HOW AWFUL: THE BEST DRUG FOR SCHIZOPHRENIA ALSO HAS THE MOST SIDE-EFFECTS

When you find a drug with no side effects, you will also usually have found a drug with no main effects either. Patients should of course always be warned of common side-effects but that should be the end of it. Side effects will always be with us for the foreseeable future. You cannot regulate them away

"The biggest-ever study of treatments for schizophrenia emphasizes how difficult the disease, which afflicts 3.4 million Americans, is to treat, and how often patients fail to experience relief from the first drug they try. Eli Lilly's Zyprexa was the most effective drug in the trial, but its victory was dulled by the medicine's side effects, and by the fact that Zyprexa was given in doses higher than are allowed on its prescribing label, while the other drugs were not.

Three times out of four, patients could not get satisfaction from the first drug they were prescribed in the study. They tended to switch either because of side effects, such as severe weight gain or neurological tremors, or because the drugs didn't ease the delusions, hallucinations and emotional numbness that can cripple schizophrenia patients. "These treatments are effective--there's no doubt about that," says Jeffrey Lieberman, chairman of the department of psychiatry at Columbia University and director of the New York State Psychiatric Institute, who designed and ran the trial. "But the glass is only half full."

The data from the study, called the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE), could also send shock waves through the $14 billion market for antipsychotic drugs. The CATIE results were released at a press conference by the National Institute of Mental Health, which funded the trial. As first reported on Forbes.com last Friday, the results will be published in Thursday's New England Journal of Medicine. The results of the study closely mirror what was predicted here last week

CATIE hands a major victory to Zyprexa, the top-selling drug for Eli Lilly, which has been losing market share in the U.S. Some 64% of patients on Zyprexa were switched to another drug, compared with 75% or more of the patients taking the other drugs. "I don't think people were ready for this," says Leslie Citrome, a professor of psychiatry at the New York University School of Medicine, who did not participate in the study. "I think people were ready to bury [Zyprexa]."

But the data are a double-edged sword for Lilly, because they also show that Zyprexa causes more weight gain, high blood sugar and raised cholesterol than its competitors do. By comparison, patients taking Pfizer's Geodon, on average, experienced no weight gain and fewer of the neurological tremors that can be a serious problem for schizophrenia patients. Lieberman, who headed up the study, agreed that Pfizer now might have grounds to say its drug has milder side effects. Worries about changes in heart rhythm that had plagued Geodon after it was approved did not turn up in CATIE. But 79% of patients switched off of Geodon, so for the sickest patients, physicians may want to turn to the more powerful drugs.

One clear message from the trial is that the medicine that is right for one patient may not be right, in terms of either effectiveness or side effects, for another. One surprise for many was that the drug perphenazine, an antipsychotic that was discovered in the 1950s and is now a dirt-cheap generic, did as well as the other drugs. Symptoms of tardive dyskinesia, a kind of involuntary movement, didn't show up in the study. However, such neurological side effects can take years to develop, as in the case of jazz musician Tom Harrell, who experienced severe neurological symptoms after years on one of the older drugs. He was eventually switched to Zyprexa, which caused weight gain, and then to AstraZeneca's Seroquel, another drug used in the CATIE study. Once he found the right drug for him, he actually lost weight, and his symptoms were well controlled

One big question that remains is whether Zyprexa would have done as well if it had been given in the doses for which the drug was approved, as the other drugs in the study were. In actual practice, schizophrenia drugs tend to be given in doses higher than the approved levels. According to Lieberman, the investigators approached the makers of all the drugs being used in CATIE with proposed dose ranges that went above what the U.S. Food and Drug Administration had approved.

However, Lieberman says, only Lilly agreed to provide its drug to CATIE investigators at the higher doses. Pfizer, AstraZeneca and Johnson & Johnson, which makes Risperdal, did not want to use the higher doses. Astra and Lilly do not dispute that account; the other companies could not be reached for comment.

More here

***************************

For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

***************************