Forgive me for going over old ground, but I think it’s worth it – for all of us.
In March 2004, the then chief executive of the mental health charity MIND resigned from a government expert working group reviewing the safety of antidepressants, accusing it of negligence.
Richard Brook claimed the Medicines and Healthcare Products Regulatory Agency (MHRA) knew about concerns over Seroxat for 10 years but took no action. Mr Brook was a lay member of the working group investigating SSRIs, of which Seroxat is one, accused the MHRA – which licenses drugs for use in the UK – of failing in its duty by not acting on data showing that thousands of people were taking unsafe doses of Seroxat.
Mr Brook said at the time “On Thursday the MHRA at last published information advising that many thousands of men and women in this country may have been taking Seroxat at a dose that was unsafe.
What it failed to mention is that the regulator had the data on which the basis of this decision was made for well over a decade as part of the original licence application. Despite four major regulatory reviews during this period and considerable consumer reporting and disquiet, the Committee of Safety of Medicines failed either to identify or communicate these key facts. As far as I am aware, the MHRA has not seen fit to acknowledge or address what in my view appears to be extreme negligence. Either they didn’t understand the full implications of the available medical data at the time or, worse, that data was fully understood and they failed to act.”
The 18 month official inquiry into SSRIs, such as Seroxat, concluded in December 2004 that there was no evidence of increased self-harm and suicidal thoughts in adults. But Mind said it was concerned that the inquiry had not looked at the full data from clinical trials, but had relied on summaries handed over by the drug companies such as Glaxo.
Mind was right – not all the data had been seen by any means.
In February 2006 an excerpt from a previously sealed product liability report against GlaxoSmithKline (GSK) was made public. The medical expert report documented how the company systematically hid and manipulated data concerning Paxil-induced suicidality in depressed adults. The number of suicide attempts on the antidepressant Paxil was under-reported and the number of suicide attempts on placebo was inflated.
The entire product liability report is reproduced at www.breggin.com
Then in May 2006, in a move that had nothing at all to do with Dr Breggin’s report being made public just three months earlier, of course, GSK made a stunning admission. In a release in collaboration with the manufacturer GlaxoSmithKline (GSK), the FDA acknowledged the antidepressant Paxil caused a statistically significant increased rate of suicidality in depressed adults as measured in controlled clinical trials. Buried in the FDA/GSK release was an astounding fact: depressed people are 6.4 times more likely to become suicidal while taking the antidepressant than while taking a sugar pill.
But remember in December 2004 the expert working group concluded that there was no evidence of increased self-harm and suicidal thoughts in adults taking SSRIs…