If education officials throughout the US have ordered parents for decades to get their "disruptive" - special needs - children prescriptions for antidepressants and other drugs to "control" their behavior in class, and if researchers find that these drugs are not approved for use by young children and teenagers, and educators continue to mandate use of these drugs, can our education policymakers be liable for any consequences to the health and welfare of the children/teens taking these drugs under orders of their principals/teachers?

Antidepressants Restudied for Relation to Child Suicide
By GARDINER HARRIS, NY TIMES, June 20, 2004

A child stabs himself in the neck with a pencil. Another slaps herself in the face. Is either suicidal? It is a question that has divided psychiatrists and drug regulators the world over and goes to the heart of a fierce controversy over whether antidepressants lead some children to become suicidal.

Now four researchers at Columbia University hope to provide an answer. By reclassifying reports of suspect or self-destructive behavior that occurred during tests of antidepressants in youngsters, the research team hopes to clarify whether antidepressants lead children and teenagers to become suicidal. Officials at the Food and Drug Administration say they will use results of the study to help them decide, later this summer, whether the agency should discourage doctors from prescribing the pills to youngsters.

The study was commissioned by top F.D.A. officials after they rejected an analysis by one of the agency's top experts that concluded that antidepressants could be dangerous when given to teenagers and younger children. With such a controversial beginning, the study is being met by fierce criticism.

Senator Charles E. Grassley, Republican of Iowa, issued a statement questioning whether the study was part of an effort by the Food and Drug Administration to suppress the truth about the risks of antidepressants. Mr. Grassley said he was investigating the study as part of a larger inquiry into the agency's handling of the controversy involving antidepressants and suicide.

Some prominent mental-health research has questioned the study's methodology.

"You've asked the Columbia group to take data that's suboptimal and try to come up with a conclusion, and I really doubt that they will be able to do that,'' said Dr. Thomas R. Insel, director of the National Institute for Mental Health.

The Columbia team plans to apply a consistent definition of ''suicidal'' to a disparate collection of more than 400 reports of adverse behavior that occurred in 25 clinical tests of nine antidepressants. The tests, undertaken by drug companies, involved Prozac, Zoloft, Paxil, Luvox, Celexa, Wellbutrin, Remeron, Serzone and Effexor.

One of the problems with the drug-company trials is that they tend to confuse self-destructiveness with suicidal attempts, team members said in an interview.

"Suicide research has come up with a specific definition of suicide attempts: a self-injurious behavior where there is some intent to die,'' said Barbara Stanley, one of the researchers.

The team will give nine independent reviewers the descriptions that drug-company researchers used in reporting the cases involving adverse behavior. . The reviewers will label each event as suicidal, nonsuicidal or indeterminate, and then give the data to federal drug regulators for statistical analysis.

Discovering intent from the brief notes provided by the drug companies could be difficult. In a speech before an advisory panel in February, Dr. Thomas Laughren, leader of the F.D.A.'s psychiatric drug products group, noted that the drug companies' descriptions were often poor. "We did not have the level of detail in these cases that one would have liked to do a rational classification,'' Dr. Laughren said.

Julie Magno Zito, an associate professor of pharmacy and psychiatry at University of Maryland, Baltimore, predicted the Columbia team would not be able to overcome this problem. "If a kid pierces his neck with a pencil, that could be a violent act of self-destruction or it could have been nothing,'' Dr. Zito said. "If the notes don't make the intent clear, how do you interpret that?''

Dr. Zito called the Columbia study "a fundamentally bad idea.''

Dr. Alan Gelenberg, head of the department of psychiatry at the University of Arizona, said the study would provide a needed perspective. But even those who support the study agree that it is unlikely to change many minds on the question of whether antidepressants should be prescribed to children.

"This question will never be settled,'' said Dr. James McGough, a professor of clinical psychiatry at the University of California, Los Angeles. "Still, I'm eager to see what their answer is.''

In tackling the issue, the researchers say they understand that they are being thrust into a maelstrom rarely seen in psychiatry.

"For all of us, our anxiety levels are higher because we know that there are people invested in this one way or the other,'' said Dr. Madelyn Gould, professor of clinical public health in psychiatry. "Anything that has to do with drug treatment in kids is so emotionally charged.''

The study had its beginnings early last year when GlaxoSmithKline submitted to federal drug regulators the results of three trials of its Paxil antidepressant in teenagers and other children. The company had undertaken the studies to take advantage of a federal law that delays by six months the introduction of cheaper, generic versions of drugs when branded makers test medicines in children.

In GlaxoSmithKline's trials, depressed young people given Paxil fared no better than those given placebos. It was a disappointing result for GlaxoSmithKline but had no effect on its application for the six-month extension. Still, a reviewer at the Food and Drug Administration noticed something strange about the trials: teenagers given Paxil suffered more problems of ''emotional lability,'' or instability, than those given a placebo.

The reviewer, Dr. Andrew Mosholder, thought ''emotional lability'' was overly broad. He asked the company to resubmit its data, this time using a separate category for suicide.

That report, given in May to both American and British health authorities, was alarming. Teenagers and younger children given Paxil were much more likely to become suicidal than those given placebos. In June, both the British and American authorities warned doctors against prescribing Paxil to youngsters. Worried that the problem could extend far beyond Paxil, the F.D.A. in July asked the makers of eight other antidepressants to submit data from their studies in youngsters.

In August, Wyeth issued a warning that doctors should avoid prescribing Effexor to youngsters because it, too, seemed to cause them to become more suicidal.

By September, the agency had received the other companies' studies. Looking at them all, Dr. Mosholder concluded that children given antidepressants were almost twice as likely as those given placebos to become suicidal. He suggested the agency discourage the drugs' use in children.

It would have been a monumental step. Antidepressants are among the biggest-selling drugs in the world and have long been viewed by doctors as relatively safe. Their use in children has been soaring.

Dr. Mosholder's bosses at the Food and Drug Administration, however, said the drug company data was inconsistent and that some events termed ''possibly suicidal'' seemed innocent. Top agency officials hired the Columbia researchers to review the data, and they forbade Dr. Mosholder to speak about his conclusions to an advisory panel reviewing the matter.

The silencing of Dr. Mosholder prompted outrage among critics of antidepressants and the ongoing investigation by Senator Grassley. It also has fostered skepticism about the Columbia study. Already, Internet postings are questioning the backgrounds of the Columbia researchers. One asks whether Kelly Posner, the lead investigator, has participated in trials financed by the drug industry.

In a group interview in a conference room in the New York State Psychiatric Institute, the researchers said they were unbiased.

Dr. Posner said that she had participated in some trials sponsored by drug makers but never as a principal investigator. All of the trials involved attention deficit disorder, not depression or suicide, she said.

Her three colleagues said that they had never taken part in a drug-company trial. And they said that their study, while hugely controversial, was relatively simple: figuring out the appropriate labels to place on the behaviors in the individual cases.

"We're just dealing with a lot of pieces of paper,'' Dr. Gould said. "We're not dealing with people at all. And all the interesting questions happen once we give the data over to the F.D.A.,'' where the statistical analysis will occur.


Some parents just say 'whoa' to school-required medications;
As parents seek more legal protection, controversy over drugs' impact deepens.
By Kelly Hearn, The Christian Science Monitor, June 14, 2004

When Patricia Weathers's son Michael had problems in his first-grade class, a school psychologist told the New York mother he had attention deficit hyperactivity disorder, or ADHD, and needed to be medicated with stimulants. If not, he would be sent to a special education facility near his Millbrook, N.Y., school.
Confused and intimidated, Ms. Weathers says she consented to put Michael on Ritalin, a commonly used stimulant that doctors prescribe to decrease the symptoms of ADHD - restlessness, disorganization, hyperactivity.

But Michael exhibited negative effects from the drug, such as social withdrawal. Instead of spotting the side effects, Weathers says, school officials again pressured her back to the psychiatrist's office, where Michael's diagnosis was changed to social anxiety disorder and an antidepressant prescribed.

Finally, says Weathers, "I saw that the medicines were making Michael psychotic, so I stopped giving them to him." When she stopped the medicine, the school reported her to state child protective services for child abuse.

Though charges were dropped, the Weathers case has become a symbol of the simmering controversy surrounding attention deficit disorder/ADHD, treatment for it, and the subjective diagnostic tests some critics say has led to an overuse of stimulants in schools.

Though there is no official count of people claiming coercion, (Weathers says some 800 parents have logged complaints of similar coercion on her website www.ablechild.org), child abuse allegations appear to be infrequent, perhaps because states are moving to pass laws that to some degree limit what schools can say or do regarding ADHD and other behavioral disorders.

To date, according to activists who track the issue, seven states have laws prohibiting school personnel from recommending psychotropic drugs for children. Over the past few years, 46 bills in 28 states have either passed or are awaiting action.

Currently, one federal bill, the Child Safety Medication Act, prohibits schools from making medication a requirement of attendance and calls on the Government Accounting Office to track how often schools pressure parents to seek ADHD diagnoses. It passed the House in 2003 but is currently stalled in the Senate.

Yet even as courts and legislatures muddle through the question of offering protection to parents who choose not to medicate their children, controversy deepens over the use of stimulants like methylphenidate - the generic name for Ritalin - by children.

According to testimony given before Congress in 2000, ADHD diagnosis in children grew from 150,000 in 1970 to 6 million in 2000, representing 12 to 13 percent of US schoolchildren.

On the one hand, a recent National Institute of Mental Health study, published in the April edition of the journal Pediatrics, confirmed long-held assumptions that consistent use of stimulants mildly suppresses children's growth - at an average rate of about an inch over the course of two years, in addition to weight loss in some children.

At the same time, another part of the same study gave the use of medication a boost when it comes to the treatment of ADHD. The study showed that strict behavioral regimes, used without drugs, were not as successful as treatments involving stimulants. They suppressed ADHD symptoms in 34 percent of the children tracked over a two-year period, while medication worked in 56 percent of cases.

Yet if the study was reassuring to some who work with children, it was alarming to others.

"The study helps prove that the country is only hearing half the story about ADHD," says William Frankenberger, a professor at the University of Wisconsin, Eau Claire, who has been studying ADHD for almost two decades. "If these medicines suppress growth, you have to ask what else they are doing that we can't measure."

Dr. Frankenberger says pharmaceutical companies pitch ADHD medications in part as a way to help children improve academic performance. While stimulants immediately increase focus (for children with or without ADHD) and often lead to short-term betterment of classroom performance, Frankenberger says his longitudinal research suggests that ADHD medications caused no boost in academic achievement over the long run.

In addition, the length of time a student uses the medication and the type of test given can cloud test results, says Marc Atkins, director of psychology training at the University of Illinois at Chicago. Dr. Atkins, who sometimes works as a paid consultant for Alza, the maker of a popular ADHD medication, calls the NIMH study "cause for some concern" and says it should prompt the medical community to reevaluate the ease with which stimulants are prescribed.

But Atkins - who agrees that schools should not be allowed to mandate medication - takes issue with laws that prevent school healthcare professionals from offering recommendations or a diagnosis to parents.

"To cut schools off from giving parents good information is not what you want," he says.

Frankenberger says one of his research projects examined the origin of initial referrals to psychologists to explore the possible presence of ADHD in children.

"In about 80 percent of the time, we found that it came from teachers," he says.

But overreliance on teacher observations and recommendations to drive use of medication can be problematic, say some experts. It may make judgment calls all the more complicated for parents.

Teachers and school administrators interviewed for this story generally agreed that for some students diagnosed with ADHD, stimulants make a remarkable difference, calming internal storms and bringing normalcy to scattered young lives.

But several also noted worrisome trends in diagnosis, noting, for example, that teachers in crowded, cash-strapped classrooms are more likely to steer a disruptive child toward medication.

Several observed another complicating factor: white middle class or upper middle class boys form the majority of diagnosed cases while minorities - whether due to stigma or lack of access - often go untreated.

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New doubts about medicating kids

Chemical kids

What is a parent to do?

A Cloud Over Antidepressants
by CAROL MARIE CROPPER, Business Week, Apr 26 '04

MANY PARENTS OF teens already know the statistics: Suicide is the third leading cause of death for 15- to 19-year-olds. In any given year, about 20% of all high school students think of committing suicide; almost 10% try.

Now there's a new reason to worry. The only drugs thought to be effective in treating youngsters with major depression are being investigated as a possible cause of suicidal behavior themselves.

Reviews of existing drug company research are under way in the U.S. and England. Hopefully they will shed more light on whether the drugs -- most of which are selective serotonin re-uptake inhibitors, or SSRIs -- cause suicidal behavior. But there is also the more fundamental question of whether these drugs work in children in the first place. Only one antidepressant, Prozac, has proven its effectiveness to the Food & Drug Administration and been approved for pediatric use, although many think Zoloft has also demonstrated efficacy. Other well-known drugs in this category include Paxil, Celexa, and Lexapro. In England, the heath-care regulatory agency has already decided the risks of SSRIs -- except Prozac -- outweigh the benefits for children.

ON THE ALERT

UNTIL THE U.S. RESULTS are in, probably some time this summer, the FDA has advised doctors prescribing these drugs, as well as parents and patients, to be on the lookout for suicidal behavior or worsening depression. Doctors should be particularly vigilant with patients who may have bipolar disorder. Anxiety, agitation, panic attacks, mania, and akathisia (severe restlessness) are some of the symptoms associated with use of antidepressants.

Given the uncertainty, what should parents of a depressed youngster do?

First, children already taking an anti-depressant should not stop suddenly or without first consulting a physician, since withdrawal can hold its own dangers. A 19-year-old Indiana college student hung herself in February after coming off a drug under review. Dr. David Healy, a British psychopharmacologist and leading critic of SSRIs, says patients are most at risk when they start the drugs, increase the dosage, or stop taking them.

Second, depressed children should be evaluated by a specialist in child and adolescent psychiatry, says Dr. David Shaffer, director of Child & Adolescent Psychiatry at Columbia University's College of Physicians & Surgeons. The American Academy of Child & Adolescent Psychiatry (aacap.org) can help you find one. The diagnosing psychiatrist should be able to explain the problem, specify a treatment, explain the reasons for psychotherapy or medication, and describe good and bad effects of any drugs used, he says.

While a nonphysician may be in charge of psychotherapy sessions, a psychiatrist should prescribe and monitor the drugs, says Dr. Shaffer. Antidepressants should not be prescribed by a family doctor or pediatrician unless that doctor has a great deal of experience dealing with childhood depression, says Dr. Robert King, a professor of child psychiatry at Yale University School of Medicine who, in 1991, published the first study suggesting a link between SSRIs and suicidal behavior in children.

For those who want to avoid antidepressants altogether until the evidence is in, two forms of psychotherapy have been shown to be effective in children, according to Dr. Shaffer. The first is cognitive-behavioral therapy. It teaches patients to monitor their moods and to challenge their negative thoughts. For example, a child who thinks no one likes him might be taught to question what evidence he has of that. The patient is also encouraged to participate in social activities as a way to limit negative introspection.

The second form of therapy is dialectical-behavioral therapy, which helps patients understand what causes them stress and avoid getting into those situations. The patient also learns how to cope with unavoidable stress without having a meltdown.

Both treatments are expensive, costing perhaps $100 to $300 a session. Dialectical-behavioral therapy is especially costly since patients meet with a therapist up to four times a week for a year, vs. perhaps one or two sessions a week for four months with other therapies. Just finding someone who practices these disciplines can be difficult for those not living in a major city.

THE PRACTICAL OPTION

THAT LEAVES DRUGS as the most practical treatment option for many. Psychiatrists have strong opinions about whether a link exists between antidepressants and suicidal behavior. Some say much of the behavior described in drug company clinical trials was not really suicidal. Others, like Dr. Healy, argue that studies have pointed to problems with SSRIs since the early 1990s, but drug companies put the evidence aside, dismissing any suicides as an unfortunate but not surprising result of depression.

Dr. Shaffer, who has studied suicide rates among teens, says the rate has dropped as the use of SSRIs has increased. The suicide rate for 15- to 24-year-old males fell from 23 per 100,000 in 1994 to 17 per 100,000 in 2000, he says.

It may turn out that antidepressants reduce suicide risk for the general population of depressed children but increase it for a subset of patients who react adversely, says Dr. King. "I'm absolutely sure that sometimes when you give an SSRI, you get a psychological change for the worse," says Dr. Shaffer. The number of youngsters taking the drug that become more irritable, agitated, and likely to talk about killing themselves may be as high as 10% or 12%, he says.

For those who can't afford therapy or gain access to it, drugs may be a far better solution than not treating a depressed child. But parents need to monitor treatments to make sure the drugs are not producing a dangerous effect.