Study stumps researchers

Schizophrenia patients do as well, or perhaps even better, on older psychiatric drugs compared with newer and far costlier medications, according to a study published Monday that overturns conventional wisdom about anti-psychotic drugs, which cost the United States $10 billion a year.

The results are causing consternation. Researchers who conducted the trial were so certain they would find the opposite that they went back to make sure the research data had not been recorded backward.

The study, funded by the British government, is the first to compare treatment results from a broad range of older anti-psychotic drugs against newer ones. The study was requested by Britain’s National Health Service to determine whether the newer drugs – which can cost 10 times as much as the older ones – are worth the difference in price.

There has been a surge in prescriptions of the newer anti-psychotic drugs in recent years, including among children.

The study, published in the Archives of General Psychiatry, is likely to add to a growing debate about prescribing patterns of anti-psychotic drugs. A U.S. government study last year found that one of the older drugs did as well as newer ones, but at the time many American psychiatrists warned against concluding that all the older drugs were as good.

Monday, in an editorial accompanying the British study, the lead researcher in the U.S. trial asked how an entire medical field could have been misled into thinking that the expensive drugs, such as Zyprexa, Risperdal and Seroquel, were much better.

“The claims of superiority for the (newer drugs) were greatly exaggerated,” wrote Columbia University psychiatrist Jeffrey Lieberman. “This may have been encouraged by an overly expectant community of clinicians and patients eager to believe in the power of new medications. At the same time, the aggressive marketing of these drugs may have contributed to this enhanced perception of their effectiveness in the absence of empirical information.”

Peter Jones, a psychiatrist at the University of Cambridge in England who led the study, searched Monday for the right word to describe what had happened to his colleagues.

” ‘Duped’ is not right,” he said. “We were beguiled.”

One drug maker immediately questioned the findings. Carole Puls, a spokeswoman for Eli Lilly and Co., which makes Zyprexa, said it was problematic to compare large groups of medications because there are differences between the drugs in each class. Individual patients need different medication options, she said.

Janssen Pharmaceutica, which makes Risperdal, and AstraZeneca, which makes Seroquel, did not respond to requests for comment.

Schizophrenia is a mental disorder believed to affect about one in 100 adults. It is typified by psychotic symptoms such as hallucinations and delusions and negative symptoms such as social withdrawal.

Especially over the past decade, older anti-psychotics such as Haldol have been widely criticized for triggering uncontrolled body movements, even as the new “atypical” anti-psychotics were hailed for causing fewer side effects. Recently, however, concern has grown that anti-psychotics in general, and some of the newer drugs in particular, may be causing metabolic side effects.

The new study randomly assigned 227 schizophrenia patients to two groups – one received a newer anti-psychotic, the other an older drug. The patients were evaluated for more than a year by experts who did not know which drug was being taken.

While the researchers had expected a difference of five percentage points on a quality-of-life scale – showing the newer drugs were better – the study found that patients’ quality of life was slightly better when they took the older drugs.