Showing papers by "Rodolfo Saracci published in 2009"

Epidemiology, Public Health, and the Rhetoric of False Positives

Abstract: BACKGROUND: As an observational science, epidemiology is regarded by some researchers as inherently flawed and open to false results. In a recent paper, Boffetta et al. [Boffetta P, McLaughlin JK, LaVecchia C, Tarone RE, Lipworth L, Blot WJ. False-positive results in cancer epidemiology: a plea for epistemological modesty. J Natl Cancer Inst 100:988-995 (2008)] argued that "epidemiology is particularly prone to the generation of false-positive results." They also said "the tendency to emphasize and over-interpret what appear to be new findings is commonplace, perhaps in part because of a belief that the findings provide information that may ultimately improve public health" and that "this tendency to hype new findings increases the likelihood of downplaying inconsistencies within the data or any lack of concordance with other sources of evidence." The authors supported these serious charges against epidemiology and epidemiologists with few examples. Although we acknowledge that false positives do occur, we view the position of Boffetta and colleagues on false positives as unbalanced and potentially harmful to public health. OBJECTIVE: We aim to provide a more balanced evaluation of epidemiology and its contribution to public health discourse. DISCUSSION: Boffetta and colleagues ignore the fact that false negatives may arise from the very processes that they tout as generating false-positive results. We further disagree with their proposition that false-positive results from a single study will lead to faulty decision making in matters of public health importance. In practice, such public health evaluations are based on all the data available from all relevant disciplines and never to our knowledge on a single study. CONCLUSIONS: The lack of balance by Boffetta and colleagues in their evaluation of the impact of false-positive findings on epidemiology, the charge that "methodological vigilance is often absent" in epidemiologists' interpretation of their own results, and the false characterization of how epidemiologic findings are used in societal decision making all undermine a major source of information regarding disease risks. We reaffirm the importance of epidemiologic evidence as a critical component of the foundation of public health protection.

International collaborations in cancer control and the Third International Cancer Control Congress

Abstract: Over the past few decades, there has been growing support for the idea that cancer needs an interdisciplinary approach. Therefore, the international cancer community has developed several strategies as outlined in the WHO non-communicable diseases Action Plan (which includes cancer control) as the World Health Assembly and the UICC World Cancer Declaration, which both include primary prevention, early diagnosis, treatment, and palliative care. This paper highlights experiences/ideas in cancer control for international collaborations between low, middle, and high income countries, including collaborations between the European Union (EU) and African Union (AU) Member States, the Latin-American and Caribbean countries, and the Eastern Mediterranean countries. These proposals are presented within the context of the global vision on cancer control set forth by WHO in partnership with the International Union Against Cancer (UICC), in addition to issues that should be considered for collaborations at the global level: cancer survival (similar to the project CONCORD), cancer control for youth and adaptation of Clinical Practice Guidelines. Since cancer control is given lower priority on the health agenda of low and middle income countries and is less represented in global health efforts in those countries, EU and AU cancer stakeholders are working to put cancer control on the agenda of the EU-AU treaty for collaborations, and are proposing to consider palliative care, population-based cancer registration, and training and education focusing on primary prevention as core tools. A Community of Practice, such as the Third International Cancer Control Congress (ICCC-3), is an ideal place to share new proposals, learn from other experiences, and formulate new ideas. The aim of the ICCC-3 is to foster new international collaborations to promote cancer control actions in low and middle income countries. The development of supranational collaborations has been hindered by the fact that cancer control is not part of the objectives of the Millennium Development Goals (MGGs). As a consequence, less resources of development aids are allocated to control NCDs including cancer.

Commentary: Can we facilitate the ethical approval of international observational studies?

Abstract: icinal products for human use. 5 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. 6 International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. February 2006. http://www.icmje.org/ (10 July 2007, date last accessed). 7 Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. 2002. http:// www.cioms.ch/frame_guidelines_nov_2002.htm (10 July 2007, date last accessed). 8 Act No. 78-17 of 6 January 1978 on Data Processing, Data Files and Individual Liberties (Amended by the Act of 6 August 2004 Relating to the Protection of Individuals With Regard to the Processing of Personal Data). 2004. www.cnil.fr/fileadmin/ documents/uk/78-17VA.pdf (10 July 2007, date last accessed). 9 IEA. Good Epidemiological Practice (GEP) Conduct in Epidemiologic Research. 2007. http://www.dundee.ac.uk/ iea/GEP07.htm (10 July 2007, date last accessed). 10 European Commission-European Medicines Agency. Report on the Conference on the Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future. 2007. http://www.emea.europa.eu/pdfs/ conferenceflyers/clinicaltrials/report.pdf (3 February 2008, date last accessed).

Protection of health information in Italy: a step too far?

Abstract: A recent appeal by a group of Italian obstetricians and neonatologists, advocating full resuscitation of extremely preterm infants independently from parental opinion, raised a debate on the rationale and consequences of such proposal. Whether or not the appeal will modify practices, there is no doubt that careful assessment of outcome for these very special infants is called for. However, this is currently impossible at national level in Italy. Following a change in legislation, the time-honoured system of births monitoring by the Italian National Institute of Statistics (ISTAT) was dismantled in 1998 and later rebuilt entrusting it to the Ministry of Health, while ISTAT remains in charge of deaths registry. Both are public institutions; yet for privacy protection the transfer of birth certificates from the Ministry to ISTAT is only permitted after deletion of personal identifiers. Thus, the individual matching of birth certificates, containing crucial information such as birthweight, gestational age and vitality, to the corresponding infant death data (if any) becomes more difficult. Results of an attempt of statistical record linkage performed on the 2003 birth cohort are shown in Table 1. Variables used as keys to record linkage were infant’s gender, plurality, date and place of delivery and maternal date of birth. Overall, only 598 of the 1539 deaths (38.9%) could be successfully linked, and proportions decreased from 56.6% in the North to 32% in the Centre and South, to only 15% in the Islands. Both missing birth certificates and records incompleteness on linkage variables contributed to these results. The lower proportion of valid death records determined linking difficulties in Central Italy, while missing birth certificates were the main issue in the South and especially Islands. At the light of the North-to-South trend of neonatal and infant mortality traditionally reported in Italy, lack of information from the Southern regions is particularly troubling. As stated by the Europeristat project, neonatal and infant mortality stratified by birthweight and gestational age are ‘core’ indicators to be recorded by all European Union countries to assess the quality of perinatal care and monitor the effects of policy changes. Voluntary collection of data by Neonatal Intensive Care Units, as developing today in Italy and other countries for benchmarking purposes, is a useful but inadequate substitute, being based on the selected subgroup of neonates surviving to admission to tertiary Centres. Solutions are urgently needed to reconcile privacy protection with timely population-based monitoring of neonatal and infant outcomes stratified by birthweight and gestational age.

Epidemiology's contributions to a Nobel Prize recognition.

Abstract: The Nobel Prize Committee awarded last year's Physiology and Medicine prize to 3 sci ntists wh identified the causes of 2 diseases that kill millions of people world wide: HIV/AIDS and cancer of the cervix. Harald zur Hausen received half of the prize "for his discovery of human papilloma viruses causing cervical cancer" and Franchise Barre-Sinoussi and Luc Montagnier shared the other half of the award "for their discovery of human immunodeficiency virus."1 The knowledge that stemmed directly or indirectly from the vigorous research by these 3 outstanding scientists will prevent the countless premature deaths caused by these diseases. As epidemiologists working in public health on the global scene, we applaud the Nobel Committee's decision. We hasten to add, however, that in this era in which advances in medical knowledge can come only from strong multidisciplinary approaches, the laurels of recognition to those who initiate or sustain the basic science discoveries are grounded on a foundation of public health science. Our arguments, summarized later, are self serving. The 4 of us are card-carrying epidemiologists who have witnessed how the monumental work of the 3 Nobel laureates was validated and brought to the attention of the public and the pharmaceutical and biotechnology sector by a massive public health research undertaking championed by epidemiologists. That the Nobel Committee has chosen not to add the names of such champions is more or less understandable. The Committee has a track record of rewarding primarily the forebears of the scientific domains that led to the medical advances. There are many candidates competing for science's highest accolade, and there is only one Nobel Prize given each year in Medicine. Packaging 2 diseases into the 2008 award may have helped the Nobel Committee deal with the backlog of eminent scientists who must be recognized with as little delay as possible (the rules of the award state that the prize cannot be given posthumously). Without questioning the Nobel's modus operandi (the very glamour of the prize rests in the organization's aura of tradition and independence in reaching its decisions), we feel that the readers of Epidemiology will find comfort in being reminded of the contribution of their discipline in the accomplishments that led to a Nobel recognition in 2008, and that ultimately enabled the Nobel-Prize-winners' work to have impact. Over history, epidemiologic studies have made many of the observations that were necessary for getting the right hypotheses to bear fruit in terms of health interventions. Robert Koch was given the Nobel Prize in 1905 for his work in tuberculosis, but he could also have received the prize for his isolation of the Vibrio cholerae. Had the Nobel Committee awarded the prize for cholera, according to their current practice they would have left out John Snow who elegantly demonstrated where the infectious agent came from, how it spread and how it could be prevented. One of the lines of inquiry of the last century with most influence on public health intervention was the demonstration of the carcinogenic role of tobacco smoking. The list of pioneer epidemiologists who cham

Virchow, a model for epidemiologists

Abstract: In the history of medicine, Rudolph Virchow (1821–1902) stands as “the greatest of all pathologists…in every way an intellectual giant”.1 Mackenbach’s review2 is a well-argued step in going beyond the pathology dimension, illuminating Virchow’s role in epidemiology and public health ( see page 181 ). When opening courses in epidemiology, I never miss the opportunity to refer to Virchow, stressing the key feature that in my view makes him a permanent model for epidemiologists: his breadth and force of synthesis, expressed both intellectually within his scientific work and behaviourally in joining science with civic engagement. Throughout his long career, Virchow, the founder of cellular pathology, carried out thousands of necropsies, and his power of analysis, based on meticulous macroscopic and microscopic observations, was matched by the power of integrating, within an essentially physiological framework, notions at different levels of biological complexity, from chemistry to the population. In Virchow’s words,3: > When I directed attention to the cell, I wished to coerce research workers to discover exactly the process inside the cell, the happenings inside the smallest elementary organism, and it was self-evident that continued …

Epidemiology and the Nobel prize

Abstract: Alfredo Morabia’s insightful commentary1 on epidemiologists and the Nobel prize reaches a sensitive nerve, going deeper than just the prize question. Every time a Nobel winner is chosen, there are a number of factors at play: the rule that no more than three living winners can be designated for a discovery; the latitude in defining a discovery, as exemplified in 2008 by the choice of putting together scientists who have identified the viral causes of two (mainly) sexually transmitted but very different diseases, AIDS and cervical cancer; less palpable and indirect academic and political influences and, inevitably, the subjectivity of the jury. None of these factors however would go an inch towards explaining why epidemiologists who have without any question made huge contributions to health improvement (or, in words from Alfred Nobel’s will, to “…the greatest benefit on …