Newsletter June: 2007 In the News

Editors Note First Study on

Bio-Identical Hormones
Welcome to our first issue of the The Doctor’s Newsletter for medical
practitioners. This newsletter is designed to give you the latest research and news The Wiley Protocol® and its
surrounding women in the second half of their lives. And since many of you are multi-phasic physiologic
prescribing the Wiley Protocol® to your patients, we encourage you to read the dosing will be part of a new
newsletter for tips and other clinical practice guidelines. study called Bioidentical
Hormones On Trial, or
We’d love to hear from you so please feel free to write to us with any of your B.H.O.T., at the College of
questions, thoughts or concerns at kgabriel@thewileyprotocol.com. Nursing and Health
Sciences, the University of
Kristin Gabriel, Editor Texas at Tyler.

The study includes a

comparison of patterns of
Hot Flashes and Night Sweats: Treating women on the Protocol who
administration and dosing of
suddenly get hot flashes.
compounded bio-identical
In perimenopausal and some menopausal patients, many of you hear various hormone therapy (BHT).
versions of what are known as hot flashes and or night sweats, caused by This study will be the first of
fluctuating levels of estrogen in perimenopause precipitate vasomotor symptoms. its kind to track and
quantify outcomes based on
As usually, it’s important to find the pattern of the complaint. It’s important to dosing and patterns of
ask your patient if they had hot flashes before they started on the Protocol, and administration of BHT. The
ask them when they typically get the hot flashes in their cycle. Do they happen principal objective of the
all day or night? Last, find out if they are on antidepressants. study will be to examine
clinical outcomes and
Perimenopausal women get fluctuating levels of estrogen precipitating vasomotor quality of life indicators of
symptoms. patients receiving BHT at 10
For patients on the Wiley Protocol the amount of E2 is stable, so it’s a receptor- to 12 primary care
driven event caused by neurotransmitter response which controls the capillary provider's practices. Read
dilation and constriction both internally and in the skin, hence the difference more.
between what is known as a “flush” and flashes.

Sometimes women beginning the WP have hot flashes when they have not had
them before. This is because of the sudden surge of estrogen, which can Pony Express Protein
deregulate receptors.
Protein Found That
For treatment, follow these guidelines: If hot flashes occur: Rallies Biological Clock
Days 1-5 or in Day 13-14 – raise the dose to Wiley E2+2
February 23, 2007 Science
During the luteal phase – lower the progesterone by 2 lines or Wiley P4-2
Daily
Peak Day 12 – lower the E2 by 1 line.
In all cases whenever they occur – spread out the dose of E2 QID A biologist at Washington
University in St. Louis and
his collaborators recently
Testing Schedule: When and Why to Test Patients on the Wiley Protocol identified the factor in
mammalian brain cells that
For women on the Wiley Protocol, blood versus saliva levels are recommended keeps cells in synchrony so
and used to compare to healthy reference ranges of young pre-menopausal that functions like the
women. The assumption is that young women rarely experience heart disease, wake-sleep cycle, hormone
breast or uterine cancers, osteoporosis, vaginal dryness, or Alzheimer’s disease. secretion and loco motor
behaviors are coordinated
 daily. Known as VIP -
Following is a recommended schedule for when to test your patients
vasoactive intestinal
Days 12 and 21 of the 28-day cycle – Test baseline labs E2 and P4 polypeptide - the rallying
protein that signals the
Compounding Issues brain's biological clock.

In the 2007 edition of the Wiley Protocol the progesterone concentration of the This clarifies the roles that
base cream has been changed – due to better bio-availability at 20 mg. per .1 ml both VIP and a
vs. 25 mg. Per .1 ml. neurotransmitter GABA
play in synchronizing
Although we prescribe and apply less, the result in serum levels is higher and biological clocks, and sheds
more reliable. Less hormone powder per tiny line gives a larger area of light on how mammals, in
application for the powder left in the cream, making the ratio of the area of this case mice and rats,
absorption-to-concentrate greater. regulate circadian rhythm.
The results were published
in the Nov. 27- Dec. 1
online issue of the
Proceedings of the National
Wyeth Turns to Menopause Pills after Hormone Debacle Academy of Sciences. Read
more.
May 3, 2007, Bloomberg

Bloomberg’s Lisa Rapaport reported that Madison New Jersey-based Wyeth says
a new approach to treating 40 million American women with menopause may Interest Softens in Safe
generate $5 billion in annual revenue and replace sales lost when its hormone Compounding Drug Act of
therapies were discredited by the U.S.-funded Women’s Health Initiative in 2002 2007
stating that hormone-replacement therapies carried life-threatening side effects.
The drugmaker is trying to revive its women's health-care unit with three After T.S. Wiley testified
experimental medicines for the debilitating symptoms of menopause, such as hot before the Select Committee
flashes and brittle bones. on Aging at the United
States Senate on April 19 in
The first of these new drugs, Pristiq, is set for U.S. regulatory review in July. Washington D.C. it now
Pristiq, a reformulation of Wyeth's Effexor antidepressant, tempers hot flashes appears that we have won
while avoiding side effects tied to hormone use. for now in regards to the
Safe Compounding Drug
U.S. prescriptions for Premarin and Prempro, which contain two female Act of 2007.
hormones, dropped 73 percent to 18.5 million last year from 67.2 million in 2000,
the company said. More than 5,000 lawsuits have been filed against Wyeth, According to news from
alleging its hormones caused cancer. Read the entire article. Washington, interest has
softened. Roberts has
dropped sponsorship and
Kennedy has expressed that
Scientists Unlock Key to Longer Life
he's not interested in
May 10, 2007, BioTech E-Newsletter introducing the bill this year
as he was just testing the
The recent BioTech E-Newsletter from the American Academy of Anti-Aging waters. We'll keep our eye
Medicine (A4M) talks about scientists who have discovered a gene in worms that on it, and in the meantime, if
links eating less with longer life. Researchers at the Salk Institute for Biological you have not read T.S.
Studies in La Jolla, California, have identified a critical gene in nematode worms Wiley’s testimony yet, Read
that specifically links eating fewer calories to living longer. more.

This “longevity pathway” may open the door to the development of drugs that The bill would severely
mimic the effects of calorie restriction and might allow people to reap health restrict access to commonly
benefits without adhering to an austere regime that only the toughest ascetics can compounded medications
endure. that many patients rely on,
especially bio-identical
hormones for women.
Clocking In And Out of Gene Expression Central And Peripheral
Signals Set Circadian
"And what do we think controls this clock…?" T.S. Wiley
Liver Clock February 1,
June 15, 2007 Science Daily 2007, Science Daily-
Public Library of Science
A chemical signal acts as time clock in the expression of genes controlled by a
master gene called a coactivator, said Baylor College of Medicine researchers in Anyone who has
a report that recently appeared in the journal Cell. experienced jet lag will
understand the importance
"We have long known that our bodies live by a daily and monthly and even of a smooth-running
yearly clock and that cells have clocks as well," said Dr. Bert O'Malley, chair of circadian clock. Crossing
molecular and cellular biology at BCM and senior author of this report. "We have time zones decouples our
actually taken this concept to the gene now and said that we are made up of biological rhythms from the
25,000 genes that have clocks too." Genes get expressed and carry out their natural cycle of light and
functions through proteins, he said. Gene expression involves the machinery of dark we're used to. We
the cell translating the gene's code into a protein that carries out function. This perceive light cues through
process has to have a beginning and an end. Read more. retinal photoreceptors that
relay signals to the
suprachiasmatic nucleus
(SCN) in the brain. "Phase
Rice with human proteins to take root in Kansas adjustments" in peripheral
Pharmed food crop approved for growth despite controversy tissues ensure that each
clock follows the same
May 18, 2007, News@nature.com schedule. These can be set
According to an article in news@nature.com rice modified to express proteins indirectly through
often found in breast milk will be planted in Kansas. The go-ahead for the SCN-dependent biological
planting came on 16 May from the United States Department of Agriculture rhythms, such as feeding
(USDA). Many further regulatory hurdles involving other agencies would need to cycles or body temperature.
be passed before products made from this rice could be sold to consumers. How synchronizing cues
operate at the molecular
This is not the first crop designed to produce pharmaceutical proteins given the
level, however, remains
go-ahead in the United States, but it is among the first food crops containing
obscure. Read more.
genes that produce human proteins to gain approval for large-scale planting.
Many other pharmaceutical genetically-modified (GM) crops are grown indoors Biological Clock Of Honey
or in inedible plants such as tobacco. Read more. Bee More Similar To
Humans Than To Insects
Science Daily, Oct 26, 2006

Groundbreaking research
was undertaken by a group
headed by Dr. Guy Bloch of
the Alexander Silberman
Institute of Life Sciences at
the Hebrew University of
Jerusalem. They found that
the molecular structure of
the biological clock of the
honey bee is more similar to
the biological clock of
mammals than to that of
flies. Read more.

Study Cutting Edge

Hormone Replacement
Therapy
Tell your colleagues.
Call Caren at 805.565.7508
www.thewileyprotocol.com