Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label SSRi's MHRA. Show all posts
Showing posts with label SSRi's MHRA. Show all posts

Wednesday, March 12, 2014

MHRA Decline to Meet With Human Rights Movement






What is the difference between the British drug regulator, the MHRA, and the human rights movement, the CCHR?

Well, in short, the MHRA claim to protect us from unsafe drugs but...they fail on a grand scale whereas the CCHR continue to fight the corner of the small person on the street, trying to protect the health of the public by raising issues and questions to officialdom.

For those that don't know, MHRA stands for the Medicines Healthcare and products Regulatory Agency. Their job is to monitor the medicines the British public take. They are an agency that is fully funded by the pharmaceutical industry. Their Chief Executive is Dr Ian Hudson, a former World Safety Officer for GlaxoSmithKline [then SmithKline Beecham]

The CCHR stands for the Citizen's Commission on Human Rights. They have many purposes, two of which is to flag growing concerns regarding psychiatric drugs and those that prescribe them. They are a non-profit, non-political, non-religious mental health watchdog. Their UK's Executive Director is Brian Daniels who has no links to the pharmaceutical industry.

Back in July 2013 Brian, representing the CCHR, wrote to June Raine of the MHRA. He had previously wrote to the MHRA some months earlier but they had failed to respond.

The CCHR were concerned about the growing list of antidepressant 'adverse incidents' in the UK and proposed a meeting with the MHRA for an 'open debate'.

The CCHR even offered a database... "A set of data has been compiled consisting of 1637 incidents involving antidepressants. It has been made available on a web site www.antidepaware.co.uk. It came to the attention of this organisation as it aligned with documents gathered over decades regarding this category of drug and the adverse drug reactions."

Here's the letter in full.



The MHRA [eventually] replied in their usual classic fashion. They declined to meet with the CCHR citing the previous correspondence they had sent to the CCHR.

I've saw the correspondence, in fact, I have an uncanny ability to predict any correspondence from the MHRA when the subject of antidepressants are concerned... move over Doris Stokes. [1]

Here's the MHRA's bog-standard response they sent to the CCHR... they have sent me the same in the past.



So, 10 years ago, write the MHRA, an 'expert' working group published its findings regarding the balance and risks of SSRi antidepressant use. The 'experts', in relation to suicidal behaviour in adults, concluded that there was a modest increase in the risk of suicidal thoughts and self-harm for SSRis compared to placebo. They added that the MHRA follow up all cases of suicide that are reported to them. Reports can only be sent to them via their yellow card reporting system. 


I don't know about you but if I wanted to learn more about the quality of food served at a restaurant I'd ask a customer and not someone paid by the restaurant manager.

Ben Scott, who wrote the reply to the CCHR, lists himself as the MHRA's 'Customer Services Manager'.

Customer Services?

Nice job Ben. It must have taken you all of three minutes to copy and paste that to the CCHR. I wonder if MHRA clerical staff are given a typing test for such positions. I wonder if Ben, when filling out his application form for the customer services manager position, wrote, "I can type 40 words per minute". I bet my left nut it was met with senior management rolling around the floor laughing. "HAHAHA, guffaw, titter, this Ben chap seems to think we actually type our responses to customers, HAHAHAHAH, has he not heard of our standard stonewalling template?"

I don't mean to have a pop at Ben Scott here, he's probably a decent sort who believes he's working for an agency that really have their finger on the pulse of dangerous medications...even if that finger hasn't been lifted since 2004.

I've had many public spats with the MHRA. I've had meetings with them, I've been labelled by them, I think the term was  "loose cannon". Yeh, I'm a loose cannon, I fire when I need to fire and not when someone tells me to, least of all some lickspittle agency that bends over in front of the pharmaceutical industry merely to 'take one for the team'.

Men, women and children are killing themselves whilst taking antidepressant medication. It's no cause for concern for the MHRA because their 'experts' told us 10 years ago that the benefits outweigh the risks.

Here's what Facebook looked like 10 years ago.


Facebook, unlike the MHRA, have changed. Many, if not all of their changes, have come as a result of listening to what the customer wants.

The MHRA, have remained in the same position regarding their stance on the safety of antidepressants, it's a position highlighted in the following picture...




Take a good look at the picture. It shows two things. It highlights how the MHRA like to bury their head in the sand, at the same time sticking their ass in the air so the Pharmafia can politely butt-fuck them when they step out of line. [Ooops, there's the loose cannon in me rearing its wayward head]

If using profanity is what it takes for this agency to sit up and take notice about the huge SSRi problem then swear I shall.

I ceased communication with the MHRA a few years ago. I have, since, sent them a few minor requests. I publicly noted my reasons for severing my ties with them in my book.

The MHRA will not meet with the CCHR because they don't want the cold, hard facts thrown at them. They don't want to have to go back to the issue of the safety and efficacy of antidepressants because by doing so it will highlight just how utterly incompetent they are as an agency. They don't want their 2008 investigation into GSK rehashed because it embarrasses them greatly. In brief, the MHRA carried out a four year investigation. 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. Despite finding that GSK HAD been slow in releasing this information, the MHRA decided not to prosecute them. Instead they opted to send them a letter asking them not to be naughty again. [GSK really took heed of that 2008 warning huh?]

In the words of Charles Medawar, "They [MHRA] have failed and they have failed miserably"


Bob Fiddaman



[1] Doris May Fisher Stokes, born Doris Sutton, was a British spiritualist and psychic medium.








Friday, February 14, 2014

MHRA - "Your Views Matter"



I think it's safe to say that I, over the years I've been writing this blog, have had a lot of correspondence with the British drug [ahem] regulator, the MHRA.

Most of my correspondence with them, at least 80%, has been bog standard replies that they send out to anyone questioning their stance on antidepressants. I've publicly chastised them on here and in my book many times. Had a meeting with their CEO and met other officials on numerous occasions both in London and Birmingham.

Thing is... they've never really invited me to leave any comment about how I rate their performance.

Imagine my surprise then when I learn that they are now offering that service to members of the public who request information from them.

The MHRA Customer Services Feedback, aptly run via the surveymonkey website, invites you to leave comments regarding their performance of answering requests you have made to them. Hmmm, they have never offered me any such link in any of the emails they have sent me.

Anyway, why look a gift horse in the mouth. Armed with a snipping tool I've filled in the forms on the survey and added them as jpgs for your perusal.

The MHRA recently appointed a new CEO. His name is synonymous with Paxil litigation. Dr Ian Hudson took over the helm from Kent Woods last year. Hudson had previously been depositioned by US Attorneys in a Paxil suicide case. You see, the man who is now head of the MHRA once worked at GlaxoSmithKline, moreover, he was head of World Safety at GSK [Then Smith Kline Beecham] and worked closely with Paxil.

Nice to have some impartial at the head of a drug regulatory agency, huh?

Hudson, unlike Woods, chooses not to correspond directly with consumers [stakeholders], instead emails are answered by other employees at the MHRA.

Anyway...I've wrote about the conflict of interests at the MHRA many times before. Back to the The MHRA Customer Services Feedback.

Here's my feedback...









Bob Fiddaman

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 - More on the Mysterious "Ghost Specialists" 


UK Drug Regulator [MHRA] Cosy Up to Sir Andrew Witty

Pfizer team up with the Medicines and Healthcare Products Regulatory Agency

MHRA: Disrespectful, Uncaring or just Downright Liars?

MHRA Described As "Toothless Watchdog

SEROXAT - The Legal Questions that must be answered

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money

MHRA Consultant Calls for Antidepressant Use in Young











Friday, January 13, 2012

SSRi Birth Defects




An article in today's Daily Mail confirms what's been known for some time, at least by those in the know. The British drug regulator, the MHRA, seem to be ignorant on this matter or just prefer to bury their heads in the sand about it.

The Daily Mail's Jenny Hope opens her article with:


Women taking antidepressants such as Prozac during pregnancy are more likely to give birth to children with life-threatening high blood pressure problems, researchers say.


They found that the risk doubles among those taking selective serotonin reuptake inhibitors – the most heavily prescribed antidepressants – in late pregnancy.

I'm pretty passionate about this issue. I've made many friends during my time writing this old blog of mine, many of whom have first hand experience of SSRi related birth defects.

The Daily Mail has published something today that needs to be highlighted. A warning on a packet of pills claiming that taking a pill during pregnancy benefits any risk is merely a smokescreen to the real problem - a weak regulator who cannot/will not acknowledge the teratogen link in SSRi's.

The article mentions a study carried out by researchers at the Centre for Pharmacoepidemiology at Karolinska Institutet in Stockholm Sweden, who reviewed 1.6 million births in total between 1996 and 2007 in five Nordic countries: Denmark, Finland, Iceland, Norway and Sweden.

The study analysed several drugs, including Prozac and our old friend Seroxat, and findings showed that out of 11,014 mothers who used antidepressants in late pregnancy, 33 babies (0.2 per cent) were born with persistent pulmonary hypertension after assessment at 33 weeks.

SSRi birth defect litigation is rife in the US, to my knowledge no such litigation has been started in the UK. It's a sad state of affairs that women and infants have no protection from the UK drug regulator, an example of which becomes apparent when you read the classification of Seroxat in the US.

In the US, Paxil [Seroxat] is classed as a 'Class D' drug. This classification was given by the Food and Drugs Administration [FDA] - The FDA are the American equivalent of our MHRA. [Fig 1]

Fig 1


Furthermore, I have wrote to Seroxat manufacturers GlaxoSmithKline and asked them if Seroxat was a teratogen, their answer?

"GlaxoSmithKline works within the guidelines set out in the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI). This does not allow us to provide advice on personal medical matters to individual members of the public so that we do not intervene in the patient/ doctor relationship by offering advice which properly should be in the domain of your doctor. We would therefore recommend you discuss your concerns with him or her."

The same question was put to the MHRA, their response could only be described as toothless. They would not admit, one way or the other that Seroxat was teratogenic. Their full response is in my book, The evidence, however, is clear...the Seroxat scandal.

I posed this question to both GlaxoSmithKline and the MHRA because items of interest were aired in a US birth defect trial regarding Seroxat.

This from the Kilker v GlaxoSmithKline Birth Defect 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.

Court documents from the Kilker v GlaxoSmithKline trial, where Glaxo were found guilty of Seroxat being the causation of Lyam Kilker's heart defects, can be found HERE.

Only in America folks.

I get many hits from America on this blog, for those wishing to seek action against pharmaceutical companies who have knowingly put their infants at risk, I suggest the following websites where advice can be sought.

Antidepressant Birth Defects

Prozac Birth Defects

Celexa Birth Defects

Lexapro Birth Defects

You will learn that Baum Hedlund report far more birth defects related to SSRi drugs, defects not mentioned in today's Daily Mail article.

If any British law firms show an interest then I'll big them up on this blog too. Sadly, litigation against pharmaceutical companies in this country is proving to be extremely difficult. The MHRA's failure to acknowledge the teratogen link is proving to be pharma's 'ace up the sleeve'.

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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