Please Comment - Antipsychotics for ADHD?????

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" 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 " ...

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Florida undecided as states sue over costly drug program

Daytona Beach News Journal

By MOEWE

January 10, 2008

NEWS: Front Page

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 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 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, , 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, " 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 & 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.

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 & 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.

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