NEW YORK — A new study financed by the U.S. government sheds new light on the system that promotes and approves new drugs, and shows the need for strict- er guidelines to better protect consumers and reduce unnecessary government spending.
The study, sponsored by the National Institute of Mental Health, compared four new-generation drugs, and one older drug, used to treat schizophrenia, a mental disorder that affects more than 3 million people in the United States. It involved an 18-month clinical trial involving 1,400 adults from around the nation.
The trial, called the Clinical Antipsychotic Trials of Intervention Effectiveness, or CATIE, measured how long patients continued to take their assigned drugs before they switched because of the feeling that their drug wasn’t working or was causing serious side effects.
All drugs in the trial were effective in blunting symptoms of schizophrenia, such as delusions and hallucinations. Treatment with these drugs enables many patients to leave mental hospitals and return to a relatively normal life.
Perhaps the best known description of the problems schizophrenic patients face is that of John Forbes Nash, Jr., a brilliant mathematician and Nobel laureate, and the subject of the 2001 Academy Award-winning film “A Beautiful Mind.”
The CATIE trial showed that, although the drug olanzapine, marketed by Eli Lilly as Zyprexa, was slightly more effective than the others, patients treated with olanzapine tended to gain more weight. Olanzapine also had negative effects on glucose and lipid metabolism, thus increasing the risks of becoming obese and developing diabetes and heart problems. (Weight gain is one of the most common reasons patients give for discontinuing this medication.)
Perhaps the most significant finding in the study is that the oldest and cheapest drug selected for the trial, perphenazine, was as effective as the newer medications. Perphenazine costs $50 a month, while other drugs such as Zyprexa cost up to 12 times more. The study didn’t evaluate some newer drugs on the market.
The new drugs represent $10 billion in annual sales. The fact that the older and cheaper drug was as effective as the newer ones in treating schizophrenia probably won’t change private doctors’ prescription patterns. But the findings will probably have a big effect on state Medicaid programs, many of which are short on funds because of the high cost of schizophrenia drugs.
The CATIE trial is particularly significant because, unlike previous short-term trials in which the drug under study was compared to a placebo, the drugs were compared with each other in terms of efficacy. The finding that the cheapest drug is as efficient as newer, more expensive ones will result in huge direct savings for consumers. It will also benefit them indirectly by diminishing Medicaid’s huge expense load in antipsychotic drugs.
One should not conclude that the newer drugs for schizophrenia should be automatically discontinued. They should be specifically tailored to every patient with the potential benefits and side effects taken into account. In that regard, it is important to assess each patient’s risk factors when a medication is chosen.
This study shows that consumers should be wary of promotional campaigns conducted by drug manufacturers that promise to deliver better drugs without substantiating their claims with facts. At a policy level it shows the need to place more stringent demands on drug approval and promotion, and to show the evident benefits by comparing drugs with each other rather than to a placebo. At stake is the health and well-being of millions of people who rely on the government for their protection.