioids.

The National Academies initially responded to the criticism by defending the rigor of the process.
The National Academies initially responded to the criticism by defending the rigor of the process by which they produce some 200 reports each year, including an extensive system of iterative, blind peer review. The academies faulted Mr. Krimsky and Mr. Schwab for applying some measures of financial conflict that were stricter than current National Academies policies.

But Mr. Hinchman, in an interview, conceded that it may be time for the National Academies to update those measures and make other changes, including giving the reports' readers clearer information on when conflicts are identified.

As a general rule, the National Academies tries to exclude experts — often, academic scientists — who have financial conflicts pertaining to the subject matter of a study panel on which they serve, Mr. Hinchman said. Last year, he said, the academies used some 5,500 experts for panels. Only 14 had what the academies considered a relevant conflict.

The names of those panelists have been noted on the academies’ website, but they have not been identified in the bodies of the actual reports, Mr. Hinchman said. But an academies spokesman, William Kearney, said on Monday that the academies would immediately begin noting such names both in the final reports and in the draft versions of the reports sent to peer reviewers.

One other immediate change, Mr. Kearney said, involves the academies’ staff. All staff members will now be required to follow the same reporting policies for potential financial conflicts of interest, covering themselves and family members, that apply to panel members, he said.

The president of the National Academy of Sciences, Marcia McNutt, plans to further discuss potential financial conflicts in an address next Monday at the annual meeting of the academy, in Washington, Mr. Kearney said.

A ‘Gratifying’ Commitment

The issue has persisted for the academies, despite the role of their own reports in encouraging more attention to the problem of potential financial conflicts among universities, journals, and public and private funders of research. Back in 1975, the science writer Philip M. Boffey, a former Chronicle reporter, published an investigative book, The Brain Bank of America, that found widespread problems with reports by National Academies panels with multiple corporate interests in the outcomes. As late as 1998, the academies reported that 24 percent of study-panel members had worked for industry.

The academies have taken a series of steps since then to tighten their policies, most recently in 2003. But the academies continue to accept extensive financial support from industry that is not directly noted in relevant reports, Mr. Krimsky and Mr. Schwab wrote. As part of their PLOS One report, they noted that three major farm-biotechnology companies — Monsanto, DuPont, and Dow — have each reported giving the academies $1 million to $5 million. That money was not noted in the GMO report, they said.

The academies’ commitment to review their policies is "gratifying," Mr. Krimsky said in an interview. His report offered a series of specific suggestions for changes, including eliminating $10,000 as a threshold for defining a potential financial conflict.

The National Institutes of Health uses a threshold of $5,000, though Mr. Krimsky said that scientific literature shows that the outcomes of studies funded by private companies — in a variety of fields — tend to align with the financial interests of those companies regardless of the size the financial relationship.

Mr. Krimsky and Mr. Schwab also suggested that the academies consider disclosures covering at least the previous three years, rather than just "current" financial ties, and that they report the previous three years of financial support from any companies affected by a particular study.

They also called on the academies to end their practice of keeping private any information submitted by outside commenters that raise allegations of potential financial conflicts among panel members.

‘The World Gets More Complex’

Peer reviewers of both the GMO report and the chronic-pain report said they welcomed the prospect of changes even though they expressed confidence in the academies’ work and didn’t know of any unaddressed problems with the projects they had evaluated.

Joshua M. Sharfstein, a professor of the practice at the Johns Hopkins University who served as a reviewer for the pain-management study, said he regards the problem of potentially biased studies as a challenge for the whole medical profession, not just the academies.

Kathleen Hall Jamieson, a professor of communication at the University of Pennsylvania who served as a reviewer for the GMO study, said the academies’ extensive peer-review process helps overcome any biases that may exist among panel members. "They review things all but to death," Ms. Jamieson said.

Nevertheless, she said, "it is always a good thing to revisit the standards in place as the world gets more complex."

Still, some academics regard the National Academies as so devoted to being impartial and unbiased that their reports can lack sharp messages that may be necessary on certain topics.

"The National Academies are unusually careful as a general rule," said Richard M. Shiffrin, a professor of psychological and brain sciences at Indiana University at Bloomington who helped lead an academies-hosted colloquium last month on the trustworthiness of science.

"Every time that someone doesn’t want to agree with some report or some conclusion," Mr. Shiffrin said, "one way of trying to deal with it is to attack the credibility of the panel." Yet, he added, "in almost every way to Sunday, it’s a fact that the most complaints by scientists about these committees and panels or reports is that they’re too careful."

Paul Basken covers university research and its intersection with government policy. He can be found on Twitter @pbasken, or reached by email at paul.basken@chronicle.com.

Correction (4/25/2017, 10:54 a.m.): This article originally misstated the nature of the annual meeting at which Ms. McNutt will speak. It is the annual meeting of the National Academy of Sciences, not of the entire National Academies. The article has been updated to reflect this correction.