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.