Why are there deadly drugs?

BMC Medicine

Joel Lexchin¹ 

[1] School of Health Policy and Management, York University, 4700 Keele St., Toronto M3J 1P3, Ontario, Canada

关键词: Pharmaceutical company;    Drug safety;    Drug regulatory authority;    Clinical trials;    Adverse drug reactions;   

Others  :  1118649
DOI  :  10.1186/s12916-015-0270-2

 received in 2015-01-07, accepted in 2015-01-07,  发布年份 2015

【 摘 要 】

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.

Please see related article: http://dx.doi.org/10.1186/s12916-014-0262-7 webcite

【 授权许可】

   
2015 Lexchin; licensee BioMed Central.

【 参考文献 】

• [1]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]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.
• [3]World Health Organization: The world medicines situation report. WHO, Geneva; 2004.
• [4]Pal S, Dodoo A, Mantel A, Olsson S: The world medicines situation 2011: pharmacovigilance and safety of medicines. WHO, Geneva; 2011.
• [5]Kamal-Yanni M, Saunders P. Urgent need for WHO’s reform to prioritise core functions. Lancet. 2012;379:1878.
• [6]Lurie P, Wofle SM: Misleading data analyses in salmeterol (SMART) study. Lancet 2005, 366:1261-2.
• [7]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.
• [8]Woloshin S, Schwartz L: Bringing the FDA’s information to market. Arch Intern Med 2009, 169:1985-7.
• [9]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]Barbui C, Baschirotto C, Cipriani A. EMA must improve the quality of its clinical trial reports. BMJ. 2011;342:d2291.
• [11]Carpenter D, Zucker E, Avorn J: Drug-review deadlines and safety problems. New Engl J Med 2008, 358:1354-61.
• [12]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.
• [13]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.
• [14]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.
• [15]Hazell L, Shakir S: Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006, 29:385-96.
• [16]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.
• [17]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.
• [18]Mundy A: Dispensing with the truth: the victims, the drug companies, and the dramatic story behind the battle over fen-phen. St. Martin’s Press, New York; 2001.
• [19]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. Health Council of Canada, Toronto; 2010.
• [20]Carpenter D: Reputation and power: organizational image and pharmaceutical regulation at the FDA. Princeton, Princeton University Press; 2010.