«Я согласен участвовать в этом клиническом испытании, которое, скорее всего, не имеет никакой научной ценности, но будет полезно для компании в рекламе препарата. Я также понимаю, что если результаты разочаруют компанию, ими могут манипулировать и исказить до такой степени, чтобы они были выгодны. И если и это также не удастся, то результаты могут быть похоронены, чтобы никто за пределами компании их не увидел. Наконец, я понимаю и принимаю, что если будет доказано, что препарат приносит слишком много вреда, то либо они вообще не будут опубликованы, либо вред будет называться как-то по-другому, чтобы не вызывать у пациентов подозрений, которые снизят продажи».
Ссылки
1. Boseley S. Scandal of scientists who take money for papers ghostwritten by drug companies.The Guardian. 2002 Feb 7.
2. Vandenbroucke J.P. Without new rules for industry-sponsored research, science will cease to exist. BMJ. 2005 Dec 14.
3. McHenry L. Biomedical research and corporate interests: a question of academic freedom. Mens Sana Monographs. 2008 Jan 1.
4. Brynner R., Stephens T. Dark Remedy: the impact of thalidomide and its revival as a vital medicine. New York: Perseus Publishing; 2001.
1
5. Avorn J. Powerful Medicines: the benefits, risks, and costs of prescription drugs. New York: Vintage ooks; 2005.
6. Medawar C., Hardon A. Medicines out of Control? Antidepressants and the conspiracy of goodwill. Netherlands: Aksant Academic Publishers; 2004.
7. Kassirer J.P. On the Take: how medicine’s complicity with big business can endanger your health. Oxford: Oxford University Press; 2005.
8. Wiviott S.D., Braunwald E., McCabe C.H., et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007; 357: 2001–15.
9. Home P.D., Pocock S.J., Beck-Nielsen H., et al. Rosiglitazone evaluated for cardiovascular outcomes – an interim analysis. N Engl J Med. 2007; 357: 28–38.
10. Wallentin L., Becker R.C., Budaj A., et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009; 361: 1045–57.
11. Serebruany V.L., Atar D. Viewpoint: Central adjudication of myocardial infarction in outcomedriven clinical trials – common patterns in TRITON, RECORD, and PLATO? Thromb Haemost. 2012; 108: 412–14.
12. Davidoff F., DeAngelis C.D., Drazen J.M., et al. Sponsorship, authorship, and accountability. JAMA. 2001; 286: 1232–4.
13. Nordic Medical Research Councils’ HIV Therapy Group. Double-blind dose-response study of zidovudine in AIDS and advanced HIV infection. BMJ. 1992; 304: 13–17.
14. Gerstoft J., Melander H., Bruun J.N., et al. Alternating treatment with didanosine and zidovudine versus either drug alone for the treatment of advanced HIV infection: the ALTER study. Scand J Infect Dis. 1997; 29: 121–8.
15. Gøtzsche P.C., Hróbjartsson A., Johansen H.K., et al. Constraints on publication rights in industry initiated clinical trials. JAMA. 2006; 295: 1645–6.
16. Bassler D., Briel M., Montori V.M., et al. Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA. 2010; 303:1180–7.
17. Schulman K.A., Seils D.M., Timbie J.W., et al. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med. 2002; 347: 1335–41.
18. Mello M.M., Clarridge B.R., Studdert D.M. Academic medical centers standards for clinical-trial agreements with industry. N Engl J Med. 2005; 352: 2202–10.
19. Meier B. Contracts keep drug research out of reach. New York Times. 2004 Nov 29.
20. Steinbrook R. Gag clauses in clinical-trial agreements. N Engl J Med. 2005; 352: 2160–2.
21. Bekelman J.E., Li Y., Gross C.P. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003; 289: 454–65.
22. Statistics from the EudraCT database. EMEA/363785/2005.
23. 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.
24. Department of Health and Human Services, Office of Inspector General. Recruiting Human Subjects: pressures in industry-sponsored clinical research. June 2000, OEI-01-97-00195 (accessed 18 February 2008).
25. Cuatrecasas P. Drug discovery in jeopardy. J Clin Invest. 2006; 116: 2837–42.
26. Werkö L. [It is always about the life] [Swedish]. Helsingborg: AB Boktryck; 2000.
27. Boseley S. Junket time in Munich for the medical profession – and it’s all on the drug fi rms. The Guardian. 2004 Oct 5.
28. Gagnon M.-A. The Nature of Capital in the Knowledge-Based Economy: the case of the global pharmaceutical industry [dissertation]. Toronto: York University; May 2009.
29. Angell M. The Truth about the Drug Companies: how they deceive us and what to do about it. New York: Random House; 2004.
30. Elliott C. The drug pushers. The Atlantic Monthly. 2006 April.
31. Marcovitch H. Editors, publishers, impact factors, and reprint income. PLoS Med. 2010; 7: e1000355.
32. Bodenheimer T. Uneasy alliance – clinical investigators and the pharmaceutical industry. N Engl J Med. 2000; 342: 1539–44.
33. Rennie D. When evidence isn’t: trials, drug companies and the FDA. J Law Policy. 2007 July: 991–1012.
34. Kesselheim A.S., Robertson C.T., Myers J.A., et al. A randomized study of how physicians interpret research funding disclosures. N Engl J Med. 2012; 367: 1119–27.
35. Drazen J.M. Believe the data. N Engl J Med. 2012; 367: 1152–3.
36. Sun X., Briel M., Busse J.W., et al. The infl uence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review. BMJ. 2011; 342: d1569.
37. Lenzer J. NIH secrets. The New Republic. 2006 Oct 10.
38. Bracken M.B., Shepard M.J., Collins W.F., et al. A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury. Results of the Second National Acute Spinal Cord Injury Study. N