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Florida undecided as states sue over costly drug program
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. Here's a rundown on the drugs that have been
prescribed. Brand name; drug maker; number of prescriptions Risperdal; Johnson & Johnson subsidiary; 304,762 Seroquel; AstraZeneca; 161,823 Zyprexa; Eli Lilly and Company; 90,052 Abilify; Bristol-Myers Squibb/Otsuka; 82,499 Geodon; Pfizer; 28,884 SOURCE: Florida Agency for Health Care Administration. Data analyzed by Janice Cahill and M.C. Moewe |
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