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COM
December 20, 2008

The Wiley Protocol

Clinical Practice Newsletter
Our mission in this newsletter is to inform health care professionals about bio-mimetic
hormone replacement therapy and to promote healthy aging and optimal
patient management.
In This Issue
In The Trenches: • In the Trenches- Page 1

Doctor to Doctor
Important Items- Page 2
Doctor to Doctor •
• What the Future Holds- Page 2

! • Evidence For Us- Page 3

• Greening Update- Page 3
Three doctors who are pre-eminent practioners of the Wiley
• Main Article- Page 4
Protocol discuss the finer points of clinical practice guidelines

No On HPV Vaccine
based on their experiences prescribing the Protocol. The doctors:
• Calendar Of Events- Page 5
Courtney Paige Ridley, M.D. an OB-GYN from Dallas, Texas;

Seminars and Conferences
Yun-Ching Chen, M.D. an internist from Santa Cruz, California;
• Testimonials- Page 5
and Julie Taguchi, M.D, an oncologist from Santa Barbara
• New Products- Page 6
California have been involved with the Protocol for several years.
• Coming Soon- Page 6
Dr. Chen: What do I do with women who have low E levels, still fairly
Pod-casts and More
high FSH (clinically behaving like low E), but very high SHBG? I'm The Body Politic- Page 6
•
already making sure that they do not have excess thyroid, not on any
• In The Trenches Continued-
oral phytoestrogen supplements, and eating some carbs. Pages 7 & 8
• Main Article Continued-
Dr. Taguchi: I do not follow FSH levels any more because they seem to
Pages 9 & 10
normalize on WP. 24 hour urines can help see E being absorbed and
processed, but can it tell "hyperexcretion or metabolism”?

Dr. Ridley: Maybe I am wrong here, but I have not been tracking FSH levels. I don't think I have
seen serum E2 levels consistently elevated enough to create that kind of feedback to suppress
FSH. Hyperexcretion is a possibility but can be assessed with 24 hour urine. If elevated, then
cobalt can be considered to down-regulate P450 activity in the liver leading to that
hyperexcretion. Blood spot analysis may prove valuable here. That remains to be seen.

Dr. Chen: I do not agree that FSH levels normalize across the board on WP. I'll agree that it
usually gets better on WP, but I have several women who still have significantly elevated FSH
despite an E level that is in-range for WP. I would have to say that several women do not feel
better until E gets high enough to suppress their FSH. I routinely check it since it is part of the
feedback loop.
Cont. On Page 7

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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.
December 20, 2008
Important Items
Stem Cells May Solve Mystery of Early Pregnancy
Breast Cancer Protection
ScienceDaily (Sep. 20, 2008) — The answer to why an early
pregnancy seems to protect against breast cancer could rest
with a decrease in stem cells found after animals have given
birth, said researchers at Baylor College of Medicine in a report
that appears in the current issue of the journal Stem Cell.
Women who have children young, at least before the age of 30,
reduce their risk of developing breast cancer, said Dr. Yi Li, a
professor in the Lester and Sue Smith Breast Center at BCM.
The most dramatic reduction in risk occurs in women who have
their first children before the age of 24. However, the
mechanism by which these early pregnancies provided
protection has proved elusive. More
Loss of Sleep, Even For a Single Night, Increases
Inflammation in the Body
ScienceDaily (Sep. 4, 2008) — Loss of sleep, even for a few
short hours during the night, can prompt one’s immune system
to turn against healthy tissue and organs. A new article in the
September 15th issue of Biological Psychiatry, by the UCLA
Cousins Center research team, reports that losing sleep for
even part of one night can trigger the key cellular pathway that
produces tissue-damaging inflammation. The findings suggest
a good night’s sleep can ease the risk of both heart disease
and autoimmune disorders such as rheumatoid arthritis. More
Changes in Sex Steroids Associated with Menopause
ScienceDaily (Oct. 2, 2008) — A study in the Oct. 1 issue of the
journal Sleep shows that the increased rate of follicle
stimulating hormone (FSH) change that occurs during
menopause is associated with increased objective sleep
duration but poor subjective sleep quality. Findings from the
sleep profiles created for the study's 365 participants indicate
that postmenopausal women had deeper sleep and longer total
sleep time than premenopausal women. More
Daily Rhythms in Blood Vessels May Explain Morning
Peak in Heart Attacks
ScienceDaily (Nov. 11, 2008) — It's not just the stress of going
to work. Daily rhythms in the activity of cells that line blood
vessels may help explain why heart attacks and strokes occur
most often in early morning hours, researchers from Emory
University School of Medicine have found… “The aim of our
research was to look at the circadian pattern of both endothelial
function -- the ability of blood vessels to relax -- and the
abundance of the progenitor cells" says Ibhar Al Mheid, MD, a
postdoctoral cardiology researcher at Emory. More
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December 20, 2008

EVIDENCE FOR US
No On Mammograms
T.S. Wiley, a revolutionary thinker, has been saying it for years: if you have the cancer that’s
going to kill you, it will. If you don’t, it won’t. Not every cancer is a death sentence.
Mammograms only exacerbate the problem, detecting cancers that would disappear if left
alone and in the process exposing breast tissue to radiation. She recommends against
mammograms. Now the New York Times has said it too in this November 25, 2008 article, in
which it was reported that a six-year study of breast cancer in Norway found more invasive
cancers in women screened every two years than in women who were not screened until the
sixth year. The study suggests that a significant number of cancers in the control group
regressed and went away without treatment, but would have been detected with more
frequent screening.

The study also noted that even invasive cancers may sometimes go away without treatment
and in larger numbers than anyone ever believed. If the results are replicated, it could
eventually be possible for some women to opt for so-called watchful waiting, monitoring a
tumor in their breast to see whether it grows. “The issue is the unintended consequences
that can come with our screening,” a Harvard physician said, meaning biopsies for lumps
that were not cancers or, it now appears, sometimes treating a cancer that might not have
needed treatment. “In general we tend to underplay them.” In her book, Sex, Lies and
Menopause, T.S. Wiley argues that statistically breast cancer facts tell us that breast cancer
kills half of all women diagnosed with it within five to ten years after diagnosis no matter how
early it’s detected. Women only increase their odds of getting breast cancer with annual
mammograms.

Hormone Replacement Therapy and Heart Attack Risk: Danish

Study Provides New Information
ScienceDaily (Oct. 2, 2008) — It's not what you take but the way that you take it that can
produce different results in women who take hormone replacement therapy (HRT),
according to new research on the association between HRT and heart attacks, published
online in Europe's leading cardiology journal, the European Heart Journal. The study is the
largest to look at the effects of HRT since the Women's Health Initiative trial was stopped
early after finding that HRT increased the risk of women developing a range of conditions
including breast cancer and thromboembolism. More

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. In Santa Barbara County, you can recycle the
syringes if they are in a milk container!

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December 20, 2008

The Begining of the End

No on use of the HPV Vaccine
We suggest that the rush to mandate use of
the Human Papilloma Virus (HPV) vaccine is
premature, given the lack of long-term data,
uncertainty about safety, and enormous
market-driven pressures for short-term gain
over unknown long-term costs.
First, some information: HPV is the most common sexually transmitted infection in the
United States. Overall an estimated 6.2 million new HPV infections occur every year
among persons aged 14--44 years. Of these, 74% occur among those aged 15--24
years. Modeling estimates suggest that >80% of sexually active women will have
acquired genital HPV by age 50 years.
The CDC Advisory Committee for Immunization Practices (ACIP) issued the
recommendations for HPV vaccination in March 2007. The CDC adopted these
recommendations on June 25, 2008. Ironically, this set of recommendations led the U.S.
Citizenship and Immigration Services to adopt vaccination requirements effective July 1,
2008 mandating that all applicants for citizenship be vaccinated with the quadrivalent
vaccine. Any vaccination recommendation made by the ACIP for persons living within the
U.S. becomes a requirement for immigrants.
Gardasil composition includes Polysorbate 80, a surfactant used in pharmacology to
deliver certain drugs or chemical agents across the blood-brain barrier. Concerns about
the estrogenic effects of Polysorbate-80 on pre-adolescent girls and pregnant women
have been raised, referring to a Bratslavian study of rats exposed to Tween 80,
suggesting that treatment with Tween 80 accelerated maturation, prolonged the estrus
cycle, and induced persistent vaginal estrus. Ovaries were without corpora lutea, and had
degenerative follicles, resulting in infertility.
Cervarix uses a proprietary Adjuvant System (AS04); the risk of side effects is being
assessed but has not been completed. In late June 2008 GSK said it had responded to
outstanding questions about Cervarix raised by the U.S. Food and Drug Administration
but had decided to augment its application with results from a further Phase III study,
called HPV-008. Data from this trial are expected to be submitted to the U.S. regulator in
the first half of 2009 and an FDA decision on the application is anticipated up to six
months later. Cervarix is approved in Europe but U.S. sales will be pivotal to its
commercial success.
A UK researcher believes that not enough is known about the effects of the Cervarix
currently being given to teenage girls throughout the UK vaccine on children with pre-
existing medical conditions and with weakened immune systems from their existing
medication. Grace Filby, who won a Churchill Fellowship for her research into phage
therapy, stated:” We simply do not know whether the vaccine interacts with other
medication or medical conditions, and the manufacturers have not studied it yet. This
could be a very valid reason why some families and schools might hesitate or opt out."
Cont. on Page 9

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December 20, 2008

CALENDAR OF EVENTS
The 2009 schedule for the Wiley Certification Seminar -- Two Days Back on Earth—is
January 17-18, April 11-12, July 11-12, and October 10-11 in Glendale, CA. 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 Clinical
Practice Guidelines Manual (17 CME credits).
Two Days Back on Earth Seminar Specials for 2009: If you refer a colleague to one of the
“Two Days Back on Earth Seminar” in Glendale, California, then we’ll give you 50% off your
registration. The course provides the maximum 17 credit hours in the category of 1PRA. The
person you refer would be required to purchase their conference at the full conference rate
If there isn’t a registered pharmacy in your state registered to produce the authentic Wiley
Protocol, we will give you a pass to attend the seminar in Glendale, California. (Materials not
included.)

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.

2009 conferences include:

•A4M-April 24-25 Orlando Florida
•ACAM-April 30- May 3 San Diego Ca.
•A4M-Dec 10-12 Las Vegas Nevada

The 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.

Testimonial
This seminar has reminded me about the beauty of nature, and how we as humans
are supposed to be in harmony with nature. It is when we try to alter this destiny is
when disease occurs. Thank you, T.S. Wiley, for reminding me how I love science, this
earth, our existence, and why I became a doctor to begin with.
Loraine Diego, LA

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December 20, 2008

OUR NEW PROTOCOLS

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 anti aging medicines, 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) original, biomimetic 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.

NEW AND COMING SOON

We JUST introduced the Wiley Protocol 60+ to be used for women over 60 that have never
been on HRT/BHRT for a limited three month cycle. The WP pharmacies have the information.

In early 2009 there will be dosing modifications for the Wiley Protocol Men’s hormone creams
and for the Wiley Protocol women’s testosterone cream. Your patients will receive the dosing
modifications on our color-coded bags. The hormones will now come with burgundy, blue and
orange plunger syringes. The contents will be the same high-grade hormone creams. In
addition all caps will now be black.

Pod-casts coming by doctors who have attended the Two Days Back on Earth
Seminar!
Go to the Wiley Protocol website for details.

THE BODY POLITIC

The tort lawyers have started a class action suit against Ortho
Evra, manufactured by Johnson & Johnson, for injuries and deaths
caused by excessive levels of estrogen delivered via patch. Check
out this website: http://www.webnichemarketers.com/ortho/?
AFID=30273&SID=dg#back

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December 20, 2008
In the Trenches- continued
Dr. Chen: I've had several women who get immediate flare-ups of their genital herpes
when I have them use a small amount of E on labia/vagina to try to improve absorption.
Any thoughts on mechanism? My thought was that perhaps it was such a large dose
locally that it down-regulated TH-1 immunity via its anti-inflammatory effects (so
decreased INF-gamma), possibly allowing the virus to re-activate. Is the only choice
here just to increase E dose on the limb?

Dr. Ridley: In certain susceptible individuals with altered cortisol response and changes
in CRH, what is supposed to be adaptive becomes more chronic. Localized application
of estrogen affects CRH changes leading to a predominance of humoral vs. cell-
mediated immunity increasing susceptibility to this type of infection, especially one
housed locally in the nerve ganglia.

Dr. Taguchi: So, I assume if a patient continues to have outbreaks, then you just don't
utilize the labia etc. Does this also explain the yeast infections that some women get on
p4?

Dr. Chen: I'm not sure what you mean, specifically, [Dr. Ridley]. Are you suggesting that
local E application up-regulates B-cell immunity (humoral), and at the same time down-
regulates T-cell immunity, thereby allowing [the] herpes virus to escape T-cell cytotoxic
effect? I'm not sure that B- and T-cell immunity are necessarily on a see-saw. I'm going
to do a literature search into this. I am trying to convince some of my patients to try
using a little E on the anal tissue in these women...I'll let all of you know what happens!
My feeling regarding [Dr. Taguchi’s] question of yeast infection induced by P is that the
excess P shifts the vaginal pH, making it more alkaline and allowing yeast to thrive. I
typically only see this when I have patients use part of their P vaginally (days 19-22).

Dr. Ridley: Read page 326 of From Molecules to Man - Effects of the Stress System on
the Immune/Inflammatory Reaction. This just scratches the surface, but it explains my
answer. I continue to read this amazing book. My knowledge remains rudimentary at
this point so I apologize if I misinterpret…I am a little concerned about the switch to anal
application. Remember, HSV is dermatomal. Be careful which dermatome is involved
with these patients. Just moving to the anus may activate there --- OUCH!!!! P4
increases the glucose content of the vagina thereby increasing yeast growth in
susceptible patients with borderline overgrowth....

Dr. Chen: We need to please discuss serum vs. saliva testing with regard to WP. I have
had several women come to me who had been managed by some compounding
pharmacist previously, with saliva tests via ZRT or Diagnos-techs labs. They come to
me with obvious menopausal symptoms, huge hot flashes, etc., and yet their saliva
tests invariably show that they are either "estrogen dominant", and/or that their E/P ratio
is just fine.
Cont. on Page 8

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December 20, 2008
In the Trenches- continued
I've compared their saliva tests to baseline serum tests, and they ALWAYS have very
low E levels, and sky high FSH levels (last one I looked at FSH was 140). These women
ALWAYS feel tremendously better when I start them on WP. If the saliva test results truly
reflected the level of these hormones in the tissues, then from the women I've seen, it is
certainly not enough to even make a dent in the feedback loop, or FSH would not be
sky high!

Dr. Taguchi: Oh, a very hot topic. I would like Dr. Ridley’s opinion and Dr. Zava's too.

Dr. Ridley: We haven’t heard from Dr. Zava yet, I hope this isn’t permanent. I hope not
permanently because the questions he raises are good ones. My own view is that
topical hormone distributes into the capillary and interstitial/3rd spaces first. This allows
it to get to the saliva so readily and to the tissues perhaps measured by blood spot.
Serum levels are low because so little of the hormone actually makes it into the venules.
That being said, some women have good serum levels suggesting less delivery into the
tissue space or interstitium and more into the venous return. Then the liver takes over
and I am seeing aggressive excretion in some of these patients. Bottom line is, we will
have to gather data on all compartments in those who are doing well in addition to those
having difficulty to see if we can correlate compartment distribution similarities.

Dr. Chen: Yes, it's high time we do salivary vs. plasma studies on women on high doses
of P.

Dr. Chen: Several of my women (myself included) have had either hair loss on WP and/
or perhaps the hair count is not lower, but that the hair is now much finer and less
coarse, "wispy" (according to my patient who is a hairdresser). Should I be replacing
their T to see if it helps? E levels are typically ok here.

Dr. Taguchi: Yes. I have had hair loss and attribute that to either too much p4 or the shift
in p4 levels, or there is the E to T ratios. I think T needs to be replaced, but levels are
important.

Dr. Ridley: Yes but do not forget the effects of these hormones on the thyroid. You really
have to look at more than T4 and TSH here.

Dr. Taguchi: What else? Definitely T3. I am afraid that too much T3 may worsen hair
loss if the T3 levels are low normal.

Dr. Chen: These are women who have normal TFTs.

Dr. Ridley: If you are not checking the entire T3 chemistry including rT3, fT3 and total
T3, you are missing the effects of CRH up-regulation of the D3 enzyme and the
development of subclinical hypothyroidism…
To be concluded next season

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December 20, 2008
No on HPV Vaccine- continued
No data exist on administration of quadrivalent HPV vaccine with vaccines other than
hepatitis B vaccine; the CDC states that quadrivalent HPV vaccine is not a live vaccine
and has no components that adversely impact safety or efficacy of other vaccinations.
Judicial Watch, in a June 2008 press release, reported that there had been 10 deaths
since September 2007 and 140 serious reports, 27 of which were categorized as life-
threatening. This release was based on raw data submitted to VAERS. Media attention
was focused on the potential for life-threatening events to occur as a result of
administering the vaccine. A review of the Judicial Watch report concluded it was based
on unconfirmed submissions to VAERS. As of 30 June 2008, out of over 16 million
doses of Gardasil distributed in the United States, there have been 9,749 reports to
VAERS following Gardasil vaccination. Gardasil has less than half the average
percentage of serious reports. More
In June 2006, Merck's Gardasil was the first vaccine to be approved for the prevention
of infections with HPV. GSK's competing product Cervarix received EU approval in
September 2007. As these products are the first to allow prevention of a form of cancer
through vaccination, their approval generated huge public attention and resulted in
significant pressure on healthcare authorities to make the $360 three-dose Gardasil
regimen widely available to teenage girls. Although most cases of cervical cancer in the
developed world can be prevented through the existing pap smear screening programs,
the expensive HPV vaccination has been recommended and is reimbursed for teenage
girls across the US and Europe. Is this decision driven more by public pressure and by
the exciting opportunity to vaccinate against cancer rather than by real medical need?
More
How much money is in the current HPV vaccine market? Merck reported net sales of
$239.8 million in first quarter 2008, up from $30.2 million in first quarter 2007. Merck
reported sales in the third quarter of 2008 were $401 million. More HPV vaccines
present a huge commercial opportunity, with predicted annual cohort sales of $1.4
billion in teenage girls for the seven major markets by 2016 and a cumulative catch-up
opportunity in young women aged 13-26 that could add up to over $17 billion until 2016.
Merck has received priority review status from the FDA for its application to extend the
Gardasil license to include women aged 27 to 45. Cervarix approval is being held up by
the FDA's demands for further clinical data and may be delayed until 2010. This gives
Gardasil a larger window of opportunity to establish itself in the all-important US market,
where GSK's clinical delays have already allowed Merck a head start. In response, GSK
initiated a head-to-head trial of Cervarix and Gardasil in January 2008. Although its
main aim is to compare the vaccines' immune responses to HPV types 16 and 18 in
women aged 18 to 26, its secondary goal is to assess responses in those aged 27 to 45
- the same age range as in Merck's new supplementary biologics license application.
More
The May 2008 Harvard Law Review published a paper titled Toward a 21st Century
Jacobson v. Massachusetts, alluding to the 1905 case that is widely seen as the
foundation for state public health powers.
Cont. on Page 10

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December 20, 2008
No on HPV Vaccine- continued
The authors argue that a distinction should be drawn between vaccines that are
'medically necessary' (such as smallpox) and those that are 'practically
necessary' (such as hepatitis B and HPV, for which other preventive measures are
available but not widely used). “Updating vaccine law to distinguish between two
degrees of necessity, and thus better accounting for vaccines like those against HPV
and hepatitis B, is an important early step in that process.” The paper suggests that
current law and policy fail to acknowledge the implications of this distinction. More.

We don’t have efficacy data for the population to be served by the HPV vaccines. There
are many unknowns in the assessment of safe use. There are huge profits to be made
in selling the HPV vaccines over the short term without knowing the long-term effects. Is
this medically necessary?
The New England Journal of Medicine published an opinion raising the basic questions
we need answered about use of the HPV vaccine. How long will protection last? Will
boosters be required? Exactly how effective will the vaccine be? Does it make sense to
target only one sex in prevention strategies against a sexually transmitted infection?
How will HPV vaccination affect screening practices? Since the HPV vaccines protect
against only two of the cancer-causing types of HPV, women must continue to be
screened for cervical lesions. Vaccinated women may feel protected from cervical
cancer and may be less likely than unvaccinated women to be screened.
A cost-effectiveness analysis in the same issue concluded that under certain
assumptions, vaccinating 12-year-old girls is associated with an incremental cost-
effectiveness ratio of $43,600 per quality-adjusted life year (a measure of both the
quality and the quantity of life lived after a medical intervention) gained, whereas adding
a catch-up program for older girls and women is not cost-effective. The assumptions,
however, may not be valid; for example if the protection of the vaccine wanes after 10
years vaccination is much less cost-effective and screening is more effective than catch-
up programs. (See New England Journal of Medicine.)
We don’t know enough to answer these questions. We won’t know enough to answer
these questions and many more for a very long time. You choose.

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