October 16, 2006
More and more often, it seems, drugs that were widely thought to be effective against serious illnesses turn out to show little or no value when tested in large, impartial clinical trials insulated from drug company influence. The latest example is a class of drugs known as atypical antipsychotics that are commonly used to soothe agitation, delusions and aggression in people with Alzheimer’s disease.
A government-sponsored study published in The New England Journal of Medicine last week found that the drugs are no more effective than placebos for most patients and carry troubling side effects, like sedation and confusion.
This was the third major study in the last year to cast doubt on the atypical antipsychotics, which were supposedly a significant advance over the first generation of antipsychotics. The earlier drugs had been enormously successful in alleviating the symptoms of schizophrenia, allowing patients to leave hospitals. But they often caused severe side effects that the newer drugs were designed to avoid.
Unfortunately, enthusiasm for the newer drugs proved misplaced. A government-sponsored study published last year found that three of the atypical antipsychotics were no better than an older, far cheaper drug for treating schizophrenia. A study sponsored by the National Health Service in Britain reported last week that schizophrenics did as well or better on the first-generation drugs.
The latest study focuses on the “off label” use of atypical antipsychotics to treat Alzheimer’s patients for the agitation and behavioral problems that at some point afflict most of them. Their popularity for this unapproved use — despite a label warning of dangerous side effects — reflects the dearth of better options, and word-of-mouth promotion by company-sponsored doctors.
The new study, which tested three of the atypical antipsychotics in a group of 421 patients around the country, found them no better than a placebo. That does not mean that the drugs are useless. They may be helpful to some patients who are carefully chosen and monitored by their physicians.
These discouraging results speak mostly to the desperate need for effective new treatments for Alzheimer’s, as well as the need to be wary of off-label uses that are not supported by well-conducted trials. But they also underscore the great value of impartial, government-sponsored studies that have — three times in the past year — punctured the myth that new and expensive brand-name drugs are necessarily superior to older and cheaper medications.