FDA: Bioidenticals are “Public Health Concern;” Ban Likely

July 9, 2020

The agency has latched onto this false conclusion from a report it commissioned, and it is another direct threat to estriol and compounded bioidentical hormones’ future. Action Alert!

The FDA’s announcement regarding bioidentical hormones came just hours after the National Academy of Sciences, Engineering, and Medicine (NASEM) released their report reviewing the “clinical utility” of compounded bioidentical hormone therapy (cBHT). Because the report views the widespread use of cBHT as a public health concern, the FDA will likely move fast to ban these critical medicines. It is imperative that we mobilize a strong grassroot response to meet this threat and save access to estriol and other compounded hormones.

To quote the FDA’s announcement on the report release: “Given the lack of high-quality clinical evidence and minimal oversight of cBHT, NASEM concluded that their wide-spread use poses a public health concern.”

This has no factual basis at all.  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. What seems to be underway is an attempt to create drug company monopolies. The result may be that women may not be able to obtain estriol at all, even though estriol protects against cancer.

The report’s conclusion deals a real blow to the future of patient access to cBHT, but it is hardly a surprise. We said before that the FDA stacked the deck against cBHT as the NASEM committee was gathering information. It’s no surprise that the recommendations and conclusions of the report mirror the FDA’s interests.

Specifically, the committee’s recommendations include:

  • Restricting cBHT use to patients with a documented allergy to an ingredient in FDA approved BHT products or a documented requirement for different dosage form.
  • Patient preference alone is not enough to justify cBHT use.
  • cBHT doses should not exceed FDA-approved product dosages.
  • The FDA’s Pharmacy Compounding Advisory Committee (PCAC) should review select hormones for the Difficult to Compound list, including estradiol, estrone, estradiol, progesterone, estriol, testosterone, and the pellet dosage form.
  • The federal government and State Boards of Pharmacy should expand and improve oversight of 503A “traditional” pharmacies to ensure quality standards for every cBHT preparation dispensed.

Again and again in the report, members of the NASEM committee acknowledged that many women express a distinct preference for cBHT, but that this wasn’t enough to justify its use. We can only expect the FDA to parrot this message. It’s a clear signal: we know better than women and their doctors. This is government paternalism at its worst, and it cannot be allowed to stand.

To briefly recap how we got here: 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. ANH-USA and other stakeholders pushed back forcefully against the nomination of estriol and other compounded hormones, so the FDA convened a NASEM committee to study cBHT and aid in the agency’s final determination. Our interpretation: the FDA wants to ban hormones but knew they couldn’t do it quietly due to the large consumer response, so they commissioned NASEM to study the matter and give them cover to ban these hormones.

The FDA still has hurdles to overcome before a ban can be issued: the agency has to issue a proposed rulemaking to add these hormones to the Difficult to Compound List. It’s also possible that the FDA issues draft guidance that restricts the use of cBHT as outlined by NASEM’s recommendations.

The time to send a clear message to Congress and the FDA is now. We beat the FDA when they tried to ban estriol in 2008, and we can beat them again, but only if the entire community rises up and holds the agency’s feet to the fire. We cannot let the federal government interfere with women’s health.

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.

We must demand 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.

Action Alert! Write to Congress and the FDA, telling them that patients have a right to choose the medicines right for them, including cBHT. Please send your message immediately.

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86 responses to “FDA: Bioidenticals are “Public Health Concern;” Ban Likely”

  1. Sapna Nayyar-Pellicane says:

    Please save bioidentical hormones — they help women like me manage peri menopause symptoms and still get regular cycles. Life would be very hard without those therapies.

    • DONNA MARIE says:

      SINCE BEING HOSPITALIZED WITH A SEVERED SPINE OVER ONE YEAR AGO I HAVE BEEN WITHOUT MY BIO-IDENTICAL HORMONE CREME AND I AM A MESS! MY ALLERGIES AND ASTHMA CAME BACK TO HAUNT ME ALONG WITH THE HEAD TO TOE RASH OF HIVES AND ACNE LIKE MY FORMER15-YEAR OLD SELF! THE FEVER.. CHILLS.. PROFUSE SWEAT & B.O. IS DIVINE! PLUS MY NEIGHBORS REALLY ENJOY HEARING MY MOOD SWINGS INTO A RAVING LUNATIC.. & MY SALVATION FROM THIS & MORE IS THE EXTREME FATIGUE! IF ONLY I COULD WALK BETTER I’D SEARCH FOR A NEW DR TO PRESCRIBE IT FOR ME AS MY BLOOD TESTS PROVE I’M A NEEDY CANDIDATE! SOME OF MY DOCTORS ADVISED ME AGAINST IT AS BIO-HORMONES APPARENTLY INCREASE THE RISK OF BREAST CANCER WHICH IS EXTREMELY DOMINANT IN MY MATERNAL FAM HISTORY. HOWEVER.. I’D PREFER TO TAKE THAT RISK RATHER THAN GO WITHOUT SOMETHING THAT HAS BEEN SO BENEFICIAL TO MY HEALTH
      PLEASE DON’T INVADE OUR SPACE AS WE STRIVE FOR TO WELLNESS! I’M SURE I HAVE MORE TO ADD BUT I’M WORN OUT JUST WRITING THIS. THANK YOU FOR LISTENING AND HOPEFULLY HEARING OUR PLEAS!

  2. Sallie Donkin says:

    Let’s get healthy

  3. Jc sobel says:

    Keep it natural and healthy, no drugs

  4. Kim Alexander says:

    I have been using bioidentical hormones for years. I have a right to make that choice for myself. If the conclusion that the FDA would like to use for banning these is that they could be detrimental to our health, then it only makes sense that all cigarettes, cigars, alcohol, pain medicines etc… would have to be banned as well. There’s more illness and death associated with those items than there ever would be with bioidentical hormones. This is simply a push for power and an attempt by the FDA and Big Pharma to minimize the alternatives for women. We have bigger issues to be concerned about. Focus on a real problem.

  5. Rosemary C Agrista says:

    My body MY choice

    • Sandra Mansfield says:

      This is a decision that should be left up to me and my doctor. Not big pharma.
      Stay out of our rights!
      My body my choice!!!!!

  6. Alan Stein says:

    Patients have a right to choose the medicines right for them, including cBHT

  7. Robert Sandgrund says:

    There is no factual basis to the FDA concern. Patients should and must have the right to choose the medicines right for them.

  8. Dan DeNeui says:

    My name is Dan DeNeui. I own 2 compounding pharmacies (503A and 503B) as well as medical clinics that specialize in BHRT. We also have a BHRT training company that is chaired by Dr. Neal Rouzier. We have over 700 providers in our network all having large data bases of patients. We are very interested in joining or organizing in this new fight. Please feel free to reach out. Let’s get this going ASAP.

  9. Sharon says:

    It seems to me that the FDA and the Medical Industry have not been on a campaign to improve health, but to improve their own business by creating their own monopoly in Health care. Health care should not be a business, it should be a public service where we can follow whichever path we choose, and I choose the Naturopathic way! I have been taking Bioindentical Hormones for many years now, I started taking them after a suspicious pap test, and have felt great on them and have had no problems! I also have taken Armour Thyroid for 27 years now, I feel great on them, and the FDA and Medicare are now working to take these away! We do need to speak up to get the health care of our choice, not of the politicians and government! I will do whatever I can to help in this regard. Thank you for your service in this important area!

  10. LINDA ASHWORTH says:

    The way medical doctors prescribe hormones is what is dangerous to women. I have been on bioidenticals for years and feel great because of them. Please let American pick the kind of meds that are right for them.

  11. Cindy Goldman says:

    This attempt to undermine my/my doctor’s ability to choose the medication and form of that medication that is right for me is nothing short of CRIMINAL. I have been using cBHT for more than 5 years, and my quality of life has improved tremendously. I am not able to absorb any other form of Hormone replacement. I demand that I continue to have the ability to purchase the therapy that works best for MY body.

  12. Leslie A Worth-Wilson says:

    Bioidentical hormones have made my life worth living again. Before starting on the regimen I had several debilitating health problems that completely resolved after being on Bioidenticals. Why would anyone want to return a now thriving person, with lab tests to prove the positive results of taking these hormones, to a life of misery. I am now able to lead a productive life, feel great and am not on any prescription drugs with dangerous side effects. My vote is to allow people to have the freedom to choose what makes them feel strong, healthy and a vibrant member of society.

  13. BILL ODELL says:

    In my opinion, and with overwhelming knowledge of how the FDA operates/and who they serve, it would be harmful to the general public and shorten many lives if the FDA succeeded in taking away any cures or treatments that may be beneficial and affordable by most people. Stop lining the pockets of pharmaceutical companies. Take off the muzzles you have on the healthcare professionals. Start respecting lives more than money and power! Repent!

  14. Elizabeth Connors says:

    Compounded bioidentical hormones have been recommended by my doctor for my condition fort over 10 years. My children have similar issues and are being helped by our doctor to address these through compounded identical hormones.

    Please do not complicate our access to these aids.

    It is cruel of the FDA to interfere with the care we receive from our doctor.

  15. Carolyn Johnson says:

    I had life threatening side effects from synthetic hormone replacement medications. I also had serious problems with synthetic thyroid medication.

    I have never had a single side effect from my bio identical medications. I don’t know what I would do without them.

    Please do not take the bioidentical medications off the market. They are critical to my health and my life.

    Thank you for your consideration.

  16. Ira Abrams says:

    I am writing in response to the FDA’s announcement to ban estriol and compounded bioidentical hormones. The FDA is ignoring clinical literature and bowing to inappropriate pressure from drug manufacturers in making this decision. This is putting lives at risk for profits.

    The FDAs concern about bioidenticals has no factual basis at all. 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. What seems to be underway is an attempt to create drug company monopolies. The result may be that women may not be able to obtain estriol at all, even though estriol protects against cancer.

  17. Evelyn Donica says:

    Patients have the right to choose the medicines that are right for themselves, including cBHT! I have been on them for over 10 years with good resules.

  18. Renee Bartol says:

    It is unnatural hormones made from horse urine that causes cancer. Bio-identical hormones are not the same and do not cause problems as long as a doctor knows how to adjust the doses. My hormones are compounded for me and I was allergic to the standard base used by other pharmacies. These hormones cured my hot flashes and other menopausal symptoms. Please do not ban them; we have a right to choose. This is not the Soviet Union.

  19. Mendy Bilbao says:

    I have a right to choose which medications are right for me, specifically Compounded Bio-identical Hormones. Please do not take them away from the public. My therapy has to be adjusted every few months based on my lab results. Hormones are not a one size fits all medication. Please, please do not ban these medications and undermine natural health options. The FDA has already taken away HCG and many peptide therapies. It has been devastating for me and my health.Please keep the Compounded Bio-identical Hormones available as an option for patients.

  20. ann violi says:

    I cannot function without them and still have important stuff to do

  21. Kathy winkler says:

    We have a right to chooses our medicines, including bio identical hormones!

  22. Raymond Steve Hoyt says:

    compounded BHRT is safe and has helped millions of patients, women and men alike. To remove the compounding
    of them would be a tragedy, to say the least… They are molecular copies of our own hormones making them a
    natural replacement for the deficiencies of these hormones. These hormones are part of the Anti-Aging Movement.
    They are what keeps us living a more optimal and longer life.

  23. Linda Beals says:

    Bio-Identical Hormones has helped me maintain hormonal stability and has made my life livable, and manageable. Do
    not ban these medicines.

  24. Suzanne Rodriguez says:

    Patients have a right to choose the medicines right for them, including cBHT.
    Your wife, daughter, sister, mother, YOU have a right to choose the medicine right for you.
    Thank you

  25. Debbie says:

    I am tired of being at the mercy of big pharma. I choose to use more natural products to deal with my hormone regulation, and I believe and trust in my physician’s judgement in prescribing the bio-identical hormone therapy, especially as a breast cancer survivor.

    People need to have more say in their own health care. Leave the options available to the people and allow patients and their caregivers to choose the best approach to each individual’s health needs.

    • Rosemarie Giuffrida says:

      I am also a breast cancer survivor who uses bioidentical estradiol patches and prometrium pills to help with the menopausal symptoms. 12 years breast cancer free, and have been using these hormones for over 7 years. I’m 59, in perfect health, and have no need for any other medications.

  26. Linda Scherrer says:

    I am a post-menopausal female and do NOT wish to use synthetic hormones or cruelly-obtained animal hormones. To have my health care options restricted is unethical and leaves me in a difficult situation with my health and well being.

  27. Jaya says:

    I’m fed up with the constant assault of threats on my personal health freedoms and access to safe alternatives to pharma quackery by corrupt politicians and ignorant drug pushers. Go away. Far away. Try Antarctica maybe. Or, Mars. You do not belong in my life, my doctor’s office and especially NOT my bedroom. Stay in your own lane, dammit! Stop your constant harassing good, honest, tax-paying citizens!

  28. Lalla Brutoco says:

    i am writing to urge the FDA to leave bio-identical hormone prescriptions in the consumer marketplace! I have been taking them for almost 20 years. My body is very healthy. And to discontinue this medicine would be very detrimental to my health. This is a very alarming issue to me!!!
    I pray that you will protect my rights to choose what works for me.

    Go find “The Bad Guys” and oust them. These hormones are certainly NOT the culprit!!???

  29. Chris says:

    To the FDA:
    I am now at the age in which I really need hormones. I want bio-identical hormones from a compounding pharmacist. I have researched this for years and feel very comfortable with my choice. I do not need the FDA to promote Big Pharma over my own self interest in my care. Kindly leave us alone to determine our own health needs. We don’t need your Big Cancer alternatives so that big Pharmaceutical companies can ever increase their control over medicine in the US. I have seen too many good women die from your stuff.

  30. Allen Hahn says:

    Why do we keep hearing about what appears to be the FDA coming down hard on treatments in order to stack the deck for pharmaceutical conglomerates to corner us into only being offered their products? Why won’t Congress impose prohibitions that keep FDA commissioners and employees from accepting positions for 7 years at firms whose products these FDA people are giving a government stamp of approval? Fishy.

  31. Kathy Parks says:

    I have been using Bioidentical Hormone Replacement Therapy since May 2007 through current July 2020. It has been a life saver for me. I do not know what I would have done without it. As a postmenopausal woman I was miserable. It is my right as an American citizen to use whatever drug therapy that my doctor and I think is right for me. Congress needs to reform our healthcare system! The FDA needs to leave natural remedies such as compounded bioidentical hormones and homeopathic medicines alone. These medications have been around for years and are safe and effective! The FDA should spend its time working for the interest of the American people instead of spending time working for Big Pharma’s interest!!!!!

  32. Danny Bowers says:

    Outrageous attempt to limit freedom of choice to serve drug company interests

  33. Mary J Craig says:

    Before using Estrial (estriol) as a lubricant only three times a week and locally, not internally, I have had multiple recurring UTIs that have put my body in very uncomfortable conditions and usually requiring the use of anti-biotics that have put my intestinal system out of balance profoundly.

    If women cannot determine the health needs of their own bodies and only rely on the AMA approved treatments sponsored by their doctors and “big pharm” then surely our country has reverted to barbaric standards of survival. I’ll be damned before I accept any government, board/official, male dominated industry telling me what I can or cannot reasonably use to protect my health.

  34. JIM says:

    Really you think drugs are safer than this I KNOW BETTER DRUGS HAVE FAR GREATER DEATH RATES

  35. Dr. Stacey McLarry says:

    My patients repent on this safe therapy. Patients should have the choice to utilize this safe and effective therapy. Please don’t make it impossible for patients to get their unique, individualized therapy which is not available anywhere other than compounding pharmacies.

  36. Sonia Mavropoulos says:

    The FDA and Big Pharma need to stay out of citizen’s rights to opt for natural therapy! This study was limited, biased and represents the pharmaceutical companies. Over 3000 studies were submitted and less then 20 reviewed.

  37. Juergen Winkler says:

    Patient have the right to chose their healthcare, limited these choices only supports foreign pharmacies, patient will get what they want, if it is better regulated then we can maintain compliance and quality.
    Rethink your strategy?

  38. Judi Nicely says:

    As a nurse practitioner who specializes in bio identical hormones and also as a patient who uses them I am asking that you do not ban natural hormones. I cannot tell you the excellent results I have had with hundreds and hundreds of patients over the last 24 years and with myself. Since these hormones are exactly like what our body produces in their chemical structure there are no side effects and the body utilizes them immediately because it knows what they are. Synthetic hormones made in a lab are not the same. Our bodies don’t like them that’s why they cause cancer and other health issues. This is only about the pharmaceutical companies and money. And I am just so sick of this putting money over people and their health. I’m asking you to not ban these hormones and allow us to choose What we want for our health and not be dictated by the pharmaceutical companies and other organizations that don’t have a clue that I’ve never treated people and don’t really know anything about these hormones. Please do the right thing. Thank you

  39. Mary Kay Beattie says:

    Please do not remove bioidentical compounded hormones. My life is so much better with my compounded bioidentical progesterone.

  40. Susan Burke says:

    DO NOT TAKE AWAY MY RIGHT TO cBHT

  41. Karen says:

    I have used bio-identicals with great success. I avoid synthetics, etc. I would be greatly disappointed if bios were not available. My doctor believes they are far safer than synthetics, which are not only unbalanced, but “one size fits all.” One size fits all is a myth.

  42. Ann says:

    Did anybody else have a problem trying to send the bioidentical alert letter. It wouldn’t let me add my name and address. Also, there wasn’t any info on the addresses to send the letter to…

  43. Nancy Roberts says:

    Patients have the right to choose the medicines that are right for them, including cBHT.

  44. Judy says:

    Patients have the right to choose the medication that’s right for them

  45. marlene wolfe says:

    my dr has prescribed this medication for me there is no reason not to make it available

  46. Kim Cintio says:

    I have been using the pellet for years and it helps me a great deal in many areas of my life. We must not allow the FDA to interfere.

  47. Cathy Larkin says:

    Please DO NOT ban this! Natural is much better than chemicals in my body!

  48. Sandra Kern says:

    My compounded hormones are absolutely critical for my life. Without them I suffer with 32 menopausal symptoms from numb hands to vaginal dryness so severe my skin breaks open and bleeds; and everything else that you cannot imagine. We are all different and what a person needs should be their choice. You don’t know me so therefore you cannot know my body. Please, please leave our compounds alone. No insurance pays for my hormones. So, if I am paying out of my pocket, why should you care.

  49. Maryellen Werstine says:

    Bio-Identical hormones are the best source for HRT. Synthetic hormones are derived from abused and tortured horses and is not fit for humans or the horse. Bio-I are imperative for effective treatment of menopause and other hormone imbalances, and must not be taken off the market. If you want to make a change For the better, then ban Premarin and all synthetic hormones!!!

  50. Nilofar Amier says:

    Natural remedies do not pose a health risk. Do not ban them.

  51. Carol Miettinen says:

    Please do not allow FDA to ban BioIdenticals!!!!

  52. Marcia Cupschalk says:

    To ban Bio-Identicals is ludicrous. What is worse is chemical derived hormones from pregnant Mares. People, for various reasons, require hormone replacment in order to live a normal life. Years ago, Premarin, by Wyeth tried to ban Bio-Identicals because they were losing their bottom line in competition with natural hormones that did not have dangerous side effects. I find it outrageous that some people sit in negative judgement over items that help either because they are paid off or they are ill advised to the facts.

  53. Griffin McMath says:

    Patients, providers, and scientists have a right to choose and work with the medicines that are right for THEM, including cBHT.

  54. Joan Antle-Schmidt says:

    Don’t ban bio identical hormones.

  55. Mai Nguyen says:

    Please allow Bioidentical hormones that are prescribed by incensed providers to patients who need hormone therapy. It is a safer and more precise way to treat patients who go through menopausal changes. Without them, many patients will suffer.

  56. Audrey Toll says:

    I AGREE WITH EVERYTHING WRITTEN HERE. I HAVE BEEN ON BIO IDENTICAL HORMONES FOR ALMOST 30 YEARS. I ORIGINALLY TRIED THE PHARMA MADE ON THE MARKET AND HAD AN AWFUL REACTION. THEY ARE DOWNRIGHT DANGEROUS. TO BE ABSOLUTELY HONEST I AM TOTALLY, THOUGHLY, UNBELIEVABLEY, SHOCKINGLY, DISGUSTED WITH THE ENTIRE GOVERNMENT SYSTEM WHO HAS LITERALLY TAKEN OVER THE LIVES OF MOST AMERICANS. WHAT IS IT THAT YOU ARE REALLY AFTER? IS BIG PHARMA PAYING TO GET THESE BETTER HORMONES OFF THE MARKET? I AM SO ASHAMED OF THE PHILOSOPHY OF THIS COUNTRY THAT I WOULD LIKE TO SEND YOU ALL HOME, GET A REAL JOB AND GO TO WORK LIKE ALL THOSE THAT YOU TAKE FROM!!!!!!

  57. JAMIE Hall says:

    This is nonsense. Patients have a right to choose the medicines right for them, including cBHT.

  58. Denise Edgell says:

    I used bio-identical!! They’ve saved my health; you have no right to take them away. It’s my body and my decision!
    I WILL NOT USE synthetic hormones!
    The concern over hormone replacement is because synthetic hormones are not natural and THEY CAUSE CANCER, not the other way around. Bio-identical match my body’s hormones,, they work with it to heal and balance. To be patented, substances/ medicines have to be at least one molecule off of nature, that one molecule off creates side affects like cancer because it is unnatural in the body’s system. You already know this, and you know bio- identical are associated with lower risks Than any synthetic or animal products are.
    Compounding pharmacists and pharmacies have rules and regulations that they adhere to, they work hard at their jobs and are good at it.
    LEAVE MY BIO-IDENTICAL COMPOUNDING HORMONES ALONE
    Denise Edgell

  59. Russ Olinsky says:

    Bioidentical hormones (cBHT) vs. patented formulas such as Premarin, Prempro, and Provera that are not bioidentical.
    Premarin is made from pregnant mare urine, hence the name. Hormones from pregnant horse urine are not biodentical to human hormones. Banning or restricting use of custom compounded formulas is continuing the trend of allowing foxes in the henhouse. What’s next…banning clinical dose vitamins by limiting them to just RDA’s?

  60. I lost my mother due to her use of synthetic hormones in the 70’s. I myself have used compounded , natural estradiol, testosterone and progesterone for 5 years and have never felt better and had more peace of mind. There is no reason for them to be banned due strictly to the greed of the pharmaceuticals.

  61. Dr. David Baltimore says:

    BioIdental hormones are no harder for a compounding pharmacist to make than
    suppositories. Compounding Pharmacists have been making better, safer hormones for decades. The FDA is fabricating an excuse for the unsuspecting to take them off the market as they continue to compete with the FDA’s cash cow, pharma.

  62. Theresa says:

    No!!!! You cannot take away my right to use these medications! NO!!!!!

  63. Karen says:

    This is another example of big crocked pharma corporations trying to screw us out of what little money we have.

  64. Josy says:

    Outrageous behavior from the FDA/FTC/ NASEM/Federal government & some state attorneys general wanting to ban access to natural treatments such as compounded hormones. It should be OUR right, OUR choice to use those compounded hormones for OUR health, OUR bodies! Not everyone does well with Big Pharma’s drugs that are known to have serious side effects, so there is a need to have natural alternatives such as estriol, & the likes for people that cannot tolerate the harsh drug route. But, It all comes down to MONEY & GREED from big pharma & the likes. It is unacceptable! The federal government should not interfere with women’s right & their health

  65. Carla Neely says:

    My body— my choice! There is no legitimate evidence against these medicines.

  66. Beverly Ward says:

    Please do not allow FDA to ban BioIdenticals!!!!

  67. Jane Koehler says:

    I have been on bio identical hormones for 15 years and I am going on 86 years old. I have a right to choose what I put in my body. Premarin is what should be banned. Hormones should be natural.

  68. Georgia says:

    “Given the lack of high-quality clinical evidence” – Well, that is just a lie.

    “and minimal oversight of cBHT, NASEM concluded that their wide-spread use poses a public health concern” – And that is a presumption of guilt rather than innocence until proven guilty. This makes it sound as though anything that does not have oversight by some federal agency is automatically a health concern.

    That makes the water from my private well and the lettuce from my garden a health concern, and the abundant tomatoes and zucchini I share with my family and neighbors a public health concern.

    It’s bunk. We all know it. We all know that it’s Big Pharma controlling the FDA and their commissioned reports in order to take away personal freedom and rights to choose what we put in and on our own bodies. What has this country, founded on freedom, come to?

  69. Compounded hormones are necessary to ensure appropriate dosing of individual hormones may be administered. Limiting access through proprietary drug formulations does not provide for individual dose determination of hormones. One size does not fit all. Many patients need drug doses that are significantly lower than what is available at the retail pharmacy.
    Additionally individual hormone components are critical. In no way, shape, or forms is Provera recognized frequently as prosterone the same as bio-identical progesterone. Compounded bio-identical progesterone is safer and more readily utilized than synthetic progesterone.
    Testosterone is another hormone which is employed at many dose levels. Proprietary testosterone does not offer there individual dosing.
    Estriol is an estrogen hormone that is specifically a major component of compounded hormone Rx. It is not available is varying doses with proprietary drugs.
    There is no good reason to stop the compounding of hormones except the motivation by various parties to curtail the activity of compounding pharmacies and deny consumers freedom of choice. The NASEM report reads like a political manifesto approved by drug company lobbyists designed to overthrow compounding not a scientific document.

  70. We need to approach this systematcally. Estriol binds to the Beta Receptor – breast protective. Using the basic concept long looked at- the estrogen quotient we need to personally ensure that every woman is protected. The only way to do this is with a compounded personalized dose of biest to each woman. Then using testing and following the offload optimal results we can keep women balanced with the appropriate progesterone dose and safe and healthy. Estriol is used in research now for vaginal atrophy in breast cancer patients-it is all over the pub med literature.

    We will protect BHT and female health.

  71. Kathy Lockenour says:

    I have taken bioidentical hormones for years and have never felt better, I have taken the other crap…yes crap and had many many problems. It should be OUR choice not someone else making that decision for us. A FIRM BELIEVER of better health with BHT.

  72. I agree we will not let them take away cBHRT for women. As the leader in training and research in the field of compounded bioidentical hormones,BioTE Medical was ask to lead the coalition for women’s health and BHRT. Our 5000 practitioners in all 50 states continue to optimize hormones for men and women. We have helped more than 600000 patients with the lowest side effects.
    Be careful responding to imposters like Dan Deneui who have been charged with money laundering and false advertising and failed to show up for their patients at the NASEM meetings.

  73. Kathleen Marx says:

    I should have the right to choose my cBHT.

  74. Carolyne Shapiro says:

    For me — compounded bioidentical hormones given to me by a physician who has been working with compounded bioidentical hormones these past 27 years saved my life!!!! Nothing else helped and I was not living – I was miserable — when we do not replace vital hormones lost we suffer and we suffer badly — with no two women being alike it is neve a one size fits all —- for me it is compounded bio identical hormones I feel 100% safe in using and I had had two estrogen-positive breast cancers!!! My cancer numbers now since being on these hormones have all gone down much to my doctors complete dismay and happiness!!!! Power of choice is huge – it is our bodies for one and we know when something is off and when something is working – for me I take BIest and it works and I feel myslef again and a thriving in my 60 now — if taken away for so so many millions of us we wil not fare well and I know it – that is why so many of us are writing. we love our hormones, we love our doctors and we love the compounding pharmacies who work hard to help us! I very much appreciate your reading this indeed. For many of us to take our compounded hormones away will truly be horrific and we well know it. Thank you o very much.

  75. Louise McKinlay says:

    Many/most/all of us have health issues and seek relief. I take a compound that improves the quality of my life everyday. I can’t image life without it. My life would be severely restricted without it. I’m talking about being able to function.

    Please do not ban these compounds. Do not take away our right to make choices for ourselves.

  76. Paige Romero says:

    It will be a tragedy if bio-identical hormones are not available for many women like myself who have tried every single option on the market and failed. Women and their physicians should have a choice available. By our physicians going to medical school and given the knowledge on bio-identical hormone therapy, they should have options for us including Bio-identical hormones. The only method that has worked for me is a compounded Bio-identical estrogen. I urge you to not take this option away from my doctor to give to me. Thank you

  77. DORA RIDDLE says:

    Women should not be taking horse hormones. We have used bioidentical hormones for years with great success The only reason the FDA would ban bioidentical hormones is because they are working for, or being paid by the drug companies.

  78. Richelle says:

    The only reason the FDA wants to ban biochemical hormones is because it doesn’t make them money. They want to control our health by limiting us to synthetic hormones that cause a host of health problems. The more health issues the more money big pharmacy makes. They don’t care about human life, they only care about big money. Women and their doctors have the right to choose what works best for them. Please do not take away our option to choose natural hormones.

  79. Nathan says:

    We have a constitutional right to bio-identical hormones. There is no basis for a ban of these safe natural substances. A ban would be a violation of our freedom of choice in how we choose to care for our own bodies. HANDS OFF BIO-IDENTICALS!

  80. D. Myers says:

    This is truly an outrageous abuse of power by the FDA and one which will kill many women who rely on these hormones for their well-being and health. The benefits of the hormones overwhelmingly outweigh any negatives. The Big Pharma industry wants to put the compounding businesses out and have patients switch to Big Pharma medicine, but HRT therapy is a sensitive issue and not one size fits all. Had Big Pharma been able to meet women’s needs, there wouldn’t be the need for compounded HRT. This cannot be taken away from women without results. We need as many people as possible to comment before it’s too late. Life is precious and is not a political game by federal agencies.

  81. Karina Gregory says:

    Our lives matter, including our quality of life. We have a choices, once the government gets involved, our lives shorten. Please let us make our own choices for our body, we are just a number to the government. These compounding pharmacies are saving people lives. Don’t take away our freedom.

  82. Eileen Mischianti says:

    I am filled with fear at the threat that access to bioidentical hormonesby Doctor’s prescription could be prohibited, and that I would then be subject to the way I had to live before. Please , please do not do this to us. I could not bear to live feeling that poorly again. We have a right to choose, as do all women who suffer. Someday, it might be someone you love who will be in this position, or you. Help us by preserving our doctors right to inform and help us. It is a terrible way to live when you cannot function. Save our right to choose, along with our doctors, the right solution for our well-being. Thank you.

  83. Eileen Harte says:

    I have been using bioidentical hormones for 20 years. I have not experienced any menopausal symptoms throughout this period of time. I am 67 years old and feel fantastic! I have a right to choose what is best for my body. I have also used homeopathic remedies for myself and my family. I have found them to be safe, effective and balancing for my body health. There are no side effects like those experienced with allopathic synthetic drugs with their long list of potential side effects. DO NOT BAN BIOIDENTICAL HORMONES AND HOMEOPATHICS!!! They provide hope for a balanced body/mind without harm.

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