Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Wednesday, September 30, 2009

Cervarix Vaccine: " Unlikely Cause of Death"




Well, it would appear that GlaxoSmithKline's Cervarix vaccine was not the cause of 14 year old Natalie Morton's death, at least that are the reports coming from the mainstream media. It's all very confusing - one minute Coventry health officials are suspending the immunisation programme, the next they are announcing that they are not? Even more strange are the reports that the programme has been halted in other parts of the UK such as Knowsley, Halton and St Helens [Liverpool Daily Post] - Also, the Wales Online website claims that the batch used to immunise Natalie Morton and her school friends had been withdrawn from use in Wales?

A press release from the Medicines Healthcare and products Regulatory Agency [MHRA] states that the HPV Vaccine batch has been recalled while investigation underway. [Link] MHRA Chief Executive, Professor Kent Woods, said the risk/benefit profile for Cervarix remains positive and that the safety and efficacy of the vaccine had been extensively researched in clinical trials before licensing. All this without the results of Natalie Morton's autopsy? All we have, from the mainstream media thus far is that Natalie had an 'underlying health problem' and that the Cervarix was the 'unlikely cause of her death'. Unless of course the MHRA have privy information regarding Natalie's health?

It all seems rather strange to me that a decision of whether or not a vaccine is safe has been made overnight when there is no information on exactly what the 'underlying health problem' was.

Professor Woods has also gone on record claiming, "...many women’s lives will be saved in the future as a direct result of this vaccine." I'd like a peek inside Professor Woods crystal ball or would like to see the data that he has seen that shows that 20 years from now women who had this vaccine have benefited from it. Professor Woods should not make these claims because the long term benefit of Cervarix has not been proven yet - unless there has been some mysterious clinical trial from the late 1980's?

I'm not having a 'pop' at the MHRA CEO, I've met him, he's a fairly decent chap but I do wish he would think before making such rash statements regarding a vaccine that has not had 20 or so years of clinical study.

Then we have a case that has pretty much slipped off the radar regarding Cervarix and another school girl. Paige Brennan was immunised with Cervarix in March. Six months on, the 13-year-old is still unable to talk or walk properly after falling ill with a virus following her jab. But hey, that's okay because "...many women’s lives will be saved in the future as a direct result of this vaccine."

The Mirror writes, Mum Margaret, 40, who visits Paige every day at Birmingham Children's Hospital, is adamant she won't allow younger daughter Chloe to have it when the time comes.

Margaret said: "Since Paige's illness I have researched so many similar cases of girls whose nervous systems have been mysteriously struck down in the same way.

"It's tragic that it takes the death of a teenager to make someone sit up and listen. For all we know we could be harming a whole generation of teenage girls."


The UK government should also take some responsibility here. They, it appears, were given a choice of vaccine, Merck's Gardasil or GSK's Cervarix. They opted for Cervarix. It's a classic case of two products being identical, let's say for example two George Michael CD's in your local record store, one for sale at £12, the other in the 'Bargain Bin' at £8. We'd all jump at the chance of buying the cheaper CD would we not? Vaccines are different and no price should be put on the well-being of our children. Gardasil and Cervarix are the same aren't they, or am I wrong? Does Gardasil have a bonus track on? Damn, I should have looked more carefully at the George Michael discs!

Can we expect an impartiality from the UK government? Well, look at Prime Minister Gordon Brown's National Business Council and you see that one of its advisor's is none other than Andrew Witty, chief executive of drug developer GlaxoSmithKline PLC. Previously Gordon Brown had recruited Jean-Paul Garnier, the then GlaxoSmithKline chief, to serve on the Business Council.

A young girl has died and whether or not Cervarix was the cause of Natalie Morton's death, it should not take this to bring the Cervarix immunisation programme up for debate. We certainly don't need the Chief Executive of the UK Medicines Regulator promoting future sales of the vaccine!

There seems to be a break neck speed race to have children vaccinated with Cervarix, it's almost as if there is a huge crisis of cervical cancer in women. In truth there isn't. In 2005, 911 women died of the disease, yes it's a high figure but when you run it past other figures you will see it pales next to the 12,000 who died from lung cancer or the 11,000 who succumbed to breast cancer. Cervical cancer comes in 19th place on the list of cancers that kill women in modern Britain.

It will be 20 years before we know whether Cervarix is effective in preventing cervical cancer. Unless of course you are privy to take a peek inside the MHRA's crystal ball.

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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The placebo problem Big Pharma's desperate to solve





Fascinating piece from this month's edition of 'Wired' entitled 'The placebo problem Big Pharma's desperate to solve.'

It's good to see articles like this in mainstream magazines. An interesting paragraph reads:

"One estimated that the so-called effect size (a measure of statistical significance)in placebo groups had nearly doubled over that time. It's not that the old meds are getting weaker, drug developers say. It's as if the placebo effect is somehow getting stronger.

The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis".


The full article can be read HERE

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Tuesday, September 29, 2009

US Cervarix delay deals blow to GlaxoSmithKline




US regulators have delayed their decision on whether to approve GlaxoSmithKline's cervical cancer vaccine Cervarix, writes the Daily Mail.

They add, "The ruling from the powerful US Food and Drug Administration had been expected yesterday but instead the body announced it needed more time to consider the application.

The FDA's renewed caution came just a day after the death of 14-year- old Coventry girl Natalie Morton who had been vaccinated with Cervarix."


FULL STORY HERE

Related links:

Cervarix Tested For Boys!

GlaxoSmithKline challenged safety Cervarix anti-cancer vaccine left girl partially paralysed

4,602 Suspected Adverse Reactions to GSK's Cervarix!

Girls used as Guinea Pigs in HPV Trials Admits GSK

GSK - A Catalogue of Disasters!

Glaxo: "Promote More, Feel Better and Live a Life of Luxury"

Glaxo Goes Head-to-Head on HPV

Teenage Girls Sue Over GSK's Cancer Jab, Cervarix!

GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine

HPV Vaccine Video on Youtube

Concerns over GSK's Cervarix vaccine

UP YOURS GLAXO!

Mindy Merck & Gail Glaxo Dilemma

LOLA'S LAND PROMOTING HPV VACCINE

GlaxoSmithKline's Cervarix. Is Your Daughter Safe?

More debate on GSK's Cervarix

Cervical Cancer, Ofsted & GlaxoSmithKline

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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GLAXO RECALL CERVARIX VACCINE




News just in from the MHRA web page. Glaxo have have ordered a recall of Cervarix... but only one batch?

Judging by the letter, issued by Alison Bunce, Pharmaceutical Assessor, DMRC, it would appear that the investigation into the death of Natalie Morton [I prefer to give this child a name] has already concluded! The last line reads: "Further stocks of vaccine from different batches can be ordered in the usual way."

It would appear that their minds have already been made up whether or not Cervarix was the cause of Natalie Morton's death.



Dear Healthcare Professional,

GlaxoSmithKline Biologicals sa

Cervarix suspension for injection in prefilled syringes

Human papillomavirus vaccine

Eu/1/07/419/004

Batch number - AHPVA043BB

Expiry date - 09/2010

Pack size - 1 Syringe + needle

First distributed - 1 May 2009

Following the tragic death of a young girl, who had received vaccination from the above batch of Cervarix, the Department of Health has issued a quarantine notification.

As a further precautionary measure, GlaxoSmithKline Biologicals sa is now undertaking a voluntary recall of the above batch of Cervarix pending further investigation.

Please quarantine any remaining stocks of this batch. Movianto UK Ltd will contact customers directly regarding stock and the details of the product to be collected. Movianto can be contacted by email (customercare.uk@movianto.co.uk)

The benefit risk assessment for the vaccine remains unchanged; there is currently no proven link between vaccination and the event and the HPV vaccination programme will continue.

No other batches are affected by this recall. Further stocks of vaccine from different batches can be ordered in the usual way.

Recall Announcement HERE

Fid

Related articles:

Cervarix tested for Boys!

Natalie Morton, 14 Dies after Cervarix jab

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Cervarix tested for Boys!




It would appear that my Blackheath cyberstalker, Mardi Bennett, is now accusing this blog of scaremongering regarding the Cervarix issue.

She writes on the UK Survivor's Forum:

"If you're so concerned about this issue and want to raise awareness – wouldn't it make more sense to put links to relevant factual research, pharmacological information (including chemical ingredients) and medically based articles and websites here - so active members and those lurking and reading, could make informed choices - instead just posting flippant scaremongering statements, sensationalizing and quoting "facts" out of context and directing people to your website.

People could get the impression that you think your point of view, your blog (where "fact" and fiction are interwoven to express your opinion), condemning GSK and your viewer hit ratings are far more important that the actual issue!"


Well, I don't know exactly what Ms Bennett wants from me, she has, in the past, accused me of only being concerned about the dangers of Seroxat, despite my meeting with the MHRA where I raised concerns about ALL SSRi's.

For the benefit of Ms Bennett, I will point her and other readers of this blog to some interesting 'facts' regarding GlaxoSmithKline's Cervarix.

It is well-known that Merck's Gardasil is a rival vaccine to GSK's Cervarix. Those of you who have kept an eye on these vaccines will already know that an FDA advisory committee voted to recommend approval of the vaccine Gardasil for males ages 9 to 26 to prevent genital warts. [1]

Gardasil also contains Sodium Borate [2], also known as Borax. It has many common uses. In addition to its use as a rat poison, it is also used in laundry detergents and cosmetics.

Moving on to GSK's Cervarix. Rather than post the links where I have wrote about this before I will just refer you to one post that contains all the relevant links at the bottom [3]

What readers of this blog may not know is that, like Gardasil, GSK's Cervarix was part of a study to evaluate the immunogenicity and safety of the vaccine in males.

The study appeared in the Journal of Adolescent Health and was received 8 July 2008, accepted 6 October 2008 and made available online 21 December 2008.

Two members of this study, namely, Olivier Godeaux M.D and Gary Dubin M.D work for GlaxoSmithKline Biologicals, Rixensart, Belgium and GlaxoSmithKline Biologicals, King of Prussia, Pennsylvania respectively.

The study contains all the relevant information that Mardi Bennett requires [4]

May I suggest that Ms Bennett spend her time researching facts rather than write endless emails to the Medicines Healthcare and products Regulatory Agency [MHRA] about me and the work I do related to this blog. [5]

Here endeth the first lesson in 'factual evidence'

Fid







[1] FDA Panel OKs HPV Vaccine Gardasil for Boys

[2]
Gardasil Patient Information Leaflet

[3]
Schoolgirl, 14, dies and three classmates taken ill after being given GSK's cervical cancer vaccine. [Scroll to bottom for other links]

[4]
Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Vaccine in Healthy Boys Aged 10–18 Years.

[5]
Stalkers Request Information from MHRA and Blogger On Paxil's Dangers Draws Weird Attention.






Update: Coventry's cervical cancer vaccination programme has been suspended following the sudden death of a 14-year-old girl who had received the HPV1 Cervarix jab.





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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Natalie Morton, 14 Dies after Cervarix jab




The first pictures of Natalie Morton have surfaced in the British press after the 14 year old tragically died hours after being given the cervical cancer vaccine, Cervarix.

The Mail Online reports how a fellow pupil gave a dramatic account of how Natalie collapsed.

The 15-year-old girl said: "We all had the jab today from Year Nine to the sixth form.

About an hour after having the jab Natalie went really pale and wasn't breathing. I think it was around lunchtime.

She fainted in the corridor. I saw ambulance men pumping her chest then the teachers told us to go outside.

A lot of people were crying afterwards and we were all very worried.

We have to have three of the jabs in all and a lot of us don't want to take the rest, but they're telling us we have to because there will be sideeffects if we don't have them all."


Last night, there were calls for the entire cervical cancer vaccination programme to be suspended.

I have to say that I echo the call for the mass vaccination to be suspended until the death of this child has been fully and impartially investigated. I see no reason whatsoever why this cannot be done.

The article has provoked many comments from readers, one in particular who writes:

"Of 100+ types of HPV, only 10-30 can cause cervical cancer. The rest can lead to skin infections that cause genital or common warts on hands and feet. There's actually little cause for alarm because, in 90% cases, your body's immune system clears the HPV infection naturally within 2 years for both the wart- and cancer-forming virus.

Still, we are led to believe that getting the vaccine will protect girls from the slight risk of cervical cancer that does exist -- but this is not the case. The vaccine contains just 4 types of HPV (out of 100+ strains). If you contract one of the 96+ types that aren't included, you're out of luck. And, if you've already been exposed to one of the 4 types of virus in the vaccine, it doesn't work either.

This is all about money and profit, with no concern about true health well being."


Dr Pim Kon, medical director at GlaxoSmithKline UK, said: "Our deepest sympathies are with the family and friends of the young girl.

We are working with the Department of Health and MHRA (Medicines and Healthcare products Regulatory Agency) to better understand this case, as at this stage the exact cause of this tragic death is unknown."


Glaxo added that the vast majority of suspected adverse reactions have related either to the symptoms of recognised side effects or were due to the injection process and not the vaccine itself.

Cervarix was chosen for the NHS programme because it offered 'best overall value for the NHS'.

The NHS pays £80 a dose, plus admin and staff costs, and three jabs are given altogether.

Related Links:




GlaxoSmithKline challenged safety Cervarix anti-cancer vaccine left girl partially paralysed

4,602 Suspected Adverse Reactions to GSK's Cervarix!

Girls used as Guinea Pigs in HPV Trials Admits GSK

GSK - A Catalogue of Disasters!

Glaxo: "Promote More, Feel Better and Live a Life of Luxury"

Glaxo Goes Head-to-Head on HPV

Teenage Girls Sue Over GSK's Cancer Jab, Cervarix!

GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine

HPV Vaccine Video on Youtube

Concerns over GSK's Cervarix vaccine

UP YOURS GLAXO!

Mindy Merck & Gail Glaxo Dilemma

LOLA'S LAND PROMOTING HPV VACCINE

GlaxoSmithKline's Cervarix. Is Your Daughter Safe?

More debate on GSK's Cervarix

Cervical Cancer, Ofsted & GlaxoSmithKline

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Monday, September 28, 2009

Schoolgirl, 14, dies and three classmates taken ill after being given GSK's cervical cancer vaccine







Source Daily Mail

A 14-year-old schoolgirl today died shortly after being given the new cervical cancer vaccine.

The teenager collapsed at her school in Coventry after receiving the jab as part of a national immunisation programme.

She was taken to hospital but doctors were unable to save her.

Three of her classmates also suffered possible side-effects after being injected with Cervavix, which protects against human papillomavirus (HPV), this afternoon.

Read more

----

I've banged the drum about GSK's Cervarix before. Quite why this mass immunisation is going on baffles me. Stop this before the problem escalates - which I'm sure it will years down the line - just as it has done with other GSK drugs!

Links below - Includes the wanton promotion of this particular vaccine on a UK children's website!


GlaxoSmithKline challenged safety Cervarix anti-cancer vaccine left girl partially paralysed

4,602 Suspected Adverse Reactions to GSK's Cervarix!

Girls used as Guinea Pigs in HPV Trials Admits GSK

GSK - A Catalogue of Disasters!

Glaxo: "Promote More, Feel Better and Live a Life of Luxury"

Glaxo Goes Head-to-Head on HPV

Teenage Girls Sue Over GSK's Cancer Jab, Cervarix!

GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine

HPV Vaccine Video on Youtube

Concerns over GSK's Cervarix vaccine

UP YOURS GLAXO!

Mindy Merck & Gail Glaxo Dilemma

LOLA'S LAND PROMOTING HPV VACCINE

GlaxoSmithKline's Cervarix. Is Your Daughter Safe?

More debate on GSK's Cervarix

Cervical Cancer, Ofsted & GlaxoSmithKline

Is Cervarix and Gardasil Safe ? Humorous and very blunt answer.

Fid

SEROXAT SUFFERERS STAND UP AND BE COUNTED
Beware of Obsessive freaks posting as me

*GSK INTERNAL FILES BLOG

JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY





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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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WOUNDED!



WATCH HERE




Forgetting about Paxil and other SSRi's for a moment.

Let's stop and think.


Documentary following the journey of two injured soldiers: 19-year-old Ranger Andy Allen who, in July 2008, had his right leg blown off and his eyes badly burnt by an improvised explosive device; and 24-year-old Lance Corporal Tom Neathway, who lost three limbs after moving a booby-trapped sandbag.

Unconscious and watched by their families they fight for their lives, but surviving their injuries is just the beginning.

A truly moving documentary.

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Sunday, September 27, 2009

Big Announcement Tomorrow



Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Saturday, September 26, 2009

Paxil [Seroxat] "more powerful a teratogen than cocaine"







Quite an alarming statement, wouldn't you agree? Nonetheless it comes from the opening statement in the Kilker v GlaxoSmithKline trial.

Firstly, the definition of the word, 'teratogen' is thus:

a drug or other substance capable of interfering with the development of a fetus, causing birth defects. [1]

Doctor Sloot is a European doctor who works for Shearing Plough.

The following was taken from the court transcript in the current Kilker v GlaxoSmithKline trial, currently on-going in Philadelphia, US. [2]

"In May of this year, 2009, a study was published by Doctor Sloot. The study said this.

What Doctor Sloot did is, he took Paxil and all the other reuptake inhibitors and he exposed rat fetuses to these 12 different drugs, including Paxil. And what Shearing Plough was trying to figure out, what they were trying to do was figure out whether one of the drugs that they were going to put on the market to compete with GSK's drug was capable of causing birth defects. And so they took the drug they were going to take to market, and before they took it to market, they did this test. And they compared it to all the other SSRIs. Because, as you will learn, GSK never did this test.

What Doctor Sloot discovered in May of this year is that out of all the teratogen, out of all the SSRIs, the 12, only one was a clear teratogen, Paxil. He discovered that Paxil in May of this year was actually more powerful a teratogen than cocaine.

It would be safer, according to Doctor Sloot's study, to take cocaine than it would be to take Paxil while you were pregnant.

Now, Shearing Plough, quite rightly, took their drug that they were thinking about taking to market to compete with Paxil, and even though it was just a possible teratogen, they scrapped their plans to take it to market and decided the risk was not worth the benefit."


More revelations can be found if you read the documents for yourselves. For the record, GlaxoSmithKline's arguments are featured in the documents and it is up to the reader to decide fact from fiction. The documents are now in the public domain and will no doubt cause much debate.


[1] http://dictionary.reference.com/browse/teratogen

[2]
9/15/09 AM: Opening Statements

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Friday, September 25, 2009

MARTIN B KELLER TO BE HONOURED




Does anyone have a cure for bile?


I have sick in my mouth after reading this.




The Department of Psychiatry and Human Behavior & Butler Hospital & The Alpert Medical School of Brown University.

invite you to a

Festschrift in Honor of Martin B. Keller, MD

Thursday, October 8, 2009 • 1:00 - 5:00 pm

Ray Conference Center • Butler Hospital Campus

Distinguished Speakers

Robert Hirschfeld, MD
“Diagnosis and Clinical Course of Mood Disorders: The NIMH Collaborative Study on the Psychobiology of Depression”

Lewis Judd, MD
“Longitudinal Course of Bipolar Disorders and Treatment Implications”

Katharine Phillips, MD
“Body Dysmorphic Disorder”

Alan Schatzberg, MD
“Putting Chronic Depression on the Clinical Map”

Myrna Weissman, MD
“Three Generations at Risk for Depression”



RSVP Required to attend.

Please email DPHB@Brown.edu for more information on how to RSVP to this event.

For Directions to Ray Conference Center at Butler Hospital Campus: http://www.butler.org/body.cfm?id=33

PDF File here

Read more about Keller HERE

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Kilker v GlaxoSmithKline - Raises questions about Charles Nemeroff

For full transcript refer to earlier post here. This particular segment comes from the direct and cross examination of David Healy.

Apologies in advance for the poor formatting of this post.

Mr Tracey is Attorney for the plaintiffs [Kilker's]

Ms Chilton is Attorney for the defendants [GlaxoSmithKline]


(Jury enters courtroom at 2:05 p.m.)


BY MR. TRACEY:

Q. Dr. Healy, who's Dr. Charles Nemeroff?

A. Dr. Charles Nemeroff was the Chief of Psychiatry from University of Emory down in Georgia.

Q. He is a psychiatrist?

A. He is. He's possibly best known or was the best known psychiatrist in the United States.

Q. Was he an influential psychiatrist?

A. Extremely influential.

Q. Who did he influence?

13 A. He influenced an awful lot of heads of departments, professors of psychiatry, general people within the field of academic mental health, and through them and an awful lot of prescribing doctors here in the U.S. And, indeed, perhaps worldwide.

Q. Was he the kind of doctor that if people wanted to know something about psychiatry, they looked up what he wrote so they could get his opinions?

A. His views would have been extremely influential.

Q. Was he on the GlaxoSmithKline advisory board?

A. Yes, he was. He was there from the start.

Q. Was he one of the founding members of the Paxil advisory board?

A. He was, I believe.

Q. Did he get paid for all of this?

A. He did.

Q. Did he do CMEs on Paxil?

A. He was involved -- he would have been the key person in producing the kinds of talks with slides that would have been held for large audiences of doctors, and then those slides and talks would have been distributed out to different doctors in the field who hadn't been at the major meetings as he gave his talk.

Q. Doctor, if you will turn to, I think, it's Tab 19.

MR. TRACEY: This is Plaintiff's Exhibit 337, if there is no objection.

MS. CHILTON: Same objection as before, Your Honor.

THE COURT: Overruled.

BY MR. TRACEY:

Q. Is Dr. Nemeroff here M.D., Ph.D, the Reunette Harris Professor and Chair Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia?

A. Yes.

Q. You actually know Dr. Nemeroff, don't you?

A. Yes.

Q. You talked to him and met him at meetings?

A. Over a 20-odd year period we met quite often. The most recent would have been actually May this year.

Q. Now, as Dr. Nemeroff -- do you know whether Dr. Nemeroff is still the chairman of the Department of Psychiatry at Emory?

A. Yes, I do know.

Q. Is he?

A. No, he is not.

Q. When did he lose the position?

A. He lost the position in the course of the last year.

Q. This particular document it says up top a CME.

Q. What is a CME?

A. That stands for continuing medical education.

Q. This is where doctors will go to hear other doctors speak on topics relevant to their practice?

A. That's correct.

Q. And the name of this document or this CME is Fertility, Mood and Motherhood?

A. That's correct.

Q. Do we know, in looking at the document, whether there was any GSK involvement in the material?

A. We do know that this material was prepared for Dr. Nemeroff, yes.

Q. By GSK?

A. Yes; and through them, agencies like STI, for instance.

Q. When I look at the -- when I actually look at the document, it's about 15 pages long, is there a place to put in this document, in this CME who were the people that wrote it or put it together or did the slides?

A. No, I think most doctors looking at this would assume it was prepared by Dr. Nemeroff.

Q. All right. If you can turn to Tab 23.

MR. TRACEY: This is Plaintiff's Exhibit 1661, Your Honor, which plaintiffs
will move to admit.

THE COURT: Wait a second, please. Going back to the other document for a second, sir, the last page, does not the document indicate that it was supported through an unrestricted educational grant from SmithKline Beecham Pharmaceutical?

THE WITNESS: Yes, it does.

THE COURT: Go to your next questions.

BY MR. TRACEY:

Q. That's on the last page of that document, Doctor, right?

A. Yes.

Q. To be clear, the last page of the document says that the materials were provided by SmithKline Beecham.

A. No, it says supported by unrestricted educational grant. That Dr. Nemeroff was reimbursed for his role in this.

Q. I see; okay.


----

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Thursday, September 24, 2009

**EXCLUSIVE - KILKER v GLAXOSMITHKLINE COURT DOCUMENTS

"Now, this particular type of drug we talked about during jury selection a little bit. It is called the selective serotonin reuptake inhibitor. That is actually a name that GlaxoSmithKline coined. They coined that phrase. You are going to learn they coined it because Paxil is the most selective, the most powerful of the serotonin reuptake inhibitors."


The documents are located on the Baum, Hedlund, Aristei & Goldman web page.


In the Court of Common Pleas, First Judicial District of Pennsylvania, Civil Trial Division

LYAM KILKER, a Minor, by MICHELLE M. DAVID, as Next Friend and Individually
VS.
SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE



9/15/09 AM: Opening Statements




Plaintiff’s Expert: David Healy, MD FRCPsych, Neuropyschopharmacologist, Professor of Psychiatry, Cardiff University,University Hospital Wales North Wales Department of Psychological Medicine

9/15/09 PM: David Healy, M.D. -- Direct Examination




9/16/09 AM: David Healy, M.D. -- Direct (continued)




9/16/09 PM: David Healy, M.D. -- Direct (continued); Cross Examination






9/17/09 AM: David Healy, M.D. -- Cross (continued); Redirect





9/17/09 PM: David Healy, M.D. -- Recross; Redirect






Plaintiffs Expert: Suzanne Parisian, M.D., former FDA employee


9/18/09 AM: Suzanne Parisian, M.D. -- Direct Examination




9/18/09 PM: Suzanne Parisian, M.D. -- Direct (continued)




Plaintiff’s Expert: Shira Kramer, Ph.D., Epidemiologist

9/21/09 AM: Shira Kramer, Ph.D. -- Direct Examination



9/21/09 PM: Shira Kramer, Ph.D. -- Direct (continued); Cross Examination; Redirect




Plaintiff’s Expert: Ra-id Abdulla, M.D.


9/23/09 AM: Ra-id Abdulla, M.D. -- Direct Examination





9/23/09 PM: Ra-id Abdulla, M.D. -- Cross Examination; Redirect



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

SEROXAT - COURT SETS DEADLINE FOR COMPENSATION CLAIMS








Advertisement from today's Guardian Newspaper, in the G2 television supplement section a couple pages before the TV listings on the left hand side.



UK Blogger's please feel free to disseminate.



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Wednesday, September 23, 2009

Paxil [Seroxat] Marketing Spin

WHAT THEY [GSK] TOLD THE CONSUMER.



ADVERT FOR PAXIL [2000]





ADVERT FOR PAXIL CR [2002]





WHAT THEY [GSK] FAILED TO TELL THE CONSUMER




WHAT THEY [GSK] SAID DURING THE 'GOOD TIMES' OF PAXIL SALES




FORMER GSK CEO, JP GARNIER, WALKS OUT OF BBC STUDIO AFTER BEING GRILLED ABOUT HIS COMPANY AND THE SUPPRESSION OF PAXIL TRIAL DATA



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Monday, September 21, 2009

GlaxoSmithKline's Dr Alistair Benbow

Dr Alistair Benbow GSK

1999 Quote regarding GSK's Requip



"...ropinirole was associated with sleepiness, but only in a tiny minority of patients, and that the company had never previously come across patients who experienced sudden sleep attacks"


10 years later...

Requip Safety Information.

Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)
Feeling sick (nausea).
Sleepiness (somnolence).
Difficulty performing voluntary movements, resulting in jerky or involuntary movements or muscle twitches (dyskinesia).



2004 Quote regarding GSK's Seroxat

"All of the safety data was submitted to the US and European regulatory authorities and was publicly presented in a timely way. In fact safety data from study 329 had already been submitted to the regulatory authorities and had been presented publicly before this document was written."


4 years later...

The MHRA spent four years looking at over one million pages of evidence to determine whether GSK had withheld information.

Professor Kent Woods, MHRA chief executive said they were disappointed GSK had not given them information earlier and that drugs firms had an "ethical responsibility".

"I remain concerned that GSK could and should have reported this information earlier than they did."



2007 Quote regarding GSK's Avandia after it had been suggested that Avandia almost doubles the risk of heart failure.

"...it was "well recognised" that this class of drug could cause fluid retention and the risk was "clearly stated" on its medication. This could be resolved if the patient was well monitored and prescribed diuretics ." [drugs that prevent water retention by promoting more frequent urination]


Article from Bloomberg in 2007

GlaxoSmithKline Plc was warned by U.S. regulators in 2001 against playing down the risk of cardiac disease associated with Avandia, the diabetes drug linked this week to an increased risk of heart attacks.

A year earlier, in March 2000, a diabetes expert from the University of North Carolina, Chapel Hill, wrote a letter to the Food and Drug Administration complaining about the company's ``rampant abuse of clinical trial data'' related to the drug's cardiovascular safety.



2007 Alistair Benbow reported to the General Medical Council [GMC]
Correspondence between Charles Medawar [Director of Social Audit Ltd] and the GMC.



1 February 2007
Dear Sirs,

I am writing to enquire about the possibilities and appropriate procedures for making a complaint about a registered medical practitioner, in circumstances which do not appear to be covered by the guidance given on the GMC website. I should be grateful for your advice about how to proceed, in the light of the following possibly complicating factors:

1. The complaint I seek to bring does not directly relate to standards of treatment or practice by the individual concerned. I am not a patient of the doctor in question, nor do I have reason to believe that he lacks qualities that would call into question his fitness to practice medicine in a clinical setting. My concern is about the conduct of medically qualified individuals in an institutional/organisational setting.

2. The subject of this prospective complaint is a well qualified physician who acted as the principal spokesperson for the manufacturers (his employers) of a widely prescribed antidepressant drug. I would wish to allege that, in that capacity, and on several occasions, he offered inappropriately reassuring advice about the safety profile (benefit-to-harm ratio) of that drug, in programmes broadcast on television (Panorama: BBC-TV), distributed worldwide. I would wish to allege [a] that his statements were (by omission and/or commission) inaccurate, misleading and possibly reckless; [b] that the statements he made did not reflect the evidence to which he had unique access, whether or not he availed himself of those data. (It is relevant to note here that some submissions to the UK drug regulatory authorities were made in his name); and [c] that substantial harm very probably resulted from his failure either to critically assess the evidence available to him, and/or to his presumption that there was no cause for concern.

In short, and in the light of the evidence that has since become publicly available, this man’s statements on television leave the impression that he conceived his primary duty of care to be to his employers, rather than to the many people (including health professionals) likely to have trusted his judgment as a doctor, and to have been influenced by the reassurances he gave. (Panorama has broadcast four programmes on this subject and this man was interviewed for the first two, but made appearances in all four). I believe that, in the UK, the audience for each of these programmes has been over 3.5 million viewers).

3. My status as a prospective complainant is untypical. The complaint I would wish to bring would and should be in my name – but in my professional capacity as a medicines policy analyst and reporter, with a particular interest in the marketing and effects of this (and related) medicinal products. Therefore it would also seem most appropriate to bring forward any complaint under the letterhead of the organisation (Social Audit Ltd) which employs me in this capacity.

By way of background information, I am enclosing a copy of the review posted to the Social Audit website of the Panorama programme broadcast on 29 January: www.socialaudit.org.uk now gets >750,000 visits/year.

I understand this review is to also be posted to bmj.com

I would welcome your advice on how best to proceed. Thank you for your attention; I look forward to hearing from you.

Yours faithfully
Charles Medawar
—————————————


From the GMC 22 February
Dear Mr Medawar

Your complaint about Dr Alastair Benbow

Thank you for your letter of the 1 February 2007.

The main statutory objective of the GMC is to protect, promote and maintain the health and safety of the public. One of the ways in which we do this is by maintaining the integrity of the medical register (on which all doctors wishing to practice medicine in the United Kingdom must be included) by ensuring that those doctors on the register are fit to practice and taking appropriate and proportionate action against those whose fitness to practise may be “impaired” (by virtue of misconduct, ill-health, performance, criminal conviction or regulatory determination). Should we continue with your complaint it would almost certainly fall within the misconduct category.

Your complaint appears to relate to statements made by Dr Benbow, in his capacity as head of European clinical psychiatry at GIaxoSmithKline, on two Panorama programmes in relation to the safety (benefit to harm ratio) of paroxetine (seroxat) on depressed adolescents and children. You have helpfully enclosed with your complaint a copy of a review of his and others comments made on the programme(s), which was posted to the Social Audit website following a broadcast of one of the programmes on the 29 January [2007].

In order for the GMC to determine whether Dr Benbow’s fitness to practise may be impaired by reason of misconduct we would need to consider the nature of the allegations you are making (taking into account all the circumstances of the case and our guidance in Good Medical Practice) and whether there is tangible evidence to support a finding of misconduct.

Whilst I appreciate that Dr Benbow’s comments have caused you concern, at present there is nothing in your complaint in its current form to suggest that his medical abilities are affected as a result of the comments you say he made. Therefore, if you wish the GMC to consider this matter further I should be grateful if you would provide me with further details of the allegations you are seeking to make against Dr Benbow, including specific details of exactly which comments you take issue with, when and in what context they were made, and why you take issue with them. If you have any documentation which would support your complaint, then I would be grateful if you could supply this. It would be of particular help if you could provide me with a videotape or DVD of the programmes in question if you are able to do so.

I look forward to hearing from you by Friday 2 March 2007.

Yours sincerely

Anna Neill
Investigation Manager


—————————————
From Charles Medawar 28 February 2007

Dear Ms Neill,

Thank you for your letter of 22 February. I’m sorry if I didn’t make it clear in my letter of 1 February that I was not so much bringing a complaint about Dr Benbow, as enquiring about whether and how to do so in the unusual circumstances I outlined.

I mentioned that my search of the GMC website yielded no guidance, nor obviously applicable case law, but thank you for telling me that allegations of misconduct would almost certainly best fit. However, I have checked the GMC website again and have found no pithy judgments, definitions or precise guidance about what misconduct might entail. I would therefore welcome any advice you might give about what might be relevant and appropriate in pursuing the issues in this case.

It might help to clarify these matters at the outset, because preparation of the case would involve me in a lot of work – and a great deal more by the GMC, if the case were to be investigated and pursued. What was said in the broadcast interview would need to be tested against substantial, sometimes detailed evidence, to establish how true, fair and appropriate it actually was. You will appreciate this from the recordings and transcripts of the programme I shall send you, though the gist is clear.

Dr Benbow publicly and emphatically denied the existence of risks with Seroxat® when his employers were in possession of evidence that those risks were substantial and real. The book, Medicines out of Control? gives a summary of events and context, through December 2003, and I shall send you this too. Meanwhile, Panorama specified two main problems:

1. Some users experienced severe and prolonged withdrawal symptoms and felt addicted to Seroxat®; they were unable to stop taking the drug when they very much wanted to. This problem was clearly significant: there were (and are) more such adverse drug reaction reports for Seroxat® than for any other drug. With apparent sincerity, but also quite deviously, Dr Benbow denied their significance. However, within three months of the second Panorama programme, GSK withdrew its claim that Seroxat was not addictive, and radically revised its previous insistence that withdrawal symptoms were rare and mild. They admitted (as they were required to do) that about one-quarter of all users would experience withdrawal reactions, some severely so.

2. Concern was expressed also about the risk of paroxetine-induced violence and self harm including suicidal behaviour, especially in children and adolescents. Again Dr. Benbow denied the available evidence, though a few weeks after the second Panorama programme, the UK regulators required Seroxat® to be contraindicated for use by under 18-year olds. Having seen the relevant data, it took them just two weeks to do so. Independent reanalysis of the original data in 2006 showed the risk for children to be greater still, and that a significant risk existed for adults too.

In my earlier letter, I alluded to the apparent complexity of the issues, but perhaps too obliquely. The prospective complaint is not primarily about Dr Benbow’s abilities as a clinician, the traditional concern of the GMC. Nor is it to do with traditional notions of professional misconduct. The complaint is also very much to do with context: what is proper, or ‘behaviour unbecoming’ or ‘misconduct’, when a doctor assumes responsibility for communicating to millions of people ‘the facts’ about the risks and benefits of using a specified drug, when he also has unique access to the unpublished and most relevant data?

Another complication is that it seems impossible to measure with any precision the health impact of Dr Benbow’s advice – arguably the key indicator of appropriateness of behaviour. My sense is that, if he had been free to reflect what he knew (or ought to have known), and to promote his beliefs and values as a doctor, [a] Dr Benbow would have been very much more circumspect and honest in dealing with Panorama; and [b] this would have spared many people significant injury, loss and distress.

It seems relevant to note that there would be no grounds for complaint about Dr Benbow, had he complied with the terms of the pharmaceutical industry’s codes of practice for drug sales representatives – e.g. “Information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all evidence and reflect that evidence clearly. They must not mislead either directly or by implication.”

In this connection, you should be aware that, between 2001 and 2003, Social Audit made two separate complaints to the ‘Prescription Medicines Code of Practice Authority’ about gross misrepresentation of risk of dependence by GSK staff. Both complaints were lodged before Dr Benbow’s appearances on Panorama, and both were upheld. As Dr Benbow represented GlaxoSmithKline at the second hearing, he would have been familiar with the issues – including those relating to definition. Dr Benbow’s statements in the first Panorama programme cannot be reconciled with the relevant WHO advice on this subject. See attached letter (20 May 2002) and specifically the section on the definition of ‘dependence’:

Since publication of the ICD-10 guidelines, the World Health Organisation (1998) has published a statement on “Selective serotonin reuptake inhibitors and withdrawal reactions,” which makes it clear: [a] that dependence should be regarded as not an ‘on or off’ phenomenon, but as a condition that should be measured by degree; [b] that on existing definitions, sensibly interpreted, SSRIs can and do cause ‘dependence’; and [c] that in the last analysis, the patient’s experience with the drug is the test of whether or not a drug causes dependence:

“There is obviously some confusion about the concept of dependence … The simplest definition of drug dependence given by WHO is ‘a need for repeated doses of the drug to feel good or to avoid feeling bad’ (WHO, Lexicon of alcohol and drug terms, 1994). When the patient needs to take repeated doses of the drug to avoid bad feelings caused by withdrawal reactions, the person is dependent on the drug. Those who have difficulty coming off the drug even with the help of tapered discontinuation should be regarded as dependent, unless a relapse into depression is the reason for their inability to stop the antidepressant medication.

In general, all unpleasant withdrawal reactions have a certain potential to induce dependence and this risk may vary from person to person. Dependence will not occur if the withdrawal symptoms are so mild that all patients can easily tolerate them. With increasing severity, the likelihood of withdrawal reactions leading to dependence also increases …” (WHO Drug Information, 1998)

Should this case be progressed as a formal complaint, I would need to refer to other relevant documents on the Social Audit website. In the meantime, I hope that the programmes, transcripts and other materials I am sending will help you to determine whether and how you would wish to proceed.

You will appreciate that my underlying concern is about the meaning of being ‘a doctor’, and about the extent to which the public should trust that status, and depend on professional commitment to procuring health and doing no harm. To what extent should the public trust a doctor, when substantial conflicts of interest are involved? Perhaps Dr. Benbow’s fitness to practice is less important than the principle of the thing. I am very much open to suggestion, more concerned about the effective resolution of these concerns than about how this is achieved. I look forward to hearing from you

Sincerely,

Charles Medawar
Director

Attachments: DVDs and transcripts of Panorama programmes, Medicines out of Control? and other relevant materials. The reply from the GMC indicated a reply might be expected “within a couple of weeks”. It took ten.
—————————————


From the GMC 11 May
Dear Mr Medawar
I am writing further to your correspondence about Dr Alistair Benbow. I am sorry for the delay in our response.

From the information that you have provided so far, we cannot identify any issues that would enable us to conduct an investigation into Dr Benbow’s practice. In the absence of any clear criminal or other regulatory proceedings relating to the research into, and/or production or marketing of, Seroxat, to which Dr Benbow can be directly linked, there is no information available to us which could amount to an allegation of misconduct capable of calling into question Dr Benbow’s fitness to practise.

We are also of the view that it would be disproportionate and/or premature for us to commence an investigation at this stage for the purposes of searching for information or evidence sufficient to make an allegation regarding Dr Benbow’s fitness to practise.

We do not have information sufficient to make (or support) an allegation that Dr Benbow’s fitness to practise may be impaired. Although our file in this matter is now closed, this will not preclude us from reconsidering this matter in future, should new information or evidence come to light, which indicates that Dr Benbow’s fitness to practise might be called into question.

Please find enclosed your DVD, as requested. We have not taken a copy.

Yours sincerely

Tim Cox-Brown
Investigation Officer
—————————————


From Charles Medawar 24 May 2007
Dear Mr Cox-Brown

Thank you for your letter of 11 May (Ref E1-6XK3V) in response to my enquiries dated 1st and 28th February. Thank you too for returning the Panorama DVD that I sent to Anna Neill. I received both on 18 May, several days after I had read the duplicate letter you sent to another complainant, Mr. Derek Brown. He posted your correspondence on the Internet, but you should know that I had no contact with Mr. Brown on this matter: these were independent complaints, albeit prompted by many of the same concerns.

I am now minded to post our correspondence on the Social Audit website (>1m visits/year), to allow others to decide whether my enquiry was handled appropriately. My view is that this response casts doubt on the General Medical Council’s own fitness for purpose. The response to date signals to me lack of competence, capacity, imagination, independence and commitment to health, though in what proportions I can’t be sure.
I was struck by the emptiness of your letter. Everything you wrote emphasised that the GMC believes nothing can or should be done. The available evidence was sufficient to persuade Panorama to complain that Dr Benbow, representing himself as expert, had broadcast false and misleading statements about the safety of Seroxat (paroxetine). Yet the GMC seems unconcerned.

Is this really in the public interest, and in line with public expectations of the GMC? I very much hope not. It seems absurd that the GMC should be satisfied with the conduct of a registered medical practitioner, even when he/she falls short of pharmaceutical industry standards for drug sales representatives:
“Information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all evidence and reflect that evidence clearly. They must not mislead either directly or by implication.”

I bent over backwards to explain that I don’t have it in for Dr Benbow either as a clinician or personally but – along with many others – I am extremely concerned that any doctor should so uncritically toe the company line, when evidence of drug risk and harm is so strong. The generic issues seem critical: are doctors who speak for drug companies under too much pressure or otherwise professionally compromised? Are they simply to be regarded as company spokespeople, owing correspondingly less to the public by way of duty of care? It seems really feeble that the GMC should conclude so blandly, authoritatively and emphatically that there is nothing to be said, case closed.

The GMC’s position seems all the more unacceptable given that your President recently, if unwittingly, instigated an oppressive investigation of Professor David Healy, on the basis of ropey evidence and dark hints. On that occasion, a bit of deviously orchestrated and nasty gossip was sufficient for the GMC to require Dr. Healy to justify, in some detail, his fitness to practice as a doctor. I suppose it is to the GMC’s credit that they later concluded there was no case to answer; several major pharmaceutical companies would have been well pleased if this monstrous complaint had been pursued.

Here too, the GMC seems to have missed the point. Commercial influence now has profound effects on the ethos of medicine, clinical practice and patients’ health – some undoubtedly welcome, but others unquestionably not. If the GMC wasn’t concerned about the evidence from Dr Benbow, it would strike at the heart of evidence-based clinical medicine. I’d be reassured to think that, as a matter of urgency, the GMC was at least thinking about giving guidance on the subject – strong enough to protect the conscience of honest doctors employed by drug companies.

Both to protect Dr Benbow’s reputation, and to safeguard its own credibility, I suggest that the GMC should now state publicly [a] whether or not Dr Benbow was asked to respond to any allegations? [b] whether and in what manner Dr Benbow explained his position to the GMC? [c] whether or not the GMC accepted evidence from Dr Benbow that he had faithfully described the risks and harms of paroxetine known to him? [d] that the GMC was satisfied that the evidence of risks and harms of paroxetine that were uniquely available to Dr Benbow was satisfactorily communicated and [e] whether he explained to the GMC’s satisfaction that his performance on Panorama was sufficiently guided by the truth, the whole truth and nothing but the truth.

One should expect nothing less from an honourable doctor than from a witness in court, but where does the GMC stand? The question is not rhetorical, but nor am I prepared to fall in with the executive propensity for delay. If you or anyone else from the GMC were to pick up the phone within the next working day or two, I would sympathetically engage in any discussion relating to issues, publicity and engagement – even on off-the-record terms, if that were to serve some greater good. An alternative might be Judicial Review.

Yours sincerely

Charles Medawar
Director
—————————————


From the GMC 31 May
Tim Cox-Brown (0161 923 6427)
TCoxbrown@gmc-uk.org

Dear Mr Medawar

Thank you for your letter of 24 May 2007.

We are currently considering your comments and we will contact you again in due course.

Yours sincerely

Tim Cox-Brown
Investigation Officer


2008 Quote regarding GSK's Ziagen [abacavir]

"...the company takes any new information about the safety of its drugs seriously but it did not want to highlight what may be “spurious observations” relating to abacavir."

and

"GSK investigated the Uppsala signal in 2005 and carried out a check of its own internal data, as well as the database of the American Food and Drug Administration, but could not replicate the finding. “So there was not a signal in our internal database or that of the FDA,”



1 year later...

Researchers Show AIDS Patients Treated With Ziagen Are At Higher Risk Of Heart Problems




2008 UK solicitors, Hugh James, recieve a letter from Addleshaw Goddard [GSK's solicitors] regarding a video and comments made by me.




I removed the video from youtube.com but it has since been uploaded by another advocate.





My statement regarding Addleshaw Goddard's letter.


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.

----


Click here to watch Alistair Benbow discuss/defend Seroxat. [You will need Real Player to watch]


Alistair Benbow currently holds the following positions:


Vice President and European Medical Director
GlaxoSmithKline plc

Head of European Clinical Psychiatry
GlaxoSmithKline plc

Medical Director
GSK Europe

Related Link

The Magnificent Alistair Benbow in Full Flow


Fid

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