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A children's health scandal exposed

MagazineFebruary 2004 (Vol. 14 Issue 11)A children's health scandal exposed

Children as young as two are being prescribed powerful mood-changing drugs such as Prozac and other antidepressants

Children as young as two are being prescribed powerful mood-changing drugs such as Prozac and other antidepressants. Although usage usually begins at the age of six and then carries on until the age of 19, the number of two- to four-year-olds taking stimulants (such as Ritalin), antidepressants (such as Prozac), antipsychotics and clonidine (used to treat adult high blood pressure and insomnia in hyperactive children) has skyrocketed.

Data from America show that, from 1988 to 1994, antidepressant use in children increased 400 per cent (Pediatrics, 2002; 109: 721-7). Today, around 2 per cent of all youths are taking antidepressants.

In one review carried out in France, 12 per cent of the children beginning school were receiving psychotropic medications, mostly phenothiazines; 76 per cent of these had started treatment by age four (Rev Epidemiol Sant'e Publ, 1992; 40: 467-71).

Last year, UK doctors wrote 170,000 prescriptions of antidepressants for children.

Of all the antidepressants, the increased use of selective serotonin reuptake inhibitors (SSRIs) among children has been the most dramatic, with a 10-fold increase from 1993 to 1997 (Can J Psychiatry, 1998; 43: 571-5).

Only eight per cent of GPs and paediatricians have received adequate training in the management of childhood depression. Yet, that has not stopped 72 per cent of them from prescribing SSRIs (such as Prozac) to children under 18 (Pediatrics, 2000; 105: e82).

In addition, 57 per cent of these physicians acknowledged having prescribed an SSRI for a diagnosis other than depression in an under-18-year-old patient. These included children diagnosed with attention-deficit and hyperactivity disorder (ADHD), obsessive-compulsive disorder, aggression/conduct disorder and even enuresis (bed-wetting).

Off the label
Once a drug is approved and on the market, further studies to determine its safety and efficacy in infants and children are rarely conducted (Curr Opin Pediatr, 1995; 7: 195-8). So, many medicines used for children are not licensed (have marketing authorisation) or are used 'off-label' (outside the terms of the product licence) (Arch Dis Child, 1999; 80: F142-5). Such prescriptions depend on little more than 'educated guesswork' and 'experiences of peers'; they are not supported by scientific evaluation.

Concerns over the use of unlicensed and off-label drugs in children were first raised in the late 1960s (J Pediatr, 1968: 72; 119-20). The alarm went unheeded, however, and the practice of off-label prescribing for children is now a worldwide phenomenon (JAMA, 2000; 283: 1059-60).

A recent survey of five European hospitals analysed 2262 prescriptions given to 624 children and found that nearly half were either unlicensed or off-label. On the whole, 67 per cent of children received an unlicensed or off-label prescription (BMJ, 2000; 320: 79-82).

Drug safety in children cannot be inferred from widespread use. Nor can safety in adults be used to infer safety in children, as they are not 'little adults'. Indeed, off-label use in children on paediatric wards has been shown to produce many more adverse effects than drugs properly licensed for use by children (Acta Paediatr, 1999; 88: 965-8).

Suicide and self-harm
With children, the picture of adverse drug reactions is complicated, as they often react to drugs in a completely different way from adults. Consider the paradoxical responses to phenobarbital in children vs adults. Phenobarbital acts like a sedative in adults, yet produces hyperactivity in children.

Conversely, Ritalin (methylphenidate), a cocaine-like drug, is used as an antihyperactive drug in children, but produces a stimulant effect in adults.

Without adequate studies, it is left to postmarketing surveillance, when it exists, to turn up adverse effects. The results are often distressing.

Recent reports have raised concerns that SSRIs may be associated with an increased risk of suicide in children. Two of these - venlafaxine (Efexor) and paroxetine (Seroxat/Paxil) - have recently been banned for children because the risk is so great. Last September, the UK Committee on Medicines announced a ban on Efexor. Only months earlier, Seroxat was similarly banned for children in the UK, Canada and Ireland.

In both cases, previously concealed evidence from controlled clinical trials conducted by the drugs' manufacturers, Wyeth and GlaxoSmithKline, respectively, had shown that children taking SSRIs were driven to acute emotional distress, leading some to become suicidal or homicidal.

Only when this concealed information had been uncovered did healthcare providers receive letters from the manufacturers confirming that the drugs caused an increase in problems such as aggression, suicidal thoughts and attempts, and self-harm rates by up to 3 per cent.

Newspaper reports suggested that both drug companies knew for several years that their products could be causing children to feel murderous and suicidal (see www.guardian.co.uk/uk_news/story/0,3604,1045902,00.html).

The manufacturers were able to conceal these effects in their own studies by describing the intense emotional distress and violent behaviour of the children taking the drugs as 'emotional lability', a euphemism not uncommon in clinical research that should have, but didn't, raise alarm bells for drugs regulators.

The increased risk of suicide among young children is not new. In one study carried out by Yale University, 14 per cent of young people aged 10 to 17 developed tendencies towards, and thoughts of, self-injury while taking fluoxetine (J Am Acad Child Adolesc Psychiatry, 1991; 30: 179-86). This effect has been noted in adults as well (Am J Psychiatry, 1990; 147: 207-10).

While Efexor and Seroxat are no longer recommended for children, the suicide risk has not gone away. A review by the US Food and Drug Administration (FDA) of 20 placebo-controlled trials, involving over 4100 children and adolescents prescribed one of eight antidepressants - citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline and venlafaxine - conceded that these were all more likely than a placebo to cause suicidal thoughts.

Adding insult to injury, the FDA also concluded that there was no evidence that the drugs were effective in treating childhood depression.

Pfizer, the manufacturer of sertraline (Lustral/Zoloft), was quick to distance itself from the review by recently funding a study of 376 depressed children (aged 6-17) that found that sertraline was 'effective and well-tolerated' - despite the fact that 17 of the children withdrew from treatment because of an adverse effect, and that two attempted suicide (JAMA, 2003; 290: 1033-41).

In the face of overwhelming evidence, the UK's Medicines and Healthcare Products Regulatory Agency finally banned the prescription of SSRIs to under-18s in December 2003, although the practice continues elsewhere in the world.

Developmental damage
Whether the use of antidepressants and stimulants leads to addiction later in life is also poorly studied. Although recent evidence suggests childhood use of stimulants like Ritalin does not lead to stimulant addiction in later life (J Clin Psychiatry, 2003; 64 [Suppl 11]: 9-13), there's a catch. These studies generally look for physical, not psychological, addiction.

Proponents believe that children clear medications from their bodies quicker, thus leading to less physical addiction. This may or may not be true. Nevertheless, there is still the unresolved matter of potential psychological and spiritual damage from taking psychotropic medicines.

Giving children medicine at the first sign of a problem, whether paracetamol for a headache or Prozac for a bad mood, sends a powerful message to the youthful mind - pills will cure your ills. It's a message that drug companies would like to see embedded in all of our minds.

In fact, it is the hidden damage of early drug use that is most difficult to spot and remedy. Early childhood is a time of tremendous changes in the human brain. Cerebral metabolic rate peaks between ages three and four (Ann Neurol, 1987; 22: 487-97), and visual processing, language and motor skills are acquired at this time. The influence of mind-altering medications on the timing and direction of physical and mental development is simply not known (J Am Acad Child Adolesc Psychiatry, 2003; 42: 651-5).

For this reason, a recent review (JAMA, 2000; 283: 1025-30) concluded that the 'possibility of adverse effects on the developing brain cannot be ruled out'. The report's authors then went on to recommend that now is the time for parents to start actively looking for signs of subtle changes in the developing personalities of their children, which could be the direct result of mood-altering drugs on the neurotransmitters of the brain.

Barriers to change
Many things stand in the way of effective medical treatment for children. One is the ethical issue of testing drugs in children. What parents, after all, would consent to such participation and potential harm of their child?

Yet, the extensive off-label use of medications in children suggests that many are already participating in such research (J Law Med Ethics, 2000; 28: 362-78).

Also, paediatric drug use traditionally represents only a small portion of the market, so there is little incentive for paediatric drug testing. To comply with current regulations, drug companies need only insert a disclaimer, cautioning against paediatric use.

Even so, a review by Australian authorities found that 70 per cent of the products surveyed had either no information, or only a partial or general disclaimer regarding use in children (Report of the Working Party on the Registration of Drugs for Use in Children, Canberra: Therapeutic Goods Administration, 1997). This finding is similar to that of the US Physicians' Desk Reference (Pediatrics, 1999; 104: 598-602).

Clearly, whatever the official line, children do not have equal access to 'safe' regulated drugs. But other socially based problems have promoted the acceptance of the use of mood-altering drugs by children.

Chief among these is how parents are continually being encouraged to abdicate their parental responsibilities to doctors, schools, social services officials and, ultimately, drug companies.

There is also the growing belief, unique to the post-baby-boomer generation of parents, that all children must fit into an idealised behavioural picture - well behaved, uncomplaining, never bored or fussy and never an inconvenience to the parents. The more widespread this expectation, the more children will be diagnosed with 'behavioural problems' and 'depression'.

The backlash against Ritalin and overdiagnosis of ADHD may also be a factor. Parents unhappy with the 'diagnosis' of ADHD have successfully argued that the symptoms of ADHD can be easily confused with other problems.

For practitioners who still don't know how to help children who don't fit society's mould, depression - the 'common cold' of mental illness - is perhaps the easiest dumping-ground diagnosis. The terrible cost of such an oversimplified verdict on our children is only just beginning to surface.

Pat Thomas


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