ABC News on T.S. Wiley and the Wiley Protocol

T.S. WILEY: Am I a degreed scientist? No.
LYNN SHERR: Are you a degreed anything?
WILEY: Yes. I... I... attended a B.A. program in anthropology at a university in St. Louis.
SHERR: But you claim to have a degree in anthropology and in fact you never got that degree, did you?
WILEY: I'm not sure.

SHERR: We are. Webster College told us that the day Wiley posed for this commencement photo displayed on her website, she received only a blank piece of paper and never got a diploma.

When you earn a college degree, there is no difficulty proving it. That's part of the whole idea. And forgetting whether or not you did? Does that ever happen by accident?

The Truth About T.S. Wiley's Credentials
Followup on Wiley's Credentials
Newsweek Exposes Wiley's Non-Existent Degree
New York Times Scrutinizes Somers & Wiley Protocol

T.S. Wiley is Not "Prescribing"

T.S. Wiley is a confirmed college dropout:

  • consulting with patients apart from and without respect to their doctors,
  • listening to their symptoms,
  • on the basis thereof telling them precisely how to dose the medications prescribed by their doctors,
  • and then telling them to follow up with her on the results.

And she insists with rolling eyes that she's not "prescribing".

From a Wiley Protocol support meeting.

The Wiley Protocol: an analysis of ethical issues

The scrutiny continues in another peer-reviewed journal.

Menopause. 15(5):1014-1022, September 2008. Rosenthal, M. Sara PhD

The Wiley Protocol: an analysis of ethical issues.

Rosenthal MS.
Department of Behavioral Science, Program for Bioethics and Patients' Rights, University of Kentucky College of Medicine, Lexington, KY 40536-0086, USA.

OBJECTIVE: This review explores the ethical issues surrounding an unregulated protocol that is advertised to women through consumer books, the popular press, and the Internet, known as the Wiley Protocol.

DESIGN: A content analysis of relevant documents was conducted, followed by telephone interviews with investigators and former participants to verify facts.

RESULTS: The Wiley Protocol is an example of unregulated research involving potentially unsafe doses of bioidentical hormones applied to an unselected population of women. This protocol fails to use research ethics guidelines such as informed consent, investigator expertise, sound methodology, standardized data collection, and data safety monitoring.

CONCLUSIONS: Clinical ethics breaches include lack of full disclosure of risks, coercive influences, as well as misinformation about the study goals and safety. Breaches of professional ethics include conflicts of interest with respect to financial incentives, patient accrual, and inadequate standards of awareness and proficiency among participating investigators. It appears evident that the failure to regulate nutriceuticals and products of compounding pharmacy has provided the opportunity for these ethical violations.

More Testimonials

Women experimenting with the Wiley Protocol continue to report unfavorable results:

I have been on the Wiley Protocol for 6 months and am experiencing symptoms such as belly weight gain, hair loss, bloating, etc.

Being on the protocol (which i followed exactly) really messed up my endocrine system. I went off of it after 4.5 months because it was making me physically ill.

I have been on the Wiley Protocol three to four months now and I think that I am dying!!

These are women who have recently tried the Wiley Protocol. Any claims that the problems with the Wiley Protocol are due to product/pharmacy issues or any other excuse from years ago cannot possibly be true.

Not surprisingly, you're unlikely to get the full story from a Wiley Protocol support meeting:

I would suggest you attend a few of the Wiley support groups, if you have one in your area. Wiley desperately bad mouths people whom the protocol has made ill, as well as the doctors and pharmacists that refuse to work with her any more (and that, to me, pretty much says a lot about who she is). If she truly knew her protocol worked, and was secure in her knowledge base, she would explain why you are having the symptoms (the science behind it, etc) and not just bad mouth people [who] reported issues with the protocol (or not call them back to help them out).

In those meetings she will tell you what to do to relieve the symptoms you are reporting (without having lab work or knowing your history) and it seems she thinks it is okay to practice medicine without a license because she usually has one doctor on the conference call with her. However, please keep in mind that the doctor on the other side of the line also does not know you, does not know your labs, nor your history, and seems to feel that her license is not on the line for prescribing changes to your treatment without consulting your physician.

Interestingly enough, the support group I attended refused to give out the email addresses or the phone numbers of the other participants even after we all agreed we would like to share. We assume this refusal is because we were all having problems. We exchanged numbers in private, after the meetings concluded. Once we found out how many others were also having the same problems, the drop out rate began to flow. [emphasis added]

Other testimonials indicate that trying to hide adverse information from women on the Wiley Protocol isn't limited to support meetings:

My doctor literally said 'Don't read the Rhythmic Living or Wiley Watch sites.' Oh how I wish I [had]. But I wanted the easy answer. Who knew it would make my life more complicated? ... I'm afraid words like 'moron' and 'pile of drek' may come out of my mouth when describing the said inventor of the protocol.

However, some of the professionals are exhibiting ethics:

I just started working at a Wiley-certified pharmacy and am worried about these high doses I am dispensing to women.

Other recent testimonials:

I was on the Wiley Protocol for a month-June 2007 and have had nothing but problems since. I need to find some answers and get my life back.

I am a personal trainer, calorie counter, nutrition guru, etc. I was only on the Wiley Protocol for 6 weeks but have had permanent weight gain and hormone problems due to this AWFUL protocol. The sad thing is, my doctor was very knowledgeable in other areas, so I trusted 'him' when starting the Wiley Protocol.... I am still affected by this awful Wiley hormone regimen nearly 2 years later. I am planning to get liposuction since I have tried excessive cardio, dieting, other hormones, any other means possible to lose the weight gained on Wiley.

Every time I think about 'the book' (Sex, Lies, and Menopause), I feel like trashing it, burning it, selling it or just plain getting it out of my sight because I'm so embarrassed for being sucked in and don't even want it in my library. Now that I have a clear head, the propaganda in it is obvious. I feel stupid for following such a ridiculous scheme. But at the same time, I know how vulnerable i was. I was very sick. I couldn't make a rational decision to save my life, and this decision practically ruined it. I cannot imagine "pushing" through this for a year.

I gained 16 lbs on the Wiley Protocol, 8 lbs in the first month!! This occurred without changing my diet. Of course, Wiley told me in one of the support groups that it would come off itself and to hang in there with it as my body adjusted. I waited and the only thing that occurred (weight wise) was that I gained another 8lbs on top of the first. So much for my body adjusting to being given progesterone in excess.
...
By the end of the first month I had gained 8 lbs, but I was somewhat 'okay' with that if my joints were better and that was all the weight I would gain. No such luck, gained more and more (even though i was told by Wiley and Caren that it would go away soon). This 'input' from them was similar to Caren telling me that the linea negra was nothing to worry about and that it is 'your body adjusting'.

My sister started the Wiley Protocol last month. Recently things have come up that make me question its ethics and effectiveness.

I used the Wiley Protocol for a mere 6 weeks but had devastating problems. What started as an effort to boost my low estrogen became my journey through hell.

Ethical problems with the Wiley Protocol

Ethical problems with bioidentical hormone therapy
http://origin.www.nature.com/ijir/journal/v20/n1/full/3901622a.html
M S Rosenthal
Program for Bioethics and Patients' Rights, Department of Behavioral Science, University of Kentucky, College of Medicine, Lexington, KY, USA

Excerpt:

“A glaring example of unregulated and unethical research in BHRT is The Wiley Protocol, which became more widely known to the public through Somers' promotion of it as legitimate research.[39][56] The Wiley Protocol has involved over 1000 participants in the administration of 'a trademarked, patent-pending delivery system consisting of bioidentical estradiol and progesterone in a topical cream preparation dosed to mimic the natural hormones produced by [a 20-year old woman].'[41] This protocol emphasizes a 'rhythmic' dosing schedule using potentially unsafe high dosages of hormones.[39][57][58] Somers' book misrepresents TS Wiley, its lay investigator, as a respected and published scientist. Somers' book also serves as a recruitment tool for unwitting human subjects. This is a multicenter Phase II trial (with no record of Phase I testing) involving 129 study sites in 29 US states, and 2 study sites in British Columbia, Canada.[59][60] Since data is being collected and presented on women enrolled in this trial,[59][60][61][62] but has not been IRB approved (interviews: TS Wiley, and D Turner, 13 March 2007; J Taguchi, 15 March 2007), or monitored by an investigator with experience in scientific methodology or clinical research,[41] it does not meet criteria for regulated or ethical research.[37][63] There are no formal exclusion or inclusion criteria for patient enrollment (interview: J Taguchi, 15 March 2007), and the study population spans women aged 19 through 90, who may not understand that they are enrolled in unethical research.[64] Serious safety concerns about this protocol have been raised.[61][65] Co-investigators appear to be prescribers of this protocol who widely vary in training, ranging from physicians to massage therapists; and pharmacists who are contractually obligated to Wiley as a source of the compounded pharmaceuticals sold to participants of the protocol.[66] The study is funded by participants, who are paying for the protocol with their prescriptions. Typically, study agents should not be sold.[67]”

Fack Checking: T.S. Wiley on Homosexuality

A comment from a reader earlier today prompted me to look into the claims about homosexuality in Sex, Lies, and Menopause. What I found was the sort of appalling scholarship I've come to expect from T.S. Wiley.

This particular assertion caught my eye: “The first tier of stress on a population can turn baby boys into very unlikely reproducers and extremely creative individuals. We know this phenomenon as male homosexuality. These men could reproduce, but they probably won't. This is often the aftermath of war, when women are left during pregnancy to guard themselves in a vulnerable time. That's why we have had a population bulge of homosexuality after World War II. [68-71]“

References:
68. U.S. Census, 2000. Reported Same Sex Couples.
69. Kirby, David. The next generation: open-minded and well-adjusted, children with gay parents say their families are a gift. The Advocate 1999 June 22.
70. Lorde, Audre. How gay was the Harlem Renaissance? www.women in the life.com, 2000.
71. Committee makes recommendations for California schools. San Francisco Chronicle 2001 April 13.

That is certainly a curious selection of references.

Seasons Greeting From The Wileys

The following was left on my Wikipedia talk page earlier.

Happy Holidays

Here is what my grandfather from Russia taught me - those who love us, love us. Those who don't, may the good lord turn their hearts. But if he can't turn their hearts, he should turn their ankles so we can recognize them by their limp.

I hope you have a happy and healthy new year. And don't forget to soak your ankle. Neil Raden (talk) 04:00, 24 December 2007 (UTC)

UPDATE:

I saw that you added the above to Wiley Watch, presumably because you interpretted it as an insult, or at least something you could mock. Pity. I thought that for one day of the year we could lay down our weapons and just be civil. I guess I was wrong. Neil Raden (talk) 20:24, 25 December 2007 (UTC)

T.S. Wiley Sued For Unlawful Detainer

T.S. Wiley's landlord wants her, her husband Neil Raden, and family out of the house they're renting from him according to an article on the Santa Barbara Noozhawk.

The owner of the 27-room mansion in Santa Barbara, Lanny Ebenstein, says he wants them gone because their $9000 rent payments were habitually late. He says the lease expired in June and yet, even after a 90-day extension expiring September 30, they refuse to leave. He also claims they and their relatives have been sued 45 to 50 times for nonpayment of debt.

Wiley and Raden dispute these claims and allege that they are being illegally evicted out of retaliation, but Santa Barbara Superior Court Judge William McLafferty threw their arguments out of court as irrelevant. They say they will appeal the ruling.

Meanwhile, one of my sources informs me that they are planning to move to Santa Fe at the end of the month.

UPDATE:
Indeed T.S. Wiley and Neil Raden are no strangers to the Santa Barbara Superior Court system. I searched the court's records and found 30 separate cases naming them as defendants over the last eighteen years -- ten against T.S. Wiley, eleven against Neil Raden, and nine naming both as defendants, including Mr. Ebenstein's. That's about one lawsuit filed against either or both of them per seven months.

UPDATE - 11/20/07:
It appears they've reached an understanding with their landlord. Neil Raden forwarded me the following e-mail:

From: Eric Berg
Sent: Monday, November 19, 2007 10:03 AM
To: T.S. Wiley
Subject: Talking points

"We reached a resolution with Ebenstein on Friday where we will be remaining in the house under the current lease terms."

I think that's it.

Eric Berg
Attorney At Law
Hatch & Parent, A Law Corporation
[remainder trimmed]

"Talking points". Hmm.

Somehow I doubt that Mr. Ebenstein would agree to the prior lease terms after receiving a ruling in his favor and given the animosity that's been aired out. And I know that "current" and "prior" need not denote the same thing.

(Given the closing "I think that's it", I wonder if there may have been other "talking points" -- whether this e-mail was edited before it was forwarded to me.)

UPDATE - 11/21/07:
I've corrected some minor inaccuracies and adjusted some wording for precision.

Fact-Checking: T.S. Wiley on Homeopathy

T.S. Wiley claims that science definitively validates her ideas and points to the abundance of footnotes in her book, Sex, Lies, and Menopause. Indeed, among the 218 pages of main text you will find 1756 footnotes (actually endnotes). Open the book to any page and you can expect to find about sixteen footnotes staring back, defying your scrutiny. The actual references consume another 84 subsequent pages -- nearly 40% as much as the book's main content.

It's almost as if the intent were to 'Shock and Awe'. If so, it's been successful up to a point. Over the last couple of years we've done some fact-checking and looked into a number of these references. But we haven't yet reported anything... the sheer volume makes it a daunting prospect.

But that's a poor excuse. So without further ado, let us now start looking into T.S. Wiley's science.

T.S. Wiley to Appear on Fitness Radio Show

T.S. Wiley is scheduled to appear on the radio program, "Dr. Fitness and the Fat Guy", next Thursday, September 13.

It's an Atlanta radio show about weight loss and fitness. You can tune in alongside us to learn what T.S. Wiley has to say on the subject. The show airs live at 7:30 PM EDT, 4:30 PM Pacific.

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