Zantac Lawsuit

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

Wednesday, October 31, 2007

GSK axe begins to fall

By Anna Lewcock
Source: In Pharma

26/10/2007 - GlaxoSmithKline (GSK) has been swift in implementing its plant cuts, already announcing the first sites to be axed mere hours after revealing its restructuring plans.

GSK unveiled it so-called 'Operational Excellence' programme on Wednesday, cutting sites and streamlining operations to combat falling profits, and by the end of the day had announced that its troubled Cidra, Puerto Rico, plant would be the first to fall to its axe, with news on a number of UK plants fast on its heels.

While GSK has been reluctant to put a number on how many plants or jobs will be lost, and refused to confirm speculation in the UK media that there could be as many as 5,000 job cuts, exchanges between GSK employees on an online blog seem to suggest that sales and marketing could be trimmed by around 1,000 positions.


Fiddy Rant:

Its always a sad day when a man is stripped of his dignity and told he is no longer required for by his employer. It is tragic also for his family that he will no longer be providing them with the lifestyle they have become accustomed to. His children will suffer through peer pressure at schools, his wife may not be able to afford those expensive trips to have her nails done once a month. He himself may have to now tighten the purse strings and forfeit his beloved pastime. He will no doubt fall into a pit of deep despair if he can't find work again - this will have a knock on effect with his wife and kids and the marriage may become strained, may even become so frustrating that he may fall into depression.

How ironic would it be if an axed member of GlaxoSmithKline was forced to take a drop of his former employers medicine?

The first paragraph pretty much sums up what many Seroxat sufferers have had to endure during their time on and off the 'wonder drug'.

Many have lost their jobs along with their dignity. Many have seen their marriages become a sham because of the lack of understanding by the watching partner who cannot quite understand the violent mood changes in her husband. Many children have watched as their once proud, happy go lucky dad has changed into a moody volatile monster. Many sufferers of this drug thought their nightmare was over once weaning off it. But they didn't forsee the long term effects of taking Seroxat, the sleepless nights, the short term memory loss, the akathesia.

GSK axe jobs. Big fuckin deal!

Friday, October 26, 2007

Glaxo cuts jobs to save £700m a year after profits slide

Glaxo cuts jobs to save £700m a year after profits slide

· US sales of top selling diabetes drug down 50%
· Tougher regulation and generics hurt entire sector

Marianne Barriaux
Thursday October 25, 2007


GlaxoSmithKline yesterday unveiled a cost-cutting programme that will involve job losses and the closure of manufacturing sites, as it reported third-quarter profits were hit by declining sales of its troubled diabetes treatment, Avandia.

The world's second-largest drugs company said the restructuring programme would deliver annual pre-tax cost savings of up to £700m by 2010 but would need £1.5bn to implement.

Chief executive Jean-Pierre Garnier declined to say how many jobs were likely to go but 40% of the savings will be made in manufacturing, 40% in sales and the rest in research and development. Analysts said they expected the job losses to run into thousands.

Unions were quick to condemn the move. Linda McCulloch, Unite national officer for the pharmaceutical industry, said: "This is a profitable company that does not need to cut jobs or close plants and we will fight any attempt by the company to do either in the UK."

But Mr Garnier said the programme was crucial for GSK to adapt to a changing environment. It is the latest drug maker to announce cost-cutting measures in the face of growing competition from cheaper generic medicines and a tougher safety stance by drug regulators.

Pfizer, the world's leading pharmaceuticals group, announced this year that 10,000 positions will be axed worldwide, and AstraZeneca, the UK's second-biggest drug firm, is to cut 7,600 posts.

Mr Garnier said: "We have always had pricing and reimbursement issues - that's not new. What is new is that the regulatory authorities, particularly and primarily the FDA, have slowed down their pace of approval of new products. It's just taking a longer period of time to approve new products. In our business model, we need to replace products that go off patent quickly, so we can't have those delays. They're making our lives a little more difficult."

News of the cuts came as GSK reported a 2% drop in third-quarter pre-tax profit to £1.9bn at constant exchange rates, on sales 1% ahead at £5.5bn.

GSK said savings from the cost-cutting moves will amount to around £350m next year and will partly offset the impact on earnings from generic competition and lower Avandia sales.

The company has been hit hard by the safety scare surrounding Avandia, one of its best-selling drugs. In May, a study published in the New England Journal of Medicine linked the treatment to an increase in heart attacks, and prescriptions have fallen by more than 50% in the US since the week before the report was published. The company said total sales of Avandia and its related products were down 38% to £225m in the third quarter.

"Clearly the loss of part of Avandia, in the US particularly, gives more urgency to the need to adjust to the external environment," Mr Garnier said. "You can always have an Avandia day. It's a sad day but it happens and you have to be ready."

He added the group remained on track to meet its earnings guideline for the year - earnings per share growth of 8 to 10% at constant exchange rates .

The company said it would continue to look for outsourcing opportunities, although Mr Garnier ruled out outsourcing the group's entire production capability.

In R&D, it would increase investment in biopharmaceuticals, vaccines and emerging markets such as China.

GSK said its new drugs pipeline remained solid, with 149 projects in clinical development, including 33 products in phase-three development or registration. It has had 15 drugs launched, approved or filed so far this year.

The company announced this month that Andrew Witty, the Europe chief, would replace Mr Garnier when he retires next May. But Mr Garnier refused to be drawn on whether the two other candidates - David Stout and Chris Viehbacher - would remain with the company.

"When I was at their level in the company, I got lots of CEO offers," he said. "But I didn't take them. I waited for the right one to come along, which was my own company. Of course, the phone has been ringing even before - they're not exactly unknown within the industry - so I don't think anything has changed."

Shares in the group closed down 11p at £12.49.

Wednesday, October 17, 2007

Memo to Andrew 'Not so' Witty

1. Sort the Paxil/Seroxat debacle out.

2. Terminate the employment of Alistair Benbow

3. Look up the word 'Conscience' in a dictionary

Oh and puhleeassse change the GSK promise 'DO MORE, FEEL BETTER, LIVE LONGER', it's soooooo patronising!

Your ever good friend

Robert 'Fiddy' Fiddaman

Tuesday, October 16, 2007

More coverage for yours truly... :-)

Seroxat - The Main Culprits OpEdNews, PA - 2 Oct 2007It is my belief that they have known about the dangers of Seroxat in both adults and children for some considerable time, yet both have robustly denied any ...

A Chemical Imbalance - The Serotonin Myth OpEdNews, PA - 30 Sep 2007Was it invented purely to market GSK's baby, Seroxat? But more importantly, did GSK know that patients would become addicted to it, thus earning them ...

MARKET THE DRUG... THEN MANUFACTURE THE DISEASE OpEdNews, PA - 24 Sep 2007It suggested that people with common phobias could be persuaded to take Seroxat. It raised concerns with Mental Health campaigners about how Pharmaceutical ...

Sunday, October 14, 2007

The Dawning of a New Era - GSK's Andrew Witty

Never has a surname been more inappropriate

Saturday, October 13, 2007

A Trip Down Memory Lane For GSK Part 1

Thanks to the Truthman for sending me some 'interesting' GSK related articles, the first of which delves into clinical trials in Nepal to test an experimental vaccine for Hepatitis E.

GSK is criticised for army drug test
By Andrew Jack in London
Published: February 28 2006 18:16
Source: FT.Com

GlaxoSmithKline, the UK pharmaceutical group, and the Walter Reed Institute, the US army’s medical research body, are facing criticism for clinical trials in Nepal to test an experimental vaccine for Hepatitis E.

Jason Andrews, a researcher at Yale School of Medicine based in Nepal, said they violated international ethical guidelines by using vulnerable subjects, failing to publish rapidly the results and not having a clear plan on how to bring the vaccine to market.

The allegations, raised with the Financial Times and detailed in the latest issue of Perspectives in Biology and Medicine, a US academic journal, will reopen the debate over the international system governing clinical trials. It also highlights the difficulties facing researchers attempting to develop drugs and vaccines for the developing world, where the commercial incentives are limited.

GSK and Walter Reed began co-operating in 1998 on the development of a vaccine for Hepatitis E, an infection under study since the 1980s and estimated to affect 1 per cent of India’s adult population. About 1 per cent of those with the disease die as a result.

After considering holding trials in Thailand and then among villagers in Nepal, local controversy over the motives and benefits of the research pushed the scientists to shift testing to Nepalese soldiers, beginning in 2001. The findings showed 96 per cent efficacy after three doses, with no significant side effects.

Even before launching the trials, GSK said it had decided the vaccine did not have a commercial application for travellers, while Walter Reed decided it was unsuitable for its soldiers.

However, the partners went ahead with the trials, which Mr Andrews said violated the ethical principle that a commitment should already have been made to develop the vaccine for local use if it were a success.

He accused the trial researchers of undue delay in seeking support for development of the vaccine by only publicly presenting their findings almost two years after the results were finalised in January 2004.

He said the use of soldiers as volunteers was questionable under ethical research guidelines because they could easily be coerced into taking part.

However, Bruce Innis, who co-ordinated GSK’s efforts and used to work at Walter Reed, said: “It’s easy to take pot shots. The real world is very complex. The flip side is that if we didn’t do [something], that could also be unethical.”

He pledged that GSK would strive to find a sponsor to help develop the vaccine, potentially working in India or China. “It’s not our philosophy to leave something good like this on the shelf,” he said.

But he said Hepatitis E was not judged to be a major killer disease in the developing world, which had meant so far it had not identified a partner.

He said “a lot of procedural safeguards” had been put in place in preparing for the trials, and that 5,500 of 12,000 soldiers approached agreed to participate. “People were free to say no.”

Friday, October 05, 2007

Mom files class-action suit

Source: The Province (Canada)
Susan Lazaruk, The ProvincePublished: Friday, October 05, 2007

A Vancouver mother has launched a class-action lawsuit claiming the anti-depressant Paxil caused her daughter's heart defect.

Katie Jane Bennison filed a writ against GlaxoSmithKline, claiming the giant pharmaceutical company failed to warn her of the risk of heart defects in newborns when taken by women in the first trimester of pregnancy.

Her daughter Sophie was born in 2005 with a hole in her heart, which required surgery. Bennison alleges it was caused or contributed to by her use of Paxil during her pregnancy.

The action must be certified before it can go ahead. GlaxoSmithKline, the U.K.-based maker of Paxil, has two weeks to respond to the writ, which claims unspecified damages.

In September 2005, the U.S. Food and Drug Agency issued a warning that detailed the results of a study linking Paxil to birth defects after an increased number of women taking Paxil during the first trimester of pregnancy had babies born with birth defects, including heart problems.

Four Long Years MHRA/GSK Investigation

My good friend over at Seroxat Secrets kinda sums it all up. It's four years this week since the MHRA started their investigation in GlaxoSmithKline. Four years on and people are still being prescribed this drug, indeed children are still being prescribed it off-label too.

What a shambles the MHRA are!

Protect our health? Protect their wealth more like.

Read Story over at Seroxat Secrets HERE

Wednesday, October 03, 2007

Another GSK Funded Study Promoting Seroxat?

Panic attacks can cause heart attacks eh? Don't worry GSK have just the drug to prevent panic attacks. Why else would they fund this latest study?

Panic attacks may hike heart attack risk
Updated Tue. Oct. 2 2007 9:12 AM ET News Staff

Older women who experience panic attacks may have an increased risk of a heart attack or stroke and an increased risk of death in the next five years.

The study, published in the Archives of General Psychiatry, finds that women who had a full-blown panic attack during a six-month period were three times more likely to have a heart attack or stroke over the next five years.

Panic attacks are the sudden development of fear, anxiety or extreme discomfort, and may be accompanied by shortness of breath or chest pains, among other symptoms. They can occur at random or as part of an anxiety disorder, such as social anxiety disorder or phobias.

Dr. Jordan W. Smoller of Massachusetts General Hospital in Boston, led a group who studied 3,369 healthy postmenopausal women (age 51 to 83). When they entered the study between 1997 and 2000, the women filled out a questionnaire about the occurrence of panic attacks in the previous six months.

About 10 per cent of the group, or 330 women, reported a full panic attack during the previous six months.

The women were then followed for an average of 5.3 years to see whether they had a heart attack or stroke or died from any cause. Forty-one of the 3,243 women in the group had a heart attack or death from a heart problem. An additional 40 had strokes.

Among the group that had reported having a panic attack, about four per cent had a heart attack or stroke. That compares with two per cent of the women who reported no panic attacks but who had heart attacks or strokes.

Once the researchers adjusted for other health factors, they found the heart and stroke risk was three times greater among women who had panic attacks.

Previous research has found that panic attacks are more common in women than in men. Smoller speculates that a panic attack may trigger heart rhythm problems. Or, it's possible that stress hormones released during an attack may harm the heart.

The findings add panic attacks to a list of mental health issues -- depression, fear, hostility and anxiety -- linked to heart problems, say the authors.

The study was funded by the drug company that is now GlaxoSmithKline PLC, the maker of Paxil, an anti-anxiety drug. Some of the study's co-authors reported financial ties to that company and others.

Tuesday, October 02, 2007

Findings on drug risk welcomed

Source: The Nelson Mail New Zealand
The Nelson Mail Tuesday, 2 October 2007

The family of a Nelson businessman who committed suicide has welcomed a coroner's recommendation that health professionals fully advise patients and their families of the risks of certain antidepressant drugs.

Nelson coroner Ian Smith has released his findings into the death of real estate agent Peter Michael Noonan, 53.

Mr Noonan was prescribed the selective serotonin re-uptake inhibitor (SSRI) anti-depressant drug Aropax days before his death on July 27 last year.

His wife Gaile Noonan told the Nelson Mail on Tuesday that she hoped Mr Smith's findings would be taken on board by the medical profession.

"We would like to think someone else could be protected from having these things happen."
She said she believed her husband could have concealed information about his condition and medication, to protect her.

"Perhaps caregivers should be there when they go to the doctor."

Mrs Noonan said the family had received an "enormous" amount of ongoing support, but her husband's death had left a big gap in the family's life.

Mr Smith last year began investigating a possible link between SSRIs and the effects on people suffering mental illness, particularly an increase in suicidal thinking and behaviour.

Mr Smith said Mr Noonan was a "respected businessman" but his life began to "go awry" after he decided to change jobs from property valuation to real estate.

He began withdrawing from normal social activities, and concerned family and friends urged him to seek help.

Mr Noonan visited general practitioner Hamish Neill on May 5, 2006 about his anxiety and depression, and was referred to psychotherapist Burke Hunter, whom he saw on May 9.

Mr Noonan saw Mr Hunter seven times, before Mr Hunter left on a six-week overseas trip.
Mr Smith said that while Mr Hunter had suggested the name of another counsellor who could be consulted in his absence, it appeared that no active steps were taken to set up an alternative therapist.

In July, Mr Smith recommended that Medsafe introduce a "black box"-type warning for SSRIs, with information about potential risks. Mr Smith said no information about Mr Noonan's thoughts of suicide or a referral to a psychiatrist was discussed with Mrs Noonan.

"It would appear that neither Mr Noonan nor his family was aware of the possible side effects of this medication."

Mr Smith said he was pleased to see that warning information was now available from Medsafe, but it was important that prescribers disclosed it to patients and caregivers where applicable.

Mr Smith said all people concerned with the care of someone, including family, should understand the process.

"Unfortunately, many doctors still think `Privacy Act - can't disclose', which is not correct," he said.

MHRA FOI Request Answer

A while back I wrote to the MHRA asking whether or not the following list of people were or have been involved in the current investigation into GSK. I asked because ALL those on the list have or have had 'ties' with GSK in the past.

Here is the list.

Professor A Blenkinsopp, Professor H Dargie, Dr M Donaghy, Dr J C Forfar, Dr R Leonard, Prof D J Nutt, Professor J F Smyth, Professor Christopher Bucke, Prof Nicholas Mitchison, Dr Brian J Clark, Professor Robert Booy, Professor S M Cobbe, Professor J E Compston, Dr A Glasier, Dr Andrew A Grace, Dr P Hindmarsh, Professor P D Home, Dr R F A Logan, Professor R MacSween, Professor J O’D McGee, Professor David R Matthews, Dr A Smyth, Professor A D Struthers, Professor J C E Underwood, Dr A Gerard Wilson, Dr Rosemary Leonard, Mr David P S Dickinson, Dr Charlotte C D Williamson, Professor Anthony H Barnett, Professor V Krishna K Chatterjee, Professor Albert, Sir Alistair Breckenridge, Dr Ian Hudson.

...and here is the MHRA's response.

Dear Mr. Fiddaman,

REF: FOI 07/260

Thank you for your enquiry of 29th August.

As you are aware, the MHRA is conducting a detailed criminal investigation into the allegation that Glaxo Smith Kline failed to disclose clinical trial data at an earlier stage. The investigation is still in progress.

The individuals named on your list (apart from Professor Breckenridge and Doctor Hudson who are current Board members) are, in the vast majority, past or present members of MHRA Advisory Bodies or external Advisory Panels. No individual on the list has formed part of the investigation.

Kind Regards,

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

So are they saying no individual on the list has formed part of the investigation apart from Breckenridge and Hudson or when they say no individual do they include these two characters?

I won't bother wasting my time writing them again - I pretty much know the answer already.


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