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12. Survey of FDA Scientists Shows They Feel Pressure to Exclude…: Oncology Times [Internet]. [cited 2012 May 6]. Available from: http://journals.lww.com/oncology-times/Fulltext/2006/08250/Survey_of_FDA_Scientists_Shows_T hey_ Feel_Pressure.8.aspx

13. USATODAY.com Survey: FDA scientists question safety [Internet]. [cited 2012 May 6]. Available from: http://www.usatoday.com/news/health/2004-12-16-fda-surveyusat_x.htm

14. European Journal of Clinical Pharmacology 2011 10.1007/ s00228-011-1052-1 Anything new in EU pharmacovigilance? Silvio Garattini and Vittorio Bertele’.

15. Goldberg NH, Schneeweiss S, Kowal MK, Gagne JJ. Availability of Comparative Efficacy Data at the Time of Drug Approval in the United States. JAMA: The Journal of the American Medical Association. 2011 May 4;305(17):1786-9.

16. Bertele’ V, Banzi R, Gluud C, Garattini S. EMA’s reflection on placebo does not reflect patients’ interests. European Journal of Clinical Pharmacology [Internet]. 2011 Dec 2 [cited 2012 Feb 13]; Epub ahead of print. Available from: http://www.springerlink.com/content/4j733734v35381jk/

17. Garattini S, Chalmers I. Patients and the public deserve big changes in evaluation of drugs. BMJ. 2009 Mar 31;338(mar313):b1025b1025.

18. Van Luijn JCF, Gribnau FWJ, Leufkens HGM. Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization. Br J Clin Pharmacol. 2007;63(2):159–162.

19. Stafford RS, Wagner TH, Lavori PW. New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling. N Engl J Med. 2009 Aug 12;NEJMp0906490.

20. Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991 Mar;324(12):781–788.

21. ALLHAT Collaborative Research Group. Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). JAMA. 2000 Apr;283(15):1967–1975.

22. Lenzer J. Spin doctors soft pedal data on antihypertensives. BMJ. 2003 Jan 18;326(7381):170.

23. Vilsboll T, Christensen M, Junker AE, Knop FK, Gluud LL. Effects of glucagon-like peptide-1 receptor agonists on weight loss: systematic review and meta-analyses of randomised controlled trials. BMJ. 2012 Jan 11;344(jan10 2):d7771-d7771.

24. Grimes DA, Schulz KF. Surrogate end points in clinical research: hazardous to your health. Obstet Gynecol 2005;105:1114-8.

25. This graph is from Chapter 7 of an excellent (though long and serious) history of the FDA: Carpenter D. Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Princeton University Press; 2010.

26. Mitka M. FDA Takes Slow Road Toward Withdrawal of Drug Approved With Fast-Track Process. JAMA. 2011 Mar 9;305(10):982-4.

27. Press Announcements > FDA Proposes Withdrawal of Low Blood Pressure Drug [Internet]. [cited 2012 May 7]. Available from: http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm222580.htm