GSK Lawyers target Seroxat campaigner Bob Fiddaman – see the video they wanted banned!

Well, then… isn’t the internet a wonderful thing.

The video that Glaxo thought they’d had taken down can still be seen thanks to the magic of the internet!

You can read a full description of the contents of the video here…

… but perhaps you just want to go and watch it at Furious Seasons: Glaxo Goes After British Blogger’s Video.

Or maybe you prefer to watch it on YouTube…

Here’s what Phil Dawdy at Furious Seasons has to say on the matter:

I learned yesterday that attorneys representing GlaxoSmithKline in the UK had sent a letter to Bob Fiddaman, who writes the Seroxat Sufferers blog. Seroxat is Paxil’s brand name in the UK. As a result of the letter, Fiddy felt compelled to remove a video he created and posted to his website in February. It’s not clear to me what specific legal action the lawyers threatened.

I linked to the video when it was originally posted in February since I felt it got at some of the issues that had just been aired in the British and American press concerning accusations that GSK had hidden suicidality data connected with the use of Paxil. The person making that accusation was none other than Harvard clinical psychiatry professor Joseph Glenmullen who had reviewed clinical trials data in connection with a California lawsuit. Fiddy’s video presented statements made by Alistair Benbow, a GSK UK official and medical doctor, concerning the drug’s suicidality profile and contrasted them with statements in the British press about Seroxat’s suicidality profile as well as interspersing all of that with information about select patients who had experienced some of the drug’s rotten side effects. There was even background music.

Fiddy, in essence, posed the question of whether Benbow was a liar.

The whole thing seemed innocent enough since Fiddy was working with known facts and seemed to be presenting them in a reasonable fashion. But GSK’s attorneys, apparently writing to Fiddy on behalf of Benbow, objected to the fact that Fiddy had employed GSK’s logo in his video. What’s more, the video was posted to YouTube and in the comments section someone asked Fiddy a question and Fiddy compared Benbow with Hitler, as I understand it. The attorneys apparently complained to Fiddy that Benbow was feeling harassed as a result of the video. And they also took umbrage that Fiddy has implied that Benbow was a liar.

Fiddy explains his view of the situation here. He took the video off of YouTube recently and issued an apology to Benbow. Fiddy, most of you know, had some rotten experiences on Seroxat (Paxil).

Going after Fiddy for comparing Benbow to Hitler shows an incredibly thin skin on Benbow’s behalf and how silly British press laws are (the subject for another day perhaps). It’s also a move that Fiddy should regard as a backhanded compliment and a badge of honor. He’s being targeted because he is one of the loudest voices on the Internet denouncing GSK and how it’s handled Paxil/Seroxat and he’s clearly gotten under Benbow’s skin. Basically, GSK used lawyers to intimidate an activist into shutting up, especially in light of the fact that there are many, many others on the Internet who have talked serious trash about Benbow. Unless GSK plans to go after everyone who’s said anything sharp about Benbow, then they have singled out Fiddy.

Beyond that, this kind of behavior on GSK’s part chaps my hide, as the saying goes, because GSK has had run ins with academics before and attempted to stifle their views. I simply won’t tolerate this sort of nonsense and since I have obtained a copy of the video thanks to the magic of the Internet, I am posting it here, unedited.

The video is also on YouTube here. You can comment on it here or on YouTube. I know that Paxil/Seroxat stirs passions like few other psych meds, so I’d simply ask that people who feel compelled to comment on this matter in any fashion keep their rhetoric reasonably decent.

Learn more about Benbow here:

Seroxat increases suicidal thinking – it’s official – 2: Alastair Benbow weighs in

Panorama interactive forums

Benbow – “Science, not hype, will be the king here…

Alastair Benbow and the General Medical Council – are the GMC protecting Benbow?

GSK Lawyers target Seroxat campaigner Bob Fiddaman

I’ve just seen a new post at Seroxat Sufferers

It seems Glaxo are leaning on Bob Fiddaman as a video he posted on YouTube caused Alastair Benbow “serious distress by such unwarranted harassment”.

I understand Bob has removed the video – you can read a detailed description below of what it contained… and make your own mind up.

What I want to Know is who is going to speak out for ME against Alastair Benbow? I have watched him on TV and the internet and read his various comments about Seroxat – Benbow causes me serious distress every time he talks about Seroxat. In my opinion (and because of my experience of taking Seroxat and becoming addicted to it) Benbow simply does not know what he is talking about.

Is he lying?

Does he know the truth?

Rather than take damaged patients on in court, GlaxoSmithKline would do better to meet them and begin to try to understand why some people suffered Seroxat addiction and then undertake some meaningful research into the problem: there is something wrong with Seroxat and it causes problems for many patients.

But that’s not the Glaxo way, is it. This puts me in mind of the way Glaxo intimidated Dr John Buse when he spoke out against Avandia.

Here’s the post from Seroxat Sufferers:

The following is a message to my readers and also a statement from me that is, in the main, addressed to GlaxoSmithKline’s Lawyers, Addleshaw & Goddard and Dr Alistair Benbow, Head of European clinical psychiatry at GSK.

I have emailed Addleshaw & Goddard via their website with the following:

With reference to the letter you sent to Hugh James Solicitors regarding the posting and comment of your client GSK.

I have prepared and posted a statement and apology and would be grateful if Addleshaw and Goddard could confirm in writing within 7 days of receipt of yourselves and Dr Benbow reading the statement.

The statement can be read here:http://fiddaman.blogspot.com/2008/03/gsk-lawyers-target-seroxat-campaigner.html

I will understand Dr Benbow’s failure to respond to an apology given in good faith as churlish and provocative, and will prepare myself accordingly.

Yours sincerely
Mr Robert Fiddaman

—-


Well readers, it seems I’ve been singled out for creating a video regarding Seroxat

GlaxoSmithKline’s Lawyers, Addleshaw & Goddard, have wrote to the solicitors handling the Seroxat litigation because their client (GSK) were not happy with the content of a video posted on youtube entitled ‘GSK – Not So Corporate Video’. Their client were also unhappy with a comment left regarding Alistair Benbow.

Quite why they have contacted solicitors handling the UK Seroxat litigation rather than contact me direct is baffling.

The video in question has been removed from youtube, it was a choice I made not because of the content, which in the main, was quotes from Alistair Benbow balanced out with quotes from the media that are easily accessible on the world-wide-web. The decison to remove it was made basically because it seemed I had used their logo and photo without their permission.

According to the letter sent to my solicitors Alistair Benbow is said have been caused ‘serious distress by such unwarranted harassment’.

It is my belief that the video showed two sides to the Seroxat argument, however Addleshaw & Goddard think differently, they believe it was made to appear as if Benbow was lying. Could it not be argued that it was made to show that the media reports were lying? I’m just throwing the debate open here you see.

The video itself started off with the GSK logo then the GSK statement:

“We have a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better and live longer”

The next slide in the video read thus:

“GlaxoSmithKline knew even before Seroxat was approved that its drug could induce suicidality, dependency and withdrawal”

I don’t think there is anything defamatory within that statement as the MHRA have just proved that with their findings into their 4 year investigation into GSK haven’t they?

Or am I wrong?

The video continued with photos of Alistair Benbow followed by quotes he has made, the first being this one:

“The side effects (of Seroxat discontinuance) are things like dizziness, nausea, headache…”

This quote was followed by a paragraph taken from The Guardian:

“Britain’s best selling antidepressant, Seroxat, can cause adults as well as children to become suicidal”

The next slide in the video showed a photo of Benbow followed by another of his quotes:

“We take the safety of our medicines extremely seriously”

Once again Alistair Benbow’s quote is balanced out with another segment from The Guardian, this time:

“Glaxo played down Seroxat side effects”

Basically the video was showing the two arguments.

Yet again the Guardian quote is followed by one of Benbow:

“These medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm”

To balance things out the next slide in the video was a segment from the BBC news:

“Drugs giant GlaxoSmithKline knew that the anti-depressant Seroxat could not be proved to work on children in 1998, according to a leaked internal document.”

Once again I chose to counteract this statement with one from Benbow, as was seen in the next slide from the video:

“The information in the patient information leaflet and in the information we supply to doctors, is based on fact”

The following segment of the video was taken from the newspaper, The Argus, it reads:

“Happy pill girl’s suicide tragedy… A brilliant young artist killed herself after taking the controversial anti-depressant Seroxat”

A photo of Sharise Gatchell followed, I’d previously asked the mother of Sharise if I could use the photo.

The video continued with:

“Sharise had hanged herself. A packet of Seroxat, with 30 empty blisters, was lying on her bed”

The video then threw up another Benbow quote (purely as a way of balance)

“I utterly refute any allegations we are sitting on data, that (we) have withheld data or anything like that”

(Has the MHRA investigation just proved that statement to be incorrect?)

Or am I wrong?

The video then went into scroll mode and highlighted Paxil Study 329, more of which can be read here.

Again I allowed for balance by providing in the next segment another Benbow quote:

“I think patients have nothing to fear from taking Seroxat”

To counteract the above statement by Benbow I quoted a segment of a story taken from USA Today. It referred to a federal judge who had ordered GlaxoSmithkline to stop all television commercials nationwide that say the drug is NOT habit forming.

As was the pattern of the video I then opted to add another Benbow statement:

“Anybody who suffers side effects of any sort I feel every sympathy for”

The Daily Mail was my next source to use a quote from:

“Man slashed wrists on Seroxat. A coroner has called for Britain’s biggest selling antidepressant to be withdrawn after a retired headmaster who was prescribed the drug was found dead with slashed wrists”

The video then highlighted the story of 3 year old Manie from the USA, once again I asked permission to use the photos prior to the video being made.

Manie’s story can be read in detail here.

The video ended with the GSK logo.

In hindsight I would not have used the logo and to be fair I think the video was in the main a cross examination of both parties. The sufferers being represented by media reports and GSK being defended by Alistair Benbow.

The comment left on youtube I guess could have been deemed defamatory, it was a personal comment basically labelling Alistair Benbow a liar. For that I apologise, it was however, a personal opinion of which there are literally thousands across the world-wide web regarding Dr Alistair Benbow

Addleshaw & Goddard Solicitors suggest that.. “the natural and ordainary meaning of the video and the posting (comment) is that Dr Benbow has lied,acted hypocritically and/or been guilty of a cover up in making statements about Seroxat which he knew to be untrue”

I utterly refute that allegation and as you can see from this post – the idea was to leave the viewer with the question… Is Dr Benbow a liar or not?

My personal opinion (because we’re still permitted to have opinions, in western “civilized” democracies, even though GSK and its lawyers would appear to prefer that this were not the case), is that Benbow is either lying or is an ignorant person (for not knowing what was being discussed within his own company, on a subject upon which he was supposed to be expert). The latter possibility would be one for his superiors to address, assuming that they deliberately left him in the dark. This is fair comment on a matter of public interest, and I will not be silenced by some lapdog or lickspittle that has forgotten what the Law means.

I am entitled to my fair and balanced opinion on a matter of public interest by dint of the protection of the public interest privilege extended to the general public under the decision in Steel and Morris v UK, in the European Court of Justice. For the avoidance of any and all possible doubt, I reject utterly that my approach is malicious: I have nothing against Dr Benbow, though I find some of his utterances utterly incredible. Equally incredible is that a law originally designed to protect people from stalkers (The Harassment Act 1997) has been co-opted by these ‘professionals’ to protect Benbow from scrutiny.

Scrutiny now equates to harassment – I can’t see that that meets the definition in the Act, in any event. One piddling video ought not to be claimed to amount to harassment, and I can’t see that it does. I regret that he is reported to have claimed to have experienced distress – that was not the intention and I would apologize to Dr Benbow if the claim is true. However, until such time as he feels inclined to clarify whether or not he knew of the October, 1998 memo, I shall continue to speculate on the subject, lickspittles notwithstanding, because I see that question as key.

I suggest that this not-at-all veiled threat of legal action is viewed by myself as an attempt at intimidation on the part of GSK, which has prior form in this area (John Buse, etc). Naturally, I view this as utterly reprehensible if it wasn’t so transparent and unfounded, an abuse of its superior bargaining position, in terms of wealth, and so on.

I have insisted that Addleshaw & Goddard confirm, in writing, within seven days of receipt of this statement and apology to Benbow, that Benbow has accepted same.

I will understand Dr Benbow’s failure to respond to an apology given in good faith as churlish and provocative, and will prepare myself accordingly.

I will leave it up to my readers to decide whether or not they think Alistair Benbow is a liar and maybe revamp the video at a later date by removing the logo of GSK and the photograph of Alistair Benbow which apparently is the ownership of GSK. The rest of the video was basically two arguments.

There have been no physical threats made by me in this particular video and the reason Benbow’s quotes were used in the making of this video is that he has been the spokesperson of GlaxoSmithKline throughout thus making it impossible not to focus the subject matter on him.

I think it fair to say that I am not a great lover of GlaxoSmithKline because the drug they manufacture, Seroxat, has caused not only myself but thousands of others unwanted side effects. Is that statement defamatory? If so, then Addleshaw & Goddard may have their work cut out to prosecute the thousands of people that have signed and commented on petitions, blogs and websites here in the UK.

*On a footnote, this letter has made me feel intimidated and I feel the above statement from me is merely allowing myself freedom of expression and the right of reply.

The magnificent Alastair Benbow in full flow…

Seroxat comics once again – given the findings of the MHRA’s investigation into Glaxo they’re quite current once more:

Comic 1

Comic 2

Comic 3

I’m not sure which one I like best – it’s maybe a bit unfair to pick on poor Alastair Benbow quite so much because Breckenridge was just as useless when he was interviewed on Panorama.

OK – I’m sorry, I’ve had a chance to reconsider that last remark – I take it back. Pick on Benbow as much as you like, he deserves it!

You’ll remember that Benbow is the man, who, when asked on television by pharmacology expert Dr Andrew Herxheimer about why GSK had given no warning about the severe reactions from Seroxat despite knowing about it for 5 years… simply replied “Seroxat has provided countless benefits to many people and enabled them to do more, live longer and feel better… and I think that speaks for itself…”

That reply certainly does speak for itself – Glaxo’s corporate mission statement is “… enabling people to do more, feel better and live longer.” In fact, you can download GSK’s corporate brochure here – it’s entitled “Do more, feel better, live longer”.

Good to know we can rely on Dr Alastair Benbow to seriously address patient concerns about one of Glaxo’s drugs without even bothering to consider the direct question that had been asked.

Watch Benbow in action here and marvel at the way he continually avoids questions.

Please remember Alastair – it’s just a little bit of  fun!

Paxil/Seroxat – ‘information laundering’

This is from CL Psych’s excellent blog – a word for word lift as he’s done the job so well there’s nothing to add, except to note the fact that these people should be ashamed to have been exposed:

Joseph Glenmullen’s testimony regarding GlaxoSmithKline’s burial of suicide data related to Paxil, which was discussed briefly across the blogosphere last week (Pharmalot, Furious Seasons, for example), was quite interesting in many respects.

One important aspect that needs public airing is how key opinion leaders in psychiatry were used by GSK to help allay fears that Paxil might induce suicidal thoughts and/or behaviors. When GSK issues statements indicating that Paxil is not linked to increased suicide risk, many people will think “Gee, of course GSK will say Paxil is not linked to suicide – it’s their product, after all.” But when purportedly independent academic researchers make the same claims regarding the alleged safety of Paxil, then people tend to think “Well, if these big-name researchers say it’s safe, then I suppose that there’s no risk.” But what if GSK simply hands these big-name researchers (aka “key opinion leaders“) charts with data, and then the “independent” researchers go about stating that Paxil is safe? Mind you, the researchers in question don’t see the actual raw data – just tables handed to them from GSK – in other words, they simply take GSK’s word that the data is accurate. In essence, these researchers are serving as information conduits for GSK.

But wait a second, what if the charts and data tables handed to them by GSK are not an accurate representation of the raw data; what if GSK is lying? Well, of course, it turns out that GSK was lying in a big way for several years. This post will not go into depth on the suicide data, as it has been covered elsewhere (1, 2, 3 ) — even GSK now admits that Paxil is related to an increased risk of suicidality.

My main question in this post is how we are supposed to trust our “key opinion leaders” in psychiatry if they are willing to simply look at data tables from GSK (and others), then make pronouncements regarding the benefits and safety of medication without ever examining the raw data. To put this in layman’s terms, suppose an election occurs and candidate A wins 70% of votes while candidate B wins 30% of votes. As the vote counter, I then rig the results to say that candidate B won the election by a 55% to 45% margin. Suppose that the election certification board shows up later and I show them a spreadsheet that I created which backs up my 55% vote tally for candidate A. The election board is satisfied and walks away, not knowing that the vote counting was a sham. Obviously, the election board should have checked the ballots (the raw data) rather than simply examining the spreadsheet (the data table). In much the same way, these so-called thought leaders in psychiatry should have checked the raw data before issuing statements about Paxil.

What did these key opinion leaders say about Paxil? Some quotes from Glenmullen’s testimony follows, based upon documents he obtained in GSK’s archive. Here’s what David Dunner (University of Washington) and Geoffrey Dunbar (of GSK) reportedly said at a conference

“Suicides and suicide attempts occurred less frequently with Paxil than with either placebo or active controls.”

John Mann of Columbia University, regarding how data were collected:

“We spent quite a bit of time gathering data from various drug companies and formulating it into the publication of the committee’s findings.”

The committee he references is a committee from the American College of Neuropsychopharmacology, the same organization that issued a dubious report blessing the use of antidepressants in kids.

More from Mann, after being asked if he saw raw data or just data summarized in tables:

“To be perfectly honest, I can’t recall how much of the statistical raw data we received at the time that we put these numbers together…No, I think we all went through the tables of data that were provided at the time.”

To use the analogy from above, the election board did not actually see the ballots. Stuart Montgomery is next. He was an author, along with Dunner and Dunbar, on a paper in the journal European Neuropsychopharmacology that stated:

“Consistent reduction in suicides, attempted suicides, and suicidal thoughts, and protection against emergent suicidal thoughts suggest that Paxil has advantages in treating the potentially suicidal client.”

Did Dunner see any raw data?

Dunner: “I didn’t see the raw data in the case report forms. I did see the tables. I work with the tables. The tables came before any draft, as I recall. We — we created the paper from the tables.”

Attorney: “And — and you never questioned, did you, or did you not question the validity of the data in Table 8?”

Dunner: “No”

The above-mentioned paper that gave a clean slate to Paxil? According to a GSK document examined by Glenmullen, it was used by GSK to help convince physicians that they need not worry about Paxil inducing suicidality.

If you are an academic researcher, and you simply take data tables from drug companies then reproduce them in a report and/or publication, you are not doing research — you are laundering information. People think that you have closely examined the data, but you have not, and you are thus doing the public a disservice.

I am unaware of any of the above researchers ever issuing a public apology.

I can respect the context of the times; researchers may not have been aware of how pharmaceutical companies fool around with data in the early 90’s. So if anyone wants to issue a mea culpa, I’d respect such an apology, but I have a feeling that not a single one of the above named individuals (nor this guy) will make an apology. Instead, it will be more business as usual, as these key opinion leaders, knowing who butters their bread, will continue to launder information and tell the public that everything will be fine and dandy if they just take their Paxil, Seroquel, or whatever hot drug of the moment is burning up the sales charts.

Seroxat can be a killer – so says South Cumbria Coroner

SOUTH Cumbria coroner Ian Smith will contact drug authorities because he fears people are killing themselves after taking antidepressants.

Mr Smith is to write to the Committee on the Safety of Medicines – an independent advisory body on the quality and safety of medicines – following the inquest into the death of Nigel Woodburn.

Mr Woodburn drove into a tree just four days after being prescribed controversial antidepressants.

The retired bank manager, of Bardsea Green, was killed at the wheel of his car on June 16, minutes after confessing to his wife he’d had suicidal thoughts. He had been prescribed Citalopram after becoming depressed through ill health.

His heart-broken family said they were not aware of the suicide risks associated with antidepressants until the issue was highlighted at Mr Woodburn’s inquest this week.

Mr Smith told Tuesday’s inquest he knew of several other suspected suicides involving the same group of antidepressants, known as selective serotonin re-uptake inhibitors (SSRIs).

He said: “I have to say this is probably the fifth, if not sixth inquest I’ve heard within a period of three years when somebody either just going on to Citalopram or Seroxat, or coming off it, have killed themselves one way or another, totally out of the blue, totally without expectation, without a history of suicidal thoughts in the past.”

Mr Woodburn’s stepson, Gareth Salton, said: “I want people to understand the effects these drugs have.

“I want people to know it isn’t just something you read about in the national media.”

On the morning of his death, Mr Woodburn, 68, told his wife Rita he’d been thinking of killing himself.

“Even at that time I wasn’t unduly concerned,” she said.

“I didn’t think for a minute he was going to do anything silly.”

Mrs Woodburn went to ring her son, Gareth, and when she returned to the sitting room her husband had gone and the car was missing.

He travelled a short distance, in his pyjamas and dressing gown, along the A5087 coast road before crashing into a tree.

Collision investigator PC Philip Murray confirmed tyre tracks on the grass verge were consistent with rolling wheels, which indicates brakes weren’t applied.

Consultant histopathologist at Furness General Hospital, Dr Marek Witkowski, said the cause of death was a head injury.

Mr Woodburn had also suffered a ruptured aorta, which Dr Witkowski said raised questions about whether this caused the accident or happened upon impact.

Mr Smith said: “I think it is highly unlikely this man, who had just expressed for the first time in his life thoughts about suicide, should just by chance have had the ruptured aorta which caused the accident.”

Mr Smith returned a narrative verdict that Mr Woodburn died in a road vehicle collision.

He added: “I think what happened to Mr Woodburn was in part as a result of the drugs he was taking. There has been publicity about these drugs recently, particularly relating to younger adults, and it does seem to me it’s something that needs to highlighted.”

After the inquest, Mr Salton, 40, added: “I want people to know how awful these drugs are, and that when friends and family are put on these drugs to recognise what might happen, so they don’t go through the nine months of self-recrimination that this family has.”

Coroner’s officer Liz Gaskell stressed that anybody concerned about these antidepressants must consult their GP.

3 questions for JP Garnier… who, after all “has nothing to hide”

So then JP – you still have nothing to hide?

3 easy questions for you to start with then…

1
The MHRA wrote to you in early March asking for your consent to release a number of documents you provided them in the course of their criminal investigation into the company you run.

Have you given such such consent and if not why not? – after all, you have nothing to hide.

2
I notice that the MHRA tells us that during the course of the investigation, Glaxo and individual Glaxo employees declined “…invitations to attend interviews…”

Please name the individuals concerned and please tell me why they declined the invitation to attend interviews – after all, you have nothing to hide.

3
In February 2003 you alerted the MHRA, finally submitting some clinical trial data showing that paroxetine caused suicidal ideation, but even then data from adult and paediatric trials were merged.

Please explain why it took four and a half years to ‘alert’ the MHRA as this data was first analysed by Glaxo in October 1998 – after all, you have nothing to hide.

The British Psychological Society – who will investigate its professional misconduct?

In January 2007 was when I first wrote about Lisa Blakemore Brown – she was being prosecuted by the British Psychological Society (BPS) at the time regarding her alleged lack of fitness to practice psychology due to “paranoia”:

Commenting on tonight’s Panorama programme “Secrets of the Drug Trials” the editor in chief of the British Medical Journal, Fiona Godlee writes “Panorama’s account of GlaxoSmithKline’s successful attempts to market Seroxat for use in children, despite the fact that its own published trial found evidence of serious adverse effects and failed to show benefit, is fascinating but depressingly familiar. The Vioxx story, told last week (BMJ 20 January, p 120), appears to have all the same hallmarks, including the paying of opinion leaders and ghost writers to talk up a drug when the evidence can’t speak for itself.

But what about Doctors who don’t want to tow the Big Pharma line, or worse still, find themselves at odds with the medical establishment? Take the case of the psychologist Lisa Blakemore Brown, a specialist in Autism, ADHD & Aspergers. Blakemore Brown has been involved on the “wrong side” of the debate about the psychiatric disorder Munchausen syndrome by proxy (MSbP), maintaining that many parents have been falsely accused of injuring their children. There have been high-profile releases from jail of women such as Angela Canning. MSbP is a disorder in which an adult invents or deliberately creates a child’s illness to draw attention to themselves. She has challenged prominent doctors such as Sir Roy Meadows and Professor David Southall who, in her view, have promulgated a wholly inappropriate approach to scientific evidence. She has irritated pharmaceutical companies. But instead of debate Lisa has encountered its very opposite. The abuse of science goes right into the heart of a prominent professional body. Her colleagues have stood by in silence.

To learn more about this case, please go to Scientific Misconduct and read in detail what the celebrated whistleblower Dr. Aubrey Blumsohn and others have to say on this worrying case. This is about the distortion of scientific debate, most particularly by powerful forces in medicine. It is about the way in which industry, professional bodies, government regulators and powerful individuals collude to prevent scientific debate and to victimise those asking difficult questions. It is about the way those entrusted with authority behave.

Just the other day, over at Clinical Psychology and Psychiatry I noticed there has been an important development in the case as the BPS have written to Blakemore Brown:

“The Complaints Committee therefore found no evidence of professional misconduct on you [sic] part. The matter is now closed as regards to the Society.”

Read more about this over at Scientific Misconduct.

I presume that in a case like this the BPS will now be drafting an apology to Lisa Blakemore Brown and as they found no evidence of misconduct they will now be looking closely at the people and organisations who made the wild claims in the first place…

What do you think?

JP Garnier – “Glaxo has nothing to hide” …prove it then JP

Here is the letter from the Kent Woods at the MHRA to JP Garnier:

Dear Dr Garnier

I am writing to advise you that the Medicines and Healthcare products Regulatory Agency is today announcing the conclusion and outcome of its investigation into a number of allegations regarding GSK, in particular that the company withheld from the MHRA important clinical trial data relating to the safety and efficacy of Seroxat in children and adolescents, and promoted that product for use in this age group despite safety and efficacy concerns.

In immediate practical terms, the outcome of the investigation is that, having considered our investigation report, government lawyers have decided not to pursue a prosecution of GSK. Their view is that the law at the time these events took place did not require a pharmaceutical company to inform the regulator of clinical trials date in groups for whom the medicine was not licensed, and that there is insufficient evidence of GSK promoting the product for “off-label” use in under 18s. We will today be issuing a press release to confirm that, and will be publishing on our website a short report setting out the conduct and conclusions of the investigation. I am attaching both the press release and the report for your records.

This is the immediate practical outcome but there are a number of other issues arising from the process. There is obviously a need to tighten the law to make it absolutely clear that pharmaceutical companies have a legal responsibility to inform the regulator of any information that changes the benefit risk profile of their products, regardless of whether the information relates to a licensed indication. We will be using the current European Commission consultation on pharmacovigilance regulations and other opportunities to press for changes to the law in this area.

Such a course of action should be unnecessary in an industry which relies so heavily on public trust and aspires to high ethical standards. I would have thought it self-evident that such information should be made available promptly to the regulator in order that action can be taken to protect public health. However, that moral responsibility now needs to be insisted up by the unambiguous force of law.

You will be aware that we have reviewed a large quantity of documents from GSK. Legal provisions prevent us from releasing publicly any information gained under our statutory powers in the course of a criminal investigation. However, there has been a significant level of quite legitimate public interest in this case, and I would there like to release that information into the public domain. This of course requires your consent. GSK has regularly asserted that it has nothing to hide in this matter and so I should be grateful if you could confirm in writing your consent to the release.

Finally, I have no doubt that the content of this letter will be the subject of numerous Freedom of Information requests to the Agency in the coming weeks. The MHRA takes the view that any considerations of confidentiality are outweighed by the public interest in disclosure, and we will therefore be publishing this letter today alongside our investigation report.

If you have any queries about the contents of this letter, please do not hesitate to contact me.

I think it’ll be interesting to see how much information is released “into the the public domain.” 

It’s completely up to you Garnier – give your consent and prove to the world you really have nothing to hide. 

Glaxo’s spin on hidden Seroxat data scandal and Alastair Benbow’s memory loss between October 1998 and May 2003

Let’s take a step back, shall we.

It’s worth looking at what happened and when – because Alastair Benbow seems to have forgotten something…It was only in February 2003 that GSK finally submitted some clinical trial data to the MHRA showing that paroxetine caused suicidal ideation, and even then data from adult and paediatric trials were merged.

Full data from the clinical trials in children, demonstrating a causal link between paroxetine and suicidal ideation and behaviour, was finally submitted by GSK to the MHRA in May 2003 – a month before the company was due to submit an application for the drug to be licensed for use with children. [So Glaxo was still going to apply for a licence for use in children – in June 2003?]

GSK has rejected claims that it withheld information. Dr Alastair Benbow, medical director for GSK Europe, said: “We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour in patients under 18.”

So what Benbow is saying is that Glaxo did good – giving the MHRA, in May 2003, data from the trials and telling the MHRA there was a “potential risk”.

May 2003?

By my reckoning that’s four and a half years too late.

In October 1998 an internal, confidential SmithKline Beecham document about studies 329 and 377 was issued. Studies 329 and 377 tried to prove Seroxat/Paxil worked in children. In summary it said “… the data do not support a label claim for the treatment of Adolescent Depression… efficacy had not been demonstrated.” Specifically about Study 329 “…the study failed to demonstrate a statistically significant difference from placebo on the primary efficacy measures.”

In other words – it didn’t work.

About Study 377 we read “… failed demonstrate [sic] any separation of Seroxat/Paxil from placebo.”

In other words – it didn’t work.

“Data from these 2 studies are insufficiently robust to support a label change and will therefore not be submitted to the regulatory authorities.”

Feel free to download a copy of this document and read the rest of the interesting conclusions (especially page 6) – SB internal –

Now we move on to March 1999, to a fuller manuscript of Study 329 being prepared for publication. This was written by Sally K Laden but was attributed to Marty Keller, Neil Ryan and colleagues. (I believe this is what is known as ghostwriting).Please download a copy of this manuscript – Sally/Marty draft 3 -If you go page 4 you will see the conclusion reads “Paroxetine is a safe and effective treatment of major depressive disorder in the adolescent patient.”

You can see that Sally/Marty’s spin has quickly moved on from that of SmithKline Beecham only 5 months previously. In fact you might be forgiven for wondering how these two different conclusions could be reached from the same data…

Now on to March 2001 – internally at least SmithKline Beecham seem to have understood what the data from Study 329 really said. In an email to Cohn and Wolfe, the company said: “Originally we planned to do extensive media relations surrounding this study [329] until we viewed the results. essentially the study did not really show Paxil was effective in treating adolescent depression, which is not something we want to publicize.” Download a copy here – SB to Cohn Wolfe –

However, by August 2001 SmithKline Beecham Paxil Product Management was writing to all sales representatives selling paxil and telling them about Marty Keller’s “cutting edge, landmark study which was the first to compare efficacy of an SSRI and a TCA with placebo in the treatment of major depression in adolescents. Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression.” Download this memo here – Sales reps memo –

As I said none of this is new.

The last Panorama programme, Secrets of the Drug Trials was where all of this first broke.

Someone should have faced criminal charges.

So what do you say Alastair? – is four and a half years a timely response?

I wonder how many children and adolescents died in those four and a half years between October 1998 and May 2003 becuase they took Seroxat/Paxil?

You tell me.

This is how Glaxo hid data and fooled us all

Glaxo did hide data from the regulators and the public about Seroxat/Paxil – for those of you that are new to all this here’s what they did and how they did it:

Secret e-mails show that one of the world’s biggest drug companies distorted clinical trial results of their anti-depressant Seroxat, covering up a link with suicide in teenagers. On Monday January 29, 2007, the BBC TV programme Panorama showed shocking footage demonstrating how GlaxoSmithKline’s PR people and marketing department ‘spun’ devastating trial results on children which showed serious risk of suicide, self-harm and aggression (violence), and also indicated it was no more effective than a sugar pill. Instead they claimed to doctors that the drug was ‘remarkably’ safe and effective for under-18s, with the support of an ‘independent’ professor of psychiatry who earned $500,000 in fees from drug companies in one year.

Seroxat, marketed in the US as Paxil, an SSRI anti-depressant whose active ingredient is paroxetine, was a big success for GlaxoSmithKline (GSK) from its release in the 1990s, earning billions of dollars worldwide for the drug giant. With a strategy of creating new markets for the drug, in the mid-1990s GSK began to explore the possibility of obtaining a licence for its use in children (under-18s), and conducted clinical trials on groups of children to provide data proving its effectiveness which would support its application.

However, the trials were a bust, in particular Study 329, the biggest of a series carried out over a period of years in the US. The results of Study 329 demonstrated that Seroxat had no measurable benefit to child patients. As is usual in the so-called gold standard clinical trial approach, the drug was tested on one group while another was administered a placebo, a sugar pill with no active ingredient. Neither group, nor the administrators of the pills, knew which pill they were getting.

The group given the placebo performed just as well, or as badly, as those given Seroxat in terms of the trial designers’ criteria for improvement in their depression.

But the children who were given Seroxat suffered adverse reactions ranging from mild to serious. The serious adverse reactions included self-harm — mostly cutting; aggression — violence to others; and suicidality — suicidal thoughts or actions, meaning actual suicide attempts.

Seven out of the 93 children in the Seroxat group had to be hospitalised as a result. That’s almost eight per cent. To independent researchers, that would be a wildly unacceptable proportion of a treatment population.

In terms of risk, for example, a prevalence of an adverse drug reaction of one in one hundred, one per cent, or more is defined as ‘frequent’ and seen as unacceptable.

Yet Seroxat had put eight in one hundred in hospital in this clinical trial.

“This was the point at which GSK should have begun warning physicians who were prescribing the drug to children because not only is it not effective, it’s not safe,” says Karen Barth Menzies, the California lawyer heading the team pursuing a giant class action suit against GSK in America. Menzies possesses previously secret internal memos and e-mails from GSK, obtained as part of the disclosure process for the upcoming trial, which show what actually happened next.

The company dropped the plan to apply for a licence for the use of Seroxat in children. Its executives immediately recognised that the results of Study 329, which demonstrated no efficacy in treating adolescent depression, would ensure that no licence would be granted. In an internal company memo dated 14 October 1998, they concluded that the drug does not work and that a licence application would be refused: ‘The results of the study were disappointing. The possibility of obtaining a safety statement was considered, but rejected.’ The best they felt they could achieve was a ‘ statement that although safety data was reassuring, efficacy had not been demonstrated’.

‘Efficacy had not been demonstrated’ is a fancy way of saying that the drug did not work, and they knew it. ‘The possibility of obtaining a safety statement was considered, but rejected’ means they realised that the extent of adverse reactions in the trial, at 8%, meant the drug was not safe.

GSK marketing teams commented that ‘the data would be unacceptable commercially’. Panorama’s reporter Shelley Jofre translates this as ‘publishing the data in full would put profits at risk’.

Enter the spin doctors.

So the self-harm, aggression and suicide attempts were kept quiet, the lack of effectiveness filed away. PR people took over to implement a new plan: promote Seroxat to doctors as a treatment for under-18s.

How could this be? If it’s not been granted a licence, how can a drug be prescribed? Unfortunately, as Panorama explained, even if a drug is not licensed for a particular group doctors can still prescribe it if they think it will benefit their patient — so-called ‘off-label’ prescribing.

So GSK’s plan was simple — persuade doctors that Seroxat was indeed suitable for their child patients. Which they duly put into effect, spinning the exact opposite of what the studies had shown: Seroxat, they said, was ‘remarkably effective and safe for children’.

Enter the academic psychiatrists, notably Professor Martin Keller of America’s Brown University and child psychiatrist Dr Neal Ryan of the University of Pittsburgh, both co-authors of Study 329.

Panorama questions whether Keller is independent in any sense. The programme pointed out that in one year he earned $500,000 in fees from drug companies including GSK. Worse, it demonstrates that his paper on Study 329, published in the Journal of the American Academy of Child and Adolescent Psychiatry, which says it ranks as number one in child mental health in the world, ‘was written by a ghost writer who worked for a PR company, a PR company hired by GSK’. And it quoted an e-mail from Keller to the ghost writer, thanking him for his work: ‘You did a superb job with this. Thank you very much. It is excellent. Enclosed are some rather minor changes from me…’

The ghost had even penned Keller’s covering letter submitting the paper to medical journals.

Child psychiatrist Neal Ryan was paid by GSK as a co-author of Study 329. In 2002 he gave a talk on childhood depression at a medical conference in Toronto sponsored by GSK, attended by 15,000 psychiatrists. He said that Seroxat could be a suitable treatment for children and later told Shelley Jofre that it probably lowered rather than raised suicide rates.

And among the archive of documents in the lawyers’ possession, Jofre found the evidence that Ryan had forwarded to GSK her own e-mails to him from 2002 asking questions about the safety of Seroxat. His covering e-mail asked the company for advice on how to respond to her queries.

Nonetheless, the paper, of which Keller and Ryan claimed authorship, was published — but not before one journal turned it down after its peer reviewers found serious flaws, notably the downplaying of adverse reactions to Seroxat among the children trialed.

Last year, Professor Keller admitted to lawyers suing GSK that he had not studied the results of Study 329 in full. “I reviewed data analytic tables. I don’t recall how raw it [the data] was. [These are] huge printouts, you know, item by item numbers and variable numbers, and don’t even have words on them. I tend not to look at those… I do better with words than I do with symbols,” he recounted in a session recorded on video. In effect, he admitted that his ‘authorship’ of the paper, apart from being written by a PR company’s ghost, was based on at best an inadequate and incomplete scrutiny of the data — hardly the gold standard scientific review we are constantly told validates clinical trials.

Says Karen Barth Menzies: “These academics are truly spokespersons for the drug companies.”

But the drug company in question, GlaxoSmithKline, buried the trial data, including data from another, later trial on children which found that the placebos given to the control group of depressed kids ‘worked’ better than Seroxat. And later, forced by US medicines regulator the FDA to re-evaluate the raw data from Study 329, the company admitted to four further adverse reactions in which children became suicidal, raising the number suffering severe reactions to the drug from seven to 11 — a shocking 12 per cent of the total, and representing a 600% increase in events related to suicide.

Memos in the lawyers’ boxes of GSK papers show that company executives clearly told the PR woman who designed their spin strategy that ‘Seroxat may have caused all of these’. Yet the final article, approved by the PR, stated: ‘Of the 11 patients, only headache (one patient) was considered to be related to the treatment’ and concluded that the drug was ‘generally well tolerated and effective’. This was, finally, reviewed by and accepted for publication in the Journal of the American Academy of Child and Adolescent Psychiatry. And it was published relatively unchanged, even though the journal’s peer reviewers objected in these terms: ‘Overall, results do not clearly indicate efficacy. Authors need to clearly note this.’ ‘The relatively high rate of adverse effects was not addressed in the discussion (core portion of an academic paper)’ ‘Given the high placebo response rate, are these drugs an acceptable first-line therapy for depressed teenagers?’

Though the article appeared, GSK abandoned a part of its PR plan which intended to use it extensively in publicising Seroxat’s use with children. At company headquarters in Britain, a PR executive commented: ‘Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially, the study did not show [Seroxat] was effective in treating adolescent depression, which is not something we want to publicise.’

After publication, the third of GSK’s trials reported that the placebo worked better than Seroxat. The company’s public claims had been flatly contradicted by its own trial, but it maintained a deafening silence on this, telling doctors instead that Study 329 showed the drug ‘was superior to placebo by several assessment methods’. The two failed studies were not mentioned either when GSK informed its US sales force that Seroxat/Paxil ‘demonstrates remarkable efficacy and safety in the treatment of adolescent depression’.

“They didn’t tell the regulators or physicians or parents about these risks or the lack of efficacy. Instead, they went out and promoted this specific study as remarkably effective and safe for kids,” says Menzies. “That’s a lie. A fraud.”