3 YEARS ON... MHRA STILL DON'T MOVE

Over three years ago (April 19 2005) to be precise, Charles Medawar of Social Audit, sent Kent Woods, CEO of the MHRA, a rather detailed complaint regarding antidepressants and the MHRA. The complaint alleged maladministration by the Medicines and Healthcare products Regulatory Agency (MHRA).

The complaint specifically concerned the regulation of a class of antidepressant drugs collectively known as SSRIs (Selective Serotonin Reuptake Inhibitors). SSRIs have the notable advantage of low toxicity in overdose, but it is now generally accepted that SSRIs are no more effective in treating depression than other kinds of antidepressants. However, SSRIs have been marketed intensively, with the emphasis on promoting their use for an ever wider range of milder states of emotional distress.

SSRIs cause a wide range of adverse effects – e.g. weight gain, loss of libido, mood disturbances, and mental distress - but to illustrate this complaint reference is mainly made to the risk of drug withdrawal reactions indicative of drug dependence, and to the risk of SSRI-induced suicidal and violent behaviour.

It is generally relevant to this complaint, that a recent inquiry by the House of Commons Health Committee cast serious doubts on the fitness and competence of the MHRA. This Committee identified excessive and unwarranted drug prescribing as a real and growing danger to health, and questioned whether the Agency was equal to the task of containing it.

The Committee (para 376) thought not:

"During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust. Nor did we conclude that the MHRA provides the discipline and leadership that this powerful industry needs. We recommend that there be an independent review of the MHRA …"

You can read the complaint in full HERE

You can read Kent Woods response HERE

Charles Medawar responded to Woods with this letter HERE

It seems there was no correspondence after that.

Over three years ago and how far have we moved on?

Well, the MHRA had a meeting with patients. Withdrawal was glossed over.

At least Woods has agreed to read the thousands of complaints Janice Woods of the Seroxat User Group has collected over the years. I, myself, sent him a 172 page document with patient complaints about withdrawal - he never replied, in fact there has been no official reponse from the MHRA regarding that document I sent them. I also sent the MHRA a copy of the Glenmullen report. I have received no confirmation as to whether anyone from the MHRA have read it yet. Glenmullen's report confirms the opinion reached by psychiatrist Peter Breggin, MD, who submitted an expert report in another case in 2001.

I have to ask myself firstly why the MHRA are choosing to ignore the two documents I sent them. If they have read them then why not tell me? If they have an opinion on them then why not go public with it? Surely an opinion from a medicines regulator may put the public's mind at ease?

I hate to rain on the Seroxat User Group's parade but it is my opinion that whatever you send Woods [MHRA]will be glossed over and the psychological excuse will be touted.

Who do they believe?

The consumer or the manufacturer?

Their Chairman, Alasdair Breckenridge, thinks there is no Seroxat scandal: "The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish”.

Rubbish eh?

If it were rubbish why would your CEO sit down with patient representatives and discuss Seroxat? The meeting wasn't just about the MHRA investigation... at least I hope it wasn't.

Incidently, Alasdair Breckenridge resigned from GSK before working for the MHRA!

If Alasdair Breckenridge thinks the 'so-called Seroxat scandal is rubbish' then I think those patient representatives who attended the meeting with Woods completely wasted their time.

After all, the House of Commons Health Committee did say: "...the Agency seemed oblivious to the critical views of outsiders"

It seems the only thing to come out of the MHRA regarding Seroxat is 'absolute rubbish'.

Resources;

Social Audit
AHRP Blog
Seroxat Secrets


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


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