Is bad Pharma just bad science?

Issue: 138

Sophie Williams

Ben Goldacre, Bad Pharma (Fourth Estate, 2012), £13.99

The threat to our NHS is something we all know about, but Bad Pharma exposes another crisis in medicine: the power of the pharmaceutical industry, “Pharma”, to protect its private interests. Ben Goldacre is a practising doctor and journalist, author of Bad Science (2009) and the same titled Guardian column, which has run since 2003. He is interested in “unpicking bad science” as “the best way to explain good science” and is committed to making such debates accessible to a wide audience. Bad Pharma, subtitled “How Drug Companies Mislead Doctors and Harm Patients”, exposes bad regulation and bad science, but also offers insights into the mechanisms of Pharma’s grip on the practice of medicine.

Goldacre explains how Pharma bypasses legislation to retain profitability and how regulatory bodies are more concerned with commercial protectionism than standards of healthcare. The EU’s bureaucratic bodies, created to regulate Pharma, are affiliated with industrial rather than health departments, and conflicts of interest surrounding regulator’s funding and individual’s lobbying potential are concealed and unchallenged. The structures in clinical research reflect wider neoliberal economic policies. The deregulation of clinical trials has resulted in the creation of independent Clinical Trials Organisations (CTOs) which provide trial services at competitive rates. They are able to “undercut” trials conducted in countries with more protective or complete legislation concerning ethics and clinical research. In a sample of clinical trials conducted across developing countries that CTOs are expanding into, less than half required an ethics review board, a basic requirement of clinical trials.

Changes in US legislation in 2008, designed to bring more trials back home, saw the removal of ethical considerations in favour of procedural ones. There is also a trend towards greater drug approval rates. During the Reagan years the rate of drug approval in the last month of the financial year increased significantly relative to other months, indicating a pressure to release new drugs without the strength of evidence being the principal factor.

Commercial interest is allowed to play such an important role, Goldacre argues, because the scientific evidence is manipulated by medical trial design, statistical analysis and publication practice. The lack of pressure on Pharma to provide accurate data, for Goldacre, results from the inability of doctors and the scientific community to confront and undermine inadequate evidence for the safety and effectiveness of new drugs over existing—and often cheaper—alternatives. However, Goldacre limits his argument to suggesting that changing the code of conduct towards better science would be sufficient to undermine Pharma’s power. This is made clear in his chapter on “Better Trials”, where the war against “Bad Pharma” is played out in the ideological battleground between “better” and “bad trials”.

Pharma has turned towards bad science because of the nature of scientific method under neoliberalism. Capitalism has always put profits first, but increasingly Pharma has found it harder to squeeze profits from making useful drugs. The requirement for novel, “high impact” science sidelines criticism and positive results become the primary interest. Many scientific disciplines rely on quantitative rankings for novelty and therefore funding, and, for Pharma, profits depend upon and reinforce this trend. Goldacre shows that the bias towards positive results is higher by a factor of almost two thirds in research funded by industry. This is consistent with the requirement for positive results to illustrate clinical benefit, giving the best chance for a market and maximised profit. At the same time, the loss of investment from research and development and injection into marketing means that, more often than not, a new drug is nothing of the sort. The interest in marketing “me-too” and “me-again” drugs illustrates the changing nature of the value-form, the detachment from the production of better drugs in favour of bigger profits.

Goldacre goes further to show that Pharma tampers with data, albeit short of outright fabrication, to show positive results. Trial data goes unpublished or missing, and statistical mishaps appear which give greater weighting to potentially random conclusions. When this gives rise to a positive result, it is published. When it doesn’t, it is deleted. Such tampered evidence harms patients, not only during trials themselves, but more generally through limiting the ability of doctors and patients to make informed decisions.

There are interesting discussions about how academic publications, educational materials and the intervention into the media by Pharma distort cultural attitudes towards certain diseases, both lay and professional. Herceptin, a breast cancer drug costing tens of thousands for each treatment, became a headline test-case for modernisation in centralised healthcare. Two thirds of reports about Herceptin used individual miracle recoveries to illustrate the effectiveness of the drug, even when these women were sourced from PR companies paid by Roche, the manufacturer. The side-effects were rarely mentioned.

The distortion of the benefits of a drug through marketing is paralleled in the marketing of symptoms and diseases themselves. Over-diagnosis and the creation of new forms of disease are particularly relevant to the design and marketing of depression medications.

Goldacre is deeply critical of the political and economic interests that have allowed the industry to go practically unregulated, but it is only by reading between the lines that we see inequality and exploitation at the hands of the pharmaceutical industry to be as crucial as statistical malpractice in boosting profits. His in-depth investigation into the interests of private medicine foreshadows, although never mentions, how privatisation and deregulation in the NHS will affect the industry’s practice, and therefore patients in the UK. Similarly, the statistical bias introduced by class, for example mistaking the benefits of hormone therapy treatment for those of a privileged lifestyle, is critiqued as a statistical anomaly but not developed into an analysis of the inequality of the provision of medicine more generally.

Goldacre identifies the responsibility due at every level: governments, regulators, academics, doctors and even patient groups. His message, again aimed at policy makers and patients alike, is to ensure that profit is kept at the margin when drugs are approved for use. Whether this approach will undermine the power of Pharma, I’m not sure.