How could the expert working group have got it so wrong? Maybe Charles Medawar at Social Audit can help us to understand.
When the UK drug regulators, the MHRA, ran their ‘independent’ investigation of SSRI antidepressants, in 2003-4, they relied not on the raw data, but on summaries and analyses the manufacturers had prepared, which are what the expert working group examined.
The limitations of this approach are evident from Social Audit’s correspondence (start here) with the MHRA about the true nature of the so-called ‘placebo suicides’ reported in paroxetine-versus- placebo clinical trials. Briefly, both the MHRA and the European regulators (EMEA) accepted Glaxo’s claim that, in these trials, three people on placebo committed suicide, compared with only one person on paroxetine. This was a key finding and central to the regulators’ enquiries, but an inherently implausible result. Moreover, it was based on brief summary evidence provided by a company, Glaxo, that was then (and still is) under investigation for suspected concealment of related evidence. Nevertheless, EMEA, the MHRA and its Expert Working Group saw no need to examine the raw data – and this raw data that demonstrates that the three ‘placebo suicides’ were no such thing.
You can jump into the Social Audit’s correspondence at a later point here but prepared to be shocked at the way the MHRA abuses the Freedom of Information Act to withhold what it considers ‘personal information.’ You’ll also be shocked at the lack of interest the MHRA has about telling the truth.
I’m really not sure whether to be more afraid of the MHRA or of Glaxo. This is by no means over yet – I’m sure that in the not too distant future we’ll all learning more about this episode.
Last words (at the moment) to Charles Medawar: “This whole episode leaves me feeling that the MHRA is absolutely not to be trusted and that something of a culture of mendacity seems to prevail.”