Docket Management
Docket: 00N-1256 - Over-the-Counter Products
Comment Number: EC -35

Accepted - Volume 6

Comment Record
Commentor Dr. Murray A. Katz Date/Time 2000-06-27 14:02:32
Organization Southern Arizona Veterans Affairs Health Care Syst
Category Health Professional

Comments for FDA General
Questions
1. General Comments From: Murray A. Katz, M.D. Staff Nephrologist and Chief, Department of Veterans Affairs Professor of Internal Medicine and Physiology Director, B. W. Zweifach Microcirculation Labs. Research Service (0-151) Department of Veterans Affairs Medical Center 3601 South 6th Avenue Tucson, Arizona 85723 To: FDA Comments on agency's approach to regulating over-the-counter drug products. June 27, 2000 Gentlemen: Congratulations on taking this important first step. My comments below are restricted to antihypertensive agents, but are generalizable. I suggest you assemble a small committee of not more than three to five experts in each category to suggest the format for giving the consumer the minimum essential information to make informed consent. In those instances in which a lab test such as a potassium or creatinine after starting a thiazide or angiotensin converting enzyme inhibitor, perhaps the government can use moral suasion to convince the pharmaceutical industry, the managed care organizations, the providers, and the laboratories to underwrite one test. The provider can take further action if indicated. A general statement/warning should be along these lines: Hypertension is high blood pressure. It has nothing to do with mental state or stress. It is a disease without symptoms that gradually destroys nerves, brain, eyes, heart and kidney. The treatment of hypertension PRODUCES SYMPTOMS of dizziness, which usually disappear within four to six weeks of continued therapy. During this time the patient will often develop a SALT HUNGER which must be avoided or the effectiveness of the medicine will be lost. The target blood pressure for adults is about 130/80. Once at target, the pattern of damage to organs produced by hypertension will begin to reverse. I suggest a small preliminary list of medications, doses, and statements: Thiazides -- hydrochlorothiazide -- 12.5 mg each morning. This medication has been proved to prolong life in hypertensive patients. Watch for rash, dizziness. Be careful upon arising or getting out of a car. Within seven to ten days of starting, have a blood test for potassium and creatinine. Beta blockers -- atenolol -- 25 mg each morning. This medication has been proved to prolong life in hypertensive patients. It helps to prevent heart attacks. Watch for dizziness. ACEI -- lisinopril -- 10 mg each morning. This medication has kidney protective effects in diabetes and probably protects the heart after heart attack. Watch for dizziness. It may produce a nagging, dry cough which may require stopping the medication. Within seven to ten days of starting, have a blood test for potassium and creatinine. Calcium channel blockers -- these should be debated, but I believe they are too complex, too variable in heart rate effect, and too expensive to be on the first list. They are well tolerated in part because their effect on blood pressure may be small. Alpha blockers, Alpha-beta blockers, Central alpha stimulators, Vasculoplegic agents are too weak or too strong, or too complicated to be added to the list at this time. Thank you for the opportunity of sharing my comments with you, --mak * * * * * * Brief Profile of Murray A. Katz, M.D. Murray A. Katz, M.D. Staff Nephrologist and Chief, Department of Veterans Affairs Professor of Internal Medicine and Physiology Director, B. W. Zweifach Microcirculation Labs. Research Service (0-151) Department of Veterans Affairs Medical Center 3601 South 6th Avenue Tucson, Arizona 85723 Phone: 520-629-1824 Voice Messaging: 520-629-4763 FAX: 520-629-1801 email: mkatz@theriver.com Brief Resume of Murray A. Katz, M.D. PROFILE: Extensive knowledge and experience as physician, educator and researcher. Board certified internist, nephrologist. Active practice in varied patient settings: government HMO system, contract military patients and dependants, university patients, both inside and outside hospital. Active consulting physician for difficult-to-manage patients with high blood pressure/diabetes/kidney disease, as well as teacher/consultant for colleagues and new providers. Former HMO manager as well as deliverer of care. As educator, teach a broad range of subjects to a varied groups of students: the art and science of medicine, nephrology, physiology, biochemistry, statistics, basic and outcomes research methods, and mathematical modeling. As a researcher, published over 58 first author papers, books, and book chapters in a wide range of subjects ranging from diabetes, kidney disease, physiology, and biomathematics. Lectures frequently on the outcomes of medical practices and the most likely shape of future practice. Research has been invited for presentation regionally, nationally, and internationally. Associate editor and reviewer for many journals. HIGHLIGHTS OF QUALIFICATIONS * Statistics and Higher Mathematics * Medical Research * Statistical & Model Program Development * Clinical Investigation cost free to VA * Hospital Performance Measures * Microcirculatory Research & Practice * President's Council on Improving Calculus Instruction * Nephrology, Internal Medicine * University Instruction SELECTED ACHIEVEMENTS * Teaching health professionals enthusiasm for career. Success has been met by looking ahead to medical practice decades away. Trainees and Nurse Primary Care Providers are taught that a fever and a cough requires only a single five minute evaluation; not two visits, a chest X-ray, and a CBC. Healthy clients are trained to teach other clients healthy behaviors. * Guided the Tucson Veterans Affairs Research Service through largest and most sustained growth and diversification during scarce federal research funding. This program was developed by one-on-one teaching of new researchers in the preparation and methods for success. * Designed the mechanisms whereby all Tucson VA HMO patients can avail themselves of all locally approved research protocols (including cancer trials) at no cost to patients nor the VA. PROFESSIONAL EXPERIENCE Department of Veterans Affairs Medical Center, Tucson, AZ 1974-Present Frontline Managed Care Primary Care and Renal Specialty Provider 1974-Present Associate Chief of Staff for Research 1981-1997 Medical Executive Committee Member and HMO Planner 1992-1997 Founding Director of the Benjamin W. Zweifach Microcirculation Laboratories 1984-Present Assistant to Full Professor of Internal Medicine (Youngest Full Professor) 1974-Present Full Professor of Physiology 1984-Present Teaching of skills to doctors, medical students, nurses, and K-12 students 1966-Present EDUCATION Renal Fellowship Training, University of Texas Southwest Medical School, Dallas, TX Osler Medical House Staff Training, Johns Hopkins University School of Medicine, Baltimore, MD M.D., B.A., Johns Hopkins University School of Medicine, Baltimore, MD (Minor in English with General and Departmental Honors)




EC -35