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VIEWPOINT
Bioidentical Hormones: Ethics and Misinformed
Consent
M. Sara Rosenthal, PhD
The term “bioidentical hormones” was introduced by
Jonathan Wright, MD, a practitioner who prescribes compound-ed
hormones from botanical sources.1 Wright used “bioidentical” to
communicate his still unsubstantiated claim that plant-derived
hormones are “identical” in molecular structure to
human hormones. The necessary structural crystallographic data
demonstrating this do not exist, which is why the term bioidentical
remains misleading. In the peer-reviewed literature, “bioidentical” is
described as a “pseudoscientific neologism,” and
the risks are presumed to be similar to patented hormones.1,2 Despite this, prescribers of bioidentical hormone replacement
therapy (BHRT) cite Wright’s claim as fact and make additional
unsupported claims.1
Suzanne Somers introduced BHRT to the patient population with
the publication of Ageless: The Naked Truth About Bioidentical
Hormones, based on interviews with BHRT purveyors.3 Several
professionals quoted in her book are misrepresented as experts.1 Of
particular concern, the book endorses an unethical clinical trial
known
as the Wiley Protocol, misrepresenting its lay investigator as
a credentialed scientist.4 The Wiley Protocol places women of
all ages on unprecedented high doses of transdermal estrogen
and progesterone, compounded from botanical sources.4
In 2008, the FDA announced enforcement action against 7 compounding
pharmacies that were making misleading and scientifically unsupported
claims about the safety and efficacy of BHRT.5 The
FDA also concurred with the Endocrine Society that the term “bioidentical” is
a marketing term and not one of scientific or medical merit.4 Meanwhile,
the problematic term “natural” is attributed
to BHRT; proponents assert that “synthetic” hormones
are derived from an animal (conjugated equine estrogen) but that “natural” hormones
are derived from plants (even though all plant-based hormones
are synthesized from precursor compounds). The claim that an
animal source is synthetic while a plant source is natural is
self-evidently absurd. The term “natural hormones” refers
merely to “steroid hormones occurring naturally in women…and
not to phytoestrogens.”6 There
are, however, many FDA-approved transdermal estrogen and progesterone
products available, made
from plant-derived estrogen and progesterone as opposed to animal-derived
estrogen and progestin; such products are generally referred
to as FDA-approved “bioidentical hormones.”
Patients who self-educate cannot avoid misinformation; typically,
they will find in their Internet search several Web sites by
BHRT prescribers who appear to be credible, many of whom cross
practice boundaries, make false claims, have insufficient training,
and have serious conflicts of interest.1 To exacerbate matters,
celebrities with great influence on perimenopausal patients continue
to endorse BHRT as safer.
Of note, Oprah Winfrey was recently criticized in the June 8,
2009 issue of Newsweek for presenting an unbalanced perspective
on BHRT. On an Oprah show that aired January 29, 2009, the expert
guests included Suzanne Somers and Christiane Northrup, MD, a
BHRT prescriber. Somers demonstrated application of the Wiley
Protocol; Northrup repeated Wright’s unsubstantiated claim.
On a Webcast following the show (posted on www.oprah
.com), Northrup added that “[bioidentical] is not a marketing
term, despite what you may have heard.” On April 21, 2009,
a Dr. Phil show on hormone therapy presented purveyors of bioidentical
hormones as experts.
The doctrine of informed consent supports the principles of autonomy
and beneficence. Autonomy-based obligations require that patients
must have informed consent in order to make necessary decisions
that enable self-determination. Genuine informed consent requires
full disclosure of all risks and benefits, decision-making capacity,
and voluntariness. Patients who base their decisions on false
claims or biased statements by experts with clear conflicts of
interest do not have informed consent. Barriers to decision-making
capacity include education, literacy, and numeracy; many patients
cannot decipher medical facts from fiction.
Beneficence-based obligations require that clinicians maximize
benefits while minimizing harms and that they disclose all potential
risks and benefits. Thus, clinicians who make false claims about
BHRT are breaching beneficence. Presenting their own clinical
observations as fact to patients is not the same as reporting
validated science. Complementary and alternative medicine practitioners
who present BHRT as an “alternative” to the standard
of care are also misleading patients, since providing hormones
to patients, regardless of the source, is not an alternative
to conventional hormones, especially when they are promoting
non–FDA-approved formulations that are more expensive.7
The marketing of BHRT presents specific challenges to professional
ethics. Clinicians who sell their patients books they have authored
on the topic or their own brand or formulation of botanical-based
hormones and those who prescribe over the Internet clearly violate
standards of professional ethics.
From a research ethics standpoint, any clinician who is prescribing
the Wiley Protocol—even at the patient’s request—must
understand that he or she is a coinvestigator of an unethical
and unregulated trial and is thus in violation of core research
ethics guidelines for human subjects research.4 Furthermore,
physician and pharmacist support of a clinical trial developed
by an investigator with no scientific or clinical credentials
raises questions about their professional ethical duty to have
standards of awareness and proficiency.4
In conclusion, the ethical use of BHRT revolves around re-educating
the patient as part of the informed consent process. When prescribing
hormone therapy to an appropriate candidate, the clinician has
an obligation to first explain that there is no scientific evidence
to support that bioidentical hormones are “identical” to
human hormones. Correcting this false perception is important,
because if left uncorrected, the claim suggests that BHRT carries
no risks. All patients should be counseled about the differences
between oral and transdermal therapies, as well as the difference
between a progestin (eg, medroxyprogesterone acetate) and progesterone.
The established risks, benefits, and costs of each must be explained,
and clinicians should be mindful about being professionally influenced
by any particular pharmaceutical company.
Beneficence-based obligations require clinicians to present the
established risks associated with all hormone products, regardless
of their source; so-called bioidentical hormones cannot be presented
as safer if there is no evidence of this. Clinicians should invite
patients to bring in literature they’ve read on hormone
therapy, so that the clinician has an opportunity to correct
false information and false perceptions. Ultimately, a presumption
of misinformation should begin all clinical consultations with
perimenopausal patients who request, or are assessed for, hormone
therapy, while a “new normal” of setting aside time
for correcting misinformation should become part of the consent
process.
The author reports no actual or potential conflicts of
interest in relation to this article.
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M.
Sara Rosenthal, PhD, is Director, University of Kentucky Program
for Bioethics in Lexington.
References
- Rosenthal MS. Ethical problems with
bioidentical hormones. Int J Impot Res. 2008;20(1):45-52.
- Fugh-Berman A, Bythrow J. Bioidentical hormones for menopausal hormone therapy:
variation on a theme. J Gen Intern Med. 2007;22(7):1030-1034.
- Somers S. Ageless: The Naked Truth About Bioidentical
Hormones. New York,
NY: Crown Publishers; 2006.
- Rosenthal MS. The Wiley Protocol: an analysis of ethical issues. Menopause.
2008;15(5):1014-1022.
- FDA. FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs.
Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116832.htm.
Accessed July 7, 2009.
- Boothby LA, Doering PL, Kipersztok S. Bioidentical hormone therapy: a review.
Menopause. 2004;11(3):356-367.
- Cirigliano M. Bioidentical hormone therapy: a review of the evidence. J
Womens
Health (Larchmt). 2007;16(5):600-631.
[Editor’s Note: For more facts about FDA-approved “bioidentical” hormones, see the waiting room magazine developed by The Female Patient, “The Buzz on Bioidenticals,” online at www.femalepatient.com.]
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