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Tuesday, January 10, 2012

MHRA Described As "Toothless Watchdog"

MHRA described as "toothless watchdog"


Today's Mail Online is running with an article which describes the British drug regulator as a "toothless watchdog."

The article refers, in the main, to the MHRA's lack of response regarding the silicone breast implant ruptures, a story which I highlighted HERE on the 2nd January.

John Naish's brilliant piece highlights the incompetence of a regulator put into place to help protect the public and it's refreshing to see a journalist raising their past failings.

Naish writes:

Sadly, this is not the first time the agency has been criticised for acting slowly and ineffectually.

In September 2010, for instance, the diabetes drug Avandia was finally banned in Britain after the European Medicines Agency ruled there was a serious risk it could lead to heart attacks or stroke.

Evidence against Avandia had been building since 2007.

And, while denying it had failed to reveal the risks when they showed up, in July 2010 the drug’s maker, GlaxoSmithKline, reportedly paid out £304 million in damages to settle about 10,000 patient lawsuits in the U.S.

However, in the same month an advisory body to the MHRA warned it that the ‘risks (of Avandia) outweigh its benefits, that it no longer has a place on the UK market’ and called for prompt action.

The MHRA did not reveal this warning to the public; it simply passed its information on to European authorities. A few years earlier, media pressure was required to force the MHRA to act over another prescribed-drug danger. Again, it was a GlaxoSmithKline medicine — the antidepressant Seroxat.

Specialists had been warning for years of the raised risk of suicide in children. But the MHRA, relying on evidence from the manufacturer, issued assurances that there was no suicide link.

AMEN BROTHER NAISH!

On the subject of the Seroxat debacle the MHRA claimed, "...it wanted to require drug makers to share more information about clinical trials — but admitted that, without stronger legislation in place, there was no chance of prosecuting the company for what it called an ‘ethical lapse’."




lapse
noun  
A temporary failure of concentration, memory, or judgment.



Glaxo must have been victims of their own product as concentration, memory and judgement are all impaired when taking Seroxat...that's probably why kids have killed themselves whilst taking it!

For the MHRA to even suggest that the suppression of clinical trial evidence was just a lapse smacks of a body of ancient freemasonary types whose fingers are either in the pharmaceutical pie or who are just too scared to speak up against the very same industry that fund them.

It's fair to say that I'm not one of the MHRA's biggest fans, nor they mine. In my book, The evidence, however, is clear, the Seroxat scandal, I write about my past correspondence with the MHRA Chairman, Kent Woods and his failure to accept that Seroxat is a known teratogen. Evidence supplied to the MHRA [taken from disclosure in the Kilker v GlaxoSmithKline trial] failed to alter their stance on whether Seroxat was a proven teratogen.

This from the Kilker trial: 

Doctor Sloot's paper demonstrated that Paxil [Seroxat] was a clear teratogen, that it was not just an effect of developmental or birth-weight related effect, that it was a direct teratogen, and that there was a spectrum of defects observed in rat embryos at low doses, establishing that it was a very potent teratogen, more teratogenic than cocaine and retinol, clear teratogens in their own right.

Furthermore, the MHRA have recently sent out an SSRi Learning Module to healthcare professionals in the UK. They have recommended to doctor's that any patient suffering severe SSRi withdrawal should be referred to a 'specialist'. On asking the MHRA exactly who these 'specialists'' were, they could not answer me. Further probing resulted in the MHRA telling me that they would not answer any more questions on the subject.

Boo Hoo!

In truth, these 'specialists' don't exist and it appears the MHRA have shot themselves in the foot by suggesting that they do.

I've labelled the MHRA 'limp-wristed' in the past, 'toothless watchdog' seems so much better.

Read John Naish's article in full HERE

Related:


Another Boob From the MHRA

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

MHRA In Buck-Passing Specialist Cahoots

MHRA - More on the Mysterious "Ghost Specialists"

MHRA Wishing To Call The Shots



Fid


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE


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