Zyprexa injunction – breaking news

It seems that someone put the Secret Eli Lilly documents on the internet and Lilly is not happy at all.

See here for the latest developments.

Eli Lilly and Zyprexa – the cat is out of the bag

More on drug marketing and Big Pharma’s approach to patients and profits.

In 1996, Zyprexa was approved for the treatment of adults with schizophrenia, and a few years later, it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.

Yet despite these extremely limited approved uses, Zyprexa went on to become the top selling antipsychotic worldwide with an estimated 20 million people having used the drug and Lilly’s best-selling product, with $4.2 billion in sales in 2005, which translates into 30% of its total revenues.

The problem is, it’s actually not very good for patients’ health (an understatement) and Lilly is keen ($4.2billion a year keen) to stop the world from finding out the truth.

If you want to find out more about Zprexa and the way that Big Pharma operates, perhaps you might begin here.

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A simple enough question – 2

OK – I’ll come clean.

“A simple enough question” (28 Dec 2006) was a trick question – no one really knows what a ‘correct’ level of serotonin is – it is merely a marketing concept. You don’t have to take my word for it, though. I’ll let Professor David Healy explain.

What makes Healy of particular interest is that he’s no maverick, driven by a belief in herbs or the healing power of madness. He is a mainstream biological psychiatrist and director of the North Wales Department of Psychological Medicine in Bangor, he has written a highly acclaimed history of anti-depressants, The Anti-depressant Era, as well as Let Them Eat Prozac – and he is the author of more than 100 scientific papers. But he is concerned that patients and the profession are not being told the truth about the risks.

Nineteen years ago, depression was viewed as a severe mental condition that often required hospitalisation, while anxiety, sadness, worries about social situations and feeling tired all the time were considered milder conditions and treated with tranquillisers such as Valium. With the arrival of SSRIs, tranquillisers fell heavily out of favour because they had been shown to be addictive. In their place were SSRIs – safe, non-addictive and effective. The one psychopharmacological fact everyone became familiar with (thanks to the marketing departments of Big Pharma) was that serotonin is the brain’s feel-good chemical: too little of it and you feel blue, worried, down, depressed. SSRIs increase the amount of serotonin available in the brain.

“The only problem with this story,” Healy told an audience at the Institute of Psychiatry in London in February 2002, “is that there are no studies proving that serotonin levels have anything to do with depression.” He can speak with some authority on this because, before moving to Bangor, he was researching serotonin receptors at the Department of Psychiatry at Addenbrooke’s, Cambridge. “SSRIs can certainly have an effect on mood, and for some people they are very effective. But we don’t really understand how they work, and it is not by directly changing serotonin levels.”

When SSRIs were launched, they were described as anti- depressants to distinguish them from the addictive tranquillisers. But there was a marketing problem. They weren’t actually effective in treating classic depression. What was needed was for them to become the drug of choice for the people previously given tranquillisers. The key to this was the notion that low levels of serotonin were a problem that could be treated as a deficiency disorder, on a par with having low levels of a vitamin or mineral. That old-fashioned benzodiazepines, such as Valium, had dealt with these anxiety disorders by affecting an entirely different brain chemical, known as gamma-aminobutyric acid (GABA), was simply ignored.

I’ll finish with another quote from Professor Healy: “The serotonin theory of depression is comparable to the masturbatory theory of insanity. Both have been depletion theories, both have survived in spite of the evidence, both contain an implicit message as to what people ought to do. In the case of these myths, the key question is whose interests are being served by a widespread promulgation of such views rather than how do we test this theory.”

A simple enough question

By now I think we all know the wonderful fairy tale about the way Seroxat (and all SSRIs) are supposed to work:

“In the brain there are numerous different chemical compounds called neurotransmitters. These act as chemical messengers between the nerve cells. Serotonin is one such neurotransmitter and has various functions that we know of.

When serotonin is released from nerve cells in the brain it acts to lighten mood. When it is reabsorbed into the nerve cells, it no longer has an effect on mood. It is thought that when depression occurs, there may be a decreased amount of serotonin released from nerve cells in the brain.

SSRIs work by preventing serotonin from being reabsorbed back into the nerve cells in the brain. This helps prolong the mood lightening effect of any released serotonin. In this way, paroxetine helps relieve depression, panic and fear.”

So my simple question is this:

Who can tell me what is the correct level of serotonin that I need to have in my brain?

and also perhaps someone could tell me…

…how much is too little serotonin?

…how much is too much serotonin?

…if I take 30mgs of Seroxat for 7 years what will my serotonin level increase to?

Come on Glaxo – you claim to know what Seroxat does, let’s have the detail – now.

(Thanks to Bob Fiddaman for this wonderful piece of logic)

And another site of special interest

I’ve just seen this particular post. It makes for terrible reading and makes a mockery of Dr Alastair Benbow, The Head of European Clinical Psychiatry at the pharmaceutical company GlaxoSmithKline, when he denies claims that Seroxat could be responsible for violence in users, saying there was no “reliable clinical evidence that Seroxat causes violence, aggression or homicide”.

Just scroll down the list and read a few stories then tell me that nothing’s wrong and SSRIs are ‘safe’.

Why won’t Glaxo do any reasearch into the possibility that Seroxat can cause violence, aggression, suicide or homicide and that some people (35% and rising) have terrible problems withdrawing from the drug?

Maybe they already know the truth.

If you want to have a look at just how unconvincing Benbow really is then go here and watch the video.

I’m not the only one

From time to time I intend to feature sites of Special Blogging Interest (SBIs), and I’d like to give a special Xmas mention to these sites:

Dr Aubrey Blumsohn is a respected UK research scientist working at Sheffield University… or at least he was until Proctor & Gamble ‘lent’ on his employers. It’s a worrying story that shows the amount of influence Pharmaceutical companies have as well as the way they operate. Whistleblowers like Dr Blumsohn are very brave people.

Site number 2 today is close to my heart. Clearly I’m not the only one who has issues with the MHRA.

Last but not least today, please take a look at the new AHRP blog. Bookmark this one for fast moving breaking news and commentary.

Dr Ian Hudson

While I’m thinking about the MHRA, here’s something else I want to share with you. The MHRA is not funded by the taxpayers of the UK – rather, it is entirely funded by the Pharmaceutical industry – it takes fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income.

The links between industry and the MHRA are very, very close.

Dr Ian Hudson is the MHRA’s Director of Licensing – but the job he had before he joined the agency was at GlaxoSmithKline – he was their Worldwide Director of Safety, and we know that one of the drugs he had “significant involvement with” was, in fact, Seroxat. (Also, the Chairman of the MHRA, Professor Alasdair Breckenridge, sat on Glaxo’s scientific advisory committee for many years.)

The strange thing is that on the day the House of Commons Health Select Committee wanted to hear evidence from the MHRA specifically about Seroxat trial data and safety, Professor Alaisdair Breckenridge (MHRA Chairman), Professor Kent Woods (MHRA CEO) and June Raine (MHRA Director of Vigilence and Risk Management) all managed to attend the hearing.

MPs had expected to be able to question Ian Hudson as well… unfortunately Dr Hudson could not attend as he had a prior engagement.

You can read the transcript of that session here – scroll down to question 783.

The MHRA and The House of Commons

In the UK part of the way that our Government works is through what are known as House of Commons Select Committees. Select committees are made up of members of parliament who come from all the parties in the Commons, not just the party who won the election. The idea is that they are able to investigate and perform checks and balances on aspects of modern life. Then then publish a report at the end of the investigation which can influence or change government policy. If you’re interested you can see a list of the Select Committees here.

The report that I want to draw your attention to today is Fourth Report of Session 2004-05 entitled “The Influence of the Pharmaceutical Industry.”

This is a very long and detailed report but is worth a read if you have the time and you can download a PDF here.

One of the recommendations can be read at paragraph 376: “During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust. Nor did we conclude that the MHRA provides the discipline and leadership that this powerful industry needs. We recommend that there be an independent review of the MHRA. The earlier review by the National Audit Office was designed expressly to assess the public expenditure aspects of the work of the agency; a more wide-reaching and in-depth review needs to be carried out to determine whether the processes now used for decision-making are adequate and reflect patients’ health needs and society’s expectations.”

The government response is here.

Nothing will change. The influence and power of the Pharmaceutical industry will see to that and in the meantime, patients will continue to suffer as more and more prescriptions for unsafe medicines are handed out.

Regulation in the UK – the MHRA

Here are some more ‘did you know’ moments.

It’s a surprise to many that regulation of drugs in the UK is not governed by the Department of Health. It was effectively ‘privatised’ and handed over to a body now named the MHRA which is entirely financed by the Pharmas. Its present chief executive worked for 27 years at GlaxoSmithKline, while its current Director of Licensing was Glaxo’s Worldwide Director of Safety in his last job. Regulators and industry are intimately intertwined.

The MHRA investigation into Seroxat has been heavily criticised for delays and lack of scientific rigour. Embarrassingly, the initial committee set up to look at the safety of Seroxat was force to disband after months of work. Half the ‘independent experts’ on the committee had links with GSK. Significantly and courageously Richard Brook, the mental health charity Mind’s Chief Executive at the time, resigned from the MHRA expert group on SSRIs. He said that continued membership was incompatible with Mind’s remit to represent the interests of mental health service users. He revealed that the MHRA had delayed publishing for ten years data they possessed of the dangers of Seroxat for children.

Mind has a distinguished record of tackling the might of the Pharmas. They take no money from the industry. The integrity of other charities may have been compromised; Depression Alliance admits to taking more than 80% of their funding from Pharmas in the recent past. Their mouths have been bandaged into silence throughout the exposure of the Seroxat scandal – Depression Alliance’s sole contribution to the debate was an attack on the accuracy of programmes on the subject made by the BBC’s Panorama .

Charities and patients’ groups depend on Pharmas’ cash. In a survey conducted, 18 charities involved in parliamentary lobbying said that they took donations; six refuse. Young Minds charity stated, “It is Young Minds’ policy not to enter into financial partnerships with Pharmaceutical companies. This enables the organisation to maintain its independence and avoid any possible instances of compromise.”

Many of these groups provide support for Commons All-Party. No declarations of interests are currently required. The groups may be used as Trojan Horses to wield influence in parliament. Full transparency is being sought.

Marketing vs R&D

Did you know that Pharmaceutical companies spend 2 – 3 times as much on marketing their drugs than they do on research and development?

What this means is they invent awareness of conditions that can be treated by their drugs.

The ballooning demand for anti-depressants is a phenomenon.

In barely a decade depression has gone from a rare disorder to being classed as the second major affliction of humankind. Can a thousand-fold increase be explained other than as deliberate marketing ploy to medicalise unhappiness? A new disease of social phobia has been invented, packaged and sold along with its anti-depressant cure. The repeated claim that drugs correct a faulty ‘chemical balance’ in the brain is a theory that has no scientific base. But millions of prescriptions are issued without any test of brain chemical activity. In the USA ten million children are dosed up with antidepressants. That includes 2 million prescriptions for Seroxat.

Pharmas have cynically created dependence on happy pills. Their fable is that life should by perpetual euphoria from cradle to grave. We have been conditioned to believe that if we feel sadder today than we felt yesterday, we are sick. Stress and depression are swelling epidemics in prosperous Western countries. The impoverished developing world has other things on their minds. But unhappiness, boredom anxiety even grief and despair are the inevitable trials of the human condition. They are to be endured not to be smothered with a drug. Grief suppressed is grief multiplied. Without misery, we would not recognize happiness. Most works of art are the products of anguish. If Beethoven and Michelangelo had been on SSRIs their creative animus would have withered.

This is the Pharmas’ greatest success in disease mongering and medicalising society. Their aim, expressed to Paul Flynn MP in a letter from GlaxoSmithKline (GSK) is that half of the population of the UK should be on anti-depressants at some time in their lives.

A drugged nation delivers bounteous Pharmas profits.

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