Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (35 page)

This is a new phenomenon, but it has become so widespread that American celebrity shows are now having to screen for endorsements before interview segments go ahead. CBS, for example, recently reported that an interview with Rob Lowe – of all people – was dropped by NBC because of concerns about him promoting a drug for people on chemotherapy.
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So when PR News gushingly reports that a character on
ER
with Alzheimer’s disease was treated with the new drug Aricept thanks to the work of a PR firm working for Pfizer, it comes as no surprise.
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The TV spots where sponsorship is openly declared are often much more bizarre: although it’s only directed at the US market, for a flavour of how this world works, I strongly encourage UK readers to find Barry Manilow’s ‘Get Back in Rhythm’ video online, promoting a drug that treats abnormal heart rhythms (‘Hi, this is Barry Manilow, and that’s the
rhythm
to my song “Copacabana”…’). Jon Bon Jovi’s painkiller advert is even slicker. And Antonio Banderas is the voice of a bee for Merck’s Nasonex.

But sometimes the hidden hand can be more subtle. You will remember, I’m sure, the media stories around Herceptin, a drug which has a very modest effect on survival for some kinds of breast cancer, at a cost of serious cardiac side effects, and tens of thousands of pounds for each treatment. From 2005, access to this drug became a spontaneous
cause célèbre
for the British press, and the extent of the distortion is best expressed in the words of one GP who was suffering from breast cancer herself, and later wrote of being caught up in the bombardment of media coverage: ‘I began to feel that if I did not receive this drug then I would have very little chance of surviving my cancer.’ When she stepped back from the maelstrom and looked at the data as it stood at the time, she was surprised: ‘More careful analysis of the “50 per cent benefit” which had been widely quoted in the medical and non-medical press, and fixed in my mind, actually translated into a 4–5 per cent benefit to me, which equally balanced the cardiac risk…This story illustrates how even a medically trained and usually rational woman becomes vulnerable when diagnosed as having a potentially life-threatening illness.’
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The dominant theme of this media coverage was that NICE should approve Herceptin for use on the NHS. Yet, bizarrely, the campaign was orchestrated before any evidence had even been given to NICE. The health minister, similarly, said the drug should be approved, but again before the data on its effectiveness was available.

What can explain all this? One group of academics tracked down every single newspaper story on Herceptin, to try to understand what had happened.
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They found 361 articles in total: the overwhelming majority (four out of five) were positive about the drug’s efficacy, and the remainder were neutral, with none negative. Side effects were mentioned in less than one in ten articles, and were often played down as minimal. Some articles came right out, in the face of all common sense, and declared that this miracle cancer drug had no side effects at all.

Half of the stories were about the problems in getting a licence for Herceptin’s use in early-stage breast cancer, but they almost never mentioned that the manufacturer, Roche, needed to apply for that licence itself, and hadn’t even done so yet. Many of them attacked NICE, but they hardly ever mentioned that it couldn’t even look at the drug for this use until it was licensed, and until the government asked it to.

Perhaps most remarkable was the use of individual patients, in two thirds of all the articles. Although journalists chose not to mention how they had found these women, in reality they were being provided to the media by lawyers and PR firms. Elaine Barber and Anne Marie Rogers each appeared in dozens of articles: they were handled by Irwin & Mitchell, which was shortlisted for a Chartered Institute of Public Relations award for its work on this project. Lisa Jardine, Professor of Renaissance Studies at Queen Mary, University of London, who was suffering from breast cancer, told the
Guardian
she was contacted by a PR firm working directly for Roche.
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The charity CancerBackup also appeared in these stories repeatedly, often hawking a survey finding which had been delivered to it by Roche, which also funded the charity’s work.
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Why would the involvement of a PR firm working for the drug company not be declared up front? Here’s an unusually open explanation. In 2010 the British government proposed a scheme allowing pharmacists to substitute all prescriptions for branded medicines with the generic alternative. Generic drugs, as you now know, are identical copies of a molecule, but manufactured more cheaply by another company when the original inventor’s exclusive patent has run out. Doctors who have been influenced by advertising from drug companies often write the brand name of the drug on the prescription, rather than the true scientific name. This proposed new law would allow pharmacists to ignore the brand name and substitute an identical generic copy of the drug, made by whichever company sold it most cheaply, potentially saving the NHS huge amounts of money, at no risk to patients. A letter of protest immediately appeared in
The Times
, signed by various patient groups and experts, and received positive coverage elsewhere in the broad-sheets. ‘Plan to Switch to Cheaper Medicines will Harm Patients, Say Experts’, reported
The Times
. It even had a case study: ‘Patient Given Seroxat Substitute Felt Unwell Within Two Days’. But Margaret McCartney, a GP who writes for the
British Medical Journal
, found out that the letter was coordinated and written by PR company Burson-Marsteller, paid for by the drug company Norgine. Peter Martin, chief operating officer of Norgine, was the major influence behind the campaign, but he did not sign the letter himself. Asked why not, he cheerfully replied, ‘There was no conspiracy. The frank truth, the honest truth, is that I thought that having a pharmaceutical company in there would sully the message somewhat.’

Despite that story, we shouldn’t allow ourselves to become too obsessed with conspiracies. Cancer and health are – as I’ve written endlessly outside this book – areas where many newspaper journalists distort facts as a matter of casual routine, without any commercial assistance, partly through a lack of knowledge, but also, I suspect, through a desire to be crusaders. We have already seen how figures can be reported misleadingly, in the coverage of the Jupiter trial on statins. But the simple tradition of using human stories, even when they do not represent the reality of the evidence, provides an open goal to companies, hoping that their drug will get positive coverage. In 2010, for example, the British media was filled with journalists angry about NICE’s recommendation not to fund Avastin, a bowel-cancer drug that costs £21,000 per patient. Overall, on average, when added to all the other treatments, the drug had been shown to increase survival by just six weeks, from 19.9 months to 21.3 months. But the newspaper stories featured Barbara Moss, who paid out of her own pocket to have Avastin in 2006, and was still alive four years later.
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I am pleased for her, but someone who has survived four years is no illustration whatsoever of what happens if you take Avastin for bowel cancer. You could find patients who survived for four years without Avastin too, and neither they nor Barbara Moss tell you anything informative whatsoever about the drug’s effectiveness.

Individual stories such as these are the bread and butter of health journalism. But beyond the desire to report on individual ‘miracle cures’, there is also a murkier problem. Journalists, like all of us, like to explain the world around them. Sometimes, though, a deceptively simple explanation for a complex phenomenon can be very powerful: it can prime the reader to accept a specific treatment, but it can also change our whole cultural understanding of a disease.

More than molecules

The idea that depression is caused by low serotonin levels in the brain is now deeply embedded in popular folklore, and people with no neuroscience background at all will routinely incorporate phrases about it into everyday discussion of their mood, just to keep their serotonin levels up. Many people also ‘know’ that this is how antidepressant drugs work: depression is caused by low serotonin, so you need drugs which raise the serotonin levels in your brain, like SSRI antidepressants, which are ‘selective serotonin reuptake inhibitors’. But this theory is wrong. The ‘serotonin hypothesis’ for depression, as it is known, was always shaky, and the evidence now is hugely contradictory.
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I’m not giving that lecture here, but as one brief illustration, there’s a drug called tianeptine – it is a selective serotonin reuptake enhancer, not an inhibitor, that should reduce serotonin levels – and yet research shows that it is also a pretty effective treatment for depression.

But in popular culture the depression–serotonin theory is proven and absolute, because it has been marketed so effectively. In drug adverts and educational material you can see it recycled, simply and plainly, because it makes absolute sense: depression is caused by too little serotonin, therefore our pill, which raises serotonin levels, will fix it. This uncomplicated notion is attractive, even though it has little support in academia, perhaps because it speaks to us of controllable, external, molecular pressures. As one US newspaper said recently about depression: ‘It’s not a personal deficit, but something that needs to be looked at as a chemical imbalance.’
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This is not a belief that arose spontaneously out of nowhere: it has been carefully fostered and maintained.
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A recent advert for paroxetine by GSK says: ‘If you’ve experienced some of these symptoms of depression nearly every day, for at least two weeks, a chemical imbalance could be to blame.’
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Or a patient’s guide to Pfizer’s SSRI: ‘Zoloft may help correct the chemical imbalance of serotonin in the brain.’ The same claims are found in adverts around the world, directed not only at adult patients, but also at children. One museum exhibition on the human brain sponsored by Pfizer started at the Smithsonian Institution in Washington and then toured the US. Half of us will experience ‘brain dysfunction’ at some stage in our lives, it happily explains: ‘Chemical imbalances in the brain – often involving the neurotransmitter serotonin – are almost certainly involved.’
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In 2008, two academics from the US wrote a remarkable paper, describing what happened when they contacted the journalists who were disseminating this idea, to find out if they could justify their claims.
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In return they were either ignored, fobbed off, or sent irrelevant academic papers that said nothing about serotonin and depression: ‘The quote was attributed to a psychiatric nurse practitioner,’ said one vignette. ‘The author did not respond to emails, and the nurse’s email was not available.’

One
New York Times
piece discussed a founder of the chemical theory of depression: ‘A groundbreaking paper that he published in 1965 suggested that naturally-occurring chemical imbalances in the brain must account for mood swings, which pharmaceuticals could correct, a hypothesis that proved to be right.’ When the academics gave chase, ‘Emails to [the journalist] requesting a citation to support his statement went unanswered.’ An article in
The Times
, titled ‘On the Horizon, Personalized Depression Drugs’, quoted a professor saying: ‘Some depressed patients who have abnormally low levels of serotonin respond to SSRIs, which relieve depression, in part, by flooding the brain with serotonin.’ In evidence, the journalist supplied an academic paper on a completely different subject.

The story of the serotonin hypothesis for depression, and its enthusiastic promotion by drug companies, is part of a wider process that has been called ‘disease-mongering’ or ‘medicalisation’, where diagnostic categories are widened, whole new diagnoses are invented, and normal variants of human experience are pathologised, so they can be treated with pills. One simple illustration of this is the recent spread of ‘checklists’ enabling the public to diagnose, or help diagnose, various medical conditions. In 2010, for example, the popular website WebMD launched a new test: ‘Rate your risk for depression: could you be depressed?’ It was funded by Eli Lilly, manufacturers of the anti-depressant duloxetine, and this was duly declared on the page, though that doesn’t reduce the absurdity of what followed.

The test consisted of ten questions, such as: ‘I feel sad or down most of the time’; ‘I feel tired almost every day’; ‘I have trouble concentrating’; ‘I feel worthless or hopeless’; ‘I find myself thinking a lot about dying’; and so on. If you answered ‘no’ to every single one of these questions – every single one – and then pressed ‘Submit’, the response was clear: ‘You may be at risk for major depression’.
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Lower Risk:

You may be at risk for major depression.

    * If you have recurring thoughts of death or suicide, call your doctor or any qualified health care provider right away. If you need immediate assistance or think you may have a medical emergency, call 911.

    You replied that you are feeling four or fewer of the common symptoms of depression. In general, people experiencing depression have five or more common symptoms of the condition. But every individual is unique. If you are concerned about depression, talk with your doctor.

This is not a meaningful diagnostic tool in any sense of the word. It is not raising awareness, or helping avoid underdiagnosis: it is marketing material, masquerading as patient information, and in my view it does clear harm, because it encourages people to diagnose themselves with problems they don’t have, and ultimately to seek out drugs that they are unlikely to benefit from. But this is common practice: through checklists on depression, social anxiety disorder, premenstrual dysphoric disorder and more, companies can turn people with discomfort into consumers with an intention to obtain their product.
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