Drug firms accused of preying on children

Doctors are prescribing antidepressants to children and adolescents based on exaggerated claims of their benefits from studies tainted by drug company funding, says a leading psychiatrist.

Jon Jureidini analysed the results of several published surveys comparing children prescribed drugs like Prozac, Aropax and Zoloft with those who took a placebo, and concluded severe side-effects - including the possibility of triggering suicidal behaviour - had been downplayed by scientists.

Dr Jureidini found one study of Aropax, of which its authors claimed "most adverse events were not serious," included seven patients who had to be put in hospital. A study of Zoloft described it as "an effective, safe and well tolerated short-term treatment for children and adolescents", despite dangerous side-effects that occurred twice as often as in children taking the placebo.

Where the studies showed some benefit, it was very slight and unlikely to make a difference in the real world, wrote Dr Jureidini, the head of the department of psychological medicine at Adelaide's Women's and Children's Hospital, in the British Medical Journal. He blamed the involvement of the drugs' manufacturers in the trials.

His analysis comes amid mounting international concern about the safety of the new generation of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) in childhood and adolescence. The Federal Government issued interim advice to doctors a month ago to prescribe them very cautiously with rigorous follow-up of patients, pending the results of a US government review that is expected to outline whether they are safe. British health authorities have already ruled Prozac is the only SSRI safe enough for depressed children.

The principal medical adviser of the Health Department's Therapeutic Goods Administration, John McEwen, said it would be months before the final advice became available. He emphasised none of the drugs were formally licensed to treat childhood depression and that the Government already recommends two brands - Aropax and Efexor - not be used on children.

Louise Newman, chairwoman of the faculty of child and adolescent psychiatry of the Royal Australian and New Zealand College of Psychiatrists (RANZCP), said Dr Jureidini was right to point out there was not enough evidence to back the use of antidepressants in children. "He makes a very valid point that non-pharmacological treatments have a very good evidence base," Dr Newman said.

But she cautioned against "simplistic" prescribing rules, saying there would always be cases where drugs were needed.

Dr Newman said the RANZCP had recommended to the TGA that children prescribed antidepressants by a doctor "as soon as practically possible should be reviewed by a child psychiatrist or a pediatrician".

Ian Hickie, clinical adviser to the national depression initiative, beyondblue, said early hopes SSRIs would work well in children's depression had been largely unfulfilled, though they had an important role in treating some other conditions - such as obsessive compulsive disorder - during childhood.

But he agreed with Dr Newman that they were sometimes needed. "If you've got a depressed and suicidal adolescent, doing nothing is not an option either," Professor Hickie said.