The Risks Outweigh the Benefits

An Interview with Bob Fiddaman

Robert Fiddaman1, Gary L. Hart2, Michelle Hart3, Matthew Holford4

Foreword

As doctors, we sell our services under the banner of science. Many patients
have begun to question the quality, transparency and honesty of our science.
Unfortunately, they are doing so with good reason.

When our patients lose trust in the integrity of the science we may never be
able to recover our status as a profession. We ignore questioning patients at
our peril.

Bob Fiddaman is a question-asker. He is persistent and he is angry. He is also

right.

We need to start listening.

Aubrey Blumsohn
MBBCh, PhD, MSc, BSc(hons), FRCPath

Q: Bob, your blog "Seroxat Sufferers" seems to have become a flagship in the
ongoing war of words with GlaxoSmithKline, (“GSK”)5, the Medicines and
Healthcare products Regulatory Agency, (“MHRA“)6, the Department of
Health, and so on, concerning GSK's SSRI antidepressant7, Seroxat8. You've
built yourself a reputation as being belligerent and irritating; or forceful and
determined, dependent upon which side of the fence one is sat. Your interest
in Seroxat is well-documented, on your blog, as being consequent to personal

1
Bob Fiddaman is the author of Seroxat Sufferers [http://fiddaman.blogspot.com]. He has been
raising awareness for three years regarding the safety and efficacy of Seroxat.
2
Dr. L. Gary Hart, PhD is an endowed professor in the College of Public Health at the University of
Arizona and Director of the Arizona Rural Health Office.
3
Michelle "Shelly" Hart is a Registered Nurse currently writing a book on Paroxetine withdrawal after
having had a severe withdrawal reaction stopping the medication.
4
Matthew Holford is a Law graduate and Financial Compliance professional, whose interest in SSRIs
began in 2004/5, when he experienced a severe reaction to fluoxetine.
5
GlaxoSmithKline was formed in 2001, through the merger of Glaxo Wellcome and Smithkline
Beecham, a merger overseen by the recently departed CEO of GSK, Jean Pierre Garnier.
6
The MHRA “is the government agency which is responsible for ensuring that medicines and medical
devices work, and are acceptably safe.” It was created in 2003, through the merger of two government
agencies, the Medicines Control Agency, and the Medical Devices Agency.
7
Selective Serotonin Reuptake Inhibitors, or SSRIs, are said to relieve the symptoms of depression by
blocking the reabsortion of serotonin, once a chemical message has been passed across a synapse.
Doubt has been cast upon this hypothesis, to the extent that manufacturers acknowledge that it is not
known how SSRIs work, which assumes that they do work.
8
Seroxat is the name under which paroxetine hydrochloride is marketed, in the UK. The drug is also
known as Paxil, Aropax, Deroxat and Motivan.
experience. Why don't you start by telling us a bit about that?

Well thanks for the 'big-up' on the blog, there are others that blog just as
well... if not better than I. Personally I think it is because I add my name to
most of my rants that the blog has become infamous with all those
connected with GSK, the MHRA et al... at least I like to think it has. 'Seroxat
Sufferers Stand Up And Be Counted' is quite a mouthful, most people now
refer to it as “Fiddaman's blog” - People could call it Leticia's blog for all I
care... The main objective was, and still is, to create awareness.

I don't often touch on my own personal experience with Seroxat, particularly

on my blog as there are far more important issues to come across.

Basically, I was prescribed Seroxat by my GP9 due to 'depression' - it was

work-related and kind of spiralled when my former employers put me on to a
'Long Term Absence Register' because I had developed an illness that didn't
allow me to perform the job I was employed for (Osteoarthritis of the hips).
The 'Long Term Absence Register' was basically set up to leave employees
without pay and without being able to claim for benefits. It had a strain on
family life and Seroxat was deemed to 'fix' that problem.

Seroxat took away the pain of not being able to provide for my family, in fact
I didn't really care much about anything. I became devoid of any human
emotion other than sadness, it was an unexplainable sadness though, you
know bouts of crying when I really didn't know what I was crying about.

I first noticed withdrawal symptoms when my family and I went on holiday -

an annual trip to the mother-in-laws caravan. At the time I thought I had
sunstroke - strange shooting sensations across my head and a feeling of
nausea. However, victims of sunstroke suffer because they get too much sun
I had been on holiday for two days, two days in June where it had rained
constantly. I actually wrongly thought that there would be no need to take
my dose as I was away on holiday and away from everything that reminded
me of the employment thing. It was my wife (now divorced) who asked if I
had taken my medication. Once I realised that the zaps were caused by me
missing a dose, I immediately started again. The zaps then stopped.

The two week holiday was a respite from the problems on the work front,
however I didn't feel I was myself on the holiday. I didn't drink alcohol and
couldn't get into the spirit of things. Eventually the sun did come out but
sitting in it seemed to increase my agitation. Sudden loud noises were
beginning to irritate me - unavoidable when you are sitting around a pool
and kids are screaming and splashing around, basically enjoying themselves
much to the increasing annoyance of myself.

I'd go for walks alone instead of sitting at the beach or around a pool - I
didn't like the feelings I was getting at these loud noises - I would clench my
fist and hold in the feeling of anger. I became very tired way too easily - one
minute I was wide awake, then next I was 'comatose'. I was waking but not
feeling that 'refreshed' feeling one does after 8, 9 sometimes 10 hours sleep!
Sure, when we are depressed our bodies tend to shut down and sleep is a
9
“General Practitioner” is the term applied to primary care doctors, in the UK. “Family Physician,” or
“General Internist” would be the equivalent terms, in the US.
common trait in the depressed... so I've been told. But this was more than
sleep, this was literally like hibernation!

The early days of taking Seroxat have become a blur, there isn't much I can
remember.

I started to become violent in my sleep. I remember my then wife telling me

that I had woken next to her in the middle of the night. I had climbed on top
of her and placed my hands around her throat, with all her strength she
threw me off - I, she said, rolled over and continued to sleep. I had no
recollection that this event had taken place when I woke in the morning. On
another occasion I lashed out at her during sleep. Again, I had no
recollection of this incident. Things were strained between us and it was
decided that I sleep elsewhere, the couch downstairs was the obvious choice
as I didn't want to get into the same bed as my children through fear of
attacking them whilst I slept.

Sudden loud noises became a real problem for me, with three children in the
house I found it intolerable and would have to leave the room, sometimes
house, just to get away from the noise. I started to feel alienated (distanced)
from my own family. The children tried their best but how can children play
without making noise. They are grown up now and my eldest recently told
me 'Dad, it was like literally walking on egg shells'. That saddened me
because it was something that was out of my control and something that
had only started when I took Seroxat.

As the nightmare continued, my employers agreed to finish me off and an

agreement was reached for a retirement package. One would think that a
sudden windfall of cash would have brought me back into reality. It didn't. I
was numb and at times I thought I was on a different planet with
back-to-front time zones. Night sweats, confusion, lack of empathy and
blurred or delayed vision became common. I felt like a prisoner in my own
home. People complain about Seroxat withdrawal... all of the above
happened when I was not withdrawing.

Things came to a head and I tried to take my own life by swallowing 20 or so

Seroxat tablets. My then wife was on holiday with a friend. I just wanted out,
I didn't care for anything, I had put weight on, my marriage was a sham, my
children would take a wide berth when walking past me and would rarely talk
with me for fear of me 'snapping'. I just did not care about anything, a
complete lack of empathy for everyone and everything. I wanted the old me
back, wanted my children to have a dad again. I couldn't see how that could
happen. Here I was with a lump sum of money yet I was considerably
withdrawn from reality. My world seemed my own and nobody else's. I didn't
want anyone else to come into my world because I knew they wouldn't like it.

After I swallowed the tablets I phoned a friend who lived nearby - it was one
of the rare occasions where reality had dawned and I realised that I had
made a huge mistake. My friend phoned an ambulance and I was admitted to
hospital and kept in for observation overnight.

A few months went by and my GP had prescribed me the liquid form of

Seroxat, a sickly orange liquid administered with an oral syringe. As I recall, I
think I had told him that I wanted [needed] to come off Seroxat as it was
making my life a complete misery. I think I had tried tapering by halving the
tablets or taking one instead of two. It's all quite blurry. Basically, I had no
guidance, nobody could tell me how to slowly taper and what programme to
follow. The manufacturer [GSK] offered no guidance on the patient
information leaflet, I think the only guidance they offer to day is that 'you
must taper slowly' or words to that effect.

I moved out of the marital home, leaving my 3 sons behind me. Again, I felt
no emotion. I moved across the city to live with my sister. She educated
herself on withdrawal problems and made things really comfortable for me. I
owe her a great debt. I lived with her and her two children for about 5
months before being given keys to a one bedroom council flat just around
the corner from her. In fact, part of the reason I was able to live so close to
her was because the Housing Department had agreed that I needed someone
close by to help me through withdrawal. I guess I have GSK to thank for my
one bedroom council flat.

I was elated when I got my own place, it meant I could see my children again,
more importantly show them how their dad was getting better because I was
tapering - and had been during my time spent living with my sister.

The zaps were still with me as was the irregular sleep patterns but I was
happy in myself that I was 'getting there'.

18 months from 40mg to 22mg and I was reading comments on the internet
from GSK employee, Mary Anne Rhyne, claiming that “discontinuation
reactions” last for about 2 weeks. Hmmm, longest two weeks I have ever
known!'

Enough was enough, so I decided against my GP's wishes to go cold turkey.

He told me to keep in touch on a regular basis and we did via email. My GP
had sometime previously stopped prescribing Seroxat to new patients
because he had witnessed what I had gone through and had read documents
that I had read on the internet and printed for him.

I still allowed my children to come see me for the first few days but then
things got really bad. I became violent in my thoughts - I yearned
confrontation.

Days and nights passed and I would control the zaps jolting through my
body by wrapping a soaking wet ice cold towel around my head. I'd also
wrap ice cubes in a smaller towel and place this on the back of my neck.
This helped somewhat with the zaps. I'd go for walks in the middle of the
night - As I recall this was during the months of Feb/March and it was a
particularly cold year. I would walk with just a t-shirt on - the cold biting at
my naked arms - I didn't care - anything to take away the zaps – Anything!

I was living in a nightmare, although I had no fear, no fear at all, quite the
contrary. I would walk through a country park that backs on to where I live,
walk through during the early hours of the morning. I didn't care if I was
stopped by gangs of youths, I would 'let them have it' - this was my mindset
- I wanted violence.
It was a rough journey and one that I would never recommend to anyone. I've
lost friends because of Seroxat, I've lost the woman I married, more
importantly [to me] I lost a very precious moment in any father's life - I had
missed my children growing up. I locked myself in my flat and after a period
of about 3 months [cold turkey] the demon had finally been banished. The
clouds had parted and for the first time in six years I felt like Bob Fiddaman
again.

The withdrawal hell of Seroxat doesn't look like much when reading about it.
One has to experience it at first hand to fully understand just how
debilitating it can be.

So there you have it, Matt. GSK messed my life up and are continuing to
mess with other people’s lives. I don't want them to do that so I write about
them.

In all I was on the liquid Seroxat for a total of 18 months, weaning down
from 40mg per day to 22mg per day - it was a long process but It was
something I needed to do. This drug had control of me, my thoughts, my
emotions, dare I say it, my whole life.

Q: The issue of side effects is an extremely controversial one - you mentioned

withdrawal and suicidality, there, which I know are regarded as issues with
the drug, now, even though it is still denied that suicidality, for instance,
impacts the over-30s, and that it is still claimed, officially, that the severity
of withdrawal is overstated. You mentioned that you connected your
withdrawal symptoms with the drug, almost instantly. What made you think
it was the drug, and not, say, a virus, or something you ate?

Well my initial reaction to the feeling of 'sun-stroke' as mentioned in my first

answer to question 1 was that it was just that - Sun stroke. It was only when I
added the dots and crossed the T's that I realised that here had been no sun
at all, therefore sun stroke could be ruled out. At the time I was 35 or 36 I
think and had gone through life as your average Brit, contracting the usual
minor ailments, Influenza, Chickenpox, the common cold, et al. This feeling
of an electric-like sensation was very strange indeed. I could have been
wrong, it could have been something far more sinister like a brain tumour
but here I am 8 years on. What occurred after that [the 6 years on Seroxat]
would lead me to believe that it was an adverse reaction to Seroxat. If, at
that given time, it would have been listed on the patient information leaflet
(“PIL”)10, I doubt very much if I would have had to experience it because I
would have been very careful not to miss a dose. The PIL back then was
vague - it has slightly improved but is still of little use. Today GSK suggests
that a patient taper slowly. That's all well and dandy but how can one taper
slowly from a single tablet? GSK should amend the PIL and tell it like it is,
something along the lines of 'Patients may experience head zaps and jolts
through the body, this is a result of your brain crying out for more serotonin,

10
PILs became mandatory, in the UK, in 1996. Leaflets, providing information on drugs, had been
available prior to this, but this was done on a voluntary basis, and the information contained therein had
not been formalized. According to the MHRA, the PIL is a collaboration between the manufacturer,
which remains responsible for the wording, at all times, and the regulator, which approves it.
do not attempt to ride the storm because there have been many instances of
patients who have completely gone berserk when experiencing these types
of reactions. Your GP must prescribe you the liquid suspension form of
Seroxat, a form that we manufactured initially because people had trouble
swallowing tablets, Using the liquid is the only way to come off Seroxat for
some patients and we, as a caring company don't wish to see patients
suffering anymore that what they should'

I of course jest. The chances of GSK admitting they have a defective drug are
very slim. The whole withdrawal issue, if you pardon the pun, grinds my
teeth. Little is being done about it by our regulator [MHRA]. They tout the
yellow card system but have they themselves seen the flaws in it? Nowhere
does it ask the patient about what level of depression they have. The patient
is asked what they are taking their drugs for. If someone were to fill one
of these yellow cards in they would probably say -

DRUG: Seroxat -
SIDE EFFECT - Zaps -
YOUR ILLNESS - Depression.

The MHRA then go away and log it into their system of adverse reports about
the drugs they 'regulate'. The suited scientists stuck in the 60's, 70's and
80's will merely pass the 'zaps' off as part of the illness. It's absurd, it's
deeply flawed and is basically regulating bugger all.

Q: Yes, this issue of patients being told that what they believe to be
withdrawal is in fact their "condition" is one that I've seen mentioned, before.
Despite the prevalence of these "electric zaps", do you think that this a
matter of ignorance, on the part of frontline physicians? Incidentally, can
you illustrate the zapping sensation, for us - can you think of something
more mundane that non-patients might understand?

Well ignorance is bliss... or so they say. The MHRA, NHS, Physicians and
GlaxoSmithKline won't recognise withdrawal because it does not affect them.
It will only affect them if they acknowledge it because they will have a lot of
angry people banging down their doors saying 'We told you so'.

Passing withdrawal off as part of the illness is a classic example of this

facade. 'Hey mate you are ill, deal with it because we don't want to help you
get better' kind of attitude. The risk-benefit propaganda is something you
write about, Matt. They [MHRA, GSK, NHS] cannot tell us what the benefits
are of taking Seroxat, yet with a whim can say that the balance of Seroxat
helping the patient is better than Seroxat causing the patient damage or
adverse reactions. To recap: They all know about the severity of withdrawal
but choose to ignore it because of stubbornness rather than ignorance and,
in GSK's case, it would damage sales... bit late for that now seeing as one
only has to Google the word 'Seroxat' to find blogs such as yours, Seroxat
Secrets, GSK Licence To Kill and a host of many others.

'ELECTRIC ZAPS'

Imagine a light bulb 'fizzing' because it has a loose connection. Now put that
light bulb inside your head. Basically, Matt, it feels like your brain is frying. It
affects your vision and your balance. Many times, my attention was
distracted, to which I responded by turning my head so my eyes could see
what that distraction was. My head would get there a split second before my
eyes, thus causing dizziness. There would be times when I was supping on a
cup of tea and my whole body would 'twitch' - it felt like someone had
prodded me with an electrical charge. All of these whilst that bulb was still
fizzing inside my head. I used to walk around the room waiting for the next
jolt. I didn't want to turn my head because of the whole eye movement thing.
To try and sit still while all this was going on was nigh on impossible. It
would have been easier to stick pins in my skin, at least I could have
anticipated the pain - with the zaps you could never tell when they were
coming. Many hot drinks were spilled as yet another ripped through me. I
have never known a depressed person (without medication) to complain of
zaps ripping through his body - have you?

Q: So, if I held onto an electric stock fence, with an irregular, unpredictable

pulse, and played white noise at high volume, that would give me some idea?
Going back to what you were saying about withdrawal - doesn't GSK
acknowledge that 30% of all Seroxat patients experience withdrawal, now?
Do you think that's an accurate figure?

I'd be more prone to think that it was like being poked by a cattle prod only
not so severe. I couldn't estimate the level of 'Voltage' I got but it was
enough to make me drop things I happened to be holding. You know when
you wet the rim of a wine glass and rub your finger around it? Think about
the noise when it reaches its highest pitch... now imagine how irritating that
noise is. You got it? Well, triple that feeling, add a series of random muscle
spasms and you have a dose of the zaps. Throw a sudden loud noise in and
imagine your head caving in.

Yeh 30%. Quite where they get their figures from baffles me though - unless
they are reacting to MHRA yellow card reports? Put it this way, if a product
works we [the public] sing its praises. The manufacturer covers itself in
garlands and reap the rewards [money]. Glaxo have it both ways. I would
estimate that the negativity about this drug in the media and over the
Internet far outweighs the positivity about it. Glaxo still reap the rewards,
though the garland wilters - the money kind of comforts that blow though.

Glaxo may acknowledge that some patients experiencing withdrawal. A

single word on a patient information leaflet is just not good enough. It needs
to go into more detail or at least they need to set up a special hotline that
deals specifically with Seroxat withdrawal, after all it is their product that
causes the withdrawal. The upshot, Matt, is that Seroxat is addictive and
nobody can convince me otherwise, not Glaxo, not the NHS nor the MHRA.

18 months to taper from 40mg per day to 22mg per day? C'mon. I've read
stories of heroin addicts weaning off their poison more quickly than it took
me to wean off Seroxat.

Q: In answer to your earlier question, "no I've never heard of unmedicated

depressives experiencing these zaps," though I confess that I've carried out
no polls! Now, you mention "addiction," which is another bone of contention,
isn't it? The official line (ie, the recent Committee on the Safety of Medicines
Expert Working Group report11), is that no SSRI is addictive, but that they do
give rise to withdrawal, which is a symptom of addiction, within certain
preferred definitions (eg DSM-IV12), but not addiction, itself. What's your take
on that, and does it really matter what one calls the experience?

Well I can only go by personal experience. I smoke cigarettes and crave one
if I go for long periods without one. I actually quit some years ago for the
best part of a year, I didn't get side effects apart from the first few weeks of
wanting one - more of a habit than an addiction. Yet, the government
recognises smoking as an addiction. When my Seroxat tablets were running
out I used to collect my prescription and head off to the chemist over the
road from the surgery. On one occasion they told me that they were out of
Seroxat and could I come back tomorrow? I broke out into a sweat as I knew
that I would not be able to get through the night without my 'fix'. I refused
to leave the chemists and they sent an employee to another shop down the
street to get me 40mg of Seroxat just to help get me through the day. After
that experience I used to dread walking into a chemist only to be told that
they were 'out of Seroxat'. I can say with hand on heart that if any chemist
had ever refused to help me I would have willingly ripped the shop apart
until they could give me what I wanted. That Matt, is an addiction problem.

GSK knows there is a problem with Seroxat as does the MHRA, I am

convinced of this. To admit that there is an addiction problem now would
show up the regulator’s past incompetence. I would be prepared to overlook
and I would even shake the hand of the MHRA CEO and thank him for
acknowledging what I and others have been saying for years. The semantics
used by GSK is purely spin, nothing more, nothing less. What's even more
confusing is Alistair Benbow's13 claim on BBC TV's Panorama -:

"Whilst acknowledging that patients will get symp… or may get symptoms on
stopping Seroxat, although we still don’t think – and I'm absolutely certain
that Seroxat is not addictive – that language was clearly misunderstood and
therefore we have proposed that we will take out that specific wording."14

I know it is addictive because I was hooked on it. I guess we will never

know unless Grassley gets his way in the United States.

Q: LOL. My Legal Method and Legal Systems professor, Lindsay Farmer, once
advised my seminar group that when a judge gets a dictionary out, in order

11
See The Report of the CSM Expert Working Group on the Safety of Selective Serotonin Reuptake
Inhibitor Antidepressants, published in 2003
(http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con019472.pdf).
12
The Diagnostic and Statistical Manual, currently in its fourth edition, published by the American
Psychiatric Association, “is the standard classification of mental disorders used by mental health
professionals in the United States.”
13
Dr Alistair Benbow is Head of European Clinical Psychiatry, at GSK. He has featured regularly as
a spokesperson, in defence of Seroxat.
14
BBC Panorama, "Taken on Trust," 21 September, 2004
http://news.bbc.co.uk/nol/shared/spl/hi/programmes/panorama/transcripts/takenontrust.txt
to interpret a statute, then one ought to be prepared for a piece of bad law
to be made! I seem to remember that the EWG report was a very dry read, on
the question of addiction! I think it was claimed that patients weren't subject
to the necessary craving/seeking of the drug, amongst other things, to
qualify it as addictive. You mention Benbow, there - he excites a considerable
amount of invective - you were threatened by GSK's lawyers15, earlier in the
year, concerning a video that was intended to demonstrate the
inconsistencies in his public claims, weren't you? Did anything ever come of
that?

Well as you know Matt I publicly apologised for my comment about Benbow
and also removed the video from Youtube. I had apparently caused him a
great deal of distress with not only the comment, but the video, too. The
irony of it was that the video was, in essence, a slide show of comments
made by Benbow juxtaposed with news stories. Glaxo's lawyers didn't like
me using the GSK logo or pictures of Benbow that were apparently the
property of GSK. I never heard whether Benbow accepted my apology. I did
find it strange that GSK targeted me yet when the video was re-uploaded to
Youtube by someone else they didn't really seem to have a problem with it?
The support I got from advocates was quite overwhelming. It was a show of
strength and if anything put Seroxat Sufferers on the map. The actual video
in question has now been posted on blogs and has received more coverage
than it ever would have by remaining on Youtube. My blog was created to
raise awareness, occasionally I will sound off. On this occasion GSK lawyers
actually directed visitors to my blog. I think they rarely get involved in
personal opinions because they know that it will direct traffic to the
awareness being raised. They almost definitely made an error of judgment in
this instance. Proof that lawyers don't always make the right call... even
highly paid ones such as GSK's.

Q: Well, lawyers, like most, I suppose, act according to instructions, and

because they're getting paid to act. We'll probably never know what those
instructions were, but the warning letter you received was probably their
best effort at carrying out those instructions. I wanted to talk a bit more
about the side effect profile of Seroxat - the suicidality issue, specifically.
Again, the official line, whilst acknowledging that it is a problem, minimizes
the risk. How do you see that?

It is difficult to prove that Seroxat causes suicide because of the underlying

circumstances in most of the cases. Again the suicidal thoughts issue could
be down to the reasons why the patient is actually on the medication... at
least that's the route GSK lawyers would take I guess?

It's a strange route to take wouldn't you say?

I mean, by their own admission, GSK admitted that it could cause suicidal
thoughts in children - I say 'admission' when in actual fact they were backed
into a corner in admitting this fact.

So, if they admit it causes suicidal thoughts in children could it be feasible

15
See, for example, Pharmalot’s Glaxo, an Angry Blogger and Free Speech
(http://www.pharmalot.com/2008/04/glaxo-an-angry-blogger-and-free-speech/)
that it can cause suicidal thoughts in adults?

Here's Alasdair Breckenridge’s, Chairman of the MHRA, take on things:

“There is very good clinical trial evidence that these drugs do not cause
suicide, they do not cause suicidal thoughts in adults.”16

And Benbow:

"The evidence, however, is clear, these medicines are not linked with suicide,
these medicines are not linked with an increased rate of self harm."17

Given what we know now, Matt, in fact what we [Advocates] have known for
some considerable time, I lean toward the school of thought that suggests
Seroxat does cause suicide or suicidal thoughts in adults. Donald Schell
murdered his wife, daughter, and granddaughter in a fit of rage shortly after
starting Paxil. He then took his own life by blowing his brains out with the
murder weapon. The remaining members of the family won a multi-million
dollar settlement from the GlaxoSmithKline18. The phrase 'Enough said'
springs to mind.

Q: Suicidality, as a side effect, is now acknowledged on the PIL, but officially

at least, it is only the under-30s who are at risk (or the under-25s, if one
lives in the Antipodes, I think). The case you mention, Tobin v Smithkline
Beecham, was a civil case, of course, and SKB (and subsequently, GSK),
continued to maintain that the drug was safe in over-30s, presumably
because the standard of burden of proof [“on the balance of probabilities“] is
much lower in civil cases [than the criminal standard of “beyond reasonable
doubt“]. The EWG came to the same conclusion, in its report: the older
demographic is safe, and relevant government sources have followed this
line. Aside from successful civil actions (of which Tobin was just the first),
what leads you to think that GSK, the MHRA and the UK government are
mistaken?

Because of the evidence Matt - See the recent Glenmullen report19. Because of
GSK's reluctance to come forward with the suicide data in the paediatric
studies - it took them years. Because of the 'experts' they hired to basically
pimp Seroxat - Martin Keller20 et al. Because of the online Paxil petition and
patient comments21.

16
Ibid.
17
Ibid.
18
Tobin v Smithkline Beecham Pharmaceuticals 164 F. Supp.2d 1278 (D. Wyo. 2001) . See also
Paul Whitehead, MD, Causality and Collateral Estoppel: Process and Content of Recent
SSRILitigation, J Am Acad Psychiatry Law, 31:377-92, 2003
19
http://finance.senate.gov/press/Gpress/2008/prg061208a.pdf
20
Dr. Martin Keller is the Mary E. Zucker Professor and Chairman of the Department of Psychiatry
and Human Behavior at Brown Medical School in Providence, RI, as well as Executive
Psychiatrist-in-Chief at the seven Brown Medical School affiliated hospitals. He is alleged to have put
his name to an academic article, published in the Journal of the American Academy of Child and
Adolescent Psychiatry, which he did not write, and had not seen the data supporting the conclusions
drawn to the effect that Seroxat was efficacious and safe in the treatment of minors.
21
http://www.fileden.com/files/2008/5/6/1899375/WITHDRAW.pdf
I don't think GSK, the MHRA and the UK government are mistaken, I think
they are aware but such an admittance would have drastic consequences for
all those concerned... or not as the case may be.

I have used this analogy before Matt. If Heinz Baked Beans sold their wares
and it was proven that one of the ingredients caused children to commit
suicide or have suicidal thoughts, do you honestly think that they would
remain on sale? OK, baked beans don't profess to cure an illness like Seroxat
does but the fact remains - if the make-up of the beans was detrimental to
one age group then common sense would be to pull the product. I cannot
think of any other product on the market today that is being sold to
members of the public where it has been proven to cause serious danger in
children, unless of course alcohol and cigarettes are thrown into the pot.
Thing is we all know the dangers of alcohol and cigarettes, what we don't
know are the dangers of Seroxat. Step forward the risk-benefit ratio - the
figures just don't add up.

Q: There's countermanding evidence, then, and from expert sources? That

could, of course, simply be an alternative reading of the available facts. You
touched on the issue of "efficacy," there - it is argued that the drug is
sufficiently beneficial to justify its continued availability, notwithstanding the
side effects, now acknowledged to an extent, of course. Given that you
questioned the "benefit," in an earlier answer, do you regard the drug as not
being sufficiently efficacious to justify these risks?

From my own personal experience, Yes. A total of 21 months to taper off it

was not beneficial to me. Taking Seroxat... or rather withdrawing from
Seroxat took away almost 2 years of my life. I would say that taking away
someone’s right to live as they want isn't beneficial to anyone.

Seroxat can help people through depression, I don't think I or other

campaigners have an issue with that. Our issue is that it is so difficult to get
off of and when trying one is faced with a whole host of adverse reactions.
For me, these reactions far outweigh the 'benefits' of taking Seroxat. Like
you, Matt, I still do not know what the benefits are of taking Seroxat. I do
know that whatever they are, they do not outweigh the risks as GSK and the
MHRA would have us believe.

Way I see it, the only possible answer GSK or the MHRA could give regarding
the 'benefits' of Seroxat would be 'because it helps people with depression'.
Put that up against the list of adverse reactions on the patient information
leaflet and/or the 'anecdotal reports' then we have a serious imbalance in
benefits and costs.

Q: But there's an objective assessment of efficacy, isn't there? There must be,
or else the MHRA wouldn't be able to carry out a risk:benefit analysis. I know
that NICE22 has decided that a drug must alleviate the symptoms of
depression better than placebo - three points better, on Hamilton DRS, than
placebo. Is NICE's measurement of efficacy different to the MHRA's, and if it's
22
The UK’s National Institute for health and Clinical Excellence, or NICE, is responsible for drafting
guidance to GPs, concerning best practice in the treatment of medical conditions. It is also responsible
for approving drugs for use on the National Health Service.
the same, is three Hamilton points an acceptable trade-off against the
withdrawal effects and suicidality that we've discussed?

It's hard to judge, Matt. The MHRA will receive the yellow card reports citing
adverse reactions to Seroxat, they will log them and... well, that's basically it!
They have nothing to put them up against. I think where they fail is that they
assume all the others taking Seroxat who haven't made a complaint or filled
in a yellow card must be happy with Seroxat. That's the way I see it, anyhow.
I really can't see any other logical explanation for their reluctance to
condemn Seroxat. They grant a licence to a drug, they get complaints - I,
myself, am not asking for Seroxat to be removed from the shelves, I am
asking for the whole withdrawal issue to be acknowledged and for the MHRA
to stand with the patients on this and not the manufacturer. I can't really get
into the Hamilton points thing as it is something that I have not really
studied and I wouldn't feel comfortable talking about it.

To sum it up.
BENEFITS = 1
RISKS = Loads.

Now, I'm no Einstein but I'm guessing that the figures don't add up!

Q: Withdrawal is acknowledged as an issue, to an extent (ie, it's on the PIL,

and the EWG accepted it was a factor in the use of all SSRIs). What are you
hoping for, from the MHRA, over and above what it's already doing?

Well, to act, Matt. The MHRA seems to be doing a lot of listening but nothing
more.

I've publicly stated what I want from them.

There is currently no guidance on withdrawal other than what it states on the

patient information leaflet. I would want the MHRA to liaise with someone
like David Healy so they could at least offer some sort of withdrawal
programme for those suffering severe withdrawal. This programme would
have to be available at surgeries and NOT just as a download on the MHRA
website.

I would want them to send a 'Dear Doctor' letter out to health centres in the
UK stating that any patient suffering from withdrawal with Seroxat MUST be
prescribed the liquid suspension and given a programme of withdrawal [see
above]

I would want special clinics set up for those suffering withdrawal... even a 24
hour hotline specifically set up to talk to patients going through the
withdrawal process. A patient can feel suicidal when withdrawing too fast,
they may have the choice of ringing the Samaritans but would a volunteer at
the Samaritans actually know what it feels like to be 'coming down' from
Seroxat?

The MHRA needs to liaise with the government on this. If Pharma want to
fund it then so be it, but they cannot have any influence on those handing
out the guidance. Who better to operate these guidelines than former
withdrawal sufferers?

Maybe a special warning needs to be included on packs of Seroxat, such as

there is with packets of cigarettes. Not every patient reads the PIL but I do
think patients would take notice if a warning was slapped on the box.

They [MHRA] may think it's an awful lot to ask for, I would have to disagree.
They are in a position to stop un-needed suffering, they have an opportunity
to show how much they care about safeguarding human health.

They ARE listening... I'll give them that and the communication HAS
improved but it's time for action, it's time for them to prove to the patient
that they are not in Pharma's pocket.

Q: Well, aside from the question of funding, none of the things that you
mention appears outlandish, and, perhaps more importantly, none requires
that GSK/other takes the blame for what has gone before, nor even
acknowledges that a wrong, in the shape of knowledge of what was
happening, has taken place. Aside from any adjustments to the PIL, which
would obviously require agreement from GSK and the MHRA, have you
considered de-looping the authorities, and setting up your own helpline,
perhaps in conjunction with Seroxat User Group - in that way, you wouldn't
be beholden to anybody?

I would bend over backwards to help people suffering withdrawal Matt. One
phone line just wouldn't be enough and then of course there is the money
required to set up such a thing. I would help run such a service but it would
be logistically impossible to man a phoneline as I have a life too. If anyone
wishes to start such a 'helpline' up then I would be willing to do my share of
work on it... Unfortunately, there are many people who 'bad mouth' GSK but
don't have the commitment to stand next to their convictions. I'm not
blaming them because I know how time consuming it can be and how
intimidating they or their lawyers can be. Thing is, the UK bloggers cannot
do everything... at some point someone has to step in and say 'We realise
that help is needed... what about x,y or z', will that help you?

The MHRA knows pretty much what I want and what I feel is best for all
concerned. Time will tell whether or not I get it.

 2008 Fiddaman, Hart, Hart and Holford