WWW.THEWILEYPROTOCOL.

COM
Spring , 2009

The Wiley Protocol

Clinical Practice Newsletter
Our mission in this newsletter is to inform health care professionals
about biomimetic hormone restoration therapy, otherwise known as
bioidentical hormones, and to promote healthy aging and optimal
patient management.management.
In This Issue
In The Trenches: • In the Trenches- Page 1

Doctor to Doctor
Doctor to Doctor • Important Items- Page 2
• What the Future Holds-
! Page 2
Three doctors who are pre-eminent practioners of the • Main Article- Page 3

Who’s Really Writing
Wiley Protocol (WP) discuss the finer points of clinical

the HRT Research?
practice guidelines based on their experiences with the
• Evidence For Us- Page 4
day-to-day use of the Wiley Protocol. They have been
• Testimonials- Page 4
involved with the Protocol for several years. The
• Here Now- Page 4
doctors: Courtney Paige Ridley, M.D. an OB-GYN from

Pod-casts
Dallas TX; Yun-Ching Chen, M.D. an internist from Santa
• Calendar Of Events- Page 5
Cruz CA; and Julie Taguchi, M.D, an oncologist from

Seminars and
Santa Barbara CA. With this month, the 3-part series is Conferences
concluded. • Greening Update- Page 5
• New Protocols- Page 6
Dr. Chen: I have a patient who simply cannot tolerate • The Body Politic- Page 6
Progesterone (P) beyond 8 lines (P4 160 mg) BID, as it gives her • In The Trenches
horrible depression/anxiety symptoms. She continues to have Continued- Pages 7 & 8
normal 28-30 day cycles now that I have modified her P schedule, • Main Article Continued-
so that she has a peak of no higher than 8 lines, for the last 4 Pages 9
months. Is it really necessary for her to try to slowly increase P
dose back to [the] original dose?

Dr. Taguchi: No. I think you and she have done the best to maximize P4- she is
obviously getting it.

Dr. Ridley: I concur. I have a number of patients on the following P4 and they are fine,
1,1,2,2, 4,4,6,8,6,4,4,2,2,1,1.
.
Dr. Taguchi: Yes, I have several [patients] on 50 or 25 percent of WP.
Cont. On Page 7

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What the Future
Holds
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
Spring , 2009
IMPORTANT ITEMS
Is Rapid Transition Through
Menopause Linked To Earlier Onset
Of Heart Disease?
ScienceDaily (Jan. 28, 2009) — An evaluation
of 203 women as part of the multifaceted Los
Angeles Atherosclerosis Study (LAAS) found
that those who transitioned more quickly
through menopause were at increased risk for
a higher rate of progression of "preclinical
atherosclerosis" – narrowing of arteries
caused by the thickening of their walls. More
Estrogen Pills Can Benefit Women
with Metastatic Breast Cancer, Study
Finds
ScienceDaily (Dec. 24, 2008) — For breast
cancer survivors, the idea of taking estrogen
pills is almost a taboo. In fact, their doctors
give them drugs to get rid of the hormone
because it can fuel the growth of breast
cancer. So these women would probably be
surprised by the approach taken by breast
cancer physician Matthew Ellis, M.B., Ph.D.,
associate professor of medicine at Washington
University School of Medicine in St. Louis —
he has demonstrated that estrogen therapy
can help control metastatic breast cancer.
More
Hormone therapy may cut colorectal
cancer risk
Reuters Health (Jan 8, 2009) - The long-term
use of hormone replacement therapy, which
older women abandoned in droves following
the news that it may increase the risk of breast
cancer, may substantially cut the risk of
colorectal cancer, research shows.
The greatest risk reduction -- 48 percent --
was observed among women who had used a
combined estrogen plus progestin hormone
regimen for 2 to 5 years, the investigators
report in the latest issue of Cancer
Epidemiology, Biomarkers and Prevention,
published by the American Association for
Cancer Research. More
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Spring , 2009

Who’s Really Writing the HRT

Research?
The practice of medical ghostwriting took another
broadside as Republican Senator Charles Grassley,
Ranking Member of the Senate Finance Committee,
requested that Wyeth and its contractor, DesignWrite
!(a for-profit medical writing and education company),
turn over documents relating to DesignWrite’s role in writing research for
Prempro. The role of the company in soliciting of authors for the research articles
was also questioned.
In separate letters to Wyeth and DesignWrite Inc. Sen. Grassley asked the
companies to disclose payments that were made to prepare certain articles and for
information about how doctors were recruited to “place their names” on those
articles. The articles, published in peer-reviewed medical journals, involved Prempro
and other female-hormone-replacement therapies made by Wyeth. The inquiries
came as part of the Senate Finance Committee's examination of “medical
ghostwriting,” part of a broader probe into the influence of drug companies on the
health-care industry.

“Medical ghostwriting” according to the letters “involves marketing and/or medical

education companies that draft outlines and/or manuscripts of review articles,
editorials, and/or research papers. This information is then presented to prominent
doctors and scientists, particularly those affiliated with academic institutions, to
review, edit and sign on as authors, whether or not they are intimately familiar with
the underlying data and relevant documentation. In addition, it is not always
apparent in the publication that individuals and companies other than the
listed authors were deeply involved in the study and/or drafting of the final
manuscript.”

The Association of American Medical Colleges (AAMC) Task Force on Industry

Funding makes a clear distinction between ghostwriting and ethical collaborative
writing.
The requests came about as the result of a discovery process for litigation. Mr.
Grassley’s staff on the Senate Finance Committee released dozens of pages of
internal corporate documents showing the central, previously undisclosed role of
Wyeth and DesignWrite in creating articles promoting hormone therapy for
menopausal women as far back as 1997. Wyeth’s own documents showed that its
marketing staff had conceived, outlined, and contracted the drafting of hormone
replacement therapy research reports. The company then paid honoraria to the
scientists who agreed to sign on as authors of the report. The reports, some of which
were used as part of the HRT reviewing process, were then published in journals
such as Obstetrics and Gynecology and Primary Care Update for Ob/Gyns.
Continued on Page 9

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Spring , 2009

EVIDENCE FOR US
Estrogen Curbs Appetite in Same Way as the Hormone Leptin
ScienceDaily (Jan. 4, 2007) — Estrogen regulates the brain's energy metabolism in
the same way as the hormone leptin, leading the way to a viable approach to
tackling obesity in people resistant to leptin, researchers at Yale School of Medicine
report in the December 31 online issue of Nature Medicine. “
“We found that estrogen suppresses appetite using the same pathways in the brain
as the adipose hormone leptin,” said lead author Tamas L. Horvath, chair and
professor of Comparative Medicine and professor in the Department of Obstetrics,
Gynecology & Reproductive Sciences at Yale School of Medicine. More

TESTIMONIAL
“I've always sought to truly treat patients, using the numbers on
paper as an assist, not the truth about the patient.
Last weekend I met and studied with another free thinker, not
indoctrinated with years of medical school, yet strongly grounded
!in both the reality of what is and the science in print that tries to
understand it. T.S. Wiley and team presented a truly remarkable
two days - a way of thinking that was in some ways as important as Dr. Barnes' ‘Treat the
Patient’ directive.
We met at a planetarium, of all things. With state of the art electronics and visuals, we
were reminded graphically that we are a part of the universe.” Read more.
Richard S. Wilkinson, M.D., Yakima, WA

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

For a complete list of practitioner’s that have attended the seminar:

http://www.thewileyprotocol.com/sobi2/sobi2Task,search/Itemid,277/
Some of these are Alan Unell, Barbara Fischer, Barbara Winter, Bridgett Simon, Chris Renna,
Conrad Hicks, Darya Boland, Ellie Hynote, Ching Chen, Gowri Rocco, Kelly Austin, Leah
Morton, Deb Werenko, Patty Ryan, Robert Apgar, Valorie Davidson, Varsha Rathod, Stephen
Dalton, Roberta Beals, Fred Bloem, Mitzi Schardt, Delmi Behr, Konnie Yankopolus, Beverly
Gerard, Courtney Ridley, Bob Mathis & Rebecca Provorse.

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Spring , 2009

CALENDAR OF EVENTS
The 2009 schedule for the Wiley Certification Seminar -- Two Days Back on Earth—is April
18-19, 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. 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. The
Medical Educator Consortium designates this educational activity for a maximum of 17 hours
AMA PRA Category 1 Credit(s). ™
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 percent off
of your registration. 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, and you help us register one, we will give you a pass to attend the seminar in
Glendale, California. (Materials not included) Check our website for details.

If doctors attend one of the conferences where we exhibit, coupons for a 10 to 15

percent discount on the cost of the seminar are available. 2009 conferences
include:
•ACAM-April 30- May 3 San Diego Ca.
•A4M- Sept 11-12 San Jose 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.

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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Spring, 2009

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.

Let your patients know that using the syringes

has become even easier now that the black
caps are being used. Patient education tools
have been added to our website, with radio
interviews with doctors, pharmacists, and
women on the protocol, videos, and You-Tube
! interviews.
In addition we have added adjustments for the
WP for Men and the WP Testosterone for Women. You now can call in 25, 50, and 75
percent more testosterone for men with DHEA +1, + 2 and + 3. Women’s
testosterone is available in +1, +2 or +3 doses. Bags with labels reflecting this have
been created.
WP 60+ is also available through our registered pharmacies

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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Spring, 2009
In the Trenches- continued
Dr. Chen: What is the conversion between serum levels of transdermal Estrogen (E) vs.
a little bit of it vaginally? There is a local physician who is using the E cream on herself,
but was trying to use only 1 line E vaginally BID, and nothing transdermally (she was
trying to save cost).

She apparently recently had her blood drawn, and her E level was 800s. I told her T.S.
Wiley’s reasons for minimizing vaginal dosing (lack of pulsatility), but she was not
convinced. Did you ever compare blood levels of 1 line transdermal vs. vaginal? I even
feel there is a difference in terms of absorption going labially vs. vaginally. My own test
results indicated a blood level of high 200s when I used a total of 3 lines labially per day
(baseline day 12 E level of 58 with E+4), but then my E level went to over 900 when I
changed to using only 2 lines per day, but vaginally!

Dr. Taguchi: You answered your own question. Vaginal absorption is higher as it is
mucosal; these are the same findings I saw with Dr. Schwartzbein's patients taking oral
troches - [E levels of] 900-1200 - but the levels fall very quickly.

Dr. Ridley: Ditto.

Dr. Chen: My 21 year-old ballet dancer (I think you've all heard about her) has been off
the Protocol since 1/08, because it looked like she had finally spontaneously ovulated at
that time (after 1 year of WP and finally quitting dancing 4 months previous to
spontaneous ovulation). I have had her use the E part for days 5-12 ever since to try to
see if we can get her to ovulate again. She's ovulated only 1 more time recently, but
based on my calculations, it would have happened just BEFORE she got on day 5's E
dose. I told her to stop the supplemental E and try to get a roommate with normal
cycles, so that maybe they could cycle together. Any other words of wisdom there?

Dr. Taguchi: Not from me.

Dr. Ridley: Sorry, not enough info for me to answer this one.

Dr. Chen: I'd love it if we can come up with some guidelines on doing seasonal
adjustments. Maybe women don't need as much E in the winter. Maybe women need
more P in the summer (given the reversed E peaks I'm mostly seeing in the summer).

Dr. Taguchi: Definite seasonal effects.

Dr. Ridley: I definitely see seasonal effects but you cannot protocol them. Each person
has to be handled separately.

Dr. Taguchi: Yes. Funny, the one I know from experience is thyroid. I needed less during
the summer. I think showing and acknowledging the seasonal changes is a very big
step
Cont. on Page 8

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Spring, 2009
In the Trenches- continued
for doctors and medicine.

Dr. Chen: Any new suggestions on women who bleed only very lightly, but have great
levels per blood work? Bleeding is still on-time, but just barely a few spots. I have a few
women who have this pattern, despite being on the protocol for >1 year. I've already
checked pelvic U/S, which seems to be ok. I just can't figure out why they are not
vascularizing the endometrium properly.

Dr. Taguchi: How old are these women? How long in between menopause and [the
Wiley Protocol]?

Dr. Ridley: If I get any menstrual response that is appropriately timed, that is good
enough for me. If they are otherwise doing well, I do not care if they have the textbook
withdrawal. Most of my patients would just as soon not have a full period.

Dr. Chen: I am mainly concerned in these cases that other target organs such as breast
are getting appropriate E/P effect. I cannot help but wonder what else is happening in
other tissue sites if the endometrium is not vascularizing appropriately, i.e., can I
assume it is just a local phenomenon?

Dr. Ridley: If I get any vascular response, I feel we have achieved what we are looking
for. I agree there is this ideal menstrual period, but, I very rarely see it in my gynecology
practice. I don't think that just because her flow is light for 2 days instead of moderate
for 4-5 means her breast is responding improperly.

Dr. Taguchi: Yes, I agree with this too.

Dr. Chen: I find vaginal dosing is one sure way to get the plasma E levels up (though it
loses pulsatility), whether it's purely due to a bolus effect, or something else. By Dr.
Zava's logic, I'm not sure why vaginal dosing would NOT create the same problem of
sex steroids getting stuck in the capillary beds, as it is also going in on the arterial side,
just like normally ovulating women would secrete E/P into the arterial bed; and yet they
have good measurable plasma levels.

Dr. Ridley: The vagina is a very unique place in the human body. The vascular supply
there is immense. The only thing as close is the buccal tissues of the mouth. The
Europeans are way ahead of us in using the vagina as a location for application for
hormone. That is why you get such huge levels so quickly after application, just like you
do with sublingual. But, they come crashing down within 2-4 hours. So, unless you can
apply at least 4 times per day, your levels will be like a roller coaster and a lot of your
patients, a) won't be able to comply with that schedule or b) will get tired of applying
there and will complain of irritation after a while, particularly the older patients. That has
been my experience thus far. After 20 years of managing hormones, chasing levels has
proven meaningless. I am curious about salivary and capillary distribution mainly for
those that I have a hard time managing clinically.

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Spring, 2009

Who’s Really Writing the HRT Research?- continued

Ironically, the documents reviewed by Senator Grassley’s staff include a “publication
plan tracking report” by Wyeth showing 10 articles in which manuscripts were
completed by the company before they were sent to the putative author for review. Any
revisions were subject to final approval from the company, according to the tracking
report. Such activities would seem to run afoul of medical journal guidelines. The World
Association of Medical Editors, for example, says ghost authorship — which it defines
as a substantial contribution not mentioned in the manuscript — is “dishonest and
unacceptable.”
The issue of drug company influence on research is not new. Merck manipulated public
opinion on its blockbuster pain pill Vioxx by paying high-profile doctors to add their
names to scientific reports drafted by others, according to an article in JAMA.
In an article published on April 16, 2008 in JAMA, and his colleagues studied
ghostwriting by Merck by using about 250 court records from suits filed against the
company. Ross and his three coauthors all have served as consultants for the plaintiffs.
They found that for 16 of 20 early clinical trials on Vioxx conducted by Merck, the lead
published author is an academic, although an internal document lists a Merck employee
as writing a first draft. The JAMA researchers also found evidence that Merck had hired
companies to draft 72 scientific review articles, in one case paying a firm nearly $24,000
for a 20-page draft. Other documents show that Merck paid some doctors between
$750 and $2,500 to publish the articles under their own names.
“Putting someone as the first author is saying this is the person most responsible for the
study, who did the analysis, interpreted the data, and wrote the paper,” Mount Sinai's Dr.
Joseph S. Ross said. “It gives the appearance of sound, more rigorously
conducted science. It's just…wrong.”
But a Merck official said the academic authors were “intimately involved in the studies.”
These studies “document how one company, Merck & Co. Inc., apparently manipulated
dozens of publications to promote one of its own products,” Dr. Catherine D. DeAngelis,
JAMA editor in chief wrote in an accompanying JAMA editorial. “But make no mistake -
the manipulation of study results, authors, editors, and reviewers is not the sole purview
of one company. Such ghostwriting is widely practiced by drug companies as part of
their marketing efforts and some of the articles downplay the risk of drugs.”

Evidence has been steadily mounting that financial relationships with industry can have
significant effects on research: authors are not only more likely to favor a sponsor's
product but companies have insisted on suppression of unfavorable results or delayed
their publication. (More)

Readers do not owe journals trust. Instead, journals need to earn and maintain the trust
of their readers.

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