Florida Mulls Lawsuit Over Antipsychotic Programs

They're powerful psychotic drugs, used to treat conditions like schizophrenia. No one knows what their effects are on children, especially infants, yet within seven years the number of children prescribed the drugs in Florida's health insurance program for the poor has nearly doubled. There's no doubting one side effect, though - drugmakers watched sales soar, aided by a Florida program they helped create, The Daytona Beach News-Journal writes.

Florida is far from unique. Several states also noted the costly boom of atypical antipsychotics, and are suing drug makers, alleging the companies pushed newer, untested drugs that proved no more effective in treatments - but were far more costly. In Florida, the taxpayers' bill for the drugs jumped from $9 million seven years ago to nearly $30 million in 2006. Whether Florida will join states like Texas, Pennsylvania and South Carolina in trying to recoup some of those costs is unclear, the paper writes.

"Our office is aware of concerns with antipsychotics in Florida's Medicaid program but we cannot acknowledge nor provide any information pertaining to ongoing criminal investigations," Sandi Copes, a spokeswoman with the Florida Attorney General's office, tells the paper.

Florida Medicaid records show the number of children - some just months old - who were prescribed the drugs went from 9,364 seven years ago to 18,137 in 2006. No records for privately insured patients are available.

In Florida, even as drugmakers were being told to issue warnings about risks, a Florida Legislature-directed program partly funded by pharmaceutical companies was recommending the drugs as treatment ADHD with tics or intermittent explosive disorder, according to the program's Web site that has since been shut down. According to a study that looked at three years of data, about 40 percent of the antipsychotics prescribed to Florida Medicaid children were given to children diagnosed with ADHD, a use not approved by the FDA.

The Florida program was patterned after a Texas project that has spurred a whistle-blower lawsuit. The Florida Algorithm Project used some of the Texas-developed medical formulas that recommended drug treatments for mental diseases. A year ago Texas joined the whistle-blower suit against Janssen Pharmaceutica and several other Johnson & Johnson subsidiaries. The suit alleges the program's treatment guidelines - "improperly influenced" and paid for by drugmakers - increased sales of the antipsychotic Risperdal. An official with Janssen said the company will defend its actions.

In 2002, the Florida Legislature permitted the Department of Children & Families to accept grants from pharmaceutical manufacturers to develop training for health care organizations serving public sector clients, according to a September 2003 Agency for Health Care letter about the Florida program.

When first interviewed, those familiar with the program said they did not recall any ADHD-related information. But archived pages from the program's Internet site show the program had more guidelines on how to treat ADHD than any other ailment. A 2004 report about the program's progress pointed to the development of an ADHD guideline as an accomplishment.

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