Document pmroq10QxoQDvxvY9KNqmLEgB

FILE NAME: Doubt Science (DBTS) DATE: 2005 Sept DOC#: DBTS003 DOCUMENT DESCRIPTION: Journal Article from AJPH - Manufacturing Uncertainty: Contested Science and the Protection of the Public's Health and Environment PUBLIC HEALTH MATTERS Manufacturing Uncertainty: Contested Science and the Protection of the Public's Health and Environment | David Michaels, PhD, MPH, and Celeste Monforton, MPH Opponents of public health and environmental regulations often try to "man ufacture uncertainty" by questioning the validity of scientific evidence on which the regulations are based. Though most Identified with the tobacco industry, this strategy has also been used by producers of other hazardous products. Its pro ponents use the label "junk science" to ridicule research that threatens power ful interests. This strategy of manufacturing uncertainty is antithetical to the public health principle that decisions be made using the best evidence available. The public health system must ensure that scientific evidence is evaluated in a manner that assures the public's health and environment will be adequately protected. (Am J Public Health. 2005;95:S39-S48. doi:10.2105/AJPH.2004.043059) Eveiy bottle of aspirin sold in the United States today indudes a warning label advising parents that aspirin consumption by children with viral illnesses increases the child's risk of developing Reye's syndrome. Before the mandatory warnings were imposed by the Food and Drug Administration, the toll of Reye's syndrome was substantial: 5 5 5 cases reported in 1980. One in three children who developed Reye's syndrome died from it.1As pirin consumption increases risk o f Reye's syndrome by an estimated 4 0 0 0 percent.2 Today, less than a handful of Reye's syndrome cases are reported each year; the warning label and public education campaign have saved the lives of hundreds o f children.1,3,4 Although the disappearance o f Reye's syndrome is considered a "public health tri umph,"6 it is a bittersweet one. An untold number of children became disabled or died from Reye's syndrome while the aspirin in dustry delayed government efforts to warn parents, arguing that the scientific evidence was incomplete, unclear, or uncertain. In 1980, following the publication o f four studies showing that children with chicken pox or flu who took aspirin were more likely to develop Reye's syndrome, the Centers for Disease Control (CDC) issued an alert to the medical community. But the aspirin industry, with the assistance of the W hite House's Of fice o f Management and Budget, was able to delay a major government public educational program for two years, and mandatoiy labels for four years.6 Although the four studies were enough for the CDC to issue warnings, the industry raised 17 specific "flaws" in the studies7and insisted that more reliable studies were needed to establish a causal association betw een aspirin and Reye's syndrome. The aspirin industry continued to assert this de spite a Federal Advisory Committee's conclu sion that children with viral infections should avoid aspirin, going so far as to fund a public service announcement claiming, "We do know that no medication has been proven to cause Reye's" (emphasis in the original).8 Litigation by Public Citizen's Health Research Group (HRG) eventually forced the recalci trant Reagan administration to make the warnings mandatory in 1986. The aspirin manufacturers did not invent the strategy of questioning the underlying science in order to prevent regulation; it had been successfully employed for decades by polluters and producers of hazardous prod ucts. The strategy has now becom e so com mon that it is unusual for the science behind a public health or environmental regulation proposed in the United States not to b e chal lenged by a corporation facing regulation. The US National Toxicology Program (NTP), for example, publishes a list of substances that can cause cancer.9 Before a new sub stance is added to the list, there is a public process involving several independent sden- tific reviews. In an effort to avoid the "can cer-causing" label, industry-employed scien tists opposed the designation of cancer-caus ing for alcoholic beverages,10beiyllium ,11,12 crystalline silica,13,14 ethylene oxide,15-17 nickel compounds,18and certain wood dusts,18 challenging the evidence underlying the proposed designation. In each of these cases, the substance had already been cate gorized by the International Agency for Re search on Cancer as carcinogenic to humans.20 Further, in each o f these cases, the panel of nongovernment scientists re viewing the NTP nominations weighed the available evidence and voted to uphold the designation of cancer-causing. W hen new regulations are being consid ered, opponents raise the issue o f scientific uncertainty no matter how powerful or con clusive the evidence. Within the scientific community, for example, there is widespread consensus that broad-spectrum ultraviolet (UV) radiation from sunlight and tanning lamps causes skin cancer. Yet the Indoor Tan ning Association21 and others22,23 have at tempted to derail the NTP designation of cancer-causing by questioning the scientific evidence with which UV radiation was la beled a carcinogen. Environmental activists can be also guilty of using the existence of scientific uncertainty to advance policy aims through an overzeal ous application o f what has been labeled "the precautionary principle." If the w eighing of potential risks and benefits is transformed into a demand for certainty that a policy or action will result in no harm, scientific ad vances or public health interventions with the potential to genuinely improve the human condition can be disparaged and delayed.24,25 In parallel to their attempts to delay or prevent regulation through assertions of sci entific uncertainty, manufacturers of pollution and hazardous products have promoted the "junk science" movement, which attempts to Supplement 1, 2005, Voi 95, No. S I | American Journal of Public Health Michaels and Monforton j Peer Reviewed | Public Health Matters j S39 PUBLIC HEALTH MAHERS influence public opinion by ridiculing scien tists whose research threatens powerful inter ests, irrespective o f the quality o f those scien tists' research. Advocates for this perspective allege that many o f 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 epidem iologic 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 o f 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 system s to ad dress issues of public health and victim com pensation. The US Supreme Court's 1993 Daubert v Merrell Dow Pharmaceuticals, /nc26dedsion has enabled manufacturers of products alleged to have caused harm to ex dude credible sdence and sdentists from court cases.27 Similarly, the Data Quality Act28 provides a mechanism for parties to magnify differences between sdentists in order to avoid regulation and victim compensation. Our objective is to examine the historical developm ent and current applications of the "manufacturing uncertainty" and `junk sd 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 info 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 o f 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 sdentists to dispute first, that smokers were at greater risk o f dying o f 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 sdentific community eventually reached the consensus that tobacco smoke caused these condi tions.29-31 Despite the overwhelming sdentific 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 m id-1950s by H ill and Knowlton (H&K), the tobacco industry hired sdentists and commis sioned research to challenge the growing sd entific consensus linking dgarette smoking and severe health effects. Initially, H&K was engaged to minimize the public impact o f an American Cancer Sodety 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 sdentific uncertainty. In one confiden tial memorandum, H&K consultants boasted that after bVz years of effort, they success fully created "an awareness of the doubts and uncertainties about the dgarette charges." H&K credited tobacco-funded research that "forced a recognition that the dgarette the ory o f lung cancer causation is not estab lished sdentifically" and "raised many cogent questions concerning the validity of the dga 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 sdentists. The crite ria for publishing abides in the journal were straightforward: "The m ost 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 dearly 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 ourproduct since it is the best means of competing with the `body of fact' that exists in the minds o f the general public. It is also the means of establishing a controversy (emphasis added)."38 The boldness and success o f this campaign, together with the almost unimaginable human toll assodated with dgarette smoking, have resulted in the tobacco industry being labeled in the public consdousness as a uniquely nefarious, if not criminal, enterprise. Oust as there had been dispute over the sd entific evidence, the tobacco industry now promotes an alternative interpretation of the history o f 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 agreem ent 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 sdentific evi dence is ubiquitous in the organized opposi tion to the government's attempts to regulate health hazards. S40 | Public Health Matters | Peer Reviewed | Michaels and Monforton American Journal of Public Health | Supplement 1, 2005, Vol 95, No. S I PUBLIC HEALTH MAHERS DENYING THE EVIDENCE IN THE PRE-REGULATORY ERA Starting in the earliest years of the 20th century, there were a series o f 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 o f 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 m islead derisionmakers and the public in order to protect their ability to sell leaded paint and leaded gasoline. These public health historians note that early in die 1900s, lead was w ell 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 chem ical industry becam e alarmed in the early 1950s when a well-publidzed 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 w ell 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. Bany Castleman,49 Paul Brodeur,50 and others51,52 have docum ented 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 o f 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 (ALA); the co-director of H&K's Division o f 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 o f 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 environm ent"53 THE REGULATORY STATE AND THE GROWTH OF MANUFACTURED UNCERTAINTY The early 1970s ushered in the modem regulatory state in the United States. Agencies known by acronyms (e.g., EEA, OSHA, MSHA, CPSC, NHTSA) were created with the goals of protecting the environment and the public's health and safety.54 H ie sophistication of the regulated industries has grown along with the development o f the regulatory apparatus. Opponents o f proposed regulation relied (and continue to rely) on a menu o f 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 o f 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, tire 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 o f 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 Supplement 1, 2005, Vol 95, No. S I | American Journal of Public Health Michaels and Monforton | Peer Reviewed | Public Health Matters | S41 PUBLIC HEALTH MATTERS important dyes. D ecades earlier scientists had identified several of these aromatic amines, including benzidine and beta-nsphthylamine, 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 tc humans."57 There was little disagreem ent fr jm manufac turers as to the carcinogenicily o f benzidine; that debate had concluded decades earlier. Indeed, SOCMA and other opponents of OSHA's plan to regulate benzid ne acknowl edged that the chemical caused bladder can cer in humans. To justify their cpposition to OSHA's rule, SOCMA asserted that although workers had been exposed to dangerous lev els o f benzidine, current workp ace condi tions w ere much im proved and did not pose a risk to workers. In their testimony to OSHA they reported: "All of the reported in stances o f bladder tumors in be nzidine work ers of which w e 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 dichlcrobenzidine (DCB), a chemical structurally similar to ben zidine. The manufacturers of D CB strongly opposed regulating DCB as a cercinogen, as serting in June 1973 that it "is not a known human carcinogen and that the *e 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] o f cancer or other seri >us illness can be attributed to its use."60 By tl en, however, there were already several stud es 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 Occupationa Safety and Health (NIOSH) conducted a fi :ld survey of Allied Chemical's Buffalo, NY, facility where both benzidine and DCB were manufactured. NIOSH found that w hile rigoro rs controls were in place to control benzid: ne 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 m id-1960s. Like Allied Chemical, Upjohn opposed the proposed OSHA standard, as serting that the cases o f 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 o f 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."66 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 o f human exposure to MOCA at the DuPont Company."66 OSHA's proposed MOCA standard was never promulgated, and the two US produc ers o f MOCA ceased manufacturing the chemical by 1980. NIOSH researchers later conducted a screening program at one o f the facilities reporting that three employees, among 3 8 5 screened, were found to have tumors of the bladder Two of the men were nonsmokers under age 3 0 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 o f polyvinyl chloride (PVC), one o f the indus try's most important products. This type of cancer is exceedingly rare in humans, and the report o f 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 o f 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 o f 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 o f 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 OSpLA 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 S42 | Public Health Matters | Peer Reviewed | Michaels and Monforton American Journal of Public Health | Supplement 1, 2005, Vol 95, No. S I PUBLIC HEALTH MAHERS relations firm instructed SPI to e nphasize sci entific uncertainty and assert: "It has not been demonstrated that a health hazai d exists at the levels recommended by SPI."7311 its internal documents, however, H&K reminded SPI that "it should also be remembered tl tat the corol lary to this statement is that it ha s not been sci entifically demonstrated that the SPI recom mended levels are truly safe."75 THE ROOTS OF "JUNK SCIENCE" IN THE TOBACCO WARS Currently, the "junk science" m ovem ent is the m ost prominent public face of the attack on the scientific basis for compensating indi viduals injured by environment tl exposures, and for protecting the health of the public from many o f the sam e environm ental expo sures. Advocates for this perspective allege that many of the scientific studiss (and even scientific methods) used in the regulatory and legal arenas are fundamentally flawed, contradictory or incom plete, milking it wrong or premature to regulate the exposure in question or to compensate the worker or community resident allegedly made sick by the exposure. The label "junk science" was nvented and widely publicized to denigrate s aence sup porting environmental regulation and victim compensation. The junk science movement, w hich attempts to ridicule resea rch that threatens powerful interests (irrespective of the quality of that research), was spawned by these same industries that have been manu facturing uncertainty for decades. Defenders of pollution and dangerous products often call for policies t nd legal deci sions to be based in "sound science." This is a concept that is also rarely d ef ned, but pre sumably signifies the opposite c f whatever has been labeled as junk scien c;. University of California researchers Elisa Ong and Stan ton Glantz traced the origins o f the sound science movement by exam inin; thousands of pages of tobacco industry do ruments made public after litigation. They docu mented the central but disguise i role of Philip Morris in engineering and funding the sound science effort in operatin %an organiza tion called The Advancement for Sound Sci ence Coalition (TASSC).78 What Is Junk Science? It is difficult to find a meaningful defini tion of the term "junk science." Peter Huber, who is often credited with coining the term, offers a broad-ranging "I know it when I see it" description rather than definition: "Junk science is the mirror image o f real science, with much of the same form but none of the substance.. . . It is a hodgepodge of biased data, spurious inference, and logical legerdem ain.. . . It is a catalog of every con ceivable kind of error: data dredging, wishful thinking, truculent dogmatism, and, now and again, outright fraud."77 The junhscience.com website (which was founded and is run by the former executive director of TASSC), defines junk science as "faulty scientific data and analysis used to further a special agenda."78 The site contains a roster of "junk scientists," including six elected members o f the Institute o f Medicine o f the National Academy of Sciences, as well as four recipients o f the American College of Epidemiology's highest honor, the Abraham Lillienfeld Award.79 It appears that when sci entists have been asked to identify their most outstanding colleagues, they do not share the opinions o f the promoters of the junk science label. The accusation of junk science is not al ways used in actual regulatory proceedings, perhaps because its use would expose the an tiscientific bent of opponents of public health regulation. It is more effectively used in pub lic forums, where attacks on the scientific basis o f public health standards are weapons in the political opposition to the standards. W hen genuine scientific uncertainty does not exist, corporations fearing regulation follow the strategy developed by the tobacco indus try. They hire scientists who, while not deny ing that a relationship exists between the ex posure and the disease, argue that "the evidence is inconclusive." As a result, a lucra tive business of science for hire has emerged. Consultants in epidemiology, biostatistics, and toxicology are frequently engaged by indus tries facing regulation to dispute data used by regulatory agencies in developing public health and safety standards. These consult ants often reanalyze studies that had reported positive findings, with the elevated risks of disease disappearing in the reanalysis. Further proof o f the mercenary, rather than scientific, basis for the magnification and manufacture of scientific uncertainty comes from Frank Luntz, a political consultant to the Republican Party. In early 2 0 0 3 , Luntz ad vised his clients that "Winning the Global Warming Debate" could be accomplished by focusing on uncertainty and differences among scientists: Voters believe that there is no consensus about global warming within the scientific community. Should the public come to be lieve that the scientific issues are settled, their views about global warming will change accordingly. Therefore, you need to continue to make the lack o fscientific certainty a primary issue in the debate.. . . The scientific debate is closing [against us] but not yet closed. There is still a window o f opportunity to challenge the science [emphasis in original].80 In reality, there is a great deal of consensus among climate scientists about climate change.81-83 Luntz understands that it is pos sible to oppose (and delay) regulation without being branded as antienvironmental, by fo cusing on scientific uncertainty and by manu facturing uncertainty if it does not exist INSTITUTIONALIZING UNCERTAINTY As the above discussion makes dear, the junk sdence movement has little relation to actual sdence. The movement's adherents have never established a method to distin guish junk sdence from the real thing. As a result the label means little more than "I don't like your study."84 Beyond this, how ever, the junk sdence label was invented by, and has been a powerful tool in the hands of opponents of public health and environmen tal regulation and litigation. Although its meaning disappears when examined carefully, the term has gained widespread acceptance in the current debate over the use of sdentific evidence in public policy.85 Although part of its success can be attributed to the extensive finandal support junk sdence proponents re ceive from corporations eager to avoid regula tion and litigation, some of the success of the junk sdence movement lies in the very nature of scientific evidence dealing with human be ings. It is likely that in any given sdentific de bate involving human health, there will be Supplement 1, 2005, Vol 95, No. S I | American Journal of Public Health Michaels and Monforton | Peer Reviewed | Public Health Matters | S43 PUBLIC HEALTH MATTERS various published studies with inconsistent or even contradictory findings. The success o f the junk science movement can be seen in its two primary institutional manifestations: the Daubert26 decision and the Data Quality Act.28 Both o f hese are structured to force the piece-by- fiece exami nation o f scientific evidence, in contrast to the weight-of-the-evidence approad used by m ost scientists in reaching cond rsions in the face of uncertainty. The Daubert Decision In June 1993, the US Supren e Court is sued a ruling in Daubert v M em ll Dow Phar maceuticals, Inc, requiring feden 1judges to serve as sdentific gatekeepers, tllowing into evidence only expert testim ony that they deem relevant and reliable.28 A recent analy sis found that judges are requir ng physidans who testify as experts to apply standards of causal inference that exceed those which physicians use to diagnose and treat thenown patients.86 The effects o f the Daubert decision on liti gation that alleges harm from h izardous products can be seen in several cases involv ing Parlodel, a drug used through the early 1990s to stop postpartum lacta ion. Until it was withdrawn from the m arke, a number of young women who had been piescribed Parlodel had severe circulatory system epi sodes (inducting heart attacks a id strokes) shortly after taking the drug. Oil 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 Foe d and Drug Administration (FDA) in 1985 requested that the drug's manufacturer indude 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 d u g to lactating w om en.87 Yet w hen several women su :d the drug's manufacturers, claiming Parloc el was re sponsible for their illness, theii cases were essentially thrown out of court for lack of scientific certainty. Judges in several jurisdic tions refused to allow jurors to consider the testim ony of sdentists or physi dans who agreed w ith the FDA that, on he basis of case reports, animal studies, and the way the drug works in the body, Parlodel could cause drculatory disorders. Applying the Daubert rule, the judges demanded a level of certainty that was virtually im possible to provide.86 For m ore than 10 years, Daubert has been the law of the land. Scholars and other au thors have written on its im pad and used ac tual judidal derisions to illustrate the discon nect between legal proof and sdentific evidence.88-92 Few authors, however, have explored the organized movement to extend Dauberts reach from the judidaiy into the executive branch, in particular, into the fed eral rulemaking arena. Emboldened by the success of Daubert in limiting the use o f sdentific evidence in the courts, antiregulatoiy interests are promoting file application o f Daubert principles in judi d al review o f federal regulation.93-96 Most notably, Daubert is prominently featured in the offidal position on sdentific information in federal rulemaking o f the US Chamber of Commerce: The same standards of relevance and reliability that safeguard the rights oflitigants 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 o f public health protections, espedally those advanced in the face of srientifie uncertainty, should be wary of calls to extend Daubert to the regulatory arena The legal, economic, and political obstades faced by regulators w ill increase dramatically when Daubert-like criteria are applied to each piece o f sdentific 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 Qualify 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 o f two short paragraphs in the 712- page Consolidated Appropriations A d of 2001,28 sandwiched between provisions to transfer ownership of [and 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 o f Man agement and Budget (OMB) to develop guidelines to "ensure and maximize data qualify" and to establish procedures allowing formal challenges to information dissemi nated by federal agencies. If som eone 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 qualify and integrity o f 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 1 9 8 0 s,99-101 and founder of Multinational Business Services, Mr. Tozzi has been an advocate for industry-funded "regula tory reform" efforts and the founder o f 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 sim ply stop the junk science' that can lead to useless and expen sive regulations."102 A petition filed in 2 0 0 3 asked the EPA to discontinue disseminating its 1986 publica tion Guidancefor 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 m edical 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.104More than a year after receiving the petition, EPA has not issued a new booklet S44 | Public Health Matters | Peer Reviewed | Michaels and Monforton American Journal of Public Health j Supplement 1, 2005, Vol 95, No. S I PUBLIC HEALTH MATTERS RESTORING INTEGRITY 1 0 PUBLIC HEALTH SCIENCE Every first-year public health student is taught how John Snow stopped a cholera epi demic in London During a 10-day period in September 1854, during which more than 5 0 0 Londoners died firom the cisease, Snow used a city map to mark the loc ation of each household with a case of cholera He quickly determined that Londoners whi >drank from one particular water source were at the high est risk for the disease, and he recommended removing the handle o f the pump supplying water from that source.103 By using the best evidence available at the time, additional deaths were avoided. If government officials in London had demanded abso ute certainty, no preventive measures w ould'lave been taken for another 3 0 years, until the cholera bacterium (Vibrio cholerae) was identified. Protecting the public's healtt requires reg ulatory policies and approach that explic itly acknowledge uncertainty, v h ile providing parameters that support dedsic nmaking based on limited data in situations where sig nificant risk to human health o:the environ m ent exists. These parameters should be based in the fundamental paradigm govern ing public health: decisions mu >tbe made using the best evidence currenl ly available. Even if these parameters for de cisionmaking are rigorously applied, the debate over the sdence underpinning public health regula tion is unlikely to disappear b e u se protec tive actions often involve substantial finandal costs. This debate is further complicated by the reliance of government agencies on regu lated parties for much o f the scientific infor mation used to formulate regulations, a de pendence made necessary by lim ited federal research funding. In order to limit the impact c f manufac tured uncertainty and to restore scientific in tegrity to the regulatory process, the public health system must reestablish rrocedures to enable practitioners to evaluate and apply sdentific evidence in a manner th it assures the public's health and environment w ill be ade quately protected. Although thf re are no magic bullets to cure this probli :m, increased transparency concerning conflicts of interest, espedally involving the finand; 1relationship between the authors and sponsors o f studies used in regulatory and legal proceedings, is clearly warranted. Following a series of alarming instances in which the sponsors o f research used their fi nandal control to the detriment of the public's health, a group of leading biom edical journals have established policies that make their pub lished artides transparent to commerdal bias and that require authors to accept full control and responsibility for their work. These jour nals will now only publish studies done under contracts in which the investigators had the right to publish the findings without the con sent or control of the sponsor. In a joint state ment, the editors of the journals asserted that contractual arrangements allowing sponsor control o f publication "erode the fabric o f in tellectual inquiry that has fostered so much high-quality clinical research."106 Federal regulatory agendes, charged with protecting the public's health and environ m ent have no requirements for "research in tegrity" comparable to those of medical jour nals. W hen studies are submitted to the EPA or OSHA, for example, for consideration in rulemaking, the agendes do not have the au thority to inquire who paid for the studies, and whether these studies would have seen the light o f day if the sponsor didn't approve the results. As a result, sponsors with dear conflicts o f interest have no incentive to relin quish control over sponsored research gov erning their products and activities. Federal agendes should adopt, at a mini mum, requirements for research integrity comparable to those used by biom edical jour nals: Parties that submit data from research they have sponsored must disdose if the in vestigators had the contractual right to pub lish their findings without the consent or in fluence o f the sponsor.107 Some policymakers fail to recognize that all studies are not created equal. Opponents of regulation often hire sdentific consulting firms that spedalize in "product defense" to reanalyze data from the studies used to sup port or shape public health and environmen tal protections. This sometimes results in the existence o f what appear to be equal and op posite studies, encouraging policymakers to do nothing in the face of what appear to be contradictory findings. Epidemiologists recognize that the results from post hoc analyses do not have the same validity as the findings of studies designed to test a prior hypothesis. Regulators, jurists, and other policymakers are often called on to ascribe a relative weight to different stud ies; while no evidence should be totally dis carded, the findings of post hoc analyses (and reanalyses) should be labeled accordingly and not be treated as equal to those o f original research, and should be accorded less weight and significance. In our current regulatory system, debate over science has become a substitute for de bate over policy. Opponents of regulation use the existence o f uncertainty, no matter its magnitude or importance, as a tool to counter imposition of public health protections that may cause them financial difficulty. It is im portant that those charged with protecting the public's health recognize that the desire for absolute scientific certainty is both counter productive and futile. This recognition under lies the w ise words of Sir Austin Bradford Hill, delivered in an address to the Royal So ciety o f Medicine in 1965: All scientific work is incomplete--whether it be observational or experimental. All scientific work is liable to be upset or modified by ad vancing knowledge. That does not confer upon us a freedom to ignore the knowledge we al ready have, or to postpone action that it ap pears to demand at a given tim e.. . . Who knows, asked Robert Browning, but the world may end tonight? True, but on available evi dence most of us make ready to commute on the 8:30 next day.108 About the Authors David Michaels and CelesteMonfortonis are with the De partment o fEnvironmental and Occupational Health, George Washington University School o fPublic Health and Health Services, Washington, DC. Requestsfo r reprints should be sent to David Michaels, PhD, Department o fEnvironmental and Occupational Health, George Washington University School o fPublic Health and Health Services, 2100 M S t NW , Suite 203, Washington, DC 2 0 0 3 7 (e-mail: eohdmm@gmmc.edu) This article was accepted September 9, 200 4 . Contributors David Michaels and Celeste Monforton both researched and wrote this article. Acknowledgments This work was supported by the Project on Sdentific Knowledge and Public Policy (SKAPP). Major support Supplement 1, 2005, Vol 95, No. S:. | American Journal of Public Health Michaels and Monforton | Peer Reviewed | Public Health Matters j S45 PUBLIC HEALTH MATTERS for SKAPP is provided by the Coirnno i Benefit Trust, a fund established pursuant to a court o *der in the Sili cone Gel Breast Implant Products Lial ility Litigation. The authors appreciate the helpful comments pix>vided by members of the SKAPP plan ling committee, Carl Cranor, and two other peer revie' vers. References 1. Belay E, BreseeJ, Holman R, H im A, Shahriari A, Schonberger L. Reye's syndrome in the United States from 1981 through 1997. N Englf M id. 1999; 340: 1377-1382. 2. Hurwitz E, Barrett M, Bregman I ), et al. Public health service study of Reye's syndror le and medica tions: Report of the main study. JAM A. 1987;257: 1905-1911. 3. Goldman L. Epidemiology in the regulatory arena. Am JEpidemiol. 2001;154:S18-S26. 4. Davis D, Buflier P. Reduction of ileaths after drug labeling for risk of Reye's syndrome. I ancet. 1992; 340:1042. 5. Monto A. The disappearance of 1[eye's syndrome: a public health triumph. N EnglJ Med. 1999;340: 1423-1424. 6. Hilts P. ProtectingAmerica's Healt t New York, NY: Allred A. Knopf; 2003. 7. 4 7 Federal Register 57886 (1982). Labeling for salicylate-containing products, advance d notice of pro posed rulemaking, Food and Drug Administration, De cember 28,1982. 8. Lurie P, Wolfe S. Aspirin and Rey e's syndrome. In: Lurie P, Caiy D, Tanio C, Wolfe S, Paradigmsfor Change: A Public Health Textbookfo r M edical, Dental, Pharmacy and Nursing Students. Washi igton, DC: Pub lic Citizen's Health Research Group (ui published). 9. Tenth Report on Carcinogens. US I lepartment of Health and Human Services, National Toxicology Pro gram. Available at: http://ehp.nieh5.nil .gov/roc/toclO. html. Accessed December 4, 2003. 10. Waddell W. Public comment as r sported in the Report of Carcinogens Subcommittee t leeting, National Toxicology Program Board of Scientific Counselors. De cember 2--3 ,1 9 9 8 . http://ntp.niehs.ni l.gov/indexcfin? objeetid=O6F3F9F7-0DEB-D47E-C4A6 53A074666360. Accessed March 14, 2005. 11. Roth HD. Public comment as rep sited in the Re port of Carcinogens Subcommittee Met ting, National Toxicology Program Board of Scientific Counselors, Jan uary 2 0 --21, 2000. http://ntp.niehs.nili.gov/index.cfin? objecdd=06F5398C-F235-2FF4-F5DAi!01B3FB43BD7. Accessed March 15, 2005. 12. Trichopoulos D. Public comment t s reported in the Report of Carcinogens Subcommittee M reting, National Toxicology Program Board of Scientific (Counselors, Janu ary 20-2 1 , 2000. http://ritp.niehs.nih.j ov/index.dm? objectid=O6F5398C-F235-2FF4-F5DAF01B3FB43BD7. Accessed March 15, 2005. 13. Glenn R. Public comment as repc rted in the Re port of Carcinogens Subcommittee Meeting, National Toxicology Program Board of Scientific Counselors, De cember 2--3 ,1 9 9 8 . http://ntp.niehs.nili.gov/indexcfin? objectid=06F3F9F7-0DEB-D47E-C4A6i S3A074666360, Accessed March 14, 2005. 14. Moll W. Public comment as report ed in the Report of Carcinogens Subcommittee Meeting, National Toxicol ogy Program Board of Scientific Counselors, December 2 -3 , 1998. http://ntp.mehs.nih.gov/mdex.cfm7objectid" 06F3F9F70DEB-D47E-C4A683A074666360, Ac cessed March 14, 2005. 15. Preston J. Public comment as reported in the Report of Carcinogens Subcommittee Meeting, National Toxicol ogy Program Board of Scientific Counselors, December 2 -3 , 1998. http://ntp.mehs.nih.gov/mdex.cfm7objecticN 06F3F9F7-ODEB-D47E-C4A683A074666360, Ac cessed March 14, 2005. 16. Teta MJ. Public comment as reported in the Report of Carcinogens Subcommittee Meeting, National Toxicol ogy Program Board of Scientific Counselors, December 2 -3 ,1 9 9 8 . http://ntp.mehs.nih.gov/index.cfin7objectid" 06F3F9F7-ODEB-D47E-C4A683A074666360, Ac cessed March 14, 2005. 17. Schotland S. Public comment as reported in the Re port of Carcinogens Subcommittee Meeting, National Toxi cology Program Board of Scientific Counselors, December 2-3,1998. http://ntpmehs.nih.gov/mdeccfm7objectid" 06F3F9F7-ODEB-D47E-C4A683A074666360. Ac cessed March 14, 2005. 18. Oiler A. Public comment as reported in the Report of Carcinogens Subcommittee Meeting, National Toxicol ogy Program Board of Scientific Counselors, December 2-3 , 1998. http://ntp.nielis.nih.gov/index.cfm7objectid" 06F3F9F7-0DEB-D47E-C4A683A074666360, Ac cessed March 14, 2005. 19. Blot W. Public comment as reported in the Re port of Carcinogens Subcommittee Meeting, National Toxicology Program Board of Scientific Counselors, De cember 13--15, 2000. Available at: http://ntp-server. niehs.nih.gov/htdocs/Liason/121300.pdf. Accessed De cember 3, 2003. 20. International Agency for Research on Cancer. Overall evaluations of carcinogenicity to humans. Avail able at: http://monogiaphs.iarc.fr/monoeval/crthgr01. html. Accessed May 29, 2003. 21. Ross S. Public comment as reported in the Report of Carcinogens Subcommittee Meeting, National Toxi cology Program Board of Scientific Counselors, Decem ber 13--15, 2000. Available at: http://nqr-server.mehs. nih.gov/htdocs/Liason/1213 00.pdf. Accessed Decem ber 3, 2003. 22. Smith D. Public comment as reported in the Re port of Carcinogens Subcommittee Meeting, National Toxicology Program Board of Scientific Counselors, December 13--15, 2000. Available at: http://nip-server. niehs.nih.gov/htdocs/Liason/121300.pdf. Accessed December 3, 2003. 23. Deveney J. Public comment as reported in the Report of Carcinogens Subcommittee Meeting, National Toxicology Program Board of Scientific Counselors, December 13-15, 2000. Available a t http://ntp-server. niehs.nih.gov/htdocs/Liason/121300.pdf. Accessed De cember 3, 2003. 24. Ozonoff D. On being careful what we wish for: some difficulties with operationalizing the Precaution ary Principle. Intf Occup Med Environ Health. 2004; 17(1):35--41. 25. Ozonoff D. Anthrax: the precautionary principle goes postal. Public Health Rep. 2002;117(6):513-520. 26. Daubert v Merreil Dow Pharmaceuticals, Inc 113 S.Ct 2786 (1993). 27. Daubert: the most influential Supreme Court rul ing you've never heard of. Available at: http://www. defendingscience.org. Accessed August 1, 2004. 28. 515 of the Consolidated Appropriations Act of 2001, P.L. 106-554. 29. Smoking and Health: A Report o f the Advisory Com mittee to the Surgeon General o f the Public Health Service Washington, DC: US Department of Health, Education, and Welfare; 1964. DHEW publication 1103. 30. Smoking and Health: A Report o f the Surgeon Gen eral Washington, DC: US Department of Health, Edu cation, and Welfare; 1979. DHEW publication 79 50066. 31. Women and Smoking 2001: A Report o f the Sur geon General Washington, DC: US Department of Health and Human Services; 2001. 32. Kessler D. A Question o fIntent: A Great American Battle with a Deadly Industry. New York, NY: Public Af fairs; 2001. 33. Glantz S, Slade J, Bero L, Hanauer P, Barnes D. The Cigarette Papers. Berkeley: University of California Press; 1996. 34. Kluger R. Ashes to Ashes: America's Hundred-Year Cigarette War, the Public Health, and the Unabashed Tri umph ofPhUip Morris. New York, NY: Random House; 1996. 35. Confidential Public Relations Report to the T1RC, November 3, 1955. Lorillard Document 82106862 82106866. Available at: http://tobaccodocuments.org/ lor. Accessed December 4, 2004. 36. Hill and Knowlton. Public Relations Proposal for the Tobacco Industry (draft for discussion). July 9,1959. RJ Reynolds Document 502051941-502051954. Avail able at: http://tobaccodocirments.org/rjr. Accessed De cember 4, 2004. 37. Thompson C Memorandum to William Kloepfer, Jr, and the Tobacco Institute. Inc, ftom Hill and Knowlton, Inc; October 18,1968. Tobacco Institute Document TIMN007148B-1491. Available at: http:// tobaccodocuments.org/ti. Accessed December 15, 2004. 38. Smoking and Health Proposal. Brown & Williamson Document No. 332506. Available at: http://tobaccodocuments.org/bw. Accessed December 11, 2004. 39. Proctor RN. Should medical historians be working for the tobacco industry? lancet 2004;363:1174-1175. 40. Markowitz G, Rosner D. Industry challenges to the principle of prevention in public health: the precau tionary principle in historical perspective. Public Health Rep. 2002;117(6):501-512. 41. Proctor RN. Cancer Wats: How Politics Shapes What We Know and Don't Know About Cancer. New York, NY: Basic Books, 1995. 42. Markowitz G, Rosner D. Deceit and Denial: The Deadly Politics o fIndustrial Pollution. Berkeley: Univer sity of California Press; 2002. 43. Markowitz G, Rosner D. "Cater to the children": the role of the lead industry in a public health tragedy, 1900-1955. Am f Public Health. 2000;90(l):36-46. 44. Warren C. Brush with Death: A Social History o f Lead Poisoning. Baltimore, Vid: Johns Hopkins Univer sity Press; 2000. S46 | Public Health Matters | Peer f viewed | Michaels and Monforton American Journal of Public Health | Supplement 1, 2005, Vol 95, No. S I PUBLIC HEALTH MATTERS 45. Wilson, BS. Legislative histoiy oi the Pesticides Residues Amendment of 1954 and the Delaney Clause of the Food Additives Amendment of 1958. In: Regu lating Pesticides in Food: The Delaney 1'aradox. Washing ton, DC: National Academies Press; 1987. 46. Jackson M. Subject: Manufacture: g Chemists' As sociation; Hill and Knowlton, Inc, mer 10 to John W HDl. August 1, 1951. 47. Minutes of the Meeting of Direi to rs o f the Manufacturing Chemists' Associatior, Inc 1951-1952. Chemical Industry Arc] lives of the Environmental Working Group. Available at: http://www.chemicalindustiyarchive5. ng. Accessed December 4, 2003. 48. Miller K. The Voice o fBusiness: H II and Knowlton and Postwar Public Relations. Chapel H 11: University of North Carolina Press; 1999. 49. Castleman B. Asbestos: Medical at d Legal Aspects. New York, NY: Harcourt Brace Jovano ddi; 1984. 50. Brodeur P. Outrageous Misconduct The Asbestos Industry on Trial New York, NY: Panth ion Books; 1985. 51. Ozonoff D. Failed warnings: asber tos-related dis ease and industrial medicine. In: Bayer R, ed., Case Studies in the Politics o fProfessional Res ronsibility. New York, NY: Oxford University Press, 1988. 52. Egilman D, Fehnel C, Bohme SR. Exposing the "myth" of ABC, "anything but chrysotile": a critique of the Canadian asbestos mining indushy and McGill Uni versity chrysotfle studies. Am fin d Mea 2003;44: 540-57. 53. Marder H. (senior vice president, Hill and Knowl ton) Letter to James E. Gulick, vice pre: ident, Brush Wellman, Inc; Attachment entitled: Div sion of Scien tific, Technical and Environmental Affai rs; February 21 1989. ' 54. Cranor CF. Regulating Toxic Substa tees: A Philoso phy o fScience and the Law. New York, h Y: Oxford Uni versity Press, 1993. 55. Michaels D. Waiting for the body count: corporate decision making and bladder cancer in he U.S. dye in dustry. M edAnthro Q. 1988;2:215-231. 56. Michaels D. W hen science isn't en >ugh: Wilhelm Hueper, Robert A.M. Case and the limii s of scientific evidence in preventing occupational bla Ider cancer. Int fO ccup Environ Health. 1 9 9 5 ;l:2 7 8 -2 i 8. 57. 39 Federal Register 3756. (1974). Part 1910, Occupational Safety and Health Standards, Carcino gens. Vol 39, No. 20, January 29, 1974 page 3756. 58. Comments on the production and t ise of benzi dine, SOCMA Benzidine Task Fbrce, March 9, 1973. 59. Morgan DL, of Cleary, Gottlieb, Steen & Hamil ton, on behalf of domestic manufacturer; or users of 3,3'-Dichlorobenzidine. Comments to OIIHA's Stan dards Advisory Committee on Cardnogr ns [Letter]; June 26, 1973. 60. DCB Subcommittee of the Dry Col >r Manufactur ers' Association. Comments to OSHA on the Use of Dichlorobenzidine, March 9, 1973 [Docket H003, Ex hibit 2-8], 61. Hueper WC. Occupational and Envi -onmental Can cers o f the Urinary System. New Haven, Conn: Yale Uni versity Press; 1969. 62. Pames W, Shuler PJ, Donaldson H i 1. Field Survey o fAllied Chemical Corporation. Cincinnati, Ohio: Na tional Institute for Occupational Safety and Health, Di vision of Field Studies and Clinical Investigations; Octo ber 16, 1972. 63. Murray W M Affidavit concerning 3 ,3 'Dichloroben zidine. May 15, 1973. Submitted to OSHA's Standards Advisory Committee on Carcinogens by Donald L. Morgan of Geary, Gottlieb, Steen & Hamilton; June 26, 1973. 64. Ouellet-Hellstrom R, Rench JD. Bladder cancer in cidence in acrylamine workers. / Occup Environ Med. 1996;38:1239-1247. 65. National Association of Manufacturers. Comments on OSHA's emergency temporary standard for certain carcinogens [Docket H-003J September 12, 1973. 66. Korbitz BC, on behalf of the Polyurethane Manu facturers Association. Comments on OSHAs proposed standard on 4,4' methylene bis (2-chloroaniline) Docket H-050A Mardi 10, 1975. 67. Ward E, Halperin W, Thun M, et al. Bladder tu mors in two young males occupationally exposed to MBOCA. Am fin d Med 1988;14:267-272. 68. Angiosarcoma of the liver among polyvinyl chlo ride workers. M orbidity and M ortality Weekly Report, February 9,1974. Atlanta, GA: US Department of Health, Education and Welfare; 1974. , 69. Forman D, Bennett B, Stafford J, Doll R. Exposure to vinyl chloride and angiosarcomas of the liver: a re port of the register of cases. B rf Ind Med. 1985;42: 750-753. 70. Sprrtas R, Kaminski R. Angiosarcoma of the liver in vinyl chloride/polyvinyl chloride workers:1977 up date of the NIOSH register. J Occup Med. 1978;20: 427-429. 71. Delorme F, Theriault G. Ten cases of angiosar coma of the liver in Shawinigan, Quebec J Occup Med. 1978;20:338-340. 72. Brady J, Liberatore F, Harper P, et aL Angiosar coma of the liver: an epidemiologic survey. / Natl Can cer Inst 1977;59:1383-1385. 73. Wagoner JK, Infante PF. Vinyl chloride: a case for the use of laboratory bioassay in the regulatory control procedure. In: Hiatt HH, Watson JD, Winsten JA, eds. Origins o fHuman Cancer: Book C. Human Risk Assess ment. Cold Spring Harbor, NY: Cold Spring Harbor Laboratory; 1977. 74. 39 Federal Register. 16896 (1974). Vinyl chloride proposed standard. Vol. 39, No. 92, May 10, 1974, page 16896. 75. Moore J. Letter from Hill and Knowlton, Inc to John Spano, Monsanto Company, with accompanying Recommendationsfo r PublicAffairs Programfo r SPI's Vinyl Chlonde Committee. Phase I: Preparationfo r OSHA Hearing. Document No. 19740612_001_ 00004426. June 12, 1974. Available at: http://www. chemicalindustiyarchives.org. Accessed December 1, 2003. 76. Ong EK, Glantz SA Constructing "sound science" and "good epidemiology": Tobacco, lawyers, and public relations firms. Am f Public Health. 2001;91:1749-1758. 77. Huber PW. Galileo's Revenge New York, NY: Basic Books; 1991. 78. JunkSdence.com: all the junk that's fit to debunk. Available at: http://www.junksdence.com/define.htm. Accessed August 13, 2004. 79. Junk sdence at-large, junk sdentists. Available at: http://www.junksdence.com/rosterhtml. Accessed Au gust 13, 2004. 80. Luntz memo on the environment Available at Envi ronmental Working Group at: http://www.ewg.org:16080/ briefings/luntzmemo. Accessed August 13,2004. 81. National Academy of Sdences. Climate Change Sdence: An Analysis o fSome Key Questions. Washing ton, DC: National Academies Press; 2001. Available at: http://books.nap.edu/books/O309075742/himl. Accessed August 4, 2004. 82. National Academy of Sdences. Planning Climate and Global Change Research -A Review of the Draft U.S. Climate Change Sdence Program Strategic Plan. Wash ington, DC: National Academies Press; 2003. 83. Kennedy D. The policy drought on climate change. Sdence 2003;299:309. 84. Edmond G, Mercer D. Trashing "junk sdence." Stan Tech L Rev. 1998;3. 85. Herrick CN, Jamieson D. Junk science and envi ronmental policy: obscuring public debate with mis leading discourse. Philos Public Policy Q. 2001 -21 11-16. 86. Kassirer JP, Cedi JS. Inconsistency in evidentiary standards for medical testimony. JAM A. 2002;2881382-1386. 87. FDA moves to end use of bromocriptine for post partum breast engorgement FDA news release, August 17, 1994. Available at: http://www.fda.gov/bbs/topics/ ANSWERS/ANS00594htinl. Accessed August 11, 2004. ' 88. Berger MA. What has a decade of Daubert wrought? Am f Public Health. 2 0 0 5 ;9 5 5 5 9 -S 6 5 . 89. Cecil JS. Ten years ofjudidal gatekeeping under Daubert Am f PublicHealth 2005;95:S74-S80. 90. Haack S. Trial and error: the Supreme Court's philosophy of sdence. Am J Public Health. 2005;95: S66-S73. 91. Cranor CF, Eastmond DA Sdentific ignorance and reliable patterns of evidence in toxic tort causa tion: is there a need for liability reform? Law Contemp Probs. 2001;64:5-48. 92. Edmond G, Mercer D. Daubert and the exclusion ary ethos: the convergence of corporate and judidal at titudes towards the admissibility of expert evidence in tort litigation. Law & Policy. 2 0 0 4 ;26:231-257. 93. Goldsmith WJ. Occupational Safety and Health Act's rulemaking procedures. Testimony presented be fore US House of Representatives, Subcommittee on Workforce Protections, House Committee on Education and the Workforce; June 14, 2001. http://edworkforce. house.gov/hearings/107th/wp/osha61401/goldsmith htm. Accessed verified March 14, 2005. 94. Raul AC, Dwyer JZ. "Regulatory Daubert": A pro posal to enhance judicial review of agency sdence by incorporating Daubert prindples into administrative law. Law Contemp Probs. 2003;66:7-44. 95. McGarity TO. On the prospect of "Daubertizing" judidal review of risk assessment Law Contemp Probs. 2003;66:155-225. 96. Wagner WE. Importing Daubert to administrative agendes through the information quality act J Law Pol ity. 2004;12:589-617. 97. US Chamber of Commerce. Scientific Information Supplement 1, 2005, Vol 95, No. S I | American Journal o f Public Health Michaels and Monforton | Peer Reviewed | Public Health Matters | S47 PUBLIC HEALTH MATTERS in Federal Rulemaking. Policy statement, January 2002. Available at: http://www.uschamber.com/govemment/ issues/regulatoiy/scientific,,rulemakin;5.htm. Accessed August 13, 2004. 98. 514 and 516 of the Consolidated Appropria tions Act of 2001, P.L. 106-554 99. Twohey M. Jim Tozzi: on jazz and OMB. The Fed eral Paper. November 18, 2002:1. 100. Tozzi J. Memorandum to Matthew Winokur, direc tor of worldwide regulatory affairs, Philip Morris. Sub ject: Meeting with EPA officials on da n access/data quality. January 11, 1999. Philip Morris Document 20652 3 0 9 3 5 . Available at: http://tobaccodocuinciie;. org/pm. Accessed December 4, 2003. 101. Tozzi J. Letter to Robert Elves, Philip Morris. Febru ary 29, 2000. Philip Morris Document 2072826830. Available at: http://tobaccodocumentii.org/pm. Ac cessed December 4, 2003. 102. New Law Means More Federal Pules Can Be Chal lenged The Center for Regulatoiy Effectiveness, CRE in the News. Available at: http://www.thecre.com/ newshtml. Accessed December 8, 2003. 103. Morgan, Lewis & Brockius, LLP. le tte r to US Envi ronmental Protection Agency; August 19, 2003. Avail able at: http://www.epa.gov/oei/qualityguidelines/ aireqcorrectionsub/12467.pdf. Accessed December 8, 2003. 104. EPA notice about revising Guidancefo r Preventing Asbestos Disease Among Auto Mechanics (`Gold Book"). Available at: http://www.epa.gov/asbestos/autolrtml. Accessed August 13, 2004. 105. Snow J. On the mode of communication of chol era [published in 1855 in London]. I r : Frost WH, ed. Snow on Cholera. New York, NY: The Commonwealth Fund; 1936. 106. Davidoff F, DeAngelis CD, Drazen JF, et al. Spon sorship, authorship, and accountability. JAMA. 2001; 286:1232. 107. Michaels D, Wagner W. Disclosures in regulatory science. Science. 2003;302:2073. 108. Hill AB. The environment and disease: association or causation? Proc Royal SocM ed 196i5;58:295-300. S48 | Public Health Matters | Peer Reviewed | Michaels and Monforton American Journal of Public Health | Supplement 1, 2005, Vol 95, No. S I