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Protecting Special Interests in the Name of "Good
Science"
Linda Rosenstock, MD, MPH
JAMA. 2006;295:2407-2410.
Without fanfare
or debate, a member of Congress places a rider on the
omnibus appropriations bill enacted at the end of the
Clinton Administration in late 2000.1 A new 2-sentence law,
now known as the Data Quality Act (DQA),2 directs the administration's
Office of Management and Budget (OMB) to provide a potent
mechanism for interested parties to change the way
government agencies review science.3 The full impact of the act is as
yet unknown, but it has already resulted in the
significant delay of the release and use of valid
scientific information. This new tool, to date used
primarily by those who have reason to silence or
politicize objective scientific research, should be cause
for great concern and serious examination.
Focusing on Science as a Strategy to Subvert
Policy
Unlike honest
differences of scientific opinion, threats to science
posed by vested interests—defined as those who for
economic, ideological, political, or other reasons are
committed to a predetermined outcome whatever the
facts—are not new.4-5 As is now well understood and
acknowledged, the tobacco industry waged war in the
mid-20th century on the emerging evidence of its
product's harm. In the modern era, the tobacco industry
has led the way in creating a strategy of subverting
public policy by exploiting and creating scientific
uncertainty rather than engaging head-on the political
and economic aspects of regulatory action and
policy-making. In a 1969 memo, Brown and
Williamson6 discussed the strategy of creating
scientific uncertainly around tobacco's ill effects,
coining the phrase: "Doubt is our product." Three decades
later, Philip Morris played a significant role in
supporting the DQA as part of its strategy to block
actions on environmental tobacco smoke.7
Tobacco and other industry interests—whether coal and
oil industry interests opposed to climate change policy or
asbestos industry interests fighting asbestos
regulation—have learned that both the public and decision
makers have a far greater appetite to forestall action
based on a seeming scientific debate rather than
acknowledge that the science is well settled in the view
of the scientific mainstream. In the last decade, these
efforts framed this discussion by invoking the need to
bolster "good science" to fight against "junk
science"—the latter referring to the mainstream consensus
with which they disagree.8 By so doing, legitimate
domain for debate is shifted away from the political
arena and attention is focused on the science rather the
political side of the crude but useful formula:
science + politics = policy.
Creating uncertainty by undermining science and scientific
processes is not new. Reflections during my tenure as
director of the National Institute for Occupational
Safety and Health (1994-2000) drew attention to the
pattern of these efforts and a call for a more informed
awareness and thoughtful response rather than the
issue-by-issue, substance-by-substance reaction that was
then and still remains so common.9 It is useful to recap the
tactics identified as background for understanding why the
situation has worsened both qualitatively and
quantitatively.
Examples of tactics that might be grouped in the category of
financial influence include influencing or delaying
unwanted research results (eg, through legal arrangements
that pressure individual investigators to withhold
research findings); buying new studies with the goal of
manipulating data to achieve predetermined results (eg,
conducting a parallel study designed to favor a certain
outcome); buying favorable opinions (eg, direct payment
to experts for editorials, opinion articles, and reviews);
and trying to reduce budgets of those agencies that
helped create the science base from which guidelines and
regulatory action would follow (eg, in the mid-1990s,
eliminating the Office of Technology Assessment and
attempting to do the same for the National Institute for
Occupational Safety and Health and the Agency for Health
Care and Policy Research [now the Agency for Healthcare
Research and Quality]).
Another major tactic is to create delay in releasing or
acting on scientific evidence. Examples include
initiating litigation and finding mechanisms for adding
new layers of "peer review" (eg, industry achieving
through congressional appropriations riders in the late
1990s repeated reviews of the same body of ergonomic
literature that had already documented strong evidence of
links between workplace exposure and musculoskeletal
disorders).9 Yet another major tactic
is to target (if not harass) individual investigators
(eg, making allegations of scientific misconduct) and
institutions such as federal agencies.
A composite of many of these approaches is evidenced in the
successful turning back in 2001 of a decade-long effort to
provide a national workplace ergonomic standard. The
initiation of the standard process began in 1990 in the
first Bush Administration. Using a number of the
aforementioned tactics to question the scientific
evidence underlying the proposal, the standard was
repeatedly stalled from 1995 until 1999 and finally
promulgated late in the Clinton Administration.
Ironically, when the new Bush Administration turned back
the standard as one of its earliest acts, the main
rationale was that it had been "rushed through" at the
last minute by its predecessor.9
The DQA and the Politicization of
Science
What is new in the attacks on
science in the last 5 years is the success in securing
and using new tools to magnify or even invent scientific
uncertainty with the consequence of tilting even further
the advantage to vested interests. These successes have
been aided and amplified by the extraordinary shift within
an executive branch playing an active hand in undermining
its own science and scientists.8, 10-11 The catalog of science
"abuses" from the executive branch, as defined by the
statement of the Union for Concerned Scientists that has
been signed by thousands of scientists, including 48
Nobel laureates, 62 National Medal of Science recipients,
and 127 members of the National Academies of Science,
includes numerous detailed examples of suppressing and
distorting research findings at federal agencies (eg, climate
change research and abstinence-only education) and
undermining the quality of the scientific review and
advisory processes (eg, political litmus tests even for
appointments to peer review National Institutes of Health
study section review committees).10 Prior concerns about
vested interests undermining science often called for the
need for federal agencies to ward against these
efforts—but the landscape is transformed when part of
the damage appears to be systematically coming from within
the executive branch itself.
The DQA is a perfect case in point. Added as a rider at the
last moment by Rep Jo Ann Emerson (R-Mo) without prior
hearings or debate, it directed the OMB to develop
policies and procedures for federal agencies for
"ensuring and maximizing the quality, objectivity,
utility and integrity of information."2 The act allows
individuals or interest groups to request correction of
information disseminated by an agency, in essence providing
a formal administrative process for challenging the
quality of the science and the information an agency
uses.
Proponents of the DQA advocate the need for such controls,
arguing their usefulness not only in the regulatory
process but also in preventing what they consider an
effective federal agency tool around the regulatory
process, so-called "regulation by information," often
through use of the Internet.12 The OMB‘s Office of
Information and Regulatory Affairs published preliminary
DQA guidelines in June 2001, drawing the majority of
comments from the scientific and academic community that
in general wanted to limit the scope of the act. This
community raised questions and concerns about the burden
of proof of the correction mechanisms, namely how the
administrative mechanisms would be put into place to
allow affected parties to seek and obtain correction of
information disseminated by federal agencies, and about
reproducibility of data (raising the specter of avoiding
established scientific procedures and creating new high
bars for admissibility of scientific findings), costs,
and enforcement.13
The Association of American Medical Colleges was among the
many organizations raising these concerns, stating it was
"deeply concerned that the proposed guidelines would
impede communication of valid research findings from
scientific and health research and, contrary to federal
intent, actually diminish the quality, objectivity,
utility and integrity of federal information by imposing
inappropriate standards and layers of review that supersede
time-honored processes for scientific review and
validation."14 On January 3, 2002, the
OMB published its final guidelines, summarizing comments
received and providing definitions and mechanisms to
ensure that applicable federal agencies implement data
quality standards and public correction mechanisms for
the information they disseminate.15
Applications of the DQA
On the face of it, ensuring
data quality and objectivity seems reasonable. However,
in practice, the law as interpreted by political
appointees in an administration open to abetting the goal
of thwarting public policy actions aimed at protecting
the environment and the public's health has had
significant although still not fully realized negative
consequences. It can be argued that the existing
regulatory process and oversight of agency performance
provide many avenues for comment and redress of incorrect
or disputed information.9
Although the administration has declined to enumerate the
source of challenges under the act,2 a Washington Post analysis
of government records indicated that in the first 20
months since implementation of the act, it has been used
predominantly by industry.16 Among 39 petitions (excluding
those correcting minor typographical or factual errors),
32 were filed by regulated industries, business or trade
organizations, or their lobbyists.16 Among the 39, 5
resulted in at least some of the changes requested (all
of these filed by industry interests), 5 were denied, 5
were diverted to other forms of redress, and 24 were
pending.
A Web-based review demonstrated that, since this mid-2004
investigative analysis, in just 2 federal agencies alone
(Health and Human Services [HHS] and the Environmental
Protection Agency [EPA]) an additional 28 petitions (11
to HHS and 17 to the EPA) have been submitted, again
mostly from industry and many still active (eg, a reading
of the docket indicates as active 6 of 11 HHS cases and a
number of seemingly final responses from the EPA under
appeal.)17-18
Petitions to date have included the American Chemistry
Council's challenge to data used by the Consumer Product
Safety Commission in its attempt to ban wood treated with
heavy metals and arsenic in playground equipment. Sugar
interests have challenged the Agriculture Department and
the US Food and Drug Administration over dietary
recommendations curtailing sugar intake, and the Salt
Institute and the US Chamber of Commerce challenged the
data on which the National Institutes of Health
recommended reduced salt intake.19 Requests for relatively minor
corrections have been numerous, including the US Chamber
of Commerce's unsuccessful attempt to alter minutes of a
meeting of the Environmental Protection Scientific
Advisory Board.2
One of the first challenges was by the Center for Regulatory
Effectiveness (a strong proponent of the DQA and often
credited with its original authorship)8 and the Kansas Corn Growers
Association over the quality of the science used by the
EPA in its risk assessment of atrazine.20 Atrazine, a widely used
herbicide, has been repeatedly demonstrated to be a
potent endocrine disruptor, causing among other changes
gonadal abnormalities in frogs.21-22 For these reasons,
atrazine will be phased out of use by 2007 in the
European Union. The petition under the act cited a number
of aspects of data quality, including reproducibility,
relying on its own industry-funded studies (faulted by
mainstream scientific opinion and the EPA itself)—studies
that had shown results different from those of
independent scientists, whose work had appeared in
well-respected peer-reviewed journals.
Subsequently, 2 additional petitions have been filed by the
same challengers, including questioning the data quality
underlying the review by the National Toxicology Program
on atrazine's potential carcinogenicity in humans.23 Atrazine is already
classified as an established animal carcinogen and hence
a possible human carcinogen by the International Agency
for Research on Cancer. To date, despite the mounting
scientific evidence, the EPA has yet to restrict
atrazine. The National Toxicology Program's review, which
serves the role of risk characterization only (ie, a
nonregulatory information process, already widely open to
review and comment, that describes risk without judgment
of cost and benefit of use), is still pending. In sum, for
this substance alone, 3 challenges to 2 agencies resulted
in significant delay and possible avoidance of
regulation, not to mention withholding of important and
valid scientific information from the public.
Implications of the DQA
Over the years, vested
interests have had many tools—largely derived from
economic and, in turn political, clout—to undermine
evidence-based public policy. Mechanisms for administrative
review of governmental regulatory and other actions, and
challenge to underlying scientific assumptions, were
quite extensive before the DQA. The act does, however,
make it easier for such challenges, and importantly
provides a mechanism for challenging data and information
far earlier in the continuum of knowledge to action.
One clear intended consequence is to delay the already
lengthy regulatory process. It poses the risk as well of
inhibiting agencies from acting on emerging science. The
DQA is also an unfunded mandate, as agencies with no
added resources are required to undertake new rules and
procedures and respond to requests for corrective
actions, often at significant opportunity not to mention
economic costs. At this time, it is still undetermined
whether the act allows judicial review, for example, of an
agency's response to a data quality challenge.
In a victory for opponents of the DQA, a March 2006 decision
by the US Court of Appeals for the Fourth Circuit upheld a
lower court's ruling denying judicial reviewability of a
data quality decision stemming from a challenge by the
Salt Institute and the US Chamber of Commerce to the
National Heart, Lung, and Blood Institute. Further
judicial tests of the reviewability under DQA are
anticipated. If data quality decisions are determined to
be subject to judicial review, yet another avenue will be
available for using litigation as a major delaying tactic
to forestall public policy.
The act also has been used as a subtext for further
scientific manipulation within government, for example,
the OMB's recent efforts to initiate new peer review
guidelines for federal agencies (among other things, it
would have precluded those federally funded scientists
who are often the most expert but not disallowed those
who are solely industry funded).24 Although this venture
by the OMB set off a firestorm among the scientific and
academic community that resulted in significant revision,
it was the DQA that was cited as the inferred basis for
the OMB venturing so far afield.25
In summary, although much more needs to be learned about the
reach and impact of the DQA, it is already clear that the
act provides an additional powerful weapon in the current
arsenal by which vested interests foster scientific
uncertainty as a socially acceptable means to delay or
block actions intended to protect our environment and
health. Perhaps more worrisome, and as yet unmeasured, is
the degree to which federal agencies, under the burden of
the new law and wary of its use, will simply self-censor
information that, although of the highest quality, is
likely to come under challenge by those who perceive they
will suffer from its dissemination. All this was achieved
by one member of Congress tucking in a few lines of text
in the midnight hour of a large appropriations bill. For
that alone there should be great concern.
AUTHOR INFORMATION
Corresponding Author:
Linda Rosenstock, MD, MPH, UCLA School of Public Health,
650 Charles E. Young Dr, 16-035 CHS, Los Angeles, CA
90095-1772 (lindarosenstock@ph.ucla.edu
).
Financial Disclosures: None reported.
Author
Affiliation: UCLA School of Public Health, Los Angeles, Calif.
REFERENCES
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