Under-reporting of Adverse Events in the Biomedical Literature

Ronald N. Kostoff

doi:10.20309/jdis.201623

Journal of Data and Information Science >

2016 , Vol. 1 >Issue 4: 10 - 32

DOI: https://doi.org/10.20309/jdis.201623

Expert Review

Under-reporting of Adverse Events in the Biomedical Literature

Ronald N. Kostoff

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School of Public Policy, Georgia Institute of Technology, Gainesville, VA 20155, USA

Received date: 2016-09-22

Revised date: 2016-09-27

Online published: 2016-09-27

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Abstract

Purpose: To address the under-reporting of research results, with emphasis on the underreporting/distorted reporting of adverse events in the biomedical research literature.
Design/methodology/approach: A four-step approach is used:(1) To identify the characteristics of literature that make it adequate to support policy; (2) to show how each of these characteristics becomes degraded to make inadequate literature; (3) to identify incentives to prevent inadequate literature; and (4) to show policy implications of inadequate literature.
Findings: This review has provided reasons for, and examples of, adverse health effects of myriad substances (1) being under-reported in the premiere biomedical literature, or (2) entering this literature in distorted form. Since there is no way to gauge the extent of this under/distorted-reporting, the quality and credibility of the‘premiere’biomedical literature is unknown. Therefore, any types of meta-analyses or scientometric analyses of this literature will have unknown quality and credibility. The most sophisticated scientometric analysis cannot compensate for a highly flawed database.
Research limitations: The main limitation is in identifying examples of under-reporting. There are many incentives for under-reporting and few dis-incentives.
Practical implications: Almost all research publications, addressing causes of disease, treatments for disease, diagnoses for disease, scientometrics of disease and health issues, and other aspects of healthcare, build upon previous healthcare-related research published. Many researchers will not have laboratories or other capabilities to replicate or validate the published research, and depend almost completely on the integrity of this literature. If the literature is distorted, then future research can be misguided, and health policy recommendations can be ineffective or worse.
Originality/value: This review has examined a much wider range of technical and nontechnical causes for under-reporting of adverse events in the biomedical literature than previous studies.

Key words： Under-reporting; Publication bias; Reporting bias; Manufactured research; Research misconduct; Research malfeasance; Biomedical literature

Cite this article

Ronald N. Kostoff . Under-reporting of Adverse Events in the Biomedical Literature[J]. Journal of Data and Information Science, 2016 , 1(4) : 10 -32 . DOI: 10.20309/jdis.201623

References

Amiri, A.R., Kanesalingam, K., Cro, S., & Casey, A.T.H. (2014). Does source of funding and conflict of interest influence the outcome and quality of spinal research? Spine Journal, 14(2), 308-314.
Angell, M. (2005). The truth about the drug companies:How they deceive us and what to do about it. New York:Random House.
Anonymous. (2012). Corporate influence over clinical research:Considering the alternatives. Prescrire International, 21(129), 191-194.
BA. (2009). Trends in autism and cell phones. Belly Armor. Retrieved on September 22, 2016, from https://www.bellyarmor.com/radiation/health-risks/autism/.
Bero, L.A. (2005). Tobacco industry manipulation of research. Public Health Reports, 120(2), 200-208.
Bloom, S., Smith, P., Stanwyck, C., & Stokley, S. (2006). Has the United States population been adequately vaccinated to achieve rubella elimination? Clinical Infectious Diseases, 43(Suppl 3), 141-145.
Carpenter, D., & Sage, C. (Eds.). (2012). The Bioinitiative Report. Retrieved on September 22, 2016, from http://www.bioinitiative.org/.
Colquhoun, J. (1997). Why I changed my mind about water fluoridation. Perspectives in Biology and Medicine, 41(1), 29-44.
CTDB. (2014). Percentage of children ages 19-35 months receiving the combined series vaccination(4:3:1:3:)+ and the combined series vaccination (4:3:1:3:3:1:)++, 1994-2014. ChildTrends DataBank. Retrieved on September 22, 2016, from http://www.childtrends.org/wp-content/uploads/2014/01/17_fig1.jpg.
Delborne, J.A. (2016). Suppression and dissent in science. In T. Bretag (Ed.), Handbook of Academic Integrity (pp. 943-956). Singapore:Springer.
DeLong, G. (2011). A positive association found between autism prevalence and childhood vaccination uptake across the US population. Journal of Toxicology and Environmental Health:Part A-Current Issues, 74(14), 903-916.
DeStefano, F., Bhasin, T.K., Thompson, W.W., Yeargin-Allsopp, M., & Boyle, C. (2004). Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects:A population-based study in metropolitan Atlanta. Pediatrics, 113(2), 259-266.
Dickson, D. (1984). The new politics of science. New York:Pantheon.
Egilman, D.S., Bird, T., & Lee, C. (2013). MetLife and its corporate allies:Dust diseases and the manipulation of science. International Journal of Occupational and Environmental Health, 19(4), 287-303.
Federal Register. (1993). 40 CFR Part 257 et al. Standards for the use or disposal of sewage sludge:Final rules. Retrieved on September 22, 2016, from http://water.epa.gov/scitech/wastetech/biosolids/upload/fr2-19-93.pdf.
Frickel, S., Gibbon S., Howard, J., Kempner, J., Ottinger, G., & Hess, D. (2010). Undone science:Charting social movement and civil society challenges to research agenda setting. Science, Technology, & Human Values, 35(4), 444-473.
Glantz, S.A., Slade, J., Bero, L.A., Hanauer, P., & Barnes, D.E. (1996). The cigarette papers. Berkeley, CA:University of California Press.
Gøtzsche, P.C. (2013). Deadly medicines and organised crime:How big pharma has corrupted healthcare. London:Radcliffe Publishing.
Grabowski, H., & Wang, Y.R. (2008). Do faster food and drug administration drug reviews adversely affect patient safety? An analysis of the 1992 Prescription Drug User Fee Act. Journal of Law & Economics, 51(2), 377-406.
Hess, D.J. (1999). Suppression, bias, and selection in science:The case of cancer research. Account Research, 6(4), 245-57.
Hirzy, J.W. (1999). The National Treasury Employees Union. Why EPA's headquarters union of scientists opposes fluoridation. Fluoride, 32, 179-186.
Interview. (1995). Interview with EPA's Dr. William Marcus on NTP's Fluoride/Cancer Study. Retrieved on September 22, 2016, from http://fluoridealert.org/content/marcus-interview/.
Jain, A., Marshall, J., Buikema, A., Bancroft, T., Kelly, J.P., & Newschaffer, C.J. (2015). Autism occurrence by MMR vaccine status among US children with older siblings with and without autism. JAMA, 313(15), 1534-1540.
Kassirer, J.P. (2005). On the take:How medicine's complicity with big business can endanger your health. Oxford:Oxford University Press.
Kawashti, M.I.S., Amin, O.R., & Rowehy, N.G. (2006). Possible immunological disorders in autism:Concomitant autoimmunity and immune tolerance. The Egyptian Journal of Immunology, 13(1), 99-104.
Kesselheim, A.S., Wang, B., Franklin, J.M., & Darrow, J.J. (2015). Trends in utilization of FDA expedited drug development and approval programs, 1987-2014:Cohort study. BMJ-British Medical Journal, 351, h4633.
Kostoff, R.N. (2015). Pervasive causes of disease. Georgia Institute of Technology:Atlanta, GA. Retrieved on September 22, 2016, from http://hdl.handle.net/1853/53714.
Kostoff, R.N., & Lau, C.G.Y. (2013). Combined biological and health effects of electromagnetic fields and other agents in the published literature. Technological Forecasting & Social Change, 80(7), 1331-1349.
Krimsky, S. (2003). Science in the private interest:Has the lure of profits corrupted biomedical research? Lanham, MD:Rowman & Littlefield.
Kuehn, R.R. (2004). Suppression of environmental science. American Journal of Law & Medicine, 30(2-3), 333-369.
Kujjo, L.L., Chang, E.A., Pereira, R.J.G., Dhar, S., Marrero-Rosado, B., Sengupta, S., Wang, H., Cibelli, J.B., & Perez, G.I. (2011). Chemotherapy-induced late transgenerational effects in mice. PloS One, 6(3), e17877.
LaDou, J. (2004). The asbestos cancer epidemic. Environmental Health Perspectives, 112(3), 285-290.
Lewis, D.L. (2014). Science for Sale:How the US government uses powerful corporations and leading universities to support government policies, silence top scientists, jeopardize our health, and protect corporate profits. New York, NY:Skyhorse Publishing.
Martin, B. (1999a). Suppressing research data:Methods, context, accountability, and responses. Accountability in Research, 6, 333-372.
Martin, B. (1999b). Suppression of dissent in science. Research in Social Problems and Public Policy, 7, 105-135.
Martin, B. (2015). On the suppression of vaccination dissent. Science and Engineering Ethics, 21(1), 143-157.
McCulloch, J., & Tweedale, G. (2007). Shooting the messenger:The vilification of Irving J. Selikoff. International Journal of Health Services, 37(4), 619-634.
Michaels, D. (2008). Doubt is their product:How industry's assault on science threatens your health (1st Ed). Oxford:Oxford University Press.
Morgan Verkamp (2014). Morgan Verkamp, LLC. Press Release. Statement of William W. Thompson, Ph.D.:Regarding the 2004 article examining the possibility of a relationship between MMR vaccine and autism. Retrieved on September 22, 2016, from http://www.morganverkamp.com/august-27-2014-press-release-statement-of-william-w-thompson-ph-dregarding-the-2004-article-examining-the-possibility-of-a-relationship-between-mmrvaccine-and-autism/.
NaturalNews. (2014). Retrieved on September 22, 2016, from http://www.naturalnews.com/046597_CDC_whistleblower_secret_letter_Julie_Gerberding.html
Newbrun, E., & Horowitz, H. (1999). Why we have not changed our minds about the safety and efficacy of water fluoridation. Perspectives in Biology and Medicine, 42(4), 526-543.
Nilsson, E., Larsen, G., Manikkam, M., Guerrero-Bosagna, C., Savenkova, M.I., & Skinner, M.K.(2012). Environmentally induced epigenetic transgenerational inheritance of ovarian disease. PLoS One, 7(5), e36129.
Nilsson, E.E., & Skinner, M.K. (2015). Environmentally induced epigenetic transgenerational inheritance of disease susceptibility. Transl Research, 165(1), 12-17.
Olson, M.K. (2008). The risk we bear:The effects of review speed and industry user fees on new drug safety. Journal of Health Economics, 27(2), 175-200.
Oreskes, N., & Conway, E.M. (2011). Merchants of doubt:How a handful of scientists obscured the truth on issues from tobacco smoke to global warming. New York, NY:Bloomsbury Press.
Pall, M. L. (2015). The autism epidemic is caused by EMFs, acting via calcium channels and chemicals acting via NMDA-Rs:Downstream effects cause autism. Retrieved on September 22, 2016, from http://www.autismone.org/content/martin-l-pall-ba-phd-autism-epidemiccaused-emfs-acting-calcium-channels-and-chemicals-actin.
Pan, S., An, W., Li, H., & Yang, M. (2014). Using fractional polynomials to estimate the safety threshold of fluoride in drinking water. Journal of Hygiene Research (in Chinese), 43(1), 27-31.
Posey. (2015). Congressman Posey Presentation:CDC Whistleblower. Retrieved on September 22, 2016, from https://www.youtube.com/watch?v=qxr-cv-JuI8.
Primack, J., & von Hippel, F. (1974). Advice and dissent:Scientists in the political arena. New York:Basic Books.
Prystupa, J. (2011). Fluorine-A current literature review. An NRC and ATSDR based review of safety standards for exposure to fluorine and fluorides. Toxicology Mechanisms And Methods, 21(2), 103-170.
Rosenberg, M. (2012). Former FDA reviewer speaks out about intimidation, retaliation and marginalizing of safety. Truthout. Retrieved on September 22, 2016, from http://www.truth-out.org/news/item/10524-former-fda-reviewer-speaks-out-about-intimidation-retaliation-andmarginalizing-of-safety.
Schumm, W.R. (2015). Navigating treacherous waters-one researcher's 40 years of experience with controversial scientific research. Comprehensive Psychology, 4, Article 24. Retrieved on September 22, 2016, from http://cop.sagepub.com/cgi/content/full/4/0/17.CP.4.24.
Scutti, S. (2015). Autism rates to increase by 2025? Glyphosate herbicide may be responsible for future half of children with autism. Medical Daily. Retrieved on September 22, 2016, from http://www.medicaldaily.com/autism-rates-increase-2025-glyphosate-herbicide-may-beresponsible-future-half-316388.
Seife, C. (2015a). Research misconduct identified by the US Food and Drug Administration:Out of sight, out of mind, out of the peer-reviewed literature. JAMA Internal Medicine, 175(4), 567-577.
Seife, C. (2015b). Are your medications safe? Slate. Retrieved on September 22, 2016, from http://www.slate.com/articles/health_and_science/science/2015/02/fda_inspections_fraud_fabrication_and_scientific_misconduct_are_hidden_from.single.html
Singh, V.K., Lin, S.X., Newell, E., & Nelson, C. (2002). Abnormal measles-mumps-rubella antibodies and CNS autoimmunity in children with autism. Journal of Biomedical Science, 9(4), 359-364.
Slesin, L. (2006). "Radiation Research" and the cult of negative results. Microwave News. Retrieved on September 22, 2016, from http://microwavenews.com/RR.html.
Taylor, L.E., Swerdfeger, A.L., & Eslick, G.D. (2014). Vaccines are not associated with autism:An evidence-based meta-analysis of case-control and cohort studies. Vaccine, 32(29), 3623-3629.
Vactruth. (2013). History of vaccine schedule. Retrieved on September 22, 2016, from https://vactruth.com/history-of-vaccine-schedule/.
Wakefield, A.J., Murch, S.H., Anthony, A., Linnell, J., Casson, D.M., Malik, M., Berelowitz, M., Dhillon, A.P., Thomson, M.A., Harvey, P., Valentine, A., Davies, S.E., & Walker-Smith, J.A.(1998). Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet, 351(9103), 637-641.
Yeung, C.A. (2008). A systematic review of the efficacy and safety of fluoridation. Evidence-based Dentistry, 9(2), 39-43.
Zeh, J.A., Bonilla, M.M., Adrian, A.J., Mesfin, S., & Zeh, D.W. (2012). From father to son:Transgenerational effect of tetracycline on sperm viability. Scientific Reports, 2, Article No. 375. Retrieved on September 22, 2016, from http://www.nature.com/articles/srep00375.

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