>Of all the cultural markers of the last 10 years the Internet, the
>Simpsons, gourmet coffee shops none has made us feel better than
>Prozac. A wonder drug for depression and a lowrisk prescription,
>Prozac enters its second decade as a household word and not just
>mother's little helper. Grandpa acting grumpy? Benji barking his head
>off? Little Susie feeling sad? Put them on Prozac.
>
>It's no joke. Not only is Prozac widely prescribed to senior citizens,
>and sometimes prescribed for pets, but peppermintflavored Prozac for
>juniors is about to debut. Its manufacturer, Eli Lilly & Co., soon will
>submit to the US Food and Drug Administration the first big study
>showing Prozac's effectiveness in children. Lilly expects to win FDA
>approval this summer and begin marketing the drug for childhood
>depression, which psychiatrists say is an enormous and growing problem.
>
>Nobody argues that children and adolescents get depressed; it's been
>documented for nearly 20 years in the literature of psychiatry.
>Estimates put the number of depressed youth in the United States at
>about 3.5 million, or 5 percent of those under age 19.
>
>If young people are suffering and showing it through antisocial
>behavior, school failures, or suicide threats who can deny treating
>them with the best available combination of psychotherapy and drugs?
>Prozac isn't perfect, but in adults it has produced few side effects, no
>threat of addiction, and great emotional benefit. Early intervention
>with children might even prevent adult depression.
>
>So why hesitate? One reason is that medical science has not proven
>antidepressants work the same way in children and in adults, and even
>the most promising studies don't show they make youngsters well. No one
>knows how Prozaclike drugs, which alter levels of the brain chemical
>serotonin, might affect a growing child.
>
>And there are legitimate concerns that Prozac and its sisters Zoloft,
>Paxil, Effexor and Serzone so easy to get, too quick a fix might be
>overused just as Ritalin has been for hyperactivity. Prozac will make it
>easy to prescribe mellowing antidepressants to children who simply may
>be acting like children.
>
>``This whole trend toward giving pills to children as a solution to
>everything, particularly in the absence of evidence that they work, is
>fundamentally unethical,'' says Leon Eisenberg, a professor of
>psychiatry and social medicine at Harvard Medical School. ``It's driven
>by the convenience of the doctor, the profitability of the drug company,
>and the notion that there is nothing more meaningful to life than
>biochemistry.''
>
>Medical ethics don't stop physicians from treating children with drugs
>that only have been approved for adult use. According to IMS America, a
>research company, an estimated 580,000 prescriptions for Prozaclike
>drugs known as selective serotonin reuptake inhibitors were written
>last year for children 5 and older. Psychiatrists and pediatricians say
>they choose them because they work.
>
>``They work extremely well; children on Prozac tell us they are not as
>angry, and are not as temperamental, behave better, and feel better,''
>says Barbara Ingersoll, a child psychologist in Maryland and coauthor of
>``Lonely, Sad and Angry: A Parent's Guide to Depression in Children and
>Adolescents.''
>
>``It's a tremendous development; we can see a future where mood
>disorders will be treated not as exotic, uncommon conditions in children
>but more like dental caries or poor vision,'' Ingersoll said. ``There
>won't be a stigma for kids on Prozac the stigma will be on not taking
>Prozac.''
>
>Despite the anecdotal evidence and plenty of data on its effectiveness
>for adults, there have been no published clinical studies showing Prozac
>works as a pediatric drug. This is, in part, because drug companies
>historically shun research on children; it is ethically challenging and
>expensive, usually with a small payoff. In this case, a handful of
>studies done on children have found drugs no more effective than
>placebos in treating depression.
>
>Dr. Hugh Johnston, a psychopharmacologist at the University of
>Wisconsin, says it's a mistake to conclude that there is no therapeutic
>effect with antidepressants just because it wasn't found in the
>laboratory. ``If I lose my sunglasses, search the bedroom, and don't
>find them, then do I conclude they don't exist?'' Johnston asks. ``No, I
>keep looking in other rooms because I have indirect evidence they do
>exist.''
>
>The search has intensified because drug manufacturers see a potentially
>lucrative market among 8 to 15yearolds now that growth in the
>saturated adult market 28 million Americans took antidepressants last
>year has slowed. According to Dr. Gary Tollefson, a Lilly vice
>president and psychiatrist who oversees Prozac research, the company
>``feels very good'' about fresh results from the largest controlled
>pediatric study on Prozac; it will be published in July in the Archives
>of General Psychiatry.
>
>In it, 96 children and adolescents, ages 8 to 18 and all diagnosed with
>severe depression, took Prozac or a placebo for eight weeks. At the end
>of the study, which 70 children completed, 56 percent of those on
>Prozac and 33 percent on the placebo said they were much or very much
>better. Those results track more closely to adult studies on Prozac than
>any done before, and it is the first study to demonstrate that children
>feel better on antidepressants than on sugar pills.
>
>``The results are highly suggestive that the medicine is effective for
>severe depression; of course, they need to be confirmed and replicated
>by other studies,'' says Dr. Graham Emslie, a psychiatrist who conducted
>the research at the University of Texas Southwestern Medical School in
>Dallas. ``Despite a lot of unanswered questions about how it'll work in
>the real world, Prozac is probably the right drug for the right kids.''
>
>All those unanswered questions how much Prozac, for how long, in
>children how young, at what longterm risk, and who's making the
>diagnosis in the first place are likely to get swallowed up in
>the medical and family euphoria of having Prozac in the pediatric drug
>arsenal, with the promise of making melancholy teenagers or irascible
>children happier and healthier, and just maybe nipping depression before
>it becomes a painful and debilitating lifelong disorder.
>
>``The real hope is that through early intervention you can significantly
>alter a course that will otherwise lead a child to difficult social and
>parental relationships, poor academic performance, substance abuse, even
>suicide,'' Tollefson said. ``The potential, particularly when you're
>talking about a drug that's safe and effective, is to err on the side of
>using it too liberally.''
>
>Up to now, most pediatricians have been uneasy with psychotropic drugs;
>they largely left it to child psychiatrists to prescribe an earlier
>generation of antidepressants, called tricyclics, which were of
>questionable benefit as well as being toxic, habitforming, and prone to
>produce unpredictable, even lifethreatening, side effects.
>
>Prozac and related drugs that regulate the brain's serotinin levels
>including Luvox, which the FDA approved last month for
>obsessivecompulsive disorders in children present a different story:
>Family practitioners with modest mentalhealth training almost certainly
>will be pushed by parents, aggressive pharmaceutical marketing, and
>managed health care plans, which discourage referrals to costly
>specialists, to diagnose psychiatric disorders and treat them.
>
>``There is increased economic pressure on pediatricians to take a stab
>at it,'' said Johnston, who noted that diagnosing depression in children
>is hard because doctors must rely on either secondhand information from
>parents or their own observations of a child's moodofthemoment. ``A
>child who just got a Beanie Baby at McDonald's isn't going to look as
>depressed as the one who missed a soccer game to come to the
>pediatrician,'' Johnston said.
>
>Dr. David Beyda, a medical ethicist and head of pediatric critical care
>at Phoenix Children's Hospital, says it takes a ``gutsy'' doctor to make
>a diagnosis of depression in children. ``It's a very formidable
>discipline, requiring expertise,'' he said. ``Certainly children who are
>not depressed kids in dysfunctional families, kids whose parents can't
>tolerate their behavior now are going to get diagnosed and treated for
>it.''
>
>So here's an ethical dilemma: Is it wrong to make people who aren't sick
>feel better? Is it more wrong if they are children?
>
>Yes, says Dr. Sidney Wolfe, director of health research for Public
>Citizen, a publicinterest group in Washington, D.C. ``How can you tell
>kids to `just say no' to drugs when everything in the culture, when
>every drug ad, is telling them tranquilizers will make them more normal?
>Talk about a conflicted message!'' Wolfe says.
>
>In his bestselling book, ``Listening to Prozac,'' psychiatrist Peter
>Kramer argues that Prozac's popularity is inversely proportional to
>society's tolerance for everyday emotional pain. Prescribing Prozac
>compassionately for children at risk is a good thing, says Kramer, who
>practices in Providence. But parents who try to make their children's
>lives more perfect through it are narcissistic and misguided, he adds.
>
>Child psychiatrists and psychologists say the debate is healthy but
>ultimately academic. Doctors will try Prozac and its sister
>antidepressants because millions of children need help, some
>desperately. Even at height of the popularity of Valium, Librium, or
>Miltown, we didn't turn into a nation of zombies, and good medical
>practice won't let it happen to children with Prozac, a much safer drug.
>
>``I think we can withstand the pressure from pharmaceutical companies to
>create a Prozac generation, and I hope we won't be pressured from
>the antimedical fringe to deny its use to many undertreated, sick
>children,'' says Dr. Mark Riddle, director of child and adolescent
>psychiatry at Johns Hopkins University. ``We have to go forward, but one
>child at a time.''
>
>(The Boston Globe web site is at http://www.globe.com )
>
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