Thursday, March 26, 2015

Co-pilot, Andreas Lubitz Germanwings

I, like many, watched the various press conferences this morning.

I, like many, was shocked to learn that 28 year-old co-pilot, Andreas Lubitz, deliberately flew the aircraft into a mountain.

So, most obvious questions coming from the media frenzy.

"Do you know the religion of the co-pilot?"

"Do you think it was a terrorist attack?"

"What was the mental state of the co-pilot?"

All valid questions that provided negative answers.

So, the most obvious question, to me at least, would have been this...

"Do we know if the co-pilot was on any form of medication?"

Gasp! Oh no, not one of those anti- psych meds nutters asking questions?

Not one single newspaper or TV/Radio journalist posed this question at any of these press conferences. Why is that?

Now, I'm not going to go down some sort of conspiratorial road and suggest that they are not allowed to raise such questions. To be quite frank, reporters will always try to ask the questions that gets them the scoop.

I believe that reporters did not ask this one simple question because they just don't believe that a person taking medication can lose his mind. In any event, even if Andreas Lubitz was on medication it would be pretty hard to prove that his actions were induced by the pharmaceutical product.

In the main, the media tend to shy away from reporting about the medication, opting instead to report on the "illness."

We've seen it time and time again. Joe blogs was depressed and under the care of a psychiatrist, that's why he killed himself.

John Doe had recently split from his girlfriend, that's why he walked into a school and shot his classmates and teacher dead.

Rarely do they report that the "perp" was taking medication. Even if they do, it's pretty vague.

"Joe Blogs was believed to be on antidepressants." or "John Doe, it is reported, had recently started taking medication."

The brand names are, perversely, excluded from the media reports. Wouldn't you like to know the name of a product that made someone crazy?

Now, I'm not suggesting that Andreas Lubitz was on any form of medication but I, for one, would love to know whether or not he was, if only to then ask all the airlines what the protocol was for pilots taking psych meds.

Back in 2010 I received confirmation from the Federal Aviation Administration [FAA] that the antidepressant paroxetine, better known by its brand name of Seroxat [UK and Paxil [US] did not make the "Safe list" of medications to take whilst operating an aircraft. However, the FAA, who at the time were looking at lifting their ban on pilots flying whilst taking medication, had suggested that other SSRi's, namely  Fluoxetine [Prozac], Sertraline [Zoloft], Citalopram [Celexa], or Escitalopram [Lexapro] were safe to take whilst operating an aircraft.


Investigative journalist Evelyn Pringle and I corresponded and she wrote a quite brilliant article regarding psychiatric medication and pilots entitled, SSRIs Render Unfriendly Skies.

All the documents I received from the FAA can be viewed online here. They were obtained under the Freedom of Information Act.

Personally, I think the media have come to accept that SSRi's can induce suicide. Homicide though? They just can't swallow that particular pill.

In other news, Florida Teen Kills Brother, 6, Self After Food Dispute,

"Authorities in Florida are investigating what motivated a 13-year-old boy to apparently fatally shoot his 6-year-old brother, wound his 16-year-old brother, and then turn the gun on himself Wednesday."

No doubt, the anti-psych drugs brigade will have something to say about this. No doubt they will once again be labelled conspiracy theorists.

You know, just because we report on the things that the media won't touch does not make us conspiracy theorists.

Back to retirement.

Bob Fiddaman.

Saturday, March 21, 2015

Book Update - No Other Man

I've uploaded the first 13 chapters of No Other Man online.

I'm quite happy with the first 13 but may go back at some stage to re-edit.

I'm up to 56,000 words and, hopefully, by September, will have reached my intended target of 80,000.

The one page prologue kind of sets the tone. I'll write a synopsis of the book once I've finished it.

Here's the first 13 chapters.

Bob Fiddaman

Literary Agents and/or Publishers can contact me via email.

Email Me

Monday, March 16, 2015

King & Spalding US Attorneys in Ignition Switch Scandal

I said privately to many friends that it would take a lot to get me writing again on this blog. Anything that Glaxo do now or in the future won't shock or surprise me. They've done it all so nothing shocks me anymore about their behaviour.

For those that don't know, Glaxo have, in the main, been defended by US Attorney's King & Spalding. Paxil birth defect litigation, Paxil suicide litigation and Paxil withdrawal cases. In the legal circles one only has to mention King & Spalding and the Glaxo association is immediately made.

So, what can a bunch of US attorneys do to bring this old Brummie out of retirement. Well, judging by the media coverage, not a lot. In fact, since this story broke on the subscription based Law360, none, not one, of the major news outlets have reported on it. Don't you find that strange?

Oh, I almost forgot. Here's the background.

General Motors (GM) defended a lawsuit brought against them by the parents of 29 year-old Brooke Melton who was killed whilst driving her 2005 Chevrolet Cobalt. Her parents had hired an engineering expert who found that it was an ignition switch flaw on the 2005 Chevrolet Cobalt that Melton was driving. The lawsuit was settled and General Motors went on to recall 2.6 million vehicles.

The Melton's settled with GM in September 2013. GM recalled 2.6 million vehicles in 2014.

At first glance one would assume that GM were acting in good faith. Not so, apparently.

After settling with the Melton's, GM admitted that they knew about the flaw some 10 years prior to the recall. Hmm, now that's not playing ball, is it?

This startling revelation saw the Melton's file suit again in May 2014. They argued that GM should rescind their previous settlement ($5 million) because it mislead the Melton's about the total number of defects. GM had previously not acknowledged that Brooke Melton’s fatal crash was caused by the ignition switch defect.

Once again, GM settled with the Melton's for an undisclosed fee. They will retain the $5 million but will also receive a payout from the GM injury compensation fund.

So, where do King & Spalding come into it?

Well, earlier today the subscription based legal website, Law360, broke the news that not only did GM know about the flaw but attorneys representing them knew too.

Law360 writes...

"General Motors Co.'s emails with King & Spalding LLP and other outside counsel show the automaker engaged in a "massive cover-up" to hide its deadly ignition switch defect, the plaintiffs' attorney who unearthed the defect and documents said Monday."

The emails in question will now be used in federal MDL cases against GM. It is unknown whether or not these emails will ever be made public.

The article on Law360 can be accessed here.

You can follow King & Spalding on Twitter by clicking on the links below.


Related King & Spalding stories:

Ryan, Glaxo's Non-Viable Fetus - Part I

Ryan, Glaxo's Non-Viable Fetus - Part II - The Twists

Bob Fiddaman.

Monday, March 02, 2015

Update - No Other Man - Bob Fiddaman

Most will know that I have taken time out from all things Pharmafia to concentrate on writing a fictional novel. The whole writing/creating process has been therapeutic and I have now reached 40,000 words. It's nowhere near finished, most publishers these days are looking for a minimum of 80,000 words before they'd even consider reading a manuscript.

The story is not something that people would normally associate with Bob Fiddaman, the activist - this has been a challenge as I move away from GSK, death and birth defects.

I have created two strong characters so far (Don Williamson and Karen Crawford), the others I will build on over the coming months.

Don Williamson, a 50 year-old paralegal from the UK - he's recently been dumped by his girlfriend, Katy Johansson, 35, who lives in Östermalm, a large wealthy district in central Stockholm.

Karen Crawford, 40, is a famous American Model living in the UK. She hides a secret from her past, a secret that is very much part of the plot that centres around a poem penned by Don Williamson, some 13 years ago, in 2001.

Angie Jakobs, 41, a famous American TV psychic who is Karen Crawford's best friend. Angie lives in Sun Valley, Idaho, just two miles away from Karen Crawford's second home, a $6 million 1,000 acre ranch.

Lex Brampton, 43, lives in Pocatello, Idaho. For the past 17 years or so Brampton has kept an unhealthy interest in Karen Crawford. He was sent to a juvenile correctional facility at the age of 16, then, at 18, he saw out his sentence in a Lubbock correctional facility.

In 2001, after his wife told him she was having an affair and was moving out to live with Dan Pallet, Don Williamson turned to the stars in the night sky for comfort. Whilst looking at the stars a poem came to him. The poem contained a hidden code, only Don Williamson never knew it. The code would be broken on New Year's Eve 2014. It's a code that newly elected Pope John III has taken an avid interest in, only he does not know the whereabouts or content of the poem, only its existence.

Don and Karen are guided on their journey by angels, who in turn, are given daily instructions by Archangel Gabriel. Don and Karen's journey has been planned from their birth and it all comes to fruition as 2014 changes to 2015.

The plot (beginning, middle and end) was written over 6 nights, roughly 20,000 words. Since then I have revisited the manuscript and created a further 20,000 words. I hope to increase it over the coming months.

It's a story that has many twists and turns and one that is primarily about love, light and truth. The message, I guess, is to treat others as you wish to be treated and also to be aware of the signs around us that angels are leaving us.

The book is called 'No Other Man' and I hope to have it completed around September.

Bob Fiddaman.

Sunday, February 22, 2015

Shane 22nd February

Today marks the birthday of Shane Clancy. He would have been 28

Shane is yet another victim who fell foul of antidepressants. Sadly, another young man also became entangled in the adverse side effects caused by the citalopram (known as Celexa in US) Shane was taking.

Here's a podcast I did with Shane's mom, Leonie, back in 2011. Interview starts at the 5 minute 30 second mark.

Bob Fiddaman.

Friday, February 20, 2015

Matthew - 21 February 2009

**I'm posting this Friday 20 Feb because of more internet traffic - this is a story that needs to reach far and wide.**

There will always be those of us who just don't fully comprehend the grief. A small part of me feels your pain but a bigger part of me, call it my spiritual side, feels gratefully enriched for being allowed into Matthew's life. Thank you Amery and Christiane for allowing that to happen.

God speed little man.

Bob Fiddaman.

Monday, January 19, 2015

Saying Goodbye

I created this blog way back in April 2006. Initially I had a gripe with the British drug regulator, the MHRA.

I was concerned because I had suffered at the hands of GlaxoSmithKline's Seroxat, known as Paxil in the US.

Over the last nine years or so I've had an online stalker who, along with his internet acquaintance, stalked me and impersonated me online, at times targeting the parents of the victims that I had wrote about.

I've been threatened with legal action by one of GlaxoSmithKline's former employees (he was employed by them at the time)

I've met with the British drug regulator on numerous occasions, those meetings turned out to be as useful as a chocolate teapot.

I've met some wonderful people on my journey, even had intimate relationships with two of those I met, one of which, I regret.

In the main, I've covered many stories about children/teenagers who have succumbed to antidepressant use. I hope I have brought their parents some peace and satisfaction with my efforts. I hope I have drawn awareness to the dangers of these mind-numbing drugs that have, for many, caused nothing but heartache.

I've been fighting almost alone for nearly nine years with the blog work, dealing with other's grief, emptiness, and sadness. It's come to a point where it has just consumed me and, to be honest, I have to change things in my life after suffering a recent loss of my own.

It's hard to put my finger on any one story I've covered on this blog. Sara Carlin springs to mind. Through her death I met two wonderful friends in Neil and Rhonda - I hope to meet them again one day.

I was immensely proud to be presented two human rights awards from the Citizen's Commission on Human Rights (CCHR), one being presented to me in the US and one here in the UK. The CCHR introduced me to some wonderful people, many of whom still keep in touch with me via social media websites.

I was also very proud when this old blog of mine went over one million visits, a quick look now shows the counter at 1,189,171. Not bad for a Brummie who was expelled from school and told, "You will never make anything of yourself Fiddaman."

I had always dreamed of seeing my name on the front cover of a book - I achieved that too with my book, 'The evidence, however, is clear: The Seroxat scandal'.

During the past nine years I've seen new blogs appear... and then disappear. It's a tough game this blogging lark, kinda takes it out of you when you are the one that people turn to because they are addicted to antidepressants or they have lost a child to antidepressants or even given birth to a child with deformities due to antidepressants. It can be a very dark, lonely place when you take on stories such as these. They sit with you forever.

I'm pretty much running on an empty tank these days and am just bamboozled by the unkind acts and hardheartedness of some people.

To be honest, I'm exhausted by it all. I never ever thought that one of my foes would turn out to be the very same person who I tried to help by highlighting their plight on this blog, on numerous occasions. That toxicity for you folks!

I'm done with opening my email each day and seeing attachments hundreds of pages long and being asked, "have you seen this?"

I'm done with staying up until the early hours of the morning helping people find justice only to have them ignore me when my efforts found them the justice they craved (money)

I'm done with reading about GlaxoSmithKline making settlements to mothers who have had the misfortune of giving birth to children with serious defects. Done with it all.

During the last three weeks I've been to hell and back, I've still got a long way to go, I'm still struggling to come to terms with the whole 'gone in the blink of an eye'.

Deal with it I will, but I cannot continue being consumed by other people's lives, it's zapping my energy and causing bad vibes. I just need to get in sync with myself and start a new journey, one that doesn't involve the loss of loved ones. Losing someone you love is quite possibly the worst feeling in the world.

I started work on a new novel yesterday, it's been therapeutic. I don't know when it will be finished, don't even know how it will end but it's fiction and I can go pretty much anywhere I want with it.

It's called "No Other Man"

One day I hope to see it published.

For now, I'm saying goodbye.

I'll leave the last words for Sara...

Bob Fiddaman

Friday, January 16, 2015

Save the Children Respond Re GSK

Following on from my previous post 'Save the Children and GSK'

In my previous post I wrote about how I had wrote Save the Children and asked them the following regarding their partnership with GlaxoSmithKline.

As I am sure you are aware GSK recently pleaded guilty and were fined over $3 billion in the US for promoting drugs to children off-label. One of these drugs, Paxil, which goes by the brand name of Seroxat here in the UK, causes suicidal thinking in children. At the time of the off-label promotion GSK knew of this particular side effect but failed to inform medicine regulators and healthcare professionals. A result of which has saw children and teenagers go on to complete suicide.
My question to Save the Children is one of ethics.
Knowing that GSK promoted a drug that could harm children (and they (GSK) knew of the potential risk but failed to warn), do you (Save the Children) believe that a partnership with GSK is morally correct?
If you believe it is, please state your reasons.

Here is their response.

It's the first time I have ever seen an organisation, outside of the pharmaceutical industry, use the words 'benefit' and 'risk'.

I'm speechless.

We are aware of the reports on the historic issues relating to Paxil. As an organisation we take our role to protect children very seriously and assess all our partnerships and collaborations very much within this context. Save the Children works to ensure that decisions around who we partner with are made with the best interests of children at the core – and this means deciding whether the impact on children we can have through our programming and advocacy funded by a donor or partner outweighs any potential risks.
We consider carefully the risks associated with partnering with pharmaceutical companies and in the case of GSK our belief is that the risks are outweighed by the benefits of this partnership, in helping us achieve our ambitions for children. The focus of the GSK-Save the Children partnership is to help save a million children’s lives in the developing world.

Make of that what you will.

Save The Children can be emailed here.

Bob Fiddaman.

Wednesday, January 14, 2015

Save the Children and GSK

This is another of those posts that has taken a while to construct. My personal life took a kick in the gonads recently and I've been mulling over where I go from here. Do I continue down the path that I've been walking since the conception of this blog or do I change and write that fictional novel I've been meaning to write for some years now?**

Do I continue to answer emails from people who want my help or do I just give it all up and ignore them all? There's times when I feel deflated, none more so than this period in my life. It's a period where you truly find out who your close friends are and whether or not you are made of steel, as many think to seem bloggers who go up against the likes of GSK, are. Truth is, I'm just like you, I'm human. I feel pain and every single human emotion that others feel. There's some people who go through life seeking revenge, these people just cannot operate without feeling revenge, they spoil the life of others and see it as Karma, when in actual fact it serves only to make them feel better because their current lives are blighted by an inability to move on and let go of the past. Ironically, both individuals have suffered loss so know what it feels like, their goal, it appears, was to inflict that pain upon someone else by colluding together to throw a spanner in the works of something that was quite beautiful.

The whole experience has left me feeling somewhat broken, so both individuals should take a bow at this point - Job done. Ironically they both share the same letter in their first names. They know who they are - I just hope now that they feel a sense of satisfaction and are able to move on with their lives, just as I am trying to do... I digress.

Corresponding with Save the Children has been difficult but it's kept me focused on what needs to be done (in this instance anyhow). Both they and GSK have been working together since 2005 on a number of public health projects, including GSK’s initiative to reinvest 20% of the profits it makes in least-developed-countries back into community programmes to strengthen healthcare infrastructure, primarily through the training of community health workers. Their current partnership, to help save the lives of one million children, builds on this existing partnership and will help them achieve their ambitions for children.

You can see my dilemma here. On one hand I applaud the efforts of Save the Children for taking measures to help children, on the other I feel that partnering with GSK is morally wrong.

In an email to Save the Children I asked if it were GSK who approached them or if it was they who approached GSK.

Here's the reply...

Save the Children and GSK have actually been working together since 2005, which began with a community health and well-being programme called ‘PHASE’ – Personal Hygiene and Sanitation Education. Save the Children approached GSK to explore their potential support for our health programmes . Our global partnership with GSK was further developed and formalised in 2012, when the CEO of Save the Children was invited to speak as part of a GSK leadership conference. The discussions that took place at this event initiated the process to explore a more ambitious partnership between both organisations.

With this admission, I wrote back to Save the Children with the following...

As I am sure you are aware GSK recently pleaded guilty and were fined over $3 billion in the US for promoting drugs to children off-label. One of these drugs, Paxil, which goes by the brand name of Seroxat here in the UK, causes suicidal thinking in children. At the time of the off-label promotion GSK knew of this particular side effect but failed to inform medicine regulators and healthcare professionals. A result of which has saw children and teenagers go on to complete suicide.
My question to Save the Children is one of ethics.
Knowing that GSK promoted a drug that could harm children (and they (GSK) knew of the potential risk but failed to warn), do you (Save the Children) believe that a partnership with GSK is morally correct?
If you believe it is, please state your reasons.

I thought by asking them a direct question would, at the very least, tap in to their conscience, assuming they had one.

Stay tuned for their response.


To me, at least, it's about giving children a voice. This vulnerable population, at times, need someone to speak up on their behalf. I'm not, or have I ever, professed to be a martyr. When I see the likes of GSK teaming up with an organisation who have children's best interests at heart it makes my blood boil for two reasons.

1. GSK have an abhorrent history regarding Paxil and children.

2. Save the Children would have already done their homework yet chose the unmoral path.

The picture that accompanies this article reads, "Don't Believe Everything You Think" ~ a valuable parable when trying to make the correct choices in life. I'm at the stage of letting go of believing everything I think, to go down that path is destructive. Save the Children, on the other hand, have evidence that their partners, GSK, were up to no good... yet they still wish to remain partners.

I'll never quite understand relationships.

**For what it's worth, I'm going to continue writing, albeit with my foot off the gas for a while. I need to make changes in my life ~ writing a fictional novel is just the start of that change.

Bob Fiddaman.

Saturday, January 10, 2015

Key Expert To Give Evidence Against Zoloft (Birth Defects)

A group action seems to be in full flight against in the United States whereby hundreds of mothers are claiming that Zoloft (sold and marketed by Pfizer) caused birth defects in their children.

Initially U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania barred the testimony of the group's previous expert,Dr. Anick Bérard, citing several problems with her research.

Plaintiffs sought a new expert and Pfizer objected, claiming that plaintiffs had plenty of time to put in place a reliable expert and bringing a new one forward was merely down to Bérard's testimony being dismissed.

Judge Cynthia Rufe ruled in favour of the plaintiffs and they can now move ahead in their case against Pfizer where they allege that Zoloft (Sertraline) caused a number of heart defects in their children.

Pfizer remains confident that there is no reliable scientific evidence demonstrating that Zoloft causes the injuries alleged by the plaintiffs.

Full story here (subscription only)

Bob Fiddaman

Saturday, January 03, 2015

ADHD - Market Challenge - Unknown Etiology

A market report carried out by TechNavio analysts predict that the Global ADHD Drugs market will grow at a rate of 5.33 percent over the period 2013-2018.

The 80 page report, if you are financially well off, costs a staggering $2,500 to purchase. The report covers...

The present scenario and the growth prospects of the Global ADHD Drugs market for the period 2014-2018. To calculate the market size, the report considers the revenue generated from the sales of various therapies used in the treatment of ADHD, which include:
TechNavio's report, the Global ADHD Drugs Market 2014-2018, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the Americas, and the EMEA and APAC regions; it also covers the Global ADHD Drugs market landscape and its growth prospects in the coming years. The report also includes a discussion of the key vendors operating in this market.

Interestingly, one of the main market challenges the report found was...wait for it... are you ready yet?

Unknown Etiology

In other words, those manufacturing the drugs to treat ADHD don't actually know the causes of ADHD.

To combat this (small flaw) the Pharmafia (that's pharmaceutical companies and medicine regulators combined) will use various marketing strategies to say how bad ADHD can be if not treated... and actually skip the fact that they, themselves, do not know the etiology of it.

The report suggests that the Pharmafia must "increase the awareness" so expect a lot of pseudo-science over the coming years folks.

Drugs discussed in the report include Strattera, Concerta/Ritalin, Focalin, Intuniv and Vyvanse/Elvanse/ Venvanse.

The key vendors, according to the report, are Eli Lilly, Janssen, Novartis and Shire.

Between now and 2018 it appears that the goal is to not only target children who have a brain disease but adults too.

A brief abstract of the report reads...

ADHD is a psychiatric disorder, which is mostly found in children. However, adults have also been reported to be diagnosed with ADHD. The patients with ADHD suffer from several problems including hyperactivity, impulsiveness, and lack of focus and concentration. The causes of ADHD are not known. It is believed to be linked with genetic and environmental causes. However, it has been reported to be related with the decrease in the extraneuronal levels of norepinephrine and dopamine. In addition, the patients have an abnormality in the brain structure. It is more prevalent in boys than girls. The management of ADHD is done by counseling, medications, and lifestyle changes.

Notice how the causes of ADHD are played down and followed with the standard Pharmafia scaremongering line... "It is believed to be linked with genetic and environmental causes. However, it has been reported to be related with the decrease in the extraneuronal levels of norepinephrine and dopamine. In addition, the patients have an abnormality in the brain structure."

What you, as a prospective consumer, need to take from this are two key words...

1. Believed
2. Reported

In other words, the Pharmafia "believe" in a theory because it, coincidentally, means they will be able to treat a population based on this theory.

It has been "reported" basically means that the Pharmafia have cherry-picked reports, once again to suit their own agenda (selling drugs)

They did this with SSRi's when they were first launched. Back then we were told that SSRi's such as Prozac and Paxil could correct a chemical imbalance... (the cause of the anxiety and depression we were feeling)

When this theory was proven to be incorrect one would have thought that trading standards would have slammed the Pharmafia for selling products on a lie. However, the Pharmafia still had the luxury of tweaking their wording.

Look at any SSRi on the market today and you will see a key line...

"It is thought"

So, "it is thought" that anxiety and depression are caused by a chemical imbalance. It still gives us the message that they are right and we have something abnormal with us.

And that's exactly how they want it to remain folks.

If you want an alternative treatment for your child then read Psychiatric Medication or Play Therapy?

If you are an adult who has been diagnosed with ADHD and, as a result, you have been offered medication to control it then... well, you are grown up enough to know that the Pharmafia just want your money and want you hooked on their wares.

Some of the side effects of the drugs mentioned in the report are pretty severe - Pharmafia will play those down too.

In a nutshell, before you decide to go down the road of drugging yourself...or your children, do your homework.

Don't believe me? When diagnosed answer your doctor with a two-worded question and watch his face.

The 40 second video perfectly shows this.

Bob Fiddaman.

Wednesday, December 24, 2014

Where Are They Now? - Dr Alastair Benbow

Alastair Benbow was once GlaxoSmithKline's mouthpiece when it came to defending the safety (and efficacy) of Seroxat (known as Paxil in the US) - but where is he now?

Benbow is now Chief Medical Officer and Head of Operational Services at Kinapse, an expert advisory, capability building and operational services to the world’s leading life sciences organisations.

Benbow's role, according to his profile page on the Kinapse website, is to be accountable to the CEO and Board of Kinapse for the integrity and effectiveness of Kinapse’s system for medical governance. His role as Head of Operational Services covers Kinapse Regulatory, Medical Writing and Information, Clinical Trial Disclosure and Pharmacovigilance functions.

Have you finished laughing yet?

Apologies if you have choked on your cornflakes.

Responsible for  Clinical Trial Disclosure, Pharmacovigilance and Medical Writing?

Other employees of Kinapse include:

Head of Strategy - Suzanne Budsworth
Senior Pharmacovigilance Scientist - James Whitehead
Regulatory Associate - Kapil Pal
Senior Manager, Regulatory Affairs - Stuart Goodall

All are previous employees of GlaxoSmithKline.

Former Management Consultant at Kinapse, Stephen Mayhew, is now Head, R&D Strategy Development and Programme Management Office at GlaxoSmithKline.

Revolving door anyone?

Benbow is infamous (whether he likes it or not) for defending Seroxat and playing down the suicide link and other side effects associated with it.

He also took umbrage to a video slide-show I created about him back in 2008 [Seroxat Secrets]

Here's part of a transcript featuring Benbow and BBC investigative journalist, Shelley Jofre. Much of what is transcribed here never went to air.


Q = Jofre
A = Benbow

Transcript GSK Tape - Panorama Interview - Dr Alastair Benbow 9 October 2002

Q. Let us move on. What has the company done about the Wyoming verdict?

A. As I told you before, in this matter because of a confidentiality agreement between the family and GSK I am not able to specifically comment on the mitigation, but what I can say is that there is no reliable clinical evidence that Seroxat causes violence, aggression or homicide. This tragic, tragic case is something that does occur from time to time in patients who are depressed...

Q. This man had no history of suicidal thoughts or tendencies. The jurors sat and listened to all the evidence and decided that there were four deaths that were mainly caused by Seroxat. Your company was found guilty of negligence. You cannot ignore that.

A. No, and nor would we want to ignore it. This was a tragic case but we remain firmly convinced that Seroxat did not cause the tragic events in this case.

Q. So the jurors got it wrong!

A. No, I am not saying that. What I am saying - as I have said before - is that there is a confidentiality agreement between the family and GSK in this matter and I cannot comment on the specifics of this but we remain firmly convinced that Seroxat did not cause the tragic events in this case.

Q. It was pretty clear-cut. There was nothing else to explain his behaviour. He had only been on the drug two days and he clearly had a reaction that threw him into mental turmoil and made him behave in this way.

A. Yes, but there is a lot of speculation in the question you asked there but as I said I cannot comment specifically on this case because of a confidentiality agreement between the family and GSK. What I can say is that looking at all the data and the clinical trials there is no reliable evidence that Seroxat causes violence, aggression or homicide.

Q. All the evidence was produced in the trial. I am sure your company more or less produced the best evidence that was available. The jurors decided Seroxat was responsible for those four deaths and that is pretty serious.

A. As I have said before, I cannot comment on the specifics of the case...

Q. You cannot tell me that the clinical trials support Seroxat as not being linked to aggression or suicide?

A. Yes, I can say that. The clinical trial data and spontaneous adverse event data for reporting over the last ten years since Seroxat was made available in the UK do not support the finding that Seroxat causes aggression, violence or homicide.

Q. All of this data was presented to the jurors so they had ample opportunity to hear arguments on both sides and they felt Seroxat was responsible for the deaths.

A. As I say I cannot comment on the legal situation because of a confidentiality...

Q. I am not asking you to comment on the legal situation. I am asking you to comment on the fact that your company's drug was found responsible for four deaths.

A. As I said, I cannot comment on the specific situation but what I can say, quite clearly, is that when you look at the data from clinical trials and from the data in use in tens of millions of patients in 1999 that there is no reliable evidence that Seroxat causes violence, homicide or aggression.

Q. Is your company just going to ignore this verdict as if it never happened?

A. No we take very seriously any event that occurs when patients are taken off...

Q. What have you done to make sure that this does not happen again?

A. We have looked very, very carefully at the data, and as I say the data clearly shows that there is no reliable evidence that Seroxat causes violence, aggression or homicide.

Q. What does the warning in the patient leaflet mean then?

A. What do you mean?

Q. The warning about self-harm and suicide that is on the Seroxat leaflet, what does it mean?

A. As you will know, in patients who are depressed there is a significant risk of suicide and self-harm. That risk of suicide is at its worst when people have their worst depression, and that is often when people go to the doctor...

Q. Why would the risk of suicide increase once they start taking Seroxat?

A. No, I am not saying it increases when they start to take Seroxat; I am saying people are at risk of suicide early in treatment because it takes a while for an anti-depressant to work.

Q. The suggestion in the warning is that there is an increased risk in the first few weeks of being on Seroxat, but you say it is nothing to do with your drug?

A. What I am saying is that there is an increased risk of suicide early in the treatment of depression. Whatever the treatment, or indeed if there is no treatment there is an increased risk of suicide, and this is a very...

Q. So it is just a co-incidence that the increased risk of suicide starts when they start taking Seroxat?

A. No, what I am saying is that there is an increased risk of suicide even if patients receive no therapy. This is a fact of people who have depression. The reality is that many people with a severe depression have a very low mood and loss of energy. As people start to recover their energy and mood encourages...

Q. But they are not recovering, you say, until a few weeks after they start the Seroxat.

A. Early on in treatment the major affects of anti-depressants take a week or two to start, but the reality is that energy levels are one of the first things that start to improve, but mood comes later.

Q. Is it not that they get agitated?

A. Not at all. Not at all.

Q. It sounds to me here as though you are trying to have it both ways. You are trying to say the risk increases when you start taking the drug but it is nothing to do with the drug. It is meaningless warning.

A. No the warning is there, and has been agreed with the regulatory authorities, and it is basically to tell doctors, 'Look, you have a patient who is depressed. They are at risk of suicide. Don't just think just because you have started them on anti-depressants that they are not going to remain at risk of suicide immediately. The fact is that antidepressants take a while to work. If you look at the data what does the data show? The data shows that Seroxat reduces suicidal ?hydration and thought. Over the past ten years - or the ten years between 1990 and 2000 - with the increasing use of antidepressants, suicide rates in England and Wales have fallen by 15%...

Q. Are you taking credit for that?

A. I am saying that the increased used of anti-depressants, the better diagnosis of depression and the better treatment that is available - yes, that has contributed to the fall in suicide rates.

Q. Perhaps over the long term drugs like Seroxat are useful for avoiding suicide and reducing suicide rates but what we are talking about is a window in the first few weeks where there is quite a lot of evidence that people can become agitated, restless and anxious. It seems to correspond exactly with the period that you are saying there might be an increased risk of suicide but you are saying it is nothing to do with your drug.

A. No, I must disagree with the comments you made. There is not a lot of evidence to suggest that patients are getting agitated and restless and anxious. The reality is that anti-depressants do take a short while to work, and during that first few weeks, when patients are taking therapy, doctors should be aware that patients are at risk of suicide, because of their underlying depression.

Q. So it is not an increased risk. I do not understand what you are saying. If you are saying, 'Until the anti-depressant starts working they are at the same risk of suicide as they have always been' then that is one thing. However, your warning says there is an increased risk of suicide...

A. What I am saying is the greatest risk to patients of committing suicide is in those who are severely depressed.

Q. But in those first few weeks of... [talking simultaneously] start Seroxat?

A. No, the most severely depressed patients are those that have just presented their doctor and just started on therapy.

Q. Of course not everyone take Seroxat for depression and we have spoken to someone who took Seroxat for panic attacks and he began to self-harm in the first few weeks of taking it, something he had never even dreamed of doing before.

A. Seroxat is indeed available for a range of depression and anxiety related disorders, all have clear criteria for laying down exactly what the conditions are. There is a range of different conditions - panic disorder, obsessive-compulsive disorder, social anxiety disorder etc. Many of them are associated with depression and the same patients will be at risk of suicide and...

Q. Again is it just a coincidence this behaviour would start a few weeks after taking Seroxat?

A. No I am not saying it is a coincidence. I am saying it is a reality of depression and other related disorders...

Q. Panic attacks?

A. Yes, panic attacks and...

Q. I thought that is a link to self-harm.

A. Panic attacks are linked to depression, which is linked to self-harm.

**At this point Jofre pushes home the point about Seroxat withdrawal - She then continues with...

Q. Well, let us move on. Here is a drug that is linked to suicide and self-harm, a drug that thousands of people say they are addicted to; do you seriously think it should be given to children?

A. Let me just correct something in your question. There are a number of allegations you made there none of which are correct. In terms of whether we think Seroxat should be made available to children, absolutely. Two percent of children, 4% of adolescents, will develop depression. The adolescents are at particular risk of suicide.

Q. You think this is safe for children?

A. I think we need to do the trials to determine this. We have an obligation to make our medicines available to those patients at need. Adolescents are some of the patients who are most at need of anti-depressants. Suicide in adolescents is the third leading cause of death. Do not trivialise depression for those patients. We have a strong obligation to study our medicine in these patients to see if we can help them.

Q. In a recent study that Glaxo funded more than 10% of children developed psychiatric problems within eight weeks of taking Seroxat.

A. I think you will have to tell me a little more about the specific study so that I can understand your question.

Q. It was funded by Glaxo and carried out in America - the biggest ever study of Paxil in depressed children and more than 10% of children developed psychiatric problems within a few weeks of taking Seroxat.

A. I think in any study a proportion of patients (as in this particular study) where patients were either taking Seroxat, or Imipramine, or a placebo, a proportion of patients will develop adverse effects in the course of the study.

Q. There were far more children on Seroxat than on the other drug, or on sugar pills who developed these psychiatric problems.

A. There are a number of different elements that you lump together in psychiatric disorders.

Q. I will run through the list of problems if you like. Five of the children suffered suicidal thoughts and gestures. There was aggressiveness. There were behavioural problems at school. None of this sounds very safe; it all sounds quite worrying for the children who are on Seroxat.

A. Actually not because some of those symptoms were also seen on the patients taking Imipramine and placebos.

Q. Not as frequently.

A. Maybe not as frequently, but they still suffered. This is typical of the sort of symptoms that occur in this population of patients. This is a difficult population to treat and you will be aware that for many medicines there is no licensed implication for use in children so much of prescribing in children is done off-label. We firmly believe that we have an obligation to study our medicine to treat population to examine the safety and the efficacy of that medicine.

Q. I appreciate that but there were many problems on Seroxat than on the other drug or the sugar pills.

A. Actually the majority of those side effects were relatively minor.

Q. No, a lot of these children were hospitalised it was so serious.

A. If you look at the proportion of patients who withdrew from therapy - and you can see less than 10% had to withdraw from Seroxat - more than 30% withdrew from the other active therapy and just under 10% withdrew from the dummy.

Q. It is heart complaints with the other drug, and I understand that, but-

A. But that is the sort of therapy that is the alternative, which is why it is very important that we study Seroxat in this group of children who are most at risk from suicide.

Q. What we are talking about here though are psychiatric side effects, the sorts of side effects that can lead to suicide and there were far more children on Seroxat suffering these problems than on the other drug or sugar pills.

A. What you are trying to do is make a link here with the adult data. The adult data clearly shows that there is no reliable scientific evidence that Seroxat causes suicide.

Q. But why should it be that so many more children should suffer these side effects on Seroxat than the other drug or sugar pills.

A. Actually, if you look at the more serious of those side effects the number difference was very small, and the sort that you would expect to see in clinical trials. On one trial there may be more than on another, in another it will go the other way.

Q. And for the 10% of the children on Seroxat who had these side effects you are not worried that it was caused by the drug?

A. The vast majority of these patients did not have side effects significantly enough to withdraw from the treatment. The reality is that in this population depression is an extremely serious condition and in many cases leads to suicide.

Q. I appreciate that.

A. Are we worried by the side effect profile? We take the safety of our medicines extremely seriously and we will look very carefully at this, and the combination of other data, to decide whether this medicine is suitable for children. My belief is that it will be but because there is a lack of treatment for this serious condition that this medicine will be suitable for a range of children as well as adults.

Q. You cannot be sure that the 10% of children on Seroxat who suffered these problems did not suffer them because of Seroxat can you? You cannot be sure about that.

A. One can never be sure of anything in medicine, but just because you take a medicine and you get an effect does not mean to say cause and effect because the same sort of symptoms occur with the dummy pills.

Q. That is why if you compare it to another drug and the sugar pills, in that comparison Seroxat was much worse.

A. In that comparison the proportion of patients withdrawing from the study due to adverse events was much lower on Seroxat than one of the other potential treatments available.

Q. There are 60 psychiatric side effects - the sorts of side effects that are linked with suicide and self-harm.

A. Let us look at the totality of the adverse event profile because it is the total risk and input that is important.

Q. We are considering the link with suicide, and this evidence points very strongly to the fact that more children are suicidal and had suicidal gestures in fact on Seroxat than the other drug.

A. With respect the totality of the data is important. What you are talking about are five patients out of the 275 on Seroxat, three patients on Imipramine. That difference is not significant and one patient had a placebo.

Q. No, I am talking about five children. The figures are-

A. I have given you the figures. Five on Seroxat, three on Imipramine and one on placebo.

Q. There were children out of 93 children on Seroxat who had suicidal thoughts and gestures, another five out that 93 had serious psychiatric side effects. Do you not think parents would be worried about that if their child were to be given this drug?

A. I believe that what parents would be more worried about is the risk that their children had of committing suicide and other symptoms of severe depression if no treatment was available. In my opinion parents want treatments to be properly evaluated during clinical trials before their children are given any medicine.

Q. But the evidence here suggests that their children might be at more risk of suicide if they go on Seroxat.

A. No, the evidence is not there. There is no statistical difference between the groups. The reality of the situation is that in this trial Seroxat was generally well tolerated by this difficult to treat population.

Q. You are not concerned about this and you do not think parents should be concerned about this?

A. What I am saying is that we are attempting to study Seroxat in this difficult to treat population. If, and when, we demonstrate the efficacy and the safety of the product, then the data will be submitted to the regulatory authorities with a view to getting a licence so that these patients and their doctors have another treatment available to them to treat this difficult disease.

Q. You would like it to be licensed for children?

A. Of course it must be driven by the data. There are many times we do clinical trials where you find that the balance of risk and benefit is not capable, in which case you do not try and get a license. The reality in this situation is the data we have generated so far is favourable. There is more benefit than risk in this population but until we have developed all the clinical trials, and done a full package of information, and adequately studied this drug in this population we cannot say that.

Q. Are you satisfied then that your company, generally, has done everything it can to keep patients properly informed about the negative side of the drug?

A. Absolutely, and it is not something we just sit and watch. Our summary of product characteristics is a living document. You start with a very limited number of healthy volunteers. Then you develop the clinical trials in thousands of patients. Then you make it available to tens of millions of patients around the world. As time moves on you collect more information and more data becomes available, and as a result we regularly change the information, which we provide to prescribers and patients for all our medicines, and of course for Seroxat as well. We will continue to do that. We will continue to monitor the safety of our medicines. We will make changes to the information to prescribers and patients, driven by facts and data not by anecdote.

Interview ends.

Here's some brief segments of Benbow in action. The other 'Alasdair' in this short video is Alasdair Breckenridge. Both Breckenridge and Benbow are seen here defending Seroxat.

Breckenridge was the former Chairman of the British drug regulator, the MHRA. Before joining them he worked at GlaxoSmithKline.

Bob Fiddaman.