Time to come clean: IRIS needs to require stakeholders attending its meetings to disclose their conflicts of interest

Richard Denison, Ph.D., is a Lead Senior Scientist.  Lindsay McCormick is a Research Analyst.  

EPA’s Integrated Risk Information System (IRIS) has been implementing a number of changes in the last couple of years, in response to criticism and concerns coming at it from all sides.  As stated on its website:  “These enhancements will improve productivity and scientific quality in IRIS assessments and help EPA meet the goal of producing IRIS assessments in a timely and transparent manner.”  IRIS has noted that increasing “stakeholder engagement is an essential part of the enhancements.”

Simultaneously pursuing these lofty goals of increasing throughput, scientific quality, transparency and stakeholder engagement in IRIS assessments is challenging, to say the least.  EDF has and will continue to emphasize the need to strike a balance between these goals, given that overemphasis on one can actually exacerbate the problems aimed to be addressed by another.

In this somewhat lengthy post, we’ll examine one such serious problem – skewed participation in IRIS’ bimonthly meetings.  We’ll look at steps EPA has taken to partially address the problem, and argue that the lack of adequate disclosure by participants of conflicts of interest remains a major unaddressed contributing factor.  We’ll discuss our recommendations for full disclosure and point to the strong precedents for such disclosures in other venues.  

Skewed participation in IRIS’ bimonthly meetings

IRIS’ addition of bimonthly meetings with an open registration process – intended to provide, among other things, an opportunity for increased stakeholder engagement – has actually exacerbated the imbalance in stakeholder input EPA receives, a concern we blogged about earlier and expanded on in comments we submitted to the IRIS program.  These meetings are now overwhelmingly dominated by industry speakers with vested interests in the chemicals and methodological issues under discussion.

This very outcome was anticipated if not predicted in the National Research Council (NRC) report on the IRIS Process (page 5) released earlier this year, which noted that “not all stakeholders who have an interest in the IRIS process have the same scientific or financial resources to provide timely comments, and expanded opportunities for stakeholder involvement might lead to a further imbalance of public input.”

Or as one of us put it a little more bluntly recently (subscription required):  “We remain very concerned about the gross imbalance in stakeholder participation, and are concerned that IRIS adding more meetings has exacerbated the problem.  That’s because industry can afford to cover all such meetings, and pay its consultants to attend as well, whereas NGOs, who are already stretched, are even less able to contribute.”

In response to this problem, IRIS has recently announced it has contracted with the NRC to identify “independent experts” to participate in IRIS’ bimonthly meetings, presumably in part to offset the skewed participation by industry interests.

This approach is laudable and one we support.  EDF has been working for some time to increase active participation by independent researchers in EPA’s scientific activities; see, for example, this recent commentary co-authored by our colleague Dr. Jennifer McPartland.

Failure to require disclosure of financial conflicts of interest

But this approach alone remains insufficient to address another dimension of the problem of skewed participation: that many individuals providing oral or written comments to IRIS have failed to adequately disclose their financial ties to companies and trade associations with vested interests in the topics their comments are addressing.

Look at this final meeting agenda for IRIS’ June 2014 bimonthly meeting.  Note on the first day’s agenda (which addressed hexavalent chromium) all but one of the numerous speakers who are employees of, or are representing, the industry consulting firm, ToxStrategies, do not identify anyone other than ToxStrategies on whose behalf they are speaking.  And you can see on the second day’s agenda (which addressed inorganic arsenic), one of the speakers from another industry consulting firm, Gradient, and the speaker from the University of Nebraska Medical Center also do not identify anyone other than their direct employers on whose behalf they are speaking.

After our experience with this meeting, EDF identified one obvious reason why many industry-affiliated speakers were failing even to disclose on whose behalf they were speaking:  The meeting registration form marked as “optional” the field for indicating if a registrant is speaking on behalf of another entity.  EDF raised this concern with IRIS staff, who removed the “optional” label.  That seems to have helped on this narrow aspect of the problem:  Subsequent agendas (see here and here) do indicate on whose behalf most industry-affiliated participants are speaking.

But this “disclosure-lite” approach does not adequately make transparent the extent to which stakeholder input provided by industry-affiliated speakers is influenced by direct or indirect financial conflicts of interest they may have.  That is because merely indicating on whose behalf you are commenting does not disclose the nature and extent of any financial relationships between the speakers and the entities on whose behalf they are speaking.  Nor does it disclose the extent to which the sponsoring entity has had direct input into or influence over a speaker’s comments.  We’ll have more to say below about what disclosures are needed.

Lest you think such lack of disclosure is only an artifact of the meeting agenda, in fact it extends to most of the presentations given by these speakers, which are posted on IRIS’ website (see here for the June 2014 meeting stakeholder presentations), as well as to written comments submitted to the IRIS docket for a given chemical (the hexavalent chromium docket is here; the inorganic arsenic docket is here).

Here are some examples of just how spotty or non-existent the disclosures are:

Hexavalent Chromium

  • ToxStrategies
    • As listed on the agenda:
      • 11 presentations are listed on the agenda, given by 8 different speakers
      • Only 1 of the 8 speakers identified on whose behalf she was speaking (“on behalf of the Electric Power Research Institute”)
    • On the presentation materials:
      • 6 presentations are provided on the IRIS website
      • Only 2 identify who supported the work (“supported by ACC”)
    • On the written comments:
      • 2 sets of comments were submitted
      • Neither discloses who supported the work

Yet other information – not made available to the IRIS meeting participants – makes quite clear that this work was paid for by industry with financial interests in hexavalent chromium.  Four of the same ToxStrategies staff who presented at this meeting are co-authors on a 2014 paper published in the journal Food and Chemical Toxicology that includes the following disclosure – because it is required by the Journal:

This work was supported by the Cr(VI) Panel of the American Chemistry Council (ACC). The funders were given the opportunity to review the draft study design, as it went through an external peer review process, and draft manuscripts at the time of external peer review. The purpose of the review was to allow input on the clarity of the science presented but not in interpretation of the research findings. The contents of this review reflect solely the view of the authors.  (emphasis added)

Note the prominent role of the funder, ACC, in all phases of the work.

Ironically, the conflict of interest disclosure in the journal reveals:

The authors [CT, MH, DP, CK, LH] have presented study findings in meetings with regulators including public meetings on behalf of the Cr(VI) Panel of the ACC.

Unfortunately, attendees at the June 2014 IRIS meeting were not privy to information required to be disclosed by the journal – because ToxStrategies chose not to be so forthcoming.

Inorganic Arsenic

  • Samuel Cohen, University of Nebraska Medical Center
    • As listed on the agenda:
      • 5 presentations are listed on the agenda
      • None identified on whose behalf he was speaking
    • On the presentation materials:
      • 4 presentations are provided on the IRIS website
      • None identify who supported the work
    • On the written comments:
      • 2 sets of comments were submitted
      • Neither discloses who supported the work
  • Gradient Corp.
    • As listed on the agenda:
      • 9 presentations are listed on the agenda, given by 2 different speakers
      • Only 1 of the 2 speakers (1 of the 9 presentations) identified on whose behalf he was speaking (“on behalf of Arsenic Science Task Force”)
    • On the presentation materials:
      • 7 presentations are provided on the IRIS website
      • None identify who supported the work (the Arsenic Science Task Force)
    • On the written comments:
      • 2 sets of comments were submitted
      • Both disclose who supported the work
  • Exponent Inc.
    • As listed on the agenda:
      • 6 presentations are listed on the agenda, given by 2 different speakers
      • Both speakers identified on whose behalf he was speaking (“on behalf of Arsenic Science Task Force” or “on behalf of Rio Tinto [an ASTF member]”)
    • On the presentation materials:
      • 4 presentations are provided on the IRIS website
      • None identify who supported the work
    • On the written comments:
      • 3 sets of comments were submitted
      • 1 directly discloses who supported the work
      • The other two refer to published papers; each of the papers does have a disclosure, as required by the journal (Toxicology)
      • The disclosures in the papers note:  “The sponsor[s] was [were] not provided with a copy of this manuscript for review prior to submission, nor allowed input in the conduct [or reporting] of the work.

Yet other information makes quite clear that this work was paid for by industry with financial interests in inorganic arsenic.  A letter dated October 9, 2014, submitted to IRIS by an industry consortium, the Arsenic Science Task Force (ASTF), lists ongoing studies being sponsored by ASTF and the principal investigators.  Dr. Samuel Cohen, Gradient and Exponent are specifically named as currently receiving financial support from ASTF to conduct studies on inorganic arsenic.  Yet Dr. Cohen did not disclose this financial conflict of interest at all, and Dr. Barbara Beck of Gradient and Dr. Joyce Tsuji of Exponent did so incompletely.

This is not the first time two of these same individuals have failed to disclose their financial ties to the arsenic industry.  In April 2013, both Beck and Cohen gave presentations at a meeting of the National Academy of Sciences in which they did not disclose that they received funding from at least two major producers of arsenic-laden pesticides, Luxembourg-Pamol and Drexel Chemical Co.  Tsuji also spoke at that meeting, but her presentation did disclose that the work had been supported by Rio Tinto.

Needed disclosures

To address these problems of spotty or nonexistent disclosures, EDF recommends that IRIS require all registrants for its meetings, and all parties submitting written comments to IRIS, to provide the following specific information:

  1. Identify any organization(s) on whose behalf you are presenting comments or by whom you have been paid to work on the chemical(s) or scientific issues under discussion.
  2. Identify the nature of any financial relationships you currently have or have recently had with those organizations.
  3. Identify the funding source(s) for any research or analysis you have done or contributed to on the chemical(s) or scientific issues under discussion.
  4. Indicate whether the sponsoring or funding organizations, or any other organizations that have or represent organizations that have a financial interest in the chemical(s) or scientific issues under discussion, have had input into or have reviewed the presentation or comments you are providing.

(The fourth of these is particularly important in light of the highly influential role played by the funder, ACC, in the work ToxStrategies presented at the IRIS meeting on hexavalent chromium.)

IRIS and/or the participants should also make these disclosures public:

  • for meetings, clearly and prominently marked on the meeting agendas and on all presentation materials, and briefly noted orally; and
  • for submitted comments, clearly and prominently noted in the comments and made public along with the comments.

Strong support/precedents for such disclosures

There is strong support in other venues for these very types of disclosures.

1.  Administrative Conference of the United States (ACUS) Recommendation 2013-3, Science in the Administrative Process, Item #11, page 7:

11. Conflict of Interest Disclosure. Agencies should require conflict of interest disclosures on all scientific research submitted to inform an agency’s licensing, regulatory, or other decisionmaking processes. This disclosure should be similar to the conflict of interest disclosure required by some scientific journals, such as that used by the International Committee of Medical Journal Editors. The regulatory conflict of interest disclosure should also, where permitted by law, identify whether the experimenter or author had the legal right without approval of the sponsor of the research to: design the research; collect the data; interpret the data; and author, publish or otherwise disseminate the resulting report or full dataset. To the extent that a party other than the principal investigator (e.g., the study sponsor or funder) had control over the design or publication of the study, agencies should disclose this fact and specify the nature of the control such an entity exercised.

2.  OSHA proposed rule on “Occupational Exposure to Respirable Crystalline Silica,” 78 Fed. Reg, September 12, 2013, p. 56274:

If you submit scientific or technical studies or other results of scientific research, OSHA requests (but is not requiring) that you also provide the following information where it is available: (1) Identification of the funding source(s) and sponsoring organization(s) of the research; (2) the extent to which the research findings were reviewed by a potentially affected party prior to publication or submission to the docket, and identification of any such parties; and (3) the nature of any financial relationships (e.g., consulting agreements, expert witness support, or research funding) between investigators who conducted the research and any organization(s) or entities having an interest in the rulemaking. If you are submitting comments or testimony on the Agency's scientific and technical analyses, OSHA requests that you disclose: (1) The nature of any financial relationships you may have with any organization(s) or entities having an interest in the rulemaking; and (2) the extent to which your comments or testimony were reviewed by an interested party prior to its submission. Disclosure of such information is intended to promote transparency and scientific integrity of data and technical information submitted to the record. This request is consistent with Executive Order 13563, issued on January 18, 2011 [Section 5, “Science”], which instructs agencies to ensure the objectivity of any scientific and technological information used to support their regulatory actions. OSHA emphasizes that all material submitted to the rulemaking record will be considered by the Agency to develop the final rule and supporting analyses.

3.  Disclosure policies of many leading scientific journals, including Nature, which published this editorial calling for such disclosures in March, 2014.  One salient excerpt:

In areas where tough standards are needed to protect public health, and powerful and wealthy interests have a financial incentive to water down these standards, such transparency is more than desirable — it is essential, and history demonstrates that. Rather than challenging OSHA for requesting conflict-of-interest disclosures, US politicians should be asking why all federal agencies do not require them.

Other examples of journals’ conflict of interest (COI) disclosure policies:

(Note:  EHP and ES&T authors must affirmatively declare they have do NOT have any COI if that’s the case.)

Conclusion

Requiring disclosures of the sort we request by IRIS would have at least two beneficial effects.  First, it would ensure the public as well as IRIS staff are fully informed as to whether the input stakeholders are providing to EPA may be colored by those stakeholders’ financial ties to companies or trade associations with a vested interest in the outcome of IRIS assessments.  The public has a right to know the full basis on which government agencies and programs such as IRIS are making decisions that have the potential to affect public health and well-being.

Second, requiring such disclosures could directly address the imbalance in recent meetings by reducing the flood of industry-affiliated registrants for IRIS meetings through shining a more illuminating public spotlight on the extent of industry efforts to influence IRIS’ work.

Industry is, of course, a legitimate stakeholder in the IRIS process.  But it’s time to ensure their representatives come clean about the degree to which they and their hired hands have financial interests that, whether in whole or in part, motivate them to so vociferously seek to influence the outcomes of IRIS assessments.

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