The Risks Outweigh the Benefits - An Interview with Bob Fiddaman
About 2 months ago I took part in an interview with Matt Holford of
'It's Quite An Experience'.
Here is the result of that interview.
----
Robert Fiddaman(1), Gary L. Hart(2), Michelle Hart(3), Matthew Holford(4)
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 antidepressant(7), Seroxat(8). 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
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 GP(9) 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 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, 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 is 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 report(11)), 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-IV(12)), 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's(13) 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, Dr Lindsay Farmer, once
advised my seminar group that when a judge gets a dictionary out, in order 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 lawyers(15), 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
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
GlaxoSmithKline(18). 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 report(19). 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 Keller(20) et al. Because of the online Paxil petition and
patient comments(21).
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 NICE(22) 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
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.
Afterward
There is one fact that cannot be denied, by anybody: a lot of people are
experiencing suffering. This may be because of the drug, and it may not. The
cause ought to be irrelevant to a determination to seek a solution. So:
1. We have a bunch of desperate people, who are complaining;
2. It seems that everybody is expending more effort in denying responsibility
than in seeing what they might be able to do to help those people;
3. Why is that?
We already know that there is a limit to what activists can do, given our
financial resources, or lack, thereof. There is also the factor of selfishness,
if that's not too blunt a word - nobody who could help will help, because they
perceive it (or want it), to be somebody else's responsibility (ie, they don't
want to expend time, effort and money, when somebody else might be expending
time, effort and money). Finally, nobody appears to know how to begin to address
the issue, and therefore it's easier to not acknowledge it (or else blame it on
the people experiencing it), than it is to acknowledge that they don't know what
to do, when this simple thing would be the first step towards understanding. In
part, this may be to avoid acknowledging a lack of expertise in an area in which
they are supposed to be expert.
The objective as I perceive it is to have withdrawal sufferers to not feel as
desperate as they do (irrespective of how achievable one believes that goal to
be that is, nevertheless, the goal). Nothing that's being done contributes
towards that objective, as far as I can see.
Matthew Holford, LlB, FICA
(1) Bob Fiddaman is the author of
Seroxat Sufferers. 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.
(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.
(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.
(11) See
The Report of the CSM Expert Working Group on the Safety of Selective Serotonin
Reuptake Inhibitor Antidepressants, published in 2003.
(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
(15) See, for example,
Pharmalot's Glaxo, an Angry Blogger and Free Speech
(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 SSRI Litigation, J Am Acad Psychiatry Law, 31:377-92, 2003
(19) Report
of Joseph Glenmullen, August, 2007
(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)
Seroxat Withdrawal Comments
(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.
(c) 2008 Blumsohn, Fiddaman, Hart, Hart and Holford