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

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COMPOUNDED vs FDA APPROVED

ERIKA SCHWARTZ, MD AGE MANAGEMENT INSTITUTE New York City, NY

A Bit of History

754 AD Baghdad 19th Century compounding led to formulation of phenolic compounds= antibacterial sulfa drugs Compounding used to extract compounds from p g p natural sources like opium = morphine Processes developed:

• Fractionation
• Purification
• Concentration
• Recrystallization

Pharma versus Compounding

“ Economies of scale and not lack of skills

• r knowledge”
• r knowledge

Economics: Principles in Action. (Steven M. Sheffrin – Prentice Hall, 2003, p.157)

FDA

Started late 19th Century Created to help improve public safety‐ adulteration and misbranding of foods October 1937 tragic event killed 106 children‐ Massengill June 25, 1938‐ FDR signed Food, Drug, and Cosmetic Act – requiring medications to be safe Federal Trade Commission jurisdiction over drug advertising‐ not FDA

FDA

1962‐ Amendment to Federal Food, Drug and Cosmetic Act requiring proof of effectiveness New drug applications 6000 in the first 9 years to > 25 000 by 2012 > 25,000 by 2012 1992‐ Compliance Policy Guide‐ distinguishing compounding from manufacturing

(fda.gov)

Compounding in 2013

Majority of IV meds, vitamins, etc. IN HOSPITALS and Clinics Chemotherapy Pain meds Pain meds Pediatric special formulations Veterinary meds Dermatological meds Hormones

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Regulation/Oversight

Compounding – State Pharmaceuticals mass produced‐ FDA‐ Federal

Controversy

Started in the wake of WHI Created 3 groups of prescribers:

• 1. Stopped hormone therapies altogether
• 2. Followed the guidelines ACOG, NAMS, etc.
• 3. Turned to other options for hormone therapies

including compounded ‐17‐beta estradiol ‐ progesterone ‐ testosterone (not available in FDA formulations for women)

HYPE MISINFORMS

Suzanne Somers

Popularizes term BIOIDENITICAL‐ for human identical hormones‐ in the wake of confusion created by WHI and to distinguish between hormone types Presented BIOIDENTICALS as NEW and SUPERIOR options which were unsupported claims

• Available only in COMPOUNDED forms which was not true

(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

“Bioidentical”‐ refers to human identical

17‐beta estradiol, Progesterone, Testosterone, Insulin liothyronine levothyroxine cortisol etc Insulin, liothyronine, levothyroxine, cortisol, etc.

Compounded (circa 1800) or FDA approved drugs (circa 1980) are all synthetic. Pharma= public health economies of scale Compounding =individualized and customized care

FACTS

SALIVA testing does NOT equal COMPOUNDING ESTRIOL can only be obtained by COMPOUNDED prescription

Boothby LA, Doering PL 8/2008‐” Bioidentical therapy: apancea that lacks supportive evidence.”Curr. Opin.Obstet. Gynecology 20. (4):400‐7. MacLennan AH, Sturdee DW 2/2006‐”The bioidentidetical/bioequivalent hormone scam”. Climacteric 9 (1):1‐3.

FACTS

Our role as physicians is to protect our patients and not allow ourselves to be manipulated by either side There will always be the need to create customized medications = COMPOUNDED INDIVIDUALIZED MEDICINE is at the core of INDIVIDUALIZED MEDICINE is at the core of COMPOUNDING

testosterone for women fertility drugs patient preference allergies pediatric dosing requirements, etc

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FACTS

FDA APPROVED

Estrogel .06% ‐ 1 pump QD/mo$115 Vivelle‐dot .0375 – BIW/mo $

COMPOUNDED

TD Estradiol 1.2 mg/Gm‐ 1.2mg/day/mo $30‐40 TD P t 200 /G

$104 Prometrium 200 mg‐QD/mo $182 brand $113 generic

NB: Many insurance plans will change to Premarin instead. TD Progesterone 200 mg/Gm‐ 100 mg QD/mo $30‐40 TD Testosterone 2mg/Gm‐1 mg QD/mo $30‐40

• NB. Insurance accepted by some of

the compounders interviewed