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.

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.

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