Sluggish cognitive tempo: Is it a disease independent of ADHD and can drugs treat it?

Is Sluggish Cognitive Tempo a Disease? Or Disease Mongering?

Is Sluggish Cognitive Tempo a Disease? Or Disease Mongering?

Health and medicine explained.
Sept. 29 2014 11:32 PM

The Daydream Disorder

Is sluggish cognitive tempo a disease or disease mongering?

Photo by Digital Vision/Thinkstock
Does this kid suffer from sluggish cognitive tempo, or is he just daydreaming?

Photo by Digital Vision/Thinkstock

The name of a “new attention disorder” sounds like an Onion-style parody: sluggish cognitive tempo. It also sounds like a classic case of disease mongering: blurring normality with sickness to boost drug companies’ bottom lines. But this condition is not satire, and the scientific debate about its existence has already spilled into the pages of the New York Times, after the Journal of Abnormal Child Psychology devoted most of an issue to a special section of 10 papers on SCT. You’d probably call someone with SCT a daydreamer. Indeed, that’s one of the main symptoms, along with lethargy and slow mental processing.

The main cheerleader for SCT as a distinct disorder is Russell Barkley, a psychologist at the Medical University of South Carolina, who since 2009 has received more than $100,000 in speaking and consulting fees from pharmaceutical giant Eli Lilly, which has a drug waiting in the wings that might be used to treat SCT.

These facts suggest a simple narrative of Big Pharma pulling the strings to promote its interests—which is probably what many readers of the Times story concluded.

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But the Times piece took a kicking from PsychCentral, a leading mental health website, which accused the newspaper of “poisoning the well” through innuendo. The site’s CEO noted that it takes a very long time to get official recognition for a psychiatric disorder; 19 years elapsed between the two most recent editions of psychiatry’s Diagnostic and Statistical Manual of Mental Disorders. He concluded that there’s little chance of SCT becoming a disorder any time soon, which makes a grand scheme to concoct a market to suit a new drug seem unlikely.

Both narratives are misleading. To view Barkley as a corporate shill is a gross mischaracterization—in fact, he and others arguing for SCT to be recognized as a distinct disorder are running ahead of Big Pharma, rather than being pushed to further corporate goals.

But a mental disorder doesn’t need the DSM’s stamp of approval to become a focus for the drug industry’s marketing machine, and there’s every reason to be concerned about SCT becoming a future target for disease mongering.

The concern about SCT is inspired in part by the slick marketing of psychoactive drugs for attention deficit hyperactivity disorder, which taps into parents’ worries about their kids’ performance in school. There are parallels between the current discussion over SCT and the diagnostic debate that led to the recognition of Attention Deficit Disorder, and later ADHD, in the 1980s. The latest edition of the DSM estimates that 5 percent of American children meet the criteria for ADHD. Yet according to surveys run by the U.S. Centers for Disease Control and Prevention, the ADHD “epidemic” has swelled way beyond this number: 11 percent of kids ages 4 to 17 had been diagnosed with the disorder in 2011. More than one-half of them—some 3.5 million children—were taking psychoactive drugs to treat the condition. Given that most of the drugs involved are amphetamine-like stimulants with potential for abuse, overuse is a serious concern.

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So we should make sure that society doesn’t sleepwalk into similarly medicating millions of kids for SCT without strong scientific evidence that the benefits outweigh the risks.

Disease mongering is a tough concept to define—but if it looks like a duck, swims like a duck, and quacks like a duck, then it probably is a duck. What we have here seems to be a duck egg. SCT has yet to hatch as a distinct disorder, but if it does, there’s the clear potential for drug companies’ marketing departments to expand its boundaries to encompass people who are not really sick.

The leading definition of disease mongering includes three tactics necessary to get the ball rolling:

  • Taking a normal function and implying that it should be treated.
  • Describing suffering that isn’t necessarily there.
  • Defining as large a proportion of the population as possible as suffering from the “disease.”
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SCT has been studied for three decades as a constellation of symptoms seen in some people with ADHD. What’s changed, bolstering the view that SCT should be seen as a separate condition, is the realization that some people who don’t have ADHD show the same symptoms. But the fact that these symptoms are extreme versions of fairly common behaviors makes it tricky to define.

Two of Barkley’s recent papers, studying SCT in large samples of U.S. children and adults, illustrate the difficulties—and show why we should be wary of blurry and shifting diagnostic boundaries. In the paper on adults, Barkley applied a checklist of nine symptoms to a sample of more than 1,200 people and suggested two possible cut-offs for defining the condition. Barkley’s preferred benchmark is five of the nine symptoms, which would mean that 5.1 percent of Americans have the disorder (about one-half of whom do not meet the diagnostic criteria for ADHD). Lower the bar to four symptoms, and the figure rises to 8.3 percent.

Barkley is also promoting a new name: concentration deficit disorder, arguing that labeling kids as “sluggish” is harmful. Maybe so, but the proposed name change also reinforces the idea that SCT is a disorder, rather than a bunch of symptoms that “normal” people may exhibit to a lesser degree.

Barkley writes materials used for continuing education of mental health professionals. He appears to be laying the groundwork there for the new condition, citing his own work to argue that “research at the moment seems well on the way” to justifying SCT as a distinct psychiatric disorder.

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Still, Barkley is a careful scientist and does not want to define a condition without evidence that it causes suffering. “Is SCT posing enough of a harm to an individual in order to be called a disorder? That is the question,” he told me. “I think we’re seeing that.” Barkley says that people being diagnosed with SCT should not only meet a certain number of symptoms but should also be cognitively impaired. But arguably, he sets a low bar: In the adult study, Barkley judged people impaired if they rated themselves poorly in just 1 out of 15 functional “domains”—including things like home life, social interactions, and money management. And in the child study, he concluded that SCT, while harmful, is not as “severely and pervasively” impairing as ADHD.

Barkley's findings raise a red flag for some mental health experts, who fear that we’re in danger of pathologizing normal mental variation. “You’ve got to be very careful here,” says Jerome Wakefield of New York University, who studies the validity of psychiatric diagnoses. “This is the kind of disorder that parents will see in their kids—whether they have it or not.”

“I think the hand-wringing is vastly premature,” responds Barkley, who also disputes the idea that too many children are being treated for ADHD. “I champion the treatment of those who are impaired, even if they are on the margins of the diagnostic criteria,” he says. “It is unfair on the individual who may come up one symptom short.”

Ultimately, however, concerns about disease mongering center on the behavior of drug companies, not academic researchers. That turns the spotlight on Eli Lilly, which last year published a clinical trial showing that its ADHD drug atomoxetine, marketed as Strattera, reduced SCT symptoms. The trial was designed to see if the drug helps children with both ADHD and dyslexia, and the SCT checklist was just one of several tests used to monitor how they were doing. Lilly included it at the request of an academic psychiatrist on the team, Keith McBurnett of the University of California, San Francisco. Still, when the trial was written up, the company wasn’t shy about trumpeting its finding: “This is the first study to report significant effects of any medication on SCT,” the paper concluded.

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A Lilly spokeswoman told me that it doesn’t comment on plans to seek new uses for its drugs, but both Barkley and McBurnett say that they’re struggling to get the company interested in further trials. So does that mean we can put concerns about disease mongering to rest? Not necessarily, as Barkley notes that Lilly was also initially reluctant to get into the ADHD business. Yet its later embrace of this market was so enthusiastic that it prompted the U.S. Food and Drug Administration to issue warning letters for “false and misleading” promotion of the drug.

If the idea that SCT is a distinct disorder does gain momentum, Lilly may in a couple of years see an opportunity that it can ill afford to ignore. Its patent on atomoxetine expires in 2017, which would open the doors for other firms to make generic versions, denting Lilly’s healthy profits from treating ADHD. But if a new use for the drug is found and approved by the FDA, the company can be granted several more years of exclusive marketing rights for that application.

But wait, don’t psychiatric disorders first have to be recognized in the DSM? Lilly has already shown that this need not be a serious obstacle: In 2000, with its patent on Prozac due to expire the following year, the company won exclusive approval to market the antidepressant under a new name, Sarafem, for a condition called premenstrual dysphoric disorder. Defined as a severe form of premenstrual syndrome, PMDD has been hugely controversial. It became a distinct DSM condition only in the 2013 revision of the manual. By that time, Lilly had made hundreds of millions of dollars from its repurposed drug.

Lilly is not yet pushing to relaunch Strattera as a treatment for SCT, but the stage is being set, should it choose to do so. So let’s take a hard look at the evidence being gathered by Barkley and others, understanding that none of the drugs that might be used to treat SCT are entirely benign. Strattera has been touted as a “safer” ADHD treatment, on the grounds that it isn’t an amphetamine-like stimulant. But about one-quarter of people taking Strattera develop nausea; other common side effects include dry mouth, appetite loss, and insomnia. In rare cases, children taking it have started to feel suicidal, prompting the FDA in 2005 to add a warning to its label—although a recent analysis by Lilly of studies involving almost 3,900 children found no suicides.

If millions of kids really are suffering from a clearly defined disorder, and there’s an acceptably safe drug that can help them lead more fulfilled lives, then by all means, let’s get it approved. But on the evidence presented so far, I’m not convinced. We don’t need millions of kids to be medicated merely because anxious parents have been persuaded that daydreaming is a medical condition.