Risperdal and other dimentia drugs fail

Ramona Lamascola thought she was losing her 88-year-old mother to dementia. Instead, she was losing her to overmedication. Last fall her mother, Theresa Lamascola, of the Bronx, suffering from anxiety and confusion, was put on the antipsychotic drug Risperdal. When she had trouble walking, her daughter took her to another doctor — the younger Ms. Lamascola’s own physician — who found that she had unrecognized hypothyroidism, a disorder that can contribute to dementia.

Theresa Lamascola was moved to a nursing home to get these problems under control. But things only got worse. “My mother was screaming and out of it, drooling on herself and twitching,” said Ms. Lamascola, a pediatric nurse. The psychiatrist in the nursing home stopped the Risperdal, which can cause twitching and vocal tics, and prescribed a sedative and two other antipsychotics.

“I knew the drugs were doing this to her,” her daughter said. “I told him to stop the medications and stay away from Mom.”

Not until yet another doctor took Mrs. Lamascola off the drugs did she begin to improve.

The use of antipsychotic drugs to tamp down the agitation, combative behavior and outbursts of dementia patients has soared, especially in the elderly. Sales of newer antipsychotics like Risperdal, Seroquel and Zyprexa totaled $13.1 billion in 2007, up from $4 billion in 2000, according to IMS Health, a health care information company. Part of this increase can be traced to prescriptions in nursing homes. Researchers estimate that about a third of all nursing home patients have been given antipsychotic drugs. The increases continue despite a drumbeat of bad publicity. A 2006 study of Alzheimer’s patients found that for most patients, antipsychotics provided no significant improvement over placebos in treating aggression and delusions.

In 2005, the Food and Drug Administration ordered that the newer drugs carry a “black box” label warning of an increased risk of death. Last week, the F.D.A. required a similar warning on the labels of older antipsychotics. The agency has not approved marketing of these drugs for older people with dementia, but they are commonly prescribed to these patients “off label.” Several states are suing the top sellers of antipsychotics on charges of false and misleading marketing.

Ambre Morley, a spokeswoman for Janssen, the division of Johnson & Johnson that manufactures Risperdal, would not comment on the suits, but said: “As with any medication, the prescribing of a medication is up to a physician. We only promote our products for F.D.A.-approved indications.”

Nevertheless, many doctors say misuse of the drugs is widespread. “These antipsychotics can be overused and abused,” said Dr. Johnny Matson, a professor of psychology at Louisiana State University. “And there’s a lot of abuse going on in a lot of these places.”

Dr. William D. Smucker, a member of the American Medical Directors Association, a group of health professionals who work in nursing homes, agreed. Though the group encourages doctors to conduct a thorough assessment and prescribe antipsychotics only as a last resort, he said, “Many physicians are absent without leave in the nursing home and don’t take an active role in the assessment of the patient.”

Some nursing homes are trying a different approach, so-called environmental intervention. The strategies include reducing boredom, providing intellectual and physical stimulation, exercise, calming music, bringing in pets for therapy and improving how the staff approaches and talks to dementia patients.

At the Margaret Teitz Nursing and Rehabilitation Center in Queens, social workers do life reviews of patients to understand their interests, lifestyle and former occupations.

“I had a patient who used to be in fashion,” said Nancy Goldwasser, the director of social services. “So we got her fabric samples. And she’d sit and look through the books, touch the fabric, and it would calm her.”

But such approaches are time consuming, they do not help all patients, they can be prohibitively expensive and they will be more difficult to provide as Alzheimer’s continues to increase.

“Our health care system isn’t set up to address the mental, emotional and behavioral problems of the elderly,” said Dr. Gary S. Moak, president of the American Association for Geriatric Psychiatry.

Nursing homes are short staffed, and insurers do not generally pay for the attentive medical care and hands-on psychosocial therapy that advocates recommend. It is much easier to use sedatives and antipsychotics, despite their side effects.

The first generation of antipsychotics, like Haldol, carry a significant risk of repetitive movement disorders and sedation. Second-generation antipsychotics, also called atypicals, are more commonly prescribed because the risk of movement disorders is lower. But they, too, can cause sedation, and they contribute to weight gain and diabetes. Used correctly, the drugs do have a role in treating some seriously demented patients, who may be incapacitated by paranoia or are self-destructive or violent. Taking the edge off the behavior can keep them safe and living at home, rather than in a nursing home.

If patients are prescribed an antipsychotic, it should be a very low dose for the shortest period necessary, said Dr. Dillip V. Jeste, a professor of psychiatry and neuroscience at the University of California, San Diego. It may take a few weeks or months to control behavior. In many cases, the patient can then be weaned off of the drugs or kept at a very low dose.

Some experts say another group of medications — antidementia drugs like Aricept, Exelon and Namenda — are underused. Research shows that 10 to 20 percent of Alzheimer’s patients had noticeable positive responses to the drugs,* and 40 percent more showed some cognitive improvement, even if it was not noticeable to an observer.

“Sometimes, it’s enough to take the edge off the behavioral problems, so the family and patient can live with it and you don’t expose people to much risk,” said Dr. Gary J. Kennedy, director of geriatric psychiatry at the Montefiore Medical Center in the Bronx.

Other experts cite a lack of research backing these drugs for behavioral problems. If patients begin showing behavioral symptoms of dementia, doctors said, they should have complete medical and psychiatric workups first, especially if symptoms develop suddenly. “Just because someone is 95 does not mean one should not do a workup, especially if she’s been healthy,” Dr. Kennedy said.

Common causes of the symptoms include ministrokes, reparable brain hemorrhage from a mild bump on the head, hypothyroidism, dehydration, malnourishment, depression and sleep disorders.

Some doctors point out that simply paying attention to a nursing home patient can ease dementia symptoms. They note that in randomized trials of antipsychotic drugs for dementia, 30 to 60 percent of patients in the placebo groups improved. (That is much better than the 10% on medications—jk)

“That’s mind boggling,” Dr. Jeste said. “These severely demented patients are not responding to the power of suggestion. They’re responding to the attention they get when they participate in a clinical trial. “They receive both T.L.C. and good general medical and humane care, which they did not receive until now. That’s a sad commentary on the way we treat dementia patients.”

To family members looking at a nursing home for an aging parent, experts recommend seeking out homes with low staff turnover, a high ratio of staff members to patients, and programs with psychosocial components.

The Medicare Web site has basic information on individual homes at www.medicare.gov/NHcompare. The National Citizens’ Coalition for Nursing Home Reform, at www.nccnhr.org, offers a consumer guide to choosing a nursing home.

If medications are necessary, a family member should communicate with the prescribing doctor, learn the goal of each medication and be involved in making the decision.

Dr. Moak, of the psychiatry association, emphasized seeking out the doctor. Family members, he said, “often speak through the nursing staff, and that’s a huge mistake.”

Family members who are not convinced that a relative is receiving the best care should get a second opinion, as Ramona Lamascola did. The physician she consulted, Dr. Kennedy of Montefiore, stopped her mother’s antipsychotics and sedatives and prescribed Aricept.

“It’s not clear whether it was getting her hypothyroid and other medical issues finally under control or getting rid of the offending medications,” he said. “But she had a miraculous turnaround.”

Theresa Lamascola still has dementia, but she went from confinement in a wheelchair — unable to sit still and screaming out in fear — to being able to walk with help, sit peacefully, have some memory and ability to communicate, understand subtleties of conversations and even make jokes.

Or, as her daughter put it, “I got my mother back.”

* Hardly worth giving considering cost and side effects. 10% on a study done by the drug company, and where the standard of improvement is set deceptively low.

http://www.guardian.co.uk/society/2008/jun/19/health.health

Guardian June 19, 2008, by David Batty

Review ordered for dementia drugs

The government today ordered an immediate review into the use of antipsychotic drugs to calm the behaviour of people with dementia.

The drugs, also known as neuroleptics, have been labelled a "chemical cosh" by dementia charities and older people's campaigners, and some have severe side-effects, which include strokes and even death.

The review will be completed before the publication of the first national dementia strategy in October.

The practice of prescribing the drugs, such as risperidone, is widespread in nursing homes with around 60% of patients receiving them. But clinical evidence suggests they do more harm than good, and are prescribed more to contain behaviour rather than treat a condition.

There are an estimated 570,000 people with dementia in England - 700,000 in the whole of the UK - and the government expects that to more than double to 1.4 million in the next 30 years.

The strategy, announced by the health minister, Ivan Lewis, is intended to improve dementia care across England.

Lewis said the strategy would have three main aims: to ensure early diagnosis and help for people with dementia, to improve the quality of their care and to increase awareness of dementia and remove the stigma associated with it.

Lewis said: Dementia is one of the greatest challenges facing NHS and social care services. That is why this first ever national dementia strategy is so important. The consultation is about ensuring the final strategy fulfils my commitment to bring dementia out of the shadows."

Paul Burstow, the Liberal Democrat MP for Sutton and Cheam who campaigned against the prescription of antipsychotics for dementia patients, said the review was "too little, too late".

He said: "The evidence is already compelling: these drugs don't treat dementia, they cut lives short. The US food and drug administration has just issued a black box warning against prescribing antipsychotics to older people. European drug regulators are likely to require much tighter prescribing rules."

A study funded by the Alzheimer's Research Trust and published in the Public Library of Science Medicine in April found that long-term use of antipsychotic drugs led to significant deterioration in the thinking and speech of dementia patients. For most, the drugs had no long-term benefit at all.

Other campaigners welcomed the announcement of the dementia strategy, but warned it needed significant extra investment.

Dementia care costs the NHS around £3.3bn per year and the health service in England spent £60.9m on dementia drugs alone during 2005.

Neil Hunt, chief executive of the Alzheimer's Society, said: "Today is a landmark day for people with dementia and their carers, as the government recognises dementia as a national priority.

"[Its] actions and proposals are a great start. Its review of antipsychotic drugs to stop their dangerous over prescription to people with dementia is urgently needed."