Goldacre, B. Bad Pharma: How drug companies mislead doctors and harm patients. London: Fourth Estate, 2012.
Ben Goldacre has written an important book that brings together a number of serious concerns about the way medicines are researched, sold and used. He makes a big claim that medicine is broken because of problems with both the knowledge and methodology on which it is based. He does it lucidly, often entertainingly in a style that is easy to read but does not flinch from complex technical areas and which while it is clearly meticulously researched wears its learning lightly.
The whole book is an extended argument to make the case that ‘Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients and analysed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials produce results that companies do not like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects’. Goldacre is clearly cross, and rightly so, but he manages to make this case very effectively and in a balanced way even though some of the evidence is truly shocking.
One of the most worrying themes of the book is the extent to which important data about trials have gone missing either through publication bias because negative trials are much less interesting or as a result of cherry picking. Publication bias would matter less if there were reliable registers of trials but, in a common theme in this book, repeated promises to develop and enforce these have failed to deliver. That this matters is demonstrated with real life stories about the impacts of this on patients and doctors and this connection of the arcana he discusses with the real world is one of the engaging features of the book.
Not only are the data missing but there are serious concerns about what we have. The book explores the ways in which the results of trials are distorted such as problems with how they are conducted, the perils of subgroup analysis, changes in the objectives during the trial, using surrogate outcomes, finishing trials early and many more. He explains these well. Again, promises to fix these issues have been made and not delivered. The commercialization and out sourcing of trials produces some new hazards and a danger that the drug being used in one country may have been tested on populations quite unlike those being treated, not only because of the exclusion of older patients with co-morbidities but also because we do not know enough about how different ethnic groups react to some medicines.
The behaviour of the regulators gets a well-deserved chapter to itself. There is a general problem of regulatory failure and if the issue were not so important some of this would be hilarious. The European Medicines Agency comes out particularly badly from this story and seems unembarrassed in behaving as a bureaucratic monster with a shameless disregard for the people it is supposed to serve, pathologically secretive and with significant conflicts of interest – another theme in this book. From the evidence in this book it has lost sight of its purpose. The US and UK regulators do not come out of this story much better. Regulators have a low bar for approval and their failure to use comparisons against the best available treatment is a serious issue but one that seems tame compared with some other aspects of their behaviour.
Others with a duty to deal with these problems are not doing very well either. Journal editors, Royal Colleges, ethics committees and opinion leaders in the medical profession and others all come in for some significant criticism for failing to act and in some cases stories ranged from the embarrassing to the nearly criminal. Some of this seems to be due to conflicts of interest which permeate this territory, some to what seems to be complacency or an erroneous belief that these problems have been fixed.
The book has a long chapter on marketing – not least because, despite the complaints of the industry about the costs of drug development they spend twice as much on marketing as they do on R&D. Some of this is more familiar although it is no less shocking. There is a good exploration of the problems of using opinion leaders, the sometimes dubious role of medical ghost writers, how to go about creating new diseases for marketing purposes and the extent to which patients’ groups have been drawn into the marketing effort which should be much more of an embarrassment to them than it seems to be.
All this could seem rather negative but Goldacre provides a number of practical suggestions about how to deal with the issues he raises. In particular, he advocates more trials and the pragmatic use of big databases such as the General Practice research database.
The reaction of the industry to this book has been rather disappointing and unconvincing. I am not aware whether the regulators have responded at all. Perhaps we should not be surprised. If you are concerned about any of these issues you should read this book. It will not reassure you but it will give you some useful ideas about what can be done.
DECLARATIONS
Competing interests
NE is a part time employee of KPMG LLP which provides consulting and other advice to pharmaceutical companies. He is not directly engaged in this activity
Funding
None declared
Ethical approval
Not applicable
Guarantor
NE
Contributorship
This book review was commissioned by the Editor
Acknowledgements
None