---
title: "Bad Pharma"
chunk: 2/4
source: "https://en.wikipedia.org/wiki/Bad_Pharma"
category: "reference"
tags: "science, encyclopedia"
date_saved: "2026-05-05T03:30:59.709251+00:00"
instance: "kb-cron"
---

=== Chapter 2: "Where Do New Drugs Come From?" ===
In the second chapter, the book describes the process as new drugs move from animal testing through phase 1 (first-in-man study), phase 2, and phase 3 clinical trials. Phase 1 participants are referred to as volunteers, but in the US are paid $200–$400 per day, and because studies can last several weeks and subjects may volunteer several times a year, earning potential becomes the main reason for participation. Participants are usually taken from the poorest groups in society, and outsourcing increasingly means that trials may be conducted in countries with low wages by contract research organizations (CROs). The rate of growth for clinical trials in India is 20 percent a year, in Argentina 27 percent, and in China 47 percent, while trials in the UK have fallen by 10 percent a year and in the US by six percent.
The shift to outsourcing raises issues about data integrity, regulatory oversight, language difficulties, the meaning of informed consent among a much poorer population, the standards of clinical care, the extent to which corruption may be regarded as routine in certain countries, and the ethical problem of raising a population's expectations for drugs that most of that population cannot afford. It also raises the question of whether the results of clinical trials using one population can invariably be applied elsewhere. There are both social and physical differences: Goldacre asks whether patients diagnosed with depression in China are really the same as patients diagnosed with depression in California, and notes that people of Asian descent metabolize drugs differently from Westerners.
There have also been cases of available treatment being withheld during clinical trials. In 1996 in Kano, Nigeria, the drug company Pfizer compared a new antibiotic during a meningitis outbreak to a competing antibiotic that was known to be effective at a higher dose than was used during the trial. Goldacre writes that 11 children died, divided almost equally between the two groups. The families taking part in the trial were apparently not told that the competing antibiotic at the effective dose was available from Médecins Sans Frontières in the next-door building.

=== Chapter 3: "Bad Regulators" ===
Chapter three describes the concept of "regulatory capture," whereby a regulator – such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, or the Food and Drug Administration (FDA) in the United States – ends up advancing the interests of the drug companies rather than the interests of the public. Goldacre writes that this happens for a number of reasons, including the revolving door of employees between the regulator and the companies, and the fact that friendships develop between regulator and company employees simply because they have knowledge and interests in common. The chapter also discusses surrogate outcomes and accelerated approval, and the difficulty of having ineffective drugs removed from the market once they have been approved. He argues that regulators do not require that new drugs offer an improvement over what is already available, or even that they be particularly effective.

=== Chapter 4: "Bad Trials" ===
"Bad Trials" examines the ways in which clinical trials can be flawed. Goldacre writes that this happens by design and by analysis, and that it has the effect of maximizing a drug's benefits and minimizing harm.
There have been instances of fraud, though he says these are rare. More common are what he calls the "wily tricks, close calls, and elegant mischief at the margins of acceptability."
These include testing drugs on unrepresentative, "freakishly ideal" patients; comparing new drugs to something known to be ineffective, or effective at a different dose or if used differently; conducting trials that are too short or too small; and stopping trials early or late. It also includes measuring uninformative outcomes; packaging the data so that it is misleading; ignoring patients who drop out (i.e. using per-protocol analysis, where only patients who complete the trial are counted in the final results, rather than intention-to-treat analysis, where everyone who starts the trial is counted); changing the main outcome of the trial once it has finished; producing subgroup analyses that show apparently positive outcomes for certain tightly defined groups (such as Chinese men between the ages of 56 and 71), thereby hiding an overall negative outcome; and conducting "seeding trials," where the objective is to persuade physicians to use the drug.
Another criticism is that outcomes are presented in terms of relative risk reduction to exaggerate the apparent benefits of the treatment. For example, he writes, if four people out of 1,000 will have a heart attack within the year, but on statins only two will, that is a 50 percent reduction if expressed as relative risk reduction. But if expressed as absolute risk reduction, it is a reduction of just 0.2 percent.

=== Chapter 5: "Bigger, Simpler Trials" ===
In chapter five Goldacre suggests using the General Practice Research Database in the UK, which contains the anonymized records of several million patients, to conduct randomized trials to determine the most effective of competing treatments. For example, to compare two statins, atorvastatin and simvastatin, doctors would randomly assign patients to one or the other. The patients would be followed up by having data about their cholesterol levels, heart attacks, strokes and deaths taken from their computerized medical records. The trials would not be blind – patients would know which statin they had been prescribed – but Goldacre writes that they would be unlikely to hold such firm beliefs about which one is preferable to the extent that it could affect their health.