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.
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