September 2008 : Seroxat Update


In this post, I’m going to write about two very important developments in the ongoing Seroxat Scandal which happened during this month of September 2008. 

The tireless Seroxat campaigner and author of Seroxat blog “Seroxat Sufferers Stand Up And Be Counted”,

http://fiddaman.blogspot.com/

Bob Fiddaman, managed to secure a meeting with the MHRA (UK medicine regulators), the minutes of the meeting can be found here :

http://fiddaman.blogspot.com/2008/09/meeting-with-mhra-minutes.html

Guidance on the Management of Withdrawal from 

Seroxat (Paroxetine) and Other SSRIs 

Notes of a meeting held at MHRA on 2 September 2008

Present:

Robert (Bob) Fiddaman (RF), Campaigner, Author of Seroxat Sufferers Blog

Prof. Kent Woods (KW), Chief Executive, MHRA

Sarah Morgan (SM), Head of Pharmacovigilance Risk Management, MHRA

John Watkins (JW), Communication Manager, MHRA, acting as secretary


1. RF said he would like to discuss problems of withdrawing from Seroxat. He said that though his 

concerns centred around Seroxat, he recognised that other SSRIs posed similar problems 

which ought also to be addressed. 


2. He produced copies of the Patient Information Leaflet (PIL) for Seroxat in which he had 

highlighted the 32 places where patients were told to talk with their doctor about various 

issues. He felt that too much of an onus was put on doctors, many of whom did not know 

enough about withdrawal problems and their management. 


3. In answer to a question from KW, RF agreed that the focus of the meeting should be on the 

information going to doctors and perhaps also on their training. 


4. KW noted that doctors do not generally refer to the PILs, nor indeed to the similar but more 

technical Summaries of Product Characteristics (SPCs). Instead, they use the British National 

Formulary (BNF), revised twice each year, and guidance produced by NICE. The NICE 

guidance on the management of depression was currently being revised; a draft is due to go out 

for public consultation in December 2008 with a view to publication in June 2009. 


5. He emphasised that MHRA controls neither the BNF nor NICE in any of the matters they cover, 

but the Agency can and does make suggestions to both organisations about the information 

they provide.  


6. RF illustrated the practical problems encountered by patients in withdrawing. He offered each of 

the others a jelly baby and asked them to bite off one-third. No problem. He then produced 

some Tic-Tacs (mints). It was immediately acknowledged that biting off a third was very difficult. 

Likewise with a Seroxat tablet, said RF. The liquid preparation was much better suited to dose 

tapering but doctors seemed largely unaware of it. He outlined his own experience of 

withdrawing over a period of 21 months. The liquid, administered through a syringe, helped that 

process, though – for him – not even tapering took him beyond the point where he felt he had to 

“go cold turkey”. He did that because he did not want the drug to continue to have a hold over 

him. 


7. During withdrawal he experienced severe “zaps” in his brain. He described his dependence on 

the drug as an addiction, and exemplified that by relating his feelings of wanting to “rip the shop 

apart” if it turned out that they were out of stock.  


8. KW noted that the term “addiction” ought to be reserved for circumstances which typically 

entailed cravings leading to increase in dosage, but suggested it was less important to argue 

about terminology than to acknowledge, as he did, that there are significant problems 

associated with withdrawal; the issue was how best to manage withdrawal. He noted that, as 

with benzodiazepines, those SSRIs which both act and disappear more quickly are more likely 

to pose problems with withdrawal. He did not know whether a switch to slower acting SSRIs had 

been researched as a potential solution, as it had proved to be for benzodiazepines. 

 9. KW said he was aware that RF had had some very good support from his doctor and wondered 

how widespread such support would be. RF believed that many doctors would not be able to 

provide that level of help, due to not knowing how to manage withdrawal. RF had sent the 

Agency a very large number of personal testimonies about difficulties that others had 

experienced during withdrawal. 


10. RF pointed to guidance on withdrawal produced by Dr David Healy; KW said he had seen it but 

his concern about any guidance would be whether “one size fits all”, given the range and 

diversity of withdrawal experiences. That should not however prevent the development of 

authoritative guidance. 


11. RF asked what authority MHRA had to issue warnings. Could it for example require warnings to 

be put on packaging like those on packets of cigarettes?   


12. KW replied that the place for warnings to patients is within the PIL. If they were very prominent 

on the packaging then that might well deter patients who really needed the medicine from taking 

it. The Agency has control over PILs. KW outlined the improvements to PILs in recent years, 

largely due to testing them with users; a programme which will end very soon has been 

reviewing and revising the PILs for all medicines. RF acknowledged that there had been 

significant recent improvements in the Seroxat PIL. KW noted that there is still room for 

improvement in PILs but the Agency is now starting to explore other initiatives relating to PILs. It 

might for example become feasible to ensure that PILs are available to patients beforehand 

rather than at the time they start to take their medicines. 


13. RF wondered whether MHRA had thought of including Yellow Cards with or in the PILs. SM 

replied that we had considered asking pharmacists to include them in the bag holding the 

package. KW noted that every edition of the BNF had a Yellow Card at the back but there was 

no obvious place for making it available to patients other than placing them in pharmacies and 

GP surgeries. Reports from patients were still relatively new. So far only about 10% of all 

reports come from them, but the quality of the information they contain is every bit as good as 

that from healthcare professionals. 


14. KW asked RF what he thought of the Seroxat PIL’s Section 5, “Stopping Seroxat”. Early in the 

section it says “When stopping Seroxat your doctor will help you to reduce the does slowly …”. 

RF felt that this was over-optimistic. He also felt that the advice about dosage reductions of 

10mg a week (which SM noted was based on clinical trials) was too large an increment in view 

of his own experience – he needed to reduce by 1mg a week, only practicable with the liquid – 

and the experiences of others. And he felt that the signposting to the liquid form, “It may be 

easier for you to take Seroxat liquid during the time that you are coming off the medicine” was 

inadequate. SM agreed that steering patients towards the liquid could be made more obvious; 

and it could be helpful if such a steer was also given to doctors, in some document such as the 

NICE guidance1.  


15. Referring again to the management of withdrawal in relation to benzodiazepines, KW read out 

the advice on management of withdrawal for that class of drugs that is in the current edition of 

the BNF. RF said he would have found it very helpful if that kind of advice, but about Seroxat / 

SSRIs had been available to him at the time he started to withdraw. He wondered how many 

doctors used the BNF. KW reckoned that almost every doctor will use it, with many of them 

referring to it frequently. When he was a clinician, he always carried around a copy of the BNF 

in his coat pocket. 


16. KW thought that the inclusion of similar advice in relation to SSRIs could be suggested to the 

BNF. It might also be suggested to NICE for their guidance. And a potentially useful way of 


 There was also some discussion about how to interpret the list under “Likely to affect up to 1 in 10 

people”. JW wondered whether each effect in the list would affect up to 1 in 10 but SM said it meant that 

up to 1 in 10 could expect to experience one or more of the effects in the list. 


drawing prescribers attention to any new advice that emerged would be MHRA’s monthly Drug 

Safety Update. KW again stressed that though we might make suggestions about this to the 

BNF and to NICE, it would be for them to decide. While MHRA’s primary role is to regulate 

industry – with no jurisdiction over doctors, it is within the remit of both the BNF and NICE to 

inform and indeed to influence doctors. 


17. RF asked whether MHRA would talk with David Healy. KW said he would be happy to have that 

happen. But it would be useful if others with experience of managing withdrawal were also 

consulted. Those present at the meeting could not immediately identify anybody else in the UK 

but MHRA would try to do that, perhaps with the help of one of its Board members. 


18. RF asked whether the management of withdrawal could be covered in the training of doctors. 

KW explained the difficulty any organisation would have in influencing medical schools when 

each school determines its own curriculum. 


19. RF enquired how the Agency kept up to date on research and indeed legal issues surrounding 

Seroxat. Had the Agency for example been aware of the “Glenmullen report” before he drew 

attention to it at a time when the Agency was still investigating GSK? KW could not recall at 

exactly what stage he personally became aware of the document but assured RF that the 

Agency kept track of developments generally, not just in the context of a particular investigation. 

SM described how her group undertake a weekly review of the literature in respect of all drugs, 

covering all the major journals. And pharmacovigilance also takes account of clinical trials and 

trends in Yellow Card reports. 


20. The meeting concluded by recognising that though the focus had been on Seroxat, there were 

other SSRIs that posed similar problems, and that changes in prescribing practices, such as a 

reduction in prescriptions for Seroxat in recent years and increases for other drugs, for example 

Venflaxine, mean that some of the issues deserve to be dealt with in terms of the class of drugs 

rather than in relation to individual members of that class.  

______________________

One would have to wonder why the MHRA agreed to meet with Bob Fiddaman, considering his voice and his blog regularly draws attention to the failings of the MHRA and GSK in regards to the Seroxat Situation.

Some people might believe this to be a feeble attempt of good PR on the part of the MHRA, others might think that maybe the MHRA are finally beginning to listen to patients concerns about Seroxat, a drug which in my opinion is one of the most dangerous drugs ever licensed. Seroxat caused me and my life much harm, and it has caused immeasurable suffering to tens of thousands of people worldwide since it came on the market in 1991. A clue as to why the MHRA might have granted Bob Fiddaman some time to discuss the continuing problems of Seroxat might be found in the recent release of a PDF document from the MHRA. This document was released shortly after Bob’s meeting with the MHRA. The document is basically an online study commissioned by the MHRA and conducted by a marketing company. The intention of the study was to understand the power of information online , how it is distributed and where it comes from. From reading the conclusions of the study, it seems Bob Fiddamans blog has consistently appeared high on online searches and search engines when included in the context of the words “MHRA” and “Seroxat”. Many other Seroxat awareness blogs also share a massive proportion of the search indexes. Is the MHRA more concerned about its own reputation than patients suffering on Seroxat? 

A link to the MHRA Online Seroxat research report can be found here :

http://www.fileden.com/files/2008/5/6/1899375/Market%20Sentinel%20Report.pdf

and Seroxat Campaigner Bob Fiddamans take on the report can be found here :

http://fiddaman.blogspot.com/2008/09/influence-of-bloggers.html

THURSDAY, SEPTEMBER 11, 2008

The Influence of Bloggers

Are you watching Glaxo?
The MHRA started taking an interest in blogs fairly late last year. For several months they searched for blogs relating to MHRA and tried to make sense of what at first was a rather bewildering landscape. Early this year they sought some professional help in understanding the blogosphere. The MHRA commissioned a company to do some research, using tools not available to them. In the few months leading up to the commissioning it had become obvious that Seroxat was the issue that dominated the blogosphere in relation to MHRA. Therefore they decided to seek to understand a single dominant issue through the company’s mapping techniques rather than risk a more complex but less intelligible picture of all the blogs relating to MHRA.
__________________________________________

Two other admirable blogs “furious seasons” and “seroxat Secrets” have also addressed these recent Seroxat developments , both sites are well worth checking out :

From the Excellent Furious Seasons , Phil Dawdy writes :

http://www.furiousseasons.com/archives/2008/09/british_fda_report_finds_healthcare_blogs_as_influential_as_old_media.html

September 12, 2008

British FDA Report Finds Healthcare Blogs As Influential As Old Media

Earlier this year, the MHRA–Britain’s FDA–got a report from a British web consulting firm analyzing the influence and popularity of various online information sources for people interested in learning more about Seroxat (Paxil’s UK name) and the MHRA. It’s not clear why the MHRA commissioned the study, but apparently the agency realized it was being pounded by numerous British bloggers over its role in letting a problematic anti-depressant stay on the market with few warnings for consumers about withdrawal problems and other side effects, so the agency apparently wanted to learn how much impact all these newfangled blogs were having.

What the MHRA learned from this report (6.4 MB pdf) is that blogs and the people who write them are as influential as many traditional media websites and traditional corporate websites and are more influential than are many well-financed healthcare websites such as WebMD. The report only looked at how influential blogs were as regards the MHRA and Seroxat (as opposed to the FDA and Paxil) to give the whole thing a British slant.

Included among influential and popular blogs in no particular order were Pharmalot (US), Seroxat Sufferers(UK), Seroxat Secrets (UK), the Carlat Psychiatry Blog (US),Furious Seasons (my All-American blog), Clinical Psychology and Psychiatry (US) and Health Care Renewal(US). For popularity and influence, we ranked right up there with wire services, the London Times and the Wall Street Journal and only slightly trailed the BBC and the New York Times. This is all quite astonishing when you think about it–underfinanced blogs having as much influence as the WSJ! Unthinkable! US blogs that barely mention the MHRA (and usually write about Paxil not Seroxat) being more influential than WebMD–the world has come undone for sure!

You can skim the report for yourself and draw your own conclusions. Obviously, there are going to be biases in how the report’s analyses were done and what search terms were used and so on (you’d get different results if the consultants had gone after the FDA and Paxil), but what the MHRA has learned reminds me of what political parties and the mainstream media learned about US political blogs in 2004 and that is that they cannot ignore them. The reading public has voted with its eyeballs and has decided that blogs matter, and matter in some cases much more than Big Pharma’s own websites and more than pharma-funded health care sites like WebMD. And that my friends smells like victory.

I simply cannot wait until the FDA figures this phenomenon out for itself. Advertisers too.

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The Excellent “seroxat secrets” also makes some very interesting points on these issues here :

http://seroxatsecrets.wordpress.com/2008/09/09/come-on-mhra-admit-seroxatpaxil-really-is-addictive/

Come on MHRA – admit Seroxat/Paxil really is addictive…

No one seems to want to admit Seroxat/Paxil is addictive… not Glaxo, not the FDA, not the World Health Organisation, not the MHRA… it seems the only people who are prepared to stand up and say Seroxat is addictive are those of us who actually took the drug.

I thought I was right to say I was addicted to Seroxat because I was totally dependent on the drug as I found I could not stop taking it without suffering terrible physical and mental withdrawal symptoms… a simple and straightforward enough premise. In fact The Oxford Pocket Dictionary of Current English (date: 2008) agrees with me, defining addiction as: the fact or condition of being addicted to a particular substance, thing, or activity.

In a recent meeting with Bob Fiddaman, Kent Woods of the MHRA disagreed as he repeated the big pharma mantra about the definition of ‘addiction’: “8. KW noted that the term “addiction” ought to be reserved for circumstances which typically entailed cravings leading to increase in dosage…”

Well Kent, I’ve got some news for you – I have no time for semantics designed to protect drug manufacturers (or the MHRA) while you sit there and ignore patients’ experiences.

I was addicted to Seroxat. It is an addictive drug.

Here are some more definitions of Addiction: