“Drugs are tested by the people who manufacture them, in poorly designed trials, on hoplessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments,” he writes. “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.”
The Association of the British Pharmaceutical Industry's CEO, Stephen Whitehead, got in touch to give his response to Goldacre's accusations; his letter is printed below. Goldacre provided a reply to Whitehead's letter, which is also reproduced.
Letter from the ABPI
The points raised in Helen Lewis’ review of Ben Goldacre’s book Bad Pharma ("Lies, damn lies and drug trials") do not present an accurate picture of the pharmaceutical industry in the UK as it is today.
Mr Goldacre, as a health-care professional, no doubt understands the industry but seems to be stuck in a bygone era where pharmaceutical companies wine and dine doctors in exchange for signing on the dotted line. Similarly, references to companies (GSK, Lilly, Pfizer) being fined are all examples from the US and simply not relevant to the UK market.
Let us not forget that the pharmaceutical industry has been responsible for the development of 90 per cent of medicines in the world and through incremental innovation, has helped the management of many illnesses (some previously terminal) to improve no end.
Goldacre claims that “drugs are tested . . . using techniques that are flawed by design”, when in fact medicines are tested against the most effective comparator where possible unless there is no current standard of care. In these instances placebo studies must be undertaken.
The undertaking of clinical trials is tightly regulated in the UK by the MHRA and the EMA across Europe, who scrutinise clinical trial data relating to the quality, efficacy and safety of new medicines – everything is done to ensure that ineffective treatments do not reach patients.
Contrary to Goldacre’s musings, we do not seek to “hide” trial data – it is already best practice within industry to publish all data, positive and negative. We recognise that there still work to be done in ensuring the publication of negative trial data within journals, and in ensuring greater transparency all round within the industry, but we are working collaboratively with the wider health-care sector to achieve this and will continue to do so to bring about improved outcomes in patient care.
CEO of the Association of the British Pharmaceutical Industry
Reply from Ben Goldacre
Dear New Statesman,
I see that Stephen Whitehead from the Association of the British Pharmaceutical Industry has written in response to your review of my book Bad Pharma. He makes a series of false claims, on important matters of patient safety.
He says that the $3bn criminal fine levied against GSK in the US is irrelevant to the UK. This is untrue. As I explain in the book: GSK is a UK company. The US court gave examples of media stories generated by GSK to promote drugs illegally: these came from the Sun, the Guardian, the Times, and the Mail, which are all UK newspapers. GSK staff named in the US ruling continued to work at GSK; two now head major European drug companies. Richard Sykes was the chair of GSK during the period covered by the criminal fraud findings: he is now chair of Imperial College NHS Trust and also chair of the Royal Institution.
It is, therefore, bizarre to claim that GSK’s acts of criminal and civil fraud are not relevant to the UK market. Hidden trial data and illegal promotion of drugs is an international problem and these fines very clearly relate to activity in the UK.
Mr Whitehead goes on to make further false claims about how new drugs are tested, saying “medicines are tested against the most effective comparator where possible unless there is no current standard of care”.
This, again, is very simply untrue. As I explain in the book, a 2011 study looked at all drugs approved by the FDA between 2000 and 2010 and found that a third had been tested only against placebo, even when there was a currently available effective treatment, which they could and should have been compared against. As a result of this practice, doctors and patients are deprived of valuable information. The study was published in JAMA, one of the top three medical journals in the world, and can be read for free online.
I could go on. There are serious ongoing problems in the pharmaceutical industry, which rushed journalists have sadly neglected. Doctors and patients need the results of all clinical trials, to make informed decisions about the risks and benefits of treatments. Companies continue to withhold this information, with the complicity of medicines regulators and NICE, as I document in my book. This is a global scandal that puts patients at risk.
There are many people working in the pharmaceutical industry with high moral standards, who recognise that this kind of ongoing unethical activity must be urgently addressed, and who are keen to engage constructively with doctors and academics. The industry as a whole may wish to consider whether the outright denials and demonstrably false claims of Stephen Whitehead are going to serve them well.
Dr Ben Goldacre