T. S. Wiley

T.S. Wiley is the author of Lights Out: Sleep, Sugar and Survival, and Sex, Lies and Menopause. She writes about women's health, particularly sleep and hormonal issues and hormone replacement therapy.

Writings and beliefs

Wiley's main thesis in Lights Out is that light is a physiological trigger that controls dopamine and hormones like cortisol. Wiley posits that with the extension of the natural day through artificial lighting, rest at the hormonal levels is rarely adequate for optimum biological needs of the body. In her view, this results in both fatigue and unnatural appetite, which leads to weight gain, exhaustion and disease.

Wiley argues that the body's responses are cyclical, reflecting the seasons of the year, and that the body's needs vary seasonally. According to Wiley, during the winter months the body needs more sleep, and carbohydrates should be restricted as they would have been naturally during hunter-gatherer times.

In her follow-up book, Sex, Lies and Menopause, Wiley argues that imbalances in hormones like estrogen, progesterone, insulin, cortisol, and prolactin, among others, are the root cause of age-related diseases, including cancer, heart disease, diabetes, stroke, and Alzheimer's. These imbalances, Wiley claims, can be attributed to deviations from humankind's natural state—artificial light, sleeping too much in the summer and not enough during winter, and eating fruit during winter months—and indirectly to women's liberation, insofar as it has lead to the increased use of contraceptives, deferral of child bearing into the 20s and 30s, less frequent childbirth, and reduced breastfeeding. The solution Wiley offers for women is to recreate the youthful levels and monthly cycles of estrogen and progesterone in the body, in effect fooling nature into thinking that the organism is still young and reproductive and should not be culled from the ecosystem. In this way age-related diseases may be prevented or cured, and perhaps even death may be averted indefinitely. Wiley argues that conventional hormone replacement therapy is ineffective and dangerous, advocating instead cyclical dosing of bioidential hormones. Appendix I of the book describes a specific dosing schedule for estrogen and progesterone.

Subsequent to the book's publication, her hormone regimen became known as "The Wiley Protocol" Becauses compounding pharmacy is not uniform, Wiley created the Registered Pharmacy program to insure consistency and purity in the compounded products. These pharmacists must agree to a contract stipulating compounding methods, materials, packaging and recommended pricing. No royalties are paid to Wiley, but her company does supply the packaging materials with The Wiley Protocol trademark. Training for the pharmacies is handled by a third party.

Wiley offers educational cources for physician for which they receive CME (Continuing Medication Education) credits essential for maintaining their licenses to practice.

Wiley has been criticized for trying to monetize the Wiley Protocol, but neither she nor her company receives royalties or commissions from the pharmacies or the doctors. Pharmacies pay a one-time fee of less than $600 to enroll and the cost of Wiley packaging amounts to less than 10% of the cost of the materials. Through these polices, the Wiley Protocol costs less than half, sometimes much less than half, other compounded hormone therapy treatments.

Doctors have no obligations. They can prescribe the Wiley Protocol through any Registered Pharmacy and do not have to register or certify with Wiley, though she does encourage them to take the traing course and purchase to clinical provcedure manual. Wiley's critics use these transactions to cast the scheme in a sinister light, but it barely borders on commerce.

Suzanne Somers advocates the Wiley Protocol and describes her experience with it in her book Ageless: The Naked Truth About Bioidentical Hormones.

Wiley is listed as co-author of three scientific journal articles along with Dr. Bent Formby, spanning a four-year period

Controversy

On October 11, 2006, Erika Schwartz, Diana Schwarzbein, and five other MDs issued a public letter to Suzanne Somers and her publisher, Crown, criticizing Somers' endorsement of Wiley's protocol. In the letter they alleged that the protocol is "scientifically unproven and dangerous" and that Wiley has no medical or clinical qualifications. The doctors who signed the letter have themselves weak credentials in hormone replacement therapy, some of whom actually were under probation or suspension of their medical licenses at the time. The motivation for the letter was partially to grab some publicity, as it turns out Schwartz was actually prescribing the Wiley Protocol at the time.

A number of women have reported adverse effects from the Wiley Protocol, including hair loss, brain fog, fatigue, weight gain, and depression. Wiley insists that the protocol is effective and alleges that these women were noncompliant, that they had problems before starting the protocol, and that the product was faulty due to pharmacy incompetence. Wiley has repeate4dly, and publicly, asked these women and/or their doctors to come forward with actual evidence, but none have done so.

Recent Developments

On April 19th, 2007, Wiley was a panelist at the Senate Special Committee on Aging and gave testimony about compounding pharmacy, bioidentical hormone replacement and poor performance of the NIH through the Women's Health Initiative in spending $700+ million dollars studying hormone replacement therapy and discovering only what was already known - that synthetic hormones dosed in a static rhythm are dangerous.

The University of Texas at Tyler is beginning an observational, longitudinal study of the Wiley Protocol in 2007. There are other studies starting as well, comparing the outcomes of the Wiley Protocol with other therapies.

Wiley herself does not participate in these studies and receives no monetary benefit.