Review by Michelle Li^[1], Medicine Faculty, Monash University, Australia

In the medical profession, the backbone of the prescription process is formed by evidence. This makes logical sense: doctors, as well as patients, base informed decisions on whether or not a certain drug is deemed therapeutic or harmful. But from where is this knowledge gained? Medicine changes all the time and, once out of training, doctors have no standardised source of information. Instead, they must assume this education themselves, primarily through researching clinical trials and the journals in which they are published.

However, as Goldacre warns in Bad Pharma, it is often not as simple as this. While it is known that the pharmaceutical industry spends billions of dollars on extensive marketing to try to change the prescription habits of doctors, a more unethical strategy goes largely unnoticed: the manipulation of clinical trials and the misrepresentation of their findings. From small sample sizes to adjusted ratios and unpublished negative results, the evidence upon which we make treatment decisions skews greatly in the manufacturer's favour. Indeed, in a global market worth over US$300 billion a year, pharmaceutical companies are interested in more than simply improving patient health: they are in the money business, and business is booming.

But this phenomenon cannot be examined solely through a financial lens. Profits mean nothing when they come at the expense of patients that have been harmed, or even killed, by treatments with exaggerated results or unpublished side effects. Goldacre reminds us that, as medical professionals, our duty is always to our patients first; we must recognise that we are never given all the information that we need, and that we must question those who hold it from us.

Throughout Bad Pharma, we learn how those in positions of power have failed us. Universities, ethics committees, regulators, journal editors and government bodies alike have all recognised and promised to rectify the deceitful nature of the pharmaceutical industry, yet prospective follow-up procedures have often revealed non-compliance. So who are doctors and patients supposed to trust, if these once-trusted gatekeepers are found to be corrupt? If previous solutions have involved empty assurances and continued unaccountability, what else is there to do?

This is where it is important to note that the overall tone of this book is not one of cynicism. At the end of each chapter, Goldacre outlines practical and, indeed, effective actions that everyone - from industry to doctors to patients - can adopt to begin improving the state of affairs. After all, in a profession where treatments are rapidly changing and new drugs are always being developed, it is neither foolish nor idealistic to believe that systematic change can be effected to transform this culture from being profit-driven to being patient-centered and utterly transparent.

 

Review by Donald Singer^[2], Warwick Medical School

Medicines have significant costs, both financial and in terms of serious adverse effects. Treatment should therefore only be prescribed and continued when the benefit outweighs the risk. This presupposes that health professionals, patients, and policymakers have trustworthy evidence to support clinical use of medicines. It is vital that research on medicines is objective in order to show whether proposed treatments are effective for improving clinically meaningful outcomes for patients, how they compare to existing remedies, and the relative and absolute cost implications of adopting the treatment.

In his seductive polemic Bad Pharma, psychiatrist and 'Bad Science' Guardian columnist Ben Goldacre raises major concerns about the quality of evidence on the efficacy and safety of specific drugs and classes of treatment in clinical use. His book has added to recent public concern about medicines, their safety, and the probity of pharmaceutical companies. This background concern for the public has been inspired both by works of fiction, for example the film Side Effects, set within a corrupted psychotherapeutic sector, and John Le Carre's African novel The Constant Gardener, which raises important questions about the ethics of clinical research on anti-infective agents in developing countries. And judging by a series of very large fines imposed on major pharmaceutical companies for a wide range of reported major errors of omission and commission, including concealed data on safety, and encouragement of doctors to prescribe off-licence, i.e. to patient groups for whom there is no or insufficient evidence on effectiveness or safety of medicines.

Goldacre's thesis is that the business of getting pharmaceuticals licensed for clinical use, and then maximising uptake of a licensed drug by prescribers and patients, has too often compromised study design, and openness in data sharing about study results. He also asserts that national drug regulatory organisations are at best insufficiently curious or insistent that the right studies are performed in the right groups of patients, ask the right questions about cost and effectiveness, and add value beyond that of previous treatments. He gives multiple, referenced examples of failure to conduct robust, well-controlled studies, failure to select appropriate comparators, blocking by both pharmaceutical companies and regulators of requests, and alleged intimidation of curious researchers.

Regular training updates are expected within professional appraisal as mandatory for permission to continue in professional medical practice. Goldacre points out that health services have found it convenient to rely on the pharmaceutical industry both to deliver education directly and to provide unrestricted educational grants. This results in temptation on both sides to omit discussion of inconvenient findings on medicines within the portfolios of supporting companies.

Goldacre is aware of the risk that his audience will undergo concern fatigue in the face of the unremitting enormity of the errors and concerns he describes. His strategy is twofold: repetition, to remind readers about major issues; and frequent asides to the reader, either to reinforce a key point, or as calls to action. Additional illustrations would have helped the lay reader to follow some of the more complex arguments.

Goldacre accepts that not all drugs and not all Pharma are bad. And most readers will be well aware of many pharmaceutical successes: from treatment of previously lethal infections, including HIV, to major advances in the treatment of cancer, and the prevention of cardiovascular disease. Occasional case histories of pharmaceutical success, with analysis of what went well, would have strengthened the impact of his many case histories of poor practice.

Reading Bad Pharma raises many obvious questions. How widespread are the problems highlighted? How important are they for overall patient and public health: minor and widespread, major but uncommon, major and common? Are these serious but historical concerns and now resolved or still important current causes for concern?

Many of these concerns are reported as being addressed by new codes of industry practice, planned open-access disclosure by prescribers and clinical trialists in receipt of industry funding, and moves to require open access to all clinical trial data. And clinical trials must not proceed unless an ethical committee has approved the proposed research. In the UK at least, studies must be registered before the ethics application will be considered. Goldacre and his many sources will be on hand to alert the public to the success or otherwise of these initiatives, and to press for further steps, including publication of all results of studies, irrespective of outcomes.

 

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Notes

[1] Michelle Li studies medicine at Monash University. Since 2011, she has been the editor of a quarterly student journal and has held the role of Publications Chair on her university's medical society. An interest in evidence-based clinical practice, public health and health policy has led to her ongoing involvement with advocacy and print media.

[2] Professor Singer is a member of the Council of the British Pharmacological Society, Secretary of the European Association for Clinical Pharmacology and Therapeutics, President of the Fellowship of Postgraduate Medicine, and Chair of the Advisory Board for the journal Health Policy and Technology.

He gained extensive experience of managing blood pressure while working within the Blood Pressure Units at Charing Cross & Westminster Hospital Medical School, London (1985-1989) and at St George’s Hospital Medical School, London (1989-2003). From 2006-9 he was a member of the Executive Committee of the British Hypertension Society.

Professor Singer is interested in drug discovery, vascular mechanisms and non-invasive biomarkers important for prevention and treatment of cardiovascular disease, and improving safety and effectiveness in use of medicines. The Pocket Prescriber he co-authors is now in its 6th edition since 2004. Its first daughter publication - Pocket Prescriber Emergency Medicine was published in September 2013. Professor Singer is also interested in promoting better public understanding of new treatments, and the benefits and risks of medicines.

He is an active clinician working with academic and clinical colleagues in primary and secondary care to improve blood pressure services in Coventry, Warwick, Rugby, Nuneaton and the surrounding area.

In 2009 with Michael Hulse he co-founded the annual international Hippocrates Prize and annual international Symposia for Poetry and Medicine. In 2013, he co-founded the International Hippocrates Society for Poetry and Medicine and the Hippocrates Press.

 

 

To cite either of these reviews please use the following details: Li, M. OR Singer, D. (2013), Ben Goldacre (2012), 'Bad Pharma: How drug companies mislead doctors and harm patients', Reinvention: an International Journal of Undergraduate Research, Volume 6, Issue 2, http://www.warwick.ac.uk/reinventionjournal/issues/volume6issue2/lisinger Date accessed [insert date]. If you cite these reviews or use them in any teaching or other related activities please let us know by e-mailing us at Reinventionjournal at warwick dot ac dot uk.