Skip to main content

Advertisement

Log in

Parachutes, randomized controlled trials, and all-cause mortality

  • Notes & Comments
  • Published:
History and Philosophy of the Life Sciences Aims and scope Submit manuscript

Abstract

In 2003 and 2018 researchers discussed the perils of blind reliance on randomized controlled trials that have been substituted for medical experience and clinical acumen. Although these past articles do well to shed light on this issue, they neglect to discuss the topic of all-cause mortality in controlled trials. The current essay seeks to fill this void and expand the thought put into the appropriateness of all-cause mortality, especially when trials extend excessively far into the future. To do this effectively the current essay leans on trial data from statin research and evidence from cancer screening—where researchers have explicitly called for all-cause mortality to be used in lieu of cancer or cardiovascular specific mortality. The issue with such an endpoint is that it obfuscates the issue at hand, namely that a specific intervention is intended to have a specific effect, not that a specific intervention is supposed to have any kind of effect. The effect(s) of medical interventions ought to be relevant to their intended mechanism of action and not simply any positive effect that can be pulled from trial data.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

References

  • Black, W. C., Haggstrom, D. A., & Welch, H. Gilbert (2002). All-cause mortality in randomized trials of cancer screening. Journal of the National Cancer Institute, 3(February), 167–173. https://doi.org/10.1093/jnci/94.3.167.

  • Habib, A. R., Katz, Mitchell H., & Redberg, Rita F. (2022). Statins for primary cardiovascular disease prevention. JAMA Internal Medicine, August. Advance online publication https://doi.org/10.1001/jamainternmed.2022.3204.

  • Kendrick, M. (2021). The clot thickens: The enduring mystery of heart disease. Columbus Publishing.

  • Kendrick, M. (2018). A statin nation: Damaging millions in a brave new post-health world. John Blake Publishing.

  • Mansi, I. A., Chansard, M., Lingvay, I., Zhang, S., Halm, E. A., & Alvarez, C. A. (2021). Association of statin therapy initiation with diabetes progression: A retrospective matched-cohort study. JAMA Internal Medicine, 12(December), 1562–1574. https://doi.org/10.1001/jamainternmed.2021.5714.

  • Murphy, S. L., Kochanek, K. D., Xu, J. Q., & Arias, E. (2021). Mortality in the United States, 2020. NCHS Data Brief, no 427. Hyattsville, MD: National Center for Health Statistics. https://doi.org/10.15620/cdc:112079

  • Nayak, A., Hayen, A., Zhu, L., McGeechan, K., Glasziou, P., Irwig, L., Doust, J., Gregory, G., & Bell, K. (2018). Legacy effects of statins on cardiovascular and all-cause mortality: A meta-analysis. British Medical Journal Open, 9(September), e020584. https://doi.org/10.1136/bmjopen-2017-020584.

  • Orkaby, A. R., Jane, A., Driver, Y. L., Ho, B., Lu, L., Costa, J., Honerlaw, A., Galloway, et al. (2020). Association of statin use with all-cause and cardiovascular mortality in US veterans 75 years and older. Journal of the American Medical Association, 324(1), 68–78. https://doi.org/10.1001/jama.2020.7848.

  • Penston, J. (2011). Should we use total mortality rather than cancer specific mortality to judge cancer screening programmes? Yes. BMJ, 343, d6395. https://doi.org/10.1136/bmj.d6395.

  • Prasad, V., Lenzer, J., & Newman, David H. (2016). Why cancer screening has never been shown to ‘save lives’—and what we can do about it. BMJ, 352, h6080. https://doi.org/10.1136/bmj.h6080.

  • Ray, K. K., Seshasai, S., Erqou, S., Jukema, J. W., Ford, I., & Sattar, Naveed (2010). Statins and all-cause mortality in high-risk primary prevention. Archives of Internal Medicine, 12 (June), 1024. https://doi.org/10.1001/archinternmed.2010.182.

  • Shaukat, A., Steven J. M., Mindy S. G., Frank A. L., John H. B., Mandel, J. S., & Timothy R. C. (2013). Long-term mortality after screening for colorectal cancer. New England Journal of Medicine, 12, 1106–1114. https://doi.org/10.1056/nejmoa1300720.

  • Simmons, J. P., Nelson, Leif D., & Simonsohn, U. (2011). False-positive psychology. Psychological Science, 11 (October), 1359–1366. https://doi.org/10.1177/0956797611417632.

  • Smith, G. C. S., & Pell, Jill P. (2003). Parachute use to prevent death and major trauma related to gravitational challenge: Systematic review of randomised controlled trials. BMJ, 7429(December), 1459–1461. https://doi.org/10.1136/bmj.327.7429.1459.

  • Welch, H. Gilbert, Schwartz, L., & Woloshin, S. (2011). Overdiagnosed: Making people sick in the pursuit of health. Beacon Press.

  • Wicherts, J. M., Veldkamp, Coosje L. S., Augusteijn, Hilde E. M., Bakker, M., van Aert, Robbie C. M., & van Assen, Marcel A. L. M. (2016). Degrees of freedom in planning, running, analyzing, and reporting psychological studies: A checklist to avoid p-hacking. Frontiers in Psychology. https://doi.org/10.3389/fpsyg.2016.01832.

  • Yeh, Robert W, Valsdottir, Linda R., Yeh, M. W., Shen, C., Kramer, Daniel B., Strom, J. B., Secemsky, Eric A., Healy, Joanne L., Domeier, Robert M., Kazi, Dhruv S., Nallamothu, Brahmajee K. (2018). Parachute use to prevent death and major trauma when jumping from aircraft: Randomized controlled trial. BMJ, 363, k5094. https://doi.org/10.1136/bmj.k5094.

Download references

Funding

None to disclose.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Thomas Milovac.

Ethics declarations

Conflict of interest

None to disclose.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Milovac, T. Parachutes, randomized controlled trials, and all-cause mortality. HPLS 44, 68 (2022). https://doi.org/10.1007/s40656-022-00551-6

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s40656-022-00551-6

Keywords

Navigation