Reports


Method for Detecting Changes in Systems Governed by Nonlinear Laws

Fig3

A serious impediment to recognition of the impact of environmental EMFs on human health involves the cognitive structure within which most studies are designed. Typically, investigators assume that any real response triggered in a subject exposed to an EMF must be reproducible. Reproducibility is indeed the imprimatur of causality in science. But what must be reproduced?

A common assumption is that the numerical value of the measured effect is the requisite reproducible observation. If a putative effect is +50 units, “reproducibility” is taken to mean that +50 units must be observed when the putative cause is reproduced or, allowing for the apparent stochastic variability exhibited by living systems, at least something close to +50 units. Under this assumption, an observation of 0 units or −50 units counts as evidence against a causal link, and observation of −50, 0, and +50 in three independent trials would be interpreted as strong evidence against the reality of the effect, based on averaging. But adoption of this assumption in a one-size-fits-all manner emasculates our ability to understand nonlinear biological phenomena, for example those caused by EMFs. To see this, suppose that +50 and −50 were each observed five times in ten independent trials, an entirely permissible result in a fully deterministic system governed by nonlinear laws (nonlinear differential equations). Under the common assumption, a strong inference against the existence of an effect would arise because the data averaged to zero. Nevertheless the results were reproducible in the sense that they were consistently non-zero. Suppose the analytical method used to evaluate the data obtained in the ten trials returned a positive value each time the putative cause was applied, regardless of whether the measurement yielded +50 or −50. In this case the cause-effect relationship would be captured by the analysis and the scientific requirement of reproducibility would be satisfied. The biological effects of environmental EMFs must be viewed from this perspective of nonlinearity. Otherwise the chronic error of the power and cell-phone companiesóthe false negative resultówill continue to occur, with all the harm that the error entails. The nonlinear perspective would permit rationalization of causality based on the frequency of the kind of observation made (consistently non-zero), not on the arbitrary (and certainly wrong) assumption that a non-zero average of the magnitude of the observation is a necessary property of reproducibility.

I developed and patented a method for analyzing data reveals effects even when traditional linear methods fail to do so. The method applies to any nonlinear time series data obtained from any biological source. I used it principally to detect the effects of EMFs on brain electrical activity as measured using an electroencephalogram.

Download a PDF of the patent.

 

Scientific Evidence in Cases Involving Electromagnetic Fields

Historically, the law has struggled to formulate rules of evidence for governing scientific testimony. The issue was resolved at the federal and, in many cases, state levels when special rules of evidence were adopted and then interpreted by the Supreme Court in Daubert v. Merrill Dow. Unfortunately, the problem is still unresolved at the effector level, where cases are tried and decisions are made that involve scientific issues. Firms that represent power companies and cell-phone companies adopted an organized, coherent strategy and database for attacking scientific testimony offered by plaintiffs. The plaintiffs’ bar, in contrast, is disorganized, incoherent, and capable only of ad hoc strategies that invariably make little sense, either legally or scientifically. Plaintiffs’ mega-firms have sometimes succeeded in high-profile cases, such as those involving cigarettes and asbestos, but they have failed even more spectacularly in other cases because their strategies were inconsistent with modern scientific jurisprudence. I discussed the underlying issues in a law review article entitled “The Scientific Basis of Causality in Toxic Tort Cases.” The analysis and conclusions reached there are as applicable in 2011 as they were in 1995 when the article was published.

EMF plaintiffs are still waiting for an economically powerful lawyer who understands how to use the post-Daubert rules governing scientific evidence. The rewards for the plaintiffs, lawyers, and society will be great. The losers will be the companies. For a deeper discussion of what the lawyers must do to win, see chapters 28 and 29 in Going Somewhere.

Read the full article.
Download the PDF.

 

Hazards of High-Voltage Powerlines: The Beginning

NYC PSC

In July, 1974 I was asked by the state of New York Public Service Commission (PSC) to testify in a hearing on the safety of high-voltage powerlines regarding what I perceived to be their health risks. Dr. Robert Becker, who was my chief, and I submitted written testimony that was served on the power companies in October, 1974 (Read testimony Becker-1; Marino-1).

The reports of experts hired by the power companies were distributed in November, 1975; at the time the PSC served the companies with an updated version of our testimonies (Read testimony Becker-2; Marino-2).

In 1976 Dr. Becker was cross-examined by the companies for 4 days and I was cross-examined for 10 days. The companies then served rebuttal testimony in which their experts attacked our testimonies. In response, the PSC served the companies with my rebuttal testimony in which I attacked their experts (Read testimony Marino-3). I was cross-examined for 3 additional days.

After the testimony phase of the hearing was finished, lawyers for the power companies and for the staff of the Public Service Commission filed legal briefs in an attempt to persuade the Commission that their respective views of the evidence were correct. The brief of the staff of the PSC argued that powerline electromagnetic fields would affect human health, but I thought a stronger position was warranted. Consequently, representing myself, I submitted a legal brief in the summer of 1977 in which I summarized the scientific evidence and drew legal conclusions (Read brief Marino-4).

The lawyers for the companies submitted a brief in which they attacked my brief. Consequently, in September, 1977 I submitted a reply brief which attacked their brief (Read brief Marino-5).

The PSC procedure allowed still another round of briefs, so in February, 1978 I submitted a brief on exceptions (Read brief Marino-6).

 

Michael Repacholi: SOB at WHO

SOB

In 1996 the World Health Organization began what it said was a project “to assess the scientific evidence of possible health effects of EMFs in the frequency range from 0 to 300 GHz” (EMF Project). But the project was corrupted from the start because it was controlled by the power- and cell-phone companies in the industrialized countries. The companies designated Michael Repacholi as the project head. For many years he had been a consultant and spokesman for power companies, so it was not realistic to expect that he would conduct an open and honest inquiry. But his performance in office was even more miserable than could have been anticipated based on what had been known about his personal opinions when he was appointed.

During the time he headed the EMF project at WHO, Repacholi dealt almost exclusively with experts on the payroll of cell-phone and power companies. He produced a series of reports and evaluations that exonerated these industries from any responsibility for human disease produced by the EMFs they generated and dispersed into the environment. Scientists who disagreed with the viewpoint of the EMF companies were systematically excluded from the WHO EMF adjudicatory process. The general public, a major stakeholder in the EMF debate, had no representation at the table when Repocholi’s committees broadly sanctioned widespread EMF exposure. Instead, the WHO scientific reviews of EMFs were star-chamber processes in which only pro-industry spokesmen were heard, and the results of the processes were foreordained.

Repacholi gave many speeches but was never held accountable in any serious dialogue or debate, and was never required to justify his extreme positions. He invariably appeared in forums that were friendly to his mission, and under conditions that insulated him from the necessity for reasoned discussion. I saw him at the Annual Meeting of the Bioelectromagnetics Society (BEMS) in Cancun, Mexico, in June, 2006. The Mobile Manufacturers Forum, which consists of the world’s major manufacturers of cellular telephones were “Gold Sponsors” of the BEMS meeting, and the leaders of BEMS had invited Repacholi to give a talk entitled “Results from 10 Years of WHO’s International EMF Project,” which he delivered at a plenary session at the meeting. Only children can believe that the invitation to Repacholi to present the talk was unrelated to the “Gold” sponsorship of the meeting by the companies that Repacholi had so vigorously supported for the last decade.

Unsurprisingly, his talk was a paean to the activities at the WHO that he had guided and controlled. He was proud of having successfully stemmed the tide of concern regarding the propensity of environmental EMFs to produce cancer and other human diseases, and of having defended the principle that man-made environmental EMFs were harmless. He touted model legislation that he had drafted, and said that he hoped it would be enacted by various governments so that the fact that environmental fields were safe would be enshrined in law.

At the end of his talk I rose and said, “Dr. Repacholi, I’m Andrew Marino from Shreveport, Louisiana. When you say that WHO assessed research about EMFs, can you tell us exactly who at WHO did that assessing?” He began his answer by describing a formal process for considering scientific evidence, but without naming names. I interrupted him. “Perhaps I wasn’t clear. I didn’t ask what the process was from a procedural point-of-view. I would like to know the names of the human beings who make the judgments regarding the safety of environmental EMFs.”

Again, his answer was evasive in the sense that it dealt with process and did not name names. I interrupted again and said, “I am trying to get at the names of the individuals, the human beings who made the judgments of EMF safety that are contained in the WHO reports. Will you please tell me their names?”

For a third time, he refused to answer, and for good reason. Any names he listed would have been immediately recognizable as paid consultants or employees of the EMF-producing industries, including himself.

Using his bully pulpit at WHO, Repacholi encouraged human beings, including young children, to chronically irradiate their brains with electromagnetic fields by falsely proclaiming that they were safe. He therefore bears direct personal responsibility for many cases of human disease. He is not the most evil man I met in my life, but he is in the top three.

For a detailed analysis of each of Repacholi’s sophistical EMF arguments, click here to read my detailed comments regarding testimony he gave in Australia concerning the health hazards of high-voltage powerlines.

 

Health Hazards of Powerline Electromagnetic Fields: A Mid-Career Memoir Written in 1995

Bugler

Origins

The question whether powerline electromagnetic fields (EMFs) affect human health originated in the 1960s in the United States, and some time earlier in the Soviet Union. I first became aware of the question in late 1973, during a conversation with Robert O. Becker, M.D., who was my mentor when I was a graduate student (1963–68) and my chief for 12 years thereafter.

During 1974–1978, Dr. Becker and I were deeply involved in a long legal dispute in New York regarding whether powerline EMFs were a potential health hazard. In the subsequent quarter century, concern regarding health risks of powerline EMFs grew and expanded to other sources of electromagnetic fields in the environment including cellular telephones, microwave ovens, electric blankets, microwave towers, and television and radio antennas.

I did not anticipate the firestorm of controversy that was birthed by our testimony in New York nor, I think, did Dr. Becker. I was a young Ph.D. in biophysics, and a still younger lawyer, largely inexperienced in the intricacies of both professions. Dr. Becker had been involved in scientific arguments but that experience did not prepare him for the contentiousness which subsequently developed regarding powerline EMFs.
Read more…

 

The NIEHS RAPID Program: Anatomy of Failure

Portier

The NIEHS RAPID program was created by Congress to assess whether the electromagnetic fields (EMFs) from high-voltage powerlines caused or contributed to cancer in people exposed to the EMFs. Dr. Kenneth Olden, the Director of NIEHS, assigned the task to Christopher Portier. In 1998, I served on three of the NIEHS blue-ribbon committees at a meeting he held for the ostensible purpose of helping him identify the correct answer to the question posed by Congress. During and soon after the meeting I dictated notes to capture how the committees functioned and how decisions were being made. The notes contain my opinions because their incorporation was integral to the process by which I made meaning of what I saw.
Read the notes.

 

Powerline-EMF Hazards: Wellspring of the Controversy

Wellspring

Passionate disagreements exist regarding numerous issues that involve science. The issue that has always interested me the most is the safety-of-factor-X problem, where X is man-made environmental electromagnetic fields (EMFs).

I began studying the issue in the early 1970s. At that time, earlier concern regarding the health of servicemen who had been exposed to EMFs from military radar and communications equipment had ended, and scarcely a ripple of interest remained in the public or scientific consciousness. The bell curve for concern regarding leakage of EMFs from microwave ovens had already crested, and it looked very much as if that putative problem would soon be put to rest. Publicity about hazards and risks from EMFs produced by high-voltage powerlines was just beginning.

The time interval during which the public was interested in powerline EMFs can be bracketed between 1974, which was when the New York State Public Service Commission became the first government authority to formally consider the question, and 1998 when the prestigious NIEHS answered the question in the negative. At about that time the cycle began again with cell telephones. Do their EMFs cause brain cancer and other diseases?

I was a serious and dedicated student of the physics, biology, sociology, and legal structure of the debate concerning the relation between powerline EMFs and health risks for the entire duration that the issue was in the public eye. From my perspective on the decision by NIEHS (The NIEHS RAPID Program: Anatomy of a Failure) was a false negative decision, so in 1998 I set about trying to explain how it came about. I thought my insights might help guard against a repeat of the cycle in the context of cell-phone EMFs.

What I wrote in 1998 was honest, even though I did not fully understand the extent to which science can be corrupted by money, or how little most people care about the impact of the man-made environment on their health, at least in cases where recognition of a serious risk would entail a modification in lifestyle. I avoided cheap shots against the government. Clearly the NIEHS failed to warn the public about the dangers of EMFs, but the fault does not lie with the agency because it functioned exactly as intended by Congress. Its job was not to protect people against the side-effects of their pleasures, nor to conduct research that could lead to results supporting let’s-regulate-cell-phones groups. I sought the deep reasons why NIEHS could claim that powerline EMFs were safe, and get away with it.

At the end of my inquiry, what I found was that any answer to the question whether EMFs from high-voltage powerlines were health hazards would be heavily value-laden. Consequently, non-representative blue-ribbon committees and politically sensitive government agencies are intrinsically unable to provide meaningful answers. My experience with health hazards from cell-phone EMFs leads me to conclude that the powerline analysis and conclusion also apply to cell phones.

Click here to read the 1998 report.

 

PARTIZANIST DISCRIMINATION IN CALIFORNIA FAVORS ELECTRIC POWER COMPANIES

partisans

JOURNAL OF BIOELECTRICITY, 9(2), v–vii (1990)

EDITORIAL

The California Public Utilities Commission (PUC) sent a report to the California legislature (Potential Health Effects of Electric and Magnetic Fields from Electric Power Facilities, September, 1989), in which it concluded that powerline electromagnetic fields (EMFs) did not cause cancer or other medical problems, and that exposure standards were unwarranted. The whole argument rests on a set of false assumptions. First is the assumption that there is such a thing as a cause of disease. There isn’t. A cause is a condition “that effectively and inevitably calls forth an issue.” Moreover, “it should be obvious” that the condition is the “immediate agent in the production of an effect.” The core meaning of cause is conveyed by the philosophical efficient cause or the legal proximate cause. Correct usage of cause allows a little weakening in the timing and inevitability of the relationship between the “condition” and the “issue”—but not too much. Suppose, for example, that 100 lawyers were dropped off the roof of a 10–story building. We expect a high mortality, and we could conclude that falling from the top of a 10–story building caused lawyers to die; cause would be appropriate even if only 99 of the lawyers died. Suppose 100 other lawyers were dropped off the roof of a 3–story building, and only 50% died immediately. We could conclude that a 3–story fall can cause lawyers to die, and we could even estimate the probability of the event. Clearly, death was caused not only by the fall itself—because not every falling lawyer died—but, additionally, by unascertained “conditions” in the way the lawyers fell. Perhaps there was a higher mortality among the lawyers that landed on their heads, or among the wealthy lawyers (because wealth was correlated with a death-promoting characteristic such as poor physical health). Replicates of the second experiment aimed at more precisely defining the cause of death would be worthwhile, but replicates of the first study would probably be a waste of lawyers. Consider the fate of the lawyers who survived. Many of them spent a long time in surgical intensive care units, where they were maintained supine and fed via a plastic tube; iatrogenic infections and multiple organ failure were common. Twenty years later, it was found that the incidence of leukemia among the survivors was twice that of a control group. Can we say that the fall caused cancer? Surely not, if cause has its correct meaning. The California legislature seems to have understood this point: The law that ordered the PUC study speaks of the possibility that EMFs may be “associated” or “related” to disease—pointedly, it does not use “cause.” The second false assumption is that until someone shows that EMF disease is subserved by a specific molecular mechanism that can be thwarted by changes in powerline design, the appropriate regulatory action is to do nothing. The appropriate action is that which is fair and nondiscriminatory—molecular mechanisms are irrelevant to the issue. We do not understand the molecular mechanism of memory, digestion, or life, and yet we do not ignore their reality. We do not understand the molecular mechanism of cancer induction by cigarettes, asbestos, or ionizing radiation, and yet we do not fail to regulate them. Courts routinely make decisions on the basis of less-than-perfect information, and there is no legal, logical or scientific principle that compels non-action in the presence of uncertainty. Any decision has its potential down side. If design changes are made and EMF exposure ultimately turns out to be non-hazardous, then money will have been wasted. But failure to act coupled with the reality of EMF health risks means that some luckless subjects would have developed disease that could have been avoided. The right and responsibility to decide rests with the people because, in a democracy, social policy is determined by the people, not by a technically specialized commission in the executive branch of government. The PUC—which is not a representative body—has arbitrarily chosen to discriminate in favor of a partizan group (utility companies) over the interests of all others.

The third false assumption is that the environmental hazard posed by EMFs “is not testable by scientific methods.” It is—if one has the heart, brains, and money. The stressor hypothesis of EMF-induced disease holds that the EMFs result in conformational changes in membrane-bound electrogenic proteins which alter the local membrane potential resulting, ultimately, in the propagation of a signal along a pathway projecting to the thalamus. The afferent signal triggers multiple efferent signals to the immune, endocrine, and central nervous systems. Continuous activation of these pathways (chronic EMF exposure) increases the probability for disease (compared to non-continuous activation) via decreased efficiency of immune surveillance. Each aspect of the hypothesis is directly testable. The effect of EMFs on membrane potentials and proteins can be studied using patch-clamp techniques. The existence of simultaneous afferent and efferent signals in the central nervous system as a consequence of EMF exposure can be proved or disproved using spectral analysis of the electroencephalogram. Promotion of an immune-system deficit can be studied by measuring the effects of EMF exposure on the functional and kinetic properties of natural killer cells. The disease exacerbating effects of chronic EMF exposure can be studied in animal tumor models in which typical endpoints (mean survival time, extent of metastases, threshold, innoculum) are studied as a function of field exposure.

Like the conclusion reached by Zeno denying the reality of motion, the PUC’s conclusions are logical consequences of its assumptions. What accounts for the PUC’s subtle fallacies? PUCs arose as a legislative response to the problem of siting powerlines and setting rates. Prior to their emergence, local governments enacted myriad inconsistent regulations regarding powerlines, and no system of checks-and-balances existed to restrain monopolistic greed. When the EMF health issue appeared in the 1970s, most states assigned jurisdiction of the problem to their PUCs. Unfortunately, the PUCs possessed no expertise or tradition in dealing with health-related issues. Even worse, since a revolving door frequently existed between the PUCs and the industry, individual commission members and staff showed little interest in taking remedial steps.

The issue of EMF health risks belongs squarely within the jurisdiction of the state agency concerned with other environmental pollutants-not within the purview of the PUC or the Health Department (which is usually geared to study infectious disease). The choice regarding discrimination on the basis of partizan status should be made by the legislature, and then implemented by an executive agency having the requisite mandate, resources, and independence from the polluter.

Andrew A. Marino

 

BEAUTY AND A BEAST

King Kong

JOURNAL OF BIOELECTRICITY , 9 (1), v–vi (1990)

EDITORIAL

In 1925, a broker was hired to sell a building in New York. Through a dummy corporation, the broker himself made an offer of $80,000 and the client accepted. When the corporation resold the property a few weeks later for $87,500, the client suspected hanky-panky and sued; ultimately, the case came before Justice Cardozo. First, Cardozo pointed to the obvious conflict-of-interest: A broker’s duty is to get the highest price, but a buyer’s goal is the opposite. The broker claimed that he revealed enough information when he told his client that the corporation was also a client. Not good enough, said Cardozo, and he laid down the rule regarding disclosure that applies to anyone who owes divided fealty: “If dual interests are to be served, the disclosure to be effective must lay bare the truth, without ambiguity or reservation, in all its stark significance.”

Electric power companies must supply power and earn a profit—but also, they must safeguard those exposed to powerline electromagnetic fields (EMFs). In serving these dual interests, they are required to “lay bare the truth” regarding EMF bioeffects. Have they?

There was no disclosure about a $0.5-million animal study (Johns Hopkins) that apparently corroborated Soviet EMF observations. Similarly, there was no disclosure about EMF epidemiological studies in 1976 (Equitable Environmental Health, Inc.) and 1980 (Tabershaw Occupational Medicine Associates). No results appeared from a $4 million study (Southwest Research Institute) that related EMF effects in baboons to humans, or from rat studies (University of Rochester) designed to replicate reports that showed EMF bioeffects. In these and other cases, the records of the studies including the study plans, statistical design, results, and evaluation apparently got the deep six. The industry has argued that its secret research was unscientific, and hence not worth disclosing. The premise may be true, but the conclusion is a non sequitur. The concession that the industry bought poor science argues that all industry studies should be completely disclosed (so that we can make up our own minds about the scientific merit), not that some studies may be completely withheld. The Battelle studies, however, exemplify what usually happens—partial disclosure.

EMF work at Battelle commenced around 1975, and has probably cost more than $50 million; its apparent purpose was to overcome animal studies cited against the industry in hearings in New York. The data obtained during the first several years of the work was either irrelevant or actually adverse to power-company interests, and in mid-stream the studies were retargeted to impeach themselves. The Pig Study had more false starts and design changes than one can sensibly analyze, the Three-Generation Mouse study became a four-generation experiment, and a Fracture Healing study in rats was repeatedly replicated. One can indeed find reports concerning the work at Battelle, but the truth in them is thin. By making controlled partial disclosure, the industry sustained the appearance that the Battelle studies are unimportant and inconclusive.

The industry’s off the-record argument is that disclosure “in all its stark significance” would cause panic. Not good enough: The benefit to the power company of someone living beside its powerline not getting cancer is a lot less than the benefit to that person of not getting cancer. This difference in risk-benefit status can affect one’s view of EMF studies, but, banal as it may sound, one cannot consider undisclosed data.

Power companies and their EMF investigators are tightly linked by contractual privity. There is no revealed, disinterested peer group that judges scientific merit (as with NIH grants), and no freedom-of-information law requires disclosure of research plans or data. Power companies spend hundreds of millions of dollars for EMF research, but only the information they choose is released, usually after it has been treated by their spin doctors.

How do they get away with it? One afternoon, an industry spokesman told a court that he had been asked to do EMF research. The proposed work was grossly inconsistent with his testimony, and an exasperated judge asked for an explanation: “He who has the gold, makes the rules,” was the reply. This beastly apophthegm, not the beauty of Cardozo, is the reigning rule regarding industry research. The industry product should therefore be properly labeled: WARNING: RESEARCH PAID FOR BY THE ELECTRIC POWER INDUSTRY—THE RESULTS MAY BE HAZARDOUS TO YOUR HEALTH.

Andrew A. Marino

 

TRUST ME, I’M A DOCTOR

Lucky Strikes

JOURNAL OF BIOELECTRICITY, 8(2), v–vi (1989)

EDITORIAL

During a recent legal proceeding in Canada involving health hazards of powerlines, Linda Erdreich testified for the power company. Based on an analysis of “every study that could be considered as relevant to this Inquiry,” she said that the powerline electric and magnetic fields posed no risk to human health. The essence of her position was that we could have faith in her knowledge of bioelectricity and her integrity as an independent scientist. Erdreich’s schoolteacher manner and neat appearance meshed well with her testimony, and altogether they said this: I’m a doctor, trust me, these powerlines are safe.

After obtaining a Ph.D. in epidemiology, Erdreich worked 7 years at Reagan’s Environmental Protection Agency performing risk assessments for toxic chemicals and waste dumps. About 6 weeks prior to her testimony, she was hired by Energy Research Associates, Incorporated (ERI). The power company hired ERI, which sent Erdreich to Canada to testify.

Erdreich conceded that she didn’t know the difference between an electric field and a magnetic field, and that she had begun her studies in bioelectricity only after taking the ERI job. Her written report, however, was a polished collection of half-truths which evinced a degree of rhetorical sophistication beyond that of a neophyte. Clearly, the words and method of analysis used by Erdreich were in ERI’s word processor prior to her employment. Who, then, is ERI?

The effort to assuage public concern over powerlines has spawned significant economic activity in the penumbra of the power industry: Someone from the power-industry orbit starts a company and it soon becomes favored with industry business. These companies provide many services including contract research, risk analysis, and what is euphemistically called education of the public. ERI, a privately held New York-based consulting company, is a good example: One of its owners is Robert Kavet, who for many years was an important executive at the Electric Power Research Institute. He participated in the award of millions of dollars for research ostensibly geared toward evaluating the health-risk issue. Now, his company is on the receiving end of the flow of industry dollars.

ERI is a metastasis of a chronic power-industry disease—the use of dollars to buy science that will support corporate decisions in the face of contrary data. Perhaps ERI is entitled to sell, and the power companies are entitled to spend their dollars in any manner they choose. There is no entitlement, however, to hide one’s role in a scenario. It would not have been credible for Kavet to give Erdreich’s testimony: Erdreich-Kavet’s new employee-would have seemed even less credible if these links had been disclosed.

The public has an absolute right to know who bought and paid for the goods and services that are being used to try and persuade them. ERI urges the truth of a proposition, and it is in its economic interest to do so. The appropriate model for this activity is not the doctor, who acts on our behalf, but the salesman, who acts on his own behalf.

Andrew A. Marino

 

Basic Competency Examination

NEGATIVE STUDIES AND COMMON SENSE

journals

JOURNAL OF BIOELECTRICITY, 8(1), v–vii (1989)

EDITORIAL

During a recent trial in Florida, Phillip Cole, Chairman of the Department of Epidemiology, University of Alabama, testified regarding health risks due to chronic exposure to powerline electromagnetic fields. There are 19 studies, he said, that reported associations between disease and a surrogate for exposure, but there are 11 studies that did not report such an association. Cole doubted the validity of the positive studies because there were 80 many negative studies. Furthermore, the positive studies were “implausible” because he knew of no reason that electromagnetic fields should cause physiological changes. Consequently, Cole opined, children exposed to powerline fields would not experience increased risk of disease.

Cole’s approach dovetails nicely with the position of the national power industry. If negative studies do indeed balance out positive studies, then a convenient trap door exists to escape liability and responsibility for the disease-promoting aspects of their activities. This is one plan: Award a contract to a research-for-hire laboratory or a university professor willing to play ball, and specifically define the desired research. For example, provide that only very old rats shall be studied, thereby minimizing the possibility that specific neuroendocrine variables will exhibit a sustained response to an impressed field. Or, require that the experiment be performed in animal cages 40% smaller than normal. Since both the exposed and control animals will be significantly stressed by confinement, the possibility of observing a stressor response caused by the field will be minimized. Another strategy involves the method of data analysis: Suppose the sponsor requires that the dependent variable exhibit a dose-effect relationship with field intensity as a condition precedent to the acceptance of the occurrence of a field-induced effect. If the dependent parameter is altered (compared to the control) at all field intensities studied, but does not exhibit a linear relationship with intensity, it can be concluded that no effect was observed. Entering into a contract with an inept scientist is another method for bringing about negative studies. Ignorance then becomes a virtue for the sponsor because there is only a minimal possibility that useful information will be obtained. If anyone doubts that this overall strategy actually exists, let him explain the plethora of industry-bankrolled negative studies.

Every worthwhile scientific study is performed to test a hypothesis: The experimental hypothesis relates to the meat-and- potatoes of the study, but it is the statistical hypothesis that is formally tested. This statistical (null) hypothesis asserts that the mean values of the dependent variable in the experimental and control groups are identical. When this occurs, we conclude that the null hypothesis has not been disproved, and thus that the experiment produced no evidence to indicate that the independent variable affected the dependent variable. This is essentially what is meant by a negative study, and it has been elevated by Cole and his colleagues who speak for the industry to the level of an affirmative finding. But a negative study suggests only that, under the precise conditions and limitations of the experiment, the dependent and independent variables were probably not related. Such a study, however, is utterly silent regarding the relationship of the variables under conditions not studied. As Edwin Carstensen (certainly no friend of those who believe powerlines create health risks) observed during his testimony in New York in 1976, “a negative study may simply mean that the investigator looked for the wrong thing in the wrong place at the wrong time.” There is only one small window of relevance for negative studies: If two studies performed under identical conditions reach opposite results, then the true behavior of nature under those conditions is uncertain. But replications are rare; none of the 11 negative studies employed by Cole to undercut the 19 positive studies, for example, could honestly be said to be a replication of a positive study. All 30 studies were different. With this narrow exception, it is clear that negative studies have no probative value—any material fact more likely than not of being true. They are simple monuments to failure (whether intentional or otherwise), and do not merit consideration as affirmative data. Texas and Louisiana contain many holes in the ground that yielded no oil. Cole's logic leads to the conclusion that there is no oil, but common sense says that there is no oil in the dry hole—40 feet away, it may be (and frequently is) a different story.

Cole has concluded that there is no truth, and he employs the art of persuasion for the ends he chooses. The good news is that neither the chicanery of a sponsor who seeks to clutter the literature with negative reports, nor the incompetence or avarice of the scientist who cooperates with this effort can actually corrode the structure of science. The careful student of bioelectricity quickly learns to separate poison-pill experiments and sophistry from facts and rational analysis, and to determine which individuals and groups are truly interested in building bioelectricity into a useful and important science, and which are interested in burying the subject under a mountain of innuendo, doubt, and disdain. The bad news is that judges and other generalist laymen, unfamiliar with the concept of the null hypothesis, may be susceptible to the Siren call of the negative study.

Andrew A. Marino

 

WE NEED A SCIENCE COURT

science court

JOURNAL OF BIOELECTRICITY, 4(1), vii–viii (1985)

EDITORIAL

In the late 1960’s the Navy proposed a large antenna (Project Sanguine) to transmit low-frequency electromagnetic fields to submarines. In December 1973, studies of the biological effects of these electromagnetic fields were evaluated by a blue-ribbon panel (BRP), which expressed serious reservations about Sanguine’s safety, and about other similar sources of electromagnetic fields such as high voltage powerlines. When the BRP report (Proceedings of the Ad Hoc Committee for the Review of Biomedical and Ecological Effects of ELF Radiation, Bureau of Medicine and Surgery, Department of the Navy, Washington, D.C., 1973) was released by Senator Gaylord Nelson, the resulting furor led to a second BRP, chosen with more ...care (Science 192, 1213–1215,1976). Its conclusion (Biological Effects of Electric and Magnetic Fields Associated with Proposed Project Seafarer, National Academy of Sciences, Washington, D.C., 1977) was diametrically opposite that of the BRP. The NAS–BRP discounted any possible health risks and gave the Navy a green light, but the controversy continued. Residents of Michigan and Wisconsin who lived near Sanguine’s proposed site apparently had misgivings about the integrity of the adjudicatory process. Did the fact that the Navy orchestrated the NAS–BRP have anything to do with its conclusion?

Recently, the results of still another carefully-chosen BRP (Biological and Human Health Effects of Extremely Low Frequency Electromagnetic Fields, Committee Report, American Institute of Biological Sciences, Arlington, Virginia, 1985)(AIBS–BRP) concluded that it was unlikely that Sanguine’s electromagnetic fields would be a public-health risk. Thus, the BRP box score is 2 to 1, with the anti-risk BRPs in the lead. Does this mean that Sanguine’s electromagnetic fields present no health risk? No. It simply confirms that he who has the gold makes the rules. The AIBS–BRP’s conclusion was obvious when its composition was announced.

There is a better way. We must recognize that the question of the safety of Sanguine (or high-voltage powerlines or microwave ovens or any other source of electromagnetic radiation) is inherently adversarial. The Navy obviously wants the antenna, and it supports the scientists who say that it will be safe. Many scientists disagree with this notion, and the fact that they are routinely excluded from government committees and contracts does not detract from the validity of their position. Scientists on both sides should be allowed to take part in the fact-finding process, and it is they who should pick the judges and procedures. It is perfectly permissible for the experts to have strongly-held views or biases; what matters is the quality and relevance of their evidence, and the clarity and cogency of their logic. The judges however, must be unbiased and must avoid even the appearance of bias. An agent or employee of the Navy or the electric power industry, for example, would not qualify. This concept, the science court (Science 193, 653–656, 1976) follows the same principles and practices for the determination of truth and the pursuit of justice as are practiced in all other spheres in our society.

Andrew A. Marino

 

WHERE IS THE EPA’S SENSE OF DECENCY?

McCarthy

JOURNAL OF BIOELECTRICITY, 3(12), 1–2 (1984)

EDITORIAL

The Environmental Protection Agency (EPA) was founded in 1970 “to protect and enhance our environment today and for future generations.” During the next decade, it earned a reputation as one of the more respected federal agencies. Its decisions were frequently litigated by industry and environmentalists, but they were generally well-reasoned, and occupied the middle ground. In 1980, Ann Gorsuch, became Administrator of the EPA, a choice widely criticized at the time as being based on political grounds. During the next several years there was an exodus of key professionals, and the EPA became a demoralized, do-nothing Agency. Following the Superfund scandal William Ruckleshaus was appointed to head the EPA. He was supposed to replace politics with science as the basis for EPA decisions, and set the Agency moving again. Under his leadership, however, things have not improved.

After examining the way the EPA responded to evidence of formaldehyde’s carcinogenicity, an MIT professor reported in Science (222, 894, 1983) that the Agency’s actions revealed “the interplay between politics and science policy in regulatory determinations. In some cases there were significant and unjustified departures from reasoned decision-making.” The Agency’s decision was, basically, to do nothing. Recently, an EPA official delivered essentially the same message to a national conference on toxics in ground-water: “We don’t have any quick fixes. This is going to be a long-term problem.” Much the same thing is occurring in the area of lead poisoning. A 1979 study published in the New England Journal of Medicine showed that children with high lead levels scored lower on IQ tests. The EPA then assembled what official of the National Institute for Occupational Safety and Health called a “hanging jury” (Science, 222, 907, 1983) which strongly attacked the study, thereby destroying the main argument for holding lead pollution to low levels—that is, the main argument for EPA to take action.

The situation has reached a new low with the recent efforts of the EPA in the matter of safety limits for environmental exposure to electromagnetic fields. In its Draft Study, the Agency’s staff arbitrarily adopted the approach that only thermal effects need he considered. But since there are no significant thermal-level exposures in the environment, the conclusion that is pregnant in the Draft is that there is no need for action to protect the public health. Ruckleshaus himself appointed a panel to review the Draft which consisted almost exclusively of individuals well known for their thermal-effects-only viewpoint: the majority view among scientists world-wide—that there exist biological effects due to non-thermal electromagnetic fields—was virtually unrepresented. It will not be surprising when this newest “hanging jury” largely endorses the staff’s approach. Worse still, is the avowed purpose of the EPA which is to issue so-called guidance to the 20 or so Federal Agencies that have a role in regulating the electromagnetic spectrum, and not to enact regulations pursuant to its broad congressional mandate. The EPA intends to palm off its responsibility to other federal agencies that have vastly less expertise and that are even more certain not to act.

The EPA was created by Congress to protect Americans from risks and threats against which the individual is almost completely defenseless. The public expects the EPA to be honest and fair, and to make decisions that protect the health of the American people. Instead, the EPA’s recent performance has been woefully reminiscent of what occurred at the McCarthy hearings 30 years ago when attorney Joe Welch, in complete revulsion of the Senator’s performance, said “You have done enough. Have you no sense of decency, sir?

At long last have you left no sense of decency?”

Andrew A. Marino

 

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