Article reference: http://www.laleva.org/eng/2006/11/drugs_r_us.html

Drugs 'R' us

The Sunday Times
November 12, 2006

Depression is a growing problem in children — and it is now legal for British doctors to give Prozac to eight-year-olds. So will more parents be tempted to use pills to make their children happy? John Cornwell investigates.

The alarm calls started ahead of the new school year. A strident chorus of doctors, politicians, religious leaders and child-interest groups is claiming that too many of our kids are stressed, dysfunctional and suffering from mental illness. Tony Blair and the Archbishop of Canterbury have focused on inadequate child rearing, such as the poor parenting skills of teenage single mums; David Cameron blames lack of common-or-garden physical affection.

And while leading psychiatrists, such as Ian Goodyer of Cambridge University, continue to cite traditional culprits – marriage break-up and domestic discord – a constituency of 100 childhood experts, led by the neuroscientist Baroness Susan Greenfield, is castigating unprecedented pressures at home and at school – from TV advertising to government-legislated school tests, from lack of imaginative reading matter to the tyranny of middle-class parental ambition. “Children,” says Greenfield, “are being pushed beyond their limits.”

In a new book, The Price of Privilege, the American psychologist Madeline Levine claims that affluent children, with parents earning more than £63,000 a year, have “three times the rate of depression and anxiety disorders as ordinary teenagers, as well as substantially higher rates of substance abuse, cutting and suicide”.

Research on middle-class childhood pressures lags behind in the UK, but the popular psychologist Oliver James, who is set to publish in January a new book, Affluenza, about the mental cost of wealth, warns that it is not affluence alone that “translates into greater happiness or mental health”, but the quality of early parental care.

Pleas for action have come thick and fast: early intervention in the case of dysfunctional families, counsels Tony Blair – before birth, if necessary; hug a hoodie, advocates Cameron; more free time for children to dream, recommends Greenfield. But a stark proposal, likely to impact on the children of the affluent more than the economically deprived, is now on offer: let them take Prozac.

This summer, the influential European Medicines Agency (EMEA) officially advocated the prescription of the antidepressant Prozac within the EU for children from the age of eight upwards, reinforcing a similar recommendation made last year by the UK’s Nice (the National Institute for Health and Clinical Excellence), despite the known dangerous side effects of the drug on children and adolescents.

The nub of the medical authorities’ argument is that there are mental conditions that only Prozac or Prozac-type drugs can reach. Prozac (or fluoxetine) came off patent five years ago, prompting the manufacture of a number of generic drugs of essentially the same chemical compound. As for the side effects, which include the risk of suicide, everything depends, the medical authorities advise, on the circumstances and care with which the Prozac-type drug is prescribed and monitored.

The EMEA and Nice have insisted that treatment with fluoxetine should be preceded and attended by psychotherapy. But Sane, the mental-health charity, and YoungMinds, the childhood mental-illness watchdog, are concerned about the lack of adequate resources in the National Health Service for the provision of psychotherapy for children.

Nor is there legislation in place that prevents doctors from prescribing fluoxetine to children without the recommended safeguards. There is ample evidence that some doctors have been prescribing the drug “off licence” to toddlers – in other words, they are doling them out outside of recommended usage, as an antidote to infant “agitation”. A study made by a pharmacology unit at Southampton University recently surveyed a small sample of 100 general practices in the UK, and found that 19 children – whose ages range from 1 to 12 – were on fluoxetine.

Against the background of the huge increase in the use of the amphetamine-like drug Ritalin for attention-deficit hyperactive disorder (ADHD), especially for middle-class children, there are fears, says Professor David Healey of the University of North Wales, that Prozac could follow a similar pattern of rapidly expanding usage as a quick fix for children deemed to be “low” or depressed. “Companies have been enabled to medicalise childhood distress, and as the rapidly changing culture surrounding the management of such problems indicates, companies have the power to change cultures and to do so in astonishingly short periods of time.” According to Department of Health (DoH) figures, the past 10 years have seen a tenfold increase in prescriptions for Ritalin in Britain to combat a range of perceived childhood and adolescent problems – from restlessness to lack of concentration in class.

According to the DoH, an estimated 30,000-40,000 children and teenagers are already being prescribed antidepressants in Britain (off licence in the case of pre-puberty children), and about half of those are treated with fluoxetine or Prozac. In total, the UK Prescription Pricing Authority reports a rise in courses of Prozac-type drugs from 3.7m in 2000 to 4.4m last year. No figures are as yet available for 2006 following the recommendation of Nice, and the authority offers no breakdown for prescriptions for children anyway. But prescriptions for children are clearly set to rise despite serious doubts about fluoxetine that have persisted ever since the drug first reached our pharmacies in the mid-1980s.

The debate over all antidepressants and children has been especially fierce in the US, where a federal panel of drug experts last year found a proven link between antidepressants and suicide in children and teenagers. The risk, according to the US Food and Drug Administration (FDA), is high when the course of treatment starts, or when there is a change of dosage, or sudden withdrawal. Last year an American teenager, Jeff Weise, shot dead nine men, women and children before committing suicide at Red Lake high school, Minnesota. His aunt Tammy Lussier told journalists that he first attempted suicide after he went on Prozac. After that, he was taking increased dosages, she said: “I can’t help but think it was too much, that it must have set him off.”

Fluoxetine is a compound designed to combat low activity of a natural brain chemical called serotonin – a condition associated with depression and obsessive-compulsive disorders, such as nonstop hand-washing. Problems begin, say neuropharmacologists, when serotonin is absorbed too speedily into the billions of minuscule “receptor sites” at the synapses – the contact points between brain cells. Fluoxetine latches onto the receptors like a key in a lock, to switch off serotonin absorption, or “serotonin reuptake”, thus increasing the presence and action of this vital natural chemical in the brain. Hence, Prozac is known as an SSRI –a selective serotonin reuptake inhibitor – which, scientists claim, elevates the mood of the depressed and increases “impulse control”.

Questions have been raised, however, as to whether an individual, with paranoid fantasies that have been rendered inactive in the depths of depression, gains impetus as a result of fluoxetine to fulfil a murderous fantasy rather than control the impulse. This was the explanation proposed in a civil action in America following 47-year-old Joe Wesbecker’s shooting spree in 1989. He shot 20 of his co-workers at the Louisville Courier-Journal printing plant, killing eight of them, before killing himself. He had been on Prozac for one month.

The SSRI strategy is based on the belief that there is a direct link between the state of our brain molecules and our moods. The co-inventor of Prozac, the late Dr Ray Fuller, once told me during the Wesbecker trial that the SSRI proceeds from the principle that “behind every crooked thought there lies a crooked molecule”.

Three years ago, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued warnings about most antidepressants for children, specifically including SSRIs, on the grounds of risk of suicide. The view was based on a review by a group of medical experts studying all available evidence of clinical trials on both sides of the Atlantic.

The MHRA asserted that the benefits of treating under-18s with any SSRI, except one, Prozac, were outweighed by the risks of side effects. The drugs mentioned were paroxetine (Seroxat), sertraline (Lustral), citalopram (Cipramil) and fluvoxamine (Faverin).

Fluoxetine alone was judged on statistical evidence, and in strict specific circumstances (of which more later), to have a positive balance of risks versus benefits in the treatment of the most severe forms of depression in the under-18s. In other words, when risk of suicide, for example, is so great and persistent that it outweighs the worst-case-possible side effects of the drug.

But the gap between an 18-year-old and an eight-year-old is huge in brain-developmental terms. And Prozac itself has been associated with suicidal patients of all ages, as well as side effects such as stunted growth and deleterious effects on the sexual organs of children. SSRIs have been associated with atrophy of gonadal tissue in boys, indicating future problems with puberty and sexual activity later in life.

It is still not known whether there could be a deleterious effect on a girl’s ovaries. Two years ago, researchers at Columbia University in New York found that young mice exposed to fluoxetine and other SSRIs were prone to abnormal brain development; the drugs appeared to be inhibiting normal neural growth factors. Animal studies have claimed that SSRIs weaken bone growth. There are also addiction issues, as yet unexplored in children owing to lack of longitudinal studies.

Over the past two years, drug companies have been consistently criticised by health bodies in the US and Britain, including a British government advisory group on medicines, for refusing to provide evidence of the side effects of all SSRIs on children, especially Lustral, Seroxat and Prozac. The Lancet recently complained in an editorial that research on SSRIs in children is marked by “confusion, manipulation, and institutional failure”. It went on to charge that regulations are “made entirely redundant if the results are so easily manipulated by those with potentially massive financial gains”.

The use of antidepressants on children, against the background of poor safety reporting, prompts concern about the status of childhood – biological, social and cultural. A regard for childhood as an independent stage in life’s journey – a time for play, discovery, and rapid emotional and physical development – is, in fact, relatively recent in the history of the West. For many centuries, and certainly from the Middle Ages, when infant mortality was high, children were seen as expendable miniature adults with no special physiological or psychological status. By the 17th and 18th centuries, children in England, under the influence of spiritual leaders like the puritanical Charles Wesley, were seen as especially prone to sinfulness and in need of harsh discipline.

By the 19th century, two contrasting perspectives were emerging. Even as children were being exploited as cheap labour, suitable for sending into coal mines or up chimneys, the poets William Blake and William Wordsworth were promoting childhood as a stage of sacred innocence. The idea went back to Plato, the philosopher of ancient Greece, who believed that children had pre-existed in a world of perfect forms. The path to maturity, according to Wordsworth, signalled the onset of the tragic encroachment of the adult “prison house”. The legacy of Blake and Wordsworth, and a consequent tendency towards sentimentality, may well account, up to a point, for the sense of horror, of taboo-breaking, with which many people react to the idea of children on Prozac.

Philosophy and sentiment apart, the neurophysiological unknowns are substantial. The American professors of psychology Alison Gopnik and Andrew Meltzoff claim in their book How Babies Think that typically by the age of three “the number of synapses reaches its peak when there are about 15,000 synapses for each brain cell, which is actually many more than in an adult brain”. They argue that children have brains that are “literally more active, more connected, and much more flexible than adult brains”. So under what conditions could a child, still subject to rapid neurobiological development, show signs of clinical depression comparable to an adult, or even an adolescent, so as to be a suitable case for treatment with powerful mind-altering drugs?

Thirty years ago, when many psychiatrists were still influenced by Freudian psychoanalysis, it was argued that children before puberty had not yet developed a superego, the controlling mechanism of behaviour, and hence could not suffer depression in the same sense as a mature adult. Dr Hills-Smith, an experienced consultant psychiatrist in his early forties working in Weybridge, Surrey, reveals that the conviction is still alive and well in his generation.

“I don’t believe that children before puberty are ever clinically depressed,” he tells me flatly. “They are just sad.” Hills-Smith is a gentle giant of a man who believes that children with emotional problems should never be treated with anything more than talk therapy attended by close involvement of the young patient’s family. “For me, the idea of a depressed child would be something completely new,” he says. But is he just plain wrong? Is it possible that children are changing under new societal pressures, and that psychiatric diagnoses are only now beginning to pick up on the alteration?

If the case of a boy named Sam is anything to go by, depression in childhood is by no means a novelty. Sam lived in a village in rural Devon. The youngest of 10 children (eight brothers and a sister) in the second marriage of an absent-minded widowed father, he was bullied openly by his elder brother Frank, and in secret by a live-in nanny. His mother was emotionally cold. By the age of five he was agitated, prone to nightmares, and a loner. At seven, he attempted to plunge a kitchen knife into his brother Frank. His mum appeared and stopped him just in time.

Sam ran away. Lying by a fast-running river all night, he was saved from freezing to death by a passing neighbour. Not long afterwards, his father died and Sam was sent to a strict boarding school in London. He grew up with a gamut of emotional and behavioural problems, he was prone to excessive mood swings, addicted to a hard drug, liable to compulsive and irresponsible behaviour, and had difficulties with relationships. He left his wife and three children after six years of marriage. Sam’s case history may appear totally of our time, but he was born in 1772, and his name was Samuel Taylor Coleridge – the poet who wrote The Rime of the Ancient Mariner. He has left an unsparing account of childhood depression and its later consequences. In maturity he wrote a powerful poem called Dejection: An Ode:

A grief without a pang, a void, dark, and drear,
A stifled, drowsy, unimpassioned grief,
Which finds no natural outlet no relief.

The interest of Coleridge’s case is its classic repertoire of leading depressive symptoms from childhood, and their association with the original genius that made him a great poet. Critical biographers have seen such childhood dysfunctions as part of the necessary, if painful, underpinning of artistic talents later in life – from John Clare to Sylvia Plath. The same could be said, moreover, of the rich and variegated tapestry of the entire human condition. Had Coleridge been dosed with Prozac, his genius might have been quenched and the world all the poorer for it.

Should we be so overly concerned about the occurrence of even severe emotional tensions and difficulties in childhood to the extent of wishing to eradicate them entirely? Professor David Healey, a psychiatrist who campaigns against the misuse of psychotropic drugs like Ritalin, thinks there is a tendency nowadays to panic about children’s peculiarities, upsets and moods. “The real problem for children and diagnosis of depression is that we are not prepared to live with variation as we did in the past,” he says. “We have more norms of behaviour than we ever had before. We want kids to conform to ideals based often on parental insecurities and ambitions.”

According to the Royal College of Psychiatrists, authentic depression occurs when the feeling of being low or sad “goes on and on, or dominates and interferes with your whole life”. Children can indeed be depressed in this sense, according to the official view of the college, but the incidence is fairly rare: “One in every 200 children under 12 years old, and two to three in every 100 teenagers”.

But is the incidence actually on the increase? Yes, if prescriptions are anything to go by. A recent study based on information from the GP Research Database found that between 1991 and 2001, the rate of British children prescribed antidepressants rose by 70%. In the US, a pandemic is already in progress. One out of every six American children, according to a recent declaration of the House Committee on Energy and Commerce, is taking a prescription antidepressant such as Prozac.

Prozac, according to Nice, should be prescribed only in severe cases of depression. But how severe is severe? Would a psychiatrist recommend Prozac for a boy who has attempted suicide at the age of 11? When he was five, Garry’s mother, who lives in Kent, split up with his father after a period of domestic strife, and took up with a new boyfriend. They got married and Garry’s mother became pregnant again. Garry never grew to like his stepfather, nor to accept the departure of his biological father. He was jealous of his new sibling. He thought of her as an “alien” and wished her dead. There were problems at home, including violent attacks on the half-sister, insomnia, uncontrollable rages.

At school he lacked concentration and truanted. Only after Garry, aged 11, tried to garrotte himself with a belt strapped to the bedstead did his mother seek psychiatric help.

I spoke to his psychiatrist, who insists that he would not prescribe Garry Prozac, although he admits that the boy is much more than just “sad”. “I’ve been making a lot of progress with him in talk sessions,” Garry’s psychiatrist told me, “and he seems to be coming out of it with cognitive behavioural therapy, a kind of talk therapy that deals with his current feelings as he can understand them.”

So in what circumstances would a sensible child psychiatrist recommend mind-altering drugs? Ian Goodyer, professor of child and adolescent psychiatry at Cambridge University, believes that there are very few circumstances indeed. “Of all the estimated 1-in-200 children suffering clinical depression,” he tells me, “you will find just a handful, a tiny minority, so specifically affected that antidepressants may be the best or only answer: where the depression is so severe that the benefits are seen, on balance, to outweigh the undeniable risks.”

I’m convinced, although reluctantly, that I was introduced to just such a child in north London by a child-interest group. I shall call her Hattie. She is the eldest sibling with two younger sisters. “About a year ago she began to self-harm, cutting herself with scissors,” her mother told me. “She had counselling with a clinical psychologist, but nothing seemed to work; she was slashing herself regularly. Then we got really alarmed the day she deliberately swallowed a cup of bleach, at first diluted as if she was experimenting. Then she did it a second time, less diluted, and landed in hospital. A psychiatrist took on her case and he recommended Prozac.”

The psychiatrist insisted that Hattie should take the drug while hospitalised and under constant observation. “There’s a link, as we all know,” says Hattie’s mother, “between Prozac-type drugs and suicide, especially in children and adolescents, so I saw that it was necessary to monitor her constantly.” Hattie’s mother denies that there is any unusual family tension or dysfunction that might have given rise to her daughter’s problems. Significantly, the family is middle class with both parents in professional jobs, and reasonably well off. Hattie’s problems, says her mother, came “totally out of the blue”. Hattie, she goes on, is significantly improved under medication and appears to have conquered her impulse to self-harm. Perhaps understandably, her mother swears by Prozac.

According to Professor Goodyer, a consultant must weigh up extremely carefully the risk-benefit ratio of Prozac, or any other SSRI, in each individual case. The seriousness of the decision is clearly seen in the account of side effects, other than suicidal feelings, in the manual on childhood depression of which Goodyer is the editor: “SSRIs may provoke behavioural activation, in which patients become impulsive, silly, agitated and daring. Other side effects include gastrointestinal symptoms, restlessness, headaches, bruising and changes in appetite, sleep and sexual functioning.”

While there may be a handful of children that Prozac will help, suspicion that expanding prospective use of the drug for children will be commercially driven is irresistible. “Our current state of knowledge,” says Professor Healey, “is hardly sufficient to understand the true nature of the conditions that we are treating, or whether they are truly beneficial.” Marketing of mind-altering drugs, he says, is routinely unscientific in its approach, employing impressionistic hype rather than proper epidemiological studies and full disclosure of clinical-trial data.

There are widespread fears by psychiatrists. Peter Breggin, the psychiatrist, pharmaceutical watchdog and author of Talking Back to Prozac, believes the idea that there is a universal chemical fix for depression will result in the perception that depression itself is on the increase.

“This process,” according to Healey, “is now leading to the medicalisation of all kinds of mental distress in childhood.”

According to neuroscientists such as Professor Steven Rose of the Open University, a deep cultural shift is in progress whereby unhappiness, sadness, depression, and other natural negative emotions, are not explained by talking of circumstances in social and familial relationships, or cultural and economic conditions, but reductively in brain-chemical “levels”.

The mechanism of serotonin, as the cause of depression, has been widely diffused in popular culture through the media and the internet, and its application to children has become inevitable, often through parents. I talked to a GP practising in Corby, the East Midlands former steel town. “A man came into my surgery with his 10-year-old daughter,” she said. “He told me the girl was badly depressed, and demanded Prozac for her.” The man was excitable and menacing. “When I refused to prescribe the drug, he leant over the desk and threatened me physically.” It turned out that the father was himself being treated for depression with Prozac, and his report of the girl’s symptoms, this doctor later discovered, was based on his own adult impression of the causes.

The depths of the cultural change, favouring drug fixes in preference to a multidimensional approach to children’s problems, is further complicated by an increase in pressures and stresses on children, especially within striving middle-class families. Professor Paul Cooper of the Leicester University department of education has cited “school grades, and fear of failure at school”. Cooper has made a special study of the rationale behind the prescribing of Ritalin for ADHD. He is convinced that Ritalin’s widespread use in the United States, and increasingly in Britain, avoids tackling the true problems children face today.

“Children in Britain,” he declares, “are among the most frequently tested pupils in the world, and pupils who do not do well in national tests are increasingly seen as a threat to development and survival of schools and the careers of individual teachers.” At the same time, Cooper indicates that the chief problems relating to “concerns about school grades” and “fear of failure at school” lie outside the “most economically disadvantaged”.

He says it’s not surprising that even pupils take “a highly pragmatic view” of medication, believing it helps them cope with educational pressures. Collecting first-hand evidence from children themselves, Cooper cites this note by a 12-year-old girl: “When I’m on Ritalin I work harder, and I’m nicer, but when I’m out of school and not on Ritalin I’m sometimes silly, or I act stupid or do things that I wouldn’t really do if I was on Ritalin. When I’m on Ritalin I have more control over what I say.”

The group of 100 concerned scientists, psychologists and writers headed by Susan Greenfield believe that a comprehensive alteration in patterns of schooling and parenting is called for – “real play, as opposed to sedentary, screen-based entertainment; first-hand experience of the world they live in, and regular interaction with the real-life significant adults in their lives”.

Are we facing a future in which children will be wrongfully medicated, as parents, teachers and doctors turn readily to chemical fixes as a substitute for tackling normal childhood problems through relationships and talk therapy? Much depends on whether the doctors are prepared to abide strictly by the qualifications laid down by the EMEA and Nice: that Prozac prescriptions must be a final recourse, preceded, and attended, by psychotherapy. If strictly followed, the regulations could put a break on the use of such drugs for children; much depends on the attitudes of parents and the pressures they exert on GPs at a time of declining resources for psychotherapy on the NHS.

YoungMinds, the British advisory group for children with mental-health problems, has counselled parents to be especially cautious. Avis Johns, development director of YoungMinds, says: “The prescription of medication should never be the first and only course of action when children start to experience mental-health difficulties. A holistic approach is essential, involving the family and a range of medical approaches.”

Johns acknowledges, however, that “there could be circumstances where psychological treatment alone isn’t effective”. Ultimately it will be parents who decide whether pressure to resort to Prozac becomes widespread. If British parents take the lead already established in the United States, it will be the more affluent who turn to the medication fix.

Depression in children, it is becoming increasingly clear, is not only a consequence of family dysfunction, marriage break-ups, child abuse, and combinations of genetic and environmental disadvantage. Depression can lurk and flourish in the minds of “normal” children whose parents deliver them to £5,000-a-term day schools in top-of-the-range 4x4s. Childhood psychological misery can be found in an ambience of back-to-back improving activities – from flute lessons to tennis training to private maths tuition; in the pony club and on the junior ski slopes.

When such children falter and fail, turning to forms of self-hatred and self-harm, will their striving, over-anxious parents wake up to their own failings and inadequacies? Will they be able, as Madeline Levine counsels, to belatedly allow their children to be average or below average, giving them time and opportunity to discover by themselves who and what they are? Or, encouraged by official recommendations, will they readily turn to medication such as Prozac as yet another means of seizing a procurable advantage for their kids’ challenged performance?

For help, visit www.youngminds.org.uk or telephone the Parents’ Information Service, a confidential helpline, on 0800 018 2138

Prozac nation for pre-teens

Is it right for children to be medicated out of their sadness? Or is it a case of pushy parents and unscrupulous drug companies? GPs weigh in on the debate

DR RICHARD CHURCHILL, NOTTINGHAM
A fair proportion of children with depression will get out of it within two or three months without any intervention. I was on the Nice guideline development group and my understanding is, the younger the child, the less likely you are going to see a result from an antidepressant. With a child under 12, I would be very reluctant to prescribe. The big worry with Prozac is that it can increase the risk of suicide.

DR PENNY MOORE, NORTH OXFORD
I see a huge pressure for children to achieve; some of their depression and anxiety could be relieved by parents taking that pressure off. There’s a mismatch between expectations and how a child can actually function. I see child depression rarely, but it may be under-diagnosed. For that age group, psychiatrists almost never prescribe antidepressants. I think that licensing Prozac could cause an increase, if parents start to follow America’s pattern and start demanding it more.

DR DEBORAH BEALE, WESTBURY, WILTSHIRE
I’ve seen an increase in childhood depression over the past five years. I see as many as one or two cases a month. Making the diagnosis is harder in younger children, as they may not have the right words to express their feelings. If children need medication they should have access to it, but there should be strict monitoring to make sure we are not doing them harm, and it should only be used with other non-pharmacological therapies. Just because it seems safe now, you don’t know what the true consequences will be.

DR ALAN COHEN, SOUTH LONDON
I haven’t come across a child who’s been on Prozac, nor have I prescribed it. I’m happy to write a prescription if a child psychiatrist tells me that this is important, but I would expect the child to be monitored and supervised by the psychiatrist. The number of children who do end up on antidepressants is relatively small, but if there’s evidence that a drug works well in a child and it’s safe, then that’s great — let’s have that available.