Zantac Lawsuit

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

Friday, February 29, 2008

GSK Reality Check - World Premiere

The following video is not my work. It was sent to me by a fellow sufferer of Seroxat. They too have had enough of GlaxoSmithKline and the MHRA.

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



You ever wondered why JP Garnier looks smug?

I've often wondered why GlaxoSmithKline CEO, JP Garnier looks remarkably smug for someone faced with so much shit. Falling shares, bad drugs, shedding his workforce, recent bad press regarding impartial studies etc.

Maybe the huge salary he demands is enough to keep him smiling through? Or maybe it is the knowledge that no matter how many Members of Parliament sign EDM's or voice their constituents feelings in the Houses of Parliament, he knows deep down that his close friendship with PM Gordon Brown will safeguard him.

Seroxat & SSRi User Group Founder, Janice Simmons, met with Gordon Brown last year, she asked him:

I am sure you are aware that GSK are being investigated for withholding information regarding seroxat being dangerous for children in that it caused self harm/suicide, which led to the drug being banned for under 18’s in 2003.

Can you please tell us why the MHRA are holding this investigation and why it has not been passed to the CPS? Why it has been 4 years since the investigation was instigated and still no conclusion?

We have in our possession a letter from SmithKline Beecham dated 1995, which reads: ‘with regard to behavioural side effects associated with Seroxat, you may be interested in the following information relating to emergence of aggressive behaviour and also of agitation with Seroxat.’

Gordon Brown replied "this investigation is being treated as a very serious investigation and I understand that over 1 million documents are being looked at. If GSK are found guilty prosecutions could be made.’

It's hardly endearing stuff from Brown is it?

Do we really think anything will be done?

How can we beleive that it will.

Let's see what I'm driving at here:

PM announces make-up of new Business Council

The Prime Minister has announced the creation of a Business Council for Britain comprising senior representatives of UK-based businesses, to advise him on issues that affect enterprise, business and the long term productivity and competitiveness of the economy.

The Council will be chaired by Mervyn Davies of the Standard Chartered Bank and will be attended by the Prime Minister and Secretaries of State of the main economic departments will attend. Other Secretaries of State will attend the meetings at the invitation of the Council.

The full list of members of the council is:

Sir Richard Branson: Founder, Virgin Group
Damon Buffini: Managing Partner, Permira
Sir William Castell: Chair, Wellcome Trust
Mervyn Davies: Chairman, Standard Chartered Bank
Sir Rod Eddington: Director, News Corporation
Dr Jean Pierre Garnier: Chief Executive Officer (CEO), Glaxo SmithKline
Stephen Green: Chairman, HSBC
Tony Hayward: CEO, BP
Sir Terry Leahy: CEO, Tesco
Sir John Parker: Chair, National Grid
Sir John Rose: CEO, Rolls Royce
Stuart Rose: CEO, Marks and Spencer
Arun Sarin: CEO, Vodafone
Dame Marjorie Scardino: CEO, Pearson
Sir Alan Sugar: Chair and CEO, Amstrad

Need I say anymore?

The gravy train keeps rolling and rolling.


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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Drug Profits A Bitter Pill To Swallow...

Source: The Daily Record

Feb 29 2008 Annie Brown

IN the futuristic world of Sixties movie Barbarella, instead of sex they took a pill and held hands "until full rapport" was achieved.

In the western world, in the here and now, we don't indulge in emotional problems, we take a pill.

Barbarella's pills were "exaltation transference pellets", ours are Prozac or Seroxat and we take them until "mood enhancement" is achieved.

And just like Barbarella's little pellet, it turns out, our pills could be the stuff of fantasy.

In 2006, the NHS issued 31million scripts for Prozac in the UK.

Anti-depressant prescriptions cost the health service £3.3billion last year, almost three per cent of the entire NHS budget.

But research has surfaced that claims they have little effect on mild depression and we may as well have lifted the mood making paper chains with all that cash.

Some of the data is 20 years old, gathering dust until some pesky researchers made the drug firms fess up through Freedom of Information Legislation. It's not that the drug companies lied, heaven forfend, just that they didn't tell the whole story.

Drug companies don't need to reveal the findings of all their tests, which is why they are able to put profit before patients.

In the meantime, the drugs were over-prescribed, billions of pounds wasted and lives ruined.

There's no little pill to cure that heap of waste and misery.

One of the most popular, Seroxat, has made the drug companies billions and though it might not have much effect on depression, it's adverse impact on lives has been huge.

It has been linked to suicides and the withdrawal symptoms can be horrendous.

A male friend of mine couldn't sleep after the breakdown of his marriage and took Seroxat on his GP's promise that it was not addictive.

Yet when tried to wean himself off it, his eyes became soulless, his mood dark, he sweated, his head pounded with pain and cloudiness and he felt he couldn't cope.

It took him five years to free himself from the shackles of Seroxat but he will be on an alternative anti-depressant for life.

When I burst in to tears in the doctor's surgery after the break-up of a long-term relationship, he offered me first Valium and then Prozac. Valium was the drug I remember made Seventies housewives' eyes glaze over and was as repugnant as flares.

Prozac? Well, I am the Prozac generation.

I looked at that box and could never bring myself to open it, I feared that inside it lurked a dependency that would linger long after my tears had dried.

The truth was that I wasn't depressed and I never have been.

I had been hit by one of life's curve balls and with some exercise, TLC and a new bloke, I got over it.

Not all problems are indicative of a medical condition, sometimes that's just life.

Depression is real, it's destructive and debilitating but curing it takes more than a course of pills.

Yet our psychiatric services are pitifully underfunded, inaccessible unless you stand on the Kingston Bridge and threaten to jump off.

The drug companies have us in a stranglehold.

If they had any conscience, they would hand over their profits to contribute to more psychiatric help.

The happy pills worked for them but were a con for those who needed them.

Now that is depressing.

'Drugs were over-prescribed, billions of pounds wasted and lives were ruined. There's no little pill for that heap of waste and misery'

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Makers of Sugar Pills Disappointed With Findings

Wally Winka's Sweet Factory, the makers of popular dummy pills, (Placebos) said they were 'disapppointed' at the recent study regarding antidepressants being as effective as their product.

A recent study showed that a huge meta-analysis of 47 published and unpublished clinical trials of five well-known anti-depressants, including Prozac and Seroxat, suggested that only a small group of severely depressed people stand to benefit from them. In other words, most patients might as well be swallowing placebos.

A spokesperson for Wally Winka's Sweet Factory told a packed press conference, "We beleive that this study may have caused unnecessary alarm and concern for consumers of our placebos." He added, "Our placebos have benefited millions of people worldwide".

Dr Alistair Crippen, Head of Safety at Wally Winka's Sweet Factory, said, "The evidence, however, is clear, these placebos are not linked with suicide, these placebos are not linked with an increased rate of self harm." He went on to say, "We are not misleading our consumers. The information on the placebo packets and in the information we supply to retailers, is based on fact."

CEO of the regulator who monitors the food we Brits consume, Prof. Kent D' Nial, told us, "The safety of the Wally Winka's placebos is kept under close continual review by us."

Wally Winka himself protested 'There has been no reports of side effects with our placebos, unlike the many reports for the antidepressant Seroxat, okay consuming our products may cause weight gain but compared to Seroxat we feel our brand of placebos has been wrongly condemned. Our placebos do not cause the following: Allergic reaction, chills, face edema (abnormal amount of fluid in the facial tissue), infection, moniliasis (infection caused by Candida (yeast like fungi), neck pain, overdose. Cardiovascular: Bradycardia (abnormal slowness of the heartbeat), conduction abnormalities (abnormal transfer of sound waves, heat, nerve influences, or electricity), ECG abnormal, hypotension (lowered blood pressure), migraine, ventricular extrasystoles (a premature contraction of the heart)."

He continued, "Neither do they cause Acne, alopecia (absence of hair from the body where it is normally present), dry skin, ecchymosis (blood under the skin, usually looks or appears like a bruise), eczema (an inflammatory skin disease characterized by lesions varying greatly in character, at times watery discharge and the development of scales and crust), furunculosis (a number of painful nodules formed in the skin, caused by bacteria, which enter through the hair follicles or glands, its formation is favored by digestive derangement and local irritation), herpes simplex, urticaria (reaction of the skin to certain drugs, marked by the appearance of smooth, slightly elevated patches, which are redder or paler than the surrounding skin and often includes severe itching)."

Winka paused for breath before adding, "To my knowledge our placebos will never cause Bruxism (grinding of the teeth especially during sleep), buccal cavity disorders (cavity running from the cheeks to the lips), dysphagia (inflammation of the esophagus), eructation (the act of belching or casting up wind from the stomach), gastroentertitis (inflammation of the stomach or intestines), gastrointestinal flu, glossitis (inflammation of the tongue), increased salivation, liver function test abnormal, mouth ulceration, vomiting and diarrhea, rectal hemorrhage."

"More so", he continued, "do they cause Anemia, leukopenia (reduction in the number of leukocytes in the blood), lymphadenopathy (disease of the lymphnodes), purpura (condition charactized by the presence of blood just under the skin, can appear any where over the body), WBC abnormality (white blood cell abnormality)?"

Finally, Winka added, "To tar our placebos with the same brush as a product that has had reports of Akinesia (the temporary paralysis of a muscle, can include intense pain), alcohol abuse, amnesia, ataxia (failure of muscular coordination or irregularity of muscle action), convulsion, depersonalization, hallucinations, hyperkinesia (abnormally increased mobility, abnormally increased motor function or activity), hypertonia (a condition of excessive tone, tension or activity, can include increased blood pressure), incoordination, lack of emotion, manic reaction, paranoid reaction, and thinking abnormal is, I beleive, totally wrong"

He ended his statement with, "Our placebos have brought joy to millions of people worldwide and do not carry the same risks of taking antidepressants"


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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Thursday, February 28, 2008

MHRA 'No Teeth & Not Motivated To Bite - 2004

The drugs industry and its watchdog: a relationship too close for comfort?
Rob Evans and Sarah Boseley
Monday October 4, 2004
The Guardian

It would appear to be a happy and satisfying relationship. "Our priorities are aligned," says one document. There have been "notable successes" says another, citing "another example" of where the two sides "cooperated well". In business partners, this would seem to indicate a harmony of views. The documents obtained by the Guardian, however, relate to meetings between the drug industry and the watchdog body set up by government to police it. Critics say the drug regulator and the industry are too close. Their proceedings have long been shrouded in secrecy because of the drug companies' insistence on the commercial sensitivity of information relating to their products.

Today, documents obtained by the Guardian under the open government code reveal the reality of relations between the Medicines and Healthcare products Regulatory Agency (MHRA) and the trade association of the industry it regulates. The documents show that:

the regulator and the industry have been engaged in a joint lobbying campaign in Europe;
the industry privately drew up its own detailed blueprint of how the MHRA should be run;
the industry has been pushing for higher level representation at the MHRA against ministers' wishes.

Since 1989, when the then prime minister, Margaret Thatcher, took drug regulation out of the hands of the Department of Health, the MHRA has been 100% funded by the pharmaceutical companies.

The MHRA's chief executive, Kent Woods, appointed in January, has no drug company background, but critics say the agency continues in the unquestioning belief that the regulator and the industry are working together in the mutual interests of public health.

John Abraham, professor of sociology at Sussex University, who is well respected for his books on drug regulation, says that in 1989 there was a reconstruction of the regulators' mission alongside the new fees relationship. The MHRA came to believe the interests of public health are coherent with the promotion of the industry.

"The criticism of the old Department of Health medicines department in the 70s was that it didn't have any teeth. Not only does it now not have any teeth, but it is not motivated to bite," he said.

The MHRA told the Commons health select committee inquiry into the influence of the industry that it does not consider the fee relationship to be a problem.

"I would suggest to a lay person there is a big problem with the concept of independence from industry of a body that is fully funded by industry," said Professor Abraham. The UK's regulatory agency competes with those of other countries to approve drugs for the whole of Europe.

But Professor Woods says that neither industry funding nor close liaison is a problem. "It is important that the regulator understands the regulated industry.

"I have to say that our areas of overlapping interests are not 100%. There are some things where we have common cause but our prime responsibility is to ensure we protect public health. These are aims which the industry shares. I don't think there is a necessary antipathy between what the ABPI [The Association of the British Pharmaceutical Industry] is trying to achieve and what we are trying to achieve. But there are other areas in which we can't agree."

Richard Ley, spokesman for the ABPI, denied that the ABPI had the MHRA "in its pocket". "The objective of the MHRA is to ensure that medicines are assessed to be effective and as safe as possible. Those are also our aims. We have an absolute desire to have good quality medicines."

The documents record the regular meetings and dinners between the MHRA and the ABPI over the past year.

Among the "notable successes" of its close collaboration with the industry, the MHRA paper cited how it "cooperated well" with the trade association to lobby other European governments and the European commission on a review of legislation governing drug companies. It was, according to the briefing paper, "another example where the Association of the British Pharmaceutical Industry and the MHRA worked closely together".

Minutes of a meeting between the ABPI and senior MHRA officials in April record that the "ABPI thought there was a remarkable concordance between MHRA and their priorities..."

At their meeting with the MHRA top officials in June, the ABPI presented an eight-page blueprint detailing how it thinks the MHRA should be run to "build upon the excellent working relationship" between the industry and the regulator. According to this document, "our priorities are aligned [ABPI/MHRA]".

Following this meeting, Nicky Lilliott, the ABPI's head of regulatory affairs, wrote to Professor Woods, to confirm that, as agreed, the ABPI would develop an action plan to discuss a wide range of issues for the future of the agency. "I would propose that over the summer the ABPI drafts an action plan and this is then circulated to yourself and colleagues for comments, with the intention to agree the action plan at our meeting in September."

"The action plan would need assigned topic leaders, joint ABPI/MHRA, in order to achieve the agreed objectives/milestones. The main driver for the actions and timelines for these issues will be the implementation (of) the new pharmaceutical legislation by October 2005". Professor Woods said the action plan related to establishing a framework for bilateral meetings. The documents show the ABPI is unhappy at proposed changes to the structure of the MHRA. It used to have three people on the ministerial advisory board and two on the Medicines Commission, the drug licensing appeal body.

In a letter to Professor Sir Alistair Breckenridge in January, Dr John Patterson, the ABPI president, wrote: "We remain concerned at the lack of representation of the pharmaceutical industry at board level within the MHRA ... As the only regulatory agency that is fully industry-funded, we believe it is essential that we have a say on a variety of issues, not least financial matters relating to fees and service levels."

After more pressure, MHRA officials discussed alternative arrangements. Roy Alder, a senior MHRA official, suggested in March that "there could be scope for industry to make a similar input to MHRA business and operational policy" through other ways. He wrote: "Ministers are clear that the MHRA board should have no current industry people. There seems no option on this issue." He suggested someone recently retired from the industry could possibly be put on the board, "but ministers may want to avoid any perception of industry interests at board level."

The Committee on the Safety of Medicines (CSM), made up of independent experts, advises the MHRA on which drugs to license after studying clinical trial data on safety and efficacy. Its members are supposed to declare any sponsorship or payments they receive for lectures or advice from industry. The last complete declaration of interests of CSM members, for 2001, shows 17 out of 36 members had personal financial links to the industry, while others have declared non-personal interests such as research grants.

The documents show that industry has been agitated about ministers' "unrealistic" plans to tighten the rules on conflicts of interests. The ABPI complained ministers were "being too restrictive in the requirement for experts to not hold any personal interests in the pharmaceutical industry."

Professor Abraham claims there is too much of the "revolving door" syndrome at the MHRA. Not only do CSM members take fees from industry, but many agency officials used to work for drug companies, such as the former head of worldwide drug safety at GlaxoSmithKline, who is now the MHRA's head of licensing.

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Do the MHRA just not give a toss about children

This from the Food Commission.

Food additives linked to hyperactivity are still being used in children's medicines, a new survey by The Food Commission has found.

The Food Commission looked at 70 prescription and over-the-counter medicines for children, including painkillers (paracetamol and ibuprofen), antibiotics (amoxicillin and erythromycin) and throat syrups (linctus).

They found that 40 percent of these medicines contained at least one of the seven food additives linked to hyperactivity in children. These seven additives are currently under review by the Food Standards Agency (FSA) following a study on their effect on children's behaviour

Also, the additives were found in 20 percent of the medicines aimed at children under the age of three, even though they have already been banned from food and drink for children of this age

You want to hear what a 'spokesperson' for the MHRA said?

"It's important to remember that the quantities of additives used in medicines are not as high as those used in foods. Also, children don't consume medicines they way they consume food - they should only be taking the necessary dose for a short period of time. Preservatives and other additives play a vital role in medicines - many couldn't be produced, stored or administered without them."

He continued, "Parents and carers should read the patient information leaflets that accompany their child's medicine. This will contain details of the additives included and any known side-effects. If they are still concerned, they should talk to their pharmacist or GP."

Fiddy Rant:

The Food Commission looked at 70 prescription and over-the-counter medicines for children you incompetent fools!

Read the patient information leaflets? Would this be the same patient information leaflets that came accompanied with packets of Seroxat stating you could not get addicted?

When are you going to listen to the patients and patient support groups?

Oh, nice touch at the end of the statement: ...'If they are still concerned, they should talk to their pharmacist or GP.'

Thus leaving the MHRA in the clear eh?

Yet another failure in this so-called regulatory system.

Additives cause hyperactivity - fact

How do GP's treat hyperactivity?

Drugs, made by the very same people who fund the MHRA

Who needs Pharmaceutical Drug Reps when you have an agency doing their jobs for them?

Shocking, truly shocking!


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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Hmmmm - Here's one for you Kent

39. 28 February 13:37 Associated Newspapers Ltd, London, London, City of, United Kingdom

Watching ME Watching YOU Prof. Kent Woods


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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Dear MHRA... Now We Have Your Attention...

... what do you intend to do about this whole Seroxat debacle?

1. Are you going to admit to the British public that you were wrong?

2. Are you going to take responsibilty and admit that there have been failings by the MHRA on a calamitous scale?

3. Are you going to publically apologise for these failings?

4. Are you going to remove your Chairman, Alisdair Breckenridge, from his seat for publically stating in the New Statesman in 2005... and I quote: “If you go back - and I read this out to the Health Select Committee - to the data sheet on Seroxat when it was licensed in 1991, we spelt out word for word the problems of withdrawal from Seroxat, in words that we could not improve now. 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”.

5. Is the CEO, Kent Woods, of the MHRA now going to do the honourable thing and resign from his position?

Face it, you have not changed at all. You may have changed your name from the Medicines Control Agency (MCA) to Medicines and Healthcare products Regulatory Agency (MHRA) but lessons HAVE NOT been learned have they?

Nearly a third of the 181 experts who sat on the Medicines Control Agency (MCA) committees were linked to GlaxoSmithKline, Aventis Pasteur or Merck, Sharpe and Dohme.

Need I remind you what the MMR jab did to children?

You failed, and to coin the phrase of Charles Medawar of Social Audit, you failed miserably.

You have done it once again.

You HAVE NOT listened to your patients.

Janice Simmons runs the Seroxat & SSri User Group. Since its launch she has recieved over 15,000 emails - only 4 of which defended Seroxat!

And you say the benefits outweigh the risks?

It's high time you took a good look at yourselves. Look in the mirror. It's not a pretty sight is it? Failure never is.

The MCA is no more. We now have the MHRA. It's pretty much like Builders From Hell (ITV). A plumber, working for Smith & Co of Timbuktoo, does an unsatisfactory job - he is rumbled by hidden cameras. Smith & Co of Timbuktoo close down. Some months later they reopen, changing their name - they still trade, still carry out unsatisfactory work. That pretty much sums up the MHRA.

Valuable lessons have not be learned. The Myodil scandal, the MMR/Autism scandal and now the Seroxat scandal.

Heads should roll for this. Starting at the top, the CEO of the MHRA, Kent Woods. Others should follow - Breckenridge & Hudson et al.

The truth will out. It may take a long time but it will always out.


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

By Bob Fiddaman

ISBN: 978-1-84991-120-7




Dobbin, Jim

That this House welcomes the Department of Health's announcement to increase the provision of talking therapy for depression; notes Professor Irving Kirsch's study of the manufacturer's trials of the SSRI anti-depressants Prozac, Seroxat and Efexor and his conclusion that these drugs are not effective; notes that there is zero cost-effectiveness to drugs that do not work; further notes that large numbers of people are involuntary addicted to these drugs and suffer bizarre and severe side effects which leave them unable to work; calls upon the National Institute of Health and Clinical Excellence to review the approval of these drugs; calls upon the Government to provide withdrawal clinics for people addicted to prescribed drugs; further calls upon the Government to provide appropriate rehabilitation to bring these people back into the workforce; urges the Government to organise controlled withdrawal of these drugs from the market; and further urges the Government to investigate how the manufacturers and distributors obtained product licences and to implement the recommendations of the Fourth Report of the Health Committee, Session 2004-05, on the Influence of the Pharmaceutical Industry, HC42-1, including an independent review of the UK drug licensing authority the Medicines and Healthcare Products Regulatory Agency.


Finally, the penny has dropped!

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Wednesday, February 27, 2008

It truly is 'Quite An Experience!

Fellow campaigner, Matt Holford's blog, 'It's Quite An Experience' is a must read. If only to see the incompetence of the UK Medicine's regulator and their reluctance to answer basic fundemental questions to a patient. I've had to endure 'made up rules' but Matt is basically being totally ignored and his requests for answers being labelled as vexatious by Kent Woods and his band of merrymen.

I love this rant from Matt that he entitled 'Here's an interesting little snippet'. Not one to hide behind his rants, Matt sent the article to the following: To the Ministry of Truth, at the MHRA, copied to Brown, Johnson and Vara, blind copied to lots of people:

Here is the article in it's glorious entirety:

Here's an interesting little snippet:

To the Ministry of Truth, at the MHRA, copied to Brown, Johnson and Vara, blind copied to lots of people:

Drug giants warned: Tell the truth on medicines

Towards the bottom of the piece, the D'oh is quoted as saying:

"The Government has consistently supported open access to information about research when the findings could affect decisions about treatment or health outcomes. We planned to support the principle of mandatory registration of clinical trials in the UK, but legal advice stated this would be illegal under EU law."

First, I don't think anybody should be positioned, such that they can make a decision upon whether findings "affect decisions about treatment..." The information should be made publicly available. End of. Second, it was my understanding, although the MHRA never explicitly confirmed that it was also its understanding, that the Medicines for Human Use (Clinical Trials) Regulations ("MHU") required that all trials be registered, and that regulators be notified when trials had ended (it didn't have to confirm it: it's Law). The MHU is itself an implementation of EU Law. So, the EU says that all trials must be registered and notified when they end, but there is no requirement to do other than submit the data to the regulator - the Worshipful Company is protected by EU Law from wider scrutiny?

The loophole (or should that be "black hole"?), here is the regulator. It has the power to demand data. It receives all data, we're told. And then it makes really fucking weird choices that other bodies making similar decisions (eg NICE), are altogether more circumspect about, given that they don't have access to the same data.

And all this, which as we know leads to abuse of trust (Vioxx, Avandia, Seroxat, Seroquel, etc, etc, ad nauseum), is permitted to continue, because the Worshipful Company is entitled to pretend that trials results are trade secrets. I think somebody's putting the wrong weighting on their decision-making. This is about public health and safety, not commerce, and if one approaches this problem from the former angle, this whole cluster fuck looks anomalous. It only looks proper and normal, when a minority interest is being protected.


You can read more of Matt's correspondence with the MHRA at:

It really is quite an experience.


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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



GSK hits back over 'alarmist' antidepressant analysis

Well you didn't expect them to actually admit it now did you?

They have a history of admitting no liability so why change?

The statement can be read at Pharma Times.

Keeping with GSK tradition I'd like to summarise it for you - as they do with their clinical trial results. Hope you don't mind Glaxo - I mean, what's good for the goose eh?

GSK “believe that it has caused unnecessary alarm and concern for patients”.
Hmmm. Great let's put the onus on the patients. Let's spin this on its head to show the patients that we really care about their fears. Have GSK EVER listened to their patients?

...antidepressants “remain an important option, in addition to counselling and lifestyle changes, for patients suffering from depression”.
But GSK know that counselling costs money, money that this government are not prepared to offer up. Sure, promises were made yesterday as UK Health Secretary Alan Johnson unveiled plans for a major new programme to train an extra 3,600 psychological therapists. But actions speak louder than words.

“we strongly believe that the authors’ interpretation is incorrect and is clearly at odds with the benefits of antidepressants routinely observed in actual clinical practice”.
This is a little gem isn't it? You notice how they use the term 'antidepressants' and NOT 'Seroxat'? Tell me, What are the benefits of Seroxat? I bet you I can give you at least 10 risks to one benefit! Here's nearly 10,000 people that disagree with you.

“regulatory bodies around the world have conducted extensive reviews of published and unpublished data for licensed antidepressants and have concluded that these medicines provide benefit to patients”.
There's that word again, 'benefit' - and why the omission once more of the word 'Seroxat'? The truth is GSK, you are being investigated for not submitting published and unpublished data to the very same people you claim have conducted extensive reviews. Extensive reviews of the data you provided them maybe - but we all know the data you DO NOT give them clearly shows that your drug (in this case, Seroxat) is defective. And while we are on the subject, the Medicines Regulator here in the UK have been less than satisfactory when reviewing data. One only has to look at the MMR/Autism debacle (SEE PART E HERE)- They messed up then and they have clearly messed up again regarding Seroxat... and will continue to do so as long as there is a conflict of interest, ie; Alisdair Breckenridge & Ian Hudson - you remember them don't you Glaxo? Sure you do - they now work for the MHRA - Can you ever remember them working for you?

GSK says that “contrary to what has been reported”, the study has only examined a small subset of the total data available for antidepressants. With paroxetine for example, “this study only considers data from 16 trials out of a total database of more than 170 trials involving at least 14,000 patients”.
And did you offer all your data to the medicines regulator regarding Paxil Study 329? C'mon, we really can see right through you Glaxo.

With regards to Paxil, “all trial data published and unpublished were submitted to regulators, at the time of registration”, GSK notes, saying that all the data related to paroxetine, “regardless of study outcome”, are available at the company’s clinical trials register on its website.
Well, we know that's a lie. Glenmullen's report shows that it is as does Breggin's report from 2001. Tell me Glaxo, why are the MHRA currently investigating you?

“rejects any suggestion that we deliberately withheld data on paroxetine”

In addition, however, GSK responded to a request for data on the use of paroxetine in children. The spokesperson noted that the company provided a list of the studies that had either been completed or were underway, “however this was an unlicensed indication and was subject to an ongoing regulatory review by the Medicines and Healthcare products Regulatory Agency. It was therefore not appropriate to provide these data to NICE ahead of the MHRA's conclusions."
So now a criminal investigation becomes a 'review'? As far as I am aware, the MHRA are investigating you! This is no review. If it is merely a review, it will probably be laden with errors.

Alison Cobb, treatments expert at mental health group Mind, said that the study “makes a serious challenge to the predominance of drugs in treating depression"

At last! someone with compassion!

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



The Three Little Pigs

The Three Little Pigs

Once upon a time there were three little pigs, Kent, Dawn and Justice, and the time came for them to leave home and seek their fortunes.

Before they left, their mother told them “Whatever you do , do it the best that you can because that's the way to get along in the world.”

The first little pig, Kent, who was CEO of the UK Medicines Regulator, the MHRA, built his house out of straw because it was the easiest thing to do.

The second little pig, Dawn, who was the Minister of Health in the UK, built her house out of sticks. This was a little bit stronger than a straw house.

The third little pig, Justice, who represented Seroxat patients globally, built his house out of bricks.

One night the big bad wolf, otherwise known as GlaxoSmithKline or GSK, and who dearly loved to eat fat little piggies, came along and saw the first little pig in his house of straw. He said “Let me in, Let me in, little pig or I'll huff and I'll puff and I'll blow your house in!”

“Not by the hair of my chinny chin chin”, said Kent the little pig.

But of course the wolf did blow the house in and ate the first little pig.

The house was destroyed and the MHRA infiltrated by the big bad wolf (GlaxoSmithKline)

The wolf then came to the house of sticks.

“Let me in ,Let me in little pig or I'll huff and I'll puff and I'll blow your house in”

“Not by the hair of my chinny chin chin”, said Dawn the little pig.

But the wolf blew that house in too, and ate the second little pig.

The house was destroyed and the Minister of Health became embroiled by the big bad wolf (GlaxoSmithKline)

The wolf then came to the house of bricks.

“Let me in , let me in” cried the wolf

“Or I'll huff and I'll puff till I blow your house in”.

“Not by the hair of my chinny chin chin” said Justice the pig.

Well, the wolf huffed and puffed but he could not blow down that brick house.

But the wolf was a sly old wolf and he climbed up on the roof to look for a way into the brick house.

The little pig Justice saw the wolf climb up on the roof and lit a roaring fire in the fireplace and placed on it a large kettle of water.

When the wolf finally found the hole in the chimney he crawled down and KERSPLASH right into that kettle of water and that was the end of the troubles for Justice with the big bad wolf.

The next day the little pig Justice invited his mother over . She said “You see Justice, it is just as I told you. The way to get along in the world is to do things as well as you can.”

The third little pig Justice, represented by Seroxat patients globally lived happily ever after.

The two pigs Kent and Dawn, whose houses were destroyed, both went away into the woods to lick their wounds.

The moral of this story?

Never mess with people whose lives you have fucked!

The irony of this story?

For years Seroxat sufferers have met with brick walls when asking questions to Pigs 1 & 2

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Tuesday, February 26, 2008

Any comment from the MHRA or DoH?

Hate to say it... but WE told you so.

Anyone care to comment? Benbow? Breckenridge? Woods? The Doh? Gisela Stuart MP? The MHRA?


Prozac pills 'do not work' - THE SUN
ANTI-depressant pills such as Prozac do not work on most patients, medics claimed yesterday. A major study by the University of Hull analysed the four main antidepressants — Prozac (also known as Fluoxetine), Venlafaxine, Nefazodone and Paroxetine...

Taking some types of antidepressant may be a waste of time, say researchers. Researchers used Freedom of Information laws to analysis American data on modern anti-depressants such as Prozac, Effexor and Seroxat...

Papers say 'the drugs don't work' - BBC News
The message across many front pages is clear - 'the drugs don't work'...

Hardly anyone helped by anti-depressants: study - The Ottawa Citizen
Researchers who pooled data from all clinical trials -- published or not -- submitted to American drug regulators for four "new-generation" anti-depressants that include Prozac and Paxil found the drugs provided virtually no benefit over placebos for moderate depression, and only a small difference for the severely depressed.

Antidepressant drugs not effective for most patients -- official study - CNN Money
Prozac and other antidepressant drugs in the same class do not work according to a major review released today, reports The Guardian...

Depression drugs don’t work, finds data review - The Times Online
Millions of people taking commonly prescribed antidepressants such as Prozac and Seroxat might as well be taking a placebo, according to the first study to include unpublished evidence.

Anti-depressants 'not much of a help' - The Cheers
For the depressed, this might come as a big blow- according to a new study the 'happy pills' or anti-depressants they take, have little or no impact. In the study, the research team focused on drugs in the class known as Selective Serotonin Reuptake Inhibitors (SSRIs), which work by increasing levels of the mood controlling chemical serotonin in the brain. These included fluoxetine (Prozac), venlafaxine (Efexor) and paroxetine (Seroxat).

Prozac is no better than a placebo, shows 'fantastically important' study - Daily Mail
The drugs studied - including Prozac, Seroxat and Efexor - were little more effective than placebos in improving the mental health in the majority of cases, ...

Talking Back To Prozac - CBS News
The pattern they saw from the trial results of fluoxetine (Prozac), paroxetine (Seroxat), venlafaxine (Effexor) and nefazodone (Serzone) was consistent. "Using complete data sets (including unpublished data) and a substantially larger data set of this type than has been previously reported, we find the overall effect of new-generation antidepressant medication is below recommended criteria for clinical significance,"

Dummy Pills Can Aid Depression As Much As Prozac, Claims Study - The Daily Record
Researchers found little difference in mildly depressed patients who took the antidepressants Prozac, Effexor, Serzone and Seroxat/Paxil and those who took a dummy pill, or placebo.

Millions taking Prozac 'may as well be taking a placebo' - study - Irish Independent
MILLIONS of people taking commonly prescribed anti-depressants such as Prozac and Seroxat might as well be taking a dummy pill, a study suggests today.

Prozac, used by 40m people, does not work say scientists - The Guardian
A spokesman for GlaxoSmithKline, which makes Seroxat, said the authors had failed to acknowledge the "very positive" benefits of the treatment and their conclusions were "at odds with what has been seen in actual clinical practice". (snigger)

New study implies anti-depressants ineffective - RTE News
Researchers reviewed a series of studies, both published and unpublished, on four anti-depressants, examining the question of whether a person's response to these drugs hinged on how depressed they were before getting treatment. The drugs are all so-called selective serotonin reuptake inhibitors, or SSRIs.

GPs urged to cut number of antidepressant prescriptions - Management in Practice
A charity is calling for GPs to reduce the number of antidepressant prescriptions after a new study found some of the latest brands have limited benefits. These included studies on Prozac, Efexor, and Seroxat

Study casts doubt over anti-depressants - ABC Online Australia
A major new study has cast doubt on whether anti-depressant drugs taken by millions around the world do any good at all. The research was published in the online journal, Public Library of Science Medicine. Critics of the pharmaceutical industry predict shock waves for what's become a global billion dollar business.

Why antidepressants don't work - Marie Claire
The researchers claim prescription drugs help only a small number of severely depressed individuals, although the makers of Prozac and Seroxat, unsurprisingly, are disputing the claims.

Psych Drug Shocker: Antidepressant Drugs Work No Better than Placebo; Big Pharma Hoax Finally Exposed - The Westender Brisbane Australia
The researchers obtained data on all the clinical trials submitted to the FDA for the licensing of fluoxetine, venlafaxine, nefazodone, and paroxetine. They then used meta-analytic techniques to investigate whether the initial severity of depression affected the HRSD improvement scores for the drug and placebo groups in these trials.

Antidepressants 'not working' - Channel 4 (UK)
Research suggests new-generation antidepressants are often no more effective than dummy pills. They included antidepressants regularly prescribed in the UK, including fluoxetine (Prozac), venlafaxine (Efexor) and paroxetine (Seroxat).

A new study suggests that anti-depressants such as Prozac, prescribed to millions of people all over the world, could be largely ineffective. - Radio New Zealand
Marjorie Wallace, head of the British mental health charity Sane, said that if these results were confirmed they could be "very disturbing". But the makers of Prozac and Seroxat, two of the commonest anti-depressants, said they disagreed with the findings. (Hmmm)

Antidepressants 'not working' - ITN UK
They said even trials suggesting benefit for severely depressed people did not provide evidence of clear clinical benefit. They included antidepressants regularly prescribed in the UK, including fluoxetine (Prozac), venlafaxine (Efexor) and paroxetine (Seroxat).

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Study says antidepressants are ineffective

Monday, February 25, 2008

They are taken by millions of people – but antidepressants such as Prozac and Seroxat are largely a waste of time, research suggests today.

They work no better than a dummy pill for mildly depressed patients and for most people suffering severe depression, a review of clinical trials found.

Even trials suggesting they helped severely depressed people did not provide evidence of clear clinical benefit, researchers said.


Begs the question why the UK needs a medicine regulator - they clearly ARE NOT doing their job!

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Monday, February 25, 2008

Glaxo - MCA - The forgotten bad press

Thought I'd remind those 'outsiders' visiting this blog of who it is I've actually got a gripe with here... it is my beleif that they lied to me and millions of others about the safety and efficacy of Seroxat in BOTH adults AND children. Here are some more of their drugs where I believe they has been less than honest

Lymerix had caused controversy in recent years, as patients said they were sickened by the vaccine and asked the government to restrict sales. Some filed lawsuits against maker GlaxoSmithKline...

A mass immunisation campaign with a Urabe-containing MMR vaccine was carried out in 1997 in the city of Salvador, NE Brazil, with a target population of children aged 1-11 years.
There was an outbreak of aseptic meningitis following the mass campaign. The MMR vaccine used in Salvador was the Pluserix vaccine supplied by SmithKline Beecham Pharmaceuticals, London, UK...

"You've seen the chemical make-up of the substance - it contains benzene, hydrochloric acid and sulphuric acid," he said. "How could they ever think that injecting those chemicals into somebody's back would not be harmful?" Doctors were warned not to spill the chemical on rubber because it destroys it and dissolves polystyrene cups...

Glaxo executives were steaming in early 1999 over the work ofbiostatistician Michael Elsahoff and other FDA reviewers who had examinedthe company's new flu drug, Relenza. The reviewers found that Relenza was no more effective than a placeboin treating common flu symptoms among American patients...

When the antibiotic Raxar was approved on Nov. 6, 1997, FDA officials knew that it too might cause irregular rhythm and stop a patient's heart. An agency medical officer, Dr. Andrea N. Meyerhoff, suspected that two of four patients who died after taking Raxar in clinical trials possibly suffered heart-rhythm disturbances caused by the drug. Meyerhoff noted in her review that the drug manufacturer, Glaxo Wellcome Inc., said Raxar played no role in the deaths. But Meyerhoff wrote that the two cases posed an open question...

Agency officials agreed in July 1999 to conduct a fast-track medicalreview of Lotronex, a pill from Glaxo Wellcome Inc. intended to treatirritable bowel syndrome in women. Senior found other troubling results. He warned that 27% of thepatients who took Lotronex in Glaxo's studies experienced constipation. Henoted that not a single patient who took a placebo pill developed ischemiccolitis and that only 5% of the placebo patients got constipated...

A CORONER has raised fresh concerns over the safety of anti-smoking drug Zyban after a man died within days of taking it. A spokeswoman for GlaxoSmithKline which produces Zyban, said it should be avoided by patients with head injuries, heart, liver or kidney conditions or those with brain tumours. She added: "Zyban is contra-indicated in patients with a prior or current seizure disorder such as epilepsy"...

GSK at centre of Russian vaccine scandal
The pharmaceutical giant GlaxoSmithKline has become embroiled in a vaccine-testing scandal in southern Russia after prosecutors set out criminal charges against three doctors involved in a trial of the company's drugs...

UK babies given toxic vaccines, admits Glaxo
British drug giant GlaxoSmithKline has finally admitted that thousands of babies in this country were inoculated with a batch of toxic whooping cough vaccines in the 1970s. Some experts believe that these Trivax vaccines - which had not passed critical company safety tests - may have caused permanent brain damage and even fatalities in young children...

Senate Report Alleges GSK Intimidation Over Avandia Concerns
Two high-ranking senators placed a report in the Congressional Record detailing how GlaxoSmithKline (GSK) employees allegedly intimidated a scientist who raised concerns over the company’s Type 2 diabetes drug Avandia...

Orphans used for HIV trials
GlaxoSmithKline embroiled in scandal in which babies and children were allegedly used as `laboratory animals'...

Have to throw the MHRA in here to.

They've always denied a conflict of interest... but were caught out some years back when they were known as the Medicines Control Agency - Or MCA

Many Government advisers on the safety of medicines have close financial ties with the pharmaceutical giants who produce the controversial measles, mumps and rubella jab. A Sunday Express investigation has found that nearly a third of the 181 experts who sit on the Medicines Control Agency (MCA) committees are linked to GlaxoSmithKline, Aventis Pasteur or Merck, Sharpe and Dohme.

It was not long after that the MCA were 'revamped' and changed its name to the MHRA.

Lets see some more MCA cock-ups shall we?

Medicines Division was admitted by its then management to have been in chaos in 1988, year that MMR was licensed in UK (for details, see Draft Factual Account 17 of Evidence to BSE Inquiry, pp 31-33).

Had no effective method of finding files, and severe staff shortages in key areas

Product licence renewals were handled purely administratively without scientific input. MMR wasn’t a renewal, but may have been treated as little more than one, as singles already licensed, and long-term complications not foreseen. Therefore highly likely that MMR went through "on the nod"

Follow-up of trial children was only three weeks (chicken & egg situation, with autism being missed, MMR then being declared safe, then safety record used to repudiate autism connection - a circular argument)

DoH uses circular argument, "MMR has good safety record", therefore no problem. But slow degeneration into autism not recognised as consequence, and no figures being kept by MCA on this. Therefore autism numbers not added in, and safety record remains "good".

The Medicines Control Agency’ adverse reaction warning system, known as the Yellow Card system, by their own admission only picks up 10-15% of even serious adverse reactions (source: Guidance on Interpretation of Yellow Card Data, MCA, 1997). System woefully weak.

Yellow Card unable to identify problem because it must be shown that adverse event occurs more frequently in vaccinated than unvaccinated population - very difficult to do when almost all children vaccinated. (source: letter of MCA of 21/8/98 to David Thrower)

Yellow Card depends on doctors, dentists, coroners and hospital pharmacists to file reports (source: MCA). But these are unlikely to be able to make the link between autism and MMR.

Adverse reaction reports are added to the ADROIT database, introduced in 1991. However, the database can only deal with the data it actually receives. If a syndrome is missed completely, then there will be no data in the database.

Yellow Card is voluntary for health professionals, but compulsory for pharmaceuticals manufacturers. But this depends on adverse reactions being reported to manufacturers - again, unlikely.

Parents must also be able to make link between MMR/autism. This was not possible pre-1998, as publicity had never been given to connection between vaccination and later degeneration into autism

In any case, "it has been estimated.....that only 10-15% of serious ADRs (adverse drug reactions) are reported" (1997 Guidance Sheet issued by MCA), and " is accepted that spontaneous reporting schemes have limitations" (source: MCA letter of 29/3/99 to David Thrower). And worse still, "Autism has been very rarely reported as an adverse drug reaction.....These figures are unsurprising since autism is not a recognised ADR to any particular medicinal substance" (Source: letter of MCA of 29/3/99 to David Thrower). The chicken-and-egg argument again.

And a potentially-significant admission, "Evidence from the Yellow Card scheme is unlikely to resolve the issue as to whether or not autism could be causally associated with MMR vaccine" (Source: letter of MCA of 29/3/99 to David Thrower)

MCA’s estimate of only 10-15% of ADRs being reported may even itself be optimistic - West Midlands Centre for Adverse Drug Reactions Reporting did survey and found rate of only 6.3% of all ADRs reported.

All recent improvements to Yellow Card have been irrelevant to autism detection (extension of system to hospital pharmacists, GP prescribing systems, community pharmacists, nurses)

Similar situation in USA - "On the basis of Vaccine Adverse Event Reporting System alone, we don’t have proof that vaccines are not contributing to (vaccine-related problems)(source: Caveats to Interpretation of VAERS Data, Centre for Biologics Evaluation & Research, VAERS, 1998)

Whole monitoring system is therefore passive, and irrelevant to autism - like smoke-alarm with no battery.


Call them what you will; Glaxo Wellcome, SmithKline Beecham, GlaxoSmithKline. The MCA or The MHRA - After reading these catalogue of failures - DO YOU TRUST THEM?

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Dr. Verstraeten - GlaxoSmithKline


Source: Moms Against Mercury

WASHINGTON, DC - A new vaccine study by the Centers for Disease Control (CDC) containing manipulated scientific data is published in the November issue of Pediatrics. The study suggests no link between neurological disorders such as autism and mercury in childhood vaccines, despite an earlier unpublished study by the CDC, which found a significant link between the two.

Documents obtained through the Freedom of Information Act (FOIA) by Safe Minds, a research organization dedicated to identifying causes of autism in children, expose concern on the part of the study's author, Dr. Thomas Verstraeten, that his findings indicated a link between Thimerosal (mercury) in vaccines and the alarming rate of autism in children exposed to the toxic substance.

Once Dr. Verstraeten began working for vaccine manufacturer GlaxoSmithKline (GSK), he altered the data, sampling and methodology of the study so that results would point to enough inconsistencies to cast doubt that mercury in vaccines causes autism.

Dr. Verstraeten is not named as an employee of GSK in the study, but rather is misidentified as an employee of the Centers for Disease Control. GSK is one of only five vaccine manufacturers in the world and produces mercury-laced vaccines.

Data was manipulated, in part, by adding in samples from Harvard Pilgrim, an HMO in Massachusetts, the only state in the country that severely underreported autism in the years looked at in the study, appearing to have almost no cases compared to a nearly 500% increase in other states. Using Harvard Pilgrim helped skew results so that a conclusion of "inconsistencies" between Harvard Pilgrim and other HMO's appears to disprove a link between mercury-laced vaccines and autism.

Harvard Pilgrim filed for bankruptcy in 1999 and was taken over by the state in 2000. One of their biggest problems was record keeping. Harvard Pilgrim, according to The Journal of Law, Medicine and Ethics (Sept. 2000) used computers that had "little compatibility to communicate effectively with one another" and "incapable of consolidating the data accurately."

On July 14, 2000, and prior to his employment at GlaxoSmithKline, Dr. Verstraeten wrote in an e-mail to a colleague " I at least feel we should use sound scientific argumentation and not let our standards be dictated by our desire to disprove and unpleasant theory"

From FOIA-obtained documents from "secret" meeting in June 2000 on unreleased findings.

Dr. Verstraeten: " When I saw this, and I went back through the literature, I was actually stunned by what I saw because I thought it [autism link] is plausible."

Colleague: "The number of dose related relationships are statistically significant. You can play with this all you want. They are statistically significant."

Colleague: "I do not want [my] grandson to get a Thimerosal containing vaccine until we know better what is going on."

Colleague: "perhaps this study should not have been done at all, because the outcome of it could have, to some extent, been predicted, and we have all reached this point now where we are left hanging. I know how we handle it from here is extremely problematic."

Sounds familiar huh?

THE ACTUAL STUDY: Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases

Analysis and Critique of the CDC's Handling of the Thimerosal Exposure Assessment Based on Vaccine Safety Datalink (VSD) Information

From Wikipedia:

Criticism of report delays

By the time Verstraeten published the amended study results in 2003, he had gone to work for GlaxoSmithKline.[5] Critics contend that the delay in publication was to afford Verstraeten sufficient time fix the data around what they allege to be the CDC's objective of obscuring the link between thimerosal and autism.[6] Dr. Verstraeten denies the allegations, and has published a substantial account of the matter in the journal Pediatrics.[7] In September 2007, a report of the US Senate's committee on health, education, labor and pensions rejected allegations of impropriety [8].

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Dept of Health, MP & Alisdair Breckenridge

----- Original Message -----
From: fiddaman
To: STUART, Gisela
Sent: Monday, February 25, 2008 6:49 AM
Subject: Dept of Health & Alisdair Breckenridge MHRA

Dear Gisela Stuart MP,

Still nothing regarding request you sent Dept of Health over a month ago. Be grateful if you could pick up the phone and ask Dawn Primarolo directly what the benefit of Seroxat is then relay answer to me.

The Dept of Health WILL NOT find the answer on my blog so they have no need to visit it (which they have been doing this past month)

I'd also like you to write to the MHRA for me because they are now refusing to answer any of my queries on the grounds that (and here I quote) "We see no point in answering questions where you have prejudged the veracity of any answers".

This does not fall under any protocol or MHRA ruling or amendment so therefore I would like you to write them and ask them the following:

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?

I would also be grateful if you could send me a copy of this request.

You can email the MHRA Information Centre here:


Bob Fiddaman

cc The Guardian

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Sunday, February 24, 2008

MHRA - Jobs for 'the boys?'

Watson Names Gordon Munro, Ph.D., Senior Vice President, Quality Assurance

Mar 15, 2004

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today the appointment of Gordon Munro, Ph.D., 57, to Senior Vice President, Quality Assurance. Dr. Munro replaces Donald Britt, who will be retiring later this year.

"We are extremely delighted to welcome Gordon to the Watson organization and to our senior management team," began Allen Chao, Ph.D., Chairman and Chief Executive Officer. "Gordon will bring great industry depth and perspective to our quality organization. Based on his extensive experience in both the industry and the regulatory arena, we believe his leadership can add tremendously to our quality operations," he said

Dr. Munro brings to Watson a unique blend of industry and regulatory experience. His notable contributions in the industry led to an officer appointment with the UK Medicines Control Agency (MCA). During the past seven years, he has held the position of Director, Inspection and Enforcement Division of the United Kingdom Medicines Control Agency, responsible for all inspections related to Good Manufacturing Practices, Good Distribution Practices, Good Laboratory Practices, and Good Clinical Practices;

Most recently, he was Director of Inspection and Enforcement, and Acting Head of Medicines at the Medicines and Healthcare products Regulatory Agency (MHRA)

Prior to the MHRA, Dr. Munro was with GlaxoSmithKline for over 25 years

Unusual - I actually thought ex GSK employees finished their careers at the MHRA!


Jobs for the boys?

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



SmithKline Beecham Fined - A history

Smithkline Beecham fined for safety breach
Ireland Online - Nov 19, 2003
A company that won a 2003 Ministerial merit award for health and safety was convicted and fined today on four charges related to a release of toxic and ...

Drug Firm to Pay $325 Million for Overbilling
SmithKline Beecham, the giant British drug company, has agreed to pay the United States $325 million to settle charges that it had overcharged Medicare for patient services, the authorities said today...

SmithKline Beecham $102,000
A judge ruled yesterday that former Palo Alto medical technician Elaine M. Giorgi should stand trial on six felony counts for endangering patients by allegedly reusing syringes while drawing blood. State health officials eventually barred her from working in the medical field, fined SmithKline Beecham $102,000 and urged thousands of worried patients to be tested for HIV, hepatitis B and hepatitis C...

Four injured in Glaxo factory blast
Four people are being treated in hospital following an explosion at a GlaxoSmithKline factory in Strathclyde, police have confirmed. SmithKline Beecham were fined £10,000 at Kilmarnock Sheriff Court in September that year after they admitted operating a dryer with a faulty oxygen gauge.

Many more HERE

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Saturday, February 23, 2008

Dirty Tactics of SmithKline?

The following is a complaint made by Te Turanga O Te Mate Kowhai - D Winterbourn and subsequesnt descision regarding SmithKline Beecham (NZ) Ltd Advertisement of Hepatitis Vaccine - Twinrix.

It is truly shocking to witness just how low these people will stoop just to make money.

The file (in RTF) can be downloaded HERE

Here is a brief summary

Meeting 17 July 2000

Complainant: Te Turanga O Te Mate Kowhai - D Winterbourn
Advertisement: SmithKline Beecham (NZ) Ltd - Twinrix

Complaint: An advertisement for SmithKline Beecham promoting its "Twinrix Vaccine" (the trademark name for a combined hepatitis A and B vaccine) was published in the Pacificwave magazine. The advertisement stated among other things that, "…Hepatitis B is the most infectious of the blood borne viruses and is estimated to be 100 times more infectious than HIV. Its spread through blood, saliva and sexual fluids. Sharing a toothbrush or razor, a game of rugby or something as beautiful as a passionate kiss could lead to infection.

The Complainant said: "As Director of The Hepatitis Foundation, I wish to make a formal complaint about print advertisement promoting Twinrix, which appeared in Pacific Wave March 2000.

Twinrix is a trademark name for a combined hepatitis A and B vaccine, supplied to the New Zealand market by SmithKline Beecham (NZ) Ltd.The basis of the Foundation’s complaint is that the advertisement disregards the ASA’s Codes of Practice, and Advertising Code of Ethics. In particular, point 4 of the Basic Principles, "that all advertisements should be prepared with a due sense of social responsibility to consumers and to society".

Our main argument is that some of the information contained in the advert is medically unproven. The advertisement copy reads:“Hepatitis B is the most infectious of the blood borne viruses and is estimated to be 100 times more infectious than HIV. Its spread through blood, saliva and sexual fluids. Sharing a toothbrush or razor, a game of rugby or something as beautiful as a passionate kiss could lead to infection”.There is no medically proven documentation to prove that hepatitis B can be transmitted from one person to another in this manner. It is true that the virus can be detected in saliva, but cross infection through ‘wet’ kissing, especially among adults, is unproven. I believe this type of advertising plays unnecessarily on peoples’ fears and instills information, which is quite simply, untrue and without clinical proof. Perhaps Twinrix’s manufacturers are promoting this vaccine, on the wave of interest caused by the Foundation’s current government-funded hepatitis B screening programme.

Consumers look to these organisations as bastions of ethical self-regulation in terms of
information supplied for the public good.

I believe, Twinrix’s suppliers have overstepped the codes of common good and decency.

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



GSK To Be Investigated (Again!)

Source: Reuters

French judges probe firms over vaccinations

PARIS, Jan 31 (Reuters) - French authorities have opened a formal investigation into two managers from drugs groups GlaxoSmithKline (GSK.L: Quote, Profile, Research) and Sanofi Pasteur over a vaccination campaign in the 1990s, a judicial source said late on Thursday.

Judge Marie-Odile Bertella-Geffroy also opened an investigation for manslaughter against Sanofi Pasteur MSD, a joint venture between Sanofi Aventis (SASY.PA: Quote, Profile, Research) and Merck (MRK.N: Quote, Profile, Research), the same source said.

The investigations follow allegations that the companies failed to fully disclose side effects from an anti-hepatitis B drug used in a vaccination campaign between 1994 and 1998.

There was no immediate comment from the companies or the two managers involved.

From 1994 to 1998, almost two thirds of the French population and almost all newborn babies were vaccinated against hepatitis B, but the campaign was suspended after concerns arose about possible secondary effects from the treatments.

Some 30 plaintiffs have launched a civil action in the case, including the families of five people who died after vaccination.

(Reporting by Thierry Leveque; Writing by James Mackenzie; Editing by David Holmes)


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

By Bob Fiddaman

ISBN: 978-1-84991-120-7



Friday, February 22, 2008


Source: Theraputics Daily

A spokeswoman for Sen. Charles Grassley (R-IA) says documents submitted by GlaxoSmithKline on its drug Paxil have, at first glance, not alleviated the lawmaker's suspicions that GSK knew about increased suicide risks associated with the antidepressant years before it sent a 2006 warning letter to physicians.

"Our concerns have not changed," says spokeswoman Jill Kozeny.

The lawmaker received a tall stack of papers from GSK the day after his deadline for the company to submit documents on Paxil. Kozeny says Grassley's staff is going through the documents this week and declined to comment on the next steps Grassley might take.

A magazine article had sparked his interest in trying to pinpoint when GSK knew about elevated risks that were not detected during the premarket review of the drug (see FDA Week, Feb. 8). GSK says the researcher who claims the company knew of the higher suicide risks at an earlier date has incorrectly analyzed the data.

Grassley also launched an investigation recently into Merck's cholesterol drug Vytorin. House Energy and Commerce Committee leaders are conducting a similar investigation.

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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