Zantac Lawsuit

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

Saturday, March 29, 2008

GSK Lawyers target Seroxat campaigner Bob Fiddaman

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.

Read full account in my book [links below]




Thursday, March 27, 2008

More from Paxil/Seroxat Online database

Here are more comments about Seroxat.

Taken from the online patient database -


Felt like nerve endings in anus and head were contracting for the first month, awful numbness in head, lifted my spirits but overall this drug is poison. Male 32

Only a mere 5mg/day. First 2 days: slight headache, feeling hazy and increased libido actually. 3rd day: severe depression, loss of concentration, anger, deep sadness, even suicidal thoughts weren't far. Stopped it at once(our best doc. remains ourselves) and fortunately I was(almost) back to normal the next day just some very little dizyness. Male 27

I have currenty been on this drug for over eight years and have decided that I have have had enough of sleeping for 13 hrs a day or more. When I started coming off this medicine I have been so sick. I have constant diarrhea, nausea and irritabiliy. I have this buzzing in my head. I can't stand to hear loud noises and excessive talking it drives me nuts. Female 36

Weight gain mainly, HORRIBLE withdrawl Male 51

Yawn tremors, vision difficulties, confusion, zombie-like, NO SEX DRIVE AT ALL. Female 26

No libido, constipation, weight gain, electrical zaps and swooshy sounds, suicidal ideation, rages, increased depression, agitation, the list goes on..... Male 31

Basically all side effects that are known. worse though, i got the tolerance/poop-out syndrome after a couple of years so i started withdrawing during use. withdrawal is the worst part of this poison! Male 31

COMPLETE LOSS IN SEX DRIVE! some weight gain at first, decreased effectiveness overtime, crazy dreams and night sweats, always sleepy (could sleep for 10 or more hours at a time!) Female 23

Tremors (all over body shakes, like really really bad case of the coffee jitters), insomnia--my brain was WIDE awake at 2 am--hot and cold flashes, I went from freezing cold to burning up in a matter of a minute, and when the hot flashes came, my skin felt as if it were being burned, it acted as a diuretic, made me have to go to the bathroom every ten minutes, and it made me really really nauseous. Female 35

Caused hands to tremble, perspiration/heat intolerance, brain fog, fatigue, insomnia Male 23

Excessive yawning, Dilated pupils, didnt care about things that used to bother me, I stopped obsessing over everything. The side effect that bothered me the most, was the sexual side effects. The desire was gone, completely, and inability to have an orgasm. It was horrible to not be able to have an orgasm! That was when I realized that i needed to stop taking Paxil. Female 26

Rapid weight gain, dizziness, memory loss, rapid heartbeat, loss of concentration, vertigo, nausea, decreased libido, ringing in ears, drymouth, difficulty sleeping, bad nightmares, spontaneous crying episodes Female 34

Turned into a zombie. Extremely sleepy during the day, can't fall asleep at night. Tried getting off it and experienced immense anger at everything. Short blackouts and "electric shocks" with accompanying flashes of light. Hot flushes (I'm male). Shaking, increased perspiration. Male 47

"The benefits of Seroxat far outweight the risks" - MHRA, DoH, GSK

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Wednesday, March 26, 2008

Lilly and state settle Zyprexa lawsuit

Yet another settlement out of court for Pharma.

When will some Lawyers take Pharma to the bitter end so they can actually find that they did wrong.

A settlement may be all well and good for those concerned but once again Pharma... in this case, Eli Lilly, have made no admission of any wrongdoing.

Earlier this month the MHRA slapped GlaxoSmithKline on the hand for holding back data that could possibly have saved childrens lives - it took them four years to scold the hand of Glaxo.

Now Lilly spare some loose change in this lawsuit.

It's a farce

Lilly and state settle Zyprexa lawsuit

Source: Anchorage Daily News

Eli Lilly and Co. and Alaska announced a $15 million settlement today in the state's lawsuit over the use of the drug Zyprexa in its Medicaid program.

The deal ensures that Alaska will be treated as well as any other state that may settle with Lilly over similar claims involving the drug, which is used to treat schizophrenia and bipolar disorder.

The agreement included no admission of wrongdoing by Lilly.

The state sued for hundreds of millions of dollars to cover costs to Medicaid for treating what it says are Zyprexa-related health problems, including weight gain, high blood sugar and diabetes.

The settlement ended a case in which jurors began hearing testimony on March 6. Lilly attorneys got a sense of the challenges they faced earlier this month.

Anchorage Superior Court Judge Mark Rindner said on the bench, without jurors present, that without lawsuits like the one the state of Alaska brought, claims that drugs cause health problems "might well go unaddressed."

Rindner was reacting to an assertion by Lilly lawyer George Lehner that drug regulation is up to the federal Food and Drug Administration, not any state. He argued that Alaska's Unfair Trade Practices and Consumer Protection Act shouldn't apply to drugs.

But Rindner said evidence presented by the state had established that the FDA "isn't capable of policing this matter."

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Tuesday, March 25, 2008

My Friend Arun Bhanot

Don't worry folks... Seroxat Sufferers hasn't sold out.

I've added a widget on the right. These are 8 songs written and performed by a good friend of mine from Walsall.

I've known Arun for many years and his talent deserves an airing. So please feel free to listen whilst you read through this blog.

Ladies & Gentlemen... Arun Bhanot

He's in the studio this week laying down six brand new tracks


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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



GSK South Africa - Rolling in it

Been a bad 12 months for GlaxoSmithKline - Avandiagate, Seroxatgate plus falling shares. Garnier will be leaving soon and Andrew Witty will become the new CEO. Surely Garnier cannot leave GSK in the mess that it is?

Step forward the women of South Africa.

On the 27th February this year a cervical cancer vaccine was given to go-ahead for use in South Africa.

Cervarix is manufactured by GlaxoSmithKline whose medical director Navin Singh said the registration was a great step forward, as more women developed and died of cervical cancer than any other type of cancer in South Africa.

Nothing like scarmongering before a drug is launched huh.

Singh added, “The decision to approve GSK’s cervical cancer vaccine represents a great step forward for all South African women. Physicians will now have access to this important vaccine to help protect women against this disease,”

Hats off to GlaxoSmithKline. Cancer is a bastard of a disease.

Let's roll forward now to the present day.

The South African public have just learned that the price for this treatment is a whopping R700 an injection.

The vaccine is administered in a series of three injections.

R700 is approx £43.50. ($86.85)

Multiply that by 3 and you have quite a bit of money - £130.50 ($260.55)

Some price to pay for a vaccine that can prevent a disease women may or may not get.

More here

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Paxil/Seroxat - Patient Database

This one goes out to Kent Woods, CEO of the MHRA.

It also goes out to MHRA Chairman, Alasdair Breckenridge, whom beleives the Seroxat scandal is 'rubbish'

Defective drug or patients being delusional?

Here are some of the comments left by patients prescribed Paxil/Seroxat.

Take note of the differing age groups.

Remember the MHRA and GlaxoSmithKline say that Paxil/Seroxat is fine to take if you are 25 years of age or over.

Info taken from

Weight gain, hunger, vivid dreams - Female 25

This is the worst medication to try and get off of. I felt terrible for days, depersonalisation, brain zaps, tingling, flu-like symptoms. - Female 36

electric "jolts" feeling in head, weight loss, anger - Female 35

Drowsiness, numbing of clitoris, difficult reaching orgasm - Female 48

Sleepy, no sex drive, emotionless. Cannot seem to get off of it, I have tried many times, end up getting sick. Has helped with the panic and anxiety though, which I had dealt with all of my life. Started taking it after experiencing a terrible tragedy, then noticed that it helped in other ways. Having done it again, I think that I would have asked for something less addicting. - Male 47

want to sleep all the time, sleeping 12+ hours, zombie like, out of it, nearly crashed my car a few times, mini-amnesia like episodes for a few seconds or minute when i come to i'm about to hit a car or something, dont feel like doing anything but veggin' out. Also from the first day had an on-set of wanting to eat all the time especially sweets and junk food... i normally have little interest in sweets... at this rate i'll become overweight in a couple of months - Female 33

Insomnia, Chattering teeth, feeling giddy, unable to concentrate, unable to sit still, floating feel when I walk, dilated pupils, cloudy thinking and the list goes on - Female 23

Paxil gave me a permanent neurological disorder - Female 37

For the first few weeks I had extreme fatigue (falling asleep at my desk, feeling very out of it, etc.) At 20 mg, the only side-effects I have now are mild fatigue (I'm okay if I'm at work or doing something, but if I'm at home I want to take naps frequently), and if I miss 2-3 doses I experience mild brain shocks and wooshy dizziness which disappear immediately after taking my next dose. Female 40

20 lb. weight gain, a little apathetic at times, sleepiness, bad withdrawal MUST taper down via liquid Paxil - Female 27

total zombie, vivid dreams to the extent that I could not differentiate between real and dream when i woke up, almost zero sex drive, total inability to orgasm, very frustrating, should not be sold, snake oil. Male 33

"EYE JERKS". Feels like electric zaps quickly pulling my eyes from side to side. I've just been weaned off the drug, and the eye jerks are much worse, though I had them while taking drug. - Female 59

Yawning, jaw chatters, dizziness, nausea, some brain zaps & vision disturbance. - Female 29

cloudy thinking, extreme fatigue, suicidal ideation, emotional numbness to everything, loss of interest and creativity, extreme depression, dizziness, vertigo, space-outs,...DO NOT MIX WITH ALCOHOL!!! - Male 25

sexual side effects including complete inability to orgasm, withdrawal symptoms are MISERABLE - Female 27

Chattering teeth & delayed orgasm. Male 39

There are over 500 comments on the page. Some are good but most are bad, in fact I'd hazzard a guess at 90% being bad.

Remember folks, the MHRA and GlaxoSmithKline tells us 'The benefits far outweigh the risks'

This patient information database suggests otherwise

Guess it's just a case of patients being delusional then huh?


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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Sunday, March 23, 2008

South Africa - running low on antidepressants

Thanks to Steph Gatchell for sending this on to me.

Medication shortage hits patients


A nationwide shortage of medications, including those used to treat chronic ailments like depression and schizophrenia, has pharmacists and patients on edge.

Manufacturers have been tight-lipped over the exact reasons except to say there is a global shortage of certain raw ingredients.

A Cape Town woman said she had battled to find her chronic medication for bipolar disorder, called Solian. Her Sea Point pharmacist said they had phoned everywhere but the whole of South Africa appeared to be out of stock. And a number of other medications, including some anti-retrovirals and anti-depressants, were also unavailable. "Eventually they found some of a much higher dosage which they cut up into quarters."

She said not to take the tablets for bipolar disorder was bad, but for people with schizophrenia it could be a disaster.

Cape Town psychiatrist Dr Jeff Mullan said reasons for the shortages appeared shrouded in secrecy and denial. "Everyone is passing the buck and there are all sorts of different stories."

Patients on drugs like anti-depressants couldn't simply stop taking them. They needed to be weaned off after completing the pre-requisite course which was usually six months to a year. "Those who are forced to suddenly stop could face side-effects."

Both the chemical and psychological dependency needed to be taken into account. "A person who suddenly has to stop can experience psychological panic, which can be as powerful and impactful as the chemical dependency."

Peter Eagles, president of the SA Pharmacy Council, said there could be many reasons for the shortages, including inadequate standards at facilities producing the drugs.

This was what caused the recent Disprin shortage, when Enaleni Pharmaceuticals was forced to upgrade its Durban facilities and there was a disruption in supply.

Many pharmaceuticals were produced in countries such as India, Iceland and Puerto Rico. Sometimes after inspections these facilities were closed down.

Eagles said competing markets and economics could also be contributing reasons.

A pharmacist at Dischem said the shortages had not only increased their workload but had annoyed customers who had to return to get their medication. "People on anti-depressants also can't just swap their medication, so they are getting upset."

Among the items out of stock at their pharmacies were the anti-depressant Trepeline, and Buto-Block for high blood pressure. One of their lines of anti-retrovirals was also in short supply, and there were shortages of cold and flu medication containing ephedrine.

The pharmacists said on one occasion robbers in Johannesburg had hijacked a truck containing more than 500kg of ephedrine, which is a chemical commonly used in the manufacture of cat and tik (methamphetamine). This had possibly contributed to the shortage.

A Johannesburg pharmacist said they were also experiencing several shortages of drugs at the moment. Aropax, an anti-depressant produced by GlaxoSmithKline, hadn't been available for some time while Molipaxin, also an anti-depressant produced by Sanofi Aventis, was "totally unavailable".

He said people on anti-depressants couldn't simply swap their medication for something else. "We also can't get Disprin or Codis. The manufacturers either say they are battling to get raw ingredients or there are problems with packaging."

A pharmacist in Tokai said since the end of last year they had experienced many problems with items being unavailable for weeks at a time.

"It is extremely frustrating because we are not told why there is a shortage. And it is not just a particular class of drugs but across the board."

She said it seemed to be getting worse daily. "Previously we were out of stock for maybe a week, but now it can be months."

Allison Vienings, the executive director of the Self Medication Association of SA, said there were many reasons for medicine shortages. "Sometimes the formula is required to change and these changes have to be approved by the Medicines Regulatory Authority."

An application for change had to be submitted and it often took some time to be approved. Manufacturers could also face a shortage of ingredients.

Mary Termets, of Sanofi Aventis, said they had been out of stock of the anti-depressant Molipaxin 50mg capsules since last year as a result of a global shortage of one of the raw ingredients, and were unlikely to get stock before the end of April. GlaxoSmithKline failed to provide reasons for the shortages, while Bayer did not respond to calls.

This article was originally published on page 5 of Cape Argus on March 22, 2008

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Friday, March 21, 2008


Nayer Khazeni, M.D.
Friday, March 21, 2008

This article appeared on page P - 5 of the San Francisco Chronicle

The CDC reports that antidepressant use by American adults tripled from 1988 to 2000, but two recent studies in peer-reviewed journals show that for the majority of these patients, the most commonly prescribed antidepressants work no better than sugar pills.

Is this information new? Yes and no. The investigators of these studies had to legally invoke the Freedom of Information Act to obtain and analyze unpublished trials on SSRIs (selective serotonin reuptake inhibitors - the most commonly prescribed class of antidepressants, which include Prozac, Zoloft and Paxil). They discovered the existence of a "file drawer effect" - trials with positive results are published while others are filed away - an issue that may confuse the true results of a great deal of medication research.

The January 2008 New England Journal of Medicine investigators found that 37 of 38 studies of antidepressants with positive results were published, whereas only 14 of 36 studies with negative or questionable results were. Even among those 14, many did not emphasize that suicidal thoughts and hopelessness persisted, highlighting, for example, improvements in sleep and energy, instead. The reversal of such "vegetative" symptoms (lethargy, insomnia and poor appetite) of depression in the presence of a continuing depressed mood is thought to play a role in the risk of completing suicide, and the FDA now requires all antidepressants to carry the most serious "black box" drug warning regarding possibly increased suicide risk.

The February 2008 Public Library of Science investigators, studying a different group of SSRIs, statistically analyzed the combined results of published and unpublished trials. Their findings added to several other studies showing that in all but the most seriously depressed patients, those who get better with antidepressants may also improve with placebos (sugar pills). This "placebo effect" is not unique to mental health treatment: From responses to placebo pills for the common cold to placebo operations for knee osteoarthritis, such improvements demonstrate the remarkable ability we have to heal our own minds and bodies without using pills.

If you're wondering about studies showing decreases in serotonin and other neurotransmitter levels in depressed or anxious people, be careful not to confuse those for evidence of a genetic basis for depression or anxiety or the need for a chemical solution. Serotonin levels can decrease in someone with no genetic predisposition to depression when he's upset about not having made partner at his firm, and can increase with just a few minutes of brisk walking. In fact, a wealth of data now verifies that depression and anxiety symptoms and biochemical markers improve with measures like exercise, meditation or talk therapies.

Before considering any therapy, be sure you and your physician have had enough time together to determine if you meet criteria for medical depression or anxiety (these disorders are closely linked, and antidepressant medications are used to treat both). Sadness or nervousness are not reason enough to begin a course of SSRIs or any therapy with multiple drug interactions and potentially serious side effects - those are normal human emotions, and in some cases, our bodies' protective warning signals to make a change in our lives.

Dr. Nayer Khazeni specializes in internal medicine and pulmonary/critical care, teaches and conducts research at Stanford University Medical Center.

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7





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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Thursday, March 20, 2008

Former GlaxoSmithKline Employee Speaks out

Can we trust information from drug companies?

Elizabeth Wager, freelance publications consultant, Princes Risborough

Thursday, 20 March 2008


GlaxoSmithKline will not face prosecution following an investigation by the MHRA into whether the company suppressed safety data about its antidepressant Seroxat (paroxetine). However, the report suggests GSK escaped criminal hearings mainly because the regulations on safety data disclosure were not clear enough.1

The rules will be tightened to prevent similar problems in the future, but, although this change is to be welcomed, it does not ensure that prescribers and policy makers will have access to all the information they need. Drug regulation in the UK (as in most countries) is carried out under an extraordinary cloak of secrecy. Data supplied by companies to the regulators is regarded as highly confidential. An ironic reminder of this appears in the MHRA report itself, which notes that “legal constraints make it impossible to disclose any information or evidence gathered during the course of the investigation.”

This should be of major concern to all clinicians. Evidence-based medicine requires reliable and complete evidence but if prescribers can read only what drug companies choose to publish, and unfavourable findings are suppressed, then the robustness of the evidence base must be questioned.

The GSK case should come as no surprise, and they are certainly not the only company guilty of not publishing unfavourable findings, since evidence of systematic publication bias has been available for decades.2 The Good Publication Practice guidelines for drug companies originally developed in 1999 call on companies to publish the results of all trials of marketed products.3 Drug companies are probably not the only culprits, and journal editors have been criticised for their unwillingness to publish negative findings. One response to this problem has been the creation of trial registers. The announcement by several major journals that they would only publish studies that had been properly registered (ie with details of the design posted on a public website before patients were enrolled) has acted as a major spur.4

Trial registration and prompt posting of results will become a legal requirement in the USA under the FDA Amendment Act which comes into force in 2009. But the journal requirements and American law apply only to current and future trials and to new drugs being licensed by the FDA; they will not correct the gaps in the evidence for the majority of medicines that are already licensed and are being prescribed today. Ironically, the European regulators already have a register of all the trials submitted by drug companies to obtain licences and fulfil post-marketing safety requirements. This goes back much further and is therefore far more comprehensive than, the register created by the US National Institutes of Health. Yet the EudraCT database, which could be such a powerful public health tool, remains inaccessible, with valuable data locked away, because it is considered commercially sensitive and therefore confidential.

While it may be acceptable for companies to keep their development plans for new compounds confidential, there is surely a strong ethical responsibility to publish results of all studies relating to drugs that are on the market. Not only should companies commit to publishing all such studies, they should also commit to publishing all the clinically relevant outcomes. Several studies have shown that selective reporting of favourable outcomes may be an even greater problem than non-publication of entire trials.5

Results databases linked to trial registers offer hope for the future.6 Comprehensive registers will highlight unpublished studies so, for example, people preparing systematic reviews can contact the investigators or sponsors requesting results. Electronic posting should also mean that results can be published easily and quickly, avoiding the problems of getting negative studies accepted by traditional medical journals. Linking the results with the outcomes stated in the original protocol should also reduce selective reporting.

Next time you see a representative from a drug company, ask about the company’s policy on trial registration and results posting, but perhaps more importantly, ask whether they have a policy to publish all studies for all their current products. Most of the major companies are ensuring they will comply with US legislation and many have created websites for posting results. That means we may have more confidence for an unbiased evidence base for drugs in the future – but as the GSK case shows, prescribing decisions for current medicines may be based on partial, and skewed, evidence.

Author’s competing interests: EW is an author of the Good Publication Practice guidelines for pharmaceutical companies and a former employee of GlaxoSmithKline


1. MHRA Investigation into GlaxoSmithKline/Seroxat

2. Chalmers, I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-8

3.Good Publication Practice guidelines

4. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Lancet 2004;364:911-2

5. Chan A-W, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ 2005;330:753.

6.Wager E. Publishing clinical trial results: the future beckons. PLoS Clinical Trials 2006;1(6):e31

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Wednesday, March 19, 2008

MHRA - "We see no point in answering questions where you have prejudged the veracity of any answers" THE INTERNAL REVIEW

So, as regular readers will know, the MHRA refused to answer a FOI request I sent them regarding their Chairman, Alasdair Breckenridge - they wrote me saying "We see no point in answering questions where you have prejudged the veracity of any answers".

I had asked three questions:

1. Was the MHRA Chairman, Alisdair Breckenridge unaware at the time of his statement on BBC TV's Panorama that the clinical trial results actually DID show that there was a high rate of suicide attempts in adults during the first ten weeks? If so, why?

2. Would Alisdair Breckenridge or the MHRA be prepared to now state that based on fresh new evidence, we believe that Seroxat DOES cause suicide in adults? If no, why?

3. As the Glenmullen report clearly shows there is a high risk of suicide in adults over the age of 25, do you think it reasonable that either Alistair Breckenridge or the MHRA publically apologise to all those patients and patients families whom have suffered at the hands of this drug?

The MHRA told me:

----- Original Message -----
From: MHRA Information Centre
To: fiddaman64
Sent: Wednesday, February 20, 2008
9:59 AM
Subject: RE: Suicide attempts

Dear Mr Fiddaman

We note that you have posted your 10 February email to us on your blogsite. You have chosen to headline it with “Dear MHRA... Re: Alisdair Breckenridge lying on national Television”.That headline makes it clear to any reader of your blog that you have already formed an opinion about whatever answer we might give you. It implies that you will not believe anything we say. That is consistent with the way you have responded on your blog to other answers we have given you in the past.

We see no point in answering questions where you have prejudged the veracity of any answers.

MHRA Information Centre


Well, as you can imagine I was not too pleased with a response like that so I recently asked for an internal review - once an internal review had been processed (and if I still wasn't happy) then I could write to the Information Commission and lodge a complaint.

So, the MHRA write back to me regarding the internal review:

----- Original Message -----
From: MHRA Information Centre
To: fiddaman
Sent: Tuesday, March 18, 2008
2:52 PM
Subject: RE: Internal review

Dear Mr Fiddaman

Thank you for your recent request for an internal review in respect of our reply to your enquiry (dated 10/02/08).

An internal review -in line with the Freedom of Information Act- is inappropriate in this case because the request was not dealt with under that Act. The Freedom of Information Act requires a public authority to consider the release of information it actually holds.

Addressing your request specifically:

MHRA doesn't record information relating to what an individual member of staff may or may not be aware of at any given time. In the absence of such a record, we are unable to provide you with this information.

The other elements of your request again, do not call upon us to consider information held, but rather to engage in further dialogue. Consequently, your request was handled outside of the Act.

Kind Regards,

Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000


So basically, they are now answering my original questions? (the three about their Chairman)

Quite why they didn't do this in the first place is quite perplexing.

So, if I'm correct the MHRA are saying that they DO NOT record information to what their members may or may not say? That's right isn't it? Or have I read it wrong?

They continue... "In the absence of such a record, we are unable to provide you with this information."

Ahem, Pardon?

Are they now saying they are not aware what their Chairman said on BBC TV's Panorama?

"...these drugs DO NOT cause suicide, they DO NOT cause suicidal thoughts in adults"

Did the MHRA miss this when it was aired?

Are they not aware that Breckenridge has also gone on record stating, when asked by investigative journalist Shelley Jofre if there may be criminal proceedings against GSK:

"That is a possibility"

At what point did the MHRA know that it would be indeed an impossibility to have criminal proceedings brought against GSK? (I've asked in a separate FOI request)

It would be interesting to learn if Breckenridge knew at the time when interviewed by Shelley Jofre.

Breckenridge has defended the use of Seroxat in adults at every given opportunity, he even went on record in the New Statesman:

"...This idea that the regulators have been hiding the data is just not true. The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish”.

Absolute rubbish eh Alasdair?

From the Glenmullen Report:

PIC 1 - 27 Year Old Woman

PIC 2 - 59 Year Old Man

PIC 3 - 56 Year Old Woman

PIC 4 - 38 Year Old Woman

The list is endless and more can be read HERE

Remember, these were all subjects used in the clinical trials of Seroxat.

So what does the Chairman of the MHRA have to say?

"This idea that the regulators have been hiding the data is just not true. The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish”.

Do you believe in Science Sir?

Do you believe in facts?

Do you take patient experience on board?

Or are the above 'absolute rubbish?'.


So, with the MHRA now basically answering my original question, it seems that I am free to 'prejudge the veracity' of any answers they may give me?

Would it not be the simplest of tasks to ask their Chairman whether or not he said what was aired on BBC TV's Panorama?

Did the BBC dub him?

The evidence is clear (God, I'm sounding like Benbow now) - Breckenridge has robustly denied any problem with Seroxat in adults. You are either blind, death or just in plain denial.

I of course, have forwarded my concerns onto the Information Commission.


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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Tuesday, March 18, 2008

A Request to the MHRA

One a request to get together to discuss matters, the other a request under the FOI.

Here is the email I have just sent them.

----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Cc: Charles Medawar ; David Healy ; Shelley Jofre; Janice Simmons ; Matthew Holford ; Derek D Scott ; Kent Woods

Sent: Tuesday, March 18, 2008 3:24 PM
Subject: MHRA warns the public to be vigilant - FOI Request

Dear Sirs,

I have copied in your CEO on this email, seeing as he refuses to even have the decency to acknowledge any emails I send him anymore.

I think it's high time the MHRA and anti Seroxat/SSRi campaigners got together to discuss the issue we have raised over the years don't you?

This emailing back and forth really is schoolyard stuff.

You have to admit you have been less than transparent with the campaigners and it seems no matter what evidence we supply in regard to the safety and efficacy of SSRi's in the adult population, you refuse to accept that anything is wrong.

Did you, as the Medicines Regulator not foresee any possible problems with Paroxetine?

Up to March 1997 you recieved 802 Yellow Card withdrawal Reactions relating to Paroxetine (see attached) and 9 reports of dependence. Paroxetine was introduced in 1991 and compared to Temazepam, Diazepam and Fluoxetine, which were all introduced much earlier, Paroxetine showed a far greater number of reports via your Yellow Card system. Did this not start alarm bells ringing?

Myself and others are finding it increasingly difficult to understand why the MHRA are refusing to budge on their stance that Seroxat in particular is safe for adults.

Janice Simmons runs the Seroxat & SSRi User Group. She tells me she has recieved over 15,000 emails, only two of which have anything good to say about Seroxat and other SSRi's. That is quite a significant statistic wouldn't you agree gentlemen?

You are supposed to be protecting the public and working with them and for them not against them.

The reasons why you are publically lambasted by myself and others is because we see that you are failing as a regulator. We see a conflict of interest and we see stubborness, particularly from your CEO, Kent Woods.

I want you to meet with us to discuss a possible way forward.

It takes up to 20 working days to answer a FOI request, 20 working days where patients are taking medication that is blindingly obvious is doing them harm.

My first request therefore is to set up a meeting with the CEO, Kent Woods. We want him to listen to what we have to say. We want to tell him where we think the MHRA are failing us... by us I mean the British public.

So, request number 1.

We request a meeting with your CEO, Kent Woods. Can you arrange this?

My second request is one I make under the Freedom of Information Act. It does not concern Seroxat or any other SSRi.

The request contains three questions.

I would like to draw to your attention your own website, in particular the following page: -

The subject matter is 'Dangerous practices in the unlicensed herbals sector'.

I read it with great interest particulary the case studies.

The following request is of particular interest and I'm sure you don't have to be Albert Einstein to figure out where I'm coming from with this request.

Case Study Number One on your page reads: "Two suspected adverse drug reactions reports have been received in association with in a multi-constituent Ayurvedic remedy, the product DBCare contained ingredients such as Trigonella foenum-graecum, Tinospora cordifolia, Syzygium aromaticum, Phyllanthus emblica."

My first question under the FOI is thus:

1. Were there only two suspected adverse drug reactions reported regarding the product DBCare?

Case Study Number Two on your webpage reads: "A man collapsed after consuming a product called Tian Li, which claimed to give sexual enhancement. He was also taking Viagra on prescription."

My second question under the FOI is thus:

2. Was this the only reported incident of an 'adverse reaction' regarding the product Tian Li?

Case Study Number Three on your webpage reads: "A woman who purchased a slimming product called Li Da Dai. She used this product for three days and felt a bit weak and vomited"

My Third Question under the FOI is thus:

3. Was this the only reported instance of an adverse reaction regarding the product Li Da Dai?


As I mentioned at the top of this email, your CEO, Kent Woods has been copied in on this email, it is entirely up to him if he wishes to personally respond. I have also taken the liberty of copying in some familiar names for you and ask you to take the request of a meeting very seriously.

A copy of this email will be published on the Seroxat Sufferers Blog

Yours sincerely

Robert Fiddaman

Seroxat Sufferers

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Coroner not happy with Seroxat

Source: North-West Evening Mail

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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




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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Another Isolated Seroxat Incident?

Man claims devil made him strike friend with metal bar

SOUTH BEND. Ind. (AP) - A man charged with striking another man in the head with a metal bar reportedly told police the devil made him do it.

According to a police report, 37-year-old Leo Wantuch III of Mishawaka told authorities the devil began controlling him after he started taking an antidepressant drug about six years ago.

Wantuch was charged yesterday with battery with a deadly weapon and released from jail on $2,000 bond pending a court hearing April 14th.

He is accused of striking 39-year-old Jeffery Slabaugh, a longtime friend of his.

Wantuch reportedly told police he wanted to draw attention to the effects of the antidepressant, Paxil. A telephone message seeking comment was left with GlaxoSmithKline, the maker of Paxil. There was no answer last night at a Mishawaka telephone number listed for Wantuch.

Copyright 2008 The Associated Press.

Hat tip to the Truthman for sending me this story.

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Man crazed by drink and Seroxat cocktail

Thanks to The Truthman for sending me this link.

Source: Oswestry Advertizer

A MAN who took anti-depressant tablets and then drank alcohol later proclaimed himself the Son of God in an Oswestry kebab shop.

Simon John Grover then announced he was on a mission to kill all Muslims as he was led outside the Leg Street premises just after 5.30pm last November 5, even though he later assured police that the owners of the Star Kebab Shop were his friends.

Grover, 43, admitted religiously aggravated behaviour when he appeared before Oswestry magistrates last week.

The court was told that people were looking very concerned when Grover was raging fairly incoherently outside the shop.

When he was put in a police car Grover had to be stopped from strangling himself with the rear seat belt.

In interview he later told police he had taken two anti-depressants and two pints of lager and the combination had 'made him go crazy.'

The people in the kebab shop had not wanted to make a complaint because Grover was a good customer but the incident had concerned passers-by.

Mr Paul Nicholas said that the Seroxat tablets kept Grover's depression under control but should not be mixed with alcohol.

He had already apologised to the kebab shop owners and did so again in court. He had been back to the shop as a customer on a number of occasions without any problems.

Grover was in breach of a two-year conditional discharge imposed for a social security benefit offence.

Mr Nicholas said that Grover had now changed his anti-depressant prescription.

Magistrates took no action on the breach of the conditional discharge and fined him £150 for the new offence and ordered him to pay £34 costs and a £15 victim surcharge.

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Baum Hedlund Wins Key Preemption Ruling in Collins Paxil Suicide Case


A Philadelphia has judge denied Paxil manufacturer, GlaxoSmithKline’s (GSK) motion to dismiss the claims of a family whose husband and father committed suicide while taking Paxil, in Collins v. SmithKline Beecham, d/b/a GlaxoSmithKline. The Honorable Allan L. Tereshko, Coordinating Judge, Complex Litigation Program, in the Court of Common Pleas, First Judicial District of Pennsylvania, Philadelphia County, on March 12, 2008, denied GSK’s motion for summary judgment on Federal Preemption grounds. Judge Tereshko stated in his order that he “rejects Defendant’s theory of preemption for a number of reasons.”

Notably, the court held:

“Defendant's position is clearly not sustainable. Federal law in question unquestionably places the duty upon the manufacturer and does not preempt a State's ability to allow one of its citizens to inquire into whether the manufacturer breached that duty.” (Order at p. 9)

The family is represented by the national law firm of Baum, Hedlund, Aristei & Goldman and the issue of preemption was fully briefed by the firm. Baum Hedlund currently has 13 cases pending in the Paxil Mass Torts Program (MTP) in Philadelphia, including the Collins case. For 18 years (since 1990), Baum Hedlund has been at the forefront of the SSRI litigation and has represented thousands of victims of Paxil injury and death including more than 100 individuals across the country in suicide and suicide attempt cases involving SSRI antidepressants, including Paxil, Zoloft and Prozac.

Baum Hedlund has successfully argued preemption in numerous cases, including Witczak, supra, 377 F.Supp.2d 726; Zikis v. Pfizer, Inc., 2005 WL 1126909 (N.D. Ill. 2005); Cartwright v. Pfizer, Inc., 369 F.Supp.2d 876 (E.D. Tex. 2005); Miles v. Pfizer, Inc., Case No. 03-731-C (M.D. La. March 31, 2005) (order without opinion); Szybinski v. Pfizer, Inc., Case No. YC 047439 (Los Angeles Sup. Ct. July 12, 2005) (minute order striking FDA Amicus Briefs and denying preemption); Steinberg v. SmithKline Beecham Corp. Case No. 1-04-CV-029096 (Santa Clara Sup. Ct. January 25, 2007).

Bobby Ray Collins was a fifty-four year old detective working for the Smithsonian Institute in Washington, DC. He was happily married to Plaintiff, Mary Collins and the father of two children, ages 19 and 32. In January of 2002, he was prescribed Paxil for stress-related depression. After ingesting Paxil for less than four weeks and within two weeks of a dosage increase, Bobby Collins committed suicide by shooting himself in the head in the family home. Bobby had no history of suicide attempts or suicidal ideation. He was prescribed Paxil by his gastroenterologist.

According to Baum Hedlund attorney Bijan Esfandiari: “Naturally, this is a significant ruling in the preemption battle and will benefit all of the plaintiffs in Pennsylvania's Mass Tort Paxil Program. We further hope that Judge Tereshko's scholarly decision will be relied upon as persuasive authority by courts in other jurisdictions.”

Robin McCall (
Media Relations Director
Baum, Hedlund, Aristei & Goldman,
PC 12100
Wilshire Boulevard,
Suite 950
Los Angeles, CA 90025
Phone : 310-207-3233
Fax : 310-820-7444

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



MHRA 'Nothing to add'

Here's a full length response from the MHRA to an email I sent them a day after they announced that GSK had been naughty for witholding clinical trial data... but they was not going to prosecute... because basically, they couldn't!

----- Original Message -----
From: MHRA Information Centre
To: fiddaman

Sent: Monday, March 17, 2008 2:29 PM
Subject: RE: MHRA Investigation - A Sham!

Dear Mr Fiddaman

Thank you for the email. We have nothing to add.

Kind Regards,

Central Enquiry Point Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000


See the full response and other MHRA correspondence in my book, links below.

Sunday, March 16, 2008


1. Senator who ask GSK for the missing 9 pages
4. Author of Seroxat Sufferers Blog
6. GSK's shit yourself thin diet pill
7. Minister who can get in a state when asked what the benefit of Seroxat is
9. Shelley, Scots investigator that will bite your ankles
13. Rob, the fomer Paxil activist from the States
14. Martin, Ghostwriter extrordanaire
16. Sir Alasdair ? Stuttering Imbecile when interviewed by Shelley Jofre
18. Former GSK employee, now Head of Licensing at the MHRA
22. Charles, the thorn in the side of the MHRA
23. CEO of the less than transparent UK regulator
25. Janice, Web author of the Seroxat & SSRi User Group
26. Gisela, the Brummie MP who signs EDM's for more televised cricket but not EDM's that question the safety of Seroxat

1. Company who never admit liabilty yet settle out of court
2. Derek, Co creator of the Seroxat Support Group
3. Colour of the MHRA's flawed card system
5. Seroxat down under
7. Paxil --------, forum set up by patients to help patients
8. Diabetes drug infamously known for causing heart attacks
10. It's wet for June at the MHRA
11. It's quite an experience for Matthew
12. Sugar pill effective for depression but no side effects
15. Former SKB Drug known to cause spinal damage
16. Son of Pinocchio
17. JP - French Bully
19. Seroxat in America
20. Mind altering antidepressant that can cause suicide and suicide ideation
21. Widely reported side effect during Seroxat withdrawal
24. President of GSK US and Trustee for The Childrens Health Fund

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Antidepressants - An Indian Perspective

Source: The Economic Times

We've come full circle
Mythili Bhusnurmath, TNN

Early this month, Western papers were full of reports of a new study that seemed to rubbish the use of anti-depressants. Research at the University of Hull showed new-generation drugs such as Prozac and Seroxat do not relieve depression any more than dummy pills or placebos.

If anti-depressants are not the cure they are meant to be and the only ones gaining from them are drug companies, what’s the alternative therapy now being favoured by many doctors? The answer: Talking therapy! In plain language, a shoulder to cry on, ideally a qualified one, but if not, time, empathy and a willing ear.

Let’s accept it, modern-day life with its tensions means we all have our moments of self-doubt, of feeling life’s not worth living any more. Usually these are fleeting moments and more often than not, except in cases of severe depression, a caring family, a good friend, a sympathetic ear is enough to shake off the blues.

Unfortunately, the atomised lifestyle of the West, and increasingly our metros too, means no one has the time to lend you a shoulder when you are down in the dumps. Everyone is in the rat race. From kindergarten admission (as parents in metros will tell you) to high school and beyond, the pressure to perform, do one better than your neighbour, is relentless. To say time is at a premium is an under-statement; people are working more, sleeping less, spending less time with family and friends. And even when they do pause to listen, they listen with their ears, not with their hearts and that’s no use to someone who’s distressed.

In such a scenario what do you do when you are feeling low? Why, pop a pill, of course! Fortunately drug companies in India are not allowed to advertise on television but that is not the case abroad.

The drug may not actually do you any good but as anyone who has seen the seductive power of the advertisement blitzkrieg unleashed by drug companies on television overseas will vouchsafe, it’s easy to persuade yourself. After all there’s no reason why something that turned that haggard, beaten-looking man/ woman into a smiling, raring-to-go person on TV will not do the same for you. So what do you do? Reach for that bottle of pills much like many in India reach for that tube of Fair and Lovely, or should that be Fair and Handsome?

Counsellors and doctors don’t have much time either. In a world where time is money it’s so much easier to prescribe a drug than listen patiently to a person’s ills, real or imagined, and medicate as a last, not a first, resort.

The 21st century is all about the search for quick fixes. Depressed? No problem! Have a Prozac! Is your child distracted and inattentive in class? No problem! He’s probably suffering from Attention Deficit Disorder. Give him some pills. Don’t trouble yourself asking whether he/she is inattentive because the class is so boring that it does not hold the child’s attention. Whether the emphasis on rote learning means it simply does not interest a child who is inquisitive by nature (as most children are before our system of education kills their enquiring spirit). Or ask why the same child who just cannot sit still in class can sit for hours in front of a computer or a video game, lost to the world.

The answers are all there, staring us in the face but they are too disturbing. They call for patience and for time and effort, none of which most modern-day parents/teachers/doctors or counsellors have. So pop a pill; it’s so much easier. Never mind if it often implies drug-dependency for life.

Hopefully, with the publication of the study, there will now be some effort to turn the clock back. The UK government has already announced a $350 million programme to train psychotherapists who will treat an estimated one million people for depression and anxiety over the next three years. Predictably the drug industry is unhappy. If more and more people turn to old-world remedies whatever will happen to the lifestyle medicines on which the industry makes a fortune?

For us in India, there’s a message in this. Before we go whole hog the western way, pause, reconsider. Call that long-forgotten friend/family member, rethink your work-life balance and never allow drug companies to advertise on television.

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Friday, March 14, 2008

Say No More...

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Dear Dawn Primarolo...


I ask: What is the benefit of Seroxat?

You answer:

Primarolo, obviously cannot get a grasp of the basic English language.

Nowhere in the letter does it mention what the benefit of Seroxat is.

She may also want to do her homework regarding the safety and efficacy because the age groups she claims that Seroxat works in is NOT in line with those at the MHRA!

May I remind her:

A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Taken from the following MHRA document

What chance do we have when

a, The Minister of State, Dawn Primarolo, cannot even get to grips with a basic question?


b, The Department of Health are not on the same page as the MHRA when it comes to the risk of taking Seroxat.

So what is it?





This isn't Family Fortunes you know. You don't get a prize for guessing the right answer.

I thought the MHRA wre evasive but fuck me backwards! Dawn Primarolo just takes the biscuit!

Now Dawn, What the fuck is the benefit of Seroxat?

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



MP 'John Lewis List' v Fid List

For explaination of John Lewis List - GO HERE

Air conditioning unit: £299.99/Leave Window Open FREE
Bed: £1,000/£200
Bedside cabinet: £100/£15 Charity Shop
Book case/shelf: £200/Don't have one
Bookcase/cabinet: £500/FREE off my sister
Carpet: £35 per square metre/£400 2 rooms + fitting
Carpet fitting: £6.50 per square metre/see above
Coffee maker/machine: £100/FREE, I make my own coffee
Coffee table: £250/No room in flat for a table
Dining armchairs: £150 each/No room in flat for dining room chairs
Dining chairs: £90 each/Eat dinner on my lap
Dining table: £600/No room in flat for table
Dishwasher: £375/Wash dishes myself, it keeps my feet firmly on the ground.
Drawer chest (5): £500/£25 from charity shop
Dressing table: £500/Don't own one
Food mixer: £200/My stomach mixes the contents of any food I eat
Free-standing mirror: £300/I own a small shaving mirror - £1.00
Fridge/freezer: £550/£99
Gas cooker: £650/Have electric cooker - £120
Hi-fi/stereo: £750/£199
Installation of new bathroom: £6,335/Council Property, Est Cost £300
Installation of new kitchen: £10,000/What?
Lamp table: £200/A lamp has a special table?
Nest of tables: £200/How many tables does one person need?
Recordable DVD player: £270/£35 Yamada (Cheap but it does the job)
Rugs: £300/Don't own any
Shredder: £50/An MP with a shredder? Thought they had laptops that went missing?
Sideboard: £795/Kinell! How big is this second home of theirs?
Suite of furniture: £2,000/ FREE, Had my sisters old one
Television set: £750/£120
Tumble dryer: £250/I use Fresh air
Underlay (basic): £6.99 per square metre/Came FREE with fitting
Wardrobe: £700/£25 from charity shop
Washer-dryer: £500/Washer dryer and a tumble dryer too? My machine cost £250
Washing machine: £350/What in the name of Bo Diddley!
Wooden flooring/carpets: £35 per square metre/Huh?
Workstation: £150/£40

Am I happy?

Yes, I don't have to take Seroxat anymore and I have never forgotten my roots.

MP's on the other hand...

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Pa. Judge Rules Paxil Labeling Suit Not Pre-empted

One small step for man...


A Philadelphia judge ruled this week that federal law can't pre-empt a state product liability claim centering around the alleged failure of the makers of Paxil to warn about increased risk of suicide.

Judge Allan L. Tereshko, the coordinating judge of Philadelphia Common Pleas Court's Complex Litigation Program, denied a defense motion for summary judgment Tuesday, ruling that the doctrine of federal pre-emption does not preclude the plaintiffs from arguing that GlaxoSmithKline failed to fulfill its duty to warn users of Paxil of an alleged association between the use of the drug and suicidality.

The defense argued that the plaintiffs should be precluded from making that argument in state court under implied conflict pre-emption, saying that allowing the state court action over the adequacy of the Paxil label would result in conflicts with the "FDA's exclusive authority to determine the content of the label," Tereshko said.

"Defendant asserts that such inquiry is precluded by federal law since the content of the drug's label is governed by federal law and the duty to supplement the label is somehow subsumed into the [federal Food and Drug Administration] regulatory scheme," Tereshko wrote. "Defendant's position is clearly not sustainable. Federal law in question unquestionably places the duty upon the manufacturer and does not pre-empt a state's ability to allow one of its citizens to inquire whether the manufacturer breached that duty."

Collins v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline is the first Paxil case scheduled to go to trial in the common pleas court's mass tort program.

Sol H. Weiss, a shareholder of Anapol Schwartz Weiss Cohan Feldman & Smalley and the plaintiffs attorney in Collins, said he is not aware of any other Pennsylvania common pleas court opinions dealing with the federal pre-emption issue in pharmaceutical cases since the FDA unveiled revisions to its prescription drug labeling requirements in January 2006 and unveiled the "pre-emption preamble," which said that FDA approval of drug labels pre-empts conflicting or contrary state law.

"The Philadelphia mass tort program has always been regarded as one of the finest in the country," Weiss said. "I think it's a very important signal."

Andrew Bayman, national trial counsel for GlaxoSmithKline's Paxil litigation, is a partner with King & Spalding in Atlanta and that firm's practice group leader for its tort litigation and environmental group. He said he believes this is the first Philadelphia pharmaceutical case addressing the federal pre-emption issue.

Bayman said that recently there have been more decisions in other jurisdictions in favor of pre-emption than there have been against pre-emption.

"There are cases on both sides of this. The recent trend has been in favor of pre-emption. We're obviously disappointed with Judge Tereshko's decision," Bayman said.

GlaxoSmithKline is prepared to take the Collins case to trial and present evidence that there were other stressors, along with pre-existing depression, that led to the suicide in that case, Bayman said.

There are 60 cases pending in the Philadelphia Paxil program, according to Stanley Thompson, the director of the Complex Litigation Center.

Weiss said he believes that Tereshko's decision shows that claimants injured by defective drugs or relatives of people injured by defective drugs can maintain their lawsuits in state court.

"This is a very hot area of litigation because the pharmaceutical companies want a free pass," Weiss said. "If these claims are pre-empted, then all these people who are injured won't have a right to recovery. ... The people here, all the people who took all these SSRIs, these antidepressant drugs, and committed suicide, and families can't seek redress."

Tereshko said that it was not Congress' intent for federal law to pre-empt state causes of action and that the Federal Food, Drug and Cosmetic Act is silent on that issue. He noted that congressional hearings leading up to the passage of the Federal Food, Drug and Cosmetic Act included the decision to not include a provision for a federal cause of action because common law rights of action existed.

Bayman said GlaxoSmithKline's position has reflected the FDA position at the time that there was no scientific basis for the Paxil-suicide correlation allegation. Putting such a warning on the drug would thus violate federal law, he said, and a state court lawsuit determining that the warning should have been different would conflict with federal law.

Tereshko dismissed the defense's argument that use of beneficial drugs could be discouraged if they were mislabeled with warning information not based upon scientific evidence of known risks. He concluded such an argument is putting language into the federal law that is not there.

Bayman countered in an interview that the FDA has the exclusive power and authority to approve drugs as safe and to label those drugs with warnings. The FDA has warned of the dangers of "overwarning," he said.

"You run the risk of deterring people from seeking treatment or doctors from prescribing [drugs]. In this context, we know scientifically depression is seriously underreported ... because there's a stigma associated with treatment," Bayman said. "To put warnings on -- which some people say would only be on there to insulate manufacturers from liability -- if that warning is not based on good scientific evidence, that really runs the risk of deterring people from seeking treatment. That's why the FDA's job is to strike a balance."

GlaxoSmithKline also has a statute of limitations motion pending in the Collins case, Bayman said.

Tereshko also granted a plaintiffs' motion to strike amicus briefs filed by the FDA in similar federal lawsuits, which were submitted by the defense. The FDA had submitted amicus briefs in some SSRI litigation arguing that agency regulations pre-empt state tort claims over labeling requirements. The judge said that the briefs are hearsay documents under Pennsylvania law.

In one of the FDA amicus briefs submitted for Tereshko's purview, according to the judge's opinion, the FDA argued: "'Although FDA has the deepest sympathy for the plaintiff because of the loss of his wife, it is vital to ensure that state tort law does not undermine FDA's authority to protect public health through enforcement of the prohibition against false or misleading labeling of drug products in the Federal Food, Drug and Cosmetic Act. ... To base a tort judgment on a drug manufacturer's failure to warn in October 2003 of an association between adult use of paroxetine hydrochloride [Paxil] and suicide or suicidality, despite FDA's judgment at the time that there was not reasonable evidence of such an association, would be to demand a warning statement that would have been false or misleading, and thus contrary to federal law. In such a case, federal law must prevail."

The 3rd U.S. Circuit Court of Appeals heard arguments in December on two conflicting lower court cases over whether plaintiffs should be pre-empted from suing over allegedly inadequate warnings on prescription drugs because the FDA approved the warning labels.

U.S. District Judge Michael M. Baylson in the Eastern District of Pennsylvania held in Colacicco v. Apotex Inc. -- citing the FDA preamble -- that such claims are pre-empted, and U.S. District Judge Jerome B. Simandle in the District of New Jersey held in McNellis v. Pfizer Inc. that the claims aren't pre-empted.

The U.S. Supreme Court is slated to take up a pre-emption case, Levine v. Wyeth. Weiss said the 3rd Circuit may wait until the Supreme Court's ruling to decide its conflicting federal cases.

In the instant case, the survivors of Bobby R. Collins have brought a claim against GlaxoSmithKline, alleging that the Paxil prescribed to Collins for stress-related depression did not have an adequate warning of possible suicidality from taking the drug, according to Tereshko's opinion. Collins committed suicide Feb. 14, 2002.

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Wednesday, March 12, 2008

Question Sent to the MHRA

----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Cc: ;
Sent: Wednesday, March 12, 2008 2:32 PM
Subject: Question re - GSK Investigation and Outcome

Dear MHRA,

Seeing as GlaxoSmithKline conducted itself in a manner that is not in the interests of the patient, will the MHRA continue to accept funding from them?

If yes, Do the MHRA think this is morally correct?
If no, Could you explain why?


Bob Fiddaman

Seroxat Sufferers

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



New EDM Tabled Condemning the MHRA

Early Day Motion

EDM 1147


Flynn, Paul

That this House deprecates the gullibility of the Medicines and Healthcare Regulatory Agency (MHRA) in assuming that GlaxoSmithKline (GSK) would observe high ethical and scientific standards above its own financial interests in promoting the drug Seroxat; is astonished that the MHRA spent £1 million in their dilatory four year investigation of the drug before establishing that the law does not require GSK to report the ill-effects of Seroxat in children; is alarmed at possible conflicts of interests as the MHRA Chairman and several senior employees have been paid to work for and with GSK and that five of the 20 members of the MHRA oversight body currently depend on research grants from GSK; and calls for the establishment of a fully independent regulatory body free from the funding, influence and control of the pharmaceutical industry.

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Childrens Health Fund & David Stout of GSK

The Childrens Health Fund is committed to providing health care to the nation’s most medically underserved children and their families through the development and support of innovative primary care medical programs, response to public health crises, and the promotion of guaranteed access to appropriate health care for all children.

One of the Trustees?

GlaxoSmithKline, David M. Stout, President, Pharmaceuticals.

David Stout on Paxil/Seroxat

GSK strongly stands behind the safety and efficacy of Paxil. Physician organizations, like the American Psychiatric Association, have stated that antidepressants are not habit-forming.

David Stout President of U.S. Pharmaceuticals, GlaxoSmithKline

GlaxoSmithKline is proud to offer physicians Paxil CR the latest treatment advance in the SSRI class.

David Stout President, US Pharmaceuticals, GlaxoSmithKline4/19/2002

We are pleased that Paxil is now approved to treat an even broader range of anxiety disorders.

David Stout, President of U.S. Pharmaceuticals, GlaxoSmithKline

You need to talk to the patients. Things like restless leg syndrome can ruin people's lives. It is easy to trivialize things when you don't have them. If people did not want the treatments, they would not seek them. (HERE)

David Stout, President of U.S. Pharmaceuticals, GlaxoSmithKline

Maybe the Childrens Health Fund need to be sent a copy of the letter MHRA CEO, Kent Woods, sent to GSK CEO, JP Garnier?

Dear Dr Garnier

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

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

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

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

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

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

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

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



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