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Wrong Drugs Used in Dementia

Drug News--disappointing

 

Four problems with giving tranquilizers in nursing homes.  First there is a conflict of interest, for they bill the state for prescribing and profit from filling the prescriptions.  Second, the immediate want of the staff for an easily managed populace entails that they favor drugging those in their care, this is often done contrary to the quality of existence of the patients.  Third are side effects, which go unnoticed, or in the case of tranquilizers are wanted (easier to manage vegetables).  Fourth and ignored, is putting patients under.  I lost a close friend, Terry Seemens who was in a hospice with lung cancer that had spread to his brain.  He died within 4 hours of seeing him in exceptionally chipper.  The staff had drugged him just as I was leaving, for he was hallucinating.  They had nearly killed him the night before on a similar load of tranquilizers.  Patients die at twice the rate with Alzheimer’s on a cocktail of tranquilizers the article below exposes. 

 

IT IS A COMMON PRACTICE FOR MANUFACTURERS OF DRUGS TO GIVE THE NURSING HOME A KICK-BACK FOR PRESCRIBING OF THEIR DRUG.  Moreover, the typical physician has since graduating medical school been receiving various rewards from the pharmaceutical companies. 

 

Washington Post.com

January 9, 2009,

Steven Reinberg, HealthDay Reporter

http://www.washingtonpost.com/wp-dyn/content/article/2009/01/09/AR2009010901509.html

Antipsychotics Up Death Risk in Alzheimer's Patients

 

FRIDAY, Jan. 9 (HealthDay News) -- Alzheimer's patients who are prescribed antipsychotic drugs face a higher risk of death than similar patients not given these medications do, British researchers report.

While the short-term use of antipsychotics has been found to benefit Alzheimer's patients, studies have found that prolonged use can have serious side effects, including Parkinson-like symptoms, sedation, chest infections, decline in brain function, stroke and death.

"It's an eye-opening study since it was one of the few non-company sponsored studies to look at long-term risks," said dementia expert Dr. P. Murali Doraiswamy, chief of the biological psychiatry division at Duke University.

"Antipsychotics are not and never were indicated for use in people with dementia," he added. "But millions of elderly [people] were put on antipsychotics in nursing homes, often with little or no evidence to support such use."

For the study, lead researcher Dr. Clive Ballard, of the Wolfson Centre for Age-Related Diseases at King's College London, and his colleagues randomly assigned 128 Alzheimer's patients to one of several antipsychotics or a placebo. The antipsychotic drugs included thioridazine, chlorpromazine, haloperidol, trifluorperazine or risperidone.

The researchers found that, for the whole study period, the risk of death was 42 percent lower among people taking a placebo compared with those taking antipsychotics.

After one year of follow-up, 70 percent of the patients taking antipsychotics were still living, compared with 77 percent of those on placebo.

But after two years, 46 percent of those taking antipsychotics were alive, compared with 71 percent of those taking placebo. And after three years, only 30 percent of those on antipsychotics were alive, compared with 59 percent of those taking a placebo, the researchers found.

The findings were published online Jan. 8 in The Lancet Neurology.

Despite the findings, Doraiswamy said there's still a place for antipsychotics in some people with dementia. "If there is no other way to stop an Alzheimer's patient from acting dangerously and all other measures have failed, then antipsychotics can be used as a measure of last resort, but only for the shortest possible time at the lowest possible dose," he said.

The study authors agreed.

"Our opinion is that there is still an important but limited place for atypical antipsychotics in the treatment of severe neuropsychiatric manifestations of Alzheimer's disease, particularly aggression," the researchers wrote. "However, the accumulating safety concerns, including the substantial increase in long-term mortality, emphasize the urgent need to put an end to unnecessary and prolonged prescribing."

William Thies, chief medical officer at the Alzheimer's Association, said his group suggests that "non-pharmacological treatments" may be as effective as the antipsychotic drugs and should be considered first.

"Non-pharmacological treatments are things like changing the environment of the patient, changing the way the patient is addressed, and eliminating certain triggering events that may cause deteriorations in patient behavior," he said.

More information

For more on Alzheimer's disease, visit the Alzheimer's Association.

What You Need to Know About Antipsychotics"Families need to be on the lookout and question their doctor closely if he or she recommends an antipsychotic for Alzheimer's," said Dr. P. Murali Doraiswamy, chief of the biological psychiatry division at Duke University.He said families need to ask:What is it for? Why did you choose it? Is this the lowest dose that works? Have you considered an alternative? How long will my relative need to be on it? How often will my relative be checked for side effects?

SOURCES: P. Murali Doraiswamy, M.D., chief, biological psychiatry division, Duke University, Durham, N.C., William Thies, Ph.D., chief medical officer, Alzheimer's Association; Jan. 8, 2009, The Lancet Neurology, online

 

Wrong drugs used in dementia, experts say

June 24, 3008, Tracy Staton, Fierce Pharma at http://www.fiercepharma.com/story/wrong-drugs-used-dementia-experts-say/2008-06-24?utm_medium=nl&utm_source=internal&cmp-id=EMC-NL-FBR&dest=FP

“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’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.”

 

 

New York Times, Health section,

June 23, 2008  by Laurie Tarkan

 

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’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.”

 

 

 

 

 

 

Those who have a financial interest in the outcome manipulate the results