So popular, it鈥檚 in our water (Image: Steven Taylor/Getty)
YOU may never have heard of it, but Study 329 changed medicine. It was the first trial to highlight serious problems with a common class of antidepressants, but only now have the full results been opened up to independent scrutiny. They show that one drug is even more likely to trigger suicidal behaviour than we thought.
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Study 329 looked at paroxetine, one member of a family of antidepressants, the selective serotonin reuptake inhibitors (SSRIs) 鈥� once described as wonder drugs. When the study took place in the 1990s, these drugs were only approved for adults, and pharmaceutical firms were looking to extend their use to teenagers.
The first paper from the trial, , involved 275 teens with depression. It concluded that paroxetine was generally well tolerated and had similar side-effect rates to placebo pills.
But by then several US lawsuits were under way, involving adults who had become suicidal or violent soon after starting these types of drugs. Paroxetine manufacturer GlaxoSmithKline later released trial reports revealing that teens in the study had higher rates of self-harm and threatening to commit suicide than those on placebos.
Now GSK has given independent researchers access to the study鈥檚 data set. Sifting through it, , a psychiatrist at the Hergest Unit in Bangor, UK, and his team found 15 instances of suicidal behaviour among 12 teenagers taking the drug, compared with four in the similarly sized placebo group (). The company鈥檚 trial reports had suggested only 10 instances in those taking paroxetine.
In a statement, GSK said product labels have, for more than a decade, carried clear warnings about the increased risk of suicidal behaviour in adolescents. 鈥淎s such, we don鈥檛 believe this reanalysis affects patient safety.鈥�
But the findings show that only with all the figures can the risks and benefits of medicines be weighed up, says Healy. 鈥淭his is alarming for anybody who takes any pharmaceutical drug.鈥�
He doesn鈥檛 claim that teenagers should never take SSRIs, rather that these drugs be reserved for severe depression, and that we should be alert to the side effects.
In some of the UK鈥檚 poorer areas, one in six people is on an SSRI, and traces of Prozac have turned up in the water supply. So SSRIs remain in wide use despite the fact that, since GSK released its trial reports, other research has cast doubt on this group of medicines. Only this week, a study found that under-25s taking them are more likely to commit violent crime ().
A major review in 2008 showed that SSRIs work for mild depression. Tim Kendall of the Royal College of Psychiatrists in London says a large body of evidence now shows talking therapies like cognitive behavioural therapy should be the first port of call in depression, especially for those under 30.
To GSK鈥檚 credit, the firm is the only drug company so far signed up to AllTrials, a campaign for disclosure of clinical research data (see 鈥�Only full disclosure of drug trial results will maintain trust鈥�).
However, Healy says that the company still makes it difficult for researchers to search and analyse its data. 鈥淚f we don鈥檛 have full access to the raw data we can鈥檛 make out what鈥檚 going on.鈥�
Leader: 鈥�Only full disclosure of drug trial results will maintain trust鈥�
This article appeared in print under the headline 鈥淣ew look at happy pill鈥檚 downside鈥�
