You’d think it is enough of a scandal that doctors are prescribing powerful antidepressants to two-year-olds, but now we’re told that one pharmaceutical suppressed findings that the drugs weren’t even working.
It’s been announced this week that GlaxoSmithKline, the UK’s largest drug company, avoided publishing the data because it was concerned the findings would affect its lucrative adult market for the drug.
Two major clinical trials, codenamed protocols 329 and 377, tested Seroxat (paroxetine) on a group of children and adolescents with major depression and found that the drug was no more effective than a placebo, or sugar pill.
Despite these findings, GlaxoSmithKline was also aware that the drug caused suicidal tendencies, especially among the young.
The full findings of the studies, which were carried out in 1998, came to light only last spring when the UK regulator, the Medicines and Healthcare Products Regulatory Agency, banned the drug for use among children because it was ineffective and unsafe.
The revelation is but the latest twist to a scandal that is worrying regulators in the UK and the USA. America’s drug watchdog, the Food and Drug Administration, has finally agreed to review the practice of prescribing antidepressants to children. The drugs are not in any event licensed for use among children, but doctors are free to prescribe them if they feel it is an appropriate therapy.
As we outlined in E-news 58, around 2 per cent of all youths in the USA are prescribed an antidepressant. This unlicensed usage increased by 400 per cent between 1988 and 1994 alone.
The FDA has conceded that the drugs are more likely than placebo to cause suicidal thoughts, although nobody knows how many children have attempted or committed suicide while taking an antidepressant.
We recall an encounter we once had with Dr Thomas Stuttaford, the medical correspondent for the London Times. ‘The trouble with you (What Doctors Don’t Tell You and all like us),’ he said, ‘is that you don’t realize that when you have a sharp sword (an effective drug), some heads will be cut off (there will be adverse reactions).’ It appears that blunt swords can also decapitate, too.
(Sources; The Guardian, 3 February 2004; Journal of the American Medical Association, 2003; 290: 1033-41).