The hell of Aropax withdrawal

Following on from Part I [Like a Lamb to the Slaughter] of Mark's trilogy of guest posts.

This post sees Mark describe the frustrations and hardships of withdrawing from GlaxoSmithKline's Aropax, known in the UK as Seroxat and in the US and Canada as Paxil.







Life at Paroxetine Island(PI) can only really  be described in hindsight and with insight once one has spent time back on the mainland and drug-free. Here are some observations:

• On arrival at PI one has all motivation, passion, spontaneity and confidence taken away and one is given yawning, fatigue and indecisiveness 24/7 in exchange.
• On my 1st night at PI I experienced the most real, horrific and terrifying dream of my life. It involved my death. At the time I was clueless as to what caused this.
• Like creeping mold is to the internal walls of a house in winter so too was paroxetine to my brain. It was a slow, insidious takeover of not just my brain but also my soul. Dulling my emotions and senses, and even when the wallpaper started falling off I was clueless as to the cause.
• My quality of life grew worse and worse, as I became more and more removed from reality.
• Life was sucked out of me and I was no longer living I was simply existing.
• I became a loner and yet I wasn't lonely.
• Much time and effort was spent fighting back evil intrusive thoughts, thoughts that did not belong to me, thoughts that were extraordinarily immoral, offensive and almost audible in my mind beckoning me towards self-destructive behaviour. Thoughts that were demonic in nature.
• Personality and behavioural changes occur on PI perhaps best described as a severing of the conscience.
• Loss of feelings and caring occurred, a total disconnect from reality. The mantra of PI was:
•  ‘So what, who cares’! And I was soon singing it.
• An early attempt to break free and swim to the mainland resulted in such psychological, emotional horror and panic I rushed back to my doctor and asked to go back to PI. I was sent back no questions asked. 
• Despite promising to never swim away again several more failed attempts to escape left me in a state of learned helplessness, a massive major paradigm shift now occurred in my being. I now believed that I needed to be on Paroxetine Island!
• One day I learned of a person who had escaped from PI and swum back to the mainland. I became very envious, jealous even!
• I was now determined that I too would get back to the mainland. Little did I know that I was about to start a 3-year traumatizing nightmare, a journey through ‘Hell,’ that was going to require every ounce of strength to survive, fighting for my life, daily. 

I would like to start by just saying that my escape from PI was the most difficult thing I've ever done in my life. No non-poisoned-by-an-SSRI-brain can conceive, imagine, or understand the traumatising nature of this ordeal.

• I presented to my doctor in January 10, after 10 years use, wanting to get off paroxetine. His reply “okay come off slowly”, and sent me on my way. (Absolutely criminal!)
• I had no idea what slowly was. But decided to start to alternate doses 20 mg one day and 10 mg the next.
• After 6 months I was on 10 mg and in a distraught state.
• The distress drove me to seek counselling, yet it offered no relief. Except lighten my wallet.
• At 9 months and on 5 mg feeling death would be a welcome relief I reluctantly presented to my Doctor (Dr W), only to be told I had an underlying depression and I needed to up dose. At this point I realised Dr W was clueless. I replied, ‘that is not right’. He referred me to a psychiatrist Dr S.B.
• Confused, distraught, frustrated, and in a very dark place, somehow knowing deep down something was not right here but what could it be, I confided in the neighbouring pharmacist. He leaned over and quietly whispered, “Mark I’m not supposed to tell you this but it’s not you it’s the drug”.
• It was like a light switch was flicked, the light bulb went on, I came to my senses. Of course it’s not me, it’s the drug! It was the damn drug! How could I have been so stupid! Words cannot describe the humiliation that started to flood my being followed by anger and disbelief.
• I immediately started digging, and stumbled upon an SSRI addict’s and survivors support group. I realised I had found a place ‘sought by millions but found by few’. I owe my life to them.
• On asking the psychiatrist Dr S.B. if he was aware of any problems with people getting off Paroxetine  he replied, “Well if there were problems with people getting off paroxetine people would be suing the drug companies” [I was later to realize this was a Dr who clearly had his initials around the wrong way].
• He also okay’d a Healtheries supplement I wanted to take to try to get some relief. I was sent on my way. I now realised I was on my own.
• I broke free of PI on 28 September 2010.
• The 9 month taper down and the next 2 years drug free was hell. The nightmare I had to suffer (believe me to call it a nightmare is an understatement) coming off this drug had nothing to do with me and everything to do with this drug!
• I wouldn't want my worst enemy to go through this. I was unable to function experiencing daily uncontrollable restless anxiety, endless crying and drug induced suicidal ideations starting from 6 a.m. lasting throughout the day and receding somewhat in the evening. I felt as if I was being psychologically and emotionally raped daily. This withdrawal horror went on for almost 3 years, with the drug induced withdrawal hell pushing me for months to cut my wrists, then for months it tried to get me to hang myself, then it wanted me to shoot myself, and if that wasn't enough drive my car into oncoming traffic. I still remember the day I fought off an overwhelming desire to jump off a bridge.
• These drugs are not given to patients under 18 because they cause suicide …well if my experience is anything to go by they should extend the relabeling ban to those under 50!
• In order to get through this hell alive I dragged several family members so far into emotional overdraft I will never be able to repay them. You can forget being able to hold down a job during this ordeal it’s a battle to just survive each day.
• I so much wanted to reinstate to take the horror away, yet I was driven by a sense of unbelievable anger and humiliation to not do so. Often chanting back ‘it’s not me it’s the drug’ when waves of hell flooded me.
• All I wanted was an opinion on my sore arm, I never consented to this.
• At about 18 months drug free I felt the shark infested waters start to recede, a few months later I washed ashore onto the mainland, exhausted, traumatized and in total disbelief that I was still alive.
• I felt like Rip Van Winkle coming to after being placed in a living coma becoming acutely aware of the damage done to me, waking up in shock and disbelief.
• Let there be no mistake about it, if I was an enemy combatant and the NZ army did this to me, someone would have been dragged to the Hague and jailed for this! 
• Hippocratic Oath…..Yeah Right!
• I was determined to get an explanation for this insult to my humanity an answer for something no human should have to endure.

Bob Fiddaman

Roche NZ, lengthy response to consumer query

So, you feel suicidal, maybe you've self-harmed, maybe your child has been born with a heart defect or brain abnormality - you could be a parent who has lost a child to suicide or a wife/husband who is mourning the loss of a partner.

If you fall into any of the above categories and antidepressants have been involved, chances are you'll accept that Joe killed himself because he was depressed or Lucy self-harmed because she has a psychiatric disorder and that's what people do when they are mentally ill. Maybe it was just God's will that young Daniel was born with a serious heart defect or Kate was born with defects to her skull... then again, maybe not.

I recently emailed 6 of the major pharmaceutical companies and asked about the protocol in place to respond to consumers who report an adverse reaction to them. Only two of the six replied. I'm grateful to Roche and Merck for their feedback.





I'll focus on the response that I got from Roche as it was refreshingly long and not just some cut and paste job from a compliance manual.

I asked two questions:

1. What are your obligations if you receive an adverse event from a consumer?

and

2. Are you obliged to give feedback to the reporting consumer?

I was more interested in answers to question 2 as this seems to be a grey area for many. More often than not  pharmaceutical companies tend not to write what they can say and don't say what they can whisper.

Managing Director at Roche Products (NZ) Limited, Stuart Knight, was very helpful.

Dear Mr Fiddaman

Thank you for your enquiry which has been passed onto us at Roche New Zealand. And I am assuming your question relates to medicines, rather than medical devices. 

1. What are our obligations if we receive an adverse event from a consumer?

The ongoing monitoring and reporting of adverse events is a priority for all pharmaceutical companies & government medicine regulators. It is actively encouraged and it helps build over time, a stronger evidence for any medicine, thereby helping to ensure its safe and appropriate use by both prescribers and consumers. 

As with all companies, Roche have to follow applicable global regulations such as European Union Pharmacovigilance legislation and ICH Good Clinical Practice (GCP) guidelines, which dictate what our legal responsibilities are. Individual countries also follow their local regulations if stricter than global requirements. 

All adverse events Roche receives (regardless of who has reported them), get entered into our global Safety database (and therefore contribute to signal detection), also ensuring we comply with data privacy requirements. Roche then submit reports to individual country Regulatory Authorities (who are independent Government agencies tasked with ensuring medicine quality, safety and efficacy), who then generate local safety overview documents (datasheets and consumer medical information leaflets) to assist prescribers and consumers. 

In NZ, we report adverse events for 'approved' marketed medicines to the Centre for Adverse Reactions Monitoring (CARM), if the case meets CARM’s reporting requirements. 

The requirements can be found on the Medsafe website http://www.medsafe.govt.nz/regulatory/pharmacovigilance.asp 

Essentially, any report has to be rated/graded and assessed according to ICH seriousness assessment guidelines. Further information on this is available on the Medsafe website. 

2. Are Roche obliged to give feedback to the reporting consumer. 

I wasn't sure what you meant here, so have tried to answer it broadly. If it doesn't meet your needs then please let me know. 

If a consumer or patient has a question relating to a possible adverse event, then they can phone or contact our Roche NZ Medical Information service and the enquiry will be answered. However we do often need to involve the consumers Healthcare Professional - HCP (e.g. their doctor/prescriber). We need to do this because we are not aware of the wider medical context and therefore it is sometimes difficult to answer questions without having further information. Permission to provide information to the patients/consumers HCP will always be requested. 

If a consumer reports an adverse event to us, in order to fufill our legal obligations we will need to get medical confirmation of the event from their HCP. In order to do this we request written consent from the patient to contact their HCP. If we do not receive written consent, we do not contact their HCP. 

Regarding the adverse event itself, once it has been reported to us, further contact with the reporter (irrespective of who it is) is not made. But consumers and HCPs can read summary documents of reported adverse events of the medicine(s) on the Medsafe website. 

If you have any further questions then please do not hesitate to contact me. 

Yours sincerely 

Stuart Knight

Quite a response from a major pharmaceutical company I'm sure you'll agree.

I was, however, quite baffled with Mr Knight's response to question 2 - "Are Roche obliged to give feedback to the reporting consumer."

Mr Knight's answer didn't really make much sense to me and, it seemed, to make a mockery out of the current legislation here in New Zealand. With this in mind I wrote back the following...

Many thanks for this response.

On answer two you gave me I'm slightly confused as this would, as far as I know, contravene s22(f) of the Health Act 1956 and rule 6 of the New Zealand’s Health Privacy Code 1994 which you will be aware covers health information held by pharmaceutical companies. 

Can you clarify this for me please?

Bob

I didn't have to wait long for a reply...

Dear Bob,

Thank you for your follow-up email question.

In my email to you on Friday 26 April  I said:

“Regarding the adverse event itself, once it has been reported to us, further contact with the reporter (irrespective of who it is) is not made. But consumers and HCPs can read summary documents of reported adverse events of the medicine(s) on the Medsafe website.“

Your email expresses the view that:

“This would, as far as I know, contravene s22(f) of the Health Act 1956 and rule 6 of the New Zealand’s Health Privacy Code 1994 which you will be aware covers health information held by pharmaceutical companies.”

It looks like you might have taken a meaning from my email that was not intended.  Roche is fully aware of its obligations under the Health Act and the Health Information Privacy Code and Roche’s policy and practise is to comply with those obligations.

What I was intending to convey is that as a general matter of policy, Roche will not initiate follow up contact with people that have reported an adverse event.  Those people are still free to make contact with Roche and Roche will respond as appropriate.  If an inquiry concerns a person’s own personal health information  then Roche will:

• provide that person with confirmation as to whether or not Roche holds the Information, if the Information can be readily retrieved (subrule 6(1)(a) of the HIPC);

• provide that person with access to the Information, if the Information can be readily retrieved (subrule 6(1)(b) of the HIPC); and

• provide that person with the right to correct the Information (subrule 6(2) of the HIPC),

unless Roche has appropriate lawful justification for refusing to disclose or provide access to the Information. 

If, for example, we withhold Information for reasons in sections 27 to 29 of the Privacy Act 1993, we will inform that person of:

• the reason for the refusal;

• the supporting grounds; and

that person’s right to make a complaint to the Privacy Commissioner and to seek an investigation and review of the refusal.

I hope this addresses your concerns. 

With kind regards

Stuart Knight
General Manager
Roche Products (NZ) Limited  

So, there you have it folks. You send in an adverse reaction report to a pharmaceutical company and they don't have to reply. Pursue the matter and they have to give some sort of response.

It's seems a tad silly that one would have to follow-up their own report but at least we have it in black and white now, from Roche at least.

So if you fall into the category of my opening paragraph you may just want to get in touch with the pharmaceutical company that you wish to query.

Force their hand. Don't be an anecdote.






Bob Fiddaman

Far be it from me, a blogger, to give doctors a lesson in managing antidepressant withdrawal... but I'm going to anyway.

I've been writing this blog for 8 years now and, over this period of time, have been inundated with emails from patients struggling with withdrawal issues from their medication. Most popular question is along the lines of "How long does it take before these terrible side-effects go away?"

A good 90% of the emails start off by telling me the side effects, crying, sweating, electric-like zaps in the head, shaking, most of these conditions, if not all, appear when the patient starts to taper off the drug on the advice given by their healthcare 'professional'.





When I have told those who have contacted me about their medication being available in a liquid form they are flabbergasted. Why didn't my doctor tell me this? is the normal reply.

The liquid formulation for SSRi type medication came about as a result of pharmaceutical companies being able to persuade doctors [via their reps] that patients who had difficulty in swallowing their medication could always use the liquid. These 'patients' were the elderly and children. The liquid was never intended to be used as an aid to help people wean off the medication.

Wait a minute, these medicines aren't meant for children. Correct, but that has never stopped the pharmaceutical industry reps in their quest to boost company sales in return for that big bonus at the end of each month or quarter.

So, what about adults who have no trouble swallowing tablets? Well, the gist I'm getting from the emails I've received is that doctors tend to read the company spin on withdrawal.

Pharmaceutical companies never liked the word 'withdrawal' as it implied giving the patient a hard time so they changed it to 'discontinuation'. Doctor's when reading the product monograph for any of the SSRi's will read that 'discontinuation syndrome should only occur for around two weeks'. There is no information given to the doctor or patient about how much he/she should reduce their dosage by.

Contact the manufacturer of your particular SSRi and you are taken on a frustrating journey.

Pharmaceutical companies will tell you that they are not allowed to discuss individual patient cases and will refer you back to your healthcare professional, who remember has at his disposal the product monograph that claims 'discontinuation should only last around two weeks'.

Truth of the matter is, discontinuation/withdrawal can last months even years. Your healthcare professional won't acknowledge this because all he has to go on is what the pharmaceutical company have provided him [product monograph]

Some of the advice given by doctors that I've seen personally has ranged from the ridiculous to the sublime. Here's some:

• Cut your tablet in half
• Take 20mg Monday, 10mg Tuesday, 5mg Wednesday then stop.
• Try stopping altogether at the weekend as there will be less stress in your life, ie; work, dropping the kids to school. If you still feel bad then start again on Monday.

One patient, a 17 year old, was told by his trainee psychiatrist, to stop taking his Prozac at weekends so he could enjoy up to six bottles of beer then restart again after the weekend. That patient, Toran Henry, killed himself shortly after being prescribed a generic form of Prozac [Fluox]

So, where can doctor's go for their information on antidepressant reduction?

Product Monograph [Written by the manufacturers of the drug]
Patient Information Leaflet [Written by the manufacturers of the drug]
Medicines Regulator [A body fully funded by the pharmaceutical industry]

Where do patients go?

Well, they go to the one person they can trust, their doctor. It may take a while for the patient to realise that the doctor is as clueless as they are when it comes to withdrawal help, it's then that they turn to either friends or, more commonly these days, Google.

Many patients find themselves using search terms such as 'Escitalopram aggression', 'Seroxat Brain Zaps', 'Cipramil Agitation'. The hits, when I first started this blog, were few and far between. That's when I learned that Seroxat isn't called Seroxat in the USA, it's called Paxil. Back then I Googled the words 'Paxil + Withdrawal' - I hit the jackpot. Website after website, forum after forum appeared. Stories about brain-like zaps, aggression, suicidal thinking, self-harming. The same can be said today for Cipramil and Escitalopram [both brand names for drugs known in the US as 'Celexa' and 'Lexapro' - Try a Google search yourself and you will see much more can be learned by typing in the US brand names opposed to the British/European brand names.

Even if you do find evidence that you are not alone in this withdrawal hell don't expect your healthcare professional to thank you for bringing the evidence to his/her attention. More than likely you'll be told that it was he/she who went through med school, if he/she does tell you this then ask him/her how long he spent covering SSRi withdrawal.

He/she may also tell you not to do your own research as you are either not qualified in such matters or the information on the internet about SSRi's is just conspiracy theories.

What you, as a patient, must do is TELL your doctor that you need a liquid version of your antidepressant so you can taper safely and effectively. Remember, this is YOUR body.

Tapering by using the liquid is a very slow process but it is much safer than skipping doses or drastic reductions in dosage.

You may find the taste somewhat off-putting, Glaxo's Seroxat liquid is orange flavoured and tastes like 5 cups of sugar has been added. If you can get through the bad taste then it's better than having to endure mind-bending electric jolts through your head.

Apparently the liquid formulations of SSRi's cost more, probably one of the main reasons doctors won't write scripts for them.

Remember that SSRi withdrawal is your own experience, it does not belong to your doctor or anyone else for that matter. Don't frustrate yourself because the manufacturers of your medication won't help you - that's just their way of avoiding litigation. If they acknowledge you are having a bad time on their drug then they'd have to acknowledge that other people are too - that would just open the door and they'd be flooded with personal injury lawsuits.

So, how slow do you taper once you have the liquid? As slow as you need to is the answer. I came down 0.5mg per week. [20mg dose of Seroxat = 10ml of Seroxat liquid] It took me over a year to drop from 40mg per day to 22mg per day. I then quit cold turkey - not recommended.

So, if you are a healthcare professional using Google and you have stumbled on this post then I suggest you put your BNF to one side, disregard all the pharmaceutical propaganda you have at hand, take off your God hat and start listening to patients.

The pharmaceutical industry will get richer from you, the patient, snapping up their sickly, foul-tasting liquid but at least you will be reducing the money going in their pocket. What's it to be, a slow taper or a life-time hooked on SSRi's?

At the time of writing this I'm only aware of four SSRi's that are available in liquid. Namely, Fluoxetine, Sertraline, Paroxetine and Citalopram .








Bob Fiddaman

This year's 4th annual PharmedOut conference is hitting town and, judging by the speaker list, looks like it's going to be the best yet.

Highlight of this year's conference, for me at least, is the 'surprise guest' from a major pharmaceutical company who is going to be talking about ethical conflicts inside the industry.

PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.

Some of their goals are:





Document and disseminate information about how pharmaceutical companies influence prescribing
Foster access to unbiased information about drugs
Encourage physicians to choose pharma-free CME

Sadly, the conference is too far for me to attend but I'm sure it will be much talked about in the future.

So, if you are a lawyer, state government official, FDA official, or work for the pharmaceutical industry then you may just want to go and listen to what these speakers have to say... however uncomfortable it may be for you. Speakers include:


Marcia Angell MD, author of The Truth About Drug Companies: How They Deceive Us and What to Do About It;  former editor-in-chief, NEJM
Virginia Barbour MD, chief editor, PLoS Medicine
Elizabeth Loder MD, editor, BMJ
Carl Elliott MD PhD, author of White Coat, Black Hat: Adventures on the Dark Side of Medicine and Better Than Well
Charles Ornstein, Senior Editor, ProPublica
Diana Zuckerman PhD, president of the National Research Center for Women and Families
A ghostwriter describing how he helped sell Low Testosterone Syndrome (“Low-T”)


You can register for the conference here.


Event start date: June 6, 2013 8:00 AM
Event end date: June 7, 2013 5:00 PM
Location: Georgetown University
Questions? Call: 202-687-1191

Email:  nzd2@georgetown.edu




Bob Fiddaman

18 year old Sara Carlin

Today [May 6] marks the 6 year anniversary of the death of Oakville teen, Sara Carlin.

Sara tragically took her life back in 2007 and her much publicized 2010 inquest saw her parents, Neil and Rhonda, face teams of lawyers representing doctors and GlaxoSmithKline.

Sara had, around a year or so prior to her death, been prescribed Glaxo's Paxil [paroxetine], a drug that is infamous for inducing suicide, particularly in children and adolescents.

Sara was just 18.

The inquest, that I labelled the Glaxo & Friends Vs The Carlin Family, rolled out apparent SSRi experts who made various claims that 'suicide is much more strongly related to cases of untreated depression' and in any event Paxil induced suicide is more common when first starting the drug.





Oh really?

Sara had missed her dose for three to four days leading up to her suicide. This was disregarded by the experts because "the information provided did not suggest that Ms Carlin suffered from the usual triad of symptoms seen with withdrawal" - Oh really?

Completed suicide is a symptom of withdrawal. There is no greater suffering than death Mr Expert Man!

Anyway, Sara's story went global and many, myself included, believe that her suicide was brought on by Paxil. Yes there were other factors, all of which were used by lawyers representing both Glaxo and doctors during the inquest. I've mentioned before how Glaxo like to blame everything but their product, Sara's inquest is a classic example of this.

We see this played out all the time in coroners courts. I don't envy anyone who has to sit through so called experts blaming the victim but softening the blow with terminology such as 'troubled youngster' or 'mentally ill'.

Coroners courts put the victim on trial and offer opportunity for people that didn't even know the victim to say how bad they was, be it through drinking, illegal drug-taking or being an uppity teen. We've seen victims of suicide bad mouthed before and after Sara's inquest, Toran Henry and Shane Clancy are two that spring to mind.

A whole heap of recommendations were made at the end of Sara's inquest. I have wrote about the word 'recommendation' before. It means nothing.

None of the recommendations made back in 2010 have been implemented.

Today my thoughts are with Neil and Rhonda


Here's a video I did for Sara back in 2010, a video that has been viewed over 13,000 times.

Nessun dorma Sara


Sara Carlin Inquest – Latest

Sara Carlin Inquest – Failure of Oakville Medical Profession

Sara Carlin – ‘Death by Paxil’ Inquest – The ‘Expert’

Sara Carlin Inquest – Coroner’s Witness In U-Turn… And That Man Shaffer!

Coroner’s Inquest – Glaxo & Friends Vs The Carlin Family

Sara Carlin Inquest – Local MP Slams GlaxoSmithKline

SARA CARLIN INQUEST - What The Jury Should Know

Sara Carlin Inquest - "Paxil likely played important role in teen's suicide"

Sara Carlin Inquest - The Eli Lilly 'Links' & Today's Recommendations.

**Exclusive - Sara Carlin Inquest: The Bias Of Coroner's Counsel, Michael Blain & Coroner, Bert Lauwers?

The Inquest of Sara Carlin and the Moderation of Yahoo Groups




Bob Fiddaman