MHRA FAIL YET AGAIN

Please find below correspondence to which I was copied into by Dr Aubrey Blumsohn.

I was copied in on the email and in the spirit of openness I am reproducing it without permission and will be interested to receive a reply

Dr Blumsohn is apparently one of the brave few doctors who seems to care about honesty. There is some information about scientific fraud and ghostwriting about the drug Actonel (Procter and Gamble Pharmaceuticals) and the story of what happened to him seems unbelievable. It involved ghostwriting of science in Dr Blumsohn's name. The reported study findings subsequently seemed to be fraudulent. Having received no help from the MHRA, the Research Dean of his Medical School, Sheffield University and after a journal editor attempted to suppress the information (follow the money) he went to the press and was fired.
For more information on Dr Aubrey Blumsohn and what happened to him - click on the following links

http://www.slate.com/id/2133061/
http://www.thejabberwock.org/jbmrs.htm
http://www.whistleblower.org/content/press_detail.cfm?press_id=507
http://www.whistleblower.org/content/press_detail.cfm?press_id=387


Dr Blumsohn's letter follows



28th June 2006


Ms Susan KramerLiberal Democrat MP for Richmond Park

Steve Webb MPLiberal Democrat Shadow Health Secretary

Dear Ms Kramer/Mr Webb

I was sent correspondence from yourself and Steve Webb about the MHRA from constituents concerned about scientific fraud in studies of SSRI antidepressants. I am a medical doctor and have some personal experience of this duplicitous agency involving other drugs. I don't believe you understand the gravity or nature of the problem.

You state that "While this is being examined, I have signed EDM 100 (Prescription Medication), which calls for FULL AND IMPARTIAL INFORMATION for consumers on the potential risks and side-effects of prescription medication. "

With respect, the problem is not one of providing consumers with "full and impartial information", rather that there is no longer any "impartial information" to provide. Doctors, researchers, and authors fronting scientific papers about pharmaceuticals are also being denied information about the drugs they are prescribing, and manipulated "scientific" material is being written by companies as if it derived from University academics (such as myself). The regulators are seemingly accepting the information fed to them by companies with blind faith - with demonstrably catastrophic results.

Your Colleague Steve Webb stated

"I have looked at EDM 2172 and will not at this stage be recommending that my colleagues sign it. Clearly to accuse the MHRA of a cover-up needs to have pretty solid evidence that this is the case. As you have been taking up this issue through my colleague Susan Kramer, I would suggest that you ask her to write to the MHRA on the issue and give them the right of reply."

This is not a matter of fine politics or "rights of reply" - at least 50,000 patients are estimated to have died in the US alone as a result of cover-ups and scientific fraud involving VIOXX. Scientific fraud involving SSRI's has almost certainly resulted in deaths and much suffering.
The evidence suggesting cover-up and conflicts of interest is extensive. The MHRA have already been given adequate opportunity to reply, but have failed to do so in anything other than a laughable manner. I have no personal interest in the SSRI issue, but the failures of reply with regard to this are already carefully documented by social policy experts for example
at http://www.socialaudit.org.uk/6040000.htm#New

Instead of perpetuating this infinite loop of gobbledegook and delay it would be better if you simply assessed the evidence and failure of answering and attempted to get answers yourself.
Astonishingly, the department of health seems now to be asserting (correspondence as of last week) that the MHRA does not in fact have any legal remit to investigate scientific fraud or ghostwriting by companies in studies involving pharmaceuticals, or in the use of such science in promotional material.

The whole structure of science in pharmaceutical medicine has failed, and the MHRA is certainly implicated in and has colluded with this failure.

If you would like to meet with me to discuss my own rather interesting involvement with this agency I would be most pleased.

Kindly

Dr Aubrey Blumsohn MBBCh, PhD, MSc, BSc(hons), MRCPath

MHRA INVESTIGATE MHRA

-----Original Message-----
From: FOI_Website_Request@mhra.gsi.gov.uk [mailto:FOI_Website_Request@mhra.gsi.gov.uk]
Sent: 05 June 2006 18:00
To: FOI_request Subject: FOI Website Request
Mon Jun 05 18:00:11 BST 2006

Details of information Required:

From correspondence with your information centre, I have been made aware that Glaxo SmithKline are currently under investigation by the MHRA.

Under the Freedom of Information Act (FOI) I request the following questions to be answered:

1. Will Dr Pete Breggin's 38 page report be used as part of the investigation?

2. Will Sir Alistair Breckenridge and Dr Ian Hudson play any part of the investigation? If so, what role will they play? If not, Why?

3. Have the police been drafted in to help with enquiries? If not, Why?

4. Will the Prof. Kent Woods, CEO of the MHRA accept full responsibility for the failings of the review boards concerning the anti - depressant drug Seroxat? If not, Why?

5. Evidence suggests that at least two members of the MHRA, Sir Alistair Breckenridge and Dr Ian Hudson, were both employed by Glaxo SmithKline during the adult trials for Seroxat. Given that - It is conceiveable that both knew that their employers had suppressed evidence from both the public and the MHRA. Will both Sir Alistair Breckenridge and Dr Ian Hudson be prosecuted?

I trust you can give me answers to these questions in due course. If for some reason you cannot, I request a full, detailed response as to why you cannot give me answers.

Meantime, I look forward to your reply.
Mr. Robert Fiddaman

-----------------------

RESPONSE FROM MHRA

----- Original Message -----
From: Lee-Frost, Danny
To: fiddaman64@blueyonder.co.uk
Sent: Tuesday, June 27, 2006 2:05 PM
Subject: Freedom of Information request

Dear Mr Fiddaman.

REF: FOI 06/189 Thank you for your enquiry of 5th June. I am writing to let you know that we are unable to supply part the information you have requested. Under the Freedom of Information Act (FOIA) certain exemptions apply to the information we can make available.

The information you have requested concerning a criminal investigation is subject to the exemption contained in the FOIA, namely exemption 30. We have concluded that disclosing this information would not be appropriate because it would prejudice an ongoing criminal investigation. I am satisfied that both categories in exemption 30 are applicable;

a) where information has at any time been held for the purpose of specified criminal and other investigations or proceedings; and

b) where information relates to the obtaining of information from confidential sources and was obtained or recorded for a number of specified investigations or proceedings.

Therefore it would not be in the public interest to disclose the outcome of the criminal investigation in advance of any potential court proceedings.

However I can confirm that the investigation to which you refer is being conducted by the Criminal Investigation Unit of the Enforcement & Intelligence Group and the services of the police have not been required. For more information on the work of this group please visit the MHRA website at www.mhra.gov.uk

If you have a query about this letter, please contact me. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 10th Floor, Medicines and Healthcare products Regulatory Agency, at the above address quoting the above reference. After that, if you remain dissatisfied, you may ask the Information Commissioner at

The Information Commissioner's Office Wycliffe House Water Lane Wilmslow Cheshire SKI OAF to make a decision on whether or not we have interpreted the FOI correctly in withholding information from you.

Yours sincerely

Danny Lee-Frost Head of Enforcement Medicines & Healthcare products Regulatory Agency

Room 18-108
Tel: 020 7084 2618/2173
Mob: 07712 556 352
danny.lee-frost@mhra.gsi.gov.uk

SEROXAT LINKS

Here are some links to pages where you can see for yourself how Glaxo SmithKline and/or The MHRA have been duping the public.

http://health.groups.yahoo.com/group/seroxat/

http://www.socialaudit.org.uk/

http://www.ahrp.org/

http://www.paulflynnmp.co.uk/newsdetail.jsp?id=423

http://www.thejabberwock.org/mhra.htm

http://anti-depression.net/articles/Paxil.html

http://news.yahoo.com/s/huffpost/20060521/cm_huffpost/021388

http://paxilprotest.com/

http://www.redorbit.com/modules/news/tools.php?tool=print&id=131376

http://www.real-medicine.org/bull.htm

http://www.benzo.org.uk/press.htm

http://www.newmediaexplorer.org/sepp/2004/10/07/pharma_tame_watchdogs_not_protecting_public_health.htm

http://www.guardian.co.uk/uk_news/story/0,3604,415720,00.html

http://66.249.93.104/search?q=cache:sB2Xo91yJmMJ:www.emea.eu.int/pdfs/general/contacts/ihudson_DI.pdf+dr+ian+hudson+financial+interests&hl=en&gl=uk&ct=clnk&cd=1




UK VISITORS VOICE YOUR CONCERNS TO THE HEALTH SELECT COMMITTEE HERE:

http://www.parliament.uk/parliamentary_committees/health_committee/health_committee_members.cfm

EMAIL YOUR MP HERE:

http://www.writetothem.com/

EMAIL THE MHRA HERE:

http://www.mhra.gov.uk/ or directly to info@mhra.gsi.gov.uk

EMAIL THE CHIEF EXECUTIVE OF THE MHRA HERE:

kent.woods@mhra.gsi.gov.uk

THE TRUTH IS OUT THERE

THE TRUTH IS OUT THERE... WE WILL EXPOSE YOU

Seroxat Support Group

A WORK OF FICTION... OR IS IT?

Hello, my name is Sir Andrew Brokenbridge. I was knighted back in 97 for my work in the field of Medicines. Currently I serve the British public by being part of a team that regulate medicines - after all, we don't want you taking medicines that are bad for you do we?

In 1992, I was World Safety Officer for a Pharmaceutical Company where my job was to oversee that all medicines met our stringent criteria. Obviously, there was some medicines that never quite came up to scratch with our criteria but with a little tweaking here and there such as hiding clinical trial evidence or just not being forthright with the regulator we were able to run a smooth ship. After all, it was only a few people that would suffer opposed to the millions it would help. The public would never find out and no lawyer in his or her right mind would ever dare to take on a Pharmaceutical Company with an endless pot of money. Even if it did leak out that we suppressed clinical trial evidence we could always put up a smokescreen. We have a clever legal department you see and our own language when it comes to Patient Information Leaflets (The information you read that comes with your medicine) We stick to no dictionary - we have our own versions of the English language. The word 'Addiction' does not exist in our dictionary.

Through regular Freemason meetings, I was asked to join the Medicines regulator, where my job would be to regulate the medicines my employer was manufacturing. To my delight, I found that the Medicines regulator also had their very own dictionary and were made up of ex-Pharmaceutical Company employees. Therefore, with a nice golden handshake I left my employer, Smith DontKare (SDK) to take up my new post.

Sometime down the line I had the shock of my life when one of the drugs I monitored whilst employed at SDK came up for review by the Medicines regulator. My whole world came tumbling down but I was soon put at ease when I heard the suppressed evidence would not be submitted. Phew! I thought I was for the high jump then I can tell you. The second time this particular drug was reviewed I felt more at ease as basically the same evidence was submitted. No one would ever find out how my former employers were able to suppress evidence. Life just could not get any better.

I'd heard rumblings of support groups popping up over the internet regarding this particular drug and heard on the grapevine that BBC TV were running a special programme on their pioneer show 'Panorama'. I must admit I did have a giggle to myself about this although my colleague, Dr Liam Disdain, had fears. He too now worked alongside me and was also a former employee of SDK. He too knew about the suppressed evidence. Anyway, I reassured him that we were in the clear, as SDK would never allow their trial data to be looked at - even if they were subpoenaed, they would do everything in their power to make it difficult for the researcher looking for the particular trial data. I told Dr Disdain that they would probably stick some Professor in a room full of records and the possibilities of him/her ever finding what he/she was searching for was a zillion to one! We both laughed at that image.

The BBC ran the programme but little came of it. It certainly never bothered us in the Medicines regulator department. It did however build up a strong membership base in those pesky online support groups - even more so when a second programme was aired by the BBC. Again though, we here at the Medicines regulator department did not take much notice. The drug helped millions of people and even though lawsuits were happening in the States my former employers, SDK, could further suppress the hidden evidence by making substantial out of court settlements. When settled out of court both parties would agree to keep all the evidence sealed. Anyway, that was America - no one from the UK would ever dare take on a Pharmaceutical Company - for one they would not get public funding. Both Dr Disdain and I were quietly comfortable. In fact, we had both been given the nicknames 'The Untouchables' back at the Freemasons lodge.

A third programme was to be aired by the BBC and I was asked to do an interview with the investigative reporter. I took legal advice and was told what to say by my legal team - which amounted to sidestepping any questions the interviewer put to me. I really put her in her place by answering almost every question with, 'That is a matter that is currently being investigated'. Had the camera's been panned on her you would have been able to see the frustration in her face. I felt like Al Capone - I was untouchable.

This third programme however created a lot of public reaction and soon after a firm of Solicitors in Wales decided they would take on the might of SDK. They do not stand a chance, I told Dr Disdain. For one they will not get public funding! Dr Disdain told me that certain members of one of the pesky support groups were asking many questions about him and I. Luckily for us, the Chief Executive of the Medicine Regulatory Board was 100% behind us. Although Prof. Clark Kent was our boss he was also a good friend. We called him 'Superman' back at the Freemasons lodge for obvious reasons!

Clark told us both that support group members were asking for both mine and Dr Disdain's resignation from our posts here at the Medicines regulatory department. Whom did they think they were dealing with? I have more letters after my surname than they do in their Christian and middle names! Anyway, we were briefed not to give interviews to the press concerning this drug and any emails or letters we received we could pass off as Spam. To this day, I have not answered any emails sent to me by a member of the public. God, I feel so powerful.

The odd article would appear in the press over the coming months but it was nothing to lose sleep over. Today's news is tomorrow's fish & chip paper. SDK did finally admit that the particular drug was dangerous to children but to be honest they had already made millions of pounds from it so a loss of a few million would be of no significance seeing as their was an increase in depression in the adult population in the UK - they could now target GP's with free holidays and payments and let them know just how good this drug was. Unfortunately, the age where this drug caused problems had moved from under 18's to under 24's but using their dictionary they were able to claim that 18 to 24 did not include the adult population. The data they suppressed back then was for the adult population.

Those pests at the support group were relentless and were unearthing documents over the internet. Damn the internet. They were also lobbying MP's but fortunately, not many were interested as they had local issues to deal with.

On Saturday 13th May 2006, my butler woke me with breakfast and the day's newspapers. I was shocked to read that SDK had yet again moved the goal posts again on the age issue. They had now sent directives to GP's warning them that the drug could cause suicide in patients up to the age of 30. To be honest, I do not know how they get away with it - they have known for years that it is dangerous - as have I.

Oh well, Monday morning now and I am at my desk. I see those pesky group moderators from the support group have been emailing me over the weekend.... One click of the mouse... there you go... into my Spam folder. You cannot get me... I am untouchable.

Sir Andrew Brokenbridge

SEROXAT VIDEOS

Each link will open either Windows media player or Real player


http://www.justiceseekers.com/html/WMV441kHzFinalWeb.wmv

http://g6publish.videodome.com/excite/portal/index.asp?channel=Mental+Health&clipid=54812&bitrate=300&format=wmp

http://www.gsk.com/media/paroxetine/benbow_sideeffect.wmv
(Benbow lying?)

http://www.gsk.com/media/paroxetine/benbow_discontinuation.wmv
(Benbow lying again?)

http://news.bbc.co.uk/olmedia/cta/progs/03/forums/panorama/seroxat11may.ram
(Panorama Interactive)

http://newswww.bbc.net.uk/olmedia/cta/progs/02/forum/panorama/seroxat14oct.ram
(Panorama Interactive Part 2)

http://newsimg.bbc.co.uk/olmedia/cta/progs/03/forums/panorama/seroxat11jul.ram
(Another exclusive and more lies?)

Bob Fiddaman