Monthly Archives: April 2008

Concern at doping of erratic elderly

The Press (New Zealand)

Concern is growing about the doping of elderly rest home residents with anti-psychotic drugs.

British research shows the practice – soon to be the subject of a New Zealand study – can result in premature death.

Researchers from King’s College in Britain compared the life expectancy of people with dementia and prescribed anti-psychotic medication with those not on the drugs.

They found those given anti-psychotic drugs, not designed to treat dementia but sometimes used to control aggression, died much earlier.

After 24 months on the study, more than 45 per cent of those taking anti-psychotic medication had died compared with 22% of people in the other group.

It is unknown exactly how many elderly New Zealanders with dementia or Alzheimer’s disease are prescribed the psychiatric medications.

However, a group of North Island researchers will soon publish a study looking at the use of anti-psychotic medication in rest homes.

Old-age psychiatrist Matthew Croucher said far too many elderly were likely to be prescribed anti-psychotic drugs unnecessarily.

The drugs made them more likely to fall over and hurt themselves, have a stroke and in some cases die prematurely, while the benefits were modest, he said.

“Overseas there is an increasing concern about the use of anti-psychotics among the elderly. In the UK inappropriate over-medication is widespread,” he said. “Here we are now looking at the issue because it is a significant one.”

Croucher is one of a team of people recently charged by New Zealand’s drug agency, Pharmac, to write prescription guidelines for anti-psychotic use in rest homes. He was also reviewing the North Island research.

Age Concern Canterbury chief executive Andrew Dickerson said he was disturbed by the British study, which was done by credible university academics.

He considered it abuse for people to be inappropriately medicated in rest homes, particularly if it happened because of staff shortages.

People with dementia could sometimes be difficult and required high levels of care but over-sedating them was not an appropriate response, he said.

Alzheimers New Zealand national director Lucille Ogston said it was sometimes appropriate to use anti-psychotic drugs to control intense physical or behavioural issues in people with dementia or Alzheimer’s disease.

However, this was generally appropriate only in small doses and over short periods of time.

Staff shortages in rest homes and a lack of properly trained carers meant doctors were sometimes put under pressure to prescribe anti-psychotic drugs to control or sedate elderly, Ogston said.

She and Dickerson welcomed Pharmac’s decision to write guidelines on the use of anti-psychotic drugs as a first step to understanding the scale of the problem in New Zealand.

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Stop drugging dementia patients, urges report

Telegraph

Ministers should step in to stop inappropriate prescriptions of powerful antipsychotic drugs for Alzheimer’s patients, an influential group of MPs [Members of Parliament] said today.

Up to 105,000 people with dementia in Britain are wrongly being treated with the drugs, which are used to control behavioural symptoms such as aggression, they claim. Research has shown that the medications have side effects which can accelerate mental decline, triple the risk of stroke, and double the chances of premature death.

They are intended for psychotic patients suffering from delusions, paranoia and hallucinations. Yet the drugs continue to be used as a first resort to address the challenging behaviour of people suffering from Alzheimer’s disease and other types of dementia, according to the MPs. A report from the all-party parliamentary group (APPG) on dementia demanded Government action on the problem and urged the National Institute for Health and Clinical Excellence (Nice), the health watchdog, to carry out a review.

The report, A Last Resort, points out that no audit or regulation of such prescriptions exists. Jeremy Wright, the group’s chairman, said: “Antipsychotics can double risk of death and triple the risk of stroke in people with dementia, (can) heavily sedate them, and (can) accelerate cognitive decline.

“The Government must end this needless abuse. Safeguards must be put in place to ensure antipsychotics are always a last resort. We need to include families in decisions, give people with dementia regular reviews, and equip care staff with specialist training.”

The inquiry was told that 150,000 people with dementia were prescribed antipsychotic drugs in British care facilities. Psychiatric experts said 70 per cent of these prescriptions were inappropriate.

Neil Hunt, the chief executive of the Alzheimer’s Society, said more than 70 per cent of dementia patients exhibited challenging behaviour.

“More often than not this is an expression of unmet need, not a symptom of dementia, and there is no excuse for reaching for the medicine cabinet,” he said.

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Members of Parliament urge cut in dementia drug use

BBC News

MPs have urged the government to stop the “dangerous over-prescribing” of antipsychotic drugs to people in care homes with dementia.

The All Party Parliamentary Group on Dementia said the drugs should only be used as a last resort.

Research published earlier this month said the drugs had no benefits, and could even worsen patients’ condition.

Alzheimer’s groups said safeguards should be introduced to ensure the drugs were used only when essential.

There are currently 700,000 people with dementia in the UK, but that figure is predicted to soar to well over 1.7m by 2051.

The recent study, by experts from Kings College London and Oxford and Newcastle Universities, found the drugs provided no benefit for patients with mild behavioural problems, but were associated with a significant deterioration in verbal skills.

Side effects previously cited include excessive sedation, dizziness social withdrawal, accelerated cognitive decline and severe sensitivity reactions.

There have also been suggestions that use of two of the drugs, risperidone and olanzapine, can increase the risk of stroke.

Five-point plan

The committee looked at the prescription of antipsychotics to care home residents.

It concluded that around 70% of prescriptions are inappropriate, equating to around 105,000 people with dementia.

People also often stayed on the medication for far longer than was necessary, it concluded.

The MPs propose a five-point plan to address the issue for inclusion in the government’s National Dementia Strategy, due to be published later this year.

Specialist dementia training for all care home staff

Families to be involved in all decisions about giving the drugs

More support for care home staff from GPs, psychiatrists and psychiatric nurses

Compulsory patient reviews every 12 weeks

A cost-effectiveness review by NICE, the National Institute of Health and Clinical Excellence and a national audit by the Care Quality Commission, which supervises care homes

Jeremy Wright MP, chairman of the group, said: “The government must end this needless abuse and make the five-point-plan a key element of the strategy.

“Safeguards must be put in place to ensure antipsychotics are always a last resort.”

He added: “We need to include families in decisions, give people with dementia regular reviews and equip care staff with specialist training.”

‘Deteriorated rapidly’

One carer said the home where his wife resided sent for him because she had deteriorated rapidly

“We eventually got the GP out and he admitted that he did not know what to do.

“He suggested that he should ask the consultant to visit and see what he could do to help my wife. It took five months to get him to visit the home by which time my wife’s health deteriorated.

“When he saw what medication she was on he immediately arranged to have her taken off all antipsychotic drugs.”

‘Serious concerns’

Alzheimer’s experts said more than 70% of people with dementia displayed some form of challenging behaviour at some point, but that it was often a way of expressing themselves, and so they should not automatically be offered drugs.

Neil Hunt, chief executive of the Alzheimer’s Society, said: “It is absolutely disgraceful that widespread abuse of people with dementia has been allowed to continue despite safety warnings on antipsychotics. Urgent action is needed.”

Rebecca Wood, chief executive of the Alzheimer’s Research Trust, added: “The report highlights the urgent need to develop better treatments for Alzheimer’s.

“With more research funding, we could produce better drugs that are fit for purpose.”

Ivan Lewis, care services minister, said: “The All-Party report raises issues of serious concern. Inappropriate administration of medication is entirely unacceptable.

“Guidance to health professionals and care staff is very clear, antipsychotic drugs should only be used when they are appropriate as part of best clinical care practice.”

He said the dementia strategy would address the issue of medication and seek to protect people with dementia from poor professional practice.

The drugs concerned are haloperidol [haldol], chlorpromazine [thorazine], risperidone [risperdal], olanzapine [zyprexa], quetiapine [seroquel] and amisulpiride [solian].

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New Jersey’s Attorney General And Antipsychotics

Pharmalot.com

By Ed Silverman

Earlier this year, we noted that New Jersey’s Medicaid program spent more than $73 million on several antipsychotic meds for children less than 18 years old between 2000 and 2007, according to state records, even though the drugs weren’t approved by the FDA for treating kids. And a state official acknowledges the drugs may have been prescribed for conditions other than schizophrenia and bipolar disorder, the approved uses.

And so a state legislator wrote New Jersey Attorney General Anne Milgram calling for an investigation. In his letter, Pat Diegnan, an assemblyman who has previously been outspoken about the use of these meds, asked Milgram to pursue an investigation of the “alleged misrepresentations concerning the safety and effectiveness of antipscychotic drugs,” which he first requested more than a year ago of her predecessor.

In an April 1 reply, Milgram writes back that New Jersey is part of a multi-state working group investigating the marketing of Lilly’s Zyprexa. To be specific, about 30 states are looking into the controversy over off-label promotion and the extent to which side effects, such as diabetes and weight gain, were hidden. But Milgram doesn’t mention any other drugmaker or their antipsychotics in her response. Does this mean the AG isn’t looking at the issue? Or simply doesn’t want to tip her hand? A spokesman declined to comment.

“Please be assured that this office remains committed to taking action appropriate when we learn of allegations of misrepresentations related to the safety and effectiveness of pharmaceuticals,” Milgram wrote. To date, Milgram has created a task force to examine the interplay between drugmakers and docs, and has subpoeaned Merck, Schering-Plough and Amgen over marketing various meds.

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UC to keep closer eye on prof’s income

Cincinnati Enquirer

BY CLIFF PEALE

The University of Cincinnati will increase scrutiny on a psychiatry professor for not reporting all of the hundreds of thousands of dollars in corporate research money she received from a pharmaceutical giant during the last decade.

Melissa DelBello now has to review all of of her interactions with companies with her department chairman, UC vice president of research Sandra Degen said Friday.

DelBello’s teaching and research haven’t been restricted, but the fact that she didn’t tell the university about some of her outside income has been detailed in her personnel file.
“It’s to protect her,” Degen said. “Basically, we were documenting that there were some discrepancies in what was reported.”

DelBello became the focus of controversy after U.S. Sen. Charles Grassley, R-Iowa, criticized her and UC as examples of a system he called rife with conflicts of interest that compromise drug research.

Grassley said DelBello received more than $100,000 from AstraZeneca in 2003, the year after she led a study of the company’s drug Seroquel, meant to treat bipolar disorder in children. She reported that income to UC. The study was inconclusive but reported some patients benefited from the treatment.

From 2005 to 2007, DelBello reported about $100,000 in outside income to UC, but AstraZeneca told Grassley it paid her more than $238,000.

He has proposed a bill to require drug companies to disclose all of the money they give researchers.

He also criticized a company DelBello started, called MSZ Associates, that also received AstraZeneca money, something she did not tell UC.

DelBello declined to answer questions about her research funding or Grassley’s criticism.

Degen said there is no evidence that the money had any impact on the substance of the research.

Grassley requested hundreds of pages of documents from UC about DelBello’s research, bringing national attention to the issue of university professors soliciting corporate funds to support research that might involve the companies providing the money.

Last year, UC researchers received $8.7 million from companies, and $178.1 million from the federal government. With federal support stagnant, the university is encouraging professors to solicit corporate funds and start companies so they can pay for their research.

“It’s a well-accepted fact that (companies) go out to the world’s experts to study diseases with no strings attached,” Degen said. “The main point is how the perceived conflict of interest is disclosed. As long as you disclose it, then it’s fine.”

UC now prohibits gifts from drug companies and forbids industry representatives from being on campus without a specific appointment.

Degen said the change was in planning before Grassley’s requests.

Grassley said the payments and perception of a conflict of interest “is unfortunate on many levels.” It is unfortunate for the University of Cincinnati that relied on the representations of its faculty,” he said. “It is unfortunate for patients who once believed that their doctor was not for sale.”

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‘Lethal’ drugs given for dementia

The Sunday Times

By Claire Newell and Steven Swinford

WHEN David Ramsay, a former senior consultant at Guy’s hospital in London, was diagnosed with dementia in 1998, his wife fought for three years to have him taken into full-time care.

But just months after winning her battle, David’s neck twisted by 90 degrees, leaving his chin permanently fixed to his chest and forcing him to spend the rest of his life staring at the ground.

His condition, a rare neurological disorder, was a side-effect of a powerful antipsychotic drug prescribed to control the symptoms of Alzheimer’s. According to a parliamentary report, to be published later this month, his case is far from isolated.

The report, by the all party parliamentary group on dementia, has found that elderly people are routinely being prescribed antipsychotic drugs to make the lives of carers easier, despite evidence that they are of little benefit to the patient and have potentially lethal side effects.

Jeremy Wright MP, the Conservative chairman of the group, said: “It is clear that there are many occasions when these drugs are being used as a method of chemical restraint. This is undoubtedly systematic abuse.”

The Alzheimer’s Society estimates that antipsychotic drugs are being prescribed to 105,000 elderly people with dementia in Britain, and that in two-thirds of cases the drugs are unnecessary. Studies show they can increase the risk of strokes and have other side effects, such as the disorder suffered by Ramsay.

According to his family, Ramsay was given Olanzapine (Zyprexa) in October 2001 without their knowledge. When he refused to take the drug his carers allegedly ground the pills into powder to put in his yoghurt. He developed tardive dystonia, which twisted his neck, in April 2002.

Ramsay was taken off the drugs and moved to a specialist nursing home, where he died in September 2006, aged 63. At his funeral in St Mary’s Church in Chislehurst, Kent, mourners were presented with two images of David, one as a healthy 50-year-old, looking proudly ahead, the other with his head twisted at a 90-degree angle.

Lynne, his wife, said: “I wanted everyone to appreciate how people with dementia are treated and the massive impact these drugs had on David’s life.”

The all party report will recommend improved training for carers, better consultation for family and friends and a three-monthly review of medication for care home residents.

A spokesman for the Oxleas Foundation NHS Trust, which prescribed Ramsay the antipsychotic drug, said Ramsay knowingly agreed to take Olanzapine. The trust claims the drug improved his mental health, and added that the medication had been approved by a clinical director from another NHS trust.

Eli-Lilly, the manufacturer of Olanzapine, said the side effect suffered by Ramsay was “very rare” and the drug was neither licensed nor promoted in the UK to treat patients with dementia.

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Antipsychotic Drugs Increase Risk Of Developing Pneumonia In Elderly, Study Suggests

ScienceDaily

Elderly patients who use antipsychotic drugs have a 60 percent increased risk of developing pneumonia compared to non-users. This risk is highest in the first week following prescription and decreases gradually thereafter. Antipsychotic drugs are frequently used in elderly patients for the treatment of psychosis and behavioral problems associated with dementia and delirium. This study is the first to show that the development of pneumonia is associated with antipsychotic drug use.

“The risk of developing pneumonia is not associated with long-term use, but is the highest shortly after starting the drug,” say Drs. Rob van Marum and Wilma Knol, authors of the study. They caution that “all antipsychotic drugs may be associated with pneumonia in elderly patients.”

In nursing homes, up to 40 percent of residents may be prescribed antipsychotics, according to the study. It has been suggested that, for residents of nursing homes who receive antipsychotic therapy, more than half are prescribed for inappropriate reasons.

Although literature shows limited efficacy and effectiveness for antipsychotic drug use in the treatment of behavioral problems in dementia patients, these drugs are frequently used for this purpose. In the last few years it has become clear that the use of antipsychotic drugs in elderly patients is also associated with an increased risk of death and morbidity…

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