National Biotechnology Panel Faces New Conflict of Interest Questions

By STEPHANIE STROM

The National Academies of Sciences, Engineering and Medicine are assigned by Congress to provide policy guidance to the government. The group describes itself as “advisers to the nation.” The advice often comes through written reports from scientific committees organized by the group.

One of those committees, though, is facing questions about how its members were selected. The concerns focus on a panel studying biotechnology, a booming area of business, including in the food industry, and one of the most contentious scientific issues in Washington.

Critics say that several committee members have financial ties to biotech businesses that could color the panel’s report, expected to be published soon, potentially giving short shrift to health and environmental worries.

By the academies’ own account, two of the scientists already violate the group’s extensive conflict-of-interest policy.

Continue reading the main story

In addition, an employee at the academies who helped pick the scientists to serve on the panel was pursuing a different job while he put together his recommendations for the group. Three of the 13 people he recommended — all of whom were eventually selected for the panel — were board members at his new employer, a new biotechnology nonprofit.

The criticism adds to the heated debate about how federal regulators are handling the fast development of biotechnology. The National Academies play an outsize role in the debate because of their stature in the academic community and connections to the federal government. A separate study the organization did on genetic engineering in agriculture, published in May, also came under intense criticism from environmentalists.

The National Academies have defended the panel that produced the May report, as well as the current panel on biotechnology, saying that the type of expertise needed to staff them is limited and thus some conflict must be tolerated.

But people with ties to the academies say any perceived conflicts of interest may undermine some of the group’s authority.

“There’s often a lot riding on what the academies say, and so their ability to act with objectivity and independence defines any value they have,” said Dr. Harvey Fineberg, a former leader of what is now the medical division of the National Academies.

The most recent committee convened to study biotechnology was formed this year at the behest of the White House. The group was asked to predict what new technologies might arise over the next 15 years and advise the government on how to oversee them. The regulation for the industry was last updated in 1992, years before the first approval of genetically engineered seeds, which are now widely used by farmers.

Like the 200 or so other reports published by the National Academies each year, the biotechnology report is undergoing peer review, the quality-control process regularly used by academic journals.

The report could have broad implications for the industry. Big food companies like Coca-Cola and Archer Daniels Midland, for instance, have invested in synthetic biology, a term used for the more sophisticated genetic engineering now coming into use that was the panel’s area of study. Food companies are exploring its use in creating flavorings and sweeteners.

When the National Academies announced the committee this year, they disclosed that two of the group’s 13 scientists had ties to the biotech industry that violated the organization’s conflict-of-interest policy. Such disclosures are rare for the academies, said William Kearney, a spokesman for the organization, but scientists with conflicts are sometimes allowed to work on a committee when the academies think the scientist has a specialty or knowledge that cannot be found elsewhere.

Mr. Kearney would not, however, provide data on how frequently the academies have to disclose such conflicts, saying only that they are “rare.”

The two scientists with conflicts are Dr. Steven Evans, a scientist at Dow AgroSciences, a major biotechnology company, and Jeffrey Wolt, a professor at Iowa State University, who the academies said has investments in a company that could benefit from the study’s results. The academies noted their conflicts when the panel members were announced.

A Panel Rife With Potential Conflicts

Of the 13 men and women named to a panel of the National Academies of Sciences, Engineering and Medicine that will make recommendations to the White House on regulating the biotech industry, seven could be said to have potential conflicts of interest.

COMMERCIAL INTERESTS

Potential

conflicts

Steven P. Bradbury

Owner of Steven P. Bradbury & Associates, a consulting firm that advises companies on biotechnology

Professor of environmental toxicology at Iowa State University

Have commercial interests that could be affected by regulations

on the biotech industry

Co-founder of enEvolv, a firm that re-engineers microbes to create chemicals for industrial use

Farren Isaacs

Asst. professor of molecular, cellular and developmental biology at Yale University

Holds patents for various biotechnology processes

Richard M. Amasino

Professor of biochemistry at the University of Wisconsin, Madison

Disclosed by the National Academies as having a commercial interest that violates the organization’s conflict of interest policy

Jeffrey Wolt

Professor of agronomy and toxicology at Iowa State University

Have been associated with the Engineering Biology Research Consortium, a nonprofit group aimed at promoting the biotech industry

Dow AgroSciences has major interests in the biotechnology industry

Steven L. Evans

Fellow in seeds discovery research and development at Dow AgroSciences

Chief executive and founder of Global Helix, a consulting firm that may advise clients in the biotechnology business

Richard Johnson (resigned)

Former senior partner at Arnold & Porter, an international corporate law firm

Richard Murray

Co-founder of Synvitrobio, a synthetic biology start-up

Professor of bioengineering at the California Institute of Technology

Mary Maxon

Biosciences principal deputy at the Lawrence Berkeley National Laboratory

David Rejeski

Former director of the Science and Technology Innovation Program at the Woodrow Wilson Center for International Scholars

Barbara Evans

Professor of law at the University of Houston Law Center

No apparent conflicts of interest

Jennifer Kuzma

Co-director, Genetic Engineering and Society Center, N.C. State University

Raul F. Medina

Professor of entomology at Texas A&M University

Martha Krebs

Senior scientist in Penn State’s College of Engineering; principal investigator and director of the Consortium for Building Energy Innovation at the Navy Yard in Philadelphia

POTENTIAL CONFLICTS

Steven P. Bradbury

Have commercial interests that could be affected by regulations

on the biotech industry

Farren Isaacs

Richard M. Amasino

Jeffrey Wolt

Have been associated with the Engineering Biology Research Consortium, a nonprofit group aimed at promoting the biotech industry

Steven L. Evans

Richard Johnson

(resigned)

Richard Murray

Mary Maxon

David Rejeski

Barbara Evans

No apparent conflicts of interest

Jennifer Kuzma

Raul F. Medina

Martha Krebs

By The New York Times

Dr. Evans and Professor Wolt referred questions about their role to Mr. Kearney. Mr. Kearney said the disclosed conflicts of interest were discovered during the usual vetting of panel members by the academies. The academies kept the scientists on the panel, he said, because they could not find anyone with the same expertise.

But more than three dozen environmental and health advocates argue that the National Academies also allowed several other scientists with potential financial conflicts onto the panel without any disclosures.

“Several members of this committee stand to benefit directly or indirectly from the rules and regulations their recommendations will help shape,” said Tim Schwab, a food researcher at Food & Water Watch, an advocacy group leading the group of critics. “Nor does the committee include anyone who might advocate a more judicious approach to regulating the industry.”

The group made note of Farren Isaacs, an assistant professor at Yale. Professor Isaacs is a founder of enEvolv, a start-up that engineers tiny organisms “to produce bio-based chemicals.” DuPont, which has major investments in biotech, has funded Dr. Isaacs’s research, and he holds two patents that could be used in synthetic biology.

Professor Isaacs referred questions to Mr. Kearney.

Mr. Kearney said all conflicts that violate the academies’ conflict-of-interest policy had been disclosed when the panel was announced. Professor Isaacs, he said, did not have a conflict that required disclosure because his company’s technologies are not now being used in biotech.

“The term ‘conflict of interest’ applies only to current interests, not prospective ones,” Mr. Kearney said. He said the same about similar questions raised about other members of the committee by the group of critics.

(One panel member resigned: Richard Johnson, a former partner at Arnold & Porter, a law firm that counts many biotech companies as clients. Mr. Kearney attributed the decision to scheduling conflicts.)

The job of finding the scientists to fill the 13 open spots on the biotech committee largely fell to Douglas Friedman, the “responsible staff officer,” or study director. Such employees help the academies identify scientists to serve on a study’s panel, set the agenda for their meetings and oversee the production of the final report, among other tasks.

But while Mr. Friedman, who has degrees in chemistry and chemical biology, was putting together his recommendations, he was also applying for a leadership job in the biotech world.

In January, Mr. Friedman widely distributed an email seeking nominations for the panel. The email was one of many digital records about Mr. Friedman and the panel that were discovered by Food & Water Watch. The group found the records, including the emails and spreadsheets, through Google searches of the panel’s members and shared them with The New York Times, which repeated the search and also found the documents. The records have since been removed from the websites where they had been cached.

One recipient of the email was the Engineering Biology Research Consortium, a nonprofit dedicated to fostering and advancing synthetic biology research.

According to the digital records discovered online, Mr. Friedman was firmly on the nonprofit’s radar as a possible leader by the time he began his search for members for the National Academies panel. Ginni Ursin, a Monsanto executive on the nonprofit’s board, commented on a spreadsheet dated December 2015 that Mr. Friedman was the “top candidate by a decent margin.”

The 13 scientists Mr. Friedman recommended to his superiors at the National Academies — including three members of the nonprofit’s board — were all ultimately approved, he said.

The panel was appointed in April, and in July, Mr. Friedman started as the new executive director of the Engineering Biology Research Consortium.

In a phone interview, he said that he pursued the new job while helping to put the panel together but did not see any reason to tell the academies about the job search. He said he was only one of many layers in the process of appointing members to the biotech panel. And he said it was a coincidence that so many committee members also have roles at the nonprofit.

“It’s a relatively small community of people involved in the biotech space,” he said.

But Mr. Kearney of the National Academies said Mr. Friedman should not have played the role he did in the selection of the committee in the midst of a job search he did not disclose. The National Academies, he said, are reviewing the selection process, including the oversight of the staff members who oversee it.

“No staff member,” he said, “should be participating in the appointment of a committee with members who are also on the board of an organization with which he or she is negotiating employment.”

Correction: January 4, 2017 
A chart on Dec. 28 with article about potential conflicts of interest among members named to a biotechnology panel of the National Academies of Sciences, Engineering and Medicine, using information erroneously posted on the website of the Engineering Biology Research Consortium, referred incorrectly to Mary Maxon and David Rejeski, two of the 13 members of the panel. They do not have any connection to the consortium. As a result, seven of the members of the panel have potential conflicts of interest, not nine. The article, using the same information from the website, misstated the number of people connected to the consortium who are also members of the biotechnology panel. It is three, not five.