78. This is a fascinating and messy new area. The paper below gives a good summary of the importance of analysing full trial programmes, and the discrepancies found on Tamiflu between papers and Clinical Study Reports: Jefferson T, Doshi P, Thompson M, Heneghan C, Group CARI. Ensuring safe and effective drugs: who can do what it takes? BMJ. 2011 Jan 11;342(jan11 1):c7258-c7258.
79. This is all from: Jefferson T, Doshi P, Thompson M, Heneghan C, Group CARI. Ensuring safe and effective drugs: who can do what it takes? BMJ. 2011 Jan 11;342(jan11 1):c7258-c7258.
80. Tom Jefferson, Lecture on Tamiflu, BMJ Evidence 2011, London.
81. Tramer MR, Reynolds DJ, Moore RA, McQuay HJ. Impact of covert duplicate publication on meta-analysis: a case study. BMJ. 1997 Sep 13;315(7109):635-40.
82. Doshi P, Jefferson T, Del Mar C (2012) The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience. PLoS Med 9(4): e1001201. doi:10.1371/journal.pmed.1001201 http://bit.ly/HIbwqO
83. Cohen D (2009) Complications: tracking down the data on oseltamivir. BMJ 339: b5387.
84. If you’re interested in this story, the links to primary documents are all here: Diabetes drug ‘victory’ is really an ugly story about incompetence. Ben Goldacre, The Guardian. 2010 Jul 17 [cited 2012 May 2]; Available from: http://www.badscience.net/ 2010/07/pharmaco-epidemiology-would-be-fascinatingenougheven-if-society-didnt-manage-it-really-really-badly/
85. Nissen SE. Setting the record straight. JAMA. 2010 Mar 24; 303(12):1194-5
86. Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G. Open Clinical Trial Data for All? A View from Regulators. PLoS Med. 2012 Apr 10;9(4):e100i202.
87. This is a vast story, told well elsewhere. Start with Curfman GD, Morrissey S, Drazen JM. Expression of concern reaffirmed. N. Engl. J. Med. 2006 Mar 16;354(11):1193.
88. Opinion: Misleading Drug Trials. The Scientist [Internet]. [cited 2012 May 15]. Available from: http://thescientist. com/2012/05/14/opinion-misleading-drug-trials/
89. The Yale Open Data Archive project, or YODA, is one good example of how this might look in the future.
1. I recommend the classic medical student textbook ‘Rang and Dale’: Rang & Dale’s Pharmacology. 6th ed. Churchill Livingstone; 2007. But also this, on the regulatory process around early drug development: Friedhoff LT. New Drugs: An Insider’s Guide to the FDA’s New Drug Approval Process for Scientists, Investors and Patients. 1st ed. PSPG Publishing, 2009.
2. Elliott C, Abadie R. Exploiting a research underclass in phase 1 clinical trials. New England Tournal of Medicine. 2008;358(22):2316.
3. Cohen LP. To screen new drugs for safety, Lilly pays homeless alcoholics: it’s ‘quick cash’ to habitues of Indianapolis shelters; it vanishes quickly, too. Wall St J (East Ed). 1996 Nov 14;A1, A10.
4. Abadie R. The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects. 1st ed. Duke University Press, 2010.
5. Helms R, editor. Guinea Pig Zero: An Anthology of the Journal for Human Research Subjects. 1st ed. Garrett County Press; 2006.
6. Tucker T. Great Starvation Experiment: Ancel Keys and the Men Who Starved for Science. 1st University of Minnesota Press Ed. University of Minnesota Press; 2008.
7. Gorkin L, Schron EB, Handshaw K, Shea S, Kinney MR, Branyon M, et al. Clinical trial enrollers vs. nonenrollers: The Cardiac Arrhythmia Suppression Trial (CAST) Recruitment and Enrollment Assessment in Clinical Trials (REACT) project. Controlled Clinical Trials. 1996 Feb;17(1):46–59.
8. Sheppard VB, Cox LS, Kanamori MJ, Canar J, Rodriguez Y, Goodman M, et al. BRIEF REPORT: If You Build It, They Will Come. J Gen Intern Med. 2005 May;20(5):444-7.
9. ACRO CRO Market [Internet]. [cited 2012 Feb 11].Available from: http://www.acrohealth.org/cro-market1.html.
10. MacDonald T, Hawkey C, Ford I. Time to treat as independent. BMJ. 2010 Nov 30;341(nov30 2):c6837-c6837.
11. Kassirer T. On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health. Ch 8. 1st ed. Oxford University Press, USA; 2004.
12. Pharmaceutical CSO — Pharmaceutical Commercialization — Quintiles [Internet.] Available from: http://www.quintiles.com/ commercial-services/
13. DRUG TESTING GOES OFFSHORE August 8, 2005 [Internet]. [cited 2012 Feb 11]. Available from: http://money.cnn.com/ magazines/fortune/fortune_archive/200 5/08/08/8267653/index. htm
14. Thiers FA, Sinskey AJ, Berndt ER. Trends in the globalization of clinical trials. Nature Reviews Drug Discovery. 2008 Jan;7(1):13-4.
15. All of the issues around trials in developing countries are well covered in two books, Shah S. BODY HUNTERS, THE: Testing New Drugs on the World’s Poorest Patients. SCIE. THE NEW PRESS; 2007. And Petryna A. When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. 1st ed. Princeton University Press; 2009.
