Bioidentical Hormones - U.S. Senate Special Committee on Aging
Bioidentical Hormones - U.S. Senate Special Committee on Aging Bioidentical Hormones - U.S. Senate Special Committee on Aging
It is self-maintaining financially and it's profits are only used to promote the Wiley ill Protocol to doctors and academic institutions and to develop educational materials like the website. Our Process for Standardization In an effort to standardize the compounded preparations of Estrogen and Progesterone we have asked the pharmacists to do several things in order to minimize the potential for variation: * Drug specifications: we use the bulk drugs estradiol and USP progesterone which are recognized and standardized by the United States Pharmacopoeia. We compare the USP Standards with the Certificate of Analysis which accompanies each bulk drug shipment. We want to assure ourselves of that the Purity and Identification Standards are met. * Formulation Specifications: We use a detailed formulation so that the prescription conforms from batch to batch. The formulation is spelled out like a recipe (formulary) and the quantities are recorded with the lot nu1hmbers, expiration dates, if any, and manufacturer's or supplier's name. * Method of preparation is detailed and for our preparations we use specific equipment for weighing, measuring, and mixing. i.e. an ointment mill * In order to assist the patients in measuring the correct dose, we use a special syringe. The objective in using this measuring device is to apply to the skin a specific amount of cream containing a particular content of hormone. The calibrations on the syringe allow for the physician's prescription of the Wiley Protocol to be "individualized" in the spirit of a compounded product to the variation in endocrine physiology from woman to woman. So with the Wiley Protocol we have provided "standardization in customization", something no one has ever done before, except in the case of commercial pharmaceutical products like the Vivelleg and Ctimeras patches which are offered in a range
112 of set doses. The Wiley Protocol's delivery system allows for far more individualized, unique, "finger-printing" of a woman's own original menstrual cycle. * We supply typically a one month supply of medications with a beyond-use date based on literature review, scientific studies, or USP monograph specifications. * We sample our medications and send them out for independent analysis to validate our work. (see attached evidence) * We also test our Compounders for the presence or absence of the "drugs" they are compounding for us in their blood stream to assess potential exposure to the hormones that they are working with. * On the clinical side, we encourage Wiley Protocol prescribing physicians to order blood work for their patients on Days 12 and 21 of the 28 day cycle to assess hormone absorption, compliance and ultimately correlate the findings to the clinical picture so that the patient is best served when adjustments are necessary. * We support PCCA's invented "physician-pharmacist-patient triad" only in the sense that we stipulate the necessity for Collaborative Agreements between Prescribing Physicians and Wiley Registered Pharmacies allowing the Pharmacist to advise WP patients from the WP Clinical Practice Guidelines Manual only when authorized by a WP prescribing physician, assuring that all patients get the same answers and information to any and all unique questions, creating, again, a standardized mode of follow-up that keeps the physician in the loop and on the same page.
- Page 63 and 64: 60 How can we determine whether bio
- Page 65 and 66: 62 doctors-are not getting the obje
- Page 67 and 68: 64 27. Writing Group for the PEPI T
- Page 69 and 70: 66 Dr. MANSON. Well, I think that m
- Page 71 and 72: 68 Statement of Leonard Wartofsky,
- Page 73 and 74: 70 in the WHI. In fact, no study as
- Page 75 and 76: In summary, the Endocrine Society i
- Page 77 and 78: 74 The FDA also regulates aspects o
- Page 79 and 80: Statement of Loyd V. Allen, Jr., Ph
- Page 81 and 82: Statement of Loyd V. Allen, Jr., Ph
- Page 83 and 84: Statement of Loyd V. Allen, Jr., Ph
- Page 85 and 86: 82 Senator SMITH. Dr. Allen, as I h
- Page 87 and 88: 84 Now, when you are talking about
- Page 89 and 90: 86 The only thing the WHI proved wa
- Page 91 and 92: 88 Testimony Of T.S. Wiley before t
- Page 93 and 94: Confusion and Media Hype 90 Instead
- Page 95 and 96: 92 see a doctor tell a diabetic nea
- Page 97 and 98: 94 the only compelling reason to ta
- Page 99 and 100: 96 identical hormones synthesized f
- Page 101 and 102: 98 The world as we know it, from ba
- Page 103 and 104: 100 thereby experienced long period
- Page 105 and 106: 102 Bio-identical progesterone repl
- Page 107 and 108: 104 had reached optimum theoretical
- Page 109 and 110: 106 and the patient can be can reas
- Page 111 and 112: 108 Estradiol and Analytical Resear
- Page 113: 110 A controlled systematic pilot c
- Page 117 and 118: 114 I'd advocate for either Accredi
- Page 119 and 120: 116 D.C., and established a goal to
- Page 121 and 122: 118 If this legislation passes, fed
- Page 123 and 124: first and second finger on the barr
- Page 125 and 126: 122 These products that have been s
- Page 127 and 128: 124 Bcl-2, survivin and variant CD4
- Page 129 and 130: 126 These are experiments by other
- Page 131 and 132: 128 cerebro-cellular inflammation c
- Page 133 and 134: 130 Years # women *1>0.5 8 *1+ 9 *2
- Page 135 and 136: *Breast cancer 132 -57 y.o. recurre
- Page 137 and 138: 134 *Labor intense for patient and
- Page 139 and 140: 136 Senator SMITH. Thank you very m
- Page 141 and 142: 138 makes these hormones uniquely s
- Page 143 and 144: 140 tomize the Wiley Protocol by ra
- Page 145 and 146: 142 "natural," because all lead to
- Page 147 and 148: 144 maceutical commerce, often with
- Page 149 and 150: 146 WHITE PAPER #1 DID YOU KNOW THA
- Page 151 and 152: 148 WHITE PAPER #2 Pharmacy Compoun
- Page 153 and 154: 150 bleeding of the bowel, locate t
- Page 155 and 156: 152 compounding standards can be en
- Page 157 and 158: 154 I. The FDA's definition of a "N
- Page 159 and 160: 156 ORIIGINAL CONTrMIBTION JANMA-EX
- Page 161 and 162: Initially, the design allowed women
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112<br />
of set doses. The Wiley Protocol's delivery system allows for far more<br />
individualized, unique, "finger-printing" of a woman's own original menstrual<br />
cycle.<br />
* We supply typically a <strong>on</strong>e m<strong>on</strong>th supply of medicati<strong>on</strong>s with a bey<strong>on</strong>d-use<br />
date based <strong>on</strong> literature review, scientific studies, or USP m<strong>on</strong>ograph<br />
specificati<strong>on</strong>s.<br />
* We sample our medicati<strong>on</strong>s and send them out for independent analysis to<br />
validate our work. (see attached evidence)<br />
* We also test our Compounders for the presence or absence of the "drugs" they<br />
are compounding for us in their blood stream to assess potential exposure to<br />
the horm<strong>on</strong>es that they are working with.<br />
* On the clinical side, we encourage Wiley Protocol prescribing physicians to<br />
order blood work for their patients <strong>on</strong> Days 12 and 21 of the 28 day cycle to<br />
assess horm<strong>on</strong>e absorpti<strong>on</strong>, compliance and ultimately correlate the findings<br />
to the clinical picture so that the patient is best served when adjustments are<br />
necessary.<br />
* We support PCCA's invented "physician-pharmacist-patient triad" <strong>on</strong>ly in the<br />
sense that we stipulate the necessity for Collaborative Agreements between<br />
Prescribing Physicians and Wiley Registered Pharmacies allowing the<br />
Pharmacist to advise WP patients from the WP Clinical Practice Guidelines<br />
Manual <strong>on</strong>ly when authorized by a WP prescribing physician, assuring that all<br />
patients get the same answers and informati<strong>on</strong> to any and all unique questi<strong>on</strong>s,<br />
creating, again, a standardized mode of follow-up that keeps the physician in<br />
the loop and <strong>on</strong> the same page.