New Antipsychotic Drugs Criticized

Expensive new antipsychotic drugs that are among the most widely prescribed pills in medicine are no more effective and no safer than an older, cheaper drug that has been largely discontinued, according to the most comprehensive comparative study ever conducted.

The surprising result of a federally funded study released yesterday challenges widespread assumptions among psychiatrists about the best way to treat serious mental illness and underscores the extent to which physicians, patients and policymakers can be blindsided by self-interested research by drugmakers.

The study also paints a sobering picture of the state of treatment of schizophrenia, a disabling illness that afflicts about 3.2 million Americans with symptoms such as delusions, hallucinations and disordered thinking: Every drug, old and new, caused serious side effects, and the vast majority of patients stopped taking each of them.

"The study has vital public health implications," said Thomas Insel, director of the National Institute of Mental Health, which funded the study. "It is the largest, longest and most comprehensive, independent trial ever done to examine existing therapies for this disease."

Heavily marketed on the grounds they caused fewer side effects, the newer drugs, known as atypical antipsychotics, cornered about 90 percent of the market.

All won Food and Drug Administration approval on the basis of short-term studies that showed they were better than sugar pills, and researchers emphasized yesterday that the medicines do work. But they have never before been systematically compared against each other in a long-term trial designed to guide doctors in deciding which to try first, and which would best suit particular patients.

The new study tracked patients for 18 months, which allowed researchers to compare the effectiveness of the medications as they actually are used. Patients had a variety of complicating factors, much as they do in the real world, and came from diverse backgrounds.

Columbia University psychiatrist Jeffrey Lieberman, who led the new study, said 90 percent of trials in the scientific literature -- which doctors rely on to guide treatment -- are sponsored by drug companies. Although the industry trials serve a useful purpose, he said, they are rarely designed to answer certain crucial questions.

The industry has recently come under fire for hiding unfavorable trial data, especially in studies of antidepressant medications for children. Companies conduct trials to win FDA approval or for marketing reasons, Lieberman said.

"These are not the same purposes that are consistent with the needs of clinicians, patients, family members, administrators and policymakers," he said. "How do currently marketed treatments compare? If there are differences in cost, are they justified? There has not been any consistent means to get that information."

Although the National Institutes of Health is increasingly funding such trials, Lieberman said they also ought to be funded by federal agencies that pay for drug treatment for huge numbers of patients, such as the Centers for Medicare and Medicaid Services (CMS).

"CMS pays tens of billions to support medication, and there is no way they know what the appropriate value of these medications is," he said.