Rob Waters

Soda and Fast Food Lobbyists Push State Preemption Laws to Prevent Local Regulation

This article first appeared in Forbes Magazine 

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Generation Rx

In the fall of 1996, Nancy Spence, a New Milford receptionist, went into her son's bedroom after work and found a note scrawled on the wall. "Somebody help me, I want to die," it said.

Her son Brian was then 11 and in the fifth grade. He had been taking Ritalin against his will and under pressure from school officials since he was 6, and a combination of stimulants and antidepressants since he was 8. He'd been seen by a psychologist; by a psychiatrist and a family therapist; by a neurologist paid for by his school district; and by another psychiatrist in private practice. No mental health professional had seen him for more than a few visits, and nobody had formed much of a relationship with him.

They had variously diagnosed Brian with Attention-Deficit Hyperactivity Disorder, or ADHD, an unspecified mood disorder and Bipolar Disorder. They had tried putting him on Ritalin, extended-release Ritalin, Dexedrine, Ritalin plus the anti-depressant Wellbutrin and Wellbutrin plus the stimulant Cylert.

All of the drugs and drug combinations had produced side effects -- physical, psychological and social. In second grade, he had been teased at school for his noontime trips to the nurse's office for Ritalin, and he had also developed subtle tics, shaking his hands and jerking his shoulders and other parts of his body. In third grade, he'd started exploding in rage at home in the afternoons as the Ritalin wore off. On Dexedrine, tried as a substitute for Ritalin, he sleepwalked through the day like a zombie, his mother recalls.

At the time that he scrawled the note on his bedroom wall, Brian was still taking Wellbutrin, an antidepressant for adults. Its potential side effects, according to the Physician's Desk Reference, or PDR, include agitation, insomnia and an increased tendency toward seizures. It has never been approved by the Food and Drug Administration as a safe and effective treatment for any childhood psychological condition. He was also still on Cylert, a central nervous system stimulant approved by the FDA as a treatment for childhood ADHD even though the PDR notes that it is associated with some childhood deaths from liver failure and can stimulate tics and Tourette's syndrome.

On this drug regimen, Brian's tics had become much more pronounced. His head and shoulders jerked uncontrollably, and his mouth would make strange blowing sounds. Once, during lunch in the school cafeteria, his arm jumped up and smacked into someone next to him, and he hung his head in embarrassment as the kids around him laughed. He dreaded going to school and nearly every day, when he came home, he hid in his bedroom and cried.

"I felt like nobody liked me," Brian, now 14, remembers as he sits with his mother at their kitchen table in the waning light of a cold autumn afternoon. "Everything was just like -- like downpours."

He had pleaded for years to be allowed to stop taking the drugs, he says, partly because they had disturbed his still-developing sense of who he was. "They made me feel a lot different," he says, groping for words, " -- like, who I am and the way I felt inside."

After discovering her son's scrawled note, Nancy Spence took Brian back to a private psychiatrist he'd seen a couple of times before. She replaced the Wellbutrin with the adult antidepressant Zoloft, a Selective Serotonin Reuptake Inhibitor, or SSRI, that has also never received FDA approval for use with depressed children. Within a week, Nancy recalls, her son became crazed. He ran into the street ignoring traffic, threw lit matches around the house and imagined conversations that never occurred.

It was then, Nancy Spence says, that she finally faced questions that had worried her for years. Were these medications really helping her son? Should she continue to make him take them, or listen to his pleas and challenge the school and medical authorities who seemed so confident of their course?

In the decade since they vaulted into our consciousness, America's love affair with Prozac and other antidepressants has worked its way down the age ladder. Every day, these powerful drugs are prescribed by the thousands to children in a wide range of life circumstances.

According to IMS Health, a research firm that tracks prescription drug sales, nearly 2.98 million prescriptions for antidepressants were written for children and adolescents in 1999 -- more than 11,000 new prescriptions for children every weekday.

This runaway prescribing to children -- often as a substitute for therapy and in the absence of any other intervention -- has become an uncontrolled national experiment. Its subjects are being given unproven treatments more haphazardly, and with fewer practical and legal protections, than adults who volunteer to be paid subjects in the clinical trials of new drugs.

Why is this happening? The immediate causes are easy to name: a cultural romance with biological solutions to social problems; the virtual collapse of family therapy, or any long-term therapy, as an insurance benefit for middle-class families; pressure from managed-care companies that will not fund more than four to six therapy visits without a medication evaluation; harried teachers who pressure school districts to put bored and antsy boys on Ritalin; and the capitulation of overworked and worried parents who may be given a prescription by their child's pediatrician after a seven-minute evaluation.

The ultimate causes, however, lie deeper. In a culture addicted to drugs and quick fixes, but reluctant to confront children's pain, it has become easier and cheaper to medicate kids than to provide them with the time and attention they need from parents, teachers, therapists, mentors and coaches.

By default, this national drug treatment experiment is being carried out in large part by harried pediatricians and family doctors on the front lines -- doctors usually untrained in psychiatry or in treating childhood depression.

Researchers at Kaiser Permanente, the nation's largest health maintenance organization, for instance, recently found that 60 percent of the children ages 12 to 17 who were seen for depression at Kaiser Permanente clinics in Portland, Ore., in 1998 were prescribed antidepressants not by psychiatrists, but by pediatricians. Likewise, a survey presented in May 1999 to the Pediatric Academic Societies' annual meeting found that of nearly 600 pediatricians and family practitioners in North Carolina, 72 percent had prescribed antidepressants to children or adolescents. Nearly one-third had prescribed to children between the ages of 6 and 12. Yet only 8 percent of the doctors thought they were adequately trained in the management of childhood depression. A Clinton administration plan, announced last month, would limit the use of psychoactive drugs on preschoolers but would not affect school-age children.

Some doctors say they are uneasy about prescribing psychoactive drugs to kids, but do so because they doubt that the child's family can get around managed care's barriers to therapy. If he refers a child for therapy, says pediatrician and University of Michigan researcher Jerry Rushton, a health plan may refuse to pay or create months of delays, and parents may fail to follow up. "So sometimes you start them on the meds, and you wait and you hope."

Among poor children, often served by overworked doctors at public health clinics, psychiatric prescribing has been even more haphazard. Looking through the 1996 records of Michigan Medicaid patients, pediatrician Marsha Rappley of Michigan State University and her colleagues found 223 children, all under 3, who had been diagnosed with ADHD. Only one-quarter had received any psychological services. Nearly 60 percent had been medicated with 22 different psychoactive drugs. Medications were often piled on top of one another. In what amounted to medication roulette, one child under 3 had been given, over time, six different medications that affect central nervous system function.

How can children as young as 2 or 3 -- incapable of much self-awareness or cogent speech -- even be effectively diagnosed? With virtually no research on the effects of medicating them, what are clinicians using for guidance -- besides guesswork?

The pressure to medicate comes not only from the urgency physicians feel to do something, anything, for a suffering child. Managed care has transformed the landscape of American medicine. Although psychoactive meds have been given to children since the 1940s, child psychiatrist Joseph Woolston, the medical director of the children's psychiatric unit at Yale-New Haven Hospital, says the practice has skyrocketed over the past five years under managed care.

"The pressure to medicate children has increased enormously," says Woolston. "Every single day, we have at least one case where the managed care reviewer says to us, 'If you don't start the child on medications within 24 hours after admission, we will not fund another day of hospital.' "

Even more alarming, says Woolston, is the increasingly common practice of putting "probably tens of thousands of kids" on almost random combinations of psychoactive medications. "We're using them as guinea pigs, and we're not even keeping track of them. It's scary."

A strong proponent of medicating depressed children is Harold Koplewicz, M.D., director of New York University's Child Study Center. He argues that medication is often the only way to help children with what he considers biologically based, genetically inherited vulnerability to depression and other psychological disorders.

"I say that psychiatric illness is not caused by bad parenting. It is not that your mother got divorced, or that your father didn't wipe you the right way," says Koplewicz. He has written a book called It's Nobody's Fault, with a message many parents find appealing. "It really is DNA roulette: You got blue eyes, blond hair, sometimes a musical ear, but sometimes you get the predisposition for depression."

But what is the scientific basis for the faith that pharmaceuticals for depressed children are far more effective than therapy? So far, the research is unconvincing. At least 13 double-blind, controlled studies of tricyclic antidepressants, and two involving SSRIs, have failed to prove that these powerful drugs provide more than a marginal advantage over placebos when they are given to children.

The most often-cited child study, published in 1997 in the Archives of General Psychiatry, followed 96 severely depressed children who were given Prozac by researcher Graham Emslie of the University of Texas Southwestern Medical Center. After eight weeks, 56 percent of the children on Prozac showed some improvement according to the clinicians who saw them, compared with 33 percent of the kids in the placebo group.

But in their self-evaluations, the kids on Prozac felt they improved only modestly, and not much more than the kids who had taken placebos. And 70 percent of the kids on Prozac still had significant symptoms of depression at the end of the eight weeks.

The FDA has not yet approved the marketing or labeling of any of the SSRIs as safe and effective treatments for childhood depression. But drugs don't have to be proven, labeled or marketed as safe to be legally prescribed to children: Once a drug has cleared the FDA as a safe and effective treatment for one group of patients (in this case, depressed adults), doctors can legally prescribe it to anyone of any age for any reason. Most depressed children who are put on antidepressants receive them under this common practice, known as "off-label" prescribing.

Off-label prescribing to children is extremely troubling in light of cautionary research, published since the early 1990s, suggesting that some children suffer severe, life-threatening side effects on antidepressants and may be too young to alert their caregivers to their problems.

Since 1990, for instance, there have been reports of sudden cardiac arrest and death in seven children taking the older antidepressants desipramine and imipramine, according to a March 1997 report in the Journal of the American Academy of Child and Adolescent Psychiatry. And in the March 1991 issue of the same journal, researchers at the Yale Child Study Center described the cases of six children, ages 10 to 17, who became self-injurious or suicidal while being treated with Prozac for Obsessive-Compulsive Disorder. One 12-year-old boy had nightmares about killing his classmates and daydreamed about killing himself. A 14-year-old girl suffered a near-total breakdown on the drug, scratching her wrists with a knife, slamming a chair on her toes and becoming so violent and agitated she regularly had to be placed in restraints.

Not all side effects reveal themselves with such drama that adults take immediate notice. That makes them especially deadly for children, especially when combined with hurried psychiatric evaluations and poor or nonexistent monitoring. In June 1997, for instance, Matthew Miller, a 13-year-old from Overland Park, Kan., went with his parents to see a psychiatrist assigned through their HMO. According to his father, Mark, an advertising executive, Matthew had been moody and withdrawn for about nine months, since the family moved to a new neighborhood and Matthew started attending a new school. Despite the likelihood that Matthew's depression was situational rather than biological, therapy was not tried.

Instead, the HMO psychiatrist met twice with Matthew and his parents. Matthew had little to say, but his father says that he did tell the doctor that he would never consider suicide. After having Matthew take a computer evaluation, the doctor ruled out Attention-Deficit Disorder. According to Matthew's father, the doctor offered no other diagnosis, but gave the Millers a three-week supply of Zoloft for Matthew, telling them to call back in a week.

Matthew started on the drug the next morning. As the week went by, family members noticed he was becoming more nervous and agitated. On the morning of day seven, he could barely sit still in his seat and argued more than usual with his sister. Sometime that night, after taking his sixth or seventh capsule of Zoloft, 13-year-old Matthew went into his bedroom closet and hanged himself with a belt.

Stories as tragic and dramatic as these are rare. Perhaps more troubling, for the millions of children taking SSRIs, is preliminary evidence that they may affect the architecture of developing brains.

A study published in the January 1999 Journal of Child and Adolescent Psychopharmacology found that Prozac given to young rats caused permanent changes in brain cells. Administering the drug at a time when the brain is still plastic, cautioned authors Viola Wegerer, M.D., and her colleagues, "may trigger adaptive responses which are different from those seen in the mature brain and which may persist for long periods after the discontinuation of the treatment, maybe even for the rest of an individual's lifetime."

The research with young rats could be a warning signal, leading us to conclude that antidepressants should be prescribed to kids with utmost caution, and only when absolutely necessary. But therapists in private practice say managed care reviewers almost automatically suggest referring children out for a medication evaluation after four to six sessions, even when a child's distress seems clearly related to a parental divorce or other interpersonal problem.

"Managed care sees this as a cheap way to get rid of the problem," says Phoebe Cirio, a child psychologist in St. Louis. "They think of antidepressants as equivalent to antibiotics -- let's get in there and kill the germs."

When therapists resist the pressure to medicate, they run the risk of not being able to treat the child at all. In 1997, Mary Lou Sharrar, an Oakland, Calif., therapist, started working with a depressed 5-year-old girl. Her parents had recently separated and had joint physical custody. "She worried about whose house she was going to be at, what her mother's and father's moods would be," says Sharrar. "She felt abandoned by her parents."

After 10 or 12 sessions, Sharrar says, a managed care reviewer refused to authorize further sessions and suggested the girl go on Ritalin. "I said this is a depressed little girl, only 5 years old, and I didn't think Ritalin was the answer," Sharrar recalls. "And they said, 'In that case, let's consider antidepressants.' "

When Sharrar refused to refer the girl for medication, the insurance payments stopped, and the little girl's parents paid for only a few further sessions before withdrawing the girl from therapy.

In another case, Sharrar says, she saw a depressed teenage boy who was trying to come to terms with his gay identity while grappling with his parents' disapproval. Managed care reviewers told Sharrar they would not pay for more than 10 sessions unless the boy started taking antidepressants. Sharrar again refused medication, managed to get 12 sessions paid for the next year and then continued to see the boy without charge when his insurance and his parents refused to pay, providing him with the thing he most needed -- a supportive relationship.

"He had an attachment to me," says Sharrar. "He realized I was there for him."

But neither attachment nor the helpfulness of a long-term, caring relationship with an adult or mentor (well-established as factors in childhood resilience) is concrete enough for managed care. Ian Shaffer, the chief medical officer of ValueOptions in Falls Church, Va., readily concedes that his company requires therapists who treat children, like those who treat adults, to show quantifiable improvement.

"In any treatment where progress is not taking place, we need to ask what is the next step," Shaffer says. "And in disorders where medication has proven to be effective, we might suggest a medication evaluation to determine if they would be helpful."

Jan and Ed Perkins, a northern California couple, belong to an HMO that has prescribed three different medication combinations for their 11-year-old daughter, Amber, since she was 3. The Perkinses are grateful for the relief medications have provided, but they wonder how to help their daughter in the future and whether they've relied too much on the drugs.

By the time Amber was 2 1/2, they recall, she was throwing terrible tantrums and swearing at her parents. "Nothing we would do to comfort her would help," says Ed, a special education teacher, as he sits with Jan, a preschool director, in the living room of their cozy home in the foothills east of Oakland. "She would scream, she would grab things and throw things, she would kick the walls." A psychologist at their HMO, Kaiser Permanente, referred them to a parenting class. Nothing worked for long.

Family or individual therapy was not suggested. Instead, when Amber was 3 1/2, a Kaiser psychiatrist prescribed a combination of Ritalin and clonidine and diagnosed ADHD and other problems. The Perkinses -- minus Amber -- saw the psychiatrist every few weeks to report on how things were going.

"He prescribed the medications, but he wasn't really interested in seeing her on a regular basis. That's kind of the way Kaiser works," says Ed.

The drugs helped, Ed recalls, but not much. So the psychiatrist added a third drug, the tricyclic antidepressant imipramine, when Amber was 4, and she remained on that combination until she was 10. Last year a new psychiatrist prescribed Ritalin, an antiseizure medication and a newer antidepressant.

Amber says she is glad she is on the medications and has a tough time without them. On a warm autumn afternoon, she sprawls on the couch, her head leaning against her mother, her thin legs splayed across her father's lap. On medication, she says, "I can concentrate more. I can get my homework done -- sometimes," she laughs. "I don't know if I could keep from blowing up for one day without the medication."

But she, too, expresses confusion about who, in fact, she is. When things are going well, she says, she's not sure why. "Sometimes I think it's me and sometimes I think it's the medicine. It's pretty hard to tell."

Both Amber and her parents feel that medication for now is the best option. Brian Spence, the New Milford boy who scrawled a suicide message on his wall, felt differently: He had been pleading with his mother, Nancy, to let him get off drugs since he was 6 years old. His mother even agreed once, but when the school threatened to allow Brian to only attend a half day of school unless he took medication, she backed down.

When Brian began throwing lighted matches and imagining conversations, her ambivalence finally broke. "I decided I wanted him off all these medications," she says. "I wanted to know who Brian really was. It had been six years, and I'd had enough."

Brian's journey out of the uncharted world of medication took place with even less medical care and supervision than his six-year excursion into it. When Nancy called Brian's psychiatrist to ask for help, she never even got a call back. So she consulted books and tapered her son off Zoloft and Cylert over the course of three weeks. Within a week of stopping, Brian says, he began to feel his depression lift.

Brian no longer takes antidepressants or stimulants, but does take clonidine to control his tics. Sitting in his kitchen, listening to the rap group Wu-Tang Clan on his headset, he answers my questions haltingly at first. But after a while, the stocky teenager opens up a bit, raising his head from beneath his baseball cap to make occasional eye contact. Pushing the headphones off, he walks over to the kitchen cupboard and pulls three pill bottles off the shelf. "These medications," he says, "they made me uncomfortable to where I just didn't like me."

Today, Brian says, he feels happier and more in control of his life -- though his mother says he still copes with depression around the winter holidays. "I'm popular, I like school better and I like my life better," he says.

Thus, Brian opted out from a continuing role as an unwilling subject in this vast, national experiment. But he is an exception to the larger trend: In the years since Brian's journey began in 1991, more than 1 million more children have been placed on psychiatric medications. Every day, prescriptions are written for other depressed and troubled kids for drugs that affect the central nervous system, promote seizures, stunt growth and blunt sexual response. Children continue to be unwitting subjects in a national experiment whose final cost is still unknown.

The most central principle of medicine is "Do no harm." A cardinal principle of ethical research is that nobody should be exposed to severe risks when the potential benefits of a drug are marginal. Researchers have not come close to proving that these drugs are markedly better than therapy, or even placebo, for troubled children. Why, then, do we continue to treat so many of them as guinea pigs?


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