"The SVU Health Initiative for Women in Menopause"
There are 41 million women experiencing menopause in the US right now. All of you deserve to know what you are taking and determine if it is safe. Many, many ingredients used in finished formulas are not. Our idea is to create ground rules and a code of performance for ingredients within the Menopausal category. Safe, Natural, and with
"Proof of Performance"
A Bit of History:
The Menopause Category turned into complete chaos when the National Institute of Health came out with the Hormone Replacement Therapy Study in 2002 known as WHI. Not suggesting, but proving that a significant percentage of the 16,000 women evaluated were at risk with various grave health issues due the continued intake of synthetic, pharmaceutical grade hormones. This was known as Hormone Replacement Therapy or HRT’s.
This NIH study led to a great deal of fear and uncertainty as to viable choices to replace HRT's. This of course developed back when the Nutritional Industry held looser guidelines as to what was safe, and who could prove so. Thus, all forms of different ingredients were launched into the market with claims of performance but with no real notion of impartial evidence via human clinical evaluations. The market was a feeding frenzy towards supposed natural replacements that would generate revenue for the person or company that could get their product and claims to market first.
Within 2 years after the NIH study the market started to settle down because women know what works and what doesn't. Very clear symptoms that are either diminish or hopefully disappear. Word got out, companies jumped aboard and there was some form of logic towards botanical choices that would help. Unfortunately, the help in general, would manage maybe one symptom, part of the time.
Eventually and within a few years new concerns developed with end user manufacturers being savvy enough to ask questions like:
· Does the ingredient lead to cancer and can the supplier of the ingredients prove it does not?
· Does the ingredient maintain safety and toxicity standards over more than a few days or weeks of evaluation?
· Does the ingredient bear the risk of Liver toxicity?
· Does the ingredient work and perform in published studies by
reputable institutions that do not have a commercial interest in the outcome?
· Does the ingredient work on more than one symptom and can this be proven in a human clinical format?
· Will these supposed natural, and botanical ingredients meet the new, highly anticipated standards of FTC/ FDA guidelines which suggests at least 2 human clinical studies that demonstrate proof of performance?
Proactive and Empowerment: The SVU Initiative intends to be proactive and create guidelines for ingredient suppliers of these botanical, natural or nutra type ingredients for the Menopause category. Maybe others will follow, or not. Maybe others will follow within other market categories, or not. We are determined to launch the "SVU Initiative" or Safety vs. Uncertainty for women. We intend to provide women with ways to “link” to various published studies or summaries concerning the benefits and the risks when consuming these alternative, botanical, natural, or nutra Menopause Ingredients in the form of a pill or liquid. SVU spells out a specific code and commitment to guidelines that accommodate the evolving standards as inserted in FTC/ FDA actions over the past several months. Specifically,for the Women's Category for Menopause. We believe many women do not fully understand what they are buying when shopping for Menopause product choices. The SVU Initiative is for women to fully receive awareness and information as to the adverse studies that are put into the public domain concerning the review and study of Menopausal ingredients. We are not fully clear why this is the case but we will start at the grass roots level.
The SVU Menopause Science Code for Sellers of These Nutritional Type Ingredients:
1) Our Menopause Active Ingredients will maintain at least two human clinical studies to prove safety, efficacy, and performance.
2) Each clinical will be conducted in a group with at least 40 women
3) The Active Ingredient seller will conduct a Binding Affinity study to
show there is no binding on either the alpha or beta receptor sights which will then show no risk of cancer for women taking the ingredient.
4) The supplier will be able to demonstrate a full Liver Toxicity evaluation to prove the active ingredient is non-hepatotoxic which translates to safe for the liver vs. toxic.
5) The supplier will conduct MCF-7 studies to show no link of the Menopausal active ingredient to breast cancer cells.
6) Finally- the Ingredient supplier to the Menopausal Category will show their active component of the formula will pass a 4 week and a 13 week Toxicity Study evaluation as well as Genetic Toxicology tests.
Summary: We only hope this commitment from will set a standard that might reach all women who battle the very real symptoms of Menopause on a daily basis. Records show there are 41 million women in the USA experiencing Menopause in 2010. Every single woman deserves the right to understand what she is taking, what the risks are and maintain the personal knowledge that Safety comes first so there is no Uncertainty. If an ingredient was reporting that it failed binding affinity or that it might cause liver damage then let's see these warning(s) on the bottle of the finished product. Women deserve this inherent right to know and hopefully our links will generate knowledge, information and the empowerment to choose the right ingredients for treating Menopause.
Published Studies to be aware of:
1) The National Institute of Health study was conducted in 2001-2002 where 15,000 women were evaluated over 12 months comparing Hormone Replacement Therapy against a Placebo. The results showed risks of cancer and this was validated with a test method called Binding Affinity. The female receptor sites Alpha and Beta were shown to have positive interface with both site receptors.
2) The National Institute of Health study was conducted in 2007 where lab rats were evaluated after consuming Genistein which is the active component in most Soybean Isoflavone Extracts, There was Binding Affinity in the Beta receptor site. Again, not a positive indication of safety according to most experts. Thank goodness this study was not conducted on women.
3) British Journal of Cancer, 2009, 101, 160-165; “Serum Oestrogen Receptor ER-alpha and ER-beta Bioactivity are Independently Associated with Breast Cancer: A Proof of Principal Study