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Researching drug company and regulatory malfeasance for over 16 years
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Tuesday, December 18, 2007

GlaxoSmithKline – Big pharma, big risks

Source: Ethical Corporation



Some fantastic bullshit quotes from GSK here. I've added my own comments in blue after each paragraph.

Fid



GlaxoSmithKline – Big pharma, big risks



Drug firms are opening up to address public distrust, says GlaxoSmithKline’s head of corporate communications (1)

Excuse me! Did I read that correctly? Drug firms are opening up? Opening up surely means they've been shut doesn't it? What's this, GlaxoSmithKline admitting that they have been less than transparent? Surely not!



For drug maker GlaxoSmithKline, 2007 has been a year of severe ill health followed by mild recovery. The firm’s share price crashed to a two-year low in May after its second biggest selling drug, diabetes treatment Avandia, was linked to increased risks of heart attacks. Since the scare, sales of the drug have slumped 50 per cent in the US and 40 per cent worldwide. Avandia last year racked up sales of £1.6 billion. (2)

2007 a year of severe health because more and more resources are available. JP Garnier must rue the day the internet was invented. All praise Bill Gates.

Nice to see GSK hit where it hurts (in the pocket) - £1.6 billion for Avandia sales. GSK Accounts Dept must have had such a wonderful time counting the pennies, hope they washed the blood off their hands after!



There was better news for GSK last month when the US Food and Drug Administration ruled, as expected, that the company must slap a “black box” warning on the drug, but did not ban it. The decision backed up GSK’s claim that the original study linking Avandia to a 43 per cent increase in risk of heart attacks was misleading. But another study, published in September, supported these findings. GSK maintains that “meta-analysis”, looking at a large body of historical clinical data, has found no clear evidence of a link. (3)

The FDA should be utterly ashamed of themselves. Even with a 50% drop in sales Avandia could still earn GSK £800M - Who fund the FDA ladies & gentlemen? Pharma that's who! No conflict of interest with the FDA's descision then huh?

Look at paragraph (1) again then the bottom of paragraph (3) - You see people - GSK are already shutting its doors after stating in the opening paragraph that they would be opening them! Avandia causes heart attacks, it's been proven but GSK want to have the last say on the matter, probably to protect the 50% of sales that haven't yet been affected by Avandiagate.

Let me spell it out for GSK - THERE IS A HIGH RISK OF HEART ATTACKS IF YOU TAKE AVANDIA



GSK’s losses over Avandia show the high stakes that research-based pharmaceutical firms take on when developing drugs. Vice-president for corporate communications Duncan Learmouth admits this is hard to explain to the public, saying: “We feel like we are shouting in a storm.” His concern is that big pharma is too often associated with big risks, such as health scares. “There’s a danger in the media overplaying the risk side without balancing it with the benefit, and oversimplifying what is a very complicated situation of giving a drug to someone,” he says. (4)

Oh look at Duncan Learmouth patronising the public. 'Hard to explain to the public'? What is hard about it? Are GSK some form of extra terrestrial intelligence that us mere mortals (public) are not yet ready for? Mr Learmouth, you are a pious pillock. You don't give the public the credit they richly deserve. Isn't it members of the public that are giving your employers such a hard time right now?

Learmouth doesn't stop at the public, he even has a go at the press for overplaying the risk side without balancing the benefit. Tell you what Mr Learmouth, lets say we get together, just the two of us, we can play russian roulette - one bullet, six chambers - you up for it - hey the benefits far outweigh the risks doncha think? Failing that we could always find a member of your family or a close friend who has diabetes. Maybe you would like to offer them Avandia? Hey, the benefits far outweigh the risks wouldn't you say?



Despite concerns about how product risks will be interpreted by the public, Learmouth expects pharma to become ever more transparent. Two years ago GSK decided to publish data on clinical trials online, although he admits the register could be more user-friendly. The decision came after damaging claims that it had concealed clinical trial results from the general public in the case of anti-depressant Seroxat. (5)

Is Learmouth taking the piss here? Ever more transparent? When have GSK EVER been transparent? They even lied about the Vitamin C content in their Ribena for fucksake! And what about the Paxil 329 study - how was that being transparent? They might argue that they have learned from their mistakes - thing is... they have NEVER admitted to their mistakes. Maybe then the 'public' may take them seriously when they tell us that they are going to be transparent. Do they even know the meaning of the fucking word? Maybe they have the same guidelines as the MHRA when it comes to transparency because they are about as transparent as a scene from a Hammer Horror film featuring Jack the Ripper on the streets of London!



The firm denies that it “improperly” withheld data from Seroxat clinical trials of the 1990s and says that it filed all information with regulators. Learmouth says it is wrong to judge the case by today’s standards of corporate transparency: “Before it was not that there was some conspiracy to hide this information, it was just never done.” (6)

Oh puhlease, you are beginning to sound like that other GSK mouthpiece, Ali Benbow. YOU DID NOT.... I REPEAT... YOU DID NOT file ALL information with the regulators. PAXIL STUDY 329 Mr Learmouth. Your company has settled out of court on numerous occasions regarding your defective product, admittedly, your team of lawyers have persuaded the prosecution to accept gagging orders. Clever... so clever. There will come a day where GSK stumble across some stubborn individual who will not bow down to the money you wave at them. There is no conspiracy - there is only fact!



Similarly, GSK has “recognised the need for much stronger policies” on using ghostwriters in preparing end of trial papers, says Learmouth. He admits that the old practice of using PR agencies to write papers today “does not really pass the smell test”. These days a report’s lead author, a physician, must have written the most significant part of a paper. GSK employees and other outsiders involved must also be named in the paper, and their affiliation noted. (7)

The smell test? HAHAHA now there's a new one from GSK. What is a smell test? The smell test failed when you hired Martin Keller to write his bollocks about the safety of Paxil - did he write it? The only smell coming from that particular test was bullshit Mr Learmouth. Would you be making such comments if Keller had been allowed to get away with it? I doubt it.



An area where GSK is improving its reputation is expanding access to medicines for patients in developing countries. The firm has a malaria vaccine that is about to go into the final phase of clinical trial, which has been part funded by the Gates Foundation. If all goes to plan, the vaccine could hit the market by 2010, says Learmouth. (8)

Developing countries huh? Would these be the same developing countries GSK charged excessive prices for Aids drugs to the detriment of South Africans with HIV/Aids and in violation of the Competition Act? Didn't GSK drop their legal effort to prevent South Africa from importing cheaper anti-AIDS drugs and other medicines?

Don't throw the developing countries line at us Mr Learmouth. We know from your history how you treat developing countries. This IS NOT about helping the ill, it's about making money so please cut the crap!



Next year should see GSK launch a combination vaccine, Globorix, for illnesses that mainly kill children in Africa such as diphtheria, tetanus and whooping cough. The company has spent $400 million developing the drug, despite expecting little return on this investment. Globorix will be a tiered-priced product, meaning its price will vary depending on governments’ ability to pay. (9)

And how big is GSK's gun going to be when they ask each indivdual government? They remind me of Spielberg's character Indianna Jones, you all know the scene, he takes a sip of his cocktail only to find out that it is poison - he is however given hope, the villain has the antedote and is prepared to give it to Indianna Jones.... for a rather huge diamond. How big does the diamond have to be for GSK before they give this new combination vaccine to some poor African child?



The company’s efforts to improve access to medicines have won two cheers of support from Oxfam. Policy adviser Helena Vines Fiestas says of the company’s work on access: “GSK is probably the leading company within the sector. But it still falls far short of a desirable position.” She welcomes GSK’s current work on developing 11 new drugs predominantly aimed at patients in poor countries, saying: “This number is high for the industry.” (10)

Oxfam are a charity - who on earth are they to pass comment on how 'wonderful' GSK are? Wait am minute... Do they recieve funding from GSK? I wonder if Helena Vines from Oxfam knows about the following GSK misdameanours? HERE



Critics have sounded the death knell for big pharma because of the lack of new drugs in their research pipelines. Learmouth disagrees. “Because the risk is high and probability is low, chance plays a big part in whether a company can discover a new class of drugs,” he says. “You have to be a certain size to play the odds of that.” (11)

'Risk is high and probabilty low' - maybe you should stick that on Seroxat patient information leaflets!



Despite its recent travails, GSK has the resources to keep playing those odds – for the potential benefit of patients in developed and developing markets alike. (12)

Hmmm, I beg to differ. People have had enough of the lies. The stench eminating from within GSK is overpowering so much so that it can even be smelled outside the offices of the FDA in America and the MHRA in England!

Rant over

Fid

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