Grokking the new hormonal scene and the money trail: • A new “natural” hormone drug is in phase-3 trials. (Natural is commercial industry term for bio-identical). • It is the first “natural” hormone pharmaceutical—to be made by big Pharma rather than compounded by compounding pharmacies. • It is natural estradiol combined with progesterone. Oral. • It’s on the road to FDA approval. • This drug is called “Replenish”. • The REPLENISH Study and it’s published article in PubMed (NIH peer review site) was funded by TherapeuticsMD, Inc. • Many of the employees of TherapeuticsMD, Inc. were employees of the companies that used to make “synthetic” hormones, like Wyeth. • Pfizer purchased Prempro’s original manufacturer, Wyeth. (Prempro was the drug used in the ill-fate statistical fiasco, the Women’s Health Initiative, demonstrating that synthetic hormone replacement is dangerous) • A new Finnish article says that hormones need to be taken life long, not short term, to lower mortality timing by preventing heart attacks and strokes. • This study was presented at the conservative North American Menopause Society (NAMS) this October 2015. • Pfizer partially funded this session. • At the same exact time the FDA is trying to block compounding pharmacies from being able to legally fill bio-identical hormone scripts (thus making an opening for these new commercial meds) saying they are too difficult, thus dangerous, to compound. (Not true, in fact, the opposite) What’s happening? A paradigm shift. Hormone replacement is now being re-framed not as causing breast cancer or stroke, but when given individually and sensibly, reducing these risks. It is entering another era of recognition as a reasonable critical technology as we age, to keep us living better longer. Dr. Howard Hodis, MD, from the atherosclerosis research unit at the University of Southern California at Los Angeles, is a physician/scientist who I have been following for decades. I wrote about his research in Safe Hormones, Smart Women. Dr. Hodis says, based on this new Finnish study (which I give you details below)— “These are irrefutably consistent data that say that hormones lower mortality — and the message is, you stop, you die.” Individualized hormone replacement gives the technology to safeguard your brain, heart and mortality as you age. But who will have the right to make the money when the masses start to use them? There is a tsunami of aging folks. We are the fastest growing group throughout the globe. Things are a changing. This new paradigm shifting study was presented October 2015 at NAMS. It also published simultaneously in two peer review journals: Journal of Clinical Endocrinology and Metabolism. For years the conservative group NAMs—which gives guidelines for gynecologists nationally—recommended that prescribed hormones be given at the lowest level for the shortest time. And only used to help women bridge the transition from pre to post menopause. Then, go off. As soon as possible. I have never agreed with this viewpoint. Many (not all) integrative doctors have seen clinically that hormone replacement (long term) keeps our bones, brains, gut, energy, life force, sex life, attractiveness, and sense-of-self and esteem alive and kicking. But NAMS has said no. Short-term only. Enter Finland. Finland lends itself to a study like this. It’s got socialized medicine. Menopausal women are given hormones by the government for free. National registries then meticulously track their health. The Helsinki University Central Hospital in Finland identified 332,202 women who had been on hormone therapy for about 6-1/2 years and then stopped (between the years of 1992 through 2009). The heath of these women after going off replacement was then followed for another 5-1/2 years. This was done through two Finnish registries: 1) the Medicine Reimbursement Register and 2) the Causes of Death Registry. The end points monitored were; who got heart attacks or strokes and who died. In the first year after stopping hormone therapy, the risk for “adverse” heart events like heart attack, stroke or death was significantly higher compared to a standardized population. After a year “off” hormone therapy, these risks went below the comparison group. The same trends occurred for stroke. The lead author, Tom Mikkola, MD, a doc from the Helsinki University Central Hospital, said, “In my view, we have to shift the whole attitude, first in gynecologists and general practitioners, and eventually in cardiologists.” There will be resistance, but when women “stay” on hormone replacement, it protects their hearts and longevity. Not to mention brains. The Utah Cache County study published in the Journal of the American Medical Association in 2002 (but forgotten as it came out that same summer as the Women’s Health Initiative) showed that hormones protect brains. It showed that long-term estrogen therapy (10 years or more) cut down the risk of Alzheimer’s by 50%. In other words, estrogen replacement protects brain shrinkage, aging and cognition more than anything else other than “youth”. But now the battle of big corporations versus small compounding pharmacies, and also where, how and who we get hormone replacement from…. is on. For example, Replenish does not contain the protective, forgotten estrogen—estriol—that most integrative practitioners feel is a must to be added to estradiol. And long-term oral estrogen is not safe, versus other ways of getting it into your body. Lots of devils in the details. Everyone wants your business, your money and control over your hormones. Be informed to stay empowered. • Safe Hormones, Smart Women • DrLindseyBerkson.com
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Medical Disclaimer: The information contained in this website is not intended to replace a one-on-one relationship with a qualified health care professional and is not intended as medical advice. It is intended as a sharing of knowledge and information from the research and experience of Dr. Lindsey Berkson and the experts who have contributed to the field of research. You are encouraged to make your own health care decisions based upon your research and in partnership with a qualified health care professional of your choosing.