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
1
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
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.
__________
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…
September 9, 2008 — admin
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:
- Psychological and bodily dependence on a substance or practice which is beyond voluntary control
www.painaction.com/painaction/Glossary.aspx
- An illness in which a person seeks and consumes a substance, such as alcohol, tobacco or a drug, despite the fact that it causes harm.
www.nationalpainfoundation.org/MyTreatment/MayoClinic_glossary.asp
- A primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. …
www.painsweb.com/articles/3/1/Pain-Glossary/Page1.html
- Dependence on a chemical substance to the extent that a physiological and/or strong psychological need is established.
www.snowdenmentalhealth.com/glossary.mgi
- Is characterized by the repeated use of a substance or behavior despite clear evidence of negative consequences resulting from the use of the substance or behavior. Addiction usually has two components – physical addiction and psychological addiction.
methaddictionanddrugs.com/t-glossary.aspx
- The condition of being habitually or compulsively occupied with or or involved in something. Read about addiction in Wikipedia Addiction
www.treatmentsolutionsnetwork.com/dictionary.aspx
- dependence on a substance (such as alcohol or other drugs) or an activity, to the point that stopping is very difficult and causes severe physical and mental reactions
www.hsc.wvu.edu/som/cmed/alcohol/glossary.htm
- A behavioural pattern characterized by compulsion, loss of control, and continued repetition of a behaviour or activity spite of adverse consequenses.
www.mherc.mb.ca/gloss.html
- Psychological or emotional dependence on the effects of a drug.
www.pbs.org/secondopinion/episodes/chronicpain/medicalglossary/story425.html
- a state of being dependent on a certain substance, which is harmful or dangerous for the physical or mental health of the person, for his social well-being and economical functioning of the subject
library.thinkquest.org/C0115926/glosary.htm
- A compulsive disorder caused by long-lasting chemical changes in the brain.
www.brooks-law.com/CM/Custom/Definitions.asp
- physical and psychological dependence, including tolerance of a drug, withdrawal symptoms when use is stopped, and persistent relapses following reversal of physical dependence.
www.adha.org/CE_courses/course3/definition_of_terms.htm
- Loss of control with respect to use of a drug, taking the drug despite related problems, and a tendency to relapse.
www.careinaction.com/resources_dict_a.html
- a disease, influenced by genetic, psychological, social, and environmental factors, that changes the normal way the nervous system works. …
www.duragesic.com/duragesic/patient_glossary_index.html
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I stopped in at NARSAD’s site last night, and Martin Keller is Still listed on their Scientific Council, ….. along with Nemeroff and Schatzberg, ….. and Hot Damn but did it Ever feel good to hit the post button.
I hope life’s treating you well.