It seems uncanny that the first ever post on this blog, back in 2006, was to highlight the failings of the MHRA. Over three years has passed since that first post, 3 years, 7 months, and 16 days, 1,326 days, to be exact.
I was quite shocked when I worked this out. I've been writing for that length of time about something I am passionate about. I don't get paid for what I write, quite a lot of man hours put in for voluntary work one would think.
During these 3 years, 7 months, and 16 days the MHRA have investigated the safety and efficacy of Seroxat and other SSRis/SNRi's. Each time, they have concluded, that the benefits outweigh the risks.
On the 6th March 2008, the MHRA issued a press release, 'GSK investigation concludes'
Part of that statement reads:
The MHRA has concluded its four year investigation into Glaxosmithkline and its antidepressant drug Seroxat. The investigation focused on whether GSK had failed to inform the MHRA of information it had on the safety of Seroxat in under 18’s in a timely manner.
The investigation was undertaken with a view to a potential criminal prosecution for breach of drug safety legislation. It was the largest investigation of its kind in the UK, and included the scrutiny of over 1 million pages of evidence.
The decision taken by Government Prosecutors, based on the investigation findings and legal advice, is that there is no realistic prospect of a conviction in this case, and that the case should not proceed to criminal prosecution.
It continued with:
Professor Kent Woods, MHRA Chief Executive, said: “I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients, and should report any adverse data signals to us as soon asthey discover them. This investigation has revealed important weaknesses in the drug safety legislation in force at the time.
It is interesting to note that the deflection away from the behaviour of GlaxoSmithKline is directed toward the drug safety legislation in place at that time.
It is also interesting to note that in the four paragraph press release the MHRA choose not to chastise GlaxoSmithKline.
I, along with others, was never happy with the way this investigation was handled and, as with others, I made my feelings clear on this blog and in various other forms of communication with the MHRA. It was, however, something that I and others had anticipated.
The one chance at a criminal prosecution being brought against GlaxoSmithKline, scuppered by an antiquated drug safety legislation. To put it into layman's terms, The MHRA and GlaxoSmithKline had squared up for a fight in the ring. GlaxoSmithKline won on points. There was to be no re-match.
The response from GSK into the MHRA's conclusion of this 4 year investigation was more like a 'thank you' note if one reads between the lines. It smacked of smugness and a severe lack of conscience.
Both the MHRA and GlaxoSmithKline rode the storm that ensued, "Today's newspaper is tomorrow's fish and chip paper."
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
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