Ben Goldacre’s Bad Pharma (2012) offered this critique of the $600bn global pharmaceutical industry:
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 treatments… When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients… academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure.
It is not ‘a cartoonish story of evil’ Goldacre is interested in describing, but one in which real people overlook the flawed processes by which a drug arrives in hand:
Drug companies are not withholding the secret to curing cancer, nor are they killing us all with vaccines… [But] it’s possible for good people, in perversely designed systems, to casually perpetrate acts of great harm on strangers, sometimes without ever realising it.
The selective publication of drug trial results is perhaps the most obvious issue. Separate studies have investigated the selective publication of antidepressant and antipsychotic trials. More general research has also been conducted.
The linked cluster of papers on unpublished evidence… confirm the fact that a large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately. We are not dealing here with trial design, hidden bias, or problems of data analysis—we are talking simply about the absence of the data.
The current best estimate is that half of all the clinical trials that have been conducted and completed have never been published in academic journals, and trials with positive results are twice as likely to be published as others.
Hidden clinical trial data are systematically undermining doctors’ abilities to prescribe treatment with confidence. A whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people’s lives and wasting public money.
The AllTrials campaign was launched in response in 2013; the group’s slogan is ‘All trials registered, all results reported’. The campaign attracted attention:
We were surprised and concerned to discover that information is routinely withheld from doctors and researchers about the methods and results of clinical trials on treatments currently prescribed in the United Kingdom. This problem has been noted for many years in the professional academic literature, with many promises given, but without adequate action being taken by government, industry or professional bodies. This now presents a serious problem because the medicines in use today came on to the market—and were therefore researched—over the preceding decades.
The motives behind the selective publication of trial results, as well as other kinds of systemic bias, ultimately derive from financial interest:
Although the industry’s vast network of public relations departments and trade associations generate a large volume of stories about the so called innovation crisis, the key role of blockbuster drugs, and the crisis created by ‘the patent cliff,’ the hidden business model of pharmaceuticals centres on turning out scores of minor variations, some of which become market blockbusters.
Companies are delighted when research breakthroughs occur, but they do not depend on them. Since the mid-1990s, independent reviews have concluded that about 85-90% of all new drugs provide few or no clinical advantages for patients:
How have we reached a situation where so much appears to be spent on research and development, yet only about 1 in 10 newly approved medicines substantially benefits patients? The low bars of being better than placebo, using surrogate endpoints instead of hard clinical outcomes, or being non-inferior to a comparator, allow approval of medicines that may even be less effective or less safe than existing ones.
The shortcomings of pharmaceuticals have become well-known and steps have been taken.
But instead of waiting for politicians to make laws, you should recognise that while drugs can be life-saving, poorly tested drugs have also produced an epidemic of adverse reactions.
Caution advised when dealing with BAD PHARMA.