A Bit of History 754 AD Baghdad 19 th Century compounding led to - PDF document

9/30/2013 A Bit of History � 754 AD Baghdad � 19 th Century compounding led to formulation of COMPOUNDED vs FDA phenolic compounds= antibacterial sulfa drugs APPROVED � Compounding used to extract compounds from p g p natural sources like opium = morphine � Processes developed: ERIKA SCHWARTZ, MD • Fractionation AGE MANAGEMENT INSTITUTE • Purification New York City, NY • Concentration • Recrystallization Pharma versus Compounding FDA � Started late 19 th Century � Created to help improve public safety ‐ adulteration and misbranding of foods � October 1937 tragic event killed 106 children ‐ Massengill “ Economies of scale and not lack of skills � June 25, 1938 ‐ FDR signed Food, Drug, and Cosmetic Act – requiring medications to be safe or knowledge or knowledge” Federal Trade Commission jurisdiction over drug advertising ‐ not FDA Economics: Principles in Action. (Steven M. Sheffrin – Prentice Hall, 2003, p.157) FDA Compounding in 2013 � 1962 ‐ Amendment to Federal Food, Drug and � Majority of IV meds, vitamins, etc. IN Cosmetic Act requiring proof of effectiveness HOSPITALS and Clinics � Chemotherapy � New drug applications 6000 in the first 9 years to � Pain meds Pain meds > 25,000 by 2012 > 25 000 by 2012 � Pediatric special formulations � 1992 ‐ Compliance Policy Guide ‐ distinguishing � Veterinary meds compounding from manufacturing � Dermatological meds � Hormones (fda.gov) 1

9/30/2013 Regulation/Oversight Controversy � Started in the wake of WHI � Created 3 groups of prescribers: � Compounding – State 1. Stopped hormone therapies altogether 2. Followed the guidelines ACOG, NAMS, etc. 3. Turned to other options for hormone therapies � Pharmaceuticals mass produced ‐ FDA ‐ Federal including compounded ‐ 17 ‐ beta estradiol ‐ progesterone ‐ testosterone (not available in FDA formulations for women) FACTS HYPE MISINFORMS � “Bioidentical” ‐ refers to human identical Suzanne Somers � 17 ‐ beta estradiol, � Popularizes term BIOIDENITICAL ‐ for human identical � Progesterone, hormones ‐ in the wake of confusion created by WHI and to � Testosterone, distinguish between hormone types � Insulin liothyronine levothyroxine cortisol etc � Insulin, liothyronine, levothyroxine, cortisol, etc. � Compounded (circa 1800) or FDA approved drugs � Presented BIOIDENTICALS as NEW and SUPERIOR options which were unsupported claims (circa 1980) are all synthetic . � Pharma= public health economies of scale � Available only in COMPOUNDED forms which was not true � Compounding =individualized and customized care (Sherr L, Ruppel G ‐ 2/16/2007 ‐ “ Suzanne Somers; Super Saleswoman: Has Somers Found the Fountain of Youth?”. ABC news Kantrowitz B; Wingert P ‐ 11/13/2006 ‐ ” A Real Somers Storm: At war over Suzanne Somer’s book on “bioidenticals””. Newsweek FACTS FACTS � SALIVA testing does NOT equal COMPOUNDING � Our role as physicians is to protect our patients and not allow ourselves to be manipulated by either side � ESTRIOL can only be obtained by COMPOUNDED � There will always be the need to create customized prescription medications = COMPOUNDED � INDIVIDUALIZED MEDICINE is at the core of � INDIVIDUALIZED MEDICINE is at the core of COMPOUNDING � testosterone for women � fertility drugs Boothby LA, Doering PL 8/2008 ‐ ” Bioidentical therapy: apancea that lacks supportive evidence.” Curr. Opin.Obstet. Gynecology 20. (4):400 ‐ 7. � patient preference MacLennan AH, Sturdee DW 2/2006 ‐ ”The bioidentidetical/bioequivalent hormone scam”. Climacteric 9 (1):1 ‐ 3. � allergies � pediatric dosing requirements, etc 2

9/30/2013 FACTS FDA APPROVED COMPOUNDED TD Estradiol 1.2 mg/Gm ‐ Estrogel .06% ‐ 1 pump 1.2mg/day/mo QD/mo $115 $30 ‐ 40 Vivelle ‐ dot .0375 – BIW/mo TD Progesterone 200 mg/Gm ‐ TD P t 200 /G $104 $ 100 mg QD/mo $30 ‐ 40 Prometrium 200 mg ‐ QD/mo TD Testosterone 2mg/Gm ‐ 1 mg $182 brand QD/mo $113 generic $30 ‐ 40 NB: Many insurance plans will NB. Insurance accepted by some of change to Premarin instead. the compounders interviewed 3