Medicine is broken – Ben Goldacre

Side Effects May Include

Gemma Hill

The Problem

Publication Bias/File Drawer Problem

Cochrane module on publication bias

Case Study

Lorcainide, however, is not tolerated well and affords less protection against a sudden death recurrence than is noted in a population on other anti-arrhythmic therapy.(Somberg et al., 1986)

Trial Registration

Trial registration = greater accountability

Date of download: 3/9/2013Copyright © 2012 American Medical Association. All

rights reserved.

From: Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials

JAMA. 2009;302(9):977-984. doi:10.1001/jama.2009.1242

RCT indicates randomized clinical trials.

Figure Legend:

GSK fine

GSK pledges to publish clinical trial data

GSK chief apologises

GSK fined $3bn for misbehaviour

What Has Been Done?

and EudraPharm

Clinicaltrials.gov Only lists results for studies registered since 2008

Does not list results, and only certain study data

EudraCT

What Can Be Done?

The Petition

http://www.alltrials.net/

References and Further ReadingBourgeois, F.T., Murthy, S., Mandl, K.D., 2010. Outcome Reporting Among Drug

Trials Registered in ClinicalTrials.gov. Annals of Internal Medicine 153, 158–166.

Cameron, H., Waller, P., Ramsay, L., 1988. Drug treatment of intermittent claudication: a critical analysis of the methods and findings of published clinical trials, 1965-1985 [see comments]. British Journal of Clinical Pharmacology 26, 569–576.

Goldacre, B., 2012. Bad Pharma. FOURTH ESTATE LTD, London.

Hopewell, S., Loudon, K., Clarke, M.J., Oxman, A.D., Dickersin, K., 2009. Publication bias in clinical trials due to statistical significance or direction of trial results, in: The Cochrane Collaboration, Hopewell, S. (Eds.), Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd, Chichester, UK.

Kirkham, J.J., Dwan, K.M., Altman, D.G., Gamble, C., Dodd, S., Smyth, R., Williamson, P.R., 2010. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ 340, c365–c365.

Mathieu S, B.I., 2009. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 302, 977–984.

Somberg, J.C., Laux, B., Wynn, J., Keefe, D., Miura, D.S., 1986. Lorcainide therapy in a cardiac arrest population. Am. Heart J. 111, 648–653.

Gemma Hill @gem_hill

#bracamp @mcrgirlgeeks

@MadLabUK