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
117 severity of their head injury. "We think it's just shifting the whole curve," making all but the most severely injured patients better off, Wright says. "It way outdid what we were expecting." This Could Be Your Son, Brother, Father or Grandson Marcus Baskett of Commerce, Ga., was one of those patients. A passenger in a head-on automobile collision just three weeks shy of his high school graduation, Baskett was evacuated by helicopter to Emory and received the progesterone infusion upon his arrival. In addition to broken bones, early tests of his brain function suggested massive and disabling head injury, and he spent almost three weeks in a coma. But seven weeks after his April 2004 injury, Baskett was released from the hospital with lingering physical injuries but little evidence of the severe trauma to his brain. Three years later, a 21-year-old Baskett keeps up a rapid-fire conversation and lives close to his parents' home but independently, keeping track of appointments and birthdays on a cell phone scheduler. "I wouldn't have believed that a woman's compounded hormone would help my body and brain in a situation like that," Baskett says. 'Im back almost 100%, and I don't think I'd be here if it weren't for progesterone." Senators Kennedy (D-MA) Burr (R-NC) and Roberts (R-KS), among others are as I write this, considering legislation (Safe Compounding Drug Act of 2007) that would severely restrict and possibly deny access to critical medications. This draft bill is supported not only by Wyeth in an attempt to retrieve their lost revenue stream from Compounders dispensing Bio-identical hormones which out perform Wyeth's PremPro, but by Astra Zeneca, through their funding of Mothers of Asthmatics. Astra Zeneca, by working through this ostensibly public and non-commercial Mothers of Asthmatics has falsely portrayed the Safe Compounding Act as a patient-driven. There has been no harm to asthmatics, only to Astra Zeneca's bottom line, because Astra Zeneca believes that Compounders have "knocked-off' one of their inhalant products.
118 If this legislation passes, federal regulators, not the doctor, will decide what medicines can be taken. I believe that it is fundamentally the right of the consumer to choose and the practitioner to practice. Among other things, the so-called Safe Drug Compounding Act would give the Food and Drug Administration the power to: * Broadly eliminate the availability of many critical, commonly compounded medications that many patients rely on (most especially bio-identical hormones for women). * Determine when compounded medicines are needed - a decision that has always been and should always be made by doctors. * Restrict the compounded medications the doctor can prescribe even if he or she determines the needfor them. Among those left with little or no choice will be menopausal women and andropausal men; the Autistic community, individuals living with HIV/AIDS; infants and young children with conditions like gastroesophageal reflux disease (GERD); hospice and nursing home patients; and people who are extremely allergic or sensitive to fillers, dyes, and additives in medicines. And now we can add researchers with imagination like Dr. Wright in Georgia and head trauma victims like the young man, whose life and mind was saved by a Compounded bio-identical hormone. Please don't let this happen.
- 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 and 114: 110 A controlled systematic pilot c
- Page 115 and 116: 112 of set doses. The Wiley Protoco
- Page 117 and 118: 114 I'd advocate for either Accredi
- Page 119: 116 D.C., and established a goal to
- 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
- Page 163 and 164: ards analyses," stratified by clini
- Page 165 and 166: year). These 'drop-in" rates were a
- Page 167 and 168: years of prior use, 11 vs 2; HR, 4.
- Page 169 and 170: trogen plus progestin exposure. Clo
117<br />
severity of their head injury. "We think it's just shifting the whole curve," making all but<br />
the most severely injured patients better off, Wright says. "It way outdid what we were<br />
expecting."<br />
This Could Be Your S<strong>on</strong>, Brother, Father or Grands<strong>on</strong><br />
Marcus Baskett of Commerce, Ga., was <strong>on</strong>e of those patients. A passenger in a<br />
head-<strong>on</strong> automobile collisi<strong>on</strong> just three weeks shy of his high school graduati<strong>on</strong>, Baskett<br />
was evacuated by helicopter to Emory and received the progester<strong>on</strong>e infusi<strong>on</strong> up<strong>on</strong> his<br />
arrival. In additi<strong>on</strong> to broken b<strong>on</strong>es, early tests of his brain functi<strong>on</strong> suggested massive<br />
and disabling head injury, and he spent almost three weeks in a coma.<br />
But seven weeks after his April 2004 injury, Baskett was released from the<br />
hospital with lingering physical injuries but little evidence of the severe trauma to his<br />
brain. Three years later, a 21-year-old Baskett keeps up a rapid-fire c<strong>on</strong>versati<strong>on</strong> and<br />
lives close to his parents' home but independently, keeping track of appointments and<br />
birthdays <strong>on</strong> a cell ph<strong>on</strong>e scheduler.<br />
"I wouldn't have believed that a woman's compounded horm<strong>on</strong>e would help my<br />
body and brain in a situati<strong>on</strong> like that," Baskett says. 'Im back almost 100%, and I d<strong>on</strong>'t<br />
think I'd be here if it weren't for progester<strong>on</strong>e."<br />
Senators Kennedy (D-MA) Burr (R-NC) and Roberts (R-KS), am<strong>on</strong>g others are as<br />
I write this, c<strong>on</strong>sidering legislati<strong>on</strong> (Safe Compounding Drug Act of 2007) that would<br />
severely restrict and possibly deny access to critical medicati<strong>on</strong>s. This draft bill is<br />
supported not <strong>on</strong>ly by Wyeth in an attempt to retrieve their lost revenue stream from<br />
Compounders dispensing Bio-identical horm<strong>on</strong>es which out perform Wyeth's PremPro,<br />
but by Astra Zeneca, through their funding of Mothers of Asthmatics. Astra Zeneca, by<br />
working through this ostensibly public and n<strong>on</strong>-commercial Mothers of Asthmatics has<br />
falsely portrayed the Safe Compounding Act as a patient-driven. There has been no harm<br />
to asthmatics, <strong>on</strong>ly to Astra Zeneca's bottom line, because Astra Zeneca believes that<br />
Compounders have "knocked-off' <strong>on</strong>e of their inhalant products.
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