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Tuesday, January 21, 2014

Seroxat: What Have We Learned?

A post appeared on the WZZM 13 website a few days ago that caught my attention and caused yet another deep sigh.

78 year-old Bob Farthing [Pictured] was found dead in the back of his car on Friday 17th January. Farthing was reported missing by his family on Wednesday, Jan. 15.

Details are emerging that show Farthing was having difficulty withdrawing from the antidepressant Seroxat, better known in the US by the brand name Paxil.

Farthing's daughter, Denise Shaheen, said there is only one explanation for the disappearance. "He is struggling with the withdrawal from the drug Paxil."

After using the antidepressant for 15 years, his family says doctors were weaning Farthing off of the powerful drug and putting him on other medicine. But it was a difficult process.
"He would have a couple good days, he would have a couple bad days. His bad days were very bad days," said Shaheen. "He became very depressed, very confused."

A video report of Farthing's disappearence and death is below.

Having experienced severe Seroxat withdrawal myself I really feel for this guy.

Of course, those who defend Seroxat, namely GSK and their attorneys, will argue that Farthing had been taking Seroxat for 15 years and the withdrawal he was going through was possibly his original depression returning.

Another article from M Live reports...

Witnesses told police Farthing appeared confused when he was spotted later Wednesday afternoon at Blodgett Hospital. He had asked for help with directions.
Farthing was also reportedly seen Thursday in East Grand Rapids' Gaslight Village, where he stopped in Edward Jones to ask for directions to Blodgett Hospital.
His daughter, Denise Shaheen, earlier said Farthing was recently taken off a medication and may have been confused or suffering from medical problems. He reported not feeling well on Wednesday, she said.

Cause of death is unknown and is currently under investigation.

The withdrawal issue surrounding Seroxat has been debated many times. There are a number of people who suffer mild or no withdrawal problems at all.

So, what is being done to help those  at the other end of the scale, those who suffer severe Seroxat withdrawal?

In a word, nothing!

The British drug regulator, the MHRA, have played down the issue of withdrawal time and time again, not only with Seroxat but with other SSRis too.

In fact, I personally met with the Chief Executive of the MHRA, Kent Woods, back in 2008, some 6 years ago, to discuss the withdrawal issue regarding Seroxat and other SSRi's.

Here's a summary of the minutes from that meeting.

Guidance on the Management of Withdrawal from Seroxat (Paroxetine) and Other SSRIs 

Notes of a meeting held at MHRA on 2 September 2008

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 guidance.

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 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.

Almost a year later the MHRA did meet with David Healy. Here's the notes from that meeting:

Meeting to discuss awareness and management of withdrawal reactions with SSRIs and related antidepressants 26 June 2009 

1. Introductions and background 
MHRA explained that the background to this meeting was a meeting held with Mr Fiddaman in September 2008. Mr Fiddaman had raised concerns about a lack of awareness on the part of health professionals of withdrawal reactions with SSRIs and related antidepressants. Prof Healy explained that he had had a long term involvement with the safety of SSRIs and that he received a large number of e-mails directly from people withdrawing from SSRIs asking for advice on management of withdrawal symptoms. Before the meeting Prof Healy had provided documents that he had produced relating to the management of withdrawal from SSRIs. 

2. Existing advice on management of withdrawal reactions with SSRIs/SNRIs 
All agreed that most health professionals get their information from guidelines issued by the National Institute for Health and Clinical Excellence (NICE) and the British National Formulary (BNF) rather than directly from the Summaries of Product Characteristics (SPC), although it was noted that the SPC was very important as it dictated the information that would be available to the patient through the Patient Information Leaflet. MHRA informed Prof Healy that they had provided input to the recent consultation for revision of the NICE depression guideline and that the revised guideline would be available towards the end of the year. MHRA had also informed the BNF that they were looking at the area of withdrawal reactions and would contact them in the future regarding proposals for updates to the relevant sections of the BNF. MHRA also raised the important role played by Prescribing Advisors in the Primary Care Trusts in influencing prescribing practice. Prof Healy said that a key point not included in the guidance currently available was the existence of liquid formulations of SSRIs which could be useful in the management of withdrawal to allow slow tapering. Prof Healy also stated that before treatment started there should be a discussion between the prescriber and the patient about the possibility of withdrawal reactions. 

3. Awareness of withdrawal reactions in clinical community 
Prof Healy expressed the view that general practitioners (GPs) were not aware that withdrawal reactions on stopping SSRIs could be prolonged in some patients and were not aware of how to manage withdrawal reactions in these patients. Prof Healy was concerned that GPs may instinctively advise patients to withdraw by taking tablets on alternate days and this was not an appropriate approach.

4. New evidence relevant to management of withdrawal reactions 
Prof Healy was not aware of any new evidence relevant to the management of withdrawal reactions. When asked if he had a view on the size of the problem of serious and prolonged withdrawal reactions with SSRIs, Prof Healy said that this was not possible to measure. Prof Healy said that while the propensity of an SSRI to cause withdrawal reactions was often thought to be only related to the half-life of the drug, this seemed unlikely to be the case – it could also be related to the potency of the different drugs at the serotonin reuptake site. The lack of understanding of the problem contributes to a lack of effective solutions. 

MHRA asked whether in his view there was any way that patients who were more at risk of prolonged withdrawal reactions could be identified. Prof Healy said that he felt that from his experience women seemed to be more at risk than men but it was unknown whether this was because more women than men were treated with SSRIs. MHRA said that their review of the issue had not identified any link between the risk of withdrawal reactions and the gender of the patient. Prof Healy considered that there was little evidence available on how to manage patients who had difficulty withdrawing from SSRIs. All agreed that this was a very difficult area to study as the management of the patient would differ depending on the patient. 

5. Dependence/withdrawal for women of child-bearing years 
Prof Healy had asked for the issue of use of SSRIs in pregnancy to be included in the agenda. He said that it was an important issue and the subject of upcoming court cases in the USA. Prof Healy said that it was important that women of childbearing years were appropriately informed of the risk of withdrawal reactions with SSRIs before beginning treatment and stated that in his view doctors may be liable under the Congenital Disabilities Act 1976 if they did not adequately inform patients of the risks of treatment during pregnancy. 
MHRA said there had been communications about a small risk of congenital malformations associated with paroxetine and this issue was under further discussion at EU level. Prof Healy highlighted a recent publication describing an animal study looking at reproductive toxicity of a variety of SSRIs. MHRA asked for the reference and to be kept informed of any further new evidence of relevance to this issue. 
MHRA noted that NICE had published its antenatal and postnatal mental health: clinical management and service guidance and that it was important that NICE was kept informed of any new evidence or advice in this area. MHRA agreed to find out whether review of the guideline was planned and to let Prof Healy know the best contact point for communication on this issue. Post meeting note: Prof Healy confirmed post-meeting that he had contacted NICE on this issue. 

6. Opportunities for better communication with health professionals 
Prof Healy said that the focus should be on highlighting to GPs that withdrawal reactions could be serious and prolonged in some patients and agreed that NICE and the BNF would be reasonable routes.

MHRA thanked Prof Healy for attending the meeting and agreed that it would be important to keep in contact on important new evidence in this area. 

So, two meetings in the space of approx 12 months.

To my knowledge the MHRA have not kept in contact with David Healy.

I severed ties with my communications with them in 2009. I had brought the Lyam Kilker trial to their attention. Lyam was born with heart defects. His mother had taken Seroxat during her pregnancy. A jury found Seroxat to be the cause of his heart defects.

After many emails back and forth to the MHRA I decided that I was flogging a dead horse. The MHRA were just never going to acknowledge that Seroxat was a teratogen.

Here's the email I sent them.

Simon was, at the time,  Director of Communications at the MHRA.

----- Original Message -----
From: fiddaman 
To: Gregor, Simon 
Sent: Sunday, November 22, 2009 8:11 PM
Subject: MHRA - I am done!

Dear Simon Gregor, and other MHRA staff included in on this email; namely Kent Woods, Alasdair Breckenridge and Sarah Morgan.

You will note from the Cc list I have included some familiar faces, I think all but one of them will be familiar to you.

The 'give2manie' email address is an email that you have probably not come across before. It is the email address of Julie Edgington, an American. Her child, Manie, was born with transposition of the great arteries [TGA].

GA means the aorta and pulmonary arteries in the heart are switched. When a child is born with TGA there is very little oxygen in the blood. The aorta receives the oxygen-poor blood from the right ventricle, but it's carried back to the body without receiving more oxygen. The pulmonary artery receives the oxygen-rich blood from the left ventricle but carries it back to the lungs.

Manie's mother, Julie, took paroxetine whilst she was pregnant.

The reason behind this email and the reason I have included the familiar faces is because I want them all to know where I currently stand with the MHRA.

Your limp-wristed response to my question, Is Seroxat a teratogen, was really the straw that broke the camel's back. You have gone back to your old ways of fence sitting on life threatening issues.

Time and time again you are faced with evidence yet you refuse to acknowledge it. Seroxat IS a teratogen, you know it and so do I... and I imagine the others included on this email do too.

Over the past couple of years the MHRA have opened their doors to Seroxat campaigners, it was a nice gesture but I firmly believe it was merely a token one. Maybe you thought by opening your doors, the problem would simmer - Keep your friends close, and your enemies closer.

Simon, you have picked my brains over the past year or so with regard to your yellow card system, a system that is troubled, outdated and, dare I say it, about as useful as a chocolate teapot.

You are very good at what you do Simon, I bear you no malice.

Moving on to your CEO, Kent Woods. Charming man, well he was for the hour meeting I had with him. Since then he has failed to answer any of my emails. Whether he thinks I'm some ruffian from a council estate should not alter the fact that I have some serious complaints that need answering.

He has had plenty of opportunities to correspond with me but has chosen not to. The 'Kent gets hundreds of emails a day' excuse does not wash with me. Even if he did, does he ignore them all or does he just choose to answer the one's he thinks are important?

Alasdair Breckenridge is big enough to proclaim on national TV that there is nothing wrong with Seroxat, and so I gather at various dinner functions he has attended. Remind me of his role again at the MHRA?

Your recent response regarding the teratogen issue was expected. It was a classic cover your ass answer - in fact I shouldn't really use the word 'answer' as you never actually answered the question did you?

As you are well aware GlaxoSmithKline were just found guilty by a Jury in the United States. Paxil [Seroxat] was found to be the cause of the heart defects Lyam Kilker was born with. If a jury can find that Seroxat caused heart defects in a child then I have to ask myself why regulator's can't. Your Chairman being a former employee of  GlaxoSmithKline does not really help matters nor does your Head of Licensing, Ian Hudson, another former employee of Glaxo.

You are not protecting the public with regard to Seroxat and other SSRi's. Your stubborness is staggering. You choose to protect GlaxoSmithKline and anyone who sides with them, is, in my opinion woefully misguided and/or corrupt.

Seroxat IS a teratogen, I should not have to send you the evidence - you should already have it, you are a regulator after all.

I have decided to call it a day with the MHRA. There is no reason for me to correspond with you anymore. I cannot and will not have my name associated with cowards - because that's what you are. There is no direct accusation at individuals here - this is aimed at the MHRA as a whole.

You need to take a good look at yourselves and ask whether or not you are doing enough to protect the public, in particular children. Personally, I don't think you are.

For the other patient/advocates involved with the MHRA on the patient and public engagement (PPE) it is entirely up to you if you wish to continue engaging in talks with the MHRA. My decision is based on my own belief that the MHRA are simply not protecting the public and no matter how many doors they open to patients will not matter a jot because they will never take the side of the likes of myself or young Manie Edgington.

There are a further 630 cases to be heard in the USA regarding children being born with heart defects. The Kilker trial was a landmark case and has set a precedent, the others, I assume, will be settled out of court. No liability. No public record that Seroxat is a teratogen.

Which, will suit the regulators just fine.

I do not want a detailed explanation of the reasons why you could not answer a simple question. My main concern is doctor's in the UK are still prescribing a teratogen - because the MHRA are too limp-wristed to condemn it.

Yours sincerely,

Bob Fiddaman

Author of Seroxat Sufferers


Approx two years later the MHRA announced that they were rolling out an SSRI Learning Module for healthcare professionals. It would be nice to think that the meetings with myself and David Healy had some influence on this project but the more I looked into it, the more dumbfounded I became.

On the subject of severe SSRi withdrawal the MHRA were telling healthcare practitioners to recommend "specialists" to patients.

With this in mind I sent the following to the MHRA:

Can the MHRA provide me with a list of specialists experienced in SSRi withdrawal that are a; in the UK and b; available on the NHS.?

They couldn't provide me with any such list of 'specialists.

I wrote a series of articles on the SSRi Learning Module, all of which can be found at the foot of this post.

It's not just the MHRA that should come under fire.

On May 6, 2007, Neil Carlin found his 18-year-old daughter, Sara, hanging from an electrical cord in the basement of the family’s Oakville, Ontario. A bottle of  Seroxat, which her family doctor had prescribed to her 14 months earlier, was found at the scene.

The inquest into Sara's death was high profile and was covered extensively by the Canadian media. I covered the inquest myself, reporting what the media failed to report through fear of lawsuits from GlaxoSmithKline.

After a gruelling 10 day inquest a jury issued 16 recommendations on June 28, 2010.

It fell short of blaming Seroxat on Sara's death.

To date not one of the 16 recommendations have been implemented.

“We realized it’s a bullsh–t process,” Neil Carlin said. “They go through the motions to give the public a sense of confidence they’re on top of it. Nobody really cares or follows up.”

The inquest that the Carlins had pushed for became, in their eyes, nothing more than “window-dressing.”

“It’s sort of a hollow victory,” Carlin said. [1]

I've met Sara's parents. Spent some time with them in Canada. They remain firm friends.

So, with all of the above, exactly what is it we have learned? well, as consumers we pretty much know how dangerous Seroxat is. Those that regulate drugs like Seroxat have failed and continue to fail. Coroner's who carry out inquests into suicide, in the main, fail to make any connection between suicides and SSRi's. If they opened their eyes they could be doing the public a great service. Alas, they are blinkered and convinced that drugs do not cause a person to kill's the illness.

SSRi induced suicides, SSRi causing severe withdrawal, SSRi causing birth defects.

Hey, what's a few deaths here and there.

Chief Executive of the MHRA, Kent Woods, retired last year. His position was filled by Ian Hudson.

I'll leave you with an email I sent to Hudson on Nov 8 2013. He never replied.

Dear Mr Hudson,
As I understand you are now Chief Executive of the MHRA. I'd congratulate you but we both know that I'd be lying with those congratulations given your past links to GlaxoSmithKline and Seroxat.
That aside, I have to remain professional.
My question to you is one of great concern and one that I shall be making public on my blog
Are you, or do the MHRA plan to reevaluate the current recommendations that pediatrics should not be prescribed SSRi's?
I ask as it has come to light that MHRA consultant, Stephen J W Evans, has recently co-authored a study where he and the other authors call for a re-evaluation of the current prescription of SSRIs in young people - Back story here.
This email, along with your answer, if you are brave enough to answer that is, will be published on my blog.
Best wishes

Bob Fiddaman

MHRA's SSRI Learning Module