Bad pharma: how drug companies mislead

doctors and harm patients

Ben Goldacre 2012 Faber & Faber £13.99 $28.00

Everyone working in the pharmaceutical industry should read

this book. This books catalogues in detail, with supporting data,

how the pharmaceutical industry has distorted the business of

evidence-based medicine, despite the best efforts of statisticians

in the pharmaceutical industry.

You should read this book if for no better reason than that

everyone outside of the industry is reading this book. The take

home message for those outside the industry is that ’drugs

are tested by the people who manufacture them, in poorly

designed trials, on hopelessly small numbers of weird, unrepresentative

patients and analysed using techniques which are

flawed by design, in such a way that they exaggerate the benefits

of treatment’.

I said you should read it; I did not say that you would enjoy

what it had to say!

I have spent most of my working life working

in this industry. I have worked with, or for, most of the companies

in these pages. I found it uncomfortable reading.

The author is at pains to point out that the book is not about

’bad’ people. Rather, it is about ’good-hearted’ people working

in a system offering perverse rewards that inadvertently get in

the way of rational, evidence-based decision-making. A system

that extends beyond the industry to health service providers,

regulators, doctors, academics and politicians.

The chapter ’Where Do New Drugs Come From?’ provides a

brief overview of the drug discovery and development process

pitched at those outside the industry.

The chapter on ’Missing Data’ reviews the literature on publication

bias and the selective and distorted presentation of clinical

trials. In addition, to a familiar literature on sources of bias,

this chapter describes behaviour on the part of pharmaceutical

companies that can only be described as misguided, if not downright

obstructive, delaying or preventing systematic reviews of

trial data. Whatever the reasons, it does not look good.

Chapter Three on ’Bad Regulators’ describes the sociological

phenomenon of ’regulatory capture’ – the process by which a

regulator ends up promoting the interests of the industry it is supposed

tomonitor. Examples and data are presented documenting

the extent to which this has happened within the pharmaceutical

industry.

Chapter Four on ’Bad Trials’ catalogues all the usual potential

design problems besetting clinical trials: primary and secondary

endpoints, subgroups, early stopping, choice of comparators

and choice of dose. In truth, most of this is familiar ground to

statisticians in the pharmaceutical industry. What may come as

a surprise is the way in which devices to minimize heterogeneity

and obtain unbiased estimates of treatment effects can be

misinterpreted as attempts to overstate the benefits of drug treatments.

However, the review of the literature on the kinds of

patients recruited to clinical trials and how they differ from ’real’

patients is key to the next chapter – Chapter Five on ’Bigger,

Simpler Trials’.
Chapter Five argues persuasively for extended trials in the real

patient population to ensure the ecological validity of trials and

for early detection of safety issues. In truth, this is more radical

than it sounds requiring a paradigm shift away from a regulatory

pass/fail system to an evidence-based continuous improvement

process with risk sharing by the industry and society to make this

happen. I liked it.

However, it is in Chapter Six on ’Marketing’ that Goldacre truly

takes the pharmaceutical industry to task. In this chapter, he outlines

how marketing and promotional activities by pharmaceutical

companies distort attempts at evidence-based medicine. The

industry spends twice as much money on marketing and promotion

as it does on research and development. In truth, this is

on a par with many other sectors. And, for the most part, these

behaviours are perfectly legal and share much in common with

the marketing of other products in other industries. The issue

at stake is the influence they have on the selective presentation

of data. Goldacre points to the infiltration of everything from

patient groups and the continuing medical education subindustry

through to academic publishing. Again, the argument is not

that the individuals engaged in these practices are ’bad’. Just that

their influence is all-pervasive perverting data-driven decision making.

The final chapter on ’Better Data’ outlines the impact of these

behaviours on the pharmaceutical industry. The last few years

have seen the industry censured and received hefty fines for some

of these activities. Eli Lilly (US$1.4bn) for the off-label promotion

of olanzapine; Pfizer (US$2.3bn) for misleading promotion of the

painkiller Bextra; Merck ($US1.0bn) in 2011; Abbott (US$1.5bn) in

2012; and, most recently, GSK (US$3.0bn) in 2012. This really does

not look good.

The book ends with a call for Better Data. Chapter 7 develops

an action plan outlining the steps needed to change the current

system. Personally, this was one of the things I really liked

about the book. Rather than just whine about the current system,

Ben Goldacre presents plenty of ideas on how to fix it. Some of

them are good ideas – for example, outcome reporting deadlines

for clinical trials. Others I thought misguided – for example,

challenge your physician on their corporate hospitality record.

However, each chapter ends with a bulleted action plan. Better

Data provides an action plan for everyone – patients, trial participants,

patient groups, professional bodies, publishers, regulators

and those in the industry. Sure, I did not like every one of these

suggestions – for example, WikiLeaks style guerrilla action. However,

there is no doubt in my mind that these lists will stimulate

not just discussion but action.

Unlike other outspoken critics of the pharmaceutical industry,

Ben Goldacre combines both passion and a (largely) evidence

based, data-driven approach to the issues raised in the book.

Without this, it would be just another book carping about the

pharmaceutical industry. Instead, this book will be widely read

and, like it or not, have a profound impact on the industry.

Dennis Lendrem

University of Newcastle upon Tyne, UK

Pharmaceut. Statist. 2013, 12 186–187

http://onlinelibrary.wiley.com/doi/10.1002/pst.1562/epdf