Risk Management

Back in December 2005 — three months ago — Sweet M started taking Focalin, a stimulant medication for the attentional deficits that figure in her neurological makeup. We started her on the medication over the Christmas school break so we could monitor the effects of the stimulant closely. We had tried one of the ADHD medications before, and it had increased her anxiety — and therefore her episodes of dysregulation, aka meltdowns — so we had previously discontinued use of a stimulant medication. In other words, we were proceeding with caution.

Her attention and focus improved immediately, and we enjoyed a remarkably easy Christmas holiday. When she returned to school, the positive reports came in almost immediately. Her speech language therapist reported that she'd had her best day ever — and had actually been chatting, that is, making conversation rather than using speech for purely pragmatic purposes.
Her teachers commented that she was starting to follow along in group discussions during class. And the formal assessment of the effectiveness of the medication — something called a SNAP-IV survey — showed remarkable gains in her behavior.

These two charts show the changes in her various symptoms when treated with Paxil alone, versus when treated with a combination of Paxil and Focalin. Although there is a slight increase of obsessive symptoms when the stimulant medication is added, the drop in inattentiveness and impulsivity is pronounced.

It's odd to think of a bar graph as a sort of picture of one's child, but in so many ways, it can be — each bar is a snapshot of her behavior (or, more accurately, my assessment of her behavior) at particular junctures.












And just in case my answers are skewed — impacted by my knowledge of her medications — there is also the classroom teacher's evaluation, which shows a similar effect, though with fewer "snapshots."











About six weeks after we started seeing these genuinely positive results from the Focalin, the FDA issued a black box warning —its most serious warming — on all ADHD stimulant medications, Focalin among them.

I heard the news on the radio and at first it seemed serious: 25 children who were taking one of these medications, had died suddenly with strokes or heart failure. Sweet M's godmother, who was visiting at the time, shared her concerns. I wondered and worried:

What did it really mean? What were parents supposed to do? What were we going to do?

It took a while to sort out the implications of this most recent panic, but the reality is that the FDA's decision to black box these medications was not based on any new evidence or new studies. Rather it was based on the fact that a total of 25 people, among the millions who are now prescribed stimulant medications, suffered from cardiovascular failure. It is not unusual for 25 individuals in a million to have such failures, even without medications.

Dr. Edward Hallowell, who specializes in the treatment of ADHD, writes in the Los Angeles Times:

The [FDA] recommendation was based on an upsurge in stimulant prescriptions, which the panel found alarming when coupled with 25 reports of sudden deaths in people taking the medications — even though there was no proof the stimulants caused the deaths. In other words, it isn't that the drugs are more dangerous than we thought, it's that they're probably being too freely prescribed: A federal survey found that nearly 1 in 10 12-year-old American boys takes a stimulant.

Stimulants have been used since 1937 to treat what we now call attention deficit disorder or attention deficit hyperactivity disorder. Used properly, they have been proved safe and effective. Like all medications, and even water, stimulants used improperly can be dangerous, even fatal. But keep perspective: Aspirin is more dangerous for adults than stimulants. And penicillin is estimated to kill 500 to 1,000 people each year. Yet we rightly revere aspirin and penicillin, while cautioning that they be used with care. No black box needed.

So what about those 25 sudden deaths? First, it is not at all clear that because a person dies when taking a certain medication, the drug caused the death. Nor is there evidence that the number of sudden deaths is statistically significant — meaning more than random. There are 30 unexpected, sudden deaths per year per 1 million children between the ages of 10 and 14. More than 1 million children of that age take stimulants. Of the 25 deaths cited by the FDA panel, 19 were children. Therefore, we cannot conclude that stimulants raise the risk of sudden death.

So why the panic? Panic and risk management are an increasingly prevalent state of mind and response to contemporary events. Cultural critics Toby Miller and Marie Claire Leger have written a valuable article that makes the point that contemporary parents are engaged in a complex calculus of risk management. In a rapidly changing global order where there is the risk of occupational obsolescence not only for ourselves, but also for our children, parents are engaged in ongoing assessments of what is riskier for their children: taking a stimulant medication and remaining competitive in school, and subsequently, it is hoped, in a global economic context, or exposing their children to potential side effects from various psychotropic medications, Ritalin among them.

Miller and Leger are building on the work of German social theorists Urlich Beck and Elisabeth Beck-Gernsheim, who argue that we are moving into a new period of modernity that has as its main features a highly atomized form of individuality that they call individualization. In this context, class affiliation and social status become less important. And instead of engaging in a battle for access to resources, we find we are engaged in all sorts of activities intended to minimize our risks. They call this "the risk society." In a sense, we all become unconscious insurance actuaries, trying to assess what course of action will offer our selves and our children the greatest chances to survive, and we might even hope — on a good day — thrive.

Rather than condemn individuals for their use of psychopharmacological interventions, Miller and Leger analyze these trends within a particular moment of late modernity, in which individuals are urged to work on themselves, and their children, to remain ever marketable — as human capital.

As a parent who is actively engaged in such assessments — and who among us isn't? — keeping Sweet M on the Focalin was a no-brainer. Beyond the fact that Sweet M is regularly monitored for changes in her blood pressure (a possible side effect of the stimulant medication), the reality is that the FDA's decision to black box these medications was not based on any new evidence or new studies.

While I might long for a world where my daughter could thrive without either of the medications she takes, we certainly do not inhabit such a world now, nor can I expect that we will we anytime soon. My own tendency to want to resist or refute the medical protocols of our day are mitigated by my parental desire to create the best possible life for my child in a world where the odds are already stacked against her.

And so while it's a bit odd to think of parenting as a risk assessment exercise, I'm afraid that the Becks, Miller, and Leger are probably correct: we're constantly calculating the odds and aiming for the best outcomes.

May we continue with the finest information, our very best possible judgment, and the most beneficial outcomes for all.

Keywords: autism • Asperger's Syndrome • ADHD • parenting • Ulrich Beck • Elisabeth Beck-Gernsheim • Toby Miller • Marie Claire Leger • risk society • Ritalin