T.S. Wiley Testifies Before the Special Committee on Aging at the US Senate

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Author and medical theorist shares expertise on menopause and bio-identical hormone replacement therapy and how the Safe Compounding Drug Act of 2007 would severely restrict access to commonly compounded medications that many patients rely on, especially bio-identical hormones for women.

The choice of the molecule, the dosage, and timing of the onset of therapy are the most important variables in the search for safe and effective HRT and the WHI spent almost a billion dollars and never approached any of the most important questions

T.S. Wiley testified on April 19 before the Special Committee on Aging at the United States Senate in Washington D.C. She presented her expertise and experience with menopause and bio-identical hormone replacement therapy, and the changing landscape of women's health in later years, among other research. Wiley is a medical theorist in the field of Darwinian Medicine or "environmental endocrinology" and a writer and researcher on the use of hormones, particularly in postmenopausal women.

Wiley addressed the fact that the Safe Compounding Drug Act of 2007 would severely restrict and possibly deny access to critical medications and give the Food and Drug Administration the power to:

  • Broadly eliminate the availability of many critical, commonly compounded medications that many patients rely on (most especially bio-identical hormones for women).
  • Determine when compounded medicines are needed - a decision that has always been and should always be made by doctors.
  • Restrict the compounded medications the doctor can prescribe even if he or she determines the need for them.

"Among those left with little or no choice will be menopausal women and andropausal men; the autistic community; individuals living with HIV/AIDS; infants and young children with conditions like gastroesophageal reflux disease (GERD); hospice and nursing home patients; people who are extremely allergic or sensitive to fillers, dyes, and additives in medicines, and head trauma victims whose lives and minds can be saved by a compounded bio-identical hormone," Wiley said. "Please don't let this happen."

T.S. Wiley is the author of "Sex, Lies & Menopause," Harper Collins, 2005, a landmark work where a doctor, a philosopher, and a scientist prove that by postponing marriage and motherhood, women have accelerated the aging process, resulting in earlier menopause and, ultimately for thousands, earlier death. The book also examines the introduction of the birth control pill in the early 1960's and the impact of not breast-feeding our young.

There are over 40 million women between the ages of 40 and 60 in the U.S. About 25 million women worldwide enter menopause annually. It is estimated that by the year 2030, that number will increase to 47 million women per year. Since 1900, in the developed countries, the life expectancy of women has increase from age 47 to well over age 80, however, the average onset of menopause has remained at 50 as recorded for the last 150 years. That means, overall, women are living at least thirty years longer than they did at the turn of the century.

"Given the evidence that the symptoms of menopause, which can begin for women as early as their late thirties, are the same as the daily challenges the elderly face - that we become, in fact, old, when our hormones start to plummet - we can probably assume we're going to be sick, too, if we aren't already," said Wiley.

Wiley said that menopause, and andropause in men, are states of hormone depletion akin to the failure of Type I diabetics to produce insulin from their own pancreas. "Type I diabetics take a bio-identical molecule of insulin, using a short needle, through their skin, dosing it as their bodies would have produced it - after a meal, depending on what the meal consisted of, and they live long, pretty comfortable, healthy, productive lives. Yet medicine refuses to acknowledge the obvious-that the replacement of sex hormones in the same manner might put a serious dent in the diseases of old age."

Wiley's address to the Committee pointed out that the Women's Health Initiative (WHI), now the "gold standard" regarding hormone therapy, never looked at hormones, only drugs with "hormone-like" effects that were dosed in a regimen far from that of human replacement. Since this study, everybody seems to know estrogen causes cancer. She asks, "Do we know that, or, have we just been told that?"

Since the National Institutes of Health (NIH) stopped the Women's Health Initiative (WHI) in 2003 because the synthetic hormones - Premarin and PremPro were deemed too dangerous, the common assumption among women using bio-identical regimens is that they are doing something "safer." However, Wiley points out that the synthetics may have caused the harm reported, not just because they weren't bio-identical hormone molecules, but because of the way they were statically dosed. Perhaps, bio-identicals, currently dosed in the Standard of Care mode, may, too, be in need of study and improvement for safety.

"If estrogen and progesterone, or even testosterone, caused cancer, all young women would be dead. They're full of these hormones. So if logic tells us that estrogen doesn't actually cause cancer in and of itself, then there must be more to the story--like what kind and how much estrogen and when to take it," claims Wiley.

In Wiley's opinion, the failure of the WHI trial is partially due to the lack of understanding of the biology of the reproductive and menopausal state as well as, the indiscriminant choice of study subjects without well defined entry criteria, such as on the average enrolling subjects 12 to 15 years into menopause. She also questions the administration of drug molecules that are not natural to women's bodies as compounded versions of plant-derived hormones could be.

"The choice of the molecule, the dosage, and timing of the onset of therapy are the most important variables in the search for safe and effective HRT and the WHI spent almost a billion dollars and never approached any of the most important questions," said Wiley.

Furthermore, researchers Grady and Rubin looked at 85 percent of the world's data on estrogen and cardiovascular effects and found that the positive cardiovascular effect of estrogen in decreasing blood pressure and lipid profiles was unparalleled by pharmacological agents. Wiley asks if just lack of hormones explains why the rate of heart attack among women in this country is ten times less than it is in men until menopause or, if possibly the epidemic of breast cancer from forty on in women?

She also asked, "If hormone replacement consisted of real bio-identical hormones and was dosed to mimic the ups and downs of the blood levels seen in a healthy menstrual cycle of a 20 year-old woman, would all of the symptoms and disease states of aging decline or even, disappear?"

Beverly Hills, California-based medical practitioner, Dr. Christian Renna said, "I believe that T.S Wiley has made one of the most important discoveries in this century- a simple molecular mechanism that up until now, everyone else has missed."

Wiley's revolutionary discovery is the fact that it's the rhythm that matters in the accurate physiological replacement of hormones without side-effects for women in the second half of life. Wiley's findings may have important implications across a wide range of areas, from the treatment of menopause and anti-aging to all of the other diseases of aging such as heart disease and stroke, Type II diabetes, cancer and Alzheimer's disease.

The heart of Wiley's endocrine research in women is based in chronobiology and circadian rhythmicity. Her work rests on the simple fact that the circadian clock in every cell of every human body measures one spin of the earth, and the planet's constant companion, the moon, tracks 28 days 13 times in one revolution around the sun.

This light and dark cycle response on hormone receptors has evolved the 28 day menstrual cycle embedded in the physiological make-up of all women. That's why replacing hormones for women with static one-time-a-day, same-amount-every-day, dosing has been so unsuccessfully lethal that most women get sick and some women die whether they take synthetic or bio-identical hormones in such a non-natural regimen.

After years of research, T.S. Wiley developed a new method of hormone replacement therapy (HRT) called the Wiley Protocol® for women to use as a more accurate form of replacement for lost endocrine function. The Wiley Protocol is a patent pending delivery system consisting of bio-identical estradiol and progesterone in topical cream preparations dosed to mimic the natural hormones produced by a twenty year-old woman. The creams and their amounts vary throughout the 28 day cycle to mimic the hormone levels of youth. The Protocol is the only bio-identical hormone replacement therapy (BHRT) that has ever been developed under the scrutiny of a practicing oncologist.

Mounting evidence on the Wiley Protocol shows that it was the rhythm that was always missing in other regimens, and T.S. Wiley, Inc. is now waiting for a study number from the University of Texas at Tyler's Nursing School's IRB Committee. The proposed study is a longitudinal, observational study measuring many of the parameters of the WHI in women currently using the Wiley Protocol.

Wiley's testimony also mentioned that the National Institute of Neurological Diseases and Stroke is expected to approve and fund a national clinical trial this summer designed to see if high doses of compounded progesterone, a hormone that is present in all human brains, can help disrupt the rapid death of brain cells that frequently follows a trauma to the head. The quest for neuroprotection is driven not only by a deepening understanding of how injury and disease damage the human brain but, by a growing sense of urgency due to the almost 1,900 U.S. soldiers who have been treated for traumatic brain injury. Some Pentagon estimates have suggested that as many as 28 percent of the 1.4 million troops that have served in Iraq and Afghanistan may have sustained at least mild brain injury from the concussive effects of bomb blast.

At the same time, seventy-eight million baby boomers are reaching the peak years for stroke and degenerative brain diseases. Already, in the United States each year, 700,000 Americans suffer a stroke, and as many as 500,000 are diagnosed with a neurodegenerative disease (1.4 million suffer a traumatic brain injury). Such numbers have helped propel the search for an agent that could limit or hold off disability across a range of illnesses.

T. S. Wiley spent eight years in private tutorial in molecular biology with Dr. Bent Formby, PH. D., and has been in clinical private tutorial in oncology with Dr. Julie Taguchi since 1998. She has also been a guest investigator at Sansum Medical Research Institute, Santa Barbara, CA.

About Wiley Systems
Founded in 2003 in Santa Barbara, California T.S. Wiley is the developer of The Wiley Protocol®, a trademarked patent pending delivery system consisting of bio-identical estradiol and progesterone in topical cream preparations dosed in a rhythm to mimic the natural cyclic hormone levels replicated in serum blood produced by a twenty year-old woman.

The only bio-identical hormone replacement therapy (BHRT) that has ever been developed under the scrutiny of a practicing oncologist, The Wiley Protocol is only available at compounding pharmacies that have agreed to the standardized methods, materials, packaging and recommended pricing. In exchange, Wiley Systems™ provides intellectual property and sells pre-stamped 28WP logo-bearing packaging consisting of bags, labels and syringes in the branded colors of purple and green. The Wiley Protocol name, assures customers that they are receiving the authentic Wiley Protocol.

As a medical writer and researcher in chronobiology, environmental endocrinology and circadian rhythmicity, T.S. Wiley is the author of "Sex, Lies & Menopause," Harper Collins, 2005 and Lights Out: Sleep, Sugar and Survival," Pocket Books, 2000. Wiley's CME accredited seminars on the natural history of endocrinology are attended by physicians from all over the world who are learning about The Wiley Protocol. Wiley's revolutionary discovery that it may be the rhythm that matters in the accurate physiological replacement of hormones may have important implications across a wide range of areas, from the treatment of menopause and anti-aging to all of the other diseases of aging such as heart disease and stroke, Type II diabetes, cancer and Alzheimer's disease.

Contact:
Kristin Gabriel, Director of Marketing Communications
T.S.Wiley, Inc.
O: 323.650.2838; C: 213.840.6978
E: kgabriel @ thewileyprotocol.com
http://www.thewileyprotocol.com

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