Eighty percent of thousands of people younger than 19 were misdiagnosed with attention deficit hyperactivity disorder (ADHD) before being tested for fibromyalgia, according to EpicGenetics, a company that developed the first blood test approved (2012) by the U.S. Food and Drug Administration (FDA) for fibromyalgia.
Requiring less than an ounce of blood, the multi-biomarker-based test, the FM/a Test, examines white blood cells’ protein production and identifies fibromyalgia-related immune system abnormalities.
Considering there are about 6.4 million children 4-17 years old with an ADHD diagnosis, there is a high probability that a large percentage of those patients have been misdiagnosed and prescribed ADHD-related drugs, which can be harmful when taken for too long.
To help prevent a misdiagnosis of ADHD in children, EpicGenetics is going to offer the FM/a Test with a 50 percent discount to any child.
“We need to stop treating symptoms, and first determine the correct diagnosis before prescribing drugs,” Bruce Gillis, MD, CEO of EpicGenetics, said in a press release. “By helping to diagnose children’s ailments accurately, we can provide them with a healthier, safer future.”
Fibromyalgia usually is a diagnosis of exclusion. That is because disease symptoms are similar to those of several other disorders. Besides chronic pain, patients often complain of difficulty with concentration and attention, forgetfulness, and problems with word-finding and word fluency.
Mostly diagnosed in childhood, ADHD also is associated with impaired cognition and, like fibromyalgia, thought to be related to dopaminergic function. In fact, evidence indicates a higher frequency of childhood and adult ADHD in fibromyalgia patients, demonstrating a possible association between both disorders.
Overlap of cognitive symptoms in the above-mentioned diseases shows the difficulty in establishing a definitive fibromyalgia diagnosis, especially without a specific diagnostic test to do so — until recently.
According to EpicGenetics, those testing positive for fibromyalgia will be eligible to volunteer for an upcoming clinical trial that has been approved by the FDA.
The trial will include pediatric, adult and elderly volunteers who have their fibromyalgia confirmed by the FM/a Test. More information about the trial and eligibility is available here.
The study will take place at the Massachusetts General Hospital in Boston and be focused on the use of bacillus Calmette-Guerin (BCG), an inexpensive generic vaccine used worldwide to prevent tuberculosis, in the treatment of fibromyalgia.
BCG vaccine appears to activate immune markers, such as anti-inflammatory proteins, that may potentially benefit fibromyalgia patients.
“This trial has the potential to impact the biology of fibromyalgia and now with clinical testing it will be determined over the next four years whether this vaccine has clinical validity as well. Since the generic BCG vaccine is affordable and safe, the clinical trial introduction of this vaccine will perhaps transform the lives of the patients who currently have no other direct treatments available to combat this very debilitating disease,” Gillis said in a previous press release.
“The FDA will be looking at indicators to determine if BCG is having a clinical effect with a decrease in pain for fibromyalgia patients and an increase in overall function in the standardized testing for this disease,” he said. “If the results are promising, we anticipate being able to rapidly expand the BCG treatment to many more patients due to its long-standing safety.”
Despite EpicGenetics’ blood test, most clinicians still use the traditional criteria to diagnose fibromyalgia, including patient interviews to learn about symptoms, pain, and biochemical, plus imaging studies to rule out other diseases.