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Adult anti-psychotics can worsen troubles

May 2, 2006 | USA Today

Evan Kitchens, a cheerful fourth-grader who loves basketball and idolizes his 16-year-old brother, had been hospitalized for mental illness by the time he was 8.

The boy from Bandera, Texas, was aggressive and hyperactive and had been diagnosed with a variety of other ailments, including obsessive-compulsive disorder and an autism spectrum disorder.

A couple of years ago, Evan was taking five psychiatric drugs, says his mother, Mary Kitchens. Two were so-called atypical anti-psychotics, a group of relatively new drugs approved by the Food and Drug Administration for treating adults with schizophrenia or bipolar disorder.

"Evan was a walking zombie on all those drugs," Kitchens says. At the harrowing nadir two years ago, she wondered whether her son would survive, let alone live a normal life.

Evan shook with severe body tremors and hardly talked. He had crossed eyes, a dangerously low white blood cell count and a thyroid disorder, all symptoms that emerged after he started the atypical anti-psychotic drugs, Kitchens says. Now, he has been weaned from the drugs and takes medicine only for attention-deficit disorder, she says. And he is mentally healthier than he has ever been.

These six new anti-psychotic drugs: Clozaril, Risperdal, Zyprexa, Seroquel, Abilify and Geodon are not approved for children, but doctors can prescribe them to kids "off label." And prescribing atypical anti-psychotics for aggressive children such as Evan is leading the field in a growing pediatric business, according to a new analysis of a federal survey by Vanderbilt Medical School researchers.

Outpatient prescriptions for children ages 2 to 18 jumped about fivefold from just under half a million to about 2.5 million from 1995 to 2002, the survey shows.

At the same time, reports of deaths and dangerous side effects potentially linked to the drugs are increasing. A USA TODAY analysis of Food and Drug Administration data shows at least 45 deaths of children from 2000 to 2004 where an atypical was considered the "primary suspect." More than 1,300 cases reported bad side effects, including some that can be life threatening, such as convulsions and a low white blood cell count.

Non-drug treatments

Treating children's disruptive behavior with pills is a complicated issue and the subject of debate among experts.

FOSTER CHILDREN: Oversight of prescriptions is scarce

"In my experience, and that of many psychiatrists, anti-psychotics are often overused for aggression in young patients," says Ronald Pies, a clinical professor at Tufts University and author of Handbook of Essential Psychopharmacology.

That doesn't mean it's necessarily wrong to give the pills, he adds.

Nobody disputes that the lives of schizophrenic or severely manic children might be saved by anti-psychotics. But many non-drug treatments can help to keep aggressive, disruptive children off the atypicals, says John March, chief of child and adolescent psychiatry at Duke University School of Medicine.

So much hinges on whether safer treatments can work for a child.

Kids who show up on anti-psychotics for aggression often can be weaned off if there are family changes, says behavioral pediatrician Lawrence Diller of Walnut Creek, Calif. For instance, adolescents may lash out angrily if their parents are fighting or discipline is inconsistent, Diller says. In a divorce, the child sometimes ends up with the less effective parent.

Last year, Diller saw an 8-year-old boy on four psychiatric drugs, including an atypical. He lived with his mother, "a highly anxious, incompetent parent." When he went to live with his father, his symptoms virtually disappeared, and he didn't need any drugs, Diller says.

Child psychiatrist George Stewart says he has seen dozens of aggressive children weaned off the atypical anti-psychotic drugs in his consulting work and as medical director of a residential treatment facility in Concord, Calif. Too often, he says, doctors give the drugs without considering family conditions or life experiences that cause aggressive behavior, which can be changed with intensive counseling. Three examples he offers:

  • A boy younger than 3 was treated with two anti-psychotics at a therapeutic preschool for kids with severe behavior problems. Stewart got a full family history, discovering his teen mother had a series of abusive boyfriends. "He was acting out due to that, but nobody took the time to find out what was going on at home," says Stewart, who worked with the mom to improve conditions. "She settled down." The child was taken off atypicals and is doing fine.
  • A 12-year-old boy with out-of-control rage "we're talking smearing poop all over the 'quiet room' " was treated at Stewart's center. Intensive therapy identified the sources of his rage and taught the boy how to cope. He returned home, off all meds.
  • A teen girl seemed to be intractably violent. "She was trying to stab pencils in people's eyes," Stewart says. It turned out she had been raped and experienced other severe trauma. She was weaned off anti-psychotics and counseled. Now in her late teens, she's living independently and doing well with no psychiatric drugs.

One of the most disturbing, potentially dangerous trends linked to atypicals is called "polypharmacy": routinely giving kids several psychiatric drugs, says child psychiatrist Joseph Penn of Bradley Hospital and Brown University School of Medicine in Providence. "We know very little about the interaction of these drugs, the effects they could be having on kids," he says.

The benefits of prescribing multiple drugs may outweigh risks in some cases, but Penn says he is appalled at how many times he has seen the mega-powerful atypicals prescribed to children suffering from insomnia when they're taking other medicines.

"I've seen hundreds of cases," he says, "and often parents don't seem to have been told about the many less risky prescription and non-prescription options out there."

Sometimes medical conditions or drugs for attention-deficit hyperactivity disorder cause the insomnia. Rather than attacking causes, doctors add an atypical to the mix, he says.

More research needed

There has been little carefully controlled, long-term research on children taking most psychiatric drugs, including the atypical anti-psychotics. The FDA is trying to get more pediatric research on the atypicals, says Thomas Laughren, the agency's director of the psychiatry products division.

The FDA has asked five pharmaceutical companies that make the drugs to test them in children with schizophrenia and bipolar disorder, the uses they're approved for in adults. Under law, they can get a six-month extension on their patents for doing these studies.

Also, the drug companies are doing their own pediatric studies on children with disorders as diverse as ADHD, autism, conduct disorder and Tourette's syndrome.

Janssen LP has applied to the FDA for approval to use its atypical anti-psychotic, Risperdal, in the treatment of symptoms of autism, says Ramy Mahmoud, vice president of medical affairs for Janssen.

The National Institute of Mental Health also is conducting pediatric studies, but the research is primarily funded and supervised by pharmaceutical companies.

Even if the companies win approval, it won't guarantee safety or effectiveness of the drugs in children, says David Graham of the FDA Office of Drug Safety, who emphasizes he doesn't speak for the agency. "You basically know the drug isn't cyanide. You don't know much else," says Graham, who was the whistle-blower in the 2004 Vioxx heart disease scandal. Industry-funded trials are four to five times more likely than independent studies to show effectiveness for a drug, he says.

According to a research review published in February, 90% of drug-company-funded studies come up with findings that support the company's drug.

In head-to-head research testing more than one atypical anti-psychotic drug, the outcomes are contradictory, coming down on the side of whichever company is paying for the research. (The research included studies of Risperdal, Zyprexa, Clozaril and Geodon, but none on Seroquel or Abilify.)

"It appears that whichever company sponsors the trial produces the better anti-psychotic drug," writes lead author Stephan Heres of the Technical University of Munich in the American Journal of Psychiatry.

And the short-term, smaller studies required of companies rarely detect any but the most glaring problems, Graham says.

"The American public is operating under the illusion that a drug is safe just because it's approved by the FDA," says Jeffrey Lieberman, chairman of psychiatry at the Columbia College of Physicians and Surgeons in New York. Studies lasting a few weeks to a few months, with a couple of thousand patients total, won't reveal all that's wrong with a drug, he says.

Laughren agrees that "it's very difficult to answer every question we'd like to answer with these studies, because obviously they're not huge. Sometimes bad things that happen are going to be discovered only when a drug is used more widely."

He says he, too, shares concern about the anti-psychotics prescribed for children without proof of safety or effectiveness. Much more pediatric information on the atypicals will be available within five years, he says.

Recommended changes

Others favor fundamental changes to get the needed facts about drug safety. Lieberman thinks one solution would be for the FDA to be given a new legal authority: the right to require drug companies seeking to gain approval of a drug to contribute to a collective pool at the National Institutes of Health. The NIH could supervise larger safety and effectiveness studies of medicines after they're on the market.

A national electronic medical records database that would capture all bad side effects of drugs, and require ages and diagnoses, could do a lot to protect children from careless prescribing and reveal the effects of anti-psychotics, Duke's March says.

"We know so little about what's happening to all the kids who are getting these powerful anti-psychotics," he says.

March also thinks more private insurers ought to insist that aggressive children with short fuses try non-drug therapies proven to help before doctors jump in with anti-psychotics. These pills can seem like an appealing "quick fix," he says, so they're popular.

For foster children with mental health problems, medication is a mainstay, says Ira Burnim, legal director at the Bazelon Center for Mental Health Law, an advocacy group for those with mental disabilities. There's proof that the most effective care is "wraparound," he says, meaning that caseworkers touch base regularly with a child's school, doctor, foster and perhaps birth families, in addition to ensuring therapy or medication as needed.

"Now they're medicating many kids instead of giving them the services they need. But there's very little time spent with psychiatrists and not much attention paid to side effects from these heavy drugs," Burnim says.

States vary in how much wraparound care they provide for foster kids, "but a typical pattern is patches here and there," Burnim says. "They rely heavily on medications like the anti-psychotics. This costs more than wraparound in the long run, and it's less safe for the kids."

March considers the widespread use of anti-psychotics on children without proof of safety or effectiveness "a very large experiment." Many kids are getting the short end of the stick, he says. "We're not even gathering good data on the outcome of the experiment. It's the worst of all possible worlds."

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