Ben Goldacre. Bad Pharma. London: Fourth Estate; 2012. Pp 448 paperback. ISBN978-0-00-750955-3 Rs 499.00
I had read Dr Ben Goldacre’s earlier book Bad Science, an excellent description of scientific methods, their use and misuse; but had hesitated to buy Bad Pharma when I first saw it in bookshops. This was because I thought I already knew all about the shenanigans of the pharma companies, and that this book would only reiterate what other authors had recorded. I was wrong. There is a whole lot of information here which is new to me and probably will be to you as well. In Ben Goldacre’s clear prose, the serious problems underlying the scientific practice of medicine are well exposed. It may be a cliché to say that the book is an eye-opener, but well, an eye-opener it is. A true believer in evidence-based medicine, Dr Goldacre demonstrates that the available evidence is often seriously flawed. Worse, the flaws have been introduced and perpetuated systematically by, or at the instance of, the pharmaceutical companies, in order to maintain their profits. In this, the companies have been aided and abetted by researchers, the regulators, the medical journal editors; in brief, all the gatekeepers have been compromised.
The first and most important problem that Goldacre highlights is missing data. The data from a very large number of trials is never published. For many trials, the raw data is never made public and only the analysis is. This can be problematic, because the analysis can be fudged to show significant benefits where there are few or none, and/or to hide harms. Attempts to overcome the problem by, for example, introducing registries where all the trial data is entered, and a commitment by The International Committee of Medical Journal Editors that only registered trials would be published, have not worked, because of a failure by these institutions to adhere to their commitments. These are examples of what Goldacre excoriates as false fixes, i.e. institutional responses which pretend to solve the problem.
The next problem that Goldacre highlights is the failure of the regulatory bodies like the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) of the USA. The main problem here is that these agencies, which are supposed to supervise the drug industry, have been captured by them (regulatory capture), and are far from effective in protecting the public.
The third problem is bad trials. Goldacre gives numerous examples of how trials are manipulated in order to serve the purpose of the pharma industry. Sadly, many researchers actively collude, and many are passive spectators, fully aware that fraud is being perpetrated but doing nothing about it. For me, it was particularly distressing to read that even journals with high academic prestige, such as The New England Journal of Medicine and The Lancet, make huge amounts of money from the pharmaceutical industry and are therefore unwilling to do anything substantial to stem the rot. It seems that the sanctity of science is seriously compromised, and those charged with defending it have failed us all.
A very large number of the articles which appear in even the most prestigious journals are ghost-written by the pharma industry and opinion leaders identified by the industry to put their names on the articles. In an informal nexus, the peer reviewers are also part of the consensus opinion, carefully nurtured over many paid conferences, and therefore fail to look at the data carefully and critically. Dr Goldacre shows how many of the guidelines to treatment relied upon by the majority of practitioners are not based on sound data, because the data is not available, but this is not acknowledged! The Cochrane Collaboration is an honourable exception.
Dr Goldacre offers a number of solutions to the problems he highlights. These are mostly calls to the practitioners to not be enticed by the pharma industry. He is part of a major initiative to acquire better data by using the General Practitioners Database in the UK and this may provide truly useful data in the future. However, I think the key question is how to have a successful drug discovery and marketing programme without the profit motive. As long as profits are the prime force pushing the industry, there will exist strong incentives to make profits as quickly and as easily as possible, and all kinds of ethical problems will remain.