[Ibid., page 25 -26, paragraph 20] [The Honorable Judge (as he was described at the time) 10. Amit].
Discussion and conclusions
- I did not find it possible to adopt Shlita's professional opinion and his conclusions.
- It is interesting to mention that Shlita, in his first opinion, attributes the air pollution to the Kishon water (and not to the emission from the chimneys of the respondents directly), according to him.that many pollutants reached the air from the Kishon water, which was continually polluted" (see section 119 above).
- The main thesis-theory of the 'free radicals' advocated by the expert, which has not been given a solid scientific basis, was rejected head-on in the Kishon case and in the appeal to the Supreme Court as cited above, and in the absence of a substantive and scientific reason to deviate from this ruling, there is no prima facie basis for adopting this 'copied' thesis within the framework of the present application (see Exhibit M/1).
- Shlita testified about the free radicals that "...Some are short-lived and some are long-lived", he was asked if anyone had measured "...The concentration of free radicals in a person exposed to air pollution versus the concentration of free radicals in a person who has not been exposed to air pollution," and he replied that yes, "...But it doesn't appear in my opinion."
Dr. Shlita confirmed in his interrogation of free radicals that the greater the concentration of radicals, "the greater the risk" since it is all a matter of "measure." He was shown that "... In some concentrations, an excess of radicals will form and there will be a risk of cancer, in other concentrations there will be no excess of radicals and there will be no risk of cancer. Right?", and he replied, "There is such a chance" (p. 175). The expert's opinion did not provide data on concentrations or exposure times, which would lead to the formation of cancer-causing free radicals.
- Shlita was asked in his interrogation whether he found in his opinion "what radicals cause cancer" and he replied "...More or less," he was asked if he knew how to say, "What radicals cause cancer?and replied that it appears in Cook's article, he was asked, "Where else in your opinion will I find the distinction between radicals that cause cancer and radicals that do not?" and replied: "I am not sure I referred to it" (page 96, lines 1-31).
- Shlita was asked whether he had a way of diagnosing "...Is a radical found in the body caused by bread or running or schnitzel?", his answer: "...No one will know how to diagnose it." In light of his answer above, he was shown that if we do not know how to diagnose what caused the radicals in the body, then "... No one knew how to diagnose whether they were caused as a result, let's say by engaging in sports or schnitzel, or as a result of exposure to pollutants in the air," his answer: "... Maybe not, not sure... I don't know how to say" (page 176, lines 18-23).
- Shlita was asked, among other things, whether his opinion contains "... A description of another mechanism that causes cancer that is not radical," and he replied that there should be a but, "... I don't remember if I wrote them" (page 146, lines 20-22).
- The expert's testimony did not even make a reliable and convincing impression, and this relates to, inter alia, the (significant) copying of the EquiWiki website, the 'omission' of what was stated in it that did not support his version, the inaccuracies and errors that occurred in the opinion [as detailed above], and the lack of a scientific and up-to-date basis for the theory he tried to persuade, including from the same sources to which he referred.
- The expert's opinion, as well as his testimony in court, did not support the Applicants' claim of excess morbidity or the existence of a causal link. Contrary to what is claimed by the applicants, I have not found that Dr. Shlita was able to assist in the scientific-reliable manner required within the scope of this application for approval, in determining even prima facie that they had proven "a definite causal link between exposure to substances [emitted from the respondents' factories] and cancerous diseases".
Prof. Shai Lin - Epidemiologist, Public Health Expert
- In the main opinion and the supplementary opinion (Appendices 14 and 14.1 respectively), Prof. Lin – another expert on behalf of the Applicants – discussed the issue of the causal connection between air pollution and morbidity of residents in Haifa Bay. Lin notes that he is based on two assumptions. The first is that there is an excess of cancer morbidity in Haifa Bay; The second is that the population in Haifa Bay is exposed to air pollution from various sources, including certain and possible carcinogens and other substances that harm health. The purpose of the opinion is to point out the causal connection between the two.
- According to Lin's method, which is based on the principle of "minimal satisfactory cause", cancer is caused not by a single cause, but by a combination of several risk factors for cancer (such as genetic predisposition, smoking, alcohol, age, environmental pollution, etc.), which work together or separately, and prepare the person for the fact that when the person is exposed to other risk factors, there is already a "sufficient reason" for the appearance of cancer in that person.
- Only the effect of all the risk factors together creates a situation in which the intervention of the additional risk factor creates a sufficient reason for the outbreak of the disease. Hence, each of the factors is a necessary causal factor that contributes to the onset of the disease. The absence of any of the causal factors will prevent the completion of the causal process and therefore prevent the disease.
- The determination of a causal relationship between exposure to a risk factor for cancer and the onset of cancer in an individual is qualitative rather than statistical, and the causal relationship is retrospective (forward-looking) rather than prospective (forward-looking). In other words, if it is discovered that a person has cancer, then in retrospect, it is now determined that there is a causal connection between the risk factor and the disease.
- Therefore, if there is air pollution to which the residents of Haifa Bay were exposed, then there is a high probability that the pollutants acted separately and all together, together with the other risk factors to which the residents were exposed, in order to create a sufficient cause of cancer. It should be emphasized that this refers only to contaminants that have been recognized as certain or possible carcinogens by the international medical institutions and the Ministry of Health in Israel.
- According to him, once a substance has been recognized by the relevant medical bodies as a possible or certain carcinogen, there is no longer a need to prove causation between exposure to the substance and cancer morbidity.
- The principle of "minimal sufficient cause" is based on Prof. Rothman's "causal cookies" theory, which is summarized – a disease occurs when a "set of causes" work together to create a sufficient cause for the disease, in the presence of which the disease is inevitable. Different factors act in different circumstances and in different combinations in each person.
- If so, air pollution can be a cause of cancer, whether as one of the risk factors that were catalytic factors that prepared a person for exposure to one additional risk factor to be "the straw that broke the camel's back", or as the same other risk factor that "broke the camel's back". Either way, there is a qualitative causal relationship between air pollution and cancer.
- Lin notes that his theory is true both for cancer and for heart disease, lung disease, and other diseases, if there was exposure to substances known to be risk factors for these diseases.
- In his supplementary opinion, Lin referred to the opinion of Prof. Rennert (which was brought on behalf of the respondents). Prof. Rennert criticized Prof. Grotto, but did so by rejecting three of the 61 articles presented by Prof. Grotto. According to him, this selective choice is puzzling and unacceptable.
- Contrary to Prof. Rennert's opinion, epidemiological research not only proves a link between risk factors for the disease, but also proves causation. In this way, in fact, it is determined which substances are most likely causative causes of cancer and which are certain carcinogens. Exposure to a carcinogen is certainly causally associated with a high probability of a high risk of morbidity after exposure, even if there is exposure to other risk factors. Injury from one factor leads to a greater likelihood of susceptibility to injury from another factor.
- The question of which substances are carcinogenic and which should not be based on the determinations of experts from the relevant international bodies and not on an independent analysis of findings with a 95% confidence level or when the P value is a positive error of determining a causal link, less than 5%. Lin emphasizes that while the IARC documents indicate which types of cancer it causes in relation to each substance, once it has been proven that a certain substance is carcinogenic, it is no longer attributed to a specific organ but to the person to whom it has been exposed. The list of certain or suspected carcinogenic substances refers to carcinogens to a person, not to a specific organ.
- The decisions of these bodies are based, among other things, on published articles, but also on other scientific considerations that indicate the validity of the studies and the absence of biases in the studies. The decisions also include consideration of Hill's guidelines for proving causation. Moreover, these are non-binding guidelines, and they are also intended to discover a new causal connection and not to confirm a causal connection that is already known. In addition, these guidelines have been developed in relation to acute diseases, such as infections, and are not always suitable for chronic diseases such as cancer.
- Rennert's approach that there is no danger of ionizing radiation in Haifa Bay, and on the contrary, that even low-dose radiation is beneficial to health, is unreasonable and unacceptable. Past studies have already determined that there is no safe threshold for exposure to carcinogens or mixtures of carcinogens.
- Rothman's cookie model is not only theoretical and is not based on mere hypotheses, as Rennert claims, but is well known and accepted in epidemiology. According to Rotman, indeed, in a certain combination of circumstances, any factor, no matter how negligible and distant, is liable to be "the straw that broke the camel's back."
- Exposure to certain carcinogens leads to biological and medical damage in at least five ways: causing cancer by damaging DNA; re-damage to DNA damaged by other factors; loss of opportunity for health; loss of opportunity to recover from the disease; loss of opportunity for milder or more responsive disease to
- Exposure to carcinogens certainly causes damage to vulnerable populations, because the mere knowledge of the risks leads to fear, anxiety, a decrease in the value of assets, and the loss of job opportunities.
- Lin reiterated the claims that high morbidity rates in Haifa Bay relative to the rest of the country have been proven, and that the causal link between pollution and morbidity has been proven. To this end, Prof. Lin refers to the second Grotto report and various publications in the press and on the Internet.
- Against Prof. Lin's position, the respondents submitted three opinions – the first by Gad Rennert, an epidemiologist, the second by Dr. Julie Goodman, and the third (in fact primary and supplementary) also by Dr. Julie Goodman dated December 14, 2023, which was submitted in lieu of the opinion of Dr. Joseph Rodriguez (see above).
The Respondents' Expert Criticism of Prof. Lin's Opinion in Summary
- According to Rennert, two studies – the first at the University of Oxford and the second at the Harvard Cancer Prevention Center – estimated the weight of all exposures to carcinogens to the risk of cancer morbidity. Smoking, diet, and lack of physical activity were found to be responsible for 60-70%. Genetics, hormones, exposure to biological pathogens (e.g., viruses), occupational exposures, exposure to medical treatments, and radiation from multiple sources were found to be responsible for an additional 25-30%. Air, water and soil pollution (all together) were found to be responsible for only 3-4%. No specific estimate of air pollution from industrial sources has been given. Therefore, the attempt to link a high rate of cancer morbidity to environmental exposure seems to have a very low chance.
- According to him, Prof. Lin's claim that if a person is exposed to a carcinogen and there is cancer, then the carcinogen caused cancer is devoid of any scientific and logical basis, and does not represent the scientific and logical method for investigating the relationship between exposure and disease. In order to determine that such a relationship exists scientifically or medically causally, epidemiological research must be conducted or relied on the results of epidemiological studies published in medical journals with a high quality score.
- All epidemiological research methods are used to demonstrate an association between a cause and a disease, not to determine The scientific literature states that such a relationship warrants reporting and reference only when demonstrated with a statistical value of P less than 5%, meaning that there is a 95% certainty that the association in the specific study does exist.
- In order to determine causation through epidemiological studies, the results of many studies must be taken into account and examined according to accepted rules or criteria, also known as the Hill These criteria do not need to be fulfilled in all or in full, and there are more important and less important among them, and yet the more they are fulfilled and the higher the intensity, the greater the probability that the relationship being examined is not accidental and is indeed causal increases. And these are in essence of the Hill criteria: consistency; the intensity of the risk; Serving-response ratio; biological logic; Specificity; Exposure sequence - disease.
- A simplistic approach that states that the presence of any cancer automatically requires that if there is a case of cancer in its environment, then the causal connection between them exists is not at all scientifically acceptable. This approach also assumes what is sought and requires proof and ignores the circumstances of the exposure, the form of exposure, the concentration of the active ingredient, the type of disease being examined, and the specific risk factors and personal data of each and every patient. Western people have lived their entire lives for a reason that is exposed to known carcinogens - such as solar radiation, secondhand smoke, hormones, transportation, and more. Even with regard to certain carcinogens to which exposure is proven, certain and high, such as the sun (skin cancer), cigarette smoking (lung cancer) and drinking alcohol, the rate of malignant diseases they cause is tiny compared to the size of the population exposed.
- Rennert emphasizes that cancer is not a single disease, but rather an umbrella name for many diseases that are completely different from each other, each with a different biology and different factors, and the common denominator of all diseases is the process of uncontrolled division of cells. Therefore, from a medical-biological point of view, the claim that air pollution or any other risk factor caused an increase in all cancers is meaningless, but rather specific diseases must be addressed individually.
- The cookie theory on which Prof. Lin relies remained in the theoretical field because it did not stand the test of reality. This is a theory that has no biological logic, and beyond that, it has no practical meaning, because every person is exposed to hundreds and thousands of substances every day, and every person has unique genetics. Accepting Prof. Lin's interpretation of the 'cookie theory' omits any attempt to establish significant exposure and morbidity associations that can be taken to reduce exposure and prevent the disease.
- According to Goodman, Prof. Lin is also wrong in his understanding of Prof. Rothman's cookie theory. Cookie theory is designed to analyze causation scenarios for disease and the causes or factors that contribute to it, and is not intended to provide information about the evidence for end-to-end risk factors or what level of exposure is necessary to cause disease. It should be emphasized that the definitions of substances as possible or certain carcinogens (by the IARC) relate only to the identification of risks, as opposed to risk assessment, in which the characterization of exposure-response will then be used to assess cancer risk for a particular scenario and the intensity of a particular exposure.
- If Prof. Lin's interpretation was correct, then every person who breathed would inevitably develop cancer. On the contrary, if air pollution were to contribute to lung cancer, morbidity would be higher in more developed areas, while studies prove the opposite.
- Lin's theory not only contradicts scientific evidence regarding cancer rates and their relationship to air pollution, but also ignores one of the most fundamental concepts in toxicology, according to which "only the dose does the poison" (in Latin: sola dosis facit venenum). For a component to cause a harmful event, there must be sufficient exposure of the person or tissue to that component.
- Lin's claim of lack of threshold is wrong, and can be contradicted by the example of radiation. Low doses of sun exposure, which is a source of radiation, can cause the skin to produce vitamin D, and specific doses of radiation are even used to shrink cancerous tumors. In these cases, exposure to radiation that is carcinogenic is certain, in certain doses, actually helps health.
- In order to determine whether there is a synergistic effect between the components of a chemical mixture, it is necessary to evaluate the behavior of each and every ingredient, its movement throughout the body, and its toxicity in specific tissues in the body. In the absence of such information, the instructions of the US authorities are to treat each of the components individually, and to attribute to them a correlated interaction (neither synergistic nor antagonistic, but simply the sum of the components). Lin did not specify any components or concentrations that were present in the air of Haifa Bay, so he cannot predict the nature of the interaction between the components.
- The bottom line is that Prof. Lin's opinion is based on a misunderstanding of causation and not on accepted scientific methods, and therefore cannot be used to assess causation. His analysis is purely qualitative, and does not take into account specific exposures and risks for Haifa.
- In Dr. Goodman's opinion of December 14, 2023 (replacing Rodrix's opinion), she emphasizes that an increased health risk to a particular individual requires the establishment of both general and specific causation. General causation requires proof that the specific health problem can be specifically caused by the chemical in question, a proof based on Hill's criteria. Specific causation requires proving that the exposure of any individual to the chemical in question was strong and for a sufficient time to cause an effect. Specific causation also requires control for potential intervening variables.
- According to her, Prof. Lin made no attempt to determine a general causation for specific contaminants or specific health effects. He also failed to link specific individual exposures to their health effects, nor did he attempt to differentiate between pollutant emissions from different sources.
- When Prof. Lin determines the existence of a causal link between exposure to the chemical and cancer, he ignores the importance of dosage in determining specific causation and also ignores the possibility that the cancer was caused by other or unknown causes.
- Lin's theory of non-threshold is not considered accepted by the scientific community, and since it is only an unproven theory, it is not considered valid proof of the causation of diseases even among its proponents. Indeed, regulators rely on this theory as the basis for preventive exposure safety standards for such chemicals, but this is influenced by culture, politics, and the perception of social risk, rather than scientific findings. Finally, this theory is unique and exclusive to carcinogenic processes and there is no proof or hypothesis that such a mechanism also applies to non-cancerous effects.
- Lin incorrectly characterizes Prof. Rothman's cookie theory. It ignores the importance of dosage and level of exposure. A high level of exposure can indeed be a constituent factor of disease, but no evidence has been presented that even a much lower dose can be a constituent factor. Regarding the claim of synergism, the instructions of the US authorities are to relate to each component separately and to attribute to them a connective and non-synergistic interaction.
Testimony of Prof. Shai Lin
- At the beginning of his testimony, Prof. Lin was asked about the sources in his opinion on which he relied, and he replied as follows:
Q: In the opinion here you referred to the sources