MHRA Come Under Fire From Lancet Editor

 "The operating principle of the MHRA seems to be to do nothing until something goes wrong." -  Richard Horton  The Lancet.

Far be it for anyone to criticize the failure of the UK medicines regulatory agency...they may be labelled vexatious - However, this does not seem to have deterred the editor of The Lancet, Richard Horton.

In an article published in today's Independent, Horton states, "The operating principle of the MHRA seems to be to do nothing until something goes wrong."


His scathing attack comes after Health Secretary, Andrew Lansley, announced last week that there was to be a review of the regulation of medical devices.

Don't hold your breath folks, the MHRA have been criticized for years, they are still in place, still safeguarding human health by monitoring drugs, such as suicidal Seroxat and devices such as substandard breast implants, both of which they were warned about, both of which they did nothing about.

I echo what Richard Horton said although I'd add that even when they [MHRA] do realize something is wrong...they do nothing about it, apart from hold safety reviews with panels of industry-tied relics who tout that benefits outweigh risks...without actually ever trying out the products they review.

The scathing attack from the editor of The Lancet can be seen in full HERE.

Incidently, two questions tabled in parliament today which the MHRA have fence sat on for many years:

Eric Ollerenshaw (Lancaster and Fleetwood): To ask the Secretary of State for Health, what warnings his Department has issued on possible teratogenic effects of the use of benzodiazepines; when such warnings were issued; and on what scientific evidence they were based. 

 and

Eric Ollerenshaw (Lancaster and Fleetwood): To ask the Secretary of State for Health, whether his Department has assessed Seroxat [paroxetine] as being teratogenic. 

I fully anticipate that  the Secretary of State for Health shall contact the MHRA and be given the runaround in his search for the truth.

In the meantime, here's some more evidence of the British regulatory agency causing annoyance. [vexatious].




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


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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


AUSTRALIAN ORDERS HERE

Another Boob From the MHRA

2012 sees the MHRA bowing to public pressure [once again], this time over breast implants.

For years they have fence sat [unsurprisingly] with regard to the safety of breast implants made in France  and filled with gel meant for mattresses.

Figures suggest that the MHRA have downplayed the chance of rupture with the implants, in fact, down played by as much as eight times!

Today's Mail Online reports that silicone leaks from the implants are causing agonising pain as well as swelling and lumps under the armpits. Fears have also been relayed that the implants may increase the risk of cancer.

The Mail online writes:

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has been accused of playing down the dangers. Over the last fortnight it has repeatedly urged women not to panic, simply saying that anyone who was worried should contact her surgeon. While it banned further use of the implants, it said that there was only a 1 per cent chance of rupture, compared with a 5 per cent rate reported in France.

But on Friday night the MHRA received new data from one of Britain’s biggest chains of plastic surgery clinics. This placed the rupture rate at around 8 per cent, although it was not clear if the figure applied to patients or to individual implants.

The MHRA have recently slammed the door closed on a line of questioning I put to them regarding apparent SSRi withdrawal "specialists" that they claim exist in the UK. Upon asking them for the names of these "specialists" they, more or less, stonewalled me and told me that they would not answer any more of my questions on the subject.

No problem, I can still speculate, can't I?

I'm left wondering if the MHRA only act when reports of dodgy medical devices, drugs and/or vaccines hit the mainstream press. Their house was supposedly put in order when BBC's Shelley Jofre exposed them in a Panorama documentary and it was only with mounting public pressure that they investigated GlaxoSmithKline for suppressing clinical trial evidence relating to Seroxat - the findings of that investigation were what we already knew, the action taken by the MHRA was to send GlaxoSmithKline's, then CEO, JP Garnier, a "You've been a naughty boy, don't do it again" type of letter.

So, now it appears that the MHRA have received "new data" regarding the breast implant debacle.

One has to ask why the British drug regulator are, seemingly, always last to hear about the dangers of drugs or devices. An agency put in place to monitor the safety of drugs/devices should not only be alert, they should also alert the people they were put in place to protect. The post-marketing surveillance team at the MHRA are clearly unable to do their job...it's left to the British press and/or bloggers to give the MHRA the proverbial kick up the backside.

They are supposed to be a watchdog, I think pharmaceutical lapdog would be a more appropriate term.

Related:


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


AUSTRALIAN ORDERS HERE