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Miguel San Sebastian
John P. Christopher, Ph.D., D.A.B.T.
29 September 2010
John P. Christopher, Ph.D., D.A.B.T. is a Principal Technologist with CH2M Hill, Inc., an engineering firm acting as Defendants' consultant. Dr. Christopher has over 30 years of experience in toxicology and assessment of the health risk due to exposures to chemicals in the environment. He received a B.S. in Biology from Georgetown University, an M.A. in Pharmacology from Stanford University, and a Ph.D. in Biological Science from Oregon State University. His professional experience includes five years conducting safety tests in animals for chemicals, drugs, and medical devices; four years as an environmental consultant and risk assessor, and 22 years as a Staff Toxicologist with the California Environmental Protection Agency. Dr. Christopher's work in California government included identifying safe doses of chemicals in air, soil, and groundwater; development of methods and regulatory guidance for human and ecological risk assessment of chemicals at hazardous waste sites; regulatory review of human health and ecological risk assessments submitted as part of the regulatory process for hazardous waste sites and permitted facilities; and de novo authorship of risk assessments for chemicals at hazardous waste sites. He is author or co-author of approximately 75 regulatory guidance documents, publications in peer-reviewed journals, and presentations at international scientific meetings. Dr. Christopher has performed regulatory review of hundreds of health risk assessments of contamination due to petroleum hydrocarbon waste at petroleum refming operations, military bases, and other sites in California.
For the past 15 years, Dr. Christopher has served as an invited peer reviewer and expert consultant regarding health effects of chemicals in the environment for the U. S. Environmental Protection Agency, the U.S. Department of Defense, the U.S. Department of Justice, Health Canada, Environment Canada, private companies, and non-governmental organizations. He served as an expert witness in toxicology and risk assessment as a government scientist with the California Environmental Protection Agency.
Dr. Christopher became certified as a Diplomate in General Toxicology by the American Board of Toxicology, Inc., in 1984; he was re-certified 1989, 1994, 1999,2004, and 2009; and he served as a member of the Board in 1999. Dr. Christopher became a member of the Society of Toxicology in 1984. He is a founding member and past-President of both the Risk Assessment Specialty Section and the Northern California Chapter of the Society of Toxicology; both organizations have honored him with service awards. In 2007, Dr. Christopher received a Lifetime Achievement Award from the International Conference on Soil, Sediment, and Groundwater for his career work as a government regulator in cleanup of hazardous waste. Certification by Author:
y knowledge and opinions on this matter.
Re: "Oil development and rural health in the Amazon basin of Ecuador: The popular epidemiology process"
Thesis submitted by to the University of London in fulfillment of the requirement for the degree of Doctor of Philosophy in the Faculty of Medicine, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine April 2001
Dr. Miguel San Sebastian divided his doctoral thesis into three sections. The first two describe purported relationships between the incidences of cancer and adverse pregnancy outcomes to petroleum hydrocarbons in drinking water in or near the Texaco concession in eastern Ecuador. The third presents a discussion of a method of study termed "popular epidemiology". Dr. San Sebastian's thesis is of crucial importance, because it forms the basis for several reports and publications of his and his colleagues that have been relied upon by the plaintiffs in the case of Maria Aguinda y Otros v. Chevron Corporation, and submitted to the court (San Sebastian and Cordoba, 1999; San Sebastian et al., 2001, 2002; San Sebastian and Hurtig, 2004, 2005). Further, in a recent submission by the Plaintiffs to the court, San Sebastian's data on cancer incidence has been exclusively relied upon by Daniel Rourke (201Oa, 201Ob) in reaching conclusions regarding excess cancers near the former Texaco concession.
In earlier comments, I noted that San Sebastian's published work contains serious scientific errors and clear evidence of bias (Christopher, 2010). Upon reading the doctoral thesis which underlies all these reports, I find that these flaws originated with San Sebastian's thesis research in the 1990's and continued throughout all the later work.
1. Overall Quality of the Work
As detailed in Christopher (2010), San Sebastian fails to meet established criteria for causal relationships between environmental conditions and the incidence of disease (Hill, 1965). In particular, San Sebastian claims to identify an association between the incidence of a cancer cluster with exposure to petroleum hydrocarbons in the environment. He concludes:
"In summary, there is evidence of severe contamination of water sources and apparent excess of cancer morbidity and mortality in the village of San Carlos. The excess of cancer could be linked, as local people suspect, to the pollution of the environment by toxic contaminants coming from the oil production." (p. 111)
In fact, San Sebastian failed to show either severe contamination or excess morbidity and mortality. Thus, his causal link seems to rely more on the suspicions of the subjects under study than on any valid scientific principle.
In his doctoral thesis and in the publications and reports which rely on it, San Sebastian demonstrates poor scholarship by doing the following:
• Providing inadequate documentation of exposure of the community to chemicals related to exploration for petroleum (e.g. detailed maps or quality control data on analytical chemistry);
• Providing no information on any dose-response relationship (e.g. increased incidence of disease with increasing exposure);
• Failing to demonstrate that his control population is representative of those he claims were exposed;
• Providing no plausible biological mechanism by which the supposed cancer cluster might have been caused by petroleum-related chemicals;
• Providing no information on confounding factors which could have interfered with his interpretation of his data (e.g. alcohol and tobacco use); and
• Examining no alternative hypothesis for how his observations could have come about (e.g. incidence of other diseases in this population).
When San Sebastian concludes that petroleum hydrocarbons are responsible for decrements in the health of his study population, he can only be relying on preconceived bias.
Recent submissions by Rourke (20lOa, 20lOb) contain an analysis of the numbers and costs of cancer deaths among the population studied by San Sebastian. Unfortunately, Rourke presents no qualifiers in his analyses to correct for the inaccuracies and errors in San Sebastian's work. In fact, Rourke accepts uncritically the entire body of the work in San Sebastian's doctoral thesis, which makes his analyses equally invalid.
2. "Popular Epidemiology"
The substitute for good scholarship in San Sebastian's work seems to have been reliance on "popular epidemiology". San Sebastian allowed bias to enter his work by ceding control of critical decisions to certain interest groups and the population being studied. San Sebastian expounds on his concept of multilateral participation ("power sharing") in the study of epidemiology. San Sebastian states the following:
"This thesis tells the story of how the relationship between local organisations and research institutions developed around an epidemiological study constructed to address communities' concerns. Local organisations set the agenda of the research: they were involved in the hypothesis formulation, consulted in each step during the study and responsible of the dissemination of the findings. This process is known as popular epidemiology." (p. 3)
"Some authors have argued that the research process might be strengthen [sic] by local, jointly negotiated, ethical codes or agreements that ensure the sharing of leadership, power and decision-making from design to dissemination." (p. 114)
"The main characteristics of the popular epidemiology process lie in the research being initiated because of local concerns and in the ownership of the process by a community or their organization." (p. 148)
It is absurd to assert that the subjects of an epidemiological study somehow retain ownership of the results of a scientific investigation into their health. Surely, obtaining valid results requires informed consent from the human subjects of study. This does not and must not carry any implication that the subjects of scientific study somehow accrue ownership of the study.
San Sebastian reveals why he believes he has less need for proving causal relationships than classical epidemiologists:
"Faced with a diversity of disease and risk factors, [epidemiologists] adopted an essentially empirical approach, establishing and testing hypothesis through carefully designed research methods. Numeric reasoning, based on statistical modelling [sic], was central to the effort. This approach has had some remarkable success in discovering the pattern and aetiology of disease, but it is less well equipped for understanding the complexities of many aspects of health (Baum, 1998). The growing realisation that health and illness reflect the structure, culture, power relationships, economy and politics of a society has resulted in public health seeking to understand more about health and disease than the immediate cause of any particular disease .... Health and ill health are consequences of how society is organized and behaves, social and economic forces have impacts on disease incidence rates, and community actions will be effective in altering incidence rates." (p. 140).
San Sebastian is stating here that the causes of disease can be studied only inadequately with the science of epidemiology. If he believes this, then he cannot ascribe the incidence of cancer and adverse birth outcomes to petroleum exploration without attempting to control his studies for the social, economic, and political factors which he says form such great influences on "health". Attempting to control these variables becomes a political exercise, not a demonstration of the scientific method.
3. Involvement of the Amazon Defense Front
San Sebastian goes into detail in his doctoral thesis regarding his relationship with the Amazon Defense Front, referred by its Spanish acronym FDA. He states that the raison d'etre of this organization is to generate evidence to be used in legal proceedings against companies which developed petroleum resources in the upper Amazon basin, but he states further that FDA was also an active participant at every step in his research:
"FDA was created with the aim of supervising the trial against Texaco oil company .... Later, FDA got involved in meetings, workshops and campaigns that strengthened the movement. The way forward in the research process was decided upon the interaction between the knowledge and concerns the FDA had over health impacts of oil contamination and the academic knowledge provided by the epidemiologist." (p. 119).
It is especially disturbing that San Sebastian accepted the advice of the Amazon Defense Front to leave their name off his "Yana Curi Report" (1999), which was later published as San Sebastian et al. (2001). The Amazon Defense Front could not have left their name on this study and still
have claimed that this was independent work on the health of the residents of the oil concession in eastern Ecuador.
"After discussions between FDA and the epidemiologist, it was decided that the name of FDA would appear neither on the cancer cluster report nor on the "Yana Curi" report [San Sebastian and Cordoba, 1999]. This decision was based on the thinking that the report would carry more weight and reach a broader audience if it was presented as an independent report" (p. 125)
After going to great lengths to explain the importance of multiple levels of participation in "popular epidemiology", San Sebastian betrays the fact that the Amazon Defense Front could not be associated with his work without introducing the appearance of bias. If this were true at the time of dissemination of the results, it had to have been true at all earlier steps of the process. His willingness to conceal the involvement of the Amazon Defense Front, in order to present the report as if it were an independent scientific study, demonstrates a disturbing lack of candor. To me, it seems most likely that the Amazon Defense Front was seeking to conceal their involvement in San Sebastian's work so the work could be introduced as independent evidence in any future legal proceeding.
San Sebastian's doctoral thesis forms the underlying basis for numerous reports and publications relied upon or submitted to the court on the subjects of cancer incidence, adverse birth outcomes, and "popular epidemiology".
San Sebastian's thesis work demonstrates poor scholarship and obvious evidence of bias. San Sebastian failed to demonstrate a causal link between disease and petroleum exploration and production.
All other reports based on this thesis work suffer from the same fatal flaws, including recent submissions by Rourke (20 lOa, 20 l Ob), purporting to calculate excess incidence of cancer and attendant costs of disease.
San Sebastian allowed the Amazon Defense Front, an organization primarily concerned with seeking legal compensation for claimed damages, to exert excessive control over the design, conduct, and dissemination of his work.
All these factors call into question the objectivity and scientific validity of San Sebastian's work.
Christopher, J. P. (2010), "Evaluation of the Scientific Value of the Published Work of Plaintiffs' Experts, Dr. Miguel San Sebastian and Colleagues", 6 September 2010.
Rourke, D. (2010a), "Estimate of the number and costs of excess cancer deaths associated with residence in the oil-producing areas of the Sucumbios and Orellana Provinces of Ecuador", 12 September 2010, submitted to the court in the case of Aguinda v, Chevron.
Rourke, D. (2010b), "Addendum: Estimate of the number and costs of excess cancer deaths associated with residence in the oil-producing areas of the Sucumbios and Orellana Provinces of Ecuador", 15 September 2010, submitted to the court in the case of Aguinda v, Chevron.
San Sebastian, M., and Cordoba, J. A. (1999), "Yana Curi Report, The impact of oil development on the health of the people of the Ecuadorian Amazon", Departamento de Pastoral Social del Vicariate de Aguarico, London School of Hygiene and Tropical Medicine, Medicus Mundi, June 1999.
San Sebastian, M., Armstrong, B., Cordoba, J. A., and Stephens, C. (2001), "Exposures and cancer incidence near oil fields in the Amazon basin of Ecuador", Occupational and Environmental Medicine;S8:517-522.
San Sebastian, M., Armstrong, B., and Stephens, C. (2002), "Outcomes of pregnancy among women living in the proximity of oil fields in the Amazon Basin of Ecuador", International Journal of Occupational and Environmental Health, 8:312-319.
San Sebastian, M., and Hurtig, A. K. (2004), "Oil exploitation in the Amazon basin of Ecuador: A public health emergency", Pan American Journal of Public Health, IS(3):205-211.
San Sebastian, M., and Hurtig, A. K. (200S), "Oil development and health in the Amazon basin of Ecuador: The popular epidemiology process", Social Science & Medicine, 60:799-807.
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