Здоровье без побочных эффектов

50. Liberati A., Traversa G., Moja L.P., et al. Feasibility and challenges of independent research on drugs: the Italian Medicines Agency (AIFA) experience. Eur J Clin Invest. 2010; 40: 69–86.

51. Light D.W., Lexchin J.R. Pharmaceutical research and development: what do we get for all that money? BMJ. 2012; 344: e4348.

52. Knowler W.C., Barrett-Connor E., Fowler S.E., et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002; 346: 393–403.

53. Ioannidis J.P., Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA. 2001; 285: 437–43.

54. Savulescu J., Chalmers I., Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ. 1996; 313: 1390–3.

55. Goldbeck-Wood S. Denmark takes a lead on research ethics. BMJ. 1998; 316: 1189.

56. Goldacre B. Bad Pharma. London: Fourth Estate; 2012.

57. Lundh A., Krogsbøll L.T., Gøtzsche P.C. Access to data in industry-sponsored trials. Lancet. 2011; 378: 1995–6.

58. Lundh A., Krogsbøll L.T., Gøtzsche P.C. Sponsors’ participation in conduct and reporting of industry trials: a descriptive study. Trials. 2012; 13: 146.

59. Heran B.S., Wong M.M.Y., Heran I.K., et al. Blood pressure lowering effi cacy of angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2008; 4: CD003823.

60. Directive 2010/84/EU of the European Parliament and of the Council. 2010 Dec 15.

61. Gøtzsche P.C., Liberati A., Luca P., et al. Beware of surrogate outcome measures. Int J Technol Ass Health Care. 1996; 12: 238–46.

62. Apolone G., Joppi R., Bertele V., et al. Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to fi nd a balance between different pressures. Br J Cancer. 2005; 93: 504–9.

63. Garattini S., Bertele V. Effi cacy, safety, and cost of new anticancer drugs. BMJ. 2002; 325: 269–71.

64. Machin D., Stenning S.P., Parmar M.K.B., et al. Thirty years of Medical Research Council randomized trials in solid tumours. Clin Oncol. 1997; 9: 100–14.

65. Soares H.P., Kumar A., Daniels S., et al. Evaluation of new treatments in radiation oncology: are they better than standard treatments? JAMA. 2005; 293: 970–8.

66. Kumar A., Soares H., Wells R., et al. Are experimental treatments for cancer in children superior to established treatments? Observational study of randomised controlled trials by the Children’s Oncology Group. BMJ. 2005; 331: 1295–8.

67. Avorn J. Powerful Medicines: the benefi ts, risks, and costs of prescription drugs. New York: Vintage Books; 2005.

68. Rochon P.A., Fortin P.R., Dear K.B., et al. Reporting of age data in clinical trials of arthritis. Deficiencies and solutions. Arch Intern Med. 1993; 153: 243–8.

69. Van Spall H.G., Toren A., Kiss A., et al. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA. 2007; 297: 1233–40.

70. Cerreta F., Eichler H.G., Rasi G. Drug policy for an aging population – the European Medicines Agency’s geriatric medicines strategy. N Engl J Med. 2012; 367: 1972–4.

71. World Medical Association. Ethical Principles for Medical Research Involving Human Subjects. 2008. Available online at: www.wma.net/en/30publications/10policies/b3/ (accessed 17 July 2013).

72. Whitaker R. Anatomy of an Epidemic. New York: Random House; 2010.

73. Strom B.L. How the US drug safety system should be changed. JAMA. 2006; 295: 2072–5.

74. Ray W.A., Stein C.M. Reform of drug regulation – beyond an independent drug-safety board. N Engl J Med. 2006; 354: 194–201.

75. Newman M. Bitter pills for drug companies. BMJ. 2010; 341: c5095.

76. Alsman S.W. [Hidden research led to wrong recommendations about happy pills]. Økonomisk Ugebrev. 2004 May 3.

77. Senate Republican Policy Committee. Legislative Notice No. 13. S. 1082 – The FDA Revitalization Act. Available online at: http://rpc.senate.gov/_fi les/L13S1082FDARevitalizationAct043007KP.pdf (accessed 30 October 2007).

78. Suntharalingam G., Perry M.R., Ward S., et al. Cytokine storm in a phase 1 trial of the anti-CD 28 monoclonal antibody TGN 1412. N Engl J Med. 2006; 355: 1018–28.