AUSTIN – Texas has spent nearly $300 million since 2003 on expensive anti-psychotic medications for poor children – drugs that cost more, have worse side effects in kids and are no more effective than older generics, according to a new federal study.
The drugs, known as atypical anti-psychotics, are designed to treat schizophrenia but are also used for everything from autism to attention deficit disorder. Pharmaceutical firms have aggressively marketed the drugs to child psychiatrists and state health officials. And because they don't cause tremors and joint aches, as older drugs do, prescriptions for kids have increased fivefold in the last 15 years.
But the government study of Janssen's Risperdal and Eli Lilly's Zyprexa, two of the top five most commonly prescribed atypical anti-psychotics, found neither performed any better in children and adolescents than an older generic drug – and both led to unhealthy weight gain.
Drug companies have said the study didn't accurately reveal the side effects of the older drug, because patients on it were given a medication to offset them.
"When these were first coming out, let's not forget that there was a reason – the disabling side effects of the first generation drugs," said Eli Lilly spokesman Jamaison Schuler. "That's being lost in the context of this study."
Still, the findings are raising questions about years of prescription trends in Texas and the nation. In 2007 alone, Texas Medicaid records show, prescriptions for Risperdal were written to thousands of underprivileged children – including 2,500 10-year-olds, 2,000 5-year-olds and 25 1-year-olds.
"States have spent a tremendous amount of money unnecessarily for drugs that are no safer than the older drugs that are a fraction of the cost," said Allen Jones (Left), a Pennsylvania whistleblower who investigates drug company influence. "It appears, based on what the science is telling us, that an enormous amount of money was spent for no real benefit."
The study may also bolster a state lawsuit – originally filed by Mr. Jones but joined by Texas Attorney General Greg Abbott – against Janssen over allegations the company improperly influenced state officials to add Risperdal to a list of preferred drugs. Officials from Janssen did not return phone calls, but they have previously denied any such action.
The federal study, published by the American Journal of Psychiatry, compared the two atypical anti-psychotics with an older drug, molindone.
While all three drugs reduced hallucinations, children on Zyprexa gained so much weight so fast – as much as 15 pounds in eight weeks – that a safety panel took them off the drug. Risperdal also caused substantial weight gain, while children on molindone gained less than a pound on average.
Both groups of children on the new drugs experienced metabolic changes that heightened their risk for diabetes. Researchers considered those side effects worse than the tremors and joint aches, which can be treated with other medications. The study's authors said that while both classes of anti-psychotics have some adverse effects, those associated with the new drugs are more likely to have persistent, "long-term effects on physical health."
Texas has spent a combined $150 million on Zyprexa and Risperdal for poor children in the last five years, state records show. More than $7 million was for foster children.
Between 2002 and 2007, Texas foster children were written more than 25,000 prescriptions for Risperdal, at an average cost of $253 per prescription. They were written 3,400 prescriptions for Zyprexa at a cost of $469 per prescription, state records show. The older drugs generally cost a tenth of what the newer drugs do.
This spring, a state mental health plan naming the preferred psychiatric drugs for children was put on hold, over fears drug companies may have improperly influenced researchers to put their drugs on the list. That drug plan recommended treating attention deficit disorder patients who are aggressive with atypical anti-psychotics.
Meanwhile, the state lawsuit accuses Janssen of using false advertising and trips and other perks to get Risperdal listed on the Texas Medication Algorithm Project, which mandates the use of certain drugs for adults whose medications the state pays for. Individuals with knowledge of the case say it has spread to the children's drug protocol.
The latest study isn't the first to call the atypical anti-psychotics into question. A 2005 federal study by the National Institute of Mental Health showed the new anti-psychotic drugs performed no better than and had nearly as many side effects as the older ones.
A year later, a British national study mirrored those findings.
"We've got to look into this, particularly with this high cost," said state Sen. Bob Deuell, R-Greenville, a family physician who has patients who have been prescribed atypical anti-psychotics in state facilities. "If they're really helping these kids, we need to use them. But if these kids develop diabetes from them, and they don't work any better, it will only cost the state more money."