MHRA – too little, too late: once again

I’ve just read the new SSRI Learning Module on the MHRA website – the MHRA says “it’s for medical, nursing and pharmaceutical professions, and is suitable for those nearing the end of their formal training or those who have recently completed such training. Also, health professionals will find the module a helpful refresher, for example, at the start of a posting in clinical psychiatry.”

I was looking forward to reading something that I thought would bring healthcare professionals up to date on the dangers of SSRIs and so position the MHRA firmly on the side of patients.

In reality the learning module reads like something a pharmaceutical company would write – you know, like a more detailed Patient Information Leaflet (the leaflet you get in the box with your tablets). Nothing wrong with that I suppose, except from my experience, the PIL really played down the many strange side effects and horrible withdrawal I endured for almost two years – and as it was written by a drug company – about one of its own products – you would hardly expect otherwise.

An interesting point about the Seroxat PIL, for example, is the way it has ‘developed’ over the years – as GSK has been unable to hide the truth from the public over the years, so it has had to rewrite the PIL – have a look at all the different versions here and compare the very first one with more recent versions.

Blockbuster drugs earn pharmaceutical companies billions and billions in pure profit and so the ‘reputation’ of a drug is carefully built and jealously protected.

The truth doesn’t get a look in.

This can also be true of the clinical trials that the drug companies use to get their licences in the first place – perhaps you didn’t know that the drug trials that don’t produce the ‘right’ results (ie positive) for a drug are simply hidden or the trial is abandoned.

Bad results are buried, as there is no law that says drug companies have to submit the data from ALL the trials they undertook. However some trials are needed to submit with licence applications, so sometimes, as in the case of study 329 for Seroxat, the trial is published but the results are misinterpreted in a way that show the drug, Seroxat in this case, to be safe and very effective, when the opposite was actually true.

Anyway, back to the learning module. As I said it reads like something a pharmaceutical company would have written… And then I noticed this line “…This learning module is derived largely from summaries of product characteristics (which, in turn, are based on rigorous evaluation of submitted evidence)….”

And you know who writes the “…summaries of product characteristics…” don’t you?

And you know who submits the evidence [always positive], don’t you?

And you know who undertakes the rigorous evaluation, don’t you?

I think you may have got there ahead of me – the summaries of product characteristics are written by the Marketing Authorisation Holders, who just happen to be… The drug companies… that make the drugs – that rig the trials – that write the PILs – that hide the negative data – that make the billions.

The truth doesn’t get a look in.

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