Rescuing Science from Politics: Regulation and the Distortion of Scientific Research

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Overview

Rescuing Science from Politics debuts chapters by the nation's leading academics in law, science, and philosophy who explore ways that the law can be abused by special interests to intrude on the way scientists conduct research. The high stakes and adversarial features of regulation create the worst possible climate for the honest production and use of science especially by those who will ultimately bear the cost of the resulting regulatory standards. Yet an in-depth exploration of the ways in which dominant interest groups distort the available science to support their positions has received little attention in the academic or popular literature. The book begins by establishing non-controversial principles of good scientific practice. These principles then serve as the benchmark against which each chapter author compares how science is misused in a specific regulatory setting and assist in isolating problems in the integration of science by the regulatory process.
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Editorial Reviews

From the Publisher
"These are difficult times for science in the zone where it converges with public policy. . . . [S]cience has been playing a critically important role in several areas that have become important exercises of government responsibility, including, but not limited to environmental quality regulations, litigation over damages associated with the external costs of private activity (toxic torts), and the legal responsibility of manufacturers for product harms. What has happened, in this more political contemporary environment, to science and the people who practice it? That is the subject of this book."
From the Prologue by Dr. Donald Kennedy, Stanford University and Editor of Science

"This compendium by some of the nation's top philosophers and legal scholars provides a chilling portrait of the heavy burdens on the scientific enterprise that have evolved over the past decade. Science remains an exquisitely social institution, with human fragilities, strengths, and follies. The marketplace of ideas is fettered by competing political interests. Democracy rests on an informed public that freely consents to be governed. This book reveals the precarious nature of scientific information on which any democratic society must depend."
Devra Davis, Director, Center for Environmental Oncology, University of Pittsburgh Cancer Institute

"For those who think of science as an honest and objective broker in policy making, this volume paints a very different picture, and it's not pretty. But it's the ugly side of the regulatory process, where scientific research is often distorted to serve questionable ends, that badly needs greater exposure. This book is an eye-opener that not only documents the problems, but also takes great pains to make sensible proposals for reform that merit serious consideration."
Mark S. Frankel, Ph.D., Director, Scientific Freedom, Responsibility & Law Program, American Association for the Advancement of Science

"This book begins with a sobering prologue by Science magazine editor-in-chief and former FDA commissioner Donald Kennedy alerting us to the dangers posed by the increasingly ruthless tactics used by powerful opponents to health and environmental regulations. The book proceeds with detailed example after example showing how opponents to governmental protections have engaged in deliberate and pernicious efforts to subvert the legitimate scientific process for their interest or that of their client and illustrating the Orwellian manner in which the concept of 'sound science' has been corrupted by special interests. This book is a must-read for anyone who cares deeply about science or how it is being both used and abused in public policy."
Michael E. Mann, Director of the Earth System Science Center at Penn State University

"At a time when the United States government is pushing the limits of the law in the interest of risk-producing industries, this book provides a much-needed scholarly analysis of our state of affairs and makes it clear that our policies require recalibration in the interest of public welfare."
New England Journal of Medicine

"This book does an excellent job of flagging the concerns and pointing us in the right direction toward reform."
Jeffrey C. Lerner, Ph.D. Plymouth Meeting, Pennsylvania

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Product Details

  • ISBN-13: 9780521855204
  • Publisher: Cambridge University Press
  • Publication date: 6/30/2006
  • Pages: 328
  • Product dimensions: 5.98 (w) x 8.98 (h) x 1.02 (d)

Meet the Author

Wendy Wagner is the Joe A. Worsham Centennial Professor at the University of Texas School of Law in Austin, Texas. She received a master's degree in environmental studies from the Yale School of Forestry and Environmental Studies, a law degree from Yale Law School, and clerked for the Honorable Judge Albert Engel, Chief Judge of the U.S. Court of Appeals for the 6th Circuit. Before entering academia, Wagner served as an honors attorney with the Environmental Enforcement section of the Environment and Natural Resources Division of the U.S. Department of Justice in Washington D.C. and as the Pollution Control Coordinator in the Office of General Counsel, U.S. Department of Agriculture. Wagner teaches courses in torts, environmental law, and regulation. Her research focuses on the law-science interface in environmental law and her articles have appeared in numerous journals including the Columbia, Cornell, Duke, Illinois, Texas, Wisconsin, and Yale Law Reviews. She is a member scholar of the Center for Progressive Regulation and chair of its Science Issue Group.

Rena Steinzor is the Jacob A. France Research Professor of Law at the University of Maryland School of Law and has a secondary appointment at the University's Medical School. She received her B.A. from the University of Wisconsin and her J.D. from Columbia University. Professor Steinzor joined the faculty in 1994 from the Washington, DC law firm of Spiegel & McDiarmid. Prior to joining the firm, from 1983 to 1987, she was staff counsel to the U.S. House of Representatives' Energy and Commerce Committee Subcommittee with primary jurisdiction over the nation's laws regulating hazardous substances. From 1976 to 1983, Professor Steinzor was an attorney at the Federal Trade Commission serving in a variety of consumer protection positions. She is a founder, as well as a member of the Board and the Executive Committee of the Center for Progressive Reform and the editor of the Center's book, A New Progressive Agenda for Public Health and the Environment. She has written extensively on environmental federalism, alternative designs of regulatory system, and law and science, publishing in the Minnesota Law Review, Harvard Environmental Law Review, Duke Journal of Law & Policy, Yale Journal on Regulation, Environmental Forum, and Environmental Law Review.

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Read an Excerpt


Cambridge University Press
0521855209 - Rescuing science from politics - regulation and the distortion of scientific research - Edited by Wendy Wagner and Rena Steinzor
Excerpt

Introduction

Wendy Wagner, J.D., and Rena Steinzor, J.D.

Scientists under Attack

To the casual observer, scientists might appear to be the most influential group in the United States with respect to public health and environmental policy. Exhortations that we must use “sound science” to make decisions about whether to prevent potential risks are ubiquitous. No less an authority than a Supreme Court justice, as well as a wide range of other decision makers in the legislative, regulatory, and judicial arenas, have urged that scientists be elevated to the pinnacle of power, entrusted by the rest of us with the authority to resolve our most important and complex problems.1 Deference to scientists as the ultimate arbitrators of policy resonates every time Congress debates such controversies, suggesting that lawmakers and those who work to affect their decisions have nothing but respect for the sanctity and wisdom of the scientific process and its results, wherever they may lead us.

   Why, then, do many scientists deployed at the front lines of the most heated disputes – over global warming, mercury in the human food chain, or the safety of antidepressants for adolescents – feelnot like anointed and omniscient saviors, but instead like hunted prey? For all the lip service paid to the naïve but convenient notion that science has all the answers, the moment that researchers announce a discovery that has significant economic implications for industry or some other affected group, scientists in the spotlight quickly learn to run for cover.

   Beset by scientific misconduct allegations or threatened with breach-of-contract lawsuits if research is published over a private sponsor’s objections, more and more scientists are finding themselves struggling to maintain their credibility in a climate designed to deconstruct the smallest details of their research. Studies are not criticized in an effort to advance research to the next stage of the search for truth, but rather are dissected in an effort to discredit both their results and their authors. Some experts are concerned that the severity of these problems could deter the best and the brightest young scientists from entering the very disciplines that have the greatest potential to inform public affairs.2

   These events are disconcerting not just because they frustrate the goal of using reliable science to formulate policy, but because they could undermine scientific integrity, independence, and transparency to the point that we are deprived of the progress that objective science could offer on a wide range of pressing social problems. When scientists cannot control their own research agendas because they are preoccupied with responding to subpoenas and data requests, when private funding comes only with long strings attached, and when scientists are sanctioned for communicating results that do not serve the economic interests of their sponsors, the core values that define science are threatened.

An Overdue Debate

Rescuing Science collects perspectives from academics specializing in science, law, and philosophy on these worrisome developments. In their individual chapters, the authors describe important clashes between science and law with more precision and identify promising pathways toward reform. Since the focus of the book is on identifying problems and suggesting solutions, the authors consciously set out to find examples of how science has been distorted by special interests using legal tools. While subsequent researchers or commentators may ultimately debate the overall significance of these problems, the well-supported accounts provided in this book leave little doubt that the problems exist and that a variety of regulatory and legal pressures are causing unwarranted intrusions on science.

   The book’s collection of individual essays are organized around a set of neutral principles that were crafted in discussions with a wide range of experts on the use of science in policymaking. These principles should be non-controversial throughout the scientific and legal community. If the principles were followed, the threats to scientific integrity and objectivity posed by misuse of legal tools would diminish substantially.

   This effort to document the adverse impacts of the law on science is long overdue. Others, including contributors to this book, have written eloquently and at length about mounting threats to scientific integrity in the area of food and drug safety and efficacy. But scholars have not yet focused on the broader problems that arise from the law’s insensitivity to the basic principles of science, with particular attention to the protection of public health and natural resources. Nor has anyone endeavored to identify reforms that would forestall such interference. This book meets those challenges.

The Pressure on Science

Scientists unfamiliar with the legal system generally assume that the path of their research from the laboratory to policy makers is a straight and uncomplicated one. Research is published in a peer-reviewed journal so that it can be judged on the merits by knowledgeable colleagues. Well-designed studies with original discoveries can then play a significant role in formulating social policy, while studies with evidence of bias or unclear methodology are discounted. Scientists might also expect that when policy makers are confronted with important questions regarding scientific evidence, they will utilize a “weight of the evidence” approach, viewing available data as a composite and reaching conclusions only after considering the strengths and weaknesses of all of the individual pieces of research. After all, judicial, legislative, and regulatory institutions have the same objectives as scientific institutions: improving social welfare. Thus, scientists reason, rational use of research by policy makers is one of the most promising ways to make sure that this overriding objective is achieved.

   Scientists who have been reluctantly drawn out of their laboratories into political or courtroom battles over the last few decades have learned that legal processes are quite different from this idealized view. Rather than incorporating science into policy dispassionately and using research to further a quest for truth, the legal system makes most decisions through an adversarial process driven by affected parties who interpret and re-interpret the science to prove that they should “win.” This method of making decisions is largely alien to scientific practice and counterproductive to the production of reliable research. Over the last three decades, as science has become increasingly influential in the regulation of industry, these adversarial processes have increased and now pose a substantial threat to scientists who work in controversial areas such as climate change, pesticide registration, toxic chemical risk assessments, and the protection of endangered species.3

   Three concurrent developments, in particular, have placed science under intense pressure. The first is the dramatic expansion of the regulatory system, characterized by a growing body of statutory and administrative law, as well as multiple agencies that regulate products, manufacturing processes, and waste disposal activities through thousands of separate requirements. The multiplication of legal requirements reaches nearly every firm in the manufacturing sector, as well as large portions of the service sector. At the same time, regulators look to science for guidance when they make difficult decisions regarding the stringency of public health and environmental protection. The more emphasis that regulators place on science, the greater the affected parties’ incentives to do what they can to control its content and production.

   The second source of pressure is the expansion of liability for damages caused by defective products, including toxic chemicals. The American judiciary has led the world in developing liability principles for products and activities that cause unreasonable or significant harm to society, provoking great concern from the manufacturing sector. It is not uncommon for liability judgments to be in the millions of dollars for a single victim, and the science supporting plaintiffs’ alleged injuries is critical in determining whether they win or lose.

   The third development is the continuing failure of the U.S. government to provide meaningful financial support to public research on health and the environment. Rather than increasing funding as environmental and health sciences grow in importance, public investment in badly needed research has been relatively flat for the past several decades.4 This dearth of research support may be based, at least in part, on the hope that private parties will pick up the slack.5 Yet that expectation overlooks the intrinsic differences in incentives between companies that conduct research to develop new technologies and companies expected to conduct research on the adverse effects of their pollution and products. Pharmaceutical companies, for example, invest heavily in research in the hope of inventing a new miracle drug that will help humanity and earn large returns for investors, but research regarding the effects of industrial activities on public health and natural resources presents quite the opposite equation for most private companies. If the research suggests unexpected harms and other adverse effects, it leads directly to the expenditure – as opposed to the making – of money. In fact, manufacturers understand the significance of science to liability and regulation so well that they may actually resist conducting basic tests on their products or auditing the potential harms caused by their activities. As long as scientific information can be incriminating and lead to costly liability and regulatory requirements, ignorance is bliss.

   While each of the three factors has a powerful effect on science, their synergism can be overwhelming. The Information Age intensifies these effects in ways not imaginable a decade ago. With the invention of the worldwide web, adverse information about a product circulating in commerce travels rapidly, prompting rapid fluctuations in markets and expanding liability for mistakes in amazingly short order.

   Scientific discoveries were the foundation for crushing liability on industries engaged in the manufacture of asbestos, tobacco, beryllium, and a number of pharmaceuticals and medical devices.6 The mere specter of liability leads virtually every industry to scrutinize research that suggests their activities are more hazardous than generally supposed. Because scientific data appear to have gained the legal power of ending businesses and entire manufacturing sectors, isolated pieces of research can attract scrutiny more fierce than most researchers should be expected to withstand.

   Science has also distinguished itself as one of the main drivers of regulatory requirements. Learning of unexpected hazards or the possibility for adverse effects often leads to public demands for changes in regulations that will prevent or mitigate such threats. In the past three decades, certain pesticides, asbestos, polychlorinated biphenyls (PCBs), lead, and other common chemicals have been banned in whole or in part in the United States as a result of research that revealed the significant harm they could cause.

   These trends and their complex interactions have multiplied the opportunities for destructive collisions between the worlds of law and science. Science is used and occasionally misused in making regulatory, legislative, and judicial decisions. Scientists, with little or no preparation and often without their consent, are drawn into combat between warring advocates within the legal system. Too often, these scientists become lightning rods in battles involving clashes between powerful institutions, both public and private.

Clashing Cultures

Underlying these conflicts between science and law are the two very different approaches that each discipline uses to assess the reliability of empirical evidence and establish the “facts.” In contrast to the overriding principles of disinterestedness and collaboration that dominate scientific inquiry, the legal system is founded on the premise that the clash between equally represented disparate interests metes out justice. Lawyers who represent affected parties place a significantly lower value on objectivity than do scientists, and they are focused on winning immediate results rather than engaging in a lengthy quest to discover the true answer.

   Science demands that, to the maximum extent possible, scientists have no stake in the outcome of the research. The law, by contrast, must solicit input from precisely the opposite types of participants – those who are sorely affected, aggrieved, and stand to lose or win from the outcome. Although documented facts and empirical knowledge are generally welcome, the law can proceed on negotiated truths and tentative assumptions as long as the affected parties are all participating vigorously in the process. The primary criterion for evaluating the reliability of the science in court is whether the testimony of the expert survives challenge by the other interested parties in a highly stylized format (for example, cross-examination) before an audience comprised largely of lay people. In the legislative, regulatory, and judicial contexts, if the credibility of participating scientists is abused or impaired along the way, that injury is just another unavoidable byproduct of a vigorous adversarial system. Science is geared to a fundamentally different approach: maintaining colleagiality so that hypotheses can be vetted and new discoveries advanced.

   While it is relatively easy for anyone familiar with both professional disciplines to see and accept these differences, problems arise when scientists are drawn into legal disputes in a way that invades their independence to conduct research. For example, affected parties in legislative, regulatory, and judicial disputes have on occasion commissioned research specifically to produce an outcome that will help them win their fight. Too often, researchers are asked, and even required, to sign contracts that compel them to suppress any findings contrary to the private sponsor’s overall goals. Experts are also hired to engage in the “deconstruction” and “corpuscularization” of adverse research, casting doubt on every aspect of a study’s methodology and findings. Such deconstruction is intended to discredit the research even though many of the methodological choices targeted by the attack may be perfectly acceptable to the broader scientific community.7

   The tobacco industry is the most notorious intruder on the integrity of independent research, but it is by no means alone.8 Virtually every category of stakeholder that participates in vigorous policy contests over public health and environmental protection has engaged in at least one of the underhanded assaults on science detailed in this book. Industry lawyers and trade associations, plaintiffs’ attorneys, public interest groups, and grassroots citizen groups, as well as the scientists they hire to represent them, have distorted science, harassed researchers, or manufactured results.9 Because public interest groups have fewer resources, however, the most accessible and well-documented cases tend to involve industry.

Restoring Scientific Integrity

The increased number of attacks on science and the influence of private sponsorship on research have generated alarm within the scientific community. In their struggle to fend off such intrusions, a number of scientific organizations have developed positions and tools to preserve the independence of science. Biomedical journal editors, for example, now require the disclosure of possible conflicts of interest before allowing scientists to publish scientific findings or serve as peer reviewers in order to ensure that colleagues are alerted to their potential financial biases.10 The Union of Concerned Scientists collected signatures from hundreds of scientists, including dozens of Nobel Prize winners, in protest of the politicized use of science by the Executive Branch.11 Even large, apolitical societies such as the American Association for the Advancement of Science have passed resolutions and filed comments on the increasing problems of biased research and literature reviews that damage scientific credibility.12

   This book reinforces these efforts. As mentioned earlier, we have organized the twelve chapters, this introduction, and the conclusion around a set of fundamental principles of scientific practice. These principles are grounded in the values long assumed to be the bedrock of scientific independence, disinterestedness, and transparency. They help to identify how far the legal system has strayed in its use of science, threatening scientific integrity at its core. We begin and end with these fundamental principles in order to propose a more productive and honest process for incorporating science into policies that protect public health and the environment:

  • Independence: Scientists must be able to conduct research without unjustified restrictions, including undue influence by research sponsors.
  • Transparency: The data and results of research must be communicated honestly and expeditiously to the research community and broader public. Researchers and those using their research must be careful to represent the findings accurately, including the limitations of that research.
  • A Public Infrastructure for Science: Government support of independent research is essential to produce discoveries that benefit the public good. In appropriate circumstances, peer review may serve an important role in assisting the government’s decision making regarding the use and funding of science, but peer review must never be used to censor research.

   These principles, which are specified in more detail in the “Principles of Good Regulatory Science” beginning on the following page, were drafted after extensive discussions among a community of scientists, lawyers, and philosophers, many of whom are authors of the chapters in this book. Yet the general consensus supporting these principles is evident throughout the scientific literature. As we discuss in more detail, sociologists of science and reports produced by scientific communities, especially the National Academy of Sciences and the American Association for the Advancement of Science, confirm that these principles of objectivity, independence, and transparency are cornerstones of high-quality science. Scientists appear committed to these principles not only in their own research, but also in their review of others’ research. They value and nurture honest and open communication about the limitations of research and the underlying data. And they acknowledge the need for public support of important areas of research.

Independence and Freedom

The first principle underscores the widespread view that objectivity and independence are central to the development of high-quality science. The central value of disinterested inquiry runs through all phases of science, from initial funding to final publication decisions.13 Indeed, the very productivity of the scientific enterprise depends, in large part, on the commitment of each researcher to perform studies in a disinterested way. While studies must be replicable, and typically are, precious research resources


Principles for Good Regulatory Science

Scientists must be able to conduct research without unjustified restrictions, including undue influence by research sponsors.

  • Sponsors must never place restrictions or otherwise influence the design or conduct of a study in an attempt to obtain results favorable to their interests.
  • Research must never be suppressed because it produces results that are adverse to a sponsor or other interested party.
  • No publication or summary of research should be influenced – in tone or content – by the sponsoring entity. Scientists must be able to conduct research without unjustified restrictions.
  • If vested interests use the legal system to harass scientists whose research or expert testimony calls into question the safety of their practices or products, the harassers must be held accountable with sanctions and must compensate injured scientists for the resulting interference with their research and damage to their reputations.

Researchers and those using their research must be careful to represent their findings accurately, including the limitations of that research. The data and methods of research that inform regulatory decisions must be communicated honestly and expeditiously to the research community and broader public.

  • Researchers and those using their data must be honest about the limits of the research and remaining uncertainties. If others misrepresent research to suggest an outcome not supported by the study, researchers must correct these misstatements as soon they become aware of them.
  • Research must never be dismissed or excluded because it does not provide a complete answer to a larger policy or science question. Research, by its nature, is incomplete, and to dismiss research because it does not provide a definitive answer could result in the exclusion of valuable science from regulatory decision making.
  • The data underlying a published study, as well as a comprehensive description of the methods, must be available to other scientists and the public at large upon publication of the study or submission of the results to a federal agency, in compliance with prevailing rules for preserving the privacy of human research subjects. Regulatory agencies should rigorously review and challenge exaggerated claims, however, that underlying data must be kept confidential for business and other reasons.

Government support of independent research is essential to produce discoveries that benefit the public good. In appropriate circumstances, peer review may play an important role in assisting the government's decision making regarding the use and funding of science, but peer review must never be used to censor research.

  • Legitimate scientific peer review does not encompass processes that enable outside stakeholders to pressure scientists to change their views in light of an anticipated policy outcome.
  • Peer review should be done by a balanced group of peer reviewers who have no present or past conflicts of interest likely to affect their review and who specialize in the area. Peer reviewers should disclose the limits of their expertise in assessing the research.
  • Entities that select peer reviewers should disclose any financial conflicts of interest and affiliations or perspectives that may influence their choice of reviewers. The selection of reviewers must never be politicized.
  • Much research that benefits the public good does not generate private compensation for its production. Generous public funding of research is essential for advancements in scientific knowledge, especially in areas where there are no private benefits to be gained from the discoveries.
  • All research produced or used by the government should be subject to basic quality assurance/quality control checks, especially if that research is not published or disseminated widely within the scientific community.
  • Public research monies should be allocated in ways that are disinterested and do not reflect a stake in the outcome of the research.

are best used when scientists can build on the objective work of their peers to advance the scientific enterprise rather than dedicate time and energy to replicating suspect results. Individual scientists can be so wedded to this disinterested norm that they refrain from political activity, at least regarding their research, to ensure that their findings are not tainted by the appearance of bias.14 The scientific community embraces the need for objectivity so uniformly that departures from that core value can produce a loss of professional credibility on the part of the researchers who are associated with producing research under significant conflicts of interest. Ultimately, such lapses undermine the scientists’ overall reputation and jeopardize promotions or other career opportunities.





© Cambridge University Press
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Table of Contents

Prologue Donald Kennedy; Introduction: principled science Wendy Wagner and Rena Steinzor; Part I. Freedom and Independence: 1. Defending clean science from dirty attacks Thomas McGarity; 2. Basic science at risk: protecting the independence of research Katherine S. Squibb; 3. Publication bas, data ownership and the funding effect in science: threats to the integrity of biomedical research Sheldon Krimsky; 4. Science and subpoenas: when do the courts become instruments of manipulation? Paul M. Fischer; Part II. Transparency and Honesty: 5. Smothering the future: the data quality act and adaptive governance Donald Hornstein; 6. The dual legacy of Daubert v. Merrell-Dow Pharmaceutical: trading junk science for junk science Carl Cranor; 7. Using science in a political world: the importance of transparency in natural resource regulation Holly Doremus; 8. Two models for scientific transparency in environmental law David Adelman; 9. The transformation of science into law: default reasoning in international trade disputes Vern R. Walker; Part III. Public Infrastructure: 10. Politicizing Peer Review: the scientific perspective David Michaels; 11. Politicizing peer review: the legal perspective Sidney Shapiro; 12: The government role in scientific research John S. Applegate; Part IV. Recommendations and conclusion Wendy Wagner, J.D. and Rena Steinzor, J.D.
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