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Old 05-12-2013, 12:01
Docta Docta is offline
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Seroquel: anti-psychotic being prescribed despite growing concern about its side effe

Transcript of intervene,Australian Broadcasting Corporation Broadcast: 27/11/2013 Reporter: Louise Milligan
LEIGH SALES, PRESENTER: Ailments like anxiety and depression are being diagnosed more and more, and alongside that, the prescription of heavy duty drugs to treat the conditions has grown too. The use of one drug in particular has skyrocketed. The anti-psychotic commonly marketed as Seroquel is supposed to be used for serious illnesses like schizophrenia and bipolar disorder. But a vigorous marketing push by its American manufacturer has led to it being widely used for a range of common complaints, from insomnia to eating disorders. Now, doctors are warning the drug is being massively overprescribed and the potentially dangerous side-effects are being ignored.


Louise Milligan reports.

LOUISE MILLIGAN, REPORTER: Heidi Everett is singing about being diagnosed with schizophrenia.

For more than a decade, Heidi has been on the drug Seroquel. An anti-psychotic, it acts as a powerful sedative.

HEIDI EVERETT: So, I was a zombie for 24 hours a day, sleeping incredibly long. When I did finally get out of bed, it was a struggle to get to the kitchen and then what happens on Seroquel is that it freezes your muscles and shuts your muscle system down. So, it's really hard to walk, and when I did walk, I had no control over my ability to stop walking, so I walked into walls.

LOUISE MILLIGAN: She also developed a heart condition known as tachycardia.

HEIDI EVERETT:
It's where your heart starts beating extremely fast and out of control, and I don't mean just like a little flurry, I mean for two or three hours of extreme, just pounding, fast heart rate.

LOUISE MILLIGAN: Heidi is not alone.

WOMAN (YouTube footage): Anybody out there that's trying to get off Seroquel, I am feeling for you like you wouldn't believe.

WOMAN II (YouTube footage): I hate it, I absolutely detest it. It's like wading through mud. It's dreadful.

LOUISE MILLIGAN: Seroquel, sold by pharmaceutical giant AstraZeneca was approved for use for schizophrenia and bipolar disorder.

ERIK MONASTERIO, FORENSIC PSYCHIATRIST, UNI. OF OTAGO: It's very interesting that when it was first coming onto the market - I think I speak on behalf of my colleagues as much as myself - we were very excited about this medication because it read very well on paper.

LOUISE MILLIGAN: The medical community was concerned about the addictive qualities of other sedatives, benzodiazepines like Valium.

IAIN MCGREGOR, PSYCHOPHARMACOLOGIST, UNI. OF SYDNEY: This gave rise to what I call benzo-phobia - people became terrified of prescribing benzodiazepines to their patients because of the fear of addiction and tolerance and withdrawal. So they looked for alternatives, and round about this time, Seroquel appeared.

LOUISE MILLIGAN: In Australia, Seroquel has now become a blockbuster drug. Over the past decade, Medicare statistics show the prescribing of Seroquel grew from about 1,500 scripts a year in 2000 to almost a million by the end of last year, a trend not mirrored by other anti-psychotics.

IAIN MCGREGOR: Seroquel is a marketing and commercial triumph. Whether it's a triumph for medication, I'm not so sure.

ERIK MONASTERIO: How has it come about that a medication that's been designed for the treatment of a very rare condition has become so popular? That is the ultimate question that needs to be answered.

IAIN MCGREGOR: AstraZeneca realised, as many other pharmaceutical companies did, that the market in schizophrenia is very static. So, about 0.8 per cent of the population will suffer from schizophrenia and that is a relatively small market compared to, say, depression. So there's been a number of strategies that have been used to try and penetrate the depression market.

LOUISE MILLIGAN: Psychopharmacologist Professor Ian McGregor has chartered with extreme concern the explosion and use of this anti-psychotic being prescribed for a host of maladies for which it is not approved or intended.

IAIN MCGREGOR: So we see Quetiapine being used in anxiety, it's used in depression, it's being used for insomnia, it's used a lot in people who have drug and alcohol problems, it's used in things like anorexia nervosa. I think of it as the Swiss Army knife drug. So if you look at a Swiss Army knife, it has all these different tools within the one tool for different application.

LOUISE MILLIGAN: It's known as off-label prescription - doctors prescribing medication for uses not approved by the regulatory authority. It's thought that a big growth area is insomnia.

IAIN MCGREGOR: It's a very powerful tranquilliser; particularly in higher doses, it will send people straight to sleep. It's very good at doing that. But if you look at the long term effects, they can be very serious.

LOUISE MILLIGAN: Until last year, Seroquel, an anti-psychotic, was the fifth largest selling pharmaceutical of any kind, generating $6 billion in global sales for its manufacturer AstraZeneca. In 2012, the patent for Seroquel expired and AstraZeneca's sales plummeted. But, it's estimated that sales of the generic drug, Quetiapine, have only increased because it's so much cheaper.

Matthew Frei is the clinical director at Melbourne's Turning Point drug and alcohol centre. Over the past few years he has seen some worrying developments with the drug.

MATTHEW FREI, CLINICAL DIRECTOR, TURNING POINT: Well we're seeing people getting toxicity from the drug, so that's things like oversedation, collapse and even overdosage where people required admission to hospital, and there have been recorded deaths as well.

LOUISE MILLIGAN: He asked epidemiologist Belinda Lloyd to look into ambulance data to see how often Seroquel, clinically known as Quetiapine, was showing up.

BELINDA LLOYD, EPIDEMIOLOGIST, TURNING POINT: So we examined Quetiapine-related ambulance attendances over a 10-year period and looked at those in the context of other drugs that are used for the same purposes and in the same drug group and what we found was a really substantial increase over the decade in people being attended by ambulance as a result of inappropriate Quetiapine use.

LOUISE MILLIGAN: In just a decade, ambulance attendances for emergencies associated with the drug rose from 32 a year to 589 a year. This wasn't seen with other similar anti-psychotics.

And Victorian Coroners Court statistics for the past three years show it contributed to 10 per cent of drug deaths.

Matthew Frei says, worryingly, a black market in the drug has emerged.

MATTHEW FREI: So people prescribe the drug, giving it, selling it, trading it with friends, you know, who may - who aren't prescribed the drug.

ERIK MONASTERIO: It's known as Susie-Q, Baby Heroin, Quell.

LOUISE MILLIGAN: Forensic psychiatrist, Dr Erik Monasterio, works in a jail in New Zealand where Seroquel was prescribed to sedate prisoners. He noticed, to his surprise, the inmates started requesting it by name.

ERIK MONASTERIO: And they were citing all sorts of non-specific symptoms in order to get hold of that medication. I became alarmed about this inappropriate use of the medication and thereafter tried to phase the medication out of that clinical setting.

LOUISE MILLIGAN: The biggest side effect is explosive weight gain and diabetes.

MAN (YouTube footage): I really feel like I am paralysed with the weight gain. I can hardly even walk anymore.

WOMAN III (YouTube footage): I hate Seroquel. I gained so much weight. I felt, um, like nothing, you know, I felt like a zombie.

HEIDI EVERETT: So I was about 60 kilos before I was diagnosed and I went up to about 120 kilos afterwards.

IAIN MCGREGOR: There was one study with children where kids on Seroquel put on about seven kilos in the first 10 weeks that they were on the drug. That's fairly major weight gain.

LOUISE MILLIGAN: In the United States, AstraZeneca has been hauled through the courts. In 2010, the company paid a $520 million settlement for allegedly marketing the drug off-label.

IAIN MCGREGOR: It came to light that during the approvals process AstraZeneca covered up some of the major side effects of Seroquel in order to get it easily approved.

LOUISE MILLIGAN: In a statement to 7.30, AstraZeneca Australia says it does not promote Seroquel for off-label uses. In its US television commercials, AstraZeneca now includes long disclosures about a whole range of side effects caused by the drug.

The worst of the side effects is, of course, death. Quetiapine has been associated with sudden heart failure and a study in The Lancet medical journal tracking Quetiapine patients in Finland over 10 years found disturbing trends.

IAIN MCGREGOR: They were more likely to be dead after 10 years than patients who were on other anti-psychotic drugs and there was also an increased risk of suicide as well. And this is one of the ironies of this massive increase in the prescription rate in Australia: when you stack it up against other medications and other treatments, it doesn't really stand out as a particularly good drug.

LOUISE MILLIGAN: Heidi Everett says reliance on drugs like Seroquel is symptomatic of an overburdened mental health system which copes by drugging patients up.

HEIDI EVERETT: I'm desperate for change in the mental health system, and not just me, all the people I know who have a diagnosed mental illness. We're just crying out for better help and better support that doesn't involve just medicating.

LEIGH SALES: Louise Milligan with that report... and, as always, patients should not drop or change medication without doctors' advice.

This is the statement provided to 7.30 by AstraZeneca Australia:

"Quetipine fumarate is a proven and effective medicine for its registered indications of schizophrenia, bipolar disorder, major depressive disorder and generalised anxiety disorder.

"The medicine has been independently reviewed and licensed by the Therapeutic Goods Administration for these conditions.

"It is a fact that thousands of Australians have benefitted for being able to access this treatment for what are often difficult and complex mental health disorders.

"Doctors face constant challenges in dealing with patients with complex mental health conditions and need to be aware of the risk and benefits of recommending medicine and other therapies for these complex conditions.

"It is not helpful to demonise doctors, patients or the medicines they take for their condition.

"Rather our focus is to support prescribers to champion the appropriate use of medicine and ensure that patients receive this treatment only when there is a clear medical rationale for doing so.

"AstraZeneca does not promote or condone any use of quetipine fumarate which is not consistent with the registered or approved indications."

http://www.abc.net.au/7.30/content/2013/s3900419.htm

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