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comparing one drug against another, and if you are aware of any impor-
tant areas where we don’t know which of two important treatments is best,
you should submit a request (or if you’re lazy, email it to me).

(37) Hazell L, Shakir SAW. Under-reporting of adverse drug reactions:
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(38) L. Härmark and A. C. Grootheest, ‘Pharmacovigilance: methods,
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(39) FDA warns Pfizer for not reporting side effects—Reuters [Inter-
net]. [cited 2012 May 8]. Available from: http://www.reuters.com/article/
2010/06/10/us-pfizer-fda-idUSTRE6586PE20100610.

(40) Healy D: Let them eat Prozac. New York: New York University
Press; 2004. Furukawa TA: All clinical trials must be reported in detail and
made publicly available. BMJ 2004, 329:626. Via Gøtzsche PC. Why we need
easy access to all data from all clinical trials and how to accomplish it.
Trials. 2011 Nov 23;12(1):249.

(41) Serena Frau et al., ‘Risk Management Plans: are they a tool for
improving drug safety?,’ European Journal of Clinical Pharmacology 66,
no. 8 (June 25, 2010): 785–790.

(42) Giezen TJ, Mantel-Teeuwisse AK, Straus SMJM, Egberts TCG,
Blackburn S, Persson I, et al. Evaluation of post-authorization safety stud-
ies in the first cohort of EU Risk Management Plans at time of regulatory
approval. Drug Saf. 2009;32(12):1175–87.

(43) Andrew Herxheimer, ‘Looking at EU pharmacovigilance,’ European
Journal of Clinical Pharmacology 67, no. 11 (November 2011): 1201-1202.

(44) Schwartz LM, Woloshin S. Communicating Uncertainties About
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(45) EMA Press Office, 2 February 2012, EMA/30803/2012.

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