GSK’s lead barrister on ‘RIVAL pharmaceutical companies’: will the ‘Seroxat is defective’ trial erode the reputation of all SSRIs? Preview of week 2. (Plus day 4 – adjourned for a month)
On day two of the trial, I suggested there were indications of ‘a strategy [by GSK] to make [Dr David] Healy appear unreliable’.
But on day three a more complex picture emerged. Right after suggesting a ‘benefit’ of Seroxat was its high number of licensed indications, Mr Gibson QC focused on ‘fluoxetine…[which] because of its long half life is not recommended for patients who require a rapid antidepressant effect.’
Fluoxetine (Prozac) was made by ‘Eli Lilly’, who compared it to paroxetine and other antidepressants, but these were ‘almost all short-term interruption studies…fluoxetine has a much longer half life so it follows as night follows day that the patients on fluoxetine are still effectively in treatment’.
This sounded exactly the kind of point David Healy would make: a manufacturer uses a study design which favours its own drug, and handicaps the competition.
‘The claimants in fact rely on a tiny number of studies…almost all conducted by other pharmaceutical companies…RIVAL pharmaceutical companies’.
Mr Gibson even alluded to cases David Healy had been an expert witness for in the United States, involving fluoxetine and other SSRIs.
Next up was venlafaxine, although if he mentioned the company (Wyeth, now part of Pfizer), I missed it. It behaves as an SSRI at lower doses, but differently at higher doses and is as toxic as older tricyclics in overdose: ‘Professor Healy DOES consider that venlafaxine is to be included’ in the comparator group, Mr Gibson stressed.
And the drug which overtook them all as market leader in the 2000s, citalopram, was favoured in ‘the Baldwin papers…all sponsored studies by Lundbeck’. It later turned out to cause cardiac problems, with ‘an increased risk of sudden death’, a point which was repeated.
Mr Gibson did not spell it out, but the implication was that if you had a patient who needed rapid treatment, was a high risk of suicide, and had a heart problem, then the SSRI options were narrowed to fluvoxamine, sertraline and paroxetine. Three ‘rival’ drugs down, two to go.
He also mentioned that ‘sadly’ some patients needed ‘maintenance treatment’, preparing the ground for a relatively frequent and severe ‘discontinuation syndrome’ not always being a major ‘defect’.
The issue of publication bias hung in the air, although no one actually used that term. The judge asked if it would have been ‘realistic’ to obtain all the comparative data from other companies, to overcome the ‘rival companies’ distortion of the evidence available to the trial.
No, replied GSK’s barrister, adding that this was another reason why the claimants’ case was ‘flawed’.
So he was coming very close to conceding the key overlapping points that David Healy has been making for two decades: individual companies will only release data and research which favours their product, and the psychiatrists (usually) who publish and present such research are not independent of commercial interests.
This is a civil trial, and even though all these drugs are out of patent, they are still making some money in branded products. Eli Lilly, Pfizer, Lundbeck et al would have no commercial interest in helping out GSK with their old unpublished data and research, which would be likely to have only a negative effect on their products’ reputations.
So next week, although GSK will want to undermine Healy concerning Seroxat, it appears they will be promoting him as a reliable witness on the various ‘defects’ (in the ordinary sense) of other SSRIs.
(Added Thursday 9th May)
Two and a half days were lost from the original schedule (see end of my day 3 report), and the there was a twenty minute hearing at 3 pm today.
The judge had made her ruling, presumably on ‘scope’. which the claimants were not happy with.
It seems strange to me that the public can attend a hearing where such a ruling is discussed, but are not provided with it. Very little was said about the content of the ruling or the nature of the claimants’ objections.
My understanding was that the claimants have an opportunity to make further submissions to the judge in the next four weeks.
If they appeal against the ruling, to the Court of Appeal, a decision could take up to a year.
If they decide not to appeal, the trial will resume on Wednesday 5th June at the earliest. This would disrupt the schedule: it was not spelled out, but it would seem unlikely that the trial would then finish before the summer break.
Apologies to any readers who have been left in a state of suspense. I have too.