| The Court's ruling for patient access to
| |
| | This testimony sites those who would have
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| compounded medicines ensures that
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| | been affected -- menopausal women and
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| patients and physicians will continue to
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| | andropausal men; the Autistic community;
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| have access to vital medicines including
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| | men and women with HIV or AIDS; young
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| bio-identical hormones.This was a big
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| | children with gastroesophageal reflux
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| victory for patients who rely on
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| | disease (GERD); hospice and nursing home
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| customized medicines, especially for
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| | patients; people who are very sensitive
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| women taking bio-identical hormone
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| | to dyes and additives in medicines, as
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| therapy. Advocates including small
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| | well as head trauma victims whose lives
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| pharmacies and makers of alternative
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| | can be saved by compounded
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| therapies including T.S. Wiley.
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| | bio-identicals.
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| A ruling by U.S. District Court Judge
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| | It all started when last October of 2006,
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| Robert Junell in August indicate that
| |
| | out of the blue, Wyeth (WYE), filed a
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| patients and physicians have won the
| |
| | complaint with the federal FDA to take
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| battle against Big Pharma, and therefore
| |
| | action against the small pharmacies
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| will continue to have access to vital
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| | making bioidentical hormones from soy and
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| compounded medicines. This victory for
| |
| | other plant materials. Initially there
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| patients who rely on customized
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| | was concern of the dangers of
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| medicines, is especially sweet for women
| |
| | prescription hormones for women thanks to
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| taking bio-identical hormone therapy.
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| | a major study by the National Institutes
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| Small pharmacies and makers of
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| | of Health (NIH) known as the Women's
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| alternative therapies including
| |
| | Health Initiative (WHI). It suggested
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| developers like T.S. Wiley (the Wiley
| |
| | that taking hormones made by Wyeth could
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| Protocol) bio-identical hormone
| |
| | lead to increased risk of heart problems
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| replacement therapy, doctors, patients,
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| | and breast cancer.
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| and other industry organizations
| |
| | Recently a new study was published in the
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| including compounding pharmacists stood
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| | Journal of the American Medical
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| up to this legislation and fought hard to
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| | Association, mentioning that the risks
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| win.
| |
| | were overstated. As synthetic hormones
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| "It is in the best interest of public
| |
| | known as Premarin and PremPro were deemed
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| health," ruled Junell, to uphold the
| |
| | dangerous, the assumption among women
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| legality of compounded drugs. He also
| |
| | using bio-identical regimens is that they
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| said that this legislation passed by
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| | are actually doing something "safer."
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| Congress exempts compounding pharmacies
| |
| | As some experts pointed out, the WHI
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| from such detailed Federal Drug
| |
| | never looked at hormones, but only drugs
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| Administration (FDA) inspections. "It is
| |
| | with "hormone-like" effects that were
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| not feasible, either economically or
| |
| | dosed in a regimen far from that of human
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| time-wise, for the needed medications to
| |
| | replacement.
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| be subjected to the FDA approval
| |
| | The fact that the Court ruled in favor of
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| process."
| |
| | patient access to compounded medicines
|
| This is good news for women on new
| |
| | ensures that patients and physicians will
|
| alternative therapies such as compounded
| |
| | continue to have access to vital
|
| bio-identicals because this battle over
| |
| | compounded medicines. This will also will
|
| hormones for women affects a huge market.
| |
| | allow more research and clinical trials
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| And there are over 40 million women in
| |
| | to take place on bio-identical hormones.
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| the U.S. from the age of 40 to 60. Around
| |
| | This could prove that Wiley's
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| 25 million women annually go into
| |
| | revolutionary discovery is accurate - the
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| menopause. It is estimated that by the
| |
| | fact that it's the rhythm that matters in
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| year 2030, that number will increase to
| |
| | the accurate physiological replacement of
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| 47 million women per year.
| |
| | hormones without side-effects for women
|
| Advocates like Wiley, a medical theorist
| |
| | in the second half of life.
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| in the field of environmental
| |
| | Wiley's findings may have important
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| endocrinology and a writer and researcher
| |
| | implications across a wide range of
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| on the use of hormones, testified on
| |
| | areas, from the treatment of menopause
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| April 19, 2007 before the Special
| |
| | and anti-aging to all of the other
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| Committee on Aging at the United States
| |
| | diseases of aging such as heart disease
|
| Senate. Wiley's in depth testimony is
| |
| | and stroke, Type II diabetes, cancer and
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| available in the Library of Congress.
| |
| | Alzheimer's disease.
|
