Philip Morris
Industry - Funded Research and Conflict of Interest: An Analysis of Research Sponsored by the Tobacco Industry Through the Center for Indoor Air Research
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- Bero, L.A.
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- 2050764627/2050765305/P0622 Ciar@ 2050764677/2050764835/Ciar Industry-Funded Res. And Conflict of Inter Est
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- MARG, MARGINALIA
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i4
Industry-Funded Research and Conflict of Interest: An Analysis of Research
Sponsored by the Tobacco Industry through the Center for Indoor Air Research
De
In.stitut
University of Califorzua, o~ ~ __
Deborah E. Barnes
Research Associate
Institute for Health Policy Studies
1388 Sutter Street, 11th floor
San Francisco, CA 94109
phone: 415-476-1061
fax: 415-476-0705
e-mail: barnes@cardio.ucsf.edu
A version of this manuscript is to be published in
the Journal of Health Politics, Policy and Law.
Lisa A. Bero, PhD
Assistant Professor
Institute for Health Policy Studies
1388 Sutter Street, 11th floor
San Fra.ncisco, CA 94109
phone: 415-476-1067
fax: 415-476-0705
e-maiL bero@card.i<).ucsf.edu
.
Industry-Funded Research and Conflict of Interest: An Analysis of Research
Sponsored by the Tobacco Industry through the Center for Indoor Air Research
Deborah E. Barnes, BA
Lnstitute for Health Policy Studies
School of Medicine
University of California, San Francisco
Lisa A. Bero, PhD
Institute for Health Policy Studies
School of Medicine
and
Division of Clinical Pharmacy
School of Pharmacy
University of California, San Francisco
Deborah E. Barnes
Research Associate
In.stitute for Health Policy Studies
1388 Sutter Street, 11th floor
San Francisco, CA 94109
phone: 415-476-1061
fax: 415-476-0705
e-mail: baraes@cardio.ucsf.edu
A version of this manuscript is to be published in
the Journal of Health Politics, Policy and Law.
Lisa A. Bero, PhD
Assistant Professor
Institute for Health Policy Studies
1388 Sutter Street, 11th floor
San Francisco, CA 94109
phone: 415-476-1067
fax: 415-476-0705
e-mail: bero@czsdi,).ucsf.edu
,
~a,~B
Abstract
The Center for Indoor Air Research (CIAR) was created by three United States
tobacco companies in 1988. Its stated mission is to fund high-quality, objective
research related to indoor air, including studies of environmental tobacco smoke
(ETS). CIAR states publicly that it is independent of the industry, and that the
research it funds is unbiased. The purpose of our study was to exan-+Tne the content,
quality and use of research funded by CIAR, to determine whether CIAR is fulfilling
its mission. We found that two-thirds of CIAR's projects were awarded following
peer-review by an independent group of scientists, while one-third underwent a special
review process and were awarded directly by tobacco industry executives. CIAR's
"special-reviewed" projects were more likely than its "peer-reviewed" projects to be
related to ETS; to be awarded to non-academic investigators; to be awarded to
investigators who publish in non-peer-reviewed and symposia publications; and to
support the tobacco industry position that ETS has not been proven harmful to
health. In addition, investigators who received funding for "special-reviewed" projects
were more likely to have testified on the industry's behalf at federal hearings related
to ETS. At least two of CIAR's "special-reviewed" projects appear to have significant
design flaws that would tend to bias their results toward the tobacco industry
position. Our findings suggest that the tobacco industry is funding "special-reviewed"'
projects through CIAR to develop scient,ific data that it can use in legal and legislative
settings. The industry may be funding "peer-reviewed" projects through CIAR to
~
enhance its credibility, to provide good publicity, and to distract attention away from ~
ETS as an indoor air pollutant. ~
.. d9
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01
A version of this manuscript is to be published in 2 ~
the Journal of Health Politics, Policy and Law. ~
Introduction
During the 1980s, scientific evidence began to suggest that passive smoking, as well
as active smoking, was harmful to health. Three studies were published in 1981
suggesting that nonsmokers exposed to environmental tobacco smoke (ETS) had an
increased risk of lung cancer (Garfinkel 1981; Hirayama 1981; Trichopoulos et al.
1981). In 1986, two scientific consensus reports on the harmful effects of exposure to
ETS were published independently by the U.S. Surgeon General and the National
Academy of Sciences (National Academy of Sciences 1986; U.S. Department of
Health and Human Services 1986). And in 1992, the U.S. Environmental Protection
Agency classified ETS as a Group A (known h»man) carcinogen (U.S. Environmental
Protection Agency 1992). These reports have led to increasing restrictions on
smoking indoors in order to minimize exposure of nonsmokers to ETS.
Inn contrast, a study published in 1992 in a peer-reviewed journal concluded
that "... acceptable air quality can be maintained [indoors] with moderate amounts of
smoking (Turner et al. 1992)." This study was funded by the Center for Indoor Air
Research (CIAR), which was created by U.S. tobacco companies in 1988. CIAR's
stated mission is to fund high-quality, objective research related to indoor air,
including studies of environmental tobacco smoke (Center for Indoor Air Research
.
1989). Tobacco companies provide the bulk of funding for CIAR, and tobacco
company executives sit on CIAR's Board of Directors. Both CIAR and the tobacco
industry state that CIAR is an independent organization. In particular, they ~
emphasize that CIAR's projects are funded in a "scientifically rigorous and objective ~
man.ner" based on peer review by a group of independent scientists known as the ~
~
A version of this manuscript is to be published in 3
the Journal of Health Politics, Policy and Law.
I
Science Advisory Board (Center for Indoor Air Research 1994:3). CIAR states that
this peer-review process "ensures that only high quality research ... is recommended
for funding (Center for Indoor Air Research 1994:3)."
Whenever an industry funds research that is directly related to its product,
there is concern that conflict of interest may influence the research in some way
(Bond 1991; Hillman et al. 1991; Blank 1992; Rothman 1993; Chren 1994; Witt and
Gostin 1994). In particular, there is concern that the sponsor may apply overt or
covert pressure on the investigator to produce results that will be favorable (Hillman
et al. 1991). For example, the sponsor could recommend that the investigator employ
a study design that would be more likely to favor its product. Or the sponsor could
encourage a researcher to emphasize certain conclusions in the fi.nal publication of
the data. Even without any sort of external pressure, investigators may feel
consciously or subconsciously compelled to publish findings that are pleasing, or at
least not damaging, to their sponsors (Fi11m n et al. 1991). In particular,
investigators may fear that future funding will be denied if they publish unfavorable
data (Hillman et al. 1991).
Several studies on the effects of industry sponsorship indicate that these
concerns over conflict of interest may be justified. One study showed that research
.
funded by the chemical industry was more likely than government-funded research to
conclude that occupational eL-cposure to chemical agents was not harmful (Swaen and
Meijers 1988). Another study found that research sponsored by the pharmaceutical
industry was more likely than research funded through other sources to favor the new
drug under evaluation (Davidson 1986). Similarly, a third study showed that research
A version of this manuscript is to be published in 4
the Journal of Health Politics, Policy and Law.
sponsored by drug companies almost always concluded that the sponsor's drug was
equivalent or superior to comparison drugs, even when the data did not completely
support this conclusion (Rochon et al. 1994). These studies provide strong evidence
that industry funding may influence the type of research conducted and the
conclusions drawn from the data.
History has also shown that, when scientific findings are particularly
damaging, industry may attempt to conceal, manipulate or deny th3 findings. The
asbestos industry, for example, funded external contract research on the health
effects of asbestos from the 1930s to the 1950s (Lilienfeld 1991). According to
internal memos, these studies suggested that exposure to asbestos could cause
asbestosis and lung cancer. However, the study results were suppressed, and the
industry continued to deny that asbestos was hazardous to health (Lilienfeld 1991).
Similarly, the lead industry has denied or downplayed evidence suggesting that lead in
paint is a common cause of disease in children (Rabin 1989).
The tobacco industry has a history of funding scientific research that it claims
is independent but is actually designed to fulfill the industry's needs (Bero et al.
submitted). In 1954, U.S. tobacco companies created the Tobacco Industry
Research Committee, which was later renamed the Council for Tobacco
,
Research-U.S.A., Inc. (CTR). The industry stated publicly that CTR's purpose was
to fund independent scientific research on the health effects of smoking and that, to
ensure the objectivity of the research, projects would be selected based on peer review
by an independent Science Advisory Board (SAB) (Council for Tobacco Research
1992). However, internal tobacco industry documents have revealed the existence of
A version of this manuscript is to be published in 5
the Journal of Health Politics, Policy and Iaw.
a"special projects" division within CTR (Cipollone v. Liggett Group 1988; Freedman
and Cohen 1993; Bero et al. submitted). Special projects were funded based on the
recommendations of tobacco industry lawyers, rather than the SAB, and were not
peer reviewed prior to funding. The primary purpose of special projects, according to
tobacco industry lawyers, was to develop scientific data that could be used to defend
tobacco companies against litigation (Saroltin 1988; Bero et al. submitted). In
addition, the special projects allowed the industry to cultivate relationships with
scientists who could later be called upon to testify on the industry's behalf (Bero et al.
submitted).
CTR's special projects were often specifically designed to distract attention
away from tobacco as a cause of disease (Bero et al. submitted). For example,
studies were funded to show that poor nutrition, occupation, or genetic predisposition
could cause the diseases attributed to smoking. In addition, the study designs of the
special projects were sometimes altered so they would be more likely to produce
results that would support the tobacco industry position (Bero et al. submitted).
Although the tobacco industry began funding special projects through CTR in 1966,
their existence was not disclosed until 1988, during the trial of Rose Cipollone vs.
Liggett et. al in New Jersey (Cipollone v. Liggett Group 1988).
Given general evidence suggesting that industry sponsorship can impact the
results or conclusions of sponsored research, as well as specific evidence of previous
efforts by the tobacco industry to control the direction of research it funds, we
hypothesized that research funded by the Center for Indoor Air Research might be
affected by conflict of interest. The tobacco industry argues that exposure to ETS is
A version of this manuscript is to be published in 6
the Journal of Health Politics, Policy and Law.
too low to cause any real damage, and that epidemiologic studies on passive smohng
are flawed and do not prove that ETS is harmful (Tobacco Institute 1986). The
industry has an obvious interest in producing scienti$c data to support these
arguments, since policy makers and juries would be more likely to accept the
industry's claims if there were hard data to support them. In fact, a confidential
report prepared by the Roper Organization for the Tobacco Institute in 1978 noted
that the industry's best strategy for countering public concern over passive smoking
was to fund scientific research. The report stated: "The strategic and long run
antidote to the passive smolting issue is, as we see it, developing and widely
publicizing clear-cut, credible, medical evidence that passive smoking is not harmful
to the non-smoker's health (Roper Organization 1978:A-7)."
We therefore hypothesized that, although CIAR claims to be objective and
independent, the tobacco industry might be funding research through CIAR to
support its position that passive smoking has not been proven harmful to health.
The purpose of our study was to analyze the content, quality and use of research
funded by CIAR, in order to determine whether CIAR is funding truly independent
research or whether it is funding research that appears to be motivated by tobacco
industry interests.
CIA.R's Peer-Reviewed and Special-Reviewed Projects
The Center for Indoor Air Research (CL4R) was formed in 1988 by three U.S. tobacco
companies:. Philip Morris U.S.A., RJ. Reynolds Tobacco Company and Lorillard
L1
Corporation (Center for Indoor Air Research 1989). Svenska Tobaks AB., a Swedish V7
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A version of this manuscript is to be published in 7 4A
the Journal of Health Politics, Policy and Law. C!~
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domestic tobacco company, was added to the list of sponsoring members in 1994
(Center for Indoor Air Research 1994). These four tobacco companies are referred to
as CLAR.'s "charter" members. Other companies may participate in CIAR as
"regular" or "associate" members. The primary difference between these types of
memberships is that charter members provide the bulk of funding for CIAR, and that
charter and regular members are represented on the Board of Directors, while
associate members are not (Center for Indoor Air Research 1994). CIARR currently
has two "regular" members: Hoechst Celanese and Mead Paper, its "associate"
members include several paper and packaging companies.
CIAR's mission, as stated in its 1989-90 Research Agenda, is: "To create a
focal point organization of the highest scientific caliber to sponsor and foster quality,
objective research in indoor air issues including environmental tobacco smoke, and to
effectively communicate research findings to the broad scientific community (Center
for Indoor Air Research 1989:1)." This mission statement was modified in 1992 and
no longer includes a specific reference to environmental tobacco smoke (Center for
Indoor Air Research 1992a). According to CIAR., this mission is accomplished
primarily by funding original scientific and technical research related to indoor air.
The peer-review process used to fund CIAR's research projects is described in
.
its Request for Applications (Center for Indoor Air Research 1994). First, the
research agenda is established by the Science Advisory Board (SAB), an independent
group of scientists with ezpertise in indoor air issues. Once the agenda has been
established, CIAR issues a Request for Applications to the scientific community at
large. All-applications are reviewed first by a group of peers, who are selected from a
A version of this manuscript is to be published in 8
the Journal of Health Politics, Policy and Law.
pool of scientists that have volunteered to evaluate CIAR's applications. The SAB
then reviews the applications along with the peer evaluations and makes
recommendations regarding which projects should receive funding. The SAB's
recommendations are subject to final approval by the Board of Directors. CIAR's
peer review process is similar to the grant approval process used by many
foundations.
Although CIAR's publications state that its projects are funded through the
peer review process described above, we have found that some projects are funded
through a specaal review process. CIAR publishes a brochure that lists the projects it
has funded to date (Center for Indoor Air Research 1992b). The projects are
classified as "research," "applied" or "other," but the differences between these
categories are not explained. Through interviews with CIAR staff members, we were
informed that "research" projects are traditional scientific investigations that are
funded through the peer review process described above and in CIAR's publications;
"applied" and "other" projects are more goal-oriented studies that are funded directly
by the Board of Directors, without undergoing peer review (Marquardt, oral
communication, 1993). None of CIAR's publications mention that some of its
projects are funded through a special review process.
.
Because CIAR's "applied" and "other" projects undergo a special review
process, and because we hypothesized that they might be similar to CTR's special
projects, we will refer to them collectively as "special-reviewed" projects throughout
this paper. CIAR's "research" projects will be referred to as "peer-reviewed" projects.
CIAR awarded $11,135,961 for "peer-reviewed" projects and $4,262,168 for "special- ~
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O
Wk.]
A version of this manuscript is to be published in 9 ~
the Journal of Health Politics, Policy and Law. ~
4
