Deadly Medicines and Organised Crime
Page 1
Deadly Medicines and Organised Crime
How big pharma has corrupted healthcare
PETER C GØTZSCHE
Forewords by
Richard Smith
former editor-in-chief, BMJ
Drummond Rennie
deputy editor, JAMA
Radcliffe Publishing
London • New York
Radcliffe Publishing Ltd
St Mark’s House
Shepherdess Walk
London N1 7LH
United Kingdom
www.radcliffehealth.com
_____________________________________
© 2013 Peter C Gøtzsche
Peter C Gøtzsche has asserted his right under the Copyright, Designs and Patents Act 1988 to be identified as the author of this work.
The author and publisher shall have no liability or responsibility to any person or entity regarding any loss or damage incurred, or alleged to have incurred, directly or indirectly, by the information contained in this book.
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the copyright owner.
British Library Cataloguing in Publication Data
A catalogue record for this book is available from the British Library.
ISBN 978-190891-112-4
Digital conversion by Vivianne Douglas www.darkriver.co.nz
Contents
Foreword by Richard Smith
Foreword by Drummond Rennie
About the author
1 Introduction
2 Confessions from an insider
Asthma deaths were caused by asthma inhalers
Shady marketing and research
3 Organised crime, the business model of big pharma
Hoffman-La Roche, the biggest drug pusher
Hall of Shame for big pharma
The crimes are repetitive
It’s organised crime
4 Very few patients benefit from the drugs they take
5 Clinical trials, a broken social contract with patients
6 Conflicts of interest at medical journals
7 The corruptive influence of easy money
8 What do thousands of doctors on industry payroll do?
Seeding trials
Rent a key opinion leader to ‘give advice’
Rent a key opinion leader to ‘educate’
9 Hard sell
Clinical trials are marketing in disguise
Ghostwriting
The marketing machine
Hard sell ad nauseam
Highly expensive drugs
Excesses in hypertension
Patient organisations
NovoSeven for bleeding soldiers
10 Impotent drug regulation
Conflicts of interest at drug agencies
Corruption at drug agencies
The unbearable lightness of politicians
Drug regulation builds on trust
Inadequate testing of new drugs
Too many warnings and too many drugs
11 Public access to data at drug agencies
Our breakthrough at the EMA in 2010
Access to data at other drug agencies
Deadly slimming pills
12 Neurontin, an epilepsy drug for everything
13 Merck, where the patients die first
14 Fraudulent celecoxib trial and other lies
Marketing is harmful
15 Switching cheap drugs to expensive ones in the same patients
Novo Nordisk switches patients to expensive insulin
AstraZeneca switches patients to expensive me-again omeprazole
16 Blood glucose was fine but the patients died
Novo Nordisk interferes with an academic publication
17 Psychiatry, the drug industry’s paradise
Are we all crazy or what?
Psychiatrists as drug pushers
The chemical imbalance hoax
Screening for psychiatric disorders
Unhappy pills
Prozac, a terrible Eli Lilly drug turned into a blockbuster
Exercise is a good intervention
Further lies about happy pills
18 Pushing children into suicide with happy pills
Glaxo study 329
Concealing suicides and suicide attempts in clinical trials
Lundbeck’s evergreening of citalopram
Antipsychotic drugs
Zyprexa, another terrible Eli Lilly drug turned into a blockbuster
The bottom line of psychotropic drugs
19 Intimidation, threats and violence to protect sales
20 Busting the industry myths
21 General system failure calls for a revolution
Our drugs kill us
How much medicine do we really need and at what cost?
For-profit is the wrong model
Clinical trials
Drug regulatory agencies
Drug formulary and guideline committees
Drug marketing
Doctors and their organisations
Patients and their organisations
Medical journals
Journalists
22 Having the last laugh at big pharma
Money doesn’t smell
Creating diseases
Foreword by Richard Smith
There must be plenty of people who shudder when they hear that Peter Gøtzsche will be speaking at a meeting or see his name on the contents list of a journal. He is like the young boy who not only could see that the emperor had no clothes but also said so. Most of us either cannot see that the emperor is naked or will not announce it when we see his nakedness, which is why we badly need people like Peter. He is not a compromiser or a dissembler, and he has a taste for strong, blunt language and colourful metaphors. Some, perhaps many, people might be put off reading this book by Peter’s insistence on comparing the pharmaceutical industry to the mob, but those who turn away from the book will miss an important opportunity to understand something important about the world – and to be shocked.
Peter ends his book with a story of how the Danish Society for Rheumatology asked him to speak on the theme Collaboration with the drug industry. Is it THAT harmful? The original title was Collaboration with the drug industry. Is it harmful? but the society thought that too strong. Peter started his talk by enumerating the ‘crimes’ of the meeting’s sponsors. Roche had grown by selling heroin illegally. Abbot blocked Peter’s access to drug regulators’ unpublished trials that eventually showed that a slimming pill was dangerous. UCB too concealed trial data, while Pfizer had lied to the Food and Drug Administration and been fined $2.3 billion in the United States for promoting off label use of four drugs. Merck, the last sponsor, had, said Peter, caused the deaths of thousands of patients with its deceptive behaviour around a drug for arthritis. After this beginning to his talk he launched into his condemnation of the industry.
You can imagine being at the meeting, with the sponsors spluttering with rage and the organisers acutely embarrassed. Peter quotes a colleague as saying that he felt ‘my direct approach might have pushed some people away who were undetermined.’ But most of the audience were engaged and saw legitimacy in Peter’s points.
The many people who have enthusiastically supported routine mammography to prevent breast cancer deaths might empathise with the sponsors – because Peter has been critical of them and published a book on his experiences around mammography. The important point for me is that Peter was one of few people criticising routine
mammography when he began his investigations but – despite intense attacks on him – has been proved largely right.
He did not have any particular view on mammography when he was asked by the Danish authorities to look at the evidence, but he quickly concluded that much of the evidence was of poor quality. His general conclusion was that routine mammography might save some lives, although far fewer than enthusiasts said was the case, but at the cost of many false positives, women undergoing invasive and anxiety-creating procedures for no benefit, and of overdiagnosis of harmless cancers. The subsequent arguments around routine mammography have been bitter and hostile, but Peter’s view might now be called the orthodox view. His book on the subject shows in a detailed way how scientists have distorted evidence in order to support their beliefs.
I have long recognised that science is carried out by human beings not objective robots and will therefore be prone to the many human failings, but I was shocked by the stories in Peter’s book on mammography.
Much of this book is also shocking and in a similar way: it shows how science can be corrupted in order to advance particular arguments and how money, profits, jobs and reputations are the most potent corrupters.
Peter does acknowledge that some drugs have brought great benefits. He does so in one sentence: ‘My book is not about the well-known benefits of drugs such as our great successes with treating infections, heart diseases, some cancers, and hormone deficiencies like type 1 diabetes.’ Some readers may think this insufficient, but Peter is very clear that this is a book about the failures of the whole system of discovering, producing, marketing and regulating drugs. It is not a book about their benefits.
Many of those who read this book will ask if Peter has over-reached himself in suggesting that the activities of the drug industry amount to organised crime. The characteristics of organised crime, racketeering, is defined in US law as the act of engaging repeatedly in certain types of offence, including extortion, fraud, federal drug offenses, bribery, embezzlement, obstruction of justice, obstruction of law enforcement, tampering with witnesses and political corruption. Peter produces evidence, most of it detailed, to support his case that pharmaceutical companies are guilty of most of these offences.
And he is not the first to compare the industry with the Mafia or mob. He quotes a former vice-president of Pfizer, who has said:
It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry …
The industry has certainly fallen foul of the US Department of Justice many times in cases where companies have been fined billions. Peter describes the top 10 companies in detail, but there are many more. It’s also true that they have offended repeatedly, calculating perhaps that there are large profits to be made by flouting the law and paying the fines. The fines can be thought of as ‘the cost of doing business’ like having to pay for heat, light and rent.
Many people are killed by the industry, many more than are killed by the mob. Indeed, hundreds of thousands are killed every year by prescription drugs. Many will see this as almost inevitable because the drugs are being used to treat diseases that themselves kill. But a counter-argument is that the benefits of drugs are exaggerated, often because of serious distortions of the evidence behind the drugs, a ‘crime’ that can be attributed confidently to the industry.
The great doctor William Osler famously said that it would be good for humankind and bad for the fishes if all the drugs were thrown into the sea. He was speaking before the therapeutic revolution in the middle of the 20th century that led to penicillin, other antibiotics, and many other effective drugs, but Peter comes close to agreeing with him and does speculate that we would be better off without most psychoactive drugs, where the benefits are small, the harms considerable, and the level of prescribing massive.
Most of Peter’s book is devoted to building up the case that the drug industry has systematically corrupted science to play up the benefits and play down the harms of their drugs. As an epidemiologist with very high numerical literacy and a passion for detail, so that he is a world leader in critiquing clinical studies, Peter is here on very solid ground. He joins many others, including former editors of the New England Journal of Medicine, in showing this corruption. He shows too how the industry has bought doctors, academics, journals, professional and patient organisations, university departments, journalists, regulators, and politicians. These are the methods of the mob.
The book doesn’t let doctors and academics avoid blame. Indeed, it might be argued that drug companies are doing what is expected of them in maximising financial returns for shareholders, but doctors and academics are supposed to have a higher calling. Laws that are requiring companies to declare payments to doctors are showing that very high proportions of doctors are beholden to the drug industry and that many are being paid six figure sums for advising companies or giving talks on their behalf. It’s hard to escape the conclusion that these ‘key opinion leaders’ are being bought. They are the ‘hired guns’ of the industry.
And, as with the mob, woe be to anybody who whistleblows or gives evidence against the industry. Peter tells several stories of whistleblowers being hounded, and John le Carré’s novel describing drug company ruthlessness became a bestseller and a successful Hollywood film.
So it’s not entirely fanciful to compare the drug industry to the mob, and the public, despite its enthusiasm for taking drugs, is sceptical about the drug industry. In a poll in Denmark the public ranked the drug industry second bottom of those in which they had confidence, and a US poll ranked the industry bottom with tobacco and oil companies. The doctor and author, Ben Goldacre, in his book Bad Pharma raises the interesting thought that doctors have come to see as ‘normal’ a relationship with the drug industry that the public will see as wholly unacceptable when they fully understand it. In Britain doctors might follow journalists, members of Parliament, and bankers into disgrace for failing to see how corrupt their ways have become. At the moment the public tends to trust doctors and distrust drug companies, but the trust could be rapidly lost.
Peter’s book is not all about problems. He proposes solutions, some of which are more likely than others to happen. It seems most unlikely that drug companies will be nationalised, but it is likely that all the data used to license drugs will be made available. The independence of regulators should be enhanced. Some countries might be tempted to encourage more evaluation of drugs by public sector organisations, and enthusiasm is spreading for exposing the financial links between drug companies and doctors, professional and patient bodies, and journals. Certainly the management of conflicts of interest needs to be improved. Marketing may be further constrained, and resistance to direct consumer advertising is stiffening.
Critics of the drug industry have been increasing in number, respectability, and vehemence, and Peter has surpassed them all in comparing the industry with organised crime. I hope that nobody will be put off reading this book by the boldness of his comparison, and perhaps the bluntness of the message will lead to valuable reform.
Richard Smith, MD
June 2013
Foreword by Drummond Rennie
Evidence-based outrage
There already exist hundreds of reports of scientific studies, and many books written, about the way pharmaceutical companies pervert the scientific process and, using their massive wealth, all too often work against the interests of the patients they claim to help. I myself have contributed to the piles. So what makes this book new and worth your attention?
The answer is simple: the unique scientific abilities, research, integrity, truthfulness, and courage of the author. Gøtzsche’s experience is unequaled. He has worked in sales for drug companies either as a drug company representative pitching pills to doctors or as a prod
uct manager. He is a physician and a medical researcher and has built a high reputation as head of The Nordic Cochrane Centre. So when he speaks about bias, he bases his opinions on careful research over decades, published in peer-reviewed journals. He deeply understands the statistics of bias and the techniques of analyzing reports of clinical trials. He has been in the forefront of the development of systematic and rigorous review and meta-analysis of reports of clinical trials, to winnow out, using strict criteria, the true effectiveness of drugs and tests. He is often annoyingly persistent, but he is always driven by the evidence.
So I trust Gøtzsche to have his facts right. My trust is based on solid evidence, and on my own experience over several decades struggling with the results of pharmaceutical company influence upon my clinical researcher colleagues, and upon the public. In addition, I trust Gøtzsche because I know him to be correct when he writes about events of which I have independent knowledge.
My last reason for trusting Gøtzsche’s account has to do with my own job as an editor at a very large medical clinical journal. Editors are the first to be able to examine the written report as it comes from a research institution. Editors or their reviewers detect problems of bias in the papers submitted to their journals, and it is to editors that complaints and allegations are directed.
I have written repeated, and often indignant, editorials revealing unethical behavior by commercially-supported researchers and their sponsors. At least three editors whom I also know well, Drs. Jerome Kassirer and Marcia Angell (The New England Journal of Medicine) and Richard Smith (British Medical Journal ) have written books in which they have expressed dismay at the magnitude of the problem. Other editors such as Fiona Godlee of the British Medical Journal have written eloquently on the corrupting influence of money and the way it biases the treatment of patients and increases the costs.
I don’t pretend to vouch for all Gøtzsche’s facts – this is a foreword, not an audit – but the general picture he gives is only too familiar. While Gøtzsche may seem to talk in hyperbole, my own depressing experiences and that of medical editors and researchers I know personally tell me he’s right.