39. Pfizer memoranda, 24 and 26 April 1989.

40. Grill M. Kranke Geschäfte: wie die Pharmaindustrie uns manipuliert. Hamburg: Rowohlt Verlag; 2007.

41. Relman A.S., Angell M. America’s other drug problem: how the drug industry distorts medicine and politics. The New Republic. 2002 Dec 16: 27–41.

42. Ismail M. Drug Lobby Second to None: how the pharmaceutical industry gets its way in Washington. The Center for Public Integrity. 2005 July 7.

43. Bass A. Side Effects – a prosecutor, a whistleblower, and a bestselling antidepressant on trial. Chapel Hill: Algonquin Books; 2008.

44. Gøtzsche P.C., Jørgensen A.W. Opening up data at the European Medicines Agency. BMJ. 2011; 342: d2686.

45. Anonymous. FDA more transparent than EMEA. Prescrire International. 2002; 11: 98.

46. Garattini S., Bertele V. How can we regulate medicines better? BMJ. 2007; 335: 803–5.

47. Kranish M. Drug industry costs doctor top FDA post. Boston Globe. 2002 May 27.

48. Goozner M. The $800 Million Pill: the truth behind the cost of new drugs. Berkeley: University of California Press; 2005.

49. McClellan M.B. Speech before First International Colloquium on Generic Medicine. Available online at: www.fda.gov/oc/speeches/2003/genericdrug0925.html (accessed 18 February 2008).

50. Carpenter D., Zucker E.J., Avorn J. Drug-review deadlines and safety problems. N Engl J Med. 2008; 358: 1354–61.

51. Carpenter D. Drug-review deadlines and safety problems (authors’ reply). N Engl J Med. 2008; 359: 96–8.

52. Moore T.J., Cohen M.R., Furberg C.D. Serious adverse drug events reported to the Food and Drug Administration, 1998–2005. Arch Intern Med. 2007; 167: 1752–9.

53. Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Arch Intern Med. 2012 Oct 8: 1–2.

54. Avorn J. Paying for drug approvals – who’s using whom? N Engl J Med. 2007; 356: 1697–700.

55. Psaty B.M., Korn D. Congress responds to the IOM drug safety report – in full. JAMA. 2007; 298: 2185–7.

56. Harris G., Halbfinger D.M. FDA reveals it fell to a push by lawmakers. New York Times. 2009 Sept 25.

57. Dhruva S.S., Bero L.A., Redberg R.F. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009; 302: 2679–85.

58. Van Brabandt H., Neyt M., Hulstaert F. Transcatheter aortic valve implantation (TAVI): risky and costly. BMJ. 2012; 345: e4710.

59. Collier J. Big pharma and the UK government. Lancet. 2006; 367: 97–8.

60. Lee K., Bacchetti P., Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med. 2008; 5: e191.

61. European Commission. Strategy to Better Protect Public Health by Strengthening and Rationalising EU Pharmacovigilance. 2007 Dec 5.

62. HAI Europe. Pharmacovigilance in Europe and Patient Safety: no to deregulation. Press release. 2008 Feb 1.

63. Larsen H., Nyborg S. [The drug industry asks for control]. Politiken. 2006 Mar 5.

64. [Committee on Scientifi c Dishonesty tamed]. Ugeskr Læger. 2005; 167: 3476–7.

65. Greene J.A., Choudhry N.K., Kesselheim A.S., et al. Changes in direct-to-consumer pharmaceutical advertising following shifts from prescription-only to over-the-counter status. JAMA. 2012; 308: 973–5.

66. Welch H.G. Should I be Tested for Cancer? Maybe not and here’s why. Berkeley: University of California Press; 2004.

67. Welch H.G., Schwartz L., Woloshin S. Overdiagnosed: making people sick in the pursuit of health. Boston, MA: Beacon Press; 2011.

68. Andersen N.V. [Drug giant uses American pressure in Danish drug case]. Politiken. 2004 Aug 31.

69. Amendment to the Federal Food, Drug and Cosmetic Act. Washington, DC: 4 Jan, 2007. Available online at: www.fda.gov/oc/initiatives/HR3580.pdf (accessed 8 July 2008).

70. Moore T.J., Furberg C.D. The safety risks of innovation: the FDA’s Expedited Drug Development Pathway. JAMA. 2012; 308: 869–70.

71. Jefferson T., Jones M.A., Doshi P., et al. Neuraminidase inhibitors for preventing and treating infl uenza in healthy adults and children. Cochrane Database Syst Rev. 2012; 1: CD008965.

72. Meier B. Contracts keep drug research out of reach. New York Times. 2004 Nov 29.

73. Lurie P., Wolfe S.M. Misleading data analyses in salmeterol (SMART) study. Lancet. 2005; 366: 1261–2.

74. Rickard K.A. Misleading data analyses in salmeterol (SMART) study – GlaxoSmithKline’s reply. Lancet. 2005; 366: 1262.

75. Castle W., Fuller R., Hall J., et al. Serevent nationwide surveillance study: comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment. BMJ. 1993; 306: 1034–7.

76. Salpeter S.R., Buckley N.S., Ormiston T.M., et al. Meta-analysis: effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths. Ann Intern Med. 2006; 144: 904–12.

77. FDA Drug Safety Communication: new safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs). 2010 Feb 18. Available online at: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ ucm200776.htm (accessed 8 October 2012).

78. Nelson H.S., Weiss S.T., Bleecker E.R., et al. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006; 129: 15–26.

79. Curfman G.D., Morrissey S., Drazen J.M. Products at risk. N Engl J Med. 2010; 363: 1763.

80. Harris G. Pfi zer says internal studies show no Celebrex risks. New York Times. 2005 Feb 5.

81. Caldwell B., Aldington S., Weatherall M., et al. Risk of cardiovascular events and celecoxib: a systematic review and meta-analysis. J R Soc Med. 2006; 99: 132–40.

82. Sherman M., Marchione M. Pfizer: Celebrex raises heart attack risk. ABC News. 2004 Dec 17.

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

84. Avorn J. Dangerous deception – hiding the evidence of adverse drug effects. N Engl J Med. 2006; 355: 2169–71.

85. Petersen M. Our Daily Meds. New York: Sarah Crichton Books; 2008.