Outrageous behaviour today by the MHRA

I have just been given some genuinely shocking news by Bob Fiddaman.

Recently Bob made a Freedom of Information Act request to the MHRA in relaton to some specific questions about Serotonin.

His questions were as follows:

1. Did GSK provide the MHRA background documents giving details about the imbalance of serotonin in the brain?
Please answer Yes or No

2. Did GSK provide the MHRA documents with figures for the effect the drug had in changing the imbalanced state?
Please answer Yes or No

3. Please forward me documents that GSK supplied the MHRA during the application procedure for Seroxat that relate to the ‘correcting effect’ regarding people with lower levels of serotonin.

Interesting questions, I’m sure you agree. Would you like to know the answers?

So would I. Bob knows what the MHRA said but he can’t tell me. Or you.

Because at the bottom of the letter from the MHRA there was a new paragraph (which I have never seen before in two years of my own FOI requests to the MHRA).

“Copyright notice
The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder.”

I’ll have to return to this subject at a later date, because at the moment I am lost for words – this is outrageous.


Glaxo’s ‘response’ to Panorama

So how have Glaxo responded to the BBC – with a writ for libel from their highly paid lawyers? With reasoned argument, brimming with fact, science and trial data? With an apology for the untold harm they have been responsible for? With their reknowned spokesman, Alastair Benbow?

The answer is none of the above.

But what Glaxo has done is to tell us what good guys they are are by putting out a couple of press releases: ‘Glaxo investing $2 billion to expand flu vaccine manufacturing’ and ‘Glaxo building new Dungarvan facility’

“What can we do? We can’t sue them… hang on, we’ll tell everyone we’re creating lots of jobs and we’ll save them all from that nasty bird flu. Let’s try and look like the good guys and maybe Seroxat will go away”.

Glaxo has threatened to sue the BBC but this is a vacuous threat – the simple fact is they cannot sue. The evidence is clear cut in the emails we were never supposed to see and in the words of Doctors Ryan & Keller.

The House of Commons and Glaxo

The Glaxo furore moves into the House of Commons today, as Paul Flynn MP lays down four (yes four) very strongly worded early day motions – will your MP sign?

Your MPs represent you – if you want them to sign make sure they know your feelings…

EDM 769

Flynn, Paul That this House congratulates the previous New York Attorney General, Eliot Spitzer, on his successful law suit which claimed that GlaxoSmithKline (GSK) suppressed four studies that failed to demonstrate that the drug Seroxat was effective in treating children and adolescents and indicated an increase of suicidal thinking and acts; is alarmed by the publication of a leaked GSK document proving they intended to manage the dissemination of data in order to minimise any potential negative commercial impact; and urges GSK to show remorse and to resolve in future to put their customers’ health before GSK profits.

EDM 768

Flynn, Paul That this House challenges GlaxoSmithKline (GSK) to act on its vacuous threat to sue the BBC on its evidence that GSK had deliberately suppressed and distorted trial results of the anti-depressant Seroxat to conceal its direct links to suicide in teenagers; notes that GSK’s own unpublished studies showed the drug actually trebles the risk of suicidal thoughts and behaviour in depressed children without any proven benefit over placebos; urges the Medicine and Healthcare Products Regulatory Agency to accelerate its criminal investigation into GSK begun three years ago; and looks forward to an early prosecution of a company that no longer deserves public trust.

EDM 767

Flynn, Paul That this House questions the propriety and courtesy of the action of GlaxoSmithKline (GSK) in writing to hon. Members with constituency interests in GSK urging them to oppose Motions for Early Day (EDMs) critical of their conduct, then denying originators of the EDMs details of the content of their messages when requested.

EDM 766

Flynn, Paul That this House notes the collapsing confidence in trials of medicinal drugs by pharmaceutical companies; is alarmed at the mounting evidence that such companies’ trials are overwhelmingly biased in their conclusions compared with independent trials concealing adverse effects that have killed tens of thousands of patients; recalls that Sir Iain Chalmers’ evidence to the Health Select Committee that one anti-arrhythmic drug in the 1980s killed more people than all the Americans killed in the Vietnam war in spite of evidence of its fatal consequences that was suppressed for 13 years; recalls that the Safety Director of the US Food and Drug Administration said that the painkiller Vioxx caused up to 140,000 strokes and heart attacks in the USA alone; notes claims that Merck suppressed information on Vioxx’s dangers in the same way that GlaxoSmithKline denied access to evidence of adverse reactions to Seroxat; and calls for the establishment of an independent drugs testing agency funded by a levy on pharmaceutical companies modelled on the Italian Agenzia Italiana del Farmaco.

You can find a link to Paul Flynn’s website just to the right, in my Blogroll.

The good Dr Keller

I hope that you all remember Dr Martin Keller – we were introduced to him in this week’s Panorama – Secrets of the Drug Trials.

Dr Keller is a KOL – a key opinion leader. He is also chair of psychiatry at Brown University in America. According to his curriculum vita, he has over 300 scientific publications. People take his opinions seriously. He is a serious KOL or thought leader in academia and sought by the drug industry.

A seriously expensive KOL if you want to ‘buy’ his key opinion leadership for your drug…

You really must read ‘Drug companies enrich Brown professor’ to appreciate just how much (and for how long) Keller has been favoured by the drug companies. This is an old article, which details Keller’s ‘consulting fees’ from the late 1990’s.

There’s even more to read here about the good Doctor.

The ongoing saga of Lisa Blakemore Brown

I have already made a post about the victimization of Lisa Blakemore Brown by the British Psychological Society – but this case seems to get more and more stange by the day.

This link will take you to correspondence between Dr Aubrey Blumsohn and the British Psychological Society, you will see Dr Blumsohn asking to attend Lisa’s latest hearing – and Lisa herself saying that she has no objections at all to him being there… why then has Dr Blumsohn (and several other concerned doctors and colleagues) been banned from the hearing by the British Psychological Society?

Not only has Aubrey Blumsohn been banned – but the Chair of the hearing has not authorised anyone to give him a reason why.

This one just gets better and better.

What have the British Psychological Society got to hide?

Social Audit, Panorama, Glaxo and the MHRA

The inimitable Charles Medawar weighs in with his commentary on last night’s Panorama programme. He writes:

“Panorama (BBC-TV) last night broadcast its fourth programme on Seroxat® (paroxetine), a still deeper foray into the built-in nastiness of drug marketing and product promotion. All credit to the programme for sticking with the issue, if only to reveal how much more must be done to see this story through.

Thanks largely to Panorama and friends we now have a pretty clear picture of motive, opportunity, method and the sometimes awful consequences. Corrupting influence in pharmaceutical science has become almost natural and easy – the product not only of greed and self-interest, but of established professional and organisational practice. In some ways, collective lack of commitment and imagination seem to trump venality. Indifference rules, OK?

The more this story unfolds, the more scary seems the inter-dependence and over-connectedness of the three main powers. Between them, the Pharmas and their agents, governments and regulators, and doctors and research workers have constructed a ‘health-care’ system that now seems, almost routinely, to put health second and them on top.”

To see where we go from here please visit the Social Audit website and read the full article.

Glaxo back in the frame

Alex Brummer, the City Editor of the Daily Mail has written a short, to the point piece, which you can read in full here.

He finishes his article like this:

“Now we are told that the MHRA began a criminal investigation into GSK and Seroxat three years ago. It seems astonishing that this investigation has not been brought to a conclusion given that so many of the documents are in the public domain following the Spitzer settlement.

The families of Seroxat victims would be entitled to wonder why the MHRA is more interested in protecting drug giants than the consumer.”

That’s the question isn’t it – why has the MHRA let the public down?

Responses to Panorama – on the BBC website

There are quite a few responses to Panorama on the BBC website so far and a lot of them tell terrible stories.

Feel free to add your comments on the link above.

Want to see some of the documents that Glaxo don’t want you to see?

If you’d like to see some of the documents that Panorama mentioned tonight, then I suggest you look here.

Panorama & Seroxat – 29 Jan 2007

I’ve just spent half an hour watching Secrets of the Drug Trials – the latest Panorama investigation into Seroxat (Paxil).

My first thoughts are that because these emails are no longer secret it’s great that the public can see how drug companies operate – how cleverly they market their products. Profits come before patients for them – Glaxo cares nothing for the people who have been harmed by Seroxat.

I was interested to see what kind of people Doctors Ryan and Keller were – they had become lazy and greedy and totally disinterested in anything approaching patient welfare. They believe in their own hype – they really think they’re Masters Of The Universe. But in reality we now know their reputations have been sold and bought many times over by Big Pharma.

The contrast between their smug, flippant uncaring attitude and the powerful story of Stephanie Gatchell, whose daughter killed herself while taking Seroxat, could not have been better made. Forget sales figures, share price, profits and dividends – this is about people’s lives.

But perhaps the most surprising thing was the lack of a meaningful response from Glaxo. I couldn’t work out if it the company was too scared to put someone up to appear on camera, knowing the strength of this new evidence against it; or whether it just couldn’t be bothered.

Maybe the all powerful Glaxo sees this as just another bump in the road on the way to its next billion.

And for those of you who wait for the outcome of the criminal investigation of Glaxo in the UK being undertaken by the MHRA, I would advise that you don’t hold your breath…

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