The Wiley Protocol

Department of Behavioral Science, Program for Bioethics and Patients' Rights, University of Kentucky College of Medicine, Lexington, KY 40536-0086, USA.
Menopause (New York, N.Y.) (Impact Factor: 3.36). 07/2008; 15(5):1014-22. DOI: 10.1097/gme.0b013e318178862e
Source: PubMed


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

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    ABSTRACT: To describe the prevalence of menopausal hormone therapy (HT) in 2008 and trends over the last 17 years in an Australian population. Data were obtained from nine representative population face-to-face interview surveys of the South Australian population from 1991 to 2008. The surveys used consistent method and quality control procedures. In 2008, demographic data, HT use and eight dimensions of health, using the SF-36 health survey questionnaire, were measured. Participants Over 3000 South Australian adults were interviewed in their own home by trained health interviewers in each of the surveys; in the 2008 survey, 1555 women participated, of whom 953 were over age 40. After a peak in use in the 2000 survey, HT use fell from 2003 and has continued to decline in 2008. In 2008, current use over age 50 of registered conventional HT products is now 11.8%, with a further 4.0% using non-registered alternative 'hormonal' products. Current HT use is highest between the ages of 50 and 59 years, where 13.4% use conventional HT and 7.7% use unconventional alternative hormones. Use of these unregistered hormonal products was rare in previous surveys. Median and mean length of conventional HT use were 10.0 and 10.5 years, respectively. HT users continued to have a demographic profile similar to those in previous surveys, i.e. they were better educated, employed, partnered, had a higher income and were less inclined to use complementary and alternative medicines. There has been a continuing decline in both the overall prevalence and length of use of conventional HT from 2003, probably in association with negative media about HT. Of medical concern is that about one-quarter of women using HT around menopause now chooses unregistered hormonal mixtures that are untested for long-term safety and efficacy.
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