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Drug Company Puts Profits Before People Shock, Horror from the New York Times

#1 User is offline   MG 

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Posted 10 March 2008 - 12:51 PM

Lilly Waited Too Long to Warn About Schizophrenia Drug, Doctor Testifies


By ALEX BERENSON
Published: March 8, 2008

ANCHORAGE — Eli Lilly, the drug maker, could and should have warned physicians as early as 1998 about the link between Zyprexa, its best-selling schizophrenia medicine, and diabetes, an expert witness told jurors Friday in a lawsuit that claims that Zyprexa has caused many mentally ill people to develop diabetes.

Instead, Lilly hid Zyprexa’s risks from doctors to protect the drug’s sales, according to the witness, Dr. John Gueriguian. Lilly waited until 2007 to add strong warnings to Zyprexa’s label to reflect the drug’s tendency to cause severe weight gain and blood sugar changes.

Lilly put “profit over concern of the consumer,” Dr. Gueriguian said Friday near the end of four hours of testimony.

Zyprexa, a drug for schizophrenia and bipolar disorder, is by far Lilly’s top-selling product, with worldwide sales of $4.8 billion last year.

The company has said it did nothing wrong and fully disclosed what it knew about Zyprexa to the Food and Drug Administration.

Dr. Gueriguian is testifying on behalf of the State of Alaska, which has sued Lilly to recover its costs for treating Medicaid patients who developed diabetes after taking Zyprexa. The trial is being heard in state court in downtown Anchorage before a jury of seven women and five men.

Dr. Gueriguian is a specialist on diabetes and was a medical reviewer for the Food and Drug Administration for 20 years before retiring in 1998.

At the F.D.A., he recommended against the approval of Rezulin, a diabetes drug that was later withdrawn for causing severe liver damage in patients.

Under examination by Tommy Fibich, a lawyer from Houston who is representing Alaska, Dr. Gueriguian methodically reviewed about a dozen documents in which Lilly scientists and executives discussed the potential links between Zyprexa and diabetes.

Zyprexa was introduced in September 1996 and hailed as a breakthrough medicine for the treatment of schizophrenia.

But doctors quickly began to report to Lilly that patients suffered severe weight gain, high blood sugar and even diabetes after taking the drug.

By the fall of 1998, the combination of adverse-event reports, clinical trial data that showed hyperglycemia and weight gain, and problems in animal studies should have been enough for Lilly to warn doctors about Zyprexa’s links to diabetes, Dr. Gueriguian said. Instead, the company did nothing.

Documents from 1999 and 2000 also showed that Lilly was accumulating evidence of Zyprexa’s risks but not sharing it with doctors, he testified.

And in 2002, only 10 months after Lilly began selling Zyprexa in Japan, medical regulators in that country required Lilly to warn doctors against using Zyprexa in diabetic patients.

But Lilly did not issue a similar advisory to doctors in the United States. Instead, the company advised its sales representatives not to discuss diabetes with doctors unless the doctors brought it up first, according to another document presented at the trial.

“We will NOT proactively address the diabetes concerns,” the document, an internal Lilly memorandum, said.

Court recessed on Friday before lawyers for Lilly could cross-examine Dr. Gueriguian. They will have the opportunity to do so on Monday.

A lawyer for Lilly said after Dr. Gueriguian’s testimony that the company had shared all it knew with the F.D.A. and that the question of the link between Zyprexa and diabetes was still a subject of scientific debate.
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#2 User is offline   Hardwired 

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Posted 11 March 2008 - 05:47 AM

A Link to Choice fo Wellness.
This site has data re the likes of info MG has posted above and also includes a forum for public and members of the site,


http://prawi.sartorelli.gen.nz
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#3 User is offline   Hardwired 

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Posted 11 March 2008 - 06:00 AM

PATIENTS' RIGHTS ADVOCACY
Waikato Inc.
65 Tawa Street, Hamilton, New Zealand
Telephone: International + 64 – 7 – 8435837
Contact: Anna de Jonge
Email: [email protected]
PRAWI Community Adult Education



INTRODUCTION

Established in the early 1980s, Patients' Rights Advocacy (PRAWI) became an incorporated society in 1988. Membership is currently 400, including a number of law firms, health practitioners and organisations with an interest in patients' advocacy. Funding is by subscriptions, donations and grants.

The Society is linked to a number of similar patients' advocacy groups overseas and while regular contact is maintained, the internet and e-mail provide immediate updates on International news, issues and developments in the field of patients' advocacy. We assist patients to exercise their rights in the health area; encouraging compliance with laws and codes of practice within the health professions and empowering people with information and knowledge to enable them to be more responsible when dealing with the health system.

In 1998 the Hon. Bill English stated that New Zealand had the highest rate of adverse reactions to drugs in the world. We want to reverse these statistics by educating patients about drug effects. We are educating the public and the Government on the effects of Benzodiazepine drugs i.e. addiction and horrible withdrawal effects. When patients compare stories on drug effects, it is evident they were not given full information on drugs prescribed even though the law requires this.

In 1999 the Benzodiazepines were reclassified as controlled drugs under class C. Many patients have been taking Benzodiazepines for years without recognising the effects. Common Benzodiazepine drugs are: Ativan, Valium (diazepam), Mogadon, Halcion, Xanax, Rivotril, Rohypnol, but there are numerous others in the category. These drugs create the various effects they are intending to treat: e.g. anxiety, stuttering, blurred vision, muscle fatigue, agoraphobia, fears, anger, memory loss, confusion, lack of concentration, sleep disturbance and more adverse effects.

There are restrictions on the prescribing of Benzodiazepines of which many people are unaware. Withdrawal from these drugs must be gradual and monitored. No psychotropic drug should be stopped suddenly because of the risk of rebound effects which can be extremely severe.

Patients Rights' Advocacy Waikato Inc, assists patients in making complaints, affidavits, attending and organising seminars, assisting with research on health, preparing compensation claims for personal injury by accident, Medical Misadventure, Medical Error and Benzodiazepine claims for submission to the ARCIC. The Society has also been successful in overturning a number of previous ACC decisions.. :)

Some of our members have published their own books, videos and stories. These stories have had healing effects for others similarly affected by drugs or adverse treatments. Validation of what happens to people 'behind the scenes' in the health system is very important. Other members are unable to read, write, remember or comprehend because of iatrogenesis. This reinforces the commitment of the group to work and educate in a role, preventing doctor induced injuries (iatrogenesis) wherever and whenever possible.

PRAWI OBJECTIVES

The objectives of Patients' Rights Advocacy Waikato Incorporated are:

to assist patients to exercise their rights in the health area and to improve and encourage compliance with laws and codes of practice.

To provide people with information and knowledge to enable them to be responsible for their own health.

To promote accountability within the medical profession, including correct diagnosis and a code of rights.

To assist with obtaining personal records, informing patients about their legal rights, assisting with legal representation, personal injuries by accident, Medical Misadventure Benzodiazepine Claims, redress through the Accident Rehabilitation and Compensation Insurance Corporation.

Patients' Rights Advocacy Waikato Incorporated exists to assist patients and, provide assistance to any patient, either in or out of hospital. It is independent of providers. Our aim is to help people with the lodging of complaints. We are concerned about the malpractice, procedures for informed consent, and the lack of it. Doctors can no longer be their own judge and jury. The public needs more than national 'guidelines', it needs legislation. We have 'guidelines' now, but they do not work well for clients.

The patient must know what is going on. The patient should be protected. The patient has our full support.

PRAWI MISSION

The Key Objective is to empower people with knowledge on a wide range of health related issues such as iatrogenesis, a situation which is drug induced by medical intervention.

Members receive a Resource Handbook outlining good contacts, literature and videos, which assist with understanding patients' rights, informed consent and choices.

Our pamphlets provide information highlighting the direct effects of psychiatric drugs. This information is not readily disclosed to the patient.

We also help patients to obtain copies of their medical records and assist victims of iatrogenesis.

Patients' Rights Advocacy is totally independent of any of the government funded health, education and advocacy providers.

Patients' Rights Advocacy provides individuals and organisations with support, education and training. It has a close working relationship with a number of law firms throughout the country.

ANNA DE JONGE



Anna de Jonge is a Patients' Rights Advocate at Hamilton, New Zealand. Anna did her Post Graduate Operating Theatre training at Rotterdam, The Netherlands and worked for thirty years in the medical profession, including twenty three years as an operating theatre charge sister of ten operating theatres at Health Waikato, Hamilton, New Zealand.

Anna also studied Ethics in Science and Medicine in 1984 and Women and The Law in 1988, at Waikato University, Hamilton New Zealand.

Her work focuses on issues of Patients' Rights and their impact on the lives of people. She has published ten papers [see below] on the misuse of psychiatric drugs at national and international conferences.

The recently compiled information pamphlet on Patients' Rights Advocacy outlines the approach to victims of unwarranted drug administration: information on the dangers and effects of such prescriptions and the help, advice and comfort that the Patients' Rights Advocacy offers with the address and telephone number.

In September 2000, Anna advocated for a patient in an Accident Compensation Review claim, which had been declined for cover for a Benzodiazepine claim in respect of personal injury by Medical Misadventure through the prescription and addiction of Halcion (triazolam) a Benzodiazepine.

The decision of the Review Officer was in favour of the patient. She won on Medical Error.



PATIENTS' RIGHTS ADVOCACY
Waikato Inc.
65 Tawa Street, Hamilton, New Zealand
Telephone: International + 64 – 7 – 8435837
Contact: Anna de Jonge
Email: [email protected]
PRAWI Community Adult Education
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#4 User is offline   Shapeshifters 

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Posted 12 March 2008 - 06:34 AM

Hardwired

'Great bit of information'

This paragraph below guts me

In 1998 the Hon. Bill English stated that New Zealand had the highest rate of adverse reactions to drugs in the world. We want to reverse these statistics by educating patients about drug effects. We are educating the public and the Government on the effects of Benzodiazepine drugs i.e. addiction and horrible withdrawal effects. When patients compare stories on drug effects, it is evident they were not given full information on drugs prescribed even though the law requires this.

Accountability and compensation ,these politicians should be hung, so many good people have suffered from their B/S
These bastards made policy and allowed this crap into the medical arena and created alot of sick people and pharmaceutical junkies out of alot of us
Nothing changes
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#5 User is offline   Sparrow 

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Posted 12 March 2008 - 09:38 AM

A hospital Specialist refused to accept I had a drug reaction which was serious.
I told him I would not continue to use it till he could assure me the reactions I was having were safe. He couldnt, but instead offered me the services of a SHRINK.

I had a rare allergy, but looking up the net, it wasnt that rare and there was all the info, even to my symptoms of ANAPHYLACTIC SHOCK as a result of the allergy.

I would have thought that in this day and age of computers, it would have been pretty easy to investigate my allergic reactions!

He now has asked me to use this medicine, get a reaction and go to the Hospital Lab and get a test for Anaphylactic shot. You've gotta be joking!!
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#6 User is offline   MINI 

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Posted 12 March 2008 - 10:11 AM

Sparrow

Dont blame you for having nothing to do with it.

I too had bad reation of daily migraines from change in lower cost medication for supplier of VB12 I get each three month.

It went from Glaxo, which is a good reliable brand to something else and immediatly I had bad reaction. Problem is that the stuff is in your system for three months once given.

I refused to have the same injection next three months so had a change, not back to Glaxo, but some other brand.


It is not so bad, but still not as good as Glaxo. Pharmac dont even import Glaxo anymore, so no way can I have it.

Had regular dose recently and asked they they make sure they dont give me the wrong one, got told that it has been taken off the market as too many people complained about it. Different symtoms as mine. But maybe because my migraines are so disabling, I didnt take too much notice of any other symtoms. I dont know. But think I am slowing coming right again. It was hard trying to do my ACC, IRD cases, with the headaches affecting my eyesight and need to take off to bed to put head under the pillow.

Toooo bloody much, they take the good one off the market just cause it costs a bit more.

They dont think about the cost to the patient and how dependant you become on others, by the effects. And once able to look after yourself to becoming disabled completely.

Not good I say and thank you for this thread it is most interesting.

Cheers
Mini
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#7 User is offline   Medwyn 

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Posted 12 March 2008 - 01:35 PM

Another problem we have is the fact that the American Mega drug companies fund both research and "University Chairs" at different learning hospitals.

This leads to a problem when a US trained psych comes down here and is unfamiliar with the MAOI drugs prescribed here which are of non US origin and not sanctioned by the Federal Drug Administration ( which IMHO, is US biased!!!) and they persuade their clients to stop their current meds and switch to an SSRI or something the psych is familiar with (ie US manufactured and with all the 'perks' that go with it.

This causes misery as the client has to withdraw, go for a period of no meds, then build up a tolerance to the new meds.

Why the consultant US trained psych does not appear to practise the "collegial relationship" with their peers as is required by their registration, in regard to their local experience of locally presribed drugs is beyond me, but may be grounds for a complaint to the Disability Commissioner, if not the Medical Council

For example from the Medical Council website (names deleted):

"Provisional General
Dr X is permitted to practise medicine in the position of Specialist in Psychiatry at ****** under the supervision of Dr Y between 01 December **** and 01 October ****.
The purpose of this registration is to enable Dr X to complete Council's requirements for registration within the general scope."

If they were to carry out that sort of practise in the States, they would face massive mistreatment claims, but it's hard to do in NZ, and they think the patient is uninformed.

Always check your medical providers records with the Medical Council especially if they are from off-shore, and aways research drug interactions and contra-indications.
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#8 User is offline   Shapeshifters 

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Posted 12 March 2008 - 05:02 PM

Sparrow

Ask the doctor if he would ask that of one of his family members,don't think so
Over sea's they pay for that , [ Labs RAT's they call them]
My once Gp told me he tried Tramadol once and would not ever again,as he was writing a script for the exact same thing for me
These people are totally oblivious to the consequences of these medications or have been totally brain washed?.care??
Then if we have problems they roll it onto some other fault of our own
I am not anti the medical establishment totally but they seem to be a power all of their own
With the move towards natural medication and treatments,hopefully things will improve

Medwyn

I have searched the NZ Medical Council's web site and found it lacking information,maybe its me
One would expect detailed and current lnformation,my present Doctor is not listed and his predecessor is still listed at the same practice,is he qualified?
Can you shine any more light on this subject as I would like to ascertain if my Gp is NZ Qualified and al so if a previous shrink or two from a while back were actually qualified at that time [mid 90's]
Please PM me if you can help
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#9 User is offline   Medwyn 

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Posted 12 March 2008 - 07:20 PM

View PostShapeshifters, on Mar 12 2008, 06:02 PM, said:

Medwyn

I have searched the NZ Medical Council's web site and found it lacking information,maybe its me
One would expect detailed and current information, my present Doctor is not listed and his predecessor is still listed at the same practice,is he qualified?
Can you shine any more light on this subject as I would like to ascertain if my Gp is NZ Qualified and al so if a previous shrink or two from a while back were actually qualified at that time [mid 90's]
Please PM me if you can help

I have taken my info from the following link:- http://www.mcnz.org.nz/FindaRegisteredDoct...67/Default.aspx

Have a look at the following PDF file especially the last page in regard to registration: http://www.mcnz.org....ions/health.pdf.

I can only surmise that if a doctor is not listed, they should not practise but that's IMHO.
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#10 User is offline   Not Waddie 

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Posted 12 March 2008 - 07:28 PM

If you do a search make sure that the spelling is correct. If you are unsure you can email the medical council and they will confirm or otherwise. I think they responded to my request within 24 hrs. It would be highly unlikely a GP is not registered but not impossible. Regardless, it pays to have a supportive GP. If you are not happy with the current one then try looking around for another one.

Tramadol is widely used for moderate pain. Although obviously it can affect people differently. If there are unacceptable side effects or it is not working then advise the GP. There will be other alternatives. At the end of the day it is your choice what you put in your mouth or what methods you use to relieve symptoms. All the medical profession can do is give the best advice based on conventional medical knowledge.

I think exercise an important component to most treatment, whether conservative or alternative. 30 minutes a day walking works for me.
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#11 User is offline   Shapeshifters 

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Posted 12 March 2008 - 08:22 PM

Medwyn
Cheers for that link,when I tried earlier search facility would not work



Not Waddie

'Tramadol is widely used for moderate pain. Although obviously it can affect people differently. If there are unacceptable side effects or it is not working then advise the GP. There will be other alternatives. At the end of the day it is your choice what you put in your mouth or what methods you use to relieve symptoms. All the medical profession can do is give the best advice based on conventional medical knowledge. '

Sadly factual evidence is sadly shining a dime light on pharmacueticals and the not so exact science behind them
I also know the reality of having a life of pain 'rock and the hard place scenario'

Yes I find walking structured around my restrictions is great
Problem is we know our body better than anyone ,but the acc needs measurements and other so called scientific data which does not support self management in a way that is totally beneficial to a better quality of life

You give alot of constructive advice on here ,great stuff

Regarding changing your GP unfortuately this is becoming harder in smaller regions as they are have recruiting and retention problems
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#12 User is offline   Sparrow 

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Posted 12 March 2008 - 09:26 PM

Shapie, have you ever tried alternative treatments for your pain?
I find acupuncture marvellous and have had it for 20yrs now , The guy I have now was a Chinese consultant Orthopedic surgeon in his homeland and he can diagnose and treat so well. He does deep tissue therapy which hurts but works very well for me.
I am also into Scenar therapy and this is a magic wand. I carry my small device everywhere and it is beside my bed at night as well. I can use it for 10mins and the pain just melts away. I t is great for acute problems but Chronic problens are hard to treat. However, I know my problem will never go away and I am happy with temporary pain relief!!

There are many websites and all you need to do is google Scenar therapy.
If you are interested, PM me an dI may know of a scenar therapist in your area...!
Good luck and keep off those pills, they can kill you!!!
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#13 User is offline   MINI 

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Posted 13 March 2008 - 09:23 AM

Shapshifters

I would agree with Sparrow and Non Waddie. What we put in our mouths is determined by ourselves, no one else.

I have very high doseage pain killers for real bad episodes of pain. I have used them twice in the past year. I have to take Losec at the same time as they upset my tummy something rotten. So I take them as little as possible.

However I do go to the pool once a week and have exercises, not only for my body but also for my cognitive skills, which is fantastic. I can feel the difference, when for some reason I cannot go. The warm water is fab for your muscles and the exercise clears the head.

For pain I usually just take a couple of panadol and only do what I can for a day or two. No heavy lifting etc. Lie up on the couch and read case law, see what cases may assist me, in what area.

Keepaway from the computor for a while and potter around doing little things that need attention but we always leave till another day. Like polishing waist high furniture etc and watering pot plants. Sometimes standing is easier for me than sitting.

Good Luck
Mini
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#14 User is offline   Shapeshifters 

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Posted 13 March 2008 - 08:49 PM

Parts of the human body are very resilient and can bounce back from the side effects possed by a number of medications
One major problem I had while on a roller coaster ride of pharmaceutical cocktails, was my immune system was pushed to the max
Requiring lots of visits to the GP and expense ,but more importantly exposed me to the elements ???
,

Idiosyncratic drug reactions, also known as type B reactions, are drug reactions which occur rarely and unpredictably amongst the population. This is not to be mistaken with idiopathic which entails that the cause is not known.

Some patients have multiple-drug intolerance. Patients who have multiple idiopathic effects that are nonspecific are more likely to have anxiety and depression.

Idiosyncratic drug reactions appear to not be concentration dependent. A minimal amount of drug will cause an immune response, but it is suspected that at a low enough concentration, a drug will be less likely to initiate an immune response.

In adverse drug reactions involving overdoses, the toxic effect is simply an extension of the pharmacological effect. On the other hand, clinical symptoms of Idiosyncratic drug reactions are different than the pharmacological effect of the drug.

The proposed mechanism of most idiosyncratic drug reactions is immune mediated toxicity. To create an immune response, you must have a foreign molecule that antibodies can bind to (ie. the antigen) and you must have cellular damage. Very often, drugs will not be immunogenic because they are too small to bind antibodies. However, a drug can cause an immune response if the drug binds a larger molecule. Some unaltered drugs such as penicillin will bind avidly to proteins. Others must be bioactivated into a toxic compound that will in turn bind to proteins. The second criteria of cellular damage can come either from a toxic drug/drug metabolite or it may come from an injury or infection. These will sensitize the immune system to the drug and cause a response.
Beware !!!!!
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#15 User is offline   hukildaspida 

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Posted 22 August 2012 - 02:00 AM

Based on the balance of probabilities he may well have become "agitated" because of the way he was been treated,
in fact he may well have just been "assertive" as he is entitled to exercise his Legal Rights under various laws.
Sadly some people in places of health service fail to recognize the difference.
It is an area where there is need for education and improvement of staff skills to determine the difference in such behavior in the health sector.


http://www.nzherald....jectid=10828412

Coroner: Unsafe drug killed patient

By Hayden Donnell
1:36 PM Tuesday Aug 21, 2012


The patient was given a dose of the antipsychotic drug haloperidol. Photo / Thinkstock

A 76-year-old dementia sufferer died after being given a potentially fatal drug by a doctor who did not check his clinical notes, a coroner has found.

Coroner Chris Devonport recommended Canterbury District Health Board
review the availability of sedatives in its hospital wards after the death of David Ian Jackson in Princess Margaret Hospital on July 9 last year.

His finding said Dr Jackson had a medical history of progressive cerebral Lewy body disease causing dementia and Parkinsonism.

He was given a dose of the antipsychotic drug haloperidol when he became aggressive and difficult to control on July 4.

The drug resulted in Dr Jackson contracting Neuroleptic Malignant Syndrome - a condition fatal in 10 to 20 per cent of cases, Coroner Devonport said.

Dr Jackson died within days.

Coroner Devonport said haloperidol can be harmful or even fatal when given to sufferers of Lewy body disease and Parkinsonism.

Duty registrar David Bruce did not check Dr Jackson's clinical notes before giving him an initial dose of the drug, he said.

His finding said Dr Bruce should have briefly checked the notes before deciding on the treatment.

An alternative and safer drug - midazolam - was at the hospital but was not available in Dr Jackson's ward.

"Dr Bruce was aware of the risk to a patient with LBD that haloperidol presented and review of hospital notes by Dr Bruce would have alerted him to the fact that Dr Jackson suffered from [Lewy body disease]."

Security staff were not present when Dr Jackson became agitated.

Coroner Devonport said if security were at the scene, Dr Bruce may have had more time to review hospital records and decide against administering haloperidol.

He recommended Canterbury District Health Board review the availability of sedatives and the provision of security at Princess Margaret Hospital.

The hospital had changed its policies and procedures for dealing with Lewy body disease sufferers as a result of the case.

- APNZ
By Hayden Donnell | Email Hayden
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