The Food and Drug Administration (FDA) recently announced its approval of the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, which they claim shows promising results for more accurate diagnosing of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. NEBA, which is based on electroencephalogram (EEG) technology, consists of a short, non-invasive test that looks at the ratio between the brain wave frequencies of beta and theta wave bands. Previous studies have shown differences in these wave frequencies in children and adolescents with ADHD and those without it. In their press announcement, the FDA cited a 2006 clinical study involving 275 children, which showed that when NEBA was used in conjunction with traditional clinical assessments for ADHD, the diagnosis was more accurate than traditional clinical assessment alone.
NEBA, like many new biotechnologies, is met with some criticism. William E. Pelham, the director of the Center for Children and Families at Florida International University, brings attention to the fact that traditional diagnostic methods are relatively accurate, and NEBA, which he regards as supplemental in nature, would unnecessarily increase the cost of ADHD diagnoses. Other researchers have commented that more research needs to be done to confirm how helpful the assessments of these wave bands really are.
The above criticisms are noteworthy, though the ethical issues surrounding ADHD diagnosis were swirling even before NEBA was introduced. In June 2013, the subject of ADHD diagnosis became particularly contested when a study revealed disparities in diagnosis and treatment, which are present between different racial and ethnic groups in the U.S. The Pediatrics study confirmed that even after taking into account numerous confounding factors that may influence behavior, minority children, compared to their white peers, are significantly less likely to be diagnosed with ADHD.
It is unclear whether these results reveal an under-diagnosis of minorities or over-diagnosis of white children; there is some literature to support both sides. Some experts suggest that socioeconomic and cultural differences might be the culprits of such disparities. The study itself noted that the children who didn’t have health insurance, as well as those who were from low income families, were less likely to be diagnosed with ADHD. Children with older mothers who were highly educated were more likely to be diagnosed. However, several of the risk factors for ADHD have a higher occurrence in minority children, which makes it even more unclear why such disparities persist. The Pediatrics study also showed that of those diagnosed with ADHD, minority children were less likely to be using medication to treat it.
Considering the issue of under-diagnosis, there are clear risks and harms throughout various stages of life that can be attributed to untreated ADHD. ADHD is a complex behavioral disorder that effects overall functioning. When unaddressed, it has been linked to issues with substance abuse, failure at school, problems at work, and failed relationships. Once a child has a diagnosis of ADHD, he or she may receive special consideration at school, for instance extra time to take tests, which can provide an academic advantage to those with the diagnosis. Some might argue that using new technologies, like NEBA, while currently cost prohibitive, could one day be a tool to remedy under and over-diagnosis. By having another test that improves the outcome of the diagnostic process, more cases that were not diagnosed previously may now be revealed. This could lead to more children being appropriately treated, lowering their risk for the negative outcomes of under-diagnosed ADHD. Further, with respect to over-diagnosis, NEBA may prove helpful in weeding out cases where ADHD is not the proper diagnosis, and other behavioral issues may then be addressed.
Another argument could be made that technologies like NEBA do not ensure that all children are appropriately screened, diagnosed, and treated, as the Pediatric study suggests needs to happen. If the cost of tests like NEBA are too high, families of low socioeconomic status may have even less access to ADHD screening. Use of NEBA, or technologies like it, may therefore create even more disparity. Furthermore, the results of the June study could indicate other issues, including a breakdown in trust and communication that exists between health care providers and some of their patients (i.e. particularly minority). For example, the study showed that being raised in an English-speaking household made a difference in the likeliness of receiving an ADHD diagnosis.
Addressing language and other communication issues may prove more helpful in ADHD diagnosis than a piece of new technology. As long as the issue of disparities in ADHD diagnosis and NEBA’s implications remain cloudy, the true potential for benefit or harm of using NEBA is unclear. Depending on the details of policies and regulations involving its use, which would be set in the future, NEBA could be key in helping doctors make better diagnostic decisions, or it could exacerbate the disparities that already exist. A call for more research related to health disparities, deeply intertwined with the clinical world, is surely necessary, especially in cases where treatment affecting the daily lives of patients is at stake.
Amaya George is a summer intern at the Montefiore-Einstein Center for Bioethics. She is a rising junior and pre-med student at Cornell University with a declared major of Biology and Society and minor of Inequality Studies.