The Hansard Society & Glaxo

The Hansard Society has active support from all political parties for our work in promoting effective parliamentary democracy.

We are an independent and non-partisan educational charity working to stimulate knowledge of and interest in democracy through research, publications, influential seminars, online debate and deliberation, groundbreaking activities with young people and public meetings. Our work aims to strengthen parliament by encouraging greater accessibility and closer engagement with the public.

The Society was formed in 1944 to promote the ideals of parliamentary government when it was seen to be threatened by fascist and communist dictatorship. Its first subscribers were Churchill and Attlee, the then Prime Minister and Deputy Prime Minister. From that time, the Prime Minister of the day and leaders of the main opposition parties have publicly supported the work of the Society and the Speaker of the House of Commons is our President”.

Given the aims and the history of the Society, it is a shame that one of its corporate sponsors is GlaxoSmithKline.

I’m sure regular readers of Seroxat Secrets will be aware of Glaxo’s attempts to undermine Parliamentary democracy when it was uncovered ‘warning off’ MPs in order to stop them signing critical Early Day Motions laid down by Paul Flynn MP.

The collected posts are here for your easy reference.

You might also like to look at Bob Fiddaman’s latest post on the Society and its Big Pharma sponsors.

Serotonin syndrome

This from an article in the New York Times today by Jane E Brody: A Mix of Medicines That Can Be Lethal

Recognizing the early signs is tricky because it has varying symptoms that can be easily confused with less serious conditions, including tremor, diarrhea, high blood pressure, anxiety and agitation. The examining physician may regard early symptoms as inconsequential and may not think to relate them to drug therapy.

In its classic form, serotonin syndrome involves three categories of symptoms:

• Cognitive-behavioral symptoms like confusion, disorientation, agitation, irritability, unresponsiveness and anxiety.

• Neuromuscular symptoms like muscle spasms, exaggerated reflexes, muscular rigidity, tremors, loss of coordination and shivering.

• Autonomic nervous system symptoms like fever, profuse sweating, rapid heart rate, raised blood pressure and dilated pupils.

Widespread ignorance of the syndrome is another diagnostic impediment. But even when doctors know about it, the strict diagnostic criteria may rule out “what are now recognized as mild, early or subacute stages of the disorder,” Dr. Edward Boyer and Dr. Michael Shannon wrote in their review in The New England Journal of Medicine.

Perhaps adding to the diagnostic challenge is the fact that a huge number of drugs — prescription, over the counter, recreational and herbal — can trigger the syndrome. In addition to selective serotonin reuptake inhibitors like Zoloft, Prozac and Paxil and serotonin/norepinephrine reuptake inhibitors like Effexor, the list includes tricyclic antidepressants and MAOIs (for monoamine oxidase inhibitors); narcotic painkillers like fentanyl and tramadol; over-the-counter cough and cold remedies containing dextromethorphan; the anticonvulsant valproate; triptans like Imitrex used to treat and prevent migraines; the antibiotic Zyvox (linezolide); antinausea drugs; the anti-Parkinson’s drug L-dopa; the weight-loss drug Meridia (sibutramine); lithium; the dietary supplements tryptophan, St. John’s wort and ginseng; and several drugs of abuse, including ecstasy, LSD, amphetamines, the hallucinogens foxy methoxy and Syrian rue.

Although serotonin poisoning can be caused by an antidepressant overdose, it more often results from a combination of an S.S.R.I. or MAOI with another serotonin-raising substance. Patients at particular risk, some experts say, are those taking combinations of antidepressant and antipsychotic drugs sometimes prescribed to treat resistant depression. All it may take is a small dose of another serotonin-inducing drug to cause the syndrome.

Most important to preventing the syndrome is for patients to give each of their doctors a complete list of drugs they regularly take — including prescriptions, over-the-counter medication, dietary supplements and recreational drugs — before a doctor prescribes something new.

Indeed, if you are taking any of the drugs described above, you might ask whether a new prescription is safe. And when filling a new prescription, it’s not a bad idea to also ask the pharmacist whether the medication, or an over-the-counter remedy you are considering, is safe to combine with any other drugs you take.

Great – so we now know that Serotonin has nothing to do with causing depression or curing it – but it can cause Serotonin Syndrome…

Will someone please, please tell me what’s going on?

And as if by magic…

On the very day I write up Johann Hari, and wonder what he’s up to now, what happens?

Bob Fiddaman points out Hari’s latest Seroxat piece tonight in the Evening Standard. The link is here.

How weird is that?

Not sure it’s worth reading and I still think the boy Hari has a LOT to learn about Seroxat and Depression, but what a fantastic coincidence.

Johann Hari’s Seroxat journey

Some of you may know the name Johann Hari – he’s a newspaper columnist from the UK and he’s written about his use of Seroxat on a few occasions.

It’s an interesting journey to document.

In the Independent in 2003 he wrote: “…The problems caused by extreme ecstasy use (and the widespread problem of depression caused by other, unknown factors) can, thankfully, be largely rectified by SSRIs. But there is at the moment an irresponsible scare campaign – orchestrated by sections of the media that should know better – that is stigmatising SSRIs.

A tiny number of suicides have been tenuously linked to anti-depressants, and on the basis of these unproven accusations, an entire demonising bandwagon has been put on the road.”

He went on: “Many people do have problems coming off the drug, but since I never intend to come off (and I think any depressive who tries is crazy), why should that bother me? Dependency in itself is not a problem. I am dependent on food and water and oxygen and the maintenance of the social fabric around me. Diabetics are dependent on insulin, and I don’t hear anybody lecturing them to wean themselves off.

Nor do SSRIs turn people into zombies, or make them incapable of thought; these are stereotypes left over from the old, terrible antidepressants such as lithium. I feel things just as keenly as I ever did; the difference is that Seroxat prevents one dark feeling – of emptiness and self-loathing – from overwhelming all the other, more subtle and interesting feelings.

I often wonder why the impact of SSRIs is not more widely appreciated. One of the great, lingering curses of the human condition – depression – is now, in all but a small number of cases, treatable”.

Clearly Johann was a FAN.

In 2004 he wrote a piece in the Independent on Sunday entitled “In defence of Seroxat”: “Seroxat saved my life. It’s as stark – and stupidly melodramatic – as that. I was eighteen, lost and suicidal. I couldn’t sleep; I couldn’t eat; I could only think fitfully, in manic bursts in-between tears. I was becoming unanchored from reality, alternating between being shut morosely in my room and wild, anarchic sociability.

And then came my small blue tablets – 30mg of sanity once a day – and success. Seven years on, I have never once doubted or cursed my Seroxat. Like the vast majority of people who use it, I have found – for the first time in my life – a sense of coherence and control.”

However, by August 2006 Johann was changing his mind: “… I have never regretted taking the anti-depressants to lift me out of the depression, and I never will, but I began to wonder if they were really a lifetime companion rather than a long fling. I sensed somewhere that they had drawbacks, but I could never really articulate what they were…”

“… although depression is a disease, unhappiness is not. On the contrary, it is an essential state, a signal we all need from time to time to show us when our lives are going wrong. Stripped of that signal, it is easy to lose your way – as many, many people who take antidepressants too long do….That’s why I have decided, with one last synthetic tear, to bid antidepressants goodbye.”

By October 2006 this was what was happening: “I have spent this week in bed shivering, sweating and in withdrawal. No, I haven’t done a Pete Doherty – as my mother reassured me recently, “I know you’re not a junkie son, you’re far too fat”. My drug is legal, my dealer for the past decade has been my GP, and this withdrawal is Officially Sanctioned. It is called Seroxat, sister of Prozac, proud member of the SSRI family of anti-depressants. This is the first week of my adult life where I have had only a trace ten milligrams of Seroxat in my bloodstream – and it feels…”

” So why? Why now? After a decade of joy, after spending all my adult life chemically enhanced, why stop? … over the past two years I have slowly begun to realise that, in addition to their great, glorious strengths, anti-depressants cause slow, subtle problems too.”

So I want to know what it is like, to be an ordinary undepressed, undrugged adult. How much of this is me, and how much is the medication?

Of course I am anxious. Could the depression come back? Will the withdrawal be agony? Will my ugliest character traits re-emerge from below the Seroxat? But I also know there will never be a better time – when I have a job and a life I love – to try.

I’m taking it slowly. I’m cutting back by inches. I’m gently – very gently – acclimatising to the colder climate beyond Seroxat. And so far, from my sick-bed, it feels… yes, it feels okay. I am beginning to cry at films again – warm, healthy tears – and to feel flickers of rage at small irritations. It feels real. It feels human. It feels like me, after all these years.”

It sounds like Johann has been very lucky – Seroxat didn’t harm him while he was taking it – or not that he has noticed yet. I wonder if he’s ever looked in on Seroxat Secrets? There’s a whole lot to learn about this stuff, Johann and here’s as good a place as any to start.

I hope the withdrawal is going well.

Seroxat and birth defects

In another great article, Evelyn Pringle writes about Paxil Birth Defect Litigation – Battle of the Decade.

Just over a year ago, the FDA reclassified Paxil (Seroxat) from a Category C drug to a Category D for pregnant women. Category C is for drugs that have been shown to harm the fetus in animals. Category D means a drug has been found to harm the human fetus.

In a December 1, 2006 news release, the American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice, advised that Paxil should be avoided “by pregnant women or women planning to become pregnant due to the potential risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative effects.”

An interesting comment in the announcement states: “Unpublished data regarding the use of Paxil during the first trimester of pregnancy have raised concerns about an increased risk of congenital heart malformations.”

This discussion begs the question of exactly how much more “unpublished data” is out there about the dangers of Paxil that the public will hear about later, rather than sooner.

Please go and read Evelyn’s great (as ever) article – the link is at the top of this post.

Thanks also to Mouse at Paxil Progress and Truthman30 for reminding me about this horrible aspect of Seroxat.

The FDA scandal

The MHRA in the UK and the FDA in America are supposed to be on the patients’ side and work to protect the public.

Today in the Boston Globe, there is a great piece about the inner workings (and failings) of the FDA. In Taking back the FDA, Marcia Angell writes:

“Before a prescription drug can be sold, the manufacturer must conduct clinical trials to prove to the FDA that the drug is safe and effective. Without that, doctors have no way of knowing how good or bad a drug is. Just trying it out would be not only risky, but unreliable, since individual experience can be misleading. The scrutiny that this agency exists to provide is vital to our health.

However, by the end of her article, Marcia concludes that:
“The FDA now behaves as though the pharmaceutical industry is its user, not the public”.

In just the same way that more and more people in the UK are calling for an independant review and overhaul of the MHRA, so the same is true of the FDA in America.

Taking back the FDA is well worth 5 minutes of your time.

This simply can’t be allowed to go on.

Fiddaman polls MPs

Bob Fiddaman over at Seroxat Sufferers – stand up and be counted is on a roll at the moment.

A few days ago he emailed well over 100 Members of Parliament, asking them to read the information on his site and other sites doing the rounds on the internet.

He set the emails up with a ‘read request’, basically confirmation that the MPs had read the email.

Go to his Members of Parliament post here to find out what the responses have been so far…

What I love about today’s internet is the way that we (ordinary members of the public) are now empowered and able to do things like this.

Former Pharmaceutical Rep speaks out

Gwen Olsen is a woman who used to be a pharmaceutical sales rep for 15 years until her niece killed herself while taking antidepressants. Gwen has written a book called, “Confessions of an Rx Drug Pusher.”

However, what I’d like to recommend to you is Gwen on YouTube. The first link is here and Gwen talks about her time working in the pharmaceutical industry and tells us exactly how drugs are marketed and approved in America.

In the second link here, Gwen tells us about her own personal experience of being prescribed SSRIs.

The third link (here) is an interview that was only on broadcast on the web from http://www.cbs.com. In it Gwen discusses the prescription of anti-psychotic drugs to children.

All the videos are well worth watching.

3 years on and the FDA have done nothing

David Healy made a submission to the FDA in February 2004. The Executive summary is below and the full paper can be read here:

The enclosed document arose from a direct invitation from Dr. Robert Temple, Director of the Office of Drug Evaluation I, of the Food and Drug Administrion, in the course of a meeting organised at FDA on February 3rd 2004. The meeting was focussed primarily on the issue of suicidality in children taking SSRIs. But this issue does not stand alone. It would appear that we have reached a crisis point in both the regulation of psychotropic drugs and perhaps all drugs and a crisis point in psychiatry and perhaps all of medicine. It will become clear from the material laid out here that most if not all of the supposedly scientific literature on giving SSRIs to children may be ghost-written. It also seems clear that FDA do not know basic things about the use of these drugs such as how many people are on the drugs.

This paper offers a model that for the first time gives an estimate as to likely numbers of people who have taken Prozac, Paxil and Zoloft since their launch in the US. From this it is possible to derive an estimate of the numbers of people who have committed suicide over and above the numbers who would have committed suicide had SSRI drugs never been marketed. This points to a figure of 21,000 excess suicides. It seems quite likely that when this model is in due course fed real figures from actually dead people, that this estimated figure will appear conservative.

One way out of the problem is outlined in this paper, namely to adopt a system that encourages consumer reporting of adverse events. The current crisis makes it clear that consumer reports are often considerably more accurate than physician reports.

The material laid out here gives rise to a series of questions for FDA:

In the light of Traci Johnson’s death on February 7th 2004, will FDA obtain Pfizer’s entire folder on the 1982 Hindmarch study in which healthy volunteers were given Zoloft, and make a statement as to whether data of this kind can indicate whether SSRIs can induce suicidality?

Will FDA undertake to obtain all of Glaxo SmithKline’s trials in children and make available an analysis of all the data in regard to suicidality and aggressive behavior?

In the light of the details below, will FDA comment on their characterization of the British approach to the question of the risk benefit ratio for SSRIs in pediatric populations as superficial?

Will FDA confirm that companies have inappropriately coded suicidal acts under the heading of placebo in trials of Prozac, Zoloft and Paxil in adults, and will the agency give a true set of figures for the suicidal acts on both active treatment and placebo in registration trials for adults?

Given that Paxil/Seroxat shows the greatest number of withdrawal syndrome reports to WHO for any psychotropic drug ever, and given that the full dimensions of this problem remain unknown, with the company changing its estimates as to the frequency and severity of the problem at regular intervals, will FDA outline exactly how a randomized withdrawal design could demonstrate these drugs work for either children or adults?

Given the abundance of evidence that physicians commonly increase the dose of SSRIs when faced with a patient not doing well on treatment, particularly during the early phases of treatment, what advice will FDA offer to doctors to minimize the risk of this happening inappropriately?

What will FDA do to remedy the incredible fact that Americans track the fate of parcels through the post 100 times more accurately than they track the death of children and adults on these drugs?

Specifically, in the light of the failures of physicians to report adverse events, will FDA consider an initiative begun by the mental health charity, MIND (UK) to foster consumer reporting of drug induced adverse events?

Seroxat and Violence – the link is made

Published on September 12, 2006, this study by David Healy, Andrew Herxheimer and David B. Menkes deals with an issue that cannot be ignored. So many people take Seroxat and find it starts to give them unexplained violent and aggressive episodes.

“Recent regulatory warnings about adverse behavioural effects of antidepressants in susceptible individuals have raised the profile of these issues with clinicians, patients, and the public. We review available clinical trial data on paroxetine and sertraline and pharmacovigilance studies of paroxetine and fluoxetine, and outline a series of medico-legal cases involving antidepressants and violence.

Both clinical trial and pharmacovigilance data point to possible links between these drugs and violent behaviours. The legal cases outlined returned a variety of verdicts that may in part have stemmed from different judicial processes. Many jurisdictions appear not to have considered the possibility that a prescription drug may induce violence.

The association of antidepressant treatment with aggression and violence reported here calls for more clinical trial and epidemiological data to be made available and for good clinical descriptions of the adverse outcomes of treatment”.

The link to the paper is here and I suggest you scroll down to the end and read the 9 cases listed in the annex.

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