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COM
October 12, 2008

The Wiley Protocol

Clinical Practice Newsletter
Our mission in this newsletter is to inform health care professionals about biomimetic
hormone replacement therapy and to promote healthy aging and optimal patient

In This Issue
In The Trenches: • In The Trenches- 1
• What the Future
Doctor to Doctor Holds-2
Three doctors who are pre-eminent • Important Items-2
practioners of the Wiley Protocol discuss the finer points of clinical • Greening of the Wiley
practice guidelines based on their experiences with the day-to-day use Protocol-2
of the Wiley Protocol. They have been involved with the Protocol for • Evidence for Us-3
several years. The doctors: Courtney Paige Ridley, M.D. an OB-GYN • Testimonials-3
from Dallas TX; Yun-Ching Chen, M.D. an internist from Santa Cruz • Welcome Letter- 4
CA; and Julie Taguchi, M.D, an oncologist from Santa Barbara CA. • Funding Progress-4
Dr. Chen: Any problems with women who have to use a small amount • Wiley Protocol Rhythms
of cream vaginally chronically (1/2-1 line BID at most) or otherwise Lineup- 5
have terrible absorption? • Calendar of events -5
Dr. Taguchi: No.
Dr. Ridley: No, but remember to treat the patient and not the labs. Dr. Zava may be right in that a
lot of this hormone may be in the capillary bed and not showing up in the serum. Hopefully we will
get this worked out in the next few months as I start testing people

Dr. Chen: I am noticing multiple women with a significant drop, rather than an increase, in their
DHEA after being on WP. What is the mechanism? Is this an indicator that these women should be
on T also? Even if their sex drive is already much improved on just WP?

Dr. Taguchi: Is the T also low? I suspect that the more E and P, the more testosterone is needed and
therefore the more DHEA. I do see low DHEAs and absolute zero levels of testosterone after some
time- but that would be expected if exogenous E is given.Dr. Ridley: Remember, DHEA can
convert to cortisol, T2 and E2. Testosterone can also get lost in a whole host of downstream 17
ketosteroid metabolites. If you have someone with significant adrenal cortical insufficiency, when
you replace reproductive steroids, particularly estrogen, you can put backward pressure on steroid
chemistry. This may result in increased DHEA, but it could also manifest in higher levels of 17 KS
or cortisol. Check their SXs. Are they getting oily and acne? Is this aggravated during P4?
Cont. on Page 6

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What the Future Holds
UTT STUDY: University of
Texas at Tyler Is Conducting
Research on Bio-Identical
Hormone Therapy
The Wiley Protocol® and its
multi-phasic physiologic dosing will be part of
a new study called Bio-identical Hormones On
Trial, or B.H.O.T., a comparison of patterns of
administration and dosing of compounded
bio-identical hormone therapy (BHT). This
study will be the first of its kind to track and
quantify outcomes based on dosing and
patterns of administration of BHT. The
principal objective of the study will be to
examine clinical outcomes and quality of life
indicators of patients receiving BHT at 10 to
12 primary care providers’ practices.
Currently an accepted standard for
compounded bio-identical hormone
replacement protocol or therapy does not
exist. The results of the study will be used to
help establish which dosage and pattern of
BHT administration is most effective. Results
will be used to design a prospective,
randomized clinical trial with the goal of
standardizing BHT dosing and administration
patterns. The principal Investigator for the
study is Assistant Professor Janith Williams,
DNP, WHNP, RNC, and the co principal
investigator is Julie Taguchi, MD, physician
and research coordinator at Sansum Clinic
Santa Barbara, California.
The study is an observational, prospective
study of women ages 35 to 60 who are
current users of compounded bio-identical
hormone therapy (BHT). Clinical care of study
participants will not be changed as a result of
study participation. The duration of the study
is three years. Outcomes to be monitored
include quality of life, symptom relief, and
impact of BHT on physical health including
breast, endometrial, and cardiovascular
measures.
-T.S. Wiley
THE GREENING OF THE WILEY PROTOCOL
We’re working on ways of recycling the syringes used in the Protocol, and you can help.
Please let us know what the laws and regulations about recycling these syringes are in your
area. We’ll pass it along in this newsletter to let you know how you can make a difference.
Just contact caren@thewileyprotocol.com.
October 12, 2008
Important Items
Stopping Cancer Cells Before They Start?
Inhibitor of Gene Regulator Discovered
ScienceDaily (Sep. 25, 2008) — North Carolina State
University chemist has discovered a molecule that can
potentially stop the production of cancer cells at the very
beginning of the process by switching off the gene
regulators responsible for turning healthy cells into cancer
cells. The discovery could lead to the development of
drugs that can treat some of the deadliest forms of cancer,
including brain cancer. More
Hormone Therapy before Radiation Seed
Implants for Prostate Cancer
ScienceDaily (Sep. 23, 2008) — Men over 70 years of age
with early-stage prostate cancer have 20 percent higher
mortality if they are treated first with hormone therapy
before being treated with radiation seed implants
(brachytherapy), compared to men who are treated with
brachytherapy alone, according to the largest cohort study
of its kind presented September 23, 2008, at the American
Society for Therapeutic Radiology and Oncology's 50th
Annual Meeting in Boston. New research shows that
androgen deprivation hormone therapy can have negative
effects on survival, in addition to many other previously
known side affects from this treatment. More
Epilepsy, Autism, Schizophrenia: Master Switch
That 'Balances the Brain' Found
ScienceDaily (Sep. 25, 2008) — Neuroscientists at
Children's Hospital Boston have identified the first known
"master switch" in brain cells to orchestrate the formation
and maintenance of inhibitory synapses, essential for
proper brain function. The factor, called Npas4, regulates
more than 200 genes that act in various ways to calm
down over-excited cells, restoring a balance that is
thought to go askew in some neurologic disorders. More
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October 12, 2008

Evidence For Us
HT users with breast cancer had smaller tumors

North American Menopause Society19th Annual Scientific

Meeting. New data reveal that women diagnosed with breast
cancer while using hormone therapy had smaller tumors and an
earlier stage of breast cancer, compared with their non-using
! peers. The researchers also reported a higher five-year survival
rate for women with breast cancer using HT. Jing-Hong Kim, MD,
and Mee-Ran Kim, MD, obstetrician/gynecologists at The Catholic
University of Korea, conducted a study to determine associations between HT use and
prognostic indicators of breast cancer among postmenopausal women who had and had not
been treated with HT. Using medical records between 1995 and 2004, the researchers
collected data on various characteristics, such as age at diagnosis and menopause, method
of treatment, size of tumor and mortality rate. Women using HT had a higher operative
menopause rate of 41.38% compared with 16.84% among non-users (P=.0014). HT users
also had a higher well differentiation rate compared with non-users — 53.85% vs. 13.36%
(P=.0026). More than half (55.17%) of women treated with HT had tumors in stage T1 or
lower compared with 28.57% of women who did not take hormones. Women using HT also
had smaller tumors than nonusers (P=.0032). These findings were presented at the North
American Menopause Society 19th Annual Scientific Meeting in Orlando.

–Katie Kalvaitis

It is interesting that researchers in Korea are finding the same thing we have found in
our American studies. A number of observational studies have shown that women on
hormones have a less invasive, more easily curable cancer. It’s thought that the
reason is that the hormones are acting as a promoter rather than a cause, and
cancers in these women may be picked to operate early because of increased
surveillance. The interesting thing is that these data run contrary to what was seen in
the Women’s Health Initiative, in which researchers reported more invasive, larger
cancers that weren’t estrogen-receptor positive in the treated estrogen plus progestin
arm. There is a dichotomy there that is not well-explained.

– Michelle P. Warren, MD, Endocrine Today Editorial Board member

Testimonial
I feel most fortunate to have attended the Wiley Protocol Certification Program. Listening to T.S.
Wiley passionately speak about the universe, the earth, the moon and how it is all intimately
connected to each woman, and man, has renewed my faith in science, medicine and my role as a
physician to help spread her "Revolution" to heal, balance and restore women's health more
naturally. She has brilliantly reminded us of our "greater connection" to nature. Being a Woman's
Health Specialist, it is with a heightened sense of clarity and understanding that I feel more
confident to help my patients overcome the difficult transition of menopause more naturally. Thank
You T. S. Wiley for thinking outside the box. Gowri R. Rocco, MD

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October 12, 2008

WELCOME IAN MCGUINNESS

Hello,

I am happy to share with you that joining Wiley Systems to support

you is a new Director of Pharmacy Relations, Ian McGuinness.

Ian has worked in the healthcare industry for over six years, in both a
health outcomes consulting role, and in the role of client
management and business development. In his new role at Wiley
Systems, Ian will provide you with client service support, addressing
your questions and issues, and will act as a liaison for our pharmacist
in charge, Dana Nelson. Ian will increase and coordinate Wiley’s marketing efforts on your
behalf.

As we grow our partnership with you, Wiley Systems continues to focus on expanding the range
of services that we can offer to our pharmacy partners, as well as improving the quality of
support we provide. You are the key to the Wiley Protocol’s success.

Over the next few weeks, as Ian gets up to speed, you will hear from him to introduce himself,
and to begin to work with you. You can reach him today at ian@thewileyprotocol.com. Ian will
also be at the Las Vegas ACAM conference on October 15-19 (www.acamvegas.com) with our
exhibitor team, in our booth 513. He would love to meet you.

Should you have any questions and/or concerns, please feel free to contact me directly.

Regards,

Caren Abdela

PROGRESS
The University of Texas at Tyler has received it's first significant piece of funding from a Friend
of the Wiley Protocol for the 3 arm study to be overseen by Janith Williams and Dr. Julie
Taguchi to commence in 2009.
The research study is accepting donations which can be sent to: Office of Women's
Health Research Bio-identical Hormone Research Project, c/o Dr. Janith Williams,
College of Nursing and Health Sciences, The University of Texas at Tyler, Tyler, Texas
75799. One hundred percent of the funds received will be applied to this project.
Donations of any size are welcome and donors will receive a receipt for tax purposes
and a letter recognizing contributions.

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October 12, 2008

OUR LATEST RELEASES

1. Wiley Protocol for Men™ utilizing
DHEA and Testosterone
2. Wiley Protocol Thyroid™ for
Women
3. Wiley Protocol Testosterone ™
for Women
4. Wiley Protocol Face Crème™
!
The Two Days Back on Earth Seminar™ experience has taught us that most doctors
prescribe vitamin supplements, herbs, and statically dosed hormones (testosterone,
thyroid, etc) ) that interactively interrupt the youthful rhythms recreated by the Wiley
Protocol®, causing unnecessary side effects by de-railing receptor anticipation. To
address this issue, in the spring of 2008 Wiley Systems released the Wiley Protocol®
branded rhythms, five (5) new original, bio-mimetic creams that replicate ancillary
hormone rhythms. A male hormone therapy program to help optimize men’s health
was included. The hormone creams are pictured above.

CALENDAR OF EVENTS

Schedule time for the T.S. Wiley Certification Seminar -- Two Days Back on Earth. Doctors
spend 2 days becoming familiar with Environmental Endocrinology and biomimetic hormone
restoration therapy of estrogen, progesterone, testosterone, DHEA, HGH, melatonin, and
thyroid, with iodine and Vitamin D addressed. This seminar provides 17 CME credit hours in the
category of 1PRA for only two days of attendance. It benefits your practice and the women and
men we serve, and will also ultimately help our study to keep biomimetics available in the United
States. The seminar cost is $1,850.00 including materials such as the updated Physician's
Clinical Guidelines Manual (17 CME credits) more information...

If doctors attend one of the conferences where we exhibit, coupons for a 10 to 15% discount on
the cost of the seminar are available. Conferences include:
• A4M Dec 12-14, 2008 in Las Vegas.
• We will be exhibiting at the Sands Expo and Convention Center (Booth 2035)

The Physician’s Clinical Practice Guidelines Manual provided at the seminar is available for $650.00
and can be purchased separately. Updates will be automatically sent to current manual owners
at no additional cost.

If you'd like to participate, contact Caren at caren@thewileyprotocol.com or 805.565.7508.

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October 12, 2008
In the Trenches- continued
Are they agitated or cranky or water retentive? Chances are, they are just adrenal insufficient and
when you take away the need for the adrenal to make estrogen, the DHEA output goes down and
gets absorbed in an attempt to restore a more normal cortisol level.

Dr. Taguchi: So are you replacing a lot of women with Cortef?

Dr. Chen: I am confused about [Dr. Ridley’s] comment that DHEA can be converted to cortisol.
As far as I'm aware of, DHEA converts to androstenedione, which can then interconvert back/
forth to T. Are you suggesting that maybe 17-OH-pregnenolone gets backed up if one is
supplemented with excess DHEA, which can eventually be converted to cortisol? This does
NOT explain my question of why I am seeing women on WP get significantly decreased DHEA.
Perhaps the DHEA is still being consumed up to make T in these women, which is my question
about whether we should be more diligent about replacing T also. The only other mechanism I
can reason is that perhaps excess P is being used as a precursor to make cortisol and aldosterone,
and in the process, less DHEA is made. By this reason, there should be plenty of cortisol, rather
than a deficiency as you are suggesting.

Dr. Ridley: Perhaps I was not clear. DHEA/Cortisol levels/ratio is considered an indicator of
adrenal reserve. When DHEA levels fall, it suggests poor adrenal reserve. 90% of my patients are
significantly deficient in cortisol output. Americans are 60% less adrenally active than our
European counterparts and the labs that we use in the US are using "healthy Americans" as their
database. You do the math. The body will always defer to survival before it will to reproduction.
We slap on a bunch of reproductive hormones, where do you think it is going to go? Cortisol
receptors can bind everything. Just look what happens to many of these people when they use P4
- it diverts into cortisol. When we add T, what do you think it does? If we give too much of it, it
kicks E2 off of its receptor and takes some demand off of DHEA. The more hormone we add
into the steroid pathways, the more the body has to try and do its job. Sometimes, it works great.
Other times, it is like trash rock. If you want more DHEA on your lab results, why not just give
them DHEA and pregnenolone? There is a lot of literature supporting this, even in women. For
me, I just give Cortef. I currently take 20 -25 mg per day in split dose. It works great and I have
not had a cold or herpes since I started it. I have a growing number of patients on it. Some love
it, others not. More than half appear to benefit.

Dr. Chen: Any potential problems with women who wish to continue, chronically, their
homeopathy and/or amino acids supplementation? This is a big thing in Santa Cruz. It is my
knowledge that homeopathy uses very dilute concentrations, and that some people even wonder
how patients get an effect if the concentration is so dilute. I'm sure you've run into women who
get started on a huge amount of amino acids to try to increase their brain neurotransmitter
concentrations, so am wondering how you feel about that.

Dr. Taguchi: Good question since this needs to be addressed. I think it depends on what the

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October 12, 2008

homeopathic prep is.

Dr. Ridley: I have been working with Marty Hinz at Neuroresearch for over 5 years. I am a huge
fan of AA replacement using his protocols. The other folks have not done their research in terms
of how dosing should be done and how assessments should be measured. His protocols work and
he would tell you that if you get the NTX balance corrected, hormone requirement goes down.
We know there is a connection between estrogen and serotonin with estrogen significantly
increasing the activity of serotonin. This may happen via neuron stability. I think it also happens
in the methylation pathway that is upregulated by E2 and controls the metabolism of serotonin.
Personally, 70% of all women are serotonin deficient and need replacement. But, I don't think
serotonin works as well without estrogen. In terms of homeopathics, it depends upon the
homeopathic [preparation]. I had a patient who used Sepia and it had a potent progestagenic
effect on her. So, yes, I think they can be quite powerful and possibly disruptive to [the] Wiley
[Protocol].

Dr. Taguchi: “AA" replacement = amino acid?

Dr. Chen: While I think pounding huge doses of amino acids will increase the brain's production
of neurotransmitters, I would think that the body has homeostatic mechanisms that would
eventually downregulate the enzymes involved in each step of synthesis. Since E affects brain
dopamine, serotonin, acetylcholine, and norepinephrine, via its effects at the transporter levels, as
well as enzymes such as monoamine oxidases, COMT, etc., I don't see how giving someone huge
doses of amino acids wouldn't affect WP.

Dr. Ridley: Again, EVERYTHING affects EVERYTHING - the tenet of functional medicine. If
you don't poop every day, it affects Wiley. It is folly to think that estrogen will fix serotonin
deficiency. IT WON'T!!! Most of us are NOT providing adequate feedback to CRH. It is why we
don't sleep. It is why we are depressed. It is why our thyroids have been turned down. It is why
we have issues with chronic inflammation, autoimmunity, cholesterol, hypertension, etc.
Estrogen can negatively feedback on CRH. So can cortisol. Cortisol is THE feedback, but most
of us have trashed it. Hence our chronic health issues. I have a patient I will present at
conference who required an estrogen level of 3000+ at her peak to get normal cycles, libido and
periods. 3000!!!!!!!! What happened? She is using estrogen and estrogen alone to try and
compensate for poor CRH feedback, poor neurotransmitter activity. It works, but she cannot stay
at that level. I have been trying to convince her for a year. Now, she gets it. So, I will spend the
next year weaning her down and introducing cortisone and neurotx support to her. If you haven't
read Marty Hinz's work at Neuroresearch, you really don't understand AA replacement and
neurotx chemistry. And if you have your Wiley patients on any of the antidepressants, you are
harming them and their Wiley [Protocol] far more than AA support ever could. To be continued
next month

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