EDF Health

Selected tag(s): Conflict of interest

Doublespeak is alive and well in the ACC-backed “SAB Reform Act”

By / Published: December 19, 2013

Richard Denison, Ph.D., is a Senior Scientist.

George Orwell would be proud. 

Yesterday a Senate copycat of a House bill called the “EPA Science Advisory Board Reform Act of 2013” was introduced.  The Senate bill has yet to be made publicly available, but that didn’t stop the American Chemistry Council (ACC) from sending out its own release strongly supporting the bill, literally within minutes of the issuance of a press release by the bill’s main sponsors.

Assuming (as stated in the release) that the Senate bill is the same as the House bill, H.R. 1422, no wonder ACC loves this bill: 

  • Tired of having your companies’ scientists and hired consultants excluded from SAB panels because of conflicts of interest?  Write a bill that eliminates such a pesky rule, and then say the bill “eliminates conflicts of interest.”
  • Frustrated by the time limit placed on comments from the army of industry commenters that typically show up at SAB panel meetings?  Bar the setting of any time limit so you can stack the deck, and then say the bill “promotes fairness” and “strengthens public participation.”
  • Unhappy with how many independent academic scientists are seated on SAB panels?  Require not only that panel members be willing to devote their time to review lengthy EPA documents, but that they respond in writing to every public comment received – a massive expansion in the workload placed on panel members, given the flood of industry comments typically provided – and then say the bill “promotes transparency.”
  • Upset with academic scientists on SAB panels that receive government grants not always supporting the industry position?  Claim that they are the ones who have conflicts of interest, single them out for disclosure of their grants and contracts – with no mention of industry consultants – and then say the bill “increases disclosures” related to potential conflicts.  (An earlier version of the bill would actually have set a 10% quota for government-funded scientists on SAB panels; happily that was removed after an outcry.)
  • Want to slow down the pace of EPA risk and hazard assessments?  Require that every single such assessment be sent to SAB for review, exponentially expanding the SAB’s workload and adding months or years to the process of finalizing assessments, and then say the bill merely “enables SAB reviews” of such documents.

Despite its grand claims, the EPA SAB Reform Act is nothing more than a thinly veiled attempt by ACC and its Hill allies to heavily stack the deck in its favor when it comes to independent scientific reviews of EPA work products.

When the House bill was introduced earlier this year, more than a dozen of the country’s premier public health scientists weighed in strongly opposing the bill, as did a group of prominent environmental NGOs.  See those letters for more details.

While the bill clearly parrots the talking points of the chemical industry when it comes to peer review of government chemical assessments, it should be noted that the bill would apply to any and all aspects of SAB’s work, not just that on chemicals.  So scientists in all fields of endeavor relating to protection of health and the environment ought to be concerned.

 

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Avoiding conflict and delay: EDF comments to yet another IRIS review panel

By / Published: April 5, 2013

Richard Denison, Ph.D., is a Senior Scientist.

Chemical industry representatives and their consultants often argue that they should be on panels reviewing government assessments of their chemicals because “they know their chemicals best.”  Well, the mother of a young man accused of a crime may well know her son better than anyone – but that doesn’t mean we should seat mom on the jury.

I made that comment as part of my public comments delivered at this week’s meeting of a new committee formed by EPA’s Science Advisory Board, which has a charge of peer reviewing chemical assessments developed by EPA’s Integrated Risk Information System (IRIS) program.  (If you’re a regular reader of this blog and you feel like you’re having a déjà vu, yes, this is yet another panel set up to oversee or assess IRIS; see this earlier post.)  I felt compelled to make that comment in part because in the preceding day and a half of the meeting, well over half of the comments offered by the 26-member committee came from just four of those members, all of them industry consultants.

It turns out that the assigned members of the committee, named the Chemical Assessment Advisory Committee, or CAAC (I recommend just saying C-A-A-C, rather than trying to pronounce the acronym), have not yet been screened for potential conflicts of interest (COI) or lack of impartiality.  This step won’t happen until later, when a subset of committee members are tapped to serve on a review panel for a specific IRIS assessment.  But this process made for an awkward meeting, which was supposed to be limited to a “fact-finding” briefing by the IRIS program, but constantly veered into territory verging on providing advice to EPA (again dominated by the industry consultants).  Federal law requires that any committee offering such advice be free of conflicts of interest in all but the most exceptional of circumstances.

In my comments, I raised concerns about the high potential for conflicts of interest to arise, given the composition of the committee.  I also reiterated the points I have made to other similar panels that getting the science right in IRIS needs to be balanced with ensuring that IRIS assessments are completed in a timely manner — because there are real-world adverse public health consequences to the delays that have plagued the IRIS program.

Read on for my full comments. Read More »

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EDF comments at National Academy of Sciences workshop on “weight of evidence” in chemical assessments

By / Published: March 29, 2013

Richard Denison, Ph.D., is a Senior Scientist.

This week I attended a workshop sponsored by the National Academy of Sciences’ Committee to Review the IRIS Process.  This committee was established in response to a rider attached to an “omnibus” spending bill passed by Congress in late 2011.  The committee’s charge is to “assess the scientific, technical, and process changes being implemented by the U.S. Environmental Protection Agency (EPA) for its Integrated Risk Information System (IRIS).”

EPA describes IRIS as “a human health assessment program that evaluates information on health effects that may result from exposure to environmental contaminants.”  The key outputs of IRIS assessments are one or more so-called “risk values,” quantitative measures of an “acceptable” level of exposure to the chemical for each cancer and non-cancer health effect associated with the chemical.  IRIS risk values are in turn used by regulators to set everything from cleanup standards at Superfund sites to limits in industrial facilities’ water discharge permits.

This week’s workshop – a detailed agenda is available here – was intended to provide expert input to the committee to inform its review of IRIS.  It focused on the complex and controversial issue known as “weight of evidence” (WOE) evaluation.  Here WOE refers to how EPA – in conducting an IRIS assessment of a particular chemical – selects studies, evaluates their quality, and assesses and integrates their findings, as well as how it communicates the results.  At issue in particular in a WOE evaluation is how the assessor determines the relative importance – or weight – to be given to each study.

One of the many issues that came up in the discussion of WOE is how to identify and assess the “risk of bias” in individual studies – a concept borrowed from the evaluation of the reliability of clinical trials used in drug evaluations.  (See this Powerpoint presentation by one of the committee’s members, Dr. Lisa Bero, which provides a nice overview of risk of bias in that setting).  Evaluating a study’s risk of bias is critical for assessing its quality and in turn the weight it should be given, because bias in studies can result in significant under- or overestimates of the effects being observed. 

One type of bias is so-called “funder bias.”  Dr. Bero and other researchers have documented through extensive empirical research that there is a significantly increased likelihood that a study paid for by a drug manufacturer will overstate the efficacy or understate the side effects of a drug.  As to studies of environmental chemicals, at the workshop and more generally, the chemical industry has pointed to adherence to Good Laboratory Practice (GLP) standards as a sufficient antidote to bias, including funder bias, a notion that has been heartily disputed by others.

But enough background.  My intent here is not to fully describe the workshop discussions, but rather to provide the comments I presented during the public comment period at the end of the meeting.  My comments addressed the issue of funder bias and also sought to urge the committee not to dive so deeply into the weeds in reviewing and proposing enhancements to EPA’s IRIS process that it loses sight of the need for a workable IRIS process that is able to provide in a timely manner information so critical to ensuring public health protection.

Read More »

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Scientists push back against a bill that would pervert the whole concept of conflict of interest

By / Published: December 7, 2012

Richard Denison, Ph.D., is a Senior Scientist.

This week, two letters – one signed by 13 prominent public health scientists and the other signed by the heads of 8 major national environmental organizations – were sent to the House Science Committee voicing strong opposition to H.R. 6564, the EPA Science Advisory Board Reform Act of 2012.

The sponsors of this legislation claim that it is needed to “enhance transparency and limit conflicts of interest” on the Environmental Protection Agency’s (EPA) Science Advisory Board (SAB) and its panels.  In fact, it would do the precise opposite.  Here’s how the scientists’ letter summarizes the impacts that would arise from passage of the bill:   

“This proposed legislation would only serve to reverse progress in bringing the best scientific advice and analysis to EPA.  The consequence would be to deprive EPA of needed scientific advice on the most complex and pressing environmental health problems of our day.” 

Among the most perverse provisions of this bill (and there are many) are two that would turn the very notion of conflict of interest on its head.  One would limit scientists that receive competitive grants through EPA’s extramural research program from serving on the SAB or its panels – claiming that such funding constitutes a conflict of interest.  The scientists’ letter goes directly at that provision:

“The underlying idea that scientists who obtain funding from EPA for any project have conflicts about all EPA matters is baseless and reflects a misunderstanding of who we are as scientists and our role in society.”

Another provision is even more perverse:  It would reverse longstanding conflict-of-interest policy and practice followed by virtually every authoritative scientific body in the world – including the National Academy of Sciences, the International Agency for Research on Cancer and the World Health Organization – by allowing unfettered access of industry representatives with direct conflicts of interest to serve on the SAB and its panels, as long as their conflicts are disclosed.

Who’s behind this radical legislation?  Here’s a hint:  The American Chemistry Council (ACC), which represents the chemical manufacturing industry, couldn’t wait to express its unequivocal support, stating it “cannot overstate the importance of this bill to Americans” in a press release titled “House Science Committee Proposes Common Sense Reform To EPA Scientific Advisory Process:  Proposed Legislation Would Improve Expert Panel Selection, Limit Conflicts of Interest and Enhance Systematic Reviews.”  And ACC’s been singing the bill’s praises all over town ever since (see, e.g., slide 6 of this ACC presentation).  Read More »

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