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]”

37. Levine RJ. Ethics and Regulation of Clinical Research 2nd edn. Yale University Press: New Haven, 1988.

39. Suzanne Somers debates doctor. Transcripts.Larry King Live: CNN, A Time Warner Company; November 16, 2006.

41. What is the Wiley protocol? The Wiley Protocol. Accessed March 16, 2007, at http://www.thewileyprotocol.com.

56. Somers S. TS Wiley: rhythmic cycling. In: Ageless: The Naked Truth About Bioidentical Hormones. Crown Publishers: New York, 2006, pp 154–165.

57. How hard is it to get the Wiley protocol? The Wiley Protocol. Accessed March 17, 2007 at http://www.thewileyprotocol.com.

58. Schwartz E, Schwarzbein D, Rosensweet D, Randolph Jr CWR, Northrup C, Murray J et al. Letter to Managing Editor, Crown Publishers,October 11, 2006. Posted at: http://drerika.typepad.com/notepad/2006/10/letter_to_suzan.html.

59. Finding a Wiley protocol doctor or prescriber. The Wiley Protocol. Accessed March 17, 2007 at: http://www.thewileyprotocol.com.

60. Participate in data gathering. The Wiley Protocol, Accessed March 17, 2007 at: http://www.thewileyprotocol.com.

61. Feig S, Hynote E, Speight N, Magaziner A, Miranda RA, Schachter MB. Summary of the American College for Advancement in Medicine May 2005 Conference. Evid Based Complement Altern Med 2005; 2: 413–419. | Article |

62. Somers S. Effects of aging; bioidentical hormones and aging; sex, sleep and stress; Dr Julie Taguchi: breast cancer; TS Wiley: rhythmic cycling.In: Ageless: The Naked Truth About Bioidentical Hormones. Crown Publishers: New York, 2006,pp 86–87;105–9; 18–29; 54–65; 232.

63. Food and Drug Administration (FDA). Drugs for Human Use 21 C.F.R., Part 312.60.

64. Why the Wiley protocol? The Wiley Protocol. Accessed March 17, 2007 at: http://www.thewileyprotocol.com.

65. Our Wiley protocol history. RhythmicLiving.org. Accessed March 27, 2007 at: http://rhythmicliving.org.

66. Wiley Systems. Wiley Protocol Registered Pharmacy Registration Agreement 2007.

67. Food and Drug Administration (FDA). Drugs For Human Use 21 C.F.R., Part 312.7(d).