Итог по психотропным лекарствам
Как получилось, что мы позволяем фармацевтическим компаниям настолько много лгать, совершать преступления и убивать сотни тысяч пациентов? Почему мы ничего не делаем? Почему бы не заключить виновных в тюрьму? Почему многие люди по-прежнему против публичного доступа ко всем необработанным данным всех клинических испытаний? Почему они против слома всей системы, против того, чтобы только ученые из общественных организаций тестировали лекарства, без вмешательства фармацевтической промышленности?
Я знаю нескольких отличных психиатров, которые здорово помогают своим пациентам, например, Дэвид Хили использует выжидательную тактику, прежде чем выписать лекарства пациентам с первым эпизодом21. Я также знаю, что некоторые лекарства полезны для некоторых пациентов. И я ни в коем случае не «против психиатрии». Но мои исследования в этой области привели меня к неутешительному выводу.
«Нашим гражданам было бы гораздо лучше, если бы все психотропные лекарства исчезли с рынка, так как врачи не в состоянии с ними справляться. Их наличие создает больше вреда, чем пользы, и это неоспоримо.»
Ссылки
1.Keller M. B., Ryan N. D., Strober M., et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2001; 40: 762–72.
2.Bass A. Side Effects – a prosecutor, a whistleblower, and a bestselling antidepressant on trial. Chapel Hill: Algonquin Books; 2008.
3.Jureidini J. N., McHenry L. B., Mansfield P. R. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Safety Med. 2008; 20: 73–81.
4.Jureidini J. N., McHenry L. B. Confl icted medical journals and the failure of trust. Accountability in Research. 2001; 18: 45–54.
5.More fraud from drug giant GlaxoSmithKline companies – court documents show. Child Health Safety. 2010 Dec 1.
6.Moynihan R., Cassels A. Selling Sickness: how the world’s biggest pharmaceutical companies are turning us all into patients. New York: Nation Books; 2005.
7.Boyce J. Disclosure of clinical trial data: why exemption 4 of the freedom of information act should be restored. Duke Law & Technology Review. 2005; 3.
8.Jurand S. H. Lawsuits over Antidepressants Claim the Drug is worse than the Disease. American Association for Justice. 2003 Mar 1. Available online at: www.thefreelibrary.com/_/print/ PrintArticle.aspx?id=99601757 (accessed 23 Dec 2012).
9.Healy D. Pharmageddon. Berkeley: University of California Press;
2012.
10.Brownlee S. Overtreated: why too much medicine is making us sicker and poorer. New York: Bloomsbury; 2007.
11.Kingston A. A national embarrassment. Maclean’s Magazine. 2012
Oct 17.
12.The creation of the Prozac myth. The Guardian. 2008 Feb 27.
13.Healy D. Let Them Eat Prozac. New York: New York University Press; 2004.
14.Furukawa T. A. All clinical trials must be reported in detail and made publicly available. Lancet. 2004; 329: 626.
15.Harris G. Merck says it will post the results of all drug trials. New York Times. 2004 Sept 6.
16.Lenzer J. Secret US report surfaces on antidepressants in children. BMJ. 2004; 329: 307.
17.Lenzer J. Crisis deepens at the US Food and Drug Administration. BMJ. 2004; 329: 1308.
18.Giles J. Did GSK trial data mask Paxil suicide risk? New Scientist. 2008 Feb 8.
19.Healy D. SSRIs and deliberate self-harm. Br J Psychiatry. 2002;
180:547.
20.Khan A., Warner H. A., Brown W. A. Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: an analysis of the Food and Drug Administration database. Arch Gen Psychiatry. 2000; 57: 311–17.
21.Power N., Lloyd K.. Response from Pfizer. Br J Psychiatry. 2002;
180:547–8.
22.Rockhold F., Metz A., Traber P. Response from GlaxoSmithKline. Br J Psychiatry. 2002; 180: 548.
23.Healy D. Did regulators fail over selective serotonin reuptake inhibitors? BMJ. 2006; 333: 92–5.
24.Healy D., Cattell D. Interface between authorship, industry and science in the domain of therapeutics. Br J Psychiatry. 2003; 183: 22–7.
25.Lenzer J. FDA to review ‘missing’ drug company documents. BMJ. 2005; 330: 7.
26.Boseley S. Scandal of scientists who take money for papers ghostwritten by drug companies. The Guardian. 2002 Feb 7.
27.Whittington C. J., Kendall T., Fonagy P., et al. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet. 2004; 363: 1341–5.
28.Seroxat/Paxil Adolescent Depression. Position piece on the phase III clinical studies. GlaxoSmithKline document. 1998 Oct.
29.Laughren T. P. Overview for December 13 Meeting of Psychopharmacologic Drugs Advisory Committee (PDAC). 2006 Nov 16. Available online at: www.fda.gov/ohrms/dockets/ac/06/ briefing/2006- 4272b1-01-FDA.pdf (accessed 22 October 2012).
30.Internal Eli Lilly memo. Bad Homburg. 1984 May 25.
31. Eli Lilly memo. Suicide Report for BGA. Bad Homburg. 1990 Aug
3.
32.Montgomery S. A., Dunner D. L., Dunbar G. C. Reduction of suicidal thoughts with paroxetine incomparison with reference antidepressants and placebo. Eur Neuropsychopharmacol. 1995; 5: 5–13.
33.GlaxoSmithKline. Briefi ng Document. Paroxetine adult suicidality analysis: major depressivedisorder and non-major depressive disorder. 2006 April 5.
34.Gunnell D., Saperia J., Ashby D. Selective serotonin reuptake inhibitors (SSRIs) and suicide in adults: meta-analysis of drug company data from placebo controlled, randomised controlled trials submitted to the MHRA’s safety review. BMJ. 2005; 330: 385.
35.Healy D. T. Risk of suicide. BMJ. 2005 Feb 18. Available online at: www.bmj.com/content/330/7488/385?tab=responses (accessed 18 December 2012).
36.Fergusson D., Doucette S., Glass K. C., et al. Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials. BMJ. 2005; 330: 396.
37.Menzies K. B. 2006 PDAC Regarding the Results of FDA’s Ongoing Meta-analysis of Suicidality Data from Adult Antidepressant Trials. FDA. 2006 Dec 1.
38.Schelin E. M. [Healthy skepticism is the best medicine]. Ugeskr Læger. 2010; 172: 3361.
39.Lexchin J., Light D. W. Commercial influence and the content of medical journals. BMJ. 2006; 332: 1444–7.
40.Gorman J. M., Korotzer A., Su G. Efficacy comparison of escitalopram and citalopram in the treatment of major depressive disorder: pooled analysis of placebo-controlled trials. CNS Spectr. 2002; 7(4 Suppl. 1): 40–4.
41.Escitalopram (Lexapro) for depression. Medical Letter. 2002; 44:
83–4.
42.Melander H., Ahlqvist-Rastad J., Meijer G., et al. Evidence b(i)ased medicine – selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ. 2003; 326: 1171– 3.
43.Carlsen L. T. [A diffi cult balance]. Tænk + Test. 2003; 32: 30–3.
44.Lindberg M. [Interesting regard for exports]. Dagens Medicin. 2002
Nov 29.
45.[The Danish Drug Agency gives Lundbeck hindwind]. Politiken. 2004 Sept 13.
46.[Treatment with antidepressants]. Danish Institute for Rational Drug Therapy. 2004 Sept 10.
47.Dyer O. Lundbeck broke advertising rules. BMJ. 2003; 326: 1004.
48.Cipriani A., Santilli C., Furukawa T. A., et al. Escitalopram versus other antidepressive agents for depression. Cochrane Database Syst Rev. 2009; 2: CD006532.
49.Turner E. H., Matthews A. M., Linardatos E., et al. Selective publication of antidepressant trials and its infl uence on apparent efficacy. N Engl J Med. 2008; 358: 252–60.
50.Gartlehner G., Hansen R. A., Morgan L. C., et al. Comparative benefi ts and harms of secondgeneration antidepressants for treating major depressive disorder: an updated meta-analysis. Ann Intern Med. 2011; 155: 772–85.
51.Dyer O. Lundbeck broke advertising rules. BMJ. 2003; 326: 1004.
52.Masculine. Available online at: www.sprunk-jansen.com/da (accessed 2012 October 28).
53.Svansø V. L. [Lundbeck needs to fi ght for the company’s image]. Berlingske. 2011 May 14.
54.Petersen M. Our Daily Meds. New York: Sarah Crichton Books;
2008.
55.US Department of Justice. Drug Maker Forest Pleads Guilty; to pay more than $313 million to resolve criminal charges and False Claims Act allegations. 2010 Sept 15.
56.Hyltoft V. [Lundbeck partner in settlement about suicides]. Berlingske. 2011 Feb 8.
57.Meier B., Carey B. Drug maker is accused of fraud. New York Times. 2009 Feb 25.
58.Edwards J. Suit vs. Forest Labs names execs linked to alleged lies about Lexapro, Celexa. CBS News, Moneywatch. 2009 Feb 26.
59.Meier B. A medical journal quandary: how to report on drug trials. New York Times. 2004 June 21.
60.Harris G. Document details plan to promote costly drug. New York Times. 2009 Sept 1.
61.US Senate, Committee on Finance. Letter about Lexapro documents. 2009 Aug 12. Available online at: www.nytimes.com/packages/pdf/politics/20090831MEDICARE/20090831_ MEDICARE. pdf (accessed 2011).
62.Olfson M., Blanco C., Liu S. M., et al. National trends in the officebased treatment of children, adolescents, and adults with antipsychotics. Arch Gen Psychiatry. 2012; Aug 6: 1–10.
63.Tyrer P., Kendall T. The spurious advance of antipsychotic drug therapy. Lancet. 2009; 373: 4–5.
64.Rosenheck R. A. Pharmacotherapy of fi rst-episode schizophrenia. Lancet. 2008; 371: 1048–9.
65.Kahn R. S., Fleischhacker W. W., Boter H., et al. Effectiveness of antipsychotic drugs in fi rst-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial. Lancet. 2008; 371: 1085–97.
66.Stark J. McGorry aborts teen drug trial. Sydney Morning Herald. 2011 Aug 21.
67.Leucht S., Corves C., Arbter D., et al. Second-generation versus fi rst-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet. 2009; 373: 31–41.
68.68 Safer D. J. Design and reporting modifi cations in industrysponsored comparative psychopharmacology trials. J Nerv Ment Dis. 2002;
190:583–92.
69.Thornley B., Adams C. Content and quality of 2000 controlled trials in schizophrenia over 50 years. BMJ. 1998; 317: 1181–4.
70.Pfizer memorandum. 1989 April 26.
71.Duggan L., Fenton M., Rathbone J., et al. Olanzapine for schizophrenia. Cochrane Database Syst Rev. 2005; 2: CD001359.
72.Lenzer J. Drug company tries to suppress internal memos. BMJ. 2007; 334: 59.
73.Geddes J., Freemantle N., Harrison P., et al. Atypical antipsychotics in the treatment of schizophrenia: systematic overview and meta-regression analysis. BMJ. 2000; 321: 1371–6.
74.Larsen N.-E. [New medicine has considerable adverse effects]. Dagens Medicin. 2001 Sept 27.
75.Sheller S. A. The Largest Pharma Fraud Whistleblower Case in US history totaling $1.4 billion. Press release. 2009 Jan 15. Available online at:
www.reuters.com/article/2009/01/15/idUS182128+15-Jan- 2009+PRN20090115 (accessed 17 July 2013).
76.Berenson A. Eli Lilly said to play down risk of top pill. New York Times. 2006 Dec 17.
77.Spielmans G. I., Parry P. I. From evidence-based medicine to marketing-based medicine: evidence from internal industry documents. Bioethical Inquiry. 2010. DOI 10.1007/s11673-010-9208-8.
78.Dyer O. Lilly investigated in US over the marketing of olanzapine. BMJ. 2007; 334: 171.
79.Schneider L. S., Dagerman K. S., Insel P. Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials. JAMA. 2005; 294: 1934–43.
80.McGauran N., Wieseler B., Kreis J., et al. Reporting bias in medical research – a narrative review. Trials. 2010; 11: 37.