Abstract
Randomised controlled trials (RCTs) are thought to be the gold standard in evidence. This review of their origins and adoption, highlights commonly ignored shortcomings with RCTs. If RCTs are used indiscriminately, their adverse effects may outweigh their benefits. This chapter focuses on antidepressants and how RCTs give the wrong message about safety, efficacy, and effectiveness. The arguments hold true in principle for all treatments, including all treatments for pregnant women. The received wisdom since thalidomide, that we should rarely if ever use drugs in pregnancy, increasingly is being eroded by arguments in support of the use of RCTs. In the case of antidepressants, this has made them among the most commonly prescribed drugs in pregnancy.
There is a presumption that objectivity comes from the procedures of an RCT. We argue that objectivity comes from collective scrutiny of publicly available data and, in the case of pregnancy, this mandates the creation of pregnancy registries to generate sound evidence on the basis of which to make treatment decisions for pregnant women and women of child-bearing years.
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Notes
- 1.
For a discussion of licensing in the face of inadequate, contested data see Healy’s discussion of a decision to license Zoloft on the basis of ghost-written publications stemming from these two positive RCTs, when there were ten or more negative RCTs (Healy 2012).
- 2.
Data available upon request from David Healy.
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Healy, D., Mangin, D. (2016). Does My Bias Look Big in This?. In: Baylis, F., Ballantyne, A. (eds) Clinical Research Involving Pregnant Women. Research Ethics Forum, vol 3. Springer, Cham. https://doi.org/10.1007/978-3-319-26512-4_11
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