GlaxoSmithKline - The Questions

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


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GSK and PTA

We all know who GSK are but do we know who PTA are?

The Parent Teacher Association

Membership is open to anyone who believes in the Mission and Purposes of National Parent Teacher Association. Individual members may belong to any number of PTAs and pay dues in each. Every person who joins a local PTA automatically becomes a member of both the state and National PTAs.

Together we are a powerful voice for children.

PTA Vision
Making every child's potential a reality.

Commitment: We are dedicated to promoting children’s health, well-being, and educational success through strong parent, family, and community involvement.

One of PTA's proud sponsors?

Yup, you've got it.

GlaxoSmithKline

GlaxoSmithKline (GSK) is pleased to be a proud sponsor of the PTA educational campaign, the Healthy Lifestyles Parents' Guide. GSK and PTA uphold a mutual commitment to the health and well-being of children.


Kind of makes you wanna throw up don't it?

I've wrote to the PTA with the MHRA's recent findings. I hope they do the honourable thing and remove GSK as one of their sponsors.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

UNITE AGAINST BULLYING (For JP Garnier)

How JP Garnier and GSK Employees

Bullied Dr. Buse.

SEROXAT SUFFERERS IS A PROUD SUPPORTER

OF UNITE AGAINST BULLYING

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Monty Burns and Avandia Renegade-gate‏

Matt Holford over at 'It's Quite An Experience' shoots from the hip with his email to the MHRA regarding the bullying tactics of JP Garnier (Monty Burns)

I've republished here for your perusal. It contains language of an adult nature so if easily offended don't read on.


Given the MHRA's recent decision not to pursue GSK, I thought I'd stick the boot in - this one's been simmering just beneath the surface for a while, so it's not shy on invective. This to the Ministry of Truth, copied to Vara, Johnson and the White House, blind copied to lots of people:

Dear Sir or Madam,

I am keen that nobody should misunderstand the moniker that I have given to Garnier: one is a shady bastard, who lives in his own private fantasy world, where he may do anything that takes his fancy and avoid the consequences, and the other is a cartoon character. I'm going to quote the Senate Finance Committee's report into the intimidation of Dr John Buse at you, at every possible opportunity:

GSK’s behavior since these allegations [came] to light has been less than stellar. Instead of acknowledging the misdeed to investors, apologizing to patients, and pledging to change corporate behavior, GSK launched a public relations campaign of denial. Specifically, GSK sent out a press release titled “GSK Response to US Senate Committee on Finance” which stated that the allegations raised by the Committee were “absolutely false.” Further, CEO Jean-Pierre Garnier denied having any knowledge of the alleged intimidation of Dr. Buse in an interview that ran in July in The Philadelphia Enquirer."

Ouch - not many fans on Senate Finance Committee, then, I guess? "Instead of... apologizing to patients, and pledging to change corporate behaviour... GSK launched a public relations campaign of denial..."? Hmmm, there's something about that, that I can't quite put my finger on...

And later we discover that Monty was lying about his knowledge of the incident (what other extremely important matters does he lie about, I wonder?), or if he wasn't lying, then I'd be delighted to have him reconcile for me his claim in The Philadelphia Enquirer, as against the following excerpt:

"In response to [a] series of emails, Dr. Tachi Yamada, GSK’s head of research at the time, wrote in an email that he had discussed Dr. Buse with GSK’s CEO Dr. Jean-Pierre Garnier as well as David Stout, a senior GSK executive. Dr. Garnier and Mr. Stout are copied on the email. Specifically, Dr. Yamada’s email reads: In any case, I plan to speak to Fred Sparling, his former chairman as soon as possible. I think there are two courses of action. One is to sue him for knowingly defaming our product even after we have set him straight as to the facts—the other is to launch a well planned offensive on behalf of Avandia…"(Source: The Intimidation of Dr. John Buse and the Diabetes Drug Avandia - it's a super read, I really do recommend it)

"Setting him straight as to the facts."? I'll bet Yamada's "facts" barely qualify as opinions. How do these fuckwits get their PhDs? Do they buy them out of the back of Private Eye, or something?

So, the lesson we take from this is that when Monty and his ilk feel that the reputation of their snake oil remedies is under threat, they wheel out the well-oiled intimidation machine and pretend that they are exercizing their legal right. Monty, Yamada, Stout: what a bunch of crooked cunts they would have to be to either actively engage in this type of activity, or to give it their tacit approval by remaining silent while it played out (by which I mean that they would have to be devoid of any admirable human characteristics). Sadly, I'll bet they're not the only ones. In fact, I know they're not, because it's "just business, nothing personal" isn't it? Intimidation = business? I'll remember that - it's another of your unspoken rules, isn't it?

Ah, isn't it great to have opinions? They're the last refuge of free speech, you know.

Best regards

Matthew Holford

PS It's a side issue, given that I just wanted to establish my contempt for Monty, but the Committee report asserts that many lives would have been saved, had GSK not sought to suppress Dr Buse's concerns. Just something to think about.

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Seroxat - A Time To Kill

I'm a big fan of John Grisham and think this video is quite apt regarding the recent MHRA investigation into GlaxoSmithKline. The subject matter is not important, however, the message is.

The clip is taken from the movie, 'A Time To Kill'. It's Matthew McConaughey's closing speech to members of the jury.

I want the members and employees of the MHRA, GlaxoSmithKline, the Department of Health and all lawyers & insurers associated with them to 'close their eyes' and imagine that one of their children has committed suicide as a result of taking Seroxat.

I have nothing further to add other than this message of conscience.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Seroxat - The Legal Questions That Must Be Asked

Here is the post in its entirety that prompted me to write the MHRA and pose 6 questions.

The post comes from HEAD OF LEGAL BLOG and the author, a former barrister and advisor to Tony Blair's government on EU, human rights and public law, has gave me permission to republish it on here.

Seroxat - The Legal Questions That Must Be Asked

Yesterday the Medicines and Healthcare Products Regulatory Agency announced it had decided not to prosecute GlaxoSmithKline for offences under medicines legislation, although it says GSK failed to inform it promptly of data it had from clinical trials suggesting that the anti-depressant drug Seroxat (GSK's UK brand name for the active substance paroxetine - marketed in the US as Paxil) is associated with increased suicidal behaviour in some depressed children. Here is the MHRA webpage with its press release and related documents.

At the time the MHRA found out about this data about seven thousand under-18s were being prescribed the drug - so GSK's late reporting is bound at the very least to have caused some British teenagers to have suicidal thoughts. Who knows whether some young person died because of this. In fairness I should say that GSK deny they reported the data late. The MHRA claims that GSK knew as early as 1998 that Seroxat was ineffective in treating children's depression. But it didn't tell them. Amazingly, it planned in 2003 to apply for a licence specifically for children!

In my view, this whole affair represents a serious failure of the medicines regulatory system, and a number of hard questions need to be asked of the MHRA Chief Executive Kent Woods, and of health ministers. In particular:

Were the MHRA and its lawyers right to think that GSK was not, or may not have been, required to report adverse reactions from Seroxat used in trials outside the terms of its UK marketing authorisation?

Were they right to think Seroxat was not authorised for use in children?

Why were MHRA officials unable to question GSK staff?

Does the MHRA have the powers it needs to properly regulate pharmaceuticals industry?

This monster post is my attempt to explain why I'm not satisfied with the MHRA's explanation for its decision, and why I think these questions need to be answered.

The key document explaining the decision not to prosecute is this MHRA report into its investigation and legal consideration of prosecution. In the remainder of this post I'll refer to various paragraphs in that report.

Were the MHRA and its lawyers right to think GSK may not have been required to report adverse reactions in trials outside the terms of Seroxat's license?

Para. 33 sets out the potential offences that were considered in this case. From 28 February 2002, Schedule 3, paragraph 10(d) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 it was an offence for a "qualified person" (a specialist that every drug firm must employ specifically to provide information to the regulator) to fail to provide to the MHRA any information relevant to the risk/benefit analysis of a medicine as required by the European Medicines Code, Directive 2001/83.

I've not posted a link to the Regulations because the version on the Statute Law Database is out of date; the MHRA document correctly explains the position as from 2002.

So what did the EU Code require? As para. 42 of the MHRA report says, article 103d of the Code says the qualified person is responsible for providing to national regulators any information relevant to evaluating the risks and benefits of a medicine.

I think that's all very clear. The EU Medicines Code requires the QP to give the regulator any risk/benefit data; and the UK Regulations make it an offence for the QP to fail to fulfil that responsibility. So why did the MHRA think there was some doubt here about whether late reporting would amount to an offence?

Paragraph 49 of the report explains this. It explains that the requirement in article 103d of the Code to report information on post-authorisation safety studies only covers studies of the drug within its licensed use.

That is I presume because post-authorisation safety studies are defined in article 1.15 of the Code as studies carried out in accordance with the marketing authorisation of a drug. But in addition this view sees article 102 of the Code, which requires national regulators to maintain a pharmacovigilance system to ensure good regulatory decisions having regard to adverse reactions under normal conditions of use, as colouring what information a qualified person must provide. According to this argument, the normal conditions of use are those approved in the marketing authorisation.

I have to say, I have real problems with this legal view. Firstly, article 103d of the Code does not limit the qualified person's responsibility to report simply to data gathered in "post-authorisation safety studies". The qualified person must in any event report any other information that relates to risks and benefits. So the definition of "post-authorisation safety studies" is simply irrelevant.

Secondly, I don't read article 102 as cutting down or limiting what the qualified person must report; it simply explains in very general terms what the purpose of pharmacovigilance is as far as regulators are concerned.

In any event, thirdly I think it is too much to read the phrase normal conditions of use in the Code as meaning use within the terms of a marketing authorisation. It helps when thinking about this to consider article 116, which gives the regulator power to revoke marketing authorisation, and article 117 which enables it to recall products and stop further supplies. Under article 116, revocation can happen where a drug is harmful under the normal conditions of use, is ineffective or where the risk/benefit balance is not positive under the normal conditions of use. Do the MHRA's lawyers seriously think that the fact that a serious risk arises from a drug only when used outside the strict terms of its authorisation - say, if you dropped dead if you took those two paracetamols just a little less than fours hours after the previous two - means the MHRA could not withdraw authorisation? That'd be silly. If people did start dropping dead for getting their timings wrong, you can be sure the MHRA would revoke authorisation for paracetamol on the basis that the normal conditions of use, in the real world, are not necessarily in all respects strictly limited to the authorised use.

I must be fair, and refer you to article 117. That as I've said is about product recall and impounding products at the factory gates, something the regulator can do if the product is harmful under the normal conditions of use, is ineffective or where the risk/benefit balance is not positive under the authorised conditions of use. Now, admittedly, this drafting causes confusion since it seems to suggest that the phrase authorised conditions of use can be used interchangeably with the phrase normal conditions of use. There's no easy answer to this, European legislation being drafted pretty slackly on the whole. It'd be misconceived to attempt to draw some fine distinction between articles 116 and 117 or even between the different grounds for withdrawal under article 117. I can't rationalise away this drafting problem.

But equally, it doesn't work to rationalise it away by concluding that revocation and recall can only happen on the basis of harmful authorised use. That would actually run counter to the purpose of the Code, as revealed by recital (2), which says its essential aim must be to safeguard public health - and EU legislation must of course be interpreted purposively, in line with its aim.

Let me put it more starkly. The MHRA report says use in children is outside the authorised use. Would the MHRA claim that, if those children who were prescribed the drug all killed themselves en masse, it as the regulator would have no power to revoke the authorisation? Of course it wouldn't. The product would be harmful in the normal conditions of use even if that use was unauthorised.

That ends up being a long way of explaining why I think it's clear that GSK's qualified person was required by law to inform the MHRA of the results of its trials, both as regards efficacy and safety, and why any failure to do so was an offence. The view of the MHRA lawyers seems to me an excessively cautious one, implying a very feeble view indeed of the duties of drug firms and the powers of the regulator.

Were the MHRA right to think Seroxat was not authorised for use in children?

Let me begin by saying it seems to be widely believed among drug firms, regulators and health care professionals that a medicine is not licensed for use in children unless the terms of its license explicitly say so. And ministers have said in Parliament that Seroxat was never licensed for use in children. My view of this will seem, therefore, contrarian. But it seems to me that Seroxat probably was licensed for use in children anyway.

How do you know what a drug is, and is not, licensed for? Well, if we could see a document called a marketing authorisation making it clear Seroxat is only licensed for use in adults, that would settle things. But I'm not sure such a document actully exists, or is available online. What does exist is the MHRA's published "UKPAR", or UK Public Assessment Report, a document which summarises the scientific basis on which marketing authorisation has been granted. Here's an UKPAR for generic paroxetine. In that document there is no mention of children except in the text of the SPC or summary of product characteristics, which is a document aimed primarily at doctors explaining the drug's use and which must be approved by the MHRA. Here's Seroxat's SPC. You can see that sections 4.2 on posology, and 4.4 on special warnings, both say Seroxat should not be used in children. It seems to me that it's on these statements and these statements alone that the MHRA believe Seroxat is not licensed for children.

Well, fair enough: those statements are pretty clear, and I'll buy that argument. But what did the SPC say before the MHRA was told about the increased risk of suicidal thoughts? Paragraph 2 of the MHRA report tells us that. The SPC said (presumably in section 4.2 on posology):

The use of Seroxat in children is not recommended as safety and efficacy have not been established in this population.

Is that it? I have to say that that standard wording, to me, seems very different from a clear statement that use in children is not authorised. What's more, paragraph 14 of the MHRA report tells us that, once the MHRA knew about the increased suicide risk, it asked GSK to submit a variation to the marketing authorisation contraindicating use in the under 18s. So aren't I right to suggest the authorisation was not clearly limited in that way before.

And another thing: article 116 of the EU Code say that a marketing authorisation can be varied if the risk/benefit balance is not positive in the normal conditions of use. If Seroxat wasn't licensed for use in children, as the MHRA are now saying, and if the normal conditions of use means simply licensed use, as the MHRA's lawyers seem to have concluded - how come the MHRA had power to vary the authorisation? None of this adds up.

Why were MHRA enforcement investigators unable to question GSK staff?

Paragraph 23 of the MHRA report tells us that GSK staff, presumably including the qualified person,

declined invitations to attend interviews under caution

Amazing. I think I'd decline an invitation like that, too. But shouldn't the MHRA have powers to require someone to attend for questioning (which would not be the same as making it compulsory to answer)? Shouldn't they be able to apply for a warrant of some kind? Why didn't they get the police involved? After January 2006 they had power to arrest GSK staff for questioning in relation to these offences. Here's Alison Hannah's critical explanation of the new powers.

Does the MHRA have the powers it needs to properly regulate pharmaceuticals industry?

This whole affair seems to me a serious failure of the medicines regulatory regime, a regime riddled with legal confusions, doubtful assumptions, excessive caution and misunderstanding. Does the MHRA have power even to vary drug licences in these circumstances? They seem not to think so. How can it be that the regulator thinks the law doesn't require this safety data to be passed to it? Why does the MHRA seem so toothless in the face of the drugs industry? I'm glad legal changes are being made now, but are they really necessary, or is my analysis correct? Is the regulator being unduly cautious about its powers? Why have these "gaps" in the law, if indeed they are gaps, only been spotted now?

I'm not sure this regulatory system is fit for purpose.

Carl Gardner
Head of Legal
London, United Kingdom

As a barrister, I advised Tony Blair's government on EU, human rights and public law for over a decade. I'm now a freelance writer and lecturer.

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

MHRA FOI Request Re GSK Investigation.

A thoroughly insightful link was sent to me from Janice Simmons of the Seroxat & SSRi User Group.

It's a link to a blog written by a writer and lecturer and as a barrister, he advised Tony Blair's government on EU, human rights and public law for over a decade.

He raises some thoughtful questions regarding the recent MHRA investigation into GlaxoSmithKline.

It's a must read - HERE

I have taken the liberty in asking 6 questions of the MHRA. I have asked these under the Freedom of Information Act.

----


----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Cc: Kent Woods
Sent: Saturday, March 08, 2008 5:06 PM
Subject: FOI Request



Dear Sirs,

I wish for the following questions to be answered. They all refer to your recent investigation into GlaxoSmithKline.

I would like to point out that I have not prejudged the veracity of any answers you may or may not give.

As a concerned British citizen, I feel it my duty to publish any answers you may or may not give on the world-wide web.

1.Were the MHRA right to think Seroxat was not authorised for use in children?

2. Is there, or has there ever been, a document called a marketing authorisation making it clear Seroxat is only licensed for use in adults?

3. If Seroxat wasn't licensed for use in children, as the MHRA are now saying, and if the normal conditions of use means simply licensed use, as the MHRA's lawyers seem to have concluded - how come the MHRA had power to vary the authorisation?

4. Why were MHRA enforcement investigators unable to question GSK staff?

5. Does the MHRA have the powers it needs to properly regulate pharmaceuticals industry?

6. When interviewed on BBC TV's Panorama, MHRA Chairman, Alasdair Breckenridge was asked whether or not criminal charges would be brought against GSK. He answered 'That is a possibilty'. Are we now to assume that this was a lie?

You may notice that these questions have already been posted elsewhere on the internet, I am unsure as to whether they have already been sent to you.

With that said, I would like the questions answered as a matter of public interest/concern and hereby request that they are under The Freedom of Information Act.

Regards

Mr Robert Fiddaman

----

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

How to market Seroxat for adolescents - 1998

Benbow statement from 2008

GSK has rejected claims it improperly withheld drug-trial data. Dr Alastair Benbow, medical director for GSK Europe, said: "We firmly believe we acted properly and responsibly in first carrying out this 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."

Then why didn't you tell the regulators about this internal memo from 1998 Mr Benbow?

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Seroxat - Taken on Trust

PART ONE

PART TWO




PART THREE



PART FOUR



PART FIVE



PART SIX



PART SEVEN



Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Alistair Benbow GSK Please Shut Up!

Well, the explosives of yesterday seemed to have settled somewhat. Normality for those of us who have not lost children to Seroxat but more heartache and frustration for those parents who were looking toward the MHRA for some form of justice. Justice has most definately NOT prevailed with the slap on the wrists for JP Garnier and GlaxoSmithKline.

What now for those parents who lost their children? What now for the young adults who went through a whole range of adverse efects whilst on Seroxat in their teens?

There has not even been an apology.

Alistair Benbow made a statement that did not contain the word 'Sorry'

Kent Woods made a statement that did not contain the word 'Sorry'

In fact although the MHRA had found that GlaxoSmithKline did not offer up results as quick as they should have, Benbow was still in denial.

Can't the MHRA get this man to shut his trap once and for all?

Is he aware that there were a lot of bereaved folks out there counting on the MHRA to give them a sense of justice. The fact that the MHRA failed should not warrant the smug Benbow spouting “The safe use of our medicines is paramount to everyone who works for GSK and the company is committed to ensuring that all appropriate information is made available to regulators, doctors and patients."

Do you know how that must feel to a parent whose child took their own life because the pill that was supposed to make them better infact made them worse, to such a degree that the chemicals inside that drug made them kill themselves!

Show some human compassion Mr Benbow. You even had to throw the word in 'appropriate' didn't you. Yes we know all about the 'appropriate' information - but who or whom was it appropriate for? It certainly wasn't appropriate for the off-label prescribing to children was it?

You were found guilty Benbow - now deal with it!

Instead of defending your company why don't you offer an apology. In the history of GSK has there EVER been an apology?

Show some compassion and empathy Mr Benbow. People are still grieving so would you please keep your mouth shut... unless you want to publically apologise - which I doubt very much.

We all saw your performance on BBC TV's Panorama.

Remember your interview with Shelley Jofre?

Jofre: And you still think that the drug (Seroxat) could be safe for children?

Benbow: Absolutely, it could be, we haven't got a licence in children yet...

That was April 2003 Dr Benbow (I use the term 'Dr' loosely)

What were you playing at?

For those of you new to this blog you can see segments of the interview HERE

The 'Absolutely, it could be' line kicks in around the 20 second mark.

Now Mr Alisatiar Benbow I think it is 'appropriate' that you either offer an apology or just keep your smug mouth shut!

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

GSK statement on MHRA investigation

Good old Alistair Benbow is in fine form again - basically denying any wrong doing.

Basically, I see this whole hiding of data as a relationship between two people.

Call it a marriage if you will.

The husband is loyal, honest and caring and he assumes his wife is as well.

A few years into their marriage, she has an affair, she does not tell her husband... he finds out through a third party. He is obviously devasted and feels he can't trust her anymore. She assures him that it was a 'one off' and she will never do it again.

But the wife is of the opinion that if she does not lie to her husband then she is doing no wrong. She convinces herself that she is not lying because he hasn't asked her.

So, she, in her own warped mind, can have another affair. To her she is doing no wrong. She can even disguise her lies later on. Her husband may ask her 'Are you seeing someone else?' Her conscience won't be pricked because she has already decided that she isn't seeing another man (he is seeing her!) therefore when she replies to her husband 'No, I am not seeing anyone else', she feels vindicated. Her husband may ask her, 'Are you sleeping with someone?' Again she can disguise her lie to keep him from the truth, 'No, I'm not sleeping with someone.' In reality she is having sex with someone but because her husband asked her if she was sleeping with someone she only needs to answer whether or not she has been sleeping with him.

It's a classic case of the liar convincing not only themselves, but others too that they are doing no wrong.

Here, GSK were asked 'Have you been hiding data from us?'

Of course we all know that they did but they could answer 'No' because the data that they only had to provide (by law) was the positive data. So they were perfectly within the letter of the law to answer 'We are not hiding data from anyone'.

However, where GSK slipped up was when they submitted evidence to the MHRA to support a licensing application for Seroxat use in children. Once again, they did this on the basis of only having to provide the data they wanted to.

If we can go back to the husband and wife scenario, it can become clearer.

The wife tells the husband she is going away on holiday with a friend.

On her return she shows him some photographs that she has taken whilst away on some exotic island. The photographs look innocent enough, there are no indications that she is having an affair. She feels vindicated. Although she did go on holiday, she didn't quite tell her husband the whole truth (because a, she didn't have to and b, he never asked)

Sometime down the line, the husband asks her why there are only 33 photo's when the camera could take a maximum of 48 photo's? 'Oh, they were just boring photo's of the airport darling', she replies. Once again she is not actually lying, they were photo's taken at the airport but they included her lover. Her husband never asked her a direct question like 'Do the other photo's contain your lover?' Why would he, he had no inkling.

Where the MHRA investigation lets us all down is quite simple really.

They knew the questions to ask but they never asked them. They could have asked, 'the information that you never gave us contained bad results did it?' Of course GSK could have answered 'No'... and again in a perverse kind of way, they would have been telling the truth. They could vindicate themselves by answering 'No' because not ALL the information they kept from the regulator was bad... just some of it. Therefore, in their eyes, they have not lied. But the MHRA had evidence. Dr David Healy, the World's leading SSRi Expert had sent it to Dr June Raine of the MHRA nearly 8 years ago. Why didn't the MHRA (the husband) confront GSK (the wife) with this evidence?

It's akin to President Clinton and Monica Lewinsky. 'I did not have sexual relations with that woman'. He obviously knew that he did, but he vindicated himself because he had convinced himself that oral sex did not fall under the 'sexual relations' label. Once convinced, he was free from any form of guilt or conscience.

Ladies and gentlemen, I give you Alistair Benbow's take on the recent MHRA investigation:

Statement here


GlaxoSmithKline (GSK) notes the conclusions announced today by the Medicines and Healthcare products Regulatory Agency (MHRA) regarding its investigation into disclosure of paediatric trial data for the anti-depressant medicine Seroxat (paroxetine).


“The safe use of our medicines is paramount to everyone who works for GSK and the company is committed to ensuring that all appropriate information is made available to regulators, doctors and patients. 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,” said Dr Alastair Benbow, Medical Director for GSK Europe.

“Whilst there are substantive and rigorous requirements in place regarding disclosure of clinical trial data, it is clear that there is a need and benefit to strengthen the confidence of decision-makers and the general public that all pharmaceutical industry clinical trial data are disclosed promptly and transparently. GSK is committed to working with the Government, appropriate regulatory authorities and other pharmaceutical companies to take whatever action is necessary to improve legislation and policy in this area,” he added.


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Kent Woods Sycophantic Letter to JP Garnier

When I was young, I played truant from school. My punishment was the cane, on my hand.

It hurt.

It was however a valuable lesson.


When the CEO of a pharmaceutical company named GlaxoSmithKline knowingly hides information that could have saved children's lives he gets investigated.

The investigation is carried out by the MHRA. Leading the investigation is Prof Kent Woods, the CEO. The investigation finds that GlaxoSmithKline purposely kept data from them.

Click on the images above to see what punishment JP Garnier, CEO of GlaxoSmithKline recieved off Kent Woods, CEO of the MHRA.

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON