March 20 2007
Countless children labelled hyperactive are being subdued with drugs like Ritalin. But many experts think they're just naturally boisterous - and those needless pills are causing terrifying side-effects.
"As soon as Jack arrived at nursery at the age of three, the teachers realised he was trouble," says his mother, Rozalyn Harrison. "He wouldn’t sit still; instead he was constantly running around being a nuisance.
"Sometimes it got so bad that the moment I got home after dropping him off, I’d get a call asking me to collect him. At home he’d scream and cry if he didn’t get what he wanted. He put holes in doors, smashed windows, and broke anything he could lay his hands on. Going shopping was a nightmare; I couldn’t do anything to calm him down.
"If he got upset, telling him off made him even more angry. His sister got some of the worst of it. He’d often give her a black eye."
By the time Jack was six he was on Ritalin. He had been assessed as having ADHD, "oppositional behaviour" (he didn’t do what he was told), learning difficulties and behavioural problems.
"I could have told them that," says Mrs Harrison, 41, a full-time mum from Norfolk. "But apart from the drug they never gave him any other kind of treatment. Sometimes it quietened him down and he’d sit and do nothing for hours on end."
Jack is one of a growing number of children diagnosed with attention deficit hyperactivity disorder, or ADHD — these children are often disruptive and have difficulty focusing their attention. As in Jack’s case, their relationships at home and at school are difficult and they rarely have many friends. It’s been estimated that as many as 400,000 children in the UK have ADHD.
Like Jack, many are being given amphetamine-type drugs such as Ritalin, Adderall or Concerta. These are thought to work by increasing the amount of the brain chemicals needed to help concentration, although some parents, such as Rozalyn Harrison, say they seem to have a sedative effect.
Figures published last week show that NHS spending on these drugs has tripled in the past five years, to £12.8 million. Much of the rise in prescribing is driven by parents desperate for anything that may help.
It also encouraged by some experts who believe that ADHD could affect as many as 5 per cent of school children; one or two in every class, each a potential candidate for treatment with drugs.
But although some children undoubtedly do benefit, and many parents find them a godsend, there is growing concern that ADHD is being overdiagnosed — that it is being used indiscriminantly to label children who have other problems, or who may simply be badly behaved. Some experts are worried that calming these children down with drugs does nothing to deal with the underlying causes.
Even more worrying are the claims that parents are not being given an accurate picture about the risk of side effects — most notably the raised risk of psychotic episodes. Last year the American Food and Drugs Administration advised that ADHD drugs should have stronger warnings about this type of psychiatric side effect.
Children aged ten and younger who took ADHD drugs described seeing, for example, polka dot alligators or hallucinated that all their Christmas presents were being stolen by men who broke into their house. The FDA review noted that "in 90 per cent of these cases the patients had no prior history of similar conditions".
In other words the effects were most likely caused by the drug rather than being a symptom of ADHD. The risk was estimated at one in 1,000 but with several hundred thousand prescriptions, that’s several hundred children who could be affected.
However, such warnings are not currently being given to the parents of children on these drugs in the UK.
At the end of 2005 the British drug watchdog, the Medicines and Healthcare products Regulatory Authority, found there had been more than 6,000 reports of psychiatric side effects involving one such drug, Strattera.
Some were relatively minor, such as insomnia, but others included suicidal thoughts and hallucinations. This report is yet to be made public, although it was available to the FDA when conducting its review.
Last month, just when the British media was reporting on the sharp rise in the prescribing of these drugs, which are given to children as young as six, the FDA told the drug companies to draw up clearer labelling warning of the risk of psychosis and hallucinations.
The side effects the FDA is now warning about come on top of a number of other serious effects already known.
The most commonly mentioned include nausea, loss of appetite and sleeplessness. But they also include raised blood pressure, a risk of epileptic seizures and abnormal heart rhythms, increased risk of suicidal thoughts, attempted suicide (this was found in particular with Strattera), hostility and mood swings.
Even so both the UK and American regulators say that "overall, the balance of risks and benefits remains positive". However, the current patient information leaflet for Strattera says only that serious psychiatric adverse events cannot be excluded and contains no mention of psychosis and hallucinations.
Asked by the Mail whether parents are getting a true picture of the risks, a MHRA spokesman said: "Psychiic reactions with Strattera are kept continually under close review and the summary of Product Characteristics will be updated as necessary."
Eli Lilly, Strattera’s manufacturer, said: "The current warnings in the product information are agreed by the MHRA and accurately reflect the available details in this area."
But there are "safer" alternatives, including an old-fashioned psychological approach.
The dramatic rise in prescribing for ADHD raises the question of why children’s behaviour is getting worse. Dr Sami Timimi, a consultant child and adolescent psychiatrist in Lincolnshire, believes there is a danger that ADHD is becoming an umbrella term for simple bad behaviour.
"There is no test for ADHD. It is diagnosed on the basis of a questionnaire, which is subjective," he says. "We are creating ADHD out of behaviours that would previously have been perceived as normal. There is a temptation to use it as a get-out — by parents, teachers and doctors."
He and other experts such as Priscilla Alderson, Professor of Childhood studies at London University, believe undesirable behaviour is more common because family life has changed. Children take less exercise than they used to; they spend much of the day sitting in front of TVs and computers and they eat more additive-laden foods.
On top of that, the educational system has become more target-driven and parents are more likely to be working, separated or divorced. "It is harder than ever to be a normal parent these days," says Timimi. "The expectations are higher."
At his practice, he rarely uses drugs and only in emergencies. "Even though I see a wide range of very disturbed children, I rely on psychotherapy and looking at the children in the wider context of their family and school," he says.
He uses family therapy to deal with issues that might be causing conflicts and parents are advised on how best to deal with their children.
The importance of such an approach is recognised in the NICE guidelines on ADHD — these recommend that drug use needs to be backed up by psychological and social support. However, lack of resources means that all too often these factors are ignored and drugs become the mainstay.
In fact, some experts believe it was the 2000 NICE guidelines that paved the way for the huge rise in drug use, because it says that even though treatment "should involve advice and support to parents and teachers", if that isn’t available that "should not be used as a reason for delaying the appropriate use of medication".
There are only a few units around the country that offer help to troubled families whose children are more likely to be diagnosed with ADHD, such as the Family Well-being Project in Birmingham or the Parent Adviser scheme in Tower Hamlets in London.
If only the three-fold increase in expenditure on drugs could be repeated for psychological services.
But psychotherapy and social support isn’t the whole answer, either. Most experts recognise that 70 per cent of children with ADHD have other problems as well, such as learning difficulties, dyslexia, difficulties with co-ordination (dyspraxia) or even a condition related to autism.
There are few centres that attempt to untangle all the other factors. One of these is the Eide Neurolearning Clinic in Edmonds, Washington State, run by the husband-andwife team Brock and Fernette Eide — he is a doctor and she is a neurologist — where they test six to 12-year-olds with school or learning difficulties.
"ADHD is a diagnosis based on a child’s behaviour, but behaviours — such as a limp or a cough — can have all sorts of causes; so can not paying attention or constantly fidgeting," says Dr Brock Eide. "Usually we find a variety of causes for their behaviour rather than a general problem with attention.
"Many of the children have undiagnosed reading or writing problems. Often, their neurological systems for handling information from their eyes, ears or muscles aren’t working as well as they should.
"This can make it very hard for them to handle the barrage of information coming in from a busy school environment. And what do you do when you are confused or can’t follow what is going on? You very likely fidget and don’t pay attention. And then start playing up."
Sometimes the underlying problems can be treated by relatively simple techniques that take advantage of the fact that children’s brains are remarkably plastic and can be retrained to work in a different way.
"In other cases, it may be the school environment that is causing the problem," continues Dr Eide. "If you are a child whose brain is slow at making sense of sounds, for instance, then you are going to have problems following instructions in a normal classroom.
"Changing the way such children are taught can make a big difference. For example, there are computer programmes that can help to retrain the hearing part of the brain."
However, not everyone can take their child to an expensive clinic for a full examination, which is where an award-winning £150 software package entitled SNAP (Special Needs Assessment Profile) comes in.
"SNAP is based on the idea that no two children with learning or behavioural difficulties will be identical," explains Dr Charles Weedon, a teacher in Edinburgh, who developed SNAP with an educational psychologist at Edinburgh University. "The underlying causes can be quite different."
At the heart of the programme is a detailed questionnaire which both teachers and parents fill in about the child. The software then compares this with a database of patterns of thinking and behaviour known to be linked with 18 underlying disorders.
"This allows for a much more specific diagnosis than the standard ADHD umbrella, which in turn allows more targeted treatment."
Young Jack, who caused havoc at nursery, is just the sort of child Dr Weedon believes could benefit from the SNAP approach, rather than being put on a drug automatically.
"The programme can pick up, for instance, that a child has dyspraxic difficulties. This means that he may find his own body an uncomfortable place to be. He’s constantly getting too much or too little stimulation, so he fidgets." Specific physical exercises can often then help with this.
Another problem the programme can pick up is an omega 3 fatty acid deficiency. This is one of the alternative treatments for ADHD that has probably had the most publicity.
Two years ago, a scientific trial at Durham University found that a commercial fish oil blend called Eye Q significantly improved many symptoms.
One child who has benefited from fish oil is Jack. He is now ten and for the past two years has been on six capsules a day. "Soon after starting it, he seemed much calmer," says Mrs Harrison. "He was much more willing to listen. We even got him to read books. You could take him to the pictures and enjoy it."
Jack now also attends a specialist school, where there are only five to a class, and keeps to an intensive round of daily activities.
But why are fish oils so effective? That is the question being tackled by a new research project at the Institute of Psychiatry in London, which is using a high-resolution brain scanner to look at changes that fish oils produce in the brains of 60 adolescents with ADHD.
"We know that if you make rats deficient in omega 3, they show up a pattern of brain waves similar to what we see in some people with ADHD," says researcher Alex Sumich. "If you then give them omega 3, the pattern reverts to normal."
However, if children like Jack are to get more targeted help for their problems than drugs to calm them down, we need more scientific exploration of the alternatives.
The clinical experience of nutritionists, for instance, suggests that a number of other dietary changes can make a big difference to ADHD children. Reducing sugar intake, treating deficiencies in minerals such as zinc and magnesium, treating food intolerances — these can all lead to improvements. And there are sound biochemical reasons why they should have an effect.
But in the absence of controlled trials, such ways of handling ADHD, let alone uncovering neurological problems and treating them with exercises, will continue to remain on the fringe, even though it is what many parents and teachers say they would prefer.
In the meantime, expect to hear a lot about a new drug called Vyvanse which is set to replace the ADHD drug Adderall next year because the latter’s patent is about to run out.
The makers of Adderall have just paid $1.3 billion for rights to Vyvanse and need to get their money back. It’s a sum that would fund a lot of nutritional trials.
The Mislabeled Child by Drs Brock and Fernette Eide is published by Hyperion Books at £15.99.