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Healthy Skepticism International News

November 2006

What are we doing to our children? / Do we have a prescription addiction?

Jerome Burne (.(JavaScript must be enabled to view this email address)) is a journalist living in London. He works for most of the national newspapers, for the last 15 years specializing in science and medicine. One of his interests is the gap between the fine ideal of a medical system based on science and evidence, and the reality;  marketing and commercial needs tend to trump the science. His book “Food is Better Medicine than Drugs” written with clinical nutritionist Patrick Holford was published in October 2006 by Piatkus.

The following two articles were published in edited versions in the Daily mail in 2006.

1. What are we doing to our children?

James was ten years old when he was first put on an antidepressant. His mother was an invalid and after his father had left home, the pressure of caring for him had become overwhelming. “He started showing signs of depression,” says Jude Sellen, a specialist CAMH (Children and Adolescent Mental Health) consultant at the charity Young Minds, who was involved with his case.

“Sometimes he would sit and stare into the middle distance not responding to anything, other times he’d lock himself into his room; he cried a lot. Increasingly he refused to go out because he was being bullied at school. His situation was very difficult and he badly needed psychological help.”

What he got instead was long-term treatment with SSRI (serotonin selective reuptake inhibitor) anti-depressants. He was still on one of these drugs two years later. ““Sometimes he’d stop taking them,” says Sellen “because they gave him stomach problems and they said they made him feel “funny”. But then when he stopped he’d sometimes become violent - a known side-effect of some of the drugs - and his mother insisted that he go back on them.” 

Last week a new set of guidelines recommended that depressed children as young as eight could safely be given an SSRI, raising concerns that this may be too young to be treated with a class of drugs that have been linked with a raised risk of suicide and problems of withdrawal. Is it an unwelcome move in the American direction where three-year-old can be put on SSRIs?

  Prescribing drugs to children at an increasingly young age in the States has begun to trouble some researchers, because almost nothing is known about how these drugs might affect their growing brains. “This is ignorance in the broadest sense of the term,” said Dr. Glen R. Elliott, a child psychiatrist at the University of California at San Francisco. “We don’t know if this is a good idea or not.”

The drugs may also stunt growth. One trial reported two years ago found children between the age of eight and 17 given Prozac were on average 1cm shorter and 1.1kg lighter than those on a placebo. In fact how precisely how SSRIs work is still a mystery, even though we all think we know it’s because they increase the amount of “feel-good” chemical serotonin in the brain. However the evidence for this theory is surprisingly thin; the latest research suggests that they work by encouraging the growth of new brain cells. Whether this is good for a young brain that is already growing fast is also unknown.

Even so most clinicians feel that such risks are worth taking when faced with the pain of a child who is severely depressed and who may be helped by them. In fact the new guidelines, which come from the European Medicines Agency and apply all over Europe, recommend that the first line of treatment should be psychological therapy. Then only if that fails, should an SSRI be prescribed but only fluoxetine – the name of the chemical in Prozac.

So are they going to improve the way that depressed young children in Britain are treated? “The guidelines fit very well with what we do already,” says David Cottrell, Professor of Child & Adolescent Psychiatry at the University of Leeds. “Most experts now recognise that psychological support is very important and should be tried first, but there are cases where a drug can help. Prozac has been the only drug recommended for children here since 2003.”

But quite apart from the question marks about what the drugs are doing to young brains, the new guidelines point up two very serious failings in the current system. The most obvious problem is the drastic shortage of therapists. James, for instance, went for two years without getting any counselling. Provision of psychological services across the country is notoriously patchy; a recent report estimated that 10,000 more therapists were needed to provide effective treatment for depression in all age groups.

But there is a more deep rooted problem, hidden until now, to do with the drugs that the children are actually being prescribed. Official guidelines both here and now Europe may say that Prozac is the only drug with good evidence that its effectiveness outweighs the raised risk of suicide known to come with these drugs. However research by the Daily Mail has found that doctors are continuing to prescribe large numbers of drugs that have no evidence of befit at all and supposed to banned from use with children.

Figures on prescribing released in Parliament earlier this year in response to a question by Lib Dem MP Paul Burstow show that four SSRIs, which the drug regulator has said should not be used are still widely prescribed. Children like James, who may not be getting psychological support, could still be getting drugs such as venlafaxine (Effexor), which not only is unlikely to produce any “clinically important improvement” but, astonishingly, has a rate of “suicide related events” fourteen times greater than a placebo.

These conclusions come from a major review, published in the Lancet in 2004, of the all the evidence for the safety and effectiveness of the five SSRIs most commonly used to treat children. Its conclusion on another of them, Citalopram (Cipramil, Celexa), was equally worrying: “it is unlikely to produce clinically important reduction in depressive symptoms” and doubles the risk of suicide.

One of the authors of this study was Professor Cotterell, who explained that it was unusually reliable because it combined published with unpublished trials. “We found that all the unpublished trials were less favourable” he said dryly. The conclusion was the only Prozac was suitable while the others - including Paroxetine (Seroxat) and Sertraline (Zoloft) - should be avoided. The intention of the trial was to provide information to guide to doctors.

But rather than set the alarm bells ringing in the surgeries, the Parliamentary figures show that of all the antidepressant prescriptions written for children under 18 in 2004, only around 30% of them are for Prozac, at a cost of £407,107, while 35% are for one or other of the four banned drugs at a cost to the NHS of over £1.6 million. Not evidence based prescribing and not a good deal in these cash-strapped times.

But apart from the safety issue, the new guidelines come at a time when several big reviews have queried whether SSRIs are really beneficial for adults. Last year, for instance, Joanna Moncrieff, a lecturer in psychiatry at University College London, published a review in the British Medical Journal which concluded that SSRIs have “no clinically meaningful benefits over a placebo”. She called for more effort to put into researching alternatives to drug treatments.

If children like James are ever to have a real chance in life, there needs to be much more attention paid to providing the kind of psychological support that everyone agrees is needed and there should be a serious attempt to cut prescribing of drugs that are known to be ineffective and dangerous for children. If this isn’t done, CAMH consultant Jude Sellen believes that the long-term effect of the new guidelines could be a string of court cases in ten or twenty years’ time.

“The guidelines have set out what the best practice is according to the evidence,” she says “and it’s clear that many children aren’t getting that. Unless the various mental health providers make much more serious attempts to provide it, children like James could have a strong case for suing the people who were supposed to be looking after them when they grow up.”

2. Do we have a prescription addiction?
Many were shocked at the news last week that a doctor was prepared to prescribe four-year-old Mollie Murphy the anti-depressant drug Prozac. Having failed to get into the school all her friends were going to, she was very upset – crying constantly and bed-wetting.

Experts such as David Cottrell, Professor of Child & Adolescent Psychiatry at the University of Leeds described the prospect as “mind boggling” and advised counselling and support for the family instead. Is the drugging of Mollie a sign that our pill-for-every-ill culture has finally gone too far?

But psychiatric services for children in Britain are caught in a bind. While psychological support and counselling is recommended and works well, waiting lists to see an expert stretch for a year or longer. So faced with a growing number of distressed youngsters, hard-pressed doctors turn to pills.

So far the concern has mostly been about the use of drugs such as Ritalin and Prozac. But a Daily Mail investigation has discovered a worrying trend. While the use of anti-depressant drugs is actually decreasing, heavyweight drugs normally used to control psychosis are increasingly being prescribed to troubled children in England.

For some parents their children’s misery and distress makes them prepared to try any drug that may help. Jane began cutting herself with scissors about a year ago. Aged 10, she comes from a middle-class family in north London; her parents are professional and she has two younger sisters.

“It came out of the blue,” her mother says. “I can’t think of any strains or family problems that could have lead to it.”  They tried counselling but it didn’t seem to help.  The family became really worried when she swallowed a cup of bleach and was rushed to hospital. The psychiatrist there recommended Prozac.

“They kept her in hospital so she could be properly monitored,” says her mother “because there is a chance that Prozac can increase the risk of suicide.” But in this case the drug made a big difference, Jane seems to have stopped self-harming and the family are relieved and delighted.

Of course every family is different but other children may get anti-depressants with less justification. Also last week a survey of GPs found that a third of them felt “bullied” by middle-class parents to prescribe anti-depressants to their children who had become unhappy and distressed. But the survey also found that two thirds of the doctors also said they had seen a rise in the numbers of children with mental health problems, including depression, self-harm and eating disorders.

Explanations as to why so many of our children are unhappy include inadequate child rearing skills, lack of affection, marriage break up and increased pressure pushy parents and exam fixated schools. Solutions range from intervening early with dysfunctional families to giving children more time to dream.

But only 25% of children with significant mental health problems get to see any experts at all, so for many drugs are what they get in practise. What may come as a surprise with all the concern about giving anti-depressants to children is that their use is actually declining in England. Figures obtained from the Department of Health show that between 2002 and 2005 the number of prescriptions fell from 260,000 to 215,000.

This has undoubtedly happened because of the now familiar concerns about the raised risk of suicide and studies showing that they are of limited effectiveness for children. The only one licensed for children is Prozac but a number of neuroscientists are now concerned about what this drug may be doing to young growing brains. You can’t do this research on humans so the warning signs are coming from animal work.

Baby mice given fluoxetine at the human equivalent age of between zero and eight, grew up to be more anxious and depressed. The researchers at Cornell University in New York believe this may be because fluoxetine increases the amount of serotonin and in growing brains serotonin is one of the chemicals that help to control the process. “Over-stimulation,” commented the lead scientist “could result in abnormal development.” 

But fluoxetine does something else in the brain - it speeds up the growth of new neurons. What is the long term effect of artificially boosting in a rapidly developing brain? No one knows. Just as no one knows why growing new brain cells should improve mood.

One way of dealing with all this uncertainty, you might think, would be to only give very low doses but even that might not be a good idea if another troubling animal study published last month (October) is confirmed.

Neuroscientists at the University of Texas reported that giving low doses of fluoxetine to young hamsters made them more aggressive while older ones calmed down. “It is yet more evidence that during puberty the brain is still maturing and may react to adult drugs in a different and potentially negative way, says the lead author. “The results offer tantalising clues as to why some teenagers taking common anti-depressants become more aggressive or kill themselves.”

None of this is of any help, however, to the hard pressed doctor who is still prescribing Prozac because it undoubtedly does help some children and because there is often nothing else easily available. But the situation is about to get even worse.

The Daily Mail has found that as prescriptions for antidepressants have been declining, virtually unnoticed prescriptions to children for a much more powerful and dangerous class of drugs normally reserved for schizophrenics, has increased by over 50% in the last four years. Called antipsychotics, there were 50,000 prescriptions for them in England in 2002; last year that had risen to 79,000.

“These figures certainly come as a shocking surprise,” says Professor Cotterell. “Using antipsychotics on children raises serious ethical concerns. None of them is actually licensed for use on children and for adults they are only licensed for schizophrenia and psychosis. In children they are being mainly used for behaviour control. There is no doubt they are effective; a heavy tranquilizer will stop someone misbehaving, but that doesn’t mean it is right to do it.”

In America there has been growing concern about increased prescribing of antipsychotics to children - up by 500% between 1995 and 2002 and by a further 80% between 2001 and 2005. A major worry is their side-effects, the most severe being death.

  An analysis of just one of the FDA’s (Federal Drugs Administration) database by the LA Times found antipsychotics were linked with the deaths of 45 children between 2000 and 2004. This particular database holds about 1% of the total number of adverse drug reactions.

  Another “milder” adverse reaction is dystonia – involuntary often painful muscle contractions, which can show up as muscle tremors and facial grimacing. Also common is weight gain and with it a raised risk of diabetes. There are reports of children putting on 100 pounds in a year after taking the drugs.

The brand most associated with weight gain is Zyprexa (olanzapine.) Last year the manufacturers established a $690 million dollar fund to settle lawsuits brought by American patients who claimed the drug had caused them to develop diabetes. The company said that the claims were without merit. Between 2003 and 2005 the number of prescriptions for Zyprexa issued to children in England nearly doubled from 6,000 to 11,000.

Despite his severe reservations about using antipsychotics Professor Cotterell has used them once when everything else had failed. “John had severe learning difficulties; he couldn’t speak and could only use the most basic signs,” he says. “He would have very aggressive outbursts, kicking and biting. As he got older and stronger, they became more dangerous. We did everything we could to help the parents handle John; they couldn’t have done more.

“But by the time he was about nine his outbursts were still bad. So after a lot of heart-searching we decided to try him on a low dose of an antipsychotic and it worked very well. The attacks were greatly reduced and his quality of life improved. His family could take him out. I think we were justified but you have to try everything else first.”

However all the clinicians contacted were concerned about the increasing use of antipsychotics. “These are drugs that have very limited use,” says Dr Sami Timimi, consultant child and adolescent psychiatrist at Lincolnshire Partnership NHS Trust.  “They should only be used for genuinely psychotic youngsters for the temporary management of distressing symptoms but there is no evidence that psychosis is increasing. Instead they are being used for autistic spectrum disorders, ADHD and a range of borderline conditions. But they have not been adequately tested and their increasing use is going to create a whole new generation of problems.”

Given the narrow range of options open to clinician facing sad or aggressive children there is increasing interest in the role food and nutrition can play. The usual complaint is that there is not enough good trial evidence – although there is very little trial evidence underpinning the use of antipsychotics either – but last summer came the first report of a double-blind controlled trial of omega-3 fatty acids on depressed children between six and 12.

It was only small – 28 subjects – but the results were that 70% of those on omega-3 had more than a 50% drop in their depression scores and nearly half stopped being depressed at all. The trial, published in the American Journal of Psychiatry, found no adverse effects.

It is rare to find a nutritional approach to mental health within the NHS but the Brain Bio Clinic in London was set up to help both adults and children with psychological problems by changing their diet and correcting nutritional deficiencies. They regularly find that patients with behavioral problems also aren’t in very good physical shape. 

‘Many of the young children we see have been on drugs like Ritalin or Prozac or in special schools,” says a nutritionist at the centre Lorraine Peretta. “They may have ear, nose and throat problems, with excess mucus and an above-average number of infections; all of which are signs of poor nutrition.”  That’s then often combined with some kind of skin rash or allergy, like eczema, as well as a food intolerance of some sort. Finally, they usually suffer from chronic constipation or diarrhoea because their guts are disordered. 

The key insight at the Brain Bio Centre is that when you sort out these imbalances with diet and supplements where necessary, not only do the physical symptoms clear up but the psychological ones also improve. Counseling and therapy then have a greater chance of being effective.

Faced with the risks of anti-depressants and antipsychotics an active program to gather evidence on how best to use the nutritional approach would seem essential.

 

 

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