Florida undecided as states sue over costly drug program
By M.C. MOEWE, staff Writer
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 — drug companies watched sales soar, aided by a Florida program they helped create.
Florida is far from unique. Several states also noted the costly boom of atypical antipsychotics — a new class of the drug that was touted to have fewer side effects. The states 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.
“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,” said Sandi Copes, a spokeswoman with the Florida Attorney General’s office.
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.
“The situation is out of control,” said David Cohen, a professor at Florida International University who has been studying the use of antipsychotics since 1983. While no long-term studies have been done on the effects the drugs have on children, there is evidence children on the drugs face greater risks of diabetes, hyperglycemia and extreme weight gain, Cohen said.
‘MOOD STABILIZERS’
Orange City child psychiatrist Manuel Mota-Castillo said age shouldn’t be a factor in determining whether the drug is needed. He has prescribed antipsychotics to children frequently, with the youngest being a 25-month-old child.
“I don’t want to use the name ‘antipsychotic.’ I use ‘mood stabilizer,’ ” said Mota-Castillo, who also worked for three years at Act Corp., the area’s main mental health facility.
The 25-month-old child had been kicked out of five day-care centers where complaints included punching other children, he said. “The child’s mother came to me in shorts so I could see the bruises and marks (on her),” he said.
Crystal Lamson of Sanford said Mota-Castillo has been treating her bipolar son for more than two years. Ryland, now 7, broke a Plexiglas window at a day-care center when he was 5.
“I get criticized all the time from family members,” Lamson said. “(But) there are some children out there who do need them.”
Another Sanford parent, Richard Davis, said he watched in horror as his daughter Ciara, then 6, gained 40 pounds, developed breasts and had uncontrollable tongue and facial movements.
“Those drugs were killing her,” Davis said.
Over his objections, he said Ciara was given antipsychotics by her mother and while in foster care. A court-appointed guardian also noted the effects in an August 2003 report, describing a visit in which Ciara “never once kept her tongue in her mouth.”
Ciara, now 11, was taken off the drugs after about a year, her father said, and she quickly dropped the added weight.
‘TAINTED’ MONEY
In Florida, even as drug makers were being told to issue warnings about risks, a Florida Legislature-directed program partly funded by pharmaceutical companies was recommending the drugs as treatment for attention deficit hyperactivity disorder (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 Food and Drug Administration.
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 the drug companies –increased sales of the antipsychotic Risperdal.
An official with Janssen said the company will defend its actions.
“We believe our participation in all aspects of our Texas Risperdal activities were in accordance with what the law required,” said Ambre Morley, a company spokeswoman.
Florida pilot programs using the Texas-developed guidelines began in 2001, according to state documents. Act Corp. in Volusia County was one of 15 sites that adopted the program until it was discontinued in September 2004.
James Bax, a former director of the Florida program, said the project began with funding from pharmaceutical companies.
“It did not take me long to realize that the money from the drug companies was tainted,” Bax said. “Once I got into it, I saw what I thought was very insidious.”
According to the program’s defunct Web site, Bax was director only a couple of months before a retired Johnson & Johnson employee took the title.
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.
Rajive Tandon, chief psychiatrist for the Mental Health Program Office with Florida’s Department of Children & Families, said he’s not sure how much impact the Florida program had on the increased use of antipsychotics.
“It certainly was a contributing factor,” he said.
Doctors believed the new antipsychotics were better, Tandon said, citing “aggressive marketing.”
But the new antipsychotics proved no more effective than older drugs in two significant studies — one published in 2005 in the New England Journal of Medicine and another in the Journal of the American Medical Association published in 2003, said Cohen, the antipsychotics expert at Florida International.
Tandon said Florida should consider a lawsuit like other states.
“Should we at least look into it? Absolutely,” he said, calling for, at minimum, an investigation into the Florida program’s funding and impacts. “Then basically hold the appropriate people responsible.”
– News researcher Janice Cahill contributed to this report.
More Drugs
Atypical antipsychotics were touted to have fewer side effects than older antipsychotics, and their use increased among children in Florida’s Medicaid program under guidelines that drug companies helped create between 2000 and 2006.
As I wrote earlier, the longest study actually performed while following live children was the MTA and its 3-Year Follow-up of the NIMH MTA (multi-modal treatment) recently published in the journal of the American Academy of Child and Adolescent Psychiatry.
Co-author, Professor William Pelham, of the University at Buffalo, says: “The children had a substantial decrease in their rate of growth so they weren’t growing as much as other kids both in terms of their height and in terms of their weight. And the second was that there were no beneficial effects – none.”
Pelham adds, “In the short run [medication] will help the child behave better, in the long run it won’t. And that information should be made very clear to parents.”
Here’s the most telling observation of the study: “I think that we exaggerated the beneficial impact of medication in the first study. We had thought that children medicated longer would have better outcomes. That didn’t happen to be the case. There’s no indication that medication’s better than nothing in the long run.”
It’s obvious that this information was not good for the pharmaceutical industry. As is now common practice, a study will be launched to counter this kind of negative press. So, it was no surprise that the respected Mayo Clinic released a study two months later that “…reveals that compared to children without AD/HD, children with ADHD are at risk for poor long-term school outcomes such as low achievement in reading, absenteeism, repeating a grade, and dropping out of school. Both studies appear in the current edition of the Journal of Development & Behavioral Pediatrics, (http://www.jrnldbp.com).”
“In this study, treatment with stimulant medication during childhood was associated with more favorable long-term school outcomes,” explains William Barbaresi, M.D., Mayo Clinic pediatrician and lead author of the reports.
The MTA study focused on real families in real-time. The researchers were able to observe family dynamics, environment, pharmacological interventions and their relationships to academic and behavioral outcomes. This, of course, takes a significant amount of time and field researchers.
According to the Mayo Clinic Press Release, “The two Mayo Clinic studies are the first population-based, long-term studies to investigate links between ADHD, school performance and factors that modify long-term school performance of children with ADHD.”
Here’s how research like this works: researchers are given access to school files and medical records. They select and review data from files to draw their conclusions. This is becoming more popular than live research because it is less expensive, doesn’t require a significant number of field researchers, and can be done in less time. Unlike real-time research like the MTA, the Mayo study’s limitations are significant; it doesn’t allow real-time access to families or teachers to gain information regarding environment, family issues, etc; to interpret information; or to clarify written information. So the researchers are fairly limited to test scores and medical records. While this makes it easy to prepare and select data, it falls far short the information gather by a real-time study.
The Mayo study press release summarizes the research:
Dr. Barbaresi believes that both studies provide the first solid evidence of the long-term negative academic performance associated with untreated ADHD – as well as evidence for the best way to manage this problem. Dr. Barbaresi says, “The finding that treatment with stimulant medications is associated with long-term improvement in school outcomes is significant. Previously, there was evidence that treatment with stimulant medications improved short-term academic performance, but there was no good evidence that long-term outcomes are better with stimulant treatment. Our data can guide clinicians in their efforts to help children with ADHD succeed in school.”
Note that no mention is made of height and weight loss of children in the Mayo Clinic study as was found by the MTA. Furthermore it also directly contradicts information released by the MTA. Here’s the rub, funding for the Mayo study was contributed by grants from the U.S. Public Health Service; National Institutes of Health; Mayo Clinic Foundation for Biomedical Research; and McNeil Consumer and Specialty Pharmaceuticals.
Obviously the one extraordinary contributor was McNeil Consumer and Specialty Pharmaceuticals. McNeil is the producer of Concerta, a stimulant medication for ADHD. Is it likely that McNeil would contribute to a study that would indicate weight loss and stunted growth from use of its product? Not likely.
Would McNeil contribute to a study whose researchers said, “I think that we exaggerated the beneficial impact of medication in the first study. We had thought that children medicated longer would have better outcomes. That didn’t happen to be the case. There’s no indication that medication’s better than nothing in the long run.” Not likely.
It is a direct conflict of interest for a pharmaceutical company to participate in research with universities, hospitals, or other entities. I’ve never seen negative information released from a study performed by a pharmaceutical company on their own drug. Strange, isn’t it?
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