Professionalism/Deborah Rice and the American Chemistry Council

In 2008, a chemical lobbyist group ousted toxicologist Deborah Rice from an U.S. Environmental Protection Agency (EPA) expert review panel. The implications of this action provide insight into the topic of professional conflicts of interest. This chapter summarizes the events that led up to the ousting and explores in detail the different interpretations of conflicts of interest.

Background


Dr. Deborah Rice is an internationally renowned toxicologist who has been studying toxicology for over 30 years. Her specialization is in neurotoxins. In 2008, she worked for the Maine Department of Disease Control and Prevention, where she conducted research on deca-PBDE, a member of the family of Polybrominated Diphenyl Ethers. PBDE's are commonly used as fire retardants. Through her research on deca, Rice concluded and presented clear, thorough and accurate scientific evidence that the chemical poses serious health risks to humans, animals and the environment. She was instrumental in helping Maine and other states pass a bill to ban deca from household products.

Before her employment at the Maine Department of Disease Control and Prevention, Rice was a senior risk assessor in the National Center for Environmental Assessment at the U.S. Environmental Protection Agency (EPA). She was among five scientists to win an award from the EPA in 2004 for "exceptionally high-quality research" into lead exposure's ability to cause premature puberty in girls.

Due to the rising concern over the potentially hazardous effects of deca, the EPA decided to call a panel of experts to review the safety of the chemical in 2006. The agency selected Rice as the chairperson of the panel to review the safety of deca because of her knowledge of the subject. Although the panel was meant to merely review and comment on the scientific research surrounding deca, the EPA planned to use the produced report to set new safety standards for deca. The results of this panel were highly anticipated because if the EPA set exposure levels that were really low, the market for consumer products containing deca would suffer. This was a concern with many parties including the manufacturers and their lobbyists. The report from this panel was published by the EPA at the end of February, 2007.

In May 2007, Sharon Kneiss, a Vice President of the American Chemistry Council (ACC), wrote to the EPA asking for Deborah Rice's removal from the panel. In the letter, Kneiss alleged that Rice held a biased opinion and that she was therefore undeserving of the position as chair of an objective panel.

The EPA removed Dr. Rice from the panel as requested by the ACC. The agency removed all of Deborah Rice's comments from the report and republished it without any mention of changes to the original document. Months later, the EPA issued a disclaimer on the report, which stated that the agency removed Rice's comments due to a potential 'conflict of interest.'

The Environmental Working Group’s line-by-line comparison of the panel report before and after EPA stripped Dr. Rice’s comments from the document shows that the altered document is now missing major concerns relevant to deca’s risks. Particularly at risk were vulnerable populations such as infants and children.

Reactions to Rice's Removal
Rice's removal from the EPA panel elicited reactions from both sides of the deca controversy. Supporters of a ban on deca called into question the integrity of EPA review panels. Opponents of the ban were then left to defend the actions of the EPA.

EPA
After the incident, the EPA conducted an investigation into Rice's removal from the panel to quell accusations about the legality of the issue. The agency published the results of the investigation in January 2009 in a report from the EPA's Office of Counsel Legal Review. The investigation ruled that Rice's removal was justified legally because Rice was not forthcoming about her involvement in the deca issue. Each of the potential panelists was asked the following question in October 2006: “Have you made any public statements or taken positions on or closely related to the subject chemical or topic under review?” A review of the records from the panel selection process revealed that Rice replied “No” to this question. In February 2007, after the EPA chose Rice for the panel, she again denied that she held a conflict of interest in the deca issue. Her response came just one day after she testified in Maine legislature in an endorsement for a ban on deca. Although the investigation ruled Rice's removal legal, the report did suggest improvements for future panel selection processes, stating “we suggest that National Environmental Assessment Center (NCEA) consider establishing a procedure by which allegations of conflict of interest of lack of impartiality, raised after peer review panel has convened, can be addressed.”

Environmental Protection Groups
In March 2008 the Environmental Working Group (EWG) launched an aggressive attack on the EPA following the removal of Deborah Rice from the deca expert review panel. The group began its attack on deca in 2004 because of the substance’s potentially harmful effects on people and the environment. EWG’s campaign for the reinstatement of Rice’s comments researched seven external review panels that were similar to the deca panel, and found seventeen EPA panelists who portrayed potential conflicts of interest. These 17 panelists fell into four categories: those with financial ties to chemical companies, those who previously made possibly biased public opinions, those who have a record of weakening health standards, and those who consult with chemical companies whose chemicals are under review.

The Natural Resources Defense Council (NRDC) joined with the EWG to submit a formal request for the EPA to reinstate Rice’s comments on the deca panel. Interestingly, both organizations are clients of the Washington, D.C. based PR firm Fenton Communications. The request included a recommendation that the EPA implement a more transparent process for addressing conflicts of interest.

Scientific Integrity Groups
Numerous social groups echoed the opinions of the EWG and NRDC, including the Integrity in Science project, the Center for Science in the Public Interest, Public Employees for Environmental Responsibility (PEER), the Union of Concerned Scientists, and the National Treasury Employees Union of the EPA.

Fire Safety Retardants Lobbyists
In 2008, Sharon Keiss presented a report to the House of Representatives Committee on Energy & Commerce about scientific integrity at the EPA. She stated that the ACC did not call for Rice's removal, but only requested that a new panel form with impartial participants. The ACC was not satisfied with the EPA's actions. Although the EPA removed Rice's comments from the deca report, the decisions made by Rice and the rest of the deca panel were still incorporated into EPA regulations. Keiss stated, "Symbolically, while the chair's name may have been removed from the final report of the peer reviewers, she remains listed today as a chair of the panel in the final toxicological assessment."

Deborah Rice
Rice issued a statement that detailed her role in the controversial process. She testified, “I believe that having an informed scientific opinion constitutes neither bias nor conflict of interest. Indeed, if this is the definition of bias, then only individuals who are uninformed on a particular chemical would be considered suitable to serve as peer reviewers.”

Conflicts of Interest in Peer Review
Groups involved in peer review address conflicts of interest in different ways. The EPA's stance on conflicts of interest is similar to those of peer reviewed journals and of the Food and Drug Administration (FDA).

Peer Reviewed Journals
Peer reviewed journals clearly state their policies on conflicts of interest, as do government agencies. Similar to the EPA's Handbook for Peer Review, these guidelines apply to peer reviewer selection but do not list out processes for addressing conflicts of interest that may arise during the review period. Nature's policy includes a detailed description of competing financial interests that the journal considers significant. The journal allows its referees to excuse themselves from any review processes in which they have such a conflict of interest. While financial interests are specifically spelled out, reviewers are asked to excuse themselves for conflicts of interest, "financial or otherwise", though the non-financial conflicts of interest are never explicitly listed.

Environmental Protection Agency
The EPA Handbook for Peer Review, 3rd ed., states that the majority of efforts to adhere to federal ethics legislation come down to the issue of whether or not potential peer reviewers have "an ethics issue with respect to a 'conflict of interest' or 'an appearance of a lack of impartiality'." Conflicts of interest can be either financial or non-financial in nature, while "appearance issues" come down to the judgement on the part of the determining official as to whether or not one exists. Issues of industry influence were a major concern in the case of Dr. Rice, prompting an investigation by the U.S. House of Representatives Committee on Energy and Commerce in 2008.

Food and Drug Administration
The problem of finding experts without conflicts of interest is not limited to the EPA. The FDA had similar struggles in their searches to find unbiased experts for review panels. In 2007 the FDA made their review panel selection guidelines stricter. Prior to this set of changes, 73% of FDA expert panels reported that at least 1 member disclosed a conflict of interest, though only 1% of advisory board members were recused. According to Janet Woodcock, director of the FDA's  Center for Drug Evaluation and Research,"There is no doubt it is difficult finding highly experienced people who do not have conflicts." While conflicts of interest on expert panels have been greatly reduced, the rate of vacancies on FDA panels hovers around 20%, which is twice the FDA's published target of 10%. For the FDA, the main concern is limiting ties to industry amongst members on advisory panels, and strictly enforcing rules against these ties has led to fewer experts serving on panels. This leaves more work for the remaining panelists and fewer professionals reviewing each drug.

Implications for Professionals


A recent review found that attempts to create policy measures to effectively regulate non-financial conflicts of interest have been unsuccessful due to the difficulties related to defining what constitutes a conflict. While many organizations have failed to monitor and discourage reviewer's competing interests, the Public Library of Science (PLoS) policy on competing interest comes close to managing these issues.

PLoS asserts that while most people have some form of non-financial conflicts of interest that likely do not affect their objectivity, individuals should disclose all of their known conflicts of interest so that others can fully evaluate any potential biases. However, ultimately the judgement of the potential for bias rests on the editors, which requires a high level of professionalism on the editors' parts. Similarly, professionals reading peer-reviewed reports must use their judgement to determine how conflicts of interest might bias reported results and decide for themselves how to interpret the results.