July, 2013

An Open Letter from Dr. Brown Expressing Concern about a Recent FDA Action Related to ADHD

Monday, July 22nd, 2013

An open letter from Dr. Brown expressing concern about recent FDA approval of a diagnostic device for ADHD that is not adequately supported by research and may become a barrier to diagnosis for some.

July 22, 2013

An Open Letter to Margaret A. Hamburg, M.D. 

Commissioner of Food & Drug Administration of the U.S.

Dear Commissioner Hamburg:

On July 15, 2013, your agency issued a press release reporting that the “FDA permits marketing of the first brain wave test to help assess children and teens for ADHD.” In this action your agency, apparently on the basis of a single unpublished study of 275 children, has created significant risks for those affected with ADHD.

Although your press release said “allows marketing” of this device, radio, TV and print coverage of the news over the past week has trumpeted the message as “FDA has approved a brain wave test for ADHD.” For many, this is likely to be interpreted as meaning that the FDA has approved this device to be “safe and effective” for making a diagnosis of ADHD, just as medications approved by the FDA are taken to be safe and effective for treating a specific disorder. 

That press release reported “results showed that the use of NEBA” this newly approved device, “aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD.” This creates the false impression that within 15 or 20 minutes this device has the capacity to provide objective data which can make a more valid diagnosis than a clinician using the usual clinical measures for assessment. This creates a serious risk that a number of clinicians, parents, and others will give undue weight to that brief data sample and, on that basis, deny an ADHD diagnosis to a patient who warrants it or, perhaps, to diagnose someone with ADHD who does not, in fact, have it.  

Current research on ADHD has demonstrated that symptoms of this disorder tend to be situationally variable. DSM-5 states “Typically, symptoms (of ADHD) vary depending on context within a given setting. Signs of the disorder may be minimal or absent when the individual is… in a novel setting…or is interacting in one-to-one situations (e.g. the clinician’s office).”  Just as a brief structural brain image, e.g. SPECT scan, cannot determine a diagnosis of ADHD, so a sample of EEG data cannot provide clinically useful information about how the individual functions in meeting the multiple demands of daily life. Diagnosis of ADHD is essentially based upon careful assessment of the individual’s current history in multiple aspects of cognitive and behavioral functioning in school, work, family life and social relationships. 

As a clinician and researcher confronted daily with the frustrations and suffering of children and adults with ADHD, I urge your agency to reconsider its approval of this device so it does not become a barrier to those who need access to diagnosis and treatment for this complex and often persistent disorder.

Thomas E. Brown, Ph.D.

Associate Director

Yale Clinic for Attention & Related Disorders

Dept. of Psychiatry

Yale University School of Medicine

DSM-5 Changes in ADHD Diagnostic Criteria

Friday, July 5th, 2013

In May, 2013 the American Psychiatric Assn. published a new edition of their Diagnostic & Statistical Manual of Mental Disorders, the reference widely used for diagnosing ADHD and other psychiatric disorders. In this 5th edition there were some useful changes in the diagnostic criteria for ADHD, but there were also some unfortunate omissions.

Useful changes:

  • Age of onset: previously, diagnosis of ADHD required that at least some symptoms of ADHD had been present in the individual by age 7 years. DSM-5 raised the age criterion to having several ADHD symptoms present by age 12 years or earlier.
  • Fewer symptoms required for adults: previously the diagnosis of ADHD required at least 6 of the 9 listed symptoms of inattention and/or 6 of the 9 symptoms of hyperactivity/ impulsivity. Now just  5 symptoms from either set are required for diagnosis of persons 17 years or over.
  • Examples of adult symptoms: previously most of the listed examples of symptoms were childhood behaviors not common in adolescents or adults with ADHD; some examples of common adult ADHD symptoms have been added.
  • Comorbidity with autistic spectrum disorders:  previously the diagnosis of ADHD was not supposed to be made for individuals diagnosed with a disorder on the autistic spectrum.  DSM-5 allows diagnosis of both disorders when criteria for both are met.

Importantly, the DSM-5 does note more explicitly than did its predecessor that “Typically, symptoms vary depending on context within a given setting. Signs of the disorder may  be minimal or absent when the individual is receiving frequent rewards for appropriate behavior, is under close supervision, is in a novel setting, is engaged in especially interesting activities, has consistent external stimulation (e.g. via electronic screens), or is interacting in one-on-one situations (e.g. the clinician’s office).”

Although these changes are useful, this version of the DSM does not very adequately reflect scientific advances in understanding ADHD that have emerged over the 13 years since the last revision or the 19 years since the edition which introduced research-based changes in the diagnostic criteria for ADHD.

  • DSM-5 retains the behaviorally-focused emphasis of previous versions of the manual and does not adequately reflect the underlying cognitive difficulties, the syndrome of executive function impairments, which have been found to be the core of ADHD. 
  • DSM-5 does not adequately address the important role of emotions in ADHD. It does not pick up the impaired motivational aspect of emotions which makes it so difficult for many with ADHD to get started on or sustain effort for tasks not intrinsically interesting to them. And it does not include any symptoms that reflect characteristic problems of persons with ADHD in modulating their experience and expression of emotions.
  • DSM-5 does not recognize the importance of problems in regulating sleep and alertness which have been identified in research on ADHD in children and adults. 

One of the researchers who contributed to the difficult work of revising ADHD diagnostic criteria for DSM-5 once gave an early report on the proposed changes for a group of clinicians and researchers. After being peppered with many queries about “Why haven’t you included this or that in your changes?” the presenter reminded the group, “The DSM follows the field; it does not lead it!”  There is good reason for us to be grateful to those who worked hard to update DSM-5. There is also good reason for us to look to other sources to continue to update and increase our understanding of this complex disorder.