Abstract
Financial conflicts of interest in medical research foster deviations from research standards and evidentially lead to the suppression of research findings that are at odds with commercial interests of pharmaceutical companies. Questionable research practices prevent data from being created, made available, or given suitable recognition. They run counter to codified principles of responsible conduct of research, such as honesty, openness or respect for the law. Resulting in ignorance, misrepresentation and suspension of scientific self-correction, suppression of medical evidence in its various forms is both a threat to the epistemic and the moral integrity of medical science. This paper discusses an example of the suppression of medical evidence in recent influenza research and develops a conceptual framework for the description and assessment of questionable research practices applied in research and publication processes to suppress evidence.
Similar content being viewed by others
Notes
http://www.cdc.gov/mmwr/preview/mmwrhtml/00050459.htm, retrieved October 6th, 2016.
http://www.who.int/csr/resources/publications/influenza/whocdscsredc991.pdf, retrieved October 6th, 2016.
http://www.who.int/csr/resources/publications/influenza/11_29_01_A.pdf, reference can be found in Annex 5, p. 7 and was put forward as evidence for efficiency in treatment.
Cf. Romero (2016) who demonstrated in computer simulations, that science is only automatically self-correcting, when ideal conditions like the presence of incentives for replicative research and access to research findings were satisfied.
Martin does in fact acknowledge this and points to the conflict between data suppression and the principle of openness, famously introduced into the discussion by Merton (1973). But I still think Martin´s focus on openness is short-sighted. I will discuss the ethical/moral assessment of the suppression of medical evidence later.
I suggest that concepts in research ethics ought to be defined in a way that easily allows for codification and implementation into institutional policies. Philosophers like Thomas Reydon plead for a narrower scope of research ethics and assign research ethicists first and foremost an advisory role in decision processes. Contrary to such a view, I suggest that research ethicists should take an active role in policy making, an argument for this can be found in my review of Reydon’s otherwise convincing and instructive introduction to research ethics (Reydon 2013).
Since the freedom of science allows within certain limitations for the definition of a research agenda. Under certain conditions, secrecy about research findings can be justified on ethical grounds and even public scrutiny can be illegitimate if it is used to obscure the fact that there is a well-founded consensus on the answer to a scientific question. Proponents of scientific creationism and intelligent design, for example, make use of principles of public scrutiny in science in order to keep an already concluded debate about the existence of biological evolution running.
http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm, retrieved April 9, 2017.
Identifying openness as the principle violated by suppression of evidence is way too uninformative in this context. Saying that suppression of evidence is a problem for openness in science is like saying that violence is a problem for peoples’ safety.
References
Abbasi, K. (2014). The missing data that cost $20bn. BMJ, 348, g2695.
Angell, M. (2004). The truth about the drug companies. New York: Random House.
Barker, E., & Kitcher, P. (2014). Philosohpy of science. New York: Oxford University Press.
Bartens, W. (2014a). Sargnagel für Tamiflu. In Süddeutsche Zeitung (April 10, 2014).
Bartens, W. (2014b). Tamiflu-Skandal: Forscher beklagen Kontrollversagen. In Süddeutsche Zeitung (April 11, 2014).
BMJ. (2000). In brief. BMJ, 321(7273), 1366.
Brown, J. R. (2009). Who rules in science? An opinionated guide to the wars. Cambridge: Harvard University Press.
Charatan, F. (2004). United States prepares for another flu pandemic. BMJ, 329(7465), 532.
Charatan, F. (2005). Bush announces US plan for flu pandemic. BMJ, 331(7525), 1103.
Coombes, R. (2009). A/H1N1 influenza: Questions and answers. BMJ, 338, b1849.
Cunningham, T. V. (2014). Objectivity, scientificity, and the dualist epistemology of medicine. In P. Huneman, G. Lambert, & M. Silberstein (Eds.), Classification, disease and evidence. History, philosophy and theory of the life sciences (pp. 1–17). Dordrecht: Springer.
Day, M. (2005). How the media caught Tamiflu. BMJ, 331(7527), 1277.
Delamothe, T. (2010). Data sharing: Let the sunshine in. BMJ, 340, c1896.
Dickersin, K., & Rennie, D. (2003). Registering clinical trials. JAMA, 290(4), 516–523.
Doshi, P. (2009). Neuraminidase inhibitors-the story behind the Cochrane review. BMJ, 339, b5164.
Doshi, P., Jones, M., & Jefferson, T. (2012). Rethinking credible evidence synthesis. BMJ, 344, d7898.
Doshi, P., Mandl, K. & Bourgeois, F. (2016). Retrieved March 31, 2016, from http://healthaffairs.org/blog/2016/03/31/tamiflu-for-all-evidence-of-morbidity-in-cdcs-antiviral-guidelines/.
Douglas, H. (2004). The irreducible complexity of objectivity. Synthese, 138, 453–473.
Douglas, H. (2009). Science, policy, and the value-free ideal. Pittsburgh: University of Pittsburgh Press.
Dubben, H.-H., & Beck-Bornholdt, H.-P. (2004). Unausgewogene Berichterstattung in der medizinischen Wissenschaft. Hamburg: Institut für Allgemeinmedizin des Universitätsklinikums Hamburg-Eppendorf.
Elliott, C. (2010). White coat black hat. Boston: Beacon Press.
Erklärung (2009). Retrieved June 15, 2016, from https://www.change.org/p/berliner-erklärung-2012-an-die-bürgerinnen-und-bürger-in-europa-die-verheimlichung-von-klinischen-studiendaten-stoppen.
Felser, G., & Klemperer, D. (2011). Psychologische Aspekte von Interessenkonflikten. In K. Lieb, D. Klemperer, & W.-D. Ludwig (Eds.), Interessenkonflikte in der Medizin. Berlin: Springer.
Global Forum for Health Research. (1999). The 10/90 report on health research 1999. Geneva: Global Forum for Health Research.
Godlee, F. (2009a). Pandemic flu: Will there be a second wave? BMJ, 339, b3394.
Godlee, F. (2009b). We want raw data, now. BMJ, 339, b5405.
Godlee, F. (2012a). Open letter to Roche about oseltamivir trial data. BMJ, 345, e7305.
Godlee, F. (2012b). Saving carbon and money. BMJ, 344, e488.
Griffin, A. (2007). The UK H5N1 avian flu outbreak. BMJ, 334(7588), 291.
Gubareva, L. V. (2004). Molecular mechanisms of influenza virus resistance to neuraminidase inhibitors. Virus Research, 103(1–2), 199–203.
Hama, R. (2007). Fifty sudden deaths may be related to central suppression. BMJ, 335(7610), 59.
Henderson, D. (2009). UK government predicts 100,000 new A/H1N1 flu cases a day by September. BMJ, 339, b2721.
Hernán, M. A., & Lipsitch, M. (2011). Oseltamivir and risk of lower respiratory tract complications in patients with flu symptoms: A meta-analysis of eleven randomized clinical trials. Clinical Infectious Diseases, 53(3), 277–279.
Jefferson, T., & Doshi, P. (2010). Time for change, WHO. BMJ, 340, c3461.
Jefferson, T., & Doshi, P. (2014). Multisystem failure: The story of anti-influenza drugs. BMJ, 348(10), g2263.
Jefferson, T., Jones, M. A., Doshi, P., Del Mar, C. B., Dooley, L., Hama, R., & Heneghan, C. J. (2006). Neuraminidase inhibitors for preventing and treating influenza in healthy adults. Cochrane Database of Systematic Reviews, (3), CD001265.
Jefferson, T., et al. (2009). Neuraminidase inhibitors for preventing and treating influenza in healthy adults: Systematic review and meta-analysis. BMJ, 339, b5106.
Jefferson, T., Jones, M. A., Doshi, P., Del Mar, C. B., Hama, R., Thompson, M. J., et al. (2014). Neuraminidase inhibitors for preventing and treating influenza in adults and children. Cochrane Database of Systematic Reviews, (4), CD008965.
Kaiser, L., et al. (2003). Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations. Archives of Internal Medicine, 163(14), 1667–1672.
Kitcher, P. (2001). Science, truth, and democracy. New York: Oxford University Press.
Kmietowicz, Z. (2005). Political lead essential to avoid panic when flu strikes. BMJ, 331(7525), 1099.
Kmietowicz, Z. (2012). GSK backs BMJ’s new policy to publish only studies with full access to data. BMJ, 345, e7404.
Koertge, N. (2000). Science, values, and the values of science. Philosophy of Science, 67, 45–57.
Kriebel, D., et al. (2001). The precautionary principle in environmental science. Environmental Health Perspectives, 109(9), 871–876.
Lieb, K., Klemperer, D., & Ludwig, W.-D. (Eds.). (2011). Interessenkonflikte in der Medizin. Berlin: Springer.
Longino, H. E. (1990). Science as social knowledge: Values and objectivity in scientific enquiry. Princeton: Princeton University Press.
Longino, H. E. (2008). Values, heuristics, and the politics of knowledge. In M. Carrier et al. (Eds.), The challenge of the social and the pressure of practice: Science and values revisited. Pittsburgh: University of Pittsburgh Press.
Martin, B. (1999). Suppressing research data: Methods, context, accountability, and responses. Accountability in Research, 6, 333–372.
Maryon-Davis, A. R. (2010). Data access is matter of trust. BMJ, 340, c134.
Maxwell, S. R. J. (2007). Tamiflu and neuropsychiatric disturbance in adolescents. BMJ, 334(7606), 1232–1233.
Mayor, S. (2006). Review says oseltamivir and zanamivir should be kept for epidemics of flu. BMJ, 332(7535), 196.
Mayor, S. (2009). Resistance of flu virus to oseltamivir is growing, US study shows. BMJ, 338, b995.
Merton, R. K. (1973). The sociology of science. Chicago: University of Chicago Press.
Michaels, D. (2008). Manufactured uncertainty. Contested science and the protection of the public’s health and environment. In R. Proctor & L. L. Schiebinger (Eds.), Agnotology. Stanford: Stanford University Press.
O’Dowd, A. (2009a). A/H1N1 influenza update. BMJ, 339, b2977.
O’Dowd, A. (2009b). Mass information campaign starts in UK as flu cases rise to 28. BMJ, 338, b1857.
O’Dowd, A. (2009c). UK swine flu cases near 3000, as GP leader says use of Tamiflu may need to be rethought. BMJ, 338, b2565.
Ortiz, J. R., et al. (2008). Oseltamivir prescribing in pharmacy-benefits database, United States, 2004–2005. Emerging Infectious Disease Journal, 14(8), 1280–1283.
Pennock, R. T., & O’Rourke, M. (2016). Developing a scientific virtue-based approach to science ethics training. Science and Engineering Ethics, 23, 243–262.
Proctor, R. (2000). The Nazi war on cancer. Princeton: Princeton University Press.
Proctor, R. (2008). Agnotology: A missing term to describe the cultural production of ignorance (and its study). In R. Proctor & L. L. Schiebinger (Eds.), Agnotology. Stanford: Stanford University Press.
Rashford, M. (2009). Roche responds. BMJ, 339, b3758.
Reiser, S. J., & Bulger, R. E. (1997). The social responsibilities of biological scientists. Science and Engineering Ethics, 3(2), 137–143.
Reiss, J. & Sprenger, J. (2014) Scientific objectivity, the Stanford encyclopedia of philosophy (Spring 2017 ed.). In E. N. Zalta (Ed.). <https://plato.stanford.edu/archives/spr2017/entries/scientific-objectivity/>.
Reydon, T. (2013). Wissenschaftsethik. Stuttgart: Verlag Eugen Ulmer.
Roehr, B. (2006). Roche’s tiered pricing enables poorer countries to stockpile drugs. BMJ, 333(7558), 63.
Romero, F. (2016). Can the behavioral sciences self-correct? A social epistemic study. Studies in History and Philosophy of Science Part A, 60, 55–69.
Rosenthal, R. (1979). File drawer problem and tolerance for null results. Psychological Bulletin, 86, 638–641.
Rothstein, H. R., Sutton, A. J., & Borenstein, M. (2006). Publication bias in meta-analysis. Hoboken: Wiley.
Rudner, R. (1953). The scientist qua scientist makes value judgments. Philosophy of Science, 20, 1–6.
Schurz, G. (2014). Philosophy of science. New York: Routledge.
Shamoo, A. E., & Resnik, D. B. (2009). Responsible conduct of research (2nd ed.). Oxford: Oxford University Press.
Shamoo, A. E., & Resnik, D. B. (2015). Responsible conduct of research (3rd ed.). Oxford: Oxford University Press.
Shun-Shin, M., et al. (2009). Neuraminidase inhibitors for treatment and prophylaxis of influenza in children: Systematic review and meta-analysis of randomised controlled trials. BMJ, 339, b3172.
Smith, J. R. (2005). Stockpiling oseltamivir: Roche clarifies data for improved mortality with oseltamivir. BMJ, 331(7526), 1203.
Smith, B., et al. (2002). Structural studies of the resistance of influenza virus neuramindase to inhibitors. Journal of Medicinal Chemistry, 45(11), 2207–2212.
Song, F., Hooper, L., & Loke, Y. K. (2013). Publication bias: What is it? How do we measure it? How do we avoid it? Open Access Journal of Clinical Trials, 5, 71–81.
Stöhr, K. (2003). The global agenda on influenza surveillance and control. Influenza Vaccine, 21(16), 1744–1748.
Thompson, D. F. (1993). Understanding financial conflicts of interest. The New England Journal of Medicine, 329, 573–576.
Torjesen, I. (2012). Europe’s drug agency will publish clinical trial data for new products from 2014. BMJ, 345, e8061.
WHO. (2005). Retrieved April 15, 2016, from http://www.who.int/influenza/resources/documents/h5n1_assessing_pandemic_threat/en/.
WHO. (2016). Retrieved April 15, 2016, from http://www.who.int/mediacentre/news/notes/2015/medical-research-transparency/en/.
Wilholt, T. (2009). Bias and values in scientific research. Studies in History and Philosophy of Science Part B: Studies in History and Philosophy of Modern Physics, 40, 92–101.
Yamey, G. (2000). Drug company issues warning about flu drug. BMJ, 320(7231), 334.
Yamey, G. (2002). The world’s most neglected diseases: Ignored by the pharmaceutical industry and by public-private partnerships. BMJ: British Medical Journal, 325, 167–168.
Zarocostas, J. (2009). World Health Organization declares A (H1N1) influenza pandemic. BMJ, 338, b2425.
Acknowledgements
I would like to thank Frauke Albersmeier for helpful comments on earlier drafts of this article. I also would like to thank Gerhard Schurz, Hartmut Klimt, and Torsten Wilholt for discussing the topic of suppression in medical research with me on several occasions. Furthermore, two anonymous reviewers read the paper carefully and provided me with a kind and constructive feedback, I am very grateful to both of them.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Christian, A. On the Suppression of Medical Evidence. J Gen Philos Sci 48, 395–418 (2017). https://doi.org/10.1007/s10838-017-9377-9
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10838-017-9377-9