University Of Kentucky Medical School

Oct 18, 2009

university of kentucky medical school

Bioidentical hormone replacement therapy – Sunlight Readable Monitor – LCD Touch Panels

History

Bioidentical hormones were first used for menopausal symptom relief in the 1930s, after Canadian researcher James Collip developed a method to extract an orally active estrogen from the urine of pregnant women and subsequently marketed as the active agent in a product called Emmenin. It was supplanted on the market when its maker, Ayerst (later Wyeth Pharmaceuticals) began producing the more easily manufactured conjugated equine estrogens in 1941 under the name Premarin, and by 1992 Premarin was the most widely prescribed drug in the United States.

In the 1970s, research and reports indicating risks from synthetic conjugated estrogens were published. Investigation determined that the addition of a progestogen to estrogen treatment reduced the risks. As early as 1980, the British Medical Journal (now called BMJ) recommended oral bioidentical progesterone as an option when side effects from synthetic progestogens necessitated discontinuation of treatment. Starting in 1980, side effects caused by synthetic progestin use prompted more research into bioidentical progesterone. In May of 1998 the FDA approved Prometrium, an oral bioidentical progesterone product produced by Solvay Pharmaceutical.

Physicians John R. Lee and Jonathan Wright are cited as pioneers in the area of BHRT. Lee authored several popular books on BHRT and promoted custom-compounded BHRT with a goal of achieving what he thought to be a “natural hormone balance”. This practice is based on the use of saliva testing to establish where “deficiencies” existed, though in reality this practice is thought to be unreliable and dubious. Lee also believed that progesterone acted as a panacea and general health tonic for many health conditions, but Lee based his claims on anecdotal data rather than rigorous research, and there have been no clinical trials demonstrating this to be true. Wright also authored a popular book on BHRT and promoted a triple estrogen formula frequently referred to as “Triest” using estriol, estradiol and estrone; previous bioidential formulas used only estradiol. This triple formula was based on a single unpublished study whose conclusions did not take into account how estrogens are processed and excreted in the body; no follow-up was ever performed by Wright to confirm or extend these observations. Wright may have been the first proponent to use the term “bioidentical”, which is how he described unpatentable, plant-derived molecules that he saw as more ‘identical’ to human hormones. However, no structural crystalographic evidence has supports the idea that these molecules are actually identical to endogenous human hormones. When the WHI’s results on the unappreciated risks of equine estrogens were released, prescribers of BHRT used Wright’s terminology to promote presumed the difference and superiority of bioidentical molecules despite a lack of evidence. The appearance of a popular book written by actress Suzanne Somers in 2006 the term ‘bioidentical’ entered the popular consciousness as a “poorly understood new adjective” regarding hormone replacement therapy.

Custom compounded BHRT is a practice almost wholly restricted to the United States.

Terminology

There is no single definition for the term “bioidentical hormone replacement therapy” (BHRT). A “bioidentical hormone” is defined as a molecule identical to a hormone produced by the human body Though the term “bioidentical” has been used in FDA packaging inserts since before 1998, the FDA considers “BHRT” to be a marketing term, and does not recognize its use. The meaning “plant-derived” has also been attached to the term “bioidentical”, and it may also be used to mean that the hormones are “natural”; throughout the 1990s plant-derived, compounded hormones were referred to as “natural hormone therapy”. However, the term “natural” can be applied to all products where the principal ingredient is from an animal, plant, or mineral source, and both bioidentical and nonbioidentical hormones can be produced from the same plant sources. The publication of a book by Suzanne Sommers in 2006 popularized the term “bioidentical” and it became “a poorly understood new adjective in the field.”

“BHRT” is often used to refer to a set of diagnostic, prescribing, preparation, and marketing practices, which include compounding (the preparation of custom-mixed hormones by a pharmacist according to a prescription), saliva testing, and efforts to counter the effects of aging rather than to just to relieve the symptoms of menopause. This compounded BHRT package has been promoted by Suzanne Sommers, Oprah Winfrey and other proponents as safer and more effective than CHRT, though there is no evidence to support these claims. Compounded BHRT has been marketed on the internet by pharmacies which make unfounded claims for its safety and its effectiveness against a variety of conditions.

The lack of distinction between FDA-approved bioidentical hormones and compounded bioidentical hormones as part of a package that includes saliva testing and compounding has resulted in considerable confusion regarding exactly what BHRT is.

There are a variety of FDA-approved products made using bioidentical estrogens and micronized progesterone, used to treat symptoms of menopause:

Hormone class

Type

Brand names

Preparations

Notes

Estrogens

micronized 17 beta-estradiol

Estrace and others

Pill and vaginal cream

Vaginal cream for vaginal symptoms only; sourced from plants; estradiol is bioidentical until ingested and converted in the liver to estrone

Alora, Climara, Esclim, Estraderm, Vivelle and others

Patch

Sourced from plants

Estrogel

Transdermal gel

Sourced from plants

Estrasorb

Topical cream

Sourced from plants

Estring

Vaginal ring

For vaginal symptoms only; sourced from plants

Estradiol acetate

Femring

Vaginal ring

Estradiol hemihydrate

Vagifem

Vaginal tablet

For vaginal symptoms only

Micronized progesterone

Micronized progesterone USP

Prometrium

Pill

Prochieve 4%

Vaginal gel

Combined preparations

17 beta-estradiol and norethindrone acetate

Combipatch

Patch

Estradiol is bioidentical but the progestin is not

17 beta-estradiol and norgestimate

Prefest

Pill

17 beta-estradiol and levonorgestrel

Climara Pro

Patch

Uses

Main articles: Menopause and Hormone replacement therapy (menopause)

BHRT is used to reduce the symptoms of menopause. It is also promoted by some practitioners for anti-aging purposes, and as providing benefits beyond menopausal symptom relief, thus improving quality of life, though there is little evidence to support these claims.

Components and compounding

Typically, compounded preparations of BHs may include estriol, estrone, estradiol, testosterone, progesterone, and occasionally dehydroepiandrosterone (DHEA). They are promoted as natural, safer, and in some cases more efficacious than CHT, but there are no scientific studies to support these claims. Estimates from sales of bulk hormones for compounding suggest that more than one million women may be using compounded BHRT in the US.

Estrogens

Estradiol is the form of estrogen most predominant in the cycling woman while estrone is predominant in the postmenopausal woman, and is converted from other hormones, including estradiol. Because of the limited research into potency, delivery methods, and conversion of the various estrogens, it is difficult to establish a valid scientific understanding of compounded estrogen products.

The hormone estriol, produced during pregnancy, is frequently compounded into bioidentical preparations in the United States. It was thought to be a weaker estrogen with a more limited period of effectiveness than estradiol, though it has been demonstrated to be a strong estrogen in some ways. The compound was part of the United States Pharmacopeia prior to the need for FDA approval but the agency banned its use in 2008 stating that estriol would require an application for a new drug. Estriol is a commonly prescribed conventional treatment in other countries. Though initial research in the 1970s suggested potential usefulness, follow-up studies failed to confirm this potential.

Other hormones

Supplementation of testosterone to improve libido in post-menopausal women is supported by research. The risk is a potential reduction in HDL levels. There is no commercial source of testosterone for women in the US except for compounding pharmacies. There is little published data to support dosing, duration and method of administration, though a growing number of physicians are using clinical results and blood levels to guide their treatment.

Progesterone is used both orally and transdermally. Oral progesterone is micronized to increase availability, and is approved by the FDA to prevent endometrial hyperplasia in opposition to estrogen treatment. It also relieves menopausal symptoms, either alone or in combination with estrogen. It is more reliable in treating menopausal sleep disorders than synthetic progestins. Transdermal progesterone is often used as a component of compounded BHRT, but it has not been proven to reliably prevent endometrial hyperplasia, as oral progesterone has.

DHEA is an androgen precursor, and can be converted to testosterone and then to estrogens in the body. This may cause additional breast cancer risk, as with all estrogens. DHEA is sold over the counter in the US, and may be incorporated into compounded hormone preparations to increase well-being and libido, though scientific findings to support these purposes are inconsistent. Safety information about DHEA supplementation is scant.

Compounding

Compounding pharmacies use commercially available bulk drugs to create new formulations that differ in form or dosage from those manufactured on a large scale by pharmaceutical companies. In the US, the practice of pharmacy compounding is governed at the state level, while the FDA has regulatory authority over the compounded product. Some Internet-based compounding pharmacies understate harms and claim benefits of compounded BHRT beyond those that can be proved by evidence-based medicine. Many claims made by compounding pharmacies go far beyond those made by mainstream BHT practitioners.

Adverse effects

The benefits as well as adverse effects and risks are the same for bioidenticals as synthetic hormones.

Side effects of estrogens

Some of these common but serious side effects of estrogens include: breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, ovarian cancer, high blood pressure, liver problems, high blood sugar, fluid retention, enlargement of benign tumors (ibroids) of the uterus, a spotty darkening of the skin especially on the face, vaginal yeast infection.

Adverse effects of estradiol

See also: Estradiol#Adverse effects

Estradiol is only recommended for use for the shortest period of time and at the lowest effective dose due to its adverse effects profile. A range of adverse effects from use of estradiol can occur effecting the genitourinary system, breasts, cardiovascular, gastrointestinal, skin, eyes, central nervous system and other systems.

Administration

Hormones can be administered in a variety of ways, including skin and vaginal creams, pills, topical gels, vaginal rings and tablets, and transdermal patches. Though all preparations are molecularly identical before their use, estrogens administered orally are modified by the liver before entering the blood, while those entering through the skin are not. Creams and gels applied to the skin also enter the blood directly and without modification, but it is not clear how much is actually absorbed. Pharmaceutical compounding is frequently used to modify the dose, form, and additives of the preparations, based on the instructions from a health care practitioner.

Criticisms

The primary differences between CHRT and compounded BHRT as popularly promoted involve testing of blood or saliva-bound estrogen levels, use of individualized compounding rather than standard doses, dosing to attain certain levels in the body rather than to relieve symptoms, and the use of hormones for purposes other than relief of menopausal symptoms. Proponents of compounded BHRT have been criticized by many mainstream medical sources for making unsubstantiated claims about its effectiveness for a variety of purposes, and for promoting it as more safe and “natural” than CHRT.

Advocates for BHRT have claimed that commonly compounded BHRT preparations are not commercially available, which is not true. Customized compounding does not actually provide customized results since it is aimed at producing a single hormone profile, which has not been demonstrated to be better than CHRT and does not consider the rate at which individuals will differ in the activity, metabolism and excretion of the hormones.

Salivary testing and compounding

BHRT is frequently associated with testing of saliva to establish a baseline hormone level, and compounding of the substances by pharmacists, on the advice of doctors, to produce preparations and blood-levels of hormones that are individualized to the patients. There is no research that demonstrates there is any benefit to either of these practices. Though promoters of BHRT claim that saliva testing can be used to “customize” the level of hormones for individuals, and tests are used to determine which hormones are supposed to be deficient and require supplementation, there is no scientific basis to support the use of saliva testing as estrogens are secreted in pulses within and across days resulting in varying saliva levels. Certain compounding formulations also attempt to use a single profile for all women, with no evidence that a specific profile is beneficial in all cases and no recognition that women differ in their sensitivity to hormones and rate of metabolization. Customizing based on testing also does not account for much of the effects and synthesization of hormones occurs within tissues rather than in the blood, and therefore blood or saliva levels of hormones may not necessarily reflect actual biological activity. Other concerns include lack of evidence that samples are stable during storage and transportation, poor reproducibility of results, and considerable variability between assays. There are also no studies that link symptoms with blood or saliva levels of hormones. The FDA recommends instead adjusting hormone therapy based on the symptoms of the patient, and there is no reason to adjust the dosing or monitor patients receiving BHRT. Skeptics of BHRT have also pointed out that there is also no certainty regarding what level of hormones should be found in the body. The North American Menopause Society has supported warnings about the potential harm BHRT could cause, as it unnecessarily compounds drugs that are already FDA-approved in ways that lack an evidence base of safety or harm, a warning supported by the Society of Obstetricians and Gynaecologists of Canada.

Although promoted as a way of customizing treatment, hormone therapy does not require customization and the use of testing to determine the amount of hormones administered could result in the dose used being higher than the minimum recommended level to alleviate symptoms or the administration of unnecessary hormones to asymptomatic women resulting in greater risks to the patient. In addition, analysis of the material used to promote BHRT suggests that rather than basing hormone doses on saliva results, practitioners are actually adjusting the dose based on symptoms. Health practitioners customize the care of their patients on an ongoing basis by choosing the medication, dose and administration route individually, using approved medications that have a demonstrated safety record and are not subject to the errors and inconsistencies of custom-prepared combinations. In addition, the different bioidentical preparations result in mixtures with different strengths and practitioners using compounded formulations may be unaware of the total dose of hormones their patients receive.

Boothby, Doering and Kipersztok summarize the issue as being a poor effort to apply principles of pharmacokinetics to achieve individualized dosing for drugs that do not require it.

Saliva testing has not been shown to accurately measure blood-bound hormone levels. The FDA recommends the lowest dose of hormones that effectively relieve symptoms and does not recommend custom-compounding, blood or saliva testing.

Lack of evidence for claims

Bioidentical hormones have been advertised, marketed and promoted as a risk-free panacea that is safer than standard HRT. Literature reviews by private practitioners who sell bioidentical preparations suggest benefits and advantages in the use of BHRT over conventional counterparts, but there is significant skepticism over claims made about BHRT and there is no peer-reviewed evidence that compounded bioidentical hormones are safer or more effective than FDA-approved formulations or that they carry less risk. The United States Food and Drug Administration (FDA) warned that claims about compounded BHRT products are unsupported by medical evidence, unlike claims about manufactured, FDA-approved products. The chief medical editor of Endocrine Today called compounded BHRT a “marketing concept” with no scientific backing, and the FDA warned that pharmacies use these terms to imply that the drugs are natural and have the same effects as endogenous hormones. Some[who?] also claim that compounded BHRT can prevent or treat diseases such as stroke, Alzheimer disease, breast cancer and heart disease. There is no credible evidence to support these claims.[citation needed] Bioidentical hormones and compounded BHRT are expected to have the same risks and benefits as CHRT, though the latter benefits from years of study and regulation, while compounded BHRT has no scientific data to support claims of superior safety or efficacy. The following specific claims have been made for the effectiveness of bioidentical hormones and compounded BHRT, with varying evidence to support or contradict them:

Claim

Evidence

Bioidentical hormones fit precisely in human hormone receptors while conventional hormones fit “cockeyed”; this mismatch causes serious side effects

Synthetic progestins and endogenous progesterones have different binding affinities for different receptors depending on the model and animal used; these differing pharmacodynamics have not been associated with specific side effects

The body is unable to metabolize synthetic hormones

The biological half-life for synthetic hormones is between five minutes and two days

Lack of progesterone causes “estrogen dominance”, resulting in irregular or painful, heavy menses

Oral progesterone is no more effective than placebo at alleviating symptoms of premenstrual syndrome

Progesterone can counter-act stress, increase metabolism and decrease abdominal fat

There is no evidence to support weight loss due to progesterone

“Normal” levels of progesterone protect against breast cancer

The claim is based on a single study of infertile patients during child-bearing years; there is some evidence to support a link between hormonal treatment for infertility and a reduced risk of breast cancer, but these benefits may not translate to women seeking relief from the symptoms of menopause

Progesterone therapy can prevent cardiovascular disease and atherosclerosis, and raise good cholesterol

The use of micronized progesterone neither increases nor decreases cardiovascular risks

The side effects reported in the Women’s Health Initiative study were due to the synthetic nature of the hormones used

“Cardiovascular benefit has not been proven with micronized progesterone in observational or experimental research…a multicenter, caseontrol study was conducted in postmenopausal women aged 4570 years to examine potential differences in cardiovascular risk between the subtypes of synthetic progestins and micronized progesterone…Micronized progesterone and pregnane derivatives were not associated with an increased venous thromboembolism risk, whereas norpregnane derivatives…were associated with increased risk of thromboembolism…Thus, certain progestins are associated with increased cardiovascular risk, whereas pregnane derivatives and micronized progesterone neither increase nor decrease cardiovascular risk in the doses studied”

Proponents claim that bioidentical hormones, in addition to the demonstrated benefit of improving bone mineral density, protect the eyes and skin from drying out, regulate the menstrual cycle, improve mental function, improve blood cholesterol and reduce hot flashes and night sweats associated with menopause

There is no published evidence derived from controlled research that supports the claims of superior beneficial effects for bioidentical hormones as compared to conventional hormome therapy. Risk data have been published for conventional hormone therapy, and CHRT is not recommended to manage any chronic diseases, or for the prevention of cardiovascular disease

Estriol can decrease the risk of breast cancer

Estriol has been shown to cause breast cancer cell growth

Pharmacists use their expertise regarding bioidentical hormones to meet the needs of their clients and improve health outcomes

Compounding is a legitimate practice, but there is no evidence that clearly illustrates the benefits and risks of BHRT

In 2006 actress Suzanne Somers released the book Ageless: The Naked Truth About Bioidentical Hormones, which endorsed the use of bioidentical hormones. The book was criticized by a group of doctors who, though generally supportive of the use of bioidentical hormones, state that more research is required, and object to protocols mentioned in the book on the basis of their potential danger, as well as the lack of qualification of the promotors. Somers’ book may have raised the profile of BHRT for the growing number of menopausal women, but also may cause confusion in making unsubstantiated claims for BHRT, and in referring to bioidentical hormones as non-drug products with fewer risks. Bioidentical hormones have also been discussed on The Oprah Winfrey Show, with Somers as a guest.

Bioidentical hormone proponents Erika Schwartz and Kent Holtorf criticized a 2008 review of literature on bioidentical hormones for addressing only compounded bioidentical hormones, and not reviewing FDA-approved bioidentical products, which they believe added to the existing confusion. Michael Cirigliano and Judi Chervenak have stated in reviews of literature on BHRT that large-scale, peer-reviewed studies should be used to establish the safety, efficacy and beliefs about the use of bioidentical hormones.

M. Sarah Rosenthal, Director of the University of Kentucky Program for Bioethics and Patients Rights, has stated that she believes BHRT is an experimental therapy that is often prescribed by practitioners who sell the products, and are thus in an unethical position of conflict of interest. Rosenthal has also described problematic issues with BHRT including patients receiving information from popular books while lacking the scientific literacy to separate rhetoric from evidence about hormone replacement, illegitimate claims of a “big pharam” conspiracy to suppress bioidentical prescribing, the extra and unnecessary cost of the products that are often not covered by insurance plans, and the inaccurate depiction of bioidentical prescribing as “cutting edge science” rather than unproven alternative medicine.

“Natural” claims

Bioidentical hormones are frequently marketed as being “natural”, or more natural than conventional HRT. Natural can be used to suggest or emphasize a variety of different ideas – similarity with endogenous hormones, extraction from a plant-based source, and that the hormones are not manufactured or synthesized.

Endogeny – this meaning of natural implies that the hormones are molecularly identical to those found within the body. However, BHRT, like all types of HRT, is unnatural in that it opposes the declining levels of fertility hormones in aging women and medicalizes a normal stage of human life. In addition, most of the conjugated equine estrogens extracted from horse urine (such as Premarin) are converted to human estrogens once they enter the body.

Plant-derived – Women who purchase compounded BHRT are more likely to associate the term “natural” with the idea that the hormones are derived from plant sources. However, both bioidentical and nonbioidentical hormones are sourced from the same plants, generally soy beans or yams

Manufacturing – both bioidentical and nonbioidentical hormones are synthesized using the same chemical precursors; diosgenin is extracted from soy or yam plants, converted into progesterone and used as a hormone chemical precursor to create the final product. “Natural” is also used to promote the idea of being unmodified and containing the “goodness” of a pure substance but promotes them as purified substance, thus simultaneously drawing upon a scientific discourse.

The Harvard Women’s Health Watch, published by Harvard Medical School, states that the “natural’ part of the marketing of BHRT may be a euphemism for “unregulated” rather than safe and state that the term “natural” can technically be used to indicate any product with an animal, plant, or mineral source, and as such applies to hormones that are not bioidentical, including Premarin, as well as to the molecules extracted from soybean and yam sources.

Cost

Compounded BHRT is more expensive than conventional, FDA-approved HRT and is often not covered by Health Insurance plans.

Safety

Bioidentical hormones are expected to carry the same risks and benefits as their non-bioidentical counterparts though there have been no studies that directly compare compounded bioidentical hormones with their non-bioidentical counterparts. Hormones as used in CHRT have been studied for years and their risk, benefit, and effectiveness profiles are demonstrated through years of research.

In 2002, the Women’s Health Initiative study (WHI), which was designed to demonstrate additional benefits for hormone therapy, was terminated prematurely after preliminary data indicated increased risk of breast cancer, heart attacks and strokes in older women. The early termination of the WHI study, which used conjugated equine estrogens, and the subsequent publicity about these previously unappreciated risks led to a decline in prescriptions for CHRT. The results of the WHI were used by BHRT prescribers to promote bioidentical hormones as safer than the FDA-regulated preparations despite a lack of evidence; according to the FDA, the results found by the study apply to all estrogens. BHRT has since been strongly promoted as a natural alternative with fewer risks than CHRT, though there is no evidence to support this claim; the f. BHRT practitioners recommend the use of compounded products because they more closely mimic the composition and ratio of circulating hormones in a woman’s body than do commercially manufactured products.

The Endocrine Society issued a position statement that bioidentical hormones carry essentially the same risks and benefits as non-bioidentical molecules. The American College of Obstetricians and Gynecologists in February 2009 re-iterated its position from November, 2005 that there are no proven benefits in the safety or efficacy of compounded bioidentical hormones, nor are there any benefits in salivary testing of hormone levels or customized dosing of hormones. The Mayo Clinic states that there is no evidence that pharmacy-compounded BRHT is safer or more effective than conventional hormone replacement, and that some bioidentical hormones are already available in certain FDA-approved products. The American Cancer Society also stated that “natural” and “bioidentical” hormones present the same risks as synthetic hormone replacement therapy, such as heart disease, blood clots, strokes and an increased risk of breast cancer with long-term use.

The U.S. Food and Drug Administration has warned several pharmacies about making unsubstantiated claims about the safety and effectiveness of compounded hormone products. The North American Menopause Association has stated that compounded bioidentical hormones have not been approved by the FDA, so there is no guarantee of purity, potency, efficacy or safety, and that they may contain unknown contaminants. The Australian Menopause Society has similarly stated that there is no evidence that bioidentical hormones administered using lozenges are any safer than their approved counterparts. The International Menopause Society has stated “There are no medical or scientific reasons to recommend unregistered ioidentical hormones.”

In November of 2006, the American Medical Association adopted a policy requesting that the FDA better monitor and regulate bioidentical hormones, releasing an editorial stating that compounded bioidentical molecules were expected to have the same risks as conventional hormones until proven otherwise.

Erika Schwartz, author of The Hormone Solution (Warner 2002), and Kent Holtorf published peer-reviewed papers stating that there is evidence to support a superior safety profile for bioidentical hormones when compared to non-bioidentical hormones, as well as improved relief of postmenopausal symptoms, and better bone density and lipoprotein levels in the blood. Deborah Moskowitz, a Doctor of Naturopathic Medicine who works for a manufacturer of a bioidentical product, also published an article stating that bioidentical hormones are superior to non-bioidentical hormones in safety and effectiveness though this review was criticized for “[attempting] to demonstrate that BHRT has a good safety profile, but the data presented only serve to demonstrate similar risks to conventional HRT.”

Regulatory status in the United States

Compounded BHRT is almost solely practiced in the United States and many FDA-approved fomulations that are wholly or partially made of bioidentical hormones are available. Topical hormone preparations such as progesterone, estrogen and DHEA creams can be purchased in stores or over the internet, and are not regulated by the FDA as they are generally considered cosmetic.

When prescribed by a licensed practitioner, the compounding of bioidentical hormones is controlled by the state pharmacy boards rather than the FDA, and pharmacists are permitted to adjust the doses and delivery methods according to the prescription. However, the FDA does have authority over the compounded product. In 2001 the FDA surveyed a limited number of compounded preparations, including eight hormone compounds. All three estradiol products passed every test, however two out of five progesterone products failed at least one test of potency, content or uniformity.

In October 2005, manufacturer of both FDA-approved bioidentical and nonbioidentical HRT preparations Wyeth Pharmaceuticals filed a Citizen Petition with the FDA, asking for enforcement actions against compounding pharmacies which dispensed BHRT, and to investigate labeling and advertising guidelines. Soon after, the FDA took a number of enforcement actions against several primarily Internet-based pharmacies that were producing compounded BHRT, and in 2008, banned the use of estriol in the US. The FDA stated that they did not take these regulatory actions against compounded bioidentical hormones in response to Wyeth’s request, as that is not the purpose of a citizen petition. They said that they had an ongoing investigation when they received the petition. The FDA has acknowledged that they are unaware of any adverse events connected to the use of estriol but ordered pharmacies to discontinue its use. The agency’s Assistant Director of the Office of Compliance stated that use of estriol would require a permit for research and a new drug application. The FDA also stated that it has not approved any drug containing estriol and that no information has been submitted to the FDA regarding its safety and effectiveness. The FDA’s concerns over the marketing and use of bioidentical hormones were supported by the American Association of Clinical Endocrinologists. In response to the FDA’s actions, the International Academy of Compounding Pharmacists (IACP) enlisted thousands of women to join a letter-writing campaign to the FDA to reverse this action, citing Wyeth’s attempt as a “self-serving, and at times duplicitous, campaign to restrict patients access to alternatives to its own products”.

In November of 2006, the American Medical Association adopted a policy urging the Food and Drug Administration to survey compounded BHRT products for purity and dosage: to maintain a registry and require mandatory adverse event reporting by manufacturers and compounding pharmacies related to bioidentical hormones; to mandate the inclusion of uniform patient information including warnings and precautions regarding bioidentical products; and to prohibit use of the term “bioidentical hormones” unless the agency has approved the preparation.

On July 18, 2008, a US Appeals Court issued a ruling stating that new drug approval processes should not be applied to compounded drugs that complied with established guidelines, and also that provisions of the regulations relevant to the use of estriol were still in effect, preventing the FDA from taking action against pharmacies that use estriol in compounded products.

Wiley Protocol

Main article: Wiley Protocol

The Wiley Protocol is a version of compounded BHRT endorsed by T. S. Wiley whose goal is to produce serum levels of estradiol and progesterone that are identical to those of a young woman with a normal a menstrual cycle. The Wiley Protocol has been criticized by others for a variety of reasons.

Footnotes

^ a b c The Board of Trustees of The North American Menopause Society (2008). “Position statement – Estrogen and progestogen use in postmenopausal women: July 2008 position statement of The North American Menopause Society”. Menopause: the Journal of the North American Menopause Society 15 (4): 584603. doi:10.1097/gme.0b013e31817b076a. PMID 18580541. PMC 2756246. http://www.menopause.org/PSHT08.pdf. 

^ a b c d e f Boothby, LA; Doering PL; Kipersztok S (2004). “Bioidentical hormone therapy: a review”. Menopause: the Journal of the North American Menopause Society 11 (3): 35667. doi:10.1097/01.GME.0000094356.92081.EF. PMID 15167316. 

^ Adams C, Cannell S (2001). “Women’s beliefs about “natural” hormones and natural hormone replacement therapy”. Menopause 8 (6): 43340. PMID 11723417. 

^ a b c d e f g h i j k l “What are bioidentical hormones?”. Harvard Women’s Health Watch (Harvard Medical School). 2006-08-01. https://www.health.harvard.edu/newsweek/What-are-bioidentical-hormones.htm. Retrieved 2009-02-27. 

^ a b c d e “FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs”. FDA. 2008-01-09. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116832.htm. Retrieved 2009-02-17. 

^ a b c d e f g h i j k l m n o p q r s t u v w x y z Cirigliano, M (2007). “Bioidentical hormone therapy: a review of the evidence” (pdf). Journal of Womens Health 16 (5): 60031. doi:10.1089/jwh.2006.0311. PMID 17627398. http://www.solaltech.com/doctors/3/Bioidentical Hormone Therapy– Cirigliano.pdf. 

^ a b c d e f g h i j k l m n o p q r s t u v w x y z aa ab ac ad Boothby LA, Doering PL (August 2008). “Bioidentical hormone therapy: a panacea that lacks supportive evidence”. Curr. Opin. Obstet. Gynecol. 20 (4): 4007. doi:10.1097/GCO.0b013e3283081ae9. PMID 18660693. 

^ a b c d e f g h i j k l Fugh-Berman, A; Bythrow J (2007). “Bioidentical hormones for menopausal hormone therapy: variation on a theme”. Journal of General Internal Medicine 22 (7): 10304. doi:10.1007/s11606-007-0141-4. PMID 17549577. 

^ a b c d “The Endocrine Society- Position Statement: Bioidentical Hormones” (pdf). The Endocrine Society. 2006-10-01. http://www.endo-society.org/advocacy/policy/upload/BH_Position_Statement_final_10_25_06_w_Header.pdf. Retrieved 2009-02-29. 

^ a b c d e “ACOG News Release: ACOG Reiterates Stance on So-Called “Bioidentical” Hormones”. American College of Obstetricians and Gynecologists. 2009-02-03. http://www.acog.org/from_home/publications/press_releases/nr02-03-09.cfm. Retrieved 2009-09-18. 

^ a b “Bioidentical hormone replacement: Safety requires oversight”. American Medical Association. 2006-12-11. http://www.ama-assn.org/amednews/2006/12/11/edsa1211.htm. Retrieved 2010-01-08. 

^ a b c “American Medical Association Women Physicians Congress: Policy Compendium”. American Medical Association. 2007-10-01. http://www.ama-assn.org/ama1/pub/upload/mm/19/wpccompendfinal.pdf. Retrieved 2010-01-06. 

^ a b “Breast Cancer: Early Detection – The importance of finding breast cancer early”. American Cancer Society. 2009-09-22. http://www.cancer.org/docroot/CRI/content/CRI_2_6x_Breast_Cancer_Early_Detection.asp?sitearea=. Retrieved 2010-01-18. 

^ Pines A, Sturdee DW, Birkhuser MH, Schneider HP, Gambacciani M, Panay N (June 2007). “IMS updated recommendations on postmenopausal hormone therapy” (pdf). Climacteric 10 (3): 18194. doi:10.1080/13697130701361657. PMID 17487645. http://www.imsociety.org/pdf_files/ims_recommendations/ims_updated_recommendations_on_postmenopausal_hormone_therapy_27_02_07.pdf. 

^ a b c d e f g h Chervenak J (October 2009). “Bioidentical hormones for maturing women”. Maturitas 64 (2): 869. doi:10.1016/j.maturitas.2009.08.002. PMID 19766414. 

^ ACOG Committee on Gynecologic Practice (November 2005). “ACOG Committee Opinion #322: Compounded bioidentical hormones” (pdf). Obstet Gynecol 106 (5 Pt 1): 113940. PMID 16260546. http://catawbawomenscenter.com/MenopauseACOGHandout.pdf. 

^ Noble RL (April 1966). “J. B. Collip, 1893-1965″ (pdf). J. Reprod. Fertil. 11 (2): 16770. PMID 5328022. http://www.reproduction-online.org/cgi/reprint/11/2/167.pdf. {

^ Vance, DA (2007). “Premarin: The Intriguing Hisotry of a Controversial Drug” (pdf). International Journal of Pharmaceutical Compounding 11 (4): 282287. http://www.solaltech.com/doctors/3/HOT OFF THE PRESS Premarin-The_Intriguing_History_of_a_Controversial_Drug.pdf. 

^ a b c d e f g h Schwartz, E; Holtorf K (2008). “Hormones in Wellness and Disease Prevention: Common Practices, Current State of the Evidence, and Questions for the Future” (pdf). Prim Care Clin Office Pract 35 (4): 669705. doi:10.1016/j.pop.2008.07.015. PMID 18928825. http://www.hormoneandlongevitycenter.com/nss-folder/pictures/Holtorf-Med-Clinics.pdf. 

^ McCullough, M (1998-09-03). “Hormone Options”. Chicago Tribune: pp. 7. http://pqasb.pqarchiver.com/chicagotribune/access/33644485.html?dids=33644485:33644485&FMT=ABS&FMTS=ABS:FT&type=current&date=Sep+03,+1998&author=Marie+McCullough,+Philadelphia+Inquirer.&pub=Chicago+Tribune&desc=HORMONE+OPTIONS&pqatl=google. Retrieved 2009-12-16. 

^ a b c d e f g h i j Rosenthal MS (2008). “Ethical problems with bioidentical hormone therapy”. Int. J. Impot. Res. 20 (1): 4552. doi:10.1038/sj.ijir.3901622. PMID 18075509. 

^ a b Watt PJ, Hughes RB, Rettew LB, Adams R (2003). “A holistic programmatic approach to natural hormone replacement”. Fam Community Health 26 (1): 5363. PMID 12802128. 

^ a b c “Bio-Identicals: Sorting Myth from Fact”. FDA. 2008-04-08. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm. Retrieved 2009-12-01. 

^ a b c d e f g “Compounded Menopausal Hormone Therapy Questions and Answers”. FDA. 2009-09-23. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm183088.htm. Retrieved 2009-12-01. 

^ a b c Kalvaitis, K (2008). “Compounded hormone therapies: unproven, untested – and popular” (web reprint). Endocrine Today 6 (5). http://www.endocrinetoday.com/view.aspx?rid=27231. 

^ a b McBane, SE (2008). “Easing vasomotor symptoms: Besides HRT, what works?”. Journal of the American Academy of Physicians Assistants 21 (4): 2631. PMID 18468366. 

^ a b Rosenthal, MS (2008). “The Wiley Protocol: an analysis of ethical issues”. Menopause 15 (5): 101422. doi:10.1097/gme.0b013e318178862e. PMID 18551081. 

^ a b “Understanding the Controversy: Hormone Testing and Bioidentical Hormones” (pdf). 2006-10-11. http://www.menopause.org/edumaterials/PG06monograph.pdf. Retrieved 2010-01-18. 

^ a b c Sites CK (March 2008). “Bioidentical hormones for menopausal therapy”. Womens Health (Lond Engl) 4 (2): 16371. doi:10.2217/17455057.4.2.163. PMID 19072518. http://www.medscape.com/viewarticle/571299.  (free subscription required)

^ a b c d Barr Laboratories, Inc. (March 2008). “ESTRACE TABLETS, (estradiol tablets, USP)” (PDF). wcrx.com. http://www.wcrx.com/pdfs/pi/pi_estrace_wc_imprint.pdf. Retrieved 27 January 2010. 

^ a b c Gallenberg, M (2007-08-21). “Bioidentical hormones: Are they safer?”. Mayo Clinic. http://www.mayoclinic.com/health/bioidentical-hormones/AN01133. Retrieved 2010-01-14. 

^ a b Pastner, B (2008). “Pharmacy Compounding of Bioidentical Hormone Replacement Therapy (BHRT): A Proposed New Approach to Justify FDA Regulation of These Prescription Drugs”. Food & Drug L.J. 63 (2): 45991. PMID 18561473. 

^ “Bioidentical Hormone Therapy”. North American Menopause Society. 2009-10-11. http://www.menopause.org/bioidentical.aspx. Retrieved 2010-01-18. 

^ “Bioidentical hormone therapy”. Society of Obstetricians and Gynaecologists of Canada. http://www.menopauseandu.ca/therapies/bioidentical-hormone-therapy_e.aspx. Retrieved 2010-01-18. 

^ a b c d Holtorf K (January 2009). “The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy?” (pdf). Postgrad Med 121 (1): 7385. doi:10.3810/pgm.2009.01.1949. PMID 19179815. http://www.holtorfmed.com/nss-folder/pdf/BHRT-PGM-2009.pdf. 

^ a b Moskowitz, D (2006). “A comprehensive review of the safety and efficacy of bioidentical hormones for the management of menopause and related health risks”. Alternative Medicine Review 11 (3): 20823. PMID 17217322. http://www.thorne.com/altmedrev/.fulltext/11/3/208.pdf. 

^ Sites, CK (2008). “Bioidentical hormones for menopausal therapy”. Womens Health 4 (2): 16371. doi:10.2217/17455057.4.2.163. PMID 19072518. 

^ a b Ellin, A (2006-10-15). “A Battle Over ‘Juice of Youth’”. The New York Times. http://www.nytimes.com/2006/10/15/fashion/15suzanne.html?_r=1&pagewanted=all. Retrieved 2009-10-27. 

^ “The Bioidentical Debate”. The Oprah Winfrey Show. http://www.oprah.com/slideshow/oprahshow/20090128_tows_suzannesomers/. Retrieved 2009-12-01. 

^ a b c Burrell BA (September 2009). “The replacement of the replacement in menopause: hormone therapy, controversies, truth and risk”. Nurs Inq 16 (3): 21222. doi:10.1111/j.1440-1800.2009.00456.x. PMID 19689648. 

^ MacLennan AH, Sturdee DW (February 2006). “The ‘bioidentical/bioequivalent’ hormone scam”. Climacteric 9 (1): 13. doi:10.1080/13697130500487166. PMID 16428119. 

^ Writing Group for the Women’s Health Initiative Investigators (2002). “Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women’s Health Initiative Randomized Controlled Trial”. JAMA 288 (3): 321333. doi:10.1001/jama.288.3.321. PMID 12117397. http://jama.ama-assn.org/cgi/content/abstract/288/3/321. 

^ Chlebowski, RT; Kuller LH; Prentice RL; Stefanick ML; Manson JE; Gass M; et al. (2009). “Breast cancer after use of estrogen plus progestin in postmenopausal women”. NEJM 360 (6): 573. doi:10.1056/NEJMoa0807684. PMID 19196674. http://content.nejm.org/cgi/content/full/360/6/573. 

^ Davis, SR; Kruger J (2008-08-14). “2003 November 29 – Bioidentical hormones (troches) advice for doctors”. Australian Menopause Society. http://www.menopause.org.au/content/view/212/102/. Retrieved 2009-08-25. 

^ Davis, SR; Kruger J (2003-11-29). “2003 November 29 – Bioidentical hormones (troches) advice to consumers”. Australian Menopause Society. http://www.menopause.org.au/content/view/211/102/. Retrieved 2009-08-25. 

^ “Natural Hormone Pharmacy Offers Alternative Solution for Hormone Replacement” (Press Release). 2002-07-15. http://www.accessmylibrary.com/coms2/summary_0286-25648821_ITM. Retrieved 2009-12-07. 

^ “Bioidentical Estrogen & Progesterone”. Holtorf Medical Group. http://www.holtorfmed.com/topics/bioidentical-estrogen-progesterone. Retrieved 2009-12-11. 

^ O’Connor, A (2004-03-30). “Possible Peril Found in Menopause Cream”. The New York Times. http://www.nytimes.com/2004/03/30/health/possible-peril-found-in-menopause-cream.html?sec=health&&=Top/Reference/Times Topics/Subjects/W/Women. Retrieved 2009-12-11. 

^ “Statement of Steven K. Galson, M.D., M.P.H., Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration before Senate Special committee on Aging, “Bio-Identical Hormones: Sound Science or Bad Medicine”". FDA. 2007-04-19. http://www.fda.gov/ola/2007/hormone041907.html. Retrieved 2007-12-01. 

^ Romero, M (2002). “Bioidentical hormone replacement therapy. Customizing care for perimenopausal and menopausal women”. Adv Nurse Pract 10 (11): 478, 512. PMID 12478948. 

^ a b “Compounded Menopausal Hormone Therapy Questions and Answers”. FDA. 2009-09-23. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm183088.htm#FDAsResponsetoWyeths. Retrieved 2010-01-21. 

^ “The American Association of Clinical Endocrinologists (AACE) strongly supports the FDA in its concerns regarding the marketing and use of so called Bio-identical Hormones”. American Association of Clinical Endocrinologists. 2008-01-23. http://media.aace.com/article_display.cfm?article_id=4681. Retrieved 2010-01-18. 

^ “Senators Join Thousands of Patients, Doctors, Pharmacists in Supporting Women Access to Critical Hormone Treatments” (pdf). International Academy of Compounding Pharmacists. 2008-06-16. http://www.iacprx.org/site/DocServer/SCONRES_88_Press_Release_061608.pdf?docID=4461. Retrieved 2010-01-18. 

^ “Court rules compounded products are neither uniformly exempt from nor subject to new drug approval requirements”. American Pharmacists Association. 2008-07-31. http://www.pharmacist.com/AM/PrinterTemplate.cfm?Section=Pharmacy_News&template=/CM/ContentDisplay.cfm&ContentID=16948. Retrieved 2010-01-21. 

^ Sherr L; Ruppel G (2007-02-16). “Suzanne Somers: Super Saleswoman: Has Somers Found the Fountain of Youth?”. ABC News. http://www.abcnews.go.com/print?id=2874767. Retrieved 2007-12-01. 

^ Kantrowitz B; Wingert P (2006-11-13). “A Real Somers Storm: At war over Suzanne Somers’s book on ‘bioidenticals’”. Newsweek. http://www.newsweek.com/id/44568. Retrieved 2007-12-01. 

External links

Senate Hearings on Bioidentical Hormones: Sound Science or Bad Medicine? by the United States Senate Special Committee on Aging

Categories: Endocrinology | MenopauseHidden categories: NPOV disputes from November 2009 | All NPOV disputes | All articles with specifically-marked weasel-worded phrases | Articles with specifically-marked weasel-worded phrases from January 2010 | All articles with unsourced statements | Articles with unsourced statements from January 2010

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Promises Kept: The University of Mississippi Medical Center


$9.21


With very little money but with a groundswell of support from all sectors of the state, the two-year medical school at the University of Mississippi in Oxford became the University of Mississippi Medical Center in Jackson in 1955. Including more than fifty photographs, "Promises Kept" traces the development of the medical center from one school and two hospital wings to a major center for professional health education with four hospitals, five schools, a work force of more than 7,500 and a $650 million annual budget. In the 1960s, medical center leadership faced the challenge of maintaining stability in a rapidly changing social order and accomplishing the peaceful racial integration among both patients and employees. Though often strapped for cash and amid crises and conflicts, the small medical center in the nation’s poorest state stayed true to its mission. This history details the careers of medical center leaders who were dedicated to assuring that the institution never deviated from its focus on healing the sick, providing health professionals for Mississippi, and researching new ways of understanding and treating illness. The center nurtured the careers of two of the most important individuals in modern medicine, James D. Hardy and Arthur C. Guyton. In 1964 Hardy performed the world’s first heart transplant three years before Christiaan Barnard. In 1956, Guyton published his Textbook of Medical Physiology, which to this day remains the most widely used textbook in the field, and the standard physiology text around the world. Using archival records, photographs, and other documents, "Promises Kept: The University of Mississippi Medical Center" is an overview of one of the state’s most significant institutions. Janis Quinn of Florence, Mississippi, is a freelance writer whose work has been published in the "Journal of the Mississippi State Medical Association," "Journal of the Mississippi Dental Association," and "Jackson Magazine."

Campus Images KY998SG University of Kentucky Spirit Graduate Frame with Campus Image


Campus Images KY998SG University of Kentucky Spirit Graduate Frame with Campus Image


$295.73


Campus Images has long been the leading resource for artistic renderings of recognizable college and university campus landmarks. Our merchandise selection has expanded to offer home, apparel, auto and office accessories. We carefully choose our items with you in mind . . . The incoming freshman at Duke, the wife of an alumnus from Penn State, or the graduating senior at Berkeley. Whatever the occasion, a reminder of those four- or more- important years is always the perfect gift! Our selection has grown, but our goal is the same . . . to serve our customers. Please let us know if there is anyway that we can better serve you. Our Spirit Diploma Frame is a perfect way to show your school spirit.Classic satin mahogany spirit diploma frame with Campus Images lithograph. School logo in matting. School colors are used for matting. Custom made to fit any diploma size

Campus Images KY999SG Eastern Kentucky University Spirit Graduate Frame


Campus Images KY999SG Eastern Kentucky University Spirit Graduate Frame


$299.2


Campus Images has long been the leading resource for artistic renderings of recognizable college and university campus landmarks. Our merchandise selection has expanded to offer home, apparel, auto and office accessories. We carefully choose our items with you in mind . . . The incoming freshman at Duke, the wife of an alumnus from Penn State, or the graduating senior at Berkeley. Whatever the occasion, a reminder of those four- or more- important years is always the perfect gift! Our selection has grown, but our goal is the same . . . to serve our customers. Please let us know if there is anyway that we can better serve you. Our Spirit Diploma Frame is a perfect way to show your school spirit.Classic satin mahogany spirit diploma frame with Campus Images lithograph. School logo in matting. School colors are used for matting. Custom made to fit any diploma size

Chemistry and Medicine: Papers Presented at the Fiftieth Anniversary of the Founding of the Medical School of the University of Mi


Chemistry and Medicine: Papers Presented at the Fiftieth Anniversary of the Founding of the Medical School of the University of Mi


$4.53


"Chemistry and Medicine " was first published in 1940. Minnesota Archive Editions uses digital technology to make long-unavailable books once again accessible, and are published unaltered from the original University of Minnesota Press editions.

Not Just Any Medical School: The Science, Practice, and Teaching of Medicine at the University of Michigan, 1850-1941


Not Just Any Medical School: The Science, Practice, and Teaching of Medicine at the University of Michigan, 1850-1941


$3.95


"Not Just Any Medical School" details the establishment of the University of Michigan Medical School. It provides a picture of its students, curriculum, amphitheaters, laboratories, hospitals, and patients as seen through the eyes of its leading faculty members and documented by their published works, lecture notes, and other primary and secondary sources. The book begins with the selection of the first five professors and continues through the appointment of statesman and scientist Victor Vaughan as dean and his successors to 1941. Organized by specialty, the material is chronological within chapters. Illustrations include student and faculty scenes, hospital interiors and exteriors, and medical apparatus. The narrative includes numerous direct quotes from research papers, lectures, and letters illustrating that Michigan was "not just any medical school." Many of the significant medical and scientific advances that originated at Michigan are described in detail. Appearing in conjunction with the sesquicentennial of the Medical School, "Not Just Any Medical School" will appeal to those interested in the history of medicine and particularly to those with a connection to the University of Michigan. Horace Davenport is William Beaumont Professor Emeritus of Physiology, University of Michigan.

Team Golf 21955 University of Kentucky 50 Imprinted Tee Pack


Team Golf 21955 University of Kentucky 50 Imprinted Tee Pack


$24.18


Pack includes 50 regulation 2-3/4" multi-colored tees with school imprint. A perfect way to tee up your next ball.Theme: Golf.Team: University of Kentucky.League: PGA.

University of Kentucky Malibu


University of Kentucky Malibu


$89.66


Insulated pack with picnic service for 2 made of 600D polyester canvas. The elegant and unique Malibu shoulder pack is perfect for picnics, concerts, or travel. This tote has an integrated wine storage section and a spacious food storage section with removable liner. The adjustable shoulder strap makes it easy to carry. A wonderful gift idea! Includes: 2 Wine glasses (acrylic), 2 Napkins (cotton 14 x 14 in.), 1 Corkscrew (waiter style stainless steel), 1 Cutting board (wood 6 x 6 in.), 1 Cheese knife (stainless steel w/wood handle), 2 Plates (melamine 9 in.), 2 Ea. Knives forks & spoons (stainless steel), 2 Napkins (cotton 14 x 14 in.). Color: Navy. Decoration: Embroidery.

University of Kentucky Metro Basket


University of Kentucky Metro Basket


$39.66


Lightweight, insulated basket. Features waterproof interior and expandable drawstring top. Aluminum frame with polyester canvas.. Color: Sky Blue. Decoration: Digital Print.

University of Kentucky Shot Glass


University of Kentucky Shot Glass


$3.99


University of Kentucky Shot Glass – – 1101419733

University of Kentucky Golf Umbrella


University of Kentucky Golf Umbrella


$27.99


Take your team spirit to the golf course with the University of Kentucky Wildcats Golf Umbrella and show everyone on the green your team pride. This umbrella is a great gift that lets them show their loyalty to their favorite team.

University of Kentucky Fan Brands


University of Kentucky Fan Brands


$7.99


Turn grilling into a contact sport. Brand your favorite team’s logo on your meat, bread, or veggies. Place your Fan Brand on your grill, allow it to heat up to 500 F, apply some olive oil or non-stick spray, then place your food over the Fan Brand. Your team logo will be transferred to your food in a few minutes. Cook until desired doneness is achieved. Fan Brands by FANMATS â„¢ are made of high conductivity metal alloy. Also works indoors with a frying pan.

University of Kentucky Baseball Mat


University of Kentucky Baseball Mat


$19.99


Baseball-shaped area rugs by FANMATS. Made in U.S.A. 100% nylon carpet and non-skid recycled vinyl backing. Machine washable. Officially licensed. Chromojet printed in true team colors.

University of Kentucky Oniva Seat


University of Kentucky Oniva Seat


$43.1


Portable, recreational recliner with shoulder strap. Features several adjustable seat back positions. Made of polyester and features a steel frame for durability.. Color: Blue. Decoration: Digital Print.

Northern Kentucky  University Alumnus


Northern Kentucky University Alumnus


$141.7


Campus Images has long been the leading resource for artistic renderings of recognizable college and university campus landmarks. Our merchandise selection has expanded to offer home, apparel, auto and office accessories. We carefully choose our items with you in mind . . . The incoming freshman at Duke, the wife of an alumnus from Penn State, or the graduating senior at Berkeley. Whatever the occasion, a reminder of those four- or more- important years is always the perfect gift! Our selection has grown, but our goal is the same . . . to serve our customers. Please let us know if there is anyway that we can better serve you. The lithograph is framed in a Mahogany frame with Black edge and double matting. Lithograph is Officially licensed Campus Images Lithograph. Finished size is 18'' x 14''.

Eastern Kentucky University Alumnus


Eastern Kentucky University Alumnus


$141.7


Campus Images has long been the leading resource for artistic renderings of recognizable college and university campus landmarks. Our merchandise selection has expanded to offer home, apparel, auto and office accessories. We carefully choose our items with you in mind . . . The incoming freshman at Duke, the wife of an alumnus from Penn State, or the graduating senior at Berkeley. Whatever the occasion, a reminder of those four- or more- important years is always the perfect gift! Our selection has grown, but our goal is the same . . . to serve our customers. Please let us know if there is anyway that we can better serve you. The lithograph is framed in a Mahogany frame with Black edge and double matting. Lithograph is Officially licensed Campus Images Lithograph. Finished size is 18'' x 14''.

University of Kentucky Grill Mat


University of Kentucky Grill Mat


$24.99


Protect your deck or patio while displaying your favorite team! These 100% Vinyl Grill Mats are a universal fit to most grills, prevents spills from soaking in and staining, and cleans up easily with a garden hose.

University of Kentucky Basketball Mat


University of Kentucky Basketball Mat


$19.99


For all those hoops fans out there: basketball-shaped area rugs by FANMATS. Made in U.S.A. 100% nylon carpet and non-skid recycled vinyl backing. Machine washable. Officially licensed. Chromojet printed in true team colors.

University of Kentucky Circo


University of Kentucky Circo


$27.59


This swivel-style circular chopping board is made of naturally durable hardwood. The unique design holds four cheese tools inside and features a recessed moat along the board’s edge to catch cheese brine or other liquids. The Circo cheese board offer over 82 square inches of cutting surface! Perfect for any cheese connoisseur. Includes: 1 Hard cheese knife, 1 Cheese shaver, 1 Fork-tipped cheese knife, 1 Cheese spreader. Color: Natural. Decoration: Laser Engraving.

University of Kentucky Picnic Table


University of Kentucky Picnic Table


$100


Folding picnic table with four seats (maximum weight capacity of 250 lbs. per seat). Made with high strength aluminum alloy frame and ABS plastic. Store and carry it anywhere in its portable suitcase form.. Color: Royal Blue. Decoration: Digital Print.

University of Kentucky Blue Jacket


University of Kentucky Blue Jacket


$43.1


University of Kentucky Blue Jacket. Comfortable Sleek Jacket. Show off Your pride for the University of Kentucky! Size assortment is 9 Jackets of 4XL and 5 Jackets of 5XL. Polyester Material and Metal Zipper.

Kentucky University Beanie Mascot


Kentucky University Beanie Mascot


$8.62


Kentucky University Beanie Mascot. Show your pride for Kentucky University with this one-of-kind Beanie Mascot – The Wild Cat. 8 Inches Tall.

University of Kentucky Duet


University of Kentucky Duet


$39.66


Insulated wine and cheese tote with 2 compartments for wine, made of 600D polyester canvas. The elegant and unique Duet wine and cheese tote is perfect for picnics, concerts, or travel. This tote has two compartments for wine bottles and a storage section to carry the amenities included: hardwood cutting board, water style corkscrew, and cheese knife. The adjustable shoulder strap makes it easy to carry. Convenient and practical, the Duet is perfect for wine and cheese lovers. A wonderful gift idea! Includes: 1 Corkscrew (waiter style stainless steel), 1 Cutting board (wood 6 x 6 in.), 1 Cheese knife (stainless steel w/wood handle). Color: Navy. Decoration: Digital Print.

University of Kentucky Vulcan


University of Kentucky Vulcan


$206.9


The ultimate, all-in-one, insulated tailgating cooler with gas grill, three-piece BBQ tools, and fully-removable waterproof cooler section. Propane not included. Optional trolley sold separately. Includes: 1 Propane BBQ grill with lid (propane not included), 1 Large spatula with serrated edge, 1 Pair tongs, 1 BBQ fork, 1 Removable, insulated cooler tote. Color: Grey/Black. Decoration: Digital Print.

University of Kentucky Sports Chair


University of Kentucky Sports Chair


$86.21


The lightweight and durable folding aluminum Sports Chair is perfect for outdoor leisure. In addition to being lightweight, a removable shoulder strap makes this chair very easy to carry. The extra-wide seat (made from durable 600D polyester) and padded armrests were designed for optimum comfort. The large side flap has a velcro pocket for a cellular phone, a velcro pocket for sunglasses, a large zipper pocket to hold valuables, and an insulated wine/water bottle holder (protected by ThermoGuard). A convenient side table folds out to hold food, drinks, etc. The sports chair makes an excellent gift!. Color: Navy. Decoration: Digital Print.

University of Kentucky Zuma


University of Kentucky Zuma


$34.48


The unique and innovative Zuma Insulated Backpack is perfect for any outdoor activity. This insulated bag is divided into two sections: the top mesh section (with drawstring closure) is designed to hold clothing, towels, etc. The bottom section is an insulated cooler (featuring ThermoGuard) that keeps food hot or cold for hours. This cooler section has a heat-sealed waterproof lining to eliminate leaks. The Zuma Insulated Backpack also has one large zippered pocket which keeps your essentials/valuables at hand. Stylish, light-weight and functional, the Zuma is terrific for day trips, hiking, the beach, sporting events, and fishing. Makes an excellent gift item.. Color: Beige. Decoration: Digital Print.

University of Kentucky Shield Reflector


University of Kentucky Shield Reflector


$16.99


Show your team pride wherever you go with this shield reflector. Featuring University of Kentucky team colors and logo, this high-intensity reflector is perfect for cars, trucks, lockers, doors, and mailboxes.

University of Kentucky Nesting Tables


University of Kentucky Nesting Tables


$94


-Set of 3 nesting tables -Three sizes: 9″ x 20″, 10″ x 24″, 11 1/2″ x 27 1/2″ tall -Wrought iron -Stained glass mosaic top on mortar base -Stained glass mosaic


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