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Lies, damn lies and drug trials

Bad Pharma: How drug companies mislead doctors and harm patients - review.

Bad Pharma: How drug companies mislead doctors and harm patients
Ben Goldacre
Fourth Estate, 448pp, £13.99

Ben Goldacre is angry. Not just about the sharp practice – and sometimes outright fraud – practiced by pharmaceutical companies as they develop and market drugs, but also about how difficult it is to get anyone interested in it. That’s not Goldacre’s fault: Bad Pharma is an engaging, polemic and elegant book, written with the lay reader in mind. It’s just that explaining the myriad ways in which the evidence base of medicine is distorted, and the effect that has on real people, will never fit in a slogan, a headline or a tweet.

In the first chapter, Goldacre sets out his stall. “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.”

Goldacre made his name with the Guardian’s “Bad Science” column but it’s been clear for a while that statistics are what really energise him. Most politicians and journalists notoriously find numbers baffling; very clever and influential people get away with epic innumeracy where a slight verbal stumble would be ruthlessly derided. Contrast the sniggering over David Cameron not knowing the translation of “Magna Carta” with the finding from the Royal Statistical Society that 77 per cent of Labour MPs could not correctly answer the question: “If you spin a coin twice, what is the probability of getting two heads?” (It’s 25 per cent, by the way.)

Doctors do at least have some training in appraising evidence but as Goldacre shows, there are so many ways you can skew a clinical trial that it’s unrealistic to expect a GP or consultant to spot any dodgy data. For example, you could recruit patients to your trial who have no other medical conditions or drug prescriptions, making them more likely to get better. You can test a drug against a sugar-pill placebo, instead of the best current competitor. You can stop a trial early if it looks like it’s going well, or prolong it in the hope that the results will even out. You can find a fluke “clump” of encouraging results about one minor symptom and pretend that’s what the trial was going to measure all along.

Running alongside all of these practices – for which the researchers involved must take some responsibility – is the simple fact that the whole architecture of research publication is tilted towards new, exciting and positive results. There is currently no requirement for the results of every trial to be made public, so naturally academics only want to bother when they’ve found something interesting. Journal editors also worry that research which discovers a treatment has no benefit, or replicates a previous study, is boring. This flatters the drugs and helps their manufacturers reap billions from them.

If all this sounds too crunchy, then some of Goldacre’s case studies will remind you why this stuff is important. Take the “Elephant Man” trial in 2006, where six volunteers were left with rotting toes and fingers, unable to breathe without assistance, because they were given a new drug called TGN1412, which had never been tested on humans before. An inquiry into the fiasco found that a medicine with a similar action in the body had been tried on a patient, years before. It had made that person very unwell, but – you guessed it – the research wasn’t published.

On a grander scale, GlaxoSmithKline concealed the fact that one of its anti-depressants, paroxetine, increased the risk of suicide among children. It managed this because the drug was officially only licensed for used in over-18s and because it mixed the safety data for children in with that of adults, diluting the apparent risk.

That case is not all that exceptional. The list of fines given to drug companies is stomach-turning: $1.4bn to Eli Lilly for wrongly promoting a schizophrenia drug; $2.3bn to Pfizer for pushing the painkiller Bextra, and so on. These huge sums explain the grand failure that lies behind the scandal of Bad Pharma: regulation. As in banking, the regulators struggled to operate across different jurisdictions, against multinational companies with far more money than them; as in Hackgate, they have been too cosy with the industry they are supposed to patrol.

But the real strength of Goldacre’s book is that he has answers. If poorly funded and easily swayed regulators can’t police the industry, then make the data available to everyone. Replace bewildering consent forms with shorter ones in plain English. Scrap the endless drug information labels that list every conceivable side effect (from heart attacks to bad breath) with simple checklists that show how common they are.

This is an important book. Ben Goldacre is angry, and by the time you put Bad Pharma down, you should be too.

Helen Lewis is deputy editor of the New Statesman. She has presented BBC Radio 4’s Week in Westminster and is a regular panellist on BBC1’s Sunday Politics.

This article first appeared in the 08 October 2012 issue of the New Statesman, Conservative conference special

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The Bloody Mary is dead: all hail the Bloody Caesar

This Canadian version of an old standard is a good substitute for dinner.

It is not anti-Catholic bias that makes me dislike the Bloody Mary, that lumpish combination of tomato juice and vodka named after a 16th-century English queen who, despite the immense reach of her royal powers, found burning Protestants alive the most effective display of majesty.

My prejudice is against its contents: the pulverised tomatoes that look like run-off from a Tudor torture chamber. A whole tomato is a source of joy and, occasionally, wonder (I remember learning that the Farsi for tomato is gojeh farangi, which translates literally as “foreign plum”) – and I am as fond of pizza as anyone. Most accessories to the Bloody Mary are fine with me: Worcestershire sauce, Tabasco, celery, black pepper, even sherry or oysters. But generally I share the curmudgeon Bernard DeVoto’s mistrust of fruit juice in my spirits: “all pestilential, all gangrenous, all vile” was the great man’s verdict. His main objection was sweetness but I will include the admittedly savoury tomato in my ban. At the cocktail hour, I have been known to crave all kinds of odd concoctions but none has included pulp.

To many, the whole point of a Bloody Mary is that you don’t wait until the cocktail hour. This seems to entail a certain shying away from unpleasant realities. I know perfectly well the reaction I would get if I were to ask for a grilled tomato and a chilled Martini at brunch: my friends would start likening me to F Scott Fitzgerald and they wouldn’t be referring to my writing talent. Despite its remarkably similar contents, a Bloody Mary is a perfectly acceptable midday, middle-class beverage. If the original Mary were here to witness such hypocrisy, she would surely tut and reach for her firelighters.

Yet, like the good Catholic I certainly am not, I must confess, for I have seen the error of my ways. In July, on Vancouver Island, I tried a Bloody Caesar – Canada’s spirited response to England’s favourite breakfast tipple (“I’ll see your Tudor queen, you bunch of retrograde royalists, and raise you a Roman emperor”). The main difference is a weird yet oddly palatable concoction called Clamato: tomato juice thinned and refined by clam juice. Replace your standard slop with this stuff, which has all the tang of tomato yet flows like a veritable Niagara, and you will have a drink far stranger yet more delicious than the traditional version.

Apparently, the Caesar was invented by an Italian restaurateur in Calgary, Alberta, who wanted a liquid version of his favourite dish from the old country: spaghetti alle vongole in rosso (clam and tomato spaghetti). He got it – and, more importantly, the rest of us got something we can drink not at breakfast but instead of dinner. Find a really interesting garnish – pickled bull kelp or spicy pickled celery, say – and you can even claim to have eaten your greens.

I’m sure that dedicated fans of the Bloody Mary will consider this entire column heretical, which seems appropriate: that’s the side I was born on, being Jewish, and I like to hope I wouldn’t switch even under extreme forms of persuasion. But this cocktail is in any case a broad church: few cocktails come in so many different incarnations.

The original was invented, according to him, by Fernand Petiot, who was a French barman in New York during Prohibition (and so must have known a thing or two about hypocrisy). It includes lemon juice and a “layer” of Worcestershire sauce and the tomato juice is strained; it may also actually have been named after a barmaid.

All of which proves only that dogma has no place at the bar. Variety is the spice of life, which makes it ironic that the world’s spiciest cocktail bestows a frivolous immortality on a woman who believed all choice to be the work of the devil.

Next week John Burnside on nature

Nina Caplan is the 2014 Fortnum & Mason Drink Writer of the Year and 2014 Louis Roederer International Wine Columnist of the Year for her columns on drink in the New Statesman. She tweets as @NinaCaplan.

This article first appeared in the 08 October 2015 issue of the New Statesman, Putin vs Isis