Drug maker knew 30 years ago of possible link to suicide

Drug maker knew 30 years ago of possible link to suicide

Joined: April 1st, 2004, 4:56 pm

April 6th, 2009, 3:39 pm #1

Revealed: the danger of taking Prozac
Drug maker knew 20 years ago of possible link to suicide

 

http://www.guardian.co.uk/uk/1999/sep/04/sarahboseley Prozac, the anti-depressant taken by millions, was known by its manufacturers as a possible cause of agitation leading to suicidal tendencies as long ago as 1978, according to documents released in the US civil courts.
Internal documents which appear to suggest Eli Lilly, manufacturer of Prozac, knew 20 years ago there could be a problem, may be relevant to the first British case concerning the drug, now heading for the courts.

Reginald Payne, 63,a teacher from Wadebridge, Cornwall, suffocated his wife and threw himself off a cliff in March 1996. He had been taking Prozac for just 11 days. His family blames the drug and has issued court proceedings against the manufacturers.

The Eli Lilly papers, which chronicle the company's concerns over the restless state of mind of some patients during clinical trials, were produced during a case in Hawaii, the first of some 200 in the US alleging links between Prozac, violence and suicide, to have come to a verdict.

The case concerned a couple who retired to Hawaii from California in 1989. Finding it hard to adjust to the changes in his life, Bill Forsyth saw a doctor and was prescribed Prozac for a mixed depressive anxiety disorder. At first Mr Forsyth said he felt marvellous, but within two days he was imploring his son and wife to get him into a psychiatric hospital. Soon after he returned home, he stabbed his wife June to death and impaled himself on a kitchen knife.

Evidence of violence

The family's lawyers argued in court that Eli Lilly had known for years that patients on Prozac, which was launched in 1988, could suddenly become akathisic - a strange, restless and agitated state of mind in which they can get compulsions to commit violence on other people and themselves.

The lawyers argued that Eli Lilly should be held responsible for failing to warn doctors that some patients might respond in this way and become a danger to others and themselves. Prozac is still a useful and appropriate drug for some patients, they say, but those who take it must be closely watched for the signs of akathisia in the first couple of weeks after beginning a course.

They cited internal minutes from the Prozac development team in August 1978 which ran: "There have been a fairly large number of reports of adverse reactions... Another depressed patient developed psychosis... Akathisia and restlessness were reported in some patients."

The authorities in Germany, considering Eli Lilly's application for a licence in 1984, were concerned. "During the treatment with the preparation [Prozac], 16 suicide attempts were made, two of these with success. As patients with a risk of suicide were excluded from the studies, it is probable this high proportion can be attributed to an action of the preparation." Prozac now carries a warning in Germany of a risk of suicide. "Therefore for his/her own safety, the patient must be sufficiently observed until the antidepressive effect of Fluctin [Prozac] sets in." It adds that the patient may need an additional sedative in the meantime.

The Hawaii family lost its case, but their counsel, Andy Vickery, said they would be appealing on a number of grounds, one of which was the judge's refusal to allow the jury to be told of the German warning. He said: "I was shocked and disappointed to lose. In my final argument, I told the jury their verdict could save lives."

Warning rejected

Graham Ross, a personal injury lawyer based in Neston, Wirrall, who has a number of cases of alleged Prozac-induced suicide on his books, said he takes issue with Eli Lilly because of its failure to warn of the risks to some, not by any means all, patients. "It is their refusal to accept that this is at all possible in any patient, and their insistence that it would have happened anyway that is dangerous and irresponsible, in my view. All we are asking them to do is be more frank in what they say to the medical profession in the first place."

Eli Lilly's spokesmen in the UK and in company headquarters in Indianapolis insist that the Food and Drug Administration (FDA) which licenses medicines in the US, and the Committee on the Safety of Medicines in the UK, had specifically cleared Prozac of inducing suicide in the early 1990s. "That is more important than an attorney's selective manipulation of data," said a US spokesman. "You have to take a look at the patient population. In people with depression there is probably a 15% suicide rate. There is no evidence that Prozac causes suicide."

But although depression is linked to suicide, the rates are highest among those who have been hospitalised, not among those coping in the community who may be prescribed Prozac by their GP and some of whom are anxious rather than depressed.

According to data presented by David Healy, director of the North Wales Department of Psychological Medicine and author of The Antidepressant Era, at the British Association for Psychopharmacology annual meeting in Harrogate in July, the only figures on rates of suicide among depressed people in the UK taking Prozac are six times higher than the probable suicide rates for community depression in the UK, which, he says, "strongly suggests that Prozac may indeed be inducing suicide."
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Joined: April 1st, 2004, 4:56 pm

April 6th, 2009, 3:41 pm #2

The Paynes expected a peaceful retirement. It ended in violent death. But was Prozac to blame?


By Robert Verkaik, Legal Affairs Correspondent


Monday, 4 December 2000

 

http://www.independent.co.uk/life-style ... 26564.html



It was supposed to have been a happy retirement. After the pressures of life as a teacher, Reginald Payne was planning to enjoy his twilight years with Sally, his wife, at their home in Cornwall.



It was supposed to have been a happy retirement. After the pressures of life as a teacher, Reginald Payne was planning to enjoy his twilight years with Sally, his wife, at their home in Cornwall.

There were some problems - Mr Payne had developed the kind of depression common to people who retire after a busy career - but nothing to alarm his family too much.

But then the 63-year-old was prescribed Prozac and everything changed. Within 11 days he had suffocated Mrs Payne, 66, and thrown himself off a cliff near their home in Wadebridge.

The deaths shattered the Paynes' three sons, who said their father had never before shown signs of violence or aggression, but the implications of the tragedy could go far wider than the Payne family. Because, for the first time, a British court is to hear claims that the drug taken by 500,000 Britons can turn rational individuals into dangerous killers.

Lawyers for the Payne sons will go to the High Court next year to try to prove that the drug is to blame for the deaths of their mother and father. It will be the first attempt in Britain to link the world's most popular anti-depressant to violent behaviour and, if successful, it could open the floodgates for hundreds of other families who believe Prozac played a role in the deaths of loved ones.

The family claims that the pharmaceutical giant Eli Lilly, which manufactures the drug, was negligent in failing to warn Mr Payne of the risk of side-effects, which are said to include suicide, violent behaviour, violent and aggressive thoughts, and homicidal tendencies.

Four days after taking his first 20mg of Prozac the sons say their father was subdued. The next week his symptoms worsened when he became increasingly quiet and his behaviour became more unusual. Then, on 15 March 1996, they were told the terrible news of their parents' deaths.

Lawyers acting for the family are to use evidence of a remarkably similar tragedy in America in their claim. In 1993 in Hawaii, William Forsyth fatally stabbed his wife of 37 years in their home. He then leaned against a knife and killed himself.

Mr Forsyth had also been taking Prozac for depression for 10 days before the incident. His children also believe the anti-depressant induced violence that was totally out of character for their father.

Graham Ross, the Liverpool solicitor representing the Paynes, is working closely with the US attorneys who are fighting the Forsyth case on appeal. Although the Hawaii case was lost earlier this year the Payne family will be relying on certain admissions made by Eli Lilly in the course of US litigation.

Of particular interest, according to Mr Ross, are a number of memos which were disclosed during the case. Mr Ross claims that one appeared to highlight the potentially devastating commercial impact on Prozac if a link to suicide and violence was proven when it was launched in Britain. "Lilly can go down the tubes if we lose Prozac, and just one event in the UK can cost us that," it said.

Prozac was launched as an anti-depressant in 1986. It was made available in the US in 1987, and in Britain in 1988. It is now marketed in 99 countries and is the world's most widely prescribed anti-depressant. More than 38 million people worldwide have used Prozac.

As well as the memos, Mr Ross claims the trial documents contain the evidence in court from Eli Lilly's own expert witness admitting that Prozac can cause akathisia - a state of mind that is acknowledged in dozens of published medical papers to be capable of causing acts of violence.

Mr Ross said he would also be using new research carried out by an eminent British medical expert, Dr David Healy,who will be called as a witness.

Dr Healy's findings, published in the journal Primary Care Psychiatry last May, backed up some of the most disturbing claims of some former Prozac users. He found that two out of 20 healthy volunteers put on an anti-depressant in the Prozac group became dangerously suicidal, compared with none when they were put on an anti-depressant from a different drug group. His special report for the Payne case concludes that "this tragedy would not have occurred but for the ingestion of Prozac".

Other studies, too, have raised questions about Prozac rendering depressed people suicidal. In 1995, Herschel Jick, a Boston-based scientist, carried out a study of suicides in the UK among people who had been taking anti-depressants.

He found that in a study of 10 anti-depressants, Prozac topped the list for suicides. Per 100,000 patients on the drug, he established that an average of 187 each year would kill themselves. The normal rate among depressed people is 30 per 100,000, according to the study.

But Eli Lilly has denied the allegations vigorously. In the Hawaii case the company dismissed such studies as "junk science". It has consistently resisted any attempt to link Prozac with suicide or violent behaviour.

In the Forsyth case, attorneys for Eli Lilly argued that Mr Forsyth fitted the typical description of an older person who kills his wife, then himself, because of marital problems and severe depression. Yesterday, a spokesman for the company said it could not comment on "ongoing proceedings".

The Paynes allege that Prozac deprived Reginald Payne of the opportunity of recognising dangerous side-effects and of immediately seeking medical assistance. They argue he suffered pain and injury before his death and are seeking damages for the bereavement. They are also seeking more than £10,000 for the cost of the funeral and probate and solicitors' fees.

Last year, a coroner called for Prozac packets to be issued with warnings, after the suicide of a farmer in Wales two days after he started taking the drug.

John Owen, the South Wales coroner, called for more detailed labelling of the drug during the inquest into the death of Richard Wood, 46, a farmer from Llanboidy, Dyfed.

Mr Wood became suicidal after being prescribed Prozac for depression. Eventually, he shot himself in the head with his .22 rifle. His wife, Sally, said he "spiralled downhill" after he began taking the pills in February 1998. "He got very frightened and agitated," she said. "He complained that there was a black cloud over him and all he wanted to do was get out of it."

Mr Ross said: "It is now becoming fairly clearly accepted, outside of the manufacturers and their PR agencies, that Prozac can, in some patients who have not been closely monitored by their doctors, produce a condition of mind that can lead to acts of violence that would not otherwise have occurred.

"Although this effect may only be seen in a small percentage of such patients, the damage can be so devastating that there is no question but that the manufacturers owe doctors and patients a much more frank acknowledgement of these risks and a less robust defence of their commercial interests. Our case is based on the claim that they have had this knowledge at all times but have not satisfied their legal obligations to impart that knowledge to doctors and patients."

If the court agrees, the families of suicide victims may turn on Eli Lilly in their hundreds. If that happens, the company could indeed be facing a future down the tubes.
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Joined: April 1st, 2004, 4:56 pm

April 6th, 2009, 3:55 pm #4


<strong>Prozac made our father kill our mother then himself</strong>

Mail on Sunday Nov 30 1997

THE family of a man who murdered his wife then killed himself after taking Prozac is poised to sue the drugs makers.

Experts hope to prove the tragedy was caused by the drug in what could be the first case of its kind to reach a British court.

Reginald Payne threw himself from a cliff near his home in Wade-bridge, Cornwall, after suffocating his wife Sally, 66, in March last

The 63-year-old retired teacher had started a course of Prozac for depression 11 days earlier.

Richard Payne, the eldest of the couples four sons, said: According to experts the danger period for behaviour problems is the first two weeks someone is on the drug. It seems too much of a coincidence for Prozac not to be involved.

Prozac, hailed as the sunshine drug, is taken by 15 million people worldwide 500,000 of them in Britain.

Many celebrities have resorted to it including rock star Michael Hutchence, found hanged in a hotel room in Sydney a week ago.

Critics say the drug can cause aggressive and suicidal behaviour.

Mr Payne,39, a management consultant, said: My parents were happily married and there had been no indication that my father would take his life.

The family is represented by Graham Ross, a solicitor specialising in medical cases, who has been investigating the side-effects of Prozac. He said: The fact that the manufacturers list suicidal tendencies and violent behaviour as possible adverse effects is so significant that doctors need to be warned.

Their claim that no causal relationship has been established is disputed.

He added: The allegation is that it causes akathisia racing confusion of thoughts and actions which induces violence towards oneself and others.

Duncan Murchison, who runs the Prozac Survivors Support Group, claimed last night that he had received dozens of calls from people on Prozac who have suicidal or homicidal feelings.

A spokeswoman for the drugs manufacturers, Eli Lilly, said:

Scientific evidence has demonstrated no causal link between Prozac and aggressive behaviour.
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Joined: April 1st, 2004, 4:56 pm

April 6th, 2009, 3:59 pm #5

Revealed: the danger of taking Prozac
Drug maker knew 20 years ago of possible link to suicide

 

http://www.guardian.co.uk/uk/1999/sep/04/sarahboseley Prozac, the anti-depressant taken by millions, was known by its manufacturers as a possible cause of agitation leading to suicidal tendencies as long ago as 1978, according to documents released in the US civil courts.
Internal documents which appear to suggest Eli Lilly, manufacturer of Prozac, knew 20 years ago there could be a problem, may be relevant to the first British case concerning the drug, now heading for the courts.

Reginald Payne, 63,a teacher from Wadebridge, Cornwall, suffocated his wife and threw himself off a cliff in March 1996. He had been taking Prozac for just 11 days. His family blames the drug and has issued court proceedings against the manufacturers.

The Eli Lilly papers, which chronicle the company's concerns over the restless state of mind of some patients during clinical trials, were produced during a case in Hawaii, the first of some 200 in the US alleging links between Prozac, violence and suicide, to have come to a verdict.

The case concerned a couple who retired to Hawaii from California in 1989. Finding it hard to adjust to the changes in his life, Bill Forsyth saw a doctor and was prescribed Prozac for a mixed depressive anxiety disorder. At first Mr Forsyth said he felt marvellous, but within two days he was imploring his son and wife to get him into a psychiatric hospital. Soon after he returned home, he stabbed his wife June to death and impaled himself on a kitchen knife.

Evidence of violence

The family's lawyers argued in court that Eli Lilly had known for years that patients on Prozac, which was launched in 1988, could suddenly become akathisic - a strange, restless and agitated state of mind in which they can get compulsions to commit violence on other people and themselves.

The lawyers argued that Eli Lilly should be held responsible for failing to warn doctors that some patients might respond in this way and become a danger to others and themselves. Prozac is still a useful and appropriate drug for some patients, they say, but those who take it must be closely watched for the signs of akathisia in the first couple of weeks after beginning a course.

They cited internal minutes from the Prozac development team in August 1978 which ran: "There have been a fairly large number of reports of adverse reactions... Another depressed patient developed psychosis... Akathisia and restlessness were reported in some patients."

The authorities in Germany, considering Eli Lilly's application for a licence in 1984, were concerned. "During the treatment with the preparation [Prozac], 16 suicide attempts were made, two of these with success. As patients with a risk of suicide were excluded from the studies, it is probable this high proportion can be attributed to an action of the preparation." Prozac now carries a warning in Germany of a risk of suicide. "Therefore for his/her own safety, the patient must be sufficiently observed until the antidepressive effect of Fluctin [Prozac] sets in." It adds that the patient may need an additional sedative in the meantime.

The Hawaii family lost its case, but their counsel, Andy Vickery, said they would be appealing on a number of grounds, one of which was the judge's refusal to allow the jury to be told of the German warning. He said: "I was shocked and disappointed to lose. In my final argument, I told the jury their verdict could save lives."

Warning rejected

Graham Ross, a personal injury lawyer based in Neston, Wirrall, who has a number of cases of alleged Prozac-induced suicide on his books, said he takes issue with Eli Lilly because of its failure to warn of the risks to some, not by any means all, patients. "It is their refusal to accept that this is at all possible in any patient, and their insistence that it would have happened anyway that is dangerous and irresponsible, in my view. All we are asking them to do is be more frank in what they say to the medical profession in the first place."

Eli Lilly's spokesmen in the UK and in company headquarters in Indianapolis insist that the Food and Drug Administration (FDA) which licenses medicines in the US, and the Committee on the Safety of Medicines in the UK, had specifically cleared Prozac of inducing suicide in the early 1990s. "That is more important than an attorney's selective manipulation of data," said a US spokesman. "You have to take a look at the patient population. In people with depression there is probably a 15% suicide rate. There is no evidence that Prozac causes suicide."

But although depression is linked to suicide, the rates are highest among those who have been hospitalised, not among those coping in the community who may be prescribed Prozac by their GP and some of whom are anxious rather than depressed.

According to data presented by David Healy, director of the North Wales Department of Psychological Medicine and author of The Antidepressant Era, at the British Association for Psychopharmacology annual meeting in Harrogate in July, the only figures on rates of suicide among depressed people in the UK taking Prozac are six times higher than the probable suicide rates for community depression in the UK, which, he says, "strongly suggests that Prozac may indeed be inducing suicide."
In children, fluoxetine is not licensed or recommended for uses other than moderate to severe depression. Children and adolescents may be more susceptible to hostility and suicidal thoughts or behaviour when starting treatment with antidepressants. They should be carefully monitored and encouraged to report any distressing feelings, thoughts about suicide or self-harm, irritability, mood changes or other unusual change in behaviour that they may experience while taking the medicine. If you are worried about your child at any point it is important to talk to your doctor immediately. There is only limited evidence available concerning the long-term safety of fluoxetine in children and adolescents, in terms of its effect on growth (height and weight) and sexual, cognitive, emotional and behavioural development. Your doctor should carefully discuss the risks and benefits of the medicine with you and your child before treatment is started. The child's growth and development should be monitored during and after treatment. If there is no obvious benefit on the child's depression after nine weeks of treatment, use of the medicine should be reconsidered.http://www.netdoctor.co.uk/medicines/100002193.html
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Joined: April 1st, 2004, 4:56 pm

April 6th, 2009, 5:14 pm #6

why does a corrupt MHRA approve such crap ?
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