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Dr June Raine, Director
Post-Licensing Division
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

4 August 2002

       Dear Dr Raine,

ADROIT guidance on interpretation of Yellow Card Data

I have just read the comments in Pharmaceutical Journal (PJ, 2 August 2002, 269, 7209, 149) by an un-named MCA spokesman, taking me to task for failing to include, with our virtual Dear Doctor letter, a copy of the CSM/MCA guidance notes on the interpretation of Yellow Card data.

1. I have now hyperlinked the Guidance on Interpretation to the Dear Doctor letter, and to the Table itself. I did so with a heavy heart because it’s a pretty miserable document - un-readably long, badly organised, hopelessly presented and deeply uncommunicative. It seems to me that the Guidance is barely relevant to the data we posted – but if it was so important, why didn’t someone from the MCA get in touch and ask me to post it? I assume that the MCA’s allegation of some failure on our part was mainly to bamboozle the PJ.

2. In the first of the two quoted statements, the MCA spokesman said: "The reporting of a reaction does not necessarily mean that the drug caused the problem and therefore these reactions should not be used as a list of side effects for the medicine to which it refers." Leaving aside the implication that the data you provided may be entirely meaningless, this again seemed to me a ploy to distract from what is overwhelmingly the point: that paroxetine is in a league of own and that the problems associated with its use are grossly under-recognised and under-reported. Is it honest to lead the press to believe that the reports sent to the CSM/MCA may over-estimate the problem, when gross under-reporting is the far greater problem?

3. I am sick of reading comments from SSRI/SRNI users that speak of the inadequacy of their doctors – though of course they are victims too. I have attached a tiny sample of users’ comments, indicative of the great distress that misinformed doctors seem to be causing. Please will you circulate these, plus this letter, to the CSM? The comments on our website reveal important reasons for ADR under-reporting – and underline the huge gulf between clinical medicine as it is, and as idealised in regulatory assessment.

4. Please would you let me know the name and position of the person representing the MCA’s views who was quoted in PJ, also the name(s) and position(s) of any person(s) who briefed them? Please will you also let me know if PJ was provided with any written briefing and, if so, please may I have a copy of any document(s) sent?

5. Since the CSM/MCA guidance notes are entirely ill-suited to communicating with the lay public about the interpretation of the Table attached to your letter of 3 July, please would you explain ("cogency, brevity and clarity" etc.) for the benefit of the general public the MCA’s interpretation of what those data mean? Do they mean anything at all? If so, what?

6. Do the CSM/MCA now reject the interpretation in the 1996 paper by Price and his CSM/MCA colleagues, that, "overall, symptoms due to stopping SSRIs are rare" and that SSRI withdrawal symptoms "do not appear to be severe", but are "are relatively mild and do not have features of a physical drug dependency syndrome"? If the CSM/MCA no longer stands by this assessment, what lessons have been learned about the interpretation of ADR reports, and what plans do the CSM/MCA have to set the public record straight, by qualifying the statements made? The Price paper is still widely quoted in promotional and other literature: is this what the MCA wants?

7. I should like to verify the major claim in the Guidance notes, that "it has been estimated from various surveys that only 10-15% of serious ADRs are reported." Please will you provide me with copies of or citations to the "various surveys" relied on? Do the CSM/MCA accept that the reporting of ADRs which occur on withdrawal of therapy is probably much less than for acute reactions?

8. What is the CSM/MCA’s best estimate of the level of under-reporting of withdrawal reactions to antidepressants, including SSRIs? I ask this because I also get sick of reading – in spite of overwhelming evidence to the contrary - that doctors have known all along about antidepressant withdrawal reactions. In fact, it took 30 years just to get a warning in the British National Formulary. In the late 1980’s, the head of the ADR operation at what was still Ciba-Geigy called to ask if I’d ever heard of such a phenomenon – and the regulators wouldn’t have collected more than a few dozen Yellow Cards at the time. The level of self-deception seems surreal.

9. The second quote attributed to the MCA in the PJ report said, "Numerical comparisons should not be made between reactions associated with different drugs on the basis of this information" (i.e. the Table you provided to us). "Comparisons can be misleading unless they take account of wide a number of factors." Do the CSM/MCA think people would be mistaken to infer from the Table that something has gone badly wrong, if five of the top six drugs on this list are SSRIs, with paroxetine ahead by far?

Please treat all of the above questions as formal requests under the Code of Practice on Access to Government Information.

Yours sincerely,
Charles Medawar

CLICK HERE TO READ ON

SSRI users’ experiences with doctors

"Eleni" – 29 July 2002 "What worries me the most, having seen this site is the complete lack of guidance and input offered to me by the doctor who initially suggested I start using Cipramil. I was not told of any of the potential side-effects or withdrawal symptoms, however unlikely, and was in fact told that there wouldn't be any. I was never contacted by the doctor, to check my progress over the year, and I took the initiative to lower the dosage. Has anyone else felt like they were misinformed and left to work things out for themselves?"
"Karen" - 28 July 2002
"I think all GP's should know more about these drugs and not be so quick to dismiss their patients opinions and experiences."
Graham – 25 July 2002
"I've just been prescribed Paroxetine by my Doc as I had a panic attack on the way to work on Monday and have been suffering anxiety on and off for months. He has prescribed 10Mg a day (half a tablet). He assured me they were not habit forming and had few side affects. This doesn't seem to be the case from what I've read here today."
"Chris" – 4 July 2002
"I asked my doctor several times if there were withdrawal problems as I noticed feeling "funny" if I missed a pill or two. She denied it and told me I should be able to come off them in a week or so. Now I've been working at it for six."
"Eric" - 28 June 2002
"I went to my GP in Dover yesterday and was absolutely gob-smacked by his attitude. Basically he said he hasn't heard of any problems concerning withdrawal from Seroxat. I mentioned the articles in newspapers recently and websites awash with people who have been abandoned by the medical profession in a limbo and he replied " well, I don't read the papers or visit the websites. You can't believe everything you read." The sum total of his 'helpful' advice was to go back on to Seroxat. It seems there's too much money washing around from the manufacturers and GPs are more keen to keep their patients on this drug then help and encourage them to do without medication."
Jeannette Clark –

15 June 2002

"Thank god I just found this site, I thought I was going mad. I tried to reduce my dose of paroxetine from 30mg to 20mg about 6 weeks ago but when I felt weepy my GP suggested continuing with the higher dose…Am now experiencing all of the 'withdrawal' symptoms I have been reading about on this site. Should I persevere or see my GP again who is likely to imply that symptoms are psychological?…I don’t really want to revisit my GP as she does not really believe that these symptoms are 'real' and not just a continuation of my stress related depression."
"Anonymous" –

14 June 2002

"I have been taking Seroxat for 14 months and have always suffered side-effects. I was never warned about any problems, by my GP, who prescribed them to help with my extreme anxiety."
"Anonymous" –

31 May 2002

"What more can be said about withdrawing from seroxat, it's all been said. Unfortunately G.Ps seem to be unsympathetic or very sceptical (in my experience) despite the overwhelming evidence. Seroxat may be beneficial over a short period of time, but I understand that it is not meant to be a long term solution to depression etc, on the contrary, it seems to greatly magnify the problems as well as introducing a whole host of even worse problems, especially when it comes to withdrawal."
"Heather" –

28 May 2002

"I do not feel that GP's generally have much idea of how long the process of withdrawal actually takes. The only guidelines they have to follow are those issued by the drug manufacturers, who have been shown to have misled the public."
Katie Down –

2 May 2002

"no one believed me about any of the bizarre symptoms, and i started to doubt them myself...I too got very angry with the dismissiveness of everyone around me, but given the total lack of available information, it's not really surprising. Also, trying to convince my Psychiatrist that withdrawal symptoms exist has been hard - she's not convinced by anectodal stuff and wants medical research papers...which do exist, but in small numbers. i was told my reaction was relapse, not withdrawal, and put back on it again."
"Shaun" –

April 29 2002

"While I think I have benefitted from these drugs, it seems to me that doctors tend to be quite flippant about withdrawal consequences, and I believe that they need to present their potential and treat their appearance much more seriously."
Anonymous –

6 April 2002

"Unfortunately my GP told me that the drug was not addictive so I tried to wean myself off it, though slowly. That was 1 year ago and I'm still trying, together with a therapist in Germany, where I have since moved to. Trying to convince my GP that I was experiencing withdrawal symptoms proved fruitless and finding an NHS therapist even more so. I knew I wasn't depressed anymore when I started to reduce the dose and I'm fine now - except for being addicted to paroxetine."
Tracey James –

25 January 2002

"At last! It is good to hear from someone in the medical profession being sensible and taking note… Paroxetine has done my head in. The dizzy thing was so scarey because I could not describe it and no-one knew what I was talking about. One GP leaves me messages via her receptionist, usually saying that whatever I am experiencing is normal, another has suggested that the paroxetine was masking a trapped nerve! and the Occ Health doctor at my hospital (I'm a medical secretary) has suggested cold turkey. Which is where I am now".
Tracey James –

25 January 2002

"My GP told me Paroxetine was non-addictive. That may be true in a literal sense. But if I cannot get through these constant head rushes and dizziness and go back on them (don’t worry there isn’t a cat in hells chance!) then surely that makes them addictive in a sense. I really believe that we have to let the world know what is going on. We need ways of dealing with anxiety and depression that do not involve these drugs. We need GPs to be educated and informed about them."
Cat Craig –

10 December 2001

"I came off Seroxat in a rather dramatic style almost a year ago now. I had been on it for about 9 months, prescribed by my doctor to help with panic attacks…I have never previously (or since) felt suicidal, and couldn't at all understand what had gone on until the news of other users of the drug having similar withdrawal symptoms came to my attention earlier this year. Now I am just furious that I was at no point given any warning by my GP, and was in fact told repeatedly that the drug was "not at all addictive". I lost a huge amount of friends, my self confidence and eventually my job, and it is only now that I am getting my life together again. Please, think very carefully before you start taking this medication."
Lisa Howdle –

10 September 2001

 

 

"When I spoke to my doctor about coming off the drug, he said to go from 4 a week to 3 a week to 2 a week to 1 a week, and then stop - proving that he has no idea what happens when you try and come off the drug."
Charlene

12 March 2001

"Please please is there anyone out there who has successfully come off this stuff. And can anyone tell me why the doctors don't know about these side effects? I have been to the nurses at work and they say there is nothing about any of this in their manuals."
"Anonymous" –

14 March 2001

"Have tried several times to withdraw only to experience the same symptoms as you all. My doctor still believes there are no withdrawal effects only that my anxiety returns without them. I am very depressed about being on these drugs forever. My doctor says that I have a chemical imbalance and will need them."
"Pandora" –

2 April 2001

"I ended up at the doctors to be told that withdrawal symptoms were normal - funny as I was told the tablets were non-addictive in anyway when prescribed them 2 1/2 years earlier."
"Kay" 9 May 2001
"I know more about anti depressants than my doctor who gets all her information from drug companies - and is then slow to believe someone who is actually going through the experience. I wish everyone in this situation will, when they feel better do something about it."
"Grace" – 19 May 2001 "I'm really glad I found this site…Like many others I went to my doctor and he told me he had never heard of any side effect. I think I'm going to change my doctor."
"Anonymous" –

28 July 2001

"This site, and others like it, has been invaluable as the doctors and even psychiatrists that I know had never heard of Seroxat withdrawal and thought I had a virus! I was so scared of the wierd feelings in my head that I decided to search the web and here I am feeling 100% better just from knowing that I am not going mad!…I'm getting ready to go to my GP and other doctors that I know next week having printed off some of these sites - it looks like a big education exercise is needed for medics out there. I hope the rest of you will do the same."
"Rachael" –

5 September 2001

"I haven't tried to 'come off' the drug yet, but a few times I have forgotten to take a dose and have suffered as a result. I thought that I was imagining things, that I couldn't be suffering withdrawal symptoms after only one day, but now I'm not so sure. I was assured that this was not an addictive drug, because that was one of the things that worried me, and now feel I have been misled by a person in a position of trust - my GP."
Roger Bradley –

20 April 2000

"My GP wrote to me three weeks ago asking me to go and see him regarding my continuing use of Seroxat. When I saw him I described the results of a previous attempt to stop, vertigo, mood swings etc. He stated he had never heard of any withdrawal effects related to this drug!!! I couldn't believe it. I knew about, I'd read about it, a pharmacist I'd talked to knew about it. But my GP professed ignorance."
Sean Moore –

1 June 2000

"My God, I cannot believe how many others are/have experienced the hellish withdrawal effects of coming off Paxil!?! I have been going through a personal hell the past 5 days as I have discontinued my Paxil addiction. The doctor(s) tell me I am experiencing the flu and they have never heard of this before. I feel like I am going insane and have no one to turn to for help."
"Sally" - 14 June 2000
"I've been on SSRIs since Oct 1994. Like you I've had great trouble coming off. I haven't jumped around the different SSRIs in the same way - just stuck with paroxetine - something about "better the devil you know" (although I'm beginning to wonder)...After three or four failed attempts to come off - and plunging into terrible depression/anxiety again - it has now taken me from June 1998 to the present to reduce from 20mg - 7.5mg…I'm furious about the whole thing and feel my life has been messed up big time over the last 6 years by this drug...I suppose I'd rather feel ok (and very angry) on it than totally shitty off it. I'm treating it like Valium (ie mega small reductions)- but there doesn't seem to be anyone around to help advise on this (or who's willing to admit it's addictive or just take what the patient is saying as a good indication of what's going on). My current GP has never heard of PXT withdrawal and still claims it's non addictive. My last GP took me seriously and has now stopped prescribing it himself - doesn't help me though."
David Watson –

30 July 2000

"Whenever I have visited my local GP, he is under the impression that there are no withdrawal symptoms coming off Seroxat (Paroxetine). How wrong he is! This is about the third time I have tried to wean myself off these tablets - the two previous times that I have attempted this have failed and I have had to up the dose to the previous level. "
"Jane" – 3 November 2000
"Where do we start over here??? It hasn't even filtered down to GP level yet. I still can't find a sympathetic/knowledgeable doctor. Have just had to research and get on with it all alone."

 

Contents page
List of correspondence with MCA/CSM