Deadly Medicines and Organised Crime

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

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  41 Escitalopram (Lexapro) for depression. Medical Letter. 2002; 44: 83–4.

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  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.

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  56 Hyltoft V. [Lundbeck partner in settlement about suicides]. Berlingske. 2011 Feb 8.

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  60 Harris G. Document details plan to promote costly drug. New York Times. 2009 Sept 1.

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  66 Stark J. McGorry aborts teen drug trial. Sydney Morning Herald. 2011 Aug 21.

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  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.