Document 06r1q9GRVXJdek6ywKzYbby2V
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influence public opinion by ridiculing scien tists whose research threatens powerful inter ests, irrespective of the quality of those scien tists' research. Advocates for this perspective allege that many of the scientific studies (and even scientific methods) used in the regula tory and legal arenas are fundamentally flawed, contradictory, or incomplete, asserting it wrong or premature to regulate the expo sure in question or to compensate the worker or community resident who may have been made sick by the exposure.
Scientific uncertainty is inevitable in de signing disease prevention programs. Scien tists cannot feed toxic chemicals to people, for example, to see what dose causes cancer; instead, we study the effects on laboratory an imals, and we harness the "natural experi ments" where human exposures have already happened. Both epidemiologic and laboratory studies have many uncertainties, and scien tists must extrapolate from study-specific evi dence to make causal inferences and recom mend protective measures. Absolute certainty is rarely an option.
By magnifying and exploiting these uncer tainties, polluters and manufacturers of dan gerous products have been remarkably suc cessful in delaying, often for decades, regulations and other measures designed to protect the health and safety of individuals and communities.
This strategy, which began as a public re lations tool, is now applied in the legal and regulatory arenas, constraining the ability of the judicial and regulatory systems to ad dress issues of public health and victim com pensation. The US Supreme Court's 1993 Daubert v Merrell Dow Pharmaceuticals, Inc26decision has enabled manufacturers of products alleged to have caused harm to ex clude credible science and scientists from court cases.27 Similarly, the Data Quality Act28 provides a mechanism for parties to magnify differences between scientists in order to avoid regulation and victim compensation.
Our objective is to examine the historical development and current applications of the "manufacturing uncertainty" and "junk sci ence" strategies, considering their relationship to what might be best labeled as the public health paradigm. Preventing disease and pro moting health are the fundamental goals of
public health; the public health paradigm as serts that actions taken to protect the public must be based on the best evidence currently available. The public health paradigm runs head-on into these orchestrated campaigns to manufacture uncertainty, pitting advocates for safety and health protections who acknowl edge scientific uncertainty against opponents who capitalize on the unknown to avert pro tective action.
THE TOBACCO INDUSTRY: "DOUBT IS OUR PRODUCT"
Perhaps no industry has employed the strategy of promoting doubt and uncertainty more effectively for a longer period than has the tobacco industry. For almost half a cen tury, the tobacco companies hired scientists to dispute first, that smokers were at greater risk of dying of lung cancer; second, the role of tobacco use in heart disease and other ill nesses; and finally, the evidence that environ mental tobacco smoke increased disease risk in nonsmokers. In each case, the scientific community eventually reached the consensus that tobacco smoke caused these conditions.29-31 Despite the overwhelming scientific evidence and the smoking-related deaths of millions of smokers, the tobacco industry was able to wage a campaign that successfully delayed regulation and victim compensation for decades.32-34
Following a strategic plan developed in the mid-1950s by Hill and Knowlton (H&K), the tobacco industry hired scientists and commis sioned research to challenge the growing sci entific consensus linking cigarette smoking and severe health effects. Initially, H&K was engaged to minimize the public impact of an American Cancer Society report linking to bacco with lung cancer. On the advice of H&K's experts, the tobacco industry empha sized three basic points: "That cause-andeffect relationships have not been established in any way; that statistical data do not pro vide the answers; and that much more re search is needed."35
The tobacco industry's goal was to pro mote scientific uncertainty. In one confiden tial memorandum, H&K consultants boasted that after 5V2 years of effort, they success fully created "an awareness of the doubts and
uncertainties about the cigarette charges." H&K credited tobacco-funded research that "forced a recognition that the cigarette the ory of lung cancer causation is not estab lished scientifically" and "raised many cogent questions concerning the validity of the ciga rette theory."36
The tobacco industry recognized the value of magnifying the debate in the scientific community on the cause-and-effect relation ship between smoking and lung cancer. In the 1960s, the Tobacco Institute published a jour nal entitled Tobacco and Health Research, aimed at physicians and scientists. The crite ria for publishing articles in the journal were straightforward: "The most important type of story is that which casts doubt on the causeand-effect theory of disease and smoking." In order to ensure that the message was clearly communicated, the PR firm advised that headlines "should strongly call out the point-- Controversy! Contradiction! Other Factors! Unknowns!"37
The same message was communicated to the public. According to one tobacco industry executive: "Doubt is our product since it is the best means of competing with the `body of fact' that exists in the minds of the general public. It is also the means of establishing a controversy (emphasis added)."38
The boldness and success of this campaign, together with the almost unimaginable human toll associated with cigarette smoking, have resulted in the tobacco industry being labeled in the public consciousness as a uniquely nefarious, if not criminal, enterprise. (Just as there had been dispute over the sci entific evidence, the tobacco industry now promotes an alternative interpretation of the history of this dispute. Historian Robert Proc tor has reported that the industry has re tained several historians who testify in court cases that "everyone has always known that cigarettes were dangerous, and that even after 1964 there was still `room for responsible dis agreement' with the US Surgeon General's conclusion that year that tobacco was a major cause of death and injury.")39 But the tobacco industry is not alone; manufacturing uncer tainty and creating doubt about scientific evi dence is ubiquitous in the organized opposi tion to the government's attempts to regulate health hazards.
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DENYING THE EVIDENCE IN THE PRE-REGULATORY ERA
Starting in the earliest years of the 20th century, there were a series of episodes in which industries, facing allegations that their products might be harmful to human health, attempted to dispute the science on which the health concerns were based. Industries that produced hazardous products reacted by reassuring the public of the products' safety; they accomplished this by attacking the stud ies that suggested users could be harmed by these products.40,41
The Lead Industry Gerald Markowitz and David Rosner 42,43
and Christian Warren44 have recounted ef forts by the lead industry to mislead decision makers and the public in order to protect their ability to sell leaded paint and leaded gasoline. These public health historians note that early in the 1900s, lead was well known as an occupational hazard and several Euro pean countries had already banned the use of white lead as an ingredient in interior paint. In the United States, however, when cases of lead poisoning in workers appeared in the 1920s, the industry masterfully refocused at tention from the poisoned workers and em phasized that many other lead-exposed work ers, such as chauffeurs, did not show adverse health effects.42 They shifted the blame from the lead itself and the manufacturing process, and claimed that the workers had sloppy hab its and were careless. By the 1930s and 1940s, when articles reporting cases of leadpoisoned children were published in medical journals, the industry rejected the claims and defended their products again by shifting blame, this time to the poisoned children who "were sub-normal to begin with."42
The Chemical Industry The chemical industry became alarmed in
the early 1950s when a well-publicized con gressional investigation fed the public's con cern about carcinogens in the food supply. Congressman James J. Delaney's House Select Committee to Investigate the Use of Chemi cals in Foods and Cosmetics conducted a twoyear inquiry into the "nature, extent and ef fect of the use of chemicals" in food. The
committee heard testimony about the pres ence of chemicals used in food that had been shown to be carcinogenic in animals.45 The Manufacturing Chemists' Association (MCA) feared that to allay the public's growing con cern about food additives and pesticides, Con gress might force the industry to test chemi cals that were added to or contaminated food.46 In response, the MCA hired H&K in 1951; John W. Hill personally attended the monthly MCA directors' meetings and helped plan the MCA's response to Delaney.47 For the most part, the MCA public relations effort was successful. Congress did not pass legisla tion mandating testing, although weaker legis lation was enacted enabling the FDA to begin to regulate chemicals in the food supply. Rep. Delaney was able to insert the prohibition of the inclusion of any cancer-causing chemical in food, known as the "Delaney clause," in a later piece of food safety legislation enacted in 1958.45 Having developed a program to defend the presence of chemicals in the food supply, H&K was well positioned to design the campaign to convince the world that ciga rette smoking was not dangerous.48
The Asbestos Industry Starting in the first decades of the 20th cen
tury, there were numerous indicators that as bestos was a potent cause of lung disease and cancer. Barry Castleman,49 Paul Brodeur,50 and others5152 have documented the asbestos industry's activities to prevent information about the risks associated with asbestos expo sure from reaching the scientific literature and the popular press.
In the face of a massive epidemic, the in dustry questioned and distorted the science. In 1967, Johns-Manville, the largest North American asbestos producer, retained H&K, which recommended that the industry form the Asbestos Information Association (AIA); the co-director of H&K's Division of Scientific, Technical, and Environmental Affairs served as the AIA's first full-time executive director. The strategy developed by the public rela tions firm was for the asbestos industry "to admit to the hazards of asbestos where they are demonstrable, (emphasis added) publicize efforts of the industry to identify and control asbestos hazards, and, finally, to combat the often hysterical charges of some groups con
cerning hazards of infinitesimal amounts of asbestos in the environment."53
THE REGULATORY STATE AND THE GROWTH OF MANUFACTURED UNCERTAINTY
The early 1970s ushered in the modern regulatory state in the United States. Agencies known by acronyms (e.g., EPA, OSHA, MSHA, CPSC, NHTSA) were created with the goals of protecting the environment and the public's health and safety.54 The sophistication of the regulated industries has grown along with the development of the regulatory apparatus.
Opponents of proposed regulation relied (and continue to rely) on a menu of themes about the underlying science. Employers fac ing regulation by the Occupational Safety and Health Administration (OSHA) often claimed that because they had not documented an el evated rate of disease among their own em ployees exposed to a particular substance, that substance did not require stronger regu lation. These claims were generally made in the absence of an epidemiologic investigation capable of detecting all but the most over whelming exposure-disease relationship. Op ponents of regulation made other arguments as well: the human data are not representa tive, the animal data are not relevant, or the exposure data are incomplete or not reliable. These assertions were often accompanied by the declaration that more research is needed before protective action is justified.
Bladder Carcinogens In January 1973, the Oil, Chemical, and
Atomic Workers (OCAW) union and the Health Research Group (HRG) petitioned OSHA for an emergency temporary standard to prevent workers' exposure to numerous carcinogens. According to the OSH Act, the secretary of labor may issue an emergency temporary standard when he or she deter mines that employees are exposed to a "grave danger." OSHA responded to the OCAW and HRG petition on May 3, 1973, by issuing an emergency temporary standard.
Several of the carcinogens addressed by OSHA's emergency temporary standard were aromatic amines, chemical building blocks necessary to produce many commercially
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important dyes. Decades earlier, scientists had identified several of these aromatic amines, including benzidine and beta-naphthylamine, as potent bladder carcinogens.55'56 In fact, when OSHA later published its final carcino gens rule (in January 1974), the agency noted "the Benzidine Task Force of the Synthetic Organic Chemical Manufacturers Association (SOCMA) does not oppose OSHA consider ing benzidine as carcinogenic to humans."57 There was little disagreement from manufac turers as to the carcinogenicity of benzidine; that debate had concluded decades earlier.
Indeed, SOCMA and other opponents of OSHA's plan to regulate benzidine acknowl edged that the chemical caused bladder can cer in humans. To justify their opposition to OSHA's rule, SOCMA asserted that although workers had been exposed to dangerous lev els of benzidine, current workplace condi tions were much improved and did not pose a risk to workers. In their testimony to OSHA they reported: "All of the reported in stances of bladder tumors in benzidine work ers of which we are aware involve employees who were exposed to benzidine before the improved production and use procedures were adopted."58
Another substance included in OSHA's car cinogens rulemaking was dichlorobenzidine (DCB), a chemical structurally similar to ben zidine. The manufacturers of DCB strongly opposed regulating DCB as a carcinogen, as serting in June 1973 that it "is not a known human carcinogen and that there is quite good evidence to show affirmatively that it is not carcinogenic to man."59 The manufac turer's trade association DCB subcommittee told OSHA "not a single case [emphasis in original] of cancer or other serious illness can be attributed to its use."60 By then, however, there were already several studies in the sci entific literature demonstrating the ability of DCB to cause cancer in animals.61 Six months earlier, a team of scientists sent by the Na tional Institute for Occupational Safety and Health (NIOSH) conducted a field survey of Allied Chemical's Buffalo, NY, facility where both benzidine and DCB were manufactured. NIOSH found that while rigorous controls were in place to control benzidine exposure, the same was not true for DCB. The manu facturers' position was that there was "good
evidence" that DCB was not a human car cinogen; in contrast, NIOSH researchers noted that the manufacturers' evidence was merely based on claims that they have "never seen a case" of human bladder cancer caused by dichlorobenzidine, and ignored evidence suggesting that DCB was a potent animal carcinogen.62
Around the same period, the Upjohn Com pany also manufactured DCB at its North Haven, Conn, plant; Upjohn had switched from benzidine to DCB production there in the mid-1960s. Like Allied Chemical, Upjohn opposed the proposed OSHA standard, as serting that the cases of bladder cancer at its plant among workers exposed to both benzi dine and DCB "were probably attributable to benzidine."63 Not acknowledged were the ob vious limits to that opinion: Upjohn workers had not been exposed to DCB long enough for it alone to have caused a recognizable in crease in the incidence of bladder cancer at the facility. By 1985, however, cancer cases started appearing in workers who were first employed at the plant after benzidine was phased out. A study conducted in 1995 found an eight-fold excess risk of bladder cancer among workers who began work at that facility after exposure to benzidine stopped.64
Another substance OSHA planned to ad dress with its carcinogens regulation was 4,4 methlyene-bis (2-chloroaniline), referred to as MOCA or MBOCA. The primary scientific evidence on which OSHA relied to justify its proposed action came from studies using lab oratory animals. The opposition to OSHA's rule for this substance was fierce, with oppo nents asserting that OSHA's decision to rely on data from animal studies was "illogical."65 The Polyurethane Manufacturers Association asserted that "no epidemiological or clinical evidence exists to even hint at carcinogenicity in humans even though studies have been undertaken covering in excess of 18 years of human exposure to MOCA at the DuPont Company."66
OSHA's proposed MOCA standard was never promulgated, and the two US produc ers of MOCA ceased manufacturing the chemical by 1980. NIOSH researchers later conducted a screening program at one of the facilities reporting that three employees,
among 385 screened, were found to have tumors of the bladder. Two of the men were nonsmokers under age 30 and were first ex posed to MOCA 8 and 11 years, respectively, before the cancers were diagnosed.67
Vinyl Chloride In early 1974, the plastics industry was in
crisis. A B. F. Goodrich physician in Louisville, Ky, reported four cases of angiosarcoma of the liver among workers at one factory producing vinyl chloride monomer (VCM) for production of polyvinyl chloride (PVC), one of the indus try's most important products. This type of cancer is exceedingly rare in humans, and the report of four cases in one facility was suffi cient to cause alarm.68 Federal scientists mounted epidemiological investigations imme diately after the B. F. Goodrich report. Dozens of workers in other VCM/PVC facilities were found with this rare form of liver cancer 69-72 and epidemiological studies also suggested that VCM/PVC workers were at greater risk of developing brain cancer.73
But the crisis facing the plastics industry was heightened by what was occurring in a research laboratory. Angiosarcomas were being detected in laboratory animals ex posed to levels of VCM below the OSHA standard in effect at the time, and the manu facturers had intentionally concealed this in formation from federal regulators.42 Since relatively low levels of VCM exposure had been implicated in cancer causation, and there was no known safe level of exposure, OSHA proposed a new VCM standard of "no detectable level."74
The Society for Plastics Industry (SPI) did what many industries do when they find out that one of their most important products was a carcinogen: it hired a public relations firm. H&K was brought in to help the industry pre pare for OSHA's public hearings and to assist SPI in convincing OSHA to accept a more re laxed standard.
H&K's advice was consistent with the guid ance they offered to other corporate clients faced with damning scientific evidence about the hazards of their products. SPI promoted an alternative exposure level, one that was less stringent than the one OSHA had proposed. To manufacture the appearance that SPI's recommendation was science-based, the public
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various published studies with inconsistent or even contradictory findings.
The success of the junk science movement can be seen in its two primary institutional manifestations: the Daubert26 decision and the Data Quality Act.28 Both of these are structured to force the piece-by-piece exami nation of scientific evidence, in contrast to the weight-of-the-evidence approach used by most scientists in reaching conclusions in the face of uncertainty.
The Daubert Decision In June 1993, the US Supreme Court is
sued a ruling in Daubert v Merrell Dow Phar maceuticals, Inc, requiring federal judges to serve as scientific gatekeepers, allowing into evidence only expert testimony that they deem relevant and reliable.26 A recent analy sis found that judges are requiring physicians who testify as experts to apply standards of causal inference that exceed those which physicians use to diagnose and treat their own patients.86
The effects of the Daubert decision on liti gation that alleges harm from hazardous products can be seen in several cases involv ing Parlodel, a drug used through the early 1990s to stop postpartum lactation. Until it was withdrawn from the market, a number of young women who had been prescribed Parlodel had severe circulatory system epi sodes (including heart attacks and strokes) shortly after taking the drug. On the basis of case reports and animal studies, and the fact that Parlodel can cause a rapid rise in blood pressure in humans, the US Food and Drug Administration (FDA) in 1985 requested that the drug's manufacturer include warnings about hypertension, seizure, and stroke in the drug's labeling. The evidence continued to ac cumulate; the FDA's concern was so great that in 1994, it requested that Parlodel's manufacturer stop selling the drug to lactating women.87
Yet when several women sued the drug's manufacturers, claiming Parlodel was re sponsible for their illness, their cases were essentially thrown out of court for lack of scientific certainty. Judges in several jurisdic tions refused to allow jurors to consider the testimony of scientists or physicians who agreed with the FDA that, on the basis of
case reports, animal studies, and the way the drug works in the body, Parlodel could cause circulatory disorders. Applying the Daubert rule, the judges demanded a level of certainty that was virtually impossible to provide.86
For more than 10 years, Daubert has been the law of the land. Scholars and other au thors have written on its impact and used ac tual judicial decisions to illustrate the discon nect between legal proof and scientific evidence.88-92 Few authors, however, have explored the organized movement to extend Daubert's reach from the judiciary into the executive branch, in particular, into the fed eral rulemaking arena.
Emboldened by the success of Daubert in limiting the use of scientific evidence in the courts, antiregulatory interests are promoting the application of Daubert principles in judi cial review of federal regulation.93-96 Most notably, Daubert is prominently featured in the official position on scientific information in federal rulemaking of the US Chamber of Commerce:
The same standards of relevance and reliability that safeguard the rights of litigants in federal courts should safeguard the public interest in the regulatory process. Regulations affecting business and the public should have a scien tific, not political, foundation. That's why we advocate the adoption of an Executive Order requiring all federal agencies to apply the Daubert standards in the administrative rule making process.97
Proponents of public health protections, especially those advanced in the face of sci entific uncertainty, should be wary of calls to extend Daubert to the regulatory arena. The legal, economic, and political obstacles faced by regulators will increase dramatically when Daubert-like criteria are applied to each piece of scientific evidence used to sup port a regulation.
The Data Quality Act Those who oppose public health regula
tions or seek methods to delay health protec tions have a new tool in their arsenal: the Data Quality Act (DQA). The law originated as a rider on the appropriations bill for the Treasury Department, slipped into the legisla tion by Rep. Jo Ann Emerson (R-MO). It con sisted of two short paragraphs in the 712-
page Consolidated Appropriations Act of 2001,28 sandwiched between provisions to transfer ownership of land in Grand Rapids, Mich, and to settle litigation on nonforeign area cost-of-living allowances.98 There were no hearings or debate on the DQA, meaning no legislative history exists to help clarify Congress's intentions in passing it.
The DQA authorized the Office of Man agement and Budget (OMB) to develop guidelines to "ensure and maximize data quality" and to establish procedures allowing formal challenges to information dissemi nated by federal agencies. If someone be lieves that information disseminated by an agency is not of sufficient "quality, objectiv ity, utility, or integrity," they may request a correction to it. The DQA sounds harmless; it is difficult to argue against ensuring the quality and integrity of government-dissemi nated information. Yet, its devious concep tion suggests its intentions are not com pletely innocent.
It has been widely reported that Rep. Emerson inserted these provisions at the re quest of Jim Tozzi, an OMB economist during the 1970s and 1980s, 99-101 and founder of Multinational Business Services. Mr. Tozzi has been an advocate for industry-funded "regula tory reform" efforts and the founder of the Center for Regulatory Effectiveness. Mr. Tozzi proudly boasts about the convergence of the junk science movement and the DQA. "The law," he suggested, "will simply stop the `junk science' that can lead to useless and expen sive regulations."102
A petition filed in 2003 asked the EPA to discontinue disseminating its 1986 publica tion Guidance for Preventing Asbestos Disease Among Auto Mechanics, asserting the booklet "is routinely used to convey the mispercep tions that EPA has conducted a complete analysis of the scientific and medical literature and has concluded that brake mechanic work is in fact hazardous and that as a direct result brake mechanics are at increased risk of con tracting an asbestos-related disease, including mesothelioma, from such exposure."103
In response, EPA withdrew the publication from its Web site and announced plans to re place it with a revised publication.104 More than a year after receiving the petition, EPA has not issued a new booklet.
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for SKAPP is provided by the Common Benefit Trust, a fund established pursuant to a court order in the Sili cone Gel Breast Implant Products Liability Litigation.
The authors appreciate the helpful comments pro vided by members of the SKAPP planning committee, Carl Cranor, and two other peer reviewers.
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