Winner of $5000 Boerhinger Mannheim Award - Real Results.
Tame Your HormonesTM- Heal Your Life
Benefits - Loss of vital hormones is common. Replacing these with exactly the same molecules that were lost, is the key to better health. Enjoy several benefits, including increased bone strength, less skin wrinkling and stronger hair and nails. Of course, hormone replacement will also endmenopause symptoms. Even younger women can significantly lessen PMS. We also know that over 60% of infertility is due to low progesterone levels. Progesterone cream can quickly and easily reverse this problem. And hormones are literally what give us life.They affect every aspect of our physical and mental health. They can even end depression, or "brain fog."
What We Solve - Bioidentical hormones have EXACTLY the same molecular structure as what your body produces. A large Swedish study found that natural hormones actually protect women from breast cancer and heart disease. And if you're currently taking Premarin or Prempro, you'll want to read our common sense report click. Award winning author, RN and Clinical Nurse Specialist, Corinne Peachment, and endocrine physician, Dr. Andrew Jones, MD, offer natural, bio-identical hormones. And see the best selling book on food and hormones (Amazon -Feed Your Need) along with CC7. Proof of Corinne Peachment's 27 years of hospital and clinic work here. And watch Dr. Andrew Jones videohere.
Does this Work? - Hundreds of well known people have publicly proclaimed the noticeable health benefits of bio-identical hormones. These include Dr. Christiane Northrup, Oprah Winfrey, Dr, Diana Schwarzbein, Robin McGraw, Dr. Uzzi Reiss, Dr. Mehmet Oz, Dr. John R. Lee and more. On January 15, 2009, Oprah Winfrey devoted her program to this topic. Emphasis was put on the benefits of bio-identical hormones vs synthetics, like Premarin and Prempro. We KNOW that these synthetics contribute to cancer, heart disease, strokes and dementia. It's no wonder, because Premarin is for horses, not for humans!
How does this Work? - Hormone balance provides measurable benefits to ALL aspects of anti-aging. It's not just about hot flashes and night sweats (although these will end). But if you watch our Australian TV news video, you'll understand why hormone balance affects osteoporosis, hair growth, skin wrinkling, insomnia and more. Look at it this way: when we become too old to reproduce, nature tries to get rid of us by causing a dramatic decline in hormone levels. Since nature's aim is to reproduce, once your hormones drop off, the signs of aging accelerate.
What's Unique About Corinne? As Harvard MD, Andrew Weil states, "Diabetes is the perfect model for understanding hormones." Corinne is a Diabetes Clinical Nurse Specialist and has written a book on hormones and food (Feed Your Need). She also worked at St. George Hospital, in Sydney Australia, and Wellesley Hospital, in Ontario, Canada (a University of Toronto affiliated teaching hospital). Her post graduate research on glycemic index and hormones earned Deans honors. She has worked in health education for 27 years. See visual evidence for credentials and awards, under "experience." Corinne now works with Dr. Andrew Jones of the Women's Health Institute of Texas. Dr. Jones video here.
Website content is designed to complement, not substitute, for medical care. None of our information will diagnose disease. If you have symptoms of illness, seek individual assessment from a qualified professional.
Copyright, 1994 - 2010, NewMax, LLC, Austin, Tx. 78705. All rights reserved. No part of this website may be copied or reproduced, without written consent from NewMax. "I have come, so that you might have life, and have it more abundantly." Jesus Christ
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Since the Women’s Health Initiative (WHI) results came out two years ago, millions of women have been scared off their hormone replacement therapy (HRT). Millions who have stayed on HRT feel insecure about it, and millions more women of menopausal years are suffering by going without replacement hormones, mostly for fear of getting breast cancer.
The WHI looked at the health effects of 27,000 women without a uterus using Premarin alone vs. placebo, and, in women with a uterus, Premarin + Provera vs. placebo. The trial was terminated early (after five years), when the study found that the Premarin + Provera group had more heart attacks, strokes, blood clots and breast cancer than the placebo group. The branch of the study that looked at Premarin alone vs. placebo showed an increased risk for stroke, but not for breast cancer.
In hard numbers, 10,000 postmenopausal women using Premarin + Provera for five years, compared to 10,000 non-treated postmenopausal women, will have six fewer cases of colorectal cancer, five fewer hip fractures, but eight more cases of breast cancer, eight more strokes, seven more heart attacks, and eighteen more blood clots. According to the study's authors, an individual woman's increased risk for breast cancer, with this hormone regimen, was less than one tenth of one percent a year.
The best outcome of the WHI, and one that the media has so far ignored, is that well-respected gyncologists are rethinking HRT. The Women’s Health Advisory Board, composed of some of the most respected gynecologists in this country, issued this statement, September 18, 2002, to doctors regarding the WHI study: “Hormone therapy, properly managed, remains a vital sustaining component in our efforts to enhance and extend the quality of life of women. The benefits outweigh the risks for almost all women. We are confident that the WHI findings, if objectively assessed and incorporated, have given physicians and their patients reasons to reconsider alternative and equally effective methods of post-menopausal hormone therapy.”
The numbers did not get reported like this two years ago. Since the WHI’s public premiere there has been time for further review and analysis of the study. Many respectable researchers have criticized the WHI study for flawed design methods. The media has been faulted for over-blowing the results and not presenting alternative interpretations and conclusions.
They go on to echo the same conclusions that integrative practitioners have advised for years: “CEE [Premarin] is not the estrogen produced by women during their menstrual life and may not be the most appropriate hormone to replenish a woman's body following menstrual life.”
Premarin, also known as conjugated equilin estrogen (CEE), is derived from pregnant mare’s urine. The estrogens in Premarin are perfect for a menopausal mare, but foreign to a human female. The same goes for Provera, aka, medroxy-progesterone acetate (MPA). This is a progestin, a progesterone-like substance that is also not native to the human female. It is these synthetic progesterones that are the biggest culprit in increasing breast cancer risk.
WHI results have turned the tide away from using non-bioidentical hormones such as Premarin and Provera, and towards the use of bioidentical hormones. Integrative medical practitioners who have been using only bio-identical HRT for years will no longer be a fringe minority. The WHI writing group concluded, “It remains possible that transdermal (cream absorbed through the skin) estradiol and progesterone, which most closely mimic the normal physiology and metabolism of endogenous sex hormones, may provide a different risk profile.”
The primary naturally occurring estrogens in human females are estradiol, estrone, and estriol. Estradiol is most prominent during a women's reproductive years, and the weaker estrone, is more prominent in postmenopausal women. Estriol is produced in large amounts when a woman is pregnant. Progesterone is the proper name to signify identical-to-natural progesterone; progestin signifies non-bioidentical progesterone. All of these forms of bioidentical hormones are available now, some from your compounding pharmacist and some from your mainstream pharmacists.
These hormones are termed “bio-identical” or “natural” when used in replacement therapy. “Bioidentical hormones” are synthesized in a laboratory from either yams or soy, but the final molecule is identical to those made within the human female. The term “synthetic” has been used for the non-native, non-bioidentical hormones such as Premarin, Provera, Estratest, etc..
Women need to remember that estrogens do not cause cancer. Certainly the evidence indicates that some estrogens (synthetics, like Premarin), at some levels, contribute to some breast cancer in some women. But if estradiol caused breast cancer, then one would expect most breast cancers to occur in women during their reproductive years, when estradiol levels are at the very highest. Instead, it is exactly the opposite: we see breast cancer occurring more often in women in the years when their estrogen levels have fallen dramatically.
A Swedish study involving 29,000 women conducted in the 1990's, reported that estradiol alone did not increase breast cancer risk. An eight year study is underway to examine the health effects of transdermal estradiol and progesterone (bioidentical hormones) on peri-menopausal women.
All the available evidence points to using bio-identical hormones over the now dethroned, non-bioidentical Premarin, Provera, and all their synthetic hormone cousins. Pharmaceutical companies only made Premarin and Provera so they'd have a patentable molecule. They cannot patent NATURAL hormones, so there's no financial gain in marketing and proving their effectiveness. (by Dr. Anne Welch MD, MHS)
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" I have come so that you might have life, and have it more abundantly." Jesus Christ
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Are bioidentical hormones safer and more effective than traditional hormone therapy? They sound like they would be because they're customized to the individual.
There's a lot of interest in bioidentical — or so-called "natural" — hormone therapy for menopause symptoms. However, there's no evidence that bioidentical hormones are safer or more effective than standard hormone replacement therapy.
Bioidentical hormones are custom-mixed formulas containing various hormones that are chemically identical to those naturally made by your body. These prescription and over-the-counter products are marketed as being tailored to a woman's individual hormone needs, typically determined through saliva hormone testing. Manufacturers claim that bioidentical hormones are safer than standard, FDA-approved hormone therapy.
According to the North American Menopause Society (NAMS), custom compounds may provide certain benefits, such as individualized doses and mixtures of products and forms that aren't available commercially. However, they may also pose risks to consumers. These compounds haven't been approved by the Food and Drug Administration (FDA) and as a result haven't been tested for purity, potency, efficacy or safety. These products may even contain unknown contaminants. For this reason, NAMS does not recommend these custom-mixed products over well-tested, government-approved commercial products for the majority of women.
Also, bioidentical estrogen and progesterone are available in FDA-approved hormone therapy products, including:
Estradiol, such as Estrace, Climara patch and Vivelle-Dot patch
Natural progesterone (Prometrium)
These products come in many different doses and forms. So, you don't need to turn to unregulated, individually compounded products as your only source of "natural" hormones.
by Jeffrey Dach MD
FDA Tries to Protect Wyeth From Financial Losses
Acting as agent for drug maker Wyeth this week, a dysfunctional and inept FDA fired the opening salvo in a misguided war on bio-identical hormones. Using typical Orwellian DoubleSpeak, the FDA issued a series of nonsensical and contradictory statements intended to serve the financial interests Wyeth, maker of synthetic hormones Premarin and Prempro, found to cause cancer and heart disease in the 2002 NIH sponsored Women’s Health Initiative Study. Since the study's release, millions of women have switched to the safe and more effective bio-identical hormones, currently prescribed by thousands of physicians, available as FDA approved products at local drug stores and compounding pharmacies. Wyeth has lost market share and suffered financial loss as synthetic hormone profits have declined from 4.4 to 1.2 billion annually from 2001 to 2006.
Wyeth Files a Citizen's Complaint with the FDA
October 2005, in a move to prevent further financial losses, Wyeth filed a Citizen's Complaint with the FDA, requesting the FDA take action against Wyeth’s competition, prohibiting compounding pharmacies from providing bio-identical hormones to their patients. More than 66,000 doctors, patients, and pharmacists filed comments in favor of bioidentical hormones and against Wyeth. In spite of this public outcry, Wyeth continues to abuse the FDA to the harm and detriment of millions of women who use bio-identical hormones.
Analysis of the FDA Statements:
Here is an analysis of the recent FDA statements: a comedy of errors, omissions, contradictions, and Orwellian DoubleSpeak. The January 9, 2008 statements can be found at the FDA website.
FDA Takes Action Against Compounded Menopause Hormone Therapy (1)(2)
Astonishingly, the FDA does not recognize the term, “bio-identical” !
The term “bio-identical” has no defined meaning in any medical or conventional dictionary, and FDA does not recognize the term. Even different medical groups define the term differently. The Endocrine Society, for example, defines “bio-identical” hormones as “compounds that have the exact same chemical and molecular structure as hormones that are produced in the human body,” while the American College of Obstetricians and Gynecologists (ACOG) defines “bio-identical” hormones as “plant-derived hormones that are biochemically similar or identical to those produced by the ovary or body.”
The term bioidentical has a definite meaning and is widely used. The term, bioidentical, means a hormone chemical structure which is identical to that found in the human body. Both the Endocrine Society and ACOG define the term, "bioIdentical", exactly the same, even though the two definitions are worded differently. It is an embarrassment to medical science that the word BioIdentical has to be used at all. All Hormones should have been manufactured as bio-identical hormones. However, because of U.S. patent law which prevents patenting a bioidentical hormone, the drug industry created chemically altered hormones which could be patented and sold at higher profit margins.
Astonishingly, the FDA is UNAWARE of a basic fact of biochemistry !
Astonishingly, the FDA is UNAWARE that identical chemical structures have the same biological effects. This is the basis for all biochemistry. A water molecule, for example, will have the same biologic effect in the body regardless of how it is synthesized, and this is also true for any other chemical, including hormones.
Many compounding pharmacies use Bio-identical as a marketing term to imply that drugs are natural, or have effects identical to those from hormones made by the body. FDA is not aware of credible scientific evidence to support these claims.
Bio-identical hormones are (1) natural and (2) have effects identical to hormones made in the body. These are basic axioms of biochemistry, and accepted as basic truth by all of biochemistry, including the following medical textbooks Lehninger Principles of Biochemistry, Guyton Textbook of Medical Physiology, and Williams Textbook of Endocrinology.
It is astonishing that the FDA can be UNAWARE of the scientific evidence that is present in every medical textbook, and thousands of Medline references that state that bio-identical hormones ARE natural and DO produce the same effects as human hormones !!
The FDA Does Recognize this basic fact of biochemistry when looking at Synthetic Hormone Structures !
Astonishingly, for the FDA, when it comes to synthetic hormones, all of a sudden, chemical structures that are identical DO have the same biologic effects !!
Compounded products that have identical chemical structures to synthetic hormones can be expected to have the same benefits—and risks— associated with FDA-approved hormone therapy.
This is Orwellian DoubleSpeak again. Compounded natural bio-identical hormones DO NOT have the same chemical structure as synthetic hormones. Compounded hormones are natural and bio-identical, and DO NOT increase risk of increased cancer and heart disease, as was demonstrated for the synthetic hormones in the WHI study. The Women’s Health Initiative study published in JAMA July 2002 showed that Provera, a chemically altered form of progesterone causes increased risk of cancer and heart disease, while the natural, human bioidentical progesterone does not. (5) (6)
The following two studies show that bio-identical hormones are safe: One is the French Cohort Study which showed that Bio-identical hormone therapy does not cause increased risk of breast cancer.(3) The second is the June 2007 NEJM Calcium Score study which showed no increase in heart disease risk with estrogen. (4)
The FDA Attacks Saliva Hormone Testing !
FDA says :
Some compounding pharmacies and other promoters of “BHRT” claim that estrogen levels in a person’s saliva can be tested by practitioners to help practitioners estimate the amount of hormone a person needs and purportedly to “customize” the hormone therapy for individual patients. There is no scientific basis for using saliva testing to adjust hormone levels. Instead, practitioners should adjust hormone therapy dosages based on a patient’s symptoms.
Salivary hormone testing has been done by two large companies for many years, Diagnos-Techs and ZRT. Both Web Sites list plenty of scientific evidence validating saliva hormone testing. ZRT lists references supporting salivary hormone testing here and here.
Here is a comment on Saliva Testing by Kenna Stephenson, MD, clinical professor at University of Texas at Tyler: "Saliva testing has been used in clinical research, including studies conducted at the National Institutes of Health (NIH) for more than 30 years. Saliva testing has been available to practicing physicians for over a decade, and Medicare and many insurance companies provide reimbursement for its use. Over years of clinical practice, I have found that saliva testing is the most accurate measurement of the body’s availability of the steroid hormones cortisol and DHEA and the sex steroid hormones estrogen, progesterone, and testosterone. Saliva testing correctly identifies the level of hormone at the cellular level (i.e. the biologically interactive form of the hormone), in contrast to a serum (blood) test, which measures the level of hormone circulating in the bloodstream."
In addition, salivary hormone testing for cortisol and melatonin is accepted and used by NASA on the astronauts on the space shuttle. (7)
A PubMed Medline search shows many research studies validating the use of salivary hormone testing.(8)
The FDA Claims Ignorance of Its Own FDA Approvals !
Some pharmacies promote hormone therapy for men in the form of testosterone to treat a decline in the level of testosterone in older men, sometimes referred to as andropause. There are currently no FDA-approved products for the treatment of andropause. In addition, there are no FDA-approved testosterone drugs for women.
Testosterone insufficiency in older men is associated with increased risk of death over the next 20 years. (17) Testosterone has been FDA approved for both men and women for decades. FDA approved testosterone commercial products can be obtained at the corner drugstore. Androgel for example, is FDA approved and contains testosterone. Estra-test is an FDA approved hormone for women which contains testosterone.
The following is a list of FDA-approved bio-identical hormone commercial products available at the drugstore commonly used to treat menopause and andropause:
Alora (estradiol): FDA approved 1996 - Watson Labs
Climara (estradiol): FDA approved 1994 - Bayer
FemPatch : FDA approved 1997 - Parke Davis
Vivelle-Dot (estradiol): FDA approved 1994 - Novartis
Estraderm: FDA approved 1986 - Novartis
Esclim: FDA approved 1998 - Women's First Healthcare
Estrace (estradiol): FDA approved 1993 -Bristol Myers Squibb
Estring: FDA approved 1996 - Pharmacia UpJohn
Prometrium (natural progesterone): FDA approved 1998 - Solvay
Androgel (natural testosterone): FDA approved 2000 - Unimed Pharmaceuticals
Crinone: FDA approved 1997 - Columbia Labs
FDA approved testosterone:Testoderm, Androderm, AndroGel
The FDA Tries to Ban Estriol !
Astonishingly, the FDA wants to ban estriol, a popular component of natural hormone therapy for women.
Some compounded “BHRT” drugs contain an estrogen component called estriol. No drug containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown. Pharmacies may not compound drugs containing estriol unless they have an FDA-sanctioned investigational new drug application.
Like many commonly prescribed drugs (e.g. quinine, Phenobarbital, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP). When Congress passed the FDA Modernization Act in 1997, it clearly indicated that drugs with a USP monograph could be compounded. 50,000 compounding pharmacists, 15,000 doctors and 2 million women have been prescribing, making and using estriol for decades. FDA approval is not required since this is regulated by the states, not the FDA.
Myth 1) Bioidentical hormone replacement therapy (BHRT) is unregulated.
Fact: Bioidentical hormones – like all compounded medications – are made from FDA- and USP-registered materials – the same used by pharmaceutical manufacturers – and their preparation is well regulated by state boards of pharmacy that have responsibility for overseeing all pharmacy practice in each state. Pharmacies that compound medications, including bioidentical hormones, are regulated by state pharmacy boards – similar to the relationship doctors have with state medical boards. In addition, there are also national standards and guidelines for compounded medications. The ingredients and their suppliers are regulated at the federal level by the FDA, with additional oversight provided by the U.S. Pharmacopeia.
Myth 2) Compounded bioidentical hormones are unsafe because they aren’t FDA-approved.
Fact: Compounded medications are regulated by state boards of pharmacy and are not subject to federal laws designed to regulate mass-produced drugs. This is because they are customized to meet the unique needs of patients based on the specific orders of a physician. The FDA approval process is designed for mass-produced manufactured drugs; it is universally recognized that holding compounded medications to these standards would completely eliminate their availability. Compounded medications are in a similar position as manufactured products prescribed for off-label use, which constitutes about a fifth of all prescriptions. They are not approved by the FDA for such use, and yet it is well accepted that physicians should be able to use their discretion to prescribe medications for off-label use.
Myth 3) Bioidentical hormones are just as risky as manufactured products like Premarin and Prempro.
Fact: There are no studies comparing the two types of therapies, so we cannot make any direct comparisons. The Women’s Health Initiative study examined only Premarin and Prempro, which do not use the same ingredients that are used to compound bioidentical hormones. To date there have been no studies that show a link between BHRT and cancer/strokes/heart attack, however the pharmacy community supports and funds studies to better determine the risk profile of BHRT.
A physician is trained and licensed to diagnose disease and to determine appropriate therapy for patients. A physician uses clinical expertise to determine appropriate therapies for patients. Premarin and Prempro may be appropriate for some patients. Bioidentical hormones may be appropriate for others. It is up to doctors to make that determination.
Myth 4) Pharmacists are recklessly promoting BHRT as safe and effective.
Fact: Compounded medicines are a lot like off-label prescriptions: they are not subject to FDA approval and, as a result, cannot be marketed as safe or effective. In fact, the FTC Act, 15 U.S.C. § 41 et seq., prohibits unfair or deceptive acts and practices, including false and unsubstantiated advertising claims. It is already illegal for a pharmacy to make claims without substantiation or to overstate the health benefits of the products they promote.
Myth 5) Bioidentical is a misleading term.
Fact: The chemical structures of bioidentical hormones are identical to those produced by the human body. Because the chemical structure is identical, these hormones are often referred to as bioidentical.
Sign a Petition and Join a Boycott
Don’t let the financial interests of the drug industry restrict your health freedom, call or email your senator today and voice your outrage at this blatant abuse of the FDA by special interest groups.
Write a protest letter your congressman with this easy link.
Sign this Petitionopposing the recent FDA actions against bioidentical hormones,
and send a message to Wyeth by boycotting their plist. Don't buy their products. Just say No to unethical manipulation of the FDA, or any government agency by drug companies.
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References and Links
List of medical textbooks stating that bio-identical hormones have the same chemical structure as those in the human body and have the same effect. (all of them):
Lehninger Principles of Biochemistry, Fourth Edition by David L. Nelson (Author), Michael M. Cox (Author)
Textbook of Medical Physiology by Arthur C. Guyton
Williams Textbook of Endocrinology
Basic & Clinical Endocrinology by Francis S. Greenspan
Review of Medical Physiology by Ganong, William F. MD
Endocrinology (5th Edition) by Mac E. Hadley
Endocrine Physiology by Susan Porterfield
(1) January 9, 2008 FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs
(2) Compounded Menopausal Hormone Therapy Questions and Answers
(3) Climacteric. 2002 Dec;5(4):332-40. Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women.de Lignières B, de Vathaire F, Fournier S, Urbinelli R, Allaert F, Le MG, Kuttenn F. Service d'Endocrinologie et Médecine de la Reproduction, Hôpital Necker, Paris, France.
The French Cohort Study showed that Bio-identical hormone therapy does not cause increased risk of breast cancer.
(4)NEJM Volume 356:2591-2602 June 21, 2007 Number 25 Estrogen Therapy and Coronary-Artery Calcification JoAnn E. Manson, M.D., The NEJM CAT Scan Calcium Score study showed no increase in heart disease risk with estrogen.
(5) Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women Principal Results From the Women's Health Initiative Randomized Controlled Trial Writing Group for the Women's Health Initiative Investigators JAMA. 2002;288:321-333.
(6) Effects of Conjugated Equine Estrogen in Postmenopausal Women With Hysterectomy The Women's Health Initiative Randomized Controlled Trial,The Women's Health Initiative Steering Committee,* JAMA. 2004;291:1701-1712.
(7) Assessment Of Sleep Dynamics In A Simulated Space Station Environment Lakshmi Putcha, Ph.D., Ram Nimmagudda, Ph.D., Chantal Rivera, Ph.D.
(8) Entrez pubmed, A simple medline search shows a research studies validating the use of salivary hormone testing.
(12) Irresponsible Journalism: BusinessWeek Regurgitates Wyeth’s Attacks on Pharmacy Compounding
(13) The Endocrine Society Position Statement Oct 2006 Bio-Identical Hormones
(14) The Endocrine Society Position Statement Oct 2006 Bio-Identical Hormones
(15) Bioidentical Hormones Lack Evidence for Safety and Effectiveness
(16) Low levels of testosterone may increase risk of death in older men Men's Health News Published: Tuesday, 16-Oct-2007, Journal of Clinical Endocrinology & Metabolism (JCEM).
(17) The Journal of Clinical Endocrinology & Metabolism Vol. 93, No. 1 68-75 Low Serum Testosterone and Mortality in Older Men, Gail A. Laughlin Testosterone insufficiency in older men is associated with increased risk of death over the following 20 yr, independent of multiple risk factors and several preexisting health conditions.
(18) DrErika Blasts Wyeth's War on Bioidentical Hormones, Erika Schwartz, MD, Patients' Health Advocate and Leading Expert on Bioidentical Hormones
(19) Wyeth's War on Women and Bioidenticals, Erika Schwartz, MD, Patients' Health Advocate and Leading Expert on Bioidentical Hormones.
(20) Bioidentical Hormones are not snake oil: They are available commercially at your local drugstore with a prescription from your regular MD . Erika Schwartz blog, web site. Erika Schwartz, MD, Patients' Health Advocate and Leading Expert on Bioidentical Hormones
(21) FDA says alternative hormone claims unsupported Wed Jan 9, Reuters news service
(22) Listing of references in the Scientific Literature on validating use of bio-identical hormones, Erika Schwartz, MD, Patients' Health Advocate and Leading Expert on Bioidentical Hormones
(23) Wednesday, Jan. 09, 2008 FDA Asserts New Policy to Restrict Women's Access to Bioidentical Hormones International Academy of Compounding Pharmacists
(24) FDA Asserts New Policy To Restrict Women's Access To Bioidentical Hormones,medicalnewstoday, 10 Jan 2008
(25) FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones Agency Warns Pharmacies Not to Compound Commonly Prescribed Hormone Treatments, Use the Term “Bio-identical” , IACPRX
(26) Tell Congress: Don't Take Away My Compounded Medications! Send a letter to your congressman.
(27) Hot Flash: FDA Warns About BHRT Drugs,January 9th, 2008 2:51 pm By Ed Silverman Pharmalot
(33) Pharmacies Warned About Compounding Estriol, Touting Mixture's Benefits Does the FDA have jurisdiction over these compounding pharmacies?There's a court battle going on right now to determine the answer to that question. Oral arguments are expected tomorrow in the U.S. 5th Circuit Court of Appeals in New Orleans. The fda is appealing a lower court ruling, which found that they do not have jurisdiction over drug preparations produced by compounding pharmacies.
(34) FDA Goes After 'Natural' HRT Claims Compounding Pharmacies Told to Stop Marketing 'Bio-identical Hormone Replacement Therapy'
(35) C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.
(36) Judge Issues Landmark Decision in Compounding Pharmacy Case Friday, May 26, 2006Midland, Texas, C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.
(37) Wyeth Pharmaceuticals tries to STOP your access to Bio-Identical Hormone Replacement Therapies (BHRT). BHRT-A BATTLE FOR THE TRUTH, C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.
(44) Salivary testosterone levels in preadolescent children, Daniela Ostatníková1
(45) Pathol Biol (Paris). 2001 Oct;49(8):660-7., Saliva assays in clinical and research biology.Lac G., Département génie biologique,
(46) Patterns of Salivary Estradiol and Progesterone across the Menstrual Cycle, BEATRICE K. GANDARA,a LINDA LERESCHE,a and LLOYD MANCLb
(47) FDA Approves Biex Test to Aid in Identifying Risk of Preterm Labor and Delivery. 5/5/1998 Biex, Inc. announced today the FDA granted marketing approval for the Company's salivary estriol test to help physicians identify risk for spontaneous preterm labor and delivery.
(49) WomenInBalance.org NonProfit Advocacy Group for BioIdentical Hormones. They have compiled the currently available science references behind the use of bioidentical hormones for women.
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What Is Hormone Testing? Menopausal hormone levels vary throughout the day, as well as from day to day. NAMS does not recommend hormone level testing.
2008 9-page transcript of a talk (with slides) by Bruce Patsner, MD, JD, entitled “Bioidentical Hormone Therapy: What’s the Harm?” There has been a clear lack of medical evidence supporting either the efficacy or safety claims of “individualized” prescription drugs.
FDA Takes Action “The pharmacy operations improperly claim that their drugs...are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.”