The Medicated Child

WRITTEN, PRODUCED AND DIRECTED BY
Marcela Gaviria

CO-PRODUCER
Will Cohen

ANNOUNCER: In 2001, FRONTLINE reported on the dramatic rise in the number of children being given behavior-modifying medications.

EXPERT: We cannot as a nation continue to play the game of Russian roulette with our children's lives.

PROTESTERS: Leave our kids alone! Don't label our kids! Don't drug-

NARRATOR: The medications were the subject of fierce debate. Today, the concerns over medicating kids continue.

911 OPERATOR: 911.

MICHAEL RILEY: My daughter passed away in the night!

911 OPERATOR: What's going on? How old is she?

MICHAEL RILEY: Our daughter passed away!

ANNOUNCER: And now one million children have been diagnosed with a new and controversial diagnosis.

JESSICA: I have bipolar, but taking my medication makes me more like I'm supposed to be.

ELIZABETH: In the morning, she takes two Trileptal. Jessica can't live without medication.

ANNOUNCER: The drugs used to treat it are powerful.

ROBERT TEMPLE, M.D., Food and Drug Administration: These are not benign drugs. You don't use them lightly.

ANNOUNCER: And many are untested.

CHRISTINA KOONTZ: It is a little worrisome to me because he is so young.

ANNOUNCER: Tonight on FRONTLINE, The Medicated Child.

RON SOLOMON: Hi, guys. You're all here to wish Jacob a happy 2nd birthday.

PARTY GUESTS: Happy Birthday, Jacob!

RON SOLOMON: This is all for posterity, you know, when he's president, you know, and they're, like, doing back story on his life and stuff. Speak of the devil!

PARTY GUEST: Happy Birthday, Jacob!

IRIS SOLOMON: Oh, and you're the writer, huh?

PARTY GUEST: That's why I'm not the reader.

IRIS SOLOMON: Oh, I got it. OK.

NARRATOR: Jacob's story begins in Los Angeles back in 1993. That's his dad, Ron, a scriptwriter in Hollywood, and Iris, his mother. Until Jacob was 3 years old, his parents say, he had no big problems.

IRIS SOLOMON: This is Jacob at work. What are you today, a shoemaker?

JACOB SOLOMON: Yeah.

IRIS SOLOMON: Yeah? What are you making?

JACOB SOLOMON: House!

NARRATOR: But sometime after his 3rd birthday, Jacob would begin down a path taken by millions of American children. It started when a teacher suggested he was hyperactive.

RON SOLOMON: He got kicked out of Mommy and Me's. You know, these are 2-and-a-half-year-old kids, 3-year-old kids, and they were saying he has no impulse control. And we were arguing with them, saying, "Well, what 3-year-old has impulse control?"

JACOB SOLOMON: Tuna fish! Tuna fish! Tuna fish!

NARRATOR: In pre-school, another teacher suggested medication.

IRIS SOLOMON: Her opinion was that there was a chemical situation going on with this child that maybe medication could help. But we thought, "A 4-year-old?" I mean, you know, why put him on pharmaceuticals at age 4?

RON SOLOMON: He's just a little boy.

IRIS SOLOMON: He's a little kid.

NARRATOR: For a year, the Solomons resisted medicating Jacob, but teachers persisted. Finally, Jacob's parents took him to a doctor.

IRIS SOLOMON: Regular smile!

NARRATOR: Jacob was diagnosed with attention deficit hyperactivity disorder - ADHD - and prescribed Ritalin.

JACOB SOLOMON: Can I try it, please?

RON SOLOMON: You know what? We're not going to give you the camera.

NARRATOR: The Ritalin helped with the hyperactivity, but it made him anxious.

JACOB SOLOMON: I just want to hold the videotape for one minute!

RON SOLOMON: And so then we'd end up giving him a second medication to deal with the anxiety. And then the second medication would cause something else, some compulsive behavior, or a tic. And then they'd say, "OK, give him a third thing." And so finally- it was like that whole- there was an old lady who swallowed the fly. And then the fly- she had to swallow the spider to get rid of the fly. And then she had to swallow a mouse to get rid of the spider. That's what the meds were like.

IRIS SOLOMON: Can you say "Happy Birthday, Teresa"?

JACOB SOLOMON: Happy Birthday, Teresa.

IRIS SOLOMON: Can you sound a little more excited?

NARRATOR: At age 9, Jacob was diagnosed with a mood disorder. Doctors tried drug after drug- stimulants, antidepressants and antipsychotics. By age 10, he had been given eight different medications.

RON SOLOMON: It all started to feel out of control, so we decided that we wanted to just strip him off of everything. We had no idea how we got on as many meds as he was on. So we just made a decision, "We've got to- we've got to pull it back. We've got to sort of strip it out and see what we actually have here."

NARRATOR: Jacob was hospitalized and taken off all his medication. But he was about to be given what was at the time a new and controversial diagnosis for a child, bipolar disorder.

RON SOLOMON: They stripped him down off of everything. And then within 24 hours, they turned around and said, "He's bipolar. He needs to take Lithium." There was no, like, "Well, isn't there therapy?" Nowhere we ever turned was there this therapeutic solution. There was nobody ever said, "Well, we can work with this through therapy," and things like that. Everywhere we looked, it was, "Take meds, take meds, take meds."

NARRATOR: Then suddenly, on the morning of his 13th birthday, Jacob woke up with a stiff neck and started rolling his head, a possible side effect of all the medication he'd been taking.

IRIS SOLOMON: Most of these doctors were experimenting. They had no clue and were just saying, "Try this, try this." There's nothing worse than seeing your kid, you know, go through something like this.

NARRATOR: Over the last 10 years, there's been a steep rise in the diagnosis and treatment of childhood mental illnesses of all types- ADHD, depression, autism and anxiety disorders. But the biggest controversy has been in the diagnosis of bipolar. Formerly called manic-depression, it was long believed to exist only in adults.

The diagnosis of childhood bipolar grew out of a series of studies by a group of child psychiatrists at Massachusetts General Hospital led by Dr. Joseph Biederman. He theorized that many children with attention deficit hyperactivity disorder were actually misdiagnosed.

LAWRENCE DILLER, M.D., Author, Running on Ritalin: In 1996, an article is published that announced that 23 percent of an ADHD population also meet criteria for bipolar disorder, OK? This was an astonishing announcement that caught most of us quite by surprise because the notion that even a teenager could be diagnosed bipolar was very, very rare.

DAVID SHAFFER, M.D., Chief, Child Psychiatry, Columbia Univ.: What he did was he took the written criteria for attention deficit disorder and he took the written criteria for bipolar disorder and he said, "Hey, a lot of these kids that you call ADHD actually fit the criteria for bipolar disorder," which I think attracted a whole lot of people. Then all of a sudden, out of nowhere, bipolar disorder suddenly was being diagnosed left, right and center.

[www.pbs.org: More on childhood bipolar]

NEWSCASTER: Our big story at 6:00, the dramatic increase in the number of kids being diagnosed as bipolar.

NARRATOR: Since Dr. Biederman and his colleagues published their findings, there has been a 4,000 percent increase in the number of children diagnosed with bipolar.

PHYSICIAN: The question is, should we call them bipolar? And should we be giving them three different medicines when they're only 2 years old? And I can tell you that's happening all over the place when they're 2!

STEVEN HYMAN, M.D., Fmr. Dir., National Inst. of Mental Health: The rates of bipolar diagnoses in children have increased markedly in many communities over the last five to seven years. I think the real question is, are those diagnoses right? And in truth, I don't think we yet know the answer.

DAVID SHAFFER, M.D.: What you've got out there is a whole lot of kids who've been diagnosed with a condition that hasn't really attained respectability yet, and they're receiving medications that have not been fully tested in children.

NARRATOR: Today there are one million kids being treated for bipolar, more and more of them at younger and younger ages.

This is D.J. Koontz. He's 4 years old. His doctor believes he's bipolar.

CHRISTINA KOONTZ: Why don't you come take your medicine?

D.J. KOONTZ: I miss my Chubbies!

CHRISTINA KOONTZ: D.J. takes Focalin extended release in the morning, a dose of Focalin in the afternoon, Clonodine to sleep at night, and Risperdal to quiet his tantrums.

NARRATOR: Bipolar in adults has traditionally been treated with drugs like Lithium. Now there are new antipsychotic drugs called atypicals.

CHRISTINA KOONTZ: It's a little worrisome to me because he is so young. You know, I don't know what the long-term side effects are going to be for him. I do know if he didn't take it, though, I don't know if we could function as a family. It's almost a do-or-die situation over here.

NARRATOR: One of the drugs D.J. is taking, Risperdal, is an antipsychotic commonly used on bipolar kids. It's known to cause tics, drooling and incessant eating.

CHRISTINA KOONTZ: He's just insatiable, hungry all the time. So whatever you put in front of him, he'll eat and then he'll just- he'll want to keep going and going and going. Their stomach never tells their brain it's full. So he could be stuffed and he'll still want to eat because he thinks he's hungry.

D.J. KOONTZ: I'm going to eat the Goldfish.

CHRISTINA KOONTZ: Goldfish and cookie?

D.J. KOONTZ: Yeah. And Gatorade.

CHRISTINA KOONTZ: And Gatorade.

D.J. KOONTZ: And another Gatorade.

CHRISTINA KOONTZ: And another Gatorade.

D.J. KOONTZ: And another corn dog.

CHRISTINA KOONTZ: And another corn dog.

NARRATOR: Some kids gain up to 100 pounds on antipsychotics and go on to develop diabetes. Christina says that despite the risks, they had no other choice.

CHRISTINA KOONTZ: He loses total control. And it's- it's scary. He's had rages that'll go half the day. He'll even sit on the floor and howl or make almost animalistic noises.

DERON KOONTZ: And hit himself.

CHRISTINA KOONTZ: Hit himself, hit his head on the wall. He'll go after anyone that's around him.

D.J. KOONTZ: I have hot medicine. I have hot medicine. I have hot medicine.

NARRATOR: There are also more unusual repetitive behaviors that D.J.'s drugs haven't changed.

D.J. KOONTZ: -medicine. I have hot medicine. I just have hot medicine, hot medicine!

MARCELA GAVIRIA, FRONTLINE: Hot medicine?

D.J. KOONTZ: Yeah.

NARRATOR: Christina says life with D.J. is still a roller-coaster. When the medications wear off, his old behavior returns.

D.J. KOONTZ: [screams]

CHRISTINA KOONTZ: D.J., no! Stop! Stop!

[in car] D.J.?

D.J. KOONTZ: What?

CHRISTINA KOONTZ: We're going to go see Dr. Bacon. What do we go to Dr. Bacon for?

D.J. KOONTZ: Get medicine!

CHRISTINA KOONTZ: Good job!

PATRICK BACON, M.D., Child Psychiatrist: Hey, guys.

DERON KOONTZ: Hello. How are you, Dr. Bacon?

CHRISTINA KOONTZ: Hi, Dr. Bacon.

NARRATOR: Dr. Patrick Bacon has been treating D.J.'s older brother, Michael, for ADHD. He started seeing D.J. nine months ago.

Dr. PATRICK BACON: So how have things been going?

CHRISTINA KOONTZ: Better.

Dr. PATRICK BACON: Better?

CHRISTINA KOONTZ: Better than our last visit, yeah.

Dr. PATRICK BACON: With the increase in Risperdal?

CHRISTINA KOONTZ: And extra Focalin in the afternoon.

NARRATOR: Because there are no definitive tests for any psychiatric illnesses, Dr. Bacon chooses D.J.'s medicine before he knows the diagnosis.

MARCELA GAVIRIA: How do you decide what medication to give a child?

Dr. PATRICK BACON: The things that influence what medication to give would involve, you know, my best guess about what is the diagnosis, and largely what has been tried in children that age.

CHRISTINA KOONTZ: The Risperdal seems to be quieting the tantrums, or the rages more.

NARRATOR: But with so many drugs on the market, getting the right treatment can take a long time.

Dr. PATRICK BACON: Twenty years ago, there were only a couple medications to choose from. So now we have more mood stabilizers. We have atypical antipsychotics that work pretty good for mood disorders. And it's made it easier to think, "Well, this symptom might respond to that, so let's try it."

CHRISTINA KOONTZ: The first time we gave it to him, it was switching the- you know, like turning the light switch off. You know, he completely-

Dr. PATRICK BACON: You have to experiment or let them continue to be symptomatic.

MARCELA GAVIRIA: You called it an experiment.

Dr. PATRICK BACON: It really is to some extent an experiment, trying medications in these children of this age. It's a gamble. And I tell parents there's no way to know what's going to work.

D.J. KOONTZ: I get back in the school! I get back in the school!

Dr. PATRICK BACON: An option would be to go higher still on the Risperdal, and see if that would just slow him down more, or look at a more typical mood stabilizer.

NARRATOR: On this day, Dr. Bacon is reluctant to up the dose of Risperdal because of the risk that D.J. will develop tics. Instead, he adds a fourth prescription, for Trileptal, a powerful mood-stabilizer used to treat bipolar.

Dr. PATRICK BACON: And of course, if there's a problem right away with Trileptal, like he sleeps all day long or it makes him real nauseous and what have you, give me a call right away.

CHRISTINA KOONTZ: I will. Can you say "Thank you"? Say, "Bye, Dr. Bacon."

D.J. KOONTZ: Bye!

Dr. PATRICK BACON: Bye. Nice to see you.

NARRATOR: Many child psychiatrists believe it is impossible to diagnose bipolar in a 4-year-old. There remains widespread confusion in the field. In the manual for diagnosing mental illness, the DSM, adult bipolar is clearly defined by recurring episodes of mania and depression. The manual says nothing about how to diagnose bipolar in kids, but Dr. Joseph Biederman and his colleagues argue that rapid mood swings, tantrums and what's called "explosive irritability" are the key symptoms of childhood bipolar.

DAVID SHAFFER, M.D., Chief, Child Psychiatry, Columbia Univ.: The criteria for mood disorder in children includes something called irritability, but a symptom like irritability occurs in something like 26 different diagnoses. So it probably means different things in different contexts and to different people.

KIKI CHANG, M.D., Bipolar Program, Stanford Univ.: I think a lot of the controversy has centered around the fact that our kids who have big temper tantrums- you know, a 9-year-old with a big temper tantrum who can't control himself. This happens a few times a week. Is that coming from bipolar disorder?

All right. Any other thing that you want to talk to me about or ask me about?

NARRATOR: Dr. Kiki Chang, a researcher at Stanford University, defends Biederman's criteria.

Dr. KIKI CHANG: When you take irritability to the extent that some of these children exhibited, and then when you add the other manic symptoms in there- decreased need for sleep, increased goal-directed activity, racing thoughts, all those things together- you're at least somewhere on the spectrum.

NARRATOR: But critics say all the debate and confusion has led to over-diagnosis, and many children with bipolar are being treated by pediatricians and family doctors who are less familiar with the diagnosis.

JOHN MARCH, M.D., Chief, Child Psychiatry, Duke Univ.: When you're a pediatrician and you're seeing a child every 15 minutes, it's very tempting to go ahead and add one of the atypical antipsychotics when you've got a kid who's oppositional and aggressive. So in a sense, the doctors and their patients and their parents are forced into this Faustian bargain, where everybody would like to take the time to think through the problem. But that kind of thoughtful, careful evaluation simply doesn't exist in most pediatrician or family doctor's office.

NARRATOR: Three years ago, Jacob Solomon's family moved from Los Angeles to the mountains above Denver.

IRIS SOLOMON: Tell me when you want to set this up.

JACOB SOLOMON: Now.

IRIS SOLOMON: You want to do that now?

NARRATOR: Jacob is now 16.

IRIS SOLOMON: OK. Well, open these first.

JACOB SOLOMON: Hold on. I'm looking at them.

NARRATOR: He remains on a potent mix of medicines, and he still rolls his head.

IRIS SOLOMON: Risperdal is for anxiety and moods. We tried different combinations and found that this seems to be the best combination for him right now. Every time he has a growth spurt, it changes. And which one is this?

MARIANNE WAMBOLDT, M.D., Chief, Psychiatry, Denver Children's Hosp.: So I haven't seen you in about a month, right?

JACOB SOLOMON: I don't know. I think so.

Dr. MARIANNE WAMBOLDT: So how're you doing with the nervousness right now?

JACOB SOLOMON: Pretty good.

Dr. MARIANNE WAMBOLDT: You're OK?

JACOB SOLOMON: I have a lot of things on my mind, like what am I going to do when I go back to school, what classes am I going to have.

NARRATOR: Dr. Marianne Wamboldt is chief of psychiatry at Denver Children's Hospital.

Dr. MARIANNE WAMBOLDT: So that's better?

NARRATOR: She says Jacob is one of a growing number of kids who come to her with a bipolar diagnosis and multiple prescriptions.

Dr. MARIANNE WAMBOLDT: What are you doing differently? Because this is the first time-

Jake came to me on about eight or nine medications, some of which I had never heard about being used for the purported purposes that they were being used for. So when I first saw him, my initial take was, "There's too much over-pathologizing of symptoms and over-calling them symptoms that need a medication, rather than thinking about other ways to deal with the symptoms." And the family was very open to that, and they really wanted to get him off of as many medications as they could.

So Jake, how could we measure your tics?

JACOB SOLOMON: Right now, they're about, maybe, a four.

Dr. MARIANNE WAMBOLDT: What does that mean, four?

JACOB SOLOMON: One through ten. One's, like, the best they could be, ten's the worst it could be. And it's around four. It's getting better.

Dr. MARIANNE WAMBOLDT: Sometimes tics are a side effect of stimulants. Often when you stop the stimulants, the tics go away. In Jake's case, they didn't go away. It's a tricky thing because we're dealing with developing minds and brains. Medications have a whole different impact in the young developing child than they do in an adult, and we don't understand that impact very well. That's where we're still in the dark ages.

NARRATOR: One of the few places that specializes in childhood bipolar is at the University of Pittsburgh Medical Center. The doctors here say that many of the kids referred to the clinic come in misdiagnosed, with a slew of labels.

DAVID AXELSON, M.D., Bipolar Institute, U. Pittsburgh Med. Ctr.: Maybe new cases, then, or new referrals, Tim?

INTAKE DOCTOR: Yeah, two. One is a 9-year-old. She's going into the 4th grade and has a past diagnosis of Bipolar II, ADHD, ODD, OCD.

NARRATOR: They say it can take months or even years to untangle a case and decide whether a kid is bipolar or not.

INTAKE DOCTOR: -irritability, increased sleep, tearfulness, some anhedonia-

Dr. DAVID AXELSON: One thing that's complicated is bipolar disorder is probably not a single, unitary disorder. It's probably a syndrome that's a collection of things that are related and can overlap with other child psychiatric illnesses, including ADHD, including depression.

INTAKE DOCTOR: She says these episodes can last one to two days.

Dr. DAVID AXELSON: There is a risk of this being something that is a label that's given inappropriately. So we have to be very careful and cautious about diagnosing a child with this illness.

INTAKE DOCTOR: But she has verbalized some suicidal ideations?

Dr. DAVID AXELSON: Yeah, it sounds like a good kid for us to see.

We're barely getting started at figuring out what might be wrong in these kids' brains. You know, the brain's extremely complicated, and it's going to take us a long time to figure out these problems.

[www.pbs.org: The difficulty of accurate diagnosis]

JESSICA: And I wanted that!

Dr. DAVID AXELSON: You would have what?

NARRATOR: Dr. David Axelson believes it is a rare case that is clear-cut.

Dr. DAVID AXELSON: Why? How come you wanted to bust your head open?

JESSICA: Because I wanted-

NARRATOR: But in September of 2000, he was referred a 5-year-old patient, Jessica.

Dr. DAVID AXELSON: Now, when you were in Wal-Mart, was this sort of a normal kind of happy feeling, or was it kind of different than just having fun?

NARRATOR: She arrived at his office displaying textbook symptoms of adult bipolar, including grandiosity and euphoria. Dr. Axelson was so intrigued that he videotaped the session.

JESSICA: I was trying to fool those two!

Dr. DAVID AXELSON: You were trying to fool them? What were you trying to do to fool them?

JESSICA: I was trying to take their head away and fool them.

Dr. DAVID AXELSON: Trying to take their what?

JESSICA: Their head away!

Dr. DAVID AXELSON: Trying to take their head away. How could you do that?

JESSICA: I can just get a knife and go-

Dr. DAVID AXELSON: Really? And you wanted to do that to your folks?

JESSICA: [nods, giggles]

Dr. DAVID AXELSON: The interesting thing about Jessica is that she did really present in the office with symptoms- a great deal of aggression and morbid thoughts and grandiose thinking that she could do anything.

JESSICA'S FATHER: Just jumping off of everything, climbing on everything-

Dr. DAVID AXELSON: In addition, she had a very clear two to three-week period of depression. You know, she was not caring for herself, not getting out of bed. She was just sort of staring at the wall.

ELIZABETH: She didn't want to eat. She didn't want to do anything. She wasn't angry anymore, she just wanted to crawl up in a ball and have the TV on and not move.

NARRATOR: Jessica was diagnosed with Bipolar 1, the classic form of the disorder. Its hallmark symptom: expansive, grandiose thinking.

JESSICA: I could even lift them up and put them on the roof and bust their heads open!

Dr. DAVID AXELSON: I see. OK. Lots of talk about busting heads open, huh?

JESSICA: [nods]

Dr. DAVID AXELSON: How're you guys doing?

ELIZABETH: Good.

Dr. DAVID AXELSON: Hey, Jessica, good to see you. Come on back.

NARRATOR: Jessica is now 12 years old. Dr. Axelson still believes she's a clear-cut case of bipolar.

Dr. DAVID AXELSON: And how would you say your mood has been over the past few weeks?

JESSICA: Pretty good. I cry and scream a lot, though.

Dr. DAVID AXELSON: You do? And that's kind of a change compared to a few months back, I would say. Has something been bothering you, do you think, in particular? Or has something been on your mind or worrying you?

JESSICA: [nods]

Dr. DAVID AXELSON: OK.

JESSICA: This girl at school, I'm worried about what she's going to say when I go back to school, what she's going to do, because she's really mean.

NARRATOR: On top of Jessica's worries about school, Jessica's dad has just been deployed to Iraq.

Dr. DAVID AXELSON: Does it make you sad, thinking about it some? That's totally normal.

JESSICA: [cries]

Dr. DAVID AXELSON: There you go.

ELIZABETH: It's OK to be sad.

NARRATOR: In the midst of all this, Dr. Axelson has to sort out what are normal childhood stresses and what are the actual symptoms of bipolar disorder that need medication.

Dr. DAVID AXELSON: You know, there's no scientific answer here about what to do. I think we should try to go up a little bit on the medicine. This is definitely more than just her usual- you know, a usual reaction to the stress, and we don't want to go into school with things being pretty rocky.

JESSICA: OK.

Dr. DAVID AXELSON: Does that sound like a plan?

JESSICA: Some people just don't understand that I have bipolar. It's kind of hard. But as long as I'm taking medication, then I'll be fine. It's the only way to keep me settled down. Taking my medication makes me more calmer, more like- like I'm supposed to be.

ELIZABETH: We're talking about putting a small child on these heavy medications. She can't go a day without medication. It's a big burden for her. She may not feel it now, but I feel it for her. And I wish she didn't have to do any of it.

JOHN MARCH, M.D., Chief, Child Psychiatry, Duke Univ.: If you ask me what is the greatest challenge facing American child psychiatry right now, it's in the area of bipolar illness. How should we treat it? We have to know the answer to that question. Are the treatments that we- we use safe for the brain or deleterious? And the tragedy is not that this question's being asked, the question is that we're not generating the data which will give us the answer.

NEWSCASTER: Virtually all of the drugs approved by the Food and Drug Administration are tested solely on adults. That leaves pediatricians mostly guessing, says Danny Benjamin.

NARRATOR: In Washington, officials at the Food and Drug Administration have been aware for years of the lack of research. There were not only few studies on psychiatric medications prescribed to children, but on all childhood medicines, from cough syrup to ear drops.

DIANNE MURPHY, M.D., Food and Drug Administration: Parents need to be aware that all products haven't been studied in children. As a matter of fact, I'd say too high a percentage of time, we don't know what we're doing, and we need to study it in kids and get the dosing right and know whether it works in them.

NARRATOR: But drug makers have long been reluctant to run clinical trials on children.

ROBERT TEMPLE, M.D., Food and Drug Administration: For a number of reasons, it was difficult to get companies to do studies in children. People are always nervous when they do studies in children. There's reluctance sometimes to leave them untreated and use a placebo. But with one thing and another, there were very, very few studies in children.

Pres. BILL CLINTON: The rule I announce today will put an end to this guesswork. It will require manufacturers of all medicines needed by children to study the drug's effects on children.

NARRATOR: Then in 1997, the Clinton administration offered the pharmaceutical industry lucrative patent extensions as an incentive.

Dr. ROBERT TEMPLE: The incentive is very powerful for a drug company. If they do the pediatric studies that we ask them to do, if they do them and do them with integrity, they get six months of additional exclusivity. That means protection against the generic drug. Well, for a drug that sells a lot, like most antidepressants or something like that, that's worth a lot.

NARRATOR: A single extension can be worth more than a billion dollars. As a result, the pharmaceutical companies have launched over 200 studies of childhood medicines. As the research has come in, it's become clear that many of the drugs that work in adults do not work well - or at all - in children.

Dr. Andrew Leon of Cornell University was asked by the FDA to review the data on antidepressant drugs like Paxil and Effexor.

ANDREW LEON, Ph.D., FDA review panel, 2004: I have to say I was rather alarmed. I'd never seen how few of those trials had been positive, had shown that the antidepressants were more effective than placebo in kids. The clinical lore would have you believe that these antidepressants were very effective in kids, but the data didn't support that.

BENEDETTO VITIELLO, M.D., National Institute of Mental Health: Children are not just young adults. They react to medication in a different way. They can be more sensitive to certain side effects of medication. Sometime medications don't work in children. So it's not right, it's not safe to take information that we know in adults and try to apply them in children.

NARRATOR: The antidepressants not only failed to work. Some children had serious reactions.

1st PARENT: My daughter, Cecily, had only been taking Paxil for two weeks before she died.

NARRATOR: In 2004, the FDA held several public hearings.

2nd PARENT: My 16-year-old stepson, Brandon Ferris, committed suicide on July 22nd, 2001, about three weeks after he began taking Zoloft.

NARRATOR: The FDA concluded that 4 percent of kids had an increased risk of becoming suicidal.

3rd PARENT: She died of suicide at the age of 12 years, 3 months, just eight weeks after being put on Paxil and then Zoloft.

NARRATOR: The FDA's strongest warning, a black box, was put into effect. It made big news.

NEWSCASTER: The federal government today moved to warn parents in no uncertain terms-

NARRATOR: The reports alarmed doctors and their patients.

NEWSCASTER: They can sometimes trigger suicidal behavior in children and teenagers.

Dr. BENEDETTO VITIELLO: If the black box warning led to more attentive use of this medication, more attention to diagnosis, more attention to side effects, better monitoring during treatment, that was a good thing. If it discouraged treatment of people who needed that, of course, was a bad thing.

NARRATOR: It did discourage some. Since concerns were first raised, prescription rates for antidepressants declined and the suicide rate jumped, leading many psychiatrists to fear that kids who needed antidepressants were no longer getting them.

MARCELA GAVIRIA, FRONTLINE: How did you feel about the black box label being put on antidepressants? Did it seem like a good idea?

Dr. ROBERT TEMPLE: The black box was never intended to say, "Don't use these drugs in children." It didn't say that. We recognized that some people might read the black box and be scared off and not treat people. We were conscious of the fact that, by most studies, the rate of adolescent suicide appeared to be declining as these drugs had come along. We were nervous about that, but we felt we had to tell people anyway.

NARRATOR: The black box warning appears to have had another unintended consequence. In the confusion over the safety of antidepressants for kids, some doctors turned to antipsychotic medications to treat depression.

TOM INSEL, M.D., Dir., National Institute of Mental Health: We are seeing an increase in the use of atypical antipsychotics, especially in children. And one thought is that those are being used in place of the antidepressants. And in a sense, what we've done is we've taken a drug that has very limited risk and replaced these drugs often with a class of drugs that have unknown efficacy but quite well known risks. And I'm not sure that that's progress.

MARCELA GAVIRIA: The end result is that a very well studied medication has a black box warning that is very severe.

Dr. ROBERT TEMPLE: Again-

MARCELA GAVIRIA: And that the very dangerous drugs out there, like atypicals, that are being used in kids, don't have this black box warning. That strikes me as ironic.

Dr. ROBERT TEMPLE: The atypicals have a very strong warning against something we know they shouldn't be used for, which is demented elderly people. But our trouble is when you have fundamentally an absence of data, which is largely the case for children, it's hard to write a box.

MARCELA GAVIRIA: But you're the FDA. People look at you to sort of figure out, you know, what- what is the right thing to do for my child.

Dr. ROBERT TEMPLE: Yeah. But we- but when there's no data, we can't tell them.

[www.pbs.org: More on the lack of data on drugs]

911 OPERATOR: 911.

MICHAEL RILEY: Can I get an ambulance? My daughter passed away in the night!

911 OPERATOR: What's going on? How old is she?

MICHAEL RILEY: My daughter passed away!

911 OPERATOR: How old?

MICHAEL RILEY: She's 4.

911 OPERATOR: All right. We'll be right there.

NARRATOR: The danger of prescribing untested drugs to young children grabbed national attention a year ago. Rebecca Riley of Hull, Massachusetts, had been diagnosed with bipolar and was taking a mixture of psychiatric medications.

FRONTLINE was visiting the Koontz family when they learned of the case.

KATIE COURIC, 60 Minutes: We went to talk to one of the leading proponents of the diagnosis of bipolar disorder in children. He is Dr. Joseph Biederman.

Now you're saying up to a million children are running around with this-

Dr. JOSEPH BIEDERMAN: Correct. Correct.

KATIE COURIC: The autopsy revealed that she had died from an overdose of psychiatric drugs.

NARRATOR: The Koontzes worried that D.J. was on a similar regimen of psychiatric drugs, including the sedative Clonodine.

CHRISTINA KOONTZ: It terrified me, especially to hear there was enough Clonodine in her system alone to kill her.

KATIE COURIC: This is what her pre-school teacher said, that she was like a floppy doll, so tired she had to be helped off the bus.

CHRISTINA KOONTZ: I mean, to think there's something on my counter that he takes on a daily basis, that the little girl had so much in her system that that alone could have been the cause of her death, terrified me.

DERON KOONTZ: I mean, neither one of us are supporters of medicating our kids. You know, that's not why we do this. We do it because we've discussed it with the doctor and it seems to work.

NARRATOR: The Koontzes went back to Dr. Bacon's office to see if they could lower D.J.'s medications.

Dr. PATRICK BACON: So how are you guys doing?

CHRISTINA KOONTZ: Good. Good.

Dr. PATRICK BACON: Have things been going pretty well?

CHRISTINA KOONTZ: [nods]

Dr. PATRICK BACON: Good.

CHRISTINA KOONTZ: I watched 60 Minutes, and it made me think and wonder, is there anything not medication-related that we need to be doing for D.J.? I mean, is there any type of classes? Is he too young for therapy? I mean, would any of that benefit him along with the medication?

Dr. PATRICK BACON: At this point, I think it's, like, 99 percent medication. Plus, it's harder for him to make use of therapy and to make use of any behavioral program if he's still got a lot of symptoms that he really can't control, even if he tried.

CHRISTINA KOONTZ: OK. I just want to be sure that we're doing absolutely everything that we possibly can.

Dr. PATRICK BACON: Yeah. How are things going for him in school?

CHRISTINA KOONTZ: He likes it, once he gets there. The anxiety getting there is a two-hour battle.

Dr. PATRICK BACON: Oh, really.

CHRISTINA KOONTZ: Crying and "Please don't make me go to school, let me stay home." But as soon as we walk in the door, he hangs his backpack up and he's fine the rest of the day.

Dr. PATRICK BACON: OK. Sometimes, also what we'll do is try just a little bit of an anti-anxiety medication, like, in the morning, something like Xanax. And again, it's a tradeoff. You know, do you want to see if that will work, or do you want to try and coax him into it?

CHRISTINA KOONTZ: I think I want to suffer through for a little bit before we add another one because once he gets there, he's OK.

Dr. PATRICK BACON: And my hope would be, as we go up on the Trileptal, that anxiety will go down quite a bit. And I've seen that happen, so- but let me write you that prescription for the Focalin, and then we'll go from there.

[www.pbs.org: Watch this program again on line]

NARRATOR: D.J. left Dr. Bacon's office with the recommendation to up his dose of Trileptal.

Many psychiatrists continue to follow the lead of Dr. Biederman. FRONTLINE wanted to speak to him, but he has stopped talking to the media.

Dr. JOSEPH BIEDERMAN: We published a paper in The American Journal of Psychiatry examining ADHD with or without bipolar disease, and-

NARRATOR: His office recommended that we speak instead to Dr. Chang at Stanford.

KIKI CHANG, M.D., Bipolar Program, Stanford Univ.: I'm really excited about medications. People are so concerned about the side effects that they have on children, but one thing that people often overlook are the possible beneficial side effects, if you will.

How did the movie make you feel?

NARRATOR: Dr. Chang himself has lately been pushing one of the more provocative ideas in child psychiatry.

Dr. KIKI CHANG: How about the thoughts in your head, and things like that?

HOLT ROULAND: They race through- they race through so fast. I can't even think of them...

NARRATOR: He believes he can prevent bipolar disorder by identifying and medicating children at risk before they develop full-blown symptoms.

HOLT ROULAND: I don't know. It depends on the day. Sometimes it can take three hours, sometimes it can just be half an hour.

Dr. KIKI CHANG: The theory is that if you get in early, before the first full mood episode, before too much has kindled in the brain, then perhaps we can delay the onset to full mania. And if that's the case, perhaps finding the right medication early on can protect a brain so that these children never do progress to full bipolar disorder.

NARRATOR: Bipolar is known to run in families. In order to identify these kids early on, Dr. Chang is relying on MRIs.

Dr. KIKI CHANG: We're going to get started now. Squeeze the ball if you're ready. All right. Great.

NARRATOR: He's zeroed in on a cluster of neurons located deep within the brain called the amygdala. The amygdala is thought to store a person's emotional memory.

Dr. KIKI CHANG: What we've been finding is that in kids with bipolar disorder, these amygdala are significantly decreased in volume compared to healthy kids. They're smaller. Doesn't mean yet that we can use it to diagnose bipolar, but it gives us a pretty good head start in saying, "OK, you know what? This is a very important region. Why is it smaller? Let's find out. Let's investigate it further."

NARRATOR: Dr. Chang is also researching how the brain responds to antipsychotic medications.

Dr. KIKI CHANG: -on the use of atypical antipsychotics in pediatric bipolar disorder-

NARRATOR: At this year's annual convention of child psychiatrists, he presented the results of three new studies on antipsychotics.

Dr. KIKI CHANG: This is a very exciting area-

NARRATOR: Dr. Chang says the early results are encouraging.

Dr. KIKI CHANG: Five years ago, we would have practically no data to give you. We now have reliable large-scale trials to be able to present to you, and some of these are hot off the press.

NARRATOR: But critics point out that researchers who advocate the use of psychiatric medications, like Chang and Biederman, receive enormous support from drug companies. And they believe that these industry-funded studies unduly influence doctors' decisions.

Prof. DANIEL CARLAT, M.D., Psychiatry, Tufts Univ.: Whenever research is funded by industry, unfortunately, the research is always going to be suspect. There's no question that from the standpoint of any psychiatrist looking around at the courses that are being offered, going to the large meetings, reading the journals, that just about everything bears the stamp of drug industry funding and drug industry influence. And it is really one field where it's extremely hard to know who you can trust and who you can't trust.

Dr. KIKI CHANG: Very exciting as well, our disclosures. And as you can see here, I have various relationships with these companies.

Dr. KIKI CHANG: I think it is an uneasy partnership. But I think that without them, where would we be now? We wouldn't have any of these studies now.

MARCELA GAVIRIA: And yet you call it an uneasy relationship.

Dr. KIKI CHANG: It is uneasy because there is a potential conflict of interest and definitely that perceived conflict. even if there isn't a conflict of interest, meaning that, "Hey, we're going to do our own studies ethically," and we do. But somebody reading the study may say, "Oh, they received funding from this pharmaceutical company to do the study. Therefore, the results may be biased." So that is a problem.

[www.pbs.org: Read Dr. Chang's extended interview]

NARRATOR: Meanwhile, as Dr. Chang continues to pursue answers, others are already claiming to have solutions.

This is Matthew Detrick. His parents are concerned about his moodiness. For nearly $3,000, this diagnostic center claims that it can identify undiagnosed conditions and help determine the best medication. But this machine is not like Dr. Chang's. It only measures blood flow patterns in the brain. And it's located on a commercial strip in Denver, at a company called Brain Matters.

NANCY GOODHUE, Co-founder, Brain Matters, Inc.: So now what we're going to do is talk about the results from your brain scan, OK? Are you excited? Are you nervous?

MATTHEW: No.

NANCY GOODHUE: No, you're not nervous at all? Good. So this is called the transverse view and-

NARRATOR: At Brain Matters, they believe their doctors can link blood flow changes to behavior problems. Matthew's results are explained by Nancy Goodhue, a social worker.

NANCY GOODHUE: Deep in your brain, Matthew, in the middle, middle part of your brain, it's called the thalamal limbic area, and that's where your emotions live. So this area here, the thalamal limbic area, should be yellow and light brown. And for you, it's red and white and a little bit black. So this is something that, because of the pattern, it's suggesting to our doctor that Matthew might have some trouble with mood. So the recommendation is for some medicine that actually stabilizes the mood.

NARRATOR: The family is impressed.

MATTHEW'S FATHER: I think they've done a great job explaining what the results are. I don't really understand the medical terms that are being used, but I think it's pretty much on target.

NANCY GOODHUE: And so we really have an opportunity to influence his brain between now and the time he's 25. He's 11 right now.

MARCELA GAVIRIA: Do you think that it's raising false expectations?

NANCY GOODHUE: You know, I really hope not. I think, compared to the interview, the diagnostic interview and the paper and pencil test that we've had so far, this is just so far and away better. Even though it's not conclusive, it's much, much better than what we've had historically.

NANCY GOODHUE: So these little yellow areas here, on the under side-

JOHN MARCH, M.D., Chief Child Psychiatry, Duke Univ.: We all want a simple, easy solution for these complicated life problems. My view, to put it very simply, is if it's too good to be true, it is, in fact, unfortunately, too good to be true.

Dr. KIKI CHANG: We're at least five to ten years, if not more, off from that being a really reliable clinical tool. Right now, it's strictly a research tool.

NARRATOR: But Brain Matters has already reached millions, now with centers in Los Angeles and Seattle, and has been featured twice on Dr. Phil.

BRAIN MATTERS DOCTOR: We can see the bipolar pattern much earlier in someone's brain-

NANCY GOODHUE: Meaning those areas on the top of Fred's head do not receive the right blood flow.

NARRATOR: Brain Matters is just one example. There is now a cottage industry of diagnostic centers, self-help books, Internet sites and nutritional regimens profiting from parents' desperate search for solutions.

In 2001, when FRONTLINE first reported on medicating children, the chief of ADHD research at the National Institute of Mental Health was Dr. Xavier Castellanos. He acknowledged then that brain science was in its infancy.

[www.pbs.org: Watch "Medicating Kids" (2001) on line]

XAVIER CASTELLANOS, M.D., National Institute of Mental Health: The brain is the most complex thing we know, changing, rewiring itself. And so what we measure are very crude, preliminary things. But we've only been at it for about 10 or 12 years. We don't yet have our Einstein.

NARRATOR: Dr. Castellanos is now the Director of Research at the Child Study Center at NYU. We went back to see him to ask if there was a solution to the lack of knowledge about today's psychiatric medications.

Dr. XAVIER CASTELLANOS: I desperately need to know, personally, what in the world these things are about, and I can't figure it out.

NARRATOR: We found him brainstorming with other neuroscientists.

NEUROSCIENTIST: So are you entering all of the co-variants simultaneously, or are you taking-

NARRATOR: Once a year, they meet and try to solve some of the biggest questions in the field.

NEUROSCIENTIST: That really complicated the results and-

Dr. XAVIER CASTELLANOS: Why should the brain invest so much caloric energy in-

MARCELA GAVIRIA: You used to say you hadn't quite found your Einstein.

Dr. XAVIER CASTELLANOS: Well, I think that we're probably not looking for an Einstein, although it'd be great if one showed up. But I've changed my metaphor slightly, and now I'm thinking more about a kind of group project.

NEUROSCIENTIST: He found that these resting EGA symmetries in alpha were predictive of task performance.

NARRATOR: Dr. Castellanos now advocates doing what pediatric cancer specialists did in the 70s. Back then, childhood cancer was an almost certain death sentence.

NEUROSCIENTIST: Once again, those are the anti-matter, a constant question-

Dr. XAVIER CASTELLANOS: The model is there. Every child with cancer in this country is part of a study. You can't get treated otherwise. Pediatric oncologists got together and said, "We can't do this one by one. We have to form these associations."

NARRATOR: By networking and comparing treatment regimens, doctors learned what worked and what did not. The system is still in place today.

Dr. XAVIER CASTELLANOS: We've been able to turn this around so that now it's at least a 90 percent cure for childhood cancers. And that's a huge turnaround.

JOHN MARCH, M.D., Chief Child Psychiatry, Duke Univ.: Everything that happens in the clinical treatment of kids with cancer is set up in such a way that you learn something. You learn something about what cancer is and how it should be treated. Think about the extraordinary public health impact of making that kind of principled commitment. That's what's missing. And in my view, it's scandalous.

THERAPY VIDEO: The key to conscious relaxation is the simple act of observing and accepting the present state of your body mind and your environment.

NARRATOR: In the fall of 2007, FRONTLINE revisited Jacob Solomon.

THERAPY VIDEO: From there, externally rotate the thighs with the use of your hands and come back to center.

NARRATOR: His psychiatrist believes this alternative therapy might help reduce his reliance on medication.

THERAPY VIDEO: Continue to feel the external rotation of the thighs.

JACOB SOLOMON: My thing is, I've been on eight medications at one time. I don't want to do that again. I want to get down to the lowest amount that I can. The lowest.

MARCELA GAVIRIA: Do you think you'll always be on meds?

JACOB SOLOMON: Possibly. I really don't know. I really don't know. I want to know, but I don't.

NARRATOR: At school, he struggles academically. He still has bipolar and ADHD diagnoses, but has to be careful about his medications because they can make his tics worse. But he has a new best friend, and he just got his learner's permit. All in all, Jacob's parents say this might be the best it's ever been.

RON SOLOMON: He's started to see a psychologist a couple times a week, and we can already see it making a difference in helping him. He is at a good point, and we can see him starting to take a little bit more control of who he is. And that makes us really happy.

IRIS SOLOMON: Oh, yeah.

NARRATOR: Jessica is now in 6th grade and is doing well in school. But in the last few months, her mood swings have gotten worse. Her mother says, she's not sure whether this is caused by her bipolar, her medications, or just the fact that her 13th birthday is around the corner.

ELIZABETH: With a little girl, you think of first prom and you think of beautiful weddings and you think of sending them to college. And you have to learn to put your dreams aside and really accept your child for exactly who they are. And whatever she can do, she'll do.

MARCELA GAVIRIA: Do you think she'll grow out of it?

ELIZABETH: No. [cries] No, she'll have to take meds for the rest of her life, if she wants to go to college or have a job or have a family. But when you think of what the hard times were and the hard times that are to come ahead for her, it's hard.

CHRISTINA KOONTZ: Come here, bubba.

NARRATOR: Since the last visit to Dr. Bacon, D.J.'s medications have been upped yet again.

CHRISTINA KOONTZ: Chew them up good.

NARRATOR: At first, Christina reported that the increase in dose didn't seem to be helping. D.J. was irritable and throwing frequent tantrums.

CHRISTINA KOONTZ: Tired?

D.J. KOONTZ: Yes.

CHRISTINA KOONTZ: Hm?

D.J. KOONTZ: Yes.

CHRISTINA KOONTZ: Ready to go to sleep?

D.J. KOONTZ: Yeah.

NARRATOR: In recent weeks D.J. has improved, and Christina still believes the medications are helping her son.

D.J. KOONTZ: [unintelligible]

CHRISTINA KOONTZ: Shhhh.

The Medicated Child

WRITTEN, PRODUCED AND DIRECTED BY
Marcela Gaviria

EDITOR
Daisy Wright

SENIOR PRODUCER
Martin Smith

CO-PRODUCER
Will Cohen

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Jon Sayers

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NARRATOR
Will Lyman

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Elizabeth & Family
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ANNOUNCER: There's much more to explore about this story on our Web site, where you can watch the program again on line, find answers to frequently asked questions about psychiatric medications for children and the bipolar diagnosis, read the interviews with some of the doctors and researchers featured in this report. And join the discussion. Share your own story about a bipolar diagnosis and the decision to medicate a child at PBS.org.

Next time on FRONTLINE:

RON SUSKIND, Author, The One Percent Doctrine: Cheney was in the front seats for the searing moments of the Nixon administration.

ANNOUNCER: He wanted to reverse history.

DAVID GERGEN, Former Presidential Adviser: Dick came out of that committed to restoring the powers of the presidency.

ANNOUNCER: It took three presidencies-

MARTIN LEDERMAN, Office of Legal Counsel, 1994-Ô02: He believes that the president should have the final word, indeed the only word.

ANNOUNCER: -and a historic event to accomplish it.

BARTON GELLMAN, The Washington Post: The president could do as he liked, even if the Supreme Court said he couldn't.

ANNOUNCER: Cheney's Law. Watch FRONTLINE.

To order FRONTLINE's The Medicated Child on DVD, call PBS Home Video at 1-800-PLAY-PBS. [$24.99 plus s&h]

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