We need to let the FDA know that we’re watching. Action Alert!
**UPDATE- Due to the overwhelming response of our members, the webinar is SOLD OUT. Thank you for making this grassroots effort a success! We will post an update of the committee’s findings in our next newsletter for all those unable to attend.**– posted 6/26/2020
On July 1, the National Academy of Sciences, Engineering, and Medicine (NASEM) is holding a webinar to release their report on the “clinical utility” of compounded bioidentical hormone replacement therapy. We expect the FDA will use this report as ammunition to ban estriol and other bioidentical hormones from pharmacy compounding. It is critical that consumers attend this webinar to let the FDA know that we’re watching them.
As you’ll recall, estriol and other bioidentical hormones have been nominated to the FDA’s Demonstrably Difficult to Compound List; items that appear on the list when it is final will no longer be able to be made at compounding pharmacies. The FDA convened a NASEM committee to study the clinical utility of treating patients with compounded bioidentical hormones; the findings of this committee will be used by the FDA to make a final decision on the fate of estriol and other compounded hormones.
NASEM has conducted several public meetings to date on compounded bioidentical hormones. During these meetings, the FDA invited experts to present to the NASEM panel, and to us it seemed that the FDA stacked the deck against compounded bioidenticals. ANH and others had to fight to get bioidentical experts longer than five minutes to present their case. What’s also clear is that the NASEM committee members lack a fundamental understanding of how compounded BHRT is used to treat menopause, meaning that committee members are susceptible to the FDA’s bias.
A bad NASEM report would be disastrous, as the FDA will have all they need to conclude that compounded bioidentical hormones can be banned. We cannot let this happen. Estriol is particularly threatened, as there is no FDA-approved version of this critical hormone; if a ban goes through, estriol access will disappear.
Patient health and safety is at stake. A review of the clinical literature concluded that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more effective than synthetic or animal-derived hormones. On the other hand, studies have consistently demonstrated that synthetic hormones are associated with an increased risk of breast cancer. Synthetic and animal-derived hormones have also been shown to produce negative cardiovascular effects and to negate the cardio-protective effects of estrogen.
ANH-USA is working with the natural health community to get as many concerned citizens registered for this webinar as possible to demonstrate to the FDA that we’re watching them and that this issue is critical to the health of millions of women across the United States. Left to its own, the FDA will surely finish what they started in 2008, when the agency first went after estriol. We beat them back then, and we can do so again, but only with your help. Go here to register for this (free) webinar. (Note that it asks for your organization, but you are not required to list one to join and can leave this space blank.)
More background and coverage of this issue can be found on our campaign page here.
Action Alert! Sign our petition to reform our healthcare system that bars or undermines natural options like estriol. Please send your message immediately.
38 comments
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I tried to register for the webinar two times and the Register button was grayed out and would not let me register.
Hi Diane,
Thank you so much for your support!
We are very happy to say that all the available webinar spots have been filled, with many of them taken by our members. For those who weren’t able to get a spot ANH is going to provide a summary of the report release and any key points from the NASEM committee’s findings, which will be posted after the webinar.
I am a patient whose life and lifestyle will be seriously impacted by changes in bioidentical hormones. If you take these essential medicines from women, you will have blood and serious harm to many women on your hands. I am a medical librarian and read medicine and the changes contemplated are not evidence-based in any serious way. There is a great deal of poor and manipulated science about. The side effects of drugs for incontinence and osteoporosis and a good many conditions are bad compared to risks especially if women have adequate vitamin d and k. The costs for vulnerable older women on some drugs is prohibitive. And young women with endocrine problems are at risk too. There is a tremendous benefit in health and energy w bioidenticals for many and for families and the nation! There is a Creator watching and I pray you do not let mammon buy your soul.
Please keep estriol! It is a very necessary and safe drug!
I would be lost without my compounded meds. They balance so much in my system. My bi-est prescription not only helps my body but helps my mind as was evident to myself and my husband last year when I had to switch pharmacies and be without my bio-identicals for several weeks.
I have no side effects and I plan to take them as long as necessary for my health. In truth, I have had more worries about my blood pressure meds that come from China. I prefer to work with my doctor to find the best course for my health. Please allow us to choose what meds we are comfortable with and make them available.
Please do not take our compounded HRT hormones away. Estriol is one very important one.
Bioidentical hormones are essential for aging women, and are used for many medical necessities. They must remain legal and readily available. Thank you for this alert.
I watched my Parents disintegrate from pharmaceuticals and one of them very nearly killed me. Tens of thousands can be injured or killed by pharmaceuticals. You never hear of that, but if a few have an adverse reaction from a natural remedy, the FDA goes APESHIT! Big corporations are violently allergic to competition. I’m all for disestablishing the FDA and just have them regulate pharmaceuticals and keep the hell away from food. We already have the USDA to foul up that aspect. I can assure you, this broken down, old Vietnam era Veteran doesn’t trust this regime any farther than he can loft the Washington Monument. DC doesn’t stand for District of Columbia as much as it does Definitely Corrupted. While there may be a lot of good people in the FDA, its mission is going the way of the dodo.
Stop taking our RIGHTS AWAY
and
Stop the BUY OUTS just to give the highest payer so only there products are used!!!!!!!
Patient health and safety is at stake. A review of the clinical literature concluded that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more effective than synthetic or animal-derived hormones. On the other hand, studies have consistently demonstrated that synthetic hormones are associated with an increased risk of breast cancer. Synthetic and animal-derived hormones have also been shown to produce negative cardiovascular effects and to negate the cardio-protective effects of estrogen.
It is our right to do with our bodies whatever makes us feel good. Women (and men) need bio identical hormone replacement.
This push to prevent women from accessing natural hormones needs to be widely publicized, so that the public can be made aware of how these agencies’drive to force women to use hormones from Big Pharma that will damage their health.
Had I not discovered bioidentical hormones, I would be in a nursing home today. For too long I suffered from the effects of menopause, including panic attacks and severe brain fog. Working was becoming increasingly difficult, just trying to think or remember was becoming impossible. It began for me at 50, and I am now 72, and sharper & healthier than ever. I am sad to say that our government system, in cahoots with Big Pharma wants to keep us sick and on debilitating drugs for their own enrichment. WE CANNOT LET THEM DO IT!
Leave our hormones alone. Women need these to keep their sanity and the fda could care less.
Do not take away my right to choose Estriol over more harmful pharmaceuticals. Protect my rights and my health.
It will be nice if the FDA take sides with the natural and good products instead of being in business with the pharma crap
Please do Not ban estriol & other bioidentical hormones from Compounding pharmacies.
Estriol is a native compound gentle and balancing in the appropriate women. Banning it is a betrayal to Americans
That the FDA enabled the opioid crisis in the US to kill so many citizens and now believes they can competently intervene on behalf of hormone safety is a sad joke of politics and profits again attempting to override science and health outcomes.
Bring It On!
As will we.
The FDA needs to stay out of people’s individual personal decisions and choices surrounding their use of bio-identical hormones (vs. synthetic hormones). If anything, the FDA should be looking at whether synthetic hormones are more dangerous to health than bio-identical, given that the human body would have no way of naturally processing synthetic hormones. Let the doctors and patients decide if bio-identical hormones are correct for individuals, and since these are safely compounded, continue to allow compounding pharmacies to do their business. This is crazy that the FDA is worried about this. Why isn’t the FDA instead looking at the harm of ubiquitous chemicals like glyphosate in our food?
I was poisoned by LEVAQUIN and CIPRO (they are Fluoroquinolones) what they don’t list as a side effect is how it wipes out male and female testosterone…and destroys the endocrine system I became so weak and unable to walk. I have been diagnosed with so many things. One I began the natural hormone therapy after 10 yrs of suffering I got MY LIFE BACK. It was truly a blessing and I was not able to get any help from the traditional system that continues to harm and maim people and the FDA is nothing but an agency Fostering Drug Addictions.
I’ve been in practice since 1982, and rely on compounded estriol and progesterone for different reasons: Estriol, the least carcingenic and gentlest of the three estrogens (estradiol, estrone and estriol) is not currently available through conventional channels…and bio identical progesterone is only currently available in a non dividable gel cap. For many women in my practice, this is an excessive dose, and attended by adverse an unintended consequences.
To remove either or both of these from prescriber, and thus, patient access would constitute a harm to healthcare of women for whom they are indicated.
Compounded hormone replacement therapy is much healthier than the synthetic hormones. The FDA shouldn’t be involved in this at all. The only reason the FDA would disapprove these creams is to please the big pharmacies. That is totally unacceptable.
WHY would a safe and effective compound, bioidentical estriol, be replaced by a synthetic or animal derived hormone that causes increased risk of cardiovascular events and breast cancer? Banning this hormone will compromise the health and wellbeing of women as they age. Please maintain the availability of this compounded bioidentical hormone for women.
As a 55 year old woman in Menopause- I would Beg you not to remove estriol access from the market place for our use during this time in life. When used with bio- identical progesterone- it is the only thing to STOP my hot flashes! My mom, at 84, was taken off synthetic hormones at 74 and still has hot flashes!!! I don’t want to be in her shoes at that age when I can stop them with something as a healthy alternative.
Thank you for your time and attention to this important matter to women every where suffering from menopausal symptoms.
Jill Taylor
Please do not take our hormones. They have improved the quality of my life.
I tried to register for the event on July 1 but found registration had closed. I hope this means your efforts caused their meeting to be flooded with your members. Keep up the good work!
Hi Rick,
Thank you so much for your support!
You are correct! Thanks to everyone’s efforts we filled up all the available spots for the webinar. For those who weren’t able to get a spot we will release a detailed summary of the NASEM committee’s findings after the presentation.
I rely on HRT from plant based estriol.
Bio identicals have been a lifeline for me for the past 20 years. I had severe endometriosis which was reversed by bio identical progesterone. Now that I am in menopause my unbearable symptoms of hot flashes, fatigue and general malaise have been helped tremendously by bio identical estriol. My quality of life would be highly compromised without bio identicals. This is women’s health yet again being taken over by big pharma and men. Please let us have the freedom to make our own choices about our bodies!
. Studies have consistently shown that synthetic hormones have been
linked to an increase in breast cancer. Please don’t take away BHT.
Banning drugs because they don’t meet current profit goals is stupid, inhumane, and conspiratorial. The FDA’s conflicts of interest should be condemned and dealt with severely by Congress.
How can the awful, corrupt, bought and paid for by big pharma FDA be disbanded? All they do is shoot dogs, concern themselves with things that aren’t broken and try to hurt and diminish Americans that are bright enough to take care of themselves without pharmicopea help. Why are they allowed to go on and on?
I am a 73 year old woman who during menopause was unable to tolerate standard ERT which gave me heart palpitations. A compounded formula of 80% estriol plus 20% estradiol has served me very well with no side effects for the last 23 years. I certainly do not wish to loose my right to use this important part if my health regime. No one has the right to deny us this right. Who could possibly gain from this travesty? Oh yea . . them. We the people and God are watching.
Biodentical hormones are important – free choice
It is very discouraging to me that, after many years of trial and error with conventional HRT and feeling out of sorts, I finally have a protocol which makes me feel balanced and happy and now I am learning it may all go away. My doctor has tested me and found the right amounts of the hormones my body needs and then prescribed compounded products which are made without toxic chemicals. (I had tried Estrace at one point and did not fare well; then discovered it is made with parabens among other not so healthy ingredients.). I am one of those so-called canaries who are sensitive to many environmental chemicals and electromagnetic fields, so finding products that work well and do not leave me frazzled is no mean feat.
Please consider allowing compounding pharmacies to continue their good work on behalf of those of us who need them desperately.
Thank you!
It would be so refreshing to see leaders in our country who would support Integrative/Functional medicine viewpoints! How wonderful if they would take a stand against the decisions in our governmental agencies (FDA for one!), when their decisions are made purely for profit, rather than truly reaching the root cause of citizens’ illnesses and trying to actually heal them. The system (Big Pharma is a huge part of the problem) is wrong in so many ways, primarily morally!!!
I do not want to lose the opportunity to receive this for my health. After all, for me it is very important. I am no longer 20 years old and menopause makes me go crazy. I work with several psychologists in order to improve my well-being and life in order to be as cheerful and not to suffer from constant pain. And I do not want to feel like I’m not worthy of anything. I want to be healthy and alive, Give me this opportunity!