Lisa A Kavanaugh - Comment

Document ID: FDA-2012-N-0962-0006
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: March 27 2013, at 12:00 AM Eastern Daylight Time
Date Posted: April 15 2013, at 12:00 AM Eastern Standard Time
Comment Start Date: March 11 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: August 2 2013, at 11:59 PM Eastern Standard Time
Tracking Number: 1jx-84g2-4mcu
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Fibromyalgia and Chronic Fatigue syndrome have symptoms which overlap almost completely with Lyme disease and with Mitochondrial Disorders. Personal experience has shown that Lyme testing is inconsistent and incomplete. The treatment for Lyme using antibiotics, the class and dose which promote the lessening of symptoms (to be determined by a Lyme literate physician (Daniel Cameron, MD in MT. Kisco, NY, for one) should be attempted in all cases of suspected Fibromyalgia and Chronic Fatigue, as it could be a tick-borne illness which we are unable to yet identify with our current tests. Both should also be evaluated for mitochondrial malfunction (preferably by C.I.D.E.M. Lab at University Hospital in Cleveland, OH, Dr. Kerr). Once evaluated, if mito defects are found treatment, should support function of the mitochondria in the areas noted to be insufficient. Treating symptoms without knowing the source of the can be dangerous, lead to drug reaction (especially if the mitochondria is malfunctioning) and end up causing the patient to give up hope of ever being well. If a physician is unwilling to try these two antibiotic therapy under close supervision for 6-8 weeks as well as testing/treating mitochondrial disorders, I believe these 2 entities will be renamed for the disorders for which they are rather than named after their symptoms. These symptoms have a REAL cause. Fibro and CFS are the result of disease, either by an invasive organism or damaged mitochondria. Fibro and CFS are symptoms. These people deserve to be treated for the cause of these symptoms. I ask that you compare the list of symptoms for Lyme and other tick-borne illness and Mitochondrial disorders with those with so called Fibromyalgia and/or CFS and see for your selves the incredible similarities. I propose a study be done lead by Daniel Cameron, MD and Allen Segal, DO, two experts in the field.

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