New Schizophrenia Treatment at Issue

An older, inexpensive drug is as effective at treating the symptoms of schizophrenia as a newer, more popular drug that costs about 100 times more, according to a new report.

The study, published in today’s issue of the Journal of the American Medical Assn., also found no difference in quality of life between those given the newer drug, olanzapine, and those who received the older medication, haloperidol, plus another drug to control side effects.

Haloperidol treatment was $3,000 to $9,000 cheaper per patient in annual costs.

“The study raises serious questions about an accepted practice, which incurs huge cost,” said the study’s lead author, Dr. Robert Rosenheck, director of the Veterans Affairs Northeast Program Evaluation Center and a professor of psychiatry and public health at the Yale University School of Medicine.

However, he added, “this is only one study. I want to be cautious.”

Several psychiatrists agreed, saying the study’s findings did not warrant a shift back to the older class of drugs at this time.

Dr. Stephen R. Marder, a professor at UCLA and a staff psychiatrist in the Veterans Affairs Greater Los Angeles Health Care System, noted that patients taking haloperidol did experience small but significantly greater rates of a side effect known as akathisia, in which a person feels constantly restless.

Such feelings might not register on quality-of-life measures yet still disturb a patient -- more sometimes than hallucinations and delusions, Marder said.

The study was funded by Eli Lilly & Co., which sells olanzapine under the trade name Zyprexa.

Dr. Mauricio Tohen, Lilly’s product team leader for Zyprexa and an associate clinical professor at Harvard Medical School, said the study had a number of flaws, including a smaller number of enrollees than planned.

But other psychiatrists familiar with the study commended it as well-conducted, saying it was a valuable addition to the ongoing debate about different schizophrenia drugs.

“Everyone in this state is struggling to cope with the high costs of drugs for psychiatric disorders,” said Dr. George M. Simpson, chair of psychiatry at USC’s Keck School of Medicine. “This will be another thing to go into the debate.”

Schizophrenia is a devastating and poorly understood mental illness that afflicts more than 2 million Americans. It is an incurable disease characterized by hallucinations, delusions and disordered thinking.

The class of antipsychotics that includes haloperidol has been in use since the 1950s.

However, they produce a variety of troubling side effects, including the restlessness, tremors and involuntary body movements known as tardive dyskinesia.

In the last decade, patients have been treated with newer antipsychotics, known as “atypicals,” which do not cause those side effects.

However, olanzapine and some of the others have been shown to cause significant weight gain and diabetes in some patients. They are also far more expensive -- about $8 a day for olanzapine -- compared with about six cents per day for haloperidol.

Olanzapine is the leading atypical antipsychotic for schizophrenia, with annual U.S. sales of about $2 billion.

In the yearlong study, Rosenheck and his coauthors enlisted 309 patients with schizophrenia at 17 Veterans Affairs medical centers. Half were given olanzapine and the other half were given haloperidol and a drug called benztropine to control side effects. Neither doctors nor patients knew which drugs were administered.

Patients were regularly assessed for schizophrenia symptoms, side effects, cognitive and social functioning, quality of life and medical costs. Nearly 180 patients dropped out of the study before it was completed, but the researchers continued to track their progress.

The scientists found that haloperidol patients had mildly diminished scores on cognitive tasks and a slightly increased rate of tardive dyskinesia, along with the slightly increased rates of akathisia. Patients on olanzapine experienced more weight gain.

The scientists detected no statistically significant difference between the two groups in overall quality of life or symptoms of schizophrenia.

Dr. John M. Kane, executive director of the Zucker Hillside Hospital in New York City, cautioned that the population of patients in the study was not completely representative: They were older and had been ill for about 20 years.

A longer, National Institutes of Health-funded study comparing an older, haloperidol-like drug to four of the newer medications in 1,500 people is currently underway.