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Sunday, 9 December 2012
Bad Pharma + Good Profit - "Saints or sinners." Book Review by Sir Michael Rawlins (Chairperson of N.I.C.E.) Courtesy of the LANCET
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients.
Fourth Estate/Harper Press, 2012
Pp 350. £13·99. ISBN-9780007350742
Public and professional opinion about the pharmaceutical industry is polarised. Some believe that drug companies are saints and, by developing extraordinarily effective new medicines, they either save lives or substantially improve people's quality of life. Others see the industry as sinners, interested only in making profits for themselves and their shareholders, and unconcerned with the welfare of patients. As the title of Ben Goldacre's book indicates, he sides with the “sinners”.
Goldacre's book is concerned with describing many of the bad things that the pharmaceutical industry has done over the past 20 years or so. In particular, Goldacre criticises the industry's consistent, and continuing, failure to publish the results of all its clinical research. He rightly includes not only the failure to publish many clinical trials but also the findings from early phase 1 studies in volunteers.
Such criticisms, of course, are not new. Iain Chalmers, for example, has written extensively about the failures of both industrial and academic investigators to publish the results of clinical trials, leading, as a result, to “publication bias”. The industry, in response to adverse publicity in both the professional and lay media, have (albeit only in part) responded. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has thus, since 2009, required member companies to disclose the results of clinical trials of products that have been approved for marketing in at least one country. The fact that pharmaceutical companies have made some attempt to “put their house in order”, only because of external criticism, adds to the weight of Goldacre's complaints. The IFPMA's position, however, still (at least potentially) leaves unpublished those studies of products that either fail to show benefit or are unsafe.
Goldacre is equally critical of the industry's many and varied promotional practices. In an overly long chapter on marketing, he gives special attention to the multifarious approaches taken to “direct to consumer” advertising in the USA. Anyone who has had the misfortune to watch American television will have seen the pervasive drug adverts that interrupt prime time shows. These adverts are presumably effective in enhancing sales, although I find them just plain boring. In the USA, almost the only developed country to allow direct to consumer advertising, the phenomenon of “celebrity endorsement” has recently emerged. More generally, Goldacre claims that the industry spends twice as much on marketing as on research and development (R&D). Although this may be true in the USA, it is not so in the UK. Under the provisions of the Pharmaceutical Price Regulatory Scheme, companies can only spend up to about 6% of their sales to the National Health Service (NHS) on marketing, but up to 30% on R&D.
But Goldacre's anger is directed not only at bad pharma. He also criticises bad academia, bad drug regulators, bad patient advocacy groups, bad journal editors, and bad doctors more generally. He even has a (relatively modest) go at the UK's National Institute for Health and Clinical Excellence (NICE).
Goldacre accuses academics of not only failing to publish the results of their own trials, but of conniving with pharmaceutical companies in the selective reporting of the results of studies with which they have been involved. There is no doubt that this has happened in the past, but the extent to which it continues is unclear. Goldacre does though quote evidence indicating that, in 2005, nearly two-thirds of 122 US medical schools allowed clinical trial agreements with pharmaceutical companies to be “confidential”; and about a half allowed sponsors to draft the final report. The International Committee of Medical Journal Editors insisted, in 2001, that the lead author of any study must confirm full access to the data. He rightly accuses doctors, generally, to have enjoyed—at least in the past—too much food and drink from drug companies in return for a little gentle postgraduate education.
Drug regulatory authorities, especially in the EU and the USA, are criticised for their excessive secrecy, and for their continuing failure to allow full disclosure of data on both the efficacy and safety of the products they regulate. Goldacre is correct that UK regulatory authorities have, in the past, been too reluctant to release data, particularly information provided “in confidence” (at least partly for alleged legal reasons). It is a pity though that he doesn't mention the fact that in the UK the Medicines and Healthcare products Regulatory Agency (MHRA) have made spontaneous reports of adverse reactions available online for many years.
Goldacre has some harsh words about patient advocacy organisations. He accepts that they have an important role in bringing patients together, disseminating information, and helping to lobby on behalf of the people they represent. But when they obtain grants from drug companies to fund their activities, the relationship can become complicated. As Goldacre describes, patient advocacy groups have criticised NICE for the decisions it has made about drugs of particular importance for their members. It is right that they should do so, and I do not complain about their activities in this context. What I do resent, and Goldacre discusses this too, is the failure of these organisations to criticise companies for the price they seek to charge from the UK's NHS. And I particularly deplore the use of public relations firms, paid for by drug companies, for lobbying actively on behalf of patient advocacy groups.
Nor do the editors of journals escape Goldacre's ire. The pressure on editors to publish articles about research sponsored by drug companies is not so much about the advertising revenue (though that is substantial) but about the reprint orders that are placed once a particular article is published. A single published article of a study sponsored by a drug company can bring in a reprint order of 100 000 copies (at perhaps US$2—5 a copy). Richard Smith (former editor of the BMJ), as well as The Lancet's own Richard Horton, deserve great credit for being honest about this issue in public.
There is much to praise in Bad Pharma, but some readers might find the book too long and impenetrable. It is a cross between scholarship, with numerous references to relevant publications, and polemic. Few of the examples of drug companies' malpractice in Big Pharma are new. Indeed, some attempts have been made both by the industry, and by regulatory authorities, to improve matters—although Goldacre has little confidence in these.
Goldacre maintains that the literature on the effectiveness of modern drugs is fatally flawed, because of the failures of drug companies to publish the results of all the trials they have sponsored. As a consequence he believes that many—perhaps most—of the products in regular use may lack a rigorous evidence base. This is his explanation for the first sentence of his book: “Medicine is broken”. Goldacre contends that only when drug companies and regulatory authorities publish the full results of all their past studies can the literature be cleansed of error. Apart from the difficulties of even retrieving the final reports of studies undertaken during the 1970s, 1980s, and 1990s, it is a reductio ad absurdum to believe that the drugs originally licensed in that period, and still in widespread use, are no better than placebo. Does anyone really suspect that ibuprofen, statins, or angiotensin-converting-enzyme inhibitors—to name just a few drugs introduced over the past 30 years—are no better than placebo?
In his desire to paint drug companies and regulatory authorities in the worst possible light, Goldacre omits salient facts from his discussion. There is thus a long account of the reluctance of Roche to disclose the results of some of the trials with its antiviral agent oseltamivir (Tamiflu). But Goldacre does not mention that GlaxoSmithKline has recently provided individual patient data on all its trials with their own antiviral agent zanamivir (Relenza) to the Cochrane Collboration. Goldacre also castigates the European Medicines Agency (EMA) for its lack of transparency. In particular, he notes that neither its register of clinical trials (EudraCT), nor its database of spontaneous reports of suspected adverse reactions, are publicly available. Both, however, are now publicly available online: EudraCT since 2011 and spontaneous reports since June this year.
Whilst Goldacre offers his own remedies, and some are sensible, he does not seem to appreciate the extent of the culture change that is necessary. This is not confined to expecting—as a default position—that the entirety of the clinical data about a particular pharmaceutical product is placed in the public domain. It is about expecting drug regulatory authorities to be transparent about the reasons for reaching particular decisions. This should involve, for a start, the advisory committees of the EMA meeting in public. The US Food and Drug Administration does this so why not the EMA and, come to that, the MHRA?
The only organisation with the knowledge and skills to develop new medicines is the pharmaceutical industry. We need to imbue an environment that encourages the industry to develop new medicines. Society, globally, desperately needs new medicines that provide the same benefits for patients with malignant and neurodegenerative diseases as the industry has so effectively done in the past for those with cardiorespiratory disorders. The environment, therefore, needs to ensure that the industry's creativity is appropriately rewarded. At the same time, the industry's unacceptable practices that Goldacre describes in Bad Pharma must be confined to history. It is this balance, between the beautiful and the ugly, that Goldacre fails to achieve. As it stands Bad Pharma is a book intended to shock the reader rather than propose eternal verities. We need to find ways to enhance the industry's saintliness and expiate its sins.
I am Chairman of the National Institute for Health and Clinical Excellence.