Has
the Fox Bought a Ticket into the Chicken Coop?
American Chemistry Council forges
a Memorandum of Understanding with the
National Institute of Environmental Health Sciences.
The National Institute of Environmental Health Sciences has signed a Memorandum of Agreement with the chemical industry trade association, American Chemistry Council, "to improve testing chemicals for potential human developmental and reproductive effects," according to a NIEHS press release dated 26 July.
ACC will provide $1 million and NIEHS $3 million to a $4 million fund that will support research "on the mechanisms of action of potential developmental toxicants using state-of-the-art tools, including genomics and genetic animal models."
At first blush this sounds great: more money for critical research that will help build scientific understanding of health risks caused by chemical contamination. A closer consideration of the arrangement, however, reveals that its main effect may instead be to undermine the independence and integrity of NIEHS science.
A key flaw it the arrangement is that it places ACC representatives on a panel that will screen research to be funded. According to the press release from NIEHS:
| "Scientists from NIEHS and the Council's LRI will be involved in screening applications for responsiveness to the RFA prior to an independent, NIH scientific peer-review process. Following that process, applications ranked of the highest scientific merit will be offered funding." |
This implies that industry representatives will be directly involved in the selection of proposals to be forwarded to the peer review panels assessing scientific merit.
Note below about clarification from NIEHS dated 31 July 2001.
Predecessors of the ACC have a documented track record of repressing scientific data that threatened their products. There is no assurance that the ACC has changed its patterns of behavior. In fact, in a public debate following airing of Bill Moyers' "Trade Secrets" in March 2001, an ACC spokesperson continued to misrepresent the facts about what was known and not known about chemical threats to health.
While the arrangement calls for peer review of scientific proposals and that "applications ranked of the highest scientific merit will be offered funding," if the selection process has already screened out studies industry doesn't want done, or scientists industry doesn't want involved, then the procees is fundamentally flawed.
If industry-based scientists are also involved in the peer review process, then the program is in double jeopardy. Anyone who has been involved in peer review of proposals know how subtle lobbying can eliminate the most important research under consideration.
Imagine what would have happened to research on the health effects of tobacco smoke if tobacco company scientists were involved in directing federal research and federal funding on health effects.
This MOU is a really good deal for the ACC and a terrible arrangement for independent science. $3 million that NIEHS had to conduct independent research will now be influenced by the priorities of the ACC.
There is a second key flaw in this MOU. Not only does this give ACC inappropriate influence over the direction of research, it also provides them with early warnings on troubling findings in ways that may discourage scientists concerned about the integrity of their work from applying for funding.
To apply for funding from this program requires that applicants explicitly agree that their proposals can be shared with the ACC. According a web-posted description of the program:
| "Because the domestic applications will be co-funded by the National Institutes of Health (NIH) and the American Chemistry Council (ACC), all applicants should submit a brief letter to the NIH indicating that the application and the summary statements for such applications can be shared with the ACC." (emphasis added) |
Scientists regularly put preliminary results into their research proposals. This arrangements creates a real risk that these preliminary results will now flow directly to the ACC and thence to lawyers and PR flacks preparing defences for their products. It may even make it less likely that scientists with challenging findings will seek NIEHS funding, because of fears of abuse of information by ACC.
Participation also requires attending an annual meeting sponsored by ACC and NIEHS (from the web-posted description):
| Upon
initiation of this program, the NIH and the American Chemistry Council
plans to sponsor periodic meetings to encourage exchange of information
among investigators, to foster collaborative efforts among program
grantees, and to identify resources that would enhance the productivity
of grantees. For this purpose, applicants should request travel funds
for a two-day meeting each year, the timing and location of which
will be announced. Applicants should include in their applications
a statement indicating their willingness to participate in such meetings
and, as appropriate, to cooperate with other researchers. |
So not only will ACC and thence ACC member companies learn about research proposals as they are submitted, they will get periodic updates on the progress of research. This puts the fox directly into the chicken coop.
A recent Government Accounting Office report (link to .pdf file) found that industry had too much influence on EPA advisory board decisions. This MOU now threatens the NIEHS with a similar challenge.
Industry should fund this research but the selection of research questions and researchers should be completely insulated from industry biases.
In the NIEHS press release, ACC President Fred Webber commented: "We expect this is the beginning of a long -- and mutually beneficial -- relationship with NIEHS and other federal agencies that also seek synergistic collaborations with industry."
If this is true, it is a serious threat to the integrity of federally-sponsored health research in the United States.
Following significant public interest in the announcement of the NIEHS-ACC agreement, NIEHS issued a clarification:
| This
joint effort maintains the strict independence of the NIH peer review
process in the assignment of a scientific merit evaluation measure
(priority score) for the research grant applications submitted in
response to the request for applications. [Note added: ACC is still
involved in a screening process in which ACC representatives can argue
that proposals don't fit the criteria of the program] The NIH
peer-review process itself is independent even of the NIEHS staff
administering the program and the ACC will have no role in selection
of the peer review group. Neither NIEHS nor ACC staff are allowed
to serve on the peer review panel [What about scientists representing
industry?]. The subsequent second level review by the National
Advisory Council and the funding process is accomplished by the same
procedures used by all NIH institutes, and the funding decisions are
solely made by the NIEHS. The ACC does, however, have the opportunity
to consider applications not selected for funding by the NIEHS for
ACC's own funding... over and above the $1 million they are contributing.
[Guess what they will choose not to fund...] In accord with
the NIH and Public Health Service policies, and other federal regulations,
there is no restriction whatsoever on publishing research findings
from the grants funded by the NIEHS, whatever their outcome. [Note
added: they still have said nothing about the dampening effects of
ACC access to preliminary data on research by independent scientists,
or the requirement that independent scientists present their preliminary
results to ACC representatives. This is a very big issue.]
For additional information please contact NIEHS Division of Extramural Research and Training Director Anne Sassaman, Ph.D., at 919-541-7723; or Michael McClure, Ph.D., DERT, NIEHS at 919-541-5327. |
This clarification offers a welcome perspective on the NIH peer review process. It does nothing, however, to resolve concerns about inappropriate intrusion of the American Chemistry Council into the conduct of NIEHS science. The fox remains in the chicken coop.