ELISA

Description of Event or Problem

IN THE 1980S, I WAS BITTEN BY A TICK AND DEVELOPED A LARGE BULL'S EYE RASH (A SYMPTOM THAT WE NOW KNOW IS INDICATIVE OF LYME DISEASE). MY DOCTOR DIDN'T KNOW WHAT IT WAS, AND DID NOT TREAT IN ANY WAY. A WEEK OR SO LATER, I DEVELOPED A SORE THROAT. I WAS GIVEN 5 DAYS OF TETRACYCLINE. SHORTLY AFTER, I HAD SYMPTOMS OF FLU, MUSCLE PAIN, STIFF JOINTS AND EXTREME FATIGUE. I WAS PREGNANT AT THE TIME, AND ATTRIBUTED SYMPTOMS TO PREGNANCY. AFTER I HAD MY SON, I CONTINUED TO BE EXTREMELY SICK. I SAW A PBS PROGRAM (NOVA) ABOUT LYME DISEASE, AND RECOGNIZED THE CLASSIC RASH THAT I HAD SEVERAL YEARS EARLIER. I MADE AN APPOINTMENT WITH AN INFECTIOUS DISEASE SPECIALIST. HE REFUSED TO TEST ME FOR LYME DISEASE. I INSISTED, EVEN OFFERING TO PAY FOR IT. HE RAN THE LYME DISEASE TEST AND TOLD ME IT CAME BACK NEGATIVE. AT THIS POINT, I CALLED DR (B)(6) AT (B)(6). AS I'M SURE YOU ARE AWARE, (B)(6) IS THE PHYSICIAN WHO FIRST RECOGNIZED THE LYME BACTERIUM, AFTER BEING ALERTED BY SEVERAL PEOPLE IN (B)(6). HE TOLD ME THE BULL'S EYE RASH IS DEFINITIVE FOR LYME DISEASE (I.E. I DEFINITELY WAS INFECTED). HE TOLD ME, I SHOULD BE TREATED IMMEDIATELY, WITH 3 WEEKS OF IV CEFTRIAXONE. I WAS AND RECOVERED. THIS IS AN EXAMPLE OF THE FAILURE OF THE EXISTING ELISA AND WESTERN BLOT LYME DISEASE TESTS. IT IS COMMON KNOWLEDGE AMONG SCIENTISTS, CLINICIANS AND PTS THAT THE TEST FAILS ABOUT HALF THE TIME FOR MANY REASONS. FOR EXAMPLE, THE BODY DOESN'T CREATE ANTIBODIES FOR SEVERAL WEEKS OR THE PT HAD EARLY, BUT INSUFFICIENT TREATMENT WITH AN ANTIBIOTIC (MY CASE). IT IS TROUBLING THAT THE FDA CONTINUES TO SUPPORT A TEST THAT IS OFTEN INACCURATE, CAUSING A CURABLE ILLNESS TO BECOME A LIFE-CHANGING, PERSISTENT DISABILITY. THIS IS HIGHLY DAMAGING TO THE FDA'S REPUTATION AND CREDIBILITY AND INDICATES AN ODD LACK OF AWARENESS OF THE SCIENCE THAT HAS BEEN KNOWN FOR 30 YEARS. THIS INACCURATE TEST COSTS THE U.S. BILLIONS IN DISABILITY PAYMENTS AND MEDICAL EXPENSES, AS SERIOUSLY ILL PTS GO FROM DOCTOR TO DOCTOR SEEKING HELP. MISDIAGNOSIS (OR NO DIAGNOSIS) CAN LEAD TO LIFELONG SUFFERING WHEN THE EARLY ILLNESS IS NOT TREATED. THE TEST IS FLAWED. A BETTER TEST WOULD SOLVE THESE PROBLEMS. THE FDA HAS THE AUTHORITY TO APPROVE A BETTER TEST AND WITHDRAW THIS TEST NOW. THE STRATEGY OF DENIAL AND BULLYING PTS HAS NOT SUCCEEDED. IT'S TIME TO MOVE ON.