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Paragraph 23 reads: ""My position is that the FDA is still dragging its feet, that they're not protecting the citizens and that they're kowtowing to the drug companies," said Robert Scott Fritz, of Long Beach Township, whose daughter, Stephanie, committed suicide in 2003 at age 16 after taking Zoloft for 10 weeks.
CHILDREN TAKING ANTIDEPRESSANTS: What are the risks?
15-year-old boy's murder trial adds fuel to debate over use of 'Zoloft defense.'
By STEFANIE MATTESON
RARITAN TWP. -- On Mother's Day, it was Lisa Van Syckel who Christopher Pittman called. When he went to court, it was Lisa Van Syckel who bought him an oxford-cloth shirt and khakis to wear. And when he was convicted of murdering his grandparents, it was Lisa Van Syckel who cried like the mother he never had.
An activist who has fought the overprescribing of antidepressants to children, Van Syckel, of Raritan Township, has served as a surrogate mother to 15-year-old Pittman for 18 months, talking with him at least once a day. She maintains it wasn't Pittman who killed his grandparents -- it was Zoloft, the antidepressant he had been prescribed.
"I just can't believe it," she said tearfully after his conviction Tuesday. "It's a very sad story. A child was convicted when it is the pharmaceutical company that should have been convicted."
The Charleston, S.C., trial of Pittman, who was sentenced to 30 years in prison, is the first case involving a youngster who said an antidepressant caused him to kill -- the so-called Zoloft defense. Pittman was charged as an adult for shooting his grandfather in the mouth and his grandmother in the head as they lay sleeping.
He had been taking Paxil and then Zoloft for mild depression for about four weeks before the murders, with the dose being doubled from 100 milligrams to 200 milligrams three days before, Van Syckel said.
But prosecutors called the Zoloft defense a smoke screen, saying Pittman, who was 12 at the time, knew what he was doing when he shot his grandparents three years ago, then set fire to their house and drove off in their car, allegedly in anger at their disciplining of him for choking a younger student on a school bus.
While the Pittman trial may have heightened general awareness of the issue, antidepressant safety has long been the subject of vigorous debate among mental-health professionals, patients, parents and advocates. New developments appear to guarantee that the controversy will continue:
The FDA's "black box warning," its most severe, on drugs known as selective seratonin reuptake inhibitor (SSRI) antidepessants goes into effect this month. The warning says that the risk of suicidal thoughts and behavior in children and adolescents during the first few months of treatment is 4 percent -- twice the placebo risk of 2 percent.
The British Medical Journal, in an editorial published Saturday, concluded the "balance between benefits and harms seems to be negative," that there is "little evidence of efficacy" and that physicians should be discouraged from routinely prescribing the drugs to children and adolescents.
A new 17-member state Teen Suicide Advisory Council, which met for the first time last month, has been formed to educate teenagers and their parents about suicide. Another aim is to collect concrete data on how many teenagers in the state attempt suicide and how many complete it.
In an effort to quell mounting parental anxiety, a coalition of 13 mental-health organizations, including the American Psychiatric Association, launched an online resource center, ParentsMedGuide.org, on Feb. 1 to answer questions on the risks of antidepressant use among children and adolescents.
The recent events have stiffened the resolve of parents such as Van Syckel to spread the message of the drugs' dangers. Their efforts have already been partly responsible for the new black box warning, which was ordered in October.
Though the risks described in the warning are small, parents such as Laurie Yorke of Clark, whose son, Ryan, then 16, attempted suicide when coming off the antidepressant Paxil, point out that with 11 million prescriptions for antidepressants being written out for children under 18 in 2002, the risk translates to "a lot of kids."
Despite the fact that the warning hasn't yet started to appear, it is already reducing demand. During the last three months of 2004, the rate of patients under 18 who were prescribed antidepressants dropped 16 percent compared with the same time period in 2003, according to pharmacy benefit managers Medco Health Solutions.
Parents get involved
Van Syckel became involved in 2000 after her daughter, Michelle, then 15, attempted suicide after she had stopped taking Paxil for symptoms diagnosed as depression and anorexia that turned out to be Lyme disease. Michelle, 19, is now a college student who wants to put the episode behind her, her mother said.
Paxil, made by GlaxoSmithKline, is an SSRI antidepressant, a subset that also includes Zoloft, made by Pfizer, and Prozac, made by Eli Lilly & Co.. The drugs act by increasing levels of serotonin, a chemical that is linked with mood, in the brain and body.
And while the FDA has ordered the warning, parents such as Van Syckel say it isn't enough. They have formed an informal network whose goal is to educate the public about the perils of the drugs. "Parents are desperate for answers," she said.
Yorke is a parent who wishes she had known more. She wrote off the changes in her son's behavior -- insomnia, aggression, a decline in his grades -- to being a teenage boy. Despite being a nurse, she didn't realize Ryan's changes could be due to the Paxil he had been prescribed for a panic attack until she started doing research.
Her discovery that Paxil might be causing the symptoms led her -- at the advice of his doctor -- to wean him from the drug. On March 3, 2004, three weeks into the weaning schedule, Ryan, 16, emerged from his bedroom wielding a knife in a "full-blown Paxil rage," she said. "I want everybody dead," he said before slashing his wrists.
"I'm lucky, because he's alive," she said.
Ryan has been off the drug for nearly a year. "He's my kid again," his mother said, referring to the teenager he was before he started taking Paxil. Though he has been receiving home instruction since he started the weaning process, he hopes to return to Arthur L. Johnson High School in September for his senior year.
He has never had another panic attack.
"Paxil has taken a lot away from him," she said. "He'll be stronger in the end, but it's been a hell of a couple of years. No child should have to go through this."
"My position is that the FDA is still dragging its feet, that they're not protecting the citizens and that they're kowtowing to the drug companies," said Robert Scott Fritz, of Long Beach Township, whose daughter, Stephanie, committed suicide in 2003 at age 16 after taking Zoloft for 10 weeks.
Although Stephanie was unhappy, she wasn't suffering from major depression, he said. She swam on the varsity swim team, played junior varsity tennis, was a member of three youth groups and was taking voice and guitar lessons. She was scheduled to sing at The Stone Pony in Asbury Park shortly after her suicide.
"She never should have been on medication," he said. "Unfortunately, we bought the line: you take a pill, and you feel better."
The activists say the drugs are prescribed to teenagers to lift their mood and for reasons unrelated to depression by primary-care physicians who aren't knowledgeable about the risks. The APA confirms that 70 percent of such prescriptions are written by primary-care physicians rather than psychiatrists.
The activists also say that physicians aren't monitoring their patients -- not only for suicidal thoughts and behavior, but also for agitation, irritability and other changes in behavior -- nor are parents being warned to do so. They say such agitation can lead to violence among those who take the drugs, as in Christopher Pittman's case.
Moreover, they say these risks are being incurred for drugs whose effectiveness in treating depression in children has never been demonstrated. They say the studies that do indicate the drugs are effective have been compromised by the researchers' links with the pharmaceutical companies that manufacture them.
Risks of depression
The drug companies and many mental-health professionals, on the other hand, argue that the risk of suicide for teenagers taking SSRIs is smaller than it would be without them and that the drugs save lives by treating depression. Suicide is the third leading cause of death among teenagers, after homicide and accidents.
Matthew Rudorfer of the National Institute of Mental Health, who was among those on an FDA advisory panel who voted against the warning, pointed out that while the risk of being suicidal is increased 2 to 3 percent among children and adolescents taking the drugs, the underlying illness carries a 15 percent risk of suicide if left untreated.
"As part of a comprehensive treatment plan, antidepressants can be extremely helpful for many young people struggling with depression, an illness with significant long-term consequences, including an increased risk for suicide," the APA has said in a formal statement.
The APA has said the warning may have a chilling effect on appropriate prescribing, thus putting seriously ill patients at risk. They have also said the negative publicity may prompt some patients to stop taking the drugs, with an abrupt withdrawal potentially causing serious side effects.
"We believe the biggest threat to a depressed child's well-being is to receive no care at all," APA spokesman Jason Young said.
The APA points to a recent federally-funded study of adolescents with depression, which found in part that patients responded positively to a combination treatment -- an SSRI plus Cognitive-Behavior Therapy, a form of talk therapy, at a rate of 71 percent -- double the 35-percent response rate for patients taking a placebo.
But Vera Sharav, president of the Alliance for Human Research Protection, a watchdog group that tracks the results of clinical trials, points out that six patients who were taking Prozac attempted suicide during the trial, compared to one on the placebo.
The APA also points to data from the Centers for Disease Control and Prevention showing a 25 percent decline in the suicide rate among American youths ages 10 to 19 between 1992 and 2001 -- a 10-year period that corresponds to a marked increase in the prescribing of SSRI antidepressants to that age group.
But Sharav takes issue with those figures, saying that evidence of a correlation is not evidence of causation.
"It's junk science," she said, pointing out that the decline in suicide rates could be linked with any number of factors other than the increase in the use of antidepressants, including the restriction on handguns imposed by the Brady bill, which took effect in 1994.
More children taking antidepressants
Though the issue of children and antidepressants is fraught with controversy, what is not in dispute is the growth in the numbers of children taking such drugs.
Between 1994-96 and 2000-02, the annual number of doctor visits by children between 5 and 17 at which an antidepressant was prescribed nearly tripled -- from 1.1 million to 3.1 million with the rate for adolescents twice as high as for younger children, according to a 2004 National Center for Health Statistics report.
The report, "Health, United States, 2004," which contains a special section on prescription drug use, said that in 2000-02, 8.8 percent of adolescents ages 12 to 17 were prescribed antidepressants. Nearly 70 percent of those prescriptions were for SSRIs, the report said.
The report also pointed out that pediatric use of such drugs is often "off label," which means that because of the limited number of studies on children, physicians prescribe them on the basis of studies in adults. Only Prozac has been approved by the FDA for use in children.
Though Van Syckel settled a lawsuit with Paxil's manufacturer, GlaxoSmithKline, in December, she isn't stopping there. Armed with stacks of pharmaceutical company documents describing the drugs' side effects, she is accusing the companies of putting children's lives in danger by withholding vital information from the public.
"I say I have ODD -- oppositional defiance disorder," she says. "I'm fighting everyone on this issue."
Van Syckel has written the president, the governor and her congressman and senators. She testified at FDA hearings on SSRIs last February and September and attended Congressional hearings in September in which pharmaceutical company executives and FDA officials were grilled about a possible cover-up. She also took up the cause of Pittman, who refers to her as "Mrs. Lisa."
"I wanted to know what the pharmaceutical companies knew, when they knew it and what kind of tactics they're using (to suppress information)," she said. "The fact that they would withhold from the American public the fact that these drugs can cause someone to kill themselves is horrific."
With other parents who testified at the FDA hearings, including Yorke, Syckel has formed the International Coalition for Drug Awareness, an activist group that keeps in touch via the Internet. Members wear silver ribbons with a rose symbolizing the children who have been harmed or died from SSRI use.
Fritz has also become an activist -- for suicide prevention. His daughter is one of eight teenagers in Monmouth County who have committed suicide in the last 16 months -- an average of one every two months -- compared to two in the previous four years. He believes the increase is linked to antidepressant use.
With a close friend whose son also committed suicide while on antidepressants, Fritz has brought the suicide prevention program, Yellow Ribbon International, to New Jersey. The organization aims to educate teenagers and their parents about what to do if they feel they want to harm themselves.
He has also been appointed to the New Jersey Teen Suicide Advisory Council. The aim of the council is to educate families about what to do if a teenager expresses suicidal thinking -- talk therapy being the first step -- and what to look for if a teenager is prescribed antidepressants.
"Some docs aren't telling parents what they need to know," Fritz said, referring to the changes in mood and sleep patterns and especially the violent dreams that preceded his daughter's suicide.
The council is also trying to get firm figures on how many teenagers in the state attempt suicide and how many complete it. The establishing legislation says that fewer than 25 percent of suicide attempts are reported, diminishing the accuracy and amount of the information available.
"Suicide is a taboo subject," Fritz said.
Stefanie Matteson can be reached at (908) 707-3136 or email@example.com.
AT A GLANCE: For more information on adolescents and antidepressants, visit www.drugawareness.org or e-mail Lisa Van Syckel at firstname.lastname@example.org. For Yellow Ribbon International, visit www.yellowribbon.org.
from the Courier News website www.c-n.com