This review was completed in May 2024 for the subject Ethics and Scientific Research within the framework of the Master in Theoretical and Practical Philosophy of the National University of Distance Education (UNED).

Review: Mala farma: Cómo las empresas farmacéuticas engañan a los médicos y perjudican a los pacientes (Contextos). Ediciones Paidós. Edición de Kindle. 2013.

Ben Goldacre is a British doctor and university professor especially known for his activity as a scientific communicator. For eight years he published a column in The Guardian entitled “Bad Science”, a title that he would also give to the corresponding book. In it he addresses bad scientific practices and the problem posed by pseudosciences. In addition to his activity as a columnist and writer, he has participated in numerous conferences, including several TED Talks with millions of views. It is important to highlight that the different causes that he has been denouncing have a practical reflection in his professional activity. Goldacre heads the Bennett Institute for Applied Data Science at the University of Oxford, a multidisciplinary team of academics, doctors and software developers who bring together skills and knowledge to turn large data sets into tools and services, as well as purely academic research articles. He is also the founder of AllTrials, an initiative that demands that clinical trials, past and present, should be registered and their results published.

In the book we are reviewing today, “Bad Pharma”, Goldacre argues that medicine is guided by biased data, with the corresponding danger to the health of patients. Throughout the book he will argue that, although medicine should be based on evidence, the tests are often riddled with errors and the pharmaceutical industry hides research from doctors, whose training is largely subsidized by it. According to Goldacre, regulation “contains perverse incentives” and regulatory bodies do not perform their functions properly, since “they approve useless drugs and hide from doctors and patients data on their side effects, without giving them any importance” (p. 3).

For Goldacre, the root of the problem is that “drug tests are carried out by their manufacturers, using poorly designed trials on a small number of inadequate and unrepresentative participants, and analyzing them using methodologically erroneous techniques, to the point that the benefits of the treatment are exaggerated” (p. 4).

To develop his thesis, the author will guide us through six chapters and an epilogue. He will start from his fundamental premise, “in the case of clinical studies financed by the industry, it is most likely that positive results will be obtained, unlike what happens in independent clinical studies.” This statement allows us to highlight how Goldacre seeks to support all his claims with numerous studies and data. Indeed, the author will cite numerous sources throughout the book. According to one of the studies mentioned, 85% of the more than five hundred clinical studies financed by the pharmaceutical industry that were examined were positive (Bourgeois, Murthy, Mandl, 2010). The author leads by example, and so uses systematic review to support these conclusions, concluding that, in trials financed by the industry, as a whole, the probability of giving favorable results is greater (Bekelman, Li, Gross, 2003). How is it possible, then, for a clinical trial or a scientific study to be biased? Goldacre will describe numerous practices of the pharmaceutical industry in the following chapters, but he already anticipates the answer: “publication bias”: when the results are not favorable, they are not published. This would be extremely serious, given that medicine would have been developed on the basis of distorted evidence.

The author continues his exposition by taking a step back to explain the process that goes from the invention of medicines until their prescription is finally authorized (p. 131). It is worth pausing to consider the role played by clinical research organizations or “CROs”, as they are called in English. These are private companies subcontracted by the pharmaceutical industry to carry out clinical trials. The commercialization of clinical trials raises new dilemmas regarding impartiality. If our incentive as a private company is to continue providing services to the industry, it seems logical to think that our work is influenced by it. These conflicts of interest are not exclusive to medicine and the pharmaceutical industry. Let us think about the auditors, who are hired by the companies themselves. Among the most paradigmatic scandals in recent history in Spain, the Bankia scandal stands out (Gutiérrez,2024).

In chapter three, Goldacre focuses on the role of the regulator, which is key to allowing any drug to be prescribed once its efficacy has been demonstrated, and states that “there are serious problems both in the way drugs are authorised and in the way their safety is monitored once they are marketed” (p. 208). Chapters four and five delve into irregularities and bad practices surrounding clinical trials and the role of different agents in the health and academic system, as well as how some of the problems could be addressed.

The final chapter illustrates the marketing activity of the pharmaceutical industry. The author analyses the efforts of the industry to try to get a doctor to prescribe a particular drug. The marketing budget is translated into advertising in medical journals, pointing out the benefits and, according to Goldacre, mitigating the risks and avoiding unfavourable comparisons. The industry also relies on the figure of “medical representatives” and invests in congresses where doctors will continue their training. As far as training is concerned, the controversy extends again to other fields beyond medicine. In the judicial field we have found numerous controversies in Spain regarding the payment to judges and prosecutors for the delivery of courses and conferences (Fundación Hay Derecho, 2016).

Goldacre uses belligerent language throughout the book. This mention does not seek to diminish the importance that the problem that the author has been denouncing undoubtedly has, not only in “Bad Pharma”. We believe, however, that it is worth highlighting, because in our opinion the tone used can have a negative effect on the dissemination of the message. Let us think, for example, about how these criticisms will be received by the millions of people linked to the pharmaceutical sector, people who, as Goldacre himself highlights, are a fundamental part of solving the problem.

As we have already highlighted at the beginning of the review, if there is one thing that should be praised about Goldacre's work in “Bad Pharma” it is the support of his statements, providing a very wide variety of sources. However, we can sometimes find statements that do not have the corresponding support, something that we consider can be explained by the tone used, as we have just highlighted. Without a doubt, using a direct style allows the author to reach a much larger audience, but he runs the risk of falling into value judgments and even demagogy.

In this line, the statement he makes at the beginning of the book is especially striking: “we all know intuitively, from things we hear, that something is wrong in medicine, but many of us – including doctors – do not know exactly what” (p. 4). In our opinion, this type of message, which the author himself fought in his book “Bad Science”, is very dangerous. It does not seem reasonable that we should question science based on our intuition. León Olivé, in his book, “Good, Evil and Reason”, reminds us that science, by default and based on its methodology, is open to studying contrary evidence. Aren't the studies that have proven that industry-funded trials are more likely to yield favourable results good proof of this?

In our opinion, Goldacre's statements are emotionally charged and he sometimes appeals to prejudices or makes value judgements. For example, the author complains that the value of GSK's shares was not affected by the €3 billion fine for the fraud process in July 2012 (p. 416), as if the value of the shares depended on the pharmaceutical industry itself and not the market in general. Also, throughout the book, he mentions on several occasions the industry's investment in advertising and marketing, for example: "A quarter of the pharmaceutical industry's income is spent on advertising, double that invested in research and development" (p. 376). Is this relevant? We don't know, at the very least a detailed analysis would be necessary and the author does not provide evidence. In relation to what can we consider excessive that the pharmaceutical industry invests twice as much in marketing as in R&D? Is it enough to judge whether the marketing budget is adequate in relation to what is allocated to R&D? Shouldn't we analyse the competitive dynamics of the sector and put it in relation to other industries?

On the other hand, although the solutions proposed are attractive and logical (e.g. evidence-based medicine through an information structure “that allows valid evidence to reach the right doctor at the right time”, p. 295), we believe that Goldacre should emphasize more that we are dealing with a global company. It is inevitable to think of cases such as Spain, where there are major administrative barriers between the regions themselves. At the same time, it must be remembered that many of his proposals are already in place, both from an ethical point of view (i.e. deontological codes, universal declarations, etc.) and a regulatory one. It would therefore be necessary to analyze the reasons why controls are not put into practice and here we enter the moral and political terrain.

All this does not invalidate for us the author's main argument, that is, the importance of the missing data and the need to address reforms so that the objective sought by regulation, the efficacy and safety of drugs, becomes a reality. We also believe that his conclusions have consequences that go far beyond this. I am not talking about the obvious unintended consequences of the development of the pharmaceutical industry, but about the impact on equity of the questionable practices described by Goldacre. It seems obvious that those with greater economic capacity will be able to access health solutions that the average citizen does not have access to, especially in the face of the apparent passivity of the State. Beyond the value of life itself, we cannot forget that our state of health will determine, along with basic needs such as food or housing, our ability to develop in society (Sen, 1997). The passivity of the State and of society in general in the face of the bad practices of the pharmaceutical industry and its consequences is, in our opinion, one more symptom of the lack of concern for the whole and the common good (Sandel, 2011).

Although the challenge is very important, even vital, it is worth highlighting the numerous actions proposed by Goldacre throughout the book and which the author himself has been putting into practice, with the personal risks that this entails, throughout his life. What will the rest of us do about this? We can start by recommending a calm reading of “Bad Pharma,” a challenge in itself in today’s digital society, where denunciation and conflict in a few characters are paramount and where it is more difficult to combat misinformation and the spread of bad science.

References

Bekelman, J.E., Li, Y., Gross, C.P. (2003), «Scope and impact of financial conflicts of interest in biomedical research: a systematic review», British Medical Journal, vol. 326, págs. 1.167-1.170.

Bourgeois, F.T., Murthy S., Mandl, K.D. (2010). «Outcome Reporting Among Drug Trials Registered in [ClinicalTrials.gov](http://clinicaltrials.gov/)», Annals of Internal Medicine, vol. 153, nº 3, págs.158-166.

Fundación Hay Derecho (2016). Flash Derecho: Debate sobre los cobros de jueces y magistrados por conferencias o cursos en entidades privadas. Hay Derecho. Disponible en: https://www.hayderecho.com/2016/05/31/flash-derecho-debate-sobre-los-cobros-de-jueces-y-magistrados-por-conferencias-o-cursos-en-entidades-privadas/

Goldacre, B. (2013). Mala farma: Cómo las empresas farmacéuticas engañan a los médicos y perjudican a los pacientes (Contextos). Ediciones Paidós. Edición de Kindle.

Gutiérrez, H. (2024). La Audiencia levanta la suspensión de la multa de 10,4 millones a Deloitte por la auditoría de Bankia. Cinco Días. Disponible en: https://cincodias.elpais.com/companias/2024-03-06/la-audiencia-levanta-la-suspension-de-la-multa-de-104-millones-a-deloitte-por-la-auditoria-de-bankia.html

Olivé, L. (2000). El bien, el mal y la razón. Paidós.

Sandel, M. J. (2011). Justicia. ¿Hacemos lo que debemos? Penguin Random House Grupo Editorial.

Sen, A. (1984). Resources, Values and Development. Harvard University Press.