Fw: Attacks on Science: The Risks to Evidence-Based Policy

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From: " ilena rose " <ilena@...>

Sent: Saturday, January 26, 2002 8:25 PM

Subject: Attacks on Science: The Risks to Evidence-Based Policy

~~~ Many thanks to Caroline for this valuable article in the American

Journal of Public Health. It fits perfectly with our issue.

http://www.ajph.org/cgi/content/full/92/1/14

EXCERPT:

" TACTICS USED TO UNDERMINE SOUND SCIENCE

A wide array of vested interests-and here we mean those who, for whatever

reason, are committed to a predetermined outcome independent of the

evidence-may drive the undermining of sound science to forestall the policy

implications that would necessarily follow. "

The perfect example of this is Dow's statement made in 1991:

" If Dow Corning was convinced that irrefutable scientific information

about significant adverse effects of the device were known today, there

would be a reason to considerwithdrawing from the market. "

NOTE: Dow left the mammary business less than a year later.

Of note, too, is this comment they made.

" Were we to abdicate there would be no other organization in

the market with the background and capability to provide ongoing

scientific research on the health effects of the device... Or, if another

organization had indicated its competence and commitment to continued

research in the field, that also might give us a reason to withdraw. "

Full text of " WHY DOW CORNING WILL REMAIN IN THE MAMMARY IMPLANT BUSINESS "

at:

http://groups.google.com/groups?hl=en & selm=ilena-1601021813000001%40dt011n65

..san

..rr.com

http://www.ajph.org/cgi/content/full/92/1/14

ETHICS AND PUBLIC HEALTH

Attacks on Science: The Risks to Evidence-Based Policy

Rosenstock, MD, MPH and Lore Lee

Rosenstock is with the School of Public Health, University of

California at Los Angeles. Lore Lee is with the School of Public

Health and Health Services, Washington University, Washington, DC.

Correspondence: Requests for reprints should be sent to Rosenstock,

MD, MPH, School of Public Health, University of California at Los Angeles,

PO Box 951772, Los Angeles, CA 90095-1772 (e-mail:

lindarosenstock@...).

As government agencies, academic centers, and researchers affiliated with

them provide an increasing share of the science base for policy decisions,

they are also subject to efforts to politicize or silence objective

scientific research. Such actions increasingly use sophisticated and

complex strategies that put evidence-based policy making at risk.

To assure the appropriate use of scientific evidence and the protection of

the scientists who provide it, institutions and individuals must grow more

vigilant against these tactics. Maintaining the capacity for evidence-based

policy requires differentiating between honest scientific challenge and

evident vested interest and responding accordingly, building and

diversifying partnerships, assuring the transparency of funding sources,

agreeing on rules for publication, and distinguishing the point where

science ends and policy begins.

AS GOVERNMENT AGENCIES, academic centers, and their researchers

increasingly provide the science base for policy decisions, they are also

subject to forces that seek to politicize or silence objective scientific

research. We refer not to the honest differences and conflicts that arise

in response to scientific uncertainty, but to the pressure to use science

to justify policy (even when the data are inadequate), as well as the

vulnerability of science to attacks driven by vested interests-interests

that exploit scientific uncertainty to deflect attention from what is known

and from the actions that would credibly follow that knowledge.

Attacks on science are not new. Galileo, for example, was charged with

" vehement suspicion of heresy " and put on trial in 1633 when he was 69. To

save his life, Galileo publicly renounced his belief that the sun, not the

earth, was the center of the universe. In 1992, after more than 350 years

had passed, the Vatican deferred to Galileo's scientific theory and granted

him a full pardon.1-3

As attention and respect for scientific research grow, attempts both to

overdetermine scientific findings and to undermine the policy implications

of sound science are becoming increasingly sophisticated and complex,

putting evidence-based policymaking at risk.

The increasingly global economy is influencing investments in research,

scientific publications, and research alliances.4 US health research and

development funding has increasingly shifted from public to private

sources. Between 1965 and 1995, the proportion of health research and

development funded by federal sources dropped by almost half, to 37.4%,

while industry's financial support increased more than 2-fold, to 52% of

the total $35.8 billion expended.5 Nearly 12% ($1.5 billion) of research

funds to academic institutions now come from the corporate sector.6

Universities are also increasingly turning to Congress as a direct source

for research funding; universities and their lobbyists have secured more

than $7 billion since 1980 through congressional earmarks inserted into

spending bills.7

Meanwhile, the public is demonstrating an increasing interest in technology

and health. Developments in medicine and health care outranked moral

values, the stock market, national policies, and television content in a

recent survey of the issues that most affect peoples' lives.8 Approximately

1 in 5 people in the United States consider themselves very well informed

about the use of new inventions and technologies and 40% have a great deal

of confidence in the leadership of the scientific and medical communities,

a level that is far higher than levels reported for the leadership of other

major institutions in society.4 This trust may be at risk, owing to a

number of forces that are arrayed to influence the use of scientific

evidence.

TACTICS USED TO UNDERMINE SOUND SCIENCE TOP

A wide array of vested interests-and here we mean those who, for whatever

reason, are committed to a predetermined outcome independent of the

evidence-may drive the undermining of sound science to forestall the policy

implications that would necessarily follow. These interests, which are

often financial but may also be emotional, ideologic, and political, may be

acting alone or in combination. Although economic interest is a common

motivation and may drive both corporations and individuals (e.g., lawyers,

physicians), emotional interests have played an increasing role in

undermining sound science to achieve their desired ends (as in the case of

victims' groups). The role of corporate interests has been best reported,

at least in part because of the significant economic resources corporations

can bring to bear to influence policy outcomes.

Economic Manipulation

First and foremost, vested interests may use money to inhibit or stall

sound science. The increasing role of industry-sponsored research, despite

its many benefits, also raises concerns. At the extreme are instances in

which an industry sponsors research with the direct goal of countering

existing scientific opinion. Economic interests may adversely affect

scientific integrity through the delaying or withholding of research

results and by directly or indirectly influencing the content of results.

In a survey of more than 3000 scientists in the 50 universities that

received the most National Institutes of Health funding in 1993, 20% of

respondents reported delays of more than 6 months in the publication of

their research results at least once in the previous 3 years to allow for

financial interests, such as patent applications, or to slow the

dissemination of undesired results.9 Another study of corporate investments

in academic research found that donors often expect the right to

prepublication review of research results, ownership of patent rights, and

future consulting relationships.10

Still other studies have found a strong association between authors'

opinions and their financial affiliations. A review of studies on selected

chemicals (alachlor, atrazine, formaldehyde, and perchloroethylene) found

that 60% of studies conducted by nonindustry researchers found these

chemicals hazardous, while only 14% of industry-sponsored studies did so.11

A review of 70 articles about the use of calcium-channel antagonists found

that 96% of the authors supportive of their use had financial relationships

with manufacturers of calcium-channel antagonists, compared with 60% of

neutral authors and 37% of critical authors.12 A study of review articles

on the health effects of passive smoking found that 74% of those who

disclaimed the widely held view of the relationship between health effects

and environmental tobacco smoke had affiliations with the tobacco

industry.13

Federal research is not immune to this type of economic influence, which is

usually brought to bear through congressional channels-often in response to

vested interests-mostly through specific appropriations or barriers to

appropriation. A program or, occasionally, an entire agency may become the

victim of such efforts. The Department of Health and Human Service's Agency

for Health Care Research and Quality, then known as the Agency for Health

Care Policy and Research, was slated for zero funding in fiscal year 1996

after an organization of orthopedic surgeons, angered over the agency's

science-based recommendation of nonsurgical approaches for managing acute

back problems, lobbied Congress.14 Similar efforts were launched by the

same Congress to eliminate or reduce funding for the Centers for Disease

Control and Prevention's National Center for Injury Prevention and Control

and the National Institute for Occupational Safety and Health.15,16

Vested interests also use hired scientists, on a full-time or very

lucrative part-time basis, for special tasks that aim to derail the use of

sound science. Ongoing tobacco lawsuits uncovered a tobacco industry

investment of $156 000 to hire more than a dozen scientists to write

letters and manuscripts discrediting a 1993 federal report that linked

secondhand smoke to lung cancer. These " for hire " materials appeared in the

likes of the Journal of the American Medical Association, the Journal of

the National Cancer Institute, Risk Analysis, the Journal of Regulatory

Toxicology and Pharmacology, and the Wall Street Journal.17 Pharmaceutical

companies have employed similar tactics, paying for favorable articles and

editorials.18

Delay

When economic manipulation fails to influence research, vested interests

turn to a complex arsenal of delaying tactics to forestall the release or

influence of scientific evidence. These tactics include initiating

litigation, fighting for access to raw data, funding parallel studies,

inundating researchers with administrative procedures, and catalyzing

congressional reports or inquiries. One of the favorite delay tactics is

demanding greater or different peer review, such as invoking the Federal

Advisory Committee Act to fault agency approaches to peer review.

A prime example is an ongoing effort to retard work on the development of a

national occupational ergonomics standard. Since fiscal year 1995, the

heavily lobbied Congress had either proposed or passed ergonomics riders to

the Occupational Safety and Health Administration appropriations,

prohibiting or delaying work on development of the standard. In 1998,

Congress also commissioned a National Academy of Sciences study to review,

among other things, a 1997 study released by the National Institute for

Occupational Safety and Health (NIOSH) that found a positive relationship

between specific work activities and the development of musculoskeletal

disorders of the back, neck, and upper extremities.19

Although the National Academy of Sciences study heartily supported NIOSH's

conclusions, in fiscal year 1999 Congress again asked the academy to review

the same issues.20 Not surprisingly, since the large scientific data base

remained the same, the second review corroborated the conclusions of the

first.21 The delay process proved ultimately successful when one of the

first acts of the incoming Bush administration was to withdraw the

long-delayed but just-finalized ergonomics standard that had been

promulgated in the last weeks of the Clinton administration.

Hidden Identities

In attacking science, vested interests may also hide their identities by

masquerading as grassroots coalitions or by affiliating themselves with

neutral organizations. Consider, for example, the National Coalition on

Ergonomics, a research group that opposes a national ergonomics standard;

the Food Chain Coalition, which represents the pesticide industry and works

to prevent regulations; Doctors for Integrity in Research and Public

Policy, physicians who oppose gun control and handgun research; and the

Center for Patient Advocacy, the orthopedic group that lobbied against the

Agency for Health Care Policy and Research's back treatment

recommendations.14,15,22,23 Most recently, what had appeared to be a

grassroots coalition striving to raise awareness about the hepatitis C

virus was actually shown to be a marketing effort run by the pharmaceutical

company Schering-Plough Corp to promote their product, Rebetron, which is

the primary hepatitis C therapy.24

Vested interests have also found ways to infiltrate professional

organizations under the guise of academic neutrality. This can have serious

ramifications for national policy, since the credentials and expertise of

professional organizations give them high credibility. The International

Commission on Occupational Health, which assists in the development of

scientific and policy recommendations, recently fell victim to this

strategy when several members with a vested interest in the asbestos

industry used their affiliation with the commission to develop an

International Labor Organization document that was unusually favorable to

the industry.25,26

Harassment

In their efforts to squelch unwanted scientific findings, vested interests

have also been known to harass investigators, federal agencies, and even

the scientific and policy-making processes themselves.27,28 For example, a

pharmaceutical company, using a variety of approaches, was successful in

delaying for years the publication of research results negative to its

thyroid treatment product.29 A researcher at Toronto's Hospital for Sick

Children was sued by a pharmaceutical company for publishing her negative

conclusions about one of the company's products.30,31 A Brown University

academician and physician became involved in a similar controversy when he

discovered a cluster of cases of interstitial lung disease among workers at

a local textile flocking industry plant.32 The latter incident is

particularly worrisome because the employing institution did not support

the right of a faculty member to publish findings, citing the murky

restrictive covenant that he had signed.33

It is not only commercial interests that have learned the benefits of

harassment. To cite just one example, a group of victims of multiple

chemical sensitivity very publicly attacked the scientific integrity of

authors who published findings that there was no evidence for an

immunologic basis for multiple chemical sensitivity.28

A CASE STUDY OF TACTICS TOP

ABSTRACT

INTRODUCTION

USING SCIENCE FOR POLICY...

TACTICS USED TO UNDERMINE...

A CASE STUDY OF...

RESPONSES TO THREATS TO...

References

A case study that illustrates the majority of the strategies discussed

above involves an epidemiologic study of diesel exhaust and lung cancer,

jointly conducted by NIOSH and the National Cancer Institute. The study is

important not only to the more than 1 million US workers who are regularly

exposed to diesel exhaust, but to the millions of people worldwide,

particularly in the developing world, who are exposed both at work and in

the nonwork environment to diesel exhaust.

After conducting a joint feasibility study, NIOSH and the National Cancer

Institute initiated peer review of the study protocol in 1995. It was not

until 1998, however, that the study actually began. Despite evidence of

diesel exhaust's potential carcinogenicity and a strong study design, the

Methane Awareness Resource Group, a coalition of mine owners and operators

and other industry representatives, initiated litigation in 1996 asserting

that the peer review process violated the Federal Advisory Committee Act.34

When multiple subsequent legal efforts failed to block the study, the group

lobbied Congress to include language in the fiscal year 1998 appropriations

bill that required both agencies to review the issues once more.35

Additionally, there were attempts to insert more peer review, a fight for

access to raw data so that the industry could simultaneously analyze these

data and run its own parallel study, public harassment of the study peer

reviewers, copious Freedom of Information Act requests, and promotion of

congressional inquiries into the most minute details of the study design.

The net result is that an important study with broad occupational and

environmental implications has been delayed by many years. In addition, the

constant need to defend the science and the scientific process resulted in

decreased attention paid to other public health efforts.

RESPONSES TO THREATS TO SCIENCE TOP

ABSTRACT

INTRODUCTION

USING SCIENCE FOR POLICY...

TACTICS USED TO UNDERMINE...

A CASE STUDY OF...

RESPONSES TO THREATS TO...

References

The threats to science are exceedingly complex and intertwined. We propose

that the scientific community increase its awareness of the existence of

these threats and that it mount institutional responses, rather than the

issue-by-issue reactions that are now the norm. It is our hope that the

responses suggested here will generate discussion among universities,

professional societies, government agencies, and individuals about the best

ways to ensure the appropriate use of scientific evidence and the

protection of the scientists who provide it.

First, consider the context and the source of the attack. It is crucial

that we respond appropriately to honest scientific challenges as opposed to

challenges issued by vested interests. We currently tend to react too

defensively to both, and as a result, the economically and politically

powerful can too easily compromise the use of good science. Again, it is

important to recognize that although commercial interests are sometimes the

most obvious sources of attack, others with vested interests (e.g.,

victims' groups and their lawyers) may adopt the same tactics.

Second, the scientific community should build and diversify its

partnerships, especially in controversial areas. Appropriate involvement,

early in the process, of potential critics who are honestly seeking

scientific answers helps forestall later unfair attacks. The field of

occupational safety and health, for example, is now implementing the

National Occupational Research Agenda, an effort launched during a period

of agency vulnerability.36,37 Some of the harshest critics of a federal

role in workplace research are now engaged in guiding and supporting this

effort.38,39

Third, institutions and individuals should strive to ensure the

transparency of funding sources and an appropriate balance of neutral

funding between the public and private sectors. Funding should follow

well-delineated guidelines to protect the integrity of the research

process-particularly important given the wide variability in

conflict-of-interest reporting and policies among the major biomedical

research institutions in the United States.40

Institutions should agree on rules for publication of research results well

in advance to ensure the timely and uninhibited dissemination of scientific

findings. Financial disclosure and recusal requirements should be

universally implemented for peer-reviewed journals and publications, whose

policies currently vary widely. One recent survey showed that only 43% of

medical journals had policies requiring disclosure of conflicts of

interest.41 We should establish additional guidelines to support

investigators' right to publish; bar prohibitions against publication; and

require carefully structured, third-party review for industry-funded

research on industry products.

Professional societies should set limits on the extent and circumstances of

industry sponsorship and should raise awareness of the scope and magnitude

of threats to science. Individuals should increase their vigilance about

accepting gifts, speaking fees, and travel; should be clear about implicit

or explicit expectations of private sponsors; and should be careful to

ensure that any signed agreements conform with basic institutional

requirements for reporting, disclosure, and conflicts of interest.

Fourth, and perhaps most important, we must be on guard to distinguish the

point where science ends and policy-making begins. Consider, for example,

the 1998 White House decision not to fund needle exchange programs and the

1997 National Institutes of Health decision regarding breast cancer

screening. In the case of the needle exchange programs, although emotional

and ideologic vested interests had worked successfully to undermine the

scientific database, the cumulative evidence was clear in finding that such

programs do not increase drug use and do reduce cases of HIV.42 The

administration recognized the science but nonetheless refused to lift a ban

on federal funding of needle exchange programs.43,44 Thus, policy was

driven by political factors, not scientific ones, and the distinction was

clearly acknowledged-no attempt was made to hide the decision behind the

caveat of scientific uncertainty.

Compare this episode with the development of breast cancer screening

guidelines. A National Cancer Institute consensus panel concluded that the

science was inadequate to support routine screening of women aged 40 to 49

years.45 Yet, in response to external pressure from a variety of

vested-interest groups with financial and emotional commitments to

screening, the science was revisited and repackaged, resulting in the

recommendation that women in their 40s be screened every 1 to 2 years.46

Both of these examples involve a variety of complex issues, but the bottom

line of both is the same: there is a need to more rigorously define and

clarify the boundary between science and policy.

Taking steps to protect ourselves against threats to science requires

effort, and it would be naïve to assume that science can ever be truly free

of vested interests and influences. But it is clear that if we fail to act,

we lose an opportunity to strengthen the credibility of scientific evidence

in policy-making and to protect scientific researchers and research. The

ability to maintain the capacity for evidence-based policy is vitally

important to our society.

Acknowledgments

The authors would like to thank Dr Jo Ivey Boufford for her critical review

of and comments on an earlier version of this commentary.

Footnotes

L. Rosenstock conceptualized the main points and wrote the paper. L. J. Lee

provided background research and contributed to the writing of the paper.

Peer Reviewed

Accepted for publication August 27, 2001.

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