An open letter to Dr Tsintis Panos of the European Agency for the Evaluation of Medicinal Products (EMEA)
Dear Dr Panos,
Due to recent events surrounding the secrecy of Glaxo SmithKline in suppressing results in the adult Seroxat trials I believe that whatever information you throw at me can be deemed as useless.
For years now the MHRA/EMEA have deemed Seroxat safe in adults. I think both you and I know that is not the case. I asked in the original email (from February 2006) why you don't examine the raw data? You still have not given me a valid excuse for refusing to do this. Why?
Your collegue at the MHRA, Prof. Kent Woods, also refuses to acknowledge Dr Breggin's report - http://www.breggin.com/courtfiling.pbreggin.2006.html which clearly shows how Glaxo SmithKline duped the MHRA, the EMEA and more importantly Doctors and patients around the world.
I have asked whether or not the Report of the Committee on Safety of Medicines Expert Working Group on the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants is now a valid document considering Dr Breggin's report. This has never been answered by any department at the MHRA or EMEA.
This whole issue is a complete and utter shambles and once again points the finger at how the EMEA/MHRA is run and whether or not there is a clear sign of a conflict of interests within your departments.
You must have been briefed on Dr Breggin's findings and I would assume that you, along with others at the EMEA/MHRA, have been told not to say anything.
The silence from the MHRA/EMEA over Dr Breggin's report is deafening and one can only assume that you are hiding the truth from the general public - the same general public you have promised to protect.
You may feel that the EMEA/MHRA are untouchable - it's one thing to play God, another to be God.
The media war is hotting up and already there are interested parties waiting to write an in-depth story into the close associations with Glaxo SmithKline and the EMEA/MHRA.
I have copied this email to who I assume is your boss, Prof. Kent Woods. I shall also be forwarding copies to people of relevance.
The MHRA/EMEA have been given enough chances to make a public comment about these recent findings - meantime, Seroxat is still prescribed to patients despite you and your peers having knowledge that it is a defective drug. How do you define the Civil Service Code you are supposed to adhere to?
I anticipate this email will be passed around to your legal team before you are allowed to answer. Maybe I will get a reply wihin the next six months... then again I may be best putting all my hope into waiting for a pig to come flying past my window.
Yours sincerely
Robert Fiddaman
Dip.Couns MOC & MSFTR
"It's not about what they tell you, it's about what they don't."
~ Bob Fiddaman, Author, Blogger, Researcher, Recipient of two Human Rights awards
Zantac Lawsuit
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Wednesday, April 26, 2006
Tuesday, April 11, 2006
CHIEF EXECUTIVE STANDS BY COMMENTS
Date 16 December 2005
Ref:
Subject Seroxat
Dear Mr Fiddaman,
Thank you for the email that you sent colleagues in the wider Department of Health expressing your concerns about conflicts of interests of staff of the Medicines and Healthcare products Regulatory Agency (MHRA). I was extremely sorry to learn of the problems you have experienced since being diagnosed with clinical depression. I felt that it is important that I respond to you personally on this matter so that you fully appreciate how committed I am to ensuring that the MHRA��s decisions are both transparent and impartial.
The medicines regulatory work of the MHRA is funded by statutory fees which it charges to industry. The Governance of the Agency ensures objectivity and impartiality of all decision making. Like all government officials, members of the MHRA are subject to the Civil Service Code. The Code requires all civil servants to conduct themselves with integrity, impartiality and honesty. The code also requires all staff to declare to their department or agency any business interests (including directorships) or holdings of shares or other securities which they or members of their immediate family (spouse, including partner where relevant, and children) hold, to the extent which they are aware of them, which they would be able to further as a result of their official position.
From November 2005, European regulations will require that MHRA staff do not hold financial or other interests that could affect their impartiality. In line with this, the agency has created a comprehensive register of all current interests of all staff and has required staff to dispose of all such interest by July 2005. Please note that these regulations do not apply to pensions accruing from previous employment in industry or to pooled investments where individuals cannot influence investment strategy, such as unit trusts.
I am sure you will agree that given the nature of the work of the Agency it is desirable that staff have an understanding of the work of the pharmaceutical industry and indeed for some Agency roles (particularly those relating to good manufacturing and good clinical practice) industrial experience is necessary. Further, the Government actively encourages interchange between the Civil Service and industry but takes care to ensure that there are seen to be no conflicts of interest. In line with this principle, since joining the Agency Dr Hudson (Director of Licensing) has had no involvement in matters relating to Seroxat GSK products and no involvement in the European referral.
Recently the MHRA has taken important steps towards ensuring greater transparency of its activities, including:
? Disclosure of the evidence underpinning its decisions in areas of public concerns such as the safety of selective serotonin reuptake inhibitors and hormone replacement therapy;
? From January 2004, we have published on our website summary data on suspected adverse drug reactions (ADRs) that have been received through the Yellow Card Scheme in association with medicines;
? From November 2005, we will be producing UK public assessment reports for each medicine that we license. These will provide details of the clinical trials submitted in support of the licence application.
I will also take this opportunity to address your requests under the freedom of information act for information relating to Dr Ian Hudson's Declaration of Interests and for data relevant to the European Medicines�� Agency��s (EMEA) recommendation that Seroxat (paroxetine) should be prescribed with extra caution to those aged between 18 and 29.
The declaration of the interests of all members of the European Committee for Human Medicinal Products (CHMP), including Dr Hudson��s, are available on the EMEA website (www.emea.eu.int/htms/general/contacts/CHMP.html).
The recommendations relating to paroxetine of the EMEA's scientific advisory committee the Committee for Proprietary Medicinal Products, CPMP (now CHMP) are summarised below and are available on the EMEA website (www.emea.eu.int).
The Europe-wide review of the risks and benefits of Seroxat undertaken by the then CPMP concluded that no strong evidence had been found to support an increased risk of suicidal behaviour in young adults aged 18-29 years. The CPMP, however, recommended that patients at high baseline risk of suicidal behaviour should be closely monitored during treatment with paroxetine. These include patients with a known history of suicidal behaviour or thoughts prior to starting treatment, and young adults as a patient group. In April 2004, a summary of the opinion of the CPMP referring to the need for monitoring young adults during paroxetine treatment was released on the EMEA and MHRA websites. This message was reiterated in the October 2004 edition of the drug safety bulletin Current Problems in Pharmacovigilance which is sent to all doctors and pharmacists in the UK.
The clinical trial data relating to the risk of suicidal events in patients between the ages of 18 and 29 treated with paroxetine can be found on pages 77 and 78 of the final report of the Committee on Safety of Medicines�� Expert Working Group on the Safety of SSRIs. This report is available on the MHRA website (www.mhra.gov.uk).
In relation to the use of SSRIs in young adults the Expert Working Group concluded that there is no clear evidence of an increased risk of self-harm and suicidal thoughts in young adults of 18 years or over. However, given that individuals mature at different rates and that young adults are at a higher background risk of suicidal behaviour than older adults, as a precautionary measure young adults treated with SSRIs should be closely monitored. The Group also recommended that in further research on the safety and efficacy of SSRIs, young adults should be assessed separately.
Yours sincerely,
Send via e-mail
Professor Kent Woods
Chief Executive
My reply (sent 7 times to Prof. Kent Woods) after new evidence was uncovered that suggests that Glaxo SmithKline suppressed clinical data from the MHRA during the adult trials for Seroxat:
Dear Prof.Woods.You may recall sometime ago I wrote you about my concerns over the running of the MHRA and the anti-depressant drug, Seroxat. I was grateful for your lengthy response to me Ref: FOI 05/351 DE00040671.
As you are probably aware a recent previously sealed court document was opened in the United States which is damning for Glaxo SmithKline.(See Attached) It clearly shows that they witheld vital information during the clinical trials for Seroxat.
In your previous lengthy response to me you gave me assurances that the MHRA's responses were both transparent and impartial. You also added that members of the MHRA are subject to the Civil Service Code and that code required all members to conduct themselves with integrity, impartiality and honesty.
You added further that the Europe-wide review of the risks and benefits of Seroxat undertaken by the then CPMP concluded that no strong evidence had been found to support an increased risk of suicidal behaviour. You also went on to say that the Expert Working Group concluded that there was no clear evidence of an increased risk in self-harm and suicidal thoughts in young adults of 18 years or over.
With the evidence attached to this email I would like to know if you still stand by your original letter to me.
I would also like to point out to you that I am well aware that Dr Ian Hudson and Sir Alistair Breckenridge have never sat on a review board regarding Seroxat. My question to you Prof. Woods is plain and simple and one that will cast doubt upon the MHRA's 'Civil Service Code'
Dr Ian Hudson and Sir Alistair Breckenridge were both employed by Glaxo SmithKline - both must have known about the suppressed data (attached) yet both decided not to mention it to other members of the MHRA. My question is, Why?
Meantime, Seroxat continues to be prescribed to both adults and children when clearly it is a drug that was shown in the trials that could cause suicide/suicidal thoughts and/or aggression.
I put it to you that both Dr Ian Hudson and Sir Alistair Breckenridge have not acted with integrity, impartiality or honesty in fact quite the contrary.
You now have clear evidence of this yet you, the Chief Executive of the MHRA, still refuse to acknowledge that this drug is defective and that the board of the MHRA have all acted subject to the 'Civil Service Code'
I trust that you, as the Chief Executive, will take action once your investigations are complete and I urge you to send out directives to GP's to stop prescribing this defective drug to new patients. It must be done with immediate effect before there is more blood on GSK's/MHRA's hands.
Meantime, I look forward to your reply
Yours sincerely
Robert Fiddaman
(Group Moderator of the Online Seroxat Support Group)
Ref:
Subject Seroxat
Dear Mr Fiddaman,
Thank you for the email that you sent colleagues in the wider Department of Health expressing your concerns about conflicts of interests of staff of the Medicines and Healthcare products Regulatory Agency (MHRA). I was extremely sorry to learn of the problems you have experienced since being diagnosed with clinical depression. I felt that it is important that I respond to you personally on this matter so that you fully appreciate how committed I am to ensuring that the MHRA��s decisions are both transparent and impartial.
The medicines regulatory work of the MHRA is funded by statutory fees which it charges to industry. The Governance of the Agency ensures objectivity and impartiality of all decision making. Like all government officials, members of the MHRA are subject to the Civil Service Code. The Code requires all civil servants to conduct themselves with integrity, impartiality and honesty. The code also requires all staff to declare to their department or agency any business interests (including directorships) or holdings of shares or other securities which they or members of their immediate family (spouse, including partner where relevant, and children) hold, to the extent which they are aware of them, which they would be able to further as a result of their official position.
From November 2005, European regulations will require that MHRA staff do not hold financial or other interests that could affect their impartiality. In line with this, the agency has created a comprehensive register of all current interests of all staff and has required staff to dispose of all such interest by July 2005. Please note that these regulations do not apply to pensions accruing from previous employment in industry or to pooled investments where individuals cannot influence investment strategy, such as unit trusts.
I am sure you will agree that given the nature of the work of the Agency it is desirable that staff have an understanding of the work of the pharmaceutical industry and indeed for some Agency roles (particularly those relating to good manufacturing and good clinical practice) industrial experience is necessary. Further, the Government actively encourages interchange between the Civil Service and industry but takes care to ensure that there are seen to be no conflicts of interest. In line with this principle, since joining the Agency Dr Hudson (Director of Licensing) has had no involvement in matters relating to Seroxat GSK products and no involvement in the European referral.
Recently the MHRA has taken important steps towards ensuring greater transparency of its activities, including:
? Disclosure of the evidence underpinning its decisions in areas of public concerns such as the safety of selective serotonin reuptake inhibitors and hormone replacement therapy;
? From January 2004, we have published on our website summary data on suspected adverse drug reactions (ADRs) that have been received through the Yellow Card Scheme in association with medicines;
? From November 2005, we will be producing UK public assessment reports for each medicine that we license. These will provide details of the clinical trials submitted in support of the licence application.
I will also take this opportunity to address your requests under the freedom of information act for information relating to Dr Ian Hudson's Declaration of Interests and for data relevant to the European Medicines�� Agency��s (EMEA) recommendation that Seroxat (paroxetine) should be prescribed with extra caution to those aged between 18 and 29.
The declaration of the interests of all members of the European Committee for Human Medicinal Products (CHMP), including Dr Hudson��s, are available on the EMEA website (www.emea.eu.int/htms/general/contacts/CHMP.html).
The recommendations relating to paroxetine of the EMEA's scientific advisory committee the Committee for Proprietary Medicinal Products, CPMP (now CHMP) are summarised below and are available on the EMEA website (www.emea.eu.int).
The Europe-wide review of the risks and benefits of Seroxat undertaken by the then CPMP concluded that no strong evidence had been found to support an increased risk of suicidal behaviour in young adults aged 18-29 years. The CPMP, however, recommended that patients at high baseline risk of suicidal behaviour should be closely monitored during treatment with paroxetine. These include patients with a known history of suicidal behaviour or thoughts prior to starting treatment, and young adults as a patient group. In April 2004, a summary of the opinion of the CPMP referring to the need for monitoring young adults during paroxetine treatment was released on the EMEA and MHRA websites. This message was reiterated in the October 2004 edition of the drug safety bulletin Current Problems in Pharmacovigilance which is sent to all doctors and pharmacists in the UK.
The clinical trial data relating to the risk of suicidal events in patients between the ages of 18 and 29 treated with paroxetine can be found on pages 77 and 78 of the final report of the Committee on Safety of Medicines�� Expert Working Group on the Safety of SSRIs. This report is available on the MHRA website (www.mhra.gov.uk).
In relation to the use of SSRIs in young adults the Expert Working Group concluded that there is no clear evidence of an increased risk of self-harm and suicidal thoughts in young adults of 18 years or over. However, given that individuals mature at different rates and that young adults are at a higher background risk of suicidal behaviour than older adults, as a precautionary measure young adults treated with SSRIs should be closely monitored. The Group also recommended that in further research on the safety and efficacy of SSRIs, young adults should be assessed separately.
Yours sincerely,
Send via e-mail
Professor Kent Woods
Chief Executive
My reply (sent 7 times to Prof. Kent Woods) after new evidence was uncovered that suggests that Glaxo SmithKline suppressed clinical data from the MHRA during the adult trials for Seroxat:
Dear Prof.Woods.You may recall sometime ago I wrote you about my concerns over the running of the MHRA and the anti-depressant drug, Seroxat. I was grateful for your lengthy response to me Ref: FOI 05/351 DE00040671.
As you are probably aware a recent previously sealed court document was opened in the United States which is damning for Glaxo SmithKline.(See Attached) It clearly shows that they witheld vital information during the clinical trials for Seroxat.
In your previous lengthy response to me you gave me assurances that the MHRA's responses were both transparent and impartial. You also added that members of the MHRA are subject to the Civil Service Code and that code required all members to conduct themselves with integrity, impartiality and honesty.
You added further that the Europe-wide review of the risks and benefits of Seroxat undertaken by the then CPMP concluded that no strong evidence had been found to support an increased risk of suicidal behaviour. You also went on to say that the Expert Working Group concluded that there was no clear evidence of an increased risk in self-harm and suicidal thoughts in young adults of 18 years or over.
With the evidence attached to this email I would like to know if you still stand by your original letter to me.
I would also like to point out to you that I am well aware that Dr Ian Hudson and Sir Alistair Breckenridge have never sat on a review board regarding Seroxat. My question to you Prof. Woods is plain and simple and one that will cast doubt upon the MHRA's 'Civil Service Code'
Dr Ian Hudson and Sir Alistair Breckenridge were both employed by Glaxo SmithKline - both must have known about the suppressed data (attached) yet both decided not to mention it to other members of the MHRA. My question is, Why?
Meantime, Seroxat continues to be prescribed to both adults and children when clearly it is a drug that was shown in the trials that could cause suicide/suicidal thoughts and/or aggression.
I put it to you that both Dr Ian Hudson and Sir Alistair Breckenridge have not acted with integrity, impartiality or honesty in fact quite the contrary.
You now have clear evidence of this yet you, the Chief Executive of the MHRA, still refuse to acknowledge that this drug is defective and that the board of the MHRA have all acted subject to the 'Civil Service Code'
I trust that you, as the Chief Executive, will take action once your investigations are complete and I urge you to send out directives to GP's to stop prescribing this defective drug to new patients. It must be done with immediate effect before there is more blood on GSK's/MHRA's hands.
Meantime, I look forward to your reply
Yours sincerely
Robert Fiddaman
(Group Moderator of the Online Seroxat Support Group)
Prof. Kent Woods reply - 11th April 2006
----- Original Message -----
From: Woods, Kent
To: fiddaman64
Sent: Monday, April 10, 2006 9:01 AM
Subject: RE: FOI 05/351 DE00040671. **7th request**
Dear Mr Fiddaman
I have already given you a full account of the Agency's position in this matter and there is nothing to add to it.
During this week-end 13 e-mails arrived in my mailbox from yourself and Mr Scott. You cannot be surprised if I and other recipients do not answer them.
Yours sincerely
Kent Woods
And finally - my reply to Prof. Kent Woods response, to which he has not yet answered.
The account you gave me was in December 2005, since then new evidence has come forward that does not support your account - I take it from this email to me you are still standing by your original comments and that I can now quote you when writing to the news media.
Had you the decency to reply to my first email then I would not have sent the others.
The reason why other recipients are not answering is probably because either yourself or powers above you have 'gagged' them because both you and I know that Seroxat is a defective drug and the MHRA have not acted according to Civil Service Code.
Your stubborness is causing lives whilst you continue to ignore the new evidence that GSK suppressed. What is it with you? Have you something to hide?
And while we are on the subject of the shambles that is the MHRA - I would like you to investigate why a letter that was sent to my home address from the MHRA is freely available on your website?
This includes my name and address and violates my privacy.
The MHRA are under the spotlight Mr Woods. Alistair Breckenridge and Ian Hudson knew about the suppressed data and yet you still stand by them.
What chance have we, the British public, got when a Chief Executive cannot see past his errors and admit that the MHRA got it wrong when granting a license to Seroxat?
Your email, along with others will be passed on to whom I see fit and I will not stop until yourself, Alistair Breckenridge and Ian Hudson are thoroughly investigated by an impartial board of experts.
Meantime, I and others shall pursue in our quest to get Seroxat banned with our campaigning, which incidently is growing by the hour.
Yours sincerely
Robert Fiddaman
So there we have it. Prof. Kent Woods, Chief Executive of the MHRA, is standing by his original comments to me (Dec 2005)
Despite the new evidence that has appeared in a Courtroom in the United States that clearly shows Glaxo SmithKline suppressed evidence in the adult Seroxat trials.
Monday, April 10, 2006
Report of the Committee on Safety of Medicines Expert Working Group on the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants
Dear MHRA/EMEAWe, the Online Seroxat Support Group, would like it confirmed that the Report of the Committee on Safety of Medicines Expert Working Group on the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants is now a manual full of false information? http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=242
We request this confirmation due to the recent evidence that has come to light:http://www.breggin.com/Breggin%20Paxil%20Lacuzong%20Report%20Filed%20with%20Court.pdf
Meantime, we await your response
Mr R. Fiddaman Dip.Couns MOC & MSFTRGroup Moderator of the Online Seroxat Support Group
We request this confirmation due to the recent evidence that has come to light:http://www.breggin.com/Breggin%20Paxil%20Lacuzong%20Report%20Filed%20with%20Court.pdf
Meantime, we await your response
Mr R. Fiddaman Dip.Couns MOC & MSFTRGroup Moderator of the Online Seroxat Support Group
Sunday, April 09, 2006
CALLING FOR AN IMAPARTIAL INVESTIGATION INTO THE MHRA & REC
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org/cms/
"Risks of anaphylaxis applies to all studies at PAREXEL, with drugs at every stage of development, and the staff are well trained in anticipation of this (unlikely) possibility. Anaphylaxis could occur any time you encounter any new drug, cosmetic or even foodstuff in a restaurant (peanuts and shellfish are famous for causing it)."
That statement appears on the TGN1412 Informed Consent document (a copy of the one page "possible side effects" was received by AHRP).
In the "possible side effects" section, the consent document begins by assuring volunteers: "no significant side effects have been seen in animal studies...Expert advice from immunologists has been sought in designing the protocol to minimize risks."
The document goes on to disclose the "very unlikely" possibility of "immunosuppression" "autoimmunity" and "cytokine release" which is described as "(causing hive-like allergic reaction)."
As TGN1412 documents are made public, it is apparent that UK government officials of the Medicines and Healthcare Products Regulatory Agency (MHRA) did not tell the truth when they declared (in their interim report) that the catastrophic recation by all six previously healthy volunteers who suffered a "cytokine storm" (or massive autoimmune reaction) almost the instant they were exposed to this monoclonal antibody was "unpredicted biological action of the drug in humans is the most likely cause of the adverse reactions."
The UK Observer reveals: "It emerged this weekend that the Medicines and Healthcare Products Regulatory Agency (MHRA) which authorised the trial was notified beforehand that there was this risk of cytokine release. TeGenero did tell the agency of a previous incident involving a similar drug which had provoked a serious adverse reaction in human volunteers."
Approval of the experiment violated the principles of the Nuremberg Code that stipulated that an experiment such as TGN1412 could ONLY be performed if the human subjects were investigators themselves:
"No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects." Nuremberg Code, principle #5
Britons are calling for "a fully impartial investigation not only of the MHRA but of the Research Ethics Council for allowing six (previously perfectly healthy) volunteers to enter into a potentially lethal clinical trial."
Indeed, the MHRA handling of the catastrophic experiment validates the conclusion of a major parliament report exactly one year ago in April 2005: House of Commons Health Committee The Influence of the Pharmaceutical Industry Fourth Report of Session 2004?05.
The committee expressed concerns about the MHRA evaluation of clinical trials, identifying the overly cozy relationship between the regulator and the pharmaceutical industry, recommending that the MHRA needs to play a greater role during the early stages of drug development.
"The organisation, process and techniques of the MHRA are focused on bringing drugs to market fast," parliamentarians found.
"The organisation has been too close to the industry, a closeness underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff.
"We recommend that more research be undertaken into the adverse effects of drugs, both during drug development and medicines licensing."
See: http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
An investigation by the MHRA of itself will have no credibility with the public.
Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
"Risks of anaphylaxis applies to all studies at PAREXEL, with drugs at every stage of development, and the staff are well trained in anticipation of this (unlikely) possibility. Anaphylaxis could occur any time you encounter any new drug, cosmetic or even foodstuff in a restaurant (peanuts and shellfish are famous for causing it)."
That statement appears on the TGN1412 Informed Consent document (a copy of the one page "possible side effects" was received by AHRP).
In the "possible side effects" section, the consent document begins by assuring volunteers: "no significant side effects have been seen in animal studies...Expert advice from immunologists has been sought in designing the protocol to minimize risks."
The document goes on to disclose the "very unlikely" possibility of "immunosuppression" "autoimmunity" and "cytokine release" which is described as "(causing hive-like allergic reaction)."
As TGN1412 documents are made public, it is apparent that UK government officials of the Medicines and Healthcare Products Regulatory Agency (MHRA) did not tell the truth when they declared (in their interim report) that the catastrophic recation by all six previously healthy volunteers who suffered a "cytokine storm" (or massive autoimmune reaction) almost the instant they were exposed to this monoclonal antibody was "unpredicted biological action of the drug in humans is the most likely cause of the adverse reactions."
The UK Observer reveals: "It emerged this weekend that the Medicines and Healthcare Products Regulatory Agency (MHRA) which authorised the trial was notified beforehand that there was this risk of cytokine release. TeGenero did tell the agency of a previous incident involving a similar drug which had provoked a serious adverse reaction in human volunteers."
Approval of the experiment violated the principles of the Nuremberg Code that stipulated that an experiment such as TGN1412 could ONLY be performed if the human subjects were investigators themselves:
"No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects." Nuremberg Code, principle #5
Britons are calling for "a fully impartial investigation not only of the MHRA but of the Research Ethics Council for allowing six (previously perfectly healthy) volunteers to enter into a potentially lethal clinical trial."
Indeed, the MHRA handling of the catastrophic experiment validates the conclusion of a major parliament report exactly one year ago in April 2005: House of Commons Health Committee The Influence of the Pharmaceutical Industry Fourth Report of Session 2004?05.
The committee expressed concerns about the MHRA evaluation of clinical trials, identifying the overly cozy relationship between the regulator and the pharmaceutical industry, recommending that the MHRA needs to play a greater role during the early stages of drug development.
"The organisation, process and techniques of the MHRA are focused on bringing drugs to market fast," parliamentarians found.
"The organisation has been too close to the industry, a closeness underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff.
"We recommend that more research be undertaken into the adverse effects of drugs, both during drug development and medicines licensing."
See: http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
An investigation by the MHRA of itself will have no credibility with the public.
Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
MHRA WEBSITE
Amazingly if you google the words 'Fiddaman' and 'MHRA' then scroll down the page to:
[PDF] Mr Charles Medawar
File Format: PDF/Adobe Acrobat - View as HTMLMr Robert Fiddaman. MHRA Reference: FOI 06/011. 23 February 2006. Dear Mr Fiddaman ...www.mhra.gov.uk/home/groups/ es-foi/documents/foidisclosure/con2023334.pdf - Similar pages
(ADDRESS HAS BEEN REMOVED DUE TO IT REAPPEARING ON THE INTERNET ELSEWHERE) - Lets hope the person who republished it has the decency to take it down!
Quite why Charles Medawar's name appears is a mystery - an even bigger mystery is that this is a file available for download on the MHRA website.
The file in question is a letter they sent to my home address with answers to questions I put to them earlier this year.
They will have you believe that my name and address have been deleted from the file but if you download the file here: http://www.mhra.gov.uk/home/groups/es-foi/documents/foidisclosure/con2023334.pdf then simply open it and cut and paste the contents into microsoft word - HEY PRESTO! My name and address appears on top of the letter.
This was apparently a confidential letter sent from the MHRA, who remember, strictly adhere the the 'Civil Service Code' and act with integrity, impartiality and honesty.
Not only are they violating my rights, the answers to all three questions (below) do not fit in with Dr Breggin's recent findings, see here: http://www.breggin.com/Breggin%20Paxil%20Lacuzong%20Report%20Filed%20with%20Court.pdf
I have removed my address - but if you do as instructed (above) you will see how the MHRA have made yet another balls up in their filing system.
This ladies & gentlemen are the body of people who regulate the drugs we take!!
Mr Robert Fiddaman
MHRA Reference: FOI 06/011
23 February 2006
Dear Mr Fiddaman
I am writing to you further to your recent correspondence with your MP Gisela Stuart. Ms Stuart has in turn written to Jacqueline Kennedy who has asked that the Medicines and Healthcare products Regulatory Agency respond to your questions under the Freedom of Information (FOI) Act.
Please find below our responses to the questions that you asked relating to paroxetine (Seroxat):
1. How many suicides/suicidal acts coded under the heading of placebo occurred within a 30 day period rather than simply post treatment and how many occurred after 30 days?
In the adult-placebo-controlled trials for paroxetine there were a total of four completed suicides: one in the paroxetine group (on therapy) and three in the placebo group (all in the post-treatment period)
In the first case the patient had made a suicide attempt during the study and a further attempt 14 days after last dose of medication. They committed suicide 33 days after the last dose of study medication.
In the second case the patient committed suicide 17 days after their study medication was stopped. They had received ECT therapy 3 days earlier.
In the third case the patient committed suicide 19 days after their study medication was stopped.
2. How many did involve subjects put on another antidepressant and how many did not involve subjects put on nother antidepressants?
From the case narratives reviewed it does not appear that any of the individuals in these three placebo suicides were receiving an antidepressant drug around the time they died. In one of the cases the individual had received a course of Electroconvulsive therapy (ECT) 3 days prior to the date that they committed suicide.
3. How many cases did the company not now because they had lost contact with the patient?
There is a requirement for all clinical trials to be conducted in accordance with the internationally recognised principles of good clinical practice (GCP), which helps ensure that all trials are conducted to the appropriate high standard and that risks to patients and healthy volunteers are minimised. It is recognised that in any trial a certain percentage of patients will be lost to follow-up, i.e. fail to return for a scheduled follow up visit and never return for further evaluation. Often despite repeated attempts by the investigators to contact them it is not possible to obtain information on what happens to these patients. Therefore, it is not possible for us to provide information on the number of these patients lost to follow-up who may have committed suicides or made suicide attempts.
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 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
SK9 5AF
to make a decision on whether or not we have interpreted the FOIA correctly.
Yours sincerely
Dr Julie Williams
Therapeutic Team Leader
Pharmacovigilance Risk Assessment Unit
Post Licensing Division
Cc Ms Sarah Wark MHRA/PL
[PDF] Mr Charles Medawar
File Format: PDF/Adobe Acrobat - View as HTMLMr Robert Fiddaman. MHRA Reference: FOI 06/011. 23 February 2006. Dear Mr Fiddaman ...www.mhra.gov.uk/home/groups/ es-foi/documents/foidisclosure/con2023334.pdf - Similar pages
(ADDRESS HAS BEEN REMOVED DUE TO IT REAPPEARING ON THE INTERNET ELSEWHERE) - Lets hope the person who republished it has the decency to take it down!
Quite why Charles Medawar's name appears is a mystery - an even bigger mystery is that this is a file available for download on the MHRA website.
The file in question is a letter they sent to my home address with answers to questions I put to them earlier this year.
They will have you believe that my name and address have been deleted from the file but if you download the file here: http://www.mhra.gov.uk/home/groups/es-foi/documents/foidisclosure/con2023334.pdf then simply open it and cut and paste the contents into microsoft word - HEY PRESTO! My name and address appears on top of the letter.
This was apparently a confidential letter sent from the MHRA, who remember, strictly adhere the the 'Civil Service Code' and act with integrity, impartiality and honesty.
Not only are they violating my rights, the answers to all three questions (below) do not fit in with Dr Breggin's recent findings, see here: http://www.breggin.com/Breggin%20Paxil%20Lacuzong%20Report%20Filed%20with%20Court.pdf
I have removed my address - but if you do as instructed (above) you will see how the MHRA have made yet another balls up in their filing system.
This ladies & gentlemen are the body of people who regulate the drugs we take!!
Mr Robert Fiddaman
MHRA Reference: FOI 06/011
23 February 2006
Dear Mr Fiddaman
I am writing to you further to your recent correspondence with your MP Gisela Stuart. Ms Stuart has in turn written to Jacqueline Kennedy who has asked that the Medicines and Healthcare products Regulatory Agency respond to your questions under the Freedom of Information (FOI) Act.
Please find below our responses to the questions that you asked relating to paroxetine (Seroxat):
1. How many suicides/suicidal acts coded under the heading of placebo occurred within a 30 day period rather than simply post treatment and how many occurred after 30 days?
In the adult-placebo-controlled trials for paroxetine there were a total of four completed suicides: one in the paroxetine group (on therapy) and three in the placebo group (all in the post-treatment period)
In the first case the patient had made a suicide attempt during the study and a further attempt 14 days after last dose of medication. They committed suicide 33 days after the last dose of study medication.
In the second case the patient committed suicide 17 days after their study medication was stopped. They had received ECT therapy 3 days earlier.
In the third case the patient committed suicide 19 days after their study medication was stopped.
2. How many did involve subjects put on another antidepressant and how many did not involve subjects put on nother antidepressants?
From the case narratives reviewed it does not appear that any of the individuals in these three placebo suicides were receiving an antidepressant drug around the time they died. In one of the cases the individual had received a course of Electroconvulsive therapy (ECT) 3 days prior to the date that they committed suicide.
3. How many cases did the company not now because they had lost contact with the patient?
There is a requirement for all clinical trials to be conducted in accordance with the internationally recognised principles of good clinical practice (GCP), which helps ensure that all trials are conducted to the appropriate high standard and that risks to patients and healthy volunteers are minimised. It is recognised that in any trial a certain percentage of patients will be lost to follow-up, i.e. fail to return for a scheduled follow up visit and never return for further evaluation. Often despite repeated attempts by the investigators to contact them it is not possible to obtain information on what happens to these patients. Therefore, it is not possible for us to provide information on the number of these patients lost to follow-up who may have committed suicides or made suicide attempts.
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 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
SK9 5AF
to make a decision on whether or not we have interpreted the FOIA correctly.
Yours sincerely
Dr Julie Williams
Therapeutic Team Leader
Pharmacovigilance Risk Assessment Unit
Post Licensing Division
Cc Ms Sarah Wark MHRA/PL
EMAIL TO THE OBSERVER (Sun 9th April 2006)
Below is an email I have sent to Jo Revill, Health Editor of The Observer
----- Original Message -----
From: fiddaman64
To: editor@guardianunlimited.co.uk
Sent: Sunday, April 09, 2006 9:23 AM
Subject: FAO: Jo Revill - re: Drug trial firm knew of risk
Dear Jo,
I read with great interest your article 'Drug trial firm knew of risk' and would like to bring to your attention a series of cover-ups from Pharmaceutrical giants, Glaxo SmithKline (GSK) and the Medicines and Healthcare products Regulatory Agency (MHRA).
As you are probably aware a recent previously sealed court document was opened in the United States which is damning for Glaxo SmithKline. It clearly shows that they witheld vital information during the clinical trials for Seroxat.
The report shows how they knowingly suppressed data which basically showed that Seroxat showed a higher rate of suicidal ideation and aggressiveness.
The MHRA are made up of medical experts, two of which are former employees of GSK, namely Dr Ian Hudson and Sir Alistair Breckenridge. In October 2005, Prof. Kent Woods, Chief Executive of the MHRA, wrote me to give me assurances that Seroxat was safe and that there was no conflict of interests within the MHRA. He also assured me that both Dr Ian Hudson and Sir Alistair Breckenridge never sat on the panel when Seroxat was being reviewed by the MHRA.
Both Dr Ian Hudson and Sir Alistair Breckenridge must have known about the suppressed data yet failed to mention this despite reported suicides and aggression in the news media.
I have included the 31 page document for your perusal and you will see from it's content that GSK knowingly witheld vital information from the MHRA.
This is scandalous and goes against all medical ethics.
Emails to Prof. Kent Woods from myself and members of the Online Seroxat Support Group of which I am a moderator, are being ignored.
It needs somebody like yourself to highlight these issues with your reporting - maybe then we will get answers.
Founder member of the Online Seroxat Support Group, Mr Derek Scott, requested from Prof. Kent Woods the Informed Consent Document!! Under the FOI (Freedom of Information Act 2000). Mr Woods rather flippant response was:
Dear Mr Scott
Approval of the Informed Consent document does not form part of the clinical trial authorisation process performed by the MHRA under the legislation. That is the task of a Research Ethics Committee, to which the research sponsors make a separate application.
Regards
Kent Woods
CEO
We believe this to be a lie and as we speak are in touch with the Research Ethics Committee - maybe you could throw some light on Prof. Kent Woods response?
Meantime, Seroxat is still being prescribed to patients and adverse effects are still being reported - The MHRA are NOT doing their duty.
I sincerely hope you can help us in our plight to get answers from the MHRA Jo.
I shall be adding this email to you to my blog http://fiddaman.blogspot.com/ which is full of information regarding the MHRA/EMEA and GSK.
Meantime, I look forward to your reply.
Mr Robert Fiddaman (Group Moderator for the Online Seroxat Support Group)
----- Original Message -----
From: fiddaman64
To: editor@guardianunlimited.co.uk
Sent: Sunday, April 09, 2006 9:23 AM
Subject: FAO: Jo Revill - re: Drug trial firm knew of risk
Dear Jo,
I read with great interest your article 'Drug trial firm knew of risk' and would like to bring to your attention a series of cover-ups from Pharmaceutrical giants, Glaxo SmithKline (GSK) and the Medicines and Healthcare products Regulatory Agency (MHRA).
As you are probably aware a recent previously sealed court document was opened in the United States which is damning for Glaxo SmithKline. It clearly shows that they witheld vital information during the clinical trials for Seroxat.
The report shows how they knowingly suppressed data which basically showed that Seroxat showed a higher rate of suicidal ideation and aggressiveness.
The MHRA are made up of medical experts, two of which are former employees of GSK, namely Dr Ian Hudson and Sir Alistair Breckenridge. In October 2005, Prof. Kent Woods, Chief Executive of the MHRA, wrote me to give me assurances that Seroxat was safe and that there was no conflict of interests within the MHRA. He also assured me that both Dr Ian Hudson and Sir Alistair Breckenridge never sat on the panel when Seroxat was being reviewed by the MHRA.
Both Dr Ian Hudson and Sir Alistair Breckenridge must have known about the suppressed data yet failed to mention this despite reported suicides and aggression in the news media.
I have included the 31 page document for your perusal and you will see from it's content that GSK knowingly witheld vital information from the MHRA.
This is scandalous and goes against all medical ethics.
Emails to Prof. Kent Woods from myself and members of the Online Seroxat Support Group of which I am a moderator, are being ignored.
It needs somebody like yourself to highlight these issues with your reporting - maybe then we will get answers.
Founder member of the Online Seroxat Support Group, Mr Derek Scott, requested from Prof. Kent Woods the Informed Consent Document!! Under the FOI (Freedom of Information Act 2000). Mr Woods rather flippant response was:
Dear Mr Scott
Approval of the Informed Consent document does not form part of the clinical trial authorisation process performed by the MHRA under the legislation. That is the task of a Research Ethics Committee, to which the research sponsors make a separate application.
Regards
Kent Woods
CEO
We believe this to be a lie and as we speak are in touch with the Research Ethics Committee - maybe you could throw some light on Prof. Kent Woods response?
Meantime, Seroxat is still being prescribed to patients and adverse effects are still being reported - The MHRA are NOT doing their duty.
I sincerely hope you can help us in our plight to get answers from the MHRA Jo.
I shall be adding this email to you to my blog http://fiddaman.blogspot.com/ which is full of information regarding the MHRA/EMEA and GSK.
Meantime, I look forward to your reply.
Mr Robert Fiddaman (Group Moderator for the Online Seroxat Support Group)
Saturday, April 08, 2006
YOU CAN RUN ... BUT YOU CAN'T HIDE PROF. WOODS
Despite sending the following email to Prof. Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) - He has still failed to respond.
You can run... but you can't hide
I demand answers
Dear Prof.Woods.You may recall sometime ago I wrote you about my concerns over the running of the MHRA and the anti-depressant drug, Seroxat. I was grateful for your lengthy response to me Ref: (Witheld)
As you are probably aware a recent previously sealed court document was opened in the United States which is damning for Glaxo SmithKline. It clearly shows that they witheld vital information during the clinical trials for Seroxat.
In your previous lengthy response to me you gave me assurances that the MHRA's responses were both transparent and impartial. You also added that members of the MHRA are subject to the Civil Service Code and that code required all members to conduct themselves with integrity, impartiality and honesty.
You added further that the Europe-wide review of the risks and benefits of Seroxat undertaken by the then CPMP concluded that no strong evidence had been found to support an increased risk of suicidal behaviour. You also went on to say that the Expert Working Group concluded that there was no clear evidence of an increased risk in self-harm and suicidal thoughts in young adults of 18 years or over.
With the evidence attached to this email I would like to know if you still stand by your original letter to me.
I would also like to point out to you that I am well aware that Dr Ian Hudson and Sir Alistair Breckenridge have never sat on a review board regarding Seroxat. My question to you Prof. Woods is plain and simple and one that will cast doubt upon the MHRA's 'Civil Service Code'
Dr Ian Hudson and Sir Alistair Breckenridge were both employed by Glaxo SmithKline - both must have known about the suppressed data (attached) yet both decided not to mention it to other members of the MHRA. My question is, Why?
Meantime, Seroxat continues to be prescribed to both adults and children when clearly it is a drug that was shown in the trials that could cause suicide/suicidal thoughts and/or aggression.
I put it to you that both Dr Ian Hudson and Sir Alistair Breckenridge have not acted with integrity, impartiality or honesty in fact quite the contrary.
You now have clear evidence of this yet you, the Chief Executive of the MHRA, still refuse to acknowledge that this drug is defective and that the board of the MHRA have all acted subject to the 'Civil Service Code'
I trust that you, as the Chief Executive, will take action once your investigations are complete and I urge you to send out directives to GP's to stop prescribing this defective drug to new patients. It must be done with immediate effect before there is more blood on GSK's/MHRA's hands.
Meantime, I look forward to your reply
Yours sincerely
Robert Fiddaman
(Group Moderator of the Online Seroxat Support Group)
You can run... but you can't hide
I demand answers
Dear Prof.Woods.You may recall sometime ago I wrote you about my concerns over the running of the MHRA and the anti-depressant drug, Seroxat. I was grateful for your lengthy response to me Ref: (Witheld)
As you are probably aware a recent previously sealed court document was opened in the United States which is damning for Glaxo SmithKline. It clearly shows that they witheld vital information during the clinical trials for Seroxat.
In your previous lengthy response to me you gave me assurances that the MHRA's responses were both transparent and impartial. You also added that members of the MHRA are subject to the Civil Service Code and that code required all members to conduct themselves with integrity, impartiality and honesty.
You added further that the Europe-wide review of the risks and benefits of Seroxat undertaken by the then CPMP concluded that no strong evidence had been found to support an increased risk of suicidal behaviour. You also went on to say that the Expert Working Group concluded that there was no clear evidence of an increased risk in self-harm and suicidal thoughts in young adults of 18 years or over.
With the evidence attached to this email I would like to know if you still stand by your original letter to me.
I would also like to point out to you that I am well aware that Dr Ian Hudson and Sir Alistair Breckenridge have never sat on a review board regarding Seroxat. My question to you Prof. Woods is plain and simple and one that will cast doubt upon the MHRA's 'Civil Service Code'
Dr Ian Hudson and Sir Alistair Breckenridge were both employed by Glaxo SmithKline - both must have known about the suppressed data (attached) yet both decided not to mention it to other members of the MHRA. My question is, Why?
Meantime, Seroxat continues to be prescribed to both adults and children when clearly it is a drug that was shown in the trials that could cause suicide/suicidal thoughts and/or aggression.
I put it to you that both Dr Ian Hudson and Sir Alistair Breckenridge have not acted with integrity, impartiality or honesty in fact quite the contrary.
You now have clear evidence of this yet you, the Chief Executive of the MHRA, still refuse to acknowledge that this drug is defective and that the board of the MHRA have all acted subject to the 'Civil Service Code'
I trust that you, as the Chief Executive, will take action once your investigations are complete and I urge you to send out directives to GP's to stop prescribing this defective drug to new patients. It must be done with immediate effect before there is more blood on GSK's/MHRA's hands.
Meantime, I look forward to your reply
Yours sincerely
Robert Fiddaman
(Group Moderator of the Online Seroxat Support Group)
CLINICAL TRIAL AUTHORISATION
Founder member of the Online Seroxat Support Group (OSSG) Mr Derek Scott, has requested for the Informed Consent Document to be released under the Freedom of Information Act 2000.
To his suprise he recieved a personal reply from Prof. Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) which is below for you to peruse.
Dear Mr Scott
Approval of the Informed Consent document does not form part of the clinical trial authorisation process performed by the MHRA under the legislation. That is the task of a Research Ethics Committee, to which the research sponsors make a separate application.
Regards
Kent Woods
CEO
Mr Derek Scott is now liasing with the Research Ethics Committee to see if what Prof. Kent Woods is indeed true.
My own MP, Gisela Stuart, is now trying to contact The Health Select Committee on my behalf. I have previously sent out emails to every single member of The Health Select Committee - not one of them has had the decency to even acknowledge receipt of my emails.
More about the Research Ethics Committee soon.
Bob Fiddaman (Group Moderator of the Online Seroxat Support Group)
To his suprise he recieved a personal reply from Prof. Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) which is below for you to peruse.
Dear Mr Scott
Approval of the Informed Consent document does not form part of the clinical trial authorisation process performed by the MHRA under the legislation. That is the task of a Research Ethics Committee, to which the research sponsors make a separate application.
Regards
Kent Woods
CEO
Mr Derek Scott is now liasing with the Research Ethics Committee to see if what Prof. Kent Woods is indeed true.
My own MP, Gisela Stuart, is now trying to contact The Health Select Committee on my behalf. I have previously sent out emails to every single member of The Health Select Committee - not one of them has had the decency to even acknowledge receipt of my emails.
More about the Research Ethics Committee soon.
Bob Fiddaman (Group Moderator of the Online Seroxat Support Group)
Friday, April 07, 2006
WHY RICHARD BROOK RESIGNED
Why I resigned over 'happy pill' cover-up by RICHARD BROOK, Daily Mail 09:36am 23rd March 2004
Last week I resigned from the Government's watchdog on anti-depressants after it tried to cover up its own ten-year failure to identify serious side-effects of the controversial drug Seroxat.
The Medicines and Healthcare Products Regulation Agency found from information that had been in its possession for more than a decade that high doses of the anti-depressant can lead to aggression and thoughts of suicide.
But instead of revealing the truth to the 17,000 people taking high doses and the other half-million Britons on a safer dose, the MHRA sat on its findings.
Astonishingly, I was actually threatened with legal action by Professor Kent Woods, chief executive of the MHRA, if I revealed this.
Mind, the mental health charity, has been tracking Seroxat for a decade and found it to be the most problematic anti-depressant. Side-effects include nervousness, aggression, irrational thoughts and, in some cases, feelings of suicide.
Although Seroxat has been effective for thousands suffering from severe depression, there are many who blame tragic events, including murders and suicide, on it. Last year, BBC's Panorama showed that - despite denials from the manufacturer - people can get hooked on Seroxat and suffer terrible withdrawal symptoms when trying to come off it.
Manufacturer played down side-effects
The drug's manufacturer, GlaxoSmithKline, has sought to play down its side-effects, denying until last year that it could be addictive. Mind - along with dozens of people suffering the drug's side-effects - held a demonstration last June outside MHRA's headquarters in London, calling for the drug regulator to take action.
By the end of that week, I had been invited to join its expert panel to look at the effectiveness of the so-called "happy pills", selective serotonin re-uptake inhibitors (SSRIs) - drugs prescribed to tackle depression, anxiety and other psych-ological problems. They include Prozac and Seroxat.
I hoped we could issue clear guidance to doctors on how to prescribe SSRIs safely. But my colleagues at the regulator, all from the medical establishment - doctors, academics and psychiatrists - had different ideas. They appeared more interested in putting their reputations, and those of drugs companies, before the safety of patients.
In October, the MHRA reviewed data from the earliest trials of Seroxat. The information was supplied by GlaxoSmithKline in the late Eighties, and it was the MHRA's responsibility to analyse the statistics to inform its decisions.
In four reviews of these statistics over ten years, the regulator had failed to pick up the vital information that any dose of Seroxat above 20mg a day doesn't work any better but significantly increases the side-effects.
Hundreds prescribed dangerous levels
Some 17,000 people were prescribed more than 20mg of Seroxat last year. But the panel wanted to kick the findings into the long grass, passing it to European regulators. It would take months. In that time, hundreds would be prescribed dangerous levels of Seroxat.
It was then that Professor Woods made clear I faced prosecution if I revealed what the regulator had found, citing the need to protect the "commercial confidentiality" of drugs firms.
On the MHRA website, Professor Woods defends the watchdog, saying its advice is backed by clinical data.
A few days later, I went to see Health Minister Lord Warner to tell him of my concerns. He said he would speak to the regulator, and soon after they reluctantly published the findings.
Their statement "reminded" doctors not to prescribe more than 20mg, as if it had been common practice all along. Previously, the MHRA's recommended "safe" dose was 20mg to 50mg a day.
I resigned. If a regulator will not own up to its mistakes, who knows if data about other drugs has not also been overlooked, with potentially fatal results.
Regulators are supposed to be a stop-check for safety issues. But at the MHRA, many of the people who work there or advise it have ties to drugs firms. Some have shares in the companies, research departments funded by them or receive fees for advice.
The only protection is a musical chairs system where you leave the room if you have an interest in the drug being discussed or its manufacturer, or you can stay but not vote.
Need for independent inquiry
There is an urgent need for an independent inquiry into the MHRA. The Government must also change its culture of secrecy.
Seroxat is far too extensively prescribed, especially for mild and moderate depression. But anti-depressants - including SSRIs - do work, and can prevent suicides in severe cases. However, they are not wonder drugs.
GPs should clearly outline all the options to sufferers and anti-depressants shouldn't be the automatic answer. If vital information such as that the MHRA tried to cover up is not released, these decisions cannot be fully informed.
Likewise, patients on Seroxat concerned by my findings should consult their doctor before adjusting their medication.
Mind does a lot of work with the Government, and we have a good relationship. But I am very concerned that I was put under such pressure not to reveal the regulator's findings.
My only hope in speaking out is that the regulator will change. It must listen to people suffering negative side-effects of drugs and to be more accountable to patients rather than to pharmaceutical companies.
Dr Alastair Benbow, European medical director at GlaxoSmithKline, says: "We remain fully confident in the effectiveness of Seroxat, an important medicine that has helped many millions around the world lead fuller lives."
Last week I resigned from the Government's watchdog on anti-depressants after it tried to cover up its own ten-year failure to identify serious side-effects of the controversial drug Seroxat.
The Medicines and Healthcare Products Regulation Agency found from information that had been in its possession for more than a decade that high doses of the anti-depressant can lead to aggression and thoughts of suicide.
But instead of revealing the truth to the 17,000 people taking high doses and the other half-million Britons on a safer dose, the MHRA sat on its findings.
Astonishingly, I was actually threatened with legal action by Professor Kent Woods, chief executive of the MHRA, if I revealed this.
Mind, the mental health charity, has been tracking Seroxat for a decade and found it to be the most problematic anti-depressant. Side-effects include nervousness, aggression, irrational thoughts and, in some cases, feelings of suicide.
Although Seroxat has been effective for thousands suffering from severe depression, there are many who blame tragic events, including murders and suicide, on it. Last year, BBC's Panorama showed that - despite denials from the manufacturer - people can get hooked on Seroxat and suffer terrible withdrawal symptoms when trying to come off it.
Manufacturer played down side-effects
The drug's manufacturer, GlaxoSmithKline, has sought to play down its side-effects, denying until last year that it could be addictive. Mind - along with dozens of people suffering the drug's side-effects - held a demonstration last June outside MHRA's headquarters in London, calling for the drug regulator to take action.
By the end of that week, I had been invited to join its expert panel to look at the effectiveness of the so-called "happy pills", selective serotonin re-uptake inhibitors (SSRIs) - drugs prescribed to tackle depression, anxiety and other psych-ological problems. They include Prozac and Seroxat.
I hoped we could issue clear guidance to doctors on how to prescribe SSRIs safely. But my colleagues at the regulator, all from the medical establishment - doctors, academics and psychiatrists - had different ideas. They appeared more interested in putting their reputations, and those of drugs companies, before the safety of patients.
In October, the MHRA reviewed data from the earliest trials of Seroxat. The information was supplied by GlaxoSmithKline in the late Eighties, and it was the MHRA's responsibility to analyse the statistics to inform its decisions.
In four reviews of these statistics over ten years, the regulator had failed to pick up the vital information that any dose of Seroxat above 20mg a day doesn't work any better but significantly increases the side-effects.
Hundreds prescribed dangerous levels
Some 17,000 people were prescribed more than 20mg of Seroxat last year. But the panel wanted to kick the findings into the long grass, passing it to European regulators. It would take months. In that time, hundreds would be prescribed dangerous levels of Seroxat.
It was then that Professor Woods made clear I faced prosecution if I revealed what the regulator had found, citing the need to protect the "commercial confidentiality" of drugs firms.
On the MHRA website, Professor Woods defends the watchdog, saying its advice is backed by clinical data.
A few days later, I went to see Health Minister Lord Warner to tell him of my concerns. He said he would speak to the regulator, and soon after they reluctantly published the findings.
Their statement "reminded" doctors not to prescribe more than 20mg, as if it had been common practice all along. Previously, the MHRA's recommended "safe" dose was 20mg to 50mg a day.
I resigned. If a regulator will not own up to its mistakes, who knows if data about other drugs has not also been overlooked, with potentially fatal results.
Regulators are supposed to be a stop-check for safety issues. But at the MHRA, many of the people who work there or advise it have ties to drugs firms. Some have shares in the companies, research departments funded by them or receive fees for advice.
The only protection is a musical chairs system where you leave the room if you have an interest in the drug being discussed or its manufacturer, or you can stay but not vote.
Need for independent inquiry
There is an urgent need for an independent inquiry into the MHRA. The Government must also change its culture of secrecy.
Seroxat is far too extensively prescribed, especially for mild and moderate depression. But anti-depressants - including SSRIs - do work, and can prevent suicides in severe cases. However, they are not wonder drugs.
GPs should clearly outline all the options to sufferers and anti-depressants shouldn't be the automatic answer. If vital information such as that the MHRA tried to cover up is not released, these decisions cannot be fully informed.
Likewise, patients on Seroxat concerned by my findings should consult their doctor before adjusting their medication.
Mind does a lot of work with the Government, and we have a good relationship. But I am very concerned that I was put under such pressure not to reveal the regulator's findings.
My only hope in speaking out is that the regulator will change. It must listen to people suffering negative side-effects of drugs and to be more accountable to patients rather than to pharmaceutical companies.
Dr Alastair Benbow, European medical director at GlaxoSmithKline, says: "We remain fully confident in the effectiveness of Seroxat, an important medicine that has helped many millions around the world lead fuller lives."
Subscribe to:
Posts (Atom)
Please contact me if you would like a guest post considered for publication on my blog.