What’s at Stake in FDA’s Hormone Attack

January 23, 2020

One patient’s story. Action Alert!

We’ve been telling you for a while now about the FDA’s attack on individualized bioidentical hormone replacement therapy, particularly the threat to estriol.

To recap where we are: 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 National Academies of Science, Engineering, and Medicine (NASEM) committee to study the clinical utility of treating patients with compounded bioidentical hormone replacement therapy (cBHRT); 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.

What is often lost in the discussion of the data is the human impact a ban could have. An ANH member, who we will keep anonymous, shared her experience with hormone replacement therapy, highlighting the importance of preserving consumer access to compounded bioidentical hormone replacement therapy.

At age 52, the patient was diagnosed with stage 3 uterine cancer following the rupture of her cancerous ovary. She was forced to have a total hysterectomy and thrown into menopause, with her body no longer making estrogen.

The patient then had six rounds of chemotherapy, leading to severe fatigue and cognitive dysfunction, as well as severe menopausal symptoms, including sleep disruption and hot flashes. She also suffers from Hashimotos and adrenal insufficiency. Her immune function plummeted, allowing several viral infections to reemerge, making her very ill.

The patient’s doctors wanted to “normalize” her function as much as possible, so that they could work on the more serious immune problems. They were particularly interested in her cognitive function and were knowledgeable of the research showing that estrogen can help patients with chronic fatigue, as well as menopausal patients. Her doctors adjusted her thyroid dosage, put her on small amounts of hydrocortisone, and prescribed estriol and progesterone.

At first, her oncologist was concerned about her taking any estrogen, but they reviewed all of the studies and found that estriol, in cream form, is the only estrogen not found to promote endometrial, ovarian, or breast cancer. They found that estradiol, in all of the FDA-approved drugs, would not be safe, and could put her at risk for further cancer. Remember there are no FDA-approved drugs available that offer estriol, so if the FDA decides to ban compounded estriol, patients will completely lose access to this hormone.

As a safety, the patient’s doctor also put her on progesterone to reduce her cancer risk. She currently takes 200-300mg generic Prometrium, which is an FDA-approved drug—but this product contains peanut oil, which is an allergen. The patient has mast cell activation syndrome, which can cause her to have new reactions to substances. If she starts to react to peanuts, as many people do, having access to compounded progesterone, which pharmacists can prepare without unwanted allergens, would be critical.

As a result of her compounded estriol treatment, the awful hot flashes the patient had for four months after her surgically induced menopause immediately went away and have not returned. Over time, her fatigue and cognitive function, including short-term memory, word finding, organization, and executive function have improved.

Now five years out, the patient’s oncologist is extremely impressed with the quality of her vaginal tissue.  He has shared that all of his other patients who have not taken estriol experience dry, shriveled tissue, with painful intercourse. The patient’s primary care doctor wants her to continue on estriol to also help her bones, since she has osteopenia after carboplatin/paclitaxel chemotherapy. Additionally, the patient’s doctors think her skin looks younger and unwrinkled due to the estriol treatment – she’s now 58 and people consistently guess her age to be in the mid-40s. With all of this, her estradiol and estrone levels have been close to zero, and remain so.

The patient let us know that if estriol were taken off the US market, it would leave her with a very difficult choice—to either have all of the awful symptoms again, including decreased cognitive function, or to go out of the US to buy a personal supply. She cannot take the risk of using the FDA-approved estradiol.

This is just one story from the 2.5 million American women who currently rely on compounded bioidentical hormones and who will lose access if the FDA continues on its current path.

Action Alert! Write to Congress and the FDA, telling them to protect access to compounded bioidentical hormones. Please send your message immediately.

26 responses to “What’s at Stake in FDA’s Hormone Attack”

  1. alle adams says:

    my wife has been seriously helped with NATURAL/COMOPUNDED hormones and we will be in trouble should these become unavaiable

  2. James A Clark Jr says:

    protect access to compounded bioidentical hormones.

  3. Patrick McIntosh says:

    Protect hormone medicines alone

  4. E. Mroz says:

    I had to be on hrt because of severe bleeding, cognitive dysfunction and other symptoms when going through menopause. My Dr. is being pressured to get patients off hrt. So I tried and had the usual menopausal symptoms minus the bleeding and increased irregular heartbeats. My Dr. said that for me it’s a matter of quality of life. That’s true for all women on hrt. In whatever form, these compounded hormones need to remain available for those who need them.

  5. DONNA WARNER says:

    IT IS HELPING AND MUST NOT BE DENIED TO DOCTORS AND PATIENTS! YOU ARE SUPPOSED TO HELP HUMANS NOT DENY THEM THE HELP THEY NEED!

  6. Ginger Geronimo says:

    Please protect access to compounded bioidentical hormones.

  7. THIS CANNOT BE OVERSTATED!!! The F.D.A. is notorious for archaic, anachronistic & obsolete enforcement protocols- and ANY measures such as this will DRASTICALLY REDUCE THE QUALITY OF LIVES..!

  8. Joseph A Wieczorek says:

    We do not need FDA to stick their nose into this product!!!

  9. Cathy Barton says:

    Protect access to bioidentical hormones !

  10. Judith Johnson says:

    This is a very important drug and needs to be available to women who need it.

  11. Margaret Christensen says:

    Protect these much needed remedies,

  12. Diana Cobbold says:

    There will be a massive uprising if the FDA refuses to allow compounded bioidentical hormones. Many women are dependent on them for their health and well being. More and more women have learned that their bodies respond well to these compounds and that the FDA-approved medications are unhelpful and cause cancer.

    THE FDA MUST NOT FORBID ACCESS TO COMPOUNDED MEDICATIONS, AS THEY HELP WOMEN TO TAKE THEIR PLACE IN THE WORK FORCE AND ALSO HELP THEM WITH THEIR MARRIAGE AND MOTHERHOOD.

  13. Jacqueline MacLEAN says:

    Compounded bio-identical hormone replacement therapy has given many, many women the ability to live healthy, active lives through the often difficult periods of menopause and post-menopause. The health protective benefits of estriol are well-documented and cannot be denied. Please educate yourselves on this issue before you contemplate denying women their access. Comparative statistics with pharmaceutical (chemical) “hormones” do not share the positive outcomes. Please protect our health and well-being. This is your job!

  14. MaryLou says:

    I am presently taking Estriol from a compounding pharmacy. If I am unable to obtain it, I will NEVER use the dangerous Big Pharma equivalent. I’d rather go without!!!

  15. Dianne Yonan says:

    I wish my doctor would have offered me some bioidentical hormones for my hot flashes and menopause symptoms. I got Estradiol and progesterone, nothing else was offered.

  16. Margit Zink says:

    BIH müssen unbedingt erhalten bleiben

  17. Mary Vandenbusch says:

    The need to retain compounded bioidentical hormones is too great. I use compounded estriol suppositories as one leg of my hormone replacement therapy regimen. It has made such a positive change for me to function and live normally again. Please, do not ban this hormone.

  18. Trina says:

    Please stop interfering with bio identical hormone therapy! It is a life saver for so many people experiencing menopause (and who choose to have their hormones compounded versus taking a synethic version). Furthermore, I feel having the freedom of choice as to which hormone method I prefer should not be dictated by our government.

  19. Ruth says:

    The FDA is for big Pharma NOT the american people. With out my bioidenticals I would go back to extreme fatigue and tortureous formication (itching all waking hours). This strikes fear in me as I dont know what I would do. So tired of the FDAs corruption and greed.

  20. Kathy Davis says:

    The FDA would not be making such arbitrary decisions without Big Pharma putting pressure on them. We need to fight the crux of the problem. I can’t tolerate synthetic hormones and have been on HRT for 22 years.

  21. Marla Farber says:

    Have been on compounded HRT for 20 years. Am almost 80 and people think I am in mid 60s. Has got me out of osteoporosis, hot flashes, made me sleep better’, etc. etc.
    I could go on and on!!

    I PAY FOR THIS MYSELF! MEDICARE DOES NOT! WHY HAVE YOU DECIDED TO TAKE IT AWAY FROM ALL OF US?? WHY??

  22. Martha says:

    Necessary complete hysterectomy (due to mass and tumors). Body went into complete menopause. Which you all know is miserable. Dr put me on synthetic hormones. Stating I was only eligible for 5 months due to high risk. After two weeks I was still homebound. Unable to work, drive, cook all responsibilities. Had absolutely no strength or energy. Dr then doubled my dosage. Still no help. After 6 months and still in bad condition a friend referred me to her dr for bio identical hormone replacement therapy. After two treatments I was on road to recovery. It has truly saved my life. It has now been 10 years. I keep labs up to date as well as mammogram, pep test and dexoscan. I’m now 60 and doing great. Before my surgery I had osteoporosis and on meds and exercise. After starting BHRT it has been reduced to osteopenia. I personally beg of “you” government/ medical field. Do not mess with a proven good product. I could go on for days with all the good things and share cases of friends and relatives whom have had their lives changed due to BHRT. Note to anyone suffering from Parkinson’s disease. You need to check into this treatment. Please don’t mess with a proven good thing for all our health. Why would you wand to go backward in medical science?

  23. Deborah says:

    Estriol is a critical part of many women’s treatment of postmenopausal atrophic vaginitis, bone loss, cognitive changes, mood disorders and in generally looking and feeling well. It is used in Europe to help prevent recurrent breast cancer. It does not predispose to breast, ovarian or endometrial cancers. It does not promote thromboembolic events. WHY IN THE WORLD WOULD THE FDA WANT TO DEPRIVE AMERICAN WOMEN OF THIS NECESSARY TREATMENT? I prescribe it as a physician and use it myself.

  24. Lucy b says:

    I cannot use estradiol alone products for my menopausal symptoms since straight estradiol is to potent for me in even the lowest dose. When adding estriol with my estradiol as in biestrogen cream from a compounding pharmacy , the estriol helps taper down the potency of the estradiol and thusly I can tolerate it much better without unwanted side effects.

  25. Ellen says:

    Please leave estriol alone. Do not take it away from so many patients who have benefitted from using this hormone, myself included. Please leave this up to the patient, pharmacist, and prescribing doctor to decide if this is a treatment that is useful, not from the “powers that be”.

  26. Lynn says:

    Please protect access to compounded bioidentical hormones.

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