A BMJ study has highlighted serious flaws in a trial published by GlaxoSmithKline, that found the drug paroxetin – marketed as Seroxat and Paxil – was ‘generally well tolerated by children with depression
September 15, 2016
Now a new study in the BMJ has gone back over this trial and highlighted major flaws, showing the extent to which doctors and patients were misled.
Australian researchers point out that the drug was no more effective than a dummy pill and that the increased risk of harms was ‘clinically significant.’
They also highlight how the trial was actually typed up by a medical writer hired by GSK while another of the senior scientists involved was under investigation by US authorities for his ties to drugs firms.
The editor of the BMJ Fiona Godlee said the case ‘shows the extent to which drug regulation is failing us’.
Although this took place some time ago, she said many drugs firms routinely overstate the benefits and underplay the side effects in trials in their treatments.
This includes trials for statins and she said too little had been published about the potential harms of these cholesterol-lowering pills.
On top of this, there are also concerns that many of the scientists involved in these medical trials are being paid by the drugs firms to carry out other work or attend conferences and dinners.
She said: ‘This long running saga has within it all the seeds of our current discontent – industry malpractice, paid opinion leaders twisting the results of trials, hidden data allowing manufacturers, academics and clinicians to overstate the benefits and underplay the harms of treatment.’
The BMJ study found the drug – which was prescribed to two million children in the US off the back of the GSK study in 2001 – was no more effective than a dummy pill and the risk of harm was ‘clinically significant’
GSK was fined a record £2 billion by a US court in 2012 wrongly promoting Paxil between 1997 and 2004 in what was described as the biggest fraud in American healthcare history.
The offences included paying US doctors to attend dinners, lunches, spas and pheasant hunting trips where the treatment was heavily promoted.
The treatments are not widely offered to children and teenagers now and there are clear safety warnings on their packets.
A spokesman for GSK said: ‘We were able to help this team to carry out their reanalysis by providing access to the detailed data from the original trial.
‘This reflects our commitment to data transparency – we publish the results of all our studies regardless of whether they are positive or negative.
‘Importantly, the findings from this team’s analysis appear to be in line with the long-standing view that there is an increased risk of suicidality in paediatric and adolescent patients given antidepressants like paroxetine.
‘This is widely known and clear warnings have been in place on the product label for more than a decade. As such we don’t believe this reanalysis affects patient safety.’