Heads They Win, Tails We Lose - How Corporations Corrupt Science at the Public's Expense
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Heads They Win, Tails We Lose How Corporations Corrupt Science at the Public’s Expense The Scientific Integrity Program of the Union of Concerned Scientists February 2012
ii UNION OF CONCERNED SCIENTISTS © 2012 Union of Concerned Scientists The Union of Concerned Scientists (UCS) is the leading science- based nonprofit working for a healthy environment and a safer world. The UCS Scientific Integrity Program mobilizes scientists and citizens alike to defend science from political interference and restore scientific integrity in federal policy making. To learn more, visit www.ucsusa.org/scientific_integrity. The Union of Concerned Scientists is the leading science-based nonprofit working for a healthy environment and a safer world. The full text of this report is available on the UCS website at www.ucsusa.org/scientific_integrity or may be obtained from: UCS Publications Two Brattle Square Cambridge, MA 02138-3780 Or, email pubs@ucsusa.org or call (617) 547-5552.
HEADS THEY WIN, TAILS WE LOSE iii Contents Text Boxes................................................................................................................................................... iv Contributors ............................................................................................................................................. v Acknowledgments .................................................................................................................................. v Executive Summary ................................................................................................................................. 1 Introduction ............................................................................................................................................... 9 Chapter 1: Methods of Abuse ............................................................................................................ 13 Corrupting the Science ................................................................................................................. 13 Shaping Public Perceptions ........................................................................................................... 17 Curbing the Effectiveness of Federal Agencies ...................................................................... 21 Influencing Congress ...................................................................................................................... 26 Exploiting Judicial Pathways ........................................................................................................ 28 Chapter 2: Restoring Scientific Integrity: The First Three Years ............................................ 31 Early Presidential Leadership ........................................................................................................ 31 Protecting Government Scientists ............................................................................................. 32 Making the Government More Transparent and Accountable ........................................ 32 Reforming the Regulatory Process ............................................................................................. 34 Ensuring Robust Scientific Input to Federal Decision Making .......................................... 34 Chapter 3: The Next Four Years ........................................................................................................ 37 Essential Federal Reforms ............................................................................................................. 37 Private-Sector Reforms ................................................................................................................. 45 Conclusion .................................................................................................................................... 45 References ............................................................................................................................................... 47
iv UNION OF CONCERNED SCIENTISTS Text Boxes Ground-Level Ozone ................................................................................................................................ 1 Revolving Door ........................................................................................................................................... 2 Menaflex ...................................................................................................................................................... 3 NOAA ........................................................................................................................................................... 5 Crystalline Silica ....................................................................................................................................... 7 Hog Farm Emissions ............................................................................................................................... 13 Nuclear Waste ........................................................................................................................................ 14 Hexavalent Chromium ........................................................................................................................... 15 Pharmaceutical Ghostwriting ............................................................................................................. 16 Tobacco Health Risks ............................................................................................................................ 17 Vilifying Scientists .................................................................................................................................. 18 Soda and Oral Health ........................................................................................................................... 20 Endangered Species .............................................................................................................................. 21 Childhood Lead Poisoning .................................................................................................................. 23 Gulf Oil Disaster .................................................................................................................................... 24 Coho Salmon ............................................................................................................................................ 25 Oil and Gas Lobbying............................................................................................................................. 26
HEADS THEY WIN, TAILS WE LOSE v Contributors Francesca Grifo is a senior scientist at UCS and director of its Scientific Integrity Program. She holds a Ph.D. in botany from Cornell University. Michael Halpern is the program manager for the UCS Scientific Integrity Program. He holds B.A. degrees in communication studies and sociology from Macalester College. Peter Hansel is an intern for the UCS Scientific Integrity Program. He holds a B.S. in chemistry from Davidson College. Acknowledgments This report was made possible in part by the generous financial support of NoraLee and Jon Sedmak and the Emily Hall Tremaine Foundation. The authors would like to thank David Egilman, Sheldon Krimsky, Sidney Shapiro, Kathleen Rest, Wendy Wagner, and Celia Wexler for their wisdom and helpful comments. The opinions expressed in this report do not necessarily reflect the opinions of the foundations that supported this work, or of the individuals who reviewed and commented on it. Both the opinions and the information contained herein are the sole responsibility of the authors.
HEADS THEY WIN, TAILS WE LOSE 1 E X EC U T IV E S U M M A RY A ccess to the best available science allows challenges. We must have the ability to use indepen- federal decision makers to craft policies dent science to address problems such as the need that protect our health and safety and the for high-quality yet affordable health care, terror- environment. Unfortunately, censorship of scientists ism, climate change, rising demand for energy and and the manipulation, distortion, and suppression of natural resources, population growth, and the loss of scientific information has threatened the federal sci- biodiversity, and to anticipate and tackle challenges entific enterprise in recent years. unknown today. This serious problem has sparked much debate, but few have analyzed the key driver of political interference in federal science: the inappropriate GROUND-LEVEL OZONE influence of companies with a financial stake in the outcome. This influence affects not only the science The Clean Air Act requires the Environmental Protection Agency (EPA) to base standards for used in decision making, but also public opinion certain pollutants, such as ozone, solely on sci- and the decision-making process itself. By better ence. The George W. Bush administration set an understanding how corporations influence the use of ozone standard that was not supported by science, science in federal decision making, we can both hold and President Obama pledged to revisit it. But as companies and policy makers accountable for their the EPA was finalizing its work, top White House actions and ensure that the nation develops science- officials including the White House chief of staff based policies that serve the public interest. met with business groups including the Business The first chapter of this report explores the Roundtable, the U.S. Chamber of Commerce, and numerous methods corporate interests employ to the American Chemistry Council that were opposed inappropriately influence how the federal govern- to a strengthened ozone standard. Subsequently, the ment uses science to make decisions. The second president ordered the EPA to stop its review. chapter provides an overview of the steps the Obama administration has taken to restore scientific integrity to federal policy making. The third chap- ter focuses on the federal reforms still essential to ensure that authoritative and independent scientific information informs policies designed to protect public health and the environment. Recognizing that solving this problem extends far beyond what the government can accomplish alone, we also suggest broader reforms that corporations, the scientific © iStockphoto.com/steinphoto community, academic institutions, news media, and the courts can pursue to ensure transparency and accountability in the use of science. The twenty-first century presents the United States and the world with urgent science-based
2 UNION OF CONCERNED SCIENTISTS Methods of Abuse and exploit executive branch agencies, Congress, and the courts. Corporations attempt to exert influence at every step of the scientific and policy-making processes, often Corrupting the Science to shape decisions in their favor or avoid regulation Corporations that stand to lose from the results of inde- and monitoring of their products and by-products at pendent scientific inquiry have gone to great lengths to the public’s expense. In so doing, they often attempt manipulate and control science and scientists by: to fundamentally alter the decision-making process Terminating and suppressing research. Companies have controlled the dissemination of scientific information by ending or withholding results of REVOLVING DOOR research that they sponsor that would threaten Officials who shuttle between high-level government their bottom line. positions and regulated industries or companies Intimidating or coercing scientists. Corporations undermine the integrity of federal science and public bury scientific information by harassing scientists confidence in government. While sharing expertise and their institutions into silence. Scientists have among different sectors can sometimes be ben- been threatened with litigation and the loss of eficial, there is serious risk that the revolving door their jobs, have had their research defunded, have will allow individuals with clear financial conflicts been refused promotion or tenure, and have been of interest to hold key decision-making positions. transferred to non-research positions, leading to Predictably, revolving-door officials develop or self-censorship and changes in research direction. direct policies that benefit a former or prospective Manipulating study designs and research protocols. employer. The legacy of political appointees with Corporations have employed flawed methodolo- conflicts of interest lives on even after their depar- gies in testing and research—such as by chang- ture—through both the policies they helped develop ing the questions scientists are asking—that are and the erosion of public trust in agency integrity. biased toward predetermined results. Ghostwriting scientific articles. Corporations cor- rupt the integrity of scientific journals by plant- ing ghostwritten articles about their products. Rather than submitting articles directly, compa- nies recruit scientists or contract with research organizations to publish articles that obscure the sponsors’ involvement. Publication bias. Corporations selectively publish positive results while underreporting negative results. While not directly corrupting science itself, these publishing and reporting biases skew the body of evidence. Shaping Public Perception © iStockphoto.com/DNY59 Armed with public relations teams, private interests have launched campaigns that influence public opinion and undermine understanding of scientific consensus. Among their methods:
HEADS THEY WIN, TAILS WE LOSE 3 Downplaying evidence and playing up false uncer- Hindering the regulatory process. Corporations tainty. As scientific understanding of the health advocate for policies that limit the ability of agen- effects of products and substances such as cies to use the best available science when mak- tobacco and particulate emissions emerges, ing decisions. So-called “regulatory reforms” limit companies fight regulation by attacking the sci- agencies’ resources, curb the role of science in ence, downplaying scientific consensus, exagger- decision making, or put an extraordinary burden ating scientific uncertainty and spreading doubt. of proof on agencies before they can act. Vilifying scientists. Scientists analyzing the health and environmental effects of products such as MENAFLEX asbestos and lead, and phenomena such as cli- mate change, are publicly criticized and attacked. New Jersey company ReGen Biologics attempted These attacks and allegations of misconduct dis- to gain Food and Drug Administration (FDA) credit the scientists and deter them from continu- approval for clinical trials of Menaflex, a device it ing their research. developed to replace knee cartilage. After an FDA Promoting experts who undermine the scientific panel rejected the device, the company enlisted consensus. Corporations promote individuals who three members of Congress to influence the overemphasize research that appears to cast evaluation process. In December 2007, Sen. Frank doubt on the scientific consensus. Often their Lautenberg, Sen. Robert Menendez, and Rep. Steve expertise is not in a relevant field, limiting their Rothman wrote to FDA Commissioner Andrew ability to effectively evaluate the scientific find- von Eschenbach asking him to personally look into ings they are criticizing. Menaflex. Soon thereafter, the commissioner met with ReGen executives and heeded the company’s Hiding behind front groups or “capturing” organiza- advice to have Dr. Daniel Shultz, head of the FDA’s tions. Companies use front groups, public rela- medical devices division, oversee a new review. tions firms, and other paid consultants to covertly The FDA fast-tracked and approved the product advance corporate interests while these entities despite serious concerns among scientists. The maintain the illusion of independence. FDA acknowledged its error and revoked approval Influencing the media. Corporations inaccurately in 2010. portray science by feeding the media slanted reports and news stories, or biased spokespeople. Restricting Agency Effectiveness Companies engage in activities that undermine the ability of federal agencies to use independent sci- ence to regulate products. Companies also advocate for more layers of bureaucracy, and take advantage of inappropriate relationships with agency personnel, to hinder the development of policies that protect the public and the environment. © bekathwia/flickr.com Attacking the science. Corporations have attacked the science used to inform federal policy making in an attempt to delay regulation.
4 UNION OF CONCERNED SCIENTISTS Corrupting scientific advisory panels. Government Exploiting Judicial Pathways agencies rely on independent scientific advisory Judges play a growing role in deciding whether panels to provide objective advice. But panel to admit scientific information as evidence, and members often have undisclosed financial con- in ruling on science-based laws and regulations. flicts of interest: ties to companies that stand to Corporate interests have expanded their influence win or lose based on the findings of these advi- on the judicial system, used the courts to undermine sory committees. science, and exploited judicial processes to bully Spinning the revolving door. Officials shuttle and silence scientists. State judicial elections have between high-level government positions become multimillion-dollar campaigns backed by and regulated industries or corporations. This political parties and special-interest groups. revolving door can lead to regulatory capture: federal agencies charged with protecting the Restoring Scientific Integrity: public can end up as shields or advocates for the The First Three Years regulated industries. President Obama is the first president to take on the Censoring scientists and their research. Federal challenge of creating strong federal standards for officials with industry ties have deleted selected scientific integrity and improving scientific advice evidence from scientific documents, knowingly to the government. At the beginning, the president adopted flawed methodologies, put direct pres- signaled that reforms to bolster scientific integrity sure on scientists and their supervisors to alter would be a priority for his administration. In his inau- findings, and censored scientists to prevent them gural address, he pledged to “restore science to its from speaking publicly or with the media. rightful place,” and took several initial steps to make Withholding information from the public. Besides good on that promise. censoring scientists, federal officials acting on The president appointed several top scientists behalf of corporate interests have buried scien- to senior positions in the administration. His science tific findings, delayed the release of information, advisor reports directly to him, unlike the situation or otherwise suppressed or withheld scientific during the George W. Bush administration, when the information. science advisor reported to the White House chief of staff, limiting the science advisor’s access to many Influencing Congress important discussions. The Obama White House The injection of billions of dollars into congressional also issued guidelines directing federal agencies to lobbying and election campaigns compromises the develop and implement scientific integrity policies. will of members of Congress to respond to the needs Some of the resulting policies have spurred signifi- of the people they represent. Money and secrecy in cant, positive steps to ensure that agency decisions lobbying, excessive campaign funding, and a revolv- rest on the best available science. ing door on Capitol Hill give corporate interests A lack of transparency also facilitates political unprecedented and undue access to members of interference in how and on what basis decisions are Congress. This influence encourages members to made, and limits public access to scientists and sci- challenge scientific consensus, delay action on criti- entific resources. Administration officials have taken cal science-based problems, and shape the use of several steps to make the government more trans- science in policy making. A recent marked increase parent and accountable. The White House issued an in lobbying expenditures, along with greatly relaxed Open Government Directive that, while not perfect, rules on corporate spending on elections, has exac- has expanded public access to large amounts of data. erbated these pressures. The White House also began releasing its visitor
HEADS THEY WIN, TAILS WE LOSE 5 logs to allow for more public understanding of who Protecting Government Scientists is influencing decisions, and streamlined the release Scientists and researchers should have the protec- of other government information through Freedom of tions they need to fulfill their public service respon- Information Act requests and other means. sibilities. They should not fear intimidation or face Some agencies have made transparency a pri- litigation for the direction of their research, or for ority. For example, EPA Administrator Lisa Jackson publishing or speaking about their results. issued a “fishbowl” memorandum on her first day on To support this, the administration should the job clarifying that the agency would operate with continue to assert that retaliation against federal full transparency—as if it were a fishbowl. The agen- employees who report political interference in sci- cy made information on the safety of chemicals used ence—such as by reassigning, demoting, or firing and produced by industry more publicly accessible. those scientists—will not be tolerated. Congress Other agencies have improved the ability of their should also pass the strongest possible whistle- scientists to share research results and analysis with blower protection law, and strengthen the federal the public. For example, the National Oceanic and entities that give employees a safe and secure Atmospheric Administration’s (NOAA’s) scientific integrity policy explicitly gives its scientific staff the authority to speak to the media without obtaining NOAA permission from press officers, and reaffirms their right to freely express their personal opinions as pri- The process of developing scientific integrity poli- vate citizens. cies has contributed to positive changes in agency The president reversed a Bush administration culture. For example, NOAA Administrator Jane executive order that had shifted the power to com- Lubchenco encouraged all NOAA employees to mence rule making from agency heads to the White provide input into the agency’s policy. The resulting House. The administration has also fought anti- conversations raised employees’ understanding of regulatory proposals from members of Congress that the importance of scientific integrity in government, would undermine the ability of federal agencies to use and encouraged employees at all levels to take own- science to protect public health and the environment. ership of the final policy. The administration has also strengthened ethics and conflict-of-interest policies for federal employ- ees. Federal political appointees must now submit conflict-of-interest reports and recuse themselves from policy making that affects previous employers. Appointees who are seeking jobs outside govern- ment are also prohibited from working on policies that would benefit a prospective employer. Essential Federal Reforms Despite these steps, further federal commitments to protect science from undue corporate influence are essential. For example, agencies and depart- ments should strengthen and fully implement their scientific integrity policies. The federal government © NOAA should also adopt the following reforms:
6 UNION OF CONCERNED SCIENTISTS means of reporting misconduct and corruption. At branch agency, should be restructured so it can the same time, the National Academy of Sciences better track and enforce ethics standards at should explore appropriate responses for scientists these agencies. and institutions facing harassment or intrusive open- Reforming the Regulatory Process records requests that interfere with their ability to pursue research. The administration and Congress should improve the regulatory process. For example, Congress Making the Government More Transparent and should consult with agencies to remove outdated Accountable or unnecessary procedures to make the regulatory Information created by or submitted to the gov- process and the allocation of resources more effi- ernment should be more transparent. The science cient. Congress should also amend the Paperwork advisor should review agency policies on clearing Reduction Act to allow agencies to better identify official and nonofficial articles, presentations, and and resolve regulatory gaps or inefficiencies, and other information for publication. Agencies that have ensure that agencies have enough resources to not already done so should improve their policies expand oversight and inspection of research facilities to allow scientists to communicate freely with the and contractors. media and the public. The administration should restrict the White Agencies should also reform their criteria House Office of Management and Budget (OMB) for designating data submitted by companies as from interfering in the scientific work of executive “confidential business information,” to make such branch agencies. For its part, the OMB should work data more publicly available, and continue to with federal agencies to make the regulatory process reform classification and declassification processes. more transparent, expand dockets tracking regula- Congress should give agencies sufficient resourc- tions under development, and make the dockets es to respond to open-records and Freedom of more user-friendly. The OMB should issue broad Information Act requests. guidelines on how federal regulators will use cost- The public needs to know who is influenc- benefit analysis. ing federal decisions. Federal agencies should The administration should terminate inappro- follow the lead of the White House and institute priate interagency review of scientific documents. a disclosure policy for meetings with representa- Agencies should disclose more information about tives of outside entities. The administration should who is involved and what scientific documents are create an online database of all federal campaign used in regulatory decisions. contributions, lobbying disclosures, and other To protect the ability of agencies to carry out sci- expenditures that could compromise federal deci- ence-based laws as Congress intended, the president sion making. Congress should require entities with should develop and publicly release criteria for the use tax-exempt status, such as 501(c)(6), to disclose of signing statements, and Congress should scrutinize their membership and funding sources. Congress all signing statements and executive orders for con- should pass a law requiring its members to disclose tent that oversteps the intent of legislation. indirect political contributions, and strengthen Congress and the administration should ensure post-employment rules for members and congres- that potential adverse effects of products are report- sional staff. ed to the federal government, and should create a To strengthen public accountability, federal federal registry of scientific research submitted to agencies should establish clear procedures for agencies, similar to the FDA’s clinical trials registry. addressing and publicly reporting allegations of Agencies should impose penalties or fines when political interference in science. The Office of companies submitting information to the govern- Government Ethics, an independent executive ment miss reporting deadlines.
HEADS THEY WIN, TAILS WE LOSE 7 Strengthening Scientific Advice to the research, or otherwise manipulating scientific infor- Government mation. These institutions should embrace transpar- Congress should improve the Federal Advisory ency by disclosing sources of funding, and avoid Committee Act (FACA) to ensure that FACA rules conflicts of interest. apply to all individuals who substantively influence Inappropriate corporate interference in science such committees, limit conflicts of interest among the extends its tentacles into every aspect of federal sci- members, and improve the disclosure of such con- ence-based policy making. Given the unprecedented flicts. Agencies should track the work of their scien- science-based challenges facing our nation and the tific advisory committees more closely, and meaning- world, federal decision makers must have access to fully respond to their findings and recommendations. the best available science. Addressing this interfer- Congress should create a mechanism that ence will require overcoming high hurdles, but they allows members of Congress to receive timely, pol- are not insurmountable. With strong leadership and icy-relevant, impartial scientific and technological a sustained commitment, both the federal govern- analysis and advice that will help them make ment and the private sector can rise to the challenge. decisions on new initiatives and laws and the alloca- tion of taxpayer dollars. CRYSTALLINE SILICA Federal agencies should set standards for the quality of scientific information submitted by corpo- Crystalline silica, a basic component of many min- rations, trade associations, private research compa- erals, is a serious occupational health hazard that nies, unions, and other institutions. causes an irreversible, progressive lung disease. Strengthening Monitoring and Enforcement After 14 years of analysis, the Occupational Safety and Health Administration (OSHA) submitted Federal agencies should make the scientific informa- a rule to the White House in February 2011 to tion they gather through data collection programs protect workers from silica exposure. The OMB is public, and use it in decision making. required to review proposed rules within 90 days, Congress should investigate how reduced or yet nearly a year later, the White House had failed eliminated funding for monitoring and enforcement to do so, preventing OSHA from even seeking pub- has undermined the integrity of science. lic input on its proposal. In the interim, industry representatives met numerous times with OMB Beyond Government staff about the standard. Corporations, nonprofits, academic institutions, scien- tific societies, and the media also have critical roles to play in reducing abuses of science in federal decision making. As a logical extension of federal scientific integrity policies, private-sector stakeholders who contribute to or influence science used in federal poli- cy making should develop or revisit their own policies regarding scientific integrity, ethics, and misconduct. These institutions should promote honest scientific investigation and open discussion of the © clauderobillard/flickr.com results of such research. These institutions should also refrain from actual or perceived acts of scientific misconduct, such as by suppressing or terminating research, censoring scientists, altering the scope of
HEADS THEY WIN, TAILS WE LOSE 9 I N T RO D U C T ION A strong and sustained federal investment in scientific research has given decision makers the ability to craft public policies that protect our health, safety, and environment. Unfortunately, the censorship of scientists and the manipulation, distortion, and suppression of scien- tific information—driven by both ideology and com- mercial interests—threatens the quality of federal decision making. If left unchecked, inappropriate private-sector influence on science decreases the effectiveness of the federal government, makes it less accountable to citizens, undermines the founda- tions of our democracy, and compromises America’s role as a world leader. Individuals acting on behalf of political, financial, and ideological interests have manipulated federal © The White House science for as long as the challenges facing our country have had strong scientific and technological components. During President Eisenhower’s ten- ure, physicist Robert Oppenheimer was forced out President Obama meets with John Holdren, federal science advisor and of government service because of allegations that director of the Office of Science and Technology Policy. he was a security risk (Bernstein 1990). President Richard Nixon abolished the President’s Scientific The Obama administration has taken meaning- Advisory Committee when it became known that the ful steps to address political interference in science. council opposed missile defense and civilian super- However, the solutions put forward thus far do not sonic transport (Branscomb 2004). fully address the myriad levers corporations use to Nor has political interference in science been rel- exert this interference. egated to one side of the aisle. The Carter administra- This report explores the breadth and depth of tion ended a Department of Energy study projecting corporate influence on the science informing federal energy consumption that undercut its policy agenda, decision making. Drawing on numerous investigations and forced the resignation of the study’s leader and by the Union of Concerned Scientists (UCS) and other the director of the U.S. Geological Survey (Branscomb public-interest groups, the first chapter examines 2004). President Clinton ignored the recommenda- some of the most common methods corporate inter- tions of every scientific and medical organization in ests rely on to inappropriately influence how the the world—from the American Medical Association federal government uses science to make decisions. to the World Health Organization—that has exam- The second chapter gives an overview of steps ined the effectiveness of needle exchange in saving the Obama administration has taken to address the lives of drug addicts, and refused to lift the federal these problems. The third chapter describes the ban on funding (Stolberg 1998). federal reforms still urgently needed to ensure that
10 UNION OF CONCERNED SCIENTISTS reliable scientific information inspires policies History and Context designed to protect public health and the environ- In 2003, more than a dozen senior scientists came ment. Recognizing that solving this problem extends to UCS with a troubling observation: on issues from far beyond what the government can accomplish childhood lead poisoning to air pollution, from cli- alone, this chapter also suggests reforms that mate change to contraception, scientists were being corporations, the scientific community, academic silenced, and science was being suppressed, rewrit- institutions, the media, and the courts can pursue to ten, or misrepresented to support predetermined ensure transparency and integrity in the federal use policy outcomes. UCS launched investigations and of science. compiled case studies where politics had trumped The twenty-first century presents the United science, and the scientists put together a statement States and the world with unprecedented challenges. that called on the Bush administration to restore Federal decision makers must have the ability to use scientific integrity to federal policy making. The accurate scientific information to address problems statement drew an enormous amount of attention such as climate change, rising demand for energy because it was signed by senior scientific advisors to and other resources, population growth, and the loss both Republican and Democratic administrations dat- of biodiversity, and to anticipate and tackle chal- ing back to President Eisenhower. Over time, nearly lenges unknown today. By documenting avenues 15,000 scientists added their names. of inappropriate private-sector influence on federal From 2005 to 2011, UCS conducted surveys science, this report enables policy makers and the and received responses from more than 5,100 sci- public to hold corporations accountable for their entists at nine federal agencies, including the Food actions, and to ensure that independent scientific and Drug Administration (UCS 2010e, 2006), the information fully informs policies designed to protect Environmental Protection Agency (UCS 2008), the the public good. National Oceanic and Atmospheric Administration (UCS 2005), and the Department of Agriculture (UCS 2010e). Among other troubling trends, the Independent scientific information is results revealed that hundreds of scientists across critical to addressing many challenges, the agencies had personally experienced political interference in their work (UCS 2010e, 2009e). such as reducing harmful emissions Scientists attested that the interference often from coal-fired power plants. stemmed from inappropriate corporate influence. © U.S. Department of Energy
HEADS THEY WIN, TAILS WE LOSE 11 Despite significant and sustained pressure from people of all political stripes, the Bush administration continued to politicize science. What was first seen as aberrant behavior was then understood to be more systemic, reinforced by centralized control of the Executive Branch under the theory of the unitary executive. The manifestation of this theory included extensive changes in procedures that limited or elim- inated scientific input into policy making. In late 2007 and early 2008, UCS convened listening sessions with science policy experts, gov- ernment scientists, congressional staff, federal agen- cies officials, whistle-blowers, and representatives of public-interest organizations to explore long-term © NOAA solutions. The resulting report, Federal Science and the Public Good: Securing the Integrity of Science in Scientist and NOAA Administrator Jane Lubchenco helped the agency Policy Making, made specific recommendations for put forward a strong scientific integrity policy. actions the administration, agencies, and Congress could take to restore scientific integrity to federal Administration officials continue to face consid- policy making (Grifo et al. 2008). erable pressure to politicize science—and at times, President Barack Obama initially put reforms they have. During the Deepwater Horizon oil disaster to bolster scientific integrity at the top of his sci- in 2010, NOAA public-affairs officials misrepresented ence agenda, and pledged in his inaugural address scientific analysis of the amount of oil remaining in to “restore science to its rightful place” (Obama the Gulf of Mexico (Froomkin 2010). In September 2009a). The president immediately elevated his sci- 2011, corporate interests factored into the president’s ence advisor to be an assistant to the president, and decision to prohibit the Environmental Protection made several high-profile appointments of individu- Agency (EPA) from issuing standards for ground-level als with excellent scientific credentials to head agen- ozone pollution based on the best available scien- cies. Two months after taking office, the president tific information (Broader 2011). In December 2011, issued a memorandum on scientific integrity, stating, Department of Health and Human Services Secretary “It’s about listening to what our scientists have to Kathleen Sebelius set a dangerous precedent when say, even when it’s inconvenient—especially when she overruled more than a decade of analysis by it’s inconvenient” (Obama 2009b). experts at the Food and Drug Administration (FDA) In December 2010, the White House released for the first time, and ordered the agency to refuse guidelines on scientific integrity, and instructed over-the-counter access to emergency contraception federal agencies to develop specific policies that to all women of childbearing age (Harris 2011). would institutionalize strong standards for scientific These pressures, both financial and ideologi- integrity (Holdren 2010). By the end of 2011, though, cal, are pernicious and lasting. It is time to pursue progress on the policies was uneven. While some a comprehensive vision for reform that will ensure government entities, such as the Department of the scientific integrity in federal decision making. This Interior and the National Oceanic and Atmospheric vision should include not only changes in the culture Administration (NOAA), had finalized and begun to and operation of the federal government, but also implement policies on scientific integrity, many oth- reforms in the private and nongovernmental sectors ers lagged behind (Holdren 2011). that curb abuses of science.
HEADS THEY WIN, TAILS WE LOSE 13 C HAP T ER 1 Methods of Abuse F inancial and ideological interference in sci- Termination and suppression of research. Cor- ence-based public policy in the United States porations have controlled the dissemination of is nearly as old as science-based public policy scientific information by terminating research they itself. However, the problem has become more vis- have commissioned, or suppressing the results, ible and pervasive in recent years. While the Obama when they would threaten corporate investments. administration is taking steps to establish strong • GlaxoSmithKline, a pharmaceutical company scientific integrity standards, financial and ideologi- that manufactures the antidepressant Paxil, com- cal interests continue to exert undue and often inap- missioned five clinical trials from 1998 to 2002 propriate influence over the science used in policy to assess the drug’s efficacy in addressing pedi- making. While ideological pressures are a problem, atric and adolescent depression. The company this report focuses solely on the commercial drivers published the results of only one trial, which behind the politicization of science. were mixed. The other four trials had found Using their vast financial resources, corpora- negative results, including that the drug raised tions attempt to exert influence at every step of both the risk of suicide (McGauran et al. 2010). The the scientific and policy-making processes, often to shape decisions in their favor, or to avoid regulation and monitoring of their products. In so doing they HOG FARM EMISSIONS often attempt to fundamentally alter the decision- Supervisors at the U.S. Department of Agriculture making process. prohibited James Zahn, a research microbiologist This chapter explores this influence, outlining in the department, from publishing or presenting how the private sector corrupts the science used in his research on no fewer than 11 occasions in 2002 policy making, shapes public perceptions, restricts (UCS 2010a). The research showed that emissions agency effectiveness, exploits Congress, and influ- from industrial hog farms contained antibiotic- ences the courts. In short, we document the many resistant bacteria. Zahn’s supervisors censored him methods that companies use to tip the scales in the after receiving questions from a representative of favor of corporate interests, with specific examples pork producers (Kuehn 2004; Beeman 2002). across many decades. Corrupting the Science When funding their own studies, corporations may terminate or fail to report research with negative findings, tailor study designs to lead to desired out- comes, and overreport positive results. Companies may rely on the names of respected academics to publish corporate-funded research. And they may attack scientists whose research proves inconvenient. The following examples stem from litigation or unauthorized leaks. The true extent to which corpo- © USGS rations corrupt science is unknown.
14 UNION OF CONCERNED SCIENTISTS company then hampered FDA efforts to investi- “When things don’t ‘go their way,’ a gate by blocking the agency’s access to data from the clinical trials, citing confidentiality agree- company or its representatives will call ments GlaxoSmithKline scientists had signed and harass office directors to approve (Meier 2004). their product.” • Boots, a pharmaceutical company, commissioned —FDA scientist (UCS 2012) Dr. Betty Dong, a scientist at the University of California–San Francisco, to test the effects of Synthroid, a replacement for thyroid hormone. and their institutions into silence. The coercion Boots hoped to reveal that despite its high price, comes in many forms. Corporations muzzle scien- Synthroid was more effective than similar drugs. tists by including gag orders in research or employ- The company closely monitored the research, ment contracts. Scientists have been threatened with and when Dong found that the drug was no more the loss of their jobs, had their research defunded, effective than its competitors, instructed her been refused promotion or tenure, and been trans- not to publish the results. When she refused to ferred to non-research positions (Kuehn 2005; comply, Boots threatened to sue. The company Martin 1999). Corporations have also used litigation relented only after several years, during which and open-records requests to tie up their time and consumers continued to pay for the costly prod- resources. uct (Altman 1997; King 1996). • A scientist overseeing a clinical trial of the HIV Intimidating or coercing scientists. Corporations drug Remune published an article in the Journal bury scientific information by harassing scientists of the American Medical Association concluding that the drug was ineffective. The pharmaceutical company that developed the drug sued the sci- NUCLEAR WASTE entist in retaliation (McGarity and Wagner 2008; Los Angeles Times 2000). In 1996, a company proposing to build a nuclear • In July 2010, an FDA advisory panel recommended waste facility in Ward Valley, CA, threatened to sue a recall of Avandia, used to treat Type 2 diabetes, two scientists commissioned by the U.S. Department and placed severe restrictions on its availability. of the Interior to investigate the facility’s safety Although this was the last and most stringent step (Kuehn 2004). When the department could not in a series of FDA assessments of the drug’s safe- guarantee that it would protect the scientists, they ty, GlaxoSmithKline, the manufacturer, had long halted their research (Clifford 1996). known about its potential side effects. In 2000, Dr. John Buse at the University of North Carolina © WV Division of Homeland Security and Emergency Management found that Avandia users had a high risk of heart disease, and published his findings. In response, Dr. Buse alleges, a representative from the com- pany contacted his boss, accused him of lying, and threatened to sue him for a $4 billion drop in the company’s stock valuation (Calabresi 2010). Manipulating study designs and research protocols. Rather than relying on standard procedures designed to ensure unbiased research, corporations have employed flawed methodologies
HEADS THEY WIN, TAILS WE LOSE 15 biased toward predetermined results. Altering study naproxen decreased the risk of heart attack by designs or research methods through, for example, 80 percent, disregarding studies that had already changes in sample sizes or control groups can obscure found that it has no significant cardiovascular negative effects and promote desired outcomes. benefits (Michaels 2008; Villalba 2000). Instead • One analyst found that industry-funded stud- Vioxx has been found to significantly increase ies were 88 times more likely to find no health cardiovascular risk, leading Merck to withdraw effects related to secondhand smoke than non- the product from the market in 2004. Patients industry-funded studies (Barnes and Bero 1998). who have taken Vioxx experience complications even years after discontinuing use of the drug • To counter a study that found that formaldehyde (Ross et al. 2010). caused cancer in rats, a formaldehyde company commissioned its own study. That study—which found no association between the chemical and HEXAVALENT CHROMIUM cancer—exposed only one-third the number of rats to formaldehyde for half as long as the origi- Both ingesting and inhaling hexavalent chromium nal study. A formaldehyde association quickly have been found to cause severe health effects, and publicized the results and argued before the the chemical has been linked to several types of can- Consumer Product Safety Commission (CPSC) cer. Despite this, from 1993 through the present day, that they indicated “no chronic health effects chromium industry officials have opposed regulation from exposure to the level of formaldehyde nor- of the compound by the EPA and the Occupational mally encountered in the home” (McGarity and Safety and Health Administration (OSHA). In 2003, Wagner 2008). an industry-funded report used small sample sizes • A marketing team at the pharmaceutical com- and statistical maneuvering to undermine the link pany Merck played a direct role in clinical tri- between hexavalent chromium and cancer. Industry als of rofecoxib, an arthritis drug known by trade groups such as Specialty Steel Industry of the brand name Vioxx. Internal documents, North America cited the study, which they had discovered through litigation, revealed that the commissioned, to counter proposed regulations Merck marketing team had developed a strategy (Michaels, Monforton, and Lurie 2006). As recently called ADVANTAGE (Assessment of Differences as 2010, industry-funded reports concluded that between Vioxx and Naproxen to Ascertain further research was needed to determine whether Gastrointestinal Tolerability and Effectiveness) ingesting hexavalent chromium could be linked to to exaggerate the drug’s positive effects, to cancer (Sass 2010). increase the likelihood of FDA approval (Hill et al. 2008). Under the ADVANTAGE strategy, scien- tists manipulated the trial design by comparing the drug to naproxen, a pain reliever sold under brand names such as Aleve, instead of to a pla- cebo. The scientists wrongfully concluded that “They just take you off the product review entirely if they don’t like your opinion.” © EPA —FDA drug reviewer (UCS 2006)
16 UNION OF CONCERNED SCIENTISTS Ghostwriting scientific articles. Corporations complete with analysis, before the outside aca- corrupt the integrity of scientific journals by demics became involved (Ross et al. 2008). planting ghostwritten articles. Rather than submit- • From 1998 to 2007, Pfizer discreetly facilitated ting articles directly, corporations recruit scien- the publication of 15 case studies, six case reports, tists or contract research organizations to publish and nine letters to the editor to boost off-label articles that obscure the companies’ involvement. use of Neurontin, a drug prescribed to treat sei- Scientists have been compensated $3,000 to zures in people who have epilepsy and nerve pain $5,000 to place their name and title on an article (McGauran et al. 2010). The number of patients and submit it for publication (McGarity and taking the drug rose from 430,000 to 6 million, Wagner 2008). In some cases, these scientists making it one of Pfizer’s most profitable products have had limited involvement in the study design, (Egilman and Druar 2011). An investigation found research, or analysis. that Pfizer had failed to publish negative results, While the exact extent to which ghostwriting selectively reported outcomes, and excluded occurs is difficult to measure, confirmed instances specific patients from analysis (Dickersin 2008). reveal that it is abundant. One analysis found that Pfizer failed to note that the drug increased the articles on 33 of 44 industry-initiated clinical trials risk of suicide (Egilman and Druar 2011). exhibited evidence of ghostwriting (Götzsche et al. 2007). • The Tobacco Institute founded the faux journal Reports on Tobacco and Health Research in 1960 • Litigation revealed that Merck employees wrote to spread uncertainty about the link between 20 articles about Vioxx. Of those, 16 listed an smoking and lung cancer. The journal, circulated external scientist as the primary author, despite to doctors, scientists, and the media, included the fact Merck personnel had drafted the articles, articles such as “Cancer Personality Pattern Is Reported to Begin in Childhood,” “Lung Specialist Cites 28 Reasons for Doubting Cigarette-Cancer PHARMACEUTICAL GHOSTWRITING Link,” “Inhalation Tests Fail to Cause Lung One analysis found ghost-authorship of articles on Cancer; Virus Suggested,” and “Psychological, Avandia, Fen-Phen, menopausal hormone therapy, Familial Factors May Have Roles in Lung Cancer” Neurontin, Paxil, Tylenol, Vagus nerve stimula- (Michaels 2008). In 2003, Merck replicated that tor, Vioxx, Zoloft, and Zyprexa in medical journals strategy, setting up the Australian Journal of Bone (Project on Government Oversight 2011). and Joint Medicine to publish articles sympathetic to Merck products, and distributing it to 20,000 doctors (Krimsky 2009). Publication bias. Corporations selectively pub- lish positive results while underreporting negative results. They have also published duplicate articles, made negative reports harder to locate, and made positive reports more accessible. While not directly corrupting science itself, these publishing and reporting biases skew the body of evidence. • One review found publishing and reporting bias © fairfaxcounty.gov regarding 50 drugs or medical devices used to treat 40 medical conditions. For example, of 74 trials of antidepressants, all 38 with positive
HEADS THEY WIN, TAILS WE LOSE 17 results were published, while 22 of 36 trials with “No experimental evidence exists questionable or negative results were not pub- lished (McGauran et al. 2010). to show that any cigarette smoke • An investigation found that multiple articles constituent is carcinogenic to human on the efficacy of Risperdal, an antipsychotic lung tissue.” medication, were based on limited research. —R.J. Reynolds For instance, the results of one trial appeared in six publications under different authorship • Other top oil companies joined ExxonMobil and (Deyo 2010). the American Petroleum Institute, a trade asso- • Pharmaceutical companies have written and pub- ciation, to form the Global Climate Coalition lished meta-analyses—overviews of results from and the Global Climate Science Team (Shulman, multiple research projects—which are important Abend, and Meyer 2007). These groups inflated in establishing scientific consensus. A study of the debate surrounding uncertainties of climate 691 meta-analyses of anti-hypertension drugs science leading up to the Kyoto climate negotia- found that those produced by individuals with tions in 1998. The Global Climate Science ties to drug companies were significantly more Team developed a communications plan to sup- likely to report results in the companies’ favor. port efforts to prevent the United States from (Yank, Rennie, and Bero 2007). entering into a Kyoto agreement. The plan says that by making the “average citizen understand Shaping Public Perceptions (recognize) uncertainties in climate science,” the companies could “undercut the ‘prevailing Armed with public relations teams, companies scientific wisdom’” on climate change (Shulman, have launched campaigns that influence public Abend, and Meyer 2007). opinion and undermine the scientific consensus. They have done so by developing specific strategies to promote false scientific uncertainty, vilify scien- TOBACCO HEALTH RISKS tists, promote sympathetic experts, and prop up industry-sponsored front groups. In a now-infamous memorandum, a tobacco execu- Downplaying evidence and playing up false tive wrote in 1969 that “Doubt is our product, since uncertainty. As scientific understanding of the nega- it is the best means of competing with the ‘body of tive health effects of products and substances such fact’ that exists in the minds of the general public” as tobacco, lead, and particulate emissions emerge, (Brown & Williamson 1969). companies attack the science and spread doubt about the dangers, undermining regulatory will to protect the public. • In response to evidence that cigarette smoke increased the risk of lung cancer, R.J. Reynolds argued that “statistical studies cannot prove cause-and-effect relationship between two fac- tors,” “mice are not men,” and “no experimental evidence exists to show that any cigarette smoke constituent is carcinogenic to human lung tissue © HUD.gov at the level present in cigarette smoke” (Bohme, Zorabedian, and Egilman 2005).
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