Description of Event or Problem · 1
I AM CONCERNED THAT THE AO SCAN, PRODUCT OF INNERGY DEVELOPMENT (B)(6) IS BEING USED AS A DIAGNOSTIC TESTING PRODUCT WITHOUT FDA REGULATION. PATIENT PRESENTED TO MY OFFICE ON (B)(6) 2017 WITH REPORT OF AO SCAN. PATIENT WAS CONCERNED THAT THIS TEST SAID SHE HAD A (B)(6) RESULT FOR (B)(6). SHE PROVIDED ME A COPY OF THE 24 PAGE REPORT PROVIDED TO HER FROM THIS SCAN. THIS REPORT CONTAINS AN EXTENSIVE LIST OF MEDICAL DISEASES AND BIOMARKERS AND DESIGNATES A POSITIVE OR NEGATIVE OR NORMAL OR ABNORMAL RESULT FOR EACH. ADDITIONAL TESTS IDENTIFIED AS ABNORMAL FOR MY PATIENT WHICH MADE HER CONCERNED INCLUDED BARTONELLA, (B)(6), LOW GLUTATHIONE, HIGH BLOOD VISCOSITY, CEREBRAL ARTERIOSCLEROSIS, RDW, ADRENAL MEDULLA, PANCREAS, PITUITARY, ACANTHAMOEBA, RACOON ROUNDWORM, AND SCABIES. I EXPRESSED MY CONCERNS ABOUT THE VALIDITY OF THIS TEST TO MY PATIENT AND ORDERED RELIABLE (B)(6) TESTING FOR HER WHICH WAS (B)(6). PAGE 24 OF THE REPORT CONTAINS A DISCLAIMER "IT IS NOT A DIAGNOSTIC TOOL AND CANNOT DIAGNOSE OR TREAT ANY CONDITION OR DISEASE." HOWEVER, IT IS GENERALLY ACCEPTED THAT TELLING A PATIENT THEY HAVE A POSITIVE OR NEGATIVE RESULT FOR A TEST FOR A DISEASE IS EQUIVALENT TO DIAGNOSING A DISEASE, AND THIS SHOULD BE REGULATED BY THE FDA. FURTHER EVIDENCE THAT THE DEVICE IS FUNCTIONING AS A DIAGNOSTIC TEST IS FOUND ON THE (B)(4) WHERE THEY CLAIM GREATER ACCURACY THAN CONVENTION DIAGNOSTIC METHODS OF ULTRASOUND, CT, OR MRI FOR DISEASES LISTED IN A CHART.