Вся правда о лекарствах. Мировой заговор фармкомпаний

16. Ethical and Scientific Implications of the Globalization of Clinical Research Seth W. Glickman, M.D., M.B.A., John G. McHutchison, M.D., Eric D. Peterson, M.D., M.P.H., Charles B. Cairns, M.D., Robert A. Harrington, M.D., Robert M. Califf, M.D., and Kevin A. Schulman, M.D. N Engl J Med 2009; 360:816–823. February 19, 2009.

17. Bansal N. The opportunities and challenges in conducting clinical trials globally. Clinical Research and Regulatory Affairs. 2012 Feb 9;1–6.

18. Ethical and Scientific Implications of the Globalization of Clinical Research Seth W. Glickman, M.D., M.B.A., John G. McHutchison, M.D., Eric D. Peterson, M.D., M.P.H., Charles B. Cairns, M.D., Robert A. Harrington, M.D., Robert M. Califf, M.D., and Kevin A. Schulman, M.D. N Engl J Med 2009; 360:816–823. February 19, 2009

19. Hyder AA, Wali SA, Khan AN, Teoh NB, Kass NE, Dawson L. Ethical review of health research: a perspective from developing country researchers. J Med Eth’cs. 2004 Feb;30(1):68–72.

20. Zhang D, Yin P, Freemantle N, Jordan R, Zhong N, Cheng KK. An assessment of the quality of randomised controlled trials conducted in China. Trials. 2008;9:22.

21. FDA Requires Foreign Clinical Studies be in Accordance with Good Clinical Practice to Better Protect Human Subjects by W. Thomas Smith American Bar Association Health eSource October 2008 Volume 5 Number 2 [Internet]. [cited 2012 Feb 11]. Available from: http://www.americanbar.org/ newsletter/ publications/aba_health_esource_home/Volume5_0 2_smith. html

22. WikiLeaks cables: Pfizer ‘used dirty tricks to avoid clinical trial payout’ Business The Guardian [Internet]. [cited 2012 Feb 11]. Available from: http://www.guardian.co.uk/business/2010/ dec/09/wikileaks-cables-pfizer-nigeria

23. US embassy cable Monday 20 April 2009, 16:00, Abuja 000671 ‘Pfizer reaches preliminary agreement for $75m settlement’ [cited 2012 Feb 11]. Available from: http://www.guardian.co.uk/ world/us-embassy-cablesdocuments/203205

24. WikiLeaks cables: Pfizer ‘used dirty tricks to avoid clinical trial payout’ Business The Guardian [Internet]. [cited 2012 Feb 11]. Available from: http://www.guardian.co.uk/business/ 2010/ dec/09/wikileaks-cables-pfizer-nigeria

25. Jonathan Kimmelman, Charles Weijer, and Eric M Meslin, ‘Helsinki discords: FDA, ethics, and international drug trials,’ The Lancet 373, no. 9657 (January 3, 2009): 13–14.

26. Goodyear MDE, Lemmens T, Sprumont D, Tangwa G. Does the FDA have the authority to trump the Declaration of Helsinki? BMJ. 2009 Apr 21;338(apr21 1):b1559-b1559.

Глава 3. Плохой контроль

1. Royal College of Physicians, London UK. INNOVATING FOR HEALTH. Patients, physicians, the pharmaceutical industry and the NHS. February 2009. Report of a Working Party.

2. If you’re very confused about the European Medicines Agency, and the UK MHRA, and how they relate to each other, it’s fairly simple. The MHRA used to approve drugs, now the EMA do, but they farm out some of the local work to the old national regulators, especially monitoring and communication, as well as some of the approval stuff.

3. I recommend the work of John Abraham, collected here: (http://www.sussex.ac.uk/profiles/6

4. Owen BM, Braeutigam R. The Regulation Game: Strategic Use of the Administrative Process. Ballinger Pub Co; 1978. Via Abraham J. On the prohibition of conflicts of interest in pharmaceutical regulation: Precautionary limits and permissive challenges. A commentary on Sismondo (66:9, 2008, 1909-14) and O’Donovan and Lexchin. Social Science & Medicine. 2010 Mar;70(5):648-51.

5. http://www.alter-eu.org/sites/default/files/documents/lonngrendoc.pdf

6. http://www.alter-eu.org/sites/default/files/documents/lonngrendoc.pdf

7. http://www.alter-eu.org/fr/press-releases/2011/02/25/conflictof-interest-case-involving-ex-ema-director

8. http://www.corporateeurope.org/publications/block-revolvingdoor

9. Lurie, P., Almeida, C., Stine, N., Stine, A. R., & Wolfe, S. M. (2006). Financial conflict of interest disclosure and voting patterns at food and drug administration drug advisory committee meetings. JAMA, 295, 1921e1928.

10. If you’re interested in starting on this, the following are a good place to start: http://www.nytimes.com/2009/09/25/health/ policy/25knee.html?_r=1; http://www.nytimes.com/ 2005/02/25/ politics/25fda.html. And the work of the Project On Government Oversight is excellent, led by the researcher who worked on Senator Grassley’s reports into the pharmaceutical industry: http://www.pogo.org/ investigations/public-health/fda.html; http://pogoblog.typepad.com/pogo/2011/08/fdas-janetwoodcock-thesubstance-behind-her-nonsubstantivesubstantive — ties-to-industry.html

11. Light D, editor. The Risks of Prescription Drugs (A Columbia/ SSRC Book. Columbia University Press; 2010).

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