New Jersey's Medicaid program spent more than $73 million on antipsychotic medications for children less than 18 years old between 2000 and 2007, according to state records, even though the drugs weren't approved by the FDA for treating kids. And a state official acknowledges the drugs may have been prescribed for conditions other than schizophrenia and bipolar disorder, the approved uses. As a result, a state legislator is calling for an investigation and is formulating legislation.
"There are horror stories about these meds and there's a reason they're not prescribed for kids," says New Jersey assemblyman Pat Diegnan, who adds that he plans to draft a bill to change the practice and to hold talks with the New Jersey attorney general's office, which recently formed a task force to examine interactions between pharma and docs. "The entire issue is frightening and the state should be taking a closer look at this. I'm concerned about the casual prescribing by doctors and the enormous amount of money being spent."
The disclosure comes amid growing debate over antipsychotics. At issue are fears that children are misdiagnosed; drugs are inadequately studied; some docs presribe the pills too readily, and drugmakers promote the meds improperly. As reported previously, a growing number of states are suing various drugmakers over marketing that led Medicaid programs to pay unnecessarily for the meds.
Florida, for instance, is reviewing whether antipsychotics were prescribed improperly for ADHD. "There are no studies that have shown they (atypicals) are safe, or for that matter, that they are effective for children," Ronald Brown, a Temple University pediatric psychology professor who headed an American Psychological Association committee that examined the issue, told The St. Petersburg Times last year. "The bottom line is that the use of psychiatric medications far exceeds the evidence of safety and effectiveness."
UPDATE: Brown called us directly to say this: "The issue at hand is that the health care system is completely inadequate to deal with childrens' mental health needs. There's simply insufficient coverage for kids and adolescents....We don't know the long-term outcomes. So more research needs to be done and, simultaneously, more services need to be provided."
In their defense, New Jersey Medicaid officials say payments are made for any drug that is approved by the FDA, regardless of whether off-label usage is involved. "We don't practice medicine and we don't second guess prescribers," says Kaye Morrow, assistant director for Medicaid in the Department of Health's division of medical assistance and health services. "If there's an FDA approval for a drug and there's no restriction on a drug, we pay for it."
However, she adds that usage will be examined and data is being gathered by an outside contractor, Comprehensive NeuroScience, a consulting firm that helps states manage their drug costs. The practice, however, is controversial because Lilly, which markets Zyprexa, provides funding that pays for the firm's services. Such arrangements have been criticized elsewhere, because the drugmaker will monitor ’sloppy prescribing’ by docs, but only if a state agrees to let docs prescribe Zyprexa without first seeking permission from the state. A NJ health department spokeswoman maintains the state avoids this problem because its Medicaid program doesn't have a formulary and, therefore, a mechanism isn't in place to influence docs and their prescribing habits.
Meanwhile, though, the FDA has begun approving antipsychotics for youngsters of certain ages. Last summer, Johnson & Johnson's Risperdal was approved for schizophrenia in teenagers and bipolar disorder in children ages 10 to 17. Last fall, Bristol-Myers Squibb's Abilify was also approved for teenagers and Lilly's Zyprexa is being reviewed by the FDA for similar usage.