The drug has been linked in some studies with an increased risk for diabetes. Rosenheck said his team is eager to pursue studies analyzing the benefits of a new long-acting, injectable form of risperidone that is expected to become available and may result in better compliance. Rosenheck was named director of service use and economic assessment for the study. Results are expected in Schizophrenia, a biological disease of the brain, is the most common form of psychotic illness, affecting about 2.
It usually develops between ages 16 and Contrary to popular notion, the disease is marked not by a "split personality," but by delusions, hallucinations, and confused thinking. People with schizophrenia may have trouble carrying on a conversation or focusing on a task, and usually show flat emotions and a lack of interest in life. They are more likely to die early, because of a higher suicide risk and other issues that arise from their mental state, such as automobile accidents, medical problems or homelessness.
VA provides health care for about , veterans with psychosis. Of these, about half have schizophrenia and more than a third have bipolar disorder. VA spends 15 percent of its total health care budget on medical and psychiatric care for this population.
Rosenheck noted that while Eli Lilly and Company, the maker of olanzapine, did supply drugs and placebos for his study, the analysis was conducted with complete independence on the part of VA. For telephone or on-site interviews, please call his office at or contact Pamela Redmond at or pamela. For additional assistance, please contact Jim Blue at or james. Journal JAMA. Space to play or pause, M to mute, left and right arrows to seek, up and down arrows for volume.
Pharmaceutical company Eli Lilly makers of Prozac have agreed to pay upwards of 1. Secret documents are leaked, the newspaper headlines start screaming, and citizen journalists spread the word - but where is the real advocacy for better drugs with fewer side effects? Today on the show scandals, secret documents and side effects. Mixed messages about one of the world's biggest selling medications for the mind.
Philip Dawdy : Many people in the major media also access these same documents the way I access them on the internet and they've walked away from the story, even though there are definitely people out there who believe that this is a story on the level of what happened with Viox two years ago.
David Grainger : Well there's no doubt for anybody with a serious mental illness life is very much about managing the symptoms of the illness which, as you'd appreciate, can be very debilitating at times. Often that balance means weighing up the risk benefit balance I guess with any medication.
Sandy Jeffs : I think society has had a very, very, very fraught relationship with madness and this is shown in how we are treated and how we have been treated. And so doing nothing wasn't an option you had to do something no matter how barbaric it was. Natasha Mitchell : With the side effects though, and I guess the persistence of side effects with the medications over years, does it make you feel like a guinea pig? Sandy Jeffs : Yes it does in one sense, it also makes you feel quite despairing because the only thing that is going to make you OK in a sort of societal way are things that make you feel really horrible physically, or even emotionally sometimes you feel blunted by things.
Like the medication I take now if I take it I would be asleep in half an hour's time because it bombs me out no end. Natasha Mitchell : Pharmaceutical company Eli Lilly, they're the name behind the popular antidepressant Prozac. Reportedly though a third of their revenues and profits comes from another medication called Zyprexa or Olanzapine an antipsychotic drug approved for the treatment of schizophrenia and bipolar disorder. Zyprexa will be the number one neuroscience drug in history, was the company's claim.
But Zyprexa has now hit the headlines with claims that Eli Lilly downplayed data on known risks of major side effects; amongst them diabetes and weight gain. So far the company has agreed to pay upwards of 1. But as you'll hear, Eli Lilly doesn't think the claims have merit. Side effects are a reality of any medication but when they get the better of you and your mental illness has silenced you -- who then becomes your advocate?
Sandy Jeffs : I've had schizophrenia for 30 years so it's enough to make me have a PhD in psychosis I think and enough to give me a lot of experience of treatments and medications and the paradigm of psychiatry.
On the one hand I was diagnosed with this terrible thing called schizophrenia which people were going to find themselves be relentlessly ill, going down, down, down into the dark cave of madness never reappearing again from that dark cave. And the prognosis was really, really dire, it was awful to get that sort of horrible label -- schizophrenia, especially at Sandy Jeffs : Exactly, you know your just finding new friends and looking for jobs and trying to consolidate your identity and who you are in the world.
And when that's taken away from you by a psychotic illness you're left with nothing -- except medication. And I remember when I first went to Parkville Psychiatric Hospital there were all these people sort of sitting slumberously in vinyl-clad chairs and you know cigarettes trailing from nicotine-stained fingers and I sort of thought what's happened to all these people, what's wrong with them?
And much of it was the drugs they were taking, it wasn't just the illness, their medications had sedated them or actually worse was that the medications like Delazine made you have this endless restlessness. When you sat down your legs would jiggle like a marionette's and when you're standing up you'd pace the floor, you'd pace around and you couldn't stand still for five seconds and your mind was restless too.
I had an experience where at one stage my neck was cramping and my tongue was cramping and I was contorted downwards and I thought I was dying. Natasha Mitchell : Sandy Jeffs, speaking about the early days of the typical or conventional antipsychotic medications as they're known.
We know now that they were given in detrimentally high doses and, as it turns out, recent studies suggest they're still effective, perhaps just as effective as the new medications and certainly cheaper. But the arrival of the new atypical antipsychotics in the s was hailed as the dawning of a new era.
One of them was Zyprexa, also known as Olanzapine. Philip Dawdy is a Seattle based investigative journalist whose reporting on mental health has won him many awards.
He also runs a blog called Furious Seasons which he describes as one man's attempt to make sense of mental illness in America. Philip Dawdy : They have variously over the years worked very aggressively to get this into the mental health marketplace, for lack of a better term, in literally every doctor setting you could think of.
But yeah, they were greeted as silver bullets and wonder drugs and that's why they started kind of getting used long term in bipolar disorder once the effects of acute mania were knocked down over a week, two weeks, three weeks. It was felt you could use these drugs and there would be no problem for patients except paying for them because they are very expensive.
Natasha Mitchell : Sure are Zyprexa or Olanzapine has been at the centre of a great furore these past couple of months in the USA. You've been following it very closely -- take us back to December Philip Dawdy when the New York Times story first hit.
What was the story that broke? Philip Dawdy : The first story that broke alleging that Eli Lilly had been instructing its sales force to downplay the known risks of this drug while selling the drug to doctors. That's kind of in essence what the broad claim of that first article was. The reporting there, which was done by an investigative reporter at the paper named Alex Berenson, was based upon a bunch of documents, evidence in a court case that Eli Lilly had settled involving many thousands of patients.
Somebody in the loop of people found a way to leak them out to somebody else who got them into the hands of the New York Times and off the New York Times went. In additions to accusations of downplaying risks there were also accusations of off label marketing of the drug as it's called and in this country that means that they would have either been advertising or directly selling to doctors the drug for a purpose for which it was not licensed.
That's not allowed in this country. And we should let people know that these court documents were the basis of a pay-out by Eli Lilly in of million US dollars to some 8, claimants who said that they'd got diabetes from Zyprexa. Philip Dawdy : Or other injuries. There's a kind of a constellation of complaints if I remember correctly around those cases.
The broad subset of side effects that Berenson was going after in these articles was a risk created by this drug of inducing diabetes, of inducing hyperglycaemia -- obviously the two are connected there, as well as introducing just explosive weight-gain in patients as well as some questions of cardiac problems that may have been caused by the drug as well. Natasha Mitchell : I mean Eli Lilly have always been fairly up front it would seem about the weight-gain side effect, patients certainly know it really well.
Philip Dawdy : They really didn't initially and when I say they didn't initially, I mean patients, I don't mean Eli Lilly, they have been aware of the weight issue and probably later on to the diabetes issues and the hyperglycaemic issues. But you know Eli Lilly's principal obligation under the law in this country is to share that information with the food and drug administration. And the food and drug administration does an awful job of sharing that information both with doctors as well as patients, as well as the broader American public.
They will often say, if you try to ask them about things like this, and I have run into this as a reporter with them, that they'll say well that's private information, that's a trade secret for the company.
There were patients taking Olanzapine in this study who gained upwards of 40 pounds in a fairly short period of time. That's a problem. Natasha Mitchell : Twenty million people have reportedly taken this medication since it was introduced ten years ago, that's a lot of people for whom the medication is probably making a difference. Philip Dawdy : Yes it quite possibly is. Out of this class of atypical antipsychotics there's no question that Olanzapine and another drug known as Clozapine were considered the perfect molecules, for lack of a better term.
These were the drugs that could really address both the positive and the negative symptoms of schizophrenia. Natasha Mitchell : Philip Dawdy, you've been reporting as an award winning investigative journalist on mental health issues for many years now.
How serious is this story? Because I can hear people listening going, well I don't have schizophrenia, I don't have psychosis. Philip Dawdy : Well I suppose it would be one thing if this drug were just used for very acute cases of schizophrenia, because unfortunately the treatment options for schizophrenia are incredibly limited and it's just ridiculously sad, it's difficult to watch that -- as well as some fairly advanced cases of bipolar disorder.
But once you start getting into these milder mood cases with bipolar disorder and you start getting into the drug being used with some cases of depression, which it is, and it's being used with autistic kids sometimes as well as with older folks with dementia, you get into a zone where you're like wow, isn't that like hitting those symptoms with a sledgehammer?
Natasha Mitchell : Journalist Philip Dawdy, who's recently got hold of those sensational Eli Lilly documents via the internet himself and has published them on his website. It should be made clear that the antipsychotic medication we're talking about, Zyprexa, is only approved for use in Australia for the treatment of symptoms of schizophrenia and bipolar disorder.
Sandy Jeffs certainly wasn't aware of the prospects of weight gain when she started on the medication. The drug, she says, made a difference but the kilos became a burden. Sandy Jeffs : It did settle my psychotic symptoms a bit but not totally, I still experienced delusional thinking, and my voices never went away entirely anyway. But what I noticed was I started putting on weight. I'd go out with friends to restaurants and stuff and I would invariably eat more than anyone else at the table, I just had this ravenous appetite I just couldn't control.
And then I asked my doctor if I could change because I was really concerned about running around the hockey field like an elephant, and she said fine, fine, no worries. I went on to Abilify and that was disastrous. Sandy Jeffs : That was two years ago and it actually sent me more psychotic than I already was, and I went into a mania, chronic insomnia.
It was the most awful experience, I have to say, and since that time, two years ago, I've been very, very unwell for the entire two years, with lots of psychosis and depression and you name it, I've had it.
It's been a mind hell. Sandy Jeffs : Yes it was, yeah. I say to myself, do I blame myself for wanting to change the medication in the first place and upsetting the whole stability I sort of had? I sort of blame myself. But then what's wrong with wanting to look at your body weight and your body image, now we are driven by body image in this society? Because I felt really bad, I felt cumbersome in my own body, I hated it.
So I did change but it was disastrous, absolutely disastrous. And now I'm on Clozapine, which is a last-resort older drug which has been resurrected in terms of its use in modern psychiatry. Sandy Jeffs : Well, I don't know, I sort of describe it as the monster got out of its cage, the monster Madness got out of its cage, and I haven't been able to put it back in and secure the lock to lock it away.
It keeps creeping from its cage and I keep wondering, when is it going to stop, when will I wake up one morning and feel OK about getting up? It's really, really awful, I feel as though I've gone back 30 years.
Natasha Mitchell : Let's consider Olanzapine and that drug because it's certainly hit the headlines in recent weeks and the issue of weight gain is something that a lot of people experience isn't it? Sandy Jeffs : I don't recall being warned about weight gain or the possibility -- if you have weight gain you've got a possibility of contracting diabetes.
I know nothing was said along those lines. I have seen young women go from 60 kilograms to over kilograms -- the weight gain I have seen have been so significant and so obvious. Now body image for young women is really, really crucial in this horrible world we live in, we are so driven by it. And for someone like a young woman to go from 60 to kilos I mean in terms of mental health it doesn't help. Well let's hear then from Eli Lilly, maker of the antipsychotic med Zyprexa.
Their US headquarters have allowed an Australian representative to speak to All in the Mind on the company's behalf about the side effects of the medication - a rare interview on this issue. Unfortunately though, they're not prepared to comment on the ongoing US legal cases with their latest payout of up to million US dollars.
David Grainger is director of corporate affairs and health economics with Eli Lilly Australia. He's been with the company for nearly 30 years. David Grainger : One of the things about the antipsychotic medications is that they work as a class of medicines on a range of receptors in the brain.
And inevitably with that you also get a range of side effects; some drowsiness, sometimes effects that are more related to stimulation of other receptors and sites in the brain. And in the case of Zyprexa also some weight gain. Natasha Mitchell : In Eli Lilly Australia distributed a letter to Australian doctors informing them of the association between Zyprexa and hyperglycaemia -- or elevated blood sugar levels, just to explain -- and certainly other metabolic conditions related to diabetes.
What was the basis, David, of sending that letter to the medical community in Australia? David Grainger : Quite a complex little background to that, Natasha, you can appreciate people with serious mental illness, particularly schizophrenia, often have concurrent physical health problems.
Things like disturbances to blood sugar levels are not uncommon but it also became apparent that they're perhaps slightly more common in people taking antipsychotic medications. Natasha Mitchell : You'd know from talking to people with schizophrenia who take Zyprexa or Olanzapine -- and from studies -- that weight gain is a significant and frustrating side effect for some patients on this medication.
How does Eli Lilly view the side effect of weight gain? David Grainger : Well there's no doubt that for anybody with a serious mental illness life is very much about managing the symptoms of the illness, which as you'd appreciate can be very debilitating at times. Often that balance means weighing up the risk benefit balance, I guess, with any medication.
0コメント