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Wednesday, April 03, 2013

Alistair Benbow on Seroxat/Paxil Addiction


Former GSK Head of Psychiatry Alastair Benbow




The following is taken from a BBC transcript, much of which never went to air.

It's an interview with GlaxoSmithKline's, then Head of Clinical Psychiatry, Alistair Benbow.

Benbow, you remember, was the spokesperson who defended Seroxat... and even suggested that it may, at some point in time, be used on kids. He's not a fan of mine either, in 2008 I, apparently, caused him unwarranted distress with a video I created [see - Glaxo, An Angry Blogger And Free Speech]

The following segment was taken from a 2002 interview undertaken by BBC journalist, Shelley Jofre and focuses on Benbow's reaction when asked whether or not Seroxat [Paxil in the US] is addictive. It's a marvelous defence of a not so marvelous antidepressant.

Enjoy.

Key:

Q = Jofre
A = Benbow



Q. Your leaflet says 'remember you cannot become addicted to Seroxat', but that's not true is it?

A. Yes, it is true. There is no reliable evidence that Seroxat can cause addiction or dependence, and this has been borne out by a number of independent clinical experts, by regulatory authorities around the world, the Royal College of Psychiatrists, and a number of other groups.


Q. If people cannot stop taking a drug when they want to stop taking it they are addicted are they not?


A. No, that is not correct. The definition of addiction is not as you describe it. Addiction is characterised by a number of different criteria, which includes craving, which includes increasing the dose of the drug to get the same effect, and a number of other features, and those are not exhibited by Seroxat.


Q. That is not with respect what the Oxford English Dictionary says. It says, "Addiction is having a compulsion to take a drug, the stopping of which produces withdrawal symptoms."

A. It is true that a number of patients will experience symptoms on withdrawal.


Q. That is what addiction means is it not?

A. No, it is not.


Q. That is what the dictionary says.

A. That is not a clinical definition of addiction or dependence. Dependence is very clearly laid down by international...


Q. But when people start taking Seroxat they do not consult a medical dictionary.

A. No, and they will not consult the Oxford English Dictionary either.


Q. The Oxford English Dictionary tells you what common usage of the word addiction is. People understand that if they cannot stop taking a drug it is addictive.


A. The reality of the situation is that regulatory authorities around the world, independent clinical experts and key groups like the Royal College of Psychiatrists, have agreed that Seroxat is not habit forming or addictive.


Q. But your patient leaflet is meant to help and inform patients is it not?

A. Yes, it is, and it does I believe.

Q. Not according to the people we have spoken to who feel they were not warned that this could happen to them. They read, "You cannot become addicted to Seroxat" and thought they could stop the drug any time they wanted.

A. No, the reality is they can stop the drug, but it is true...


Q. But you cannot stop any time you want.

A. Yes, they can and the information clearly says that Seroxat is not addictive, and it is not. It is true that a proportion of patients may develop symptoms on stopping the drug. These are generally mild to moderate in nature ... [Inaudible due to interruption] permitting, and will go away usually within a two-week period.


Q. I am sorry, I must take you back to this because the dictionary says, "having a compulsion to take a drug, the stopping of which produces withdrawal symptoms", and we have spoken to plenty of people who say they are compelled to take Seroxat because stopping it produces withdrawal symptoms. They are addicted.

A. If you use that limited description of addictive then most prescription medicines could be defined as addictive. Beta-blockers, which are used for the treatment...


Q. This is the common usage of the word. This is what people understand "addicted" to mean, and you are misleading them in the patient leaflet by saying they cannot become addicted.

A. No we are not misleading them. The information in the patient leaflet, and in the information supplied to doctors, is based on fact. It is based on data, which is generated during clinical trials and during the marketing of the product over the last ten years.


Q. Do patients' experiences count for anything in this?

A. Of course patient experiences count for something, and we take the safety of our medicine extremely seriously, and we take into account all the adverse events that are recorded throughout the world and report them to the regulatory authorities. It is on that data on which decisions are made as to what should and should not be in our leaflet and in the information to doctors. The regulatory authorities are very, very clear on this issue. There is no reliable scientific evidence that Seroxat causes addiction or dependence.


Q. It sounds to me that you are hiding behind the medical definition of addiction. The World Heath Organisation says that proper dependence is "a need for repeated doses of a drug to feel good or avoid feeling bad". We have spoken to countless people who are on Seroxat and the only reason they are still on it is because they cannot stop taking it - they feel too bad when they stop taking it.

A. As a doctor it is my duty to inform patients on the risks and the benefits of our medicines. It is important...


Q. You say it is doctor's responsibility, not yours?

A. No, I am saying as a doctor myself it is my responsibility for my patients to inform them of the risks and benefits of an individual product. Now we help doctors supply information...


Q. But this is not helpful! What I am telling you is that we have spoken to countless people who feel that they have been misled by the patient leaflet. It says you cannot become addicted to Seroxat, and by any definition that the public might look at they are addicted.

A. No, I am sorry I have to disagree with you. When you look at the data it quite clearly shows that on all the models when you do trials in animals - when you look at the data in patients considering taking this in the context of tens of millions of patients who have been on Seroxat over the last ten years - the data clearly shows that this class of drugs, and Seroxat in particular, does not cause addiction or dependence.


Q. It does not cause addiction if you use the medical definition perhaps, but what we are talking about here is information that helps people to make an informed choice when they go on a drug, and that leaflet is misleading them because they think they can stop the drug any time they want. They cannot can they?

A. Yes, they can.


Q. But they cannot. It is quite obvious that there are large numbers of people who cannot stop taking the drug because the withdrawal symptoms are causing them too much distress.

A. With respect, patients can stop taking Seroxat. Of course they should be taking it in consultation with their doctor...


Q. There are some people for whom the withdrawal symptoms are really quite terrible.

A. I understand that, and I have every sympathy with patients who are having difficulty...

Q. So you accept that some people will have a very difficult time coming off the drug, but they would not know that from reading your warning.

A. There is a very small percentage of patients who will experience difficulty coming off Seroxat and a range of other therapies.


Q. But they would not know that, would they, when they are on it?

A. It would be absolutely scandalous if we were to put in our patient information, information that was not correct and we are not going to do that.


Q. But you are misleading people because if you say you cannot become addicted to Seroxat it makes people think it is a benign drug that you can stop taking any time you like.

A. No, that is not correct. We are not misleading the public at all. We are providing factual information that is correct.


Q. If you look at the patient leaflet it also says "withdrawal symptoms from Seroxat are not common". That is not true either, is it?

A. Yes it is true. That information is absolutely accurate. Withdrawal symptoms are not common.


Q. Doctors report far more withdrawal problems with Seroxat than with any of the other anti-depressants.

A. If you are referring to list withdrawal symptoms then in the context of tens of millions of patients who have received Seroxat around the world the numbers of withdrawal symptoms are actually very low.


Q. But you agree Seroxat is far and away the worst offender for withdrawal problems.

A. What I am saying is that in those lists the absolute number of reports, which are relatively low in the context of the tens of millions of patients who have received Seroxat, it is at the top of the list.


Q. The side effects are always notoriously under-reported by doctors. The fact is that Seroxat tops every single list there is of withdrawal problems.

A. The reality is that when you tell people about these side effects, as we have done - we have warned them in the patient information leaflet and we have told doctors about symptoms on withdrawal - it is more likely they are reported. However there are many other confounding factors.


Q. Excuse me if I do a little basic arithmetic here. Seroxat is prescribed slightly less than Prozac, and yet the complaints about Seroxat withdrawal problems are far and away the highest out of any anti-depressant.

A. Let me just tell you a little bit of technical information...


Q. That is true is it not!

A. It is true that in those particular lists Seroxat does feature at the top of the lists.


Q. And why is that?

A. For reasons that I have already outlined you have to take on board a number of different factors, one of which is the frequency of prescribing of the drug. However there are other factors, like the amount of drug that is in the blood over time, so the half-life of the drug ie. how quickly the drug is washed out of the system is also important. With Prozac, for instance, the half-life of the drug is very long so there is therefore a long time between stopping the drug and experiencing symptoms, so long in fact that many people may not recognise that the symptoms they get on stopping are related to the drug. Whereas, of course, when you have a short half-life - and for a product to wash out of the system quickly is a very beneficial thing - then they are more likely to recognise it.

However these symptoms on withdrawal are common to all anti-depressants, not just the SSRI's and is common to many, many other drugs, including treatment for high blood pressure, cardio-arrhythmias and so on.


Q. It sounds like you are trying to say that Seroxat is no different to the other antidepressants, but whatever evidence you can count that is simply not true. Talking to patients, talking to doctors, and looking at any list that complies lists of withdrawal problems, Seroxat is much worse than the other anti-depressants.

A. What I am saying is that you cannot compare absolute numbers...


Q. You must accept that surely?

A. No, I do not accept that. It is my fundamental belief that Seroxat and the other antidepressants of all classes cause symptoms on withdrawal.

Q. There is no difference between Seroxat and the other anti-depressants?

A. There may be a difference in the number that are reported on occasion because we-

Q. Because there are more problems?

A. Because we have highlighted the fact these sort of symptoms have become more apparent since Seroxat was made available, and there are many other factors which need to be taken into consideration as the regulatory authorities will tell you.

Q. Have you looked on the internet, or spoken to patients about this?

A. Yes, I have and actually the majority of patients do not have a problem.


Q. Tell me about the patients who do have a problem because their problems are very real indeed. Your leaflet says 'withdrawal symptoms will generally disappear with a few days'. Have you looked on the internet and seen some of the horror stories?

A. Yes, I have looked on the internet but I have to tell you that the majority of patients who experience withdrawal symptoms - and the majority of patients actually do not experience any withdrawal symptoms - of those that do the majority of those symptoms are mild to moderate in nature and will go away without any treatment within two weeks.


Q. You say you have looked at the internet and spoken to patients, but why have you not heard the stories we have heard of people who are having a terrible time? Sometimes they cannot get off it, other times it takes them a very long time indeed and lots of unpleasant withdrawal symptoms.

A. Of course I have read those same stories. Most of those...


Q. So, they are true are they not?

A. Most of those I have seen in the media and we cannot be driven by anecdote; we have to be driven by facts. We do not...


Q. So you do not listen to patients?

A. Of course we listen to patients. We listen to patients all the time, but the reality is that we have to consider the facts and we will collect data and we do, and the regulatory...


Q. These are facts!

A. And the regulatory authorities collect the facts and data, and then they make a decision as to whether these things should be changed in our label.


Q. Are you saying that these patients' stories are not fact? Do you think they are making it up?

A. No of course I am not saying that. What I am saying is that if you look at the totality of the data - and yes it maybe that a small proportion of patients do get more severe symptoms but in totality of the total patients taking Seroxat, an extremely effective and valuable medicine for the treatment of this severe disease, depression, which kills many people...


Q. It is not just for depression that people are taking the drug.

A. Indeed not - for depression and other anxiety related disorders, all of which have a common feature of being debilitating and stopping people functioning properly.

However, in that context I believe, the company believes, the regulatory authorities believe, and the independent clinical experts believe that the majority of these symptoms on withdrawal are mild to moderate in nature, self-limiting and go-away in the majority of cases within two weeks. Now these symptoms can also be helped if you gradual taper the medicine on withdrawal and that information is in the information that is provided to doctors and to patients.

Q. How long should it take then if you taper the withdrawal?

A. That depends on the dose of Seroxat that the patient is on. In the majority of cases, if you are on one of the higher doses, it will only take a matter of weeks.

Q. We have been filming with a woman - she has actually filmed her own attempts coming off Seroxat - and it has taken her nine months and it has been absolutely horrendous! She has been unable to leave the house on a large number of occasions as the symptoms have been so bad.

A. With respect you are taking, yes I grant an extreme example, which is very disabling...


Q. It hardly an extreme example if you look on the internet!

A. If you will forgive me for saying so, it is an extreme example because although there may be a whole range of anecdotes on the internet, there are also many, many millions of patients who have taken Seroxat for this disabling and stressing condition...



Q. Nobody is denying that a great many people have been helped by this drug. What we are talking about is the information you provide for patients and whether it is accurate. If somebody goes on a drug and they are told they cannot become addicted, withdrawal symptoms are not common and they are generally going to disappear within a few days, you would forgive them for being a little angry when nine months after trying to stop they are still on the drug!

A. I think you will find that the information you just said that is in the patient information leaflet in the summary of product characteristics is accurate, balanced and not misleading.


Q. What warning would there be for anyone who goes through this horrendous withdrawal process?

A. No, what we have said...


Q. There is definitely no warning that they might experience this is there?

A. It is important to understand that what we are trying to do is label for the usual situation. Of course, in medicine and in...


Q. The woman I am talking about took this drug for panic attacks. If she had known at the time that she was going to go through this horrible withdrawal from the drug, she would never have taken it. She would have managed her panic attacks in a different way. She was not properly informed and she is pretty angry.

A. This is an extreme example...


Q. It is not an extreme example.

A. It is an extreme example. The vast majority of patients, as we quite clearly say in our label, have no problem coming off Seroxat. Indeed...


Q. So it is just your tough luck if you happen to have a hard time?

A. No, of course not. I have every sympathy for any patient that has difficulty coming off Seroxat but that is not what normally happens. The vast majority of patients who take Seroxat will not experience any difficulties coming off it.


Q. The fact is that you do not know what normally happens because you do not have a published study that has actually looked in into the single question of addiction and withdrawal problems have you?

A. We have actually looked very carefully at...

Q. No, you have not conducted a study looking into withdrawal problems have you?

A. Yes, actually in all of our clinical studies we have looked to see where there are symptoms...

Q. No, a study designed to look at withdrawal symptoms.

A. We have specifically in all our recent studies looked carefully to see the proportion of
patients who get withdrawal symptoms.

Q. I am afraid you are not really answering the question.

A. Yes, I am.

Q. You have not done a study - a single study - looking purely at withdrawal symptoms have you?

A. What we have done is conducted clinical trials...

Q. Can I take that as a "no"?

A. No, you cannot take that as a "no". What you are saying is incorrect. To study withdrawal symptoms you have to have patients on Seroxat who you then follow during the withdrawal phase. That is exactly what we have done across a range of different indications, and quite clearly that information from those clinical studies
completely supports what we have in our leaflet.


Q. Can you show me the study that was designed to look at withdrawal problems?

A. I can show you a range of different studies that are designed to look at withdrawal symptoms and I can tell you the findings of those studies. In those studies approximately 7% of patients experience dizziness, 2% of patients experience abnormal dreams and 2% experience sensory disturbances. All the other adverse events that were seen on the form were at a lower frequency than that, and it should be remembered that patients who came off placebo also experienced withdrawal symptoms in some cases.


Q. You are not suggesting Seroxat's withdrawal problems are the same as sugar pills are you?

A. No, I am not, but what I am saying is that in interpreting data you have to take on board the consideration of a proportion of patients who take dummy pills who will also experience symptoms.

The interview then moves to the subject of Seroxat induced suicide.


One has to ask here if Glaxo's spokesperson was being honest. A year previously, in 2001, a lawsuit was filed in the US which claimed that Seroxat caused severe withdrawal problems.


The lawsuit showed that GSK deliberately misled both physicians and patients into believing that Seroxat was not addictive and had no or only rare withdrawal reactions with a question and answer pamphlet distributed to doctors' offices to be disseminated to patients, in which GSK asks the question: "Is Seroxat addictive?"

And, in response, the pamphlet states: "Seroxat has been studied both in short-and-long-term use and is not associated with dependence or addiction."

By the time the lawsuit was filed on August 21, 2001, the plaintiffs' attorneys, Baum Hedlund law firm, had been individually contacted by approximately 5,000 Seroxat withdrawal victims.

As a result of GSK's fraudulent marketing of Seroxat Baum Hedlund law firm won a major settlement in this class action filed on behalf of patients who got hooked on the drug, and in many instances, found they were unable to stop taking it. Sadly, because of the settlement, depositions and other important documents were sealed away from the public.

The documents that did surface during litigation showed that before Seroxat was approved, GSK had known about the withdrawal effects from it own clinical trials.

According to the lawsuit's complaint, "GSK's motive of deliberately failing to advise physicians and the public of the adverse effects that can lead to withdrawal problems (and that it knew a percentage of users of the drug inevitably would experience) was for financial gain and its fear that, if properly labeled the drug, Seroxat would lose its share of the SSRI market."

The now infamous 'money bag' memo also appeared during litigation [fig 1]. This showed clearly why Glaxo wanted to play down the dependency issue - something that Benbow, it seems, did a year later on BBC television.




fig 1


In fact, in 1997, some 5 years before Benbow's interview with Jofre, GlaxoSmithKline had sent a memo out to its 'Paxil selling team'.

The memo, from Bill Kinnear and Barry Brand, refers to 'discontinuation syndrome' [withdrawal] and they blame Eli Lilly for mudslinging about Seroxat withdrawal due to the fact that Lilly's Prozac had come under scrutiny for causing severe adverse withdrawal reactions.

Kinnear and Brand instructed the sales team [Glaxo reps] with the following: [fig 2]

fig 2 - click to enlarge

It seemed to be one big joke for Glaxo, as the cartoon image of a patient screaming for his Paxil taken from the same document shows [fig 3]

fig 3 - click to enlarge

GlaxoSmithKline, although settling 5,000 withdrawal cases in the US, still refuse to admit that Seroxat is addictive, still refuse to answer patient questions regarding how one should safely taper from Seroxat, still refuse to meet with patient representatives [ See - GSK's Andrew Witty in Patient Aftercare Snub], still defend their corner, the UK Seroxat lawsuit has never been settled, GSK contest that Seroxat causes withdrawal problems to patients in the UK, a case that has been on-going for approx 7 years.

In fact, Benbow throughout the above interview, refuses to budge on his [Glaxo's] addiction stance, strange then that in the same year as he was interviewed lawyers in America sought a preliminary injunction on behalf of thousands of Seroxat class members as well as individuals who, it was argued, "might be persuaded by the commercials and brochures to take Paxil in the future." Once again it was Baum Hedlund who put a stop to GlaxoSmithKline's TV advertisement claiming that Seroxat was "Non Habit-Forming". [See Paxil Ad Injunction]

More about the UK lawsuit with the 4 links provided at the end of this post, you'll note the MHRA's involvement with the UK Seroxat litigation, a former employee of the MHRA is an 'expert' witness for GSK. You'll also note from the above Benbow interview that he refers to the MHRA as the 'regulator'.

So, is Seroxat addictive?

My answer to that is in my book, The evidence, however, is clear...the Seroxat scandal.

As for Benbow, he no longer works for GlaxoSmithKline, he is now Executive Director of the European Brain Council [EBC]

Coming next: Alistair Benbow on Seroxat/Paxil suicide.



UK Seroxat Lawsuit Links


GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money



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