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By Daniel Carlat CNN
Although it's true that a prescription for antipsychotics to treat agitation in dementia is "off-label," this hardly means they are ineffective or that Medicare claims for these drugs are "erroneous." In fact, large placebo-controlled trials have shown that antipsychotics are the most effective medications for the agitation that often bedevils patients with dementia.
When these drugs are successful, they soothe the inner turmoil that makes life intolerable for these patients, improving their quality of life dramatically.
Off-label prescribing simply means the medicine has not undergone the vastly expensive process of gaining FDA approval. Doctors are allowed to prescribe medications off-label; indeed, without this prerogative, much of medical care would grind to a halt. More than 60% of drugs prescribed by both pediatricians and oncologists are "off-label," and almost all drugs prescribed by obstetricians fall into that category. Has your doctor every given you Valium to help you sleep? If so, your doctor was "erroneously" billing your insurance, according to the Office of the Inspector General, because Valium is FDA approved for anxiety, not for insomnia.
The unfortunate fact is that not a single medication is FDA-approved for the agitation of dementia, and yet the condition is common. About 15% of people over 65 have dementia, and half of them will develop agitation at some point. Anybody who has visited a loved one in the Alzheimer's unit of a nursing home understands agitation only too well; it includes combativeness, shouting, verbal abuse, extreme hyperactivity and sometimes outright violence to caregivers and family.
Agitation is often due to psychosis. For example, I recall one unfortunate gentleman with Alzheimer's disease who ripped an IV line out of his arm because he woke up in a strange room and believed his wife was in the next room calling his name. The room that seemed strange to him was a nursing home room he had occupied for three years, and his wife had died 15 years earlier.
This kind of agitation is dangerous for the patient, for staff and very upsetting for family members. When geriatric psychiatrists are asked to treat agitation, they look first for potential triggers that can be solved without resorting to behavioral drugs. Infections, drugs interacting with drugs, or pain are sometimes the culprits. At times, changes in the environment can help, such as increasing contact with a caregiver, changing roommates, or even adjusting the room's temperature.
But in many cases, such measures don't help enough.
Antipsychotics, such as Risperdal, Seroquel, and Zyprexa, have all been shown to be convincingly more effective than placebos in quelling agitation in the elderly. Their vaunted "lethal" risks are based on data that is surprisingly unimpressive. When each antipsychotic was studied separately, no significant difference in mortality was found between patients on drugs or on placebos. But when data on thousands of patients were combined, the mortality rate with four specific drugs was 4.5% in the medication group vs. 2.6% in the placebo group. The most common causes of death? Heart failure and pneumonia, which are the most common causes of death for all patients with dementia.
Physicians are not prescribing these medications in order to do harm to their patients. They are using them because there are no better options. Antipsychotics, by helping patients to be calm, are humane treatments for patients who are reaching the end of their days.
The solution is to expand research on safer and more effective treatments of dementia. It is not, as proposed by Levinson, to hire government auditors to decide whether doctors are prescribing drugs "appropriately." God help us if they do.