Big Pharma's Misleading Marketing Hurts Children

An article in his week's New York Times reports that AstraZeneca will pay $520 million to settle investigations into its marketing practices for Seroquel. The article states:

AstraZeneca becomes the fourth pharmaceutical giant in the last three years to admit to federal charges of illegal marketing of antipsychotic drugs, a lucrative category of medications that have quickly risen to the top of United States sales charts.

In addition, the article reports

The company has been accused of misleading doctors and patients by playing up favorable research and not adequately disclosing studies that show Seroquel increases the risk of diabetes

The biggest problem with the aggressive marketing of these drugs is not, however, the metabolic side effects. Rather it is the fact that their use stops clinicians from thinking in a meaningful way about how to help their patients. The promise of a quick fix is too hard to turn down, particularly in the face of pressure from the health insurance industry to see many patients in a short period of time.

I recently attended a conference on child psychiatry aimed for an audience of primary care clinicians. Child psychiatrists from major medical centers in the Boston area described current treatment for children who are “irritable” or ”dysregulated." Increasingly children as young as 3 with these symptoms are being prescribed atypical antipsychotics, the class of drugs AstraZeneca has allegedly been illegally marketing.

The head of the course actually recommended that the audience of pediatricians prescribe these medications to their patients, with little more than phone consultation from a child psychiatrist, because of a shortage of specialized services.

I doubt the psychiatrists leading that conference would like to think of themselves as being influenced by marketing in their clinical practice. But I have to wonder. As the article in the Times states "As a result of aggressive marketing, Seroquel has been increasingly used for children and elderly people for indications not approved by the FDA."

At that full day presentation about childhood psychiatric disorders there was extensive discussion about psychoactive medication. But not one mention was made of relationships.

Contemporary research in developmental psychology, which does not have the monetary clout of the drug industry, offers a completely different paradigm from which to understand and help "dysregulated" children. I have addressed these ideas elsewhere on my blog. The essential point of this research is that children develop the capacity to regulate emotions in the context of relationships.

When a child does not have a well developed capacity for emotional regulation, it is likely due to a combination of a child’s genetic vulnerability to dysregulation, and a parent’s capacity to think about and understand the meaning of a child's behavior. The co-regulation of emotion in a caregiving relationship can lead to changes in the biochemistry of the brain, and changes in the way the brain handles stress and strong emotions.

AstraZeneca reported $4.9 billion in Seroquel sales in 2009. That kind of money will never be earned from interventions that support parent-child relationships. But these interventions do not cause weight gain and metabolic disorders, big problems in a population of children already at risk for obesity. And by investing in relationships, we will help the next generation of children grow up to be resourceful, flexible, socially adaptive members of society. Isn't that invaluable?

Study Implicates Genetics and Family Dynamics in ADHD

Trying to understand and then explain the complex interaction between environmental influences and gene expression is a challenging task. An important study published in the April issue of Behavioral and Brain Functions inspired me to give it a try. I start with the actual quote from the study and then attempt to explain it in my own words.

To date, studies have mostly focused on the effects of genetic and environmental influences on ADHD separately. Our work examines the interaction between a specific gene variant and a family environmental risk factor in order to determine their roles in the development of ADHD via behavioral and emotional dysregulation in children.

When ADHD is conceptualized as emanating from the development of emotional and
behavioral regulation, specific genetic and family environmental factors are likely to jointly influence ADHD outcomes in particular ways. The present report capitalized on the potential to investigate an important genetic marker for liability to emotional and behavioral dysregulation (5HTTLPR), along with a particularly salient marker of environmental risk -children’s appraisals of blame in relation to inter-parental conflict.

What this study shows is that a person might have a gene for a serotonin metabolism, known as 5HHTLPR, that puts them at risk for ADHD. But if that person lives in a home filled with conflict, they are more likely to actually have ADHD. Put in a more positive way, just because you have the gene, it doesn't mean you will have the disorder. This study raises the question of whether addressing the environmental risk may protect a person from the genetic risk.

It brought to mind a story of a little boy named Adam who I took care of, a story that haunts me to this day. His mother and father came to see me when he was four years old. He had been in preschool for two months. Already the teachers were encouraging his parents to have him evaluated for ADHD and consider medication.

His parents presented him as a very bright loving child who had a very high energy level. At home, everything was "fine." They had no problems at all with him until he entered school. There he would become overstimulated, particularly when at lunch or other less structured activities. He had a very hard time sitting still and, most problematic for the teachers, he would become impulsive and hit other children. It seemed to both his parents and the teachers that he did not intend to hurt the other children, but that he simply could not control himself.

His father recalled having similar difficulties as a child, but he had outgrown them. Other family members had similar qualities. Both parents seemed to be working well to help him manage his particular challenges. When I met Adam the week after I met with his parents, he was indeed a very bright and engaging little boy. He sat on the floor with me and played a game meant for much older children.

I shared with his parents my impression that likely on a genetic basis he had a tendency for high activity level, and the structured setting of school, which was so new to him, was especially challenging. We discussed some strategies for helping him manage his difficulties, and planned a follow up visit in a month.

A month later they called to say that things were going well and cancelled their appointment. Over the next year Mom called me several times and scheduled appointments, each time cancelling them. She would say that the school wanted him on medication, and she really didn't want to go that route. Then, a month or so into kindergarten, things were not going well. As it had been so long since I had seen them, I asked Mom and Dad to come alone to fill me in.

After about ten minutes of description of Adam's problem behavior, his parents, who were not married, let me know that they were no longer living together. I asked if there had been trouble in the relationship when I saw them the previous year. Reluctantly they acknowledged that "we have never really been together."

Soon I was listening to a barrage of ferocious attacks upon each other. Mom accused Dad of being inept and unavailable. Dad said that Mom simply wanted to drug her son into submission. I sat quietly on my seat as the conflict escalated, feeling increasingly alarmed. Finally I interrupted and asked them if this kind of conflict I was observing was typical, and if so, what that might be like for Adam.

The viciousness was immediately was diverted to me. They were both furious. "What does that have to do with anything? We're not here to talk about us. We just want your advice about how to manage Adam's behavior!"

I spent the rest of the visit trying to turn things around so that they felt I was working with them, not against them. I do not think I was successful. In addition to discussion what to do about Adam's behavior, I suggested that they all go for therapy to address the ongoing family conflict. They left angry and disappointed. I felt terrible. How could I have missed this?

Reading this study makes me wonder, if I could have told them that there was scientific evidence demonstrating that family conflict made a person at risk for ADHD more likely to develop the disorder, would they have been more honest with me? Would them have been more motivated to deal with the problems in their relationship?

I have great admiration for the scientists who are trying to unravel the complex interactions between genes and environment. I hope that parents will draw hope and inspiration from this work. Just because there is a "family history" of a disorder, a genetic risk, does not mean a child's fate is sealed.

Standard of Care for ADHD Violates this Pediatrician's Professional Integrity

After giving the subject much careful thought, I have decided to leave my ADHD practice. In a previous post I described how I inherited a large practice of patients with a diagnosis of ADHD. While I have treated many children who have benefited from stimulant medication, I find the standard of care by which medication is prescribed to be significantly problematic.

Consider this one observation. Many clinicians prescribe medication for ADHD based upon a visit with only one parent. Once, a father called me to set up an appointment to discuss medication for ADHD. I learned that he was divorced and that the child split time between both parents homes. I told the father that I preferred to meet with both parents for the initial evaluation. He said he would call me back to set up a time, but never did. Often I will have one parent say, "His father is totally against medication." Imagine being a child in such a position. Your mother wants you to be on a drug that affects your brain. Your father is against it. Your doctor, without even discussing it with your father, prescribes it anyway. Yet this kind of situation happens all the time.

I also wonder what it does to a child's sense of self to sit in a room once every three to six months and listen to a conversation about his behavior and its relation to a pill he takes every day. Often things are said like, "He's just terrible when he misses his dose." These visits are usually thirty minutes long, and do not offer an opportunity to explore a child's life experience in any meaningful way. Yet this frequency and duration of visit, and line of questioning, is the standard of care for ADHD, and what parents expect.

Behavior management may be recommended in addition to medication. Again, the focus is on making a child behave, rather than exploring the meaning of behavior. Often, there are significant life events contributing to a child's inattention.

Recently I was interviewed by Kaitlin Bell for her upcoming book. She writes thoughtfully about the effects of being medicated since childhood on the current generation of young adults, and explores the complex issues such treatment has raised for them. I hope her writing will help us to think more carefully about the way in which these medications are prescribed.

In addition, while I observe on a regular basis the short term benefits of these medications, I do have nagging doubts about their safety over the long term. It is only with in the last ten to fifteen years that we have huge numbers of children taking stimulant medication for many years, often well into adulthood.

In the February issue of ADHD report Russell Barkley addresses a recent article from Scientific American Mind by Edmund S.Higgins that questions whether long term use of stimulants might take a toll on the brain. Higgins expresses concern that long term effects might include increased risk for anxiety, depression and disrupted cognition, among others. Barkley dismisses the article as "well-crafted propaganda," saying there is no evidence for these adverse effects. In his reply, Dr. Higgings writes,"The history of medicine is replete with examples of treatment interventions that appeared safe but ultimately revealed their adverse effects with long term-controlled studies."

The point is that we don't have good evidence either way. Add to that the fact that there is not good data demonstrating long term benefits, and I feel that I can no longer in good conscience prescribe stimulants year after year to large numbers of children.

I know that someone will prescribe these medications in my absence. In the mean time I will continue to write about my concerns. I am fortunately joined by many others, including Daniel Carlat, in his upcoming book Unhinged:The Trouble with Psychiatry and Robert Whitaker, in his book Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs and the Astonishing Rise of Mental Illness in America who are writing to call attention to the possibly very wrong direction we are headed in the way psychoactive medications are prescribed.

In my clinical practice I will work primarily with young children and their parents. My aim is facilitate healthy development at an age when children's brains are rapidly growing and thus most open to change.

My forthcoming book, to be published by Da Capo Press,
integrates the most contemporary research in child development with stories from my pediatric practice to support parent's efforts to think about their child's mind and the meaning of their behavior, which in turn facilitates the child’s healthy emotional development at the level of structure and chemistry of the brain.

Please stay tuned to my blog for more about both.

A Lesson from Artyom: Adopt with Hearts and Eyes Wide Open

The trauma for Artyom continues. After having been given up to an orphanage by his alcoholic mother who lost her parental rights, being adopted by a US family, sent back to Russia alone when his adoptive mother allegedly was unable to cope with his psychological problems, he has now become the object of a tug-of war between Russia and the US over his citizenship. His future seems to hold unimaginable uncertainty for a vulnerable seven year old boy.

As this battle plays out over the coming weeks to months, I hope we can learn from this tragic tale. As a behavioral pediatrician I often see families who have adopted children out of situations similar to Artyom’s. Among the most hopeful of these is the story of Rachel and Sam.

I vividly remember Rachel’s “aha” moment. She had brought her six year old son Sam to see me because he was aggressive and defiant. Sam was adopted from an orphanage in another country when he was four. Prior to the orphanage he had lived on the streets with his abusive mentally ill mother.

When Sam first came home, he was a terrified child with little language. He immediately began to thrive. But now at six, he was wearing the whole family down. Sam would argue about everything, and frequently these arguments turned into physical battles. Rachel was exhausted and discouraged. She wanted my advice about what to do to control his behavior.

Over 20 years of longitudinal child development research has demonstrated what can happen to children who have been hurt by the very person who was supposed to protect them. This paradoxical situation leads to confused and confusing behavior in relationships with people close to them. When children fear the same person they look to for safety at a time when their brains are rapidly growing, this experience affects the biochemistry of the brain. It creates what is referred to as a state of “hyper-arousal.” This means that a child has great difficulty regulating emotions and may have an overabundance of stress hormones released in response to what seems like a minor event. They do not know how to feel calm and safe.

The adoption agency gave Sam's new family none of this information. Thus his parents were bewildered by the fact that the discipline techniques that had been so effective with their biological children failed completely. I wanted to help Rachel to understand the magnitude of the challenge she and her husband faced, while at the same time not discouraging her.

My thinking was guided by an important research study termed “The Attachment Representations and Adoption Outcome Study.” Miriam Steele and her colleagues found that an adoptive parent’s ability to understand the meaning of a child’s behavior led to a positive relationship between parent and child.

On that magical day of the “aha” moment, Rachel was feeling resigned, deflated. We were focusing on some strategies to manage difficult mornings when she began to talk about her biological children. She suddenly recalled a term from the home schooling philosophy on which they had been raised. The term was “tomato staking” It referred to the way parents stand firm while their developing children twist and turn as they grow up. A parent is always present to guide them in the right direction, and does not ever abandon them.

The image was a vivid one: these plump juicy red tomatoes, healthy because of the strong and steady stake which did little more than stand there. But, Rachel realized, Sam did not have this experience in his early years of development.
Following this visit, Rachel’s approach to Sam changed. She sought out intensive help for Sam. She realized that the whole family needed support in coming to terms with the enormous challenges they faced. Though the work was very hard, the self blame and guilt from which she had been suffering all but disappeared.

I cannot claim to understand what went so terribly wrong for Artyom and his adoptive family. But if we can learn anything from this tragedy, it is that when adopting a child who has been traumatized, it is essential for a family to have both hearts and eyes wide open. And as a country we must offer access to the help they need.

Psychotropic Meds for Preschoolers? Think Again.

The most recent issue of Child and Adolescent Psychopharmacology News is devoted to this controversial subject. The author, Joan Luby, MD, provides a fair and thorough overview of the complexities of the issue. For example, she writes:

Several factors in the current health care system, including structures now in place that provide reimbursement for medication treatment at far higher rates than for psychotherapy, lack of sufficient age-appropriate psychotherapeutic resources in many communities, and impediments and burdens to families that prevent them from obtaining more intensive psychotherapeutic care are all important factors in contributing to inappropriate use of psychotropic agents. Further, over use of pharmacological agents as sedatives should not be used as rationale for thwarting needed research, but should rather be addressed in the pursuit of high quality and appropriate mental health care for children.

But then she goes on to say, in the section of her piece entitled, " Balancing Risk and Urgency to Help: Clinicians on the Front Line,":

In circumstances where no other services are available(lack of transportation, lack of a caregiver with capacity to pursue therapy, no clinicians available with appropriate expertise) and symptoms are severe and impairing, pharmacological agents may be necessary as a first line agent in a young child.

As one of those clinicians "on the front lines" I find this suggestion unacceptable. Certainly there may be cases of severe mental illness in very young children which warrant treatment with psychopharmacological agents. But if such a young child had a brain tumor, parents and clinicians would find the means to get the child appropriate comprehensive treatment by a specialist. Such an illness would not be treated by clinicians "on the front lines." Last year in the Boston Globe I published a column entitled Backed into a Treatment Corner which speaks to just this dilemma.

After just having addressed the problem of use of psychopharmacological agents as sedatives, Dr. Luby has gone on to advocate for just that, essentially saying "if their is no other option, give drugs." As long as we continue to accept this second class citizen status of childhood mental illness, it is unlikely that significant progress will be made towards, in her words, "high quality and appropriate mental health care for children."

The article does address alternatives to psychopharmacology, but states, "the availability of empirically proven psychosocial therapies is insufficient to meet the need." This is where our efforts should be going. Here is one potentially fruitful route of investigation.

Longitudinal studies that follow children from infancy through adulthood have demonstrated a clear connection between a parent’s capacity to reflect on her child’s experience and secure attachment. Secure attachment relationships facilitate the capacity for emotional regulation. Emotional regulation in turn leads to resourceful thinking, social adaptation and overall mental health.

Selma Fraiberg was among the first to describe an intervention that aims to support a parent’s efforts to understand her child’s experience in her classic paper Ghosts in the Nursery. Subsequently, the fields of parent- infant and parent-child psychotherapy have expanded upon these ideas. Minding the Baby at Yale is one example of a reflective parenting program. Short Term Mentalization and Relational Therapy is a form of family therapy that specifically aims to facilitate a parent’s capacity to reflect on her child’s experience.

These interventions are currently used mostly by specialized infant mental health clinicians. I have been able to use this type of intervention in the setting of primary care pediatrics with significant results. In fact, by virtue of the longstanding relationship of trust that many parents have with their pediatrician, the primary care setting is ideally suited to make use of this model of intervention. Perhaps if we put as much energy into investigating these therapeutic techniques, and teaching them to clinicians on the front lines, as we do in discussing and promoting use of psychotropic medication, we would make a safer and more lasting impact on children's mental health.

Teaching Young Pediatricians to Wonder

Last week, I again had the privilege of teaching pediatricians in training. These students were very bright, challenging and asked excellent questions. They all agreed about the limit of the pediatric model of "giving advice." One resident, who had young children of her own, spoke of new mothers using blogs for emotional support. Many of these mothers speak less than kindly about their pediatricians, who they perceive as "not getting it" and telling them "what to do." We agreed that being given advice could be disempowering and that many parenting books, full of advice, actually make parents feel worse.

My seminar's aim was to teach them about the application of contemporary ideas about child development into their practice of pediatrics. This research shows that when parents can think about the meaning of their child's behavior, rather than respond just to the behavior itself, they facilitate their child's healthy emotional development. I shared with them an example from my practice to show how they could support parents in this task.

3 year old Mary had prolonged tantrums at bedtime and was up several times a night. Her parents told me that they would hold the door shut while Mary screamed and threw herself at the door in increasing agitation. Finally after an hour or so of this, one parent would go in to lie down with Mary because she was so agitated, and then she would fall asleep.

My students found the story disturbing, as it was obvious to them that this experience would be frightening for Mary. But I asked them to resist the impulse to give advice about how to manage bedtime and instead asked them to wonder, why were her parents, bright loving people, doing this?

I showed them a slide from a recent lecture by leading researchers in developmental psychology, Peter Fonagy and Mary Target. The slide showed how when people are stressed, their ability to reflect on another person's experience significantly decreased.

Rather than give these parents advice about how to manage this sleep problem, my task was to listen to their story, support them and even perhaps uncover the source of this stress. In doing so I might be able to help them think about what was happening from Mary's perspective.

Because we had a full 50 minute visit, and they began to feel comfortable with me, they did eventually share what was going on. They spoke of a terrible upheaval in Dad's family business and significant financial stress. They realized that Mary was likely responding to the huge amount of tension in the household. she was struggling to engage her increasingly emotionally distant parents. They understood that Mary was experiencing a kind of separation anxiety,and was looking for reassurance. Her anxiety came out most intensely at bedtime, which naturally precedes a long period of separation.

I gave these parents minimal advice about what to do. Instead, I helped them to understand a different way to be with Mary at bedtime. Within a few weeks her sleep problem resolved. My wondering about the meaning of their behavior led them to wonder about the meaning of Mary's behavior.


One of the residents asked me "what do I say?" Residents are taught "what to do" and then tell their patients "what to do." I hope that I conveyed to them that is not about what to say. Its about being present, open and emotionally available. Its about wondering. If they begin to wonder why parents behave the way they do with their children, they will be able to support parent's efforts to wonder about the meaning of a child's behavior.

I realize it's a big leap. One resident in the group was doing a rotation in the neonatal intensive care unit . When treating a critically ill newborn, knowing "what to do" is appropriate. I am asking him to use his brain in a completely different way.

Practicing primary care can be a deeply rewarding experience if we use our relationship with families in the way I have described. But it is not easy. One must be able to switch from a "what to do" mode when dealing with a sick child, to a wondering mode when working with behavior problems, which can make up as much as 40% of primary care visits.

However, if we can do this, we are in an ideal position to promote the healthy emotional development of the next generation. When seen from this perspective, primary care clinicians should be the highest, not the lowest, both paid and valued providers in our health care system.