NEW SOLUTIONS, Vol. 24(3) 259-266, 2014
Comment and Controversy CONFLICT OF INTEREST, TAILORED SCIENCE, AND RESPONSIBILITY OF SCIENTIFIC INSTITUTIONS AND JOURNALS KATHLEEN RUFF DARIO MIRABELLI
ABSTRACT
Recent revelations have raised concerns on how conflicts of interest may involve even leading scientists and prestigious institutions and lead to bias in reporting and assessing scientific evidence. These have highlighted the need for action to safeguard scientific integrity and public health. The Italian Epidemiology Association has declared that the “biased and deliberately tailored use of the scientific evidence” by scientists with a conflict of interest serves to delay needed measures to prevent harm to public health from a polluting Italian steel plant’s continuing chemical emissions. In France, unresolved concerns over conflict of interest forced the Centre for Research in Epidemiology and Public Health to cancel its imminent appointment of a prominent scientist as its Director. These negative events demonstrate the necessity for scientific institutions and journals to implement rigorous measures regarding conflict of interest and the safeguarding of scientific integrity and public health.
Keywords: worker health and safety, environmental health, science policy, public health history
The ILVA steel plant in Taranto, in southern Italy, is the largest steel plant in Europe and has for years spewed out dioxins, benzo[a]pyrene, and other cancer-causing chemicals from its smokestacks, polluting the land, water, and 259 Ó 2014, Baywood Publishing Co., Inc. doi: http://dx.doi.org/10.2190/NS.EOV http://baywood.com
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neighbourhood around it. The head of the company, Emilio Riva, was twice convicted of environmental offences, but no effective enforcement action was taken by government regulatory agencies to require ILVA to comply with environmental regulations. An Italian court described ILVA as an “environmental disaster.” High levels of air pollution and an excess in lung cancer mortality of approximately 30 percent in the population of Taranto were documented in reports by Italian environmental and health authorities—including the National Health Institute, the regional health authorities, and the scientists appointed by the Taranto court to assess the health consequences for the population and provide a report [1-4]. The court therefore ordered that the plant be put under special administration until the company took action to clean up the contaminated area and to implement pollution controls. Giorgio Assennato, head of the environmental authority for the Puglia region (ARPA), stated to media that the fact that it took the courts to intervene and shut the plant, despite repeated warnings from ARPA and other authorities, laid bare a dangerous weakness in regulatory control. “We have to accept the fact that in Italy you have to turn to the criminal justice system because the system of environmental governance is unbalanced by lobbies, which use improper practices to influence institutions for their own advantage,” said Assennato [5]. Health scientists in Italy have been calling for action to address this continuing environmental and public health catastrophe. Carlo La Vecchia and Paolo Boffetta were hired as consultants by the Riva group, the company that owns ILVA, to assist it in the court case against ILVA. They submitted to the Special Administrator of ILVA a 44-page report, which disputed the findings of the scientists from the National Health Institute, the regional environmental authority, and the court-appointed scientists. In addition, La Vecchia and Boffetta disputed the authority of the regional government’s environmental regulations. La Vecchia and Boffetta’s report exonerated the ILVA steel plant, saying its emissions had not contributed to the excess cancer and respiratory diseases amongst the population of Taranto [6, 7]. CONFLICT OF INTEREST In July 2013, the Italian Epidemiological Association (IEA) issued a press release [8], which described the report by La Vecchia and Boffetta as scientifically flawed and biased—and also noted their conflict of interest, which they had not disclosed in their report. The IEA stated, “The document, signed by consultants for the Riva company disputes the data on the health impact of pollutant emissions and argues that the increased incidence of cancer and chronic respiratory and cardiovascular diseases in Taranto should not be attributed to environmental pollution produced by ILVA but to lifestyle; in particular, the increase in lung cancer should be attributed to cigarette smoking.”
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The IEA expressed strong concern over “the biased and deliberately tailored, pseudo-scientific use of data in order to invalidate the evidence produced to date from epidemiological studies and to disregard the health impact of ILVA emissions on the population and workers.” The IEA media release included the following points. Based on the numerous studies conducted to date in Taranto, the Italian Association of Epidemiology states that: • The environmental data showed that the Taranto population was exposed for decades to high levels of different chemicals with known carcinogenic properties, that are well documented in the scientific literature; • Multicenter epidemiological studies and epidemiological studies of the health impact on populations living in the area have documented that air pollution has led to an increase in mortality and morbidity from heart and respiratory diseases; • The study carried out by the (Italian) National Institute of Health showed an excess mortality for lung cancer in the population of Taranto of approximately 30 percent in both genders (Pirastu et al., 2011); • The most recent epidemiological studies have documented short and long term health effects (mortality from heart diseases and acute coronary events, and a significant increase in mortality from respiratory diseases and cancers in the population 0-14 years); these effects were stronger in most polluted neighborhoods (Tamburi and Borgo) compared to the entire town of Taranto (Mataloni et al., 2012). The IEA stated that “it is a matter of concern that in our country a position can be argued, that is clearly opposed to the evidence produced by international studies and accepted by the World Health Organization. This is a pseudo-scientific position, based on the opinion of individual researchers who are in a position of clear conflict of interest (expert witnesses for ILVA).” The IEA highlighted the urgent need to take action to protect public health: “Finally, the Italian Epidemiological Association considers that the data that has already been produced is sufficient to treat as an urgent matter that cannot be delayed the implementation of measures for abatement of air pollution levels in the area of Taranto, and remediation of contaminated sites, to safeguard the health of the resident population and that of future generations.” RESPONSIBILITY OF SCIENTIFIC INSTITUTIONS AND JOURNALS It is disturbing when scientists, who hold prestigious positions as directors of academic institutions and editors of scientific journals, work as consultants for industries and then write documents that, to advance the financial interests of the industry, misrepresent the scientific evidence and undermine public health
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protection. The prestigious positions they hold in academic organizations and scientific journals lend credibility to the distorted scientific arguments they put forward as industry consultants. Furthermore, such activities conflict with the mission of the institutions and journals they represent, which tell the public that their mission is to safeguard scientific integrity and advance public health protection. Professor Boffetta holds the position of Director of the Institute for Translational Epidemiology and Associate Director for Population Sciences of The Tisch Cancer Institute at Mount Sinai School of Medicine in New York. He is associate editor of Lung Cancer, European Journal of Clinical Investigation, and Frontiers in Cancer Epidemiology, and is a member of more than 10 editorial boards of scientific journals. He is the founding member of several international cancer epidemiology consortia and networks [9]. Professor La Vecchia is an Editor of the European Journal of Cancer Prevention and other journals and is a member of the International Advisory Board of the European Cancer Prevention Organisation. At the time of writing the ILVA document, he was Head of the Department of Epidemiology at Mario Negri Institute. He is also a professor in the Department of Occupational Health of the University of Milan. Boffetta and La Vecchia have, together or separately, written articles denying harm caused by substances that have been recognized by reputable scientific agencies as being carcinogenic or otherwise harmful, such as dioxins, beryllium, formaldehyde, styrene, diesel fumes, silica, and continued exposure to asbestos [10-16]. They have also stated in a number of articles, which denied the carcinogenic effect of substances such as formaldehyde, acrylamide, silica, and continued asbestos exposures, that the Italian Association for Research on Cancer (AIRC) had funded the articles [14-18]. These statements of financial support by AIRC lent the credibility of this cancer association to the articles, but AIRC had provided no funding [19]. Should not scientific institutions and journals, which claim to pursue scientific integrity and public health protection and are accordingly entrusted with public funds, require that scientists they place in leadership positions comply with their stated mission [20-24]? Universities and scientific journals generally recognize a responsibility to guard against scientific work financed or influenced by the tobacco industry, yet some seem to turn a blind eye to distortion of the scientific literature by other industries. A recent editorial on conflict of interest published by the journal Nature [25] makes the critical point that the power balance between industries producing toxic products and those harmed by such products is extremely asymmetric. Workers and their families and impoverished neighbourhoods around the world, who, in particular, are exposed to harm from toxic products, have little economic, social, or political power to stop such injustices or to challenge the corruption of science. Furthermore, while industries pay tens of millions of dollars to hire scientists to protect their financial interests [26, 27], there is
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diminishing public funding for scientists working to defend public health. It would be a better system if, when industries wish to fund research into health effects of toxic substances, they were required to provide the funds to reputable public agencies so as to enable the research to be carried out in an independent manner, free of conflict of interest. Currently, however, independent science that serves the public interest, rather than private profit, is under threat. In light of this imbalance, scientific institutions and journals need to put in place policies to address and stop such abuse. Clearly, they should adopt strict requirements for disclosure of conflicting interests. In addition, warning bells should ring and, at the very least, an independent review should be required, when a scientist, particularly one entrusted with a leadership position, is: 1. working as an industry consultant or working with a consulting company that specializes in carrying out industry-financed studies that deny harm caused by the industries’ products and activities; 2. putting forward scientific work that serves the industry’s interests; 3. showing indifference to or rejection of the precautionary principle; and 4. preventing or impeding occupational and environmental health protections that independent scientists and reputable scientific agencies are calling for. The review should examine whether the scientist’s work conflicts with the stated mission of the institute to uphold the integrity of science and the protection of health. A requirement for holding a leadership position with the institute should be that the scientist does not work against its mission, but instead advances its mission and is an exemplary role model for the upcoming generation of scientists. The National Institute for Health & Medical Research (INSERM) and the University of Paris-Sud (UP-S) in France have recently been forced to address this issue. INSERM and UP-S are responsible for the Centre for Research in Epidemiology and Public Health (CESP), which is France’s coordination centre for public research in epidemiology. They had responsibility for appointing a new Director of CESP, who would assume the position at the end of 2014. Paolo Boffetta was the sole candidate under consideration and about to be appointed as the new Director. The policy in place requires that the Director of CESP should be solely involved in work to advance public health and should have no conflicting interests, such as receiving funds or having contracts with private sources. Boffetta’s candidacy had been criticized by a number of scientists and by the French National Association of Asbestos Victims because of his close ties with industry over recent years and because he had co-authored a series of industry-funded articles, all of which denied harm from the industries’ products, in spite of the fact that these products had been recognized to be carcinogenic by the International Agency for Research on Cancer. Boffetta withdrew from his relationship with a private consulting company (International Prevention Research Services), which carries out research projects
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commissioned by industries. He continued, however, to pursue private consulting, such as for the pharmaceutical company, Takeda, acting as a consultant in an upcoming U.S. court case regarding its anti-diabetic drug, Actos. This drug was withdrawn from the market in France in 2011, following a government study which indicated a risk of bladder cancer [28]. In light of his continuing financial ties to industry, doubts started to be raised at CESP that Boffetta would be an acceptable director. Boffetta withdrew his candidacy. This is an unfortunate and sad example of what may happen if a clear policy of conflict of interest avoidance is not rigorously followed from the very beginning in institutions dedicated to public health protection. It is time to stop turning a blind eye to the issue of conflicting interests. It is time to require that public health, scientific, and academic institutions demonstrate by their actions a genuine commitment to their stated mission to uphold the integrity of science and the protection of health. Editor’s Note: New Solutions requires that contributing authors disclose any competing interests, financial or non-financial (that is, for example, political, personal, commercial, or any other in relation to their manuscripts), and, if uncertain, to “discuss it with the editors.” AUTHORS’ BIOGRAPHIES KATHLEEN RUFF has worked extensively in the field of human rights. She was director of the British Columbia Human Rights Commission and is a founding coordinator of the Rotterdam Convention Alliance. She has published articles in journals, civil society publications and the media on health issues and ethics. She can be contacted at [email protected]. DARIO MIRABELLI is an occupational health physician. He works in the Unit of Cancer Epidemiology, University of Turin (Italy) and Turin teaching hospital, where he is in charge of the regional Registry of Malignant Mesotheliomas. He was expert witness for the public prosecutor in criminal trials where liability of factory managers for asbestos-related deaths among workers was challenged. He can be contacted at: [email protected]. NOTES 1. R. Pirastu et al., “Studio epidemiologico nazionale dei territori e degli insediamenti esposti a rischio da inquinamento: risultati” [Mortality results in SENTIERI Project], Epidemiologia e Prevenzione 35(Suppl 4) (2011): 29-152, http://www.epiprev.it/sites/ default/files/EP2011Sentieri2_lr_bis.pdf (accessed March 31, 2014). 2. P. Comba, S. Conti, I. Iavarone, G. Marsili, L. Musmeci, and R. Pirastu, “Ambiente e salute a Taranto: evidenze disponibili e indicazioni di sanità pubblica” [Environment and health in Taranto: Available Evidence and Public Health Perspectives], http:// www.salute.gov.it/imgs/C_17_pubblicazioni_1833_allegato.pdf (accessed March 28, 2014).
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3. ARPA Puglia, Valutazione del Danno Sanitario Stabilimento ILVA di Taranto ai sensi della LR 21/2012—Scenari emissivi pre-AIA (anno 2010) e post-AIA (anno 2016) [Health Effects Assessment for the ILVA Plant in Taranto According to Regional Law 21/2012: Before (2010) and After (2016) Integrated Environmental Authorization Emission Scenarios], http://www.arpa.puglia.it/web/guest/vds (accessed March 28, 2014). 4. F. Mataloni et al., “Studio di coorte sulla mortalità e morbosità nell’area di Taranto” [A cohort study on mortality and morbidity in the area of Taranto, Southern Italy], Epidemiologia e Prevenzione 36 (2012):237-252. 5. James Mackenzie, “Steel Pollution Case Highlights Italy’s Slow Decline,” Reuters, August 29, 2012, http://www.reuters.com/article/2012/08/29/us-italy-pollution-idUSBRE87S07B20120829 (accessed March 28, 2014). 6. C. La Vecchia and P. Boffetta, “Lo Studio SENTIERI—Elementi di critica” [Critical appraisal of SENTIERI], June 19, 2013, annex 3 to Boffetta et al. [7]. 7. P. Boffetta, C. La Vecchia, M. Lotti, and A. Moretto, Commenti al documento ‘Valutazione del Danno Sanitario Stabilimento ILVA di Taranto ai sensi della LR 21/2012—Scenari emissivi pre-AIA (anno 2010) e post-AIA (anno 2016)’ dell’ARPA Puglia, [Comments on the Document ‘Health Effects Assessment for the ILVA Plant in Taranto According to Regional Law 21/2012: Before (2010) and After (2016) Integrated Environmental Authorization Emission Scenarios], 27 June 2013, http:// www.arpa.puglia.it/web/guest/vds (accessed March 28, 2014). 8. Associazione Italiana di Epidemiologia, “Comunicato stampa dell’AIE sull’ILVA di Taranto” [Press release on ILVA, Taranto], 15 July 2013, http://www.epiprev.it/ comunicato-stampa-dellaie-sullilva-di-taranto (accessed March 28, 2014). 9. Mount Sinai Hospital, “Paolo Boffetta / Biography,” https://www.mountsinai.org/ profiles/paolo-null-boffetta (accessed March 31, 2014). 10. P. Boffetta et al., “TCDD and Cancer: A Critical Review of Epidemiologic Studies” Critical Reviews in Toxicology 41 (2011): 622–636, doi: 10.3109/10408444.2011. 560141. 11. P. Boffetta, J. P. Fryzek, and J. S. Mandel “Occupational Exposure to Beryllium and Cancer Risk: A Review of the Epidemiologic Evidence,” Critical Reviews in Toxicology 42 (2012): 107–118, doi: 10.3109/10408444.2011.631898. 12. P. Boffetta et al., “Epidemiologic Studies of Styrene and Cancer: a Review of the Literature,” Journal of Occupational and Environmental Medicine 51 (2009): 1275–1287, doi: 10.1097/JOM.0b013e3181ad49b2. 13. J. F. Gamble, M. J. Nicolich, and P. Boffetta “Lung Cancer and Diesel Exhaust: an Updated Critical Review of the Occupational Epidemiology Literature,” Critical Reviews in Toxicology 42 (2012): 549–598, doi: 10.3109/10408444.2012.690725. 14. C. Bosetti et al., “Formaldehyde and Cancer Risk: A Quantitative Review of Cohort Studies through 2006,” Annals of Oncology 19 (2008): 29–43, doi: 10.1093/annonc/ mdm202. 15. C. Pelucchi et al., “Occupational Silica Exposure and Lung Cancer Risk: a Review of Epidemiological Studies 1996–2005,” Annals of Oncology 17 (2006): 1039–1050, doi: 10.1093/annonc/mdj125. 16. C. La Vecchia and P. Boffetta, “Role of Stopping Exposure and Recent Exposure to Asbestos in the Risk of Mesothelioma,” European Journal of Cancer Prevention 21 (2012): 227–230, doi: 10.1097/CEJ.0b013e32834dbc56.
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17. E. Pira et al., “First and Subsequent Asbestos Exposures in Relation to Mesothelioma and Lung Cancer Mortality,” British Journal of Cancer 97 (2007): 1300-1304, doi: 10.1038/sj.bjc.6603998. 18. C. Pelucchi et al., “Exposure to Acrylamide and Human Cancer—A Review and Meta-analysis of Epidemiologic Studies,” Annals of Oncology 22 (2011): 1487–1499, doi: 10.1093/annonc/mdq610. 19. M. I. Colnaghi (Scientific Director, Italian Association for Cancer Research (AIRC)), Letters of January 20, 2014 and March 6, 2014 to Alessandro Pugno, Associazione Familiari e vittime dell’amianto di Casale Monferrato (Afeva). 20. Istituto di Ricerche Farmacologiche Mario Negri, “Carta dei valori e codice etico” [Mission, Values and Ethical Code of Conduct], http://www.marionegri.it/mn/it/ sezioni/istituto/cartaValoriCodiceEtico/ (accessed April 5, 2014). 21. European Cancer Prevention, “About ECP / History,” http:// ecpo.org/?page_id=396 (accessed April 5, 2014). 22. European Journal of Cancer Prevention, “About the Journal,” http://journals.lww.com/ eurjcancerprev/pages/aboutthejournal.aspx (accessed April 5, 2014). 23. Icahn School of Medicine at Mount Sinai, “Policy on Financial Conflicts of Interest in Research,” http://icahn.mssm.edu/about-us/services-and-resources/faculty-resources/ handbooks-and-policies/faculty-handbook/institutional-policies/policy (accessed August 31, 2014). 24. Icahn School of Medicine at Mount Sinai, “Policy on Business Conflicts of Interest,” http://icahn.nssm.edu/static_files/mssm/Files/About%20Us/Services%20and%20 Resources/Faculty%20Resources/Handbooks%20and%20Policies/Conflict%20of %20Interest/business-coi-policy-82812.pdf (accessed August 31, 2014). 25. “Full Disclosure: Regulatory Agencies Must Demand Conflict-of-Interest Statements for the Research they Use” [editorial], Nature, March 4, 2014, http://www.nature.com/ news/full-disclosure-1.14817 (accessed March 28, 2014). 26. D. S. Egilman et al., “Deconstructing A State-Of-The-Art Review of The Asbestos Brake Industry,” New Solutions 21(4) (2011): 545-571, doi: http://dx.doi.org/10.2190/ NS.21.4.e. 27. J. Morris, The Center for Public Integrity, “America’s Asbestos Age,” http://www. publicintegrity.org/2010/07/21/3425/america-s-asbestos-age (accessed April 21, 2014). 28. Agence française de sécurité sanitaire des produits de santé [French Agency for Health Products Safety], Press Release, “Suspension de l’utilisation des médicaments contenant de la pioglitazone (Actos®, Competact®) Communiqué [Use of medications containing Pioglitazone (Actos®, Competact®) suspended],” June 9, 2011, http://ansm.sante.fr/S-informer/Presse-Communiques-Points-presse/Suspension-del-utilisation-des-medicaments-contenant-de-la-piog (accessed March 31, 2014).
Direct reprint requests to: Kathleen Ruff 215 Highland Road Smithers, BC Canada V0J 2N6 e-mail: [email protected]
Comment and Controversy CONFLICT OF INTEREST, TAILORED SCIENCE, AND RESPONSIBILITY OF SCIENTIFIC INSTITUTIONS AND JOURNALS KATHLEEN RUFF DARIO MIRABELLI
ABSTRACT
Recent revelations have raised concerns on how conflicts of interest may involve even leading scientists and prestigious institutions and lead to bias in reporting and assessing scientific evidence. These have highlighted the need for action to safeguard scientific integrity and public health. The Italian Epidemiology Association has declared that the “biased and deliberately tailored use of the scientific evidence” by scientists with a conflict of interest serves to delay needed measures to prevent harm to public health from a polluting Italian steel plant’s continuing chemical emissions. In France, unresolved concerns over conflict of interest forced the Centre for Research in Epidemiology and Public Health to cancel its imminent appointment of a prominent scientist as its Director. These negative events demonstrate the necessity for scientific institutions and journals to implement rigorous measures regarding conflict of interest and the safeguarding of scientific integrity and public health.
Keywords: worker health and safety, environmental health, science policy, public health history
The ILVA steel plant in Taranto, in southern Italy, is the largest steel plant in Europe and has for years spewed out dioxins, benzo[a]pyrene, and other cancer-causing chemicals from its smokestacks, polluting the land, water, and 259 Ó 2014, Baywood Publishing Co., Inc. doi: http://dx.doi.org/10.2190/NS.EOV http://baywood.com
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neighbourhood around it. The head of the company, Emilio Riva, was twice convicted of environmental offences, but no effective enforcement action was taken by government regulatory agencies to require ILVA to comply with environmental regulations. An Italian court described ILVA as an “environmental disaster.” High levels of air pollution and an excess in lung cancer mortality of approximately 30 percent in the population of Taranto were documented in reports by Italian environmental and health authorities—including the National Health Institute, the regional health authorities, and the scientists appointed by the Taranto court to assess the health consequences for the population and provide a report [1-4]. The court therefore ordered that the plant be put under special administration until the company took action to clean up the contaminated area and to implement pollution controls. Giorgio Assennato, head of the environmental authority for the Puglia region (ARPA), stated to media that the fact that it took the courts to intervene and shut the plant, despite repeated warnings from ARPA and other authorities, laid bare a dangerous weakness in regulatory control. “We have to accept the fact that in Italy you have to turn to the criminal justice system because the system of environmental governance is unbalanced by lobbies, which use improper practices to influence institutions for their own advantage,” said Assennato [5]. Health scientists in Italy have been calling for action to address this continuing environmental and public health catastrophe. Carlo La Vecchia and Paolo Boffetta were hired as consultants by the Riva group, the company that owns ILVA, to assist it in the court case against ILVA. They submitted to the Special Administrator of ILVA a 44-page report, which disputed the findings of the scientists from the National Health Institute, the regional environmental authority, and the court-appointed scientists. In addition, La Vecchia and Boffetta disputed the authority of the regional government’s environmental regulations. La Vecchia and Boffetta’s report exonerated the ILVA steel plant, saying its emissions had not contributed to the excess cancer and respiratory diseases amongst the population of Taranto [6, 7]. CONFLICT OF INTEREST In July 2013, the Italian Epidemiological Association (IEA) issued a press release [8], which described the report by La Vecchia and Boffetta as scientifically flawed and biased—and also noted their conflict of interest, which they had not disclosed in their report. The IEA stated, “The document, signed by consultants for the Riva company disputes the data on the health impact of pollutant emissions and argues that the increased incidence of cancer and chronic respiratory and cardiovascular diseases in Taranto should not be attributed to environmental pollution produced by ILVA but to lifestyle; in particular, the increase in lung cancer should be attributed to cigarette smoking.”
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The IEA expressed strong concern over “the biased and deliberately tailored, pseudo-scientific use of data in order to invalidate the evidence produced to date from epidemiological studies and to disregard the health impact of ILVA emissions on the population and workers.” The IEA media release included the following points. Based on the numerous studies conducted to date in Taranto, the Italian Association of Epidemiology states that: • The environmental data showed that the Taranto population was exposed for decades to high levels of different chemicals with known carcinogenic properties, that are well documented in the scientific literature; • Multicenter epidemiological studies and epidemiological studies of the health impact on populations living in the area have documented that air pollution has led to an increase in mortality and morbidity from heart and respiratory diseases; • The study carried out by the (Italian) National Institute of Health showed an excess mortality for lung cancer in the population of Taranto of approximately 30 percent in both genders (Pirastu et al., 2011); • The most recent epidemiological studies have documented short and long term health effects (mortality from heart diseases and acute coronary events, and a significant increase in mortality from respiratory diseases and cancers in the population 0-14 years); these effects were stronger in most polluted neighborhoods (Tamburi and Borgo) compared to the entire town of Taranto (Mataloni et al., 2012). The IEA stated that “it is a matter of concern that in our country a position can be argued, that is clearly opposed to the evidence produced by international studies and accepted by the World Health Organization. This is a pseudo-scientific position, based on the opinion of individual researchers who are in a position of clear conflict of interest (expert witnesses for ILVA).” The IEA highlighted the urgent need to take action to protect public health: “Finally, the Italian Epidemiological Association considers that the data that has already been produced is sufficient to treat as an urgent matter that cannot be delayed the implementation of measures for abatement of air pollution levels in the area of Taranto, and remediation of contaminated sites, to safeguard the health of the resident population and that of future generations.” RESPONSIBILITY OF SCIENTIFIC INSTITUTIONS AND JOURNALS It is disturbing when scientists, who hold prestigious positions as directors of academic institutions and editors of scientific journals, work as consultants for industries and then write documents that, to advance the financial interests of the industry, misrepresent the scientific evidence and undermine public health
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protection. The prestigious positions they hold in academic organizations and scientific journals lend credibility to the distorted scientific arguments they put forward as industry consultants. Furthermore, such activities conflict with the mission of the institutions and journals they represent, which tell the public that their mission is to safeguard scientific integrity and advance public health protection. Professor Boffetta holds the position of Director of the Institute for Translational Epidemiology and Associate Director for Population Sciences of The Tisch Cancer Institute at Mount Sinai School of Medicine in New York. He is associate editor of Lung Cancer, European Journal of Clinical Investigation, and Frontiers in Cancer Epidemiology, and is a member of more than 10 editorial boards of scientific journals. He is the founding member of several international cancer epidemiology consortia and networks [9]. Professor La Vecchia is an Editor of the European Journal of Cancer Prevention and other journals and is a member of the International Advisory Board of the European Cancer Prevention Organisation. At the time of writing the ILVA document, he was Head of the Department of Epidemiology at Mario Negri Institute. He is also a professor in the Department of Occupational Health of the University of Milan. Boffetta and La Vecchia have, together or separately, written articles denying harm caused by substances that have been recognized by reputable scientific agencies as being carcinogenic or otherwise harmful, such as dioxins, beryllium, formaldehyde, styrene, diesel fumes, silica, and continued exposure to asbestos [10-16]. They have also stated in a number of articles, which denied the carcinogenic effect of substances such as formaldehyde, acrylamide, silica, and continued asbestos exposures, that the Italian Association for Research on Cancer (AIRC) had funded the articles [14-18]. These statements of financial support by AIRC lent the credibility of this cancer association to the articles, but AIRC had provided no funding [19]. Should not scientific institutions and journals, which claim to pursue scientific integrity and public health protection and are accordingly entrusted with public funds, require that scientists they place in leadership positions comply with their stated mission [20-24]? Universities and scientific journals generally recognize a responsibility to guard against scientific work financed or influenced by the tobacco industry, yet some seem to turn a blind eye to distortion of the scientific literature by other industries. A recent editorial on conflict of interest published by the journal Nature [25] makes the critical point that the power balance between industries producing toxic products and those harmed by such products is extremely asymmetric. Workers and their families and impoverished neighbourhoods around the world, who, in particular, are exposed to harm from toxic products, have little economic, social, or political power to stop such injustices or to challenge the corruption of science. Furthermore, while industries pay tens of millions of dollars to hire scientists to protect their financial interests [26, 27], there is
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diminishing public funding for scientists working to defend public health. It would be a better system if, when industries wish to fund research into health effects of toxic substances, they were required to provide the funds to reputable public agencies so as to enable the research to be carried out in an independent manner, free of conflict of interest. Currently, however, independent science that serves the public interest, rather than private profit, is under threat. In light of this imbalance, scientific institutions and journals need to put in place policies to address and stop such abuse. Clearly, they should adopt strict requirements for disclosure of conflicting interests. In addition, warning bells should ring and, at the very least, an independent review should be required, when a scientist, particularly one entrusted with a leadership position, is: 1. working as an industry consultant or working with a consulting company that specializes in carrying out industry-financed studies that deny harm caused by the industries’ products and activities; 2. putting forward scientific work that serves the industry’s interests; 3. showing indifference to or rejection of the precautionary principle; and 4. preventing or impeding occupational and environmental health protections that independent scientists and reputable scientific agencies are calling for. The review should examine whether the scientist’s work conflicts with the stated mission of the institute to uphold the integrity of science and the protection of health. A requirement for holding a leadership position with the institute should be that the scientist does not work against its mission, but instead advances its mission and is an exemplary role model for the upcoming generation of scientists. The National Institute for Health & Medical Research (INSERM) and the University of Paris-Sud (UP-S) in France have recently been forced to address this issue. INSERM and UP-S are responsible for the Centre for Research in Epidemiology and Public Health (CESP), which is France’s coordination centre for public research in epidemiology. They had responsibility for appointing a new Director of CESP, who would assume the position at the end of 2014. Paolo Boffetta was the sole candidate under consideration and about to be appointed as the new Director. The policy in place requires that the Director of CESP should be solely involved in work to advance public health and should have no conflicting interests, such as receiving funds or having contracts with private sources. Boffetta’s candidacy had been criticized by a number of scientists and by the French National Association of Asbestos Victims because of his close ties with industry over recent years and because he had co-authored a series of industry-funded articles, all of which denied harm from the industries’ products, in spite of the fact that these products had been recognized to be carcinogenic by the International Agency for Research on Cancer. Boffetta withdrew from his relationship with a private consulting company (International Prevention Research Services), which carries out research projects
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commissioned by industries. He continued, however, to pursue private consulting, such as for the pharmaceutical company, Takeda, acting as a consultant in an upcoming U.S. court case regarding its anti-diabetic drug, Actos. This drug was withdrawn from the market in France in 2011, following a government study which indicated a risk of bladder cancer [28]. In light of his continuing financial ties to industry, doubts started to be raised at CESP that Boffetta would be an acceptable director. Boffetta withdrew his candidacy. This is an unfortunate and sad example of what may happen if a clear policy of conflict of interest avoidance is not rigorously followed from the very beginning in institutions dedicated to public health protection. It is time to stop turning a blind eye to the issue of conflicting interests. It is time to require that public health, scientific, and academic institutions demonstrate by their actions a genuine commitment to their stated mission to uphold the integrity of science and the protection of health. Editor’s Note: New Solutions requires that contributing authors disclose any competing interests, financial or non-financial (that is, for example, political, personal, commercial, or any other in relation to their manuscripts), and, if uncertain, to “discuss it with the editors.” AUTHORS’ BIOGRAPHIES KATHLEEN RUFF has worked extensively in the field of human rights. She was director of the British Columbia Human Rights Commission and is a founding coordinator of the Rotterdam Convention Alliance. She has published articles in journals, civil society publications and the media on health issues and ethics. She can be contacted at [email protected]. DARIO MIRABELLI is an occupational health physician. He works in the Unit of Cancer Epidemiology, University of Turin (Italy) and Turin teaching hospital, where he is in charge of the regional Registry of Malignant Mesotheliomas. He was expert witness for the public prosecutor in criminal trials where liability of factory managers for asbestos-related deaths among workers was challenged. He can be contacted at: [email protected]. NOTES 1. R. Pirastu et al., “Studio epidemiologico nazionale dei territori e degli insediamenti esposti a rischio da inquinamento: risultati” [Mortality results in SENTIERI Project], Epidemiologia e Prevenzione 35(Suppl 4) (2011): 29-152, http://www.epiprev.it/sites/ default/files/EP2011Sentieri2_lr_bis.pdf (accessed March 31, 2014). 2. P. Comba, S. Conti, I. Iavarone, G. Marsili, L. Musmeci, and R. Pirastu, “Ambiente e salute a Taranto: evidenze disponibili e indicazioni di sanità pubblica” [Environment and health in Taranto: Available Evidence and Public Health Perspectives], http:// www.salute.gov.it/imgs/C_17_pubblicazioni_1833_allegato.pdf (accessed March 28, 2014).
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3. ARPA Puglia, Valutazione del Danno Sanitario Stabilimento ILVA di Taranto ai sensi della LR 21/2012—Scenari emissivi pre-AIA (anno 2010) e post-AIA (anno 2016) [Health Effects Assessment for the ILVA Plant in Taranto According to Regional Law 21/2012: Before (2010) and After (2016) Integrated Environmental Authorization Emission Scenarios], http://www.arpa.puglia.it/web/guest/vds (accessed March 28, 2014). 4. F. Mataloni et al., “Studio di coorte sulla mortalità e morbosità nell’area di Taranto” [A cohort study on mortality and morbidity in the area of Taranto, Southern Italy], Epidemiologia e Prevenzione 36 (2012):237-252. 5. James Mackenzie, “Steel Pollution Case Highlights Italy’s Slow Decline,” Reuters, August 29, 2012, http://www.reuters.com/article/2012/08/29/us-italy-pollution-idUSBRE87S07B20120829 (accessed March 28, 2014). 6. C. La Vecchia and P. Boffetta, “Lo Studio SENTIERI—Elementi di critica” [Critical appraisal of SENTIERI], June 19, 2013, annex 3 to Boffetta et al. [7]. 7. P. Boffetta, C. La Vecchia, M. Lotti, and A. Moretto, Commenti al documento ‘Valutazione del Danno Sanitario Stabilimento ILVA di Taranto ai sensi della LR 21/2012—Scenari emissivi pre-AIA (anno 2010) e post-AIA (anno 2016)’ dell’ARPA Puglia, [Comments on the Document ‘Health Effects Assessment for the ILVA Plant in Taranto According to Regional Law 21/2012: Before (2010) and After (2016) Integrated Environmental Authorization Emission Scenarios], 27 June 2013, http:// www.arpa.puglia.it/web/guest/vds (accessed March 28, 2014). 8. Associazione Italiana di Epidemiologia, “Comunicato stampa dell’AIE sull’ILVA di Taranto” [Press release on ILVA, Taranto], 15 July 2013, http://www.epiprev.it/ comunicato-stampa-dellaie-sullilva-di-taranto (accessed March 28, 2014). 9. Mount Sinai Hospital, “Paolo Boffetta / Biography,” https://www.mountsinai.org/ profiles/paolo-null-boffetta (accessed March 31, 2014). 10. P. Boffetta et al., “TCDD and Cancer: A Critical Review of Epidemiologic Studies” Critical Reviews in Toxicology 41 (2011): 622–636, doi: 10.3109/10408444.2011. 560141. 11. P. Boffetta, J. P. Fryzek, and J. S. Mandel “Occupational Exposure to Beryllium and Cancer Risk: A Review of the Epidemiologic Evidence,” Critical Reviews in Toxicology 42 (2012): 107–118, doi: 10.3109/10408444.2011.631898. 12. P. Boffetta et al., “Epidemiologic Studies of Styrene and Cancer: a Review of the Literature,” Journal of Occupational and Environmental Medicine 51 (2009): 1275–1287, doi: 10.1097/JOM.0b013e3181ad49b2. 13. J. F. Gamble, M. J. Nicolich, and P. Boffetta “Lung Cancer and Diesel Exhaust: an Updated Critical Review of the Occupational Epidemiology Literature,” Critical Reviews in Toxicology 42 (2012): 549–598, doi: 10.3109/10408444.2012.690725. 14. C. Bosetti et al., “Formaldehyde and Cancer Risk: A Quantitative Review of Cohort Studies through 2006,” Annals of Oncology 19 (2008): 29–43, doi: 10.1093/annonc/ mdm202. 15. C. Pelucchi et al., “Occupational Silica Exposure and Lung Cancer Risk: a Review of Epidemiological Studies 1996–2005,” Annals of Oncology 17 (2006): 1039–1050, doi: 10.1093/annonc/mdj125. 16. C. La Vecchia and P. Boffetta, “Role of Stopping Exposure and Recent Exposure to Asbestos in the Risk of Mesothelioma,” European Journal of Cancer Prevention 21 (2012): 227–230, doi: 10.1097/CEJ.0b013e32834dbc56.
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17. E. Pira et al., “First and Subsequent Asbestos Exposures in Relation to Mesothelioma and Lung Cancer Mortality,” British Journal of Cancer 97 (2007): 1300-1304, doi: 10.1038/sj.bjc.6603998. 18. C. Pelucchi et al., “Exposure to Acrylamide and Human Cancer—A Review and Meta-analysis of Epidemiologic Studies,” Annals of Oncology 22 (2011): 1487–1499, doi: 10.1093/annonc/mdq610. 19. M. I. Colnaghi (Scientific Director, Italian Association for Cancer Research (AIRC)), Letters of January 20, 2014 and March 6, 2014 to Alessandro Pugno, Associazione Familiari e vittime dell’amianto di Casale Monferrato (Afeva). 20. Istituto di Ricerche Farmacologiche Mario Negri, “Carta dei valori e codice etico” [Mission, Values and Ethical Code of Conduct], http://www.marionegri.it/mn/it/ sezioni/istituto/cartaValoriCodiceEtico/ (accessed April 5, 2014). 21. European Cancer Prevention, “About ECP / History,” http:// ecpo.org/?page_id=396 (accessed April 5, 2014). 22. European Journal of Cancer Prevention, “About the Journal,” http://journals.lww.com/ eurjcancerprev/pages/aboutthejournal.aspx (accessed April 5, 2014). 23. Icahn School of Medicine at Mount Sinai, “Policy on Financial Conflicts of Interest in Research,” http://icahn.mssm.edu/about-us/services-and-resources/faculty-resources/ handbooks-and-policies/faculty-handbook/institutional-policies/policy (accessed August 31, 2014). 24. Icahn School of Medicine at Mount Sinai, “Policy on Business Conflicts of Interest,” http://icahn.nssm.edu/static_files/mssm/Files/About%20Us/Services%20and%20 Resources/Faculty%20Resources/Handbooks%20and%20Policies/Conflict%20of %20Interest/business-coi-policy-82812.pdf (accessed August 31, 2014). 25. “Full Disclosure: Regulatory Agencies Must Demand Conflict-of-Interest Statements for the Research they Use” [editorial], Nature, March 4, 2014, http://www.nature.com/ news/full-disclosure-1.14817 (accessed March 28, 2014). 26. D. S. Egilman et al., “Deconstructing A State-Of-The-Art Review of The Asbestos Brake Industry,” New Solutions 21(4) (2011): 545-571, doi: http://dx.doi.org/10.2190/ NS.21.4.e. 27. J. Morris, The Center for Public Integrity, “America’s Asbestos Age,” http://www. publicintegrity.org/2010/07/21/3425/america-s-asbestos-age (accessed April 21, 2014). 28. Agence française de sécurité sanitaire des produits de santé [French Agency for Health Products Safety], Press Release, “Suspension de l’utilisation des médicaments contenant de la pioglitazone (Actos®, Competact®) Communiqué [Use of medications containing Pioglitazone (Actos®, Competact®) suspended],” June 9, 2011, http://ansm.sante.fr/S-informer/Presse-Communiques-Points-presse/Suspension-del-utilisation-des-medicaments-contenant-de-la-piog (accessed March 31, 2014).
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