MHRA CEO KENT WOODS… LIES TO SEROXAT VICTIM EXPOSED
I have received a response from the CEO of the MHRA regarding the recent teratogen correspondence
I have replied to Kent’s email and will show you the response within the next 48 hours.
Meantime, here is Kent Woods email to me.
Dear Bob
I am responding to the various e-mails you have sent to the Agency recently – in particular, to the open letter to me which you posted on your web site.
You have complained that I have ignored your correspondence to me. When we met in September last year, I explained after our long (and I thought productive) discussion that I would not be able to reply to your e-mails personally but that they would receive attention. A great quantity of correspondence does come to my office every day and as a routine it is passed on to the most appropriate person in the Agency for a response, although I do see most of it.
At our meeting in September 2008, we discussed in detail your views on Seroxat withdrawal and as promised my staff took this matter both to the BNF and to NICE, who were in the process of revising the guidelines on management of depression. You will no doubt have seen that the recently published NICE guidelines deal with withdrawal in some detail.
For the record, it should be stated that you have had personal meetings with several senior MHRA staff to discuss your concerns – chief executive, Director of Communications (twice), senior Communications manager (twice; once travelling to you), senior pharmacovigilance scientist (twice) – and numerous letters, e-mails and phone calls from them which have been both detailed and civil. To suggest that you have been ignored is, quite frankly, nonsense.
On the subject of paroxetine in pregnancy, you clearly have your own strong views and send us bits of evidence which support those views. Like other regulatory agencies, we must consider all the evidence, and the likely balance of benefit and harm, when we give advice to prescribers and patients. That scientific process is quite different from what a lay jury does in a civil court, weighing the arguments of the lawyers for plaintiff and defendant, and it is not surprising that the conclusions may be different. The legal and scientific understanding of ‘causality’ differs; the Agency sponsored a legal conference on this very point during the summer.
I take offence at your suggestion that when we disagree with you it must be because we are idle, indifferent or in the pockets of the pharmaceutical industry. No agency in the world has been more active during the past 20 years in assessing the risk-benefit evidence on SSRIs and updating advice to prescribers and patients as necessary. No agency has investigated a pharmaceutical company as thoroughly as MHRA has investigated GSK. Our actions throughout have been driven by the scientific evidence and by the legal powers we are given by Parliament. We take great care to prevent any conflict of interest which might influence judgments made or decisions taken by agency staff.
HERE IS WHERE KENT WOODS LIES,
READ PARRAGRAPH BELOW AND SEE THE TRUTH HERE… See what Paul Flynn M. P. for Newport West, has to say about it by visiting this link www.paulflynnmp.co.uk/seroxat04.htm KENT WOODS WORKED AT GSK SEROXAT MAKERS FOR 27 YEARS. did he also tell the Seroxat investigations about his working for GSK for all those 27 years while being the MHRA CEO ? someone should inform the seroxat investigation team, has woods committed perjury ?
KENT WOODS: "My entire career before I joined the MHRA was spent in Universities" doing research on medicines and working as a physician in the NHS. I do not have an industry background. In 30 years of medical practice I saw the severe impact of depressive illness on people’s lives and also the increased safety of SSRIs compared to the anti-depressants which came before. Used well, their benefits outweigh their potential for harm. Our aim as an Agency is to help prescribers and patients use them with the greatest benefit and the least potential for harm.
I fully understand the human impact and the intense need to find some explanation when a baby is born with a congenital defect. But 2-3% of babies are born with some form of congenital abnormality, even in the absence of any drug exposure in pregnancy. Separating out chance events from a true teratogenic effect of a drug is extremely difficult. Being too willing to blame a drug can deprive future patients of the benefits of anti-depressant treatment when they really need it. There are no easy answers when the evidence is ambiguous. That is why opinions can differ. As a regulator I have no interests, financial or otherwise, in any company or industry. This agency is solely concerned to do what is best for public health..
You can choose not to believe any of this and your recent letters and blogs indicate that you will not want to change your fixed ideas. My colleagues and I have tried in good faith to respond to your concerns in an honest and constructive way. I am disappointed at the tone with which you choose to end this contact. We will continue to monitor SSRIs closely and to take any further action, or issue any further advice, which is necessary on public health grounds. We will respond to you in line with our responsibilities as a public body but abusive e-mails are likely to be ignored.
You can take this as an open response to your open letter to me, but if you put it on your web site you must publish the whole letter and not selected extracts.
Yours sincerely
Kent Woods
Chief executive
For further details please visit
http://fiddaman.blogspot.com/2009/12/ceo-of-mhra-kent-woods-responds-to.html