Monsanto Roundup Lawsuit

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Author of The evidence, however, is clear, the Seroxat scandal
Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Saturday, March 31, 2007

Liebenagate - The excuse!

I've heard some lame ass excuses in my time but GSK's latest really takes the biscuit!

Someone remind me.... It's April the 1st tomorrow isn't it?


Drink deficient only in Australasia, says GSK

The makers of Ribena have told UK customers the problems with the product in Australia and New Zealand came from leaving the bottles and cartons on shop shelves too long - a claim rubbished by food scientists.

GlaxoSmithKline, which had a worldwide turnover of $61 billion in 2005, was fined $217,000 this week after pleading guilty to 15 breaches of the Fair Trading Act.

Through its lawyer, Adam Ross, the company accepted Commerce Commission allegations that claims ready-to-drink Ribena contained 7mg of vitamin C per 100ml, or 44 per cent of the recommended daily intake, were incorrect.

The commission's testing found that ready-to-drink Ribena contained no detectable vitamin C.

After the court decision, a spokeswoman for GlaxoSmithKline in London told the Daily Telegraph that the problem arose when Ribena in Australia and New Zealand was left on shop shelves for too long, causing the vitamin C to degrade.

There was no such problem with Ribena sold in Britain, she said.

"Our testing equipment in New Zealand and Australia was not sensitive enough to pick up the fact that the vitamin C was degrading," she said.

The company later issued a statement: "GSK has conducted thorough laboratory testing of vitamin C levels in Ribena in all other markets. This testing has confirmed that Ribena drinks in all other markets, including the UK, contain the stated levels of vitamin C, as described on product labels."

Professor John Birkbeck, from Massey University's Institute of Food Nutrition and Human Health, dismissed the spokeswoman's claims.

"If they're properly sealed ... the vitamin C should be fairly stable. I'm not convinced by that argument at all. Anyhow, there's use-by dates on those things. If that is really the reason, and I seriously doubt that it is, then there's something wrong with the use-by date."

As a rule of thumb, nutrient levels in products had to be within 10 per cent of the level on the nutrition content label.

Dr Carolyn Lister, from Crop & Food Research, said the accuracy of the nutrient labels could vary.

"A good company will use a value on the label that is at the end of the shelf life. If you buy a batch that's fresh, you might actually get a level that's a bit higher than stated."

She said vitamin C was one of the more easily destroyed vitamins.


MEMORABLE GSK QUOTES

After the court decision, a spokeswoman for GlaxoSmithKline in London told the Daily Telegraph that the problem arose when Ribena in Australia and New Zealand was left on shop shelves for too long, causing the vitamin C to degrade.

There was no such problem with Ribena sold in Britain, she said.

"Our testing equipment in New Zealand and Australia was not sensitive enough to pick up the fact that the vitamin C was degrading," she said.

The company later issued a statement: "GSK has conducted thorough laboratory testing of vitamin C levels in Ribena in all other markets. This testing has confirmed that Ribena drinks in all other markets, including the UK, contain the stated levels of vitamin C, as described on product labels."


Now correct me if I'm wrong... please do, because I am totally dumbfounded at the response of GSK. Do they think the public are completely devoid of any intelligence?

Are we, the UK consumer, expected to believe that cartons of ribena can lose their vitamin C if left on the shelf too long? Not only that but this can only happen in New Zealand or Australia?

This pathetic attempt at covering up the truth is a classic GSK trait.

You lied - end of story

Wonder if the MHRA would be interested to learn of GSK's stance on ribena in the UK?

Be great if one of the regulars readers on here could contact them and ask them to comment.

What's the betting that the answer the MHRA will give you will be one of the following:

1. We are confident that GSK's statement about cartons of ribena is not misleading.

2. This is a matter that is currently under investigation

3. Under the exemption rule we are not obliged to answer your query.

Transparent? About as transparent as the colour of ribena!

Bob

Liebenagate - How GSK were rumbled by two 14 year olds.

TESTING VITAMIN C

"It's in the blackcurrants" GSK Spokesperson

GMC - General Medical Council

Today I have lodged an official complaint to the GMC about the following Healthcare Specialists:

Dr Alistair Benbow (Glaxosmithkline)
Dr June Raine (MHRA)
Dr Ian Hudson (MHRA)
Professor Alistair Breckenridge (MHRA)
Professor Kent Woods (MHRA)

I, along with my trusted collegues, aim to prove that they have all at one time or another shown utter incompetence regarding the safety of patients (both adults and children)

The proof is overwhelming.

I will keep you posted on this matter.

Bob

Friday, March 30, 2007

MHRA... A step in the right direction?

Never thought I'd say this but I have to applaud the MHRA for recently requesting public comments on how they run the agency. Although not widely publicised, you, the patient, can now have your say into matters regarding the running of the MHRA.

GO HERE

Obviously, I saw this as a great opportunity so I read through the word document that explains the framework of the MHRA (HERE) and added my comments which were then forwarded to the email address provided within the document.

I can't help but feel that the recent onslaught of Seroxat blogs and support groups has had something to do with this. It is, however, a crying shame that we, as members of the public, have to have our voices heard through websites, blogs, forums before any action is taken.

I doubt very much if my comments will be publicised because they are more or less negative into how the MHRA are currently run and let's face it, the MHRA have a history of ignoring negativity.

I have therefore made the decision to post my comments on here for your perusal. That way, every man and his dog can see a differing opinion to the one that will no doubt be published by the MHRA.

As ever, my responses are in blue text.

Bob

----


Making Regulatory Decisions about Medicines and Medical Devices

Dear Mr Watkins,

Thank you for allowing further comments to this document. Below I have added comments under each question (in blue text). I would be grateful if you could take on board some of these comments.

Meantime, I look forward to your reply.

Regards
Mr Robert Fiddaman
Birmingham, UK



A. What kinds of decisions are made about safety, quality and performance?
The Agency makes a range of regulatory decisions. They involve answering questions such as:

1 Do the design and conduct of clinical trials for medicines and medical devices provide acceptable levels of protection for participants?
Taking the recent TeGenero study into account I would suggest not.

2 Should a medicine or medical device be allowed on to the market in the first place? In effect, should it have a licence or CE-mark, or not?
Absolutely not. Would you buy tyres that hadn't been given a safety check first?

3 Once on the market, should a medicine or medical device remain there in the light of new information about its benefits and/or risks, or about the quality of manufacture and supply? If so, should its use be restricted or changed?
It should be removed from the market until it the 'new claims' have been thoroughly and rigorously investigated. If the medicine in question has been claimed to show addictive qualities then current patients on the medication should be allowed to continue. However, whilst under investigation, the medicine SHOULD NOT be prescribed to 'new' patients.

4 How can we ensure that we receive enough reliable information from healthcare professionals, patients and the public, as well as from companies, about adverse events with medicines and devices?
By adding your contact details to every Patient Information Leaflet. But more importantly by advertising in doctors surgeries, hospitals and the media.

5 When new information becomes available about adverse effects with a medicine or medical device, what extra advice or warnings should we or companies issue to healthcare professionals or the public, with what urgency and through which channels?
A full page spread in the popular tabloids and announcements on the TV and radio. A small news release is not enough.

6 If we become aware that a medicine or medical device is inappropriately or incorrectly used, or is inadequately maintained, sterilised or tested, what advice should be given or what other action should we or companies take?
Again, the public should be made aware and steps should be taken with immediate effect to rectify the problem.

7 How widely available should medicines be? Should a product be available for purchase from any shop, available only under the supervision of a pharmacist, or available only with a prescription?
The claims that Seroxat cures shyness would have had queues of people buying the drug over the counter. Drugs in this class should remain prescription only drugs. In fact, any drugs with 'severe' side-effects should be prescription only.

8 Where can a medical device be used with adequate safeguards? Can a product be used at home or should it only be used in the hands of a competent practitioner?
Logistically, this is impossible to impose. If the 'device is unsafe then measures should be taken to make the device safe again before it is allowed to be used at home.

9 Is the supporting information for professionals and the public about a medicine or medical device appropriate, readable and fit for purpose, or should it be improved?
Absolutely not. The Patient Information Leaflet on Seroxat for example is misleading and does not emphasise enough the severe side-effects this drug causes. There are probably many other drugs too. The PIL needs to be seriously looked at and NOT with the help of the pharmaceutical company who are marketing the drug either!

10 Are advertising or marketing claims for medicines justified and targeted at appropriate audiences?
No. Advertisng and marketing claims are false and misleading. The whole world and their dogs know this and I can't honestly see why the MHRA are so blinkered on this issue.

11 How can we best ensure that pharmaceutical companies and device manufacturers meet their legal obligations in respect of medicines and medical devices?
Remove from the MHRA any member that has or ever has had ties with any Pharmaceutical company. You currently have two on board at present who worked closely with Seroxat. Alisdair Breckenridge and Ian Hudson. For a start they need to be removed. I'm sure there are others who are former employees of Pharmaceutical companies.

12 How can we prevent or disrupt the supply of unauthorised or counterfeit medicines and medical devices? And how can we discourage inappropriate sales of second-hand devices?
A law change is the only way. The Government need to impose custodial sentences for anyone supplying counterfeit medicines.

13 What information in relation to our decisions can and cannot, for legal or other reasons, be made public? How do we strike a balance between the need for openness and the need to respect commercially sensitive information?
This should not be your choice. How can you make amendments or rules that suppresses information to an ever increasing public who have no faith in the medicines regulator? By doing so you are lengthening the gap of mistrust.


B. What principles inform decisions about safety, quality and performance?


1 Medicines and medical devices bring widespread benefits for patients and the public but no product is free of risk. Many decisions involve the weighing of risks of harm against the likelihood of benefits. If a product is available for use, its risks must be acceptable in relation to the potential benefits to patients and users.
..and must be clearly stated when before the patient agrees to take on the medicine or medical device. At present this is clearly not the case.


2 Some risks will be known when a product goes on the market but others will only become known later when it is widely used, especially if the adverse effects are rare.
RARE? You are having a laugh
1.
www.paxilprogress.org
2. http://news.bbc.co.uk/1/hi/programmes/panorama/2982797.stm
3. http://news.bbc.co.uk/1/hi/programmes/panorama/2310197.stm
4. http://www.bbc.co.uk/pressoffice/pressreleases/stories/2003/05_may/11/panorama_seroxat.shtml
5. http://fiddaman.blogspot.com/
6. http://www.breggin.com/articlessummary.html
7. http://health.groups.yahoo.com/group/seroxat/
8. http://paxilfree.org/
9. http://web.archive.org/web/20040212065420/news.bbc.co.uk/1/hi/wales/north_east/2982056.stm
10. http://www.mind.org.uk/Information/SeroxatOMarticle.htm
11. http://news.bbc.co.uk/olmedia/cta/progs/03/forums/panorama/seroxat11may.ram
12. http://news.bbc.co.uk/media/video/39429000/rm/_39429728_seroxat_baldini_vi.ram
13. http://seroxatforever.wordpress.com/2007/03/07/hello-world/#comments
14. http://seroxatkillsbabies.wordpress.com/
15. http://shutah.wordpress.com/2007/03/04/sunday-3-march-2007/
16. http://bux2222.wordpress.com/%20Seroxat,%20The%20Damage%20is%20Done...%20Now%
17. http://news.bbc.co.uk/media/video/39429000/rm/_39429732_seroxat_disco_vi.ram
18. http://seroxatsecrets.wordpress.com/
19. http://www.sharisegatchell.com/
20. http://www.socialaudit.org.uk/
There are many, many more... and well you know it!

3 Decisions will be based on good science and robust methodology. Judgements on safety, quality and performance will be informed by all available, relevant and reliable evidence, with the burden of proof often resting on companies.
In other words.. Pharmaceutical companies can give the MHRA the data that is positive and NOT negative. What a proposterous way to safeguard human health!

4 A cautious approach to a decision will be needed where there is scientific uncertainty about the existence or extent of a risk but reasonable grounds for anticipating the possibility of severe adverse effects.
How many years will it take to investigate? Who will be responsible for the deaths and severe side effects bestowed upon the general public?

5 The Agency is concerned about the safety, quality, performance and use of a medicine or device throughout its life. The Agency will continue to seek and require additional information on risk and benefit, particularly since the initial authorisation or compliance with requirements may have been based on limited information. If the relationship between risk and benefit changes, so may the approval or classification of the product, or the advice to prescribers and users
Complete poppycock! As long as you have former Pharmeceutical employees employed by the MHRA you will continue to robustly deny any wrong doing by their former employers because it will clearly highlight the incompetence of the MHRA.

6 The Agency is committed to the principles of equality, and will not improperly or arbitrarily discriminate, for example on the basis of age, sex or race. However, the initial and ongoing approval of a product will legitimately take account of factors such as age, sex or race, particularly if any of these populations is a specific target for benefits or poses specific risks. So, for example, the effects of a product on children, on the elderly or in pregnancy may require explicit consideration.
Tell Breckenridge this - also have a word with Dr Benbow at GSK regarding their comments on the safety of Seroxat in adults. Benbow was even quoted as saying Seroxat was safe for children! Dr June Raine was also warned of the dangers as long ago as 2000

7 The financial cost of a product does not enter into the Agency’s decision-making processes, though bodies such as NICE and the NHS are properly concerned with costs
Unless of course it effects the financial interests of MHRA members?

8 The Agency’s decisions will as far as possible take account of the known views of relevant stakeholders such as medical specialists and patient representative groups
Yeh, sure it will

9 Decisions will be made under processes which comply with legal obligations and in which the public can have confidence
Oh puhlease - enough of the bullshit!

10 The Agency’s decisions will as far as possible be transparent and open to public scrutiny; a reasonable person reviewing our decision should understand the rationale
HAHAHAHAHAHAHA - (My last and final correspondence with the MHRA saw Mr Tim Berridge totally blind me with science. In fact a biological scientist would have had trouble reading the content of his 'transparent' answer to me)

11 If the Agency withholds information because of legal obligations such as the requirement to protect confidentiality, it is ready to give its reasons for doing so.
Yes, I and many others have heard these reasons - Exemption rule this, exemption rule that - purely rules invented to keep the public from knowing the truth.

12 The staff of the Agency and the members of its Advisory Committees are not influenced in their decisions by financial or other interests in the industries concerned.
Absolute and utter rubbish!



C. What questions should be considered to ensure that reasonable decisions are made?
We do not expect that all these questions will be considered in all situations or that there will be simple yes or no answers to many of them. The list is not exhaustive, and other questions may be relevant.


1 Does the product work and offer useful clinical benefit if used in its specified way?
Is there robust evidence that the product will do what the company says it will do?
On that basis the MHRA are in total agreement that Seroxat is safe in adults - despite the papers of Dr Peter Breggin that suggest otherwise.

2 What impact will the product have, or is it having, on both the quality and length of life in those patients who are treated with it or on whose behalf it is used?
Go to the websites (see Q, B2) and then YOU tell me

3 Has the manufacturer demonstrated that it can consistently and reliably make the product to the required level of quality?
Has the manufacturer demonstrated the data it supplied to the MHRA showed negativity as well as positivity?

4 Does the evidence available before a product is marketed give a clear indication of all adverse effects that have been discovered, the likelihood that they will occur and their severity?
In Seroxat's case, NO - Yet the MHRA still granted a licence for it.

5 If the evidence on safety, quality or performance is uncertain or unclear, is more needed before a decision can be made?
How much 'more' do YOU want? You have been sitting on Seroxat information for over 7 years!

6 Is there relevant evidence about everyday use of this or similar products, or do we need to seek such evidence?
A scientifically excellent clinical trial is of limited value if its design does not reflect the likely use of the product in everyday situations
Yes, SSRi's can cause suicide in both adults and children - You must do your homework

7 From knowledge of how the product works, is it possible to predict other adverse effects that may occur when the product is used with larger and wider groups of people, or in conjunction with other products? If so, are there clear plans in place to track and manage the risks?
Obviously not in the case of the MHRA - or Seroxat would have been pulled some time ago.

I think you get the message. I doubt very much if any of my comments will be taken on board. Your framework is commendable - Your ethics stink. You have far too much in common with the pharmaceutical companies whose drugs you are supposed to regulate. The general public have little or no confidence in you because of this.

8 Can the risk of adverse effects be limited by restricting the product’s use to specific groups of patients, or to particular dosages or durations of use?
There should be no risk of 'adverse' effects. All drug data should be properly scrutinised before a licence is granted to the company

9 What risks are associated with the condition the product is designed to manage?
Do the risks of not treating the condition outweigh the risks associated with the product? Is it a very serious/debilitating condition, or a mild and self-limiting one? Greater risks may be acceptable for products that markedly reduce suffering or treat life-threatening conditions, especially those for which no other effective treatment is available
It's alright asking these questions... I honestly have to ask myself whether or not the MHRA actually answer them as there seems to be an awful lot of 'bad drugs' being prescribed to patients here in the UK.

10 Can the Agency accept less evidence on which to base its decision if the rarity of the clinical condition means that more detailed evidence cannot reasonably be gathered?
Absolutely not! Would you let someone babysit your child without first doing a background check on that person?

11 Is the Agency prepared to accept early and limited evidence on which to come to a decision if a product, while appearing to have acceptable risks, offers significant or urgent benefits to public health or outstanding benefits to patients?
Based on the evidence the Pharmaceutical companies give you then yes. But you have to remember that their goal is to make money. Any risk will be played down and spun in such a way that only benefits the manufacturer. This IS NOT why the MHRA was set up!

12 Are there, or can there be, warnings for the public as well as for healthcare professionals about the nature and likelihood of adverse effects, warnings that are understandable and specific enough for them to make informed choices or to restrict the usage?
If not, how else might the risks be managed? Would it be better not to allow the product to come onto or to remain on the market, or to restrict its availability?
Cigarette boxes are straight to the point with their warnings - The public have a right to know that anything they consume or administor can be life threatening. This should not even be up for debate!

13 Does the Agency’s decision take account of the views of the public about the balance between risks and benefits? Should it, if the public’s views are in conflict with robust and comprehensive scientific evidence?
The MHRA only listen to the Pharmaceutical Companies. For years the MHRA have been recieving reports from the public about serious withdrawal problems from SSRi's. I, for one, have been banging the drum loudly in speaking out against Seroxat as have countless others, including Charles Medawar, David Healy etc. What has the MHRA done about this? - Absolutely nothing! Shameful.

14 Does the Agency need to seek further views from relevant parties?
In addition to the scientific evidence, do we need views from healthcare professionals, organisations concerned with specific conditions, and/or patients who have used the product?
Once, again, this question should not even be up for debate. It's common sense to find out as much information as possible about something you are about to grant licence to. Currently the MHRA grant licence to a drug based on positive data they recieve from the manufacturer. With ex employees of that manufacturer working for the MHRA it comes as no surprise that drugs will eventually be found to cause adverse reactions to the patient. You have to remove ex pharma employees from the MHRA immediately. Making press statements regarding ex employees having to leave the rooms when certain drugs are mentioned does not dupe the public. Get rid - and restore faith in the public - until then the MHRA will always be seen as Pharma's left arm.


D. Who makes the decisions?


1 There are three main groups within the MHRA involved in regulatory decisions about the safety, quality and performance of medicines and medical devices:

2 · Staff – the Agency’s professional staff make many decisions about the safety and performance of medicines and medical devices on a day-to-day basis, and about the quality of manufacturing and distribution. An Executive Board of senior staff oversees the work of the Agency and takes ultimate responsibility for the decisions made.

3 · Advisory Committees – groups of independent experts and lay representatives who advise on whether medicines and devices work and are acceptably safe, based on an evaluation of all relevant evidence, including that from the Agency. These groups include the Commission on Human Medicines, its Expert Advisory Groups, and the Committee on the Safety of Devices.

4 · The Agency Board – which is made up largely of external members, acts in a supervisory and advisory capacity and has a particular role in assuring the quality of decision-making.
All of whom have failed to regulate Seroxat in the use of adults. All of whom have review after review robustly denied there is any link to Seroxat and suicidality in adults despite the overwhelming evidence. The majority of staff will have ties with pharmaceutical companies too - This is proposterous!

5 In law, decisions by the Agency are decisions of the Secretary of State for Health who is accountable to Parliament. Ministers also make decisions on matters of significant public concern from time to time, advised by the Agency or its expert committees.
The people from the MHRA that advise the Sec of State are either ex-employees of Pharmaceutical Companies or have a financial interest in Pharmaceutical Companies. Patient support groups should offer advise to the Sec of State because we are the guinea pigs and have no vested interest in Pharma

6 There are other organisations and bodies outside MHRA which are also concerned with safety, quality and/or performance, principally in that:

7 · Organisations called Notified Body carry out a compliance assessment before manufacturers can place certain medical devices on the market.

8 · Many decisions made by or within other Member States of the European Union and by the European Medicines Agency must be respected or taken into account within the UK, just as decisions of MHRA can have an impact on other Member States. Experiences of problems are also shared in both directions.
Problems may be shared with Directors but little or nothing has ever been done about them, particularly in the case of Seroxat!

9 · Clinical trials of products are subject to the approval of ethics committees, complementing the role of MHRA, which is principally concerned with the scientific evidence.
An absolute nonesense! If the MHRA were concerned of the scientific evidence they would ask for RAW data to be presented to them, apparently this is not the case

10 We do not and should not have direct influence over ethics committees or European partners but recognise that their decision-making often follows similar principles; where we have cause for concern about decisions taken by others, we make that known through appropriate channels. A 'Dear Doctor' letter is NOT useful to the patient. Some Doctor's will ignore these letters because they too have targets to meet regarding the promotion and selling of drugs.

11 It is for doctors and other healthcare professionals to determine the suitability of particular medicines or medical devices for patients under their care, weighing benefits against risks and considering costs subject to guidance from the NHS and NICE.
This is a total cop out. On this premise it is an utter waste of time that the MHRA were set up. If the regulator did it's job in the first place the onus would not have to be put on GP's and Healthcare specialists to make a decision about the safety of a drug in a particular type of patient's illness. This is nothing more than passing your responsibilities over to someone who has even less knowledge about the drug than the actual regulator. What a complete farce!

12 Patients and the public will often have their own views about the suitability of particular medicines or medical devices. They are usually free to decide for themselves whether to use the products or not, supported by reliable information about risks and benefits.
How naive the MHRA must be. Yes, the public have a choice but that choice is taken away when the drug they take causes severe withdrawal that they have no option but to keep taking it.

13 We encourage both patients and healthcare professionals to report adverse events, through the Yellow Card scheme for medicines or Adverse Incident report forms for devices. These reports are important to the Agency, which analyses them alongside other new sources of information to determine whether action is needed.
Great idea on paper but does it really work? If the CEO of the MHRA personally believes a drug is safe then any yellow card report WILL NOT alter his opinion. The yellow card reports are followed up on a 40-50% basis - This IS NOT good enough - too many reports are either slipping through the net or are purposely ignored because they show that the regulaor has failed - personally I choose the latter.


I doubt very much if my comments will be taken on board because the MHRA, it seems, refuse to accept negativity. Such is the power of the internet though, these comments WILL be posted if no feedback is recieved. The public have a right to know. If the MHRA continue down the path they are going then the Patient support groups will get louder and louder.

There is a cancer running right through the Medicines Regulator - this cancer, however, is treatable - if it goes untreated it will be the demise of you. Remove members from the agency who have close ties with Pharma. Investigate (impartially and independently) every patient report. Set up a team to read patient support groups and to work with them and NOT against them and act with immediate effect when evidence comes to light that a manufaturer has been lying to you.


The following will be published on http://fiddaman.blogspot.com in the near future.

Yours sincerely
Mr Robert Fiddaman

Birmingham, UK

Thursday, March 29, 2007

Paroxetine - The Patients

You will see from the following links that GSK must have recieved reports from as far back as 1992 about severe side effects with their wonder drug Seroxat/Paxil. Because these are in the public domain then The MHRA and FDA would have known too. The action that was taken?

NONE.

Shameless

Kudos to http://www.antidepressantsfacts.com for these statistics

1992 - Extra pyramidal side effects associated with paroxetine.

1996 - Hyperglycemia Associated with Paroxetine

1996 - Paxil/Seroxat (paroxetine) induced bruxism (teethgrinding)

1998 - Hyponatremia associated with paroxetine

1999 - Severe life-threatening hyponatremia during paroxetine therapy

1999 - Risk factors for falls during Paxil/Seroxat treatment of late-life depression

There are many more to read - I'm sure they have all been glossed over at one time or another by Messrs Raine, Benbow, Hudson, Woods, Breckenridge and the other muppets who continue to deny that what you and I have been given is a highly dangerous and toxic drug.

MORE HERE

White Plains woman sues doctors, drugmakers over husband's suicide

**Snip**

... The suit targets the hospitals, along with various doctors and drug manufacturers, including GlaxoSmithKline, Forest Pharmaceuticals, Forest Laboratories, Myland Pharmaceuticals and Teva Pharmaceuticals USA.

...."Obviously, some of them are probably more responsible than others, but if I left anyone off, I could miss someone," Arbizo said. "Paxil in particular is what I'm interested in. Paxil had an integral part of what the decedent faced."

FULL STORY HERE

Glaxosmithkline Liebena Scandal

Some oh so familiar quotes from GSK in this news story.

Before the court case

AFTER 55 years of telling porkies, Ribena has finally sent itself to the naughty corner. But the surprise mea culpa may not save the drink's maker - and the world's second-largest pharmaceutical company - from receiving a thorough caning in a New Zealand court next week.

Generations of Australian and New Zealand children have been raised on Ribena, because that nice lady on telly told them the blackcurrants in the purple stuff contained four times the vitamin C of oranges.

But Ribena's manufacturer, the pharmaceutical company GlaxoSmithKline, has in effect dobbed itself in to the national competition watchdog for "allegedly misleading representations" and has already undertaken to remove all references to vitamin C on its product's label.

In a statement released by the Australian Competition and Consumer Commission yesterday, the chairman, Graeme Samuel, emphasised that GlaxoSmithKline had "self-reported the discrepancies".

A matching statement by the company also emphasised the voluntary nature of its confession. The company omitted to include, however, the impetus behind its earnest and apparently voluntary bid to set the record straight.

The commission's equivalent across the Tasman, the New Zealand Commerce Commission, has been investigating GlaxoSmithKline for more than a year, and next Tuesday the company will face more than 80 charges in the Auckland District Court of allegedly making misleading representations involving Ribena.

The Herald understand the charges relate to vitamin C claims made on the packaging of Ribena ready-to-drink cartons and to vitamin C claims made in television advertising and packaging for its syrup, which has been on the market for more than five decades.

GlaxoSmithKline told the Herald late yesterday that the New Zealand investigation had been "a trigger" in its decision to approach the consumer commission here.

So had the multinational British-based pharmaceutical company - which turned a profit of more than $17 billion in the last financial year - been "allegedly misleading" its customers for the past five decades?

Absolutely not, a spokesperson said in a written statement forwarded to the Herald.

"Weight for weight, the 'four times' statement is factually correct but **we accept that there is a potential for confusion among consumers and have taken the action to remove that claim."

In January, the Herald reported an analysis of popular children's snack foods and beverages by the independent consumer watchdog Choice, which found that Ribena consisted of little more than sugar and water. Its essential ingredient - blackcurrants - made up just 5 per cent of content, the study found, and was a processed product made from concentrate.

"For years, manufacturer GlaxoSmithKline has led Australian parents to believe Ribena fruit drink was a healthy choice for kids because of its vitamin C content," said Choice's senior food policy officer, Clare Hughes.

"This is a good example of food marketing manipulating busy parents who want to provide the best for their kids."



** We accept that there is a potential for confusion among customers and have taken the action to remove that claim

Hmmm - Sounds so familiar eh?


After the court case

Food health claims under spotlight after Ribena case

The case against Ribena has heightened concerns that misleading health claims are being made for a range of foods, says marketing professor Janet Hoek.

GlaxoSmithKline was on Tuesday fined $227,500 in the Auckland District Court, for misleading claims about the levels of vitamin C in Ribena.

It was ordered to place corrective advertising in newspapers after admitting 15 breaches of the Fair Trading Act.

GlaxoSmithKline admitted that its ready-to-drink Ribena, which its labelling said contained 7mg of vitamin C per 100ml, in fact had no detectable vitamin C content.

It also admitted it might have misled customers in advertisements saying the blackcurrants in Ribena syrup had four times the vitamin C of oranges.

When properly diluted, Ribena has about 1.5 times the vitamin C of comparable orange drinks. Tests have also showed it has more sugar than Coca-Cola.

Professor Hoek said there was a danger the incident would be seen in isolation, when there were lessons to be learned.

"It doesn't take more than an educated guess to realise that other food products marketed as beneficial to health, for example by being low in fat or sugar, may also be misleadingly or deceptively labelled."

The use of health-related claims had a very clear potential to mislead and deceive consumers, she said.

"The Ribena case highlights the need for clear food labelling such as a traffic lights system, where consumers do not need to interpret complex nutrition information before making a purchase decision."

It was disturbing that schoolgirls Jenny Suo and Anna Devathasan, who did the initial tests on the product in 2004, said they were brushed off when they took their findings to the company, the Advertising Standards Authority and marketing organisation Brandpower, she said.

However, consumers were now more aware of the danger of obesity and the importance of having access to correct and easily accessible information about food.

People were exposed to many advertising claims, at least some of which they accept at face value, she said.

"Consumers become conditioned to respond to claims such as 'lite' or 'high-fibre', which imply a product is healthy when it may, for example, contain very high sugar levels.

"Marketers are adept at using puffery to imply benefits that do not exist."

She called for more research to explore how consumers accessed, used, understood and responded to health claims.

Professor Hoek has researched consumer deception and public policy issues, including the effects of food marketing on obesity, and the impact of misleading descriptions on tobacco products.

Meanwhile, Charlie's Trading Company owners Marc Ellis and Stefan Lepionka have offered Miss Devathasan and Miss Suo work experience at their juice company.

"At Charlie's we applaud honesty, so we want to give those two teenage Kiwi girls work experience at our company," Mr Ellis said.

"It took these two trustworthy teenagers to triumph over the giants of our industry and out the truth on one juice company to consumers at last.

"With other companies out there committing similar claim-crimes, we reckon these girls could make a healthy career out of it."

Charlie's had spoken to Pakuranga College to discuss the girls coming to the company.


LIARS!!!

LIARS!!!

LIARS!!!

Wednesday, March 28, 2007

Amendement and Apology

In my rush to post the Paxil 329 Study files (HERE) I actually forgot to name the source of where I obtained them. The site is the brilliant Healthy Scepticism and can be found HERE.

Healthy Skepticism is an international non-profit organisation for health professionals and everyone with an interest in improving health. Their main aim is to improve health by reducing harm from misleading drug promotion.

I apologise to them for not giving credit where it was due and would like to thank the person who pointed this out to me.

Bob

LIARS! Glaxosmithkline fined $217,500

Small change to a company whose annual turnover runs into the billions.

Nevertheless, they have once again been caught out... this time by two 14 year old schoolgirls
Schoolgirls celebrities after exposing Ribena

Makes you wonder if the placebo pills they use in clinical trials are actually 'placebo'

LIARS

Tuesday, March 27, 2007

For GSK & The MHRA

Karma is a sum of all that an individual has done, is currently doing and will do. The results or "fruits" of actions are called karma-phala. Karma is not about retribution, vengeance, punishment or reward, karma simply deals with what is. The effects of all deeds actively create past, present and future experiences, thus making one responsible for one's own life, and the pain and joy it brings to others. In religions that incorporate reincarnation, karma extends through one's present life and all past and future lives as well. It is cumulative.

Sleep well

Fid

Dr June Raine, MHRA knew 7 years ago!



Dr June Raine of the MHRA knew of the severe side effects of Seroxat as long ago as 7 years ago and STILL nothing has been done.

Dr June Raine is the Director of the Post-Licensing Division at the Medicines and Healthcare Products Regulatory Agency (MHRA) and her responsibilities include all the issues that relate to medicines once they are authorised for use on the market.

Now, you have to ask yourself two fundamental questions here. Firstly, Dr June Raine is still the Director of the Post-Licensing Division at the MHRA - Why?

And secondly... Why have no criminal charges beeen brought against her?

Do members of the MHRA think they are above the law?

Do members of the MHRA think they are a priest in a confessional box and information relayed to them by the person confessing (in this case GSK) is sacred and cannot be shared?

Below I will show you correspondence that was sent to Dr June Raine in the year 2000 - 7 years ago!

The MHRA are always waffling on about how they take adverse reaction reports seriously. They point to the Yellow Card scheme like it was some sort of final say on all matters. They claim to listen to patient reports - Have they ever visited Paxil Progress to see the problems folk from all over the world are having with Seroxat? Or do they only count reports they recieve? Have they ever googled the word 'Seroxat' and been faced with the mind-blowing patient stories of withdrawal, addiction, agitation, murder, suicide, zaps etc?

Anyway, I'm going off on a tangent here - The main purpose of this post is to show YOU - the sufferers, just how incompetent Dr June Raine has been regarding her job responsibilities.

On June 7th 2000, Dr David Healy sent the following letter to Dr June Raine, this letter, along with the thousands of reports she and the MHRA collectively have recieved since clearly highlights that Seroxat is a defective drug. I have highlighted points in red text that should have sent alarm bells ringing in Dr Raine's head... they obviously didn't!



Dr June Raine, Director of
Post-Licensing Division, MCA
Market Towers, 1 Nine Elms Lane
LONDON SW8 5NQ

7 June 2000

Dear Dr Raine,

You may or may not have heard that yesterday in Cheyenne, Wyoming a Court found Glaxo SmithKline guilty on several accounts including the count that Paroxetine can cause suicidality, that it specifically did so and contributed to the wrongful death of Don and Rita Schell as well as Deborah and Alyssa Tobin and that the company had been responsible for a failure to test and a failure to warn. You may also be aware of a verdict in the Hawkins case in New South Wales some weeks ago where a Supreme Court Judge made it clear that in his opinion Mr David Hawkins would not have murdered his wife but for the influence of Sertraline.

In the course of my work as an expert witness in Tobin versus SmithKline I got the chance to look at SmithKline's healthy volunteer database in Harlow. Their characterisation of this for you was that: "There were no reports of suicidal thoughts in any of the volunteer studies. There were few reports of 'emotional lability', however these reactions were not found to be related to suicidal thoughts or behaviour. Some volunteers reported anxiety, nervousness and agitation while taking paroxetine, however the most commonly reported adverse events were nausea, diarrhoea, drowsiness and insomnia".

What I found was that approximately 25% of the volunteers in the studies that I reviewed which were all of the healthy volunteer studies done prior to the filing of this drug for registration in the US and in the UK - 34 studies approximately in all. These yielded a 25% agitation, nervousness/akathisia rate. Some of the multiple does studies in healthy volunteers lasting 2-3 weeks yielded an up to 85% withdrawal rate in the volunteers.

All of their healthy volunteer studies were supposed to have been made available to me but not all were. Of the ones that were missing there was trace correspondence left in once indicating that the investigator had never witnessed such a level of problems in a study with healthy volunteers. Another study was a single dose study which in a dose dependent fashion yielded a 75% rate of severe adverse events most of which involved the central nervous system. There were other disturbing indications from one of the other missing studies.

Volunteers who had participated in the programme went on to suicidal acts. The relationship between their intake of paroxetine and later suicidal acts is a matter about which neither you nor SmithKline Beecham should be sanguine.

These studies were for the most part done on company employees. None of the studies bar the missing ones were done by investigators with a background in psychiatry. The investigators were general physicians with a primary interest in gastrointestinal problems who could not have been expected to detect mental problems of this sort that have concerned me and I would have thought should concern you.

My testimony in this case also bore witness to sealed studies and other unreported data. It commented on the Montgomery Baldwin Study which yielded a projected rate of 45 suicide attempts in a group of recurrent brief depressive disordered patients on paroxetine per annum versus 12 on placebo. The figures were not statistically significant in great part one has to suggest because the company had terminated the study early. This termination and subsequent non-publication I would imagine the jury will have found and others will find significant.

Dr Hudson, currently of the MCA, was a witness for SmithKline in this case. He may well be able to give you further details on some of the issues involved. His testimony involved repeated reference to the fact that SmithKline Beecham cannot decide whether their drug had caused problems such as the wrongful death of Don and Rita Schell or Deborah and Alyssa Tobin or the wrongful deaths of many other people whose deaths have been reported to SmithKline even when these reports have been accompanied by the opinions of their treating physicians that the drug had indeed contributed to the problem. Dr Hudson's testimony was that until controlled trials or other similar studies had proven in general that paroxetine could cause such problems that the company could not make decisions on any specific case.

This appears to me a Black Hole defence. It is entirely conceivable that tens of thousands of suicides could disappear into this Black Hole without either SmithKline Beecham, Pfizer or Eli Lilly being called upon to make any judgements as to whether their drug was contributing to the problem. The lack of evidence from randomised controlled trials or epidemiological studies in this context is not evidence of a lack of a problem. It stems explicitly from failures of SmithKline Beecham, Pfizer or Lilly to do the requisite studies. Both David Wheadon and Christine Blumhardt from SmithKline as well as Roger Lane from Pfizer and Charles Beasley from Eli Lilly along with outside experts such as Daniel Casey and John Mann have testified under oath in the course of the last year that there have been no studies undertaken by any of these companies or others that have been designed to test whether the SSRIs could cause a problem. I believe that this will in due course be seen for the extraordinary state of affairs that it is.

I think what will also be clear is that SmithKline Beecham recognised the presence of withdrawal syndromes in their volunteers from the early to mid 1980s. That withdrawal syndromes occurred at a much higher rate than occur on benzodiazepines. Nevertheless they applied for and have received from you and other regulators a licence to claim that their drug is effective in the prophylaxis of depression and these claims have been based on designs which almost certainly are designs better suited to show the presence of a withdrawal syndrome than designs suited to demonstrate prophylaxis in depressive disorders. A great number of people have in recent years been told that when they begin to feel ill on discontinuing treatment that this is the recrudescence of their mood disorder rather than a discontinuation syndrome from their drug. I would imagine that a great many such people and others on their behalf will feel extraordinarily let down and angry when faced with the evidence that I've been faced with.

Yours sincerely

David Healy MD FRCPsych
Director, North Wales Department of Psychological Medicine

Just think of all the lives Dr Raine and the MHRA could have saved if they had acted upon this letter (one of many letters I might add)


I find it totally unacceptable that these clowns are deciding what drugs are safe for us to take.

Dr Raine along with Woods, Breckenridge, Hudson and the other muppets at the MHRA should be held accountable for the suffering this drug has caused us all.


You are all a total embarrassment and devoid of any conscience.


May Dr Raine & Co beg for forgiveness on their day of judgement... The God I beleive in would place you ALL in an elevator and press the ground floor button.


Monday, March 26, 2007

GSK/MHRA - The Screenplay

GSK HQ - Brentwood, England.

BENBOW: May I have your attention please folks

The crowded room look toward the figure of Dr Alistair Benbow standing on the platform. The room suddenly falls into silence.

BENBOW: Firstly, I would like to thank you all for attending this meeting at such short notice and I apologise for you all having to remove your clothes on entering the room... one can't be too careful when it comes to speaking about our baby Seroxat.

The congregation break into laughter and one individual, carried away by Dr Benbow's humour, shouts, 'YOUR'E THE MAN ALI'.

BENBOW: Thank you, thank you. Now, I'll try to be brief, I know you will all be dying to put your clothes back on. A lot of you may already be aware of the increased bad publicity we are getting regarding Seroxat. Breggin, Medawar, Joffre, Healy, Pringle, Bosley... to name but a few. It has recently come to our attention that there are a growing number of patient blogs springing up. Our lawyers are looking into ways that we can shut these down - they did it before with the Paxil Protest site but this time are looking at ways to shut these people up without actually having to pay them.

As you are all aware we have a great allies in the MHRA... and I'm not talking about my good friend 'Ally' Breckenridge. (Audience breaks into laughter).

Thank you, thank you.

It seems these blogs are finding evidence that ties us in with the MHRA and certain individuals that used to work here at GSK. I've spoken with both Alistair Breckenridge and Ian Hudson and they have both assured me that they are not concerned as they know once our lawyers settle the litigation that these 'rumours' will die a death.

Anyway, I have gathered you all here today for a very special reason. Ladies and gentlemen, I have gone on for too long. Without further ado I would like you all to stand and bow your heads and pledge alliegance to the great one. Comrades, I give you Our Lord Garnier.

The gathering stand open mouthed as GSK's Cheif Executive, Jean Paul Garnier walks to the platform.

JP: Bonjour... or should aye say in ma perfect Engleesh - ello

The crowd laugh uncontrolably and the preceeding applause settles after 4 minutes.

JP: As you all know ve ave bin ze target of bad press recently. Ze whole Zeroxat sing has increased rapidly. Luckily for us ze patent has almost expired and ve have made millions of pounds on zis drug already so it vill not really hurt ze coffers at GSK.

*Rapturous applause from the gathered assembly.

JP: Our marketing team here at GSK have never failed to astound me with their skills. When I first learned of the Paxeeeel study 329 I immediately thought we vere in danger of losing millions of pounds. But with some stunning skullduggery our marketing team managed to spin ze truth to doctors and patients alike. Ve now have to do ze same sing all over again with ze adult trials. Already ve have made plans with ze MHRA to play down ze risks and with Alistair Breckenridge and Ian Hudson on board there I sink ve can hold off ze public for some years yet.

*Crowd laugh and once again give JP a 4 minute standing ovation.

JP: Sank you, you are too kind. Let me reassure you all zat ze recent Panorama programme vill soon be forgotten about. Ze British press have more important matters to investigate such as Big Brozzer and vat David Beckham had for lunch.

*Incontroleable laughter from crowd.

*Benbow is seen wiping tears of laughter from his face.

(Backstage)
BENBOW: Oh isn't he such a wonderful man? So charming and full of great wit.

AMERICAN: Yeh he sure is Doctor

*Benbow turns to find a scruffly looking man holding a camera.

BENBOW: MOORE.... EVERYBODY, THAT MEDDLING AMERICAN , MICHAEL MOORE HAS INFILTRATED OUR MEETING... QUICK, NAB HIM.

Michael Moore has been in this game too long, he makes for the exit before Benbow can say 'not addictive'

Back in the room chaos ensues and JP is ushered away by the two burly security guards into his waiting limousine.

JP: GET ZAT MOORE - HE HAS EVIDENCE NOW THAT WILL RUIN US.

His limo speeds away at breakneck speed and JP frantically tries to phone GSK lawyers from the limo phone.

JP: What is ze matter with zis phone, Vye is there no reception? Driver, Do you have a cell phone on you?

The driver stops the limo and slowly turns to JP.

DRIVER: Yeh, sure I do JP... sure I do.


Credits roll

MHRA and the missing files?

This segment of news was found by The Truthman who is the author of GSK: Licence to (K) ill


I have been researching into the background of The MHRA and GSK for almost four years now and when I stumble upon stories that knit the two together it only highlights what I and many others have been saying for years.


GSK and The MHRA are UNITED as one.


If you were the most stubborn person in the world you could not deny the close ties they have after reading the following article from here.


Years of denial, jobs for the boys, you scratch my back - I'll scratch yours.


Read on and tell me I'm paranoid!


The files containing the licensing history of Myodil have been ‘mislaid’ by the Medicines Control Agency. After pressure from the Myodil Action Group, which fought for an investigation, the Parliamentary Ombudsman recommended a release of the documents. However, the Permanent Secretary to the Health Department refused to release the major part of the Myodil licensing documents.


On the 19th September 1988 Glaxo notified the Department of Health that Myodil was to be discontinued in the UK for commercial reasons, but they wished to retain the product licence issued in June 1987 as the product was not being discontinued worldwide. Myodil is thus still manufactured and sold overseas - it has found new markets in countries that are vulnerable to the marketing strategy that made Glaxo one of the largest pharmaceutical companies.


Glaxo has always maintained that the links between Myodil and adhesive arachnoiditis have not been proven. But in an out of court settlement in 1995, whilst denying liability Glaxo Laboratories Limited paid out, on average, £16,000 to each of 425 claimants suffering from Myodil Adhesive Arachnoiditis. A further 3,000 claimants had to withdraw because of what many of them felt to be Glaxo's solicitors’ bullying tactics. Settling out of court meant that Glaxo effectively closed the door on any further litigation in the UK. [2000] Toxic drugs are good for you (Myodil)


The Daily Telegraph has documentary proof the Federal Government, state health authorities and doctors sanctioned the use of the dye even though they knew the devastating effects of the chemicals in it. ......"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. [2002] Medical cover-up


What is not commonly known is that the developers of the "dye", Kodak, knew it would cause CIAA before they licensed it (May 1944). Today, there are 80 medical conditions or symptoms that have been recognised as a "cause or effect" of exposure to this "too toxic" chemical dye (NIH, 1994). Many of the drugs now used to treat these secondary conditions or symptoms of CIAA have been developed or patented by those who developed the original formula (for some, with slight changes of said formula; later, for instance, Myodil by GlaxoSmithKline).


I will go on the record to state the following: the developers of the diagnostic radiographic contrast medium knew before they applied for an NDA (new drug application) that it would cause arachnoiditis, and furthermore were aware of some of the other found reactions to this "dye" that were also not reported to the authorities.


I will go further and also place on the record that the collection of "secret studies" shows such; however, none was ever submitted to the FDA when applying for the NDA. Copies of all these "secret studies" are held in a bank safe on my behalf; these can be made available to any person who is willing to publicly publish such. [Letter Nexus Dec 2006] Arachnoiditis Awareness


Thinking Blogger Award



Many thanks to Seroxat Secrets for tagging me for a 'Thinking Blogger Award'

Now I have been selected I have to nominate 5 other blogs, my first choice would have been Seroxat Secrets as it is one of the blogs I frequently visit - alas, it seems, I cannot do this so listed below are 5 blogs that make me think.

These are in no particular order and are relatively on a par with most of the other great blogs I visit.




A blog created by Vera Hassner Sharav and one that not only gets one to think but one that is inspirational - A kind of David v Goliath blog. Vera's work is tireless and I have much respect for her courage and knowledge.



Was set up by a former psych patient and focuses on mental health issues. The work on here is original and always provides great stories and rants by the author.



When the Truthman speaks you have to sit up and listen. This blog is a great timeline regarding the Seroxat/Paxil scandal - If awards were given for blog names then GSK: Licence to (K) ill would be up there with the best of them.



Addresses threats to health care's core values, especially those stemming from concentration and abuse of power. Its contributors are made up of qualified doctors.



Is the blog of Dr Pete Breggin. Dr. Breggin is the author of nineteen professional books and has been called as an expert witness for many cases regarding antidepressants. His voice has been a tremendous help in my life.



The rules for the Thinking Blogger Awards can be found here

Sunday, March 25, 2007

Objection Your Honour!

Obection! Objection! Objection!

Just answer the damn question will you!




Donald J. Farber Attorney at Law

Discovery has commenced in the lawsuit. Plaintiffs are seeking evidence: (a) that illustrates Paxil in fact causes the serious withdrawal problems we allege, and (b) that SmithKline is well aware of Paxil’s hazards. To avoid legalese, we will paraphrase and use ordinary English to convey some of the exchanges that have occurred in our discovery process to date. You will get an idea of how large corporate defendants stymie the discovery process, and effectively throw up a firewall to ward off plaintiffs. (“Q’s” are our (plaintiffs’) questions, “A’s” are SmithKline’s answers, and “notes” of ours that follow SmithKline’s answers


Q: How many complaints on Paxil withdrawal have you received since January 1, 1993?

A: We object to the question. We don’t know what you mean by “complaint” and “withdrawal” but we’ll turnover over our adverse complaint file on Paxil. (note: they have not turned over the file yet)

Q: What efforts have you made since 1993 to find out about the Paxil withdrawal problem?

A: We object to the question. We have, however, performed numerous analyses of symptoms that were reported following cessation of Paxil therapy. We will provide you documents on these entries if you agree to keep them secret. (note: we have strong reason to believe the “analyses” SmithKline claims are not scientific in any manner, shape, or form-and what SmithKline is claiming is nothing more than a retrospective analysis of computer reports generated by the adverse event reporting system imposed by the FDA. There is nothing wrong with FDA adverse event reporting system, except that-after a drug is one the market—it is a voluntary reporting system for physicians and pharmacists. After an FDA approved drug is distributed into the general population, only a small percentage of adverse events ever get reported. Notwithstanding the limited sample, it is not the limited reporting that is the problem, but SmithKline’s reliance on it for scientific application. SmithKline’s misplaced reliance on the adverse event reporting system to discern addiction/withdrawal is a “garbage in garbage out” technique represented as scientific analysis. This is the same ploy used to justify the drug companies’ refusal to design a forward looking study on the SSRI suicide problem. We believe SmithKline refuses to conduct such studies because they are rightfully dubious of the unsatisfactory results that would ensue from the company’s perspective. As to SmithKline’s “secrecy” requirement, plaintiffs will not agree. That is yet another ploy to keep the public excluded from knowing the hazards of a particular product that is on the market. Plaintiffs will not agree to a secret process without compelling justification. To date, we have not seen anything justifying such secrecy.

Q: What were the symptoms of the 18 Yugoslav patients you claim were suffering “relapse” (and we claim may have been suffering withdrawal)?

A: We object to the question, but we will turn over the case report forms on those patients if you agree to keep them secret. (note: we have refused to agree to secrecy on the forms, but out of respect for the privacy of the patients, we have agreed that SmithKline can delete all identifying data on the patients involved (name, address, etc.) This issue is still unresolved).

Q: Identify by names the physicians who administered the Yugoslav trial.

A: We object, but will turn over the names of all officials authorized to make medical entries on that trial if you agree to secrecy. (note: Here is where pharmaceutical companies conducting clinical trials often skew the results. We do not know SmithKline has cheated, but we cannot presume they have not. As President Reagan once said: “Trust, but verify.” Yes, we must verify. What frequently happens during a clinical trial is that the physician on the scene is perfectly candid, and writes down accurate information. However when this information gets to company headquarters, e.g., a higher up will modify the finding to make the results appear more favorable. Rarely does a “smoking gun” appear to prove out and out cheating, but through massaging data “here” and “there,” statistics can often be molded to portray a much more favorable result than otherwise warranted. It appears in this instance that SmithKline is attempting to keep a lid on the identity of the particular Yugoslav physicians who ran the trials at the clinics. Company executives simply do not leave to chance the details of clinical data collection at the various test sites. We are also naturally skeptical on the Yugoslav venue. With the difficulty of regulatory agencies in the U.S. and U.K. to effectively monitor medical personnel in a country where political instability has been present, the results of such a trial must be viewed with even greater skepticism. We will scrutinize this carefully, and persist until we are confident of how “PAR 08-03” (the Yugoslav trial) was conducted and how the results were tabulated and reported.

Q: (we cited a known source who telephonically called in a withdrawal complaint to SmithKline, and, with the authorization from the patient, asked SmithKline to see all the paperwork that was generated on the patient. We then asked for the identity of the senior SmithKline official who acted on the complaint. Our reason for doing so was our suspicion that SmithKline has been downplaying customer complaints on withdrawal for years. In the next few weeks we will selectively verify known withdrawal complaints to determine if SmithKline was forthright in accepting the patients’ complaints and forwarding the complaints accurately to the FDA.)

A: (SmithKline again objected, but said they would provide the package they prepared on the complaining patient. Large entities, government or private, often have low level people sign reports, even though senior officials review the reports and effectively make the decision on disposition (i.e. the concept of “plausible denial”). In this interrogatory, SmithKline said their “clinical safety physician” regularly reviews adverse reports. This is a typically evasive answer, offering generalities but avoiding the requested specifics.

Q: (we asked whether SmithKline “systematically assessed” the withdrawal issue in the Yugoslav trial?

A: (Interestingly, SmithKline admitted they did not systematically assess withdrawal in the Yugoslav trial. We actually knew that they had not. However plaintiffs maintain SmithKline misrepresented that issue during the FDA’s committee hearing on October 5, 1992. The misrepresentation occurred just before committee members voted on Paxil’s market approval. Page 98 of the committee’s transcript recorded the FDA representative, David Wheadon, MD, saying “As you can see here, few numbers of patients experienced any adverse event after being randomized off(Paxil)into the placebo group and the percentages are certainly very small. But these were the common adverse events seen in that small population IN OUR ATTEMPT TO SYSTEMATICALLY ASSESS A DISCONTINUATION SYNDROME.” ) (Note: As one learns, no SmithKline person publicly utters the word “withdrawal.” Company spokespeople order SmithKline employees to say “discontinuation.” This is quite silly, but propagandists always operate with rigidity of the spoken and written word. In any event, it is readily discernible that exaggeration and stretching of the truth transpires to get a drug approved before FDA committees. The above quote is manifestly clear that SmithKline conveyed the idea they “systematically” assessed withdrawal in the Yugoslav study. They subsequently got caught in a false representation, and now are attempting to recast their deception. We did note their word “attempt” in the above quote-so, to be technically and rhetorically fair, we further asked SmithKline if they “attempted” to systematically study the withdrawal issue, but somehow failed in their objective. We felt we knew the answer to that question, but wanted to hear it from SmithKline nonetheless. The answer was “no” to both. Despite being forced to acknowledge there was nothing “systematic” at all about their withdrawal inquiry, SmithKline continues to be evasive on the issue).

Q: In Paxil’s labeling, why did you warn patients that those with a “history of drug abuse” should worry about tolerance for the drug when other patients were not so warned?

A: We object to the definition of “history of drug abuse” and weren’t responsible for the warning anyway, but we’ll produce paperwork showing the background of the labeling process if you agree to secrecy. (note: here’s another case where SmithKline is trying to evade their responsibility. Plaintiffs are aware that certain “class” warnings were developed for SSRI’s as a class of drug. This phrase (“history of drug abuse”) was one of them, and SmithKline simply adopted it. The problem, however, is that the warning is very deceptive in the case of Paxil. The wording implies that regular patients do not have to worry about developing tolerance of Paxil; only patients with a “history of drug abuse” do. SmithKline is trying to hide behind the FDA’s class warning while at the same time they are aware that Paxil has a 24 hour half life and is much worse on that front than the other SSRI’s. Interestingly, SmithKline did admit in discovery that they have no scientific basis to claim that those with a “history of drug abuse” are at a greater risk to suffer withdrawal (or as they say “discontinuation syndrome”) than other patients.

We have demanded that SmithKline produce the following documents for plaintiffs’ review: (a) documents on withdrawal sent to SmithKline from the FDA; (b) documents on withdrawal sent to the FDA from SmithKline; (c) document establishing the rules for the Yugoslav clinical trial; (d) documents on the 18 patients who suffered “relapse” during the Yugoslav clinical trial; (e) documents explaining the FDA imposed “post marketing” label for Paxil that ordered SmithKline to print on the label: “There have been spontaneous reports that abrupt discontinuation may lead to symptoms such as dizziness, sensory disturbances, agitation or anxiety, nausea and sweating: these events are generally self-limiting.” (f) documents addressing any medical author’s writings on the possible relationship between Paxil and withdrawal; (g) documents that came into your possession depicting new information on Paxil withdrawal that you were not previously aware of;

Document response: In virtually every document request, SmithKline has conditioned their willingness to turn over the documents on the issuance of a “protective order.” As stated, plaintiffs will not agree to secrecy.

All of the above discovery disputes are being worked as this sitrep is written. It is very likely that the judge will have to resolve most of them

Saturday, March 24, 2007

PAXIL STUDY 329 - The Documents

These documents have been made available here through the work of Healthy Skepticism. To visit Health Skepticism please go here


Documents from study 329

DRAFTS/PEER REVIEWS
Draft ?II with ?Keller’s annotations. 11 Feb, 1999.
Draft III. 22 Mar, 1999.
Draft submitted to JAMA, 30 July 1999.
JAMA Reviews, Oct 22, 1999
Response to JAMA reviews, 10 Dec, 1999.

POSTERS
Keller M et al. American Psychiatric Association, Toronto, 2 Jun, 1998
Wagner K et al. NCDEU. Boca Raton, Florida. 11 Jun, 1998.
Berard R, Ryan N. European College of Neuropsychopharmacology, Paris, Oct 1998.
Gagiono C. World Congress of Psychiatry, Hamburg, Oct, 1999.

LETTERS/ MEMOS/EMAILS/MINUTES
Minutes:Teleconference.Paroxetine Study 329 Efficacy Analysis. 22 Apr, 1997
Top Line Results 21 Jan, 1998
Oakes to McCafferty 5 Mar, 1999
McCafferty to Laden 9 Mar, 1999
Katz to Kline, 18 May, 1999
McCafferty to Laden, 19 Jul, 1999
McCafferty to Laden, 21 Jul, 1999
Dulcan to Keller 27 Jul, 2000
White to Hood, 5 Mar, 2001
Battin to Laden, 27 Apr, 2001
Hawkins to all sales representatives selling Paxil, Aug 16, 2001
Ryan to Keller and Strober, 4 Feb, 2004
Keller to Carpenter et al, 14 May, 2004
Keller to Ryan et al, 13 Jun, 2004

DEPOSITIONS
McCafferty Deposition, 24-26 Aug, 2006
Ryan Deposition, 5 Oct, 2006
Oakes Deposition, 7 Nov, 2006

MEDICAL QUERIES/DEAR HEALTH CARE PROFESSIONAL LETTERS
SKB Med Query. Jul, 1998
SKB Med Query. Jul, 1999
GSK Med Query. Jan, 2000
GSK Med Query. Sep, 2001
Dear Health Care Professional. Jul, 2003
Dear Health Care Professional. May, 2004

INFORMATION FOR SALES REPRESENTATIVES
SmithKline Beecham. Nulli Secundus. 8 Dec, 1999
GlaxoSmithKline. GSK Sales Connection. 10 Sep, 2003

OTHER
Proposal: 'Adolescent Unipolar Major Depression: Multisite Psychopharmacology Study' Dec, 1992
Position piece on the phase III clinical studies, 14 Oct, 1998
STI Release Form for JAACAP paper, 3 Nov, 2000
FDA Clinical Review, 2002
Statement of David Wheadon Sep 9, 2004


Now read the statement from GSK after the recent Panorama programme which highlighted much of what the above documents refer to:

This statement was made in 2007 - These people ARE STILL denying they knew despite the evidence I have just provided. How DO they get away with it?

'GSK utterly rejects any suggestion that it has improperly withheld drug trial information,' announced the company in a release issued last night. 'Results from its paediatrics studies were documented and submitted to regulators in accordance with regulatory requirements. Results were also presented publicly, published in scientific journals and are available on GSK's website.'

GlaxosmithREDface

From the makers of the wonderful antidepressant, Seroxat, Glaxosmithkline give you.... well, not exactly what it say's on the bottle


A high school science experiment by two 14-year-old girls has embarrassed the world's second-largest food and pharmaceutical company, Glaxosmithkline.

GlaxoSmithKline will appear in Auckland District Court on Tuesday to face charges alleging 15 breaches of the Fair Trading Act.

The charges, brought by the Commerce Commission, arose from an investigation by Pakuranga College students Anna Devathasan and Jenny Suo into the vitamin C levels of the popular Ribena drink, which has sales of about $8 million a year.

The company faces a maximum fine of $200,000 on each charge.

GSK has a worldwide turnover of more than $61 billion, second only to drug giant Pfizer.

The students - now 17 - decided in mid-2004 to test the vitamin C levels of their favourite juices, including Ribena, Just Juice and Arano, for a school project.

They calculated that each 100ml of Ribena contained about 22mg of vitamin C.

Just Juice products contained levels of about 72mg.

The figure for Ribena seemed too low, particularly as the company had promoted the product by claiming that blackcurrants had four times the vitamin C of oranges.

"We thought we were doing it wrong, we thought we must have made a mistake," Anna said.

The girls got short shrift when they took their observations to GlaxoSmithKline.

In a letter, the girls described its advertising as "intentionally misleading and quite inappropriate".

When they got no response, they telephoned the company.

"They didn't even really answer our questions. They just said it's the blackcurrants that have it, then they hung up," Jenny said.

Undeterred, the girls contacted the Advertising Standards Authority, and Brandpower, but still got no satisfaction.

But then the television consumer affairs show Fair Go picked up the story and suggested the girls take their findings to the Commerce Commission.

The pair put the matter out of their minds, until the prosecution made the news about a month ago. "It's completely unbelievable," Jenny told the Weekend Herald yesterday.

"It's pretty crazy when you realise how much power you can have, as a kid as well." The girls have since visited the company to be thanked "for bringing it to our attention".

GSK's TV advertisements claimed "the blackcurrants in Ribena have four times the vitamin C of oranges".

The commission said that although blackcurrants had more vitamin C than oranges, the same was not true of Ribena.

It also alleged its testing found ready-to-drink Ribena contained no detectable level of vitamin C.

The girls' discoveries have also scored a hit in Australia.

GSK Australia this week dobbed itself into the Australian equivalent of the Commerce Commission, admitting it had been misleading in its Ribena claims.

The case

* Testing found ready-to-drink Ribena contains no detectable vitamin C.

* The Commerce Commission said television advertising claims about the amount of vitamin C in Ribena were misleading.

Hmmm - Wonder what spin they threw on this?

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