Science vs. Politics in Regulatory Washington
Havender, William R.
SCIENCE VS. POLITICS IN REGULATORY WASHINGTON A sampling of some recent flim-flam. Athough the idea of government regulation no longer remains sacrosanct (to say the least), a related myth...
...Such questions included the validity of high-dose animal cancer tests as indicators of human risk, what to make of benign tumors, how to interpret conflicting results in different species, how to extrapolate risk from rats and mice to humans, whethe/ "promoters" (i.e., chemicals that cannot induce cancer on their own but can increase the carcinogenic effect of other substances) should be considered as dangerous as complete carcinogens, and whether or not safe doses (i.e., thresholds) exist...
...A committee of the American Statistical Association, in a letter to then FDA Commissioner Jere Goyan, described the FDA's interpretation of p-values as "foreign to everything that is taught in the statistics profession," and asked for a published retraction..None has yet appeared...
...How, then, could OSHA arrive at such "settlements...
...I checked with the writer: he got the figure from the TSSC report...
...Makes your drab 8 room hotel suite a home away from home...
...The report identified no authors beyond ten researchers from the National Cancer Institute, the National Institute of Environmental Health Sciences, and the National Institute for Occupational Safety and Health who were listed alphabetically as "contributors...
...Conceding in effect that there was no secure cancer case against cyclamate, it denied Abbott's petition not under the Delaney clause (which since 1958 has required the banning of any food additive shown in animal tests to cause cancer) but under a new reading of the "general safety" provision governing the approval of food additives, contending that FDA statistical "findings" had raised doubts about cyclamate's safety that Abbott had failed to rebut...
...None of the many other human studies in the past had shown such an effect (indeed, a comparable investigation in Baltimore had just failed to show it...
...In the June 1981 issue of the Journal of the National Cancer Institute, two of the world's leading cancer epidemiologists, Sir Richard Doll and Richard Peto, carefully reviewed the methodology of these reports...
...Shea chose Fe-1.3%C steel, which undergoes martensitic transformation during quenching and is known to form evidence, Abbott Laboratories petitioned to have cyclamate approved anew...
...Jane Fonda writes in her recent exercise book that "20 percent of cancer incidence today is at least partially caused by exposure in the work place...
...Item: In 1978 the results of a rat-feeding study at MIT, which alleged that sodium nitrite, a common food additive, induced lympho-mas (a kind of cancer) in rats, were reported to the FDA...
...Fragrant Harvest Company, 9001 Northgate, Suite 257, Austin, TX 78758 called the "Califano cancer report" for this reason) alleging that as much as 38 percent of all cancer in the United States could be traced to on-the-job chemical exposure, a tenfold increase over prevailing estimates...
...Item: In 1973, on the basis of new The Acoustic Detection Scientists have studied microstructural discontinuities in high-carbon steel since the early 1920s...
...The report was submitted to no professional journal, nor otherwise subjected to any outside scrutiny...
...The commission described the study as "literally impossible to interpret...
...Although the changes were not significant enough to reverse his conclusions, they raised doubts, leading FDA scientists to hire an independent group of pathologists to review the microscope slides of the animal tissues from Newberne's test...
...In all, Governor Carey's commission was forced to conclude that these studies had not established any harmful effect on physical health from the chemical seepage...
...Doll and Peto were blunt in their criticism of the government reports: they characterized one methodological flaw as "indefensible" and "a confidence trick...
...How do the super rich reflect their personalities and individualities in their mansions after they have filled them with custom made furniture and museum quality paintings...
...He proceeded to determine if AE is produced during aging...
...it took a single positive test in any species to outweigh any amount of negative evidence from other species or from actual experience in people (and when conflicting results concerned the same species, the positive findings would be given "preferential weight...
...Beverly Paigen, a researcher at the Roswell Park Memorial Institute in Buffalo, allegedly established an increase in nervous disorders, miscarriages, and birth defects among residents...
...It was merely filed in a post-hearing record at the Occupational Safety and Health Administration (OSHA), two weeks before Secretary Califano publicized its startling figures...
...Paul New-berne, called the FDA to make changes in the tumor incidences he had earlier reported...
...Not only that, the national concern stirred up by this incident led Congress to create the $1.6 billion "superfund" which the EPA now administers to control toxic wastes...
...By monitoring acoustic emissions, a materials research engineer at the General Motors Research Laboratories has arrived at a more detailed understanding of how one type of discontinuity occurs...
...Virtually a different flavor for every day of the month...
...Athough the idea of government regulation no longer remains sacrosanct (to say the least), a related myth continues to plague us: that government agencies make exemplary use of scientific findings in arriving at policy decisions...
...The grounds for bans of both saccharin and sodium nitrite are in fact more substantial than those that exist for cyclamate.* Item: A study of miscarriage rates in the vicinity of Alsea, Oregon, a forested area where the herbicide 2,4,5-T was sprayed each spring to control weeds, prompted the EPA to issue an emergency order in March 1979 banning virtually all uses of this chemical...
...They found a mare's nest of mistakes, and reaffirmed both the original estimate of one to five percent as the percentage of U.S...
...Item: In September 1979, HEW Secretary Joseph Califano, in a speech before the AFL-CIO, endorsed a government report (often .. .European royalty and oil sheiks do not use aerosol spray cans, wicks, etc...
...In other words, the original finding on which the ban was based could not be repeated despite strenuous efforts to do just that...
...Dante Picciano, claimed to have found such defects...
...in assessing a chemical's carcinogenicity, it gave the same weight to benign tumors as to lethal ones...
...Meanwhile, inventory losses from the sudden ban were estimated to be over $100 million...
...Long lasting...
...The FDA thus finally abandoned its effort to ban nitrite, two years after it began...
...Great for traveling...
...Item: In the spring of 1978, at the height of the saccharin controversy, a study by two Canadian epidemiologists received wide attention for claiming that the normal use of artificial sweeteners increased the risk of bladder cancer in men by 60 percent...
...The elastic energy released when microcracks form should produce a stress wave and associated high-frequency acoustic emission (AE...
...Once settled for the general case, such determinations could not be challenged when applied to a particular rule no matter what the evidence in the specific instance...
...in fact, there was no evidence whatever of any significant increase in tumor incidence...
...day after the EPA received the report...
...While these proceedings were still in progress, the conductor of the MIT study, Dr...
...As for the Picciano study, the commission found that it too lacked a control group∔one matched for current and past medical therapies, workplace exposures, and other factors knowa to be associated with genetic damage...
...Item: Two studies of the Love Canal health hazards were instrumental in raising public apprehension and inciting regulatory action...
...Ne Needless to say, the picture of how government agencies have used data in framing policies is far different from the envisioned ideal...
...All of these issues happened to be in active (not to say vehement) dispute among scientists then, and indeed they still are...
...In doing so, the FDA made stunning mistakes in its use of statistics and in its interpretation of animal cancer tests...
...Again, this did not prevent Commissioner Kennedy from immediately seeking to phase out nitrite from the nation's food supply...
...in other words, it assumed the worst case on every disputed point...
...An engineer at the General Motors Research Laboratories has devised an experiment that detects the microcracks as they occur...
...This order was issued one ∢See my article, "The Science and Politics of Cyclamate," in the Spring 1983 issue of the Public Interest...
...In fact, over the past few years an alarming number of initiatives, particularly in health and safety regulation, have been based on supposedly solid scientific "facts" that later turned out to he unfounded...
...William R. Havender is an independent consultant on environmental carcinogens who lives in Berkeley, California...
...The failure of these studies to prove injury does not, of course, necessarily mean that there was no injury...
...And that figure will zoom up to 40 percent in the years ahead...
...But during this time, consumers were subjected to needless worry every time they ate bacon, hot dogs, or cold euts, and the food industry suffered from economic uncertainty under the Damoclean threat of a total ban...
...Indeed, this claim to a superior method of decision-making was the essential justification for vesting these agencies with regulatory power in the first place...
...They reported that the original interpretation of lympho-mas was ten times too high...
...MARTENSITE is a hard mi...
...in particular, in the 1980 Report to the President by the Toxic Substance Strategy Committee (TSSC), a report coordinated by the Council on Environmental Quality...
...The real question, however, is how such insubstantial studies could set in motion the decision to evacuate hundreds of families from their homes (at a public cost approaching $100 million), causing them incalculable mental distress and uncertainty...
...This air freshener, home deodorizer and background fragrance also adds quiet elegance to corporate offices on the upper floors of Fortune 500 headquarters buildings...
...Indeed, were the FDA's novel interpretations in the cyclamate case to be applied consistently, neither of these other additives could be approved...
...Meanwhile, the Society of Toxicologists strongly criticized the FDA's use of animal cancer tests in this decision...
...Refresh your private 707 jet...
...As the common assumption has it, if not for Delaney, the case for saccharin would be overwhelming: the tumors observed in rats were nonlethal and caused only by unrealistically high doses...
...the preponderance of epi-demiological evidence is consistent with saccharin's safe use by humans...
...The FDA did not render its decision until 1980∔when it rejected the petition...
...and saccharin is widely believed to confer substantial health benefits on diabetics and dieters...
...Lewis Thomas, chief of the Memorial Sloan-Kettering Cancer Center, and including Dr...
...High-carbon martensite∔a highly stressed microstructure with a plate-like morphology∔contains microscopic ruptures or separations 10 to 20 microns in length...
...The Califano cancer report was meant to justify a great expansion of OSHA's powers, and OSHA's generic carcinogen policy would have eased their implementation...
...There have been enough cases to suggest that these are not mere accidents...
...a third as "absurd" and "a simple error to be corrected rather than a new scientific hypothesis to be considered,t Item: On January 22, 1980, the Federal Register published OSHA's new "generic" policy on carcinogens, a policy intended to reduce the burden of proof necessary to support nev regulations by settling certain recurring questions in advance...
...Enjoyment unconditionally guaranteed...
...damage) among the remaining Love Canal residents could be attributed to the chemical seepage...
...The ban, however, remains in force...
...Yet for all that∔and even before the study was published or subjected to peer review∔Food and Drug Commissioner Donald Kennedy said the Canadian study made it "virtually certain" that saccharin caused cancer in humans as well as rats...
...Check, M.O., Mastercard & Visa accepted...
...Nitrite-treated foods, which include virtually the entire pork industry, amount to some $12 billion in annual sales...
...The more widely accepted of two current hypotheses-the "impingement model"∔asserts that microcracking is transformation-induced, taking place due to the collision of martensite plates during the quench...
...Item: In 1969, a report claimed that cyclamate causes bladder cancer in rats...
...they indicate instead a pattern of deliberate agency inclination...
...These mistakes included calculating spurious p-values (the probability that the result occurred by chance) from unrandomized dosed and un-dosed animals, invalid grouping of tumors for statistical analysis, using wrong p-values in analyzing the results of multiple comparisons, and accepting results with p-values as high as .2 (and, in one case, .8) as biologically and legally significant...
...Using a piezoelectric transducer as the monitoring device, Dr...
...A portion of any flavor is enough to scent a standard 40 x 80 living room or small 40 foot yacht...
...The second study was commissioned in 1980 by the Environmental Protection Agency to determine whether possible chromosome defects (i.e., genetic...
...not even one such case had been securely documented...
...croconstituent of steel which forms when austenite, iron containing carbon in solid solution, is quenched from a high temperature...
...In theory, they were supposed to gather the "best" scientific and technical knowledge to make "enlightened" decisions in the public interest, free from the narrow vision and cloying self-interest of private business...
...Clearly, something is wrong when poor or distorted science, rather than being filtered out early in the policy-forming process, comes to dominate it instead...
...There are two main difficulties with this strategy, wholly apart from the question whether one is really "playing fair" by prohibiting discussion on precisely those points most in dispute...
...Saccharin, after all, has been shown in three separate rat tests to cause bladder tumors, and sodium nitrite, whether cancer causing or not, does react chemically in the body to produce carcinogenic nitrosamines...
...The ban has, of course, been postponed several times by Congress, the latest extending until this summer...
...Indeed the latter clause is usually considered the arch-villain forcing the FDA into unreasonable actions...
...Four days after this news hit the front pages, President Carter ordered the evacuation of 710 families...
...Normally, only p-values of less than .05 are regarded as statistically positive...
...it considered rats and mice to be valid proxies for humans...
...This was the first time that nitrite itself (as distinct from certain compounds that nitrite can form such as nitrosamines) was said to induce cancer, a surprising result to many in the animal-testing profession...
...Our old-money rich customers appreciate this feature because they are egregiously thrifty...
...Since then, there have been ten additional cyclamate studies in rats, seven in mice, one in hamsters, one in beagles, and two in monkeys...
...and safe doses of carcinogens were presumed not to exist...
...These figures have since shown up in almost every federal report concerning environmental cancer...
...They have been using our product of unsurpassed quality and accuracy of scent...
...Not content with reinterpreting statistics, the FDA reinterpreted the law as well...
...Arthur Upton, former head of the National Cancer Institute) criticized the Paigen study for its lack of an adequate comparison (control) group and failure to validate medically the illnesses claimed...
...The TSSC report would have supported a large increase in the budget, staff, and powers of the CEQ and other agencies concerned with the environment...
...This result was statistically weak (a shift of only six cases among the several hundred studied would make the result vanish), and the results in women seemed, oddly, to be just the reverse (i.e., artificial sweeteners seemed to protect them against bladder cancer...
...Yet after a decade or so of experience what we see is instance after instance of poor initiatives, ranging from bans and efforts to ban, using weak and later-refuted science, to massive regulatory programs set in motion by later-discredited studies, to decisions rooted in brazen tendentiousness and bias...
...It did so simply by making a policy decision to resolve all points of uncertainty on the side of "prutThese figures show up in the popular media, too...
...4.00, includes postage and handling...
...Through heat treatment, the steel can be tailored to applications requiring different degrees of ductility...
...that can be purchased in every supermarket...
...And the FDA's reasoning in its cyclamate decision greatly expanded the scope of the general safety provision governing food additives, so much so that the Delaney clause is now superfluous...
...These structural discontinuities, termed "microcracks," influence the mechanical properties of steel...
...The complete Yvon Chatel Collection, including all 27 scents, beautifully and elegantly packaged...
...Lack of a control group also meant that the control blood samples could not be processed simultaneously with those from exposed residents and scored "blind" (i.e., with the scorer's not knowing which were the control and which the exposed blood samples...
...The martensitic transformation produces steel that is hard and strong, but non-ductile...
...It is somewhat more surprising that the Wall Street Journal in a front-page article on January 3, 1983 wrote: "A recent government report suggests that work place hazards may account for 20% or more of cancers that will be detected in the next few decades...
...Texas residents add tax...
...Yet it is more economical to use than spray cans...
...Nor, absent Delaney, would there have been such a flap over nitrite even if Newberne's initial claims had been sustained, since the health benefit yielded by this chemical in preventing botulism is indisputable, and there is no suitable substitute...
...Though these were all high-dose, chronic feeding tests similar to the original, none showed a statistically significant increase in bladder cancer...
...The other model maintains that microcracking occurs during the aging of martensite after the plates have already formed...
...Also sent to peasants if they will respond on high quality stationery...
...Certified members of NSMA...
...We may do so anyway...
...One week after this report was made to the FDA, cyclamate was banned for broad consumer use, and shortly thereafter it was banned for all uses (e.g., for flavoring prescription drugs...
...This finding, part of the scientific base on which the FDA relied in its effort to ban saccharin, served to refute those who had argued that high-dose rat tests were inappropriate for inferring human risk...
...Michael Shea set out to determine what could be learned about the microcracking process by measuring AE...
...The denouement of this tale came in the fall of 1980 when a committee of scientists appointed by New York Governor Carey (and headed by Dr...
...How true were these alarming claims...
...Now this was news, because the general safety provision (which requires only a showing of "reasonable certainty" that no harm will result from an additive's intended use) has been interpreted traditionally as setting a much less stringent cancer standard than the Delaney clause...
...In May of that year, the author of the EPA study, Dr...
...Shea's ongoing research into high-carbon martensite led him to believe that the aging hypothesis was important...
...Until now, our product has appeared only in the most overpriced gift shops and boutiques in America and Europe...
...all found the study invalid...
...The second is that OSHA will find itself swamped with candidates for regulation as the cumulative effect of these "settlements" inflates both the number of substances deemed hazardous and the perceived degree of that hazard...
...another as the "one comparison of incidence rates that seems completely unreliable," yielding "quite fantastic and irregular variations in incidences...
...The first, carried out in 1978 by Dr...
...OSHA resolved these matters more or less arbitrarily: it dismissed the notion of an overdose in animal tests...
...Lasts all the way from Aspen to the Cote d'Azur...
...The "aging model" suggests that thermal activation enables carbon atoms to rearrange themselves, producing localized stresses high enough to cause microcracking...
...dence...
...The first is that by excluding available data on a given chemical, OSHA is ignoring the sort of specific detail needed for tailoring regulations wisely...
...it regarded substances that merely "promote" to be as hazardous as true carcinogens...
...Great for eliminating day old champagne odors...
...The study has since received 18 independent reviews by qualified scientists (including some in other countries...
...Although aspects of the microcracking phenomenon have been understood by metallurgists for more than fifty years, there is still no definitive explanation for when or how it occurs...
...cancer due to occupational exposures and an earlier understanding that cancer fates, when properly adjusted for smoking, have been steady or declining...
...Obviously, had the 1980 election not gone to Ronald Reagan, we would now be reaping a bountiful harvest from these germinal seedings...
...27 different refreshing flavors carefully handcrafted in the USA...
...The "scientific" base for a vast increase in regulatory activity and control was laid during the Carter years...
...For his study, Dr...
...In the meantime, three additional epidemiology studies (one of them performed by the National Cancer Institute and involving more than six times as many subjects as the Canadian study∔the largest study on bladder cancer ever conducted) have found no increase in cancer risk from the normal use of artificial sweeteners in either men or women...
Vol. 16 • June 1983 • No. 6
