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Mental health

Rules on medicines 'need big shake-up'

Anti-depressant ban for children reveals flaws in system, says Mind

Sarah Boseley, health editor
Thursday December 11, 2003
The Guardian

There were calls yesterday for an independent review of the regulation of drugs in the UK, following the banning of most modern anti-depressants from use in children some years after pharmaceutical company trials showed up a problem.

Mind, the leading mental health charity, said the regulatory process was fundamentally flawed and needed to be overhauled if consumers were to have any confidence in it.

"It is totally unacceptable that for a significant period 50,000 children and adolescents in the UK have been prescribed anti-depressant drugs that were not licensed for use but it is only now being demonstrated that they do not help and can indeed cause harm," said Richard Brook, Mind's chief executive.

"The loud voices of users and a high profile campaign started a course of events that led to [Tuesday's] announcement. Long-term, effective and strong regulation has not been evident or provided the type of information consumers have the right to expect."

As the Guardian revealed yesterday, four antidepressants of the selective serotonin reuptake inhibitor (SSRI) class were effectively banned from use in children by the Medicines and Healthcare Products Regulatory Agency: Lustral (known as Zoloft in the USA), Cipramil, Cipralex and Faverin. Two others, Seroxat and Efexor, were banned earlier this year. None was licensed for use in children, but doctors can prescribe unlicensed drugs if they feel it is appropriate.

The MHRA reached its decision after an expert working group reviewing the SSRI class of drugs was given access this year to the full trial results of some in children. Although these were carried out in the mid to late-1990s, the full data had not been given to the MHRA. These showed that more children and adolescents became suicidal on the drugs than on placebos (sugar pills).

The review of the SSRIs was only set up at the end of last year because of mounting public pressure, following allegations that people became hooked - unable to stop taking them without suffering severe withdrawal effects - and in some cases suicidal.

"There are enormous commercial interests trying to influence decisions about the use of drugs," said Mr Brook. "Pharmaceutical companies represent the second largest industry in the UK. The public needs to have confidence that their health is being properly protected - particularly where children are concerned."

The companies are not happy with the MHRA ruling. Pfizer, which manufactures Lustral, said in a statement: "Pfizer disagrees with this guidance based on a thorough review of our clinical trial database ... Pfizer believes that the robust clinical programme involving sertraline suggests no increased risk of harm to any population, including children and adolescents."

One drug from the SSRI class, Prozac, has not been banned, but the psychopharmacologist whose researches started the concerns over suicides said yesterday that the trial data in children did not show it was superior in safety or efficacy to the others. David Healy, director of the North Wales department of psychological medicine, said there had been two trials of Prozac in children - one reported in 1997 and the second in 2002. The drug's performance in the first showed little effect.

In the second trial, however, although Prozac did not lift children's depression more effectively than the other SSRIs, it scored better because the children in the comparison placebo group did not do as well as in trials of other drugs.

And yet, said Dr Healy, "the adverse event [side effect] profile was worse on Prozac than on placebo. In the Prozac group of trials there were four suicidal acts among children and zero on placebo."

There is some concern now that children on SSRIs will be switched by doctors to Prozac, when the best alternative for most would be non-drug therapy. Mind said yesterday, however, that there is a shortage of professionals trained in other approaches which can help in depression. Mind and the MHRA say it is important for children on SSRIs not to stop taking them suddenly, but to consult their doctor.

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