FDA Turns Its Back on Women

July 23, 2020

FDA to ban a hormone that protects women from cancer. Action Alert!

As we recently reported, the FDA is gearing up to issue a ban on compounded bioidentical hormone replacement therapy. The newest development is a report from the National Academies of Sciences, Engineering, and Medicine (NASEM), which falsely concluded that these critical medicines used by millions of women are a “public health concern.” We must use every avenue available to fight the FDA and prevent a ban on estriol, progesterone, and other compounded bioidentical hormones.

The NASEM report was likely all part of the FDA’s ploy. NASEM’s mandate was to impartially review the “clinical utility” of treating patients with compounded bioidentical hormone replacement therapy (BHRT), yet the committee recommended that an FDA panel review bioidentical hormones for inclusion on the agency’s “Difficult to Compound List.”

This begs the question: What does clinical utility have to do with determining whether hormones are difficult for a pharmacist to compound? How would this group of doctors and researchers at NASEM even know what the Difficult to Compound List is, a relatively obscure regulatory process going on within the FDA? It seems obvious that the FDA made sure this recommendation was included in NASEM’s report.

There’s more evidence that the FDA carefully managed this entire process. You can read our previous coverage for more of those details. All of this together paints a clear picture: the FDA knew how this was going to end before it ever began. With an “impartial” report from the “experts” at NASEM, the FDA has given itself cover to ban compounded BHRT.

Hormones like estriol are critically important. Many studies have shown that estriol offers many potential health benefits—for urinary tract and bone health, for example—without some of the dangers that accompany higher-potency estrogens, such as cancer. A ban would cause suffering for many, many women. But banning compounded bioidenticals could have even wider implications—the FDA is trying to make it impossible for traditional pharmacies to stay in business. Many pharmacies rely on compounded hormones to stay open. If a ban does go through, pharmacies that manage to stay open will still have to grapple with all of the other draconian measures that are coming out of the FDA that severely limit interstate sales and savagely cut the type of ingredients that can be used in other medicines—safe natural medicines like curcumin, aloe vera, boswellia, and a host of others are likely to be banned from being made at traditional pharmacies.

It’s time to fight back.

Currently there is a request for comment at the FDA’s Office of Women’s Health (OWH) asking for input on what the office’s strategic priorities should be. According to the announcement: “To maximize FDA OWH’s ability to promote, protect, and advance the health of women, we are seeking input on research priorities driven by data gaps and areas of unmet need.”

Since NASEM concluded that there was insufficient “high-quality” evidence to determine the safety and effectiveness of estriol and other compounded hormones, perhaps the agency should put its money where its mouth is and support third party studies on compounded BHRT—clearly the FDA cannot be trusted to conduct any studies on the subject.

We should not let this opportunity to officially demand this research pass—a strong showing from patients and other concerned individuals can also demonstrate how many Americans care deeply about this issue and are fed up with the FDA’s hostility towards these treatments.

Attacking estriol and compounded hormones is just one of the ways the FDA and the federal government bolster drug monopolies and undermine natural health options. Taking action below sends a message to FDA’s OWH and also adds your name to our petition demanding that Congress reform a healthcare system that not only bars the use, but even the mention, of natural remedies like compounded bioidentical hormones that have not been, and never can be, put through the multi-billion dollar FDA approval process, because as natural substances they cannot be fully patented.

Action Alert! Sign our petition to reform our broken healthcare system, and send a message to OWH that they need to prioritize funding studies of compounded BHRT to protect women’s health. Please send your message immediately.

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110 responses to “FDA Turns Its Back on Women”

  1. Hillary Oshea says:

    Thanks.

  2. Ida DelVecchio says:

    USED TO TRUST THE FDA, BUT DON’T ANYMORE. THE DRUG INDUSTRY REALLY RUNS THE FDA AND ANYTHING THAT WON’T MAKE THEM PROFITS AND HAVE EXCLUSIVITY IS SENT PACKING WITHOUT ANY REAL INVESTIGATION. THE AMA AND THE DRUG INDUSTRY HAVE IMPEDED ANYTHING THAT MIGHT HELP PEOPLE LIKE MIDWIVES ETC FROKM BEING, SO THEY COULD RAKE IN THE $$$$$. YOU’RE A BUNCH OF GREEDY HYPOCRITS

  3. Jaszmene Smith says:

    Banning the medicine for women is like their murdering these women for payment lift the ban or suffer the consequences.

  4. Tanya Piker says:

    FDA , you could care less about anyone. It is all about the dollar in your book.

  5. Renee Woodman says:

    DO NOT hurt women’s health!

  6. Colleen McKie says:

    The good old boy regime strikes again…

  7. Fay Payton says:

    Women’s health needs to be a top priority. Please prioritize funding studies of compounded BHRT. We women are being shortchanged by having even the words like ‘compounded bioidentical hormones’ and other natural remedies. The FDA process that scorns anything that cannot be ‘patented’ is actually not for our benefit. It is to support monopolies. Yet the end result is to harm women, not help us. As an RN, PHN (ret), I am appalled that the FDA has veered sharply to supporting Big Pharma rather than attending to it’s actual mission.

  8. Joyce Gibb says:

    I HAVE BEEN ON BHRT SINCE 2012. MALE PATIENTS DO NOT UNDERSTAND WHAT MENOPAUSAL WOMEN GO THROUGH WITH HOT FLASHES, VAGINAL DRYNESS, LEAKY BLADDER, WEAK BONES, WHICH ALL STEM FROM LOW FEMALE HORMONES. I RECOMMEND THAT COMPOUNDING PHARMACY’S SHOULD BE MEMBERS OF NATIONAL COMPOUNDING PHARMACY’S. I ALSO TREAT MANY WOMEN WITH BHRT. THEIR LIVES ARE CHANGED USING THE CORRECT DOSE OF BHRT. THE DOUBLE BLINDED RCT TRIALS WILL NEVER HAPPEN SINCE NATURAL HORMONES CAN’T BE PATENTED. YOU HAVE TO LISTEN TO THE WOMEN OUT THERE!

  9. Alexis says:

    I did this a couple of weeks ago – I get canned responses from some of the politicians that state how the FDA is looking out for us but then saying they will definitely consider my input – I don’t really believe it anymore. FDA is interested in only one thing – profits for criminal (as far as I’m concerned) drug companies! It’s time the FDA itself were banned!

  10. I am a scientist, Ph.D.biochemistry, and this latest assault on women’s right to choose, contradicts what fda/ pharma hiding behind this type of report ignores: your very own suggestion that women and their doctors must honor symptoms and solid data that correlate there.
    Tens of thousands of women report feeling best in their peri and menopausal years using various combinations of established and compounded hormones, notably they feel best on transdermal progesterone… you must learn molecular chemistry enough to be credible here, and not assume that only traditional sanctioned huge randomized trials are applicable to individualized compounding.
    That is patently absurd and false.

    • Carolyne Shapiro says:

      Thank You so much, Phyllis Bronson, for a really wel written response to what is so sadly happening with the FDA — NASEM and the want to do away with our compounded bioidentical hormones! MANY women — and now men rely on these hormones seriously to live — without them – the quality at least of my life was so so bad that I just did not care any longer and it was not a psychological issue! I needed hormones and I needed them badly! I would learn that not only could I take but I SHOULD have been taking all along and I am a breast cancer survivor x 2 and also a cervical cancer survivor with a rad hysterectomy as well ( 2003, 2005, 2007). Since starting hormones — compounded bioidentical hormones, my breast cancer numbers went from 9 to 2 so they went down and not up as my PCP was so adamant would never happen. To take away our hormones — our right to choose what it is we take and to dimiss the hard work of many fine and well-educated physicians who have made menopause their life’s work and specialize in to me is completely unfair. I believe I speak in the behalf of many women who choose this method of hormone delivery. Again, thank you Phyllis so much for an excellent reply. I am righ there with you. Sincerely and most respectfully to all invoved.

  11. Mari Mennel-Bell says:

    Hormones like estriol are critically important. Many studies have shown that estriol offers many potential health benefits—for urinary tract and bone health, for example—without some of the dangers that accompany higher-potency estrogens, such as cancer. A ban would cause suffering for many, many women. But banning compounded bioidenticals could have even wider implications—the FDA is trying to make it impossible for traditional pharmacies to stay in business. Many pharmacies rely on compounded hormones to stay open. If a ban does go through, pharmacies that manage to stay open will still have to grapple with all of the other draconian measures that are coming out of the FDA that severely limit interstate sales and savagely cut the type of ingredients that can be used in other medicines—safe natural medicines like curcumin, aloe vera, boswellia, and a host of others are likely to be banned from being made at traditional pharmacies.

  12. Abbie R Bernstein says:

    Please do not ban bioidentical hormones. Women need them.

  13. jill davis says:

    more attacks on women’s health, really?

  14. Crystal Mitchell says:

    I don’t understand why a hormone that protects women from cancer would be banned. We have enough issues already, without adding another.

    • Carolyne Shapiro says:

      I agree. For me not having any hormones in my system for 17 pretty awful years was horrific and I had zero quality of life. When I met the incredible physicians working with women in menopause and prescribing compounded bioidentical hormones, my entire life changed for the better as it did for the people who love me. I came back to life. It is my choice, after really studying all of this out heavily having had two estrogen-positive breast cancers — to take what it is I do. I feel very safe in so doing — my physcian has been treating women now a good thirty years with compounded bioidentical hormones and I trust him. I also trust many of the other physicians all doing the same I have met these past eight years. To take away our choice for one and our hormones for two is highly insensitive and uncaring truly — . We are women, we are strong and we know our bodies and what works and what does not – to take away from us could wel ruin the lives of many and if you feel okay with this so be it — for me, i would not be able to sleep with myself at night knowing that the decision I made affected so so many womn and the quality of their lives and also their choices. The FDA has done some incredible things biut this time in re hormones — not so good. This will hurt many so so sadly as it will hurt the families of as well. Pls — allow women to live and let live.

  15. Trina Unker says:

    Please do not disallow the compounding availability of bio identical hormones. These hormones have improved my bone density, as well as, my mental health. I have been on bio identical hormones for over 20 years, and I have never had a problem or issue with them. To make these drugs unavailable to the public, is a crime!

  16. The positive studies on BHRT for both Men and Women already exist. The evidence that they improve quality of life and do not cause harm is already available. Instead of trying to get new research you should gather the global evidence that ALREADY exists on all bio-identical hormones and present that existing data to these complete idiots that would not know good science or medicine if a truck hit them with it.

    Agreed that this is a Big Pharma / FDA agenda. The truth in medicine can always be discovered by following the money… period! More research is a waste of time. The evidence goes back to 1939… how much more evidence do you need to make your case?

  17. Edwin McGrath says:

    Why are you doing this? Did Bonehead direct you to do this?

  18. Jon Krueger says:

    If a product is good and independent tests show it, it’s good enough for me.

  19. jane seward says:

    I have relied on bio identical hormones for many years. I do not tolerate prescription based synthetic hormones. Any
    action to limit bio identical hormones is a gift to the pharmaceutical industry and does not benefit women.

  20. Evelyn Donica says:

    I have been taking compounded BHRT for over 10 years with good results. Leave the natural medicine alone. I am old enough to take care of my own health and do not need the government to interfere.

  21. Julie Schiffner says:

    My GOD what is happening to this country. The powers that be are willing to give everything over to the domestic
    terrorists blm & antifa along with others but will take choice away from Women to better their own Health.

  22. Yvonne Fisher says:

    This is a shocking development. All women should have access to this hormone for their health and wellbeing. Who are you to decide what we need?

  23. Charlotte Stieren says:

    Please don’t upset my regime. I have been on bio identical hormones since 1994. I am staying very healthy physically and mentally with the supplementation of these since my hysterectomy. I’m living proof these are a positive thing-not harmful in anyway.

  24. Connie Gates says:

    Please allow women to care for their own bodies without males deciding how they should live. Really? Do we say whether or not you can have the medication you want for erectile disfunction???

  25. Yvonne says:

    👍

  26. Debra Wilks says:

    The FDA needs to stop trying to be my Doctor! I have one and she prescribes bioidentical hormones for me. Leave these natural treatments alone!

    • Amy Shapiro says:

      The NASEM committee as well as the FDA are not doctors who specialize in menopause — to take away our choices is really horrible and seriously insensitive — it almost makes us women look like we are so foolish. We are not — we simply know what works. we trust our physicians and we feel well.
      Taking away estriol — estradiol – compounded out for us will result in at least 2.5 million women to 5 million women all have to go back to bed and deal with a quality of life so awful that it really saddens me even think this could happen.
      My father was an amazing physcian, Harvard grad who practiced for a good fifty-two years. he taught me that the primary job of any physcian is to comfort his patient. How can a physcian wel treat a woman so badly in need of him when he has nothing to trat her with? I simply just cannot imagine and am beyond concerned and horrible saddened.

  27. Diane M Stayton says:

    Extensive outside studies must be performed before considering such a ban. The ban would throw thousands of women’s lives/health into chaos and decline. This medicine is essential to the life and well being of many. The FDA appears to not consider the value of women’s physical and mental health in their proposal. I am a 58 year old woman who pays out of her pocket for these hormones and feel my well-being and actual survival in the world is related to being able to take this medicine. Women’s suicides, disabilities and health care treatment will spiral if this medicine is suddenly unavailable. To say a ban is needed because of ‘lack of evidence” seems astonishingly cruel to those who need the hormones.

  28. Catherine says:

    When did the FDA ever protect the public?

  29. Robbie Adams says:

    Stop the FDA from banning natural bioidentical hormone replacement therapy! The FDA is too closely tied to BIG PHARMA who is unable to monetize natural substances and hates the competition. Fund studies by a third party to see the efficacy of natural vitamins and supplements that God placed in the natural world, upon which most of medicine is based.

  30. Cathy Sykora says:

    No. I’ve taken compounded estrogen for years. It doesn’t make sense to block this. You’ll put women’s health back to the days when you administered electroshock therapy. There are few people in the world of medicine who have a better understanding than to say that hormones shouldn’t be administered because it hasn’t been a priority in research.

  31. Maril Adrian says:

    get the government out of our health care!

  32. Lois Christiansen says:

    prioritize funding studies of compounded BHRT to protect women’s health

  33. Jack Campbell says:

    more corporate bull

  34. As an independent community compounding pharmacist with hundreds of BHRT patients, I can assure that these hormones are of great value to my patients. They help them to stay healthy and to feel well! They are essential to quality of life for my patients! As for including them on some “Difficult to Compound List”, what in the world does this even mean? Having been a compounding pharmacist for more than 25 years, I have never even heard of such a list much less do I have any idea of what drugs might be on it.
    I have never been the type of person to believe in or subscribe to conspiracy theories of any kind, but you can bet your boots that there is more to this than meets the eye. Big Pharma doesn’t take too kindly to compounding pharmacists getting a piece of what has traditionally been their big, fat hormone pie. The difference between us and them is that the hormones that we compound actually help people.

  35. Carolyne shapiro says:

    Please do not take our compounded bioidentical hormones away — many of you have a mother – wife, sister, child – grandmother — someone — if they needed would you take them away? For so so many of us women out lives will not be livable and this really is the truth – I had to go 17 long years without and the quality of my life was miserable at best – I had no life.
    The physician I deal with has been doing this now for 50- years — I feel 100% safe AND my breast cancer numbers went down since my starting cBHT — not up — says a lot!!!!!! The other physicians I know and work with have been prescribing also upwards of 20 years. I stil do not quite understand how in your meetngs you did not have any buit one doc who does treat with cBHRT — Dr, Rosensweet who was given 5 minutes to present and no compounding pharmacists. Something seems weird. We badly NEED our hormones for without many of us will simply take to bed as we did prio and not get up sadly.
    There has to be a good way to compromise — for you to take away our hormones takes away not only our hormones, our quality of life but also our CHOICE!!! This is really so very unfair. Pls think about if it was someone you loved. What would you do???
    Having worked in this field myself now a good 8 years I see the suffering and I see the happiness when women are dosed well and safely with cBHT!!!

  36. Danielle Spitz says:

    BHRT is essential to women’s health. Stop protecting Big Pharma and order third party studies to determine the true safety and efficacy of estriol and other compounded hormones.

  37. Darryl Swann says:

    My wife needs these hormones badly. I request you kindly help to help all of the women who take compounded bio identical hormones — I have my wife back now and I trust her physician implicitly.
    Thank you so much.
    D Swann

  38. Mary Ann Dorman says:

    I need to have my medicine (Armour Thyroid) made from natural materials as opposed to taking synthroid (synthesized drug) which my body can’t tolerate. The FDA threatened to stop the drug from being made a few years ago. It would have greatly affected me and led to a lot of suffering for me. Time to regulate the FDA and not allow them to make any money from the drugs they regulate of accept. Then, maybe, there would be some changes for the better and not so many deaths from garbage drugs that are pushed through!

  39. Kelli Trotter says:

    Please do not block compounded bioidentical hormone replacement therapy.

  40. J. Yost says:

    Please, consider allowing compounded bio identical replacement
    Therapy to continue. Learn from the past.

  41. Lynn Costa says:

    I’m sick of the government trying to limit womyn’s choices when it comes to our health! Just because natural remedies cannot be made in a lab does not mean that we should not be allowed to use them. Stop siding w/ big pharma and leave the compounded meds & bio-identical hormones alone! I refuse to use horse piss from pregnant mares where they use these poor mares until they are almost dead & take their foals & leave them to die! This premarin crap can lead to dementia! It needs to be taken off the market & safer hrt be used.

  42. Linda Larrowe says:

    Please stop this madness! This is government and FDA taking over our bodies and freedom to choose.

  43. Susan Vogt says:

    stop screwing over women

  44. LJP says:

    At 62 am still having major hot flashes and other uncomfortable symptoms. Take a small estrogen for 27 yrs. Thankful to have it.

  45. Patricia Mazzoni says:

    Compounded Estriol topical/vaginal cream has been a miracle for me. I suffered from frequent UTIs for years, requiring prescription antibiotics to get rid of. Nineteen months ago, my Urogynecologist put me on 1/2 GM of 0.05 percent estriol topical/vaginal cream twice a week, and I have not suffered even one UTI since then. The compound pharmacy keeps the estriol affordable at $60 per tube, and because it is not as strong as estrogen, it is safe to use. Please, do not ban Compounded Estriol. It is a life saver.

  46. Anne Timmons-Harris says:

    Estradiol has saved my quality of life and reduced pain

  47. Bernadette Belcastro says:

    It is better for women to live in third world countries than it is for women to live in the US. It seems that the government and the FDA are trying to make sure that we do not receive the proper treatments and preventative medicines.

  48. Mary Martha Mitchell says:

    Thanks for letting us know about this. I use these hormones as a 75 yr old. Please keep us posted.

  49. linda letnick says:

    please fund studies of compounded BHRT to protect women’s health

  50. Mary Gaynor says:

    I strongly support funding studies of compounded BHRT because I have been on bio-identical hormones for over 20 years and I want their benefits documented so that other women as they enter menopause can know about them.Their use will save millions of dollars in health care costs for older women and keep them healthy and active well into their later years.And you men out there who are married to them will definitely appreciate and share in those benefits.

  51. Ageha Priest says:

    women need to have hormones that are not total chemically made synthetic hormones, we have a right to organic healthy hormones,this is all a sham to keep women from having what is good and can help them, please stop and make this availiable to all women

  52. d'Anne M says:

    The Only people needed to be involved in medical care, for any woman: the woman and her Doctor.
    All other’s should keep thoughts and ideas to themselves. Part of that would be following the medical professionals and permit the medications They recommend for women and holding big Pharma accountable and tell the FDA to help not harm.

  53. Bill Chaffee says:

    I have wondered about the use of bio identical Hormones to reduce the risk or severity of covid19. The estradiol patch is being studied as a treatment but other hormones need to be studied.

  54. Sue Barnum says:

    Thank you for your work…this compounded drug is life-saving to me!

  55. Stephen Boorsma says:

    The FDA should support third party studies on compounded BHRT

  56. Peter Booth Lee says:

    Attacking estriol and compounded hormones is just one of the ways the FDA and the federal government bolster drug monopolies and undermine natural health options. Taking action below sends a message to FDA’s OWH and also adds your name to our petition demanding that Congress reform a healthcare system that not only bars the use, but even the mention, of natural remedies like compounded bioidentical hormones that have not been, and never can be, put through the multi-billion dollar FDA approval process, because as natural substances they cannot be fully patented.

  57. Gregory Beck says:

    I am fully in support of bioidentical hormone replacement therapy and pharamcy (particularly small ones) being able to compound these safe and effective hormones. The FDA should work to keep these pharmacies in business rather than add to the Big Pharmaceutical oligopolies.

  58. Sara Guettel says:

    Three doctors I have seen over the past 15 years have all prescribed BHRT and helped me get my life back from being very ill due to undiagnosed Hashimoto’s thyroiditis. All three knew that all hormones must be balanced and they prescribed bi-estrogen compounded medication including estradiol and estradiol, as well as my thyroid medication, DHEA, and vitamins and minerals which were extremely low due to the undiagnosed Hashimoto’s for so long. They knew I needed these hormones along with compounded progesterone and others. Big Pharma wants to ruin my life so that they can crush compounding pharmacies, using plant based hormones, which stand in the way of them making billions and billions more. I’m tired of the greed and I’m tired of the misogyny. I will do anything I am asked to try to stop these people from ruining my life.

  59. Tina Lucas says:

    Bio identical progesterone had a massive impact upon my health and well being. I would like this option to be available to my daughters one day.

  60. James Robertson says:

    My best friend and my mom just went through cancer treatments. Don’t destroy their progress.

  61. Harry & Teri Frey says:

    It is way past time to fund studies of compounded BHRT to protect women’s health & fix our broken healthcare system.

  62. Miriam Stewart-Thompson says:

    Cant fill in your petition it won’t except my post code

    • ANH-USA says:

      Hi Miriam,

      Thank you so much for your support!

      If you have an international zip code then you unfortunately won’t be able to send our petition. Congress and the FDA will only accept signatures on our petition from U.S. registered addresses. We’re so sorry for this inconvenience, but we do have an international counterpart in the UK that often releases newsletters and petitions on similar topics. You can read more about ANH International on their website: https://www.anhinternational.org/.

  63. Wendy I ber says:

    I am outraged at the continuing assault on women’s access to bio-identical hormones. I have been on compounded bio-identical hormones for an uninterrupted 18 years. I have never ever had a negative issue with them, which is more than I can say for pharmaceuticals that I have taken. The OWH must do all in its power to verify how important and necessary bio-identical hormones are to women, and protect our access to these life-enhancing products. I don’t know what my life would be like without them and am terrified to think that can happen. I started out with pharmaceuticals when I went into menopause and never felt well which led me to seek out natural solutions. Talk to us women who have experience with bio-identical hormones. TALK TO US! TALK TO ME!!!

    • Dear Wendy,
      I do want to talk to you PLEASE. I need to speak to you. I am old, and have many problems too many to list but to name just a few … shaking legs and hands, exhaustion with no energy whatsoever after sleeping 8 or more hours a night, I had cancer surgery of my r Ishtar b reas5 on Feb 2, 2018 and stopped the hormones I was taking for 21 years .. I have. Little memory, osteoporosis, neuropathy, scoliosis, degenerative disease of the lumbar spine and sensory alexia due to abnormality of balance and more. I had been dancing Tango for many years until Covid arrived and hope to dance again if I can STOP SHAKING!l

  64. Gary Donovitz MD says:

    As a practitioner specializing in women’s healthcare for 35 years I have found that the quality of like of women is much improved with bio-identical hormones. Non- oral hormones have hundreds of benefits with minimal risk. The FDA has inspected and licensed a number of 503b outsourcing pharmacies that can make these hormones with purity and potency and sterility that rival pharmaceutical manufacturers. I have just completed an IRB study on breast cancer showing a large reduction in the incidence of breast cancer. Women benefit from these hormones and should not have them taken away from a flawed study haphazardly performed by NASAM.

  65. Louise says:

    Please stop trying to take our hormones away, some of us need them to fight cancer

  66. Bharat Adarkar says:

    Reform our broken healthcare system

  67. Elizabeth Fleske says:

    I have been on bio-identicals for close to 20 yrs. I am 76yo, look 20 years younger, and enjoy a quality of life not matched by others my age. I live on a farm, and while others my age, spend their time in a rocker, I am still very active. I have NEVER had any issues related to taking the bio-identicals. I, too, get canned responses from my representatives and am tired of it! I’m not one of the ‘good ole boys’ so I don’t count! The FDA needs to get their facts straight and stop allowing Big Pharma run their agency. That’s not what they are paid to do! They work for the citizens, and women ARE citizens!

  68. N Morris says:

    To Congress and the FDA;
    I have safely used bio-identical hormones (cBHT) like estriol for a number of years along with other natural medicines. I should have every right to choose the natural based medicines for myself and cBHT that is also safely compounded. Unfortunately the FDA is a captured agency and is looking out more for the major pharmaceutical interests vs. the health of individuals. Can any sane person believe that torturing pregnant horses to utilize their urine to make hormones should still be continued in the 21st century along with harmful synthetic hormones. If more people knew how medications like Premarin were made, they would demand justice. We have the right to use of bioidentical hormones (cBHT) and to stop this horrific factory farming of defenseless horses — horrific practice still operating as of 2020. Preganant Mare Urine (PMU) drugs contain impurites and unknown properties that cannot be identified. Bio-Identical hormones are regarded by many medical professionals to be much safer while not involving the use and abuse of horses to produce them. While more generic derived estrogen is produced now, it is not an option for those wanting to use bioidentical hormones (cBHT). Further the Lancet published last year a study showing that the use of synthetic hormones and PMU hormones increased the risk of breast cancer in women. See The Lancet article: Articles| Volume 394, ISSUE 10204, P1159-1168, September 28, 2019 “Type and timing of menopausal hormone therapy and breast cancer risk: individual participant meta-analysis of the worldwide epidemiological evidence.”

    The FDA allowed drugs in the past like Vioxx to be used, and this drug was only pulled after it was shown to have caused over 40,000 deaths. The FDA makes serious mistakes. Removing our option to choose Bioidentical hormones like Estriol from people who need it will be a serious mistake for thousands of women.

    Congress must protect our rights to the use of Bioidentical medicines (cBHT) and other natural medicine remedies. To concur with others: “Attacking estriol and compounded hormones is just one of the ways the FDA and the federal government bolster drug monopolies and undermine natural health options. The FDA is trying to create insurmountable barriers to access homeopathic medicines. The FDA and FTC and some state’s attorneys general have also recently told doctors they can’t advise both their patients and the public about natural prevention and treatment for COVID-19. This is unacceptable.”

    “Congress must reform our healthcare system that not only continues to bar the use, but even the mention, of natural remedies like compounded bioidentical hormones that have not been, and never can be, put through the multi-billion dollar FDA approval process.”

  69. Karen White says:

    Keep medical matters between a woman and her doctor. My daughter feels human again since being on this hormone.
    A doctor has written of the benefits to women. The FDA needs to move with the times.

  70. M. Ridgely says:

    The public is getting tired of the harms caused by more and more of the FDA approved drugs, while the FDA – at the urging of the multi-billion dollar drug and medical industry – is blocking natural approaches to health. The FDA is supposed to work FOR the people of the United States of America – not corporations!!!

  71. Deborah Shonk says:

    Please do not ban BHRT hormones for women. I, like so many others, are starting go to get a great quality of life back after years of failing health. After my hysterectomy my quality of life and health declined. I started BHRT and am starting to feel better. Please do not take our health from us by banning BHRT.

  72. Linda Williams says:

    Is this the same FDA that allowed the original polio injections to be given, knowing some of them contain a carcinogenic agent? Oh yes, I trust them. HA!! Don’t think so, especially since the cancer rate in my high school class is very high.
    I trust my doctor to make the right decision, not the FDA.

  73. Virginia Brooks says:

    I am 83 years old and have been using bioidentical compounded estrogen (estrone, estradiol, estriol) topical cream for 30 years, plus or minus, long enough so that I don’t remember exactly when I began using the cream. Detailing the horrible effects of menopause caused by a low amount of estrogen in my body isn’t necessary – other petitioners have done a pretty good job of that. That would be pointless anyway, as this threat by the FDA obviously has nothing to do with what is good for women and everything to do with what will make more profits for the commercial pharmaceutical companies. I think that what we have here is an attack on our constitutional rights..

  74. Kimberly Weathersby says:

    Before my Bi-est cream I was having more than 24 hot flashes a day and constant night sweats. The day I made an appointment with my Doctor I had 20 hot flashes my noon. You may think “Oh get over yourself sweetie – and man-up’. No this was debilitating, I could not focus or function at work or home. I started to avoid everyday activities including driving my car and didn’t want to go out in public.
    My Bi-est cream was a game changer, my Doctor worked with me to get the right levels and not some BIG PHARMA telling her what dose to use based solely on weight & height. I have been using bio-identical hormones for over 12 years (yes – that is right 12 years) and my life is the best it has ever been. I use Bi-est, Progest and Testosterone. I am 62 years young, in great shape, sharp mind, in proper weight and all other things healthy (no diseases). Do I attribute them to bio-identical hormones – a lot of it yes. No more hot flashes or night sweats, my bones are strong, no leaky bladder – I feel great.
    If these go away then I refuse to take BIG PHARMA hormones. Will more than likely have to retire – oh by the way I pay a huge amount of taxes – do you want that to go away as well??

  75. Lynn Nutter says:

    We women can’t think for our selves and decide what it best, this is small according to the big picture!! Women do get it RIGHT!!! Don’t mess with our hormones!!

  76. Ann Trotter says:

    Stop interfering with women and men’s health. Stop forcing big Pharma pills for profit on us… compounded bio-identical hormones are life saving for us. WE have the right to decide what is good for us! us and our doctors! Leave your greedy hands out of it.

    These hormones do more good for our health than any pills on the market. Please stop the madness of trying to control our well being when EVERY study, EVERY doctor, EVERY woman knows these are the best medicines for us.

    Stop being greedy.

  77. Brenda Wimberly says:

    Please do not take away BHRT hormones for women. I am doing so much better health wise since I have been on them.

  78. Sherri Cope says:

    I have been on bio identical hormones for over 20 years after having a complete hysterectomy at 35. Please do not take these hormones away.

  79. Lori Sines says:

    We don’t need the FDA or Big Pharma controlling and limiting our options for healthcare. BHRT works, and without the detrimental side-effects of synthetic drugs. It has been a life-saver for so many. Doctors know their patients and prescribe what is best for them. Please do not take away our choices for treatment by banning BHRT.

  80. D. Thoams says:

    Please do not take away BHRT hormones for women (and men). I have been on them for over 5 years and my quality of life has improved greatly!!
    Big Pharma is profiting off of synthetic, harmful and addictive drugs and if you haven’t noticed – assisting in an OPIOID epidemic!! They are not concerned about the health of patients. Shame on you FDA!!!

  81. D. Thomas says:

    Please do not take away BHRT for women or men. I have been taking them for over 5 years and my health and quality of life have improved so much! Big Pharma is not concerned about patients health and quality of life. They create and promote an enormous amount of synthetic and harmful drugs and have assisted in creating an OPIOD crisis!! Why would you let them influence you?

  82. Geri Judd says:

    I was on Premarin and never felt “right” or like myself. I had anxiety, constantly dizzy, no motivation, depressed and just existed. I started compounded estriol/estradiol and feel like my old self again. Just because big pharma gets medications FDA approved does not make them better or safer.

    Don’t take our bioidentical hormones away!!

  83. Amber Higgins says:

    I started BHRT a month and a half ago. Since starting, 1) I haven’t had hot flashes. Prior to starting, hot flashes were causing me major distress several times a day in addition to making it more difficult for me (and my partner) to sleep as I was constantly throwing the covers on and off. 2) I have gone from no desire to have sex and discomfort when having it to actually enjoying it and experiencing no discomfort. 3) I rarely experience pain. Before starting,
    I experienced random aches day and night which had become increasingly debilitating. 4) I experience less anger and depression, and lastly, 5) My eyebrows are growing back.

  84. Michelle Thompson says:

    I can personally say with proof, that if I wouldn’t have come to Dr Andrew with my out of control hormone and thyroid problems, I probably wouldn’t be here today. I physically could not continue on with the synthetic crap they were giving me, my body was slowly dying!Be an advocate for your own health people and research the medicines you’re taking. We can’t take the FDA at face value and most Doctors don’t even know the complications that come with the things they prescribe or the interactions with other drugs you’re own. Not necessarily their fault, they are just listening to the drug reps for those companies. Take back your health, your life and this country, it’s now or never!!!

  85. Robert Schumaker says:

    Since I believe the FDA is run by big pharma (board of directors). I think it should be disbanded.

  86. Joan Torbohn says:

    Please, please do not outlaw Bioidentical Hormone Replacement!!!! Eight years ago I had to have a hysterectomy and my quality of life became unbearable with NO hormones. Then I started on replacement of Estradiol, estriol, testosterone and progesterone from a compounding pharmacy and it was like a miracle!!! I have a full and happy again! Please don’t take them away!

  87. diane cabiness says:

    back in my early 60’s i was having brain fog and extreme energy issues. I went to Hotze clinic and finally got some help.
    the conventional doctors were of no help.

  88. Brenda Hall says:

    It’s all about for the FDA wants you totally dependent on them for your meds and they want you to stay unhealthy
    Because if you feel good they don’t make any money. And they would rather have you sick. There sick people and don’t give a dam about you feeling great and healthy.

  89. Kathryn Gassman says:

    I finally have my life back! Please don’t take it away!!!

  90. Tami Wooldridge says:

    These compounds have been a lifesaver for me. Why ban something that is so helpful?

  91. Joan Scott says:

    I had to have a hysterectomy at 44 years old. The pellets are the only thing that helped me. I tried all the conventional ways, with no help. I’m 68 years old & didn’t discover them until 10 years ago. It changed my life. This is typical of the FDA…

  92. Colleen R Rodrigue says:

    its very important that women have the right to use bioidentical hormones. it changes their life. it has changed mine in a positive way. the FDA should not be taking that away from us.

  93. Dee Pebworth says:

    Hormone replacement is crucial to many women. I am one

  94. Bethany Boley says:

    Please do NOT ban bio identical
    Hormones for women!! I have felt great using these after menopause!!

  95. Jill Fierro says:

    Significant quality of life improvement

  96. Shirley Fredriksen says:

    Bioidentical hormones have been a major part of my health care for many years. They are not covered by insurance. I still need them. They have a positive effect on the quality of my health and well being. I have used all the other HRT options. Bioidentical HRT is by far the best. All efforts by FDA and pharmaceutical companies to eliminate them is about money and we all know it.

  97. I have been using compounded hormones for more than 5 years now. I have found a huge difference in that before using the hormones my brain fog was a problem as was sleep and vaginal dryness. A doctor in Israel told me he had done a lot of research after his young teen son had cancer. After looking at science and reading many medical articles he came to the conclusion that both men and women need a balance in hormones at any age to stay in a state of health. Hormones affect our physical body and emotional body and without them as is usually seen our brain does not focus or function as well without estrogen and our body tissues deteriorate/ dry out, our bones become more brittle- yes we need calcium but hormones also held reduce the road to osteoporosis as we age. I am just a lay individual with a little experience and understanding but do know that the FDA’s attempt to fill their already heavy pockets has nothing to do with the endeavor to keep people healthy. It is a sad sad day when any control over our rights and better judgement is just tossed aside to make another dollar. Please listen to the people who are asking you to reconsider this horrendous change .

  98. Talana L Chang says:

    I also have been using the Hormonal Replacement Therapy since 2012. In 2015, I was diagnosed with Hashimotos Thyroiditis so I stopped using HRT to try and figure out what was going on with my body. I lost all of 2015 to the couch and many doctor appointments. Hashimoto’s is a terrible auto-immune disease that has over 300 symptoms carried with it. So imagine menopause with its horrible symptoms and add a few more hundred on top. Migraines that send you to the hospital, chronic and debilitating fatigue that makes the flu feel like a walk in the park. Pain from the top of your head to the soles of your feet, weight gain, stress impairment, heat intolerance, rashes all over your body that are on fire, and the list goes on and on. I never knew from one day to the next what I would have to deal with. My body defied me in every way. I decided to get back on my HRT pellets and within a few weeks my Hashimoto’s was put into remission. To say that I need my HRT is an UNDERSTATEMENT! I would probably have to be admitted to a padded cell somewhere to deal with all of the MEGA SYMPTOMS! PLEASE PLEASE PLEASE DO NOT TAKE AWAY HRT!!!!

  99. Judy Middlesworth says:

    BHRT PLEASE DON’T TAKE AWAY FROM WOMEN.

  100. LF Streckfuss says:

    Sweet & simple: This is MY choice for MY body, not yours. Do not take away my bioidentical hormones.

  101. Sydney Nicholas says:

    Women are entitled to make a choice regarding BHRT.
    I have never felt better since starting this therapy!

  102. Women are entitled to make a choice regarding any treatments. I choose BHRT. I have never felt better! I have been enjoying BHRT for 15 years.
    Please do not let Big Pharma rule!

  103. Kim says:

    These captured agencies are infuriating. I wish they would go away.

  104. Sandra says:

    No one needs to suffer. BHRT is the only truly solution to relieve female suffering!

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