Plaintiffs, Defendants.

Transcription

1 SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF NEW YORK MYRTLE VAUGHTERS and DONALD MORRIS, as CO-ADMINISTRATORS OF THE ESTATE OF SHIRLEY D. MARANO, DECEASED, Index No /93 - against - Plaintiffs, CONSOLIDATED EDISON COMPANY OF NEW YORK, INC. and JOHN DOE MANUFACTURING COMPANY, that name being fictitious, the true name of the Defendant being unknown to the Plaintiff, the company intended being the manufacturer and/or maintenance company employed by the Defendant CONSOLIDATED EDISON COMPANY OF NEW YORK, INC., Defendants. BRIEF OF AMICI CURIAE ELEANOR ADAIR, ROBERT K. ADAIR, NICOLAAS BLOEMBERGEN, ALLAN CORMACK, SHELDON LEE GLASHOW, DAVID HAFEMEISTER, LEONARD D. HAMILTON, RODNEY W. NICHOLS, ROBERT L. PARK, ROBERT V. POUND, FREDERICK SEITZ, and RICHARD WILSON IN SUPPORT OF DEFENDANT CONSOLIDATED EDISON COMPANY OF NEW YORK, INC. Introductory Statement Amici curiae Eleanor B. Adair, Robert K. Adair, Nicolaas Bloembergen, Allan Cormack, Sheldon Lee Glashow, David Hafemeister, Leonard D. Hamilton, Rodney Nichols, Robert L. Park, Robert V. Pound, Frederick Seitz, and Richard Wilson respectfully submit this amicus curiae brief in support of the motion for summary judgment of defendant Consolidated Edison Company of New York, Inc. 1

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3 Interest of Amici Amici are scientists who have studied the issue of the health effects of electromagnetic fields ["EMF"] and believe that the current concern that EMF causes disease, particularly cancer, is not supported by the weight of credible scientific evidence. Amici further believe that the very recent report of the National Research Council of the National Academy of Sciences, issued October 31, 1996, which finds that there is no evidence that extremely low frequency electromagnetic fields causes disease in humans correctly evaluates, assimilates and articulates the current state of scientific knowledge regarding the health effects of EMF. Amici are concerned that any decision which even implicitly can be seen as support for the concerns about EMF would lend credibility to beliefs which are essentially without scientific foundation and based on irrational or speculative fear of injury. Eleanor B. Adair is a Research Fellow of the John B. Pierce Laboratory, a senior resident scientist and lecturer at Yale University. She holds a Ph.D. in psychology with a minor in optical physics. Her current field of specialization is the study of the thermoregulatory effects on humans and non-human primates of exposure to electromagnetic fields. She is a fellow of the IEEE. She has been a co-chairman of Subcommittee 4 of SCC28 (formerly ANSI C95.4) which promulgated ANSI/IEEE C guidelines for human exposure to radio frequency fields, and a member of Subcommittee 3 of SCC28, which is charged with setting guidelines for exposure to electric and magnetic fields from 0 to 3 khz (which includes 60 Hz powerline fields). Robert K. Adair is Sterling Professor of Physics at Yale University and formerly the chairman of the Department of Physics at Yale University. He was previously Associate Director for High Energy and Nuclear Physics of the Brookhaven National Laboratory. He holds a Ph.D. in Physics. He is a member of the National Acaemy of Sciences. Nicolaas Bloembergen is a Nobel laureate in Physics. He is Professor Emeritus of Physics 3

4 at Harvard University. Prof. Bloembergen was awarded the National Medal of Science in Allan Cormack is a Nobel laureate in Medicine and University Professor Emeritus at Tufts University. Sheldon Lee Glashow is a Nobel laureate in Physics and Mellon Professor of Physics at Harvard University. David Hafemeister is Professor of Physics at California Polytechnic State University. Leonard D. Hamilton is Professor of Medicine at the State University of New York at Stony Brook and Adjunct Professor of Biometry and Epidemiolofy at the Medical University of South Carolina at Charleston. He was, until his retirement from that position, the Head of the Biomedical and Environmental Assessment Group at the Brookhaven National Laboratory, whose task is to assess the health and environmental effects of energy sources, including the effects of radiation. He received his doctorate in medicine from Oxford University and a Ph.D. in Experimental Pathology from Cambridge University. Rodney Nichols is President and chief executive officer of the New York Academy of Sciences. He has been a member of the Executive Committee of the Carnegie Commission on Science, Technology and Government and was the principal author of the Commission's report "Science and Technology in U.S. International Affairs" (1992). He is a member of the National Academy of Sciences Committee on International Organizations and Programs. He is the chair of the Committee on Science and Technology in Developing Countries of the International Council of Scientific Unions. Robert L. Park is Professor of Physics at the University of Maryland. 4

5 Robert V. Pound is Mallinckrodt Professor of Physics (emeritus) at Harvard University, former Chairman of the Department of Physics and former Director of the Physics Laboratories at Harvard University. Professor Pound was awarded the National Medal of Science in Frederick Seitz is President Emeritus of The Rockefeller University, a leading science and medicine research institution. In addition to an earned Ph.D. in physics, he has been awarded 30 honorary degrees from such institutions as Princeton University, Northwestern University, University of Michigan, Brown University, New York University and University of Pennsylvania. He has received numerous awards for his work as a scientist and educator, including the National Medal of Science (1973), the Franklin Medal (1965), the Department of Defense Distinguished Service Award (1968), the Nassau Distinguished Service Award (1969) and the American College of Physicians Edward R. Loveland Memorial Award (1983). He served two terms as president of the National Academy of Sciences and has been Chairman of the Board of the Sloan-Kettering Institute for Cancer Research. He has served on numerous government and academic boards, councils and committees, including the President's Science Advisory Committee, the National Cancer Advisory Board, the Naval Research Advisory Committee and the Advisory Council of the Smithsonian Institution. He has been a member of the boards of trustees of numerous universities and is a member of many United States and foreign scientific academies. He is an editor or a member of the editorial board of numerous scientific publications. Richard Wilson is Mallinckrodt Professor of Physics and former Chairman of the Department of Physics at Harvard University. 5

6 FACTS Amici understand that plaintiffs allege that the decedent, Shirley D. Marano, who worked one floor above two 500 kilovolt ampere ("kva") "step-down" transformers which reduced the incoming voltage from 13,406 volts to 216 volts, which were owned and operated by defendant Consolidated Edison Company of New York, Inc. (hereafter "Con Ed"), contracted ovarian and/or breast cancer, and that plaintiffs allege that the cancer was caused by Mrs. Marano's exposure to electromagnetic fields generated by the transformers. Amici also understand that measurements of the magnetic fields around the transformers were made by Aubrey Braz, an engineer employed by Con Ed, and that the magnetic fields in the office in which Mrs. Marano worked and the adjacent office ranged from approximately 10.1 milligauss (hereafter "mg") to 62.6 mg, with the readings in the immediate area of Mrs. Marano's desk being from 13.3 mg to 20.6 mg. 6

7 ARGUMENT I. The Nature of Extremely Low Frequency Electromagnetic Fields In the United States and Canada, the flow of current in electric powerlines reverses direction 60 times each second: the power is therefore said to have a frequency of 60 cycles per second, or 60 hertz (Hz). In turn, this oscillation causes the electric and magnetic fields arising from the powerlines to likewise reverse their direction 60 times each second; they are therefore said to be 60-hertz fields or power-frequency fields. Sixty-hertz fields are also called extremely low frequency fields, for the following reason. Such fields are only one form of the energy known as electromagnetic radiation. That energy, which is both natural and man made in origin, has a wide variety of effects on matter depending on its frequency: the higher the frequency, the shorter the wavelength and the greater the energy. The frequencies of different forms of electromagnetic energy extend over an enormous range, commonly represented as a spectrum. At one end of the electromagnetic spectrum are X-rays and gamma rays, which have extremely high frequencies (10 Hz to 10 Hz and above) and hence extremely high 1 energy. Next on the electromagnetic spectrum is ultraviolet light, which has somewhat lower frequencies (10 Hz to 10 Hz) and hence somewhat lower energy. Below it is the familiar spectrum of visible light, followed in sequence by infrared waves, microwaves (1 billion Hz to 300 billion Hz), and television and radio waves (500,000 Hz to 1 billion Hz). Although each of these has progressively lower frequencies and energy, even the lowest (AM radio) has a frequency range of 500,000 Hz (500 khz) to 1.6 million Hz (1600 khz). Lowest of all on the electromagnetic spectrum are electric and magnetic fields such as those arising from the powerlines in this case A frequency of 10 Hz is thus a number of cycles per second of 1 followed by 25 zeros. The figures given in this paragraph, of course, are approximations. 7

8 When their frequency of a mere 60 Hz is compared with the frequency of the other forms of electromagnetic energy, it is evident why they are called "extremely low frequency" fields. An important consequence of the low frequency and resulting low energy of electric and magnetic fields is that they are non-ionizing. An atom or molecule is said to be ionized when one or more of its electrons is dislodged by an energetic outside force such as very high frequency radiation. Gamma rays, X-rays, and high frequency ultraviolet light are termed ionizing radiation because their energy is so great that they are capable of ionizing atoms or molecules of ordinary matter. When that matter is human tissue, ionization can damage the DNA molecules of the cells, causing mutations and various forms of cancer. However, the energy carried in 60 Hz fields is much too small to break molecular or chemical bonds. Like visible light, infrared, microwaves, and television and radio waves, electric and magnetic fields are therefore termed non-ionizing radiation. 2 One form of non-ionizing radiation-microwaves-can nevertheless cause biological damage by a different process: microwaves are absorbed by the water present in tissue, and can induce 3 currents strong enough to heat the tissue. But while 60 Hz fields can also set up currents in tissue, these currents are much weaker. The amount of heat they generate is trivial compared to the natural 2 Although 60 Hz fields are included in the general category of non-ionizing radiation because they are undoubtedly non-ionizing, they are not properly called "radiation": as the United States Environmental Protection Agency has observed, electric and magnetic fields from 60 Hz exposures are not considered 'radiation' for various technical reasons... (EPA Q&A, supra, at p. 2.) One of those reasons is the distinction between propagating fields or waves, which can travel far from their source (e.g., visible light or radio waves), and confined fields, which diminish rapidly with distance from their source. Because the power-frequency fields of public health concern are not of the propagating type, it is technically inappropriate to refer to them as "radiation." Indeed, in common usage even propagating waves such as visible light and radio waves are not spoken of as "radiation"; that term is generally reserved for ionizing radiation, such as X-rays and gamma rays. 3 Hz. This is how a microwave oven heats food. The microwaves that it generates have a frequency of 2.45 billion 8

9 heat that comes from the cells of the body. There is no reason to believe that health effects can be caused by such minuscule amounts of heat. It would be helpful to understand the basic components of the electric power "grid" or system. Power plant generators deliver electric power to the system at approximately 20 kv. "Step-up" transformers increase that voltage to higher levels for transmission purposes, because the higher the voltage, the less power lost in the wires. The power is then carried long distances over transmission lines at voltages that range between 50 kv and 765 kv. Transmission lines terminate at substations, where "step-down" transformers reduce the voltage for distribution purposes. The power is then carried shorter distances over various types of distribution lines, at various voltages below 50 kv, to the ultimate users. By the time the power is delivered to the commercial or residential user, its voltage has been reduced to 120 or 240 volts. It is also important to stress that electric and magnetic fields arise not only from powerlines but also from the distribution and use of that power inside the home, office, or factory. One common source of such fields is the wall and ceiling wiring of the building itself, which delivers the electricity to the individual rooms in which it is used for lighting, heating, or operating appliances. Although the magnetic fields of modem wall and ceiling wiring are small, older wiring can make significant contributions to the average magnetic field in homes. Another source, often overlooked, is the "ground currents" that flow through the water pipes, gas lines, or steel framing typically used for grounding the wiring system of the building: the magnetic fields that they produce can contribute substantially to the overall magnetic field in homes or offices. A third common source of electric and magnetic fields is electric equipment and appliances. In the factory, this means all machines and tools powered by electricity-in other words, virtually all industrial machinery in use today. In the office, this means fluorescent light fixtures and all such 9

10 equipment as computers, video display terminals, printers, copiers, typewriters, and fax machines. In the home, this means television sets, videocassette recorders, compact disc players, radios, table lamps, vacuum cleaners, power tools, portable heaters, electric blankets, electric shavers, hair dryers, clothes washers and dryers, irons, electric ovens and ranges, refrigerators and freezers, as well as toasters, coffeemakers, food processors, and all other small kitchen appliances. The most intense magnetic fields in the home are found near appliances (particularly those with small motors or transformers such as hairdryers and fluorescent light fixtures). Although they are probably not the main source of the magnetic background because their fields decrease rapidly with distance and users generally spend only brief periods of time operating such appliances (with the exception of electric blankets and television sets), they are ubiquitous in the modern home. 4 In the typical home or office, fields of various strengths arise from the wall and ceiling wiring, the ground currents, and all electric machinery, equipment, and appliances. Keeping fields out of the home and office would mean keeping any electricity from coming into or being used in the home or office. 4 The following chart lists the magnetic fields (in mg) of some common appliances, measured at two distances from the source. In each case the figure is given as a range, because of such variations as the make and model of the appliance and the power level at which it is operated. Appliance At 1.2 Inches At 12 Inches Electric Blanket 2 to 80 not applicable Clothes Washer 8 to to 30 Television 25 to to 20 Electric Range 60 to 2,000 4 to 40 Microwave Oven 750 to 2, to 80 Fluorescent Lamp 400 to 4,000 5 to 20 Electric Shaver 150 to 15,000 not applicable Hair Dryer 60 to 20,000 1 to 70 10

11 II. The Epidemiological Evidence Does Not Demonstrate a Causal Association Between Electromagnetic Fields and Cancer The present public concern that low intensity electromagnetic fields that are near electric power lines are hazardous originated primarily from a report of an epidemiological study that the incidence of childhood leukemia near Denver was greater among families who lived close to power 5 lines than among those that lived further away. In addition, it appears that the only, or certainly the principal, evidence plaintiffs have introduced or sought to introduce to establish a link between electromagnetic fields and disease are epidemiological studies. In this brief, therefore, we address the epidemiological evidence that low intensity 6 electromagnetic fields from power lines can cause cancer. We conclude that the evidence does not justify the link between proximity to 60 hertz electric power sources and cancer, such as that claimed by plaintiffs. Even if plaintiffs' fears of such a link, and those of others, are genuinely believed by them, they are not grounded in adequate scientific evidence. Epidemiological data are often expressed in terms of a "Risk Ratio." The "Risk Ratio," found by the Denver study, that is the ratio of the number of leukemias seen in the population studied to the number one would expect if a similar population chosen at random were studied, is about 2.3, whereas it would be approximately 1 (unity) in the absence of an association. The authors of the Denver study postulated that leukemia incidence is "associated" with the presence of power lines, and by inference with magnetic fields of very low intensity -- 3 milligauss (one milligauss is one thousandth of a Gauss). This postulate was immediately linked to an earlier suggestion that electric 5 N. Wertheimer and E. Leeper, "Electric Wiring Configurations and Childhood Cancer," 109 Am. J. Epidemiology 273 (1979). 6 We discuss the studies of power lines because they are by far the most numerous involving extremely low frequency sources. The findings of those studies would also apply to persons living or working near 60 hertz electric transformers, such as those involved in this case. 11

12 and magnetic fields of low intensity can produce effects on cells -- particularly on the rate of calcium efflux from the brain tissue of chickens. 7 It is important to realize that if an epidemiological study were repeated under otherwise identical conditions at a different place and time, the result will not be identical. There will almost certainly be differences because of the limited number of people observed in each study. One can, however, imagine the repetition of the study a large number of times, and a distribution of Risk Ratios would be found. If the Risk Ratio were found to be greater than unity in 97.5% of the repeated studies, it is the usual practice in epidemiology to call it "statistically significant." The value of the Risk Ratio below which 2.5% of the repeated studies fall is called the "lower confidence limit," and the Risk Ratio above which 2.5% of the studies fall is called the "upper confidence limit." Since 95% of the studies fall within these limits, the upper limit is often called the "upper 95% confidence limit." But statistical variation due to population sampling is only one reason for the Risk Ratio being different from the "true" answer. There are other uncertainties which are hard to assess, and which, in epidemiological studies (unlike in experiments in the physical sciences), are 8 not estimated and quoted. The "residential" studies of proximity to power lines have led to other epidemiological 9 studies and laboratory attempts to induce cancer in animals and studies in vitro, such as those of 7 S.M. Bawin and W.R Adey, "Sensitivity of Calcium Binding in Cerebral Tissue to Weak Environmental Electric Fields Oscillating at Low Frequencies," 73 Proc. Natl. Acad. Sciences 999 (1976). 8 We note here that in statistical theory the word "error" is used to describe the difference of the measured quantity from the true one. We avoid using the word "error" here because we do not wish to imply mistake or culpability. 9 See B. Wilson, R. Steven, L. Anderson, eds., Extremely Low Frequency Electromagnetic Fields: The Question of Cancer (1990). 12

13 10 Bawin and Adey. The results of these laboratory studies are reported in over 1,000 references. However, they are far from conclusive, and they would not be considered significant indicators of 11 any problem without the epidemiological studies. A. The Epidemiological Studies The published epidemiological studies of electromagnetic fields are of three distinct types. The first type concerns the effects of power lines on nearby residents, the second type examines the effects of electric blankets on users, and the third type explores the effects of exposure to magnetic fields (among many other environmental polluting agents) on workers in various occupations. It is a fundamental statistical principle that one should not ask a statistical question when one 12 already knows the answer -- the so-called "Feynman Trap." Wertheimer and Leeper, the authors of the Denver study, did not ask whether leukemias were associated with the proximity to power lines until they had already noticed that some were. Their observation is thus inherently incapable of proving, statistically, that proximity to power lines causes cancer. Yet it is obvious that Wertheimer and Leeper generated two hypotheses by asking two questions: "Is proximity to power lines associated with increases in leukemia?" and "Is this association due to the magnetic fields at the houses in question?" Their study is what is called a "hypothesis generating study." We must 10 Note 2, supra. See also detailed discussions in the ORAU report, note 21,infra,and in B. Wilson, et al., note 4, supra. We note that Blackmun, et al., in a series of papers discuss the effect claimed by Bamin and Adey and find a complex set of "windows." If these could be replicated by others, it would be very convincing, but they have not been. 11 I. Nair, M.G. Morgan and H.K. Florig, "Biological Effects of Power Frequency Electric and Magnetic Fields: Background Paper," OTA-Bl-E53 (1989). 12 Posing a problem for his undergraduate class, Richard Feynman, the Nobel physicist, noted a car in the parking lot, with a particular license plate, ARW357. One can easily assess the probability of seeing this license plate, by multiplying the independent probabilities of seeing each number (1/10) and each letter (1/26). The answer is one in eighteen million. Yet Feynman had just seen the license plate, so it had unity probability! Since Feynman asked the question when he already knew the answer, the statistical calculation was invalid. This point has been raised, less dramatically, by many others. See D.L. Goodstein, "Richard P. Feynman, Teacher," Physics Today (February 1989). 13

14 turn to the work of other investigators to address the two questions generated by the Denver study Epidemiological studies by Savitz, et al. and London, et al. also found that there seems to be an association between childhood leukemia and proximity to power lines, albeit smaller than that suggested by Wertheimer and Leeper (the Risk Ratio is smaller in each of the subsequent studies). This might suggest that the hypothesis of Wertheimer and Leeper had been confirmed, but the experiments were not exact replications. The effects observed by Savitz, et al. were not apparent if the exposure classes were taken to be identical with Wertheimer and Leeper, but only showed up when a fourth (sub)class was added. Therefore, the statistical interpretation is not obvious, and the magnitude of the problem has not been assessed. Moreover, before reaching a conclusion, one must look at all the data. Thirteen studies of childhood leukemia due to residential exposure were reviewed and compared by Washburn, et al. 15 If one makes the assumption that the only uncertainty in each study was the statistical sampling error due to the limited number of leukemias observed and then weighted each study by the number of cases and averaged the results, one finds a statistically significant relationship between leukemia and some measure of proximity to power lines (Risk Ratio = 1.49 with 5% and 95% confidence limits 16 of 1.11 and 2.00). 13 D.A. Savitz, H. Wachtel, F.A. Barnes, E.M. John, and J.G. Tvrdik, "Case-Control Study of Childhood Cancer and Exposure to 60-Hz Magnetic Fields," 128 Am. J. Epidemiology 21 (1988). 14 S.J. London, D.C. Thomas, J.D. Bowman, E. Sobel, T.S. Chen, and J.M. Peters, "Exposure to Residential Electromagnetic Fields and the Risk of Childhood Leukemia" 134(9) Am. J. Epidemiology (1991) 15 E.P. Washburn, M.J. Orza, J.A. Berlin, W.J. Nicholson, A.C. Todd, H. Frumkin, and T.C. Chalmers, "Residential Proximity to Electricity Transmission and Distribution Equipment and Risk of Childhood Leukemia, Childhood Lymphoma, and Childhood Nervous System Tumors: Systematic Review, Evaluation, and Meta Analysis," 5 Cancer Causes and Control (1994). 16 We observe that Washburn, et al. included the hypothesis generating experiment of Wertheimer and Leeper in their average. For a proper statistical interpretation it should be excluded, and correction should also be made for the post hoc choice of grouping by Savitz, et al. and Feychting and Ahlbom, note 15, infra. Each result would be smaller and the statistical significance less. 14

15 But one should look at the data further. If the magnetic fields really increased the incidence of leukemia, we would expect that the Risk Ratio would be higher when the fields themselves were measured than when only a "surrogate" for the fields, the proximity to power lines, is used. The opposite is the case. In only three studies were magnetic field measurements made contemporaneously at the houses in question. In these the Risk Ratio for proximity to power lines was 1.57 (and statistically significantly different from unity) but for actual field measurements was 1.30 (and not statistically significantly different from unity). This seems to many scientists to exonerate magnetic fields as the real cause of the leukemias found. Various alternative explanations have been postulated for the claimed association. Jones, 17 et al. showed that there is a selection bias: people who live near power lines move residences more frequently and hence are not comparable to those who do not live near power lines. This will 18 produce a "selection bias." If the persons who moved their residence frequently respond to researchers' questions if they have leukemia, but do not usually respond if they do not have the disease, it would (erroneously) appear that the power lines cause leukemia. Proximity to power lines is not then a proper "surrogate" for whatever causes the disease. It has been noted that overhead power lines are usually found in older neighborhoods where straight roads lead to moderate 19 traffic. Newer secluded neighborhoods often have no overhead powerlines. It remains possible that the proximity to power lines is a better indicator of past electromagnetic fields than present (contemporaneous) measurements. A recent study from 17 T.L. Jones, C.H. Shih, D.H. Thurston, B.J. Ware and P. Cole, "Selection Bias from Differential Residential Mobility as an Explanation for Associations of Wire Codes with Childhood Cancer," 46 J. Clin. Epidem (1993). 18 We note here that a "selection bias" is different from a "confounder" or alternate cause; it is closer to an actual error in logic. 19 Wachtel & Pearcy, paper presented to the Bioelectromechanical Society, June

16 20 21 Sweden included in the review by Washburn, et al., was one of the studies that found no correlation between cancer and contemporaneously measured magnetic fields, but found a correlation with fields calculated from historically recorded electric currents in the wires. The historical calculation was made for the time when the leukemia was diagnosed. Although the Risk Ratio in this particular study is reasonably large (about 3), the number of leukemias observed was 22 small and therefore the study is of marginal statistical significance. Moreover, it appears that the authors chose to examine the historically calculated fields after seeing the data. Since they did not ask the specific question in advance, the "Feynman Trap" may apply and the statistical validity is 23 reduced by an unknown amount. There are other concerns with this study. There are two possible surrogates for the relevant past average of electromagnetic fields -- contemporaneous measured fields, and fields calculated from historical usage. Marshall has pointed out that if there is really a causal relationship one would expect a higher Risk Ratio if a combination of the two measures of 24 exposure to electric transmission lines were used. Yet the Risk Ratios average to be less when a combination of the two measures, historically calculated fields and contemporaneously measured fields, is used. In five of the studies searches were made for lymphomas (found not to be statistically significant) and in seven for nervous system tumors (statistically significant relationship found with 20 M. Feychting and A. Ahlbom, "Magnetic Fields and Cancer In Persons Living Close to High Voltage Power Lines in Sweden," 89(50) Lakartidningen (1992) also in 138 Am. J. Epidemiology (1993). See also, M. Feychting and A. Ahlbom, "Magnetic Fields, Leukemia, and Central Nervous System Tumors in Swedish Adults Residing Near High-Voltage Power Lines," 5(5) Epidemiology (1994) Washburn, et al., supra note 10. P = 0.05 or a probability of 5% that a risk ratio this large or greater could occur by chance. 23 A. Shlyakhter and R. Wilson, "Magnetic Fields and Cancer in Children Residing Near Swedish High-Voltage Power Lines" 141 Am. J. Epidemiology 378 (1995) 24 J. Marshall, "The Use of Dual or Multiple Reports in Epidemiology," 8 Statistics in Medicine (1989). 16

17 proximity to power lines). After the Wertheimer and Leeper study, there was a search for situations where there is a larger magnetic field than produced by power lines, and also situations where there is a reliable comparison population. One comparison is with electric blankets. The wires in almost all electric blankets were wound very simply, and produced a magnetic field 10 to 100 times that of neighboring power lines. This immediately suggests that one compare cancer incidence rates among those who regularly use electric blankets with the rates among those who do not. The first such study suggested a difference, 25 but more careful studies found none. This is a very important conclusion, because the comparison is direct and the likely confounding effects are fewer than for the power line studies described earlier. 26 The ORAU report carefully analyzed a number of occupational studies. These are grouped under studies with different cancer end points. They include brain cancer in children, lung cancer, and leukemia. It is important to note that leukemia is at least four different diseases. The different 27 types are:! Acute Lymphocytic Leukemia (ALL) - the dominant type among children.! Acute Myelogenous Leukemia (AML)! Chronic Lymphocytic Leukemia (CLL)! Chronic Myelogenous Leukemia (CML) 25 R. Verrault, N.S. Weiss, K.A. Hollenbach, C.H., Starder and J.R. Daling, "Use of Electric Blankets and Risk of Testicular Cancer" 131 Am. J. Epidemiology (1990); J.E. Vena, S. Graham, R. Hellman, M. Swanson and J. Brasure, "Use of Electric Blankets and Risk of Post Menopausal Breast Cancer" 134 Am. J. Epidemiology (1991) 26 Oak Ridge Associated Universities, "Health Effects of Low Frequency Electric and Magnetic Fields," ORAU 92/F8 (1990), commissioned by the Committee on Interagency Research and Policy (CIRRPC). 27 Hematologists are sure that each of the four can be distinguished in diagnosis, and each probably has a different etiology. 17

18 If the effect of exposure to EMF is real, one expects the same distribution of cancers in all studies, and the same distribution of types of leukemia. Indeed, there should be the same type of leukemia in the residential studies also. This does not seem to be the case. The studies of leukemias among people in occupations where there is exposure to electromagnetic fields involve situations which are more complex than the studies of exposure to electric blankets. Occupations expose people to many different pollutants, so that a small overall increase in cancer is not unlikely and would be hard to attribute to electromagnetic fields. Because these are case control studies there was no automatic search for all cancers. There are now 52 studies that looked for undifferentiated leukemia, several more than reviewed in the ORAU report. The additional studies do not change the picture. The average Risk Ratio (properly weighted for 28 statistical accuracy) is small It is significant if only statistical sampling errors are included. The non-statistical errors change this picture. The incidence of Acute Myelogenous Leukemia (AML) in 27 studies gives an average Risk Ratio of about 1.35, but in the studies where both total (undifferentiated) leukemia and AML were studied the risk of AML is greater than the risk of undifferentiated leukemia only half of the time. The slight average increase need not, however, be related to electromagnetic fields even if it can be properly attributed to occupation. AML can be caused, for example, by exposure to benzene, probably by exposure to other solvents and also by exposure to ionizing radiation. 29 A summary of the results of the occupational studies also shows a small increase for CLL. 28 Y.S Loh, A.I. Shlyakhter and R. Wilson, "Electromagnetic Field and the Risk of Leukemia and Brain Cancer: a Review of Epidemiological Literature," Second Michelson Research Conference, Kalispell, Montana (1995). 29 Id. 18

19 (The Risk Ratio for an average of 14 studies is 1.26). One of the recent studies, from Sweden 30 shows a small (statistically insignificant) trend of an increase of Risk Ratio with occupational 31 exposure to magnetic fields. But one must be cautious. While it might be true that the proximity to electromagnetic fields in the workplace increases cancer incidence, that does not constitute proof that electromagnetic fields are responsible for the increase. One must distinguish between risks that are occupationally related 32 and risks that are related to electromagnetic fields. In the discussion in the paragraphs above, epidemiological studies, weighted by their statistical accuracy, have been combined. This would be correct if there are no systematic errors, such as a selection bias or unknown "confounders" (alternate explanations). As noted earlier, epidemiologists, in contrast to physical scientists, quote only the statistical errors, and merely attempt to describe the other errors in the test, but do not quantify them. But it must not be assumed that they do not exist. In the much simpler field of measurement of physical constants, scientists endeavor to estimate these systematic errors and they routinely quote their estimates. Nonetheless, many authors have demonstrated that physical scientists routinely underestimate the errors and that 30 B. Floderus, T. Persson, C. Stenlund, A. Wennberg, A., Å. Ost and B. Knave, "Occupational Exposure to Electromagnetic Fields in Relation to Leukemia and Brain Tumors: A Case-Control Study in Sweden," 4 Cancer Causes and Control 465 (1993); see also G. Thériault, M. Goldberg, A.B. Miller, B. Armstrong, P. Guénel, J. Deadman, E. Imbernon, T. To, A. Chevalier, D. Cyr, C. Wall, "Cancer Risks Associated With Occupational Exposure to Magnetic Fields Among Electric Utility Workers in Ontario and Quebec, Canada, and France: ," 139 Am. J. Epidemiology 550 (1994). 31 The exposure was estimated from a complex study of the occupation and may well be unreliable. 32 It would be incorrect to attribute the risk specifically to electromagnetic fields. In some situations such an incorrect attribution may not immediately matter. For example, another study, S. J. London, et al., "Exposure to Magnetic Fields Among Electrical Workers in Relation to Leukemia Risk in Los Angeles County," 26 Am. J. Industrial Med. 27 (1964) found that engineers working for telephone companies had less exposure to EMF than workers in"non-electrical" businesses. A plaintiff might be awarded damages for occupational risks, regardless of the intermediate vector (if the court is satisfied that a statistical error, a selection bias or a confounder were not the cause). But if the reasons for the legal judgments are not precisely stated, this might create legal precedents that cannot be justified on the basis of science and are hard to reverse. 19

20 33 the confidence limits are much wider than usually stated. Presumably the practitioners of the difficult field of epidemiology are no better at reducing unknown errors than are their colleagues in the physical sciences. This suggests that a small effect, which would just be considered significant if only statistical sampling errors are included, should be considered insignificant if other systematic and unsuspected errors are included. 34 The American Physical Society in the Spring of 1995 issued a formal statement declaring that "The scientific literature and the reports of reviews by other panels show no consistent, significant link between cancer and power line fields... While it is impossible to prove that no deleterious health effects occur from exposure to any environmental factor, it is necessary to demonstrate a consistent, significant, and causal relationship before one can conclude that such effects do occur. From this standpoint, the conjectures relating cancer to power line fields have not been scientifically substantiated." (Council of Am. Physical Society, Power Line Fields and Public Health (April 1995).) The American Medical Association (AMA) likewise adopted a policy statement declaring that the association "will continue to monitor developments and issues relating to the effects of electric and magnetic fields, even though no scientifically documented health risk has been associated with the usually occurring levels of electromagnetic fields; (AMA Policy Compendium (1995) Policy No , emphasis supplied). 33 The most recent example is shown in A. I. Shlyakhter, "An Improved Framework for Uncertainty Analysis: Accounting for Unsuspected Errors" 14 Risk Analysis (1994); see also A.I. Shlyakhter, "Uncertainty Estimation in Scientific Models: Lessons from Trends in Physical Measurements, Population Studies and Energy projections" in B.Y. Ayyub and M.M. Gupta, eds., Uncertainty Modelling and Analysis: Theory and Applications (1994). The measurement of physical constants has improved so rapidly in the last 30 years that it is possible to imagine oneself in 1970, considering what is the "true" result of a measurement; the 1995 measurement may have 5 times the quoted precision, and can be considered "true." Then one can ask "How well did the experimenters in 1970 estimate their errors?" The answer, not surprisingly, is not as well as they thought. Shlyakhter showed further that the degree of underestimation of errors has remained roughly constant over the years. 34 The American Physical Society is a nonprofit scientific and educational organization. It is the principal membership body of physicists in the United States, representing over 43,000 physicists in academia, industry, and government. 20

21 The most recent study, by the Committee on the Possible Effects of Electromagnetic Fields on Biologic Systems of the National Research Council of the National Academy of Sciences, prepared at the request of the United States Congress in 1991 and issued October 31, 1996, is a comprehensive examination and evaluation of approximately 500 published studies relating to the effects of power-frequency electric and magnetic fields on cells, tissues and organisms (human and non-human). That study concluded that [T]he current body of evidence does not show that exposure to these fields presents a human-health hazard. Specifically, no conclusive and consistent evidence shows that exposures to residential electric and magnetic fields causes cancer, adverse neurobehavioral effects, or reproductive or developmental effects. National Research Council of the National Academy of Sciences, "Possible Health Effects of Exposure to Residential Electric and Magnetic Fields" at 1 (1996)(hereafter the "NRC Study") (emphasis supplied). The NRC Study continued, "In the aggregate, epidemiologic evidence does not support possible associations of magnetic fields with adult cancers, pregnancy outcome, neurobehavioral disorders, and childhood cancers other than leukemia." (Id. at 3)(emphasis supplied). B. The Epidemiological Principles Since it is the epidemiological evidence that is at the root of the recent concerns, it seems worthwhile reviewing that evidence in light of scientific principles that are used to evaluate whether a statistical association that is found should be considered to be causal. Sir Austin Bradford Hill 35 in his Presidential Address to the Section of Occupational Medicine of the Royal Society of Medicine (U.K.) suggested such a list of "attributes" of the association to be considered: 1. Strength 35 A.B. Hill, "The Environment and Diseases: Association and Causation", 58 Proc. Royal Soc. Med., Sec. Occup. Med (1965). 21

22 2. Consistency 3. Specificity 4. Temporality 5. Biological gradient 6. Plausibility 7. Coherence 8. Experiment 9. Analogy The "strength" of the association was most convincing in Percival Pott's original observation a century and more ago that almost all chimney sweeps developed scrotum cancer. (Risk Ratio very large). Little other evidence seemed necessary. But even for cigarette smoking, where the Risk Ratio is over 10, it was many decades before scientists were convinced of the causal connection. 36 Although the "ecological" studies started by Wertheimer and Leeper showed a Risk Ratio 37 of about 2.28, the statistical significance was marginal. As noted above, Washburn, et al. find a Risk Ratio of 1.57 for some sort of association with the presence of power lines which is statistically significant. We emphasize the difference between the standard practice in epidemiology and the standard practice in the physical sciences. Physical scientists routinely discuss non-statistical and systematic errors in great detail, and usually attempt a quantitative description of them. Epidemiologists sometimes discuss the non-statistical errors in the text, but do not make a 38 quantitative estimation or include the qualifying phrases in the abstract of an article. Great caution 36 Wertheimer and Leeper, supra note Washburn, et al., supra note 10. See supra note

23 is necessary in any interpretation of these numbers, especially when the effect is small. We note that the reduction in Risk Ratio from 2.28 to 1.57 is a two fold reduction in predicted excess cancers since the excess cancers are proportional to (Risk Ratio -1). This is the type of reduction we would observe because of the fact that some of the cases were known before the study started (the "Feynman Trap"). Although a few of the occupational studies listed in the ORAU report, and others that have appeared since, have high Risk Ratios which, by themselves, seem statistically significant, the average is much closer to unity. If the average found in either the ecological studies or the occupational studies were found in a single study, the Risk Ratio of 1.57 would not normally be considered large enough to be deemed evidence for a causal relationship. Of situations where the measured Risk Ratio is less than 2, only two have been accepted as evidence of harm, and these are special situations. The effects of 39 tobacco smoke on the families of smokers (with an average 19% increase or a Risk Ratio of about ) have been accepted by the Environmental Protection Agency, and by many physicians and scientists: this is because tobacco smoke is known to be hazardous to the smoker who has a large 41 dose. Likewise it is generally accepted that there is an effect of X-rays during pregnancy on the probability of childhood leukemia, even though the Risk Ratio averaged over studies is less than 39 As distinct from the much higher Risk Ratio for smokers themselves. 40 Almost the whole issue of Risk Analysis (February 1995) is devoted to articles on this subject. 41 However, some scientists still question the evidence with respect to the families of smokers because there are problems with the measured amount of smoke and they believe the EPA acceptance to be entirely political. 23

24 42 43 two, because at high level exposure radiation does clearly cause cancer. But there is no intensity or situation where electromagnetic fields are known to cause cancer, so one cannot argue that the existence of an effect in a higher intensity field reduces the standard of proof of causation for lower intensity fields. A recent article in Science discusses problems with accepting epidemiological 44 studies with a small risk ratio. Hill's Attribute 2 asks whether "the same result has been repeatedly observed by different 45 persons, in different places, circumstances and times." The record is mixed. The initial observation that excess childhood leukemias are observed near power lines has been repeated a few times, and there seems to be a consistent relationship with proximity to power lines, but not with the 46 measured magnetic field itself. The Swedish residential study is consistent with earlier studies in that no association was found with fields measured contemporaneously, but since no one else calculated fields from wire codes and historical usage, the statistically significant result here cannot be properly said to be completely consistent with earlier data. Consistency is also related to the next Attribute, specificity. As noted earlier it is not enough for successive studies to find that cancer is elevated in the presence of electromagnetic fields. The Feychting and Ahlbom study suggested that magnetic fields cause an increase in Acute Lymphocytic Leukemia but not in Chronic Lymphocytic Leukemia, whereas the study by Floderus, et al. showed 42 A. Stewart and G.W. Kneale, "Radiation Dose Effects in Relation to Obstetric X-rays and Childhood Cancers," Lancet 1185 (June 6, 1970). 43 There are numerous reviews on this subject. We refer in particular to the reports (particularly that of 1993) of the United Nations Subcommittee on the Effects of Atomic Radiation (UNSCEAR) to the General Assembly, United Nations (1993) G. Taubes, "Epidemiology Faces Its Limits," 269 Science 164 (July 14, 1995). A.B. Hill, supra note 29. Feychting and Ahlbom, supra note

25 47 an increase in CLL, but not ALL. The most recent study by Savitz and Loomis shows no increase in any leukemia, but a small increase in brain cancer! Moreover the residential studies show no increases in adults, and only effects in children are claimed. These studies are not consistent and do not confirm each other. Attribute 3 emphasizes that "if the association is limited to specific workers and to particular sites and types of disease, and there is no association between the (postulated cause) and other modes 48 of dying, then clearly there is a strong argument in favor of causation." This Attribute must be interpreted with full understanding of the generality of the exposure mechanisms. Unlike chemical carcinogens, which give the dose at well defined parts of the body, electromagnetic fields might well affect all parts of it. In this respect, and this respect only, the problem might be similar to external gamma radiation, which affects all parts of the body. This Attribute might, at first sight, be considered not to apply at all. However, if electromagnetic fields produce several types of cancer in one group of people, they should produce the same types of cancer in similar proportions in all other groups similarly exposed. 49 Attribute 4 demands that the adverse outcome occur after the postulated cause by whatever delay (latent period) has been seen in other studies, or is reasonable from biological principles. In 50 other words, "Which is the cart and which the horse?" In the existing epidemiological studies, the cancer incidence has not been associated with a contemporaneously measured electromagnetic field, 47 D.A. Savitz and D. Loomis, "Leukemia and Brain Cancer in Electrical Workers" 141 Am. J. Epidemiology (1995). 48 A. B. Hill, supra note Exact agreement about the proportions is not necessary here, because they may be modified by synergistic factors, and by the different age or gender distributions of the populations. 50 A.B. Hill, note 29, supra. 25

26 in spite of searches for an association, nor has it been possible to associate incidence with a field measured at an earlier time, because of an inability to get data. Instead, the association is with a field assumed, or calculated, from configurations of high tension transmission and local distribution wires. A very important anchor for epidemiologists is Attribute 5 on Hill's list -- the existence of a biological gradient or dose response relationship. In the usual models, "more is worse" and "less is better," and the adverse effect is at least proportional to the exposure if it does not rise faster than proportionality suggests. There is no accepted medical effect of a pollutant where the effect does not increase as the dose increases, at least initially. The effect of magnetic fields on cells is expected, 2 51 on general symmetry principles, to vary as the square of the field (B ) at low fields. This dependence arises because the magnetic field comes from the motion of electric charges rather than from the charges themselves, and it is not sensible to envisage that cancer incidence changes sign (from plus to minus) as the magnetic field changes sign. When one considers alternating fields, the 52 principle is even more general. Electric power lines produce magnetic fields of 3 milligauss or less in nearby houses. A study of Norwegian railroad workers (who work on an electric railroad with 53 exposure to approximately 30 milligauss fields) showed no effect. Electric blankets used to give still larger fields (300 milligauss) before they were made with twisted pair wire, but epidemiological studies of people who used older-type blankets have not shown a very large effect, even though the general argument suggests that the effect should be 10,000 times greater than the effect on residents exposed to 3 milligauss fields. The initial epidemiological study on the effects of electric blanket 51 This must be the total magnetic field, including the earth's magnetic field. 52 R.K. Adair, "Biological Responses to Weak 60Hz Fields Must Vary as the Square of the Field Strength," 91 Proc. Nat. Acad. Sci (1994). 53 T. Tynes, et al., "Leukemia and Brain Tumors in Norwegian Railway Workers, A Nested Case Control Study", 137 Am. J. Epidemiology (1994). 26