Deadly Medicines and Organised Crime

by Peter Gotzsche

  Under a heading called ‘The facts’, the guideline starts with two untrue statements: ‘Opportunities may be missed or even rejected because of misconceptions stemming from historical practices that are no longer acceptable, or the actions of a few individuals that are not typical of the working relationship between healthcare professionals and the industry.’

  These practices are not historical and they are not atypical. Further, the guideline is said to ‘Reflect the industry’s determination to ensure that relationships with healthcare professionals are based on integrity, honesty, knowledge, appropriate behaviours, transparency and trust.’ We are also told that ‘All trials are subject to rigorous scrutiny … the results of controlled clinical trials are made available in the public domain … ABPI Code of Practice requires disclosure of details of clinical trials.’ The reality is that we never see details of clinical trials, loads of results are buried and effectively sealed in company archives as effectively as if it were nuclear waste, and the trials are never subjected to rigorous scrutiny, as the ethics committees don’t do it and don’t have the expertise to do it.

  The guidance’s claims that ‘Undertaken appropriately, working with industry will not harm objectivity of clinical decision-making’ and that regulations ensure that professional and ethical standards are upheld – are at odds with everything we know about the subject. We are also told that ‘Pharmaceutical industry investment is the source of most of the scientific breakthroughs and innovations in medicines … typically costs £550 million to do all the work necessary before a medicine can be licensed for use.’

  I have never seen so much bullshit and lies crammed in one place before. Partnerships can occasionally be beneficial for both sides, but, overall, it’s immensely harmful for patients that the establishment embraces the industry’s ways with its drugs. The idea that public health and the drug industry have a common agenda is PR fiction, and the UK healthcare system is already at an ethical bottom level. In 2012, the UK government announced that general practitioners will be expected to work with drug companies to work out how to treat their patients.28 The ABPI’s guide, supported by the Department of Health, says that ‘Popular areas for joint working you may wish to consider include identification of undiagnosed patients, reviewing uncontrolled patients, improving patient adherence to medicines and treatment pathway redesign.’ This includes inviting salespersons to go through the GPs’ patient lists and pick out those they think should receive the company’s drugs.

  The British must live on another planet than I do. They should read Chapter 12 about Neurotin for everything where salespeople also sat with doctors and their patients and suggested what they should do. What we should do is the exact opposite. Identify overdiagnosed and overtreated patients, take patients off most or all of their drugs, and teach them that a life without drugs is possible for most of us.

  In his book Bad Pharma, Ben Goldacre writes that the silverbacks – the great and good of British medicine – know full well what the problems with all this are but have decided to be unconcerned, thereby, like the regulators, they actively conspire in the secrecy about what drug companies are really doing to public health.28 It is hard to imagine a worse betrayal than this. If I were a GP in the UK, I would get another job or leave the country.

  Also in 2012, The International Diabetes Federation, an umbrella organisation of more than 200 diabetes associations in over 160 countries, started a partnership with Nestlé, which intensely markets energy-dense confectionery and sugar-sweetened beverages.29 Nestlé has caused many deaths in the developing world because of its unethical promotion of infant formula, which needs addition of clean water that is often not available. Perhaps our lung associations should follow the fashion and partner with the tobacco industry? Why not? Politicians might acclaim it.

  Myth 7: Drug trials are done to improve the treatment of patients

  PR material and collaborative agreements between doctors’ associations and industry associations propagate this myth.30 However, no matter what the drug industry says about working for patients, they have no more responsibility to oversee the public’s health than the fast-food industry has to oversee the public’s diet.31 And they are not genuinely interested in it. Either a study is designed to maximise sales or it is designed to determine the best way to prevent or treat a particular health problem.

  When patients are recruited for trials, a benefit of participation that is almost always described in the consent document is that the research participant will contribute to scientific knowledge, which will in turn contribute positively to the care of other patients. However, as I explained in Chapter 5, this social contract with patients is broken. Trials are done for marketing purposes, and unwelcome results are kept secret or are distorted before they get published, although their availability would have improved the treatment of patients.

  Another myth is that the industry would have no point in cheating, as it would always be detected and influence sales negatively. One of the persons who told me this conducted clinical trials for a Danish drug company. He was convinced he was right and was proud of his job. Good for him, but he wasn’t the one who analysed the data and made decisions about how they should be interpreted and whether they were so harmful for profits that they would never see the light of day outside the company. As I have documented in this book, the truth is that companies cheat a lot because it can rarely be detected without having access to the raw data and because it pays off.

  Myth 8: We need many drugs of the same type because patients vary in their response

  I have heard this argument countless times from doctors who have listened to the pep talks of drug salespeople without reflecting much on whether it was true or not. In rare cases, it could be true, but I have not seen convincing data that confirm it. One of the trials that purported to show that patients reacted differently was a crossover trial where patients with rheumatoid arthritis tried four different drugs and told the investigators which period they preferred.32 This doesn’t prove anything, as the severity of the pain fluctuates. To be sure that the preferences aren’t just random noise, we would need to expose the same patients to the same drugs more than once.

  Myth 9: Don’t use generic drugs, as their potency varies

  Pfizer once claimed that its own tests of generic products that contained the same active substance as Pfizer’s drug against dizziness had shown that 10 of 17 generic products failed to meet potency standards.6 Contrast this with the fact that drug agencies ensure that generic products are bioequivalent with the original drug by requiring comparative studies in human volunteers that measure the concentrations of the active substance in the blood.

  Many doctors believe in this nonsense, which has been consistently rejected whenever researchers without conflicts of interest did the bioavailability studies.

  Myth 10: The industry pays for continuing medical education because the public purse won’t

  If true, this would be an act of immense generosity, as it is expensive and affects most doctors. As I have explained in Chapter 8, it is so clear what this is all about that not even the drug industry’s representative bodies deny it but admit that this is how they do business. Three of the largest US advertising agencies handling pharmaceutical accounts invest in contract research organisations and prepare ‘educational’ packages for the drug industry.3

  As Marcia Angell said in an interview, the companies perpetrate a gigantic fiction that they somehow are not only in the business of selling drugs, but are also in the medical education business.17 Their investors expect them to make as high profits as they possibly can by selling drugs. But they have managed to make a lot of people believe that they are also somehow educating them. That can’t be. It’s as though you look to beer companies to educate you about alcoholism. There is also the conflict of interest. Drug companies might ‘educate’ doctors about drugs as long as they’re talking about the benefits, but are they going to say, ‘Our drug isn’t really very good; t
he other company makes a better drug?’ No. It doesn’t happen.

  References

  1 Angell M. The Truth about the Drug Companies: how they deceive us and what to do about it. New York: Random House; 2004.

  2 Federal Trade Commission. Generic Drug Entry Prior to Patent Expiration: an FTC study. 2002, July. Available online at: www.ftc.gov/os/2002/07/genericdrugstudy.pdf (accessed 1 November 2007).

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

  4 Braithwaite J. Corporate Crime in the Pharmaceutical Industry. London: Routledge & Kegan Paul; 1984.

  5 Adams S. Roche versus Adams. London: J. Cape; 1984.

  6 Clinard MB, Yeager PC. Corporate Crime. New Brunswick: Transaction Publishers; 2006.

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

  8 Nelson R. Debate over ritonavir price increase gains momentum. Lancet. 2004; 363: 1369.

  9 Brody H. Hooked: ethics, the medical profession, and the pharmaceutical industry. Lanham: Rowman & Littlefield; 2008.

  10 Hemmingsen MA. [Antidepressant medicine increases by 1200 percent in three months]. Dagens Medicin. 2010 Sept 17.

  11 Andersen L. [Drug prices will be trenched]. Jyllandsposten. 2007 March 30.

  12 Dilling S. [Price for cholesterol lowering drug explodes]. Politiken. 2007 March 28.

  13 Svansø VL. [Lundbeck purchase costs a court case]. Berlingske. 2009 Feb 21.

  14 Drug company granted monopoly – price of drug increases 15000%. Pioneer Press. 2011 March 14.

  15 Messori A, Cicchetti A, Patregani L. Relating price determination to disease prevalence. BMJ. 2010; 341: 417–18.

  16 Cuatrecasas P. Drug discovery in jeopardy. J Clin Invest. 2006; 116: 2837–42.

  17 PBS. The Other Drug War. Interview with Marcia Angell. 2002 Nov 26. Available online at: www.pbs.org/wgbh/pages/frontline/shows/other/interviews/angell.html (accessed 4 April 2005).

  18 Steenberger A, Larsen K, Bundgaard B. [The minister of health wishes to discuss prioritisation with the regions]. Ugeskr Læger. 2011; 173: 472.

  19 Svansø VL, Hyltoft V. [The regions at war with the drug industry]. Berlingske. 2011 Feb 3.

  20 Quotations. Ugeskr Læger. 2010; 172: 1568.

  21 Svansø VL, Hyltoft V. [Drug industry under pressure]. Berlingske. 2011 Feb 3.

  22 Cumming J, Mays N, Daubé J. How New Zealand has contained expenditure on drugs. BMJ. 2010; 340: 1224–7.

  23 Mintzberg H. Patent nonsense: evidence tells of an industry out of social control. CMAJ. 2006; 175: 374.

  24 Stevens AJ, Jensen JJ, Wyller K, et al. The role of public-sector research in the discovery of drugs and vaccines. N Engl J Med. 2011; 364: 535–41.

  25 Light DW, Lexchin JR. Pharmaceutical research and development: what do we get for all that money? BMJ. 2012; 344: e4348.

  26 The Association of the British Pharmaceutical Industry. Guidance on Collaboration between Healthcare Professionals and the Pharmaceutical Industry. 2012 March 29. Available online at: www.abpi.org.uk/our-work/library/guidelines/Pages/collaboration-guidance.aspx (accessed 27 December 2012).

  27 Braillon A, Bewley S, Herxheimer A, et al. Marketing versus evidence-based medicine. Lancet. 2012; 380: 340.

  28 Goldacre B. Bad Pharma. London: Fourth Estate; 2012.

  29 Beran D, Capewell S, de Courten M, et al. The International Diabetes Federation: losing its credibility by partnering with Nestlé? Lancet. 2012; 380: 805.

  30 Danish Association of the Pharmaceutical Industry. [Revised collaborative agreement between the Medical Association and the Danish Association of the Pharmaceutical Industry about clinical trials and non-intervention studies]. 2010 June 1.

  31 Abramson J. Overdo$ed America: the broken promise of American medicine. New York: HarperCollins; 2004.

  32 Huskisson EC, Woolf DL, Balme HW, et al. Four new anti-inflammatory drugs: responses and variations. Br Med J. 1976; 1: 1048–9.

  21

  General system failure calls for a revolution

  I find it hard to imagine that a system this corrupt can be a good thing, or that it is worth the vast amounts of money spent on it.

  Marcia Angell, former editor, New England Journal of Medicine1

  If an improvement in human health was our primary aim, some of the billions currently invested in expensive drugs to lower cholesterol of the worried well might be far more efficiently spent on enhanced campaigns to reduce smoking, increase physical activity, and improve diet.

  Moynihan and Cassels, in Selling Sickness2

  Our drugs kill us

  Our drugs kill us on a horrific scale. This is unequivocal proof that we have created a system that is out of control. Good data are available,3,4,5 and what I have made out of the various studies is that around 100 000 people die each year in the United States because of the drugs they take even though they take them correctly. Another 100 000 die because of errors, such as too high dose or use of a drug despite contraindications. A carefully done Norwegian study found that 9% of those who died in hospital died directly because of the drugs they were given, and another 9% indirectly.6 Since about one-third of deaths occur in hospitals, these percentages also correspond to about 200 000 Americans dying every year. The European Commission has estimated that adverse reactions kill about 200 000 EU citizens annually (at a cost of €79 billion),7 which is somewhat less than the two other estimates, as there are about 60% more people in the EU than in the United States. In 2010, heart disease killed 600 000 Americans, cancer 575 000, and chronic lower respiratory disease came third with 140 000 deaths.8 This means that in the United States and Europe:

  drugs are the third leading cause of death after heart disease and cancer.

  The true number of drug deaths is likely higher. In hospital records and coroners’ reports, deaths linked to prescription drugs are often considered to be from natural or unknown causes, as they may be impossible to trace. For example, many drugs cause cardiac arrhythmia, which is a major cause of death in people treated with antipsychotic drugs. In previous chapters, I have estimated drug deaths in relation to some particular drugs, not in any way systematically selected, but the data support the finding that drugs are a major killer:

  The use of inferior drugs for hypertension is estimated to have caused heart failure in 40 000 patients in the United States

  At the peak of their use, anti-arrhythmic drugs were likely causing about 50 000 deaths every year in the United States

  By 2004, rofecoxib had likely caused about 120 000 deaths worldwide because of thrombosis (p. 161)

  By 2004, celecoxib had likely caused about 75 000 deaths worldwide because of thrombosis

  NSAIDs likely causes about 20 000 deaths every year in the United States because of ulcer complications (p. 169)

  By 2007, olanzapine had likely killed about 200 000 people worldwide.

  In addition to all the deaths, millions of people experience serious, disabling drug injuries every year.9 It is always difficult to separate causes of death, as several causes may contribute. Tobacco results in many deaths from heart disease and cancer, and if we look at tobacco as a separate cause, it comes up to about 440 000 deaths each year in the United States.10 Thus, the number of drug deaths is roughly half of the number of tobacco deaths.

  The main reasons for the deaths are far too permissive drug regulation, overmedicalisation, polypharmacy, too little knowledge about the harms of drugs, and thousands of warnings that no doctor can possibly master. Human errors abound in a system that is far too complicated for the human brain to handle. Imagine if airline pilots had thousands of little buttons in the cockpit at their disposal and that, furthermore, these buttons interacted in unpredictable ways if several were switched on simultaneously, analogous to a patient who is on several drugs.

  What we need are radical changes. Most importantly, we need to demedicalise
our societies with the same reasoning that no one would dare to fly if the pilots’ actions had unpredictable effects. Every one of us can contribute to demedicalisation by being conservative about drugs. If you don’t absolutely need a drug, then don’t take it. We rarely need drugs. We are rarely in situations where a drug may save our life, or where a drug could make a major difference to our lives. Most of the time, the drugs don’t have any positive effect on us (see Chapter 4). A systematic review showed that stopping antihypertensive and psychotropic drugs in the elderly generally went very well, and for the latter group of drugs it resulted in fewer falls and improved cognition.11

  Selling drugs to healthy people who don’t need them is how the industry has boosted its profits. It’s like a cancer that has grown uncontrollably in society for many years now, which is nourished to a large extent by organised crime, scientific dishonesty, outrageous lies and bribery. We need to stop this.12

  Journal editors know where the evil comes from. According to Drummond Rennie, deputy editor of JAMA, ‘The pharmaceutical companies, by their arrogant behaviour and their naked disregard for the well-being of the public, have lost our trust. The FDA, by spinelessly knuckling under to every whim of the drug companies, has thrown away its high reputation, and in so doing, forfeited our trust.’13 Rennie has also noted that, as soon as they left their posts as editor-in-chief of the New England Journal of Medicine and BMJ, Jerome Kassirer, Marcia Angell and Richard Smith each bemoaned the appalling influence of drug company money on the morals and practices of their profession in a book.1,14,15