Alastair Benbow: The Devil is in the Details

First off, I'm not a mathematician. Maths, or if you're American, math, is another language to me, in fact, for me at least, it would be easier to learn Chinese than it would to grasp maths. I was the kid at the back of the classroom who still counted on his fingers underneath the table, out of view of those who were better at numbers than I.

I was going through some of the archives and recent media articles regarding the original 329 study.

There were 275 subjects in the 8 week trial, 12 of whom had suicidal thoughts (in the paroxetine arm)

12 suicidal thoughts out of 275 subjects = 4.363636363636364%

Okay, out of the 275 subjects, 90 were on paroxetine. The table below is based on efficacy results for 90 patients. The actual figure of adverse events was based on 93 patients but I'm keeping the figure at 90 for ease.

12 suicidal thoughts out of 90 subjects = 133.33333333333334 (Roughly 13%)

Given there were approximately 2 millions prescriptions for paroxetine written for adolescents one year after the study was published in the JAACAP this means, if I have my maths correct, that...

133.33333333333334 of two million = 266,666

In 2003, GSK's then Head of Psychiatry, Alastair Benbow (pictured above) went on national television and claimed that, "less than a small class size would have these suicidal thoughts." (video below - 1 minute 21 seconds, Alastair Benbow

Benbow's 'small class size' is a classroom, therefore, that can fit 266,666. pupils. What school did Benbow attend?

Okay, so two million prescriptions does not necessarily mean two million adolescents. The two million prescriptions may have been repeat prescriptions to individuals. So, lets say the number of individuals written a prescription is between 200,000 and 2,000,000

Whatever way you slice it, Alastair Benbow must have gone to an awfully big school!

To put this into some sort of perspective, America de Cali, a Columbian football team, play their homes games at the Pascual Guerrero stadium which holds some 33,000 spectators. So, if 250,000 individuals were given prescriptions for paroxetine one year after the JAACAP review by Keller et al had been published, Benbow's small classroom would have looked something like this...

If 500,000 individuals were handed out prescriptions for paroxetine then Benbow's small sized classroom would have resembled this (Kingdome, Seattle - now demolished)

Okay, let's give Benbow the benefit of the doubt here and say that just 175,000 individuals took paroxetine one year after the JAACAP review.

That would give us (excuse the Devil numbers) a class size of 16,666 pupils.

In other words, Benbow's small sized class could be compared to the Nilson Nelson Gymnasium in Brazil (pic below)

Furthermore, and once again cutting Benbow some slack, let's say just 87,500 took paroxetine one year after the JAACAP review - that would still give us a pretty large classroom,   - 8,333 pupils.

An averaged sized class (not small sized class) in the US was between 19 and 26 pupils in 2011/12. (Source)

Remember, Benbow claimed that, "less than a small class size would have these suicidal thoughts."

What exactly is less than small? English language and usage may be worth looking at to understand what Benbow was actually saying. (Smaller vs. less vs. lesser) Maybe it was yet more coding from GSK (see http://study329.org/) for explanation of "emotional lability"

Maybe Benbow was talking about the 12 patients who had suicidal thoughts that the restoration team found... or maybe he was talking about the 6 that Keller et al found?**

Either way, it was an extremely poor choice of words to use. Perhaps Benbow should have used the same criteria I've used here, although going on national television and saying something like, "We believe that between 8,000 and 266,000 would have had these suicidal thoughts one year after our study was reviewed and published" , wouldn't really have gone down too well with GSK executives, or, indeed, their shareholders.

Truth is over two million prescriptions were written for children/adolescents one year after the Keller study was published. It is unknown how many children/adolescents were individually prescribed paroxetine, it's believed to be, as I mentioned, between 200,000 and 2,000,000. Even if the figures are less we still see a potential for thousands of adolescents and children that may have been at risk of suicidal thinking. One also has to take into account that these figures are based on US prescriptions only. Add to it prescriptions written for adolescents and children in other countries and we have stadiums bursting at the rafters!

Maybe a more striking headline regarding the recent restoration study findings should have been 'Between 8,000 and a quarter of a million kids put at risk one year after flawed paroxetine data published.'

The interview with Benbow (below) is from 2003, some two years after the Keller paper was published.

As I said, at the top of this post, I'm not a mathematician so I may be totally wrong with these figures. When Benbow said , "less than a small class size would have these suicidal thoughts", I took it as maybe 10, or 20 at the most. Truth of the matter is, in an 8 week clinical trial 12 patients, who were taking paroxetine, suffered suicidal thinking - that figure may be higher because none of the 90 (93) patients given paroxetine in the 8 week trial were followed up, in other words, more may have had suicidal thinking after the 8 week period. The patients who dropped out before or at the 8 week point weren’t properly followed up – who knows what the story was behind the patients reported as just being ‘lost to follow up’ or ‘consent withdrawn’ for example.

Some patients did go on to take part in a 6 month continuation phase and these were followed up at various points, but this data has never been published.

If any statistician stumbles on this post of mine they may be able to clear things up for me?



**Keller et al only classed 5 of 6 as serious adverse events (suicidal ideation/gestures)





Bob Fiddaman

Related

Reanalysis of Glaxo's 329 Study Goes Public

329: The Aftermath - Karma Chameleon

15 Good Reasons Not to Trust Andrew Witty and GSK

Glaxo CEO, Andrew Witty

GSK Head, Andrew Witty and his recent announcement about transparency could possibly be believed if one were inclined to be gullable. See here, Glaxo's Murky Transparency Claim

He blamed the recent $3 billion guilty plea for off-label promotion of GSK drugs that not only harmed but killed people on an era. See here, GlaxoSmithKline: The Andrew Witty "Era"

Do we, as consumers, really think Andrew Witty is being sincere with his latest offering? He, as recent as last year, refused to meet with Janice Simmons, founder of the Seroxat User Group, to discuss the 15,000 emails she has amassed from patients who are struggling to withdraw from his company's antidepressant, Seroxat. See here, **Exclusive - GSK's Andrew Witty in Patient Aftercare Snub

Witty's backroom staff and predecessor's have also made promises and outrageous statements in the past.

Glaxo, and indeed other pharmaceutical companies, are always telling doctor's and patients about the benefit vs risk of taking their antidepressant medications.

Like Witty, I'm coming up with my own benefit vs risk ratio. Can he, or indeed his company, GSK, be trusted to deliver the goods this time around?

Former GSK Head Launches "The Year of the Brain"

Former GSK Head of Psychiatry Alastair Benbow

Alastair Benbow. Now there's a name.

Benbow and I go back a long way, well my criticisms of him do. He knows who I am, which, I guess, is quite flattering considering I'm just a former Seroxat patient with a gripe against his former employers, GlaxoSmithKline.

GSK, Not So Corporate

 

Back Story

GSK Lawyers target Seroxat campaigner Bob Fiddaman – what next?

Read more in my book, links below.

Fid


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Win A Signed Copy of Seroxat Book

Up for grabs is a signed copy of my book, The evidence, however, is clear...the Seroxat scandal - Chipmunka Publishing.

All you have to do is come up with a witty caption for the photo below which sees former GlaxoSmithKline employee and Seroxat spokesperson Alastair Benbow meeting with the Pope.

You can enter by emailing me HERE

Need help?


Watch this 8 minute video, which sees the former Glaxo employee talk about Seroxat. He's joined by MHRA Chairman, Alasdair Breckenridge, who also "bigs up" Seroxat.








Good Luck!


Fid

GSK Respond - "Dr Benbow is no longer with GlaxoSmithKline."

Some of you may know that I have been requesting information from British pharmaceutical giant GlaxoSmithKline regarding comments made by their employee Alastair Benbow on national TV and to BBC investigative journalist Shelley Jofre.

A recent document that surfaced shows an exchange of words between Benbow and Jofre from October 2002. This actual transcript shows Jofre press Benbow for an answer regarding Seroxat withdrawal, much of the transcript never made the final edit.

My request to GSK was thus:

To whom it may concern,

1. In a 2002 interview with BBC TV's Shelley Jofre, GlaxoSmithKline spokesperson, Alastair Benbow, claimed 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." He was, of course, referring to the antidepressant Seroxat. Under the FOIA I would like GlaxoSmithKline to provide me with the study/studies that substantiate Dr Benbow's claim.

2. Furthermore, in the same interview, Dr Benbow claimed, "maybe that a small proportion of patients do get more severe symptoms...". Under the FOIA I would like GlaxoSmithKline to provide me with the study/studies that substantiate Dr Benbow's claim. The full transcript, which has recently been released, was part of disclosure and used in litigation against GSK in the United States and is attached for your perusal.

Yours sincerely,

Bob Fiddaman

On Thursday August 11, I wrote a scathing article and published it on my blog. An hour or so before I published the article I announced on Twitter, "**Exclusive - GSK's Andrew Witty in Patient Aftercare Snub - Keep your eye on the Seroxat Sufferers blog" [Fig 1]

Fig 1

At 4.47pm, just 13 minutes before I was due to publish my article, GSK replied to my request, a request that I had sent them three times!

When I say replied, it was basically GSK side-stepping what I had asked for.


Here's the reply:

Dear Mr Fiddaman,

Thank you for contacting the Medical Information Department at GlaxoSmithKline regarding our product Seroxat* (paroxetine hydrochloride hemihydrate) and thank you for providing us the transcript of the Panorama interview.

You have requested information on study/studies that substantiate some selected quotes from Dr Alastair Benbow with regard to Seroxat during that interview back in 2002. Dr Benbow is no longer with GlaxoSmithKline and therefore it would be inappropriate to attribute substantiation data to him without any consultation. However, the tenor of what is quoted is supported 9 years later in the current prescribing information for Seroxat, namely that:

· in clinical trials adverse events seen on discontinuation occurred in 30% of patients treated with paroxetine compared to 20% of patients treated with placebo;

and

· generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity;

and

· generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more)

For your information some of the clinical trial data for paroxetine in terms of nature and frequency of withdrawal reactions are available in the public arena and discussed via the information presented on p126 of the CSM EWG report of 2004. Lastly, and as before, information about GSK’s clinical trials is available on the GSK Clinical Trial Register at GSK.com.

You will notice GSK's selective choice of words, such as, “generally” and “most”. What I actually requested were the studies that could back up Benbow's claims. So I wrote back the following:

Dear GSK,

With respect, you have not provided me with the information I requested.

Your employee, Alastair Benbow made the statements on national TV.

I would like to see the evidence that backs his claims.

If I wanted a snapshot of a patient information leaflet I would have downloaded one. You are not being transparent here.

Best

Bob Fiddaman

As yet, GSK have not replied to me.

It is interesting to learn that Alastair Benbow is no longer with GSK, quiet convenient that the one person who has the answers to why he said what he did no longer remains as GlaxoSmithKline's spokesperson.

So, in essence, I have requested studies that back up Benbow's claims - GSK cut and paste information off the Seroxat patient information leaflet and send it to me.

Clearly not good enough! I'll keep you posted should GSK ever send me the evidence that supports Benbow's claims.

Back story: **Exclusive - GSK's Andrew Witty in Patient Aftercare Snub



Fid 

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MHRA On GSK's Dr Alastair Benbow

What are Dr Alastair Benbow's sources?

From: fiddaman robert
Sent: 25 June 2011 13:08
To: MHRA Central Enquiry Point
Subject: FOI Request

- Show quoted text -

MHRA Information Centre


The following request I make under the Freedom of Information Act.



To whom it may concern,

1. In a 2002 interview with BBC TV's Shelley Jofre, GlaxoSmithKline spokesperson, Alastair Benbow, claimed 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." He was, of course, referring to the antidepressant Seroxat. Under the FOIA I would like the MHRA to provide me with the study/studies that substantiate Dr Benbow's claim.

2. Furthermore, in the same interview, Dr Benbow claimed, "maybe that a small proportion of patients do get more severe symptoms...". Under the FOIA I would like the MHRA to provide me with the study/studies that substantiate Dr Benbow's claim.

The full transcript, which has recently been released, was part of disclosure and used in litigation against GSK in the United States and is attached for your perusal.

Yours sincerely,

Bob Fiddaman

Dear Mr Fiddaman,

Thank you for your recent enquiry to the MHRA.
We cannot give you a definitive answer, we would advise you to contact GSK directly to ascertain what studies Mr Benbow considered supported his statement. Any studies he may have considered should have been published on our website. You may wish to review the SSRI Expert Working Group report published on our website (link below), the report outlines all the data the Agency has considered in relation to the issue of withdrawal reactions with Paroxetine.

http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON1004259

The Agency has previously released relevant data that has been submitted to us with regards to withdrawal reactions and also data submitted to us by GSK in the context of this review and the European Article 31 referral, which is also available on the GSK website.

Please contact us again if you need further assistance with this, or any other queries.


Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

I sent the same FOI to GlaxoSmithKline - they never even bothered to acknowledge receipt of it.

Transparent as ever!

Fid


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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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How Glaxo Wanted to Turn the Issue of Withdrawal in Their Favour

One would think that a manufacturer of a product would act upon a defective product, particularly if that product was to be used by millions of people.

Glaxo launched Seroxat in direct competition to Eli Lilly's Prozac. Lilly, being Lilly, saw this as a threat. So battle did commence.

According to this recently surfaced internal file, GlaxoSmithKline [then SmithKline Beecham] knew of two studies that Lilly had carried out, those studies showed that Seroxat showed significantly higher rates of withdrawal problems when compared to Prozac.

How did GSK handle this?

Well, instead of addressing Lilly's findings they decided to play down the issue of Seroxat withdrawal. The fact that Seroxat withdrawal problems were significantly higher than Prozac saw Glaxo's team pull together the following plan.

Downloaded from DIDA Library

Downloaded from DIDA Library

You will note the date of the letter is July 1997, that's 14 years ago.

Let's catapult to present day, 2011, and an article I ran with on June 19.

GlaxoSmithKline UK had been contacted by a patient because she was at her wits end. She had, for some years, being struggling to withdraw from Seroxat. This was frustrating because she wanted to start a family and she knew the possible consequences of trying for a baby whilst hooked on Seroxat. Seroxat is a teratogen for those of you that don't know - The British drug regulator, the MHRA won't admit that it is though.

14 years on and, it appears, Glaxo still don't want to address the issue of Seroxat withdrawal. The woman who contacted them was told, not by Glaxo but by one of their lawyers, that Seroxat was not addictive and that she should "talk to her doctor."

The fact that this woman had already spoken with her doctor, who had no idea how to tell her to taper or how long it would take, seemed irrelevant to GlaxoSmithKline's lawyer!

"Zoe's" full story can be read HERE.


With Glaxo refusing to acknowledge those that suffer serious withdrawal problems at the hands of their product, we have a cluster of people who have been thrown onto the scrap heap. In a previously unseen BBC transcript [2002] from Panorama, Glaxo's Alastair Benbow told investigative journalist, Shelley Jofre, that Seroxat was not addictive, in fact he went one step further and said that people could stop taking Seroxat anytime they wanted, adding, "It is true that a proportion of patients may develop symptoms on stopping the drug. These are generally mild to moderate in nature."

It took me almost two years to quit Seroxat. For Benbow to suggest that my withdrawal was possibly mild to moderate in nature is seen as an insult. To suggest that "Zoe", the woman who featured in my June article, is possibly suffering only mild to moderate withdrawal also smacks of someone who has a characteristic of being conceited. Mine and "Zoe's" withdrawal are just two stories. Here's just a minuscule of other withdrawal comments left by people who have signed the Online Paxil Petition.

I've recently stopped taking Paxil after 18 months and have experienced many of the side effects associated with withdrawal - hot flashes, electrical "zaps", inability to concentrate, weight gain, dizziness, headaches, etc., etc., Had I been aware of these withdrawal horrors, I would have requested that my physician prescribe another medication.

I am going through hell trying to get off of this drug. I've been on it for 4 years - tried to get off of it twice, unsuccessfully, and am now trying a 3rd time. Each time I get so sick, I give in and start taking it again so that I can function. I never would have taken this drug if I would have known the consequences.

Very sick with electrical charges in head when trying to quite. This is like being addicted to hard core drugs. The manufacture needs to have a plan to withdraw people who take this. I have been sick for at least 2-3 days every time I try to decrease the dose. It's been a horrible experience. I want off this drug and no one seems to know how to stop it without getting sick.

There are more to read HERE, in fact over 10,000 more.

Glaxo's Alastair Benbow is aware of the voices on the Internet, in 2002 he had this to say to Shelley Jofre:

"...we cannot be driven by anecdote; we have to be driven by facts."

On being asked how long patients have to taper when coming off Seroxat, Benbow replied:

"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."

Maybe Benbow still remembers the 'plan' his employers set out in 1997 to basically debunk the withdrawal problems of Seroxat?

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Related article:

Previously Unseen Paxil GlaxoSmithKline Court Documents Part I