On April 19, 2007, Wiley appeared as a witness before the Senate Special Committee on Aging to give testimony at a hearing in which the safety and oversight of BHRT and compounding pharmacy were discussed.[14]
Wiley has been criticized for promoting her version of BHRT without proper qualifications or scientific evidence. On October 11, 2006, Erika Schwartz, Diana Schwarzbein, and five other MDs who have worked with BHRT during their careers 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 Wiley Protocol is “scientifically unproven and dangerous” and that Wiley has no medical or clinical qualifications;[7][8] other criticisms of the protocol itself have stated that the levels of hormone are dangerously high.[9][10] Wiley has claimed on her website and in speaking engagements that she earned a B.A. in anthropology from Webster University in 1975. On November 27, 2006, Newsweek reported that Webster has no record of this degree.[11] Wiley’s bio page was then changed to “Pending B.A. in Anthropology, Webster University, 1975″ and then again to “Attended the B.A. Program in Anthropology, Webster University, 1970-1975″. ABC News reported on February 16, 2007, that, according to Webster, she received only a blank diploma.[12][11][13]
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 level 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 theorizes 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.
Wiley is listed as co-author of three scientific journal articles along with biochemist Dr. Bent Formby between 1998 and 2001.[3][4][5]
T.S. Wiley is the author of Lights Out: Sleep, Sugar and Survival,[1] and Sex, Lies and Menopause.[2] She writes about women’s health, particularly sleep and hormonal issues, hormone replacement therapy and bioidentical hormone replacement therapy. Wiley has developed her own version of BHRT known as the Wiley Protocol, though she has been strongly criticized for lacking the relevant credentials and potentially putting women at risk with an unproven, untested intervention that uses possibly dangerously high doses of hormones.
Concerns have been raised that serum levels may not be an acceptable marker for transdermally administered hormones, that some women have experienced significant side effects while following the protocol and have stopped using it, and that the dosages used are too high and not physiologic.[4][5]
T. S. Wiley and Suzanne Somers have been criticized by some physicians for their advocacy of the Wiley Protocol. A group of seven doctors issued a public letter to Somers and her publisher, Crown, in which they state that the protocol is “scientifically unproven and dangerous” and cite Wiley’s lack of medical and clinical qualifications.[6][7] The Wiley Protocol has been criticized as unethical due to the start of a Phase II clinical trial with no Phase I, a lack of approval by an institutional review board, a lack of an experienced scientific investigator leading the trial, no inclusion or exclusion criteria and no evidence that the study population has been told that the research has not passed an ethical review,[8][5] as well as concerns over conflicts of interest regarding financial incentives.[5]
The Wiley Protocol uses bioidentical hormones, specifically estradiol and progesterone. Hormones are applied transdermally, using an oil-based skin cream for topical administration.[1] Doses of the hormones vary throughout a 28-day cycle that is designed to mimic the hormone levels and changes of a young woman who experiences regular menstruation, with each hormone cycling and peaking at separate times throughout the period.[2] The protocol is promoted as differing from conventional hormone replacement therapy in several ways:
The use of plant-derived hormones that are identical to endogenous hormones found in the body, rather than the synthetic derivatives of conventional hormone replacement therapy such as premarin[1]
A dose that varies over a 28-day cycle rather than remaining static[1]
Topical rather than oral administration[1]
The protocol also includes a follow-up program to monitor the serum of the bioidentical hormones.[1]
Wiley has stated that in her opinion, the most important aspect of the protocol is the specific schedule and levels of the hormone doses rather than their bioidentical nature.[3]
The Wiley Protocol is a controversial form of bioidentical hormone replacement therapy (BHRT) devised and advocated by T. S. Wiley. The protocol claims to relieve the symptoms of menopause but is also promoted as increasing overall health through the recreation of a pre-menopausal woman’s monthly hormonal cycle using rhythmic doses of hormones standardized to a uniform purity. Wiley claims the protocol is a step beyond the symptomatic treatment of conventional hormone replacement therapy.
The protocol has been criticized by members of the medical community for lacking proof. In addition there are criticisms about the dosages of the hormones used, Wiley’s lack of qualifications to design the protocol, and ethical problems with the clinical trial that is being run to test it. The protocol has not been empirically verified as safe or effective.
In the episode “My Balancing Act” of the TV series Scrubs, Elliot was unable to name Whipple’s Triad.
The use and significance of the criteria have evolved over the last century as our understanding of the many forms of hypoglycemia has increased and our diagnostic tests and imaging procedures have improved. Whipple’s criteria are no longer used to justify surgical exploration for an insulinoma, but to separate “true hypoglycemia” in which a low glucose can be demonstrated from a variety of other conditions (e.g., idiopathic postprandial syndrome) in which symptoms suggestive of hypoglycemia occur but low glucose levels cannot be demonstrated. The criteria are now invoked far more often by endocrinologists than by surgeons. The reliability of the criteria for this purpose has been a subject of contention among physicians.
The criteria date back to the 1930s, when it had been discovered that a few patients with hypoglycemic symptoms (such as shakiness, syncope or sweating) due to hypoglycemia could be cured by surgery to remove an insulinoma. However, it had also become apparent that a large proportion of people with symptoms suggestive of hypoglycemia had no need of surgery. Diagnostic testing was rudimentary: beyond a crude assay for reducing substances as an indirect measure of blood glucose, there was no way to measure hormones and metabolites such as insulin, and no imaging procedures for internal organs such as the pancreas.
Allen O. Whipple was a well-known surgeon who had pioneered pancreatic surgery. In an article entitled “The surgical therapy of hyperinsulinism”, in J Internat Chir 3:237-276 (1938), he proposed that no pancreatic surgery to look for an insulinoma be performed unless these criteria were met.