30August2014

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Bad Pharma, Bad Journalism

By David Cromwell

Ben Goldacre is a medical doctor and science writer who, until November 2011, wrote the Guardian’s Bad Science column which was presented as a thorn in the side of pseudoscience, quackery and ‘Big Pharma’, the giant and powerful pharmaceutical industry. On September 21, the Guardian published an extract, ‘The drugs don't work: a modern medical scandal’, from Goldacre's new book, Bad Pharma. (Unfortunately no longer available on the Guardian website. However, it can currently be accessed here). A disturbing picture emerges of corporate drug abuse:

'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 that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects.’

As an example, Goldacre cites detailed medical reviews of trials testing the benefits of statins, cholesterol-reducing drugs, taken to reduce the risk of heart attacks. In 2003, two such reviews were published. Both found that industry-funded trials were about four times more likely to report positive results. A further review in 2007 found twenty new studies in the intervening four years. All but two of them showed that industry-sponsored trials were more likely to report flattering results. In other words, industry-funded drug trials with negative results tend to be buried, glossed over or otherwise ignored.

Goldacre notes:

‘In any sensible world, when researchers are conducting trials on a new tablet for a drug company, for example, we'd expect [...] that all researchers are obliged to publish their results, and that industry sponsors – which have a huge interest in positive results – must have no control over the data. But, despite everything we know about industry-funded research being systematically biased, this does not happen. In fact, the opposite is true: it is entirely normal for researchers and academics conducting industry-funded trials to sign contracts subjecting them to gagging clauses that forbid them to publish, discuss or analyse data from their trials without the permission of the funder.’

As a further example, consider the giant pharmaceutical company GlaxoSmithKline which wanted to extend the market for the commonly used antidepressant paroxetine to children. Drugs that are licensed for use in adults are sometimes also prescribed for children. Clearly this represents a potential hazard with the risk of unknown side-effects. Regulators have tried to address this by offering inducements to companies to apply for formal authorisation for drug use in children. GSK therefore conducted a series of trials of paroxetine in children. However, at the end of the trials there was no clear benefit in treating depression. Rather than tell doctors and patients, or withdraw the drug, a secret internal company memo concluded: 'It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.’ In the year after this secret memo, 32,000 prescriptions were nonethless issued to children for paroxetine in the UK alone. So while the company knew the drug didn't work in children, it was in no hurry to tell doctors, despite knowing that large numbers of children were taking it.

Goldacre continues:

‘It gets much worse than that. These children weren't simply receiving a drug that the company knew to be ineffective for them; they were also being exposed to side-effects. This should be self-evident, since any effective treatment will have some side-effects, and doctors factor this in, alongside the benefits (which in this case were nonexistent). But nobody knew how bad these side-effects were, because the company didn't tell doctors, or patients, or even the regulator about the worrying safety data from its trials. This was because of a loophole: you have to tell the regulator only about side-effects reported in studies looking at the specific uses for which the drug has a marketing authorisation. Because the use of paroxetine in children was “off-label” [i.e., marketing authorisation had been granted for adults, but not specifically for children], GSK had no legal obligation to tell anyone about what it had found.’

And he concludes:

‘Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us.’

No reasonable person could fail to be troubled by Goldacre’s damning assessment of the drugs industry. But had he gone far enough? Economist Harry Shutt didn't think so. Shutt is a rare example of a professional economist who is also a radical critic of the current economic system. Since the 1970s, he has been a consultant for international development agencies including the UN and the World Bank. He has also written easily-digested books, such as The Trouble with Capitalism (Zed Books, 1998/2009) and The Decline of Capitalism (Zed Books, 2005), exposing the growing unsustainability of the status quo. In 2005, he warned presciently of 'an unavoidable financial crisis' on a greater scale than any before. Ever since the global crash of 2007-2008, he has argued that a return to enduring growth is neither desirable nor possible, and that western societies have to 'grasp the nettle' of a 'post-capitalist' economic future. His articulate thoughts on this can be found in his latest book, Beyond the Profits System (Zed Books, 2010).

 

Those Dirty Words: 'Public Ownership'

Shutt emailed Goldacre:

‘The blindingly obvious inference of the extract from your book published in the Guardian - as of so many others you once commendably wrote in your Bad Science column - is that this is an industry totally unsuited to being run on profit-maximising lines by conventional shareholder companies. Given that, and the tremendous level of subsidy the industry already receives from governments around the world, why not spell out the vital necessity of locating it within publicly owned/non-profit organisations where there need be no obstacle to full transparency?’

In an Observer interview, Goldacre responded to Shutt (as well as other readers who had submitted questions after publication of the book extract):

I am a realist about this. I don't want a central-command state economy. In general, drug companies are reasonably good at developing new treatments and there's also a lot of good in the industry. The point of my book is that it's possible for good people in badly designed systems to perpetrate acts of great evil completely unthinkingly. I don't think any of the people I write about would punch an old lady in the face, but they would inflict the same level of harm when they are abstracted away from the outcomes of their actions.

‘This is made easier, I think, because in general, most drugs do work better than nothing: it's just that we may be misled into using, for example, an expensive new drug where an older, cheaper one is more effective.

‘Overall, the problem is we don't have a competent regulatory framework that prevents things from going horribly wrong. If companies are allowed to hide the results of clinical trials then they will, and that will distort clinical practice. Doctors and patients will be misled and make sub-optimal decisions about what treatment is best for them.

‘Similarly, if you can get on to the market by making a me-too copycat drug that represents little or no therapeutic advance and is even less effective than the drugs that it copies, then you will. And you can get such a drug to the market because regulators approve new treatments even when they've only been shown only to be better than placebo.’

But this ducked the question that had been put to him, as Shutt pointed out in a follow-up email (October 9, 2012):

Dear Ben Goldacre

I was disappointed in your response to my question regarding the appropriateness of the profit-maximising model for the pharmaceutical industry and surprised at your implied suggestion that I must be advocating a centrally planned (Soviet-style?) economy.

You must be aware that many major industries in market economies are or have been state-owned without the countries concerned being identifiable as centrally planned. An obvious example is the rail industry, which is state-owned in nearly every European country and demonstrably performs more cost-effectively than its privatised UK counterpart, which (as pointed out in a recent Guardian article) the overwhelming majority of the British public has consistently favoured being renationalised (along with the water sector) without anyone inferring that those expressing this view must be card-carrying Communists. You must likewise know that a major British drug manufacturer - the Wellcome Foundation - was until 1986 a wholly owned subsidiary of a charitable trust, and that charitable and NHS institutions continue to provide vital funding for medical research here and around the world - to the considerable profit of Big Pharma.

In view of this and of your own work demonstrating the damaging consequences of profit-driven business models in terms of a) bad health outcomes and b) wasted public resources, I find your position rather baffling. Yet I am not so cynical as to suppose you might be motivated by a fear that reducing or eliminating perverse incentives to Big Pharma would tend to reduce the market for investigative journalism in the sector.

Best regards

Harry Shutt

Receiving no reply, Shutt emailed him again on October 15:

Dear Ben Goldacre

Further to my message of 9 October I have just noticed that in your response to some of the comments arising you repeat your assertion that you 'don't think it's common that medical interventions do more harm than good'. This statement seems an obvious and regrettable departure from your normal very proper insistence that findings and policy in the field of medical science should be evidence-based. May I also point out that the same principle is supposed to apply as far as possible in social sciences such as economics, although there practitioners are much more easily allowed to get away with claims - such as that 'cutting taxes stimulates growth' - for which there is no real evidential basis.

It is of course well known that bigotry is too readily passed off as science in any field according to whichever ideology or vested interest is dominant. It has been one of the great merits of your Bad Science column that you have consistently challenged this tendency in the field of medicine and diet. It is therefore all the more disappointing that you seem unwilling to maintain this rational stance when the evidence you have so commendably accumulated points to a conclusion which, although totally logical, may be viewed as too politically extreme by Big Pharma and other powerful commercial interests.

Given what is now at stake in the disintegrating global economy, leadership towards rational solutions to our problems from those such as yourself with established authority in their field has never been more needed. I hope you will not shrink from giving it through whatever medium you can.

I look forward to receiving your reply.

Best regards

Harry Shutt

Ben Goldacre has not replied to Harry Shutt’s follow-up emails.

 

Power, Profit And The Law

Meanwhile, the Guardian published a positive review of Goldacre's book by Luisa Dillner who works for the British Medical Journal. She concurred with his assessment of 'how the $600bn drug industry, doctors, academics, regulators and medical journals have let patients down.'

How will Big Pharma respond to Goldacre's book? Dillner speculates:

'Drug companies may say that the problems he identifies have now disappeared. New rules insist they register the details of trials, and publish the results – whether negative or positive. But as Goldacre points out, little has really changed, because no one checks up.'

Like Goldacre, Dillner hopes that better, tougher regulation will fix things, adding weakly:

'At the BMJ we are revising our declarations of interest form to say we will seek [our emphasis] to work with doctors who have not received financial hand-outs from drug companies...'

Making it clear she doesn't want to push things too far, she adds:

'But pharmaceutical companies are, after all, not charities. They exist to make and sell drugs, some of which work well, and to make a profit for their shareholders.'

Which begs the question: why not charities or public ownership, as suggested by Shutt? Dillner herself points out that doctors do not like admitting that they could ever be influenced by corporate ads and sponsorship, 'even though the evidence to the contrary is overwhelming.' And because they are not charities or publicly owned, and exist to make a private profit for shareholders, Big Pharma massively inflates the cost of developing new drugs. Companies claim that it costs £550m to bring a new drug to the market, but Goldacre cites evidence putting it at a quarter of that cost.

Nick Harvey reports in New Internationalist that:

'one-fifth of the world’s generic drugs – containing the same active ingredients as a patented drug but made by a different company at a fraction of the price – are made in India. As well as supplying India’s huge population, these drugs are shipped to poor countries around the world.'

Moreover, notes Harvey, the majority of global research and development funding is used to produce merely minor variations in existing drugs. This leads not only to high prices - indeed 'mammoth profits are generated by aggressive pricing' - but a dearth of genuinely new drugs.

Harvey adds:

'Countries are allowed by the World Trade Organization to produce generic drugs if there is a major public health imperative, a practice known as compulsory licensing. India issued its first compulsory licence in March, ordering German drugmaker Bayer to allow a generic manufacturer to make its cancer drug Nexavar (sorafenib) for one-thirtieth of the usual $5,000 price tag. India’s patent controller argued that not only had Bayer failed to make the drug "reasonably affordable", it had failed to supply the drug in large enough quantities, a decision Bayer is challenging in the courts.'

Novartis, another large drugs company, is also mounting a legal challenge in India to enable it to continue patenting 'new' drugs that are little different from existing drugs.

Big Pharma is abusing its power to attack a legal framework that allows generic drug production to benefit people, particular in poor countries. So again - why not charities or public ownership?

 

Who's Living In Cloud-Cuckoo Land?

In an astute piece on Goldacre’s published response to Shutt's first email, titled ‘Bad Pharma meets the Good Regulation Fairy’, one commentator started off by quoting the Slovenian cultural critic Slavoj Žižek:

‘It’s easier to imagine the end of the world than the end of capitalism.’

Goldacre’s evasive answer to Shutt illustrated that point. The author of the piece, a freelance journalist who maintains anonymity on his blog, rightly noted that Goldacre, in raising the spectre of a Soviet-style ‘central command economy’, was dismissive of Shutt’s perfectly reasonable challenge. Goldacre's riposte was ‘a very jaded straw man and definitely not what Shutt was advocating.’

The journalist continued:

‘This was followed, most bizarrely, by the assertion that people in the drugs industry perpetuate acts of great evil, not because they are innately evil, but because they work in a badly designed system. This is precisely what Shutt was saying – it’s a badly designed system, its acts are not the “fault” of the individuals working in it, so change the system. As an answer, that lacks something. It’s like saying 2+3 isn’t 5, it’s 5.’

Goldacre’s ineffectual rebuttal of Shutt's challenge boiled down to the good regulation fairy of a ‘competent regulatory framework’ to fend off rampant global capitalism. This displays a curious ideological faith in an inequitable system; curious, because it comes from a science writer and doctor who prides himself – usually with justification - on reliance on hard evidence and clear analysis.

The journalist then asks us to imagine the reaction if the state had been guilty of flooding hospitals, clinics and GP surgeries with dangerous or dysfunctional drugs. There would, of course, have been howls of outrage followed immediately by urgent and deafening demands for the privatisation of pharmaceuticals. That critics of the cynical, profit-driven and abusive practices of corporate drug companies call merely for better regulation provides a crucial insight into the dangerous imbalance of power in society. In his naive and faith-based appeal for a ‘competent regulatory framework’, Goldacre has overlooked the fundamental problem that western ‘democratic’ political systems are utterly dominated and skewed by destructive, profit-driven corporate priorities.

Given the failure of Goldacre’s imagination, the journalist suggests a thought experiment. Consider ‘an ideal world where the state sits benevolently above the fray and government regulation can do its job unimpeded. What would regulation actually do?’

'...competent and effective regulation will, if it does anything, radically reduce the number of pharmaceuticals that are allowed to go on the market. Thereby massively hitting drug company profits (they are currently the darlings of stock markets worldwide because they are so profitable) and, in turn, the number of people they employ.

‘Thus, you are soon face to face with a fundamental conflict of our capitalist system. An unavoidable collision between the impulse most decent people share for reducing the anti-social effects of capitalism, against the need for capitalism to prosper so that everyone can have good jobs and incomes. We are, whether we like it or not, materially dependent on the system’s success. But a successful system causes results, such as global warming and prescribing dangerous medicines, that are inherently destructive.’

He sums up cogently:

‘If regulation of the pharmaceutical industry were actually competent, as Goldacre wants it to be, it would prevent capitalism from working (actually it’s not working well anyway but effective regulation would be another drag on profits). A 2009 UN report found that a third of the profits of the world’s biggest 3,000 companies would be wiped out if firms were forced to pay for the use, loss and damage to the environment they cause. In other words, truly effective environmental regulation would render capitalism impossible.

‘So regulation is, quite deliberately, not effective. It allows, as research has found, just enough reform to buy off critics without seriously impeding corporate priorities. In the end, Goldacre’s vision of a “competent regulatory framework” is far more utopian than changing the system so that profit maximization is not the modus operandi of pharmaceutical companies.’

This is a devastating conclusion: it’s the would-be reformers who are living in cloud-cuckoo land. The same applies to other ‘mainstream’ journalists, activists and writers, on any number of topics, who are propping up the present unjust, unstable and planet-devouring system of global capitalism by calling merely for ‘better regulation’. Anything more challenging than this is well off the corporate media agenda. It is even off the agenda of the bulk of the green movement, trade unions, human rights groups and other major nongovernmental organisations that we are supposed to believe are challenging the status quo.

 

Cut To The Chase

As mentioned earlier, Ben Goldacre has still not responded to economist Harry Shutt’s polite and rational follow-up emails. Perhaps he realises the simple points made by Shutt are unassailable. This is not unusual in our experience. Challenging those with a platform in the corporate media about its failure – indeed, its systemic inability – to question the very framework of corporate capitalism in which it is embedded is routinely met with silence, evasions or even condescending brush-offs. Media Lens has seen them all, whether from The Guardian, The Independent, The Sunday Times or the Financial Times

Indeed, it was the Sunday Times economics editor who declared dismissively from his Murdoch-funded position that:

‘Most of us get these things out of our system when we are students.’

Well, undoubtedly he did; and perhaps with some residual feelings of regret or even guilt.

When the documentary film-maker Michael Moore was asked why he made his 2009 film, Capitalism: A Love Story, he responded:

‘Well, I’ve been making movies for about twenty years now. Actually, it’s twenty years ago this week Roger & Me was at the New York Film Festival. And the films I’ve done, from that one all the way through Sicko, always seem to come back to this central core concern, which is the economic system we have is unfair, it’s unjust, it’s not democratic, it seems to lack any sort of ethical center to it. And I guess I can keep making movies for another twenty years about the next General Motors or the next healthcare issue or whatever, but I thought I’d just kind of cut to the chase and propose that we deal with this economic system and try to restructure it in a way that benefits people and not the richest one percent.’

Our battle, then, is not for ‘reform’ or better ‘regulatory frameworks’ applied to a fundamentally unjust and undemocratic state of affairs. It’s about restructuring the economic system so that it benefits everyone and not just the rich few.

 

SUGGESTED ACTION

The goal of Media Lens is to promote rationality, compassion and respect for others. If you do write to journalists, we strongly urge you to maintain a polite, non-aggressive and non-abusive tone.

Write to Ben Goldacre, Bad Science website. 

Email: ben@badscience.net

Twitter: @bengoldacre

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