Deadly Medicines and Organised Crime

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by Peter Gotzsche


  Let’s estimate how many people Lilly has killed with Zyprexa. In 2007, it was reported that more than 20 million people had taken Zyprexa.78 A meta-analysis of the randomised trials of olanzapine and similar drugs given to patients with Alzheimer’s disease or dementia showed that 3.5% died on drug and 2.3% on placebo (P = 0.02).79 Thus, for every 100 patients treated, there was one additional death on the drug. Elderly patients are often treated with several drugs and are more vulnerable to their harms, which means that the death rate is likely higher than in younger patients. However, the reviewed trials generally ran for only 10–12 weeks, and most patients in real life are treated for years. Further, drugs like Zyprexa are most used in the elderly, and as deaths are often underreported in trials, the true death rate is likely higher than shown in the meta-analysis. One death in a hundred therefore seems a reasonable estimate to use. I therefore estimate that 200 000 of the 20 million patients treated with Zyprexa have been killed because of the drug’s harms. What is particularly saddening is that many of these patients shouldn’t have been treated with Zyprexa.

  As Zyprexa is not the only drug, the death toll must be much higher than this. AstraZeneca silenced a trial that showed that quetiapine (Seroquel) led to high rates of treatment discontinuations and significant weight increases while the company at the same time presented data at European and US meetings that indicated that the drug helped psychotic patients lose weight.80 Speakers Slide Kit and at least one journal article stated that quetiapine didn’t increase body weight while internal data showed that 18% of the patients had a weight gain of at least 7%.77 AstraZeneca propagated other lies.77 It presented a meta-analysis of four trials showing that quetiapine had better effect than haloperidol, but internal documents released through litigation showed it was exactly the opposite: quetiapine was less effective than haloperidol.

  The bottom line of psychotropic drugs

  How come we have allowed drug companies to lie so much, commit habitual crime and kill hundreds of thousands of patients, and yet we do nothing? Why don’t we put those responsible in jail? Why are many people still against allowing citizens to get access to all the raw data from all clinical trials and why are they against scrapping the whole system and only allow publicly employed academics to test drugs in patients, independently of the drug industry?

  I know some excellent psychiatrists who help their patients a lot, e.g. David Healy uses watchful waiting before giving drugs to first-episode patients.21 I also know that some drugs can be helpful sometimes for some patients. And I am not ‘antipsychiatry’ in any way. But my studies in this area lead me to a very uncomfortable conclusion:

  Our citizens would be far better off if we removed all the psychotropic drugs from the market, as doctors are unable to handle them. It is inescapable that their availability creates more harm than good.

  References

  1 Keller MB, Ryan ND, 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 JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Safety Med. 2008; 20: 73–81.

  4 Jureidini JN, McHenry LB. Conflicted 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 SH. 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 TA. 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 HA, Brown WA. 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 CJ, 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 TP. 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 SA, Dunner DL, Dunbar GC. Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo. Eur Neuropsychopharmacol. 1995; 5: 5–13.

  33 GlaxoSmithKline. Briefing Document. Paroxetine adult suicidality analysis: major depressive disorder 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 DT. 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 KC, et al. Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials. BMJ. 2005; 330: 396.

  37 Menzies KB. 2006 PDAC Regarding the Results of FDA’s Ongoing Meta-Analysis of Suicidality Data from Adult Antidepressant Trials. FDA. 2006 Dec 1.

  38 Schelin EM. [Healthy skepticism is the best medicine]. Ugeskr Læger. 2010; 172: 3361.

  39 Lexchin J, Light DW. Commercial influence and the content of medical journ
als. BMJ. 2006; 332: 1444–7.

  40 Gorman JM, 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 LT. [A difficult 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 TA, et al. Escitalopram versus other antidepressive agents for depression. Cochrane Database Syst Rev. 2009; 2: CD006532.

  49 Turner EH, Matthews AM, Linardatos E, et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008; 358: 252–60.

  50 Gartlehner G, Hansen RA, Morgan LC, et al. Comparative benefits and harms of second-generation 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 VL. [Lundbeck needs to fight 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 SM, et al. National trends in the office-based 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 RA. Pharmacotherapy of first-episode schizophrenia. Lancet. 2008; 371: 1048–9.

  65 Kahn RS, Fleischhacker WW, Boter H, et al. Effectiveness of antipsychotic drugs in first-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 first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet. 2009; 373: 31–41.

  68 Safer DJ. Design and reporting modifications in industry-sponsored 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 SA. 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 GI, Parry PI. 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 LS, Dagerman KS, 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.

  19

  Intimidation, threats and violence to protect sales

  I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard.

  John le Carré, The Constant Gardener

  It takes great courage to become a whistle-blower. Healthcare is so corrupt that those who expose drug companies’ criminal acts become pariahs. They disturb the lucrative status quo where people around them benefit handsomely from industry money: colleagues and bosses, the hospital, the university, the specialist society, the medical association and some politicians.

  A whistle-blower may even have the whole state against him, as happened for Stanley Adams when he reported Roche’s vitamin cartel to the European Commission in 1973.1 Willi Schlieder, Director-General for Competition at the Commission, leaked Adams’ name to Roche and he ended up in a Swiss prison, charged – and later convicted – with crimes against the state by giving economic information to a foreign power. Roche seems to have orchestrated the police interrogations and when Adams’ wife was told he could face 20 years in prison, she committed suicide. Adams was treated as a spy, court proceedings were held in secret, and he wasn’t even allowed to attend his wife’s funeral. The Swiss courts were completely resistant to the argument that Adams had done nothing wrong because Switzerland had broken its free trade agreement with the EU, which specified that violations of free competition should be reported.

  It is only in the United States that whistle-blowers may get rewarded to a substantial degree that allows them not to worry – at least not financially – that they might never get a job again. However, whistle-blowers are not motivated by possible financial bounty, but by their conscience, e.g. ‘I didn’t want to be responsible for somebody dying.’2 Some companies have ethical guidelines urging people to report irregularities internally and sometimes the leadership is happy to get such information, as they might want to take action. But that’s the exception. All the companies I have studied engage deliberately in criminal activities, and in the United States, there is a log of nearly a thousand healthcare qui tam cases (in which whistle-blowers with direct knowledge of the alleged fraud initiate the litigation on behalf of the government), and the Justice Department has suggested that the problem may get worse.2

  It’s a pretty bad idea to tell a company about its crimes, just like it’s a bad idea to tell a gangster that you have observed his unlawful activities. Peter Rost, a global vice president of marketing for Pfizer turned whistle-blower, has explained that ‘Pharmacia’s lawyer clearly thought that anyone who tried to resolve potential criminal acts within the company and keep his job was a mental case.’3 Most whistle-blowers who have cont
acted the company have been subjected to various pressures and sometimes seriously threatened, e.g. ‘Even if they find something the company will throw you under the bus and prove that you were a loose cannon and the only person doing it.’2 The company violence also extends to other companies: ‘I was fired … Then I took a job. Then somehow [company name not revealed] called the job. Then I was fired.’

  There are many similarities to mob crimes. Those who threaten the income from the crimes are exposed to violence, the difference being that in the drug industry, the violence is not of a physical but psychological nature, which can be equally devastating. This violence includes intimidation, instigation of fear, threats of firing or legal proceedings, actual firing and litigation, unfounded accusations of scientific misconduct, and other attempts at defamation and destruction of research careers. The manoeuvres are often carried out by the industry’s lawyers,4,5,6,7,8,9,10,11,12,13,14,15,16 and private detectives may be involved.16,17

  It is highly stressful to become a whistle-blower and cases take 5 years, on average.2 Peter Rost has described how things went for 233 people who blew the whistle on fraud:3 90% were fired or demoted, 27% faced lawsuits, 26% had to seek psychiatric or physical care, 25% suffered alcohol abuse, 17% lost their homes, 15% got divorced, 10% attempted suicide and 8% went bankrupt. But in spite of all this, only 16% said that they wouldn’t blow the whistle again.

  Thalidomide

  Private detectives kept an eye on physicians who criticised thalidomide,17 and when a physician had found 14 cases of extremely rare birth defects related to the drug, Grünenthal threatened him with legal action and sent letters to about 70 000 German doctors declaring that thalidomide was a safe drug, although the company – in addition to the birth defects – had reports of about 2000 cases of serious and irreversible nerve damage they kept quiet about. Grünenthal harassed the alert doctor for the next 10 years. An FDA scientist that refused to approve thalidomide for the US market was also harassed and intimidated, not only by the company but also by her bosses at the FDA.

 

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