10/11/2023    

RESPONSES/COMMENTS (NON-CLINICAL) - PART 1 A

RE: Krystexxa and Gout (Allen Jacobs, DPM)

From: John Cozzarelli, DPM

 

Dr. Jacobs' comments on Krystexxa's FDA indication are not accurate. He references that it is indicated for the treatment of hyperuricemia.

 

Direct from the  Patient Package Insert "INDICATIONS AND USAGE KRYSTEXXA® (pegloticase) is indicated, for the treatment of chronic gout in adult patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

 

Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia."

 

John Cozzarelli, DPM, Belleville, NJ 

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09/06/2023    

RESPONSES/COMMENTS (NON-CLINICAL) - PART 1 A

RE: The Increasing Podiatric Abandonment of “Routine Foot Care" (Lawrence Rubin, DPM)

From: Allen Jacobs, DPM 

 

Dr. Rubin notes that podiatrists, in deference to alternative healthcare providers, maintain the ability to provide "optimal preventive and therapeutic foot-care". Optimal care is more than selling diabetic shoes and toenail reduction. It is evaluation and treatment of or referral for treatment of neuropathy, vascular disease, dermatological disorders, gait abnormalities, and off-loading of areas predisposed to ulceration. It is active treatment of onychomycosis. The question you must ask yourself is whether or not you do indeed provide “optimal care" .

 

Allen Jacobs, DPM, St. Louis, MO