Skip to main content
Top
Published in: BMC Medicine 1/2015

Open Access 01-12-2015 | Commentary

Why are there deadly drugs?

Author: Joel Lexchin

Published in: BMC Medicine | Issue 1/2015

Login to get access

Abstract

Some drugs eventually have to be removed from the market because of a negative benefit-to-harm ratio, including an excess of mortality. Drug safety is the result of multiple factors, commencing with how clinical trials are designed, the information generated by and/or hidden through these trials, trial analysis by drug regulatory authorities (DRAs) and the amount of information that DRAs choose to release, the amount of published information regarding drug safety, the effectiveness of postmarket surveillance systems in recognizing and reporting adverse drug reactions, and the structure of DRAs such as the United States Food and Drug Administration and its equivalent in other countries. This commentary will look at each of these issues in order to highlight the problems in the current approach to drug safety and finally indicate how some of these deficiencies should be addressed.
Literature
1.
go back to reference Onakpoya I, Heneghan C, Aronson J. Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis. BMC Medicine 2015. Onakpoya I, Heneghan C, Aronson J. Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis. BMC Medicine 2015.
2.
go back to reference Friedman M, Woodcock J, Lumpkin M, Shuren J, Hass A, Thompson L. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA. 1999;281:1728–34.CrossRefPubMed Friedman M, Woodcock J, Lumpkin M, Shuren J, Hass A, Thompson L. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA. 1999;281:1728–34.CrossRefPubMed
3.
go back to reference World Health Organization. The world medicines situation report. Geneva: WHO; 2004. World Health Organization. The world medicines situation report. Geneva: WHO; 2004.
4.
go back to reference Pal S, Dodoo A, Mantel A, Olsson S. The world medicines situation 2011: pharmacovigilance and safety of medicines. Geneva: WHO; 2011. Pal S, Dodoo A, Mantel A, Olsson S. The world medicines situation 2011: pharmacovigilance and safety of medicines. Geneva: WHO; 2011.
5.
go back to reference Kamal-Yanni M, Saunders P. Urgent need for WHO’s reform to prioritise core functions. Lancet. 2012;379:1878. Kamal-Yanni M, Saunders P. Urgent need for WHO’s reform to prioritise core functions. Lancet. 2012;379:1878.
6.
go back to reference Lurie P, Wofle SM. Misleading data analyses in salmeterol (SMART) study. Lancet. 2005;366:1261–2.CrossRefPubMed Lurie P, Wofle SM. Misleading data analyses in salmeterol (SMART) study. Lancet. 2005;366:1261–2.CrossRefPubMed
7.
go back to reference Psaty BM, Kronmal RA. Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation. JAMA. 2008;299:1813–7.CrossRefPubMed Psaty BM, Kronmal RA. Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation. JAMA. 2008;299:1813–7.CrossRefPubMed
8.
go back to reference Woloshin S, Schwartz L. Bringing the FDA’s information to market. Arch Intern Med. 2009;169:1985–7.CrossRefPubMed Woloshin S, Schwartz L. Bringing the FDA’s information to market. Arch Intern Med. 2009;169:1985–7.CrossRefPubMed
9.
go back to reference Habibi R, Lexchin J. Quality and quantity of information in summary basis of decision documents issued by health Canada. PLoS One. 2014;9:e92038. Habibi R, Lexchin J. Quality and quantity of information in summary basis of decision documents issued by health Canada. PLoS One. 2014;9:e92038.
10.
go back to reference Barbui C, Baschirotto C, Cipriani A. EMA must improve the quality of its clinical trial reports. BMJ. 2011;342:d2291. Barbui C, Baschirotto C, Cipriani A. EMA must improve the quality of its clinical trial reports. BMJ. 2011;342:d2291.
11.
go back to reference Carpenter D, Zucker E, Avorn J. Drug-review deadlines and safety problems. New Engl J Med. 2008;358:1354–61.CrossRefPubMed Carpenter D, Zucker E, Avorn J. Drug-review deadlines and safety problems. New Engl J Med. 2008;358:1354–61.CrossRefPubMed
12.
go back to reference Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Arch Intern Med. 2012;172:1680–1.CrossRefPubMed Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Arch Intern Med. 2012;172:1680–1.CrossRefPubMed
13.
go back to reference Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009;169:1756–61.CrossRefPubMed Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009;169:1756–61.CrossRefPubMed
14.
go back to reference Breau R, Gaboury I, Scales C, Fesperman S, Watterson J, Dahm P. Reporting of harm in randomized controlled trials published in the urological literature. J Urol. 2010;183:1693–7.CrossRefPubMed Breau R, Gaboury I, Scales C, Fesperman S, Watterson J, Dahm P. Reporting of harm in randomized controlled trials published in the urological literature. J Urol. 2010;183:1693–7.CrossRefPubMed
15.
go back to reference Hazell L, Shakir S. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29:385–96.CrossRefPubMed Hazell L, Shakir S. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29:385–96.CrossRefPubMed
16.
go back to reference Mittmann N, Knowles S, Gomez M, Fish J, Cartotto R, Shear N. Evaluation of the extent of under-reporting of serious adverse drug reactions: the case of toxic epidermal necrolysis. Drug Saf. 2004;27:477–87.CrossRefPubMed Mittmann N, Knowles S, Gomez M, Fish J, Cartotto R, Shear N. Evaluation of the extent of under-reporting of serious adverse drug reactions: the case of toxic epidermal necrolysis. Drug Saf. 2004;27:477–87.CrossRefPubMed
17.
go back to reference Moore T, Cohen M, Furberg C. Serious adverse drug events reported to the Food and Drug Administration, 1998–2005. Arch Intern Med. 2007;167:1752–9.CrossRefPubMed Moore T, Cohen M, Furberg C. Serious adverse drug events reported to the Food and Drug Administration, 1998–2005. Arch Intern Med. 2007;167:1752–9.CrossRefPubMed
18.
go back to reference Mundy A. Dispensing with the truth: the victims, the drug companies, and the dramatic story behind the battle over fen-phen. New York: St. Martin’s Press; 2001. Mundy A. Dispensing with the truth: the victims, the drug companies, and the dramatic story behind the battle over fen-phen. New York: St. Martin’s Press; 2001.
19.
go back to reference Wiktorowicz M, Lexchin J, Moscou K, Silversides A, Eggertson L. Keeping an eye on prescription drugs, keeping Canadians safe: active monitoring systems for drug safety and effectiveness in Canada and internationally. Toronto: Health Council of Canada; 2010. Wiktorowicz M, Lexchin J, Moscou K, Silversides A, Eggertson L. Keeping an eye on prescription drugs, keeping Canadians safe: active monitoring systems for drug safety and effectiveness in Canada and internationally. Toronto: Health Council of Canada; 2010.
20.
go back to reference Carpenter D. Reputation and power: organizational image and pharmaceutical regulation at the FDA. Princeton University Press: Princeton; 2010. Carpenter D. Reputation and power: organizational image and pharmaceutical regulation at the FDA. Princeton University Press: Princeton; 2010.
Metadata
Title
Why are there deadly drugs?
Author
Joel Lexchin
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Medicine / Issue 1/2015
Electronic ISSN: 1741-7015
DOI
https://doi.org/10.1186/s12916-015-0270-2

Other articles of this Issue 1/2015

BMC Medicine 1/2015 Go to the issue